SpyGlass Pharma, Inc. 10-K

sgp-20251231 Tab l e of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________ FORM 10-K ___________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31 , 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-43105 ___________________________ SpyGlass Pharma, Inc. (Exact name of registrant as specified in its charter) ___________________________ Delaware 83-3044245 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 27061 Aliso Creek Rd. , Suite 100 Aliso Viejo , California 92656 (Address of Principal Executive Offices) (Zip Code) ( 949 ) 284-6904 Registrant’s telephone number, including area code Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.00001 per share SGP The Nasdaq Stock Market LLC Securities registered pursuant to section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No x Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No x Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes o No x Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act. Large accelerated filer o Accelerated filer o Non-accelerated filer x Smaller reporting company x Emerging growth company x If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. o If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. o Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). o Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No x The registrant was no t a public company as of the last business day of its most recently completed second fiscal quarter and, therefore, cannot calculate the aggregate market value of its voting and non-voting common equity held by non-affiliates as of such date. The number of shares of the registrant’s common stock outstanding as of March 1, 2026 was 33,426,557 . DOCUMENTS INCORPORATED BY REFERENCE None 1 Tab l e of Contents Table of Contents Page PART I Item 1 Business 1 Item 1A. Risk Factors 38 Item 1B. Unresolved Staff Comments 98 Item 1C. Cybersecurity 98 Item 2. Properties 99 Item 3. Legal Proceedings 99 Item 4. Mine Safety Disclosures 99 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 100 Item 6. [Reserved] 101 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 101 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 111 Item 8. Financial Statements and Supplementary Data 111 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosures 113 Item 9A. Controls and Procedures 113 Item 9B. Other Information 114 Item 9C. Disclosure Regarding Foreign Jurisdiction s that Prevent Inspections 114 PART III Item 10. Directors, Executive Officers and Corporate Governance 115 Item 11. Executive Compensation 122 Item 12. Security Ownership of Certain Beneficial Owner s and Management and Related Stockholder Matters 139 Item 13. Certain Relationships and Related Transactions, and Director Independence 142 Item 14. Principal Accounting Fees and Services 144 PART IV Item 15. Exhibits, Financial Statement Schedules 146 Item 16. Form 10-K Summary 148 2 Tab l e of Contents SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (the Annual Report), including the sections titled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and “Business,” contains forward-looking statements within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties and are based on estimates and assumptions. All statements other than statements of historical fact contained in this Annual Report, including statements regarding our plans, objectives, goals, strategies, future events, future revenues or performance, financing needs, plans, or intentions relating to product candidates and markets and business trends are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”, “aim” or “continue” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. These statements involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements contained in this Annual Report include, but are not limited to, statements about: n the likelihood of our clinical trials demonstrating safety and efficacy of our product candidates, and other positive results; n the timing, progress and results of our ongoing and planned clinical trials for our current product candidates, including statements regarding enrollment, the timing of completion of trials, and the reporting of data from our current trials, as well as the timing, progress and results of our current and future preclinical studies; n our plans relating to the clinical development of our product candidates, including the size, number and areas to be evaluated; n our estimates regarding the total addressable market for our product candidates; n our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy; n our competitive position and the success of competing products that are or may become available; n the rate and degree of market acceptance by physicians, surgeons and patients, including the perceived clinical utility of our current product candidates and other product candidates we may develop; n the need to hire additional personnel and our ability to attract and retain such personnel; n the timing, scope and likelihood of regulatory filings and approvals for our current product candidates; n our ability to obtain and maintain regulatory approval of our product candidates, including our lead product candidate, the Bimatoprost Drug Pad-IOL System (the BIM-IOL System); n our expectations regarding third-party coverage, reimbursement policies and pricing regulations applicable to our product candidates, if approved; n our plans relating to the further development and manufacturing of our product candidates and any future product candidates; n the impact of existing laws and regulations and regulatory developments in the United States and other jurisdictions; n our ability to maintain compliance with our license agreement with the Regents of the University of Colorado, including efforts to meet the development and commercial milestones thereunder, and otherwise maintain our intellectual property rights thereunder; n our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our current product candidates; n our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for clinical trials and commercialization of our product candidates, if approved; n the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; 3 Tab l e of Contents n our financial performance; n the period over which we estimate our existing cash and cash equivalents and short-term investments will be sufficient to fund our future operating expenses and capital expenditure requirements; n our expectations regarding the period during which we will remain an emerging growth company and smaller reporting company under the Jumpstart Our Business Startups Acts of 2012, as amended (the JOBS Act); and n remediating the material weakness in our internal control over financial reporting. We caution you that the foregoing list may not contain all of the forward-looking statements made in this Annual Report. You should not rely upon forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this Annual Report primarily on our current expectations and projections about future events and trends that we believe may affect our business, operating results, financial condition and prospects. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors, including those described in the section titled “Risk Factors” and elsewhere in this Annual Report. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Annual Report. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. Neither we nor any other person assumes responsibility for the accuracy and completeness of any of these forward-looking statements. Moreover, the forward-looking statements made in this Annual Report relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Annual Report to reflect events or circumstances after the date of this Annual Report or to reflect new information or the occurrence of unanticipated events, except as required by law. You should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Annual Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. 4 Tab l e of Contents PART I Item 1. Busines s Overview We are a late-stage biopharmaceutical company dedicated to transforming the treatment paradigm for patients living with chronic eye conditions through long-acting, sustained drug delivery of approved medicines. Our mission is to significantly improve the lives of patients with chronic eye conditions by developing durable drug delivery solutions that can empower patients and surgeons with confidence in long-term disease control and vision preservation. Our lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), comprising novel, proprietary drug pads attached to our intraocular lens (IOL), is designed to be implanted during routine cataract surgery to reduce elevated intraocular pressure (IOP) in patients who have either open-angle glaucoma (OAG) or ocular hypertension (OHT). The BIM-IOL System is designed to consistently deliver three years of bimatoprost, a prostaglandin analog (PGA) approved for topical use by the U.S. Food & Drug Administration (FDA) in 2001 for the reduction of elevated IOP in patients with OAG or OHT. We are also developing a non-IOL-based, ring-shaped, sustained-release implant with bimatoprost, which we believe could be implanted in a standalone procedure, enable retreatment of patients who have received the BIM-IOL System, and offer extended care to patients with OAG or OHT who already received a prior cataract surgery (these patients who have had their IOLs replaced with artificial IOLs are referred to as pseudophakes or pseudophakic patients). In our first-in-human (FIH) feasibility clinical trial, evaluable patients who received the BIM-IOL System achieved a mean IOP reduction of 37% at 36 months with no product-related adverse events (AEs). 95% of evaluable patients were off all topical IOP-lowering drops at 36 months, which we believe highlights the potential for long-term independence from such medications. In our Phase 1/2 multicenter, randomized, controlled trial, which is evaluating the safety and efficacy of the BIM-IOL System, patients who received the BIM-IOL System in the 78 mcg and 39 mcg dose groups achieved mean IOP reductions of 37% and 36%, respectively, at three months and sustained similar rates of mean IOP reduction at twelve months. 97% of treated patients were off topical IOP-lowering drops at three and twelve months, and the BIM-IOL System was observed to be well tolerated at both three and twelve months. In July 2025, we initiated two registrational Phase 3 trials, each expected to enroll approximately 400 patients across 45 sites. We expect to complete enrollment in 2027 and, pending successful Phase 3 results, we plan to submit a 505(b)(2) New Drug Application (NDA) to the FDA in 2028. There is no guarantee that our trials will produce positive results or be consistent with past trial results, and FDA approval is not guaranteed and the regulatory process may take longer than anticipated. Glaucoma is a chronic, progressive disease that is primarily caused by impaired drainage of aqueous humor–the fluid inside the eye–which can lead to elevated IOP. Sustained elevation of IOP can damage the optic nerve, resulting in permanent vision loss. Despite the availability of numerous medical and surgical interventions, glaucoma remains a leading cause of irreversible blindness. Glaucoma is often asymptomatic and frequently undiagnosed until significant vision loss has occurred. Disease progression after diagnosis is also common due to poor patient adherence to the current standard of care, which involves daily administration of IOP-lowering topical eye drop medications. For example, up to 80% of patients are non-compliant with their prescribed topical medications, and nearly 50% of patients discontinue use within one year 1 . When topical medications fail to adequately control IOP, surgical intervention, such as minimally invasive glaucoma surgery (MIGS), may be recommended. While these procedures can help to manage IOP, they often require separate appointments with glaucoma specialists or cataract surgeons with specialized training. Out of the 10,000 cataract surgeons reported by MarketScope 2025 Global Glaucoma Device Report to be currently active in the United States, we estimate 2 that only one-third perform MIGS procedures routinely, which we define as at least two procedures per month. We believe that this low participation rate is due to several factors, including the need for specialized skills and training, technical discomfort, and workflow disruption. Taken together, we believe there is a significant unmet need for a long-term IOP-lowering therapy that is easy to administer and reduces reliance on patient adherence. The BIM-IOL System is designed to address key limitations of current glaucoma care by enabling all cataract surgeons, not just those trained in MIGS, to treat elevated IOP when performing their routine cataract procedures, thereby reducing the reliance on patient adherence to topical medications in managing IOP. The BIM-IOL System is designed 1 Baudouin et al., Adherence and Persistence on Prostaglandin Analogues for Glaucoma: A Systematic Review and Meta-Analysis, American Journal of Ophthalmology (July 2025) https://doi.org/10.1016/j.ajo.2025.03.025 concluding that suboptimal adherence and persistence with prostaglandin analogues (PGAs) are common, with further decreases over time, and that procedural glaucoma treatments that do not depend on daily patient engagement with topical medicines may be needed. 2 Based on data taken from Definitive Healthcare Report 2023. 1 Tab l e of Contents for long-acting, sustained delivery of bimatoprost over three years, which we believe can reduce or eliminate the need for daily topical medications. In addition, we believe our BIM-IOL System has the potential to triple the number of cataract surgeons who treat OAG or OHT routinely at the time of cataract surgery by providing a solution that seamlessly integrates into the existing procedural workflow. This integration of therapy at the time of cataract surgery–one of the most frequently performed outpatient procedures in ambulatory surgery centers (ASCs) in the United States– 3 can also save patients from having to make additional appointments with glaucoma specialists. By combining a known drug (bimatoprost), a known procedure (cataract surgery), and a known device type (IOL), the BIM-IOL System aims to deliver a solution that addresses both cataracts and elevated IOP in a single, streamlined intervention. We believe this approach positions us to pursue a streamlined regulatory approval process under the FDA’s 505(b)(2) pathway because the active ingredient in our BIM-IOL System, bimatoprost, has been previously approved by the FDA. In general, new drug products, including drug-led combination products, can come to the market in the United States through two FDA regulatory pathways: 505(b)(1) or 505(b)(2), which we describe in further detail in the section titled “Business—Government Regulation.” We note that for drug products, including drug-led combination products, where the active ingredient has been previously approved by the FDA or where there is published safety or effectiveness data that can be leveraged to support an NDA, the 505(b)(2) pathway can potentially be used to streamline the development process. We believe our approach is consistent with regulatory guidance from the FDA and we have communicated our strategy to seek approval via the 505(b)(2) pathway to the FDA. The FDA will ultimately determine our regulatory pathway following the submission of our 505(b)(2) NDA. We anticipate that use of the BIM-IOL System, if approved, will be reimbursed through established reimbursement pathways, including Medicare Part B coverage, and we intend to leverage existing Category I Current Procedural Terminology (CPT) codes for the cataract surgery and apply for a new J-code for the physician-administered drug. By supporting the treatment of two common conditions in a single intervention, we believe our BIM-IOL System could offer a compelling solution that can potentially enhance patient outcomes, simplify care delivery, and support provider economics. We estimate that the total addressable market in the United States for the BIM-IOL System is approximately $13 billion based on the estimated one million glaucoma and OHT patients expected to undergo cataract surgery in 2025 4 , the percentage of patients with glaucoma who have OAG 5 , and the wholesale acquisition cost for iDose TR. We aim to disrupt and expand the well-established glaucoma market by addressing two critical unmet needs: long-term therapeutic durability and improved patient adherence. Our Pipeline We believe our novel drug delivery technology (the SpyGlass Platform) has the potential to significantly improve the lives of patients with chronic eye conditions. The SpyGlass Platform is designed to be used with various well-established, approved medicines, including bimatoprost and other small molecules, providing flexibility to potentially treat a range of conditions in the front and back of the eye. Our pipeline of key programs in development is depicted in the chart below. We retain exclusive worldwide development and commercialization rights to these programs. Our Pipeline We are initially leveraging the SpyGlass Platform to develop two novel drug delivery systems to be implanted into the anterior segment of the eye. Our first system in development comprises novel drug pads attached to our IOL (Drug Pad-IOL System), both of which are non-bioerodible, meaning that these components do not break down and they retain their structure and shape as the system elutes medicine. Our lead product candidate, the BIM-IOL System, is based on 3 Based on 2025 data taken from DefinitiveHealthcare.com 4 MarketScope 2025 Global Glaucoma Device Report 5 According to the National Eye Institute, OAG accounts for approximately 90% of glaucoma cases in the United States. 2 Tab l e of Contents our Drug Pad-IOL System and is designed to consistently deliver three years of bimatoprost. Bimatoprost is a PGA approved for topical use by the FDA in 2001 for the reduction of elevated IOP in patients with OAG or OHT. We believe this product candidate will be regulated by the FDA as a drug-led, drug-device combination product. We recently initiated two registrational Phase 3 clinical trials. We expect to complete enrollment in 2027 and, pending successful Phase 3 results, we plan to submit a 505(b)(2) NDA to the FDA in 2028. Our second system in development is a novel, non-bioerodible, non-IOL-based, ring-shaped, sustained-release implant (Drug Ring System or DRS), which we are initially developing to consistently deliver at least three years of bimatoprost (BIM-DRS). We believe the BIM-DRS could be implanted in a standalone procedure, enable retreatment of patients who had received the BIM-IOL System, and offer extended care for pseudophakic patients with OAG or OHT. This system is engineered to be removable and replaceable, potentially allowing for continuous care over a patient’s lifetime. In ex vivo studies, we have observed compatibility and positioning of the system in the human eye, and animal studies are currently underway. Subject to the outcomes of these animal studies, we plan to advance the BIM-DRS into FIH trials in 2026. Beyond bimatoprost, we are conducting market feasibility and technical viability assessments for the use of our technology to target highly prevalent eye conditions that could benefit from sustained-release drug delivery, including age-related macular degeneration (AMD), postoperative eye care and chronic uveitis. Additionally, our Drug Pad-IOL System is designed to be compatible with most IOL materials and optical designs. While we believe, based on management projections and internal estimates, that 90% of glaucoma patients receive standard monofocal (or single focus) IOLs during cataract surgery, we are designing for a range of optics, including premium IOLs. Our Strengths We believe the success of our efforts will be driven by the following differentiating factors: n Lead Product Candidate with Positive Preliminary and Interim Data through 36 Months. Our lead product candidate, the BIM-IOL System, combines a known drug (bimatoprost), a known procedure (cataract surgery), and a known device type (IOL). To date, this system has demonstrated sustained IOP reduction and visual acuity improvements in both our FIH trial and our Phase 1/2 trial at 36 and twelve months, respectively. In our FIH trial, evaluable patients who received the BIM-IOL System achieved a mean IOP reduction of 37% compared to baseline at 36 months with no product-related AEs. 95% of evaluable patients were off all topical IOP-lowering eye drops at 36 months, which we believe highlights the potential for long-term independence from such medications. In our Phase 1/2 trial, patients who received the BIM-IOL System in the 78 mcg and 39 mcg dose groups achieved a mean IOP reduction of 37% and 36%, respectively, compared to baseline at three months and sustained similar rates of mean IOP reduction at twelve months. 97% of treated patients were off topical IOP-lowering eye drops at three and twelve months. In July 2025, we initiated two registrational Phase 3 clinical trials. We expect to complete enrollment in 2027 and, pending successful Phase 3 results, we plan to submit a 505(b)(2) NDA to the FDA in 2028. There is no guarantee that our trials will produce positive results or be consistent with past trial results, and FDA approval is not guaranteed and the regulatory process may take longer than anticipated. n Consistent and Predictable Drug Delivery Profile. The SpyGlass Platform is designed to enable consistent and predictable drug release over multiple years and deliver therapeutic effect with ultralow doses. Long-term in vitro release studies have demonstrated that our BIM-IOL System delivers bimatoprost in a sustained and consistent manner over multiple years. This is further supported by our FIH trial data, which has demonstrated consistent IOP lowering through 36 months to date. n Utilizes Existing Techniques and Workflows Allowing for Adoption by All Cataract Surgeons. The BIM-IOL System is designed to seamlessly integrate into the existing procedural workflow of routine cataract surgery and does not require the specialized techniques and training needed to perform MIGS procedures. This integration is expected to enable all cataract surgeons to treat OAG or OHT while performing their existing cataract procedures. We believe this approach has the potential to triple the number of cataract surgeons who treat OAG or OHT routinely at the time of cataract surgery, by enabling the two-thirds of cataract surgeons who do not perform MIGS procedures routinely due to the additional training and specialized techniques required. By integrating therapy into a familiar surgical workflow, the BIM-IOL System significantly lowers the barrier to adoption. n Favorable Payor Environment and Well-Established Reimbursement Model. Our reimbursement model is aligned with existing cataract procedure coverage, reimbursement policies, and billing practices. We anticipate that the IOP-lowering aspect of the BIM-IOL System will be covered under Medicare Part B and billed using a new J-code, similar to other physician-administered drugs, which are typically reimbursed at the average selling price (ASP) plus 6%. We do not believe the implantation procedure will require a new procedure code. We 3 Tab l e of Contents believe this creates a compelling opportunity for additional revenue streams for providers and facilities, including ASCs. By facilitating coverage and reimbursement via well-established mechanisms, we believe we will drive broad adoption for surgeons and facilities. n Novel, Proprietary, Scalable and Expandable Drug Delivery Platform. The SpyGlass Platform is designed to integrate approved medicines into sustained-release systems. The platform is designed to be used with various medications, providing flexibility to potentially treat a range of indications. We are initially leveraging the SpyGlass Platform to develop two novel systems to be implanted into the anterior segment of the eye, our IOL-mounted Drug Pad-IOL System and our non-IOL-based DRS. Both systems are designed to enable sustained delivery of medicines to potentially treat a range of conditions in the front and back of the eye, starting with bimatoprost for the reduction of elevated IOP in patients with OAG or OHT. Our Drug Pad-IOL System is also designed to permit other lens configurations, which we believe could expand our addressable market beyond monofocal lenses. We believe the scalability of our platform positions us to address large patient populations with significant unmet need using well-established, approved medicines in a novel format. n Established Team With a Proven Track Record of Developing and Launching Ophthalmic Pharmaceuticals, Drug-Device Combination Products, IOLs, and Products For Glaucoma Surgery. Our team includes serial entrepreneurs and seasoned executives with deep expertise in ophthalmology, drug-device combination products, IOLs, and products for glaucoma surgery. Our founders, Malik Y. Kahook, M.D. and Glenn Sussman, have collaborated on innovative ophthalmic products for over two decades. Our broader leadership team has helped to develop, launch or commercialize several ophthalmic products, including Beovu, Durysta, Izervay, Kahook Dual Blade (KDB), Latisse, Lucentis Pre-filled Syringe (PFS), Ozurdex, Refresh eye drops, Systane Ultra, Travatan Z, and Vuity. Additionally, our commercial team has strong expertise in procedural and buy-and-bill reimbursement models in ophthalmology. Our Strategy We are purpose-built to transform the management of chronic eye diseases through the following key strategic priorities: n Substantially Improve Patient Outcomes Through Use of Known Drugs, Procedures and Devices. The SpyGlass Platform is designed to be used with various well-established, approved medicines, providing flexibility to potentially treat a range of conditions in the front and back of the eye. Our mission is to significantly improve the lives of patients with chronic eye conditions by developing durable drug delivery solutions that can empower patients and surgeons with confidence in long-term disease control and vision preservation. We plan to continue to leverage known drugs, known procedures and known device types to develop and advance the BIM-IOL System, BIM-DRS and any additional future product candidates through preclinical and clinical development. We believe our approach has the potential to expand access to care and improve patient outcomes. n Advance Our Lead Product Candidate Through Clinical Development for Registration. We believe our approach positions us to pursue a streamlined regulatory approval process under the FDA’s 505(b)(2) pathway. In July 2025, we initiated two registrational Phase 3 clinical trials to evaluate our lead product candidate, the BIM-IOL System. Each clinical trial is expected to enroll approximately 400 patients across 45 sites. We expect to complete enrollment in 2027 and, pending successful Phase 3 results, we plan to submit a 505(b)(2) NDA to the FDA in 2028. There is no guarantee that our trials will produce positive results or be consistent with past trial results, and FDA approval is not guaranteed and the regulatory process may take longer than anticipated. n Enable Lifetime Durability to Complement our Lead Product Candidate. We are developing the BIM-DRS, which leverages similar release kinetics as our BIM-IOL System, and which we believe could be implanted in a standalone procedure, enable retreatment of patients who have received the BIM-IOL System and offer extended care for pseudophakic patients with OAG or OHT. This system is engineered to be removable and replaceable, potentially allowing for continuous care over a patient’s lifetime. Subject to the outcomes of our ongoing animal studies, we plan to advance the BIM-DRS into FIH trials in 2026. n Commercialize our BIM-IOL System and Leverage Deep Experience to Facilitate Coverage and Reimbursement and Support Provider Economics. Surgeons and administrators need to have a high degree of reimbursement confidence to be comfortable purchasing buy-and-bill products and managing the reimbursement process. Members of our commercial team have previously built and deployed these market access service models successfully in other buy-and-bill ophthalmology launches. We will utilize that experience to design a robust market access service model for facilities and their administrative staff. We expect this approach to help accelerate adoption and facilitate patient access at launch. We will also leverage our team’s experience of successful ophthalmology product launches using the buy-and-bill business model and its proficiency in 4 Tab l e of Contents educating customers, including ASCs, regarding the benefits of our product candidates and anticipated coverage and reimbursement. n Strengthen Our Global Intellectual Property Portfolio. We have built a robust intellectual property (IP) portfolio covering drug elution, product design, medical methods, and packaging kits. In the United States and certain other jurisdictions, we co-own in-licensed issued patents protecting our pipeline assets that we expect to expire between 2039 and 2043, with additional applications pending across the United States, European Union, Japan, Australia and Canada. We intend to continue to strengthen our IP portfolio through filings for new formulations, dosing regimens, and methods of use, with additional protection from trade secrets and proprietary manufacturing processes. n Opportunistically Evaluate Strategic Partnerships to Maximize Platform Value. Given the potential broad applicability of the SpyGlass Platform across ophthalmic indications, we plan to selectively evaluate strategic collaborations that could accelerate development, expand patient access, or unlock new therapeutic areas. We may also pursue partnerships with organizations that offer other medicines or complementary technologies, commercial infrastructure, or geographic reach. Our Company History and Team SpyGlass Pharma was founded in 2019 by Malik Y. Kahook, M.D. and Glenn Sussman to solve the lack of ophthalmic innovations that capitalize on durable treatment options. The SpyGlass Platform was originally developed in the Sue Anschutz-Rodgers Eye Center at the University of Colorado Anschutz School of Medicine. To bring our mission to life and execute our strategic objectives, we have assembled a seasoned leadership team with extensive expertise in ophthalmology, drug delivery, IOL development and commercialization. Our chief executive officer, Patrick Mooney, has led several launches and commercialization efforts of ophthalmic pharmaceuticals and medical devices. Our co-founders, Malik Y. Kahook, M.D., our president and executive chair of the board, and Glenn Sussman, our chief technology advisor, have been creating ophthalmic innovations together for over 15 years, leveraging their respective clinical and product development skills. Our scientific, engineering and commercial team members have significant experience in the development, approval, commercialization and reimbursement of IOLs, ophthalmic pharmaceutics, drug delivery methods, medical devices for ophthalmic surgery, and buy-and-bill products reimbursed under Medicare Part B, including multiple therapies to treat retinal diseases. Our team has helped develop, launch or commercialize several ophthalmic products, including Beovu, Durysta, Izervay, KDB, Latisse, Lucentis PFS, Ozurdex, Refresh eye drops, Systane Ultra, Travatan Z, and Vuity. We have also engaged a strong team of scientific advisors and leaders in cataract and glaucoma care. Our team is further supported by a strong group of investors that are committed to development of long-term solutions to chronic eye conditions. Since inception, we have raised approximately $200 million in financing with a premier syndicate of investors, including New Enterprise Associates, RA Capital Management, Vensana Capital, Sands Capital, Gilde Healthcare, Samsara BioCapital, Vertex Ventures HC, and Astoria Health Investors. Our Technology and Approach Our mission is to significantly improve the lives of patients with chronic eye conditions by developing durable drug delivery solutions that can empower patients and surgeons with confidence in long-term disease control and vision preservation. The SpyGlass Platform is designed to be used with various well-established, approved medicines, including bimatoprost and other small molecules, providing flexibility to potentially treat a range of conditions in the front and back of the eye. In preclinical studies and clinical trials, systems leveraging the SpyGlass Platform have demonstrated long-term, sustained delivery of established medicines in a manner that we believe is both convenient for patients and accessible to all cataract surgeons. Our first system in development, the Drug Pad-IOL System, leverages the SpyGlass Platform and integrates approved medicines into two drug pads that are fixed to the haptic arms of our single-piece, hydrophobic acrylic IOL. The Drug Pad-IOL System is designed to seamlessly integrate into the existing procedural workflow of routine cataract surgery. In a typical procedure using this system (as depicted in the images below), the proprietary drug pads are securely attached at the haptic-optic junction of our IOL, which is then loaded into a standard IOL injector in the operating room (similar to current IOL preparatory procedures). Using routine cataract surgery techniques, the IOL is then injected through a standard cataract incision directly into the capsular bag of the eye. Once the Drug-Pad IOL System is positioned in the capsular bag, the drug pads remain outside the visual axis and deliver the integrated medicine by 5 Tab l e of Contents diffusion directly into the aqueous humor, which carries the drug to the targeted tissues. We believe the simplicity of the system has a number of benefits as described below. Step-By-Step Process for Preparation and Injection of Our Drug Pad-IOL System The system comprises our single-piece, hydrophobic acrylic IOL and two non-bioerodible drug pads The system is prepared by securing the two non-bioerodible drug pads at the haptic-optic junction of the IOL The system is loaded into a standard IOL injector for delivery to the eye using routine cataract surgery techniques The Drug Pad-IOL System The Drug Pad-IOL System has two non-bioerodible drug pads secured at the haptic-optic junction of the SpyGlass IOL Following cataract extraction, the Drug Pad-IOL System is implanted into the capsular bag of the eye Our lead product candidate, the BIM-IOL System, is based on our Drug Pad-IOL System. The drug pads of our BIM-IOL System are designed to consistently deliver three years of bimatoprost, a PGA approved for topical use by the FDA in 2001 for the reduction of elevated IOP in patients with OAG or OHT. Topical eye drops with bimatoprost have been safely administered to millions of patients worldwide. By combining a known drug (bimatoprost), a known procedure (cataract surgery), and a known device type (IOL), the BIM-IOL System aims to deliver a solution that addresses both cataracts and elevated IOP in a single, streamlined intervention. We believe the benefits of this approach include: n Long-term Drug Delivery That May Improve Outcomes. The BIM-IOL System is designed to provide years of consistent and predictable drug delivery. In our FIH trial, evaluable patients who received the BIM-IOL System achieved a mean IOP reduction of 37% compared to baseline, 95% of evaluable patients were off all topical IOP-lowering eye drops, and 100% of evaluable patients achieved 20/30 or better corrected visual acuity, in each case at 36 months. We believe this long-term, sustained delivery profile can reduce or eliminate the need for daily topical medications, reducing the reliance on patient adherence and offering the potential to improve patient outcomes and reduce the risk of disease progression. n Ultralow Dose and Potential to Improve Quality of Life. The BIM-IOL System is designed to consistently deliver three years of IOP-lowering therapy using less bimatoprost than is contained in a 5mL bottle of topical bimatoprost drops. The ultralow dose reduces daily exposure to the drug which can potentially reduce the risk of AEs. In our FIH trial, the BIM-IOL System was well-tolerated, and no product-related AEs were observed at 6 Tab l e of Contents 36 months. In addition, in our ongoing Phase 1/2 clinical trial, the BIM-IOL System was well tolerated at three and twelve months, in line with third-party data for patients undergoing cataract surgery. Among the 23 evaluable patients in our FIH trial and the 74 evaluable patients in our Phase 1/2 clinical trial treated with the BIM-IOL System, there were few reported rates of ocular hyperemia, a common cosmetic complaint for patients taking bimatoprost eye drops. n Seamless Integration into Existing Surgical Workflow. Our lead product candidate, the BIM-IOL System, is designed to seamlessly fit into the existing procedural workflow of routine cataract surgery and does not require the specialized techniques and training needed to perform MIGS procedures. For example, this system is designed to use the same tools, surgeon workflow and techniques employed during routine cataract surgery, which we believe enables cataract surgeons to seamlessly and concurrently treat OAG or OHT while performing their existing cataract procedures and without learning new skills. We believe this approach has the potential to triple the number of surgeons that treat OAG or OHT routinely at the time of cataract surgery, by enabling the two-thirds of cataract surgeons who do not perform MIGS procedures routinely due to the additional training and specialized techniques required. n Confidence with Established Reimbursement Pathway. As the Drug Pad-IOL System is designed to be implanted during routine cataract surgery, we anticipate that the use of the BIM-IOL System, if approved, will be reimbursed through established reimbursement pathways and we intend to leverage existing Category I CPT codes for cataract surgery. This would significantly simplify reimbursement logistics compared to other implantable glaucoma devices, which often require new CPT codes. We believe that utilizing existing codes can help to ensure consistent pricing and increase provider confidence in reimbursement, which can help to drive demand and adoption, if approved. n Patient Care with Attractive Facility Economics. We believe that the IOP-lowering element of our lead product candidate will be classified as a physician-administered drug, which are typically reimbursed at the ASP plus 6%. We believe this presents an opportunity for providers and facilities, including ASCs, where approximately 90% of cataract surgeries in the United States are performed 6 , to recognize incremental revenue from cataract surgeries. We believe this helps to align the patient care and economic priorities of providers and facilities. n Scalability and Durability. While our lead product candidate, the BIM-IOL System, incorporates a single drug, the SpyGlass Platform is designed to support various well-established, approved medicines, providing flexibility to potentially treat a range of conditions in the front and back of the eye. In addition, we believe our systems can be developed in the future to support drug delivery beyond the three years targeted by the BIM-IOL System. Moreover, our proprietary drug pad technology is compatible with other lens materials and IOL optics, which can potentially expand our opportunity. We believe the breadth of our platform positions us to address large, underserved patient populations with approved medicines in a novel format. We are also developing our DRS to leverage the same core technology as our Drug Pad-IOL System in a non-IOL-based, ring-shaped, sustained-release implant. This DRS is designed to be implanted in a standalone procedure, in the anterior segment of the eye outside the capsular bag, which we believe will help to preserve visual function. This system is engineered to be removable and replaceable, potentially allowing for continuous care over a patient’s lifetime. In ex vivo studies, we have observed compatibility and positioning of the system in the human eye, and animal studies are currently underway. Similar to our Drug Pad-IOL System, the DRS is designed with the capability to deliver various medicines, and we are initially developing the BIM-DRS. In summary, we believe our technology, starting with the BIM-IOL System, has the potential to transform the treatment paradigm for patients living with chronic eye conditions through long-acting, sustained drug delivery of approved medicines. We believe the BIM-IOL System could redefine the current standard of care for OAG and OHT patients undergoing cataract surgery. Beyond cataract surgery, we believe the BIM-DRS has the potential to address longer-term durability and expand our market by enabling surgeons to retreat patients who have received the BIM-IOL System or offer extended care for pseudophakic patients with OAG or OHT. Our Market Opportunity We are currently developing our systems to address the large and well-defined glaucoma market, which we believe is in need of patient-centric innovation. Our lead product candidate, the BIM-IOL System, is being developed for the reduction of IOP in patients with OAG or OHT who are undergoing cataract surgery. There are expected to be approximately five million cataract surgeries in the United States in 2025, which is expected to grow by 3% to 4% per year, according to MarketScope Ophthalmic Market Trends Q2-2025 US Cataract Edition . These procedures will be performed by the approximately 10,000 cataract surgeons reported by MarketScope 2025 6 MarketScope Ophthalmic Market Trends Q2-2025 US Cataract Edition. 7 Tab l e of Contents Global Glaucoma Device Report to be currently active in the United States. The same report estimates that approximately one million of these surgeries will be performed in patients with glaucoma or OHT. Based on the wholesale acquisition cost for iDose TR and the percentage of patients with glaucoma who have OAG 7 , we estimate that the total addressable market for OAG/OHT and cataract patients is approximately $13 billion. In addition, we believe the DRS has the potential to expand our total addressable market by enabling surgeons to retreat patients who have received the BIM-IOL System or offer extended care for pseudophakic patients with OAG or OHT. While the glaucoma treatment market is significant, and surgical options, such as MIGS, are readily available, the adoption of such options among cataract surgeons remains limited. Based on procedure volumes in claims data from Definitive Healthcare, we estimate 8 that only one-third of the 10,000 active cataract surgeons in the United States perform MIGS procedures routinely, which we define as at least two procedures per month. As a result, approximately two-thirds of cataract surgeons in the United States do not perform MIGS procedures routinely despite an estimated 20% of their cataract patients having glaucoma or OHT according to a published research article analyzing cataract patients based on U.S. Medicare claims data 9 . Outside the United States, we believe the market opportunity is equally compelling. According to MarketScope 2025 Global Glaucoma Device Report , an estimated 5.4 million glaucoma and OHT patients are expected to undergo cataract surgeries outside of the United States in 2025. While we will initially focus our commercial efforts in the United States, we have proactively secured IP protection in key global markets with large numbers of cataract surgeries, including western Europe, Japan, Australia, and Canada, which will enable us to expand internationally and increase the market opportunity for our product candidates. Background and Industry Glaucoma Glaucoma is a group of chronic, progressive optic neuropathies characterized by damage to the optic nerve, ultimately leading to irreversible vision loss and, in advanced cases, permanent blindness for approximately 3.6 million individuals. It is the second leading cause of blindness worldwide. There are two primary subtypes of glaucoma: OAG and angle-closure glaucoma (ACG). According to MarketScope 2025 Global Glaucoma Device Report , over 80 million people worldwide are expected to be affected by OAG in 2025. ACG is less common but presents more acutely, often causing rapid and severe increases in IOP that require urgent intervention. According to the National Eye Institute, OAG accounts for approximately 90% of glaucoma cases in the United States, and is typically asymptomatic until significant vision loss has occurred. Multiple factors are contributing to the significant and sustained growth of the global glaucoma market. A primary driver is the aging population, supported by rising life expectancies and increased access to routine ophthalmic care. As individuals age, the incidence of glaucoma and its associated risk factors increases substantially. Primary risk factors for glaucoma include elevated IOP, race, and family history, while additional factors such as diabetes, hypertension, myopia, and certain systemic conditions may further increase risk. According to a published review of the pathophysiology and treatment of glaucoma, elevated IOP is the only known modifiable risk factor for glaucoma progression. 10 Glaucoma can occur at any age but predominantly affects individuals over the age of 40. The progressive disease is largely asymptomatic in its early stages and is often first diagnosed through routine ophthalmic screening or vision assessments at annual health examinations. As the disease progresses, patients may experience peripheral vision loss, blurred vision, and halos around lights. Central vision is typically preserved until the later stages of the disease, which contributes to the fact that many patients remain unaware of their condition until identified during a standard eye exam. Glaucoma is often caused by impaired drainage of aqueous humor, the clear fluid that nourishes ocular tissues and facilitates waste removal from the eye. Aqueous humor is continuously produced by the ciliary body, flows around the iris and through the pupil into the anterior chamber, and typically drains through the trabecular meshwork, Schlemm’s canal, and ultimately the scleral venous sinus. An alternate drainage route is the uveoscleral pathway. 7 According to the National Eye Institute, OAG accounts for approximately 90% of glaucoma cases in the United States. 8 Based on data taken from Definitive Healthcare Report 2023. 9 Terveen et. al, Real-World Cataract Surgery Complications and Secondary Interventions Incidence Rates: An Analysis of US Medicare Claims Database, Journal of Ophthalmology, Volume 2022, Article ID 8653476, https://doi.org/10.1155/2022/8653476 10 Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014; 311(18):1901-1911. 8 Tab l e of Contents Healthy Eye vs. Eye with Glaucoma When the production and outflow of aqueous humor become imbalanced, IOP can rise above the normal range of 10 to 21 mmHg, leading to progressive and irreversible damage to the optic nerve. This damage is largely preventable through timely and sustained reduction of IOP. The angle, located at the junction where the iris and cornea meet, plays a critical role in aqueous humor drainage and can be anatomically open or narrow. In OAG, there is a gradual increase in resistance of trabecular meshwork, whereas in acute ACG, the iris can block the aqueous humor’s ability to reach the trabecular meshwork. OAG typically develops slowly and without noticeable symptoms in its early stages, often detected only through routine eye examinations, but can progress to cause irreversible optic nerve damage leading to peripheral vision loss that may advance to central vision if left untreated. Flow of Aqueous Humor: from the Ciliary Body, around the Lens and Iris, into the Angle Ocular Hypertension (OHT) OHT is high eye pressure without visible damage to the optic nerve. According to MarketScope 2025 Global Glaucoma Device Report , OHT is expected to impact more than 48 million people worldwide in 2025. While OHT does not cause vision loss, it does increase the risk of developing glaucoma, so it is often managed with eye drop medications to lower eye pressure and regular monitoring to check for signs of optic nerve damage. Although OHT can be treated with many of the same treatments and therapies available to glaucoma patients, many interventional devices and approaches, such as MIGS, are not indicated for treatment of OHT. Bimatoprost is currently indicated to treat OHT in both topical and sustained release forms. 9 Tab l e of Contents Management of Glaucoma or OHT and Their Limitations The reduction of IOP is currently the only known modifiable risk factor that has been borne out by large randomized controlled clinical trials to reduce both the risk of developing glaucoma and the progression of existing disease. 11 IOP is typically managed using eye drops containing PGAs, such as bimatoprost, travoprost, and latanoprost to lower pressure. Usually glaucoma patients start with one PGA and their physicians may add other topical eye drops. As the disease condition worsens, patients may seek glaucoma specialists and pursue procedural interventions. Treatment Algorithm for Glaucoma Patients Eye Drops PGAs reduce IOP by increasing the outflow of aqueous fluid from the eyes through uveoscleral outflow, bypassing the trabecular meshwork. PGA eye drops have been approved for medical use since the mid-1990s and generic forms are readily available. Other eye drops include beta blockers, such as timolol, carbonic anhydrase inhibitors, such as dorzolamide, alpha-2-agonists, such as brimonidine, that work to reduce the production of fluid in the eye. Miotics have also been used to increase outflow. Overall, daily eye drops remain the most common method of administering ophthalmic medicines. For example, topical eye drops with bimatoprost, which we are using in our BIM-IOL System and BIM-DRS, have been safely administered to millions of patients worldwide. When used topically, bimatoprost has a well-established safety and efficacy profile and has been demonstrated to lower IOP by approximately 30% 12 . Despite the widespread availability of topical eye drops for the reduction of IOP in patients with glaucoma, these medicines require lifelong daily administration, sometimes multiple times a day. Patient adherence to topical regimens is notoriously poor, particularly in early-stage disease, which is largely asymptomatic. Patients may be dissuaded by the cost, side effects, or impact on daily routines, especially when they do not perceive any improvement in vision. Common side effects of PGAs include hyperemia, or eye redness, change in iris color, discoloration of skin around the eyes and droopiness of eyelids caused by the loss of orbital fat. For example, approximately 45% of patients taking topical bimatoprost drops reported conjunctival hyperemia as a side effect of treatment, based on third party data. 13 Beta blockers have cardiopulmonary risks, and contraindications due to potential systemic exposure. Carbonic anhydrase inhibitors are associated with blurred vision, bitter metallic taste in the mouth, dry eyes, red/irritated eyes, headache, and upset stomach. Common side effects of alpha-2-agonists include dry mouth, red eyes or eyelids, fatigue, low or high blood pressure, blurred vision and light sensitivity. These tolerability issues, combined with the asymptomatic nature of early glaucoma, contribute to poor long-term adherence. Adherence is further compromised by age-related factors such as reduced dexterity, memory impairment, and physical limitations, which make self-administration increasingly difficult. While topical eye drops remain the most commonly prescribed treatment for glaucoma, their effectiveness in real-world settings is significantly limited by poor patient adherence and inefficient drug delivery. According to the American 11 Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014; 311(18): 1901-1911. 12 Lumigan product label. 13 Product Monograph for Lumigan (bimatoprost ophthalmic solution 0.03% w/v), dated November 26, 2018. 10 Tab l e of Contents Academy of Ophthalmology (AAO), up to 80% of patients are non-compliant with their prescribed topical IOP-reducing medications. As shown in the figure below, reprinted from a book published by the Wilmer Eye Institute, nearly 50% of patients discontinue the use within one year and less than one-third remained persistent by the third year. Percentage of OAG Patients on Topical Treatments Over Time Source: Glaucoma: What Every Patient Should Know © 2020 Dr. Harry Quigley and Dr. Mona Kaleem Without regular dosing, patients are at increased risk of disease progression, complications, and irreversible vision loss. Even when patients describe taking their glaucoma drops as prescribed, studies have shown that less than 5% of the administered dose penetrates the eye and reaches the target tissue. 14 These limitations underscore the urgent need for long-acting, procedure-integrated therapies that bypass the challenges of daily eye drop administration to improve long-term outcomes. Interventional Treatments As longer-term interventional treatment options have become more widely available, a growing number of eye care professionals are advocating for earlier, more proactive procedural interventions to prevent vision loss. This shift reflects a broader recognition of the limitations of topical therapies and the importance of sustained IOP control. Procedural options such as selective laser trabeculoplasty (SLT) and traditional surgeries like filtration procedures, invasive trabeculectomy, and tube shunts, are used to create new drainage pathways in the eye to increase aqueous outflow and lower IOP. While SLT, a non-invasive laser procedure intended to change the targeted tissue’s drainage properties, is generally safe and repeatable, about 20% to 30% of patients are non-responders, and its efficacy diminishes in more advanced stages of glaucoma. 15 Filtration surgery, though effective, is more invasive, requiring an outpatient procedure and recovery time. As a result, many patients and providers prefer to avoid or delay invasive surgery, reserving these options for moderate to advanced disease. MIGS products, such as trabecular bypass stents, as well as non-implant angle procedures like goniotomy and canaloplasty, are designed to enhance aqueous outflow and reduce IOP by accessing Schlemm’s canal and downstream collector channels. These procedures are typically performed in the angle of the eye, where the cornea meets the iris, and are considered minimally invasive due to limited tissue manipulation. MIGS can be combined with cataract surgery, often using the same incision, for people with mild-to-moderate OAG. In fact, some MIGS are only approved to be performed in conjunction with cataract surgery. Despite FDA approval of MIGS devices as early as 2012, out of the 10,000 cataract surgeons reported by MarketScope 2025 Global Glaucoma Device Report to be currently active in the United States, we estimate 16 that only one-third perform MIGS procedures routinely, which we define as at least two MIGS procedures per month. As a result, approximately two-thirds of cataract surgeons in the United States do not perform MIGS procedures routinely despite 14 Agrahari, V., Mandal, A., Agrahari, V. et al. A comprehensive insight on ocular pharmacokinetics. Drug Deliv. and Transl. Res. 6, 735–754 (2016). 15 Naito, T.; Nitta, K.; Miki, T.; Narita, A.; Kimura, T.; Ikuno, Y.; Mizoue, S.; Katai, M.; Saito, Y.; Nanno, M.; et al. Two-Year Outcome of Selective Laser Trabeculoplasty for Normal-Tension Glaucoma in Japan: First-Line or Second-Line Selective Laser Trabeculoplasty (FSS) Study. J. Clin. Med. 2025, 14 3459. https://doi.org/10.3390/jcm14103459. 16 Based on data taken from Definitive Healthcare Report 2023. 11 Tab l e of Contents an estimated 20% of their cataract patients having glaucoma or OHT. We believe that this low adoption rate is due to several key factors, including: n Specialized skills and training requirements for angle-based surgery, such as the need for proficiency in gonioscopy and changes in post-operative recovery and care routines; n Technical discomfort , as MIGS procedures require using the nondominant hand for gonioscopy while operating with the dominant hand; and n Workflow disruption , such as patient head tilting, microscope repositioning, and additional post-operative follow-up care, which changes the routine of standalone cataract surgery. We believe these challenges introduce friction into the decision-making process for cataract surgeons. These barriers have hindered broader adoption and prevented MIGS from fully penetrating the cataract surgery market, despite a large population of eligible glaucoma and OHT patients. This underutilization has created a significant gap in care for glaucoma patients undergoing cataract surgery representing a substantial commercial opportunity for a more intuitive, integrated solution. Similarly, novel procedural pharmaceuticals such as intracameral implants offer sustained drug delivery, but present their own limitations. These implants are placed near the cornea and iris, which can result in corneal endothelial cell loss, inflammation, or other complications. Similar to MIGS, non-bioerodible intracameral implants also require specialized training, use of nondominant hand, mid-surgery adjustments of the patient and microscope, and additional post-operative follow-up care. To date, adoption of these implants has been limited. These limitations underscore the need for a less invasive, durable solution that can be deployed earlier in the glaucoma treatment paradigm – bridging the gap between topical therapy and traditional surgery, thus enabling broader adoption across the cataract surgeon community. Cataracts A cataract is a common, progressive ocular condition in which the normally clear lens of the eye becomes clouded, resulting in impaired vision. While age-related changes are the most frequent cause, cataracts can also develop due to hereditary factors, diabetes, prolonged exposure to ultraviolet radiation or other environmental influences, ocular trauma, and the use of certain medications such as corticosteroids. As cataracts progress, patients typically experience blurred or dim vision, increased sensitivity to light and glare, difficulty with night vision, and fading or yellowing of colors. Cataracts are the leading cause of blindness worldwide; however, vision loss is highly treatable with surgery. Cataract surgery is one of the most frequently performed surgical procedures, with an estimated 32 million procedures expected to be performed globally and five million procedures expected to be performed in the United States in 2025. 17 The number of procedures performed in the United States is expected to increase by 3% to 4% per year, according to MarketScope Ophthalmic Market Trends Q2-2025 US Cataract Edition . The procedure involves the removal of the clouded natural lens and replacement with a clear artificial IOL in the capsular bag of the eye to restore vision. IOLs are available in several designs to address different visual needs. Monofocal IOLs, which are the most commonly used, provide clear vision at a single focal distance, typically distance vision, while toric IOLs correct for astigmatism, a condition where vision is blurry because the cornea is or has become irregularly shaped. Multifocal and extended depth-of-focus IOLs can improve vision across multiple distances, reducing dependence on glasses or contact lenses, however these are not typically indicated for glaucoma patients. Ongoing innovation in lens materials and optics continues to expand options for patients, with premium IOLs increasingly addressing both refractive errors (such as astigmatism) and presbyopia (a loss of near vision) in addition to cataract removal. Our Solution – The SpyGlass Platform Our technology is a novel, proprietary non-bioerodible drug delivery platform (the SpyGlass Platform) that is designed to be used with various well-established, approved medicines, including bimatoprost and other small molecules, providing flexibility to potentially treat a range of conditions in the front and back of the eye. We are initially leveraging this technology to develop two novel systems to be implanted into the anterior segment of the eye: our IOL-mounted drug pad delivery system (the Drug Pad-IOL System) and our non-IOL-based, ring-shaped, sustained release implant (the DRS). Both systems are designed to enable long-term, sustained delivery of various medicines and are currently being developed with bimatoprost. 17 MarketScope 2025 Global Glaucoma Device Report. 12 Tab l e of Contents We believe the benefits of our approach present a number of benefits, which are further described in “—Our Technology and Approach”: n long-term drug delivery that may improve outcomes; n ultralow dose and potential to improve quality of life; n seamless integration into existing surgical workflow; n confidence with established reimbursement pathways; n patient care with attractive facility economics; and n scalability and durability. The BIM-IOL System, Our Lead Product Candidate The BIM-IOL System is based on our Drug Pad-IOL System, with drug pads that elute bimatoprost, a PGA approved for topical use by the FDA in 2001 for the reduction of elevated IOP in patients with OAG or OHT. The BIM-IOL System is designed to address key limitations of current glaucoma care by enabling cataract surgeons to treat elevated IOP when performing their routine cataract procedures, thereby reducing the reliance on patient adherence to topical medications in managing IOP. The BIM-IOL System is designed for long-acting, sustained delivery of bimatoprost over three years, which we believe can reduce or eliminate the need for daily topical medications. In addition, the system is designed to seamlessly integrate into the existing procedural workflow of routine cataract surgery, enabling surgeons to deliver sustained IOP-reducing therapy during cataract surgery without altering their surgical workflow, which we believe has the potential to triple the number of cataract surgeons who treat OAG or OHT routinely at the time of cataract surgery. By combining a known drug (bimatoprost), a known procedure (cataract surgery), and a known device type (IOL), the BIM-IOL System aims to deliver a solution that addresses both cataracts and elevated IOP in a single, streamlined intervention. In July 2025, we initiated two registrational Phase 3 clinical trials, each of which is expected to enroll approximately 400 patients across 45 sites. We expect to complete enrollment in 2027 and, pending successful Phase 3 results, we plan to submit a 505(b)(2) NDA to the FDA in 2028. Preclinical Studies We conducted two nonclinical studies in New Zealand White rabbits to evaluate the toxicity and toxicokinetics of the BIM-IOL System. The implant was designed to elute a steady concentration of bimatoprost over three years; thus, only single-dose toxicity studies were conducted. Rabbits were selected due to their anatomical similarity to human eyes and their established use in ocular toxicology. Appropriate controls, including a no-drug implant consisting of silicone pads without drug and for the 39-week study, a standard commercial IOL, were used to differentiate findings related to the surgical procedure from those that were potentially attributable to bimatoprost exposure and/or the presence of the BIM-IOL System. In one study, 15 animals were monitored for 28 days, and in a second study, 20 animals were monitored for 39 weeks, in each case, post-implantation, with assessments including clinical observations, body weights, qualitative food consumption, ocular irritation scoring, ophthalmic observations, IOP measurements, slit-lamp ocular photography, and histopathology blood samples were collected for toxicokinetic evaluation. Aqueous humor samples were collected for bioanalysis. In both studies, a number of expected procedure-related microscopic or ophthalmic findings typically associated with cataract surgery and IOL implantation were observed across all groups, including conjunctival hyperemia, chemosis, ocular discharge, corneal sutures, corneal edema/scars at the incision, a focal wrinkle in the corneal endothelium at the incision, air bubbles in the anterior chamber, vascularization of the corneal incision, transient corneal erosions, corneal edema, aqueous flare/cell, fibrin in the anterior chamber, peripheral anterior synechia, posterior synechia, iris hyperemia, lens capsule haze/lens fiber regrowth, presence of an IOL, vitreous haze, and degraded view of the fundus due to anterior segment changes. The inflammatory response was comparable across the groups in each study, and for the 39-week study, was comparable to the standard commercial IOL control group. Importantly, no bimatoprost-related ophthalmic or microscopic observations were noted. Under the conditions of the pivotal, 39-week, single-dose toxicity study, the no observed adverse effect level (NOAEL) for bimatoprost was determined to be 300 mcg/eye/dose (1000 ng/eye/day in vitro ), which was also the highest dose tested. Following bilateral administration, plasma levels of the bimatoprost and bimatoprost acid remained below the lower limit of quantitation for all samples collected at all time points, indicating no systemic exposure. Additionally, long-term in vitro release studies have demonstrated that our BIM-IOL System delivered bimatoprost in a sustained and consistent manner over multiple years. 13 Tab l e of Contents Consistent Daily Release of Bimatoprost in vitro Maintained Over Three Years First-in-Human Clinical Trial Based on our preclinical results, we designed a FIH trial to evaluate the BIM-IOL System with 75 mcg, 150 mcg and 300 mcg of bimatoprost. We completed enrollment in our FIH trial in June 2022. Trial Design Our single center, ex-U.S. prospective FIH clinical trial in Honduras evaluates the safety and efficacy of the BIM-IOL System in patients previously diagnosed with mild-to-moderate OAG or OHT and a concomitant cataract and who were taking between one and three topical IOP-lowering medications. Enrolled patients were sequentially assigned 1:1:1 into three groups, where patients received a BIM-IOL System containing 75, 150 or 300 mcg of bimatoprost that continuously released a low (1x), mid (2x) or high (4x) dose of bimatoprost per day, respectively. The 23 enrolled patients who met the surgical eligibility criteria received the BIM-IOL System at the time of cataract surgery in one eye after receiving a baseline washout of all IOP-lowering medications. Participants are examined at multiple time points of follow-up, including at one, three, six, nine, 12, 18 and 36 months. Patients will continue to be followed through seven years, and we plan to provide annual updates. Key efficacy endpoints include the assessment of topical glaucoma medication use and measurement of IOP reduction from baseline at each follow-up time. Key safety endpoints include best corrected distance visual acuity (BCDVA), assessment of AEs, and slit lamp examination, each at multiple time points of follow-up, and endothelial cell density at the 12-month follow-up. The overall design of the trial is outlined in the following figure. First-in-Human Trial Design Interim Trial Results at 36 Months At 36 months, 95% of evaluable patients (n=21) were off all topical IOP-lowering drops. In addition, we observed a statistically significant reduction in mean IOP from 25.1 ± 2.5 mmHg at baseline post-washout to 15.9 ± 2.8 mmHg at 36 months (p<0.0001), with a mean IOP reduction of 37% across all doses compared to baseline. 100% of evaluable patients achieved an IOP reduction of more than 20% from baseline and 90.5% (19/21) of evaluable patients maintained an IOP ≤18 mmHg through 36 months. As expected, there was no statistically significant 14 Tab l e of Contents difference in IOP reduction across the three dosage groups tested. The mean IOP observed for each dose group at screening, baseline and each follow-up period through 36 months is summarized in the figure below. Mean IOP Reduction Sustained over 36 Months Across All Doses At baseline, patient vision, as measured by BCDVA, ranged from 20/30 to 20/100. At 36 months, patient vision for 100% of evaluable patients had improved to a BCDVA of 20/30 or better, and 62% (13/21) of evaluable patients improved to a BCDVA of 20/20 or better. The figure below depicts changes in BCDVA across all dose groups from screening to 36 months. Improvement in BCDVA at 36 Months Across All Doses Screening 36 Months n 23 21 20/20 or better 0% 62% 20/30 or better 35% 100% 20/40 or better 48% 100% 15 Tab l e of Contents Overall, the BIM-IOL System was well-tolerated. All AEs that were observed were considered to be related to the cataract procedure and none were deemed to be associated with our product candidate. The figure below depicts all study-eye AEs reported in our FIH trial through 36 months (cumulative), none of which were serious AEs (SAEs). All Reported Study-Eye AEs Across All Dose Groups Through 36 Months Adverse Event n = 23 (%) Related to Product Candidate Dry eye 5 (21.7%) No BCDVA loss of ≥ 2 lines 3 (13.0%) No Blepharitis 1 (4.3%) No Conjunctival chemosis 1 (4.3%) No Conjunctival hemorrhage 2 (8.7%) No Conjunctival hyperemia 1 (4.3%) No Corneal laceration 1 (4.3%) No Corneal scar 1 (4.3%) No Iris prolapse 1 (4.3%) No Meibomian gland dysfunction 1 (4.3%) No Photokeratitis 1 (4.3%) No Phase 1/2 Clinical Trial Based on the results of our FIH trial, we designed a Phase 1/2 trial to evaluate the safety and efficacy of the BIM-IOL System with 39 mcg and 78 mcg of bimatoprost, which are designed to have similar daily release profiles to the 75 and 150 mcg doses in our FIH trial, respectively. The BIM-IOL System in the Phase 1/2 trial is designed to deliver bimatoprost over three years. Our investigational new drug application (IND) for the Phase 1/2 trial of the BIM-IOL System in patients with OAG or OHT undergoing cataract surgery was cleared by the FDA, and we completed enrollment in November 2024. In March 2026, we reported positive topline 12-month data from Phase 1/2 trial of BIM-IOL System as further described below in “Topline Interim Trial Results at Twelve Months” and we plan to provide yearly updates through three years. Trial Design Our prospective, multicenter, randomized, double-masked, controlled Phase 1/2 clinical trial evaluates the safety and efficacy of the BIM-IOL System in patients previously diagnosed with OAG or OHT and a concomitant cataract, who are taking up to three IOP-lowering medications. The trial is being conducted at sites in the United States, New Zealand and Asia. Enrolled patients were randomized into three groups at a ratio of 2:1:1 to receive the BIM-IOL System (78 mcg) with daily administration of artificial tear drops, the BIM-IOL System (39 mcg) with daily administration of artificial tear drops, or a commercially available aspheric monofocal IOL with twice-daily administration of timolol maleate 0.5%, as the control group. The 104 enrolled patients who met the surgical eligibility criteria received cataract surgery in one eye (the study eye) after receiving a baseline washout of all IOP-lowering medications. Patients are examined at two time points (8 and 10 a.m.) for each follow-up visit at two weeks, six weeks and three months, and will continue to be followed through at least 36 months. The primary endpoint of the Phase 1/2 trial is the mean IOP reduction from baseline at multiple time points of follow-up. Secondary endpoints include mean IOP reduction from baseline, mean IOP, time to reintroduction and number of IOP-lowering medications, and proportion of eyes achieving BCDVA 20/40 or better. Safety endpoints include assessment of AEs, endothelial cell density, slit lamp examination, and patient-reported quality of vision, each at multiple time points of follow-up. The overall design of the trial is outlined in the following figure. 16 Tab l e of Contents Phase 1/2 Clinical Trial Design Preliminary Trial Results at Three Months At three months, the BIM-IOL System demonstrated a mean IOP reduction of 37% and 36% in the 78 mcg and 39 mcg dose groups, respectively. IOP reductions were comparable to the control group at three months in both dose groups, as expected. The 78 mcg dose group, which has a similar daily release profile to our intended Phase 3 dose, performed slightly better than the 39 mcg group. At three months, we observed mean IOP reductions of -9.29 mmHg (8 a.m.) and -9.19 mmHg (10 a.m.) for the 78 mcg dose group, -9.64 mmHg (8 a.m.) and -8.70 mmHg (10 a.m.) for the 39 mcg dose group, and -9.63 mmHg (8 a.m.) and -10.24 mmHg (10 a.m.) for the control group. These results demonstrated minimal differences in treatment between the BIM-IOL System and control groups at three months. The mean IOP observed for each dose group and the control group at baseline and each follow-up period through three months is summarized in the figure below. Mean IOP Reduction Sustained over Three Months Across All Doses The BIM-IOL System demonstrated a substantial reduction in the need for adjunctive topical therapy. At baseline, 30% to 37% of patients were not taking topical IOP-lowering medications, but would benefit from pressure reduction. At three months, 98% (49 of 50) of patients in the 78 mcg dose group and 96% (22 of 23) of patients in the 39 mcg dose group were off all topical IOP-lowering medicines. Patients in the control group were on a twice-daily drop of timolol, as prescribed by the protocol, with no additional topical IOP-lowering medications prescribed. BCDVA as measured by number of ETDRS letters also improved as expected. ETDRS, or the early treatment of diabetic retinopathy study, is a standard visual acuity chart used to measure vision characterized by rows of five equally sized letters. As shown in the figure below, the 78 mcg, 39 mcg, and control groups all demonstrated similar improvement, with measures ranging from 76 to 78 letters (approximately equivalent to 20/30 vision) at baseline and improving to 85 to 86 letters (approximately equivalent to 20/20 vision) at three months. At three months, 100% of patients had improved to a BCDVA of 20/40 or better. The consistency of the visual acuity results across the treatment groups underscore the potential of the BIM-IOL System to deliver IOP-lowering without compromising visual performance. 17 Tab l e of Contents Improvement in Mean BCDVA at Three Months In the Phase 1/2 trial, the overall safety results of the BIM-IOL System at three months were comparable to the control group. Only one patient receiving the BIM-IOL System reported allergic conjunctivitis (1/50, 2.0%) and there were no other reports of conjunctival hyperemia. Similar AE rates were observed in the 78 mcg (35.3%), 39 mcg (39.1%) and the control (33.3%) groups. There was one instance of dry eye reported in the 39 mcg dose group that was rated as severe and determined to be unrelated to the investigational product. The AE was resolved without sequelae following a regimen of over-the-counter ocular lubricants. The figure below depicts the most common AEs (defined as 3% or greater incidence in any group) reported in the Phase 1/2 trial through three months (cumulative). Most Common AEs in the Study Eye (≥ 3% in Any Group) in Each Group Through Three Months Adverse Event 78 mcg n = 51 39 mcg n = 23 Control n = 30 n (%) n (%) n (%) Eye disorders 17 (33.3) 8 (34.8) 9 (30.0) Iritis 4 (7.8) 1 (4.3) 1 (3.3) Corneal edema 3 (5.9) 2 (8.7) 1 (3.3) Keratitis 1 (2.0) 0 1 (3.3) Eye pruritus 0 0 1 (3.3) Eye inflammation 3 (5.9) 0 0 Visual impairment (i.e., halos) 2 (3.9) 0 0 Dry eye 0 4 (17.4) 1 (3.3) Visual acuity reduced (BCDVA loss ≥ 10 letters) 2 (3.9) 2 (8.7) 2 (6.7) Corneal defect 0 1 (4.3) 0 Meibomian gland dysfunction 4 (7.8) 0 2 (6.7) Anterior capsule contraction 0 1 (4.3) 0 Vitreous detachment 1 (2.0) 0 1 (3.3) Pterygium 0 0 1 (3.3) Swelling of eyelid 0 0 1 (3.3) General disorders and conditions 0 0 1 (3.3) Impaired Healing 0 0 1 (3.3) Infections (i.e., conjunctivitis, periorbital cellulitis, hordeolum) 2 (3.9) 1 (4.3) 0 18 Tab l e of Contents Additionally, a table of the cumulative ocular AEs, categorized by mild, moderate or severe is below. Notably, only 37 out of 104 (36%) patients across all treatment groups reported any ocular AEs, of which 36 were mild or moderate. None were SAEs. Severity of Cumulative Ocular AEs at Three Months Severity 78 mcg N = 51 39 mcg N = 23 Control N = 30 n (%) n (%) n (%) Cumulative 18 (35.3) 9 (39.1) 10 (33.3) Mild 15 (29.4) 8 (34.8) 8 (26.7) Moderate 3 ( 5.9) 1* 2 ( 6.7) Severe 0 1 ( 4.3) 0 ________________ * The cumulative adverse event rates are based on the number of subjects with reported AEs. The one moderate AE was reported in a subject that had two reported AEs, hence it is not included in the cumulative rates or percentages. Endothelial cell density loss was within the expected range for post-cataract surgery glaucoma patients, with patients receiving the BIM-IOL System demonstrating an average loss of 14.9% compared to 12.1% in the control group. Importantly, endothelial cell density levels remained stable between three and six months. These three-month results informed the design of our Phase 3 clinical trials and reinforced our confidence in the potential of our lead product candidate, the BIM-IOL System. Based on these results and the FIH results, we advanced the BIM-IOL System (78 mcg) into our Phase 3 clinical trials in July 2025. Topline Interim Trial Results at Twelve Months In March 2026, we reported positive topline 12-month data from our Phase 1/2 trial. Evaluable patients in the 78-mcg (N=47) and 39-mcg (N=21) dose groups achieved a 34% and 42% reduction in mean IOP from baseline, respectively, compared to a 35% reduction in the control (N=29) group at 8 a.m. Results were similar at the 10 a.m. timepoint. 98% of evaluable patients (48 of 49) in the 78-mcg dose group and 96% of evaluable patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications. Evaluable patients who received the BIM-IOL System demonstrated vision improvement with 100% (72 of 72) reaching 20/32 or better BCDVA and mean BCDVA of 86 letters (equivalent to 20/20 vision). AE rates were similar across the 78-mcg (41.2%), 39-mcg (43.5%), and control (36.7%) groups. No serious ocular AEs were observed. Phase 3 Clinical Trials In July 2025, we initiated two identical, registrational, Phase 3 clinical trials to evaluate the BIM-IOL System with 78 mcg of bimatoprost, which is designed to consistently deliver three years of bimatoprost. In January 2026, we announced the randomization of the first patients in our Phase 3 trials. Trial Design Each prospective, multicenter, randomized, masked, controlled Phase 3 clinical trial evaluates the safety and efficacy of the BIM-IOL System (78 mcg) in patients with OAG or OHT and a concomitant cataract, who are taking up to two IOP-lowering medications. Both trials are designed to demonstrate noninferiority of the BIM-IOL System to a standard of care commercial IOL plus twice-daily administration of timolol eye drops. Each trial is expected to enroll approximately 400 patients across 45 clinical sites. The trials are being conducted at sites in the United States, New Zealand and Asia. Enrolled patients will be randomized into two groups at a ratio of 1:1 to receive the BIM-IOL System (78 mcg) or a commercially available monofocal IOL with twice-daily administration of timolol maleate 0.5%, as the control group. Enrolled patients who meet the surgical eligibility criteria will receive cataract surgery in one eye (the study eye) after receiving a baseline washout of all IOP-lowering medications. 19 Tab l e of Contents Identical Design for each of the two Phase 3 Clinical Trials (SGP-005 and SGP-006) Informed by our Phase 1/2 data, we have implemented minor protocol modifications to the inclusion and exclusion criteria. Key changes include tightening the baseline IOP range, enrolling patients on up to two IOP-lowering medications, tailoring washout periods based on drug class pharmacokinetics, and standardizing IOP measurement timing. The changes are intended to improve consistency across trial arms. The primary objective of the Phase 3 program is to evaluate and compare the safety, IOP-lowering efficacy, and BCDVA efficacy of the BIM-IOL System versus control in participants with OAG or OHT undergoing cataract surgery. The co-primary endpoints are (1) the time-matched mean IOP change from baseline at 8 and 10 a.m. at two and six weeks and three months and (2) BCDVA of 20/40 or better at 12 months. Secondary outcome measures will also be evaluated, including mean IOP, time to postoperative introduction of IOP-lowering medications, and number of IOP-lowering medications introduced postoperatively. Participants will be followed through 36 months, allowing us to compare long-term safety, efficacy, and durability. Our Phase 3 program is structured to support our regulatory submission, with a goal of submitting a 505(b)(2) NDA to the FDA in 2028. The first patient visit has already been completed, marking a key milestone in our clinical development timeline. We plan to complete Phase 3 enrollment by 2027 and report 12 month data in 2028 and 24 month data in 2029. BIM-DRS In addition to our lead product candidate, we are developing the BIM-DRS. This system leverages the same core technology as our BIM-IOL System in a non-IOL-based, ring-shaped, sustained-release implant. The BIM-DRS is designed to consistently deliver at least three years of bimatoprost and is intended to provide IOP-lowering therapy beyond the initial three-year duration that we are targeting with the BIM-IOL System. This system is designed for anterior segment implantation outside the capsular bag, which we believe will help to preserve visual function. The BIM-DRS is engineered to be removable and replaceable, potentially allowing for continuous care over a patient’s lifetime. We believe this system has the potential to offer a lifetime solution for patients and expand our opportunity to include patients who have already undergone cataract surgery and are no longer candidates for IOL-based interventions. In ex vivo studies, we have observed compatibility and positioning of this system in the human eye. Animal studies are currently underway. Building upon the positive preliminary and interim data reported to date from our FIH and Phase 1/2 trials of the BIM-IOL System, subject to the outcomes of these animal studies, we plan to advance BIM-DRS into FIH trials in 2026. Additional Programs Beyond bimatoprost, we are advancing early-stage programs that target additional highly prevalent chronic eye conditions, including AMD, postoperative eye care, and chronic uveitis. These programs leverage our drug delivery technology and are in preclinical development. Our SPY-004 program is currently exploring proof-of-concept for a small molecule therapy for AMD. Additionally, we have demonstrated in preclinical studies the potential to elute commonly used ophthalmic steroids (such as dexamethasone) and non-steroidal anti-inflammatory drugs for postoperative pain, including post-cataract surgery, and inflammation management, including chronic uveitis. We believe these capabilities position us to potentially serve both chronic disease populations and acute surgical needs, 20 Tab l e of Contents including premium cataract procedures. Our discovery pipeline is depicted in the chart below. We retain exclusive worldwide development and commercialization rights to these programs. Our Discovery Pipeline Additionally, our Drug Pad-IOL System is designed to be compatible with most IOL material and optical designs. While we believe, based on management projections and internal estimates, that 90% of glaucoma patients receive standard monofocal (or single focus) IOLs during cataract surgery, we are designing for a range of optics, including toric IOLs. We believe these enhancements will allow us to tailor our system to diverse clinical and commercial settings, further increasing its market potential. Commercialization We expect to complete enrollment in 2027 and, pending successful Phase 3 results, we plan to submit a 505(b)(2) NDA to the FDA in 2028. There is no guarantee that our trials will produce positive results or be consistent with past trial results, and FDA approval is not guaranteed and the regulatory process may take longer than anticipated. We believe our commercial strategy is straightforward and scalable. Patients with glaucoma and cataracts are primarily over the age of 65, making Medicare the primary payor. Because the BIM-IOL System is implanted during cataract surgery, we expect that our product candidate will be covered through Medicare Part B. Importantly, we do not believe that the implantation procedure of our lead product candidate will require a new CPT code. The BIM-IOL System is implanted during routine cataract surgery, potentially allowing providers to leverage existing Category I CPT codes for cataract surgery. This would significantly simplify reimbursement logistics compared to other implantable glaucoma devices, which often require new CPT codes. We believe that utilizing existing codes can help to ensure consistent pricing and increase provider confidence in reimbursement, which can help to drive demand and adoption. If we obtain marketing authorization for the BIM-IOL System, we anticipate that providers and facilities, including ASCs, will be able to immediately bill the product under a temporary J-code (J3490 or J3590). In parallel, we expect to apply for a Healthcare Common Procedure Coding System (HCPCS) Permanent J-code, similar to Durysta (J7351) and iDose (J7355), which are currently reimbursed at ASP plus 6%, consistent with other physician-administered drugs. This streamlined and favorable buy-and-bill reimbursement model is familiar to ophthalmic practices and aligns with existing coverage and reimbursement policies. We believe this presents an opportunity for providers and facilities, including ASCs, where approximately 90% of cataract surgeries in the United States are performed 18 , to recognize incremental revenue from cataract surgeries. Our team has deep experience navigating this reimbursement landscape, particularly in ophthalmology and the medical retina space, to build reimbursement confidence among surgeons, administrators, and payors. We estimate that a limited number of cataract surgeons and ASCs perform the majority of cataract surgery procedures in the United States each year, with the top 5% of surgeons performing over 25% of the procedures 19 . We believe this concentrated market will enable us to build an efficient field-based sales force that can quickly unlock a significant portion of the market opportunity. Taken together, our commercial go-to-market strategy is designed to minimize friction and accelerate adoption in a well-understood and high-volume surgical setting with a right-sized field force footprint. 18 MarketScope Ophthalmic Market Trends Q2-2025 US Cataract Edition. 19 Schein OD, Cassard SD, Tielsch JM, Gower EW. Cataract surgery among Medicare beneficiaries. Ophthalmic Epidemiol. 2012 Oct;19(5):257-64 showing that the top 2,801 surgeons (less than 25%) performed 65.1% of the cataract surgeries in the United States billed through Medicare in 2003 to 2004. 21 Tab l e of Contents Manufacturing and Supply Chain We currently use contract manufacturing organizations (CMOs) to manufacture and supply the components of our drug delivery system, including the drug pads, IOL and injector system. All our CMOs, including analytical and distribution chain partners, maintain procedures for complying with current Good Manufacturing Practices (cGMP) requirements and have the capability and capacity to produce at both clinical-stage and commercial-stage scale. Drug Pads. A CMO sources materials used in our drug pads from outside vendors and formulates the pads in accordance with our proprietary manufacturing process. We have a nonexclusive arrangement with this CMO and can transfer the technology to another site as needed. IOL. Clinical and commercial supply agreements for our proprietary IOL have been secured with our IOL supplier to meet our planned clinical and commercial requirements through our first year of commercialization. Our IOL is manufactured to our specifications by an ISO13485-certified and FDA-registered CMO pursuant to a supply agreement with a two-year notice of termination. Our supply agreement currently excludes the right to conduct clinical trials or commercialize products using these IOLs in the People’s Republic of China, but will expand to include the People’s Republic of China if and when our CMO acquires such rights. We have granted a right of first negotiation to an affiliate of this CMO to become an exclusive distributor of our potential commercial product in Asia, Europe, the Middle East and Africa. This right terminates upon termination of the supply agreement. Injector. Our BIM-IOL System is designed to be compatible with a number of off-the-shelf injectors from various manufacturers. We have a supply agreement with an injector manufacturer to distribute its injector globally for use with the BIM-IOL System. We may seek similar agreements with other injector manufacturers. We have evaluated the performance of our product candidate with these injectors, which have been previously registered with regulatory authorities globally for use with commercial IOLs. Competition The biotechnology, pharmaceutical, medical technology and ophthalmology industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on IP. We believe our differentiated technology and approach, systems, robust IP portfolio, focused business strategy, and experienced leadership team position us competitively within this dynamic landscape. However, we face competition from many different sources, including large and specialty pharmaceutical, biotechnology, medical technology and ophthalmology companies, academic research institutions and governmental agencies, and public and private research institutions. Any product candidate we develop and commercialize will have to compete with existing therapies, devices and procedures as well as therapies, devices and procedures currently in development and that may be developed in the future. We believe that the key competitive factors affecting the success of any of our product candidates will include efficacy, safety, speed to market, ease of use and reliability, acceptance by physicians, reimbursement and costs, level of devoted promotional activity and IP protection. Our lead product candidate, the BIM-IOL System, is designed to treat OAG and OHT, placing us in direct competition with a range of therapies, devices, procedures and technologies, including topical eye drops, laser-based interventions, MIGS, and intracameral implants. These modalities are offered by companies with significant market presence and resources. For example, we compete with alternative glaucoma surgical device and ophthalmic laser companies such as Alcon, Allergan (AbbVie), Bausch & Lomb, Glaukos, and Johnson & Johnson, as well as pharmaceutical competitors such as Alcon, Allergan (AbbVie), Astellas, Genentech (Roche) and Regeneron. Many of our current or potential competitors, either alone or with their collaboration partners, have substantially greater financial resources and may have greater expertise in research and development, manufacturing, preclinical testing, conducting clinical trials and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical, biotechnology and ophthalmology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be strong competitors, particularly through collaborative arrangements with large and established companies. These companies also compete with us in recruiting and retaining qualified scientific and management personnel, as well as in acquiring technologies and IP complementary to, or necessary for, our product candidates. Because of the size of the ophthalmology and vision correction markets and the high growth profile of such markets, we anticipate that companies will dedicate substantial resources to developing competing products. We believe the benefits of our approach present a number of benefits, including: n long-term drug delivery that may improve outcomes; n ultralow dose and potential to improve quality of life; 22 Tab l e of Contents n seamless integration into existing surgical workflow; n confidence with established reimbursement pathways; n patient care with attractive facility economics; and n scalability and durability. See the sections titled “—Our Solution – The SpyGlass Platform” and “—Our Technology and Approach” for a detailed description of our potential competitive advantages. We expect that competing treatment options that are successfully developed could eventually be available both within and outside the United States. Our commercial opportunity could be impacted if competitors develop treatments and therapies that are more effective, safer, easier to use, or less costly—or if they achieve regulatory approval ahead of us. Intellectual Property Intellectual property, including patents, trade secrets, trademarks and copyrights, is important to our business. Our commercial success depends in part on our ability to obtain and maintain our intellectual property protections for our current products as well as for future product candidates and novel discoveries, product development technologies, and know-how. Our commercial success also depends in part on our ability to operate without infringing on the protected proprietary rights of others and to prevent others from infringing our protected proprietary rights. We seek to maintain our proprietary positions by, among other processes, filing U.S. and foreign patent applications to obtain patents that cover our products, product candidates, technology, inventions, and improvements thereof that are important to the development, protection and implementation of our business. All patents and patent applications in our intellectual property portfolio are co-owned with a single co-Applicant, the Regents of the University of Colorado, a body corporate (CU). We exclusively license the co-Applicant’s rights in these patents and patent applications that are co-owned. We may also license from third parties additional patent rights and proprietary know-how that we believe to be necessary or useful to our business. Additionally, we protect our proprietary know-how that may not be patentable or that is otherwise considered better for our business to maintain as a Company secret, and other confidential information, by maintaining and implementing policies and procedures for ensuring secrecy and confidentiality are maintained. We are currently seeking and maintaining patent protection in the United States and key foreign jurisdictions where we intend to market our products, and our future product candidates. Our patent portfolio includes a combination of patents and pending patent applications co-owned by and exclusively licensed to us. As of December 31, 2025, our co-owned and exclusively licensed patent estate contains eight (8) patent families comprising fifteen (15) issued U.S. patents, eleven (11) issued patents in Australia, China, Europe (including national validations in France, Germany, Italy, Spain and the United Kingdom), Japan and the United Kingdom, ten (10) pending U.S. non-provisional patent applications, and thirty-one (31) pending patent applications in various jurisdictions outside of the U.S., including Australia, Canada, Europe, Canada and Japan, and one (1) pending Patent Cooperation Treaty (PCT) application that has not yet entered national stage filing. The fifteen (15) issued U.S. patents are projected to expire between 2039 and 2043, before accounting for potentially available patent term adjustments or patent term extension, as appropriate, and assuming timely payment of appropriate maintenance, renewal, annuity and other governmental fees. Any patent that may issue from the current ten (10) pending U.S. patent applications is expected to expire between 2039 and 2043, without accounting for potentially available patent term adjustments or patent term extension, as appropriate, term-limiting effects of terminal disclaimers and assuming payment of appropriate maintenance, renewal, annuity and other governmental fees. The eleven (11) issued foreign patents are expected to expire between 2039 and 2040, without accounting for potentially available patent term extensions or patent term extension, as appropriate, and assuming payment of appropriate maintenance, renewal, annuity and other governmental fees. The thirty-one (31) pending foreign patent applications are expected to expire between 2039 and 2043, without accounting for potentially available patent term extensions and assuming payment of appropriate maintenance, renewal, annuity and other governmental fees. Our co-owned and exclusively licensed U.S. and foreign patents and patent applications generally relate to ophthalmic drug delivery systems, ophthalmic drug delivery components, devices, kits, manufacturing, and methods of use thereof. Our twenty-six (26) co-owned and exclusively licensed U.S. and foreign patents are set forth in the table below, which we believe cover portions of our relevant product and future products in development and technologies, including features and components of implantable intraocular structures and drug delivery products, their manufacturing and 23 Tab l e of Contents construction, their assembly and systems facilitating their assembly, and medical uses of the products and systems to treat health conditions such as eye-related disorders. The term of individual patents in our portfolio depends upon the legal term of patents in the countries in which they are obtained. In most countries in which we file, including the United States, the patent term is 20 years from the earliest date of filing a non-provisional patent application. In the United States, the term of a patent may be reduced due to filing of a terminal disclaimer made to overcome a double patenting rejection to a related/commonly owned patent, or may be lengthened by patent term adjustment to a patent, which permits patent term restoration in terms of added days to the life of a patent as compensation for delays incurred by the USPTO process during patent prosecution. Patent positions of companies like ours are generally uncertain and involve complex legal, procedural and factual questions. The relevant patent laws and changes to these laws and their interpretation inside the United States are uncertain. The relevant patent laws and their interpretation outside of the United States are also uncertain. Changes in either the patent laws or their interpretation in the United States and other countries may diminish our ability to protect our technology or product candidates and could affect the value of such intellectual property. In particular, our ability to stop third parties from making, using, selling, offering to sell or importing products that infringe our patents will depend in part on our success in obtaining, maintaining and enforcing patent claims that cover our technology, inventions and improvements. We cannot guarantee that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications we may file in the future, nor can we be sure that any patents that may be granted to us in the future will be commercially useful in protecting our products, the methods of use or manufacture of these products. Moreover, patents do not guarantee the right to practice our technology in relation to the commercialization of our products. Patents only allow us to attempt to prevent potential competitors from patenting our same inventions and/or practicing the claimed inventions of the patents specifically in the countries in which such patents are issued. Further, patents and other intellectual property rights in the drug delivery and medical device space are evolving and involve many risks and uncertainties. For example, third parties may have blocking patents that could be used to prevent us from patenting and/or commercializing our product candidates and practicing our proprietary technology. Our patents may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from making and/or marketing related products or could limit the term of patent protection that otherwise may exist for our product candidate and future product candidates. In addition, the scope of the rights granted under any patent may not provide us with protection or competitive advantages against competitors with similar technology. Furthermore, our competitors may independently develop similar technologies that are outside the scope of the rights granted under our patents. For these reasons, we may face competition with respect to our product candidates. Moreover, because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before any particular product candidate can be commercialized, any patent protection for such product may expire or remain in force for only a short period following commercialization, thereby reducing the commercial advantage the patent provides. In addition to patent protection, we rely on trade secret protection and know-how to expand our proprietary position around our chemistries, manufacturing, technologies and other discoveries and inventions that we consider important to our business. As of December 31, 2025, we have one (1) registered trademark in the United States and one registered trademark in each of Brazil, Canada, China, the European Union, United Kingdom, and South Korea, one (1) accepted trademark in the United States and eight (8) pending trademark applications in the United States and six (6) pending trademark applications filed via the Madrid Protocol. We also seek to protect our intellectual property in part by entering into confidentiality agreements with companies with whom we share proprietary and confidential information in the course of business discussions. We also have confidentiality terms and intellectual property assignment clauses in our agreements with our employees, consultants, scientific advisors, clinical investigators, work-for-hire contracts and other contractors. These agreements provide that all confidential information and potential intellectual property developed, discovered, or made known to the individual or the contractor during the course of the individual’s or contractor’s relationship with us is owned by us and to be disclosed to us and to be kept confidential and not disclosed to third parties except in specific circumstances. There can be no assurance, however, that these agreements will provide meaningful protection or adequate remedies for our trade secrets in the event of unauthorized use or disclosure of such information. We require our employees, commercial contractors, and certain consultants, externally hired contract engineers and investigators, to enter into intellectual property assignment agreements that assign us ownership of any discoveries or inventions made by them while under 24 Tab l e of Contents employment or working under contract on behalf of us. See the section titled “Risk Factors—Risks Related to Our Intellectual Property” for a more comprehensive description of risks related to our intellectual property. Exclusive License Agreement with the Regents of the University of Colorado In March 2020, we entered into an Exclusive License Agreement with the Regents of the University of Colorado (CU), which was amended in December of 2020, May of 2023 and October of 2025 (the License Agreement), pursuant to which CU granted us an exclusive, worldwide, royalty-bearing, transferable license, with the right to grant sublicenses, under certain patents and patent applications co-owned by CU and us relating to an intraocular drug dispenser (the Licensed Patents) for us to make, have made, use, import, offer to sell, sell, render and practice all products covered by the Licensed Patents (the License and such products the Licensed Products) in all fields. All Licensed Patents are jointly owned by CU and us. CU retains the non-exclusive right for itself and all other not-for-profit academic and research institutions to practice all Licensed Products for educational, research, clinical, or other non-commercial purposes. The U.S. federal government retains a non-exclusive right to practice the Licensed Patents under 35 U.S.C. §§ 200-212 and 37 C.F.R. § 401, and we must use commercially reasonable efforts to cause any Licensed Products to be manufactured substantially in the United States to the extent required by 35 U.S.C. § 204. Under the License Agreement, we are obligated to use commercially reasonable efforts to develop, market and sell at least two Licensed Products in all fields worldwide and to meet certain diligence milestones by certain deadlines. If we are, or a third party designee is, unable or unwilling to serve or develop a commercially reasonable potential market or market territory for which there is a reputable company with adequate resources to do and who is willing to be a sublicensee under the License Agreement, upon CU’s request, we are obligated to negotiate in good faith a sublicense with such company. In consideration of the rights granted by the License Agreement, we issued CU shares of our common stock and agreed to pay CU an annual license fee of up to $50,000. We are also required to pay CU certain contingent milestone payments of up to $1.05 million for each of the first two Licensed Products that achieve certain development and commercialization milestones. We agreed to pay CU royalties in the low single digit percentage of net sales of Licensed Products, subject to customary reductions. These royalties commence on the first commercial sale of such Licensed Product covered by a Valid Claim of a Licensed Patent in a country of such sale and continue until the expiration of the last valid claims under the Licensed Patents covering such Licensed Product in such country. We are also required to pay CU a percentage in the mid-twenties of consideration that we receive for sublicenses of, or options to sublicense, the Licensed Patents. We also agreed to reimburse CU for patent prosecution and maintenance expenses incurred by CU with respect to the Licensed Patents both prior to entering into the License Agreement, as well as any patent prosecution and maintenance expenses incurred by CU after entering into the License Agreement for the Licensed Patents. We have the first right to prosecute and maintain the Licensed Patents. If in the professional opinion of CU’s patent counsel or due to our negligence or misconduct in prosecuting the Licensed Patents, CU’s interest in the Licensed Patents is materially endangered, then CU may assume control of the prosecution and maintenance of any patent applications or patents included in the Licensed Patents if we fail to cure such negligence or misconduct within a designated time to cure. We have the first right to enforce the Licensed Patents against third party infringers. If we provide written notice to CU of our intention to not continue the prosecution or maintenance of the Licensed Patents or if we do not initiate suits to enforce the Licensed Patents, CU may step in to assume such prosecution, maintenance or enforcement of the Licensed Patents, respectively. The term of the License Agreement will expire upon the last to expire or last to be abandoned Valid Claim of a Licensed Patent, unless the License Agreement is terminated earlier in accordance with the terms therein. We may terminate the License Agreement in its entirety at any time upon prior written notice, and CU may terminate the agreement for our uncured material breach, our patent challenge to the Licensed Patents, insolvency, failure to use commercially reasonable efforts to develop a product covered by the Licensed Patents in the US, UK, France, Germany, Italy, Spain, Japan Canada and Australia, including efforts to meet the development and commercial milestones and obligations in the License Agreement, and cessation of sales of a commercially sold Licensed Product for two consecutive calendar quarters (unless it is commercially reasonable to discontinue such sales). If the License Agreement is terminated early, at CU’s request, we must provide CU with a copy of all data, documents and other materials filed by us or on our behalf with any U.S. or foreign agency pertaining to the Licensed Patents or necessary to manufacture or commercialize the Licensed Products. Government Regulation The FDA and other regulatory authorities at foreign federal, state and local jurisdictions impose extensive requirements upon the research clinical development, testing, manufacturing, labeling, quality controls, safety, efficacy, storage, 25 Tab l e of Contents recordkeeping, distribution, marketing, advertising, promotion, post-approval monitoring, AE reporting, and pricing of pharmaceutical and medical device products. Failure to comply with applicable regulatory requirements may result in warning letters, fines, civil or criminal penalties, suspension or delays in clinical development, recall or seizure of products, partial or total suspension of production or withdrawal of a product from the market. Drug Approval in the United States In the United States, the FDA regulates drug and device products, including combination products, under the Federal Food, Drug, and Cosmetic Act (FDCA), and its implementing regulations. Combination products where the drug is intended to provide the primary mechanism of action, such as those we intend to develop, are often referred to as “drug-led combination” products. The process required by the FDA before drug product candidates, including drug-led combination products, may be marketed in the United States generally involves the following: n completion of extensive preclinical laboratory tests and animal studies, with certain studies performed in accordance with the FDA’s Good Laboratory Practice (GLP) and other applicable regulations; n submission to the FDA of an IND which must become effective before human clinical trials may begin and must be updated periodically throughout clinical development; n approval by an independent institutional review board (IRB) or ethics committee at each clinical site before each trial may be initiated; n performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practice regulations (GCPs) to evaluate the safety and efficacy of the product candidate for each proposed indication; n submission to the FDA of a NDA after completion of all registrational or pivotal clinical trials; n a determination by the FDA within 60 days of its receipt of an NDA to file the application for review; n satisfactory completion of an FDA advisory committee review, if applicable; n satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the product is produced and tested to assess compliance with current Good Manufacturing Practice (cGMP) regulations to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; n satisfactory completion of potential inspection of selected clinical investigation sites to assess compliance with GCPs; and n FDA review and approval of an NDA prior to any commercial marketing or sale of the drug in the United States. Once a product candidate is identified for development, it enters the preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. The results of preclinical tests (which include laboratory evaluation as well as GLP studies to evaluate toxicity in animals) for a particular product candidate, together with related manufacturing information and analytical data, are submitted as part of an IND to the FDA. An IND is a request for allowance from the FDA to administer an investigational product to humans. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the proposed clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. The FDA may issue a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical trials involve the administration of the investigational product to human subjects, and must be conducted under the supervision of one or more qualified investigators in accordance with GCPs, which include, among other things, the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials must be conducted under protocols detailing, among other things, the objectives of the trial, dosing procedures, subject selection and exclusion criteria and the safety and effectiveness criteria to be evaluated. With each successive clinical trial conducted during product development and amendments to the study protocol, the sponsor must submit the study protocol and/or amendments to an existing IND. While the IND is active, progress reports summarizing the results of the clinical trials and preclinical studies performed since the last progress report, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected AE, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure. The sponsor also must notify the FDA 26 Tab l e of Contents of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information. Further, an independent IRB must review and approve the study protocol and subject recruitment materials for any clinical trial before the trial may begin. The FDA, the IRB or the sponsor may suspend a clinical trial at any time for various reasons, including a finding that the trial participants are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive GCPs, including regulations regarding informed consent and data privacy requirements with respect to health information and other individually identifiable information that may be collected during the trials. Clinical Trials For purposes of NDA submission and approval, clinical trials are typically conducted in the following sequential phases, which may overlap or be combined: n Phase 1 Clinical Trials. Trials are initially conducted in a limited population to test the product candidate for safety, dose tolerance, absorption, distribution, metabolism and excretion, typically in healthy humans, but in some cases in patients. n Phase 2 Clinical Trials. Trials are generally conducted in a limited patient population with a specified disease or condition to identify possible adverse effects and safety risks, explore the preliminary efficacy of the product candidate for specific targeted indications and to determine dose range and tolerance. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase 3 clinical trials. n Phase 3 Clinical Trials. These are commonly referred to as pivotal or registrational trials. Phase 3 clinical trials are undertaken in large patient populations to further evaluate dosage, provide substantial evidence of clinical efficacy and further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial centers. These clinical trials are intended to establish the overall risk-benefit ratio of the product candidate and provide an adequate basis for product labeling. Post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial regulatory approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA. Concurrent with clinical trials, companies often complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the product candidate and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final product. In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life. New Drug Applications (NDAs) The results of drug development, preclinical studies and clinical trials are submitted to the FDA as part of an NDA. NDAs also must contain extensive chemistry, manufacturing and control information. An NDA must be accompanied by a significant user fee, which may be waived in certain circumstances. The FDA conducts a preliminary review of an NDA within the first 60 days after submission, before accepting the application for filing, to determine whether it is sufficiently complete to permit substantive review. The FDA may refuse to file any NDA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the NDA must be resubmitted with the additional information before FDA will review the application. Once the submission has been accepted for filing, the FDA’s goal is to review applications within ten months of the filing date, or if the submission qualifies for priority review, six months from the filing. The review process may also be extended for a three-month period for FDA to review additional information deemed a “major amendment” to the application. During the review process, the FDA may refer the application to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it considers such recommendations carefully when making decisions. Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will generally inspect the facility or the facilities at which the drug is manufactured. The FDA will 27 Tab l e of Contents not approve the product candidate unless compliance with cGMP is satisfactory, and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied. After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter (CRL). A CRL generally outlines the deficiencies in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application when resubmitted. If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. Adequately responding to a CRL may require the sponsor to provide additional clinical data, including from additional clinical trials, and/or may include other significant, expensive and time-consuming requirements related to clinical trials, preclinical studies or manufacturing. In addition, the Pediatric Research Equity Act (PREA) requires a sponsor to conduct pediatric clinical trials for most drugs, for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration. Under PREA, original NDAs and certain supplements must contain a pediatric assessment unless the sponsor has received a deferral or waiver. The required assessment must evaluate the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and support dosing and administration for each pediatric subpopulation for which the product is deemed safe and effective. The sponsor may request or FDA may grant a deferral of pediatric clinical trials for some or all of the pediatric subpopulations. A deferral may be granted for several reasons, including a finding that the drug is ready for approval for use in adults before pediatric clinical trials are complete or that additional data need to be collected before the pediatric clinical trials begin. An approval letter authorizes commercial marketing of the drug product with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a REMS to help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use. The requirement for a REMS can materially affect the potential market and profitability of the drug. Moreover, the FDA may require substantial post-approval testing and surveillance, such as Phase 4 clinical trials, to monitor the drug’s safety or efficacy following approval. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified during commercialization. Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs. The NDA review process for drug-led combination includes a review of the device component. Expedited Review Programs The FDA has a number of programs intended to expedite the development or review of a marketing application for an investigational drug product. For example, the fast track designation program is intended to expedite the process for developing and reviewing product candidates that meet certain criteria, including that the product candidate be intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. The sponsor of a fast track product candidate has more opportunities to interact with the applicable FDA review team during product development and, once a marketing application is submitted, the application may be eligible for priority review. With regard to a fast track product candidate, the FDA may initiate the review of sections of the application on a rolling basis before a complete application is submitted. In such case, the sponsor pays the required user fees upon submission of the first section of the marketing application. A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy designation to expedite its development and review. A product candidate can receive breakthrough therapy designation if preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other therapeutics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product candidate. Any product candidate submitted to the FDA for approval, including a product candidate with a fast track designation or breakthrough designation, may also be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. An NDA is eligible for priority review if the product candidate is designed to treat a serious condition, and if approved, would provide a significant improvement in safety or efficacy compared to available therapies. The FDA will attempt to direct additional resources to the evaluation of an 28 Tab l e of Contents NDA designated for priority review in an effort to facilitate the review. The FDA endeavors to review applications with priority review designations within six months of the filing date instead of ten months for review of original NDAs under its current PDUFA review goals. A product candidate intended to treat serious or life-threatening diseases or conditions may be eligible for accelerated approval upon a determination that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA generally requires that the sponsor receiving accelerated approval perform adequate and well-controlled confirmatory clinical trials, and may require that such confirmatory trials be underway prior to granting accelerated approval. Products receiving accelerated approval may be subject to withdrawal if the sponsor fails to conduct the required confirmatory trials in a timely manner or if such trials fail to verify the predicted clinical benefit. In addition, the FDA requires as a condition of accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product. Fast track designation, breakthrough therapy designation, priority review, and accelerated approval do not change the standards for approval, but may expedite the development or approval process. Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. Post-Approval Requirements Drugs, including drug-device combination products, manufactured and distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing, annual program fees for any marketed products. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP requirements, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. Manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance. Once an approval is granted, the FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including AEs of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of requirements for post-market studies or clinical studies to assess new safety risks, or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things: n restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; n fines, warning letters, or untitled letters; n clinical holds on ongoing or planned clinical studies; n refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of approvals; n product seizure or detention, or refusal to permit the import or export of products; n consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; n mandated modification of promotional materials and labeling and the issuance of corrective information; n issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or n injunctions or the imposition of civil or criminal penalties. 29 Tab l e of Contents The FDA closely regulates the marketing, labeling, advertising, and promotion of drug products. A company can make only those claims relating to safety and efficacy that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising, and potential civil and criminal penalties. Physicians may prescribe, in their independent professional medical judgment, legally available products for uses that are not described in the product’s labeling and that differ from those tested by the product sponsor and approved by the FDA. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA, however, restricts manufacturer’s communications on the subject of off-label use of their products. The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined companies from engaging in off-label promotion. The FDA and other regulatory agencies have also required that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. However, companies may share truthful and not misleading information that is otherwise consistent with a product’s FDA-approved labelling. In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (PDMA), which regulates the distribution of drugs and drug samples at the federal level and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution. Combination Products Certain of our product candidates, including the BIM-IOL System, are comprised of components, such as drug components and device components, that would normally be subject to different regulatory frameworks by the FDA and regulated by different centers at the FDA. These products are known as combination products. Under the FDCA and its implementing regulations, the FDA is charged with assigning a center with primary jurisdiction, or a lead center, for review of a combination product. The designation of a lead center generally eliminates the need to receive approvals from more than one FDA center for combination products, although it does not preclude consultations by the lead center with another FDA center. The determination of which center will be the lead center is based on the “primary mode of action” of the combination product. The FDA has established an Office of Combination Products to address issues regarding combination products and provide more certainty to the regulatory review process. This office is responsible for developing guidance and regulations to clarify the regulation of combination products, and for assigning the FDA center that will have primary jurisdiction for review of a combination product where the jurisdiction is unclear or in dispute. Following approval of a combination product, each component of a combination product retains its regulatory status (as a drug or device, for example) and is subject to the requirements established by the FDA for that type of component. A combination product candidate with a drug primary mode of action, as we believe our combination products to be regulated, generally would be reviewed and approved pursuant to an NDA. In reviewing the NDA for such a product, however, FDA reviewers at the Center for Drug Evaluation and Research (CDER) could consult with their counterparts at the Center for Devices and Radiological Health (CDRH) to ensure that the drug and device components of the combination product candidate, as applicable, met all requirements applicable to its category. In addition, under FDA regulations, combination products are subject to the cGMP requirements applicable to each component within the combination, including the Quality System Regulation (QSR) applicable to medical devices. Hatch-Waxman Amendments Section 505 of the FDCA describes three types of marketing applications that may be submitted to the FDA to request marketing authorization for a drug product. A Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and efficacy. A 505(b)(2) NDA is an application that contains full reports of investigations of safety and efficacy but where at least some of the information required for approval comes from investigations that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. This regulatory pathway enables the applicant to rely, in part, on the FDA’s prior findings of safety and efficacy for an existing product, or published literature, in support of its application. Section 505(j) establishes an abbreviated approval process for a generic version of approved drug products through the submission of an Abbreviated New Drug Application (ANDA). An ANDA provides for marketing of a generic drug product that has the same active ingredients, dosage form, strength, route of administration, labeling, performance characteristics and intended use, among other things, to a previously approved product, known as a reference listed drug (RLD). ANDAs are termed “abbreviated” because they are generally not required to include preclinical (animal) 30 Tab l e of Contents and clinical (human) data to establish safety and efficacy. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent to, or performs in the same manner as, the RLD through in vitro , in vivo , or other testing. The generic version must deliver the same amount of active ingredient(s) into a subject’s bloodstream in the same amount of time as the RLD, and pursuant to state law, a generic product can often be substituted by pharmacists under prescriptions written for the RLD. FDA Regulatory Exclusivity Market exclusivity provisions authorized under the FDCA can delay the submission and approval of certain marketing applications for products containing the same active ingredient. The FDCA permits patent term restoration of up to five years as compensation for a patent term lost during product development and FDA regulatory review process to the first applicant to obtain approval of an NDA for a new chemical entity (NCE) in the United States. Patent-term restoration, however, cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The Hatch-Waxman Amendments established a period of five years of non-patent data exclusivity for a new drug containing an NCE. For the purposes of this provision, a drug is considered to be an NCE if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the physiological or pharmacological action of the drug substance. If granted, the NCE exclusivity provides that an ANDA may not be filed with the FDA until the expiration of five years after approval of the RLD, unless the submission is accompanied by a Paragraph IV certification, which states the proposed generic drug will not infringe one or more of the already approved product’s listed patents or that such patents are invalid or unenforceable, in which case the applicant may submit its application four years following the RLD’s approval. The FDCA also provides for a period of three years of non-patent exclusivity for non-NCE drugs if the NDA or NDA supplement includes reports of one or more new clinical investigations, other than bioavailability or bioequivalence studies, that were conducted by or for the applicant and are essential to the approval of the application or supplement. This three-year exclusivity period often protects changes to a previously approved drug product, such as a new dosage form, route of administration, combination or indication, but it generally would not protect the originally approved product from generic competition. Unlike five-year NCE exclusivity, the three-year new clinical investigation exclusivity does not block the FDA from accepting ANDA or 505(b)(2) applications but prevents FDA from approving them. A drug product can obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods for all formulations, dosage forms, and indications of the active moiety and to patent terms. The six-month exclusivity, which runs from the end of existing regulatory exclusivity period and patent terms, may be granted based on the voluntary completion of a pediatric study that fairly responds to an FDA-issued “Written Request” for such a study, except that the pediatric exclusivity cannot be applied to any patent or exclusivity period that expires within nine months of the grant of pediatric exclusivity. Hatch-Waxman Patent Certification and the 30-Month Stay In seeking approval of an NDA or a supplement thereto, NDA sponsors are required to list with the FDA each patent with claims that cover the applicant’s product or an approved method of using the product. Upon approval, each of the patents listed by the NDA sponsor is published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Upon submission of an ANDA or 505(b)(2) NDA, an applicant is required to certify to the FDA concerning any patents listed for the RLD in the Orange Book that: n no patent information on the drug product that is the subject of the application has been submitted to the FDA; n such patent has expired; n the date on which such patent expires; or n such patent is invalid, unenforceable or will not be infringed upon by the manufacture, use, or sale of the drug product for which the application is submitted. Generally, the ANDA or 505(b)(2) NDA cannot be approved until all listed patents have expired, except where the ANDA or 505(b)(2) NDA applicant challenges a listed patent through the last type of certification, also known as a paragraph IV certification. If the applicant does not challenge the listed patents or indicates that it is not seeking approval of a patented method of use, the ANDA or 505(b)(2) NDA application will not be approved until all of the listed patents claiming the referenced product have expired. If the ANDA or 505(b)(2) NDA applicant has provided a paragraph IV certification the applicant must send notice of the paragraph IV certification to the NDA and patent holders once the application has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the paragraph IV certification. If the paragraph IV certification 31 Tab l e of Contents is challenged by an NDA holder or the patent owner(s) asserts a patent challenge to the paragraph IV certification, the FDA may not approve that application until the earlier of 30 months from the receipt of the notice of the paragraph IV certification, the expiration of the patent, when the infringement case concerning each such patent was favorably decided in the applicant’s favor or settled, or such shorter or longer period as may be ordered by a court. This prohibition is generally referred to as the 30-month stay. In instances where an ANDA or 505(b)(2) NDA applicant files a paragraph IV certification, the NDA holder or patent owner(s) regularly take action to trigger the 30-month stay, recognizing that the related patent litigation may take many months or years to resolve. Thus, approval of an ANDA or 505(b)(2) NDA could be delayed for a significant period of time depending on the patent certification the applicant makes and the RLD sponsor’s decision to initiate patent litigation. FDA Medical Device Regulation Unless otherwise specified by the FDA, under the FDCA, medical devices are classified into one of three classes-Class I, Class II or Class III-depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurances with respect to safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be reasonably assured by adherence to a set of FDA regulations, referred to as the General Controls for Medical Devices, which require compliance with the applicable portions of the QSR, which sets forth the FDA’s current good manufacturing practices for medical devices. On January 31, 2024, the FDA issued a final rule replacing the QSR with a new regulation referred to as the Quality Management System Regulation (QMSR), which incorporates by reference the standards set forth in ISO 13485:2016, though this final rule is not scheduled to go into effect until February 2026. Class I medical devices must also comply with requirements for facility registration and product listing, reporting of adverse medical events and malfunctions, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials. Most Class I products are exempt from the premarket notification requirements. Class II devices are those that are subject to the General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, patient registries, FDA guidance documents and post-market surveillance. Most Class II devices are subject to premarket review and clearance by the FDA. Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification process, in which the device manufacturer must demonstrate substantial equivalence to a previously cleared device, known as a predicate device. In certain cases, where no predicate device exists, Class II devices may come to market through the de novo classification process. Class III devices include devices deemed by the FDA to pose the greatest risk such as life-supporting or life-sustaining devices, implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device. The safety and effectiveness of Class III devices cannot be reasonably assured solely by the General Controls and Special Controls described above. Therefore, these devices are subject to the premarket approval (PMA) application process, which is generally more costly and time consuming than the 510(k) process. Through the PMA application process, the applicant must submit data and information demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use to the FDA’s satisfaction. Establishments that manufacture any class of device, including manufacturers, contract manufacturers, sterilizers, repackagers and relabelers, specification developers, reprocessors of single-use devices, remanufacturers, initial importers, and U.S. manufacturers of export-only devices, are required to register their establishments with the FDA and provide FDA a list of the devices that they handle at their facilities. While we have no current plans to seek premarket approval for any device products, our lead combination product candidate is subject to regulation by CDER and by CDRH, although CDER has primarily jurisdiction over the drug-led combination product. The device component of our combination product candidate must comply with the applicable medical device quality controls. Manufacturing processes for medical devices are required to comply with the applicable portions of the QSR, or QMSR, which include the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files, all of which will be incorporated with or coordinated with the cGMP requirements for the drug component of the combination product candidate. 32 Tab l e of Contents The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: n warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; n recalls, withdrawals, or administrative detention or product seizures; n operating restrictions or partial suspension or total shutdown of production; n refusing or delaying requests for marketing authorization of new products or modified products; n withdrawing marketing authorizations that have already been granted; n refusal to grant export approvals for; or n criminal prosecution. Other U.S. Healthcare Laws Pharmaceutical and device manufacturers are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business. Such laws include, without limitation, U.S. federal and state anti-kickback, fraud and abuse, false claims, pricing reporting, manufacturer and distributor license requirements, and physician payment transparency laws and regulations regarding drug pricing and payments or other transfers of value made to physicians and other licensed healthcare professionals as well as similar foreign laws in the jurisdictions outside the United States. The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid, or other federally financed healthcare programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers, among others, on the other. In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to commit a violation. Although there are a number of statutory exceptions and regulatory safe harbors protecting certain business activities from prosecution or other regulatory sanctions, the exceptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. Federal civil and criminal false claims laws, including the federal civil False Claims Act, prohibit any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to have a false claim paid. This includes claims made to programs where the federal government reimburses, such as Medicare and Medicaid, as well as programs where the federal government is a direct purchaser, such as when it purchases off the Federal Supply Schedule. Pharmaceutical and other healthcare companies have been prosecuted under these laws for, among other things, allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. In addition, certain marketing practices, including off-label promotion, may also violate false claims laws. Additionally, a violation the federal Anti-Kickback Statute can serve as a basis for liability under the federal False Claims Act. Most states also have statutes or regulations similar to the federal Anti-Kickback Statute and civil False Claims Act, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. Other federal statutes pertaining to healthcare fraud and abuse include the civil monetary penalties statute, which prohibits, among other things, the offer or payment of remuneration to a Medicaid or Medicare beneficiary that the offeror or payor knows or should know is likely to influence the beneficiary to order a receive a reimbursable item or service from a particular supplier, and the additional federal criminal statutes created by the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which prohibits, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program or obtain by means of false or fraudulent pretenses, representations or promises any money or property owned by or under the control of any healthcare benefit program in connection with the delivery of or payment for healthcare benefits, items or services. In addition, there has been increased federal and state regulation of payments made to physicians and other healthcare providers. The Physician Payments Sunshine Act imposes reporting requirements on certain drug and device manufacturers for payments made by them to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse 33 Tab l e of Contents specialists, certified registered nurse anesthetists, anesthesiology assistants, and certified nurse midwives) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Manufacturers must report such payments to the government by the 90th day of each calendar year. Violation of any of such laws or any other governmental regulations that apply may result in significant penalties, including, without limitation, administrative civil and criminal penalties, damages, disgorgement fines, additional reporting requirements and oversight obligations, contractual damages, the curtailment or restructuring of operations, exclusion from participation in governmental healthcare programs and/ or imprisonment. Data Privacy and Security Laws Numerous state, federal and foreign laws, regulations and standards govern the collection, use, access to, confidentiality and security of health-related and other personal information, and could apply now or in the future to our operations or the operations of our partners. In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information. For example, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their respective implementing regulations, impose obligations on certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as well as their business associates that perform certain services involving the storage, use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security, and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information. HITECH increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In addition, many state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, and often are not preempted by HIPAA. Further, certain foreign laws govern the privacy and security of personal data, including health-related data. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing. Coverage and Reimbursement Successful sales of any drug products, if approved, in the U.S. market, will depend, in part, on the extent to which the drugs are eligible for adequate reimbursement by third-party payors, such as government health programs, such as Medicare and Medicaid, and private health insurance (including managed care plans). Coverage and reimbursement policies for drug products can differ significantly from payor to payor as there is no uniform policy of coverage and reimbursement for drug products among third-party payors in the United States. Adequate coverage and reimbursement from third-party payors are critical to new and ongoing product acceptance. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow the manufacturer to establish or maintain pricing sufficient to realize a return. There may be significant delays in obtaining coverage and reimbursement as the process of determining coverage and reimbursement is often time consuming and costly. Further, third-party payors are increasingly reducing reimbursements for medical drugs and services and implementing measures to control utilization of drugs such as requiring prior authorization or step therapy for coverage, among other criteria. For products administered under the supervision of a physician or other healthcare professional, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the product itself or the treatment or procedure in which the product is used or delivered may not be available, which may impact physician utilization. There is also significant uncertainty related to the insurance coverage and reimbursement of newly approved products and coverage may be more limited than the purposes for which the medicine is approved by the FDA or comparable foreign regulatory authorities. In the United States, private payors tend to follow the coverage and reimbursement policies of CMS, the federal agency that administers the Medicare and Medicaid Programs, to a substantial degree. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by laws that permit importation of certain drugs from countries where they may be sold at lower prices than in the United States. Increasingly, third-party payors are requiring drug companies to provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that coverage will be available for any product candidate that we commercialize and, if available, the level of reimbursement. In addition, many pharmaceutical manufacturers must calculate and report certain pricing 34 Tab l e of Contents information to the government, such as average sales price and best price. Penalties may apply in some cases when the required information is not submitted accurately and timely. Further, these prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs. U.S. Healthcare Reform The U.S. government, state legislatures and foreign governments have shown significant interest in implementing measure to reduce the cost of healthcare, including drug pricing controls. Adoption of price controls and cost-containment measures could negatively impact our net revenue and results. Decreases in third-party payor reimbursement or a decision by a third-party payor to not cover a drug product could have a material adverse effect on sales and results of business operations. For example, in March 2010, the Affordable Care Act (ACA), was enacted in the United States and substantially changed the way healthcare is financed by both the government and private insurers. The ACA contains provisions that may reduce the profitability of drug products. Among other things, the ACA established an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs; extended manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; expanded eligibility criteria for Medicaid programs; expanded the entities eligible for discounts under the 340B drug pricing program; and increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program. Since its enactment, there have been executive, judicial and Congressional challenges to certain aspects of the ACA. In June 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA, which remains in effect in its current form. In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminated the statutory Medicaid drug rebate cap, for single source and innovator multiple source drugs, beginning January 1, 2024. The rebate was previously capped at 100% of a drug’s average manufacturer price. Additionally, there has been heightened governmental scrutiny in the United States of rising drug prices. Such scrutiny has resulted in several recent Congressional inquiries, presidential executive orders and proposed and enacted federal and state legislation and regulations designed to, among other things, reduce the cost of prescription drugs under Medicare, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. In August 2022, the Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, CMS selected 10 high-cost Medicare Part D drugs in 2023 and the negotiated maximum fair price for each drug has been announced. CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027. For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected. Various industry stakeholders, including pharmaceutical companies and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act are unconstitutional. Further, the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S. Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the United States. If HHS begins to set most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or increases generic and biosimilar drug entry sooner than expected, that can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future. Additionally, the One Big Beautiful Bill Act (OBBBA), which was signed into law in July 2025, includes provisions that will impact the U.S. healthcare system in various ways, including by cuts to Medicaid and introducing new participant work and eligibility requirements for Medicaid coverage, which are expected to significantly change the administration and applicability of Medicaid coverage. The OBBBA also expanded the orphan drug exemptions under the Medicare Price Negotiation Program, including an amendment to exclude orphan designated drugs for one or more 35 Tab l e of Contents rare diseases or conditions, instead of only one disease/condition, with the initial price applicability year 2028 and after, from Medicare price negotiations, and providing that the time for measuring a former orphan drug’s eligibility for Medicare price negotiations will be calculated from the first day after the date of FDA approval for a non-orphan disease or condition, or an approval for which the drug does not have orphan drug designation. The expansion of the exemptions for orphan designated drugs from the Medicare Drug Price Negotiation Program is expected to provide greater incentives for the development of drugs for orphan diseases and conditions. We cannot predict the full impact of the OBBBA, executive orders, and new laws focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the United States. The impact of ongoing and future judicial challenges as well as future legislative, executive, and administrative actions and any future healthcare measures and agency rules implemented by the current administration on us and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures, including the prescription drug provisions under the Inflation Reduction Act, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing. A number of states are considering or have recently enacted state drug price transparency and reporting laws that could substantially increase our compliance burdens and expose us to greater liability under such state laws once we begin commercialization after obtaining regulatory approval for any of our products. For example, the FDA has authorized the state of Florida to develop Section 804 Importation Programs to import certain prescription drugs from Canada for a limited period of time to help reduce drug costs, provided that Florida’s Agency for Health Care Administration meets the requirements set forth by the FDA. Other states may follow Florida. We are unable to predict the future course of federal or state healthcare measures in the United States directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. These and any further changes in the law or regulatory framework that reduce our revenue or increase our costs could also have a material and adverse effect on our business, financial condition and results of operations. Employees and Human Capital Resources As of December 31, 2025, we had 65 full-time employees, 57 of whom were engaged in research and development activities. We also engage contractors and consultants. None of our employees are represented by a labor union or covered under a collective bargaining agreement. We have not experienced any work stoppages due to employee disputes, and we consider our relationship with our employees to be good. Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants. The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel through the granting of stock-based and cash-based compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives. Corporate Information We were incorporated in Delaware in January 2019 under the name SpyGlass Ophthalmics, Inc., and we changed our name to SpyGlass Pharma, Inc. in March 2021. Our principal executive offices are located at 27061 Aliso Creek Rd., Suite 100, Aliso Viejo, California 92656. Our telephone number is (949) 284-6904. Our website is www.spyglasspharma.com . Information contained on, or that can be accessed through, our website is not a part of, and is not incorporated into, this Annual Report, and the inclusion of our website address in this Annual Report is an inactive textual reference only. Available Information Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, and all amendments to these filings, can be obtained free of charge from our website at www.spyglasspharma.com following our filing of any of these reports with the SEC. The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. The contents of these and other websites referenced throughout the filing are not incorporated and do not constitute a part of this filing. Further, the Company’s references to the URLs for these websites are intended to be inactive textual references only. 36 Tab l e of Contents We have used, and intend to continue to use, our investor relations website, press releases, public conference calls, and webcasts to disclose material non-public information and to comply with our disclosure obligations under Regulation FD. 37 Tab l e of Contents Item 1A. Risk Factors Investing in our common stock involves a high degree of risk. Before making an investment decision, you should carefully consider the risks and uncertainties described below, together with all of the other information in this Annual Report, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included elsewhere in this Annual Report. The risks and uncertainties described below are not the only ones we face. Our business, operating results, financial condition or prospects could also be harmed by risks and uncertainties not currently known to us or that we currently do not believe are material. If any of the risks actually occur, our business, operating results, financial condition and prospects could be adversely affected. In that event, the market price of our common stock could decline, and you could lose part or all of your investment. Our Risk Factors are not guarantees that no such conditions exist as of the date of this Annual Report and should not be interpreted as an affirmative statement that such risks or conditions have not materialized, in whole or in part. These disclosures reflect the Company’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities in the future. References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future. Risk Factors Summary The following risks and uncertainties are among the most significant we face. However, the risks and uncertainties identified in this subsection are not the only ones we face and are qualified in their entirety by reference to all of the risk factors described herein: Risks Related to Our Limited Operating History, Our Business and Our Industry n We are a late-stage biopharmaceutical company with a limited operating history in developing drug delivery systems and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability. n We have incurred significant losses and negative cash flows from operations since our formation, and we anticipate that we will continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability. n We are substantially dependent on the success of our lead product candidate, our BIM-IOL System, which is currently in clinical trials. If we are unable to complete development of, obtain approval for and commercialize our BIM-IOL System in a timely manner our business will be harmed. We currently generate no revenues from sales of any products and may never generate revenue or be profitable. n Even if the BIM-IOL System or any other product candidate receives marketing approval, such product candidate may fail to achieve market acceptance by surgeons, patients and others in the medical community, and the market opportunity for these product candidates, if approved, may be smaller than we estimate. n We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted. Our product candidates may, if approved, also face competition from existing branded, generic and off-label products. n We expect that we will need substantial additional capital to complete the development and any commercialization of our current and any future product candidates, which may cause dilution to our stockholders. If we are unable to raise this capital when needed, we may be forced to delay, reduce or eliminate our research and development programs or other operations. Risks Related to Our Intellectual Property n We depend substantially on intellectual property rights granted under our license agreement with the Regents of the University of Colorado. If we lose our existing license or are unable to acquire or license additional proprietary rights from third parties, we may not be able to continue developing our product candidates. n If we are unable to obtain and maintain sufficient intellectual property protection for our technology, products and product candidates we may develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully develop and, if approved, commercialize our products may be adversely affected. n The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our potential future collaborators will be successful in protecting our BIM-IOL System or our other product candidates by obtaining and defending patents. 38 Tab l e of Contents n We may become involved in third-party claims of intellectual property infringement, which may delay or prevent the development and commercialization of our BIM-IOL System and any future product candidate. Risks Related to Development, Regulatory Approval and Commercialization n The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to generate product revenue and our business will be substantially harmed. n The clinical trials of our product candidates may not demonstrate safety and efficacy to the satisfaction of the FDA or other comparable foreign regulatory authorities or otherwise produce positive results. n Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement policies, as well as pricing regulations. Risks Related to Our Business Operations n Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees. n We rely, and expect to continue to rely, on third parties, including independent clinical investigators and contract research organizations (CROs), to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed. n We have identified a material weakness in our internal control over financial reporting which, if not remediated, could cause us to fail to timely and accurately report our financial results or prevent fraud, result in restatements of our financial statements and could subject our stock to delisting. As a consequence, stockholders could lose confidence in our financial reporting and our stock price could suffer. Risks Related to Ownership of Our Common Stock n An active, liquid and orderly market for our common stock may not develop, or if it is developed, may not be sustained, or we may in the future fail to satisfy the continued listing requirements of Nasdaq, and, as a result, it may be difficult for you to sell your shares of our common stock. n The trading price of our common stock may be highly volatile, and you could lose all or part of your investment. n Our principal stockholders and management own a significant percentage of our common stock and will be able to exercise significant influence over matters subject to stockholder approval. Risks Related to Our Limited Operating History, Our Business and Our Industry We are a late-stage biopharmaceutical company with a limited operating history in developing drug delivery systems and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability. We are a late-stage biopharmaceutical company with a limited operating history. We have no products approved for commercial sale and have not generated any revenue from product sales. Since our inception, we have devoted substantially all of our resources to the research and development of our product candidates by conducting clinical trials and preclinical studies, building our novel drug delivery technology (SpyGlass Platform), and recruiting management and technical staff to support these operations. We have not yet demonstrated our ability to successfully obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history. In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by biopharmaceutical companies developing products in rapidly evolving fields. If any of our product candidates are approved by the U.S. Food and Drug Administration (FDA), we will need to expand our commercialization infrastructure to successfully launch such product and also may need to transition from a company with a research focus to a company capable of supporting commercial activities. If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer. 39 Tab l e of Contents We have incurred significant losses and negative cash flows from operations since our formation, and we anticipate that we will continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability. We do not have any products approved for sale, we have not generated any revenue from the sale of products, and we have incurred significant net losses since our company’s formation. We have funded our operations primarily from the sale and issuance of redeemable convertible preferred stock. Our net losses were $39.9 million and $29.2 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $104.7 million. Additionally, the net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indicator of our future performance. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. We expect to continue incurring significant expenses and increasing operating losses for the foreseeable future. We expect that our expenses will increase substantially if and as we: n initiate additional clinical and other studies for our product candidates; n change or add additional manufacturers or suppliers, some of which may require additional permits or other governmental approvals; n create additional infrastructure to support our operations as a public company and our product development and planned future commercialization efforts; n seek marketing approvals for our product candidates; n establish a sales, marketing, and distribution infrastructure to commercialize any product candidates for which we may obtain marketing approval; n seek to identify, acquire and develop additional product candidates; n acquire or in-license other product candidates and technologies; n make milestone or other payments in connection with the development or approval of our product candidates; n maintain, protect, and expand our intellectual property portfolio; and n experience any delays or encounter issues with any of the above. Our prior losses and expected future losses have had and will continue to have an adverse effect on our working capital and our ability to achieve and maintain profitability. In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by biopharmaceutical companies in rapidly evolving fields. We also may need to transition from a company with a research focus to a company capable of supporting commercial activities. If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer. We are substantially dependent on the success of our lead product candidate, our BIM-IOL System, which is currently in clinical trials. If we are unable to complete development of, obtain approval for and commercialize our BIM-IOL System in a timely manner our business will be harmed. We currently generate no revenues from sales of any products and may never generate revenue or be profitable. Our future success is dependent on our ability to timely complete clinical trials, obtain marketing approval for and successfully commercialize our lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), which is comprised of novel, proprietary non-bioerodible drug pads attached to our non-bioerodible intraocular lens (IOL), designed to release three years of bimatoprost, the active pharmaceutical ingredient (API) in a highly effective prostaglandin analog (PGA) that was approved by the FDA in 2001. The BIM-IOL System is designed to be implanted during routine cataract surgery to reduce elevated intraocular pressure (IOP) in patients undergoing cataract surgery who have either open-angle glaucoma (OAG) or ocular hypertension (OHT). We are investing significant efforts and financial resources in the research and development of the BIM-IOL System and the SpyGlass Platform generally. We are conducting a Phase 1/2 clinical trial and have initiated two registrational Phase 3 clinical trials. We expect to complete enrollment in 2027 and, pending successful Phase 3 results, we plan to submit a 505(b)(2) New Drug Application (NDA) to the FDA in 2028 to seek approval of the BIM-IOL System. We have no products approved for commercial sale and do not anticipate generating any revenue unless our BIM-IOL System or one of our other product candidates receives the regulatory approvals necessary for commercialization. Our ability to generate revenues from product sales will depend on our obtaining marketing approval for and commercializing any such approved product, and we cannot accurately predict when or if our BIM-IOL System or any of our other product candidates will be found 40 Tab l e of Contents safe and effective in humans for our proposed indications or whether our BIM-IOL System or any other such product candidates will receive marketing approval in any jurisdiction. We are not permitted to market or promote any product candidate before we receive marketing approval from the FDA and comparable foreign regulatory authorities, as applicable, and we may never receive such marketing approvals. Our ability to generate revenue and achieve profitability, which we do not expect will occur for many years, if ever, depends significantly on the successful development and eventual commercialization of our product candidates. The success of our product candidates will depend on several factors, including, but not limited to, the following: n successful and timely completion of clinical and preclinical development of our BIM-IOL System and any future product candidates; n the initiation and successful patient enrollment and completion of our planned and ongoing clinical trials, as well as any necessary additional clinical trials, in each case with favorable results and on a timely basis; n establishing and maintaining relationships with contract research organizations (CROs), and clinical sites for the clinical development, both in the United States and internationally, of our BIM-IOL System and any future product candidates; n the frequency and severity of adverse events (AEs) in clinical trials; n efficacy, safety and tolerability results that are satisfactory to the FDA or any comparable foreign regulatory authority for marketing approval; n timely receipt of marketing approvals from applicable regulatory authorities for any of our product candidates, including the BIM-IOL System or any future product candidates, for which we successfully complete clinical development; n completing any required post-marketing commitments or requirements agreed to with or required by applicable regulatory authorities; n developing an efficient and scalable manufacturing process, either directly or through a third party contract manufacturing organization (CMO), for our product candidates, including obtaining finished products that are appropriately packaged for sale; n establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet any potential market demand for product candidates that we develop, if approved; n our ability to locate and retain alternate suppliers for the various components of our product candidates on commercially reasonable terms; n successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators; n a continued acceptable safety profile following any marketing approval of our product candidates; n commercial acceptance of our product candidates by patients, physicians and surgeons, as well as the broader medical community, and government and third-party payors; n identifying, assessing and developing new product candidates; n obtaining, maintaining and expanding patent protection, trademark protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; n protecting our rights in our intellectual property portfolio; n defending against third-party interference or infringement claims, if any; n negotiating favorable terms in any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; n obtaining coverage and adequate reimbursement for physicians, hospitals and ambulatory surgery centers from government and third-party payors for product candidates that we develop; n addressing any competing therapies and technological and market developments; and n attracting, hiring and retaining qualified personnel. We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any future collaborator. We may never be successful in achieving our objectives and, 41 Tab l e of Contents even if we do, may never generate revenue that is significant or large enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable may decrease the value of our company and could impair our ability to maintain or further our research and development efforts, raise additional necessary capital, grow our business and continue our operations. We or our CMOs may also experience delays in developing a sustainable, reproducible and scalable manufacturing process, which may prevent us from completing our clinical trials or commercializing our product candidates on a timely or profitable basis, if at all. Certain changes in the manufacturing process or facilities we intend to utilize, directly or through a CMO, may require further comparability analysis and/or prior approval by the FDA before implementation, which could delay our clinical trials and product candidate development, and could require additional clinical trials, including bridging studies, to demonstrate comparability to materials produced using different processes or at other facilities. Even if the BIM-IOL System or any other product candidate receives marketing approval, such product candidate may fail to achieve market acceptance by surgeons, patients and others in the medical community, and the market opportunity for these product candidates, if approved, may be smaller than we estimate. If the BIM-IOL System or any other product candidate that we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by surgeons, patients, and others in the medical community. Our BIM-IOL System is designed to solve for the limitations presented by currently available therapies by empowering cataract surgeons to use our BIM-IOL System when performing routine cataract surgeries and is designed to fit into all cataract surgeons’ existing procedural flow and preferred techniques; however, cataract surgeons may not accept a new treatment option or feel uncomfortable using a new technology. As a result, even if the BIM-IOL System demonstrates promising or superior clinical results, it is possible that surgeons instead may continue to rely on existing medications, products or treatments. If the BIM-IOL System or any other product candidate that we develop does not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of the BIM-IOL System or any other product candidate that we develop, if approved, will depend on a number of factors, including: n surgeons, patients and others in the medical community considering our product candidates as safe and effective treatments, and their willingness to try or prescribe, as applicable, a new therapy; n our ability to offer our product candidates for sale at competitive prices, particularly if there are alternative treatments at a lower or equivalent cost, and the availability of coverage and adequate reimbursement by third-party payors, including government authorities; n the clinical indications for which the product is approved; n the potential and perceived advantages, and the relative convenience and ease of administration of our product candidates, including as compared to the existing standard of care, alternative treatments and competitive therapies; n the willingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement by third-party payors, including government authorities; n the strength of our marketing and distribution support; n the timing of market introduction of our product candidates as well as competitive products; n the potential for our competitors to limit our access to the market through anti-competitive contracts or other arrangements; n the prevalence and severity of any side effects; and n any restrictions on the use of our product candidates together with other medications. Furthermore, our assessment of the potential market opportunity for the BIM-IOL System is based on industry and market data that we obtained from industry publications and research, surveys, and studies conducted by third parties, as well as management’s knowledge and experience in our industry. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our estimates of the potential market opportunities for our product candidates include several key assumptions based on our industry knowledge, the wholesale acquisition cost of iDose TR, industry publications, third-party research and other surveys, which may be 42 Tab l e of Contents based on a small sample size and/or fail to accurately reflect market opportunities. If any of our assumptions or estimates or any of these publications, research, surveys or studies prove to be inaccurate, then the actual market for the BIM-IOL System or any of our other product candidates may be smaller than we expect, which would have an adverse material impact on our business, financial condition and results of operations. We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted. Our product candidates may, if approved, also face competition from existing branded, generic and off-label products. The development and commercialization of new drug products is highly competitive. We face competition with respect to the BIM-IOL System and will face competition with respect to any other product candidates that we may seek to develop or commercialize in the future, from large and specialty pharmaceutical, biotechnology, medical technology and ophthalmology companies, academic research institutions and governmental agencies, and public and private research institutions. Any product candidate we develop and commercialize will have to compete with existing therapies, devices and procedures as well as therapies, devices and procedures currently in development and that may be developed in the future. We believe that the key competitive factors affecting the success of any of our product candidates will include efficacy, safety, speed to market, ease of use and reliability, acceptance by physicians, reimbursement and costs, level of devoted promotional activity and IP protection. Our lead product candidate, the BIM-IOL System, is designed to treat OAG and OHT, placing us in direct competition with a range of therapies, devices, procedures and technologies, including topical eye drops, laser-based interventions, MIGS, and intracameral implants. These modalities are offered by companies with significant market presence and resources. For example, we compete with alternative glaucoma surgical device and ophthalmic laser companies such as Alcon, Allergan (AbbVie), Bausch & Lomb, Glaukos, and Johnson & Johnson, as well as pharmaceutical competitors such as Alcon, Allergan (AbbVie), Astellas, Genentech (Roche) and Regeneron. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, or are easier to use, more reliable or less expensive than any of our product candidates that are approved. Our competitors also may obtain FDA or other regulatory approval for their product candidates more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. Many of our current or potential competitors, either alone or with their collaboration partners, have substantially greater financial resources and may have greater expertise in research and development, manufacturing, preclinical testing, conducting clinical trials and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical, biotechnology and ophthalmology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be strong competitors, particularly through collaborative arrangements with large and established companies. These companies also compete with us in recruiting and retaining qualified scientific and management personnel, as well as in acquiring technologies and intellectual property complementary to, or necessary for, our product candidates. Because of the size of the ophthalmology and vision correction markets and the high growth profile of such markets, we anticipate that companies will dedicate substantial resources to developing competing products. We expect that competing treatment options that are successfully developed could eventually be available both within and outside the United States. Our commercial opportunity could be impacted if competitors develop treatments and therapies that are more effective, safer, easier to use, or less costly—or if they achieve regulatory approval ahead of us. We expect that we will need substantial additional capital to complete the development and any commercialization of our current and any future product candidates, which may cause dilution to our stockholders. If we are unable to raise this capital when needed, we may be forced to delay, reduce or eliminate our research and development programs or other operations. The development of biopharmaceutical product candidates is capital-intensive. We expect to spend substantial amounts to advance our product candidates into clinical development and to complete the clinical development of, seek regulatory approvals for and commercialize our product candidates, if approved. If we obtain regulatory approval for our BIM-IOL System or any future product candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing, and distribution. Furthermore, we expect to incur additional costs associated with operating as a public company. We expect that we will require additional capital beyond the proceeds of our IPO, which we may raise through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements, to enable us to complete the development and potential commercialization of our BIM-IOL System or any future product candidates, if approved. 43 Tab l e of Contents As of December 31, 2025, we had cash and cash equivalents and short-term investments of $107.4 million. We believe that the estimated net proceeds from our IPO, together with our existing cash and cash equivalents and short-term investments, will be sufficient to fund our operating expenses and capital expenditure requirements through 2028. This estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more than currently expected because of circumstances beyond our control. Because the length of time and activities associated with successful development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any marketing and commercialization activities. We will need substantial additional capital to develop our product candidates and fund operations for the foreseeable future. Our future capital requirements will depend on many factors, including: n the scope, timing, rate of progress, and costs of our clinical trials for our current and any future product candidates; n the number and scope of clinical programs we decide to pursue; n the cost, timing, and outcome of preparing for and undergoing regulatory review of our current and any future product candidates; n the cost and timing of manufacturing our product candidates; n the costs of preparing, filing, and prosecuting patent applications and trademark applications, maintaining and enforcing our intellectual property rights, and defending intellectual property-related claims; n the terms and timing of establishing and maintaining collaborations, licenses, and other similar arrangements; n the timing of any milestone and royalty payments to our existing or future suppliers, collaborators, or licensors; n our efforts to enhance operational systems and our ability to attract, hire, and retain qualified personnel, including personnel to support the development of our product candidates; n the costs associated with being a public company; n the extent to which we acquire or in-license other product candidates and technologies; n the extent to which we enter into licensing or collaboration arrangements for any of our programs; and n the costs and timing of future commercialization activities, including manufacturing, marketing, sales, and distribution of our product candidates, if they receive marketing approval. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of common stock. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. Adequate additional financing may not be available to us when needed on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative effect on our financial condition and our ability to pursue our business strategy. In addition, attempting to secure additional financing may divert the time and attention of our management from day-to-day activities and harm our development efforts. If we are unable to raise capital when needed or on acceptable terms, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Implantation of our BIM-IOL System involves risks and may result in complications and AEs, which may limit adoption of the BIM-IOL System, if approved, and negatively affect our business, financial condition and results of operations. The BIM-IOL System is designed to be implanted into the capsular bag of the eye in connection with cataract surgery. As with any cataract surgery, there are inherent risks and potential complications involved. These risks may include, 44 Tab l e of Contents but are not limited to, infection, inflammation, bleeding, retinal detachment, increased IOP, dislocation or improper positioning of the IOL, visual disturbances and other AEs. In rare cases, these complications can result in permanent loss of vision or require additional surgical intervention to correct or remove the IOL. The safe and intended use of our BIM-IOL System depends not only on the design and quality of the system but also on the skill and experience of the surgeon performing the implantation. Variability in surgical technique, improper handling or placement of the system, or failure to follow recommended procedures could lead to higher rates of complications or AEs. Additionally, certain patient-specific factors, such as pre-existing ocular conditions or anatomical differences, may elevate the risk of complications. Negative outcomes associated with our product candidates, whether due to product-related issues, surgical error or patient factors, could result in product liability claims, increased scrutiny from regulatory authorities and negative publicity. Furthermore, reports of AEs or complications could discourage surgeons from adopting our BIM-IOL System, even if approved, or lead to reluctance among patients to undergo procedures involving our BIM-IOL System, thereby limiting our ability to achieve or maintain market acceptance. If we are unable to demonstrate the safety and effectiveness of our BIM-IOL System and obtain the approvals required for commercialization, or if AEs associated with their use become widely known following such approval for commercialization, our business, financial condition and results of operations could be materially and adversely affected. If the components of our BIM-IOL System experience mechanical failure during clinical trials or potential future commercial use, our business, financial condition and prospects could be negatively affected. Our BIM-IOL System is still under development and has not received regulatory approval for commercial sale. As with other ophthalmic implants, our BIM-IOL System incorporates delicate components, such as haptics, that are essential for proper positioning and stability within the eye. During clinical trials or potential future commercial use, mechanical failure of these components—including haptic breakage—may occur during handling, implantation, or post-operatively. Such failures could result in lens dislocation, the need for additional or unplanned surgical intervention, or other adverse clinical outcomes, including compromised visual acuity or patient dissatisfaction. If haptic breakage or other mechanical failures are observed during clinical trials, such events could delay or prevent regulatory approval, require design modifications, or necessitate additional studies. Reports of such failures could also lead to increased regulatory scrutiny, negative publicity, or reluctance among investigators, surgeons, or patients to participate in our clinical trials. Even if our BIM-IOL System ultimately receives regulatory approval, any history of mechanical failures could limit physician and patient adoption, result in product complaints, or expose us to product liability claims. Any of these events could have a material adverse effect on our business, financial condition, and prospects, and could prevent us from successfully commercializing our BIM-IOL System. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates, if approved. Our business exposes us to significant product liability risks inherent in the development, testing, manufacturing and marketing of therapeutic treatments. Product liability claims could delay or prevent completion of our development programs. If any of our product candidates are approved for marketing, such claims could still result in an FDA or other regulatory authority investigation of the safety and effectiveness of such products, our manufacturing processes and facilities or our marketing programs. These investigations could potentially lead to a recall of our products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in injury to our reputation, withdrawal of clinical trial participants, costs to defend the related litigation, a diversion of management’s time and our resources, initiation of investigations by regulators, substantial monetary awards to patients or other claimants, the inability to commercialize our product candidates and decreased demand for our product candidates, if approved for commercial sale. We currently have product liability insurance that we believe is appropriate for our stage of development and may need to obtain higher levels prior to marketing any of our product candidates, if approved. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business and cause our stock price to decline. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be 45 Tab l e of Contents unable to maintain or obtain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses, including those caused by product liability claims. Our lead product candidate, the BIM-IOL System, is designed to deliver an API that is already on the market, which exposes us to additional risks. Our BIM-IOL System is designed to deliver APIs to the eye of a subject when implanted during cataract surgery. The selected API of our BIM-IOL System, bimatoprost, is the API, a highly effective PGA that was approved by the FDA in 2001 for the reduction of elevated IOP in patients with OAG or OHT. Bimatoprost in the crystalline form we use has been in the public domain and used for the treatment of eye disorders for many years and we are therefore not able to seek and obtain patent protection for the form of crystalline bimatoprost we use in our BIM-IOL System. We cannot prevent third parties from using bimatoprost in competitor ophthalmic drug delivery products because it is in the public domain and accessible by third parties. This may permit a third party having a competing product to be more competitive against us. We purchase bimatoprost from a third-party vendor who has sold the form of bimatoprost that we use in our product candidates for many years. We cannot prevent third parties from purchasing bimatoprost from our vendor or other vendors selling bimatoprost. We cannot prevent our vendor from selling bimatoprost to third parties for their ophthalmic products, which may be similar to our BIM-IOL System or other product candidates. Our vendor does not have patent protection for the bimatoprost that we purchase. We or our vendor cannot prevent third party vendors from making and/or selling bimatoprost such as selling the third party vendors’ bimatoprost to third party competitors. Furthermore, if manufacturer demand for bimatoprost increases in the future, or if a shortage occurs, we may not be able to continue to obtain bimatoprost on commercially reasonable terms or at all, which would significantly harm our business. Similar risks will apply to the extent that we incorporate additional or different APIs that are also already in the public domain into any future product candidates we develop. In addition, although bimatoprost has been commercially available for several years, regulatory authorities may identify adverse side effects related to bimatoprost in the future. Any adverse side effects that arise from the use of any form of bimatoprost, or reporting thereof, could prevent or inhibit the commercialization of our BIM-IOL System and seriously harm our business. We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success. Because we have limited financial and managerial resources, we focus on research programs, therapeutic platforms and product candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other therapeutic platforms or product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs, therapeutic platforms and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights. Changes in U.S. trade policy, including recently announced tariffs, could have a material adverse impact on our business, financial condition, and results of operations. Changes in U.S. trade policy, including recently announced tariffs, could have a material adverse impact on our business, financial condition, and results of operations. The imposition of retaliatory or new tariffs or increases in existing tariffs on goods imported from countries where we source from third party suppliers could result in increased material costs. If we are unable to mitigate these risks through supply chain adjustments, such as changing third party suppliers, the development, testing and clinical trials of our product candidates may be delayed or infeasible, and regulatory approval or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business. Risks Related to Our Intellectual Property We depend substantially on intellectual property rights granted under our license agreement with the Regents of the University of Colorado. If we lose our existing license or are unable to acquire or license additional proprietary rights from third parties, we may not be able to continue developing our product candidates. In March 2020, we entered into an Exclusive License Agreement with the Regents of the University of Colorado (CU), which was amended in December of 2020, May of 2023, and October of 2025 (as amended, the License Agreement), 46 Tab l e of Contents pursuant to which CU granted us an exclusive, worldwide, royalty-bearing, transferable license, with the right to grant sublicenses, under certain patents and patent applications co-owned by CU and us relating to an intraocular drug dispenser (the Licensed Patents) for us to make, have made, use, import, offer to sell, sell, render and practice all products covered by the Licensed Patents (the License, and such products of the Licensed Patents) in all fields. All Licensed Patents are jointly owned by CU and us. CU retains the non-exclusive right for itself and all other not-for-profit academic and research institutions to practice all Licensed Products for educational, research, clinical, or other non-commercial purposes. The U.S. federal government retains a non-exclusive right to practice the Licensed Patents under 35 U.S.C. §§ 200-212 and 37 C.F.R. § 401, and we must use commercially reasonable efforts to cause any Licensed Products to be manufactured substantially in the United States to the extent required by 35 U.S.C. § 204. Under the License Agreement, we are obligated to use commercially reasonable efforts to develop, market and sell at least two Licensed Products in all fields worldwide, to meet certain diligence milestones by certain deadlines, and to pay CU an annual license fee, milestone payments and royalties. CU may terminate the agreement for, among other causes, our uncured material breach of the License or our failure to use commercially reasonable efforts to develop a product covered by the Licensed Patents in the territories set forth in the License, including efforts to meet the development and commercial milestones and obligations in the License Agreement, and cessation of sales of a commercially sold Licensed Product for two consecutive calendar quarters, in each case pursuant and subject to the terms of the License Agreement. Termination of this license for failure to comply with such obligations or for other reasons, or reduction or elimination of our licensed rights under it or any other license, may result in our having to negotiate new or reinstated licenses on less favorable terms or our not having sufficient intellectual property rights to operate our business. The occurrence of such events could materially harm our business and financial condition. The risks described elsewhere pertaining to our intellectual property rights also apply to the intellectual property rights that we in-licensed, and any failure by us or our licensors to obtain, maintain, defend and enforce these rights could have a material adverse effect on our business. If we are unable to obtain and maintain sufficient intellectual property protection for our technology, products and product candidates we may develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully develop and, if approved, commercialize our products may be adversely affected. Our success depends in large part on our ability to obtain and maintain patent protection in the United States and select foreign countries with respect to our BIM-IOL System and any future product candidates. We rely upon a combination of patents, trademarks and trade secret protections, and nondisclosure, confidentiality, employment agreements, work-for-hire agreements and other work-product agreements to protect the intellectual property related to our BIM-IOL System and our other product candidates. If we are unable to obtain or maintain patent protection with respect to our BIM-IOL System or any future product candidates, and their uses, our business, financial condition, resultant operations and prospects could be materially harmed. We generally seek to protect our proprietary position by filing patent applications in the United States and in certain select foreign jurisdictions including Canada, Japan, Australia, and Europe related to our BIM-IOL System and our other product candidates that are important to our business. If we fail to obtain, maintain and protect our intellectual property, third parties may be able to compete more effectively against us. In addition, we may incur substantial costs related to litigation or other patent proceedings in the United States or foreign countries in which we have sought patent prosecution in our attempts to recover losses caused by a third party or restrict use of our intellectual property by a third party. The patent prosecution process is expensive and time-consuming, and we may not be able to file, prosecute, enforce or license all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially advantageous or even in the jurisdictions where we have sought patent protection. Additionally, recent reforms, U.S. Supreme Court and Federal Circuit jurisprudence, specific governmental appointments, and changes at government agencies of the United States and those of non-U.S. jurisdictions could increase the delays, uncertainties and costs surrounding the prosecution of our patent applications, and the maintenance, enforcement, or defense of our patents. For example, the ability of the U.S. Patent and Trademark Office (USPTO) and other applicable patent authorities to properly administer their functions is highly dependent on the levels of funding available to the agency, the specific appointees positioned in the USPTO, and the USPTO’s ability to retain personnel and fill key leadership appointments, among various factors. New statutory frameworks, new case law, or USPTO rulemaking and advisement can significantly impact our ability to obtain, enforce, and defend our patents. For example, a change regarding patent eligible subject matter can have drastic effects on medical technologies, especially with respect to surgical methods and proposed methods of treatment. Termination of employees or delays in replacing or hiring for positions could significantly impact the ability of the 47 Tab l e of Contents USPTO and other applicable patent authorities to fulfill their functions and could greatly impact our ability to timely and adequately prosecute or maintain our patent applications, and our ability to timely and adequately maintain, enforce, or defend our patents. We may not be able to obtain or maintain patent applications and patents due to the subject matter claimed in such patent applications and patents being in disclosures in the public domain. It is also possible that we will fail to identify patentable aspects of our research and development output and data before it is too late to obtain patent protection because of a third party filing or a disclosure into the public domain. Moreover, if we choose to license certain patent rights now or in the future from third parties, we may not have the right to control the preparation, filing and prosecution of such patent applications, or to maintain the patents, directed to technology that we license from those third parties. We may also require the cooperation of our future licensor, if any, in order to enforce and/or defend the licensed patent rights, and such cooperation may not be provided. Therefore, any licensed patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. We cannot be certain that patent prosecution and maintenance activities by any of our future licensors have been or will be conducted in compliance with applicable laws and regulations, which may affect the validity and enforceability of such patents or any patents that may issue from such patent applications. If they fail to obtain a patent, this could cause us to lose rights in any applicable intellectual property that we in-license, and as a result our ability to develop and commercialize the BIM-IOL System and our other product candidates may be adversely affected and we may be unable to prevent competitors from making, using and selling competing products to our products or product candidates. The patent positions of companies may involve complex legal and factual questions that have been the subject of much litigation in recent years, and, therefore, the scope of any patent claims that we have or may obtain cannot be predicted with certainty. Accordingly, we cannot provide any assurances about which of our patent applications will issue, the breadth of any resulting patent, whether any of the issued patents will be found to be infringed, invalid, or unenforceable or will be threatened or challenged by third parties, that any of our issued patents have, or that any of our currently pending or future patent applications that mature into issued patents will include, claims with a scope sufficient to protect our products, services, or technology. Our pending and future patent applications may not result in the issuance of patents or, if issued, may not issue in a form that will be advantageous to us. The coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance that could narrow or otherwise alter the scope of coverage of our patent. We cannot offer any assurances that the breadth of our issued patents will be sufficient to stop a competitor from developing, manufacturing, and commercializing one or more products, services, or technologies in a non-infringing manner that would be competitive with one or more of our products, services, or technologies, or otherwise provide us with any competitive advantage. Furthermore, any successful challenge to our patents or any other patents owned by or licensed to us could deprive us of rights necessary for our commercial success. Further, there can be no assurance that we will have adequate resources to enforce our patents. The selected API of our BIM-IOL System, bimatoprost, is an approved and known pharmaceutical that has been in the public domain and used for the treatment of eye disorders for many years and we are therefore not able to seek and obtain patent protection for the form of crystalline bimatoprost we use in our BIM-IOL System. There is no assurance that all of the potentially relevant patents or patent applications relating to bimatoprost or its forms and formulations have been identified in the United States and in foreign jurisdictions, the identity of which could be asserted against our use of bimatoprost in our BIM-IOL System. A third party may hold patent protection on the API bimatoprost used in our platform in its current form. These patents may be asserted against us in litigation such as patent infringement or other cause of action, for our use of the API in our BIM-IOL System. If a patent is asserted against us, this could have a negative impact on our business. The third party holding such a patent may have substantially greater resources than we do and may have competing technologies that may limit, interfere with, or block our ability to make, have made, use, import, offer to sell, and sell our BIM-IOL System or other product candidates where the delivered drug is bimatoprost. If a patent is asserted against us, we would need to divert considerable resources and personnel to fight such an action in order to defend our position and to challenge the patent’s validity, enforceability, or scope, which may result in such asserted patents being upheld but may also result in such patent being narrowed, invalidated or held unenforceable. Such actions would require considerable resources and time distracting us from our business. We may be forced to take a license, if offered, from a third party holding such a patent for use of bimatoprost in our BIM-IOL System or other product candidates in the future. If we are unable to obtain a license under reasonable terms, we may be forced to use a different API that could be less desirable or effective in our proposed treatments. In addition, these patents could be asserted against our vendor that supplies bimatoprost to us and we could be forced to seek alternative sources of bimatoprost not protected by the patent or to seek a different API from our vendor or a different vendor to use in our BIM-IOL System. If we are forced to use a different API in our BIM-IOL System, we would have to expend considerable resources and time assessing a replacement API that is at least as effective as bimatoprost and in developing and testing the new API in our BIM-IOL System, which may cause significant additional expenses for example, when manufacturing or seeking regulatory approval for a replacement API in our BIM-IOL System. 48 Tab l e of Contents If the patent applications we hold or may in-license in the future with respect to our BIM-IOL System and product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for our BIM-IOL System or any future product candidate, it could dissuade other companies from collaborating with us to develop product candidates, and threaten our ability to commercialize the BIM-IOL System or future product candidates. Any such outcome could have a material adverse effect on our business. The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents and patent applications may be challenged in the courts or patent offices in the United States and our selected foreign jurisdictions. Patents that have issued may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. An adverse decision in any such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technologies and products, or limit the duration of the patent protection of our technology and product candidates. Additionally, an adverse decision in any such challenge can impact the validity or enforceability of other patents of ours that are not part of the adverse decision but related to our challenged patents. Generally, issued patents are granted a term of 20 years from the earliest claimed non-provisional filing date. In certain instances, patent term can be adjusted to recapture a portion of delay incurred by the USPTO in examining the patent application (patent term adjustment) if the delays by the USPTO outnumber the days of delay created by the patentee in the examination process. The scope of patent protection may also be limited as a result of successful challenges or other processes available to narrow the scope of claims of a patent post issuance. Without patent protection for our BIM-IOL System or future product candidates, we may be open to competition from similar or the same products as our product candidates. Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with a duration of patent protection rights of sufficient length to exclude others from commercializing products similar or identical to our product candidates. The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our potential future collaborators will be successful in protecting our BIM-IOL System or our other product candidates by obtaining and defending patents. Pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent is issued for such applications. The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our potential future development partners will be successful in protecting our BIM-IOL System or our other product candidates by obtaining and defending patents. These risks and uncertainties include the following: n the USPTO and various foreign governmental patent agencies where we have pursued patent protection require compliance with a number of procedural, documentary, fee payment structure and other provisions during the patent prosecution process and maintenance thereof, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; n the USPTO requires us to disclose all material references to the USPTO and to the Patent Examiner during prosecution of our patent applications at the USPTO, and failure to do so could result in a third party identifying material references unknown to us and successfully challenging our ability to obtain a patent, maintain a patent or enforce a patent against an infringer; n patent applications may not result in any patents being issued; n patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage against third party competitors; n our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with, reduce or block our ability to make, have made, use, import, offer to sell, and sell our BIM-IOL System or other product candidates; n there could be delays at the USPTO caused by staffing cuts and other U.S. government actions as a result of the U.S. Department of Government Efficiency or other executive actions to reduce the size of the U.S. government and in particular the USPTO staff; 49 Tab l e of Contents n there may be significant pressure on the U.S. government and foreign governmental bodies to limit the scope of patent protection both inside and outside the United States for use of our BIM-IOL System or other product candidates in the treatment of eye-related conditions that prove successful, as a matter of public policy regarding U.S and foreign health concerns; and n countries other than the U.S. may have patent laws less favorable to patentees than patent laws in the U.S. Patent Office or those upheld by U.S. courts in as far as obtaining and enforcing patent rights, allowing foreign competitors a better opportunity to create, develop and market competing products. The patents and patent applications that we own or license may fail to result in patents with claims that protect our BIM-IOL System, development programs or any future product candidate in the United States or in other foreign countries of which we seek protection. There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found, which can prevent a patent from issuing from a pending patent application or can be used to invalidate a patent. Even if patents do successfully issue and even if such patents cover our BIM-IOL System or any future product candidate, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated or held unenforceable. Any successful opposition to these patents or any later obtained patents owned by, or licensed to us could deprive us of rights necessary for the successful commercialization of our BIM-IOL System or any other product candidates that we may develop. Further, the scope and coverage of our patents may be so narrow that a third party could design around our patents and therefore, not infringe our patent(s). Further, if we encounter delays in issuance of a patent and/or regulatory approvals, the period during which we could market a product candidate under patent protection could be reduced. Any of the foregoing events could have a material adverse effect on our business, financial condition, results of operations, and prospects. U.S. and foreign patent laws relating to the patentability of certain inventions in drug delivery technology, medical device and medical product industry are uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain patents in the future. Changes in either patent laws or interpretation of patent laws in the United States or in other jurisdictions could increase the uncertainties and costs surrounding the prosecution of patent applications, the grant of patents, and the enforcement or defense of patents. In the last fifteen years, the U.S. Congress made sweeping changes to patent law in passing the America Invents Act (AIA). Additionally, appointed government officials to the USPTO or that control the USPTO processes can participate in selective enforcement making selective decisions and rule-making that can affect the issuance and/or enforceability and/or post-grant challenges to the validity of our patent(s) and patent applications. These changes include, among others, allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by the USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold our claim invalid even though the same evidence would be insufficient to invalidate our claim if first presented in a district court action. The AIA also provides that an administrative tribunal known as the Patent Trial and Appeals Board (PTAB), provides a venue for challenging the validity of patents at a cost that is much lower than district court litigation and on timelines that are much faster. Although it is not clear what, if any, long-term impact the PTAB proceedings will have on the operation of our business, the initial results of patent challenge proceedings before the PTAB since its inception in 2013 have resulted in the invalidation of many U.S. patent claims. The availability of the PTAB as a lower-cost, faster and potentially more potent process for challenging patents could increase the likelihood that our patents will be challenged, thereby increasing the uncertainties and costs of maintaining and enforcing them. The changes brought about by the AIA can increase the costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects. Various courts, including the U.S. Supreme Court, have rendered decisions that impact the scope of patentability of certain inventions or discoveries relating to our technology and commercial goals. Specifically, these decisions have substantially increased the probability that patent claims will be ruled patent ineligible for reciting a natural phenomenon, law of nature or abstract idea. Furthermore, in view of these decisions, since December 2014, the USPTO has published and continues to publish revised guidelines for patent examiners to apply to pending patent applications when examining claims for patent eligibility. Patent eligibility guidelines vary by country and patent claims that may be subject matter eligible in the United States may not be eligible in another foreign jurisdiction. For example, as compared to the United States, our ability to obtain claims to medical methods is more limited in Europe, Japan and Canada. Additionally, enforcement and recoverable damages in the United States based on patent claims to medical methods have limitations that may affect our ability to enforce certain patent claims. 50 Tab l e of Contents Actions taken by the U.S. Congress, federal courts and USPTO have from time to time narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in some situations. Similar changes have been made by authorities in other foreign jurisdictions. In addition to increasing uncertainty with regard to our ability to obtain patents, such changes create uncertainty with respect to the value of patents, once obtained. Depending on decisions by authorities in the United States and in selected foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that may have a material adverse effect on our ability to obtain new patents and to defend and enforce our existing patents and patents that we might obtain in the future. We cannot be sure that our patent portfolio will not be negatively impacted by the current uncertain state of the law, new court rulings or changes in guidance or procedures issued by governments or patent offices around the world. From time to time, the U.S. Supreme Court, other federal courts, the U.S. Congress or the USPTO may change the standards of patentability, scope and validity of patents within the drug delivery and medical device technology areas and any such changes, or any similar adverse changes in the patent laws of other foreign jurisdictions, could have a negative impact on our business, financial condition, prospects and results of operations. In addition, on June 1, 2023, the European Union Patent Package (EU Patent Package) regulations were implemented with the goal of providing a single pan-European Unitary Patent (Unitary Patent) and a new European Unified Patent Court (UPC) for litigation involving European patents. As a result, all European patents, including those issued prior to ratification of the EU Patent Package, now by default automatically fall under the jurisdiction of the UPC, unless otherwise selecting a different course by opting out at the time of grant. It is uncertain how the UPC will impact granted European patents in the biotechnology, medical products and pharmaceutical industries. Our European patent applications, if granted and not opted out, could be challenged in the UPC. During the first seven years of the UPC’s existence, the UPC legislation allows a patent owner to opt its European patents out of the jurisdiction of the UPC. We have already opted out of the UPC for one European patent and may decide to opt out our other future European patents from the UPC, but doing so may preclude us from realizing the benefits of the UPC. Moreover, if we do not meet all of the formalities and requirements for opt-out under the UPC, our current or future European patents could remain under the jurisdiction of the UPC. The UPC provides our competitors with a forum to centrally revoke our European patents and allow for the possibility of a competitor to obtain a pan-European injunction. Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize our technology and our product candidates due to increased competition and, resultantly, affecting our business, financial condition, results of operations and prospects. The UPC and Unitary Patent are significant changes in European patent practice. As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation in the UPC. Patent terms may be inadequate to protect our competitive position on our BIM-IOL System or other product candidates for an adequate amount of time. Patent rights are of limited duration. In the United States, if all maintenance fees are paid timely, the natural expiration of a patent is generally 20 years after its first effective filing date. However, the actual protection afforded by a patent varies from country to country, and depends on many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patent. Various extensions may be available, but the life of a patent, and the protection it affords is limited. Only a single patent can be extended for each marketing approval under the FDA, and any patent can be extended only once, for a single product. Moreover, the scope of protection during the period of the patent term extension does not extend to the full scope of the claims, but instead only to the scope covering the product as approved. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such product candidates are commercialized. Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from third-party products. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing product candidates similar or identical to ours. Upon issuance in the United States, the term of a patent may be increased by patent term adjustment, which is based on certain delays caused by the USPTO, but this increase can be reduced or eliminated based on certain delays caused by the patentee during patent prosecution. The term of a U.S. patent may also be shortened if the patent is terminally disclaimed over an earlier-filed patent. Depending upon the timing, duration and specifics of FDA marketing approval of our BIM-IOL System and future product candidates, one or more of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments as a 51 Tab l e of Contents combination drug and device FDA-approved product. The Hatch-Waxman Amendments permit a patent restoration term of up to five years and is based on the first approved use of a combination product and is limited to only one patent that covers the approved combination product, the approved use of the combination product, or a method of manufacturing the combination product. Such patent term extension (PTE) cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. However, the applicable authorities, including the FDA and the USPTO, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. We may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. PTE is only relevant after a patent has been issued. If the USPTO or other foreign patent office delays issuance of a patent, this can affect the number of days awarded that extend patent term. The PTE is awarded based upon the FDA’s regulatory review period, but the PTE evaluation stage involves cooperation between the USPTO and the FDA. Reduced personnel and increased workload of USPTO examiners can affect issuance of a patent and if delayed, shortens the number of PTE days eligible for award. Administrative changes (e.g., at the FDA or USPTO) may also lead to delays in review and analysis of regulatory submissions or requests for PTE. If we are unable to extend the expiration date of our existing patents or obtain new patents covering our product(s) with prolonged expiry dates, our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data to obtain approval of competing products following our patent expiration and launch their product earlier than might otherwise be the case. If PTE is unavailable, reduced or not awarded, our ability to prevent third parties from selling products that infringe our patent subject to PTE covering our ophthalmic drug delivery product candidates or other future product candidates can be reduced where our patents could expire sooner if PTE is reduced or not awarded. Laws governing PTE in foreign jurisdictions where we have pursued patent protection analogous to U.S. PTE vary widely, as do laws governing the ability to obtain multiple patents from a single patent family. Additionally, we may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory review process, apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. If we are unable to obtain PTE or patent term restoration, or the term of any such extension is less than we request, the period during which we will have the right to exclude others from marketing our product in the specific jurisdiction will be shortened and our competitors may obtain approval of competing products following our patent expiration and may take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data to launch their product earlier than might otherwise be the case, and our revenue could be reduced, possibly materially. We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our product candidates. As the drug delivery and medical device industries expand and more patents are issued, the risk increases that our BIM-IOL System or our other product candidates may be subject to claims of infringement of the patent rights of third parties. There can be no assurance that our operations do not, or will not in the future, infringe, misappropriate or otherwise violate existing or future third-party patents or other intellectual property rights in the United States or foreign jurisdictions. Identification of third-party patent rights that may be relevant to our operations is difficult because patent searching is imperfect due to differences in terminology among patents, varied public access when comparing searching programs, incomplete databases and the difficulty in assessing the meaning of patent claims. We cannot provide any assurances that third-party patents do not exist which might be enforced against our existing product candidates or current technology, including our BIM-IOL System or any of our future product candidates, their respective methods of use, and manufacture thereof, and could result in either an injunction prohibiting our manufacture or future sales, or, with respect to our future sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties, which could be significant. We cannot guarantee that any of our patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States that is relevant to or necessary for the commercialization of our BIM-IOL System and future product candidates in any jurisdiction. Numerous U.S. and foreign patents and patent applications exist in our market that are owned by third parties. Our competitors in both the United States and in foreign jurisdictions, many of which have substantially greater resources and have made substantial investments in patent portfolios and competing technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make, use, offer to sell and sell our BIM-IOL System or our other product candidates. Patents and patent applications in foreign jurisdictions can be harder to find and therefore, it is possible that we will not be able to identify patent or patent applications relevant to our product candidates. We do not always conduct independent reviews of pending patent applications and patents issued to third parties. Patent applications in the United States and 52 Tab l e of Contents certain foreign countries are typically published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Certain U.S. applications that will not be filed outside the United States can remain confidential until a patent issues and therefore, remains confidential from the public until such time. In addition, patent applications in the United States and certain foreign jurisdictions can be pending for many years before issuance, or unintentionally abandoned patents or applications can be revived. Furthermore, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our BIM-IOL System or our other product candidates or the use of our BIM-IOL System or our other product candidates. As such, there may be applications of others now pending or recently revived patents of which we are unaware. These patent applications may later result in issued patents, or the revival of previously abandoned patents, that may be infringed by the manufacture, use or sale of our BIM-IOL System or our other product candidates or will prevent, limit or otherwise interfere with our ability to make, use, offer to sell, or sell our BIM-IOL System or our other product candidates. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a patent application may be incorrect, which may negatively impact our ability to market our product candidates, if approved. For example, we may incorrectly determine that our BIM-IOL System or our other product candidate(s) are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or foreign jurisdictions that we consider relevant may be incorrect, and our failure to identify and correctly interpret relevant patents may negatively impact our ability to obtain patents covering our product candidates(s) and develop and market our product candidates. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our product candidates, if approved. Obtaining and maintaining our patent protection depends on compliance with various procedural processes, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements. Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and/or patent applications will be due to be paid to the USPTO and certain foreign patent agencies in several stages over the lifetime of our patents and patent applications. The USPTO and various foreign patent agencies require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application and patent maintenance process if not complied with by us, can lead to a shortened life of our patents or our patent applications and the patents or patent applications can go abandoned without the ability to revive. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules in the USPTO, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application in the United States or foreign jurisdictions, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees, failure to pay an annuity by a final deadline, failure to pay a grant or issue fee by a final deadline, and failure to properly legalize and submit formal documents without the ability to cure. We employ reputable law firms and other professionals to help us comply with these provisions. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. If we or any of our licensors fail to maintain the patents and patent applications covering the BIM-IOL System or any future product candidate, our competitors may be able to enter the market with products similar or the same as ours without risk of infringement, which would have an adverse effect on our business, financial conditions, results of operations and growth prospects. We may become involved in third-party claims of intellectual property infringement, which may delay or prevent the development and commercialization of our BIM-IOL System and any future product candidate. Our commercial success depends in part on our ability to develop, manufacture, market and sell our BIM-IOL System and any future product candidates, while avoiding infringement and other violations of the patents and proprietary rights of third parties. There is a substantial amount of litigation and other adverse proceedings, both within and outside the United States, involving patent and other intellectual property rights in the drug delivery, medical device and medical device therapeutic delivery system industries, including patent infringement lawsuits, international trade commission (ITC)-related lawsuits that affect import of products that infringe third party patents (e.g., Section 337 of the U.S. Tariff Act of 1930), interferences, derivation, and administrative law proceedings, inter partes review, ex parte re-examinations, and post-grant review before the USPTO, as well as oppositions and similar processes in foreign jurisdictions. We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights who allege that our BIM-IOL System or our other product candidates, uses and/or other 53 Tab l e of Contents proprietary technologies infringe their intellectual property rights. Companies in the drug delivery and medical device industry have used intellectual property litigation to gain a competitive advantage. Our commercial success depends in part upon our ability and that of our CMOs and suppliers to manufacture, market, and sell our product candidates, if approved, and to use our proprietary technologies without infringing, misappropriating or otherwise violating the proprietary rights or intellectual property of third parties. We may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our BIM-IOL System, our other product candidates and any future product candidates and technology, whether or not we are actually infringing, misappropriating or otherwise violating the rights of third parties. Numerous U.S. and foreign patents and pending patent applications, which are owned by third parties, exist in the fields in which we and our collaborators are developing product candidates. As the drug delivery and medical device industries expand and more patents are issued, and as we gain greater visibility and market exposure as a public company, the risk increases that our BIM-IOL System or our other product candidates or other business activities may be subject to claims of infringement of the patent and other proprietary rights of third parties. Third parties may assert that we are infringing their patents or employing their proprietary technology without authorization, regardless of the merit of such claims. Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could have a negative impact on our ability to commercialize our current and any future product candidates. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this is a high burden and requires us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. Moreover, given the vast number of patents in our field of technology, we cannot be certain that we do not infringe existing patents or that we will not infringe patents that may be granted in the future. While we may decide to initiate proceedings to challenge the validity of these or other patents in the future, we may be unsuccessful, and courts or patent offices in the United States and abroad could uphold the validity of any such patent. Furthermore, because patent applications can take many years to issue and may be confidential for 18 months or more after filing, and because pending patent claims can be revised before issuance, there may be applications now pending which may later result in issued patents that may be infringed by the manufacture, use or sale of our BIM-IOL System or our other product candidates. Regardless of when filed, we may fail to identify relevant third-party patents or patent applications, or we may incorrectly conclude that a third-party patent is invalid or not infringed by our BIM-IOL System or our other product candidates or activities. If a patent holder believes that our product candidate our BIM-IOL System infringes its patent, the patent holder may sue us even if we have received patent protection for our technology. Moreover, we may face patent infringement claims from nonpracticing entities that have no relevant product revenue and against whom our own patent portfolio may thus have no deterrent effect. If a patent infringement suit were threatened or brought against us, we could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the actual or threatened suit. Moreover, individuals and groups that are non-practicing entities, commonly referred to as “patent trolls,” purchase patents and other intellectual property assets for the purpose of making claims of infringement in order to extract settlements. From time to time, we may receive threatening letters, notices or “invitations to license,” or may be the subject of claims that our product candidates and business operations infringe or violate the intellectual property rights of others that include these patent trolls. Also, there may be third-party patents or patent applications with claims to materials, drug delivery features, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our current and future product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our current or future product candidates may infringe. In addition, third parties may obtain patent rights in the future and claim that use of our technologies infringes their rights. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our product candidates, cover important features of our product candidate methods of treating certain diseases or conditions that we are pursuing with our product candidates, our BIM-IOL System or any final product itself, the holders of any such patents may be able to block our ability to commercialize such product candidate unless we obtained a license under the applicable patents, or until such patents expire. Such a license may not be available on commercially reasonable terms or at all. In addition, we may be subject to claims that we are infringing other intellectual property rights, such as trademarks or copyrights, or misappropriating trade secrets of others, and to the extent that our employees, consultants or contractors use intellectual property or proprietary information owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our BIM-IOL System and future product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a 54 Tab l e of Contents substantial diversion of employee resources from our business. In the event of a successful infringement or other intellectual property claim against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our affected product candidates, which may be impossible or require substantial time and monetary expenditure. We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain additional licenses from third parties to advance our research or allow commercialization of our BIM-IOL System or our other product candidates. We may fail to obtain any of these additional licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialize our BIM-IOL System or other product candidates, which could harm our business significantly. The acquisition or licensing of third-party intellectual property rights is a competitive area, and our competitors may pursue strategies to acquire or license third party intellectual property rights that we may consider attractive or necessary. If we are unable to successfully obtain rights to required third party intellectual property rights or maintain the existing intellectual property rights we have, we may have to abandon development of the relevant product candidates or redesign those product candidates that contain the allegedly infringing intellectual property, which could harm our business, financial condition and results of operations. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. A finding of infringement could force us to cease some of our business operations, which could materially harm our business. We cannot provide any assurances that third-party patents do not exist which might be enforced against our BIM-IOL System or our other product candidates, resulting in either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties under terms of a license agreement or other forms of compensation to third parties. During the course of any intellectual property litigation, there could be public announcements of the litigation such as commencement of a litigation, results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of our existing products, product candidates, programs or intellectual property could be diminished. Accordingly, the market price of shares of our common stock may decline. Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business. Because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. Even if we ultimately prevail, a court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may not be an adequate remedy. Furthermore, even if resolved in our favor, the monetary cost of such litigation and the diversion of the attention of our management could outweigh any benefit we receive as a result of the proceedings. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our business. Any of the foregoing may cause us to incur substantial costs and could place a significant strain on our financial resources, divert the attention of management from our core business, and harm our reputation. We may become involved in lawsuits to protect or enforce our patents or other intellectual property rights, or the patents or other intellectual property rights of our licensors, which could be expensive, time consuming, and unsuccessful, and could result in a court or administrative body finding our patents to be invalid or unenforceable. Competitors may challenge, infringe or otherwise violate our co-owned licensed patents, or our other intellectual property rights. To counter challenges, infringement or unauthorized use or misappropriations, we or any future licensors may be required to file or defend legal claims against us, which can be expensive and time-consuming. In addition, in such a proceeding, a court may decide that one or more patent of ours or any of our current or future licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing. The initiation of a claim against a third party may also cause the third party to bring counter claims against us such as claims asserting that our patents are invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged for failure to meet any of several statutory requirements, including lack of inventiveness, obviousness, non-enablement, insufficient written description, or failure to claim patent-eligible subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent or that we withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter partes review, or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation. 55 Tab l e of Contents Additionally, delays caused by the federal agencies may increase the period that we are subject to such claims. For example, administrative changes, including reduced personnel, change of personnel and budgets experienced by the Patent and Trial Appeal Board, could further delay our ability to timely challenge any such patents. The outcome following legal assertions of invalidity and unenforceability is unpredictable. In any patent infringement proceeding, there is a risk that even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that it or any future licensors’ patent claims do not cover the invention, or decide that the other party’s use of our or any future licensors’ patented technology falls under the safe harbor to patent infringement under 35 U.S.C. §271(e)(1). An adverse outcome in a litigation or proceeding involving our co-owned or any future licensors’ patents could limit our ability to assert our or any future licensors’ patents against those parties or other competitors and may curtail or preclude our ability to exclude third parties from making, importing and selling similar or competitive products. Any of these occurrences could adversely affect our competitive position, and our business, financial condition, results of operations and prospects. Similarly, if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks. We cannot be certain that any of our licensors or future licensors have rights to the inventions covered by our licenses or future licenses. Our current or future licensors may have relied on third-party consultants or collaborators or on funds from third parties, such as the U.S. government, such that our licensors are not the sole and exclusive owners of the patents we in-license. If third parties have ownership rights or other rights to our co-owned licensed patents or patent applications, they may be able to license such patents or patent applications to our competitors, and our competitors could market competing products and technology. This could adversely affect our competitive position, business, financial condition, results of operations, and prospects. We cannot be certain that any of our licensors or future licensors are not violating rights of a third party. We cannot be certain that there is no invalidating prior art to our patents or licensed patents, of which we, our licensors, and the patent examiner were unaware during prosecution. For any patents and patent applications that we may license from third parties, we may have limited or no right to participate in the defense of such licensed patents against challenge by a third party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our current or future product candidates. Such a loss of patent protection could harm our business. We may not be able to prevent, alone or with our licensors or licensees, misappropriation of our intellectual property rights, particularly in countries of where we have or have not filed our patent applications where the laws may not protect those rights as fully as in the United States. Our business could be harmed if in litigation, the prevailing third-party does not offer us a license on commercially reasonable terms. Any litigation or other proceedings to enforce our intellectual property rights may fail, and even if successful, may result in substantial costs and distract our management and other employees. Because competition in our industry is intense, competitors may infringe or otherwise violate our co-owned licensed patents or other intellectual property. To counter infringement or unauthorized use, we may be required to file a lawsuit, which can be expensive and time consuming, and could distract our technical and management personnel from their normal responsibilities. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims or file administrative actions against us alleging that we infringe their patents or that our patents are invalid. In addition, in a patent infringement proceeding, a court may decide that our patent is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding or administrative action could put one or more of our patents at risk of being invalidated or interpreted narrowly. Our competitors may assert invalidity on various grounds, including lack of novelty, obviousness or that we were not the first applicant to file a patent application related to our product. We may elect to enter into license agreements in order to settle patent infringement claims or to resolve disputes before litigation, and any such license agreements may require us to pay royalties and other fees that could be significant. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure. Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the commencement of such a proceeding, results of hearings, motions or other interim 56 Tab l e of Contents proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our common stock. Moreover, we cannot be assured that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings. Because of the expense and uncertainty of litigation, we may conclude that even if a third party is infringing our patents, any patents that may be issued as a result of our future patent applications, or other intellectual property rights, the risk-adjusted cost of bringing and enforcing such a claim or action may be too high or not in the best interest of our company or our stockholders. In such cases, we may decide that the more prudent course of action is to simply monitor the situation or initiate or seek some other non-litigious action or solution in relation to the third-party activities. Such actions, while prudent, may impact our ability to enforce our patents or recover damages in future proceedings or litigations. We may not be able to protect our intellectual property rights in the United States and foreign jurisdictions which we have filed for intellectual property protection, which could impair our business. Patents are of national or regional effect, and filing, prosecuting, and defending patents covering our BIM-IOL System and any future product candidate throughout the world would be prohibitively expensive; therefore, we have pursued patent coverage in the United States, and in a limited number of foreign jurisdictions. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions where we are pursuing patent protection. Consequently, we may not be able to prevent third parties from practicing our or any future owned or licensed inventions in all countries outside the United States, even in jurisdictions where we pursue patent protection, or from selling or importing products made using our or any future inventions in and into the United States or foreign jurisdictions. Competitors may use our or any future technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may have or are seeking to obtain patent protection, but where patent enforcement is not as strong as that in the United States. These third-party competitors’ products may compete with our product candidates in such jurisdictions and take away our market share where we do not have any issued or licensed patents and any future patent claims, and other intellectual property rights may not be effective or sufficient to prevent them from manufacturing. Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, which could make it difficult for us to stop the infringement of our patents, or manufacturing of our product or future products, or marketing of competing products in violation of our intellectual property and proprietary rights generally. We currently have no patents or patent applications filed or pending in developing countries. In certain developing countries, companies could manufacture, sell and/or use our BIM-IOL System or future product without infringement. In addition, certain jurisdictions do not protect to the same extent or at all inventions that constitute methods of treatment. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights in the jurisdictions of where we seek patent protection may be inadequate to obtain a significant commercial advantage for the product candidates that we develop and market. Furthermore, while we intend to protect our intellectual property rights in our selected significant markets, we have limited resources and cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our BIM-IOL System or our other product candidates. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate, which may have an adverse effect on our ability to successfully commercialize our BIM-IOL System or any of our future product candidates in all of our selected significant foreign markets. Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws within the United States. We may need to share our trade secrets and proprietary know-how with 57 Tab l e of Contents current or future partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and those affiliated with or controlled by state actors. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and in the foreign jurisdictions of which we seek patent protection and intend to market our BIM-IOL System and other future products. In addition, some courts inside and outside the United States are sometimes less willing or unwilling to protect trade secrets. If we choose to go to court to stop a third party from using any of our trade secrets, we may incur substantial costs. Even if we are successful, these types of lawsuits may consume our time and other resources. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects. The legal systems in certain countries may also favor state-sponsored or companies headquartered in particular jurisdictions over our first-in-time patents and other intellectual property protection. We are aware of incidents where such entities have stolen the intellectual property of domestic companies in order to create competing products and we believe we may face such circumstances ourselves in the future. For example, through its “Annual Special 301 Report on Intellectual Property,” the Office of the United States Trade Representative has been reporting on the adequacy and effectiveness of intellectual property protection in a number of foreign countries that are U.S. trading partners and their protection and enforcement of intellectual property rights. Placement of a country on the Priority Watch List indicates that particular problems exist in that country with respect to intellectual property protection, enforcement, or market access for persons relying on intellectual property rights. Countries placed on the Priority Watch List are the focus of increased bilateral attention concerning the specific problem areas. It is possible that we will not be able to enforce our intellectual property rights against third parties that misappropriate our proprietary technology in those countries. Moreover, geo-political actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any current or future licensors and the maintenance, enforcement or defense of our issued patents or those of any current or future licensors. Government actions may also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of our future Russian patents or patent applications, resulting in partial or complete loss of patent rights in Russia. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and may export otherwise infringing products to territories where we have patent protection, but enforcement rights are not as strong as those in the United States. These products may compete with our products and our patents or other IP rights may not be effective or sufficient to prevent them from competing. If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. In addition to the protection afforded by patents, we may seek to rely on trade secret protection to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce, processes that are better protected by trade secret than a limited patent term, and any other elements of our product discovery and development processes that involve proprietary know-how, information, or technology that is not covered by our patents. We may not be able to meaningfully protect our trade secrets. Although we require all of our employees to assign their inventions to us, and require all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information, or technology to enter into confidentiality agreements and we have confidential agreements with respect to our trade secrets, we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed to our competitors or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws within the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and in foreign jurisdictions where we seek to maintain protection of our trade secrets. If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline. Because we expect to collaborate with third parties on the continuing development of the BIM-IOL System and any future product candidates, we must, at times, share trade secrets with them. We also expect to conduct research and development (R&D) programs that may require us to share trade secrets under the terms of our partnerships or agreements with CROs. We seek to protect our proprietary technology in part by entering into agreements containing confidentiality and use restrictions and obligations, including material transfer agreements, consulting agreements, manufacturing and supply agreements, confidentiality agreements or other similar agreements with our advisors, employees, contractors, CMOs, CROs, other service providers and consultants prior to disclosing proprietary 58 Tab l e of Contents information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, including our trade secrets. Despite the contractual provisions employed by us when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known to unauthorized personnel or by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these contractual agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure could impair our competitive position and may have an adverse effect on our business and results of operations. In addition, these agreements typically restrict the ability of our advisors, employees, third-party contractors, CMOs, CROs, other service providers and consultants to publish data potentially relating to our trade secrets, because our agreements contain certain limited publication rights. Despite our efforts to protect our trade secrets, our trade secrets and other know-how may get published by advisors, employees, third-party contractors, CMOs, CROs, other service providers or consultants. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publication of information by any of our third-party collaborators. A competitor’s discovery of our trade secrets could impair our competitive position and have an adverse impact on our business. Monitoring unauthorized disclosure and detection of unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. If we were to enforce a claim that a third party had illegally obtained and was using our trade secrets, it would be expensive and time-consuming to investigate and pursue action against this unauthorized disclosure, and the outcome would be unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. If we choose to go to court to stop a third party from using any of our trade secrets, we may incur substantial costs. These lawsuits may consume our time and other resources even if we are successful. For example, significant elements of our product candidates, including confidential aspects of methods of manufacturing, assembly and related processes, are based on unpatented trade secrets. Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees and consultants, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology. We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties or claims asserting ownership of what we regard as our own intellectual property. We employ individuals who were previously employed at other biotechnology, pharmaceutical, medical technology and ophthalmology companies, or at research institutions, including our competitors or potential competitors. Although we take steps to ensure that our employees, consultants and advisors comply with any ongoing obligations to former employers and other third-parties, and do not use the proprietary information or know-how of third parties, including former employers, in their work for us, we may be subject to claims that these individuals have violated their contractual obligations with former employers or other third party and/or improperly retained proprietary information of a former employer, or such individuals or we have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s former employer. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of our employees’ former employers or other third parties or used this information in their employment or other engagement with us. Litigation may be necessary to defend against these claims. For example, we are currently a defendant in a litigation filed by one of our competitors, Glaukos Corporation, in the United States District Court for the Central District of California alleging, among other claims, that we and one of our employees misappropriated Glaukos’ trade secrets and confidential information. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or be enjoined from using or relying on certain intellectual property. An inability to incorporate such technologies or features would harm our business and may prevent us from successfully commercializing our technologies, our BIM-IOL System or our other product candidates. In addition, we may lose personnel as a result of such claims and any such litigation, or the threat thereof, may adversely affect our ability to hire employees or contract with independent contractors. A loss of key personnel or their work product could hamper or prevent our ability to commercialize our technologies or product candidates, which could adversely affect our business, financial condition, results of operations and prospects. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management. 59 Tab l e of Contents Our employees, consultants or independent contractors may wrongfully use or disclose confidential information of ours to the public or third-party competitor and we could fail to protect potential intellectual property rights and other important information identified in the confidential information. Although we seek to protect our confidential information by ensuring that our agreements with our employees, collaborators, and other third parties with whom we do business include provisions requiring non-disclosure of confidential information, our employees, collaborators, and other third parties with whom we do business could disclose our confidential information to the public or third-party competitors. Disclosure of our confidential information related to the SpyGlass Platform, the BIM-IOL System, or any other current or future product candidates could harm our business. Litigation or other courses of action may be needed to enforce our contract against our employees, former employees, collaborators, or other third parties with whom we do business. This would divert significant resources and funding to enforce such an action. These disclosures of confidential information could harm our business. We may be subject to claims that former employers, consultants or other third parties have an ownership interest in our patents or patent applications as an inventor or co-inventor. We may be subject to claims that our current or former employees, contractors, or other third parties have an ownership interest in our current or future patents, patent applications, or other intellectual property rights, including as an inventor or co-inventor. We may be subject to ownership or inventorship disputes in the future arising, for example, from conflicting obligations of employees, consultants, or others who were or are involved in developing our product candidates, services, or technologies. The failure to name the proper inventors on a patent application can result in the patents issuing thereon being unenforceable. Inventorship disputes may arise from conflicting views regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties involved in developing our BIM-IOL System or our other our product candidates or as a result of questions regarding co-ownership of potential joint inventions. Litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership. Alternatively, or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property. There is no guarantee of success in defending these claims, and if we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such challenges may also result in our inability to develop, manufacture or commercialize our technologies, our BIM-IOL System and our other and product candidates without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future technologies and product candidates. Even if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees. Any of the foregoing could adversely affect our business, financial condition, results of operations and prospects. If our trademarks, future trademarks and trade names are not adequately protected, then we may not be able to build brand recognition in our markets of interest and our business may be adversely affected. We intend to use registered or unregistered trademarks or trade names to brand and market ourselves and our product candidates. Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. During trademark registration proceedings, we may receive rejections of our applications by the USPTO or in other foreign jurisdictions of which we seek trademark protection. Although we are given an opportunity to respond to such rejections, we may be unable to overcome them. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, which may not survive such proceedings. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected. We may license our trademarks and trade names to third parties, such as distributors. Though these license agreements may provide guidelines for how our trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names. Our efforts to enforce or protect our proprietary rights related to trademarks, trade names, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our financial condition or results of operations. 60 Tab l e of Contents In addition, any proprietary name we propose to use with our current or future product candidates in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of the potential for confusion with other product names. If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in effort to identify a suitable proprietary product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark. Intellectual property rights do not necessarily address all potential threats to our competitive advantage. The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage. The following examples are illustrative: n formulations and compositions of therapeutic agents used in our BIM-IOL System and any future product candidates may be old, unable to obtain patent protection, may be in the public domain and we may not be able to preclude others from using active ingredients of our BIM-IOL System and any future product candidates in third-party ophthalmic therapies; n others may be able to make formulations or compositions that are the same as or similar to our current and future active ingredients of use in our BIM-IOL System and any future product candidates, but that are not covered by the pending patent applications or patents that we co-own or any pending patent applications or patents that we may in-license in the future; n others may be able to make product that is similar to our current and future product candidates we intend to commercialize that is not covered by the patents that we exclusively licensed and have the right to enforce; n we, any of our future licensors or collaborators might not have been the first to make the inventions covered by the patents or pending patent applications that we co-own or may in-license in the future; n we or any of our future licensor might not have been the first to file patent applications covering certain of our or their inventions; n others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing or otherwise violating our owned intellectual property rights or any patent applications that we may license in the future; n it is possible that our pending patent applications or those that we may own or license in the future will not result in a patent; n patents that we either co-own or that we may own or license in the future may be revoked, modified or held valid or unenforceable, as a result of legal challenges by our competitors; n patents that we either co-own or that we may own or license in the future may not provide us with any competitive advantages; n others may have access to the same intellectual property rights licensed to us in the future on a non-exclusive basis; n our competitors might conduct research and development activities in the United States and other countries that we seek patent protection for our inventions, that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; n we may not develop additional proprietary technologies that are patentable; n we cannot predict the scope of protection of any patent based on our or any future licensors’ patent applications, including whether the patent applications that we co-own, or, in the future, in-license will result in a patent with claims directed to our BIM-IOL System or our other product candidates or uses thereof in the United States or in other foreign countries of which we seek patent protection; n the claims of any patent based on our patent applications may not provide protection against competitors or any competitive advantages, or may be challenged by third parties; n if enforced, a court may not hold that our patents are valid, enforceable or infringed; n we may need to initiate litigation or administrative proceedings to enforce and/or defend our patent rights which will be costly whether we win or lose; 61 Tab l e of Contents n we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual property; n we may fail to adequately protect and police our trademarks and trade secrets; and n the patents of others may have an adverse effect on our business, including if others obtain patents claiming subject matter similar to or an improvement on inventions covered by our patent applications. If we fail to comply with our obligations under any license, collaboration or other agreements, such agreements may be terminated, we may be required to pay damages, and we could lose intellectual property rights that are necessary for developing and protecting our product candidates. We currently rely on certain intellectual property rights licensed from third parties for the development and commercialization of our BIM-IOL System and our other product candidates, including under the License Agreement described above. We may in the future also need to obtain additional licenses or otherwise acquire development or commercialization rights to current and future product candidates or data from third parties. If any future licensors fail to prosecute, maintain, enforce, and defend such patents, or lose rights to those patents, the rights we have licensed may be reduced or eliminated, and our right to develop and commercialize future product candidates that may be subject of such licensed rights could be adversely affected. In spite of our efforts, any future licensors might conclude that we are in material breach of obligations under our license agreements. If we breach any material obligations, or use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture, and sell product candidates that are covered by the licensed technology or enable a competitor to gain access to the licensed technology. If such in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, our competitors will have the freedom to seek regulatory approval of, and to market, products identical to our product candidates and the licensors to such in-licenses could prevent us from developing or commercializing product candidates that rely upon the patents or other intellectual property rights which were the subject matter of such terminated agreements. Any of these events could adversely affect our business, financial condition, results of operations, and prospects. Disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including: n the scope of rights granted under the license agreement and other interpretation-related issues; n our financial or other obligations under the license agreement; n whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to or covered by the licensing agreement; n our right to sublicense patents and other rights under our grant of manufacture and sales and collaborative development relationships to third party sublicensees; n our sublicensees rights to further sublicense rights under our license agreement; n our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our BIM-IOL System and future product candidates, and what activities satisfy those diligence obligations; n our right to transfer or assign the license to a third party; n the inventorship or ownership of inventions and know-how resulting from the joint creation or use of intellectual property by any of our licensors and us and our partners; and n the priority of invention of patented technology. If disputes over intellectual property that we license prevent or impair our ability to maintain our licensing arrangements on acceptable terms, we may not be able to successfully develop and commercialize the affected product candidates, which would have a material adverse effect on our business. In addition, certain of our current or future agreements with third parties may limit or delay our ability to consummate certain transactions, may impact the value of those transactions, or may limit our ability to pursue certain activities. Further, we or our current or future licensors, if any, may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Therefore, we may miss potential opportunities to strengthen our patent position. It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for example with 62 Tab l e of Contents respect to proper priority claims, inventorship listings, ownership, claim scope, timely filed responses, timely paid fees, timely filed terminal disclaimers and other filings, submissions of relevant references, or timely requests for patent term adjustments. If our current or future licensors are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there are material defects in the form, preparation, prosecution, or enforcement of our patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in a patent or a valid or enforceable patent if challenged. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business. In addition, even where we have the right to control patent prosecution of patents and patent applications under a license, we may still be adversely affected or prejudiced by actions or inactions of our predecessors or licensors and their counsel that took place prior to us assuming control over patent prosecution. Our acquired technologies and current or future licensed technology may be subject to retained rights. Our predecessors or licensors may retain certain rights under their agreements with us, including the right to use the underlying technology for noncommercial academic and research use, to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of information relating to the technology. It is difficult to monitor whether our predecessors or future licensors limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to our licensed technology in the event of misuse. Results of future research covered by or relevant to our co-owned licensed patent rights could be disclosed in a public forum prior to our being able to file a patent application to protect any new discoveries resulting from such research and could result in the inability to protect these inventions in the United States or desired foreign jurisdiction. If we are limited in our ability to utilize acquired technologies or current or future licensed technologies, or if we lose our rights to critical acquired or in-licensed technology, we may be unable to successfully develop, out-license, market and sell our product candidates, which could prevent or delay new product introductions. Our business strategy depends on the successful development of acquired technologies, and current or future licensed technology, into commercial products. Therefore, any limitations on our ability to utilize these technologies may impair our ability to develop, out-license or market and sell any product candidate. Any collaboration or partnership arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our products. Any future collaborations that we enter into may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborations are subject to numerous risks, which may include that: n collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations; n collaborators may not pursue development and commercialization of our products or may elect not to continue or renew development or commercialization programs based on trial or test results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities; n collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our current and future product candidates; n a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities; n we could grant exclusive rights to our collaborators that would prevent us from collaborating with others; n collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; n disputes may arise between us and a collaborator that cause delay or termination of the research, development or commercialization of our current or future product candidates or that results in costly litigation or arbitration that diverts management attention and resources; n collaborations may be terminated, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future product candidates; 63 Tab l e of Contents n collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; and n a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings. We may not be able to license or acquire additional or necessary intellectual property rights or technology from third parties. We currently have rights to intellectual property covering our BIM-IOL System and our other product candidates. Because our development programs may in the future require the use of additional proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license, or use these third-party proprietary rights. Further, other parties, including our competitors, may have patents and have filed and are likely filing patent applications potentially relevant to our business. In order to avoid infringing these patents, we may find it necessary or prudent to obtain licenses to such patents from such parties. The licensing or acquisition of intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. No assurance can be given that we will be successful in licensing any additional rights or technologies from third parties. Our inability to license the rights and technologies that we have identified, or that we may in the future identify, could have a material adverse impact on our ability to complete the development of our product candidates or to develop additional product candidates. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. Failure to obtain any necessary rights or licenses may detrimentally affect our planned development of our current or future product candidates and could increase the cost, and extend the timelines associated with our development, of such other product candidates, and we may have to abandon development of the relevant program or product candidate. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects. We may enter into license agreements in the future with others to advance our existing or future research or allow commercialization of our existing or future product candidates. These licenses may not provide exclusive rights to use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and product candidates in the future. In that event, we may be required to expend significant time and resources to redesign our product candidates, or the methods for manufacturing them, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize the affected product candidates, which could harm our business, financial condition, results of operations, and prospects significantly. We cannot provide any assurances that third-party patents do not exist which might be enforced against our current manufacturing methods, product candidates, or future methods or product candidates resulting in either an injunction prohibiting our manufacture or future sales, or, with respect to our future sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties, which could be significant. Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers. Our licensed patents and patent applications may have been or may be in the future supported through the use of U.S. government funding awarded by the National Institute of Health or other federal agency or the FDA Office of Orphan Products Development and the Army Medical Research and Development Command. We may have licensed, or may acquire or license in the future, intellectual property rights that have been generated through the use of U.S. government funding or grant. Pursuant to the Bayh-Dole Act of 1980, the U.S. government has certain rights in inventions developed with government funding. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions covered by the government funding for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require a patentee to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (1) adequate steps have not been taken to commercialize the invention; (2) government action is necessary to meet public health or safety needs; or (3) government action is necessary to meet requirements for public use under federal regulations (march-in rights). The U.S. government also has the right to take title to these inventions if the grant recipient or associated institution fails to disclose the invention to the government, fails to reference the 64 Tab l e of Contents government funding in a patent application or patent, or fails to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. The U.S. government may require that the inventions be solely produced in the United States or impute substantial tariffs if manufactured in a foreign jurisdiction. This preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property. Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties. Because of the expense and uncertainty of litigation, we may conclude that even if a third-party is infringing our issued patent, any patents that may be issued as a result of our pending or future patent applications or other intellectual property rights, the risk-adjusted cost of bringing and enforcing such a claim or action may be too high or not in the best interest of our company or our stockholders, or it may be otherwise impractical or undesirable to enforce our intellectual property against some third parties. Our competitors or other third parties may be able to sustain the costs of complex patent litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. In such cases, we may decide that the more prudent course of action is to simply monitor the situation or initiate or seek some other non-litigious action or solution. In addition, the uncertainties associated with litigation could compromise our ability to raise the funds necessary to continue our clinical trials, continue our internal research programs, in-license needed technology or other product candidates, or enter into development partnerships that would help us bring our product candidates to market. Risks Related to Development, Regulatory Approval and Commercialization The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to generate product revenue and our business will be substantially harmed. We are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA. Foreign regulatory authorities impose similar requirements. The time required to obtain approval by the FDA and other comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other data. Even if we eventually complete clinical testing and receive approval of any marketing application for our product candidates, the FDA and other comparable foreign regulatory authorities may approve our product candidates for a more limited indication or a narrower patient population than we originally requested. We have not obtained regulatory approval for any product candidate, and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory approval. Of the large number of drugs in development, only a small percentage successfully complete the applicable regulatory approval processes and are commercialized. Prior to obtaining approval to commercialize a product candidate in the United States or abroad, we must demonstrate with substantial evidence from adequate and well-controlled clinical trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such product candidates are safe and effective for their intended uses. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe available nonclinical or clinical data support the safety or efficacy of our product candidates, such data may not be sufficient to obtain approval from the FDA and other comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authorities, as the case may be, may also require us to conduct additional preclinical studies or clinical trials for our product candidates either prior to or post-approval, or may object to elements of our clinical development program. 65 Tab l e of Contents Applications for our product candidates may be delayed or limited or could fail to receive regulatory approval for many reasons, including the following: n the FDA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials; n the FDA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective for their intended uses, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use; n the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full patient population for which we seek approval; n the FDA or other comparable foreign regulatory authorities may not accept clinical data from trials that are conducted at clinical facilities or in countries where the standard of care is potentially different from that of their own country; n the FDA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; n the data collected from clinical trials of our product candidates may not be sufficient to support a submission to obtain regulatory approval in the United States or elsewhere; n we may be unable to demonstrate to the FDA or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable; n the FDA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; n the approval policies or regulations of the FDA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval; and n the FDA or other comparable foreign regulatory authorities may not accept a submission due to, among other reasons, the content or formatting of the submission. With respect to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may involve additional product testing, administrative review periods and agreements with pricing authorities. Even if we obtain approval of our product candidates, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may impose significant limitations in the form of narrow indications, warnings, or a Risk Evaluation and Mitigation Strategy (REMS). Regulatory authorities may not approve the price we intend to charge for products we may develop, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could seriously harm our business. The clinical trials of our product candidates may not demonstrate safety and efficacy to the satisfaction of the FDA or other comparable foreign regulatory authorities or otherwise produce positive results. Before obtaining marketing approval from the FDA or other comparable foreign regulatory authorities for the sale of our product candidates, we must complete preclinical development and extensive clinical trials to demonstrate the safety and efficacy of our product candidates. Clinical testing is expensive, difficult to design and implement, can take many years to complete and its ultimate outcome is uncertain. A failure of one or more clinical trials can occur at any stage of the process. The outcome of preclinical studies and early stage clinical trials may not be predictive of the success of later clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs. We do not know whether our future clinical trials will begin on time or enroll patients on time, or whether our ongoing and/or future clinical trials will be completed on schedule or at all. Clinical trials can be delayed for a variety of reasons, including delays related to: n the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical studies; 66 Tab l e of Contents n obtaining regulatory authorizations to commence a trial or reaching a consensus with regulatory authorities on trial design; n any failure or delay in reaching an agreement with CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; n obtaining approval from one or more institutional review boards (IRBs); n IRBs refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial; n changes to clinical trial protocol; n clinical sites deviating from trial protocol or dropping out of a trial; n manufacturing sufficient quantities of product candidate or obtaining sufficient quantities of combination therapies for use in clinical trials; n subjects failing to enroll or remain in our trial at the rate we expect, or failing to return for post- treatment follow-up; n subjects choosing an alternative treatment for the indication for which we are developing our product candidates, or participating in competing clinical trials; n lack of adequate funding to continue the clinical trial; n subjects experiencing severe or unexpected treatment-related AEs; n occurrence of serious adverse events (SAEs) in trials of the same class of agents conducted by other companies; n selection of clinical end points that require prolonged periods of clinical observation or analysis of the resulting data; n a facility manufacturing our product candidates or any of their components being ordered by the FDA or comparable foreign regulatory authorities to temporarily or permanently shut down due to violations of current good manufacturing practice (cGMP) regulations or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process; n any changes to our manufacturing process that may be necessary or desired; n third-party clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, good clinical practices (GCP) or other regulatory requirements; n third-party contractors not performing data collection or analysis in a timely or accurate manner; or n third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications. Clinical trials must be conducted in accordance with the FDA’s and other applicable regulatory authorities’ legal requirements, and remain subject to oversight by these governmental agencies and ethics committees or IRBs at the medical institutions where such clinical trials are conducted. We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA or comparable foreign regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial. Further, conducting clinical trials in foreign countries, as we may do for our product candidates, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries. 67 Tab l e of Contents Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates. If we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenues from any of these product candidates will be delayed. Moreover, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval process and jeopardize our ability to commence product sales and generate revenues. In addition, many of the factors that cause, or lead to, termination or suspension of, or a delay in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Any delays to our clinical trials that occur as a result could shorten any period during which we may have the exclusive right to commercialize our product candidates and our competitors may be able to bring products to market before we do, and the commercial viability of our product candidates could be significantly reduced. Any of these occurrences may harm our business, financial condition and prospects significantly. Enrollment and/or retention of patients in clinical trials is an expensive and time-consuming process subject to various external factors beyond our control that may cause delays in the clinical development of our product candidates. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of eligible patients who remain in the trial until its conclusion. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials to such trial’s conclusion as required by the FDA or other comparable foreign regulatory authorities. Patient enrollment is a significant factor in the timing of clinical trials. We completed enrollment in our Phase 1/2 multi-center, randomized clinical trial in November 2024 and subsequently initiated and are currently enrolling two registrational Phase 3 clinical trials. Any difficulties we experience relating to enrollment in any clinical trial could delay the clinical development of our product candidates and our planned timeline to submit an NDA to the FDA. We may experience difficulty in patient enrollment in our clinical trials for a number of reasons. Patient enrollment may be affected if our competitors have ongoing clinical trials for product candidates that are under development for the same indications as our product candidates, and patients who would otherwise be eligible for our clinical trials instead enroll in clinical trials of our competitors’ product candidates. Patient enrollment depends on many other factors, including: n size and nature of the patient population required for analysis of the trial’s endpoints; n availability and efficacy of approved drugs and other competing therapeutic candidates for the condition under investigation; n the patient eligibility and exclusion criteria for the trial in question as defined in the protocol; n our ability to recruit clinical trial investigators with the appropriate competencies and experience; n the design of the clinical trial; n perceived risks and benefits of the product candidate under study; n physicians’, surgeons’ and participants’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating; n participant referral practices of physicians and surgeons; n the ability to monitor participants adequately during and after treatment; n proximity and availability of clinical trial sites for prospective trial patients; n continued enrollment of prospective patients by clinical trial sites; and 68 Tab l e of Contents n the risk that patients enrolled in clinical trials will drop out of the trials before completion. Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidates, hindering their clinical development, and jeopardize our ability to obtain marketing approval for the sale of our product candidates. Furthermore, we expect to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and we will have limited influence over their performance. Even if we are able to enroll a sufficient number of patients for our clinical trials, we may have difficulty maintaining enrollment of such patients in our clinical trials. If our product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials, we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Patients in our ongoing and planned clinical trials may in the future suffer SAEs or other side effects not observed in our preclinical studies or previous clinical trials. If SAEs or other side effects are observed in any of our ongoing or planned clinical trials, we may have difficulty recruiting patients to the clinical trials, or we may be required to abandon the trials or our development efforts of that product candidate altogether. We, the FDA, other comparable regulatory authorities or an IRB may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects. Even if the side effects do not preclude the product candidate from obtaining or maintaining regulatory approval, undesirable side effects may inhibit market acceptance due to tolerability concerns as compared to other available therapies. Any of these developments could materially harm our business, financial condition and prospects. Additionally, if any of our product candidates receives regulatory approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result. For example, the FDA could require us to adopt a REMS, to ensure that the benefits of treatment with such product candidate outweigh the risks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education, extensive patient monitoring or distribution systems and processes that are highly controlled, restrictive and more costly than what is typical for the industry. We may also be required to adopt a REMS or engage in similar actions, such as patient education, certification of health care professionals or specific monitoring, if we or others later identify undesirable side effects caused by any product that we develop alone. Other potentially significant negative consequences associated with AEs include: n we may be required to suspend marketing of a product, or we may decide to remove such product from the marketplace; n regulatory authorities may withdraw or change their approvals of a product; n regulatory authorities may require additional warnings on the label or limit access of a product to selective specialized centers with additional safety reporting and with requirements that patients be geographically close to these centers for all or part of their treatment; n we may be required to create a medication guide outlining the risks of a product for patients, or to conduct post-marketing studies; n we may be required to change the way a product is administered; n we could be subject to fines, injunctions, or the imposition of criminal or civil penalties, or be sued and held liable for harm caused to subjects or patients; and n a product may become less competitive, and our reputation may suffer. Any of these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achieving or maintaining market acceptance of our product candidates, if approved by the FDA or other regulatory authorities. Interim, initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. From time to time, we may publicly disclose interim, preliminary or top-line data from our preclinical studies and clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as 69 Tab l e of Contents patients from our clinical trials continue other treatments for their condition. Preliminary or top-line data also remain subject to FDA audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim, preliminary and top-line data should be viewed with caution until the final data are available. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the top-line or preliminary results that we report may differ from future results of the same studies or trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and could have a material adverse effect on the success of our business. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the interim, top-line or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, results of operations, prospects or financial condition. Further, disclosure of interim, top-line or preliminary data by us or by our competitors could result in volatility in the price of our common stock. If the FDA does not conclude that a product candidate satisfies the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements under Section 505(b)(2) are not as we expect, the approval pathway for our product candidates in this pathway will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful. We believe that certain of our product candidates, including our BIM-IOL System will be regulated under the drug provisions of the FDCA, enabling us to submit NDAs for approval of such product candidates in the United States. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, added Section 505(b)(2) to the FDCA. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Section 505(b)(2), if applicable to us under the FDCA, would allow an NDA we submit to the FDA to rely in part on data in the public domain or on the FDA’s prior conclusions regarding the safety and effectiveness of approved compounds, which could expedite the development program for our product candidates by potentially decreasing the amount of nonclinical and/or clinical data that we would need to generate in order to obtain FDA approval. If the FDA does not allow us to pursue the Section 505(b)(2) regulatory pathway for a product candidate as anticipated, we may need to conduct additional clinical trials, provide additional data and information and meet additional standards for regulatory approval. If this were to occur, the time and financial resources required to obtain FDA approval for our product candidates, and complications and risks associated with our product candidates, would likely substantially increase. Moreover, inability to pursue the Section 505(b)(2) regulatory pathway could result in competitive products reaching the market before our product candidates, which could impact our competitive position and prospects. Even if we are allowed to pursue the Section 505(b)(2) regulatory pathway, we cannot assure you that our product candidates will receive the requisite approvals for commercialization, or that a competitor would not obtain approval first, or that such competitor would not obtain regulatory exclusivities from the FDA that could delay potential approval of our product. In addition, notwithstanding the approval of a number of products by the FDA under Section 505(b)(2) over the last few years, some pharmaceutical companies and others have objected to the FDA’s interpretation of Section 505(b)(2). If the FDA’s interpretation of Section 505(b)(2) is successfully challenged, the FDA may be required to change its Section 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA that we submit under Section 505(b)(2). In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are subject to certain requirements designed to protect the patent rights of sponsors of previously approved drugs that are referenced in a Section 505(b)(2) NDA. These requirements may give rise to patent litigation and mandatory delays in approval of our NDAs for up to 30 months or longer depending on the outcome of any litigation. It is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products. If successful, such petitions can significantly delay, or even prevent, the approval of a new product. Even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition. In addition, even if 70 Tab l e of Contents we are able to utilize the Section 505(b)(2) regulatory pathway, there is no guarantee this pathway will ultimately streamline the development of our product candidates or result in an approval on any timeline. Additional time may be required to obtain regulatory approval for our product candidates because they are combination products. We are developing our product candidates, including the BIM-IOL System, as drug-led, drug-device combination products. We anticipate that, if successfully developed, our product candidates would be regulated as combination products by the FDA and other regulatory authorities. Combination products require coordination within the FDA and similar foreign regulatory agencies for review of the drug and device components. For example, we expect that the FDA’s review of a marketing application for the BIM-IOL System may include the participation of both the FDA’s Center for Drug Evaluation and Research and the FDA’s Center for Devices and Radiological Health. Although the FDA and similar foreign regulatory agencies have systems in place for the review and approval of drug-led combination products, we may experience delays in the development and commercialization of our product candidates due to regulatory timing constraints and uncertainties in the product development and approval process. Moreover, although we anticipate that the device component of any combination product candidates we develop will be reviewed within the usual time frames expected for the underlying drug component application, and that no separate marketing application for the device components of such product candidates will be required in the United States, the FDA or comparable regulatory authorities may delay approval or require us to conduct additional studies with the device which may delay the approval of the combination product. In addition, to date, the FDA has not requested a separate medical device authorization submission for our IOL and proprietary drug pads. However, the FDA may request a separate medical device submission for the BIM-IOL System in the future or other future product candidates, which could significantly delay the development and commercialization of our combination product candidates. Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay. As product candidates progress through preclinical and clinical trials to marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize yield and manufacturing batch size, minimize costs and achieve consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commercialize our product candidates, if approved, and generate revenue. Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions. Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion and pricing of the product candidate in those countries. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional nonclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, the pricing of a prescription drug candidate is subject to regulatory approval before it can be sold in that jurisdiction. In some cases, the price that we intend to charge for our products, if approved, is also subject to approval. We may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products, if approved, in certain countries. If we or any future collaborator fail to comply with the regulatory requirements in international markets or fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our potential product candidates will be harmed. 71 Tab l e of Contents We have conducted, are currently conducting, and may in the future conduct, clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials. We have conducted, are currently conducting, and may in the future conduct, clinical trials outside the United States. We expect to continue to conduct trials internationally in the future. The acceptance of data from clinical trials conducted outside the United States or another jurisdiction by the FDA or comparable foreign regulatory authorities may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United States population and United States medical practice, (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations, and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for regulatory approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar requirements for clinical data gathered outside of their respective jurisdictions. In addition, such foreign trials are subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop being delayed or not receiving approval for commercialization in the applicable jurisdiction. Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory oversight, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates. Even if we obtain any regulatory approval for one or more of our product candidates, such product candidates will be subject to ongoing regulatory requirements applicable to manufacturing, labeling, packaging, storage, advertising, promoting, sampling, record-keeping and submission of safety or other post-market information, among other things. Any regulatory approvals that we receive for our product candidates will require surveillance to monitor the safety and efficacy of the product candidate, as well as ongoing compliance with cGMP and GCPs for any clinical trials. The FDA may also require a REMS, limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, or requirements that we conduct potentially costly post-market testing and surveillance studies, including post-marketing clinical trials and surveillance to monitor the quality, safety and efficacy of the drug. An unsuccessful post-marketing study or failure to complete such a study may require a REMS in order to approve our product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, drug manufacturers are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA or foreign marketing application. If we, the FDA or a comparable foreign regulatory authority, discover previously unknown problems with our product candidates, such as AEs of unanticipated severity or frequency, or problems with the facility where the drug is manufactured or if a regulatory authority disagrees with the promotion, marketing or labeling of that drug, a regulatory authority may impose restrictions relative to that drug, the manufacturing facility or us including requesting a recall or requiring withdrawal of the drug from the market or suspension of manufacturing. Failure to comply with applicable regulatory requirements following approval of any product candidates, may result in, among other things: n restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market or voluntary or mandatory product recalls; n manufacturing delays and supply disruptions where regulatory inspections identify observations of noncompliance requiring remediation; n revisions to the labeling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings; 72 Tab l e of Contents n imposition of a REMS, which may include distribution or use restrictions; n requirements to conduct additional post-market clinical trials to assess the safety of the product; n suspension or withdrawal of regulatory approvals; n issuance of fines, untitled letters, warning letters or holds on clinical trials; n refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of approvals; n product seizure or detention, or refusal to permit the import or export of our product candidates; and n injunctions or the imposition of civil or criminal penalties. The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity. The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, we may be subject to enforcement action, and we may not achieve or sustain profitability. We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. It is difficult to predict how current and future legislation, executive actions, and litigation, including the executive orders, will be implemented, and the extent to which they will impact our business, our clinical development, and the FDA’s and other agencies’ ability to exercise their regulatory authority, including FDA’s pre-approval inspections and timely review of any regulatory filings or applications we submit to the FDA. To the extent any executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. The FDA strictly regulates marketing, labeling, advertising and promotion of prescription drugs. These regulations include standards and restrictions for direct-to-consumer advertising, industry-sponsored scientific and educational activities, promotional activities involving the internet and off-label promotion. Any regulatory approval that the FDA grants is limited to those specific diseases and indications for which a product is deemed to be safe and effective by FDA. While physicians in the United States may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, our ability to promote any approved products will be narrowly limited to those indications that are specifically approved by the FDA. If we are found to have promoted such off-label uses, we may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion any product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition. Since we use the same drug delivery technology for all of our product candidates, if any of our product candidates demonstrates unanticipated biocompatibility, usability, performance or safety issues in a clinical or nonclinical study, our entire pipeline may be adversely affected. All of our current product candidates utilize the same sustained release drug delivery technology, which comprise non-bioerodible drug pads that are designed to deliver the drug into the eye without breaking down or changing their structure or shape. While our lead product candidate, the BIM-IOL System, has been well tolerated in clinical trials to date, patients may in the future experience different or more severe AEs. Any failure of a product candidate, or a component thereof, to demonstrate adequate biocompatibility, usability, performance or safety could adversely affect the development, approval, or commercialization of any other product candidate utilizing the same or similar technology, including a suspension or delay of all ongoing development for future product candidates. 73 Tab l e of Contents Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement policies, as well as pricing regulations. Sales of any of our product candidates that receive marketing approval will depend substantially, both in the United States and internationally, on the extent to which the costs of our product candidates will be covered and reimbursed by government and third-party payors. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize an adequate return on our investment. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. There is significant uncertainty related to government and third-party payor coverage and reimbursement of newly approved products. In the United States, for example, the Centers for Medicare & Medicaid Services (CMS), an agency within the U.S. Department of Health and Human Services (HHS), determines whether and to what extent a new product will be covered and reimbursed under Medicare. Private third-party payors often follow CMS’s decisions regarding coverage and reimbursement to a substantial degree. However, one third-party payor’s determination to provide coverage for a product candidate does not assure that other payors will also provide coverage for the product candidate. As a result, the coverage determination process is often time-consuming and costly. This process will require us to provide scientific and clinical support for the use of our products, if approved, to each third-party payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. We anticipate that third-party payors will cover and reimburse providers for the bimatoprost delivered using the BIM-IOL System, if approved, similar to other physician-administered drugs. J-Codes are codes maintained by CMS, which are a component of the Healthcare Common Procedure Coding System and are typically used to report injectable drugs that ordinarily cannot be self-administered. We do not have a specific J-Code for any of our product candidates. If our product candidates are approved, we may apply for one but cannot guarantee that a J-Code will be granted. To the extent separate coverage or reimbursement is available for any product candidate, if approved, and a specific J-Code is not available, physicians would need to use a non-specific miscellaneous J-Code to bill third-party payors for these physician-administered drugs. Because miscellaneous J-Codes may be used for a wide variety of products, health plans may have more difficulty determining the actual product used and billed for the patient. These claims must often be submitted with additional information and manually processed, which can create delays in claims processing times as well as increasing the likelihood for claim denials and claim errors. In addition, since our drug delivery technology is implanted into the eye via an existing procedure (cataract surgery) we believe that physicians will be able to use the existing Category I Current Procedural Terminology (CPT) codes without needing to establish a new procedure code. The CPT Editorial Panel, appointed by the American Medical Association (AMA) Board of Trustees, is responsible for maintaining and updating the CPT code set. We may apply for a new add-on Category III CPT code for the loading, implantation and position of the Drug Pad-IOL System. Category III codes are a set of temporary codes maintained by the AMA for emerging technology, services and procedures. Payment for these services or procedures are based on the coverage policies of individual payors, including private insurers and government-funded programs. Additionally, there is no guarantee that these billing codes or the payment amounts, if any, associated with such codes will be sufficient to successfully commercialize any approved product and, even if adequate payment amounts are obtained, they could change in the future. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Further, such payors are increasingly challenging the price, examining the medical necessity and reviewing the cost effectiveness of medical product candidates. There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs. Third-party payors may limit coverage to specific product candidates on an approved list, known as a formulary, which might not include all FDA-approved drugs for a particular indication. We may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and cost effectiveness of our product candidates. Nonetheless, our product candidates may not be considered medically necessary or cost effective. We cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be. Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost containment initiatives in Europe, Canada and other countries has and will continue to put pressure on the pricing and usage of therapeutics such as our product candidates. In many countries, particularly the countries of the European Union, medical product prices are subject to varying price control mechanisms as part of national health systems. In these countries, pricing negotiations with governmental authorities can take considerable time after a product receives marketing approval. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the 74 Tab l e of Contents cost-effectiveness of our product candidate to other available therapies. In general, product prices under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our products, if approved, may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits. If we are unable to establish or sustain coverage and adequate reimbursement for any future product candidates from government and third-party payors, the adoption of those products and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market or sell those product candidates, if approved. Coverage policies and government and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. Disruptions at the FDA, the Securities and Exchange Commission (the SEC) and other government agencies caused by funding shortages, global health concerns, staffing limitations or otherwise could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business. The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. For example, in recent years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, the current U.S. Presidential administration has issued certain policies and executive orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities. If a prolonged government shutdown occurs, or if renewed global health concerns, funding shortages or staffing limitations hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other such regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a public company, future government shutdowns or delays could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations. We may face difficulties from changes to current regulations and future legislation. Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, we may be subject to enforcement action, and we may not achieve or sustain profitability. In the United States, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system in ways that could affect our future revenue and profitability and the future revenue and profitability of our potential customers. Federal and state lawmakers regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. For example, one of the most significant healthcare reform measures in decades, the Patient Protection and Affordable Care Act of 2010 (ACA), was enacted in 2010. The ACA contains a number of provisions, including those governing enrollments in federal healthcare programs, reimbursement 75 Tab l e of Contents changes and fraud and abuse measures, all of which will impact existing government healthcare programs and will result in the development of new programs. Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA. In June 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA without specifically ruling on the constitutionality of the ACA. Thus, the ACA remains in force in its current form. In addition, other legislative changes have been proposed and adopted since the ACA was enacted. The Budget Control Act of 2011, among other things, reduced Medicare payments to providers, effective on April 1, 2013, and, due to subsequent legislative amendments to the statute, will remain in effect through 2032, with the exception of a temporary suspension from May 1, 2020, through March 31, 2021, unless additional Congressional action is taken. Additionally, the American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), enacted on April 16, 2015, repealed the formula by which Medicare made annual payment adjustments to physicians and replaced the former formula with fixed annual updates and a new system of incentive payments that are based on various performance measures and physicians’ participation in alternative payment models such as accountable care organizations. There likely will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care. We cannot predict the initiatives that may be adopted in the future or their full impact. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of health care may adversely affect: n our ability to set a price that we believe is fair for our products; n our ability to generate revenue and achieve or maintain profitability; and n the availability of capital. There has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted legislation designed, among other things, to bring more transparency to product pricing, to review the relationship between pricing and manufacturer patient programs, and to reform government program reimbursement methodologies for pharmaceutical products. For example, in August 2022, Congress passed the Inflation Reduction Act of 2022 (IRA), which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare Part D drugs in 2023, negotiations began in 2024, and the negotiated maximum fair price for each drug has been announced. CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027. For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected. HHS has and will continue to issue and update guidance as these programs are implemented, although the Medicare drug price negotiation program is currently subject to legal challenges. Various industry stakeholders, including certain pharmaceutical companies and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the price negotiation provisions of the IRA are unconstitutional. The current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S. Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the United States. If HHS begins to set most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or increases generic and biosimilar drug entry sooner than expected, that can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future. We cannot predict the full impact of the executive orders focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures 76 Tab l e of Contents that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the United States. Such cost containment policies and executive orders could substantial