LENZ Therapeutics, Inc. 10-Q

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis provides information that our management believes is relevant to an assessment and understanding of LENZ’s consolidated results of operations and financial condition. The discussion should be read together with the condensed consolidated financial statements and the accompanying notes to those statements that are included elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and the related notes included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024. This discussion may contain forward-looking statements based upon current expectations that involve risks and uncertainties. LENZ’s actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the section titled “Risk Factors” as set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q. Unless otherwise indicated or the context otherwise requires, references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section to “LENZ OpCo,” “LENZ,” “the Company,” “we,” “us,” “our” and other similar terms refer to the business and operations of LENZ OpCo prior to the Merger and to LENZ and its consolidated subsidiary following the Merger. While the legal acquirer in the Merger was Graphite, for financial accounting and reporting purposes under U.S. GAAP, LENZ OpCo was the accounting acquirer and the Merger was accounted for as a “reverse recapitalization.” A reverse recapitalization (i.e., a capital transaction involving the issuance of stock by Graphite for LENZ OpCo’s stock) does not result in a new basis of accounting, and the consolidated financial statements of the combined entity represent the continuation of the consolidated financial statements of LENZ OpCo in many respects. Accordingly, the consolidated assets, liabilities and results of operations of LENZ OpCo became the historical consolidated financial statements of the combined company, and Graphite’s assets, liabilities and results of operations were consolidated with those of LENZ OpCo beginning on the acquisition date. Operations prior to the Merger will be presented as those of LENZ OpCo in future reports. Graphite’s assets and liabilities were measured and recognized at their fair values as of the closing of the Merger. Overview We are a commercial pharmaceutical company focused on the commercialization of VIZZ ™ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. We are commercializing VIZZ in the United States and continue to establish licensing partnerships internationally to provide access to VIZZ globally. We believe that a once-daily pharmacological eye drop that can effectively and safely improve near vision throughout the full workday, without the need for reading glasses, is a highly attractive commercial product with an estimated U.S. market opportunity in excess of $3 billion. It is our goal to successfully commercialize VIZZ, and we have assembled an executive team with extensive clinical and commercial experience to execute this goal and become the category leader. VIZZ (aceclidine ophthalmic solution) 1.44% is a once-daily eye drop developed to restore clear near vision for up to 10 hours. VIZZ is powered by aceclidine, highlighted by its differentiated mechanism of action as a predominantly pupil-selective miotic that interacts with the iris, with minimal ciliary muscle stimulation. VIZZ contracts the iris sphincter muscle resulting in a pinhole effect and uniquely achieves a sub-2mm pupil that extends depth of focus to significantly improve near vision without causing a myopic shift. Aceclidine, the sole active ingredient in VIZZ, is a new chemical entity (“NCE”) in the United States and its FDA approval marks a global first in the treatment of presbyopia. VIZZ has patent protection until 2044 in the United States, at a minimum, due to a robust intellectual property portfolio underpinned by issued patents. On July 31, 2025, the FDA approved VIZZ, making it the first and only aceclidine-based product approved by the FDA. VIZZ has five years of NCE exclusivity in the United States, expiring in July 2030. The Company commercially launched VIZZ in the U.S. in August 2025, with direct-to-eye care professional sales and marketing activities initiated immediately upon approval. Professional product sample distribution by the sales force to optometrists and ophthalmologists and commercial product shipments to customers via our e-pharmacy partner were initiated in October 2025, and we anticipate product will be broadly available in retail pharmacies in the middle of the fourth quarter of 2025. Financial Overview As of September 30, 2025 , we had $202.2 million of cash, cash equivalents, restricted cash, and marketable secu rities. We believe that our existing cash, cash equivalents and marketable securities as of September 30, 2025 will allow us to 24 Table of Contents continue to commercialize VIZZ, and will be sufficient to fund the Company to positive operating cash flow. We have incurred net losses in each year since inception, and as of September 30, 2025 , we had an accumulated deficit of $191.2 million . These losses have resulted principally from costs incurred in connection with research and development activities and selling, general and administrative costs associated with our operations. We expect to continue to incur significant expenses related to product sales, marketing, manufacturing, and distribution of VIZZ as we begin commercialization, and additional costs associated with being a public company, including audit, legal, regulatory and tax-related services associated with maintaining compliance with an exchange listing and SEC requirements. As a result of these and other factors, and while we believe that our existing cash, cash equivalents and marketable securities as of September 30, 2025 will fund the Company to positive operating cash flow, it is possible that we may require additional financing to fund our operations and planned growth. Since our inception, we have financed our operations primarily through public offerings of our common stock, proceeds from the Merger, and private placements of our common stock and convertible preferred stock. Concurrent with the closing of the Merger on March 21, 2024, we completed a private placement (the “March 2024 PIPE Financing”) of 3,559,565 shares of common stock for an aggregate gross purchase price of $53.5 million. Additionally, on July 17, 2024, we completed a private placement (the “July 2024 PIPE Financing”) with Ridgeback Capital Investments, L.P. of 1,578,947 shares of common stock for an aggregate gross purchase price of $30.0 million. As of September 30, 2025, we have sold an aggregate of 920,500 shares of common stock under the sales agreement with TD Securities (USA) LLC (the “Sales Agreement”) , resulting in net proceeds to the Company of $26.1 million. As of September 30, 2025, the Company had $123.5 million of capacity remaining under the Sales Agreement. In October 2025, the Company sold an aggregate of 2,698,134 shares of common stock at a weighted-average price of $45.79 under the Sales Agreement, utilizing the remaining capacity under the Sales Agreement. License Agreements CORXEL License and Collaboration Agreement In April 2022, we entered into a License and Collaboration Agreement with CORXEL Pharmaceuticals (formerly known as Ji Xing Pharmaceuticals Hong Kong Limited) (“CORXEL”) granting CORXEL an exclusive license (the “CORXEL License” formerly referred to as the “Ji Xing License”) to certain of our intellectual property rights to develop, use, import, and sell products containing LNZ100 (“Products”) for use in the treatment of presbyopia in humans in mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan (collectively, “Greater China”). We also granted CORXEL (i) the right to negotiate in good faith and enter into agreements to purchase Products from us for clinical and commercial uses at cost plus a negotiated percentage and (ii) the right of first negotiation to obtain a regional license from us on other products we might develop outside of the field of presbyopia for commercialization in Greater China. We received nonrefundable, non-creditable upfront payments totaling $15.0 million as initial consideration under the CORXEL License during the year ended December 31, 2022. In addition, we received $5.0 million upon submission of the NDA for LNZ100 to the National Medical Products Administration (“NMPA”) in Greater China for the treatment of presbyopia and another $5.0 million upon FDA approval of VIZZ during the three months ended September 30, 2025. We are also eligible to receive (i) up to an additional $85.0 million in regulatory and sales milestone payments, (ii) tiered, escalating royalties in the range of 5% to 15% on net sales of Products in Greater China by CORXEL, its affiliates and sublicensees, and (iii) tiered, deescalating royalties in the range of 15% to 5% of sublicensing income received by CORXEL prior to the regulatory approval of the first Product in Greater China. The $15.0 million upfront payments allocated to that single performance obligation was recognized on execution of the CORXEL License during the year ended December 31, 2022. During the three months ended September 30, 2025, the first regulatory milestone under the CORXEL License was achieved upon submission of the NDA for LNZ100 to the NMPA. A second regulatory milestone under the CORXEL License was achieved upon FDA approval of VIZZ. We recognized revenue and received payment totaling $10.0 million for the achievement of both regulatory milestones during the three months ended September 30, 2025. No other contractual milestones were met under the CORXEL License during the three and nine months ended September 30, 2025 or 2024. On October 27, 2024, CORXEL and the Company announced positive topline data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. In this China Phase 3 safety and efficacy trial, LNZ100 achieved the primary endpoint and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (“BCDVA”) at near, without losing one-line or more in distance visual acuity. 25 Table of Contents Lotus Pharmaceutical Co., LTD. License and Commercialization Agreement On May 7, 2025, we entered into a license and commercialization agreement providing an exclusive license (the “Lotus License”) to certain of our IP to commercialize LNZ100 for the treatment of presbyopia in humans in the Republic of Korea, the Kingdom of Thailand, Republic of the Philippines, the Socialist Republic of Vietnam, Malaysia, Negara Brunei Darussalam, the Republic of Indonesia, and the Republic of Singapore (collectively, “Southeast Asia”). Under the terms of the Lotus License, we received a $5.0 million nonrefundable, non-creditable upfront payment, and are eligible to receive up to $120.0 million of regulatory and commercial milestone payments, as well as tiered, double-digit royalties on future net sales in Southeast Asia. Laboratoires Théa License and Commercialization Agreement On July 7, 2025, we entered into a license and commercialization agreement providing an exclusive license (the “Théa License”) to register and commercialize LNZ100 for the treatment of presbyopia in Canada. Under the terms of the Théa License, we received a $2.5 million nonrefundable, non-creditable upfront payment, and are eligible to receive up to $67.5 million in regulatory and commercial milestone payments, as well as tiered, double-digit royalties on future net sales in Canada. Key Trends and Factors Affecting Comparability Between Periods • License revenue increased during the three and nine months ended September 30, 2025 relative to the three and nine months ended September 30, 2024 as a result of upfront payments received under the Lotus and Théa Licenses, as well as the achievement of two regulatory milestones under the CORXEL License. We may generate future revenue from additional license and collaboration agreements to commercialize VIZZ outside the U.S. We have not recorded any product sales revenue for the periods presented. • We expect that selling, general and administrative expenses will continue to increase in 2025, relative to 2024, as we have built a cross-functional commercial team consisting of marketing, commercial operations and an 88-territory sales force, and will continue to strategically support our sales and commercial infrastructure with capabilities designed to scale when necessary to support the commercial launch of VIZZ. These expenses increased during the three and nine months ended September 30, 2025, as compared to the three and nine months ended September 30, 2024, and we expect such expenses to continue to increase for the foreseeable future. • Our research and development costs decreased during the three months ended September 30, 2025, relative to the comparative period in 2024 primarily due to FDA approval of VIZZ during the three months ended September 30, 2025. On a prospective basis subsequent to FDA approval on July 31, 2025, certain expenses that were historically classified as research and development expenses were and will be prospectively classified into sales, general and administrative expenses, including certain medical affairs and chemistry, manufacturing and controls expenses that indirectly support VIZZ. In addition, our research and development costs decreased during the nine months ended September 30, 2025, relative to the nine months ended September 30, 2024, primarily as a result of reduced clinical research expenses related to the substantial completion of our Phase 3 CLARITY trials in March 2024 and the prospective classifications noted above. We expect our research and development costs will continue to decrease over the remainder of 2025, relative to 2024, given the completion of the CLARITY trials, the subsequent reduction of clinical activities over 2024 and the FDA approval of VIZZ. Recent Developments FDA Approval and Commercial Launch of VIZZ On July 31, 2025, the FDA approved VIZZ, the first and only aceclidine-based product approved by the FDA. VIZZ has five years of NCE exclusivity in the United States, expiring in July 2030. We commercially launched VIZZ in the U.S. in August 2025, with direct-to-eye care professional sales and marketing activities initiated immediately upon approval. Professional product sample distribution by the sales force to optometrists and ophthalmologists and commercial product shipments to customers via our e-pharmacy partner were initiated in October 2025, and we anticipate product will be broadly available in retail pharmacies in the middle of the fourth quarter of 2025. CORXEL New Drug Application Submission In July 2025, a regulatory milestone was achieved upon the submission of the NDA for LNZ100 to the NMPA in Greater China for the treatment of presbyopia. 26 Table of Contents Basis of Presentation The following discussion highlights our results of operations and the principal factors that have affected our financial condition as well as our liquidity and capital resources for the periods described and provides information that management believes is relevant for an assessment and understanding of the unaudited condensed consolidated balance sheets and statements of operations and comprehensive loss presented herein. The following discussion and analysis are based on our unaudited condensed consolidated financial statements and related notes thereto, which we have prepared in accordance with U.S. GAAP. You should read the discussion and analysis together with such unaudited condensed consolidated financial statements and the related notes thereto. Components of Statements of Operations and Comprehensive Loss Revenue We have not generated any revenue from product sales through September 30, 2025, however, we expect to generate revenue from sales of VIZZ beginning in the fourth quarter of 2025. We have generated revenue related to various license and collaboration agreements, and in the future may generate revenue from payments received under additional licenses or collaboration agreements we may enter into with respect to VIZZ. Operating Expenses Selling, General and Administrative Selling, general and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, related to our executive, finance, business development, sales and marketing, human resources and other corporate functions. Other selling, general and administrative expenses include marketing, and advertising costs to support our 88-territory sales force, professional fees for legal, tax and business consulting services, public company related expenses such as audit fees and insurance costs, intellectual property and patent costs, facility costs and travel costs. Subsequent to the FDA approval of VIZZ, selling, general and administrative expenses also include salaries and related benefits and stock-based compensation costs related to our quality assurance, regulatory, supply chain and operations, and medical affairs functions. Research and Development Research and development expenses, which consist primarily of costs associated with our product research and development efforts, are expensed as incurred. Research and development expenses consist primarily of: (i) employee related costs, including salaries, benefits and share-based compensation expense for employees engaged in research and development activities; (ii) third-party contract costs relating to research, formulation, manufacturing, nonclinical studies and clinical trial activities; (iii) external costs of outside consultants who assist with technology development, regulatory affairs, clinical development and quality assurance prior to FDA approval; and (iv) allocated facility-related costs. Costs for certain activities, such as nonclinical studies and clinical trials are generally recognized based on the evaluation of the progress of completion of specific tasks using information and data provided by our vendors and collaborators. Other Income, Net Other income, net consists of interest income earned on cash, cash equivalents, and short-term investments, changes in the fair value of long-term investments due to observable price changes in orderly transactions for an identical or similar investment, and the change in fair value of preferred stock warrants liability. Upon completion of the Merger, the preferred stock warrants became exercisable into shares of common stock and will no longer continue to be remeasured at each reporting date. Results of Operations 27 Table of Contents Comparison of the Three Months Ended September 30, 2025 and 2024 The following table presents the results of operations for the periods indicated (amounts in thousands, except percentages): Three Months Ended September 30, 2025 2024 $ Change % Change License revenue $ 12,500 $ — $ 12,500 N/A Selling, general and administrative expenses 27,596 6,494 21,102 325 % Research and development expenses 3,791 6,451 (2,660) (41) % Other income, net 2,187 2,730 (543) (20) % License Revenue License revenue increased during the three months ended September 30, 2025 due to revenue recognized from the upfront payment under the Théa License and the achievement of two regulatory milestones under the CORXEL License. There was no license revenue in the three months ended September 30, 2024. Selling, General and Administrative Selling, general and administrative expenses increased $21.1 million, or 325%, to $27.6 million for the three months ended September 30, 2025 compared to $6.5 million for the three months ended September 30, 2024. The change was primarily driven by increases of $12.2 million in employee salaries and related expenses due to a rise in headcount, including the hiring of our 88-territory sales force, $4.9 million in pre-commercial and commercial marketing, advertising and sales infrastructure expenses as we prepared for and subsequently executed the commercial launch of VIZZ, $1.1 million in chemistry and control and regulatory related expenses which were classified as selling, general and administrative expenses subsequent to FDA approval, $1.1 million in travel related costs primarily related to our sales force, $0.9 million in other corporate overhead and $0.6 million in legal costs. Research and Development Research and development expenses incurred for the three months ended September 30, 2025 were primarily driven by pre-approval and contingent product manufacturing activities to support the commercial launch of VIZZ, which were recorded in research and development prior to FDA approval on July 31, 2025, while research and development expenses incurred for the three months ended September 30, 2024 were primarily incurred to further refine the manufacturing process for VIZZ. Research and development expenses decreased by $2.7 million, or 41%, to $3.8 million for the three months ended September 30, 2025 compared to $6.5 million for the three months ended September 30, 2024. Subsequent to FDA approval, people-related, chemistry and control, and regulatory costs previously classified as research and development expenses were prospectively classified as selling, general and administrative expenses, resulting in period over period decreases in research and development expenses of $1.3 million, $0.9 million, and $0.8 million, respectively. The reduction in research and development expenses were partially offset by a $0.6 million increase in contingent product manufacturing costs incurred prior to FDA approval. Prior to FDA approval of VIZZ on July 31, 2025, costs related to the production of inventory were expensed in the period incurred within research and development expenses, resulting in zero cost inventory. Subsequent to FDA approval of VIZZ, direct and indirect manufacturing costs were capitalized to inventory. Other Income, net Other income, net for the three months ended September 30, 2025, was $2.2 million, compared to $2.7 million for the three months ended September 30, 2024. Interest income earned on our cash, cash equivalents, and marketable securities decreased period over period due to a lower balance of marketable securities and slightly less favorable interest rates. 28 Table of Contents Comparison of the Nine Months Ended September 30, 2025 and 2024 The following table presents the results of operations for the periods indicated (amounts in thousands, except percentages): Nine Months Ended September 30, 2025 2024 $ Change % Change License revenue $ 17,500 $ — $ 17,500 N/A Selling, general and administrative expenses 51,505 19,452 32,053 165 % Research and development expenses 18,670 23,933 (5,263) (22) % Other income, net 6,944 6,268 676 11 % License Revenue License revenue increased during the nine months ended September 30, 2025 due to revenue recognized from the upfront payments under the Lotus and Théa Licenses, and the achievement of two regulatory milestones under the CORXEL License. There was no license revenue in the nine months ended September 30, 2024. Selling, General and Administrative Selling, general and administrative expenses increased $32.1 million, or 165%, to $51.5 million for the nine months ended September 30, 2025 compared to $19.5 million for the nine months ended September 30, 2024. Increases in the comparative period included $19.1 million in employee salaries and related expenses due to a rise in headcount, including the hiring of our 88-territory sales force, $8.1 million in pre-commercial and commercial marketing, advertising and sales infrastructure as we prepared for and subsequently executed the commercial launch of VIZZ, $1.8 million in travel expenses primarily related to our sales force, $1.7 million in other corporate overhead, and $1.1 million in chemistry and control and regulatory related expenses which were classified as selling, general and administrative expenses subsequent to FDA approval. Research and Development Research and development expenses incurred for the nine months ended September 30, 2025 were primarily driven by pre-approval and contingent product manufacturing activities to support the commercial launch of VIZZ, while research and development expenses incurred for the nine months ended September 30, 2024 were primarily incurred to further refine the manufacturing process for VIZZ. Research and development expenses decreased $5.3 million, or 22%, to $18.7 million for the nine months ended September 30, 2025 compared to $23.9 million for the nine months ended September 30, 2024. The decrease was primarily driven by a $7.0 million decrease in clinical and nonclinical research expense for our clinical trials, and a $1.9 million decrease in contract regulatory consulting expenses associated with the prior period preparation and filing of our NDA for VIZZ. The decrease was partially offset by a $2.2 million increase in contingent product manufacturing costs incurred prior to FDA approval and a $1.2 million increase in employee salaries and related expenses due to increased non-clinical regulatory and CMC headcount. Other Income, net Other income, net for the nine months ended September 30, 2025, was $6.9 million, compared to $6.3 million for the nine months ended September 30, 2024. Interest income earned on our cash, cash equivalents, and marketable securities increased by $0.8 million as a result of an overall increase in cash on-hand in 2025 over the comparative period. During the nine months ended September 30, 2024, we recorded a $1.0 million charge due to an increase in the fair value of the preferred stock warrants liability, resulting in a non-recurring, non-cash charge at the close of the Merger, and $1.3 million in other income related to an increase in the fair value of the Company's equity investment without a readily determinable fair value. Liquidity and Capital Resources Sources of Liquidity As of September 30, 2025, we had $202.2 million of cash, cash equivalents and marketable securities. We have incurred net losses in each year since inception and as of September 30, 2025, we had an accumulated deficit of $191.2 million. Our net losses were $16.7 million and $10.2 million for the three months ended September 30, 2025 and 2024, respectively, and $46.2 million and $37.1 million for the nine months ended September 30, 2025 and 2024, respectively. These losses have 29 Table of Contents resulted principally from costs incurred in connection with research and development activities and selling, general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses as we begin commercialization of VIZZ, including costs related to product sales, marketing, manufacturing, and distribution. From inception through September 30, 2025, we received funding of $13.0 million from our initial seed financing, $47.0 million from the sale of Series A Convertible Preferred stock, $10.0 million from the sale of Series A-1 Convertible Preferred Stock, gross proceeds of $83.5 million from the sale of Series B Convertible Preferred stock, approximately $117.8 million in cash and cash equivalents from the Merger, approximately $53.5 million in gross cash proceeds from the March 2024 PIPE Financing, and $30.0 million in gross cash proceeds from the July 2024 PIPE Financing. On April 4, 2025, we entered into a sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”) under which we may offer and sell up to $150.0 million of shares of our common stock from time to time through an “at the market” offering program under which TD Cowen will act as sales agent. Under the Sales Agreement, we set the parameters for the sale of shares, including the number or dollar amount of shares to be issued, the time period during which sales are requested to be made, limitations on the number or dollar amount of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, TD Cowen may sell the shares by methods deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. We have no obligation to sell any shares under the Sales Agreement and may at any time suspend solicitation and offers under the Sales Agreement. The shares will be issued pursuant to our shelf registration statement on Form S-3, including the prospectus supplement contained therein, which was declared effective by the SEC on April 14, 2025. There were no transactions executed under the Sales Agreement during the three months ended September 30, 2025. During the nine months ended September 30, 2025 , the Company sold an aggregate of 920,500 shares of common stock at a weighted-average price of $28.75 under the Sales Agreement, resulting in net proceeds of $26.1 million . As of September 30, 2025, the Company had $123.5 million of capacity remaining under the Sales Agreement. In October 2025, the Company sold an aggregate of 2,698,134 shares of common stock at a weighted-average price of $45.79 under the Sales Agreement, utilizing the remaining capacity under the Sales Agreement. Funding Requirements We believe that our cash, cash equivalents, and marketable securities as of September 30, 2025 will allow us to continue to build infrastructure and commercialize VIZZ, and such funds are anticipated to fund the Company to positive operating cash flow. This belief is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than expected. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than currently anticipated, and we may need to seek additional funds sooner than planned. Our future capital requirements will depend on many factors, including but not limited to: • costs associated with maintaining and expanding a sales, marketing, and distribution infrastructure to commercialize VIZZ; • our ability to generate positive operating cash flow from sales of VIZZ; • the costs of commercial manufacturing of VIZZ; • the costs, timing, and outcome of any additional regulatory review of VIZZ; • the legal costs of obtaining, maintaining, and enforcing our patents and other intellectual property rights; • our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company; • the terms and timing of establishing and maintaining licenses and other similar arrangements; • our ability to achieve sufficient market acceptance and adequate market share and revenue for VIZZ; and • costs associated with any products or technologies that we may in-license or otherwise acquire or develop. We intend to evaluate financing opportunities from time to time, and our ability to obtain financing will depend, among other things, on our development efforts, business plans, operating performance and the condition of the capital markets at the time we seek financing. We cannot be assured that additional financing will be available to us on favorable terms when 30 Table of Contents required, or at all. If we raise additional funds through the issuance of equity or equity-linked securities, those securities may have rights, preferences or privileges senior to the rights of our common stock, and our stockholders may experience dilution. If we raise additional funds through the incurrence of indebtedness, then we may be subject to increased fixed payment obligations and could be subject to restrictive covenants, such as limitations on our ability to incur additional debt, and other operating restrictions that could adversely impact our ability to conduct our business. Cash Flows The following table summarizes our cash flows for the periods presented (amounts in thousands): Nine Months Ended September 30, 2025 2024 Net cash (used in) provided by: Operating activities $ (36,145) $ (50,313) Investing activities 14,142 (142,616) Financing activities 27,130 198,949 Net increase in cash and cash equivalents $ 5,127 $ 6,020 Net Cash Used in Operating Activities Net cash used in operating activities primarily results from net loss adjusted for non-cash expenses, changes in working capital components, amounts due to contract research organizations to conduct our clinical programs, manufacturing of drug product and employee-related expenditures for research and development and selling, general and administrative activities. Cash flows from operating activities will continue to be impacted by the commercial launch of VIZZ, and will also be impacted by any potential future revenue from commercialization activities and licensing arrangements. Cash flows will also continue to be affected by other operating and general administrative activities, including operating as a public company. For the nine months ended September 30, 2025, cash used in operating activities was $36.1 million and resulted from a net loss of $46.2 million, offset by $6.3 million in non-cash adjustments primarily driven by share-based compensation expense and a $3.8 million increase in operating assets. For the nine months ended September 30, 2024, cash used in operating activities was $50.3 million and resulted from a net loss of $37.1 million, in addition to an approximate $14.4 million cash outflow from the payment of accounts payable and accrued liabilities associated with the Merger and accrued clinical activities, offset by $3.2 million in non-cash adjustments primarily driven by share-based compensation expense and the change in the fair value of preferred warrants. Net Cash Provided by (Used in) Investing Activities Cash provided by investing activities for the nine months ended September 30, 2025 was $14.1 million, primarily due to $162.6 million in proceeds from maturities of marketable securities, and partially offset by $147.7 million of purchases of marketable securities and $0.8 million in purchases of property and equipment. Cash used in investing activities for the nine months ended September 30, 2024 was $142.6 million, primarily due to $195.3 million of purchases of marketable securities, and partially offset by $53.0 million in proceeds from maturities of marketable securities. Net Cash Provided by Financing Activities Cash provided by financing activities for the nine months ended September 30, 2025 was primarily driven by $26.1 million in net proceeds from common stock sold under the Sales Agreement and $0.8 million in proceeds from exercises of stock options. For the nine months ended September 30, 2024, cash provided by financing activities was $198.9 million and includes $117.8 million in cash and cash equivalents acquired in the Merger, $53.5 million in gross cash proceeds from the March 2024 PIPE Financing, $30.0 million in gross cash proceeds from the July 2024 PIPE Financing, and approximately $3.9 million in net cash proceeds from exercises of stock options. 31 Table of Contents Material Cash Requirements from Contractual Obligations In February 2022, we entered into a lease for 2,930 square feet of office space in Del Mar, California. In March 2023, we entered into a lease amendment for a 647 square feet expansion of our office space at the same facility. The term of the lease, as amended, is forty-eight months from the original commencement date, terminating March 31, 2026, unless terminated sooner. In April 2024, we entered into a lease for 9,795 square feet of office space in Solana Beach, California. The term of the lease is thirty-nine months from the commencement date of July 1, 2024, ending September 30, 2027. See Note 6 to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for further details related to our office leases. We also have contracts with various suppliers and manufacturing companies to supply the active pharmaceutical ingredient used in VIZZ, and manufacture the drug product used in the regulatory process and clinical trials. The scope of the services under these contracts can be modified and the contracts cancelled by us upon written notice. In the event of a cancellation, the company would be liable for the cost and expenses incurred to date as well as any close out costs of the service arrangement. Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements as defined in the rules and regulations of the SEC. Critical Accounting Policies and Estimates Our management’s discussion and analysis of the financial condition and results of operations is based on our consolidated financial statements included in this Quarterly Report on Form 10-Q, which have been prepared in accordance with U.S. GAAP. The preparation of our condensed consolidated financial statements requires us to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities as of the date of the consolidated financial statements, as well as the reported amounts of expenses during the periods presented. We believe that the estimates, judgments and assumptions are reasonable based upon information available to us at the time that these estimates, judgments and assumptions are made. To the extent there are material differences between these estimates, judgments or assumptions and actual results, our consolidated financial statements will be affected. Historically, revisions to our estimates have not resulted in a material change to our condensed consolidated financial statements. While our significant accounting policies are described in more detail in the notes to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, we believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our condensed consolidated financial statements. Stock-Based Compensation Expense Stock-based compensation expense represents the cost of the grant date fair value of equity awards recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. We estimate the fair value of equity awards using the Black-Scholes option pricing model and recognize forfeitures as they occur. Estimating the fair value of equity awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is affected by assumptions regarding a number of variables, including the risk-free interest rate, the expected stock price volatility, the expected term of stock options, the expected dividend yield and the fair value of the underlying common stock on the date of grant. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. We determine the inputs and assumptions to the Black-Scholes option pricing model in the following manner: Fair Value of Common Stock —The fair market value of our common stock is based on its closing price as reported on the date of grant on the primary stock exchange on which our common stock is traded, adjusted for special dividends, if any. Expected Term —The Company uses the simplified method as prescribed by the Securities and Exchange Commission Staff Accounting Bulletin No. 107, Share-Based Payment , to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. Expected Volatility —Given our limited historical stock price volatility data, we derived the expected volatility from the average historical volatilities over a period approximately equal to the expected term of comparable publicly traded companies within our peer group that were deemed to be representative of future stock price trends as we have limited trading history for our common stock. We will continue to apply this process until a sufficient amount of historical information regarding the volatility of our own stock price becomes available. 32 Table of Contents Risk-Free Interest Rate —The risk-free interest rate is based on a United States Treasury instrument whose term is consistent with the expected term of the stock options. Expected Dividend Yield —The expected dividend yield is based on the Company’s historical and expected dividend payouts. The Company has historically paid no dividends, other than the special dividend paid by Graphite immediately prior to the close of the Merger, and does not anticipate dividends to be paid in the future. Other Company Information Jumpstart Our Business Startups Act ( “ JOBS Act ” ) We are an emerging growth company, as defined in the JOBS Act, and we may remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the initial public offering of Graphite’s common stock (i.e., December 31, 2026). For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company disclosure and reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. Accordingly, the information we disclose in our SEC filings may not be comparable with the information stockholders receive from other public companies in which they may hold stock. Additionally, under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. Prior to the Merger, Graphite elected to use, and we intend to continue to use, this extended transition period for complying with certain or new or revised accounting standards until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the closing of Graphite's initial public offering (i.e., December 31, 2026), (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period, or (iii) if we affirmatively and irrevocably opt out of the extended transition period provided by the JOBS Act. We are also a “smaller reporting company” because the market value of our stock held by non-affiliates was less than $700 million as of June 30, 2025 and the Company's annual revenue was less than $100 million during the fiscal year ended December 31, 2024. We may continue to be a smaller reporting company in any given year if either (i) the market value of our stock held by non-affiliates is less than $250 million as of the last day of the most recently completed second quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million as of the last day of the most recently completed second quarter. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. Recent Accounting Pronouncements See Note 2 to our condensed consolidated financial statements in this Quarterly Report on Form 10-Q for a discussion of recent accounting pronouncements. Item 3. Quantitative and Qualitative Disclosures About Market Risk We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and are not required to provide the information required under this item.