25 unchanged sentences
• expand our facilities.
−Removed: We recently began our clinical trial for CTIM-76 and no clinical studies have begun on CT-95 or CT-202.
+Added: We recently began our clinical trial for CTIM-76 and CT-95 and no clinical studies have begun on CT-202.
It will be several years, if ever, before we obtain regulatory approval for a therapeutic product candidate, at which time any revenues for such product candidate will depend upon many factors, including market conditions, costs and effectiveness of manufacturing, sales, marketing and distribution operations related to such product candidate, the scope of intellectual property protection for such product candidate, and the terms of any collaboration or other strategic arrangement we may have with respect to such product candidate and levels of reimbursement from third-party payors.
−Removed: If we are unable to develop and commercialize one or more product candidates either alone or with collaborators, including through the potential out-licensing of our product candidates, or if revenues from any product candidate that receives marketing approval or is commercialized are insufficient, we may not achieve profitability or sustain profitability, which would have an adverse effect on the value of our common stock, which would be materially adversely affected.
+Added: If we are unable to develop and commercialize one or more product candidates either alone or with collaborators, including through the potential out-licensing of our product candidates, or if revenues from any product candidate that receives marketing approval or is commercialized are insufficient, we may not achieve profitability or sustain profitability, which would have an adverse effect on the value of our common stock.
We will need to raise additional funding, which may not be available on acceptable terms, or at all.
21 unchanged sentences
Adequate additional financing may not be available to us on acceptable terms, or at all.
−Removed: If we are unable to obtain sufficient funding on a timely basis or on favorable terms, we may be required to significantly delay, reduce or eliminate one or more of our research or product development programs and/or commercialization efforts or we might have to obtain funds through arrangements, such as out-licensing our product candidates, with collaborative partners or others that may require us to relinquish rights to our technologies or product candidates that we otherwise would not relinquish.
+Added: If we are unable to obtain sufficient funding on a timely basis or on favorable terms, we may be required to significantly delay, reduce or eliminate one or more of our research or product development programs and/or commercialization efforts or we might have to obtain funds through arrangements, such as selling or out-licensing our product candidates, with collaborative partners or others that may require us to relinquish rights to our technologies or product candidates that we otherwise would not relinquish.
We may also be unable to expand our operations or otherwise capitalize on business opportunities as desired.
1 unchanged sentence
If we are not able to successfully integrate recent and future acquisitions, our management’s attention could be diverted, and efforts to integrate future acquisitions could consume significant resources.
−Removed: Our recent obtainment of the rights to CT-202 and the acquisition of CT-95, and any other future acquisition that we may undertake, involve risks related to the integration of the acquired assets into the Company after the acquisition is completed.
+Added: Our obtainment of the rights to CT-202 and the acquisition of CT-95, and any other future acquisition that we may undertake, involve risks related to the integration of the acquired assets into the Company after the acquisition is completed.
These risks include delays in development timelines, increased expenses, and assumption of undisclosed liabilities.
5 unchanged sentences
Our product candidates and the therapeutic approach we are using are new and unproven.
−Removed: We had commenced Phase 2 human clinical trials for ONA-XR, but we ceased development of this product candidate and have only recently initiated clinical trials for one of our other product candidates, and we have not demonstrated an ability to successfully complete any clinical trials, obtain any required marketing approvals, manufacture products, conduct sales, marketing and distribution activities, or arrange for a third party to do any of the foregoing on our behalf.
+Added: We have not demonstrated an ability to successfully complete any clinical trials, obtain any required marketing approvals, manufacture products, conduct sales, marketing and distribution activities, or arrange for a third party to do any of the foregoing on our behalf.
Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing products.
9 unchanged sentences
dollar could increase our operating expenses, which would adversely impact our results of operations and financial position.
−Removed: Inflation could adversely affect our business and results of operations.
−Removed: While inflation in the United States has been relatively low in recent years, the economy in the United States has encountered a material level of inflation since 2021.
−Removed: Although inflation eased somewhat in 2024, it has raised our costs for commodities, labor, materials, and services and other costs required to grow and operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition.
−Removed: Additionally, increases in inflation, along with public health concerns, geopolitical developments, and global supply chain disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment, which may make it more difficult, costly, or dilutive for us to secure additional financing.
+Added: Inflation, geopolitical developments, global supply chain disruptions and public health concerns could adversely affect our business and results of operations.
+Added: While inflation in the United States has been relatively low in recent years, the economy in the United States has encountered a higher level of inflation since 2021.
+Added: Inflation has raised our costs for commodities, labor, materials, and services and other costs required to grow and operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition.
+Added: Additionally, increases in inflation, along with geopolitical developments, global supply chain disruptions and public health concerns, have caused, and may in the future cause, global economic uncertainty and instability, which may make it more difficult or costly for us to secure additional financing or acquire the supplies necessary to run our clinical trials.
A failure to adequately respond to these risks could have a material adverse impact on our financial condition, results of operations, or cash flows.
+Added: Changes in U.S.
+Added: trade policy, including the imposition of tariffs and the resulting consequences, may have a material adverse impact on our business, financial condition, and results of operations.
+Added: government has adopted new approaches to trade policy, and in some cases may renegotiate, or potentially terminate, certain existing bilateral or multi-lateral trade agreements.
+Added: government has also imposed tariffs on most foreign goods and has threatened to impose significant tariff increases or expand the tariffs to capture other countries and types of goods, including pharmaceutical products.
+Added: Tariffs on imports from nations from whom we procure raw materials used in the manufacturing process, clinical supplies or other required products are likely to increase the difficulty and cost of our research and development, and/or could require us to incur significant costs to transition to alternative suppliers.
+Added: Future tariff increases, expanding the tariffs to cover other countries or other changes in U.S.
+Added: trade policy could exacerbate these challenges.
+Added: Further increasing uncertainty related to trade policies, on February 20, 2026, the U.S.
+Added: Supreme Court ruled against the U.S.
+Added: presidential administration’s use of tariffs under the International Emergency Economic Powers Act ("IEEPA").
+Added: However, the decision creates uncertainty related to various aspects of the tariffs previously collected under the IEEPA, and not all tariffs announced throughout 2025 were impacted by this U.S.
+Added: Supreme Court decision.
+Added: Additionally, in response to the U.S.
+Added: Supreme Court ruling, the U.S.
+Added: presidential administration imposed a new worldwide tariff effective for 150 days from February 24, 2026.
+Added: The imposition of these new, worldwide tariffs, as well as the potential for further tariff actions by the U.S.
+Added: presidential administration or others, represents a significant source of uncertainty.
+Added: In addition, in response to these tariffs, other countries have threatened, announced or implemented retaliatory tariffs on U.S.
+Added: Political tensions and uncertainty as a result of rapidly changing trade policies could reduce trade volume, investment, technological exchange, and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets, which could in turn have a material adverse impact on our business, financial condition and results of operations.
Our governing documents designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of state law actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.
−Removed: Our amended and restated certificate of incorporation provides that, unless we consent in writing to the selection of an alternative form, the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the United States District Court for the District of Delaware) will be the sole and exclusive forum for:
+Added: Our amended and restated certificate of incorporation provides that, unless we consent in writing to the selection of an alternative form, the Court of Chancery of the State of Delaware (or, if the Court of Chancery does
+Added: not have jurisdiction, the United States District Court for the District of Delaware) will be the sole and exclusive forum for:
(1) any derivative action or proceeding brought on our behalf;
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While the scope of regulatory approval generally is similar in other countries, in order to obtain separate regulatory approval in other countries, we must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy.
−Removed: Other countries also have their own regulations governing, among other things, clinical trials and commercial sales, as well as pricing and distribution of our current and any future product candidates, and we may be required to expend significant resources to obtain regulatory approval and to comply with ongoing regulations in these jurisdictions.
+Added: Other countries also have their own regulations governing, among other things, clinical trials and commercial sales, as well as pricing and distribution of
+Added: our current and any future product candidates, and we may be required to expend significant resources to obtain regulatory approval and to comply with ongoing regulations in these jurisdictions.
The clinical and commercial success of our current and any future product candidates will depend on a number of factors, including the following:
6 unchanged sentences
• our ability to consistently provide for manufacturing of our product candidates or future approved products, if any, on a timely basis;
−Removed: • our ability, and the ability of any third parties with whom we contract, to remain in good standing with regulatory agencies and to develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices (“cGMPs”);
+Added: • our ability, and the ability of any third parties with whom we contract, to remain in good standing with regulatory agencies and to develop, validate and maintain commercially viable manufacturing processes that are compliant with cGMPs;
• our ability to demonstrate to the satisfaction of the FDA and similar foreign regulatory authorities the safety, efficacy and acceptable risk-benefit profile of our product candidates;
−Removed: • the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates or future approved products, if any;
+Added: • the prevalence, duration and severity of any side effects or other safety issues experienced with our product candidates or future approved products, including when tested or used in combination with other approved products or product candidates;
• the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;
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Accordingly, we cannot provide assurances that we will be able to generate sufficient revenue through the sale of our product candidates or any future product candidates to continue our business or achieve profitability.
−Removed: Our innovative therapy approach is based on novel ideas and technologies that are unproven and may not result in marketable products, which exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval.
−Removed: Our foundational science and product development approach are based on the selective targeting of solid-tumor cancers to elicit meaningful anticancer activity.
−Removed: We believe that this approach may offer an improved therapeutic effect by redirecting T-cell-mediated lysis toward malignant cells expressing the tumor antigens that are targeted (CLDN6, MSLN or Nectin-4).
−Removed: However, this approach to treating cancer is novel and the scientific research that forms the basis of our efforts to develop therapeutics that effectively inhibit membrane protein targets is both preliminary and limited.
−Removed: As such, we cannot assure you that even if we are able to develop cancer therapeutic candidates capable of redirecting T-cell-mediated lysis toward malignant cells, that such therapy would safely and effectively treat cancers.
−Removed: We may spend substantial funds attempting to develop this approach and never succeed in developing a marketable therapeutic.
−Removed: Furthermore, no regulatory authority has granted approval for a T cell redirecting cancer therapy based on a selective targeting of CLDN6, MSLN or Nectin-4 positive cancers.
−Removed: As such, we believe the FDA has limited experience with evaluating our approach, which may increase the complexity, uncertainty and length of the regulatory approval process for our product candidates.
−Removed: We may never receive approval to market and commercialize any product candidate.
−Removed: Even if we obtain regulatory approval, the approval may be for targets, disease indications, lines of therapy or patient populations that are not as broad as we intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings.
Results of preclinical studies, early clinical trials or analyses may not be indicative of results obtained in later trials.
10 unchanged sentences
Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.
−Removed: Any product candidate may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require it to be taken off the market, require it to include safety warnings or otherwise limit its sales.
−Removed: Serious adverse events or undesirable side effects caused by a product candidate could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities.
+Added: Any product candidate, whether used alone or in combination with other approved products or product candidates, may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require it to be taken off the market, require it to include safety warnings or otherwise limit its sales.
+Added: Serious adverse events or undesirable side effects caused by a product candidate, whether used alone or in combination with other approved products or product candidates, could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities.
Results of any clinical trial we conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.
−Removed: For example, certain patients treated with ONA-XR, our former product candidate, experienced adverse events that included, but were not limited to, fatigue, liver enzyme elevations and nausea.
−Removed: If unacceptable side effects arise in the development of any product candidate, we, the FDA or the institutional review boards (“IRBs”) at the institutions in which our studies are conducted, or the data safety monitoring board, if constituted for our clinical trials, could recommend a suspension or termination of our clinical trials, or the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications.
+Added: For example, certain patients treated with CTIM-76 or CT-95 experienced adverse events that included, but were not limited to, cytokine release syndrome, fatigue, liver enzyme elevations and nausea.
+Added: If unacceptable side effects arise in the development of any product candidate, we, the FDA or comparable foreign regulatory authorities, the institutional review boards (“IRBs”) at the institutions in which our studies are conducted, or the data safety monitoring board, if constituted for our clinical trials, could recommend a suspension or termination of our clinical trials, or the FDA or comparable foreign regulatory authorities could order us to cease
+Added: further development of or deny approval of a product candidate for any or all targeted indications.
In addition, drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete a trial or result in potential product liability claims.
In addition, these side effects may not be appropriately recognized or managed by the treating medical staff.
−Removed: We expect to have to train medical personnel using a product candidate to understand the side effect profiles for our clinical
−Removed: trials and upon any commercialization of any product candidate.
−Removed: Inadequate training in recognizing or managing the potential side effects of any product candidate could result in patient injury or death.
+Added: We expect to have to train medical personnel using a product candidate, whether used alone or in combination with other approved products or product candidates, to understand the side effect profiles for our clinical trials and upon any commercialization of any product candidate.
+Added: Inadequate training in recognizing or managing the potential side effects of any product candidate, whether used alone or in combination with other approved products or product candidates, could result in patient injury or death.
Any of these occurrences may harm our business, financial condition and prospects significantly.
−Removed: Additionally, if any product candidate receives marketing approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result, including:
+Added: Additionally, if any product candidate receives marketing approval, and we or others later identify undesirable side effects caused by such product, whether used alone or in combination with other approved products or product candidates, a number of potentially significant negative consequences could result, including:
• regulatory authorities may withdraw approvals of such product;
17 unchanged sentences
The timing of our clinical trials depends, in part, on the speed at which we can recruit patients to participate in our trials, as well as completion of required follow-up periods.
−Removed: The eligibility criteria of our clinical trials, once established, may further limit the pool of available trial participants.
+Added: eligibility criteria of our clinical trials, once established, may further limit the pool of available trial participants.
If patients are unwilling or unable to participate in our trials for any reason, including the existence of concurrent clinical trials for similar target populations, the availability of approved or authorized therapies, or the fact that enrolling in our trials may prevent patients from taking a different product, or we otherwise have difficulty enrolling a sufficient number of patients, the timeline for recruiting patients, conducting trials, and obtaining regulatory approval of our product candidates may be delayed.
−Removed: Our inability to enroll a specified number of patients for any of
−Removed: our future clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.
−Removed: We cannot assure you that our assumptions used in determining expected clinical trial timelines are correct or that we will not experience delays or difficulties in enrollment, or be required by the FDA or other regulatory authorities to increase our enrollment, which would result in the delay of completion of such trials beyond our expected timelines.
+Added: Our inability to enroll a specified number of patients for any of our future clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.
+Added: We cannot assure you that our assumptions used in determining expected clinical trial timelines are correct or that we will not experience delays or difficulties in enrollment, or be required by the FDA or similar regulatory authorities outside the United States to increase our enrollment, which would result in the delay of completion of such trials beyond our expected timelines.
The success of our business depends primarily upon our ability to identify, develop and commercialize products using our proprietary technologies.
−Removed: We recently initiated clinical trials for CTIM-76, anticipate dosing the first patient in the CT-95 Phase 1 trial in the second quarter of 2025, and CT-202 is still in the IND validation process.
+Added: We have initiated Phase 1 clinical trials for CTIM-76 and CT-95 in 2025 and are planning for the initiation of a first-in-human trial for CT-202.
We may be unsuccessful in advancing any product candidate during clinical development or otherwise into clinical development or in identifying and developing additional product candidates.
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Even if we do commence additional clinical trials of product candidates and continue to identify new product candidates, such product candidates may never be approved.
−Removed: Failure to successfully identify and develop new product candidates and obtain regulatory approvals for our products would have a material adverse effect on our business and financial condition and could cause us to cease operations.
+Added: Failure to successfully identify and develop new product candidates and obtain regulatory approvals for our product candidates would have a material adverse effect on our business and financial condition and could cause us to cease operations.
+Added: Our innovative therapy approach is based on novel ideas and technologies that are unproven and may not result in marketable products, which exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval.
+Added: Our foundational science and product development approach are based on the selective targeting of solid-tumor cancers to elicit meaningful anticancer activity.
+Added: We believe that this approach may offer an improved therapeutic effect by redirecting T-cell-mediated lysis toward malignant cells expressing the tumor antigens that are targeted (CLDN6, MSLN or Nectin-4).
+Added: However, this approach to treating cancer is novel and the scientific research that forms the basis of our efforts to develop therapeutics that effectively inhibit membrane protein targets is both preliminary and limited.
+Added: As such, we cannot assure you that even if we are able to develop cancer therapeutic candidates capable of redirecting T-cell-mediated lysis toward malignant cells, that such therapy would safely and effectively treat cancers.
+Added: We may spend substantial funds attempting to develop this approach and never succeed in developing a marketable therapeutic.
+Added: Furthermore, no regulatory authority has granted approval for a T cell redirecting cancer therapy based on a selective targeting of CLDN6, MSLN or Nectin-4 positive cancers.
+Added: As such, we believe the FDA has limited experience with evaluating our approach, which may increase the complexity, uncertainty and length of the regulatory approval process for our product candidates.
+Added: We may never receive approval to market and commercialize any product candidate.
+Added: Even if we obtain regulatory approval, the approval may be for targets, disease indications, lines of therapy or patient populations that are not as broad as we intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings.
If a product candidate does not achieve projected development milestones or commercialization in the announced or expected timeframes, the further development or commercialization of such product candidate may be delayed, and our business will be harmed.
−Removed: We sometimes estimate, or may in the future estimate, the timing of the accomplishment of various scientific, clinical, manufacturing, regulatory and other product development objectives.
+Added: We sometimes estimate, and may in the future estimate, the timing of the accomplishment of various scientific, clinical, manufacturing, regulatory and other product development objectives.
These milestones may include our expectations regarding the commencement or completion of scientific studies or clinical trials, the submission of regulatory filings, the receipt of marketing approval or the realization of other commercialization objectives.
1 unchanged sentence
All of these milestones are based on a variety of assumptions, including assumptions regarding capital resources, constraints and priorities, progress of and results from development activities and the receipt of key regulatory approvals or actions, any of which may cause the timing of achievement of the milestones to vary considerably from our estimates.
−Removed: For example, in 2024 we adjusted our guidance regarding the anticipated dosing of the first patient in the CTIM-76 Phase 1 trial.
+Added: For example, in 2025 we adjusted our guidance regarding the anticipated dosing of the first patient in the CT-95 Phase 1 trial.
If we or our collaborators fail to achieve announced milestones in the expected timeframes, the commercialization of the affected product candidate may be delayed, our credibility may be undermined, our business and results of operations may be harmed, and the price of our common stock may decline.
9 unchanged sentences
Clinical development does not always fully characterize the safety and efficacy profile of a new medicine, and it is always possible that a drug or biologic, even after regulatory approval, may exhibit unforeseen side effects.
−Removed: If any product candidate were to cause adverse side effects during clinical trials or after approval, we may be exposed to substantial liabilities.
+Added: product candidate were to cause adverse side effects during clinical trials or after approval, we may be exposed to substantial liabilities.
Product liability insurance coverage may not be adequate to cover all liabilities that we may incur.
We anticipate that we will need to increase our insurance coverage when we expand our clinical trials and if we or our collaborators successfully commercialize any products.
+Added: We may be required by the FDA to obtain approval of a companion diagnostic in connection with approval of our current product candidates, and if we do not obtain, or face delays in obtaining, FDA approval of such companion diagnostic, we will not be able to commercialize such product candidate and our ability to generate revenue will be materially impaired.
+Added: According to FDA guidance, if the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic product or indication, the FDA generally will not approve the therapeutic product or new therapeutic product indication if the companion diagnostic is not also approved or cleared for that indication.
+Added: We have collaborated, and expect to continue to collaborate, with diagnostic companies during our clinical trial enrollment process to help identify patients with characteristics that we believe will be most likely to respond to our product candidates.
+Added: If a satisfactory companion diagnostic is not commercially available in this situation, we may be required to develop or obtain such diagnostic, which would be subject to regulatory approval requirements.
+Added: The process of obtaining or creating a diagnostic is time consuming and costly.
+Added: Companion diagnostics are developed in conjunction with clinical programs for the associated product candidate and are subject to regulation as medical devices by the FDA and comparable foreign regulatory authorities, and the FDA has generally required premarket approval of companion diagnostics for cancer therapies.
+Added: The approval or clearance of a companion diagnostic as part of the therapeutic product’s further labeling limits the use of the therapeutic product to only those patients who express the specific characteristic that the companion diagnostic was developed to detect.
+Added: We and/or third-party collaborators may encounter difficulties in developing and obtaining approval or clearance for companion diagnostics.
+Added: Any delay or failure by us or third-party collaborators to develop or obtain regulatory approval or clearance of a companion diagnostic could delay or prevent approval or continued marketing of the relevant product candidate.
+Added: We or our collaborators may also experience delays in developing a sustainable, reproducible and scalable manufacturing process for the companion diagnostic or in transferring that process to commercial partners or negotiating insurance reimbursement plans, all of which may prevent us from completing our clinical trials or commercializing our product candidates, if approved, on a timely or profitable basis, if at all.
+Added: Fast track designation from the FDA may not actually lead to a faster development or regulatory review or approval process.
+Added: Investigational biological product candidates are eligible for fast track designation if they are 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.
+Added: The sponsor of a fast track designated product candidate has opportunities for more frequent interactions with the applicable FDA review team during product candidate development.
+Added: Even if the FDA grants fast track designation to one of our product candidates, such designation may not result in a faster development process, review or approval compared to product candidates considered for approval under conventional FDA procedures, and the designation does not assure ultimate approval by the FDA.
+Added: In addition, the FDA may later decide that the product candidate no longer meets the conditions for qualification and rescind the designation.
+Added: We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
+Added: We may seek orphan drug designation in the U.S.
+Added: and in the European Union for our product candidates.
+Added: Upon receipt of FDA approval, orphan drug status would provide us with seven years of market exclusivity in the U.S.
+Added: under the Orphan Drug Act.
+Added: However, there is no guarantee that the FDA will grant orphan drug designation for any of our product candidates for any indication, which would make us ineligible for the additional exclusivity and other benefits of orphan drug designation.
+Added: Moreover, there can be no assurance that another company also holding orphan
+Added: drug designation for the same indication, or which may receive orphan drug designation in the future, will not receive approval prior to us, in which case our competitor would have the benefit of the seven years of market exclusivity, and we would be unable to commercialize our product for the same indication until the expiration of such seven-year period.
+Added: Even if we are the first to obtain approval for the orphan drug indication, there are circumstances under which a competing product may be approved for the same indication during our seven-year period of exclusivity.
+Added: Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the U.S.
+Added: and for which there is no reasonable expectation that the cost of developing and making a drug available in the U.S.
+Added: for this type of disease or condition will be recovered from sales of the product.
+Added: Orphan drug designation must be requested before submitting a marketing application.
+Added: After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA.
+Added: Orphan designation does not convey any advantage in or shorten the duration of regulatory review and approval process.
+Added: In addition to the potential period of exclusivity, orphan designation makes a company eligible for grant funding of up to $0.4 million per year for four years to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential exemption from the FDA application user fee.
+Added: There can be no assurance that we will receive orphan drug designation for any of our drug candidates for any additional indications if we elect to seek such designation.
+Added: Even if orphan designation is granted, it may be withdrawn by the FDA for non-compliance with regulations.
Risks Related to Our Organization, Structure and Operations
Our reliance on a central team consisting of a limited number of employees and consultants who provide various administrative, research and development, and other services across our organization presents operational challenges that may adversely affect our business.
−Removed: As of March 1, 2025, we had twelve full-time employees.
+Added: As of March 1, 2026, we had fifteen full-time employees.
We also have various consultants who we rely on for research and development, business development and other services.
3 unchanged sentences
We are highly dependent on the research and development experience, technical skills, leadership and continued service of certain members of our management and scientific teams, including Martin Lehr, our Chief Executive Officer, Dr.
−Removed: Claudio Dansky Ullmann, our Chief Medical Officer, Jennifer Minai-Azary, our Chief Financial Officer, and Alex Levit, our Chief Legal Officer.
+Added: Karen Chagin, our Chief Medical Officer, Jennifer Minai-Azary, our Chief Financial Officer, and Alex Levit, our Chief Legal Officer.
Although we have formal employment agreements with all of our executive officers, these agreements do not prevent them from terminating their employment with us at any time.
27 unchanged sentences
Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions, could adversely affect our current and projected business operations, financial condition and results of operations.
−Removed: Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems.
−Removed: For example, on March 10, 2023, Silicon Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (“FDIC”) as receiver.
−Removed: Subsequently, in March 2023, First Citizens BancShares acquired SVB.
−Removed: Inflation and rapid increases in interest rates have led to a decline in the trading value of previously issued government securities with interest rates below current market interest rates.
−Removed: Although the U.S.
−Removed: Department of Treasury, FDIC and Federal Reserve Board announced a program in March 2023 to provide up to $25 billion of loans to financial institutions secured by certain of such government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial institutions for immediate liquidity may exceed the capacity of such a program.
−Removed: Additionally, there is no guarantee that the U.S.
−Removed: Department of Treasury, FDIC and Federal Reserve Board will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions, or that they would do so in a timely fashion.
−Removed: In addition, a supplier or collaboration partner could be adversely affected by any of the liquidity risks that are described above.
+Added: Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems, which could adversely affect us and our suppliers and collaboration partners.
Any supplier or collaboration partner bankruptcy or insolvency, or the failure of any collaboration partner to make payments when due, or any breach or default by a supplier or collaboration partner, or the loss of any significant supplier or collaboration partner relationships, could result in material losses to us and may have a material adverse impact on our business.
11 unchanged sentences
These events could delay development programs and negatively impact the perception of our company in business and financial communities.
−Removed: Failure to develop or maintain relationships with any current collaborators could result in the loss of opportunity to work with that collaborator or reputational damage that could impact our relationships with other collaborators in the relatively small industry communities in which we operate.
+Added: Failure to develop or maintain relationships with any current collaborators
+Added: could result in the loss of opportunity to work with that collaborator or reputational damage that could impact our relationships with other collaborators in the relatively small industry communities in which we operate.
Moreover, all of the risks relating to product development, regulatory approval and commercialization described in this Form 10-K apply to the activities of our collaborators.
7 unchanged sentences
Further, any disagreements or disputes over our obligations or intellectual property that we have licensed or acquired may prevent or impair our ability to maintain our current arrangements on acceptable terms.
−Removed: If we fail to meet our obligations under these agreements or licenses, the respective counterparty may have the right to terminate the respective agreement or license and to re-obtain the related technology as well as aspects of any intellectual
−Removed: property controlled by us and developed during the period the agreement or license was in force that relates to the applicable technology.
+Added: If we fail to meet our obligations under these agreements or licenses, the respective counterparty may have the right to terminate the respective agreement or license and to re-obtain the related technology as well as aspects of any intellectual property controlled by us and developed during the period the agreement or license was in force that relates to the applicable technology.
While we would expect to exercise our rights and remedies available to us in the event we fail to meet our obligations under such agreement or license in any material respect and otherwise seek to preserve our rights under the technology licensed to or acquired by us, we may not be able to do so in a timely manner, at an acceptable cost or at all.
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For example, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial.
−Removed: Moreover, the FDA requires us to comply with regulations, commonly referred to as good clinical practices (“GCPs”), for conducting, monitoring, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.
+Added: Moreover, the FDA requires us to comply with regulations, commonly referred to as GCPs, for conducting, monitoring, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.
Although we have designed and intend to design future trials for product candidates either alone or with collaborators, third parties may conduct some parts of or all of the trials.
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If we are required to repeat, extend the duration of or increase the size of any trials we conduct, it could significantly delay commercialization and require significantly greater expenditures.
+Added: Further, conducting clinical trials in foreign countries, which we are pursuing for certain of our product candidates, presents additional risks that may delay completion of our clinical trials.
+Added: These risks include the failure of enrolled subjects in foreign countries to adhere to clinical protocols as a result of differences in healthcare services or cultural customs, failure to comply with privacy and related legal requirements, managing additional administrative burdens and costs associated with foreign regulatory schemes, managing cross-border operational activities, and political and economic risks relevant to such foreign countries.
As a result of any of these factors, our financial results and the commercial prospects for the affected product candidate would be harmed, our costs could increase and our ability to generate revenues could be delayed.
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We will make changes as we work to optimize the manufacturing process, and we cannot be sure that even minor changes in the process will result in products that are safe and effective.
−Removed: If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory
−Removed: requirements of the FDA or other regulatory authorities, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.
+Added: If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or other regulatory authorities, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.
In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel.
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We face significant competition in establishing relationships with appropriate collaborators.
−Removed: In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.
+Added: In addition, there continues to be consolidation among large pharmaceutical companies, which has resulted in a reduced number of potential future collaborators.
Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.
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The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support licensure.
+Added: The novel mechanism of action and immunotherapy characteristics of our TCE bsAb product candidates may present unique clinical safety risks, which could delay or prevent regulatory approval.
The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain licensure of product candidates based on the completed clinical trials, as the FDA often makes decisions consistent with the Advisory Committee’s recommendations.
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• addressing any patient safety concerns that arise during the course of a trial;
+Added: • the possibility that immune-mediated toxicities associated with our TCE bsAb produce candidates may require trial protocol modifications, dose interruptions or reductions, or could delay or prevent the completion of clinical trials;
• adding new clinical trial sites;
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In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.
+Added: In addition, because the product candidates utilize a TCE bsAb mechanism of action, clinical development may be particularly susceptible to immune-mediated adverse events, which may required protocol modifications, dose interruptions or reductions, enhanced patient monitoring, or hospitalization requirements, and could delay, suspend or prevent the completion of clinical trials.
Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial of regulatory approval of our current and any future product candidates.
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If and when our clinical trials for our current and any future product candidates are completed and, assuming positive data, we expect to advance to potential registrational trials.
−Removed: The general approach for FDA approval of a new biologic or drug is for the sponsor to provide dispositive data from two well-controlled, Phase 3 clinical studies of the relevant biologic or drug in the relevant patient population.
+Added: The current general approach for FDA approval of a new biologic or drug is for the sponsor to provide dispositive data from at least one well-controlled, Phase 3 clinical study of the relevant biologic or drug in the relevant patient population, although the FDA has historically required, and many foreign regulatory authorities still require, dispositive data from two such studies.
Phase 3 clinical studies typically involve hundreds of patients, have significant costs and take years to complete.
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As well, in 2022 the Oncology Center of Excellence (OCE) of the FDA implemented Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development, which has impacted and could continue to impact our current and future clinical trials and significantly delay our development timelines and require substantially more resources.
+Added: In addition, because our product candidates utilize a TCE bsAb mechanism of action, clinical development may be subject to risks associated with immune-mediated toxicities, which may require protocol modifications, dose interruptions or reductions, enhanced patient monitoring, or hospitalization and could delay or prevent regulatory approval.
The FDA may grant accelerated approval for a product candidate and, as a condition for accelerated approval, the FDA may require a sponsor of a drug or biologic receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug or biologic may be subject to withdrawal procedures by the FDA that are more accelerated than those available for regular approvals.
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• the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
−Removed: • the data collected from clinical trials of our current and any future product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
+Added: • the data collected from clinical trials of our current and any future product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a
+Added: BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
• the FDA or comparable foreign regulatory authorities will review our manufacturing process and inspect our commercial manufacturing facility and may not approve our manufacturing process or facility;
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If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our current and any future product candidates will be harmed.
−Removed: We will be subject to ongoing regulatory obligations and continued regulatory review, 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 a product candidate.
−Removed: Any regulatory approvals that we receive for a product candidate will require surveillance to monitor the safety and efficacy of the product candidate.
−Removed: The FDA may also require a REMS in order to approve a product candidate, 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.
−Removed: In addition, if the FDA or a comparable foreign regulatory authority approves a product candidate, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for that product candidate will be subject to extensive and ongoing regulatory requirements.
−Removed: These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval.
−Removed: As such, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any BLA, other marketing applications and previous responses to inspectional observations.
−Removed: Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.
−Removed: In addition, the FDA could require us to conduct another study to obtain additional safety or biomarker information.
−Removed: Further, we will be required to comply with FDA promotion and advertising rules, which include, among others,
−Removed: standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses (known as “off-label use”), limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet and social media.
−Removed: Later discovery of previously unknown problems with a product candidate, including adverse events of unanticipated severity or frequency, or with our third-party suppliers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information;
−Removed: imposition of post-market studies or clinical studies to assess new safety risks;
−Removed: or imposition of distribution restrictions or other restrictions under a risk evaluation and mitigation strategy program.
−Removed: Other potential consequences include, among other things:
−Removed: • restrictions on the marketing or manufacturing of a product candidate, withdrawal of the product from the market or voluntary or mandatory product recalls;
−Removed: • fines, warning letters or holds on clinical trials;
−Removed: • refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;
−Removed: • product seizure or detention, or refusal to permit the import or export of a product candidate;
−Removed: • injunctions or the imposition of civil or criminal penalties.
−Removed: 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 current and any future product candidates.
−Removed: We 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.
−Removed: 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 and we may not achieve or sustain profitability.
Even if we obtain regulatory approval of a product candidate, the product may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.
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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.
+Added: We will be subject to ongoing regulatory obligations and continued regulatory review, 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 a product candidate.
+Added: Any regulatory approvals that we receive for a product candidate will require surveillance to monitor the safety and efficacy of the product candidate.
+Added: The FDA may also require a REMS in order to approve a product candidate, 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.
+Added: In addition, if the FDA or a comparable foreign regulatory authority approves a product candidate, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for that product candidate will be subject to extensive and ongoing regulatory requirements.
+Added: These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval.
+Added: As such, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any BLA, other marketing applications and previous responses to inspectional observations.
+Added: Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.
+Added: In addition, the FDA could require us to conduct another study to obtain additional safety or biomarker information.
+Added: Further, we will be required to comply with FDA promotion and advertising rules, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses (known as “off-label use”), limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet and social media.
+Added: Later discovery of previously unknown problems with a product candidate, including adverse events of unanticipated severity or frequency, or with our third-party suppliers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information;
+Added: imposition of post-market studies or clinical studies to assess new safety risks;
+Added: or imposition of
+Added: distribution restrictions or other restrictions under a risk evaluation and mitigation strategy program.
+Added: Other potential consequences include, among other things:
+Added: • restrictions on the marketing or manufacturing of a product candidate, withdrawal of the product from the market or voluntary or mandatory product recalls;
+Added: • fines, warning letters or holds on clinical trials;
+Added: • refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;
+Added: • product seizure or detention, or refusal to permit the import or export of a product candidate;
+Added: • injunctions or the imposition of civil or criminal penalties.
+Added: 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 current and any future product candidates.
+Added: We 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.
+Added: 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 and we may not achieve or sustain profitability.
The advancement of healthcare reform may negatively impact our ability to sell our current and any future product candidates, if approved, profitably.
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In addition, other legislative changes have been proposed and adopted in the United States since PPACA was enacted which, among other things, have reduced Medicare payments to several types of providers, including hospitals and cancer treatment centers.
−Removed: For example, on August 16, 2022, the IRA, was passed, which among other things, allows for CMS to negotiate prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D, beginning with 10 high-cost drugs paid for by Medicare Part D starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond.
+Added: For example, on August 16, 2022, the IRA, was passed, which among other things, allows for CMS to negotiate prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D, beginning with 10 high-cost drugs paid for by Medicare Part D in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond.
The legislation subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply with the legislation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law or for taking price increases that exceed inflation.
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If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, a product candidate may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.
+Added: Changes to United States federal regulatory agencies may cause disruptions and delays in government approval processes and regulations relating to our product candidates.
+Added: On January 20, 2025, President Trump signed an executive order creating an advisory commission, the Department of Government Efficiency, tasked with eliminating regulations, cutting expenditures, and restructuring federal agencies.
+Added: Any future government proposals to reduce or eliminate budgetary deficits may include reduced allocations to the FDA and other related U.S.
+Added: government agencies.
+Added: These budgetary pressures may result in a reduced ability by the FDA and others to perform their respective roles.
+Added: Kennedy Jr., the Secretary of the U.S.
+Added: Department of Health and Human Services ("HHS"), which oversees the FDA, has previously stated his intent to reform, downsize or restructure these agencies.
+Added: For example, HHS terminated 10,000 employees in 2025, and the FDA has released a plan to phase out animal testing requirements in preclinical safety studies.
+Added: 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, our current or any future product candidates may not achieve regulatory approval.
+Added: Even if we are successful in achieving regulatory approval for one of more of our product candidates, such approval could be significantly delayed by changes at the FDA.
Risks Related to Intellectual Property
6 unchanged sentences
patents and patent applications may also be subject to interference or derivation proceedings, and U.S.
−Removed: patents may be subject to reexamination, post-grant review and/or inter parties review proceedings in the USPTO.
+Added: patents may be subject to reexamination, post-grant review and/or inter partes review proceedings in the USPTO.
International patents may also be subject to opposition or comparable proceedings in the corresponding international patent office, which could result in either loss of the patent or denial of the patent application, or loss or reduction in the scope of one or more of the claims of the patent or patent application.
7 unchanged sentences
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications.
−Removed: We rely on our outside counsel and employ an outside firm to pay these fees due to USPTO and non-U.S.
+Added: We rely on our, and our licensors rely on their, outside counsel and employ an outside firm to pay these fees due to USPTO and non-U.S.
patent agencies.
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Our commercial success depends in part upon our ability to develop, manufacture, market and sell product candidates without alleged or actual infringement, misappropriation or other violation of the patents and proprietary rights of third parties.
−Removed: Litigation relating to infringement or misappropriation of patent and other intellectual property rights in the pharmaceutical and biotechnology field is common, including patent infringement lawsuits, and such interference, derivation, reexamination, post-grant review, inter parties review and opposition proceedings before the USPTO and corresponding international patent offices.
+Added: Litigation relating to infringement or misappropriation of patent and other intellectual property rights in the pharmaceutical and biotechnology field is common, including patent infringement lawsuits, and such interference, derivation, reexamination, post-grant review, inter partes review and opposition proceedings before the USPTO and corresponding international patent offices.
The various markets in which we plan to operate are subject to frequent and extensive litigation regarding patents and other intellectual property rights.
1 unchanged sentence
Numerous United States, EU and other internationally issued 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.
−Removed: For example, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 that potentially cover certain parts of the intellectual property included in CTIM-76.
−Removed: As well, we are aware of a pending patent application in the United States and certain foreign jurisdictions that, if issued, would expire in 2042, and that potentially covers certain parts of the intellectual property included in CTIM-76.
+Added: For example, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 and March 2042 that potentially cover certain parts of the intellectual property included in CTIM-76.
As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our current and any future product candidates may be subject to claims of infringement of the intellectual property rights of third parties.
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These patent applications may have priority over patent applications filed by us.
−Removed: For example, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 that potentially cover certain parts of the intellectual property included in CTIM-76.
−Removed: As well, we are aware of a pending patent application in the United States and certain foreign jurisdictions that, if issued, would expire in 2042, and that potentially covers certain parts of the intellectual property included in CTIM-76.
+Added: For example, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 and March 2042 that potentially cover certain parts of the intellectual property included in CTIM-76.
While we believe we will have reasonable defenses against any potential claim of infringement, including challenging the validity of any such patents, we may not be successful in such efforts, and we also may not be able to obtain a license to such patents on commercially reasonable terms, or at all.
2 unchanged sentences
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad.
−Removed: Such challenges may result in loss of exclusivity or freedom to operate 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 technology and products, or limit the duration of the patent protection of our technology and products.
+Added: challenges may result in loss of exclusivity or freedom to operate 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 technology and products, or limit the duration of the patent protection of our technology and products.
In the United States, the natural expiration of a patent is generally 20 years after it is filed.
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If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.
−Removed: If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation with respect to our current and any future product candidates, thereby potentially extending the term of marketing exclusivity for such product candidates, our business may be harmed.
−Removed: In the United States, a patent that covers an FDA-approved drug or biologic may be eligible for a term extension designed to restore the period of the patent term that is lost during the premarket regulatory review process conducted by the FDA.
−Removed: Depending upon the timing, duration and conditions of FDA marketing approval of our current and any future product candidates, one or more of our U.S.
−Removed: patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act,
−Removed: which permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process.
−Removed: In the European Union, our current and any future product candidates may be eligible for term extensions based on similar legislation.
−Removed: In either jurisdiction, however, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements.
−Removed: Even if we are granted such extension, the duration of such extension may be less than our request.
−Removed: If we are unable to obtain a patent term extension, or if the term of any such extension is less than our request, the period during which we can enforce our patent rights for that product will be in effect shortened and our competitors may obtain approval to market competing products sooner.
−Removed: The resulting reduction of years of revenue from applicable products could be substantial.
We may not be able to protect our intellectual property rights throughout the world.
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Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
+Added: If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation with respect to our current and any future product candidates, thereby potentially extending the term of marketing exclusivity for such product candidates, our business may be harmed.
+Added: In the United States, a patent that covers an FDA-approved drug or biologic may be eligible for a term extension designed to restore the period of the patent term that is lost during the premarket regulatory review process conducted by the FDA.
+Added: Depending upon the timing, duration and conditions of FDA marketing approval of our current and any future product candidates, one or more of our U.S.
+Added: patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, which permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process.
+Added: In the European Union, our current and any future product candidates may be eligible for term extensions based on similar legislation.
+Added: In either jurisdiction, however, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements.
+Added: Even if we are granted such extension, the duration of such extension may be less than our request.
+Added: If we are unable to obtain a patent term extension, or if the term of any such extension is less than our request, the period during which we can enforce our patent rights for that product will be in effect shortened and our competitors may obtain approval to market competing products sooner.
+Added: The resulting reduction of years of revenue from applicable products could be substantial.
Changes in U.S.
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Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations.
−Removed: In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.
+Added: In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of
+Added: patents, once obtained.
Depending on decisions by the U.S.
2 unchanged sentences
Our common stock may be volatile or may decline regardless of our operating performance.
−Removed: The market price for our common stock is likely to be volatile, in part because our shares have been traded publicly for only a few years.
−Removed: In addition, the market price of our common stock has and may continue to fluctuate significantly in response to several factors, most of which we cannot control, including:
+Added: The market price of our common stock has been, and may continue to be, volatile and fluctuate significantly in response to several factors, most of which we cannot control, including:
• quarterly variations in our operating results compared to market expectations;
13 unchanged sentences
As a result, you may suffer a loss on your investment.
−Removed: We may not be able to regain and maintain compliance with the continued listing requirements of The Nasdaq Stock Market.
+Added: We may not be able to maintain compliance with the continued listing requirements of The Nasdaq Stock Market.
Our common stock is listed on The Nasdaq Stock Market.
1 unchanged sentence
On February 27, 2025, we received a letter from Nasdaq stating that the we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”) because our common stock failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days.
−Removed: This letter provides an initial 180 calendar day period, or until August 26, 2025, in which to regain compliance.
−Removed: We may request stockholder approval to undergo a reverse stock split in order to regain compliance with the $1.00 closing bid price requirement.
−Removed: If we do not regain compliance by August 26, 2025, we may be eligible for an additional 180-day grace period.
−Removed: If we fail to regain and maintain compliance with the Minimum Bid Price Rule or we fail to continue to meet all other applicable continued listing requirements for The Nasdaq Stock Market, our common stock may be delisted, which would adversely affect the market liquidity of our common stock and our ability to obtain financing to fund our operations.
−Removed: If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the market price for the shares and trading volume could decline.
−Removed: The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business.
−Removed: If research analysts do not establish and maintain adequate
−Removed: research coverage or if one or more of the analysts who covers us downgrades our common stock or publishes inaccurate or unfavorable research about our business, the market price for our common stock would likely decline.
−Removed: If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which, in turn, could cause the market price or trading volume for our common stock to decline.
−Removed: We do not expect to pay dividends in the foreseeable future, and you must rely on price appreciation of your shares for return on your investment.
−Removed: We have paid no cash dividends on any class of our stock to date, and we do not anticipate paying cash dividends in the near term.
−Removed: For the foreseeable future, we intend to retain any earnings to finance the development and expansion of our business, and we do not anticipate paying any cash dividends on our stock.
−Removed: Accordingly, investors must be prepared to rely on sales of their shares after price appreciation to earn an investment return, which may never occur.
−Removed: Investors seeking cash dividends should not purchase our shares.
−Removed: Any determination to pay dividends in the future will be made at the discretion of our board of directors and will depend on our results of operations, financial condition, contractual restrictions, restrictions imposed by applicable law and other factors our board deems relevant.
−Removed: We may issue debt and equity securities, which are senior to our common stock as to distributions and in liquidation, which could materially adversely affect the market price of our common stock.
−Removed: In the future, we may attempt to increase our capital resources by entering into debt or debt-like financing that is secured by all or up to all of our assets, or issuing debt or equity securities, which could include issuances of commercial paper, medium-term notes, senior notes, subordinated notes or shares.
−Removed: In the event of our liquidation, our lenders and holders of our debt securities would receive a distribution of our available assets before distributions to our stockholders.
−Removed: In addition, any preferred stock, if issued by our company, may have a preference with respect to distributions and upon liquidation, which could further limit our ability to make distributions to our stockholders.
−Removed: Because our decision to incur debt and issue securities in our future offerings will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of our future offerings and debt financing.
−Removed: Further, market conditions could require us to accept less favorable terms for the issuance of our securities in the future.
−Removed: Thus, you will bear the risk of our future offerings reducing the value of your common stock and diluting your interest in our company.
+Added: While we have since regained compliance with the Minimum Bid Price Rule, if we fail to maintain compliance with the Minimum Bid Price Rule or we fail to continue to meet any other applicable continued listing requirement for The Nasdaq Stock Market, our common stock may be delisted, which would adversely affect the market liquidity of our common stock and our ability to obtain financing to fund our operations.
+Added: Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
+Added: Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity and/or debt financings, partnerships and collaborations, licensing agreements or
+Added: other strategic arrangements.
+Added: To the extent that we raise additional capital or pay expenses through the sale or issuance of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences that adversely affect your rights as a common stockholder.
+Added: To the extent that we raise additional capital through debt financing, it would result in increased fixed payment obligations and a portion of our operating cash flows, if any, being dedicated to the payment of principal and interest on such indebtedness.
+Added: In addition, debt financing may involve agreements that include restrictive covenants that impose operating restrictions, such as restrictions on the incurrence of additional debt, the making of certain capital expenditures or the declaration of dividends.
+Added: To the extent we raise additional capital through arrangements with collaborators or otherwise, we may be required to relinquish some of our technologies, research programs, product development activities, product candidates and/or future revenue streams, license our technologies and/or product candidates on unfavorable terms or otherwise agree to terms unfavorable to us.
+Added: Furthermore, any capital raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to advance research programs, product development activities or current or future product candidates.
FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our common stock.
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We are required to publicly report on an ongoing basis as an “emerging growth company” (as defined in the JOBS Act) under the reporting rules set forth under the Exchange Act.
−Removed: For so long as we remain an emerging growth
−Removed: company, we may take advantage of certain exemptions from various reporting requirements that are applicable to other Exchange Act reporting companies that are not emerging growth companies, including but not limited to:
+Added: For so long as we remain an emerging growth company, we may take advantage of certain exemptions from various reporting requirements that are applicable to other Exchange Act reporting companies that are not emerging growth companies, including but not limited to:
• not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;
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Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.
−Removed: We expect to take advantage of these reporting exemptions until we are no longer an emerging growth company.
−Removed: We will remain an emerging growth company until October 19, 2026, although if the market value of our common stock that is held by non-affiliates exceeds $700 million as of any June 30 before that time, we would cease to be an emerging growth company as of the following December 31.
+Added: We expect to take advantage of these reporting exemptions until we are no longer an emerging growth company, which we currently expect to occur as of December 31, 2026.
Because we are subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are not emerging growth companies, our stockholders could receive less information than they might expect to receive from more mature public companies.
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Failure to remedy any material weakness or significant deficiency in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.
−Removed: Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
−Removed: Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity and/or debt financings, partnerships and collaborations, licensing agreements or other strategic arrangements.
−Removed: To the extent that we raise additional capital or pay expenses through the sale or
−Removed: issuance of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences that adversely affect your rights as a common stockholder.
−Removed: To the extent that we raise additional capital through debt financing, it would result in increased fixed payment obligations and a portion of our operating cash flows, if any, being dedicated to the payment of principal and interest on such indebtedness.
−Removed: In addition, debt financing may involve agreements that include restrictive covenants that impose operating restrictions, such as restrictions on the incurrence of additional debt, the making of certain capital expenditures or the declaration of dividends.
−Removed: To the extent we raise additional capital through arrangements with collaborators or otherwise, we may be required to relinquish some of our technologies, research programs, product development activities, product candidates and/or future revenue streams, license our technologies and/or product candidates on unfavorable terms or otherwise agree to terms unfavorable to us.
−Removed: Furthermore, any capital raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to advance research programs, product development activities or current or future product candidates.
General Risk Factors
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The disaster recovery and business continuity plan(s) we have in place may prove inadequate in the event of a serious disaster or similar event.
−Removed: We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business, and such an event could disrupt our operations, cause us to incur remediation costs, damage our reputation and cause a loss of confidence in us and our or third parties’ ability to conduct clinical trials, which could adversely affect our reputation and delay our research and development programs.
+Added: We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business, and such an event could disrupt our operations, cause us to incur remediation costs, damage our reputation and cause a loss of
+Added: confidence in us and our or third parties’ ability to conduct clinical trials, which could adversely affect our reputation and delay our research and development programs.
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
We may now and in the future employ individuals who were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
−Removed: We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or
−Removed: disclosed intellectual property, including trade secrets or other proprietary information, of any of our employees’ former employers or other third parties.
+Added: We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of our employees’ former employers or other third parties.
Litigation may be necessary to defend against these claims.
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Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees and consultants.
−Removed: We could be subject to securities class action litigation.
+Added: We could be subject to securities class action litigation or litigation challenging the validity of provisions in our amended and restated certificate of incorporation or amended and restated bylaws.
In the past, securities class action litigation has often been brought against companies following a decline in the market price of their securities.
This risk is especially relevant for us because biotechnology companies have experienced significant share price volatility in recent years.
+Added: In addition, litigation challenging the validity of provisions in a public company’s certificate of incorporation or bylaws has been increasing in recent years, and we have in the past, and may again in the future, be the subject of such litigation.
If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.