EYPT 10-K & 10-Q changes, risk factors and insider trading

Our operations have consumed substantial amounts of cash. We are currently financing our operations through the sale of capital stock, the receipt of license fees, royalties, and milestone payments. We are developing DURAVYU™ as a potential six-month sustained delivery treatment for wet AMD and diabetic macular edema (DME). However, we have no expectation of revenues from our research and development programs, including DURAVYU™,DURAVYU, prior to the successful completion of clinical trials for such programs. Therefore, we have no sufficient historical evidence to assert that it is probable that we will receive sufficient revenues from our product sales to fund operations. As of December 31, 2024,2025, our cash, cash equivalents, and investments in marketable securities totaled $370.9$306.1 million. We believe that our cash, cash equivalents and investments in marketable securities will enable us to fund operations into the fourth quarter of 2027 beyond topline Phase 3 data for DURAVYU™ in wet AMD ,AMD, expected in 2026. Due to the difficulty and uncertainty associated with the design and implementation of clinical trials, we will continue to assess our cash, cash equivalents, results from investments in marketable securities and future funding requirements. However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations. Actual cash requirements could differ from our projections due to many factors, including, the timing and results of our Phase 2 and Phase 3 clinical trials for DURAVYU™,DURAVYU, additional investments in research and development programs such as EYP-2301, the costs associated with theour ongoing effortsdiscussions for responding towith the subpoenaU.S. government on a negotiated resolution resulting from the U.S. Attorney’s Office for the District of Massachusetts (DOJ) seekinginvestigation production of documents related tointo sales, marketing and promotional practices, includingpractices as pertain to DEXYCU®(DOJ Subpoena),and the costs associated with compliance with any such negotiated resolution, higher interest rates, inflation, supply shortages, competing technological and market developments, and the costs of any strategic acquisitions and/or development of complementary business opportunities.

We have incurred significant losses since our inception and are not profitable. Investment in drug development is highly speculative because it entails substantial upfront operating expenses and significant risk that a product candidate will fail to successfully complete clinical trials, gain regulatory approval or become commercially viable. We continue to incur significant operating expenses due primarily to investments in clinical trials, sales and marketing infrastructure, research and development, and other expenses related to our ongoing operations. For the years ended December 31, 20242025 and 2023,2024, we had losses from operations of $145.9$243.4 million and $75.1$145.9 million ,million, respectively, and net losses of $130.9$232.0 million and $70.8$130.9 million, respectively, and we had a total accumulated deficit of $873.0$1,105.0 million at December 31, 2024.2025.

continue the research and pre-clinical and clinical development of our product candidates, including DURAVYU™ and EYP-2301;

initiate additional pre-clinical studies, clinical trials, or other studies or trials for DURAVYU™,DURAVYU, EYP-2301, and our other product candidates;

Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of, and obtain the regulatory approvals necessary for, the manufacture and commercialization of our product candidates, including DURAVYU™.DURAVYU. To become and remain profitable, we must succeed in developing and commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing pre-clinical testing and clinical trials of our product candidates, discovering additional product candidates, obtaining regulatory approval for these product candidates, manufacturing, marketing, and selling any products for which we or our licensees may obtain regulatory approval, satisfying any post-marketing requirements and obtaining reimbursement for our products from private insurance or government payors. We do not know the extent to which any of our product candidates, including DURAVYU™,DURAVYU, if approved, will generate significant revenue for us, if at all. We may never succeed in these activities and, even if we do, we may never generate revenues significant enough to achieve profitability. Because of the numerous risks and uncertainties associated with pharmaceutical product development and commercialization, we are unable to accurately project when or if we will be able to achieve profitability from operations. Even if we do so, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings, or even continue our operations. Our ability to generate revenue from our future products and product candidates will depend on a number of factors, including:

our ability to create an effective commercial infrastructure and enter into, and maintain, agreements for the commercialization of DURAVYU™ and our other product candidates;

the sufficiency of our existing cash resources will enable us to fund operations into the fourth quarter of 2027;

WeIf receivedwe are unable to reach a subpoenafinal fromnegotiated resolution with the U.S. Attorney’s Office for the District of Massachusetts seeking production of documentsgovernment related to sales,the marketingDOJ and promotional practices, including as pertain to DEXYCU®. Ifinvestigation, the DOJ commencesmay commence an action against us, the actionwhich could have a material adverse effect on our business, financial condition, results of operations, and cash flows. In addition, even if we havefinalize expendeda andnegotiated expectresolution, towe continuemay be required to expend significant additional financial and managerial resources responding to thecomply DOJwith subpoena,such whichagreements, could also haveincluding a materialcorporate adverseintegrity effect on our business, financial condition, results of operations, and cash flows.agreement.

We will need to raise additional capital in the future to help fund the development and commercialization of DURAVYU™ and our other product candidates, if approved. The amount of additional capital we will require will be influenced by many factors, including, but not limited to:

our clinical development plans for DURAVYU™ for the treatment of wet AMD and DME and our other product candidates, including EYP-2301;

the outcome, timing and cost of the regulatory approval process for DURAVYU™ and our other product candidates, including the potential for the FDA (and other equivalent foreign regulatory bodies) to require that we perform more studies and clinical trials than those we currently expect;

our views on the availability, timing and desirability of raising capital; and the costs ofassociated operatingwith asany settlement documents with the U.S. government related to the DOJ investigation, including a publiccorporate company.integrity agreement.

We do not know if additional capital will be available to us when needed or on terms favorable to us or our stockholders. Collaboration, licensing or other commercial agreements may not be available on favorable terms, or at all. If we seek to sell our equity securities under our at-the-market (ATM) program or in another offering, we do not know whether and to what extent we will be able to do so, or on what terms. Further, the rules and regulations of the Nasdaq Stock Market LLC, (Nasdaq), require us to obtain stockholder approval for sales of our equity securities under certain circumstances, which could delay or prevent us from raising additional capital from such sales. Also, the state of the economy and financial and credit markets at the time or times we seek any additional financing may make it more difficult or more expensive to obtain. If available, additional equity financing may be dilutive to stockholders, debt financing may involve restrictive covenants or other unfavorable terms and dilute our existing stockholders’ equity, and funding through collaboration, licensing or other commercial agreements may be on unfavorable terms, including requiring us to relinquish rights to certain of our technologies or products. If adequate financing is not available if and when needed, we may delay, reduce the scope of, or eliminate research or development programs, postpone or cancel the pursuit of product candidates such as DURAVYU™,DURAVYU, including pre-clinical and clinical trials and new business opportunities, or other new products, if any, reduce staff and operating costs, or otherwise significantly curtail our operations to reduce our cash requirements and extend our capital.

As of December 31, 2024,2025, we had U.S. net operating loss (NOL) carryforwards of approximately $369.5$407.2 million for U.S. federal income tax and approximately $326.0$415.0 million for state income tax purposes available to offset future taxable income, and U.S. federal and state research and development tax credits of approximately $10.7$18.3 million, prior to consideration of annual limitations that may be imposed under Section 382 of the Internal Revenue Code of 1986, as amendedamended. (SectionCertain 382).of Ourour U.S. NOL carryforwards beginbegan to expireexpiring in 20242025 ifto the extent not utilized. Our state net operating loss carry forwards will expire between 2033 and 2040, and our U.S. federal and state research and development tax credit carry forwards expire at various dates between calendar years 20242025 and 2040.

Our U.S. NOL and tax credit carryforwards could expire unused and be unavailable to offset future income tax liabilities.liabilities particularly if they are subject to annual limitations on their use. Under Section 382, and corresponding provisions of U.S. state law, if a corporation undergoes an “ownership change,” generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change U.S. NOLs and other pre-change tax attributes, such as research and development tax credits, to offset its post-change income may be limited. The latest analysis performed under Section 382, performed through December 31, 2023, confirmed that the exercise of certain warrants in late September 2018 resulted in a greater than 50% cumulative ownership change, which will cause annual limitations on the use of our then existing NOL balances and other pre-change tax attributes. As a result, if we earn net taxable income in future periods, our ability to use our pre-change U.S. NOL carryforwards to offset U.S. federal taxable income will be subject to limitations, which could potentially result in increased future tax liabilities to us.

In addition, we may experience additional ownership changes in the future as a result of subsequent shifts in our stock ownership, including through completed or contemplated financings, some of which may be outside of our control. If we determine that a future ownership change has occurred and our ability to use our historical net operating loss and tax credit carryforwards is materially limited, it wouldcould harm our future operating results by effectively increasing our future tax obligations.

We are substantially dependent on success of our lead product candidate, DURAVYU™,DURAVYU, which is currently in the clinical development stage. If we are unable to complete development of, obtain regulatory approval for and commercialize DURAVYU™ in one or more indications and in a timely manner, our business, financial condition, results of operations and prospects will be significantly harmed.

Our business and future success depends heavily on our ability to successfully develop, obtain regulatory approval for and successfully commercialize our lead product candidate, DURAVYU™,DURAVYU, which is currently in Phase 3 global, clinical trials for wet AMD and in a Phase 2 clinical trial for DME. DURAVYU™ is our only product candidate in late-stage clinical development and we expect that a substantial portion of our efforts and expenses over the coming years will be devoted to the continued development of DURAVYU™.DURAVYU. If such clinical trials fail to demonstrate safety and efficacy to the satisfaction of the FDA or other regulatory authorities or do not otherwise produce clear or favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of DURAVYU™.DURAVYU. We cannot accurately predict when or if any DURAVYU™ will prove effective or safe in humans or whether it will receive marketing approval or reach successful commercialization. If we are unable to complete clinical development and obtain regulatory approval for DURAVYU™ in one or more indications and in a timely manner, our business, financial condition, results of operations and prospects will be significantly harmed.

Further, in the event DURAVYU™ is approved for marketing but does not gain an adequate level of acceptance among physicians, patients and third parties, we may not generate significant product revenues or become profitable. Market acceptance by physicians, patients and third party payors of DURAVYU™ or other products we may commercialize in the future will depend on a number of factors, some of which are beyond our control, including:

For example, even if DURAVYU™ gains approval by the FDA, physicians and patients may not immediately be receptive to it and may be slow to adopt it. If DURAVYU™ does not achieve an adequate level of acceptance among physicians, patients and third party payors, we may not generate meaningful revenues from DURAVYU™ and we may not become profitable.

The outcomes of clinical trials are uncertain, and delays in the completion of or the termination of any clinical trial of DURAVYU™ or our other product candidates could harm our business, financial condition, and prospects.

Our research and development program for our lead product candidate, DURAVYU™,DURAVYU, and certain of our other product candidates, are still in development. We must demonstrate DURAVYU™’sDURAVYU’s and our other product candidates’ safety and efficacy in humans through extensive clinical testing. Such testing is expensive and time-consuming and requires specialized knowledge and expertise.

failure to reach agreement with the FDA or meet the requirements of other regulatory agency requirementsagencies for clinical trial design or scope of the development program;

delays or failures in obtaining required IRB approval and ethics committee's opinion;

our inability to manufacture DURAVYU™ to scale, necessary to execute our Phase 3 clinical trials in an acceptable time period;

We, the FDA, other regulatory authorities outside the United States, or an IRB may suspend a clinical trial at any time for various reasons, including if it appears that the clinical trial is exposing participants to unacceptable health risks or if the FDA or one or more other regulatory authorities outside the United States find deficiencies in our investigational new drug application or similar application outside the United States or the conduct of the trial. If we experience delays in the completion of, or the termination of, any clinical trial of any of our product candidates, including DURAVYU™,DURAVYU, the commercial prospects of such product candidate will be harmed, and our ability to generate product revenues from such product candidate will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval process, and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition, results of operations, cash flows and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

The ability of the FDA to review and approve new products or review other regulatory submissions can be affected by a variety of factors, including statutory, regulatory and policy changes, inadequate government budget and funding levels, a reduction in the FDA’s workforce and its ability to hire and retain key personnel. Disruptions at the FDA and other agencies may also increase the time to meet with and receive agency feedback, review and/or approve our submissions, conduct inspections, issue regulatory guidance, or take other actions that facilitate the development, approval and marketing of regulated products, which would adversely affect our business. In addition, government proposals to reduce or eliminate budgetary deficits may include reduced allocations to the FDA and other related government agencies. For example, the current presidential administration recently established the Department of Government Efficiency, which implemented a federal government hiring freeze and announced certain additional efforts to reduce federal government employee headcount and the size of the federal government. It is unclear how these executive actions or other potential actions by the administration or other parts of the federal government will impact the FDA or other regulatory authorities that oversee our business. Significant strain on the FDA’s ability to approve regulatory submissions could have a direct impact on the Company if the approval process for DURAVYU™,DURAVYU, which is currently in Phase 3 global clinical trials for wet AMD,AMD and DME, is delayed. Further, budgetary pressures may reduce the FDA’s ability to perform its responsibilities. If a significant reduction in the FDA’s workforce occurs, the FDA’s budget is significantly reduced or a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions or take other actions critical to the development or marketing of our products if approved, which could have a material adverse effect on our business.

Clinical trial results may fail to support continued clinical investigations and/or approval of DURAVYU™ or our other product candidates.

Even if our clinical trials are successfully completed as planned, the results may not support approval of DURAVYU™ or our other product candidates under the laws and regulations of the FDA or other regulatory authorities outside the United States. The clinical trial process may fail to demonstrate that our product candidates are both safe and effective for their intended uses. Pre-clinical and clinical data and analyses are often able to be interpreted in different ways. Even if we view our results favorably, if a regulatory authority has a different view, we may still fail to obtain regulatory approval of our product candidates. This, in turn, would significantly adversely affect our business prospects.

From time to time, we may publicly disclose interim, top-line, initial or preliminary data from our clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data. For example, in October 2024, we announced preliminary results from our Phase 2 VERONA trial for DME. DURAVYU™ is still being studied in the Phase 2 VERONA trial for DME and topline data was announced in February 2025. When reporting interim, top-line, initial or preliminary data from an ongoing trial, we may make assumptions, estimations, calculations and conclusions as part of our analyses of data, and may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, top-line, initial or preliminary results that we report, including the preliminary results from our Phase 2 VERONA trial for DME,report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Interim, top-line, initial and preliminary data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Interim, top-line, initial and preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the interim, top-line, initial or preliminary data we previously published. As a result, interim, top-line, initial and preliminary data, including the preliminary results from our Phase 2 VERONA trial for DME,data should be viewed with caution until the final data are available. Adverse differences between interim, top-line, initial or preliminary data and final data could significantly harm our business prospectus and may cause the price of our common stock to fluctuate or decline.

We may expend significant resources to pursue our lead product candidate, DURAVYU™ for the potential treatment of wet AMD and DME and fail to capitalize on the potential of DURAVYU™,DURAVYU, or our other product candidates, for the potential treatment of other indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, we focus on research programs and product candidates for specific indications. Specifically, with regard to DURAVYU™,DURAVYU, we initiallyhave focused our efforts on the treatment of wet AMD,AMD but have since expanded our efforts to include the treatment ofand DME. As a result, we may forego or delay pursuit of opportunities with DURAVYU™ or other product candidates for the treatment of other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products. Furthermore, until such time as we are able to build a broader product candidate pipeline, if ever, any adverse developments with respect to our leading product candidate, DURAVYU™,DURAVYU, would have a more significant adverse effect on our overall business than if we maintained a broader portfolio of product candidates.

Results from pre-clinical testing, early clinical trials, prior clinical trials, investigator-sponsored studies, and other data and information often do not accurately predict final pivotal clinical trial results. DURAVYU™ relies on vorolanib as its active pharmaceutical agent. Vorolanib is a small molecule tyrosine kinase inhibitor (“TKI”) that has been previously studied by Tyrogenex in Phase 1 and 2 clinical trials as an orally delivered therapy for the treatment of wet AMD. The Phase 2 clinical trial was discontinued due to systemic toxicity. There can be no assurance that such systemic toxicities will not occur in our clinical trial for DURAVYU™.DURAVYU. In addition, data from one pivotal clinical trial may not be predictive of the results of other pivotal clinical trials for the same product candidate, even if the trial designs are the same or similar. Further, as of now, TKIs have not yet been approved, and there is no guarantee of approval, for use in the field of Ophthalmology. Data obtained from pre-clinical studies and clinical trials are susceptible to varying interpretations, which may delay, limit or prevent regulatory approval. Adverse side effects may be observed in clinical trials that delay, limit or prevent regulatory approval, and even after a product candidate has received marketing approval, the emergence of adverse side effects in more widespread clinical practice may cause the product’s regulatory approval to be limited or even rescinded. Additional trials necessary for approval may not be undertaken or may ultimately fail to establish the safety and efficacy of our product candidates.

In addition, while the clinical trials of our product candidates, including our lead product candidate, DURAVYU™,DURAVYU, are designed based on the available relevant information, in view of the uncertainties inherent in drug development, such clinical trials may not be designed with a focus on indications, patient populations, dosing regimens, safety or efficacy parameters or other variables that will provide the necessary safety and efficacy data to support regulatory approval to commercialize the product. In addition, the methods we select to assess particular safety or efficacy parameters may not yield statistically significant results regarding our product candidates’ effects on patients. Even if we believe the data collected from clinical trials of our product candidates are promising, these data may not be sufficient to support approval by the FDA or foreign regulatory authorities. Pre-clinical and clinical data can be interpreted in different ways. Accordingly, the FDA or foreign regulatory authorities could interpret these data in different ways from us or our partners, which could delay, limit or prevent regulatory approval.

Identifying and qualifying patients to participate in clinical trials of our product candidates, including DURAVYU™,DURAVYU, is critical to our success. The timing of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates. If patients are unwilling to participate in our trials because of negative publicity from adverse events in the biotechnology industries, public perception of vaccine safety issues or for other reasons, including competitive clinical trials for similar patient populations, the timeline for recruiting patients, conducting studies, and obtaining regulatory approval of potential products may be delayed. These delays could result in increased costs, delays in advancing our product development, delays in testing the effectiveness of our technology or termination of the clinical trials altogether.

the sufficiency of our existing cash into the fourth quarter of 2027;

Our product and product candidates, if approved and commercialized, may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives which could harm our business.

Federal law also requires that a company that participates in the Medicaid Drug Rebate program report average sales price, or ASP, information each quarter to CMS for certain categories of drugs that are paid under the Medicare Part B program. Manufacturers are required to report the average sales price for certain drugs under the Medicare program regardless of whether they participate in the Medicaid Drug Rebate Program. Manufacturers calculate the ASP based on a statutorily defined formula as well as regulations and interpretations of the statute by CMS. CMS may use these submissions to determine payment rates for drugs under Medicare Part B. Manufacturers wereare required to pay refunds to Medicare for single source drugs or biologicals, or biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages, for units of discarded drug reimbursed by Medicare Part B in excess of 10 percent of total allowed charges under Medicare Part B for that drug. Manufacturers that fail to pay refunds could be subject to civil monetary penalties of 125 percent of the refund amount.

If we commercialize any future products, we may have reporting and other obligations under the Medicaid Drug Rebate Program, Medicare Part B, the 340B program, and the VA/FSS program, which are described in the risk factor entitled “Our products and product candidates, if approved and commercialized, may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives which could harm our businessbusiness.”. Pricing and rebate calculations vary across products and programs, are complex, and are often subject to interpretation by us, governmental or regulatory agencies, and the courts. In the case of Medicaid pricing data, if we become aware that our reporting for a prior period was incorrect or has changed as a result of a recalculation of the pricing data, we are obligated to resubmit the corrected data for up to three years after those data were originally due. Such restatements and recalculations will increase our costs for complying with the laws and regulations governing the Medicaid Drug Rebate program and could result in an overage or underage in our rebate liability for past quarters. Price recalculations also may affect the ceiling price at which we are required to offer our products under the 340B program and may require us to offer refunds to covered entities.

We were advised by the FDA to show diligence and enroll at least one patient in the protocolled trial before submitting a new Deferral Extension Request. We submitted a pediatric study protocol to the FDA as required. We have identified clinical sites and continued study start-up activities with dosing of a first patient in January 2022. In February 2022, we requested a PREA Deferral Extension because of the unavoidable delays in this program due, among other things, to the Pandemic. TheIn June 2025, a deferral extension to complete the study was granted by the FDA, extending the study deadline to June 30, 2025.2027. As of December 31, 2024,2025, the study remains ongoing.

In addition, manufacturers of drug products and their facilities are subject to payment of substantial user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP regulations and adherence to commitments made in the NDA. In the event our product candidates are successful, we will also need to comply with some of the FDA’s manufacturing regulations for devices with respect to YUTIQ®.devices. We and our third-party providers are generally required to maintain compliance with cGMP and other stringent requirements and are subject to inspections by the FDA and comparable agencies in other jurisdictions to confirm such compliance. Any delay, interruption or other issues that arise in the manufacture, fill-finish, packaging, or storage of our products as a result of a failure of our facilities or the facilities or operations of third parties to pass any regulatory agency inspection could significantly impair our ability to commercialize our products. Significant noncompliance could also result in the imposition of monetary penalties or other civil or criminal sanctions and damage our reputation.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, additional oversight and reporting requirements if we become subject to a corporate integrity agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations. For example, see “1A- Risk Factors – If we are unable to reach a final negotiated resolution with the U.S. government related to the DOJ investigation, the DOJ may commence an action against us, which could have a material adverse effect on our business, financial condition, results of operations, and cash flows. In addition, even if we finalize a negotiated resolution, we may be required to expend significant additional financial and managerial resources to comply with such agreement.”

If the market opportunities for our product candidates, including DURAVYU™,DURAVYU, are smaller than we believe they are, our results of operations may be adversely affected and our business may suffer.

We focus our research and product development primarily on treatments for eye diseases. Our projections of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with our products and product candidates, such as our projections of the number of patients with wet AMD and DME who may benefit from treatment with DURAVYU™ if it is approved for use, are based on estimates. These estimates may prove to be incorrect and new studies or clinical trials may change the estimated incidence or prevalence of these diseases. The number of patients in the U.S. and elsewhere may turn out to be lower than expected, may not be otherwise amenable to treatment with our products, or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our business. For example, we are developing our leading product candidate, DURAVYU™,DURAVYU, for the treatment of wet AMD. Although we believe wet AMD is a common condition and a leading cause of vision loss for people age 50 and older, our estimates of the potential market opportunity for DURAVYU™ may be incorrect.

If any of our productsproduct candidates have newly discovered or developed safety problems, our business would be seriously harmed.

All of our approved products are and will be subject to continued oversight by the FDA or other foreign regulatory bodies, and we cannot assure you that newly discovered or developed safety issues will not arise. Although there were no reported DURAVYU™-relatedDURAVYU-related ocular or systematic serious adverse events (SAEs) in our Phase 2 clinical data, we cannot rule out that issues may arise in the future. For example, with the use of any newly marketed drug by a wider patient population, serious adverse events may occur from time to time that initially do not appear to relate to the drug itself. If such events are subsequently associated with the drug, or if any other safety issue emerges, we or our collaboration partners may voluntarily, or FDA or other regulatory authorities may require that we suspend or cease marketing of our approved products, or modify how we or they market our approved products. In addition, newly discovered safety issues may subject us to substantial potential liabilities and adversely affect our financial condition and business.

The U.S. and state governments have enacted and proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing of our product candidates and restrict or regulate post-approval activities. The U.S. and state governments also have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement, and requirements for substitution of generic products for branded prescription products.

Certain provisions of the Affordable Care Act have been subject to judicial challenges as well as efforts to modify them or to alter their interpretation or implementation. Further, the Bipartisan Budget Act of 2018, among other things, amended the Medicare statute to reduce the coverage gap in most Medicare drugs plans, commonly known as the “donut hole,” by raising the required manufacturer point-of-sale discount from 50% to 70% off the negotiated price (the IRA sunset the coverage gap discount program effective 2025). Additional legislative changes, regulatory changes, and judicial challenges related to the Affordable Care Act remain possible. It is unclear how the Affordable Care Act and its implementation, as well as efforts to modify or invalidate the Affordable Care Act, or portions thereof or its implementation, will affect our business, financial condition, and results of operations. It is possible that the Affordable Care Act, as currently enacted or as it may be amended in the future, and other healthcare reform measures, including those that may be adopted in the future, could have a material adverse effect on our industry generally and on our ability to successfully commercialize our product candidates in the U.S.

We are a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. Our pipeline leverages ourits proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery. The Company’sOur lead product candidate, DURAVYU™,1, is an investigational sustained delivery treatment for anti-vascularvascular endothelial growth factor (anti-VEGFVEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with our bioerodible Durasert E™. drug delivery technology. DURAVYU™ is presentlycurrently being evaluated in Phase 3 clinicalpivotal trials as(LUGANO aand sustained delivery treatmentLUCIA) for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and in Phase 23 clinical trialtrials (COMO and CAPRI) for diabetic macular edema (DME). Additional pipeline programs include EYP-2301, razuprotafib, a TIE-2 agonist, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. EyePoint is headquartered in Watertown, Massachusetts with a commercial manufacturing facility in Northbridge, Massachusetts.

On SeptemberJanuary 3,8, 2024,2025, we announced the appointment of esteemedrenowned retina specialist and industry leaderpioneer FredReginald HassanJ. Sanders, M.D., FASRS to ourthe Company’s Board of Directors.

In February 2025, we announced positive six-month results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU™.DURAVYU. The clinical trial met its primary endpoint with extended time to first supplemental injection compared to aflibercept control for both DURAVYU™ doses. The trial also demonstrated clinically meaningful outcomes including continued safety with no DURAVYU™ related ocular or systemic serious adverse events (SAEs) and an early and sustained improvement in vision and anatomical control. DURAVYU™ 2.7mg demonstrated a +7.1 letter BCVA gain and 76-micron CST reduction at week 24, with a supplement-free rate of 73% versus 50% for eyes treated with aflibercept. These positive Phase 2 VERONA results add to a robust dataset across another key indication demonstrating the potential best-in-class potential for DURAVYU™ in serious retinal diseases.

Cost of sales decreased by $0.9$1.6 million, to $2.1 million for 2025 compared to $3.7 million for 2024 from $4.6 million for 2023.2024. This decrease was primarily dueattributable to lower commercial product sales year over year.

Interest income from investments in marketable securities and institutional money market funds increaseddecreased by $8.1$3.3 million, to $11.8 million for 2025 compared to $15.1 million for 2024 compared to $6.9 million for 2023.2024. This increasedecrease was due primarily to an increase in cash invested in marketable securities. We anticipate a decrease in interest income in immediate future periods dueattributable to lower interest earned on our cash and investment balances due to a general decrease in market interest rates.rates and lower cash available for investment in marketable securities.

Also duringDuring the year ended December 31, 2024,2025, we completed an underwritten public offering with gross proceeds of $161.0$172.5 million. The Company sold 14,636,36312,875,000 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,909,0901,875,000 shares of common stock and, to certain investors, in lieu of common stock, PFWs to purchase 1,500,000 shares of common stock. The shares of common stock were sold at a public offering price of $11.00$12.00 per share.share and the PFWs were sold at $11.999, which represents the price to the public for the shares less the $0.001 per share exercise price for each such PFW.

the duration, scope, and outcome of any governmental inquiries or investigations, including the ongoing DOJ investigation for which we are seeking a final negotiated resolutioninvestigations;

our expectations regarding the timing and clinical development of our other pipeline product candidates;

our belief that our cash, cash equivalents, and investments in marketable securities of $222.5$180.5 million at MarchJune 31,30, 2026, will enable us to fund operations into the fourth quarter of 2027, beyond Phase 3 wet AMD topline data for DURAVYU expected in 2026;

our expectations regarding the warning letter we received from the FDA in July 2024, or the Warning Letter, pertaining to YUTIQ® manufacturing, citing alleged violations of cGMP requirements in connection with an FDA inspection at the our Watertown facility in February 2024 and our fully executed plan which implemented the corrective and preventive actions required by the Warning Letter; and our expectation that we will continue to incur significant expenses and that our operating losses and our net cash outflows to fund operations will continue for the foreseeable future.

EYEPOINT®, DEXYCU®, Durasert®, Durasert E™, DELIVERING INNOVATION TO THE EYE® and WITH AN EYE ON PATIENTS® are our trademarks. ILUVIEN® is ANI’s trademarktrademark. We assigned our trademarks for YUTIQ to Alimera Sciences, Inc. (which was acquired by ANI) and to Ocumension Therapeutics in their respective territories. The reports we file or furnish with the SEC, including this Quarterly Report on Form 10-Q, also contain trademarks, trade names, and service marks of other companies, which are the property of their respective owners.

We are a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. Our pipeline leverages proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery. Our lead product candidate, DURAVYU™ (a/k/a EYP-1901), is an investigational sustained delivery treatment for vascular endothelial growth factor (VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™. EyePoint is headquartered in Watertown, Massachusetts withand has a commercial manufacturing facility in Northbridge, Massachusetts.

DURAVYU brings a potential new multi-mechanism of action paradigm for the treatment of retinal diseases as vorolanib, the active drug in DURAVYU, acts through intracellular inhibition of all VEGF receptors, platelet-derived growth factor (PDGF) receptor, and pro-inflammatory interleukin 6 (IL-6)/JAK1 signaling. Vorolanib has also demonstrated neuroprotection in an in-vivoin vivo model of retinal detachment.

DURAVYU is being evaluated in Phase 3 clinical trials for the potential treatment of wet AMD and DME, the two largest retinal disease markets. Enrollment in the pivotal Phase 3 clinical trials for wet AMD is complete with initial data expected beginning in mid-2026.August 2026. The first patients were dosed in both DME trials in February 20262026, withand enrollment completion was announced in July 2026. The initial data readout for the DME program is expected in Q3the 2026.fourth quarter of 2027.

On FebruaryJuly 18,13, 2026, we announced the appointment of MichaelTarek CampbellS. Hassan, M.D., as Chief CommercialStrategic Science Officer.

Through extensive in vitro and in vivo studies, vorolanib was identified as a potent inhibitor of JAK1, a critical transducer of IL-6 signaling. These data further highlight DURAVYU's multi-mechanism of action and its potential to bringdeliver a synergistic anti-inflammatory effect toalongside theits established VEGF receptorsreceptor and PDGF receptor inhibition forin the treatment of wet AMD and DME.

Three Monthsmonths Endedended MarchJune 31,30, 2026 Compared to Three Monthsmonths Endedended MarchJune 31,30, 2025 (In thousands except share data and percentages:

Product sales, net decreased by $0.2 million, or 35%, to $0.5 million for the threesix months ended MarchJune 31,30, 2026 compared to the same period the prior year. This decrease was primarily attributable to the termination of the ANI commercial supply agreement (CSA) in the second quarter of 2025.

License and collaboration agreement revenue decreased by $11.0$15.7 million, or 99%,96%, to $0.1$0.6 million for the threesix months ended MarchJune 31,30, 2026 compared to the same period the prior year. This decrease was primarily driven by the recognition of remaining deferred revenue related to our 2023 agreement for the license of YUTIQ® product rights in the second quarter of 2025.

Royalty income decreased by $12.5$12.6 million, or 99%, to $0.1 million for the threesix months ended MarchJune 31,30, 2026 compared to the same period the prior year. This decrease was due to the termination of the SWK royalty purchase agreement (RPA) on March 18, 2025.

Cost of sales decreased by $0.3$0.4 million, or 34%,45%, to $0.5 million for the threesix months ended MarchJune 31,30, 2026 compared to the same period the prior year. This decrease was primarily attributable to lower commercial product sales year over year.

The following table summarizes our research and development expenses for the threesix months ended MarchJune 31,30, 2026 and 2025:

Research and development expenses increased by $13.6$41.7 million, or 23%,37%, to $72.1$155.8 million for the threesix months ended MarchJune 31,30, 2026 compared to the same period the prior year. This increase was primarily attributable to ongoing DURAVYU Phase 3 clinical trials for wet AMD and DME and scale-up of the Northbridge commercial manufacturing facility.

Sales and marketing expenses remained consistent and immaterial for the threesix months ended MarchJune 31,30, 2026 compared to the same period the prior year.

General and administrative expenses increased by $1.4$3.7 million, or 10%,15%, to $15.2$29.5 million for the threesix months ended MarchJune 31,30, 2026 compared to the same period the prior year. This increase was primarily attributable to increased personnel costs, including non-cash stock compensation.

Interest (expense) income decreased by $1.3 million, or 36%,20%, to $2.3$5.3 million for the threesix months ended MarchJune 31,30, 2026 compared to the same period the prior year. This decrease was primarily driven by lower cash available for investment in marketable securities.

We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at MarchJune 31,30, 2026 we had a total accumulated deficit of $1,189.8$1,284.3 million. Our operations have been financed primarily from sales of our equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners.

In August 2020, we entered into an at-the-market facility (the ATM Facility) with Cantor Fitzgerald & Co (Cantor). Pursuant to the ATM Facility, we may, at our option, offer and sell shares of its common stock from time to time, through or to Cantor, acting as sales agent. We will pay Cantor a commission of 3.0% of the gross proceeds from any future sales of such shares. During the three months ended March 31, 2026 and 2025, we did not sell any shares of our common stock under our ATM offering facility.