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What changed in EyePoint, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of EyePoint, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+498 added−490 removedSource: 10-K (2026-03-05) vs 10-K (2025-03-06)

Top changes in EyePoint, Inc.'s 2025 10-K

498 paragraphs added · 490 removed · 355 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

163 edited+83 added−68 removed231 unchanged
Biggest changeThe key elements of our strategy include: • Advance DURAVYU™ through Phase 3 clinical development for wet AMD • Plan Phase 3 for DURAVYU™ in DME after EOP2 meeting with FDA • Advance DURAVYU™ into clinical trials in additional indications • Leverage our new state-of-the-art manufacturing facility to support the Company’s next phase of growth • Advance EYP-2301 into clinical development for serious retinal diseases • Expand product pipeline through in-license, partnership or acquisition with focus on molecules that can utilize our Durasert ® technology • Leverage our drug delivery technologies through research collaborations and out-licenses with other pharmaceutical and biopharmaceutical companies, institutions and other organizations The Unmet Need in the Treatment of Retinal Eye Disease – Duration of Action and a New Mechanism of Action (MOA) We are committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases leveraging our best-in-class sustained delivery Durasert ® technology, including bioerodible Durasert E™.
Biggest changeThe key elements of our strategy include: • Advance DURAVYU through Phase 3 clinical development and, if successful, regulatory filings for wet AMD and DME • Prepare for the potential commercial launch of DURAVYU in the United States in anticipation of successful trial outcomes and FDA approval • Leverage our new state-of-the-art Northbridge, MA manufacturing facility to support the potential commercial launch of DURAVYU • Advance DURAVYU into additional retinal disease indications • Advance EYP-2301 into clinical development for serious retinal diseases • Expand product pipeline through internal discovery, research collaborations, in-licensing arrangements, or acquisition The Unmet Need in the Treatment of Retinal Disease – Duration of Action and a New Mechanism of Action (MOA) Currently available large molecule anti-VEGF ligand blocking therapies for wet AMD and DME are frequently discontinued, due in part to the high treatment burden associated with regular injections.
The lower limit of the non-inferiority margin is defined as a -4.5 letters by the FDA with 5 letters representing one line on the eye chart. • Continued positive safety and tolerability profile with no DURAVYU™-related ocular or systemic SAEs. • 89% and 85% reduction in treatment burden, respectively, for the 2mg and 3mg DURAVYU™ doses, when comparing the injections in the 6 months prior to entry into the study vs. the injections administered during the study following DURAVYU™ dosing. • 65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of DURAVYU™. • Both DURAVYU™ doses demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control. • Patient discontinuation up to week 32 was low at 4% with no DURAVYU™ related discontinuation.
The lower limit of the non-inferiority margin is defined as a -4.5 letters by the FDA with 5 letters representing one line on the eye chart. • Continued positive safety and tolerability profile with no DURAVYU-related ocular or systemic SAEs. • 89% and 85% reduction in treatment burden, respectively, for the 2mg and 3mg DURAVYU doses, when comparing the injections in the six months prior to entry into the study vs. the injections administered during the study following DURAVYU dosing. • 65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of DURAVYU. • Both DURAVYU doses demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control. • Patient discontinuation up to week 32 was low at 4% with no DURAVYU related discontinuation.
On July 10, 2017, we entered into an amended and restated collaboration agreement with ANI (the Amended ANI Agreement), pursuant to which we (i) expanded the license to ANI to our proprietary Durasert ® sustained-release drug delivery technology platform to include uveitis, including chronic non-infectious uveitis affecting the posterior segment of the eye, in EMEA and (ii) converted the net profit share arrangement for each licensed product (including ILUVIEN) under the original collaboration agreement with ANI (the Prior ANI Agreement) to a sales-based royalty on a calendar quarter basis commencing July 1, 2017, with payments from ANI due 60 days following the end of each calendar quarter.
On July 10, 2017, we entered into an amended and restated collaboration agreement with ANI (the Amended ANI Agreement), pursuant to which we (i) expanded the license to ANI to our proprietary Durasert ® sustained release drug delivery technology platform to include uveitis, including chronic non-infectious uveitis affecting the posterior segment of the eye, in EMEA and (ii) converted the net profit share arrangement for each licensed product (including ILUVIEN) under the original 13 collaboration agreement with ANI (the Prior ANI Agreement) to a sales-based royalty on a calendar quarter basis commencing July 1, 2017, with payments from ANI due 60 days following the end of each calendar quarter.
Copies of this Annual Report on Form 10-K, and our annual reports on Form 10-K, proxy statements, quarterly reports on Form 10-Q, current reports on Form 8-K and, if applicable, amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, are available free of charge through our website under “Investors – Financial Information – SEC Filings” as soon as reasonably practicable after we electronically file these materials with, or otherwise furnish them to, the SEC.
Copies of this Annual Report on Form 10-K, and our annual reports on Form 10-K, proxy statements, quarterly reports on Form 10-Q, current reports on Form 8-K and, if applicable, amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, are available free of charge 31 through our website under “Investors – Financial Information – SEC Filings” as soon as reasonably practicable after we electronically file these materials with, or otherwise furnish them to, the SEC.
For additional information, please refer to the risk factor entitled “If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions, which could include civil or criminal penalties, as well as 30 private litigation and/or adverse publicity, any of which could negatively affect our operating results and business” set forth under the section titled “Risk Factors” in this Annual Report on Form 10-K.
For additional information, please refer to the risk factor entitled “If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions, which could include civil or criminal penalties, as well as private litigation and/or adverse publicity, any of which could negatively affect our operating results and business” set forth under the section titled “Risk Factors” in this Annual Report on Form 10-K.
An NDA under Section 505(b)(1) of the FD&C Act is a comprehensive application to support approval of a product candidate that includes, among other things, data and information to demonstrate that the proposed drug is safe and effective for its proposed uses, that production methods are adequate to ensure its identity, strength, quality, and purity of the drug, and that proposed labeling is 18 appropriate and contains all necessary information.
An NDA under Section 505(b)(1) of the FD&C Act is a comprehensive application to support approval of a product candidate that includes, among other things, data and information to demonstrate that the proposed drug is safe and effective for its proposed uses, that production methods are adequate to ensure its identity, strength, quality, and purity of the drug, and that proposed labeling is appropriate and contains all necessary information.
The process of obtaining regulatory marketing approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources and may not be successful. 17 Development and Approval Under the FD&C Act, FDA approval of an NDA is required before any new drug can be marketed in the U.S.
The process of obtaining regulatory marketing approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources and may not be successful. Development and Approval Under the FD&C Act, FDA approval of an NDA is required before any new drug can be marketed in the U.S.
For calendar quarters beginning January 1, 2022, 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.
For calendar quarters beginning 26 January 1, 2022, 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.
Under the Pediatric Research Equity Act (PREA), certain applications for approval must also include an assessment, generally based on clinical study data, of the safety and effectiveness of the subject drug in relevant pediatric populations. Before approving an NDA, the FDA will inspect the facility or facilities where the product is manufactured.
Under the Pediatric Research Equity Act (PREA), certain applications for approval must also include an assessment, generally based on clinical study data, of the safety and effectiveness of the subject drug in relevant pediatric populations. 18 Before approving an NDA, the FDA will inspect the facility or facilities where the product is manufactured.
Phase 2 VERONA results include: • Both DURAVYU™ doses (1.34 mg and 2.7mg) met the primary endpoint of extended time to first supplemental injection versus aflibercept control. • DURAVYU™ 2.7mg demonstrated an early and sustained improvement in both BCVA and CST as measured by OCT. o BCVA improved +7.1 letters compared to baseline. o CST improved 75.9 microns compared to baseline representing 74% more drying in DURAVYU™ eyes versus aflibercept control. 10 • Visual and anatomical gains were observed at week 4 demonstrating the immediate bioavailability of DURAVYU™. • 73% of eyes in the DURAVYU™ 2.7mg arm were supplement-free versus 50% in the aflibercept control arm up to week 24 underscoring that the positive efficacy results were driven by treatment with DURAVYU™ and not supplemental injections. • Over two-thirds reduction in treatment burden for 2.7mg dose. • DURAVYU™ favorable safety profile continues: o No DURAVYU™ related ocular or systemic serious adverse events reported o No cases of: ▪ Impaired vision ▪ Endophthalmitis ▪ Retinal vasculitis (occlusive or non-occlusive) ▪ Insert migration ▪ Intraocular inflammation (IOI) 24-week supplement-free patient subgroup analyses from the Phase 2 VERONA clinical trial demonstrate that DURAVYU™ 2.7mg significantly improved vision and fluid compared to the aflibercept control group, including: • BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control • CST improvement of 117.4 microns versus 43.7 microns for aflibercept control • 43% had an absence of DME compared to zero for the aflibercept control arm.
Phase 2 VERONA results included: • Both DURAVYU doses (1.34 mg and 2.7mg) met the primary endpoint of extended time to first supplemental injection versus aflibercept control. • DURAVYU 2.7mg demonstrated an early and sustained improvement in both BCVA and CST as measured by OCT. o BCVA improved +7.1 letters compared to baseline. o CST improved 75.9 microns compared to baseline representing 74% more drying in DURAVYU eyes versus aflibercept control. • Visual and anatomical gains were observed at week 4 demonstrating the immediate bioavailability of DURAVYU. • 73% of eyes in the DURAVYU 2.7mg arm were supplement-free versus 50% in the aflibercept control arm up to week 24 underscoring that the positive efficacy results were driven by treatment with DURAVYU and not supplemental injections. • Over two-thirds reduction in treatment burden for the DURAVYU 2.7mg arm. • DURAVYU favorable safety profile continues: o No DURAVYU related ocular or systemic serious adverse events reported o No cases of: ▪ Impaired vision ▪ Endophthalmitis ▪ Retinal vasculitis (occlusive or non-occlusive) ▪ Insert migration ▪ Intraocular inflammation (IOI) 24-week supplement-free patient subgroup analyses from the Phase 2 VERONA clinical trial demonstrate that DURAVYU 2.7mg significantly improved vision and fluid compared to the aflibercept control group, including: • BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control • CST improvement of 117.4 microns versus 43.7 microns for aflibercept control • 43% had an absence of DME compared to zero for the aflibercept control arm.
We support their physical and mental health by providing tools and resources to help them improve or maintain their health status and encourage engagement in healthy behaviors. Depending on the nature of the work both remote and hybrid work arrangements are available. We also provide robust compensation to meet the needs of our employees.
We support their physical and mental health by providing tools and resources to help them improve or maintain their health status and encourage engagement in healthy behaviors. Depending on the nature of the work both remote and hybrid work arrangements are available. We also provide robust compensation packages to meet the needs of our employees.
Failure to timely pay a Part D inflation rebate is subject to a civil monetary penalty. 27 In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, we must participate in the U.S.
Failure to timely pay a Part D inflation rebate is subject to a civil monetary penalty. In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, we must participate in the U.S.
We may obtain health information from third parties that are subject to privacy and 29 security requirements under HIPAA and we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly obtain individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
We may obtain health information from third parties that are subject to privacy and security requirements under HIPAA and we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly obtain individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
Specifically, the FDA requires that drug-device combination products comply with certain provisions of the Quality System Regulation (QSR), which sets forth the FDA’s manufacturing quality standards for medical devices. In addition to drug safety reporting requirements, the FDA also requires that we comply with some device safety reporting requirements for our drug-device combination product. Advertising and Promotion.
Specifically, the FDA requires that drug-device combination products comply with certain provisions of the Quality System Regulation (QSR), which sets forth the FDA’s manufacturing quality standards for medical devices. 19 In addition to drug safety reporting requirements, the FDA also requires that we comply with some device safety reporting requirements for our drug-device combination product. Advertising and Promotion.
To obtain regulatory approval to commercialize a new drug under EU regulatory systems, we must submit a MAA, to the competent regulatory authority. In the EU, marketing authorization for a medicinal product can be obtained through a centralized, mutual recognition, decentralized procedure, or the national procedure of an individual EU Member State.
To obtain regulatory approval to commercialize a new drug under EU regulatory systems, we must submit an MAA, to the competent regulatory authority. In the EU, marketing authorization for a medicinal product can be obtained through a centralized, mutual recognition, or decentralized procedure, or via the national procedure of an individual EU Member State.
The maximum period of restoration is five years, and the patent cannot be extended to more than 14 years from the date of 21 FDA approval of the product. Only one patent claiming each approved product is eligible for restoration and the patent holder must apply for restoration within 60 days of approval. The U.S.
The maximum period of restoration is five years, and the patent cannot be extended to more than 14 years from the date of FDA approval of the product. Only one patent claiming each approved product is eligible for restoration and the patent holder must apply for restoration within 60 days of approval. The U.S.
We also may participate in the Tricare Retail Pharmacy program, under which we would pay quarterly rebates on utilization of innovator products that are dispensed through the Tricare Retail Pharmacy network to Tricare beneficiaries. The rebates are calculated as the difference between the annual Non-FAMP and FCP.
We 27 also may participate in the Tricare Retail Pharmacy program, under which we would pay quarterly rebates on utilization of innovator products that are dispensed through the Tricare Retail Pharmacy network to Tricare beneficiaries. The rebates are calculated as the difference between the annual Non-FAMP and FCP.
Other states have laws requiring pharmaceutical sales representatives to be registered or licensed, and still others impose limits on co-pay assistance that pharmaceutical companies can offer to patients. In addition, several states require pharmaceutical companies to implement compliance programs or marketing codes.
Other states have laws requiring pharmaceutical sales representatives to be registered or 29 licensed, and still others impose limits on co-pay assistance that pharmaceutical companies can offer to patients. In addition, several states require pharmaceutical companies to implement compliance programs or marketing codes.
Failure to comply with these laws and regulations could result in government enforcement actions and create liability for us (including the imposition of significant civil and/or criminal penalties), private litigation and/or adverse publicity that could negatively affect our business.
Failure to comply with these laws and regulations could result in government scrutiny and enforcement actions and create liability for us (including the imposition of significant civil and/or criminal penalties), private litigation and/or adverse publicity that could negatively affect our business.
Such claims are to be resolved through an ADR panel of 26 government officials rendering a decision that may be appealed to federal court. An ADR proceeding could subject us to onerous procedural requirements and could result in additional liability.
Such claims are to be resolved through an ADR panel of government officials rendering a decision that may be appealed to federal court. An ADR proceeding could subject us to onerous procedural requirements and could result in additional liability.
Conversely, if the principal intended action in the product is achieved by the medical device (and the action of the drug is only ancillary to that of the device), the entire product is regulated as a medical device and should be CE-marked under the EU medical devices legislation.
If the principal intended action in the product is achieved by the medical device (and the action of the drug is only ancillary to that of the device), the entire product is regulated as a medical device and should be CE-marked under the EU medical devices legislation.
Generic Drugs. A generic version of an approved drug is approved by means of an abbreviated NDA, or ANDA, by which the sponsor demonstrates that the proposed product is the same as the approved, brand-name drug, which is referred to as the reference listed drug (RLD).
A generic version of an approved drug is approved by means of an abbreviated NDA, or ANDA, by which the sponsor demonstrates that the proposed product is the same as the approved, brand-name drug, which is referred to as the reference listed drug (RLD).
A “Paragraph IV” certification is an assertion that the patent does not block approval of the later product, either because the patent is invalid or unenforceable or because the patent, even if valid, is not infringed by the new product. Regulatory Exclusivities.
A “Paragraph IV” certification is an assertion that the patent does not block approval of the later product, either because the patent is invalid or unenforceable or because the patent, even if valid, is not infringed by the new product. 20 Regulatory Exclusivities.
In the past, payors have implemented reimbursement metrics and periodically revised those metrics as well as the methodologies used as the basis for reimbursement rates, such as ASP, average manufacturer price, or AMP, and actual acquisition cost.
In the past, payors have implemented reimbursement metrics and periodically revised those metrics as well as the methodologies used as the basis for reimbursement rates, such as average sales price, or ASP, average manufacturer price, or AMP, and actual acquisition cost.
In addition, the process for determining whether a payor will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product once coverage is approved.
In addition, the process for determining whether a payor will provide coverage for a product may be separate from the process for setting the price 25 or reimbursement rate that the payor will pay for the product once coverage is approved.
In addition, guidance on implementation and compliance practices may be issued, updated or otherwise revised. Enforcement by European and UK regulators is generally active, and failure to comply with the GDPR or applicable Member State/UK local law may result in fines, amongst other things (such as notices requiring compliance within a certain timeframe).
In addition, guidance on implementation and compliance practices may be issued, updated or otherwise revised. Enforcement by EU and UK regulators is generally active, and failure to comply with the GDPR or applicable EU Member State/UK local law may result in fines, amongst other things (such as notices requiring compliance within a certain timeframe).
Our Product Candidates DURAVYU™ 1 for wet AMD and DME DURAVYU™ is an investigational product deploying vorolanib, a selective and patent protected TKI, that potentially brings a new mechanism of action and treatment paradigm for retinal diseases beyond existing anti-VEGF large molecule ligand blocking therapies. DURAVYU™ utilizes our bioerodible Durasert E™ technology. 1.
Our Product Candidates DURAVYU for wet AMD and DME DURAVYU is an investigational product deploying vorolanib, a selective and patent protected TKI, that potentially brings a new multi-mechanism of action and treatment paradigm for retinal diseases beyond existing anti-VEGF large molecule ligand blocking therapies. DURAVYU utilizes our bioerodible Durasert E™ technology.
There were no ocular SAEs reported, no drug-related systemic SAEs reported, and all ocular adverse events (AEs) were ≤ grade 2; the only grade 3 AE was not drug-related. In July 2022, we updated the results of the DAVIO clinical trial through 12-months reporting continued positive safety and efficacy results.
There were no ocular SAEs reported, no drug-related systemic SAEs reported, and all ocular adverse events (AEs) were ≤ grade 2; the only grade 3 AE was not drug-related. In July 2022, we updated the results of the Phase 1 DAVIO clinical trial through 12-months reporting continued positive safety and efficacy results.
As the proportion of people in the U.S. age 65 and older grows larger, more people are developing age-related diseases such as AMD. By 2050, the estimated number of people with later stages of AMD such as Neovascular AMD is expected to more than double from 2.07 million to 5.44 million.
As the proportion of people in the U.S. age 65 and older grows larger, more people are developing age-related diseases such as AMD. By 2050, the estimated number of people with later stages of AMD such as wet AMD is expected to more than double from 2.07 million to 5.44 million.
Safety and efficacy data for the DAVIO clinical trial included stable visual acuity (VA) and OCT and a clinically significant reduction in treatment burden of 75% at six months and 73% at 12 months with a median time to supplement of six months.
Safety and efficacy data for the Phase 1 DAVIO clinical trial included stable visual acuity (VA) and OCT and a clinically significant reduction in treatment burden of 75% at six months and 73% at 12 months with a median time to supplement of six months.
Data protection authorities from the different European Member States and the UK may interpret the GDPR and applicable related national laws differently and impose requirements additional to those provided in the GDPR and that sit alongside the GDPR, as set out under applicable local data protection law.
Data protection authorities from the different EU Member States and the UK may interpret the GDPR and applicable related national laws differently and impose requirements additional to those provided in the GDPR and that sit alongside the GDPR, as set out under applicable local data protection law.
Our predecessor, pSivida Limited, was formed in December 2000 as an Australian company incorporated in Western Australia. We subsequently changed our name to pSivida Corp. in May 2008 and again to EyePoint Pharmaceuticals, Inc. in March 2018.
Our predecessor, pSivida Limited, was formed in December 2000 as an Australian company incorporated in Western Australia. We subsequently changed our name to pSivida Corp. in May 2008,to EyePoint Pharmaceuticals, Inc. in March 2018 and EyePoint, Inc. in December 2025.
ITEM 1. B USINESS Overview EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery.
ITEM 1. B USINESS Overview EyePoint, Inc. (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery.
Unlike the centralized authorization procedure, the decentralized marketing authorization procedure requires a separate application to, and leads to separate approval by, the competent authorities of each EU Member State in which the product is to be 22 marketed.
Unlike the centralized authorization procedure, the decentralized marketing authorization procedure requires a separate application to, and leads to separate authorization by, the competent authorities of each EU Member State in which the product is to be marketed.
Compliance with these laws is difficult, constantly evolving, and time consuming. Many of these state laws enable a state attorney general to bring actions and provide private rights of action to consumers as enforcement mechanisms.
Compliance with these laws is complex, constantly evolving, and time consuming. Many of these state laws enable a state attorney general to bring actions and provide private rights of action to consumers as enforcement mechanisms.
Some of the antibodies covered include both VE-PTP and VEGF binding domains. VE-PTP is a negative Tie2 regulator that, when inhibited, can activate the Tie2 pathway leading to downstream signaling that promotes vascular health, stability and decreases vascular permeability and inflammation associated with a number of posterior segment eye diseases.
Some of the antibodies covered include both VE-PTP and VEGF binding domains. VE-PTP is a negative TIE-2 regulator that, when inhibited, can activate the TIE-2 pathway leading to downstream signaling that promotes vascular health, stability and decreases vascular permeability and inflammation associated with a number of posterior segment eye diseases.
In addition, the Company has filed additional patent applications for technology relating to DURAVYU™, that, if issued, could expire in 2043, and for a new injector designed for administration of Durasert ® , that, if issued, could expire in 2042. Under an Asset Purchase Agreement with Aerpio Pharmaceuticals Inc.
The Company has filed additional patent applications for technology relating to DURAVYU, that, if issued, could expire in 2043, and for a new injector designed for administration of Durasert ® , that, if issued, could expire in 2046. Under an Asset Purchase Agreement with Aerpio Pharmaceuticals Inc.
Within 15 days of the adoption, the EMA will forward its opinion to the European Commission for its decision. Following the opinion of the EMA, the European Commission makes a final decision to grant a centralized marketing authorization.
Within 15 days of the adoption, the EMA will forward its opinion to the European Commission for its decision. Following the opinion of the EMA, the European Commission makes a final decision to grant or not a centralized marketing authorization.
If, however, the device is co-packaged or obtained separately from the drug product, it must be CE-marked under the EU medical devices legislation (Regulation (EU) 2017/745 on medical devices or the previous Directives 90/385/EEC and 93/42/EEC).
If, however, the device is co-packaged or obtained separately from the drug product, it must be CE-marked under, and will be governed by, the EU medical devices legislation (Regulation (EU) 2017/745 on medical devices or the previous Directives 90/385/EEC and 93/42/EEC).
There are multiple short acting effective and safe treatments for wet AMD available on the market, including large molecule anti-VEGF intravitreal injectable drugs marketed under the brands names Lucentis, Eylea, Eylea HD, Vabysmo, Beovu, and Avastin (off label).
There are multiple short acting effective and safe treatments for wet AMD available on the market, including large molecule anti-VEGF IVT drugs marketed under the brands names Lucentis, Eylea, Eylea HD, Vabysmo, Beovu, and Avastin (off label).
The royalty rate is subject to reduction under certain circumstances, including when there is no valid claim of a licensed patent that covers a Licensed Product in a particular region. EYP-2301 The Company is advancing EYP-2301 into pre-clinical development. EYP-2301 delivers razuprotafib, f/k/a AKB-9778, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases.
The royalty rate is subject to reduction under certain circumstances, including when there is no valid claim of a licensed patent that covers a Licensed Product in a particular region. EYP-2301 The Company is advancing EYP-2301 into pre-clinical development. EYP-2301 delivers razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases.
The patent claims for methods of use relate primarily to disease indications where activation of Tie2 and associated vascular stabilization are potentially beneficial. The potential expiration dates of the patents and applications in this portfolio range from 2027 to 2041.
The patent claims for methods of use relate primarily to disease indications where activation of TIE-2 and associated vascular stabilization are potentially beneficial. The potential expiration dates of the patents and applications in this portfolio range from 2027 to 2041.
In June 2024, we reported positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial evaluating DURAVYU™ for the treatment of wet AMD including: • Favorable safety profile – No DURAVYU™ related ocular or systemic SAEs reported. 9 • Best Corrected Visual Acuity (BCVA) – Statistically significant visual acuity outcomes with both DURAVYU™ arms change in visual acuity nearly identical to aflibercept control arm through 12 months after a single injection of DURAVYU™. • Central Subfield Thickness (CST) – Strong anatomical control through 12 months after a single injection of DURAVYU™. • Supplement Free – After a single injection of DURAVYU™, approximately half of the treated study eyes were anti-VEGF supplement free, while 22% of the eyes in the aflibercept control arm were administered a supplement despite these control eyes receiving mandated bi-monthly injections through 12 months.
DURAVYU outcomes were consistent and durable in a range of wet AMD patient types. 9 In June 2024, we reported positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial evaluating DURAVYU for the treatment of wet AMD including: • Favorable safety profile – No DURAVYU related ocular or systemic SAEs reported. • Best Corrected Visual Acuity (BCVA) – Statistically significant visual acuity outcomes with both DURAVYU arms change in visual acuity similar to aflibercept control arm through 12 months after a single injection of DURAVYU. • Central Subfield Thickness (CST) – Strong anatomical control through 12 months after a single injection of DURAVYU. • Supplement Free – After a single injection of DURAVYU, approximately half of the treated study eyes were anti-VEGF supplement free, while 22% of the eyes in the aflibercept control arm were administered a supplement despite these control eyes receiving mandated bi-monthly injections through 12 months.
This route is optional for certain other products, including medicinal products that are of significant therapeutic, scientific or technical innovation, or whose authorization would be in the interest of public or animal health at EU level.
This route is optional for certain other products, including medicinal products that are of significant therapeutic, scientific or technical innovation, or whose authorization would be in the interest of patients’ health at EU level.
Our principal executive office is located at 480 Pleasant Street, Suite C400, Watertown, Massachusetts 02472, and our telephone number is (617) 926-5000. 31 Additional Information Our website address is www.eyepointpharma.com . Information contained on, or connected to, our website is not incorporated by reference into this Annual Report on Form 10-K.
Our principal executive office is located at 480 Pleasant Street, Suite C400, Watertown, Massachusetts 02472, and our telephone number is (617) 926-5000. Additional Information Our website address is www.eyepoint.bio . Information contained on, or connected to, our website is not incorporated by reference into this Annual Report on Form 10-K.
We believe that this feature allows us to develop products that deliver optimal concentrations of therapeutics over time and eliminate excessive variability in dosing during treatment. • IVT Delivery .
We believe that this feature allows us to develop products that deliver optimal concentrations of therapeutics over time and minimize variability in dosing during treatment. • IVT Delivery .
In October 2024, we announced the grand opening of our commercial manufacturing facility in Northbridge, MA. The 40,000 plus square foot Good Manufacturing Process (cGMP) compliant commercial manufacturing facility was built to meet U.S. FDA and European Medicines Agency (EMA) standards and will support global manufacturing across the Company’s portfolio, including lead pipeline asset, DURAVYU™ upon potential regulatory approval.
In October 2024, we announced the grand opening of our commercial manufacturing facility in Northbridge, MA. The 41,000 square foot Good Manufacturing Process (cGMP) compliant commercial manufacturing facility was built to meet U.S. FDA and EMA standards and will support global manufacturing across the Company’s portfolio, including lead pipeline asset, DURAVYU upon potential regulatory approval.
European/UK data protection laws, including the GDPR, generally restrict the transfer of personal data from the European Economic Area (EEA), United Kingdom and Switzerland, to the U.S. and most other countries (except those deemed to be adequate by the European Commission/UK Secretary of State as applicable) unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data.
European/UK data protection laws, including the EU and UK GDPR, generally restrict the transfer of personal data from the European Economic Area (EEA) and UK to the U.S. and most other countries (except those deemed to be adequate by the European Commission/UK Science and Technology Secretary of State as applicable) unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data.
The delivery of therapeutics intravitreally can allow the natural barriers of the body to isolate and assist in maintaining appropriate concentrations at the target site to achieve the maximum therapeutic effect while minimizing unwanted systemic effects.
The delivery of therapeutics intravitreally can allow the natural barriers of the body to isolate and assist in maintaining appropriate concentrations locally to achieve the maximum therapeutic effect while minimizing unwanted systemic effects.
In February 2020, we entered into an Exclusive License Agreement (Equinox License Agreement) with Equinox Science, LLC (Equinox), pursuant to which Equinox granted us an exclusive, sublicensable, royalty-bearing right and license to certain patents and other Equinox intellectual property to research, develop, make, have made, use, sell, offer for sale and import the compound vorolanib and any pharmaceutical products comprising the compound for the prevention or treatment of wet AMD, DR and RVO (the Original Field) using our proprietary localized delivery technologies, in each case, throughout the world except China, Hong Kong, Taiwan and Macau (the Territory).
Pursuant to this agreement, Equinox granted us an exclusive, sublicensable, royalty-bearing right and license to certain patents and other Equinox intellectual property to research, develop, make, have made, use, sell, offer for sale and import the compound vorolanib and any pharmaceutical products comprising the compound for the prevention or treatment of wet AMD, DR and RVO (the Original Field) using our proprietary localized delivery technologies, in each case, throughout the world except China, Hong Kong, Taiwan and Macau (the Territory).
If the CHMP accepts to review a medicinal product as a major public health interest, the time limit of 210 days will be reduced to 150 days. It is, however, possible that the CHMP can revert to the standard time limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment.
If the CHMP accepts to review a medicinal product under the accelerated assessment procedure, the time limit of 210 days will be reduced to 150 days. It is, however, possible that the CHMP can revert to the standard time limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment.
A lack of valid transfer mechanisms for GDPR-covered data could increase exposure to enforcement actions as described above, and may affect our business operations and require commercial cost (including potentially limiting our ability to collaborate/work with certain third parties and/or requiring an increase in our data processing capabilities in the EU/UK).
A failure to transfer EU or UK data under a valid transfer mechanisms could increase exposure to enforcement actions as described above and may affect our business operations and require commercial cost (including potentially limiting our ability to collaborate/work with certain third parties and/or requiring an increase in our data processing capabilities in the EU/UK).
This period excludes clock stops during which additional information or written or oral explanation is to be provided by the applicant in response to questions posed by the CHMP. Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest.
This period excludes clock stops during which additional information or written or oral explanations are to be provided by the applicant in response to questions posed by the CHMP. A request for accelerated assessment might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest.
In the EU, for example, similar to the FDA a CTA must be submitted for authorization via the platform ‘Clinical Trials Information System (CTIS) to the competent national authority of each EU Member State in which the clinical trial is to be conducted.
In the EU, for example, similar to the FDA a CTA must be submitted for authorization via the platform ‘Clinical Trials Information System (CTIS) to the competent national authority of each EU Member State (as well as Iceland, Norway and Liechtenstein) in which the clinical trial is to be conducted.
We source the active pharmaceutical ingredient (API) vorolanib from Olon USA and Betta, and various raw materials and components for both DURAVYU™ and its injector from third-party vendors. Our agreements with Betta and these third parties include confidentiality, intellectual property, and supply provisions to protect our proprietary rights related to DURAVYU™.
We source the active pharmaceutical ingredient (API) vorolanib from one supplier, and various raw materials and components for both DURAVYU and its injector from third-party vendors. Our arrangements with these third parties include confidentiality, intellectual property, and supply provisions to protect our proprietary rights related to DURAVYU.
Further, the UK Government may amend/update UK data protection law, which may result in changes to our business operations and potentially incur commercial cost.
Further, the UK Government recently updated UK data protection law, which may result in changes to our business operations and potentially incur commercial cost.
Further, some EU Member States approve a specific price for the medicinal product or may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal on the market. The downward pressure on healthcare costs in general, particularly prescription drugs, has become more intense.
Further, some EU Member States approve a specific price for the medicinal product or may instead adopt a system allowing companies to fix their own, but with direct or indirect controls on the profitability of the company placing the medicinal product on the market. The downward pressure on healthcare costs in general, particularly prescription drugs, has become more intense.
Different pricing and reimbursement schemes exist in other countries. In the EU, each EU Member State can restrict the range of medicinal products for which its national health insurance system provides reimbursement and can control the prices of medicinal products for human use marketed on its territory.
In the EU, each EU Member State can restrict the range of medicinal products for which its national health insurance system provides reimbursement and can control the prices of medicinal products for human use marketed on its territory.
A marketing authorization, irrespective of its route to authorization, may be granted only to an applicant established in the EU. The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid for all 27 EU Member States and three of the four European Free Trade Association States, Iceland, Liechtenstein, and Norway.
A marketing authorization, irrespective of its route to authorization, may be granted only to an applicant established in the EU. 21 The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid for all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway.
However, marketing authorization may be granted to a similar medicinal product with the same orphan indication during the ten-year period with the consent of the marketing authorization holder for the original orphan medicinal product or if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities.
However, marketing authorization may be granted to a similar medicinal product with the same orphan indication during the ten-year period with the consent of the marketing authorization holder for the original orphan medicinal product, if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities, or if the second product is safer, more effective or otherwise clinically superior to the original orphan medicinal product.
In addition to competitive base salaries, these programs include annual discretionary bonuses, equity awards, a 401(k) plan and employer match, an employee stock purchase program, tax advantaged health savings and flexible spending accounts, paid time off, family leave and flexible work schedules, among others. Our broad-based equity programs include all employees.
In addition to competitive base salaries, these programs include annual discretionary bonus payments, equity awards, a 401(k) plan and employer match, an employee stock purchase program, tax advantaged health savings and flexible spending accounts, paid time off and family leave. Our broad-based equity programs include employees across all levels.
In August 2023, the FDA approved EYLEA ® HD (aflibercept 8mg) for wet AMD, DME, and DR based on the pivotal PULSAR and PHOTON trials in which EYLEA ® HD demonstrated clinically equivalent vision gains to EYLEA ® (aflibercept 2 mg) that were maintained with fewer injections.
The FDA also approved Beovu ® brolucizumab injection on October 8, 2019. 15 In August 2023, the FDA approved EYLEA ® HD (aflibercept 8mg) for wet AMD, DME, and DR based on the pivotal PULSAR and PHOTON trials in which EYLEA ® HD demonstrated clinically equivalent vision gains to EYLEA ® (aflibercept 2 mg) that were maintained with fewer injections.
Clinical trials authorized under the Clinical Trials Directive before January 31, 2023, can continue to be conducted under the EU Clinical Trials Directive until January 31, 2025 (from January 31, 2025, any trials approved under the EU Clinical Trials Directive that continue running will need to comply with the EU Clinical Trials Regulation and their sponsors must have recorded information on them in the CTIS).
From January 31, 2025, any trials approved under the EU Clinical Trials Directive that continue running will need to comply with the EU Clinical Trials Regulation and their sponsors must have recorded information on them in the CTIS.
Separate published studies using real world data (one study in the U.S. and another that includes Canada, France, Germany, Ireland, Italy, the Netherlands, UK, and Venezuela) indicate that despite initial efficacy, approved wet AMD treatments still result in vision loss over time.
In February 2025, Susvimo was approved for the treatment of DME. 8 Separate published studies using real world data (one study in the U.S. and another that includes Canada, France, Germany, Ireland, Italy, the Netherlands, UK, and Venezuela) indicate that despite initial efficacy, approved wet AMD treatments still result in vision loss over time.
There has been increased attention to privacy and data security issues that could potentially affect our business, including the EU General Data Protection Regulation including as implemented in the UK (collectively, GDPR), which imposes penalties for the most serious breaches of up to EUR 20 million or 4% of a noncompliant company’s annual global revenue, whichever is greater.
There has been increased attention to privacy and data security issues that could potentially affect our business, such as the EU General Data Protection Regulation (EU GDPR) and the UK General Data Protection Regulation (UK GDPR), which impose penalties for the most serious breaches of up to EUR 20 million/GBP 17.5 million or 4% of a company’s annual global revenue, whichever is greater.
The EU Clinical Trials Regulation entered into force on January 31, 2022, repealing the previous EU Clinical Trials Directive (Directive (EC) 2001/20/EC) and the related national implementing provisions of the individual EU Member States.
The EU Clinical Trials Regulation entered into force on January 31, 2022, repealing the previous EU Clinical Trials Directive (Directive (EC) 2001/20/EC) and the related national implementing provisions of the individual EU Member States. Applications through the CTIS are mandatory from January 31, 2023.
Visual and anatomical outcomes were not meaningfully influenced by differences in patient baseline BCVA, duration of wet AMD diagnosis, or historical treatment burden. DURAVYU™ outcomes were consistent and durable in a range of wet AMD patient types.
Visual and anatomical outcomes were not meaningfully influenced by differences in patient baseline BCVA, duration of wet AMD diagnosis, or historical treatment burden.
The Company’s lead product candidate, DURAVYU™, f/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 with Durasert E™.
The Company’s lead product candidate, DURAVYU™ 1 , 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 the Company's bioerodible Durasert E™ drug delivery technology.
A Durasert ® insert is designed to provide consistent, sustained “zero-order kinetics” release of drug over a desired time period and can generally be tailored for each drug and disease indication. Durasert ® inserts can be developed in both non-erodible or bioerodible formulations. In wet AMD, DURAVYU™ is currently being evaluated in global phase 3 clinical trials (LUGANO and LUCIA).
A Durasert ® insert is designed to provide consistent” sustained release of drug over a desired time period and can generally be tailored for each drug and disease indication. Durasert ® products have been developed in both non-erodible and Durasert E™ bioerodible formulations. In wet AMD, DURAVYU is currently being evaluated in the Phase 3 LUGANO and LUCIA clinical trials.
On December 17, 2020, we sold our interest in royalties payable to us under our license agreement with ANI in connection with ANI's sales of ILUVIEN ® to SWK Funding, LLC (SWK) in exchange for a one-time $16.5 million payment from SWK. Intellectual Property We own or license patents in the U.S. and other countries.
On December 17, 2020, we sold our interest in royalties payable to us under our license agreement with ANI in connection with ANI's sales of ILUVIEN ® to SWK Funding, LLC (SWK) in exchange for a one-time $16.5 million payment from SWK.
Post-Approval Regulation Once approved, drug products are subject to continuing regulation by the FDA. If ongoing regulatory requirements are not met, or if safety or manufacturing problems occur after the product reaches the market, the FDA may at any time withdraw product approval or take actions that would limit or suspend marketing.
If ongoing regulatory requirements are not met, or if safety or manufacturing problems occur after the product reaches the market, the FDA may at any time withdraw product approval or take actions that would limit or suspend marketing.
Prior to in-licensing by the Company, vorolanib was previously studied in Phase 1 and 2 clinical trials as an orally delivered therapy for the treatment of wet AMD and data from these trials demonstrated a positive clinical signal and no ocular toxicity. Market Opportunity in wet AMD Wet AMD occurs when new, abnormal blood vessels grow under the retina.
Prior to in-licensing by the Company, vorolanib was studied in Phase 1 and 2 clinical trials as an orally delivered therapy for the treatment of wet AMD and data from these trials demonstrated a positive clinical signal and no ocular toxicity.
This date range is estimated and based on certain 14 assumptions, including that certain applications will be granted, all necessary fees will be paid and no terminal disclaimers or other limitations on expiration are required for certain patents or applications. The latest expiring U.S patent listed in the U.S.
This patent expiration date range is estimated and this range and other patent expiration dates provided herein are based on certain assumptions, including that certain applications will be granted, all necessary fees will be paid and no terminal disclaimers or other limitations on expiration are required for certain patents or applications.
In January 2022, the FDA approved VABYSMO ® (faricimab), a bispecific antibody Ang-2 and vascular endothelial growth factor-A inhibitor. Also in 2022, two ranibizumab biosimilars, Byooviz and Cimerli entered the market. The FDA also approved Beovu ® brolucizumab injection on October 8, 2019.
In January 2022, the FDA approved VABYSMO ® (faricimab), a bispecific antibody targeting Ang-2 and vascular endothelial growth factor-A. Also in 2022, two ranibizumab biosimilars, Byooviz and Cimerli entered the market.
As a result, increasingly high barriers are being erected to the entry of new products. In addition, we may face competition for our product candidates from lower-priced 28 products in foreign countries that have placed price controls on pharmaceutical products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.
As a result, increasingly high barriers are being erected to the entry of new products. In addition, we may face competition for our product candidates from lower-priced products in foreign countries that have placed price controls on pharmaceutical products.
The GDPR regulates the processing of personal data (including health data from clinical trials) and places certain obligations on the processing of such personal data including ensuring the lawfulness of processing personal data (including obtaining valid consent of the individuals to whom the personal data relates, where applicable), the processing details disclosed to the individuals, the adequacy, relevance and necessity of the personal data collected, the retention of personal data collected, the sharing of personal data with third parties, the transfer of personal data out of the European Economic Area/UK to third countries including the U.S., contracting requirements (such as with clinical trial sites and vendors), the use of personal data in accordance with individual rights, the security of personal data and cybersecurity incident notifications.
Both the EU and UK GDPR regulate the processing of personal data (including health data from clinical trials) and place certain obligations 30 on the processing of such personal data including ensuring the lawfulness of processing personal data (including obtaining valid consent of the individuals to whom the personal data relates, where applicable), the processing details disclosed to the individuals, the adequacy, relevance and limitation of personal data to what is necessary in relation to the purposes for which they are processed, the sharing of personal data with third parties, the transfer of personal data out of the European Economic Area/UK to third countries including the U.S., contracting requirements (such as with clinical trial sites and vendors), the use of personal data in accordance with individual rights, the security of personal data and cybersecurity incident notifications.
There are also two FDA-approved Lucentis biosimilars mediations approved by the FDA. In May of 2024, the FDA approved two aflibercept 2mg biosimilars in Opuviz™ and Yesafili™. In 2021, the FDA approved Susvimo ® (ranibizimab), a first-of-its-kind port delivery system (PDS) with ranibizumab for the treatment of patients with wet AMD.
There are two FDA-approved Lucentis biosimilar mediations and two FDA-approved Eylea biosimilars (Opuviz™ and Yesafili™). In 2021, the FDA approved Susvimo ® (ranibizimab), a first-of-its-kind port delivery system (PDS) with ranibizumab for the treatment of patients with wet AMD. In 2025, Susvimo was approved for the treatment of DME and DR.
By offering needs-based supplemental training, management development and effective communications training our employee satisfaction scores have increased. We survey our employees on a regular basis and report the results of those surveys back to management and our board of directors. As a company our success is rooted in the diversity of our teams and our commitment to inclusion.
By offering needs-based supplemental training, management development, effective communications training and mentorship. We survey our employees on a regular basis and report the results of those surveys back to employees and management while implementing programming to directly address the feedback. As a company our success is rooted in the diversity of our teams and our commitment to inclusion.
The Joint Select Committee did not achieve a targeted deficit reduction, which triggered the legislation’s automatic reductions. In concert with subsequent legislation, this has resulted in aggregate reductions to Medicare payments to providers of, on average, 2% per fiscal year through 2031.
The Joint Select Committee did not achieve a targeted deficit reduction, which triggered the legislation’s automatic reductions. In concert with subsequent legislation, this has resulted in aggregate reductions to Medicare payments to providers. Sequestration is currently set at 2% through the first seven months of fiscal year 2033.
On May 2, 2022, we entered into Amendment #1 to the Equinox License Agreement, pursuant to which the Original Field was expanded to cover the prevention or treatment of ophthalmology indications using the Company’s proprietary localized delivery technologies. 11 In consideration for the rights granted by Equinox, we (i) made a one time, non-refundable, non-creditable upfront cash payment of $1.0 million to Equinox in February 2020, and (ii) agreed to pay milestone payments totaling up to $50 million upon the achievement of certain development and regulatory milestones, consisting of (a) completion of a Phase 2 clinical trial for the compound or a licensed product, (b) the filing of a new drug application (NDA) or foreign equivalent for the compound or a licensed product in the United States, European Union, or United Kingdom and (c) regulatory approval of the compound or a licensed product in the United States, European Union, or United Kingdom.
In consideration for the rights granted by Equinox, we (i) made a one time, non-refundable, non-creditable upfront cash payment of $1.0 million to Equinox in February 2020, and (ii) agreed to pay milestone payments totaling up to $50 million upon the achievement of certain development and regulatory milestones, consisting of (a) completion of a Phase 2 clinical trial for the compound or a licensed product, (b) the filing of a new drug application (NDA) or foreign equivalent for the compound or a licensed product in the United States, European Union, or United Kingdom and (c) regulatory approval of the compound or a licensed product in the United States, European Union, or United Kingdom.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeOur dependence upon third parties for the manufacture of our vorolanib could adversely affect our profit margins or our ability to develop and deliver products on a timely and competitive basis. If for any reason we are unable to obtain or retain third-party manufacturers on commercially acceptable terms, we may not be able to sell DURAVYU™ as planned.
Biggest changeIf for any reason we are unable to obtain or retain third-party manufacturers on commercially acceptable terms, we may not be able to sell DURAVYU as planned. Furthermore, if we encounter delays or difficulties with manufacturers in producing vorolanib, the distribution, marketing and subsequent sales of DURAVYU could be adversely affected.
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. The statutes and regulations that govern marketing approvals, pricing and reimbursement for new drug products vary widely from country to country.
Our 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. The statutes and regulations that govern marketing approvals, pricing and reimbursement for new drug products vary widely from country to country.
Pharmaceutical and other healthcare companies also are subject to other federal false claim laws, including federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs. • HIPAA imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for healthcare benefits, items or services by a healthcare benefit program, which includes both government and privately funded benefits 44 programs; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. • HIPAA, and its implementing regulations, impose certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information and impose notification obligations in the event of a breach of the privacy or security of individually identifiable health information. • Numerous federal and state laws and regulations that address privacy and data security, including state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act, or FTC Act), govern the collection, use, disclosure and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Pharmaceutical and other healthcare companies also are subject to other federal false claim laws, including federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs. • HIPAA imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for healthcare benefits, items or services by a healthcare benefit program, which includes both government and privately funded benefits programs; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. • HIPAA, and its implementing regulations, impose certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information and impose notification obligations in the event of a breach of the privacy or security of individually identifiable health information. • Numerous federal and state laws and regulations that address privacy and data security, including state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act, or FTC Act), govern the collection, use, disclosure and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
The following examples are illustrative: • others may be able to make drug and device components that are the same as or similar to our product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; • we or any of our licensors or collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; • we or any of our licensors or collaborators might not have been the first to file patent applications covering certain of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • the prosecution of our pending patent applications may not result in granted patents; • granted patents that we own or have licensed may not cover our products or may be held not infringed, invalid or unenforceable, as a result of legal challenges by our competitors; • with respect to granted patents that we own or have licensed, especially patents that we either acquire or in-license, if certain information was withheld from or misrepresented to the patent examiner, such patents might be held to be unenforceable; • patent protection on our product candidates may expire before we are able to develop and commercialize the product, or before we are able to recover our investment in the product; • our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for such activities, as well as in countries in which we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in markets where we intend to market our product candidates; • we may not develop additional proprietary technologies that are patentable; • the patents of others may have an adverse effect on our business; and • we may choose not to file a patent application for certain technologies, trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
The following examples are illustrative: • others may be able to make drug and device components that are the same as or similar to our product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; • we or any of our licensors or collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; • we or any of our licensors or collaborators might not have been the first to file patent applications covering certain of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • the prosecution of our pending patent applications may not result in granted patents; 54 • granted patents that we own or have licensed may not cover our products or may be held not infringed, invalid or unenforceable, as a result of legal challenges by our competitors; • with respect to granted patents that we own or have licensed, especially patents that we either acquire or in-license, if certain information was withheld from or misrepresented to the patent examiner, such patents might be held to be unenforceable; • patent protection on our product candidates may expire before we are able to develop and commercialize the product, or before we are able to recover our investment in the product; • our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for such activities, as well as in countries in which we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in markets where we intend to market our product candidates; • we may not develop additional proprietary technologies that are patentable; • the patents of others may have an adverse effect on our business; and • we may choose not to file a patent application for certain technologies, trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
Patient enrollment is affected by a variety of factors including, among others: • severity of the disease under investigation; • design of the trial protocol and size of the patient population required for analysis of the trial’s primary endpoints; • size of the patient population; • eligibility criteria for the trial in question; • perceived risks and benefits of the product candidate being tested; • willingness or availability of patients to participate in our clinical trials; • proximity and availability of clinical trial sites for prospective patients; • our ability to recruit clinical trial investigators with the appropriate competencies and experience, and adequate research staffing to support multiple, concurrent clinical trials; • availability of competing therapies and related clinical trials; • efforts to facilitate timely enrollment in clinical trials; • our ability to obtain and maintain patient consents; • the risk that patients enrolled in clinical trials will drop out of the trials before completion; • patient referral practices of physicians; and • ability to monitor patients adequately during and after treatment.
Patient enrollment is affected by a variety of factors including, among others: • severity of the disease under investigation; • design of the trial protocol and size of the patient population required for analysis of the trial’s primary endpoints; • size of the patient population; • eligibility criteria for the trial in question; • perceived risks and benefits of the product candidate being tested; • willingness or availability of patients to participate in our clinical trials; • proximity and availability of clinical trial sites for prospective patients; • our ability to recruit clinical trial investigators with the appropriate competencies and experience, and adequate research staffing to support multiple, concurrent clinical trials; 39 • availability of competing therapies and related clinical trials; • efforts to facilitate timely enrollment in clinical trials; • our ability to obtain and maintain patient consents; • the risk that patients enrolled in clinical trials will drop out of the trials before completion; • patient referral practices of physicians; and • ability to monitor patients adequately during and after treatment.
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: • their efficacy, safety, and other potential advantages in relation to alternative treatments; • their relative convenience and ease of administration; • the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payors, and by government healthcare programs, including Medicare and Medicaid; • the prevalence and severity of adverse events; • their cost of treatment in relation to alternative treatments, including generic products; • the extent and strength of our third party manufacturer and supplier support; • the extent and strength of marketing and distribution support; • the limitations or warnings contained in a product’s approved labeling; and 35 • distribution and use restrictions imposed by the FDA or other regulatory authorities outside the United States.
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: • their efficacy, safety, and other potential advantages in relation to alternative treatments; • their relative convenience and ease of administration; • the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payors, and by government healthcare programs, including Medicare and Medicaid; • the prevalence and severity of adverse events; • their cost of treatment in relation to alternative treatments, including generic products; • the extent and strength of our third party manufacturer and supplier support; • the extent and strength of marketing and distribution support; • the limitations or warnings contained in a product’s approved labeling; and • distribution and use restrictions imposed by the FDA or other regulatory authorities outside the United States.
Refer to “Healthcare Fraud and Abuse Laws” section of Government Regulation for a more in-depth description of these laws, which include, but are not limited to, the following: • The U.S. federal Anti-Kickback Statute prohibits persons or entities from, among other things, knowingly and willfully soliciting, offering, receiving or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, or arranging for or recommending the purchase, lease or order of, any good or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid. • The federal civil False Claims Act (which can be enforced through “qui tam,” or whistleblower actions, by private citizens on behalf of the federal government) prohibits any person from, among other things, knowingly presenting, or causing to be presented false or fraudulent claims for payment of government funds, or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government, or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the U.S. federal government.
Refer to “Healthcare Fraud and Abuse Laws” section of Government Regulation for a more in-depth description of these laws, which include, but are not limited to, the following: • The U.S. federal Anti-Kickback Statute prohibits persons or entities from, among other things, knowingly and willfully soliciting, offering, receiving or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, or arranging for or recommending the purchase, lease or order of, any good or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid. • The federal civil False Claims Act (which can be enforced through “ qui tam ,” or whistleblower actions, by private citizens on behalf of the federal government) prohibits any person from, among other things, knowingly presenting, or causing to be presented false or fraudulent claims for payment of government funds, or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government, or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the U.S. federal government.
Although we try to ensure that our employees, consultants, independent contractors and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these individuals or we have inadvertently or otherwise used or disclosed confidential information and/or intellectual property, including trade secrets or other proprietary 53 information, of the companies that any such individual currently or formerly worked for or provided services to.
Although we try to ensure that our employees, consultants, independent contractors and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these individuals or we have inadvertently or otherwise used or disclosed confidential information and/or intellectual property, including trade secrets or other proprietary information, of the companies that any such individual currently or formerly worked for or provided services to.
Foreign CMOs or CDMOs may be subject to U.S. legislation or investigations, including the proposed BIOSECURE Act, sanctions, trade restrictions, and other foreign regulatory requirements, which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material, delay or impact clinical trials, have an adverse effect on our clinical drug development efforts and could adversely affect our financial condition and business prospects.
Foreign CMOs or CDMOs may be subject to U.S. legislation or investigations, including the BIOSECURE Act, sanctions, trade restrictions, and other foreign regulatory requirements, which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material, delay or impact clinical trials, have an adverse effect on our clinical drug development efforts and could adversely affect our financial condition and business prospects.
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 36 application outside the United States or the conduct of the trial.
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.
Any of these drugs, therapies, products, approaches, or methods may receive government approval or gain market acceptance more rapidly than our product candidates, may offer therapeutic or cost advantages, or may more effectively treat our targeted diseases or their underlying causes, which could result in our product candidates not being approved, reduce demand for our product candidates or render them noncompetitive or obsolete.
Any of these drugs, therapies, products, approaches, or methods may receive government approval or gain market acceptance more rapidly than our product candidates, may offer therapeutic or cost advantages, or may more effectively treat our targeted diseases or 48 their underlying causes, which could result in our product candidates not being approved, reduce demand for our product candidates or render them noncompetitive or obsolete.
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.
If a significant reduction in the FDA’s workforce occurs, the FDA’s budget is significantly reduced or a 37 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.
Adverse pricing limitations may hinder our ability to recoup our investment in one or more of our products. 40 Our success also depends in part on the extent to which coverage and reimbursement for our product candidates, once commercialized, and related treatments will be available from government health administration authorities, private health insurers and other organizations.
Adverse pricing limitations may hinder our ability to recoup our investment in one or more of our products. Our success also depends in part on the extent to which coverage and reimbursement for our product candidates, once commercialized, and related treatments will be available from government health administration authorities, private health insurers and other organizations.
At both the federal and state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
At both the federal and state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost 43 disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenues, attain profitability, or successfully commercialize our approved products in the U.S. 46 There has been increasing legislative, regulatory, and enforcement interest in the United States with respect to drug pricing and marketing practices.
The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenues, attain profitability, or successfully commercialize our approved products in the U.S. There has been increasing legislative, regulatory, and enforcement interest in the United States with respect to drug pricing and marketing practices.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our product candidates, including interference or derivation proceedings before the USPTO. Numerous U.S. and foreign issued patents and 52 pending patent applications owned by third parties exist in the fields in which we are developing our product candidates.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our product candidates, including interference or derivation proceedings before the USPTO. Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the fields in which we are developing our product candidates.
In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop, or commercialize current or future product candidates. 51 We may not be able to protect our intellectual property rights throughout the world.
In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop, or commercialize current or future product candidates. We may not be able to protect our intellectual property rights throughout the world.
In these circumstances, we may need to defend or assert our patents by various means, including filing lawsuits alleging patent infringement requiring us to engage in complex, lengthy and costly litigation, or other proceedings. In any of these types of proceedings, a court or government agency with jurisdiction may find our patents invalid, unenforceable or not infringed.
In these circumstances, we may need to defend or assert our patents by various means, including 53 filing lawsuits alleging patent infringement requiring us to engage in complex, lengthy and costly litigation, or other proceedings. In any of these types of proceedings, a court or government agency with jurisdiction may find our patents invalid, unenforceable or not infringed.
We have information security policies and systems in place designed to prevent unauthorized access to, use, or disclosure of confidential information, including non-public personal information, but there can be no assurance that such access, use, or disclosure will not occur. or that a court or regulator will agree that the measures we have put in place are reasonable, appropriate, or adequate.
We have information security policies and systems in place designed to prevent unauthorized access to, use, or disclosure of confidential information, including non-public personal information, but there can be no assurance that such access, use, or disclosure 61 will not occur, or that a court or regulator will agree that the measures we have put in place are reasonable, appropriate, or adequate.
Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we 54 may not be able to obtain adequate remedies for such breaches. In addition, our trade secrets may otherwise become known, including through a potential cybersecurity incident, or may be independently developed by competitors.
Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. In addition, our trade secrets may otherwise become known, including through a potential cybersecurity incident, or may be independently developed by competitors.
The degree of market acceptance and commercial success of our product candidates will depend on a number of factors, including the following: • the acceptance of our product candidates by patients and the medical community and the availability, perceived advantages and relative cost, safety and efficacy of alternative and competing treatments; • the effectiveness and timeliness of our preclinical studies and clinical trials, and the usefulness of the data; • our ability to obtain reimbursement for our product candidates from third party payors at levels sufficient to support commercial success; • the sufficiency of our existing cash into 2027; • our access to needed capital; • the cost effectiveness of our products; • the effectiveness of our distribution strategies and operations; • our ability and the ability of our contract manufacturing organizations, or CMOs, as applicable, to manufacture commercial supplies of our products, to remain in good standing with regulatory agencies, and to develop, validate and maintain commercially viable manufacturing processes that are, to the extent required, compliant with cGMP regulations; • the degree to which the approved labeling supports promotional initiatives for commercial success; • a continued acceptable safety profile of our products; • results from additional clinical trials of our products or further analysis of clinical data from completed clinical trials of our products by us or our competitors; • our ability to enforce our intellectual property rights; • our products’ potential advantages over other therapies; • our ability to avoid third-party patent interference or patent infringement claims; and • maintaining compliance with all applicable regulatory requirements.
The degree of market acceptance and commercial success of our product candidates will depend on a number of factors, including the following: • the acceptance of our product candidates by patients and the medical community and the availability, perceived advantages and relative cost, safety and efficacy of alternative and competing treatments; • the effectiveness and timeliness of our preclinical studies and clinical trials, and the usefulness of the data; • our ability to obtain reimbursement for our product candidates from third party payors at levels sufficient to support commercial success; • the sufficiency of our existing cash into the fourth quarter of 2027; • our access to needed capital; • the cost effectiveness of our products; • the effectiveness of our distribution strategies and operations; • our ability and the ability of our contract manufacturing organizations, or CMOs, as applicable, to manufacture commercial supplies of our products, to remain in good standing with regulatory agencies, and to develop, validate and maintain commercially viable manufacturing processes that are, to the extent required, compliant with cGMP regulations; • the degree to which the approved labeling supports promotional initiatives for commercial success; 40 • a continued acceptable safety profile of our products; • results from additional clinical trials of our products or further analysis of clinical data from completed clinical trials of our products by us or our competitors; • our ability to enforce our intellectual property rights; • our products’ potential advantages over other therapies; • our ability to avoid third-party patent interference or patent infringement claims; and • maintaining compliance with all applicable regulatory requirements.
Under this program, we would be obligated to make our “innovator” drugs available for procurement on an FSS contract and charge a price to four federal agencies—VA, DoD, Public Health Service and U.S. Coast Guard—that is no higher than the statutory FCP.
Under this program, we would be obligated to make our “innovator” drugs available for procurement on an FSS contract and charge a price to four federal 42 agencies—VA, DoD, Public Health Service and U.S. Coast Guard—that is no higher than the statutory FCP.
In addition, to the extent that we have to file patent litigation in a federal court against a U.S. patent holder, we would be required to initiate the proceeding in the state of incorporation or residency of such entity. With respect to the validity question, for example, we cannot be certain that no invalidating prior art exists.
In addition, to the extent that we have to file patent litigation in a federal court against a U.S. patent holder, we would be required to initiate the proceeding in the state of incorporation or residency of such entity. With respect to the validity question, for example, we cannot be certain that no invalidating 51 prior art exists.
If they do not timely fulfill their 55 responsibilities or if their performance is inadequate, the development, and commercialization of our product candidates could be delayed. The parties with which we contract for execution of clinical trials play a significant role in the conduct of the trials and the subsequent collection and analysis of data.
If they do not timely fulfill their responsibilities or if their performance is inadequate, the development, and commercialization of our product candidates could be delayed. The parties with which we contract for execution of clinical trials play a significant role in the conduct of the trials and the subsequent collection and analysis of data.
In addition, patents attained by others could preclude or delay our commercialization of a product. There can be no assurance that any products now in development or that we may seek to develop in the future will achieve feasibility, obtain regulatory approval or gain 39 market acceptance.
In addition, patents attained by others could preclude or delay our commercialization of a product. There can be no assurance that any products now in development or that we may seek to develop in the future will achieve feasibility, obtain regulatory approval or gain market acceptance.
These generic equivalents would be significantly less costly than ours to bring to market, and companies that produce generic equivalents are generally able to offer their products at lower prices. Thus, after the introduction of a generic competitor, a significant 48 percentage of the sales of any branded product are typically lost to the generic product.
These generic equivalents would be significantly less costly than ours to bring to market, and companies that produce generic equivalents are generally able to offer their products at lower prices. Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product are typically lost to the generic product.
Therefore, we cannot be certain that we were the first to make the inventions claimed in our pending patent applications, that we were the first to file for patent protection of such inventions, or that we have found all of the potentially relevant prior art relating 50 to our patents and patent applications that could invalidate one or more of our patents or prevent one or more of our patent applications from issuing.
Therefore, we cannot be certain that we were the first to make the inventions claimed in our pending patent applications, that we were the first to file for patent protection of such inventions, or that we have found all of the potentially relevant prior art relating to our patents and patent applications that could invalidate one or more of our patents or prevent one or more of our patent applications from issuing.
Funds paid in satisfaction of judgments, fines, and expenses may be funds we need for the operation of our business and the development of our product candidates, thereby affecting our ability to attain profitability. GENERAL RISK FACTORS We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
Funds paid in satisfaction of judgments, fines, and expenses may be funds we need for the operation of our business and the development of our product candidates, thereby affecting our ability to attain profitability. 60 GENERAL RISK FACTORS We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
Failure to comply with these laws and regulations could result in government enforcement actions and create liability for us, which could include civil and/or criminal penalties, as well as private litigation and/or adverse publicity that could negatively affect our operating results and business.
Failure to comply with these laws and regulations could result in government scrutiny and enforcement actions and create liability for us, which could include civil and/or criminal penalties, as well as private litigation and/or adverse publicity that could negatively affect our operating results and business.
Under a Rule 10b5-1 trading plan, a broker executes trades pursuant to parameters established by the employee, director, or officer when entering into the plan, without further direction from the 59 employee, officer, or director. A Rule 10b5-1 trading plan may be amended or terminated in some circumstances.
Under a Rule 10b5-1 trading plan, a broker executes trades pursuant to parameters established by the employee, director, or officer when entering into the plan, without further direction from the employee, officer, or director. A Rule 10b5-1 trading plan may be amended or terminated in some circumstances.
Our failure to submit monthly/quarterly AMP and Best Brice data on a timely basis could result in a significant civil monetary penalty per day for 42 each day the information is late beyond the due date.
Our failure to submit monthly/quarterly AMP and Best Brice data on a timely basis could result in a significant civil monetary penalty per day for each day the information is late beyond the due date.
It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, such as with respect to proper priority 49 claims, inventorship, claim scope, or patent term adjustments.
It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, such as with respect to proper priority claims, inventorship, claim scope, or patent term adjustments.
We use our own facility for the manufacturing of YUTIQ ® and rely on third party suppliers for key components, and any disruptions to our or our suppliers’ operations could adversely affect YUTIQ ® ’s commercial viability and our ability to supply YUTIQ ® to ANI and Ocumension.
We use our own facility for the manufacturing of YUTIQ ® and rely on third party suppliers for key components, and any disruptions to our or our suppliers’ operations could adversely affect YUTIQ ® ’s commercial viability and our ability to supply YUTIQ ® to Ocumension.
Such disruption could have adverse effects on the development of our product candidates and our business operations. 58 RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK The trading price of the shares of our common stock has been highly volatile, and purchasers of our common stock could incur substantial losses.
Such disruption could have adverse effects on the development of our product candidates and our business operations. RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK The trading price of the shares of our common stock has been highly volatile, and purchasers of our common stock could incur substantial losses.
Regardless of merit or eventual outcome, liability claims may result in: • injury to our reputation and significant negative media attention; • termination of clinical trial sites or entire trial programs that we conduct in the future relating to DURAVYU™ or our other product candidates; • withdrawal of clinical trial participants from any future clinical trial relating to DURAVYU™, and EYP-2301or our other product candidates; • significant costs to defend the related litigation; • substantial money awards to patients; • loss of revenue; • diversion of management and scientific resources from our business operations; and • an increase in product liability insurance premiums or an inability to maintain product liability insurance coverage.
Regardless of merit or eventual outcome, liability claims may result in: • injury to our reputation and significant negative media attention; • termination of clinical trial sites or entire trial programs that we conduct in the future relating to DURAVYU or our other product candidates; • withdrawal of clinical trial participants from any future clinical trial relating to DURAVYU, and EYP-2301 or our other product candidates; • significant costs to defend the related litigation; • substantial money awards to patients; • loss of revenue; • diversion of management and scientific resources from our business operations; and • an increase in product liability insurance premiums or an inability to maintain product liability insurance coverage.
A cybersecurity incident or significant disruption to our computer systems or those on which we rely could result in compromise of, or unauthorized access to or acquisition of, proprietary, confidential, or personal information collected in the course of conducting our business; potential regulatory actions or increased regulatory scrutiny; litigation, including material claims for damages, interruption to our operations; significant remediation expenses; increased cybersecurity protection and insurance costs; damage to our reputation; or otherwise have a material adverse effect on our business, financial condition and operating results.
A cybersecurity incident or significant disruption to our computer systems or those on which we rely could result in compromise of, or unauthorized access to or acquisition of, proprietary, confidential, or personal information collected in the course of conducting our business; potential regulatory actions or increased regulatory scrutiny; litigation, including material claims for damages, interruption to our operations; significant remediation expenses; increased cybersecurity protection and insurance costs; misstated financial reports, damage to our reputation; or otherwise have a material adverse effect on our business, financial condition and operating results.
For example, with the use of any newly marketed drug by a wider patient population, serious adverse events may occur from 45 time to time that initially do not appear to relate to the drug itself.
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.
The cGMP requirements govern, among 56 other things, recordkeeping, production processes, and controls, personnel, and quality control. To ensure that we continue to meet these requirements, we have and will continue to expend significant time, money, and effort.
The cGMP requirements govern, among other things, recordkeeping, production processes, and controls, personnel, and quality control. To ensure that we continue to meet these requirements, we have and will continue to expend significant time, money, and effort.
The steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our proprietary information or infringement of our intellectual property rights, both inside and outside the U.S.
The steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our proprietary information or infringement of our intellectual property rights, both inside and outside 50 the U.S.
If our agreement with Equinox is terminated by Equinox for our uncured material breach, we would lose our license and all rights to the use of vorolanib, from Equinox, for DURAVYU™.
If our agreement with 55 Equinox is terminated by Equinox for our uncured material breach, we would lose our license and all rights to the use of vorolanib, from Equinox, for DURAVYU.
The commencement and completion of clinical trials may be delayed or precluded by a number of factors, including: • decisions not to pursue development of product candidates due to pre-clinical or clinical trial results or market factors; • lack of sufficient funding; • failure to reach agreement with the FDA or other regulatory agency requirements for clinical trial design or scope of the development program; • delays or inability to attract clinical investigators for trials; • clinical sites dropping out of a clinical trial; • time required to add new clinical sites; • delays or inability to recruit patients in sufficient numbers or at the expected rate; • decisions by licensees not to exercise options for products or not to pursue or promote products licensed to them; • adverse side effects; • failure of trials to demonstrate safety and efficacy; • patients’ delays or failure to complete participation in a clinical trial or inability to follow patients adequately after treatment; • changes in the design or manufacture of a product candidate; • failures by, changes in our (or our licensees’) relationship with, or other issues at, CROs, vendors, and investigators responsible for pre-clinical testing and clinical trials; • imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or foreign regulatory authorities; • delays or failures in obtaining required IRB approval; • inability to obtain supplies and/or to manufacture sufficient quantities of materials for use in clinical trials, including vorolanib; • our inability to manufacture DURAVYU™ to scale, necessary to execute our Phase 3 clinical trials in an acceptable time period; • stability issues with clinical materials; • failure to comply with GLP, GCP, cGMP or similar foreign regulatory requirements that affect the conduct of pre-clinical and clinical studies and the manufacturing of product candidates; • requests by regulatory authorities for additional data or clinical trials; • governmental or regulatory agency assessments of pre-clinical or clinical testing that differ from our (or our licensees’) interpretations or conclusions; • governmental or regulatory delays, or changes in approval policies or regulations; and • developments, clinical trial results and other factors with respect to competitive products and treatments, a process which may also create a more competitive environment for patient accrual in clinical trials.
The commencement and completion of clinical trials may be delayed or precluded by a number of factors, including: • failure of trials to demonstrate safety and efficacy; • decisions not to pursue development of product candidates due to pre-clinical or clinical trial results or market factors; • lack of sufficient funding; 36 • failure to reach agreement with the FDA or meet the requirements of other regulatory agencies for clinical trial design or scope of the development program; • delays or inability to attract clinical investigators for trials; • clinical sites dropping out of a clinical trial; • time required to add new clinical sites; • delays or inability to recruit patients in sufficient numbers or at the expected rate; • decisions by licensees not to exercise options for products or not to pursue or promote products licensed to them; • adverse side effects; • patients’ delays or failure to complete participation in a clinical trial or inability to follow patients adequately after treatment; • changes in the design or manufacture of a product candidate; • failures by, changes in our (or our licensees’) relationship with, or other issues at, CROs, vendors, and investigators responsible for pre-clinical testing and clinical trials; • imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or foreign regulatory authorities; • delays or failures in obtaining required IRB approval and ethics committee's opinion; • inability to obtain supplies and/or to manufacture sufficient quantities of materials for use in clinical trials, including vorolanib; • our inability to manufacture DURAVYU to scale, necessary to execute our Phase 3 clinical trials in an acceptable time period; • stability issues with clinical materials; • failure to comply with GLP, GCP, cGMP or similar foreign regulatory requirements that affect the conduct of pre-clinical and clinical studies and the manufacturing of product candidates; • requests by regulatory authorities for additional data or clinical trials; • governmental or regulatory agency assessments of pre-clinical or clinical testing that differ from our (or our licensees’) interpretations or conclusions; • governmental or regulatory delays, or changes in approval policies or regulations; and • developments, clinical trial results and other factors with respect to competitive products and treatments, a process which may also create a more competitive environment for patient accrual in clinical trials.
For example, we currently engage with WuXi Apptec (WuXi), to perform certain process development, manufacturing, and testing associated with one of our product candidates, EYP-2301.
For example, we currently 56 engage with WuXi Apptec (WuXi), to perform certain process development, manufacturing, and testing associated with one of our product candidates, EYP-2301.
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™, which is currently in Phase 3 global clinical trials for wet AMD, is delayed. Further, budgetary pressures may reduce the FDA’s ability to perform its responsibilities.
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, which is currently in Phase 3 global clinical trials for wet AMD and DME, is delayed. Further, budgetary pressures may reduce the FDA’s ability to perform its responsibilities.
If any of our products 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.
If any of our product 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.
Compliance with these laws is difficult, constantly evolving, and time consuming. In addition, state laws govern the privacy and security of health, research and genetic information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
Compliance with these laws is complex, constantly evolving, and time consuming. In addition, state laws govern the privacy and security of health, research and genetic information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
Manufacturers were 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 are 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.
On January 23, 2023, the Company entered into a lease agreement for its new standalone manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts. The facility is Good Manufacturing Practice (GMP) compliant to meet U.S. FDA and European Medicines Agency (EMA) standards and support DURAVYU™’s clinical supply and commercial readiness upon regulatory approval.
On January 23, 2023, the Company entered into a lease agreement for its new standalone manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts. The facility is Good Manufacturing Practice (GMP) compliant to meet U.S. FDA and European Medicines Agency (EMA) standards and support DURAVYU’s clinical supply and commercial readiness upon regulatory approval.
The FTC has brought enforcement actions under both Section 5 of the FTC Act and the Health Breach Notification Rule. Additionally, artificial intelligence (AI)-based solutions , including generative AI, are increasingly being used in the pharmaceutical industry (including by us).
The FTC has brought enforcement actions under both Section 5 of the FTC Act and the Health Breach Notification Rule. 62 Additionally, artificial intelligence (AI)-based solutions , including agentic AI and generative AI, are increasingly being used in the pharmaceutical industry (including by us).
Data protection authorities from the different European Member States and the UK may interpret the GDPR and applicable related national laws differently and impose requirements additional to those provided in the GDPR and that sit alongside the GDPR, as set out under applicable local data protection law.
Data protection authorities from the different EU Member States and the UK may interpret the GDPR and applicable related national laws differently and impose requirements additional to those provided in the GDPR and that sit alongside the GDPR, as set out under applicable local data protection law.
There is a global trend towards more regulation (e.g., the EU AI Act and AI laws passed in the U.S. states) to ensure the ethical use, privacy, and security of AI and the data that it processes.
There is a global trend towards more regulation (e.g., the EU AI Act and AI laws passed in U.S. states) to govern the ethical use, privacy, and security of AI and the data that it processes.
In addition, guidance on implementation and compliance practices may be issued, updated or otherwise revised. Enforcement by European and UK regulators is generally active, and failure to comply with the GDPR or applicable Member State/UK local law may result in fines, amongst other things (such as notices requiring 62 compliance within a certain timeframe).
In addition, guidance on implementation and compliance practices may be issued, updated or otherwise revised. Enforcement by EU and UK regulators is generally active, and failure to comply with the GDPR or applicable EU Member State/UK local law may result in fines, amongst other things (such as notices requiring compliance within a certain timeframe).
We must demonstrate DURAVYU™’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. Clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.
We must demonstrate DURAVYU’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. Clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.
In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive acts or practices in violation of Section 5(a) of the Federal Trade Commission Act (FTC Act).
In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive acts or practices in violation of Section 5(a) of the Federal Trade Commission Act (FTC Act) or state consumer protection statutes.
The price of our common stock and their trading volumes may fluctuate based on a number of factors including, but not limited to: • clinical trials and their results, and other product and technological developments and innovations; • the timing, costs and progress of our commercialization efforts; • FDA and other domestic and international governmental regulatory actions, receipt and timing of approvals of our product candidates, and any denials and withdrawal of approvals; • the duration, scope, and outcome of any governmental inquiries or investigations; • competitive factors, including the commercialization of new products in our markets by our competitors; • advancements with respect to treatment of the diseases targeted by our product candidates; • developments relating to, and actions by, our collaborative partners, including execution, amendment and termination of agreements, achievement of milestones and receipt of payments; • the success of our collaborative partners in marketing any approved products and the amount and timing of payments to us; • availability and cost of capital and our financial and operating results; • actions with respect to pricing, reimbursement and coverage, and changes in reimbursement policies or other practices relating to our products or the pharmaceutical or biotechnology industries generally; • meeting, exceeding or failing to meet analysts’ or investors’ expectations, and changes in evaluations and recommendations by securities analysts; • the use of social media platforms by customers or investors; • the issuance of additional shares upon the exercise of currently outstanding options or warrants or upon the settlement of stock units; • future sales of substantial amounts of shares of our common stock in the market; • economic, industry and market conditions, changes or trends; and • other factors unrelated to us or the pharmaceutical and biotechnology industries.
The price of our common stock and their trading volumes may fluctuate based on a number of factors including, but not limited to: • clinical trials and their results, and other product and technological developments and innovations; • the timing, costs and progress of our commercialization efforts; • FDA and other domestic and international governmental regulatory actions, receipt and timing of approvals of our product candidates, and any denials and withdrawal of approvals; • the duration, scope, and outcome of any governmental inquiries or investigations, including the ongoing DOJ investigation for which we are seeking a final negotiated resolution; • competitive factors, including the commercialization of new products in our markets by our competitors; • advancements with respect to treatment of the diseases targeted by our product candidates; • developments relating to, and actions by, our collaborative partners, including execution, amendment and termination of agreements, achievement of milestones and receipt of payments; • the success of our collaborative partners in marketing any approved products and the amount and timing of payments to us; • availability and cost of capital and our financial and operating results; • actions with respect to pricing, reimbursement and coverage, and changes in reimbursement policies or other practices relating to our products or the pharmaceutical or biotechnology industries generally; • meeting, exceeding or failing to meet analysts’ or investors’ expectations, and changes in evaluations and recommendations by securities analysts; • the use of social media platforms by customers or investors; • the issuance of additional shares upon the exercise of currently outstanding options or warrants or upon the settlement of stock units; • future sales of substantial amounts of shares of our common stock in the market; • economic, industry and market conditions, changes or trends; and • other factors unrelated to us or the pharmaceutical and biotechnology industries.
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™, which is currently in Phase 3 global, clinical trials for wet AMD and in a Phase 2 clinical trial for DME.
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, which is currently in Phase 3 global, clinical trials for wet AMD and DME.
In February 2022, we requested a PREA Deferral Extension because of the unavoidable delays in this program due, among other things, to the Pandemic. The extension was granted by the FDA, extending the study deadline to June 30, 2025. As of December 31, 2024, the study remains ongoing.
In February 2022, we requested a PREA Deferral Extension because of the unavoidable delays in this program due, among other things, to the Pandemic. In June 2025, a deferral extension to complete the study was granted by the FDA, extending the study deadline to June 2027. As of December 31, 2025, the study remains ongoing.
In the U.S., numerous federal and state laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information, including state data breach notification laws, state health information privacy laws, state genetic privacy laws, and federal and state consumer protection and privacy laws (including, for example, Section 5 of the FTC Act and the Health Breach Notification Rule, and the CCPA, as amended by the CPRA).
In the U.S., numerous federal and state laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information, including state data breach notification laws, state health information privacy laws, state genetic privacy laws, and federal and state consumer protection and privacy laws (including, for example, Section 5 of the FTC Act and the Health Breach Notification Rule, and the CCPA).
European/UK data protection laws, including the GDPR, generally restrict the transfer of personal data from the European Economic Area (EEA), United Kingdom, and Switzerland, to the U.S. and most other countries (except those deemed to be adequate by the European Commission/UK Secretary of State as applicable) unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data.
European/UK data protection laws, including the EU and UK GDPR, generally restrict the transfer of personal data from the European Economic Area (EEA) and UK to the U.S. and most other countries (except those deemed to be adequate by the European Commission/UK Science and Technology Secretary of State as applicable) unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data.
Because we have limited financial and managerial resources, we focus on research programs and product candidates for specific indications. Specifically, with regard to DURAVYU™, we initially focused our efforts on the treatment of wet AMD, but have since expanded our efforts to include the treatment of DME.
Because we have limited financial and managerial resources, we focus on research programs and product candidates for specific indications. Specifically, with regard to DURAVYU, we have focused our efforts on the treatment of wet AMD and DME.
We currently conduct our manufacturing operations related to YUTIQ ® in our facility located in Watertown, MA. If regulatory, manufacturing or other problems, require us to suspend or discontinue production at our Watertown, MA facility, we will not be able to have or maintain adequate commercial supply of YUTIQ ® , which would adversely impact our business.
If regulatory, manufacturing or other problems, require us to suspend or discontinue production at our Watertown, MA facility, we will not be able to have or maintain adequate commercial supply of YUTIQ ® , which would adversely impact our business.
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; • whether and to what extent we internally fund, whether and when we initiate, and how we conduct other product development programs; • whether and when we are able to enter into strategic arrangements for our products or product candidates and the nature of those arrangements; • the costs involved in preparing, filing, and prosecuting patent applications, and maintaining, and enforcing our intellectual property rights; • changes in our operating plan, resulting in increases or decreases in our need for capital; • our views on the availability, timing and desirability of raising capital; and • the costs of operating as a public company.
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; 34 • whether and to what extent we internally fund, whether and when we initiate, and how we conduct other product development programs; • whether and when we are able to enter into strategic arrangements for our products or product candidates and the nature of those arrangements; • the costs involved in preparing, filing, and prosecuting patent applications, and maintaining, and enforcing our intellectual property rights; • changes in our operating plan, resulting in increases or decreases in our need for capital; • our views on the availability, timing and desirability of raising capital; and • the costs associated with any settlement documents with the U.S. government related to the DOJ investigation, including a corporate integrity agreement.
In addition, some states have laws requiring pharmaceutical sales representatives to be registered or licensed, and still others impose limits on co-pay assistance that pharmaceutical companies can offer to patients. • The Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, require certain manufacturers of drugs, devices, biologics, and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the CMS information related to certain payments made in the preceding calendar year and other transfers of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, certified nurse-midwives, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
In addition, some states have laws requiring pharmaceutical sales representatives to be registered or licensed, and still others impose limits on co-pay assistance that pharmaceutical companies can offer to patients. • The Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing regulations, require certain manufacturers of drugs, devices, biologics, and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the CMS information related to certain payments made in the preceding calendar year and other transfers of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, certified nurse-midwives, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. 45 Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs.
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.
The U.S. and state governments have enacted and proposed legislative and regulatory changes affecting the healthcare system 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.
Further, the UK Government may amend/update UK data protection law, which may result in changes to our business operations and potentially incur commercial cost.
Further, the UK Government recently updated UK data protection law, which may result in changes to our business operations and potentially incur commercial cost.
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™, 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. 34 Our ability to use our net operating loss carryforwards and other tax attributes may be limited.
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, 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.
We also source various raw materials and components for both DURAVYU™ and its injector from third-party vendors. We do not manufacture any of our supply of vorolanib, and we do not currently plan to develop any capacity to do so.
We currently source vorolanib, the API in DURAVYU, from a sole supplier. We also source various raw materials and components for both DURAVYU and its injector from third-party vendors. We do not manufacture any of our supply of vorolanib, and we do not currently plan to develop any capacity to do so.
ILUVIEN ® is ANI Pharmaceuticals, Inc.’s trademark. The reports we file or furnish with the SEC, including this Annual Report on Form 10-K, also contain trademarks, trade names and service marks of other companies, which are the property of their respective owners.
The reports we file or furnish with the SEC, including this Annual Report on Form 10-K, also contain trademarks, trade names and service marks of other companies, which are the property of their respective owners.
If we fail to comply with applicable regulatory requirements for DEXYCU ® , a regulatory authority may: • issue a warning letter asserting that we are in violation of the law; • seek an injunction or impose civil or criminal penalties or monetary fines; • suspend, modify or withdraw regulatory approval; • suspend any ongoing clinical trials; • refuse to approve a pending NDA or a pending application for marketing authorization or supplements to an NDA or to an application for marketing authorization submitted by us; • seize our product; and/or • refuse to allow us to enter into supply contracts, including government contracts.
If we fail to comply with applicable regulatory requirements for DEXYCU ® , a regulatory authority may: • issue a warning letter asserting that we are in violation of the law; • seek an injunction or impose civil or criminal penalties or monetary fines; • suspend, modify or withdraw regulatory approval; • suspend any ongoing clinical trials; • refuse to approve a pending NDA or a pending application for marketing authorization or supplements to an NDA or to an application for marketing authorization submitted by us; • seize our product; and/or • refuse to allow us to enter into supply contracts, including government contracts. 44 Our relationships with physicians, patients and payors in the U.S. are subject to applicable anti-kickback, fraud and abuse laws and regulations.
A lack of valid transfer mechanisms for GDPR-covered data could increase exposure to enforcement actions as described above, and may affect our business operations and require commercial cost (including potentially limiting our ability to collaborate/work with certain third parties and/or requiring an increase in our data processing capabilities in the EU/UK).
A failure to transfer EU or UK data under a valid transfer mechanism could increase exposure to enforcement actions as described above, and may affect our business operations and require commercial cost (including potentially limiting our ability to collaborate/work with certain third parties and/or requiring an increase in our data processing capabilities in the EU/UK).
Department of Health and Human Services Secretary to negotiate, with respect to Medicare units and subject to a specified cap, the price of a set number of certain high Medicare spend drugs and biologicals for each year starting for Medicare Part D drugs with “initial price applicability year” 2026 and for Medicare Part B drugs with “initial price applicability year” 2028, which prices are used to set reimbursement rates for such drugs and biologicals under Medicare Part B and Part D; • penalizes manufacturers of certain Medicare Part B and Part D drugs for price increases above inflation; and • makes changes to the Medicare Part D benefit, including changes in manufacturer liability under the program through a new Medicare Part D manufacturer discount program.
Department of Health and Human Services Secretary to negotiate, with respect to Medicare units and subject to a specified cap, the price of a set number of certain high Medicare spend drugs and biologicals for each year starting for Medicare Part D drugs with “initial price applicability year” 2026 and for Medicare Part B drugs with “initial price applicability year” 2028, which prices are used to set reimbursement rates for such drugs and biologicals under Medicare Part B and Part D; • penalizes manufacturers of certain Medicare Part B and Part D drugs for price increases above inflation; and • makes changes to the Medicare Part D benefit, including changes in manufacturer liability under the program through a new Medicare Part D manufacturer discount program. 47 Civil monetary penalties (CMPs) could accrue for a failure to comply with certain drug price negotiation program, inflation rebate program, or Part D manufacturer discount program requirements.
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, 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.
As a result, the interim, top-line, initial or preliminary results that we 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.
There has been increased attention to privacy and data security issues that could potentially affect our business, including the EU General Data Protection Regulation including as implemented in the UK, (collectively, GDPR), which imposes penalties for the most serious breaches of up to EUR 20 million or 4% of a noncompliant company’s annual global revenue, whichever is greater.
There has been increased attention to privacy and data security issues that could potentially affect our business, such as the EU General Data Protection Regulation (EU GDPR) and the UK General Data Protection Regulation (UK GDPR) , which impose penalties for the most serious breaches of up to EUR 20 million/ GBP 17.6 million or 4% of a company’s annual global revenue, whichever is greater.
As of December 31, 2024, our cash, cash equivalents, and investments in marketable securities totaled $370.9 million. We believe that our cash, cash equivalents and investments in marketable securities will enable us to fund operations into 2027 beyond topline Phase 3 data for DURAVYU™ in wet AMD , expected in 2026.
As of December 31, 2025, our cash, cash equivalents, and investments in marketable securities totaled $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, expected in 2026.
We anticipate that our expenses will continue to be significant if, and as, we: • 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™, EYP-2301, and our other product candidates; • add additional operational, financial and management information systems, and personnel, including personnel to support our development and commercialization planning efforts; • continue to perform tasks associated with the ongoing DOJ Subpoena; • hire additional commercial, clinical, manufacturing and scientific personnel, and engage third party commercial, clinical and manufacturing organizations; • further develop the manufacturing process for our product candidates; • change or add additional manufacturers or suppliers; • seek regulatory approvals for our product candidates that successfully complete clinical trials; • seek to identify and validate additional product candidates; • acquire or in-license other products, product candidates, and technologies; • maintain, protect, and expand our intellectual property portfolio; • create additional infrastructure to support our product development and planned future commercial sale efforts; and • experience any delays or encounter issues with any of the above.
We anticipate that our expenses will continue to be significant if, and as, we: • continue the research and pre-clinical and clinical development of our product candidates, including DURAVYU and EYP-2301; 32 • initiate additional pre-clinical studies, clinical trials, or other studies or trials for DURAVYU, EYP-2301, and our other product candidates; • add additional operational, financial and management information systems, and personnel, including personnel to support our development and commercialization planning efforts; • comply with the terms of a settlement agreement and corporate integrity agreement in connection with a final negotiated resolution with the U.S. government related to the DOJ investigation; • hire additional commercial, clinical, manufacturing and scientific personnel, and engage third party commercial, clinical and manufacturing organizations; • further develop the manufacturing process for our product candidates; • change or add additional manufacturers or suppliers; • seek regulatory approvals for our product candidates that successfully complete clinical trials; • seek to identify and validate additional product candidates; • acquire or in-license other products, product candidates, and technologies; • maintain, protect, and expand our intellectual property portfolio; • create additional infrastructure to support our product development and planned future commercial sale efforts; and • experience any delays or encounter issues with any of the above.
As of December 31, 2024, we had U.S. net operating loss (NOL) carryforwards of approximately $369.5 million for U.S. federal income tax and approximately $326.0 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 million, prior to consideration of annual limitations that may be imposed under Section 382 of the Internal Revenue Code of 1986, as amended (Section 382).
As of December 31, 2025, we had U.S. net operating loss (NOL) carryforwards of approximately $407.2 million for U.S. federal income tax and approximately $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 $18.3 million, prior to consideration of annual limitations that may be imposed under Section 382 of the Internal Revenue Code of 1986, as amended.
Among the provisions of the Affordable Care Act that have been implemented since enactment and are of importance to the commercialization of our product candidates in the U.S. are the following: • an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs or biologic agents; • an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; • expansion of healthcare fraud and abuse laws, including the U.S. civil False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; • a Medicare Part D coverage gap discount program, in which manufacturers agreed to offer certain point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D (the IRA sunsets the coverage gap discount program effective 2025); • extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; • price reporting requirements for drugs that are inhaled, infused, instilled, implanted, or injected; • expansion of eligibility criteria for Medicaid programs; • addition of entity types eligible for participation in the Public Health Service Act’s 340B drug pricing program; • a requirement to annually report certain information regarding drug samples that manufacturers and distributors provide to physicians; and • a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
Among the provisions of the Affordable Care Act that have been implemented since enactment and are of importance to the commercialization of our product candidates in the U.S. are the following: • an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs or biologic agents; • an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; 46 • expansion of healthcare fraud and abuse laws, including the U.S. civil False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; • a manufacturer discount program, in which manufacturers are, in general, required to provide a 10% discount on a covered Part D drug where a beneficiary is in the initial phase of Part D coverage and a 20% discount where a beneficiary is in the catastrophic phase of Part D coverage; • extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; • price reporting requirements for drugs that are inhaled, infused, instilled, implanted, or injected; • expansion of eligibility criteria for Medicaid programs; • addition of entity types eligible for participation in the Public Health Service Act’s 340B drug pricing program; • a requirement to annually report certain information regarding drug samples that manufacturers and distributors provide to physicians; and • a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
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™, additional investments in research and development programs such as EYP-2301, the costs associated with the ongoing efforts for responding to the subpoena from the U.S.
Actual cash requirements could differ from our projections due to many factors, including, the timing and results of our Phase 3 clinical trials for DURAVYU, additional investments in research and development programs such as EYP-2301, the costs associated with our ongoing discussions with the U.S. government on a negotiated resolution resulting from the U.S.
Our ability to generate revenue from our future products and product candidates will depend on a number of factors, including: • the effectiveness and timeliness of our preclinical studies and clinical trials, and the usefulness of the data; • 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 size of the markets in the territories for which we gain regulatory approval; • our ability to develop our commercial organization capable of sales, marketing, and distribution for any of our product candidates for which we may obtain marketing approval; • our ability to manufacture clinical and commercial supply of our products and product candidates; • our ability to enter into and maintain commercially reasonable agreements with wholesalers, distributors, and other third parties in our supply chain; • the sufficiency of our existing cash resources will enable us to fund operations into 2027; • our access to needed capital; • our success in establishing a commercially viable price for our product candidates; • our ability to manufacture commercial quantities of our product candidates at acceptable cost levels; and • our ability to obtain coverage and adequate reimbursement from third parties, including government payors. 33 We received a subpoena from the U.S.
Our ability to generate revenue from our future products and product candidates will depend on a number of factors, including: • the effectiveness and timeliness of our preclinical studies and clinical trials, and the usefulness of the data; • 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 size of the markets in the territories for which we gain regulatory approval; • our ability to develop our commercial organization capable of sales, marketing, and distribution for any of our product candidates for which we may obtain marketing approval; • our ability to manufacture clinical and commercial supply of our products and product candidates; • our ability to enter into and maintain commercially reasonable agreements with wholesalers, distributors, and other third parties in our supply chain; • the sufficiency of our existing cash resources will enable us to fund operations into the fourth quarter of 2027; • our access to needed capital; • our success in establishing a commercially viable price for our product candidates; • our ability to manufacture commercial quantities of our product candidates at acceptable cost levels; and • our ability to obtain coverage and adequate reimbursement from third parties, including government payors. 33 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.
As part of our business, we and our vendors maintain large amounts of confidential information, including non-public personal information on patients and our employees.
As part of our business, we and our vendors and other third parties with whom we interact maintain large amounts of confidential information, including non-public personal information on patients and our employees.
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 business”.
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 business.” 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.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe also maintain cybersecurity insurance providing coverage for certain costs related to cybersecurity-related incidents that impact our own systems, networks, and technology or the systems, networks and technology of our contractors, consultants, vendors and other business partners. 63 Process for Assessing, Identifying and Managing Material Risks from Cybersecurity Threats Pursuant to the program and its escalation protocols, designated personnel are responsible for assessing the severity of an incident and associated threat, and handling it in accordance with that severity level.
Biggest changeProcess for Assessing, Identifying and Managing Material Risks from Cybersecurity Threats Pursuant to the program and its escalation protocols, designated personnel are responsible for assessing the severity of an incident and associated threat, and handling it in accordance with that severity level. We have relationships with a third-party service provider to assist with cybersecurity containment and remediation efforts.
If the Cyber Security Subcommittee determines there is a reasonable likelihood a notable cybersecurity incident has occurred, then notice will promptly be given to certain members of the Company Executive Team including our President/Chief Executive Officer, Chief Financial Officer, Chief Legal Officer & Corporate Secretary, and Chief People Officer/SVP of IT.
If the Cyber Security Subcommittee determines there is a reasonable likelihood a notable cybersecurity incident has occurred, then notice will promptly be given to certain members of the Company Executive Team including our President/Chief Executive Officer, Chief Financial Officer, Chief Legal Officer & Corporate Secretary, Chief People Officer/SVP of IT and Chief Commercial Officer.
The SVP of IT provides periodic briefings for our senior management team on cybersecurity matters, including the prevention, detection, mitigation, and remediation of cybersecurity incidents and cybersecurity threats. Board Oversight While the Board of Directors has overall responsibility for risk oversight, our Audit Committee oversees cybersecurity risk matters.
The SVP of IT provides periodic briefings for our senior management team on cybersecurity matters, including the prevention, detection, mitigation, and remediation of cybersecurity incidents and cybersecurity threats. Board Oversight While the Board of Directors has overall responsibility for risk oversight, our Compliance Committee oversees cybersecurity risk matters.
The Audit Committee is responsible for reviewing, discussing with management, and overseeing the Company’s cybersecurity and privacy risk exposures and policies. On a quarterly basis, the SVP of IT reports to the Audit Committee on information technology and cybersecurity matters , including key information technology risks.
The Compliance Committee is responsible for reviewing, discussing with management, and overseeing the Company’s cybersecurity and privacy risk exposures and policies. On a quarterly basis, the SVP of IT reports to the Compliance Committee on information technology and cybersecurity matters , including key information technology risks.
Our team leverages over 25 years of experience in various IT leadership roles, including oversight of cyber security functions. Our SVP of IT, and her team, is responsible for the day-to-day management of the cybersecurity program.
Our team leverages over 40 years of experience in various IT leadership roles, including oversight of cyber security functions. Our SVP of IT, and her team, is responsible for the day-to-day management of the cybersecurity program.
The SVP of IT also apprises the Audit Committee and full Board of Cyber Security Incidents consistent with our incident response program, promptly . Cybersecurity Risks Our cybersecurity risk management processes are integrated into our overall Enterprise Risk Management (“ERM”) process.
The SVP of IT also apprises the Compliance Committee and full Board of Cyber Security Incidents consistent with our incident response program, promptly . Cybersecurity Risks 64 Our cybersecurity risk management processes are integrated into our overall Enterprise Risk Management (“ERM”) process.
For additional information, see “Item 1A—Risk Factors.” As of December 31, 2024, we have not experienced any material risks from cybersecurity threats, including as a result of any previous cybersecurity incidents or threats, that have materially affected the business strategy, results of operations or financial condition of the Company or are reasonably likely to have such a material effect.
For additional information, see “Item 1A—Risk Factors.” Although we have experienced phishing and similar attempts for unauthorized access to our information technology systems and data, during the past three years, we have not experienced any material risks from cybersecurity threats, including as a result of any previous cybersecurity incidents or threats, that have materially affected the business strategy, results of operations or financial condition of the Company or are reasonably likely to have such a material effect.
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We have relationships with a number of third-party service providers to assist with cybersecurity containment and remediation efforts.
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We also maintain cybersecurity insurance providing coverage for certain costs related to cybersecurity-related incidents that impact our own systems, networks, and technology or the systems, networks and technology of our contractors, consultants, vendors and other business partners.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe believe our leased facilities are adequate for our present and anticipated needs. Please refer to Note 8 to the Consolidated Financial Statements, included under Item 15, "Exhibits and Financial Statement Schedules," for further details.
Biggest changePlease refer to Note 8 to the Consolidated Financial Statements, included under Item 15, "Exhibits and Financial Statement Schedules," for further details. ITEM 3. LEGAL PROCEEDINGS Information pertaining to legal proceedings can be found in Note 15. Contingencies , to the Notes to Consolidated Financial Statements (Part IV, Item 15 of this Annual Report on Form 10-K). ITEM 4.
On April 5, 2021, we further amended the lease by renting an additional 1,409 square feet of space and extending the term of the lease through May 31, 2025. We took occupancy of the additional space on July 1, 2021.
On April 5, 2021, we further amended the lease by renting an additional 1,409 square feet of space and extending the term of the lease through May 31, 2025. We took occupancy of the additional space on July 1, 2021. On March 31, 2025, we further amended the lease to extend the term of the lease through May 31, 2028.
The lease term, under ASC 842, commenced during the second quarter of 2024. The Company entered into an amendment to the Northbridge Lease, effective September 30, 2024. Pursuant to the amendment, the Company's obligation to pay base rent began March 1, 2025. The Company is responsible for real estate taxes, maintenance, and other operating expenses applicable to the leased premises.
The Company entered into an amendment to the Northbridge Lease, effective September 30, 2024. Pursuant to the amendment, the Company's obligation to pay base rent began March 1, 2025. The Company is responsible for real estate taxes, maintenance, and other operating expenses applicable to the leased premises. We believe our leased facilities are adequate for our present and anticipated needs.
The new leased premises consist of approximately 41,141 square feet. The lease includes a non-cancellable lease term of fifteen years and four months, with two options to extend the lease term for two additional terms of either five years or ten years at 95% of the then-prevailing fair market rent.
The lease includes a non-cancellable lease term of fifteen years and four months, with two options to extend the lease term for two additional terms of either five years or ten years at 95% of the then-prevailing fair market rent. The lease term, under ASC 842, commenced during the second quarter of 2024.
The amendment also reinstated our right to extend the lease for the space we occupy after May 31, 2025, for one additional period of five years.
The amendment also reinstated our right to extend the lease for the space we occupy after May 31, 2025, for one additional period of five years. Rent for the extension period would be at the fair market rent for comparable space in comparable properties in the Watertown area. On January 23, 2023, we entered into a lease agreement with V.E.
Rent for the extension period would be at the fair market rent for comparable space in comparable properties in the Watertown area. 64 On January 23, 2023, we entered into a lease agreement with V.E. Properties IX, LLC for a new standalone manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts.
Properties IX, LLC for a new standalone manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts. The new leased premises consist of approximately 41,141 square feet.
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MINE SAFE TY DISCLOSURES Not applicable. 65 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOC KHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our common stock is traded on the Nasdaq Global Market under the trading symbol “EYPT.” As of February 28, 2025, we had approximately 36 holders of record of our common stock.
Biggest changeITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOC KHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our common stock is traded on the Nasdaq Global Market under the trading symbol “EYPT.” As of February 27, 2026, we had approximately 33 holders of record of our common stock.
Recent Sales of Unregistered Securities Other than as previously disclosed in our Current Reports on Form 8-K or Quarterly Reports on Form 10-Q filed with the SEC, we did not issue any unregistered equity securities during the 12 months ended December 31, 2024. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. ITEM 6. [RESE RVED] 66
Recent Sales of Unregistered Securities Other than as previously disclosed in our Current Reports on Form 8-K or Quarterly Reports on Form 10-Q filed with the SEC, we did not issue any unregistered equity securities during the 12 months ended December 31, 2025. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. ITEM 6. [RESE RVED] 66

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeNet cash used in investing activities for the year ended December 31, 2023, consisted of $3.5 million for the purchase of property and equipment, partially offset by $0.2 million of net cash provided by the sale of marketable securities. 74 Net cash provided by financing activities for the year ended December 31, 2024 totaled $164.0 million and consisted of the following: (i) $163.3 million of net proceeds from the issuance of 14,636,363 shares of our common stock in follow on offering and issuance of 1,299,506 shares of our common stock sold utilizing our ATM; and (ii) $1.5 million of proceeds from exercise of employee stock options and stock issued under our employee stock purchase plan Net cash provided by financing activities for fiscal 2023 totaled $187.1 million and consisted of the following: (i) $215.9 million of net proceeds from the issuance of 15,294,116 shares of our common stock; (ii) $40.5 million used to pay off the SVB loan; (iii) $1.4 million used to pay debt extinguishment costs related to the SVB loan; (iv) $9.6 million of net proceeds from the issuance of 902,769 shares of our common stock sold utilizing our ATM; and (v) $3.4 million of proceeds from exercise of employee stock options and stock issued under our employee stock purchase plan Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that would be material to investors.
Biggest changeNet cash provided by financing activities for the year ended December 31, 2025 totaled $173.7 million and consisted primarily of the following: (i) $173.4 million of net proceeds from the issuance of 12,875,000 shares of our common stock and PFWs to purchase 1,500,000 shares of our common stock in a follow on offering and the issuance of 825,844 shares of our common stock sold utilizing our ATM; (ii) $2.2 million from the exercise of stock options and stock issued under our employee stock option plan; and (iii) $1.9 million used for the settlement of stock units and payment of equity issue costs Net cash provided by financing activities for the year ended December 31, 2024 totaled $164.0 million and consisted primarily of the following: (i) $163.3 million of net proceeds from the issuance of 14,636,363 shares of our common stock in a follow on offering and the issuance of 1,299,506 shares of our common stock sold utilizing our ATM; and (i) $6.0 million from the exercise of stock options and stock issued under our employee stock option plan; and (ii) $5.2 million used for the settlement of stock units and payment of equity issue costs Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that would be material to investors. 74 ITEM 7A.
ITEM 7A. QUANTITATIVE AND QUALITAT IVE DISCLOSURES ABOUT MARKET RISK We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this Item. ITEM 8.
QUANTITATIVE AND QUALITAT IVE DISCLOSURES ABOUT MARKET RISK We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this Item. ITEM 8.
Given the inherent uncertainty associated with these future events, we will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event.
Given the inherent uncertainty associated with these future events, we will 69 not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event.
Applying the practical expedient in paragraph 606-10-32-18, we do not assess whether a significant financing component exists if the period between when we perform our obligations under the contract and when the customer pays is one year or less. None of our contracts contained a significant financing component as of December 31, 2024.
Applying the practical expedient in paragraph 606-10-32-18, we do not assess whether a significant financing component exists if the period between when we perform our obligations under the contract and when the customer pays is one year or less. None of our contracts contained a significant financing component as of December 31, 2025.
The following Management’s Discussion and Analysis (MD&A) provides a narrative of our results of operations for the year ended December 31, 2024, and the comparable period ended December 31, 2023, respectively, and our financial position as of December 31, 2024 and 2023, respectively.
The following Management’s Discussion and Analysis (MD&A) provides a narrative of our results of operations for the year ended December 31, 2025, and the comparable period ended December 31, 2024, respectively, and our financial position as of December 31, 2025 and 2024, respectively.
Recently Adopted and Recently Issued Accounting Pronouncements For a full discussion of recently adopted and recently issued accounting pronouncements, see Note 2, "Significant Accounting Policies" to the Consolidated Financial Statements included under Item 15, "Exhibits and Financial Statement Schedules." Liquidity and Capital Resources We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at December 31, 2024, we had a total accumulated deficit of $873.0 million.
Recently Adopted and Recently Issued Accounting Pronouncements For a full discussion of recently adopted and recently issued accounting pronouncements, see Note 2, "Significant Accounting Policies" to the Consolidated Financial Statements included under Item 15, "Exhibits and Financial Statement Schedules." Liquidity and Capital Resources We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at December 31, 2025, we had a total accumulated deficit of $1,105.0 million.
Our operations have been financed primarily from public and private offerings of our common stock, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners. Financing Activities Also during the year ended December 31, 2024, we completed an underwritten public offering with gross proceeds of $161.0 million.
Our operations have been financed primarily from public and private offerings of our common stock, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners. Financing Activities During the year ended December 31, 2025, we completed an underwritten public offering with gross proceeds of $172.5 million.
In determining the prepaid and accrued balances, we make assessments of the services performed based on various factors, including reporting from third-party CROs and internal tracking of work performed during the period, which are subject to management’s judgment. Actual results could differ from our estimates.
In determining the prepaid and accrued balances, we make assessments of the services performed based on various factors, including reporting from third-party CROs and internal tracking of work performed during the period, which are subject to management’s judgment.
The amount of additional capital we will require will be influenced by many factors, including, but not limited to: 1. the scope, progress, results, and costs of clinical trials of DURAVYU™, as a sustained delivery intravitreal treatment for wet AMD and DME; 73 2. our expectations regarding the timing and clinical development of our product candidates, including DURAVYU™ and EYP-2301; 3. the duration, scope, and outcome of the DOJ Subpoena and its impact on our financial condition, results of operations, or cash flows; 4. whether and to what extent we internally fund, whether and when we initiate, and how we conduct additional pipeline product development programs; 5. payments we receive under any new collaboration agreements or payments expected from existing agreements; 6. whether and when we are able to enter into strategic arrangements for our products or product candidates and the nature of those arrangements; 7. the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing any patent claims; 8. the costs and timing to implement corrective and preventive actions required by the Warning Letter to the satisfaction of the FDA; 9. changes in our operating plan, resulting in increases or decreases in our need for capital; and 10. our views on the availability, timing, and desirability of raising capital.
The amount of additional capital we will require will be influenced by many factors, including, but not limited to: 1. the scope, progress, results, and costs of clinical trials of DURAVYU, as a sustained delivery intravitreal treatment for wet AMD and DME; 2. our expectations regarding the timing and clinical development of our product candidates, including DURAVYU and EYP-2301; 3. the duration and outcome of a potential negotiated settlement with the U.S. government related to the DOJ investigation, including any additional undertakings that the DOJ or HHS requires us to pursue in connection with such negotiated resolution, such as a corporate integrity agreement; 4. whether and to what extent we internally fund, whether and when we initiate, and how we conduct additional pipeline product development programs; 5. payments we receive under any new collaboration agreements or payments expected from existing agreements; 6. whether and when we are able to enter into strategic arrangements for our products or product candidates and the nature of those arrangements; 7. the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing any patent claims; 8. the costs and timing to implement corrective and preventive actions required by the Warning Letter to the satisfaction of the FDA; 9. changes in our operating plan, resulting in increases or decreases in our need for capital; and 10. our views on the availability, timing, and desirability of raising capital.
This was further offset by changes in working capital of $27.8 million, including $30.6 million of deferred revenue related to the agreement to license YUTIQ ® product rights to ANI offset by $2.9 million of other working capital changes.
The change in working capital were $27.8 million, including $30.6 million of deferred revenue related to the agreement to license YUTIQ ® product rights to ANI offset by $2.8 million in other working capital adjustments.
During the year ended December 31, 2024, we sold 1,299,506 shares of our common stock under the ATM facility at a weighted average price of $9.36 per share for gross proceeds of approximately $12.2 million. Share issue costs, including sales agent commissions, totaled approximately $0.4 million.
The shares of common stock were sold at a public offering price of $11.00 per share. During the year ended December 31, 2024, we sold 1,299,506 shares of our common stock under the ATM facility at a weighted average price of $9.36 per share for gross proceeds of approximately $12.2 million.
The MD&A should be read together with our consolidated financial statements and related notes included in this Annual Report on Form 10-K. Overview We are a company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. Our pipeline leverages our proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery.
The MD&A should be read together with our consolidated financial statements and related notes included in this Annual Report on Form 10-K. Overview We are a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases.
The Company’s lead product candidate, DURAVYU™, is an investigational sustained delivery treatment for anti-vascular endothelial growth factor (anti-VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™.
Our pipeline leverages its proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery. Our lead product candidate, DURAVYU™ 1 , 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 our bioerodible Durasert E™ drug delivery technology.
Please refer to Note 3 for further details on the license and collaboration agreements into which we have entered and corresponding amounts of revenue recognized during the current and prior year periods. Deferred Revenue Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue on the accompanying consolidated balance sheets.
Please refer to Note 3 for further details on the license and collaboration agreements into which we have entered and corresponding amounts of revenue recognized during the current and prior year periods.
Research and Development The following table summarizes our research and development expenses for the years ended December 31, 2024 and 2023: December 31, 2024 2023 Direct research and development expenses by program: DURAVYU™ $ 70,818 $ 32,014 Other direct research and development 2,656 714 Unallocated expenses: Personnel (including stock based compensation) 49,676 28,274 Facilities 1,974 175 Other 7,802 3,485 Total research and development expenses 132,926 64,662 Research and development expenses increased by $68.3 million, or 106%, to $132.9 million for 2024 from $64.7 million in the prior year.
Research and Development The following table summarizes our research and development expenses for the years ended December 31, 2025 and 2024: December 31, 2025 2024 Direct research and development expenses by program: DURAVYU $ 149,293 $ 70,818 Other direct research and development 3,036 2,656 Unallocated expenses: Personnel (including stock based compensation) 52,861 49,676 Facilities 4,333 1,974 Other 11,516 7,802 Total research and development expenses 221,039 132,926 Research and development expenses increased by $88.1 million, or 66%, to $221.0 million for 2025 from $132.9 million in the prior year.
Future Funding Requirements At December 31, 2024, we had cash, cash equivalents, and investments in marketable securities of $370.9 million. We expect that our cash and investments in marketable securities will enable us to fund our operations into 2027.
Share issue costs, including sales agent commissions, totaled approximately $0.4 million. Future Funding Requirements At December 31, 2025, we had cash, cash equivalents, and investments in marketable securities of $306.1 million. We expect that our cash and investments in marketable securities will enable us to fund our operations into the fourth quarter of 2027.
Recent Developments • On January 8, 2025, we announced the appointment of renowned retina specialist and industry pioneer Reginald J.
Fiscal 2025 Overview The fiscal year ended December 31, 2025, was highlighted by the following events: • On January 8, 2025, we announced the appointment of renowned retina specialist and industry pioneer Reginald J.
DURAVYU™ 2.7mg demonstrated a +7.1 letter BCVA gain and 68 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 best-in-class potential for DURAVYU™ in serious retinal diseases.
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.
The Company sold 14,636,363 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock. The shares of common stock were sold at a public offering price of $11.00 per share.
During the year ended December 31, 2024, we completed an underwritten public offering with gross proceeds of $161.0 million. The Company sold 14,636,363 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock.
The terms of the license agreement may include payment to us of non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. We recognize revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer.
License and collaboration agreement revenue — We analyze each element of our license and collaboration arrangements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales.
This increase was partially offset by $1.3 million reduction in professional fees in 2024 compared to 2023. Interest (Expense) Income Interest income from investments in marketable securities and institutional money market funds increased by $8.1 million, to $15.1 million for 2024 compared to $6.9 million for 2023.
General and Administrative General and administrative expenses decreased by $0.7 million, or 1%, to $51.6 million for 2025 from $52.4 million for 2024. Interest (Expense) Income Interest income from investments in marketable securities and institutional money market funds decreased by $3.3 million, to $11.8 million for 2025 compared to $15.1 million for 2024.
Please refer to Note 3 for further details on the license and collaboration agreements into which we have entered and corresponding amounts of revenue recognized for the years ended December 31, 2024 and 2023. 70 Recognition of Expense in Outsourced Clinical Trial Agreements We record accruals for estimated ongoing research and development costs, including costs with respect to outsourced agreements for clinical trials with contract research organizations (CROs).
Recognition of Expense in Outsourced Clinical Trial Agreements We record accruals for estimated ongoing research and development costs, including costs with respect to outsourced agreements for clinical trials with contract research organizations (CROs).
During the year ended December 31, 2023, we sold 15,294,116 shares in the December 2023 underwritten stock offering for gross proceeds of $230.0 million, and we sold 902,769 shares of our Common Stock utilizing our at-the-market facility (ATM) at a weighted average price of $11.05 per share for gross proceeds of approximately $10.0 million.
Also during the year ended December 31, 2025, we sold 825,844 shares of our common stock under the ATM facility at a weighted average price of $14.10 per share for gross proceeds of approximately $11.6 million. Share issue costs, including sales agent commissions, totaled approximately $0.5 million.
This increase was due primarily to an increase in cash invested in 72 marketable securities. We anticipate a decrease in interest income in immediate future periods due to lower interest earned on our cash and investment balances due to a general decrease in market interest rates.
This decrease was primarily attributable to general decrease in market interest rates and lower cash available for investment in marketable securities.
Operating cash inflows for the year ended December 31, 2023, totaled $1.9 million, primarily due to our net loss of $70.8 million reduced by $13.8 million of non-cash expenses, which included $12.1 million of stock-based compensation, $1.3 million of loss on extinguishment of debt, and $0.7 million for the provision of excess and obsolete inventory.
Operating cash outflows for the year ended December 31, 2024, totaled $126.2 million, primarily due to our net loss of $130.9 million offset by $32.4 million of non-cash expenses, which primarily included $36.7 million of stock-based compensation, partially offset by $5.9 million for amortization of discount on available for sale of marketable securities.
This was further offset by changes in working capital of $58.9 million, including $44.5 million of deferred revenue related to the agreement to license YUTIQ ® product rights to ANI, and $14.4 million of other working capital changes.
Non-cash expense primarily included $27.9 million of stock-based compensation, partially offset by $4.8 million for amortization of discount on available for sale of marketable securities. The change in working capital included $28.6 million of deferred revenue related to the agreement to license YUTIQ ® product rights to ANI and $5.2 million in other working capital adjustments.
Results of Operations Years Ended December 31, 2024 and 2023 (in thousands except percentages) Year ended December 31, Change 2024 2023 Amounts % Revenues: Product sales, net $ 3,164 $ 14,232 $ (11,068 ) -78 % License and collaboration agreements 38,496 30,797 7,699 25 % Royalty income 1,613 989 624 63 % Total revenues 43,273 46,018 (2,745 ) -6 % Operating expenses: Cost of sales 3,712 4,632 (920 ) -20 % Research and development 132,926 64,662 68,264 106 % Sales and marketing 131 11,689 (11,558 ) -99 % General and administrative 52,358 40,102 12,256 31 % Total operating expenses 189,127 121,085 68,042 56 % Loss from operations (145,854 ) (75,067 ) (70,787 ) 94 % Other income (expense): Interest and other income, net 15,088 6,949 8,139 117 % Interest expense (14 ) (1,247 ) 1,233 -99 % Gain (loss) on extinguishment of debt — (1,347 ) 1,347 -100 % Total other income, net 15,074 4,355 10,719 246 % Net loss before income taxes $ (130,780 ) $ (70,712 ) $ (60,068 ) 85 % Provision for income taxes $ (90 ) $ (83 ) $ (7 ) 8 % Net loss $ (130,870 ) $ (70,795 ) $ (60,075 ) 85 % Net loss per share - basic and diluted $ (2.32 ) $ (1.82 ) $ (0.50 ) 27 % Weighted average shares outstanding - basic and diluted 56,298 38,904 17,394 45 % Product Sales, net Product sales, net represents the gross sales of YUTIQ ® .
Actual results could differ from our estimates. 70 Results of Operations Years Ended December 31, 2025 and 2024 (in thousands except percentages) Year ended December 31, Change 2025 2024 Amounts % Revenues: Product sales, net $ 1,596 $ 3,164 $ (1,568 ) -50 % License and collaboration agreements 16,734 38,496 (21,762 ) -57 % Royalty income 13,041 1,613 11,428 708 % Total revenues 31,371 43,273 (11,902 ) -28 % Operating expenses: Cost of sales 2,066 3,712 (1,646 ) -44 % Research and development 221,039 132,926 88,113 66 % Sales and marketing 90 131 (41 ) -31 % General and administrative 51,610 52,358 (748 ) -1 % Total operating expenses 274,805 189,127 85,678 45 % Loss from operations (243,434 ) (145,854 ) (97,580 ) 67 % Other income (expense): Interest and other income, net 11,784 15,088 (3,304 ) -22 % Interest expense (33 ) (14 ) (19 ) 136 % Total other income, net 11,751 15,074 (3,323 ) -22 % Net loss before income taxes $ (231,683 ) $ (130,780 ) $ (100,903 ) 77 % Provision for income taxes $ (279 ) $ (90 ) $ (189 ) 210 % Net loss $ (231,962 ) $ (130,870 ) $ (101,092 ) 77 % Net loss per share - basic and diluted $ (3.17 ) $ (2.32 ) $ (0.85 ) 37 % Weighted average shares outstanding - basic and diluted 73,251 56,298 16,953 30 % Product Sales, net Product sales, net decreased by $1.6 million, or 50%, to $1.6 million for 2025 compared to $3.2 million for 2024.
Product sales, net decreased by $11.1 million, or 78%, to $3.2 million for 2024 compared to $14.2 million for 2023. This decrease was driven by the agreement to license YUTIQ ® product rights to ANI in May 2023.
This decrease was primarily attributable to recognition of remaining deferred revenue related to the Company’s 2023 agreement for the license of YUTIQ® product rights in the second quarter of 2025. Royalty Income Royalty income increased by $11.4 million, or 708%, to $13.0 million in 2025 compared to $1.6 million for 2024.
Our consolidated statements of historical cash flows are summarized as follows (in thousands): Year ended December 31, 2024 2023 Change Cash flows from operating activities: Net loss $ (130,870 ) $ (70,795 ) $ (60,075 ) Changes in operating assets and liabilities (27,773 ) 58,882 (86,655 ) Other adjustments to reconcile net loss to cash flows from operating activities: 32,417 13,788 18,629 Net cash (used in) provided by operating activities $ (126,226 ) $ 1,875 $ (128,101 ) Net cash (used in) provided by investing activities $ (219,355 ) $ (3,315 ) $ (216,040 ) Net cash provided by (used in) financing activities $ 164,022 $ 187,070 $ (23,048 ) Operating cash outflows for the year ended December 31, 2024, totaled $126.2 million, primarily due to our net loss of $130.9 million offset by $32.4 million of non-cash expenses, which included $36.7 million of stock-based compensation.
If adequate financing is not available if and when needed, we may delay, reduce the scope of, or eliminate research or development programs, or other new products, if any, postpone or cancel the pursuit of product candidates, or otherwise significantly curtail our operations to reduce our capital requirements and extend our cash runway. 73 Our consolidated statements of historical cash flows are summarized as follows (in thousands): Year ended December 31, 2025 2024 Change Cash flows from operating activities: Net loss $ (231,962 ) $ (130,870 ) $ (101,092 ) Changes in operating assets and liabilities (33,781 ) (27,773 ) (6,008 ) Other adjustments to reconcile net loss to cash flows from operating activities: 25,633 32,417 (6,784 ) Net cash (used in) provided by operating activities $ (240,110 ) $ (126,226 ) $ (113,884 ) Net cash (used in) provided by investing activities $ 68,580 $ (219,355 ) $ 287,935 Net cash provided by (used in) financing activities $ 173,647 $ 164,022 $ 9,625 Operating cash outflows for the year ended December 31, 2025, totaled $240.1 million, primarily due to our net loss of $232.0 million offset by $25.6 million of non-cash expenses and a change in working capital of 33.8 million.
We sold 14,636,363 shares of our common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock. The shares of common stock were sold at a public offering price of $11.00 per share. • In October 2024, we announced the grand opening of our Northbridge, MA manufacturing facility.
The Company sold 12,875,000 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,875,000 shares of common stock and, to certain investors, in lieu of common stock, PFWs to purchase 1,500,000 shares of common stock.
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DURAVYU™ is presently in Phase 3 clinical trials as a sustained delivery treatment 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 2 clinical trial for diabetic macular edema (DME).
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DURAVYU is currently being evaluated in Phase 3 pivotal trials (LUGANO and LUCIA) for wet age-related macular degeneration (wet AMD) and in Phase 3 clinical trials (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.
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Fiscal 2024 Overview The fiscal year ended December 31, 2024, was highlighted by the following events: • In March 2024, we announced the appointment of Ramiro Ribeiro, M.D., Ph.D. as Chief Medical Officer. Dr.
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EyePoint is headquartered in Watertown, Massachusetts with 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) and pro-inflammatory interleukin 6 (IL-6)/JAK1 signaling for at least six months.
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Ribeiro is a trained retinal specialist and joins EyePoint from Apellis Pharmaceuticals, where he served as Vice President, Head of Clinical Development. • On April 23, 2024, an end of Phase 2 meeting was held with the Food and Drug Administration (FDA) to discuss our proposed phase 3 (pivotal) clinical program for wet AMD indication. • On June 26, 2024, we hosted an R&D Day in New York City, featuring presentations from EyePoint’s management team as well as key opinion leader (KOL) guest speakers.
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Vorolanib has also demonstrated neuroprotection in an in-vivo model of retinal detachment. DURAVYU is currently 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 data expected beginning in mid-2026.
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R&D day highlights included: o Phase 3 plans for DURAVYU™ in wet AMD, including key design elements of the Phase 3 LUGANO and LUCIA pivotal trials o Positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial evaluating DURAVYU™ for the treatment of wet AMD o The VERONA trial, a Phase 2 trial of DURAVYU™ in DME patients has completed enrollment with 27 patients • In July 2024, Marcia Sellos-Moura, formerly SVP, Program Leadership, assumed a new position as SVP, Head of Development and Program Management, continuing to report to Dr.
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The first patient was dosed in the Phase 3 DME program in February 2026. We announced enrollment was completed in the pivotal Phase 3 LUGANO and LUCIA clinical trials evaluating DURAVYU on May 27, 2025 and July 29, 2025, respectively.
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Jay S. Duker, President and CEO of the Company. In her expanded role, Dr.
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Sanders, M.D., FASRS to the Company’s Board of Directors. • On March 18, 2025, ANI announced that it completed the buyout of its 3.125% perpetual royalty obligation to SWK on worldwide net revenues of ILUVIEN ® and YUTIQ ® for a one-time payment of $17.25 million.
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Sellos-Moura will manage both the R&D and Product Development teams in addition to Program Management. • On September 3, 2024, we announced the appointment of esteemed industry leader Fred Hassan to our Board of Directors. • On October 31, 2024, we completed an underwritten public offering with gross proceeds of $161.0 million.
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Under the terms of the agreement, upon making the buyout payment, no further royalty is due to SWK on net revenues beginning January 1, 2025, forward. As a result, the Company terminated the RPA effective March 18, 2025. • On October 14, 2025, we entered into an underwriting agreement (Underwriting Agreement) with J.P.
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The 40,000 square foot Good Manufacturing Process (cGMP) compliant commercial manufacturing facility was built to meet U.S. FDA and 67 European Medicines Agency (EMA) and will support global manufacturing across our portfolio, including lead pipeline asset, DURAVYU™ upon potential regulatory approval.
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Morgan Securities LLC, Jefferies LLC, Citigroup Global Markets Inc. and Guggenheim Securities, LLC, as representatives of the underwriters named therein (Underwriters), in connection with an underwritten public offering (Offering) of 11,000,000 shares (Shares) of common stock, par value $0.001 per share (Common Stock) and, to certain investors, in lieu of Common Stock, pre-funded warrants (PFWs) to purchase 1,500,000 shares of Common Stock.
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R&D Highlights • In February 2024, we announced results from new subgroup analyses from the Phase 2 DAVIO 2 clinical trial of DURAVYU™.
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The price to the public for the Shares in the Offering was $12.00 per Share and the price to the public for the PFWs was $11.999 per PFW, which represents the price to the public for the Shares less the $0.001 per share exercise price for each such PFW. The Offering closed on October 16, 2025.
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The presented analyses of the data reveal: in the sub-group of patients who were supplement-free up to 6 months, the DURAVYU™ groups demonstrated numerical superiority in change in BCVA along with strong anatomic control compared to the aflibercept control group.
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In addition, under the terms of the Underwriting Agreement, we also granted the Underwriters an option to purchase up to an additional 1,875,000 shares of Common Stock at the same price, which was 67 exercised and closed on October 30, 2025.
Removed
This result confirms that the positive topline data from the Phase 2 DAVIO 2 trial were driven by DURAVYU™ and not by study eyes requiring supplemental injection; visual and anatomical outcomes were not meaningfully influenced by differences in patient baseline BCVA, duration of wet AMD diagnosis, or historical treatment burden; and DURAVYU™ outcomes are consistent and durable in a range of wet AMD patient types. • In May 2024, we announced topline results of our Phase 2 PAVIA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR).
Added
The net proceeds from the Offering were approximately $162.1 million, after deducting underwriting discounts and commissions and before other estimated offering expenses payable by us. R&D Highlights • In February 2025, we announced positive six-month results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU.
Removed
The data demonstrated that DURAVYU™ has a biologic effect in patients with NPDR with a favorable safety and tolerability profile, however the trial did not meet the pre-specified primary endpoint.
Added
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. • The Phase 2 VERONA clinical trial of DURAVYU in DME met both primary and secondary endpoints.
Removed
The Company has no plans to further advance DURAVYU™ in NPDR. • In May 2024, we completed enrollment in the VERONA trial, a Phase 2 trial of DURAVYU™ in DME patients. The trial enrolled 27 patients with topline data anticipated in the first quarter of 2025. • In June 2024, we announced alignment on pathway to approval with U.S.
Added
The 24-week data demonstrated a meaningful and sustained improvement in vision and anatomical control with a continued favorable safety profile. • A subgroup analyses of supplement-free patients from the VERONA trial in DME demonstrated that DURAVYU 2.7mg significantly and rapidly (by week 4) improved vision and reduced fluid levels, demonstrating a BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control and a CST improvement of 117.4 microns versus 43.7 microns for aflibercept control at week 24.
Removed
Food and Drug Administration (FDA) based on positive End of Phase 2 meeting in April 2024 for two non-inferiority trials, 6-month redosing of DURAVYU™ and sham for masking with a one-year endpoint.
Added
These results further underscore the differentiated profile of DURAVYU with compelling efficacy date, a favorable safety profile, and strong durability data. • Presented multiple datasets at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in early May 2025, demonstrating DURAVYU’s potential real-world application in multiple retinal disease indications and de-risked trial designs that we believe position DURAVYU for clinical and commercial success.
Removed
Each trial is expected to enroll approximately 400 patients with active wet AMD, including previously treated and treatment naïve patients, randomly assigned to either a 2.7mg dose of DURAVYU™ or an on-label aflibercept control. All patients to receive three monthly loading doses of aflibercept prior to DURAVYU™ with randomization occurring on Day 1.
Added
Presentations included: o An assessment of the treatment burden in wet AMD treated with DURAVYU versus aflibercept from the Phase 2 DAVIO 2 clinical trial o Trial design of the global LUGANO and LUCIA pivotal Phase 3 trials in wet AMD o A 24-month Good Laboratory Practice (GLP) repeat-dose toxicology study of vorolanib intravitreal insert • The 24-week topline results from the Phase 2 VERONA study in DME were accepted for presentation at the Retina World Congress in May 2025, which highlighted DURAVYU’s potential to transform the treatment landscape in the second largest retinal disease market with its potential best-in-class safety and efficacy profile. • On July 29, 2025, we announced enrollment was now completed in both of our pivotal Phase 3 trials for DURAVYU in wet AMD. • On October 14, 2025 we announced details for our pivotal Phase 3 program evaluating DURAVYU for the treatment of DME with first patient dosing anticipated in first quarter of 2026.
Removed
The LUGANO (US) trial remains on track to randomize patients for inclusion in 2024 with LUCIA (US/ex-US) to follow. • In June 2024, we announced positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial evaluating DURAVYU™ for the treatment of wet AMD. • In August 2024, we presented on sustained-release vorolanib highlighting selective pan-VEGF receptor inhibition and anti-angiogenic effects in VEGF-mediated ocular diseases at the American Retina Forum (ARF) 2024 National Meeting demonstrating the durable efficacy, reliable safety and reduced injection burden of treatment with DURAVYU™. • In September 2024, we presented a comparison of tyrosine kinase inhibitors being developed for intravitreal delivery at the Retina Society 57th Annual Meeting, demonstrating the differentiation of DURAVYU™ with immediate bioavailability and controlled release via zero-order kinetics for at least six months. • In October 2024, we announced positive interim 16-week data for the ongoing open label Phase 2 VERONA clinical trial of DURAVYU™ for DME.
Added
In this announcement we shared new preclinical data that demonstrates vorolanib, the active drug in DURAVYU, inhibits interleukin-6 (IL-6) mediated inflammation through inhibition of all Janus Kinase (JAK) receptors, in particular JAK-1, in addition to known blockage of vascular endothelial growth factor (VEGF) mediated vascular permeability.
Removed
DURAVYU™ 2.7mg demonstrated an early, sustained, and clinically meaningful improvement in BCVA and anatomical control as measured by optical coherence tomography (OCT) versus the aflibercept control arm. Notably, both DURAVYU™ doses showed an immediate benefit over aflibercept control in both BCVA and CST demonstrating the differentiated drug release profile of DURAVYU™ with immediate bioavailability.
Added
This finding reinforces the early and sustained improvements observed through six months in the Phase 2 VERONA clinical trial and positions DURAVYU as a potential multi-mechanism of action (MOA) treatment.
Removed
Additionally, a favorable safety and tolerability profile continued for both DURAVYU™ arms. • In October 2024, we announced first patient dosed in the Phase 3 LUGANO clinical trial of DURAVYU™ in wet AMD. Subsequently, in December 2024, we announced the first patient dosed in the second Phase 3 LUCIA clinical trial of DURAVYU™ in wet AMD.
Added
Recent Developments • On February 18, 2026, we announced the appointment of Michael Campbell as Chief Commercial Officer. • On March 2, 2026, we announced the first patients dosed in both Phase 3 COMO and CAPRI global clinical trials of DURAVYU for the treatment of DME. • In the first quarter of 2026, we reached an agreement in principle with the DOJ to settle matters related to the DOJ investigation into certain of our sales, marketing and promotional practices as pertain to DEXYCU during the period for which we commercialized this product.
Removed
The LUGANO and LUCIA clinical trials are designed for potential global regulatory and commercial success with every six-month re-dosing in both trials.
Added
The agreement in principle is for a payment of approximately $4.7 million plus interest (exclusive of attorneys’ fees payable by us to counsel for relators in the qui tam action which are expected to be at or about $0.2 million), with such agreement in principle subject to our reaching an agreement in principle with the Office of Inspector General of the Department of Health and Human Services (HHS).
Removed
With over 160 trial sites committed and robust DAVIO 2 data the company anticipates rapid enrollment of both trials with topline data anticipated in 2026. • In October 2024, we presented DAVIO 2 twelve-month data at the American Academy of Ophthalmology (AAO) 2024 Subspecialty Day, at the 24th EURetina Congress in September and the Retina Society 57th Annual Meeting in September. • In February 2025, we announced positive six-month results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU™.
Added
On February 26, 2026, we reached an 68 agreement in principle with HHS to resolve matters related to the DOJ investigation on terms to include us entering into a corporate integrity agreement and HHS agreeing not to seek our exclusion from participation in Medicare, Medicaid, or other federal health care programs.
Removed
Sanders, M.D., FASRS to the Company’s Board of Directors. • In February 2023, we entered into a research collaboration with RallyBio Corporation to evaluate sustained delivery of their inhibitor of complement component 5 (C5) using our proprietary Durasert E ™ technology for sustained intraocular drug delivery. The Company and Rally Bio terminated their research collaboration in Q1 of 2025.
Added
The agreements in principle are subject to negotiation, completion and execution of appropriate documents resolving these matters, including a settlement agreement and a corporate integrity agreement, which are expected to be finalized in the first half of 2026, and the final approval of the respective parties.
Removed
Product sales, net — Effective January 2023, commercial sales of DEXYCU ® were no longer supported by the Company, remaining available only through specialty distributors. Effective May 2023, YUTIQ ® has been and continues to be sold under commercial supply agreements with Alimera Sciences, Inc. (Alimera) and Ocumension Therapeutics (Ocumension). On September 16, 2024, ANI Pharmaceuticals, Inc.
Added
We recognize revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer.
Removed
(ANI) announced the completion of the acquisition of Alimera. The acquisition does not impact the terms of the commercial supply agreements (see Note 3).
Added
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 License and collaboration agreement revenues decreased by $21.8 million, to $16.7 million in 2025 compared to $38.5 million for 2024.
Removed
The current supply agreement between the Company and ANI for the supply of YUTIQ ® will not renew and, effective June 1, 2025, the Company will no longer be responsible for manufacturing of YUTIQ ® for the U.S. market. Reserves for variable consideration — Product sales were recorded at the wholesale acquisition costs, net of applicable reserves for variable consideration.
Added
The increase in royalty income recognized was due mainly to the recognition of the remaining $12.7 million of deferred SWK royalty income. On March 18, 2025, ANI announced that it completed the buyout of its 3.125% perpetual royalty obligation to SWK on worldwide net revenues of ILUVIEN ® and YUTIQ ® for a one-time payment of $17.25 million.
Removed
Components of variable consideration included trade discounts and allowances, provider chargebacks and discounts, payor rebates, product returns, and other allowances that were offered within contracts between us and our Distributors, payors, and other contracted purchasers relating to our product sales.
Added
Under the terms of the agreement, upon making the buyout payment, no further royalty is due to SWK on net revenues beginning January 1, 2025, forward. As a result, the Company terminated the RPA effective March 18, 2025. 71 Cost of Sales Cost of sales decreased by $1.6 million, to $2.1 million for 2025 compared to $3.7 million for 2024.
Removed
These reserves were based on the amounts earned, or to be 69 claimed on the related sales, and were classified either as reductions of product revenue and accounts receivable or a current liability, depending on how the amount was to be settled.
Added
This decrease was primarily attributable to lower commercial product sales year over year.

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