EYPT

EyePoint, Inc.

NASDAQ · TECHNOLOGY · LABORATORY ANALYTICAL INSTRUMENTS

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USD · close Oct 27

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MKT CAP $33.1MP/E —DIV YIELD —FCF YIELD -820.08%REV TTM $2.8M −94.6%NET INCOME −$306.6MNET CASH $80.5M52W 0.37 – 18.85SEC XBRL · TTM TO Invalid Date

How EYPT rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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Risk Factors” in this Annual Report on Form 10-K for the year ended December 31, 2025.
If we are unable to obtain sufficient capital, we will need to curtail and reduce our operations and costs and modify our business strategy. • We have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. • We may never achieve profitability from future operations. • If we are unable to reach a final negotiated resolution with the U.S. government related to DOJ investigation, the DOJ may commence an action against us, which could have a material adverse effect on our business, financial condition, results of operations, and cash flows.
In addition, even if we finalize a negotiated resolution, we may be required to expend significant additional financial and managerial resources to comply with such agreement, including a corporate integrity agreement. • We will need to raise additional capital in the future, which may not be available on favorable terms and may be dilutive to stockholders or impose operational restrictions. • Our ability to use our net operating loss carryforwards and other tax attributes may be limited.
Our failure to comply with these laws could expose us to criminal, civil and administrative sanctions, reputational harm, and could harm our results of operations and financial conditions. • If the market opportunities for our product candidates, including DURAVYU, are smaller than we believe they are, our results of operations may be adversely affected and our business may suffer. • If any of our product candidates have newly discovered or developed safety problems, our business would be seriously harmed. • Patient assistance programs for pharmaceutical products have come under increasing scrutiny by governments, legislative bodies and enforcement agencies.
Risks Related To Our Intellectual Property • If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate to protect our product candidates, our competitors could develop and commercialize technology and products similar to ours, and our competitive position could be harmed. • We may become involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful. • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which could be uncertain and could harm our business. • Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. • Changes in either U.S. or foreign patent law or interpretation of such laws could diminish the value of patents in general, thereby impairing our ability to protect our products or product candidates.
If we breach our agreement with Equinox or the agreement is terminated, we could lose license rights or API supply of vorolanib that are material to our business. • The development of our lead product candidate, DURAVYU, is dependent on our supply of API vorolanib, which we currently source from a sole supplier.
We intend to negotiate and enter into a commercial supply agreement for vorolanib.
If we are unable to enter into a long-term arrangement with a manufacturer or the manufacturer or partner we rely upon fails to supply vorolanib in the amounts we require on a timely basis, or fails to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may be unable to meet demand for our products and may lose potential revenues. • If our Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), Contract Development Manufacturing Organizations (CDMOs), vendors, and investigators do not successfully carry out their responsibilities or if we lose our relationships with them, our development efforts with respect to our product candidates could be delayed. • 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. • Our manufacturing operations currently depend on our Watertown, MA and Northbridge, MA facilities.
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. • A small concentration of approximately ten stockholders beneficially own 62% of our total outstanding common stock, which gives certain stockholders significant control over matters subject to stockholder approval, which would prevent new investors from influencing significant corporate decisions.
(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 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.
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.
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 DRUAVYU, 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.
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.
The first patient was dosed in the Phase 3 DME program in February 2026.
Durasert ® enables the development of a solid drug cylinder that is delivered through a standard intravitreal (IVT) injection in the physician office, similar to current standard practice with FDA approved IVT treatments.
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.
The Phase 3 program was developed with feedback from both the FDA and European Medicines Agency (EMA).
We initiated the pivotal trials leveraging learnings from our robust DAVIO and DAVIO 2 clinical trials, which achieved primary and secondary endpoints.
Key characteristics of the Phase 3 wet AMD pivotal program are as follows: • Randomized, double-masked, aflibercept controlled, non-inferiority trials assessing the efficacy and safety of DURAVYU 2.7mg in patients with active wet AMD. • Trials include approximately 75% treatment-naïve and 25% previously treated patients. • The LUGANO trial enrolled 432 patients and the LUCIA trial enrolled 475 patients who were randomly assigned, 1:1, to a DURAVYU 2.7mg arm or an on-label aflibercept control arm.
Randomization occurred on Day 1. • Patients in the DURAVYU 2.7mg treatment arm will be re-dosed every six months for a total of four doses over the two-year trial. • The primary endpoint is the difference in mean change in best corrected visual acuity (BCVA) from Day 1 to Week 52 and 56 (blended) versus aflibercept control.
Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical stability.
If the wet AMD Phase 3 clinical program is successful, we plan on filing a New Drug Application (NDA) with the U.S Food and Drug Administration (FDA) with the initial 56-week efficacy and safety data.
A supplemental NDA (sNDA) is planned for the Year 2 safety data only, once complete. 1.
In DME, DURAVYU is currently being evaluated in global Phase 3 clinical trials (COMO and CAPRI).
We initiated the pivotal trials leveraging learnings from the positive Phase 2 VERONA trial, which achieved primary and secondary endpoints.
Key characteristics of the Phase 3 DME pivotal program are as follows: • Randomized, double-masked, aflibercept controlled, non-inferiority trials assessing the efficacy and safety of DURAVYU 2.7mg in patients with active DME. • Each trial will enroll approximately 240 patients, including both previously treated and treatment naïve patients, who will be randomly assigned to either a DURAVYU 2.7mg arm or an on-label 2mg aflibercept control arm.
Randomization occurs on Day 1. • Each trial plans to enroll approximately 75% treatment-naïve and 25% previously treated patients. • Patients in the DURAVYU 2.7mg treatment arm will be re-dosed every six months for a total of four doses over the two-year trial. • The primary endpoint is the difference in mean change in BCVA from Day 1 to Week 52 and 56 (blended) versus aflibercept control.
DURAVYU Clinical Development and Pipeline Progress – During 2025, we achieved significant clinical and regulatory milestones for DURAVYU, our lead product candidate for the treatment of major retinal diseases, including DME and wet AMD .
Clinical Milestones in DME – On February 2, 2025, we announced that the Phase 2 VERONA clinical trial of DURAVYU in DME met its primary and secondary endpoints.
Data at 24 weeks demonstrated meaningful and sustained improvements in visual acuity and anatomical control with a favorable safety profile.
Notably, a subgroup analysis of supplement-free patients receiving the DURAVYU 2.7mg dose showed rapid visual improvement (+10.3 letters vs. +3.0 letters for aflibercept control) and significant reduction in CST (117.4 microns vs. 43.7 microns for control) by week 24.
Building on these results, in October 2025, we finalized the design for our pivotal Phase 3 program in DME, with the first patient dosed in the first quarter of 2026.
Pivotal Phase 3 Program in Wet AMD – We made substantial progress in our wet AMD Phase 3 program during 2025.

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Gone since FY2024

Risk Factors” in this Annual Report on Form 10-K for the year ended December 31, 2024.
If we are unable to obtain sufficient capital, we will need to curtail and reduce our operations and costs and modify our business strategy. • We have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. • We may never achieve profitability from future operations. • We received a subpoena from the U.S.
Attorney’s Office for the District of Massachusetts seeking production of documents related to sales, marketing and promotional practices, including as pertain to DEXYCU ® .
If the DOJ commences an action against us, the action could have a material adverse effect on our business, financial condition, results of operations, and cash flows.
In addition, we have expended and expect to continue to expend significant financial and managerial resources responding to the DOJ Subpoena, which could also have a material adverse effect on our business, financial condition, results of operations and cash flows. • We will need to raise additional capital in the future, which may not be available on favorable terms and may be dilutive to stockholders or impose operational restrictions. • Our ability to use our net operating loss carryforwards and other tax attributes may be limited.
Our failure to comply with these laws could expose us to criminal, civil and administrative sanctions, reputational harm, and could harm our results of operations and financial conditions. • If the market opportunities for our product candidates, including DURAVYU, are smaller than we believe they are, our results of operations may be adversely affected and our business may suffer. • If any of our products have newly discovered or developed safety problems, our business would be seriously harmed.
Risks Related To Our Intellectual Property • If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate to protect our product candidates, our competitors could develop and commercialize technology and products similar to ours, and our competitive position could be harmed. • We may become involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful. • We may not be able to protect our intellectual property rights throughout the world. • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which could be uncertain and could harm our business. • Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. • Changes in either U.S. or foreign patent law or interpretation of such laws could diminish the value of patents in general, thereby impairing our ability to protect our products or product candidates. • We may be subject to claims asserting that our employees, consultants, independent contractors, and advisors have wrongfully used or disclosed confidential information and/or alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property. • Intellectual property rights do not prevent all potential threats to competitive advantages we may have. • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. • If our trademarks are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
If we breach our agreement with Equinox or the agreement is terminated, we could lose license rights or API supply of vorolanib that are material to our business. • The development of our lead product candidate, DURAVYU, is dependent on our supply of API vorolanib, which we source from third-parties.
If any manufacturer or partner we rely upon fails to supply vorolanib in the amounts we require on a timely basis, or fails to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may be unable to meet demand for our products and may lose potential revenues. • If our Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), Contract Development Manufacturing Organizations (CDMOs), vendors, and investigators do not successfully carry out their responsibilities or if we lose our relationships with them, our development efforts with respect to our product candidates could be delayed. • 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. • Our manufacturing operations currently depend on our Watertown, MA and Northbridge, MA facilities.
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. • A small concentration of approximately ten stockholders beneficially own 67% of our total outstanding common stock, which gives certain stockholders significant control over matters subject to stockholder approval, which would prevent new investors from influencing significant corporate decisions.
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 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.
Due to the drawbacks of frequent intravitreal injections, we believe the delivery of drugs to patients in a more precise, zero order release kinetics over longer periods of time with Durasert ® can satisfy a large unmet medical need for both patients and physicians.
Further, we are focused on bringing a new mechanism of action to the treatments of disease in addition to the current standard of care.
Unlike many chronic diseases that are treated with drugs addressing multiple mechanisms of action, most retinal diseases are currently addressed using a single mechanism of action.
DURAVYU has the potential to bring a new mechanism of action and treatment paradigm for VEGF mediated retinal diseases as vorolanib acts through intracellular binding of all VEGF receptors thereby blocking all VEGF isoforms.
Vorolanib has also demonstrated encouraging neuroprotection data in preclinical in-vivo studies potentially bringing an additional treatment benefit.
DURAVYU is currently in Phase 3 global, clinical trials 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 recently completed a positive Phase 2 clinical trial for diabetic macular edema (DME).
Additional pipeline programs include EYP-2301, a promising TIE-2 agonist, razuprotafib, f/k/a AKB-9778, formulated in Durasert E to potentially improve outcomes in serious retinal diseases.
EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
Our Durasert ® technology provides for the development of a miniaturized solid cylinder of drug that can be delivered through a standard intravitreal (IVT) injection in the physician office, similar to current standard practice with FDA approved anti-VEGF treatments.
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).
We initiated the pivotal trials leveraging learnings from our robust DAVIO and DAVIO 2 clinical trials, which achieved all primary and secondary endpoints.
Key elements from the LUGANO and LUCIA clinical trials include: • Both are global, randomized, double-masked, aflibercept controlled, non-inferiority Phase 3 trials assessing the efficacy and safety of DURAVYU in patients with active wet AMD including previously treated and treatment-naïve patients. • Each trial is expected to enroll approximately 400 patients who will be randomly assigned 1:1 to a 2.7mg dose of DURAVYU or an on-label aflibercept control. • Patients in the DURAVYU treatment arm will be re-dosed with DURAVYU every six months for a total of four injections over the two-year trial. • The primary endpoint of the Phase 3 pivotal trials is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 versus baseline.
Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections and anatomical results as measured by optical coherence tomography (OCT). • Safety evaluation only will be continued through year two of the trials.
In October 2024, we announced positive interim 16-week data for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU for patients with DME.
DURAVYU 2.7mg demonstrated an early, sustained, and clinically meaningful improvement in BCVA and anatomical control.
A favorable safety and tolerability profile continued for both DURAVYU arms.
In February 2025, we announced positive 24-week results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU.
The clinical trial met primary and key secondary endpoints its primary endpoint including extended time to first supplemental injection compared to aflibercept control for both DURAVYU doses and sustained improvement in BCVA and anatomical control.
The 24-week data also demonstrated continued safety with no DURAVYU-related ocular or systemic SAEs.
In March 2025, we presented positive 24-week supplement-free patient subgroup analyses from the Phase 2 VERONA clinical trial.
The data demonstrated that DURAVYU 2.7mg had significantly better improvement in BCVA and anatomical control compared to the aflibercept control group.
These results confirm that the positive data from the Phase 2 VERONA trial were driven by DURAVYU.
The highly positive Phase 2 data support our plans to engage in discussions with U.S. and ex-U.S. regulatory agencies to solidify the plans around the pivotal program.
In October 2024, the Company opened its new current Good Manufacturing Process (cGMP) commercial manufacturing facility in Northbridge, MA to support resupplies of clinical trial materials and global manufacturing across its portfolio, including lead pipeline asset, DURAVYU.
The 40,000 plus square-foot manufacturing facility is compliant to meet U.S.
FDA and European Medicines Agency (EMA) standards and will support DURAVYU clinical supply and commercial readiness upon potential regulatory approval.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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