EYPT Filings — Eyepoint, Inc.

EYPT Filings — Eyepoint, Inc. - FilingSpy

10-Q · Quarter ended Jun 30, 2026 · SEC filing ↗

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Original filing text

Management's Discussion and Analysis

Note Regarding Forward-Looking Statements Various statements made in this Quarterly Report on Form 10-Q are forward-looking and involve risks and uncertainties. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements give our current expectations or forecasts of future events and are not statements of historical or current facts. These statements include, among others, statements about: •the potential for DURAVYU™, as an investigational sustained delivery intravitreal treatment deploying a bioerodible Durasert E™ insert of vorolanib, a selective and patented tyrosine kinase inhibitor (TKI) targeting wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME); •the potential of DURAVYU's multi-mechanism of action to deliver a synergistic anti-inflammatory effect alongside its established VEGF receptor and PDGF receptor inhibition in the treatment of wet AMD and DME; •our expectations regarding the timing and outcome of our ongoing clinical trials for DURAVYU for the treatment of wet AMD and DME; •our expectations regarding the timing and outcome of our planned regulatory communication and interactions with the U.S. Food and Drug Administration (FDA) and comparable regulatory bodies; •our expectations regarding the timing and clinical development of our other pipeline product candidates; •our belief that our cash, cash equivalents, and investments in marketable securities of $180.5 million at June 30, 2026, will enable us to fund operations into the fourth quarter of 2027, beyond Phase 3 wet AMD topline data for DURAVYU expected in 2026; •our expectations regarding our future expenses and capital expenditures; •our expectations regarding the warning letter we received from the FDA in July 2024, or the Warning Letter, pertaining to YUTIQ® manufacturing, citing alleged violations of cGMP requirements in connection with an FDA inspection at our Watertown facility in February 2024 and our fully executed plan which implemented the corrective and preventive actions required by the Warning Letter; and •our expectation that we will continue to incur significant expenses and that our operating losses and our net cash outflows to fund operations will continue for the foreseeable future. Forward-looking statements also include statements other than statements of current or historical fact, including, without limitation, all statements related to any expectations of revenues, expenses, cash flows, earnings or losses from operations, cash required to maintain current and planned operations, capital or other financial items; any statements of the plans, strategies and objectives of management for future operations; any plans or expectations with respect to product research, development and commercialization, including regulatory approvals; any other statements of expectations, plans, intentions or beliefs; and any statements of assumptions underlying any of the foregoing. We often, although not always, identify forward-looking statements by using words or phrases such as “likely”, “expect”, “intend”, “anticipate”, “believe”, “estimate”, “plan”, “project”, “forecast”, and “outlook”. The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated, or implied in our forward-looking statements: •risks and uncertainties include the timing, progress and results of our clinical development activities; •uncertainties and delays relating to communications with the FDA and the ability to obtain regulatory approval from FDA for the commercialization of DURAVYU; •the sufficiency of our existing cash resources; •our access to needed capital; •the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; •unexpected safety or efficacy data observed during clinical trials; •uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of our product candidates; •disruptions at the FDA; •changes in the regulatory and legislative environment; •changes in U.S. and international trade policies; •changes in expected or existing competition; •fluctuations in our operating results; 18 •our dependence on contract research organizations, vendors, and clinical investigators; •our ability to manufacture clinical supply of our product candidates; •our ability to manufacture commercial supply of YUTIQ® and DEXYCU® in fulfillment of our Ocumension Agreement; •the extent to which the global economic conditions, uncertainty caused by geopolitical violence and unrest and public health crises impact our business, the medical community, and the global economy; •market acceptance of our product candidates, if approved; •protection of intellectual property and avoiding intellectual property infringement; •our ability to implement corrective and preventive actions required by the Warning Letter to the satisfaction of the FDA; •our ability to comply with our obligations under the Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services; •product liability; and •other factors described in our filings with the SEC. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. The risks set forth under Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as supplemented by the risks set forth under Item 1A of this Quarterly Report on Form 10-Q, describe major risks to our business, and you should read and interpret any forward-looking statements together with these risks. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated, or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized. EYEPOINT®, DEXYCU®, Durasert®, Durasert E™, DELIVERING INNOVATION TO THE EYE® and WITH AN EYE ON PATIENTS® are our trademarks. ILUVIEN® is ANI’s trademark. We assigned our trademarks for YUTIQ to Alimera Sciences, Inc. (which was acquired by ANI) and to Ocumension Therapeutics in their respective territories. The reports we file or furnish with the SEC, including this Quarterly Report on Form 10-Q, also contain trademarks, trade names, and service marks of other companies, which are the property of their respective owners. Our Business 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. Our pipeline leverages proprietary bioerodible Durasert E™ technology (Durasert E™) for sustained intraocular drug delivery. Our lead product candidate, DURAVYU™ (a/k/a EYP-1901), is an investigational sustained delivery treatment for vascular endothelial growth factor (VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™. EyePoint is headquartered in Watertown, Massachusetts and has a commercial manufacturing facility in Northbridge, Massachusetts. DURAVYU brings a potential new multi-mechanism of action paradigm for the treatment of retinal diseases as vorolanib, the active drug in DURAVYU, acts through intracellular inhibition of all VEGF receptors, platelet-derived growth factor (PDGF) receptor, and pro-inflammatory interleukin 6 (IL-6)/JAK1 signaling. Vorolanib has also demonstrated neuroprotection in an in vivo model of retinal detachment. DURAVYU is being evaluated in Phase 3 clinical trials for the potential treatment of wet AMD and DME, the two largest retinal disease markets. Enrollment in the pivotal Phase 3 clinical trials for wet AMD is complete with initial data expected in August 2026. The first patients were dosed in both DME trials in February 2026, and enrollment completion was announced in July 2026. The initial data readout for the DME program is expected in the fourth quarter of 2027. Recent Developments •On July 13, 2026, we announced the appointment of Tarek S. Hassan, M.D., as Chief Strategic Science Officer. •On July 17, 2026 (the “Effective Date”) we entered into a settlement agreement (the “Settlement Agreement”) with the United States of America, acting through the DOJ and on behalf of HHS and the Defense Health Agency (“DHA”), acting on behalf of the TRICARE Program, and the relator named therein. Pursuant to the Settlement Agreement, we agreed, among 19 other things, to pay a settlement amount of $4,678,981.86, plus interest at a rate of 4.25% per annum from January 28, 2026 (the “Settlement Payment”). The Settlement Payment consisted of (i) $4,657,463.18 (plus interest) to be paid to the United States and (ii) $21,518.68 (plus interest) to be paid to certain participating states, in each case payable no later than 14 days after the Effective Date. In addition, we agreed to pay $166,500 for attorneys’ fees and costs to relator’s counsel no later than 60 days after the Effective Date. Conditioned upon payment of the Settlement Payment, the DOJ, OIG-HHS, DHA and the relator have agreed to release the Company and its subsidiaries from any civil or administrative monetary liability arising from the Covered Conduct (as defined in the Settlement Agreement), and the DOJ and the relator agreed to dismiss the civil action filed by the relator. In connection with the Settlement Agreement, on July 13, 2026, we entered into a Corporate Integrity Agreement (the “Corporate Integrity Agreement”) with HHS, which requires the Company to establish and maintain certain compliance programs for a five-year term, as more fully described in the Corporate Integrity Agreement. In exchange, HHS agreed not to seek the exclusion of our Company from participation in Medicare, Medicaid, or other federal health care programs as a result of the Covered Conduct. •On July 30, 2026, we announced enrollment was completed in both COMO and CAPRI, the pivotal Phase 3 trials of DURAVYU for the treatment of DME, with over 480 patients enrolled across both trials. Topline data for both DME trials are anticipated in the fourth quarter of 2027. R&D Highlights •On May 5, 2026, we presented new preclinical data at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting that further demonstrates vorolanib’s inhibition of pro-inflammatory IL-6 signaling. oThrough extensive in vitro and in vivo studies, vorolanib was identified as a potent inhibitor of JAK1, a critical transducer of IL-6 signaling. These data further highlight DURAVYU's multi-mechanism of action and its potential to deliver a synergistic anti-inflammatory effect alongside its established VEGF receptor and PDGF receptor inhibition in the treatment of wet AMD and DME. •On May 14, 2026, we announced a positive recommendation from the independent Data Safety Monitoring Committee (DSMC) following completion of its third scheduled review of the Company’s ongoing pivotal Phase 3 program evaluating DURAVYU™ for the treatment of wet AMD. •In July 2026, we delivered multiple oral presentations at the American Society of Retina Specialists (“ASRS”) Annual Meeting supporting DURAVYU’s potentially best-in-class therapeutic profile as a sustained release TKI being developed for multiple indications: oA characterization of the multi-mechanism of action of DURAVYU in retinal exudative diseases oOverview of key learnings from the Phase 2 DAVIO 2 clinical trial in wet AMD oPost-hoc analyses of patients from the Phase 2 DAVIO 2 clinical trial who met Phase 3 criteria oOverview of DME clinical program and key learnings: from the Phase 2 VERONA trial to pivotal Phase 3 •We were accepted to deliver multiple presentations at the Retina Society Annual Meeting in September, underscoring the multi-modal activity and broad treatment potential of DURAVYU and enthusiasm from the retinal community for new treatment options in multiple serious retinal diseases. This will be the first conference where LUGANO data will be presented to the retinal community. Critical Accounting Policies and Estimates The preparation of consolidated financial statements in conformity with GAAP requires that we make certain estimates, judgments, and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses. We base our estimates, judgments, and assumptions on historical experience, anticipated results, and trends, and on various other factors that we believe are reasonable under the circumstances at the time. By their nature, these estimates, judgments, and assumptions are subject to an inherent degree of uncertainty. Actual results may differ from our estimates under different assumptions or conditions. In our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, we set forth our critical accounting policies and estimates, which included revenue recognition and recognition of expense in outsourced clinical trial agreements. See Note 2 of the notes to our unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for a description of our accounting policies and estimates. 20 Results of Operations Three months ended June 30, 2026 Compared to Three months ended June 30, 2025 (In thousands except share data and percentages: Three Months Ended June 30, Change 2026 2025 Amounts % Revenues: Product sales, net $ — $ — $ — 0 % License and collaboration agreements 507 5,333 (4,826 ) -90 % Royalty income — — — 0 % Total revenues 507 5,333 (4,826 ) -90 % Operating expenses: Cost of sales — 165 (165 ) -100 % Research and development 83,614 55,498 28,116 51 % Sales and marketing 31 35 (4 ) -11 % General and administrative 14,242 11,862 2,380 20 % Total operating expenses 97,887 67,560 30,327 45 % Loss from operations (97,380 ) (62,227 ) (35,153 ) 56 % Other income (expense): Interest and other income, net 2,910 2,894 16 1 % Total other income, net 2,910 2,894 16 1 % Net loss before income taxes (94,470 ) (59,333 ) (35,137 ) 59 % Provision for income taxes — (93 ) 93 100 % Net loss $ (94,470 ) $ (59,426 ) $ (35,044 ) 59 % Net loss per share - basic and diluted $ (1.09 ) $ (0.85 ) $ (0.24 ) 28 % Weighted average shares outstanding - basic and diluted 86,543 69,926 16,617 24 % License and Collaboration Agreement License and collaboration agreement revenue decreased by $4.8 million, or 90%, to $0.5 million for the three months ended June 30, 2026 compared to the same period the prior year. This decrease was primarily driven by the recognition of remaining deferred revenue related to our 2023 agreement for the license of YUTIQ® product rights in the second quarter of 2025. Cost of Sales Cost of sales remained immaterial for the three months ended June 30, 2026 compared to the same period the prior year. Research and Development The following table summarizes our research and development expenses for the three months ended June 30, 2026 and 2025: Three Months Ended June 30, 2026 2025 Direct research and development expenses by program: DURAVYU™ $ 57,985 $ 37,349 Other direct research and development (96 ) 1,003 Unallocated expenses: Personnel (including stock based compensation) 20,832 12,703 Facilities 1,059 1,302 Other 3,834 3,141 Total research and development expenses 83,614 55,498 21 Research and development expenses increased by $28.1 million, or 51%, to $83.6 million for the three months ended June 30, 2026 compared to the same period the prior year. This increase was primarily attributable to ongoing DURAVYU Phase 3 clinical trials for wet AMD and DME and scale-up of the Northbridge commercial manufacturing facility. Sales and Marketing Sales and marketing expenses remained consistent and immaterial for the three months ended June 30, 2026 compared to the same period the prior year. General and Administrative General and administrative expenses increased by $2.4 million, or 20%, to $14.2 million for the three months ended June 30, 2026 compared to the same period the prior year. This increase was primarily attributable to increased personnel costs, including non-cash stock compensation. Interest (Expense) Income Interest (expense) income remained consistent for the three months ended June 30, 2026 compared to the same period the prior year. 22 Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025 (In thousands except share data and percentages: Six Months Ended June 30, Change 2026 2025 Amounts % Revenues: Product sales, net $ 467 $ 715 $ (248 ) -35 % License and collaboration agreements 646 16,382 (15,736 ) -96 % Royalty income 90 12,689 (12,599 ) -99 % Total revenues 1,203 29,786 (28,583 ) -96 % Operating expenses: Cost of sales 533 970 (437 ) -45 % Research and development 155,757 114,072 41,685 37 % Sales and marketing 34 70 (36 ) -51 % General and administrative 29,485 25,738 3,747 15 % Total operating expenses 185,809 140,850 44,959 32 % Loss from operations (184,606 ) (111,064 ) (73,542 ) 66 % Other income (expense): Interest and other income, net 5,254 6,536 (1,282 ) -20 % Total other income, net 5,254 6,536 (1,282 ) -20 % Net loss before income taxes $ (179,352 ) $ (104,528 ) $ (74,824 ) 72 % Provision for income taxes $ 50 $ (93 ) $ 143 -154 % Net loss $ (179,302 ) $ (104,621 ) $ (74,681 ) 71 % Net loss per share - basic and diluted $ (2.08 ) $ (1.50 ) $ (0.58 ) 39 % Weighted average shares outstanding - basic and diluted 86,272 69,847 16,425 24 % Product Sales, Net Product sales, net decreased by $0.2 million, or 35%, to $0.5 million for the six months ended June 30, 2026 compared to the same period the prior year. This decrease was primarily attributable to the termination of the ANI commercial supply agreement (CSA) in the second quarter of 2025. License and Collaboration Agreement License and collaboration agreement revenue decreased by $15.7 million, or 96%, to $0.6 million for the six months ended June 30, 2026 compared to the same period the prior year. This decrease was primarily driven by the recognition of remaining deferred revenue related to our 2023 agreement for the license of YUTIQ® product rights in the second quarter of 2025. Royalty Income Royalty income decreased by $12.6 million, or 99%, to $0.1 million for the six months ended June 30, 2026 compared to the same period the prior year. This decrease was due to the termination of the SWK royalty purchase agreement (RPA) on March 18, 2025. Cost of Sales Cost of sales decreased by $0.4 million, or 45%, to $0.5 million for the six months ended June 30, 2026 compared to the same period the prior year. This decrease was primarily attributable to lower commercial product sales year over year. 23 Research and Development The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025: Six Months Ended June 30, 2026 2025 Direct research and development expenses by program: DURAVYU™ $ 104,837 $ 79,247 Other direct research and development 509 1,988 Unallocated expenses: Personnel (including stock based compensation) 41,258 25,089 Facilities 2,050 2,198 Other 7,103 5,550 Total research and development expenses 155,757 114,072 Research and development expenses increased by $41.7 million, or 37%, to $155.8 million for the six months ended June 30, 2026 compared to the same period the prior year. This increase was primarily attributable to ongoing DURAVYU Phase 3 clinical trials for wet AMD and DME and scale-up of the Northbridge commercial manufacturing facility. Sales and Marketing Sales and marketing expenses remained consistent and immaterial for the six months ended June 30, 2026 compared to the same period the prior year. General and Administrative General and administrative expenses increased by $3.7 million, or 15%, to $29.5 million for the six months ended June 30, 2026 compared to the same period the prior year. This increase was primarily attributable to increased personnel costs, including non-cash stock compensation. Interest (Expense) Income Interest (expense) income decreased by $1.3 million, or 20%, to $5.3 million for the six months ended June 30, 2026 compared to the same period the prior year. This decrease was primarily driven by lower cash available for investment in marketable securities. Liquidity and Capital Resources We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at June 30, 2026 we had a total accumulated deficit of $1,284.3 million. Our operations have been financed primarily from sales of our equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners. Financing Activities In August 2020, we entered into an at-the-market facility (the ATM Facility) with Cantor Fitzgerald & Co (Cantor). Pursuant to the ATM Facility, we may, at our option, offer and sell shares of its common stock from time to time, through or to Cantor, acting as sales agent. We will pay Cantor a commission of 3.0% of the gross proceeds from any future sales of such shares. During the three and six months ended June 30, 2026, we sold 1,429,047 shares of common stock under the ATM Facility at a weighted average price of $14.16 per share for gross proceeds of approximately $20.2 million. Share issue costs, including sales agent commissions, totaled approximately $0.7 million. During July 2026, we sold 1,208,718 shares of common stock under the ATM Facility at a weighted average price of $14.44 per share for gross proceeds of approximately $17.5 million. Share issue costs, including sales agent commissions, totaled approximately $0.5 million. During the three and six months ended June 30, 2025, we did not sell any shares of its common stock under the ATM Facility. 24 Future Funding Requirements At June 30, 2026, we had cash, cash equivalents, and investments in marketable securities of $180.5 million. We expect that our cash and investments in marketable securities will enable us to fund our operations into the fourth quarter of 2027. Due to the difficulty and uncertainty associated with the design and implementation of clinical trials, we will continue to assess our cash and cash equivalents, investments in marketable securities, and future funding requirements. However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations. We expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for any of our product candidates, we will incur significant sales, marketing, compliance, and manufacturing expenses. We also expect to continue to incur significant costs to comply with corporate governance, internal controls, and similar requirements associated with operating as a public reporting company. Actual cash requirements could differ from management’s projections due to many factors including additional investments in research and development programs, clinical trial expenses for DURAVYU, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities. 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 for wet AMD and DME; 2.our expectations regarding the timing and clinical development of our product candidates, including DURAVYU; 3.our plans about whether, when, and how to fund and conduct additional pipeline product development programs; 4.payments we receive under any new collaboration agreements or payments expected from existing agreements; 5.whether and when we are able to enter into strategic arrangements for our products or product candidates and the nature of those arrangements; 6.the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing any patent claims; 7.the costs and timing to implement corrective and preventive actions required by the Warning Letter to the satisfaction of the FDA; 8.changes in our operating plan, resulting in increases or decreases in our need for capital; and 9.our views on the availability, timing, and desirability of raising capital. We expect to seek additional funding to sustain our future operations and while we have successfully raised capital in the past, the ability to raise capital in future periods is not assured. We do not know if additional capital will be available when needed or on terms favorable to us or our stockholders. Collaboration, licensing or other agreements may not be available on favorable terms, or at all. If we seek to sell our equity securities, we do not know whether and to what extent we will be able to do so, or on what terms. If available, additional equity financing may be dilutive to stockholders, debt financing may involve restrictive covenants or other unfavorable terms and dilute our existing stockholders’ equity, and funding through collaboration, licensing or other commercial agreements may be on unfavorable terms, including requiring us to relinquish rights to certain of our technologies or products. If adequate financing is not available if and when needed, we may delay, reduce the scope of, or eliminate research or development programs, if any, postpone or cancel the pursuit of product candidates, or otherwise significantly curtail our operations to reduce our cash requirements and extend our capital. Our condensed consolidated statements of historical cash flows are summarized as follows (in thousands): Six Months Ended June 30, 2026 2025 Change Cash flows from operating activities: Net loss $ (179,302 ) $ (104,621 ) $ (74,681 ) Changes in operating assets and liabilities 15,313 (23,795 ) 39,108 Other adjustments to reconcile net loss to cash flows from operating activities: 21,092 12,707 8,385 Net cash (used in) provided by operating activities $ (142,897 ) $ (115,709 ) $ (27,188 ) Net cash (used in) provided by investing activities $ 134,156 $ 87,861 $ 46,295 Net cash (used in) provided by financing activities $ 17,378 $ (713 ) $ 18,091 25 Operating cash outflows for the six months ended June 30, 2026 totaled $142.9 million primarily due to our net loss of $179.3 million reduced by $21.1 million of non-cash expenses, which was primarily attributable to $22.0 million of stock-based compensation. We incurred cash inflows of $15.3 million in other working capital adjustments driven primarily by increased prepaid clinical expenses. Operating cash outflows for the six months ended June 30, 2025 totaled $115.7 million primarily due to our net loss of $104.6 million reduced by $12.7 million of non-cash expenses, which included $14.7 million of stock-based compensation, partially offset by $2.9 million for amortization of discount on available for sale of marketable securities. We incurred cash outflows related to changes in working capital of $23.8 million, which included $28.6 million of deferred revenue related to the agreement to license YUTIQ® product rights to ANI offset by $4.8 million in other working capital adjustments. For the six months ended June 30, 2026, $136.4 million of net cash was provided by investing activities from the sales of marketable securities and gain on equity investments, offset by $2.2 million used for the purchase of property and equipment. For the six months ended June 30, 2025, $89.4 million of net cash was provided by the sales of marketable securities, and $1.5 million was used for the purchase of property and equipment. Net cash provided in financing activities for the six months ended June 30, 2026 totaled $17.4 million and consisted mainly of the following: (i)$19.6 million provided by net proceeds from the issuance of 1,429,047 shares of our common stock sold utilizing our ATM Facility; (ii)$1.7 million provided by the exercise of stock options and employee stock purchase plan; (iii)$3.5 million used for the settlement of stock units to satisfy statutory tax withholding; and (iv)$0.4 million used for payment of equity issue costs Net cash used in financing activities for the six months ended June 30, 2025 totaled $0.7 million and consisted mainly of the following: (i)$1.2 million used for the settlement of stock units to satisfy statutory tax withholding; (ii)$0.3 million used for payment of equity issue costs; (iii)$0.9 million provided by the exercise of stock options 26

Legal Proceedings

DOJ Subpoena As previously reported, in August 2022, we received a subpoena from the U.S. Attorney’s Office for the District of Massachusetts (DOJ), seeking production of documents related to sales, marketing, and promotional practices, including as pertain to DEXYCU®, which we commercialized from 2019 to 2023 (the “DOJ Subpoena”). More information pertaining to the DOJ Subpoena can be found in Note 12. Contingencies, to the Notes to Consolidated Financial Statements (Part I, Item 1 of this Quarterly Report on Form 10-Q). Ocular Therapeutix, Inc. On March 20, 2026, we filed a complaint (the “Complaint”) against Ocular Therapeutix, Inc. (“Ocular”) in the Middlesex County Superior Court for the Commonwealth of Massachusetts (the “Court”). The Complaint alleges, among other things, Ocular's dissemination of false or misleading representations of fact concerning our company and the clinical results of our lead product candidate, DURAVYU™ (vorolanib intravitreal insert). The Complaint asserts several causes of action against Ocular, including defamation, commercial disparagement, violation of Mass. Gen. L. c. 93A, §§ 2 and 11, and tortious interference with advantageous business relations. We are seeking injunctive relief preventing Ocular from further disseminating the false or misleading representations of fact, requiring its public retraction of the false and misleading statements, monetary damages in the amount to be determined at trial, attorneys’ fees and costs, and such other relief that the court deems just and proper. Ocular filed its answer on April 13, 2026, seeking judgment in its favor, dismissal with prejudice of all claims, award of attorneys’ fees, costs, and expenses incurred in connection with the action, and such other and further relief as the court deems appropriate. On April 13, 2026, the Court declined to impose a temporary restraining order, but convened a preliminary injunction hearing that began on May 5, 2026 and continued on July 7, 2026. The Court has taken EyePoint's motion for a preliminary injunction under advisement.

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Risk Factors

This section augments and updates certain risk factors disclosed in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2025 (the Annual Report). The following risk factors should be read together with the other risk factors disclosed in the Annual Report. In addition to the other information in this Quarterly Report on Form 10-Q, all of the risk factors should be carefully considered in evaluating us and our common stock. Any of these risks, many of which are beyond our control, could materially and adversely affect our financial condition, results of operations or cash flows, or cause our actual results to differ materially from those projected in any forward-looking statements. We may also face other risks and uncertainties that are not presently known, are not currently believed to be material, or are not identified below because they are common to all businesses. Past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future periods. For more information, see “Note Regarding Forward-Looking Statements” in this Quarterly Report on Form 10-Q. 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. The price of our common stock is highly volatile and may be affected by developments directly affecting our business, as well as by developments out of our control or not specific to us. The pharmaceutical and biotechnology industries, in particular, and the stock market generally, are vulnerable to abrupt changes in investor sentiment. Prices of securities and trading volumes of companies in the pharmaceutical and biotechnology industries, including ours, can swing dramatically in ways unrelated to, or that bear a disproportionate relationship to, our performance. 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; 28 •statements, interviews, presentations, publications or other communications by third parties, including competitors, whether accurate or inaccurate, that may be perceived as negative with respect to us, our business, our product candidates, our preclinical and clinical data, or our prospects; •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. In addition, low trading volume in our common stock may increase their price volatility. Holders of our common stock may not be able to liquidate their positions at the desired time or price. We have initiated legal proceedings and may in the future become subject to litigation, which could harm our business, financial condition, stock price and reputation. We are involved, and may become involved in the future, in disputes and other legal proceedings that could be costly and time-consuming to prosecute or defend and result in unfavorable outcomes, which may have a material adverse effect on our business, operating results and financial condition, and negatively affect the price of our common stock. For example, on March 20, 2026, we filed a complaint against Ocular Therapeutix, Inc. (“Ocular”), in the Middlesex County Superior Court for the Commonwealth of Massachusetts. The complaint alleges, among other things, Ocular’s dissemination of false or misleading representations of fact concerning our company and the clinical results of DURAVYU, our lead product candidate (the “Ocular Litigation”). The complaint asserts several causes of action against Ocular, including defamation, commercial disparagement, violation of Mass. Gen. L. c. 93A, §§ 2 and 11, and tortious interference with advantageous business relations. We are seeking injunctive relief preventing Ocular from further disseminating the false or misleading representations of fact, requiring its public retraction of the false and misleading statements, monetary damages in the amount to be determined at trial, attorneys’ fees and costs, and such other relief that the court deems just and proper. Ocular filed its answer on April 13, 2026, seeking judgment in its favor, dismissal with prejudice of all claims, award of attorneys’ fees, costs, and expenses incurred in connection with the action, and such other and further relief as the court deems appropriate. We cannot predict whether the Ocular Litigation or any future legal matter will be resolved favorably for us. Legal proceedings in general, regardless of their merits or their ultimate outcomes, can be expensive and time-consuming to bring or defend against, requiring us to expend significant resources and divert the effort and attention of our management and other personnel from our business operations. The Ocular Litigation and any future litigation may adversely affect our business, results of operations, financial condition, prospects, and stock price. Furthermore, publicity surrounding legal proceedings, even if resolved favorably for us, could result in additional legal proceedings, damage to our reputation and cause volatility in our stock price.