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EYPT

EyePointA
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-05
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Earnings documents stored for EYPT.

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Investor releaseQuarter not tagged2026-08-05

EyePoint: Q2 Earnings Snapshot

Associated Press

WATERTOWN, Mass. (AP) — WATERTOWN, Mass. (AP) — EyePoint, Inc. (EYPT) on Wednesday reported a loss of $94.5 million in its second quarter. The Watertown, Massachusetts-based company said it had a loss of $1.09 per share. The results missed Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 92 cents per share. The drug delivery technology company posted revenue of $507,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on EYPT at https://www.zacks.com/ap/EYPT

Investor releaseQuarter not tagged2026-08-05

EyePoint Reports Second Quarter 2026 Financial Results and Highlights Recent Corporate Developments

GlobeNewswire
– Topline data from LUGANO pivotal Phase 3 wet AMD clinical trial expected in August 2026 –– – Topline data from LUCIA pivotal Phase 3 wet AMD clinical trial anticipated in Q4 2026 –– – Pivotal Phase 3 DME clinical trials, COMO and CAPRI, fully enrolled over 480 patients in 5 months; topline data expected in Q4 2027 –– – $180 million of cash and investments as of June 30, 2026, with runway into Q4 2027 –– WATERTOWN, Mass., Aug. 05, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the second quarter ended June 30, 2026, and highlighted recent corporate developments. “With topline data from our pivotal Phase 3 LUGANO wet AMD trial expected this month, followed by LUCIA in the fourth quarter, and enrollment now completed in our pivotal Phase 3 DME program, we continue to execute across our clinical programs,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “The LUGANO and LUCIA data readouts represent transformative advancement in the wet AMD landscape, potentially positioning DURAVYU as the foundational treatment option for sustained patient care.” R&D Updates: DURAVYU (vorolanib intravitreal insert) Wet Age-Related Macular Degeneration (Wet AMD) Pivotal Phase 3 wet AMD clinical trials are on track, with topline data readout for LUGANO expected in August 2026. LUCIA topline data results are expected in the fourth quarter of 2026. Diabetic Macular Edema (DME) Pivotal Phase 3 COMO and CAPRI clinical trials have completed enrollment, together enrolling over 480 patients in five months. Topline data for both DME trials are anticipated in the fourth quarter of 2027. Recent and Upcoming Presentations at Medical Conferences In May 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. 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 tyrosine kinase inhibitor (TKI) being developed for multiple indications: Accepted to deliver multiple prese…Read full document

– Topline data from LUGANO pivotal Phase 3 wet AMD clinical trial expected in August 2026 –– – Topline data from LUCIA pivotal Phase 3 wet AMD clinical trial anticipated in Q4 2026 –– – Pivotal Phase 3 DME clinical trials, COMO and CAPRI, fully enrolled over 480 patients in 5 months; topline data expected in Q4 2027 –– – $180 million of cash and investments as of June 30, 2026, with runway into Q4 2027 –– WATERTOWN, Mass., Aug. 05, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the second quarter ended June 30, 2026, and highlighted recent corporate developments. “With topline data from our pivotal Phase 3 LUGANO wet AMD trial expected this month, followed by LUCIA in the fourth quarter, and enrollment now completed in our pivotal Phase 3 DME program, we continue to execute across our clinical programs,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “The LUGANO and LUCIA data readouts represent transformative advancement in the wet AMD landscape, potentially positioning DURAVYU as the foundational treatment option for sustained patient care.” R&D Updates: DURAVYU (vorolanib intravitreal insert) Wet Age-Related Macular Degeneration (Wet AMD) Pivotal Phase 3 wet AMD clinical trials are on track, with topline data readout for LUGANO expected in August 2026. LUCIA topline data results are expected in the fourth quarter of 2026. Diabetic Macular Edema (DME) Pivotal Phase 3 COMO and CAPRI clinical trials have completed enrollment, together enrolling over 480 patients in five months. Topline data for both DME trials are anticipated in the fourth quarter of 2027. Recent and Upcoming Presentations at Medical Conferences In May 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. 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 tyrosine kinase inhibitor (TKI) being developed for multiple indications: 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. Recent Corporate Highlight In July 2026, Tarek S. Hassan, M.D., was appointed as Chief Strategic Science Officer. A globally recognized retina specialist and key opinion leader with more than 35 years of experience, Dr. Hassan provides strategic guidance across the Company’s portfolio to optimize development, potential commercialization, and growth opportunities. Review of Results for the Second Quarter Ended June 30, 2026 For the quarter ended June 30, 2026, total net revenue was $0.5 million compared to $5.3 million for the corresponding period in 2025. The decrease was primarily driven by the recognition of remaining deferred revenue related to the Company’s 2023 agreement for the license of YUTIQ® product rights. Operating expenses for the quarter ended June 30, 2026, totaled $97.9 million versus $67.6 million for the corresponding period in 2025. This increase was primarily attributable to ongoing DURAVYU Phase 3 clinical trials for wet AMD and DME and scale-up of our commercial manufacturing facility. Net non-operating income totaled $2.9 million and net loss was $94.5 million, or ($1.09) per share, compared to a net loss of $59.4 million, or ($0.85) per share, for the corresponding period in 2025. Cash, cash equivalents, and marketable securities as of June 30, 2026, totaled $180 million compared to $223 million as of March 31, 2026. Financial Outlook We expect the cash, cash equivalents, and marketable securities as of June 30, 2026, will enable us to fund operations into the fourth quarter of 2027 beyond key milestones for the Phase 3 wet AMD program in 2026. Conference Call Information In light of the upcoming topline data readout for the pivotal Phase 3 LUGANO clinical trial in wet AMD, EyePoint will not be hosting an earnings-related conference call. The Company plans to provide an update in conjunction with topline data. About EyePoint 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 lead product candidate, DURAVYU™, is an innovative investigational sustained delivery treatment for serious retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor, in next-generation bioerodible Durasert E™ technology. Supported by robust safety and efficacy data across multiple clinical trials and indications, DURAVYU is currently being evaluated in Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Topline data is expected for wet AMD beginning in August 2026 and for DME in the fourth quarter of 2027. The Company is committed to partnering with the retinal community to improve patient lives while creating long-term value, with four approved drugs over three decades and tens of thousands of eyes treated with EyePoint innovation. EyePoint is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Forward Looking Statements EYEPOINT SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our expectations regarding our clinical development and regulatory plans; our belief that DURAVYU™ is well-positioned to be the first-to-market among all investigational sustained release treatments for the two largest retinal disease markets, wet AMD and DME; our belief that DURAVYU is the only TKI in development for DME; our belief that DURAVYU is uniquely positioned to potentially address both VEGF-mediated vascular leakage and IL-6 mediated inflammatory drivers of DME as a sustained delivery therapy; our belief that DURAVYU’s potential real-world application in multiple retinal disease indications and established trial designs position DURAVYU for clinical and commercial success; our expectations regarding the timing of the availability and release of wet AMD and DME clinical data; our financial position and expected cash runway; our belief that DURAVYU has the potential to maintain a majority of patients with active disease with no supplemental anti-VEGF therapy for six months or longer; our beliefs regarding the potential market opportunity for DURAVYU in wet AMD and DME; our ability to continue to scale operations at our commercial manufacturing facility in Northbridge, Massachusetts; our expectations that our manufacturing facility will continue to meet FDA and EMA standards and support commercialization efforts of DURAVYU upon regulatory approval; and our expectations regarding the timing and clinical development of our other product candidates; and other statements regarding the Company’s future plans, objectives, strategies and beliefs, as identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” or other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the Company’s clinical development activities; uncertainties and delays relating to communications with the U.S. Food and Drug Administration and the ability to obtain regulatory approval from FDA for the commercialization of DURAVYU; unanticipated costs and expenses; the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; 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 the Company’s product candidates; changes in the regulatory environment; disruptions at the FDA; changes in U.S. and international trade policies; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates, including due to unanticipated regulatory compliance issues or warning letters relating to the Company’s manufacturing facilities; the availability of and the need for additional financing; our ability to obtain additional funding to support our clinical development programs; uncertainties regarding the FDA warning letter pertaining to the Company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. 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. A more complete discussion of the risks and uncertainties that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in our most recent Annual Report on Form 10-K, in our other filings with the Securities and Exchange Commission (SEC) and in our future reports to be filed with the SEC, which are available at www.sec.gov. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors:Robin GarnerEyePoint, [email protected] Media:Helen O’GormanFTI [email protected]

Investor releaseQuarter not tagged2026-07-29

Earnings Preview: EyePoint (EYPT) Q2 Earnings Expected to Decline

Zacks
Wall Street expects a year-over-year decline in earnings on lower revenues when EyePoint (EYPT) reports results for the quarter ended June 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This drug delivery technology company is expected to post quarterly loss of $0.92 per share in its upcoming report, which represents a year-over-year change of -8.2%. Revenues are expected to be $0.25 million, down 95.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 8.89% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A…Read full document

Wall Street expects a year-over-year decline in earnings on lower revenues when EyePoint (EYPT) reports results for the quarter ended June 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This drug delivery technology company is expected to post quarterly loss of $0.92 per share in its upcoming report, which represents a year-over-year change of -8.2%. Revenues are expected to be $0.25 million, down 95.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 8.89% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For EyePoint, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -9.39%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that EyePoint will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that EyePoint would post a loss of$0.79 per share when it actually produced a loss of -$0.99, delivering a surprise of -25.32%. The company has not been able to beat consensus EPS estimates in any of the last four quarters. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. EyePoint doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, Amgen (AMGN), is soon expected to post earnings of $5.6 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of -7%. Revenues for the quarter are expected to be $9.45 billion, up 2.9% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Amgen has been revised 0.5% up to the current level. Nevertheless, the company now has an Earnings ESP of +0.70%, reflecting a higher Most Accurate Estimate. When combined with a Zacks Rank of #4 (Sell), this Earnings ESP makes it difficult to conclusively predict that Amgen will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report EyePoint, Inc. (EYPT) : Free Stock Analysis Report Amgen Inc. (AMGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-17

Alumis Stock Has Soared 400%. Cormorant Bought Another $8 Million Last Quarter

Motley Fool
On May 15, 2026, Cormorant Asset Management disclosed a buy of 313,645 shares of Alumis (NASDAQ:ALMS), with the estimated transaction value at $7.84 million based on quarterly average pricing. According to a May 15, 2026 SEC filing, Cormorant Asset Management increased its position in Alumis by 313,645 shares during the first quarter. The firm’s estimated trade size was $7.84 million, calculated using the quarter’s average closing price. The stake’s value at quarter-end rose by $51.52 million, a figure that incorporates both buying activity and market price movements. Cormorant’s buy brings its Alumis stake to 4.37% of 13F assets as of March 31, 2026. Top holdings after the filing: NASDAQ:PRAX: $285.30 million (14.4% of AUM) NASDAQ:BBOT: $160.01 million (8.1% of AUM) NASDAQ:EYPT: $106.54 million (5.4% of AUM) NASDAQ:EWTX: $102.69 million (5.2% of AUM) NASDAQ:ERAS: $93.84 million (4.7% of AUM) As of May 14, 2026, Alumis shares were priced at $24.63, up about 400% over the past year and vastly outperforming the S&P 500’s roughly 25% gain in the same period. Alumis develops clinical-stage biopharmaceutical products targeting autoimmune and neuroinflammatory diseases, including ESK-001 and A-005, with a focus on allosteric TYK2 inhibitors. The company operates a research-driven model, advancing proprietary drug candidates through clinical trials. It targets healthcare providers and pharmaceutical partners addressing autoimmune and neurodegenerative conditions, with a primary focus on the biotechnology and healthcare sectors. Alumis is a clinical-stage biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory disorders. The company leverages its expertise in allosteric TYK2 inhibition to advance a pipeline of differentiated drug candidates. With a research-centric strategy and a focus on high unmet medical needs, Alumis aims to establish a competitive edge in the biopharmaceutical landscape. This is one of several buys Cormorant made last quarter into high-flying biotechs. With shares up roughly 400% over the past year, the fund added even more exposure, signaling confidence that the company’s late-stage autoimmune pipeline could continue driving upside from here.A lot of that optimism centers around envudeucitinib, Alumis’ oral TYK2 inhibitor for plaque psoriasis and lupus. Just last week, the c…Read full document

On May 15, 2026, Cormorant Asset Management disclosed a buy of 313,645 shares of Alumis (NASDAQ:ALMS), with the estimated transaction value at $7.84 million based on quarterly average pricing. According to a May 15, 2026 SEC filing, Cormorant Asset Management increased its position in Alumis by 313,645 shares during the first quarter. The firm’s estimated trade size was $7.84 million, calculated using the quarter’s average closing price. The stake’s value at quarter-end rose by $51.52 million, a figure that incorporates both buying activity and market price movements. Cormorant’s buy brings its Alumis stake to 4.37% of 13F assets as of March 31, 2026. Top holdings after the filing: NASDAQ:PRAX: $285.30 million (14.4% of AUM) NASDAQ:BBOT: $160.01 million (8.1% of AUM) NASDAQ:EYPT: $106.54 million (5.4% of AUM) NASDAQ:EWTX: $102.69 million (5.2% of AUM) NASDAQ:ERAS: $93.84 million (4.7% of AUM) As of May 14, 2026, Alumis shares were priced at $24.63, up about 400% over the past year and vastly outperforming the S&P 500’s roughly 25% gain in the same period. Alumis develops clinical-stage biopharmaceutical products targeting autoimmune and neuroinflammatory diseases, including ESK-001 and A-005, with a focus on allosteric TYK2 inhibitors. The company operates a research-driven model, advancing proprietary drug candidates through clinical trials. It targets healthcare providers and pharmaceutical partners addressing autoimmune and neurodegenerative conditions, with a primary focus on the biotechnology and healthcare sectors. Alumis is a clinical-stage biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory disorders. The company leverages its expertise in allosteric TYK2 inhibition to advance a pipeline of differentiated drug candidates. With a research-centric strategy and a focus on high unmet medical needs, Alumis aims to establish a competitive edge in the biopharmaceutical landscape. This is one of several buys Cormorant made last quarter into high-flying biotechs. With shares up roughly 400% over the past year, the fund added even more exposure, signaling confidence that the company’s late-stage autoimmune pipeline could continue driving upside from here.A lot of that optimism centers around envudeucitinib, Alumis’ oral TYK2 inhibitor for plaque psoriasis and lupus. Just last week, the company reported strong Phase 3 psoriasis data showing PASI 90 response rates above 60% and PASI 100 rates ofo about 40% by Week 24, results management said support the drug’s potential as a leading oral psoriasis therapy. Alumis also said it remains on track to submit an NDA in the fourth quarter of 2026, while potentially pivotal lupus data are expected in the third quarter.The balance sheet also gives the company flexibility. Alumis ended March with about $569.5 million in cash, cash equivalents, and marketable securities, which management says should fund operations into late 2027.As with its other buys (in Dianthus and Erasca), the opportunity is clear, but so is the risk. Expectations are now extremely high after the stock’s massive run, meaning future clinical data will matter far more than hype alone. Before you buy stock in Alumis, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Alumis wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $469,293!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,381,332!* Now, it’s worth noting Stock Advisor’s total average return is 993% — a market-crushing outperformance compared to 207% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 17, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Alumis Stock Has Soared 400%. Cormorant Bought Another $8 Million Last Quarter was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-05-07

EyePoint (EYPT) Q1 2026 Earnings Transcript

Motley Fool
Image source: The Motley Fool. Wednesday, May 6, 2026 at 8:30 a.m. ET President and Chief Executive Officer — Jay Duker, M.D. Chief Financial Officer — George Elston Chief Medical Officer — Ramiro Ribeiro, M.D. Chief Commercial Officer — Michael Campbell Need a quote from a Motley Fool analyst? Email [email protected] Jay will begin with a review of recent corporate updates and discuss our ongoing clinical programs for DURAVYU in wet AMD and DME. I will close with commentary on the first quarter 2026 financial results. We will then open the call for your questions, where we will be joined by Dr. Ramiro Ribeiro, our Chief Medical Officer; and Mike Campbell, our Chief Commercial Officer. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found in the Investor Relations tab on the company website, www.yepoint.bio. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory matters and time lines, the potential success of our products and product candidates, financial projections and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is on file with the SEC and in other filings that we have made or may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of EyePoint. Jay Duker: Thank you, George. Good morning, everyone, and thank you for joining us. The start of 2026 for EyePoint was marked by a strong quarter of consistent execution as we approach a pivotal inflection point for…Read full document

Image source: The Motley Fool. Wednesday, May 6, 2026 at 8:30 a.m. ET President and Chief Executive Officer — Jay Duker, M.D. Chief Financial Officer — George Elston Chief Medical Officer — Ramiro Ribeiro, M.D. Chief Commercial Officer — Michael Campbell Need a quote from a Motley Fool analyst? Email [email protected] Jay will begin with a review of recent corporate updates and discuss our ongoing clinical programs for DURAVYU in wet AMD and DME. I will close with commentary on the first quarter 2026 financial results. We will then open the call for your questions, where we will be joined by Dr. Ramiro Ribeiro, our Chief Medical Officer; and Mike Campbell, our Chief Commercial Officer. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found in the Investor Relations tab on the company website, www.yepoint.bio. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory matters and time lines, the potential success of our products and product candidates, financial projections and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is on file with the SEC and in other filings that we have made or may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of EyePoint. Jay Duker: Thank you, George. Good morning, everyone, and thank you for joining us. The start of 2026 for EyePoint was marked by a strong quarter of consistent execution as we approach a pivotal inflection point for our lead program, DURAVYU. We have strong conviction that the upcoming LUGANO and LUCIA readouts will catalyze our future transition into a fully integrated biopharmaceutical company, furthering our mission of improving the lives of patients with serious retinal disease. We remain on track to deliver these Phase III top line data in wet age-related macular degeneration or wet AMD, beginning mid-year, positioning us to potentially be the first to market among all current investigational sustained release programs. In Diabetic Macular Edema, or DME, we are seeing strong momentum in our Phase III program with enrollment rapidly progressing to support our ambitious goal of full enrollment in both pivotal trials in the third quarter of 2026. As we advance towards these significant milestones, we are confident that our clinically-rigorous, derisked and patient-centric approach will continue to reinforce DURAVYU's best-in-class potential in the 2 largest retinal disease markets. The fundamental strength of the DURAVYU program lies in its robust and differentiated clinical data. In Phase II trials, a single dose of DURAVYU demonstrated durable efficacy with improved vision and tight anatomic control. In over 190 patients across 4 completed clinical trials, DURAVYU has demonstrated a consistently favorable safety profile with no safety signals. That profile continues to hold in our ongoing Phase III LUGANO and LUCIA trials for wet AMD as observed on a mass basis, where our low discontinuation rate of about 5% remains well below the 10% yearly average typical for wet AMD trials. Importantly, none of these discontinuations were related to treatment. At this stage, all patients across the LUGANO and LUCIA trials have reached the week-32 visit, during which patients in the DURAVYU arms received their second DURAVU dose. Over 35% of those patients have since received their third planned dose of DURAVU at week 56. As a reminder, we received 2 consecutive positive recommendations from the independent Data Safety Monitoring Committee with a third review scheduled for later this month. We are optimistic that the interim masked safety data will continue to remain consistent, further strengthening DURAVYU's clinical profile. In addition, we believe the multi-mechanism of action or MOA of DURAVYU's active ingredient, vorolanib, will prove to be a key clinical differentiator. Along with blocking all VEGF isoforms and PDGF at the receptor level, preclinical data supports vorolanib's ability to inhibit IL-6 signaling via the JAK1 receptor. With this unique ability to not only address both the vascular leakage and inflammation that contributes to retinal disease pathogenesis, but also potentially provide sustained release efficacy, DURAVYU is uniquely designed to deliver wide-reaching therapeutic potential. Earlier this week, we presented peer-reviewed data at the Association for Research in Vision and Ophthalmology, or ARVO meeting that reinforces these findings and further substantiate DURAVYU's potential to improve long-term outcomes for patients. A primary kinase screen and subsequent measure of IC50 levels identified vorolanib as a potent inhibitor of JAK1, which plays a critical role in IL-6 mediated inflammation. In addition, vorolanib proved to be a potent inhibitor of IL-6 leakage in an in vitro cellular model. This data further highlights the multi-MOA potential of DURAVYU with the opportunity to bring a synergistic anti-inflammatory effect in addition to established VEGF and PDGF inhibition to the treatment of wet AMD and DME. As we near top line data for our Phase III wet AMD program, it's worth remembering the key elements underpinning its thoughtful design. Our approach is derisked, following an established non-inferiority regulatory pathway. Both pivotal trials are identical and compared DURAVYU to on-label 2-milligram aflibercept, which is intended to reflect real-world practice and generate clinically-relevant data to inform the retina community. Additionally, both trials are evaluating 6-month redosing and statistical superiority in treatment burden reduction to support the potential for a compelling label that addresses the need for effective, durable disease control. Taken together, we believe our Phase III program is well positioned to deliver data that will build upon our positive clinical development track record and contribute to strong commercial positioning for DURAVYU, if approved. We look forward to reporting top line data from our Phase III wet AMD trial, LUGANO, this summer with our second trial, LUCIA to follow shortly thereafter. We are applying the same derisked approach to our Phase III DME program, which leverages a non-inferiority design, an on-label 2-milligram aflibercept control, and redosing every 6 months. Similar to our wet AMD program, we designed our pivotal trials for DME based on impressive data from the Phase II VERONA study in which DURAVYU demonstrated rapid efficacy with 4 to 5 letters of vision improvement and approximately 50-micron improvement in anatomic control compared to aflibercept at week 4. Both of our DME trials, COMO and CAPRI are now underway with over 1/3 of patients enrolled across both trials following first patient dosing at the end of February of this year. Our strong pace of enrollment is driven by our ability to leverage our pre-existing clinical trial infrastructure and investigator network as well as the significantly smaller trial size compared to our wet AMD program. We expect top line data in the second half of 2027. Stepping back, both wet AMD and DME together represent the vast majority of the global branded retinal disease treatment market with a combined branded opportunity totaling nearly $15 billion in the U.S. and growing. Through exceptional clinical leadership and commitment to serving the retinal community, we are positioning DURAVYU to become a durable franchise with blockbuster potential. With a unique multi-MOA, robust clinical data package, proven delivery technology, the ability to be shipped and stored at ambient temperatures and administration via standard in-office intravitreal injection, DURAVYU represents a compelling and truly innovative product profile that has the potential to reshape the treatment paradigm for serious retinal diseases. We continue to make significant strides in our commercial readiness while remaining disciplined in our investments as we prepare for regulatory submission. We have thoughtfully grown our organization with the addition of Michael Campbell as Chief Commercial Officer last quarter. In addition to expansion across key areas such as marketing and market access, regulatory, compliance and medical affairs to build on our organizational capabilities as we advance our launch planning and strategy for DURAVYU in wet AMD. In addition to progress on our commercial readiness activities, we continue to prioritize CMC readiness. Our cGMP facility in Northbridge, Massachusetts has been online for over a year, supporting our plans for an anticipated CMC submission for our potential new drug application or NDA as well as for commercial supply, if approved. We continue to prepare for pre-approval inspection, underscoring our growing independent commercial readiness that we believe will ensure our preparedness to deliver DURAVYU to patients upon potential approval. Before passing it over to George to review the financials, I'd like to thank the entire EyePoint team for your unwavering commitment to improving the quality of retinal care. We are proud to support the retina community and grateful to the patients, study coordinators and clinical investigators who enable our research. We look forward to our upcoming Phase III wet AMD readouts together with continued progress in our DME program, which we believe sets the stage for meaningful value creation at EyePoint. I will now turn the call over to George. George Elston: Thank you, Jay. As the financial results for the 3 months ended March 31, 2026, were included in the press release issued this morning, my comments today will be focused on a high-level review for the quarter. Importantly, we continued our disciplined financial management and good stewardship of our resources, ending the first quarter with $223 million in cash and investments. For the quarter ended March 31, 2026, total net revenue was $0.7 million compared to $24.5 million for the quarter ended March 31, 2025. The decrease was primarily driven by the recognition of remaining deferred revenue related to the company's agreement in the second quarter of 2023 for the license of YUTIQ product rights. Operating expenses for the quarter ended March 31, 2026, totaled $88 million compared to $73 million in the prior year period. This increase was primarily driven by the ongoing Phase III trials for DURAVYU in both wet AMD and DME and the scaleup of our Northbridge commercial manufacturing facility. Net non-operating income totaled $2 million and net loss was $85 million or $0.99 per share compared to a net loss of $45 million or $0.65 per share for the prior year period. As I noted earlier, cash, cash equivalents and investments in marketable securities on March 31, 2026, totaled $223 million compared to $306 million as of December 31, 2025. We continue to expect that our current cash position will enable us to fund operations into the fourth quarter of 2027 beyond key milestones for the Phase III wet AMD program expected later this year. In conclusion, we're pleased with EyePoint's progress so far in 2026 and remain well capitalized to deliver DURAVYU through key value-driving milestones in the 2 largest retinal disease markets. I will now turn the call back over to Jay for closing remarks. Jay Duker: Thank you, George. As we continue to deliver on our key priorities for 2026, our team is focused on advancing preparations for the pivotal Phase III top line data readout in wet AMD expected mid-year and completing enrollment of our Phase III DME program in the third quarter of this year. We believe TKIs represent the next frontier in retinal disease innovation, and we are proud to be advancing DURAVYU as a potential first and best-in-class option in the 2 largest retinal disease markets. Thank you all for your attention this morning. I will now turn the call back over to the operator for questions. Operator: [Operator Instructions] Our first question comes from the line of Tess Romero with JPMorgan. Tessa Romero: So just one from us, on the DME side, actually. So for your COMO and CAPRI trials, you talked a bit about your swift pace of enrollment here. Can you speak to what you're hearing from the investigators in terms of the level of interest from both patients and physicians around a TKI sustained delivery treatment option like DURAVYU? What are the key differences and similarities that you hear in the DME space versus maybe what you heard in the wet AMD space? Jay Duker: Thanks for the question, Tess. Given that our CMO, Ramiro Ribeiro, is really at the forefront of this, I'll ask him to answer your question. Ramiro Ribeiro: Tess, thanks for the question. So first, as you mentioned, we are seeing a great excitement around our DME program, COMO and CAPRI with a quite quick enrollment so far. We are now leveraging all the infrastructure that we use for our wet AMD with our clinical sites and our CRO and vendor as well. The feedback that we're getting from the investigators, very similar to our wet AMD, is that our study is a very patient-centric study, trying to address a very important unmet need, which is the treatment burden. So patients that are participating in this study are very excited for a therapy that can last for about 6 months. In particular, for the DME indication, we know that the need for this patient population might be even greater than wet AMD. This is a patient population that is relatively younger, and they are still in the workplace. So a therapy that can reduce the number of visits like DURAVYU is, of course, of very interest for this patient population. Again, I think the excitement both from the investigators, the patient in clinical sites is being reflected in the pace of our enrollment. Jay Duker: And I'd like to add just one more thought to this. We invited 90 of our wet AMD investigators to be investigators in the DME trials and all 90 accepted. So we believe that continues to show investigators' enthusiasm for the potential of DURAVYU. Operator: Our next question comes from the line of Yigal Nochomovitz with Citigroup. Yigal Nochomovitz: I'm just wondering if you could comment on how the supplement trigger criteria are functioning in the Phase III trial relative to the Phase II trial, the DAVIO 2 trial? And if you could also comment on what you would expect to be a meaningful supplement rate in the Phase III trial that would be consistent with a strong commercial uptake. Jay Duker: Yigal, nice to hear from you. Thanks for the question. With respect to supplements, I'm going to have Ramiro comment in a moment about how that is working in the trial. But I think there's really 2 issues around the supplementation that people should understand. The first is that in the clinical trials, supplements will be handled statistically with sensitivity analyses that we will be doing when we submit the NDA. So there is a rate of supplements, at least conceivably, above which the drug would not be considered to be working independently because of the high rate of supplements. In saying that, the FDA has never put a line in the sand as to what that level would be, because they want to see the totality of the data. They want to see the safety and the efficacy otherwise. So, from a supplementation perspective, there is an important hurdle, which, of course, we need to get over, which is the non-inferior margin, which is the primary endpoint. If we are approved, then I think the commercial acceptance shifts to a very different place. In the real world, a supplement is not a failure. Doctors, I believe, if we are approved, will enjoy taking advantage of using 2 MOAs to help a [indiscernible] across a lot of chronic diseases, where if 2 MOAs in treatment are available, using them synergistically is a potential advantage to patients. Now obviously, we haven't shown that yet in our trials, but we hope that, that would be the case for the benefit of patients. But my point about supplements in the real world, I'll give you again an example. If I've got a patient that I have to inject every 2 months with a biologic anti-VEGF and let's hypothesize that DURAVYU is FDA approved, it's safe, it's tolerable. It has a label for every 6 months and the patient gets shifted to DURAVYU, for the next year with 2 injections. But in addition, they received 2 injections of a biologic. Well, it's a great win for everyone. The patient can go from every 2 months to every 3 months from 6 injections to 4 injections and that presumably the advantages of DURAVYU will be aligned with the patient and the doctor's interest. So there is the regulatory hurdle that needs to be reached over supplements. And if that's reached, I believe that supplementation in the real world will have great latitude for acceptance. Yigal Nochomovitz: Okay. And then if I could just ask one other follow-up on DME. Of course, you mentioned IL-6 as a potentially interesting biomarker. Are any of those IL-6 biomarker endpoints formally embedded in the Phase III DME program as sort of secondary endpoints that could help differentiate the product? Jay Duker: I would say yes, but indirectly. Given that there is no way to measure in a patient in a clinical trial, the direct effects on IL-6 or JAK1, we would be measuring the indirect effects. The indirect effects, of course, number one is visual acuity. What we hope to be doing in the long term is provide better visual acuity for patients. But in DME, we may be able to provide it in the short term. Again, looking at the VERONA data at week 4, the patients who received DURAVYU had better vision and drier retinas as early as week 4 compared to a single dose of aflibercept. We have set up the COMO and CAPRI trials to try to show that. And there is a secondary endpoint of visual acuity and OCT at week 4, given our drug is given at day 1 in the DME trials so that -- we hope to show that even if we're non-inferior and equivalent to Eylea, but we can provide the benefit earlier with fewer injections, then we will be able to have a great advantage to patients and therefore, a commercial success. There are other secondary endpoints that we can look at that are not direct measurements of IL-6 or JAK inhibition. For example, leakage on fluorescein angiography. And you may recall that in the VERONA trial, we had a significant reduction in leakage as measured by an independent reading center, and it was dose-dependent, with the higher dose of 2.7 milligrams showing much greater leakage reduction compared to the lower dose and compared to the aflibercept control. And that is the kind of secondary endpoint that if we can show reduction in leakage greater than aflibercept, I think the evidence would lead to that is due to IL-6 inhibition. Operator: Our next question comes from the line of Faisal Khurshid with Jefferies. Faisal Khurshid: I just wanted to ask on the ongoing wet AMD studies, are you guys able to see blinded rescue rates? And are those tracking in line with your expectations? Jay Duker: Thanks for the question, Faisal. Again, I'll let Ramiro talk about the supplementations and what we're seeing and what we're not seeing. Ramiro Ribeiro: Faisal, thanks for the question. We -- there's a very small team at EyePoint that reviews the supplementation injections essentially to make sure that the clinical sites are following the protocol. But we don't review aggregated supplemental injection rate, and that's something that we don't disclose publicly. Jay Duker: And if I may add, we -- again, as Ramiro indicated, have no insight into the number of supplements, supplementation rate, et cetera, at this point. It's all masked. But we do anticipate that the supplementation rates in the Phase III trials will be less than what we saw in the Phase II for several reasons, again, due to the tightening of the supplement criteria, getting rid of the physician discretion in supplements, the reinjection at month 6 and the inclusion of the majority of naive patients, all of those together should result in fewer supplements in Phase III. Operator: Our next question comes from the line of Yatin Suneja with Guggenheim. Eddie Hickman: I'm sorry. This is Eddie on for Yatin. Thinking about the fixed-dose regimen that you guys are going after, are patients who are already dry with stable vision still receiving that third dose at week 56? And if so, is there any incremental safety signal from redosing well-controlled patients? And further, has the FDA weighed in on how this complicates the retreatment redosing schedule? Jay Duker: Thanks, Eddie. Very good question. And yes, this is a fixed dose regimen. It has nothing to do with whether the patient at the time of their repeat dose of DURAVYU is dry or wet or what the visual acuities are. So just like any drug, for example, take 2-milligram Eylea, when it was first studied every 2 months, that was fixed dose where they received that injection, whether they were active or not. So that's going to be true in our trial. From the perspective of safety, we've done extensive preclinical safety in animals. And in rabbits, we never found a maximally tolerated dose of vorolanib, and we've injected scale dose of about 10x higher than anything we could achieve in humans. We've also not found the maximally tolerated number of inserts in rabbits. And so from a safety perspective, we were not concerned about reinjection. Again, we are reviewing the masked safety. And I will once again turn to Ramiro if he wants to comment on the upcoming DMC meeting that is going to be occurring shortly. Ramiro Ribeiro: Yes. No, thanks, and thanks, Eddie, for the question. We -- as Jay mentioned, safety is something that is, of course, paramount for EyePoint, and we conduct ongoing safety review of the data. If you do the math, we have now have patients that reached that week 56 visit that you mentioned, which is the third dose of EYP-1901, and we haven't seen anything different than what we saw before. We do have an upcoming DMC meeting in the month of May, where the members will review our masked data, and we look forward to provide updates after that meeting. Operator: Our next question comes from the line of Debanjana Chatterjee with Jones. Debanjana Chatterjee: So what have you seen in the masked safety data set so far? And has anything shifted your expectations going into the DSMB review that is scheduled for late May? Jay Duker: Thanks for the question, Debanjana. And we're not commenting on any individual SAEs or AEs. But in total, I would say and repeat what Ramiro has said, what we've seen so far is consistent with what we have seen in the prior 4 trials. No new safety concerns and no incidents that we haven't seen or expected from before. Again, Ramiro, I don't know if you want to add any more color to what I said. Ramiro Ribeiro: Yes. No, I think just again, to reiterate, safety at EyePoint is paramount. We -- internally, we review the data on an ongoing basis on a masked fashion. And as Jay mentioned, we have no safety signal. We haven't attacked anything that is new. The safety profile continues to be very similar to what we saw in our previous completed studies. Debanjana Chatterjee: Just a very quick follow-up. Can we expect any formal public update following the DSMB meeting? Jay Duker: Yes. I think it's likely that we will give an update, yes. Operator: Our next question comes from the line of Lisa Walter with RBC Capital Markets. Lisa Walter: Congrats on the progress. We have seen a long-acting TKI competitor had a successful readout of their pivotal study earlier this year. And we've heard their plan is to file with the FDA and seek approval on this trial alone. In a scenario where essentially both, yours and the other long-acting TKI, are being launched within similar time frames, does perhaps having 2 products with the same mechanism of action actually help break into a market which already has an established therapeutic base with the anti-VEGF? How should we think about this? Jay Duker: Yes, Lisa, thanks for the question. It's a great question. And I think you've really hit on a very important point. This is not a zero-sum game. The TKIs are going into a multibillion-dollar market. And there is certainly room for 2 competitors to both be very successful in this very large market. There is evidence from -- as I think you're alluding to, from other launches with new mechanism of action into an established space that having more than one entry really helps both because doctors are hearing it and learning about it from multiple places. So we welcome another competitor. And part of that is we believe we've got a better drug and a better delivery system. And hopefully, if both are FDA approved, well we will have the opportunity from a commercial basis to really show that. Operator: Our next question comes from the line of Nick for Colleen Kusy with Baird. Nick Quartapella: It's Nick on for Colleen. So just at ARVO and other recent scientific conferences, just wanted to ask what -- just what the takeaways were on DURAVYU, sentiment among physicians and if you got any learnings about how physicians intend on using DURAVYU upon a potential approval? Jay Duker: So one point I'd like to make, and thanks for the question, Nick. One point I'd like to make about ARVO is we had a poster there, which showed another preclinical model of leakage induced by VEGF and IL-6. And in that model, vorolanib, the active ingredient in EYP-1901 was able to suppress the inflammation induced by IL-6 and VEGF equal to an anti-VEGF and an anti-IL-6. So again, one more model that suggests that vorolanib does have potent anti-IL-6 activity through the JAK1 receptor. There was a lot of interest in that poster. A lot of KOLs saw it, and there were quite a number of comments. Ramiro met with multiple KOLs at ARVO, and I will let him weigh in on what the sentiment seems to be around EYP-1901. Ramiro Ribeiro: Yes. No, thanks, Nick, for the question. And we had a very productive ARVO this year with several posters being presented, including the one that Jay just mentioned. We also had a few advisory boards and some interactions with our Phase III wet AMD and DME investigators. I think first on the sentiment of the clinical trials, I think everybody, of course, is very excited for the upcoming data for LUGANO and LUCIA. Mentions are, this is going to be the highlight of the retina space for the year of 2026. For DME, the investigators, again, reflect that this is a really well-studied plan, very patient-centric, and they were all excited about bringing the therapy for patients with DME. In terms of future use of DURAVYU, as Jay mentioned previously in the call, they expressed the important unmet need that we're trying to address with DURAVYU. And they see this if we can replicate the results that we saw in the Phase II study as something that is going to be very meaningful for patients, especially for those patients that require frequent treatment. Operator: Our next question will be coming from the line of Yale Jen with Laidlaw. Yale Jen: And I just follow up a little bit on the commercial question earlier, which is that besides the TKIs, in terms of the long-acting biologics, VABYSMO and the high-dose Eylea, which one you think you [ scale really ], if approved, will be competing more or less? And any comment on that? Jay Duker: Thanks for the question, Yale. It's an important question because these are excellent medications that are multibillion-dollar drugs that are really helping many, many patients. I think the first point to be clear on is we're not another anti-VEGF biologic. We work at the receptor level. We have multi-MOA block VEGF, PDGF, and we do believe the inflammation related to IL-6 elevation, which is not something that they do. In addition, it looks like from our Phase II data that at least 2/3 of the wet AMD population could be treated with our drug alone every 6 months should physicians choose to do that. That's not something that we're seeing in the real world with those new medications. While there are extended durations, what the real-world data is suggesting that most patients are getting about a week or 2 extension from either of those drugs compared to what they were on before. Now that's great, but we still believe that it leaves a lot of room in the market for a 6-month or longer medication. I -- it's hard to predict which of those drugs will be -- I don't want to say the winner because I think both drugs are doing well when we launch potentially. But we -- again, our belief is that we can provide benefits greater than what either of those drugs can do for patients. And we believe in the long term, we will achieve better visual acuity. Mike Campbell, our Chief Commercial Officer, I believe, is on the line. And I don't know if he's going to maybe have any other comments now. I think it's a little early to talk about commercial strategy. But maybe, Mike, you can talk a little bit about how you view the competition. Michael Campbell: Yes. Thank you for the question. The one point I would add is that while we have these very good anti-VEGFs, longer-acting anti-VEGFs in the market, not only is the real-world data showing the extension that Jay mentioned around 8 days. We also look at what the retina specialists are saying in the community and where the needs are. And so if you look at the American Society of Retina Specialists, ASRS, every year, they put out a PAT survey. And very consistently, the #1 need in wet AMD treatments that is reported from ASRS is still durability even with VABYSMO and Eylea HD in the market. So to Jay's point, there is a very clear opportunity should DURAVYU be successful and be approved, there's a very clear opportunity or room in this market for more durable agents. Operator: Our next question comes from the line of Samuel Rollenhagen with TD Cowen. Samuel Rollenhagen: This is Sam on for Tara. Can you hear me? Jay Duker: Yes. Samuel Rollenhagen: Congrats on another great enrollment update. So I just wanted to ask on safety for the LUGANO data. And if you could help us set some expectations there for what you're hoping to see. I guess, besides avoiding some of the more serious back of the eye events, are there any other AEs where you think DURAVYU could be differentiated versus competitors? And then also, it'd just be great if you could clarify how you're anticipating to disclose those safety data in the top line release? Will you be reporting all events or just those above a specific threshold? Jay Duker: Thanks for the question, Sam. And so again, the -- one of the hallmarks of the current anti-VEGF approved drugs with perhaps one exception, is they're quite safe. And while patients and physicians will probably be willing to accept perhaps a few more AEs from a long-acting drug, there can't be a big difference. There's really a high bar that's out there for safety. And the good news is that all our safety from our 4 reported trials shows no real increase in any SAE or AE that would preclude our drug from being widely accepted, in our opinion. So from a safety perspective, again, a lot of the safety issues that can occur are injection related. And if you're reducing the number of injections that a patient gets, then you're likely in the long term to have fewer adverse events. We hope to be able to show that in our pivotal trials. And from a reporting perspective, I don't know how granular the safety reporting will be initially, but we do expect to have complete AE tables when we present the data from LUGANO and LUCIA. Operator: I'm showing no further questions in the queue at this time. Ladies and gentlemen, thank you for participating in today's conference. This does conclude your program, and you may now disconnect. Everyone, have a great day. Before you buy stock in EyePoint, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and EyePoint wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. EyePoint (EYPT) Q1 2026 Earnings Transcript was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-05-07

EyePoint Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary

Moby
Management attributes the program's momentum to a 'derisked' clinical strategy that utilizes established non-inferiority regulatory pathways and on-label aflibercept controls to reflect real-world practice. The DURAVYU value proposition is centered on a multi-mechanism of action (MOA) that inhibits VEGF, PDGF, and IL-6 via the JAK1 receptor, potentially addressing both vascular leakage and inflammation. Operational execution is highlighted by a low 5% discontinuation rate in Phase III trials, which management notes is significantly below the 10% yearly average typical for wet AMD studies. Strategic positioning focuses on the 'treatment burden' unmet need, particularly in the DME market where a younger, working-age patient population may prioritize fewer clinic visits. The company is transitioning toward a fully integrated biopharmaceutical model, supported by an internal cGMP manufacturing facility in Northbridge to ensure commercial supply readiness. Management views the TKI landscape as a non-zero-sum game, suggesting that multiple competitors will help validate the mechanism and shift the established anti-VEGF therapeutic base. Topline Phase III data for the LUGANO wet AMD trial is expected in mid-2026, with the LUCIA trial results to follow shortly thereafter. Full enrollment for the Phase III DME program (COMO and CAPRI trials) is targeted for the third quarter of 2026, with topline data anticipated in the second half of 2027. Financial guidance assumes the current cash position of $223 million is sufficient to fund operations into the fourth quarter of 2027, covering key Phase III milestones. Commercial readiness activities are scaling up, including planned CMC submissions for the New Drug Application (NDA) and preparations for pre-approval inspections. Management expects Phase III supplementation rates to be lower than Phase II due to tighter criteria, the removal of physician discretion, and the inclusion of treatment-naive patients. The significant year-over-year revenue decrease ($0.7M vs $24.5M) was primarily due to the prior year's recognition of deferred revenue from the YUTIQ product rights license. Operating expenses increased to $88 million, driven by the simultaneous execution of Phase III trials in two indications and the scale-up of commercial manufacturing capabilities. A third independent Data Safety Monitoring Committee review is schedu…Read full document

Management attributes the program's momentum to a 'derisked' clinical strategy that utilizes established non-inferiority regulatory pathways and on-label aflibercept controls to reflect real-world practice. The DURAVYU value proposition is centered on a multi-mechanism of action (MOA) that inhibits VEGF, PDGF, and IL-6 via the JAK1 receptor, potentially addressing both vascular leakage and inflammation. Operational execution is highlighted by a low 5% discontinuation rate in Phase III trials, which management notes is significantly below the 10% yearly average typical for wet AMD studies. Strategic positioning focuses on the 'treatment burden' unmet need, particularly in the DME market where a younger, working-age patient population may prioritize fewer clinic visits. The company is transitioning toward a fully integrated biopharmaceutical model, supported by an internal cGMP manufacturing facility in Northbridge to ensure commercial supply readiness. Management views the TKI landscape as a non-zero-sum game, suggesting that multiple competitors will help validate the mechanism and shift the established anti-VEGF therapeutic base. Topline Phase III data for the LUGANO wet AMD trial is expected in mid-2026, with the LUCIA trial results to follow shortly thereafter. Full enrollment for the Phase III DME program (COMO and CAPRI trials) is targeted for the third quarter of 2026, with topline data anticipated in the second half of 2027. Financial guidance assumes the current cash position of $223 million is sufficient to fund operations into the fourth quarter of 2027, covering key Phase III milestones. Commercial readiness activities are scaling up, including planned CMC submissions for the New Drug Application (NDA) and preparations for pre-approval inspections. Management expects Phase III supplementation rates to be lower than Phase II due to tighter criteria, the removal of physician discretion, and the inclusion of treatment-naive patients. The significant year-over-year revenue decrease ($0.7M vs $24.5M) was primarily due to the prior year's recognition of deferred revenue from the YUTIQ product rights license. Operating expenses increased to $88 million, driven by the simultaneous execution of Phase III trials in two indications and the scale-up of commercial manufacturing capabilities. A third independent Data Safety Monitoring Committee review is scheduled for late May 2026 to evaluate ongoing masked safety data. The company maintains a disciplined investment approach while expanding key organizational functions in marketing, regulatory, and medical affairs ahead of potential launch. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management clarified that while high supplementation could impact non-inferiority statistical hurdles, the FDA looks at the 'totality of data' rather than a specific percentage cutoff. In a commercial setting, management argues that supplementation is not a failure but a synergistic use of two MOAs that still reduces overall treatment burden for the patient. EyePoint contends that real-world data for new biologics shows only modest duration extensions (approximately 8 days), leaving a significant market gap for 6-month sustained release. DURAVYU's ability to inhibit IL-6 mediated inflammation is cited as a key differentiator that biologics do not currently address. Management reported that over 35% of Phase III patients have already received their third planned dose at week 56 with no new safety signals observed in masked data. Preclinical rabbit models supported safety at doses 10x higher than human levels, providing confidence in the fixed-dose 6-month redosing schedule. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Investor releaseQuarter not tagged2026-05-06

Eyepoint Pharmaceuticals Q1 Earnings Call Highlights

MarketBeat
EyePoint expects phase III wet AMD top-line data beginning mid-year (LUGANO “this summer” with LUCIA to follow), pursuing a non-inferiority pathway versus on‑label 2 mg aflibercept while targeting six‑month redosing and durability; the trials have had two positive DSMC reviews and a low ~5% discontinuation rate. The phase III DME program (COMO and CAPRI) is rapidly enrolling with >1/3 of patients enrolled and full enrollment targeted in Q3 2026, with top-line data expected in H2 2027, and the company highlights vorolanib’s multi‑mechanism profile (VEGF, PDGF, and JAK1/IL‑6 signaling) as a potential differentiator for reduced treatment burden. Financially, Eyepoint ended Q1 with $223 million in cash and investments and reported a net loss of $85 million ($0.99/share) as operating expenses rose to $88 million, and management says current cash should fund operations into Q4 2027, past the wet AMD milestones. Interested in Eyepoint Pharmaceuticals, Inc.? Here are five stocks we like better. Breakout Momentum Plays You May Not Know About EyePoint Pharmaceuticals (NASDAQ:EYPT) executives told investors the company is approaching what they described as a “pivotal inflection point” for its lead program, DURAVYU, with phase III wet age-related macular degeneration (wet AMD) top-line data expected beginning mid-year and a rapidly enrolling phase III program in diabetic macular edema (DME). President and CEO Dr. Jay Duker said the company remains on track to report phase III top-line data from its wet AMD program, with results from the LUGANO trial expected “this summer” and the second trial, LUCIA, “to follow shortly thereafter.” Duker said EyePoint believes it could “potentially be the first to market among all current investigational sustained release programs.” → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries Duker reiterated that EyePoint’s phase III wet AMD program is built on a non-inferiority regulatory pathway and compares DURAVYU to on-label 2 mg aflibercept. He said both pivotal trials also evaluate six-month redosing and “statistical superiority in treatment burden reduction” aimed at supporting a label focused on durability. On trial progress and safety monitoring, Duker said all patients in LUGANO and LUCIA have reached the week 32 visit, when patients in the DURAVYU arms received a second dose. He added that more than 35% of pat…Read full document

EyePoint expects phase III wet AMD top-line data beginning mid-year (LUGANO “this summer” with LUCIA to follow), pursuing a non-inferiority pathway versus on‑label 2 mg aflibercept while targeting six‑month redosing and durability; the trials have had two positive DSMC reviews and a low ~5% discontinuation rate. The phase III DME program (COMO and CAPRI) is rapidly enrolling with >1/3 of patients enrolled and full enrollment targeted in Q3 2026, with top-line data expected in H2 2027, and the company highlights vorolanib’s multi‑mechanism profile (VEGF, PDGF, and JAK1/IL‑6 signaling) as a potential differentiator for reduced treatment burden. Financially, Eyepoint ended Q1 with $223 million in cash and investments and reported a net loss of $85 million ($0.99/share) as operating expenses rose to $88 million, and management says current cash should fund operations into Q4 2027, past the wet AMD milestones. Interested in Eyepoint Pharmaceuticals, Inc.? Here are five stocks we like better. Breakout Momentum Plays You May Not Know About EyePoint Pharmaceuticals (NASDAQ:EYPT) executives told investors the company is approaching what they described as a “pivotal inflection point” for its lead program, DURAVYU, with phase III wet age-related macular degeneration (wet AMD) top-line data expected beginning mid-year and a rapidly enrolling phase III program in diabetic macular edema (DME). President and CEO Dr. Jay Duker said the company remains on track to report phase III top-line data from its wet AMD program, with results from the LUGANO trial expected “this summer” and the second trial, LUCIA, “to follow shortly thereafter.” Duker said EyePoint believes it could “potentially be the first to market among all current investigational sustained release programs.” → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries Duker reiterated that EyePoint’s phase III wet AMD program is built on a non-inferiority regulatory pathway and compares DURAVYU to on-label 2 mg aflibercept. He said both pivotal trials also evaluate six-month redosing and “statistical superiority in treatment burden reduction” aimed at supporting a label focused on durability. On trial progress and safety monitoring, Duker said all patients in LUGANO and LUCIA have reached the week 32 visit, when patients in the DURAVYU arms received a second dose. He added that more than 35% of patients have received their third planned dose at week 56. The company has received “two consecutive positive recommendations” from the Independent Data and Safety Monitoring Committee, with a third review scheduled for later in the month. → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches Duker also pointed to a low discontinuation rate in the wet AMD phase III program. “Our low discontinuation rate of about 5% remains well below the 10% yearly average typical for wet AMD trials,” he said, adding that none of the discontinuations were related to treatment. Duker emphasized the company’s view that DURAVYU’s active ingredient, vorolanib, could be differentiated by a multi-mechanism approach. In prepared remarks, he said vorolanib blocks all VEGF isoforms and PDGF at the receptor level, and that preclinical data supports an ability to inhibit IL-6 signaling via the JAK1 receptor. → Tyson Foods' Total Returns: Tasty Treats for Income Investors? EyePoint also discussed data it presented at the Association for Research in Vision and Ophthalmology (ARVO) meeting. Duker said a primary kinase screen and IC50 testing identified vorolanib as “a potent inhibitor of JAK1,” and said the compound inhibited IL-6 leakage in an in vitro model. Later in the call, he described an additional preclinical model involving leakage induced by VEGF and IL-6, saying vorolanib suppressed inflammation in a manner comparable to “an anti-VEGF and an anti-IL-6.” EyePoint said its phase III DME program is advancing quickly. Duker said enrollment is “rapidly progressing” and the company is targeting full enrollment in both pivotal DME trials in the third quarter of 2026. He noted both DME studies (COMO and CAPRI) are underway, with “over one-third of patients enrolled across both trials” following first patient dosing at the end of February. Top-line data is expected in the second half of 2027. Chief Medical Officer Dr. Ramiro Ribeiro attributed the pace in part to reusing infrastructure from the wet AMD program, including clinical sites and vendors. He said investigators have described the DME trials as “very patient-centric” and focused on reducing treatment burden, adding that patients are “very excited for a therapy that can last for about six months.” Ribeiro also said the need may be even greater in DME because patients tend to be younger and working, making fewer visits particularly valuable. Duker added that EyePoint invited 90 wet AMD investigators to participate in the DME trials, and “all 90 accepted,” which he said reflects enthusiasm for DURAVYU. Discussing endpoints, Duker said EyePoint cannot directly measure IL-6 or JAK1 effects in patients, but is assessing indirect effects. He highlighted secondary endpoints in COMO and CAPRI including visual acuity and OCT at week four, reflecting observations the company cited from its phase II VERONA study. Duker also mentioned fluorescein angiography leakage as another secondary measure, noting that in VERONA, leakage reduction was significant and dose-dependent, and he suggested that greater leakage reduction versus aflibercept would support an inflammation-related mechanism. Several analysts asked about rescue or supplementation injections. Duker said supplementation in the wet AMD phase III trials will be handled statistically with sensitivity analyses as part of a potential NDA submission and emphasized that the FDA considers the “totality of the data.” Ribeiro said EyePoint does not review aggregated supplementation injection rates and does not disclose that data publicly. Responding to a question about whether the company can see blinded rescue rates, Ribeiro said only a small internal team reviews supplementation injections to ensure sites follow protocol. Duker added that EyePoint expects supplementation rates in phase III to be lower than in phase II, citing “tightening of the supplement criteria,” removing physician discretion, redosing at six months, and enrolling a majority of treatment-naïve patients. Duker said EyePoint continues to invest in launch readiness while remaining “disciplined” with spending. He noted the addition of Chief Commercial Officer Mike Campbell and said the company has expanded capabilities in areas including marketing, market access, regulatory, compliance, and medical affairs. He also discussed manufacturing readiness, saying EyePoint’s cGMP facility in Northbridge, Massachusetts, has been online for more than a year and is intended to support an anticipated CMC submission for a potential NDA and commercial supply if approved. Duker said the company is preparing for a pre-approval inspection. On competition, Duker responded to questions about other long-acting TKIs and longer-acting anti-VEGF biologics. He said there is “room for two competitors” in a large market and argued that multiple entries with a new mechanism can help drive physician awareness. On existing long-acting anti-VEGFs, Campbell cited American Society of Retina Specialists survey results, saying the “number one need” in wet AMD treatment remains durability. Executive Vice President and CFO George Elston said EyePoint ended the first quarter with $223 million in cash and investments. Total net revenue was $0.7 million for the three months ended March 31, 2026, compared with $24.5 million in the prior-year period. Elston said the decrease was primarily due to the recognition of remaining deferred revenue related to a second-quarter 2023 agreement for the license of YUTIQ product rights. Operating expenses rose to $88 million from $73 million a year earlier, which Elston attributed primarily to phase III trials for DURAVYU in wet AMD and DME and the scale-up of the Northbridge manufacturing facility. Net non-operating income was $2 million. Net loss was $85 million, or $0.99 per share, compared with a net loss of $45 million, or $0.65 per share, in the prior-year quarter. Elston said cash, cash equivalents, and investments in marketable securities totaled $223 million as of March 31, 2026, down from $306 million at Dec. 31, 2025. He said the company expects its current cash position to fund operations into the fourth quarter of 2027, “beyond key milestones for the phase III wet AMD program expected later this year.” In closing remarks, Duker said the company remains focused on preparing for the wet AMD phase III top-line data readout expected mid-year and completing enrollment in the phase III DME program in the third quarter of 2026. Eyepoint Pharmaceuticals, Inc is a biopharmaceutical company focused on the development and commercialization of therapies for the treatment of ocular diseases. The company's proprietary platform centers on sustained-release formulations designed to improve drug delivery to the posterior segment of the eye, addressing conditions that often require repeated intravitreal injections or intensive topical regimens. Eyepoint's commercial strategy combines in-house sales and marketing capabilities with targeted partnerships to bring its therapies to ophthalmologists and retina specialists across the United States. Eyepoint's lead products include YUTIQ, a fluocinolone acetonide intravitreal implant indicated for the prevention of relapse in non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU, a dexamethasone intraocular suspension approved for postoperative inflammation following ocular surgery. The article "Eyepoint Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat.

Investor releaseQuarter not tagged2026-05-06

EyePoint: Q1 Earnings Snapshot

Associated Press

WATERTOWN, Mass. (AP) — WATERTOWN, Mass. (AP) — EyePoint, Inc. (EYPT) on Wednesday reported a loss of $84.8 million in its first quarter. On a per-share basis, the Watertown, Massachusetts-based company said it had a loss of 99 cents. The results missed Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 79 cents per share. The drug delivery technology company posted revenue of $696,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on EYPT at https://www.zacks.com/ap/EYPT

Investor releaseQuarter not tagged2026-05-06

EyePoint Reports First Quarter 2026 Financial Results and Highlights Recent Corporate Developments

GlobeNewswire
Phase 3 wet AMD trials, LUGANO and LUCIA, remain on track with topline data expected beginning mid-2026 – Phase 3 DME clinical trials, COMO and CAPRI, rapidly advancing with over one-third of patients enrolled; enrollment completion expected in Q3 2026 – $223 million of cash and investments as of March 31, 2026, with runway into Q4 2027 – WATERTOWN, Mass., May 06, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the first quarter ended March 31, 2026, and highlighted recent corporate developments. “We are entering an important time for EyePoint and the retina community with Phase 3 topline data for DURAVYU in wet AMD expected beginning mid-year with LUGANO topline data and the identical LUCIA trial data readout to follow,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “In parallel, enrollment in our Phase 3 DME program is meeting our ambitious timelines with full enrollment expected in the third quarter of 2026, positioning DURAVYU for pivotal readouts in the two largest multi-billion-dollar retina markets.” Dr. Duker continued, “DURAVYU is well positioned to potentially bring a new multi-mechanism of action sustained delivery treatment option to patients and physicians in these important retinal disease markets. DURAVYU’s robust clinical profile to date, combined with our de-risked and patient-centric approach, drives our conviction for its best- and first-in-class potential.” R&D Highlights and Updates DURAVYU (vorolanib intravitreal insert) in Wet Age-Related Macular Degeneration (Wet AMD) Phase 3 wet AMD trials on track for data readouts beginning mid-year with LUGANO data and LUCIA data to shortly follow. The identical non-inferiority trials versus an on-label aflibercept control enrolled over 900 patients, include every six-month re-dosing, and follow a clear and recognized regulatory approval pathway. All active patients in the treatment arm have reached the Week 32 visit, during which patients received their second DURAVYU dose. Over 35% of those patients have also received their third planned dose at Week 56. Interim masked Phase 3 safety data remain consistent with the favorable safety observed in the four previously completed DURAVYU…Read full document

Phase 3 wet AMD trials, LUGANO and LUCIA, remain on track with topline data expected beginning mid-2026 – Phase 3 DME clinical trials, COMO and CAPRI, rapidly advancing with over one-third of patients enrolled; enrollment completion expected in Q3 2026 – $223 million of cash and investments as of March 31, 2026, with runway into Q4 2027 – WATERTOWN, Mass., May 06, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the first quarter ended March 31, 2026, and highlighted recent corporate developments. “We are entering an important time for EyePoint and the retina community with Phase 3 topline data for DURAVYU in wet AMD expected beginning mid-year with LUGANO topline data and the identical LUCIA trial data readout to follow,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “In parallel, enrollment in our Phase 3 DME program is meeting our ambitious timelines with full enrollment expected in the third quarter of 2026, positioning DURAVYU for pivotal readouts in the two largest multi-billion-dollar retina markets.” Dr. Duker continued, “DURAVYU is well positioned to potentially bring a new multi-mechanism of action sustained delivery treatment option to patients and physicians in these important retinal disease markets. DURAVYU’s robust clinical profile to date, combined with our de-risked and patient-centric approach, drives our conviction for its best- and first-in-class potential.” R&D Highlights and Updates DURAVYU (vorolanib intravitreal insert) in Wet Age-Related Macular Degeneration (Wet AMD) Phase 3 wet AMD trials on track for data readouts beginning mid-year with LUGANO data and LUCIA data to shortly follow. The identical non-inferiority trials versus an on-label aflibercept control enrolled over 900 patients, include every six-month re-dosing, and follow a clear and recognized regulatory approval pathway. All active patients in the treatment arm have reached the Week 32 visit, during which patients received their second DURAVYU dose. Over 35% of those patients have also received their third planned dose at Week 56. Interim masked Phase 3 safety data remain consistent with the favorable safety observed in the four previously completed DURAVYU clinical trials with no safety signals. DURAVYU (vorolanib intravitreal insert) in Diabetic Macular Edema (DME) Pivotal Phase 3 COMO and CAPRI trials are underway, with over one-third of patients enrolled and activation of ex-US sites now initiated. Full enrollment is expected in the third quarter of 2026, with topline data anticipated in the fourth quarter of 2027. The identical non-inferiority trials versus an on-label aflibercept control are expected to enroll approximately 480 patients, include every six-month re-dosing, and follow a clear and recognized regulatory approval pathway. DURAVYU Highlights Presented new preclinical data at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting that further demonstrates inhibition of pro-inflammatory IL-6 signaling by vorolanib, the active drug in DURAVYU. Vorolanib was identified as a potent inhibitor of JAK1, a critical transducer of IL-6 signaling, through extensive in vitro and in vivo studies. These data further highlight DURAVYU's multi-mechanism of action and its potential to bring a synergistic anti-inflammatory effect to the established VEGFR and PDGF inhibition for treatment of wet AMD and DME. Presented data at ARVO 2026 highlighting positive efficacy and safety outcomes from the Phase 2 clinical trials evaluating DURAVYU in wet AMD (DAVIO 2) and DME (VERONA). In both trials, a single dose of DURAVYU demonstrated durable efficacy, with improved vision and strong anatomical control. Further, the data supports a favorable safety profile with no safety signals or DURAVYU-related ocular or systemic SAEs. Review of Results for the First Quarter Ended March 31, 2026 For the first quarter ended March 31, 2026, total net revenue was $0.7 million compared to $24.5 million for the corresponding period in 2025. The decrease was primarily driven by the recognition of remaining deferred revenue related to the Company’s 2023 agreement for the license of YUTIQ® product rights. Operating expenses for the first quarter ended March 31, 2026, totaled $87.9 million versus $73.3 million in the prior year period. This increase was primarily attributable to ongoing DURAVYU Phase 3 clinical trials for wet AMD and DME and scale-up of our commercial manufacturing facility. Net non-operating income totaled $2.3 million and net loss was $84.8 million, or ($0.99) per share, compared to a net loss of $45.2 million, or ($0.65) per share, for the corresponding period in 2025. Cash, cash equivalents, and marketable securities as of March 31, 2026, totaled $223 million compared to $306 million as of December 31, 2025. Financial Outlook We expect the cash, cash equivalents, and marketable securities as of March 31, 2026, will enable us to fund operations into the fourth quarter of 2027 beyond key milestones for the Phase 3 wet AMD program in 2026. Conference Call Information EyePoint will host a conference call today at 8:30 a.m. ET to discuss the results for the first quarter ended March 31, 2026, and recent corporate developments. To access the live conference call, please register at https://edge.media-server.com/mmc/p/hjmg6gw2. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepoint.bio. A webcast replay will also be available on the corporate website at the conclusion of the call. About EyePoint 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 lead product candidate, DURAVYU™, is an innovative investigational sustained delivery treatment for serious retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor, in next-generation bioerodible Durasert E™ technology. Supported by robust safety and efficacy data across multiple clinical trials and indications, DURAVYU is currently being evaluated in Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Topline data is expected for wet AMD beginning in mid-2026. The Company is committed to partnering with the retina community to improve patient lives while creating long-term value, with four approved drugs over three decades and tens of thousands of eyes treated with EyePoint innovation. EyePoint is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Forward Looking Statements EYEPOINT SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our expectations regarding our clinical development and regulatory plans; our belief that DURAVYU™ is well-positioned to be the first-to-market among all investigational sustained release treatments for the two largest retinal disease markets, wet AMD and DME; our belief that DURAVYU is the only TKI in development for DME; our belief that DURAVYU is uniquely positioned to potentially address both VEGF-mediated vascular leakage and IL-6 mediated inflammatory drivers of DME as a sustained delivery therapy; our belief that DURAVYU’s potential real-world application in multiple retinal disease indications and established trial designs position DURAVYU for clinical and commercial success; our expectations regarding the timing of the availability and release of wet AMD and DME clinical data; our financial position and expected cash runway; our belief that DURAVYU has the potential to maintain a majority of patients with active disease with no supplemental anti-VEGF therapy for six months or longer; our beliefs regarding the potential market opportunity for DURAVYU in wet AMD and DME; our ability to continue to scale operations at our commercial manufacturing facility in Northbridge, Massachusetts; our expectations that our manufacturing facility will continue to meet FDA and EMA standards and support commercialization efforts of DURAVYU upon regulatory approval; and our expectations regarding the timing and clinical development of our other product candidates; and other statements regarding the Company’s future plans, objectives, strategies and beliefs, as identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” or other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the Company’s clinical development activities; uncertainties and delays relating to communications with the U.S. Food and Drug Administration and the ability to obtain regulatory approval from FDA for the commercialization of DURAVYU; unanticipated costs and expenses; the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; 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 the Company’s product candidates; changes in the regulatory environment; disruptions at the FDA; changes in U.S. and international trade policies; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates, including due to unanticipated regulatory compliance issues or warning letters relating to the Company’s manufacturing facilities; the availability of and the need for additional financing; our ability to obtain additional funding to support our clinical development programs; our ability to enter into a settlement agreement and corporate integrity agreement with the government regarding the DOJ investigation and uncertainties related to the impact such agreements would have on our business, financial condition and operations; uncertainties regarding the FDA warning letter pertaining to the Company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. 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. A more complete discussion of the risks and uncertainties that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in our most recent Annual Report on Form 10-K, in our other filings with the Securities and Exchange Commission (SEC) and in our future reports to be filed with the SEC, which are available at www.sec.gov. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors: Tanner Kaufman / Jenni Lu FTI Consulting Direct: 203-722-8743 / 667-321-6018 [email protected] / [email protected] Media Contact: Green Room Communications Direct: 850-384-2833 [email protected]

TranscriptFY2026 Q12026-05-06

FY2026 Q1 earnings call transcript

Earnings source - 85 paragraphs
Operator

Good morning. My name is Brittany, and I'll be your conference operator today. At this time, I would like to welcome everyone to the EyePoint First Quarter 2026 financial results and recent corporate development conference call. There will be a question and answer session to follow the completion of prepared remarks. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of EyePoint.

George Elston

Thank you, and thank you all for joining us on today's conference call to discuss EyePoint's first quarter 2026 financial results and recent corporate developments. With me today is Dr. Jay S. Duker, President and Chief Executive Officer of EyePoint. Jay will begin with a review of recent corporate updates and discuss our ongoing clinical programs for DURAVYU and wet AMD and DME. I will close with commentary on the first quarter 2026 financial results. We will open the call for your questions, where we will be joined by Dr. Ramiro Ribeiro, our Chief Medical Officer, and Michael Campbell, our Chief Commercial Officer. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found in the Investor Relations tab on the company website, www.eyepoint.bio.

George Elston

Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory matters and timelines, the potential success of our products and product candidates, financial projections, and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is on file with the SEC, and in other filings that we have made or may make with the SEC in the future. Any forward-looking statements represent our views as of today only.

George Elston

While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of EyePoint.

Jay Duker

Thank you, George. Good morning, everyone, and thank you for joining us. The start of 2026 for EyePoint was marked by a strong quarter of consistent execution as we approach a pivotal inflection point for our lead program, DURAVYU. We have strong conviction that the upcoming LUGANO and LUCIA readouts will catalyze our future transition into a fully integrated biopharmaceutical company, furthering our mission of improving the lives of patients with serious retinal disease. We remain on track to deliver these phase III top-line data in wet age-related macular degeneration, or wet AMD, beginning mid-year, positioning us to potentially be the first to market among all current investigational sustained release programs.

Jay Duker

In diabetic macular edema, or DME, we are seeing strong momentum in our Phase III program, with enrollment rapidly progressing to support our ambitious goal of full enrollment in both pivotal trials in the third quarter of 2026. As we advance towards these significant milestones, we are confident that our clinically rigorous, de-risked, and patient-centric approach will continue to reinforce DURAVYU's best-in-class potential in the two largest retinal disease markets. The fundamental strength of the DURAVYU program lies in its robust and differentiated clinical data. In Phase II trials, a single dose of DURAVYU demonstrated durable efficacy with improved vision and tight anatomic control. In over 190 patients across four completed clinical trials, DURAVYU has demonstrated a consistently favorable safety profile with no safety signals.

Jay Duker

That profile continues to hold in our ongoing phase III LUGANO and LUCIA trials for wet AMD as observed on a mass basis, where our low discontinuation rate of about 5% remains well below the 10% yearly average typical for wet AMD trials. None of these discontinuations were related to treatment. At this stage, all patients across the LUGANO and LUCIA trials have reached the week 32 visit, during which patients in the DURAVYU arms received their second DURAVYU dose. Over 35% of those patients have since received their third planned dose of DURAVYU at week 56. We've received 2 consecutive positive recommendations from the Independent Data and Safety Monitoring Committee, with a third review scheduled for later this month. We are optimistic that the interim mass safety data will continue to remain consistent, further strengthening DURAVYU's clinical profile.

Jay Duker

In addition, we believe the multi-mechanism of action, or MOA, of DURAVYU's active ingredient, vorolanib, will prove to be a key clinical differentiator. Along with blocking all VEGF isoforms and PDGF at the receptor level, preclinical data supports vorolanib's ability to inhibit IL-6 signaling via the JAK1 receptor. With this unique ability to not only address both the vascular leakage and inflammation that contributes to retinal disease pathogenesis, but also potentially provide sustained-release efficacy, DURAVYU is uniquely designed to deliver wide-reaching therapeutic potential. Earlier this week, we presented peer-reviewed data at the Association for Research in Vision and Ophthalmology, or ARVO meeting, that reinforces these findings and further substantiate DURAVYU's potential to improve long-term outcomes for patients. A primary kinase screen and subsequent measure of IC50 levels identified vorolanib as a potent inhibitor of JAK1, which plays a critical role in IL-6-mediated inflammation.

Jay Duker

In addition, vorolanib proved to be a potent inhibitor of IL-6 leakage in an in vitro cellular model. This data further highlights the multi-MOA potential of DURAVYU, with the opportunity to bring a synergistic anti-inflammatory effect in addition to established VEGF and PDGF inhibition to the treatment of wet AMD and DME. As we near top-line data for our Phase III wet AMD program, it's worth remembering the key elements underpinning its thoughtful design. Our approach is de-risked following an established non-inferiority regulatory pathway. Both pivotal trials are identical and compare DURAVYU to on-label 2-milligram aflibercept, which is intended to reflect real-world practice and generate clinically relevant data to inform the retina community. Additionally, both trials are evaluating 6-month redosing and statistical superiority in treatment burden reduction to support the potential for a compelling label that addresses the need for effective, durable disease control.

Jay Duker

Taken together, we believe our Phase III program is well-positioned to deliver data that will build upon our positive clinical development track record and contribute to strong commercial positioning for DURAVYU if approved. We look forward to reporting top-line data from our Phase III wet AMD trial, LUGANO, this summer, with our second trial, LUCIA, to follow shortly thereafter. We are applying the same de-risked approach to our Phase III DME program, which leverages a non-inferiority design, an on-label 2-milligram aflibercept control, and redosing every 6 months. Similar to our wet AMD program, we designed our pivotal trials for DME based on impressive data from the Phase II VERONA study, in which DURAVYU demonstrated rapid efficacy with 4 to 5 letters of vision improvement and approximately 50-micron improvement in anatomic control compared to aflibercept at week 4.

Jay Duker

Both of our DME trials, COMO and CAPRI, are now underway, with over one-third of patients enrolled across both trials following first patient dosing at the end of February of this year. Our strong pace of enrollment is driven by our ability to leverage our preexisting clinical trial infrastructure and investigator network, as well as the significantly smaller trial size compared to our wet AMD program. We expect top-line data in the second half of 2027. Stepping back, both wet AMD and DME together represent the vast majority of the global branded retinal disease treatment market, with a combined branded opportunity totaling nearly $15 billion in the U.S. and growing. Through exceptional clinical leadership and commitment to serving the retinal community, we are positioning DURAVYU to become a durable franchise with blockbuster potential.

Jay Duker

With a unique multi-MOA, robust clinical data package, proven delivery technology, the ability to be shipped and stored at ambient temperatures, and administration via standard in-office intravitreal injection, DURAVYU represents a compelling and truly innovative product profile that has the potential to reshape the treatment paradigm for serious retinal diseases. We continue to make significant strides in our commercial readiness while remaining disciplined in our investments as we prepare for regulatory submission. We have thoughtfully grown our organization with the addition of Michael Campbell as Chief Commercial Officer last quarter. In addition to expansion across key areas such as marketing and market access, regulatory, compliance, and medical affairs to build on our organizational capabilities as we advance our launch planning and strategy for DURAVYU in wet AMD. In addition to progress on our commercial readiness activities, we continue to prioritize CMC readiness.

Jay Duker

Our cGMP facility in Northbridge, Massachusetts, has been online for over a year, supporting our plans for an anticipated CMC submission for our potential new drug application, or NDA, as well as for commercial supply if approved. We continue to prepare for pre-approval inspection, underscoring our growing independent commercial readiness that we believe will ensure our preparedness to deliver DURAVYU to patients upon potential approval. Before passing it over to George to review the financials, I'd like to thank the entire EyePoint team for your unwavering commitment to improving quality of retinal care. We are proud to support the retina community and grateful to the patients, study coordinators, and clinical investigators who enable our research. We look forward to our upcoming Phase III wet AMD readouts, together with continued progress in our DME program, which we believe sets the stage for meaningful value creation at EyePoint.

Jay Duker

I will now turn the call over to George.

George Elston

Thank you, Jay. As the financial results for the three months ended March 31st, 2026 were included in the press release issued this morning, my comments today will be focused on a high-level review for the quarter. Importantly, we continued our disciplined financial management and good stewardship of our resources, ending the 1st quarter with $223 million in cash and investments. For the quarter ended March 31st, 2026, total net revenue was $0.7 million, compared to $24.5 million for the quarter ended March 31st, 2025. The decrease was primarily driven by the recognition of remaining deferred revenue related to the company's agreement in the 2nd quarter of 2023 for the license of YUTIQ product rights. Operating expenses for the quarter ended March 31st, 2026 totaled $88 million, compared to $73 million in the prior year period.

George Elston

This increase was primarily driven by the ongoing phase III trials for DURAVYU in both wet AMD and DME and the scale-up of our Northbridge commercial manufacturing facility. Net non-operating income totaled $2 million. Net loss was $85 million or $0.99 per share, compared to a net loss of $45 million or $0.65 per share for the prior year period. As I noted earlier, cash equivalents, and investments in marketable securities on March 31, 2026 totaled $223 million compared to $306 million as of December 31, 2025. We continue to expect that our current cash position will enable us to fund operations into the fourth quarter of 2027 beyond key milestones for the phase III wet AMD program expected later this year.

George Elston

In conclusion, we're pleased with EyePoint's progress so far in 2026 and remain well-capitalized to deliver DURAVYU through key value-driving milestones in the 2 largest retinal disease markets. I will now turn the call back over to Jay for closing remarks.

Jay Duker

Thank you, George. As we continue to deliver on our key priorities for 2026, our team is focused on advancing preparations for the pivotal phase III top-line data readout in wet AMD expected mid-year and completing enrollment of our phase III DME program in the third quarter of this year. We believe TKIs represent the next frontier in retinal disease innovation, and we are proud to be advancing DURAVYU as a potential first and best-in-class option in the two largest retinal disease markets. Thank you all for your attention this morning. I will now turn the call back over to the operator for questions.

Operator

Thank you so much. As usual, we'll try and get to as many questions as we can through the course of the call. If you limit the number of questions you ask to 1, it will give others a fair chance to participate. Our first question comes from the line of Tessa Romero with JPMorgan.

Tessa Romero

Great. Thanks so much. Hey, guys. thanks for taking our question this morning. just one from us. on the DME side, actually. for your COMO in the pre-trials, you talked a bit about your swift pace of enrollment here. Can you speak to what you're hearing from the investigators in terms of the level of interest from both patients and physicians around a TKI sustained delivery treatment option like DURAVYU? What are the key differences and similarities that you hear in the DME space versus maybe what you heard in the wet AMD space? Thanks so much.

Jay Duker

Thanks for the question, Tess. Given that our CMO, Ramiro Ribeiro, was really at the forefront of this, I'll ask him to answer your question.

Ramiro Ribeiro

Hey, Tess. Good morning. Thanks for the question. First, as you mentioned, we are seeing great excitement around our DME program, COMO, CAPRI, with a quite quick enrollment so far. We are now leveraging all the infrastructure that we use for our wet AMD with our clinical sites and our CRO and vendor as well. The feedback that we're getting from the investigators, very similar to our wet AMD, is that our study is a very patient-centric study trying to address a very important unmet need, which is the treatment burden. Patients that are participating in this study are very excited for a therapy that can last for about 6 months. In particular, for the DME indication, we know that the need for this patient population might be even greater than wet AMD.

Ramiro Ribeiro

This is a patient population that is relatively younger, and they are still in the workplace. A therapy that can reduce the number of visits like DURAVYU is, of course, of very interest for this patient population. Again, I think the excitement both from the investigators, the patient, the clinical sites, is being reflected in the pace of our enrollment.

Jay Duker

I'd like to add just one more thought to this. We invited 90 of our wet AMD investigators to be investigators in the DME trials, and all 90 accepted. We believe that continues to show investigators' enthusiasm for the potential of DURAVYU.

Operator

Thank you. Thank you so much. One moment for our next question. Our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is now open.

Yigal Nochomovitz

Great. Thank you very much for taking the questions. I'm just wondering if you could comment on how the supplement trigger criteria are functioning in the phase III trial relative to the phase II trial, the DAVIO 2 trial. If you could also comment on what you would expect to be a meaningful supplement rate in the phase III trial that would be consistent with a strong commercial uptake. Thank you.

Jay Duker

Yigal, nice to hear from you. Thanks for the question. With respect to supplements, I'm gonna have Ramiro comment in a moment about how that is working in the trial. I think there's really 2 issues around the supplementation that people should understand. The first is that in the clinical trials, supplements will be handled statistically with sensitivity analyses that we will be doing when we submit the NDA. There is a rate of supplements, at least conceivably, above which the drug would not be considered to be working independently because of a high rate of supplements. In saying that, the FDA has never put a line in the sand as to what that level would be, because they wanna see the totality of the data.

Jay Duker

They want to see the safety and the efficacy otherwise. From a supplementation perspective, there is an important hurdle, which of course we need to get over, which is the non-inferior margin, which is the primary endpoint. If we are approved, then I think the commercial acceptance shifts to a very different place. In the real world, a supplement is not a failure. Doctors, I believe, if we are approved, will enjoy taking advantage of using two MOAs. That has been true across a lot of chronic diseases, where if two MOAs in treatment are available, using them synergistically is a potential advantage to patients. Now, obviously we haven't shown that yet in our trials, but we hope that that would be the case for the benefit of patients.

Jay Duker

My point about supplements in the real world, I'll give you again an example. If I've got a patient that I have to inject every 2 months with a biologic anti-VEGF, and let's hypothesize that DURAVYU is FDA approved, it's safe, it's tolerable, it has a label for every 6 months, and the patient gets shifted to DURAVYU for the next year with 2 injections. In addition, they receive 2 injections of a biologic. Well, it's a great win for everyone. The patient can go from every 2 months to every 3 months, from 6 injections to 4 injections, and that presumably the advantages of DURAVYU will be aligned with the patient and the doctor's interests.

Jay Duker

There's the regulatory hurdle that needs to be reached over supplements, and if that's reached, I believe that supplementation in the real world will have great latitude for acceptance.

Yigal Nochomovitz

Okay, thank you. Then if I could just ask one other follow-up on DME. Of course, you've mentioned IL-6 as a potentially interesting biomarker. Are any of those IL-6 biomarker endpoints formally embedded in the phase II DME program as sort of secondary endpoints that could help differentiate the product?

Jay Duker

I would say yes, but indirectly. Given that there is no way to measure in a patient in a clinical trial the direct effects on IL-6 or JAK1, we would be measuring the indirect effects. The indirect effects, of course, number 1 is visual acuity. What we hope to be doing in the long term is provide better visual acuity for patients. In DME, we may be able to provide it in the short term. Again, looking at the VERONA data, at week 4, the patients who received DURAVYU had better vision and drier retinas as early as week 4 compared to a 1 dose of aflibercept.

Jay Duker

We have set up the COMO and CAPRI trials to try to show that, and there is a secondary endpoint of visual acuity and OCT at week 4, given our drug is given at day 1 in the DME trials. That we hope to show that even if we're non-inferior and equivalent to EYLEA, but we can provide the benefit earlier with fewer injections, then we will be able to have a great advantage to patients and therefore a commercial success. There are other secondary endpoints that we can look at that are not direct measurements of IL-6 or JAK inhibition. For example, leakage on fluorescein angiography.

Jay Duker

You may recall that in the VERONA trial, we had a significant reduction in leakage as measured by an independent reading center, and it was dose-dependent, with the higher dose of 2.7 milligrams showing much greater leakage reduction compared to the lower dose and compared to the aflibercept control. That's the kind of secondary endpoint that if we can show reduction in leakage greater than aflibercept, I think the evidence would lead to that is due to IL-6 inhibition.

Yigal Nochomovitz

Thanks.

Operator

Thank you so much. Our next question comes from the line of Faisal Khurshid with Jefferies. Your line is now open.

Faisal Khurshid

Hey, guys. Thank you for taking the question. Just wanted to ask, in the ongoing wet AMD studies, are you guys able to see blinded rescue rates, and are those tracking in line with your expectations? Thank you.

Jay Duker

Thanks for the question, Faisal. Again, I'll let Ramiro talk about the supplementations and what we're seeing and what we're not seeing.

Ramiro Ribeiro

Hey, Faisal. Thanks for the question. There's a very small team at EyePoint that reviews the supplementation injections, and essentially to make sure that the clinical sites are following the protocol. We don't review aggregated supplement injection rate, and that's something that we don't disclose publicly.

Faisal Khurshid

Makes sense. Thank you for taking the question.

Jay Duker

Well, if I may add, we again, as Ramiro Ribeiro indicated, have no insight into the number of supplements, supplementation rate, et cetera, at this point. It's all masked. We do anticipate that the supplementation rates in the phase III trials will be less than what we saw in the phase II, for several reasons, again, due to the tightening of the supplement criteria, getting rid of the physician discretion in supplements, the reinjection at month 6, and the inclusion of the majority of naive patients. All of those together should result in fewer supplements in phase III.

Faisal Khurshid

That's helpful context. Thank you.

Operator

Thank you so much. One moment for our next question, please. Our next question comes from the line of Yatin Suneja with I'm sorry. Guggenheim. Your line is now open.

Eddie Hickman

Yeah. Hey, guys. This is Eddie on for Yatin. Thank you for taking my question. Thinking about the fixed-dose regimen that you guys are going after, are patients who are already dry with stable vision still receiving that third dose at week 56? If so, is there any incremental safety signal from redosing well-controlled patients? You know, further, has the FDA weighed in on how this complicates the retreatment redosing schedule? Thank you so much.

Jay Duker

Thanks, Eddie. Very good question. Yes, this is a fixed-dose regimen. It has nothing to do with whether the patient, at the time of their repeat dose of DURAVYU, is dry or wet or what the visual acuities are. Just like any drug, for example, take 2 mg Eylea, when it was first studied every 2 months, that was fixed dose, where they received that injection whether they were active or not. That's going to be true in our, in our trial. From the perspective of safety, you know, we've done extensive preclinical safety in animals. In rabbits, we never found the maximally tolerated dose of vorolanib, and we've injected a scaled dose of about 10 times higher than anything we could achieve in humans. We've also not found the maximally tolerated number of inserts in rabbits.

Jay Duker

From a safety perspective, we were not concerned about reinjection. Again, we are reviewing the masked safety. I will once again turn to Ramiro Ribeiro if he wants to comment on the upcoming DMC meeting that is gonna be occurring shortly.

Ramiro Ribeiro

No, thanks, and thanks, Eddie, for the question. As Jay mentioned, safety is something that is, of course, paramount for EyePoint, and we conduct ongoing safety review of the data. If you do the math, we have now have patients that reached that week 56 visit that you mentioned, which is the 3rd dose of EYP-1901, and we haven't seen anything different than what we saw before. We do have an upcoming DMC meeting the month of May, where the members will review our masked data. We look forward to provide updates after that meeting.

Eddie Hickman

Great. Thank you.

Operator

Thank you so much. Our next question comes from the line of Debanjana Chatterjee with JonesTrading. Your line is now open.

Debanjana Chatterjee

Hi. Thanks for taking my question. What have you seen in the masked safety data set so far? Has anything shifted your expectations going into the DSMB review that is scheduled for late May?

Jay Duker

Thanks for the question, Debanjana. We're not commenting on any individual SAEs or AEs. In total, I would say and repeat what Ramiro Ribeiro said, what we've seen so far is consistent with what we have seen in the prior four trials. No new safety concerns and no incidents that we haven't seen or expected from before. Again, Ramiro Ribeiro, I don't know if you wanna add any more color to what I said.

Ramiro Ribeiro

Yeah, no, I think just again to reiterate, safety, at EyePoint, is paramount. We internally, we review the data on an ongoing basis on a mass fashion. As Jay mentioned, we have no safety signal. We haven't detected anything that is new. The safety profile continues to be very similar to what we saw in our previous completed studies.

Debanjana Chatterjee

Thank you. Just a very quick follow-up. Can we expect any form of public update following the DCMD meeting?

Jay Duker

Yes. I think it's likely that we will give an update. Yes.

Debanjana Chatterjee

Thank you for taking the time. Bye.

Operator

Thank you so much. Our next question comes from the line of Lisa Walter with RBC Capital Markets. Your line is now open.

Lisa Walter

Good morning. Thanks for taking our question, and congrats on the progress. We have seen a long-acting TKI competitor have a successful readout of their pivotal study earlier this year, and we've heard their plan is to file with the FDA and seek approval on this trial alone. In a scenario where essentially both yours and the other long-acting TKI are being launched within similar time frames, does perhaps having two products with the same mechanism of action actually help break into a market which already has an established therapeutic base with the anti-VEGF? How should we think about this? Thanks again.

Jay Duker

Yeah, Lisa, thanks for the question. It's a great question, and I think you've really hit on a very important point. The TKIs are going into a multi-billion dollar market, and there is certainly room for two competitors to both be very successful in this very large market. There is evidence from, as I think you're alluding to, from other launches with new mechanism of action into an established space that having more than one entry really helps both because doctors are hearing it and learning about it from multiple places. We welcome another competitor, and part of that is we believe we've got a better drug and a better delivery system.

Jay Duker

Hopefully, if both are FDA approved, we will have the opportunity, from a commercial basis, to really show that.

Operator

Hi, Lisa.

Lisa Walter

Thanks for taking my question. Appreciate the feedback.

Jay Duker

Thanks, Lisa.

Operator

Thank you so much. Our next question comes from the line of Nick for Colleen Cossey with Baird. Your line is now open.

Nick Quartapella

Hey, everyone. It's Nick on for Colleen. Thanks for taking the question. Just at ARVO and other recent scientific conferences, wanted to ask what the takeaways were on DURAVYU sentiment among physicians, and if you got any learnings about how physicians intend on using DURAVYU upon a potential approval. Thank you.

Jay Duker

One point I'd like to make, and thanks for the question, Nick. One point I'd like to make about ARVO is we had a poster there, which showed another preclinical model of leakage induced by VEGF and IL-6. In that model, vorolanib, the active ingredient in EYP-1901, was able to suppress the inflammation induced by IL-6 and VEGF that is equal to an anti-VEGF and an anti-IL-6. Again, one more model that suggests that vorolanib does have potent anti-IL-6 activity through the JAK1 receptor. There was a lot of interest in that poster. A lot of KOLs saw it, and there were quite a number of comments. Ramiro Ribeiro met with multiple KOLs at ARVO, and I will let him weigh in on what the sentiment seems to be around EYP-1901.

Ramiro Ribeiro

Yeah, no, thanks, Nick, for the question. We had a very productive ARVO this year with several posters being presented, including the one that Jay just mentioned. We also had a few advisory board and some interactions with our phase III wet AMD and DME investigator. I think first on the sentiment of the clinical trials, I think everybody, of course, is very excited for the upcoming data for LUGANO and LUCIA. Mentions of, you know, this is gonna be the highlight of the retina space for the year of 2026. For DME, the investigators, again, reflect that this is a really well study plan, very patient-centric, and they were all excited about bringing the therapy for patients with DME.

Ramiro Ribeiro

In terms of future use of DURAVYU, as Jay mentioned previously in the call, they expressed the important unmet need that we're trying to address with DURAVYU. They see this, if we can replicate the results that we saw in the phase II study, as something that is going to be very meaningful for patients, especially for those patients that require frequent treatment.

Nick Quartapella

Great. Thanks, all. Thanks for taking the question. Congrats on the progress.

Ramiro Ribeiro

Thank you.

Operator

Thank you so much. Our next question will be coming from the line of Yale Jen with Laidlaw. Your line is now open.

Yale Jen

Good morning. Thanks for taking the questions. I just follow up a little bit on the commercial question earlier, which is that besides the TKIs, in terms of the long-acting biologics, the Vabysmo and the high dose Eylea, which one or you think you, DURAVYU, if approved, will be competing more or less? Any comment on that? Thanks.

Jay Duker

Thanks for the question, Yale. It's an important question because these are excellent medications that are multi-billion dollar drugs that are really helping many, many patients. I think the first point to be clear on is we're not another anti-VEGF biologic. We work at the receptor level. We have multi MOA, block VEGF, PDGF, and we do believe the inflammation related to IL-6 elevation, which is not something that they do. In addition, it looks like from our phase II data that at least two-thirds of the wet AMD population could be treated with our drug alone every six months, should physicians choose to do that. That's not something that we're seeing in the real world with those new medications.

Jay Duker

While there are extended durations where the real-world data is suggesting that most patients are getting about 1 or 2 extension from either of those drugs compared to what they were on before. That's great, we still believe that it leaves a lot of room in the market for a 6-month or longer medication. It's hard to predict which of those drugs will be, I don't want to say the winner because I think both drugs are doing well when we launch potentially. We again, our belief is that we can provide benefit greater than what either of those drugs can do for patients. We believe in the long term, we will achieve better visual acuity.

Jay Duker

Michael Campbell, our Chief Commercial Officer, I believe, is on the line, and I don't know if he's gonna maybe have any other comments. Now I think it's a little early to talk about commercial strategy, but maybe, Mike, you can talk a little bit about how you view the competition.

Mike Campbell

Yeah. Thank you for the question. The one point I would add is that, while we have these very good anti-VEGFs, longer-acting, you know, anti-VEGFs in the market, not only is the real-world data showing the extension that Jay mentioned around 8 days, we also look at what the retina specialists are saying in the community and where the needs are. If you look at the American Society of Retina Specialists, ASRS, every year, they put out a PAT survey. Very consistently, the number one need in wet AMD treatments that is reported from ASRS is still durability, even with the Vabysmo and Eylea HD in the market. To Jay's point, there is a very clear opportunity should DURAVYU be successful and be approved.

Mike Campbell

There's a very clear opportunity for room in this market for more durable agents.

Yale Jen

Thanks. Thanks a lot.

Operator

All right. Thank you so much. Our next question comes from the line of Yaron Werber with TD Cowen. Your line is now open.

Samuel Rollenhagen

Hi, guys. This is Sam on for Tara. Can you hear me?

Jay Duker

Yes. Hi, Sam.

Samuel Rollenhagen

Great. Well, thanks for taking our question, and congrats on another great enrollment update. I just wanted to ask on safety for the LUGANO data and if you could help us set some expectations there for what you're hoping to see. I guess besides avoiding some of the more serious back of the eye events, are there any other AEs where you think DURAVYU could be differentiated versus competitors? Then also it'd just be great if you could clarify how you are anticipating to disclose those safety data in the top line release. Will you be reporting all events or just those above a specific threshold? Thanks.

Jay Duker

Thanks for the question, Sam. Again, one of the hallmarks of the current anti-VEGF approved drugs with, you know, perhaps one exception, is they're quite safe. While patients and physicians will probably be willing to accept perhaps a few more AEs from a long-acting drug, there can't be a big difference. There's really a high bar that's out there for safety. The good news is that all our safety from our four reported trials shows no real increase in any SAE or AE that would preclude our drug from being widely accepted, in our opinion. From a safety perspective, again, a lot of the safety issues that can occur are injection-related.

Jay Duker

If you're reducing the number of injections that a patient gets, then you're likely, in the long term, to have fewer adverse events. We hope to be able to show that in our pivotal trials. From a reporting perspective, I don't know how granular the safety reporting will be initially, but we do expect to have complete AE tables when we present the data from LUGANO and LUCIA.

Samuel Rollenhagen

Got it. Very helpful. Thank you.

Operator

Thank you so much. I'm showing no further questions in the queue at this time. Ladies and gentlemen, thank you for participating in today's conference. This does conclude your program, and you may now disconnect. Everyone, have a great day.

Investor releaseQuarter not tagged2026-04-29

EyePoint to Report First Quarter 2026 Financial Results on May 6, 2026

GlobeNewswire
WATERTOWN, Mass., April 29, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced it will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, May 6, 2026 to report its first quarter 2026 financial results and highlight recent corporate developments. To access the live conference call, please register using the audio conference link: https://edge.media-server.com/mmc/p/hjmg6gw2. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepoint.bio. A webcast replay will also be available on the Company website at the conclusion of the call. About EyePoint 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 lead product candidate, DURAVYU™, is an innovative investigational sustained delivery treatment for serious retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor, in next-generation bioerodible Durasert E™ technology. Supported by robust safety and efficacy data across multiple clinical trials and indications, DURAVYU is currently being evaluated in Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Topline data is expected for wet AMD beginning in mid-2026. The Company is committed to partnering with the retina community to improve patient lives while creating long-term value, with four approved drugs over three decades and tens of thousands of eyes treated with EyePoint innovation. EyePoint is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Investors: Tanner Kaufman / Jenni…Read full document

WATERTOWN, Mass., April 29, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced it will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, May 6, 2026 to report its first quarter 2026 financial results and highlight recent corporate developments. To access the live conference call, please register using the audio conference link: https://edge.media-server.com/mmc/p/hjmg6gw2. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepoint.bio. A webcast replay will also be available on the Company website at the conclusion of the call. About EyePoint 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 lead product candidate, DURAVYU™, is an innovative investigational sustained delivery treatment for serious retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor, in next-generation bioerodible Durasert E™ technology. Supported by robust safety and efficacy data across multiple clinical trials and indications, DURAVYU is currently being evaluated in Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Topline data is expected for wet AMD beginning in mid-2026. The Company is committed to partnering with the retina community to improve patient lives while creating long-term value, with four approved drugs over three decades and tens of thousands of eyes treated with EyePoint innovation. EyePoint is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Investors: Tanner Kaufman / Jenni Lu FTI Consulting Direct: 203-722-8743 / 667-321-6018 [email protected] / [email protected] Media Contact: Green Room Communications Direct: 850-384-2833 [email protected]

Investor releaseQuarter not tagged2026-03-17

This Biotech Stock Up 700% Is Still a Top Holding Despite a $9.3 Million Sale Last Quarter

Motley Fool
Cormorant Asset Management disclosed a sale of 50,000 shares of Praxis Precision Medicines (NASDAQ:PRAX) in a February 17, 2026, SEC filing, with an estimated transaction value of $9.31 million based on the quarter’s average share price. According to a February 17, 2026, SEC filing, Cormorant Asset Management reduced its stake in Praxis Precision Medicines by 50,000 shares during the fourth quarter of 2025. The estimated value of the shares sold was $9.31 million, based on the average unadjusted closing price for the quarter. The quarter-end value of the PRAX stake increased by $227.00 million, a figure that includes both the impact of trading and price movement. Top holdings after the filing: NASDAQ:PRAX: $280.00 million (12.9% of AUM) NASDAQ:BBOT: $223.84 million (12.7% of AUM) NASDAQ:ABVX: $182.05 million (10.3% of AUM) NASDAQ:EYPT: $151.00 million (8.6% of AUM) NASDAQ:RAPP: $91.85 million (5.2% of AUM) As of Monday, PRAX shares were priced at $305.00, up a staggering 700% over the past year and well outperforming the S&P 500’s roughly 19% gain in the same period. Praxis Precision Medicines develops clinical-stage therapies for central nervous system disorders, with lead candidates targeting major depressive disorder, perimenopausal depression, essential tremor, and severe epilepsy. The firm operates a research-driven biopharmaceutical model, advancing proprietary drug candidates through clinical trials and entering into multiple license and collaboration agreements. It targets patients with neurological and psychiatric conditions, as well as healthcare providers and partners in the biotechnology and pharmaceutical sectors. Praxis Precision Medicines is a Boston-based biotechnology company focused on developing innovative therapies for neurological disorders characterized by neuronal imbalance. The company leverages a diversified pipeline of small molecules and antisense oligonucleotides, supported by strategic partnerships and licensing agreements. Its clinical-stage assets and specialized focus position it to address significant unmet medical needs in central nervous system therapeutics. When a biotech stock has such a staggering surge in a single year, trimming a position can be less about losing conviction and more about managing risk during a dramatic run. Praxis Precision Medicines has become one of the standout performers in the neuroscience biotec…Read full document

Cormorant Asset Management disclosed a sale of 50,000 shares of Praxis Precision Medicines (NASDAQ:PRAX) in a February 17, 2026, SEC filing, with an estimated transaction value of $9.31 million based on the quarter’s average share price. According to a February 17, 2026, SEC filing, Cormorant Asset Management reduced its stake in Praxis Precision Medicines by 50,000 shares during the fourth quarter of 2025. The estimated value of the shares sold was $9.31 million, based on the average unadjusted closing price for the quarter. The quarter-end value of the PRAX stake increased by $227.00 million, a figure that includes both the impact of trading and price movement. Top holdings after the filing: NASDAQ:PRAX: $280.00 million (12.9% of AUM) NASDAQ:BBOT: $223.84 million (12.7% of AUM) NASDAQ:ABVX: $182.05 million (10.3% of AUM) NASDAQ:EYPT: $151.00 million (8.6% of AUM) NASDAQ:RAPP: $91.85 million (5.2% of AUM) As of Monday, PRAX shares were priced at $305.00, up a staggering 700% over the past year and well outperforming the S&P 500’s roughly 19% gain in the same period. Praxis Precision Medicines develops clinical-stage therapies for central nervous system disorders, with lead candidates targeting major depressive disorder, perimenopausal depression, essential tremor, and severe epilepsy. The firm operates a research-driven biopharmaceutical model, advancing proprietary drug candidates through clinical trials and entering into multiple license and collaboration agreements. It targets patients with neurological and psychiatric conditions, as well as healthcare providers and partners in the biotechnology and pharmaceutical sectors. Praxis Precision Medicines is a Boston-based biotechnology company focused on developing innovative therapies for neurological disorders characterized by neuronal imbalance. The company leverages a diversified pipeline of small molecules and antisense oligonucleotides, supported by strategic partnerships and licensing agreements. Its clinical-stage assets and specialized focus position it to address significant unmet medical needs in central nervous system therapeutics. When a biotech stock has such a staggering surge in a single year, trimming a position can be less about losing conviction and more about managing risk during a dramatic run. Praxis Precision Medicines has become one of the standout performers in the neuroscience biotech space. The company is advancing multiple late-stage therapies targeting neurological disorders such as essential tremor and severe epilepsy. Two of its most advanced programs, ulixacaltamide and relutrigine, have already gotten regulatory review after the company submitted new drug applications to the FDA, positioning Praxis for a potential transition from a development-stage biotech to a commercial drug maker. Financially, the company appears well capitalized for that transition. Praxis finished 2025 with roughly $926 million in cash and investments and strengthened its balance sheet further with a $621 million public offering early in January, providing enough runway to fund operations into 2028, management says. Within the broader portfolio, Praxis represents the fund’s largest holding, ahead of other biotech bets such as Abivax and EyePoint Pharmaceutical and certainly suggesting Cormorant believes there could be further upside. Before you buy stock in Praxis Precision Medicines, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Praxis Precision Medicines wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $514,000!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,105,029!* Now, it’s worth noting Stock Advisor’s total average return is 930% — a market-crushing outperformance compared to 187% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of March 16, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This Biotech Stock Up 700% Is Still a Top Holding Despite a $9.3 Million Sale Last Quarter was originally published by The Motley Fool

As of 2026-08-08 • Updated weeklySource: Earnings sourceIngestion runbook