EyePoint Reports First Quarter 2025 Financial Results and Highlights Recent Corporate Developments
EyePoint Pharmaceuticals (EYPT) reported strong progress in Q1 2025, with their Phase 3 DURAVYU trials for wet AMD showing exceptional enrollment rates. The LUGANO trial has reached over 90% enrollment and LUCIA over 50%, with both expected to complete enrollment in 2H 2025. The company reported total net revenue of $24.5 million, up from $11.7 million in Q1 2024, primarily driven by YUTIQ licensing revenue.
The company maintains a strong financial position with $318.2 million in cash and equivalents, providing runway into 2027. Operating expenses increased to $73.3 million, mainly due to accelerated trial enrollment. Net loss was $45.2 million ($0.65 per share). DURAVYU demonstrated promising results in Phase 2 VERONA trial for diabetic macular edema, showing significant vision improvement and fluid reduction compared to aflibercept control.
EyePoint Pharmaceuticals (EYPT) ha riportato notevoli progressi nel primo trimestre del 2025, con le prove di Fase 3 DURAVYU per la degenerazione maculare umida (wet AMD) che mostrano tassi di arruolamento eccezionali. Il trial LUGANO ha raggiunto oltre il 90% di arruolamento e LUCIA oltre il 50%, e si prevede che entrambi completino l'arruolamento nella seconda metà del 2025. L'azienda ha registrato un ricavo netto totale di 24,5 milioni di dollari, in aumento rispetto agli 11,7 milioni del primo trimestre 2024, principalmente grazie ai ricavi derivanti dalla licenza di YUTIQ.
L'azienda mantiene una solida posizione finanziaria con 318,2 milioni di dollari in liquidità e equivalenti, garantendo risorse fino al 2027. Le spese operative sono aumentate a 73,3 milioni di dollari, principalmente a causa dell'accelerazione nell'arruolamento dei trial. La perdita netta è stata di 45,2 milioni di dollari (0,65 dollari per azione). DURAVYU ha mostrato risultati promettenti nel trial di Fase 2 VERONA per l'edema maculare diabetico, evidenziando un significativo miglioramento della vista e una riduzione del fluido rispetto al controllo con aflibercept.
EyePoint Pharmaceuticals (EYPT) reportó un fuerte avance en el primer trimestre de 2025, con sus ensayos de Fase 3 DURAVYU para la DMAE húmeda mostrando tasas excepcionales de inscripción. El ensayo LUGANO ha alcanzado más del 90% de inscripción y LUCIA más del 50%, y se espera que ambos completen la inscripción en la segunda mitad de 2025. La compañía reportó ingresos netos totales de 24,5 millones de dólares, frente a 11,7 millones en el primer trimestre de 2024, impulsados principalmente por los ingresos por licencias de YUTIQ.
La empresa mantiene una sólida posición financiera con 318,2 millones de dólares en efectivo y equivalentes, lo que proporciona recursos hasta 2027. Los gastos operativos aumentaron a 73,3 millones, principalmente debido a la aceleración en la inscripción de ensayos. La pérdida neta fue de 45,2 millones de dólares (0,65 dólares por acción). DURAVYU demostró resultados prometedores en el ensayo de Fase 2 VERONA para el edema macular diabético, mostrando una mejora significativa en la visión y reducción de fluidos en comparación con el control de aflibercept.
EyePoint Pharmaceuticals(EYPT)는 2025년 1분기 강력한 진전을 보고했으며, 습성 황반변성(wet AMD)을 위한 3상 DURAVYU 임상시험에서 뛰어난 등록률을 기록했습니다. LUGANO 임상은 90% 이상의 등록률을 달성했으며 LUCIA는 50% 이상을 기록했으며, 두 임상 모두 2025년 하반기에 등록을 완료할 것으로 예상됩니다. 회사는 총 순매출 2,450만 달러를 보고했으며, 이는 2024년 1분기의 1,170만 달러에서 크게 증가했으며 주로 YUTIQ 라이선스 수익에 기인합니다.
회사는 3억 1,820만 달러의 현금 및 현금성 자산을 보유해 2027년까지 운영 자금을 확보하고 있습니다. 운영비용은 임상 등록 가속화로 인해 7,330만 달러로 증가했습니다. 순손실은 4,520만 달러(주당 0.65달러)였습니다. DURAVYU는 당뇨병성 황반부종을 위한 2상 VERONA 임상시험에서 유망한 결과를 보여, aflibercept 대조군 대비 시력 개선과 체액 감소가 크게 나타났습니다.
EyePoint Pharmaceuticals (EYPT) a annoncé de solides progrès au premier trimestre 2025, avec leurs essais de phase 3 DURAVYU pour la DMLA humide affichant des taux d'inscription exceptionnels. L'essai LUGANO a atteint plus de 90 % d'inscription et LUCIA plus de 50 %, les deux devant terminer l'inscription au second semestre 2025. La société a rapporté un chiffre d'affaires net total de 24,5 millions de dollars, en hausse par rapport à 11,7 millions au premier trimestre 2024, principalement grâce aux revenus de licence de YUTIQ.
La société maintient une solide position financière avec 318,2 millions de dollars en liquidités et équivalents, assurant une trésorerie jusqu'en 2027. Les dépenses d'exploitation ont augmenté à 73,3 millions, principalement en raison de l'accélération de l'inscription aux essais. La perte nette s'élève à 45,2 millions de dollars (0,65 dollar par action). DURAVYU a montré des résultats prometteurs dans l'essai de phase 2 VERONA pour l'œdème maculaire diabétique, avec une amélioration significative de la vision et une réduction des fluides par rapport au contrôle aflibercept.
EyePoint Pharmaceuticals (EYPT) meldete starke Fortschritte im ersten Quartal 2025, wobei ihre Phase-3 DURAVYU-Studien für feuchte AMD außergewöhnliche Einschreibungsraten aufweisen. Die LUGANO-Studie hat über 90% Einschreibung erreicht und LUCIA über 50%, wobei beide voraussichtlich im zweiten Halbjahr 2025 die Einschreibung abschließen werden. Das Unternehmen berichtete von einem Nettoumsatz von 24,5 Millionen US-Dollar, gegenüber 11,7 Millionen US-Dollar im ersten Quartal 2024, hauptsächlich getrieben durch Lizenzerlöse von YUTIQ.
Das Unternehmen hält eine starke finanzielle Position mit 318,2 Millionen US-Dollar an liquiden Mitteln und Äquivalenten, was eine Finanzierung bis ins Jahr 2027 sichert. Die Betriebsausgaben stiegen auf 73,3 Millionen US-Dollar, hauptsächlich aufgrund der beschleunigten Studieneinschreibung. Der Nettoverlust betrug 45,2 Millionen US-Dollar (0,65 US-Dollar pro Aktie). DURAVYU zeigte vielversprechende Ergebnisse in der Phase-2 VERONA-Studie bei diabetischem Makulaödem mit signifikanter Verbesserung des Sehvermögens und Flüssigkeitsreduktion im Vergleich zur Aflibercept-Kontrollgruppe.
- Strong enrollment progress in Phase 3 trials with LUGANO at 90% and LUCIA at 50% enrollment
- Robust cash position of $318.2M providing runway into 2027
- Total net revenue increased 109% YoY to $24.5M from $11.7M
- Positive Phase 2 VERONA trial results showing superior efficacy vs aflibercept in DME patients
- Operating expenses increased 63% YoY to $73.3M from $45.0M
- Net loss widened to $45.2M from $29.3M YoY
- Cash position decreased from $371M to $318.2M quarter-over-quarter
Insights
EyePoint's accelerated DURAVYU trial enrollment and strong cash position outweigh increased R&D expenses, positioning it favorably against competitors.
EyePoint's first quarter results highlight exceptional enrollment progress in their Phase 3 DURAVYU wet AMD program, with 90% of patients randomized in LUGANO and 50% in LUCIA. This accelerated pace suggests strong physician and patient interest in this sustained-release treatment, significantly outperforming historical recruitment rates for comparable trials. Both trials remain on track to complete enrollment in 2H 2025, positioning DURAVYU with a potential first-mover advantage in the sustained-release wet AMD market.
The company reported
The $318.2 million cash position provides runway into 2027, comfortably beyond the anticipated Phase 3 data readouts in 2026. This financial cushion significantly de-risks the development program.
DURAVYU's clinical profile continues to strengthen, with Phase 2 VERONA DME trial data showing meaningful vision improvement and anatomical control. The subgroup analysis in supplement-free patients demonstrated particularly compelling results with BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control at week 24. This
With two blockbuster indications in focus (wet AMD and DME), six-month dosing potential, and a proven drug delivery platform, EyePoint is establishing itself as a leader in sustained-release ocular therapeutics while maintaining sufficient capital to execute through critical value-creating milestones.
– Enrollment continues to exceed expectations in DURAVYU™ Phase 3 wet AMD clinical trials with over
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WATERTOWN, Mass., May 07, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, 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, 2025, and highlighted recent corporate developments.
“We continue to make outstanding progress with our two Phase 3 pivotal trials for DURAVYU in wet age-related macular degeneration (AMD) and have already randomized over
“In addition, we reported compelling efficacy and safety data from our Phase 2 VERONA trial in diabetic macular edema (DME) earlier this year, further reinforcing our confidence in DURAVYU as a potential paradigm-shifting treatment for patients suffering from serious retinal diseases. DURAVYU has the most robust efficacy profile and favorable safety dataset across all sustained release programs in development in two blockbuster indications. The impressive data for DURAVYU, along with a strong cash position, and proven Durasert® technology further positions EyePoint as the leader in ocular sustained drug delivery,” added Dr. Duker.
R&D Highlights and Updates
- Phase 3 pivotal LUGANO and LUCIA trials for DURAVYU in wet AMD are exceeding enrollment expectations and the Company is on track to complete enrollment for both in the second half of 2025. The rapid enrollment to date continues to exceed the observed recruitment rates of comparable historical and ongoing wet AMD clinical trials with LUGANO and LUCIA having randomized over
90% and50% of patients, respectively, into the trials. LUGANO and LUCIA are identical, global non-inferiority trials with every six-month re-dosing following a clear and recognized pathway for regulatory and commercial success, positioning DURAVYU to become a potential blockbuster franchise. - The Phase 2 VERONA clinical trial of DURAVYU in DME met both primary and secondary endpoints. The 24-week data demonstrated a meaningful and sustained improvement in vision and anatomical control with a continued favorable safety profile.
- A subgroup analyses of supplement-free patients from the VERONA trial in DME demonstrated that DURAVYU 2.7mg significantly and rapidly (by week 4) improved vision and reduced fluid levels, demonstrating a BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control and a CST improvement of 117.4 microns versus 43.7 microns for aflibercept control at week 24. These results further underscore the differentiated profile of DURAVYU with compelling efficacy, favorable safety, and strong durability.
- Presented multiple datasets at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in early May 2025, demonstrating DURAVYU’s potential real-world application in multiple retinal disease indications and de-risked trial designs that position DURAVYU for clinical and commercial success. Presentations included:
- An assessment of the treatment burden in wet AMD treated with DURAVYU versus aflibercept from the Phase 2 DAVIO 2 clinical trial
- Trial design of the global LUGANO and LUCIA pivotal Phase 3 trials in wet AMD
- A 24-month Good Laboratory Practice (GLP) repeat-dose toxicology study of vorolanib intravitreal insert
- The 24-week topline results from the Phase 2 VERONA study in DME were accepted for presentation at the Retina World Congress in May 2025, which will highlight DURAVYU’s potential to transform the treatment landscape in the second largest retinal disease market with its best-in-class safety and efficacy profile.
Review of Results for the First Quarter Ended March 31, 2025
For the first quarter ended March 31, 2025, total net revenue was
Net revenue from license and royalties for the first quarter ended March 31, 2025, totaled
Operating expenses for the first quarter ended March 31, 2025, totaled
Cash, cash equivalents, and marketable securities as of March 31, 2025 totaled
Financial Outlook
EyePoint expects its cash, cash equivalents, and marketable securities as of March 31, 2025 will enable the Company to fund operations into 2027 beyond topline Phase 3 data for DURAVYU in wet AMD expected in 2026.
Conference Call Information
EyePoint management will host a conference call today at 8:30 a.m. ET to discuss the results for the first quarter ended March 31, 2025, and recent corporate developments. To access the live conference call, please register at https://register-conf.media-server.com/register/BI0695874f15d442e59e2fb362d4491cac. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.
About EyePoint
EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. Supported by robust safety and efficacy data to date, DURAVYU is presently in Phase 3 global, pivotal clinical trials for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States and recently completed a Phase 2 clinical trial in diabetic macular edema (DME).
Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products in multiple disease indications. EyePoint is headquartered in Watertown, Massachusetts, and operates a commercial-ready 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 candidate; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.
Forward Looking Statements
EYEPOINT PHARMACEUTICALS 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 of DURAVYU™; our belief that DURAVYU™ is on track to be the first-to-market of the current investigational sustained release treatments for wet AMD; our belief that DURAVYU™ has two potential blockbuster indications; our belief that DURAVYU™’s potential real-world application in multiple retinal disease indications and de-risked trial designs position DURAVYU™ for clinical and commercial success; our expectations regarding timing for the completion of clinical trial enrollment and the timing of the availability and release of clinical data; our belief that rapid trial enrollment in LUGANO and LUCIA highlights physician and patient enthusiasm for DURAVYU™, which we believe is driven by an established and familiar trial design, robust Phase 2 data, and a strong safety profile; our expectations regarding cash runway; our optimism that that DURAVYU™ has the potential to shift the treatment paradigm in wet AMD and DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our belief that we are well positioned as the leader in ocular sustained drug delivery; our business strategies and objectives; 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, including DURAVYU™; 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, including due to a reduction in the FDA’s workforce and/or inadequate funding for 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; the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; 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:
Christina Tartaglia
Precision AQ
Direct: 212-698-8700
christina.tartaglia@precisionaq.com
Media Contact:
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com
| EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES | ||||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||||
| (In thousands) | ||||||||||
| March 31, | December 31, | |||||||||
| 2025 | 2024 | |||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 85,158 | $ | 99,704 | ||||||
| Marketable securities | 233,036 | 271,209 | ||||||||
| Accounts and other receivables, net | 442 | 607 | ||||||||
| Prepaid expenses and other current assets | 6,218 | 9,481 | ||||||||
| Inventory | 2,129 | 2,305 | ||||||||
| Total current assets | 326,983 | 383,306 | ||||||||
| Operating lease right-of-use assets | 21,510 | 21,000 | ||||||||
| Other assets | 14,071 | 14,159 | ||||||||
| Total assets | $ | 362,564 | $ | 418,465 | ||||||
| Liabilities and stockholders' equity | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable and accrued expenses | $ | 34,597 | $ | 29,824 | ||||||
| Deferred revenue | 5,115 | 17,784 | ||||||||
| Other current liabilities | 1,965 | 1,440 | ||||||||
| Total current liabilities | 41,677 | 49,048 | ||||||||
| Deferred revenue - noncurrent | - | 10,853 | ||||||||
| Operating lease liabilities - noncurrent | 22,314 | 21,858 | ||||||||
| Other noncurrent liabilities | 177 | 205 | ||||||||
| Total liabilities | 64,168 | 81,964 | ||||||||
| Stockholders' equity: | ||||||||||
| Capital | 1,215,684 | 1,208,489 | ||||||||
| Accumulated deficit | (918,211 | ) | (873,016 | ) | ||||||
| Accumulated other comprehensive income | 923 | 1,028 | ||||||||
| Total stockholders' equity | 298,396 | 336,501 | ||||||||
| Total liabilities and stockholders' equity | $ | 362,564 | $ | 418,465 | ||||||
| EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES | ||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
| (In thousands, except per share data) | ||||||||||
| Three Months Ended | ||||||||||
| March 31, | ||||||||||
| 2025 | 2024 | |||||||||
| Revenues: | ||||||||||
| Product sales, net | $ | 715 | $ | 658 | ||||||
| License and collaboration agreements | 11,049 | 10,563 | ||||||||
| Royalty income | 12,689 | 463 | ||||||||
| Total revenues | 24,453 | 11,684 | ||||||||
| Operating expenses: | ||||||||||
| Cost of sales | 805 | 759 | ||||||||
| Research and development | 58,574 | 30,139 | ||||||||
| Sales and marketing | 35 | 6 | ||||||||
| General and administrative | 13,876 | 14,101 | ||||||||
| Total operating expenses | 73,290 | 45,005 | ||||||||
| Loss from operations | (48,837 | ) | (33,321 | ) | ||||||
| Other income (expense): | ||||||||||
| Interest and other income, net | 3,642 | 4,037 | ||||||||
| Total other income, net | 3,642 | 4,037 | ||||||||
| Net loss | $ | (45,195 | ) | $ | (29,284 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.65 | ) | $ | (0.55 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 69,767 | 52,913 | ||||||||
FAQ
What were EyePoint's (EYPT) Q1 2025 financial results?
What is the enrollment status of EYPT's DURAVYU Phase 3 trials?
How long will EyePoint's current cash position last?
What were the Phase 2 VERONA trial results for DURAVYU in DME patients?
When does EyePoint expect topline data from DURAVYU Phase 3 trials?
