EyePoint Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights Recent Corporate Developments
EyePoint Pharmaceuticals reported Q3 2024 financial results and corporate updates. Key highlights include positive interim data for DURAVYU 2.7mg in DME showing +8.9 letters BCVA improvement and -68 microns CST reduction at 16 weeks. The company initiated Phase 3 LUGANO trial for wet AMD and completed a $161M equity financing. Q3 revenue was $10.5M, down from $15.2M in Q3 2023. Net loss increased to $29.4M ($0.54 per share) from $12.6M ($0.33 per share) year-over-year. Cash position stands at $253.8M, with runway extended into 2027 following the recent financing.
EyePoint Pharmaceuticals ha riportato i risultati finanziari del terzo trimestre del 2024 e aggiornamenti aziendali. I punti salienti includono dati intermedi positivi per DURAVYU 2.7mg nella DME che mostrano un miglioramento del BCVA di +8,9 lettere e una riduzione CST di -68 micron a 16 settimane. L'azienda ha avviato la fase 3 della sperimentazione LUGANO per l'AMD umida e ha completato un finanziamento azionario di $161 milioni. I ricavi del terzo trimestre sono stati di $10,5 milioni, in calo rispetto ai $15,2 milioni del terzo trimestre del 2023. La perdita netta è aumentata a $29,4 milioni ($0,54 per azione) rispetto ai $12,6 milioni ($0,33 per azione) dell'anno precedente. La posizione di cassa è di $253,8 milioni, con una scorta finanziaria estesa fino al 2027 dopo il recente finanziamento.
EyePoint Pharmaceuticals reportó los resultados financieros del tercer trimestre de 2024 y actualizaciones corporativas. Los aspectos más destacados incluyen datos interinos positivos para DURAVYU 2.7mg en DME que muestran una mejora de +8.9 letras en BCVA y una reducción de -68 micrones en CST a las 16 semanas. La compañía inició el ensayo de Fase 3 LUGANO para la AMD húmeda y completó un financiamiento de capital de $161 millones. Los ingresos del tercer trimestre fueron de $10.5 millones, frente a los $15.2 millones en el tercer trimestre de 2023. La pérdida neta aumentó a $29.4 millones ($0.54 por acción) desde $12.6 millones ($0.33 por acción) en el año anterior. La posición de efectivo se sitúa en $253.8 millones, con un horizonte financiero extendido hasta 2027 tras el reciente financiamiento.
EyePoint Pharmaceuticals는 2024년 3분기 재무 결과 및 기업 업데이트를 보고했습니다. 주요 하이라이트로는 DME에서 DURAVYU 2.7mg의 긍정적인 중간 데이터가 +8.9자의 BCVA 개선 및 16주차에 -68 마이크론의 CST 감소를 보여주었습니다. 이 회사는 습성 AMD에 대한 3상 LUGANO 시험을 시작했으며 1억 6100만 달러의 자본 조달을 완료했습니다. 3분기 매출은 1,050만 달러로, 2023년 3분기 1,520만 달러에서 감소했습니다. 순손실은 지난해 같은 기간의 1,260만 달러($0.33 per 주식)에서 2,940만 달러($0.54 per 주식)로 증가했습니다. 현금 보유액은 2억 5,380만 달러이며, 최근 자금 조달 이후 2027년까지 자금 조달이 연장되었습니다.
EyePoint Pharmaceuticals a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour d'entreprise. Les points saillants incluent des données intermédiaires positives pour DURAVYU 2.7mg dans le DME montrant une amélioration de +8,9 lettres du BCVA et une réduction de -68 microns du CST à 16 semaines. La société a lancé l'essai de phase 3 LUGANO pour l'AMD humide et a complété un financement en actions de 161 millions de dollars. Les revenus du troisième trimestre se sont élevés à 10,5 millions de dollars, en baisse par rapport à 15,2 millions de dollars au troisième trimestre 2023. La perte nette a augmenté à 29,4 millions de dollars (0,54 $ par action) contre 12,6 millions de dollars (0,33 $ par action) d'une année sur l'autre. La position de trésorerie s'élève à 253,8 millions de dollars, avec une marge financière prolongée jusqu'en 2027 suite au financement récent.
EyePoint Pharmaceuticals hat die Finanzergebnisse für das 3. Quartal 2024 und Unternehmensupdates veröffentlicht. Zu den wichtigsten Highlights gehören positive Zwischenergebnisse für DURAVYU 2.7mg bei DME, die eine Verbesserung des BCVA um +8,9 Buchstaben und eine Reduzierung des CST um -68 Mikrometer nach 16 Wochen zeigen. Das Unternehmen hat die Phase-3-Studie LUGANO für feuchte AMD gestartet und eine Eigenkapitalfinanzierung in Höhe von 161 Millionen USD abgeschlossen. Die Einnahmen im 3. Quartal betrugen 10,5 Millionen USD, ein Rückgang gegenüber 15,2 Millionen USD im 3. Quartal 2023. Der Nettoverlust erhöhte sich auf 29,4 Millionen USD (0,54 USD pro Aktie) von 12,6 Millionen USD (0,33 USD pro Aktie) im Jahr zuvor. Die liquiden Mittel belaufen sich auf 253,8 Millionen USD, mit einer verlängerten Laufzeit bis 2027 nach der jüngsten Finanzierung.
- Positive interim DME trial data showing significant BCVA improvement of +8.9 letters
- Successful completion of $161M equity financing
- Extended cash runway into 2027
- Initiation of Phase 3 LUGANO trial in wet AMD
- Opening of new 40,000 sq ft cGMP manufacturing facility
- Revenue declined 31% YoY to $10.5M from $15.2M
- Net loss increased to $29.4M from $12.6M YoY
- Operating expenses increased to $43.3M from $29.6M YoY
- Cash position decreased to $253.8M from $331.1M since December 2023
Insights
The Q3 results reveal significant strategic developments for EyePoint. The
The cash position of
The interim VERONA trial data for DURAVYU 2.7mg in DME shows promising efficacy with +8.9 letters BCVA improvement versus +3.2 letters for aflibercept control at 16 weeks. The CST reduction of 68.1 microns versus 30.5 microns for control demonstrates strong anatomical improvement. The immediate bioavailability and sustained release profile could provide a significant competitive advantage in the retinal disease market.
The advancement of two Phase 3 trials (LUGANO and LUCIA) for wet AMD, with over 160 committed trial sites, positions DURAVYU™ for potential regulatory submission by 2026. The six-month dosing interval could significantly reduce treatment burden compared to current monthly/bi-monthly standards.
– Announced positive interim data for DURAVYU 2.7mg in DME demonstrating meaningful, early and sustained visual acuity gains, strong anatomical control and a continued favorable safety profile; BCVA and CST improvement of +8.9 letters and -68 microns, respectively, at 16-weeks –
– Dosed first patient in Phase 3 LUGANO pivotal non-inferiority clinical trial of DURAVYU™ in wet AMD; second LUCIA pivotal trial first patient dosing expected by end of 2024 –
–
WATERTOWN, Mass., Nov. 07, 2024 (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 third quarter ended September 30, 2024, and highlighted recent corporate developments.
“We made tremendous progress across our pipeline in recent months, including dosing the first patient in our first global pivotal trial of DURAVYU™ in wet AMD and reading out interim 16-week data for our Phase 2 VERONA trial in DME,” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint. “Driven by positive clinical data in two indications, along with growing patient and investigator enthusiasm, we remain confident that DURAVYU’s differentiated profile underscores its potential to be the first sustained-release maintenance therapy in two significant indications, positioning EyePoint as the leader in sustained ocular drug delivery. This is an exciting time for EyePoint, and we anticipate dosing the first patient in the second Phase 3 LUCIA trial by the end of 2024. With a strong balance sheet and compelling clinical data, we are well-positioned to continue executing across our pipeline, working to bring our potentially paradigm-shifting treatment to patients as fast as possible.”
R&D Highlights and Updates
- Announced positive interim 16-week data for the ongoing open label Phase 2 VERONA clinical trial of DURAVYU for diabetic macular edema (DME) in October. DURAVYU 2.7mg demonstrated an early, sustained, and clinically meaningful improvement in best-corrected visual acuity (BCVA) with a gain of +8.9 letters compared to baseline versus +3.2 letters for aflibercept control. DURAVYU 2.7mg also demonstrated concomitant structural improvement with CST (central subfield thickness) improvement of 68.1 microns versus 30.5 microns for aflibercept control. Notably, both DURAVYU doses showed an immediate benefit over aflibercept control in both BCVA and CST demonstrating the differentiated drug release profile of DURAVYU with immediate bioavailability. Additionally, a favorable safety and tolerability profile continued for both DURAVYU arms. The Company expects to report the full topline results in the first quarter of 2025, once all patients complete the trial.
- Announced first patient dosed in the Phase 3 LUGANO clinical trial of DURAVYUTM in wet age-related macular degeneration (wet AMD). The second Phase 3 LUCIA pivotal trial initiation is expected to have first patient dosing by end of 2024. The LUGANO and LUCIA clinical trials are designed for potential global regulatory and commercial success with every six-month re-dosing in both trials. With over 160 trial sites committed and robust DAVIO 2 data, the company anticipates rapid enrollment of both trials with topline data anticipated in 2026.
- Presented DAVIO 2 twelve-month data at the American Academy of Ophthalmology (AAO) 2024 Subspecialty Day in October, at the 24th EURetina Congress in September and the Retina Society 57th Annual Meeting in September.
- Presented a comparison of tyrosine kinase inhibitors being developed for intravitreal delivery at the Retina Society 57th Annual Meeting in September, demonstrating the differentiation of DURAVYU with immediate bioavailability and controlled release via zero-order kinetics for at least six months.
- Presented on sustained-release vorolanib highlighting selective pan-VEGF receptor inhibition and anti-angiogenic effects in VEGF-mediated ocular diseases at the American Retina Forum (ARF) 2024 National Meeting in August demonstrating the durable efficacy, reliable safety and reduced injection burden of treatment with DURAVYU.
Recent Corporate Highlights
- Completed an underwritten public offering with gross proceeds of
$161.0 million in October. The Company sold 14,636,363 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock. The shares of common stock were sold at a public offering price of$11.00 per share. - Announced the grand opening of EyePoint’s Northbridge, MA manufacturing facility in October. The 40,000 square foot Good Manufacturing Process (cGMP) compliant commercial manufacturing facility was built to meet U.S. FDA and European Medicines Agency (EMA) and will support global manufacturing across the Company’s portfolio, including lead pipeline asset, DURAVYUTM upon potential regulatory approval.
- Announced the appointment of esteemed industry leader Fred Hassan to the Company’s Board of Directors in September.
Review of Results for the Third Quarter Ended September 30, 2024
For the third quarter ended September 30, 2024, total net revenue was
Net revenue from royalties and collaborations for the third quarter ended September 30, 2024, totaled
Operating expenses for the third quarter ended September 30, 2024, totaled
Cash and investments at September 30, 2024 totaled
Financial Outlook
We expect the cash, cash equivalents and investments on September 30, 2024, along with the net proceeds from the October
About EyePoint Pharmaceuticals
EyePoint (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™ (f/k/a EYP-1901), 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™. DURAVYU is presently in Phase 3 global, pivotal clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and in a Phase 2 clinical trial in diabetic macular edema (DME). EyePoint expects full topline data from the Phase 2 clinical trial in DME in Q1 2025 and topline data from both Phase 3 pivotal trials in wet AMD in 2026.
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. EyePoint Pharmaceuticals is headquartered in Watertown, 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 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 the timing and clinical development and potential of DURAVYU in wet AMD and DME, including our expectations regarding the announcement of full topline data from the VERONA trial in the first quarter of 2025 and initiation of the LUGANO trial and the LUCIA trial; the belief that the interim results from the VERONA trial support DURAVYU’s potential to advance to non-inferiority pivotal trials; our beliefs and expectations regarding the anticipated full results from the VERONA trial; the potential for DURAVYU 2.7mg to extend treatment intervals while improving vision; the potential for DURAVYU to provide an immediate benefit over aflibercept control in both BCVA and CST; our optimism that that DURAVYU has the potential to shift the treatment paradigm in DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our business strategies and objectives; and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” 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 the design, enrollment, completion, and results of clinical trials; 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; 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. 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 (formerly Stern IR)
Direct: 212-698-8700
christina.tartaglia@sternir.com
Media Contact:
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com
| EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (In thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 79,830 | $ | 281,263 | ||||
| Marketable securities | 173,963 | 49,787 | ||||||
| Accounts and other receivables, net | 378 | 805 | ||||||
| Prepaid expenses and other current assets | 11,571 | 9,039 | ||||||
| Inventory | 2,807 | 3,906 | ||||||
| Total current assets | 268,549 | 344,800 | ||||||
| Operating lease right-of-use assets | 21,405 | 4,983 | ||||||
| Other assets | 10,963 | 5,401 | ||||||
| Total assets | $ | 300,917 | $ | 355,184 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 21,509 | $ | 24,025 | ||||
| Deferred revenue | 25,996 | 38,592 | ||||||
| Other current liabilities | 1,289 | 646 | ||||||
| Total current liabilities | 48,794 | 63,263 | ||||||
| Deferred revenue - noncurrent | 11,234 | 20,692 | ||||||
| Operating lease liabilities - noncurrent | 21,922 | 4,906 | ||||||
| Other noncurrent liabilities | 233 | - | ||||||
| Total liabilities | 82,183 | 88,861 | ||||||
| Stockholders' equity: | ||||||||
| Capital | 1,049,180 | 1,007,605 | ||||||
| Accumulated deficit | (831,617 | ) | (742,146 | ) | ||||
| Accumulated other comprehensive income | 1,171 | 864 | ||||||
| Total stockholders' equity | 218,734 | 266,323 | ||||||
| Total liabilities and stockholders' equity | $ | 300,917 | $ | 355,184 | ||||
| $ | — | $ | — | |||||
| EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Unaudited (In thousands, except per share data) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 664 | $ | 816 | $ | 2,390 | $ | 13,483 | ||||||||
| License and collaboration agreements | 9,561 | 14,137 | 27,906 | 17,768 | ||||||||||||
| Royalty income | 299 | 249 | 1,389 | 739 | ||||||||||||
| Total revenues | 10,524 | 15,202 | 31,685 | 31,990 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales | 736 | 1,202 | 2,896 | 3,634 | ||||||||||||
| Research and development | 29,542 | 17,363 | 89,554 | 46,711 | ||||||||||||
| Sales and marketing | 24 | 479 | 80 | 11,504 | ||||||||||||
| General and administrative | 12,970 | 10,556 | 39,770 | 28,854 | ||||||||||||
| Total operating expenses | 43,272 | 29,600 | 132,300 | 90,703 | ||||||||||||
| Loss from operations | (32,748 | ) | (14,398 | ) | (100,615 | ) | (58,713 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income, net | 3,387 | 1,786 | 11,144 | 4,611 | ||||||||||||
| Interest expense | - | - | - | (1,247 | ) | |||||||||||
| Loss on extinguishment of debt | - | - | - | (1,347 | ) | |||||||||||
| Total other income, net | 3,387 | 1,786 | 11,144 | 2,017 | ||||||||||||
| Net loss | $ | (29,361 | ) | $ | (12,612 | ) | $ | (89,471 | ) | $ | (56,696 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.54 | ) | $ | (0.33 | ) | $ | (1.67 | ) | $ | (1.50 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 54,449 | 38,341 | 53,526 | 37,804 | ||||||||||||
FAQ
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