EyePoint Pharmaceuticals Inc (EYPT) 2025 Q2 法說會逐字稿

Good morning. My name is Antoine, and I'll be your conference operator today. At this time, I would like to welcome everyone to the EyePoint second-quarter 2025 financial results and recent corporate developments conference call. (Operator Instructions) Please be advised that, this call is being recorded at the company's request.

早安.我叫安托萬，今天我將擔任您的會議接線生。現在，我歡迎大家參加 EyePoint 2025 年第二季財務業績和近期公司發展電話會議。（操作員指示）請注意，此通話是應公司要求錄音的。

I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of EyePoint.

現在我想將電話轉給 EyePoint 執行副總裁兼財務長 George Elston。

Thank you, and thank you all for joining us on today's conference call to discuss EyePoint's second-quarter 2025 financial results and recent corporate developments. With me today is Dr. Jay Duker, President and Chief Executive Officer of EyePoint. Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for DURAVYU in wet-AMD. I will close with commentary on the second-quarter 2025 financial results, and we will then open the call for your questions.

謝謝大家，也謝謝大家參加今天的電話會議，討論 EyePoint 2025 年第二季的財務業績和最近的公司發展。今天與我一起的還有 EyePoint 總裁兼執行長 Jay Duker 博士。Jay 將首先回顧該公司最近的最新動態，並討論 DURAVYU 治療濕性 AMD 的正在進行的臨床試驗。最後，我將對 2025 年第二季的財務表現進行評論，然後我們將開始回答您的問題。

Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found on the Investor Relations tab on the company website, www.eyepointpharma.com. 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 may have made or may make with the SEC in the future.

今天早些時候，我們發布了一份新聞稿，詳細介紹了我們的財務表現和最近的公司發展。本新聞稿副本可在本公司網站 www.eyepointpharma.com 的「投資者關係」標籤頁中找到。在我們開始正式評論之前，我謹提醒您，我們今天發表的各種言論均構成《1995 年私人證券訴訟改革法》安全港條款所指的前瞻性陳述。這些包括關於我們未來預期、臨床發展、監管事項和時間表、我們的產品和產品候選物的潛在成功、財務預測以及我們的計劃和前景的聲明。由於各種重要因素，實際結果可能與這些前瞻性陳述所示的結果有重大差異，包括我們向美國證券交易委員會提交的最新 10-K 表年度報告中「風險因素」部分中討論的因素，以及我們可能已經提交或將來可能向美國證券交易委員會提交的其他文件中討論的因素。

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.

任何前瞻性陳述僅代表我們截至今天的觀點。雖然我們可能選擇在未來某個時間點更新這些前瞻性陳述，但我們明確表示不承擔任何義務，即使我們的觀點改變。因此，您不應依賴這些前瞻性陳述來代表我們今天之後任何日期的觀點。

I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of EyePoint.

現在我將電話轉給 EyePoint 總裁兼執行長 Jay Duker 博士。

Thank you, George. Good morning, everyone, and thank you for joining us. I am delighted to discuss with you today our key second quarter updates highlighted by the impressive progress of our Phase 3 clinical program for our lead asset, DURAVYU, in wet age-related macular degeneration or wet-AMD. Since January 2021, when the first patient was dosed with DURAVYU in our Phase 1 DAVIO trial, our diligent focus and exceptional execution across all fronts has brought us in just over 4.5 years to full enrollment in both of our Phase 3 pivotal trials in wet-AMD, a testament to EyePoint's leadership in drug development and commitment to serving the retinal community. Before discussing the specifics of the past quarter, I'd like to reflect on how far we've come as a company over the short period.

謝謝你，喬治。大家早安，感謝大家的收看。今天我很高興與大家討論我們第二季度的關鍵更新，重點是我們的主要資產 DURAVYU 在治療濕性年齡相關性黃斑部病變或濕性 AMD 的 3 期臨床計劃中取得了令人矚目的進展。自 2021 年 1 月在我們的 I 期 DAVIO 試驗中為第一位患者使用 DURAVYU 以來，我們勤奮專注且在各個方面表現出色，使我們在短短 4.5 年多的時間內就完成了兩項濕性 AMD I 期關鍵試驗的完全入組，這證明了 EyePoint 在藥物開發方面的領導地位以及服務視網膜社區的承諾。在討論上個季度的具體情況之前，我想回顧一下我們公司在短時間內取得了多大的進步。

We successfully and efficiently pivoted to a clinical stage biopharmaceutical company, prioritizing the development of DURAVYU as a new treatment paradigm in the two largest retinal disease markets, wet-AMD and diabetic macular edema, or DME, while exiting the specialty pharma business. We completed four clinical trials for DURAVYU, including three Phase 2 trials, treating over 190 patients with DURAVYU across multiple retinal indications, establishing a robust and favorable safety profile that is cited by physicians as a key motivator for their eager participation in our pivotal program. We've generated the most comprehensive data set among current sustained release therapies in development for wet-AMD, establishing truly compelling Phase 2 efficacy data, demonstrating statistically non-inferior visual acuity compared to on-label aflibercept, while reducing treatment burden by over 80%. Bolstered by this robust efficacy profile, outstanding safety and a patient-centric pivotal trial design, we completed oversubscribed Phase 3 enrollment in record time for this indication, with over 800 patients enrolled across the LUGANO and LUCIA trials. Thanks to rapid enrollment and efficient trial design, we are well positioned for top line LUGANO data in mid-2026 with LUCIA top line data anticipated shortly thereafter, a timeline that we believe positions us to be first to file, and potentially first to market among the current investigational sustained release therapies for wet-AMD.

我們成功且有效率地轉型為臨床階段的生物製藥公司，優先開發 DURAVYU 作為兩大視網膜疾病市場——濕性 AMD 和糖尿病性黃斑水腫 (DME) 的新治療範例，同時退出專科製藥業務。我們完成了 DURAVYU 的四項臨床試驗，其中包括三項 2 期試驗，用 DURAVYU 治療了超過 190 名患有多種視網膜疾病的患者，建立了強大而良好的安全性，醫生們認為這是他們熱切參與我們關鍵項目的主要動力。我們產生了目前正在開發的針對濕性 AMD 的緩釋療法中最全面的數據集，建立了真正令人信服的 2 期療效數據，證明了與標籤上的阿柏西普相比，其視力在統計上不遜色，同時將治療負擔減少了 80% 以上。憑藉其強大的療效、卓越的安全性和以患者為中心的關鍵試驗設計，我們以創紀錄的時間完成了該適應症的超額認購的 3 期患者招募，超過 800 名患者參加了 LUGANO 和 LUCIA 試驗。由於快速的招募和高效的試驗設計，我們已準備好在 2026 年中期獲得 LUGANO 頂線數據，並預計隨後不久獲得 LUCIA 頂線數據，我們相信這個時間表使我們成為第一個提交申請並可能在當前針對濕性 AMD 的研究性緩釋療法中率先上市的療法。

We also expanded the database underpinning DURAVYU's differentiated clinical profile beyond wet-AMD, reporting highly positive results in the Phase 2 VERONA trial in DME, supporting a pivotal program in this second blockbuster indication. In anticipation of potential commercial success, we built a state-of-the-art 41,000 square foot cGMP manufacturing facility in Northbridge, Massachusetts to support commercial production of DURAVYU, with registration batches currently underway to support an anticipated NDA filing and eventual pre-approval inspection. Finally, we transformed our balance sheet by eliminating debt and extending our cash runway into 2027, well beyond pivotal wet-AMD data in 2026. I'm incredibly proud of the pace and quality of these achievements, and we have no intention of taking our foot off the gas. Now for a closer look at wet-AMD.

我們還擴展了支持 DURAVYU 差異化臨床特徵的資料庫，使其不再局限於濕性AMD，並在 DME 的 2 期 VERONA 試驗中報告了非常積極的結果，為這一第二個重磅藥物適應症的關鍵項目提供了支持。為了實現潛在的商業成功，我們在馬薩諸塞州諾斯布里奇建造了一座佔地 41,000 平方英尺的最先進的 cGMP 製造工廠，以支持 DURAVYU 的商業化生產，目前正在進行註冊批次，以支持預期的 NDA 申請和最終的批准前檢查。最後，我們透過消除債務並將現金流延長至 2027 年，從而改變了我們的資產負債表，遠遠超過了 2026 年關鍵的濕 AMD 數據。我對這些成就的速度和品質感到無比自豪，我們不會放鬆腳步。現在來仔細看看濕性AMD。

This is a $10 billion market and growing in the United States, currently dominated by a single treatment modality, monotherapy with anti-VEGF biologics. While efficacious, patients with wet-AMD still tend to lose vision in the long term. Newer options intended to provide up to four months of visual stabilization in some patients still have similar limitations and often require significantly more frequent injections to maintain stable vision. In light of these drawbacks, improved durability remains the most important factor for physicians when choosing a wet-AMD therapy and represents an area of much needed innovation. Our lead product candidate, DURAVYU, presents a compelling treatment paradigm shift paired with a new mechanism of action to meet this need.

這是一個價值 100 億美元的市場，在美國不斷成長，目前主要以單一治療方式為主，即抗 VEGF 生物製劑單一療法。儘管有效，但患有濕性 AMD 的患者長期來看仍然容易喪失視力。較新的選擇旨在為某些患者提供長達四個月的視力穩定，但仍具有類似的局限性，並且通常需要更頻繁的注射才能維持穩定的視力。鑑於這些缺點，提高耐用性仍然是醫生選擇濕性AMD療法時最重要的因素，並且代表著急需創新的領域。我們的主要候選產品 DURAVYU 代表著一種引人注目的治療模式轉變，並結合了新的作用機制來滿足這一需求。

Backed by durable efficacy of at least six months, and a consistent and favorable safety profile, coupled with unique storage and administration advantages, we believe DURAVYU offers a differentiated product profile that is meaningful to physicians and patients and if approved, would facilitate strong competitive positioning in the wet-AMD treatment landscape. Let me now walk through the key attributes underpinning DURAVYU's differentiation. First, DURAVYU is not another anti-VEGF biologic or ligand blocking therapeutic, like the approved products on the market. It's a clinically validated sustained-release tyrosine kinase inhibitor, or TKI, that brings a new mechanism of action that may complement existing anti-VEGF biologics to offer more durable disease control and a reduced treatment burden. DURAVYU is comprised of the potent and selective TKI vorolanib, which works intracellularly to inhibit all VEGF receptors as well as the PDGF receptor, formulated in our bioerodible Durasert E technology.

我們相信，憑藉至少六個月的持久療效、一致且良好的安全性，以及獨特的儲存和管理優勢，DURAVYU 能夠提供差異化的產品特性，對醫生和患者都具有重要意義，一旦獲得批准，將有助於其在濕性 AMD 治療領域佔據強大的競爭地位。現在讓我來介紹一下 DURAVYU 差異化的關鍵屬性。首先，DURAVYU 不是另一種抗 VEGF 生物製劑或配體阻斷療法，就像市場上批准的產品一樣。它是一種經過臨床驗證的緩釋酪胺酸激酶抑制劑（TKI），它帶來了一種新的作用機制，可以補充現有的抗 VEGF 生物製劑，提供更持久的疾病控制並減輕治療負擔。DURAVYU 由強效且選擇性的 TKI 伏羅拉尼布組成，它在細胞內起作用，抑制所有 VEGF 受體以及 PDGF 受體，採用我們的生物可蝕性 Durasert E 技術配製而成。

Durasert E is a next-generation bioerodible sustained release insert, with a matrix designed to prevent free floating drug particles that contains no PEG and no PLGA. Second, unlike other sustained delivery therapies in development, DURAVYU is shipped and stored at ambient temperature. Consistent with current practice, DURAVYU is administered in the physician's office, with a standard intravitreal injection and comes in a preloaded sterile syringe injector. Most importantly, through its novel mechanism of action, DURAVYU can potentially deliver stable vision and retinal anatomy when dosed every six months, a cadence that should support improved compliance over the long term for wet-AMD patients. The clinical data generated to date indicates that DURAVYU has the potential to meaningfully change the wet-AMD treatment paradigm, and we've designed our Phase III program to validate this through a clinically rigorous but derisked approach.

Durasert E 是下一代可生物蝕解的緩釋插入物，其基質旨在防止不含 PEG 和 PLGA 的自由漂浮藥物顆粒。其次，與其他正在開發的緩釋療法不同，DURAVYU 在環境溫度下運輸和儲存。與現行做法一致，DURAVYU 是在醫生辦公室內進行給藥的，採用標準玻璃體內注射，並裝在預先安裝的無菌注射器中。最重要的是，透過其新穎的作用機制，DURAVYU 每六個月服用一次即可提供穩定的視力和視網膜解剖結構，這種節奏應有助於提高濕性 AMD 患者的長期依從性。迄今為止產生的臨床數據表明，DURAVYU 有可能顯著改變濕性 AMD 治療模式，並且我們已經設計了 III 期計劃，透過臨床嚴格但低風險的方法來驗證這一點。

Our Phase 3 LUGANO and LUCIA trials are double-masked, noninferiority trials designed in close alignment with the FDA, including written agreement from the agency to support a clear approval pathway and a compelling label. In addition, the patient-centric design of the trials allows all patients to receive treatment with the goal of maintaining or improving vision. The trials leverage an established design to measure noninferiority against on-label 2-milligram aflibercept. The use of on-label standard of care as the control is a key component of FDA guidance and critical to the noninferior design of the trials. Importantly, retinal specialists are familiar with leveraging non-inferiority trial data to inform their prescribing decisions as the last 4 wet-AMD approvals in the United States followed this approach.

我們的 3 期 LUGANO 和 LUCIA 試驗是雙盲非劣效性試驗，其設計與 FDA 密切相關，並獲得了該機構的書面協議，以支持明確的批准途徑和引人注目的標籤。此外，以患者為中心的試驗設計使所有患者都能接受以維持或改善視力為目標的治療。本試驗利用既定的設計來測量與標籤上標註的 2 毫克阿柏西普的非劣效性。使用標籤上的護理標準作為對照是 FDA 指南的關鍵組成部分，對於試驗的非劣效設計至關重要。重要的是，視網膜專家熟悉利用非劣效性試驗數據來指導他們的處方決策，因為美國最近 4 項濕性 AMD 批准都採用了這種方法。

Furthermore, the inclusion of both treatment-naive and previously treated patients enhances the applicability of our data and can enable a potentially broader label that would help drive increased physician adoption. If approved, our label is expected to have a differentiated six-month dosing interval -- this would be a significant improvement compared to current anti-VEGF treatments in the United States, which are dosed on average every two months. Driven by the clear market need for more durable wet-AMD therapy, DURAVYU's patient-centric trial design, robust and compelling Phase 2 clinical data package, and a record of excellent safety across the full clinical development program, we enrolled and randomized over 800 patients in LUGANO and LUCIA trials. LUCIA also marks our global expansion with sites in South America, Europe, Israel, Australia and India, demonstrating continued momentum and demand across the global wet-AMD patient community for DURAVYU. We are proud of the clinical rigor of our Phase 3 program, underscored by the fact that both the FDA and the EMA, the two largest regulatory agencies in the world have signed off on the protocol, and we have exceeded our enrollment time lines with no major changes to our trial design.

此外，納入初治患者和先前接受過治療的患者增強了我們數據的適用性，並且可以實現更廣泛的標籤，有助於推動醫生的採用。如果獲得批准，我們的標籤預計將具有差異化的六個月給藥間隔——與美國目前平均每兩個月給藥一次的抗 VEGF 治療相比，這將是一個顯著的改善。在市場對更持久的濕性AMD療法的明確需求、DURAVYU以患者為中心的試驗設計、強大而引人注目的2期臨床數據包、以及整個臨床開發計劃的出色安全記錄的推動下，我們在LUGANO和LUCIA試驗中招募並隨機分配了800多名患者。LUCIA 也標誌著我們的全球擴張，目前已在南美洲、歐洲、以色列、澳洲和印度開設了分支機構，表明 DURAVYU 在全球濕性 AMD 患者群體中持續保持強勁發展勢頭並廣受歡迎。我們為我們的 3 期臨床試驗計劃的臨床嚴謹性感到自豪，全球最大的兩個監管機構 FDA 和 EMA 均已簽署該方案，而且我們已經超出了入組時間表，而我們的試驗設計沒有發生重大變化。

With the 56-week primary endpoint for both trials, we anticipate LUGANO top line data in mid-2026 with LUCIA to closely follow, giving us confidence in our first-to-file and first-to-market position among current investigational sustained release therapies. The consistently positive feedback from physicians and patients continues to strengthen our conviction in DURYVU's differentiated profile and eventual commercial success. As part of the efforts to maintain first-mover advantage, we have made significant strides in our commercial readiness, while remaining disciplined in our investments. Our state-of-the-art cGMP commercial manufacturing facility in Northbridge, Massachusetts is designed to meet future commercial demand. In support of a potential NDA filing, DURAVYU registration batches are underway.

兩項試驗的主要終點均為 56 週，我們預計 LUGANO 頂線數據將於 2026 年中期公佈，LUCIA 也將緊隨其後，這讓我們對在當前研究性緩釋療法中的先申請和先上市地位充滿信心。醫生和患者的持續正面回饋繼續增強了我們對 DURYVU 差異化優勢和最終商業成功的信心。作為保持先發優勢的努力的一部分，我們在商業準備方面取得了重大進展，同時在投資方面保持紀律。我們位於馬薩諸塞州諾斯布里奇的最先進的 cGMP 商業製造工廠旨在滿足未來的商業需求。為了支持潛在的 NDA 申請，DURAVYU 註冊批次正在進行中。

Additionally, we thoughtfully added to our organization, expanding key areas, such as late-stage clinical development, regulatory, pharmacovigilance, biometrics and medical affairs, all while maintaining fiscal discipline. While our top priority is advancing our wet-AMD program through top line data and an NDA filing, we are also excited to report our continued progress in DME, the second largest retinal disease indication. Affecting approximately 25% of diabetic patients, DME is estimated to represent a $3 billion market opportunity by 2030 in the United States. Like wet-AMD, the significant burden of regular anti-VEGF injections often results in missed doses and lost vision, suggesting the need for more durable therapies. Following the compelling safety and efficacy results of our Phase 2 VERONA trial in DME earlier this year, we had a positive end of Phase II meeting with the FDA to align on a future pivotal program.

此外，我們也精心擴充了組織規模，擴大了後期臨床開發、監管、藥物警戒、生物辨識和醫療事務等關鍵領域，同時維持了財務紀律。雖然我們的首要任務是透過頂線數據和 NDA 申請推進我們的濕性 AMD 項目，但我們也很高興地報告我們在第二大視網膜疾病適應症 DME 方面繼續取得進展。DME 影響著約 25% 的糖尿病患者，預計到 2030 年將在美國帶來 30 億美元的市場機會。與濕性AMD一樣，定期注射抗VEGF藥物的負擔很重，常常會導致漏服和視力喪失，這表明需要更持久的治療方法。繼今年稍早我們在 DME 中進行的 2 期 VERONA 試驗取得了令人信服的安全性和有效性結果之後，我們與 FDA 進行了 2 期會議，並就未來的關鍵計劃達成了一致。

We look forward to sharing more details on our pivotal plan in the upcoming months. In summary, with top line Phase III data for both LUGANO and LUCIA on track for readout in 2026, and urgent and growing need for safe, effective and more durable treatment options for wet-AMD and DME, EyePoint is well positioned to continue as the leader in sustained release drug delivery for retinal disease as we partner with the retinal community to improve patients' lives while creating long-term value. Our decades of clinical experience, next-generation technology and blockbuster potential of the DURAVYU franchise highlights our exciting growth story. Before passing it over to George to review our financials, I want to thank the entire EyePoint team for their commitment to our goal of improving patients' lives through better vision, as well as the patients and the clinical investigators outside of our organization who are participating in our trials. We deeply appreciate your confidence in us, and we are proud to advance our therapeutics for the benefit of the entire retinal community.

我們期待在接下來的幾個月中分享有關我們關鍵計劃的更多細節。總而言之，由於 LUGANO 和 LUCIA 的 III 期頂線數據預計將在 2026 年公佈，而且對濕性 AMD 和 DME 的安全、有效和更持久治療方案的需求日益迫切，EyePoint 已做好準備，繼續作為視網膜疾病緩釋藥物輸送領域的領導者，與視網膜界合作，改善患者的生活，同時創造長期價值。我們數十年的臨床經驗、下一代技術以及 DURAVYU 特許經營的巨大潛力彰顯了我們令人興奮的成長故事。在交給喬治審查我們的財務狀況之前，我要感謝整個 EyePoint 團隊致力於透過更好的視力改善患者的生活，以及感謝參與我們試驗的組織外的患者和臨床研究人員。我們深深感謝您對我們的信任，我們很自豪能夠推進我們的治療方法，造福整個視網膜界。

We look forward to continued progress towards our upcoming milestones as we further our leadership in sustained ocular drug delivery. I will now turn the call back over to George. George?

我們期待在進一步鞏固我們在持續眼部給藥領域的領導地位的同時，繼續朝著即將到來的里程碑邁進。現在我將把電話轉回給喬治。喬治？

Thank you, Jay. To begin, we continue disciplined financial management and good stewardship of our cash, ending the second quarter with $256 million in cash and investments. Of note, as Jay just mentioned, the rapid enrollment of over 800 patients in the LUGANO and LUCIA trials accelerated our planned use of cash into the first half of 2025. The trial enrollment was well ahead of our expectations and the associated burn is included in our plan and cash runway guidance. Now that we have completed full enrollment for both trials, we expect cash burn to meaningfully decline in the second half of 2025.

謝謝你，傑伊。首先，我們繼續嚴格財務管理和妥善管理現金，第二季末我們的現金和投資總額為 2.56 億美元。值得注意的是，正如傑伊剛才提到的，LUGANO 和 LUCIA 試驗迅速招募了 800 多名患者，這加速了我們計劃在 2025 年上半年使用現金的速度。試驗報名人數遠遠超出了我們的預期，相關支出已包含在我們的計劃和現金流指導中。現在我們已經完成了這兩項試驗的全部招募，我們預計 2025 年下半年現金消耗將大幅下降。

Accordingly, we affirm previous cash runway guidance and expect cash will support our operations into 2027 well beyond key data readouts for our Phase 3 wet-AMD program in 2026. As the financial results for the three months ended June 30, 2025, were included in the press release issued this morning, my comments today will focus on a high-level review for the quarter. For the quarter ended June 30, 2025, total net revenue was $5.3 million compared to $9.5 million for the quarter ended June 30, 2024. Net revenue from license and royalties for the quarter ended June 30, 2025, totaled $5.3 million compared to $8.4 million in the corresponding period in 2024. The decrease was primarily driven by lower recognition of deferred revenue related to the agreement to licensed YUTIQ product rights completing our exit from Specialty Pharma.

因此，我們確認先前的現金流預測，並預計現金將支持我們到 2027 年的運營，遠遠超出 2026 年第三階段濕性 AMD 項目的關鍵數據讀數。由於今天早上發布的新聞稿中包含了截至 2025 年 6 月 30 日的三個月的財務業績，因此我今天的評論將集中於本季度的高層審查。截至 2025 年 6 月 30 日的季度，總淨收入為 530 萬美元，而截至 2024 年 6 月 30 日的季度為 950 萬美元。截至 2025 年 6 月 30 日的季度，授權和特許權使用費淨收入總計 530 萬美元，而 2024 年同期為 840 萬美元。下降的主要原因是，與 YUTIQ 產品權利授權協議相關的遞延收入確認減少，導致我們退出 Specialty Pharma。

Operating expenses for the quarter ended June 30, 2025, totaled $67.6 million, compared to $44 million in the prior year period. This increase was primarily driven by the increase in clinical trial costs related to the ongoing Phase 3 LUGANO and LUCIA clinical trials of DURAVYU for wet-AMD. Net nonoperating income totaled $2.9 million and net loss was $59.4 million, or $0.85 per share compared to a net loss of $30.8 million, or $0.58 per share for the prior year period. As I noted earlier, cash and cash equivalents and investments in marketable securities on June 30, 2025, totaled $256 million compared to $371 million as of December 31, 2024. And again, we affirm cash guidance unchanged into 2027.

截至 2025 年 6 月 30 日的季度營運費用總計 6,760 萬美元，而去年同期為 4,400 萬美元。這一增長主要是由於 DURAVYU 治療濕性 AMD 的正在進行的 3 期 LUGANO 和 LUCIA 臨床試驗相關的臨床試驗成本增加所致。淨非營業收入總計 290 萬美元，淨虧損為 5,940 萬美元，即每股 0.85 美元，而去年同期的淨虧損為 3,080 萬美元，即每股 0.58 美元。正如我之前提到的，2025 年 6 月 30 日的現金、現金等價物和有價證券投資總額為 2.56 億美元，而 2024 年 12 月 31 日為 3.71 億美元。我們再次確認，到 2027 年，現金指引將保持不變。

In conclusion, we're incredibly pleased with EyePoint's progress so far in 2025 and remain well capitalized to deliver DURAVYU Phase 3 data in 2026. I'll now turn the call back over to Jay for closing remarks.

總而言之，我們對 EyePoint 在 2025 年迄今的進展感到非常滿意，並且仍有足夠的資金在 2026 年提供 DURAVYU 第 3 階段數據。現在我將把電話轉回給傑伊，請他做最後發言。

Thank you, George. As you've heard this morning, we ended the second quarter in a phenomenal position, and we remain focused on advancing DURAVYU, a best-in-class program in wet-AMD. With our strong balance sheet and clear development strategy, we are prepared to execute through our upcoming key milestones, including top line data for the Phase 3 LUGANO trial anticipated in mid-2026, with LUCIA to closely follow. An NDA submission for DURAVYU in wet-AMD, assuming positive data and continued updates on the DME program, including a presentation of the Phase 2 VERONA end-of-study results at the Retina Society Annual Meeting in September. Our 2025 progress to date reflects our dedication to advancing our pipeline and delivering innovative treatments for serious retinal diseases, and we are excited to continue our momentum throughout the second half of the year.

謝謝你，喬治。正如您今天早上所聽到的，我們在第二季度結束時取得了非凡的成績，並且我們仍然專注於推進 DURAVYU，這是濕性 AMD 領域的一流項目。憑藉強大的資產負債表和清晰的發展策略，我們準備好實現即將到來的關鍵里程碑，包括預計於 2026 年中期進行的第三階段 LUGANO 試驗的頂線數據，LUCIA 將緊隨其後。提交 DURAVYU 治療濕性 AMD 的 NDA，假設獲得積極數據並持續更新 DME 計劃，包括在 9 月份視網膜學會年會上展示第 2 階段 VERONA 研究結束結果。我們在 2025 年迄今的進展反映了我們致力於推進產品線和為嚴重視網膜疾病提供創新治療方法的努力，我們很高興能夠在下半年繼續保持這一勢頭。

Thank you all very much for your attention this morning. I will now turn the call over to the operator for your questions.

非常感謝大家今天早上的關注。現在我將把電話轉給接線員來回答您的問題。

(Operator Instructions)

（操作員指示）

Tess Romero, JPMorgan.

摩根大通的泰絲·羅梅羅。

So maybe you could speak a little bit to overall trial conduct of these two pivotal studies in wet-AMD and what you're really focused on getting right to mitigate any key risks.

因此，也許您可以稍微談談這兩項濕性 AMD 關鍵研究的整體試驗情況，以及您真正關注的如何正確減輕任何關鍵風險。

Thanks for the question, Tess. Nice to hear from you. That's really a question I think Ramiro, our Chief Medical Officer, can answer best because this is obviously what he is now focusing on and will be focusing on over the next year, given that we are now fully enrolled. So Ramiro, do you want to take that question?

謝謝你的提問，苔絲。很高興收到你的來信。我認為我們的首席醫療官拉米羅最能回答這個問題，因為這顯然是他現在關注的重點，而且考慮到我們現在已經完全入學，他明年還會繼續關注這個問題。那麼拉米羅，你想回答這個問題嗎？

Yes. Thanks for the question, Tess. And I think one advantage that EyePoint has is that, we have a strong large Phase 3 study that gave us a lot of experience on the conduct of studies with our 1901 DURAVYU. So as Jay mentioned, we executed really well on the enrollment, completed the enrollment for both studies ahead of time. And now the focus is on the study conduct.

是的。謝謝你的提問，苔絲。我認為 EyePoint 的一個優點是，我們擁有強大的大型 3 期研究，這使我們在使用 1901 DURAVYU 進行研究方面積累了豐富的經驗。正如傑伊所提到的，我們的招生工作做得非常好，提前完成了兩個研究的招生。現在的重點是研究的進行。

So of course, we are -- have a collaboration very closely with the clinical sites, with the investigators to get and make sure that there is no deviations on this protocol. We also, of course, track safety of our patients in the study, which is very important. We have a good collaboration with our CRO that help us conduct the study. So now it's all about making sure that we have a great execution over the next 12 months, and then study preparation for our top line results with on-time database lock and other activities that are necessary for the top line results.

因此，當然，我們與臨床站點、研究人員密切合作，以確保該協議沒有偏差。當然，我們也會在研究中追蹤患者的安全，這非常重要。我們與 CRO 保持著良好的合作，這有助於我們進行研究。因此，現在我們要確保在未來 12 個月內我們能有出色的執行力，然後透過按時鎖定資料庫和其他對營收結果至關重要的活動來研究如何為營收結果做好準備。

And maybe if I could add just a little bit more about our protocol. Once again, this noninferiority trial design is something that retinal physicians are really used to. Our control group is on label. And the study design, again, is simple for the sites and the patients to understand. So, I think all of this helps keep patients in the trial.

也許我可以再補充一點有關我們協議的內容。再次強調，這種非劣效性試驗設計是視網膜醫師真正習慣的。我們的對照組是依照標籤分類的。而且，研究設計簡單，方便研究中心和病人理解。所以，我認為所有這些都有助於讓患者繼續參加試驗。

And our dropout rate is quite low in both trials, less than 2% currently. So, from that regard, we're doing really, really well also.

兩次試驗中的退出率都很低，目前不到 2%。所以，從這個方面來看，我們也做得非常非常好。

Jennifer Kim, Cantor Fitzgerald.

珍妮佛金 (Jennifer Kim)，費茲傑羅領唱。

Congrats on the continued execution, the delivery and consistency of these trials has been refreshing to see. Maybe to start off, I know you said you've talked about not disclosing certain mask data in the Phase 3s and avoiding introducing operational bias. Is there a line that would concern regulators in terms of introducing bias? And are you able to say anything on the cadence of, say, supplemental rescues as far as whether they've stayed within expectations? Maybe we can start there.

祝賀這些試驗的持續執行，其成果和一致性令人耳目一新。首先，我知道您說過您曾討論過在第三階段不披露某些口罩數據並避免引入操作偏見。在引入偏見方面，是否存在令監管機構擔憂的界限？能否談談補充救援的節奏是否符合預期？也許我們可以從那裡開始。

Yes. Good question, Jennifer. Thanks for that. So I think at a high level, talking about masked demographics such as age, sex, OCT visual acuity of the patients that have been enrolled is not really any risk. And we will likely do that in the future prior to top line data.

是的。問得好，珍妮佛。謝謝。因此我認為，從高層次上講，談論已入組患者的年齡、性別、OCT 視力等掩蓋人口統計數據實際上並沒有任何風險。我們很可能會在公佈頂線數據之前這樣做。

On the other hand, what we wouldn't want to do is introduce bias that would cause investigators or patients to alter their behavior. There really isn't any reason for us in my mind to put that risk into our trial results at this point. So, while we may, under circumstances in the future, rethink this, right now, things are going so well that we wouldn't want to introduce unnecessary risk into the studies. And once again, Ramiro, if you want to give a little more color on that or any more detail, please feel free.

另一方面，我們不想引入偏見，導致研究人員或患者改變他們的行為。我認為我們目前確實沒有任何理由將這種風險納入我們的試驗結果中。因此，雖然我們可能會在未來的情況下重新考慮這一點，但目前情況進展順利，我們不想在研究中引入不必要的風險。再說一次，拉米羅，如果你想對此進行更多的闡述或更多的細節，請隨意。

No, I think you covered well. And of course, we have a lot of the mechanics to make sure that the safety of the patients is going well, including an independent data monitoring committee that assess the safety of our study on an independent matter. And we issued that press release included that information that the safety of whichever brand is going as we expected as well as our Phase II study. But as Jay mentioned, we want to make sure we don't introduce unnecessary bias in the study that is going so well so far.

不，我認為你掩護得很好。當然，我們有許多機制來確保病患的安全，包括一個獨立的資料監測委員會，該委員會可以獨立評估我們研究的安全性。我們發布的新聞稿中包含了這樣的訊息：無論哪個品牌的安全性都符合我們的預期，而我們的第二階段研究也符合預期。但正如傑伊所提到的，我們希望確保我們不會在目前進展順利的研究中引入不必要的偏見。

Okay. That's helpful. And my second question is actually related to that. Should we expect a regular cadence of safety updates like on a quarterly or some periodic basis?

好的。這很有幫助。我的第二個問題實際上與此有關。我們是否應該期待每季或某個週期定期進行安全更新？

Well, I think we will give periodic updates. We haven't really discussed internally, will there be a cadence. We'll cover that in the future. And yes, I think it's quite likely that we will give periodic updates to the safety database as we hear from the Data Safety Monitoring Committee.

嗯，我想我們會定期更新。我們還沒有真正在內部討論過是否會有一個節奏。我們將在以後討論這個問題。是的，我認為我們很可能會根據資料安全監測委員會的意見定期更新安全資料庫。

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

Congratulations on the tremendous enrollment for both LUGANO and LUCIA. Can you just elaborate on the rescue criteria for the trials, especially given the recent competitive updates and how that aligns with what is seen in the real world?

恭喜盧加諾 (LUGANO) 和盧西亞 (LUCIA) 的招生人數大幅增加。您能否詳細說明試驗的救援標準，特別是考慮到最近的競爭更新以及它與現實世界中看到的情況如何一致？

Thanks for the question, Tyler. I'll actually address the second part of your question first. And again, if you talk to retina specialists and you ask them about the supplemental criteria in any one study, their first reaction is, well, that's not what I do in the real world. And the issue is that in the real world, giving an additional injection is something that is very much individualized to the patient. What's their vision?

謝謝你的提問，泰勒。我實際上首先要回答你問題的第二部分。再說一次，如果你與視網膜專家交談並詢問他們任何一項研究中的補充標準，他們的第一個反應是，這不是我在現實世界中所做的事情。問題在於，在現實世界中，額外注射是針對患者個別情況而定的。他們的願景是什麼？

How is the other eye doing? Do they notice a change? A myriad of things that individualize treatment for patients. But for a study, you can't do that. You need to have strict guidelines, especially in a pivotal program about when a rescue or supplement injection is given.

另一隻眼睛怎麼樣了？他們注意到變化了嗎？為患者提供個人化治療的無數方法。但對於一項研究來說，你不能這麼做。您需要有嚴格的指導方針，特別是在何時進行救援或補充注射的關鍵計劃中。

So, as we have disclosed publicly in the past, our Phase 3 supplement criteria, we think, is very straightforward. If a patient loses more than 5 letters with 75 microns of new fluid over best on study due to wet-AMD, they should be rescued. And that's been consistent from the start of the trial, we haven't amended that. In addition, we have a second criteria, which is new site-threatening hemorrhage that is caused by wet age-related macular degeneration. And we've set up a system that's working, we think, quite well with injection monitors, and we've asked the sites to call one of these monitors, and they've been excellent about getting on the line with the sites right away to discuss potential rescue over a hemorrhage.

因此，正如我們過去公開披露的那樣，我們認為我們的第三階段補充標準非常簡單。如果患者因濕性 AMD 而失去超過 5 個字母，且新液體比研究最佳值高出 75 微米，則應進行搶救。從審判開始我們就一直堅持這一點，我們沒有修改過。此外，我們還有第二個標準，即由濕性老年黃斑部病變引起的威脅新部位的出血。我們已經建立了一個運作良好的系統，其中配備了注射監測器，並且我們已經要求各個站點呼叫其中一名監測器，他們能夠立即與站點通電話，討論出血的潛在救援措施，表現非常出色。

And that needs to include a fundus photograph. And the reason we did that was when we looked at our Phase 2 data, in the DAVIO 2 wet-AMD trial, there were nine patients who were rescued in all three groups total for hemorrhage. Well, when we looked at the fundus photographs and the clinical situation with our KOLs and our advisers, six out of nine of those eyes either didn't have a hemorrhage or the hemorrhage was not due to wet-AMD, or was not site threatening. So, we really want to only rescue the patients who need it and are going to benefit from it and not rescue patients who do not. And therefore, again, this was Dr.

這需要包括眼底照片。我們這樣做的原因是，當我們查看 DAVIO 2 濕性 AMD 試驗中的第 2 階段數據時，發現三組中共有 9 名患者因出血而得到搶救。好吧，當我們與我們的 KOL 和顧問一起查看眼底照片和臨床情況時，其中九隻眼睛中有六隻沒有出血，或者出血不是由濕性 AMD 引起的，或者對部位沒有威脅。因此，我們真正想拯救的是那些需要幫助並且會從中受益的病人，而不是那些不需要幫助的病人。因此，再說一次，這是博士。

Ribeiro's evaluation of the rescues in the Phase 2. We don't have a criteria for fluid alone. We don't have a criteria for visual acuity loss alone, because in those situations, what we saw in the Phase 2 is a rescue injection didn't help. And in the Phase 2, 20% of the rescues were not per any of the protocol rescue requirements. They were due to the physician discretion.

裡貝羅對第二階段救援的評估。我們沒有單獨針對流體的標準。我們沒有單獨針對視力喪失的標準，因為在這些情況下，我們在第二階段看到的是救援注射沒有幫助。而在第二階段，20%的救援並不符合任何救援協議的要求。這是由醫生自行判斷的。

And we've removed physician discretion in the Phase 3.

我們已經在第三階段取消了醫生的自由裁量權。

Our next question comes from Yigal Nochomovitz. Yigal?

下一個問題來自 Yigal Nochomovitz。伊加爾？

Our next question comes from Yatin Suneja from Guggenheim.

下一個問題來自古根漢美術館的 Yatin Suneja。

Maybe two quick ones for me. With regard to the baseline, could you just comment on what percentage of naive and exposed patients you are targeting and where did you end up? If you can just talk about that on a high level. And then switching to the commercial dynamic, could you just talk about your early commercialization strategy, what work you might be doing now? What type of patients can we address?

對我來說也許有兩個快速的方法。關於基線，您能否評論一下您所針對的初始患者和暴露患者的比例是多少，以及最終結果如何？如果你能從高層次談論這個問題。然後轉到商業動態，您能談談您早期的商業化策略嗎，您現在可能在做什麼工作？我們可以治療哪些類型的患者？

And how should we think about the overall commercial team.

以及我們應該如何看待整個商業團隊。

Thanks, Yatin. Nice to hear from you. First of all, with the baseline division between patients who were previously treated and who were naive to treatment, we sought to get about a 75%, 25% naive to previously treated ratio, and that's in fact, what we achieved. So, 75% of the enrolled eyes were naive. With respect to commercialization, we've had an early product commercialization team on this essentially since the beginning of our Phase 2 DAVIO 2 wet AMD trial.

謝謝，亞汀。很高興收到你的來信。首先，在對先前接受過治療的患者和未接受過治療的患者進行基線劃分時，我們力求獲得大約 75% 的未接受過治療和 25% 的既往接受過治療患者的比例，事實上，我們也實現了這一目標。因此，75% 的登記眼睛都是未成熟的。關於商業化，基本上從我們的第二階段 DAVIO 2 濕性 AMD 試驗開始以來，我們就有一個早期產品商業化團隊。

And they have been working diligently, not only in, let's say, preparing the market, which I think they've done a very good job in raising physician awareness of what a TKI is and how it's differentiated from our current therapies, as well as how a sustained release delivery system like Durasert E can be advantageous for small molecule delivery. But they've also been in discussions with payers and with administrators of both large and small retinal practices in the United States and out of the United States to get a feel for how we can set the stage for us to be successful in the marketplace. So, this has been an extensive broad and deep effort that we've done and we'll continue to do. And we are planned and budgeted to start to build our commercial team in more breadth and depth later this year in anticipation of a successful NDA and potential launch, we hope at the end of 2027.

他們一直在勤奮工作，不僅僅是在準備市場，我認為他們在提高醫生對 TKI 是什麼以及它與我們現有療法的區別的認識方面做得非常好，以及像 Durasert E 這樣的緩釋輸送系統如何有利於小分子輸送。但他們也一直在與美國國內和國外的大型和小型視網膜診所的付款人和管理人員進行討論，以了解我們如何為在市場上取得成功奠定基礎。因此，我們已經做出了廣泛而深入的努力，並將繼續這樣做。我們計劃併預算在今年稍後開始更廣泛、更深入地建立我們的商業團隊，以期成功簽署保密協議並可能在 2027 年底推出。

Maybe one more, if I can follow up. Just on the naive versus exposed patient, are there special consideration for how we should think about the rescue rate or the injection fee rate, at least on the control arm for these naive versus the exposed patients? Just curious how that dynamic will be between these two subsets.

如果我可以跟進的話，也許還會再來一次。僅針對初治患者和暴露患者，我們是否應該特別考慮如何考慮救援率或註射費率，至少在這些初治患者和暴露患者的對照組中？只是好奇這兩個子集之間的動態如何。

That's a good question, Yatin. And I don't think we can actually know that yet. we expect that the rescue rate for naive patients will be less than what we saw in the DAVIO 2 Phase 2 trial. The reasoning is in the DAVIO 2 trial, while they were all previously treated patients, the vast majority of them were being treated often, as we like to refer to them as frequent flyers. On average, those patients had received 10 injections normalized of the year leading into the study.

這是個好問題，亞廷。我認為我們實際上還不能知道這一點。我們預計，初治患者的搶救率將低於我們在 DAVIO 2 第 2 階段試驗中看到的情況。理由是，在 DAVIO 2 試驗中，雖然他們都是以前接受過治療的患者，但絕大多數人經常接受治療，我們喜歡稱他們為常旅客。平均而言，這些患者在研究開始前的一年內接受了 10 次標準化注射。

And in the United States, we specialists average about 6 injections per year. So, this is a group of patients that needed a lot of treatment. Yet we did pretty well with them. We got very few patients who had already been treated and extended out three months or longer. They just didn't enroll in that trial.

而在美國，我們專家平均每年註射約6次。所以，這是一群需要大量治療的患者。但我們和他們相處得很好。在我們收到的已接受治療的患者中，只有極少數人的病程延長了三個月或更長時間。他們只是沒有參加那次試驗。

Now our assumption, and I think it should be clear to everybody that, if we have a patient who can be successfully treated and extended out to three months or longer on any of the current agents, our drug, DURAVYU should do really well with those patients. So, we wanted to get a portion of them into the trial. And depending on who you talk to, this could be 20% or 25% of the wet AMD naive population. So, we think that by enrolling a predominantly naive population, we should see fewer supplements, and we hope to see, therefore, better visual acuity results. I will like to remind everyone that, if you looked at the patients in DAVIO 2 that did not get supplemented, they made it through month 8 with no supplement, their visual acuities were numerically better than the Eylea control group.

現在我們的假設是，我想每個人都應該清楚，如果我們有一個病人，他可以透過任何一種現有的藥物成功治療，並將治療時間延長到三個月或更長時間，那麼我們的藥物 DURAVYU 應該對這些病人有很好的療效。因此，我們希望讓其中一部分人參與試驗。並且根據你與誰交談，這可能佔濕性 AMD 初診族群的 20% 或 25%。因此，我們認為，透過招募主要為未受過教育的人群，我們應該看到更少的補充劑，並且我們希望因此看到更好的視力結果。我想提醒大家的是，如果你觀察一下 DAVIO 2 中沒有服用補充劑的患者，他們在沒有服用補充劑的情況下度過了第 8 個月，他們的視力在數值上優於 Eylea 對照組。

So the unsupplemented patients seem to do exceptionally well with our drug, and we hope and expect that will continue in the pivotal trial.

因此，未接受補充治療的患者似乎對我們的藥物反應非常好，我們希望並期待這種情況能夠在關鍵試驗中繼續下去。

Yigal Nochomovitz, Citigroup.

花旗集團的 Yigal Nochomovitz。

I had two questions. One on the endpoint. There's been some chatter in the marketplace with respect to the blended versus the single time point. I'm just wondering, if you could comment, Jay, on that point. And is this a detail that the retina professionals really even care about whether you happen to average two very close points in time versus a single point in time?

我有兩個問題。一個在端點上。市場上存在一些關於混合與單一時間點的討論。我只是想知道，傑伊，你是否可以對這一點發表評論。視網膜專家真的會在乎這個細節嗎？您是否碰巧平均了兩個非常接近的時間點，而不是單一時間點？

And then also just looking ahead to the potential launch, assuming everything goes well with the studies, is this a situation where once you get to the label, you can just launch immediately? Or is it a situation where you would wait until you have the label language in hand and then there'd be a period of time where you have to do the final fill and finish label printing and so forth and then launch some period of time after actually the PDUFA?

然後展望潛在的發布，假設研究一切順利，是否一旦獲得標籤，就可以立即發布？或者情況是，您要等到手上有標籤語言，然後需要一段時間進行最後的填充和完成標籤打印等，然後在實際 PDUFA 之後的某個時間推出？

Great. Thanks, Yigal. Two good questions. So, the blended endpoint was a regulatory, let's call it, strong suggestion. In fact, in our 2022 Type C meeting on our pivotal program, they insisted on it.

偉大的。謝謝，伊加爾。兩個好問題。因此，混合終點是一種監管，我們稱之為強烈建議。事實上，在我們 2022 年關於關鍵項目的 C 類會議上，他們堅持這樣做。

And that's why we did a blended endpoint in our Phase II trial. This was reiterated again at our end of Phase II meeting in 2024 with the agency. And so, we obviously put that into our trial. We think the blended endpoint is a good thing. We think it decreases variability, and it decreases the risk of missing your primary endpoint.

這就是我們在第二階段試驗中採用混合終點的原因。我們在 2024 年與該機構舉行的第二階段會議結束時再次重申了這一點。因此，我們顯然將其納入了試驗之中。我們認為混合端點是件好事。我們認為它可以降低變異性，並降低錯過主要終點的風險。

This blended endpoint also will help ensure that there is no missing data at the end of the trial. Obviously, if a patient makes one of those two blended visits but misses the other, there's a way we statistically handle that versus if they miss the single endpoint entirely. So overall, the agency strongly suggested it, and we did it, and we're very happy that we did it. And we think this is another point of our protocol that is derisking. In addition, I have to add the blended endpoint has been used in most recent studies.

這種混合終點也將有助於確保試驗結束時沒有缺失資料。顯然，如果患者參加了兩次混合就診中的一次，但錯過了另一次，我們有辦法從統計上處理這個問題，而不是完全錯過單一終點。總的來說，該機構強烈建議我們這麼做，我們也這麼做了，我們很高興我們這麼做了。我們認為這是我們協議的另一個降低風險的要點。此外，我必須補充一點，最近的研究已經使用了混合端點。

This isn't new or unique. So, your second question about timing of launch. At this point, should our trials be successful and our NDA approved, we are working diligently towards an immediate launch after approval.

這並不是什麼新鮮事，也不獨特。那麼，您的第二個問題是關於發佈時間的。目前，如果我們的試驗成功並且我們的保密協議 (NDA) 獲得批准，我們將努力在獲得批准後立即推出產品。

Debanjana Chatterjee.

德班賈納·查特吉。

So with the first readout expected in mid-2026 and the second to follow shortly after, could you give us like any more color into your regulatory plans on how you'll gather the data and how soon you can submit? And maybe could you also comment on the scope of the safety package that the FDA would like to see with the initial filing?

因此，預計第一次讀數將在 2026 年中期發布，第二次讀數也將在隨後不久發布，您能否向我們詳細介紹一下您的監管計劃，包括您將如何收集數據以及多久可以提交？也許您也可以評論一下 FDA 希望在初始申請中看到的安全方案的範圍？

Sure. Thank you for that question. So now that we are fully enrolled in both studies in record time, Ramiro and his clinical group are really focused on ensuring that the data is sound, as we discussed earlier, and preparing for the NDA submission. So again, we expect top line data from the first trial to be summer of next year with the second trial, again, to follow shortly. I'm going to let Romero talk about some of the efforts around rapid NDA filing that we are working on.

當然。謝謝你的提問。因此，現在我們已經在創紀錄的時間內完全參與了這兩項研究，Ramiro 和他的臨床小組真正專注於確保數據的合理性（正如我們之前討論的那樣），並為 NDA 提交做準備。因此，我們再次預計第一次試驗的頂線數據將在明年夏天公佈，第二次試驗也將很快公佈。我將讓羅梅羅談談我們正在進行的有關快速提交保密協議 (NDA) 的一些努力。

Yes. Thanks for the question. As Jay mentioned before, our expertise and our strain is on the execution. So, the same way that we were able to execute rapidly on the enrollment, our aim is also to make sure that we do an NDA ahead of schedule. We have two identical non-inferiority studies.

是的。謝謝你的提問。正如傑伊之前提到的，我們的專業知識和壓力在於執行。因此，就像我們能夠快速完成註冊一樣，我們的目標也是確保提前完成保密協議。我們有兩項相同的非劣效性研究。

And this really gives the benefit of looking at the results from the first study from LUGANO doing some learnings there. And then when we get the results from LUCIA, be able to accelerate the interpretation and the write-up of those results, again, because both studies are identical. We should assume that the result of LUGANO is going to be replicated on LUCIA. In terms of the safety package, as any other NDA submission, this is going to include the results from our Phase 1, Phase 3 study as well as the combination of the Phase 3 program. And we should have enough patients to meet the requirements for the FDA for this type of indication.

這確實有利於我們了解盧加諾第一項研究的結果並在那裡進行一些學習。然後，當我們從 LUCIA 獲得結果時，能夠加快這些結果的解釋和記錄，因為這兩項研究是相同的。我們應該假設盧加諾的結果將會在盧西亞複製。就安全方案而言，與任何其他 NDA 提交一樣，這將包括我們的第 1 階段、第 3 階段研究以及第 3 階段計劃組合的結果。我們應該有足夠的患者來滿足 FDA 對此類適應症的要求。

And I just want to elaborate a little bit more on what Ramiro just said about numbers. So, the FDA has been clear for years about wet-AMD safety database. You need to have 300 evaluable patients at the dose and the interval that you want on your label. And if you come in with 299, it will not be accepted. That's why if you look at the draft guidelines, the draft guidelines say you need -- they recommend 400 patients enrolled in your trials at the dose and the interval you want to go to market with.

我只是想更詳細地闡述拉米羅剛才所說的數字。因此，FDA 多年來一直明確濕性 AMD 安全資料庫。您需要有 300 名可評估的患者，按照標籤上要求的劑量和間隔進行治療。如果你帶著 299 進來，就不會被接受。這就是為什麼如果你看一下指南草案，指南草案說你需要——他們建議 400 名患者按照你想要的劑量和間隔參加試驗。

That's to allow for attrition. So you come in with over 300. We will have well over 400 patients between both trials at the 6-month dosing at the 6-month interval at the 2.7-milligram dosing. So, we're very comfortable with the safety database that we will be coming in with. And I will also remind you, we can file after 1 year, 56 weeks, but both trials will be -- have a second year, which is a safety year only, and then we will file an sNDA for the extension after the second year.

這是為了考慮到人員減員。所以你拿到了 300 多個。在兩次試驗中，我們將以 6 個月的間隔、2.7 毫克的劑量接受超過 400 名患者的治療。因此，我們對即將採用的安全資料庫非常滿意。我還要提醒您，我們可以在 1 年 56 週後提交申請，但兩次試驗都將進行第二年，這僅僅是安全年，然後我們將在第二年後提交延期的 sNDA。

So go ahead, if you had another.

所以，如果你還有另一個，那就繼續吧。

Yes. Just a very quick one on filing. So, could you please remind us what could be the advantage of like filing the traditional way versus the 505(b)(2) pathway that some competitor trials like they are talking about that while the traditional one might be slightly longer, are there distinct advantages that you get there?

是的。關於歸檔，這只是一個非常快速的過程。那麼，您能否提醒我們，與一些競爭對手試驗的 505(b)(2) 途徑相比，以傳統方式提交申請有哪些優勢？他們正在談論的是，雖然傳統方式可能稍微長一些，但您是否獲得了明顯的優勢？

My understanding is that, if you are filing with a drug that's been approved already, there is a potential two-month savings over the traditional pathway. Now as you're aware, the FDA has talked publicly recently about accelerating the pathway in various ways, and we will obviously be looking at those for our filing. Regardless, if you have a moiety that's already been approved, but you're putting it now into a drug device combo. There's rules around what you need to file with for drug device combo. And we all have the same necessary clinical studies and CMC package that has to be delivered.

我的理解是，如果您提交的是已經核准的藥物，那麼與傳統途徑相比，可以節省兩個月的時間。如您所知，FDA 最近公開談論了以各種方式加速這一進程，我們顯然會在提交申請時考慮這些方式。無論如何，如果您擁有已經獲得批准的部分，但現在您要將其放入藥物設備組合中。有關於您需要提交藥物設備組合文件的規則。我們都有相同的必要臨床研究和 CMC 套件需要交付。

So, there's a short potential savings there. But again, we are quite confident in -- given the rapid rate of enrollment that we've had that we will be first to file and if the filing is accepted, first to approval and first to launch among all the currently studied sustained release in the marketplace or potential marketplace rather.

因此，存在短期節省的潛在風險。但是，我們非常有信心——鑑於我們的註冊速度很快，我們將是第一個提交申請的人，如果申請被接受，我們將是第一個獲得批准的人，也是第一個在市場上或潛在市場上目前研究的所有緩釋藥物中推出的人。

Lisa Walter, RBC.

麗莎·沃爾特（RBC）。

Maybe just on the pivotal trial progress. Should we expect any other updates beyond safety, like patient retention perhaps between now and when the pivotal trials begin to read out in mid-2026? And also, just curious if you are planning to run an open-label extension study for DURAVYU.

也許只是在關鍵的試驗上取得進展。除了安全性之外，我們是否還應該預期其他更新，例如從現在到 2026 年中期關鍵試驗開始結果之間的病患保留？另外，我只是好奇您是否計劃對 DURAVYU 進行開放標籤擴展研究。

Thanks for the questions. The second one is easy. Yes, we will do an extension study. We're in the midst of really planning that out, and we think that will provide tremendous value for practitioners and patients to understand the long-term benefits of DURAVYU. So that is in the planning As for pivotal trial progress, again, I do expect that we will give an update on the basic demographics of the enrolled patients.

感謝您的提問。第二個很簡單。是的，我們將進行延伸研究。我們正在認真規劃這一點，我們認為這將為醫生和患者了解 DURAVYU 的長期益處帶來巨大的價值。所以這是在計劃中至於關鍵試驗的進展，我再次希望我們能夠更新入組患者的基本人口統計。

We will likely give periodic safety updates as we receive the mass safety data. And that's what we have planned at the present time. Ramiro anything else you'd like to add about potential other masked interval additions?

當我們收到大量安全資料時，我們可能會定期提供安全性更新。這就是我們目前的計劃。Ramiro，您還有什麼關於其他潛在掩蔽間隔添加的內容想補充嗎？

No, I think you covered well. And also, we know the -- there always the potential risk of introducing bias, if you start disclosing too much in a Phase 3 study. So we are assessing that one.

不，我認為你掩護得很好。而且，我們知道——如果在第三階段研究中開始披露過多信息，總是存在引入偏見的潛在風險。所以我們正在評估這一點。

Colleen Kusy, Baird.

科琳·庫西，貝爾德。

Congrats on all the progress. If I can go back to the rescue criteria, can you talk about how the FDA views the rescue criteria and how they would handle the evaluation of the Phase 3 data for those patients that got rescued? And then separately on DME, any realized details are going to be forthcoming there, but any color you can share on the feedback from the FDA? And what are some of the factors you're still considering?

祝賀你取得的所有進展。如果我可以回到救援標準，您能否談談 FDA 如何看待救援標準以及他們將如何處理對獲救患者的第 3 階段數據的評估？然後單獨討論 DME，任何實現的細節都會在那裡公佈，但您可以分享 FDA 的反饋嗎？您還在考慮哪些因素？

Sure. So with respect to rescue criteria, the FDA, as far as I know, which only is limited to what we have been told and what we see publicly is they allow companies to apply their own standards for rescue criteria. And that's what we've done. Again, we were able to develop our rescue criteria based on real data. We did a large Phase 2 study, the DAVIO 2 trial, which not only informed us about efficacy of our drug, but safety as well as statistics and really gave us good data on what really should be done with respect to rescues.

當然。因此，關於救援標準，據我所知，FDA 僅限於我們所知道的和我們公開看到的內容，他們允許公司應用自己的救援標準。我們也確實這麼做了。再次，我們能夠根據真實數據制定救援標準。我們進行了一項大型的 2 期研究，即 DAVIO 2 試驗，它不僅讓我們了解了藥物的功效，還讓我們了解了藥物的安全性和統計數據，並為我們提供了有關救援方面真正應該做什麼的良好數據。

DME, we were very pleased with the discussions with the agency. We are excited to start the pivotal program. And by start, I mean, first patient enrolled in 2026. Technically, we've already started in the sense of preparing and manufacturing the inserts and obviously getting the clinical protocols ready. We're waiting for the written minutes.

DME，我們對與該機構的討論感到非常高興。我們很高興啟動這個關鍵項目。我所說的開始是指 2026 年招募第一位患者。從技術上講，我們已經開始準備和製造插入物，顯然也已經準備好了臨床方案。我們正在等待書面會議記錄。

And after the written minutes in the fall, we will update publicly on what our plans are. One of the things going back to supplements, though I might add, is that supplements are not viewed as a treatment failure in our trial. The supplement patients have sensitivity analysis that will be applied to them, and that's according to the statistics package that we've worked out with the FDA. And that's consistent with the real world. Because in the real world, if you had a patient who required anti-VEGF injections, say, every four weeks, and you gave them a DURAVYU, and we're safe, tolerated, effective, FDA approved with a six-month label, yet they required one or two supplements over a year, that would be a tremendous value to the patient and the practitioner to go from 12 shots a year to 4.

在秋季的書面會議紀錄發布後，我們將公開更新我們的計劃。不過，我想補充的是，關於補充劑的其中一件事是，在我們的試驗中，補充劑並不被視為治療失敗。我們將對服用補充劑的患者進行敏感性分析，這是根據我們與 FDA 共同製定的統計數據包進行的。這與現實世界一致。因為在現實世界中，如果您有一位患者需要每四周注射一次抗 VEGF 藥物，而您給他們注射了 DURAVYU，而且這種藥物是安全、耐受性良好、有效的，並且已獲得 FDA 批准，可使用六個月，但他們一年內仍需要服用一到兩次補充劑，那麼將每年註射 12 次減少到 4 次，對患者和醫生來說都將具有巨大的價值。

So, reflecting the fact that the idea of supplement because TKIs have a different MOA, supplementation in the real world is not necessarily a treatment failure. I think that's also reflected in how they will be handled in the pivotal trials.

因此，由於 TKI 具有不同的 MOA，因此補充的想法在現實世界中並不一定是治療失敗。我認為這也反映在他們在關鍵審判中將如何處理。

Graig Suvannavejh, Mizuho.

瑞穗的 Graig Suvannavejh。

This is Sam on for Greg. Congrats again on the quarter and all the progress. Maybe two quick ones for me. First, in terms of ASRS, just curious what the feedback has been from the physician community with their review. And then also for the upcoming presentation in September with the full end of study VERONA data, what incremental data should we be expecting compared to the top line?

這是 Sam 為 Greg 表演的。再次恭喜本季取得的所有進展。對我來說也許有兩個快速的方法。首先，就 ASRS 而言，我只是好奇醫生社群對他們的評論有何回饋。然後，對於即將於 9 月舉行的 VERONA 研究完整結束數據的演示，與頂線相比，我們應該期待哪些增量數據？

Thanks, Jim. We just got back from ASRS in Long Beach, and we had multiple meetings with advisory boards of various age groups and times in practice and a lot of one-on-one meetings. And I have to say, it was incredible. I mean, I was blushing. They were saying such positive things about our company and our program.

謝謝，吉姆。我們剛從長灘的 ASRS 回來，我們與不同年齡層和不同時間的顧問委員會進行了多次會議，並進行了許多一對一的會議。我必須說，這真是令人難以置信。我的意思是，我臉紅了。他們對我們的公司和我們的專案給予了高度評價。

They -- multiple investigators thanked us for allowing them to be in the program. And so it really was a kind of a nice segue from our announcement to full enrollment to the incredible positive feelings we had from all aspects of the retina community, not just about the execution of the trial and the ease of enrollment and the pleasure that they had being in it, but even the doctors who weren't in the trial, starting to understand that, first of all, we're the next ones up with pivotal data in wet-AMD in about a year. So, we are the next ones up for both studies in about a year. So, they're excited about that. They're excited about the potential of a new mechanism of action, not just another anti-VEGF that may give another week or two of extension, but a true extension possible for six months or longer with a new MOA.

他們—多名調查人員感謝我們允許他們參與該計劃。因此，從我們宣布全面招募到我們從視網膜社區各個方面獲得的令人難以置信的積極感受，這真的是一個很好的過渡，不僅僅是關於試驗的執行和招募的便利以及他們參與其中的樂趣，甚至那些沒有參加試驗的醫生也開始明白，首先，我們是下一個在大約一年後獲得濕性 AMD 關鍵數據的人。因此，我們將在大約一年後參與這兩項研究。所以，他們對此感到興奮。他們對新的作用機制的潛力感到興奮，這不僅僅是另一種可能延長一兩週的抗 VEGF 藥物，而是透過新的 MOA 真正實現六個月或更長時間的延長。

So yes, it was -- is a very, very productive, and I have to say, fun ASRS, and we really are looking forward, our entire team is looking forward to further interactions with the retina community and partnering with the retina community to really help their patients. As for what's coming in September, I'm going to defer to Ramiro for that update.

是的，這是一個非常非常有成效的會議，而且我必須說，它很有趣，我們真的很期待，我們的整個團隊都期待與視網膜社區進行進一步的互動，並與視網膜社區合作，真正幫助他們的患者。至於 9 月會發生什麼，我將聽從 Ramiro 的更新。

Yes, Sam, thanks for the question. I don't want to disclose so much because those presentations, retina society are important. But we're going to be building more on what we have presented before in terms of BCVA, CST and treatment burden for the VERONA trial.

是的，山姆，謝謝你的提問。我不想透露太多，因為這些演示、視網膜學會都很重要。但我們將在 VERONA 試驗中就 BCVA、CST 和治療負擔方面之前所提出的內容進行更多的建構。

Daniil Gataulin, Chardan.

丹尼爾·加陶林，Chardan。

Congrats on the progress. Just a couple of quick ones for me. With respect to LUCIA trial, what fraction of patients were US versus ex-US? And with that experience of enrolling ex-US patients, how would you describe the awareness and overall interest among patients in ex-US compared to here in the United States?

恭喜你取得進展。對我來說，只有幾個簡單的問題。就 LUCIA 試驗而言，美國患者和美國以外患者的比例是多少？並且根據招募美國境外患者的經驗，與美國境內患者相比，您如何描述美國境外患者的認知度和整體興趣？

So I don't have the exact final numbers for, but the last I saw, it was approximately 80% US, 20% ex-US. I think that reflects to a large degree, the fact that things went so fast in the United States that by the time we were able to get the ex-US sites up and running, we, in some cases, were near the end of the study or at the end of the study. But the interest in a sustained release, safe, effective six-month option ex-US is really, really great.

所以我沒有確切的最終數字，但我最新看到的數據是，大約 80% 來自美國，20% 來自美國以外。我認為這在很大程度上反映了這樣一個事實：美國的情況發展得太快了，當我們能夠讓美國以外的網站啟動並運行時，在某些情況下，研究已經接近尾聲或已經結束了。但人們對美國以外持續釋放、安全、有效的六個月選擇權的興趣確實非常大。

As you know, in some countries, getting long-term acute care, meaning monthly or bimonthly injections for a chronic problem is difficult. So both patients and practitioners were really excited about what DURAVYU might have to deliver should we be approved.

眾所周知，在某些國家，獲得長期急性照護（即每月或每兩個月注射一次治療慢性病）是困難的。因此，一旦獲得批准，患者和醫生都對 DURAVYU 可能帶來的好處感到非常興奮。

Yi Chen, H.C. Wainwright.

陳毅，H.C.溫賴特。

Could you please let us know whether there will be another Data Safety Monitoring committee meeting before the first data readout in mid-2026? And also, how should we look at the level of top line revenue in the coming quarters?

您能否告訴我們，在 2026 年中期首次讀取資料之前是否會再舉行一次資料安全監測委員會會議？此外，我們該如何看待未來幾季的營收水準？

The first question about the DSMB, Ramiro, do you want to answer that?

關於 DSMB 的第一個問題，Ramiro，您想回答嗎？

Yes. So as a typical Phase 3 program, we have a DMC meeting every six months. So, we expect to have at least two or more of those before the top line results.

是的。因此，作為典型的第 3 階段計劃，我們每六個月召開一次 DMC 會議。因此，我們預計在公佈最終結果之前至少會有兩項或更多的此類數據。

And the second question was about revenue? I'm sorry, you broke up a little bit.

第二個問題是關於收入嗎？對不起，你們分手了一點。

Yes. The level of top line revenue that you expect for the coming quarters?

是的。您預計未來幾季的營業收入水準是多少？

George, top line revenue.

喬治，營業收入。

Yes. So, you'll see in the Q -- our -- recall that we exited the commercial business two years ago, we had some follow-on revenue recognition really associated with that. It wasn't cash driven, and that was completed in Q2. And so moving forward, our revenue line will be de minimis. We still supply commercial product to our partner in China.

是的。因此，您會在 Q 中看到——我們——回想一下，我們兩年前退出了商業業務，我們有一些與此相關的後續收入確認。這不是現金驅動的，並且在第二季就完成了。因此，展望未來，我們的收入將會微乎其微。我們仍然向中國的合作夥伴供應商業產品。

But that -- we don't expect that to be a material number. We've really transitioned, as Jay said at the opening, to being a clinical stage company.

但是——我們並不認為這是一個實質的數字。正如傑伊在開幕式上所說，我們已經真正轉型為臨床階段公司。

Greg Harrison, Scotiabank.

加拿大豐業銀行的格雷格·哈里森。

This is Joe Thomas on for Greg. Just digging a little bit more maybe into the competitive landscape going forward and particularly the timing to market now that the competitor has announced that they won't read out their second trial until 2027. What advantage do you think that first-mover advantage in being first to market will give to DURAVYU wet AMD?

喬·托馬斯 (Joe Thomas) 代替格雷格 (Greg)。也許只需進一步深入了解未來的競爭格局，特別是上市時機，因為競爭對手已經宣布他們要到 2027 年才會宣讀第二次審判。您認為率先進入市場的先發優勢會為DURAVYU wet AMD帶來什麼優勢？

Joe, thanks for the question. Taking a step back, this is a huge market already. It's $10 billion in growing. And that if you look at drugs with a new MOA being launched into a new market, having two competitors actually is additive. So, we think having other companies interested in TKIs and sustained delivery is a good thing.

喬，謝謝你的提問。退一步來說，這已經是一個龐大的市場。其成長規模達 100 億美元。如果你看一下將具有新 MOA 的藥物推向新市場，那麼擁有兩個競爭對手實際上是一種附加效應。因此，我們認為其他公司對 TKI 和持續給藥感興趣是一件好事。

In saying that, the first-mover advantage is really important. And I think there's quite a bit of research around what the first mover advantage can be. But it's not just first mover. It's also ease of use and the label. We're confident that if we are approved, we will be approved with a label of every six months.

話雖如此，先發優勢確實很重要。我認為，關於先發優勢的研究已經相當多了。但它不僅僅是先行者。它也易於使用和標籤。我們相信，如果我們獲得批准，我們將每六個月獲得一次標籤批准。

And that flexibility to treat patients who may have recurred at seven months or eight months with fluid, again, at that point with your drug, I think, is going to be something that's going to be quite helpful to us. Our safety database from the Phase 2, very strong. Our safety continues in a mass fashion to match that. So, we also believe that we will come out compared to other potential competitors in the space with a probable safety advantage. So, it's not just the first mover.

而且，對於七、八個月後復發的患者，可以靈活地用液體治療，再者，在那個時候用藥物，我認為，這對我們來說非常有幫助。我們第二階段的安全資料庫非常強大。我們的安全措施將繼續大規模實施以適應這種情況。因此，我們也相信，與該領域的其他潛在競爭對手相比，我們將具有可能的安全優勢。所以，它不只是先行者。

I think there's a whole package of reasons why we are confident that we will be the leader in drug delivery sustained release in the retina should we be approved for many years.

我認為有很多理由讓我們有信心，如果我們獲得多年批准，我們將成為視網膜緩釋藥物傳遞領域的領導者。

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

我目前沒有其他問題。女士們、先生們，感謝大家參加今天的會議。這確實結束了你的計劃。您現在可以斷開連線。祝大家有個愉快的一天。