Vorolanib

– 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 – – $161.0 million oversubscribed equity financing extends cash runway into 2027 - 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 $10.5 million compared to $15.2 million for the quarter ended September 30, 2023. Net product revenue for the third quarter was $0.7 million, compared to net product revenues for the third quarter ended September 30, 2023, of $0.8 million. Net revenue from royalties and collaborations for the third quarter ended September 30, 2024, totaled $9.9 million compared to $14.4 million in the corresponding period in 2023. This decrease was primarily driven by lower recognition of deferred revenue related to the out-license of YUTIQ® product rights. Operating expenses for the third quarter ended September 30, 2024, totaled $43.3 million versus $29.6 million in the prior year period. This increase was primarily driven by (i) $5.4 million in costs related to the DURAVYU™ Phase 3 clinical trials for wet AMD, (ii) $3.8 million higher personnel expense for clinical and product development, including $2.1 million of non-cash stock compensation, (iii) $3 million in other R&D related expenses. Non-operating income, net, totaled $3.4 million and net loss was $29.4 million, or ($0.54) per share, compared to a net loss of $12.6 million, or ($0.33) per share, for the prior year period. Cash and investments at September 30, 2024 totaled $253.8 million compared to $331.1 million at December 31, 2023. Financial OutlookWe expect the cash, cash equivalents and investments on September 30, 2024, along with the net proceeds from the October $161.0 million equity financing will enable us to fund operations into 2027. 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 TartagliaPrecision AQ (formerly Stern IR)Direct: 212-698-8700christina.tartaglia@sternir.com Media Contact: Amy PhillipsGreen Room CommunicationsDirect: 412-327-9499aphillips@greenroompr.com EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIESCONDENSED 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 SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSUnaudited(In thousands, except per share data) Three Months EndedSeptember 30, Nine Months EndedSeptember 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

Insight 投融资数据库显示，上周全球制药领域发生 25 起投融资事件（截至 11 月 1 日）： 从药物类型来看，小分子之外，单抗，抗体偶联药物（ADC）、细胞和基因疗法（CGT）、放射性药物、反义寡核苷酸（ASO）等新分子也备受资本看好； 从地区分布来看，上周获得融资的 Biotech 仍然主要来自美国，占比达到约 48%； 在中国，华昊中天、柯君医药、恒敬合创、赛蕴生物等多家公司完成新一轮融资； 从金额来看，眼科疗法研发公司 EyePoint 融资金额最高，融资金额达 1.4 亿美元。 下面，Insight 数据库将节选部分备受关注的融资案例做介绍，仅供读者参阅。 中国新锐融资   华昊中天在港挂牌上市 华昊中天在港交所上市，发行价为 16 港元/股，此次发售 1458.8 万股，募资总额为 2.33 亿港元（约 2 亿元）。华昊中天是一家合成生物学技术驱动的生物医药公司，致力于开发肿瘤创新药。 华昊中天的产品研发管线涵盖 1 款已商业化的产品和 19 款在研项⽬。其中，新一代微管抑制剂优替德隆注射液（商品名：优替帝）已于 2021 年 3 月在中国获批上市，用于晚期和转移性乳腺癌的治疗。   恒敬生物获超 2 亿元 A 轮/A+轮融资 恒敬生物完成合计约 2.5 亿元 A 轮和 A+轮融资，投资者包括上海张科领弋和老股东，也有创始团队自筹资金。本次融资主要用于该公司在研产品的临床研究、生产项目建设、日常运营等。 恒敬生物由范豪博士创办于 2021 年，专注于从事以胰岛素和 GLP-1 受体激动剂为代表的生物类似药、生物创新药、生物制品的产业化。目前，该公司已搭建起一套原核细胞基因工程生产重组蛋白的技术平台，并开展了从原料药到 CDMO 服务、产品研发和生产的全产业链布局。   赛蕴生物完成天使轮融资 赛蕴生物宣布完成由生命园创投基金与知名基金联合领投的数千万元天使轮融资，其他投资人还有英诺天使基金等。本轮融资将为赛蕴生物的发展提供支持，同时通过与国内科研机构和医院的合作，该公司有望在新型递送载体开发、管线推进等方面取得更多进展。 赛蕴生物致力于开发蛋白和核酸靶向的递送载体技术及相关药物创新疗法。该公司研发的天然递送系统可经过理性改造，将功能性生物大分子等各种类型的有效载荷直接递送至特定细胞中，具有细胞识别的高特异性、对载荷的高兼容性和保护性及生产成本低等优势。   柯君医药完成 B+轮阶段性融资 柯君医药宣布完成由国信创新股权领投的 B+轮阶段性融资，其他投资人还有谊安集团、英飞尼迪资本、宏海资本等。本次融资将用于加速推进该公司心脑血管领域核心产品 CG-0255 的临床开发进程。 柯君医药成立于 2018 年，专注于小分子及核酸药物研发。CG-0255 是其自主研发的新一代抗血小板药物，属于 P2Y12 受体拮抗剂，目前正在美国推进注册临床工作。另外，柯君医药在抗病毒领域也布局了抗广谱呼吸道抗病毒药物、慢性乙肝功能性治愈等多个管线。 海外新锐融资   EyePoint 完成 1.4 亿美元融资 EyePoint Pharmaceuticals 宣布以每股 11.00 美元的公开发行价格承销其 1272 多万股普通股，此次发售的总收益预计约为 1.4 亿美元。本次融资主要用于推进该公司 Duravyu 治疗湿性年龄相关性黄斑变性（湿性 AMD）和糖尿病性黄斑水肿（DME）的药物临床开发，并支持其早期管线开发计划等。 EyePoint 致力于开发和商业化创新疗法，以改善严重视网膜疾病患者生活，其专有的生物可再生 Durasert E 技术可用于持续的眼内药物输送。该公司的主要候选产品 Duravyu 是一种针对 VEGF 介导的视网膜疾病的持续递送治疗方法，目前正在进行全球关键 Ⅲ 期临床试验。   Axonis 完成 1.15 亿美元 A 轮融资 Axonis Therapeutics 宣布完成由 Cormorant Asset Management 和 venBio Partners 共同领投的 1.15 亿美元 A 轮融资，其他投资人还有 Sofinnova investments、MRL Ventures Fund、Perceptive Advisors、Lumira Ventures 和 Solasta Ventures 等。 Axonis 公司专注于开发新型神经药物。本轮融资将用于推进该公司主要候选药物 AXN-027 的临床概念验证，以及新一代靶向 KCC2 化合物的开发。AXN-027 是一种潜在「first-in-class」的口服小分子药物，拟开发适应症包括癫痫和疼痛。本轮融资还将支持其新一代靶向 KCC2 化合物的开发，覆盖癫痫、疼痛、精神类和神经发育类疾病等适应症。   Evommune 完成 1.15 亿美元 C 轮融资 Evommune 公司宣布完成由 RA Capital Management 和 Sectoral Asset Management 共同领投的 1.15 亿美元 C 轮融资，其他投资人还有 B Capital、Marshall Wace、Avego Bioscience Capital、Longwood Fund、RTW Investments 等。 本次融资将用于支持 Evommune 公司 MRGPRX2 抑制剂 EVO756 及 IL-18 靶向融合蛋白疗法 EVO301 的临床开发。其中，EVO756 是一种口服、强效、高选择性的 MRGPRX2 小分子拮抗剂，EVO301 是一种长效、与血清白蛋白结合的融合蛋白注射疗法。该公司预计于 2025 年和 2026 年公布这些疗法在慢性荨麻疹和特应性皮炎患者中的多个 Ⅱ 期试验数据。   Kivu 完成 9200 万美元 A 轮融资 Kivu Bioscience 宣布完成由 Novo Holdings 领投的 9200 万美元 A 轮融资，其他投资人还有 Gimv、Red Tree Venture Capital、HealthCap、BioGeneration Ventures 等。本次融资将用于推进 Kivu 公司多个肿瘤学项目进入临床阶段。 Kivu 公司专注于使用其专有的 Synaffix 位点特异性连接载荷技术来开发下一代 ADC 疗法，该技术可以显著提高 ADC 的稳定性，减少潜在副作用。目前，Kivu 公司的研发项目处于临床前研究后期，其中主导候选药物有望于 2025 年启动 Ⅰ 期临床试验。   Blue Earth 完成 7650 万美元 A 轮融资 Blue Earth Therapeutics 宣布完成由 Soleus Capital 和 Sands Capital Management 领投的 7650 万美元 A 轮融资，其他投资人还有 Bracco Imaging SpA、Woodline Partners 和 PBM Capital。本轮融资将帮助该公司进一步推进其临床阶段的前列腺特异性膜抗原（PSMA）靶向放射性配体疗法的开发。 Blue Earth 致力于开发治疗性放射性药物，用于治疗癌症患者。目前，该公司已建立系列产品管线，包括两款 rhPSMA 分子，一个使用发射β射线的放射性同位素镥 177（177Lu），另一个使用发射α射线的锕 225（225Ac）。其中，基于 177Lu 的放射性配体疗法已经进入 Ⅰ 期临床试验，用于治疗前列腺癌患者。   Pathos AI 完成 6200 万美元 C 轮融资 Pathos AI 宣布完成由 New Enterprise Associates（NEA）牵头的 6200 万美元 C 轮融资，其他投资人还有 Revolution Growth 等。本轮融资将使 Pathos AI 能够扩大其科学家和工程师团队，加速其人工智能药物开发平台的开发，并推进其精准肿瘤治疗的临床阶段管线。 Pathos AI 专注于通过人工智能重新设计药物开发，曾在过去一年内收购了两项临床阶段精准肿瘤学资产，如脑渗透性 PRMT5 抑制剂 P-500，并计划在 2025 年启动下一项临床试验。   Leal Therapeutics 完成 4500 万美元融资 Leal Therapeutics 宣布完成由 Newpath Partners 领投的 4500 万美元融资，其他投资人还有 Orbidden、Euclidean Capital、PhiFund、Chugai Venture Fund 和 Alexandria Venture Investments。本轮融资将用于推进该公司针对中枢神经系统（CNS）疾病的反义寡核苷酸（ASO）和小分子疗法产品管线。 Leal Therapeutics 是一家为 CNS 疾病患者开发新型疗法的生物技术公司。其主要在研项目包括治疗肌萎缩侧索硬化（ALS）的 ASO 疗法 LTX-002，以及针对精神分裂症患者的小分子药物 LTX-001。该公司计划在 2024 年底前提交 LTX-002 和 LTX-001 的 IND 申请，并在 2025 年初启动首次人体临床试验。   Eupraxia 完成 4450 万加元融资 Eupraxia Pharmaceuticals 宣布已完成一笔 4450 万加元的私募融资，融资所得将用于资助其在研产品 EP104 GI 的临床试验，以及为新候选药启动研究计划等。 Eupraxia 是一家临床阶段生物技术公司，正利用其专有的 DiffuSphere 技术优化药物输送，以解决医疗需求未得到满足的治疗领域。EP-104 GI 是一款嗜酸性食管炎潜在疗法，采用食管壁注射给药方式，目前正在进行 Ⅰb/Ⅱa 期试验。   Celaid 完成 1.4 亿日元融资 Celaid Therapeutics 宣布已从 KUC1 Investment Limited Partnership 和 Techno Science 获得总计 1.4 亿日元资金支持。此外，该公司还收到现有投资者 Techno Science 的进一步投资，使其 A 轮融资总额达到 11 亿日元（不包括赠款）。本次融资预计将进一步加快 Celaid 公司的管线开发和平台业务活动。 Celaid 是一家造血干细胞（HSC）初创公司，拥有选择性体外 HSC 扩增的专有技术，旨在提供下一代细胞和基因治疗产品，用于血液病的细胞治疗、遗传疾病的离体 HSC 基因治疗以及缺血性疾病的血管生成等。 除了上述案例，上周还有一些其它公司也获得了融资，限于篇幅，此处不再一一介绍。欲了解上周更多融资信息，请点击「阅读原文」前往 Insight 数据库「新药投融资」模块查看。 封面来源：站酷海洛 Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验 点击阅读原文，立刻解锁！