4D-150

Completed enrollment in 4D-150 4FRONT-1 wet AMD Phase 3 trial within approximately 11 months, ahead of initial projections and reflecting strong interest from investigators and patients; topline data expected in H1 2027 PRISM wet AMD Phase 2b 2-year data expected in mid-2026 and SPECTRA DME trial 2-year data in H2 2026 4D-150 DME global Phase 3 trial initiation expected in Q3 2026 $514 million in cash, cash equivalents and marketable securities expected to fund current operating plan into second half of 2028 EMERYVILLE, Calif., March 18, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported full year 2025 financial results, provided operational highlights and outlined expected upcoming milestones. “2025 was a transformative year for 4DMT highlighted by meaningful progress advancing 4D-150 with rapid Phase 3 trial enrollment, presenting strong 4D-150 Phase 1/2 durability data, entering a strategic partnership with Otsuka and strengthening our financial position,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “These achievements position us well for execution in 2026 and beyond as we continue toward our goal of redefining the treatment paradigm for retinal vascular disease with 4D-150, with our first pivotal data readout for wet AMD expected in the first half of 2027.” Recent Corporate Highlights Expanded Leadership to Support Late-Stage Execution and Commercial Readiness Glenn P. Sblendorio joined the 4DMT Board of Directors and will serve on the Compensation and Science & Technology committees Kristian Humer joined as Chief Financial Officer Julie Clark, M.D., was promoted to Chief Medical Officer Katy Barglow, Ph.D., was promoted to Chief Technical Officer Kim Maplestone was promoted to Chief Clinical Operations Officer Chris Simms’ role expanded to Chief Commercial & Business Officer Entered Strategic Partnership with Otsuka Pharmaceutical Co., Ltd. for 4D-150 in Asia-Pacific Region 4DMT received $85 million upfront cash payment in the fourth quarter of 2025 and expects to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supporting global registration The Company is eligible for up to $336 million in potential regulatory and commercial milestones and tiered double-digit royalties 4DMT retains full development and commercialization rights for 4D-150 outside the Asia-Pacific region, including in the U.S., Europe and Latin America Strengthened Balance Sheet Position with $118 Million Financing, Extending Cash Runway into H2 2028 In October 2025, secured an equity investment from the Cystic Fibrosis (CF) Foundation of up to $11 million in two tranches, with the first tranche of $7.5 million received upfront, to accelerate the development of 4D-710 for the treatment of CF lung disease In October 2025, raised gross proceeds of $10 million from sale of common stock through at-the-market offering facility In November 2025, completed an equity offering with gross proceeds of $100 million before underwriting discounts, commissions and offering expenses, resulting in net proceeds of approximately $93 million Glenn P. Sblendorio joined the 4DMT Board of Directors and will serve on the Compensation and Science & Technology committees Kristian Humer joined as Chief Financial Officer Julie Clark, M.D., was promoted to Chief Medical Officer Katy Barglow, Ph.D., was promoted to Chief Technical Officer Kim Maplestone was promoted to Chief Clinical Operations Officer Chris Simms’ role expanded to Chief Commercial & Business Officer 4DMT received $85 million upfront cash payment in the fourth quarter of 2025 and expects to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supporting global registration The Company is eligible for up to $336 million in potential regulatory and commercial milestones and tiered double-digit royalties 4DMT retains full development and commercialization rights for 4D-150 outside the Asia-Pacific region, including in the U.S., Europe and Latin America In October 2025, secured an equity investment from the Cystic Fibrosis (CF) Foundation of up to $11 million in two tranches, with the first tranche of $7.5 million received upfront, to accelerate the development of 4D-710 for the treatment of CF lung disease In October 2025, raised gross proceeds of $10 million from sale of common stock through at-the-market offering facility In November 2025, completed an equity offering with gross proceeds of $100 million before underwriting discounts, commissions and offering expenses, resulting in net proceeds of approximately $93 million Recent Highlights and Expected Milestones for 4D-150 4D-150 for Wet Age-related Macular Degeneration: 4FRONT Global Phase 3 Program: To further the potential for global regulatory success, target enrollment for both the 4FRONT-1 and the 4FRONT-2 Phase 3 clinical trials was increased from 400 to 480 patients per trial Provides approximately 90% power with a noninferiority margin of 4 letters as aligned with the Japan Pharmaceuticals and Medical Devices Agency and European Medicines Agency 4FRONT-1, North American Clinical Trial: Enrollment completed in February 2026 with over 500 patients expected to be randomized; topline data expected in H1 2027 4FRONT-2, Global Clinical Trial: Ex-U.S. site activation and patient screening accelerating across Europe and Asia-Pacific; enrollment remains on track to be completed in H2 2026, with topline data expected in H2 2027 PRISM Phase 1/2 Clinical Trial: Announced positive long-term interim results (data cutoff: August 22, 2025) 4D-150 demonstrated consistent and durable benefit across all three patient cohorts as evidenced by maintenance of visual acuity, control of retinal anatomy and reduction of treatment burden at all time points with 1.5-2 years of follow-up Consistent dose response in favor of Phase 3 dose (3E10 vg/eye) continues to be demonstrated across all wet AMD cohorts studied 4D-150 continues to be well tolerated with no new safety or intraocular inflammation findings with up to 3.5 years of follow-up 2-year Phase 2b data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, expected to be presented at a scientific conference in mid-2026 4D-150 for Diabetic Macular Edema: 2-year SPECTRA Phase 1/2 clinical trial data expected in H2 2026 Phase 3 trial design expected mid-2026 Global Phase 3 trial initiation expected in Q3 2026 4FRONT Global Phase 3 Program: To further the potential for global regulatory success, target enrollment for both the 4FRONT-1 and the 4FRONT-2 Phase 3 clinical trials was increased from 400 to 480 patients per trial Provides approximately 90% power with a noninferiority margin of 4 letters as aligned with the Japan Pharmaceuticals and Medical Devices Agency and European Medicines Agency 4FRONT-1, North American Clinical Trial: Enrollment completed in February 2026 with over 500 patients expected to be randomized; topline data expected in H1 2027 4FRONT-2, Global Clinical Trial: Ex-U.S. site activation and patient screening accelerating across Europe and Asia-Pacific; enrollment remains on track to be completed in H2 2026, with topline data expected in H2 2027 PRISM Phase 1/2 Clinical Trial: Announced positive long-term interim results (data cutoff: August 22, 2025) 4D-150 demonstrated consistent and durable benefit across all three patient cohorts as evidenced by maintenance of visual acuity, control of retinal anatomy and reduction of treatment burden at all time points with 1.5-2 years of follow-up Consistent dose response in favor of Phase 3 dose (3E10 vg/eye) continues to be demonstrated across all wet AMD cohorts studied 4D-150 continues to be well tolerated with no new safety or intraocular inflammation findings with up to 3.5 years of follow-up 2-year Phase 2b data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, expected to be presented at a scientific conference in mid-2026 To further the potential for global regulatory success, target enrollment for both the 4FRONT-1 and the 4FRONT-2 Phase 3 clinical trials was increased from 400 to 480 patients per trial Provides approximately 90% power with a noninferiority margin of 4 letters as aligned with the Japan Pharmaceuticals and Medical Devices Agency and European Medicines Agency 4FRONT-1, North American Clinical Trial: Enrollment completed in February 2026 with over 500 patients expected to be randomized; topline data expected in H1 2027 4FRONT-2, Global Clinical Trial: Ex-U.S. site activation and patient screening accelerating across Europe and Asia-Pacific; enrollment remains on track to be completed in H2 2026, with topline data expected in H2 2027 Provides approximately 90% power with a noninferiority margin of 4 letters as aligned with the Japan Pharmaceuticals and Medical Devices Agency and European Medicines Agency Enrollment completed in February 2026 with over 500 patients expected to be randomized; topline data expected in H1 2027 Ex-U.S. site activation and patient screening accelerating across Europe and Asia-Pacific; enrollment remains on track to be completed in H2 2026, with topline data expected in H2 2027 Announced positive long-term interim results (data cutoff: August 22, 2025) 4D-150 demonstrated consistent and durable benefit across all three patient cohorts as evidenced by maintenance of visual acuity, control of retinal anatomy and reduction of treatment burden at all time points with 1.5-2 years of follow-up Consistent dose response in favor of Phase 3 dose (3E10 vg/eye) continues to be demonstrated across all wet AMD cohorts studied 4D-150 continues to be well tolerated with no new safety or intraocular inflammation findings with up to 3.5 years of follow-up 2-year Phase 2b data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, expected to be presented at a scientific conference in mid-2026 4D-150 demonstrated consistent and durable benefit across all three patient cohorts as evidenced by maintenance of visual acuity, control of retinal anatomy and reduction of treatment burden at all time points with 1.5-2 years of follow-up Consistent dose response in favor of Phase 3 dose (3E10 vg/eye) continues to be demonstrated across all wet AMD cohorts studied 4D-150 continues to be well tolerated with no new safety or intraocular inflammation findings with up to 3.5 years of follow-up 2-year SPECTRA Phase 1/2 clinical trial data expected in H2 2026 Phase 3 trial design expected mid-2026 Global Phase 3 trial initiation expected in Q3 2026 Recent Highlights and Expected Milestones in 4D-710 Program for CF Lung Disease Announced positive long-term interim results from the AEROW Phase 1/2 clinical trial (data cut-off: December 1, 2025) Clinically meaningful lung function activity, measured by ppFEV1 and LCI2.5, with follow-up through 1 year at dose selected for Phase 2 Durable CFTR transgene expression within target therapeutic range with follow-up through at least 1 year Phase 2 ongoing, fully funded by the Cystic Fibrosis Foundation, with program update expected in H2 2026 Clinically meaningful lung function activity, measured by ppFEV1 and LCI2.5, with follow-up through 1 year at dose selected for Phase 2 Durable CFTR transgene expression within target therapeutic range with follow-up through at least 1 year Full Year 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $514 million as of December 31, 2025. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, and expected payments under our collaboration agreement with Otsuka, will be sufficient to fund our operating expenses and capital expenditure requirements at least into the second half of 2028. Collaboration and License Revenue: Collaboration and license revenue was $85 million for the year ended December 31, 2025, as compared to $0 million for the year ended December 31, 2024. This increase was primarily due to the $85 million upfront cash payment related to the Otsuka collaboration agreement. R&D Expenses: Research and development expenses were $196 million for 2025, as compared to $141 million for 2024. This increase was primarily driven by execution of 4D-150 Phase 3 clinical trials in wet AMD. G&A Expenses: General and administrative expenses were $49 million for 2025, as compared to $47 million for 2024. Net Loss: Net loss was $140 million for 2025, as compared to net loss of $161 million for 2024. About 4DMT 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development of our product candidates, the potential benefits of the strategic partnership with Otsuka, the amount of any potential cost sharing or milestone payments pursuant to the Company’s agreement with Otsuka, the Company’s use of proceeds, the potential benefits of the investment from and collaboration with the CF Foundation, the potential additional second tranche funding from the CF Foundation and statements regarding our financial performance, results of operations and anticipated cash runway. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Annual Report on Form 10-K filed on or about the date hereof, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contacts: Media: Jenn Gordon dna CommunicationsMedia@4DMT.com Investors: Julian Pei Head of Investor Relations and Strategic Finance Investor.Relations@4DMT.com

上文提要百济主要股东之一，专营于生物制药投资的Baker Bros在2025年Q4的持仓市值出现了巨额增加，这增加由Baker Bros增持和公司股价飙升双重驱动，本文将简要分析Q4 Baker Bros新建仓的几家Biotech。 Terns Pharmaceuticals Terns Pharmaceuticals在Q4的表现可以说是起起伏伏，有喜有忧，忧是公司核心管线之一的口服GLP-1受体激动剂TERN-601数据表现不佳，达不到差异化门槛，公司因此退出代谢药物市场。 喜的是另外一款CML（慢性粒细胞白血病）药物新一代BCR-ABL变构抑制剂TERN-701的I期临床数据优异，获得历史最佳MMR数据，有望从I期临床直接跳到III期临床。 或许Terns Pharmaceuticals会成为一个很好的收购标的对象。 Jade Biosciences Jade Biosciences这公司很有意思，成立了一年多就借壳上市，公司本身管线来自于Paragon Therapeutics。 Paragon Therapeutics这公司并未上市，而是类似于孵化器，把管线授权出去，然后在同一资本运作下，让授权公司上市，这套流程下来公司已经成立了Paragon Therapeutics系列上市公司。 而Jade就是其中之一，该公司在第四季度首先是阐述了关于APRIL抗体JADE101临床前安全数据和预计发布的BAFF-R抗体JADE201，接下来还预告了公司的未来节点，例如预计在2026年上半年发布JADE101在免疫球蛋白A肾病(IgAN)患者中的I期临床数据。这些消息使得公司在2025年第四季度呈现出总体上涨态势。 未来大概可以等一等这次数据对股价的催化…… BioCryst Pharmaceuticals BioCryst Pharmaceuticals这公司在2024年曾经被Baker Bros清仓过（可能在当时的高点抛售了），23年时曾经是Baker Bros前十大持仓之一。导致现在又重新被建仓的原因大概是商业化做的不错，这公司主打的罕见病管线ORLADEYO（berotralstat）收入增长38%，第四季度表现尤为强劲，收入1.51亿美元，同比增长22%，公司借此首次实现了全年非GAAP盈利。 另外今年10月公司还与Astria Therapeutics达成了收购协议，获得了HAE管线Navenibart，最近公司还与Blackstone Life Sciences签订了4亿美元的融资协议，未来公司有望在ORLADEYO商业化不断提供现金流的基础上利用Navenibart来获得更多潜力。 Centessa Pharmaceuticals Centessa Pharmaceuticals这次被看上的原因可能是公司核心管线即将在2026年上半年迎来关键节点，公司目前主推食欲素受体2（OX2R）激动剂ORX750作为核心管线，其治疗发作性睡病1型（NT1）、2型（NT2）和特发性嗜睡症（IH）的Phase 2a CRYSTAL-1研究进展顺利，临床前数据有Best-in-Class的潜力，数据预计将在2026年上半年公布。 其他管线如ORX142和ORX489（分别针对其他神经和神经精神疾病）也正在稳步推进IND申报工作。 Dyne Therapeutics Baker Bros在去年Q2清仓了Dyne Therapeutics，现在又建仓该公司，当时由于Dyne Therapeutics公司推迟AOC药物DYNE-101的上市计划，由于预期被拖延到2026年年末提交申请实在有点长，导致股价缩水。 现在公司又表示，DYNE-101会在2026年第二季度提交BLA，2027年年初有望获批，期待阈值一下子被拉高了。 Absci Corporation Absci Corporation这公司是做合成生物学起家的，现在2025年年末，公司在合成生物学的标签之外又加上了AI，9月又与甲骨文和AMD达成三方战略合作，为其AI模型获得了顶尖的算力基础设施。2026年1月JPM大会上，公司发布了新一代AI模型 Origin-1，能针对传统上“不可成药”的靶点（如GPCRs）进行抗体设计 对于这家公司来说，Q4有喜有忧，忧的是TL1A抗体ABS-101的临床数据未达预期，公司打算搁置其临床对外寻求合作。喜的则是治疗雄激素性脱发的 ABS-201的临床前数据不错，机制新颖。 Arcus Biosciences Arcus Biosciences这公司很多人应该不陌生，随着TIGIT赛道的逐渐没落，这家公司也开始转型搞起了其他靶点，更在Q4中断了和吉利德的合作，现在利空尽出，得找到新卖点。而现在这家公司重注的是HIF-2α抑制剂 casdatifan。在今年2月公司发布的数据显示，casdatifan在肾细胞癌上的数据非常优异，远超目前已上市的同类药物，有着Best-in-Class的潜力。 MapLight Therapeutics MapLight Therapeutics是Q4才上市的新股，做的是已有毒蕈碱激动剂Cobenfy的Fast-Follow，核心管线为M1/M4毒蕈碱激动剂ML-007C-MA，不过MapLight主打的是减少副作用和优化给药的差异化布局。II期临床数据预计2026年下半年给出。 公司还带着5-HT1B/1D激动剂ML-004（2026年下半年公布II期临床数据），M4拮抗剂ML-021（2026年下半年IND）等管线的预期节点出现。 4D Molecular Therapeutics 4D Molecular Therapeutics是这个名单上罕见的基因治疗公司，公司在Q4节点上获得大药企的认可。 2025年11月，4DMT与日本大塚制药达成战略合作伙伴关系，共同开发和商业化4D-150。公司将获得8500万美元的预付款和至少5000万美元的研发成本成本分摊。 2026年下半年该公司将迎来4D-150管线的多个临床数据发布节点。 参考来源：各公司官网