4DMT Provides Company Update and Anticipated Development Milestones for 2026

• Enrollment in 4D-150 Phase 3 wet AMD clinical trials exceeding expectations; 4FRONT-1 trial remains on track to complete enrollment in Q1 2026, with 381 patients randomized or approved to randomize as of January 6, 2026
• 4D-150 PRISM wet AMD 2-year Phase 2b data expected mid-2026
• 4D-150 DME global Phase 3 trial initiation expected Q3 2026; 2-year SPECTRA Phase 1/2 data expected H2 2026
• Appointed Glenn Sblendorio to Board of Directors, adding deep commercial and operating experience, including in retina therapeutics
• Company to present strategic outlook at the 44^th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, at 7:30am PT
  
  
  
  

EMERYVILLE, Calif., Jan. 07, 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 provided a corporate update and outlook for 2026.

Expected Milestones for 4D-150 in Retinal Vascular Disease

• 4D-150 for Wet Age-related Macular Degeneration:  
  • 4FRONT Global Phase 3 Program:
    • To further the potential for global regulatory success, target enrollment 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: 
      • 381 patients randomized or approved to randomize as of January 6, 2026; enrollment remains on track to be completed in Q1 2026, with 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:
    • • 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 H2 2026
  • Phase 3 trial design expected mid-2026
  • Global Phase 3 trial initiation expected in H2 2026
    
    
    
    

Leadership Evolution 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. Mr. Sblendorio most recently served as President and Chief Executive Officer of IVERIC Bio through its acquisition by Astellas Pharma in July 2023. Prior to IVERIC Bio, Mr. Sblendorio was President and Chief Financial Officer of The Medicines Company, and previously held senior executive roles at Eyetech Pharmaceuticals. Mr. Sblendorio currently serves as a member of the Board of Directors of Amicus Therapeutics (to be acquired by BioMarin), as Chair of the Board of Directors of Mineralys Therapeutics, and previously served as a member of the Board of Directors of Intercept Pharmaceuticals.
• Katy Barglow, Ph.D., was promoted to Chief Technical Officer. Since joining 4DMT in 2017, Dr. Barglow has built and scaled the company's AAV manufacturing and analytical capabilities, including in her previous role as Senior Vice President. As CTO, Dr. Barglow will continue to oversee 4DMT's transition to commercial manufacturing, with responsibility for CMC quality, supply chain, and technical operations.
• Kim Maplestone was promoted to Chief Clinical Operations Officer. Since joining 4DMT in 2019, Ms. Maplestone has played a central role in advancing the Company's clinical programs. In her new role, Ms. Maplestone will continue to oversee global clinical operations across the Company's portfolio, with responsibility for delivering inspection-ready, high-quality data to support regulatory submissions.
• Chris Simms' role expanded to Chief Commercial & Business Officer. Mr. Simms' responsibilities have expanded to include oversight and management of business development, in addition to his existing commercial leadership.
• Fred Kamal, Ph.D., has transitioned from his role as President and Chief Operating Officer to Chief Technical Advisor as a part-time employee, effective January 1, 2026, supporting CMC and regulatory strategy for 4D-150. With this transition, David Kirn, M.D., has assumed the role of President in addition to Chief Executive Officer.
  
  
  
  

"We look forward to continuing our disciplined execution and organizational readiness to potentially commercialize 4D-150 for retinal vascular diseases," said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. "The continued progress in our late-stage development of 4D-150, the evolution of our leadership team and the addition of Glenn Sblendorio to our Board reflects our focus on transitioning to becoming a commercial large market retina therapeutics company. With a strong leadership team and the support of our Asia-Pacific partner Otsuka, we believe 4DMT is well positioned to transform the treatment of retinal vascular diseases, including wet AMD and DME, with 4D-150 globally."

Other Pipeline Programs

• 4D-175 in Geographic Atrophy: Additional clinical development pending financing, including potential partnerships
• 4D-710 in Cystic Fibrosis Lung Disease: Phase 2 ongoing, fully funded by the Cystic Fibrosis Foundation, with program update expected in H2 2026
• 4D-725 in A1AT Lung Disease: Preclinical development ongoing, fully funded by the California Institute for Regenerative Medicine
  
  
  
  

Financial Position

As of December 31, 2025, Company had $514 million in cash, cash equivalents and marketable securities (unaudited), which is expected to fund currently planned operations into the second half of 2028.

44^th Annual J.P. Morgan Healthcare Conference

An archived copy of the webcast will be available for up to one year on the "Investors" section of the 4DMT website at https://ir.4dmoleculartherapeutics.com/events.

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 with retina diseases. 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 (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 the 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, our financial performance, results of operations and anticipated cash runway, expectations regarding the performance and success of our leadership team and recent leadership transitions, and our ongoing collaboration with Cystic Fibrosis Foundation. 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: (i) risks that clinical trial results may not support regulatory approval or demonstrate sustained therapeutic benefit; (ii) risks that our product candidates may not demonstrate sufficient safety or efficacy; (iii) risks related to regulatory approval processes and evolving standards for gene therapies; (iv) risks that 4D Molecular Therapeutics may not receive necessary funding or may require additional capital for its operations and anticipated commercialization; (v) risks related to manufacturing complexity and supply chain for gene therapies; and (vi) risks of competition and rapidly evolving treatment landscape; as well as other risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics' most recent Quarterly Report on Form 10-Q filed on November 10, 2025, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statement represents 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 undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as may be required by law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. 

Contacts:

Media:

Jenn Gordon

dna Communications

[email protected]

Investors:

Julian Pei

Head of Investor Relations and Strategic Finance

[email protected]