4DMT Provides Company Update and Anticipated Development Milestones for 2026

Rhea-AI Summary

4D Molecular Therapeutics (Nasdaq: FDMT) provided a 2026 corporate update highlighting accelerated late-stage retinal programs, leadership changes and financial runway. Key clinical milestones include an increased 4FRONT Phase 3 target enrollment to 480 patients per trial (≈90% power), 381 patients randomized or approved to randomize in 4FRONT-1 as of Jan 6, 2026, with North America enrollment on track to complete in Q1 2026 and topline data expected in H1 2027. Ex-U.S. enrollment for 4FRONT-2 aims to finish in H2 2026 with topline in H2 2027. PRISM 2-year Phase 2b data expected mid-2026; SPECTRA 2-year data and DME Phase 3 plans expected in H2 2026. Leadership updates include board addition Glenn Sblendorio and executive promotions, and cash of $514 million is expected to fund operations into H2 2028.

Positive

• Enrollment raised to 480 patients per 4FRONT trial (~90% power)
• 381 patients randomized/approved in 4FRONT-1 as of Jan 6, 2026
• Topline timing set: 4FRONT-1 H1 2027, 4FRONT-2 H2 2027
• $514 million cash expected to fund operations into H2 2028

Negative

• 4D-175 development paused pending additional financing or partnerships

Key Figures

4FRONT target enrollment 480 patients per trial Global Phase 3 wet AMD program target increased from 400

4FRONT-1 enrollment 381 patients Randomized or approved to randomize as of Jan 6, 2026

Statistical power 90% power Phase 3 noninferiority margin of 4 letters for wet AMD

Noninferiority margin 4 letters Visual acuity margin aligned with PMDA and EMA

Cash & securities $514 million Unaudited balance as of Dec 31, 2025

Runway guidance Into H2 2028 Funding for currently planned operations

4D-150 PRISM data 2-year Phase 2b Wet AMD data expected mid-2026

4D-150 DME Phase 3 Global initiation H2 2026 Planned Phase 3 diabetic macular edema trial

Market Reality Check

$7.77 Last Close

Volume Volume 522,212 is below the 20-day average of 1,178,346 (relative volume 0.44). low

Technical Price $7.19 is trading above the 200-day MA of $6.49 while still 41.73% below the 52-week high.

Peers on Argus

FDMT was down 1.51% while peers showed mixed moves, from -2.48% (MBX) to gains of 5.48% (OCGN) and 4.26% (TECX), suggesting a stock-specific reaction.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 17	Clinical data update	Positive	-20.1%	Positive interim Phase 1 data for 4D-710 in cystic fibrosis lung disease.
Dec 12	Equity awards	Neutral	+1.0%	Inducement RSU grants to new employees under employment award plan.
Dec 08	Conference participation	Neutral	+3.5%	Announcement of presentation at J.P. Morgan Healthcare Conference with webcast.
Nov 20	Conference participation	Neutral	-4.3%	Participation in Evercore Healthcare Conference fireside chat and meetings.
Nov 17	Executive appointment	Positive	+1.5%	Appointment of Kristian Humer as CFO to support Phase 3 and commercialization.

Pattern Detected

Positive or high-profile clinical and corporate updates have sometimes seen muted or negative next-day price reactions, while routine corporate items have produced modest gains or small declines.

Recent Company History

Over the past few months, 4DMT reported several notable milestones. On Nov 6–10, 2025, the company highlighted strong PRISM data for 4D-150 and a sizeable cash position, followed by an underwritten offering supported by an effective S-3. In November 2025, it appointed a new CFO with a significant equity package, reinforcing its late-stage and commercial ambitions. In December 2025, positive interim Phase 1 data for 4D-710 in cystic fibrosis preceded today’s broader 2026 development and leadership update.

Market Pulse Summary

The stock moved +8.1% in the session following this news. A strong positive reaction aligns with the company’s late-stage profile and the detailed 2026 roadmap. The update highlighted expanded Phase 3 enrollment in wet AMD, clear timelines for DME and SPECTRA data, and cash of $514 million funding operations into H2 2028. Historically, even good trial news saw mixed price responses, so traders often weighed dilution history and insider activity when judging whether momentum could persist.

Key Terms

phase 3 medical

"4D-150 Phase 3 wet AMD clinical trials exceeding expectations; 4FRONT-1..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 2b medical

"4D-150 PRISM wet AMD 2-year Phase 2b data expected mid-2026"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

noninferiority margin medical

"Provides approximately 90% power with a noninferiority margin of 4 letters..."

A noninferiority margin is a pre-set cutoff in clinical trials that defines how much less effective a new treatment can be compared with an existing standard and still be considered acceptable. Think of it like agreeing that a new phone can have slightly shorter battery life but must be close enough to the leader to be useful. Investors care because the margin shapes trial success, regulatory approval likelihood, marketability and ultimately a product’s commercial value.

wet age-related macular degeneration medical

"4D-150 for Wet Age-related Macular Degeneration: 4FRONT Global Phase 3 Program"

A severe eye condition in which abnormal, fragile blood vessels grow beneath the macula — the small central part of the retina responsible for sharp, detailed vision — and leak fluid or blood, causing rapid loss of central sight. Investors care because the condition drives demand for high-cost therapies, medical devices and ongoing care; successful treatments can create sizable markets, affect healthcare spending and influence regulatory and reimbursement decisions, much like fixing a leaking camera lens restores image quality and value.

diabetic macular edema medical

"4D-150 for Diabetic Macular Edema: 2-year SPECTRA Phase 1/2 clinical trial data..."

Diabetic macular edema is an eye condition in which fluid leaks into and swells the macula, the part of the retina used for sharp, central vision, often as a complication of diabetes. For investors it matters because it drives demand for medicines, medical devices and eye-care services, influences clinical trial and regulatory outcomes, and can affect healthcare costs and revenue forecasts—think of the macula as the camera’s central lens that becomes blurred when it soaks up excess fluid.

geographic atrophy medical

"4D-175 in Geographic Atrophy: Additional clinical development pending financing..."

Geographic atrophy is a progressive eye condition in which patches of light-sensing cells in the retina die, causing growing blind spots and ultimately significant central vision loss. For investors, it matters because the condition defines the market size and urgency for drugs, devices, and diagnostics — like a spreading hole in a photograph that companies aim to stop or repair — so clinical results, approvals, and reimbursement determine potential revenue and risk.

cystic fibrosis medical

"4D-710 in Cystic Fibrosis Lung Disease: Phase 2 ongoing..."

A genetic disease that causes the body to produce thick, sticky mucus that clogs airways and digestive passages, leading to ongoing lung infections, breathing difficulty, and problems absorbing nutrients. For investors, cystic fibrosis matters because treatments range from symptom management to pricey, targeted drugs that can change patient outcomes; progress in therapies, clinical trial results, regulatory approvals, and reimbursement decisions can significantly affect the commercial value of companies working in this area.

marketable securities financial

"Company had $514 million in cash, cash equivalents and marketable securities..."

Marketable securities are financial assets — such as publicly traded stocks, bonds, and short-term government bills — that a company can quickly sell for cash at a known price. Investors watch them because they show how much ready cash a company can access without selling core operations, like keeping money in a highly liquid savings account versus being tied up in a house, and they affect short-term risk, financial flexibility, and balance-sheet strength.

AI-generated analysis. Not financial advice.

• 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

Presentation Date:	Wednesday, Jan. 14, 2026
Presentation Time:	7:30 a.m. PT
Webcast Link:	Webcast

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
Media@4DMT.com

Investors:
Julian Pei
Head of Investor Relations and Strategic Finance
Investor.Relations@4DMT.com

FAQ

What enrollment target did 4DMT set for the 4FRONT Phase 3 trials (FDMT)?

4DMT increased the target to 480 patients per trial, providing ~90% power with a 4-letter noninferiority margin.

How many patients were randomized in 4FRONT-1 as of Jan 6, 2026 for FDMT?

381 patients were randomized or approved to randomize in 4FRONT-1 as of Jan 6, 2026.

When does 4DMT expect topline data for 4FRONT-1 and 4FRONT-2 (FDMT)?

Topline data are expected for 4FRONT-1 in H1 2027 and for 4FRONT-2 in H2 2027.

What are the timing expectations for PRISM and SPECTRA data for FDMT?

PRISM 2-year Phase 2b data are expected mid-2026; SPECTRA 2-year Phase 1/2 data are expected H2 2026.

When does 4DMT plan to start the global Phase 3 DME trial for FDMT?

4DMT expects Phase 3 trial initiation for DME in H2 2026 with trial design finalized mid-2026.

How long is 4DMT's reported cash runway based on the Jan 7, 2026 update (FDMT)?

The company reported $514 million in cash and marketable securities, expected to fund operations into H2 2028.