4DMT Reports Second Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones

Rhea-AI Summary

4D Molecular Therapeutics (NASDAQ:FDMT) reported Q2 2025 financial results and operational updates, highlighting significant progress in its clinical programs. The company announced an accelerated timeline for its 4D-150 Phase 3 program in wet AMD, with 4FRONT-1 data now expected in H1 2027. Additionally, positive 60-week results were presented from the 4D-150 SPECTRA trial in DME.

Key financial metrics include $417 million in cash as of June 30, 2025, expected to fund operations into 2028. Q2 2025 saw R&D expenses of $48.0 million and a net loss of $54.7 million. The company implemented a 25% workforce reduction, expected to generate annual savings of $15 million.

Clinical progress includes strong enrollment in the 4FRONT-1 trial, early initiation of 4FRONT-2, and positive DME trial results showing favorable tolerability and sustained durability. Both FDA and EMA indicated that a single successful Phase 3 study could support approval in the U.S. and Europe.

Positive

• Cash position of $417 million expected to fund operations into 2028
• Accelerated timeline for 4FRONT-1 Phase 3 data readout to H1 2027
• 25% workforce reduction to generate $15 million annual cost savings
• FDA and EMA alignment that single Phase 3 study could support approval
• Positive 60-week DME trial results showing favorable tolerability
• 78% reduction in injection burden vs projected aflibercept in DME trial
• Received RMAT designation from FDA for 4D-150 in DME treatment

Negative

• Increased net loss to $54.7 million in Q2 2025 from $35.0 million in Q2 2024
• R&D expenses increased 50% year-over-year to $48.0 million
• Cash decreased from $505 million to $417 million in six months

Insights

Biotech Financial Analyst

4DMT shows strong pipeline progress with accelerated Phase 3 timeline for 4D-150, but faces increased costs despite workforce reduction.

4D Molecular Therapeutics' Q2 2025 results present a mixed financial picture combined with notable clinical progress. The company reported $417 million in cash reserves, down from $505 million at the end of 2024, maintaining its runway projection into 2028 despite accelerating development timelines. Q2 net losses widened to $54.7 million from $35.0 million year-over-year, driven primarily by a 50% increase in R&D expenses to $48 million as the company advances its late-stage programs.

The most significant operational development is the acceleration of the 4D-150 wet AMD Phase 3 program, with the 4FRONT-1 data readout now expected in H1 2027 instead of H2 2027 due to stronger-than-anticipated enrollment. This acceleration, coupled with the earlier-than-planned initiation of 4FRONT-2, demonstrates both investigator enthusiasm and efficient clinical execution. However, these accelerated timelines come with increased near-term costs.

To offset these rising expenses, management has implemented a 25% workforce reduction focused on early-stage research and support functions, projecting annual savings of approximately $15 million. This strategic realignment prioritizes late-stage development, potential BLA filing, and commercialization preparations for 4D-150.

The positive 60-week data from the SPECTRA trial in diabetic macular edema (DME) provides additional pipeline validation, with the Phase 3 dose showing a +9.7 letter BCVA improvement and 78% reduction in injection burden versus standard therapy. Importantly, both FDA and EMA have indicated that a single successful Phase 3 study could support approval in wet AMD, potentially streamlining the regulatory pathway and reducing development costs.

Overall, 4DMT is making a calculated trade-off: increasing near-term development investments while streamlining operations to extend runway. The accelerated timelines could potentially bring forward commercialization by 6+ months, which represents significant value in the competitive ophthalmology market if the clinical data continues to support 4D-150's differentiated profile.

Ophthalmology Specialist

4D-150 shows promising durability and safety in wet AMD/DME, potentially offering significant treatment burden reduction with single-injection gene therapy.

The clinical data emerging for 4D-150 in both wet AMD and DME represents a potentially significant advancement in retinal disease management. What stands out most in the 60-week SPECTRA trial results for DME is the substantial reduction in treatment burden—78% fewer injections with the Phase 3 dose compared to standard aflibercept therapy. This level of durability from a single intravitreal injection could fundamentally alter the treatment paradigm for retinal vascular diseases.

The safety profile appears exceptionally clean, with no intraocular inflammation reported at any dose level or timepoint—a critical differentiation from other gene therapy approaches that have previously encountered inflammatory complications. The absence of serious adverse events like hypotony, endophthalmitis, vasculitis, or retinal artery occlusions is particularly reassuring given the permanent nature of gene therapy interventions.

Efficacy signals in the DME SPECTRA trial are encouraging, with the Phase 3 dose demonstrating a +9.7 letter BCVA improvement and 174μm reduction in central subfield thickness. The clear dose-response relationship (with 58% fewer supplemental injections at the highest dose) provides validation of the biological mechanism and supports the selected Phase 3 dose.

The acceleration of the wet AMD Phase 3 program likely reflects strong investigator interest and patient demand, suggesting the clinical community recognizes the potential value of this approach. The alignment with both FDA and EMA that a single successful Phase 3 study could support approval in both wet AMD and DME is unusual and indicates regulatory recognition of the unmet need for durable treatments.

If the durability and efficacy signals are maintained in the Phase 3 trials, 4D-150 could position itself as a potential genetic medicine backbone therapy that meaningfully reduces the treatment burden associated with current anti-VEGF therapies while maintaining vision outcomes—addressing one of the most significant unmet needs in retinal care.

• 4D-150 Phase 3 program in wet AMD advancing ahead of plan, with expected 4FRONT-1 data readout accelerated to H1 2027 from H2 2027 and 4FRONT-2 initiated ahead of schedule
• Presented positive 60-week results from 4D-150 SPECTRA clinical trial in DME
• Streamlined organization to drive late-stage execution
• $417 million in cash, cash equivalents and marketable securities as of June 30, 2025, expected to fund planned operations into 2028 

EMERYVILLE, Calif., Aug. 11, 2025 (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 Q2 2025 financial results, provided operational highlights and outlined expected upcoming milestones. 

“During the past quarter, we advanced our 4D-150 program and streamlined operations to focus on late-stage execution,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “Rapid enrollment in 4FRONT-1 has enabled us to accelerate the topline data expectation to the first half of 2027, and we initiated 4FRONT-2 ahead of schedule. These updates reflect strong team execution and continued enthusiasm from investigators and patients for 4D-150 as a potential genetic medicine backbone therapy in wet AMD. We also aligned our organization around key priorities for 4D-150 in wet AMD: completing Phase 3, filing a BLA and preparing for potential commercialization. In parallel, we reported positive 60-week data from the SPECTRA trial in DME, which continues to support favorable tolerability, sustained durability and meaningful treatment burden reduction. We are pleased to now be aligned with both the FDA and the European Medicines Agency (EMA) that a single successful Phase 3 study could support approval in the U.S. and Europe.”

Recent Corporate Highlights

• Streamlined Organization to Drive Accelerated Phase 3 Development 
  • Announced a workforce reduction of approximately 25% of current and planned roles in July 2025, primarily in the areas supporting early-stage research and development and support functions 
  • The workforce reduction is expected to provide annual cash compensation cost savings of approximately $15 million and offsets additional expenses expected based on the accelerated timelines for the 4FRONT clinical trials and Biologics License Application (BLA) preparation, which supports the Company’s cash runway into 2028, as previously guided
    

Recent Highlights and Expected Milestones for 4D-150

• 4D-150 for Wet Age-related Macular Degeneration (Wet AMD): 
  • 4FRONT Global Phase 3 Program:
    • Initial enrollment and site activation for 4FRONT-1, the North American Phase 3 clinical trial of 4D-150 in wet AMD, have exceeded initial projections, reflecting continued strong engagement and enthusiasm from investigators and patients
      • 52-week topline data expected in H1 2027, accelerated from previous guidance of H2 2027
    • The second Phase 3 trial of 4D-150 in wet AMD, 4FRONT-2, was initiated in June 2025, ahead of schedule
      • 52-week topline data for 4FRONT-2 are expected in H2 2027 
  • PRISM Phase 1/2 Clinical Trial:
    • 2-year data from Phase 1/2a and 18-month data from Phase 2b cohorts expected in Q4 2025  
• 4D-150 for Diabetic Macular Edema (DME):
  • SPECTRA Clinical Trial: 
    • Presented positive 60-week results (data cutoff: May 3, 2025)    
      • Across all patients and dose levels treated to date, 4D-150 continues to be well tolerated, with no intraocular inflammation observed at any timepoint or dose level
        • No subjects required modification to the topical corticosteroid regimen, and all patients are currently off corticosteroids
        • No hypotony, endophthalmitis, vasculitis, choroidal effusions or retinal artery occlusions were reported
        • Mean intraocular pressure was within normal limits  
      • Post-three loading doses of aflibercept, 3E10 vg/eye, the Phase 3 dose demonstrated strong signals of clinical activity, with sustained gain of BCVA of +9.7 letters and reduction of CST of -174 µm from baseline
      • Supplemental injections:
        • Utilized stringent supplemental aflibercept criteria to maximize patient safety while assessing initial clinical activity
        • Clear dose response observed for the Phase 3 dose vs. lower doses (58% fewer injections)
        • Phase 3 dose achieved 78% reduction in injection burden vs. projected on-label aflibercept 2mg Q8W
  • Phase 3 Planning:
    • Following U.S. Food and Drug Administration (FDA) alignment, as communicated in January 2025, EMA is also aligned that a single Phase 3 clinical trial, based on data generated to date for 4D-150 in both the SPECTRA and PRISM clinical trials combined with data from the two ongoing wet AMD Phase 3 clinical trials, would be acceptable as the basis for a marketing authorization application submission for 4D-150 in DME
    • Received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for 4D-150 for the treatment of DME
    • Next steps pending final FDA and EMA alignment on Phase 3 clinical trial design and funding pathway

Recent Highlights and Expected Milestones in Pulmonology Program

• 4D-710 for Cystic Fibrosis Lung Disease: 
  • Completed enrollment of Cohort 4 (n=6) in Phase 1 stage of AEROW clinical trial (completed total enrollment of n=16 participants)
  • Interim data from AEROW clinical trial and program update expected in Q4 2025 
    

Q2 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $417 million as of June 30, 2025, as compared to $505 million as of December 31, 2024. The net decrease in cash was primarily a result of cash used in operations. We currently expect cash, cash equivalents and marketable securities to be sufficient to fund planned operations into 2028.

R&D Expenses: Research and development expenses were $48.0 million for the second quarter of 2025, as compared to $31.9 million for the second quarter of 2024. This increase was primarily driven by the initiation of our first Phase 3 clinical trial of 4D-150 in wet AMD, including increased personnel and professional services to support Phase 3 development.

G&A Expenses: General and administrative expenses were $11.5 million for the second quarter of 2025, as compared to $10.6 million for the second quarter of 2024. This increase was primarily driven by increased use of professional services.

Net Loss: Net loss was $54.7 million for the second quarter of 2025, as compared to net loss of $35.0 million for the second quarter of 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 (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 and interactions with FDA 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 Quarterly Report on Form 10-Q to be 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.

4D Molecular Therapeutics, Inc. Statements of Operations (Unaudited) (in thousands, except share and per share amounts)
		Three months ended June 30,								Six months ended June 30,
		2025				2024				2025				2024
Revenue:
Collaboration and license revenue		$	15			$	5			$	29			$	33
Operating expenses:
Research and development			47,951				31,860				88,650				59,727
General and administrative			11,519				10,601				24,456				20,898
Total operating expenses			59,470				42,461				113,106				80,625
Loss from operations			(59,455	)			(42,456	)			(113,077	)			(80,592	)
Other income, net			4,797				7,503				10,447				13,238
Net loss		$	(54,658	)		$	(34,953	)		$	(102,630	)		$	(67,354	)
Net loss per share, basic and diluted		$	(0.98	)		$	(0.63	)		$	(1.84	)		$	(1.29	)
Weighted-average shares outstanding used in computing net loss per share, basic and diluted			55,927,091				55,282,754				55,836,075				52,277,369

4D Molecular Therapeutics, Inc. Balance Sheet Data (Unaudited) (in thousands)
		June 30,				December 31,
		2025				2024
Cash, cash equivalents and marketable securities		$	417,031			$	505,460
Total assets			473,637				560,384
Total liabilities			52,747				49,778
Accumulated deficit			(678,825	)			(576,195	)
Total stockholders’ equity			420,890				510,606

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 were 4D Molecular Therapeutics (FDMT) key financial results for Q2 2025?

FDMT reported $417 million in cash, R&D expenses of $48.0 million, and a net loss of $54.7 million. The company expects its cash position to fund operations into 2028.

When will 4D Molecular Therapeutics report Phase 3 results for 4D-150 in wet AMD?

FDMT expects to report 4FRONT-1 topline data in H1 2027 (accelerated from H2 2027) and 4FRONT-2 topline data in H2 2027.

What were the key findings from FDMT's 4D-150 SPECTRA trial in DME?

The 60-week results showed favorable tolerability with no intraocular inflammation, sustained BCVA gain of +9.7 letters, CST reduction of -174 µm, and 78% reduction in injection burden vs. projected aflibercept.

How will FDMT's workforce reduction impact the company?

The 25% workforce reduction is expected to provide $15 million in annual cash compensation savings, offsetting expenses from accelerated clinical trials while maintaining cash runway into 2028.

What regulatory developments did FDMT announce for 4D-150?

Both FDA and EMA indicated that a single successful Phase 3 study could support approval in the U.S. and Europe. Additionally, 4D-150 received RMAT designation from FDA for DME treatment.