4D Molecular Therapeutics advances 4D-150 program, extends cash runway to 2028.
PorAinvest
lunes, 11 de agosto de 2025, 8:03 am ET2 min de lectura
FDMT--
Financial Highlights:
- Cash Position: As of June 30, 2025, 4DMT reported $417 million in cash, cash equivalents, and marketable securities, down from $505 million as of December 31, 2024. The company expects this cash to fund planned operations into 2028 [1].
- Research and Development Expenses: R&D expenses for the second quarter of 2025 were $48.0 million, up from $31.9 million in the same period last year. This increase was primarily driven by the initiation of the first Phase 3 clinical trial of 4D-150 in wet AMD [1].
- General and Administrative Expenses: G&A expenses were $11.5 million for the second quarter of 2025, up from $10.6 million in the same period last year, primarily due to increased use of professional services [1].
- Net Loss: The company reported a net loss of $54.7 million for the second quarter of 2025, compared to a net loss of $35.0 million in the same period last year [1].
Clinical Milestones:
- 4D-150 Program: The 4D-150 Phase 3 program for wet AMD is advancing ahead of plan. The topline data readout for 4FRONT-1, the North American Phase 3 clinical trial, has been accelerated to the first half of 2027 from the previous guidance of the second half of 2027. Additionally, 4FRONT-2, the second Phase 3 trial, was initiated in June 2025, ahead of schedule [1].
- SPECTRA Clinical Trial: 4DMT presented positive 60-week results from the SPECTRA clinical trial in DME, demonstrating strong clinical activity and sustained durability. The trial continues to support favorable tolerability and treatment burden reduction [1].
- Pulmonology Program: The company completed enrollment of Cohort 4 in the Phase 1 stage of the AEROW clinical trial for 4D-710, a genetic medicine for cystic fibrosis lung disease. Interim data from this trial and program updates are expected in Q4 2025 [1].
Operational Updates:
- Streamlined Organization: 4DMT announced a workforce reduction of approximately 25% of current and planned roles in July 2025, primarily in early-stage research and development and support functions. This 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 BLA preparation [1].
- Regulatory Alignment: Both the FDA and the European Medicines Agency (EMA) have aligned that a single successful Phase 3 study could support approval in the U.S. and Europe for 4D-150 in DME. The company has received RMAT designation from the FDA for 4D-150 for the treatment of DME [1].
Conclusion:
4D Molecular Therapeutics' Q2 2025 financial results reflect the company's continued focus on advancing its 4D-150 program and streamlining operations to drive late-stage execution. The company's strong cash position and operational efficiency position it well to continue its clinical development efforts through 2028.
References:
[1] https://www.marketscreener.com/news/4dmt-reports-second-quarter-2025-financial-results-operational-highlights-and-expected-upcoming-mil-ce7c5ed2df81f020
• 4D Molecular Therapeutics reports Q2 2025 financial results • $417mln in cash, cash equivalents, and marketable securities as of June 30, 2025 • Expected to fund operations into 2028 • 4D-150 Phase 3 program in wet AMD advancing ahead of plan • Expected 4FRONT-1 data readout accelerated to H1 2027 from H2 2027 • 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.
4D Molecular Therapeutics (4DMT), a leading late-stage biotechnology company, has reported its Q2 2025 financial results, highlighting significant advancements in its 4D-150 Phase 3 program for wet age-related macular degeneration (AMD) and diabetic macular edema (DME).Financial Highlights:
- Cash Position: As of June 30, 2025, 4DMT reported $417 million in cash, cash equivalents, and marketable securities, down from $505 million as of December 31, 2024. The company expects this cash to fund planned operations into 2028 [1].
- Research and Development Expenses: R&D expenses for the second quarter of 2025 were $48.0 million, up from $31.9 million in the same period last year. This increase was primarily driven by the initiation of the first Phase 3 clinical trial of 4D-150 in wet AMD [1].
- General and Administrative Expenses: G&A expenses were $11.5 million for the second quarter of 2025, up from $10.6 million in the same period last year, primarily due to increased use of professional services [1].
- Net Loss: The company reported a net loss of $54.7 million for the second quarter of 2025, compared to a net loss of $35.0 million in the same period last year [1].
Clinical Milestones:
- 4D-150 Program: The 4D-150 Phase 3 program for wet AMD is advancing ahead of plan. The topline data readout for 4FRONT-1, the North American Phase 3 clinical trial, has been accelerated to the first half of 2027 from the previous guidance of the second half of 2027. Additionally, 4FRONT-2, the second Phase 3 trial, was initiated in June 2025, ahead of schedule [1].
- SPECTRA Clinical Trial: 4DMT presented positive 60-week results from the SPECTRA clinical trial in DME, demonstrating strong clinical activity and sustained durability. The trial continues to support favorable tolerability and treatment burden reduction [1].
- Pulmonology Program: The company completed enrollment of Cohort 4 in the Phase 1 stage of the AEROW clinical trial for 4D-710, a genetic medicine for cystic fibrosis lung disease. Interim data from this trial and program updates are expected in Q4 2025 [1].
Operational Updates:
- Streamlined Organization: 4DMT announced a workforce reduction of approximately 25% of current and planned roles in July 2025, primarily in early-stage research and development and support functions. This 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 BLA preparation [1].
- Regulatory Alignment: Both the FDA and the European Medicines Agency (EMA) have aligned that a single successful Phase 3 study could support approval in the U.S. and Europe for 4D-150 in DME. The company has received RMAT designation from the FDA for 4D-150 for the treatment of DME [1].
Conclusion:
4D Molecular Therapeutics' Q2 2025 financial results reflect the company's continued focus on advancing its 4D-150 program and streamlining operations to drive late-stage execution. The company's strong cash position and operational efficiency position it well to continue its clinical development efforts through 2028.
References:
[1] https://www.marketscreener.com/news/4dmt-reports-second-quarter-2025-financial-results-operational-highlights-and-expected-upcoming-mil-ce7c5ed2df81f020
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