4DMT Announces Accelerated 4D-150 Phase 3 Development in Wet AMD and Streamlined Organization to Drive Late-Stage Execution
4D Molecular Therapeutics (NASDAQ:FDMT) announced significant acceleration of its 4D-150 Phase 3 program for wet age-related macular degeneration (wet AMD). The 4FRONT-1 Phase 3 trial's topline data readout has been moved forward to H1 2027 from H2 2027, while the 4FRONT-2 Phase 3 trial was initiated ahead of schedule in June 2025.
The company implemented a 25% workforce reduction, primarily affecting early-stage R&D and support functions, expected to generate $15 million in annual cash savings. With $458 million in cash as of March 31, 2025, FDMT maintains its cash runway into 2028, supporting both Phase 3 trials, BLA preparation, and ongoing development programs in diabetic macular edema and cystic fibrosis.
4D Molecular Therapeutics (NASDAQ:FDMT) ha annunciato un'accelerazione significativa del suo programma 4D-150 di Fase 3 per la degenerazione maculare senile umida (wet AMD). La pubblicazione dei dati principali dello studio di Fase 3 4FRONT-1 è stata anticipata al primo semestre del 2027 rispetto al secondo semestre del 2027, mentre lo studio di Fase 3 4FRONT-2 è stato avviato in anticipo a giugno 2025.
L'azienda ha effettuato una riduzione del personale del 25%, che ha interessato principalmente la R&D in fase iniziale e le funzioni di supporto, con un risparmio annuo stimato di 15 milioni di dollari. Con 458 milioni di dollari in cassa al 31 marzo 2025, FDMT mantiene una liquidità sufficiente fino al 2028, supportando entrambi gli studi di Fase 3, la preparazione della BLA e i programmi di sviluppo in corso per l'edema maculare diabetico e la fibrosi cistica.
4D Molecular Therapeutics (NASDAQ:FDMT) anunció una aceleración significativa de su programa 4D-150 de Fase 3 para la degeneración macular húmeda relacionada con la edad (wet AMD). La publicación de los datos principales del ensayo de Fase 3 4FRONT-1 se adelantó al primer semestre de 2027 desde el segundo semestre de 2027, mientras que el ensayo de Fase 3 4FRONT-2 se inició antes de lo previsto en junio de 2025.
La compañía implementó una reducción del 25% en la plantilla, afectando principalmente a I+D en etapas tempranas y funciones de apoyo, con un ahorro anual esperado de 15 millones de dólares. Con 458 millones de dólares en efectivo al 31 de marzo de 2025, FDMT mantiene su liquidez hasta 2028, respaldando ambos ensayos de Fase 3, la preparación del BLA y los programas de desarrollo en curso para edema macular diabético y fibrosis quística.
4D Molecular Therapeutics (NASDAQ:FDMT)가 습성 연령 관련 황반변성(wet AMD) 치료를 위한 4D-150 3상 프로그램의 가속화를 발표했습니다. 4FRONT-1 3상 시험의 주요 데이터 발표 시점이 2027년 하반기에서 2027년 상반기로 앞당겨졌으며, 4FRONT-2 3상 시험은 2025년 6월 예정보다 조기 시작되었습니다.
회사는 주로 초기 연구개발 및 지원 부문에 영향을 미치는 인력 25% 감축을 시행했으며, 연간 1,500만 달러의 현금 절감 효과가 예상됩니다. 2025년 3월 31일 기준 4억 5,800만 달러의 현금 보유로 FDMT는 2028년까지 자금 운용이 가능하며, 두 3상 시험, BLA 준비, 당뇨병성 황반부종 및 낭포성 섬유증 개발 프로그램을 지원할 계획입니다.
4D Molecular Therapeutics (NASDAQ:FDMT) a annoncé une accélération significative de son programme de Phase 3 4D-150 pour la dégénérescence maculaire liée à l'âge humide (wet AMD). La publication des données principales de l'essai de Phase 3 4FRONT-1 a été avancée au premier semestre 2027 au lieu du second semestre 2027, tandis que l'essai de Phase 3 4FRONT-2 a été lancé en avance en juin 2025.
L'entreprise a procédé à une réduction de 25 % de ses effectifs, touchant principalement la R&D précoce et les fonctions de support, ce qui devrait générer une économie annuelle de 15 millions de dollars. Avec 458 millions de dollars en trésorerie au 31 mars 2025, FDMT dispose d'une trésorerie suffisante jusqu'en 2028, soutenant les deux essais de Phase 3, la préparation du BLA et les programmes de développement en cours pour l'œdème maculaire diabétique et la fibrose kystique.
4D Molecular Therapeutics (NASDAQ:FDMT) gab eine bedeutende Beschleunigung seines 4D-150 Phase-3-Programms für die feuchte altersbedingte Makuladegeneration (wet AMD) bekannt. Die Topline-Daten des Phase-3-Studie 4FRONT-1 wurden vom zweiten Halbjahr 2027 auf das erste Halbjahr 2027 vorgezogen, während die Phase-3-Studie 4FRONT-2 planmäßig im Juni 2025 gestartet wurde.
Das Unternehmen hat eine Personalreduzierung von 25 % umgesetzt, die hauptsächlich die frühe F&E und Supportfunktionen betrifft, und erwartet dadurch jährliche Kosteneinsparungen von 15 Millionen US-Dollar. Mit 458 Millionen US-Dollar an liquiden Mitteln zum 31. März 2025 verfügt FDMT über eine Finanzierungsbasis bis 2028, die sowohl die beiden Phase-3-Studien, die BLA-Vorbereitung als auch laufende Entwicklungsprogramme bei diabetischem Makulaödem und Mukoviszidose unterstützt.
- Acceleration of 4FRONT-1 Phase 3 trial data readout by 6 months to H1 2027
- Strong enrollment and site activation exceeding initial projections
- Early initiation of 4FRONT-2 Phase 3 trial in June 2025
- $15 million annual cash compensation cost savings from restructuring
- Robust cash position of $458 million as of March 31, 2025
- Cash runway extended into 2028
- 25% workforce reduction affecting early-stage R&D and support functions
- Reduction in early-stage research and development capabilities
Insights
4DMT accelerates wet AMD Phase 3 trials while restructuring operations, positioning for faster potential approval with sustained cash runway into 2028.
4D Molecular Therapeutics has made significant progress with its 4D-150 program for wet age-related macular degeneration (wet AMD), a leading cause of vision loss affecting millions of elderly patients. The company has accelerated the expected data readout for its 4FRONT-1 Phase 3 trial from H2 2027 to H1 2027, which represents a critical milestone that could potentially shorten the path to market by six months.
The acceleration stems from stronger-than-expected site activation and patient enrollment, indicating substantial investigator enthusiasm and patient interest in this novel therapy. This level of engagement suggests the clinical community recognizes the potential value proposition of 4D-150 based on its earlier Phase 1/2 data showing durable efficacy with reduced treatment burden – addressing what patients and physicians consistently identify as the greatest unmet need in wet AMD management.
Additionally, 4DMT has initiated its second Phase 3 trial (4FRONT-2) ahead of schedule, which broadens the patient population to include both treatment-naïve and recently treated patients. This expanded population approach is strategically important as it could support a wider label upon approval and increase market penetration.
The company has implemented a 25% workforce reduction, primarily affecting early-stage research and support functions, while preserving resources for late-stage clinical development. This strategic realignment is expected to yield annual savings of approximately
This clinical acceleration and organizational restructuring demonstrates the company's disciplined approach to capital allocation and commitment to bringing 4D-150 to market as efficiently as possible, potentially transforming the treatment paradigm for patients with retinal vascular diseases who currently require frequent intravitreal injections.
- 4FRONT-1 Phase 3 expected data readout accelerated from H2 2027 to H1 2027
- 4FRONT-2 Phase 3 trial initiated ahead of schedule
- Streamlined late-stage clinical and pre-commercial organization aligns with focused pipeline shift, as announced in January 2025
EMERYVILLE, Calif., July 02, 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 announced the acceleration of the 4D-150 4FRONT Phase 3 program in wet age-related macular degeneration (wet AMD). The Company also has streamlined operations to offset additional expenses expected based on the accelerated timelines for the 4FRONT clinical trials and BLA preparation, which supports the Company’s cash runway into 2028, as previously guided. The transition reflects the Company’s focus on its late-stage pipeline, a strategy previously announced in January 2025.
Company Streamlined to Drive Accelerated Phase 3 Development
- 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 are now expected in H1 2027, an acceleration of the timeline from the previous guidance of H2 2027, providing more than six months of expected cash runway beyond the expected data readout.
- The second Phase 3 trial of 4D-150 in wet AMD, 4FRONT-2, was initiated in June 2025, ahead of schedule. 4FRONT-2 is a global Phase 3 clinical trial of 4D-150 in wet AMD and has an identical design to 4FRONT-1 except for enrolling both treatment-naïve and recently diagnosed, treatment-experienced patients.
- 52-week topline data for 4FRONT-2 are expected in H2 2027, consistent with previous guidance.
- Implemented 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 BLA preparation, which supports the Company’s cash runway into 2028, as previously guided. - Total cash, cash equivalents, and marketable securities were
$458 million as of March 31, 2025, which the Company believes is sufficient to support planned expenses to deliver 52-week topline data from 4FRONT-1 and 4FRONT-2 Phase 3 clinical trials and BLA preparation for 4D-150 in wet AMD, continue Phase 1/2 and pre-Phase 3 planning activities for 4D-150 in diabetic macular edema (DME), and continue ongoing Phase 1/2 development of 4D-710 in cystic fibrosis (CF).
“We are thrilled with the strong interest in 4D-150 from investigators and patients in both 4FRONT Phase 3 studies, reflecting their belief in the Phase 1/2 data demonstrating the tolerability and robust, durable clinical activity of this potential foundational backbone therapy for retinal vascular diseases. This progress also confirms our belief that durable treatment burden reduction is the greatest unmet need for these patients. As a result, we now anticipate topline data for 4FRONT-1 in the first half of 2027,” said Dhaval Desai, Chief Development Officer of 4DMT.
“We have aligned our resources to deliver on our mission of bringing transformative and durable genetic medicines to millions of patients in need, with a focus on 4D-150 for wet AMD, in our ongoing transition to becoming a commercial company,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “I want to express my deep gratitude and respect for the talented colleagues whose work has been critical to 4DMT’s success to date, who we thank sincerely for their dedication to and passion for our mission.”
About 4D-150
4D-150 is a potential backbone therapy that is designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection. 4D-150 utilizes the Company’s customized and evolved intravitreal vector, R100, which was invented at 4DMT through the Company’s proprietary Therapeutic Vector Evolution platform. 4D-150 is being developed for wet AMD and DME, which both affect millions of patients globally, with the goal of freeing patients from burdensome injections while preserving vision.
About Wet AMD
Wet AMD is a highly prevalent disease, with more than 4 million individuals expected to be affected in the next five years in certain major markets, including the U.S., the EU and Japan. The disease also has a high incidence, with 200,000 individuals estimated to be newly diagnosed every year in the U.S. alone. Wet AMD is a type of macular degeneration in which abnormal blood vessels grow into the macula (macular neovascularization or MNV), the central area of the retina. MNV causes swelling and edema of the retina, bleeding and scarring, leading to visual distortion and reduced visual acuity. The proliferation and leakage of abnormal blood vessels is stimulated by VEGF. This process distorts and, without treatment, can potentially destroy central vision and may progress to blindness.
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 development plans for its product candidates, including 4D-150 and 4D-710, timing for the announcement of results from ongoing clinical trials, the approximate size of the workforce reduction, the expected cost savings to be provided by the workforce reduction, the sufficiency of capital resources to support planned expenses regarding ongoing clinical trials, and statements regarding the Company’s 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 filed on May 8, 2025 as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' current views and should not be relied upon as representing its views as of any subsequent time. 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 Communications
Media@4DMT.com
Investors:
Julian Pei
Head of Investor Relations and Corporate Finance
Investor.Relations@4DMT.com
FAQ
When will 4D Molecular Therapeutics (FDMT) report Phase 3 results for 4D-150 in wet AMD?
How much cash does FDMT have and how long will it last?
What is the impact of FDMT's workforce reduction announced in July 2025?
What are the differences between 4FRONT-1 and 4FRONT-2 trials for FDMT's 4D-150?
What programs is FDMT currently developing besides wet AMD?
