4DMT Reports First Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones
4D Molecular Therapeutics (FDMT) reported Q1 2025 financial results and key operational updates. The company has enrolled first patients in its 4D-150 Phase 3 clinical trial (4FRONT-1) for wet AMD, with over 50 clinical sites active. A second Phase 3 trial (4FRONT-2) is expected to begin in Q3 2025, with topline data from both trials anticipated in H2 2027.
The company maintains a strong financial position with $458 million in cash and equivalents as of March 31, 2025, expected to fund operations into 2028. Q1 2025 saw a net loss of $48.0 million, with R&D expenses of $40.7 million and G&A expenses of $12.9 million.
Notable achievements include receiving RMAT designation for 4D-150 in DME and positive Phase 1/2 trial results showing an 83% reduction in injection burden for wet AMD patients. The company has focused its pipeline on core programs 4D-150 and 4D-710, while pausing several other programs to extend cash runway.
4D Molecular Therapeutics (FDMT) ha riportato i risultati finanziari del primo trimestre 2025 e aggiornamenti operativi chiave. L'azienda ha arruolato i primi pazienti nel suo studio clinico di Fase 3 4D-150 (4FRONT-1) per la degenerazione maculare umida (wet AMD), con oltre 50 siti clinici attivi. Un secondo studio di Fase 3 (4FRONT-2) è previsto per il terzo trimestre 2025, con dati principali attesi per la seconda metà del 2027.
L'azienda mantiene una solida posizione finanziaria con 458 milioni di dollari in contanti e equivalenti al 31 marzo 2025, sufficienti a finanziare le operazioni fino al 2028. Nel primo trimestre 2025 si è registrata una perdita netta di 48,0 milioni di dollari, con spese in R&S di 40,7 milioni e spese amministrative e generali di 12,9 milioni.
Tra i risultati rilevanti, l’ottenimento della designazione RMAT per 4D-150 nella DME e risultati positivi degli studi di Fase 1/2 che mostrano una riduzione dell’83% del carico di iniezioni per i pazienti con wet AMD. L’azienda ha concentrato il proprio portafoglio sui programmi principali 4D-150 e 4D-710, sospendendo diversi altri programmi per prolungare la disponibilità di cassa.
4D Molecular Therapeutics (FDMT) informó los resultados financieros del primer trimestre de 2025 y actualizaciones operativas clave. La compañía ha inscrito a los primeros pacientes en su ensayo clínico de fase 3 4D-150 (4FRONT-1) para la DMAE húmeda, con más de 50 sitios clínicos activos. Se espera que un segundo ensayo de fase 3 (4FRONT-2) comience en el tercer trimestre de 2025, con datos principales de ambos ensayos previstos para la segunda mitad de 2027.
La empresa mantiene una sólida posición financiera con 458 millones de dólares en efectivo y equivalentes al 31 de marzo de 2025, lo que se espera financie las operaciones hasta 2028. El primer trimestre de 2025 registró una pérdida neta de 48,0 millones de dólares, con gastos en I+D de 40,7 millones y gastos administrativos y generales de 12,9 millones.
Logros destacados incluyen la obtención de la designación RMAT para 4D-150 en DME y resultados positivos en los ensayos de fase 1/2 que muestran una reducción del 83% en la carga de inyecciones para pacientes con DMAE húmeda. La compañía ha enfocado su cartera en los programas principales 4D-150 y 4D-710, mientras pausa varios otros programas para extender la liquidez.
4D Molecular Therapeutics(FDMT)는 2025년 1분기 재무 결과 및 주요 운영 업데이트를 발표했습니다. 회사는 습성 황반변성(wet AMD)을 위한 4D-150 3상 임상시험(4FRONT-1)에 첫 환자를 등록했으며, 50개 이상의 임상 사이트가 활성화되어 있습니다. 두 번째 3상 시험(4FRONT-2)은 2025년 3분기에 시작될 예정이며, 두 시험의 주요 결과는 2027년 하반기에 발표될 예정입니다.
회사는 2025년 3월 31일 기준 4억 5,800만 달러의 현금 및 현금성 자산을 보유하고 있어 2028년까지 운영 자금을 확보할 것으로 예상됩니다. 2025년 1분기 순손실은 4,800만 달러였으며, 연구개발 비용은 4,070만 달러, 일반관리비는 1,290만 달러였습니다.
주요 성과로는 DME에 대한 4D-150의 RMAT 지정 획득과 습성 AMD 환자의 주사 부담을 83% 감소시킨 1/2상 임상시험의 긍정적인 결과가 포함됩니다. 회사는 핵심 프로그램인 4D-150과 4D-710에 파이프라인을 집중하고, 현금 유동성을 연장하기 위해 여러 다른 프로그램은 일시 중단했습니다.
4D Molecular Therapeutics (FDMT) a publié ses résultats financiers du premier trimestre 2025 ainsi que des mises à jour opérationnelles clés. La société a enrôlé les premiers patients dans son essai clinique de phase 3 4D-150 (4FRONT-1) pour la DML humide, avec plus de 50 sites cliniques actifs. Un second essai de phase 3 (4FRONT-2) devrait débuter au troisième trimestre 2025, avec des données principales attendues pour le second semestre 2027.
La société conserve une solide position financière avec 458 millions de dollars en liquidités et équivalents au 31 mars 2025, ce qui devrait financer ses opérations jusqu’en 2028. Le premier trimestre 2025 a enregistré une perte nette de 48,0 millions de dollars, avec des dépenses en R&D de 40,7 millions et des frais généraux et administratifs de 12,9 millions.
Parmi les réalisations notables, la désignation RMAT obtenue pour 4D-150 dans la DME et des résultats positifs des essais de phases 1/2 montrant une réduction de 83 % de la charge d’injections chez les patients atteints de DML humide. La société a recentré son portefeuille sur les programmes clés 4D-150 et 4D-710, tout en mettant en pause plusieurs autres programmes afin de prolonger sa trésorerie.
4D Molecular Therapeutics (FDMT) berichtete über die Finanzergebnisse des ersten Quartals 2025 und wichtige betriebliche Updates. Das Unternehmen hat die ersten Patienten in seiner Phase-3-Studie 4D-150 (4FRONT-1) für feuchte AMD eingeschlossen, mit über 50 aktiven Studienzentren. Eine zweite Phase-3-Studie (4FRONT-2) soll im dritten Quartal 2025 starten, wobei die wichtigsten Daten beider Studien für die zweite Hälfte 2027 erwartet werden.
Das Unternehmen befindet sich in einer starken finanziellen Lage mit 458 Millionen US-Dollar an liquiden Mitteln zum 31. März 2025, die voraussichtlich den Betrieb bis 2028 finanzieren werden. Im ersten Quartal 2025 wurde ein Nettoverlust von 48,0 Millionen US-Dollar verzeichnet, mit F&E-Ausgaben von 40,7 Millionen und Verwaltungs- und Gemeinkosten von 12,9 Millionen.
Bemerkenswerte Erfolge umfassen die RMAT-Zulassung für 4D-150 bei DME sowie positive Phase-1/2-Ergebnisse, die eine Reduktion der Injektionsbelastung um 83 % bei Patienten mit feuchter AMD zeigen. Das Unternehmen konzentriert seine Pipeline auf die Kernprogramme 4D-150 und 4D-710, während mehrere andere Programme pausiert wurden, um die Liquidität zu verlängern.
- Strong cash position of $458M expected to fund operations into 2028 without additional capital needs
- Positive Phase 1/2 trial results for 4D-150: 83% reduction in injection burden for wet AMD patients
- FDA alignment on single Phase 3 trial for DME indication, streamlining the approval pathway
- RMAT designation received for 4D-150 in DME, adding to previous RMAT and PRIME designations
- Strategic pipeline focus on core programs to extend cash runway
- Increased net loss to $48.0M in Q1 2025 from $32.4M in Q1 2024
- Higher R&D expenses at $40.7M vs $27.9M year-over-year
- Multiple programs paused or terminated, including 4D-175, 4D-725, and 4D-310
- Phase 3 trial results not expected until H2 2027
Insights
4DMT advances to Phase 3 with strong clinical data and cash runway through Phase 3 readouts without needing additional financing.
4D Molecular Therapeutics has successfully transitioned to late-stage development with the initiation of its first Phase 3 trial (4FRONT-1) for its lead candidate 4D-150 in wet AMD. This represents a critical derisking milestone in the company's evolution, with the second Phase 3 trial (4FRONT-2) expected to begin in Q3 2025.
The company's financial position is solid with
The Phase 2 data supporting the Phase 3 program is compelling. At the Phase 3 dose, 4D-150 demonstrated an
Similar efficacy was observed in diabetic macular edema with meaningful vision gains (+8.4 letters) and an
The FDA has granted Regenerative Medicine Advanced Therapy designation for 4D-150 in DME, complementing earlier RMAT and PRIME designations in wet AMD. These regulatory advantages could potentially accelerate development timelines.
The strategic pipeline prioritization to focus resources on 4D-150 (ophthalmology) and 4D-710 (cystic fibrosis), while pausing earlier programs, reflects disciplined capital allocation. R&D expenses increased to
- Enrolled first patients in first 4D-150 Phase 3 clinical trial (4FRONT-1) in wet AMD, with over 50 clinical trial sites open to date
- Initiation of second 4D-150 Phase 3 clinical trial (4FRONT-2) expected in Q3 2025, with topline data from both 4FRONT-1 and 4FRONT-2 expected in H2 2027
- RMAT designation received from FDA for 4D-150 in DME, adding to previous regulatory designations of RMAT and PRIME (EMA) for 4D-150 in wet AMD
$458 million in cash, cash equivalents, and marketable securities as of March 31, 2025, expected to fund planned operations into 2028
EMERYVILLE, Calif., May 08, 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 Q1 2025 financial results, provided operational highlights and outlined expected upcoming milestones.
“The first quarter of 2025 marked a pivotal moment for 4DMT as we focused our pipeline on our highest value programs, 4D-150 and 4D-710, reported compelling 4D-150 Phase 2 results in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and initiated our first 4D-150 Phase 3 clinical trial 4FRONT-1 in wet AMD,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “With strong Phase 1/2 data, optimized Phase 3 trial design, and a world-class leadership team, we are well positioned to execute on our mission to dramatically improve lives and outcomes for patients living with retinal vascular diseases with 4D-150, a backbone therapy designed to provide long-lasting relief from frequent and burdensome injections. Our strong balance sheet provides us an expected operational runway into 2028, enabling us to deliver topline results from both wet AMD Phase 3 clinical trials in H2 2027 without raising additional capital. We look forward to sharing data and programmatic updates in H2 2025 for both our 4D-150 program in wet AMD and DME and our 4D-710 program in cystic fibrosis lung disease.”
Recent Corporate Highlights
- Focused Pipeline and Extended Cash Runway
- Identified core programs: 4D-150 for wet AMD and DME and 4D-710 for cystic fibrosis (CF) lung disease
- Paused significant additional capital allocation and investment, pending additional financing or partnerships, for 4D-175 for geographic atrophy, 4D-725 for alpha-1 antitrypsin deficiency lung disease, and 4D-310 for Fabry disease cardiomyopathy
- Terminated development of 4D-110 for choroideremia and 4D-125 for X-linked retinitis pigmentosa
- Paused investment into new preclinical product candidates
- As a result, cash runway was extended into 2028 and includes full execution and topline 52-week data from 4FRONT-1 and 4FRONT-2 Phase 3 clinical trials in wet AMD, as well as ongoing Phase 1 & 2 clinical development of 4D-150 in DME and 4D-710 in CF
Recent Highlights and Expected Milestones in Large Market Ophthalmology Portfolio
- 4D-150 for wet AMD:
- 4FRONT Global Phase 3 Program:
- Enrolled first patients in North American clinical trial, 4FRONT-1
- Global clinical trial, 4FRONT-2, expected to initiate in Q3 2025
- Primary endpoint 52-week topline data from both 4FRONT-1 and 4FRONT-2 expected in H2 2027
- PRISM Phase 1/2 Clinical Trial:
- Presented positive 52-week results from 3E10 vg/eye (Phase 3 dose) arm of Phase 2b Population Extension cohort (best available data as of January 15, 2025):
- In the broad population (n=30), 3E10 vg/eye demonstrated
83% reduction in injection burden vs. projected on-label aflibercept 2 mg Q8W;70% of patients required 0-1 supplemental injection and57% were injection-free - In the recently diagnosed subgroup (n=15), which most resembles the Phase 3 4FRONT-1 and 4FRONT-2 patient populations, 3E10 vg/eye demonstrated
94% reduction in injection burden vs. projected on-label aflibercept 2 mg Q8W;87% of patients required 0-1 supplemental injection and80% were injection-free - Improved and maintained best corrected visual acuity (BCVA) and central subfield thickness (CST) with fewer fluctuations
- 4D-150 continues to be well tolerated during up to three years of follow-up in all patients (n=71) treated with 3E10 vg/eye dose, with the highest 4D-150-related intraocular inflammation (SUN/NEI scales) observed as mild (1+) vitreous cells at a single timepoint in
2.8% (2 of 71) of patients
- In the broad population (n=30), 3E10 vg/eye demonstrated
- Presented biomarker data from patients treated with 3E10 vg/eye in Phase 1/2a and 2b cohorts supporting ongoing multi-year durability with stable aqueous humor aflibercept concentrations consistently within projected therapeutic range with up to two years of follow-up (best available data as of November 20, 2024)
- 2-year data from Phase 1/2a and 18-month data from Phase 2b cohorts expected in Q4 2025
- Presented positive 52-week results from 3E10 vg/eye (Phase 3 dose) arm of Phase 2b Population Extension cohort (best available data as of January 15, 2025):
- 4FRONT Global Phase 3 Program:
- 4D-150 for DME:
- SPECTRA Part 1 Clinical Trial:
- Presented positive interim 32-week data (data cutoff: December 13, 2024)
- Across all patients dosed to date, 4D-150 continues to be well-tolerated, with no intraocular inflammation observed at any timepoint or dose level
- Post-3 loading doses of aflibercept, 3E10 vg/eye demonstrated strong signals of clinical activity, with sustained gain of BCVA of +8.4 letters and reduction of CST of -194 µm from baseline
- 3E10 vg/eye achieved an
86% reduction in injection burden vs. projected on-label aflibercept 2 mg Q8W and dose response, with61% reduction vs. the lower-dose cohort at 1E10 vg/eye, with 0.6 mean supplemental injections per patient, with stringent supplemental injection criteria
- 52-week interim data update expected at a scientific conference in Q3 2025
- Presented positive interim 32-week data (data cutoff: December 13, 2024)
- Phase 3 Planning:
- Announced alignment with U.S. Food and Drug Administration (FDA) on registrational path
- FDA aligned with proposed single Phase 3 clinical trial being acceptable for the basis of a BLA submission for 4D-150 in DME, based on review of data from SPECTRA and PRISM (wet AMD) clinical trials to date and planned global Phase 3 clinical development program for wet AMD
- Per FDA feedback, the Company may proceed to Phase 3 (SPECTRA Part 2 no longer needed), and the FDA is aligned with key design elements of a Phase 3 clinical trial with approximately 300-400 patients total with a primary endpoint of BCVA noninferiority vs. on-label aflibercept 2 mg (5 loading doses and Q8W) and revised supplemental injection criteria
- Received Regenerative Medicine Advanced Therapy (RMAT) designation from FDA, validating 4D-150’s potential to address the significant unmet medical needs in treating DME
- Next steps pending final FDA and EMA alignment on Phase 3 clinical trial design and funding pathway
- Announced alignment with U.S. Food and Drug Administration (FDA) on registrational path
- SPECTRA Part 1 Clinical Trial:
Recent Highlights and Expected Milestones in Pulmonology Program
- 4D-710 for CF Lung Disease:
- Ongoing enrollment extension of three additional participants in Cohort 4 (target enrollment of n=6) of Phase 1 stage of AEROW clinical trial (target total enrollment of n=16 participants)
- Interim data from AEROW clinical trial and program update expected at a scientific conference in H2 2025
Q1 2025 Financial Results
Cash position: Cash, cash equivalents, and marketable securities were
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
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. Our 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. Our 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. Our 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 our 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 our 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 March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenue: | ||||||||
| Collaboration and license revenue | $ | 14 | $ | 28 | ||||
| Operating expenses: | ||||||||
| Research and development | 40,699 | 27,870 | ||||||
| General and administrative | 12,936 | 10,294 | ||||||
| Total operating expenses | 53,635 | 38,164 | ||||||
| Loss from operations | (53,621 | ) | (38,136 | ) | ||||
| Other income, net | 5,649 | 5,735 | ||||||
| Net loss | $ | (47,972 | ) | $ | (32,401 | ) | ||
| Net loss per share, basic and diluted | $ | (0.86 | ) | $ | (0.66 | ) | ||
| Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 55,744,047 | 49,271,984 | ||||||
| 4D Molecular Therapeutics, Inc. Balance Sheet Data (Unaudited) (in thousands) | ||||||||
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash, cash equivalents and marketable securities | $ | 458,441 | $ | 505,460 | ||||
| Total assets | 515,729 | 560,384 | ||||||
| Total liabilities | 46,006 | 49,778 | ||||||
| Accumulated deficit | (624,167 | ) | (576,195 | ) | ||||
| Total stockholders’ equity | 469,723 | 510,606 | ||||||
Contacts:
Media:
Jenn Gordon
dna Communications
Media@4DMT.com
Investors:
Julian Pei
Head of Investor Relations and Corporate Finance
Investor.Relations@4DMT.com
FAQ
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