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4DMT Announces Corporate Webcast to Review Interim 52-week Results from the Phase 2b Cohort of PRISM in a Broad Wet AMD Population

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4D Molecular Therapeutics (FDMT) has announced a corporate webcast to discuss interim 52-week results from the Phase 2b Population Extension cohort of the PRISM clinical trial, evaluating 4D-150 in wet age-related macular degeneration (wet AMD) patients.

The data will be presented at Angiogenesis, Exudation, and Degeneration 2025 on February 8, 2025, followed by a corporate webcast on February 10, 2025. The presentation will feature Principal Investigators Dr. Dante Pieramici and Dr. Veeral Sheth.

The webcast will cover key topics including: 52-week efficacy data for 3E10 vg/eye dose (N=30), Phase 2b recently diagnosed population data (N=15), long-term safety data (N=71), aqueous humor aflibercept protein level data, and additional details on 32-week interim data from SPECTRA Part 1 in diabetic macular edema.

4D Molecular Therapeutics (FDMT) ha annunciato un webcast aziendale per discutere i risultati intermedi a 52 settimane del coorte di estensione della popolazione della fase 2b dello studio clinico PRISM, che valuta il 4D-150 nei pazienti con degenerazione maculare legata all'età umida (wet AMD).

I dati saranno presentati ad Angiogenesi, Eccesso e Degenerazione 2025 il 8 febbraio 2025, seguiti da un webcast aziendale il 10 febbraio 2025. La presentazione avrà come protagonisti i Ricercatori Principali Dr. Dante Pieramici e Dr. Veeral Sheth.

Il webcast coprirà argomenti chiave tra cui: dati di efficacia a 52 settimane per la dose di 3E10 vg/occhio (N=30), dati della popolazione recentemente diagnosticata della fase 2b (N=15), dati di sicurezza a lungo termine (N=71), livelli di proteina aflibercept nel umore acqueo, e ulteriori dettagli sui dati intermedi a 32 settimane della Parte 1 di SPECTRA nei casi di edema maculare diabetico.

4D Molecular Therapeutics (FDMT) ha anunciado un webcast corporativo para discutir los resultados interinos de 52 semanas de la cohorte de extensión poblacional del ensayo clínico PRISM, evaluando el 4D-150 en pacientes con degeneración macular relacionada con la edad húmeda (wet AMD).

Los datos se presentarán en Angiogénesis, Exudación y Degeneración 2025 el 8 de febrero de 2025, seguido de un webcast corporativo el 10 de febrero de 2025. La presentación contará con los Investigadores Principales Dr. Dante Pieramici y Dr. Veeral Sheth.

El webcast cubrirá temas clave que incluyen: datos de eficacia a 52 semanas para la dosis de 3E10 vg/ojo (N=30), datos de población recientemente diagnosticada de la fase 2b (N=15), datos de seguridad a largo plazo (N=71), niveles de proteína aflibercept en el humor acuoso, y detalles adicionales sobre los datos interinos a 32 semanas de la Parte 1 de SPECTRA en edema macular diabético.

4D Molecular Therapeutics (FDMT)는 습성 연령 관련 황반색소 변성(wet AMD) 환자에서 4D-150을 평가하는 PRISM 임상 시험의 2b 단계 인구 확장 코호트에서의 52주 중간 결과에 대해 논의하기 위해 기업 웹캐스트를 발표했습니다.

이 데이터는 2025년 2월 8일 Angiogenesis, Exudation, and Degeneration 2025에서 발표될 예정이며, 2025년 2월 10일에는 기업 웹캐스트가 이어질 것입니다. 발표자는 주요 연구원인 Dr. Dante Pieramici와 Dr. Veeral Sheth입니다.

웹캐스트에서는 52주 효능 데이터(3E10 vg/eye 용량, N=30), 2b 단계 최근 진단된 인구 데이터(N=15), 장기 안전성 데이터(N=71), 수용체 내 aflibercept 단백질 수치 데이터, 그리고 당뇨성 황반부종의 SPECTRA 1부에서의 32주 중간 데이터에 대한 추가 세부사항이 포함될 것입니다.

4D Molecular Therapeutics (FDMT) a annoncé un webinaire d'entreprise pour discuter des résultats intermédiaires à 52 semaines de la cohorte d'extension de population de l'essai clinique PRISM, évaluant le 4D-150 chez des patients atteints de dégénérescence maculaire liée à l'âge humide (wet AMD).

Les données seront présentées lors de l'événement Angiogenèse, Exsudation et Dégénérescence 2025 le 8 février 2025, suivi d'un webinaire d'entreprise le 10 février 2025. La présentation sera animée par les Investigateurs Principaux Dr. Dante Pieramici et Dr. Veeral Sheth.

Le webinaire couvrira des sujets clés, y compris : données d'efficacité à 52 semaines pour la dose de 3E10 vg/œil (N=30), données de la population récemment diagnostiquée de la phase 2b (N=15), données de sécurité à long terme (N=71), niveaux de protéines d’aflibercept dans l'humeur aqueuse, et d'autres détails sur les données intermédiaires à 32 semaines de la Partie 1 de SPECTRA dans l'œdème maculaire diabétique.

4D Molecular Therapeutics (FDMT) hat ein Unternehmenswebcast angekündigt, um die interimistischen 52-Wochen-Ergebnisse aus der Phase-2b-Bevölkerungs-Erweiterungs-Kohorte der PRISM-Studie zu diskutieren, in der 4D-150 bei Patienten mit feuchter altersbedingter Makuladegeneration (feuchte AMD) bewertet wird.

Die Daten werden am 8. Februar 2025 bei Angiogenese, Exsudation und Degeneration 2025 präsentiert, gefolgt von einem Unternehmenswebcast am 10. Februar 2025. Die Präsentation wird von den Hauptuntersuchern Dr. Dante Pieramici und Dr. Veeral Sheth durchgeführt.

Der Webcast wird zentrale Themen behandeln, darunter: 52-Wochen-Effizienz-Daten für eine Dosis von 3E10 vg/Auge (N=30), Daten zur kürzlich diagnostizierten Bevölkerung der Phase 2b (N=15), Langzeitsicherheitsdaten (N=71), Daten zu den Aflibercept-Proteinspiegeln im Kammerwasser sowie weitere Einzelheiten zu den 32-Wochen-Zwischendaten aus dem SPECTRA-Teil 1 bei diabetischem Makulaödema.

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  • Initial interim 52-week results from Phase 2b Population Extension cohort of PRISM clinical trial to be presented by Dante Pieramici, M.D., a Principal Investigator in PRISM, at Angiogenesis, Exudation, and Degeneration 2025 on Saturday, February 8, 2025 at 2:20 p.m. ET
  • Company to host webcast on Monday, February 10, 2025 at 8:00 a.m. ET to discuss the 4D-150 interim data including recently diagnosed subgroup, which most resembles the Phase 3 4FRONT-1 and -2 patient populations

EMERYVILLE, Calif., Jan. 29, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that the Company will present the initial interim 52-week data from the Phase 2b Population Extension cohort of the PRISM clinical trial evaluating 4D-150 in a broad wet age-related macular degeneration (wet AMD) patient population at Angiogenesis, Exudation, and Degeneration 2025 being held virtually on February 8, 2025. The Company will host a webcast to discuss the PRISM interim data and additional analyses from the 4D-150 program in wet AMD and diabetic macular edema (DME) on Monday, February 10, 2025 at 8:00 a.m. ET. Dante Pieramici, M.D. and Veeral Sheth, M.D., MBA, FACS, FASRS, Principal Investigators in the PRISM clinical trial, will also present on the webcast and be available for Q&A.

Angiogenesis, Exudation, and Degeneration 2025 Presentation Details:

Title:Phase 2b Population Extension Cohort Evaluating 4D-150 in Neovascular Age-Related Macular Degeneration: 52-Week Results
Date/Time:Saturday, February 8, 2025 (2:20 – 2:30 p.m. ET)
Presenter:Dante Pieramici, M.D., California Retina Consultants, Santa Barbara, CA


The presentation will also be available on the 4DMT website: https://4dmoleculartherapeutics.com/pipeline/#posters-and-publications

Corporate Webcast Details

Title:4D-150 in Broad Wet AMD Population: Interim 52-week Data from Phase 2b & Program Durability Update for 3E10 vg/eye (Phase 3 Dose)
Date/Time:Monday, February 10, 2025 at 8:00 a.m. ET
KOL Panelists:
  • Dante Pieramici, M.D., California Retina Consultants, Santa Barbara, CA
  • Veeral Sheth, M.D., MBA, FACS, FASRS, University Retina and Macula Associates, Chicago, IL
Topics:
  • 52-week landmark interim efficacy data for 3E10 vg/eye (N=30, PRISM Phase 2b)
    • Phase 2b recently diagnosed population (N=15), which most resembles the Phase 3 4FRONT-1 and -2 patient populations
  • Best available long-term interim safety data of 3E10 vg/eye (N=71, all PRISM Phase 1/2 patients)
  • Longest available aqueous humor aflibercept protein level data from PRISM
  • Additional details on the 32-week interim data from SPECTRA Part 1 in DME following the data release on Jan 10, 2025
Registration:Link


An archived copy of the webcast will be available for up to one year by visiting the “Investors & Media” section of the 4DMT website: https://ir.4dmoleculartherapeutics.com/events.

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 our customized and evolved intravitreal vector, R100, which was invented at 4DMT through our 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 4DMT

4DMT is a late-stage biotechnology company focused on unlocking the full potential of genetic medicines to treat large market diseases in ophthalmology and pulmonology. 4DMT’s proprietary invention platform, Therapeutic Vector Evolution, combines the power of directed evolution with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors for use in our wholly owned and partnered product candidates. Our lead program 4D-150 is a potential backbone therapy that is designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) targeted to the retina with a single, safe, intravitreal injection. Our second core program is 4D-710, which is the first known genetic medicine to demonstrate, in the lungs of people with cystic fibrosis (CF), successful delivery and expression of the CFTR transgene and initial clinical activity signals after aerosol delivery of a gene therapy. 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 FDA 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.

Contacts:

Media:

Lena Glaser
Director of Corporate Communications
Media@4DMT.com

Investors:

Julian Pei
Head of Investor Relations and Corporate Finance
Investor.Relations@4DMT.com


FAQ

What are the key findings from FDMT's Phase 2b PRISM trial 52-week results?

The results will be presented on February 8, 2025, at the Angiogenesis conference and discussed in detail during a corporate webcast on February 10, 2025.

How many patients are included in FDMT's Phase 2b PRISM trial analysis?

The analysis includes 30 patients for the 3E10 vg/eye dose efficacy data, with 15 patients in the recently diagnosed population subset.

When will FDMT present the PRISM trial data for wet AMD treatment?

FDMT will present the data at Angiogenesis, Exudation, and Degeneration 2025 on February 8, 2025, at 2:20 p.m. ET, followed by a corporate webcast on February 10, 2025.

What is the total safety database size for FDMT's 3E10 vg/eye dose?

The long-term interim safety data includes 71 patients from all PRISM Phase 1/2 trials.

4D Molecular Therapeutics, Inc.

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