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4DMT to Present Interim 24 Week Data from Randomized Phase 2 PRISM Clinical Trial of 4D-150 in High Treatment Need Wet AMD Patients at Angiogenesis, Exudation, and Degeneration 2024 Conference

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4D Molecular Therapeutics (Nasdaq: FDMT) announced the presentation of initial interim landmark data analysis from the Phase 2 PRISM clinical trial at the Angiogenesis, Exudation, and Degeneration 2024 Conference. The data will be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the trial, on February 3, 2024. The trial focuses on 4D-150, a treatment for high need patients with neovascular age-related macular degeneration (nAMD). The company will also host a webcast to discuss the data and provide a program update for 4D-150.
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  • Initial interim landmark data analysis (N=50 at 24 Weeks) to be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial, on Saturday, February 3, 2024 at 4:20 p.m. ET

EMERYVILLE, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company with three novel, highly targeted next generation AAV vectors currently in the clinic, today announced that the initial interim landmark data analysis (24 weeks) from the randomized Dose Expansion stage (N=50) of the Phase 2 PRISM clinical trial in high anti-VEGF (vascular endothelial growth factor) treatment need (6-12 anti-VEGF injections in prior 12 months) wet AMD patients will be presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference being held virtually on February 3, 2024.

The Company will also host a webcast to discuss the data in detail and include a 4D-150 program update with details to be announced at a future date.

2024 Angiogenesis, Exudation, and Degeneration Presentation Details:

Title:First Interim Results (24 weeks) for the Randomized Phase 2 Dose Expansion Stage of the PRISM Clinical Trial of 4D-150 in High Need Patients with nAMD
Date/Time:Saturday, February 3, 2024 at 4:20 p.m. ET
Presenter:Arshad M. Khanani, M.D., M.A., FASRS, Director of Clinical Research at Sierra Eye Associates, Clinical Associate Professor at University of Nevada, Reno School of Medicine
  

The presentation from the Angiogenesis, Exudation, and Degeneration 2024 Conference will also be available on the 4D Molecular Therapeutics website under Scientific Presentations:
https://4dmoleculartherapeutics.com/pipeline/#posters-and-publications

About 4D-150 for Wet AMD

4D-150 comprises our customized and evolved intravitreal vector, R100, and a transgene cassette that expresses both aflibercept and a VEGF-C inhibitory RNAi. This dual-transgene payload inhibits four angiogenic factors that drive wet AMD and DME: VEGF A, B, C and PlGF. R100 was invented at 4DMT through our proprietary Therapeutic Vector Evolution platform; we invented this platform utilizing principles of directed evolution, a Nobel Prize-winning technology. 4D-150 is designed for single, low-dose intravitreal delivery for transgene expression from the retina without significant inflammation.

About Wet AMD

Wet AMD is a highly prevalent disease with estimated incidence rate of 200,000 new patients per year in the United States. It is estimated that the total prevalence of wet AMD in the major markets, including the U.S., EU (major markets), and Japan, is approximately 3.1 million individuals. Wet AMD is a type of macular degeneration where abnormal blood vessels (choroidal neovascularization or CNV) grow into the macula, the central area of the retina. As a consequence, CNV causes swelling and edema of the retina, bleeding and scarring, and causes visual distortion and reduced acuity. The proliferation and leakage of abnormal blood vessels is stimulated by VEGF. This process distorts and can potentially destroy central vision and may progress to blindness without treatment.

About 4DMT 

4DMT is a clinical-stage biotherapeutics company with three novel, highly targeted next generation AAV vectors currently in the clinic targeting multiple large market diseases in ophthalmology and pulmonology, plus other therapeutic areas. 4DMT seeks to unlock the full potential of genetic medicines using its proprietary invention platform, Therapeutic Vector Evolution, which combines the power of the Nobel Prize-winning technology, directed evolution, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors for use in our product candidates. All of our vectors are proprietary to 4DMT and were invented at 4DMT, including the vectors utilized in our clinical-stage and preclinical pipeline product candidates: R100, A101, and C102. The Company is initially focused on five clinical-stage product candidates in three therapeutic areas for both rare and large market diseases: ophthalmology, pulmonology, and cardiology. The 4DMT customized and evolved vectors were invented with the goal of being delivered at relatively low doses through clinically routine, well-tolerated, and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently advancing five product candidates in clinical development: 4D-150 for wet AMD and DME, 4D-710 for cystic fibrosis lung disease, 4D-310 for Fabry disease cardiomyopathy, 4D-125 for XLRP, and 4D-110 for choroideremia. The 4D preclinical product candidates in development are: 4D-175 for geographic atrophy and 4D-725 for AATLD. 

4D-150, 4D-710, 4D-310, 4D-125, and 4D-110 are our product candidates in clinical development and have not yet been approved for marketing by the US FDA or any other regulatory authority. No representation is made as to the safety or effectiveness of 4D-150, 4D-710, 4D-310, 4D-125, or 4D-110 for the therapeutic uses for which they are being studied. 

4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. 

Contacts:

Media:

Katherine Smith
Evoke Canale
Katherine.Smith@evokegroup.com

Investors:

Julian Pei
Head of Investor Relations and Corporate Communications
Investor.Relations@4DMT.com
267-644-5097


FAQ

What is the landmark data analysis being presented by 4D Molecular Therapeutics?

4D Molecular Therapeutics is presenting the initial interim landmark data analysis from the Phase 2 PRISM clinical trial at the Angiogenesis, Exudation, and Degeneration 2024 Conference.

Who is presenting the data at the conference?

The data will be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial.

What is the focus of the PRISM clinical trial?

The PRISM clinical trial focuses on 4D-150, a treatment for high need patients with neovascular age-related macular degeneration (nAMD).

When will the presentation take place?

The presentation will take place on Saturday, February 3, 2024 at 4:20 p.m. ET.

Will 4D Molecular Therapeutics provide a program update?

Yes, the company will host a webcast to discuss the data and provide a program update for 4D-150, with details to be announced at a future date.

4D Molecular Therapeutics, Inc.

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