FDMT 4D Molecular Therapeutics Inc

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 host a 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET.

The 4D-150 Wet AMD Development Day agenda will feature presentations, KOL panel discussions and live Q&A with senior ophthalmology Company leadership, including Robert Kim, M.D. (Chief Medical Officer), Dhaval Desai, Pharm.D. (Chief Development Officer), Chris Simms (Chief Commercial Officer) and Carlos Quezada-Ruiz, M.D., FASRS (SVP, Therapeutic Area Head, Ophthalmology) and retinal disease KOLs Arshad M. Khanani, M.D., M.A., FASRS (Sierra Eye Associates), Carl D. Regillo, M.D., FACS, FASRS (Wills Eye Hospital) and Dante Pieramici, M.D. (California Retina Consultants).

The agenda will include presentations on:

• Overview of 4D-150 Phase 1/2 Development Strategy in Wet AMD to Date (PRISM Clinical Trial):
  • Rationale for clinical trial design and treatment cohorts
  • Phase 1/2a Study Design (Dose Exploration / Expansion cohorts)
    • Primary Objectives: Demonstrate safety profile, evidence of biological activity and selection of Phase 2b doses
    • Patient Population: Severe disease activity, high treatment burden (minimum 6 prior injections in last 12 months) and generally long disease duration
    • Aflibercept loading dose regimen design: Given heavy pre-treatment of patients on study, single loading dose given at Week -1
  • Phase 2b Study Design (Population Extension cohort)
    • Primary Objective: Confirm safety & evidence of biological activity in broad patient population, select Phase 3 dose and patient population to maximize probability of technical, regulatory and commercial success
    • Patient Population: Broad range of disease activity, prior treatment burden (1 to 6 prior injections in last 12 months) and disease duration
    • Aflibercept loading dose design: Given only 1 prior injection required, loading doses given at weeks -1 & 4 to ensure all patients receive 3 total loading injections per standard of care, and to maintain patient safety during ramp up of aflibercept transgene expression over 8-12 weeks

• Expected Data Presentation & Analyses:
  • Presentation of interim longest available follow-up data for below cohorts and dose levels from PRISM based on August 26, 2024 data cutoff
    • Follow-up Duration
      • Phase 1/2a (Dose Exploration / Expansion cohorts; 6E9, 1E10 and 3E10 vg/eye of 4D-150 and aflibercept control arms), range of follow-up: 52 weeks to 2.5 years
      • Phase 2b (Population Extension cohort; 1E10 and 3E10 vg/eye arms), range of follow-up: 32 to 52 weeks
    • Efficacy Data
      • Supplemental aflibercept injections
      • Best Corrected Visual Acuity (BCVA)
      • Central Subfield Thickness (CST)
      • Subgroup analyses based on:
        • CST <600 μm
        • Disease duration
        • Number of prior injections
        • Approximate target Phase 3 population
    • Safety Data
• Review of 4FRONT Wet AMD Phase 3 Program Objectives, Strategy and Final Design

About the KOL Panelists

• Arshad M. Khanani, M.D., M.A., FASRS, is a Managing Partner, Director of Clinical Research and Director of Fellowship at Sierra Eye Associates, and Clinical Professor at the University of Nevada, Reno School of Medicine. He has served as the principal investigator for more than 120 clinical trials and has over 150 scientific publications. Dr. Khanani is an elected member of the Macula Society and Retina Society. He has received numerous awards of distinction including the prestigious American Society of Retina Specialists (ASRS) Presidents’ Young Investigator Award and the ASRS Presidential Award. He is the lead Principal Investigator of the 4D-150 PRISM clinical trial and the Chair of 4DMT’s Ophthalmology Advisory Board.

• Carl D. Regillo, M.D., FACS, FASRS, is the Director of the Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia. He is the founder and former Director of the Wills Eye Clinical Retina Research Unit, former Chairman of the American Academy of Ophthalmology Retina Basic and Clinical Science Course, former Chairman of the Wills Eye Institutional Review Board, and prior Director of the Wills Eye Retina Fellowship. Dr. Regillo has authored over 200 publications along with over 50 book chapters and nine major books. He has been an investigator on numerous major clinical trials developing new treatments for retinal disorders such as macular degeneration and diabetic retinopathy. He lectures worldwide and has served on the scientific editorial board for numerous publications.

• Dante Pieramici, M.D., is a Managing Partner at California Retina Consultants, President of the California Retina Research Foundation, a member of the Medical Leadership Board of the Retina Consultants of America. Currently, he is the Medical Director of Clinical Research at California Retina Consultants. Dr. Pieramici has served as the principal, sub, reading center investigator or advisor for over 100 clinical trials. His research has focused primarily on new surgical and pharmacologic treatments for age-related macular degeneration and diabetic-related eye diseases. He is a Principal Investigator of the 4D-150 PRISM clinical trial and member of 4DMT’s Ophthalmology Advisory Board.

4D-150 Wet AMD Development Day Webcast Details

Title:	4D-150 Wet AMD Development Day
Date/Time:	Wednesday, September 18, 2024 from 4:15 p.m. to 6:15 p.m. ET
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 4DMT

4DMT is a leading clinical-stage genetic medicines 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 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 wholly owned and partnered product candidates. Our product design, development, and manufacturing engine helps us efficiently create and advance our diverse product pipeline with the goal of revolutionizing medicine with potential curative therapies for millions of patients. Currently, 4DMT is advancing six clinical-stage and one preclinical product candidate, each tailored to address rare and large market diseases in ophthalmology, pulmonology and cardiology. In addition, 4DMT is also advancing programs in CNS through a gene editing partnership. 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 (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.

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 and regulatory interactions regarding 4D-150. 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.

Contacts:

Media:

Katherine SmithInizio Evoke CommsMedia@4DMT.com

Investors:

Julian PeiHead of Investor Relations and Corporate FinanceInvestor.Relations@4DMT.com