• Interim data to be presented in an oral presentation by Dr. Arshad M. Khanani, M.D., M.A., FASRS at the 2023 ARVO Annual Meeting on Thursday, April 27, 2023 at 11:30 a.m. ET
  
• Promoted Robert Kim, M.D. from SVP to Chief Medical Officer and Therapeutic Head, Ophthalmology
• Company to host live webcast on Thursday, April 27, 2023 at 8:00 a.m. ET

EMERYVILLE, Calif., April 13, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced an oral presentation of interim data from the 4D-150 Phase 1/2 PRISM clinical trial for wet age-related macular degeneration (wet AMD) at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held April 23-27, 2023 in New Orleans, Louisiana. 4D-150 is designed for single, low-dose intravitreal delivery of a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi and is currently in clinical development for wet AMD and diabetic macular edema (DME).

Interim data from Phase 1 cohorts (n=3 dose cohorts; N=15 patients) of the 4D-150 Phase 1/2 PRISM clinical trial for wet AMD will be presented in an oral presentation by Arshad M Khanani, M.D., M.A., FASRS, Managing Partner and Director of Clinical Research at Sierra Eye Associates, Clinical Associate Professor at University of Nevada, Reno, and a Principal Investigator in the 4D-150 PRISM clinical trial. The Company will host a live webcast on Thursday, April 27, 2023 at 8:00 a.m. ET to discuss the interim Phase 1 cohort clinical data and provide a program update.

In addition, 4DMT announced the promotion of Robert (Bob) Kim, M.D. to Chief Medical Officer, further supporting 4DMT’s strategy of becoming a fully integrated large market genetic medicines company with an expanding pipeline of product candidates for large market ophthalmologic diseases.

“I am thrilled to promote Bob to our Executive Team as we continue to advance each of our five product candidates in clinical development and enhance our genetic medicine platform,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “Bob’s extensive experience and leadership in the biotechnology industry, clinical research and development, deep knowledge as an educator and clinician within ophthalmology, and dedication to 4DMT’s mission will further boost the incredible productivity of the 4DMT genetic medicines product engine for sustainable large-market diseases. Bob previously played leadership roles within ophthalmology R&D at impactful companies including Genentech, Novartis, Apellis, and GSK, and as a faculty member at the University of California, San Francisco Medical School. Finally, we thank Dr. Robert Fishman for his commitment to 4DMT through an era of robust growth of our product pipeline, and we look forward to continuing to work with him in his new role as a valued Senior Advisor to our Lung Therapeutic Area team.”

Webcast Information:

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

2023 ARVO Annual Meeting Oral Presentation Details:

The presentation from 2023 ARVO Annual Meeting will also be available on the 4D Molecular Therapeutics website under Scientific Presentations: https://4dmoleculartherapeutics.com/technology/scientific-presentations.

About 4D-150 and Wet AMD and DME

4D-150 is comprised of our customized and evolved intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi. This dual transgene payload inhibits 4 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 created this platform utilizing principles of directed evolution, a Nobel Prize-winning technology. 4D-150 is designed for single, low-dose intravitreal delivery.

Wet AMD is a highly prevalent disease with estimated incidence rate of 200,000 new patients per year in the United States. 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.

DME is a highly prevalent disease with significant unmet medical need. It is estimated that there are approximately one million individuals with DME in the United States. DME is characterized by swelling in the macula (central retina) due to leakage from blood vessels. This can lead to blurred vision. DME is typically treated with intravitreal anti-VEGF agents administered approximately every 4-12 weeks.

About 4DMT

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases. 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 (Fabry disease cardiomyopathy). 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.

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, as well as the plans and related timing for the clinical development of 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 Annual Report on Form 10-K, 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:

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Investors:

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