Press Release

4D Molecular Therapeutics Announces Preclinical Data Presentations at ASGCT and ATS Annual Meetings on Three Wholly-Owned Product Candidates from Non-Human Primate Studies

April 27, 2021

Abstracts on 4D-150 for wet AMD/DME and 4D-310 for Fabry disease accepted for oral presentations at ASGCT 24th Annual Meeting

Abstract on 4D-710 for cystic fibrosis lung disease accepted for oral presentation at ATS 2021 International Conference

EMERYVILLE, Calif., April 27, 2021 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage gene therapy company harnessing the power of directed evolution for targeted gene therapies, announced preclinical data presentations from non-human primate (NHP) studies at two upcoming medical meetings, the American Society for Gene and Cell Therapy (ASGCT) 24th Annual Meeting, held virtually from May 11 – 14 and the American Thoracic Society (ATS) 2021 International Conference, held virtually from May 14 – 19. The data presentations will address three of the company's wholly-owned product candidates leveraging three distinct targeted and evolved vectors across three therapeutic areas: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-310 for the treatment of Fabry disease and 4D-710 for the treatment of cystic fibrosis lung disease.

For the first-time, 4DMT will describe the design of 4D-150’s three distinct anti-angiogenic mechanisms and will present preclinical data demonstrating highly significant efficacy, durable aqueous anti-VEGF levels within the NHP eye, safety and tolerability in the laser-choroidal neovascularization (CNV) model.

Details for the presentations at each conference are as follows:

ASGCT 24th Annual Meeting
Abstracts are available online and presentations and posters will be accessible through ASGCT’s website at www.asgct.org.

Abstract Title: A Multi-Mechanistic Anti-Angiogenic AAV Gene Therapy Product Candidate, 4D-150, for the Treatment of Wet Age-Related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME): Intravitreal Biodistribution, Transgene Expression, Safety and Efficacy in Non-Human Primates
Session Type: Oral Presentation
Session Date/Time: Wednesday May 12, 2021 5:30 PM - 7:15 PM EDT
Session Title: AAV Biology, Engineering, Immunology and Animal Modeling
Abstract number: 64

Abstract Title: A Targeted AAV Gene Therapy Product Candidate, 4D-310, for the Treatment of Fabry Disease: Intravenous Biodistribution, Transgene Expression and Safety in Non-Human Primates
Session Type: Oral Presentation
Session Date/Time: Friday May 14, 2021 12:15 PM - 2:00 PM EDT
Session Title: Gene Therapy for Lysosomal Storage Disorders
Abstract number: 220

ATS 2021 Annual Conference
Abstracts are available online and presentations and posters will be accessible through ATS’s website at conference.thoracic.org.

Abstract Title: Identification and Characterization of a Novel AAV Capsid and Product for the Treatment of Cystic Fibrosis
Session Type: Mini Symposium (Oral)
Session Date/Time: Sunday May 16, 2021 1:30 PM - 3:00 PM EDT
Session Title: A010 Novel Discoveries in Lung Biology
Abstract number: A1043

Abstract Title: Development of Novel AAV-Based Gene Therapy for Cardiac Disease
Session Type: Thematic Poster Session
Session Date/Time: On Demand
Session Title: TP083 Hey Jude – Novel Findings from Omic and Bioinformatic approaches in Pulmonary Hypertension
Abstract Number: A3624

About 4DMT

4DMT is a clinical-stage company harnessing the power of directed evolution for targeted gene therapies. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered 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 conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP patients, 4D-110 is in a Phase 1 clinical trial for choroideremia patients and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease patients.

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

Cautionary Note Regarding 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 plans and timelines for the clinical development of 4D-310, 4D-125, 4D-110, 4D-150 and 4D-710, including the therapeutic potential and clinical benefits thereof; and 4DMT's strategy, business plans and focus. 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, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our clinical trials, strategy and future operations; the delay of any current or planned clinical trials for the development of 4DMT's drug candidates, the risk that the results of our clinical trials may not be predictive of future results in connection with future clinical trials; 4DMT's ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of our planned interactions with regulatory authorities; and obtaining, maintaining and protecting our intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in 4DMT’s most recent Annual Report on Form 10-K filed March 25, 2021, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4DMT's views only as of today and should not be relied upon as representing its views as of any subsequent date. 4DMT 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-310, 4D-125 and 4D-110 are our product candidates in clinical trials 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-310, 4D-125, or 4D-110 for the therapeutic use for which they are being studied.

Contacts:

Media:

Theresa Janke
tjanke@4dmt.com

Investors:

Mike Zanoni
Endurance Advisors
mzanoni@4dmt.com

 

 

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Source: 4D Molecular Therapeutics, Inc.