4DMT to Present Interim Data from Aerosolized 4D-710 Phase 1/2 AEROW Clinical Trial for Cystic Fibrosis at 47ᵗʰ European Cystic Fibrosis Conference

Rhea-AI Summary

4D Molecular Therapeutics (Nasdaq: FDMT) will present interim data from the Phase 1/2 AEROW clinical trial of aerosolized 4D-710 for cystic fibrosis lung disease at the 47th European Cystic Fibrosis Conference on June 6, 2024. Dr. Jennifer L. Taylor-Cousar will present the data at 5:00 p.m. BST. The company will also host a webcast to discuss the data and provide a program update on the same day at 8:00 a.m. ET.

The presentation, titled 'CFTR transgene expression in airway epithelial cells following aerosolized administration of the AAV-based gene therapy 4D-710 to adults with cystic fibrosis lung disease,' will be part of the session 'Where are we with new therapeutic approaches?'

The webcast will be archived on the 4DMT website for one year.

Positive

• 4DMT is progressing with its 4D-710 gene therapy for cystic fibrosis lung disease, now in Phase 1/2.
• Interim data will be presented at a major conference, indicating forward momentum in clinical trials.
• The presentation and webcast provide transparency and keep investors informed.

Negative

• The outcome of the interim data presentation is uncertain and could impact stock performance.
• Phase 1/2 trials are early-stage, implying that the product is still far from market approval.
• Future funding needs may arise if the trial progresses, potentially diluting shareholder value.

• Interim clinical data will be presented by Jennifer L. Taylor-Cousar, M.D., Principal Investigator of the AEROW clinical trial at the 47^th European Cystic Fibrosis Conference on Thursday, June 6, 2024 at 5:00 p.m. BST
• Company to host webcast on Thursday, June 6, 2024 at 8:00 a.m. ET

EMERYVILLE, Calif., May 30, 2024 (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 interim data from the Phase 1/2 AEROW clinical trial evaluating aerosolized 4D-710 for treatment of cystic fibrosis lung disease will be presented at the 47^th European Cystic Fibrosis Conference, taking place in Glasgow, UK. The Company will host a webcast to discuss the data in detail and provide a program update on Thursday, June 6 at 8:00 a.m. ET.

47^th European Cystic Fibrosis Conference Presentation Details:

Title:	CFTR transgene expression in airway epithelial cells following aerosolized administration of the AAV-based gene therapy 4D-710 to adults with cystic fibrosis lung disease
Session:	WS06 – Where are we with new therapeutic approaches?
Date/Time:	Thursday, June 6, 2024 (5:00 to 5:15 p.m. BST)
Presenter:	Jennifer L. Taylor-Cousar, M.D., National Jewish Health

The presentation from the 47^th European Cystic Fibrosis Conference will also be available on the 4DMT website:
https://4dmoleculartherapeutics.com/pipeline/#posters-and-publications

Corporate Webcast Details:

Title:	4D-710 Phase 1/2 AEROW Interim Clinical Data & Program Update
Date/Time:	Thursday, June 6, 2024 at 8:00 a.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 at the following link: https://ir.4dmoleculartherapeutics.com/events.

About Cystic Fibrosis Lung Disease

Cystic fibrosis (CF) is an inherited progressive disease caused by mutations in the CFTR gene. It affects the lungs, pancreas and other organs. According to the Cystic Fibrosis Foundation, nearly 40,000 people in the United States and more than 105,000 people worldwide are living with CF, with approximately 1,000 new cases of CF diagnosed in the United States each year. Lung disease is the leading cause of morbidity and mortality in people with CF. CF causes impaired lung function, inflammation and bronchiectasis and is commonly associated with persistent lung infections and repeated exacerbations due to the inability to clear thickened mucus from the lungs. People with CF require lifelong treatment with multiple daily medications. The complications of the disease result in progressive loss of lung function, increasing need for IV antibiotics and hospitalizations, and ultimately lead to end-stage respiratory failure.

About 4D-710

4D-710 is comprised of our targeted and evolved next generation AAV vector, A101, and a codon-optimized CFTR∆R transgene. 4D-710 has the potential to treat a broad range of people with CF, independent of the specific CFTR mutation, and is designed for aerosol delivery to achieve targeted CFTR expression within lung airway epithelial cells. 4D-710 is being initially developed for the approximately 15% of people with CF whose disease is not amenable to existing CFTR modulator medicines (based on variant-eligibility and/or drug intolerance). In people with CFTR variants that are amenable to modulator medicines, the improvement in lung function is variable and often incomplete. We therefore expect to potentially develop 4D-710 for use in this broader population, either as a single agent and/or in combination with CFTR modulator medicines. 4D-710 has received the Rare Pediatric Disease Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA).

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 help 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 five clinical-stage and two preclinical product candidates, 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®, 4D®, 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.

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 4DMT’s product candidates, as well as the plans, announcements and related timing for the clinical development of 4D-710. 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 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 Smith
Inizio Evoke Comms
Katherine.Smith@inizioevoke.com

Investors:

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

FAQ

What is the focus of the 4DMT Phase 1/2 AEROW clinical trial?

The trial is evaluating aerosolized 4D-710 for the treatment of cystic fibrosis lung disease.

When will 4DMT present the interim data for 4D-710?

The interim data will be presented on June 6, 2024, at 5:00 p.m. BST.

Who will present the interim data for 4D-710 at the European Cystic Fibrosis Conference?

Dr. Jennifer L. Taylor-Cousar, the Principal Investigator, will present the data.

What is the title of the 4DMT presentation at the European Cystic Fibrosis Conference?

The title is 'CFTR transgene expression in airway epithelial cells following aerosolized administration of the AAV-based gene therapy 4D-710 to adults with cystic fibrosis lung disease.'

How can investors access the webcast for the 4D-710 interim data presentation?

Investors can access the webcast through the 4DMT website, and it will be archived for one year.