4DMT Announces Leadership Expansion with Proven Late-Stage Executives to Drive 4D-150 Execution and BLA Readiness

Rhea-AI Summary

4D Molecular Therapeutics (NASDAQ: FDMT) announced key leadership changes to strengthen its late-stage clinical development capabilities. Dr. Julie Clark has been promoted to Chief Medical Officer, bringing over 20 years of retina and clinical development experience, including involvement in 10 BLA-enabling studies and six Phase 3 trials. The company also welcomed Dr. Liansheng Zhu as SVP of Biometrics and Data Quality.

The company's 4FRONT-1 Phase 3 trial for 4D-150 is progressing ahead of schedule, with enrollment completion expected in Q1 2026. Additionally, FDMT has added distinguished retina industry advisors, including Glenn P. Sblendorio, Dr. Cal Roberts, and Dr. Wiley A. Chambers, to enhance their development and commercialization expertise. Dr. Robert Kim has stepped down as Chief Medical Officer.

Positive

• Accelerated enrollment in 4FRONT-1 Phase 3 trial, with completion expected in Q1 2026
• Addition of highly experienced executives with proven track records in BLA submissions and approvals
• Strengthened advisory team with distinguished retina industry leaders
• New CMO brings experience from 10 BLA-enabling studies and six Phase 3 trials

Negative

• Departure of Chief Medical Officer Dr. Robert Kim

Insights

Biotechnology Investment Analyst

4DMT strengthens leadership with experienced executives for 4D-150 Phase 3 trials, accelerating BLA timeline and commercial preparation.

4D Molecular Therapeutics has made strategic leadership changes that signal a significant progression toward late-stage clinical execution and commercialization readiness. The promotion of Julie Clark, M.D., to Chief Medical Officer represents a calculated move to accelerate the company's BLA timeline for 4D-150, their lead candidate for retinal vascular diseases. Dr. Clark brings exceptional credentials with experience across 10 BLA-enabling studies and leadership roles in multiple successful ophthalmic drug approvals including EYLEA®, JETREA®, BEOVU®, and IZERVAY®.

The addition of Liansheng Zhu, Ph.D., as SVP of Biometrics and Data Quality further strengthens 4DMT's regulatory capabilities. Dr. Zhu's extensive experience with FDA and EMA approvals for ophthalmic products like LUCENTIS®, BEOVU®, and IZERVAY® complements the company's strategic focus on data integrity and submission readiness.

Particularly encouraging is the company's disclosure that enrollment in the 4FRONT-1 Phase 3 trial is exceeding expectations, with completion now anticipated in Q1 2026. This accelerated timeline suggests strong investigator interest and patient demand for 4D-150, potentially shortening the path to market.

The assembly of distinguished retina industry advisors including former Iveric Bio CEO Glenn Sblendorio and former FDA Division of Ophthalmology Director Wiley Chambers adds valuable regulatory and commercial expertise. This advisory team appears strategically constructed to navigate the final stages of development and prepare for commercial launch.

These leadership changes collectively indicate 4DMT is transitioning from a clinical-stage to a commercial-ready organization, with focused execution on their lead asset in wet AMD and diabetic macular edema—both substantial market opportunities in ophthalmology.

• Julie Clark, M.D., promoted to Chief Medical Officer
• Liansheng Zhu, Ph.D., joined as SVP, Biometrics and Data Quality
• 4FRONT-1 Phase 3 trial enrollment continues to exceed expectations, with enrollment completion now expected in Q1 2026
• Addition of distinguished retina industry advisors enhances global development and commercialization expertise

EMERYVILLE, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced senior leadership additions and changes that align with the Company’s focus on late-stage clinical trial and BLA execution and commercial readiness.

Leadership Expansion with Proven Late-Stage Executives to Drive 4D-150 Program Execution 

• Julie Clark, M.D., was promoted to Chief Medical Officer, bringing over 20 years of experience in retina and global clinical development, with a proven track record across 10 BLA-enabling studies, including six Phase 3 trials with leadership roles in approvals and commercialization for EYLEA®, JETREA®, BEOVU®, and IZERVAY®. She has held senior leadership roles at Novartis, Iveric Bio, Adverum, and Opthea, and played key roles in pivotal trial leadership, global regulatory strategy, and BLA filings. Notably, Dr. Clark led clinical development at Iveric Bio, where she was instrumental in the development and approval of IZERVAY®. Dr. Clark joined 4DMT earlier this summer as SVP, Clinical Research & Development to drive execution of the 4FRONT Phase 3 clinical trials and manage the retina Clinical Science team. Her promotion reflects 4DMT’s focus on late-stage trial execution, regulatory preparedness, and acceleration of BLA filing timelines. 
• Liansheng Zhu, Ph.D., joined as SVP, Biometrics and Data Quality, bringing nearly two decades of global experience in late-stage and post-approval clinical development. His expertise includes biostatistics, statistical programming, data science and Health Economics and Outcomes Research (HEOR). Dr. Zhu has led or contributed to multiple pivotal clinical trials and regulatory submissions resulting in timely FDA and EMA approvals, including for LUCENTIS®, BEOVU®, and IZERVAY®. Most recently, he served as SVP and Global Head of Biometrics at Ocular Therapeutix. Dr. Zhu’s addition strengthens the Company’s capabilities in biometrics, regulatory strategy, BLA submission and preparation, and clinical data quality oversight. 
• Robert (Bob) Kim, M.D., has stepped down from his role as Chief Medical Officer to pursue other opportunities, effective August 30, 2025. Dr. Kim joined 4DMT in October 2020 and served as the Therapeutic Area Head of Ophthalmology. As a physician-scientist with expertise in ophthalmology translational medicine and clinical development, he contributed to the advancement of the Company’s retinal gene therapy pipeline and product portfolio into and through early clinical development, including 4D-110, 4D-125, and 4D-175, and the advancement of 4D-150 into Phase 3 trials in wet age-related macular degeneration (wet AMD).
  

“It is my pleasure to announce Dr. Julie Clark as our new Chief Medical Officer. Dr. Clark brings a proven track record of leading multiple BLA submissions and executing ten BLA-enabling and six Phase 3 trials for wet AMD and geographic atrophy (GA) therapeutics. Her deep clinical and regulatory expertise is a tremendous asset as we accelerate our Phase 3 program in wet AMD,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “Alongside our Chief Development Officer Dhaval Desai and Chief Commercial Officer Chris Simms, Julie and Liansheng re-join a high-performing team that has delivered remarkable results together in the past, most recently at Iveric Bio. Their shared experience and complementary strengths will be instrumental as we advance 4D-150, our potential backbone therapy for large market retinal vascular diseases. Bolstered by continued enthusiasm for 4D-150 and strong Phase 3 leadership, we are confident that our 4FRONT-1 Phase 3 clinical trial is on track to complete enrollment in Q1 2026, bringing it one step closer to patients in need. I also want to express our sincere gratitude to Dr. Kim for his many contributions to the Company over the last five years.”

Added Senior Retina Leadership Advisors to Support Late-Stage Strategy 

As we accelerate the development of 4D-150, we are honored to add the expertise of accomplished and distinguished retina leaders who will provide guidance as we transition from a late-stage to a commercial-ready company.

• Glenn P. Sblendorio – Former President and CEO of Iveric Bio
• Cal Roberts, M.D. – Former CEO of Lighthouse Guild, Former Chief Medical Officer of Bausch + Lomb, Clinical Professor of Ophthalmology at Weill Cornell Medical Center
• Wiley A. Chambers, M.D. – Former Director of the Division of Ophthalmology, Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA)
  

“I’m honored to join 4DMT at such a pivotal time for the Company and take the helm on our promising 4D-150 late-stage programs in wet AMD and diabetic macular edema (DME). I’ve had the privilege of working with our exceptional 4DMT team the past few months, and I know firsthand the caliber, commitment, and passion they bring to advancing potentially transformative therapies,” said Julie Clark, M.D., Chief Medical Officer of 4DMT. “I look forward to continuing to work closely with this exceptional team to bring 4D-150 to patients as quickly and safely as possible.”

About 4DMT  

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT.  

All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s 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 expected timing for the enrollment completion of the Company’s 4FRONT-1 Phase 3 trial, clinical development of our product candidates, including 4D-150 and 4D-710, and the shared experience and complementary strengths, and the impact from the shared experience and complementary strengths of Dr. Clark and Dr. Zhu. 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 filed on August 11, 2025, 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:
Jenn Gordon
dna Communications
Media@4DMT.com

Investors:
Julian Pei
Head of Investor Relations and Strategic Finance
Investor.Relations@4DMT.com

FAQ

Who is the new Chief Medical Officer of 4D Molecular Therapeutics (FDMT)?

Dr. Julie Clark has been promoted to Chief Medical Officer, bringing over 20 years of experience in retina and global clinical development, with involvement in 10 BLA-enabling studies and six Phase 3 trials.

When will 4D Molecular Therapeutics complete enrollment for the 4FRONT-1 Phase 3 trial?

FDMT expects to complete enrollment for the 4FRONT-1 Phase 3 trial in Q1 2026, ahead of previous expectations.

What new advisors has 4D Molecular Therapeutics (FDMT) added to its team?

FDMT has added three distinguished advisors: Glenn P. Sblendorio (former Iveric Bio CEO), Dr. Cal Roberts (former Bausch + Lomb CMO), and Dr. Wiley A. Chambers (former FDA Division of Ophthalmology Director).

Who is the new SVP of Biometrics and Data Quality at 4D Molecular Therapeutics?

Dr. Liansheng Zhu has joined as SVP of Biometrics and Data Quality, bringing nearly two decades of experience in late-stage clinical development and contributions to multiple FDA and EMA approvals.

What is 4D-150 being developed for by 4D Molecular Therapeutics?

4D-150 is being developed as a potential backbone therapy for large market retinal vascular diseases, specifically for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).