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