FDMT 4D Molecular Therapeutics Inc

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 strengthened the Company’s senior management team with the appointments of Dhaval Desai, PharmD, as Chief Development Officer, Christopher Simms as Chief Commercial Officer and Carlos Quezada-Ruiz, M.D., FASRS, as SVP, Therapeutic Area Head, Ophthalmology.

Dr. Desai will lead 4DMT’s late-stage Product Development, Medical Affairs, Scientific Communications, Regulatory and Quality operations. Mr. Simms will lead 4DMT’s Pre-commercial and Commercial organizations, effective September 25, 2024. Both Dr. Desai and Mr. Simms will join 4DMT’s Executive Team, reporting to David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. Dr. Quezada-Ruiz will lead the Ophthalmology franchise and oversee early- and late-stage ophthalmology clinical development, reporting to Bob Kim, M.D., Chief Medical Officer of 4DMT. With the addition of Dr. Desai, An Song, Ph.D., will transition from Chief Development Officer to Chief Research & Translational Development Officer.

“With the continued promise of 4D-150 as a pipeline-in-a-product, I am thrilled to have Dhaval, Chris and Carlos join the 4DMT team and bring their wealth of large market ophthalmology, regulatory, drug development and commercial experience to our company as we transition into Phase 3 development and pre-commercialization,” said Dr. Kirn. “Dhaval, Chris and Carlos’s leadership is vital to becoming a leading late-stage development genetic medicines company, with a focus on large market ophthalmic diseases. We believe the expansion of our senior leadership team with extensive ophthalmology experience will allow us to execute on our development objectives to design and rapidly enroll large global Phase 3 pivotal trials, and subsequently to make successful global regulatory submissions​.”

“It is a privilege to join 4DMT at this stage of rapid progress and to be able to focus my development expertise to bring these important product candidates to patients as effectively and efficiently as possible,” said Dr. Desai. “My experience working on pivotal Phase 3 programs and U.S. Food and Drug Administration (FDA) submissions in multiple large market retinal indications will complement the already stellar team that David and 4DMT have built. I look forward to collaborating and partnering with the entire 4DMT team to increase the strength of our ophthalmology portfolio, progress 4D-150 through late-stage development, and prepare for potential BLA submissions in the coming years.”

“Joining 4DMT at this time of growth is truly an incredible opportunity to contribute to the planning and potential introduction of transformational medicines in multiple large market ophthalmology indications like wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), diabetic retinopathy (DR) and geographic atrophy (GA),” said Mr. Simms. “I look forward to building a leading commercial strategy and infrastructure in support of late-stage development, registration and ultimately, commercialization. My experience in large market ophthalmology commercial strategy and execution helps fortify and bring 4DMT’s exceptional product pipeline of potentially paradigm shifting treatments to patients who need them most.”

“I am thrilled to join 4DMT and bring my drug development expertise, people and patient focus, to lead and further build 4DMT’s outstanding ophthalmology team ahead of the initiation of our first pivotal Phase 3 trial in wet AMD early next year, and to rapidly accelerate our development programs in additional large-market diseases including DME, DR and GA,” said Dr. Quezada-Ruiz. “As a medicines developer and practicing retina specialist, I am most excited about the potential of gene therapy to improve outcomes for our patients and believe that the greatest unmet need in treating wet AMD, DME, and now GA, is greater durability. Having played a leading role in the global development and approvals of VABYSMO and SUSVIMO, I have seen firsthand the positive impact that novel mechanisms of action and sustained durability have for patients, caregivers and physicians. Similarly, 4D-150’s potential to achieve sustained efficacy and extended durability should significantly reduce patients’ treatment burden while also maintaining vision through a safe, single intravitreally delivered gene therapy injection. I look forward to contributing to 4DMT’s mission to bring transformative genetic medicines to millions of patients in need around the world.”

The Company also announced the formation of the Ophthalmology Advisory Board (OAB), comprised of world-renowned retina specialists and thought leaders. The OAB will be chaired by Arshad M. Khanani, M.D., M.A., FASRS, Director of Clinical Research at Sierra Eye Associates and Clinical Professor at University of Nevada, Reno, and will support development strategy and registration across large market ophthalmology indications including wet AMD, DME, DR and GA.

“The wealth of clinical and global drug development experience that has been brought together under the OAB, in addition to our new senior leadership hires, provides 4DMT with unparalleled expertise in large market ophthalmology development,” added Dr. Kim. “As we prepare for our first Phase 3 clinical trial, the OAB will provide substantial support to maximize the value of our deep pipeline of retinal genetic medicines programs across multiple retinal disease indications. I look forward to working with our OAB members and new senior leaders to bring these important medicines to patients globally.”

Senior Management Hires

Dhaval Desai, PharmD, Chief Development OfficerDr. Desai has spent the past 20+ years working in all aspects of drug development with a focus on clinical development and medical affairs. Prior to joining 4DMT, Dr. Desai was SVP and Chief Development Officer at Iveric Bio (acquired by Astellas) where he led the clinical development, medical affairs and biostatistics departments responsible for the approval and launch of IZERVAY™, one of the first complement inhibitors approved for the treatment of GA. Before Iveric, Dr. Desai served as VP and Medical Unit Head of Ophthalmology at Novartis Pharmaceuticals, overseeing both the posterior and anterior segment therapeutic portfolios. In addition to these roles, Dr. Desai has also held leadership positions at other ophthalmology-focused biotech companies including Aerpio Therapeutics and ThromboGenics. Dr. Desai received his PharmD from and completed a post-doctoral industry fellowship at Rutgers University.

Chris Simms, Chief Commercial OfficerMr. Simms is an accomplished healthcare leader with more than 20 years of diverse commercial leadership experience at Iveric Bio (acquired by Astellas), Johnson & Johnson, Genentech and Novartis, including focused experience in retina, ophthalmology and optometry. Most recently he was SVP and Chief Commercial Officer at Iveric where he built and led the commercial team from pre-commercialization through the successful U.S. launch of IZERVAY™. Prior to joining Iveric, Mr. Simms served as Vice President and Head of the Novartis U.S. Ophthalmics business unit which included the brands BEOVU® and Xiidra®. He joined Novartis in 2017 to build the commercial launch strategy for BEOVU® after leading commercial efforts on LUCENTIS® at Genentech. Prior to Genentech, he spent 16 years at Johnson & Johnson working with leading brands across their vision care, diabetes and consumer goods businesses in Canada, Japan and the U.S. Mr. Simms has a Bachelor of Commerce from Memorial University of Newfoundland and an MBA from York University, Toronto, Canada.

Carlos Quezada-Ruiz, M.D., FASRS, SVP, Therapeutic Area Head, OphthalmologyDr. Quezada-Ruiz joins 4DMT from Genentech (a Roche company) where he served in the Ophthalmology management team as Group Medical Director, Clinical Science, Product Development. During his tenure at Genentech, he led the design, execution and readouts for U.S. and global registrational trials across multiple retinal diseases, including the wet AMD global clinical development program for VABYSMO, leading to U.S. and global approvals and the global clinical science team for SUSVIMO, supporting its initial FDA approval and launch in wet AMD, successfully leading his team through the U.S. voluntary recall and recent commercial relaunch. In addition, he led the DR and DME Phase 3 registrational programs. Dr. Quezada-Ruiz also oversaw the Medical Affairs team efforts for the U.S. launch of Lucentis Prefilled Syringe (PFS) and the Myopic Choroidal Neovascularization indication for LUCENTIS. Additionally, he played a pivotal role in the advancement of personalized healthcare in retina within Genentech by helping design and develop predictive models using machine learning and large language models to support drug development and clinical practice. Dr. Quezada-Ruiz is a practicing retina specialist and fellow of the American Society of Retina Specialists, with over 13 years of vitreoretinal clinical practice and research. Dr. Quezada-Ruiz received his M.D. from Universidad Autónoma de Coahuila, and completed fellowships in Vitreoretinal Surgery, Ocular Pathology-Research, and Retinal Disease and Vitreoretinal Surgery Research from Universidad Nacional Autónoma de México, McGill University, and the California Retina Research Foundation. He obtained a CIBE from Columbia Business School, Executive Education.

Ophthalmology Advisory Board

Arshad M. Khanani, M.D., M.A., FASRS (Chair): Managing Partner, Director of Clinical Research and Director of Fellowship at Sierra Eye Associates, and Clinical Professor at the University of Nevada, Reno School of Medicine. He has served as the principal investigator for more than 120 clinical trials and has over 150 scientific publications. Dr. Khanani is an elected member of the Macula Society and Retina Society. He has received numerous awards of distinction including the prestigious American Society of Retina Specialists (ASRS) Presidents’ Young Investigator Award and the ASRS Presidential Award.

David S. Boyer, M.D.: Senior Partner at the Retina-Vitreous Associates Medical Group, and an Adjunct Clinical Professor of Ophthalmology at the University of Southern California/Keck School of Medicine in Los Angeles, California. He is a board-certified ophthalmologist specializing in the treatment of diseases of the retina and vitreous, and a leading clinical researcher for new treatments in macular degeneration and DME.

Frank G. Holz, M.D., FEBO, FARVO: Professor and Chairman of the Department of Ophthalmology at the University of Bonn, Germany. He founded the GRADE Reading Center and the Medical Imaging Center Bonn, with a focus on innovative retinal imaging technologies and image analysis strategies. His research focuses on the pathogenesis, structural and functional biomarkers, and new therapies for macular and retinal diseases. He has published more than 600 articles in peer-reviewed journals and has received numerous awards including the Pro Retina Macular Degeneration Research Award, the Leonhard-Klein Award for Ocular Surgery, the Alcon Research Institute (ARI) Award, the Senior Achievement Award of the AAO and the Jules Gonin Award.

Anat Loewenstein, M.D., MHA: Professor and Director, Division of Ophthalmology at the Tel Aviv Medical Center, VP Ambulatory Services at the Tel Aviv Medical Center, Sidney Fox Chair of Ophthalmology at the Sackler Faculty of Medicine at Tel Aviv University, Israel, and President of EURETINA. She has published more than 500 papers in peer reviewed journals and has contributed multiple chapters to ophthalmology textbooks. Her focus is the investigation of drug administration and toxicity to the retina, early detection of macular degeneration and home monitoring of retinal disease.

Dante Pieramici, M.D.: Managing Partner at California Retina Consultants, President of the California Retina Research Foundation, a member of the Medical Leadership Board of the Retina Consultants of America. Currently, he is the Medical Director of Clinical Research at California Retina Consultants. Dr. Pieramici has served as the principal, sub, reading center investigator or advisor for over 100 clinical trials. His research has focused primarily on new surgical and pharmacologic treatments for age-related macular degeneration and diabetic-related eye diseases.

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 helps 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 six clinical-stage and one preclinical product candidate, 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™, 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 U.S. Food and Drug Administration (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 and market potential of 4DMT’s product candidates, as well as the plans, announcements, and related timing for the clinical development of, regulatory interactions regarding, and potential commercialization of 4D-150 and 4D-175 and 4D-150's potential to be a pipeline-in-a-product. 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 SmithInizio Evoke CommsKatherine.Smith@inizioevoke.com

Investors:Julian PeiHead of Investor Relations and Corporate FinanceInvestor.Relations@4DMT.com