Aerpio Therapeutics, Inc.

近日，精准肿瘤公司Aadi Bioscience宣布将裁撤其研发人员的80%，Aadi本身也会聘请一家外部咨询公司寻求股东价值最大化。根据该公司公告，管线调整和R&D员工的人力资源减少将至少将其现金跑道延长至2026年下半年。 导致该公司做出这一决定的是该公司核心管线白蛋白结合型西罗莫司的II期临床数据。独立数据监测委员会的分析表明，该研究不太可能到达支持加速批准所需的疗效阈值。这使得该公司将暂停PRECISION1注册意向试验。 其实解雇的预兆在此前8月16日发布的SEC文件中就可以看到，当时该公司宣称将将解雇22名员工，占其员工总数的32%，而该公司共有48名研发人员，考虑到80%的裁撤，届时该公司可能不剩下多少研发人员了，被收购可能是这家公司未来的结局。 有趣的是，目前岌岌可危的Aadi本身也是收购其他公司的产物。在2021年时，已经走向破产道路的眼科治疗公司Aerpio Pharmaceuticals通过拍卖资产与Aadi Bioscience合并，合并后的Aadi Bioscience全力开始推动白蛋白结合型西罗莫司，尽管如此，这一举措仍未能拯救白蛋白结合型西罗莫司的颓势。 白蛋白结合型西罗莫司的失利 白蛋白结合型西罗莫司可以说是Aadi Bioscience公司的核心。机制机理来自于mTOR信号通路抑制。而白蛋白结合型药物能够利用白蛋白的自然属性，通过血液循环系统流经肿瘤组织血管时，通过EPR效应（增强渗透滞留效应）富集于肿瘤组织间液，实现药物的靶向递送，因此就能实现mTOR抑制剂对肿瘤的靶向。 该公司围绕白蛋白结合型西罗莫司打造了数条管线，也确实成功在一项罕见癌种中成功推动上市了一项产品（商品名：Fyarro） 罕见的小癌种是血管周围上皮样细胞瘤（PEComa），这一小癌种是软组织肉瘤中的罕见亚型，早先的研究发现，PEComa常常会伴有TSC1和/或TSC2基因突变，而TSC1和/或TSC2基因突变会导致下游mTOR信号通路激活。 那么能否证明在PEComa小癌种中的成功能够在同基因突变条件下的实体瘤中复刻，就成为了拓宽市场的重点。 毕竟PEComa这一小癌种患者人数较少，药品定价也不高，收入相当微薄，今年Q2一季度才卖出了620万美元。 但这次失利的临床恰巧就是TSC1或者TSC2基因突变的实体瘤患者，这也意味着拓宽适应症的尝试基本以失利告终，情势不容乐观。 现在还剩下子宫内膜癌(EEC)和神经内分泌肿瘤(NETs)的数据等待读出。 本周好文推荐 如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

Dhaval Desai, PharmD, named as Chief Development Officer; will oversee late-stage Product Development, Medical Affairs, Scientific Communications, Regulatory and Quality operations; most recently SVP & Chief Development Officer at Iveric Bio where he led development and approval of IZERVAYChristopher Simms named as Chief Commercial Officer, effective September 25, 2024; will oversee Pre-commercial and Commercial organizations, pre-launch preparations and development; most recently SVP & Chief Commercial Officer at Iveric Bio where he led commercial strategy and execution for the launch of IZERVAYCarlos Quezada-Ruiz, M.D., FASRS, named as SVP, Therapeutic Area Head, Ophthalmology; will lead the Ophthalmology franchise and oversee early- and late-stage clinical development; most recently Group Medical Director, Ophthalmology at Genentech where he led clinical development and approval of VABYSMO and SUSVIMOOphthalmology Advisory Board comprised of world-renowned retina specialists and thought leaders to support development strategy and registration for large market ophthalmology programs: Dr. Arshad Khanani (Chair), Dr. David Boyer, Dr. Frank Holz, Dr. Anat Loewenstein, Dr. Dante Pieramici EMERYVILLE, Calif., Aug. 05, 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 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

Industry Leader and Retina Expert, Pravin U. Dugel, MD, Becomes Executive Chair Jeffrey S. Heier, MD to become Chief Scientific Officer, Peter K. Kaiser, MD to be Medical Director, and Sanjay Nayak, MBBS, PhD to become Chief Strategy Officer Addition of Strategic and Clinical Experts Puts Ocular on Track to be a Leader in Retina Care Expanded Team Anticipated to Accelerate Momentum in AXPAXLI™ Phase 3 Wet AMD Programs BEDFORD, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced Board of Directors and leadership updates with the addition of Pravin U. Dugel, MD as Executive Chairman and the additions of Jeffrey S. Heier, MD, Peter K. Kaiser, MD, and Sanjay Nayak, MBBS, PhD to the Ocular management team as Chief Scientific Officer, Medical Director, and Chief Strategy Officer, respectively. The addition of these four acknowledged strategic and clinical experts puts the Company on track to be a leader in retina care for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other retinal conditions. The Company also announced that Charles Warden has transitioned from Chairman of the Board to Lead Independent Director. To enable full transitions to their new operating roles, Dr. Heier has resigned from his positions with the Company as a Board Director and Advisor – Retina, and Dr. Kaiser has resigned from his position as Chief Medical Advisor – Retina of the Company. In addition, Peter Jarrett, PhD, has begun the new role of Chief Technical Officer. Rabia Gurses Ozden, MD, will continue in her role as Chief Medical Officer. “We are bringing together the ‘Retina Dream Team’ to position Ocular at the forefront of retina care, further energizing the momentum behind the AXPAXLI™ Phase 3 wet AMD program. We believe our expanded leadership team will enable us to potentially accelerate the pace of our clinical program for AXPAXLI™,” said Antony Mattessich, CEO of Ocular Therapeutix. “With our renewed focus on retinal disease, we are thrilled to welcome Dr. Dugel as Executive Chairman. He is a visionary executive who brings a history of successful company building and organizational development that we believe will help us make Ocular a leader in retina care. On behalf of everyone on the management team, I look forward to working closely with Dr. Dugel. We believe that his track record of advancing novel products for retinal disease, along with his extensive network and long-standing relationships across the field of retinal disease, have the potential to substantially accelerate our mission to develop and commercialize products to enhance people’s vision and quality of life.” “In addition, we believe that Drs. Heier and Kaiser’s decision to join the management team in operating roles is an incredible asset for the Company,” commented Mr. Mattessich. “Each of these globally recognized retina specialists bring a deep understanding of the AXPAXLI™ program, Ocular’s pipeline and the ELUTYX™ proprietary formulation technology. We believe their experience as study chairman or lead investigators in numerous pivotal trials of approved products for wet AMD and other ophthalmic indications will help the Company optimize the enrollment of the AXPAXLI™ Phase 3 pivotal trials and enhance the probability of success. Dr. Nayak further strengthens our team, bringing a unique market perspective in retinal disease and ophthalmology from his deep expertise as a strategy consultant and healthcare investor.” Dr. Dugel said, “I am honored to join Ocular’s accomplished and talented Board as we advance the development of AXPAXLI™ and re-define the Company as the leader in retina care. I have dedicated my life to the development of novel therapies for retina diseases, and I believe that AXPAXLI™ has the opportunity to substantially transform the care of patients with wet AMD and hopefully other retinal diseases. In my role as Executive Chairman, I look forward to working with Antony and the management team to successfully complete the AXPAXLI™ Phase 3 program and define and innovate the next steps in the Company’s strategic development.” Dr. Heier commented, “Through my prior roles as Board Director and Advisor – Retina, I have observed the steady development of a strong clinical database for AXPAXLI™, starting with earliest studies. With the Phase 3 program underway, I am thrilled to be part of the Team.” Dr. Kaiser noted further, “I joined Ocular as a Chief Medical Advisor – Retina because I believed AXPAXLI™ and the ELUTYX™ platform could be a ‘game-changer’ in the care of retinal disease. From my experience as a retina specialist, I know that patients are hoping for improved therapies. I am thrilled to be part of the Ocular Team as we advance the Phase 3 AXPAXLI™ program.” Dr. Nayak added, “I am excited about this amazing opportunity to join Ocular, along with this group of esteemed retinal experts and industry champions. Together with the entire Ocular team, we are hoping to address the single biggest unmet need for our patients: a safe, effective, and truly durable therapy for retinal and ophthalmic indications. I am grateful to Antony and Pravin for letting me play a significant role in what we expect will be a transformative time for the Company.” Mr. Mattessich concluded by sharing, “On behalf of the Ocular team, I am so grateful to Charles Warden for his prior work as Board Chairman and his guidance regarding the Company’s organizational development and strategic focus. As Ocular moves forward, I am very pleased that Charles will continue his work with the Company as Lead Independent Director.” About Dr. Dugel, Executive Chairman of the Board, Ocular Therapeutix Pravin U. Dugel, MD has held previous leadership roles including President of IVERIC Bio, Inc., Managing Partner, Retinal Consultants of Arizona and the Retinal Research Institute; Clinical Professor, USC Eye Institute, Keck School of Medicine, University of Southern California; and Founding Member, Spectra Eye Institute in Sun City, Arizona. Dr. Dugel has authored more than 200 papers and 35 book chapters, and has been invited to give prestigious named lectures at marquis medical meetings and to serve as a visiting professor at universities worldwide, including in Japan, India, Nepal, China, Malaysia, Egypt, the United Kingdom, France, Germany, Austria, Italy, Poland, Denmark, Norway, the Czech Republic, Canada, and Australia. He is on the editorial board of several major medical journals. Dr. Dugel is internationally recognized as a major clinical researcher and has been a principal investigator in over 100 multicenter clinical trials. His research and educational contributions earned him the prestigious Honor Award, Senior Honor Award and Lifetime Achievement Award from the American Academy of Ophthalmology (AAO). He has been elected and previously served as the Retina Subspecialty Day Board Chairman for the American Academy of Ophthalmology Annual Meeting, as a member of the Board of Directors of the largest retina society in the United States, the American Society of Retina Specialists (ASRS), and the largest retina society in Europe, EURETINA. Additionally, he has been elected to the Retina Society, Macula Society, and the Retina Hall of Fame. Dr. Dugel has served as the Chair of the Scientific Advisory Board for major companies, including Novartis, Roche, Genentech, Allergan (Abbvie), Oxurion (Thrombogenics), Oculis, and Alcon. He has consulted for over 50 companies and has previously served on the IVERIC Bio and Aerpio Therapeutics Boards of Directors. Dr. Dugel has been a member of the Board of Directors and Chair of Orbis International’s Medical Advisory Board and Medical Strategic Committee. Orbis International is a non-profit organization focused on ophthalmology training and education in the developing world. With Orbis, Dr. Dugel travels to developing countries to teach surgical techniques to local ophthalmologists and provide free surgery. In Arizona, Dr. Dugel founded an aviation company allowing him to travel to the Navajo, Hopi and Pima Indian Reservations to treat Native American patients suffering from preventable blindness. Dr. Dugel was born in Kathmandu, Nepal, grew up in Vienna, Austria and attended Harrow School in London, England. He graduated summa cum laude from Columbia University in New York City and was elected to the Phi Beta Kappa Society. He was also captain of the Columbia Squash team. He then attended the UCLA School of Medicine, completing his residency in ophthalmology at the USC Eye Institute, Keck School of Medicine. Thereafter, he completed his medical retina fellowship at the Bascom Palmer Eye Institute and surgical retina fellowship at the USC Eye Institute, where he received both the Heed Foundation Fellowship award and Ronald G. Michels Foundation Fellowship award. About Dr. Heier, Chief Scientific Officer, Ocular Therapeutix Jeffrey S. Heier, MD, is and will continue to serve as the Director of the Vitreoretinal Service and Director of Retina Research at Ophthalmic Consultants of Boston (OCB), one of the largest multi-specialty ophthalmology practices in the United States. Dr. Heier served as Co-President & Medical Director of OCB from 2016-2020. Dr. Heier is the Immediate Past President of the Retina Society and served as a member of the Executive Committee of the American Society of Retina Specialists from 2016 to February 2024. He is the Past President of the New England Ophthalmological Society and a member of the Macula Society. Dr. Heier is one of the leading retinal clinical researchers in the country for new treatments in exudative and non-exudative macular degeneration, diabetic macular edema, venous occlusive disease, vitreoretinal surgical techniques and instrumentation, and diagnostic imaging of the retina. He has served as one of the national or international lead investigators on numerous landmark clinical trial programs, including the Phase 3 trials of pegcetacoplan for advanced dry AMD, aflibercept and ranibizumab for neovascular AMD, and the dexamethasone implant for retinal venous occlusive disease. Dr. Heier serves as the chair of multiple scientific advisory boards and steering committees focusing on study design, outcomes analysis, and implementation of new agents into clinical practice. Dr. Heier has served as the Principal Investigator in more than 200 clinical trials. He lectures nationally and internationally, and has authored over 140 peer-reviewed works. Dr. Heier has received the Life Achievement Honor Award, The Secretariat Award, The Senior Achievement Award, and the Honor Award from the American Academy of Ophthalmology, and The Presidential Honor Award, The Senior Honor Award, and the Honor Award from the American Society of Retina Specialists. Dr. Heier was selected as a charter inductee of the Retina Hall of Fame in 2017. Dr. Heier received his medical degree from Boston University, completed an internship and residency at Fitzsimons Army Medical Center, and a vitreoretinal fellowship at Ophthalmic Consultants of Boston/Tufts School of Medicine. He served as a physician in a Combat Support Hospital in the Persian Gulf War, where he was awarded a Bronze Star. About Dr. Kaiser, Medical Director, Ocular Therapeutix Peter K. Kaiser, MD, was appointed as a Staff member of the vitreoretinal faculty of the Cole Eye Institute at Cleveland Clinic in 1997, where he now holds the Chaney Family Endowed Chair in Ophthalmology Research and will continue to serve as Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine. As a National Eye Institute and National Institute of Health RO1-funded principal investigator, Dr. Kaiser leads a team involved in the evaluation of vascular biology in age-related macular degeneration and diabetic retinopathy. In addition, Dr Kaiser is actively involved in clinical research having served as Study Chairman for numerous major, multi-center, international clinical trials, and principal investigator in over 60 trials evaluating new treatments for AMD, diabetic retinopathy, and other retinal disorders. Complementing his research endeavors, Dr. Kaiser serves as the Chair of numerous scientific advisory boards and study steering committees and addresses his research interests as an invited speaker at national and international conferences. Dr. Kaiser is also the Founding Director of the Cole Eye Reading Center which is involved as a reading center in numerous retinal clinical studies. Dr. Kaiser is a major contributor to medical literature, having authored several ophthalmology texts and more than 400 peer-reviewed original reports. He is Editor-in-Chief of Retinal Physician, Associate Editor of International Ophthalmology Clinics, and serves on the editorial boards of American Journal of Ophthalmology, Retina, Retina Today, and Ocular Surgery News. He has been elected and previously served as the Retina Subspecialty Day Board Chairman for the American Academy of Ophthalmology Annual Meeting, as a member of the Board of Directors of the American Society of Retina Specialists (ASRS), and is a member of the Retina Society, Macula Society, EURETINA, and American Ophthalmological Society. Dr. Kaiser has been recognized by the American Society of Retina Specialists with Honor and Senior Honor Awards, by the American Academy of Ophthalmology with Achievement, Senior Achievement, and Lifetime Achievement Awards. He has been listed as one of the “Best Doctors in America” every year since 2002 and named one of the “150 Top Innovators in Retina” by Ocular Surgery News, selected as a charter inductee of the Retina Hall of Fame in 2017, and appeared on the biannual Ophthalmologist’s “Power List” in 2016, 2018, and 2020 as one of the top 100 most influential people in the world of ophthalmology. He is the team ophthalmologist for the Cleveland Cavaliers of the National Basketball Association. Dr. Kaiser graduated magna cum laude with Highest Honors from Harvard College and received his medical degree magna cum laude from Harvard Medical School. He completed an internship in internal medicine at Massachusetts General Hospital, an ophthalmology residency at the Massachusetts Eye and Ear Infirmary and a surgical retinal fellowship at Bascom Palmer Eye Institute where he received the Heed Foundation Fellowship Award. About Dr. Nayak, Chief Strategy Officer, Ocular Therapeutix Sanjay Nayak, MBBS, PhD, was the founder and fund manager of a biotech-focused private investment fund, Sentiv Capital. The fund invested in public and private biotechnology companies and has been a sought-after co-investor, based on the quality and depth of his due diligence and contributions to investment strategy. Dr. Nayak’s investment approach integrated more than 20 years of expertise in retina and ophthalmology with strong connections spanning industry, the investment community and top key opinion leaders, as well as a unique strategic acuity related to healthcare markets. Prior to founding Sentiv Capital, Dr. Nayak was the founder and Managing Partner at AnalyzeRx LLC, a well-respected healthcare consulting practice focused on delivering customized, high-end, qualitative market analytics and competitive strategy to large-cap pharmaceutical and biotechnology companies. The firm developed a differentiated perspective on retinal therapeutics and provided competitive analysis, strategic guidance and supported the business development needs of its clients for more than fifteen years. Prior to his work at AnalyzeRx LLC, Dr. Nayak was a Director at Strategic Analysis, Healthcare, which was acquired by IMS Health. His consulting work was focused on pharmaceutical competitive analysis encompassing commercial launch preparations and regulatory, pipeline and clinical trial evaluations. Dr. Nayak received his medical degree (MBBS) from Grant Medical College, University of Bombay, India and earned a PhD in pharmacology from Drexel University, Philadelphia, Pennsylvania. He is the author or co-author on several publications related to presynaptic receptors in the brain. About Ocular Therapeutix, Inc.Ocular Therapeutix, Inc. is a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for diseases and conditions of the eye. Ocular’s program for retinal disease is led by AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI), based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI™ is currently in the first of two pivotal Phase 3 trials for wet AMD and a Phase 1 clinical trial for the treatment of diabetic retinopathy. The clinical portfolio also includes PAXTRAVA™ (travoprost intracameral implant, also known as OTX-TIC), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension. Ocular’s expertise in the formulation, development and commercialization of innovative therapies and ELUTYX™ platform supported the FDA approval and launch of its first commercial drug product, DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis, as well as the ongoing development of two other clinical-stage assets, OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease, and several preclinical programs. Follow us at https://www.ocutx.com/, Ocular Therapeutix, Inc. | LinkedIn and https://twitter.com/OCUTX Forward Looking StatementsAny statements in this press release about future expectations, plans, and prospects for the Company, including the development and regulatory status of the Company’s product candidates, including the timing, design, and enrollment of the Company’s pivotal trials of AXPAXLI™ (also called OTX-TKI) for the treatment of wet AMD; the Company’s plans to advance the development of AXPAXLI™ and its other product candidates; and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA or any product or product candidate that receives regulatory approval; the ability to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval;; the initiation, design, timing, conduct and outcomes of clinical trials, including the SOL-1 trial, the planned SOL-2 and the Company’s other ongoing clinical trials; the risk that the FDA will not agree with the Company’s interpretation of the written agreement under the SPA for the SOL-1 trial; the risk that even though the FDA has agreed with the overall design of the SOL-1 trial, the FDA may not agree that the data generated by the SOL-1 trial supports potential marketing approval; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials; availability of data from clinical trials and expectations for regulatory submissions and approvals; the risks that the management hires referenced in this release are not successful in achieving the anticipated results; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; C and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. InvestorsOcular TherapeutixDonald NotmanChief Financial Officerdnotman@ocutx.com OrJoyce AllaireLifeSci Advisorsjallaire@lifesciadvisors.com