Abeona Therapeutics (ABEO) Announces New Chairman, Executive Leadership Promotions and Key Talent

Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced Board appointments, executive leadership promotions, and additions of senior regulatory veterans to prepare for the potential of two Biologics License Application (BLA) submissions for EB-101 and ABO-102 currently in pivotal studies.

Steven Rouhandeh will retire from his position as Chairman of the Board and Board member of Abeona, effective October 14, 2021. Mr. Rouhandeh has served as a Director on Abeona’s Board since the Company’s public debut in 2015. The Board has appointed Michael Amoroso Chairman of the Board, effective October 15, 2021.

Dr. Vishwas (Vish) Seshadri, Ph.D., M.B.A., has been appointed President and Chief Executive Officer (CEO), and member of the Company’s Board of Directors, effective October 15, 2021. Until then, Dr. Seshadri will remain in his current role as Head of Research & Clinical Development and will lead the Company’s search for a new R&D leader with late-stage clinical and regulatory experience in preparation for two pivotal data readouts beginning in 2022.

Prior to joining Abeona, Dr. Seshadri served in roles of increasing responsibility at Celgene Corporation, now a subsidiary of Bristol-Myers Squibb Company (BMS), where he focused on development and commercialization of novel therapies in hematology and oncology. Most recently, he led the team responsible for the launch of Breyanzi® (lisocabtagene maraleucel; liso-cel), an autologous CD19-directed chimeric antigen receptor (CAR) T cell therapy for relapsed or refractory large B-cell lymphoma. Dr. Seshadri has more than 20 years of experience including academia and various senior and executive leadership roles in the life sciences industry overseeing product development, regulatory submissions, and commercialization for novel therapies including personalized, autologous cell and gene therapies.

Dr. Seshadri commented, “I am grateful to the Board and Michael for this opportunity to serve Abeona’s patients, shareholders, and employees. I have been fortunate to work directly with Michael for many years and look forward to continuing to learn from him in his new role as Chairman. Abeona has recently enhanced its BLA-ready talent with key additions across regulatory, clinical, quality and technical operations, and I look forward to leading our organization towards delivering top-line data for two pivotal clinical studies in RDEB and MPS IIIA. Our operational roadmap is clear, including alignment with the FDA for our two pivotal programs, and the Abeona team is motivated and laser-focused on delivering against the milestones that will enable us to bring both EB-101 and AAV-based gene therapy ABO-102 to patients as safely, effectively and quickly, as possible.”

As Chairman, Mr. Amoroso, along with the Board, will continue to play an important leadership role focusing on the longer-term strategic direction of the Company in its pursuit of bringing important therapies to patients and creating shareholder value. Mr. Amoroso will continue in his role as President and CEO through mid-October 2021, working seamlessly with Dr. Seshadri to ensure a thorough transition and business continuity across all Abeona stakeholders.

Mr. Amoroso said, “We are very appreciative of Steve’s dedicated service over the years and have benefitted from his leadership and contributions to Abeona. I am personally grateful that Steve delayed his retirement this past year to ensure a seamless transition for me as the President and CEO, while also preparing me to now take the reigns as Chairman of the Board. Additionally, I have known Vish personally and professionally over the past 10 years and have great confidence in his ability to lead Abeona in its critical final stages toward BLA submissions. Vish will continue to be surrounded by a highly talented and committed management team, as well as a purpose-driven and exceptional employee base. I look forward to working closely with Vish as he transitions into his new role.”

Executive Team Promotions and Key Appointments

Brendan O’Malley, J.D., Ph.D. has been promoted to Senior Vice President, General Counsel. Dr. O’Malley joined Abeona in May 2019 as Chief IP Counsel and was promoted to Head of Legal & IP in April 2020. In his role as General Counsel, Dr. O’Malley will leverage his significant legal and technical expertise in the biotechnology industry to oversee legal, corporate, IP, compliance, and other related matters for Abeona.

Brian Kevany, Ph.D. has been promoted to Vice President, Chief Technical Officer. Dr. Kevany joined the Company in January 2018 and has been instrumental in advancing Abeona’s preclinical ophthalmology programs. Dr. Kevany was promoted to Vice President, Manufacturing and Interim Head of Technical Operations in June 2021. As Chief Technical Officer, Dr. Kevany will oversee and direct all manufacturing, assay development, process development, and supply chain operations for Abeona.

Effective immediately, Scott Nogi, M.B.A., Vice President, Head of Business Operations will expand his role to include leading day-to-day operations as site head at Abeona’s Cleveland facility. Mr. Nogi, who joined the Company in March 2018, has been instrumental in the design and execution of the plans to expand Abeona’s manufacturing capabilities with the construction of a new 10,000+ square foot AAV manufacturing facility as the Company approaches commercialization of its AAV-based gene therapies.

Abeona has recently added gene and biopharmaceutical industry veterans with deep operational expertise across the areas of clinical development, regulatory, and quality, including the recent additions of proven regulatory leaders Carl Denny as Vice President, Regulatory Affairs and Kate Imhoff as Senior Director, Regulatory Affairs.

Mr. Denny joins the Company from Sarepta Therapeutics, Inc., and has over 20 years of experience in Chemistry Manufacturing and Controls (CMC) and regulatory affairs in the registration of gene therapies and mRNA products including AMONDYS 45 (casimersen) and AAV-based gene therapy Zolgensma® (onasemnogene abeparvovec-xioi). Carl has also served in multiple roles of increasing responsibility at AveXis, Inc., GE Healthcare, Takeda Pharmaceuticals, Catalent Pharma Services, Abbott Laboratories and Eli Lilly.

Ms. Imhoff joins the Company from Sarepta Therapeutics, Inc., and has over 15 years of experience in the pharmaceutical industry, including supporting AAV-based gene therapy submissions at AveXis, Inc. She has experience across various functions including regulatory affairs, quality systems, quality control, manufacturing/product support, and R&D.

These additions bolster the Company’s strong regulatory team that includes Advyzom, LLC, a leading consulting company led by Dr. Cindy Dinella, R.Ph. Pharm. D, formerly the Vice President of Drug Regulatory Affairs, Nutley Site Head for Global Development and Member of the CEO's North American Operating Committee at Hoffman La Roche Inc.

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