Full Press Release Details
Announces New Chairman, Executive Leadership Promotions and
Key Talent Additions for Final Push Towards Two Biologics License
H. Rouhandeh to retire as Chairman of the Board; Michael Amoroso appointed Chairman of the Board
Seshadri, Ph.D., M.B.A. to become Chief Executive Officer
M. O'Malley, J.D., Ph.D. promoted to General Counsel, Brian Kevany, Ph.D. promoted to
Chief Technical Officer, Scott Nogi, M.B.A.,
Head of Business Operations to expand role and
lead operations at Abeona's Cleveland facility
veterans in AAV-based gene therapy, Carl Denny and Kate Imhoff, added to team in
preparation for two upcoming Biologics License Application
YORK and CLEVELAND, Sept 21, 2021 - 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.
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.
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.
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.
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."
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.
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."
Team Promotions and Key Appointments
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.
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.
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.
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.
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.
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.
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.
Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeona's
clinical programs include EB-101, its investigational autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis
bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel investigational AAV-based gene therapies for Sanfilippo syndrome
types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Company's development portfolio also features
AAV-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona's novel, next-generation AAV capsids are
being evaluated to improve tropism profiles for a variety of devastating diseases. Abeona's fully integrated gene and cell therapy
cGMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL study and is capable of clinical and planned commercial
production of AAV-based gene therapies. For more information, visit www.abeonatherapeutics.com.
press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted
to identify forward-looking statements by such terminology as "may," "will," "believe," "estimate,"
"expect," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances),
which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited
to the potential impacts of the COVID-19 pandemic on our business, operations, and financial condition, continued interest in our rare
disease portfolio, our ability to enroll patients in clinical trials, the outcome of any future meetings with the U.S. Food and Drug
Administration or other regulatory agencies, the impact of competition, the ability to secure licenses for any technology that may be
necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of changes in the
financial markets and global economic conditions, risks associated with data analysis and reporting, and other risks disclosed in the
Company's most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q and other periodic reports filed
with the Securities and Exchange Commission. The Company undertakes no obligation to revise the forward-looking statements or to update
them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future
developments or otherwise, except as required by the federal securities laws.
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