ABEO Abeona Therapeutics Inc.

Abeona Therapeutics Announces Appointment of Michael Amoroso as Chief Commercial Officer

Abeona Therapeutics Announces Appointment of Michael Amoroso as Chief Commercial Officer

To lead Abeona’s commercial organization, EB-101 commercialization planning and pre-commercial strategy for AAV-based gene therapy programs

NEW YORK and CLEVELAND, July 09, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Michael Amoroso as Senior Vice President and Chief Commercial Officer (CCO), effective immediately. Mr. Amoroso brings to Abeona over 20 years of product commercialization experience in the biotechnology and pharmaceutical industries, most recently as Senior Vice President and Head of Worldwide Commercial, Cell Therapy at Kite, a Gilead Company.

Mr. Amoroso will have overall responsibility for building the Company’s commercial organization, developing the commercialization strategy for EB-101, its autologous, gene-corrected cell therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) and its lead product candidate, as well as leading pre-commercial planning for its investigational adeno-associated virus vector (AAV)-based gene therapies.

“Michael is a highly accomplished commercial leader with a focus on cell and gene therapies and a proven track record of launching innovative drugs for rare diseases,” said João Siffert, M.D., Chief Executive Officer of Abeona. “As we advance our pivotal Phase 3 VIITAL™ study of EB-101 in RDEB, Michael’s proven track record in commercialization, supply chain management for personalized, autologous cell therapies, experience in developing novel launch plans, working closely with governments around the world to ensure patients have access, and ability for building commercial and organizational capabilities will lay the groundwork for our potential go-to-market strategy for EB-101. Furthermore, his history of integrating commercial perspective into pipeline programs will be instrumental in positioning our investigational AAV gene therapies to shape the treatment paradigm for patients with MPS IIIA, MPS IIIB, and other rare genetic diseases.”

Prior to joining Abeona, Mr. Amoroso held various senior level commercial positions at leading biopharmaceutical companies, including Kite, Eisai Inc., Celgene Corporation (now a subsidiary of Bristol-Myers Squibb Company), and Sanofi. At Kite, he was responsible for the company’s worldwide commercial organization leading the commercialization efforts for the autologous CAR T-cell therapy, YESCARTA®, and the future cell therapy pipeline. Before Kite, Mr. Amoroso was Senior Vice President, Americas for Eisai’s Commercial Oncology Business Group, where he was accountable for teams charged with creating and driving commercial strategy and implementation for the company’s approved products and earlier-stage assets. Previously, Mr. Amoroso worked at Celgene for six years in several commercial roles before serving as the organization’s Commercial Lead for CAR T-cell therapy programs. In this capacity, he helped Celgene develop an organizational model to commercialize cell therapies including specialized manufacturing and customer services for patients with lymphoma and myeloma. Before joining Celgene, Mr. Amoroso held various marketing and sales leadership positions over his 10-plus year tenure at Sanofi. Mr. Amoroso earned his M.B.A. in Management from the Stern School of Business, New York University, and his B.A. in Biological Sciences, summa cum laude, from Rider University.

About Abeona Therapeutics

Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeona’s clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel 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 portfolio of AAV-based gene therapies also features ABO-202 and ABO-201 for CLN1 disease and CLN3 disease, respectively. Abeona’s library of novel, next-generation AIM™ capsids have shown potential to improve tropism profiles for a variety of devastating diseases. Abeona’s fully functional, gene and cell therapy GMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITALTM study and is capable of clinical and commercial production of AAV-based gene therapies. For more information, visit .

Forward-Looking Statements

This 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.  These statements include statements about the Company’s clinical trials and its products and product candidates, future regulatory interactions with regulatory authorities, as well as the Company’s goals and objectives.  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 as may be detailed from time to time in the Company’s Annual Reports on Form 10-K and quarterly reports on Form 10-Q and other periodic reports filed by the Company 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 presentation, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

Investor Contact:

Greg Gin

VP, Investor Relations

Abeona Therapeutics

+1 (646) 813-4709

Media Contact:

Scott Santiamo

Director, Corporate Communications

Abeona Therapeutics

+1 (718) 344-5843

EN
09/07/2020

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