ABEO stock rose in after-hours trading on December 31, 2019.

In a regulatory filing, Abeona Therapeutics’ Stefano Buono disclosed the purchase of 200,000 common shares of the company at a price of $2.50 per share, valued at $500,000 on December 24. This huge insider buy suggests something big is coming IMO.

On December 30, 2019, H.C. Wainwright analyst Raghuram Selvaraju lowered his price target for Abeona Therapeutics to $11 from $15 to account for the company’s recent sale of common stock and pre-funded warrants, telling investors that he believes the funds raised should extend the company’s operational runway into mid-2021. The analyst, who believes the company’s pivotal EB-101 program for recessive dystrophic epidermolysis bullosa is “likely to be rapid,” keeps a Buy rating on Abeona shares.

The company’s recent sale of common stock that Raghuram is referring to is that on December 24, 2019, Abeona Therapeutics announced the closing of its underwritten public offering, with a gross offering size of approximately $103.5 million, which includes the full exercise of the underwriters’ option to purchase 5,400,000 additional shares of common stock, at a public offering price of $2.50 per share. In addition, as part of the offering, Abeona sold to Great Point Partners (“GPP”), an existing investor, pre-funded warrants to purchase up to an aggregate of 9,017,055 shares of common stock at a purchase price of $2.4999 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded warrant.

The Company has granted to affiliates of GPP the right to nominate two Board members to Abeona’s Board of Directors, including a new Executive Chairman, due to GPP’s considerable investment in the transaction. As a result, Steven H. Rouhandeh will step down as Executive Chairman and will retain a seat on the Board, while Mark J. Alvino and Richard Van Duyne will exit the Board. These changes will be effective upon the Board’s qualification and election of GPP’s nominees. Such replacement members will be independent of GPP.

“Today’s event strengthens our financial position, providing cash runway into 2021 and resources that will allow us to fund continued clinical development of pipeline products, including the initiation and enrollment of the EB-101 pivotal Phase 3 VIITALTM study, and achieve critical near-term milestones,” said João Siffert, M.D., Chief Executive Officer of Abeona. “On behalf of the Board and all Abeona employees, I am grateful to our outgoing members for their service and dedication to the company, and particularly to Steven, who has served as Chairman of our Board of Directors for a number of years. Finally, I would like to thank our shareholders and new investors for their ongoing support and confidence in our pipeline and the Abeona team.”

“We are excited to lead this recapitalization of Abeona,” said David Kroin, Managing Director of Great Point Partners. “The Company is one of the world leaders in gene therapy technology, developing products using retrovirus, adeno-associated viruses and next generation capsids with potentially improved tropism profiles for a variety of devastating diseases. This funding greatly enhances Abeona’s financial position, and we believe it can now reach its full potential, as other gene therapy companies in which Great Point Partners has invested have been able to do. We intend to recruit the highest caliber people to guide the Company at the Board level in order to unlock the potential of a fully functioning manufacturing facility in Cleveland, Ohio, a late stage pivotal program in Recessive Dystrophic Epidermolysis Bullosa that has BreakThrough and RMAT Designations from the FDA, a pipeline of exciting neurology programs, and a wonderful team of professionals.”

Concurrently, the Company announced that its review of strategic options announced on September 3, 2019 has been completed. The Board of Directors concluded that it is in the best interest of the Company and its shareholders to develop its pipeline products independently, and with the additional funding and planned leadership nominations announced today. While the Board determined that this pathway was the best course of action to advance the Company’s mission and maximize stakeholder value, it was not due to a lack of interested partners, and Abeona continues to entertain strategic alternatives consistent with standard industry practices.

On December 20, 2019, Abeona Therapeutics Inc. (Nasdaq: ABEO) announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to the Company’s ABO-102 program studying its adeno-associated virus 9 (AAV9) gene therapy for Sanfilippo syndrome type A (MPS IIIA). The PRIME designation is based on nonclinical data and clinical data from the Transpher A Study, a global Phase 1/2 clinical trial evaluating a single-dose of ABO-102 for the treatment of children with MPS IIIA.

“EMA’s PRIME designation for the ABO-102 program recognizes the urgent need for a treatment option for children suffering from MPS IIIA, and underscores the potential of ABO-102 to modify the course of this devastating lysosomal storage disease,” said João Siffert, M.D., Chief Executive Officer.

The Transpher A Study is enrolling patients at sites in the U.S., Spain, and Australia.

The PRIME initiative provides access to enhanced support for the development of medicines targeting an unmet medical need. The designation affords sponsors with enhanced interaction and early dialogue regarding promising medicines, as well as the possibility of accelerated assessment of medicines applications. PRIME is intended to optimize development plans and speed up evaluation so these medicines can help patients to benefit as early as possible from therapies that may significantly improve their quality of life.

ABO-102 is a novel gene therapy in Phase 1/2 development for Sanfilippo syndrome type A (MPS IIIA), a rare lysosomal storage disease with no approved treatment that primarily affects the central nervous system (CNS). ABO-102 is dosed in a one-time intravenous infusion using an AAV9 vector to deliver a functional copy of the SGSH gene to cells of the CNS and peripheral organs. The therapy is designed to address the underlying SGSH enzyme deficiency responsible for abnormal accumulation of glycosaminoglycans in the brain and throughout the body that results in progressive cell damage and neurodevelopmental and physical decline. In the U.S., Abeona holds Regenerative Medicine Advanced Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations for the ABO-102 clinical program. In the EU, the Company holds PRIME and Orphan medicinal product designations.

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