Business
Abeona Therapeutics Reports Second Quarter 2023 Financial Results
On track for Biologics License Application (BLA) submission in third quarter of 2023 Proceeds from $25 million registered direct offering in July allow
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"On track for Biologics License Application (BLA) submission in third quarter of 2023 Proceeds from $25 million registered direct offering in July allow initiation of pre-commercial launch activities for EB-101 Cash on hand plus proceeds from registered direct offering projected to fund operations into the fourth quarter of 2024 CLEVELAND, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the second quarter of 2023 and provided an update on progress toward achieving key corporate objectives. “Abeona is at a pivotal moment in our history as we are busy finalizing and planning to soon submit the BLA for EB-101 for the treatment of recessive dystrophic epidermolysis bullosa,” said Vish Seshadri, Chief Executive Officer of Abeona. “The recent capital raise allows us to initiate preparations for the commercial launch of EB-101 in the U.S., while also extending our cash runway well beyond the anticipated regulatory approval time for EB-101.” Second Quarter and Recent Progress Strengthened balance sheet, preparing for commercialization of EB-101 in the U.S. In July, Abeona raised $25 million in a registered direct offering priced at-the-market with select existing investors to primarily fund initiation of the Company’s launch preparations in anticipation of the EB-101 BLA submission and potential approval. EB-101 for recessive dystrophic epidermolysis bullosa (RDEB) Completed the Process Performance Qualification manufacturing runs for both retroviral vector (RVV) and EB-101 drug product manufacturing to demonstrate Abeona’s validated process and readiness for commercial production. This data will be included in the chemistry, manufacturing, and controls (CMC) module for the EB-101 BLA submission.Generated the additional data requested by the U.S. Food and Drug Administration (FDA) that supports comparability between two RVV sources used in EB-101 clinical studies. This data will be included in the CMC module for the EB-101 BLA submission.Submitted the briefing package for the pre-BLA meeting with the FDA in August 2023 for its anticipated BLA submission of EB-101 in the treatment of RDEB. Abeona anticipates submitting the BLA in the third quarter of 2023.Additional efficacy and safety data from the pivotal Phase 3 VIITAL study of investigational EB-101 in RDEB were presented ...