Business
Abeona Therapeutics Reports Third Quarter 2019 Financial Results and Business Updates
Submitted additional EB-101 transport stability data to FDA in response to Clinical Hold Letter; CMC clearance for pivotal VIITALTM Phase 3 trial anticipated
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"Submitted additional EB-101 transport stability data to FDA in response to Clinical Hold Letter; CMC clearance for pivotal VIITALTM Phase 3 trial anticipated in Q4 2019Publication of positive long-term data for EB-101 demonstrated sustained wound healing, relief of pain and itch, and favorable safety profile three years post-treatmentOngoing strategic review of broad range of initiativesCompany to host investor conference call Wednesday, November 13 at 10:00 a.m. ET NEW YORK and CLEVELAND, Nov. 12, 2019 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced third quarter 2019 financial results and business updates, which will be discussed on a conference call scheduled for Wednesday, November 13 at 10:00 a.m. ET. Interested parties are invited to participate in the call by dialing 844-602-0380 (toll-free domestic) or 862-298-0970 (international) or via webcast at https://www.investornetwork.com/event/presentation/56788.\n “Abeona has made progress on our lead clinical program, EB-101, for the treatment of recessive dystrophic epidermolysis bullosa,” said João Siffert, M.D., Chief Executive Officer of Abeona. “We continue to anticipate receiving CMC clearance for this pivotal trial by year-end following the recent submission of additional transport stability data for EB-101, in response to the Clinical Hold Letter received in the quarter, as well as the submission of updated clinical and comparability protocols for the VIITALTM Phase 3 study.” Dr. Siffert continued, “We were also very pleased with the publication of positive long-term data from our Phase 1/2a clinical trial, reinforcing the potential of EB-101 to safely provide durable healing for the most challenging to treat, large and painful RDEB wounds. Three years post treatment, the majority of EB-101-treated wounds remained healed and without pain. We believe that EB-101 is uniquely positioned to address the needs of the majority of RDEB patients who suffer from these types of chronic wounds and we remain dedicated to delivering this therapy to the community.” Third Quarter Financial Results: Cash, cash equivalents and marketable securities as of September 30, 2019, were $47.9 million compared to $62.5 million as of June 30, 2019. The decrease in cash was driven primarily by the net cash used in ope...