On March 18, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company developing novel cell and gene therapies for serious diseases, reported fourth quarter and full year 2018 financial results, and provided business highlights (Press release, Abeona Therapeutics, MAR 18, 2019, View Source [SID1234534483]). The Company will host a conference call on Tuesday, March 19 at 10:00 a.m. ET to discuss fourth quarter and full year results, and to provide business highlights. Interested parties are invited to participate in the call by dialing 844-369-8770 (toll-free domestic) or 862-298-0840 (International) or via webcast at View Source

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"The diligent work conducted over the past nine months at our GMP manufacturing facility puts us on track to initiate the pivotal VITAL study evaluating EB-101, our gene-corrected cell therapy for the treatment of recessive dystrophic epidermolysis bullosa, in mid-2019. We will produce EB-101 at our Cleveland facility, which is an important milestone for Abeona. We are also advancing our manufacturing capabilities to support our AAV gene therapy programs and expect to be at scale for GMP production in the second half of this year," said João Siffert, M.D., Chief Executive Officer. "On the lysosomal storage disease programs, we have stepped up efforts to accelerate patient enrollment in the MPS III programs and recently implemented the protocols to enroll younger, higher functioning patients."

"We believe that these important steps have positioned Abeona for success in 2019 as we focus on advancing our clinical programs and developing our pipeline utilizing novel AAV capsids," added Dr. Siffert.

Fourth Quarter and Full Year Summary Financial Results:

Cash, cash equivalents and marketable securities as of December 31, 2018 were $85.0 million, compared to $112.2 million as of September 30, 2018. The decrease in cash of $27.2 million was driven primarily by the net cash used for operating activities of $17.0 million and cash used for the acquisition of the REGENXBIO license of $10 million.

Revenues were $0.5 million for the fourth quarter of 2018 compared with $0.2 million for the fourth quarter of 2017. The increased quarterly revenues resulted from the recognition of Foundation grants that were announced during the fourth quarter of 2017.

Net loss was $0.36 per share for the fourth quarter of 2018, compared to $0.19 per share in the comparable period in 2017. For the twelve months ended December 31, 2018, net loss was $1.19 per share compared to $0.66 per share in the same period in 2017.

Fourth Quarter and Recent Highlights:

·December 6, 2018: Provided lead program updates and unveiled data from AIM AAV vector platform in cystic fibrosis and retinal diseases at R&D Day

·January 8, 2019: Appointed Christine Silverstein as Chief Financial Officer and Ed Carr as Chief Accounting Officer

·February 5-6, 2019: Presented new supportive data for novel gene therapies, including new proof-of-concept data for the AIM vector platform at WORLDSymposium

·February 11, 2019: Appointed João Siffert, M.D. as Chief Executive Officer

"As a fully-integrated organization, Abeona is on the forefront of cell and gene therapy thanks to in-house manufacturing facilities, the AIM AAV vector platform, and two programs in the clinic that have exclusive license to the AAV9 vector," said Steven H. Rouhandeh, Chairman of the Board and Executive Chairman. "Under João’s leadership, the Company is focused on maximizing these end-to-end capabilities as it prepares for important near-term milestones and beyond."