On August 8, 2023 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for the second quarter of 2023 and provided an update on progress toward achieving key corporate objectives (Press release, Abeona Therapeutics, AUG 8, 2023, View Source [SID1234633948]).
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"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 control (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.
● Abeona 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 at the International Societies for Investigative Dermatology (ISID) and Society for Pediatric Dermatology (SPD) meetings. The positive top-line data from the VIITAL study were reported in November 2022.
Preclinical programs
● Completed pre-Investigational New Drug Application (IND) meetings with the FDA regarding the preclinical development plans and regulatory requirements to support first-in-human trials for two preclinical gene therapy product candidates from its adeno-associated virus (AAV) ophthalmology program. The Company intends to initiate IND-enabling studies in the second half of 2023.
● Abeona presented new preclinical data at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper), including data on three internally developed preclinical gene therapy product candidates from its AAV ophthalmology program.
Second Quarter Financial Results
Cash, cash equivalents, restricted cash and short-term investments totaled $37.1 million as of June 30, 2023, prior to the $25 million registered direct offering in July 2023, as compared to $40.7 million as of March 31, 2023. Abeona estimates that its cash and cash equivalents, restricted cash and short-term investments as of June 30, 2023, in addition to the proceeds from the $25 million registered direct offering in July 2023, are sufficient resources to fund operations into the fourth quarter of 2024.
License and other revenues in the second quarter of 2023 were $3.5 million, compared to $1.0 million in the second quarter of 2022. Research and development expenses for the three months ended June 30, 2023 were $8.5 million, compared to $6.7 million for the same period of 2022. General and administrative expenses were $5.0 million for the three months ended June 30, 2023, compared to $3.5 million for the same period of 2022. Net loss attributable to common shareholders was $16.7 million for the second quarter of 2023, or $0.92 loss per common share as compared to a net loss attributable to common shareholders of $7.9 million, or $1.36 loss per common share, in the second quarter of 2022.
Conference Call Details
Abeona Therapeutics will host a conference call and webcast today, August 8, 2023, at 8:30 a.m. ET, to discuss its financial results and business update. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 446072 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com. The archived webcast replay will be available for 30 days following the call.