ABEO: On Track to File BLA in 3Q23...
NASDAQ:ABEO
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Business Update
BLA Filing for EB-101 on Track for 3Q23
Abeona Therapeutics, Inc. (NASDAQ:ABEO) is developing EB-101, an autologous cell therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). In November 2022, Abeona announced positive topline results from the Phase 3 VIITAL™ study showing EB-101 met the two co-primary endpoints while exhibiting a clean safety and tolerability profile. In May 2023, Abeona announced additional data from the Phase 3 VIITAL™ study, including data showing EB-101 improved would healing in as early as six weeks, a significant reduction in pain for EB-101-treated wounds compared to control wounds, and numerous quality of life improvements. For a full discussion of the Phase 3 VIITAL data please see our initiation report (here) and our previous update (here).
During the second quarter conference call, Abeona’s management indicated that the company has completed the process performance qualification manufacturing runs for both the retroviral vector (RVV) and EB-101 drug product. These manufacturing runs were designed to show that the manufacturing process for EB-101 is robust and ready for commercial production. In addition, the FDA had requested additional data supporting the comparability between the two RVV sources used in EB-101 clinical studies. Both of those sets of data will be included in the chemistry, manufacturing, and controls (CMC) module for the BLA submission. Abeona has submitted the briefing package for the pre-BLA meeting with the FDA in August 2023. This should set the company up for filing the BLA in the third quarter of 2023.
Financial Update
On August 8, 2023, Abeona announced financial results for the second quarter of 2023. The company reported $3.5 million in license and other revenues in the second quarter of 2022 compared to $1.0 million for the second quarter of 2022. The revenue in both periods resulted from clinical milestones achieved under a sublicense agreement with Taysha Gene Therapies in October 2020 relating to an investigational AAV-based gene therapy for Rett syndrome. Royalties for the second quarter of 2023 were $1.6 million compared to $0.4 million for the second quarter of 2022. The increase was due to royalties the company owed to its licensors resulting from the milestone due from Taysha related to Rett syndrome.
R&D expenses in the second quarter of 2023 were $8.5 million compared to $6.7 million for the second quarter of 2022. The increase was primarily due to increased clinical costs, salaries, and other costs. G&A expenses in the second quarter of 2023 were $5.0 million compared to $3.4 million for the second quarter of 2022. The increase was primarily due to increased salaries, non-cash stock-based compensation, professional fees, and other costs.
Abeona exited the second quarter of 2023 with approximately $36.8 million in cash, cash equivalents, and investments. Subsequent to the end of the quarter, the company raised $25 million in gross proceeds from a registered direct offering. Following the offering, we estimate the company has sufficient capital to fund operations into the fourth quarter of 2024. As of August 1, 2023, the company had approximately 24.8 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 37.0 million.
Conclusion
We are glad to see that the company remains on track to file the BLA for EB-101 in the third quarter of 2023 and we look forward to continued updates from the company regarding the acceptance of the BLA and other news during the review process. We remind investors that approval of EB-101 could be accompanied by issuance of a priority review voucher (PRV), which is likely to sell in the $100 million range based on sales of PRV’s over the past three years. Following the recent financing our valuation now stands at $8.00.
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