Abeona Therapeutics Inc (ABEO, Financial) released its 8-K filing on November 13, 2023, detailing the company's financial results for the third quarter of 2023 and providing updates on corporate developments. The company has made significant strides in transitioning from a late-stage clinical development company to one poised for commercial opportunities, particularly with its lead clinical program, pz-cel, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Commercial Progress and Financial Highlights
In the third quarter, Abeona submitted a Biologics License Application (BLA) to the FDA for pz-cel, marking a critical step towards potential approval. The FDA's decision on priority review and acceptance of the BLA is anticipated by late November 2023. If granted Priority Review, approval could come as early as the second quarter of 2024. To support the potential launch, Abeona raised $25 million through a registered direct offering and initiated commercial readiness activities, including engaging with EB treatment sites and payers.
Financial Performance
Abeona's financial reserves, including cash, cash equivalents, restricted cash, and short-term investments, totaled $54.1 million as of September 30, 2023. This represents an increase from $37.1 million as of June 30, 2023, and is expected to fund operations into the fourth quarter of 2024. Research and development expenses for Q3 2023 were $7.1 million, up from $5.5 million in the same period of 2022. General and administrative expenses also saw an increase to $4.2 million from $3.9 million year-over-year. The net loss attributable to common shareholders for the quarter was $11.8 million, or a loss of $0.48 per common share, compared to a net loss of $6.4 million, or $1.00 loss per common share, in Q3 2022.
Conference Call and Webcast
Abeona Therapeutics hosted a conference call and webcast on the same day as the filing to discuss the financial results and developments. The webcast is available on the Investors & Media section of Abeona’s website and will be archived for 30 days following the call.
Looking Ahead
The company's focus remains on the potential approval and launch of pz-cel, while also advancing its portfolio of cell and gene therapies for serious diseases. Abeona continues to evaluate its novel AAV capsids for a variety of diseases and maintains a fully integrated cell and gene therapy manufacturing facility capable of supporting clinical and potential commercial production.
For detailed financial tables and further information, readers are encouraged to view the full 8-K filing.
Explore the complete 8-K earnings release (here) from Abeona Therapeutics Inc for further details.
