Abeona Therapeutics Announces Q1 2024 Financial Results and Corporate Updates

Abeona Therapeutics Inc. announced its financial results for the first quarter of 2024 and highlighted recent corporate progress. The company, which trades under the Nasdaq ticker ABEO, has extended its cash runway into 2026 following a $75 million underwritten securities offering in May 2024. CEO Vish Seshadri expressed gratitude for the support from both existing and new investors and emphasized the company’s focus on addressing regulatory requirements.

Corporate achievements for the quarter include closing the $75 million underwritten offering on May 7, 2024, and securing a $50 million credit facility in January 2024, of which $20 million has been received.

Regarding prademagene zamikeracel (pz-cel) for recessive dystrophic epidermolysis bullosa (RDEB), Abeona received a Complete Response Letter (CRL) from the FDA in April 2024, indicating the need for additional Chemistry Manufacturing and Controls (CMC) data before approving the Biologics License Application (BLA). The FDA did not point out any deficiencies related to the clinical efficacy or safety data and did not request new clinical trials. Abeona plans to resubmit the BLA in the second half of 2024.

New long-term safety data for pz-cel, which includes follow-up of up to 11 years, has been accepted for presentation at the Society for Investigative Dermatology Annual Meeting happening from May 15-18, 2024. Additionally, Abeona is preparing for the potential U.S. commercial launch of pz-cel by engaging with treatment sites, medical professionals, and payers, as well as building necessary supply chain and enterprise capabilities.

Financially, Abeona reported cash, cash equivalents, restricted cash, and short-term investments totaling $62.7 million as of March 31, 2024, a rise from $52.6 million at the end of 2023. Net cash used in operating activities for the first quarter was $14.5 million. The company estimates that its current financial resources, bolstered by the credit facility and the proceeds from the underwritten offering, will be adequate to fund operations into 2026.

For the first quarter of 2024, research and development expenses were $7.2 million, slightly down from $8.0 million during the same period in 2023. General and administrative expenses, however, increased to $7.1 million from $4.0 million in the first quarter of 2023. The net loss for the first quarter of 2024 was $31.6 million, translating to a loss of $1.16 per common share, which includes changes in the fair value of warrant liabilities. This is an increase from the net loss of $9.1 million or $0.54 per common share reported in the first quarter of 2023.

Abeona Therapeutics Inc. is dedicated to developing cell and gene therapies for severe diseases. Their investigational product pz-cel is being developed for RDEB and has completed Phase 3 trials. The company’s manufacturing facility, which produced the pz-cel used in trials, stands ready to support commercial production pending FDA approval. Abeona’s development pipeline also includes AAV-based gene therapies aimed at treating ophthalmic diseases with high unmet needs.

The company will conduct a conference call and webcast on May 15, 2024, at 8:30 a.m. ET to discuss these first-quarter results, accessible through the Investors & Media section of their website.