Abeona Therapeutics’ Earnings Call Highlights ZEVASKYN Success

Abeona Therapeutics Inc ((ABEO)) has held its Q1 earnings call. Read on for the main highlights of the call.

Abeona Therapeutics Inc recently held its earnings call, which conveyed a generally positive sentiment, underscored by the successful FDA approval of ZEVASKYN and a favorable market reception. The call highlighted strategic financial maneuvers aimed at ensuring the company’s stability, though it also acknowledged challenges such as delays in patient treatment and increased operating expenses.

FDA Approval of ZEVASKYN

Abeona Therapeutics celebrated a significant milestone with the FDA approval of ZEVASKYN, marking it as the first and only autologous cell-based gene therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB). This approval represents a pivotal advancement in the treatment landscape for this rare genetic disorder.

First Qualified Treatment Center Activated

The company announced the activation of Lurie Children’s Hospital of Chicago as the first Qualified Treatment Center for ZEVASKYN. This development is crucial for patient identification and scheduling, paving the way for the therapy’s practical application.

Strong Initial Market Response

In the weeks following ZEVASKYN’s approval, Abeona Assist, the company’s patient hub, received inquiries from approximately 30 patients and families across the United States, indicating a robust initial market interest and demand for the therapy.

Positive Financial Outlook

Abeona’s financial outlook appears promising, with the sale of a Priority Review Voucher (PRV) for $155 million expected to fund operations for over two years. This strategic move extends the company’s financial runway through to projected profitability in early 2026.

Outcomes-Based Agreements Executed

The execution of outcomes-based agreements with two payer contracting organizations is set to enhance patient access to ZEVASKYN, potentially broadening the therapy’s reach and impact.

Positive Clinical Data Presentation

At the Society for Investigative Dermatology annual meeting, Abeona presented two late-breaking abstracts that underscored ZEVASKYN’s efficacy and safety, further solidifying its clinical credibility.

Delayed Initial Patient Treatment

Despite the positive developments, the company noted a delay in the initial patient treatment with ZEVASKYN at Lurie Children’s, now expected in the third quarter of 2025, suggesting a slower rollout than initially anticipated.

Increased Operating Expenses

Abeona reported an increase in research and development expenses, rising to $9.9 million in Q1 2025 from $7.2 million in Q1 2024, attributed to scale-up activities associated with ZEVASKYN’s launch.

Net Loss for the Quarter

The company reported a net loss of $12 million for the first quarter of 2025, an improvement from the $31.6 million loss in the same period of 2024, reflecting better financial management and strategic planning.

Forward-Looking Guidance

Abeona provided forward-looking guidance during the earnings call, focusing on the commercial launch of ZEVASKYN. The company highlighted the activation of the first Qualified Treatment Center and the strong demand indicated by patient inquiries. Financial projections include cash and equivalents of $84.5 million as of March 31, 2025, and expected net proceeds from the PRV sale, which will support operations for over two years. Abeona aims to treat 10 to 14 patients in 2025 and achieve profitability by early 2026, bolstered by outcomes-based agreements with major payer organizations.

In summary, Abeona Therapeutics’ earnings call painted a picture of optimism, fueled by the FDA approval of ZEVASKYN and strategic financial decisions. While challenges such as treatment delays and increased expenses were noted, the company’s forward-looking guidance and market reception suggest a promising trajectory toward profitability and expanded patient access.