Abeona Therapeutics Earnings Call: Positive Outlook Amid Challenges

Abeona Therapeutics Inc ((ABEO)) has held its Q3 earnings call. Read on for the main highlights of the call.

Abeona Therapeutics Inc. recently held an earnings call that conveyed a generally positive outlook, highlighting strong advancements in the commercial launch of ZivaSkin, expansion of treatment centers, and favorable market access. Despite these positive developments, the company faces challenges such as delays in patient treatment and increased SG&A expenses. Nonetheless, Abeona’s financial position remains robust, and its pipeline shows promising advancements.

ZivaSkin Commercial Launch Progress

The commercial launch of ZivaSkin is gaining momentum, with patient demand on the rise. The company has received product order forms for 12 patients, and the number of identified eligible patients at qualified treatment centers has more than doubled to approximately 30. This indicates a growing acceptance and demand for ZivaSkin in the market.

Expansion of Qualified Treatment Centers

Abeona Therapeutics is expanding its network of qualified treatment centers, with Children’s Hospital Colorado recently added as a new center. This brings the total number of centers to three, and discussions are ongoing with other centers to further expand the network, which is crucial for increasing patient access to ZivaSkin.

Strong Market Access for ZivaSkin

The company has secured positive coverage decisions from major commercial and government payers, covering over 80% of commercially insured lives. ZivaSkin now has baseline coverage across all state Medicaid programs, and a permanent product J code will be effective from January 2026, facilitating reimbursement processes and enhancing market access.

Financial Stability

Abeona Therapeutics maintains a strong financial position with a cash reserve of $207.5 million, expected to fund operations for over two years without anticipated revenue from ZivaSkin. The company reported a significant decrease in net loss to $5.2 million from $30.3 million in the previous year, underscoring its financial resilience.

Pipeline Advancements

The company’s gene therapy program for X-linked retinoschisis is part of the FDA Rare Disease Endpoint Advancement pilot program. Additionally, Dr. James A. Gao has been appointed as Senior Vice President, Head of Clinical Development and Medical Affairs, signaling a commitment to advancing its pipeline.

Delay in First Patient Treatment

The first patient treatment for ZivaSkin has been delayed to 2025 due to a performance issue in a release assay, which required optimization and regulatory submissions. This delay poses a challenge to the company’s timeline for patient treatments.

Increased SG&A Expenses

Abeona reported an increase in selling, general, and administrative expenses to $19.3 million from $6.4 million in the previous year. This increase reflects reclassified R&D expenses and increased headcount and professional costs, which are necessary for supporting the company’s growth.

Temporary Manufacturing Pause

A temporary pause in patient biopsies was implemented to ensure product quality, impacting the timeline for patient treatments. This pause underscores the company’s commitment to maintaining high product quality standards.

Forward-Looking Guidance

During the earnings call, Abeona Therapeutics provided guidance on its ZivaSkin launch, emphasizing key metrics. The company highlighted growing patient demand, with 12 ZivaSkin Product Order Forms received and approximately 30 eligible patients identified at Qualified Treatment Centers. The expansion of the QTC network to three centers, including Children’s Hospital Colorado, was also noted. On the market access front, ZivaSkin gained coverage from major commercial payers covering over 80% of insured lives and now has baseline coverage across all 51 state Medicaid programs. Financially, Abeona reported a net loss of $5.2 million for the quarter, with cash and investments totaling $207.5 million as of September 30, 2025, expected to fund operations for over two years.

In summary, Abeona Therapeutics’ earnings call reflected a positive sentiment with significant progress in the commercial launch of ZivaSkin and expansion of treatment centers. Despite challenges such as delays in patient treatment and increased expenses, the company’s financial stability and promising pipeline advancements position it well for future growth. Investors and stakeholders can remain optimistic about Abeona’s strategic direction and market potential.