ABEO 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• We are a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s ZEVASKYN® (“prademagene zamikeracel”) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic …

• On July 21, 2026, we announced activation of Cincinnati Children’s as the newest qualified treatment center for the administration of ZEVASKYN. This represents the seventh available qualified treatment center for the administration of ZEVASKYN.

• Comparison of Three Months Ended June 30, 2026 and June 30, 2025

• Product revenue, net, resulting from the sale of ZEVASKYN, for the three months ended June 30, 2026 was $11.4 million. There was no product revenue for the three months ended June 30, 2025 as the approval by the FDA for ZEVASKYN occurred in April of 2025 and we recorded our first sale in December of…

• License and other revenues for the three months ended June 30, 2026 was nil as compared to $0.4 million for the same period of 2025. The revenue in 2025 of $0.4 million consists of revenue resulting from a third party exercising its option to license certain of our AAV capsids.

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• We are a commercial-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. On April 28, 2025, the FDA approved ZEVASKYN® (prademagene zamikeracel) gene-modified cellular sheets, as the first and only autologous cell-based gene therapy for the treatment of w…

• ZEVASKYN® is manufactured at our cGMP manufacturing facility in Cleveland, Ohio, and is made available through ZEVASKYN® qualified treatment centers.

• On April 2, 2026, we announced activation of NewYork-Presbyterian/Columbia University Irving Medical Center in New York City as another qualified treatment center for the administration of ZEVASKYN®.

• On May 11, 2026, we announced activation of Children’s Hospital of Philadelphia as the newest qualified treatment center for the administration of ZEVASKYN®. This represents the sixth available qualified treatment center for the administration of ZEVASKYN®.

• Building on our proven end-to-end competency in engineered cell therapy, we will focus our development efforts on the development of ABO-701, a recently licensed radically novel engineered T-cell therapy, targeting Prostate-Specific Membrane Antigen (“PSMA”) to treat prostate cancer. PSMA is a valid…

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• The manufacturing, testing and delivery of ZEVASKYN® present significant challenges for us, and we may not be able to produce ZEVASKYN® at the quality, quantities, or timing needed to support commercialization.

• The manufacturing of ZEVASKYN® is complex and requires significant expertise. Even with the relevant experience and expertise, manufacturing cell therapy products often leads to difficulties in production, particularly in scaling out and validating initial production, managing the transition from cl…

• We are susceptible to production interruptions that may impede our ability to manufacture cell and gene therapy products and produce an adequate product supply to support commercialization of ZEVASKYN®. Several factors could cause production interruptions, including equipment malfunctions, facility …

• For example, we manufactured a full batch of ZEVASKYN® following patient biopsy collection in August 2025 that, despite being bonafide drug product, could not be released because a rapid sterility assay, mandated by the FDA as a release assay during the final stage of the BLA review, initially yield…

• We also manufactured a batch of ZEVASKYN® following patient biopsy collection in July 2026 that, despite being bonafide drug product, could not be released because a cellular identity test, mandated by the FDA as a release assay during the final stage of BLA review, was out of specification. The FDA…

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• On January 21, 2026, Joseph Vazzano, the Company’s chief financial officer, adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of all net vested shares issued to Mr. Vazzano upon the vesting of 99,036 restricted stock awards. The duration of the arrangement is until A…

• On February 4, 2026, Eric Crombez, M.D., a member of the Company’s board of directors, adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of an aggregate of up to 63,456 shares of our common stock. The duration of the arrangement is until May 7, 2027, or the date on w…