ABEO — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-13

• 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…

• ABO-701 is an autologous engineered T-cell product that carries a Synthetic Immune Receptor (“SIR-T™”) designed to overcome the limitations of CAR and TCR approaches. The SIR-T™ platform underlying ABO-701 was developed in the laboratory of Preet M. Chaudhary, M.D., Ph.D., Professor of Medicine and …

• We expect to file an Investigational New Drug (“IND”) application and commence first-in-human studies with ABO-701 in the second half of 2027 while engaging a contract development and manufacturing organization for supply readiness in the meantime. This development plan and timing allow us to mainta…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• Our development portfolio also features adeno-associated virus (“AAV”) based gene therapies designed to treat ophthalmic diseases with high unmet need using novel AIM™ capsids. Abeona’s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating di…

• Our preclinical programs are investigating the use of novel AAV capsids in AAV-based therapies for serious genetic eye diseases, including ABO-504 for Stargardt disease, ABO-503 for X-linked retinoschisis (“XLRS”) and ABO-505 for autosomal dominant optic atrophy (“ADOA”). We completed pre-Investigat…

• During the third quarter, we manufactured a full batch of drug product following patient biopsy collection in August 2025. Although we produced bonafide drug product, it could not be released because a rapid sterility assay, mandated by the FDA as a release assay during the final stage of the Biolog…

• On October 8, 2025, we announced the activation of the newest QTC for ZEVASKYN® at Children’s Hospital Colorado. As a result, RDEB patients will be able to access ZEVASKYN® at Lucile Packard Children’s Hospital Stanford, Lurie Children’s Hospital of Chicago and Children’s Hospital Colorado.

• On October 13, 2025, we announced that ABO-503 for XLRS was selected by the FDA for Rare Disease Endpoint Advancement Pilot (“RDEA”) Program. The RDEA program facilitates the development and timely approval of rare disease therapies by supporting the use of novel efficacy endpoints in clinical trial…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operations.

• The U.S. government has announced substantial new tariffs affecting a wide range of products and jurisdictions and has indicated an intention to continue developing new trade policies, including with respect to the pharmaceutical industry. In response, certain foreign governments have announced or i…

• Current or future tariffs or other trade restrictions may result in increased research and development expenses, including with respect to increased costs associated with raw materials, laboratory equipment, and research materials and components. In addition, such tariffs may increase our supply cha…

• If we are unable to obtain necessary raw materials or product components in sufficient quantity and in a timely manner due to disruptions in the global supply chain caused by macroeconomic events and conditions, the development, testing and clinical trials of our product candidates may be delayed or…

• The complexity of announced or future tariffs may also increase the risk that we or our customers or suppliers may be subject to civil or criminal enforcement actions in the United States or foreign jurisdictions related to compliance with trade regulations. Foreign governments may also adopt non-ta…

Text added vs the prior filing · source: 10-Q · 2026-05-13

• During the three months ended March 31, 2026, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted, modified or terminated any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense…

• 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…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• During the fiscal quarter ended September 30, 2025, none of our directors or officers (as defined in Rule 16a-1 under the Exchange Act) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 105b-1 trading arrangement” (as those terms are defined in Item 408 of Regulation S…