On November 9, 2026 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported third-quarter 2026 financial results and provided an update on the commercial launch of ZEVASKYN.

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"Maximizing the opportunity for ZEVASKYN remains our number one priority. During the third quarter, we continued to build the commercial foundation for ZEVASKYN, with expansion of our QTC network and more centers gaining firsthand treatment experience," said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona Therapeutics. "The acquisition of APT-1011 represents an important step in building Abeona into a diversified commercial-stage company, adding a uniquely differentiated late-stage orphan-drug asset with substantial commercial potential in a rapidly growing disease with high unmet need."

ZEVASKYN Commercial Update

ZEVASKYN treatment activity increased in the third quarter. Since launch, 15 patient treatments have been completed with ZEVASKYN, including six during the third quarter of 2026.

Broader qualified treatment center (QTC) participation supported increased ZEVASKYN treatment activity. Abeona expanded its national ZEVASKYN QTC network to eight sites during the third quarter, increasing geographic access for eligible patients:

Children’s Hospital of Philadelphia and the University of Texas Medical Branch completed their first ZEVASKYN patient treatments during the third quarter, increasing the number of QTCs with treatment experience from two to four.
University of Florida (UF) Health in Gainesville, Florida, was activated in September 2026 as the eighth ZEVASKYN QTC, expanding access for eligible pediatric and adult RDEB patients in Florida and the Southeastern U.S.
Cincinnati Children’s, one of the largest epidermolysis bullosa treatment centers in the U.S., was activated as a ZEVASKYN QTC in July 2026.

New Technology Add-On Payment (NTAP) status for ZEVASKYN became effective October 1, 2026. Under the Centers for Medicare & Medicaid Services (CMS) fiscal year 2027 Hospital Inpatient Prospective Payment System Final Rule. Under the standard NTAP pathway, qualifying technologies must be new and meaningfully differentiated from existing technologies, meet CMS cost criteria, and demonstrate substantial clinical improvement relative to existing treatments. NTAP provides a pathway for eligible hospitals to receive supplemental reimbursement, in addition to the diagnosis-related group base payment, when treating eligible Medicare beneficiaries with ZEVASKYN. This designation is expected to help support patient access and hospital adoption among eligible Medicare beneficiaries, who represent approximately 10 percent of RDEB patients.

Corporate and Pipeline Developments

Abeona acquired APT-1011, now ABO-801, from Ellodi Pharmaceuticals and announced a $30 million PIPE financing. In a separate press release issued today, Abeona announced the acquisition of ABO-801, a Phase 3-ready, once-daily oral disintegrating tablet formulation of fluticasone propionate in development for EoE. Under the terms of the asset purchase agreement, Abeona has issued to Ellodi $20 million of Abeona common stock at closing, with no upfront cash consideration. Ellodi is also eligible to receive payments of $30 million upon FDA approval of ABO-801 and up to an additional $30 million upon achievement of specified sales milestones. In addition, Ellodi is eligible to receive tiered royalties on net sales of ABO-801 ranging from low to mid teen percentages.

Also announced in a separate press release issued today, Abeona entered into a securities purchase agreement for a private placement of $30 million in gross proceeds before fees and expenses. The Company intends to use the net proceeds from the private placement for general corporate purposes, including funding the development of the Company’s product candidate pipeline and supporting commercialization efforts for ZEVASKYN.

Ultragenyx secures U.S. FDA approval of FAYUVI. In September, Ultragenyx Pharmaceutical Inc. received FDA approval of FAYUVI (rebisufligene etisparvovec-hopf) gene therapy for Sanfilippo Syndrome Type A (MPS IIIA). Abeona previously advanced the program before licensing it to Ultragenyx in May 2022. Pursuant to its licensing agreement with Ultragenyx, Abeona is eligible to receive certain commercial milestone payments and tiered royalties of up to 8 percent on future product sales.

Third Quarter 2026 Financial Results

Net ZEVASKYN revenue for the quarter ended September 30, 2026 was $13.5 million, an 18% increase compared with $11.4 million for the second quarter of 2026. As previously disclosed in August 2026, revenue was not recognized for one treatment in the third quarter because the associated batch did not meet the release criterion for the identity assay.

Cost of sales was $5.7 million for the third quarter of 2026, compared with $4.2 million for the second quarter of 2026.

Research and development expenses were $3.7 million for the third quarter of 2026, compared with $5.0 million for the second quarter of 2026.

Selling, general and administrative expenses were $17.1 million for the third quarter of 2026, compared with $15.8 million for the second quarter of 2026.

Net loss was $(4.8) million, or $(0.08) per basic and diluted common share, for the quarter ended September 30, 2026, compared with a net loss of $(20.2) million, or $(0.35) per basic and diluted common share, for the second quarter of 2026.

Cash, cash equivalents and short-term investments totaled $134.9 million as of September 30, 2026, compared with $146.8 million as of June 30, 2026. The September 30, 2026 balance excludes the $30 million in gross proceeds from the private placement financing completed after quarter end.

Conference Call Details

The Company will host a conference call and webcast on November 9, 2026, at 8:30 a.m. ET to discuss the third-quarter financial results, ZEVASKYN commercial progress and the acquisition of ABO-801 and PIPE financing. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 208009 five minutes prior to the start of the call. A live, listen-only webcast can be accessed on the Investors & Media section of Abeona’s website at View Source An archived webcast replay will be available for 30 days following the call.

(Press release, Abeona Therapeutics, NOV 9, 2026, View Source [SID1234674458])