ABEOHIGH SIGNALREGULATORY10-K

Abeona has achieved FDA approval for ZEVASKYN, its gene therapy for rare skin disease RDEB, marking a transition from clinical development to commercial operations.

This represents a major milestone as ZEVASKYN becomes the first and only FDA-approved treatment for RDEB wounds, positioning Abeona to generate revenue from this orphan indication. However, the approval comes amid deteriorating financial performance, suggesting significant commercial execution challenges ahead. The company has shifted focus from its broader pipeline development to concentrate on this newly approved therapy.

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FINANCIAL ANALYSIS

Abeona's financial position weakened substantially during the period, with operating losses expanding meaningfully to $89.4M while current liabilities grew notably to $29.6M. Operating cash outflows increased significantly to $76.3M, though R&D expenses declined modestly to $26.8M, likely reflecting the completion of clinical development for the now-approved ZEVASKYN. The financial deterioration coinciding with FDA approval suggests the company faces considerable funding and commercialization pressures despite achieving this regulatory milestone.

FINANCIAL STATEMENT CHANGES
Current Liabilities
Balance Sheet
+78.3%
$16.6M→$29.6M

Current liabilities surged 78.3% — significant near-term obligations; verify ability to meet short-term debt.

Operating Income
P&L
-39.3%
-$64.2M→-$89.4M

Operating income deteriorated sharply — investigate whether driven by one-time charges or structural cost issues.

Operating Cash Flow
Cash Flow
-36.3%
-$56.0M→-$76.3M

Operating cash flow fell 36.3% — earnings quality concerns; investigate working capital changes and non-cash items.

R&D Expense
P&L
-22%
$34.4M→$26.8M

R&D spending cut 22% — could signal cost discipline or concerning reduction in innovation investment.

LANGUAGE CHANGES
NEW — 2026-03-17
PRIOR — 2025-03-20
ADDED
trade policy, including current or future tariffs or other trade restrictions.
This Form 10-K includes our trademarks, trade names and service marks, such as ZEVASKYN and AIM , which are protected under applicable intellectual property laws and are the property of Abeona Therapeutics Inc.
Solely for convenience, trademarks, trade names and service marks referred to in this report appear without the and symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks.
We do not intend our use or display of other parties trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.
Food and Drug Administration ( FDA ) approved ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, also known as ZEVASKYN , as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa ( RDEB ), a serious and debilitating genetic skin disease.
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REMOVED
These statements include statements about: the outcome and timing of the U.S.
Our lead clinical program is for prademagene zamikeracel ( pz-cel ), an autologous, cell-based gene therapy currently in development for recessive dystrophic epidermolysis bullosa ( RDEB ).
Pz-cel has been granted Orphan Drug and Rare Pediatric Disease ( RPD ) designations by the U.S.
Food and Drug Administration ( FDA ) and Orphan Drug Designation by the European Medicines Agency ( EMA ).
We plan to continue development of adeno-associated virus ( AAV ) based gene therapies designed to treat ophthalmic diseases with high unmet need using the novel AIM capsids exclusively licensed from the University of North Carolina at Chapel Hill ( UNC ) and developed internally through our AAV vector research programs.
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