ABEONasdaq

ABEONA THERAPEUTICS INC.

Pharmaceutical Preparations · DE · CIK 318306

Developing and commercializing cell and gene therapies for life-threatening genetic diseases

red 8-K · 90d

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$315M

Market cap

$5.66

Last close

+0.9%

-1.6%

1.3M

Volume

Price · last 39 sessions-4.9%

May 4L $5.12 · H $6.01Jun 29

383

Total filings

Jun 12, 2026

Last filing

12/31

Fiscal year end

All 8-K · 198 10-Q · 55 SC 13G · 24 DEF 14A · 21 S-1/A · 19 424B5 · 19 10-K · 19 8-K/A · 9

Insider Activity

In the 90 days to Mar 31, 2026: 9 sold $1.2M.

Date	Insider	Action	Shares	Price	Value
Mar 31, 2026	Seshadri VishwasChief Executive Officer	Sell	29,985	$4.38	$131K
Mar 16, 2026	Vazzano Joseph WalterChief Financial Officer	Sell	785	$4.76	$4K
Feb 2, 2026	Silverstein Christine BerniDirector	Sell	20,070	$5.09	$102K
Feb 2, 2026	Alland LeilaDirector	Sell	18,065	$5.09	$92K
Feb 2, 2026	Crombez EricDirector	Sell	16,284	$5.09	$83K
Feb 2, 2026	Wuchterl Donald A.Director	Sell	14,814	$5.09	$75K
Feb 2, 2026	Alvino MarkDirector	Sell	2,000	$5.09	$10K
Jan 22, 2026	Seshadri VishwasChief Executive Officer	Sell	69,832	$5.33	$372K
Jan 22, 2026	Vazzano Joseph WalterChief Financial Officer	Sell	18,666	$5.33	$99K
Jan 22, 2026	O'Malley Brendan M.SVP, Chief Legal Officer	Sell	13,578	$5.33	$72K
Jan 22, 2026	Vasanthavada MadhavChief Commercial Officer	Sell	12,610	$5.29	$67K
Jan 21, 2026	Alvino MarkDirector	Sell	13,500	$5.23	$71K
Dec 29, 2025	Seshadri VishwasChief Executive Officer	Sell	25,000	$5.31	$133K
Nov 13, 2025	Alvino MarkDirector	Sell	15,000	$4.74	$71K
Oct 16, 2025	Seshadri VishwasChief Executive Officer	Sell	249	$5.49	$1K
Sep 30, 2025	Seshadri VishwasChief Executive Officer	Sell	25,000	$5.24	$131K
Sep 29, 2025	Seshadri VishwasChief Executive Officer	Sell	19,274	$5.39	$104K
Sep 29, 2025	O'Malley Brendan M.SVP, Chief Legal Officer	Sell	9,366	$5.39	$50K
Sep 29, 2025	Vazzano Joseph WalterChief Financial Officer	Sell	9,035	$5.39	$49K

Open-market buys & sells (Form 4, transaction codes P/S). Source: SEC structured insider data.

What Changed

Risk factors · Mar 20, 2025 → Mar 17, 2026

102 added · 111 removed between the two most recent 10-Ks. The risks a company starts — or stops — disclosing are often the story.

Newly disclosed

For example, we manufactured a full batch of ZEVASKYN ® following patient biopsy collection in August 2025 that, despite being a 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 yielded a false positive result for sterility.
Failure to comply with current and future laws and regulations could result in government enforcement actions (including the imposition of significant penalties), criminal and/or civil liability for us and our officers and directors, private litigation and/or adverse publicity that negatively affects our business. 36 Trends toward managed health care, health technology assessment, and downward price pressures on medical products and services may limit our ability to profitably sell any drugs that we may develop.
Foreign governments may also adopt non-tariff measures, such as procurement preferences or informal disincentives to engage with, purchase from or invest in U.S. entities, which may limit our ability to compete internationally and attract non-U.S. investment, employees, customers and suppliers.
Disruptions at FDA and other agencies may also increase the time necessary to meet with and provide feedback to entities developing drug products, review and/or approve our submissions, conduct inspections, issue regulatory guidance, or otherwise authorize our actions requiring regulatory approval, which would adversely affect our business.
The commercialization of ZEVASKYN ® exposes us to the risk of product liability claims and other litigation, including claims related to adverse events, off-label promotion, false advertising, pricing, or reimbursement practices.
Although we resumed biopsy collection in November 2025 upon completion of assay optimization and the necessary regulatory submission for its implementation, this false positive caused a manufacturing rejection, which caused a delay in our launch of ZEVASKYN ® .
Even if we are successful in defending ourselves against such claims, litigation could be costly, time-consuming, and damaging to our reputation.
Our commercialization efforts may expose us to increased risk of product liability and other litigation.
Moreover, California adopted the California Consumer Privacy Act of 2018 (“CCPA”), which went into effect in January 2020.
RISK FACTOR SUMMARY Our business is subject to numerous risks and uncertainties, including those described in Item 1A “Risk Factors.” These risks include, but are not limited to the following: ● We may not be able to successfully manufacture or commercialize ZEVASKYN ® and the revenue that we generate from its sales, if any, may be limited. ● Our financial performance depends on the commercial success of ZEVASKYN ® and we have limited experience as a commercial-stage company. ● We may encounter challenges with engaging or coordinating with qualified treatment centers needed for the ongoing commercialization of ZEVASKYN ® . ● Our cell and gene therapy product candidates are based on proprietary methodologies, which makes it difficult to predict the time and cost of product candidate development and regulatory approval.
Additionally, regulatory requirements governing cell and gene therapy products have evolved and may continue to change in the future. ● We may encounter substantial delays in our clinical studies, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
Risks Related to the Commercialization of ZEVASKYN ® and our Ability to Generate Revenue We are in the early stages of commercializing ZEVASKYN ® and our limited operating history as a commercial-stage company makes it difficult to predict the long-term success of our business.

No longer disclosed

For example, in September 2019, we received a clinical hold letter in connection with our phase 3 clinical trial for pz-cel stating that the FDA would not provide approval for us to begin our planned phase 3 clinical trial for pz-cel until we submitted additional data points on transport stability of pz-cel to clinical sites.
For example, for product candidates that we develop and commercialize on our own, we remain responsible for ensuring that each of our IND-enabling studies and clinical studies are conducted in accordance with the study plan and protocols, and that our viral vectors and drug products are manufactured in accordance with GMP as applied in the relevant jurisdictions.
Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development or publication of information including our trade secrets in cases where we do not have proprietary or otherwise protected rights at the time of publication.
Nearly all clinical trials involve the processing of these “special categories” of personal data, and thus processing of personal data collected during the course of clinical trials is subject to heightened protections under GDPR. 44 Moreover, California adopted the California Consumer Privacy Act of 2018 (“CCPA”), which went into effect in January 2020.
Although the FDA removed the clinical hold in December 2019 and provided clearance for us to proceed with our planned phase 3 clinical trial, we may encounter similar delays in our clinical studies in the future.
For example, our product candidates may compete with other products and product candidates for access to manufacturing facilities.
In August 2024, we completed a Type A Meeting with the FDA to discuss our forthcoming resubmission of our BLA and in October 2024, we resubmitted our BLA.
The FDA notified the Company in November 2024 that the BLA was accepted for review, with an assigned PDUFA target action date of April 29, 2025.
RISK FACTOR SUMMARY Our business is subject to numerous risks and uncertainties, including those described in Item 1A “Risk Factors.” These risks include, but are not limited to the following: ● Our cell and gene therapy product candidates are based on proprietary methodologies, which makes it difficult to predict the time and cost of product candidate development and regulatory approval.
Additionally, regulatory requirements governing cell and gene therapy products have evolved and may continue to change in the future. ● If we do not obtain the necessary U.S. or worldwide regulatory approvals to commercialize pz-cel, we will not be able to sell pz-cel. ● Even if we receive regulatory approval for pz-cel, our lead drug candidate, we may not be able to successfully manufacture or commercialize the product and the revenue that we generate from its sales, if any, may be limited. ● We may encounter substantial delays in our clinical studies, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
We may also experience delays in developing a sustainable, reproducible and commercial-scale manufacturing process or transferring that process to commercial partners, which may prevent us from completing our clinical studies or commercializing our products on a timely or profitable basis, if at all. 28 In addition, the clinical study requirements of the FDA, the EMA, and other regulatory agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential products.
Further, the cost of compliance with post-approval regulations may have a negative effect on our operating results and financial condition. 34 The Complete Response Letter related to our Biologics License Application for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa may impair our ability to successfully commercialize pz-cel.

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