Abeona Therapeutics® Reports Full Year 2025 Financial Results and Corporate Updates

On March 17, 2026 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for the full year of 2025 and recent operational progress.

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"2026 is about building a steady cadence of biopsies and treatments," said Vish Seshadri, Chief Executive Officer of Abeona. "We are focused on ensuring every ZEVASKYN patient has a seamless experience throughout their treatment journey. Establishing these commercial foundations will position us to scale-up ZEVASKYN in 2026 and beyond."

ZEVASKYN (prademagene zamikeracel) updates

● First ZEVASKYN commercial patient treatment completed in December; launch momentum building in first quarter 2026: Following the optimization of a release assay in 2025, ZEVASKYN commercial launch activities commenced in the fourth quarter, with the first patient treatment completed in December prior to a mandatory annual manufacturing facility shutdown. Since resuming manufacturing in late January 2026, multiple biopsies have been collected with additional biopsies expected this month. One patient has completed treatment with ZEVASKYN so far in 2026, and other collected biopsies are at various stages in the manufacturing process.
● Growing ZEVASKYN treatment experience expected to catalyze further ZEVASKYN demand: Growing ZEVASKYN treatment experience across the initial Qualified Treatment Center (QTC) network is establishing the institutional workflows and scalable foundation necessary to accelerate patient throughput and streamline the referral-to-treatment timeline. As the RDEB community shares in the positive experiences of the initial ZEVASKYN patients, the Company believes this will continue to catalyze sustained demand for ZEVASKYN.
● Abeona expands patient access to ZEVASKYN across Texas and the Gulf Coast region with activation of its newest QTC: In December, the Company announced activation of The University of Texas Medical Branch (UTMB), in Galveston, Texas, as the fourth QTC for ZEVASKYN. UTMB is a major academic medical center renowned for its expertise in comprehensive complex skin disease and wound care.

Full Year 2025 Financial Results

Abeona reported total revenue of $5.8 million for the year ended December 31, 2025. This was comprised of $3.4 million in license and other revenues and $2.4 million in net product revenue. License and other revenues were driven by a clinical milestone reached under the October 2020 sublicense agreement with Taysha Gene Therapies for its investigational Rett syndrome gene therapy.

Net product revenue reflects the single patient treatment in December. While net product revenue reflects Medicaid coverage for the patient treated in December, the Company expects average net revenues to normalize over time as the payer mix expands to include commercially insured patients. Cash was received from the December treatment in the first quarter 2026.

Cost of sales for 2025 was $1.5 million, primarily driven by the first commercial ZEVASKYN treatment in December and costs from an August production batch that was not released due to technical challenges related to the FDA-mandated rapid sterility lot release assay.

Total research and development (R&D) spending for 2025 decreased $7.6 million to $26.8 million, compared to $34.4 million in 2024. This reduction was primarily driven by the April 2025 FDA approval of ZEVASKYN, which resulted in certain production costs being capitalized into inventory and engineering runs that are no longer classified as R&D expense.

Selling, general and administrative (SG&A) expenses for 2025 were $65.0 million, an increase of $35.1 million over 2024. This increase primarily reflects Abeona’s commercial transition following the April 2025 FDA approval of ZEVASKYN, including $18.6 million in personnel and stock-based compensation and $2.3 million in direct commercialization costs. Additionally, certain engineering and training expenses previously classified as R&D were transitioned to SG&A post-approval.

In May 2025, Abeona sold the Rare Pediatric Disease Priority Review Voucher (PRV) awarded following the FDA’s approval of ZEVASKYN. The Company received $155.0 million in gross proceeds from the sale in June 2025, resulting in a $152.4 million gain net of $2.6 million in transaction costs.

Net income was $71.2 million for the year ended December 31, 2025, or $1.34 per basic and $1.01 per diluted common share. Net loss in 2024 was $(63.7) million, or $(1.55) per basic and diluted common share.

Cash, cash equivalents and short-term investments totaled $191.4 million as of December 31, 2025.

Conference Call Details

The Company will host a conference call and webcast on Tuesday, March 17, 2026 at 8:30 a.m. ET to discuss its 2025 financial results and corporate progress. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 977217 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.

(Press release, Abeona Therapeutics, MAR 17, 2026, View Source [SID1234663604])

One-carbon Therapeutics Announces Strategic Collaboration with Tempus to Advance Molecular Insights and Enable Precision Oncology Development of TH9619

On March 17, 2026 One-carbon Therapeutics, a clinical-stage oncology company pioneering first-in-class targeted therapies based on deep understanding into cancer biology, reported a strategic collaboration with Tempus AI Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine. The collaboration will leverage Tempus’ proprietary, de-identified multimodal database and bioinformatics expertise to advance molecular insights supporting the clinical development of TH9619.

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Through this collaboration, One-carbon Therapeutics will utilize Tempus’ analytical services to characterize the expression landscape across prioritized solid tumor indications. By integrating RNA sequencing data with clinical variables, the teams aim to uncover deep molecular insights that will inform the development of TH9619.

"Understanding the molecular dynamics of one-carbon metabolism across tumor types and treatment settings is fundamental to advancing TH9619 with precision," said Ana Slipicevic, Chief Executive Officer at One-carbon Therapeutics. "Tempus’ depth of molecular data and analytical rigor enables us to generate statistically robust evidence that can potentially guide clinical decision making and optimize development."

"At Tempus, our goal is to accelerate progress in oncology by translating complex molecular insights into meaningful therapeutic advances," said Ezra Cohen, MD, Chief Medical Officer, Oncology, at Tempus. "Through comprehensive analysis of our multimodal dataset, we are supporting One-carbon Therapeutics in characterizing the metabolic signatures across diverse tumor types. These insights are essential to informing research strategies and advancing the development of next-generation targeted cancer therapies."

By deepening the understanding of the biological mechanisms and genetic profiles associated with one-carbon metabolism across tumor types, the collaboration will strengthen the precision-driven clinical strategy for TH9619. Building on a deep understanding of how cancer cells depend on this pathway, these analyses may help identify patient populations most likely to benefit from treatment. This approach has the potential to enhance development efficiency, reduce uncertainty and ultimately help ensure that innovative targeted therapies reach the patients who need them most.

(Press release, One-carbon Therapeutics, MAR 17, 2026, View Source [SID1234663621])

GV20 Therapeutics Announces Late-Breaking Oral Presentation of GV20-0251 Translational Findings at the AACR Annual Meeting 2026

On March 17, 2026 GV20 Therapeutics (GV20), a clinical-stage AI-powered biotherapeutics company, reported that it has been selected to deliver a late-breaking oral presentation highlighting translational data of GV20-0251 at the American Association of Cancer Research 2026 Annual Meeting, taking place in San Diego on April 17- 22, 2026.

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This presentation at AACR (Free AACR Whitepaper) builds on previously presented clinical data of the novel immune checkpoint IGSF8 inhibitor GV20-0251 (Wentzel et al, ASCO (Free ASCO Whitepaper) 2025) and will report the translational findings, including pharmacodynamic and potential predictive biomarkers data, from the monotherapy dose escalation portion of the ongoing Phase 1/2 trial evaluating GV20-0251 in patients with advanced solid tumors resistant to anti-PD(L)1 and other standard therapies (NCT05669430).

Presentation details (Abstract CT001):

Title: Evaluation of pharmacodynamic and potential predictive biomarkers for GV20-0251, an anti-IGSF8 antibody, as monotherapy from ongoing Phase 1/2a study
Session Title: Updates in Anticancer Immunotherapies
Session Type: Oral Clinical Trial Minisymposium
Session Date/Time: Saturday April 18, 2026, 10:00 AM – 12:00 PM PDT

(Press release, GV20 Therapeutics, MAR 17, 2026, View Source [SID1234663638])

Synthekine Announces AACR 2026 Oral Presentation of Updated Phase 1a/1b Clinical and Translational Data for STK‑012 in First‑Line Nonsquamous NSCLC with Features of Immunotherapy Resistance

On March 17, 2026 Synthekine Inc., an engineered cytokine therapeutics company, reported that updated clinical and translational data from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, will be presented in an oral presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 taking place in San Diego, CA from April 17 – 22, 2026. In this now fully enrolled study, STK-012 is being evaluated in combination with standard-of-care pembrolizumab + chemotherapy in first-line nonsquamous (NSQ) non-small cell lung cancer (NSCLC) patients with features of immune resistance such as PD-L1 negative histology and STK11/KEAP1 mutations.

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"We are encouraged to share updated clinical and translational data from first‑line NSQ NSCLC patients treated with STK‑012, building on our prior oral presentation at SITC (Free SITC Whitepaper) 2025 and further supporting our novel and differentiated, α/β‑biased IL‑2 approach to precision immunotherapy," said Debanjan Ray, chief executive officer of Synthekine. "40% or more of newly diagnosed NSQ NSCLC patients have features of immune resistance, including PD‑L1‑negative histology or STK11/KEAP1 mutations, and typically derive limited benefit from standard‑of‑care chemoimmunotherapy. We believe STK‑012, in combination with pembrolizumab and chemotherapy, has the potential to meaningfully improve outcomes in this underserved patient population, and we look forward to presenting these updated data at AACR (Free AACR Whitepaper). Development of STK-012 is ongoing in our SYNERGY-101 study, a global, randomized Phase 2 trial which is currently enrolling patients."

Details are as follows and are available in the AACR (Free AACR Whitepaper) Online Program Planner:

Title: Selective immune activation of antigen activated T cells with STK-012, an a/b IL-2 receptor biased partial agonist, with pembrolizumab and chemotherapy in 1L PD-L1 negative non-squamous NSCLC
Session Title: Immunotherapy: Mechanisms and Responses
Session Date & Time: Tuesday, April 21, 2026, 2:30 – 4:30 PM PT
Location: Listed in the AACR (Free AACR Whitepaper) Online Program Planner
Abstract Number: 6740

A copy of the presentation will be available on Synthekine’s website following presentation at the meeting.

(Press release, Synthekine, MAR 17, 2026, View Source [SID1234663654])

SELLAS Life Sciences to Present Preclinical Data Highlighting Potent Activity of SLS009 in AML at the 2026 AACR Conference

On March 17, 2026 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that preclinical data on SLS009 (tambiciclib), a potent, selective CDK9 inhibitor, will be presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) taking place April 17-22 at San Diego Convention Center in San Diego, CA. The abstracts will be published in the online Proceedings of the AACR (Free AACR Whitepaper).

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Exposure of acute myeloid leukemia (AML) cell lines to increasing concentrations of SLS009 for 6 hours resulted in increased active caspase-3 levels and decreased MCL-1 expression. When cells were treated repeatedly for 8 hours up to 3 doses, the IC50 decreased from 50 nM to about 20 nM, demonstrating enhanced potency with repeated exposure. Changes in caspase-3 and MCL-1 were observed as early as 6 hours after completion of treatment and became more pronounced at 24 hours. Lower levels of MCL-1 and survivin were strongly correlated with increased apoptosis.

"These new data show tambiciclib’s promise in using optimized, clinically actionable schedules at patient-relevant concentrations," said Dr. Philip Amrein, clinician investigator at Mass General Brigham Cancer Institute and Assistant Professor of Medicine, Harvard Medical School, who designed and conducted experiments.

Notably, SLS009 demonstrated activity even in AML models harboring ASXL1 and TP53 mutations, which are typically associated with high resistance and poor clinical outcomes.

"These data demonstrate that SLS009 effectively targets AML cell survival mechanisms and induces apoptosis across diverse molecular subtypes, including high-risk genetic backgrounds," said Dr. Dragan Cicic, Senior Vice President and Chief Development Officer of SELLAS. "The ability to lower apoptotic threshold in AML cells by suppressing key survival pathways and enhancing potency with repeated exposure further supports the development of SLS009, including in combination regimens. We look forward to sharing the findings at this year’s AACR (Free AACR Whitepaper) conference."

Poster presentation details:

Title: Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels in AML cell lines

Session Title: Cell Death Pathways and Treatment

Session Date and Time: 4/21/2026 2:00:00 PM

Location: Poster Section 11

Abstract Presentation Number: 5666

(Press release, Sellas Life Sciences, MAR 17, 2026, View Source [SID1234663671])