Abeona Therapeutics® Reports First Quarter 2026 Results and Provides Pipeline Update
Rhea-AI Summary
Abeona Therapeutics (Nasdaq: ABEO) reported Q1 2026 net product revenue of $8.7 million, up from $2.4 million in Q4 2025, driven by ZEVASKYN.
Three patients were treated in Q1, the QTC network expanded to six sites, coverage policies now span 95% of commercially insured U.S. lives, and cash totaled $168.3 million.
Positive
- Net product revenue grew to $8.7M in Q1 2026 from $2.4M in Q4 2025
- ZEVASKYN cost of sales at $2.7M on three treated patients in Q1 2026
- Qualified treatment centers expanded to six with two new East Coast sites
- Coverage policies for ZEVASKYN now reach 95% of commercially insured U.S. lives
- Cash, cash equivalents and short-term investments of $168.3M as of March 31, 2026
- $7.4M reduction in underlying R&D expenses after excluding $7.0M PSMA-SIR-T upfront
Negative
- Net loss widened to $17.1M in Q1 2026 from $12.0M a year earlier
- Selling, general and administrative expenses rose $9.7M to $19.5M year-over-year
- Cash, cash equivalents and short-term investments fell from $191.4M to $168.3M in the quarter
- Single $7.0M upfront payment for ABO-701 in-licensing increased reported R&D spending
News Market Reaction – ABEO
In the May 13 session, ABEO gained 0.53%, reflecting a mild positive market reaction. Argus tracked a peak move of +8.4% during that session. Argus tracked a trough of -6.3% from its starting point during tracking. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 17 | Full-year 2025 results | Positive | -3.8% | Reported 2025 results, PRV sale gain, cash position, and early ZEVASKYN launch. |
| Nov 12 | Q3 2025 earnings | Positive | +18.5% | Q3 2025 update with cash runway, pending ZEVASKYN launch and HCPCS J-code. |
| Aug 14 | Q2 2025 earnings | Positive | +10.2% | Q2 2025 results featuring ZEVASKYN approval, strong cash and net income. |
| May 15 | Q1 2025 earnings | Positive | +7.4% | Q1 2025 results with ZEVASKYN FDA approval and PRV sale agreement. |
| Mar 20 | Full-year 2024 results | Positive | -1.1% | Full‑year 2024 results and pz-cel regulatory update ahead of PDUFA date. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings and major financial updates more often led to upside moves, but there are notable instances where seemingly positive updates coincided with selloffs.
Over the past year, Abeona’s earnings and financial updates have tracked the evolution of ZEVASKYN from late-stage regulatory review to commercial launch. Earlier releases highlighted FDA approval, first patient treatments, growing cash balances, and eventual commercialization with rising SG&A. Some reports triggered strong gains (e.g., Q3 and Q2 2025 updates), while others—like full‑year 2024 and full‑year 2025 results—saw modest declines despite operational progress. Today’s Q1 2026 report extends this commercialization narrative with higher product revenue and continued investment.
Key Terms
autologous medical
T-cell therapy medical
Prostate-Specific Membrane Antigen (PSMA) medical
Synthetic Immune Receptor (SIR-T™) medical
Investigational New Drug (IND) regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Three patients treated with ZEVASKYN® in Q1 2026 -
- QTC network expands to six sites, with two new additions on the East Coast -
- In-licensed radically novel engineered T-cell technology with game changing potential in the field of solid tumors; ophthalmology programs deprioritized -
-
- Webcast today at 8:30am ET -
CLEVELAND, May 13, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the first quarter of 2026, highlighting commercial momentum for ZEVASKYN.
- Steady increase in ZEVASKYN adoption with three patients completing treatment in the first quarter of 2026, one treatment to date in the second quarter, one biopsy currently in manufacturing process, and six additional patients expected to be biopsied in the second quarter, three of whom have biopsies scheduled.
- Qualified treatment center (QTC) network expands to six sites with the activation of New York-Presbyterian / Columbia University Irving Medical Center in New York, NY and Children’s Hospital of Philadelphia (CHOP).
- Patient access to ZEVASKYN continues to grow with published coverage policies now in place for
95% of commercially insured U.S. lives. - Data presentation at SID2026 on sustained wound healing and long-term safety after one-time pz-cel application: 12-year case report and 5-year Phase 3 data
“We are excited that an increasing number of patients at our QTCs are getting scheduled for ZEVASKYN slots this quarter,” said Vish Seshadri, PhD, President and CEO of Abeona Therapeutics. “We’re encouraged by the recent acceleration of onboarding efforts of QTCs to activate, so they can begin to treat patients with ZEVASKYN.”
Pipeline Update
Building on its proven end-to-end competency in engineered cell therapy, Abeona will focus its development efforts on ABO-701, a recently licensed radically novel engineered T-cell therapy targeting Prostate-Specific Membrane Antigen (PSMA). PSMA is a validated target for advanced prostate cancer, which is a leading cause of cancer mortality, with more than 30,000 deaths annually in the U.S. despite multiple approved therapies and recent advances in the field.
ABO-701 is an autologous engineered T-cell therapy 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 by Preet M. Chaudhary, M.D., Ph.D., Professor of Medicine and Chief of Jane Ann Nohl Division of Hematology and Center for the Study of Blood Diseases at University of Southern California (USC) Keck School of Medicine and Director of USC Blood and Marrow Transplant and Cell Therapy Program. The patents covering the SIR-T™ platform are owned by Angeles Therapeutics, Inc. In pre-clinical studies, ABO-701 has demonstrated durable tumor control in mouse models and modest levels of cytokine release – a profile that has been elusive to other engineered cell therapies in the solid tumors.
Abeona expects 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 the Company to maintain its focus on commercializing ZEVASKYN.
As part of the Company’s portfolio optimization, Abeona has deprioritized its in-house ophthalmology programs.
First Quarter 2026 Financial Results
Abeona reported net product revenue of
Cost of sales for the first quarter of 2026 was
Total research and development (R&D) expenses were
Selling, general and administrative (SG&A) expenses for the first quarter of 2026 were
Net loss was
Cash, cash equivalents and short-term investments totaled
Conference Call Details
The Company will host a conference call and webcast on Wednesday, May 13, 2026, at 8:30 a.m. ET to discuss its 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: 305519 five minutes prior to the start of the call. A live, listen-only webcast with slides can be accessed on the Investors & Media section of Abeona’s website at https://investors.abeonatherapeutics.com/events. An archived webcast replay will be available for 30 days following the call.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s ZEVASKYN® (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company’s fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The Company’s development portfolio features ABO-701 (PSMA-SIR-T™), a potentially first-in-class engineered T-cell therapy targeting PSMA, engineered to overcome the core failures of cell therapies in solid tumors. For more information, visit www.abeonatherapeutics.com.
ZEVASKYN®, Abeona Assist™, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc.
About Prostate Cancer
Prostate cancer is the most frequently diagnosed malignancy in men in the United States and remains a leading cause of cancer-related mortality. Most prostate cancer-related deaths are due to advanced disease, and high-grade localized disease almost inevitably progresses to advanced prostate cancer. Despite advances in androgen receptor pathway inhibitors, chemotherapy, and radioligand therapies, patients with advanced prostate cancer survive for a median of less than 2 years from starting therapy in the metastatic setting, underscoring the need for novel therapeutic strategies.
About Angeles Therapeutics
Angeles Therapeutics was founded by Preet M. Chaudhary, M.D., Ph.D. For inquiries regarding the SIR-T™ platform, please contact Angeles Therapeutics at info@angelestherapeutics.com or visit www.angelestherapeutics.com.
Forward-Looking Statements
This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “anticipate,” “expect,” “intend,” “potential,” and similar words and expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to, our ability to successfully commercialize and market ZEVASKYN, including manufacturing sufficient batches of ZEVASKYN to meet demand; the therapeutic potential of ZEVASKYN; whether the unmet need and market opportunity for ZEVASKYN are consistent with the Company’s expectations; continued interest in our portfolio; our ability to submit an investigational new drug application for ABO-701 and enroll patients in clinical trials; the outcome of future meetings with and inspections by the FDA or other regulatory agencies, including those relating to preclinical programs and to the cGMP manufacturing of ZEVASKYN; the ability to achieve or obtain necessary regulatory approvals for our pre-clinical programs; our ability to execute on our key business priorities; the impact of any changes in the financial markets and global economic conditions, including those resulting from changes to U.S. or other countries’ trade policy, such as current or future tariffs; risks associated with data analysis and reporting; and other risks disclosed in the Company’s most recent Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise these forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
Contacts:
Investor and Media
Abeona Therapeutics
ir@abeonatherapeutics.com
Investor
Lee M. Stern
Meru Advisors
lstern@meruadvisors.com
| Abeona Therapeutics Inc. and Subsidiaries Condensed Consolidated Statements of Operations and Comprehensive Loss ($ in thousands, except share and per share amounts) (Unaudited) | ||||||||
| For the three months ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ | 8,720 | $ | — | ||||
| Costs and expenses: | ||||||||
| Cost of sales | 2,696 | — | ||||||
| Research and development | 9,555 | 9,941 | ||||||
| Selling, general and administrative | 19,502 | 9,786 | ||||||
| Total costs and expenses | 31,753 | 19,727 | ||||||
| Loss from operations | (23,033 | ) | (19,727 | ) | ||||
| Interest income | 1,354 | 1,310 | ||||||
| Interest expense | (830 | ) | (998 | ) | ||||
| Change in fair value of warrant liabilities | 5,386 | 7,245 | ||||||
| Other income, net | 50 | 141 | ||||||
| Loss before income taxes | (17,073 | ) | (12,029 | ) | ||||
| Income tax expense | 2 | — | ||||||
| Net loss | $ | (17,075 | ) | $ | (12,029 | ) | ||
| Basic and dilutive loss per common share | $ | (0.30 | ) | $ | (0.24 | ) | ||
| Weighted average number of common shares outstanding - basic and diluted | 56,620,920 | 49,778,801 | ||||||
| Other comprehensive loss: | ||||||||
| Change in unrealized losses related to available-for-sale debt securities | (159 | ) | (75 | ) | ||||
| Comprehensive loss | $ | (17,234 | ) | $ | (12,104 | ) | ||
| Abeona Therapeutics Inc. and Subsidiaries Condensed Consolidated Balance Sheets ($ in thousands, except share and per share amounts) (Unaudited) | ||||||||
| March 31, 2026 | December 31, 2025 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 61,374 | $ | 78,437 | ||||
| Short-term investments | 106,897 | 112,967 | ||||||
| Accounts receivable, net | 6,200 | 6,147 | ||||||
| Inventory | 6,054 | 5,493 | ||||||
| Other receivables | 509 | 568 | ||||||
| Prepaid expenses and other current assets | 1,951 | 1,294 | ||||||
| Total current assets | 182,985 | 204,906 | ||||||
| Property and equipment, net | 10,564 | 9,921 | ||||||
| Operating lease right-of-use assets | 4,118 | 3,962 | ||||||
| Other assets | 827 | 781 | ||||||
| Total assets | $ | 198,494 | $ | 219,570 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,071 | $ | 7,889 | ||||
| Accrued expenses | 5,368 | 8,467 | ||||||
| Current portion of long-term debt | 13,333 | 12,222 | ||||||
| Current portion of operating lease liability | 1,272 | 864 | ||||||
| Payable to licensor | 7,000 | — | ||||||
| Accrued taxes and other current liabilities | 2 | 128 | ||||||
| Total current liabilities | 31,046 | 29,570 | ||||||
| Long-term operating lease liabilities | 3,814 | 4,069 | ||||||
| Long-term debt | 4,754 | 7,813 | ||||||
| Deferred revenue | 425 | — | ||||||
| Warrant liabilities | 13,516 | 18,902 | ||||||
| Total liabilities | 53,555 | 60,354 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock - | — | — | ||||||
| Common stock - | 568 | 550 | ||||||
| Additional paid-in capital | 903,542 | 900,603 | ||||||
| Accumulated deficit | (759,150 | ) | (742,075 | ) | ||||
| Accumulated other comprehensive (loss) income | (21 | ) | 138 | |||||
| Total stockholders' equity | 144,939 | 159,216 | ||||||
| Total liabilities and stockholders' equity | $ | 198,494 | $ | 219,570 | ||||
