- Three patients treated with ZEVASKYN® in Q1 2026 -
- QTC network expands to six sites, with two new additions on the
- In-licensed radically novel engineered T-cell technology with game changing potential in the field of solid tumors; ophthalmology programs deprioritized -
-
- Webcast today at
- 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 inNew York, NY and Children’s Hospital ofPhiladelphia (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
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
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
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
About
ZEVASKYN®, Abeona Assist™,
About Prostate Cancer
Prostate cancer is the most frequently diagnosed malignancy in men in
About Angeles Therapeutics
Angeles Therapeutics was founded by
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
Contacts:
Investor and Media
ir@abeonatherapeutics.com
Investor
lstern@meruadvisors.com
Condensed Consolidated Statements of Operations and Comprehensive Loss ($ in thousands, except share and per share amounts) (Unaudited) | ||||||||
| For the three months ended | ||||||||
| 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 | ) | ||
Condensed Consolidated Balance Sheets ($ in thousands, except share and per share amounts) (Unaudited) | ||||||||
| 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 | ||||
