Full Press Release Details
- First anticipated ZEVASKYN®patient treatment shifted to 4Q 2025 following implementation of optimized release assay -
- Strong and growing patient demand and treatment site network, along with broad market access provide foundation for sustainable commercial success -
- $207.5M in cash, cash equivalents, restricted cash and short-term investments as of September 30, 2025 expected to fund operations for over two years -
CLEVELAND, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results and business highlights for the third quarter of 2025 and shared recent operational progress.
“We are scaling the ZEVASKYN launch to meet patient needs,” said Vish Seshadri, Chief Executive Officer of Abeona. “We have strong and growing patient demand. Despite a one-quarter shift in patient starts, we remain steadfast in our 2026 launch goals. Our conviction is built on our expanding treatment site network and powerful momentum from the patient and caregiver community.”
Recent Developments
ZEVASKYN (prademagene zamikeracel)
Other corporate updates
Financial Results
Cash, cash equivalents, restricted cash and short-term investments totaled $207.5 million as of September 30, 2025. The current cash position, without accounting for anticipated revenue from ZEVASKYN, is expected to be sufficient to fund current and planned operations for over two years.
Research and development (R&D) spending for the three months ended September 30, 2025 was $4.2 million, compared to $8.9 million for the same period of 2024. The reduction in R&D expense was primarily due to costs capitalized into inventory and select costs, such as engineering runs and other production costs, reclassified as selling, general, and administrative (SG&A) following FDA approval of ZEVASKYN. SG&A expenses were $19.3 million for the three months ended September 30, 2025, compared to $6.4 million for the same period of 2024. In addition to the reclassification of select R&D expenses to SG&A, the increase in SG&A reflects increased headcount and professional costs associated with the commercial launch of ZEVASKYN.
Net loss was $(5.2) million for the third quarter of 2025, or $(0.10) per basic and diluted common share. Net loss in the third quarter of 2024 was $(30.3) million, or $(0.63) per basic and diluted common share.
Conference Call Details
The Company will host a conference call and webcast on Wednesday, November 12, 2025, at 8:30 a.m. ET, to discuss the financial results and corporate progress. To access the call, dial 877-545-0523 (U.S. toll-free) or 973-528-0016 (international) and Entry Code: 922481 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 athttps://investors.abeonatherapeutics.com/events. The archived webcast replay will be available for 30 days following the call.
About Abeona TherapeuticsAbeona 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 adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated for a variety of devastating diseases. For more information, visitwww.abeonatherapeutics.com.
ZEVASKYN®, Abeona Assist™, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc.
Forward-Looking StatementsThis 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 rare disease portfolio; our ability to 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; the impact of any changes in the financial markets and global economic conditions, including those resulting from changes to U.S. 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.
| ABEONA THERAPEUTICS INC. AND SUBSIDIARIESCondensed Consolidated Statements of Operations and Comprehensive Income(In thousands, except share and per share amounts)(Unaudited) | |||||||||||||||
| For the three months endedSeptember 30, | For the nine months endedSeptember 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenues: | |||||||||||||||
| License and other revenues | $ | — | $ | — | $ | 400 | $ | — | |||||||
| Costs and expenses: | |||||||||||||||
| Cost of sales | $ | 488 | $ | — | $ | 488 | $ | — | |||||||
| Royalties | — | — | 100 | — | |||||||||||
| Research and development | 4,216 | 8,941 | 20,100 | 25,366 | |||||||||||
| Selling, general and administrative | 19,314 | 6,404 | 46,249 | 22,173 | |||||||||||
| Total costs and expenses | 24,018 | 15,345 | 66,937 | 47,539 | |||||||||||
| Loss from operations | (24,018 | ) | (15,345 | ) | (66,537 | ) | (47,539 | ) | |||||||
| Interest income | 1,672 | 1,189 | 4,009 | 3,223 | |||||||||||
| Interest expense | (901 | ) | (1,102 | ) | (2,856 | ) | (3,126 | ) | |||||||
| Change in fair value of warrant and derivative liabilities | 2,760 | (15,156 | ) | 4,617 | (7,530 | ) | |||||||||
| Gain from sale of priority review voucher, net | — | — | 152,366 | — | |||||||||||
| Other income | 129 | 145 | 359 | 531 | |||||||||||
| Income (loss) before income taxes | (20,358 | ) | (30,269 | ) | 91,958 | (54,441 | ) | ||||||||
| Income tax (benefit) expense | (15,197 | ) | — | 315 | — | ||||||||||
| Net income (loss) | $ | (5,161 | ) | $ | (30,269 | ) | $ | 91,643 | $ | (54,441 | ) | ||||
| Basic income (loss) per common share | $ | (0.10 | ) | $ | (0.63 | ) | $ | 1.76 | $ | (1.41 | ) | ||||
| Dilutive income (loss) per common share | $ | (0.10 | ) | $ | (0.63 | ) | $ | 1.35 | $ | (1.41 | ) | ||||
| Weighted average number of common shares outstanding: | |||||||||||||||
| Basic | 54,242,507 | 48,081,758 | 52,198,290 | 38,504,273 | |||||||||||
| Dilutive | 54,242,507 | 48,081,758 | 65,780,650 | 38,504,273 | |||||||||||
| Other comprehensive income (loss): | |||||||||||||||
| Change in unrealized gains related to available-for-sale debt securities | 55 | 50 | 2 | (18 | ) | ||||||||||
| Comprehensive income (loss) | $ | (5,106 | ) | $ | (30,219 | ) | $ | 91,645 | $ | (54,459 | ) | ||||
| ABEONA THERAPEUTICS INC. AND SUBSIDIARIESCondensed Consolidated Balance Sheets(In thousands, except share and per share amounts)(Unaudited) | |||||||
| September 30,2025 | December 31,2024 | ||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 82,884 | $ | 23,357 | |||
| Short-term investments | 124,233 | 74,363 | |||||
| Restricted cash | 338 | 338 | |||||
| Inventory | 4,850 | — | |||||
| Other receivables | 1,616 | 1,652 | |||||
| Prepaid expenses and other current assets | 2,209 | 1,143 | |||||
| Total current assets | 216,130 | 100,853 | |||||
| Property and equipment, net | 10,338 | 4,430 | |||||
| Operating lease right-of-use assets | 4,086 | 3,552 | |||||
| Other assets | 541 | 96 | |||||
| Total assets | $ | 231,095 | $ | 108,931 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 5,927 | $ | 3,441 | |||
| Accrued expenses | 6,888 | 6,333 | |||||
| Current portion of long-term debt | 8,889 | 5,926 | |||||
| Current portion of operating lease liability | 102 | 823 | |||||
| Accrued taxes | 339 | — | |||||
| Other current liabilities | 35 | 64 | |||||
| Total current liabilities | 22,180 | 16,587 | |||||
| Long-term operating lease liabilities | 4,254 | 3,262 | |||||
| Long-term debt | 10,862 | 13,037 | |||||
| Warrant liabilities | 22,566 | 32,014 | |||||
| Total liabilities | 59,862 | 64,900 | |||||
| Commitments and contingencies | |||||||
| Stockholders' equity: | |||||||
| Preferred stock - $0.01 par value; authorized 2,000,000 shares; No shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | — | — | |||||
| Common stock - $0.01 par value; authorized 200,000,000 shares; 52,400,415 and 45,644,091 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | 524 | 457 | |||||
| Additional paid-in capital | 892,314 | 856,824 | |||||
| Accumulated deficit | (721,615 | ) | (813,258 | ) | |||
| Accumulated other comprehensive income | 10 | 8 | |||||
| Total stockholders' equity | 171,233 | 44,031 | |||||
| Total liabilities and stockholders' equity | $ | 231,095 | $ | 108,931 | |||