ABEONA THERAPEUTICS INC.
For the period ended Jun 30, 2026. Filed Aug 13, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 13, 2026
ABEO$4.17+6.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-13.
0001493152-26-022614
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001493152-26-037576
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 64 previous paragraphs and 87 current paragraphs.
34 unchanged; 21 reworded; 27 added; 9 removed; 0 previous and 5 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (27)
Current report
We are 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”). Our fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. Our 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.
Current report
License and other revenues for the three months ended June 30, 2026 was nil as compared to $0.4 million for the same period of 2025. The revenue in 2025 of $0.4 million consists of revenue resulting from a third party exercising its option to license certain of our AAV capsids.
Current report
Total selling, general and administrative expenses were $15.8 million for the three months ended June 30, 2026, as compared to $17.1 million for the same period of 2025, a decrease of $1.3 million. The decrease in expenses was primarily due to $0.9 million of costs that were allocated to costs of sales related to overhead costs and a reduction in recruiting costs of $0.4 million as we had fewer increases in new employees.
Current report
Gain from sale of priority review voucher, net
Current report
In May 2025, we sold our PRV awarded to us following the FDA approval of ZEVASKYN™. We received gross proceeds of $155.0 million during the three months ended June 30, 2025 and recognized a gain from the PRV sale of $152.4 million, net of transaction costs of $2.6 million, as it did not have a carrying value at the time of sale.
Current report
Other (loss) income, net
Current report
Other (loss) income, net consisted of a loss of $6,000 for the three months ended June 30, 2026, as compared to income of $89,000 in the same period of 2025. The decrease was primarily a result of not having sublease income in 2026. The sublease of our New York office ended in September of 2025.
Current report
We recorded a current income tax expense of $15.5 million for the three months ended June 30, 2025. The current income tax expense for the three months ended June 30, 2025 was driven by pre-tax income from the gain on sale of priority review voucher, resulting in $14.6 million of federal income tax expense and $0.9 million of state income tax expense. This was subsequently reduced in the third quarter of 2025 as a result of the favorable impact of the One Big Beautiful Bill Act, enacted on July 4, 2025. The legislation restored immediate expensing of domestic R&D expenditures, reinstated 100% bonus depreciation, and provided more favorable rules for determining the limitation on business interest expense, which collectively reduced the Company’s taxable income and resulting income tax expense for the year ended December 31, 2025.
Current report
Comparison of Six Months Ended June 30, 2026 and June 30, 2025
Current report
Product revenue, net
Current report
License and other revenues for the six months ended June 30, 2026 was nil as compared to $0.4 million for the same period of 2025. The revenue in 2025 of $0.4 million consists of revenue resulting from a third party exercising its option to license certain of our AAV capsids.
Current report
Cost of sales
Current report
Royalties
Current report
Total royalty expense for the six months ended June 30, 2026 was nil as compared to $0.1 million for the same period of 2025. Royalties in 2025 consisted of amounts owed to the University of North Carolina at Chapel Hill resulting from the milestones due from the exercise of an option by a third party to license certain of our AAV capsids.
Current report
Research and development
Current report
Selling, general and administrative
Current report
Interest income
Current report
Interest expense
Current report
Change in fair value of warrant and derivative liabilities
Current report
The change in fair value of warrant liabilities was a loss of $1.8 million for the six months ended June 30, 2026. We issued stock purchase warrants that are required to be classified as a liability and valued at fair market value at each reporting period. The loss in the fair value of warrant liabilities was primarily due to the increase in our stock price over the year offset by a shorter term of the outstanding warrants.
Current report
The change in fair value of warrant liabilities was a gain of $1.9 million for the six months ended June 30, 2025. We issued stock purchase warrants that are required to be classified as a liability and valued at fair market value at each reporting period. The gain in the fair value of warrant liabilities was primarily due to the shorter term period over period.
Current report
Gain from sale of priority review voucher, net
Current report
In May 2025, we sold our PRV awarded to us following the FDA approval of ZEVASKYN™. We received gross proceeds of $155.0 million during the six months ended June 30, 2025 and recognized a gain from the PRV sale of $152.4 million, net of transaction costs of $2.6 million, as it did not have a carrying value at the time of sale.
Current report
Other income, net consisted of $44,000 for the six months ended June 30, 2026, as compared to $0.2 million in the same period of 2025. The decrease was primarily a result of not having sublease income in 2026. The sublease of our NY office ended in September of 2025.
Current report
Income tax expense
Current report
We recorded a current income tax expense of $2,000 for the six months ended June 30, 2026 which included the impact of our generation of sufficient tax losses, after consideration of discrete items, to reduce our income tax expense for the period.
Current report
We recorded a current income tax expense of $15.5 million for the six months ended June 30, 2025. The current income tax expense for the six months ended June 30, 2025 was driven by pre-tax income from the gain on sale of priority review voucher, resulting in $14.6 million of federal income tax expense and $0.9 million of state income tax expense. This was subsequently reduced in the third quarter of 2025 as a result of the favorable impact of the One Big Beautiful Bill Act, enacted on July 4, 2025. The legislation restored immediate expensing of domestic R&D expenditures, reinstated 100% bonus depreciation, and provided more favorable rules for determining the limitation on business interest expense, which collectively reduced the Company’s taxable income and resulting income tax expense for the year ended December 31, 2025.
Removed paragraphs (9)
Previous report
We are a commercial-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. On April 28, 2025, the FDA approved ZEVASKYN® (prademagene zamikeracel) gene-modified cellular sheets, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB, a serious and debilitating genetic skin disease. There is no cure for RDEB, and ZEVASKYN® is the only FDA-approved product to treat RDEB wounds with a single application. ZEVASKYN® was granted Orphan Drug and Rare Pediatric Disease designations by the FDA.
Previous report
ZEVASKYN® is manufactured at our cGMP manufacturing facility in Cleveland, Ohio, and is made available through ZEVASKYN® qualified treatment centers.
Previous report
On April 2, 2026, we announced activation of NewYork-Presbyterian/Columbia University Irving Medical Center in New York City as another qualified treatment center for the administration of ZEVASKYN®.
Previous report
Pipeline Update
Previous report
Building on our proven end-to-end competency in engineered cell therapy, we will focus our development efforts on the development of ABO-701, a recently licensed radically novel engineered T-cell therapy, targeting Prostate-Specific Membrane Antigen (“PSMA”) to treat prostate cancer. 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.
Previous report
ABO-701 is an autologous engineered T-cell product 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 in the laboratory of 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.
Previous report
We expect 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 us to maintain our focus on commercializing ZEVASKYN®.
Previous report
As part of our portfolio optimization, we have deprioritized our in-house ophthalmology programs.
Previous report
Other income, net was $50,000 for the three months ended March 31, 2026, as compared to $141,000 in the same period of 2025. The decrease was primarily a result of realized losses on foreign currency related to various vendors that we pay in foreign currency during the three months ended March 31, 2026.
Reworded paragraphs (21)
Previous wording
On May 11, 2026, we announced activation of Children’s Hospital of Philadelphia as the newest qualified treatment center for the administration of ZEVASKYN®. This represents the sixth available qualified treatment center for the administration of ZEVASKYN®.
Current wording
On July 21, 2026, we announced activation of Cincinnati Children’s as the newest qualified treatment center for the administration of ZEVASKYN. This represents the seventh available qualified treatment center for the administration of ZEVASKYN.
Previous wording
Product revenue, net, resulting from the sale of ZEVASKYN®, for the three months ended March 31, 2026 was $8.7 million. There was no product revenue for the three months ended March 31, 2025 as the approval by the FDA for ZEVASKYN® did not occur until April of 2025.
Current wording
Product revenue, net, resulting from the sale of ZEVASKYN, for the three months ended June 30, 2026 was $11.4 million. There was no product revenue for the three months ended June 30, 2025 as the approval by the FDA for ZEVASKYN occurred in April of 2025 and we recorded our first sale in December of 2025.
Previous wording
Cost of sales during the three months ended March 31, 2026 was $2.7 million and primarily includes costs associated with the commercial sale of ZEVASKYN® including royalties due to our licensor, Stanford. There was no cost of sales in the same period of 2025, as ZEVASKYN®was approved by the FDA in April 2025.
Current wording
Cost of sales during the three months ended June 30, 2026 was $4.2 million and primarily includes costs associated with the commercial sale of ZEVASKYN including royalties due to our licensor, Stanford. There was no cost of sales in the same period of 2025, as ZEVASKYN was approved by the FDA in April 2025 and we recorded our first sale in December of 2025.
Previous wording
We expect our research and development activities to increase as we work towards advancing other product candidates towards potential regulatory approval, reflecting costs associated with the following:
Current wording
We expect our research and development activities to increase as we work towards advancing our other product candidate towards potential regulatory approval, reflecting costs associated with the following:
Previous wording
Selling, general and administrative expenses primarily consist of payroll and personnel costs, office facility costs, public company reporting related costs, professional fees (e.g., legal expenses), selling and commercialization costs and other general operating expenses not otherwise included in research and development expenses. We expect our selling, general, and administrative costs to continue to increase as we expand our commercialization of ZEVASKYN®and pursue development of other product candidates.
Current wording
Selling, general and administrative expenses primarily consist of payroll and personnel costs, office facility costs, public company reporting related costs, professional fees (e.g., legal expenses), selling and commercialization costs and other general operating expenses not otherwise included in research and development expenses. We expect our selling, general, and administrative costs to continue to increase as we expand our commercialization of ZEVASKYN.
Previous wording
Interest income was $1.4 million for the three months ended March 31, 2026, as compared to $1.3 million in the same period of 2025. The increase resulted from higher earnings on short-term investments driven by increased average short-term investment balances.
Current wording
Interest income was $1.4 million for the three months ended June 30, 2026, as compared to $1.0 million in the same period of 2025. The increase resulted from increased average short-term investment balances.
Previous wording
Interest expense was $0.8 million for the three months ended March 31, 2026 compared to $1.0 million in the same period of 2025. Interest expense was due to the credit facility entered into by the Company in January 2024 and decreased as a result of the July 2025 Loan Agreement Amendment plus a reduction of the principal loan amount due to payments made in 2026.
Current wording
Interest expense was $0.7 million for the three months ended June 30, 2026 compared to $1.0 million in the same period of 2025. Interest expense was due to the credit facility entered into by the Company in January 2024 and decreased as a result of the July 2025 Loan Agreement Amendment plus a reduction of the principal loan amount due to principal payments made in 2026.
Previous wording
The change in fair value of warrant liabilities was a gain of $5.4 million for the three months ended March 31, 2026. We issued stock purchase warrants that are required to be classified as a liability and valued at fair market value at each reporting period. The gain in the fair value of warrant liabilities was primarily due to the decrease in our stock price over the quarter and a shorter term of the outstanding warrants.
Current wording
The change in fair value of warrant liabilities was a loss of $7.2 million for the three months ended June 30, 2026. We issued stock purchase warrants that are required to be classified as a liability and valued at fair market value at each reporting period. The loss in the fair value of warrant liabilities was primarily due to the increase in our stock price over the quarter offset by a shorter term of the outstanding warrants.
Previous wording
The change in fair value of warrant liabilities was a gain of $7.2 million for the three months ended March 31, 2025. The gain in the fair value of warrant liabilities was primarily due to the decrease in our stock price year over the year and a shorter term.
Current wording
The change in fair value of warrant liabilities was a loss of $5.4 million for the three months ended June 30, 2025. The loss in the fair value of warrant liabilities was primarily due to the increase in our stock price year over year offset by a shorter term of the outstanding warrants.
Previous wording
We recorded a current income tax expense of $2,000 for the three months ended March 31, 2026. We did not record an income tax expense for the three months ended March 31, 2025 as we generated sufficient tax losses, after consideration of discrete items.
Current wording
We did not record an income tax expense for the three months ended June 30, 2026 as we generated sufficient tax losses, after consideration of discrete items.
Previous wording
Total research and development spending for the three months ended March 31, 2026 was $9.6 million, as compared to $9.9 million for the same period of 2025, a decrease of $0.3 million. In March 2026, we entered a license and joint development agreement related to PSMA SIR-T™ which included an upfront payment of $7.0 million that was included in research and development expenses. Excluding this transaction, research and development spending decreased $7.4 million. The reduction in expenses was primarily due to costs capitalized into inventory and engineering runs and other production costs that are no longer considered research and development due to FDA approval of ZEVASKYN®in April of 2025.
Current wording
Total research and development spending for the six months ended June 30, 2026 was $14.6 million, as compared to $15.9 million for the same period of 2025, a decrease of $1.3 million. In March 2026, we entered a license and joint development agreement related to PSMA SIR-T™ which included an upfront payment of $7.0 million that was included in research and development expenses. Excluding this transaction, research and development spending decreased $8.3 million. The reduction in expenses was primarily due to costs capitalized into inventory and, engineering runs and other production costs that are no longer considered research and development due to FDA approval of ZEVASKYN in April of 2025.
Previous wording
Total selling, general and administrative expenses were $19.5 million for the three months ended March 31, 2026, as compared to $9.8 million for the same period of 2025, an increase of $9.7 million. The increase in expenses was primarily due to increases in salaries and stock-based compensation of $5.4 million due to new hires, $1.9 million of costs related to engineering runs with the remainder due to other commercial costs related to our continued commercialization efforts upon FDA approval in April of 2025.
Current wording
Total selling, general and administrative expenses were $35.3 million for the six months ended June 30, 2026, as compared to $26.9 million for the same period of 2025, an increase of $8.4 million. The increase in expenses was primarily due to increases in salaries and stock-based compensation of $5.7 million due to new hires, $1.9 million of costs related to engineering runs with the remainder due to other commercial costs related to our continued commercialization efforts upon FDA approval in April of 2025.
Previous wording
Cash Flows for the Three Months Ended March 31, 2026 and 2025
Current wording
Cash Flows for the Six Months Ended June 30, 2026 and 2025
Previous wording
Net cash used in operating activities was $19.8 million for the three months ended March 31, 2026, primarily comprised of our net loss of $17.1 million and decreases in operating assets and liabilities of $1.4 million and net non-cash charges of $1.3 million. Non-cash charges consisted primarily of $5.4 million of gain as a result of the change in fair value of warrant liabilities, $3.0 million of stock-based compensation and $0.7 million of depreciation and amortization.
Current wording
Net cash used in operating activities was $37.3 million for the six months ended June 30, 2026, primarily comprised of our net loss of $37.3 million, decreases in operating assets and liabilities of $10.5 million and net non-cash charges of $10.4 million. Non-cash charges consisted primarily of $1.8 million of loss as a result of the change in fair value of warrant liabilities, $6.3 million of stock-based compensation and $1.4 million of depreciation and amortization.
Previous wording
Net cash used in operating activities was $18.4 million for the three months ended March 31, 2025, primarily comprised of our net loss of $12.0 million and decreases in operating assets and liabilities of $3.4 million and net non-cash charges of $3.0 million. Non-cash charges consisted primarily of $7.2 million of gain as a result of the change in fair value of warrant liabilities, $2.7 million of stock-based compensation and $0.5 million of depreciation and amortization.
Current wording
Net cash used in operating activities was $37.2 million for the six months ended June 30, 2025, primarily comprised of our net income of $96.8 million and increases in operating assets and liabilities of $12.4 million offset by net non-cash charges of $146.2 million. Non-cash charges consisted primarily of $152.4 million gain on sale of priority review voucher for which the cash proceeds are recorded in investing activities, $1.9 million of gain as a result of the change in fair value of warrant and derivative liabilities, $5.5 million of stock-based compensation and $1.1 million of depreciation and amortization.
Previous wording
Net cash provided by investing activities was $4.2 million for the three months ended March 31, 2025, primarily comprised of proceeds from maturities of short-term investments of $54.2 million, offset by purchases of short-term investments of $48.6 million and capital expenditures of $1.4 million.
Current wording
Net cash provided by investing activities was $20.6 million for the six months ended June 30, 2026, primarily comprised of proceeds from maturities of short-term investments of $65.8 million, offset by purchases of short-term investments of $43.7 million and capital expenditures of $1.4 million.
Previous wording
Net cash provided by investing activities was $5.0 million for the three months ended March 31, 2026, primarily comprised of proceeds from maturities of short-term investments of $24.9 million, offset by purchases of short-term investments of $19.0 million and capital expenditures of $0.9 million.
Current wording
Net cash provided by investing activities was $160.1 million for the six months ended June 30, 2025, primarily comprised of net proceeds from sale of priority review voucher of $152.4 million, proceeds from maturities of short-term investments of $80.5 million, offset by purchases of short-term investments of $68.5 million and capital expenditures of $4.3 million.
Previous wording
Net cash used in financing activities was $2.2 million for the three months ended March 31, 2026, comprised of $2.2 million in payments on our long-term debt.
Current wording
Net cash used in financing activities was $5.6 million for the six months ended June 30, 2026, comprised of $5.6 million in payments on our long-term debt.
Previous wording
Net cash provided by financing activities was $6.8 million for the three months ended March 31, 2025, primarily comprised of proceeds of $6.8 million from open market sales of common stock pursuant to the ATM Agreement (as defined below).
Current wording
Net cash provided by financing activities was $17.3 million for the six months ended June 30, 2025, primarily comprised of proceeds of $17.3 million from open market sales of common stock pursuant to the ATM Agreement (as defined below).
Previous wording
Our principal source of liquidity is cash, cash equivalents, restricted cash and short-term investments, collectively referred to as our cash resources. As of March 31, 2026, our cash resources were $168.3 million. We believe that our current cash and cash equivalents, restricted cash and short-term investments are sufficient to fund operations through at least the next 12 months from the date of this report on Form 10-Q. We may need to secure additional funding to carry out all of our planned research and development and potential commercialization activities. If we are unable to obtain additional financing or generate license or product revenue, the lack of liquidity and sufficient capital resources could have a material adverse effect on our future prospects.
Current wording
Our principal source of liquidity is cash, cash equivalents and short-term investments, collectively referred to as our cash resources. As of June 30, 2026, our cash resources were $146.8 million. We believe that our current cash and cash equivalents and short-term investments are sufficient to fund operations through at least the next 12 months from the date of this report on Form 10-Q. We may need to secure additional funding to carry out all of our planned research and development and potential commercialization activities. If we are unable to obtain additional financing or generate license or product revenue, the lack of liquidity and sufficient capital resources could have a material adverse effect on our future prospects.
Previous wording
We have an open market sale agreement with Jefferies LLC (as amended, the “ATM Agreement”) pursuant to which, we may sell from time to time, through Jefferies LLC, shares of our common stock for an aggregate sales price of up to $75.0 million. Any sales of shares pursuant to this agreement are made under our effective “shelf” registration statement on Form S-3 that is on file with and has been declared effective by the SEC. We sold 1,312,283 shares of our common stock under the ATM Agreement and received $6.8 million of net proceeds during the three months ended March 31, 2025. There were no sales of our common stock under the ATM agreement during the three months ended March 31, 2026. Under the ATM Agreement and as of March 31, 2026, we have remaining shares of our common stock for an aggregate sales price of up to $51.5 million.
Current wording
We have an open market sale agreement with Jefferies LLC (as amended, the “ATM Agreement”) pursuant to which, we may sell from time to time, through Jefferies LLC, shares of our common stock for an aggregate sales price of up to $75.0 million. Any sales of shares pursuant to this agreement are made under our effective “shelf” registration statement on Form S-3 that is on file with and has been declared effective by the SEC. We sold 3,510,889 shares of our common stock under the ATM Agreement and received $17.3 million of net proceeds during the six months ended June 30, 2025. There were no sales of our common stock under the ATM agreement during the six months ended June 30, 2026. Under the ATM Agreement and as of June 30, 2026, we have remaining shares of our common stock for an aggregate sales price of up to $51.5 million.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
Total research and development spending for the three months ended June 30, 2026 was $5.0 million, as compared to $5.9 million for the same period of 2025, a decrease of $0.9 million. The reduction in expenses was primarily due to costs capitalized into inventory and other production costs that are no longer considered research and development due to FDA approval of ZEVASKYN in April of 2025.
Current report — wording carried from elsewhere
Product revenue, net, resulting from the sale of ZEVASKYN, for the six months ended June 30, 2026 was $20.1 million. There was no product revenue for the six months ended June 30, 2025 as the approval by the FDA for ZEVASKYN occurred in April of 2025 and we recorded our first sale in December of 2025.
Current report — wording carried from elsewhere
Cost of sales during the six months ended June 30, 2026 was $6.9 million and primarily includes costs associated with the commercial sale of ZEVASKYN including royalties due to our licensor, Stanford. There was no cost of sales in the same period of 2025, as ZEVASKYN was approved by the FDA in April 2025 and we recorded our first sale in December of 2025.
Current report — wording carried from elsewhere
Interest income was $2.7 million for the six months ended June 30, 2026, as compared to $2.3 million in the same period of 2025. The increase resulted from increased average short-term investment balances.
Current report — wording carried from elsewhere
Interest expense was $1.5 million for the six months ended June 30, 2026 compared to $2.0 million in the same period of 2025. Interest expense was due to the credit facility entered into by the Company in January 2024 and decreased as a result of the July 2025 Loan Agreement Amendment plus a reduction of the principal loan amount due to principal payments made in 2026.