ABEONA THERAPEUTICS INC.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
View on SEC.govAbout this filing
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.
Sep 30, 2026 · Filed Nov 9, 2026
ABEO$2.54-39.1%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001493152-26-050738
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 87 previous paragraphs and 90 current paragraphs.
46 unchanged; 29 reworded; 12 added; 5 removed; 7 previous and 3 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 (12)
Current report
Asset Acquisition
Current report
On November 9, 2026 (“the Closing Date”), we announced the acquisition of APT-1011, now ABO-801, from Ellodi Pharmaceuticals L.P. (“Ellodi”). ABO-801 is a Phase 3-ready, once-daily oral disintegrating tablet formulation of fluticasone propionate in development for eosinophilic esophagitis (EoE). Under the terms of the asset purchase agreement, we issued Ellodi $20 million in value of our common stock, par value $0.01 per share, which amounted to 4,494,383 shares (the “Upfront Shares”), based on the 20-trading-day volume weighted average price of the our common stock ending on the trading day immediately before the Closing Date. No upfront cash consideration is being paid to Ellodi. Ellodi is also eligible to receive payments of $30 million upon FDA approval of ABO-801 and up to an additional $30 million upon achievement of specified sales milestones. In addition, Ellodi is eligible to receive tiered royalties on net sales of ABO-801 ranging from low to mid teen percentages.
Current report
Private Placement
Current report
On November 6, 2026, we entered into a Securities Purchase Agreement (with a group of investors (the “Purchasers”) providing for the private placement (the “Private Placement”) to the Purchasers of (i) 6,400,000 shares of common stock, and (ii) pre-funded warrants to purchase 1,600,043 shares of common stock (the “Pre-Funded Warrants”), for an aggregate purchase price of approximately $30 million in gross proceeds before fees and expenses. Each Pre-Funded Warrant has an exercise price of $0.0001 per share of common stock. The closing of the Private Placement is expected to occur on November 10, 2026.
Current report
Research and development expenses for the three months ended September 30, 2026 were $3.7 million, as compared to $4.2 million for the same period of 2025, a decrease of $0.5 million. The reduction in expenses was primarily due to a reduction in costs associated with pre-clinical programs that were discontinued.
Current report
Selling, general and administrative expenses were $17.1 million for the three months ended September 30, 2026, as compared to $19.3 million for the same period of 2025, a decrease of $2.2 million. The decrease in expenses was primarily due to $2.1 million in costs associated with engineering runs that took place in the prior period.
Current report
The change in fair value of warrant liabilities was a non-cash gain of $6.5 million for the three months ended September 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 gain in the fair value of warrant liabilities was primarily due to the decrease in our stock price over the quarter and by a shorter term of the outstanding warrants.
Current report
The change in fair value of warrant liabilities was a non-cash gain of $2.8 million for the three months ended September 30, 2025. 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 report
Comparison of Nine months Ended September 30, 2026 and September 30, 2025
Current report
License and other revenues
Current report
Cost of sales during the nine months ended September 30, 2026 were $12.6 million and primarily includes costs associated with the commercial sale of ZEVASKYN including royalties due to our licensor, Stanford. Cost of sales during the nine months ended September 30, 2025 primarily includes costs associated with the August 2025 production of a full batch of ZEVASKYN®that could not be released due to technical issues that arose in implementing the rapid sterility lot release assay, mandated by the FDA during BLA review.
Current report
The change in fair value of warrant liabilities was a non-cash gain of $4.7 million for the nine months ended September 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 gain in the fair value of warrant liabilities was primarily due to the decrease in our stock price over the year and a shorter term of the outstanding warrants.
Removed paragraphs (5)
Previous 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.
Previous report
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 report
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 report
Comparison of Six Months Ended June 30, 2026 and June 30, 2025
Previous 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.
Reworded paragraphs (29)
Previous 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.
Current wording
On September 16, 2026, we announced activation of University of Florida Health as the newest qualified treatment center for the administration of ZEVASKYN. This represents the eighth 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 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.
Current wording
Product revenue, net, resulting from the sale of ZEVASKYN, for the three months ended September 30, 2026 was $13.5 million. There was no product revenue for the three months ended September 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 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.
Current wording
Cost of sales during the three months ended September 30, 2026 were $5.7 million and primarily includes costs associated with the commercial sale of ZEVASKYN including royalties due to our licensor, Stanford. Cost of sales during the three months ended September 30, 2025 primarily includes costs associated with the August 2025 production of a full batch of ZEVASKYN®that could not be released due to technical issues that arose in implementing the rapid sterility lot release assay, mandated by the FDA during BLA review.
Previous wording
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 wording
Interest income was $2.3 million for the three months ended September 30, 2026, as compared to $1.7 million in the same period of 2025. The increase resulting from timing of maturity and mix of our money market funds and short-term investment balances, offset by a decrease in the average money market funds and short-term investment balances period over period.
Previous 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.
Current wording
Interest expense was $0.6 million for the three months ended September 30, 2026 compared to $0.9 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
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 wording
Other (loss) income, net consisted of a loss of $2,000 for the three months ended September 30, 2026, as compared to income of $0.1 million 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.
Previous wording
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 wording
We recorded an income tax expense of $18,000 for the three months ended September 30, 2026. The amount relates to 2025 return to provision adjustments and included the impact of our generation of sufficient tax losses, after consideration of discrete items, to reduce our income tax expense for the period.
Previous wording
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.
Current wording
We recorded a current income tax benefit of $15.2 million for the three months ended September 30, 2025 related to 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 our taxable income and resulted in a current tax benefit for the three months ended September 30, 2025.
Previous wording
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 wording
Product revenue, net, resulting from the sale of ZEVASKYN, for the nine months ended September 30, 2026 was $33.6 million. There was no product revenue for the nine months ended September 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
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 wording
License and other revenues for the nine months ended September 30, 2026 were 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.
Previous wording
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 wording
Royalty expense for the nine months ended September 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.
Previous 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.
Current wording
Research and development expenses for the nine months ended September 30, 2026 were $18.2 million, as compared to $20.1 million for the same period of 2025, a decrease of $1.9 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 expenses decreased $8.9 million. The reduction in expenses was primarily due to costs capitalized into inventory, engineering runs and other production costs that are no longer considered research and development due to FDA approval of ZEVASKYN in April of 2025, and a reduction in costs associated with pre-clinical programs that were discontinued.
Previous 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.
Current wording
Selling, general and administrative expenses were $52.4 million for the nine months ended September 30, 2026, as compared to $46.2 million for the same period of 2025, an increase of $6.2 million. The increase in expenses was primarily due to increases in salaries and stock-based compensation of $6.5 million due to new hires.
Previous 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.
Current wording
Interest income was $5.0 million for the nine months ended September 30, 2026, as compared to $4.0 million in the same period of 2025. The increase resulted from increased average of our money market funds and short-term investment balances period over period.
Previous wording
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.
Current wording
Interest expense was $2.1 million for the nine months ended September 30, 2026 compared to $2.9 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 $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 wording
The change in fair value of warrant liabilities was a non-cash gain of $4.6 million for the nine months ended September 30, 2025. The gain in the fair value of warrant liabilities was primarily due to the decrease in our stock price as of September 30, 2025 compared to December 31, 2024 and to the shorter term period over period.
Previous wording
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 wording
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 nine months ended September 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.
Previous wording
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 wording
Other income, net consisted of $42,000 for the nine months ended September 30, 2026, as compared to $0.4 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.
Previous wording
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 wording
We recorded a current income tax expense of $0.3 million for the nine months ended September 30, 2025 which was driven by pre-tax income from the gain on sale of the PRV, offset by 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 our taxable income and resulting income tax expense for the nine months ended September 30, 2025.
Previous wording
Cash Flows for the Six Months Ended June 30, 2026 and 2025
Current wording
Cash Flows for the Nine Months Ended September 30, 2026 and 2025
Previous 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.
Current wording
Net cash used in operating activities was $45.6 million for the nine months ended September 30, 2026, primarily comprised of our net loss of $42.1 million, decreases in operating assets and liabilities of $11.2 million and net non-cash charges of $7.6 million. Non-cash charges consisted primarily of $4.7 million of gain as a result of the change in fair value of warrant liabilities, $9.1 million of stock-based compensation and $2.1 million of depreciation and amortization.
Previous 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.
Current wording
Net cash used in operating activities was $58.4 million for the nine months ended September 30, 2025, primarily comprised of our net income of $91.6 million, offset by a decrease in operating assets and liabilities of $4.8 million and net non-cash charges of $145.2 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, $4.6 million of gain as a result of the change in fair value of warrant and derivative liabilities, $8.2 million of stock-based compensation and $1.7 million of depreciation and amortization.
Previous 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.
Current wording
Net cash provided by investing activities was $42.4 million for the nine months ended September 30, 2026, primarily comprised of proceeds from maturities of short-term investments of $115.8 million, offset by purchases of short-term investments of $71.8 million and capital expenditures of $1.6 million.
Previous 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.
Current wording
Net cash provided by investing activities was $95.5 million for the nine months ended September 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 $118.8 million, offset by purchases of short-term investments of $168.9 million and capital expenditures of $6.8 million.
Previous 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.
Current wording
Net cash used in financing activities was $8.9 million for the nine months ended September 30, 2026, comprised of $8.9 million in payments on our long-term debt.
Previous 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).
Current wording
Net cash provided by financing activities was $22.4 million for the nine months ended September 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) and proceeds of $5.2 million from the exercise of stock purchase warrants.
Previous 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.
Current wording
Our principal source of liquidity is cash, cash equivalents and short-term investments, collectively referred to as our cash resources. As of September 30, 2026, our cash resources were $134.9 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 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.
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 nine months ended September 30, 2025. There were no sales of our common stock under the ATM agreement during the nine months ended September 30, 2026. Under the ATM Agreement and as of September 30, 2026, we have remaining shares of our common stock for an aggregate sales price of up to $51.5 million.
Previous wording
If we raise additional funds by selling additional equity securities, the relative equity ownership of our existing investors will be diluted, and the new investors could obtain terms more favorable than previous investors. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financing when needed, we may be required to delay, limit, or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates to third parties that we would otherwise prefer to develop and market ourselves.
Current wording
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, including potential collaborations, strategic alliances, licensing arrangements, asset dispositions with third parties and other similar arrangements. If we raise additional funds by selling additional equity securities, the relative equity ownership of our existing investors will be diluted, and the new investors could obtain terms more favorable than previous investors. If we raise additional funds through collaborations, strategic alliances, licensing arrangements, or asset dispositions with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financing when needed, we may be required to delay, limit, or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates to third parties that we would otherwise prefer to develop and market ourselves.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
On July 21, 2026, we announced activation of Cincinnati Children’s Hospital Medical Center as a qualified treatment center for the administration of ZEVASKYN.
Current report — wording carried from elsewhere
Change in fair value of warrant liabilities
Current report — wording carried from elsewhere
We recorded an income tax expense of $20,000 for the nine months ended September 30, 2026. The amount relates to 2025 return to provision adjustments and included the impact of our generation of sufficient tax losses, after consideration of discrete items, to reduce our income tax expense for the period.
Rearranged previous paragraphs (7)
Previous report — wording carried 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.
Previous report — wording carried elsewhere
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 report — wording carried elsewhere
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.
Previous report — wording carried 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.
Previous report — wording carried elsewhere
Change in fair value of warrant and derivative liabilities
Previous report — wording carried elsewhere
Gain from sale of priority review voucher, net
Previous report — wording carried elsewhere
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.