Liquidity	3 Months Ended
Dec. 31, 2025
Liquidity
Liquidity	2. Liquidity The Company has incurred recurring losses and negative cash flows from operations since its inception and has an accumulated deficit of $628,767,898 as of December 31, 2025. As of December 31, 2025, the Company had a working capital deficit. Additionally, the Company has $32,234,985 of principal, accrued interest and exit fees due under an unsecured convertible promissory note issued to Avondale Capital, LLC (“Avondale”) in March 2025 (the “March 2025 Note”), maturing on July 1, 2026. Refer to Note 7 for further details on the March 2025 Note. On December 31, 2025, the Company did not satisfy the required $3,000,000 Quarterly Debt Reduction Obligation (as defined below in Note 7). The failure to make this required payment constituted a Major Trigger Event (as defined below in Note 7) under the March 2025 Note. Subsequent to December 31, 2025, Avondale converted $6,285,000 of principal and accrued interest on the March 2025 Note into 13,510,620 shares of the Company’s common stock. This Major Trigger Event has not resulted in an Event of Default (as defined below in Note 7). Pursuant to the terms of the March 2025 Note, the occurrence of a Major Trigger Event resulted in (i) an automatic 10% increase to the outstanding balance, effective January 1, 2026, and (ii) an adjustment to the Conversion Price (as defined below). Following the adjustment, the Conversion Price is equal to the lesser of the fixed conversion price of $2.26 or 90% of the lowest closing bid price during the three trading days immediately preceding the delivery of a conversion notice, provided that the Conversion Price may not be reduced below the contractual floor price of $0.404. See Note 7 – Debt, for more information related to the March 2025 Note. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. Subsequent to December 31, 2025, the Company sold 5,000,000 shares of common stock under the ATM Agreement (as defined below and described in additional detail in Note 9) and generated $2,425,000 in net proceeds after paying fees to BTIG, LLC (“BTIG”) and other issuance costs of $75,000. Management does not believe that the existing cash and cash equivalents as of December 31, 2025, together with $2,425,000 in net proceeds from the sale of shares of common stock under the ATM Agreement since December 31, 2025, are sufficient to fund the Company’s operations through one year from the date of this Quarterly Report on Form 10-Q. As a result, additional financing will be needed by the Company to fund its operations in the future, fully commercialize ONS-5010/LYTENAVA and to develop any other product candidates. Management is currently evaluating different strategies to obtain the required funding for future operations, including but not limited to, proceeds from potential licensing and/or marketing arrangements or collaborations with pharmaceutical or other companies, sale of the development and commercial rights to the Company’s drug product candidates in regions outside of the U.S., the issuance of additional debt, the issuance of equity securities, including accessing capital through at-the-market offerings (refer to Note 9 for further details), and revenues from product sales. There can be no assurance that any of these future funding efforts will be successful. The Company’s future operations are highly dependent on a combination of factors, including: (i) the timely and successful completion of additional financing discussed above; (ii) the Company’s ability to successfully commercialize ONS-5010/LYTENAVA, including executing marketing arrangements or completing revenue-generating partnerships with other companies; (iii) the success of its research and development; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies; and, ultimately, (v) regulatory approval and market acceptance of the Company’s proposed future products.

Liquidity

3 Months Ended

Dec. 31, 2025

2. Liquidity

The Company has incurred recurring losses and negative cash flows from operations since its inception and has an accumulated deficit of $628,767,898 as of December 31, 2025. As of December 31, 2025, the Company had a working capital deficit. Additionally, the Company has $32,234,985 of principal, accrued interest and exit fees due under an unsecured convertible promissory note issued to Avondale Capital, LLC (“Avondale”) in March 2025 (the “March 2025 Note”), maturing on July 1, 2026. Refer to Note 7 for further details on the March 2025 Note.

On December 31, 2025, the Company did not satisfy the required $3,000,000 Quarterly Debt Reduction Obligation (as defined below in Note 7). The failure to make this required payment constituted a Major Trigger Event (as defined below in Note 7) under the March 2025 Note. Subsequent to December 31, 2025, Avondale converted $6,285,000 of principal and accrued interest on the March 2025 Note into 13,510,620 shares of the Company’s common stock. This Major Trigger Event has not resulted in an Event of Default (as defined below in Note 7).

Pursuant to the terms of the March 2025 Note, the occurrence of a Major Trigger Event resulted in (i) an automatic 10% increase to the outstanding balance, effective January 1, 2026, and (ii) an adjustment to the Conversion Price (as defined below). Following the adjustment, the Conversion Price is equal to the lesser of the fixed conversion price of $2.26 or 90% of the lowest closing bid price during the three trading days immediately preceding the delivery of a conversion notice, provided that the Conversion Price may not be reduced below the contractual floor price of $0.404. See Note 7 – Debt, for more information related to the March 2025 Note.

As a result, there is substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited interim consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

Subsequent to December 31, 2025, the Company sold 5,000,000 shares of common stock under the ATM Agreement (as defined below and described in additional detail in Note 9) and generated $2,425,000 in net proceeds after paying fees to BTIG, LLC (“BTIG”) and other issuance costs of $75,000.

Management does not believe that the existing cash and cash equivalents as of December 31, 2025, together with $2,425,000 in net proceeds from the sale of shares of common stock under the ATM Agreement since December 31, 2025, are sufficient to fund the Company’s operations through one year from the date of this Quarterly Report on Form 10-Q. As a result, additional financing will be needed by the Company to fund its operations in the future, fully commercialize ONS-5010/LYTENAVA and to develop any other product candidates. Management is currently evaluating different strategies to obtain the required funding for future operations, including but not limited to, proceeds from potential licensing and/or marketing arrangements or collaborations with pharmaceutical or other companies, sale of the development and commercial rights to the Company’s drug product candidates in regions outside of the U.S., the issuance of additional debt, the issuance of equity securities, including accessing capital through at-the-market offerings (refer to Note 9 for further details), and revenues from product sales. There can be no assurance that any of these future funding efforts will be successful.

The Company’s future operations are highly dependent on a combination of factors, including: (i) the timely and successful completion of additional financing discussed above; (ii) the Company’s ability to successfully commercialize ONS-5010/LYTENAVA, including executing marketing arrangements or completing revenue-generating partnerships with other companies; (iii) the success of its research and development; (iv) the development of competitive therapies by other biotechnology and pharmaceutical companies; and, ultimately, (v) regulatory approval and market acceptance of the Company’s proposed future products.