Liquidity	3 Months Ended
Dec. 31, 2024
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 $525,907,286 as of December 31, 2024. As of December 31, 2024, the Company had a working capital deficit including $32,229,130 of principal, accrued interest and exit fees due under an unsecured convertible promissory note issued in December 2022 (as amended, the “December 2022 Note”), maturing on July 1, 2025. Refer to Note 7 for further details on the December 2022 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. On January 16, 2025, the Company entered into warrant exercise inducement offer letter agreements with GMS Ventures and Investments (“GMS”), the Company’s largest stockholder, and certain other holders of existing warrants to purchase the Company’s common stock, pursuant to which the holders agreed to exercise their existing warrants (“Existing Warrants”) for an aggregate of 7,074,637 shares of common stock at a reduced exercise price of $2.51 per share. In exchange, the Company issued two new inducement warrants for each Existing Warrant exercised (“Inducement Warrants”), which are exercisable for an aggregate of up to 14,149,274 additional shares of common stock (the “Inducement Warrant Shares”) at an exercise price of $2.26 per share (collectively, the “Warrant Inducement Transaction”). The Company received net proceeds of $15,746,960 after capital markets advisory fees and estimated offering costs, from the Warrant Inducement Transaction. Concurrently with the Warrant Inducement Transaction, the Company entered into a warrant exercise inducement offer letter agreement with Syntone Ventures, LLC (“Syntone”), pursuant to which Syntone agreed to exercise existing warrants (“Existing Syntone Warrants”) for an aggregate of 1,071,429 shares of common stock at a reduced exercise price of $2.51 per share. In exchange, the Company agreed to issue two new inducement warrants for each Existing Syntone Warrant exercised (the "Syntone Inducement Warrants”), which will be exercisable for up to 2,142,858 shares of common stock (the “Syntone Inducement Warrant Shares”) at an exercise price of $2.26 per share (the “Syntone Warrant Inducement Transaction”). The closing of the Syntone Warrant Inducement Transaction is subject to receipt of certain regulatory approvals. The Company expects to generate net proceeds of approximately $2,400,000 after capital markets advisory fees and estimated offering costs. Refer to Note 11 for further details on the Warrant Inducement Transaction and the Syntone Warrant Inducement Transaction. On January 31, 2025, the Company entered into a Securities Purchase Agreement (“SPA”) with Avondale Capital, LLC (“Avondale”), pursuant to which the Company agreed to issue to Avondale an unsecured convertible promissory note for $33,100,000 (the “January 2025 Note”). The Company expects to use the proceeds from the January 2025 Note to repay in full the remaining obligations, including accrued and unpaid interest and the applicable exit fee owed under the December 2022 Note. The December 2022 Note will be cancelled in connection with the issuance of the January 2025 Note. The closing of the transaction (the “Note Closing”) is expected to occur shortly after the Company’s 2025 annual meeting of stockholders, subject to certain closing conditions, including stockholder approval of the issuance of shares of the Company’s common stock in excess of 19.99% of the outstanding common stock upon conversion of the January 2025 Note. Prior to the Note Closing, the Company has agreed not to sell common stock, other than issuances pursuant to the Company’s at-the-market offering, below a per share price of $2.26 and must maintain its Nasdaq listing. The Company has agreed to file a registration statement registering the resale of common stock issuable upon conversion of the January 2025 Note within seven days of the Note Closing. The Company must use commercially reasonable efforts to have the registration statement declared effective within 45 days; otherwise, the outstanding balance on the January 2025 Note will automatically increase by 0.5% monthly until the registration statement is declared effective. The January 2025 Note will bear interest at the prime rate plus 3% (subject to a floor of 9.5%), will be scheduled to mature on July 1, 2026, and will be convertible into common stock. The Company must repay at least $3,000,000 (by cash or conversions into common stock) of the outstanding balance on the January 2025 Note each quarter starting in the second calendar quarter of 2025 (subject to adjustments for conversions and to payment of a 7.5% exit fee) (the “Quarterly Debt Reduction Obligations”). Any amount converted by Avondale during a given calendar quarter in excess of the Quarterly Debt Reduction Obligations will be credited toward meeting the Quarterly Debt Reduction Obligations for the next quarter or quarters. Refer to Note 11 for further details on the January 2025 Note. Management does not believe that the existing cash and cash equivalents as of December 31, 2024, together with net proceeds from the sale of shares of common stock in the Warrant Inducement Transaction, 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 and to commercially develop 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 offering agreements (refer to Note 9 for further details), and revenues from potential future product sales, if any. There can be no assurance that 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 begin marketing of its product candidates or complete 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, 2024

2. Liquidity

The Company has incurred recurring losses and negative cash flows from operations since its inception and has an accumulated deficit of $525,907,286 as of December 31, 2024. As of December 31, 2024, the Company had a working capital deficit including $32,229,130 of principal, accrued interest and exit fees due under an unsecured convertible promissory note issued in December 2022 (as amended, the “December 2022 Note”), maturing on July 1, 2025. Refer to Note 7 for further details on the December 2022 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.

On January 16, 2025, the Company entered into warrant exercise inducement offer letter agreements with GMS Ventures and Investments (“GMS”), the Company’s largest stockholder, and certain other holders of existing warrants to purchase the Company’s common stock, pursuant to which the holders agreed to exercise their existing warrants (“Existing Warrants”) for an aggregate of 7,074,637 shares of common stock at a reduced exercise price of $2.51 per share. In exchange, the Company issued two new inducement warrants for each Existing Warrant exercised (“Inducement Warrants”), which are exercisable for an aggregate of up to 14,149,274 additional shares of common stock (the “Inducement Warrant Shares”) at an exercise price of $2.26 per share (collectively, the “Warrant Inducement

Transaction”). The Company received net proceeds of $15,746,960 after capital markets advisory fees and estimated offering costs, from the Warrant Inducement Transaction.

Concurrently with the Warrant Inducement Transaction, the Company entered into a warrant exercise inducement offer letter agreement with Syntone Ventures, LLC (“Syntone”), pursuant to which Syntone agreed to exercise existing warrants (“Existing Syntone Warrants”) for an aggregate of 1,071,429 shares of common stock at a reduced exercise price of $2.51 per share. In exchange, the Company agreed to issue two new inducement warrants for each Existing Syntone Warrant exercised (the "Syntone Inducement Warrants”), which will be exercisable for up to 2,142,858 shares of common stock (the “Syntone Inducement Warrant Shares”) at an exercise price of $2.26 per share (the “Syntone Warrant Inducement Transaction”). The closing of the Syntone Warrant Inducement Transaction is subject to receipt of certain regulatory approvals. The Company expects to generate net proceeds of approximately $2,400,000 after capital markets advisory fees and estimated offering costs. Refer to Note 11 for further details on the Warrant Inducement Transaction and the Syntone Warrant Inducement Transaction.

On January 31, 2025, the Company entered into a Securities Purchase Agreement (“SPA”) with Avondale Capital, LLC (“Avondale”), pursuant to which the Company agreed to issue to Avondale an unsecured convertible promissory note for $33,100,000 (the “January 2025 Note”). The Company expects to use the proceeds from the January 2025 Note to repay in full the remaining obligations, including accrued and unpaid interest and the applicable exit fee owed under the December 2022 Note. The December 2022 Note will be cancelled in connection with the issuance of the January 2025 Note. The closing of the transaction (the “Note Closing”) is expected to occur shortly after the Company’s 2025 annual meeting of stockholders, subject to certain closing conditions, including stockholder approval of the issuance of shares of the Company’s common stock in excess of 19.99% of the outstanding common stock upon conversion of the January 2025 Note. Prior to the Note Closing, the Company has agreed not to sell common stock, other than issuances pursuant to the Company’s at-the-market offering, below a per share price of $2.26 and must maintain its Nasdaq listing. The Company has agreed to file a registration statement registering the resale of common stock issuable upon conversion of the January 2025 Note within seven days of the Note Closing. The Company must use commercially reasonable efforts to have the registration statement declared effective within 45 days; otherwise, the outstanding balance on the January 2025 Note will automatically increase by 0.5% monthly until the registration statement is declared effective.

The January 2025 Note will bear interest at the prime rate plus 3% (subject to a floor of 9.5%), will be scheduled to mature on July 1, 2026, and will be convertible into common stock. The Company must repay at least $3,000,000 (by cash or conversions into common stock) of the outstanding balance on the January 2025 Note each quarter starting in the second calendar quarter of 2025 (subject to adjustments for conversions and to payment of a 7.5% exit fee) (the “Quarterly Debt Reduction Obligations”). Any amount converted by Avondale during a given calendar quarter in excess of the Quarterly Debt Reduction Obligations will be credited toward meeting the Quarterly Debt Reduction Obligations for the next quarter or quarters. Refer to Note 11 for further details on the January 2025 Note.

Management does not believe that the existing cash and cash equivalents as of December 31, 2024, together with net proceeds from the sale of shares of common stock in the Warrant Inducement Transaction, 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 and to commercially develop 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 offering agreements (refer to Note 9 for further details), and revenues from potential future product sales, if any. There can be no assurance that 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 begin marketing of its product candidates or complete 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.