Onconetix, Inc. 10-Q

Item 1A. Risk Factors In addition to the following risk factors, you should carefully consider the risk factors included in our Annual Report on Form 10-K, filed with the SEC on June 2, 2025, as supplemented and updated by subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K that we have filed or will file with the SEC. Any of these factors could result in a significant or material adverse effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. Risks Related to our Financial Position and Need for Capital We have incurred significant net losses since inception, have only generated minimal revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve profitability. Our stock is a highly speculative investment. We are a commercial-stage biotechnology company that was incorporated in October 2018. Our net loss was $19.7 million for the nine months ended September 30, 2025. As of September 30, 2025, we had an accumulated deficit of $136.9 million. We also generated negative operating cash flows of $6.6 million for the nine months ended September 30, 2025. We expect to continue to spend significant resources to commercialize our product. We expect to incur substantial and increasing operating losses over the next several years. As a result, our accumulated deficit will also increase significantly. Additionally, there can be no assurance that our current product or those that may be under development by us in the future will be commercially viable. If we are unable to achieve profitability or raise sufficient working capital, we may be unable to continue our operations. There is substantial doubt about our ability to continue as a “going concern,” and we will require substantial additional funding to finance our long-term operations. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate our product or other operations. The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of September 30, 2025, the Company had cash of approximately $0.8 million, a working capital deficit of approximately $15.0 million and an accumulated deficit of approximately $136.9 million. In addition, as of November 10, 2025, the Company’s cash balance was approximately $6.1 million, and the Company has approximately $0.2 million of debt due within the next 12 months. We estimate, as of the date of this Report, that our current cash balance is not sufficient to fund operations over the next twelve months. We believe that we will need to raise substantial additional capital to fund our continuing operations, satisfy existing and future obligations and liabilities, and otherwise support the Company’s working capital needs and business activities, including the commercialization of Proclarix, which is still subject to further successful development and commercialization activities within certain jurisdictions. Management also intends to secure additional required funding through equity or debt financings if available. In December 2024, the Company began utilizing the ELOC entered into in October 2024 (see Note 9) on an as-needed basis to fund current operating needs, subject to certain restrictions and beneficial ownership constraints. However, based on the terms of the ELOC and the current maximum availability, management determined that the funds readily available under the ELOC will not be sufficient to raise substantial additional capital to fund our continuing operations, satisfy existing and future obligations and liabilities, and otherwise support the Company’s working capital needs and business activities and . The commercialization of Proclarix, which is still subject to further successful development and commercialization activities within certain jurisdictions. If the Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization of future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations, or, if its required to, file for bankruptcy. 52 These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of time within one year following the date of this Report. Our future capital requirements will depend on many factors, including: ● the costs of future development and commercialization activities, including product manufacturing, marketing, sales, royalties and distribution, for Proclarix, and other products for which we have received or will receive marketing approval; ● our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty, or other payments due under any such agreement; ● any product liability or other lawsuits related to our product; ● the expenses needed to attract, hire, and retain skilled personnel; ● the revenue, if any, received from commercial sales of Proclarix or other products for which we may receive marketing approval; ● the costs to establish, maintain, expand, enforce, and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending, and enforcing our patents or other intellectual property rights; and ● the costs of operating as a public company. Our ability to raise additional funds will depend on financial, economic, and other factors, many of which are beyond our control. We cannot be certain that additional funding will be available on acceptable terms, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be forced to delay, reduce or terminate our business activities. Our current liabilities are significant, and if those to whom we owe accounts payable, were to demand payment, we would be unable to pay. As of September 30, 2025, we had total current liabilities of approximately $16.3 million, including accounts payable of approximately $1.8 million, accrued expenses of approximately $0.5 million, warrant liabilities of $12.8 million, derivative liabilities of approximately $1.0 million, and approximately $0.2 million (net of discounts) related to the notes payable. As of the same date, we had cash of only $0.8 million. In September 2025, we have completed a Series D financing, which satisfied all amounts due under the Veru notes, and we plan to seek additional funding as necessary to support our operations and growth initiatives. However, the level of our current liabilities may make it more difficult for us to obtain adequate financing on favorable terms, if at all. If those to whom these payments are due were to demand immediate payment, as they are entitled to do, and we are not able to make the required payments, we would be subject to liability if our creditors chose to enforce their rights, which could result in our bankruptcy and insolvency. Under such a scenario, our assets would be distributed to our creditors leaving nothing to be distributed to our stockholders. Item 2. Unregistered Sales of Equity Securities and Use of Proceeds There are no transactions that have not been previously included in a Current Report on Form 8-K. Issuer Purchases of Equity Securities None. Item 3. Default Upon Senior Securities None. Item 4. Mine Safety Disclosures Not applicable.