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Onconetix, Inc.

For the period ended Jun 30, 2025. Filed Aug 14, 2025.

View on SEC.gov

About 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.

Jun 30, 2025 · Filed Aug 14, 2025

ONCO$6.95+26.6%Stored close · as of Nov 6, 2026

What changed in Risk Factors?

Read the current filing

The 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 38 previous paragraphs and 54 current paragraphs.

22 unchanged; 7 reworded; 25 added; 9 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 3 previous and 9 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 (25)

Current report

Neither Onconetix nor Ocuvex can be sure if or when the Merger will be completed.

Current report

The consummation of the Merger is subject to the satisfaction or waiver of various conditions. Neither Onconetix nor Ocuvex can guarantee that the closing conditions set forth in the Merger Agreement will be satisfied. If Onconetix is unable to satisfy the closing conditions in Ocuvex’s favor or if other mutual closing conditions are not satisfied, Ocuvex will not be obligated to complete the Merger. Under certain circumstances, Onconetix would be required to pay Ocuvex a termination fee equal to the greater of (i) $250,000 and (ii) all costs and expenses incurred by Ocuvex in connection with the Merger Agreement and the Transactions, including, without limitation, all reasonable attorneys’ fees.

Current report

If the Merger is not completed, the Onconetix Board, in discharging its fiduciary obligations to Onconetix stockholders, will evaluate other strategic alternatives or financing options that may be available, which alternatives may not be as favorable to Onconetix stockholders as the Merger. Any future sale or merger, financing or other transaction may be subject to further stockholder approval. Onconetix may also be unable to find, evaluate or complete other strategic alternatives, which may have a materially adverse effect on Onconetix’s business.

Current report

Onconetix’s and Ocuvex’s efforts to complete the Merger could cause substantial disruptions in, and create uncertainty surrounding, their respective businesses, which may materially adversely affect their results of operation and businesses. Uncertainty as to whether the Merger will be completed may affect Onconetix’s and Ocuvex’s ability to retain and motivate existing employees. A substantial amount of Onconetix’s and Ocuvex’s management’s and employees’ attention is being directed toward the completion of the Merger and thus is being diverted from their respective day-to-day operations. Uncertainty as to Onconetix’s and Ocuvex’s future could adversely affect their relationship with customers, collaborators, suppliers, vendors, regulators and other business partners. For example, customers, vendors, collaborators and other counterparties may defer decisions concerning working with Onconetix or Ocuvex, or seek to change existing business relationships with Onconetix or Ocuvex. Changes to, or termination of, existing business relationships could adversely affect Onconetix’s results of operations and financial condition, as well as the market price of Onconetix common stock. The adverse effects of the pendency of the Merger could be exacerbated by any delays in completion of the Merger or termination of the Merger Agreement.

Current report

Until the Merger is completed, the Merger Agreement restricts Ocuvex and Onconetix from taking specified actions without the consent of the other party, and requires them to operate in the ordinary course of business consistent with past practice. These restrictions may prevent Ocuvex and Onconetix from making appropriate changes to their respective businesses or pursuing attractive business opportunities that may arise prior to the completion of the Merger.

Current report

Failure to complete the Merger may result in Onconetix paying a termination fee to Ocuvex and could significantly harm the market price of the Onconetix common stock and negatively affect Onconetix’s future business and operations.

Current report

If the Merger is not completed and the Merger Agreement is terminated under certain circumstances, Onconetix may be required to pay Ocuvex a termination fee equal to the greater of (i) $250,000 and (ii) all costs and expenses incurred by Ocuvex in connection with the Merger Agreement and the Transactions, including, without limitation, all reasonable attorneys’ fees. Even if a termination fee is not payable in connection with a termination of the Merger Agreement, Onconetix will have incurred significant fees and expenses, which must be paid whether or not the Merger is completed. Further, if the Merger is not completed, it could significantly harm the market price of the Onconetix common stock.

Current report

In addition, if the Merger Agreement is terminated and Onconetix determines to seek another business combination, there can be no assurance that Onconetix will be able to find a partner and close an alternative transaction on terms that are as favorable as or more favorable to Onconetix than the terms set forth in the Merger Agreement.

Current report

The closing of the Merger is subject to approval by Onconetix stockholders and the Ocuvex stockholders. Failure to obtain these approvals would prevent the closing of the Merger.

Current report

The closing of the Merger is subject to certain approvals by the Onconetix stockholders and the Ocuvex stockholders. Failure to obtain the required stockholder approvals may result in a material delay in, or the abandonment of, the Merger. Any delay in completing the Merger may materially adversely affect the timing and benefits that are expected to be achieved from the Merger.

Current report

The Merger may be completed even though certain events occur prior to the Closing that materially and adversely affect Onconetix or Ocuvex.

Current report

The Merger Agreement provides that either Onconetix or Ocuvex can refuse to complete the Merger if (i) if there is a material breach of any of the representations or warranties of the other party set forth in the Merger Agreement or if the other party has failed to perform any covenant or agreement on the part of such party set forth in the Merger Agreement that has not been cured within 20 days or is incapable of being cured, subject to specified limitations, (ii) the failure of the Transactions to be consummated by the date that is six months after the Audit Delivery Date (as defined in the Merger Agreement), (iii) the imposition of a governmental order permanently enjoining or otherwise prohibiting the Transactions or (iv) the failure to obtain the required approval of Onconetix’s stockholders. However, certain events may occur that do not permit either party to refuse to complete the Merger, even if such events could be said to have a material adverse effect on Onconetix or Ocuvex, including, but not limited to:

Current report

If the combined company is unable to realize the strategic and financial benefits currently anticipated from the Merger, Onconetix stockholders will have experienced substantial dilution of their ownership interests in Onconetix without receiving the expected commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined company is able to realize only part of the expected strategic and financial benefits currently anticipated from the Merger.

Current report

During the pendency of the Merger, Onconetix may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect Onconetix’s business.

Current report

Covenants in the Merger Agreement impede the ability of Onconetix to enter into material transactions that are not in the ordinary course of business pending completion of the Merger. As a result, if the Merger is not completed, Onconetix may be at a disadvantage to its competitors during such period. In addition, while the Merger Agreement is in effect, Onconetix generally prohibited from soliciting, initiating, encouraging or entering into certain extraordinary transactions, such as a merger, sale of assets, or other business combination with any third party, subject to certain exceptions relating to fiduciary duties. Any such transactions that are impeded or prohibited pursuant to these covenants could be favorable to Onconetix stockholders if consummated.

Current report

The Merger Agreement contains “no-shop” restrictions on Onconetix’s ability to solicit, initiate, endorse, knowingly encourage or facilitate third party proposals relating to alternative transactions or to provide information to, or engage in discussions with, a third party in relation to an alternative transaction, subject to certain exceptions to permit the Onconetix Board to comply with its fiduciary duties. Before the Onconetix Board may change its recommendation to stockholders to adopt the Merger or terminate the Merger Agreement to accept a Parent Superior Proposal (as defined in the Merger Agreement), Onconetix must, among other things, provide Ocuvex with notice and matching rights. Upon the termination of the Merger Agreement, including in connection with a Parent Superior Proposal, Onconetix may be required to pay a termination fee.

Current report

These provisions could discourage a potential third party acquiror from considering or proposing an acquisition transaction, even if it were prepared to pay a higher price than what would be received in the Merger. These provisions might also result in a potential third party acquiror proposing to pay a lower price than it might otherwise have proposed to pay because of the added expense of the termination fee that may become payable.

Current report

If the Merger Agreement is terminated and Onconetix determines to seek another business combination, Onconetix may not be able to negotiate a transaction with another party on terms comparable to, or better than, the terms of the Merger Agreement.

Current report

Litigation relating to the Merger could require Onconetix or Ocuvex to incur significant costs and suffer management distraction, and could delay or enjoin the Merger.

Current report

Onconetix or Ocuvex could be subject to demands or litigation related to the Merger, whether or not the Merger is consummated. Such actions may create uncertainty relating to the Merger, or delay or enjoin the Merger, and responding to such demands could divert management time and resources. In addition, such demands or litigation could lead to a dissolution or bankruptcy of Onconetix if the costs associated with such demands or litigation are significant enough.

Current report

If the Merger is not completed, the Onconetix Board may decide to pursue a dissolution and liquidation of Onconetix. In such an event, the amount of cash available for distribution to its stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

Current report

There can be no assurance that the Merger will be completed. If the Merger is not completed, the Onconetix Board may decide to pursue a dissolution and liquidation of Onconetix. In such an event, the amount of cash available for distribution to Onconetix stockholders will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution will be reduced as Onconetix continues to fund its operations. In addition, if the Onconetix Board were to approve and recommend, and Onconetix stockholders were to approve, a dissolution and liquidation of Onconetix, Onconetix would be required under Delaware corporate law to pay its outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to Onconetix stockholders. As a result of this requirement, a portion of Onconetix’s remaining cash assets may need to be reserved pending the resolution of such obligations. In addition, Onconetix may be subject to litigation or other claims related to a dissolution and liquidation. If a dissolution and liquidation were pursued, the Onconetix Board, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of Onconetix common stock could lose all or a significant portion of their investment in the event of liquidation, dissolution or winding up of Onconetix.

Current report

Following the completion of the Merger, the combined company may issue additional securities.

Current report

Following the completion of the Merger, the combined company may issue additional securities (including equity securities) to finance its activities. If the combined company were to issue additional equity securities, the ownership interest of existing Onconetix and Ocuvex stockholders may be diluted and some or all of the combined company’s financial measures on a per share basis could be reduced. Moreover, as the combined company’s intention to issue additional equity securities becomes publicly known, the combined company’s share price may be materially adversely affected.
Removed paragraphs (9)

Previous report

If completed, the Ocuvex Business Combination may not achieve its intended results and may result in us assuming unanticipated liabilities.

Previous report

We entered into the Ocuvex LOI with the expectation that the Ocuvex Business Combination would result in various benefits and growth opportunities. Achieving the anticipated benefits of the transaction is subject to a large number of risks and uncertainties, including our ability to raise the substantial capital required for the Ocuvex Business Combination. Additionally, the success of the Ocuvex Business Combination depends on, among other things, the accuracy of our assessment of the assets associated with the acquired assets, operating costs and various other factors. These assessments are necessarily inexact. As a result, we may not recover the purchase price for the acquisition or recognize an acceptable return on sales.

Previous report

The transactions contemplated by the Ocuvex LOI are subject to conditions that may not be satisfied on a timely basis or at all. Failure to complete the transactions contemplated by the Ocuvex LOI could have material and adverse effects on us.

Previous report

Completion of the Ocuvex Business Combination is subject to a number of conditions, including the accuracy of the parties’ representations in the transactions as contemplated by the Ocuvex LOI. Such conditions, some of which are beyond our control, may not be satisfied or waived in a timely manner or at all and therefore make the completion and timing of the completion of the Ocuvex Business Combination uncertain. In addition, the Ocuvex LOI contains certain termination rights for both parties, which if exercised will also result in the Ocuvex Business Combination not being consummated.

Previous report

If the transactions contemplated by the Ocuvex LOI are not completed, our business may be adversely affected and, without realizing any of the benefits of having completed the Ocuvex Business Combination, we will be required to pay our costs relating to the Ocuvex Business Combination, such as legal, accounting, and financial advisory fees. In addition, time and resources committed by our management to matters relating to the Ocuvex Business Combination could otherwise have been devoted to pursuing other beneficial opportunities; and the market price of our common stock could be impacted to the extent that the current market price reflects a market assumption that the Ocuvex Business Combination will be completed.

Previous report

We will be subject to business uncertainties while the Ocuvex Business Combination is pending, which could adversely affect our business.

Previous report

It is possible that certain persons with whom we have a business relationship may delay certain business decisions relating to us, or seek to terminate, change or renegotiate their relationships with us, in connection with the pendency of the Ocuvex Business Combination. This could negatively affect our revenues, earnings and cash flows, as well as the market price of our common stock, regardless of whether the Ocuvex Business Combination is completed.

Previous report

On June 12, 2025, the Company filed a Certificate of Correction (the “Correction”) to the Certificate of Designation, Preferences and Rights of Series C Convertible Preferred Stock originally filed on October 2, 2024 (the “Certificate”). Due to a scrivener’s error, Section 9 of the original Certificate erroneously only provided for redemptions of all, and not less than all, of the Series C Convertible Preferred Stock.

Previous report

The foregoing description of the Correction does not purport to be complete and is qualified in its entirety by reference to the full text of the Correction, which is filed as Exhibit 3.7 to this Quarterly Report on Form 10-Q and incorporated by reference herein.
Reworded paragraphs (7)

Previous wording

We are a commercial-stage biotechnology company that was incorporated in October 2018. Our net loss was $8.5 million for the three months ended March 31, 2025. As of March 31, 2025, we had an accumulated deficit of $125.4 million. We also generated negative operating cash flows of $2.0 million for the three months ended March 31, 2025.

Current wording

We are a commercial-stage biotechnology company that was incorporated in October 2018. Our net loss was $10.9 million for the six months ended June 30, 2025. As of June 30, 2025, we had an accumulated deficit of $128.1 million. We also generated negative operating cash flows of $3.4 million for the six months ended June 30, 2025.

Previous wording

The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of March 31, 2025, the Company had cash of approximately $1.6 million, a working capital deficit of approximately $11.6 million and an accumulated deficit of approximately $125.4 million. In addition, as of June 10, 2025, the Company’s cash balance was approximately $0.4 million, and the Company has approximately $9.0 million of debt due within the next 12 months.

Current wording

The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of June 30, 2025, the Company had cash of approximately $0.3 million, a working capital deficit of approximately $11.8 million and an accumulated deficit of approximately $128.1 million. In addition, as of August 13, 2025, the Company’s cash balance was approximately $0.2 million, and the Company has approximately $8.7 million of debt due within the next 12 months.

Previous wording

Due to recent financial constraints, the Company may be unable to timely pay amounts due to Veru, from whom we purchased ENTADFI in April 2023. We may not have sufficient funds to pay amounts due to Veru in the near term, if at all, including but not limited to $10 million, $5 million of which was due on April 19, 2024 and is subject to certain forbearance terms and $5 million of which was due on March 31, 2025, and is subject to certain forbearance terms. On April 24, 2024, Veru agreed to forbear its rights and remedies until March 31, 2025, which forbearance period was further extended until June 30, 2025 by limited waiver on March 31, 2025 and April 24, 2025, with respect to, among other things, our inability to pay amounts due on April 19, 2024, and on September 19, 2024, Veru agreed to forbear its rights and remedies until June 30, 2025 with respect to, among other things, our inability to pay amounts due on September 30, 2024. In addition, on November 26, 2024, the Company and Veru entered into a waiver and amendment to the forbearance agreement, pursuant to which Veru agreed to waive the due date for payment of applicable Company cash receipt payments generated in October 2024 in consideration for an increase in payments to be made to Veru out of future financing and strategic transactions through June 30, 2025. However, Veru may take future action against us, including filing legal proceedings against us seeking amounts due and interest accrued or attempting to terminate its relationship with us. If Veru were to take legal action against us, we may be forced to scale back our business plan and/or seek bankruptcy protection. We may be subject to litigation and damages for our failure to pay amounts due to Veru, and may be forced to pay interest and penalties, which funds we do not currently have.

Current wording

Due to recent financial constraints, the Company may be unable to timely pay amounts due to Veru, from whom we purchased ENTADFI in April 2023. We may not have sufficient funds to pay amounts due to Veru in the near term, if at all, including but not limited to $10 million, $5 million of which was due on April 19, 2024 and is subject to certain forbearance terms and $5 million of which was due on June 30, 2025, and is subject to certain forbearance terms. In addition, on November 26, 2024, the Company and Veru entered into a waiver and amendment to the forbearance agreement, pursuant to which Veru agreed to waive the due date for payment of applicable Company cash receipt payments generated in October 2024 in consideration for an increase in payments to be made to Veru out of future financing and strategic transactions through June 30, 2025. In addition, On March 31, 2025, April 23, 2025, June 30, 2025 and July 31, 2025, Veru and the Company entered into waiver agreements, pursuant to which Veru agreed to waive and extend the date for payment of the Veru Notes. On August 7, 2025, Veru and the Company entered into the A&R September Veru Note, pursuant to which the principal amount owed to Veru under the September Veru Note was increased by $100,000 to an aggregate principal amount of $5.1 million, and the maturity date was amended to August 14, 2025. However, Veru may take future action against us, including filing legal proceedings against us seeking amounts due and interest accrued or attempting to terminate its relationship with us. If Veru were to take legal action against us, we may be forced to scale back our business plan and/or seek bankruptcy protection. We may be subject to litigation and damages for our failure to pay amounts due to Veru, and may be forced to pay interest and penalties, which funds we do not currently have.

Previous wording

In light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets. There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product.

Current wording

In light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is in the process of destroying its inventory of the product.

Previous wording

As of March 31, 2025, we had total current liabilities of approximately $14.0 million, including accounts payable of approximately $3.0 million, accrued expenses of approximately $1.2 million, the related party subscription liability of $0.8 million, proceeds due to shareholders of $0.4 million, and approximately $9.0 million (net of discounts) related to the notes payable. As of the same date, we had cash of only $1.6 million. In light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets. There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product. We plan to seek funding to support our operations. We have also concurrently reduced our liabilities by entering into a settlement agreement, dated January 15, 2025, with IQVIA, Inc. concerning potential termination payments, whereby we recorded an adjustment of approximately ($0.9) million in accounts payable. 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.

Current wording

As of June 30, 2025, we had total current liabilities of approximately $12.7 million, including accounts payable of approximately $2.6 million, accrued expenses of approximately $0.9 million, proceeds due to shareholders of $0.4 million, and approximately $8.7 million (net of discounts) related to the notes payable. As of the same date, we had cash of only $0.3 million. In light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is in the process of destroying its inventory of the product. We plan to seek funding to support our operations. We have also concurrently reduced our liabilities by entering into a settlement agreement, dated January 15, 2025, with IQVIA, Inc. concerning potential termination payments, whereby we recorded an adjustment of approximately ($0.9) million in accounts payable. 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.

Previous wording

We expect to incur significant transaction costs in connection with the Ocuvex Business Combination.

Current wording

We expect to incur significant transaction costs in connection with the Merger.

Previous wording

We expect to incur a number of non-recurring costs associated with negotiating and completing the Ocuvex Business Combination. These fees and costs have been, and will continue to be, substantial and, in many cases, will be borne by us whether or not the Ocuvex Business Combination is completed. A substantial majority of our non-recurring expenses will consist of transaction costs related to the Ocuvex Business Combination and include, among others, fees paid to financial, legal, accounting and other advisors. We will continue to assess the magnitude of these costs, and we may incur additional unanticipated costs. The costs described above and any unanticipated costs and expenses, many of which will be borne by us even if the Ocuvex Business Combination is not completed, could have an adverse effect on our financial condition and operating results.

Current wording

We expect to incur a number of non-recurring costs associated with completing the Merger. These fees and costs have been, and will continue to be, substantial and, in many cases, will be borne by us whether or not the Merger is completed. A substantial majority of our non-recurring expenses will consist of transaction costs related to the Merger and include, among others, fees paid to financial, legal, accounting and other advisors. We will continue to assess the magnitude of these costs, and we may incur additional unanticipated costs. The costs described above and any unanticipated costs and expenses, many of which will be borne by us even if the Merger is not completed, could have an adverse effect on our financial condition and operating results.