☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) (Former name, former address and former fiscal year, if changed since last report) Securities registered pursuant to Section 12(b) of the Act: For the transition period from to Commission Fi ...

Core Viewpoint - Monteverde & Associates PC is investigating Onconetix, Inc. regarding its merger with Ocuvex Therapeutics, Inc., where Ocuvex shareholders will own approximately 90% of the combined company and Onconetix shareholders will own approximately 10% [1] Group 1 - Monteverde & Associates PC has recovered millions for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report [1] - The proposed transaction involves an exchange of Ocuvex shares for Onconetix shares based on a defined exchange ratio [1] - The firm is headquartered in the Empire State Building, New York City [1] Group 2 - The firm emphasizes that it litigates and has a successful track record in trial and appellate courts, including the U.S. Supreme Court [2] - The firm offers free consultations for shareholders with concerns regarding the merger [3]

Core Viewpoint - Onconetix, Inc. has entered into a definitive merger agreement with Ocuvex Therapeutics, Inc., aiming to enhance its portfolio with ophthalmic therapeutic candidates and create significant value for shareholders [1][2]. Company Overview Onconetix - Onconetix is a commercial stage biotechnology company focused on innovative solutions for men's health and oncology, including the Proclarix® diagnostic test for prostate cancer [6]. Ocuvex - Ocuvex is a privately held biopharmaceutical company specializing in ophthalmic therapeutic candidates, with its lead asset, Omlonti® (omidenepag isopropyl ophthalmic solution) 0.002%, approved by the FDA for ocular hypertension and open-angle glaucoma [8]. Transaction Details - The merger agreement has been approved by the boards of directors of both companies, with Onconetix acquiring all equity interests of Ocuvex [3][4]. - Ocuvex equity holders will receive newly-issued shares of Onconetix common stock equal to 90% of the combined company’s equity interests post-transaction, while Onconetix shareholders will retain 10% [4]. - The board of directors of the combined company will consist of seven directors, with five from Ocuvex and two from Onconetix [5]. Anticipated Timeline - The completion of the proposed transaction is expected in the fourth quarter of 2025, subject to customary conditions including regulatory and stockholder approvals [5].

Core Viewpoint - Onconetix, Inc. has received approval from the Nasdaq Hearings Panel for continued listing on The Nasdaq Stock Market, contingent upon compliance with specific Nasdaq Listing Rules by set deadlines [1][2]. Group 1: Compliance and Listing Status - On June 11, 2025, Onconetix was granted a decision for continued listing, requiring compliance with the Periodic Filing Listing Rule by June 13, 2025, and the Bid Price Listing Rule by June 30, 2025 [1]. - The company demonstrated compliance with the Periodic Filing Listing Rule on June 12, 2025, by filing the Form 10-Q for the period ended March 31, 2025 [2]. - A 1-for-85 reverse stock split of its outstanding shares was completed on June 13, 2025, to help meet listing requirements [2]. Group 2: Company Overview - Onconetix, Inc. is a commercial-stage biotechnology company focused on innovative solutions for men's health and oncology [3]. - The company owns Proclarix, an in vitro diagnostic test for prostate cancer, which is approved for sale in the European Union [3].

PART I. [FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) This section presents the unaudited condensed consolidated financial statements, detailing financial position, operational results, and cash flows, highlighting a net loss and working capital deficit [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $18.8 million due to a $10.9 million goodwill impairment, resulting in a $11.6 million working capital deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $1,577 | $647 | | Total Current Assets | $2,421 | $950 | | Goodwill | $16,210 | $27,049 | | **Total Assets** | **$18,776** | **$28,182** | | **Liabilities & Equity** | | | | Notes Payable, net | $8,956 | $9,328 | | Total Current Liabilities | $14,039 | $18,290 | | **Total Liabilities** | **$14,258** | **$18,571** | | **Total Stockholders' Equity** | **$3,993** | **$8,543** | - Goodwill decreased from **$27.0 million** to **$16.2 million** due to an impairment loss of **$10.9 million** during the quarter[63](index=63&type=chunk)[65](index=65&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported an $8.5 million net loss, impacted by a $10.9 million goodwill impairment, despite a $4.0 million increase in other income Q1 2025 vs. Q1 2024 Statement of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenue | $101.6 | $700.4 | | Gross Profit | $45.8 | $189.0 | | Impairment of goodwill | $10,918.0 | $5,192.0 | | Loss from operations | $(12,570.8) | $(11,082.0) | | **Net Loss** | **$(8,545.9)** | **$(11,118.6)** | | Net loss per share, basic and diluted | $(0.53) | $(20.08) | - A significant goodwill impairment of **$10.9 million** was recorded in Q1 2025, compared to **$5.2 million** in Q1 2024[17](index=17&type=chunk) - Total other income was **$4.0 million** in Q1 2025, primarily due to a **$3.3 million** change in fair value of a subscription agreement liability and a **$0.9 million** gain on forgiveness of accounts payable[17](index=17&type=chunk)[68](index=68&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $2.0 million, offset by $2.9 million from financing activities, resulting in a $0.9 million cash increase Q1 2025 vs. Q1 2024 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,999.7) | $(5,232.1) | | Net cash provided by (used in) investing activities | $0 | $(4.6) | | Net cash provided by financing activities | $2,870.3 | $5,205.1 | | **Net increase (decrease) in cash** | **$930.7** | **$(90.5)** | - Financing activities in Q1 2025 included **$5.0 million** in proceeds from the issuance of common stock via the ELOC, offset by a **$1.3 million** payment for the redemption of Series C Preferred Stock[23](index=23&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes detail accounting policies, strategic shifts, debt agreements, equity financing, and material weaknesses in internal controls - **Going Concern:** The company has substantial doubt about its ability to continue as a going concern. As of March 31, 2025, cash was **$1.6 million** with a working capital deficit of **$11.6 million**. The current cash balance is **insufficient to fund operations through June 2026** without additional financing[35](index=35&type=chunk)[37](index=37&type=chunk) - **Strategic Shift:** The company has halted vaccine development and abandoned commercialization of ENTADFI to focus on its Proclarix diagnostic product for prostate cancer[28](index=28&type=chunk)[186](index=186&type=chunk) - **Debt and Forbearance:** The company has **two $5.0 million notes** payable to Veru. It failed to repay the first note and entered into forbearance agreements, extending the due dates to June 30, 2025, with modified payment terms[75](index=75&type=chunk)[77](index=77&type=chunk)[84](index=84&type=chunk) - **Financing:** The company is utilizing a Common Stock Equity Line of Credit (ELOC) to raise capital. As of June 12, 2025, it had sold shares for gross proceeds of approximately **$6.2 million** under the agreement[122](index=122&type=chunk)[178](index=178&type=chunk) - **Subsequent Events:** On April 8, 2025, the company announced a non-binding letter of intent for a potential business combination with Ocuvex Therapeutics. On June 11, 2025, it announced a 1-for-85 reverse stock split[177](index=177&type=chunk)[181](index=181&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses financial condition, strategic focus on Proclarix, significant revenue decrease, and reiterates going concern doubt - The company has abandoned commercialization of ENTADFI due to the resources required and its cash runway, and is now focusing its efforts on commercializing Proclarix[186](index=186&type=chunk)[188](index=188&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern. The cash balance was approximately **$0.4 million** as of June 10, 2025, which is **not sufficient to fund operations through the end of December 2025**[248](index=248&type=chunk)[284](index=284&type=chunk) Q1 2025 vs. Q1 2024 Results of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $101.6 | $700.4 | $(598.8) | (85.5)% | | Selling, general and administrative | $1,674.2 | $3,736.5 | $(2,062.2) | (55.2)% | | Impairment of goodwill | $10,918.0 | $5,192.0 | $5,726.0 | 110.3% | | Net loss | $(8,545.9) | $(11,118.6) | $2,572.7 | (23.1)% | - The decrease in SG&A expenses by **$2.1 million** was mainly due to a **$0.8 million** reduction in non-recurring professional fees related to the Proteomedix acquisition in 2024 and a **$0.4 million** decrease in payroll-related expenses[240](index=240&type=chunk) - Management plans to secure additional funding through equity or debt financing and utilize the ELOC, but acknowledges that funds available under the ELOC will not be sufficient to sustain operations[249](index=249&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Onconetix is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Onconetix is not required to provide quantitative and qualitative disclosures about market risk[269](index=269&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded disclosure controls were ineffective due to material weaknesses in internal control over financial reporting - Management concluded that the Company's disclosure controls and procedures were **not effective** as of March 31, 2025[270](index=270&type=chunk) - Several material weaknesses were identified, including: - Inadequate segregation of duties - Ineffective risk assessment and monitoring - Insufficient accounting resources for complex transactions and timely reporting - Ineffective Information Technology General Controls (ITGCs) related to user access, change management, and data security[272](index=272&type=chunk) - A remediation plan is being implemented, focusing on improving the control environment, enhancing policies and procedures, implementing effective review controls, and ensuring proper segregation of duties[274](index=274&type=chunk) PART II. [OTHER INFORMATION](index=46&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings.) Onconetix is not subject to any material legal proceedings or aware of any threatened material legal actions - The company is not currently subject to any material legal proceedings[280](index=280&type=chunk) [Item 1A. Risk Factors](index=46&type=page&id=Item%201A.%20Risk%20Factors.) Significant risks include a history of net losses, substantial doubt about going concern, urgent need for capital, and risks from the Ocuvex business combination - **Going Concern and Financial Health:** The company has a history of significant net losses (**$8.5M** for Q1 2025) and an accumulated deficit of **$125.4M**. There is substantial doubt about its ability to continue as a going concern, with a cash balance of only **$0.4M** as of June 10, 2025[282](index=282&type=chunk)[284](index=284&type=chunk) - **Debt to Veru:** The company owes a significant amount to Veru (approximately **$9.0 million**) and may be unable to make timely payments, despite forbearance agreements. Failure to pay could lead to legal action, forced scale-back of operations, or bankruptcy[288](index=288&type=chunk)[291](index=291&type=chunk) - **Pending Ocuvex Business Combination:** The potential merger with Ocuvex Therapeutics is subject to numerous risks, including failure to complete the transaction, assuming unanticipated liabilities, and incurring substantial non-recurring transaction costs[293](index=293&type=chunk)[294](index=294&type=chunk)[297](index=297&type=chunk) - **Need for Capital:** The company requires substantial additional funding to finance operations. Funds from the ELOC are not expected to be sufficient, and there is no assurance that other financing will be available on acceptable terms, if at all[286](index=286&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) No unregistered sales of equity securities were reported during the period that were not previously disclosed - There were no unregistered sales of equity securities that have not been previously reported on a Form 8-K[298](index=298&type=chunk) [Item 5. Other Information](index=48&type=section&id=Item%205.%20Other%20Information.) A Certificate of Correction was filed to fix a scrivener's error regarding Series C Preferred Stock redemption terms - A Certificate of Correction was filed on June 12, 2025, to correct a scrivener's error in the Certificate of Designation for the Series C Convertible Preferred Stock, allowing for partial redemptions[302](index=302&type=chunk) [Item 6. Exhibits](index=49&type=section&id=Item%206.%20Exhibits.) This section provides an index of exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents

Core Viewpoint - Onconetix, Inc. has announced a reverse stock split of 1-for-85 shares, approved by stockholders, to regain compliance with Nasdaq's minimum bid price requirement of $1.00 per share, effective June 13, 2025 [1][3][5] Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 44.4 million to about 521,863 [5] - The split will be executed automatically, converting every 85 shares into one share without changing the par value, and no fractional shares will be issued [4] - Fractional shares will be compensated in cash based on the closing price on June 12, 2025 [4] Group 2: Company Overview - Onconetix, Inc. is a commercial-stage biotechnology company focused on men's health and oncology, owning products like Proclarix and ENTADFI [6] - Proclarix is an in vitro diagnostic test for prostate cancer, while ENTADFI is an FDA-approved treatment for benign prostatic hyperplasia [6]

Financial Performance - As of December 31, 2024, the company reported a working capital deficit of approximately $17.3 million and an accumulated deficit of approximately $113.0 million[28]. - The company has incurred net losses since inception and expects to continue doing so, with significant fluctuations in losses depending on various operational activities[28]. - The company incurred a net loss of $58.7 million and $37.4 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $115.7 million as of December 31, 2024[198]. - The company generated negative operating cash flows of $10.5 million for the year ended December 31, 2024[198]. - The company has cash of only $0.6 million, which raises concerns about its ability to meet current liabilities[208]. Product Development and Commercialization - The company has generated revenue only from Proclarix since its acquisition, while ENTADFI has not generated any revenue and commercialization activities have been abandoned[27]. - The company is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets, with no current plans to resume its commercialization[25]. - The company has abandoned the commercialization of ENTADFI due to cash runway and indebtedness, and the assets were fully impaired as of June 30, 2024[73]. - Proclarix is an in vitro diagnostic test for prostate cancer, approved for sale in the European Union, and aims to reduce unnecessary biopsies by providing a risk score for patients with elevated PSA levels[48]. - Proclarix is designed to aggregate multimodal information to develop a patient-centric diagnostic approach, with plans to enhance the risk score with additional biomarkers in the future[48]. Acquisitions and Partnerships - The acquisition of Proteomedix was completed on December 15, 2023, providing Proteomedix shareholders with an initial 16.4% ownership stake in the company[45]. - The acquisition of Proteomedix by Onconetix was valued at approximately $75 million, with 91,885 shares of Common Stock and 2,696,729 shares of Series B Preferred Stock issued as consideration[52]. - The Company purchased assets related to Veru's ENTADFI business for a total possible consideration of $100 million, with an initial payment of $20 million[68]. - The Company entered into a Subscription Agreement for a private placement of $5 million, with each unit consisting of one share of Common Stock and a warrant to purchase additional shares[61]. - Proteomedix entered an exclusive partnership with LabCorp in 2023 for the development and commercialization of Proclarix in the United States, receiving an upfront license fee and future royalty payments[109]. Regulatory and Compliance - The company has received multiple deficiency notices from Nasdaq regarding compliance with listing standards, including failure to maintain a minimum bid price and timely filing of reports[38][40]. - The maximum timeframe for the evaluation of a Marketing Authorization Application (MAA) by the EMA is 210 days, with potential accelerated reviews in urgent cases[147]. - The EMA requires a risk management plan (RMP) for all new MAAs, detailing measures to minimize risks associated with the product[153]. - Compliance with the General Data Protection Regulation (GDPR) is mandatory for processing personal health data in the EU, imposing significant obligations on pharmaceutical companies[137]. - Proteomedix has CE marked Proclarix IVDs under IVDD in 2019 and is now in compliance with IVDR, which includes performance and safety testing[161]. Market and Competitive Landscape - The global market for in vitro diagnostic (IVD) products is projected to reach $101 billion in 2024, with Europe and North America being the largest markets[116]. - In 2022, there were 1,467,854 new cases of prostate cancer and 397,430 related deaths worldwide, highlighting the significant market need for improved diagnostic tools[114]. - The molecular diagnostics field is highly competitive, with many companies developing tests that could pose technological and market access advantages over Proclarix[120]. - Proclarix aims to address the diagnostic "grey zone" where approximately 10% of men have elevated PSA levels, with only 20-40% presenting clinically with cancer[115]. - The use of MRI for prostate cancer diagnosis has increased, but costs range from $415 to $900, indicating a need for more accessible non-invasive diagnostic tests like Proclarix[119]. Operational Challenges - The company has significant debt obligations to Veru, including $10 million due, with forbearance agreements in place until June 30, 2025[204]. - The marketing approval process for Proclarix is lengthy and unpredictable, which may harm the company's business if approval is not obtained[209]. - The company may face significant delays and costs in obtaining foreign regulatory approvals for its products[217]. - Coverage and adequate reimbursement for the product may not be available, impacting its commercial success[219]. - The company has no manufacturing facilities and outsources the production of its IVD kits to a CMO in Germany[186].

Core Points - Onconetix, Inc. received a Staff delisting letter from Nasdaq due to failure to file its Annual Report on Form 10-K for the fiscal year ended December 30, 2024, violating Nasdaq's continued listing requirements [1] - The company is already under review for non-compliance with the Minimum Bid Price Rule, having failed to maintain a minimum bid price of $1.00 per share from November 25, 2024, to January 10, 2025 [3] - Onconetix intends to file the Form 10-K promptly to regain compliance with Nasdaq rules [3] Company Overview - Onconetix is a commercial stage biotechnology company focused on men's health and oncology solutions [4] - The company owns Proclarix®, an in vitro diagnostic test for prostate cancer, and ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia [4]

Core Viewpoint - Onconetix, Inc. and Ocuvex Therapeutics, Inc. have signed a Non-Binding Letter of Intent for a potential business combination, which aims to enhance Onconetix's portfolio beyond oncology and increase shareholder value [1][2]. Company Overview Onconetix, Inc. - Onconetix is a commercial stage biotechnology company focused on men's health and oncology, with products like Proclarix®, an in vitro diagnostic test for prostate cancer, and ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia [4]. Ocuvex Therapeutics, Inc. - Ocuvex is a privately held biopharmaceutical company specializing in ophthalmic therapeutic candidates, formed from the merger of Ocuvex Inc. and Visiox Pharmaceuticals, Inc. in August 2024. Its lead asset, Omlonti®, is an FDA-approved treatment for ocular hypertension and open-angle glaucoma [6]. Transaction Details - The proposed transaction will involve Onconetix acquiring all equity interests of Ocuvex in exchange for newly issued shares of Onconetix, with pre-closing Ocuvex equity holders expected to own approximately 90% of Onconetix post-transaction [2][3]. - The Letter of Intent indicates mutual interest but is subject to due diligence, financing, and regulatory approvals, with no assurance that a definitive agreement will be executed [3].

Core Viewpoint - Onconetix, Inc. has presented new clinical data for its prostate cancer diagnostic test Proclarix® at the 2025 European Association of Urology congress, demonstrating its strong clinical performance in early detection of prostate cancer [1][3]. Company Overview - Onconetix, Inc. is a commercial stage biotechnology company focused on innovative solutions for men's health and oncology, having acquired Proteomedix and its Proclarix® test, which is CE-certified and expected to be marketed in the U.S. as a lab developed test [6]. Product Details - Proclarix® is designed to improve prostate cancer diagnosis by reducing unnecessary biopsies and over-detection of clinically insignificant cancer, addressing the limitations of the traditional PSA test [2][5]. - The test combines in-vitro assays for biomarker detection with a proprietary algorithm to assess the risk of clinically significant prostate cancer, and has been included in both European and American guidelines [5]. Clinical Study Findings - In a study involving 808 patients, Proclarix® showed a negative test result correlating to a 5% or less probability of clinically significant cancer in patients with elevated PSA levels, outperforming other diagnostic tools [3]. - The test demonstrated a sensitivity of 96% and significantly higher specificity compared to %fPSA and the ERSPC risk calculator in a larger cohort of 654 patients [3]. Expert Commentary - The primary investigator of the study emphasized that Proclarix® can safely reduce unnecessary biopsies by ruling out patients with clinically insignificant cancer while minimizing the risk of missing significant cases [4].