CINCINNATI, Ohio, June 16, 2025 (GLOBE NEWSWIRE) -- Onconetix, Inc. (Nasdaq: ONCO) (“Onconetix” or the “Company”), a commercial-stage biotechnology company focused on the research, development, and commercialization of innovative solutions for men’s health and oncology, today reported that on June 11, 2025, the Company received a decision from the Nasdaq Hearings Panel granting the Company’s request for continued listing on The Nasdaq Stock Market, subject to the Company demonstrating compliance with the Na ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41294 Onconetix, Inc. (Exact name of registrant as specified in its charter) Delaware 83-2262816 (State or other jurisdiction o ...

CINCINNATI, Ohio, June 11, 2025 (GLOBE NEWSWIRE) -- Onconetix, Inc. (NASDAQ: ONCO) (“Onconetix” or the “Company”), a commercial-stage biotechnology company focused on the research, development, and commercialization of innovative solutions for men’s health and oncology, today announced that the Company’s stockholders have approved a proposal to effect a reverse split, which was voted on at the Company’s 2025 special meeting of stockholders (the “Special Meeting”) held on May 30, 2025, and that its Board of ...

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].

Core Insights - Onconetix, Inc. announced the acceptance of an abstract for presentation at the 2025 European Association of Urology (EAU) congress, focusing on the clinical performance of Proclarix in ruling out clinically insignificant or no prostate cancer [1][2] Company Overview - Onconetix, formerly known as Blue Water Biotech, is a cancer diagnostics company dedicated to the research, development, and commercialization of innovative oncology solutions [1][5] - The company has recently acquired Proteomedix, which developed Proclarix, an in vitro diagnostic test for prostate cancer, approved for sale in the EU under the In Vitro Diagnostic Regulation (IVDR) [5] Product Details - Proclarix is a CE-certified blood test indicated for prostate cancer diagnosis in patients with normal digital rectal exams, enlarged prostate volume, and elevated PSA levels between 2-10 ng/ml [4] - The test combines in-vitro assays for quantitative detection of biomarkers with a proprietary algorithm to assess the risk of clinically significant prostate cancer [4] - Proclarix has shown reliability in multiple clinical studies as an indicator of clinically significant prostate cancer and is included in both European and American guidelines [4] Presentation Information - The presentation titled "Clinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort" will take place on March 23, 2025, at the EAU congress [2][3] - The study involved over 800 patients from Lillebaelt Hospital - University Hospital of Southern Denmark [2]

Core Points - Onconetix, Inc. received a notification from Nasdaq regarding its failure to file the Quarterly Report on Form 10-Q for the period ended September 30, 2024, which is a violation of Nasdaq's continued listing requirements [1] - The Company subsequently filed the Form 10-Q with the Securities and Exchange Commission on December 10, 2024, in compliance with Nasdaq Listing Rule 5810(b) [2] - Onconetix is a biotechnology company focused on men's health and oncology, owning Proclarix®, an in vitro diagnostic test for prostate cancer, and ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia [3]

Revenue and Profitability - Revenue for the three months ended September 30, 2024, was $406,859, compared to $0 for the same period in 2023, representing a significant increase[22]. - Gross profit for the nine months ended September 30, 2024, was $395,130, with total operating expenses of $27,738,007, leading to a loss from operations of $27,342,877[22]. - The net loss for the three months ended September 30, 2024, was $3,827,405, compared to a net loss of $5,346,908 for the same period in 2023, indicating an improvement[22]. - The net loss for the nine months ended September 30, 2023, was $(5,346,908), compared to a net loss of $(34,435,322) for the same period in the previous year[24]. - The company reported a net loss of $29,252,681 for the nine months ended September 30, 2024, compared to a net loss of $15,058,822 for the same period in 2023[28]. Assets and Liabilities - Total current assets decreased to $1,047,939 as of September 30, 2024, from $5,838,271 as of December 31, 2023[19]. - Total liabilities decreased slightly to $20,896,798 as of September 30, 2024, from $21,877,471 as of December 31, 2023[19]. - The company reported an accumulated deficit of $86,038,875 as of September 30, 2024, compared to $56,786,194 as of December 31, 2023[19]. - The company had cash of approximately $341,495, down from $7,653,975 at the end of the previous period[28]. - The company has a working capital deficit of approximately $16.3 million and an accumulated deficit of approximately $86.0 million as of September 30, 2024[41]. Stockholder Equity and Shares - Total stockholders' equity increased to $41,022,620 as of September 30, 2024, from $1,404,476 as of December 31, 2023[19]. - The weighted average number of common shares outstanding for the three months ended September 30, 2024, was 1,306,146, compared to 438,039 for the same period in 2023[22]. - The company had a total common stock amount of $119,563,869 as of September 30, 2024, reflecting an increase from previous periods[24]. - As of September 30, 2024, the Company had 8,326,281 shares of common stock issued, a significant increase from 571,033 shares as of December 31, 2023[195]. Expenses and Cash Flow - Research and development expenses for the three months ended September 30, 2024, were $109,365, down from $219,238 for the same period in 2023[22]. - The company incurred approximately $9.6 million in cash used for operating activities during the nine months ended September 30, 2024[41]. - The company recorded a net cash used in investing activities of $24,597 for the nine months ended September 30, 2024, compared to $9,864,613 for the same period in 2023[28]. Acquisitions and Impairments - On December 15, 2023, the company acquired 100% of Proteomedix AG, enhancing its capabilities in prostate cancer diagnosis[32]. - The company recorded an impairment charge of approximately $0.4 million on ENTADFI inventory during the quarter ended June 30, 2024[72]. - Goodwill decreased to $38.9 million as of September 30, 2024, from $55.7 million as of December 31, 2023, reflecting a cumulative impairment charge of $15.5 million for the nine months ended September 30, 2024[92][90]. - The Company recorded a loss on impairment for the $3.5 million deposit related to the WraSer acquisition due to the bankruptcy filing of WraSer[121]. Financing and Debt - The company entered into an Equity Financing Line of Credit (ELOC) on October 2, 2024, to address its cash flow needs[41]. - The Company executed three non-interest-bearing notes payable totaling $14.0 million, with maturity dates ranging from September 30, 2023, to September 30, 2024[152]. - The Company entered into a forbearance agreement with Veru, extending the due date for a $5.0 million note payable to March 31, 2025, with interest accruing at 10% per annum[155]. - The Company issued a non-convertible debenture of $5.0 million to a related party, with an interest rate of 4.0% per annum, originally due by June 30, 2024[171]. Strategic Initiatives - The company halted its commercialization of ENTADFI in early 2024 and is exploring strategic alternatives, including a potential sale of the ENTADFI assets[34]. - The company is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets[34]. - The Company is in the process of finalizing the initial accounting for the business combination, with adjustments to provisional amounts expected to be completed by December 15, 2024[129]. Going Concern and Future Outlook - There is substantial doubt about the company's ability to continue as a going concern for one year from the issuance of the financial statements due to historical and expected operating losses[43]. - The company plans to secure additional funding through equity or debt financings, but current available funds under the ELOC are insufficient to sustain operations[42]. - The Company is obligated to pay up to an additional $80.0 million in milestone payments based on net sales of ENTADFI, with specific payments of $10.0 million at $100.0 million in sales, $20.0 million at $200.0 million, and $50.0 million at $500.0 million[98].