Realbotix Humanoid Robot — Ericsson’s First Enterprise Robotics Client — Featured as Live Connected Endpoint in Pre-Standard 6G Over-the-Air Trial at Ericsson’s U.S. Headquarters; Onconetix Has Entered into a Definitive Agreement to Acquire Realbotix CINCINNATI, Ohio, March 25, 2026 (GLOBE NEWSWIRE) -- Onconetix, Inc. (Nasdaq: ONCO) (“Onconetix” or the “Company”) wishes to draw its shareholders’ attention to a development reported by Realbotix Corp. (TSX-V: XBOT; Frankfurt: 76M0.F; OTC: XBOTF) (“Realbotix C ...

CINCINNATI, Ohio, March 23, 2026 (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 its Board of Directors (the “Board of Directors” or “Board”) has approved a 1-for-5 reverse stock split of its outstanding shares of common stock, to be effective as of 12:01 a.m. Eastern Time on March 25, 2026. On Febr ...

Acquisition and Corporate Structure - The company acquired Proteomedix on December 15, 2023, gaining Proclarix, an in vitro diagnostic test for prostate cancer approved for sale in the EU[23]. - Onconetix acquired Proteomedix for approximately $75 million, issuing 1,081 shares of Common Stock and 2,696,729 shares of Series B Preferred Stock convertible into 79,315 shares of Common Stock[67]. - Following the acquisition, Proteomedix became a wholly owned subsidiary of Onconetix, with the Sellers owning approximately 87.2% of Onconetix's outstanding equity interests[70]. - Onconetix's stockholders prior to the acquisition retained approximately 5.3% of the outstanding equity interests post-transaction[70]. - The Share Exchange Agreement with Realbotix Corp. was signed on February 11, 2026, involving the acquisition of Realbotix Interests in exchange for newly issued shares of Common Stock[34]. Financial Performance and Position - As of December 31, 2025, the company had cash of approximately $5.2 million, a working capital deficit of approximately $3.1 million, and an accumulated deficit of approximately $131.2 million[31]. - The company has incurred net losses since inception and expects to continue doing so in the foreseeable future, with a cash balance insufficient to fund operations for one year from the issuance of the financial statements[31]. - The net loss for the year ended December 31, 2025, was $14.0 million, compared to a net loss of $58.7 million for the year ended December 31, 2024[214]. - The Company expects to incur substantial and increasing operating losses over the next several years, raising doubts about its ability to continue as a going concern[215]. - Total current liabilities as of December 31, 2025, were approximately $9.1 million, including accounts payable of approximately $1.8 million[221]. Product Development and Commercialization - Proclarix is expected to generate growing revenues starting in 2026, which will help offset some expenses related to its commercialization[27]. - Proclarix, the company's lead product, is an in vitro diagnostic test for prostate cancer, approved for sale in the EU and designed to reduce unnecessary biopsies[96]. - The company aims to enhance Proclarix by integrating additional biomarkers and imaging data into its clinical decision support system[96]. - Proclarix generated revenues of $23,091 in 2025, while Proteomedix had total sales of $67,380 prior to its acquisition by Onconetix in 2023[97]. - Proclarix has demonstrated a high sensitivity of 90% and a negative predictive value of 95% for clinically significant prostate cancer, potentially reducing unnecessary biopsies by approximately 43% compared to clinical comparators[108]. Regulatory Compliance and Market Access - Regulatory compliance is critical for marketing Proclarix, with varying requirements across countries, including the EU and the U.S.[149]. - The FDA and other regulatory authorities impose extensive regulations on the development and marketing of diagnostic products, impacting timelines and processes[148]. - The new regulatory framework for medical devices in the EU, including the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), was implemented to address significant gaps in market surveillance and compliance[172]. - Proteomedix AG has successfully transitioned its Proclarix devices to comply with the IVDR, making them one of the first IVDs under the new EU regime[178]. - The IVDR provides a systematic post-market surveillance data collection from Proclarix devices, which supports the clinical evidence of their validity[178]. Funding and Capital Structure - The company entered into Series D and Series E PIPE financings in September and October 2025, respectively, to support near-term operations[31]. - The company will need to raise additional capital to fund ongoing operations and product development, raising substantial doubt about its ability to continue as a going concern[32]. - The company entered into a Subscription Agreement for a private placement of $5.0 million, with each unit comprising one share of Common Stock and a warrant to purchase 0.3 shares at an exercise price of $3.40 per share[76]. - The Series C Preferred Stock issuance resulted in net cash proceeds of $1.9 million from the sale of 3,499 shares to institutional investors[206]. - The Company sold 16,099 shares of Series D convertible preferred stock for approximately $12.9 million, resulting in net cash proceeds of $9.3 million[210]. Market and Competitive Landscape - The global in vitro diagnostic (IVD) market is projected to reach $109 billion by 2025, with Europe and North America being the largest markets[130]. - The molecular diagnostics field is highly competitive, with many companies having greater financial and market resources, posing challenges for Proclarix[135]. - Proclarix's competitive positioning is complemented by the growing adoption of MRI-based diagnosis, which requires supportive diagnostic tools for effective patient selection[142]. - Approximately 60% of men undergoing prostate biopsies do not have clinically significant cancer, highlighting the need for improved diagnostic tools like Proclarix[132]. Employee and Operational Aspects - As of March 10, 2026, Proteomedix employed 2 full-time and 6 subcontracted employees, maintaining good relations with its workforce[201]. - The company has a monthly lease of $2,000 for its office and lab space in Switzerland, renewed for a two-year term[203]. - The company has recorded common stock of $2 and additional paid-in capital of $995,036 related to the issuance of 241,514 shares due to the Make-Whole Provision[82]. Partnerships and Collaborations - In the United States, Proteomedix entered an exclusive partnership with LabCorp in 2023 for the development and commercialization of Proclarix, receiving an upfront license fee and future royalty payments[123]. - A licensing agreement with Immunovia in September 2025 includes payments of $300,000 each and a 3% royalty on net sales of PancreaSure from January 1, 2026, through December 31, 2032[192]. - In 2022, Proteomedix partnered with Immunovia AB to enhance research and development productivity, accelerating the roll-out of the IMMray PanCan-d test[191].

Core Viewpoint - The company has experienced a poor start to the year in terms of share price despite positive developments such as success at CES and securing Ericsson as a key client [2]. Group 1: Company Developments - The company is making substantial progress on its audit and is optimistic about meeting the deadline later this month [3]. - The previous CFO left unexpectedly, necessitating a restart of the accounting process with the new CFO, Scott Meyers, who is viewed positively by the company [3]. - The relationship with auditors is reported to be excellent, with no issues found, although the audit process started later than initially planned [4].

Core Viewpoint - Onconetix, Inc. is acquiring Realbotix LLC in an all-stock transaction, aiming to enhance shareholder value through the integration of Realbotix's advanced humanoid robotics technology [1][4]. Company Overview - Onconetix, Inc. is a biotechnology company focused on oncology solutions, including the Proclarix® diagnostic test for prostate cancer [8]. - Realbotix LLC specializes in AI-powered humanoid robotics, designed for customer-facing roles across various industries such as healthcare, education, hospitality, and entertainment [2][9]. Transaction Details - The share exchange agreement allows Onconetix to acquire 100% of Realbotix's equity interests, with Realbotix Parent expected to hold between 75% and 90% of the combined company's shares post-transaction [4][5]. - The transaction has been unanimously approved by the boards of both companies and is subject to customary closing conditions, including shareholder approval and regulatory clearances [5]. Technological Advancements - Realbotix is recognized for its patented technologies that enable lifelike expressions and social interactions, allowing its robots to operate autonomously without human teleoperation [3]. - The robots are equipped with advanced vision systems capable of interpreting emotional visual cues and situations, enhancing their functionality in public venues [3]. Strategic Importance - The merger is viewed as a strategic move to unlock significant value for shareholders and to position the combined entity for future growth in the humanoid robotics market [4]. - Andrew J. Oakley, Chairman of Onconetix, expressed excitement about the potential to change the company's strategic direction through this acquisition [3].

Financial Performance - Total revenue for Q3 2025 was $303,651, a decrease of 25.4% compared to $406,859 in Q3 2024[16] - Gross profit for Q3 2025 was $268,894, significantly higher than $105,414 in Q3 2024, reflecting improved cost management[16] - The net loss for Q3 2025 was $8,783,702, compared to a net loss of $3,827,405 in Q3 2024, representing an increase in losses of 129.3%[16] - The company reported a gross profit margin of 88.5% in Q3 2025, compared to 25.9% in Q3 2024, indicating improved profitability[16] - For the nine months ended September 30, 2025, the company reported a net loss of $19.7 million, an improvement from a net loss of $29.3 million for the same period in 2024, representing a 32.5% reduction in losses[24] - The company used approximately $6.6 million in cash for operating activities during the nine months ended September 30, 2025, compared to $9.6 million in the same period of 2024, indicating a 31.3% decrease in cash used[24] Assets and Liabilities - Total assets decreased to $19,678,868 as of September 30, 2025, down from $28,181,563 at December 31, 2024, a decline of 30.3%[14] - Current liabilities decreased to $16,303,023 as of September 30, 2025, from $18,290,129 at December 31, 2024, a reduction of 10.8%[14] - The accumulated deficit increased to $136,884,245 as of September 30, 2025, compared to $115,683,621 at December 31, 2024, an increase of 18.3%[14] - The total stockholders' equity decreased to $3,374,121 as of September 30, 2025, down from $8,542,627 at December 31, 2024, a decline of 60.5%[14] Stock and Equity - The balance of common stock increased to $119,563,951, indicating ongoing capital activities[19] - The company had a total of 64,236,085 shares of common stock outstanding as of the latest reporting date[19] - The balance of preferred stock as of September 30, 2025, was $1,560,820, with total stockholders' equity at $141,431,240[22] - The company raised approximately $12.9 million from the Series D PIPE Financing, resulting in net cash proceeds of $9.3 million, and issued 16,099 shares of Series D Preferred Stock[157] Revenue Sources - The company generated total revenue of $303,651 during the three months ended September 30, 2025, with 100% of other revenue coming from the European Union[59] - For the nine months ended September 30, 2025, total revenue was $511,775, with 93% of product sales originating from the European Union[61] - The Company recognized a license revenue of $300,000 from Immunovia AB in Q3 2025, with an additional payment of $300,000 due by March 31, 2026[84] Financing and Debt - 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[115] - The Company recorded approximately $0.3 million and $0.8 million of interest expense for the three and nine months ended September 30, 2025, respectively[111] - The Company recognized a loss on extinguishment of notes payable of $1,867,908 for the three and nine months ended September 30, 2025[125] Impairments and Adjustments - The company recorded full impairments of intangible assets acquired from the acquisitions of Proteomedix and ENTADFI during the year ended December 31, 2024[50] - The Company recorded an intangible asset impairment charge of approximately $3.5 million during the nine months ended September 30, 2024, due to competitive pressures[71] - Goodwill balance as of September 30, 2025, was $18,180,299, reflecting an impairment loss of approximately $11.5 million for the nine months ended September 30, 2025[72][73] Operational Challenges - The company incurred substantial operating losses since inception and expects to continue incurring significant losses for the foreseeable future[37] - The company has no committed sources of financing and faces uncertainty regarding the availability of additional funding on favorable terms[40] - The company abandoned the commercialization of ENTADFI and fully impaired its assets as of June 30, 2024, due to insufficient resources and cash runway[30] Agreements and Legal Matters - The Company entered into an Amended and Restated Forbearance Agreement with Veru, extending the due date for the April and September 2024 Veru Notes until June 30, 2025[94] - The Company agreed to make required payments during the April 2024 Forbearance Period, including $50,000 of principal and 15% of monthly cash receipts from Proteomedix and Proclarix sales[96] - The company terminated the Merger Agreement with Ocuvex and paid a Termination Payment of $302,343.55[204]

As filed with the Securities and Exchange Commission on November 4, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Onconetix, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 83-2262816 (I.R.S. Employer Identification No.) 201 E. Fifth Street, Suite ...

As filed with the Securities and Exchange Commission on November 4, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Onconetix, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 83-2262816 (I.R.S. Employer Identification No.) 201 E. Fifth Street, Suite ...

Group 1 - Onco-Innovations Limited has appointed Mr. Jared Rushton to its Board of Directors, effective immediately [1]

As filed with the Securities and Exchange Commission on October 15, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Onconetix, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 2834 83-2262816 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) If any of the securities be ...