Financial Data and Key Metrics Changes - The net loss from continuing operations for fiscal year 2025 was $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year [30] - Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year, primarily due to expenses related to the Phase 2b obesity clinical study for enobosarm [28] - Selling, general and administrative expenses decreased to $19.9 million in fiscal 2025 from $24.6 million in the prior year, mainly due to a reduction in share-based compensation expenses [28] Business Line Data and Key Metrics Changes - The company sold the FC2 Female Condom business for $18 million in cash, resulting in net proceeds of approximately $16.5 million after adjustments, which allowed the company to focus exclusively on drug development [24][26] - The gain on the sale of ENTADFI assets was $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year [28] Market Data and Key Metrics Changes - The company reported a cash balance of $15.8 million as of September 30, 2025, down from $24.9 million as of September 30, 2024 [31] - The company generated cash from investing activities of $25.1 million for fiscal 2025, compared to $0.1 million from investing activities in the prior year [32] Company Strategy and Development Direction - The company is focusing on developing enobosarm as a muscle-preserving agent in combination with GLP-1 receptor agonists to enhance fat loss while preserving lean mass, particularly targeting older patients with obesity [5][19] - The planned Phase 2b PLATEAU clinical trial aims to assess the ability of enobosarm to break through the weight loss plateau in patients with a BMI greater than 35 and age greater than or equal to 65 [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the evolving regulatory landscape for muscle-preservation drugs and the potential for multiple pathways to approval based on clinical outcomes [17][19] - The company highlighted the importance of addressing the weight loss plateau experienced by many patients on GLP-1 receptor agonists, indicating a significant market opportunity [18][50] Other Important Information - The company completed a public offering on October 31, 2025, resulting in net proceeds of approximately $23.4 million, which will support ongoing clinical studies [27][23] - The company reported a loss on the sale of the FC2 Female Condom business of approximately $4.1 million, impacting the financial results for the year [25][31] Q&A Session Summary Question: Will any GLP-1 be allowed in your Phase 2b, or will it be limited to just tirzepatide? - Management indicated that they will choose one GLP-1 receptor agonist to avoid variability in the study, with tirzepatide currently as the placeholder [40] Question: How does the FDA's guidance affect the transition from Phase 2 to Phase 3? - Management clarified that the Phase 2b study is designed to mirror Phase 3 conditions, allowing for a clear understanding of incremental weight loss and functional endpoints [43] Question: What patient population is being targeted in the PLATEAU study? - Management explained that the focus is on patients over 65 with physical limitations, as this group is most in need and will provide informative data for the study [46][49]

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 ...

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 ...

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.) 201 E. Fifth Street, Suite ...

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]

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].

As filed with the Securities and Exchange Commission on June 24, 2024 Registration No. 333-277066 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to 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) Delaware 2834 83-2262816 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 E ...

As filed with the Securities and Exchange Commission on June 24, 2024 Registration No. 333-277066 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to 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) Delaware 2834 83-2262816 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 E ...

As filed with the Securities and Exchange Commission on June 4, 2024 Registration No. 333-277066 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to 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) Delaware 2834 83-2262816 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 E. ...