Onconetix, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Onconetix, Inc. has filed its 2023 Form 10-K, detailing its operations and financial status.</b>

AI Summary

Onconetix, Inc. (ONCO) filed a Annual Report (10-K) with the SEC on April 11, 2024. Onconetix, Inc. (formerly Blue Water Biotech, Inc.) filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company is incorporated in Delaware and its principal executive offices are located at 201 E. Fifth Street, Suite 1900, Cincinnati, OH 45202. Onconetix, Inc. is registered under the standard industrial classification code 2834 for Pharmaceutical Preparations. The company's common stock trades on The Nasdaq Stock Market LLC under the symbol ONCO. Onconetix, Inc. has confirmed it has filed all required reports for the preceding 12 months and has been subject to filing requirements for the past 90 days.

Why It Matters

For investors and stakeholders tracking Onconetix, Inc., this filing contains several important signals. This filing provides a comprehensive overview of Onconetix's business, financial condition, and risk factors for the fiscal year 2023, crucial for investors to assess the company's performance and outlook. The report confirms the company's compliance with SEC filing requirements, indicating a level of operational stability and transparency for stakeholders.

Risk Assessment

Risk Level: low — Onconetix, Inc. shows low risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate, significant negative financial news or operational changes, indicating a low level of immediate risk based solely on this document.

Analyst Insight

Investors should review the full 10-K filing to understand Onconetix's financial performance, strategic initiatives, and identified risks for the fiscal year 2023.

Key Numbers

• 20231231 — Fiscal Year End (The period covered by the annual report.)
• 20240411 — Filing Date (Date the 10-K was filed.)
• 001-41294 — SEC File Number (Commission file number for Onconetix, Inc.)
• 2834 — SIC Code (Standard Industrial Classification for Pharmaceutical Preparations.)

Key Players & Entities

• Onconetix, Inc. (company) — Filer of the 10-K report.
• Blue Water Biotech, Inc. (company) — Former name of Onconetix, Inc.
• Blue Water Vaccines Inc. (company) — Previous former name of Onconetix, Inc.
• The Nasdaq Stock Market LLC (company) — Exchange where ONCO common stock is registered.
• ONCO (company) — Trading symbol for Onconetix, Inc. common stock.

FAQ

Industry Context

Onconetix, Inc. operates within the Pharmaceutical Preparations industry, focusing on the development and commercialization of pharmaceutical products.

Regulatory Implications

The company is subject to the reporting requirements of the Securities Exchange Act of 1934, including the filing of annual reports on Form 10-K.

What Investors Should Do

1. Review the full 10-K for detailed financial statements and management's discussion and analysis.
2. Analyze the risk factors section for potential challenges and uncertainties facing Onconetix.
3. Compare the 2023 results with previous filings to identify trends and changes in performance.

Key Dates

• 2023-12-31: Fiscal Year End — Defines the reporting period for the 10-K.
• 2024-04-11: Filing Date — Indicates when the annual report was submitted to the SEC.

Year-Over-Year Comparison

This is the initial 10-K filing for the fiscal year 2023, following the company's name change from Blue Water Biotech, Inc. on April 24, 2023.

Key Financial Figures

• $0.00001 — ange on which registered Common stock, $0.00001 par value ONCO The Nasdaq Stock Market
• $11.4 million — orking capital deficit of approximately $11.4 million and an accumulated deficit of approxima
• $56.8 million — an accumulated deficit of approximately $56.8 million. We will need to raise additional capit
• $0.166 — ed Stock. Based on the closing price of $0.166 for the Company's stock as of April 5,
• $44.8 million — k would be redeemable for approximately $44.8 million. Until we generate revenue sufficient

Filing Documents

• ea0201701-10k_onconetix.htm (10-K) — 2782KB
• ea020170101ex4-2_onconetix.htm (EX-4.2) — 25KB
• ea020170101ex10-21_onconetix.htm (EX-10.21) — 76KB
• ea020170101ex10-22_onconetix.htm (EX-10.22) — 25KB
• ea020170101ex10-23_onconetix.htm (EX-10.23) — 23KB
• ea020170101ex10-24_onconetix.htm (EX-10.24) — 74KB
• ea020170101ex10-25_onconetix.htm (EX-10.25) — 17KB
• ea020170101ex10-26_onconetix.htm (EX-10.26) — 19KB
• ea020170101ex10-55_onconetix.htm (EX-10.55) — 92KB
• ea020170101ex-19_onconetix.htm (EX-19) — 106KB
• ea020170101ex-21_onconetix.htm (EX-21) — 3KB
• ea020170101ex23-1_onconetix.htm (EX-23.1) — 2KB
• ea020170101ex23-2_onconetix.htm (EX-23.2) — 2KB
• ea020170101ex31-1_onconetix.htm (EX-31.1) — 12KB
• ea020170101ex31-2_onconetix.htm (EX-31.2) — 12KB
• ea020170101ex32-1_onconetix.htm (EX-32.1) — 5KB
• ea020170101ex32-2_onconetix.htm (EX-32.2) — 5KB
• ea020170101ex97_onconetix.htm (EX-97.1) — 18KB
• image_001.jpg (GRAPHIC) — 101KB
• image_002.jpg (GRAPHIC) — 51KB
• image_003.jpg (GRAPHIC) — 48KB
• image_004.jpg (GRAPHIC) — 89KB
• image_005.jpg (GRAPHIC) — 60KB
• ex19_001.jpg (GRAPHIC) — 17KB
• 0001213900-24-032225.txt (&nbsp;) — 13596KB
• bwv-20231231.xsd (EX-101.SCH) — 110KB
• bwv-20231231_cal.xml (EX-101.CAL) — 90KB
• bwv-20231231_def.xml (EX-101.DEF) — 611KB
• bwv-20231231_lab.xml (EX-101.LAB) — 1047KB
• bwv-20231231_pre.xml (EX-101.PRE) — 615KB
• ea0201701-10k_onconetix_htm.xml (XML) — 1112KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 4 2 Item 1B. Unresolved Staff Comments 95 Item 1C. Cybersecurity 95 Item 2.

Properties

Properties 96 Item 3.

Legal Proceedings

Legal Proceedings 96 Item 4. Mine Safety Disclosures 96 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 97 Item 6. [Reserved] 97 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 97 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 111 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 111 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 111 Item 9A.

Controls and Procedures

Controls and Procedures 111 Item 9B. Other Information 113 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 113 PART III Item 10. Directors, Executive Officers and Corporate Governance 114 Item 11.

Executive Compensation

Executive Compensation 120 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 125 Item 13. Certain Relationships and Related Transactions, and Director Independence 133 Item 14. Principal Accountant Fees and Services 134 PART IV Item 15. Exhibits and Financial Statement Schedules 136 Item 16. Form 10-K Summary

Signatures

Signatures 140 i CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this "Report") contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking of Financial Condition and Results of Operations," and "Business," but are also contained elsewhere in this Report. In some cases, you can identify

forward-looking statements by the words "may," "might," "will," "could," "would,"

forward-looking statements by the words "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future, although not all forward-looking statements contain these words. These statements relate to future events or our future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity, performance, or achievement to differ materially from those expressed or implied by these forward-looking statements. These forward-looking our projected financial position and estimated cash burn rate; our estimates regarding expenses, future revenues and capital requirements; our ability to continue as a going concern; our need to raise substantial additional capital to fund our operations; our ability to commercialize or monetize ENTADFI and Proclarix and integrate the assets and commercial operations acquired in the share exchange with Proteomedix AG ("Proteomedix"); the successful development of our commercialization capabilities, including sales and marketing capabilities. our ability to maintain the necessary regulatory approvals to market and commercialize our products; the results of market research conducted by us or others; our ability to obtain and maintain intellectual property protection for our current products; our ability to protect our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual property rights; t he possibility that a third party may claim we or our third-party licensors have infringed, misappropriated, or otherwise violated their intellectual property rights and

Business

Item 1. Business Company Overview We are a commercial stage biotechnology company focused on the research, development, and commercialization of innovative solutions for men's health and oncology. Through our recent acquisition of Proteomedix, we own Proclarix, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union under the In Vitro Diagnostic Regulation ("IVDR"), which we anticipate will be marketed in the U.S. as a lab developed test through our license agreement with LabCorp. We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of BPH, a disorder of the prostate. Proclarix is an easy-to-use next generation protein-based blood test that can be done with the same sample as a patient's regular Prostate-Specific Antigen ("PSA") test. The PSA test is a well-established prostate specific marker that measures the concentration of PSA molecules in a blood sample. A high level of PSA can be a sign of prostate cancer. However, PSA levels can also be elevated for many other reasons including infections, prostate stimulation, vigorous exercise or even certain medications. PSA results can be confusing for many patients and even physicians. It is estimated over 50% of biopsies with elevated PSA are negative or clinically insignificant resulting in an overdiagnosis and overtreatment that impacts the physician's routine, our healthcare system, and the quality of patients' lives. Proclarix helps doctors and patients with unclear PSA test results through the use of our proprietary Proclarix Risk Score which delivers clear and immediate diagnostic support for further treatment decisions. No additional intervention is required, and results are available quickly. Local diagnostic laboratories can integrate this multiparametric test into their current workflow because Proclarix assays use the enzyme-linked immunosorbent assay (ELISA) standard, which

View Full Filing

View this 10-K filing on SEC EDGAR