Financial Performance - For the three months ended September 30, 2025, ONCONETIX, INC. reported revenue of $303,651, a decrease of 25.4% compared to $406,859 for the same period in 2024[16] - The gross profit for the three months ended September 30, 2025, was $268,894, significantly higher than the gross profit of $105,414 in the same period of 2024[16] - The net loss for the three months ended September 30, 2025, was $8,783,702, compared to a net loss of $3,827,405 for the same period in 2024, reflecting an increase in losses[16] - For the nine months ended September 30, 2025, the net loss was $19.7 million, a decrease from a net loss of $29.3 million for the same period in 2024, representing a 32.5% improvement[24] - The company reported a net cash used in operating activities of $6.6 million for the nine months ended September 30, 2025, compared to $9.6 million for the same period in 2024, indicating a 31.5% reduction in cash outflow[24] Assets and Liabilities - Total current assets increased to $1,302,026 as of September 30, 2025, from $950,267 as of December 31, 2024, representing a growth of 37%[14] - Total liabilities decreased to $16,303,023 as of September 30, 2025, from $18,571,008 as of December 31, 2024, indicating a reduction of approximately 12.2%[14] - The total stockholders' equity decreased to $3,374,121 as of September 30, 2025, from $8,542,627 as of December 31, 2024, reflecting a decline of 60.5%[14] - The accumulated deficit increased to $136,884,245 as of September 30, 2025, from $115,683,621 as of December 31, 2024, showing a rise of 18.3%[14] Stock and Equity Transactions - The weighted average number of common shares outstanding for the three months ended September 30, 2025, was 1,405,469, compared to 15,366 for the same period in 2024[16] - The company issued 765,029 shares in connection with the exercise of preferred investment options[19] - The Company raised approximately $12.9 million from the Series D PIPE Financing, resulting in net cash proceeds of $9.3 million[157] - The Series D Preferred Stock was classified as permanent equity and recorded at par value, while the Series D Warrants were classified as liability-classified instruments[160] Impairments and Losses - The company incurred a loss on impairment of goodwill amounting to $11.5 million for the nine months ended September 30, 2025, compared to $15.5 million in the prior year[24] - 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] - The Company recognized a loss on extinguishment of $5,384,719 related to the debt extinguishment transaction during the three and nine months ended September 30, 2025[159] Revenue Sources - The company generated 100% of its other revenue from the European Union during the three months ended September 30, 2025[59] - For the nine months ended September 30, 2025, product sales accounted for 93% of total revenue, with the remaining 7% from the European Union[59] - Customer A accounted for 100% of development services revenue for the three months ended September 30, 2025[61] Financing and Debt - The Company entered into an ELOC Purchase Agreement allowing for the sale of up to $25 million in common stock, with 30% of gross proceeds allocated to redeem Series C Preferred Stock[169] - The Company issued a non-convertible debenture of $5.0 million to a related party with an interest rate of 4.0% per annum[115] - The Company recognized approximately $0.3 million and $0.8 million of interest expense for the three and nine months ended September 30, 2025, respectively[111] Future Outlook and Concerns - Management plans to generate product revenue from Proclarix sales, which is still subject to further development and commercialization[40] - The company continues to face substantial doubt about its ability to continue as a going concern within one year from the issuance of the financial statements[41]

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 June 30, 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 ...

Financial Performance - Total revenue for Q1 2025 was $101,630, a decrease of 85.5% compared to $700,433 in Q1 2024[17] - Gross profit for Q1 2025 was $45,832, down 75.7% from $189,000 in Q1 2024[17] - Net loss for Q1 2025 was $8,545,885, compared to a net loss of $11,118,572 in Q1 2024, representing a 23.1% improvement[17] - Operating expenses for Q1 2025 totaled $12,616,661, an increase from $11,270,990 in Q1 2024[17] - The company reported a basic and diluted net loss per share of $0.53 for Q1 2025, compared to $20.08 for Q1 2024[17] - Revenue for the three months ended March 31, 2025, was approximately $0.1 million, a decrease from $0.7 million for the same period in 2024[54] - Product sales accounted for 93% of total revenue in the three months ended March 31, 2025, while development services accounted for 100% of revenue[54] Assets and Liabilities - Total current assets increased to $2,420,589 as of March 31, 2025, from $950,267 as of December 31, 2024, a growth of 154.5%[15] - Total liabilities decreased to $14,258,469 as of March 31, 2025, down 23.5% from $18,571,008 as of December 31, 2024[15] - Goodwill decreased significantly to $16,209,509 as of March 31, 2025, from $27,048,973 as of December 31, 2024, a reduction of 40.2%[15] - Cash and cash equivalents increased to $1,577,193 as of March 31, 2025, from $646,500 as of December 31, 2024, a rise of 144.5%[15] - Total stockholders' equity decreased to $3,992,793 as of March 31, 2025, from $8,542,627 as of December 31, 2024, a decline of 53.3%[15] - As of March 31, 2025, Onconetix had cash of approximately $1.6 million and a working capital deficit of approximately $11.6 million, with an accumulated deficit of approximately $125.4 million[35] Impairment and Expenses - The company incurred a loss on impairment of goodwill amounting to $10,918,000 for the three months ended March 31, 2025, compared to $5,192,000 in the prior year, indicating a 110% increase in impairment losses[23] - The company recognized goodwill impairment losses of approximately $10.9 million for the three months ended March 31, 2025, compared to $5.2 million for the same period in 2024[65] - The company recorded full impairments of intangible assets acquired from the acquisitions of Proteomedix and ENTADFI, resulting in a zero balance as of March 31, 2025[60] - The company incurred net periodic benefit costs of $16,134 for the three months ended March 31, 2025, compared to a net periodic benefit cost of $(6,733) for the same period in 2024[169] Capital Structure and Financing - The company redeemed Series C preferred stock amounting to approximately $1.71 million in 2025, indicating ongoing efforts to manage its capital structure[35] - The company has two non-interest-bearing notes payable of $5.0 million each, with maturity dates of April 19, 2024, and September 30, 2024[75] - A non-convertible debenture of $5.0 million was issued to a related party with an interest rate of 4.0% per annum, originally payable by June 30, 2024[91] - The maturity date of the related party debenture was extended to October 31, 2024, with no other terms modified[92] - The Company issued a promissory note to Keystone Capital Partners, LLC with an aggregate principal amount of $117,647.06, due by November 12, 2025[100] - The Company raised $2,000,000 from the sale of 3,499 Series C Preferred Stock and warrants to purchase 591,856 shares of common stock on October 2, 2024[121] - The Company received approximately $4.8 million under the Equity Line of Credit (ELOC) during the three months ended March 31, 2025[125] Business Operations and Strategy - Onconetix acquired Proteomedix AG on December 15, 2023, enhancing its capabilities in prostate cancer diagnosis with the Proclarix diagnostic product[26] - The company has abandoned the commercialization of ENTADFI due to insufficient resources and is exploring options for the sale of ENTADFI assets[28] - Management plans to generate product revenue from Proclarix and seeks additional funding through equity or debt financing to support ongoing operations[36] - The company is focusing on the commercialization of Proclarix, an in vitro diagnostic test for prostate cancer, which is expected to generate revenue by 2027[185][192] - The company has no products approved for sale aside from Proclarix and has not generated any revenue from product sales to date[193] Corporate Governance and Management - The company is currently searching for a permanent Chief Executive Officer and Chief Financial Officer[187] - The Company has entered into a potential business combination with Ocuvex Therapeutics, Inc., which would result in Ocuvex equity holders owning approximately 90% of the Company post-transaction[177] Tax and Regulatory Matters - The Company recorded an income tax benefit of approximately $127,000 for the three months ended March 31, 2024, yielding an effective tax rate of 21.3% for Proteomedix[161] - The Company has recorded a full valuation allowance against its U.S. deferred tax assets due to uncertainty around utilizing these tax attributes[162]

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 anticipated based on various operational activities[28]. - The company generated negative operating cash flows of $10.5 million for the year ended December 31, 2024[198]. - 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 has no assurance of generating sufficient revenue to support self-sustaining cash flows, raising substantial doubt about its ability to continue as a going concern[30]. - The company has abandoned the commercialization of ENTADFI due to cash constraints and is seeking to sell or transact the ENTADFI assets[205]. - The company plans to seek funding through a combination of equity offerings, debt financing, or other capital sources, which may not be available on favorable terms[207]. Product Development and Commercialization - Proclarix is an in vitro diagnostic test for prostate cancer, approved for sale in the European Union, and is expected to be marketed in the U.S. as a lab-developed test[23]. - Proclarix aims to address the issue of overdiagnosis in prostate cancer, which can lead to unnecessary biopsies and increased healthcare costs[48]. - Proclarix generated revenues of $86,957 in 2024, while prior to its acquisition by Onconetix, Proteomedix had revenues of $67,380 from Proclarix sales[49]. - The marketing approval process for Proclarix is lengthy and unpredictable, and the company cannot commercialize Proclarix in the U.S. without obtaining approval from CMS and state agencies[210]. - The company’s ability to commercialize its product depends on obtaining adequate reimbursement from government health programs and private insurers[219]. - Coverage and reimbursement for newly approved products may be delayed and may not cover the costs of manufacture, sale, and distribution[220]. Regulatory Compliance - The company 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][41]. - 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]. - Regulatory approval processes vary significantly between countries, impacting the timeline and requirements for marketing products internationally[139]. - The IVDR introduces significant changes for IVD manufacturers, including a new risk-based classification system and stricter regulatory responsibilities throughout the supply chain[159]. Partnerships and Acquisitions - The company signed a Non-Binding Letter of Intent with Ocuvex Therapeutics for a potential business combination, where Ocuvex equity holders would own approximately 90% of the combined company[33]. - Proteomedix entered an exclusive partnership with LabCorp in 2023 for the commercialization of Proclarix in the United States, receiving an upfront license fee and future royalty payments[109]. - The company entered into an asset purchase agreement to acquire six FDA-approved pharmaceutical assets for a total of $8.5 million in cash and 1 million shares of common stock[74][75]. - The partnership with Immunovia AB aims to leverage Proteomedix's R&D capabilities to accelerate the roll-out of their proprietary IMMray PanCan-d test[179]. - Proteomedix has entered into a research and development partnership with New Horizon Health Limited to enhance cancer patient management[178]. Market Opportunity and Competitive Landscape - In 2022, there were 1,467,854 new cases of prostate cancer and 397,430 related deaths worldwide, highlighting the significant market opportunity for Proclarix[114]. - The worldwide market for in vitro diagnostic (IVD) products is projected to be valued at $101 billion in 2024, with Europe and North America being the largest markets[116]. - The molecular diagnostics field is highly competitive, with many companies developing tests for prostate cancer, but Proclarix offers advantages such as being blood-based and minimally invasive[120]. - Proclarix is positioned as a complementary tool to MRI-based diagnosis, supporting the decision-making process for patients undergoing MRI and targeted biopsy[127]. Product Features and Efficacy - Proclarix is designed to indicate the risk of clinically significant prostate cancer using a risk score derived from a clinical decision support system[86]. - Proclarix has demonstrated a 90% sensitivity and a 95% negative predictive value for clinically significant prostate cancer in clinical studies[95]. - The validation study showed that Proclarix could reduce unnecessary biopsies by approximately 43% compared to clinical comparators[95]. - EAU guidelines recommend using Proclarix as an additional biomarker test to reduce negative biopsies in men with PSA levels between 3–10 ng/mL[99]. - Proclarix was included in the 2023 AUA/SUO clinical practice guideline, emphasizing its role in the early detection of clinically significant prostate cancer (GG2+) and improving biopsy safety[100]. Financial Instruments and Debt - The Company issued a non-convertible debenture to the PMX Investor for $5 million, with an interest rate of 4% per annum[62]. - The Altos Debenture was amended to extend the maturity date to October 31, 2024, and the outstanding debt was settled through the issuance of units[64]. - Following the PMX Transaction, sellers owned approximately 87.2% of Onconetix's outstanding equity interests[55]. - The PMX Transaction involved Onconetix issuing shares valued at approximately $75 million as consideration for the acquisition of Proteomedix[52]. - The fair value of the shares issued in the PMX Transaction was approximately $65.1 million, based on the closing price of $9.528 per share[53].

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[22]. - The net loss for the nine months ended September 30, 2024, was $5,346,908, compared to a net loss of $14,306,704 for the same period in the previous year[24]. - For the nine months ended September 30, 2024, the company reported a net loss of $29,252,681 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 total stockholders' equity increased to $41,022,620 as of September 30, 2024, from $1,404,476 as of December 31, 2023[19]. - As of September 30, 2024, 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]. Stock and Equity - 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 of 8,326,281 common stock shares outstanding as of September 30, 2024[24]. - Stock-based compensation for the nine months ended September 30, 2024, amounted to $272,781[24]. - The total additional paid-in capital as of September 30, 2024, was $119,563,869[24]. - The Company issued 2,696,729 shares of Series B Convertible Preferred Stock, convertible into approximately 6,741,820 shares of common stock upon Stockholder Approval obtained on September 5, 2024[192]. - The Company has authorized the issuance of up to 250,000,000 shares of common stock and 10,000,000 shares of preferred stock as of September 30, 2024[185]. Impairments and Adjustments - The company incurred a total of $15,453,000 in goodwill impairment and $3,530,716 in impairment of ENTADFI assets during the current reporting period[28]. - The company recorded approximately $1.5 million in acquisition-related costs during 2023, which were expensed[142]. - The Company recorded an impairment charge of approximately $14.7 million on the ENTADFI asset group during the fourth quarter of 2023, along with a $1.2 million impairment on acquired inventory[109]. - The company recognized a cumulative impairment charge of $15.5 million related to goodwill for the nine months ended September 30, 2024, with a balance of $38.9 million as of September 30, 2024[90][92]. Acquisitions and Strategic Moves - On December 15, 2023, the company acquired 100% of Proteomedix AG, enhancing its capabilities in prostate cancer diagnosis[32]. - The company has paused the commercialization of ENTADFI and is exploring strategic alternatives, including a potential sale of the ENTADFI assets[34]. - The Company acquired ENTADFI for a total possible consideration of $100 million, with initial consideration of $20 million paid upon closing and additional payments scheduled for 2024[96][97]. - The Company entered into an asset purchase agreement with WraSer for $3.5 million in cash at signing and $4.5 million in cash at closing, along with 25,000 shares of common stock and a $500,000 payment one year post-closing[113]. Financing and Cash Flow - The company entered into an Equity Financing Line of Credit (ELOC) on October 2, 2024, to address its cash flow needs[41]. - The company recorded a net cash used in investing activities of $24,597 for the current period, significantly lower than $9,864,613 in the previous period[28]. - Management plans to secure additional funding through equity or debt financings, but current ELOC funds are insufficient to sustain operations[42]. - 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]. Future Outlook and Risks - The company has significant uncertainty regarding its ability to sustain operations due to historical and expected operating losses, with no commitments for further financing[43]. - The company may need to curtail future clinical trials and product development if additional capital is not secured[42]. - The Company is in the process of finalizing the initial accounting for the business combination, with a deadline of December 15, 2024, for completing the measurement period[129]. Miscellaneous - The company operates in one segment: commercial, with performance evaluated by the chief operating decision maker[47]. - The company has no new accounting pronouncements that could significantly affect its financial statements, except for upcoming disclosures required by FASB[69]. - The Company recorded a change in fair value of the related party subscription agreement liability of approximately $928,000 for the three months ended September 30, 2024[183].

Financial Performance - Revenue for the three months ended June 30, 2024, was $704,848, compared to $1,405,281 for the same period in 2023, representing a decrease of approximately 50%[7] - Gross profit for the six months ended June 30, 2024, was $289,716, down from $1,115,565 in the previous year, indicating a significant decline[7] - Net loss for the three months ended June 30, 2024, was $(14,306,704), compared to a net loss of $(6,865,270) for the same period in 2023, which is an increase in loss of approximately 108%[7] - The company reported a total comprehensive loss of $(14,230,110) for the three months ended June 30, 2024, compared to $(6,865,270) for the same period in 2023, reflecting an increase in comprehensive loss of approximately 107%[7] - For the six months ended June 30, 2024, Onconetix reported a net loss of $25,425,276, compared to a net loss of $9,711,914 for the same period in 2023, indicating a significant increase in losses[10] - The net loss for the three months ended June 30, 2024, was approximately $14.3 million, compared to a net loss of $6.9 million in the same period in 2023, reflecting an increase of 108.4%[98] - The company reported a net loss of $14.3 million and $25.4 million for the three and six months ended June 30, 2024, respectively, with an accumulated deficit of $82.2 million[128] Assets and Liabilities - Current assets decreased from $5,838,271 to $2,035,448, a decline of approximately 65.2%[5] - Total assets decreased from $87,518,032 to $59,463,955, a decrease of approximately 32.0%[5] - Stockholders' equity decreased from $5,295,114 to $3,169,727, a decline of about 40.2%[6] - The balance of accumulated deficit as of June 30, 2024, was $(82,211,470), compared to $(56,786,194) at December 31, 2023, indicating an increase in deficit of approximately 45%[9] - As of June 30, 2024, the company had cash of approximately $930,541, down from $9,222,647 at the end of June 2023, highlighting a cash decrease of approximately 90% year-over-year[10] - The working capital deficit stood at approximately $18.6 million as of June 30, 2024, with an accumulated deficit of approximately $82.2 million[13] - As of June 30, 2024, the company had total current liabilities of approximately $20.6 million, including accounts payable of approximately $3.2 million and notes payable primarily due to Veru[133] Impairments and Expenses - Impairment of goodwill for the six months ended June 30, 2024, was $15,453,000, compared to $10,261,000 for the same period in 2023, showing an increase of approximately 51%[7] - The Company recorded an impairment loss of approximately $10.3 million related to goodwill and approximately $1.2 million on assets acquired from the ENTADFI acquisition during the three months ended June 30, 2024[102] - Total operating expenses for the three months ended June 30, 2024, were $13,715,735, compared to $6,649,600 in the same period of 2023, reflecting an increase of approximately 106%[7] - Total operating expenses for the six months ended June 30, 2024, increased by approximately $15.5 million compared to $9.5 million in the same period in 2023, marking a 163.1% increase[105] Strategic Focus and Risks - The company is focused on commercializing Proclarix and integrating assets from Proteomedix AG[4] - Future financial performance is subject to various risks, including the need for substantial additional capital[4] - The company is reliant on third parties for manufacturing and distribution, which poses potential risks[4] - Market acceptance of products and competition from existing therapies are critical for future growth[4] - The company has paused commercialization of ENTADFI and is exploring strategic alternatives, including a potential sale of the ENTADFI assets, due to cash constraints[11] - The company is considering strategic options for ENTADFI, including a potential sale or abandonment, as there is currently no plan to commercialize the product[134] Funding and Capital Needs - The company anticipates requiring significant additional capital in the short-term to fund ongoing operations and satisfy existing obligations[115] - Management's plans for funding include generating product revenue from Proclarix sales, which are still subject to successful commercialization[113] - The company plans to secure additional funding through equity or debt financings, but currently has no commitments in place for further financing[130] - If stockholder approval is not obtained by January 1, 2025, the Series B Convertible Redeemable Preferred Stock could be redeemable for approximately $41.9 million[113] Compliance and Regulatory Issues - The company reported stockholders' equity of $1,404,476 for the fiscal year ended December 31, 2023, which is below the Nasdaq minimum requirement of $2,500,000[137] - The company has until September 16, 2024, to regain compliance with the Nasdaq Bid Price Rule after receiving a notice of non-compliance due to a closing bid price below $1.00 per share[137] - The company has until November 4, 2024, to regain compliance with the Minimum Stockholders' Equity Requirement after submitting a compliance plan to Nasdaq[137] Operational Challenges - The company has incurred net losses since inception and expects to continue incurring losses, with significant fluctuations based on research and development activities[89] - There is substantial doubt about the company's ability to continue as a going concern within one year from the issuance of the financial statements[113] - The company has developed a remediation plan to address material weaknesses in internal controls, including the termination of the accounting employee involved in credit card misuse[125]

Financial Performance - Revenue for the three months ended March 31, 2024, was $700,433, compared to $0 for the same period in 2023[17] - Gross profit for the same period was $189,000, with a cost of revenue of $511,433[17] - Total operating expenses increased significantly to $11,270,990 from $2,848,259 year-over-year, driven by higher selling, general and administrative expenses and impairments[17] - The net loss for the three months ended March 31, 2024, was $11,118,572, compared to a net loss of $2,846,644 for the same period in 2023[17] - The company reported a loss per share of $0.50 for the three months ended March 31, 2024, compared to $0.18 for the same period in 2023[17] - For the three months ended March 31, 2024, Onconetix reported a net loss of $11,118,572, compared to a net loss of $2,846,644 for the same period in 2023, indicating a significant increase in losses[23] Assets and Liabilities - Total current assets increased to $6,294,697 as of March 31, 2024, from $5,838,271 as of December 31, 2023[15] - Total liabilities rose to $25,293,426 as of March 31, 2024, compared to $21,877,471 as of December 31, 2023[15] - The total stockholders' equity deficit increased to $14,497,912 as of March 31, 2024, from an equity of $1,404,476 as of December 31, 2023[15] - Cash and cash equivalents decreased slightly to $4,463,870 as of March 31, 2024, from $4,554,335 as of December 31, 2023[15] - As of March 31, 2024, Onconetix had cash of approximately $4.5 million and a working capital deficit of approximately $15.1 million[34] Impairments and Charges - The company recorded an impairment of goodwill amounting to $5,192,000 during the quarter[17] - The company recorded an impairment charge of $2.3 million during the three months ended March 31, 2024, primarily allocated to product rights intangible assets[63] - The company recorded a goodwill impairment charge of approximately $5.2 million during the three months ended March 31, 2024, due to a decline in stock price and market capitalization[69] - The company recorded a loss on impairment of $3.5 million due to the WraSer bankruptcy filing, as recovery of the initial payment is unlikely[99] Acquisitions and Strategic Moves - The company acquired Proteomedix AG on December 15, 2023, which became a wholly owned subsidiary, and previously acquired ENTADFI in April 2023[27] - The company acquired the ENTADFI product for a total possible consideration of $100 million, with initial cash payments totaling $20 million[74][75] - The total consideration transferred for the ENTADFI acquisition was $19,026,771, which included $6 million paid at closing and $12,947,000 in fair value of notes payable[84] - The Company recorded approximately $1.5 million in acquisition-related costs during 2023, which were expensed[120] - The PMX Transaction is expected to enhance Onconetix's prostate cancer treatment portfolio through Proteomedix's diagnostic expertise[107] Revenue Sources - Revenue for the three months ended March 31, 2024, was approximately $0.7 million, with $0.1 million from Proclarix product sales and $0.6 million from development services[52] - Development services revenue was entirely generated from the European Union, while product sales were 86% from the United States and 14% from non-European regions[52] Future Plans and Funding - Management plans to generate product revenue from sales of Proclarix and is seeking additional funding through equity or debt financings[35] - The company’s cash balance as of May 15, 2024, was approximately $1.9 million, which is expected to fund operations only into the third quarter of 2024[34] - The Company has paused the commercialization of ENTADFI and is exploring strategic alternatives, including a potential sale of the ENTADFI assets[211] - The Company is focusing efforts on commercializing Proclarix, an in vitro diagnostic test for prostate cancer[210] Stock and Financing Activities - The Company entered into a subscription agreement for the sale of 20 million units at $0.25 per unit, with a make-whole provision for additional shares if the stock price falls below $0.25[142] - The Company has authorized the issuance of 250 million shares of common stock and 10 million shares of preferred stock as of March 31, 2024[146] - The Company entered into an At The Market Offering Agreement to sell up to $3,900,000 of common stock, with a commission rate of 3.0% on gross proceeds[158] - The Company has outstanding warrants totaling 7,899,661 shares, with a weighted average exercise price of $1.68 per share[163] Employee and Management Changes - The Company terminated three employees involved with the ENTADFI program as part of a cost reduction plan, effective April 30, 2024[211] - The Company appointed Thomas Meier, PhD, to its board of directors, incurring related expenses of approximately $6,000[191]

Financial Performance - The company reported a net loss of $37.4 million for the year ended December 31, 2023, compared to a net loss of $13.4 million for 2022, resulting in an accumulated deficit of $56.8 million[13]. - As of December 31, 2023, the company had cash of approximately $4.6 million and a working capital deficit of approximately $11.4 million[14]. - The company generated negative operating cash flows of $13.6 million for the year ended December 31, 2023[13]. - The company has incurred substantial operating losses since inception and expects to continue incurring significant losses for the foreseeable future[14]. - The company expects to continue incurring net losses in the foreseeable future, with significant fluctuations in losses depending on various operational activities[165]. - The company will need to raise additional capital within the next 12 months to sustain operations, with no assurance that such capital will be available on acceptable terms[166]. - The company has substantial doubt about its ability to continue as a "going concern" and will require significant additional capital to execute its business plan[48]. - The company may face substantial doubt about its ability to continue as a going concern if it fails to generate sufficient revenue[166]. Capital Requirements and Funding - The company anticipates needing to raise substantial additional capital to fund ongoing operations and support commercialization efforts for Proclarix and ENTADFI[15]. - The company may explore strategic alternatives, including financing, alliances, or potential acquisitions, to maximize stockholder value[17]. - Economic uncertainty and macroeconomic conditions may adversely affect the company's access to capital and ability to execute its business plan[142][141]. - The company has received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement, with a plan submitted to regain compliance by September 16, 2024[174]. Commercialization and Product Development - The company has decided to temporarily pause the commercialization of ENTADFI while considering strategic alternatives[37]. - The company’s ability to commercialize its products successfully is subject to regulatory approvals and market acceptance[25]. - The company has temporarily paused the commercialization of ENTADFI due to cash runway and indebtedness considerations, with plans to reassess the program after appointing a new CEO in Q2 2024[161]. - Proclarix is expected to generate revenue by 2025, as it is CE-marked for sale in the European Union, although expenses related to commercialization are anticipated to increase substantially[162]. - The company has not generated any revenue from ENTADFI product sales and has only seen minimal development revenue from Proclarix since its acquisition[163]. - The company’s product development process involves high risks, and there is no assurance that development activities will yield commercially successful products[72]. Competition and Market Challenges - The company faces significant competition in the biotechnology sector, with competitors having greater resources and capabilities[40]. - The company is subject to competition from other BPH drugs and larger companies with greater resources, which may limit the market acceptance of ENTADFI[92]. - The company may not be able to gain and retain market acceptance for its products due to competition and changing customer preferences[63]. - The company faces intense competition in the biotechnology field, which may hinder its ability to attract and retain qualified personnel necessary for business success[138][147]. - The company may experience significant interruptions in the supply of ENTADFI and/or Proclarix if suppliers face manufacturing difficulties[61]. Operational Risks and Dependencies - The company relies on third-party manufacturers for ENTADFI and Proclarix, with no internal manufacturing capabilities, which poses risks related to supply chain dependencies[162]. - The company may face challenges in attracting and retaining qualified personnel due to competition in the life sciences sector[178]. - The company is highly dependent on senior management and key personnel, and losing them could delay product development and harm business operations[129]. - The company faces challenges in securing product components in a timely manner, which may affect production capacity and operating margins[105]. - The company relies on third-party contractors and suppliers, and disruptions in their performance could adversely affect business operations[117]. Strategic Direction and Corporate Changes - The company has changed its corporate name from "Blue Water Biotech, Inc." to "Onconetix, Inc." effective December 15, 2023[134]. - The acquisition of Proteomedix was completed on December 15, 2023, granting Proteomedix shareholders a 16.4% ownership stake in the newly named Onconetix[160]. - The company has deprioritized vaccine development programs, focusing instead on men's health and oncology, indicating a strategic shift in business operations[157][159]. - Future acquisitions may not strengthen the company's competitive position and could divert management attention, impacting operational efficiency[110]. Compliance and Regulatory Risks - Compliance with data protection laws, such as HIPAA, may require significant capital and resources to ensure ongoing compliance and protect against breaches[111]. - Unauthorized access to IT systems could lead to significant liabilities under privacy laws such as HIPAA, as well as regulatory investigations and penalties[1286]. - The company may incur substantial costs to prevent, detect, and remediate security breaches and other incidents[1286]. - Any perception of a security breach could adversely affect the company and its stockholders[1286]. Market Conditions and Economic Factors - The in vitro diagnostic industry may be affected by changes in supply, market prices, and economic conditions, potentially reducing demand for the company's products[118]. - The company may face adverse effects from macroeconomic pressures, including conflicts in Ukraine and the Middle East, which could alter business operations[115].

Strategic Focus - The company announced a strategic shift to focus on oncology, deprioritizing preclinical vaccine programs to enhance shareholder value and provide leading-edge therapeutics, diagnostics, and services[91]. - The company has deprioritized its vaccine discovery and development programs, now operating solely in the commercial segment focused on ENTADFI[102]. - The company signed a non-binding term sheet to acquire a private commercial stage oncology biotechnology company, which will further align with its new oncology focus[103]. Financial Performance - The company has a working capital deficit of approximately $8.1 million and an accumulated deficit of approximately $34.4 million as of September 30, 2023[111]. - The company incurred net losses since inception and expects to continue incurring losses in the foreseeable future, with significant fluctuations based on various operational activities[111]. - The company incurred a net loss of $5.3 million and $15.1 million for the three and nine months ended September 30, 2023, respectively, with an accumulated deficit of $34.4 million as of the same date[193]. - Total operating expenses for the nine months ended September 30, 2023, were $14.0 million, a 36.6% increase from $10.2 million in the same period in 2022[205]. - The company generated negative operating cash flows of $9.3 million for the nine months ended September 30, 2023[193]. - The company reported a net cash decrease of approximately $18.1 million for the nine months ended September 30, 2023[232]. Revenue Generation - The company expects to generate revenue from sales of ENTADFI, which is FDA-approved, in the near term, although expenses are anticipated to increase substantially due to commercialization activities[109]. - The company has not generated any revenue from product sales, relying on financing from preferred securities, IPO proceeds, and warrant exercises[133]. - The company has not generated any revenue from product sales aside from ENTADFI since its acquisition in April 2023[208]. Management Changes - Bruce Harmon was appointed as Chief Financial Officer on October 4, 2023, with an annual base salary of $325,000 and a target discretionary bonus of up to 30% of his salary[117]. - The Company appointed Dr. Neil Campbell as President and CEO on October 4, 2023, with an annual salary of $475,000 and a signing bonus of $75,000[138]. Agreements and Acquisitions - The company signed an agreement with UpScriptHealth to create a telemedicine platform for distributing ENTADFI, supporting patients throughout the prescription process[106]. - The company agreed to provide Veru with initial consideration totaling $20 million for the acquisition of ENTADFI, with specific payment terms outlined[119]. - The Company is set to acquire WraSer Assets for a total consideration of $9.5 million in cash and 1.0 million shares of common stock, with a $500,000 payment due one year after closing[122]. - The acquisition of ENTADFI® from Veru was for a total possible consideration of $100 million, with additional milestone payments of up to $80 million based on net sales[140][143]. - The Company entered into an Exclusive Distribution Agreement with Cardinal Health 105, LLC for the distribution of all commercial assets on September 21, 2023[129]. - The Company entered into a development and manufacturing agreement with Ology, with obligations increasing by $180,000 under the amended project addendum[153]. Compliance and Regulatory Matters - The Company regained compliance with Nasdaq Listing Rule 5250(c)(1) on November 1, 2023, after filing its Form 10-Q for the period ended June 30, 2023[126]. - The Company is required to regain compliance with Nasdaq's minimum bid price rule by March 16, 2024, after being notified of non-compliance[172]. - The company has filed a motion for relief from the automatic stay in the Bankruptcy Court to exercise termination rights under the WraSer APA due to a Material Adverse Effect[147]. Expenses and Financial Obligations - Selling, general and administrative expenses increased by approximately $1.0 million for the nine months ended September 30, 2023, mainly due to increased commercialization activities for ENTADFI of $2.2 million[190]. - Selling, general and administrative expenses increased by approximately $1.6 million (58.4%) for the three months ended September 30, 2023, primarily due to increased commercialization activities for ENTADFI[203]. - The Company has significant commercialization expenses expected for marketing, manufacturing, and distribution of ENTADFI®[132]. - The Company is required to pay a 6% royalty on sales of tadalafil-finasteride and milestone payments of up to $22.5 million based on sales achievements[144]. - A $3.5 million impairment loss was recorded on the deposit for the WraSer asset purchase agreement during the nine months ended September 30, 2023[191]. - An early termination fee of approximately $2.3 million will be recorded in the quarter ending December 31, 2023, following the termination of the Master Services Agreement[199]. Capital Needs - The company expects to require significant additional capital in the short term to fund ongoing operations and commercialization of ENTADFI, with potential financing through public or private equity or debt[210]. - The company anticipates needing significant additional capital to fund operations and support commercialization of ENTADFI, which has not yet been successfully commercialized[227]. - The company may face significant uncertainty in launching ENTADFI if adequate financing is not obtained[227]. Internal Controls - The company has developed a remediation plan for material weaknesses in internal control over financial reporting[248].

Financial Position - As of June 30, 2023, the company had cash of approximately $9.2 million and an accumulated deficit of approximately $29.1 million[272]. - The company reported a working capital deficit of approximately $0.7 million as of June 30, 2023[272]. - The company has a total debt of $13,160,995 after accounting for a debt discount of $839,005[179]. Operating Performance - Total operating expenses for the three months ended June 30, 2022, were $6.65 million, compared to $4.29 million for the same period in 2021, representing a 55% increase[261]. - The net loss for the three months ended June 30, 2023, was $6.87 million, compared to a net loss of $4.26 million for the same period in 2022, indicating a 61% increase in losses[261]. - The net loss per share attributable to common stockholders for the three months ended June 30, 2023, was $0.43, compared to $0.36 for the same period in 2022[261]. - The company had a weighted average number of common shares outstanding of 15,906,725 for the three months ended June 30, 2023[261]. Capital Needs and Funding - The company anticipates the need to raise substantial additional capital to fund its operations[255]. - The company is currently ineligible to file new short form registration statements on Form S-3, which may hinder its ability to raise capital efficiently[181]. Acquisitions and Investments - The company completed an acquisition of assets requiring an initial payment of $20 million, with $6 million paid at closing and $9 million due within one year[272]. - The company wrote off a $3.5 million advance payment related to an acquisition due to uncertainties following WraSer's bankruptcy filing[272]. - The company paid $3.5 million in cash to WraSer for the purchase of WraSer Assets, but the transaction is now uncertain due to WraSer's bankruptcy filing[162]. - The total possible consideration for the ENTADFI® acquisition was $100 million, with the company assuming certain trivial liabilities[175]. Regulatory and Compliance Issues - The company is focused on obtaining necessary regulatory approvals to market and commercialize its products and product candidates[255]. - The company may be subject to civil and criminal sanctions for potential violations of Section 13(k) of the Exchange Act, which could adversely affect its business and financial position[168]. - As of June 30, 2023, the company's disclosure controls and procedures were deemed ineffective due to material weaknesses identified in internal controls over financial reporting[162]. Internal Controls and Governance - The company has not maintained an effective control environment, leading to unauthorized payments being possible due to inadequate segregation of duties[157]. - An accounting employee involved in misuse has been terminated, and their roles have been reassigned to enhance control activities[194]. - The company plans to implement a formal information security policy to strengthen its internal controls[195]. - Material weaknesses in internal controls will be considered remediated once controls operate effectively for a sufficient period and management confirms their effectiveness through testing[196]. - There are inherent limitations on the effectiveness of internal control processes that the company must address[197]. - Changes in internal control over financial reporting have been noted, indicating ongoing adjustments to improve compliance and oversight[198]. Market Challenges - Company may face challenges in expanding sales of ENTADFI® through telemedicine partnerships or its own efforts due to a mature BPH market heavily dominated by generics[191]. - The company has a limited amount of analyst coverage, which may impact market perception and investment interest[193]. - As of September 18, 2023, the company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance deadline of March 16, 2024[192]. Shareholder Impact - The company may face significant dilution of ownership interests for shareholders due to the issuance or conversion of securities, including Series A Preferred Stock convertible into 5,709,935 shares of common stock[166].