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].

Financial Performance - Total operating expenses for the three months ended March 31, 2023, were $2,848,259, compared to $2,070,661 for the same period in 2022, representing an increase of approximately 37.5%[69] - The net loss for the three months ended March 31, 2023, was $2,846,644, compared to a net loss of $2,070,661 for the same period in 2022, indicating an increase in losses of about 37.4%[69] - The net loss per share attributable to common stockholders for the three months ended March 31, 2023, was $(0.18), an improvement from $(0.34) in the same period of 2022[69] - Net cash used in operating activities was $4,446,083 for the three months ended March 31, 2023, significantly higher than the $886,091 used in the same period in 2022, indicating a substantial increase in cash outflows[72] - The company reported a net loss of $2,846,644 for the three months ended March 31, 2023, compared to a net loss of $2,070,661 for the same period in 2022, representing an increase in losses of approximately 37.4%[72] - The Company expects to continue incurring significant operating losses for the foreseeable future[122] Research and Development - Research and development expenses increased significantly to $1,082,237 for the three months ended March 31, 2023, from $455,092 in the same period of 2022, reflecting a growth of approximately 137.5%[69] - The Company is developing multiple vaccine candidates, including BWV-201 for pneumococcal diseases and BWV-101 and BWV-102 as universal influenza vaccines, all currently in pre-clinical development[95] - The Company incurred approximately $335,000 in research and development expenses during the three months ended March 31, 2023, compared to approximately $217,000 for the same period in 2022, reflecting an increase of about 54.3%[133] - The Company incurred approximately $8,000 in research and development costs related to a co-development agreement as of March 31, 2023, but determined that achieving specified milestones is not yet probable[109] - The Company has entered into a co-development agreement with AbVacc, Inc. for vaccine candidates, with milestone payments ranging from $2.1 million to $4.75 million, plus royalties of 2% to 4%[135] - The Company has a license agreement with St. Jude Children's Research Hospital, which includes milestone payments and royalties for developing a vaccine candidate for streptococcus pneumoniae[129] - The Company is utilizing a virus-like particle platform to develop vaccine candidates against various infectious diseases, including norovirus and malaria[95] Capital and Liquidity - The company has expressed the need to raise substantial additional capital to fund its operations, highlighting potential liquidity challenges[55] - The Company is required to secure additional capital to fund ongoing operations and product commercialization, with no current commitments for further financing[98] - Cash and restricted cash at the end of the period totaled $21,255,803, down from $25,752,659 at the beginning of the period, reflecting a decrease of approximately 17.5%[82] - The company completed its IPO on February 23, 2022, raising approximately $17.1 million in net proceeds after offering costs, which contributed to its financing activities[76] - The Company received net proceeds of approximately $17.1 million from its IPO after deducting underwriting discounts and offering costs[139] - The company has entered into an At The Market Offering Agreement to sell up to $3,900,000 of shares of common stock, with a commission of 3.0% on gross proceeds from each sale[173] Assets and Liabilities - Total liabilities decreased from $3,922,445 as of December 31, 2022, to $2,808,619 as of March 31, 2023, showing a reduction of approximately 28.4%[65] - Total stockholders' equity decreased from $22,388,002 as of December 31, 2022, to $19,693,482 as of March 31, 2023, reflecting a decline of about 12.1%[67] - The company had total current assets of $22,472,391 as of March 31, 2023, compared to $26,257,741 as of December 31, 2022, indicating a decrease of about 14.5%[89] - As of March 31, 2023, total accrued expenses decreased to $1,292,951 from $2,409,128 as of December 31, 2022, representing a reduction of approximately 46.4%[127] - Accrued research and development expenses were $549,762 as of March 31, 2023, down from $847,747 as of December 31, 2022, indicating a decrease of about 35.2%[127] Stock and Shareholder Information - The company had 15,905,732 shares of common stock outstanding as of May 12, 2023[52] - The company’s weighted average number of common shares outstanding increased from 6,339,435 as of March 31, 2022, to 15,910,415 as of March 31, 2023, reflecting the impact of the IPO and other equity transactions[91] - The Company repurchased 32,638 shares of common stock at an average price of $1.03 per share during the three months ended March 31, 2023, totaling approximately $33,500[140] - The Company has approximately 4.5 million shares remaining that can be repurchased under the Repurchase Program as of March 31, 2023[140] - The company has a stock repurchase program allowing the repurchase of up to 5.0 million shares of common stock at a maximum price of $2.00 per share, with no expiration date[165] Regulatory and Market Considerations - The company continues to evaluate the impact of the COVID-19 pandemic on its financial position and operations, indicating ongoing uncertainty in the market[46] - The company is focused on obtaining necessary regulatory approvals to market and commercialize its products, which is critical for future growth[60] - The Company has substantial doubt about its ability to continue as a going concern for one year from the issuance of the condensed financial statements due to historical and expected operating losses[80] Strategic Developments - The Company completed the acquisition of ENTADFI® in April 2023, requiring an initial payment of $20.0 million, with $6.0 million paid at closing and $9.0 million due within one year[122] - The company has hired key personnel, including a Senior Vice President of Marketing and Business Development and a Chief Medical Officer, to support the launch of ENTADFI[160] - The company announced a joint development agreement with AbVacc for vaccine candidates targeting monkeypox and Marburg virus disease, utilizing its norovirus shell and protrusion virus-like particle platform[161] - The company has developed a remediation plan for material weaknesses in its internal control over financial reporting[180]

Financial Position - The company has cash on hand sufficient to fund operations for at least the next 12 months following the report date, based on existing cash as of December 31, 2022[26]. - Significant additional capital will be required to execute the long-term business plan, and failure to raise this capital could lead to delays or termination of development programs[26]. Product Development - The company is in the early stages of vaccine development with no products approved for commercial sale, which may impact future viability[25]. - The company depends entirely on a limited number of product candidates that are currently in preclinical development, with none having commenced clinical trials[27]. - Regulatory approval for clinical trials of vaccine candidates in children may require additional studies due to stricter requirements[34]. - The company relies on third parties for clinical trials and research, and their performance may not meet expectations[30]. - The company is dependent on licensed intellectual property, and losing these rights could hinder development and commercialization efforts[32]. Operational Risks - The ongoing COVID-19 pandemic may adversely affect the company's operations and clinical trials[29]. - The company may face substantial costs from product liability lawsuits, which could limit commercialization of product candidates[21]. - Failure to comply with healthcare regulations could result in significant enforcement actions, adversely affecting business operations and financial condition[33].