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]

As filed with the Securities and Exchange Commission on April 26, 2024 Registration No. 333-277066 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________ Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 E. Fifth Street, Suite 1900 Cincinnati, Ohio 45202 Telephone: (513) 620-4101 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant' ...

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].

As filed with the Securities and Exchange Commission on February 14, 2024 Registration No. 333-[_] UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (State or other jurisdiction of incorporation or organization) (Exact Name of Registrant as Specified in its Charter) _____________________ Delaware 2834 83-2262816 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 E. Fifth Street, Suite 1900 Cincinnati, Ohio 45202 Telephone: (513) 620-4101 F ...

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].

Financial Performance - Total current assets increased to $30,051,522 as of September 30, 2022, compared to $3,073,195 on December 31, 2021, representing a growth of approximately 877%[16] - Operating expenses for the three months ended September 30, 2022, were $3,869,734, a significant increase from $1,095,924 for the same period in 2021, reflecting a rise of about 253%[19] - The net loss for the three months ended September 30, 2022, was $3,866,662, compared to a net loss of $1,095,924 for the same period in 2021, indicating an increase in losses of approximately 253%[19] - Cash reserves rose to $29,136,716 as of September 30, 2022, up from $1,928,474 on December 31, 2021, marking an increase of about 1410%[16] - Total stockholders' equity reached $25,730,024 as of September 30, 2022, compared to $1,446,577 on December 31, 2021, representing a growth of approximately 1680%[16] - The company reported a net loss per share attributable to common stockholders of $0.27 for the three months ended September 30, 2022, compared to $0.40 for the same period in 2021, showing an improvement of 32.5%[19] - The company reported a net loss of $10,201,905 for the nine months ended September 30, 2022, compared to a net loss of $2,213,979 for the same period in 2021, indicating a significant increase in losses[26] - Cash used in operating activities was $5,897,641 for the nine months ended September 30, 2022, compared to $1,369,831 for the same period in 2021, reflecting a worsening cash flow situation[26] Capital Raising and Financing - The company completed its IPO on February 23, 2022, raising $17.1 million in net proceeds after underwriting discounts and costs[29] - The company received approximately $6.9 million in net cash proceeds from a private placement on April 19, 2022, and approximately $8.7 million from another private placement on August 11, 2022[34] - The company anticipates needing to raise additional capital to sustain operations and meet long-term requirements beyond one year from the issuance of the financial statements[35] - The company reported a net cash provided by financing activities of $33,115,222 for the nine months ended September 30, 2022, compared to a net cash used of $196,975 in the same period of the previous year[26] Research and Development - Research and development expenses for the nine months ended September 30, 2022, totaled $2,924,037, compared to $887,704 for the same period in 2021, reflecting an increase of about 229%[19] - The company incurred research and development expenses of approximately $496,000 and $988,000 for the three and nine months ended September 30, 2022, respectively, related to the Ology Bioservices project[176] - The company expanded its BWV-201 candidate to include pneumococcal pneumonia, hypothesizing that it can provide protection against various bacterial subtypes[198] - Research plans were initiated to investigate the applicability of the VLP platform for a novel monkeypox vaccine candidate[199] - A Sponsored Research Agreement was signed with Cincinnati Children's Hospital Medical Center to assess the VLP platform for developing vaccines for various diseases[200] Stock and Equity - The company had 14,689,851 shares outstanding as of September 30, 2022, compared to 3,200,000 shares on December 31, 2021, representing an increase of about 359%[16] - As of September 30, 2022, the total number of options to purchase shares of common stock excluded from diluted shares outstanding was 1,383,801[79] - The Company granted 200,000 stock options to the CEO, 200,000 to the CBO, and 100,000 to the CFO, with a total grant-date fair value of approximately $1.8 million[148] - The Company recognized stock-based compensation expense of approximately $0.2 million and $1.4 million for the CEO, CBO, and CFO during the three and nine months ended September 30, 2022, respectively[148] - The 2019 Equity Incentive Plan reserved 1,400,000 shares for issuance, while the 2022 Plan increased this to 2,600,000 shares[146] Liabilities and Obligations - Total liabilities increased to $4,431,377 as of September 30, 2022, from $1,638,120 on December 31, 2021, indicating a rise of approximately 171%[16] - The company is obligated to pay a 6% royalty on all net sales of licensed products under the Oxford University Innovation Limited agreement, with an annual minimum royalty payment of $250,000 starting post-product launch[165] - The company has milestone payment obligations of up to $51.25 million under the Oxford University Innovation Limited agreement, contingent on achieving specified development and regulatory milestones[165] - The company is required to pay milestone payments of up to $1.9 million under the St. Jude Agreement, contingent on achieving specified development and regulatory milestones[167] - The company has a commitment to pay CHMC milestone payments of up to $59.75 million, contingent on achieving specified development and regulatory milestones[173] Operational Insights - The company has not declared or paid any cash dividends and does not plan to do so in the foreseeable future[60] - The company has not generated any revenue from product sales and will require additional capital to fund operations and product development[205] - The company relies on third parties for conducting preclinical studies, clinical trials, and manufacturing, with no internal manufacturing capabilities[210] - The company does not expect to generate revenue from commercial product sales until successful development and regulatory approval of its vaccine candidates[209] - The company has incurred net losses since inception and expects to continue incurring losses in the foreseeable future[206]

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, 2022 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 Blue Water Vaccines Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of i ...