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 ...

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 March 31, 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) | --- | --- | --- | |-------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 81-2262816 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 W ...