BWV-101

Closed private placement in April 2022, with net proceeds of approximately $6.9 millionSigned multiple strategic agreements and collaborations to further vaccine candidate research, development, and manufacturing$22.2 million in cash as of June 30, 2022 CINCINNATI, Aug. 15, 2022 (GLOBE NEWSWIRE) -- Blue Water Vaccines Inc. (“BWV” or “Blue Water Vaccines” or “the Company”) today announced its financial results for the second quarter ended June 30, 2022 and provided an update on recent business developments and progress. Blue Water Vaccines is a pre-clinical stage biotechnology company developing vaccines against multiple infectious diseases, including acute otitis media (AOM) from Streptococcus pneumoniae colonization, influenza, norovirus, and rotavirus. “Blue Water Vaccines had several exciting updates in the second quarter of 2022, as we raised additional capital to support development of our vaccine pipeline,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water Vaccines. “Through additional agreements signed with our esteemed collaborators, such as The University of Oxford and St. Jude Children’s Research Hospital, we look forward to furthering our vaccine pipeline and transforming lives through novel vaccines.” Q2 2022 and Recent Corporate Developments On April 19, 2022, the Company closed a private placement with aggregate net cash proceeds of approximately $6.9 million.On August 11, 2022, BWV closed a private placement with aggregate net cash proceeds of approximately $8.8 million. Q2 2022 and Recent Vaccine Candidate Developments On April 20, 2022, Brian Price, Ph.D. and Head of Technology Strategy, presented new data supporting development of BWV’s universal influenza candidate, BWV-101, at the World Vaccine Congress in Washington, DC. This data, using mathematical modeling from The University of Oxford, identified two epitopes of limited variability in H3N2 influenza and one epitope in influenza B. These epitopes, along with previously identified epitopes in H1 influenza, will form the basis for BWV’s universal influenza candidate, BWV-101, to target broad protection against all three flu strains. Provisional patents have been filed for H3N2 and influenza B epitopes of limited variability.On May 11, 2022, the Company signed an expanded license agreement with St. Jude Children’s Research Hospital for further development of BWV-201, an intranasal Streptococcus pneumoniae induced acute otitis media (AOM) vaccine candidate. Through this expanded agreement, BWV will investigate presentation of additional antigens on the surface of the bacteria to potentially create a novel vaccine platform, including the three leading bacterial pathogens associated with AOM; Streptococcus pneumoniae, non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis.On May 19, 2022, BWV announced a collaboration with the multidisciplinary Center for R&D in Immunobiologics (“CeRDI”), an initiative of Instituto Butantan (“Butantan”), for the development of BWV’s universal influenza candidate, BWV-101, in Brazil. Butantan is the largest flu vaccine manufacturer in the Southern Hemisphere, with 100% of influenza vaccine doses used by the Brazilian Ministry of Health manufactured at Butantan.On May 16, 2022, the Company signed an amendment to its existing Sponsored Research Agreement with The University of Oxford for the development of BWV-101. This agreement extends funding for research and development of BWV-101 for an additional 18 months.On July 20, 2022, BWV announced the signing of a Sponsored Research Agreement with Cincinnati Children’s Hospital Medical Center (“Cincinnati Children’s”) to explore multiple vaccine candidates using BWV’s norovirus shell and protrusion (S&P) platform. The platform is being utilized to develop BWV-301, a vaccine for protection against gastroenteritis caused by norovirus or rotavirus. Under this agreement, BWV will fund additional research into this platform’s versatility across multiple diseases, including influenza and Alzheimer’s.On July 30, 2022, BWV researchers at licensing partner Cincinnati Children’s announced a publication titled “A Pseudovirus Nanoparticle-Based Trivalent Rotavirus Vaccine Candidate Elicits High and Cross P Type Immune Response” in Pharmaceutics. This study demonstrates additional utilization of BWV’s norovirus S&P platform through production of a novel rotavirus vaccine eliciting high and broad immunogenicity in mice against three predominant P-type rotaviruses. Q2 2022 Financial Highlights Cash Position: Cash was $22.2 million as of June 30, 2022, as compared to $18.6 million as of March 31, 2022. The increase was primarily due to the closing of a private placement that closed on April 19, 2022. After the additional private placement in August 2022, the Company’s current cash position is approximately $30.2 million and the Company believes its cash and cash equivalents are sufficient to fund operations through 2024.Research and Development Expenses: R&D expenses were $1.3 million for the three months ended June 30, 2022, as compared to $0.53 million for the same period in 2021. The increase was primarily due to an increase in employee compensation and stock-based compensation and increase in preclinical research and development activities mainly related to BWV-201, and an increase in external research and development personnel costs, offset by a decrease in license fees.General and Administrative Expenses: G&A expenses were approximately $3.0 million for the three months ended June 30, 2022, as compared to $0.3 million for the same period in 2021. The increase was primarily due to an increase in various business activities, including legal, advisory, and other expenses associated with being a newly public company, as well as an increase in employee compensation.Other Income: Other income relates to the change in fair value of the contingent warrant liability, which was incurred at the close of the private placement during the three months ended June 30, 2022. There was no other income or expense during the three months ended June 30, 2021.Net Loss: Net loss was approximately $4.3 million for the three months ended June 30, 2022, as compared to $0.8 million for the same period in 2021. The increase is primarily due to research and development of preclinical vaccine candidate development, as well as an increase in G&A expenses associated with now being a public company. BLUE WATER VACCINES INC.Condensed Balance Sheets June 30,2022 December 31,2021 ASSETS (Unaudited) Current assets Cash $22,242,183 $1,928,474 Prepaid expenses 1,013,004 234,551 Deferred offering costs 238,804 757,646 Receivable from related party 20,364 152,524 Total current assets 23,514,355 3,073,195 Prepaid expenses, long-term 73,974 — Property and equipment, net 17,780 11,502 Deposit 27,588 — Total assets $23,633,697 $3,084,697 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $972,971 $582,605 Accrued expenses 2,080,392 1,055,515 Contingent warrant liability 5,373 — Total current liabilities 3,058,736 1,638,120 Stockholders’ equity Preferred stock, $0.00001 par value, 10,000,000 shares authorized at June 30, 2022 and December 31, 2021 — — Series Seed: 0 and 1,150,000 shares designated at June 30, 2022 and December 31, 2021, respectively; 0 and 1,146,138 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively; $0 and $15.4 million aggregate liquidation preference at June 30, 2022 and December 31, 2021, respectively — 11 Common stock, $0.00001 par value, 250,000,000 shares authorized at June 30, 2022 and December 31, 2021; 12,229,399 and 3,200,000 shares outstanding at June 30, 2022 and December 31, 2021, respectively 122 32 Additional paid-in-capital 32,866,752 7,403,204 Accumulated deficit (12,291,913) (5,956,670)Total stockholders’ equity 20,574,961 1,446,577 Total liabilities and stockholders’ equity $23,633,697 $3,084,697 BLUE WATER VACCINES INC.Condensed Statements of Operations(Unaudited) Three Months Ended June 30, 2022 Three Months Ended June 30, 2021 Six Months Ended June 30, 2022 Six Months Ended June 30, 2021 Operating costs and expenses General and administrative $3,001,418 $262,732 $4,616,987 $500,276 Research and development 1,293,467 529,542 1,748,559 617,779 Total operating expenses 4,294,885 792,274 6,365,546 1,118,055 Loss from operations (4,294,885) (792,274) (6,365,546) (1,118,055)Other income Change in fair value of contingent warrant liability (30,303) — (30,303) — Total other income (30,303) — (30,303) — Net loss $(4,264,582) $(792,274) $(6,335,243) $(1,118,055)Cumulative preferred stock dividends — 139,217 96,359 276,904 Net loss applicable to common stockholders $(4,264,582) $(931,491) $(6,431,602) $(1,394,959)Net loss per share attributable to common stockholders, basic and diluted $(0.36) $(0.29) $(0.70) $(0.44)Weighted average number of common shares outstanding, basic and diluted 11,995,832 3,200,000 9,226,621 3,200,000 About Blue Water Vaccines Blue Water Vaccines Inc. is a biopharmaceutical company focused on developing transformational vaccines to address significant health challenges globally. Headquartered in Cincinnati, OH, the company holds the rights to proprietary technology developed at the University of Oxford, Cincinnati Children's Hospital Medical Center, and St. Jude Children's Hospital. The company is developing a universal flu vaccine that will provide protection from all virulent strains in addition to licensing a novel norovirus (NoV) S&P nanoparticle versatile virus-like particle (VLP) vaccine platform from Cincinnati Children’s to develop vaccines for multiple infectious diseases, including norovirus/rotavirus and malaria, among others. Additionally, Blue Water Vaccines is developing a Streptococcus pneumoniae (pneumococcus) vaccine candidate, designed to specifically prevent the highly infectious middle ear infections, known as Acute Otitis Media (AOM), in children. For more information, visit www.bluewatervaccines.com. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on BWV’s current expectations and actual results could differ materially and include, among others: statements regarding the satisfaction of the customary closing conditions of this private placement and the use of the proceeds from this private placement. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, market and other conditions, risks related to the development of BWV’s vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any vaccine under development, there are significant risks in the development, regulatory approval and commercialization of new products. BWV does not undertake an obligation to update or revise any forward-looking statement, except as required by law. Investors should read the risk factors set forth in BWV’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission on March 31, 2022, and periodic reports filed with the SEC on or after the date thereof. All of BWV’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof. Media Contact Information:Blue Water Media RelationsTelephone: (646) 942-5591 Email: Nic.Johnson@russopartnersllc.com Investor Contact Information:Blue Water Investor RelationsEmail: investors@bluewatervaccines.com

CINCINNATI, Aug. 17, 2022 (GLOBE NEWSWIRE) -- Blue Water Vaccines Inc. (“BWV” or “Blue Water Vaccines” or “the Company”), a biopharmaceutical company developing transformational vaccines to address significant global health challenges, today announced that the Company plans to explore the potential to develop a novel monkeypox vaccine using its norovirus shell and protrusion (S&P) virus-like particle (VLP) platform. The Company’s S&P platform is currently being utilized to develop vaccine candidates across multiple diseases, including BWV-101 for influenza, BWV-301 for gastroenteritis via norovirus or rotavirus infection, and BWV-302 for malaria. In this new effort, BWV will attempt to present monkeypox antigens within the S&P platform to potentially create a vaccine candidate capable of protecting individuals against monkeypox disease. “As monkeypox cases rise around the globe, BWV is committed to exploring the potential of our platform to create a novel monkeypox vaccine candidate,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water Vaccines. “Our VLP platform has previously demonstrated versatility across multiple infectious diseases, and we are excited to initiate this research to understand the potential to create another vaccine to fight this outbreak.” In July 2021, Blue Water Vaccines entered an exclusive, global licensing agreement with Cincinnati Children’s to develop vaccines for multiple infectious diseases utilizing the latter’s novel virus-like particle (VLP) vaccine platform. The platform leverages norovirus capsid proteins to present foreign antigens for immune enhancement. According to the World Health Organization, monkeypox is a virus transmitted to humans from animals, with clinical symptoms like those seen in smallpox patients. Human-to-human transmission can result from close contact with respiratory secretions, skin lesions of an infected person, or recently contaminated objects. According to the Centers for Disease Control and Prevention, there have been about 12,000 reported cases of monkeypox in the United States between May and August 2022. There are two vaccines approved for prevention of monkeypox disease in the United States, but limited availability of either vaccine has resulted in increasing cases within the US and globally. About Blue Water Vaccines Blue Water Vaccines Inc. is a biopharmaceutical company focused on developing transformational vaccines to address significant health challenges globally. Headquartered in Cincinnati, OH, the company holds the rights to proprietary technology developed at the University of Oxford, Cincinnati Children's Hospital Medical Center, and St. Jude Children's Hospital. The company is developing a universal flu vaccine that will provide protection from all virulent strains in addition to licensing a novel norovirus (NoV) S&P nanoparticle versatile virus-like particle (VLP) vaccine platform from Cincinnati Children’s to develop vaccines for multiple infectious diseases, including norovirus/rotavirus and malaria, among others. Additionally, Blue Water Vaccines is developing a Streptococcus pneumoniae (pneumococcus) vaccine candidate, designed to specifically prevent the highly infectious middle ear infections, known as Acute Otitis Media (AOM), in children. For more information, visit Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on BWV’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development of BWV’s vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any vaccine under development, there are significant risks in the development, regulatory approval and commercialization of new products. BWV does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in BWV’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2022, Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 15, 2022 and periodic reports filed with the SEC on or after the date thereof. All of BWV’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Media Contact Information: Blue Water Media Relations Telephone: (646) 942-5591 Email: Nic.Johnson@russopartnersllc.com Investor Contact Information: Blue Water Investor Relations Email: investors@bluewatervaccines.com