BWV-101

CINCINNATI, May 31, 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 the signing of an amendment to its existing Sponsored Research Agreement with The University of Oxford. Under this amendment, BWV will extend funding for research into its universal influenza vaccine candidate, BWV-101, for an additional 18 months. Under the original agreement signed in December 2019, BWV agreed to fund research and development of its universal influenza vaccine at The University of Oxford for a period of three years, ending on December 19, 2022. The signing of this amendment, as well as additional funding provided by BWV, will enable Oxford to continue research and optimization of the Company’s universal influenza vaccine candidate, BWV-101. “We are thrilled to continue our partnership with The University of Oxford,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water Vaccines. “In addition to the original work on H1 epitopes of limited variability, the team at Oxford recently found epitopes of limited variability for H3 and influenza B. This work brings us one step closer to a truly universal influenza vaccine, and we look forward to reaching that milestone with our partners at Oxford.” According to the World Health Organization, there are more than 1 billion influenza infections each year, 3 – 5 million of which are considered severe, leading to between 290,000 – 650,000 related respiratory deaths worldwide. Current influenza vaccines have several shortcomings, including yearly reformulations 6 months prior to influenza season leading to yearly administration and typically provide protection to only 50% of the individuals that receive the vaccine. Additionally, the CDC estimates about $87.1 billion USD is lost through absenteeism and healthcare costs in the US and the WHO estimates around $4 billion US is spent on the flu vaccine each year. Both the clinical toll of this disease and the economic burden it poses warrants investigation and commitment to the development of a universal influenza vaccine. About The University of Oxford Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the sixth year running, and 2 in the QS World Rankings 2022. At the heart of this success is our ground-breaking research and innovation. Oxford is world-famous for research excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research sparks imaginative and inventive insights and solutions. Through its research commercialization arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988. Over a third of these companies have been created in the past three years. The university is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full time jobs. 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 (CCHMC), 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 CCHMC 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. 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, including, but not limited to BWV-301; 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, 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:Media Relations513-620-4101Email: media@bluewatervaccines.com

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