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Blue Water Vaccines Reports First Quarter 2022 Financial Results and Recent Business Developments

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  • Closed initial public offering of 2,222,222 shares of common stock at a public offering price of $9.00 per share, with aggregate gross proceeds of approximately $20 million
  • Multiple vaccine candidate developments, including additional data for universal influenza candidate, BWV-101, identifying additional epitopes of limited variability for H3N2 and influenza B strains
  • $18.6 million in Cash as of March 31, 2022

CINCINNATI, May 13, 2022 (GLOBE NEWSWIRE) -- Blue Water Vaccines Inc. (“BWV” or “Blue Water Vaccines” or “the Company”), today announced its financial results for the first quarter ended March 31, 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 influenza, norovirus, rotavirus, and acute otitis media (AOM) from Streptococcus pneumoniae colonization.

“The first quarter of this year had several exciting updates for Blue Water Vaccines, most notably the successful closing of our initial public offering,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water Vaccines. “We continue to advance our transformational vaccine pipeline to address significant global public health challenges and look forward to sharing additional developments throughout the rest of 2022.”

Q1 2022 and Recent Corporate Developments

  • On February 23, 2022, BWV closed its initial public offering of 2,222,222 shares of common stock at a public offering price of $9.00 per share, with aggregate gross proceeds of approximately $20 million. Boustead Securities, LLC acted as the sole book-running manager for the offering.
  • In February 2022, the Company appointed James Sapirstein, R.Ph., M.B.A. to the Blue Water Vaccines Board of Directors. Sapirstein has over 35 years of experience within the biotechnology sector and brings a strong combination of healthcare and business experience to the team.
  • In February 2022, the Company appointed John Rice, Ph.D. to its Scientific Advisory Board. In addition to his work in microbiology and virology early in his career, he brings over 30 years of experience in venture capital and previously served on the BWV board of directors before BWV’s IPO.
  • On April 19, 2022, BWV closed a private placement with gross proceeds of approximately $8.0 million.

Q1 2022 and Recent Vaccine Candidate Developments

  • On March 22, 2022, BWV announced that researchers at licensing partner Cincinnati Children’s Hospital Medical Center published a research paper in Nano Research supporting the versatility of the Company’s norovirus shell and protrusion (S&P) platform into influenza vaccine applications, in addition to the current utilization of this platform to develop a vaccine for gastroenteritis caused by norovirus or rotavirus, BWV-301.
  • On April 20, 2022, Brian Price, Ph.D., BWV’s Head of Technology Strategy, presented new data surrounding the Company’s development of BWV-101, a universal influenza vaccine candidate, at the World Vaccine Congress 2022 in Washington, DC. This data showed new evidence for epitopes of limited variability for influenza B and H3N2 strains in addition to those found previously for H1 at The University of Oxford. The Company hypothesizes that the combination of H1, H3N2, and influenza B epitopes within BWV-101 will provide high levels of protection against various potential strains and eliminate the need for yearly re-vaccination. Provisional patents have been filed for additional epitopes of limited variability in H3N2 and influenza B.
  • On May 11, 2022, BWV announced the expansion of its license agreement with St. Jude Children’s Research Hospital to pursue the research and development of BWV-201, an intranasal Streptococcus pneumoniae induced acute otitis media (AOM) vaccine candidate. This expanded research agreement funds research into the viability of this method as a vaccine platform to potentially provide protection against multiple pathogens, including non-typeable Haemophilus influenzae, which represents another leading cause of acute otitis media (AOM). The American Academy of Pediatrics reports over 5 million cases of AOM in the United States each year, resulting in approximately 30 million medical care visits and over 10 million antibiotic prescriptions.

Q1 2022 Financial Highlights

  • Cash position: Cash was $18.6 million as of March 31, 2022, as compared to $1.9 million as of December 31, 2021. The substantial increase was primarily due to the initial public offering, with gross proceeds of approximately $20 million. In addition, a private placement closed on April 19, with gross proceeds of approximately $8 million.
  • Research and development expenses: R&D expenses were $0.46 million for the three months ended March 31, 2022, as compared to $0.09 million for the same period in 2021. The increase was primarily due to an increase in preclinical development activities mainly related to BWV-201 and an increase in research and development personnel costs.
  • General and administrative expenses: G&A expenses were approximately $1.6 million for the three months ended March 31, 2022, as compared to $0.2 million for the same period in 2021. The increase was primarily due to an increase in legal, advisory, and other expenses associated with the initial public offering and an increase in headcount and related cost.
  • Net loss: Net loss was approximately $2.1 million as of March 31, 2022, as compared to $0.3 million for the same period in 2021.

BLUE WATER VACCINES INC.
Condensed Balance Sheets

  March 31,
2022
  December 31,
2021
 
ASSETS  (Unaudited)    
Current assets      
Cash $18,609,249  $1,928,474 
Prepaid expenses  90,005   234,551 
Deferred offering costs  238,804   757,646 
Receivable from related parties  164,515   152,524 
Total current assets  19,102,573   3,073,195 
         
Prepaid expenses, long-term  129,454    
Property and equipment, net  15,399   11,502 
Deposit  87,638    
Total assets $19,335,064  $3,084,697 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities        
Accounts payable $907,538  $582,605 
Accrued expenses  1,893,438   1,055,515 
Total current liabilities  2,800,976   1,638,120 
         
Commitments and Contingencies (see Note 7)        
         
Stockholders’ equity        
Preferred stock, $0.00001 par value, 10,000,000 shares authorized at March 31, 2022 and December 31, 2021        
Series Seed: 0 and 1,150,000 shares designated at March 31, 2022 and December 31, 2021, respectively; 0 and 1,146,138 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively; $0 and $15.4 million aggregate liquidation preference at March 31, 2022 and December 31, 2021, respectively     11 
Common stock, $0.00001 par value, 250,000,000 shares authorized at March 31, 2022 and December 31, 2021; 11,048,587 and 3,200,000 shares outstanding at March 31, 2022 and December 31, 2021, respectively  110   32 
Additional paid-in-capital  24,561,309   7,403,204 
Accumulated deficit  (8,027,331)  (5,956,670)
Total stockholders’ equity  16,534,088   1,446,577 
Total liabilities and stockholders’ equity $19,335,064  $3,084,697 

  
BLUE WATER VACCINES INC.
Condensed Statements of Operations
(Unaudited)

  Three Months Ended March 31,
2022
  Three Months Ended March 31,
2021
 
Operating costs and expenses      
General and administrative $1,615,569  $237,544 
Research and development  455,092   88,237 
Total operating expenses  2,070,661   325,781 
Loss from operations  (2,070,661)  (325,781)
         
Net loss $(2,070,661) $(325,781)
Cumulative preferred stock dividends  96,359   137,687 
Net loss applicable to common stockholders  (2,167,020)  (463,468)
         
Net loss per share attributable to common stockholders, basic and diluted $(0.34) $(0.14)
         
Weighted average number of common shares outstanding, basic and diluted  6,339,435   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 (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.

Investor Contact Information:
Investor Relations
Email: investors@bluewatervaccines.com 

Media Contact Information:
Media Relations
513-620-4101
Email: media@bluewatervaccines.com


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About BWV

developed by scientists at the prestigious oxford university in the uk, our vaccine protects against all influenza strains. it targets parts of the virus that are easy to induce a protective immune response against but also limited in variability. these regions of the virus were shown in thompson et al 2018 to direct the antigenic evolution of the influenza virus and therefore make ideal vaccine targets. the vaccine thus negates the need for (i) annual vaccination, providing potentially life-long protection against flu, and (ii) reformulation of the vaccine every few years.