Blue Water Vaccines Reports Second Quarter 2022 Financial Results and Recent Business Highlights

·10-min read
  • Closed private placement in April 2022, with net proceeds of approximately $6.9 million

  • Signed 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 Relations
Telephone: (646) 942-5591
Email: Nic.Johnson@russopartnersllc.com

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