Blue Water Vaccines Reports Second Quarter 2022 Financial Results and Recent Business Highlights
August 15 2022 - 4:00PM
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
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