Blue Water Vaccines Reports Year 2022 Financial Results and Recent Business Highlights
10 March 2023 - 12:30AM
Blue Water Vaccines Inc. (“BWV” or “Blue Water Vaccines” or the
“Company”), today announced its financial results for the fiscal
year ended December 31, 2022 and provided an update on recent
business developments and Company progress. Blue Water Vaccines is
a preclinical stage biotechnology company developing vaccines
against multiple infectious diseases, including acute otitis media
(“AOM”) and pneumonia from Streptococcus pneumoniae colonization,
influenza, norovirus, rotavirus, monkeypox, Marburg virus disease
and Chlamydia.
“In addition to our successful initial public offering and
raising subsequent capital to extend our runway, we made
significant corporate progress and further developed our vaccine
candidates throughout the year,” said Joseph Hernandez, Chairman
and Chief Executive Officer of Blue Water Vaccines. “We advanced
research of our Streptococcus pneumoniae vaccine candidate,
expanded its target indication to include both acute otitis media
and pneumococcal pneumonia, and are exploring the potential to
transform this vaccine into a platform to protect against other
respiratory pathogens. In addition, we continued to expand our
research endeavors with our esteemed network of collaborators and
highlighted our story to investment and scientific conferences
around the world. We are truly excited to build on this progress in
2023 and continue our mission to positively impact public health
for all.”
2022 and Recent Corporate Developments
- In February 2022, BWV closed its
initial public offering of 2,222,222 shares of common stock,
generating aggregate net proceeds of approximately $17.1
million.
- BWV closed private placements in
each of April and August of 2022, with aggregate net cash proceeds
of approximately $6.9 million and $8.7 million, respectively.
- In November 2022, the Board approved
a share repurchase program to allow for the Company to repurchase
up to 5 million shares, with discretion to management to make
purchases subject to market conditions.
- BWV named several seasoned
professionals to its board of directors, including Simon Tarsh,
retired Deloitte consulting Senior Managing Director, Vuk Jeremić,
previous chair of the Council of Europe’s Committee of Ministers
and previous President of the United Nations Assembly, as well as
Timothy Ramdeen, experienced public market and private equity
investment leader.
- In February 2023, BWV appointed
veteran commercial operations leader Frank Jaeger as Senior Vice
President of Marketing and Business Development to support BWV as
its pipeline programs progress towards clinical development.
- In December 2022, BWV received “buy”
recommendations from two notable healthcare-focused Wall Street
banks, Maxim Group LLC and H.C. Wainwright & Co.
- Throughout 2022 and into the first
quarter of 2023, BWV management presented its corporate overview
and Company updates at key investor and financial conferences to
highlight the value story of the BWV pipeline and target leaders
within the investment community.
2022 and Recent Vaccine Candidate
Developments
- On October 11, 2022,
the Company announced plans to evaluate the ability of BWV-201, a
live attenuated Streptococcus pneumoniae vaccine candidate, to
protect individuals against non-invasive pneumococcal pneumonia in
children and adults. Given BWV-201 is delivered intranasally,
rather than intramuscularly like the current pneumococcal vaccines
on the market, BWV-201 is designed to elicit mucosal immunity and
protect against disease in the lungs.
- In December 2022,
BWV signed an exclusive, global license agreement for a novel
Chlamydia vaccine candidate from the University of Texas Health at
San Antonio. Currently, there are no available vaccines to prevent
Chlamydia infection and the main treatment is through antibiotic
regimens. Chlamydia is the most frequently reported bacterial
sexually transmitted infection in the United States, with about 1.6
million new cases reported in 2020 alone, and globally, there are
an estimated 129 million cases each year. BWV’s novel vaccine
candidate is a live attenuated Chlamydia strain delivered orally
and is hypothesized to provide transmucosal protection in the
genital tract to prevent disease.
- Throughout 2022 and
into the first quarter of 2023, BWV expanded the exploration of the
applicability of its virus-like particle (“VLP”) platform into
multiple disease indications. Based on technology from Cincinnati
Children’s Hospital Medical Center (“Cincinnati Children’s”), BWV’s
VLP platform utilizes norovirus shell and protrusion particles to
self-assemble into VLPs, capable of presenting antigens from
various infectious diseases to create novel vaccine candidates.
- In March 2022, VLP
licensing partner Cincinnati Children’s published a research paper
in Nano Research supporting the utilization of the VLP platform to
present influenza antigens. BWV intends to explore the addition of
its epitopes of limited variability, which serve as the basis for
BWV’s universal influenza vaccine candidate, BWV-101, and
pre-pandemic H1 vaccine, BWV-102, into the VLP platform for vaccine
development.
- In February 2023,
BWV announced a collaboration with AbVacc, Inc. (“AbVacc”) for the
joint development of vaccine candidates targeting monkeypox and
Marburg virus disease. In this effort, BWV and AbVacc will utilize
BWV’s VLP platform to present antigens from each disease to develop
novel vaccine candidates, with the potential to expand this
partnership to other disease areas of interest identified by BWV
and AbVacc.
- To highlight its
novel vaccine candidates, BWV management presented pipeline details
and updates at several key scientific conferences throughout 2022
and into the first quarter of 2023, including the World Vaccine
Congresses in Washington, D.C., Barcelona, and San Diego, as well
as at the Universal Influenza Vaccines 2022 Conference in Oxford,
and the Biotech Showcase during the 41st Annual JP Morgan
Healthcare Conference
- In addition to
external events to highlight BWV’s vaccine pipeline, BWV held its
first Key Opinion Leader event in December 2022 to discuss the
unmet need for an AOM and pneumococcal pneumonia vaccine. During
the discussion, BWV-201 inventor Jason Rosch, Ph.D., and BWV
consultant, Ali Fattom, Ph.D., presented the importance of mucosal
immunity in vaccines and key data supporting BWV-201 as a solution
for AOM and pneumococcal pneumonia.
- Throughout 2022, BWV
expanded research and license agreements with esteemed
collaborators to further advance vaccine candidates.
- In May 2022, BWV
announced an expanded license agreement with St. Jude Children’s
Research Hospital (“St. Jude”). Under this agreement, BWV will
explore the potential to display additional pathogens capable of
causing AOM, including non-typeable Haemophilus influenzae (“NTHi”)
and Moraxella catarrhalis (“M. catarrhalis”), on the surface of
BWV-201, a live attenuated, serotype independent, intranasally
delivered Streptococcus pnuemoniae (“S. pneumoniae”) vaccine
candidate. At the World Vaccine Congresses in Barcelona and San
Diego, BWV presented data supporting this venture, showing that
epitopes from these otopathogens were successfully displayed on the
surface of BWV-201 and mice vaccinated with the new construct were
able to generate antibodies against NTHi, M. catarrhalis, and S.
pneumoniae.
- In May 2022, BWV
announced a collaboration with the multidisciplinary Center for
R&D in Immunobiologics, an initiative of Instituto Butantan
(“Butantan”). Through this partnership, BWV and Butantan will
develop BWV’s universal influenza vaccine candidate, BWV-101, in
Brazil.
- In May 2022, BWV
announced an expanded Sponsored Research Agreement with the
University of Oxford to continue funding development of BWV’s
universal influenza vaccine candidate, BWV-101. This, along with
the discovery of epitopes of limited variability in H3 influenza
and influenza B, will allow BWV to progress BWV-101 through its
preclinical development and reach clinical-stage.
- In July 2022, BWV
signed a Sponsored Research Agreement with Cincinnati Children’s to
fund research into exploring the applicability of its VLP platform
across multiple diseases, including rotavirus, norovirus, malaria,
and influenza. Through further agreements and announcements,
exploration of this platform has expanded to also include monkeypox
and Marburg virus disease.
2022 Financial Highlights
- Cash
Position: Cash was $25.8 million as of December 31, 2022,
as compared to $1.9 million as of December 31, 2021. The increase
was primarily due to the closing of BWV’s initial public offering
in February 2022, a private placement that closed on April 19,
2022, and a private placement that closed on August 11, 2022. The
Company believes its cash and cash equivalents are sufficient to
fund operations through at least the end of the third quarter of
2024.
- Research and
Development Expenses: For the year ended December 31,
2022, research and development expenses increased by approximately
$2.8 million compared to 2021. The increase was primarily
attributable to an increase in employee compensation and benefits,
an increase in preclinical 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: For the year ended December 31,
2022, general and administrative expenses increased by
approximately $7.3 million to $9.4 million from $2.1 million in
2021. The increase was mainly due to an increase in employee and
director compensation and benefits, an increase in professional
services related to being a public company and increases in various
business activities related to company growth and development.
- Other
Income: Other income of $61,410 for the year ended
December 31, 2022 relates to the change in fair value of the
contingent warrant liability, which was incurred at the close of
the April and August Private Placements. There was no other income
or expense during the year ended December 31, 2021.
- Net
Loss: Net loss was approximately $13.4 million for the
year ended December 31, 2022, as compared to $3.4 million for the
year ended December 31, 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. |
Balance Sheets |
|
|
December 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
ASSETS |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash |
|
$ |
25,752,659 |
|
|
$ |
1,928,474 |
|
Prepaid expenses and other current assets |
|
|
469,232 |
|
|
|
234,551 |
|
Deferred offering costs |
|
|
— |
|
|
|
757,646 |
|
Receivable from related parties |
|
|
35,850 |
|
|
|
152,524 |
|
Total current assets |
|
|
26,257,741 |
|
|
|
3,073,195 |
|
|
|
|
|
|
|
|
|
|
Prepaid expenses, long-term |
|
|
38,617 |
|
|
|
— |
|
Property and equipment, net |
|
|
14,089 |
|
|
|
11,502 |
|
Total assets |
|
$ |
26,310,447 |
|
|
$ |
3,084,697 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,499,296 |
|
|
$ |
582,605 |
|
Accrued expenses |
|
|
2,409,128 |
|
|
|
1,055,515 |
|
Contingent warrant liability |
|
|
14,021 |
|
|
|
— |
|
Total current liabilities |
|
|
3,922,445 |
|
|
|
1,638,120 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
3,922,445 |
|
|
|
1,638,120 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.00001 par value, 10,000,000 shares authorized
at December 31, 2022 and 2021 |
|
|
|
|
|
|
|
|
Series Seed: 0 and 1,150,000 shares designated at December 31, 2022
and 2021, respectively; 0 and 1,146,138 shares issued and
outstanding at December 31, 2022 and 2021, respectively; $0 and
$15.4 million aggregate liquidation preference at December 31, 2022
and 2021, respectively |
|
|
— |
|
|
|
11 |
|
Common stock, $0.00001 par value, 250,000,000 shares authorized at
December 31, 2022 and 2021; 15,724,957 and 3,200,000 shares issued
at December 31, 2022 and 2021, respectively; 15,265,228 and
3,200,000 shares outstanding at December 31, 2022 and 2021,
respectively |
|
|
157 |
|
|
|
32 |
|
Additional paid-in-capital |
|
|
42,331,155 |
|
|
|
7,403,204 |
|
Treasury stock, at cost; 459,729 and 0 shares of common stock at
December 31, 2022 and 2021, respectively |
|
|
(566,810 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(19,376,500 |
) |
|
|
(5,956,670 |
) |
Total stockholders’ equity |
|
|
22,388,002 |
|
|
|
1,446,577 |
|
Total liabilities and stockholders’ equity |
|
$ |
26,310,447 |
|
|
$ |
3,084,697 |
|
BLUE WATER VACCINES INC. |
Statements of Operations |
|
|
Year Ended |
|
|
Year Ended |
|
|
|
December 31, 2022 |
|
|
December 31, 2021 |
|
Operating expenses |
|
|
|
|
|
|
General and administrative |
|
$ |
9,351,552 |
|
|
$ |
2,092,304 |
|
Research and development |
|
|
4,129,688 |
|
|
|
1,325,030 |
|
Total operating expenses |
|
|
13,481,240 |
|
|
|
3,417,334 |
|
Loss from operations |
|
|
(13,481,240 |
) |
|
|
(3,417,334 |
) |
|
|
|
|
|
|
|
|
|
Other income |
|
|
|
|
|
|
|
|
Change in fair value of contingent warrant liability |
|
|
(61,410 |
) |
|
|
— |
|
Total other income |
|
|
(61,410 |
) |
|
|
— |
|
Net loss |
|
$ |
(13,419,830 |
) |
|
$ |
(3,417,334 |
) |
Cumulative preferred stock dividends |
|
|
96,359 |
|
|
|
627,391 |
|
Net loss applicable to common stockholders |
|
$ |
(13,516,189 |
) |
|
$ |
(4,044,725 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common stockholders, basic and
diluted |
|
$ |
(1.10 |
) |
|
$ |
(1.26 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding, basic and
diluted |
|
|
12,271,449 |
|
|
|
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, St. Jude Children’s Hospital, and The University of Texas
Health at San Antonio (“UT Health”). 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, and prevention of pneumonia in older people at risk for
contracting pneumococcal pneumonia, a significant unmet medical
need. The advantage of this technology includes a serotype
independent mucosal immunity that prevents colonization in the
upper respiratory tract as well as systemic immunity that can
confer serotype independent against invasive pneumococcal disease.
The Company is also developing a Chlamydia vaccine candidate with
UT Health to prevent infection and reduce the need for antibiotic
treatment associated with contracting Chlamydia disease. 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 include, but are not limited to,
statements concerning the Company's ability to implement its
business strategy and operations, its cash needs, the development
and efficacy of the Company’s vaccine candidates, and the Company's
anticipated future growth strategy. 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 Form 10-K , filed with the Securities
and Exchange Commission (the “SEC”) on March 9, 2023 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
RelationsTelephone: (646) 942-5591 Email:
Nic.Johnson@russopartnersllc.com
Investor Contact Information:Blue Water Investor RelationsEmail:
investors@bluewatervaccines.com
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