Blue Water Biotech Reports First Quarter 2023 Financial Results and Recent Business Highlights
May 12 2023 - 5:32PM
Blue Water Biotech, Inc. (“Blue Water” or the “Company”), a
biotechnology company spanning multiple sectors, today announced
its financial results for the quarter ended March 31, 2023 and
provided an update on recent business developments and Company
progress. Blue Water Biotech is a biological and pharmaceutical
technology company developing multiple preclinical vaccine
candidates across various infectious diseases and owns the
FDA-approved benign hyperplasia (“BPH”) asset, ENTADFI®.
“Blue Water’s recent growth is highlighted by our acquisition of
ENTADFI®, as well as our subsequent rebranding initiative and name
change to reflect our transition into a commercial-stage
biotechnology company,” said Joseph Hernandez, Chairman and Chief
Executive Officer of Blue Water. “We believe this product has the
potential to be transformative for men suffering from BPH, and we
are confident that our experienced management team will be the
driving force behind ENTADFI®’s anticipated success. We are also
excited to bring in an approved asset to support the operations for
our preclinical vaccine programs, including our Streptococcus
pneumoniae vaccine candidate that is progressing towards clinical
trials in the near term.”
Q1 2023 and Recent Corporate Developments
- In April 2023, Blue
Water announced the acquisition of ENTADFI®, an FDA-approved
treatment for BPH that counteracts negative sexual side effects
seen in men on alternative BPH therapies.
- Under the asset
purchase agreement, Blue Water purchased ENTADFI® for a total
consideration of up to $100 million, with $20 million upfront, paid
in defined tranches through September 2024, and the possibility of
an additional $80 million based on predetermined annual sales
milestones.
- Following this
acquisition, Blue Water announced in April 2023 that the Company
changed its corporate name to Blue Water Biotech, Inc. to reflect
its transition into a commercial-stage company.
- In February 2023,
Blue Water announced the appointment of seasoned commercial
operations leader Frank Jaeger as Senior Vice President of
Marketing and Business Development. Blue Water will leverage Mr.
Jaeger’s experience, specifically in Men’s Health through his
experience with JATENZO® and AndroGel 1.62%, in the official launch
of ENTADFI® and its anticipated success within the BPH market.
- Throughout the first quarter of 2023
and beyond, Blue Water management presented its corporate overview
and Company updates at key investor, financial, and scientific
conferences to highlight the value story of the Blue Water pipeline
and target leaders within the investment community.
- In January 2023,
Blue Water presented an overview of its vaccine candidate pipeline
and progress at Biotech Showcase 2023 during the 41st annual J.P.
Morgan Healthcare Conference Week in San Francisco, California. In
addition, Blue Water management participated in the World Vaccine
Congress in Washington D.C. in April 2023.
- To promote ENTADFI®
and connect with key leaders in the urology space, Blue Water
management sponsored a booth at the American Urological Association
Annual Meeting 2023 in Chicago, Illinois.
- In January 2023,
Blue Water announced the appointment of seasoned public market and
private equity investment leader, Timothy Ramdeen, to its board of
directors. Mr. Ramdeen has nearly a decade of experience in private
equity and hedge fund investing, capital markets, and company
formation.
Q1 2023 and Recent Vaccine Candidate
Developments
- In February 2023,
Blue Water announced a partnership with AbVacc, Inc. (“AbVacc”) for
the joint development of novel vaccine candidates targeting
monkeypox and Marburg virus disease, among others. The vaccine
candidates will utilize Blue Water’s norovirus shell and protrusion
virus-like particle platform, which allows for the presentation of
multiple antigens on the surface of either the S or P particle of a
norovirus backbone. Under this partnership, Blue Water and AbVacc
will work collaboratively to identify appropriate antigens to use
within this platform and will work toward clinical development of
vaccine candidates.
- In March 2023, Blue
Water signed a sponsored research agreement with The University of
Texas Health Science Center at San Antonio to initiate a non-human
primate study for Blue Water’s live attenuated, orally delivered
Chlamydia vaccine, BWV-401. In this study, non-human primates will
be vaccinated with BWV-401 and subsequently challenged against
Chlamydia to validate they hypothesis that this vaccine is both
safe and efficacious in a human-like model.
Q1 2023 Financial Highlights
- Cash
Position: Cash was $20.3 million as of March 31, 2023, as
compared to $25.8 million as of December 31, 2022. The decrease was
primarily due to an increase in various business activities to
support company growth, as well as increased research and
development activities.
- Research and
Development Expenses: For the three months ended March 31,
2023, research and development expenses increased by approximately
$0.6 million compared to the same period in 2022. The increase was
primarily attributable to an increase in preclinical development
activities of approximately $0.3 million mainly related to BWV-101
and BWV-201, and an increase in research and development personnel
costs.
- General and
Administrative Expenses: For the three months ended March
31, 2023, general and administrative expenses increased by $0.2
million compared to the same period in 2022. The increase was
mainly due to an increase in professional fees and an increase in
various business activities related to company growth and
development, such as business advisory services, travel, and rent
expenses. These increases were offset by a decrease in employee
compensation, as well as a non-recurring expense in the three
months ended March 31, 2022 to early terminate an agreement with an
underwriter, with no similar expense in the current period.
- Other
Income: Other income relates to the change in fair value
of the contingent warrant liability, which was incurred at the
close of the Company’s private placements in April and August 2022.
There was no other income or expense during the three months ended
March 31, 2022.
- Net
Loss: Net loss was approximately $2.8 million for the
three months ended March 31, 2023, as compared to $2.1 million for
the same period in 2022. The increase is primarily due to research
and development of preclinical vaccine candidates.
BLUE WATER BIOTECH,
INC.Condensed Balance Sheets
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
ASSETS |
|
(Unaudited) |
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash |
|
$ |
20,255,803 |
|
|
$ |
25,752,659 |
|
Restricted cash |
|
|
1,000,000 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
780,173 |
|
|
|
469,232 |
|
Deferred offering costs |
|
|
366,113 |
|
|
|
— |
|
Receivable from related parties |
|
|
70,302 |
|
|
|
35,850 |
|
Total current assets |
|
|
22,472,391 |
|
|
|
26,257,741 |
|
|
|
|
|
|
|
|
|
|
Prepaid expenses,
long-term |
|
|
15,500 |
|
|
|
38,617 |
|
Property and equipment,
net |
|
|
14,210 |
|
|
|
14,089 |
|
Total
assets |
|
$ |
22,502,101 |
|
|
$ |
26,310,447 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,503,262 |
|
|
$ |
1,499,296 |
|
Accrued expenses |
|
|
1,292,951 |
|
|
|
2,409,128 |
|
Contingent warrant liability |
|
|
12,406 |
|
|
|
14,021 |
|
Total current liabilities |
|
|
2,808,619 |
|
|
|
3,922,445 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities |
|
|
2,808,619 |
|
|
|
3,922,445 |
|
|
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.00001 par
value, 10,000,000 shares authorized at March 31, 2023 and December
31, 2022; 0 shares issued and outstanding at March 31, 2023 and
December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common stock, $0.00001 par
value, 250,000,000 shares authorized at March 31, 2023 and December
31, 2022; 16,371,597 and 15,724,957 shares issued at March 31, 2023
and December 31, 2022, respectively; 15,879,230 and 15,265,228
shares outstanding at March 31, 2023 and December 31, 2022,
respectively |
|
|
164 |
|
|
|
157 |
|
Additional
paid-in-capital |
|
|
42,516,726 |
|
|
|
42,331,155 |
|
Treasury stock, at cost;
492,367 and 459,729 shares of common stock at March 31, 2023 and
December 31, 2022, respectively |
|
|
(600,264 |
) |
|
|
(566,810 |
) |
Accumulated deficit |
|
|
(22,223,144 |
) |
|
|
(19,376,500 |
) |
Total stockholders’
equity |
|
|
19,693,482 |
|
|
|
22,388,002 |
|
Total liabilities and
stockholders’ equity |
|
$ |
22,502,101 |
|
|
$ |
26,310,447 |
|
BLUE WATER
BIOTECH, INC.Condensed Statements of
Operations(Unaudited)
|
|
Three Months Ended
March 31, 2023 |
|
|
Three Months Ended
March 31, 2022 |
|
Operating expenses |
|
|
|
|
|
|
General and administrative |
|
$ |
1,766,022 |
|
|
|
$ |
1,615,569 |
|
Research and development |
|
|
1,082,237 |
|
|
|
|
455,092 |
|
Total operating expenses |
|
|
2,848,259 |
|
|
|
|
2,070,661 |
|
Loss from operations |
|
|
(2,848,259 |
) |
|
|
|
(2,070,661 |
) |
Other income |
|
|
|
|
|
|
|
|
Change in fair value of contingent warrant liability |
|
|
(1,615 |
) |
|
|
|
— |
|
Total other income |
|
|
(1,615 |
) |
|
|
|
— |
|
Net loss |
|
$ |
(2,846,644 |
) |
|
|
$ |
(2,070,661 |
) |
Cumulative preferred stock
dividends |
|
|
— |
|
|
|
|
96,359 |
|
Net loss applicable to common
stockholders |
|
|
(2,846,644 |
) |
|
|
|
(2,167,020 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.18 |
) |
|
|
$ |
(0.34 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding, basic and diluted |
|
|
15,910,415 |
|
|
|
|
6,339,435 |
|
|
|
|
|
|
|
|
|
|
|
About ENTADFI®
ENTADFI® is an oral, once daily treatment for BPH that combines
finasteride, a 5α-reductase inhibitor, and tadalafil, a
phosphodiesterase 5 (PDE5) inhibitor, offering a more effective
treatment option compared to other available therapies. Clinical
trials have shown that ENTADFI® is more effective in treating
BPH symptoms, including urinary frequency, urgency, weak stream,
and difficulty initiating or maintaining urination, compared to
finasteride monotherapy. Additionally, ENTADFI® has
demonstrated a favorable safety profile, with fewer adverse sexual
side effects compared to finasteride. ENTADFI® reduces potential
for adverse sexual side effects, making it a preferred choice for
men seeking relief from BPH symptoms without compromising their
sexual health. ENTADFI® has received FDA approval for the
indication of initiating treatment of the signs and symptoms of BPH
in men with an enlarged prostate for up to 26 weeks. More
information about BPH and full ENTADFI® prescribing
information can be found on the product website at
https://entadfipatient.com/.
About Blue Water Biotech
Blue Water Biotech, Inc. is a biological and pharmaceutical
technology company focused on developing and providing
transformational therapies 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 Science
Center at San Antonio. Blue Water is developing a Streptococcus
pneumoniae vaccine candidate, designed to specifically prevent
highly infectious middle ear infections, known as acute otitis
media (AOM), in children, and prevention of pneumonia in the
elderly. The Company is also 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 Marburg and monkeypox, among others. Additionally, the
Company is developing a Chlamydia vaccine candidate with UT Health
Science Center San Antonio to prevent infection and reduce the need
for antibiotic treatment associated with contracting Chlamydia
disease. Outside of its vaccine franchise, Blue Water owns
ENTADFI®, an FDA-approved, once daily pill that combines
finasteride and tadalafil for the treatment of benign prostatic
hyperplasia. This combination allows men to receive treatment for
their symptoms of BPH without the negative sexual side effects
typically seen in patients on finasteride alone. For more
information about Blue Water, visit www.bwbioinc.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 Blue Water’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
Blue Water’s ability to realize the benefits of its acquisition of
ENTADFI®, risks related to BWV’s ability to expand its business
scope and its ability to commercialize ENTADFI®, risks related to
the development of Blue Water’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. Blue
Water does not undertake an obligation to update or revise any
forward-looking statement. Investors should read the risk factors
set forth in Blue Water’s Annual Report on 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 Blue Water’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@bwbioinc.com
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