Full Press Release Details
Blue Water Biotech Reports First Quarter 2023
Financial Results and Recent Business Highlights
CINCINNATI, OH, May 12, 2023 -- 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
Q1 2023 and Recent Vaccine Candidate Developments
Q1 2023 Financial Highlights
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
| 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 |
ENTADFI is an oral, once daily treatment for BPH that
combines finasteride, a 5 -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 Relations
Telephone: (646) 942-5591
Investor Contact Information:
Blue Water Investor Relations
Email: investors@bwbioinc.com