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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): July 6, 2023
Blue
Water Biotech, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-41294 |
|
83-2262816 |
(State or other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
201
E. Fifth Street, Suite 1900 Cincinnati, Ohio |
|
45202 |
(Address of Principal Executive
Offices) |
|
(Zip Code) |
Registrant’s
telephone number, including area code: (513) 620-4101
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class |
|
Trading
Symbol(s) |
|
Name
of Each Exchange on Which Registered |
Common Stock, par value
$0.00001 per share |
|
BWV |
|
The Nasdaq Stock Market
LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
8.01 Other Events.
On
July 6, 2023, Blue Water Biotech, Inc., a Delaware corporation (the “Company”), issued a press release announcing the signing
of a master services agreement with bfw Advertising Inc. to generate marketing and advertising material for the Company’s commercial
stage drug portfolio (the “Press Release”). The Press Release is attached hereto as Exhibit 99.1 and incorporated
herein by reference.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
|
Blue Water Biotech, Inc. |
|
|
|
Date: July 6,
2023 |
By: |
/s/
Joseph Hernandez |
|
|
Joseph
Hernandez |
|
|
Chief Executive Officer |
Exhibit 99.1
Blue Water Biotech Teams with BFW Advertising
to Market and Advertise Commercial Product Portfolio
CINCINNATI, OH, July
6, 2023 - Blue Water Biotech, Inc. (“Blue Water” or the “Company”) (Nasdaq: BWV), a biotechnology and pharmaceutical
company focused on developing and commercializing transformational therapies to address significant health challenges globally,
today announced the signing of a Master Services Agreement with bfw Advertising Inc. (“bfw”) to generate marketing and advertising
material for Blue Water’s commercial stage drug portfolio.
Based in Boca
Raton, Florida, bfw has more than three decades of experience supporting clinical and commercial stage life science companies, generating
effective and impactful brand campaigns, including digital, direct to consumer, and health care provider content. Bfw will work with Blue
Water’s commercial team to increase awareness for its commercial products through patient-facing materials, website updates, social
ads, targeted provider engagement, as well as materials to support Blue Water’s sales team, among other services.
“Signing
this agreement and generating an action plan with bfw is a critical step in the execution of our commercial launch strategy for our products,”
said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water. “By creating targeted, effective marketing materials,
we can maximize patient, healthcare provider, and payor awareness to ensure long-term success for Blue Water. With their impressive history
of campaigns in the life science industry, we are confident that bfw is the right firm for this endeavor, and we look forward to the official
launches of these programs in the coming months.”
“With
their recent acquisitions and shift into a commercial-stage as well as clinical-stage company, this is certainly an exciting time for
the team at Blue Water,” said Christian Boswell, President and Creative Director at bfw. “Through decades of working in the
life science industry, we understand the intricacies of marketing and advertising in this space and how challenging it can be for pharmaceutical
companies to create cohesive brands. Blue Water has built a strong portfolio of products in recent months, and we are honored to utilize
our institutional knowledge to support them and to help them navigate the commercial arena.”
Blue Water recently
expanded its operations to become a commercial stage company with the acquisition of several FDA approved assets across multiple indications,
including urology, cardiology, inner ear infections and pain management. Blue Water’s commercial team will work closely with BFW
to identify key areas where targeted advertising and marketing support can enhance product uptake and utilization in each respective market.
About Blue Water Biotech
Blue Water Biotech, Inc. is a biotechnology and
pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally.
Headquartered in Cincinnati, OH, the Company 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
benign prostatic hyperplasia without the negative sexual side effects typically seen in patients on finasteride alone. The Company also
has a robust vaccine pipeline. Blue Water 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 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 S&P nanoparticle versatile
virus-like particle 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. For more
information about Blue Water, visit www.bwbioinc.com.
About BFW Advertising
Bfw is a full-service integrated branding and
communications agency with a strong grounding in healthcare and pharma, supporting both clinical and commercial stage companies. Bfw has
worked across a broad range of brands and therapeutic areas, including men’s and women’s health, CNS, pediatrics, oncology,
pain management, pulmonary and HIV-associated disorders, as well as leading recruiting campaigns for clinical trial participants.
Cautionary Note Regarding 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 (including, without limitation, the anticipated benefits of the Company’s
agreement with BFW and the Company’s sales and marketing efforts as described herein) 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 acquisitions of ENTADFI®, ZONTIVITY®,
OTOVEL®, CETRAXAL®, CONJUPRI®, TREZIX™
and NALFON®; risks related to Blue Water’s ability to expand
its business scope, commercialize ENTADFI® and integrate the assets and commercial operations being acquired from WraSer
into Blue Water’s business; risks related to Blue Water’s ability to attract, hire and retain skilled personnel and establish
an effective sales team; risks related to Blue Water’s ability to enter into a definitive agreement with IQVIA and optimize its
collaboration with IQVIA; risks related to the development of Blue Water’s vaccine candidates; the failure to obtain FDA clearances
or approvals and noncompliance with FDA regulations;; 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 commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the
development, regulatory approval and commercialization of pharmaceutical 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
Email: Nic.Johnson@russopartnersllc.com
Investor Contact Information:
Blue Water Investor Relations
Email: investors@bwbioinc.com
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