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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 11, 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 11, 2023, Blue Water Biotech, Inc., a
Delaware corporation (the “Company”), issued a press release announcing that it has entered into an agreement with Advantage
Point Solutions, LLC to support the Company’s market access strategy for its commercial pharmaceutical 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 11, 2023 |
By: |
/s/ Joseph Hernandez |
|
|
Joseph Hernandez |
|
|
Chief Executive Officer |
Exhibit 99.1
Blue Water Biotech Teams with Advantage Point
Solutions
to Provide Healthcare Payer Coverage Support
Pharmaceutical consulting firm to provide
Blue Water with access to
healthcare payers and PBMs
CINCINNATI, OH, July 11, 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 an agreement with Advantage Point Solutions, LLC (“APS”) to support Blue Water’s market access
strategy for its commercial pharmaceutical portfolio.
Since the purchase
of the approved product ENTADFI® in April and additional
approved therapies purchased in June, Blue Water has made significant progress in the advancement of its commercial strategy through the
establishment of key relationships and agreements. Blue Water’s agreement with APS follows its
recently announced agreements with IQVIA for the development of its medical sales representative team to market products to physicians
and bfw Advertising (“bfw”) for marketing and advertising services. Most recently, Blue Water was granted a license to operate
as a pharmaceutical wholesaler in its home state of Ohio and will look to expand its licenses nationwide in the future. With these agreements
in place, Blue Water believes it is assembling the key pieces to commercially launch and drive revenue from its approved product portfolio.
APS
will support market access for ENTADFI®, including assistance
in formulary negotiations with key healthcare payers and pharmacy benefit managers (“PBM”) in the commercial and government
sectors. With its robust network of relationships, APS helps commercial stage pharmaceutical companies build long-term relationships with
payers with the goal of maximizing access and reimbursement for approved pharmaceutical products. APS also has decades of experience advising
companies on product launches across a broad spectrum of therapeutic areas.
“Establishing
proper payer and PBM coverage is critical to the success of any product launch, as well as continued coverage throughout the product life
cycle to make sure patients can access affordable therapy,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue
Water. “As we progress towards the launch of ENTADFI®,
we will look to secure placement on key formularies to enable the execution of our commercialization strategies and aim to expand existing
formulary coverage for the newly acquired products. APS, with their proven track record of success in the market access space, will be
an invaluable partner for us as we move through the commercial landscape. Moreover, we are grateful that industry veterans like APS, IQVIA
and bfw are joining with us and validating our commercial plans.”
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 is
also in the process of acquiring the approved therapies from WraSer, LLC, and
Xspire Pharma, LLC, including ZONTIVITY® (reduction of thrombotic cardiovascular events in patients with
myocardial infarction or with peripheral arterial disease), OTOVEL® (acute otitis media with tympanostomy tubes),
CETRAXAL® (acute otitis externa), CONJUPRI® (hypertension), TREZIX™
(moderate to severe pain) and NALFON® (NSAID treatment for pain and inflammation).
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 Advantage Point Solutions (APS)
APS launched in 2012 with a singular focus: to
help pharmaceutical manufacturers bring new products to market in an ever-changing and complex payer environment. Our team has extensive
real-world payer experience, which enables us to define ground-breaking clinical, formulary, coverage, contracting and financial strategies,
as well as pull-through initiatives.
APS has extensive experience assisting pharmaceutical
manufacturers to optimize their U.S. market access through effectively planning the payer pre-launch, launch and post-launch strategies,
resulting in successful outcomes for our clients. APS can help manufacturer’s looking to outsource their managed care account facing
teams by working on behalf of our clients directly with payers on the full complement of formulary access and positioning responsibilities
including the following: development of the pricing and contracting strategies as well as the planning and execution of the payer engagement
to achieve the optimal access possible. For more information about APS, visit www.apsconsulting.com.
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 APS and the anticipated results of the Company’s sales and market efforts, each 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 establish, maintain and optimize key third party commercial collaboration
agreements (such as those with IQVIA, APS and bfw); risks related to the Company’s present need for capital to close its asset acquisitions,
commercially launch the Company’s acquired products and have adequate working capital; 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; 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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