Onconetix, Inc., (Nasdaq: BWV) ("Onconetix" or the “Company”) today
issued the following shareholder letter from the Company’s Chief
Executive Officer, Dr. Neil Campbell.
To Our Valued Shareholders,
As 2023 draws to a close, I am eager to share with you the
significant strides Onconetix, Inc. (formerly Blue Water Biotech,
Inc.) has made in our journey towards becoming a leader in
oncology. This past quarter has been transformative, marked by
strategic shifts and notable achievements, all aimed at enhancing
the value we bring to you as our shareholders.
To reflect our recent achievements and renewed oncology focus,
we have rebranded as Onconetix, Inc. This rebranding reflects a
transformation of the business to one focused on the research,
development and commercialization of proprietary science and
technologies for therapeutics, diagnostics, and services for the
treatment of cancer.
A key component of our focus is Entadfi®, an FDA-approved,
once-daily oral treatment for benign prostatic hyperplasia (BPH).
Set for launch in 2024, Entadfi® is poised to be an important
product in our oncology therapeutics portfolio and has the
potential to be a first-line treatment for BPH symptoms.
However, our larger strategy and vision for our commercial
portfolio is a dual therapeutic and diagnostic approach. With our
recent acquisition of Proteomedix, a commercial stage European
oncology diagnostics company headquartered in Zurich, Switzerland,
we have achieved just that. Now our cornerstone products are
Entadfi® for the treatment of benign prostatic hyperplasia and
Proclarix® for prostate cancer diagnostics.
In addition to significantly enhancing our emerging commercial
portfolio, the acquisition of Proteomedix and its diagnostic
platform marks a milestone in expanding our diagnostic capabilities
worldwide. Proclarix® is CE-certified and adhering to both European
(EAU) and American (AUA) guidelines. Proclarix® is already
available in Europe and will be introduced in the U.S. through an
exclusive partnership with a U.S. major laboratory corporation.
Joining the senior management team of Onconetix will be Dr.
Ralph Schiess, PhD, co-founder of Proteomedix, as Chief Science
Officer, and Mr. Christian Brühlmann, co-founder of Proteomedix, as
Chief Strategy Officer and General Manager of Europe.
Finally, in line with our commitment to oncology, we have
transitioned away from our preclinical vaccine programs. These
programs are now transitioning back to our vaccine partners,
ensuring their continued progress by others while we direct our
resources towards more targeted initiatives in oncology.
As you can see, our strategy, bolstered by our latest
acquisition, lays a solid foundation for Onconetix in the oncology
sphere. We are focused on cultivating key partnerships, acquiring
vital assets, and initiating our commercial revenue phase. Our goal
is to build a company that is not only focused on growth for
shareholders, but also on providing innovative solutions to
clinicians, patients, and caregivers.
Your continued support and trust in Onconetix are invaluable to
us. We are excited about the future and are committed to delivering
on our promise of bringing groundbreaking solutions to the field of
oncology.
Thank you for being a part of our journey.
Sincerely,
Dr. Neil J. CampbellPresident & CEOOnconetix, Inc.
About Onconetix, Inc.
Onconetix, Inc. (formerly Blue Water Biotech Inc. (BWV)) is a
commercial stage biotechnology company focused on the research,
development and commercialization of proprietary therapeutics,
diagnostics and services for clinicians and patients for oncology.
The Company currently has Entadfi®, an FDA approved, oral
therapeutic for the treatment of benign prostatic hyperplasia
(BPH), a disorder of the prostate, and Proclarix®, an advanced
proprietary diagnostic system for screening and diagnosis for men
with indeterminate Prostate Specific Antigen (PSA) assessments in
prostate cancer oncology. For more information, visit
www.onconetix.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 integrate the Transaction described herein;
risks related to Blue Water’s ability to commercialize ENTADFI® and
Proclarix® described herein; risks related to Blue Water’s ability
to expand its business scope and integrate the assets and
commercial operations acquired in the Transaction into Blue Water’s
business; risks related to Blue Water’s ability to attract, hire
and retain skilled personnel necessary to commercialize and operate
the company’s commercial products; 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 in oncology; 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. 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.
Investor and Media Contact Information:
Russo Partners, LLCNic Johnson and Harrison
Seidner, PhDTelephone: (212)
845-4242Email: Nic.Johnson@russopartnersllc.com
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