Onconetix™ Chief Executive Officer Dr. Neil J. Campbell Issues Letter to Shareholders
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Insights
The strategic rebranding of Onconetix, Inc. and its shift towards oncology therapeutics and diagnostics represent a pivotal realignment of the company's core business. The introduction of Entadfi®, an FDA-approved treatment for benign prostatic hyperplasia, heralds the company's entry into the commercial phase and is expected to generate revenue starting in 2024. This product could significantly impact the BPH treatment market, potentially capturing a substantial market share if it becomes a first-line treatment.
The acquisition of Proteomedix adds a valuable asset in the form of Proclarix®, a CE-certified prostate cancer diagnostic tool, which complements the therapeutic side of the business. The expansion of diagnostic capabilities and the establishment of an exclusive partnership for U.S. distribution could enhance the company's competitive position in the oncology diagnostics market. These moves are likely to be viewed favorably by investors seeking growth in the specialized field of oncology.
However, the divestiture of preclinical vaccine programs indicates a narrowing of focus, which could limit diversification but also suggests a strategic allocation of resources to areas with higher expected returns. The long-term success of Onconetix will depend on the effective commercialization of its products and the integration of its acquisitions.
The oncology sector is highly competitive and rapidly evolving, with significant emphasis on innovation and precision medicine. Onconetix's strategic pivot towards a dual therapeutic and diagnostic approach could place the company at the forefront of personalized cancer care. The synergy between Entadfi® and Proclarix® could offer a comprehensive solution for prostate health management, potentially improving patient outcomes and streamlining clinical workflows.
Moreover, adherence to European (EAU) and American (AUA) guidelines by Proclarix® signifies a commitment to high standards and regulatory compliance, which is critical for market acceptance and expansion. The planned introduction of Proclarix® into the U.S. market, a major step for Onconetix, will require careful navigation of the complex regulatory environment and will be a key factor in determining the company's growth trajectory.
Furthermore, the appointment of Proteomedix's co-founders to Onconetix's senior management team could bring valuable expertise and insight, fostering innovation and strategic planning within the company. The impact of these leadership changes on the company's research and development capabilities will be an important area to monitor.
The pharmaceutical industry places a premium on strategic acquisitions that can quickly bring new products to market and expand a company's portfolio. Onconetix's acquisition of Proteomedix aligns with this trend and could be a catalyst for growth. The focus on both therapeutics and diagnostics within the oncology domain is a strategic move that may offer a competitive advantage by creating a more integrated approach to cancer care.
However, the success of such acquisitions hinges on the seamless integration of the new assets and the ability to leverage them effectively. The cross-border nature of the acquisition also introduces complexities in terms of operational management and cultural integration, which Onconetix will need to manage adeptly.
Additionally, the company's ability to navigate the reimbursement landscape for both Entadfi® and Proclarix® will be critical. Reimbursement challenges can significantly affect product adoption and market penetration. As such, Onconetix's strategies for engaging with insurance companies and healthcare providers will be crucial to their commercial success.
CINCINNATI, Dec. 19, 2023 (GLOBE NEWSWIRE) -- 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. Campbell
President & CEO
Onconetix, 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, LLC
Nic Johnson and Harrison Seidner, PhD
Telephone: (212) 845-4242
Email: Nic.Johnson@russopartnersllc.com
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