On December 18, 2023 Blue Water Biotech, Inc. (Nasdaq: BWV) ("BWB" or the "Company") reported the acquisition of Proteomedix AG, a private, commercial-stage diagnostics oncology company (the "Transaction"), and introduced a new name for the combined Company: Onconetix, Inc (Press release, Onconetix, DEC 18, 2023, View Source [SID1234641117]). The Transaction 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.
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The acquisition of Proteomedix for all stock consideration provides its shareholders with an initial 19.9% ownership stake of Onconetix.
With the transaction Onconetix establishes a European headquarter with operations in Zurich, Switzerland. Two members of Proteomedix’ leadership team will become executives of Onconetix.
Onconetix’s commercial products are Entadfi, an FDA-approved, once-daily oral therapeutic for the treatment of benign prostatic hyperplasia (BPH), and Proclarix, a European CE IVD approval for prostate diagnostics and a lab developed test (LDT) currently in the U.S., originally developed by Proteomedix.
The new focus of Onconetix aligns the business with the market value drivers in oncology and extensive life sciences company-building expertise of its new leadership team under the direction of President and CEO, Dr. Neil J. Campbell.
"As physicians and patients face a myriad of medical challenges, particularly in the area of benign prostatic hyperplasia (BPH) and prostate cancer, Onconetix is committed to innovation and bringing global leadership to this area of need," said Dr. Campbell. "This pivotal move not only expands our global footprint, it enables us to harness the advanced technological platform and diagnostic expertise of Proteomedix. Furthermore, it is an important step in our overall transformation as a Company that strengthens our core mission of enhancing shareholder value and positions us at the emerging forefront of prostate cancer diagnostics," said Dr. Campbell.
Tungsten Advisors served as the exclusive financial advisor to Proteomedix AG.
About ENTADFI
ENTADFI is a once-daily, oral treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, offering a more effective treatment option compared to other available therapies. We believe that ENTADFI will potentially improve the compliance issues in taking currently available therapies due to side effects associated with 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 Proclarix
Proclarix is CE-certified under IVDR in Europe and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer. Proclarix is available in Europe and expected to launch in the U.S. in 2024.