Zurich-Schlieren, Switzerland, December 18, 2023. Proteomedix AG, a spin-out of ETH Zurich, is a Swiss diagnostics company committed to advance prostate cancer care, today announced it has been acquired by US-based, NASDAQ-listed Blue Water Biotech Inc. (NASDAQ: BWV) in a share exchange transaction. The merged entity with the new name Onconetix Inc. combines two commercial-stage products for the diagnosis of prostate cancer and the treatment and benign prostate hyperplasia.
Under the terms of the agreement, Proteomedix shareholders will receive a mix of common shares and preferred shares. The preferred shares are subject to conversion into common shares anticipated during 1H2024. Upon this conversion and the expiry of a customary lock-up period for Proteomedix shareholders, all Onconetix shares issued to Proteomedix shareholders will become freely tradeable.
Onconetix Inc. will be led by Neil Campbell, PhD as CEO (recently appointed CEO of Blue Water Biotech Inc.). Together with Bruce Harmon (CFO), Proteomedix founders and executive managers Ralph Schiess, PhD and Christian Brühlmann will join the executive management team of Onconetix.
“I am very delighted about this transaction as the newly formed Onconetix combines two commercial-stage products for men’s health”, said Ralph Schiess, PhD, co-founder and CEO of Proteomedix and future CSO of Onconetix. “The combined leadership team will advance Onconetix’ commercial product launches for Entadfi®, an FDA-approved, once-daily oral therapeutic for the treatment of benign prostatic hyperplasia (BPH), and Proclarix®, a European CE IVD approved prostate diagnostics and a lab developed test (LDT).”
“On the occasion of this transaction, Proteomedix Management and Board would like to thank all our investors, shareholders, employees and business partners for their trust and support over the past years. There is a tremendous opportunity in leveraging the combined Proclarix® and Entadfi® diagnostic/treatment options to patients and their physicians. There is an unmet medical need to address prostate cancer/hyperplasia and Onconetix will offer state-of the-art medical solutions”, added Harry Welten, Chairman of the Board of Proteomedix.
Tungsten Advisors served as the exclusive financial advisor to Proteomedix. VISCHER and Nelson Mullins Riley & Scarborough served as legal counsels to Proteomedix. Viopas Venture Consulting advised the sellers in this transaction.
Proclarix® is CE-certified under IVDR 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 included in both the European (EAU) and American (AUA) guidelines.
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 Proteomedix AG
Proteomedix is a healthcare company whose mission is to transform prostate cancer diagnosis. The company has identified novel biomarker signatures with utility in prostate cancer diagnosis, prognosis and therapy management. The lead product Proclarix® is a blood based prostate cancer test panel and risk score currently available in Europe. Proteomedix is located in the Bio-Technopark of Zurich-Schlieren, Switzerland. For more information, visit www.proteomedix.com.
About Onconetix Inc.
Onconetix Inc. (formerly Blue Water Biotech Inc.; NASDAQ: 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.
Investor and Media Contact Information:
Russo Partners, LLC
Nic Johnson and Harrison Seidner, PhD
Telephone: (212) 845-4242