Company Summary: Onconetix, Inc.

Business Focus and Core Activities

• Type: Commercial stage biotechnology company.
• Primary Focus: Research, development, and commercialization of solutions for men’s health and oncology.
• Main Products:
  • Proclarix: An in vitro diagnostic blood test for prostate cancer, based on proprietary protein biomarkers.
    • Uses a multi-parametric blood sample to generate a risk score aiding in prostate cancer diagnosis.
    • Approved for sale in the European Union under the IVDR.
    • Licensed to LabCorp for development and commercialization in the U.S.
  • ENTADFI: An FDA-approved oral medication combining finasteride and tadalafil for the treatment of benign prostatic hyperplasia (BPH).
    • Acquired from Veru Inc. in April 2023.
    • Currently not being marketed or sold, as the company has abandoned commercialization activities and is exploring sale or transaction of the assets.
• Other Assets: WraSer pharmaceutical assets (acquired via an asset purchase agreement), which are now fully impaired and no longer part of active operations.

Company Operations & Strategy

• Development & Marketing:
  • Focused on developing diagnostic, prognostic, and predictive tools, particularly for prostate cancer.
  • Licensing models primarily, with sales through third-party labs and distribution partners.
  • Collaborates with large companies like LabCorp for U.S. commercialization.
• Market & Reimbursement:
  • Currently not reimbursed in Europe; patients pay out of pocket.
  • Aims to secure reimbursement in key European markets.
  • Recognized by European and U.S. guidelines for Proclarix’s clinical utility.
• Manufacturing: Outsources production to third-party contract manufacturing organizations (CMOs) in Germany.
• Employees: As of May 30, 2025, the company has 7 employees (5 full-time and 2 subcontracted).
• Revenue:
  • 2024: $86,957 from sales of Proclarix.
  • 2023: $67,380 from sales of Proclarix (prior to acquisition).
• Financial Position:
  • Cash: Approximately $0.6 million as of December 31, 2024.
  • Net Losses: Reported $58.7 million in 2024 and $37.4 million in 2023.
  • Accumulated Deficit: Approximately $115.7 million as of December 31, 2024.
  • Working Capital Deficit: About $17.3 million as of December 31, 2024.
• Operations & Financial Outlook:
  • Continues to require substantial additional capital for operations and product commercialization.
  • Currently exploring sale or transaction of ENTADFI and WraSer assets due to strategic shift and financial constraints.

Recent Corporate Developments

• Acquisitions:
  • Proteomedix: Acquired in December 2023 via share exchange; shareholders received ~16.4% ownership initially, with Series B preferred convertible into over 6.7 million shares.
  • ENTADFI: Acquired in April 2023; commercialization abandoned, assets fully impaired.
  • WraSer assets: Acquired in June 2023; transaction terminated due to bankruptcy of seller.
• Strategic Moves:
  • Exploring sale or other transaction for ENTADFI assets.
  • Completed a private placement in October 2024 raising $1.9 million.
  • Engaged in a continued financing program including warrants, preferred stock, and a pipeline of new equity offerings.
• Executives & Board:
  • Karina M. Fedasz serves as Interim CEO since April 2025.
  • Management team and Board have extensive experience in life sciences, finance, and biotech industries.

Regulatory & Market Position

• Regulatory Approvals:
  • Proclarix is CE marked under IVDR, fully compliant with European regulations.
  • Pending or strategic plans for broader U.S. approval with LabCorp.
• Industry & Competition:
  • Competes with larger diagnostics companies like OPKO, Beckman Coulter, BioTechne, MdxHealth, and others.
  • Market opportunity centered on prostate cancer diagnostics with a large global market.
  • Currently operating in early market development stages with pilot labs and limited sales.

Key Metrics (As of May 30, 2025)

• Number of Shares Outstanding: 44,358,422 shares of common stock.
• Revenue (2024): $86,957
• Net Loss (2024): $58.7 million
• Employees: 7
• Market Capitalization (Based on June 30, 2024, stock price): Approximately $3.6 million (market value of stock held by non-affiliates).

Note: The company has shifted away from direct commercialization of ENTADFI and WraSer assets, focusing on licensing, partnerships, and potential asset sale strategies.