Financial Performance - As of December 31, 2024, the company reported a working capital deficit of approximately $17.3 million and an accumulated deficit of approximately $113.0 million[28]. - The company has incurred net losses since inception and expects to continue doing so, with significant fluctuations in losses depending on various operational activities[28]. - The company incurred a net loss of $58.7 million and $37.4 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $115.7 million as of December 31, 2024[198]. - The company generated negative operating cash flows of $10.5 million for the year ended December 31, 2024[198]. - The company has cash of only $0.6 million, which raises concerns about its ability to meet current liabilities[208]. Product Development and Commercialization - The company has generated revenue only from Proclarix since its acquisition, while ENTADFI has not generated any revenue and commercialization activities have been abandoned[27]. - The company is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets, with no current plans to resume its commercialization[25]. - The company has abandoned the commercialization of ENTADFI due to cash runway and indebtedness, and the assets were fully impaired as of June 30, 2024[73]. - Proclarix is an in vitro diagnostic test for prostate cancer, approved for sale in the European Union, and aims to reduce unnecessary biopsies by providing a risk score for patients with elevated PSA levels[48]. - Proclarix is designed to aggregate multimodal information to develop a patient-centric diagnostic approach, with plans to enhance the risk score with additional biomarkers in the future[48]. Acquisitions and Partnerships - The acquisition of Proteomedix was completed on December 15, 2023, providing Proteomedix shareholders with an initial 16.4% ownership stake in the company[45]. - The acquisition of Proteomedix by Onconetix was valued at approximately $75 million, with 91,885 shares of Common Stock and 2,696,729 shares of Series B Preferred Stock issued as consideration[52]. - The Company purchased assets related to Veru's ENTADFI business for a total possible consideration of $100 million, with an initial payment of $20 million[68]. - The Company entered into a Subscription Agreement for a private placement of $5 million, with each unit consisting of one share of Common Stock and a warrant to purchase additional shares[61]. - Proteomedix entered an exclusive partnership with LabCorp in 2023 for the development and commercialization of Proclarix in the United States, receiving an upfront license fee and future royalty payments[109]. Regulatory and Compliance - The company has received multiple deficiency notices from Nasdaq regarding compliance with listing standards, including failure to maintain a minimum bid price and timely filing of reports[38][40]. - The maximum timeframe for the evaluation of a Marketing Authorization Application (MAA) by the EMA is 210 days, with potential accelerated reviews in urgent cases[147]. - The EMA requires a risk management plan (RMP) for all new MAAs, detailing measures to minimize risks associated with the product[153]. - Compliance with the General Data Protection Regulation (GDPR) is mandatory for processing personal health data in the EU, imposing significant obligations on pharmaceutical companies[137]. - Proteomedix has CE marked Proclarix IVDs under IVDD in 2019 and is now in compliance with IVDR, which includes performance and safety testing[161]. Market and Competitive Landscape - The global market for in vitro diagnostic (IVD) products is projected to reach $101 billion in 2024, with Europe and North America being the largest markets[116]. - In 2022, there were 1,467,854 new cases of prostate cancer and 397,430 related deaths worldwide, highlighting the significant market need for improved diagnostic tools[114]. - The molecular diagnostics field is highly competitive, with many companies developing tests that could pose technological and market access advantages over Proclarix[120]. - Proclarix aims to address the diagnostic "grey zone" where approximately 10% of men have elevated PSA levels, with only 20-40% presenting clinically with cancer[115]. - The use of MRI for prostate cancer diagnosis has increased, but costs range from $415 to $900, indicating a need for more accessible non-invasive diagnostic tests like Proclarix[119]. Operational Challenges - The company has significant debt obligations to Veru, including $10 million due, with forbearance agreements in place until June 30, 2025[204]. - The marketing approval process for Proclarix is lengthy and unpredictable, which may harm the company's business if approval is not obtained[209]. - The company may face significant delays and costs in obtaining foreign regulatory approvals for its products[217]. - Coverage and adequate reimbursement for the product may not be available, impacting its commercial success[219]. - The company has no manufacturing facilities and outsources the production of its IVD kits to a CMO in Germany[186].
Onconetix(ONCO) - 2024 Q4 - Annual Report