Actinium Pharmaceuticals, Inc.
Climate Impact & Sustainability Data (2019)
Reporting Period: 2019
Environmental Metrics
Climate Goals & Targets
Environmental Challenges
- Limited operating history and no revenue from product sales.
- Net losses in every year since inception.
- Dependence on the success of Iomab-B and the SIERRA trial.
- Lack of commercial sales and marketing capabilities.
- Potential adverse effects from the COVID-19 pandemic on clinical trials and operations.
- Potential disagreements with FDA or comparable foreign regulatory authorities regarding regulatory plans.
- Difficulties enrolling patients in clinical trials.
- Reliance on third parties for clinical trials and manufacturing.
- Potential for undesirable side effects or other properties that could halt clinical development or limit commercial potential.
- Intellectual property related to licensed antibodies may have expired or may expire.
- Potential insufficient supply of isotopes to support clinical development or commercial scale.
- Competition from other biotechnology and pharmaceutical companies.
- Potential conflicts with partners.
- Potential for limited or unavailable coverage and reimbursement in certain market segments.
- Potential claims of wrongful use or disclosure of confidential information.
- Managing growth as operations expand may strain resources.
- Potential for acquisitions to disrupt business or dilute stockholder ownership.
- Common stock is considered a penny stock.
- Potential delisting from NYSE American.
- Price volatility of common stock.
- No dividends paid on common stock.
- Certificate of Incorporation and Bylaws provisions make acquisitions more difficult.
- Compliance with reporting requirements of federal securities laws can be expensive.
- Ability to utilize net operating loss carryforwards may be limited.
- Failure to establish and maintain adequate finance infrastructure and accounting systems and controls.
Mitigation Strategies
- Issued and sold 210.8 million shares of common stock in April 2020, raising $31.6 million in gross proceeds.
- Implemented remote working in response to COVID-19.
- Continuously evaluating I-131 manufacturers and suppliers.
- Evaluating alternatives and second/third sources of supply or manufacturing for core suppliers and manufacturing partners.
- Developing a clinical trial designed to test the safety and efficacy of Iomab-B.
- Working with the FDA to develop a regulatory pathway for Actimab-MDS trial.
- Seeking to effect a reverse stock split to increase the price of common stock.