Actinium Pharmaceuticals (ATNM) risk factors, FY2024 10-K

Risks Related to Our Business

1. 01We are a clinical-stage company and have generated no revenue from commercial sales to date
2. 02We have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future
3. 03As of the date of filing this report, we expect that our existing resources will be sufficient to fund our planned operations for more than 12 months following the date of this report
4. 04We have limited access to the capital markets and even if we can raise additional funding, we may be required to do so on unfavorable terms
5. 05None of the drug candidates we are developing, or have developed, have received regulatory approval. Based on the current status of our pipeline candidates, it will likely take several years or additional clinical studies before we can seek approval for any drug candidate
6. 06We may be unable to establish sales, marketing and commercial supply capabilities
7. 07Our business could be adversely affected by the effects of future health epidemics
8. 08Our business is subject to cybersecurity risks

Risks Related to Regulation

1. 09The FDA, EMA or comparable foreign regulatory authorities may disagree with our regulatory plans and we may fail to obtain regulatory approval of our product candidates
2. 10We are also evaluating Iomab-ACT, which uses a lower dose I-131 for conditioning prior to cellular therapies such as CAR-T and gene therapies. We are currently studying Iomab-ACT in three clinical trials including two investigator sponsored studies
3. 11We have not demonstrated that any of our products are safe and effective for any indication and will continue to expend substantial time and resources on clinical development before any of our current or future product candidates will be eligible for FDA approval, if ever
4. 12Post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up
5. 13We may encounter substantial delays in our clinical trials or may not be able to conduct our trials on the timelines we expect
6. 14Modifications to our product candidates may require federal approvals
7. 15Clinical trials necessary to support approval of our product candidates are time-consuming and expensive
8. 16Preliminary, Interim, and “top-line” data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
9. 17Our clinical trials may fail to demonstrate adequately the efficacy and safety of our product candidates, which would prevent or delay regulatory approval and commercialization
10. 18The intellectual property related to antibodies we have licensed has expired or likely expired
11. 19Our Actimab-A program clinical trials are testing the same drug construct
12. 20We are currently developing, and in the future may develop, product candidates in combination with other therapies and that may expose us to additional risks
13. 21We may be unable to obtain a sufficient supply of isotopes to support clinical development or at commercial scale
14. 22If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
15. 23FDA may take actions that would prolong, delay, suspend, or terminate clinical trials of our product candidates, which may delay or prevent us from commercializing our product candidates on a timely basis
16. 24Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review
17. 25Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates which could limit our sales of our product candidates, if approved
18. 26Healthcare legislative reform measures intended to increase pressure to reduce prices of pharmaceutical products paid for by Medicare or, otherwise, affect the federal regulation of the U.S. healthcare system could have a material adverse effect our business, future revenue, if any, and results of operations
19. 27Changes in the healthcare industry and in healthcare spending could adversely affect our grant funded clinical programs, business, financial condition and results of operations
20. 28Third-party payors may not adequately reimburse customers for any product candidates that we may commercialize or promote, and may impose coverage restrictions or limitations such as prior authorizations and step edits that affect their use

Risks Related to Third Parties

1. 29We may rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates
2. 30The protection against generic competition for our biologic drug candidates and reimbursement by CMS may be subject to future change
3. 31Our product candidates may never achieve market acceptance
4. 32We may be subject to claims that our third-party service providers, consultants or current or former employees have wrongfully used or disclosed confidential information of third parties
5. 33We currently depend on single third-party manufacturers to produce our pre-clinical and clinical trial drug supplies. Any disruption in the operations of our current third-party manufacturers, or other third-party manufacturers we may engage in the future, could adversely affect our business and results of operations
6. 34If we are successful in obtaining marketing approval from the FDA and/or other regulatory agencies for any of our product candidates, we anticipate continued reliance on third-party manufacturers
7. 35We may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates
8. 36If in the future we are unable to establish U.S. or global sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates, we may not be successful in commercializing our product candidates if they are approved and we may not be able to generate any revenue
9. 37We face significant competition from other biotechnology and pharmaceutical companies
10. 38Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences

Risks Related to Our Intellectual Property

1. 39We depend upon securing and protecting critical intellectual property
2. 40Our patent position is highly uncertain and involves complex legal and factual questions
3. 41As a result, our owned and licensed patents may not be valid, and we may not be able to obtain and enforce patents and to maintain trade secret protection for the full commercial extent of our technology. The extent to which we are unable to do so could materially harm our business
4. 42If we are found to be infringing patents or trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license to continue the development or sale of our products, and/or pay damages
5. 43Our ability to protect and enforce our patents does not guarantee that we will secure the right to commercialize our potential products and respective patents
6. 44We rely on confidentiality agreements to protect our trade secrets. If these agreements are breached by our employees or other parties, our trade secrets may become known to our competitors
7. 45We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers
8. 46Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of non-compliance with these requirements

Risks Related to Our Operations

1. 47We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy
2. 48Managing our growth as we expand operations may strain our resources
3. 49The use of hazardous materials, including radioactive and biological materials, in our research and development efforts imposes certain compliance costs on us and may subject us to liability for claims arising from the use or misuse of these materials
4. 50We may undertake international operations, which will subject us to risks inherent with operations outside of the United States
5. 51We expect to experience growth in the number of our employees and the scope of our operations, particularly in the areas of product candidate development, regulatory affairs and, if any of our product candidates receives marketing approval, sales, marketing, and distribution
6. 52We continuously evaluate our business strategy and may modify our strategy as necessary to respond to developments in our business and other factors, and any such modification, if not successful, could have a material adverse effect on our business, financial condition, and results of operations
7. 53We may expand our business through the acquisition of rights to new product candidates that could disrupt our business, harm our financial condition and may also dilute current stockholders’ ownership interests in our company

Risks Related to Ownership of Our Common Stock

1. 54The sale of securities by us in any equity or debt financing could result in dilution to our existing stockholders and have a material adverse effect on our earnings
2. 55We have financed our operations primarily through sales of stock and warrants. It is likely that during the next twelve months we will seek to raise additional capital through the sales of stock and warrants in order to expand our level of operations to continue our research and development efforts
3. 56Our common stock is subject to price volatility which could lead to losses by stockholders and potential costly security litigation
4. 57We do not intend to pay dividends on our common stock, so any returns will be determined by the value of our common stock
5. 58Certain provisions of our Certificate of Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us and make a takeover more difficult to complete, even if such a transaction were in our stockholders’ interest
6. 59We face risks associated with litigation and claims
7. 60Compliance with the reporting requirements of federal securities laws can be expensive
8. 61Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
9. 62Failure to establish and maintain adequate finance infrastructure and accounting systems and controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies
10. 63If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the price of our common stock and trading volume could decline
11. 64Our amended and restated bylaws, as amended, designate the U.S. federal district courts as the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended
12. 65Tariff policies and potential countermeasures could increase our costs and disrupt our global supply chain, which could negatively impact the results of our operations