Cypherpunk Technologies (CYPH) risk factors, FY2024 10-K

Risks Related to Leap’s Financial Position and Capital Needs

1. 01We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future
2. 02As a result, we have not been profitable to date and have incurred losses in every reporting period since our inception in 2011. For the year ended December 31, 2024, we reported a net loss of $67.6 million and had an accumulated deficit of $467.4 million at December 31, 2024
3. 03We currently have no source of product revenue and may never become profitable
4. 04Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates

Risks Related to Our Business and Industry

1. 05Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process
2. 06commercialization of that product candidate. Any of these scenarios could compromise the commercial prospects for our product candidates
3. 07If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of clinical data and necessary regulatory approvals could be delayed or prevented
4. 08Our inability to enroll and maintain a sufficient number of patients for our clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether
5. 09Interim, “top-line” or preliminary data from studies or trials announced or published from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data
6. 10The FDA may determine that any of our current or future product candidates have undesirable side effects that could delay or prevent their regulatory approval or commercialization

Risks Related to the Development and Commercialization of Our Product Candidates

1. 11Our clinical development program was restructured following the results of the data received for our gastric cancer program, and we cannot guarantee that our redirected focus on colorectal cancer and FL-501 will be successful
2. 12growth and differentiation factor 15 (GDF-15) protein. This strategic realignment represents a significant change in our clinical development pipeline and priorities
3. 13The therapeutic safety and efficacy of sirexatamab is unproven, and we may not be able to successfully develop and commercialize any of our products
4. 14Our future success is heavily dependent on the success of sirexatamab
5. 15We face substantial competition from much larger competitors, which may result in others discovering, developing or commercializing products before, or more successfully than, we do
6. 16We may acquire other assets, form collaborations or make investments in other companies or technologies, that could harm our operating results, dilute our stockholders’ ownership, or cause us to incur significant expense

Risks Related to Our Dependence on Third Parties

1. 17We depend on information technology and a failure of, or significant disruption to, those systems could have a material adverse effect on our business and operations

Risks Related to Legal and Compliance Matters

1. 18If we fail to comply with federal and state healthcare laws, including fraud and abuse and health and other information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, and prospects could be adversely affected

Risks Related to Our Intellectual Property

1. 19If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate to protect our technology and product candidates, our competitive position could be harmed
2. 20of a therapeutic antibody and not limited by an amino acid sequence, we cannot be certain that we will be able to successfully enforce those patents against our competitors with antibodies to these targets

Risks Related to our Common Stock

1. 21Our share price has been low and volatile. If our share price continues to be low and volatile, we could be subject to securities class action litigation and our stockholders could incur substantial losses
2. 22We are a “smaller reporting company,” and we take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our common stock being less attractive to investors
3. 23Our business is subject to changing regulations for corporate governance and public disclosure that has increased both our costs and the risk of noncompliance
4. 24Sales of a substantial number of shares of our common stock in the public market by our stockholders could cause our stock price to fall
5. 25Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain
6. 26Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our Common Stock