Candel Therapeutics (CADL) risk factors, FY2024 10-K

Risks Related to Our Business, Financial Position and Capital Requirements

1. 01We are a biopharmaceutical company with a limited operating history and have not generated any revenue to date from product sales
2. 02We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future
3. 03The amount of our future losses is uncertain, and our quarterly and annual operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline
4. 04future accounting pronouncements or changes in our accounting policies
5. 05We have no products approved for commercial sale and have not generated any revenue from product sales
6. 06hire additional staff, including clinical, scientific and management personnel
7. 07We will need to raise substantial additional funding, which may not be available on acceptable terms, or at all. If we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts or initiate steps to cease operations
8. 08the impact of any future public health crisis, which may exacerbate the magnitude of the factors discussed above
9. 09Any future corporate restructuring and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business
10. 10We have incurred indebtedness, and we may incur additional indebtedness, which could adversely affect our financial condition
11. 11limits our ability to obtain additional financing or refinancing in the future for working capital, clinical trials, research and development, or other purposes
12. 12Termination of cash management arrangements and/or delays in accessing or actual loss of funds subject to cash management arrangements

Risks Related to Product Development

1. 13We currently have no products that are approved for commercial sale and may never be able to develop marketable products. We expect that a substantial portion of our efforts and expenditures over the next several years will be devoted to our CAN-2409 program, which is currently our most advanced product candidate
2. 14future product candidate do not receive regulatory approval or fail to achieve significant market acceptance, we would be delayed by many years in our ability to achieve profitability, if ever
3. 15Our preclinical studies and clinical trials may fail to demonstrate adequately the safety and efficacy of any of our product candidates, which would prevent or delay development, regulatory approval, and commercialization
4. 16Interim, topline and preliminary 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 regulatory audit and verification procedures that could result in material changes in the final data
5. 17We may not be successful in our efforts to identify additional product candidates or indications. Due to our limited resources and access to capital, we must prioritize development of certain product candidates and indications; these decisions may prove to be wrong and may adversely affect our business
6. 18it may take greater human and financial resources than we possess to identify additional therapeutic opportunities for our product candidates or to develop suitable potential product candidates through internal research programs, thereby limiting our ability to develop, diversify and expand our product portfolio
7. 19Results of earlier studies and trials of our product candidates may not be predictive of future trial results
8. 20We have concentrated our research and development efforts on our CAN-2409 and CAN-3110 product candidates, and our future success largely depends on the successful development of these therapeutic approaches
9. 21We are developing, and in the future may develop, other product candidates, in combination with other therapies, which exposes us to additional risks related to any prodrugs or any agents used in combination with our product candidates
10. 22If the FDA or comparable foreign regulatory authorities revoke their approval of these other drugs or revoke their approval of, or if safety, efficacy, manufacturing or supply issues arise with, the drugs we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval
11. 23Negative developments in the field of immuno-oncology and, in particular, viral immunotherapy, could damage public perception of any of our product candidates and negatively affect our business
12. 24Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates, and ultimately delay or prevent regulatory approval
13. 25factors we may not be able to control, such as any future public health crisis, that may limit patient participation, hiring of principal investigators or staff or clinical site availability
14. 26Even if we receive marketing approval for our current or future product candidates, our current or future product candidates may not achieve broad market acceptance, which would limit the revenue that we generate from their sales
15. 27potential product liability claims
16. 28We face substantial competition, which may result in others discovering, developing or commercializing product candidates before or more successfully than we do

Risks Related to Government Regulation and Commercialization of Our Product Candidates

1. 29FDA’s or a comparable foreign regulatory authority’s requests for additional data or information could also result in substantial delays in the approval of CAN-2409, CAN-3110 and future product candidates
2. 30Moreover, if the FDA revokes or alters its agreement under the SPA, or interprets the data collected from the clinical trial differently than we do, the FDA may not deem the data sufficient to support an application for regulatory approval of CAN-2409 in prostate cancer
3. 31A breakthrough therapy designation by the FDA, even if granted for some indications of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval for the designated indications
4. 32Accelerated approval by the FDA, even if granted for certain of our current or future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval
5. 33contain requirements for costly post-market testing and surveillance, or other requirements, including the submission of a REMS, to monitor the safety or efficacy of the products
6. 34Changes in product candidate manufacturing or formulation may result in additional costs or delay
7. 35Even if CAN-2409, CAN-3110 or any future product candidates receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense and limit how we manufacture and market our products
8. 36injunctions or the imposition of civil, criminal or administrative penalties, including imprisonment
9. 37We may not be able to file INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA or a comparable foreign regulatory authority may not permit us to proceed
10. 38If approved, our investigational products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway
11. 39The size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates
12. 40Healthcare reform measures may have a material adverse effect on our business and results of operations
13. 41the availability of capital
14. 42unforeseen costs and expenses associated with creating an independent sales and marketing organization
15. 43If any product candidate for which we receive regulatory approval does not achieve broad market acceptance among physicians, patients, healthcare payors, and the medical community, the revenues that we generate from its sales will be limited
16. 44favorable or unfavorable publicity relating to the product or relating to the Company
17. 45If we fail to develop additional product candidates, our commercial opportunity could be limited
18. 46subject to the risks of failure inherent in medical product development. We cannot assure you that we will be able to successfully advance any of these additional product candidates through the development process
19. 47We may face potential liability if we obtain identifiable patient health information from clinical trials sponsored by us
20. 48Foreign data protection laws, including the European Union’s General Data Protection Regulation (the EU GDPR), and the United Kingdom (or UK) equivalent of the same (the UK GDPR, together with the EU GDPR, the GDPR) may also apply to our processing of health-related and other personal data
21. 49Additionally, we are subject to other state and foreign equivalents of each of the healthcare laws described above, among others, some of which may be broader in scope and may apply regardless of the payor
22. 50If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business

Risks Related to Employee Matters, Managing Growth and General Business Operations

1. 51CDMOs, researchers and investigators, regulatory agency personnel and logistics providers, all of which may in the future be adversely affected by any future public health crisis
2. 52Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
3. 53We expect to expand our development, manufacturing and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
4. 54The increasing use of social media platforms presents new risks and challenges
5. 55Our internal computer systems, or those of our third-party CROs that we may use in the future, or other contractors or consultants, may fail or suffer cybersecurity incidents or data breaches, which could result in a material disruption of our product candidates’ development programs
6. 56Our operations or those of the third parties upon whom we depend might be affected by the occurrence of a natural disaster, pandemic, war or other catastrophic event
7. 57Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
8. 58periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in our financial reporting, and the market price of our common stock may decline as a result

Risks Related to Legal and Compliance Matters

1. 59We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability and have to limit the commercialization of any approved products and/or our product candidates
2. 60product recalls, withdrawals or labeling, marketing or promotional restrictions, including withdrawal of marketing approval
3. 61If 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, stock price and prospects will be materially harmed
4. 62Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition
5. 63Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
6. 64Our employees, independent contractors, consultants, commercial partners, principal investigators, CROs or CDMOs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could have a material adverse effect on our business
7. 65Violations of, or liabilities under, environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have a material adverse effect on the success of our business

Risks Related to Our Reliance on Third Parties

1. 66by collaborators, or caused by other collaboration contract obligations, may result in a delay of our ability to disclose data
2. 67collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation
3. 68If conflicts arise with our development and commercialization collaborators or licensors, they may act in their own self-interest, which may be adverse to the interests of our company
4. 69Conflicts with our development and commercialization collaborators or licensors could materially adversely affect our business, financial condition or results of operations and future growth prospects
5. 70obtain, or may be delayed in obtaining, marketing approvals for our product candidates. If that occurs, we will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates
6. 71We have completed and may in the future complete related party transactions that were not and may not be conducted on an arm’s length basis
7. 72Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed

Risks Related to Intellectual Property

1. 73the priority of invention of patented technology
2. 74the affected product candidates and technology. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects
3. 75Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection
4. 76We cannot be certain that we were the first to file any patent application related to our technology and directed to our product candidates, and, if we were not, we may be precluded from obtaining patent protection for our technology, including our product candidates
5. 77We may enter into license or other collaboration agreements in the future that may impose certain obligations on us. If we fail to comply with our obligations under such future agreements with third parties, we could lose license rights that may be important to our future business
6. 78If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
7. 79Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts
8. 80redesigning our product candidates or processes so they do not infringe, which may not be possible or may require substantial monetary expenditures and time
9. 81Our collaborators may assert ownership or commercial rights to inventions they develop from research we support or that we develop from our use of the tissue samples or other biological materials, which they provide to us, or otherwise arising from the collaboration
10. 82Third parties may assert that we are employing their proprietary technology without authorization
11. 83Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information, misappropriated trade secrets, or are in breach of non-competition or non-solicitation agreements with our competitors
12. 84Because our programs may involve additional product candidates that may require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license or use these proprietary rights
13. 85We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful
14. 86Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
15. 87Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO or could expire before the first product achieves marketing approval
16. 88We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world
17. 89Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
18. 90If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed
19. 91If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected

Risks Related to Our Common Stock

1. 92The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses to stockholders
2. 93the other factors described in this “Risk Factors” section
3. 94ourselves of reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies, which could make our common stock less attractive to investors and adversely affect the market price of our common stock
4. 95exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved
5. 96We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices
6. 97If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our common stock could decline. As of March 6, 2025, we had a total of 47,235,460 shares of common stock outstanding
7. 98Because 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
8. 99Our executive officers, directors, principal stockholders and their affiliates exercise significant influence over our company, which will limit your ability to influence corporate matters and could delay or prevent a change in corporate control
9. 100Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control, which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management
10. 101the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval and which preferred stock may include rights superior to the rights of the holders of common stock
11. 102Our bylaws designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees
12. 103If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline
13. 104We may be subject to securities litigation, which is expensive and could divert management's attention
14. 105as a result of our December 2024 issuance of pre-funded warrants to purchase up to an aggregate of 3,333,333 shares of common stock
15. 106an additional 918,121 shares vest upon (1) a financing event with a per share price of $14.68, or (2) an average market price (determined over a consecutive 10-day period) of, $14.68 per share