Calidi Biotherapeutics (CLDI) risk factors, FY2024 10-K

Risks Related to Our Business, Financial Position and Capital Requirements

1. 01We are an immuno-oncology 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. 03We have no products approved for commercial sale and have not generated any revenue from product sales
4. 04Our engineered allogeneic stem cell and enveloped vaccina virus product candidates represent a novel approach to cancer treatment that creates significant challenges
5. 05Adverse publicity regarding stem cell-based immunotherapy could have a material adverse impact on our business
6. 06We need to raise substantial additional funding. If we are unable to raise capital when needed, or if at all, we would be forced to delay, reduce or eliminate some or all of our product development programs or cease operations altogether
7. 07We may incur significant cash payment obligations under our in-licensing agreements with Northwestern University and City of Hope

Risks Related to Product Development

1. 08Our 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
2. 09Interim, top line 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
3. 10Results of earlier studies and trials of our product candidates may not be predictive of future trial results
4. 11We may develop our product candidates in combination with other therapies, which exposes us to additional risks related to other agents or active pharmaceutical or biological ingredients used in combination with our product candidates
5. 12If the FDA or other 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
6. 13Negative developments in the field of immuno-oncology and, in particular, oncolytic viral immunotherapy, could damage public perception of any of our product candidates and negatively affect our business
7. 14Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates, and ultimately delay or prevent regulatory approval
8. 15Even 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
9. 16We 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. 17A Breakthrough Therapy designation by the FDA, even if granted for any 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
2. 18Accelerated 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
3. 19Changes in product candidate manufacturing or formulation may result in additional costs or delay
4. 20We 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 other regulatory authority may not permit us to proceed
5. 21If approved, our investigational products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway
6. 22The 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
7. 23Healthcare reform measures may have a material adverse effect on our business and results of operations
8. 24Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability
9. 25If 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
10. 26If we fail to develop additional product candidates, our commercial opportunity could be limited
11. 27We may face potential liability if we obtain identifiable patient health information from clinical trials sponsored by us
12. 28If 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
13. 29Healthcare legislative reform measures may have a negative impact on our business, financial condition, results of operations and prospects
14. 30Changes in U.S. and international trade policies may adversely impact our business and operating results
15. 31Unstable global economic and geopolitical conditions may have serious adverse consequences on our business, financial condition, stock price and results of operations

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

1. 32Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
2. 33We 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
3. 34The increasing use of social media platforms presents new risks and challenges
4. 35Our 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 security breaches, which could result in a material disruption of our product candidates’ development programs
5. 36Our operations or those of the third parties upon whom we depend might be affected by the occurrence of a natural disaster, pandemic or other catastrophic event
6. 37Recent statements and proposed action by the United States House of Representatives has been critical of the Chinese biopharmaceutical industry and may raise scrutiny as to the use of our contract manufacturer in China
7. 38Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
8. 39Our recurring losses from operations since inception and requirement for additional funding to finance our operations raise substantial doubt about our ability to continue as a going concern

Risks Related to Legal and Compliance Matters

1. 40We 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. 41If 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
3. 42Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition
4. 43Our employees, independent contractors, consultants, commercial partners, principal investigators or CROs 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
5. 44Violations 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. 45If 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
2. 46Conflicts with our development and commercialization collaborators or licensors could materially adversely affect our business, financial condition or results of operations and future growth prospects
3. 47Our 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. 48Our 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
2. 49We 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
3. 50We 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
4. 51If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
5. 52Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts
6. 53Our 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
7. 54Third parties may assert that we are employing their proprietary technology without authorization
8. 55Third 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
9. 56Because 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
10. 57We 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
11. 58Obtaining 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
12. 59Any issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO
13. 60Changes in patent law in the U.S. and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
14. 61We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world
15. 62Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
16. 63If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed
17. 64If 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 Ownership of Our Common Stock

1. 65We have insufficient cash to continue our operations for the next 12 months and our continued operations are dependent on us raising capital and these conditions give rise to substantial doubt over the Company’s ability to continue as a going concern
2. 66The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business
3. 67Sales and issuances of our common stock or other securities could result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall
4. 68If we fail to comply with the continued listing standards of the NYSE American, our common stock could be delisted. If it is delisted, the market value and the liquidity of our common stock would be impacted
5. 69Because the Trading Price of our Common Stock has decreased, it is unlikely that we will receive any Settlement Amount Under the Forward Purchase Agreements