Immix Biopharma (IMMX) risk factors, FY2025 10-K

Risks Relating to Our Financial Position and Capital Needs

1. 01We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the foreseeable future22% rewritten
2. 02We need significant additional financing to fund our operations and complete the development and, if approved, the commercialization of our product candidates. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts23% rewritten
3. 03Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms to us
4. 04We currently have no source of revenues. We may never generate revenues or achieve profitability
5. 05Our ability to use net operating losses to offset future taxable income may be subject to limitations
6. 06Economic uncertainty may affect our access to capital and/or increase the costs of such capital
7. 07The pausing or termination of government grants by the United States government could have a major effect on the pharmaceutical industry, and as a result, our operations and prospects
8. 08A shutdown of the U.S. federal government may adversely affect our businessNew
9. 09We may not receive the remaining $1.8 million of the $8 million which we learned was granted to us by the California Institute for Regenerative Medicine40% rewritten

Risks Relating to the Development and Regulatory Approval of Our Product Candidates

1. 10We have a limited number of product candidates, all which are still in early clinical or pre-clinical development. If we do not obtain regulatory approval of one or more of our product candidates, or experience significant delays in doing so, our business will be materially adversely affected
2. 11If clinical trials for our product candidates are prolonged, delayed or stopped, we may be unable to obtain regulatory approval and commercialize our product candidates on a timely basis, or at all, which would require us to incur additional costs and delay our receipt of any product revenue
3. 12The design or our execution of clinical trials may not support regulatory approval
4. 13We may find it difficult to enroll patients in our clinical trials given the limited number of patients who have the diseases for which our product candidates are being studied which could delay or prevent the start of clinical trials for our product candidates
5. 14In general, CAR-T cell therapy has historically been associated with serious toxicitiesNew
6. 15We are dependent on third parties for manufacturing and marketing of our product candidates. If we are not able to secure favorable arrangements with such third parties, our business and financial condition could be harmed
7. 16In the event that we need to change our CMOs, our pre-clinical studies, clinical trials or the commercialization of our product candidates could be delayed, adversely affected or terminated, or such a change may result in significantly higher costs
8. 17We may have conflicts with our future partners that could delay or prevent the development or commercialization of our product candidates
9. 18We may not be able to conduct, or contract others to conduct, animal testing in the future, which could harm our research and development activities
10. 19If any of our product candidates receive regulatory approval, the approved products may not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, in which case revenue generated from their sales would be limited
11. 20Even if we receive regulatory approval to commercialize any of the product candidates that we develop, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense
12. 21If any product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
13. 22Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain for such product candidates
14. 23If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected
15. 24The laws to which we will be subject and which could impact our business activities include the following
16. 25If we are unable to effectively adapt to changes in the healthcare industry, our business may be harmed

Risks Relating to our Business and Operations

1. 26We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success
2. 27If the market opportunities for our current and potential future product candidates are smaller than we believe they are, our ability to generate product revenue may be adversely affected and our business may suffer
3. 28Our products will face significant competition, and if they are unable to compete successfully, our business will suffer
4. 29Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or protected health information or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation
5. 30Use of artificial intelligence in research, development, and commercial activities presents operational, regulatory, ethical, and reputational risks that could adversely affect our businessNew
6. 31Unfavorable geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations
7. 32Any international operations we undertake may subject us to risks inherent with operations outside of the United States
8. 33We may not be successful in hiring and retaining key employees, including executive officers
9. 34Our employees, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
10. 35California’s climate-disclosure laws may impose significant compliance burdens, create operational disruptions, and divert resources critical to the advancement of our clinical programsNew

Risks Relating to our Intellectual Property

1. 36It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position does not adequately protect our product candidates, others could compete against us, which may have a material adverse effect on our business
2. 37If we fail to comply with our obligations in the agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our potential licensors, we could lose rights that are important to our business
3. 38If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our future licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize our product candidates
4. 39We may incur substantial costs as a result of litigation or other proceedings relating to patents and other intellectual property rights
5. 40We may infringe on the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product candidates
6. 41If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be significantly diminished
7. 42We may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets
8. 43Our intellectual property may not be sufficient to protect our product candidates from competition, which may negatively affect our business
9. 44Intellectual property rights and enforcement may be less extensive in jurisdictions outside of the U.S.; thus, we may not be able to protect our intellectual property and third parties may be able to market competitive products that may use some or all of our intellectual property
10. 45We conduct certain research and development operations through our Australian wholly-owned subsidiary. If we lose our ability to operate in Australia, or if our subsidiary is unable to receive the research and development tax credit allowed by Australian regulations, our business and results of operations could suffer
11. 46Orphan Drug Designation does not translate to approval and, even if we obtain FDA approval, we may not enjoy marketing exclusivity or other expected benefitsNew

Risks Related to Owning our Common Stock

1. 47The price of our common stock may fluctuate substantially
2. 48Because certain of our stockholders control a significant number of shares of our common stock, they may have effective control over actions requiring stockholder approval
3. 49We do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares
4. 50Market and economic conditions may negatively impact our business, financial condition and share price
5. 51If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline
6. 52Future sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall. In addition, the perception that sales of our common stock could occur, could cause our stock price to fall
7. 53The number of shares of our common stock available for future issuance or sale could adversely affect the per share trading price of our common stock
8. 54We are an “emerging growth company” and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our common stock less attractive to investors. In addition, as a smaller reporting company we will also have reduced disclosure requirements36% rewritten
9. 55We may be at risk of securities class action litigation
10. 56Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters