Intensity Therapeutics (INTS) risk factors, FY2024 10-K

Risks Related to Our Business, Financial, and Investment Conditions

1. 01The market price of our Common Stock may be highly volatile, and you could lose all or part of your investment
2. 02We are a late-stage clinical biotechnology company with a limited operating history and have not generated any revenue to date from product sales
3. 03We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future
4. 04The report by our auditors includes a paragraph that states that substantial doubt exists about the Company’s ability to continue as a going concern
5. 05We will need to raise substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate some or all of our product development programs or commercialization efforts
6. 06We are largely dependent upon the success of our new intratumoral technology, which will require additional development before we may be able to seek regulatory approval and may never receive regulatory approval or be successfully commercialized
7. 07We have limited experience conducting cancer clinical trials, and we are subject to risks and challenges that may prevent or delay the completion of our upcoming or on-going clinical trials
8. 08We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively
9. 09Other local treatment approaches that had been explored by companies such as Merck also attempt to recruit the immune system cells into the local tumor microenvironment with intratumoral delivery of other agents
10. 10CREATES Act since its enactment, those lawsuits have settled privately; therefore, to date, no federal court has reviewed or opined on the statutory language and there continues to be uncertainty regarding the scope and application of the law
11. 11Our prospects for obtaining additional financing, as needed, are uncertain and our failure to obtain needed financing could affect our ability to pursue future growth

Risks Related to FDA and Foreign Regulatory Approval

1. 12Clinical development involves a lengthy, complex and expensive process, with an uncertain outcome, and the results of preclinical studies and early-stage clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials
2. 13We will likely need separate regulatory approvals for every therapeutic agent or combination of compounds that we intend to develop and market using our technology
3. 14Failure to obtain, or delay in obtaining, regulatory approvals would likely have a material adverse effect on our business, financial condition and results of operations
4. 15We are not permitted to market products made using our technology in the United States unless and until we obtain regulatory approval from the FDA
5. 16Delays in FDA approval could be costly to us and prevent us from commercializing our product candidates effectively
6. 17our product candidates qualify as breakthrough therapies, the FDA may later decide that the products no longer meet the conditions for qualification and rescind the breakthrough designation
7. 18If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
8. 19We will rely on third parties to conduct certain of the preclinical research and any clinical trials for products using our technology, and if those third parties perform in an unsatisfactory manner, it may harm our business
9. 20of our preclinical studies and clinical trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities
10. 21Even if products using our technology are approved by the FDA or any other regulatory agency, we will be subject to additional ongoing regulatory obligations and oversight in the U.S. and other countries where we obtain approval
11. 22Even if we obtain regulatory approval for our product candidates using our technology in the United States, our ability to market a product would be limited to those uses that are approved for that product
12. 23If we do not obtain required approvals in other countries in which we aim to market our product candidates, we will not be able to export or sell the products in those markets, which will limit our sales opportunities
13. 24If we are unable to obtain and maintain required approval from one or more foreign jurisdictions where we would like to sell products using our technology, we will be unable to market products as intended, our international market opportunity will be limited, and our results of operations will be harmed

Risks Related to Manufacturing, Commercialization, and Market Acceptance of Products made using our Technology

1. 25We intend to rely on third parties to produce clinical and commercial supplies of our product candidates
2. 26We purchase components for our product candidates from third parties, some of which may be sole-source suppliers
3. 27We have not entered into long term manufacturing and supply agreements with any producers
4. 28If we cannot successfully purchase or produce the drugs used in the manufacture of our product candidates, our ability to develop and commercialize products using our technology would be impaired
5. 29Our current and future relationships with investigators, health care professionals, consultants, third-party payors, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties
6. 30If we or any contract manufacturers and suppliers we engage 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
7. 31We have limited experience in marketing and commercializing products and, as a result, we may not be successful in commercializing products made using our technology
8. 32Even if we are successful in commercializing products using our technology in the United States, we may not be successful in other foreign countries
9. 33Our plan to use collaborative arrangements with third parties to help finance and to market and sell products using our technology may not be successful
10. 34We will be dependent on healthcare professionals’ efforts to learn about our product candidates
11. 35We may need to establish clinical training and centers of excellence to educate and train physicians and healthcare payors, but the key opinion thought leadership required for initial market acceptance within the healthcare arena may take time to develop
12. 36Healthcare legislative reform measures may have a negative impact on our business and results of operations
13. 37we fail to provide required information in a timely manner or are found to have knowingly submitted false information to CMS, we may be subject to civil monetary penalties and other sanctions, including termination from the MDRP
14. 38Medicare Part B. There can be no assurance that any future submissions we may make under such programs will not be found to be incomplete or incorrect
15. 39Rapid technological developments in treatment methods for cancer and competition with other forms of cancer treatments could affect our ability to achieve meaningful revenues or profit
16. 40The loss of key personnel could adversely affect our business
17. 41Our employees, consultants and collaborators may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements

Risks Related to Patents, Trade Secrets, and Proprietary Rights

1. 42Our success depends in part on our ability to obtain patents, maintain trade secret protection, operate without infringing on the proprietary rights of third parties, and commercialize our technology prior to the expiration of our patent protection
2. 43Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
3. 44If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed
4. 45Companies in the medical drug/device industry may use intellectual property infringement litigation to gain a competitive advantage
5. 46If a third party violates our intellectual property rights, we may be unable to enforce our rights because of our limited resources
6. 47Trade secret protection does not prevent independent discovery of the technology or proprietary information or use of the same

Risks Related to Products Liability

1. 48We may be the subject of product liability claims or product recalls, and we may be unable to maintain insurance adequate to cover potential liabilities

Risks Related to Our Securities

1. 49of our second fiscal quarter, or our annual revenues are more than $100 million during the most recently completed fiscal year and our voting and non-voting Common Stock held by non-affiliates is more than $700 million measured on the last business day of our second fiscal quarter
2. 50Substantial influence will remain with our management and major stockholder, which could delay or prevent a change of control or cause us to take actions in conflict with the intent of our stockholders
3. 51The price of our Common Stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our Common Stock
4. 52Global, market and economic conditions may negatively impact our business, financial condition and share price
5. 53Our management will have broad discretion in using the cash and cash equivalents and may not use these proceeds effectively, which could affect our results of operations and cause our stock price to decline
6. 54We do not anticipate paying dividends in the foreseeable future
7. 55Provisions in our charter documents and Delaware law may deter takeover efforts that could be beneficial to stockholder value
8. 56Our board of directors could issue additional shares of Common Stock or a new class of preferred stock and dilute the equity positions of current stockholders without consent of the investors
9. 57Our net operating loss carryforwards might not be able to be utilized in the future