Lantern Pharma (LTRN) risk factors, FY2025 10-K

Risks Related to Financial Position and Need for Capital

1. 01We will need substantial additional funding in the near future, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our drug development programs or commercialization efforts
2. 02The report of our independent registered public accounting firm contained elsewhere in this report states that substantial doubt exists about the Company’s ability to continue as a going concern in the absence of obtaining substantial additional fundingNew
3. 03We have a limited operating history and have never generated any revenues other than from research grants, which may make it difficult to evaluate the success of our business to date and to assess our future viability
4. 04We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability

Risks Related to the Discovery and Development of Drug Candidates

1. 05Change in priorities at the FDA and other government agencies could hinder our ability to develop and commercialize any of our product candidates in a timely manner
2. 06We have limited experience in drug discovery and drug development and may not receive regulatory approval to market our drug candidates
3. 07Delays in clinical testing could result in increased costs to us and delay our ability to generate revenue
4. 08Our drug candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any
5. 09Our RADR ® platform may fail to help us discover and develop additional potential drug candidates
6. 10Any failure by us to comply with existing regulations could harm our reputation and operating results
7. 11We may be subject to extensive regulations outside the United States and may not obtain marketing approvals for drugs in Europe and other jurisdictions
8. 12If we are found in violation of federal or state “fraud and abuse” laws, we may be required to pay a penalty and/or be suspended from participation in federal or state health care programs, which may adversely affect our business, financial condition and results of operations
9. 13Our inability to obtain and retain sufficient clinical trial liability insurance at an acceptable cost to protect against potential liability claims could prevent or inhibit our ability to conduct clinical trials for drug candidates we develop
10. 14The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses
11. 15We may not experience a faster development or regulatory review or approval process with potential Fast Track designation

Risks Related to Commercialization of Our Drug Candidates

1. 16Even if we are successful in completing all preclinical studies and clinical trials, we may not be successful in commercializing one or more of our drug candidates
2. 17If our drugs do not gain market acceptance, our business will suffer because we might not be able to fund future operations
3. 18We may rely on orphan drug status to commercialize some of our drug candidates, and even if orphan drug status is approved, such approval may not confer marketing exclusivity or other commercial advantages or expected commercial benefits
4. 19A breakthrough therapy designation by the FDA for our drug candidates may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our drug candidates will receive marketing approval
5. 20A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process
6. 21Failure to obtain marketing approval in foreign jurisdictions would prevent our drug candidates from being marketed abroad
7. 22We operate in a highly competitive and rapidly changing industry
8. 23If we are unable to develop satisfactory sales and marketing capabilities, we may not succeed in commercializing LP-300, LP-184, LP-284 or any other drug candidate
9. 24Even if we obtain regulatory approvals to commercialize LP-300, LP-184, LP-284 or our other drug candidates, our drug candidates may not be accepted by physicians or the medical community in general
10. 25Healthcare reform measures could hinder or prevent our drug candidates’ commercial success
11. 26Currently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and affect the prices we may obtain for any drugs that are approved in the United States or foreign jurisdictions
12. 27Governments outside of the United States tend to impose strict price controls, which may adversely affect our revenues, if any
13. 28If we or any third-party manufacturers or contractors we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could harm our business
14. 29We may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our RADR ® platform

Risks Related to Our Reliance on Third Parties

1. 30We, or third-party manufacturers on whom we rely, may be unable to successfully scale-up manufacturing of our drug candidates in sufficient quality and quantity, which would delay or prevent us from developing our drug candidates and commercializing approved drugs, if any
2. 31Our failure to find third party collaborators to assist or share in the costs of drug development could materially harm our business, financial condition and results of operations
3. 32Cash balances held at banking institutions may be in excess of FDIC coverage34% rewritten

Risks Related to Our Business and Industry

1. 33We will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties in managing growth
2. 34We depend on our senior management team, and the loss of one or more of our executive officers or key employees or an inability to attract and retain highly skilled employees could adversely affect our business
3. 35Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading
4. 36Business interruptions could adversely affect future operations, revenues, and financial conditions, and may increase our costs and expenses
5. 37Disruptions to our information technology systems, including future cyber-attacks and security breaches, and the costs of maintaining secure and effective information technology systems could negatively affect our business and results of operations
6. 38Unfavorable geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations21% rewritten
7. 39Our failure to successfully acquire, develop and market additional drug candidates could impair our ability to grow
8. 40We have obtained statistical data, market data and other industry data and forecasts used throughout this report from market research, publicly available information and industry publications which we believe are reliable but have not been verified by any third party

Risks Related to Our Intellectual Property

1. 41If we do not obtain patent term extension for any drug candidates we may develop, our business may be materially harmed
2. 42Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our drugs
3. 43We or our licensors may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful
4. 44Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business
5. 45Intellectual property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract our personnel from their normal responsibilities
6. 46Obtaining and maintaining 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
7. 47If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business
8. 48We may not be able to protect our intellectual property and proprietary rights throughout the world
9. 49Intellectual property rights do not necessarily address all potential threats

Risks Related to Owning our Common Stock

1. 50Our stock price has been volatile and thinly traded which may impair your ability to sell your shares
2. 51Shares eligible for future sale may adversely affect the market for our common stock
3. 52The price of our common stock may fluctuate substantially
4. 53We have broad discretion in the use of our financial resources and may not use them effectively
5. 54We may acquire other companies or technologies, which could divert our management’s attention, result in dilution to our stockholders and otherwise disrupt our operations and adversely affect our operating results
6. 55Market and economic conditions, including inflation and changes in interest rates, may negatively impact our business, financial condition and share price
7. 56If 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
8. 57Because certain of our stockholders control a significant number of shares of our common stock, they may have effective control over actions requiring stockholder approval
9. 58Future 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 fall39% rewritten
10. 59We do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our sharesNew
11. 60We may be at risk of securities class action litigation
12. 61Our certificate of incorporation and our by-laws, and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline
13. 62Financial reporting obligations of being a public company in the United States require well defined disclosure and financial controls and procedures that are expensive and time-consuming requiring our management to devote substantial time to compliance matters
14. 63Comprehensive tax reform bills could adversely affect our business and financial condition