Clene (CLNN) risk factors, FY2024 10-K

Risks Relating to Our Business and Industry

1. 01We depend substantially on the successful commercialization of our drug candidates in the future, which may fail to materialize or may experience significant delays
2. 02launching and commercializing any drug candidates for which we may obtain regulatory approvals and marketing authorizations, either directly or with a collaborator or distributor
3. 03We currently do not generate any revenue from the commercial sales of drug candidates and we may not become profitable when expected, or at all
4. 04We have incurred significant net losses and net operating cash outflows since our inception and expect to continue to incur significant net losses for the foreseeable future
5. 05Unstable market and economic conditions may have serious adverse consequences on our business, financial condition, results of operations, and prospects
6. 06We have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance
7. 07We may encounter difficulties in managing our growth and expanding our operations successfully, which could adversely affect our business, financial condition, results of operations, and prospects
8. 08Changes in government regulation or in practices relating to the pharmaceutical and biotechnology industries, including potential healthcare reform, could decrease the need for our drug candidates, or make it more difficult to obtain regulatory approvals for our drug candidates and commercialize them
9. 09If we, or any CRO we may 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 our business, financial condition, results of operations, and prospects
10. 10Our internal computer systems, or those used by any CROs or other third-party contractors or consultants we may engage, may fail or suffer security breaches
11. 11We manufacture all of our drug candidates ourselves, and intend to manufacture most, if not all, of any approved drugs ourselves as well, which could have a material adverse effect on our business, financial condition, results of operations, and prospects
12. 12Delays in completing and receiving regulatory approvals for our manufacturing facilities could delay our development plans or commercialization efforts, which could harm our business
13. 13ongoing compliance with GMP and other requirements of the FDA, EMA, NMPA, Health Canada, TGA or other comparable regulatory agencies
14. 14Damage to, destruction of, or interruption of production at our manufacturing facilities would negatively affect our business and prospects
15. 15Significant or sustained inflation could adversely affect our business, financial condition and results of operations
16. 16Our future success depends on our ability to retain key executives and to attract, train, retain, develop, and motivate qualified and highly skilled personnel
17. 17We benefit from certain tax and financial incentives, the expiration of or changes to which could adversely affect our profitability
18. 18Our ability to use net operating losses to offset future taxable income may be subject to certain limitations
19. 19Changes in tax laws may adversely affect us, and the Internal Revenue Service or a court may disagree with tax positions taken by us, which may result in adverse effects in our financial condition or the value of our Common Stock
20. 20Our business and operations have been affected by and could be materially and adversely affected in the future by the effects of health epidemics and pandemics, which could also cause material adverse effects on the business and operations of third parties on which we rely
21. 21The ultimate impact of potential future epidemics or pandemics is highly uncertain and subject to continued change. These effects could have a material impact on our business and operations, or the businesses and operations of third parties on which we rely
22. 22There is significant uncertainty associated with our drug candidates and their viability as a commercial product
23. 23We have not previously obtained any regulatory approval for a drug candidate and we may be unable to obtain or may be delayed in obtaining regulatory approval for any of our drug candidates
24. 24The FDA, NMPA, TGA, Health Canada, EMA or a comparable regulatory authority may require more information, including additional preclinical or clinical data, to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development program
25. 25We may not be able to successfully identify, discover, or develop new drug candidates
26. 26it may take greater human and financial resources to identify additional therapeutic opportunities for our drug candidates or to develop suitable potential drug candidates through internal research programs than we will possess, thereby limiting our ability to diversify and expand our drug portfolio
27. 27Preclinical and clinical development of drug candidates involves a lengthy and expensive process with an uncertain outcome, and we are unable to predict if or when we will successfully develop or commercialize any of our drug candidates
28. 28Results of earlier clinical trials may not be predictive of results of later-stage clinical trials
29. 29If we encounter difficulties enrolling patients in clinical trials, clinical trials of our drug candidates may be delayed or otherwise adversely affected
30. 30If we are not able to obtain, or experiences delays in obtaining, required regulatory approvals, we will not be able to commercialize our drug candidates, and our ability to generate revenue will be materially impaired
31. 31Disruptions to the normal functioning of the FDA and comparable foreign regulatory authorities and other government agencies could hinder their ability to perform and carry out important roles and activities on which the operation of our business relies, which could negatively impact our business
32. 32We do not currently have Fast Track Designation or Breakthrough Therapy Designation, but may seek one or more of such designations in the future
33. 33Although we have obtained FDA orphan drug designation for CNM-Au8 for the treatment of ALS, we may not realize any benefit from such designation and it does not increase the chance of approval
34. 34Even if we are able to commercialize any approved drug candidates, the drugs may become subject to national or other third-party reimbursement practices or unfavorable pricing regulations, which could harm our business
35. 35A primary trend in the global healthcare industry is cost containment. Government authorities and these third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications
36. 36Our drug candidates, if approved in the future, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for the drug candidate may be smaller than we estimate
37. 37the effectiveness of our sales and marketing efforts
38. 38If our drug candidates cause, or are perceived to cause, undesirable side effects, it can result in delays or failure to receive regulatory approval or limitations on the commercial profile of an approved label
39. 39Adverse drug reactions and negative results from off-label use of our products could materially harm our business reputation, product brand name, commercial operations, financial condition, including the value of our Common Stock, and expose us to liability
40. 40Off-label use of our products could expose us to government investigation or prosecution
41. 41We face substantial competition from other pharmaceutical and biotechnology companies, and our operating results may suffer if we fail to compete effectively
42. 42Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including penalties, fines and/or exclusion or suspension from federal and state healthcare programs such as Medicare and Medicaid and debarment from contracting with the U.S. government
43. 43We may face difficulties from changes to current regulations and future legislation
44. 44Any failure to perform proper quality control and quality assurance would have a material adverse effect on our business and financial results
45. 45In addition, if we fail to comply with relevant quality control requirements under laws, regulations, and GMP, we could experience a disruption in the supply of our products, which could delay or prevent further sales of such products, which could have a material adverse effect on our business and financial results
46. 46We may explore the licensing of commercialization rights or other forms of collaboration worldwide, which will expose us to additional risks
47. 47business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods, hurricanes, and fires
48. 48Illegal and/or parallel imports and counterfeit pharmaceutical products may reduce demand for our future approved drug candidates and could have a negative impact on our reputation and business
49. 49We have entered into research collaborations and may form or seek collaborations, joint ventures or strategic alliances or enter into licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances, or licensing arrangements
50. 50collaborators may own or co-own intellectual property covering our drugs that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property
51. 51Our business depends on the use of raw materials, and a decrease in the supply or an increase in the cost of these raw materials or any quality issues in such raw materials could materially and adversely affect our business, financial condition, results of operations, and prospects
52. 52We may not be able to protect our intellectual property rights throughout the world or prevent unfair competition by third parties
53. 53If we are sued for infringing the intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our drug candidates
54. 54Intellectual property litigation may lead to unfavorable publicity that harms our reputation and increases our operating losses, causing the market price of our Common Stock to decline
55. 55Obtaining 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 noncompliance with these requirements
56. 56If we do not obtain patent term extension and data exclusivity for any drug candidates we may develop, our business may be materially harmed
57. 57Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates
58. 58If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
59. 59We may be subject to claims that our employees have wrongfully used or disclosed the alleged trade secrets of their former employers
60. 60Intellectual property rights do not necessarily protect us from all potential threats to our competitive advantages

Risks Related to the Reverse Recapitalization and Integration of Businesses

1. 61We have incurred significant increased expenses and administrative burdens as a public company, which could have an adverse effect on our business, financial condition and results of operations

Risks Related to Our Common Stock

1. 62Provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our Common Stock
2. 63the requirement that a special meeting of stockholders may be called only by our Board, the chairman of our Board or our CEO, which could delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors
3. 64Future offerings of debt or equity securities by us may adversely affect the market price of our Common Stock
4. 65There can be no assurance that we will be able to comply with the continued listing requirements of Nasdaq
5. 66The price of our Common Stock may be volatile
6. 67the volume of shares of our Common Stock available for public sale; and
7. 68SEC regulations limit the amount of funds we can raise during any 12-month period pursuant to our shelf registration statement on Form S-3