Cerenome (CNSY) risk factors, FY2025 10-K

Risks Related to our Financial Position and Capital Requirements

1. 01We have incurred losses since inception, we expect to incur significant net losses in the foreseeable future and we may never become profitable and our operating results have been and will likely continue to be volatile
2. 02our success at commercializing our CNSideTM Portfolio
3. 03Uncertainties relating to our ability to fund our operations raises substantial doubt about our ability to continue as a going concern76% rewritten
4. 04arrangements with collaborative partners or otherwise that may require us to relinquish rights to some of our intellectual property or product candidates or otherwise agree to terms unfavorable to usNew
5. 05We could be delisted from Nasdaq for failure to comply with the Minimum Stockholders’ Equity Requirement, the Minimum Bid Requirement or other applicable continued listing requirements and standards of Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital94% rewritten
6. 06Minimum Stockholders’ Equity RequirementNew
7. 07On November 13, 2025, we received a second letter from the Nasdaq Staff advising that we had been granted an additional 180 calendar days, or until May 11, 2026, to regain compliance with the Minimum Bid Requirement, in accordance with Nasdaq Listing Rule 5810(c)(3)(A)New
8. 08Potential Consequences of DelistingNew
9. 09the incurring of additional costs under state blue sky laws in connection with any sales of our securitiesNew
10. 10The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts
11. 11We maintain our cash at financial institutions, often in balances that exceed federally insured limits93% rewritten
12. 12Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited

Risks Related to Our Business and Industry

1. 13If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired52% rewritten
2. 14Our future success is in large part dependent upon our ability to successfully develop our nanomedicine platform and commercialize rhenium (186Re) obisbemeda and 188RNL-BAM and any failure to do so could significantly harm our business and prospects42% rewritten
3. 15188RNL-BAM was developed and tested preclinically as a drug product. The FDA has informed us that 188RNL-BAM will, moving forward, be regulated instead as a medical device33% rewritten
4. 16We recently acquired the CNSide Portfolio, and we may not be successful in our efforts to develop, fully utilize and monetize it99% rewritten
5. 17Clinical Laboratory Association and the other by the Association for Molecular Pathology— were filed in federal district courts in Texas in 2024 and were subsequently consolidatedNew
6. 18the ease of use of our ordering process for healthcare providersNew
7. 19If we are unable to successfully partner with other companies to commercialize our product candidates, our business could materially suffer
8. 20Our success depends in substantial part on our ability to obtain regulatory clearance, authorization or approval for our RNL product candidates. However, we cannot be certain that we will receive regulatory clearance, authorization or approval for these product candidates or our other product candidates25% rewritten
9. 21If we or any party to a key collaboration, licensing, development, acquisition or similar arrangement fail to perform material obligations, or commit a breach, under such arrangement, or any arrangement is terminated for any reason, there could be an adverse effect on our business
10. 22whether and the extent to which inventors are able to contest the assignment of their rights to our licensors
11. 23Our current business strategy is high-risk and may not be successful
12. 24Reliance on government funding for our programs may impose requirements that limit our ability to take certain actions, and subject it to potential financial penalties, which could materially and adversely affect our business, financial condition and results of operations
13. 25The DoD Award is dependent on continued U.S. government funding and government appropriations, which may not be forthcoming on a timely basis or at all
14. 26If our competitors market or develop products that are marketed more effectively, approved more quickly than our product candidates, or demonstrated to be safer or more effective than our product candidates, our commercial opportunities could be reduced or eliminated
15. 27resources, experience and expertise in prosecution and enforcement of intellectual property rights
16. 28Product development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
17. 29a regulatory agency may put a clinical study on hold pending additional safety data (and there can be no assurance that we will be able to satisfy the regulator agencies’ requests in a timely manner, which can lead to significant uncertainty in the completion of a clinical study)
18. 30Preclinical studies and preliminary and interim data from clinical trials of our product candidates are not necessarily predictive of the results or success of ongoing or future clinical trials of our product candidates
19. 31Because we have limited resources, we may decide to pursue a particular product candidate and fail to advance product candidates that later demonstrate a greater chance of clinical and commercial success
20. 32Clinical trial results may fail to support approval of our product candidates
21. 33If third parties we engage are not able to successfully perform, we may not be able to successfully complete clinical development, obtain regulatory approval or commercialize our product candidates and our business could be substantially harmed
22. 34a third-party manufacturer may gain knowledge from working with us that could be used to supply one of our competitors with a product that competes with ours
23. 35We may have difficulty enrolling, or fail to enroll patients, in our clinical trials, which could delay or prevent clinical trials of our drug candidates
24. 36If a particular product candidate causes significant adverse events, then we may be unable to receive regulatory approval or market acceptance for such product candidate
25. 37If our product candidates and technologies receive regulatory approval but do not achieve broad market acceptance, especially by physicians, the revenue that we generate will be limited
26. 38pricing and cost effectiveness
27. 39All potential applications of our product candidates are investigational, which subjects us to development and marketing risks
28. 40The worldwide regulatory process for our nanomedicine drug candidates can be lengthy and expensive, with no guarantee of approval44% rewritten
29. 41We will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant expense, and if we or our collaborators fail to comply with such requirements, regulatory agencies may take action against us or them, which could significantly harm our business
30. 42The future regulatory processes that will be applicable to LDTs are uncertain and may prevent us from obtaining required authorizations for the commercialization of our products and/or introduce additional costs associated with those products80% rewritten
31. 43Changing, new and/or emerging government regulations, including healthcare legislative reform measures, may adversely affect us
32. 44Healthcare reform measures could hinder or prevent the commercial success of our LDTs or any product candidate for which we obtain regulatory approvalNew
33. 45opposed to regulation, for the initial years. Manufacturers that fail to comply with the IRA may be subject to various penalties, some significant, including civil monetary penaltiesNew
34. 46Adequate coverage and reimbursement from third party payors may not be available for our product candidates, which could diminish our sales or adversely affect our ability to sell our products profitably
35. 47Orphan drug designation may not ensure that we will enjoy market exclusivity in a particular market, and if we fail to obtain or maintain orphan drug designation or other regulatory exclusivity for some of our product candidates, our competitive position would be harmed
36. 48Fast Track Designation by the FDA may not lead to a faster development or regulatory review or approval processNew
37. 49If we decide to pursue accelerated approval for any of our product candidates, it may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approvalNew
38. 50If we experience an interruption in supply from a material sole source supplier, our business may be harmed
39. 51We may engage in strategic transactions that could impact our liquidity, increase our expenses, and present significant distractions to our management
40. 52inability to retain key employees of any acquired businesses
41. 53We must maintain quality controls and compliance with manufacturing standards22% rewritten
42. 54If we are unable to identify, hire and/or retain key personnel, we may not be able to sustain or grow our business75% rewritten
43. 55We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate
44. 56A failure to adequately protect health information could result in severe harm to our reputation and subject us to significant liabilities, each of which could have a material adverse effect on our business
45. 57We and our collaborators must comply with environmental laws and regulations, including those pertaining to use of hazardous and biological materials in our business, and failure to comply with these laws and regulations could expose us to significant liabilities
46. 58We may not be successful in our efforts to develop, fully utilize and monetize the CNSide diagnostic portfolio37% rewritten
47. 59Clinical laboratories are highly regulated and if we are unable to maintain compliance with these regulations, or if the regulations change in ways that make it more difficult or costly to comply, our financial condition and our business may be harmed90% rewritten
48. 60coverage, or do not provide sufficient reimbursement for the CNSide Test we may be unable to realize the expected benefits of the test and may not be able to offer it within the expected timeline, or at allNew
49. 61The diagnostic testing industry is subject to rapid change, which could make our current or future products obsoleteNew

Risks Relating to Our Intellectual Property

1. 62Our success depends in part on our ability to protect our intellectual property
2. 63the patents of others may have an adverse effect on our business
3. 64If we do not obtain patent term extension for any product candidates we may develop, our business may be materially harmedNew
4. 65We may not be able to protect our trade secrets
5. 66We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
6. 67We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be unable to protect our rights to our product candidates and technology
7. 68If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business

Risks Relating to the Issuance of Capital Stock, the Securities Markets and an Investment in Our Common Stock

1. 69Our stockholders may experience substantial dilution in the value of their investment if we issue additional shares of our capital stock
2. 70Our certificate of incorporation allows us to issue up to 2,000,000,000 shares of our common stock and to issue and designate the rights of, without stockholder approval, up to 5,000,000 shares of preferred stock
3. 71The market price of our common stock may be volatile and fluctuate significantly, which could result in substantial losses for stockholders
4. 72the trading volume of our common stock
5. 73We may be or become the target of securities litigation, which is costly and time-consuming to defend
6. 74We may issue debt and equity securities or securities convertible into equity securities, any of which may be senior to our common stock as to distributions and in liquidation, which could negatively affect the value of our common stock
7. 75Our charter documents contain anti-takeover provisions
8. 76limit who may call stockholder meetings
9. 77We presently do not intend to pay cash dividends on our common stock
10. 78If securities and/or industry analysts fail to continue publishing research about our business, if they change their recommendations adversely, or if our results of operations do not meet their expectations, our stock price and trading volume could decline
11. 79Increased information technology security threats and more sophisticated and targeted computer crime could pose a risk to our systems, networks, and products