Scynexis (SCYX) risk factors, FY2024 10-K

Risks Relating to Our Financial Condition and Need for Additional Capital

1. 01We may not be able to realize the benefits we expect under the GSK License Agreement if we are not able to develop ibrexafungerp
2. 02We have a limited history of profitability, we have only one product approved for commercial sale that is licensed to GSK and is subject to a product recall, and to date we have generated limited revenue from product sales. As a result, our ability to curtail our losses and sustain profitability is unproven
3. 03In addition, our expenses could increase if we are required by the U.S. Food and Drug Administration, or the FDA, to perform studies in addition to, or that are larger than, those that we currently expect
4. 04We expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance
5. 05potential liabilities associated with hazardous materials
6. 06We will continue to require substantial additional capital, and if we are unable to raise capital when needed we would be forced to delay, reduce or eliminate our development program for ibrexafungerp and our planned development for SCY-247
7. 07relinquish or license on unfavorable terms our rights to any product candidates that we otherwise would seek to develop or commercialize ourselves
8. 08Unfavorable U.S. and global economic conditions could adversely affect our ability to access capital

Risks Relating to the Development, Regulatory Approval and Commercialization of Our Product Candidates For Human Use

1. 09approval is a lengthy, expensive and uncertain process and there is no guarantee that ibrexafungerp will be approved by the FDA for the additional indications we are pursuing
2. 10Our ability to generate additional significant revenue related to sales of ibrexafungerp by GSK, will depend on the successful development and regulatory approval of ibrexafungerp for indications in addition to the treatment of VVC and RVVC
3. 11Delays in the commencement, enrollment and completion of clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for ibrexafungerp or any future product candidates
4. 12inability to obtain sufficient funding to commence a clinical trial
5. 13In addition, if our current or any future partners have rights to and responsibility for development of ibrexafungerp or any future product candidates, they may fail to meet their obligations to develop and commercialize the product candidates, including clinical trials for these product candidates
6. 14We have only submitted one NDA and one supplemental NDA before, and we may be unable to do so for ibrexafungerp in additional indications or any future product candidate we may seek to develop
7. 15The environment in which our regulatory submissions may be reviewed changes over time, which may make it more difficult to obtain regulatory approval of any of our product candidates we may seek to develop or commercialize
8. 16If BREXAFEMME, ibrexafungerp for other indications or any other future product candidates for which we receive regulatory approval do not achieve broad market acceptance, the revenue that is generated from their sales will be limited
9. 17potential product liability claims
10. 18If resistance to ibrexafungerp develops quickly or cross-resistance with echinocandins becomes more common, our business will be harmed
11. 19Our approved product and product candidates may have undesirable side effects that may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market or otherwise limit their sales
12. 20our reputation may suffer
13. 21We expect that BREXAFEMME, ibrexafungerp for the treatment of other indications, and any future product candidates we may seek to develop will face competition, and most of our competitors have significantly greater resources than we do
14. 22from the echinocandin class, and liposomal amphotericin B from the polyenes class, many of which are currently available in generic form, or expected to be available in generic form at the time IV ibrexafungerp might be approved
15. 23sales and marketing expertise
16. 24Healthcare policy changes may have a material adverse effect on us
17. 25We expect that a portion of the market for BREXAFEMME, ibrexafungerp for other indications, and any other product candidates we may seek to develop will be outside the United States. However, our product candidates may never receive approval or be commercialized outside of the United States
18. 26such approval in a given jurisdiction may be subject to limitations on the indicated uses for which the product may be marketed or require costly post-marketing follow-up studies
19. 27BREXAFEMME, ibrexafungerp, or any other future product candidates we may seek to develop, may still face future development and regulatory difficulties
20. 28Pharmaceutical companies are subject to significant ongoing regulatory obligations and oversight, which may result in significant additional expense and limit our ability to commercialize our products
21. 29Regulations, guidelines and recommendations published by various government agencies and organizations may affect the use of ibrexafungerp and any future product candidates we may seek to develop
22. 30Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
23. 31Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate

Risks Related to Our Dependence on Third Parties

1. 32We are dependent on our license agreement with GSK to commercialize ibrexafungerp other than in the Greater China region and in the Russian Federation and certain other countries, and if GSK is not successful in commercializing ibrexafungerp in these areas, we will lose a significant source of potential revenue
2. 33We are dependent on our existing third-party collaboration with Hansoh to commercialize ibrexafungerp in the Greater China region, and if Hansoh is not successful in commercializing ibrexafungerp in these areas, we will lose a significant source of potential revenue
3. 34We are dependent on our existing third-party collaboration with R-Pharm to commercialize ibrexafungerp in the Russian Federation and certain other countries, and if R-Pharm is not successful in commercializing ibrexafungerp in those countries, we will lose a significant source of potential revenue
4. 35We may not be successful in establishing and maintaining development and commercialization collaborations, which could adversely affect our ability to develop and commercialize product candidates
5. 36We depend on third-party contractors for a substantial portion of our drug development activities and may not be able to control their work as effectively as if we performed these functions ourselves
6. 37If we fail to establish or lose our relationships with CROs, our drug development efforts could be delayed

Risks Relating to Our Intellectual Property

1. 38We were dependent on Merck for the establishment of our intellectual property rights related to ibrexafungerp, and if Merck did not establish our intellectual property rights with sufficient scope to protect ibrexafungerp, we may have limited or no ability to assert intellectual property rights to ibrexafungerp
2. 39It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection
3. 40the patents of others may have a material adverse effect on our business
4. 41We 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 enforce or protect our rights to, or use, our technology
5. 42difficult. For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents

Risks Related to Employee Matters and Managing Growth

1. 43We may not be able to manage our business effectively if we are unable to attract and retain key personnel
2. 44We may need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth
3. 45We may face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product candidate and may have to limit its commercialization
4. 46the inability to commercialize product candidates
5. 47Our internal computer systems, or those used by our contract research organizations or other contractors or consultants, may fail or suffer security breaches
6. 48Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured liabilities
7. 49Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing
8. 50Our data processing activities may subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security
9. 51Similar laws are being considered in several other states, as well as at the federal and local levels, and we expect more states to pass similar laws in the future. These developments may further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties upon whom we rely
10. 52incidents and attendant consequences may cause customers to stop using our services, deter new customers from using our services, and negatively impact our ability to grow and operate our business

Risks Relating to Owning Our Common Stock

1. 53The market price of our common stock may be highly volatile
2. 54trading volume of our common stock
3. 55Future sales and issuances of our common stock or rights to purchase common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall
4. 56Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management