Scynexis (SCYX) risk factors, FY2025 10-K

Scynexis's FY2025 10-K, filed Mar 04, 2026, lists 55 risk factors in 6 groups. Against the prior year's 56: 6 new, 7 dropped, 13 substantially reworded.

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Risk factors listed
556 groups
New this year
6vs 56 last year
Dropped
7since the prior 10-K
Substantially reworded
13of those kept
Section length
19k wordsItem 1A

What the changes say

  • SCY-247 now dominates development, safety, approval, manufacturing and competition risks, replacing much of the prior ibrexafungerp focus.
  • Cash declined to $56.3 million, accumulated deficit reached $385.1 million, and additional financing remains necessary.
  • Nasdaq has given SCYX until June 15, 2026 to restore the $1.00 minimum bid price.
  • Third-party dependence now highlights CRO oversight, SCY-247 manufacturing continuity, data privacy and regulatory compliance.

What changed since the prior 10-K

New

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

    Although the oral formulation of SCY-247 has been granted QIDP status and Fast Track designation, this does not guarantee that the length of the FDA review process will be significantly shorter than otherwise, or that SCY-247 will ultimately be approved by the FDA

    QIDP and Fast Track status may not materially shorten FDA review or ensure SCY-247 approval or GAIN Act exclusivity.

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

    for indications or uses for which they do not have approval. Failure to comply with FDA advertising and promotion standards, which are often subject to interpretation by regulators, may result in a wide range of exposure and liability for us

    Noncompliant advertising, promotion or labeling could trigger corrective actions, fines, trial suspensions, approval refusals or product restrictions.

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

    the payor (e.g., public or private). Similar to the federal Anti-Kickback Statute, a person or entity need not have actual knowledge the statute or specific intent to violate it, in order to have committed a violation

    HIPAA privacy, security and transmission obligations create compliance exposure when handling individually identifiable health information.

  • NewRisks Related to Our Dependence on Third Parties

    with third-party service providers and CROs are and will be on a study-by-study basis and typically short-term. In all cases, we expect to be able to terminate the agreements with notice and be responsible for the supplier’s previously incurred costs

    Limited internal clinical-development capacity makes CRO selection, oversight and timely performance difficult, while outsourcing exposes proprietary information.

  • NewRisks Related to Our Dependence on Third Parties

    As we do not intend to own or operate facilities for manufacturing, storage and distribution of drug substance or drug product we are and will be dependent on third parties for the manufacture of SCY-247. If we experience problems with any of these third parties, the manufacturing of SCY-247 could be delayed

    Reliance on third parties to manufacture SCY-247 creates supply interruptions if suppliers fail regulatory, quality or capacity requirements.

  • NewRisks Relating to Owning Our Common Stock

    If we fail to comply with the continued minimum closing bid requirements of the Nasdaq Capital Market or other requirements for continued listing, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted

    SCYX risks Nasdaq delisting and reduced capital-market access unless its shares close above $1.00 for ten consecutive business days by June 15, 2026.

Dropped

  • DroppedRisks Relating to Our Financial Condition and Need for Additional Capital

    We may not be able to realize the benefits we expect under the GSK License Agreement if we are not able to develop ibrexafungerp

    GSK milestone and royalty benefits depended on further ibrexafungerp development.

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

    approval 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

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

    Our 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

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

    from 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

  • DroppedRisks Relating to Our Intellectual Property

    We 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

  • DroppedRisks Relating to Our Intellectual Property

    difficult. 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

  • DroppedRisks Related to Employee Matters and Managing Growth

    incidents 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

Reworded

  • 95% rewrittenRisks Related to Our Dependence on Third Parties

    We 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

    The risk remains third-party control over drug development, with this year’s text continuing to emphasize outsourced clinical and manufacturing work.

  • 64% rewrittenRisks Relating to the Development, Regulatory Approval and Commercialization of Our Product Candidates For Human Use

    SCY-247 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

    The focus shifts from ibrexafungerp gastrointestinal events to SCY-247 trial safety, serious adverse events in invasive-candidiasis patients and preclinical safety signals.

    Was: Our 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

  • 64% rewrittenRisks Relating to the Development, Regulatory Approval and Commercialization of Our Product Candidates For Human Use

    Pharmaceutical 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

    The excerpt retains the prior focus on Anti-Kickback Statute violations, broader regulatory obligations and significant penalties.

  • 56% rewrittenRisks Relating to the Development, Regulatory Approval and Commercialization of Our Product Candidates For Human Use

    We expect that SCY-247 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

    Competition is reframed around SCY-247 rather than ibrexafungerp and BREXAFEMME, while named antifungal competitors are omitted from the excerpt.

    Was: We 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

  • 42% rewrittenRisks Relating to Our Financial Condition and Need for Additional Capital

    We have a limited history of profitability, we have only one product approved for commercial sale that is licensed to GSK, 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

    SCYX’s accumulated deficit rose from $376.5 million to $385.1 million, cash fell from $75.1 million to $56.3 million, and strategic focus narrowed to SCY-247.

    Was: We 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

  • 41% rewrittenRisks Relating to the Development, Regulatory Approval and Commercialization of Our Product Candidates For Human Use

    SCY-247 or any other future product candidates we may seek to develop, may still face future development and regulatory difficulties

    Regulatory restrictions and costly post-approval requirements now apply to SCY-247 and future candidates, removing specific references to BREXAFEMME and ibrexafungerp.

    Was: BREXAFEMME, ibrexafungerp, or any other future product candidates we may seek to develop, may still face future development and regulatory difficulties

  • 38% rewrittenRisks Relating to Our Intellectual Property

    We 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

    The excerpt retains the prior discussion that patent litigation is costly and may fail to protect or enforce SCYX’s rights.

  • 29% rewrittenRisks Relating to the Development, Regulatory Approval and Commercialization of Our Product Candidates For Human Use

    inability to obtain sufficient funding to commence a clinical trial

    Clinical trials may now be suspended for inadequate funding caused by enrollment delays, additional studies, higher CRO costs or other unforeseen expenses.

  • 26% rewrittenRisks Related to Employee Matters and Managing Growth

    We may need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth

  • 26% rewrittenRisks Relating to the Development, Regulatory Approval and Commercialization of Our Product Candidates For Human Use

    If resistance to SCY-247 develops quickly or cross-resistance with echinocandins becomes more common, our business will be harmed

    Was: If resistance to ibrexafungerp develops quickly or cross-resistance with echinocandins becomes more common, our business will be harmed

  • 25% rewrittenRisks Relating to Our Financial Condition and Need for Additional Capital

    We 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

  • 22% rewrittenRisks Related to Our Dependence on Third Parties

    We may not be successful in establishing and maintaining development and commercialization collaborations, which could adversely affect our ability to develop and commercialize product candidates

  • 22% rewrittenRisks Relating to the Development, Regulatory Approval and Commercialization of Our Product Candidates For Human Use

    In addition, if our current or any future partners have rights to and responsibility for development of SCY-247 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

    Was: In 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

All 55 risk factors

Headings as the filing states them, in filing order.

Risks Relating to Our Financial Condition and Need for Additional Capital

  1. 01We have a limited history of profitability, we have only one product approved for commercial sale that is licensed to GSK, and to date we have generated limited revenue from product sales. As a result, our ability to curtail our losses and sustain profitability is unproven42% rewritten
  2. 02In 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
  3. 03We 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 performance25% rewritten
  4. 04potential liabilities associated with hazardous materials
  5. 05We 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 SCY-247 or any other product candidates we may prioritize
  6. 06relinquish or license on unfavorable terms our rights to any product candidates that we otherwise would seek to develop or commercialize ourselves
  7. 07Unfavorable 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. 08Although the oral formulation of SCY-247 has been granted QIDP status and Fast Track designation, this does not guarantee that the length of the FDA review process will be significantly shorter than otherwise, or that SCY-247 will ultimately be approved by the FDANew
  2. 09Delays 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 SCY-247 or any future product candidates
  3. 10inability to obtain sufficient funding to commence a clinical trial29% rewritten
  4. 11In addition, if our current or any future partners have rights to and responsibility for development of SCY-247 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 candidates22% rewritten
  5. 12We have only submitted one NDA and one efficacy supplemental NDA before, and we may be unable to do so for SCY-247 in additional indications or any future product candidate we may seek to develop
  6. 13The 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
  7. 14If SCY-247 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
  8. 15potential product liability claims
  9. 16If resistance to SCY-247 develops quickly or cross-resistance with echinocandins becomes more common, our business will be harmed26% rewritten
  10. 17SCY-247 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 sales64% rewritten
  11. 18our reputation may suffer
  12. 19We expect that SCY-247 and any future product candidates we may seek to develop will face competition, and most of our competitors have significantly greater resources than we do56% rewritten
  13. 20sales and marketing expertise
  14. 21Healthcare policy changes may have a material adverse effect on us
  15. 22We expect that a portion of the market for SCY-247 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
  16. 23such 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
  17. 24SCY-247 or any other future product candidates we may seek to develop, may still face future development and regulatory difficulties41% rewritten
  18. 25for indications or uses for which they do not have approval. Failure to comply with FDA advertising and promotion standards, which are often subject to interpretation by regulators, may result in a wide range of exposure and liability for usNew
  19. 26Pharmaceutical companies are subject to significant ongoing regulatory obligations and oversight, which may result in significant additional expense and limit our ability to commercialize our products64% rewritten
  20. 27the payor (e.g., public or private). Similar to the federal Anti-Kickback Statute, a person or entity need not have actual knowledge the statute or specific intent to violate it, in order to have committed a violationNew
  21. 28Regulations, guidelines and recommendations published by various government agencies and organizations may affect the use of SCY-247 and any future product candidates we may seek to develop
  22. 29Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
  23. 30Uncertainties 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. 31We 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. 32We 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. 33We 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. 34We may not be successful in establishing and maintaining development and commercialization collaborations, which could adversely affect our ability to develop and commercialize product candidates22% rewritten
  5. 35We 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 ourselves95% rewritten
  6. 36with third-party service providers and CROs are and will be on a study-by-study basis and typically short-term. In all cases, we expect to be able to terminate the agreements with notice and be responsible for the supplier’s previously incurred costsNew
  7. 37As we do not intend to own or operate facilities for manufacturing, storage and distribution of drug substance or drug product we are and will be dependent on third parties for the manufacture of SCY-247. If we experience problems with any of these third parties, the manufacturing of SCY-247 could be delayedNew
  8. 38If we fail to establish or lose our relationships with CROs, our drug development efforts could be delayed

Risks Relating to Our Intellectual Property

  1. 39It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection
  2. 40the patents of others may have a material adverse effect on our business
  3. 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 technology38% rewritten

Risks Related to Employee Matters and Managing Growth

  1. 42We may not be able to manage our business effectively if we are unable to attract and retain key personnel
  2. 43We may need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth26% rewritten
  3. 44We 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. 45the inability to commercialize product candidates
  5. 46Our internal computer systems, or those used by our contract research organizations or other contractors or consultants, may fail or suffer security breaches
  6. 47Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured liabilities
  7. 48Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing
  8. 49Our 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. 50Similar 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

Risks Relating to Owning Our Common Stock

  1. 51The market price of our common stock may be highly volatile
  2. 52trading volume of our common stock
  3. 53Future 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. 54Anti-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
  5. 55If we fail to comply with the continued minimum closing bid requirements of the Nasdaq Capital Market or other requirements for continued listing, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impactedNew

Other Scynexis 10-Ks

  • FY2024 10-K risk factors
    56 risks

    The company relies heavily on the GSK License Agreement for ibrexafungerp commercialization and revenue.

    Filed Mar 12, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.