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What changed in SCYNEXIS INC's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of SCYNEXIS INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+281 added−382 removedSource: 10-K (2026-03-04) vs 10-K (2025-03-12)

Top changes in SCYNEXIS INC's 2025 10-K

281 paragraphs added · 382 removed · 200 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

40 edited+35 added−100 removed100 unchanged
Biggest changeKey Development Milestones We are seeking to achieve the following key near term milestones: 7 • to lift the clinical hold placed on ibrexafungerp by the FDA to enable the resumption of enrollment in the MARIO study, a global Phase 3 study to evaluate ibrexafungerp as an oral step-down treatment for IC in the hospital setting; and • to complete the Phase 1 study for SCY-247 to guide for next steps of clinical development.
Biggest changeKey Development Milestones We are seeking to achieve the following key near term milestones: • to complete the ongoing Phase 1 study with the intravenous formulation of SCY-247 in 2026; and • to initiate a Phase 2 study of SCY-247 in IC.
Qualified Infectious Disease Product Exclusivity If the NDA for a QIDP is approved by the FDA, the FDA will extend by an additional five years any non-patent marketing exclusivity period awarded, such as a five-year exclusivity period awarded for a new chemical entity. This extension is in addition to any pediatric exclusivity extension awarded.
Qualified Infectious Disease Product (QIDP) Exclusivity If the NDA for a QIDP is approved by the FDA, the FDA will extend by an additional five years any non-patent marketing exclusivity period awarded, such as a five-year exclusivity period awarded for a new chemical entity. This extension is in addition to any pediatric exclusivity extension awarded.
Moreover, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, the Affordable Care Act, provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act; • the federal civil and criminal false claims laws, including the civil False Claims Act that can be enforced by private citizens through civil whistleblower or qui tam actions and civil monetary penalties laws, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; • the Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; 16 • the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and their implementing regulations, also imposes obligations, including mandatory contractual terms, on “covered entities,” including certain healthcare providers, health plans, healthcare clearinghouses, and their respective “business associates,” that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, as well as analogous state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and • analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non- governmental third-party payors, including private insurers.
Moreover, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, the Affordable Care Act, provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act; • the federal civil and criminal false claims laws, including the civil False Claims Act that can be enforced by private citizens through civil whistleblower or qui tam actions and civil monetary penalties laws, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; • the Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; • the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and their implementing regulations, also imposes obligations, including mandatory contractual terms, on “covered entities,” including certain healthcare providers, health plans, healthcare clearinghouses, and their respective “business associates,” that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, as well as analogous state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and • analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non- governmental third-party payors, including private insurers.
Such obligations may include, without limitation, the Federal Trade Commission Act, the California Consumer Privacy Act of 2018 (CCPA), the Canadian Personal Information Protection and Electronic Documents Act, Canada’s Anti-Spam Legislation, the European Union’s General Data Protection Regulation 2016/679 (EU GDPR), the EU GDPR as it forms part of United 15 Kingdom (UK) law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (UK GDPR), and the Payment Card Industry Data Security Standard (PCI DSS).
Such obligations may include, without limitation, the Federal Trade Commission Act, the California Consumer Privacy Act of 2018 (CCPA), the Canadian Personal Information Protection and Electronic Documents Act, Canada’s Anti-Spam Legislation, the European Union’s General Data Protection Regulation 2016/679 (EU GDPR), the EU GDPR as it forms part of United Kingdom (UK) law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (UK GDPR), and the Payment Card Industry Data Security Standard (PCI DSS).
There also has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices, which has resulted in several Congressional inquiries, Presidential executive orders and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
There also has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices, which has resulted in several Congressional inquiries, Presidential executive orders and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug 14 products.
Other states have also 18 submitted SIP proposals that are pending review by the FDA. Any such approved importation plans, when implemented, may result in lower drug prices for products covered by those programs. The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS and related agencies.
Other states have also submitted SIP proposals that are pending review by the FDA. Any such approved importation plans, when implemented, may result in lower drug prices for products covered by those programs. The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS and related agencies.
Government Regulation Government Regulation 12 Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, including any manufacturing changes, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import and export of pharmaceutical products such as those we are developing.
Government Regulation Government Regulation Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, including any manufacturing changes, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import and export of pharmaceutical products such as those we are developing.
Our employees are engaged in administration, accounting and finance, research, clinical development, manufacturing, and business development functions. We believe our relations with our employees are good. Corporate Information We were incorporated in the State of Delaware on November 4, 1999. Our corporate headquarters are located at 1 Evertrust Plaza, 13 th Floor, Jersey City, New Jersey 07302.
Our employees are engaged in administration, accounting and finance, research, clinical development, manufacturing, and business development functions. We believe our relations with our employees are good. 15 Corporate Information We were incorporated in the State of Delaware on November 4, 1999. Our corporate headquarters are located at 1 Evertrust Plaza, 13 th Floor, Jersey City, New Jersey 07302.
In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution. Information about certain clinical trials must be submitted 13 within specific timeframes to the National Institutes of Health (NIH) for public dissemination on their ClinicalTrials.gov website.
In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution. Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health (NIH) for public dissemination on their ClinicalTrials.gov website.
Preclinical Studies Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND.
Preclinical Studies 9 Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND.
Pediatric Exclusivity Pediatric exclusivity is another type of non-patent marketing exclusivity in the United States and, if granted, provides for the attachment of an additional six months of regulatory protection to the term of any existing exclusivity, including the non-patent exclusivity periods described above, and to the regulatory term of any patent that has been submitted to FDA for the approved drug product.
Pediatric Exclusivity 11 Pediatric exclusivity is another type of non-patent marketing exclusivity in the United States and, if granted, provides for the attachment of an additional six months of regulatory protection to the term of any existing exclusivity, including the non-patent exclusivity periods described above, and to the regulatory term of any patent that has been submitted to FDA for the approved drug product.
Pharmaceutical Coverage, Pricing and Reimbursement The ability to commercialize BREXAFEMME and any of our product candidates successfully will depend in part on the extent to which the United States and foreign governmental authorities, private health insurers and other third-party payors establish appropriate coverage and reimbursement levels for our product candidates and related treatments.
Pharmaceutical Coverage, Pricing and Reimbursement 13 The ability to commercialize BREXAFEMME and any of our product candidates successfully will depend in part on the extent to which the United States and foreign governmental authorities, private health insurers and other third-party payors establish appropriate coverage and reimbursement levels for our product candidates and related treatments.
This rolling review is available if the applicant provides, and the FDA approves, a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA's time period goal for reviewing an application does not begin until the last section of 14 the NDA is submitted.
This rolling review is available if the applicant provides, and the FDA approves, a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA's time period goal for reviewing an application does not begin until the last section of the NDA is submitted.
As a result, with respect to Medicare reimbursement for services in the 17 hospital inpatient setting, hospitals could have a financial incentive to use the least expensive drugs for the treatment of invasive fungal infections, particularly the IV formulations of these drugs, as they are typically administered in the hospital.
As a result, with respect to Medicare reimbursement for services in the hospital inpatient setting, hospitals could have a financial incentive to use the least expensive drugs for the treatment of invasive fungal infections, particularly the IV formulations of these drugs, as they are typically administered in the hospital.
For example, in the United States, sales, marketing and scientific and educational programs also must comply with state and federal fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws.
For example, in the United States, sales, marketing and scientific and educational programs also must comply with state and federal fraud and abuse laws, false 12 claims laws, transparency laws, government price reporting, and health information privacy and security laws.
If approved, we believe that the fungerp's unique features, including being from a novel antifungal class, broad-spectrum of activity including resistant strains, IV and oral formulations, fungicidal activity versus Candida , high tissue penetration, and favorable safety profile, will differentiate it from competing products and allow premium pricing to generics and other competing products.
If approved, we believe that the fungerp's unique features, including being from a novel antifungal class, broad-spectrum of activity including resistant strains, intravenous and oral formulations, fungicidal activity versus Candida , high tissue penetration, and favorable safety profile, will differentiate it from competing products and allow premium pricing to generics and other competing products.
Amphotericin B is also only available via IV administration and is associated with a significant risk of renal toxicity and infusion reactions, making it an unsuitable option in settings where there is underlying, or high risk of, renal impairment. Due to significant monitoring issues, Amphotericin B is also less desirable for outpatient parenteral administration.
Amphotericin B is also only available via intravenous administration and is associated with a significant risk of renal toxicity and infusion reactions, making it an unsuitable option in settings where there is underlying, or high risk of, renal impairment. Due to significant monitoring issues, Amphotericin B is also less desirable for outpatient parenteral administration.
The information contained on, or that can be accessed through, our website is not part of this Annual Report, and the inclusion of our website address in this Annual Report is an inactive textual reference only. 19
The information contained on, or that can be accessed through, our website is not part of this Annual Report, and the inclusion of our website address in this Annual Report is an inactive textual reference only. 16
Competition for the Fungerps Competitors include large pharmaceutical and biotechnology companies, and specialty pharmaceutical and generic drug companies. The leading antifungal drugs representing each main class are as follows: Azoles.
Competition for SCY-247 and Fungerps Competitors include large pharmaceutical and biotechnology companies, and specialty pharmaceutical and generic drug companies. The leading antifungal drugs representing each main class are as follows: Azoles.
Patent No. 7,863,465). The ‘465 patent is currently set to expire in 2029. The SCY-247 composition of matter is covered by a patent in several other jurisdictions worldwide, including Europe, Japan, and China. Employees As of March 1, 2025, we had 28 employees, all of whom were employed on a full-time basis.
Patent No. 7,863,465). The ‘465 patent is currently set to expire in 2029. The SCY-247 composition of matter is covered by a patent in several other jurisdictions worldwide, including Europe, Japan, and China. Employees As of March 1, 2026, we had 18 employees, all of whom were employed on a full-time basis.
As of March 1, 2025, we are the owner of more than ten issued U.S. patents and more than 135 issued non-U.S. patents with claims to novel compounds, compositions containing them, processes for their preparation, and their uses as pharmaceutical agents, with terms expiring between 2027 and 2038.
As of March 1, 2026, we are the owner of more than 10 issued U.S. patents and more than 135 issued non-U.S. patents with claims to novel compounds, compositions containing them, processes for their preparation, and their uses as pharmaceutical agents, with terms expiring between 2027 and 2038.
However, antifungal treatment duration for invasive candidiasis typically extends for several weeks and patients for whom the azoles are not a suitable therapy due to resistance, intolerance, or risk of drug-to-drug interaction are restricted to use IV therapy for several weeks.
However, antifungal treatment duration for IC typically extends for several weeks and patients for whom the azoles are not a suitable therapy due to resistance, intolerance, or risk of drug-to-drug interaction are restricted to use intravenous therapy for several weeks.
Invasive Candidiasis / rIFI Treatment options for IC are limited to three main drug classes: echinocandins, azoles, and amphotericin B. The echinocandins are considered the first line recommended therapy in most invasive candidiasis settings. Because the echinocandins can be administered only intravenously, orally administered azoles are often used as step-down agents after initial IV echinocandin therapy.
Market Opportunity for SCY-247 Invasive Candidiasis Treatment options for IC are limited to three main drug classes: echinocandins, azoles, and amphotericin B. The echinocandins are considered the first line recommended therapy in most IC settings. Because the echinocandins can be administered only intravenously, orally administered azoles are often used as step-down agents after initial intravenous 6 echinocandin therapy.
To qualify as a QIDP according to the criteria established in the GAIN Act, a product must be an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including, those: • caused by an antifungal resistant pathogen, including novel or emerging infectious pathogens; or • qualifying pathogens listed by the FDA in accordance with the GAIN Act.
To be eligible for these benefits a product in development must seek and be awarded designation as a QIDP. 10 To qualify as a QIDP according to the criteria established in the GAIN Act, a product must be an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including, those: • caused by an antifungal resistant pathogen, including novel or emerging infectious pathogens; or • qualifying pathogens listed by the FDA in accordance with the GAIN Act.
Invasive Candidiasis and/or Candidemia Enrollment is on clinical hold in our prospective, randomized, double-blind, global Phase 3 study to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a step-down therapy for patients with IC including candidemia following IV echinocandin therapy in the hospital compared to currently available therapies (the MARIO study).
The MARIO study was a prospective, randomized, double-blind, global Phase 3 study to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a step-down therapy for patients with IC including candidemia following IV echinocandin therapy in the hospital compared to currently available therapies (the MARIO study).
They are being developed as oral and IV formulations and have demonstrated potent activity against a large collection of medically relevant strains of Candida and Aspergillus genera, including multidrug-resistant strains, as well as Pneumocystis , Coccidioides , Histoplasma , and Blastomyces genera.
SCY-247 is being developed as oral and intravenous formulations and has demonstrated potent activity against a large collection of medically relevant strains of Candida and Aspergillus genera, including multidrug-resistant strains, as well as Pneumocystis, Coccidioides, Histoplasma and Blastomyces genera.
Unique attributes of this novel class of antifungals that define its potential to address significant unmet medical needs and provide considerable commercial opportunities include: • oral bioavailability, unlike other glucan synthase inhibitors, allowing for convenient long-term outpatient use; • distinct chemical structure from other glucan synthase inhibitors, providing a unique spectrum of activity and pharmacokinetic profile; • activity against azole-resistant and most echinocandin-resistant Candida strains, including Candida auris and multidrug-resistant strains; • activity against azole-resistant Aspergillus strains; • fungicidal (i.e., killing the fungi) capabilities against the Candida genus compared to azoles, which are fungistatic (i.e., only inhibiting the growth of fungi); • high tissue penetration, allowing high concentrations in the organs commonly affected by fungal infections; • half life adequate for once a day administration; and • low risk of drug-drug interactions.
SCY-247 has unique attributes that define its potential to address significant unmet medical needs and provide considerable commercial opportunities, including: • oral bioavailability, allowing for convenient long-term outpatient use; 5 • activity against azole-resistant and most echinocandin-resistant Candida strains, including Candida auris and multidrug-resistant strains; • activity against azole-resistant Aspergillus strains; • fungicidal (i.e., killing the fungi) capabilities against the Candida genus compared to azoles, which are fungistatic (i.e., only inhibiting the growth of fungi); • high tissue penetration, allowing high concentrations in the organs commonly affected by fungal infections; and • half-life adequate for once a day oral dosing with a low risk of drug-drug interactions.
Patent No. 8,188,085); three issued patents related to ibrexafungerp salts and polymorphs, including the citrate salt used in BREXAFEMME and our ongoing clinical trials; and two patents covering uses of ibrexafungerp in treatment or prevention of fungal infections. The ‘085 patent is currently set to expire in 2030.
Patent No. 8,188,085); three issued patents related to ibrexafungerp salts and polymorphs, including the citrate salt used in BREXAFEMME; and two patents covering uses of ibrexafungerp in treatment or prevention of fungal infections.
We believe that SCY-247, if approved, has the potential to address significant gaps with commercially available therapies for certain indications. 8 For the treatment of invasive fungal infections, we expect that prescribing physicians will be located at major medical centers, where physicians specializing in critical care, infectious disease specialists, and physicians treating immune compromised or immuno-suppressed patients, such as oncologists and those performing solid organ transplants and stem cell transplants, are likely to be found.
For the treatment of invasive fungal infections, we expect that prescribing physicians will be located at major medical centers, where physicians specializing in critical care, infectious disease specialists, and physicians treating immune compromised or immuno-suppressed patients, such as oncologists and those performing solid organ transplants and stem cell transplants, are likely to be found.
The commercial opportunity for the fungerps could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than products that we or GSK (in the case of ibrexafungerp) may develop.
The commercial opportunity for the fungerps could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than products that we may develop. Competitors also may obtain FDA, or other regulatory, approval for their products more rapidly than we obtain approvals.
We have applied for patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) and believe that the term of the ‘085 patent will be extended into 2035. The three patents covering the citrate salt of ibrexafungerp expire in 2035. The two patents covering uses of ibrexafungerp expire in 2038.
The ‘085 patent is set to expire in 2035 following a grant of patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act). The three patents covering the citrate salt of ibrexafungerp expire in 2035. The two patents covering uses of ibrexafungerp expire in 2038.
We do not own or operate and do not intend to own or operate facilities for manufacturing, storage and distribution, or testing of drug substance or drug product. We have relied on third-party contract manufacturers for synthesis of our clinical compounds and manufacture of drug product.
We do not own or operate and do not intend to own or operate facilities for manufacturing, storage and distribution, or testing of drug substance or drug product.
Manufacturing and Supply of Ibrexafungerp and SCY-247 10 Ibrexafungerp is a semi-synthetic compound that involves fermentation and synthetic chemical steps in its manufacturing process. The synthetic process does not require any specialized equipment and uses readily sourced intermediates.
If approved, we believe the fungerps will be capable of delivering value supportive of premium pricing over competitive generic products. Manufacturing and Supply of SCY-247 SCY-247 is a semi-synthetic compound that involves fermentation and synthetic chemical steps in its manufacturing process. The synthetic process does not require any specialized equipment and uses readily sourced intermediates.
A drug manufacturing program subject to extensive governmental regulations requires robust quality assurance systems and experienced personnel with the relevant technical and regulatory expertise as well as strong project management skills. We believe we have a team that is capable of managing these activities.
We have relied on third-party contract manufacturers for synthesis of our clinical compounds and manufacture of drug product. 7 A drug manufacturing program subject to extensive governmental regulations requires robust quality assurance systems and experienced personnel with the relevant technical and regulatory expertise as well as strong project management skills.
Triterpenoid Antifungals The triterpenoid antifungals (the fungerps) are a novel antifungal class that act through the inhibition of the glucan synthase complex, an established target in antifungal therapeutics.
SCY-247 Target Product Profile SCY-247, the second agent in a novel antifungal class, acts through the inhibition of the glucan synthase complex, an established target in antifungal therapeutics.
Specifically, 90% of Candida auris isolates have been reported to be resistant to at least one antifungal agent and 30% of isolates resistant to at least two antifungals. 9 There is a clear need for new antifungal treatment options for patients with IC that are refractory or intolerant to available therapies as well as for those who would benefit from oral therapy.
Specifically, 90% of Candida auris isolates have been reported to be resistant to at least one antifungal agent and 30% of isolates resistant to at least two antifungals. There is a clear need for new antifungal treatment options for patients with IC and we believe SCY-247 has the potential to address many of these unmet needs.
Our Strategy Key elements of our strategy include: • to leverage our strong scientific team to pursue the development of other internal proprietary compounds, including SCY-247; • to maximize ibrexafungerp’s value, in line with the GSK License Agreement, by delivering the results of completed and ongoing clinical trials under our responsibility enabling further expansion of indications including invasive fungal infections; and • to assess external opportunities for in-licensing to expand our development pipeline and add products for commercialization.
Our Strategy Key elements of our strategy include: • to leverage our strong scientific team to pursue the development of SCY-247 and other internal proprietary compounds; • to explore potential non-dilutive funding opportunities to further support SCY-247; and • to assess external opportunities for in-licensing to expand our development pipeline and add products for commercialization.
In June 2021 and December 2022, we announced that the United States (U.S.) Food and Drug Administration (FDA) approved BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection, and for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC), respectively. Oral ibrexafungerp is also under development for other systemic fungal diseases.
Ibrexafungerp is the first representative of this novel class of antifungals and was approved by the U.S. Food and Drug Administration (FDA) as BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis (VVC) and for the reduction in the incidence of recurrent vulvovaginal candidiasis (rVVC) in 2021 and 2022, respectively. Ibrexafungerp was licensed to GSK in May 2023.
ITEM 1. BUSINESS Overview SCYNEXIS, Inc. is pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections.
ITEM 1. BUSINESS Overview SCYNEXIS, Inc. is dedicated to advancing innovative solutions for severe rare diseases, with our lead program in the treatment and prevention of difficult-to-treat and drug-resistant fungal infections.
In the azole class, fluconazole, itraconazole, posaconazole, and oral voriconazole are generic. Caspofungin, the largest selling echinocandin, is now available on a generic basis. If approved, we believe the fungerps will be capable of delivering value supportive of premium pricing over competitive generic products.
In addition, the commercial success of SCY-247 may be affected because in many cases insurers or other third-party payors seek to encourage the use of generic products. In the azole class, fluconazole, itraconazole, posaconazole, and oral voriconazole are generic. Caspofungin, the largest selling echinocandin, is available on a generic basis.
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Ibrexafungerp is the first representative of this novel class of antifungals with additional assets from the “fungerp” family under development, including SCY-247 which is currently in clinical stages of development.
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A second generation fungerp SCY-247 is currently being evaluated in clinical trials and additional compounds from our proprietary fungerp platform, targeted to address significant unmet needs, are in earlier stages of development.
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SCY-247, a second-generation antifungal compound from this novel class, is in clinical development and we initiated a Phase 1 study for SCY-247 in the fourth quarter of 2024.
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The FDA has granted Qualified Infectious Disease Product status and Fast Track designations for the oral formulation of SCY-247 which would provide regulatory exclusivity of at least 10 years following commercial launch, if approved.
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The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to ibrexafungerp for the indications of VVC (including the prevention of recurrent VVC), invasive candidiasis (IC) (including candidemia), and invasive aspergillosis (IA), and has granted Orphan Drug designations for the IC and IA indications.
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SCY-247 Development Update We continue to progress the development activities for SCY-247 and recently completed the single and multiple ascending dose portions of our ongoing Phase 1 study of oral SCY-247 in 88 healthy subjects.
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The European Medicines Agency has granted Orphan Medicinal Product designation to ibrexafungerp for IC. We anticipate that the FDA may grant QIDP and Fast Track designations for the IV and oral formulations of SCY-247. These designations may provide us with additional market exclusivity and expedited regulatory paths.
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The study evaluated the safety, tolerability and pharmacokinetics of orally administered SCY-247 in healthy participants receiving single ascending doses (SAD) ranging from 50mg to 900mg and multiple ascending doses (MAD) ranging from 50mg to 300mg, once a day for 7 days. Each dose level was evaluated in eight participants, with six participants receiving SCY-247 and two receiving a matching placebo.
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GSK License Agreement On March 30, 2023, we entered into a license agreement (as amended in December 2023, the GSK License Agreement) with GSK.
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A total of 66 participants received SCY-247 and 22 received placebo in the SAD and MAD cohorts. SCY-247 was well tolerated across all evaluated SAD and MAD cohorts. No serious or severe treatment emergent adverse events (TEAEs) were reported. The incidence of TEAEs was low and not dose-dependent, with all events being mild or moderate in severity.
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Pursuant to the terms of the GSK License Agreement, we granted GSK an exclusive (even as to us and our affiliates), royalty-bearing, sublicensable license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in all countries other than those in the Greater China region and certain other countries already licensed to third parties (the GSK Territory).
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One participant discontinued the study due to an adverse event that was deemed not to be related to the study drug. SCY-247 showed generally dose-proportional pharmacokinetics following single and multiple oral doses.
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The parties closed the transactions contemplated by the GSK License Agreement in May 2023 and we received an upfront payment of $90.0 million. In June 2023 and July 2024, we announced the achievement of a $25.0 million and a $10.0 million performance-based development milestone under the GSK License Agreement, respectively.
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The drug was rapidly absorbed (Tmax ranging from three to seven hours), and systemic exposure (Cmax and AUC) increased proportionally for doses up to 400mg QD and less than proportional for doses higher than 400mg QD.
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On December 26, 2023, we and GSK entered into a binding memorandum of understanding (Binding MOU) for amendment to the GSK License Agreement. The GSK License Agreement was amended in connection with the delay in the commercialization of BREXAFEMME (see "Product Recall and Clinical Hold" below) and further clinical development of ibrexafungerp associated with this event.
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The MAD cohorts of 200mg and 300mg once-daily achieved or exceeded the preliminary target for efficacious exposure, based on preclinical models of invasive candidiasis (IC) available to date, including models with strains such as Candida auris and echinocandin-resistant Candida glabrata that are resistant to current antifungal treatment options.
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Under the terms of the updated GSK License Agreement, as amended by the Binding MOU, we are eligible to receive potential: • regulatory approval milestone payments of up to $49 million (revised from up to $70 million as provided in the GSK License Agreement); • commercial milestone payments of up to $57.5 million based on first commercial sale in IC (U.S./EU) (revised from up to $115 million as provided in the GSK License Agreement); and • and sales milestone payments of up to $179.5 / $169.75 / $145.5 million (depending on the date of GSK’s relaunch of BREXAFEMME in the U.S.) (revised from up to $242.5 million as provided in the GSK License Agreement).
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Overall, the safety, tolerability, and pharmacokinetic profile observed in this study support the continued clinical development of SCY-247. We intend to progress the development of SCY-247 towards addressing significant unmet needs in the antifungal space that also represent attractive commercial opportunities. We have initiated a Phase 1 study with the intravenous formulation of SCY-247 in the first quarter of 2026.
Removed
These milestones are based on annual net sales in the GSK Territory, with a total of $64 / $54.25 / $46.5 million to be paid upon achievement of multiple sales thresholds up through $200 million; a total of $45.5 / $45.5 / $39 million to be paid 5 upon achievement of multiple sales thresholds between $300 million and $500 million; and $35 / $35 / $30 million to be paid at each sales threshold of $750 million and $1 billion.
Added
The clinical proof-of-concept Phase 2 study of SCY-247 is currently planned for 2026 in patients with IC. Subsequent stages of development for SCY-247 are anticipated to include studies adequate to support an IC treatment indication, as well as evaluating SCY-247 for the prevention of invasive fungal infections (IFI) in patients at high risk.
Removed
We will continue to be responsible for the execution and costs of the ongoing clinical studies of ibrexafungerp, which at this stage is only the MARIO study, but will have the potential to receive up to $72.35 million in development milestones (revised from up to $75.5 million as provided in the GSK License Agreement), which comprise: $25 million already paid; $10 million already paid for the delivery to GSK of the final clinical study reports for the completed FURI, CARES, and NATURE clinical studies; up to $30 million for the achievement of two interim milestones associated with our resumption and continued performance of the MARIO study (as defined below) after the clinical hold is lifted; and $7.35 million for the successful completion of the MARIO study.
Added
Additionally, SCY-247 has shown in vitro , and in vivo activity against multidrug-resistant organisms such as Candida auris and synergistic/additive activity in combination with amphotericin B against fungi causing mucormycosis.
Removed
In the case of each of the above milestones, such milestone events are defined in the GSK License Agreement, as amended by the Binding MOU. GSK will also pay royalties based on cumulative annual sales to us in the mid-single digit to mid-teen range. The royalty terms are not amended by the Binding MOU.
Added
We believe that SCY-247, if approved, has the potential to address significant gaps with commercially available therapies in the following indications: • IC, including resistant infections. IC is a systemic infection by fungi of the Candida spp. genus that typically affects patients in the hospital that are either immunocompromised or undergoing invasive procedures.
Removed
Product Recall and Clinical Hold Following a review in 2023 by GSK of the manufacturing process and equipment at the vendor that manufactures the ibrexafungerp drug substance, we became aware that exetimibe, a non-antibacterial beta-lactam drug substance, was manufactured using equipment common to the manufacturing process for ibrexafungerp.
Added
It is the most common type of invasive fungal infection; can affect the blood, liver, spleen, pleural space, and other organs and the mortality remains very high (i.e., >30%). The recommended treatment for most cases is intravenous echinocandins, with a potential to step-down to oral azoles when the Candida strains are susceptible.
Removed
Current FDA draft guidance recommends segregating the manufacture of non-antibacterial beta-lactam compounds from other compounds since beta-lactam compounds have the potential to act as sensitizing agents that may trigger hypersensitivity or an allergic reaction in some people. In the absence of the recommended segregation, there is a risk of cross contamination.
Added
Antifungal treatment duration typically ranges from two to six weeks.
Removed
It is not known whether any ibrexafungerp has been contaminated with a beta-lactam compound and we have not received any reports of adverse events due to the possible beta-lactam cross contamination.
Added
With an increased frequency of antifungal resistance among several Candida species including C. auris, C. glabrata, C .krusei, C. parapsilosis current antifungal treatment gaps include lack of oral options for azole-resistant strains, safe and well tolerated options for echinocandin-resistant strains, an antifungal with broad and potent anti- Candida activity covering all strains for cases where the susceptibility of the Candida spp. causing the infection is unknown.
Removed
Nonetheless, out of an abundance of caution and in line with GSK’s recommendation, we recalled BREXAFEMME® (ibrexafungerp tablets) from the market and placed a temporary hold on the clinical studies of ibrexafungerp, including the Phase 3 MARIO study.
Added
Amphotericin B may be an option to treat IC that are resistant to other antifungals; however, it is only available via intravenous administration and is associated with a significant risk of renal toxicity and infusion reactions, making it an unsuitable option in settings where there is underlying, or high risk of, renal impairment.
Removed
We are in the process of destroying all of the patient-level and clinical drug product returned to date with the assistance of an experienced vendor and we are substantially complete with the product recall. In September 2023, after we announced our voluntary clinical hold, the FDA concurred with our voluntary hold and placed a clinical hold.
Added
Due to significant monitoring issues, Amphotericin B is also less desirable for outpatient parenteral administration.
Removed
We are working with the FDA to discuss paths for resolution of this issue. The clinical hold and recall affected the Phase 3 MARIO study. Our clinical stage compound, SCY-247, was not affected by these developments.
Added
SCY-247 has demonstrated potent in vitro activity against all clinically relevant Candida species, including multi-drug resistant and has demonstrated efficacy in preclinical IC models against azole-resistant and echinocandin-resistant Candida strains including C. auris, C. glabrata (some of the most difficult to treat Candida infections). • Prevention of IFI in patients at high risk.
Removed
In response to the hold on clinical studies of ibrexafungerp by the FDA due to possible beta-lactam cross contamination, we have entered into certain new manufacturing agreements with third-party contract manufacturers to produce new batches of ibrexafungerp which we believe will allow us to lift the clinical hold and restart the Phase 3 MARIO study.
Added
Since invasive fungal infections (i.e., IC, invasive aspergillosis, mucormycosis, pneumocystis pneumonia, etc.) have poor outcomes in patients that are immunocompromised, antifungal prophylaxis aiming to prevent such infections during the periods of highest risk has become a standard practice in most institutions.
Removed
We are working on the resolution of this issue and we anticipate the restart of the Phase 3 MARIO study, after the FDA's lifting of the clinical hold, in the second quarter of 2025.
Added
The patients that typically receive these preventive antifungal approaches include those with leukemia or other types of cancer that are receiving chemotherapy and or bone marrow transplant as well as those with solid organ transplants such as lung and liver.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

110 edited+15 added−28 removed247 unchanged
Biggest changeWe or others may subsequently identify undesirable or unacceptable side effects caused by BREXAFEMME or any future product candidate we may seek to develop, in which case: • regulatory authorities may require the addition of labeling statements, specific warnings, precautions, contraindications or field alerts to physicians and pharmacies; • we or GSK may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product; • there may be limitations on how the product can be promoted; • sales of the product may decrease significantly; • regulatory authorities may require us or GSK to take our approved product off the market; • we may be subject to litigation or product liability claims; and • our reputation may suffer.
Biggest changeWe or others may subsequently identify undesirable or unacceptable side effects caused by SCY-247 or any future product candidate we may seek to develop, in which case: • regulatory authorities may require the addition of labeling statements, specific warnings, precautions, contraindications or field alerts to physicians and pharmacies; • we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product; • there may be limitations on how the product can be promoted; • sales of the product may decrease significantly; • regulatory authorities may require us to take our approved product off the market; • we may be subject to litigation or product liability claims; and • our reputation may suffer. 22 Any of these events could prevent us or our current or potential future partners from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of products.
The commencement, enrollment and completion of clinical trials can be delayed for a variety of reasons, including: • inability to reach agreements on acceptable terms with prospective clinical research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • difficulty identifying and engaging qualified clinical investigators; • regulatory objections to commencing a clinical trial or proceeding to the next phase of investigation, including inability to reach agreement with the FDA or non-U.S. regulators regarding the scope or design of our clinical trials or for other reasons such as safety concerns that might be identified during preclinical development or early stage clinical trials; • inability to identify and maintain a sufficient number of eligible trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our product candidates; 22 • withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care; • inability to obtain institutional review board (or ethics review committee) approval to conduct a clinical trial at prospective sites; • difficulty identifying, recruiting and enrolling eligible patients to participate in clinical trials for a variety of reasons, including meeting the enrollment criteria for our study and competition from other clinical trial programs for the same indication as product candidates we seek to commercialize; • inability to retain patients in clinical trials due to the treatment protocol, personal issues, side effects from the therapy or lack of efficacy; • inability to produce and/or obtain in a timely manner sufficient quantity of our products to satisfy the requirements of the clinical trials; • inability to enroll patients, or slow down in the rate of enrolling patients, in clinical trials due to unforeseen natural disasters, public health crises, political crises and other catastrophic events or other events outside of our control, such as COVID-19, which may cause participants to not want to participate in these trials or otherwise have any unnecessary contact with the medical community; and • inability to obtain sufficient funding to commence a clinical trial.
The commencement, enrollment and completion of clinical trials can be delayed for a variety of reasons, including: • inability to reach agreements on acceptable terms with prospective clinical research organizations (CROs) and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • difficulty identifying and engaging qualified clinical investigators; • regulatory objections to commencing a clinical trial or proceeding to the next phase of investigation, including inability to reach agreement with the FDA or non-U.S. regulators regarding the scope or design of our clinical trials or for other reasons such as safety concerns that might be identified during preclinical development or early stage clinical trials; • inability to identify and maintain a sufficient number of eligible trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our product candidates; • withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care; • inability to obtain institutional review board (or ethics review committee) approval to conduct a clinical trial at prospective sites; • difficulty identifying, recruiting and enrolling eligible patients to participate in clinical trials for a variety of reasons, including meeting the enrollment criteria for our study and competition from other clinical trial programs for the same indication as product candidates we seek to commercialize; • inability to retain patients in clinical trials due to the treatment protocol, personal issues, side effects from the therapy or lack of efficacy; • inability to produce and/or obtain in a timely manner sufficient quantity of our products to satisfy the requirements of the clinical trials; • inability to enroll patients, or slow down in the rate of enrolling patients, in clinical trials due to unforeseen natural disasters, public health crises, political crises and other catastrophic events or other events outside of our control, such as COVID-19, which may cause participants to not want to participate in these trials or otherwise have any unnecessary contact with the medical community; and 19 • inability to obtain sufficient funding to commence a clinical trial.
The degree of market acceptance of product candidates will depend on a number of factors, including: • limitations or warnings contained in the FDA-approved labeling; • changes in the standard of care for the targeted indications; • limitations in the approved indications; • availability of alternative therapies with potentially advantageous results, or other products with similar results at similar or lower cost, including generics and over-the-counter products; • lower demonstrated clinical safety or efficacy compared to other products; • occurrence of significant adverse side effects; • ineffective sales, marketing and distribution support; • lack of availability of coverage and adequate reimbursement from governmental health care programs, managed care plans and other third-party payors; • timing of market introduction and perceived effectiveness of competitive products; • lack of cost-effectiveness; • adverse publicity about our product candidates or favorable publicity about competitive products; • lack of convenience and ease of administration; and • potential product liability claims.
The degree of market acceptance of product candidates will depend on a number of factors, including: • limitations or warnings contained in the FDA-approved labeling; • changes in the standard of care for the targeted indications; • limitations in the approved indications; • availability of alternative therapies with potentially advantageous results, or other products with similar results at similar or lower cost, including generics and over-the-counter products; • lower demonstrated clinical safety or efficacy compared to other products; • occurrence of significant adverse side effects; • ineffective sales, marketing and distribution support; • lack of availability of coverage and adequate reimbursement from governmental health care programs, managed care plans and other third-party payors; • timing of market introduction and perceived effectiveness of competitive products; • lack of cost-effectiveness; 21 • adverse publicity about our product candidates or favorable publicity about competitive products; • lack of convenience and ease of administration; and • potential product liability claims.
For example, on November 6, 2024, we entered into a Controlled Equity Offering SM Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co., as sales agent, pursuant to which we may issue and sell shares of our common stock for an aggregate maximum offering price of $50.0 million under an “at-the-market” offering program under which we have sold zero shares of our common stock as of December 31, 2024.
For example, on November 6, 2024, we entered into a Controlled Equity Offering SM Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co., as sales agent, pursuant to which we may issue and sell shares of our common stock for an aggregate maximum offering price of $50.0 million under an “at-the-market” offering program under which we have sold zero shares of our common stock as of December 31, 2025.
These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA.
These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and 24 make changes to the Medicare Drug Price Negotiation Program created under the IRA.
For example, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations, impose certain obligations with respect to safeguarding the privacy, security and transmission of individually identifiable health information on “covered entities,” such as certain healthcare providers, health plans, and healthcare clearinghouses and their respective “business associates” that perform services for them.
For example, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations, impose certain 34 obligations with respect to safeguarding the privacy, security and transmission of individually identifiable health information on “covered entities,” such as certain healthcare providers, health plans, and healthcare clearinghouses and their respective “business associates” that perform services for them.
Furthermore, any new legislation addressing drug safety issues could result in delays or increased costs during the period of product development, clinical trials and regulatory review and approval, as well as increased costs to assure compliance with any new post-approval regulatory requirements. Any of these restrictions or requirements could force us or our partners to conduct costly studies.
Furthermore, any new legislation addressing drug safety issues could result in delays or increased costs during the period of product development, clinical trials and regulatory review and approval, as well as increased costs to assure compliance with any new post-approval regulatory requirements. Any of these restrictions or requirements could force us or our potential partners to conduct costly studies.
Moreover, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label.” Although off-label 35 prescriptions may infringe or contribute to or induce the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.
Moreover, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label.” Although off-label prescriptions may infringe or contribute to or induce the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.
We rely on third-party service providers and technologies to operate critical business systems to process confidential, proprietary, and sensitive data in a variety of contexts, including, without limitation, CROs, CMOs, cloud-based infrastructure, data center facilities, encryption and authentication technology, employee email, content delivery to customers, and other functions.
We rely on third-party service providers and technologies to operate critical business systems to process confidential, proprietary, and sensitive data in a variety of contexts, including, without limitation, CROs, CMOs, cloud-based infrastructure, data center facilities, encryption and authentication 36 technology, employee email, content delivery to customers, and other functions.
If we fail to achieve successful collaborations, our operating results and financial condition will be materially and adversely affected. 33 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.
If we fail to achieve successful collaborations, our operating results and financial condition will be materially and adversely affected. 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.
In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have improperly used or disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against these claims.
In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have improperly 32 used or disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against these claims.
Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. As such, we may not promote products for indications or uses for which they do not have approval.
Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. As such, we may not promote products 25 for indications or uses for which they do not have approval.
Government agencies may issue regulations and guidelines directly applicable to us, our partners or our potential future partners and our product candidates. In addition, professional societies, practice management groups, private health/science foundations and organizations involved in various diseases from time to time publish guidelines or recommendations to the 31 healthcare and patient communities.
Government agencies may issue regulations and guidelines directly applicable to us, our partners or our potential future partners and our product candidates. In addition, professional societies, practice management groups, private health/science foundations and organizations involved in various diseases from time to time publish guidelines or recommendations to the healthcare and patient communities.
We outsource, and intend to continue to outsource, substantial portions of our drug development activities to third-party service providers, including manufacturing and the conduct of our clinical trials and various preclinical studies. Our agreements with third-party service providers and CROs are and will be on a study-by-study basis and typically short-term.
We outsource, and intend to continue to outsource, substantial portions of our drug development activities to third-party service providers, including manufacturing and the conduct of our clinical trials and various preclinical studies. Our agreements 29 with third-party service providers and CROs are and will be on a study-by-study basis and typically short-term.
Furthermore, coverage of, and reimbursement for, drugs can differ significantly from payor to payor and may require significant time and resources to obtain. In addition, new laws or regulations could impact future coverage and reimbursement. 27 Healthcare policy changes may have a material adverse effect on us.
Furthermore, coverage of, and reimbursement for, drugs can differ significantly from payor to payor and may require significant time and resources to obtain. In addition, new laws or regulations could impact future coverage and reimbursement. Healthcare policy changes may have a material adverse effect on us.
If we are unable to successfully manage this growth, our business may be adversely affected. 37 Other Risks Relating to Our Business We 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.
If we are unable to successfully manage this growth, our business may be adversely affected. Other Risks Relating to Our Business We 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.
For example: • others may be able to make compounds that are similar to ibrexafungerp and any future product candidates we may seek to develop but that are not covered by the claims of our patents; • if we encounter delays in our clinical trials, the period of time during which we could market our drug candidates under patent protection would be reduced; • we might not have been the first to conceive, make or disclose the inventions covered by our patents or pending patent applications; • we might not have been the first to file patent applications for these inventions; • any patents that we obtain may be invalid or unenforceable or otherwise may not provide us with any competitive advantages; or • the patents of others may have a material adverse effect on our business.
For example: • others may be able to make compounds that are similar to SCY-247, ibrexafungerp and any future product candidates we may seek to develop but that are not covered by the claims of our patents; • if we encounter delays in our clinical trials, the period of time during which we could market our drug candidates under patent protection would be reduced; • we might not have been the first to conceive, make or disclose the inventions covered by our patents or pending patent applications; • we might not have been the first to file patent applications for these inventions; • any patents that we obtain may be invalid or unenforceable or otherwise may not provide us with any competitive advantages; or • the patents of others may have a material adverse effect on our business.
In addition, the design of a clinical trial can determine whether 23 its results will support approval of a product application, or approval of a supplemental application to add a new indication or other changes, and flaws or shortcomings in the design of a clinical trial may not become apparent until the clinical trial is well advanced.
In addition, the design of a clinical trial can determine whether its results will support approval of a product application, or approval of a supplemental application to add a new indication or other changes, and flaws or shortcomings in the design of a clinical trial may not become apparent until the clinical trial is well advanced.
Although there are 39 currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States in compliance with law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S.
Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States in compliance with law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S.
The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) which prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, regardless of the payor (e.g., public or private).
The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) which prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, regardless of 26 the payor (e.g., public or private).
If we are sued for patent infringement, we would need to demonstrate that our products or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and we may not be able to do this. Proving invalidity or unenforceability is 36 difficult.
If we are sued for patent infringement, we would need to demonstrate that our products or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and we may not be able to do this. Proving invalidity or unenforceability is difficult.
The product development and regulatory review process typically takes years to complete, involves numerous uncertainties and the potential for concerns to emerge late in the development process, and approval is never guaranteed.
The product development and regulatory review process 18 typically takes years to complete, involves numerous uncertainties and the potential for concerns to emerge late in the development process, and approval is never guaranteed.
As described above, such effects include the risks that: • ibrexafungerp and any future product candidates we may seek to develop may not generate preclinical or clinical data that are deemed sufficient by regulators in a given jurisdiction; • ibrexafungerp may not be approved for all indications requested, or any indications at all, in a given jurisdiction which could limit the uses of ibrexafungerp and any future product candidates we may seek to develop and have an adverse effect on product sales and potential royalties; and • such 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.
As described above, such effects include the risks that: • SCY-247 and any future product candidates we may seek to develop may not generate preclinical or clinical data that are deemed sufficient by regulators in a given jurisdiction; • SCY-247 may not be approved for all indications requested, or any indications at all, in a given jurisdiction which could limit the uses of SCY-247 and any future product candidates we may seek to develop and have an adverse effect on product sales and potential royalties; and • such 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.
Furthermore, a third party may claim that we or our manufacturing or commercialization partners or customers are using inventions covered by the third party’s patent rights and may go to court to stop us or our partners and/or customers from engaging in our operations and activities, including making or selling ibrexafungerp and any future product candidates we may seek to develop.
Furthermore, a third party may claim that we or our manufacturing or commercialization partners or customers are using inventions covered by the third party’s patent rights and may go to court to stop us or our partners and/or customers from engaging in our operations and activities, including making or selling SCY-247, ibrexafungerp, and any future product candidates we may seek to develop.
Security 41 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.
Security 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.
The conduct of successful Phase 2 and Phase 3 clinical trials is essential in obtaining regulatory approval, and the submission of a successful NDA is a complicated process.
The conduct of successful Phase 1, Phase 2 and Phase 3 clinical trials is essential in obtaining regulatory approval, and the submission of a successful NDA is a complicated process.
Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of ibrexafungerp and any future product candidates we may seek to develop and the methods used to manufacture them, as well as successfully defending these patents against third-party challenges.
Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of SCY-247, ibrexafungerp, and any future product candidates we may seek to develop and the methods used to manufacture them, as well as successfully defending these patents against third-party challenges.
In addition, companies trading in the stock market in general, and the Nasdaq Global Market in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
In addition, companies trading in the stock market in general, and the Nasdaq Capital Market in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
Moreover, if a rapid and accurate test of the susceptibility of a fungal infection to generically available treatments is developed and widely adopted, the market for ibrexafungerp may suffer. If resistance to ibrexafungerp develops quickly or cross-resistance with echinocandins becomes more common, our business will be harmed. We recognize that, over time, resistance develops against every antibacterial and antifungal drug.
Moreover, if a rapid and accurate test of the susceptibility of a fungal infection to generically available treatments is developed and widely adopted, the market for SCY-247 may suffer. If resistance to SCY-247 develops quickly or cross-resistance with echinocandins becomes more common, our business will be harmed. We recognize that, over time, resistance develops against every antibacterial and antifungal drug.
We do not know whether our current clinical trials of ibrexafungerp and SCY-247 will be completed on schedule or at all, or whether any future clinical trials of ibrexafungerp or any future product candidates we may seek to develop will be allowed to commence or, if commenced, will be completed on schedule or at all.
We do not know whether our current clinical trials of SCY-247 will be completed on schedule or at all, or whether any future clinical trials of SCY-247 or any future product candidates we may seek to develop will be allowed to commence or, if commenced, will be completed on schedule or at all.
However, the trading price of our common stock as listed on the Nasdaq Global Market has traded at or below the exercise price of a significant portion of the stock options currently held by our executive officers and key employees.
However, the trading price of our common stock as listed on the Nasdaq Capital Market has traded at or below the exercise price of a significant portion of the stock options currently held by our executive officers and key employees.
When we are required to secure additional financing, the additional fundraising efforts may divert our management from our day-to-day activities, which may adversely affect our ability to develop ibrexafungerp and any product candidates we may seek to develop. In addition, we cannot guarantee that financing will be available in sufficient amounts or on terms acceptable to us, if at all.
When we are required to secure additional financing, the additional fundraising efforts may divert our management from our day-to-day activities, which may adversely affect our ability to develop SCY-247 and any product candidates we may seek to develop. In addition, we cannot guarantee that financing will be available in sufficient amounts or on terms acceptable to us, if at all.
The results of our clinical trials may show that ibrexafungerp and any future product candidates we may seek to develop cause undesirable or unacceptable side effects, which could interrupt, delay or halt clinical trials, resulting in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities, or may lead us to abandon their development altogether.
The results of our clinical trials may show that SCY-247 and any future product candidates we may seek to develop cause undesirable or unacceptable side effects, which could interrupt, delay or halt clinical trials, resulting in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities, or may lead us to abandon their development altogether.
A significant use of antifungal drugs consists of treatment due to the presence of symptoms before diagnosis of the invasive fungal infections, and if recently approved diagnostic tools, or additional tools currently under development, for the quick diagnosis of invasive fungal infections are broadly used in the marketplace, the number of treatments using antifungal drugs may decrease significantly, decreasing the potential market for ibrexafungerp.
A significant use of antifungal drugs consists of treatment due to the presence of symptoms before diagnosis of the invasive fungal infections, and if recently approved diagnostic tools, or additional tools currently under development, for the quick diagnosis of invasive fungal infections are broadly used in the marketplace, the number of treatments using antifungal drugs may decrease significantly, decreasing the potential market for SCY-247.
Third-party payors may refuse to include a particular branded drug in their formularies when a competing generic product is available. The adoption of certain payment methodologies by third-party payors may limit our ability to profit from the sale of ibrexafungerp. For example, under Medicare, hospitals are reimbursed under an inpatient prospective payment system.
Third-party payors may refuse to include a particular branded drug in their formularies when a competing generic product is available. The adoption of certain payment methodologies by third-party payors may limit our ability to profit from the sale of SCY-247. For example, under Medicare, hospitals are reimbursed under an inpatient prospective payment system.
These various sorts of recommendations may relate to such matters as product usage, dosage, and route of administration and use of related or competing therapies. Changes to these recommendations or other guidelines advocating alternative therapies could result in decreased use of ibrexafungerp and any future product candidates we may seek to develop, which may adversely affect our results of operations.
These various sorts of recommendations may relate to such matters as product usage, dosage, and route of administration and use of related or competing therapies. Changes to these recommendations or other guidelines advocating alternative therapies could result in decreased use of SCY-247 and any future product candidates we may seek to develop, which may adversely affect our results of operations.
The following factors, in addition to other factors described in this “Risk Factors” section and elsewhere in this report, may have a significant impact on the market price of our common stock: • the level of sales of BREXAFEMME; • the results of our preclinical testing or clinical trials; • the ability to obtain additional funding; • any delay in submitting an NDA or similar foreign applications for ibrexafungerp for the treatment of indications other than VVC, RVVC, and any future product candidate we may seek to develop or any adverse development or perceived adverse development with respect to the FDA’s review of that NDA or a foreign regulator’s review of a similar applications; • maintenance of our existing collaborations or ability to enter into new collaborations; • our collaboration partners’ election to develop or commercialize product candidates under our collaboration agreements or the termination of any programs under our collaboration agreements; • any intellectual property infringement actions in which we or our licensors and collaboration partners may become involved; • our ability to successfully develop and commercialize future product candidates; • changes in laws or regulations applicable to future products; • adverse regulatory decisions; • introduction of new products, services or technologies by our competitors; • achievement of financial projections we may provide to the public; • achievement of the estimates and projections of the investment community; • the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community; • changes in the structure of healthcare payment systems; • announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our collaboration partners or our competitors; • disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies; • legislation or regulation that mandates or encourages the use of generic products; • additions or departures of key scientific or management personnel; • significant lawsuits, including patent or stockholder litigation; • changes in the market valuations of similar companies; 42 • general economic and market conditions and overall fluctuations in the U.S. equity markets; • sales of our common stock by us, our executive officers and directors or our stockholders in the future; and • trading volume of our common stock.
The following factors, in addition to other factors described in this “Risk Factors” section and elsewhere in this report, may have a significant impact on the market price of our common stock: • the results of our preclinical testing or clinical trials; • the ability to obtain additional funding; 37 • any delay in submitting an NDA or similar foreign applications for SCY-247 and any future product candidate we may seek to develop or any adverse development or perceived adverse development with respect to the FDA’s review of that NDA or a foreign regulator’s review of a similar applications; • maintenance of our existing collaborations or ability to enter into new collaborations; • our collaboration partners’ election to develop or commercialize product candidates under our collaboration agreements or the termination of any programs under our collaboration agreements; • any intellectual property infringement actions in which we or our licensors and collaboration partners may become involved; • our ability to successfully develop and commercialize future product candidates; • changes in laws or regulations applicable to future products; • adverse regulatory decisions; • introduction of new products, services or technologies by our competitors; • achievement of financial projections we may provide to the public; • achievement of the estimates and projections of the investment community; • the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community; • changes in the structure of healthcare payment systems; • announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our collaboration partners or our competitors; • disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies; • legislation or regulation that mandates or encourages the use of generic products; • additions or departures of key scientific or management personnel; • significant lawsuits, including patent or stockholder litigation; • changes in the market valuations of similar companies; • general economic and market conditions and overall fluctuations in the U.S. equity markets; • sales of our common stock by us, our executive officers and directors or our stockholders in the future; and • trading volume of our common stock.
Any of these factors could result in delays or higher costs in connection with our clinical trials, regulatory submissions, required approvals or commercialization of ibrexafungerp and any future product candidates we may seek to develop. If we fail to establish or lose our relationships with CROs, our drug development efforts could be delayed.
Any of these factors could result in delays or higher costs in connection with our clinical trials, regulatory submissions, required approvals or commercialization of SCY-247 and any future product candidates we may seek to develop. If we fail to establish or lose our relationships with CROs, our drug development efforts could be delayed.
The FDA may hold us responsible for any deficiencies or noncompliance of our contract manufacturers in relation to ibrexafungerp and any other future product candidates we may seek to develop. Failure to follow cGMP can result in products being deemed adulterated, which carries significant legal implications.
The FDA may hold us responsible for any deficiencies or noncompliance of our contract manufacturers in relation to SCY-247 and any other future product candidates we may seek to develop. Failure to follow cGMP can result in products being deemed adulterated, which carries significant legal implications.
Also, any regulatory approval of a product candidate, once obtained, may be withdrawn. If ibrexafungerp or any of our other wholly-owned or partnered product candidates do not receive timely regulatory approval, or fail to maintain that regulatory approval, we may not be able to generate sufficient revenue to become profitable or to continue our operations.
Also, any regulatory approval of a product candidate, once obtained, may be withdrawn. If SCY-247 or any of our other wholly-owned or partnered product candidates do not receive timely regulatory approval, or fail to maintain that regulatory approval, we may not be able to generate sufficient revenue to become profitable or to continue our operations.
Consequently, we may be unable to successfully and efficiently execute and complete our ongoing and planned clinical trials in a way that is acceptable to the FDA and leads to an approval of additional indications for ibrexafungerp or any future product candidate we may seek to develop.
Consequently, we may be unable to successfully and efficiently execute and complete our ongoing and planned clinical trials in a way that is acceptable to the FDA and leads to an approval of additional indications for SCY-247 or any future product candidate we may seek to develop.
If we or any of our partners experience delays in the completion of, or if we or our partners terminate, clinical trials, the commercial prospects for ibrexafungerp and any future product candidates we may seek to develop will be harmed, and our ability to generate revenue from sales of these product candidates will be prevented or delayed.
If we or any of our partners experience delays in the completion of, or if we or our partners terminate, clinical trials, the commercial prospects for SCY-247 and any future product candidates we may seek to develop will be harmed, and our ability to generate revenue from sales of these product candidates will be prevented or delayed.
One or more strains of fungal pathogens may develop resistance to ibrexafungerp more rapidly than we currently expect, either because our hypothesis of the mechanism of action is incorrect or because a strain of fungi undergoes some unforeseen genetic mutation that permits it to survive.
One or more strains of fungal pathogens may develop resistance to SCY-247 more rapidly than we currently expect, either because our hypothesis of the mechanism of action is incorrect or because a strain of fungi undergoes some unforeseen genetic mutation that permits it to survive.
There are many foreign and domestic pharmaceutical companies, biotechnology companies, public and private universities, government agencies and research organizations actively engaged in research and development of products that may target the same markets as ibrexafungerp and any future product candidates we may seek to develop.
There are many foreign and domestic pharmaceutical companies, biotechnology companies, public and private universities, government agencies and research organizations actively engaged in research and development of products that may target the same markets as SCY-247 and any future product candidates we may seek to develop.
If we are unable to enter into any of these arrangements on acceptable terms, or at all, we may be unable to market and sell ibrexafungerp and any future product candidates we may seek to develop in certain markets. We expect to face competition in seeking appropriate collaborators.
If we are unable to enter into any of these arrangements on acceptable terms, or at all, we may be unable to market and sell SCY-247 and any future product candidates we may seek to develop in certain markets. We expect to face competition in seeking appropriate collaborators.
A successful product liability claim or series of claims brought against us, particularly if judgments exceed our insurance coverage, could decrease our cash available to develop ibrexafungerp and any future product candidates we may seek to develop and adversely affect our business.
A successful product liability claim or series of claims brought against us, particularly if judgments exceed our insurance coverage, could decrease our cash available to develop SCY-247 and any future product candidates we may seek to develop and adversely affect our business.
Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance in the United States for BREXAFEMME, ibrexafungerp, and any future product candidates we may seek to develop. If there is not sufficient reimbursement for our products, it is less likely that our products will be purchased by patients and/or providers.
Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance in the United States for SCY-247 and any future product candidates we may seek to develop. If there is not sufficient reimbursement for our products, it is less likely that our products will be purchased by patients and/or providers.
Any threatened or actual government enforcement action could also generate adverse publicity and require that we devote substantial resources that could otherwise be used in other aspects of our business. Regulations, 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.
Any threatened or actual government enforcement action could also generate adverse publicity and require that we devote substantial resources that could otherwise be used in other aspects of our business. 27 Regulations, 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.
Risks Relating to the Development, Regulatory Approval and Commercialization of Our Product Candidates For Human Use We cannot be certain that ibrexafungerp will receive regulatory approval in the additional indications we are pursuing, and without regulatory approval it will not be possible to market ibrexafungerp for these indications.
Risks Relating to the Development, Regulatory Approval and Commercialization of Our Product Candidates For Human Use We cannot be certain that SCY-247 will receive regulatory approval in the additional indications we are pursuing, and without regulatory approval it will not be possible to market SCY-247 for these indications.
As such, coverage and adequate reimbursement from third-party payors can be essential to new product acceptance and may have an effect on pricing. We do not know the extent to which BREXAFEMME will be able to obtain favorable coverage and adequate reimbursement from third-party payors.
As such, coverage and adequate reimbursement from third-party payors can be essential to new product acceptance and may have an effect on pricing. We do not know the extent to which SCY-247 will be able to obtain favorable coverage and adequate reimbursement from third-party payors.
If we choose to bring other product candidates to market, they will be subject to similar uncertainty. We believe that ibrexafungerp and any other product candidates that are brought to market are less likely to be purchased by patients and/or providers if they are not adequately reimbursed by third-party payors.
If we choose to bring other product candidates to market, they will be subject to similar uncertainty. We believe that SCY-247 and any other product candidates that are brought to market are less likely to be purchased by patients and/or providers if they are not adequately reimbursed by third-party payors.
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.
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.
Diagnostic tools recently approved by the FDA, or currently under development, for the rapid diagnosis of invasive fungal infections may significantly diminish the need to treat patients in advance of diagnosis of invasive fungal infections, which will reduce the potential market for ibrexafungerp.
Diagnostic tools recently approved by the FDA, or currently under development, for the rapid diagnosis of invasive fungal infections may significantly diminish the need to treat patients in advance of diagnosis of invasive fungal infections, which will reduce the potential market for SCY-247.
If we are unable to retain our current executive officers and key employees our ability to implement our business strategy successfully could be seriously harmed. We may need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth. As of March 1, 2025, we had 28 full time employees.
If we are unable to retain our current executive officers and key employees our ability to implement our business strategy successfully could be seriously harmed. We may need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth. As of March 1, 2026, we had 18 full time employees.
If we are required to conduct additional clinical trials or other testing of ibrexafungerp or any future product candidates we may seek to develop, we may be delayed in obtaining, or may not be able to obtain, marketing approval for these product candidates.
If we are required to conduct additional clinical trials or other testing of SCY-247 or any future product candidates we may seek to develop, we may be delayed in obtaining, or may not be able to obtain, marketing approval for these product candidates.
Delays 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.
Delays 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.
If we do receive approval in other countries, we may enter into sales and marketing arrangements with third parties for international sales of any approved products. BREXAFEMME, ibrexafungerp, or any other future product candidates we may seek to develop, may still face future development and regulatory difficulties.
If we do receive approval in other countries, we may enter into sales and marketing arrangements with third parties for international sales of any approved products. SCY-247 or any other future product candidates we may seek to develop, may still face future development and regulatory difficulties.
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 ibrexafungerp. If we experience problems with any of these third parties, the commercial manufacturing of ibrexafungerp could be delayed.
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.
BREXAFEMME, ibrexafungerp, and any other future product candidates we may seek to develop will also be subject to ongoing regulatory requirements for the packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information on the drug.
SCY-247 and any other future product candidates we may seek to develop will also be subject to ongoing regulatory requirements for the packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information on the drug.
In addition, failure to commence or complete, or delays in, our planned clinical trials would prevent us from or delay us in commercializing ibrexafungerp or any future product candidate we may develop.
In addition, failure to commence or complete, or delays in, our planned clinical trials would prevent us from or delay us in commercializing SCY-247 or any future product candidate we may develop.
For BREXAFEMME, ibrexafungerp, or any other future product candidates we may seek to develop, regulatory authorities may still impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies.
For SCY-247 or any other future product candidates we may seek to develop, regulatory authorities may still impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies.
As a result, with respect to Medicare reimbursement for services in the hospital inpatient setting, hospitals could have a financial incentive to use the least expensive drugs for the treatment of invasive fungal infections, particularly the IV formulations of these drugs, as they are typically administered in the hospital, which may significantly impact our ability to charge a premium for ibrexafungerp.
As a result, with respect to Medicare reimbursement for services in the hospital inpatient setting, hospitals could have a financial incentive to use the 23 least expensive drugs for the treatment of invasive fungal infections, particularly the intravenous formulations of these drugs, as they are typically administered in the hospital, which may significantly impact our ability to charge a premium for SCY-247.
If ibrexafungerp or any future product candidates are found to be unsafe or lack efficacy, we or our collaborators will not be able to obtain regulatory approval for them and our business would be harmed.
If SCY-247 or any future product candidates are found to be unsafe or lack efficacy, we or our potential collaborators will not be able to obtain regulatory approval for them and our business would be harmed.
The following factors relating to our business, as well as factors described elsewhere in this report, may contribute to these fluctuations: • the costs associated with completing the ongoing and anticipated clinical studies for ibrexafungerp and SCY-247, which are difficult for us to predict, including the potential costs associated with the anticipated resumption of the Phase 3 MARIO study if the clinical hold is lifted; • any delays in regulatory review and approval of ibrexafungerp; • delays in the timing of submission of any new drug application, or NDA, or supplement thereto, as well as commencement, enrollment and the timing of clinical testing, of any product candidates we may seek to develop; • market acceptance of BREXAFEMME and any future product candidates for which we obtain FDA approval; 20 • changes in regulations and regulatory policies; • competition from existing products or new products that may emerge; • the ability of patients or healthcare providers to obtain coverage of, or sufficient reimbursement for, any products we are able to develop; • our ability to establish or maintain collaborations, licensing or other arrangements; • costs related to, and outcomes of, potential litigation; • potential product liability claims; and • potential liabilities associated with hazardous materials.
The following factors relating to our business, as well as factors described elsewhere in this report, may contribute to these fluctuations: • the costs associated with completing the ongoing and anticipated clinical studies for SCY-247, which are difficult for us to predict; • any delays in regulatory review and approval of SCY-247; • delays in the timing of submission of any new drug application, or NDA, or supplement thereto, as well as commencement, enrollment and the timing of clinical testing, of any product candidates we may seek to develop; • market acceptance of any future product candidates for which we obtain FDA approval; • changes in regulations and regulatory policies; • competition from existing products or new products that may emerge; • the ability of patients or healthcare providers to obtain coverage of, or sufficient reimbursement for, any products we are able to develop; • our ability to establish or maintain collaborations, licensing or other arrangements; • costs related to, and outcomes of, potential litigation; 17 • potential product liability claims; and • potential liabilities associated with hazardous materials.
We do not know whether future changes to the regulatory environment will be favorable or unfavorable to our business prospects. 24 If 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.
We do not know whether future changes to the regulatory environment will be favorable or unfavorable to our business prospects. If 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.
Further, as we advance ibrexafungerp and SCY-247 through clinical studies, clinical trials and commercialization for other indications, we will need to increase our product development, scientific, marketing, sales and administrative headcount to manage these efforts. Our management, personnel and systems currently in place may not be adequate to support this future growth.
Further, as we advance SCY-247 through clinical studies, we will need to increase our product development, scientific, marketing, sales and administrative headcount to manage these efforts. Our management, personnel and systems currently in place may not be adequate to support this future growth.
Regulatory 21 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.
Regulatory approval is a lengthy, expensive and uncertain process and there is no guarantee that SCY-247 will be approved by the FDA for the additional indications we are pursuing.
If BREXAFEMME, or ibrexafungerp for other indications or any future product candidates we may seek to develop are approved, but do not achieve an adequate level of acceptance by physicians, healthcare payors and patients, sufficient revenue may not be generated from these product candidates, and we may not become or remain profitable.
If SCY-247 or any future product candidates we may seek to develop are approved, but do not achieve an adequate level of acceptance by physicians, healthcare payors and patients, sufficient revenue may not be generated from these product candidates, and we may not become or remain profitable.
Although we believe these provisions together provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our board of directors, they would apply even if the offer may be considered beneficial by some stockholders. ITEM 1B. UNRESOLV ED STAFF COMMENTS None.
Although we believe these provisions together provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our board of directors, they would apply even if the offer may be considered beneficial by some stockholders.
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. The pharmaceutical industry is highly competitive, with a number of established, large pharmaceutical companies, as well as many smaller companies.
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. The pharmaceutical industry is highly competitive, with a number of established, large pharmaceutical companies, as well as many smaller companies.
We 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. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive.
We 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. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive.
The commercial success of BREXAFEMME, ibrexafungerp for other indications or any other product candidates we may seek to develop will depend upon the acceptance of these product candidates among physicians, patients, the medical community and healthcare payors.
The commercial success of SCY-247 or any other product candidates we may seek to develop will depend upon the acceptance of these product candidates among physicians, patients, the medical community and healthcare payors.
Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for BREXAFEMME or other products for which the Company receives regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for SCY-247 or other products for which the we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
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.
Risks 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.
Obtaining approval of an NDA is a lengthy, expensive and uncertain process. An NDA must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and effectiveness for each indication. The approval application must also include significant information regarding the chemistry, manufacturing and controls for the product.
An NDA must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and effectiveness for each indication. The approval application must also include significant information regarding the chemistry, manufacturing and controls for the product.
For example, BREXAFEMME competes, and ibrexafungerp for other indications will compete, against current leading antifungal drugs, including voriconazole from the azole class, caspofungin 26 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.
For example, SCY-247 will compete against current leading antifungal drugs, including voriconazole from the azole class, caspofungin 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 the intravenous formulation of SCY-247 might be approved.
During times of war and other major conflicts, we and the third parties upon which we rely may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our services. 40 We and the third parties upon which we rely are subject to a variety of evolving threats, including but not limited to social-engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, credential stuffing attacks, credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, attacks enhanced or facilitated by AI, telecommunications failures, earthquakes, fires, floods, and other similar threats.
We and the third parties upon which we rely are subject to a variety of evolving threats, including but not limited to social-engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, credential stuffing attacks, credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, attacks enhanced or facilitated by AI, telecommunications failures, earthquakes, fires, floods, and other similar threats.
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. 30 HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their implementing regulations, which impose certain obligations with respect to safeguarding the privacy, security and transmission of individually identifiable health information on “covered entities,” such as certain healthcare providers, health plans, and healthcare clearinghouses and their respective “business associates,” as well as their covered subcontractors, that perform services for them, which involve the creation, receipt, use, maintenance, transmission or disclosure of, individually identifiable health information for or on behalf of a covered entity.
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their implementing regulations, which impose certain obligations with respect to safeguarding the privacy, security and transmission of individually identifiable health information on “covered entities,” such as certain healthcare providers, health plans, and healthcare clearinghouses and their respective “business associates,” as well as their covered subcontractors, that perform services for them, which involve the creation, receipt, use, maintenance, transmission or disclosure of, individually identifiable health information for or on behalf of a covered entity.
Preparing for and complying with these obligations requires us to devote significant resources and may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf.
Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. Preparing for and complying with these obligations requires us to devote significant resources and may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf.
Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash position and results of operations. 38 Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing.
Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash position and results of operations. Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing. Certain laws and regulations require us to test our product candidates on animals before initiating clinical trials involving humans.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeDepending on the environment, systems, and data, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example: an incident response process; disaster recovery/business 43 continuity plans; encrypting certain data; using network security controls; maintaining access controls; managing assets; and maintaining cybersecurity insurance.
Biggest changeWe identify and assess risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods including: manual and automated tools; subscribing to and analyzing reports and services that identify cybersecurity threats; evaluating threats reported to us; and conducting vulnerability assessments. 39 Depending on the environment, systems, and data, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example: an incident response process; disaster recovery/business continuity plans; encrypting certain data; using network security controls; maintaining access controls; managing assets; and maintaining cybersecurity insurance.
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We identify and assess risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods including: manual and automated tools; subscribing to and analyzing reports and services that identify cybersecurity threats; evaluating threats reported to us; and conducting vulnerability assessments.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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LEGAL PROCEEDINGS On November 7, 2023, a securities class action was filed by Brian Feldman against us and certain of our executives in the United States District Court, District of New Jersey, alleging that, during the period from March 31, 2023 to September 22, 2023, we made materially false and/or misleading statements, as well as failed to disclose material adverse facts about our business, operations, and prospects, alleging specifically that we failed to disclose to investors: (1) that the equipment used to manufacture ibrexafungerp was also used to manufacture a non-antibacterial beta-lactam drug substance, presenting a risk of cross-contamination; (2) that we did not have effective internal controls and procedures, as well as adequate internal oversight 44 policies to ensure that its vendor complied with current Good Manufacturing Practices (cGMP); (3) that, due to the substantial risk of cross-contamination, we were reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies; and (4) as a result of the foregoing, our statements about our business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
Added
ITEM 3. LEGAL PROCEEDINGS The information called for by this Item is incorporated herein by reference to Note 6 included in Part 2, Item 8, Consolidated Financial Statements and Supplementary Data — Notes to the Consolidated Financial Statements . 40 ITEM 4. MINE SAF ETY DISCLOSURES Not applicable. 41 PART II
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The complaint seeks unspecified damages, interest, fees and costs on behalf of all persons and entities who purchased and/or acquired shares of our common stock between March 31, 2023 to September 22, 2023. We have filed a motion to dismiss.
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On May 1, 2024, and again on June 4, 2024, purported shareholder derivative complaints were filed in the United States District Court, District of New Jersey. The complaints name our directors and certain of our officers and assert state and federal claims based on the same alleged misstatements as the securities class action complaint.
Removed
These cases were consolidated and are currently stayed. We disagree with the allegations and we intend to defend these litigations vigorously . ITEM 4. MINE SAF ETY DISCLOSURES Not applicable. 45 PART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures 45 PART II. 46 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 46 Item 6. [Reserved] 46 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 47 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 56 Item 8.
Biggest changeItem 4. Mine Safety Disclosures 41 PART II. 42 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 42 Item 6. [Reserved] 42 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 43 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 51 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeMARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock trades on the Nasdaq Global Market under the symbol “SCYX.” Stockholders As of March 1, 2025, there were approximately 43 stockholders of record of our common stock, which excludes stockholders whose shares were held in nominee or street name by brokers.
Biggest changeMARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock trades on the Nasdaq Capital Market under the symbol “SCYX.” Stockholders As of March 1, 2026, there were approximately 42 stockholders of record of our common stock, which excludes stockholders whose shares were held in nominee or street name by brokers.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers We did not purchase any of our securities during the fourth quarter of 2024.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers We did not purchase any of our securities during the fourth quarter of 2025.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

46 edited+30 added−49 removed35 unchanged
Biggest changeResults of Operations for the Years Ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023, and period-to-period percentage change (dollars in thousands): 50 Years Ended December 31, 2024 2023 Period-to-Period Change Revenue: Product revenue, net $ — $ 1,044 (1,044 ) (100.0 )% License agreement revenue 3,746 139,097 (135,351 ) (97.3 %) Total revenue 3,746 140,141 (136,395 ) (97.3 %) Operating expenses: Cost of product revenue — 15,624 (15,624 ) (100.0 %) Research and development 26,405 30,928 (4,523 ) (14.6 )% Selling, general and administrative 14,458 20,920 (6,462 ) (30.9 )% Total operating expenses 40,863 67,472 (26,609 ) (39.4 )% (Loss) income from operations (37,117 ) 72,669 (109,786 ) (151.1 )% Other expense (income): Amortization of debt issuance costs and discount 1,726 2,994 (1,268 ) (42.4 )% Interest income (4,291 ) (3,954 ) (337 ) 8.5 % Interest expense 828 3,130 (2,302 ) (73.5 )% Other income (235 ) — (235 ) — Warrant liabilities fair value adjustment (13,812 ) 3,166 (16,978 ) (536.3 )% Derivative liabilities fair value adjustment (196 ) 154 (350 ) (227.3 )% Total other (income) expense (15,980 ) 5,490 (21,470 ) (391.1 )% (Loss) income before taxes (21,137 ) 67,179 (88,316 ) (131.5 )% Income tax (expense) (151 ) (138 ) (13 ) 9.4 % Net (loss) income $ (21,288 ) $ 67,041 $ (88,329 ) (131.8 )% Revenue.
Biggest changeResults of Operations for the Years Ended December 31, 2025 and 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and 2024, and period-to-period percentage change (dollars in thousands): 45 Years Ended December 31, 2025 2024 Period-to-Period Change Revenue: Product revenue, net $ 1,444 $ — $ 1,444 — License agreement revenue 19,157 3,746 15,411 411.4 % Total revenue 20,601 3,746 16,855 449.9 % Operating expenses: Research and development 22,280 26,405 (4,125 ) (15.6 )% Selling, general and administrative 14,395 14,458 (63 ) (0.4 )% Total operating expenses 36,675 40,863 (4,188 ) (10.2 )% Loss from operations (16,074 ) (37,117 ) 21,043 (56.7 )% Other expense (income): Amortization of debt issuance costs and discount 312 1,726 (1,414 ) (81.9 )% Interest income (2,177 ) (4,291 ) 2,114 (49.3 )% Interest expense 173 828 (655 ) (79.1 )% Other income — (235 ) 235 (100.0 )% Warrant liability fair value adjustment (5,773 ) (13,812 ) 8,039 (58.2 )% Derivative liability fair value adjustment — (196 ) 196 (100.0 )% Total other income (7,465 ) (15,980 ) 8,515 (53.3 )% Loss before taxes (8,609 ) (21,137 ) 12,528 (59.3 )% Income tax expense — (151 ) 151 (100.0 )% Net loss $ (8,609 ) $ (21,288 ) $ 12,679 (59.6 )% Revenue.
Financing Activities Net cash used in financing activities of $0.1 million for the year ended December 31, 2024, consisted primarily of the $0.2 million in payments of offering costs in the year ended December 31, 2024.
Net cash used in financing activities of $0.1 million for the year ended December 31, 2024, consisted primarily of the $0.2 million in payments of offering costs in the year ended December 31, 2024.
Our research and development expense primarily consists of: 49 • costs related to executing preclinical studies and clinical trials, including development milestones, drug formulation, manufacturing and other development; • salaries and personnel-related costs, including benefits and any stock-based compensation for personnel performing research and development functions; • fees paid to clinical research organizations (CROs), vendors, consultants and other third parties who support our product candidate development; • medical affairs related expense and salary that is incurred to discover, develop, or improve potential product candidates; • other costs in seeking regulatory approval of our products; and • allocated overhead.
Our research and development expense primarily consists of: • costs related to executing preclinical studies and clinical trials, including development milestones, drug formulation, manufacturing and other development; • salaries and personnel-related costs, including benefits and any stock-based compensation for personnel performing research and development functions; • fees paid to clinical research organizations (CROs), vendors, consultants and other third parties who support our product candidate development; • medical affairs related expense and salary that is incurred to discover, develop, or improve potential product candidates; • other costs in seeking regulatory approval of our products; and • allocated overhead.
The net favorable change in operating assets and liabilities of $7.3 million is due to a favorable change of $15.0 million due to the decrease in operating assets, offset by an unfavorable change of $7.7 million due to the decrease in operating liabilities The net $15.0 million decrease in operating assets is primarily due to a decrease of $9.9 million in the license agreement contract asset given the receipt of the $10.0 million development milestone associated with the GSK License Agreement in the year ended December 31, 2024, a $1.7 million decrease in the license agreement receivable associated with the GSK License Agreement which was collected in the year ended December 31, 2024, and a $3.4 million decrease in prepaid expenses, other assets, deferred costs, and other.
The net favorable change in operating assets and liabilities of $7.3 million is due to a favorable change of $15.0 million due to the decrease in operating assets, offset by an unfavorable change of $7.7 million due to the decrease in 47 operating liabilities The net $15.0 million decrease in operating assets is primarily due to a decrease of $9.9 million in the license agreement contract asset given the receipt of the $10.0 million development milestone associated with the GSK License Agreement in the year ended December 31, 2024, a $1.7 million decrease in the license agreement receivable associated with the GSK License Agreement which was collected in the year ended December 31, 2024, and a $3.4 million decrease in prepaid expenses, other assets, deferred costs, and other.
In applying these assumptions, we considered the following factors: 55 • we estimate expected volatility based on the volatility of our own common stock trading history and implied volatility; • the assumed dividend yield is based on our expectation of not paying dividends on our underlying common stock for the foreseeable future; • we determine the average expected life of stock options based on the simplified method in accordance with SEC Staff Accounting Bulletin Nos. 107 and 110.
In applying these assumptions, we considered the following factors: • we estimate expected volatility based on the volatility of our own common stock trading history and implied volatility; • the assumed dividend yield is based on our expectation of not paying dividends on our underlying common stock for the foreseeable future; • we determine the average expected life of stock options based on the simplified method in accordance with SEC Staff Accounting Bulletin Nos. 107 and 110.
If we raise additional funds through sales of assets, other third-party funding, strategic alliances and licensing or collaboration arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.
If we raise additional funds through sales 48 of assets, other third-party funding, strategic alliances and licensing or collaboration arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.
We are continually evaluating our operating plan and assessing the optimal cash utilization for our SCY-247 and ibrexafungerp development strategy. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect.
We are continually evaluating our operating plan and assessing the optimal cash utilization for our SCY-247 development strategy. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect.
In arrangements that include the sale or license of intellectual property and other promised services, we first identify if the licenses are distinct from the 54 other promises in the arrangement. If the license is not distinct, the license is combined with other services into a single performance obligation.
In arrangements that include the sale or license of intellectual property and other promised services, we first identify if the licenses are distinct from the other promises in the arrangement. If the license is not distinct, the license is combined with other services into a single performance obligation.
For the year ended December 31, 2024, we recognized $0.2 million in other income associated with certain research and development tax credits. Warrant Liabilities Fair Value Adjustment .
For the year ended December 31, 2024, we recognized $0.2 million in other income associated with certain research and development tax credits. 46 Warrant Liabilities Fair Value Adjustment .
While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements for the year ended December 31, 2024, included in this Annual Report, we believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our consolidated financial statements and understanding and evaluating our reported financial results.
While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements for the year ended December 31, 2025, included in this Annual Report, we believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our consolidated financial statements and understanding and evaluating our reported financial results.
Revenue Recognition License Agreement Revenue We have entered into arrangements involving the sale or license of intellectual property and the provision of other services.
License Agreement Revenue We have entered into arrangements involving the sale or license of intellectual property and the provision of other services.
We assessed the terms of the GSK License Agreement and identified the following performance obligations which include: (1) the license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, in the GSK Territory, (2) the research and development activities for the MARIO study, and (3) performance obligations for the remaining research and development activities for the ongoing clinical and preclinical studies of ibrexafungerp.
We assessed the terms of the GSK License Agreement and identified the following performance obligations which included: (1) the license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, in the GSK Territory, (2) the research and development activities for the MARIO study, and (3) performance obligations for the remaining research and development activities for the ongoing clinical and preclinical studies of ibrexafungerp.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Operating results for the year ended December 31, 2024, are not necessarily indicative of results that may occur in future fiscal years. Some of the statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are forward-looking statements.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Operating results for the year ended December 31, 2025, are not necessarily indicative of results that may occur in future fiscal years. Some of the statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are forward-looking statements.
Research and Development Accruals We are required to estimate our expenses resulting from our obligations under contracts with CROs, clinical site agreements, vendors, and consultants in connection with conducting ibrexafungerp clinical trials and preclinical studies and other development activities.
Research and Development Accruals We are required to estimate our expenses resulting from our obligations under contracts with CROs, clinical site agreements, vendors, and consultants in connection with conducting SCY-247 and ibrexafungerp clinical trials and preclinical studies and other development activities.
For the years ended December 31, 2024 and 2023, we recognized $1.7 million and $3.0 million in amortization of debt issuance costs and discount, respectively.
For the years ended December 31, 2025 and 2024, we recognized $0.3 million and $1.7 million in amortization of debt issuance costs and discount, respectively.
Our future capital requirements will depend on many factors, including: • our ability to successfully achieve the development, regulatory, and commercial milestones under our GSK License Agreement; 53 • the progress, costs, and the clinical and preclinical research and development of ibrexafungerp and SCY-247; • the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; • the ability of our product candidates to progress through clinical development successfully; • our need to expand our research and development activities; • the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities; • our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; • our need and ability to hire additional management and scientific and medical personnel; • our need to implement additional, as well as to enhance existing, internal systems and infrastructure, including financial and reporting processes and systems; and • the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.
Our future capital requirements will depend on many factors, including: • the progress, costs, and the clinical and preclinical research and development of SCY-247; • the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; • the ability of our product candidates to progress through clinical development successfully; • our need to expand our research and development activities; • the costs associated with securing, establishing and maintaining manufacturing capabilities; • our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; • our need and ability to hire additional management and scientific and medical personnel; • our need to implement additional, as well as to enhance existing, internal systems and infrastructure, including financial and reporting processes and systems; and • the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.
We believe our capital resources are sufficient to fund our on-going operations for a period of at least 12 months subsequent to the issuance of the accompanying consolidated financial statements. As of December 31, 2024, our accumulated deficit was $376.5 million. We anticipate that we will continue to incur losses for at least the next several years.
We believe our capital resources are sufficient to fund our on-going operations for a period of at least 12 months subsequent to the issuance of the accompanying consolidated financial statements. As of December 31, 2025, our accumulated deficit was $385.1 million. We anticipate that we will continue to incur losses for at least the next several years.
Income Tax Expense For the years ended December 31, 2024 and 2023, our income tax expense recognized consists primarily of income tax expense for U.S. federal and state income taxes.
Income Tax Expense For the year ended December 31, 2024, our income tax expense recognized consists primarily of income tax expense for U.S. federal and state income taxes.
Ibrexafungerp and SCY-247 were the only key research and development projects during the periods presented. We expect to continue to incur significant research and development expense for the foreseeable future as we continue our effort to develop ibrexafungerp and SCY-247, and to potentially develop our other product candidates, subject to the availability of additional funding.
SCY-247 and ibrexafungerp as part of the MARIO Phase 3 study were the key research and development projects during the periods presented. We expect to continue to incur significant research and development expense for the foreseeable future as we continue our effort to develop SCY-247, and to potentially develop our other product candidates, subject to the availability of additional funding.
At December 31, 2024, the Level 3 volatility utilized in the Black-Scholes model to fair value the April 2022 public offering warrants was 83.4%. See Note 2 to our consolidated financial statements on this Annual Report for further details.
At December 31, 2025, the Level 3 volatility utilized in the Black-Scholes model to fair value the April 2022 public offering warrants was 86.1%. See Note 2 to our consolidated financial statements on this Annual Report for further details.
The assumptions used in the Black-Scholes option-pricing model for the years ended December 31, 2024 and 2023 are set forth below: Employee Stock Options Years Ended December 31, 2024 2023 Weighted average risk-free interest rate 4.04 % 3.98 % Weighted average expected term (in years) 6.02 6.04 Weighted average expected volatility 80.94 % 74.77 % Non-Employee Stock Options Years Ended December 31, 2024 2023 Weighted average risk-free interest rate 4.26 % 3.89 % Weighted average expected term (in years) 5.50 5.50 Weighted average expected volatility 83.83 % 80.12 % We record the fair value of stock options issued as of the grant date as compensation expense.
The assumptions used in the Black-Scholes option-pricing model for the years ended December 31, 2025 and 2024 are set forth below: Employee Stock Options Years Ended December 31, 2025 2024 Weighted average risk-free interest rate 4.50 % 4.04 % Weighted average expected term (in years) 6.02 6.02 Weighted average expected volatility 81.15 % 80.94 % Non-Employee Stock Options Years Ended December 31, 2025 2024 Weighted average risk-free interest rate 3.84 % 4.26 % Weighted average expected term (in years) 5.50 5.50 Weighted average expected volatility 82.55 % 83.83 % We record the fair value of stock options issued as of the grant date as compensation expense.
Stock-based compensation expense has been reported in our statements of operations as follows (dollars in thousands): Years Ended December 31, 2024 2023 Research and development $ 988 $ 873 Selling, general and administrative 2,358 1,751 Total $ 3,346 $ 2,624 On December 31, 2024, the aggregate intrinsic value of outstanding options to purchase shares of our common stock was zero, based upon the $1.21 closing sales price per share of our common stock as reported on the Nasdaq Global Market on that date.
Stock-based compensation expense has been reported in our statements of operations as follows (dollars in thousands): Years Ended December 31, 2025 2024 Research and development $ 514 $ 988 Selling, general and administrative 2,338 2,358 Total $ 2,852 $ 3,346 On December 31, 2025, the aggregate intrinsic value of outstanding options to purchase shares of our common stock was zero, based upon the $0.63 closing sales price per share of our common stock as reported on the Nasdaq Capital Market on that date.
The debt issuance costs and discount for our March 2019 convertible notes primarily consisted of an allocated portion of advisory fees and other issuance costs and the initial fair value of the derivative liability. Interest Income.
The debt issuance costs and discount for our March 2019 convertible notes, which were fully paid at maturity in March 2025, primarily consisted of an allocated portion of advisory fees and other issuance costs and the initial fair value of the derivative liability. Interest Income.
Warrant Liabilities We account for the outstanding warrants associated with the December 2020 and April 2022 public offerings as liabilities measured at fair value. The fair values of these warrants have been determined using the Black-Scholes valuation model. We determine the risk-free interest rate by reference to implied yields available from U.S.
Warrant Liability 50 We account for the outstanding warrants associated with the April 2022 public offering as a liability measured at fair value. The fair value of these warrants has been determined using the Black-Scholes valuation model. We determine the risk-free interest rate by reference to implied yields available from U.S.
For the years ended December 31, 2024 and 2023, we recognized a gain of $13.8 million and a loss of $3.2 million, respectively, for the fair value adjustment for warrant liabilities primarily due to the decrease and increase in our stock price during the periods, respectively. Derivative Liabilities Fair Value Adjustment.
For the years ended December 31, 2025 and 2024, we recognized gains of $5.8 million and $13.8 million, respectively, for the fair value adjustment for warrant liabilities primarily due to the decrease in our stock price during the periods, respectively. Derivative Liabilities Fair Value Adjustment.
The $0.7 million increase in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247. Selling, General and Administrative . For the year ended December 31, 2024, selling, general and administrative expenses decreased to $14.5 million from $20.9 million for the year ended December 31, 2023.
The $1.2 million increase in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247 in the current period. Selling, General and Administrative . For the year ended December 31, 2025, selling, general and administrative expenses decreased to $14.4 million from $14.5 million for the year ended December 31, 2024.
For the years ended December 31, 2024 and 2023, we recognized a gain of $0.2 million and a loss of $0.2 million, respectively, in the fair value adjustment related to the derivative liability primarily due to the decrease and increase in our stock price during the periods, respectively. Income Tax Expense.
For the year ended December 31, 2024, we recognized a gain of $0.2 million in the fair value adjustment related to the derivative liability primarily due to the decrease in our stock price during the period. Income Tax Expense. For the year ended December 31, 2024, we recognized $0.2 million in income tax expense primarily for U.S. federal income tax.
The decrease of $4.5 million, or 14.6%, was primarily driven by a decrease of $7.4 million in clinical expense, a decrease of $1.3 million in salary expense primarily associated with medical affairs, and a net decrease in other research and development expense of $0.4 million, offset in part by an increase of $3.9 million in chemistry, manufacturing, and controls (CMC) expense, and an increase of $0.7 million in preclinical expense.
The decrease of $4.1 million, or 15.6%, was primarily driven by a decrease of $3.8 million in chemistry, manufacturing, and controls (CMC) expense, a decrease of $1.0 million in salary expense, a $0.5 million decrease in stock-based compensation and a net decrease in other research and development expense of $0.5 million, offset in part by an increase of $1.2 million in preclinical expense and a $0.5 million increase in clinical expense.
Investing Activities Net cash provided by investing activities of $6.2 million for the year ended December 31, 2024, consisted of purchases of $36.4 million and maturities of $42.6 million in investments. Net cash used in investing activities of $34.9 million for the year ended December 31, 2023, consisted of purchases of $85.5 million and maturities of $50.6 million in investments.
Investing Activities Net cash provided by investing activities of $24.3 million for the year ended December 31, 2025, consisted of purchases of $18.9 million and maturities of $43.2 million in investments. Net cash provided by investing activities of $6.2 million for the year ended December 31, 2024, consisted of purchases of $36.4 million and maturities of $42.6 million in investments.
These and many other factors could affect our future financial and operating results. We undertake no obligation to update any forward-looking statement to reflect events after the date of this Annual Report. Overview SCYNEXIS, Inc. is pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections.
These and many other factors could affect our future financial and operating results. We undertake no obligation to update any forward-looking statement to reflect events after the date of this Annual Report. Overview SCYNEXIS, Inc. is dedicated to advancing innovative solutions for severe rare diseases, with our lead program in the treatment and prevention of difficult-to-treat and drug-resistant fungal infections.
Net cash provided by operating activities of $60.2 million for the year ended December 31, 2023, primarily consisted of the $67.0 million net income adjusted for non-cash charges that included the loss on change in fair value of the warrant liabilities of $3.2 million, stock-based compensation expense of $2.6 million, accretion of investment discount of $1.3 million, the loss on change in fair value of the derivative liability of $0.2 million, and the amortization of debt issuance costs and discount of $3.0 million, plus a net unfavorable change in operating assets and liabilities of $30.6 million.
Net cash used in operating activities of $24.0 million for the year ended December 31, 2024, primarily consisted of the $21.3 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant liabilities of $13.8 million, stock-based compensation expense of $3.3 million, accretion of investment discount of $1.3 million, and the amortization of debt issuance costs and discount of $1.7 million, plus a net favorable change in operating assets and liabilities of $7.3 million.
Cash Flows The following table sets forth the significant sources and uses of cash for the years ended December 31, 2024 and 2023 (dollars in thousands): Years Ended December 31, 2024 2023 Cash, cash equivalents, and restricted cash, January 1 $ 34,593 $ 46,032 Net cash (used in) provided by operating activities (24,009 ) 60,159 Net cash provided by (used in) investing activities 6,150 (34,877 ) Net cash used in financing activities (139 ) (36,721 ) Net decrease in cash, cash equivalents, and restricted cash (17,998 ) (11,439 ) Cash, cash equivalents, and restricted cash, December 31 $ 16,595 $ 34,593 Operating Activities The $84.2 million decrease in net cash (used in) provided by operating activities for the year ended December 31, 2024, as compared to the year ended December 31, 2023, was primarily due to the $115.0 million in upfront and development milestones received under the GSK License Agreement in the prior period and the continued development costs associated with SCY-247 and ibrexafungerp in the year ended December 31, 2024, offset in part by the $10.0 million development milestone received under the GSK License Agreement in the year ended December 31, 2024. 52 Net cash used in operating activities of $24.0 million for the year ended December 31, 2024, primarily consisted of the $21.3 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant liabilities of $13.8 million, stock-based compensation expense of $3.3 million, accretion of investment discount of $1.3 million, and the amortization of debt issuance costs and discount of $1.7 million, plus a net favorable change in operating assets and liabilities of $7.3 million.
Cash Flows The following table sets forth the significant sources and uses of cash for the years ended December 31, 2025 and 2024 (dollars in thousands): Years Ended December 31, 2025 2024 Cash, cash equivalents, and restricted cash, January 1 $ 16,595 $ 34,593 Net cash used in operating activities (5,283 ) (24,009 ) Net cash provided by investing activities 24,306 6,150 Net cash used in financing activities (14,170 ) (139 ) Net increase (decrease) in cash, cash equivalents, and restricted cash 4,853 (17,998 ) Cash, cash equivalents, and restricted cash, December 31 $ 21,448 $ 16,595 Operating Activities The $18.7 million decrease in net cash used in operating activities for the year ended December 31, 2025, as compared to the year ended December 31, 2024, was primarily due to the $24.8 million we received under the Binding 2025 MOU in the year ended December 31, 2025, offset by the continued development costs associated with SCY-247 and ibrexafungerp, Net cash used in operating activities of $5.3 million for the year ended December 31, 2025, primarily consisted of the $8.6 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant liabilities of $5.8 million, stock-based compensation expense of $2.9 million, plus a net favorable change in operating assets and liabilities of $6.1 million.
For the years ended December 31, 2024 and 2023, we recognized $4.3 million and $4.0 million, respectively, in interest income associated with our money market accounts and investments. The increase was primarily due to the interest income being earned on our money market funds and investments for the full period in 2024. Interest Expense.
For the years ended December 31, 2025 and 2024, we recognized $2.2 million and $4.3 million, respectively, in interest income associated with our money market accounts and investments. Interest Expense.
Research and Development Expense Research and development expense consists of expenses incurred while performing research and development activities to discover, develop, or improve potential product candidates we seek to develop. This includes conducting preclinical studies and clinical trials, manufacturing and other development efforts, and activities related to regulatory filings for product candidates.
This includes conducting preclinical studies and clinical trials, manufacturing and other development efforts, and activities related to regulatory filings for product candidates. 44 We recognize research and development expenses as they are incurred.
For clinical trials, we account for these expenses according to the progress of the trial as measured by actual hours expended by CRO personnel, investigator performance or completion of specific tasks, patient progression, or timing of various aspects of the trial.
Our objective is to reflect the appropriate development and trial expenses in our consolidated financial statements by matching those expenses with the period in which the services and efforts are expended by our service providers. 49 For clinical trials, we account for these expenses according to the progress of the trial as measured by actual hours expended by CRO personnel, investigator performance or completion of specific tasks, patient progression, or timing of various aspects of the trial.
The $3.9 million increase in CMC expense is primarily associated with a $1.8 million expense for drug product purchased in the year ended December 31, 2024 and a $1.9 million increase in expense associated with the manufacturing of drug product for SCY-247 and ibrexafungerp.
The $3.8 million decrease in CMC expense is primarily associated with a $3.8 million decrease in expense associated with the manufacturing of drug product for SCY-247 and ibrexafungerp. The decreases of $1.0 million in salary expense and $0.5 million in stock-based compensation expense are due to the decrease in the number of employees in the year ended December 31, 2025.
The net unfavorable change in operating assets and liabilities was due to a net decrease in operating liabilities of $0.9 million and by a net increase of $31.5 million in operating assets.
The net favorable change in operating assets and liabilities of $6.1 million is due to a net favorable change of $12.4 million due to the decrease in operating assets offset by a net unfavorable change of $6.3 million due to the decrease in operating liabilities.
In June 2021 and December 2022, we announced that the United States (U.S.) Food and Drug Administration (FDA) approved BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection, and for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC), respectively. Oral ibrexafungerp is also under development for other systemic fungal diseases.
Ibrexafungerp is the first representative of this novel class of antifungals and was approved by the U.S. Food and Drug Administration (FDA) as BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis (VVC) and for the reduction in the incidence of recurrent vulvovaginal candidiasis (rVVC) in 2021 and 2022, respectively.
For the year ended December 31, 2024, we recognized $0.2 million in income tax expense primarily for U.S. federal income tax. Liquidity and Capital Resources Sources of Liquidity As of December 31, 2024, we had cash, cash equivalents, and investments of approximately $75.1 million, compared to cash, cash equivalents, and investments of $98.0 million as of December 31, 2023.
Liquidity and Capital Resources Sources of Liquidity As of December 31, 2025, we had cash, cash equivalents, and investments of approximately $56.3 million, compared to cash, cash equivalents, and investments of $75.1 million as of December 31, 2024.
Net cash used in financing activities of $36.7 million for the year ended December 31, 2023, consisted primarily of the full repayment of the Loan Agreement with Hercules and SVBB in May 2023.
Financing Activities Net cash used in financing activities of $14.2 million for the year ended December 31, 2025, consisted primarily of the $14.0 million repayment of the convertible debt in March 2025.
The net increase of $31.5 million in operating assets is primarily due to a $19.3 million increase in license agreement contract asset associated with the GSK License Agreement, an increase in license agreement receivable of $2.5 million, and an increase of $4.4 million in unbilled receivable due from GSK associated with the Binding MOU.
The net $12.4 million decrease in operating assets is primarily due to a $9.5 million decrease in the license agreement contract asset due to the collection of the $10.0 million as part of the Binding 2025 MOU in the year ended December 31, 2025.
For the year ended December 31, 2024, revenue consists of the $3.7 million in license agreement revenue associated with the GSK License Agreement. For the year ended December 31, 2023, revenue primarily consists of the $130.1 million recognized upon the transfer of the license associated with the GSK License Agreement in May 2023. Cost of Product Revenues.
For the years ended December 31, 2025 and 2024, revenue consists of $20.6 million and $3.7 million primarily associated with the license agreement revenue recognized for the GSK License Agreement, respectively. For the year ended December 31, 2025, we recognized a cumulative catchup of license agreement revenue of $17.2 million associated with the Binding 2025 MOU.
The $0.9 million increase in operating liabilities was primarily due to an increase of $1.2 million in accounts payable and a decrease in accrued expenses, deferred revenue, other liabilities, and other of $0.3 million.
The net unfavorable change of $6.3 million in operating liabilities is primarily due to the $2.7 million decrease in deferred revenue given the satisfaction of the performance obligation associated with Phase 3 MARIO study in 2025 as part of the Binding 2025 MOU, a $2.2 million decrease in accounts payable, and a $1.0 million decrease in accrued expenses primarily due to the $0.6 million decrease in accrued product recall.
The decrease of $6.5 million, or 30.9%, was primarily driven by a decrease of $5.8 million in professional fees and a decrease of $0.9 million in commercial expense due to the costs incurred in the prior period associated with BREXAFEMME, offset by a net increase of $0.2 million in other selling, general, and administrative expense.
The decrease of $0.1 million, or 0.4%, was primarily driven by a decrease of $0.6 million in professional fees, offset in part by an increase of $0.5 million in business development expense. Amortization of Debt Issuance Costs and Discount.
For the years ended December 31, 2024 and 2023, we recognized $0.8 million and $3.1 million, respectively, in interest expense associated with our Loan Agreement and convertible debt. The decrease in interest expense was primarily due to the repayment of the Loan Agreement in May 2023. Other Income.
For the years ended December 31, 2025 and 2024, we recognized $0.2 million and $0.8 million, respectively, in interest expense on our March 2019 convertible notes which were fully paid at maturity in March 2025. Other Income.
For the year ended December 31, 2024, research and development expenses decreased to $26.4 million from $30.9 million for the year ended December 31, 2023.
For the year ended December 31, 2025, we recognized $1.4 million in product revenue, net for a change in estimate related to prior period revenue associated with the product recall of BREXAFEMME. Research and Development. For the year ended December 31, 2025, research and development expenses decreased to $22.3 million from $26.4 million for the year ended December 31, 2024.
Removed
Ibrexafungerp is the first representative of this novel class of antifungals with additional assets from the “fungerp” family under development, including SCY-247 which is currently in clinical stages of development.
Added
Ibrexafungerp was licensed to GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) in May 2023. A second generation fungerp SCY-247 is currently being evaluated in clinical trials and additional compounds from our proprietary fungerp platform, targeted to address significant unmet needs, are in earlier stages of development.
Removed
SCY-247, a second-generation antifungal compound from this novel class, is in clinical development and we initiated a Phase 1 study for SCY-247 in the fourth quarter of 2024.
Added
The FDA has granted Qualified Infectious Disease Product status and Fast Track designations for the oral formulation of SCY-247 which would provide regulatory exclusivity of at least 10 years, if approved.
Removed
The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to ibrexafungerp for the indications of VVC (including the prevention of recurrent VVC), invasive candidiasis (IC) (including candidemia), and invasive aspergillosis (IA), and has granted Orphan Drug designations for the IC and IA indications.
Added
SCY-247 Development Update We continue to progress the development activities for SCY-247 and recently completed the single and multiple ascending dose portions of our ongoing Phase 1 study of oral SCY-247 in 88 healthy subjects.
Removed
The European Medicines Agency has granted Orphan Medicinal Product designation to ibrexafungerp for IC. We anticipate that the FDA may grant QIDP and Fast Track designations for the IV and oral formulations of SCY-247. These designations may provide us with additional market exclusivity and expedited regulatory paths.
Added
The study evaluated the safety, tolerability and pharmacokinetics of orally administered SCY-247 in healthy participants receiving single ascending doses (SAD) ranging from 50mg to 900mg and multiple ascending doses (MAD) ranging from 50mg to 300mg, once a day for 7 days. Each dose level was evaluated in eight participants, with six participants receiving SCY-247 and two receiving a matching placebo.
Removed
GSK License Agreement On March 30, 2023, we entered into a license agreement (as amended in December 2023, the GSK License Agreement) with GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK).
Added
A total of 66 participants received SCY-247 and 22 received placebo in the SAD and MAD cohorts. SCY-247 was well tolerated across all evaluated SAD and MAD cohorts. No serious or severe treatment emergent adverse events (TEAEs) were reported. The incidence of TEAEs was low and not dose-dependent, with all events being mild or moderate in severity.
Removed
Pursuant to the terms of the GSK License Agreement, we granted GSK an exclusive (even as to us and our affiliates), royalty-bearing, sublicensable license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in all countries other than those in the Greater China region and certain other countries already licensed to third parties (the GSK Territory).
Added
One participant discontinued the study due to an adverse event that was deemed not to be related to the study drug. SCY-247 showed generally dose-proportional pharmacokinetics following single and multiple oral doses.
Removed
The parties closed the transactions contemplated by the GSK License Agreement in May 2023 and we received an upfront payment of $90.0 million. In June 2023 and July 2024, we announced the achievement of a $25.0 million and a $10.0 million performance-based development milestone under the GSK License Agreement, respectively.
Added
The drug was rapidly absorbed (Tmax ranging from three to seven hours), and systemic exposure (Cmax and AUC) increased proportionally for doses up to 400mg QD and less than proportional for doses higher than 400mg QD.
Removed
On December 26, 2023, we and GSK entered into a binding memorandum of understanding (Binding MOU) for amendment to the GSK License Agreement. The GSK License Agreement was amended in connection with the delay in the commercialization of BREXAFEMME (see "Product Recall and Clinical Hold" section) and further clinical development of ibrexafungerp associated with this event.
Added
The MAD cohorts of 200mg and 300mg once-daily achieved or exceeded the preliminary target for efficacious exposure, based on preclinical models of invasive candidiasis (IC) available to date, including models with strains such as Candida auris and echinocandin-resistant Candida glabrata that are resistant to current antifungal treatment options.
Removed
Under the terms of the updated GSK License Agreement, as amended by the Binding MOU, we are eligible to receive potential: • regulatory approval milestone payments of up to $49 million (revised from up to $70 million as provided in the GSK License Agreement); • commercial milestone payments of up to $57.5 million based on first commercial sale in IC (U.S./EU) (revised from up to $115 million as provided in the GSK License Agreement); and • and sales milestone payments of up to $179.5 / $169.75 / $145.5 million (depending on the date of GSK’s relaunch of BREXAFEMME in the U.S.) (revised from up to $242.5 million as provided in the GSK License Agreement). 47 These milestones are based on annual net sales in the GSK Territory, with a total of $64 / $54.25 / $46.5 million to be paid upon achievement of multiple sales thresholds up through $200 million; a total of $45.5 / $45.5 / $39 million to be paid upon achievement of multiple sales thresholds between $300 million and $500 million; and $35 / $35 / $30 million to be paid at each sales threshold of $750 million and $1 billion.
Added
Overall, the safety, tolerability, and pharmacokinetic profile observed in this study support the continued clinical development of SCY-247. Oral SCY-247 also achieved target exposures for invasive fungal disease at doses lower than first generation fungerps, which may confer distinct tolerability advantages.
Removed
We will continue to be responsible for the execution and costs of the ongoing clinical studies of ibrexafungerp, which at this stage is only the Phase 3 MARIO study, but will have the potential to receive up to $72.35 million in development milestones (revised from up to $75.5 million as provided in the GSK License Agreement), which comprise: $25 million already paid; $10 million already paid for the delivery to GSK of the final clinical study reports for the completed FURI, CARES, and NATURE clinical studies; up to $30 million for the achievement of two interim milestones associated with our resumption and continued performance of the MARIO study after the clinical hold is lifted; and $7.35 million for the successful completion of the Phase 3 MARIO study.
Added
We intend to progress the development of SCY-247 towards addressing significant unmet needs in the antifungal space that also represent attractive commercial opportunities. We have initiated a Phase 1 study with the intravenous formulation of SCY-247 in the first quarter of 2026. The clinical proof-of-concept Phase 2 study of SCY-247 is currently planned for 2026 in patients with IC.
Removed
In the case of each of the above milestones, such milestone events are defined in the GSK License Agreement, as amended by the Binding MOU. GSK will also pay royalties based on cumulative annual sales to us in the mid-single digit to mid-teen range. The royalty terms are not amended by the Binding MOU.
Added
Subsequent stages of development for SCY-247 are anticipated to include studies adequate to support an IC treatment indication, as well as evaluating SCY-247 for the prevention of invasive fungal diseases in patients at high risk.
Removed
Product Recall and Clinical Hold Following a review in 2023 by GSK of the manufacturing process and equipment at the vendor that manufactures the ibrexafungerp drug substance, we became aware that exetimibe, a non-antibacterial beta-lactam drug substance, was manufactured using equipment common to the manufacturing process for ibrexafungerp.
Added
MARIO Study Update 43 As previously disclosed, we and GSK entered into an exclusive license agreement dated March 30, 2023, which was subsequently amended by the binding memorandums of understanding dated December 26, 2023 and October 14, 2025 (collectively, the GSK License Agreement).
Removed
Current FDA draft guidance recommends segregating the manufacture of non-antibacterial beta-lactam compounds from other compounds since beta-lactam compounds have the potential to act as sensitizing agents that may trigger hypersensitivity or an allergic reaction in some people. In the absence of the recommended segregation, there is a risk of cross contamination.
Added
Pursuant to the GSK License Agreement, we were responsible for conducting the MARIO study which resumed in April 2025 after the FDA notified us that the clinical hold of ibrexafungerp had been lifted, triggering us to bill a $10.0 million development milestone to GSK in the three months ended June 30, 2025.
Removed
It is not known whether any ibrexafungerp has been contaminated with a beta-lactam compound and we have not received any reports of adverse events due to the possible beta-lactam cross contamination.
Added
Subsequently, GSK notified us of their intention to immediately terminate the MARIO study based on GSK's purported rights under the GSK License Agreement. We did not believe that GSK had the right to unilaterally terminate the MARIO study under the GSK License Agreement.
Removed
Nonetheless, out of an abundance of caution and in line with GSK’s recommendation, we recalled BREXAFEMME® (ibrexafungerp tablets) from the market and placed a temporary hold on clinical studies of ibrexafungerp, including the Phase 3 MARIO study.
Added
In October 2025, we entered into a binding memorandum of understanding (the Binding 2025 MOU) with GSK and we agreed to promptly wind-down and terminate the MARIO study and we received one-time, non-refundable payments totaling $24.8 million from GSK in November 2025. We will not receive any additional development milestone payments from GSK specifically associated with the MARIO study.
Removed
We are in the process of destroying all of the patient-level and clinical drug product returned to date with the assistance of an experienced vendor and we are substantially complete with the product recall. In September 2023, after we announced our voluntary clinical hold, the FDA concurred with our voluntary hold and placed a clinical hold.
Added
Except as described above with respect to the MARIO study, the Binding 2025 MOU does not alter the potential milestones and royalties payable to us under the GSK License Agreement, including with regard to sales of BREXAFEMME for VVC and rVVC. The Binding 2025 MOU was considered to represent a contract modification pursuant to ASC 606.
Removed
We are working with the FDA to discuss paths for resolution of this issue. The clinical hold and recall affected the Phase 3 MARIO study. Our clinical stage compound, SCY-247, was not affected by these developments.
Added
The Binding 2025 MOU does not include any additional distinct goods and services and the we therefore recognized a cumulative catchup of license agreement revenue of $17.2 million for the year ended December 31, 2025 for the updated progress of completing the performance obligation associated with the research and development activities for the Phase 3 MARIO Study.

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