SCYNEXIS INC
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 5, 2025
SCYX$3.50+6.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0000950170-25-107985
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001178253-25-000010
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 103 previous paragraphs and 110 current paragraphs.
46 unchanged; 41 reworded; 23 added; 14 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (23)
Current report
MARIO Study Update
Current report
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 will receive one-time payments totaling $24.8 million from GSK. We will not receive any additional development milestone payments from GSK specifically associated with the MARIO study. 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.
Current report
GSK has reiterated its commitment to continued collaboration with us regarding other aspects of the GSK License Agreement, including with respect to the commercialization of BREXAFEMME for VVC and rVVC indications. We are continuing to progress the transfer of the BREXAFEMME NDA (as defined in the Binding 2025 MOU) to GSK by the end of 2025. GSK anticipates being able to initiate regulatory interactions with the FDA in 2026 to discuss the relaunch of BREXAFEMME for VVC and rVVC in the U.S. market.
Current report
SCY-247 Target Product Profile
Current report
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. SCY-247 is being developed as oral and IV 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, Histoplasmaand Blastomyces genera. Additionally, SCY-247 has shownin vitro, andin vivo activity against multidrug-resistant organisms such as Candida aurisand synergistic/additive activity in combination with amphotericin B against fungi causing mucormycosis. SCY-247 has unique attributes that define its potential to address significant unmet medical needs and provide considerable commercial opportunities, including:
Current report
oral bioavailability, allowing for convenient long-term outpatient use;
Current report
activity against azole-resistant and most echinocandin-resistant Candida strains, including Candida auris and multidrug-resistant strains;
Current report
activity against azole-resistant Aspergillus strains;
Current report
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);
Current report
high tissue penetration, allowing high concentrations in the organs commonly affected by fungal infections;
Current report
half-life adequate for once a day oral dosing with a low risk of drug-drug interactions.
Current report
We believe that SCY-247, if approved, has the potential to address significant gaps with commercially available therapies in the following indications:
Current report
Invasive candidiasis (IC), including resistant infections. IC is a systemic infection by fungi of the Candidaspp genus that typically affects patients in the hospital that are either immunocompromised or undergoing invasive procedures. 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. Antifungal treatment duration typically ranges from 2 to 6 weeks. With an increase 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, antifungal with broad and potent anti-Candida activity covering all strains for cases where the susceptibility of the Candidaspp. causing the infection is unknown. SCY-247 has demonstrated potentin 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).
Current report
Prevention of invasive fungal infections (IFI) in patients at high risk. 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. The patients that typically receive these preventive antifungal approaches include those with leukemias 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. Duration of antifungal prophylaxis varies, depending on the underlying condition, but for a patient with leukemia and chemotherapy the duration is typically ~90 days, which explains the preference for oral options. Most guidelines recommend the use oral azoles for antifungal prophylaxis. However, novel medications introduced to more effectively treat the underlying malignancies can have their clearance from the body significantly impacted by the concurrent use of azole antifungals, that are well known to inhibit CYP enzymes (key metabolic path for clearance of many medications), increasing the potential for significant toxicities. In this vulnerable population, an antifungal prophylaxis approach that does not pose a significant risk for drug-drug interactions with the underlying disease treatments represents an unmet need. SCY-247 has demonstrated in vitro and/orin vivo activity against Candida, Aspergillus, Mucoralesand Pneumocystis spp, providing the needed antifungal coverage for this indication. Additionally the risk for drug-drug interactions via CYP inhibition appears to be very low, based on available data to date, making it a strong candidate to optimize antifungal prophylaxis for these patients.
Current report
In the future, we may also consider other indications for SCY-247 for which longer oral antifungal regimens are typically needed and would benefit from the broad-spectrum activity, favorable safety profile and low potential for drug-drug interactions, including for the treatment of chronic fungal infections.
Current report
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.
Current report
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. One participant discontinued the study due to an adverse event that was deemed not to be related to the study drug.
Current report
SCY-247 showed generally dose-proportional pharmacokinetics following single and multiple oral doses. The drug was rapidly absorbed (Tmax ranging from three to seven hours), and systemic exposure (Cmax and AUC) increased with dose. 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 available to date, including models with strains such as Candida auris and echinocandin-resistant Candida glabrata that are resistant to current antifungal treatment options. Overall, the safety, tolerability, and pharmacokinetic profile observed in this study support the continued clinical development of SCY-247.
Current report
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 anticipate initiating a Phase 1 study with the intravenous formulation in the first quarter of 2026. The clinical proof-of-concept Phase 2 study is planned in patients with invasive candidiasis and subsequent stages of development are anticipated to include studies adequate to support an invasive candidiasis treatment indication, as well as evaluating SCY-247 for the prevention of invasive fungal diseases in patients at high risk.
Current report
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 misstatements from March 31, 2023 to September 22, 2023 regarding manufacturing controls and related risks. The court granted our motion to dismiss with leave to amend on July 30, 2025, and on August 29, 2025, the parties stipulated to dismissal and the court dismissed the case with prejudice. On May 1, 2024 and on June 4, 2024, purported shareholder derivative complaints asserting related claims were filed in the same court and later consolidated. On October 15, 2025, the court dismissed the consolidated case without prejudice. For additional information regarding the details of the securities class action and the consolidated shareholder derivative action, see Item 1 in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 filed on August 13, 2025.
Current report
Income Tax Benefit. For the three months ended September 30, 2024, we recognized a $0.4 million income tax benefit for U.S. federal income tax.
Current report
Results of Operations for the Nine Months Ended September 30, 2025 and 2024
Current report
Net cash provided by financing activities of $16,000 for the nine months ended September 30, 2024, consisted primarily of the proceeds from employee stock purchase plan issuances.
Removed paragraphs (14)
Previous report
Oral ibrexafungerp is also under development for other systemic fungal diseases.
Previous report
MARIO Study and Clinical Hold Update
Previous report
As previously disclosed, the Phase 3 MARIO study of ibrexafungerp for the treatment of invasive candidiasis was placed on clinical hold in September 2023 following identification of a potential cross-contamination at the facility of the drug substance manufacturer in light of draft FDA guidance recommending that certain drugs be manufactured in separate facilities. One of these drugs, a non-antibiotic beta lactam drug called ezetimibe, was being manufactured at the same facility as ibrexafungerp. We have since moved the manufacture of the clinical supplies of ibrexafungerp to enable the continuation of the MARIO study to a new facility.
Previous report
Pursuant to the GSK License Agreement, we are responsible for conducting the MARIO study. The GSK License Agreement provides that certain material changes to the study, including termination, require mutual written agreement of both parties. We have not provided such agreement; in fact, GSK did not give any indication of an intent to terminate the MARIO study until the day it sent its notice. The GSK License Agreement only provides GSK with a unilateral termination right in the event that dosage of the first new patient in MARIO had not occurred by a particular date. The date was set as April 26, 2025, subject to automatic extension of up to two months if the implementation of additional in process control method validation was included in the amended IND or required by GSK, resulting in additional time in the manufacturing process. GSK has taken the position that the initial deadline was not extended. On the contrary, our position is that the triggering event for extension of the timeline for the maximum of two months clearly occurred since GSK required, and the amended IND includes, new in process control method validation that resulted in extension of the manufacturing process. Therefore, contrary to GSK’s notice, we believe that GSK does not have the unilateral right to terminate the MARIO study and we have thus informed GSK.
Previous report
We are seeking to resolve this disagreement with GSK. Meanwhile, we reinitiated the MARIO study and patient dosing resumed in the Phase 3 MARIO study in May 2025, triggering us to bill a $10.0 million development milestone to GSK in the three months ended June 30, 2025. We are seeking to collect our development milestones from GSK and ultimately complete the study. While at this time it is too early to say how this disagreement may be resolved, GSK has reiterated its commitment to continued collaboration regarding other aspects of the GSK License Agreement including with respect to the commercialization of BREXAFEMME for the VVC and RVVC indications.
Previous report
The September 2023 identification of a potential cross-contamination at the facility of the drug substance manufacturer also resulted in a recall of all commercial supplies of BREXAFEMME. The manufacturing of new commercial supplies of BREXAFEMME and eventual reintroduction to the market is carried out by GSK.
Previous report
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 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. 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. The court granted our motion to dismiss with leave to amend on July 30, 2025.
Previous report
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. These cases seek unspecified damages, disgorgement, unspecified equitable relief, interest, fees and costs. The complaints have been consolidated and are currently stayed. We disagree with the allegations and we intend to defend these litigations vigorously.
Previous report
Liquidity
Previous report
We have operated as a public entity since we completed our initial public offering in May 2014, which we refer to as our IPO. We also completed a follow-on public offering of our common stock in April 2015 and public offerings of our common stock and warrants in June 2016, March 2018, December 2019, December 2020, and April 2022. Our principal source of liquidity is cash, cash equivalents, and investments which totaled $46.5 million as of June 30, 2025.
Previous report
Collaborations and Licensing Agreements
Previous report
We are party to a number of licensing and collaboration agreements with partners in human health, including: (1) GSK, a pharmaceutical company, which we exclusively (even as to us and our affiliates) provide a, royalty-bearing, sublicensable license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in the GSK Territory; (2) Merck, a pharmaceutical company, under which we exclusively licensed the rights to ibrexafungerp in the field of human health, and agreed to pay Merck milestones upon the occurrence of specified events as well as tiered royalties based on worldwide sales of ibrexafungerp when and if it is approved (in 2014, Merck assigned to us the patents related to ibrexafungerp that it had exclusively licensed to us and, as contemplated by the agreement, we will continue to pay milestones and royalties); (3) Hansoh, a pharmaceutical company, which we have exclusively provided a license to research, develop and commercialize ibrexafungerp in the Greater China region, including mainland China, Hong Kong, Macau, and Taiwan; Hansoh recently received Chinese approval for ibrexafungerp in VVC and we will receive a milestone upon commercialization as well as royalties of approximately 10%; (4) R-Pharm, CJSC, or "R-Pharm," a leading supplier of hospital drugs in Russia, granting R-Pharm exclusive rights in the field of human health to develop and commercialize ibrexafungerp in Russia and several non-core markets, under which we are entitled to receive potential milestones and royalties and reimbursement for certain development costs incurred by us (this agreement is not material to our unaudited condensed consolidated balance sheets, statements of operations, or statements of cash flows); (5) Waterstone, an international pharmaceutical business, granting Waterstone exclusive worldwide rights to development and commercialization of SCY-635 for the treatment of viral diseases in humans, under which we are entitled to receive potential milestones and royalties; and (6) Cypralis Limited, or "Cypralis," a life sciences company, transferring to Cypralis certain cyclophilin inhibitor assets of ours, under which we are eligible to receive milestone payments upon the successful progression of certain Cypralis clinical candidates into later stage clinical studies and royalties payable upon product commercialization.
Previous report
Results of Operations for the Six Months Ended June 30, 2025 and 2024
Previous report
Net cash used in financing activities of $15,000 for the six months ended June 30, 2024, consisted primarily of deferred financing costs of $40,000.
Reworded paragraphs (41)
Previous wording
Operating results for the three and six months ended June 30, 2025, are not necessarily indicative of results that may occur in future interim periods or 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. These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to our management and involve significant elements of subjective judgment and analysis. Words such as “expects,” “will,” “anticipates,” “targets,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “potential,” “should,” “could,” variations of such words, and similar expressions are intended to identify forward-looking statements. Our actual results and the timing of events may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include those discussed under the heading “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2025, and in Part II, Item 1A of this Quarterly Report on Form 10-Q. 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 Quarterly Report on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report on Form 10-Q. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into or review of, all relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely on these statements.
Current wording
Operating results for the three and nine months ended September 30, 2025, are not necessarily indicative of results that may occur in future interim periods or 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. These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to our management and involve significant elements of subjective judgment and analysis. Words such as “expects,” “will,” “anticipates,” “targets,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “potential,” “should,” “could,” variations of such words, and similar expressions are intended to identify forward-looking statements. Our actual results and the timing of events may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include those discussed under the heading “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2025, and in Part II, Item 1A of this Quarterly Report on Form 10-Q. 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 Quarterly Report on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report on Form 10-Q. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into or review of, all relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely on these statements.
Previous wording
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 and for the reduction in the incidence of recurrent vulvovaginal candidiasis in 2021 and 2022, respectively. Oral ibrexafungerp is also under development for other systemic fungal diseases.
Current wording
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.
Previous wording
A second generation fungerp SCY-247 is currently being evaluated in clinical trials with additional compounds from our proprietary fungerp platform, targeted to address significant unmet needs, in earlier stages of development.
Current wording
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.
Previous wording
As previously disclosed, we and GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) entered into an exclusive license agreement dated March 30, 2023, which was subsequently amended by a binding memorandum of understanding dated December 26, 2023 (collectively, the GSK License Agreement).
Current wording
As previously disclosed, we and GlaxoSmithKline Intellectual Property (No. 3) Limited (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).
Previous wording
On April 24, 2025, the FDA notified us that the clinical hold on ibrexafungerp had been lifted and concluded that the Phase 3 MARIO study could resume. Subsequently, on April 28, 2025, GSK notified us of their intention to immediately terminate the study based on its purported rights under the GSK License Agreement to unilaterally terminate the MARIO study. GSK claimed that, as a result, it would have no obligations to pay any further development milestones related to the MARIO study, including $30.0 million tied to the resumption and continuation of the study. We do not believe that GSK currently has the right to unilaterally terminate the MARIO study under the GSK License Agreement.
Current wording
Pursuant to the GSK License Agreement, we are 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. 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.
Previous wording
We remain committed to developing novel antifungal solutions to the rising threat of deadly fungal infections including invasive candidiasis for which there are limited treatment options and significant concerns for emergence of resistances, as highlighted by the WHO in their call to industry and other parties for research, development and public health action in this area of unmet need.
Current wording
We remain committed to developing novel antifungal solutions to the rising threat of deadly fungal infections including invasive candidiasis for which there are limited treatment options and significant concerns for emergence of resistances, as highlighted by the World Health Organization in their call to industry and other parties for research, development and public health action in this area of unmet need.
Previous wording
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. The primary endpoint is safety and tolerability, and the secondary endpoint is pharmacokinetics. We expect to release the single ascending and multiple ascending dose data in the third quarter of 2025.
Current wording
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. 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. A total of 66 participants received SCY-247 and 22 received placebo in the SAD and MAD cohorts.
Previous wording
Revenue consists of license agreement revenue associated with GSK.
Current wording
Revenue consists of license agreement revenue associated with GSK License Agreement.
Previous wording
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.
Current wording
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 SCY-247, and to potentially develop our other product candidates, subject to the availability of additional funding.
Previous wording
All of our other expense (income) recognized in the three and six months ended June 30, 2025 and 2024, consists of amortization of debt issuance costs and discount, interest income, interest expense, the warrant liability fair value adjustment, and the derivative liability fair value adjustment.
Current wording
All of our other expense (income) recognized in the three and nine months ended September 30, 2025 and 2024, consists of amortization of debt issuance costs and discount, interest income, interest expense, the warrant liability fair value adjustment, and the derivative liability fair value adjustment.
Previous wording
For the six months ended June 30, 2024, our income tax expense recognized consists primarily of an expense for U.S. federal income tax.
Current wording
For the three and nine months ended September 30, 2024, our income tax expense recognized consists primarily of a benefit and an expense for U.S. federal income tax, respectively.
Previous wording
Revenue. For the three months ended June 30, 2025 and, 2024, revenue consists of $1.4 million and $0.7 million, respectively, in license agreement revenue associated with the GSK License Agreement.
Current wording
Revenue. For the three months ended September 30, 2025 and, 2024, revenue consists of $0.3 million and $0.7 million, respectively, in license agreement revenue associated with the GSK License Agreement.
Previous wording
Research and Development. For the three months ended June 30, 2025, research and development expenses increased to $7.1 million compared to $6.8 million for the three months ended June 30, 2024. The increase of $0.3 million, or 5%, for the three months ended June 30, 2025, was primarily driven by an increase of $0.3 million in chemistry, manufacturing, and controls (CMC) expense, an increase of $0.4 million in preclinical expense, and an increase of $0.2 million in clinical expense, offset in part by a decrease of $0.2 million in salary expense and a net decrease of $0.4 million in other research and development expense.
Current wording
Research and Development. For the three months ended September 30, 2025, research and development expenses decreased to $5.5 million compared to $8.1 million for the three months ended September 30, 2024. The decrease of $2.6 million, or 33%, for the three months ended September 30, 2025, was primarily driven by a decrease of $1.4 million in chemistry, manufacturing, and controls (CMC) expense, a decrease of $0.2 million in preclinical expense, a decrease of $0.2 million in clinical expense, a $0.2 million decrease in salary expense, a $0.3 million decrease in stock-based compensation expense, and a net decrease of $0.3 million in other research and development expense.
Previous wording
The $0.3 million increase in CMC expense is primarily associated with a $0.2 million increase in expense associated with the manufacturing of drug product for SCY-247 and ibrexafungerp. The $0.4 million increase in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247. The $0.2 million increase in clinical expense was primarily due to a $1.5 million increase in expense for the Phase 1 study for SCY-247, offset in part by a $0.7 million decrease in clinical expense for the FURI and CARES studies which were completed in the prior comparable period, a $0.1 million decrease in clinical expense associated with the Phase 3 MARIO study, a $0.1 million decrease in clinical expense for the VANQUISH study, and a net decrease of $0.4 million in other clinical expense.
Current wording
The $1.4 million decrease in CMC expense is primarily associated with a $1.5 million decrease in expense associated with the manufacturing of drug product for SCY-247 and ibrexafungerp. The $0.2 million decrease in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247 in the prior comparable period. The $0.2 million decrease in clinical expense was primarily due to a $0.5 million decrease in clinical expense for the FURI and CARES studies which were completed in the prior period, offset in part by a $0.3 million increase in clinical expense for the Phase 1 study for SCY-247. The decreases of $0.2 million in salary expense and $0.3 million in stock-based compensation expense are due to the decrease in the number of employees in the three months ended September 30, 2025.
Previous wording
Selling, General & Administrative. For the three months ended June 30, 2025, selling, general and administrative expenses increased to $3.8 million compared to $3.2 million for the three months ended June 30, 2024. The increase of $0.6 million, or 20%, for the three months ended June 30, 2025, was primarily driven by an increase of $0.4 million in professional fees.
Current wording
Selling, General & Administrative. For the three months ended September 30, 2025, selling, general and administrative expenses increased to $3.3 million compared to $2.9 million for the three months ended September 30, 2024. The increase of $0.4 million, or 13%, for the three months ended September 30, 2025, was primarily driven by an increase of $0.3 million in professional fees.
Previous wording
Interest Income. For the three months ended June 30, 2025 and 2024, we recognized $0.5 million and $1.1 million, respectively, in interest income on our money market funds and investments.
Current wording
Interest Income. For the three months ended September 30, 2025 and 2024, we recognized $0.5 million and $1.0 million, respectively, in interest income on our money market funds and investments.
Previous wording
Warrant Liabilities Fair Value Adjustment. For the three months ended June 30, 2025 and 2024, we recognized a gain of $2.2 million and a loss of $5.8 million, respectively, in the fair value adjustment related to the warrant liabilities primarily due to the decrease and increase in our stock price during the respective periods.
Current wording
Warrant Liabilities Fair Value Adjustment. For the three months ended September 30, 2025 and 2024, we recognized a loss of $0.6 million and a gain of $6.8 million, respectively, in the fair value adjustment related to the warrant liabilities primarily due to the increase and decrease in our stock price during the respective periods.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024, together with the changes in those items in dollars and percentage (dollars in thousands):
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024, together with the changes in those items in dollars and percentage (dollars in thousands):
Previous wording
Revenue. For the six months ended June 30, 2025 and, 2024, revenue consists of $1.6 million and $2.1 million, respectively, in license agreement revenue associated with the GSK License Agreement.
Current wording
Revenue. For the nine months ended September 30, 2025 and, 2024, revenue consists of $2.0 million and $2.8 million, respectively, in license agreement revenue associated with the GSK License Agreement.
Previous wording
Research and Development. For the six months ended June 30, 2025, research and development expenses decreased to $12.3 million compared to $14.0 million for the six months ended June 30, 2024. The decrease of $1.7 million, or 12%, for the six months ended June 30, 2025, was primarily driven by a decrease of $1.3 million in CMC expense, a decrease of $0.5 million in clinical expense, a decrease of $0.2 million in salary expense, and a net decrease in other research and development expense of $0.5 million, offset in part by an increase of $0.8 million in preclinical expense.
Current wording
Research and Development. For the nine months ended September 30, 2025, research and development expenses decreased to $17.7 million compared to $22.1 million for the nine months ended September 30, 2024. The decrease of $4.4 million, or 20%, for the nine months ended September 30, 2025, was primarily driven by a decrease of $2.7 million in CMC expense, a decrease of $0.7 million in clinical expense, a decrease of $0.4 million in salary expense, a $0.3 million decrease in stock-based compensation and a net decrease in other research and development expense of $0.9 million, offset in part by an increase of $0.6 million in preclinical expense.
Previous wording
The $1.3 million decrease in CMC expense is primarily associated with a $1.6 million decrease in expense associated with the manufacturing of drug product for SCY-247 and ibrexafungerp. The $0.5 million decrease in clinical expense was primarily due to a $1.3 million decrease in clinical expense for the FURI and CARES studies which were completed in the prior comparable period, a $0.2 million decrease in clinical expense associated with the Phase 3 MARIO study, a $0.3 million decrease in clinical expense associated with the VANQUISH study, and a net decrease of $1.0 million in other clinical expense, offset in part by a $2.3 million increase in clinical expense for the Phase 1 study for SCY-247. The $0.8 million increase in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247.
Current wording
The $2.7 million decrease in CMC expense is primarily associated with a $3.1 million decrease in expense associated with the manufacturing of drug product for SCY-247 and ibrexafungerp. The $0.7 million decrease in clinical expense was primarily due to a $1.9 million decrease in clinical expense for the FURI and CARES studies which were completed in the prior period, a $0.3 million decrease in clinical expense associated with the VANQUISH study, and a net decrease of $1.0 million in other clinical expense, offset in part by a $2.5 million increase in clinical expense for the Phase 1 study for SCY-247. The decreases of $0.4 million in salary expense and $0.3 million in stock-based compensation expense are due to the decrease in the number of employees in the nine months ended September 30, 2025. The $0.6 million increase in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247 in the current period.
Previous wording
Selling, General & Administrative. For the six months ended June 30, 2025, selling, general and administrative expense increased to $7.5 million compared to $6.8 million for the six months ended June 30, 2024. The increase of $0.7 million, or 10%, for the six months ended June 30, 2025, was primarily driven by an increase of $0.3 million in business development expense, an increase of $0.3 million in salary expense, and a net increase of $0.1 million in other selling, general, and administrative expense.
Current wording
Selling, General & Administrative. For the nine months ended September 30, 2025, selling, general and administrative expense increased to $10.8 million compared to $9.7 million for the nine months ended September 30, 2024. The increase of $1.1 million, or 11%, for the nine months ended September 30, 2025, was primarily driven by an increase of $0.5 million in business development expense, an increase of $0.3 million in salary expense, and a net increase of $0.3 million in other selling, general, and administrative expense.
Previous wording
Amortization of Debt Issuance Costs and Discount. For the six months ended June 30, 2025 and 2024, we recognized $0.3 million and $0.8 million in amortization of debt issuance costs and discount, respectively. 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.
Current wording
Amortization of Debt Issuance Costs and Discount. For the nine months ended September 30, 2025 and 2024, we recognized $0.3 million and $1.3 million in amortization of debt issuance costs and discount, respectively. 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.
Previous wording
Interest Income. For the six months ended June 30, 2025 and 2024, we recognized $1.3 million and $2.4 million, respectively, in interest income on our money market funds and investments.
Current wording
Interest Income. For the nine months ended September 30, 2025 and 2024, we recognized $1.8 million and $3.4 million, respectively, in interest income on our money market funds and investments.
Previous wording
Interest Expense. For the six months ended June 30, 2025 and 2024, we recognized $0.2 million and $0.4 million in interest expense on our March 2019 convertible notes which were fully paid at maturity in March 2025.
Current wording
Interest Expense. For the nine months ended September 30, 2025 and 2024, we recognized $0.2 million and $0.6 million in interest expense on our March 2019 convertible notes which were fully paid at maturity in March 2025.
Previous wording
Warrant Liabilities Fair Value Adjustment. For the six months ended June 30, 2025 and 2024, we recognized gains of $5.1 million and $3.8 million, respectively, in the fair value adjustment related to the warrant liabilities primarily due to the decrease in our stock price during the periods.
Current wording
Warrant Liabilities Fair Value Adjustment. For the nine months ended September 30, 2025 and 2024, we recognized gains of $4.5 million and $10.6 million, respectively, in the fair value adjustment related to the warrant liabilities primarily due to the decrease in our stock price during the periods.
Previous wording
Derivative Liability Fair Value Adjustment. For the six months ended June 30, 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.
Current wording
Derivative Liability Fair Value Adjustment. For the nine months ended September 30, 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.
Previous wording
Income Tax Expense. For the six months ended June 30, 2024, our income tax expense recognized consists primarily of an expense for U.S. federal income tax.
Current wording
Income Tax Expense. For the nine months ended September 30, 2024, our income tax expense recognized consists primarily of an expense for U.S. federal income tax.
Previous wording
As of June 30, 2025, we had cash and cash equivalents and investments of $46.5 million, compared to cash and cash equivalents and short-term investments of $75.1 million as of December 31, 2024. 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 unaudited condensed consolidated financial statements. As of June 30, 2025, our accumulated deficit was $388.8 million.
Current wording
As of September 30, 2025, we had cash and cash equivalents and investments of $37.9 million, compared to cash and cash equivalents and short-term investments of $75.1 million as of December 31, 2024. 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 unaudited condensed consolidated financial statements. As of September 30, 2025, our accumulated deficit was $397.4 million.
Previous wording
As of June 30, 2025, our accumulated deficit was $388.8 million. We expect we will continue to incur significant research and development expense as we continue to execute our research and drug development strategy. Consistent with our operating plan, we also expect that we will continue to incur significant selling, general and administrative expenses to support our public reporting company operations and ongoing operations. As a result, we will need additional capital to fund our operations, which we may obtain through one or more of equity offerings, debt financings, other non-dilutive third-party funding (e.g., grants), strategic alliances and licensing or collaboration arrangements. We may offer shares of our common stock pursuant to our effective shelf registration statements or our “at-the-market” offering program pursuant to the Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co.
Current wording
Consistent with our operating plan, we expect to incur significant research and development expenses and selling, general and administrative expenses. As a result of our continued significant expenses, we will need additional capital to fund our operations, which we may obtain through one or more of equity offerings, debt financings, other non-dilutive third-party funding (e.g., grants), strategic alliances and licensing or collaboration arrangements. We may offer shares of our common stock pursuant to our effective shelf registration statements or our “at-the-market” offering program pursuant to the Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co.
Previous wording
The following table sets forth the significant sources and uses of cash for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table sets forth the significant sources and uses of cash for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
The $0.1 million increase in net cash used in operating activities for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024 was primarily due to the continued development costs associated with SCY-247 and ibrexafungerp in the six months ended June 30, 2025.
Current wording
The $9.6 million increase in net cash used in operating activities for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024 was primarily due to the continued development costs associated with SCY-247 and ibrexafungerp in the nine months ended September 30, 2025.
Previous wording
Net cash used in operating activities of $15.0 million for the six months ended June 30, 2025, primarily consisted of the $12.3 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant liability of $5.1 million and stock-based compensation expense of $1.6 million, partially offset by a net favorable change in operating assets and liabilities of $0.6 million. The net favorable change in operating assets and liabilities of $0.6 million is due to a net favorable change of $1.1 million due to the decrease in operating assets offset by a net unfavorable change of $0.4 million due to the decrease in operating liabilities The net $1.1 million decrease in operating assets is primarily due to a $0.8 million decrease in prepaid expenses, other assets, deferred costs, and other. The $0.8 million decrease in prepaid expenses, other assets, deferred costs, and other was primarily due to the $0.4 million decrease in prepaid research and development services that were recognized in the six months ended June 30, 2025 and a $0.4 million decrease in other current assets. The net unfavorable change of $0.4 million in operating liabilities is primarily due to the $1.7 million increase in accounts payable, offset in part by a $1.3 million decrease in accrued expenses primarily due to the $0.9 million decrease in accrued bonus which was paid in the six months ended June 30, 2025.
Current wording
Net cash used in operating activities of $23.7 million for the nine months ended September 30, 2025, primarily consisted of the $20.9 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant liability of $4.5 million and stock-based compensation expense of $2.2 million, partially offset by a net unfavorable change in operating assets and liabilities of $0.7 million. The net unfavorable change in operating assets and liabilities of $0.7 million is due to a net favorable change of $2.0 million due to the decrease in operating assets offset by a net unfavorable change of $2.7 million due to the decrease in operating liabilities. The net $2.0 million decrease in operating assets is primarily due to a $1.7 million decrease in prepaid expenses, other assets, deferred costs, and other. The $1.7 million decrease in prepaid expenses, other assets, deferred costs, and other was primarily due to the $1.2 million decrease in other current assets for certain collected unbilled receivables in the nine months ended September 30, 2025. The net unfavorable change of $2.7 million in operating liabilities is primarily due to the $1.0 million decrease in accounts payable and a $1.0 million decrease in accrued expenses primarily due to the $0.6 million decrease in accrued bonus which was paid in the nine months ended September 30, 2025.
Previous wording
Net cash used in operating activities of $14.9 million for the six months ended June 30, 2024, primarily consisted of the $14.0 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant liabilities of $3.8 million, stock-based compensation expense of $1.5 million, and amortization of debt issuance costs and discount of $0.8 million, partially offset by a net favorable change in operating assets and liabilities of $1.4 million. The net favorable change in operating assets and liabilities was due to a net decrease in operating liabilities of $4.8 million and by a net decrease of $6.2 million in operating assets. The net $6.2 million decrease in operating assets is primarily due to a $2.2 million decrease in the license agreement receivable associated with the GSK License Agreement which was collected in the six months ended June 30, 2024 and a $4.1 million decrease in prepaid expenses, other assets, deferred costs, and other. The $4.1 million decrease in prepaid expenses, other assets, deferred costs, and other was primarily due to the collection of a $4.4 million unbilled receivable in the six months ended June 30, 2024 from GSK.
Current wording
Net cash used in operating activities of $14.1 million for the nine months ended September 30, 2024, primarily consisted of the $16.9 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant liabilities of $10.6 million, stock-based compensation expense of $2.4 million, and amortization of debt issuance costs and discount of $1.3 million, partially offset by a net favorable change in operating assets and liabilities of $10.8 million. The net favorable change in operating assets and liabilities of $10.8 million is due to a favorable change of $16.2 million due to the decrease in operating assets, offset by an unfavorable change of $5.4 million due to the decrease in operating liabilities The net $16.2 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 nine months ended September 30, 2024, a $2.3 million decrease in the license agreement receivable associated with the GSK License Agreement which was collected in the nine months ended September 30, 2024, and a $4.0 million decrease in prepaid expenses, other assets, deferred costs, and other. The $4.0 million decrease in prepaid expenses, other assets, deferred costs, and other was primarily due to the collection of a $4.4 million unbilled receivable in the nine months ended September 30, 2024 from GSK. The net unfavorable change of $5.4 million in operating liabilities is primarily due to the $2.2 million decrease in accounts payable and a $2.0 million decrease in accrued expenses primarily resulting from the $1.0 million decrease in accrued research and development expenses.
Previous wording
Net cash provided by investing activities for the six months ended June 30, 2025 consisted of the maturities of investments of $23.7 million.
Current wording
Net cash provided by investing activities for the nine months ended September 30, 2025 consisted of the maturities of investments of $36.1 million.
Previous wording
Net cash provided by investing activities of $6.8 million for the six months ended June 30, 2024 consisted of purchases and maturities of investments of $10.7 million and $17.5 million, respectively.
Current wording
Net cash provided by investing activities of $8.8 million for the nine months ended September 30, 2024 consisted of purchases and maturities of investments of $28.0 million and $36.8 million, respectively.
Previous wording
Net cash used in financing activities of $14.1 million for the six months ended June 30, 2025, consisted primarily of the $14.0 million repayment of the convertible debt in March 2025.
Current wording
Net cash used in financing activities of $14.1 million for the nine months ended September 30, 2025, consisted primarily of the $14.0 million repayment of the convertible debt in March 2025.
Previous wording
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. Because of the numerous risks and uncertainties associated with the development and commercialization of product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses necessary to complete the development of product candidates.
Current wording
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. Because of the numerous risks and uncertainties associated with the development and commercialization of product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses necessary to complete the development of product candidates.
Previous wording
our ability to successfully achieve the development, regulatory, and commercial milestones under our GSK License Agreement;
Current wording
our ability to successfully achieve the regulatory and commercial milestones under our GSK License Agreement;
Previous wording
the progress, and costs, of the clinical development of SCY-247 and ibrexafungerp;
Current wording
the progress, and costs, of the clinical development of SCY-247;
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Previous report — wording carried elsewhere
Derivative Liability Fair Value Adjustment. For the three months ended June 30, 2024, we recognized a gain of $28,000 in the fair value adjustment related to the derivative liability primarily due to the decrease in our stock price during the period.
Previous report — wording carried elsewhere
Consistent with our operating plan, we expect to incur significant research and development expenses and selling, general and administrative expenses. As a result of our continued significant expenses, we may need additional capital to fund our operations, which we may obtain through one or more of equity offerings, debt financings, or other non-dilutive third-party funding, strategic alliances and licensing or collaboration arrangements.