What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-04 compared with 2025-03-12 · 307 added, 524 removed, 730 unchanged (53% of the section changed)

9 unchanged sentences

SCYNEXIS, Inc.

is pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections.

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.

We are developing our proprietary antifungal platform “fungerps”, a novel class of antifungal agents called triterpenoids, that are structurally distinct glucan synthase inhibitors and have generally shown in vitro and in vivo activity against a broad range of human fungal pathogens such as Candida and Aspergillus genera, including multidrug-resistant strains, as well as Pneumocystis , Coccidioides , Histoplasma and Blastomyces genera and most common mucorales species.

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.

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.

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.

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.

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.

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).

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).

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.

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.

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 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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

We continue to progress the development activities for SCY-247.

SCY-247 is a broad-spectrum antifungal with a potential oral and IV systemic therapeutic option for multiple drug-resistant pathogens.

Some of these activities, including assessing the activity of the compound against multi-drug resistant pathogens such as Candida auris and Mucorales, are being supported by NIH grants.

We initiated a Phase 1 study for SCY-247 in the fourth quarter of 2024.

The Phase 1 study is a randomized, double-blind, placebo-controlled study of single and multiple ascending doses of oral SCY-247 in approximately 100 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.

Loan Agreement

We, Hercules Capital, Inc.

(Hercules Capital) and Silicon Valley Bridge Bank, N.A.

(as successor to Silicon Valley Bank) (SVBB) were parties to a Loan and Security Agreement dated as of May 13, 2021 (the Loan Agreement), pursuant to which Hercules Capital, SVBB and each of the other lenders from time-to-time party to the Loan Agreement (collectively, the Lenders) loaned to us $35 million.

In connection with the entering into of the GSK License Agreement, we entered into a First Amendment and Consent to Loan and Security Agreement with the Lenders pursuant to which the Lenders consented to us entering into the GSK License Agreement and we agreed to pay to the Lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement (approximately $35.4 million), (ii) the prepayment fee payable under Loan Agreement ($262,500), (iii) the final payment payable under Loan Agreement ($1,382,500), and (iv) all other sums, if any, that shall have become due and payable with respect to loan advances under the Loan Agreement.

These payments became due upon the earliest of (A) one business day

following receipt by us of the $90 million upfront payment payable to us under the GSK License Agreement, (B) June 1, 2023, or (C) the termination of the GSK License Agreement.

Following the closing of the transactions under the GSK License Agreement, in May 2023, we received the upfront payment pursuant to the terms of the GSK License Agreement, which triggered the obligation of us to repay the amounts due under the terms of the First Amendment.

In connection with the repayment of those amounts due, in May 2023, we and the Lenders executed a payoff letter confirming the amounts due under the First Amendment, and our confirmation that the Loan Agreement, as amended by the First Amendment, was terminated.

Class Action Lawsuit

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.

We have filed a motion to dismiss.

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 were consolidated and are currently stayed.

We disagree with the allegations and we intend to defend these litigations vigorously.

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 $75.1 million as of December 31, 2024.

As of December 31, 2024, our accumulated deficit was $376.5 million.

We expect we will continue to incur significant research and development expense as we continue to execute our research and drug development strategy.

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 Sales Agreement.

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 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.

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.

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.

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.

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.

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 proportionally for doses up to 400mg QD and less than proportional for doses higher than 400mg QD.

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.

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.

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.

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.

MARIO Study Update

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).

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.

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.

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.

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.

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.

The cumulative catchup includes $2.2 million previously recorded as deferred revenue.

The one-time, non-refundable payments totaling $24.8 million collected from GSK as part of the Binding 2025 MOU include $10.0 million to satisfy the license agreement receivable previously recognized as of June 30, 2025.

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 completed the transfer of the BREXAFEMME NDA (as defined in the Binding 2025 MOU) to GSK in November 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.

We remain committed to developing novel antifungal solutions to the rising threat of deadly fungal infections including IC 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.

Nasdaq Minimum Bid Price Notification

On June 20, 2025, we received a letter from the Listing Qualifications Department staff (the Staff) of the Nasdaq notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the $1.00 per share minimum required for continued listing on the Nasdaq Global Market as set forth in Nasdaq Listing Rule 5450(a)(1).

The letter from Nasdaq had no immediate effect on the listing of our common stock on the Nasdaq Global Market.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had 180 calendar days from June 20, 2025, or until December 17, 2025 (the Compliance Date), to regain compliance with the minimum bid price rule.

In December 2025, we announced that we had received an additional 180-calendar-day extension from the Nasdaq to regain compliance with the minimum bid price requirement, as outlined in Nasdaq Listing Rule 5550(a)(2).

We now have until June 15, 2026, to meet the requirement for our shares of common stock to maintain a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days.

Nasdaq granted the extension after determining that we continue to meet all other continued listing criteria for the Nasdaq Capital Market, including the market value of publicly held shares, and we have provided written notice of our intention to cure the deficiency within the extension period, if necessary, through a reverse stock split.

Components of Operating Results

Revenue consists of license agreement revenue associated with GSK and product sales of BREXAFEMME.

Our product revenue, net comprised of sales of BREXAFEMME that we sold as principal given we control BREXAFEMME product until delivery to our wholesalers at which point control is transferred.

Cost of Product Revenue

Cost of product revenue consists primarily of inventory impairment expense, distribution, freight expenses, royalties due to Merck, and other manufacturing costs associated with BREXAFEMME.

Revenue consists of license agreement revenue associated with the GSK License Agreement and product revenue, net.

Research and Development Expense

9 unchanged sentences

• allocated overhead.

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.

The successful development of product candidates is highly uncertain.

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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.

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.

7 unchanged sentences

Operating expenses:

Cost of product revenue

Research and development

1 unchanged sentence

Total operating expenses

(Loss) income from operations

Loss from operations

Other expense (income):

2 unchanged sentences

Interest expense

Warrant liabilities fair value adjustment

Derivative liabilities fair value adjustment

Total other (income) expense

(Loss) income before taxes

Warrant liability fair value adjustment

Derivative liability fair value adjustment

Total other income

Loss before taxes

Income tax expense

Net (loss) income

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 year ended December 31, 2023, cost of product revenue consists primarily of the $14.5 million in impairment expense recognized in the period in addition to manufacturing, distribution, freight, and royalty costs associated with BREXAFEMME.

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.

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.

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 $7.4 million decrease in clinical expense was primarily due to a $4.4 million decrease in expense for the Phase 3 MARIO study as a result of the clinical hold on ibrexafungerp, a $1.6 million decrease in the expense associated with the FURI, CARES, and SCYNERGIA studies which were substantially complete by the second quarter of 2024, a $1.0 million decrease in expense associated with a Phase 1 study of oral ibrexafungerp that was substantially completed in the prior period and is intended to support the potential NDA filing for the treatment of IC, and a $1.0 million decrease in expense associated with the Phase 1 lactation study, offset in part by a $0.8 increase in expense recognized in the year ended December 31, 2024 for the Phase 1 study for SCY-247 which was initiated in the fourth quarter of 2024.

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 $0.7 million increase in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247.

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.

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 $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.

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 $5.8 million decrease in professional fees was primarily due to a $3.1 million expense incurred during the prior period for business development associated with the GSK License Agreement, a $0.8 million nonrecurring legal expense incurred in the prior period, a $0.7 million decrease in legal costs associated with the GSK License Agreement, and a $0.5 million expense recognized in the prior period to write off a deferred asset for certain commitment fees associated with the Loan Agreement.

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, 2025 and 2024, we recognized $0.3 million and $1.7 million in amortization of debt issuance costs and discount, respectively.

The decrease of $1.3 million, or 42%, was primarily driven by the recognition, in the prior period, of $1.9 million in amortization for the remaining debt issuance costs and discount associated with the Loan Agreement which was fully paid in May 2023.

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.

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.

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.

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, 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.

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.

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Warrant Liabilities Fair Value Adjustment .

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.

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.

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.

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.

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Cash, cash equivalents, and restricted cash, January 1

Net cash (used in) provided by operating activities

Net cash provided by (used in) investing activities

Net cash used in operating activities

Net cash provided by investing activities

Net cash used in financing activities

Net decrease in cash, cash equivalents, and restricted cash

Net increase (decrease) in cash, cash equivalents, and restricted cash

Cash, cash equivalents, and restricted cash, December 31

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.

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.

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.

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.

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.

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.

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.

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 $3.4 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 year ended December 31, 2024 from GSK.

The net unfavorable change of $7.7 million in operating liabilities is primarily due to the $2.7 million decrease in accounts payable and a $3.7 million decrease in accrued expenses primarily due to the $2.1 million decrease in accrued research and development expenses and a $1.4 million decrease in accrued product recall.

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.

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 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 $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 $0.3 million decrease in accrued expenses, deferred revenue, other liabilities, and other of $0.3 million was primarily due to the increase of deferred revenue of $3.9 million associated with GSK License Agreement and an increase of $1.8 million in accrued expenses primarily due to the $1.9 million increase for product recall, offset in part by a decrease of other liabilities of $5.8 million due to the Amplity deferred fees paid in February 2023.

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 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.

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.

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.

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 $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.

Future Cash Needs and Funding Requirements

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We anticipate that we will need substantial additional funding in connection with our continuing future operations.

We are continually evaluating our operating plan and assessing the optimal cash utilization for our SCY-247 and ibrexafungerp development strategy.

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.

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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;

• the progress, costs, and the clinical and preclinical research and development of ibrexafungerp and SCY-247;

• 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;

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• our need to expand our research and development activities;

• the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities;

• 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;

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Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

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

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.

Critical Accounting Judgments and Estimates

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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

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Analyzing the arrangement to identify performance obligations requires the use of judgment.

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.

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.

Factors that are considered in evaluating whether a license is distinct from other promised services include, for example, whether the counterparty can benefit from the license without the promised service on its own or with other readily available resources and whether the promised service is expected to significantly modify or customize the intellectual property.

We assessed the terms of the GSK License Agreement and identified the following performance obligations which include:

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.

For the GSK License Agreement, we allocate the transaction price based on relative standalone selling prices of each of the performance obligations.

We developed the estimated standalone selling price for the license using a Monte Carlo valuation analysis and for the research and development activities, we utilized the estimate of costs to be incurred to fulfill its obligations associated with the performance of the research and development activities, plus a reasonable margin.

In developing this estimate for the license, we applied significant judgment in the determination of the significant assumptions relating to forecasted future cash flows and discount rates.

Product Recall

We establish reserves for product recalls on a product-specific basis when circumstances giving rise to the recall become known.

We estimate product recall from consumers and customers across distribution channels, utilizing third-party data and other assumptions, and these are recorded within gross-to-net expenses on our consolidated statement of operations.

Additionally, we estimate costs for any additional fees, including but not limited to freight and destruction charges for returned products and costs incurred by third party vendors.

These expenses are recorded within selling, general, and administrative expenses within our consolidated statement of operations as they are in excess of the initial revenue recognized.

These estimates are updated and reevaluated each period and the related reserves are adjusted when these factors indicate that the recall reserves are either insufficient to cover or exceed the estimated product recall expenses.

Significant changes in the assumptions used to develop estimates for product recall reserves could affect key financial information, including inventory, accrued liabilities, net sales, gross profit, and net income (loss).

For the Binding 2025 MOU, we reviewed for additional distinct goods and services included in the contract modification which requires significant judgment.

Our review of the Binding 2025 MOU for additional distinct goods and services included a thorough analysis of the terms of the contract modification and we did not identify any distinct goods or services being added under the Binding 2025 MOU.

As a result, we 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.

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.

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.

The financial terms of these contracts are subject to negotiations which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts.

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Selling, general and administrative

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.

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.

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.

Warrant Liability

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.

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Notes to the Consolidated Financial Statements

REPORT OF INDEPENDENT R EGISTERED PUBLIC ACCOUNTING FIRM

REPORT OF INDEPENDENT RE GISTERED PUBLIC ACCOUNTING FIRM

To the shareholders and the Board of Directors of SCYNEXIS, Inc.

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We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

Critical audit matters are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.

We determined that there are no critical audit matters.

Critical Audit Matter

The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

License Agreement Revenue- GSK License Agreement — Refer to Notes 1, 2, and 8 to the financial statements

Critical Audit Matter Description

As described in Note 8 to the financial statements, the Company executed in 2025 a binding memorandum of understanding (the "Binding 2025 MOU") with GSK to wind down and terminate the MARIO study.

The Company determined that the Binding 2025 MOU represents a contract modification within the scope of ASC 606, Revenue from contracts with customers, further concluding it does not include any additional distinct goods and services.

The Company received one-time, non-refundable payments totaling $24.8 million collected from GSK, of which $17.2 million was recognized as a cumulative catchup of license agreement revenue for the year ended December 31, 2025.

Auditing the Company’s accounting for the Binding 2025 MOU required increased audit effort due to the complex and judgmental nature of evaluating the terms and the appropriate accounting for the modification under the guidance.

How the Critical Audit Matter Was Addressed in the Audit

Our audit procedures related to the accounting for license revenue recorded for the Binding 2025 MOU included the following, among others;

inspection of the executed Binding 2025 MOU and evaluating whether management’s accounting position considered all relevant facts and terms included in the agreement.

We further evaluated management’s technical analysis and assessed management’s conclusions to determine whether they had appropriately considered and applied the guidance and associated interpretations.

/s/ Deloitte & Touche LLP

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Cash and cash equivalents

Short-term investments (See Note 3)

Prepaid expenses and other current assets (See Note 4)

Short-term investments (Note 3)

Prepaid expenses and other current assets (Note 4)

License agreement receivable

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Total current assets

Investments (See Note 3)

Investments (Note 3)

Deferred offering costs

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Accounts payable

Accrued expenses (See Note 5)

Accrued expenses (Note 5)

Deferred revenue, current portion

Operating lease liability, current portion (Note 6)

Warrant liabilities

Convertible debt and derivative liability (Note 6)

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Deferred revenue

Warrant liabilities

Convertible debt and derivative liability (Note 6)

Warrant liability

Operating lease liability (Note 6)

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Stockholders’ equity:

Preferred stock, $ 0.001 par value, authorized 5,000,000 shares as of December 31, 2024 and December 31, 2023;

0 shares issued and outstanding as of December 31, 2024 and December 31, 2023

Preferred stock, $ 0.001 par value, authorized 5,000,000 shares as of December 31, 2025 and 2024;

0 shares issued and outstanding as of December 31, 2025 and 2024

Common stock, $ 0.001 par value, 150,000,000 shares authorized as of December 31, 2025 and 2024;

37,973,991 and 37,207,799 shares issued and outstanding as of December 31, 2024, and December 31, 2023, respectively

43,541,510 and 37,973,991 shares issued and outstanding as of December 31, 2025 and 2024, respectively

Additional paid-in capital

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Operating expenses:

Cost of product revenue

Research and development

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Total operating expenses

(Loss) income from operations

Loss from operations

Other expense (income):

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Interest expense

Warrant liabilities fair value adjustment

Warrant liability fair value adjustment

Derivative liability fair value adjustment

Total other (income) expense

(Loss) income before taxes

Total other income

Loss before taxes

Income tax expense

Net (loss) income

Net (loss) income per share attributable to common stockholders – basic

Net (loss) income per share – basic

Net (loss) income per share attributable to common stockholders – diluted

Net (loss) income per share – diluted

Net loss per share – basic and diluted

Weighted average common shares outstanding – basic and diluted

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Common stock issued through employee stock purchase plan

Common stock issued, net of expenses

Common stock issued for vested restricted stock units

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Common stock issued for vested restricted stock units

Common stock issued, net of expenses

Balances as of December 31, 2025

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Cash flows from operating activities:

Net (loss) income

Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:

Depreciation and amortization

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation expense

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Noncash operating lease expense for right-of-use asset

Inventory impairment expense

Write off of deferred asset for commitment fees

Prepayment fee for loan payable payment

Changes in operating assets and liabilities:

Prepaid expenses, other assets, deferred costs, and other

Prepaid expenses and other current assets, deferred costs, and other

License agreement contract asset

License agreement receivable

Accounts receivable

Accounts payable

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Other liabilities and other

Net cash (used in) provided by operating activities

Net cash used in operating activities

Cash flows from investing activities:

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Maturity of investments

Net cash provided by (used in) investing activities

Net cash provided by investing activities

Cash flows from financing activities:

Payments of offering costs

Payments of loan payable

Payment of loan payable prepayment fee

Proceeds from common stock issued

Payment of convertible debt

Payments of deferred offering costs

Proceeds from employee stock purchase plan issuances

Repurchase of shares to satisfy tax withholdings

Net cash used in financing activities

Net decrease in cash, cash equivalents, and restricted cash

Net increase (decrease) in cash, cash equivalents, and restricted cash

Cash, cash equivalents, and restricted cash at beginning of period

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Deferred offering and issuance costs included in accounts payable

Deferred offering costs reclassified to additional paid-in capital

The accompanying notes are an integral part of the financial statements.

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("SCYNEXIS" or the “Company”) is a Delaware corporation formed on November 4, 1999.

SCYNEXIS is a biotechnology company, headquartered in Jersey City, New Jersey, and is pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections.

The Company is developing its proprietary class of enfumafungin-derived antifungal compounds (“fungerps") as broad-spectrum, systemic antifungal agents for multiple fungal indications.

In June 2021, the 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 in December 2022, the Company announced that the FDA approved a second indication for BREXAFEMME for the reduction in the incidence of recurrent vulvovaginal candidiasis ("RVVC").

In March 2023, the Company entered into a license agreement (as amended in December 2023, the "GSK License Agreement") with GlaxoSmithKline Intellectual Property (No.

3) Limited ("GSK") in which the Company granted GSK an exclusive (even as to the Company and its affiliates), royalty-bearing, sublicensable license for the development and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in all countries other than Greater China and certain other countries already licensed to third parties.

SCYNEXIS is a biotechnology company, headquartered in Jersey City, New Jersey, 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.

The Company is developing its proprietary class of triterpenoid antifungal compounds (“fungerps") as broad-spectrum, systemic antifungal agents for multiple fungal indications.

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.

The Company licensed the rights for ibrexafungerp to GlaxoSmithKline Intellectual Property (No.

3) Limited (“GSK”) via 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”).

See Note 8 for further details.

Following a review in 2023 by GSK of the manufacturing process and equipment at the vendor that manufactures the ibrexafungerp drug substance, the Company became aware that exetimibe, a non-antibacterial beta-lactam drug substance, was manufactured using equipment common to the manufacturing process for ibrexafungerp.

In the absence of the recommended segregation, there is a risk of cross contamination.

It is not known whether any ibrexafungerp has been contaminated with a beta-lactam compound and the Company has not received reports of any adverse events due to the possible beta-lactam cross contamination.

Nonetheless, out of an abundance of caution and in line with GSK’s recommendation, the Company recalled BREXAFEMME® (ibrexafungerp tablets) from the market and placed a temporary hold on clinical studies of ibrexafungerp, including the Phase 3 MARIO study.

The clinical hold and recall affected the Company's Phase 3 MARIO study.

The hold did not impact the completed FURI, CARES, VANQUISH and SCYNERGIA clinical studies.

The Company's clinical stage compound, SCY-247, is not affected by these developments.

The Company is 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 the Company is substantially complete with the product recall.

In September 2023, after the Company announced its voluntary clinical hold, the FDA concurred with the Company's voluntary hold and placed a clinical hold.

The Company is working on the resolution of this issue and it anticipates the restart of the Phase 3 MARIO study, after the FDA's lifting of the clinical hold, in the second quarter of 2025.

A second generation fungerp SCY-247 is currently being evaluated in clinical trials and additional compounds from the Company's proprietary fungerp platform, targeted to address significant unmet needs, are in earlier stages of development.

The Company recently completed the single and multiple ascending dose portions of the ongoing Phase 1 study of oral SCY-247.

Following the positive results of the oral formulation, the Company initiated a Phase 1 study of the intravenous formulation in the first quarter of 2026.

A clinical proof-of-concept Phase 2 study of SCY-247 in patients with invasive candidiasis ("IC") is also anticipated in 2026.

Subsequent stages of development 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.

The Company owns 100% of the rights to SCY-247 as well as the additional fungerp compounds.

The FDA has granted Qualified Infectious Disease Product status and Fast Track designations for SCY-247 which would provide regulatory exclusivity of at least 10 years , if approved.

The Company had an accumulated deficit of $ 385.1 million at December 31, 2025.

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(1) its ability to raise additional capital through equity offerings, debt financings, or other non-dilutive third-party funding;

(2) costs associated with new or existing strategic alliances, or licensing and collaboration arrangements;

(3) negative regulatory events or unanticipated costs related to its development of ibrexafungerp and SCY-247;

(4) its ability to successfully achieve the development, regulatory, and commercial milestones under its GSK License Agreement;

(2) costs associated with new strategic alliances, or new and existing licensing and collaboration arrangements;

(3) negative regulatory events or unanticipated costs related to its development of SCY-247;

and (4) any other unanticipated material negative events or costs.

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Intercompany balances and transactions are eliminated in consolidation.

Nasdaq Minimum Bid Price Notification

On June 20, 2025, the Company received a letter from the Listing Qualifications Department staff (the "Staff") of the Nasdaq notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company's common stock was below the $ 1.00 per share minimum required for continued listing on the Nasdaq Global Market as set forth in Nasdaq Listing Rule 5450(a)(1).

The letter from Nasdaq had no immediate effect on the listing of the Company's common stock on the Nasdaq Global Market.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company had 180 calendar days from June 20, 2025, or until December 17, 2025, to regain compliance with the minimum bid price rule.

In December 2025, the Company announced that it had received an additional 180-calendar-day extension from the Nasdaq to regain compliance with the minimum bid price requirement, as outlined in Nasdaq Listing Rule 5550(a)(2).

The Company now has until June 15, 2026, to meet the requirement for the Company's shares of common stock to maintain a closing bid price of at least $ 1.00 per share for a minimum of ten consecutive business days.

Nasdaq granted the extension after determining that the Company continues to meet all other continued listing criteria for the Nasdaq Capital

Market, including the market value of publicly held shares, and the Company has provided written notice of its intention to cure the deficiency within the extension period, if necessary, through a reverse stock split.

Use of Estimates

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revenue recognition including the identification of performance obligations in licensing arrangements;

estimates for the relative standalone selling price and measure of progress under the input method for the GSK License Agreement;

estimates for product recall reserves;

determination of the fair value of stock-based compensation grants;

the estimate of services and effort expended by third-party research and development service providers used to recognize research and development expense;

and the estimates and assumptions utilized in measuring the fair value of the outstanding warrants each reporting period.

determination of the fair value of stock-based compensation grants;

and the estimates and assumptions utilized in measuring the fair value of the warrant liability each reporting period.

Summary of Significant Accounting Policies

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Allowance for Credit Losses

The Company reviews its held-to-maturity investments for credit losses on a collective basis by major security type and in line with the Company's investment policy.

As of December 31, 2024, the Company's held-to-maturity investments were in corporate bonds and agency bonds, are highly rated, and the Company does not have a history of credit losses in these investments.

The Company reviews its held-to-maturity investments quarterly for credit losses on a collective basis by major security type and in line with the Company's investment policy.

The Company monitors the credit quality of its held-to-maturity investments through the use of credit ratings.

As of December 31, 2025 and 2024, the Company's held-to-maturity investments were in corporate bonds and agency bonds, are highly rated, and the Company does not have a history of credit losses in these investments.

The Company reviews the credit quality of its license agreement receivable and license agreement contract asset by monitoring the aging of its accounts receivable, the history of write offs for uncollectible accounts, and the credit quality of its significant customers, the current economic environment/macroeconomic trends, supportable forecasts, and other relevant factors.

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As of December 31, 2025 and 2024, the Company did no t recognize a credit loss allowance for its investments, license agreement receivable, or license agreement contract asset.

Revenue Recognition

Revenue Recognition and License Agreement Revenue

The Company accounts for revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”).

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The Company only recognizes revenue when it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services that will be transferred to the customer.

License Agreement Revenue

The Company has entered into arrangements involving the sale or license of intellectual property and the provision of other services.

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If the Company determines that an arrangement includes goods or services that are central to the Company’s business operations for consideration, the Company will then identify the performance obligations in the contract using the unit of account guidance in ASC 606.

For a distinct unit of account that is within the scope of ASC 606, the Company applies all of the accounting requirements in ASC 606 to that unit of account, including the recognition,

measurement, presentation and disclosure requirements.

For a distinct unit of account that is within the scope of ASC 606, the

Company applies all of the accounting requirements in ASC 606 to that unit of account, including the recognition, measurement, presentation and disclosure requirements.

For a distinct unit of account that is not within the scope of ASC 606, the Company will recognize and measure the distinct unit of account based on other authoritative ASC topics or on a reasonable, rational, and consistently applied policy election.

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The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time.

Any change made to estimated progress towards completion of a performance obligation and, therefore, license agreement revenue recognized will be recorded as a change in estimate.

Any change made to estimated progress towards completion of a performance obligation is recorded as a change in estimate to license agreement revenue.

In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

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The Company will recognize consideration related to sales-based milestone and royalties when the subsequent sales occur pursuant to the royalty exception under ASC 606 because the license is the predominant item to which the royalties or sales-based milestone relate.

Product Revenue, Net

The Company sells BREXAFEMME primarily to wholesalers in the United States and are initially invoiced at contractual list prices.

These wholesalers subsequently resell BREXAFEMME to specialty and other retail pharmacies.

In addition to agreements with the wholesalers, the Company enters into arrangements with third-party payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts for the purchase of BREXAFEMME.

The transaction price for product sales is reduced by variable consideration related to certain gross to net (“GTN”) adjustments, including chargebacks, rebates, discounts, incentives, and returns, and the Company will estimate the amount of this variable consideration that should be included in the transaction price using the expected value method.

Specific considerations around the Company’s product revenue GTN adjustments are as follows:

• Voluntary Patient Assistance Programs – Through vendors, the Company offers copay assistance to provide financial assistance to patients for the portion of their prescription cost that is not covered by payors.

The reduction in product revenue due to the copay programs is based on an estimate of claims and costs per claim that the Company expects to receive associated with product revenue that has been recognized.

This includes potential product revenue that remains in the distribution channel at the end of a reporting period.

• Trade Discounts and Wholesaler Fees – The Company offers discounts and pays certain distributor service fees.

These are recorded as a reduction in product revenue based on distributors’ purchases and the applicable discount rate.

• Product Stocking Fees – During the initial launch of BREXAFEMME, the Company offered additional fees to wholesalers and certain indirect customers to incent stocking at wholesalers and pharmacies.

These were recorded as a reduction in product revenue based on these customer’s purchases during the eligible period and limited to a certain volume.

• Product Returns – Generally, the Company's customers have the right to return products during the 18-month period beginning six months prior to the labeled expiration date and ending twelve months after the labeled expiration date.

Since the Company has a limited history of BREXAFEMME returns, the Company estimated returns based on specific

lot expiration dates and industry data for comparable products in the market.

BREXAFEMME has a thirty-month shelf life.

• Chargebacks – For certain entities, pricing on BREXAFEMME is extended below wholesaler list price.

Entities that purchase BREXAFEMME from wholesalers at the lower program price then remit the Company the difference between their acquisition cost and the lower program price, resulting in a reduction of product revenue.

Accounts receivable is reduced for the estimated amount of unprocessed chargeback claims attributable to sale.

• Commercial Rebates – The Company contracts with commercial payors such as insurers and PBMs and offer rebates for utilization and formulary status.

These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue.

• Government Rebates – The Company is subject to discount obligations under state Medicaid programs, Medicare, and other government programs.

Provisions for government rebates are based on the estimated amount of rebates and incentives to be claimed on the related sales from the period.

These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue.

For Medicare, the Company must also estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program.

The Company determined that performance obligations are satisfied and product revenue is recognized when a customer takes control of the Company’s product, which occurs at a point in time.

This occurs upon delivery of BREXAFEMME to customers, at which point the Company recognizes revenue.

Payment is typically received 70 to 90 days after satisfaction of the Company’s performance obligations.

Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer.

The transaction price for product sales is reduced by variable consideration related to chargebacks, rebates, discounts, incentives, and returns.

The Company will estimate the amount of variable consideration that should be included in the transaction price using the expected value method.

These estimates take into consideration prescription demand from commercial providers, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns, and historical trends.

These provisions reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract.

The amount of variable consideration that is included in the transaction price may be constrained and is included in net sales only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.

Actual amounts of consideration ultimately received may differ from the Company’s estimates.

If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.

Sales commissions and other incremental costs of obtaining customer contracts are expensed as incurred as the amortization periods would be less than one year .

Product Recall

The Company establishes reserves for product recalls on a product-specific basis when circumstances giving rise to the recall become known.

The Company estimates product recalls from consumers and customers across distribution channels, utilizing third-party data and other assumptions, and these are recorded as a reduction to revenue on the Company’s consolidated statement of operations.

Additionally, the Company estimates costs for any additional fees, including but not limited to freight and destruction charges for recalled products and costs incurred by third party vendors.

These expenses are recorded within selling, general, and administrative expenses within the Company’s consolidated statement of operations as they are in excess of the initial revenue recognized.

As of December 31, 2024 and 2023, the Company maintained a products recall reserve of $ 0.6 million and $ 1.9 million, respectively, specifically for the voluntary recall of certain lots of BREXAFEMME.

The Company reviews the product recall reserve for adequacy and adjusts the product recall accrual, if necessary, based on actual experience and estimated costs to be incurred.

Cost of Product Revenues

The cost of product revenues consists primarily of inventory impairment expense, distribution, freight costs, royalty costs, and other manufacturing costs.

In September 2023, the Company announced after becoming aware of a risk of potential cross-contamination during the manufacture of ibrexafungerp, the Company was recalling BREXAFEMME from the market and placing a temporary hold on the clinical studies of ibrexafungerp.

In December 2023, the Company and GSK entered into a Binding MOU for amendment to the GSK License Agreement.

The GSK License Agreement was being amended in connection with the delay in the commercialization of BREXAFEMME and further clinical development of ibrexafungerp associated with this event.

In evaluating the recoverability of the Company's raw material inventory on hand as of December 31, 2023 given the product recall and Binding MOU, the Company considered the likelihood that revenue will be obtained from the future sale of the related inventory, discussions with regulatory agencies, and other information currently available to the Company.

For the year ended December 31, 2023, the Company recognized an impairment loss on the recoverability of its raw material inventory of approximately $ 14.6 million given the Company does not believe the inventory can be sold for commercial or development activities.

The $ 14.6 million impairment expense has been recognized in cost of product revenue in the accompanying statement of operations.

Warrant Liabilities

The Company accounts for the warrants associated with the December 2020 public offering and April 2022 Public Offering as liabilities measured at fair value.

The fair values of these warrants have been determined using the Black-Scholes valuation model ("Black-Scholes").

For contract modifications under ASC 606, depending on whether the goods and services are distinct or sold at their stand-alone selling prices, a contract modification is accounted for either as a separate contract or a termination of the old contract, a cumulative catchup of the original contract, or a combination of the termination of the old contract and cumulative catchup that faithfully reflects the economics of the transaction.

Warrant Liability

The Company accounts for the warrants associated with the April 2022 Public Offering as a liability measured at fair value.

The fair value of these warrants have been determined using the Black-Scholes valuation model ("Black-Scholes").

The warrants are subject to remeasurement at each balance sheet date, using Black-Scholes, with any changes in the fair value of the outstanding warrants recognized in the accompanying consolidated statements of operations.

Convertible Debt and Derivative Liability

In connection with the Company’s issuance of its March 2019 6.0 % Convertible Senior Notes (the “March 2019 Notes”), the Company bifurcated the embedded conversion option, inclusive of the interest make-whole provision and make-whole fundamental change provision, and recorded the embedded conversion option as a derivative liability in the Company’s balance sheet in accordance with ASC 815, Derivatives and Hedging .

The convertible debt and the derivative liability associated with the March 2019 Notes is presented in total on the consolidated balance sheet as the convertible debt and derivative liability.

The convertible debt is carried at amortized cost.

The derivative liability will be remeasured at each reporting period using the binomial lattice model with changes in fair value recorded in the consolidated statements of operations in other expense (income).

See Note 6 and 12 for further details.

Research and Development

Major components of research and development costs include clinical trial activities and services, including related drug formulation, manufacturing, and other development, preclinical studies, cash compensation, stock-based compensation, fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf, materials and supplies, certain legal services, and regulatory compliance.

The Company is required to estimate its expenses resulting from its obligations under contracts with clinical research organizations, clinical site agreements, vendors, and consultants in connection with conducting ibrexafungerp and SCY-247 clinical trials and preclinical development.

The Company is required to estimate its expenses resulting from its obligations under contracts with clinical research organizations, clinical site agreements, vendors, and consultants in connection with conducting SCY-247 and ibrexafungerp clinical trials and preclinical development.

The financial terms of these contracts are subject to negotiations which vary from contract to contract, and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts.

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For clinical trials, the Company accounts 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.

For preclinical development services performed by outside service providers, the Company determines accrual estimates through financial models, taking into account development progress data received from outside service providers and discussions with applicable Company and service provider personnel.

For preclinical development services performed by outside service providers, the

Company determines accrual estimates through financial models, taking into account development progress data received from outside service providers and discussions with applicable Company and service provider personnel.

Patent Expenses

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Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability.

The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to

their initial measurement.

The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs when determining fair value.

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• Level 3 — Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions about the assumptions market participants would use in pricing the asset or liability based on the best information available in the circumstances.

Amortization of Debt Issuance Costs and Discount

The Company’s convertible debt is recorded net of debt issuance costs and discount which comprised issuance costs and an advisory fee, and the discount initially recognized for the fair value of the bifurcated derivative liability.

The portion of the debt issuance costs allocated to the convertible debt, based on the amount of proceeds allocated between the convertible debt and the derivative liability, is being amortized over the term of the convertible debt using the effective interest method in addition to the discount initially recognized for the fair value of the bifurcated derivative liability from the convertible debt.

The Company’s loan payable was recorded net of debt discount which comprised issuance costs, customary closing and final fees, and the fair value of the warrants issued in conjunction with the loan payable.

The resulting debt discount was being amortized over the term of the loan payable using the effective interest method until the loan payable was fully repaid in May 2023.

The amortization of debt issuance costs and discount is included in other expense within the accompanying consolidated statements of operations.

The Company provides for deferred income taxes under the asset and liability method, whereby deferred income taxes result from temporary differences between the tax bases of assets and liabilities and their reported amounts in the consolidated financial statements.

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The Company recognize forfeitures as they are incurred.

Basic and Diluted Net (Loss) Income per Share of Common Stock

The Company calculates net (loss) income per common share in accordance with ASC 260, Earnings Per Share .

Basic net (loss) income per common share for the years ended December 31, 2024 and 2023 was determined by dividing net (loss) income applicable to common stockholders by the weighted average number of common shares outstanding during the period.

Per ASC 260, Earnings Per Share , the weighted average number of common shares outstanding utilized for determining the basic net (loss) income per common share for the years ended December 31, 2024 and 2023 includes the outstanding prefunded warrants to purchase 7,516,267 and 3,200,000 shares of common stock issued in the April 2022 Public Offering and December 2020 public offering, respectively.

Diluted net (loss) income per common share for the years ended December 31, 2024 and 2023 was determined as follows (in thousands, except share and per share amounts):

Years Ended December 31,

Net (loss) income allocated to common shares

Weighted average common shares outstanding – basic

Dilutive effect of restricted stock units

Weighted average common shares outstanding – diluted

Net (loss) income per share – diluted

The following potentially dilutive shares of common stock and outstanding restricted stock units that contain certain performance contingencies have not been included in the computation of diluted net (loss) income per share for the years ended December 31, 2024 and 2023, as the result would be anti-dilutive or the performance contingencies have not been met:

Basic and Diluted Net Loss per Share of Common Stock

The Company calculates net loss per common share in accordance with ASC 260, Earnings Per Share .

Basic net loss per common share for the years ended December 31, 2025 and 2024 was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period.

Per ASC 260, Earnings Per Share , the weighted average number of common shares outstanding utilized for determining the basic net loss per common share for the years ended December 31, 2025 and 2024 includes the outstanding prefunded warrants to purchase 3,189,815 and 3,200,000 shares of common stock issued in the April 2022 Public Offering and December 2020 public offering, respectively.

The following potentially dilutive shares of common stock have not been included in the computation of diluted net loss per share for the years ended December 31, 2025 and 2024, as the result would be anti-dilutive:

Years Ended December 31,

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Outstanding restricted stock units

Warrants to purchase common stock associated with December 2020 public offering - Series 2

Warrants to purchase common stock associated with April 2022 Public Offering

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The Company’s chief operating decision maker (“CODM”) is the Chief Executive Officer.

The CODM reviews consolidated net (loss) income to make decisions about allocating resources and assessing performance for the entire Company.

The CODM reviews consolidated net loss to make decisions about allocating resources and assessing performance for the entire Company.

The Company views its operations and manages its business as one operating segment, drug development.

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Reclassification of Prior Year Amounts

Certain prior year amounts within the accrued expenses and income tax footnote disclosures have been reclassified for consistency with the current year presentation.

Certain prior year amounts within the income tax footnote disclosures have been reclassified for consistency with the current year presentation.

Recently Adopted Accounting Pronouncements

In November 2023, the FASB issued ASU No.

2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures , which introduced new guidance on disclosures for reportable segments and significant segment expenses, including for entities with a single reportable segment.

This guidance is effective for the Company for annual reporting periods beginning January 1, 2024 and interim periods beginning January 1, 2025.

The Company adopted ASU 2023-07 in the current annual period.

In August 2020, the FASB issued ASU No.

2020-06, Debt—Debt with Conversion and Other Options and Derivatives and Hedging—Contracts in Entity’s Own Equity:

Accounting for Convertible Instruments and Contracts in and Entity’s Own Equity .

The amendments in ASU 2020-06 reduce the number of accounting models for convertible debt instruments and revises certain guidance relating to the derivative scope exception and earnings per share.

The amendments in ASU 2020-06 are effective for public business entities that meet the definition of a SEC filer and a smaller reporting company for fiscal years beginning after December 15, 2023, and interim periods within those years.

As a smaller reporting company, the Company adopted ASU 2020-06 in the current annual period.

In December 2023, the FASB issued ASU No.

2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures , which introduced new guidance on disclosures for income taxes, including enhancements to the rate reconciliation and income taxes paid disclosures.

This guidance is effective for the Company for annual reporting periods beginning January 1, 2025.

The Company adopted ASU No.

2023-09 in 2025.

Recently Issued Accounting Pronouncements

In December 2025, the FASB issued ASU No.

2025-12, Codification Improvements , which introduced new guidance on improvements to several topics within the codification.

This guidance is effective for the Company for annual reporting periods beginning after December 15, 2026.

The Company is currently evaluating the impact ASU 2025-12 will have on its consolidated financial statements.

In November 2025, the FASB issued ASU No.

2025-11, Interim Reporting (Topic 270):

Narrow-Scope Improvements , which introduced new guidance on disclosures to provide clarity about the current requirements for interim reporting.

This guidance is effective for the Company for interim reporting periods within annual reporting periods beginning after December 15, 2027.

The Company is currently evaluating the impact ASU 2025-11 will have on its consolidated financial statements.

In October 2025, the FASB issued ASU No.

2025-10, Government Grants (Topic 832):

Accounting for Government Grants Received by Business Entities , which introduced authoritative guidance on the accounting for government grants received by business entities.

This guidance is effective for the Company for annual reporting periods beginning after December 15, 2028, and interim reporting periods within those annual reporting periods.

The Company is currently evaluating the impact ASU 2025-10 will have on its consolidated financial statements.

In November 2024, the FASB issued ASU No.

2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) , Disaggregation of Income Statement Expenses , which introduced new guidance on disclosures for specified costs and expenses.

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The Company is currently evaluating the impact ASU 2024-03 will have on its consolidated financial statements.

In December 2023, the FASB issued ASU No.

This guidance is effective for the Company for annual reporting periods beginning January 1, 2025.

As a smaller reporting company, the Company is currently evaluating the impact ASU 2023-09 will have on its consolidated financial statements.

I nvestments consisted of the following (in thousands):

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The Company has evaluated the unrealized loss position in the corporate bonds as of the balance sheet dates and did not consider it to be indicative of an other-than-temporary impairment as the securities are highly-rated and the Company expects to realize the full principal amount at maturity.

As of December 31, 2025, the corporate bonds maintain credit ratings of A- and higher.

Prepaid Expenses and Other Current Assets

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Total accrued expenses

March 2019 Note Purchase Agreement

On March 7, 2019 , the Company entered into a Senior Convertible Note Purchase Agreement (the “March 2019 Note Purchase Agreement”) with Puissance.

Pursuant to the March 2019 Note Purchase Agreement, on March 7, 2019, the

Company issued and sold to Puissance $ 16.0 million aggregate principal amount of its March 2019 Notes, resulting in $ 14.7 million in net proceeds after deducting $ 1.3 million for an advisory fee and other issuance costs.

As of December 31, 2024 and 2023, the Company’s March 2019 Notes consists of the convertible debt balance of $ 13.7 million and $ 12.0 million and the bifurcated embedded conversion option derivative liability of zero and $ 0.2 million, respectively.

In connection with the Company’s issuance of its March 2019 Notes, the Company bifurcated the embedded conversion option, inclusive of the interest make-whole provision and make-whole fundamental change provision, and recorded the embedded conversion option as a long-term derivative liability in the Company’s balance sheet in accordance with ASC 815, Derivatives and Hedging , at its initial fair value of $ 7.0 million as the interest make-whole provision is settled in shares of common stock.

For the years ended December 31, 2024 and 2023, the Company recognized a gain of $ 0.2 million and an expense of $ 0.2 million on the fair value adjustment for the derivative liability, respectively.

For the years ended December 31, 2024 and 2023, the Company recognized $ 1.7 million and $ 1.0 million, respectively, in amortization of debt issuance costs and discount, related to the March 2019 Notes.

The March 2019 Notes were issued and sold for cash at a purchase price equal to 100 % of their principal amount, in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), due to the March 2019 Notes being issued to one financially sophisticated investor.

The March 2019 Notes bear interest at a rate of 6.0 % per annum payable semiannually in arrears on March 15 and September 15 of each year, beginning September 15, 2019.

The March 2019 Notes will mature on March 15, 2025 , unless earlier converted, redeemed or repurchased.

The March 2019 Notes constitute general, senior unsecured obligations of the Company.

The holder of the March 2019 Notes may convert their March 2019 Notes at their option at any time prior to the close of business on the business day immediately preceding March 15, 2025 into shares of the Company’s common stock.

The initial conversion rate is 73.9096 shares of common stock per $ 1,000 principal amount of March 2019 Notes, which is equivalent to an initial conversion price of approximately $ 13.53 and is subject to adjustment in certain events described in the March 2019 Note Purchase Agreement.

The Holder upon conversion may also be entitled to receive, under certain circumstances, an interest make-whole payment payable in shares of common stock.

In addition, following certain corporate events that occur prior to the maturity date, the Company will, in certain circumstances, increase the conversion rate if the holder elects to convert its March 2019 Notes in connection with such a corporate event.

Subject to adjustment in the conversion rate, the number of shares that the Company may deliver in connection with a conversion of the March 2019 Notes, including those delivered in connection with an interest make-whole payment, will not exceed a cap of 81 shares of common stock per $ 1,000 principal amount of the March 2019 Notes.

Loan Agreement

The Company was party to a Loan and Security Agreement, dated May 13, 2021, with Hercules Capital, Inc.

("Hercules Capital") and Silicon Valley Bridge Bank, N.A.

(as successor to Silicon Valley Bank) (“SVBB”) (the "Loan Agreement"), pursuant to which Hercules Capital, SVBB and each of the other lenders from time-to-time party to the Loan Agreement (collectively, the “Lenders”) loaned to the Company $ 35.0 million as of March 31, 2023.

In connection with the entering into of the GSK License Agreement, the Company entered into a First Amendment and Consent to Loan and Security Agreement with the Lenders pursuant to which the Lenders consented to the Company entering into the GSK License Agreement and the Company agreed to pay to the Lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement (approximately $ 35.4 million), (ii) the prepayment fee payable under the Loan Agreement ($ 262,500 ), (iii) the final payment payable under the Loan Agreement ($ 1,382,500 ), and (iv) all other sums, if any, that shall have become due and payable with respect to loan advances under the Loan Agreement.

Upon receipt by the Company of the $ 90.0 million upfront payment from GSK in May 2023, all amounts payable under the Loan Agreement were fully paid.

In connection with the repayment of those amounts due, in May 2023, the Company and the Lenders executed a payoff letter confirming the amounts due under the Loan Agreement, and the Company’s confirmation that the Loan Agreement was terminated.

During the year ended December 31, 2023, the Company recognized $ 1.9 million in amortization for the remaining debt issuance costs and discount associated with the loan payable with Hercules and SVBB which was fully repaid by the Company in May 2023.

Commitments and Contingencies

Commitments, Contingencies, and Borrowings

On March 1, 2018, the Company entered into a long-term lease agreement for approximately 19,275 square feet of office space in Jersey City, New Jersey, that the Company identified as an operating lease under ASC 842 (the “Lease”).

The lease term is eleven years from August 1, 2018, the commencement date, with total lease payments of $ 7.3 million over the lease term.

The lease term is eleven years from August 1, 2018, the commencement date, with total lease payments of $ 7.3 million over the lease

The Company has the option to renew for two consecutive five-year periods from the end of the first term and the Company is not reasonably certain that the option to renew the Lease will be exercised.

Under the Lease, the Company furnished a security deposit in the form of a standby letter of credit in the amount of $ 0.3 million, which will be reduced by

fifty-five thousand dollars every two years for ten years after the commencement of the lease .

Under the Lease, the Company furnished a security deposit in the form of a standby letter of credit in the amount of $ 0.3 million, which will be reduced by fifty-five thousand dollars every two years for ten years after the commencement of the lease .

The security deposit is classified as restricted cash in the accompanying consolidated balance sheets.

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In January 2014, Merck assigned the patents related to ibrexafungerp that it had exclusively licensed to the Company.

Ibrexafungerp is the Company's lead product candidate.

Pursuant to the terms of the license agreement, Merck was originally eligible to receive milestone payments from the Company that could total $ 19.0 million upon occurrence of specific events, including initiation of a Phase 2 clinical study, new drug application, and marketing approvals in each of the U.S., major European markets, and Japan.

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In December 2014, the Company and Merck entered into an amendment to the license agreement that deferred the remittance of a milestone payment due to Merck, such that no amount would be due upon initiation of the first Phase 2 clinical trial of a product containing the ibrexafungerp compound (the “Deferred Milestone”).

The amendment also increased, in an amount equal to the Deferred Milestone, the milestone payment that would be due upon initiation of the first Phase 3 clinical

trial of a product containing the ibrexafungerp compound.

The amendment also increased, in an

amount equal to the Deferred Milestone, the milestone payment that would be due upon initiation of the first Phase 3 clinical trial of a product containing the ibrexafungerp compound.

In December 2016 and January 2018, the Company entered into second and third amendments to the license agreement with Merck which clarified what would constitute the initiation of a Phase 3 clinical trial for the purpose of milestone payment.

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Legal Proceedings

On November 7, 2023, a securities class action was filed by Brian Feldman against the Company and certain of the Company's executives in the United States District Court, District of New Jersey, alleging that, during the period from March 31, 2023 to September 22, 2023, the Company made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects, alleging specifically that the Company 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 the Company 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, the Company were reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies;

and (4) as a result of the foregoing, the Company's statements about its 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 the Company's common stock between March 31, 2023 to September 22, 2023.

The Company has filed a motion to dismiss.

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 the Company’s directors and certain of its officers and assert state and federal claims based on the same alleged misstatements as the securities class action complaint.

These cases were consolidated and are currently stayed.

The Company disagrees with the allegations and intends to defend these litigations vigorously.

The Company has not recognized any expense for these contingencies .

The court granted the Company’s 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 without prejudice the related consolidated shareholder derivative action.

March 2019 Note Purchase Agreement

On March 7, 2019 , the Company entered into a Senior Convertible Note Purchase Agreement (the “March 2019 Note Purchase Agreement”) with Puissance Life Science Opportunities Fund VI ("Puissance").

Pursuant to the March 2019 Note Purchase Agreement, on March 7, 2019, the Company issued and sold to Puissance $ 16.0 million aggregate principal amount of its 6.0% Senior Convertible Notes due 2025 (“March 2019 Notes”), resulting in $ 14.7 million in net proceeds after deducting $ 1.3 million for an advisory fee and other issuance costs.

In April 2019, Puissance converted $ 2.0 million of the March 2019 Notes for 162,600 shares of common stock.

The March 2019 Notes matured on March 15, 2025 and the Company repaid the $ 14.0 million due to Puissance.

Stockholders’ Equity

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Outstanding restricted stock units

Warrants to purchase common stock associated with December 2020 public offering - Series 2

Prefunded warrants to purchase common stock associated with December 2020 public offering

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For possible future issuance under 2024 Plan (Note 10)

For possible future issuance under 2024 Plan (Note 11)

For possible future issuance under employee stock purchase plan

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The Company is not obligated to make any sales of common stock under the Sales Agreement.

The offering of common stock pursuant to the Sales Agreement will terminate upon (a) the sale of all of the shares

of common stock subject to the Sales Agreement or (b) the termination of the Sales Agreement by the Company or by Cantor.

During the year ended December 31, 2024, the Company sold zero shares of its common stock under the Sales Agreement.

The offering of common stock pursuant to the Sales Agreement will terminate upon (a) the sale of all of the shares of common stock subject to the Sales Agreement or (b) the termination of the Sales Agreement by the Company or by Cantor.

During the years ended December 31, 2025 and 2024, the Company sold zero shares of its common stock under the Sales Agreement.

April 2022 Public Offering

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The prefunded warrants were recorded at their relative fair value at issuance in the stockholders’ equity section of the balance sheet and the prefunded warrants are considered outstanding shares in the basic earnings per share calculation for the years ended December 31, 2025 and 2024 given their nominal exercise price.

For the years ended December 31, 2024 and 2023, zero and 4,150,400 of the prefunded warrants from the April 2022 Public Offering were exercised for total proceeds of zero and $ 4,150 , respectively.

Public Offering Warrant Liabilities

The outstanding warrants associated with the December 2020 public offering contain a provision where the warrant holder has the option to receive cash, equal to the Black-Scholes fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities).

Due to this provision, ASC 480, Distinguishing Liabilities from Equity , requires that these warrants be classified as liabilities.

The fair values of these warrants have been determined using the Black-Scholes valuation model, and the changes in the fair value are recorded in the accompanying consolidated statements of operations.

During the year ended December 31, 2025 , a 5 % beneficial owner of the Company exercised 4,326,452 prefunded warrants from the April 2022 Public Offering, resulting in the issuance of 4,326,452 shares of the Company's common stock for proceeds of $ 4,326 .

The outstanding warrants associated with the April 2022 Public Offering meet the definition of a derivative pursuant to ASC 815, Derivatives and Hedging , and do not meet the derivative scope exception given the warrants do not qualify under the indexation guidance.

As a result, the April 2022 Public Offering warrants were initially recognized as liabilities and measured at fair value using the Black-Scholes valuation model.

During the year ended December 31, 2024 and 2023, the Company recognized a gain of $ 13.8 million and a loss of $ 3.2 million , respectively, due to the change in fair value of the warrant liabilities.

As of December 31, 2024 and 2023, the fair value of the warrant liabilities were $ 13.7 million and $ 21.8 million, respectively.

During the year ended December 31, 2025 and 2024, the Company recognized gains of $ 5.8 million and $ 13.8 million , respectively, due to the change in fair value of the warrant liability.

As of December 31, 2025 and 2024, the fair value of the warrant liability was $ 2.2 million and $ 8.0 million, respectively.

Warrant Associated with Danforth Advisors

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The warrant will expire five years from the date of the grant.

Product Revenue, Net

Net product revenue was zero and $ 1.0 million for the years ended December 31, 2024 and 2023, respectively.

Products are sold primarily to wholesalers and specialty pharmacies.

Revenue is reduced from wholesaler list price at the time of recognition for expected chargebacks, rebates, discounts, incentives, and returns, which are referred to as gross to net (“GTN”) adjustments.

These reductions are currently attributed to various commercial arrangements.

Chargebacks and discounts are recognized as a reduction in accounts receivable or as accrued expenses based on their nature and settled through the issuance of credits to the customer or through cash payments to the customer, respectively.

All other returns, rebates, and incentives are reflected as accrued expenses and settled through cash payments to the customer.

Three wholesalers comprised 44 %, 28 %, and 26 % of the Company’s gross revenue for the year ended December 31, 2023.

The following table summarizes activity in each of the Company’s product revenue provision and allowance categories as of December 31, 2024 and 2023 (in thousands):

Discounts and Chargebacks (1)

Product Returns (2)

Rebates and Incentives (3)

Product Recall (4)

Balance as of December 31, 2022

Provision related to current period revenue

Changes in estimate related to prior period revenue

Credit/payments

Balance as of December 31, 2023

Discounts and Chargebacks (1)

Product Returns (2)

Rebates and Incentives (3)

Product Recall (4)

Balance as of December 31, 2023

Changes in estimate related to prior period revenue

Credit/payments

Balance as of December 31, 2024

(1) Discounts and chargebacks include fees for wholesaler fees, prompt pay and other discounts, and chargebacks.

Discounts and chargebacks are deducted from gross revenue at the time revenues are recognized and are included as a reduction in accounts receivable or as an accrued expense based on their nature on the Company’s consolidated balance sheet.

(2) Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses on the Company’s consolidated balance sheet.

(3) Rebates and incentives include rebates and co-pay program incentives.

Provisions for rebates and incentives are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses on the Company’s consolidated balance sheets.

(4) Provisions for product recall are deducted from gross revenues to the extent of revenue recorded related to the recalled product and are included in accrued expenses on the Company’s consolidated balance sheet.

GSK License Agreement

On March 30, 2023 and as amended in December 2023, the Company entered into the GSK License Agreement.

On March 30, 2023 and as amended in December 2023 and October 2025, the Company entered into the GSK License Agreement.

Pursuant to the terms of the GSK License Agreement, the Company granted GSK an exclusive (even as to the Company and its 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 Greater China and certain other countries already licensed to third parties (the “GSK Territory”).

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The parties closed the transactions contemplated by the GSK License Agreement in May 2023.

The Company retains rights to all other assets, with GSK receiving a right of first negotiation (“ROFN”) to any other enfumafungin-derived compounds or products that the Company may control.

Under the terms of the original GSK License Agreement, the Company received a nonrefundable upfront payment of $ 90 million in May 2023.

The Company was initially also eligible to receive potential:

• regulatory approval milestone payments of up to $ 70 million;

• commercial milestone payments of up to $ 115 million based on first commercial sale in invasive candidiasis (U.S./EU);

• and sales milestone payments of up to $ 242.5 million based on annual net sales, with a total of $ 77.5 million to be paid upon achievement of multiple thresholds up through $200 million;

a total of $ 65 million to be paid upon achievement of multiple thresholds between $300 million and $500 million;

and $ 50 million to be paid at each threshold of $750 million and $1 billion.

As previously disclosed, the Company became aware that a non-antibacterial beta-lactam drug substance was manufactured using equipment common to the manufacturing process for ibrexafungerp.

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.

It is not known whether any ibrexafungerp has been contaminated with a beta-lactam compound.

Nonetheless, in light of this risk and out of an abundance of caution, BREXAFEMME (ibrexafungerp tablets) was recalled from the market and clinical studies of ibrexafungerp were placed on temporary hold.

On December 26, 2023, the Company 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 and further clinical development of ibrexafungerp associated with this event.

Under the terms of the updated GSK License Agreement, as amended by Binding MOU, the Company is now eligible to receive potential:

On December 26, 2023, the Company and GSK entered into a binding memorandum of understanding (the "Binding 2023 MOU") for amendment to the GSK License Agreement.

The GSK License Agreement was amended in connection with the delay in the commercialization of BREXAFEMME and further clinical development of ibrexafungerp.

Under the terms of the updated GSK License Agreement, as amended by the Binding 2023 MOU, the Company is now 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);

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and $ 35 / $ 35 / $ 30 million to be paid at each sales threshold of $750 million and $1 billion.

The Company 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 the Company's resumption and continued performance of the Phase 3 MARIO study after the clinical hold is lifted;

and $ 7.35 million for the successful completion of the Phase 3 MARIO study.

In the case of each of the above milestones, such milestone events are defined in the GSK License Agreement, as amended by the Binding 2023 MOU.

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The Company 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 Phase 3 MARIO study, and (3) performance obligations for the remaining research and development activities for the ongoing clinical and preclinical studies of ibrexafungerp.

The Company considers the future potential development, regulatory, and commercial milestone payments as well as sales-based milestone and royalties to be variable consideration.

(1) the license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, in the GSK Territory, which was satisfied in 2023 (2) the research and development activities for the Phase 3 MARIO study, and (3) performance obligations for the remaining research and development activities for the clinical and preclinical studies of ibrexafungerp which was satisfied in 2024.

The Company considers the future potential regulatory and commercial milestone payments as well as sales-based milestone and royalties to be variable consideration.

The Company constrains variable consideration to the extent that it is probable that it will not result in a significant revenue reversal when the uncertainty associated with the variable consideration is subsequently resolved.

The initial total transaction price was $ 136.1 million upon closing of the GSK License Agreement in May 2023, which included the initial payment of $ 90.0 million and $ 45.0 million in success-based development milestones.

Given the uncertain nature of these payments, the remaining potential development, regulatory, and commercial milestone payments from the GSK License Agreement are not included in the transaction price as they were determined to be fully constrained under ASC 606.

The Company allocated the $ 136.1 million transaction price based on relative standalone selling prices of each of the performance obligations as $ 130.1 million for the license, $ 4.8 million for the research and development activities for the Phase 3 MARIO study and $ 1.2 million for the remaining ongoing clinical and preclinical studies of ibrexafungerp.

The Company developed the estimated standalone selling price for the license using a Monte Carlo valuation analysis and for the research and development activities, the Company's utilized the estimate of costs to be incurred to fulfill its obligations associated with the performance of the research and development activities, plus a reasonable margin.

In developing this estimate for the license, the Company applied significant judgment in the determination of the significant assumptions relating to forecasted future cash flows and discount rates.

As of June 30, 2023, the Company provided all necessary information to GSK for it to benefit from the license under the license term.

Accordingly, the Company recognized $ 130.1 million in license agreement revenue at a point in time upon the transfer of the license to GSK as of June 30, 2023.

As of December 31, 2024 and December 31, 2023, the Company maintains a $ 9.5 million and $ 19.3 million license agreement contract asset associated with the success-based milestones associated with the ongoing clinical studies of ibrexafungerp.

In July 2024, the Company delivered to GSK the final clinical study reports for the completed FURI, CARES, and NATURE clinical studies, and the Company billed and received a $ 10.0 million development milestone from GSK.

The Company believes that the $ 9.5 million license agreement contract asset is collectible given the Company's probability assessment of achieving the milestones as defined in the GSK License Agreement, ongoing development activities, and other information available to the Company.

The Company reassessed the transaction price as of December 31, 2024, including estimated variable consideration included in the transaction price and the remaining milestones continued to be constrained.

The Company recognizes the revenue associated with the Phase 3 MARIO study and the remaining ongoing clinical and preclinical studies of ibrexafungerp over time using an input method.

The input method is based on the actual costs incurred as a percentage of total budgeted costs towards satisfying the performance obligation as this method provides the most faithful depiction of the Company’s performance in transferring control of the services promised to GSK and represents the Company’s best estimate of the period of the obligation.

For the years ended December 31, 2024 and 2023, the Company recognized $ 1.1 million and $ 1.7 million of license agreement revenue from the research and development activities associated with the Phase 3 MARIO study and the remaining ongoing clinical and preclinical studies of ibrexafungerp, respectively.

As of December 31, 2024, there is $ 1.6 million and $ 1.3 million of current and long-term deferred revenue, respectively, which is expected to be recognized by the end of 2026.

Pursuant to the GSK License Agreement, the Company was responsible for conducting the Phase 3 MARIO study which resumed in April 2025 after the FDA notified the Company the clinical hold of ibrexafungerp had been lifted, triggering the Company to bill a $10.0 million development milestone to GSK in the three months ended June 30, 2025.

Subsequently, GSK notified the Company of their intention to immediately terminate the study based on its purported rights under the GSK License Agreement.

In October 2025, the Company and GSK entered into a binding memorandum of understanding (the "Binding 2025 MOU") and the Company agreed to promptly wind-down and terminate the Phase 3 MARIO study and received one-time, non-refundable payments totaling $ 24.8 million from GSK in November 2025.

The Company will not receive any additional development milestone payments from GSK specifically associated with the Phase 3 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 the Company 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.

As a result, the Company recorded $ 4.4 million that was included in license agreement revenue for the year ended December 31, 2023.

The $ 4.4 million was recognized as an unbilled receivable as of December 31, 2023 and included in prepaid expenses and other current assets in the consolidated balance sheets and collected in 2024.

Until the product recall, the Company continued to sell BREXAFEMME in the GSK Territory.

The Binding 2025 MOU does not include any additional distinct goods and services and the Company 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.

The cumulative catchup includes $ 2.2 million previously recorded as deferred revenue.

The one-time, non-refundable payments totaling $ 24.8 million collected from GSK as part of the Binding 2025 MOU include $ 10.0 million to satisfy the license agreement receivable previously recognized as of June 30, 2025.

The Company recognizes the revenue associated with the MARIO study over time using an input method.

As a result of the Binding 2025 MOU, the performance obligation for the research and development activities for the Phase 3 MARIO study was substantially satisfied as of December 31, 2025.

For the year ended December 31, 2025 and 2024, the Company recognized $ 19.2 million and $ 2.8 million in license agreement revenue, respectively.

As of December 31, 2025, there was $ 0.2 million of current deferred revenue which is expected to be recognized in 2026.

As of December 31, 2024, there was $ 1.6 million and $ 1.3 million of current and long-term deferred revenue, respectively.

Product Revenue, Net

Until the product recall in 2023, the Company sold BREXAFEMME in the GSK Territory.

The Company was the principal for these transactions under ASC 606 as the Company maintained control of the BREXAFEMME inventory that was then sold to its customers.

For the year ended December 31, 2023, the Company's product revenue, net comprised of sales of BREXAFEMME that the Company sold as principal given it maintains control of BREXAFEMME product until delivery to its wholesalers at which point control is transferred.

The Company sold product as principal given it maintained control of BREXAFEMME product until delivery to its wholesalers at which point control was transferred.

For the year ended December 31, 2025, the Company 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.

Hansoh License Agreement

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The Company evaluated the Hansoh License Agreement and concluded that it was subject to ASC 606 as the Company viewed the Hansoh License Agreement as a contract with a customer as the activities were central to its business operations.

As such, the Company assessed the terms of the Hansoh License Agreement and identified one performance obligation for the licenses to research, develop, manufacture and commercialize ibrexafungerp in the Territory, including the underlying know-how related to such licenses.

The Company also evaluated options for additional goods and services included in the Hansoh License Agreement related to (1) optional technical assistance related to development, regulatory or manufacturing activities and (2) a supply agreement for ibrexafungerp.

Such options for additional goods or services were not considered to contain material rights as pricing approximated standalone selling prices and therefore the Company concluded that such options did not represent performance obligations and will be accounted for as separate transactions if and when they occur in the future.

The Company determined that the transaction price of $ 12.1 million included the fixed upfront cash payment of $ 10.0 million, an additional amount that was payable upon the transfer of certain data related to the manufacturing license, and $ 1.1 million related to withholding tax obligations that Hansoh remitted on behalf of the Company.

The remaining amounts related to the successful completion of a manufacturing batch by Hansoh and potential development milestones represent variable consideration and were constrained as it was concluded that it was not probable that a significant reversal in cumulative revenue recognized will not occur and therefore not included in the transaction price as of December 31, 2025 and 2024.

Potential commercial milestones and royalties on net product sales will be recognized in the same period that the underlying net product sales occur as they were determined to relate to the license.

The transaction price was recorded in revenue during the year ended December 31, 2021 at a point in time upon control of the license transferring to Hansoh.

The Company will reevaluate the transaction price at the end of each reporting period as uncertain events or resolved, or as other changes in circumstances occur.

Additionally, pursuant to the Hansoh License Agreement, both the Company and Hansoh agreed to make reasonable efforts to account for applicable taxes, fees, duties, levies, or similar amounts imposed on net income, franchise taxes and profits arising directly or indirectly from the activities of the Hansoh License Agreement.

To the extent Hansoh is required by applicable laws to withhold or deduct any tax on any payment to the Company, Hansoh agreed to make certain increases on payments to the Company to ensure that the Company receives a sum equal to what the Company would have received had there been no deduction or withholding.

As a result, the Company has recorded revenue and tax withholding expense primarily associated with the up-front payment received by the Company on a gross basis.

Cypralis and Waterstone License Agreements

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The Company retains the right to repurchase the portfolio assets from Cypralis if abandoned or deprioritized.

For the years ended December 31, 2024 and 2023, there was no revenue recognized associated with this agreement given the variable consideration associated with the sale of intellectual property to Cypralis was fully constrained as of December 31, 2024.

For the years ended December 31, 2025 and 2024, there was no revenue recognized associated with this agreement given the variable consideration associated with the sale of intellectual property to Cypralis was fully constrained as of December 31, 2025 and 2024.

Additionally, in October 2014 the Company entered into a license agreement with Waterstone Pharmaceutical HK Limited (or “Waterstone”) and granted Waterstone an exclusive, worldwide license to develop and commercialize certain non-strategic compounds.

The Company is entitled to receive potential milestones and royalties from Waterstone;

The Company is entitled to receive potential

milestones and royalties from Waterstone;

however, there was no revenue recognized by the Company in 2025 and 2024 associated with this agreement given the variable consideration was fully constrained as of December 31, 2025 and 2024.

The Company’s consolidated financial statements include a tax expense of $ 0.2 million and $ 0.1 million on (loss) income before taxes of $ 21.1 million and $ 67.2 million for the years ended December 31, 2024 and 2023, respectively.

The Company’s consolidated financial statements include a tax expense of zero and $ 0.2 million on domestic loss before taxes of $ 4.7 million and $ 20.5 million for the years ended December 31, 2025 and 2024, respectively, and on foreign loss before taxes of $ 3.9 million and $ 0.6 million for the years ended December 31, 2025 and 2024, respectively.

The income tax expense consisted of the following (dollars in thousands):

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Total current expense

Reconciliations of the differences between the expense for income taxes and income taxes at the statutory U.S.

federal income tax rate is as follows (dollars in thousands):

The reconciliation of the U.S.

statutory income tax rate to the Company's effective tax rate for income from continuing operations reflecting the requirements of ASU 2023-09, as adopted retrospectively, is as follows:

Percent of Pretax Income

Income taxes from continuing operations at statutory rate

State income taxes

State effect of permanent items

Permanent stock-based compensation

Deferred rate change

Warrants issuance

Expiring NOLs and credits

Milestone deferral true-up

Convertible debt amortization

federal statutory tax rate

State and local income taxes, net of federal income tax effect (a)

Foreign tax effects:

Statutory rate difference between Australia and U.S.

Changes in valuation allowance

Effects of changes in tax laws or rates enacted in current period

Research and development tax credit

Expiring credits

Changes in valuation allowance

Nontaxable or nondeductible items:

Warrant issuance

Stock compensation

Convertible debt interest

Other adjustments

Deferred stock-based compensation true-up

Increase in valuation allowance

Total income tax expense

Convertible debt interest

Milestone deferral true-up

Expiring NOLs

Effective tax rate

(a) For the year ended December 31, 2025, state taxes in the following states listed below made up the majority (greater than 50% of the tax effect):

New Jersey and Florida.

The components of deferred tax assets and liabilities as of December 31, 2025 and 2024 are as follows (in thousands):

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As of December 31, 2025, the Company had available federal research and development credit carryforwards of $ 6.2 million which began to expire in 2026 .

For the years ended December 31, 2024 and 2023, the Company paid $ 0.7 million and zero for U.S.

federal and state income taxes, respectively.

For the year ended December 31, 2025, the Company did no t pay income tax.

For the year ended December 31, 2024, the Company paid $ 0.6 million for federal income tax and $ 0.1 million for state income tax.

We completed a Section 382 study of transactions in our stock through December 31, 2023 and concluded that we have experienced ownership changes since inception that we believe under Section 382 and 383 of the Code will result in limitations on our ability to use certain pre-ownership change NOLs and credits.

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Similar provisions of state tax law may also apply to limit the use of accumulated state tax attributes.

On July 4, 2025, the One Big Beautiful Bill was enacted (“OBBBA”), introducing significant and wide-ranging changes to the U.S.

federal tax system.

Significant components include restoration of 100 % accelerated tax depreciation on qualifying property including expansion to cover qualified production property.

Another major aspect includes the return to immediate expensing of domestic research and experimental expenditures (“R&E”) which in some cases may include retroactive application back to 2021 for businesses with gross receipts of less than $ 31.0 million or accelerated tax deductions of R&E that was previously capitalized for larger businesses.

The legislation also reinstates EBITDA-based interest deductions for tax purposes and makes several business tax incentives permanent.

Less favorable business provisions include limitations on tax deductions for charitable contributions.

The OBBBA modified the U.S.

International Tax provisions for Global Intangible Low-Taxed Income (“GILTI”), Foreign-Derived Intangible Income (“FDII”), and the Base-erosion Anti-abuse Tax (“BEAT”) effective for tax years starting after December 31, 2025.

The tax rate on GILTI, now renamed to Net CFC Tested Income (“NCTI”), is now 12.6 %.

The FDII rules, now renamed to Foreign Derived Deduction Eligible Income (“FDDEI”), now carry a 14 % tax rate on FDDEI eligible income.

The OBBB Act increases the BEAT rate from 10 % to 10.5 %.

On December 22, 2017, the “Tax Cuts and Jobs Act” was signed into law.

The tax reform has the following effects on the Company:

(1) permanently reduces the maximum corporate income tax rate from 35 % to 21 % effective for tax years beginning after December 31, 2017, (2) allows temporary 100 % expensing for certain business assets and property placed in service after September 27, 2018 and before January 1, 2023, (3) disallows NOL carrybacks but allows for the indefinite carryforward of those NOLs which applies to losses arising in tax years beginning after December 31, 2018 and, (4) limits NOL deductions for each year equal to the lesser of the available carryover or 80 % of a taxpayer’s pre-NOL deduction taxable

This applies to losses arising in tax years ending on or after December 31, 2017.

As of December 31, 2024 and 2023, the Company has concluded that it is more likely than not that the Company will not realize the benefit of its deferred tax assets due to its history of losses.

As of December 31, 2025 and 2024, the Company has concluded that it is more likely than not that the Company will not realize the benefit of its deferred tax assets due to its history of losses since inception.

Accordingly, the net deferred tax assets have been fully reserved.

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Unrecognized tax benefit—January 1

Additions for tax positions of current period

Additions for tax positions of prior periods

Reductions for tax positions of prior years

Deferred rate change

Unrecognized tax benefit—December 31

None of the unrecognized tax benefits would, if recognized, affect the effective tax rate because the Company has recorded a valuation allowance to fully offset federal and state deferred tax assets.

The Company has no tax positions for which it is reasonably possible that the total amount of unrecognized tax benefits will significantly increase or decrease within the coming year.

The Company has $ 0 provided for interest and penalties associated with uncertain tax positions.

The Company has zero provided for interest and penalties associated with uncertain tax positions.

Stock-based Compensation

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As of December 31, 2025, there were 4,469,906 shares of common stock available for future issuance under the 2024 Plan.

Pursuant to the terms of the 2014 Plan, on January 1, 2024 and 2023, the Company automatically added 1,916,962 and 1,901,960 shares to the total number shares of common stock available for future issuance under the 2014 Plan, respectively.

2015 Inducement Plan

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During both the years ended December 31, 2025 and 2024, there were zero granted options of the Company’s common stock under the 2015 Plan.

As of December 31, 2024 and 2023, there were 637,050 and 633,590 shares of common stock available for future issuance under the 2015 Plan, respectively.

As of December 31, 2025, there were 665,634 shares of common stock available for future issuance under the 2015 Plan.

Option Valuation Method

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The Black-Scholes option-pricing model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable rather than for use in estimating the fair value of stock options subject to vesting and transferability restrictions.

Using the Black-Scholes option-pricing model, the weighted-average fair value of options granted during 2024 and 2023 was $ 1.31 and $ 1.29 per option, respectively.

Using the Black-Scholes option-pricing model, the weighted-average fair value of options granted during 2025 and 2024 was $ 0.73 and $ 1.31

per option, respectively.

The aggregate fair value of options granted during 2025 and 2024 was $ 0.6 million and $ 1.4 million, respectively.

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The intrinsic values in the table above represent the total intrinsic value (the difference between the Company’s closing stock price as of December 31, 2025, and the exercise price multiplied by the number of options).

The total fair value of shares vested for the years ended December 31, 2024 and 2023 was $ 0.9 million and $ 0.7 million, respectively.

The total fair value of shares vested for both the years ended December 31, 2025 and 2024 was $ 0.9 million.

As of December 31, 2025, there was approximately $ 1.2 million of total unrecognized compensation cost related to unvested options granted under the plans.

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RSUs generally vest 33 % annually over a three-year period from the date of grant.

Upon vesting, the RSUs generally are net share

settled to cover the required withholding tax with the remaining shares issued to the holder.

Upon vesting, the RSUs generally are net share settled to cover the required withholding tax with the remaining shares issued to the holder.

The Company recognizes compensation expense for such awards ratably over the corresponding vesting period.

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During the years ended December 31, 2025 and 2024, the Company issued 63,493 and 45,593 shares of common stock under the 2014 ESPP, respectively.

During the years ended December 31, 2024 and 2023, the number of shares of common stock available for issuance under the ESPP was increased by 2,941 and 1,502,941 shares, respectively.

As of December 31, 2024 and 2023, there were 1,431,393 and 1,474,045 shares of common stock available for future issuance under the 2014 ESPP, respectively.

As of December 31, 2025, there were 1,367,900 shares of common stock available for future issuance under the 2014 ESPP.

Compensation Cost

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Money market funds

Warrant liabilities

Warrant liability

Total liabilities

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Money market funds

Warrant liabilities

Derivative liability

Warrant liability

Total liabilities

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The fair value of cash equivalents is determined based on “Level 1” inputs, which consist of quoted prices in active markets for identical assets.

As of December 31, 2024, the cash and cash equivalents of $ 16.1 million and the restricted cash balances of $ 0.4 million and $ 0.1 million within short and long term on the balance sheet, respectively, sum to the total of $ 16.6 million as shown in the statement of cash flows.

As of December 31, 2025, the cash and cash equivalents of $ 21.3 million and the restricted cash balances of $ 0.1 million within both short and long term on the balance sheet, respectively, sum to the total of $ 21.4 million as shown in the statement of cash flows.

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The historical and implied volatility of the Company, using its closing common stock prices and market data, is utilized to reflect future volatility over the expected term of the warrants.

At December 31, 2024, the Level 3 volatility utilized in the Black-Scholes model to fair value the warrant liability was 83.4 %.

At December 31, 2023, the range and weighted average of the Level 3 volatilities utilized in the Black-Scholes model to fair value the warrant liabilities were 87.2 % to 91.0 % and 87.2 %, respectively.

The Company uses the binomial lattice valuation model to value the Level 3 derivative liabilities at inception and on subsequent valuation dates.

This model incorporates transaction details such as the Company’s stock price, contractual terms, dividend yield, risk-free rate, historical volatility, credit rating, market credit spread, and estimated effective yield.

The unobservable inputs associated with the Level 3 derivative liability are adjusted equity volatility, market credit spread, and estimated yield.

As of December 31, 2023, these inputs were 99.6 %, 1,159 basis points, and 16.3 %, respectively.

The senior convertible notes are initially fair valued using the binomial lattice model and with the straight debt fair value calculated using the discounted cash flow method.

The residual difference represents the fair value of the embedded derivative liability and the fair value of the embedded derivative liabilities are reassessed using the binomial lattice valuation model on a quarterly basis.

At December 31, 2025 and 2024, the Level 3 volatilities utilized in the Black-Scholes model to fair value the warrant liabilities were 86.1 % and 83.4 %, respectively.

A reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands):

Warrant Liabilities

Balance – January 1, 2024

Gain adjustment to fair value

Balance – December 31, 2024

Derivative Liability

Warrant Liability

Balance – January 1, 2025

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employees scheduled for and working more than 20 hours per week.

The Company may provide a discretionary match with a maximum amount of 50 % of the first 6 % of eligible participant’s compensation, which vests ratably over four years .

Contributions under the plan were approximately $ 0.2 million for both the years ended December 31, 2024 and 2023.

The Company may provide a discretionary match with a maximum amount of 50 % of the first 6 % of eligible

participant’s compensation, which vests ratably over four years .

Contributions under the plan were approximately $ 0.1 million and $ 0.2 million for the years ended December 31, 2025 and 2024, respectively.

The Company has one reportable segment which is drug development.

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The Company’s CODM is the Chief Executive Officer .

The CODM assesses performance for the drug development segment and decides how to allocate resources based on consolidated net (loss) income that also is reported on the consolidated statement of operations.

The CODM uses budget, forecast, and actual results of the consolidated net (loss) income in deciding what drug development programs to further progress with its existing and planned capital resources.

The CODM assesses performance for the drug development segment and decides how to allocate resources based on consolidated net loss that also is reported on the consolidated statement of operations.

The CODM uses budget, forecast, and actual results of the consolidated net loss in deciding what drug development programs to further progress with its existing and planned capital resources.

The measure of segment assets is reported on the balance sheet as consolidated assets.

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Intercompany balances and transactions are eliminated in consolidation.

The table below provides information about the Company's drug development segment and includes the reconciliation to consolidated net (loss) income for the years ended December 31, 2024 and 2023, respectively (in thousands).

The table below provides information about the Company's drug development segment and includes the reconciliation to consolidated net loss for the years ended December 31, 2025 and 2024, respectively (in thousands).

Clinical expense

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Interest income

Other segment (income) expense (1)

Segment net (loss) income

Reconciliation of segment net (loss) income

Other segment expense (income) (1)

Segment net loss

Reconciliation of segment net loss

Adjustments and reconciling items

Consolidated net (loss) income

(1) Other segment (income) expense includes other research and development expense, amortization of debt issuance costs and discount, other income, warrant liabilities fair value adjustment, derivative liability fair value adjustment, and cost of product revenue.

Consolidated net loss

(1) Other segment expense includes other research and development expense, amortization of debt issuance costs and discount, other income, warrant liability fair value adjustment and derivative liability fair value adjustment.

CHANGES IN AND DISAGREEMENTS WITH ACCO UNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis