Core Viewpoint - SCYNEXIS, Inc. has resumed patient dosing in the Phase 3 MARIO study for oral ibrexafungerp, a potential treatment for invasive candidiasis, after the FDA lifted a clinical hold due to manufacturing concerns [1][2]. Group 1: Study Resumption and Financial Implications - The Phase 3 MARIO study aims to evaluate ibrexafungerp as a step-down therapy from IV echinocandins for invasive candidiasis, a serious infection [1]. - The resumption of dosing triggers a $10 million milestone payment from GSK, with an additional $20 million payment due six months after dosing begins; however, there is a dispute between SCYNEXIS and GSK regarding these payments [1][6]. - Approximately 25% of the projected patients have already been enrolled in the study, indicating strong interest from the scientific community [2]. Group 2: Need for New Treatment Options - There is a significant unmet need for new antifungal treatments, particularly for Candida strains resistant to existing therapies [3]. - Experts emphasize the importance of ibrexafungerp in improving outcomes for patients with life-threatening invasive fungal infections [3]. Group 3: About Ibrexafungerp and Triterpenoid Antifungals - Ibrexafungerp is the first in a new class of triterpenoid antifungals, which are glucan synthase inhibitors with both oral and IV formulations, showing broad-spectrum activity against multidrug-resistant pathogens [4]. - Ibrexafungerp is already approved in the U.S. for vulvovaginal candidiasis and is in late-stage development for invasive candidiasis [4][7].

Ibrexafungerp clinical hold lifted by the FDA. SCYNEXIS working to resolve a disagreement with GSK involving the restart of the MARIO study. GSK remains committed to the commercialization of Brexafemme.Hansoh recently received Chinese (NMPA) approval for ibrexafungerp in the treatment of acute VVC. SCYNEXIS will receive a milestone payment from Hansoh upon commercialization as well as royalties of approximately 10% on China sales.Presented positive preclinical data for its second-generation fungerp candidat ...

PART I FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) SCYNEXIS reported a net loss of **$5.39 million** in Q1 2025, a reversal from prior year net income, with license revenue decreasing to **$0.26 million** and cash balances reducing to **$53.8 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $6,942 | $16,051 | | Total current assets | $52,221 | $72,181 | | Total assets | $67,915 | $90,643 | | Total current liabilities | $8,957 | $24,099 | | Convertible debt | $0 | $13,688 | | Total liabilities | $17,383 | $35,566 | | Total stockholders' equity | $50,532 | $55,077 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 (in thousands, except per share data) | Three Months Ended March 31, 2024 (in thousands, except per share data) | | :--- | :--- | :--- | | License agreement revenue | $257 | $1,373 | | Research and development | $5,141 | $7,212 | | Total operating expenses | $8,867 | $10,881 | | Loss from operations | ($8,610) | ($9,508) | | Net (loss) income | ($5,391) | $411 | | Net (loss) income per share – basic | ($0.11) | $0.01 | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Account | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($7,465) | ($4,007) | | Net cash provided by investing activities | $12,440 | $5,454 | | Net cash used in financing activities | ($14,084) | ($15) | | Net (decrease) increase in cash | ($9,109) | $1,432 | [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Key notes include a dispute with GSK over the MARIO study, jeopardizing a **$30 million** milestone and **$9.5 million** contract asset, the **$14.0 million** repayment of convertible debt, and an ongoing securities class action lawsuit - The FDA lifted the clinical hold on the Phase 3 MARIO study on **April 24, 2025**, but GSK subsequently notified the company of its intent to terminate the study, which SCYNEXIS disputes[20](index=20&type=chunk) - The dispute with GSK over the MARIO study could jeopardize **$30.0 million** in development milestones and potentially reverse a **$9.5 million** contract asset[20](index=20&type=chunk)[56](index=56&type=chunk) - The company repaid **$14.0 million** of its 6.0% Senior Convertible Notes upon maturity on **March 15, 2025**[40](index=40&type=chunk) - A securities class action lawsuit was filed alleging materially false statements regarding cross-contamination risks in ibrexafungerp manufacturing, which the company intends to vigorously defend[42](index=42&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the ongoing GSK dispute regarding the MARIO study, a **29%** decrease in R&D expenses to **$5.1 million**, a net loss of **$5.4 million**, and **$53.8 million** in cash, sufficient for at least 12 months of operations [Overview and MARIO Study Update](index=22&type=section&id=Overview%20and%20MARIO%20Study%20Update) The company is reinitiating its Phase 3 MARIO study for ibrexafungerp, despite GSK's disputed termination notice, aiming to dose the first patient by **June 26, 2025**, following the FDA's lifted clinical hold - The FDA lifted the clinical hold on the MARIO study on **April 24, 2025**[69](index=69&type=chunk) - GSK notified SCYNEXIS of its intent to terminate the MARIO study on **April 28, 2025**, claiming no obligation for **$30.0 million** in development milestones[69](index=69&type=chunk) - SCYNEXIS disputes GSK's termination right and is reinitiating the study, targeting the first new patient dose by **June 26, 2025**[72](index=72&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Q1 2025 saw license revenue drop to **$0.3 million**, R&D expenses decrease **28.7%** to **$5.1 million**, and a net loss of **$5.4 million** due to lower revenue and a smaller warrant liability gain Results of Operations Comparison (in thousands) | Account | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | License agreement revenue | $257 | $1,373 | (81.3)% | | Research and development | $5,141 | $7,212 | (28.7)% | | Selling, general and administrative | $3,726 | $3,669 | 1.6% | | Net (loss) income | ($5,391) | $411 | (1,411.7)% | - The **$2.1 million** decrease in R&D expenses was primarily due to a **$1.6 million** reduction in chemistry, manufacturing, and controls (CMC) expense and a **$0.8 million** decrease in clinical expense[88](index=88&type=chunk) - A **$2.9 million** gain on warrant liabilities fair value adjustment was recognized in Q1 2025, lower than the **$9.6 million** gain in Q1 2024, primarily due to a decreased stock price[93](index=93&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of **March 31, 2025**, the company held **$53.8 million** in cash and investments, deemed sufficient for at least 12 months, with **$7.5 million** used in operations and **$14.0 million** for debt repayment - The company's cash, cash equivalents, and investments totaled **$53.8 million** as of **March 31, 2025**[95](index=95&type=chunk) - Management believes current capital resources are sufficient to fund operations for at least **12 months** from the financial statements' issuance[95](index=95&type=chunk) - Net cash used in financing activities was **$14.1 million** for Q1 2025, primarily due to the **$14.0 million** repayment of convertible debt[103](index=103&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - This section is not applicable as the company qualifies as a smaller reporting company[110](index=110&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of **March 31, 2025**, with no material changes to internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were effective at a reasonable assurance level as of **March 31, 2025**[112](index=112&type=chunk) - No material changes were made to internal control over financial reporting during the three months ended **March 31, 2025**[113](index=113&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company faces a securities class action lawsuit filed **November 7, 2023**, alleging false statements regarding ibrexafungerp manufacturing cross-contamination risks, which it intends to vigorously defend - A securities class action lawsuit was filed against the company and executives on **November 7, 2023**[115](index=115&type=chunk) - Allegations claim undisclosed cross-contamination risks for ibrexafungerp manufacturing due to shared equipment and ineffective internal controls[115](index=115&type=chunk) - The company has filed a motion to dismiss and intends to vigorously defend the litigation[115](index=115&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the detailed risk factors outlined in the company's Annual Report on Form 10-K for the year ended **December 31, 2024**, with no new updates in this quarterly report - The company's risk factors are detailed in its Annual Report on Form 10-K for the year ended **December 31, 2024**[116](index=116&type=chunk) [Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including CEO and CFO certifications and Inline XBRL financial data documents - The report includes CEO and CFO certifications as required by Rule 13a-14(a) and Section 1350 of the Sarbanes-Oxley Act[117](index=117&type=chunk)[118](index=118&type=chunk)

Core Insights - SCYNEXIS, Inc. announced the presentation of preclinical efficacy data for its second-generation fungerp candidate SCY-247 at the ESCMID Global conference in Vienna, focusing on its potential to treat systemic fungal diseases and drug-resistant infections [1][2]. Company Overview - SCYNEXIS is a biotechnology company dedicated to developing innovative medicines for difficult-to-treat infections, particularly those that are increasingly drug-resistant [13]. - The company is advancing its proprietary antifungal platform known as "fungerps," with SCY-247 being a key candidate in development [12][13]. Product Development - SCY-247 is designed to combat systemic fungal diseases, particularly invasive fungal infections where resistance to existing treatments is a major concern [2]. - The compound is a second-generation antifungal from a novel class of glucan synthase inhibitors, known as triterpenoids, which are the first new class of antifungal agents approved since 2001 [12]. - SCY-247 is currently in Phase 1 of development and has shown broad-spectrum antifungal activity against multidrug-resistant pathogens [12]. Preclinical Data - SCY-247 demonstrated potent antifungal activity against clinically relevant yeast species, including Candida auris and fluconazole-resistant Candida parapsilosis [4][6]. - In vitro studies showed that SCY-247 retained activity against a majority of antifungal-resistant Candida spp isolates, including those resistant to echinocandins [6][10]. - The compound exhibited robust in vitro activity against 65 Candida auris isolates, including strains with high resistance to echinocandins [8]. Future Prospects - SCYNEXIS anticipates that the U.S. FDA may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for both its IV and oral formulations [12].

Core Viewpoint - SCYNEXIS, Inc. reported its financial results for the year ended December 31, 2024, highlighting significant developments in its antifungal drug pipeline and a notable decrease in both revenue and expenses compared to the previous year [1][5][11]. Financial Performance - Total revenue for 2024 was $3.7 million, a decrease from $130.1 million in 2023, primarily due to the recognition of license agreement revenue associated with GSK [5][11]. - Research and development expenses decreased to $26.4 million in 2024 from $30.9 million in 2023, a reduction of $4.5 million or 14.6% [6]. - Selling, general and administrative expenses also saw a decrease to $14.5 million in 2024 from $20.9 million in 2023, a decline of $6.5 million or 30.9% [9]. - The net loss for 2024 was $21.3 million, translating to a basic loss per share of $0.44, compared to a net income of $67.0 million and earnings per share of $1.40 in 2023 [11][18]. Cash Position - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $75.1 million, down from $98.0 million at the end of 2023, providing a cash runway into Q3 2026 [12][18]. Drug Development Updates - The company initiated a Phase 1 trial for its second-generation antifungal SCY-247 in December 2024, with results expected in Q3 2025 [2][7]. - SCYNEXIS is making progress towards restarting the Phase 3 MARIO trial for invasive candidiasis, pending the FDA's lifting of the clinical hold anticipated in Q2 2025 [2][6][7]. - The company received a $10 million milestone payment from GSK in 2024, linked to the delivery of final study reports from completed studies [7]. Antifungal Platform - SCYNEXIS is developing a proprietary antifungal platform known as "fungerps," with Ibrexafungerp being the first approved agent for vulvovaginal candidiasis and in late-stage development for invasive candidiasis [13][14]. - SCY-247 is positioned as a next-generation fungicide targeting multi-drug-resistant fungal infections, including Candida auris [13].

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2024 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-36365 SCYNEXIS, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2181648 (State or other jurisdiction of incor ...

JERSEY CITY, N.J., Dec. 18, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the dosing of the first cohort of subjects in its Phase 1 trial of SCY-247, the Company's second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal infections.   "We are pleased to advance our potent, second-generation ...

Core Insights - SCYNEXIS has made significant progress in its clinical trials for antifungal treatments, particularly with ibrexafungerp and SCY-247, leading to a $10 million milestone payment from GSK [1][4][7]. Financial Performance - As of Q3 2024, SCYNEXIS reported cash, cash equivalents, and investments totaling $84.9 million, projecting a cash runway into Q3 2026 [2][14]. - Revenue for Q3 2024 was $0.7 million, a decrease from $2.4 million in Q3 2023, primarily due to lower license agreement revenue [9]. - Research and development expenses increased by 25% to $8.1 million in Q3 2024 compared to $6.5 million in Q3 2023, driven by higher costs in chemistry, manufacturing, and controls [10]. - Selling, general, and administrative expenses decreased by 42% to $2.9 million in Q3 2024 from $5.0 million in Q3 2023 [11]. - The net loss for Q3 2024 was $2.8 million, or $0.06 per share, compared to a net loss of $1.8 million, or $0.04 per share, in Q3 2023 [13][20]. Clinical Development - The FURI, CARES, and NATURE trials for ibrexafungerp in refractory invasive fungal infections have been completed, with positive results leading to the milestone payment [1][4][7]. - SCY-247 has shown promising preclinical results, with a Phase 1 study expected to begin in Q4 2024 [5][6]. - The Phase 3 MARIO trial for invasive candidiasis is anticipated to restart in early 2025 [4][8]. Upcoming Events - SCYNEXIS will participate in the Guggenheim's Inaugural Global Healthcare Conference in Boston on November 12, 2024, where management will hold one-on-one meetings with investors [2][8].

Financial Performance - Total revenue for the three months ended September 30, 2024, was $660,000, a decrease of 62.5% compared to $1.76 million in the same period of 2023[81]. - License agreement revenue for the three months ended September 30, 2024, was $660,000, down 72.2% from $2.375 million in 2023[81]. - Net loss for the three months ended September 30, 2024, was $2.8 million, an increase of 59.8% compared to a net loss of $1.76 million in 2023[81]. - Total revenue for the nine months ended September 30, 2024, was $2.769 million, a significant decrease of 97.9% from $134.344 million in the same period of 2023[85]. - Research and development expenses for the nine months ended September 30, 2024, were $22.1 million, an increase of 8.6% from $20.3 million in 2023[85]. - Selling, general and administrative expenses for the nine months ended September 30, 2024, decreased by 43.8% to $9.7 million from $17.3 million in 2023[85]. - The company recognized a $0.4 million income tax benefit for U.S. federal income tax for the three months ended September 30, 2024[83]. - The amortization of debt issuance costs and discount for the three months ended September 30, 2024, was $441,000, an increase of 22.5% from $360,000 in 2023[81]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $14.1 million, a decrease of $82.0 million compared to the same period in 2023, primarily due to $115.0 million received under the GSK License Agreement in the prior period[86]. - Interest income increased to $3.4 million for the nine months ended September 30, 2024, compared to $2.6 million in the same period of 2023, driven by earnings from money market funds and investments[87]. - Interest expense decreased significantly to $0.6 million for the nine months ended September 30, 2024, down from $2.9 million in the prior year, due to the repayment of the Loan Agreement in May 2023[87]. - The company recognized a gain of $10.6 million in fair value adjustments related to warrant liabilities for the nine months ended September 30, 2024, compared to a loss of $6.0 million in the same period of 2023[87]. Research and Development - The accumulated deficit as of September 30, 2024, was $372.1 million, indicating ongoing significant research and development expenses[73]. - Ibrexafungerp, the first antifungal from SCYNEXIS's proprietary platform, has received FDA approval for treating vulvovaginal candidiasis and reducing recurrent cases[67]. - SCY-247, a second-generation antifungal, is in preclinical development, with a Phase 1 study anticipated to start in Q4 2024[67]. - Research and development expenses increased to $8.1 million for the three months ended September 30, 2024, representing a 24.9% increase from $6.5 million in 2023[81]. - The company expects to incur significant research and development expenses and may require additional capital to fund operations, which could be obtained through equity offerings, debt financings, or strategic alliances[91]. - Future capital requirements will depend on various factors, including the success of product candidates in clinical development and the ability to secure regulatory approvals[93]. Legal Matters - Legal proceedings have been initiated against SCYNEXIS regarding alleged misleading statements related to ibrexafungerp manufacturing processes[70]. - The company is facing legal proceedings related to alleged misstatements about its operations and internal controls, which could impact its financial position[95]. - A securities class action was filed on November 7, 2023, alleging materially false and misleading statements from March 31, 2023, to September 22, 2023[95]. - The class action complaint claims that the company failed to disclose risks related to cross-contamination in manufacturing processes[95]. - The complaint seeks unspecified damages on behalf of all persons who purchased shares between March 31, 2023, and September 22, 2023[95]. - Shareholder derivative complaints were filed on May 1, 2024, and June 4, 2024, based on the same alleged misstatements as the class action[95]. - The company intends to vigorously defend against the allegations made in the lawsuits[95]. Operational Updates - SCYNEXIS received a $10.0 million development milestone from GlaxoSmithKline (GSK) in Q3 2024, totaling $125.0 million received under the GSK License Agreement[67]. - A voluntary recall of BREXAFEMME was initiated due to potential cross-contamination risks, affecting ongoing clinical studies[69]. - The FDA has placed a clinical hold on ibrexafungerp studies, with plans to resolve the issue and restart the Phase 3 MARIO study in Q1 2025[69]. - SCYNEXIS has entered into new manufacturing agreements to produce ibrexafungerp batches to lift the clinical hold[69]. - As of September 30, 2024, SCYNEXIS, Inc. reported cash, cash equivalents, and investments totaling $84.9 million[73]. - As of September 30, 2024, the company had cash and cash equivalents of $84.9 million, down from $98.0 million as of December 31, 2023, with an accumulated deficit of $372.1 million[87]. - No changes in internal control over financial reporting occurred during the three months ended September 30, 2024, that materially affected internal control[94]. - The management evaluated the effectiveness of disclosure controls and procedures as of September 30, 2024, concluding they were effective at a reasonable assurance level[94].

Company Overview - SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines to combat difficult-to-treat and drug-resistant infections [3] - The company is advancing its proprietary antifungal platform known as "fungerps" [3] - Ibrexafungerp, the first drug from this novel class, has been licensed to GSK and received FDA approval for vulvovaginal candidiasis in June 2021, with a second indication approved in November 2022 [3] Upcoming Event - David Angulo, M.D., President and CEO of SCYNEXIS, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on October 17, 2024, at 11:30 A.M. ET [1] - The event will be held virtually, and investors can sign up to view the presentation [1] Clinical Development - Late-stage clinical investigations of ibrexafungerp for treating life-threatening invasive fungal infections in hospitalized patients are currently ongoing [3] - Additional antifungal compounds from the same class, including SCY-247, are in pre-clinical and discovery phases [3]