Core Insights - SCYNEXIS, Inc. reported financial results for Q2 2025, highlighting progress in its drug development pipeline and ongoing disputes with GSK regarding milestone payments [1][5][9]. Drug Development Progress - The company is advancing its second-generation fungicide candidate, SCY-247, with Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data expected to be announced in Q3 2025 [2][7]. - Positive preclinical efficacy data for SCY-247 was presented at the ESCMID meeting, showcasing its potential against difficult-to-treat fungal infections [4]. - The first new patient was dosed in the Phase 3 MARIO study after the FDA lifted the clinical hold, triggering a $10 million milestone payment from GSK [5][6]. Financial Performance - For Q2 2025, SCYNEXIS reported revenue of $1.4 million, up from $0.7 million in Q2 2024, primarily from the GSK License Agreement [9]. - Research and development expenses increased to $7.1 million in Q2 2025 from $6.8 million in Q2 2024, driven by higher costs in chemistry, manufacturing, and controls [10]. - Selling, general, and administrative expenses rose to $3.8 million in Q2 2025, a 20% increase from $3.2 million in Q2 2024, mainly due to higher professional fees [11]. - The net loss for Q2 2025 was $6.9 million, or $(0.14) per share, compared to a net loss of $14.5 million, or $(0.30) per share in Q2 2024 [13]. Cash Position - As of June 30, 2025, the company had cash, cash equivalents, and investments totaling $46.5 million, down from $75.1 million at the end of 2024, providing a cash runway into Q4 2026 [14]. Legal Developments - The U.S. District Court granted SCYNEXIS's motion to dismiss a securities class action lawsuit filed in November 2023, allowing the plaintiff to amend the complaint within 30 days [8]. Corporate Strategy - SCYNEXIS is working to transfer the New Drug Application for Brexafemme to GSK by the end of 2025, enabling GSK to initiate regulatory discussions for the product's relaunch [6][16].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period to Commission File Number 001-36365 SCYNEXIS, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpor ...

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].

The Phase 1 trial of the second-generation triterpenoid antifungal SCY-247, initiated in December of 2024, continues and results are expected in Q3 of 2025.Four presentations for SCY-247 were accepted by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) congress, April 11-15, 2025 in Vienna, Austria.SCYNEXIS continues to make progress towards the restart of the Phase 3 MARIO study in invasive candidiasis. The Company anticipates the restart, pending the FDA’s lifting of t ...

☒ 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].