Core Insights - SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines to combat difficult-to-treat and drug-resistant infections [2] Group 1: Company Overview - SCYNEXIS is pioneering a proprietary antifungal platform known as "fungerps" [2] - Ibrexafungerp, the first drug from this novel class, has been licensed to GSK and received FDA approval for vulvovaginal candidiasis (VVC) in June 2021, with a second indication approved in November 2022 for reducing recurrent VVC [2] - The company is conducting late-stage clinical investigations of ibrexafungerp for life-threatening invasive fungal infections in hospitalized patients [2] - Additional antifungal compounds from the "fungerps" class, including SCY-247, are in various stages of clinical and pre-clinical development [2] Group 2: Upcoming Events - The senior leadership team of SCYNEXIS will participate in the H.C. Wainwright 27th Annual Global Conference on September 10, 2025 [1] - The presentation will take place from 10:30 a.m. to 11:00 a.m. ET in New York, NY, and will include in-person presentations and one-on-one meetings [1]

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].

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations, and cash flows, along with detailed notes explaining the company's business, significant accounting policies, investments, accrued expenses, borrowings, stockholders' equity, stock-based compensation, fair value measurements, revenue recognition, and segment information [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Unaudited Condensed Consolidated Balance Sheets (in thousands): | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $11,020 | $16,051 | | Short-term investments | $33,765 | $43,249 | | Total current assets | $56,498 | $72,181 | | Total assets | $60,694 | $90,643 | | **Liabilities and Stockholders' Equity** | | | | Accounts payable | $6,172 | $4,569 | | Accrued expenses | $2,477 | $3,793 | | Convertible debt | $— | $13,688 | | Total current liabilities | $10,863 | $24,099 | | Warrant liability | $2,904 | $7,998 | | Total liabilities | $16,227 | $35,566 | | Total stockholders' equity | $44,467 | $55,077 | | Total liabilities and stockholders' equity | $60,694 | $90,643 | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Unaudited Condensed Consolidated Statements of Operations (in thousands, except per share data): | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | License agreement revenue | $1,364 | $736 | $1,620 | $2,109 | | Research and development | $7,141 | $6,807 | $12,282 | $14,019 | | Selling, general and administrative | $3,784 | $3,166 | $7,528 | $6,835 | | Total operating expenses | $10,925 | $9,973 | $19,810 | $20,854 | | Loss from operations | $(9,561) | $(9,237) | $(18,190) | $(18,745) | | Warrant liability fair value adjustment | $(2,166) | $5,761 | $(5,094) | $(3,848) | | Net loss | $(6,885) | $(14,458) | $(12,276) | $(14,047) | | Net loss per share – basic and diluted | $(0.14) | $(0.30) | $(0.25) | $(0.29) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Unaudited Condensed Consolidated Statements of Cash Flows (in thousands): | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(14,960) | $(14,867) | | Net cash provided by investing activities | $23,713 | $6,826 | | Net cash used in financing activities | $(14,084) | $(15) | | Net decrease in cash, cash equivalents, and restricted cash | $(5,331) | $(8,056) | | Cash, cash equivalents, and restricted cash at end of period | $11,264 | $26,537 | [Notes to the Condensed Consolidated Financial Statements (unaudited)](index=8&type=section&id=NOTES%20TO%20THE%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) [1. Description of Business and Basis of Preparation](index=8&type=section&id=1.%20Description%20of%20Business%20and%20Basis%20of%20Preparation) SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines for difficult-to-treat fungal infections, primarily through its proprietary fungerp platform. The company's lead product, ibrexafungerp (BREXAFEMME), is approved for vulvovaginal candidiasis. A significant development is the ongoing dispute with GSK regarding the MARIO study for invasive candidiasis, where GSK attempted to terminate the study despite the FDA lifting a clinical hold and the company resuming patient dosing, triggering a $10.0 million milestone payment. The company also faces liquidity challenges with an accumulated deficit and a Nasdaq minimum bid price notification - SCYNEXIS is a biotechnology company developing proprietary triterpenoid antifungal compounds ('fungerps') for difficult-to-treat and drug-resistant infections[17](index=17&type=chunk) - Ibrexafungerp (BREXAFEMME) was approved by the FDA in **2021 and 2022** for vulvovaginal candidiasis (VVC) and reduction in recurrent VVC[17](index=17&type=chunk) - The **Phase 3 MARIO study** for ibrexafungerp in invasive candidiasis resumed in **May 2025** after the **FDA lifted a clinical hold** on **April 24, 2025**[19](index=19&type=chunk)[22](index=22&type=chunk) - GSK notified the company of its intention to terminate the **MARIO study** on **April 28, 2025**, claiming no obligation for a **$30.0 million** development milestone. The company disputes GSK's **unilateral termination right**[20](index=20&type=chunk)[21](index=21&type=chunk) - The company billed a **$10.0 million** development milestone to GSK in **Q2 2025** due to the **resumption of patient dosing** in the **MARIO study**[22](index=22&type=chunk) - The company had an **accumulated deficit** of **$388.8 million** and **capital resources** of **$46.5 million** (cash, cash equivalents, and investments) as of **June 30, 2025**[24](index=24&type=chunk) - On **June 20, 2025**, the company received a **Nasdaq notification** for non-compliance with the **$1.00 minimum bid price rule**, with a compliance date of **December 17, 2025**[27](index=27&type=chunk)[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the company's accounting policies, including the calculation of basic and diluted net loss per share, and details the impact of recently adopted and issued accounting pronouncements, as well as newly enacted income tax legislation - Basic net loss per common share calculation includes outstanding prefunded warrants from **April 2022** (**7,516,267 shares**) and **December 2020** (**3,200,000 shares**) public offerings[33](index=33&type=chunk) Potentially Dilutive Shares Not Included in Diluted Net Loss Per Share (as of June 30): | Item | 2025 | 2024 | | :---------------------------------------------------- | :--------- | :--------- | | Outstanding stock options | 3,664,841 | 2,842,808 | | Outstanding restricted stock units | 3,139,084 | 3,263,345 | | Warrants to purchase common stock (April 2022 offering) | 15,000,000 | 15,000,000 | | Warrants to purchase common stock (loan agreement) | 198,811 | 198,811 | | Common stock (March 2019 Notes) | — | 1,138,200 | | Warrants to purchase common stock (Danforth) | 50,000 | 50,000 | | **Total** | **22,052,736** | **22,493,164** | - The company adopted **ASU 2023-07** (Segment Reporting) in the prior annual reporting period and **ASU 2023-09** (Income Taxes) is effective for annual periods beginning **January 1, 2025**, with no material impact expected[35](index=35&type=chunk)[36](index=36&type=chunk) - **ASU 2024-03** (Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures) is effective **January 1, 2027**, and its impact is currently being evaluated[37](index=37&type=chunk) - The **One Big Beautiful Bill Act (OBBBA)**, enacted **July 4, 2025**, is not currently expected to materially impact the company's effective tax rate or cash flows in the current fiscal year[38](index=38&type=chunk) [3. Investments](index=11&type=section&id=3.%20Investments) This note provides a summary of the company's investments, primarily in corporate and agency bonds, categorized by maturity. It details their amortized cost, unrealized gains/losses, and fair value, noting that fair values are determined using Level 2 inputs Summary of Investments (in thousands): | Category | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :----------------------- | :----------------------- | :----------------------- | | Short-term investments | $33,782 | $43,316 | | Long-term investments | $1,739 | $15,808 | | **Total Fair Value** | **$35,521** | **$59,124** | - Investments are carried at amortized cost, and their fair values are determined based on "**Level 2**" inputs[40](index=40&type=chunk) [4. Prepaid Expenses and Other Current Assets](index=12&type=section&id=4.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note details the composition of prepaid expenses and other current assets, showing a decrease from December 31, 2024, to June 30, 2025, primarily driven by a reduction in prepaid research and development services Prepaid Expenses and Other Current Assets (in thousands): | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Prepaid research and development services | $74 | $514 | | Prepaid insurance | $477 | $267 | | Other prepaid expenses | $160 | $169 | | Other current assets | $867 | $1,234 | | **Total** | **$1,578** | **$2,184** | [5. Accrued Expenses](index=12&type=section&id=5.%20Accrued%20Expenses) This note provides a breakdown of accrued expenses, indicating a decrease from December 31, 2024, to June 30, 2025, mainly due to lower accrued employee bonus compensation and research and development expenses Accrued Expenses (in thousands): | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Accrued research and development expenses | $328 | $684 | | Accrued employee bonus compensation | $834 | $1,763 | | Other accrued expenses | $757 | $788 | | Accrued product recall | $558 | $558 | | **Total** | **$2,477** | **$3,793** | [6. Borrowings and Contingencies](index=12&type=section&id=6.%20Borrowings%20and%20Contingencies) This note details the repayment of the March 2019 Senior Convertible Notes and provides updates on ongoing legal proceedings, including a securities class action and shareholder derivative complaints related to alleged misstatements about cross-contamination risks and internal controls - The **$14.0 million** principal amount of the **March 2019 Senior Convertible Notes** was fully repaid at maturity on **March 15, 2025**[44](index=44&type=chunk) - A **securities class action lawsuit**, filed **November 7, 2023**, alleges the company made misleading statements regarding cross-contamination risks in ibrexafungerp manufacturing and inadequate internal controls. The court granted the company's **motion to dismiss with leave to amend** on **July 30, 2025**[46](index=46&type=chunk) - **Shareholder derivative complaints**, filed **May and June 2024**, assert state and federal claims based on similar alleged misstatements as the class action. These cases are consolidated and stayed, with the company intending to vigorously defend them[47](index=47&type=chunk) [7. Stockholders' Equity](index=14&type=section&id=7.%20Stockholders'%20Equity) This note provides a summary of common stock activity, including shares issued and outstanding, and a detailed table of shares reserved for future issuance under various plans and warrants Common Stock Issued and Outstanding: | Date | Shares Issued and Outstanding | | :---------------- | :---------------------------- | | June 30, 2025 | 39,174,941 | | December 31, 2024 | 37,973,991 | - In **August 2025**, a **5%** beneficial owner exercised **2,750,000 prefunded warrants** from the **April 2022** public offering, resulting in the issuance of **2,750,000 common shares** for **$2,750**[48](index=48&type=chunk) Common Shares Reserved for Future Issuance: | Item | June 30, 2025 | December 31, 2024 | | :---------------------------------------------------- | :------------ | :---------------- | | Outstanding stock options | 3,664,841 | 2,905,029 | | Outstanding restricted stock units | 3,139,084 | 3,120,374 | | Prefunded warrants (Dec 2020 offering) | 3,200,000 | 3,200,000 | | Warrants (April 2022 offering) | 15,000,000 | 15,000,000 | | Prefunded warrants (April 2022 offering) | 7,516,267 | 7,516,267 | | Warrants (loan agreement) | 198,811 | 198,811 | | Warrant (Danforth) | 50,000 | 50,000 | | March 2019 Notes conversion | — | 1,138,200 | | 2024 Plan | 3,903,934 | 5,864,196 | | Employee stock purchase plan | 1,399,683 | 1,431,393 | | 2015 Plan | 649,550 | 637,050 | | **Total** | **38,722,170** | **41,061,320** | [8. Stock-based Compensation](index=16&type=section&id=8.%20Stock-based%20Compensation) This note outlines the company's equity incentive plans (2024 Plan, 2015 Plan), summarizes stock option and restricted stock unit (RSU) activity, and details the stock-based compensation expense recognized for the periods - The **2024 Equity Incentive Plan** was adopted in **April 2024** and became effective **June 19, 2024**, succeeding the 2014 Plan. As of **June 30, 2025**, **3,903,934 shares** were available under the **2024 Plan**[53](index=53&type=chunk) Restricted Stock Unit (RSU) Activity (Six Months Ended June 30, 2025): | Metric | Number of Shares | Weighted Average Grant Date Fair Value Per Share | | :-------------------------- | :--------------- | :--------------------------------------------- | | Non-vested at Dec 31, 2024 | 3,120,374 | $1.89 | | Granted | 1,485,949 | $1.05 | | Vested | (1,169,240) | $1.99 | | Forfeited | (297,999) | $1.78 | | Non-vested at June 30, 2025 | 3,139,084 | $1.46 | Stock-based Compensation Expense (in thousands): | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $202 | $216 | $417 | $411 | | Selling, general and administrative | $618 | $543 | $1,222 | $1,053 | | **Total** | **$820** | **$759** | **$1,639** | **$1,464** | [9. Fair Value Measurements](index=18&type=section&id=9.%20Fair%20Value%20Measurements) This note details the fair value measurements of financial instruments, classifying cash and money market funds as Level 1 assets and the warrant liability as a Level 3 liability. It explains the use of the Black-Scholes model for valuing the warrant liability and provides a reconciliation of its changes Financial Instruments Measured at Fair Value (in thousands): | Item | June 30, 2025 Balance | December 31, 2024 Balance | | :------------------ | :-------------------- | :-------------------- | | Cash | $448 | $3,441 | | Restricted cash | $244 | $544 | | Money market funds | $10,572 | $12,610 | | **Total Level 1 Assets** | **$11,264** | **$16,595** | | Warrant liability | $2,904 | $7,998 | | **Total Level 3 Liabilities** | **$2,904** | **$7,998** | - The **warrant liability** is a **Level 3 financial liability**, valued using the **Black-Scholes option valuation model**, incorporating **unobservable inputs** like **volatility** (**85.4%** at **June 30, 2025**, and **83.4%** at **December 31, 2024**)[59](index=59&type=chunk) Reconciliation of Level 3 Warrant Liabilities (in thousands): | Metric | Amount | | :-------------------------- | :----- | | Balance – December 31, 2024 | $7,998 | | Gain adjustment to fair value | $(5,094) | | Balance – June 30, 2025 | $2,904 | [10. Revenue](index=19&type=section&id=10.%20Revenue) This note details revenue recognition primarily from the GSK License Agreement, including the $10.0 million license agreement receivable associated with the MARIO study milestone. It also highlights the potential impact on financial statements if the dispute with GSK is not resolved favorably - Revenue is primarily derived from the **GSK License Agreement**, which grants GSK exclusive rights for ibrexafungerp in the GSK Territory[61](index=61&type=chunk)[62](index=62&type=chunk) - As of **June 30, 2025**, the company maintains a **$10.0 million license agreement receivable** from GSK, triggered by the resumption of patient dosing in the **Phase 3 MARIO study**[63](index=63&type=chunk) - If the disagreement with GSK over the **MARIO study** is not resolved favorably, the company may need to reverse the **$10.0 million receivable** and recognize remaining deferred revenue, **materially impacting financial statements**[63](index=63&type=chunk) License Agreement Revenue (in thousands): | Period | 2025 | 2024 | | :-------------------------------- | :----- | :----- | | Three Months Ended June 30, | $1,364 | $736 | | Six Months Ended June 30, | $1,620 | $2,109 | Deferred Revenue (in thousands): | Category | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Current portion | $1,770 | $1,642 | | Long-term portion | $515 | $1,294 | [11. Segments](index=19&type=section&id=11.%20Segments) The company operates as a single reportable segment focused on drug development, with the CEO serving as the chief operating decision maker. Performance is assessed based on consolidated net loss, and resources are allocated to drug development programs accordingly - The company has one **reportable segment**: drug development, managing business activities on a consolidated basis[66](index=66&type=chunk) - The **Chief Executive Officer (CEO)** is the **chief operating decision maker (CODM)**, assessing performance and allocating resources based on **consolidated net (loss) income**[66](index=66&type=chunk) Drug Development Segment Net Loss (in thousands): | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $1,364 | $736 | $1,620 | $2,109 | | Clinical expense | $2,506 | $2,274 | $4,217 | $4,762 | | Preclinical expense | $1,032 | $646 | $1,969 | $1,181 | | Chemistry, manufacturing, and controls | $1,771 | $1,484 | $2,273 | $3,580 | | Selling, general, and administrative | $3,784 | $3,166 | $7,528 | $6,835 | | Segment net loss | $(6,885) | $(14,458) | $(12,276) | $(14,047) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, including an overview of its drug development pipeline, detailed updates on the MARIO study and SCY-247 development, and discussions on liquidity, legal proceedings, and Nasdaq listing compliance. It also breaks down the components of operating results and analyzes financial performance for the three and six months ended June 30, 2025 and 2024 [Overview](index=22&type=section&id=Overview) - SCYNEXIS, Inc. is a biotechnology company focused on developing **novel antifungal agents (fungerps)** to combat **difficult-to-treat and drug-resistant infections**[70](index=70&type=chunk) - Ibrexafungerp (BREXAFEMME) is the **first approved fungerp for vulvovaginal candidiasis**, and a **second-generation fungerp, SCY-247, is currently in clinical trials**[71](index=71&type=chunk)[72](index=72&type=chunk) [MARIO Study and Clinical Hold Update](index=22&type=section&id=MARIO%20Study%20and%20Clinical%20Hold%20Update) - The **Phase 3 MARIO study** for ibrexafungerp was placed on **clinical hold** in **September 2023** due to **potential cross-contamination** at the **drug substance manufacturer's facility**[74](index=74&type=chunk) - The **FDA lifted the clinical hold** on ibrexafungerp on **April 24, 2025**, allowing the **MARIO study to resume**[75](index=75&type=chunk) - GSK notified the company of its intent to terminate the **MARIO study** on **April 28, 2025**, **disputing obligations for a $30.0 million development milestone**. The company believes GSK does not have a **unilateral termination right**[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) - **Patient dosing in the MARIO study resumed in May 2025**, **triggering a $10.0 million development milestone billed to GSK**[78](index=78&type=chunk) - The **September 2023 cross-contamination issue** also led to a **recall of all commercial BREXAFEMME supplies**, with **GSK responsible for manufacturing new supplies and reintroduction to the market**[79](index=79&type=chunk) [SCY-247 Development Update](index=24&type=section&id=SCY-247%20Development%20Update) - The company completed the **single and multiple ascending dose portions of its Phase 1 study of oral SCY-247** in **88 healthy subjects**[81](index=81&type=chunk) - Data from the **SCY-247 Phase 1 study** (**safety, tolerability, and pharmacokinetics**) is **expected to be released in the third quarter of 2025**[81](index=81&type=chunk) [Nasdaq Minimum Bid Price Notification](index=24&type=section&id=Nasdaq%20Minimum%20Bid%20Price%20Notification) - On **June 20, 2025**, the company received a **Nasdaq notification for failing to meet the $1.00 minimum bid price requirement for 30 consecutive business days**[82](index=82&type=chunk) - The company has **180 calendar days**, until **December 17, 2025**, to **regain compliance by having its common stock close at $1.00 or more for at least 10 consecutive business days**[83](index=83&type=chunk) [Class Action Lawsuit](index=24&type=section&id=Class%20Action%20Lawsuit) - A **securities class action was filed on November 7, 2023**, alleging **misleading statements regarding cross-contamination risks in ibrexafungerp manufacturing and inadequate internal controls**. The **motion to dismiss was granted with leave to amend on July 30, 2025**[84](index=84&type=chunk) - **Shareholder derivative complaints**, filed in **May and June 2024**, assert **similar claims against the company's directors and officers**; these cases are **consolidated and stayed**[85](index=85&type=chunk) [Liquidity](index=25&type=section&id=Liquidity) - As of **June 30, 2025**, the company's **principal source of liquidity was cash, cash equivalents, and investments totaling $46.5 million**[86](index=86&type=chunk) - The company had an **accumulated deficit of $388.8 million** as of **June 30, 2025**, and expects to incur **significant R&D and SG&A expenses, necessitating additional capital**[87](index=87&type=chunk) - Future funding may be obtained through **equity offerings, debt financings, non-dilutive third-party funding, strategic alliances, or licensing/collaboration arrangements**[87](index=87&type=chunk) [Collaborations and Licensing Agreements](index=25&type=section&id=Collaborations%20and%20Licensing%20Agreements) - Key licensing agreements include: **GSK (ibrexafungerp development, manufacture, commercialization)**, **Merck (ibrexafungerp rights, milestones, royalties)**, **Hansoh (ibrexafungerp in Greater China, Chinese VVC approval, milestones, ~10% royalties)**, **R-Pharm (ibrexafungerp in Russia/non-core markets)**, **Waterstone (SCY-635 for viral diseases)**, and **Cypralis (cyclophilin inhibitor assets, milestones, royalties)**[88](index=88&type=chunk) [Components of Operating Results](index=25&type=section&id=Components%20of%20Operating%20Results) [Revenue](index=25&type=section&id=Revenue) - Revenue consists of **license agreement revenue associated with GSK**[89](index=89&type=chunk) [Research and Development Expense](index=25&type=section&id=Research%20and%20Development%20Expense) - R&D expenses include costs for **preclinical/clinical trials, drug formulation, manufacturing, regulatory filings, salaries, and medical affairs**. **Ibrexafungerp and SCY-247 were the only key R&D projects**[90](index=90&type=chunk)[91](index=91&type=chunk) [Selling, General and Administrative Expense](index=26&type=section&id=Selling,%20General%20and%20Administrative%20Expense) - SG&A expenses primarily consist of **salaries, personnel-related costs, facility costs, professional fees (accounting, legal), consulting, patent fees, information systems, and marketing**[93](index=93&type=chunk) [Other Expense (Income)](index=26&type=section&id=Other%20Expense%20(Income)) - Other expense (income) includes **amortization of debt issuance costs and discount, interest income, interest expense, warrant liability fair value adjustment, and derivative liability fair value adjustment**[94](index=94&type=chunk) [Income Tax Expense](index=26&type=section&id=Income%20Tax%20Expense) - Income tax expense for the **six months ended June 30, 2024**, primarily consisted of **U.S. federal income tax**[95](index=95&type=chunk) [Results of Operations for the Three Months Ended June 30, 2025 and 2024](index=26&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) Results of Operations (Three Months Ended June 30, in thousands): | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------------------------ | :----- | :----- | :--------- | :--------- | | License agreement revenue | $1,364 | $736 | $628 | 85.3% | | Research and development | $7,141 | $6,807 | $334 | 4.9% | | Selling, general and administrative | $3,784 | $3,166 | $618 | 19.5% | | Total operating expenses | $10,925 | $9,973 | $952 | 9.5% | | Loss from operations | $(9,561) | $(9,237) | $(324) | 3.5% | | Amortization of debt issuance costs and discount | $— | $421 | $(421) | (100.0)% | | Interest income | $(510) | $(1,130) | $620 | (54.9)% | | Interest expense | $— | $197 | $(197) | (100.0)% | | Warrant liability fair value adjustment | $(2,166) | $5,761 | $(7,927) | (137.6)% | | Derivative liability fair value adjustment | $— | $(28) | $28 | (100.0)% | | Total other (income) expense | $(2,676) | $5,221 | $(7,897) | (151.3)% | | Net loss | $(6,885) | $(14,458) | $7,573 | (52.4)% | - **Research and development expenses increased by $0.3 million (5%)** due to increases in **CMC ($0.3M)** and **preclinical ($0.4M)** expenses, partially offset by decreases in salary and other R&D expenses[97](index=97&type=chunk)[99](index=99&type=chunk) - **Selling, general and administrative expenses increased by $0.6 million (20%)** primarily due to a **$0.4 million increase in professional fees**[100](index=100&type=chunk) - A **$2.2 million gain on warrant liability fair value adjustment** was recognized in **Q2 2025**, compared to a **$5.8 million loss** in **Q2 2024**, primarily due to a **decrease in the company's stock price**[103](index=103&type=chunk) [Results of Operations for the Six Months Ended June 30, 2025 and 2024](index=27&type=section&id=Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) Results of Operations (Six Months Ended June 30, in thousands): | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------------------------ | :----- | :----- | :--------- | :--------- | | License agreement revenue | $1,620 | $2,109 | $(489) | (23.2)% | | Research and development | $12,282 | $14,019 | $(1,737) | (12.4)% | | Selling, general and administrative | $7,528 | $6,835 | $693 | 10.1% | | Total operating expenses | $19,810 | $20,854 | $(1,044) | (5.0)% | | Loss from operations | $(18,190) | $(18,745) | $555 | (3.0)% | | Amortization of debt issuance costs and discount | $312 | $822 | $(510) | (62.0)% | | Interest income | $(1,305) | $(2,402) | $1,097 | (45.7)% | | Interest expense | $173 | $403 | $(230) | (57.1)% | | Warrant liabilities fair value adjustment | $(5,094) | $(3,848) | $(1,246) | 32.4% | | Derivative liabilities fair value adjustment | $— | $(196) | $196 | (100.0)% | | Total other income | $(5,914) | $(5,221) | $(693) | 13.3% | | Loss before taxes | $(12,276) | $(13,524) | $1,248 | (9.2)% | | Income tax expense | $— | $523 | $(523) | (100.0)% | | Net loss | $(12,276) | $(14,047) | $1,771 | (12.6)% | - **Research and development expenses decreased by $1.7 million (12%)** primarily due to a **$1.3 million decrease in CMC expense** and a **$0.5 million decrease in clinical expense**, partially offset by an **$0.8 million increase in preclinical expense**[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - **Selling, general and administrative expenses increased by $0.7 million (10%)** due to increases in **business development expense ($0.3M)** and **salary expense ($0.3M)**[109](index=109&type=chunk) - A **$5.1 million gain on warrant liabilities fair value adjustment** was recognized in **H1 2025**, compared to a **$3.8 million gain** in **H1 2024**, primarily due to a **decrease in the company's stock price**[112](index=112&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) [Sources of Liquidity](index=29&type=section&id=Sources%20of%20Liquidity) - As of **June 30, 2025**, the company had **$46.5 million in cash, cash equivalents, and investments**, down from **$75.1 million at December 31, 2024**[114](index=114&type=chunk) - The company believes its **capital resources are sufficient for at least 12 months** but anticipates needing **additional capital due to significant R&D and SG&A expenses**[114](index=114&type=chunk)[115](index=115&type=chunk) [Cash Flows](index=30&type=section&id=Cash%20Flows) Cash Flows (Six Months Ended June 30, in thousands): | Activity | 2025 | 2024 | | :-------------------------------- | :----- | :----- | | Net cash used in operating activities | $(14,960) | $(14,867) | | Net cash provided by investing activities | $23,713 | $6,826 | | Net cash used in financing activities | $(14,084) | $(15) | | Net decrease in cash, cash equivalents, and restricted cash | $(5,331) | $(8,056) | - **Net cash used in operating activities increased slightly by $0.1 million** in **H1 2025** compared to **H1 2024**, primarily due to **continued development costs for SCY-247 and ibrexafungerp**[118](index=118&type=chunk) - **Net cash provided by investing activities significantly increased to $23.7 million** in **H1 2025** from **$6.8 million in H1 2024**, driven by **maturities of investments**[121](index=121&type=chunk) - **Net cash used in financing activities increased substantially to $14.1 million** in **H1 2025**, primarily due to the **$14.0 million repayment of convertible debt**[122](index=122&type=chunk) [Future Funding Requirements](index=30&type=section&id=Future%20Funding%20Requirements) - The company anticipates **substantial additional funding will be required** for **ongoing operations**, particularly for **research, development, and clinical trials of product candidates**[123](index=123&type=chunk) - Future capital requirements depend on factors such as the success of the **GSK License Agreement**, clinical development progress of SCY-247 and ibrexafungerp, regulatory approvals, intellectual property, and strategic alliances[125](index=125&type=chunk)[128](index=128&type=chunk) - Funding strategies include **equity offerings (potentially dilutive)**, **debt financings (with covenants)**, **non-dilutive third-party funding**, and **strategic alliances/licensing arrangements (potentially relinquishing rights)**[125](index=125&type=chunk) [Significant Estimates and Judgments](index=32&type=section&id=Significant%20Estimates%20and%20Judgments) - The **preparation of financial statements requires management to make estimates and assumptions** affecting **reported asset/liability amounts and revenue/expense disclosures**, which are **evaluated on an ongoing basis**[126](index=126&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that quantitative and qualitative disclosures about market risk are not applicable to smaller reporting companies - This item is **not applicable to smaller reporting companies**[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms management's evaluation of the effectiveness of the company's disclosure controls and procedures, concluding they were effective as of June 30, 2025. It also states that there have been no material changes in internal control over financial reporting during the quarter [Management's Evaluation of our Disclosure Controls and Procedures](index=33&type=section&id=Management's%20Evaluation%20of%20our%20Disclosure%20Controls%20and%20Procedures) - As of **June 30, 2025**, **management, with the participation of the principal executive and financial officers, concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level**[131](index=131&type=chunk) [Changes in Internal Control Over Financial Reporting](index=33&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - During the **three months ended June 30, 2025**, there were **no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting**[132](index=132&type=chunk) [PART II. OTHER INFORMATION](index=33&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) This section provides an update on the legal proceedings, including a securities class action and shareholder derivative complaints, both alleging misstatements regarding cross-contamination risks and internal controls. The company intends to vigorously defend these litigations - A **securities class action**, filed **November 7, 2023**, alleges misleading statements about ibrexafungerp manufacturing and internal controls. The **court granted the company's motion to dismiss with leave to amend on July 30, 2025**[134](index=134&type=chunk) - **Shareholder derivative complaints**, filed **May and June 2024**, assert similar claims against directors and officers, are consolidated, and currently stayed. The company disagrees with the allegations and intends to defend vigorously[135](index=135&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section highlights the risk of the company's common stock being delisted from the Nasdaq Global Market due to non-compliance with the minimum $1.00 bid price requirement. The company received a deficiency notice and has until December 17, 2025, to regain compliance - The company received a **Nasdaq notification** on **June 20, 2025**, for failing to maintain a **minimum closing bid price of $1.00 per share for 30 consecutive business days**[138](index=138&type=chunk) - The **compliance date to regain the $1.00 minimum bid price is December 17, 2025**. Failure to comply could lead to **delisting or transfer to the Nasdaq Capital Market**, potentially requiring a **reverse stock split**[139](index=139&type=chunk)[140](index=140&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including organizational documents, certifications, and XBRL data files - Exhibits include **Amended and Restated Certificate of Incorporation**, **By-Laws**, **Certifications of CEO and CFO (31.1*, 31.2*, 32.1**), **Inline XBRL Instance Document**, and **Cover Page Interactive Data File**[143](index=143&type=chunk) [Signatures](index=37&type=section&id=Signatures) This section contains the official signatures of the Chief Executive Officer and Chief Financial Officer, certifying the report on behalf of SCYNEXIS, Inc - The report is signed by **David Angulo, M.D., Chief Executive Officer**, and **Ivor Macleod, Chief Financial Officer**, on **August 12, 2025**[148](index=148&type=chunk)

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].

Core Insights - SCYNEXIS, Inc. reported its financial results for Q1 2025, highlighting significant developments in its clinical programs and financial performance [1][6]. Clinical Developments - The FDA lifted the clinical hold on ibrexafungerp, allowing the Phase 3 MARIO study to resume, which evaluates ibrexafungerp for invasive candidiasis treatment [4][7]. - SCYNEXIS is addressing a disagreement with GSK regarding the termination of the MARIO study, asserting that GSK does not have the right to unilaterally terminate it under their license agreement [4][7]. - The company is also advancing its second-generation fungicide candidate, SCY-247, with Phase 1 study results expected in Q3 2025 [2][8]. Financial Performance - For Q1 2025, SCYNEXIS reported license agreement revenue of $0.3 million, a decrease from $1.4 million in Q1 2024 [9]. - Research and development expenses decreased to $5.1 million in Q1 2025 from $7.2 million in Q1 2024, a reduction of 29% [10]. - The net loss for Q1 2025 was $5.4 million, or $(0.11) per share, compared to a net income of $0.4 million, or $0.01 per share, in Q1 2024 [13]. Cash Position - As of March 31, 2025, SCYNEXIS had cash, cash equivalents, and investments totaling $53.8 million, down from $75.1 million at the end of 2024 [14][20]. - The company projects a cash runway into Q3 2026 based on its current operating plan [14][17]. Market Context - SCYNEXIS is focused on developing antifungal solutions to combat the rising threat of drug-resistant fungal infections, particularly invasive candidiasis, which has limited treatment options [3][15]. - The company’s first antifungal agent, ibrexafungerp, is already approved in the U.S. for vulvovaginal candidiasis and is in late-stage development for other indications [15][16].

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].

Financial Performance - For the year ended December 31, 2024, total revenue was $3.7 million, a decrease of 97.3% from $140.1 million in 2023, primarily due to a significant drop in license agreement revenue[315]. - The net loss for the year ended December 31, 2024, was $21.3 million, compared to a net income of $67.0 million in 2023, representing a decline of $88.3 million or 131.8%[315]. - 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%[317]. - Selling, general and administrative expenses decreased to $14.5 million in 2024 from $20.9 million in 2023, a decrease of $6.5 million or 30.9%[319]. - The company recognized $4.3 million in interest income for the year ended December 31, 2024, an increase from $4.0 million in 2023[322]. - The fair value adjustment for warrant liabilities resulted in a gain of $13.8 million in 2024, compared to a loss of $3.2 million in 2023[324]. - Stock-based compensation expense for the year ended December 31, 2024, totaled $3.346 million, an increase from $2.624 million in 2023[351]. Cash Flow and Capital Requirements - As of December 31, 2024, cash, cash equivalents, and investments totaled approximately $75.1 million, down from $98.0 million as of December 31, 2023[326]. - Net cash used in operating activities was $24.0 million for the year ended December 31, 2024, primarily due to the net loss adjusted for non-cash charges[330]. - The company received a $10.0 million development milestone under the GSK License Agreement in 2024, compared to $115.0 million received in the prior period[329]. - The company anticipates continued losses for several years, driven by significant research and development and administrative expenses, indicating a potential need for additional capital[327]. - The company anticipates substantial additional funding will be needed for ongoing research, development, and clinical trials of product candidates[334]. - Future capital requirements will depend on achieving development, regulatory, and commercial milestones under the GSK License Agreement[336]. - The company expects to finance cash needs through equity offerings, debt financings, or non-dilutive third-party funding, which may dilute existing stockholder interests[338]. Research and Development - Research and development expenses are expected to remain significant as SCYNEXIS continues to develop ibrexafungerp and SCY-247, with no reasonable estimate of the costs required to complete their development[309][310]. - The FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to ibrexafungerp for multiple indications, which may provide additional market exclusivity[289]. - SCY-247, a second-generation antifungal compound, is currently in clinical development with a Phase 1 study initiated in Q4 2024[288][299]. - The company recalled BREXAFEMME due to potential cross-contamination risks and is working with the FDA to resolve the clinical hold on ibrexafungerp studies[296][298]. - SCYNEXIS anticipates restarting the Phase 3 MARIO study for ibrexafungerp in Q2 2025 after addressing the FDA's concerns[298]. - The company has entered into new manufacturing agreements to produce new batches of ibrexafungerp to lift the clinical hold[298]. Legal and Regulatory Matters - A securities class action lawsuit was filed against SCYNEXIS alleging misleading statements regarding the manufacturing process of ibrexafungerp[303]. Market and Financial Position - As of December 31, 2024, SCYNEXIS reported cash, cash equivalents, and investments totaling $75.1 million, with an accumulated deficit of $376.5 million[304][305]. - The company recorded a net unfavorable change in operating assets and liabilities of $30.6 million, primarily due to a $31.5 million increase in operating assets[331]. - The weighted average expected volatility for employee stock options increased to 80.94% in 2024 from 74.77% in 2023[350].

Core Insights - SCYNEXIS, Inc. has completed the dosing of the first cohort in its Phase 1 trial for SCY-247, a second-generation antifungal aimed at treating severe invasive fungal infections [1][2] - The company emphasizes the urgent need for new antifungal therapies due to rising drug resistance and high mortality rates associated with invasive fungal diseases [2] Company Overview - SCYNEXIS is a biotechnology firm focused on developing innovative medicines to combat difficult-to-treat infections, particularly those that are increasingly drug-resistant [4] - The company’s antifungal platform, known as "fungerps," includes Ibrexafungerp, which has received FDA approval for vulvovaginal candidiasis and is under investigation for invasive fungal infections [4] Product Development - SCY-247 is a novel antifungal compound from a new class of glucan synthase inhibitors, showing broad-spectrum antifungal activity against multidrug-resistant pathogens [3] - The Phase 1 trial for SCY-247 involves approximately 100 healthy subjects, focusing on safety, tolerability, and pharmacokinetics [2][3] - SCYNEXIS anticipates potential FDA designations for SCY-247, including Qualified Infectious Disease Product (QIDP) and Fast Track status for both oral and IV formulations [3]