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 September 30, 2023 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. Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-acce ...

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, 2023 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 incorporation or organizat ...

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 March 31, 2023 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 incorporation or organiza ...

Part I [Business](index=5&type=section&id=Item%201.%20Business) SCYNEXIS, Inc. develops innovative medicines for drug-resistant infections, strategically out-licensing BREXAFEMME to GSK to focus on hospital-based fungal indications [Overview and GSK License Agreement](index=5&type=section&id=Item%201.%20Business%20-%20Overview%20and%20GSK%20License%20Agreement) SCYNEXIS entered a significant license agreement with GSK for ibrexafungerp, including a **$90 million** upfront payment and potential milestones, enabling a strategic shift and debt repayment - On March 30, 2023, SCYNEXIS entered into an exclusive license agreement with GSK for the development, manufacture, and commercialization of ibrexafungerp (including BREXAFEMME) in all countries except Greater China and other specified territories[22](index=22&type=chunk) GSK License Agreement Financial Terms | Milestone Type | Potential Amount | Details | | :--- | :--- | :--- | | **Upfront Payment** | $90 million | Payable upon closing of the agreement | | **Regulatory Approval Milestones** | Up to $70 million | Success-based payments for regulatory approvals | | **Development Milestones** | Up to $75.5 million | For achieving milestones in the ongoing MARIO Study | | **Commercial Milestones** | Up to $115 million | Based on the first commercial sale in invasive candidiasis (U.S./EU) | | **Sales Milestones** | Up to $242.5 million | Tiered payments based on achieving annual net sales thresholds up to $1 billion | | **Royalties** | Mid-single digit to mid-teen range | Based on cumulative annual net sales | - In connection with the GSK agreement, SCYNEXIS will repay its loan from Hercules Capital and SVB, totaling approximately **$37 million** (including principal, interest, and fees), upon receipt of the **$90 million** upfront payment from GSK[25](index=25&type=chunk) [Clinical Programs and Pipeline](index=7&type=section&id=Item%201.%20Business%20-%20Clinical%20Programs%20and%20Pipeline) The company is advancing a broad clinical program for ibrexafungerp in hospital and community settings, with key Phase 3 data expected in H1 2024 to support a 2024 NDA submission Ibrexafungerp Clinical Program Status and Timelines | Indication | Study Name | Phase | Key Milestone/Data Expected | | :--- | :--- | :--- | :--- | | Invasive Candidiasis (IC) | MARIO | 3 | Topline data H1 2024 | | Refractory Invasive Fungal Infections (rIFI) | FURI | 3 | Topline data H1 2024 | | Candida auris Infections | CARES | 3 | Topline data H1 2024 | | Invasive Aspergillosis (Combination) | SCYNERGIA | 2 | Topline data H1 2023 | | Complicated VVC (Fluconazole Failures) | VANQUISH | 3b | Topline data H1 2024 | - Data from the MARIO, FURI, and CARES studies are intended to support an NDA submission in 2024 for a hospital-based indication, with potential approval later that year[32](index=32&type=chunk) - A second-generation fungerp, SCY-247, is under preclinical development with the support of a **$3.0 million** NIH grant to study its potential against Candida auris[40](index=40&type=chunk) [Market Opportunity and Competition](index=10&type=section&id=Item%201.%20Business%20-%20Market%20Opportunity%20and%20Competition) SCYNEXIS targets significant market opportunities in VVC and invasive fungal infections, addressing unmet needs due to resistance and lack of oral options, while facing competition from established pharmaceutical companies - The U.S. market for VVC accounts for over **17 million** prescriptions annually, almost entirely from the azole drug class prior to BREXAFEMME's launch[48](index=48&type=chunk) - There is a significant unmet need for new antifungal treatments for invasive candidiasis due to resistance to existing therapies and the lack of oral step-down options for many patients[51](index=51&type=chunk) - Key competitors include large pharmaceutical companies such as Merck, Pfizer, Astellas, and Gilead with established antifungal products; newer competitors include Mycovia (Vivjoa) and Cidara Therapeutics (Rezzayo)[54](index=54&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk) [Collaborations and Licensing Agreements](index=13&type=section&id=Item%201.%20Business%20-%20Collaborations%20and%20Licensing%20Agreements) The company's strategy relies heavily on collaborations, including the significant March 2023 GSK agreement, an exclusive license with Hansoh for Greater China, and an agreement with R-Pharm, while Merck is eligible for royalties from the foundational IP acquisition - Entered into a license agreement with GSK in March 2023 for exclusive rights to ibrexafungerp in all countries except Greater China and other specified territories[65](index=65&type=chunk) - In February 2021, granted Hansoh an exclusive license for ibrexafungerp in the Greater China region, receiving a **$10.0 million** upfront payment and eligibility for up to **$112.0 million** in milestones plus royalties[74](index=74&type=chunk) - Acquired all human health rights to ibrexafungerp from Merck in 2013; Merck is eligible to receive tiered mid- to high-single-digit royalties on worldwide net sales[70](index=70&type=chunk)[71](index=71&type=chunk) [Intellectual Property](index=20&type=section&id=Item%201.%20Business%20-%20Intellectual%20Property) SCYNEXIS maintains a strong intellectual property portfolio, with over 10 issued U.S. patents and 125 non-U.S. patents, protecting ibrexafungerp until at least 2035 through composition of matter and use patents - As of March 1, 2023, the company owns over **10** issued U.S. patents and over **125** issued non-U.S. patents related to its compounds and their uses[118](index=118&type=chunk) - The primary composition of matter patent for ibrexafungerp (U.S. Patent No. 8,188,085) is expected to be extended to **2035**; patents covering the citrate salt expire in **2035**, and use patents expire in **2038**[119](index=119&type=chunk) [Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its financial condition, product development, and heavy reliance on third parties, including a history of losses and the critical need for the GSK license agreement to close - The company has a history of unprofitability, with a net loss of **$62.8 million** for the year ended December 31, 2022, and an accumulated deficit of approximately **$422.3 million**, raising substantial doubt about its ability to continue as a going concern[129](index=129&type=chunk) - The consummation of the license agreement with GSK is subject to closing conditions, including HSR waiting period expiration; failure to close would materially and adversely affect prospects for generating revenue from ibrexafungerp[126](index=126&type=chunk)[127](index=127&type=chunk) - The company is dependent on third-party collaborations with GSK, Hansoh, and R-Pharm for commercialization revenue and relies on third-party CROs and manufacturers for development and supply, creating risks if these partners do not perform[207](index=207&type=chunk)[208](index=208&type=chunk)[210](index=210&type=chunk) - The business is subject to extensive and evolving data privacy and security laws, such as GDPR and CCPA, and a failure to comply could lead to significant fines, litigation, and reputational harm[245](index=245&type=chunk)[247](index=247&type=chunk)[249](index=249&type=chunk) [Properties](index=46&type=section&id=Item%202.%20Properties) SCYNEXIS leases approximately **19,275 square feet** of office space for its corporate headquarters in Jersey City, New Jersey, under a lease agreement extending until July 2029 - The company leases approximately **19,275 square feet** of office space in Jersey City, New Jersey, under a long-term lease agreement that runs until July 2029[277](index=277&type=chunk) [Legal Proceedings](index=46&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, SCYNEXIS, Inc. is not a party to any material legal proceedings that would require disclosure - The company is not party to any legal proceedings requiring disclosure under this item[278](index=278&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=48&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq Global Market under "SCYX", with no history or intention of paying cash dividends, as funds are retained for operations and growth - Common stock trades on the Nasdaq Global Market under the symbol "SCYX"[281](index=281&type=chunk) - The company has never declared or paid cash dividends and does not intend to for the foreseeable future, with future earnings to be retained for operations[282](index=282&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=49&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion highlights the strategic shift to hospital-based indications, a **$62.8 million** net loss in 2022 driven by increased SG&A and R&D, and critical liquidity concerns necessitating the GSK deal's closing Results of Operations (in thousands) | | 2022 | 2021 | | :--- | :--- | :--- | | **Total revenue** | $5,091 | $13,163 | | Product revenue, net | $4,988 | $1,113 | | License agreement revenue | $103 | $12,050 | | **Total operating expenses** | $90,848 | $74,001 | | Research and development | $27,259 | $23,773 | | Selling, general and administrative | $62,961 | $49,916 | | **Loss from operations** | ($85,757) | ($60,838) | | **Net Loss** | ($62,809) | ($32,866) | | **Net loss per share** | ($1.47) | ($1.25) | - The decrease in total revenue in 2022 was primarily due to the recognition of a **$12.1 million** upfront payment from the Hansoh license agreement in 2021, which was not repeated in 2022[315](index=315&type=chunk) - The increase in operating expenses was driven by a **$13.0 million** rise in SG&A costs to support the commercialization of BREXAFEMME and a **$3.5 million** increase in R&D expenses for clinical studies like MARIO[317](index=317&type=chunk)[319](index=319&type=chunk) - The company's financial condition, with significant losses and negative cash flows, raises substantial doubt about its ability to continue as a going concern; the company will need additional capital to fund operations[337](index=337&type=chunk) [Consolidated Financial Statements and Supplementary Data](index=61&type=section&id=Item%208.%20Consolidated%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for SCYNEXIS, Inc., highlighting a **$62.8 million** net loss in 2022 and an auditor's "Going Concern" opinion, with notes detailing the subsequent GSK license agreement and debt repayment [Report of Independent Registered Public Accounting Firm](index=62&type=section&id=Item%208.%20-%20Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Deloitte & Touche LLP's report states fair presentation but includes a "Going Concern" paragraph due to significant losses and negative cash flows, also identifying Gross-to-net (GTN) rebate accruals as a Critical Audit Matter - The auditor's report includes a "Going Concern" paragraph, citing significant losses and negative cash flows from operations, which raises substantial doubt about the company's ability to continue as a going concern[366](index=366&type=chunk) - The audit identified Gross-to-net (GTN) rebate accruals as a Critical Audit Matter, highlighting the complexity and subjective judgment required in estimating these adjustments to revenue[371](index=371&type=chunk)[373](index=373&type=chunk) [Financial Statements](index=64&type=section&id=Item%208.%20-%20Financial%20Statements) The consolidated financial statements for 2022 show a significant deterioration, with total assets decreasing to **$87.8 million**, total liabilities increasing to **$84.6 million**, stockholders' equity plummeting to **$3.2 million**, and a net loss of **$62.8 million** Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Total Current Assets** | $79,061 | $109,377 | | Cash and cash equivalents | $45,814 | $104,484 | | **Total Assets** | $87,810 | $119,837 | | **Total Liabilities** | $84,577 | $78,579 | | **Total Stockholders' Equity** | $3,233 | $41,258 | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | **Total Revenue** | $5,091 | $13,163 | | **Loss from Operations** | ($85,757) | ($60,838) | | **Net Loss** | ($62,809) | ($32,866) | Consolidated Statement of Cash Flows Data (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($79,883) | ($54,560) | | **Net cash provided by financing activities** | $48,602 | $67,120 | | **Net (decrease) increase in cash** | ($58,670) | $11,388 | [Subsequent Events (Note 16)](index=92&type=section&id=Item%208.%20-%20Subsequent%20Events%20%28Note%2016%29) Subsequent to year-end, on March 30, 2023, SCYNEXIS entered a pivotal license agreement with GSK for ibrexafungerp, including a **$90 million** upfront payment and significant milestones, concurrently agreeing to repay approximately **$37 million** in outstanding debt - On March 30, 2023, the company entered into a license agreement with GSK, which includes a **$90 million** upfront payment and potential for significant future milestones and royalties[527](index=527&type=chunk)[528](index=528&type=chunk) - In connection with the GSK deal, the company agreed to repay its outstanding loan with Hercules and SVB; the total repayment amount is approximately **$35.4 million** plus a prepayment fee of **$262,500** and a final payment of **$1,382,500**[535](index=535&type=chunk) [Controls and Procedures](index=94&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2022, with no material changes reported during the fourth quarter - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[540](index=540&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[541](index=541&type=chunk) Part III [Directors, Executive Compensation, Security Ownership, and Accountant Fees](index=95&type=section&id=Items%2010-14) Information for Items 10 through 14, covering corporate governance, executive compensation, security ownership, and principal accountant fees, is incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - The information required by Items 10, 11, 12, 13, and 14 is incorporated by reference from the company's Proxy Statement to be filed for the 2023 Annual Meeting of Stockholders[547](index=547&type=chunk)[548](index=548&type=chunk)[549](index=549&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=96&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements from Item 8 and provides a detailed index of all exhibits filed with the report, noting the omission of financial statement schedules as not applicable - This section contains the list of financial statements from Item 8 and an index of all exhibits filed with the Form 10-K[550](index=550&type=chunk)[552](index=552&type=chunk)

Financial Data and Key Metrics Changes - SCYNEXIS reported net product revenues for BREXAFEMME in Q3 2022 increased approximately 23% to $1.6 million compared to $1.3 million in Q2 2022 [30] - Research and development expenses rose to $6.4 million in Q3 2022 from $4.4 million in the same period in 2021, primarily due to increased clinical development expenses [31] - Selling, general and administrative expenses increased to $16.7 million in Q3 2022 from $15.4 million in Q3 2021, driven by costs associated with BREXAFEMME commercialization [32] - Total cash, cash equivalents, and short-term investments at the end of Q3 2022 totaled $96.1 million, down from $100.1 million at the same time in 2021 [34] Business Line Data and Key Metrics Changes - The number of healthcare providers prescribing BREXAFEMME increased by 11% quarter-over-quarter, with almost 2,500 prescribers in Q3 2022 [15] - BREXAFEMME prescriptions grew to nearly 5,800 in Q3 2022, representing a 30% increase over Q2 2022 [16] Market Data and Key Metrics Changes - SCYNEXIS secured BREXAFEMME coverage for 130 million commercially insured lives, representing 70% of the commercial universe after signing a contract with a major national pharmacy benefit manager [17] Company Strategy and Development Direction - The company is refocusing resources on the clinical development of ibrexafungerp for severe hospital-based indications, anticipating higher long-term returns [11] - SCYNEXIS is actively pursuing commercialization partners for BREXAFEMME in the U.S. and ibrexafungerp outside the U.S. [10] - The supplemental NDA filing for recurrent vulvovaginal candidiasis is on track with a PDUFA decision date of November 30, 2022 [13] Management's Comments on Operating Environment and Future Outlook - Management emphasized the growing threat of serious fungal infections and the potential of ibrexafungerp to address these needs, positioning the company favorably in the market [20] - The company expects to extend its cash runway into the second quarter of 2024, supporting its hospital programs and additional regulatory filings [14][39] Other Important Information - The company is preparing for a potential approval of BREXAFEMME for recurrent VVC, which would make it the first therapy approved in the U.S. for both treatment and prevention of recurrent VVC [13] - The anticipated hospital program could generate $300 million to $400 million in annual net sales in the U.S. alone [38] Q&A Session Summary Question: When will SCYNEXIS see an out-licensing or partner for BREXAFEMME? - Management is actively pursuing potential partners and expects interest to grow following the anticipated approval of recurrent VVC [44] Question: How will SCYNEXIS succeed in the hospital setting? - Management believes ibrexafungerp's unique product profile will create interest, supported by a focused development program addressing significant unmet needs [46][48] Question: Will fourth quarter sales be down compared to the third quarter? - Management indicated potential disruption in sales due to the cessation of in-person promotion but noted ongoing patient access to the product [49] Question: Does the inclusion of ibrexafungerp on the WHO's priority pathogen list improve funding opportunities? - Management sees the WHO recognition as a positive signal that could attract funding and partnerships, emphasizing the critical need for innovation in fungal infections [53][55] Question: What is the timeline for the MARIO study? - Enrollment is expected to be completed by the end of next year, with data reporting anticipated in early 2024 [57] Question: What is the timeline for the SCYNERGIA study? - Data from the SCYNERGIA study is expected to be reported in the first half of next year [72]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q Commission File Number 001-36365 (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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period to SCYNEXIS, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2181648 (State or other jurisdiction of incorp ...

SCYNEXIS, Inc. (NASDAQ:SCYX) Q2 2022 Results Conference Call August 15, 2022 8:30 AM ET Company Participants Debbie Etchison - Communications and IR Dr. Marco Taglietti - President and CEO Christine Coyne - Chief Commercial Officer Dr. David Angulo - Chief Medical Officer Larry Hoffman - Interim CFO Conference Call Participants Carvey Leung - Cantor Fitzgerald Farhana Sakloth - Ladenburg Thalmann Oren Livnat - H.C. Wainwright Kumar Raja - Brookline Capital Markets Steve Brozak - WBB Securities Operator Ladi ...

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 MARCH 31, 2022 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) Delaware 56-2181648 (State or other jurisdiction of incor ...

SCYNEXIS, Inc. (NASDAQ:SCYX) Q1 2022 Earnings Conference Call May 12, 2022 8:30 AM ET Company Participants Marco Taglietti – President and Chief Executive Officer Christine Coyne – Chief Commercial Officer Dr. David Angulo – Chief Medical Officer Lawrence Hoffman – Interim Chief Financial Officer Debbie Etchison – Executive Director, Communications Conference Call Participants Michael Higgins – Ladenburg Thalmann Wayne Buchan – Cantor Fitzgerald Oren Livnat – H.C. Wainwright Operator Greetings and welcome t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2021 OR ☐ 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 ...