SCYX 10-Q
Scynexis Inc (SCYX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
OR
For the transition period to
Commission File Number
(Exact name of registrant as specified in its charter)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
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Name of Each Exchange on Which Registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of November 1, 2025, there were
SCYNEXIS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2025
TABLE OF CONTENTS
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Item 1. |
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1 |
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Unaudited Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024 |
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2 |
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3 |
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Notes to the Condensed Consolidated Financial Statements (unaudited) |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 4. |
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Item 1. |
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Item 6. |
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
SCYNEXIS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
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September 30, 2025 |
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December 31, 2024 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term investments |
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Prepaid expenses and other current assets |
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License agreement receivable |
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License agreement contract asset |
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Restricted cash |
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Total current assets |
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Investments |
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Deferred offering costs |
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Restricted cash |
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Operating lease right-of-use asset |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Deferred revenue, current portion |
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Operating lease liability, current portion |
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Convertible debt |
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Total current liabilities |
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Deferred revenue |
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Warrant liability |
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Operating lease liability |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of the financial statements.
1
SCYNEXIS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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License agreement revenue |
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$ |
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$ |
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$ |
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$ |
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Operating expenses: |
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Research and development |
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Selling, general and administrative |
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Total operating expenses |
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Loss from operations |
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Other (income) expense: |
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Amortization of debt issuance costs and discount |
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Interest income |
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Interest expense |
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Warrant liability fair value adjustment |
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Derivative liability fair value adjustment |
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Total other expense (income) |
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Loss before taxes |
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Income tax (benefit) expense |
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Net loss |
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$ |
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$ |
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$ |
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$ |
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Net loss per share – basic and diluted |
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$ |
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$ |
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$ |
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$ |
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Weighted average common shares outstanding – basic and diluted |
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The accompanying notes are an integral part of the financial statements.
2
SCYNEXIS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
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Nine Months Ended September 30, |
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2025 |
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2024 |
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Cash flows from operating activities: |
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Net loss |
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$ |
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$ |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation expense |
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Accretion of investments discount |
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Amortization of debt issuance costs and discount |
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Change in fair value of warrant liability |
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Change in fair value of derivative liability |
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Noncash operating lease expense for right-of-use asset |
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Changes in operating assets and liabilities: |
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Prepaid expenses, other assets, deferred costs, and other |
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License agreement receivable |
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License agreement contract asset |
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Accounts payable |
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Accrued expenses |
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Deferred revenue |
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Other liabilities |
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Net cash used in operating activities |
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Cash flows from investing activities: |
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Purchase of investments |
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Maturity of investments |
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Net cash provided by investing activities |
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Cash flows from financing activities: |
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Proceeds from common stock issued |
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Payment of convertible debt |
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Payment of deferred offering costs |
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Proceeds from employee stock purchase plan issuances |
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Net cash (used in) provided by financing activities |
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Net decrease in cash, cash equivalents, and restricted cash |
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Cash, cash equivalents, and restricted cash at beginning of period |
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Cash, cash equivalents, and restricted cash at end of period |
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$ |
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$ |
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Supplemental cash flow information: |
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Cash paid for interest |
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$ |
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$ |
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Cash received for interest |
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$ |
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$ |
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Noncash financing and investing activities: |
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Deferred offering costs reclassified to additional paid-in capital |
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$ |
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$ |
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The accompanying notes are an integral part of the financial statements.
3
SCYNEXIS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Description of Business and Basis of Preparation
Organization
SCYNEXIS, Inc. ("SCYNEXIS" or the “Company”) is a Delaware corporation formed on November 4, 1999. SCYNEXIS is a biotechnology company, headquartered in Jersey City, New Jersey, and is pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections. The Company is developing its proprietary class of triterpenoid antifungal compounds (“fungerps") as broad-spectrum, systemic antifungal agents for multiple fungal indications. Ibrexafungerp is the first representative of this novel class of antifungals and was approved by the U.S. Food and Drug Administration (“FDA”) as BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis ("VVC") and for the reduction in the incidence of recurrent vulvovaginal candidiasis ("rVVC") in 2021 and 2022, respectively.
The Company licensed the rights for ibrexafungerp to GlaxoSmithKline Intellectual Property (No. 3) Limited (“GSK”) via an exclusive license agreement dated March 30, 2023, which was subsequently amended by the binding memorandums of understanding dated December 26, 2023 and October 14, 2025 (collectively, the “GSK License Agreement”). See Notes 10 and 12 for further details.
A second generation fungerp SCY-247 is currently being evaluated in clinical trials and additional compounds from the Company's proprietary fungerp platform, targeted to address significant unmet needs, are in earlier stages of development. The Company recently completed the single and multiple ascending dose portions of the ongoing Phase 1 study of oral SCY-247. Following the positive results of the oral formulation, the Company intends to initiate a Phase 1 study of the intravenous formulation in the first quarter of 2026. A clinical proof-of-concept Phase 2 study in patients with invasive candidiasis is also anticipated in 2026. Subsequent stages of development are anticipated to include studies adequate to support an invasive candidiasis treatment indication, as well as evaluating SCY-247 for the prevention of invasive fungal diseases in patients at high risk.
The Company had an accumulated deficit of $
The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. Intercompany balances and transactions are eliminated in consolidation.
Nasdaq Minimum Bid Price Notification
On June 20, 2025, the Company received a letter from the Listing Qualifications Department staff (the "Staff") of the Nasdaq notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company's common stock was below the $
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days from June 20, 2025, or until December 17, 2025 (the "Compliance Date"), to regain compliance with the minimum bid price rule. Thereafter, if such a company does not regain compliance with the bid price requirement, a second 180-day compliance period may be available. If, at any time before the Compliance Date, the closing bid price of the Company's common stock is at least $
4
minimum of 10 consecutive business days, the Staff will provide the Company written confirmation of compliance with the minimum bid price rule and the matter will be closed.
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates and judgments include: determination of the fair value of stock-based compensation grants; the estimate of services and effort expended by third-party research and development service providers used to recognize research and development expense; and the estimates and assumptions utilized in measuring the fair value of the warrant liability each reporting period.
Unaudited Condensed Consolidated Financial Information
The accompanying unaudited condensed consolidated financial statements and notes have been prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”), as contained in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (the “Codification” or “ASC”) for interim financial information. In the opinion of management, the interim financial information includes all adjustments of a normal recurring nature necessary for a fair presentation of the results of operations, financial position, and cash flows. The results of operations for the three and nine months ended September 30, 2025, are not necessarily indicative of the results for the full year or the results for any future periods. These unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes set forth in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 12, 2025.
2. Summary of Significant Accounting Policies
The accompanying unaudited condensed consolidated financial statements and notes follow the same significant accounting policies as those described in the notes to the audited consolidated financial statements of the Company for the year ended December 31, 2024, except as described below.
Basic and Diluted Net Loss per Share of Common Stock
The Company calculates net loss per common share in accordance with ASC 260, Earnings Per Share. Basic net loss per common share for the three and nine months ended September 30, 2025 and 2024 was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Per ASC 260, Earnings Per Share, the weighted average number of common shares outstanding utilized for determining the basic net loss per common share for the three and nine months ended September 30, 2025 and 2024 includes the outstanding prefunded warrants to purchase
The following potentially dilutive shares of common stock and outstanding restricted stock units that contain certain performance contingencies have not been included in the computation of diluted net loss per share for the three and nine months ended September 30, 2025 and 2024, as the result would be anti-dilutive or the performance contingencies have not been met:
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2025 |
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2024 |
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2024 |
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Outstanding stock options |
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Outstanding restricted stock units |
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Warrants to purchase common stock associated with April 2022 public offering |
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Warrants to purchase common stock associated with loan agreement |
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Common stock associated with March 2019 Notes |
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Warrants to purchase common stock associated with Danforth |
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Total |
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Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures, which introduced new guidance on disclosures for reportable segments and significant segment expenses,
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including for entities with a reportable segment. This guidance is effective for the Company for annual reporting periods beginning January 1, 2024 and interim periods beginning January 1, 2025. The Company
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures, which introduced new guidance on disclosures for income taxes, including enhancements to the rate reconciliation and income taxes paid disclosures. This guidance is effective for the Company for annual reporting periods beginning January 1, 2025. ASU 2023-09 did
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), Disaggregation of Income Statement Expenses, which introduced new guidance on disclosures for specified costs and expenses. This guidance is effective for the Company for annual reporting periods beginning January 1, 2027. The Company is currently evaluating the impact ASU 2024-03 will have on its consolidated financial statements.
Recently Enacted Income Tax Legislation
The One Big Beautiful Bill Act (“OBBBA”) was enacted on July 4, 2025, and the Company continues to evaluate the impact on its financial position. The OBBBA is not currently expected to materially impact the Company’s effective tax rate or cash flows in the current fiscal year.
3. Investments
The following table summarizes the investments at September 30, 2025 (in thousands):
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Amortized |
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Unrealized |
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Unrealized |
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Fair Value |
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As of September 30, 2025 |
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Maturities < 1 Year |
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Corporate bonds |
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$ |
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$ |
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$ |
( |
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$ |
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Total short-term investments |
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$ |
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$ |
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$ |
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$ |
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As of December 31, 2024 |
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Maturities < 1 Year |
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Corporate bonds |
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$ |
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$ |
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$ |
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$ |
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Agency bonds |
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Total short-term investments |
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$ |
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$ |
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$ |
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$ |
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Maturities > 1 Year |
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Corporate bonds |
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$ |
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$ |
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$ |
( |
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$ |
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Total investments |
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$ |
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$ |
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$ |
( |
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$ |
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The Company carries investments at amortized cost. As of September 30, 2025 and December 31, 2024, the fair value of the corporate and agency bonds totals $
4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
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September 30, 2025 |
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December 31, 2024 |
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Prepaid research and development services |
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$ |
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$ |
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Prepaid insurance |
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Other prepaid expenses |
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Other current assets |
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Total prepaid expenses and other current assets |
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$ |
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$ |
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6
5. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
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September 30, 2025 |
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December 31, 2024 |
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Accrued research and development expenses |
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$ |
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$ |
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Accrued employee bonus compensation |
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Other accrued expenses |
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Accrued product recall |
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Total accrued expenses |
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$ |
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$ |
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6. Contingencies and Borrowings
Legal Proceedings
On November 7, 2023, a securities class action was filed by Brian Feldman against the Company and certain of the Company's executives in the United States District Court, District of New Jersey, alleging misstatements from March 31, 2023 to September 22, 2023 regarding manufacturing controls and related risks. The court granted the Company’s motion to dismiss with leave to amend on July 30, 2025, and on August 29, 2025, the parties stipulated to dismissal and the court dismissed the case with prejudice.
On May 1, 2024 and on June 4, 2024, purported shareholder derivative complaints asserting related claims were filed in the same court and later consolidated. On October 15, 2025, the court dismissed without prejudice the related consolidated shareholder derivative action. For additional information regarding the details of the securities class action and the consolidated shareholder derivative action, see Item 1 in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 filed on August 13, 2025.
March 2019 Note Purchase Agreement
On
7. Stockholders’ Equity
Authorized, Issued, and Outstanding Common Stock
The Company’s authorized common stock has a par value of $
7
The following table summarizes common stock share activity for the three and nine months ended September 30, 2025 and 2024 (dollars in thousands):
|
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Three Months Ended September 30, 2025 |
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Shares of |
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Common |
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Additional |
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Accumulated |
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Total |
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|||||
Balance, June 30, 2025 |
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$ |
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$ |
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|
$ |
( |
) |
|
$ |
|
||||
Net loss |
|
|
— |
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|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||
Stock-based compensation expense |
|
|
— |
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|
|
|
|
|
|
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|
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||||
Common stock issued through employee stock purchase plan |
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Common stock issued, net of expenses |
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|||||
Balance, September 30, 2025 |
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$ |
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|
$ |
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$ |
( |
) |
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$ |
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Three Months Ended September 30, 2024 |
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Shares of |
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Common |
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Additional |
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Accumulated |
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Total |
|
|||||
Balance, June 30, 2024 |
|
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|
$ |
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|
$ |
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|
$ |
( |
) |
|
$ |
|
||||
Net loss |
|
|
— |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||
Stock-based compensation expense |
|
|
— |
|
|
|
|
|
|
|
|
|
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|
||||
Common stock issued through employee stock purchase plan |
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|||||
Common stock issued for vested restricted stock units |
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|||||
Balance, September 30, 2024 |
|
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|
$ |
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|
$ |
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|
$ |
( |
) |
|
$ |
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||||
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|||||
|
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Nine Months Ended September 30, 2025 |
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|||||||||||||||||
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Shares of |
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|
Common |
|
|
Additional |
|
|
Accumulated |
|
|
Total |
|
|||||
Balance, December 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Net loss |
|
|
— |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||
Stock-based compensation expense |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock issued through employee stock purchase plan |
|
|
|
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|
|
|
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|
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|
|||||
Common stock issued for vested restricted stock units |
|
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|||||
Common stock issued, net of expenses |
|
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|
|
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|
|
|
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|
|||||
Balance, September 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
|
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|
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|||||
|
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Nine Months Ended September 30, 2024 |
|
|||||||||||||||||
|
|
Shares of |
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|
Common |
|
|
Additional |
|
|
Accumulated |
|
|
Total |
|
|||||
Balance, December 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Net loss |
|
|
— |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||
Stock-based compensation expense |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Common stock issued through employee stock purchase plan |
|
|
|
|
|
|
|
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|
|||||
Common stock issued for vested restricted stock units |
|
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|
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|
|
|
|
|
|
|
|
|
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|
|||||
Balance, September 30, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
8
Shares Reserved for Future Issuance
The Company had reserved shares of common stock for future issuance as follows:
|
|
September 30, 2025 |
|
|
December 31, 2024 |
|
||
Outstanding stock options |
|
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|
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||
Outstanding restricted stock units |
|
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||
Prefunded warrants to purchase common stock associated with December 2020 public offering |
|
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|
||
Warrants to purchase common stock associated with April 2022 public offering |
|
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||
Prefunded warrants to purchase common stock associated with April 2022 public offering |
|
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||
Warrants to purchase common stock associated with loan agreement |
|
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|
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Warrant to purchase common stock associated with Danforth |
|
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|
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For possible future issuance for the conversion of the March 2019 Notes |
|
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|
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For possible future issuance under 2024 Plan (Note 8) |
|
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For possible future issuance under employee stock purchase plan |
|
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|
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|
||
For possible future issuance under 2015 Plan (Note 8) |
|
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|
||
Total common shares reserved for future issuance |
|
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|
||
Warrants Associated with the April 2022 Public Offering
The fair value of the April 2022 outstanding warrants have been determined using the Black-Scholes valuation model, and the changes in the fair value are recorded in the accompanying unaudited condensed consolidated statements of operations. The outstanding warrants associated with the April 2022 public offering meet the definition of a derivative pursuant to ASC 815, Derivatives and Hedging, and do not meet the derivative scope exception given the warrants do not qualify under the indexation guidance. As a result, the April 2022 public offering warrants were initially recognized as liabilities and measured at fair value using the Black-Scholes valuation model. For the three months ended September 30, 2025 and 2024, the Company recognized a loss of $
8. Stock-based Compensation
2024 Equity Incentive Plan
In April 2024, the Company’s board of directors adopted the 2024 Equity Incentive Plan (“2024 Plan”), which was subsequently approved by the Company’s stockholders and became effective on June 19, 2024. The 2024 Plan is the successor to the 2014 Plan. The 2014 Plan terminated on February 11, 2024 and no new grants may be made under the 2014 Plan after that date, although all outstanding awards granted under the 2014 Plan will continue to be subject to the terms and conditions as set forth in the agreements evidencing such awards and the terms of the 2014 Plan. As of September 30, 2025, there were
9
2015 Inducement Award Plan
As of September 30, 2025, there were
The activity for the Company’s 2024 Plan, 2014 Plan, and 2015 Plan, for the nine months ended September 30, 2025, is summarized as follows:
|
|
Number of |
|
|
Weighted- |
|
|
Weighted- |
|
|
Aggregate |
|
||||
Outstanding — December 31, 2024 |
|
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|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
$ |
|
|
|
|
|
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|
||||
Forfeited/Cancelled |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|||
Outstanding — September 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable — September 30, 2025 |
|
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|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested or expected to vest — September 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Restricted stock unit (“RSU”) activity under the 2024 Plan, 2014 Plan, and 2015 Plan for the nine months ended September 30, 2025, is summarized as follows:
|
|
Number of |
|
|
Weighted |
|
||
Non-vested at December 31, 2024 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
$ |
|
||
Vested |
|
|
( |
) |
|
$ |
|
|
Forfeited |
|
|
( |
) |
|
$ |
|
|
Non-vested at September 30, 2025 |
|
|
|
|
$ |
|
||
The fair value of RSUs is based on the market price of the Company’s common stock on the date of grant. RSUs generally vest
Stock-based Compensation Cost
The stock-based compensation cost that has been charged against income for stock awards was $
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
10
9. Fair Value Measurements
The carrying amounts of certain financial instruments, including cash and cash equivalents, restricted cash, investments, accounts receivable, prepaid expenses and other current assets, accounts payable, and accrued expenses approximate their respective fair values due to the short-term nature of such instruments.
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made.
|
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|
|
Fair Value Hierarchy Classification |
|
||||||||||
|
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Balance |
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Quoted |
|
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Significant |
|
|
Significant |
|
||||
September 30, 2025 |
|
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|
||||
Cash |
|
$ |
|
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$ |
|
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|
||||
Restricted cash |
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|
||||
Money market funds |
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|
||||
Total assets |
|
$ |
|
|
$ |
|
|
|
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|
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|
||||
|
|
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|
||||
Warrant liability |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
||||
Total liabilities |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
||||
|
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|
|
|
|
|
|
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|
||||
December 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash |
|
$ |
|
|
$ |
|
|
|
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|
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|
||||
Restricted cash |
|
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|
|
|
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|
||||
Money market funds |
|
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|
||||
Total assets |
|
$ |
|
|
$ |
|
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|
|
|
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|
||||
|
|
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|
|
|
|
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|
||||
Warrant liability |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
||||
Total liabilities |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
||||
The Company measures cash equivalents at fair value on a recurring basis. The fair value of cash equivalents is determined based on “Level 1” inputs, which consist of quoted prices in active markets for identical assets. As of September 30, 2025, the cash and cash equivalents of $
Level 3 financial liabilities consist of the warrant liability for which there is no current market such that the determination of fair value requires significant judgment or estimation. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate. The Company uses the Black-Scholes option valuation model to value the Level 3 warrant liability at inception and on subsequent valuation dates. This model incorporates transaction details such as the Company’s stock price, contractual terms, maturity, risk free rates, as well as volatility. The unobservable input for all of the Level 3 warrant liability includes volatility. The historical and implied volatility of the Company, using its closing common stock prices and market data, is utilized to reflect future volatility over the expected term of the warrants. At September 30, 2025 and December 31, 2024, the Level 3 volatilities utilized in the Black-Scholes model to fair value the warrant liability was
11
A reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands):
|
|
|
Warrant Liabilities |
|
|
Balance – December 31, 2024 |
|
|
$ |
|
|
Gain adjustment to fair value |
|
|
|
( |
) |
Balance – September 30, 2025 |
|
|
$ |
|
|
|
|
|
|
|
|
10. Revenue
GSK License Agreement
The Company evaluated the GSK License Agreement in accordance with ASC 606 as it includes a customer-vendor relationship as defined under ASC 606 and meets the criteria to be considered a contract. The Company assessed the terms of the GSK License Agreement and identified the following performance obligations which include: (1) the license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, in the GSK Territory, (2) the research and development activities for the MARIO study, and (3) performance obligations for the remaining research and development activities for the ongoing clinical and preclinical studies of ibrexafungerp. The Company reassessed the transaction price as of September 30, 2025, including estimated variable consideration included in the transaction price and the remaining milestones continued to be constrained.
Pursuant to the GSK License Agreement, the Company is responsible for conducting the MARIO study which resumed in April 2025 after the FDA notified the Company the clinical hold of ibrexafungerp had been lifted, triggering the Company to bill a $
The Company believes that the $
11. Segments
The Company has
The table below provides information about the Company's drug development segment and includes the reconciliation to consolidated net loss for the three and nine months ended September 30, 2025 and 2024, respectively (in thousands):
12
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Less: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clinical expense |
|
|
|
|
|
|
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|
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|
|
|
||||
Preclinical expense |
|
|
|
|
|
|
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|
||||
Chemistry, manufacturing, and controls |
|
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|
||||
Selling, general, and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Income tax (benefit) expense |
|
|
|
|
|
( |
) |
|
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|
|
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|
|||
Interest expense |
|
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|
||||
Plus: |
|
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|
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|
||||
Interest income |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other segment expense (income) (1) |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Segment net loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Reconciliation of segment net loss |
|
|
|
|
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|
|
|
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|
||||
Adjustments and reconciling items |
|
|
|
|
|
|
|
|
|
|
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|
||||
Consolidated net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
(1)
12. Subsequent Events
In October 2025, the Company and GSK entered into a binding memorandum of understanding (the "Binding 2025 MOU") and the Company agreed to promptly wind-down and terminate the MARIO study and will receive one-time payments totaling $
13
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Operating results for the three and nine months ended September 30, 2025, are not necessarily indicative of results that may occur in future interim periods or future fiscal years. Some of the statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are forward-looking statements. These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to our management and involve significant elements of subjective judgment and analysis. Words such as “expects,” “will,” “anticipates,” “targets,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “potential,” “should,” “could,” variations of such words, and similar expressions are intended to identify forward-looking statements. Our actual results and the timing of events may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include those discussed under the heading “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2025, and in Part II, Item 1A of this Quarterly Report on Form 10-Q. These and many other factors could affect our future financial and operating results. We undertake no obligation to update any forward-looking statement to reflect events after the date of this Quarterly Report on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report on Form 10-Q. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into or review of, all relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely on these statements.
Overview
SCYNEXIS, Inc. is pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections. We are developing our proprietary antifungal platform “fungerps”, a novel class of antifungal agents called triterpenoids, that are structurally distinct glucan synthase inhibitors and have generally shown in vitro and in vivo activity against a broad range of human fungal pathogens such as Candida and Aspergillus genera, including multidrug-resistant strains, as well as Pneumocystis, Coccidioides, Histoplasma and Blastomyces genera and most common mucorales species.
Ibrexafungerp is the first representative of this novel class of antifungals and was approved by the U.S. Food and Drug Administration (FDA) as BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis (VVC) and for the reduction in the incidence of recurrent vulvovaginal candidiasis (rVVC) in 2021 and 2022, respectively.
A second generation fungerp SCY-247 is currently being evaluated in clinical trials and additional compounds from our proprietary fungerp platform, targeted to address significant unmet needs, are in earlier stages of development.
MARIO Study Update
As previously disclosed, we and GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) entered into an exclusive license agreement dated March 30, 2023, which was subsequently amended by the binding memorandums of understanding dated December 26, 2023 and October 14, 2025 (collectively, the GSK License Agreement).
Pursuant to the GSK License Agreement, we are responsible for conducting the MARIO study which resumed in April 2025 after the FDA notified us that the clinical hold of ibrexafungerp had been lifted, triggering us to bill a $10.0 million development milestone to GSK in the three months ended June 30, 2025. Subsequently, GSK notified us of their intention to immediately terminate the MARIO study based on GSK's purported rights under the GSK License Agreement. We did not believe that GSK had the right to unilaterally terminate the MARIO study under the GSK License Agreement.
In October 2025, we entered into a binding memorandum of understanding (the Binding 2025 MOU) with GSK and we agreed to promptly wind-down and terminate the MARIO study and we will receive one-time payments totaling $24.8 million from GSK. We will not receive any additional development milestone payments from GSK specifically associated with the MARIO study. Except as described above with respect to the MARIO study, the Binding 2025 MOU does not alter the potential milestones and royalties payable to us under the GSK License Agreement, including with regard to sales of BREXAFEMME for VVC and rVVC.
GSK has reiterated its commitment to continued collaboration with us regarding other aspects of the GSK License Agreement, including with respect to the commercialization of BREXAFEMME for VVC and rVVC indications. We are continuing to progress the transfer of the BREXAFEMME NDA (as defined in the Binding 2025 MOU) to GSK by the end of 2025. GSK anticipates being able to initiate regulatory interactions with the FDA in 2026 to discuss the relaunch of BREXAFEMME for VVC and rVVC in the U.S. market.
We remain committed to developing novel antifungal solutions to the rising threat of deadly fungal infections including invasive candidiasis for which there are limited treatment options and significant concerns for emergence of resistances, as highlighted by the World Health Organization in their call to industry and other parties for research, development and public health action in this area of unmet need.
14
SCY-247 Target Product Profile
SCY-247, the second agent in a novel antifungal class, acts through the inhibition of the glucan synthase complex, an established target in antifungal therapeutics. SCY-247 is being developed as oral and IV formulations and has demonstrated potent activity against a large collection of medically relevant strains of Candida and Aspergillus genera, including multidrug-resistant strains, as well as Pneumocystis, Coccidioides, Histoplasma and Blastomyces genera. Additionally, SCY-247 has shown in vitro, and in vivo activity against multidrug-resistant organisms such as Candida auris and synergistic/additive activity in combination with amphotericin B against fungi causing mucormycosis. SCY-247 has unique attributes that define its potential to address significant unmet medical needs and provide considerable commercial opportunities, including:
We believe that SCY-247, if approved, has the potential to address significant gaps with commercially available therapies in the following indications:
In the future, we may also consider other indications for SCY-247 for which longer oral antifungal regimens are typically needed and would benefit from the broad-spectrum activity, favorable safety profile and low potential for drug-drug interactions, including for the treatment of chronic fungal infections.
15
For the treatment of invasive fungal infections, we expect that prescribing physicians will be located at major medical centers, where physicians specializing in critical care, infectious disease specialists, and physicians treating immune compromised or immuno-suppressed patients, such as oncologists and those performing solid organ transplants and stem cell transplants, are likely to be found.
SCY-247 Development Update
We continue to progress the development activities for SCY-247 and recently completed the single and multiple ascending dose portions of our ongoing Phase 1 study of oral SCY-247 in 88 healthy subjects. The study evaluated the safety, tolerability and pharmacokinetics of orally administered SCY-247 in healthy participants receiving single ascending doses (SAD) ranging from 50mg to 900mg and multiple ascending doses (MAD) ranging from 50mg to 300mg, once a day for 7 days. Each dose level was evaluated in eight participants, with six participants receiving SCY-247 and two receiving a matching placebo. A total of 66 participants received SCY-247 and 22 received placebo in the SAD and MAD cohorts.
SCY-247 was well tolerated across all evaluated SAD and MAD cohorts. No serious or severe treatment emergent adverse events (TEAEs) were reported. The incidence of TEAEs was low and not dose-dependent, with all events being mild or moderate in severity. One participant discontinued the study due to an adverse event that was deemed not to be related to the study drug.
SCY-247 showed generally dose-proportional pharmacokinetics following single and multiple oral doses. The drug was rapidly absorbed (Tmax ranging from three to seven hours), and systemic exposure (Cmax and AUC) increased with dose. The MAD cohorts of 200mg and 300mg once-daily achieved or exceeded the preliminary target for efficacious exposure, based on preclinical models of invasive candidiasis available to date, including models with strains such as Candida auris and echinocandin-resistant Candida glabrata that are resistant to current antifungal treatment options. Overall, the safety, tolerability, and pharmacokinetic profile observed in this study support the continued clinical development of SCY-247.
We intend to progress the development of SCY-247 towards addressing significant unmet needs in the antifungal space that also represent attractive commercial opportunities. We anticipate initiating a Phase 1 study with the intravenous formulation in the first quarter of 2026. The clinical proof-of-concept Phase 2 study is planned in patients with invasive candidiasis and subsequent stages of development are anticipated to include studies adequate to support an invasive candidiasis treatment indication, as well as evaluating SCY-247 for the prevention of invasive fungal diseases in patients at high risk.
Nasdaq Minimum Bid Price Notification
On June 20, 2025, we received a letter from the Listing Qualifications Department staff (the Staff) of the Nasdaq notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the $1.00 per share minimum required for continued listing on the Nasdaq Global Market as set forth in Nasdaq Listing Rule 5450(a)(1). The letter from Nasdaq has no immediate effect on the listing of our common stock on the Nasdaq Global Market.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have 180 calendar days from June 20, 2025, or until December 17, 2025 (the Compliance Date), to regain compliance with the minimum bid price rule. Thereafter, if such a company does not regain compliance with the bid price requirement, a second 180-day compliance period may be available. If, at any time before the Compliance Date, the closing bid price of our common stock is at least $1.00 per share for a minimum of 10 consecutive business days, the Staff will provide us written confirmation of compliance with the minimum bid price rule and the matter will be closed.
Class Action Lawsuit
On November 7, 2023, a securities class action was filed by Brian Feldman against us and certain of our executives in the United States District Court, District of New Jersey, alleging misstatements from March 31, 2023 to September 22, 2023 regarding manufacturing controls and related risks. The court granted our motion to dismiss with leave to amend on July 30, 2025, and on August 29, 2025, the parties stipulated to dismissal and the court dismissed the case with prejudice. On May 1, 2024 and on June 4, 2024, purported shareholder derivative complaints asserting related claims were filed in the same court and later consolidated. On October 15, 2025, the court dismissed the consolidated case without prejudice. For additional information regarding the details of the securities class action and the consolidated shareholder derivative action, see Item 1 in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 filed on August 13, 2025.
Components of Operating Results
Revenue
Revenue consists of license agreement revenue associated with GSK License Agreement.
16
Research and Development Expense
Research and development expense consists of expenses incurred while performing research and development activities to discover, develop, or improve potential product candidates we seek to develop. This includes conducting preclinical studies and clinical trials, manufacturing and other development efforts, and activities related to regulatory filings for product candidates. We recognize research and development expenses as they are incurred. Our research and development expense primarily consists of:
Ibrexafungerp and SCY-247 were the only key research and development projects during the periods presented. We expect to continue to incur significant research and development expense for the foreseeable future as we continue our effort to develop SCY-247, and to potentially develop our other product candidates, subject to the availability of additional funding.
The successful development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of any product candidates. This is due to the numerous risks and uncertainties associated with the development of product candidates.
Selling, General and Administrative Expense
Selling, general and administrative expense consists primarily of salaries and personnel-related costs, including employee benefits and any stock-based compensation. This includes personnel in executive, finance, human resources, business development, medical affairs, marketing and commercial, and administrative support functions. Other expenses include facility-related costs not otherwise allocated to research and development expense, professional fees for accounting, auditing, tax and legal services, consulting costs for general and administrative purposes, patent application and legal fees, information systems and marketing efforts.
Other Expense (Income)
All of our other expense (income) recognized in the three and nine months ended September 30, 2025 and 2024, consists of amortization of debt issuance costs and discount, interest income, interest expense, the warrant liability fair value adjustment, and the derivative liability fair value adjustment.
Income Tax Expense
For the three and nine months ended September 30, 2024, our income tax expense recognized consists primarily of a benefit and an expense for U.S. federal income tax, respectively.
17
Results of Operations for the Three Months Ended September 30, 2025 and 2024
The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024, together with the changes in those items in dollars and percentage (dollars in thousands):
|
|
Three Months Ended September 30, |
|
|
|||||||||||||
|
|
2025 |
|
|
2024 |
|
|
Period-to-Period Change |
|
|
|||||||
License agreement revenue |
|
$ |
334 |
|
|
$ |
660 |
|
|
$ |
(326 |
) |
|
|
(49.4 |
) |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
5,452 |
|
|
|
8,073 |
|
|
|
(2,621 |
) |
|
|
(32.5 |
) |
% |
Selling, general and administrative |
|
|
3,287 |
|
|
|
2,907 |
|
|
|
380 |
|
|
|
13.1 |
|
% |
Total operating expenses |
|
|
8,739 |
|
|
|
10,980 |
|
|
|
(2,241 |
) |
|
|
(20.4 |
) |
% |
Loss from operations |
|
|
(8,405 |
) |
|
|
(10,320 |
) |
|
|
1,915 |
|
|
|
(18.6 |
) |
% |
Other (income) expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Amortization of debt issuance costs and discount |
|
|
— |
|
|
|
441 |
|
|
|
(441 |
) |
|
|
(100.0 |
) |
% |
Interest income |
|
|
(454 |
) |
|
|
(1,020 |
) |
|
|
566 |
|
|
|
(55.5 |
) |
% |
Interest expense |
|
|
— |
|
|
|
213 |
|
|
|
(213 |
) |
|
|
(100.0 |
) |
% |
Warrant liability fair value adjustment |
|
|
640 |
|
|
|
(6,751 |
) |
|
|
7,391 |
|
|
|
(109.5 |
) |
% |
Total other expense (income) |
|
|
186 |
|
|
|
(7,117 |
) |
|
|
7,303 |
|
|
|
(102.6 |
) |
% |
Loss before taxes |
|
|
(8,591 |
) |
|
|
(3,203 |
) |
|
|
(5,388 |
) |
|
|
168.2 |
|
% |
Income tax benefit |
|
|
— |
|
|
|
(395 |
) |
|
|
395 |
|
|
|
(100.0 |
) |
% |
Net loss |
|
$ |
(8,591 |
) |
|
$ |
(2,808 |
) |
|
$ |
(5,783 |
) |
|
|
205.9 |
|
% |
Revenue. For the three months ended September 30, 2025 and, 2024, revenue consists of $0.3 million and $0.7 million, respectively, in license agreement revenue associated with the GSK License Agreement.
Research and Development. For the three months ended September 30, 2025, research and development expenses decreased to $5.5 million compared to $8.1 million for the three months ended September 30, 2024. The decrease of $2.6 million, or 33%, for the three months ended September 30, 2025, was primarily driven by a decrease of $1.4 million in chemistry, manufacturing, and controls (CMC) expense, a decrease of $0.2 million in preclinical expense, a decrease of $0.2 million in clinical expense, a $0.2 million decrease in salary expense, a $0.3 million decrease in stock-based compensation expense, and a net decrease of $0.3 million in other research and development expense.
The $1.4 million decrease in CMC expense is primarily associated with a $1.5 million decrease in expense associated with the manufacturing of drug product for SCY-247 and ibrexafungerp. The $0.2 million decrease in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247 in the prior comparable period. The $0.2 million decrease in clinical expense was primarily due to a $0.5 million decrease in clinical expense for the FURI and CARES studies which were completed in the prior period, offset in part by a $0.3 million increase in clinical expense for the Phase 1 study for SCY-247. The decreases of $0.2 million in salary expense and $0.3 million in stock-based compensation expense are due to the decrease in the number of employees in the three months ended September 30, 2025.
Selling, General & Administrative. For the three months ended September 30, 2025, selling, general and administrative expenses increased to $3.3 million compared to $2.9 million for the three months ended September 30, 2024. The increase of $0.4 million, or 13%, for the three months ended September 30, 2025, was primarily driven by an increase of $0.3 million in professional fees.
Amortization of Debt Issuance Costs and Discount. For the three months ended September 30, 2025 and 2024, we recognized zero and $0.4 million in amortization of debt issuance costs and discount, respectively. The debt issuance costs and discount for our March 2019 convertible notes, which were fully paid at maturity in March 2025, primarily consisted of an allocated portion of advisory fees and other issuance costs and the initial fair value of the derivative liability.
Interest Income. For the three months ended September 30, 2025 and 2024, we recognized $0.5 million and $1.0 million, respectively, in interest income on our money market funds and investments.
Interest Expense. For the three months ended September 30, 2025 and 2024, we recognized zero and $0.2 million in interest expense on our March 2019 convertible notes which were fully paid at maturity in March 2025.
Warrant Liabilities Fair Value Adjustment. For the three months ended September 30, 2025 and 2024, we recognized a loss of $0.6 million and a gain of $6.8 million, respectively, in the fair value adjustment related to the warrant liabilities primarily due to the increase and decrease in our stock price during the respective periods.
18
Income Tax Benefit. For the three months ended September 30, 2024, we recognized a $0.4 million income tax benefit for U.S. federal income tax.
Results of Operations for the Nine Months Ended September 30, 2025 and 2024
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024, together with the changes in those items in dollars and percentage (dollars in thousands):
|
|
Nine Months Ended September 30, |
|
|
|||||||||||||
|
|
2025 |
|
|
2024 |
|
|
Period-to-Period Change |
|
|
|||||||
License agreement revenue |
|
$ |
1,955 |
|
|
$ |
2,769 |
|
|
$ |
(814 |
) |
|
|
(29.4 |
) |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
17,735 |
|
|
|
22,091 |
|
|
|
(4,356 |
) |
|
|
(19.7 |
) |
% |
Selling, general and administrative |
|
|
10,815 |
|
|
|
9,742 |
|
|
|
1,073 |
|
|
|
11.0 |
|
% |
Total operating expenses |
|
|
28,550 |
|
|
|
31,833 |
|
|
|
(3,283 |
) |
|
|
(10.3 |
) |
% |
Loss from operations |
|
|
(26,595 |
) |
|
|
(29,064 |
) |
|
|
2,469 |
|
|
|
(8.5 |
) |
% |
Other expense (income): |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Amortization of debt issuance costs and discount |
|
|
312 |
|
|
|
1,262 |
|
|
|
(950 |
) |
|
|
(75.3 |
) |
% |
Interest income |
|
|
(1,759 |
) |
|
|
(3,422 |
) |
|
|
1,663 |
|
|
|
(48.6 |
) |
% |
Interest expense |
|
|
173 |
|
|
|
617 |
|
|
|
(444 |
) |
|
|
(72.0 |
) |
% |
Warrant liabilities fair value adjustment |
|
|
(4,454 |
) |
|
|
(10,598 |
) |
|
|
6,144 |
|
|
|
(58.0 |
) |
% |
Derivative liabilities fair value adjustment |
|
|
— |
|
|
|
(196 |
) |
|
|
196 |
|
|
|
(100.0 |
) |
% |
Total other income |
|
|
(5,728 |
) |
|
|
(12,337 |
) |
|
|
6,609 |
|
|
|
(53.6 |
) |
% |
Loss before taxes |
|
|
(20,867 |
) |
|
|
(16,727 |
) |
|
|
(4,140 |
) |
|
|
24.8 |
|
% |
Income tax expense |
|
|
— |
|
|
|
128 |
|
|
|
(128 |
) |
|
|
(100.0 |
) |
% |
Net loss |
|
$ |
(20,867 |
) |
|
$ |
(16,855 |
) |
|
$ |
(4,012 |
) |
|
|
23.8 |
|
% |
Revenue. For the nine months ended September 30, 2025 and, 2024, revenue consists of $2.0 million and $2.8 million, respectively, in license agreement revenue associated with the GSK License Agreement.
Research and Development. For the nine months ended September 30, 2025, research and development expenses decreased to $17.7 million compared to $22.1 million for the nine months ended September 30, 2024. The decrease of $4.4 million, or 20%, for the nine months ended September 30, 2025, was primarily driven by a decrease of $2.7 million in CMC expense, a decrease of $0.7 million in clinical expense, a decrease of $0.4 million in salary expense, a $0.3 million decrease in stock-based compensation and a net decrease in other research and development expense of $0.9 million, offset in part by an increase of $0.6 million in preclinical expense.
The $2.7 million decrease in CMC expense is primarily associated with a $3.1 million decrease in expense associated with the manufacturing of drug product for SCY-247 and ibrexafungerp. The $0.7 million decrease in clinical expense was primarily due to a $1.9 million decrease in clinical expense for the FURI and CARES studies which were completed in the prior period, a $0.3 million decrease in clinical expense associated with the VANQUISH study, and a net decrease of $1.0 million in other clinical expense, offset in part by a $2.5 million increase in clinical expense for the Phase 1 study for SCY-247. The decreases of $0.4 million in salary expense and $0.3 million in stock-based compensation expense are due to the decrease in the number of employees in the nine months ended September 30, 2025. The $0.6 million increase in preclinical expense was primarily associated with certain preclinical costs associated with the continued development of SCY-247 in the current period.
Selling, General & Administrative. For the nine months ended September 30, 2025, selling, general and administrative expense increased to $10.8 million compared to $9.7 million for the nine months ended September 30, 2024. The increase of $1.1 million, or 11%, for the nine months ended September 30, 2025, was primarily driven by an increase of $0.5 million in business development expense, an increase of $0.3 million in salary expense, and a net increase of $0.3 million in other selling, general, and administrative expense.
Amortization of Debt Issuance Costs and Discount. For the nine months ended September 30, 2025 and 2024, we recognized $0.3 million and $1.3 million in amortization of debt issuance costs and discount, respectively. The debt issuance costs and discount for our March 2019 convertible notes, which were fully paid at maturity in March 2025, primarily consisted of an allocated portion of advisory fees and other issuance costs and the initial fair value of the derivative liability.
Interest Income. For the nine months ended September 30, 2025 and 2024, we recognized $1.8 million and $3.4 million, respectively, in interest income on our money market funds and investments.
19
Interest Expense. For the nine months ended September 30, 2025 and 2024, we recognized $0.2 million and $0.6 million in interest expense on our March 2019 convertible notes which were fully paid at maturity in March 2025.
Warrant Liabilities Fair Value Adjustment. For the nine months ended September 30, 2025 and 2024, we recognized gains of $4.5 million and $10.6 million, respectively, in the fair value adjustment related to the warrant liabilities primarily due to the decrease in our stock price during the periods.
Derivative Liability Fair Value Adjustment. For the nine months ended September 30, 2024, we recognized a gain of $0.2 million in the fair value adjustment related to the derivative liability primarily due to the decrease in our stock price during the period.
Income Tax Expense. For the nine months ended September 30, 2024, our income tax expense recognized consists primarily of an expense for U.S. federal income tax.
Liquidity and Capital Resources
Sources of Liquidity
As of September 30, 2025, we had cash and cash equivalents and investments of $37.9 million, compared to cash and cash equivalents and short-term investments of $75.1 million as of December 31, 2024. We believe our capital resources are sufficient to fund our on-going operations for a period of at least 12 months subsequent to the issuance of the accompanying unaudited condensed consolidated financial statements. As of September 30, 2025, our accumulated deficit was $397.4 million.
Consistent with our operating plan, we expect to incur significant research and development expenses and selling, general and administrative expenses. As a result of our continued significant expenses, we will need additional capital to fund our operations, which we may obtain through one or more of equity offerings, debt financings, other non-dilutive third-party funding (e.g., grants), strategic alliances and licensing or collaboration arrangements. We may offer shares of our common stock pursuant to our effective shelf registration statements or our “at-the-market” offering program pursuant to the Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co.
Cash Flows
The following table sets forth the significant sources and uses of cash for the nine months ended September 30, 2025 and 2024 (in thousands):
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Cash, cash equivalents, and restricted cash, January 1 |
|
$ |
16,595 |
|
|
$ |
34,593 |
|
Net cash used in operating activities |
|
|
(23,684 |
) |
|
|
(14,102 |
) |
Net cash provided by investing activities |
|
|
36,130 |
|
|
|
8,767 |
|
Net cash (used in) provided by financing activities |
|
|
(14,055 |
) |
|
|
16 |
|
Net decrease in cash, cash equivalents, and restricted cash |
|
|
(1,609 |
) |
|
|
(5,319 |
) |
Cash, cash equivalents, and restricted cash, September 30 |
|
$ |
14,986 |
|
|
$ |
29,274 |
|
Operating Activities
The $9.6 million increase in net cash used in operating activities for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024 was primarily due to the continued development costs associated with SCY-247 and ibrexafungerp in the nine months ended September 30, 2025.
Net cash used in operating activities of $23.7 million for the nine months ended September 30, 2025, primarily consisted of the $20.9 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant liability of $4.5 million and stock-based compensation expense of $2.2 million, partially offset by a net unfavorable change in operating assets and liabilities of $0.7 million. The net unfavorable change in operating assets and liabilities of $0.7 million is due to a net favorable change of $2.0 million due to the decrease in operating assets offset by a net unfavorable change of $2.7 million due to the decrease in operating liabilities. The net $2.0 million decrease in operating assets is primarily due to a $1.7 million decrease in prepaid expenses, other assets, deferred costs, and other. The $1.7 million decrease in prepaid expenses, other assets, deferred costs, and other was primarily due to the $1.2 million decrease in other current assets for certain collected unbilled receivables in the nine months ended September 30, 2025. The net unfavorable change of $2.7 million in operating liabilities is primarily due to the $1.0 million decrease in accounts payable and a $1.0 million decrease in accrued expenses primarily due to the $0.6 million decrease in accrued bonus which was paid in the nine months ended September 30, 2025.
Net cash used in operating activities of $14.1 million for the nine months ended September 30, 2024, primarily consisted of the $16.9 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant
20
liabilities of $10.6 million, stock-based compensation expense of $2.4 million, and amortization of debt issuance costs and discount of $1.3 million, partially offset by a net favorable change in operating assets and liabilities of $10.8 million. The net favorable change in operating assets and liabilities of $10.8 million is due to a favorable change of $16.2 million due to the decrease in operating assets, offset by an unfavorable change of $5.4 million due to the decrease in operating liabilities The net $16.2 million decrease in operating assets is primarily due to a decrease of $9.9 million in the license agreement contract asset given the receipt of the $10.0 million development milestone associated with the GSK License Agreement in the nine months ended September 30, 2024, a $2.3 million decrease in the license agreement receivable associated with the GSK License Agreement which was collected in the nine months ended September 30, 2024, and a $4.0 million decrease in prepaid expenses, other assets, deferred costs, and other. The $4.0 million decrease in prepaid expenses, other assets, deferred costs, and other was primarily due to the collection of a $4.4 million unbilled receivable in the nine months ended September 30, 2024 from GSK. The net unfavorable change of $5.4 million in operating liabilities is primarily due to the $2.2 million decrease in accounts payable and a $2.0 million decrease in accrued expenses primarily resulting from the $1.0 million decrease in accrued research and development expenses.
Investing Activities
Net cash provided by investing activities for the nine months ended September 30, 2025 consisted of the maturities of investments of $36.1 million.
Net cash provided by investing activities of $8.8 million for the nine months ended September 30, 2024 consisted of purchases and maturities of investments of $28.0 million and $36.8 million, respectively.
Financing Activities
Net cash used in financing activities of $14.1 million for the nine months ended September 30, 2025, consisted primarily of the $14.0 million repayment of the convertible debt in March 2025.
Net cash provided by financing activities of $16,000 for the nine months ended September 30, 2024, consisted primarily of the proceeds from employee stock purchase plan issuances.
Future Funding Requirements
We expect to incur expenses in connection with our efforts to further development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, product candidates. We anticipate that we will need substantial additional funding in connection with our continuing future operations.
We are continually evaluating our operating plan and assessing the optimal cash utilization for our SCY-247 development strategy. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses necessary to complete the development of product candidates.
Our future capital requirements will depend on many factors, including:
21
Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our cash needs through a combination of net proceeds from equity offerings, debt financings, or other non-dilutive third-party funding (e.g., grants), strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through sales of assets, other third-party funding, strategic alliances and licensing or collaboration arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.
Significant Estimates and Judgments
Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of our condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our condensed consolidated financial statements, as well as the reported revenues and expenses during the reported periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Our critical estimates and judgments are described within Item 7 to our Annual Report on Form 10-K for the year ended December 31, 2024.
Item 4. Controls and Procedures.
Management’s Evaluation of our Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934, as amended (the "Exchange Act") is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.
As of September 30, 2025, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executive officer and principal financial officer have concluded based upon the evaluation described above that, as of September 30, 2025, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
During the three months ended September 30, 2025, there have been no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II.
Item 1. Legal Proceedings.
The information called for by this Item is incorporated herein by reference to Note 6 included in Part I, Item 1, Financial Statements — Notes to the Condensed Consolidated Financial Statements (unaudited).
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Item 6. Exhibits.
Exhibit Number |
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Description of Document |
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3.1 |
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3.2 |
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3.3 |
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3.4 |
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3.5 |
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4.1 |
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31.1* |
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31.2* |
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32.1** |
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101.INS |
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Inline XBRL Instance Document |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents. |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
* Filed herewith.
** Furnished herewith. Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SCYNEXIS, INC. |
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By: |
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/s/ David Angulo, M.D. |
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David Angulo, M.D. |
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Chief Executive Officer (Principal Executive Officer) |
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Date: |
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November 4, 2025 |
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By: |
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/s/ Ivor Macleod |
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Ivor Macleod |
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Chief Financial Officer (Principal Financial and Accounting Officer) |
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Date: |
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November 4, 2025 |
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Exhibit 31.1
CERTIFICATIONS
I, David Angulo, certify that:
Date: November 4, 2025
/s/ David Angulo, M.D. |
David Angulo, M.D. Chief Executive Officer Principal Executive Officer |
Exhibit 31.2
CERTIFICATIONS
I, Ivor Macleod, certify that:
Date: November 4, 2025
/s/ Ivor Macleod |
Ivor Macleod Chief Financial Officer Principal Financial Officer |
Exhibit 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), David Angulo, Chief Executive Officer of SCYNEXIS, Inc. (the “Company”), and Ivor Macleod, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:
In Witness Whereof, the undersigned have set their hands hereto as of November 4, 2025.
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/s/ David Angulo, M.D. |
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/s/ Ivor Macleod |
David Angulo, M.D. Chief Executive Officer |
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Ivor Macleod Chief Financial Officer |
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of SCYNEXIS, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.