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)
| | |
Delaware | | 56-2181648 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| | |
1 Evertrust Plaza, 13th Floor Jersey City, New Jersey | | 07302-6548 |
(Address of principal executive offices) | | (Zip Code) |
(201)-884-5485
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| | |
Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered |
Common Stock, par value $0.001 per share | SCYX | Nasdaq Global Market |
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. Yes ☒ No ☐
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). Yes ☒ No ☐
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 | | ☐ | | Accelerated filer | | ☐ |
| | | |
Non-accelerated filer | | ☒ | | Smaller reporting company | | ☒ |
| | | |
Emerging growth company | | ☐ | | | | |
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 May 1, 2023, there were 36,517,442 shares of the registrant’s Common Stock outstanding.
Table of Contents
SCYNEXIS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2023
TABLE OF CONTENTS
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
SCYNEXIS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| | | | | | | | |
| | March 31, 2023 | | | December 31, 2022 | |
Assets | | | | | | |
Current assets: | | | | | | |
Cash and cash equivalents | | $ | 26,913 | | | $ | 45,814 | |
Short-term investments | | | 27,908 | | | | 27,689 | |
Prepaid expenses and other current assets | | | 1,726 | | | | 2,503 | |
Accounts receivable, net | | | 2,060 | | | | 2,101 | |
Inventory, net | | | 1,105 | | | | 899 | |
Restricted cash | | | 55 | | | | 55 | |
Total current assets | | | 59,767 | | | | 79,061 | |
Other assets | | | 7,444 | | | | 5,511 | |
Deferred offering costs | | | 73 | | | | 73 | |
Restricted cash | | | 163 | | | | 163 | |
Intangible assets, net | | | 309 | | | | 408 | |
Operating lease right-of-use asset (See Note 8) | | | 2,540 | | | | 2,594 | |
Total assets | | $ | 70,296 | | | $ | 87,810 | |
Liabilities and stockholders’ equity | | | | | | |
Current liabilities: | | | | | | |
Accounts payable | | $ | 5,925 | | | $ | 5,937 | |
Accrued expenses | | | 4,775 | | | | 5,628 | |
Other liabilities, current portion (See Note 7) | | | — | | | | 5,771 | |
Operating lease liability, current portion (See Note 8) | | | 296 | | | | 282 | |
Loan payable, current portion | | | 34,648 | | | | — | |
Total current liabilities | | | 45,644 | | | | 17,618 | |
Warrant liabilities | | | 40,317 | | | | 18,644 | |
Convertible debt and derivative liability (See Note 7) | | | 11,407 | | | | 11,001 | |
Loan payable | | | — | | | | 34,393 | |
Operating lease liability (See Note 8) | | | 2,842 | | | | 2,921 | |
Total liabilities | | | 100,210 | | | | 84,577 | |
Commitments and contingencies | | | | | | |
Stockholders’ equity: | | | | | | |
Preferred stock, $0.001 par value, authorized 5,000,000 shares as of March 31, 2023 and December 31, 2022; 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | | | — | | | | — | |
Common stock, $0.001 par value, 150,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 33,327,627 and 32,682,342 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | | | 36 | | | | 36 | |
Additional paid-in capital | | | 426,214 | | | | 425,485 | |
Accumulated deficit | | | (456,164 | ) | | | (422,288 | ) |
Total stockholders’ (deficit) equity | | | (29,914 | ) | | | 3,233 | |
Total liabilities and stockholders’ equity | | $ | 70,296 | | | $ | 87,810 | |
The accompanying notes are an integral part of the financial statements.
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SCYNEXIS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
| | | | | | | | |
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Revenue: | | | | | | |
Product revenue, net | | $ | 1,130 | | | $ | 687 | |
Operating expenses: | | | | | | |
Cost of product revenue | | | 137 | | | | 99 | |
Research and development | | | 6,835 | | | | 5,735 | |
Selling, general and administrative | | | 4,840 | | | | 14,591 | |
Total operating expenses | | | 11,812 | | | | 20,425 | |
Loss from operations | | | (10,682 | ) | | | (19,738 | ) |
Other expense (income): | | | | | | |
Amortization of debt issuance costs and discount | | | 255 | | | | 390 | |
Interest income | | | (587 | ) | | | (13 | ) |
Interest expense | | | 1,447 | | | | 1,059 | |
Other income | | | — | | | | (13 | ) |
Warrant liabilities fair value adjustment | | | 21,673 | | | | (10,030 | ) |
Derivative liabilities fair value adjustment | | | 406 | | | | (980 | ) |
Total other expense (income) | | | 23,194 | | | | (9,587 | ) |
Loss before taxes | | | (33,876 | ) | | | (10,151 | ) |
Income tax benefit | | | — | | | | (4,700 | ) |
Net loss | | $ | (33,876 | ) | | $ | (5,451 | ) |
Net loss per share attributable to common stockholders – basic | | | | | | |
Net loss per share – basic | | $ | (0.71 | ) | | $ | (0.17 | ) |
Net loss per share attributable to common stockholders – diluted | | | | | | |
Net loss per share – diluted | | $ | (0.71 | ) | | $ | (0.18 | ) |
Weighted average common shares outstanding – basic and diluted | | | | | | |
Basic | | | 47,757,246 | | | | 32,051,228 | |
Diluted | | | 47,757,246 | | | | 33,189,428 | |
The accompanying notes are an integral part of the financial statements.
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SCYNEXIS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
| | | | | | | | |
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Cash flows from operating activities: | | | | | | |
Net loss | | $ | (33,876 | ) | | $ | (5,451 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | |
Depreciation and amortization | | | 151 | | | | 155 | |
Stock-based compensation expense | | | 707 | | | | 922 | |
Accretion of short-term investment discount | | | (219 | ) | | | — | |
Amortization of debt issuance costs and discount | | | 255 | | | | 390 | |
Change in fair value of warrant liabilities | | | 21,673 | | | | (10,030 | ) |
Change in fair value of derivative liabilities | | | 406 | | | | (980 | ) |
Noncash operating lease expense for right-of-use asset | | | 54 | | | | 52 | |
Write off of deferred asset for commitment fees | | | 514 | | | | — | |
Changes in operating assets and liabilities: | | | | | | |
Prepaid expenses, accounts receivable, inventory, and other | | | (1,887 | ) | | | (1,429 | ) |
Accounts payable, accrued expenses, other liabilities, and other | | | (6,701 | ) | | | 383 | |
Net cash used in operating activities | | | (18,923 | ) | | | (15,988 | ) |
Cash flows from investing activities: | | | | | | |
Purchase of intangible assets | | | — | | | | (9 | ) |
Net cash used in investing activities | | | — | | | | (9 | ) |
Cash flows from financing activities: | | | | | | |
Proceeds from common stock issued | | | — | | | | 2,164 | |
Payments of offering costs and underwriting discounts and commissions | | | — | | | | (451 | ) |
Proceeds from loan payable | | | — | | | | 5,000 | |
Proceeds from employee stock purchase plan issuances | | | 4 | | | | 10 | |
Repurchase of shares to satisfy tax withholdings | | | 18 | | | | — | |
Net cash provided by financing activities | | | 22 | | | | 6,723 | |
Net decrease in cash, cash equivalents, and restricted cash | | | (18,901 | ) | | | (9,274 | ) |
Cash, cash equivalents, and restricted cash at beginning of period | | | 46,032 | | | | 104,702 | |
Cash, cash equivalents, and restricted cash at end of period | | $ | 27,131 | | | $ | 95,428 | |
Supplemental cash flow information: | | | | | | |
Cash paid for interest | | $ | 1,658 | | | $ | 1,099 | |
Cash received for interest | | $ | 373 | | | $ | 12 | |
Noncash financing and investing activities: | | | | | | |
Deferred offering and issuance costs included in accounts payable and accrued expenses | | $ | — | | | $ | 26 | |
Deferred offering costs reclassified to additional paid-in capital | | $ | — | | | $ | 27 | |
Reclass of warrant liability to additional paid-in capital | | $ | — | | | $ | 71 | |
Reclass of deferred asset associated with issuance of loan payable to debt discount | | $ | — | | | $ | 206 | |
The accompanying notes are an integral part of the financial statements.
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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 lead product candidate, ibrexafungerp, as a broad-spectrum, intravenous (“IV”)/oral agent for severe, hospital-based indications. In June 2021, the U.S. Food and Drug Administration (“FDA”) approved BREXAFEMME® (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis (“VVC”), also known as vaginal yeast infection. In December 2022, the Company announced that the FDA approved a second indication for BREXAFEMME for the reduction in the incidence of recurrent vulvovaginal candidiasis ("RVVC").
In March 2023, the Company entered into a license agreement (the "License Agreement") with GlaxoSmithKline Intellectual Property (No. 3) Limited ("GSK"), subject to customary closing conditions, in which the Company granted GSK an exclusive (even as to the Company and its affiliates), royalty-bearing, sublicensable license for the development and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in all countries other than Greater China and certain other countries already licensed to third parties (See Note 12). The parties expect the transactions contemplated by the License Agreement to close in the second quarter of 2023.
The Company is party to a Loan and Security Agreement, dated May 13, 2021, with Hercules Capital, Inc. ("Hercules Capital") and Silicon Valley Bridge Bank, N.A. (now a division of First Citizens Bank, “SVB”) (the "Loan Agreement"), pursuant to which Hercules Capital, SVB and each of the other lenders from time-to-time party to the Loan Agreement (collectively, the “Lenders”) loaned to the Company $35.0 million as of March 31, 2023.
In connection with the entering into of the License Agreement, the Company entered into a First Amendment and Consent to Loan and Security Agreement with the Lenders pursuant to the Lenders consented to the Company entering into the License Agreement and the Company agreed to pay to the Lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement, (ii) the prepayment fee payable under the Loan Agreement (approximately $0.3 million), (iii) the final payment payable under the Loan Agreement (approximately $1.4 million), and (iv) all other sums, if any, that shall have become due and payable with respect to loan advances under the Loan Agreement. These payments by the Company will become due upon the earliest of (A) one business day following receipt by the Company of the $90 million upfront payment payable to the Company under the License Agreement, (B) June 1, 2023, or (C) the termination of the License Agreement.
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.
Liquidity and Going Concern
The Company has funded its operations primarily through a combination of net proceeds from equity offerings, debt financings, and other non-dilutive third-party funding (e.g., grants), strategic alliances and licensing arrangements. To date, the Company has generated minimal revenue from product sales. The Company does not know if or when the Company will be able to generate significant revenue from product sales. In addition, the Company expects to incur expenses in connection with the Company's ongoing development activities, particularly as the Company continues the research, development and clinical trials of, and seek regulatory approval for, its product candidates. The Company anticipates that it will need substantial additional funding in connection with its continuing future operations.
As of the date the accompanying unaudited condensed consolidated financial statements were issued (the “issuance date”), management evaluated the significance of the following negative financial conditions in accordance with ASC 205-40, Going Concern:
•The Company has incurred recurring losses since its inception, including net losses of $33.9 million for the three months ended March 31, 2023, and $62.8 million for the year ended December 31, 2022. In addition, as of March 31, 2023, the Company had an accumulated deficit of $456.2 million. The Company expects to continue to generate operating losses for the foreseeable future.
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•As of March 31, 2023, the Company had approximately $54.8 million of unrestricted cash, cash equivalents and short-term investments available to fund the Company’s operations.
•The Company expects to incur substantial expenditures to fund its operations and ongoing development activities for the foreseeable future. In order to fund its operations and ongoing development activities, the Company will need to secure additional sources of outside capital. As noted above and as further disclosed in Note 12, the Company entered into a License Agreement with GSK in March 2023, in which the Company granted GSK with an exclusive license for the development and commercialization of ibrexafungerp, including the approved product BREXAFEMME. The closing of the License Agreement is subject to the satisfaction of customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and therefore the related cash flows, including the upfront payment of $90.0 million, were not included in the Company’s ASC 205-40 analysis as of the issuance date. Management expects the License Agreement to close during the second quarter of 2023.
•In the event the License Agreement does not close, the Company may be unable to meet its obligations as they become due over the next twelve months beyond the issuance date. In that regard, management will be required to seek other strategic alternatives, which may include, raising additional capital through equity offerings, including utilizing our existing facility, debt financings, or other non-dilutive third-party funding. While the Company has a history of successfully raising capital in this manner, management can provide no assurance that additional capital will be secured or on terms that are acceptable to the Company. In the event the Company is unable to secure additional capital, management will be required to seek other strategic alternatives, which may include, among others, delaying expenditures, reducing the scope of its research and development programs, significant changes to its operating plan, a sale of certain of the Company’s assets, a sale of the entire Company to strategic or financial investors, and/or allowing the Company to become insolvent by filing for bankruptcy.
•As disclosed in Note 7, the Company is required to maintain compliance with certain covenants prescribed by the Term Loan. The first covenant pertains to a minimum cash requirement whereby the Company must maintain a minimum amount of unrestricted and unencumbered cash in accounts with the lenders at all times that represents at least 50% of the outstanding principal on the Term Loan (the “minimum cash”). In the event the minimum cash is not maintained, the second covenant requires the Company to maintain compliance with a trailing three-month net product revenue threshold (the “revenue covenant”). As of March 31, 2023 and through the issuance date, the Company met the minimum cash requirement. However, management can provide no assurance that the minimum cash will be maintained for at least twelve months beyond the issuance date. If the Company does not meet the minimum cash requirement and, as such, must maintain compliance with the revenue covenant, management does not expect the Company will be able to comply with the revenue covenant for any period over the next twelve months beyond the issuance date. If the Company is required to comply with, but does not maintain compliance with, the revenue covenant, management may seek a waiver from the lender or refinance the outstanding borrowings under the Term Loan with another lender. However, management can provide no assurance a waiver will be granted by the lender or on terms that are acceptable to the Company. Similarly, management can provide no assurance that the Company will be able to refinance the amounts outstanding on the Term Loan or obtain a new loan on terms that are acceptable to the Company. In the event a waiver is not granted, or the Term Loan is not refinanced, the lender may exercise any and all of its rights and remedies provided for under the borrowing agreement which may include, among others, entering into a forbearance agreement, demanding payment, and/or seizing the underlying assets secured by the Term Loan.
•Further, as noted above, the Company entered into an amendment to the Loan Agreement in March 2023, which amends the original terms of the Loan Agreement to require that the outstanding principal and accrued and unpaid interest amounts, the prepayment fee and the final payment will become due and payable at the earliest of (A) one business day following receipt by the Company of the upfront payment payable to the Company under the License Agreement, (B) June 1, 2023, or (C) the termination of the License Agreement. While management expects that the License Agreement will close during the second quarter of 2023, if the License Agreement were unable to close or were to close at a later date than originally expected, the amendment to the Loan agreement would require the Company to repay the amounts due under the Loan Agreement potentially prior to the close of the License Agreement.
These uncertainties raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited condensed consolidated financial statements have been prepared on the basis that the Company will continue to operate as a going concern, which contemplates that the Company will be able to realize assets and settle liabilities and commitments in the normal course of business for twelve months following the issuance date. Accordingly, the accompanying unaudited condensed consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties.
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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: revenue recognition including gross to net estimates and the identification of performance obligations in licensing arrangements; 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 values of the warrant and derivative liabilities 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 months ended March 31, 2023, 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 31, 2023.
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, 2022, except as described below.
Allowance for Credit Losses
The Company reviews its held-to-maturity short-term investments for credit losses on a collective basis by major security type and in line with the Company's investment policy. As of March 31, 2023, the Company's held-to-maturity short-term investments were in securities that are issued by the U.S. government, are highly rated, and have a history of zero credit losses. The Company reviews the credit quality of its accounts receivables by monitoring the aging of its accounts receivable, the history of write offs for uncollectible accounts, and the credit quality of its significant customers, the current economic environment/macroeconomic trends, supportable forecasts, and other relevant factors. The Company's accounts receivable are with customers that do not have a history of uncollectibility nor a history of significantly aged accounts receivables. As of March 31, 2023, the Company did not recognize a credit loss allowance for its short-term investments or accounts receivable.
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 months ended March 31, 2023 and 2022 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 months ended March 31, 2023 includes the outstanding pre-funded warrants to purchase 11,303,667 and 3,200,000 shares of common stock issued in the April 2022 public offering and December 2020 public offering, respectively. The outstanding pre-funded warrants to purchase 3,200,000 shares of common stock issued in the December 2020 public offering were included in the three months ended March 31, 2022. Diluted net loss per common share for the three months ended March 31, 2023 and 2022 was determined as follows (in thousands, except share and per share amounts):
| | | | | | | |
| Three Months Ended March 31, | |
| 2023 | | | 2022 | |
Net loss | $ | (33,876 | ) | | $ | (5,451 | ) |
Dilutive effect of convertible debt | | — | | | | (584 | ) |
Net loss allocated to common shares | $ | (33,876 | ) | | $ | (6,035 | ) |
| | | | | |
Weighted average common shares outstanding – basic | | 47,757,246 | | | | 32,051,228 | |
Dilutive effect of convertible debt | | — | | | | 1,138,200 | |
Weighted average common shares outstanding – diluted | | 47,757,246 | | | | 33,189,428 | |
| | | | | |
Net loss per share – diluted | $ | (0.71 | ) | | $ | (0.18 | ) |
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The following potentially dilutive shares of common stock have not been included in the computation of diluted net loss per share for the three months ended March 31, 2023 and 2022, as the result would be anti-dilutive:
| | | | | | | |
| Three Months Ended March 31, | |
| 2023 | | | 2022 | |
Outstanding stock options | | 1,931,389 | | | | 2,050,094 | |
Outstanding restricted stock units | | 2,214,490 | | | | 981,841 | |
Warrants to purchase common stock associated with March 2018 public offering – Series 2 | | — | | | | 798,810 | |
Warrants to purchase common stock associated with December 2020 public offering - Series 2 | | 6,800,000 | | | | 6,800,000 | |
Warrants to purchase common stock associated with April 2022 Public Offering | | 15,000,000 | | | | — | |
Warrants to purchase common stock associated with Loan Agreement | | 198,811 | | | | 198,819 | |
Common stock associated with March 2019 Notes | | 1,138,200 | | | | — | |
Warrants to purchase common stock associated with Danforth | | 50,000 | | | | 50,000 | |
Total | | 27,332,890 | | | | 10,879,564 | |
Recently Adopted Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The amendments in ASU 2016-13 require a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) (“ASU 2019-10”), which revised the effective dates for ASU 2016-13 for public business entities that meet the SEC definition of a smaller reporting company to fiscal years, and interim periods within those fiscal years, beginning after December 15, 2022, with early adoption permitted. The Company adopted ASU 2016-13 during the three months ended March 31, 2023 and the adoption did not materially impact the unaudited condensed consolidated financial statements.
Recently Issued Accounting Pronouncements
In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options and Derivatives and Hedging—Contracts in Entity’s Own Equity: Accounting for Convertible Instruments and Contracts in and Entity’s Own Equity (“ASU 2020-06”). The amendments in ASU 2020-06 reduce the number of accounting models for convertible debt instruments and revises certain guidance relating to the derivative scope exception and earnings per share. The amendments in ASU 2020-06 are effective for public business entities that meet the definition of a SEC filer and a smaller reporting company for fiscal years beginning after December 15, 2023, and interim periods within those years. As a smaller reporting company, the Company is currently evaluating the impact ASU 2020-06 will have on its unaudited condensed consolidated financial statements.
3. Short-term Investments
The following table summarizes the short-term investments at March 31, 2023 (in thousands):
| | | | | | | | | | | | | | | | |
| | Amortized
Cost | | | Unrealized
Gains | | | Unrealized
Losses | | | Fair Value | |
As of March 31, 2023 | | | | | | | | | | | | |
U.S. government securities | | $ | 27,908 | | | $ | — | | | $ | (64 | ) | | $ | 27,844 | |
Total short-term investments | | $ | 27,908 | | | $ | — | | | $ | (64 | ) | | $ | 27,844 | |
| | | | | | | | | | | | |
As of December 31, 2022 | | | | | | | | | | | | |
U.S. government securities | | $ | 27,689 | | | $ | — | | | $ | (160 | ) | | $ | 27,529 | |
Total short-term investments | | $ | 27,689 | | | $ | — | | | $ | (160 | ) | | $ | 27,529 | |
As of March 31, 2023, the Company has $27.9 million of held-to-maturity investments with contractual maturities less than one year. The Company carries short-term investments at amortized cost. The fair value of the short-term investments is determined based on “Level 1” inputs, which consist of quoted prices in active markets for identical assets. The Company has evaluated the unrealized loss position in the U.S. government securities as of the balance sheet date and did not consider it to be indicative of an other-than-temporary impairment as the securities are highly-rated and the Company expects to realize the full principal amount at maturity.
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4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| | | | | | | | |
| | March 31, 2023 | | | December 31, 2022 | |
Prepaid research and development services | | $ | 569 | | | $ | 635 | |
Prepaid insurance | | | 328 | | | | 622 | |
Other prepaid expenses | | | 538 | | | | 1,184 | |
Other current assets | | | 291 | | | | 62 | |
Total prepaid expenses and other current assets | | $ | 1,726 | | | $ | 2,503 | |
5. Inventory
Inventory consisted of the following (in thousands):
| | | | | | | | |
| | March 31, 2023 | | | December 31, 2022 | |
Raw materials | | $ | 7,724 | | | $ | 5,093 | |
Work in process | | | 698 | | | | 610 | |
Finished goods | | | 11 | | | | 24 | |
Total inventory | | $ | 8,433 | | | $ | 5,727 | |
As of March 31, 2023 and December 31, 2022, the Company’s inventory consisted of $7.3 million and $4.9 million, respectively, of raw material that is not expected to be sold in one year and is classified as long term within other assets on the accompanying unaudited condensed consolidated balance sheet.
6. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| | | | | | | | |
| | March 31, 2023 | | | December 31, 2022 | |
Accrued research and development expenses | | $ | 1,249 | | | $ | 786 | |
Accrued employee bonus compensation | | | 498 | | | | 1,628 | |
Other accrued expenses | | | 1,543 | | | | 1,313 | |
Accrued severance | | | 28 | | | | 688 | |
Accrued co-pay rebates | | | 760 | | | | 595 | |
Accrued other rebates | | | 697 | | | | 618 | |
Total accrued expenses | | $ | 4,775 | | | $ | 5,628 | |
7. Borrowings
Loan Agreement
On May 13, 2021 (the “Closing Date”), the Company entered into the Loan Agreement with Hercules and SVB for an aggregate principal amount of $60.0 million (the “Term Loan”). Pursuant to the Loan Agreement, the Term Loan is available to the Company in four tranches, subject to certain terms and conditions.
In connection with the entering into of the License Agreement, the Company entered into a First Amendment and Consent to Loan and Security Agreement with the Lenders pursuant to which the Lenders consented to the Company entering into the License Agreement and the Company agreed to pay to the Lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement (approximately $35.4 million), (ii) the prepayment fee payable under the Loan Agreement ($262,500), (iii) the final payment payable under the Loan Agreement ($1,382,500), and (iv) all other sums, if any, that shall have become due and payable with respect to loan advances under the Loan Agreement. These payments by the Company will become due upon the earliest of (A) one business day following receipt by the Company of the $90 million upfront payment payable to the Company under the License Agreement, (B) June 1, 2023, or (C) the termination of the License Agreement.
Under the terms of the Loan Agreement, the Company received an initial tranche of $20.0 million from the Lenders on the closing date. The second tranche of the Term Loan, consisting of up to an additional $10.0 million, became available to the Company upon receipt of approval from the FDA of ibrexafungerp for the treatment of vaginal yeast infections (the “First Performance Milestone”) and was fully funded in June 2021. The third tranche of the Term Loan, consisting of an additional
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$5.0 million, became available to the Company upon (a) the First Performance Milestone and (b) the achievement of the primary endpoint from the Phase 3 study of ibrexafungerp in patients with recurrent vulvovaginal candidiasis, and was fully funded in March 2022. The fourth tranche of the Term Loan, consisting of up to an additional $25.0 million, will be available to the Company from January 1, 2022 through December 31, 2023 in $5.0 million increments, subject to certain terms and conditions, including in maintaining a ratio of total outstanding Term Loan principal to net product revenues for BREXAFEMME below a certain specified level for a given draw period.
The Company estimated the fair value of the loan payable as of March 31, 2023 using a credit spread valuation model and Level 3 inputs which included an implied secured spread, risk free rate, and secured yield of 9.48%, 4.80%, and 14.28%, respectively. As of December 31, 2022, the implied secured spread, risk free rate, and secured yield were 9.84%, 4.37%, and 14.21%. At March 31, 2023 and December 31, 2022, the fair value of the loan payable is $36.6 million and $34.4 million, respectively.
The Term Loan bears interest at a variable annual rate equal to the greater of (a) 9.05% and (b) the Prime Rate (as reported in the Wall Street Journal) plus 5.80% (the “Interest Rate”). The Company is currently making payments of interest only.
The Loan Agreement contains customary closing fees, prepayment fees and provisions, events of default, and representations, warranties and covenants, including a financial covenant requiring the Company to maintain certain levels of trailing three-month net product revenue solely from the sale of ibrexafungerp commencing on September 30, 2022. The financial covenant will be waived at any time in which the Company maintains unrestricted and unencumbered cash in accounts maintained with SVB and another financial institution equal to at least 50.0% of the total outstanding Term Loan principal amount, subject to certain requirements.
Future principal debt payments on the currently outstanding loan payable as of March 31, 2023 are as follows (in thousands):
| | | | |
2023 | | $ | 35,000 | |
Total principal payments | | | 35,000 | |
Final fee due at maturity | | | 1,383 | |
Total principal and final fee payment | | | 36,383 | |
Unamortized discount and debt issuance costs | | | (1,735 | ) |
Loan payable, current portion | | $ | 34,648 | |
March 2019 Note Purchase Agreement
On March 7, 2019, the Company entered into a Senior Convertible Note Purchase Agreement (the “March 2019 Note Purchase Agreement”) with Puissance. Pursuant to the March 2019 Note Purchase Agreement, on March 7, 2019, the Company issued and sold to Puissance $16.0 million aggregate principal amount of its 6.0% Senior Convertible Notes due 2025 (“March 2019 Notes”), resulting in $14.7 million in net proceeds after deducting $1.3 million for an advisory fee and other issuance costs.
As of March 31, 2023 and December 31, 2022, the Company’s March 2019 Notes consists of the convertible debt balance of $11.0 million and the bifurcated embedded conversion option derivative liability of $0.4 million and $42,000, respectively. In connection with the Company’s issuance of its March 2019 Notes, the Company bifurcated the embedded conversion option, inclusive of the interest make-whole provision and make-whole fundamental change provision, and recorded the embedded conversion option as a long-term derivative liability in the Company’s balance sheet in accordance with ASC 815, Derivatives and Hedging, at its initial fair value of $7.0 million as the interest make-whole provision is settled in shares of common stock. The convertible debt and derivative liability associated with the March 2019 Notes are presented in total on the accompanying unaudited condensed consolidated balance sheets as the convertible debt and derivative liability. The derivative liability will be remeasured at each reporting period using the binomial lattice model with changes in fair value recorded in the statements of operations in other (income) expense. For the three months ended March 31, 2023 and 2022, the Company recognized a loss of $0.4 million and a gain of $1.0 million, respectively, on the fair value adjustment for the derivative liability. For the three months ended March 31, 2023 and 2022, the Company recognized zero and $0.2 million in amortization of debt issuance costs and discount related to the March 2019 Notes.
The Company estimated the fair value of the convertible debt and derivative liability for the March 2019 Notes using a binomial lattice valuation model and Level 3 inputs. At March 31, 2023 and December 31, 2022, the fair value of the convertible debt and derivative liability for the March 2019 Notes is $11.7 million and $10.8 million, respectively.
The March 2019 Notes bear interest at a rate of 6.0% per annum payable semiannually in arrears on March 15 and September 15 of each year, beginning September 15, 2019. The March 2019 Notes will mature on March 15, 2025, unless earlier converted, redeemed or repurchased. The March 2019 Notes constitute general, senior unsecured obligations of the Company.
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Other Liabilities
In February 2021, the Company partnered with Amplity for the commercial launch of BREXAFEMME for the treatment of VVC. Under the terms of the agreement with Amplity, the Company was to utilize Amplity’s commercial execution and resources for sales force, remote engagement, training, market access and select operations services. In October 2022, the Company announced that it was actively pursuing a U.S. commercialization partner to out-license BREXAFEMME in order to refocus the Company's resources on the further clinical development of ibrexafungerp for severe, hospital-based indications. As a result, the Company wound down its promotional activities associated with BREXAFEMME, while keeping BREXAFEMME on the market and available to patients. On November 30, 2022, the Company terminated the agreement with Amplity. Under the terms of the original agreement, Amplity deferred a portion of its direct service fees in the first two years (2021 and 2022) that accrued interest at an annual rate of 12.75% (“Deferred Fees”). The Deferred Fees of $5.8 million as of December 31, 2022 were fully paid as of February 2023.
8. Commitments and Contingencies
Leases
On March 1, 2018, the Company entered into a long-term lease agreement for approximately 19,275 square feet of office space in Jersey City, New Jersey, that the Company identified as an operating lease under ASC 842 (the “Lease”). The lease term is eleven years from August 1, 2018, the commencement date, with total lease payments of $7.3 million over the lease term. The Company has the option to renew for two consecutive five-year periods from the end of the first term and the Company is not reasonably certain that the option to renew the Lease will be exercised. Under the Lease, the Company furnished a security deposit in the form of a standby letter of credit in the amount of $0.3 million, which was reduced by fifty-five thousand dollars on the first anniversary of the commencement date. The security deposit will continue to be reduced by fifty-five thousand dollars every two years on the commencement date anniversary for eight years. The security deposit is classified as restricted cash in the accompanying unaudited condensed consolidated balance sheets.
The following table summarizes certain quantitative information associated with the amounts recognized in the unaudited condensed consolidated financial statements for the Lease (dollars in thousands):
| | | | | | | | |
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Operating lease cost | | $ | 166 | | | $ | 166 | |
Variable lease cost | | | 58 | | | | (3 | ) |
Total operating lease expense | | $ | 224 | | | $ | 163 | |
| | | | | | |
Cash paid for amounts included in the measurement of operating lease liability | | $ | 177 | | | $ | 174 | |
| | | | | | |
| | March 31, 2023 | | | December 31, 2022 | |
Remaining Lease term (years) | | | 6.34 | | | | 6.59 | |
Discount rate | | | 15 | % | | | 15 | % |
Future minimum lease payments for the Lease as of March 31, 2023 are as follows (in thousands):
| | | | |
| | March 31, 2023 | |
2023 | | $ | 538 | |
2024 | | | 730 | |
2025 | | | 744 | |
2026 | | | 759 | |
2027 | | | 774 | |
Thereafter | | | 1,256 | |
Total | | $ | 4,801 | |
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The presentations of the operating lease liability as of March 31, 2023 are as follows (in thousands):
| | | | |
| | March 31, 2023 | |
Present value of future minimum lease payments | | $ | 3,138 | |
| | | |
Operating lease liability, current portion | | $ | 296 | |
Operating lease liability, long-term portion | | | 2,842 | |
Total operating lease liability | | $ | 3,138 | |
| | | |
Difference between future minimum lease payments and discounted cash flows | | $ | 1,663 | |
License Arrangement with Potential Future Expenditures
As of March 31, 2023, the Company had a license arrangement with Merck Sharp & Dohme Corp., or Merck, as amended, that involves potential future expenditures. Under the license arrangement, executed in May 2013, the Company exclusively licensed from Merck its rights to ibrexafungerp in the field of human health. In January 2014, Merck assigned the patents related to ibrexafungerp that it had exclusively licensed to the Company. Ibrexafungerp is the Company's lead product candidate. Pursuant to the terms of the license agreement, Merck was originally eligible to receive milestone payments from the Company that could total $19.0 million upon occurrence of specific events, including initiation of a Phase 2 clinical study, new drug application, and marketing approvals in each of the U.S., major European markets, and Japan. In addition, Merck is eligible to receive tiered royalties from the Company based on a percentage of worldwide net sales of ibrexafungerp. The aggregate royalties are mid- to high-single digits.
In December 2014, the Company and Merck entered into an amendment to the license agreement that deferred the remittance of a milestone payment due to Merck, such that no amount would be due upon initiation of the first Phase 2 clinical trial of a product containing the ibrexafungerp compound (the “Deferred Milestone”). The amendment also increased, in an amount equal to the Deferred Milestone, the milestone payment that would be due upon initiation of the first Phase 3 clinical trial of a product containing the ibrexafungerp compound. In December 2016 and January 2018, the Company entered into second and third amendments to the license agreement with Merck which clarified what would constitute the initiation of a Phase 3 clinical trial for the purpose of milestone payment. In January 2019, a milestone payment became due to Merck as a result of the initiation of the VANISH Phase 3 VVC program and was paid in March 2019. On December 2, 2020, the Company entered into a fourth amendment to the license agreement with Merck. The amendment eliminates two cash milestone payments that the Company would have paid to Merck upon the first filing of an NDA, triggered by the FDA acceptance for filing of the Company’s NDA for ibrexafungerp for the treatment of VVC, and first marketing approval in the U.S. Such cash milestone payments would have been creditable against future royalties owed to Merck on net sales of ibrexafungerp. With the amendment, these milestones will not be paid in cash and, accordingly, credits will not accrue. Pursuant to the amendment, the Company will also forfeit the credits against future royalties that it had accrued from a prior milestone payment already paid to Merck. All other key terms of the license agreement are unchanged.
9. Stockholders’ Equity
Authorized, Issued, and Outstanding Common Stock
The Company’s authorized common stock has a par value of $0.001 per share and consists of 150,000,000 shares as of March 31, 2023, and December 31, 2022; 33,327,627 and 32,682,342 shares were issued and outstanding at March 31, 2023, and December 31, 2022, respectively. In January 2023 and April 2023, 363,000 and 3,189,815 of the prefunded warrants from the April 2022 public offering were exercised for total proceeds of $3,553.
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The following table summarizes common stock share activity for the three months ended March 31, 2023 and 2022 (dollars in thousands):
| | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, 2023 | |
| | Shares of
Common Stock | | | Common
Stock | | | Additional
Paid-in
Capital | | | Accumulated
Deficit | | | Total
Stockholders’
(Deficit) Equity | |
Balance, December 31, 2022 | | | 32,682,342 | | | $ | 36 | | | $ | 425,485 | | | $ | (422,288 | ) | | $ | 3,233 | |
Net loss | | | — | | | | — | | | | — | | | | (33,876 | ) | | | (33,876 | ) |
Stock-based compensation expense | | | — | | | | — | | | | 707 | | | | — | | | | 707 | |
Common stock issued through employee stock purchase plan | | | 2,662 | | | | — | | | | 4 | | | | — | | | | 4 | |
Common stock issued, net of expenses | | | 363,000 | | | | — | | | | — | | | | — | | | | — | |
Common stock issued for vested restricted stock units | | | 279,623 | | | | — | | | | 18 | | | | — | | | | 18 | |
Balance, March 31, 2023 | | | 33,327,627 | | | $ | 36 | | | $ | 426,214 | | | $ | (456,164 | ) | | $ | (29,914 | ) |
| | | | | | | | | | | | | | | |
| | Three Months Ended March 31, 2022 | |
| | Shares of
Common Stock | | | Common
Stock | | | Additional
Paid-in
Capital | | | Accumulated
Deficit | | | Total
Stockholders’
Equity | |
Balance, December 31, 2021 | | | 28,705,334 | | | $ | 32 | | | $ | 400,705 | | | $ | (359,479 | ) | | $ | 41,258 | |
Net loss | | | — | | | | — | | | | — | | | | (5,451 | ) | | | (5,451 | ) |
Stock-based compensation expense | | | — | | | | — | | | | 922 | | | | — | | | | 922 | |
Common stock issued, net of expenses | | | 487,610 | | | | — | | | | 2,135 | | | | — | | | | 2,135 | |
Common stock issued through employee stock purchase plan | | | 3,120 | | | | — | | | | 10 | | | | — | | | | 10 | |
Common stock issued for vested restricted stock units | | | 25,094 | | | | — | | | | (18 | ) | | | — | | | | (18 | ) |
Vested Loan Agreement warrants | | | — | | | | — | | | | 71 | | | | — | | | | 71 | |
Balance, March 31, 2022 | | | 29,221,158 | | | $ | 32 | | | $ | 403,825 | | | $ | (364,930 | ) | | $ | 38,927 | |
| | | | | | | | | | | | | | | |
Shares Reserved for Future Issuance
The Company had reserved shares of common stock for future issuance as follows:
| | | | | | | | |
| | March 31, 2023 | | | December 31, 2022 | |
Outstanding stock options | | | 1,931,389 | | | | 1,740,308 | |
Outstanding restricted stock units | | | 2,214,490 | | | | 633,270 | |
Warrants to purchase common stock associated with March 2018 public offering – Series 2 | | | — | | | | 798,810 | |
Warrants to purchase common stock associated with December 2020 public offering - Series 2 | | | 6,800,000 | | | | 6,800,000 | |
Prefunded warrants to purchase common stock associated with December 2020 public offering | | | 3,200,000 | | | | 3,200,000 | |
Warrants to purchase common stock associated with April 2022 Public Offering | | | 15,000,000 | | | | 15,000,000 | |
Prefunded warrants to purchase common stock associated with April 2022 Public Offering | | | 11,303,667 | | | | 11,666,667 | |
Warrants to purchase common stock associated with Loan Agreement | | | 198,811 | | | | 198,811 | |
Warrant to purchase common stock associated with Danforth | | | 50,000 | | | | 50,000 | |
For possible future issuance for the conversion of the March 2019 Notes | | | 1,138,200 | | | | 1,138,200 | |
For possible future issuance under 2014 Plan (Note 10) | | | 590,207 | | | | 712,020 | |
For possible future issuance under employee stock purchase plan | | | 279 | | | | — | |
For possible future issuance under 2015 Plan (Note 10) | | | 566,413 | | | | 550,964 | |
Total common shares reserved for future issuance | | | 42,993,456 | | | | 42,489,050 | |
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Common Stock Purchase Agreement and Sales Agreements
On April 10, 2020, the Company entered into the Common Stock Purchase Agreement with Aspire Capital (the “Common Stock Purchase Agreement”) pursuant to which the Company had the right to sell to Aspire Capital from time to time in its sole discretion up to $20.0 million in shares of the Company’s common stock, subject to certain limitations and conditions set forth in the Common Stock Purchase Agreement. The Common Stock Purchase Agreement expired in October 2022. During the three months ended March 31, 2022, the Company sold 350,000 shares of its common stock under the Common Stock Purchase Agreement for gross proceeds of $1.5 million.
During the three months ended March 31, 2023 and 2022, the Company sold zero and 137,610 shares of its common stock and received net proceeds of zero and $0.7 million, respectively, under the Controlled Equity OfferingSM Sales Agreements with Cantor Fitzgerald & Co. and Ladenburg Thalmann & Co. Inc. (the “Sales Agreements”).
Warrants Associated with the March 2018, December 2020, and April 2022 Public Offerings
The outstanding warrants associated with the March 2018 and December 2020 public offerings contain a provision where the warrant holder has the option to receive cash, equal to the Black-Scholes fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity, requires that these warrants be classified as liabilities. The fair values of these 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. During the three months ended March 31, 2023 and 2022, the Company recognized a loss of $21.7 million and a gain of $10.0 million on the warrant liabilities fair value adjustment, respectively. As of March 31, 2023 and December 31, 2022, the fair value of the warrant liabilities was $40.3 million and $18.6 million, respectively.
10. Stock-based Compensation
Pursuant to the terms of the Company’s 2014 Equity Incentive Plan (“2014 Plan”), on January 1, 2023 and 2022, the Company automatically added 1,901,960 and 1,148,213 shares to the total number shares of common stock available for future issuance under the 2014 Plan, respectively. As of March 31, 2023, there were 590,207 shares of common stock available for future issuance under the 2014 Plan.
As of March 31, 2023, there were 566,413 shares of common stock available for future issuance under the Company’s 2015 Inducement Award Plan (“2015 Plan”). During the three months ended March 31, 2023 and 2022, there were options to purchase zero and 69,000 shares of the Company’s common stock granted under the 2015 Plan, respectively.
The activity for the Company’s 2009 Stock Option Plan, 2014 Plan, and 2015 Plan, for the three months ended March 31, 2023, is summarized as follows:
| | | | | | | | | | | | | | | | |
| | Number of
Shares | | | Weighted-
Average
Exercise
Price | | | Weighted-
Average
Remaining
Contractual
Life (in years) | | | Aggregate
Intrinsic
Value ($000) | |
Outstanding — December 31, 2022 | | | 1,740,308 | | | $ | 12.21 | | | | 6.16 | | | $ | — | |
Granted | | | 225,000 | | | $ | 1.54 | | | | | | | |
Forfeited/Cancelled | | | (33,919 | ) | | $ | 7.35 | | | | | | | |
Outstanding — March 31, 2023 | | | 1,931,389 | | | $ | 11.05 | | | | 6.45 | | | $ | 544 | |
Exercisable — March 31, 2023 | | | 1,202,326 | | | $ | 15.70 | | | | 4.82 | | | $ | 10 | |
Vested or expected to vest — March 31, 2023 | | | 1,931,389 | | | $ | 11.05 | | | | 6.45 | | | $ | 544 | |
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Restricted stock unit (“RSU”) activity under the 2014 Plan and 2015 Plan for the three months ended March 31, 2023, is summarized as follows:
| | | | | | | | |
| | Number of
Shares | | | Weighted
Average
Grant Date
Fair Value
Per Share | |
Non-vested at December 31, 2022 | | | 633,270 | | | $ | 5.29 | |
Granted | | | 1,819,575 | | | $ | 1.73 | |
Vested | | | (236,023 | ) | | $ | 5.87 | |
Forfeited | | | (2,332 | ) | | $ | 5.13 | |
Non-vested at March 31, 2023 | | | 2,214,490 | | | $ | 2.30 | |
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 25% annually over a four-year period from the date of grant. Upon vesting, the RSUs generally are net share settled to cover the required withholding tax with the remaining shares issued to the holder. The Company recognizes compensation expense for such awards ratably over the corresponding vesting period.
Compensation Cost
The compensation cost that has been charged against income for stock awards under the 2014 Plan and the 2015 Plan was $0.7 million and $0.9 million for the three months ended March 31, 2023 and 2022, respectively. The total income tax benefit recognized in the statements of operations for share-based compensation arrangements was zero for each of the three months ended March 31, 2023 and 2022.
Stock-based compensation expense related to stock options is included in the following line items in the accompanying unaudited condensed consolidated statements of operations (in thousands):
| | | | | | | | |
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Research and development | | $ | 374 | | | $ | 285 | |
Selling, general and administrative | | | 333 | | | | 637 | |
Total | | $ | 707 | | | $ | 922 | |
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11. Fair Value Measurements
The carrying amounts of certain financial instruments, including cash and cash equivalents, restricted cash, 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. The following table summarizes the conclusions reached as of March 31, 2023 and December 31, 2022 for financial instruments measured at fair value on a recurring basis (in thousands):
| | | | | | | | | | | | | | | | |
| | | | | Fair Value Hierarchy Classification | |
| | Balance | | | Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1) | | | Significant
Other
Observable
Inputs
(Level 2) | | | Significant
Unobservable
Inputs (Level 3) | |
March 31, 2023 | | | | | | | | | | | | |
Cash | | $ | 563 | | | $ | 563 | | | | — | | | | — | |
Restricted cash | | | 218 | | | | 218 | | | | — | | | | — | |
Money market funds | | | 26,350 | | | | 26,350 | | | | — | | | | — | |
Total assets | | $ | 27,131 | | | $ | 27,131 | | | | — | | | | — | |
| | | | | | | | | | | | |
Warrant liabilities | | $ | 40,317 | | | | — | | | | — | | | $ | 40,317 | |
Derivative liability | | | 448 | | | | — | | | | — | | | | 448 | |
Total liabilities | | $ | 40,765 | | | | — | | | | — | | | $ | 40,765 | |
| | | | | | | | | | | | |
December 31, 2022 | | | | | | | | | | | | |
Cash | | $ | 415 | | | $ | 415 | | | | — | | | | — | |
Restricted cash | | | 218 | | | | 218 | | | | — | | | | — | |
Money market funds | | | 45,399 | | | | 45,399 | | | | — | | | | — | |
Total assets | | $ | 46,032 | | | $ | 46,032 | | | | — | | | | — | |
| | | | | | | | | | | | |
Warrant liabilities | | $ | 18,644 | | | | — | | | | — | | | $ | 18,644 | |
Derivative liability | | | 42 | | | | — | | | | — | | | | 42 | |
Total liabilities | | $ | 18,686 | | | | — | | | | — | | | $ | 18,686 | |
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.
Level 3 financial liabilities consist of the warrant liabilities 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 liabilities 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 liabilities 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 March 31, 2023, the range and weighted average of the Level 3 volatilities utilized in the Black-Scholes model to fair value the warrant liabilities were 100.8% to 111.9% and 102.1%, respectively.
The Company uses the binomial lattice valuation model to value the Level 3 derivative liabilities at inception and on subsequent valuation dates. This model incorporates transaction details such as the Company’s stock price, contractual terms, dividend yield, risk-free rate, adjusted equity volatility, credit rating, market credit spread, and estimated effective yield. The unobservable inputs associated with the Level 3 derivative liabilities are adjusted equity volatility, market credit spread, and estimated yield. As of March 31, 2023, these inputs were 82.3%, 1,454 basis points, and 18.6%, respectively. The senior convertible notes are initially fair valued using the binomial lattice model and with the straight debt fair value calculated using
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the discounted cash flow method. The residual difference represents the fair value of the embedded derivative liabilities and the fair value of the embedded derivative liabilities are reassessed using the binomial lattice valuation model on a quarterly basis.
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, 2022 | | | $ | 18,644 | |
Loss adjustment to fair value | | | | 21,673 | |
Balance – March 31, 2023 | | | $ | 40,317 | |
| | | | |
| | | Derivative Liability | |
Balance – December 31, 2022 | | | $ | 42 | |
Loss adjustment to fair value | | | | 406 | |
Balance – March 31, 2023 | | | $ | 448 | |
12. Revenue
Product Revenue, Net
Net product revenue was $1.1 million and $0.7 million for the three months ended March 31, 2023 and 2022, respectively. Products are sold primarily to wholesalers and specialty pharmacies. Revenue is reduced from wholesaler list price at the time of recognition for expected chargebacks, rebates, discounts, incentives, and returns, which are referred to as gross to net (“GTN”) adjustments. These reductions are currently attributed to various commercial arrangements. Chargebacks and discounts are recognized as a reduction in accounts receivable or as accrued expenses based on their nature and settled through the issuance of credits to the customer or through cash payments to the customer, respectively. All other returns, rebates, and incentives are reflected as accrued expenses and settled through cash payments to the customer. Revenue attributed to sales to three wholesalers comprised 46%, 26%, and 25% of the Company’s gross revenue for the three months ended March 31, 2023.
The following table summarizes activity in each of the Company’s product revenue provision and allowance categories as of March 31, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | |
| | Discounts and Chargebacks (1) | | | Product Returns (2) | | | Rebates and Incentives (3) | | | Total | |
Balance as of December 31, 2022 | | $ | 255 | | | $ | 73 | | | $ | 1,213 | | | $ | 1,541 | |
Provision related to current period revenue | | | 392 | | | | 12 | | | | 943 | | | | 1,347 | |
Changes in estimate related to prior period revenue | | | — | | | | — | | | | — | | | | — | |
Credit/payments | | | (324 | ) | | | (2 | ) | | | (699 | ) | | | (1,025 | ) |
Balance as of March 31, 2023 | | $ | 323 | | | $ | 83 | | | $ | 1,457 | | | $ | 1,863 | |
| | | | | | | | | | | | |
| | Discounts and Chargebacks (1) | | | Product Returns (2) | | | Rebates and Incentives (3) | | | Total | |
Balance as of December 31, 2021 | | $ | 249 | | | $ | 21 | | | $ | 1,110 | | | $ | 1,380 | |
Provision related to current period revenue | | | 272 | | | | 10 | | | | 1,092 | | | | 1,374 | |
Changes in estimate related to prior period revenue | | | — | | | | — | | | | — | | | | — | |
Credit/payments | | | (122 | ) | | | — | | | | (1,040 | ) | | | (1,162 | ) |
Balance as of March 31, 2022 | | $ | 399 | | | $ | 31 | | | $ | 1,162 | | | $ | 1,592 | |
| |
(1) | Discounts and chargebacks include fees for wholesaler fees, prompt pay and other discounts, and chargebacks. Discounts and chargebacks are deducted from gross revenue at the time revenues are recognized and are included as a reduction in accounts receivable or as an accrued expense based on their nature on the Company’s unaudited condensed consolidated balance sheet. |
(2) | Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses on the Company’s unaudited condensed consolidated balance sheet. |
(3) | Rebates and incentives include rebates and co-pay program incentives. Provisions for rebates and incentives are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses on the Company’s unaudited condensed consolidated balance sheets. |
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License Agreement with GSK
On March 30, 2023, the Company entered into a License Agreement with GSK. Pursuant to the terms of the License Agreement, the Company granted GSK an exclusive (even as to the Company and its affiliates), royalty-bearing, sublicensable license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in all countries other than Greater China and certain other countries already licensed to third parties (the “GSK Territory”). If the existing licenses granted to or agreements with third parties are terminated with respect to any country, GSK will have an exclusive first right to negotiate with the Company to add those additional countries to the GSK Territory.
The consummation of the transactions under the License Agreement is subject to the satisfaction of customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act”); provided, that either the Company or GSK may terminate the License Agreement if expiration or termination of the applicable waiting period under the HSR Act has not occurred within nine months of the signing of the License Agreement. The parties expect the transactions contemplated by the License Agreement to close in the second quarter of 2023.
The Company retains rights to all other assets, with GSK receiving a right of first negotiation (“ROFN”) to any other enfumafungin-derived compounds or products that the Company may control.
Under the terms of the License Agreement, the Company will receive an upfront payment of $90 million. The Company is also eligible to receive potential:
•regulatory approval milestone payments of up to $70 million;
•commercial milestone payments of up to $115 million based on first commercial sale in invasive candidiasis (U.S./EU);
•and sales milestone payments of up to $242.5 million based on annual net sales, with a total of $77.5 million to be paid upon achievement of multiple thresholds up through $200 million; a total of $65 million to be paid upon achievement of multiple thresholds between $300 million and $500 million; and $50 million to be paid at each threshold of $750 million and $1 billion.
The Company will be responsible for the execution and costs of the ongoing clinical studies of ibrexafungerp but will have the potential to receive up to $75.5 million in success-based development milestones, which are comprised of up to $65 million for the achievement of three interim milestones associated with the Company's continued performance of the ongoing MARIO Study and $10.5 million for the successful completion of the MARIO Study.
In the case of each of the above milestones, such milestone events are defined in the License Agreement.
GSK will also pay royalties based on cumulative annual sales to the Company in the mid-single digit to mid-teen range. These royalty rates are subject to reduction, including in the event of third-party licenses, entry of a generic product, or the expiration of licensed patents.
A joint development committee will be established between GSK and the Company to coordinate and review ongoing development activities of ibrexafungerp.
Unless earlier terminated, the License Agreement will expire on a product-by-product and country-by-country basis at the end of the royalty term for such product in such country.
The Company has the right to terminate the License Agreement upon an uncured material breach by, or bankruptcy of, GSK. GSK has the right to terminate the License Agreement at any time for convenience in its entirety or on a product-by-product and country-by-country basis, upon an uncured material breach by, or bankruptcy of, the Company, or for safety reasons.
License Agreement with Hansoh
In February 2021, the Company entered into an Exclusive License and Collaboration Agreement (the “Agreement”) with Hansoh (Shanghai) Health Technology Co., Ltd., and Jiangsu Hansoh Pharmaceutical Group Company Limited (collectively, “Hansoh”), pursuant to which the Company granted to Hansoh an exclusive license to research, develop and commercialize ibrexafungerp in the Greater China region, including mainland China, Hong Kong, Macau, and Taiwan (the “Territory”). The Company also granted to Hansoh a non-exclusive license to manufacture ibrexafungerp solely for development and commercialization in the Territory. For the three months ended March 31, 2023 and 2022, there was no license agreement revenue recognized associated with the Agreement given the variable consideration was fully constrained as of March 31, 2023 and 2022, respectively.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Operating results for the three months ended March 31, 2023, 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,” “anticipate,” “target,” “goal,” “intend,” “plan,” “seek,” “estimate,” “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 31, 2023, 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 lead product candidate, ibrexafungerp, as a broad-spectrum, intravenous (IV)/oral agent for severe, hospital-based indications. In June 2021 and December 2022, we announced that the U.S. Food and Drug Administration (FDA) approved BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection, and for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC), respectively.
Ibrexafungerp, the first representative of a novel class of antifungal agents called triterpenoids, is a structurally distinct glucan synthase inhibitor and has shown in vitro and in vivo activity against a broad range of human fungal pathogens such as Candida and Aspergillusgenera, including multidrug-resistant strains, as well as Pneumocystis, Coccidioides, Histoplasma and Blastomyces genera. Candida and Aspergillus genera are the fungi responsible for approximately 85% of all invasive fungal infections in the United States (U.S.) and Europe. To date, we have characterized the antifungal activity, pharmacokinetics, and safety profile of the oral and IV formulations of ibrexafungerp in multiple in vitro, in vivo, and clinical studies. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to ibrexafungerp for the indications of VVC (including the prevention of recurrent VVC), invasive candidiasis (IC) (including candidemia), and invasive aspergillosis (IA), and has granted Orphan Drug designations for the IC and IA indications. The European Medicines Agency has granted Orphan Medicinal Product designation to ibrexafungerp for IC. These designations may provide us with additional market exclusivity and expedited regulatory paths.
On March 30, 2023, we entered into a license agreement (the License Agreement) with GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK). Pursuant to the terms of the License Agreement, we granted GSK an exclusive (even as to us and our affiliates), royalty-bearing, sublicensable license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in all countries other than Greater China and certain other countries already licensed to third parties (the GSK Territory). If the existing licenses granted to or agreements with third parties are terminated with respect to any country, GSK will have an exclusive first right to negotiate with us to add those additional countries to the GSK Territory. We retain rights to all other assets, with GSK receiving a right of first negotiation (ROFN) to any other enfumafungin-derived compounds or products that we may control. The consummation of the transactions under the License Agreement is subject to the satisfaction of customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act); provided, that either we or GSK may terminate the License Agreement if expiration or termination of the applicable waiting period under the HSR Act has not occurred within nine months of the signing of the License Agreement. The parties expect the transactions contemplated by the License Agreement to close in the second quarter of 2023.
Under the terms of the License Agreement, we will receive an upfront payment of $90 million. We are also eligible to receive potential:
•regulatory approval milestone payments of up to $70 million;
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•commercial milestone payments of up to $115 million based on first commercial sale in invasive candidiasis (U.S./EU);
•and sales milestone payments of up to $242.5 million based on annual net sales, with a total of $77.5 million to be paid upon achievement of multiple thresholds up through $200 million; a total of $65 million to be paid upon achievement of multiple thresholds between $300 million and $500 million; and $50 million to be paid at each threshold of $750 million and $1 billion.
We will be responsible for the execution and costs of the ongoing clinical studies of ibrexafungerp but will have the potential to receive up to $75.5 million in success-based development milestones, which are comprised of up to $65 million for the achievement of three interim milestones associated with our continued performance of the ongoing MARIO Study and $10.5 million for the successful completion of the MARIO Study. See further details of the License Agreement, including financial terms, as described in Note 12 of Item 1 on this Quarterly Report.
We, Hercules Capital, Inc. (Hercules Capital) and Silicon Valley Bridge Bank, N.A. (now a division of First Citizens Bank, SVB) are party to a Loan and Security Agreement dated as of May 13, 2021 (the Loan Agreement), pursuant to which Hercules Capital, SVB and each of the other lenders from time-to-time party to the Loan and Security Agreement (collectively, the Lenders) loaned to us $35 million. In connection with the entering into of the License Agreement, we entered into a First Amendment and Consent to Loan and Security Agreement with the Lenders pursuant to which the Lenders consented to us entering into the License Agreement and we agreed to pay to the Lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement (approximately $35.4 million), (ii) the prepayment fee payable under Loan Agreement ($262,500), (iii) the final payment payable under Loan Agreement ($1,382,500), and (iv) all other sums, if any, that shall have become due and payable with respect to loan advances under the Loan Agreement. These payments by us will become due upon the earliest of (A) one business day following receipt by us of the $90 million upfront payment payable to us under the License Agreement, (B) June 1, 2023, or (C) the termination of the License Agreement.
Ibrexafungerp Update
Enrollment is continuing in our prospective, randomized, double-blind, global Phase 3 study to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a step-down therapy for patients with IC including candidemia following IV echinocandin therapy in the hospital compared to currently available therapies (the MARIO study). Eligible patients with IC will receive treatment with IV echinocandin and will then be switched to either oral ibrexafungerp or a standard of care option, either oral fluconazole or best available therapy for subjects with infections caused by fluconazole non-susceptible strains, once step-down criteria are met. Approximately 220 patients will be enrolled and randomized in the study, and we expect topline results in the first half of 2024 and a potential approval by the end of 2024.
We achieved a target enrollment of 200 patients in our Phase 3 FURI study investigating the potential of ibrexafungerp as a treatment for fungal infections that are refractory or intolerant to other antifungals, including infections caused by Candida auris (C. auris), and anticipate study completion activities in the first half of 2023 with a Data Review Committee review and topline data in the first half of 2024. We also achieved a target enrollment of 30 patients in our Phase 3 CARES study, focused on patients with infections caused by C. auris which will follow similar completion and reporting timing to the Phase 3 FURI study. The data from the MARIO study along with data from FURI and CARES studies are intended to be supportive of an NDA submission in 2024 with an anticipated first approval for an indication in the hospital setting later in 2024. If the License Agreement closes, such NDA submission would be made by GSK and any resulting approval would be held by GSK.
We have completed the enrollment of SCYNERGIA, our Phase 2 study of oral ibrexafungerp in combination with voriconazole in patients with IA, although the number of patients is smaller than initially projected. The prioritization of hospital resources toward addressing COVID-19 has impacted the ability of many institutions to focus on screening and enrolling patients into some clinical trials, including SCYNERGIA.
We have completed the enrollment of the VANQUISH Phase 3b open-label trial evaluating the safety and efficacy of ibrexafungerp in patients with complicated vulvovaginal candidiasis who failed to respond to treatment with fluconazole.
Liquidity
We have operated as a public entity since we completed our initial public offering in May 2014, which we refer to as our IPO. We also completed a follow-on public offering of our common stock in April 2015 and public offerings of our common stock and warrants in June 2016, March 2018, December 2019, December 2020, and April 2022. Our principal source of liquidity is cash, cash equivalents, and short-term investments which totaled $54.8 million as of March 31, 2023 and we have the availability to issue up to $46.2 million of our common stock under our at-the-market facility with Cantor Fitzgerald & Co. (Cantor) and Ladenburg Thalmann & Co. Inc. (Ladenburg). We received $30.0 million in 2021 and received $5.0 million in 2022 under our Loan Agreement with Hercules and SVB. In March 2023, in connection with the entering into of the License
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Agreement with GSK, we, Hercules and SVB entered into a First Amendment and Consent to Loan and Security Agreement pursuant to which the lenders under the Loan Agreement consented to us entering into the License Agreement and we agreed to pay to the lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement (approximately $35.4 million), (ii) the prepayment fee payable under Loan Agreement ($262,500), (iii) the final payment payable under Loan Agreement ($1,382,500), and (iv) all other sums, if any, that shall have become due and payable with respect to loan advances under the Loan Agreement. These payments by us will become due upon the earliest of (A) one business day following receipt by us of the $90 million upfront payment payable to us under the License Agreement, (B) June 1, 2023, or (C) the termination of the License Agreement. See “Liquidity and Capital Resources” below for amounts sold under the ATM with Cantor and Ladenburg, and the amounts sold under our common stock purchase agreement with Aspire Capital which expired in October 2022.
We have incurred net losses since our inception, including the year ended December 31, 2022. As of March 31, 2023, our accumulated deficit was $456.2 million. We expect we will continue to incur significant research and development expense as we continue to execute our research and drug development strategy. Consistent with our operating plan, we also expect that we will continue to incur significant selling, general and administrative expenses to support our public reporting company operations and ongoing operations, but that our selling, general and administrative expenses will decrease as we have ceased the active promotional activities associated with BREXAFEMME. As a result, 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, including under our ATM.
Collaborations and Licensing Agreements
We are party to a number of licensing and collaboration agreements with partners in human health, including: (1) Merck, a pharmaceutical company, under which we exclusively licensed the rights to ibrexafungerp in the field of human health, and agreed to pay Merck milestones upon the occurrence of specified events as well as tiered royalties based on worldwide sales of ibrexafungerp when and if it is approved (in 2014, Merck assigned to us the patents related to ibrexafungerp that it had exclusively licensed to us and, as contemplated by the agreement, we will continue to pay milestones and royalties); (2) Hansoh, a pharmaceutical company, which we exclusively provide a license from us to research, develop and commercialize ibrexafungerp in the Greater China region, including mainland China, Hong Kong, Macau, and Taiwan, under which we are entitled to receive development and commercial milestones and royalties (3) R-Pharm, CJSC, or "R-Pharm," a leading supplier of hospital drugs in Russia, granting it exclusive rights in the field of human health to develop and commercialize ibrexafungerp in Russia and several non-core markets, under which we are entitled to receive potential milestones and royalties and reimbursement for certain development costs incurred by us (this agreement is not material to our unaudited condensed consolidated balance sheets, statements of operations, or statements of cash flows); (4) Waterstone, an international pharmaceutical business, granting Waterstone exclusive worldwide rights to development and commercialization of SCY-635 for the treatment of viral diseases in humans, under which we are entitled to receive potential milestones and royalties; and (5) Cypralis Limited, or "Cypralis," a life sciences company, transferring to it certain cyclophilin inhibitor assets of ours, under which we are eligible to receive milestone payments upon the successful progression of certain Cypralis clinical candidates into later stage clinical studies and royalties payable upon product commercialization.
Components of Operating Results
Revenue
Revenue consists of product sales of BREXAFEMME.
Cost of Product Revenue
Cost of product revenue consists primarily of distribution, freight expenses, royalties due to Merck, and other manufacturing costs associated with BREXAFEMME. Prior to the regulatory approval of BREXAFEMME on June 1, 2021, we expensed as research and development the costs associated with the third-party manufacture of BREXAFEMME.
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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:
•costs related to executing preclinical and clinical trials, including development milestones, drug formulation, manufacturing and other development;
•salaries and personnel-related costs, including benefits and any stock-based compensation, for personnel in research and development functions;
•fees paid to consultants and other third parties who support our product candidate development and intellectual property protection;
•medical affairs related expense and salary that is incurred to discover, develop, or improve potential product candidates;
•other costs in seeking regulatory approval of our products; and
Ibrexafungerp was the only key research and development project 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 ibrexafungerp, 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, information systems and marketing efforts.
Other Expense (Income)
All of our other income recognized in the three months ended March 31, 2023 and 2022, consists of amortization of debt issuance costs and discount, interest income, interest expense, other income, the warrant liabilities fair value adjustment, and the derivative liabilities fair value adjustment.
Income Tax Benefit
All of our income tax benefit recognized in the three months ended March 31, 2022 consists of an income tax benefit associated with the sale of our NOLs and research and development credits.
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Results of Operations for the Three Months Ended March 31, 2023 and 2022
The following table summarizes our results of operations for the three months ended March 31, 2023 and 2022, together with the changes in those items in dollars and percentage (dollars in thousands):
| | | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, | | |
| | 2023 | | | 2022 | | | Period-to-Period Change | | |
Revenue: | | | | | | | | | | | | | |
Product revenue, net | | $ | 1,130 | | | $ | 687 | | | $ | 443 | | | | 64.5 | | % |
Operating expenses: | | | | | | | | | | | | | |
Cost of product revenue | | | 137 | | | | 99 | | | | 38 | | | | 38.4 | | % |
Research and development | | | 6,835 | | | | 5,735 | | | | 1,100 | | | | 19.2 | | % |
Selling, general and administrative | | | 4,840 | | | | 14,591 | | | | (9,751 | ) | | | (66.8 | ) | % |
Total operating expenses | | | 11,812 | | | | 20,425 | | | | (8,613 | ) | | | (42.2 | ) | % |
Loss from operations | | | (10,682 | ) | | | (19,738 | ) | | | 9,056 | | | | (45.9 | ) | % |
Other expense (income): | | | | | | | | | | | | | |
Amortization of debt issuance costs and discount | | | 255 | | | | 390 | | | | (135 | ) | | | (34.6 | ) | % |
Interest income | | | (587 | ) | | | (13 | ) | | | (574 | ) | | | 4,415.4 | | % |
Interest expense | | | 1,447 | | | | 1,059 | | | | 388 | | | | 36.6 | | % |
Other income | | | — | | | | (13 | ) | | | 13 | | | | (100.0 | ) | % |
Warrant liabilities fair value adjustment | | | 21,673 | | | | (10,030 | ) | | | 31,703 | | | | (316.1 | ) | % |
Derivative liabilities fair value adjustment | | | 406 | | | | (980 | ) | | | 1,386 | | | | (141.4 | ) | % |
Total other expense (income) | | | 23,194 | | | | (9,587 | ) | | | 32,781 | | | | (341.9 | ) | % |
Loss before taxes | | | (33,876 | ) | | | (10,151 | ) | | | (23,725 | ) | | | 233.7 | | % |
Income tax benefit | | | — | | | | (4,700 | ) | | | 4,700 | | | | (100.0 | ) | % |
Net loss | | $ | (33,876 | ) | | $ | (5,451 | ) | | $ | (28,425 | ) | | | 521.5 | | % |
Revenue. Revenue in the three months ended March 31, 2023 and 2022 consists solely of product sales of BREXAFEMME.
Cost of Product Revenue. Cost of product revenue in the three months ended March 31, 2023 and 2022 consists primarily of distribution, freight, and royalty costs associated with BREXAFEMME.
Research and Development. For the three months ended March 31, 2023, research and development expenses increased to $6.8 million compared to $5.7 million for the three months ended March 31, 2022. The increase of $1.1 million, or 19%, for the three months ended March 31, 2023, was primarily driven by an increase of $0.6 million in clinical development expense and an increase of $0.6 million in medical affairs expense.
The $0.6 million increase in clinical development expense for the three months ended March 31, 2023, was primarily driven by an increase of $0.7 million associated with a Phase 1 study of oral ibrexafungerp that was substantially completed in the current period and is intended to support the potential NDA filing for the treatment of IC, an increase of $0.3 million in the FURI and CARES studies, and an increase of $0.2 million in expense associated with the VANQUISH study, offset in part by a $0.8 million decrease in expense associated with the CANDLE Phase 3 study which was substantially complete in the first quarter of 2022.
Selling, General & Administrative. For the three months ended March 31, 2023, selling, general and administrative expenses decreased to $4.8 million from $14.6 million for the three months ended March 31, 2022. The decrease of $9.8 million, or 67%, for the three months ended March 31, 2023, was primarily driven by a decrease of $7.3 million in commercial expense due to the costs incurred in the prior comparable period associated with the active promotion of BREXAFEMME which ceased in the fourth quarter of 2022, a decrease of $1.4 million in salary related expense primarily driven by the workforce reduction in the fourth quarter of 2022 concentrated in the commercial and medical affairs functions, a $0.5 million decrease associated with other medical affairs related expense, and a net decrease of $0.6 million in other selling, general, and administrative expenses.
Amortization of Debt Issuance Costs and Discount. For the three months ended March 31, 2023 and 2022, we recognized $0.3 million and $0.4 million in amortization of debt issuance costs and discount, respectively. The 2023 and 2022 debt issuance costs and discount for our March 2019 convertible notes primarily consisted of an allocated portion of advisory fees and other issuance costs and the initial fair value of the derivative liability. The 2023 and 2022 debt issuance costs and discount for our Loan Agreement comprised issuance and commitment costs, customary closing and final fees, and the fair value of the warrants issued in conjunction with the Loan Agreement.
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Interest Income. For the three months ended March 31, 2023 and 2022, we recognized $0.6 million and $13,000, respectively, in interest income; the increase was primarily due to the increase in the interest rate on our money market fund.
Interest Expense. For the three months ended March 31, 2023 and 2022, we recognized $1.4 million and $1.1 million, respectively, in interest expense primarily associated with the Loan Agreement.
Other Income. For the three months ended March 31, 2022, we recognized $13,000 in other income primarily associated with realized gains on foreign currency transactions.
Warrant Liabilities Fair Value Adjustment. For the three months ended March 31, 2023 and 2022, we recognized a loss of $21.7 million and a gain $10.0 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 periods, respectively.
Derivative Liabilities Fair Value Adjustment. For the three months ended March 31, 2023 and 2022, we recognized a loss of $0.4 million and a gain of $1.0 million, respectively, in the fair value adjustment related to the derivative liabilities primarily due to the increase and decrease in our stock price during the respective periods.
Income Tax Benefit. Income tax benefit in the three months ended March 31, 2022 consists of $4.7 million associated with the sale of a portion of our NOLs and research and development credits.
Liquidity and Capital Resources
Sources of Liquidity
Through March 31, 2023, we have primarily funded our operations from net proceeds from equity and debt issuances and through revenue from development services. As of March 31, 2023, we had cash and cash equivalents and short-term investments of $54.8 million, compared to cash and cash equivalents and short-term investments of $73.5 million as of December 31, 2022. The decrease in our cash and cash equivalents and short-term investments was primarily due to the continued development costs associated with ibrexafungerp and the payment of the deferred fees associated with Amplity. We have incurred annual net losses since our inception, and we incurred a net loss during the three months ended March 31, 2023. As of March 31, 2023, our accumulated deficit was $456.2 million.
If we do not successfully close the License Agreement with GSK, we will likely continue to incur losses for at least the foreseeable future. Consistent with our operating plan, we expect to incur significant research and development expenses and selling, general and administrative expenses; however, we expect our selling, general, and administrative expenses will decrease as we have ceased the active promotion of BREXAFEMME. As a result of our continued significant expenses, we may need additional capital to fund our operations, which we may obtain through one or more of equity offerings, debt financings, or other non-dilutive third-party funding, strategic alliances and licensing or collaboration arrangements. We may offer shares of our common stock pursuant to our shelf registrations, including the related at-the-market facility entered into on May 17, 2021 with Cantor and Ladenburg. Upon closing of our License Agreement with GSK that is expected in the second quarter of 2023, we will receive $90.0 million, of which approximately $37.1 million we must use to pay all amounts payable under the Loan Agreement with Hercules Capital and SVB.
Cash Flows
The following table sets forth the significant sources and uses of cash for the three months ended March 31, 2023 and 2022 (in thousands):
| | | | | | | | |
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Cash, cash equivalents, and restricted cash, January 1 | | $ | 46,032 | | | $ | 104,702 | |
Net cash used in operating activities | | | (18,923 | ) | | | (15,988 | ) |
Net cash used in investing activities | | | — | | | | (9 | ) |
Net cash provided by financing activities | | | 22 | | | | 6,723 | |
Net decrease in cash, cash equivalents, and restricted cash | | | (18,901 | ) | | | (9,274 | ) |
Cash, cash equivalents, and restricted cash, March 31 | | $ | 27,131 | | | $ | 95,428 | |
Operating Activities
The $2.9 million increase in net cash used in operating activities for the three months ended March 31, 2023, as compared to the three months ended March 31, 2022, was primarily due to the continued development costs associated with ibrexafungerp. In the prior comparable period, we received a cash receipt of $4.7 million the sale of our NOLs, that partially offset selling, general and administrative expenses to support the commercial launch of BREXAFEMME and the continued development costs associated with ibrexafungerp and ongoing operations. Consistent with our operating plan, we expect to
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incur significant research and development expenses; however, we expect our selling, general and administrative expenses to decrease as we have ceased actively promoting BREXAFEMME.
Net cash used in operating activities of $18.9 million for the three months ended March 31, 2023, primarily consisted of the $33.9 million net loss adjusted for non-cash charges that included the loss on change in fair value of the warrant liabilities of $21.7 million, the loss on change in fair value of the derivative liabilities of $0.4 million, stock-based compensation expense of $0.7 million, and amortization of debt issuance costs and discount of $0.3 million, partially offset by a net unfavorable change in operating assets and liabilities of $8.6 million. The net unfavorable change in operating assets and liabilities was due to a decrease in accounts payable, accrued expenses, other liabilities and other of $6.7 million and by an increase in prepaid expenses, accounts receivable, inventory, and other of $1.9 million. The $6.7 million decrease in accounts payable, accrued expenses, other liabilities, and other was primarily due to the decrease of $5.8 million in other liabilities associated with the deferred fees due to Amplity that were fully paid as of February 2023 and a $0.9 million decrease in accrued expenses primary due to the bonus and separation payments made during the current period for 2022. The increase in prepaid expenses, accounts receivable, inventory, and other of $1.9 million was primarily due to a $2.1 million increase in inventory for raw material purchased in the current period.
Net cash used in operating activities of $16.0 million for the three months ended March 31, 2022, primarily consisted of the $5.5 million net loss adjusted for non-cash charges that included the gain on change in fair value of the warrant liabilities of $10.0 million, the gain on change in fair value of the derivative liabilities of $1.0 million, stock-based compensation expense of $0.9 million, amortization of debt issuance costs and discount of $0.4 million, plus a net unfavorable change in operating assets and liabilities of $1.0 million. The net unfavorable change in operating assets and liabilities was due to an increase in accounts payable, accrued expenses, other liabilities and other of $0.4 million, offset by an increase in prepaid expenses, accounts receivable, inventory, and other of $1.4 million. The $0.4 million increase in accounts payable, accrued expenses, other liabilities, and other was primarily due to the increase in accounts payable of $0.7 million and an increase of $0.9 million in other liabilities associated with the deferred fees due to Amplity, offset in part by a decrease in accrued expenses of $1.2 million primarily due to the $1.5 million decrease in accrued bonus that was paid during the current quarter. The increase in prepaid expenses, accounts receivable, inventory, and other of $1.4 million was primarily due to the increase in accounts receivable of $0.8 million, a $0.5 million increase in prepaid research and development services, and an increase of $0.3 million in inventory.
Investing Activities
Net cash used in investing activities of $9,000 for the three months ended March 31, 2022, consisted solely of purchases of intangible assets.
Financing Activities
Net cash provided by financing activities of $22,000 for the three months ended March 31, 2023, consisted primarily of the proceeds for the repurchase of shares to satisfy tax withholdings and the proceeds from the employee stock purchase plan.
Net cash provided by financing activities of $6.7 million for the three months ended March 31, 2022, consisted primarily of the gross proceeds of $5.0 million received from the Loan Agreement and $2.2 million in gross proceeds from common stock issued under our at-the-market and common stock purchase agreements.
Future Funding Requirements
We have generated limited revenue from the product sales for BREXAFEMME and we expect our product sales to decrease as we have ceased actively promoting BREXAFEMME. 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 anticipate that we will need substantial additional funding in connection with our continuing future operations. As discussed in Note 1 to the unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, we have incurred significant losses and negative cash flows from operations and have limited capital resources to fund ongoing operations which raises substantial doubt about our ability to continue as a going concern.
We received $30.0 million in 2021 and received $5.0 million in 2022 under our Loan Agreement with Hercules and Silicon Valley Bank. In March 2023, in connection with the entering into of the License Agreement with GSK, we, Hercules and SVB entered into a First Amendment and Consent to Loan and Security Agreement pursuant to which the lenders under the Loan Agreement consented to us entering into the License Agreement and we agreed to pay to the lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement (approximately $35.4 million), (ii) the prepayment fee payable under Loan Agreement ($262,500), (iii) the final
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payment payable under Loan Agreement ($1,382,500), and (iv) all other sums, if any, that shall have become due and payable with respect to loan advances under the Loan Agreement. These payments by us will become due upon the earliest of (A) one business day following receipt by us of the $90 million upfront payment payable to us under the License Agreement, (B) June 1, 2023, or (C) the termination of the License Agreement.
Our future capital requirements will depend on many factors, including:
•our ability to close the transactions contemplated by the License Agreement with GSK;
•the progress, and costs, of the clinical development of ibrexafungerp;
•the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;
•the ability of product candidates to progress through clinical development successfully;
•our need to expand our research and development activities;
•the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities;
•our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;
•our need and ability to hire additional management and scientific and medical personnel;
•our need to implement additional, as well as to enhance existing, internal systems and infrastructure, including financial and reporting processes and systems and the associated compliance costs; and
•the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.
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, in particular the License Agreement with GSK. 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, similar to our Loan Agreement or the convertible senior notes we sold in March 2019 and April 2020, 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 Judgements
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 judgements are described within Item 7 to our Annual Report on Form 10-K for the year ended December 31, 2022.
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Item 3. Quantitative and Qualitative Disclosure about Market Risk.
This item is not applicable to smaller reporting companies.
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 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 March 31, 2023, 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 Securities Exchange Act of 1934). 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 March 31, 2023, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
During the quarter ended March 31, 2023, 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 Securities Exchange Act of 1934, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1A. Risk Factors.
Our operations and financial results are subject to various risks and uncertainties, including those described in Part I, Item 1A, "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022.
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Item 6. Exhibits.
| | |
Exhibit Number | | Description of Document |
| | |
3.1 | | Amended and Restated Certificate of Incorporation (Filed with the SEC as Exhibit 3.1 to our current report on Form 8-K, filed with the SEC on May 12, 2014, SEC File No. 001-36365, and incorporated by reference here). |
| | |
3.2 | | Certificate of Amendment of Amended and Restated Certificate of Incorporation of SCYNEXIS, Inc. (Filed with the SEC as Exhibit 3.2 to our Form 10-Q, filed with the SEC on August 7, 2019, SEC File No. 001-36365, and incorporated by reference here). |
| | |
3.3 | | Certificate of Amendment of Amended and Restated Certificate of Incorporation of SCYNEXIS, Inc. (Filed with the SEC as Exhibit 3.1 to our Form 8-K, filed with the SEC on July 16, 2020, SEC File No. 001-36365, and incorporated by reference here). |
| | |
3.4 | | Certificate of Amendment of Amended and Restated Certificate of Incorporation of SCYNEXIS, Inc. (Filed with the SEC as Exhibit 3.4 to our Form 10-Q, filed with SEC on November 9, 2022, SEC File No. 001-36365, and incorporated by reference here). |
| | |
3.5 | | Amended and Restated By-Laws (Filed with the SEC as Exhibit 3.4 to our Registration Statement on Form S-1, filed with the SEC on February 27, 2014, SEC File No. 333-194192, and incorporated by reference here). |
| | |
4.1 | | Reference is made to Exhibits 3.1 through 3.5. |
| | |
10.1 | | Exclusive License Agreement, dated as of March 30, 2023, by and between GlaxoSmithKline Intellectual Property (No.3) Limited, and the Company. |
| | |
10.2 | | First Amendment and Consent to Loan and Security Agreement, dated March 30, 2023, among the Company, Hercules Capital, Inc., and Silicon Valley Bank. |
| | |
10.3 | | Separation Agreement, dated October 20, 2022, between SCYNEXIS, Inc. and Christine Coyne. |
| | |
10.4 | | Employment Agreement, dated January 1, 2023, between SCYNEXIS, Inc. and David Angulo (Filed with the SEC as Exhibit 10.39 to our Form 10-K, filed with the SEC on March 31, 2023, SEC File No. 001-36365, and incorporated by reference here). |
| | |
31.1 | | Certification of Chief Executive Officer pursuant to Rule 13-a-14(a) or Rule 15(d)-14(a) of the Exchange Act. |
| | |
31.2 | | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act. |
| | |
32.1 | | Certification of Chief Executive Officer and Chief Financial Officer pursuant to 13a-14(b) or 15d-14(b) of the Exchange Act. |
| | |
101.INS | | Inline XBRL Instance Document |
| | |
101.SCH | | Inline XBRL Taxonomy Schema Linkbase Document |
| | |
101.CAL | | Inline XBRL Taxonomy Calculation Linkbase Document |
| | |
101.DEF | | Inline XBRL Taxonomy Definition Linkbase Document |
| | |
101.LAB | | Inline XBRL Taxonomy Labels Linkbase Document |
| | |
101.PRE | | Inline XBRL Taxonomy Presentation Linkbase Document |
| | |
104 | | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
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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. |
| | |
By: | | /s/ David Angulo, M.D. |
| | David Angulo, M.D. |
| | Chief Executive Officer (Principal Executive Officer) |
| | |
Date: | | May 9, 2023 |
| | |
By: | | /s/ Ivor Macleod |
| | Ivor Macleod |
| | Chief Financial Officer (Principal Financial and Accounting Officer) |
| | |
Date: | | May 9, 2023 |
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