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Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024

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. ☐

 


Table of Contents

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As of November 1, 2024, there were 37,948,991 shares of the registrant’s Common Stock outstanding.

 

 


Table of Contents

 

SCYNEXIS, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2024

TABLE OF CONTENTS

 

 

 

 

 

Page

 

 

 

PART I FINANCIAL INFORMATION

 

1

 

 

 

 

 

Item 1.

 

Financial Statements

 

1

 

 

Unaudited Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023

 

1

 

 

Unaudited Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024 and 2023

 

2

 

 

Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023

 

3

 

 

Notes to the Condensed Consolidated Financial Statements (unaudited)

 

4

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

18

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

26

Item 4.

 

Controls and Procedures

 

26

 

 

 

PART II OTHER INFORMATION

 

27

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

27

Item 1A.

 

Risk Factors

 

27

Item 6.

 

Exhibits

 

28

 

 

 

Signatures

 

29

 

 


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)

 

 

September 30, 2024

 

 

December 31, 2023

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

28,730

 

 

$

34,050

 

Short-term investments

 

 

40,098

 

 

 

40,312

 

Prepaid expenses and other current assets

 

 

1,538

 

 

 

5,548

 

License agreement receivable

 

 

153

 

 

 

2,463

 

License agreement contract asset

 

 

9,509

 

 

 

19,363

 

Restricted cash

 

 

435

 

 

 

380

 

Total current assets

 

 

80,463

 

 

 

102,116

 

Investments

 

 

16,116

 

 

 

23,594

 

Deferred offering costs

 

 

187

 

 

 

175

 

Restricted cash

 

 

109

 

 

 

163

 

Operating lease right-of-use asset (See Note 7)

 

 

2,163

 

 

 

2,364

 

Total assets

 

$

99,038

 

 

$

128,412

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,955

 

 

$

7,149

 

Accrued expenses

 

 

5,508

 

 

 

7,495

 

Deferred revenue, current portion

 

 

1,642

 

 

 

1,189

 

Operating lease liability, current portion (See Note 7)

 

 

389

 

 

 

340

 

Warrant liabilities

 

 

 

 

 

130

 

Convertible debt and derivative liability (See Note 6)

 

 

13,225

 

 

 

 

Total current liabilities

 

 

25,719

 

 

 

16,303

 

Deferred revenue

 

 

1,294

 

 

 

2,727

 

Warrant liabilities

 

 

11,212

 

 

 

21,680

 

Convertible debt and derivative liability (See Note 6)

 

 

 

 

 

12,159

 

Operating lease liability (See Note 7)

 

 

2,284

 

 

 

2,581

 

Total liabilities

 

 

40,509

 

 

 

55,450

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.001 par value, authorized 5,000,000 shares as of September 30, 2024 and December 31, 2023; 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023

 

 

 

 

 

 

Common stock, $0.001 par value, 150,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 37,943,241 and 37,207,799 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

 

 

41

 

 

 

40

 

Additional paid-in capital

 

 

430,590

 

 

 

428,169

 

Accumulated deficit

 

 

(372,102

)

 

 

(355,247

)

Total stockholders’ equity

 

 

58,529

 

 

 

72,962

 

Total liabilities and stockholders’ equity

 

$

99,038

 

 

$

128,412

 

The accompanying notes are an integral part of the financial statements.

1


Table of Contents

 

SCYNEXIS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Product (loss) revenue, net

 

$

 

 

$

(614

)

 

$

 

 

$

984

 

License agreement revenue

 

 

660

 

 

 

2,375

 

 

 

2,769

 

 

 

133,360

 

Total revenue

 

 

660

 

 

 

1,761

 

 

 

2,769

 

 

 

134,344

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenue

 

 

 

 

 

379

 

 

 

 

 

 

940

 

Research and development

 

 

8,073

 

 

 

6,466

 

 

 

22,091

 

 

 

20,342

 

Selling, general and administrative

 

 

2,907

 

 

 

5,014

 

 

 

9,742

 

 

 

17,328

 

Total operating expenses

 

 

10,980

 

 

 

11,859

 

 

 

31,833

 

 

 

38,610

 

(Loss) income from operations

 

 

(10,320

)

 

 

(10,098

)

 

 

(29,064

)

 

 

95,734

 

Other (income) expense:

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of debt issuance costs and discount

 

 

441

 

 

 

360

 

 

 

1,262

 

 

 

2,616

 

Interest income

 

 

(1,020

)

 

 

(1,263

)

 

 

(3,422

)

 

 

(2,590

)

Interest expense

 

 

213

 

 

 

212

 

 

 

617

 

 

 

2,908

 

Warrant liabilities fair value adjustment

 

 

(6,751

)

 

 

(7,468

)

 

 

(10,598

)

 

 

5,991

 

Derivative liabilities fair value adjustment

 

 

 

 

 

(182

)

 

 

(196

)

 

 

182

 

Total other (income) expense

 

 

(7,117

)

 

 

(8,341

)

 

 

(12,337

)

 

 

9,107

 

(Loss) income before taxes

 

 

(3,203

)

 

 

(1,757

)

 

 

(16,727

)

 

 

86,627

 

Income tax (benefit) expense

 

 

(395

)

 

 

 

 

 

128

 

 

 

 

Net (loss) income

 

$

(2,808

)

 

$

(1,757

)

 

$

(16,855

)

 

$

86,627

 

Net (loss) income per share attributable to common stockholders – basic

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share – basic

 

$

(0.06

)

 

$

(0.04

)

 

$

(0.35

)

 

$

1.81

 

Net (loss) income per share attributable to common stockholders – diluted

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share – diluted

 

$

(0.06

)

 

$

(0.04

)

 

$

(0.35

)

 

$

1.78

 

Weighted average common shares outstanding – basic and diluted

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

48,618,693

 

 

 

47,891,996

 

 

 

48,459,777

 

 

 

47,829,614

 

Diluted

 

 

48,618,693

 

 

 

47,891,996

 

 

 

48,459,777

 

 

 

49,397,273

 

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)

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Cash flows from operating activities:

 

 

 

 

 

 

Net (loss) income

 

$

(16,855

)

 

$

86,627

 

Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

 

 

 

451

 

Stock-based compensation expense

 

 

2,365

 

 

 

2,067

 

Accretion of investments discount

 

 

(1,097

)

 

 

(702

)

Amortization of debt issuance costs and discount

 

 

1,262

 

 

 

2,616

 

Change in fair value of warrant liabilities

 

 

(10,598

)

 

 

5,991

 

Change in fair value of derivative liabilities

 

 

(196

)

 

 

182

 

Noncash operating lease expense for right-of-use asset

 

 

201

 

 

 

169

 

Write off of deferred asset for commitment fees

 

 

 

 

 

514

 

Prepayment fee for loan payable payment

 

 

 

 

 

263

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses, other assets, deferred costs, and other

 

 

4,032

 

 

 

(668

)

License agreement receivable

 

 

2,310

 

 

 

(2,349

)

License agreement contract asset

 

 

9,854

 

 

 

(19,309

)

Accounts receivable

 

 

 

 

 

(144

)

Inventory

 

 

 

 

 

(7,387

)

Accounts payable

 

 

(2,166

)

 

 

(2,447

)

Accrued expenses

 

 

(1,987

)

 

 

3,915

 

Deferred revenue

 

 

(979

)

 

 

4,081

 

Other liabilities and other

 

 

(248

)

 

 

(5,976

)

Net cash (used in) provided by operating activities

 

 

(14,102

)

 

 

67,894

 

Cash flows from investing activities:

 

 

 

 

 

 

Purchase of investments

 

 

(27,985

)

 

 

(73,275

)

Maturity of investments

 

 

36,752

 

 

 

40,550

 

Net cash provided by (used in) investing activities

 

 

8,767

 

 

 

(32,725

)

Cash flows from financing activities:

 

 

 

 

 

 

Payments of deferred offering costs

 

 

(40

)

 

 

 

Payments of loan payable

 

 

 

 

 

(36,383

)

Payment of loan payable prepayment fee

 

 

 

 

 

(263

)

Proceeds from employee stock purchase plan issuances

 

 

56

 

 

 

42

 

Repurchase of shares to satisfy tax withholdings

 

 

 

 

 

18

 

Net cash provided by (used in) financing activities

 

 

16

 

 

 

(36,586

)

Net decrease in cash, cash equivalents, and restricted cash

 

 

(5,319

)

 

 

(1,417

)

Cash, cash equivalents, and restricted cash at beginning of period

 

 

34,593

 

 

 

46,032

 

Cash, cash equivalents, and restricted cash at end of period

 

$

29,274

 

 

$

44,615

 

Supplemental cash flow information:

 

 

 

 

 

 

Cash paid for interest

 

$

840

 

 

$

3,248

 

Cash received for interest

 

$

2,623

 

 

$

2,644

 

Noncash financing and investing activities:

 

 

 

 

 

 

Deferred offering costs included in accounts payable

 

$

12

 

 

$

 

 

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 proprietary class of enfumafungin-derived antifungal compounds (“fungerps") as broad-spectrum, systemic antifungal agents for multiple fungal indications. Ibrexafungerp is the first representative of this novel class of antifungals with additional assets from the “fungerp” family, including SCY-247, in preclinical stages of development. 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, and 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 "GSK License Agreement") with GlaxoSmithKline Intellectual Property (No. 3) Limited ("GSK") 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.

Following a review by GSK of the manufacturing process and equipment at the vendor that manufactures the ibrexafungerp drug substance, the Company became aware that a non-antibacterial beta-lactam drug substance was manufactured using equipment common to the manufacturing process for ibrexafungerp. Current FDA draft guidance recommends segregating the manufacture of non-antibacterial beta-lactam compounds from other compounds since beta-lactam compounds have the potential to act as sensitizing agents that may trigger hypersensitivity or an allergic reaction in some people. In the absence of the recommended segregation, there is a risk of cross contamination. It is not known whether any ibrexafungerp has been contaminated with a beta-lactam compound and the Company has not received reports of any adverse events due to the possible beta-lactam cross contamination. Nonetheless, out of an abundance of caution and in line with GSK’s recommendation, the Company has recalled BREXAFEMME® (ibrexafungerp tablets) from the market and placed a temporary hold on clinical studies of ibrexafungerp, including the Phase 3 MARIO study.

The clinical hold and recall affect the Company's two ongoing clinical studies: the Phase 3 MARIO study and a Phase 1 lactation study. The hold does not impact the completed FURI, CARES, VANQUISH and SCYNERGIA clinical studies. The FDA determined that the compassionate use program for ibrexafungerp, which provides ibrexafungerp to patients with limited or no other treatment options, can continue provided the patient’s treating physician concludes a favorable benefit-risk assessment and the patient is made aware of and consents to the risk. This applies to patients currently in the program, as well as for new patients, pending confirmation of available supply. The Company's preclinical stage compound, SCY-247, is not affected by these developments.

The patient-level and clinical product recall is ongoing and the Company is working with an experienced vendor to manage the process. In September 2023, after the Company announced its voluntary clinical hold, the FDA concurred with the Company's voluntary hold and placed a clinical hold. The Company is working on the resolution of this issue and anticipates the restart of the MARIO study, after FDA's lifting of the clinical hold, in the first quarter of 2025.

The Company had an accumulated deficit of $372.1 million at September 30, 2024. The Company's capital resources primarily comprised cash and cash equivalents and investments of $84.9 million at September 30, 2024. While the Company believes its capital resources are sufficient to fund the Company’s on-going operations for a period of at least 12 months subsequent to the issuance of the accompanying unaudited condensed consolidated financial statements, the Company's liquidity could be materially affected over this period by: (1) its ability to raise additional capital through equity offerings, debt financings, or other non-dilutive third-party funding; (2) costs associated with new or existing strategic alliances, or licensing and collaboration arrangements; (3) negative regulatory events or unanticipated costs related to its development of SCY-247 and ibrexafungerp; (4) its ability to successfully achieve the development, regulatory, and commercial milestones under its GSK License Agreement; and (5) any other unanticipated material negative events or costs. One or more of these events or costs could materially affect the Company’s liquidity. If the Company is unable to meet its obligations when they become due, the Company may have to delay expenditures, reduce the scope of its research and development programs, or make significant

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changes to its operating plan. The accompanying unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

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.

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; estimates for the relative standalone selling price and measure of progress under the input method for the GSK License Agreement; estimates for product recall reserves; 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 and nine months ended September 30, 2024, 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 28, 2024.

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, 2023, except as described below.

Basic and Diluted Net (Loss) Income per Share of Common Stock

The Company calculates net (loss) income per common share in accordance with ASC 260, Earnings Per Share. Basic net (loss) income per common share for the three and nine months ended September 30, 2024 and 2023 was determined by dividing net (loss) income 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) income per common share for the three and nine months ended September 30, 2024 and 2023 includes the outstanding prefunded warrants to purchase 7,516,267 and 3,200,000 shares of common stock issued in the April 2022 public offering and December 2020 public offering, respectively. Diluted net (loss) income per common share for the three and nine months ended September 30, 2024 and 2023 was determined as follows (in thousands, except share and per share amounts):

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net (loss) income allocated to common shares

$

(2,808

)

 

$

(1,757

)

 

$

(16,855

)

 

$

86,627

 

Dilutive effect of convertible debt

 

 

 

 

 

 

 

 

 

 

1,437

 

Net (loss) income allocated to common shares

$

(2,808

)

 

$

(1,757

)

 

$

(16,855

)

 

$

88,064

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding – basic

 

48,618,693

 

 

 

47,891,996

 

 

 

48,459,777

 

 

 

47,829,614

 

Dilutive effect of convertible debt

 

 

 

 

 

 

 

 

 

 

1,138,200

 

Dilutive effect of restricted stock units

 

 

 

 

 

 

 

 

 

 

429,459

 

Weighted average common shares outstanding – diluted

 

48,618,693

 

 

 

47,891,996

 

 

 

48,459,777

 

 

 

49,397,273

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share – diluted

$

(0.06

)

 

$

(0.04

)

 

$

(0.35

)

 

$

1.78

 

 

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The following potentially dilutive shares of common stock and outstanding restricted stock units that contain certain performance contingencies have not been included in the computation of diluted net (loss) income per share for the three and nine months ended September 30, 2024 and 2023, as the result would be anti-dilutive or the performance contingencies have not been met:

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Outstanding stock options

 

2,912,307

 

 

 

1,960,411

 

 

 

2,912,307

 

 

 

1,960,411

 

Outstanding restricted stock units

 

3,151,124

 

 

 

2,054,970

 

 

 

3,151,124

 

 

 

400,000

 

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

 

 

 

15,000,000

 

 

 

15,000,000

 

 

 

15,000,000

 

Warrants to purchase common stock associated with Loan Agreement

 

198,811

 

 

 

198,811

 

 

 

198,811

 

 

 

198,811

 

Common stock associated with March 2019 Notes

 

1,138,200

 

 

 

1,138,200

 

 

 

1,138,200

 

 

 

 

Warrants to purchase common stock associated with Danforth

 

50,000

 

 

 

50,000

 

 

 

50,000

 

 

 

50,000

 

Total

 

22,450,442

 

 

 

27,202,392

 

 

 

22,450,442

 

 

 

24,409,222

 

Reclassification of Prior Year Amounts

Certain prior year amounts within the changes in operating assets and liabilities on the unaudited condensed consolidated statement of cash flows and certain prior year accrued expenses have been reclassified for consistency with the current year presentation.

Recently Adopted 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. The Company adopted ASU 2020-06 on January 1, 2024 and the adoption did not materially impact the unaudited condensed consolidated financial statements.

Recently Issued Accounting Pronouncements

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures, which introduced new guidance on disclosures for reportable segments and significant segment expenses, including for entities with a single reportable segment. This guidance is effective for the Company for annual reporting periods beginning January 1, 2024 and interim periods beginning January 1, 2025. As a smaller reporting company, the Company is currently evaluating the impact ASU 2023-07 will have on its consolidated financial statements.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures, which introduced new guidance on disclosures for income taxes, including enhancements to the rate reconciliation and income taxes paid disclosures. This guidance is effective for the Company for annual reporting periods beginning January 1, 2025. As a smaller reporting company, the Company is currently evaluating the impact ASU 2023-09 will have on its consolidated financial statements.
 

3. Investments

The following table summarizes the investments at September 30, 2024 (in thousands):

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Table of Contents

 

 

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair Value

 

As of September 30, 2024

 

 

 

 

 

 

 

 

 

 

 

 

Maturities < 1 Year

 

 

 

 

 

 

 

 

 

 

 

 

Corporate bonds

 

$

37,138

 

 

$

126

 

 

$

(2

)

 

$

37,262

 

Agency bonds

 

 

2,960

 

 

 

9

 

 

 

 

 

 

2,969

 

Total short-term investments

 

$

40,098

 

 

$

135

 

 

$

(2

)

 

$

40,231

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Maturities > 1 Year

 

 

 

 

 

 

 

 

 

 

 

 

Corporate bonds

 

$

16,116

 

 

$

81

 

 

$

(4

)

 

$

16,193

 

Total investments

 

$

16,116

 

 

$

81

 

 

$

(4

)

 

$

16,193

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2023

 

 

 

 

 

 

 

 

 

 

 

 

Maturities < 1 Year

 

 

 

 

 

 

 

 

 

 

 

 

Corporate bonds

 

$

35,286

 

 

$

25

 

 

$

(13

)

 

$

35,298

 

Agency bonds

 

 

5,026

 

 

 

6

 

 

 

 

 

 

5,032

 

Total short-term investments

 

$

40,312

 

 

$

31

 

 

$

(13

)

 

$

40,330

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Maturities > 1 Year

 

 

 

 

 

 

 

 

 

 

 

 

Corporate bonds

 

$

23,594

 

 

$

143

 

 

$

(9

)

 

$

23,728

 

Total investments

 

$

23,594

 

 

$

143

 

 

$

(9

)

 

$

23,728

 

The Company carries investments at amortized cost. As of September 30, 2024 and December 31, 2023, the fair value of the corporate and agency bonds totals $56.4 million and $64.1 million, respectively, which is determined based on “Level 2” inputs, which consist of quoted prices for similar assets in active markets. The Company has evaluated the unrealized loss position in the corporate and agency bonds as of the balance sheet dates 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.

4. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):

 

 

September 30, 2024

 

 

December 31, 2023

 

Prepaid research and development services

 

$

 

 

$

196

 

Prepaid insurance

 

 

427

 

 

 

264

 

Other prepaid expenses

 

 

158

 

 

 

182

 

Other current assets

 

 

953

 

 

 

4,906

 

Total prepaid expenses and other current assets

 

$

1,538

 

 

$

5,548

 

 

5. Accrued Expenses

Accrued expenses consisted of the following (in thousands):

 

 

 

September 30, 2024

 

 

December 31, 2023

 

Accrued research and development expenses

 

$

1,866

 

 

$

2,830

 

Accrued employee bonus compensation

 

 

1,337

 

 

 

1,692

 

Other accrued expenses

 

 

969

 

 

 

1,040

 

Accrued product recall

 

 

1,336

 

 

 

1,933

 

Total accrued expenses

 

$

5,508

 

 

$

7,495

 

 

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6. Borrowings

Loan Agreement

On May 13, 2021 (the “Closing Date”), the Company entered into the Loan and Security Agreement (the "Loan Agreement") with Hercules Capital, Inc. and Silicon Valley Bridge Bank, N.A. (as successor to Silicon Valley Bank) (the "Lenders") for an aggregate principal amount of $60.0 million (the “Term Loan”). Pursuant to the Loan Agreement, the Term Loan was available to the Company in four tranches, subject to certain terms and conditions.

In connection with the entering into of the GSK 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 GSK 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. Upon receipt by the Company of the $90.0 million upfront payment from GSK in May 2023, all amounts payable under the Loan Agreement were fully paid. In connection with the repayment of those amounts due, in May 2023, the Company and the Lenders executed a payoff letter confirming the amounts due under the Loan Agreement, and the Company’s confirmation that the Loan Agreement was terminated. For the nine months ended September 30, 2023, the Company recognized $2.0 million in amortization for the remaining debt issuance costs and discount associated with the Loan Agreement which was fully paid in May 2023.

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 September 30, 2024 and December 31, 2023, the Company’s March 2019 Notes consist of the convertible debt balance of $13.2 million and $12.0 million and the bifurcated embedded conversion option derivative liability of zero and $0.2 million, 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 and Level 3 inputs with changes in fair value recorded in the statements of operations in other (income) expense. For the three months ended September 30, 2024 and 2023, the Company recognized gains of zero and $0.2 million, respectively, on the fair value adjustment for the derivative liability. For the nine months ended September 30, 2024 and 2023, the Company recognized a gain of $0.2 million and a loss of $0.2 million, respectively, on the fair value adjustment for the derivative liability. For both the three months ended September 30, 2024 and 2023, the Company recognized $0.4 million in amortization of debt issuance costs and discount related to the March 2019 Notes. For the nine months ended September 30, 2024 and 2023, the Company recognized $1.3 million and $0.6 million, respectively, in amortization of debt issuance costs and discount related to the March 2019 Notes.

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.

 

7. Commitments and Contingencies

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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 September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Operating lease cost

 

$

166

 

 

$

166

 

 

$

498

 

 

$

498

 

Variable lease cost

 

 

28

 

 

 

44

 

 

 

32

 

 

 

148

 

Total operating lease expense

 

$

194

 

 

$

210

 

 

$

530

 

 

$

646

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash paid for amounts included in the measurement of operating lease liability

 

$

183

 

 

$

180

 

 

$

545

 

 

$

534

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30, 2024

 

 

December 31, 2023

 

Remaining Lease term (years)

 

 

 

 

 

 

 

 

4.84

 

 

 

5.59

 

Discount rate

 

 

 

 

 

 

 

 

15

%

 

 

15

%

 

Future minimum lease payments for the Lease as of September 30, 2024 are as follows (in thousands):

 

 

September 30, 2024

 

2024

 

$

185

 

2025

 

 

744

 

2026

 

 

759

 

2027

 

 

774

 

2028

 

 

790

 

Thereafter

 

 

466

 

Total

 

$

3,718

 

 

The presentations of the operating lease liability as of September 30, 2024 are as follows (in thousands):

 

 

 

September 30, 2024

 

Present value of future minimum lease payments

 

$

2,673

 

 

 

 

Operating lease liability, current portion

 

$

389

 

Operating lease liability, long-term portion

 

 

2,284

 

Total operating lease liability

 

$

2,673

 

 

 

 

Difference between future minimum lease payments and discounted cash flows

 

$

1,045

 

License Arrangement with Potential Future Expenditures

As of September 30, 2024, 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

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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.

Legal Proceedings

On November 7, 2023, a securities class action was filed by Brian Feldman against the Company and certain of the Company's executives in the United States District Court, District of New Jersey, alleging that, during the period from March 31, 2023 to September 22, 2023, the Company made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects, alleging specifically that the Company failed to disclose to investors: (1) that the equipment used to manufacture ibrexafungerp was also used to manufacture a non-antibacterial beta-lactam drug substance, presenting a risk of cross-contamination; (2) that the Company did not have effective internal controls and procedures, as well as adequate internal oversight policies to ensure that its vendor complied with current Good Manufacturing Practices (cGMP); (3) that, due to the substantial risk of cross-contamination, the Company were reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies; and (4) as a result of the foregoing, the Company's statements about its business, operations, and prospects were materially misleading and/or lacked a reasonable basis. The complaint seeks unspecified damages, interest, fees and costs on behalf of all persons and entities who purchased and/or acquired shares of the Company's common stock between March 31, 2023 to September 22, 2023. On May 1, 2024, and again on June 4, 2024, purported shareholder derivative complaints were filed in the United States District Court, District of New Jersey. The complaints name the Company’s directors and certain of its officers and assert state and federal claims based on the same alleged misstatements as the securities class action complaint. The Company disagrees with the allegations and intends to defend these litigations vigorously and the Company has not recognized any expense for these contingencies.

8. 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 September 30, 2024, and December 31, 2023; 37,943,241 and 37,207,799 shares were issued and outstanding at September 30, 2024 and December 31, 2023, respectively. For the nine months ended September 30, 2023, 4,150,400 of the prefunded warrants from the April 2022 public offering were exercised for total proceeds of $4,150.

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The following table summarizes common stock share activity for the three and nine months ended September 30, 2024 and 2023 (dollars in thousands):

 

 

Three Months Ended September 30, 2024

 

 

 

Shares of
Common Stock

 

 

Common
Stock

 

 

Additional
Paid-in
Capital

 

 

Accumulated
Deficit

 

 

Total
Stockholders’ Equity

 

Balance, June 30, 2024

 

 

37,856,463

 

 

$

41

 

 

$

429,659

 

 

$

(369,294

)

 

$

60,406

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(2,808

)

 

 

(2,808

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

900

 

 

 

 

 

 

900

 

Common stock issued through employee stock purchase plan

 

 

26,778

 

 

 

 

 

 

31

 

 

 

 

 

 

31

 

Common stock issued for vested restricted stock units

 

 

60,000

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, September 30, 2024

 

 

37,943,241

 

 

$

41

 

 

$

430,590

 

 

$

(372,102

)

 

$

58,529

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 2023

 

 

 

Shares of
Common Stock

 

 

Common
Stock

 

 

Additional
Paid-in
Capital

 

 

Accumulated
Deficit

 

 

Total
Stockholders’ Equity

 

Balance, June 30, 2023

 

 

37,175,665

 

 

$

40

 

 

$

426,942

 

 

$

(333,904

)

 

$

93,078

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(1,757

)

 

 

(1,757

)

Stock-based compensation expense