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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, 2022

OR

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

For the transition period to

Commission File Number 001-36365

 

SCYNEXIS, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

56-2181648

(State or other jurisdiction of

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 November 1, 2022, there were 32,656,992 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, 2022

TABLE OF CONTENTS

 

 

 

 

 

Page

 

 

 

PART I FINANCIAL INFORMATION

 

1

 

 

 

 

 

Item 1.

 

Financial Statements

 

1

 

 

Unaudited Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021

 

1

 

 

Unaudited Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2022 and 2021

 

2

 

 

Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2022 and 2021

 

3

 

 

Notes to the Condensed Consolidated Financial Statements (unaudited)

 

4

Item 2.

 

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

 

19

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

28

Item 4.

 

Controls and Procedures

 

28

 

 

 

PART II OTHER INFORMATION

 

28

 

 

 

 

 

Item 1A.

 

Risk Factors

 

28

Item 6.

 

Exhibits

 

29

 

 

 

Signatures

 

30

 

 


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, 2022

 

 

December 31, 2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

68,620

 

 

$

104,484

 

Short-term investments

 

 

27,470

 

 

 

 

Prepaid expenses and other current assets

 

 

4,141

 

 

 

3,569

 

Accounts receivable, net

 

 

2,493

 

 

 

861

 

Inventory, net

 

 

786

 

 

 

463

 

Restricted cash

 

 

55

 

 

 

 

Total current assets

 

 

103,565

 

 

 

109,377

 

Other assets

 

 

5,076

 

 

 

6,235

 

Deferred offering costs

 

 

73

 

 

 

150

 

Restricted cash

 

 

163

 

 

 

218

 

Intangible assets, net

 

 

770

 

 

 

1,056

 

Operating lease right-of-use asset (See Note 8)

 

 

2,646

 

 

 

2,801

 

Total assets

 

$

112,293

 

 

$

119,837

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

7,419

 

 

$

7,848

 

Accrued expenses

 

 

5,856

 

 

 

5,698

 

Other liabilities, current portion (See Note 7)

 

 

720

 

 

 

 

Operating lease liability, current portion (See Note 8)

 

 

269

 

 

 

70

 

Total current liabilities

 

 

14,264

 

 

 

13,616

 

Other liabilities (See Note 7)

 

 

4,898

 

 

 

3,345

 

Warrant liabilities

 

 

27,730

 

 

 

18,062

 

Convertible debt and derivative liability (See Note 7)

 

 

11,032

 

 

 

11,607

 

Loan payable

 

 

34,162

 

 

 

28,745

 

Operating lease liability (See Note 8)

 

 

2,998

 

 

 

3,204

 

Total liabilities

 

 

95,084

 

 

 

78,579

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.001 par value, authorized 5,000,000 shares as of September 30, 2022 and December 31, 2021; 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021

 

 

 

 

 

 

Common stock, $0.001 par value, 150,000,000 shares authorized as of September 30, 2022 and 100,000,000 shares as of December 31, 2021; 32,656,242 and 28,705,334 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively

 

 

36

 

 

 

32

 

Additional paid-in capital

 

 

425,032

 

 

 

400,705

 

Accumulated deficit

 

 

(407,859

)

 

 

(359,479

)

Total stockholders’ equity

 

 

17,209

 

 

 

41,258

 

Total liabilities and stockholders’ equity

 

$

112,293

 

 

$

119,837

 

 

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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

1,557

 

 

$

516

 

 

$

3,567

 

 

$

516

 

License agreement revenue

 

 

 

 

 

 

 

 

 

 

 

12,050

 

Total revenue

 

 

1,557

 

 

 

516

 

 

 

3,567

 

 

 

12,566

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenue

 

 

189

 

 

 

145

 

 

 

432

 

 

 

145

 

Research and development

 

 

6,430

 

 

 

4,401

 

 

 

19,410

 

 

 

16,083

 

Selling, general and administrative

 

 

16,739

 

 

 

15,411

 

 

 

47,001

 

 

 

34,879

 

Total operating expenses

 

 

23,358

 

 

 

19,957

 

 

 

66,843

 

 

 

51,107

 

Loss from operations

 

 

(21,801

)

 

 

(19,441

)

 

 

(63,276

)

 

 

(38,541

)

Other expense (income):

 

 

 

 

 

 

 

 

 

 

 

 

Loss on extinguishment of debt

 

 

 

 

 

 

 

 

 

 

 

2,725

 

Amortization of debt issuance costs and discount

 

 

396

 

 

 

413

 

 

 

1,194

 

 

 

937

 

Interest income

 

 

(531

)

 

 

(8

)

 

 

(724

)

 

 

(20

)

Interest expense

 

 

1,379

 

 

 

1,019

 

 

 

3,669

 

 

 

1,678

 

Warrant liabilities fair value adjustment

 

 

6,497

 

 

 

(18,810

)

 

 

(13,215

)

 

 

(35,378

)

Derivative liabilities fair value adjustment

 

 

42

 

 

 

(1,400

)

 

 

(1,120

)

 

 

(1,772

)

Total other expense (income)

 

 

7,783

 

 

 

(18,786

)

 

 

(10,196

)

 

 

(31,830

)

Loss before taxes

 

 

(29,584

)

 

 

(655

)

 

 

(53,080

)

 

 

(6,711

)

Income tax benefit

 

 

 

 

 

(50

)

 

 

(4,700

)

 

 

(3,088

)

Net loss

 

$

(29,584

)

 

$

(605

)

 

$

(48,380

)

 

$

(3,623

)

Net loss per share attributable to common stockholders – basic

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share – basic

 

$

(0.62

)

 

$

(0.02

)

 

$

(1.18

)

 

$

(0.14

)

Net loss per share attributable to common stockholders – diluted

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share – diluted

 

$

(0.62

)

 

$

(0.06

)

 

$

(1.18

)

 

$

(0.73

)

Weighted average common shares outstanding – basic and diluted

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

47,503,821

 

 

 

26,616,628

 

 

 

40,965,908

 

 

 

26,147,658

 

Diluted

 

 

47,503,821

 

 

 

27,754,828

 

 

 

40,965,908

 

 

 

26,326,006

 

 

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

2


Table of Contents

 

SCYNEXIS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

 

 

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(48,380

)

 

$

(3,623

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

451

 

 

 

133

 

Stock-based compensation expense

 

 

3,232

 

 

 

1,528

 

Accretion of short-term investment discount

 

 

(90

)

 

 

 

Amortization of debt issuance costs and discount

 

 

1,194

 

 

 

937

 

Change in fair value of warrant liabilities

 

 

(13,215

)

 

 

(35,378

)

Change in fair value of derivative liabilities

 

 

(1,120

)

 

 

(1,772

)

Noncash operating lease expense for right-of-use asset

 

 

155

 

 

 

149

 

Loss on extinguishment of debt

 

 

 

 

 

2,725

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses, accounts receivable, inventory, and other

 

 

(1,729

)

 

 

1,271

 

Accounts payable, accrued expenses, other liabilities, and other

 

 

2,425

 

 

 

4,990

 

Net cash used in operating activities

 

 

(57,077

)

 

 

(29,040

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchase of intangible assets

 

 

(9

)

 

 

(589

)

Purchase of short-term investments

 

 

(27,380

)

 

 

 

Net cash used in investing activities

 

 

(27,389

)

 

 

(589

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from common stock issued

 

 

47,248

 

 

 

8,027

 

Payments of offering costs and underwriting discounts and commissions

 

 

(3,638

)

 

 

(151

)

Proceeds from loan payable

 

 

5,000

 

 

 

30,000

 

Payments of loan payable issuance costs

 

 

(26

)

 

 

(1,253

)

Proceeds from employee stock purchase plan issuances

 

 

18

 

 

 

22

 

Repurchase of shares to satisfy tax withholdings

 

 

 

 

 

(3

)

Net cash provided by financing activities

 

 

48,602

 

 

 

36,642

 

Net (decrease) increase in cash, cash equivalents, and restricted cash

 

 

(35,864

)

 

 

7,013

 

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

 

 

104,702

 

 

 

93,314

 

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

 

$

68,838

 

 

$

100,327

 

Supplemental cash flow information:

 

 

 

 

 

 

Cash paid for interest

 

$

3,308

 

 

$

1,569

 

Cash received for interest

 

$

636

 

 

$

18

 

Noncash financing and investing activities:

 

 

 

 

 

 

Common stock issued for settlement of senior convertible notes

 

$

 

 

$

7,452

 

Purchased intangible assets included in accounts payable and accrued expenses

 

$

 

 

$

556

 

Deferred offering and issuance costs included in accounts payable and accrued expenses

 

$

 

 

$

50

 

Deferred offering costs reclassified to additional-paid-in capital

 

$

77

 

 

$

30

 

Reclass of warrant liability to additional paid in capital

 

$

71

 

 

$

298

 

Reclass of deferred asset associated with issuance of loan payable to debt discount

 

$

206

 

 

$

390

 

Settlement of liability for exercise of warrants

 

$

 

 

$

805

 

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

3


Table of Contents

 

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. The FDA has accepted the Company's submission of a supplemental New Drug Application to expand the label of BREXAFEMME to include the prevention of recurrent VVC. The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act target decision date as November 30, 2022.

In October 2022, the Company announced that it is actively pursuing a U.S. commercialization partner to out-license BREXAFEMME in order to refocus its resources on the clinical development of ibrexafungerp for severe, hospital-based indications. As a result, the Company has begun to wind down its promotional activities associated with BREXAFEMME, while keeping BREXAFEMME on the market and available to patients. Additionally, the Company will conclude the partnership with its contracted commercial sales partner, Amplity Health ("Amplity"), which is expected to conclude on November 30, 2022, and the Company will undertake a workforce reduction.

The Company has incurred significant losses and negative cash flows from operations since its initial public offering in May 2014 and expects to continue to incur losses and negative cash flows for the foreseeable future. As a result, the Company had an accumulated deficit of $407.9 million at September 30, 2022 and limited capital resources to fund ongoing operations. These capital resources primarily comprised cash and cash equivalents and short-term investments of $96.1 million at September 30, 2022. 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 ibrexafungerp; (4) its ability to secure a commercialization partner in the U.S. to out-license BREXAFEMME 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 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.

New Jersey Technology Business Tax Certificate Transfer (NOL) Program

The New Jersey Technology Business Tax Certificate Transfer (NOL) program, administered by the New Jersey Economic Development Authority, enables approved biotechnology companies to sell their unused net operating losses (“NOLs”) and research and development tax credits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. For the nine months ended September 30, 2022, the Company recognized a $4.7 million income tax benefit for the sale of a portion of the Company’s unused New Jersey NOLs and research and development credits.

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, 2022, 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

4


Table of Contents

 

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 29, 2022.

Use of Estimates

The preparation of unaudited condensed consolidated financial statements in conformity with US 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 periods. Actual results could differ from those estimates. Significant estimates and judgements 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.

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, 2021, except as described below.

Short-Term Investments

The Company's held-to-maturity short-term investments in U.S. government securities are carried at amortized cost and any premiums or discounts are amortized or accreted through the maturity date of the investment. Any impairment that is not deemed to be temporary is recognized in the period identified.

Basic and Diluted Net Loss per Share of Common Stock

The Company calculates net loss per common share in accordance with ASC 260, Earnings Per Share. Basic net loss per common share for the three and nine months ended September 30, 2022 and 2021 was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Per ASC 260, Earnings Per Share, the weighted average number of common shares outstanding utilized for determining the basic net loss per common share for the three and nine months ended September 30, 2022 includes the outstanding pre-funded warrants to purchase 11,666,667 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 and nine months ended September 30, 2021. Diluted net loss per common share for the three and nine months ended September 30, 2022 and 2021 was determined as follows (in thousands, except share and per share amounts):

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss

$

(29,584

)

 

$

(605

)

 

$

(48,380

)

 

$

(3,623

)

Dilutive effect of warrant liability

 

 

 

 

 

 

 

 

 

 

(15,719

)

Dilutive effect of convertible debt

 

 

 

 

(988

)

 

 

 

 

 

 

Net loss allocated to common shares

$

(29,584

)

 

$

(1,593

)

 

$

(48,380

)

 

$

(19,342

)

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding – basic

 

47,503,821

 

 

 

26,616,628

 

 

 

40,965,908

 

 

 

26,147,658

 

Dilutive effect of warrant liability

 

 

 

 

 

 

 

 

 

 

178,348

 

Dilutive effect of convertible debt

 

 

 

 

1,138,200

 

 

 

 

 

 

 

Weighted average common shares outstanding – diluted

 

47,503,821

 

 

 

27,754,828

 

 

 

40,965,908

 

 

 

26,326,006

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share – diluted

$

(0.62

)

 

$

(0.06

)

 

$

(1.18

)

 

$

(0.73

)

 

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Table of Contents

 

The following potentially dilutive shares of common stock have not been included in the computation of diluted net loss per share for the three and nine months ended September 30, 2022 and 2021, as the result would be anti-dilutive:

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Outstanding stock options

 

2,125,002

 

 

 

1,643,506

 

 

 

2,125,002

 

 

 

1,643,506

 

Outstanding restricted stock units

 

990,015

 

 

 

149,134

 

 

 

990,015

 

 

 

149,134

 

Warrants to purchase common stock associated with March 2018 public offering – Series 2

 

798,810

 

 

 

798,810

 

 

 

798,810

 

 

 

798,810

 

Warrants to purchase common stock associated with December 2019 public offering

 

 

 

 

4,472,205

 

 

 

 

 

 

4,472,205

 

Warrants to purchase common stock associated with December 2020 public offering - Series 1

 

 

 

 

6,439,866

 

 

 

 

 

 

 

Warrants to purchase common stock associated with December 2020 public offering - Series 2

 

6,800,000

 

 

 

6,800,000

 

 

 

6,800,000

 

 

 

6,800,000

 

Warrants to purchase common stock associated with April 2022 Public Offering