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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

COMMISSION FILE NUMBER 001-36279

CARA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

75-3175693

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

4 Stamford Plaza

107 Elm Street, 9th Floor

Stamford, Connecticut

06902

(Address of registrant’s principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (203) 406-3700

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

CARA

The Nasdaq Stock Market LLC

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.

The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of November 3, 2022 was: 53,733,607.

CARA THERAPEUTICS, INC.

INDEX TO FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2022

PART I –FINANCIAL INFORMATION

PAGE

NUMBER

Item 1.

Financial Statements (Unaudited):

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

1

Condensed Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2022 and 2021

2

Condensed Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2022 and 2021

3

Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2022 and 2021

5

Notes to Condensed Financial Statements

6

Item 2.

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

35

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

62

Item 4.

Controls and Procedures

63

PART II – OTHER INFORMATION

Item 1.

Legal Proceedings

64

Item 1A.

Risk Factors

64

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

66

Item 3.

Defaults Upon Senior Securities

66

Item 4.

Mine Safety Disclosures

66

Item 5.

Other Information

66

Item 6.

Exhibits

67

SIGNATURES

68

PART I

FINANCIAL INFORMATION

Item 1.Financial Statements.

CARA THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(amounts in thousands, excluding share and per share data)

(unaudited)

    

September 30, 2022

    

December 31, 2021

Assets

 

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

42,806

$

13,453

Marketable securities

 

112,806

 

153,582

Accounts receivable, net - related party

9,623

Inventory, net

1,835

2,584

Income tax receivable

 

697

 

697

Other receivables

 

451

 

455

Prepaid expenses

 

18,562

 

2,519

Total current assets

 

186,780

 

173,290

Operating lease right-of-use assets

1,918

2,973

Marketable securities, non-current

 

23,916

 

69,754

Property and equipment, net

 

487

 

631

Restricted cash

 

408

 

408

Total assets

$

213,509

$

247,056

Liabilities and stockholders’ equity

 

 

  

Current liabilities:

 

 

  

Accounts payable and accrued expenses

$

26,316

$

15,861

Operating lease liabilities, current

 

1,876

 

1,755

Total current liabilities

 

28,192

 

17,616

Operating lease liabilities, non-current

497

1,918

Commitments and contingencies (Note 16)

 

 

Stockholders’ equity:

 

 

  

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

 

 

Common stock; $0.001 par value; 100,000,000 shares authorized at September 30, 2022 and December 31, 2021, 53,733,607 shares and 53,480,812 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

53

 

53

Additional paid-in capital

 

722,808

 

708,585

Accumulated deficit

 

(535,893)

 

(480,758)

Accumulated other comprehensive loss

 

(2,148)

 

(358)

Total stockholders’ equity

 

184,820

 

227,522

Total liabilities and stockholders’ equity

$

213,509

$

247,056

See Notes to Condensed Financial Statements.

1

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

(amounts in thousands, excluding share and per share data)

(unaudited)

Three Months Ended

Nine Months Ended

    

September 30, 2022

    

September 30, 2021

    

September 30, 2022

    

September 30, 2021

    

Revenue:

Collaborative revenue

$

7,443

$

$

15,446

$

706

License and milestone fees

20,031

15,000

21,223

Commercial supply revenue

 

3,370

 

 

8,160

 

Clinical compound revenue

 

 

241

 

 

278

Total revenue

 

10,813

 

20,272

 

38,606

 

22,207

Operating expenses:

 

  

 

  

 

  

 

  

Cost of goods sold

3,055

5,136

Research and development

 

24,691

 

15,514

 

65,869

 

59,870

General and administrative

 

6,912

 

5,882

 

23,829

 

17,898

Total operating expenses

 

34,658

 

21,396

 

94,834

 

77,768

Operating loss

 

(23,845)

 

(1,124)

 

(56,228)

 

(55,561)

Other income, net

 

665

 

111

 

1,093

 

502

Net loss

$

(23,180)

$

(1,013)

$

(55,135)

$

(55,059)

Net loss per share:

 

 

  

 

  

 

  

Basic and Diluted

$

(0.43)

$

(0.02)

$

(1.03)

$

(1.10)

Weighted average shares:

 

 

 

  

 

Basic and Diluted

 

53,726,123

 

50,114,710

 

53,616,753

 

50,031,615

Other comprehensive income (loss), net of tax of $0:

 

  

 

 

  

 

  

Change in unrealized gains (losses) on available-for-sale marketable securities

 

(101)

 

6

 

(1,790)

 

(72)

Total comprehensive loss

$

(23,281)

$

(1,007)

$

(56,925)

$

(55,131)

See Notes to Condensed Financial Statements.

2

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(amounts in thousands except share and per share data)

(unaudited)

Accumulated

Common Stock

Additional

Stock

Other

Total

Common Stock

Subscribed in Private Offering

Paid-In

Subscription

Accumulated

Comprehensive

Stockholders’

    

Shares

    

Amount

    

Shares

    

Amount

    

Capital

    

Receivable

    

Deficit

    

Loss

    

Equity

Balance at December 31, 2021

53,480,812

$

53

$

$

708,585

$

$

(480,758)

$

(358)

$

227,522

Stock-based compensation expense

4,266

4,266

Shares issued upon exercise of stock options

470

3

3

Shares issued upon vesting of restricted stock units

109,943

1,438

1,438

Net loss

 

 

 

 

 

 

(27,749)

 

 

(27,749)

Other comprehensive loss

 

 

 

 

 

 

 

(1,365)

 

(1,365)

Balance at March 31, 2022

53,591,225

$

53

$

$

714,292

$

$

(508,507)

$

(1,723)

$

204,115

Stock-based compensation expense

 

 

 

4,232

 

 

 

 

4,232

Shares issued upon exercise of stock options

30,000

 

 

 

182

 

 

 

 

182

Shares issued upon vesting of restricted stock units

89,075

 

 

 

423

 

 

 

 

423

Net loss

 

 

 

 

 

(4,206)

 

 

(4,206)

Other comprehensive loss

 

 

 

 

 

 

(324)

 

(324)

Balance at June 30, 2022

53,710,300

$

53

$

$

719,129

$

$

(512,713)

$

(2,047)

$

204,422

Stock-based compensation expense

3,520

3,520

Shares issued upon exercise of stock options

15,807

104

104

Shares issued upon vesting of restricted stock units

7,500

55

55

Net loss

(23,180)

(23,180)

Other comprehensive loss

(101)

(101)

Balance at September 30, 2022

53,733,607

$

53

$

$

722,808

$

$

(535,893)

$

(2,148)

$

184,820

3

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY (continued)

(amounts in thousands except share and per share data)

(unaudited)

Accumulated

Common Stock

Additional

Stock

Other

Total

Common Stock

Subscribed in Private Offering

Paid-In

Subscription

Accumulated

Comprehensive

Stockholders’

    

Shares

    

Amount

    

Shares

    

Amount

    

Capital

    

Receivable

    

Deficit

    

Income (Loss)

    

Equity

Balance at December 31, 2020

49,872,213

$

50

$

$

641,195

$

$

(392,317)

$

73

$

249,001

Stock-based compensation expense

 

 

 

 

2,744

 

 

 

 

2,744

Shares issued upon exercise of stock options

 

45,035

 

 

 

688

 

 

 

 

688

Shares issued upon vesting of restricted stock units

109,419

1,388

1,388

Net loss

 

 

 

 

 

 

(23,301)

 

 

(23,301)

Other comprehensive loss

 

 

 

 

 

 

 

(61)

 

(61)

Balance at March 31, 2021

50,026,667

$

50

$

$

646,015

$

$

(415,618)

$

12

$

230,459

Stock-based compensation expense

 

 

 

3,376

 

 

 

 

3,376

Shares issued upon exercise of stock options

25,494

 

 

 

293

 

 

 

 

293

Shares issued upon vesting of restricted stock units

36,000

100

100

Net loss

 

 

 

 

 

(30,745)

 

 

(30,745)

Other comprehensive loss

 

 

 

 

 

 

(17)

 

(17)

Balance at June 30, 2021

50,088,161

$

50

$

$

649,784

$

$

(446,363)

$

(5)

$

203,466

Subscription of common stock in Vifor stock purchase ($15.23 per share)

3,282,391

3

44,966

(44,969)

Stock-based compensation expense

3,487

3,487

Shares issued upon exercise of stock options

43,825

339

339

Shares issued upon vesting of restricted stock units

44,002

906

906

Net loss

(1,013)

(1,013)

Other comprehensive income

6

6

Balance at September 30, 2021

50,175,988

$

50

3,282,391

$

3

$

699,482

$

(44,969)

$

(447,376)

$

1

$

207,191

See Notes to Condensed Financial Statements.

4

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(amounts in thousands)

(unaudited)

Nine Months Ended

    

September 30, 2022

    

September 30, 2021

    

Operating activities

 

  

 

  

Net loss

$

(55,135)

$

(55,059)

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

 

  

 

Stock-based compensation expense

 

13,933

 

12,001

Depreciation and amortization

 

187

 

186

Amortization expense component of lease expense

 

1,055

 

969

Amortization of available-for-sale marketable securities, net

498

590

Realized gain on sale of available-for-sale marketable securities

 

 

(39)

Realized gain on sale of property and equipment

 

 

(70)

Changes in operating assets and liabilities:

 

 

Accounts receivable, net - related party

(9,623)

Inventory, net

749

Income tax receivable

810

Other receivables

 

4

 

(19,793)

Prepaid expenses

 

(16,043)

 

5,818

Accounts payable and accrued expenses

 

10,455

 

(3,069)

Operating lease liabilities

(1,300)

(1,186)

Net cash used in operating activities

 

(55,220)

 

(58,842)

Investing activities

 

  

 

  

Proceeds from maturities of available-for-sale marketable securities

 

162,185

 

134,220

Proceeds from redemptions of available-for-sale marketable securities, at par

13,500

Proceeds from sale of available-for-sale marketable securities

 

 

10,029

Purchases of available-for-sale marketable securities

 

(77,858)

 

(108,989)

Purchases of property and equipment

 

(43)

 

Proceeds from sale of property and equipment

70

Net cash provided by investing activities

 

84,284

 

48,830

Financing activities

 

 

  

Proceeds from the exercise of stock options

 

289

 

1,320

Net cash provided by financing activities

 

289

 

1,320

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

 

29,353

 

(8,692)

Cash, cash equivalents and restricted cash at beginning of period

 

13,861

 

32,091

Cash, cash equivalents and restricted cash at end of period