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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, 2021

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 4, 2021 was: 53,458,679.

Table of Contents

CARA THERAPEUTICS, INC.

INDEX TO FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2021

PART I –FINANCIAL INFORMATION

PAGE

NUMBER

Item 1.

Financial Statements (Unaudited):

Condensed Balance Sheets as of September 30, 2021 and December 31, 2020

1

Condensed Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2021 and 2020

2

Condensed Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2021 and 2020

3

Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020

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

58

Item 4.

Controls and Procedures

59

PART II – OTHER INFORMATION

Item 1.

Legal Proceedings

60

Item 1A.

Risk Factors

60

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

104

Item 3.

Defaults Upon Senior Securities

104

Item 4.

Mine Safety Disclosures

104

Item 5.

Other Information

104

Item 6.

Exhibits

105

SIGNATURES

107

Table of Contents

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, 2021

    

December 31, 2020

Assets

 

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

22,991

$

31,683

Marketable securities

 

121,203

 

149,242

Income tax receivable

 

697

 

1,507

Other receivables

 

20,350

 

557

Prepaid expenses

 

6,258

 

12,076

Total current assets

 

171,499

 

195,065

Operating lease right-of-use assets

3,310

4,279

Marketable securities, non-current

 

49,221

 

70,565

Property and equipment, net

 

654

 

840

Restricted cash

 

408

 

408

Total assets

$

225,092

$

271,157

Liabilities and stockholders’ equity

 

 

  

Current liabilities:

 

 

  

Accounts payable and accrued expenses

$

13,812

$

16,881

Operating lease liabilities, current

 

1,716

 

1,602

Total current liabilities

 

15,528

 

18,483

Operating lease liabilities, non-current

2,373

3,673

Commitments and contingencies (Note 15)

 

 

Stockholders’ equity:

 

 

  

Preferred stock; $0.001 par value; 5,000,000 shares authorized at September 30, 2021 and December 31, 2020, zero shares issued and outstanding at September 30, 2021 and December 31, 2020

 

 

Common stock; $0.001 par value; 100,000,000 shares authorized at September 30, 2021 and December 31, 2020, 50,175,988 shares and 49,872,213 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

 

50

 

50

Common stock subscribed in Vifor stock purchase, or Private Offering; $0.001 par value; 3,282,391 shares at September 30, 2021

3

Additional paid-in capital

 

699,482

 

641,195

Stock subscription receivable

(44,969)

Accumulated deficit

 

(447,376)

 

(392,317)

Accumulated other comprehensive income

 

1

 

73

Total stockholders’ equity

 

207,191

 

249,001

Total liabilities and stockholders’ equity

$

225,092

$

271,157

See Notes to Condensed Financial Statements.

1

Table of Contents

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, 2021

    

September 30, 2020

    

September 30, 2021

    

September 30, 2020

    

Revenue:

License and milestone fees

$

20,031

$

9,257

$

21,223

$

22,377

Collaborative revenue

 

 

 

706

 

Clinical compound revenue

 

241

 

9

 

278

 

616

Total revenue

 

20,272

 

9,266

 

22,207

 

22,993

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

 

15,514

 

21,067

 

59,870

 

80,711

General and administrative

 

5,882

 

5,219

 

17,898

 

15,187

Total operating expenses

 

21,396

 

26,286

 

77,768

 

95,898

Operating loss

 

(1,124)

 

(17,020)

 

(55,561)

 

(72,905)

Other income, net

 

111

 

379

 

502

 

1,970

Loss before benefit from income taxes

 

(1,013)

 

(16,641)

 

(55,059)

 

(70,935)

Benefit from income taxes

 

 

132

 

 

436

Net Loss

$

(1,013)

$

(16,509)

$

(55,059)

$

(70,499)

Net Loss per share:

 

 

  

 

  

 

  

Basic and Diluted

$

(0.02)

$

(0.35)

$

(1.10)

$

(1.51)

Weighted average shares:

 

 

 

  

 

Basic and Diluted

 

50,114,710

 

46,885,424

 

50,031,615

 

46,803,659

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

 

  

 

 

  

 

  

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

 

6

 

(272)

 

(72)

 

193

Total comprehensive loss

$

(1,007)

$

(16,781)

$

(55,131)

$

(70,306)

See Notes to Condensed Financial Statements.

2

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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

    

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

3

Table of Contents

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, 2019

46,720,225

$

47

$

$

587,223

$

$

(400,727)

$

170

$

186,713

Stock-based compensation expense

 

 

 

 

2,846

 

 

 

 

2,846

Shares issued upon exercise of stock options

 

7,500

 

 

 

75

 

 

 

 

75

Net loss

 

 

 

 

 

 

(28,922)

 

 

(28,922)

Other comprehensive loss

 

 

 

 

 

 

 

(238)

 

(238)

Balance at March 31, 2020

46,727,725

$

47

$

$

590,144

$

$

(429,649)

$

(68)

$

160,474

Stock-based compensation expense

 

 

 

2,993

 

 

 

 

2,993

Shares issued upon exercise of stock options

16,846

 

 

 

201

 

 

 

 

201

Shares issued upon vesting of restricted stock units

119,834

1,625

1,625

Net loss

 

 

 

 

 

(25,068)

 

 

(25,068)

Other comprehensive income

 

 

 

 

 

 

703

 

703

Balance at June 30, 2020

46,864,405

$

47

$

$

594,963

$

$

(454,717)

$

635

$

140,928

Stock-based compensation expense

3,305

3,305

Shares issued upon exercise of stock options

28,147

395

395

Net loss

(16,509)

(16,509)

Other comprehensive loss

(272)

(272)

Balance at September 30, 2020

46,892,552

$

47

$

$

598,663

$

$

(471,226)

$

363

$

127,847

See Notes to Condensed Financial Statements.

4

Table of Contents

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(amounts in thousands)

(unaudited)

Nine Months Ended

    

September 30, 2021

    

September 30, 2020

    

Operating activities

 

  

 

  

Net loss

$

(55,059)

$

(70,499)

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

 

  

 

Stock-based compensation expense

 

12,001

 

10,770

Depreciation and amortization

 

186

 

147

Amortization expense component of lease expense

 

969

 

496

Amortization of available-for-sale marketable securities, net

590

28

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

 

(39)

 

(126)

Realized gain on sale of property and equipment

 

(70)

 

Deferred revenue

 

 

(21,751)

Changes in operating assets and liabilities:

 

 

Income tax receivable

 

810

 

(436)

Other receivables

 

(19,793)

 

509

Prepaid expenses

 

5,818

 

(1,391)

Accounts payable and accrued expenses

 

(3,069)

 

(4,608)

Operating lease liabilities

(1,186)

(714)

Net cash used in operating activities

 

(58,842)

 

(87,575)

Investing activities

 

  

 

  

Proceeds from maturities of available-for-sale marketable securities

 

134,220

 

119,895

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

13,500

22,035

Proceeds from sale of available-for-sale marketable securities

 

10,029

 

23,148

Purchases of available-for-sale marketable securities

 

(108,989)

 

(21,016)

Proceeds from sale of property and equipment

 

70

 

Purchases of property and equipment

(182)

Net cash provided by investing activities

 

48,830

 

143,880

Financing activities

 

  

 

  

Proceeds from the exercise of stock options

 

1,320

 

671

Net cash provided by financing activities

 

1,320

 

671

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

 

(8,692)

 

56,976

Cash, cash equivalents and restricted cash at beginning of period

 

32,091

 

18,713

Cash, cash equivalents and restricted cash at end of period

$

23,399

$

75,689

Noncash investing and financing activities

Stock subscription receivable from Vifor

$

44,969

$

See Notes to Condensed Financial Statements.

5

Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

1. Business

Cara Therapeutics, Inc., or the Company, is an early commercial-stage biopharmaceutical company formed on July 2, 2004. The Company is focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors. The Company’s primary activities to date have been organizing and staffing the Company, developing its product candidates and raising capital.

On August 23, 2021, the Company received U.S. Food and Drug Administration, or FDA, approval for KORSUVATM (CR845/difelikefalin) injection, or KORSUVA injection, for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.

As of September 30, 2021, the Company had raised aggregate net proceeds of approximately $519,600 from several rounds of equity financing, including its initial public offering, or IPO, which closed in February 2014 and four follow-on public offerings of common stock, which closed in July 2019, July 2018, April 2017 and August 2015, respectively, and the issuance of convertible preferred stock and debt prior to the IPO. The Company had also earned approximately $224,100 under its license agreements for CR845/difelikefalin, primarily with Vifor (International) Ltd., or Vifor, Vifor Fresenius Medical Care Renal Pharma Ltd., or VFMCRP, Maruishi Pharmaceutical Co. Ltd., or Maruishi, and Chong Kun Dang Pharmaceutical Corp., or CKDP, and an earlier product candidate for which development efforts ceased in 2007. In October 2021, the Company received net proceeds of $44,969 from the issuance and sale of 3,282,391 shares of the Company’s common stock to Vifor in connection with U.S. regulatory approval for KORSUVA injection in August 2021 (see Notes 9, Stockholders’ Equity and 16, Subsequent Events). Additionally, in October 2020, the Company received net proceeds of $38,449 from the issuance and sale of 2,939,552 shares of the Company’s common stock to Vifor in connection with the Company’s license agreement with Vifor. Furthermore, in May 2018, the Company received net proceeds of $14,556 from the issuance and sale of 1,174,827 shares of the Company’s common stock to Vifor in connection with the Company’s license agreement with VFMCRP (see Note 10, Collaboration and Licensing Agreements).

As of September 30, 2021, the Company had unrestricted cash and cash equivalents and marketable securities of $193,415 and an accumulated deficit of $447,376. The Company has incurred substantial net losses and negative cash flows from operating activities in nearly every fiscal period since inception and expects this trend to continue for the foreseeable future. The Company recognized net losses of $1,013 and $16,509 for the three months ended September 30, 2021 and 2020, respectively, and $55,059 and $70,499 for the nine months ended September 30, 2021 and 2020, respectively, and had net cash used in operating activities of $58,842 and $87,575 for the nine months ended September 30, 2021 and 2020, respectively.

The Company is subject to risks common to other life science companies including, but not limited to, uncertainty of product development and commercialization, lack of marketing and sales history, development by its competitors of new technological innovations, dependence on key personnel, market acceptance of products, product liability, protection of proprietary technology, ability to raise additional financing, and compliance with FDA and other government regulations. If the Company does not successfully commercialize KORSUVA injection or any of its product candidates, it will be unable to generate recurring product revenue or achieve profitability.

2. Basis of Presentation

The unaudited interim condensed financial statements included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission, or SEC. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States of America, or GAAP. In the opinion of

6

Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

management, these unaudited interim financial statements reflect all adjustments, consisting primarily of normal recurring accruals, necessary for a fair presentation of results for the periods presented. The results of operations for interim periods are not necessarily indicative of the results for the full year. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by SEC rules and regulations; however, the Company believes that the disclosures are adequate to make the information presented not misleading. The condensed balance sheet data as of December 31, 2020 were derived from audited financial statements, but do not include all disclosures required by GAAP. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.

Use of Estimates

The preparation of financial statements in conformity with 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 as well as the reported amounts of revenues and expenses during the reporting period. The more significant estimates include the fair value of marketable securities that are classified as level 2 of the fair value hierarchy, the periods over which certain revenues will be recognized, including licensing and collaborative revenue recognized from non-refundable up-front and milestone payments, the determination of prepaid research and development, or R&D, clinical costs and accrued research projects, the amount of non-cash compensation costs related to share-based payments to employees and non-employees and the periods over which those costs are expensed, the incremental borrowing rate used in lease calculations and the likelihood of realization of deferred tax assets.

The ongoing COVID-19 pandemic has interrupted business operations across the globe. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these condensed financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the reported amounts of assets and liabilities or the disclosure of contingent assets and liabilities. These estimates, however, may change as new events occur and additional information is obtained, and are recognized in the condensed financial statements as soon as they become known.

Actual results could differ materially from the Company’s estimates and assumptions.

Significant Accounting Policies

There have been no material changes to the significant accounting policies previously disclosed in Note 2 to the Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, except for the recent adoption of new accounting pronouncements as disclosed below.

Accounting Pronouncements Recently Adopted

In December 2019, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2019-12, Income Taxes (Topic 740), or ASU 2019-12, which removes specific exceptions to the general principles in Topic 740. ASU 2019-12 eliminates the need for an organization to analyze whether the following apply in a given period: (1) exception to the incremental approach for intra-period tax allocation; (2) exceptions to accounting for basis differences when there are ownership changes in foreign investments; and (3) exception to the general methodology for calculating income taxes in an interim period when a year-to-date loss exceeds the anticipated loss. ASU 2019-12 also simplifies the accounting for income taxes for: (i) franchise taxes that are partially based on income; (ii) transactions with a government that result in a step up in the tax basis of goodwill; (iii) separate financial statements

7

Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

of legal entities that are not subject to tax; and (iv) enacted changes in tax laws in interim periods. The amendments in ASU 2019-12 are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The amendments in ASU 2019-12 related to separate financial statements of legal entities that are not subject to tax should be applied on a retrospective basis for all periods presented. The amendments related to changes in ownership of foreign equity method investments or foreign subsidiaries should be applied on a modified retrospective basis through a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption. The amendments related to franchise taxes that are partially based on income should be applied on either a retrospective basis for all periods presented or a modified retrospective basis through a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption. All other amendments should be applied on a prospective basis. The Company adopted ASU 2019-12 on January 1, 2021 and it did not have a material effect on its results of operations, financial position, and cash flows due to the full valuation allowance recorded.

3. Available-for-Sale Marketable Securities

As of September 30, 2021 and December 31, 2020, the Company’s available-for-sale marketable securities consisted of debt securities issued by the U.S. Treasury, U.S. government-sponsored entities and investment grade institutions as well as municipal bonds.

The following tables summarize the Company’s available-for-sale marketable securities by major type of security as of September 30, 2021 and December 31, 2020:

As of September 30, 2021

Gross Unrealized

Estimated Fair

Type of Security

    

Amortized Cost

    

Gains

    

Losses

    

Value

U.S. Treasury securities

$

10,067

$

3

$

$

10,070

U.S. government agency obligations

 

17,046

 

3

 

(5)

 

17,044

Corporate bonds

 

46,920

 

17

 

(23)

 

46,914

Commercial paper

78,452

6

(4)

78,454

Municipal bonds

 

17,938

 

19

 

(15)

 

17,942

Total available-for-sale marketable securities

$

170,423

$

48

$

(47)

$

170,424

As of December 31, 2020

Gross Unrealized

Estimated Fair

Type of Security

    

Amortized Cost

    

Gains