Cara Therapeutics
Cara Therapeutics, Inc. (Form: 10-Q, Received: 11/02/2017 17:14:06)
Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

 

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

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2017

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   (I.R.S. Employer
incorporation or organization)   Identification No.)

4 Stamford Plaza

107 Elm Street 9 th Floor

Stamford, Connecticut

  06902
(Address of registrant’s principal executive offices)   (Zip Code)

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

 

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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 definition 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 October 27, 2017 was: 32,608,485.


Table of Contents

CARA THERAPEUTICS, INC.

INDEX TO FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2017

 

 

    PART I – FINANCIAL INFORMATION       
         PAGE
NUMBER
 
Item 1.   Financial Statements (Unaudited):   
  Condensed Balance Sheets as of September 30, 2017 and December 31, 2016      1  
  Condensed Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2017 and 2016      2  
  Condensed Statements of Stockholders’ Equity for the Nine Months Ended September 30, 2017 and 2016      3  
  Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2017 and 2016      4  
  Notes to Condensed Financial Statements      5  
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations      21  
Item 3.   Quantitative and Qualitative Disclosures About Market Risk      36  
Item 4.   Controls and Procedures      37  
  PART II – OTHER INFORMATION   
Item 1.   Legal Proceedings      38  
Item 1A   Risk Factors      38  
Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds      38  
Item 3.   Defaults Upon Senior Securities      38  
Item 4.   Mine Safety Disclosures      38  
Item 5.   Other Information      38  
Item 6.   Exhibits      39  
  SIGNATURES      40  

 


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, 2017     December 31, 2016  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 11,792     $ 12,092  

Marketable securities

     91,190       46,184  

Income tax receivable

     705       852  

Other receivables

     97       87  

Prepaid expenses

     1,492       1,530  

Restricted cash, current

     700       700  
  

 

 

   

 

 

 

Total current assets

     105,976       61,445  

Property and equipment, net

     1,302       1,614  

Restricted cash

     769       769  
  

 

 

   

 

 

 

Total assets

   $ 108,047     $ 63,828  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable and accrued expenses

   $ 7,272     $ 11,533  
  

 

 

   

 

 

 

Total current liabilities

     7,272       11,533  

Deferred lease obligation

     1,701       1,570  

Commitments and contingencies (Note  14)

     —         —    

Stockholders’ equity:

    

Preferred stock; $0.001 par value; 5,000,000 shares authorized at September 30, 2017 and December 31, 2016, zero shares issued and outstanding at September 30, 2017 and December 31, 2016

     —         —    

Common stock; $0.001 par value; 100,000,000 shares authorized at September 30, 2017 and December 31, 2016, 32,608,485 shares and 27,296,863 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively

     33       27  

Additional paid-in capital

     305,165       212,866  

Accumulated deficit

     (206,164     (162,171

Accumulated other comprehensive income

     40       3  
  

 

 

   

 

 

 

Total stockholders’ equity

     99,074       50,725  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 108,047     $ 63,828  
  

 

 

   

 

 

 

See Notes to Condensed Financial Statements.

 

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CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

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

(unaudited)

 

     Three Months Ended September 30,     Nine Months Ended September 30,  
     2017     2016     2017     2016  

Revenue:

        

License and milestone fees

   $ —       $ —       $ 530     $ —    

Collaborative revenue

     —         —         313       —    

Clinical compound revenue

     —         —         68       86  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     —         —         911       86  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Research and development

     9,151       9,671       36,948       28,976  

General and administrative

     3,805       2,102       8,877       7,195  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     12,956       11,773       45,825       36,171  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (12,956     (11,773     (44,914     (36,085

Other income

     367       176       788       498  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before benefit from income taxes

     (12,589     (11,597     (44,126     (35,587

Benefit from income taxes

     145       55       178       279  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (12,444   $ (11,542   $ (43,948   $ (35,308
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share -Basic and Diluted

   $ (0.38   $ (0.42   $ (1.43   $ (1.29
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares:

        

Basic and Diluted

     32,591,550       27,282,863       30,729,752       27,275,133  
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income, net of tax of $0:

        

Unrealized gains (losses) on available-for-sale marketable securities

     53       (21     37       55  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss

   $ (12,391   $ (11,563   $ (43,911   $ (35,253
  

 

 

   

 

 

   

 

 

   

 

 

 

See Notes to Condensed Financial Statements.

 

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CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(amounts in thousands except share and per share data)

(unaudited)

 

    

 

Common Stock

     Additional
Paid-In
Capital
     Accumulated
Deficit
    Accumulated
Other

Comprehensive
Income (Loss)
    Total
Stockholders’
Equity
 
     Shares      Amount            

Balance at December 31, 2015

     27,254,863      $ 27      $ 209,943      $ (104,891   $ (35   $ 105,044  

Stock-based compensation expense

     —          —          1,971        —         —         1,971  

Shares issued upon exercise of stock options

     28,000        —          40        —         —         40  

Net loss

     —          —          —          (35,308     —         (35,308

Other comprehensive income

     —          —          —          —         55       55  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance at September 30, 2016

     27,282,863      $ 27      $ 211,954      $ (140,199   $ 20     $ 71,802  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 
    

 

Common Stock

     Additional
Paid-In
Capital
     Accumulated
Deficit
    Accumulated
Other
Comprehensive
Income (Loss)
    Total
Stockholders’
Equity
 
     Shares      Amount            

Balance at December 31, 2016

     27,296,863      $ 27      $ 212,866      $ (162,171   $ 3     $ 50,725  

Sale of common stock in a follow-on public offering ($18.00 per share), net of underwriting discounts and commissions and offering expenses of $5,891

     5,117,500        5        86,219        —         —         86,224  

Stock-based compensation expense

     —          —          4,046        —         —         4,046  

Modification of equity awards

     —          —          474        —         —         474  

Shares issued upon exercise of stock options

     194,122        1        1,515        —         —         1,516  

Cumulative effect adjustment upon adoption of ASU 2016-09

     —          —          45        (45     —         —    

Net loss

     —          —          —          (43,948       (43,948

Other comprehensive income

     —          —          —          —         37       37  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance at September 30, 2017

     32,608,485      $ 33      $ 305,165      $ (206,164   $ 40     $ 99,074  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

See Notes to Condensed Financial Statements.

 

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CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(amounts in thousands)

(unaudited)

 

     Nine Months Ended September 30,  
     2017     2016  

Operating activities

    

Net loss

   $ (43,948   $ (35,308

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

    

Stock-based compensation expense

     4,046       1,971  

Modification of equity awards

     474       —    

Depreciation and amortization

     370       1,346  

Accretion/amortization on available-for-sale marketable securities

     (356     (183

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

     (4     (12

Realized gain on sale of property and equipment

     (41     —    

Deferred rent costs

     131       (158

Changes in operating assets and liabilities:

    

Income tax receivable

     147       (279

Other receivables

     (10     (35

Prepaid expenses

     38       (3,091

Accounts payable and accrued expenses

     (4,261     1,556  
  

 

 

   

 

 

 

Net cash used in operating activities

     (43,414     (34,193
  

 

 

   

 

 

 

Investing activities

    

Proceeds from maturities of available-for-sale marketable securities

     65,406       59,650  

Proceeds from sale of available-for-sale marketable securities

     5,730       23,368  

Purchases of available-for-sale marketable securities

     (115,745     (57,123

Change in restricted cash

     —         (769

Purchases of property and equipment

     (58     (648

Proceeds from sale of property and equipment

     41       —    
  

 

 

   

 

 

 

Net cash (used in) provided by investing activities

     (44,626     24,478  
  

 

 

   

 

 

 

Financing activities

    

Proceeds from sale of common stock in a follow-on public offering, net of issuance costs

     86,224       —    

Proceeds from the exercise of stock options

     1,516       40  
  

 

 

   

 

 

 

Net cash provided by financing activities

     87,740       40  
  

 

 

   

 

 

 

Net cash decrease for the period

     (300     (9,675

Cash and cash equivalents at beginning of period

     12,092       15,101  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 11,792     $ 5,426  
  

 

 

   

 

 

 

Noncash investing and financing activities

    

Tenant improvements paid by landlord

   $ —       $ 1,094  

See Notes to Condensed Financial Statements.

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

1. Business

Cara Therapeutics, Inc. (the “Company”, “we”, “our” or “us”) is a clinical-stage biopharmaceutical corporation formed on July 2, 2004. The Company is focused on developing and commercializing new chemical entities designed to alleviate pain and 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, including conducting preclinical studies and clinical trials of CR845-based product candidates and raising capital.

As of September 30, 2017, the Company has raised aggregate net proceeds of approximately $291,100 from several rounds of equity financing, including its initial public offering, or IPO, which closed in February 2014 and two follow-on public offerings of common stock, which closed in April 2017 and August 2015, respectively, and the issuance of convertible preferred stock and debt prior to the IPO. In addition, the Company received approximately $33,500 under its license agreements for CR845, primarily with 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 (see Note 10, Collaborations ).

On April 5, 2017, the Company completed its second follow-on public offering, raising aggregate proceeds of approximately $86,224, net of underwriting discounts and commissions and offering expenses paid by the Company. The offering was conducted pursuant to a shelf registration statement on Form S-3, which was filed on March 13, 2017 and declared effective by the Securities and Exchange Commission, or the SEC, on March 24, 2017 (see Note 9, Stockholders’ Equity ).

As of September 30, 2017, the Company had unrestricted cash and cash equivalents and marketable securities of $102,982 and an accumulated deficit of $206,164. 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 $43,948 and $35,308 and had net cash used in operating activities of $43,414 and $34,193 for the nine months ended September 30, 2017 and 2016, 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 Food and Drug Administration, or FDA, and other government regulations. If the Company does not successfully commercialize 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 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 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 for the year ended December 31, 2016 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, 2016.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires the Company to make estimates and

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

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. Actual results could differ materially from the Company’s estimates and assumptions. Significant estimates include the fair value of marketable securities that are classified as level 2 of the fair value hierarchy, useful lives of fixed assets, 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 and the likelihood of realization of deferred tax assets.

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, 2016.

Accounting Pronouncements Recently Adopted

As of January 1, 2017, the Company adopted Accounting Standards Update, or ASU, No. 2016-09, Improvements to Employee Share-Based Payment Accounting , or ASU 2016-09, which amends Accounting Standards Codification, or ASC, Topic 718 ,  Compensation – Stock Compensation . ASU 2016-09 simplifies several aspects of the accounting for share-based payment transactions, including the accounting for forfeitures, income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Certain of the amendments were applied using a modified retrospective transition method by means of a cumulative-effect adjustment to equity as of January 1, 2017, while other amendments were applied retrospectively, prospectively or using either a prospective or a retrospective transition method. Upon adoption, the Company began to account for forfeitures as they occur rather than estimate forfeiture rates for stock option awards. As a result, the Company recorded a cumulative-effect adjustment to stockholders’ equity of $45 on the date of initial adoption for all stock option awards that were unvested as of that date. In periods subsequent to adoption, a higher expense will be recognized earlier during the respective vesting periods of stock-based awards that are not forfeited. The Company expects that the income tax amendments within ASU 2016-09 will have no impact on its results of operations or cash flows because it is in a net operating loss position with a full valuation allowance against its deferred tax assets.

Recent Accounting Pronouncements Not Yet Adopted

In May 2017, the Financial Accounting Standards Board, or FASB, issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718) – Scope of Modification Accounting , or ASU 2017-09, which clarifies that a change to the terms or conditions of a share-based payment award should be accounted for as a modification only if the fair value, vesting conditions or classification (as equity or liability) of the award changes as a result of the change in terms or conditions. Modification of a share-based payment award may result in the Company recognizing additional compensation expense. ASU 2017-09 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. The Company generally has not modified, and does not expect to frequently modify, the fair value, vesting conditions or classification of its share-based payment awards. As a result, for reporting periods following the adoption of ASU 2017-09, the Company generally does not expect this guidance to have a material effect on its financial position, results of operations or cash flows. However, if and when modifications occur, their effect could be material to the Company’s financial position, results of operations or cash flows (see Note 12, Stock-based Compensation ).

In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805), Clarifying the Definition of a Business, or ASU 2017-01 , that clarifies the definition of a business to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. ASU 2017-01 requires an entity to evaluate if substantially all of the fair value of the gross assets acquired or disposed of is concentrated in a single identifiable asset or a group of similar identifiable assets; if so, the set of transferred assets and activities is not a business. ASU 2017-01 also requires a business to include at least an input and one substantive process that together significantly contribute to the ability to create output and removes the evaluation of whether a market participant could replace missing elements. ASU 2017-01 will be applied prospectively and is effective for annual periods beginning after December 15, 2017 and interim periods within those annual periods. The Company does not expect that the adoption of ASU 2017-01 will have a material effect on its financial position, results of operations or cash flows since it has not and does not expect in the future to acquire or dispose of assets for which the fair value is divided among diverse identifiable assets.

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

 

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) , or ASU 2016-02, which amends the current guidance for the accounting and disclosure of leases (ASC 840) for both lessees and lessors. ASU 2016-02 requires a lessee to recognize in its balance sheet a liability to make lease payments and a right-of-use asset representing its right to use the underlying asset for the lease term. The lease liability will be equal to the present value of lease payments and the right-of-use asset will be based on the lease liability, subject to adjustment such as for initial direct costs. For income statement purposes, the new standard retains a dual model similar to ASC 840, requiring leases to be classified as either operating leases or capital leases. For lessees, operating leases will result in straight-line expense (similar to current accounting by lessees for operating leases under ASC 840) while capital leases will result in a front-loaded expense pattern (similar to current accounting by lessees for capital leases under ASC 840). Lessees and lessors will adopt ASU 2016-02 by using a modified retrospective transition approach. ASU 2016-02 also requires a lessee to disclose qualitative and quantitative information about its leasing arrangements. ASU 2016-02 is effective for interim and annual periods beginning after December 31, 2018, and may be adopted earlier. The Company is continuing to evaluate the impact that ASU 2016-02 will have on its financial statements.

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) , or ASU 2014-09, which changes the principle under which the Company will recognize revenue from contracts with customers from one which requires the Company to satisfy specific criteria before recognizing revenue to one which requires the Company to recognize revenue in an amount that reflects the consideration to which it expects to be entitled in exchange for the transfer of promised goods or services to customers. Topic 606 defines a five-step process to achieve this core principle: (1) identify the contract with the customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

The Company currently recognizes revenue only from a license agreement with Maruishi, or the Maruishi Agreement, and a license agreement with CKDP, or the CKDP Agreement. Under each of these agreements, the Company has recognized revenue from upfront and milestone payments and may earn additional future milestone payments upon the achievement of defined clinical and regulatory events. The Company has also recognized revenue from a sub-license fee under the Maruishi Agreement. Since all defined milestones will not have been achieved and the related revenue will not have been recognized under current GAAP as of the date of adoption of ASU 2014-09, those contracts will be included within the scope of ASU 2014-09.

The Company is currently accounting for the Maruishi Agreement and the CKDP Agreement under ASC 605-25, Multiple-Element Arrangements , or ASC 605-25, and ASC 605-28, Milestone Method , or ASC 605-28. The Company has analyzed the terms and conditions of each of these contracts in light of the guidance under ASC 606, including amendments under ASU 2016-08, 2016-10, 2016-12 and 2016-20, and has concluded that, due to the similarity of the application of the guidance under ASC 605-25 and ASC 605-28 and under ASC 606, as amended, as it relates to revenue recognition for licenses of intellectual property, or IP, as applied to each of these contracts, the distinct performance obligations, transaction prices, amount of the transaction price allocated to the performance obligations and timing and amount of revenue recognition under ASC 606, as amended, will be the same as under ASC 605-25 and ASC 605-28.

In particular, the following aspects of ASC 606, as amended, are the same as those under ASC 605-25 and ASC 605-28 in respect of the Maruishi Agreement and the CKDP Agreement. The Maruishi Agreement has two distinct performance obligations, granting of the license and the R&D services and the CKDP Agreement has one distinct performance obligation, granting of the license. The methodology for determining the relative standalone selling price of the performance obligations and the allocation of the transaction price to the performance obligations is the same under both standards. The licenses granted to the counterparties under these two contracts are deemed to be functional IP for which revenue is recognized at a point in time, which has been determined to be inception of the respective license agreements, the same as under ASC 605. The R&D services under the Maruishi Agreement were performed from inception of the agreement in 2013 through the third quarter of 2015. Accordingly, under ASC 606, as amended, revenue related to the R&D services under the Maruishi Agreement would be recognized proportionately as those services were performed, as it was under ASC 605-25.

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

Although the milestone method guidance under ASC 605-28 no longer applies under ASC 606, as amended, the guidance under ASC 606, as amended, for milestones and sales-based royalties related to licenses of IP is effectively the same as pertains to milestones achieved by the Company and those achieved by the counterparty to each license agreement. In addition, due to the probability, at inception of each of the two license agreements, that revenue recognized related to the achievement of milestones and sales-based royalty payments will be reversed in the future, the constraint on including those potential payments in the transaction price at that time applies under ASC 606, as amended. Under ASC 606, as amended, recognition of revenue for achievement of any milestone and sales-based royalty payment will occur at the time that it becomes probable that those events will be achieved. Application of the guidance under ASC 606, as amended, to the milestones achieved under the Maruishi Agreement and the CKDP Agreement prior to adoption of that standard will not change the amount or timing of revenue recognized under ASC 605 for any reporting period presented at or after the date of adoption of ASC 606, as amended. As a result of the foregoing considerations, the Company has concluded that upon adoption of ASC 606, as amended, there will be no impact on its results of operations, financial position or cash flows for any period presented.

ASU 2014-09, as amended by ASU 2015-14, is effective for annual reporting periods beginning after December 15, 2017, and interim periods within those annual reporting periods. ASU 2014-09 allows for two transition methods: (1) retrospectively to each prior reporting period presented, or (2) using a modified retrospective approach, with the cumulative effect of initially applying ASU 2014-09 recognized as an adjustment to the opening balance of retained earnings at the date of initial adoption. The Company will adopt ASU 2014-09 using the full retrospective method on January 1, 2018.

3. Available-for-Sale Marketable Securities

As of September 30, 2017 and December 31, 2016, the Company’s available-for-sale marketable securities consisted of a money market fund and debt securities issued by U.S. government-sponsored entities and by investment grade institutions. In addition, as of December 31, 2016, the Company’s available-for-sale marketable securities included U.S. Treasury securities.

The following tables summarize the Company’s available-for-sale marketable securities by major type of security as of September 30, 2017 and December 31, 2016:

As of September 30, 2017

 

                                                                                                                   
            Gross Unrealized      Estimated
Fair Value
 

Type of Security

   Amortized Cost      Gains      Losses     

Money market funds

   $ 42,826      $ 49      $ —        $ 42,875  

U.S. government agency obligations

     7,800        1        (1      7,800  

Corporate bonds

     19,368        —          (5      19,363  

Commercial paper

     21,156        —          (4      21,152  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total available-for-sale marketable securities

   $ 91,150      $ 50      $ (10    $ 91,190  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

As of December 31, 2016

 

                                                                                                                   
            Gross Unrealized      Estimated
Fair Value
 

Type of Security

   Amortized Cost      Gains      Losses     

Money market funds

   $ 8,268      $ 8      $ —        $ 8,276  

U.S. Treasury securities

     2,523        —          (1      2,522  

U.S. government agency obligations

     3,501        1        —          3,502  

Corporate bonds

     16,683        —          (6      16,677  

Commercial paper

     15,206        3        (2      15,207  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total available-for-sale marketable securities

   $ 46,181      $ 12      $ (9    $ 46,184  
  

 

 

    

 

 

    

 

 

    

 

 

 

All available-for-sale marketable securities are classified in the Company’s Condensed Balance Sheets as Marketable securities.

The Company classifies its marketable debt securities based on their contractual maturity dates. As of September 30, 2017, the Company’s marketable debt securities mature at various dates through June 2018. The amortized cost and fair values of marketable debt securities by contractual maturity were as follows. The table does not include money market funds that are classified as available-for-sale marketable securities.

 

                                                                                                                   
     As of September 30, 2017      As of December 31, 2016  
Contractual maturity    Amortized Cost      Fair Value      Amortized Cost      Fair Value  

Less than one year

   $ 48,324      $ 48,315      $ 37,913      $ 37,908  
  

 

 

    

 

 

    

 

 

    

 

 

 

During the nine months ended September 30, 2017, the Company sold shares of two investments in commercial paper before their respective maturity dates and shares in a money market fund with a total fair value of $5,730 that were all classified as available-for-sale marketable securities. The cost of the shares of commercial paper and the money market fund that were sold was determined by specific identification. The sales of the investments in commercial paper as well as the sale of the shares of the money market fund each resulted in realized gains, totaling $4.

The following tables show the fair value of the Company’s available-for-sale marketable securities that have unrealized losses and that are deemed to be only temporarily impaired, aggregated by investment category and length of time that the individual investments have been in a continuous unrealized loss position.

As of September 30, 2017

 

     Less than 12 Months     12 Months or Greater      Total  
     Fair Value      Gross
Unrealized
Losses
    Fair Value      Gross
Unrealized
Losses
     Fair Value      Gross
Unrealized
Losses
 

U.S. government agency obligations

   $ 3,498      $ (1   $ —        $ —        $ 3,498      $ (1

Corporate bonds

     18,016        (5     —          —          18,016        (5

Commercial paper

     8,193        (4     —          —          8,193        (4
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 29,707      $ (10   $ —        $ —        $  29,707      $ (10
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

As of December 31, 2016

 

     Less than 12 Months     12 Months or Greater      Total  
     Fair Value      Gross
Unrealized
Losses
    Fair Value      Gross
Unrealized
Losses
     Fair Value      Gross
Unrealized
Losses
 

U.S. Treasury securities

   $ 2,522      $ (1   $ —        $ —        $ 2,522      $ (1

Corporate bonds

     9,919        (6     —          —          9,919        (6

Commercial paper

     5,227        (2     —          —          5,227        (2
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 17,668      $ (9   $ —        $ —        $ 17,668      $ (9
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

As of September 30, 2017 and December 31, 2016, the Company held a total of 17 out of 28 positions and 18 out of 34 positions, respectively, that were in an unrealized loss position, none of which had been in an unrealized loss position for 12 months or greater. Based on the Company’s review of these securities, the Company believes that the cost basis of its available-for-sale marketable securities is recoverable and that, therefore, it had no other-than-temporary impairments on these securities as of September 30, 2017 and December 31, 2016. The Company does not intend to sell these debt securities and the Company believes it is not more likely than not that it will be required to sell these securities before the recovery of their amortized cost basis, which may be maturity.

4. Accumulated Other Comprehensive Income (Loss)

The following table summarizes the changes in accumulated other comprehensive income (loss), or AOCI, net of tax, from unrealized gains (losses) on available-for-sale marketable securities, the Company’s only component of AOCI, for the nine months ended September 30, 2017 and September 30, 2016.

 

     Total Accumulated
Other
Comprehensive
Income (Loss)
 

Balance, December 31, 2016

   $ 3  
  

 

 

 

Other comprehensive income before reclassifications

     41  

Amount reclassified from accumulated other comprehensive income

     (4
  

 

 

 

Net current period other comprehensive income

     37  
  

 

 

 

Balance, September 30, 2017

   $ 40  
  

 

 

 
  
  

Balance, December 31, 2015

   $ (35
  

 

 

 

Other comprehensive income before reclassifications

     67  

Amount reclassified from accumulated other comprehensive income

     (12
  

 

 

 

Net current period other comprehensive income

     55  
  

 

 

 

Balance, September 30, 2016

   $ 20  
  

 

 

 

 

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Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

The reclassifications out of AOCI and into net loss were as follows:

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
    Affected Line Item in the

Component of AOCI

   2017      2016      2017      2016     Statements of Operations

Unrealized gains on available-for-sale marketable securities

   $ —        $ 12      $ 4      $ 12     Other income
     —          —          —          —       Benefit from income taxes
  

 

 

    

 

 

    

 

 

    

 

 

   
   $ —        $ 12      $ 4      $ 12    
  

 

 

    

 

 

    

 

 

    

 

 

   

The amount reclassified out of AOCI into net loss was determined by specific identification.

5. Fair Value Measurements

As of September 30, 2017 and December 31, 2016, the Company’s financial instruments consisted of cash and cash equivalents, available-for-sale marketable securities, restricted cash, accounts payable and accrued liabilities. The fair values of cash and cash equivalents, restricted cash, accounts payable and accrued liabilities approximate their carrying values due to the short-term nature of these financial instruments. Available-for-sale marketable securities are reported on the Company’s Condensed Balance Sheets as Marketable securities at their fair values, based upon pricing of securities with the same or similar investment characteristics as provided by third-party pricing services, as described below.

Current accounting guidance defines fair value, establishes a framework for measuring fair value in accordance with ASC section 820, and requires certain disclosures about fair value measurements. The valuation techniques included in the guidance are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.

The Company classifies its investments in a fair value hierarchy that is intended to increase consistency and comparability in fair value measurements and related disclosures. The fair value hierarchy is divided into three levels based on the source of inputs as follows:

 

    Level 1 – Observable inputs – quoted prices in active markets for identical assets and liabilities.

 

    Level 2 – Observable inputs other than the quoted prices in active markets for identical assets and liabilities – such as quoted prices for similar instruments, quoted prices for identical or similar instruments in inactive markets, or other inputs that are observable or can be corroborated by observable market data.

 

    Level 3 – Unobservable inputs – includes amounts derived from valuation models where one or more significant inputs are unobservable and require the Company to develop relevant assumptions.

Valuation Techniques – Level 2 Inputs

The Company estimates the fair values of its financial instruments categorized as level 2 in the fair value hierarchy, including U.S. Treasury securities, U.S. government agency obligations, corporate bonds, commercial paper and money market funds with similar underlying investments, by taking into consideration valuations obtained from third-party pricing services. The pricing services use industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, benchmark yields, issuer credit spreads, benchmark securities, and other observable inputs. The Company obtains a single price for each financial instrument and does not adjust the prices obtained from the pricing service.

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

The Company validates the prices provided by its third-party pricing services by reviewing their pricing methods, obtaining market values from other pricing sources and comparing them to the share prices presented by the third-party pricing services. After completing its validation procedures, the Company did not adjust or override any fair value measurements provided by its third-party pricing services as of September 30, 2017 or December 31, 2016.

The following tables summarize the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2017 and December 31, 2016.

Fair value measurement as of September 30, 2017

 

                                                                                                                                   
Financial assets           Quoted prices in      Significant other      Significant  
            active markets for      observable      unobservable  
            identical assets      inputs      inputs  

Type of Instrument

   Total      (Level 1)      (Level 2)      (Level 3)  

Cash and cash equivalents:

           

Money market fund and checking accounts

   $ 11,792      $ 11,792      $ —        $ —    

Available-for-sale marketable securities:

           

Money market fund

     42,875        —          42,875        —    

U.S. government agency obligations

     7,800        —          7,800        —    

Corporate bonds

     19,363        —          19,363        —    

Commercial paper

     21,152        —          21,152        —    

Restricted cash:

           

Commercial money market account

     1,469        1,469        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

   $ 104,451      $ 13,261      $ 91,190      $ —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Fair value measurement as of December 31, 2016:

 

                                                                                                                                   
Financial assets           Quoted prices in      Significant other      Significant  
            active markets for      observable      unobservable  
            identical assets      inputs      inputs  

Type of Instrument

   Total      (Level 1)      (Level 2)      (Level 3)  

Cash and cash equivalents:

           

Money market fund and checking accounts

   $ 12,092      $ 12,092      $ —        $ —    

Available-for-sale marketable securities:

           

Money market fund

     8,276        —          8,276        —    

U.S. Treasury securities

     2,522        —          2,522        —    

U.S. government agency obligations

     3,502        —          3,502        —    

Corporate bonds

     16,677        —          16,677        —    

Commercial paper

     15,207        —          15,207        —    

Restricted cash:

           

Commercial money market account

     1,469        1,469        —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

   $ 59,745      $ 13,561      $ 46,184      $ —    
  

 

 

    

 

 

    

 

 

    

 

 

 

There were no purchases, sales or maturities of Level 3 financial assets and no unrealized gains or losses related to Level 3 available-for-sale marketable securities during the nine months ended September 30, 2017 or 2016. There were no transfers of financial assets between Levels 1, 2, or 3 classifications during the nine months ended September 30, 2017 or 2016.

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

6. Restricted Cash

The Company is required to maintain stand-by letters of credit as security deposits under each of its leases, one for its former operating facility in Shelton, Connecticut and the other for its office space in Stamford, Connecticut (refer to Note 14, Commitments and Contingencies ). The fair value of each letter of credit approximates its contract value. In each case, the Company’s bank requires the Company to maintain restricted cash balances to serve as collateral for the letter of credit issued to the respective landlords by the bank. As of September 30, 2017, the restricted cash balances for the Shelton lease and the Stamford lease were both invested in a commercial money market account.

The restricted cash balance for the Shelton lease remains at $700 through the end of the lease term. For the Stamford lease, the letter of credit balance remains at $769 through May 2019 and may, upon request from the Company, thereafter be reduced to $408 through the end of the lease term in November 2023. The reduction in the balance of the letter of credit for the Stamford lease is contingent upon the Company not being in default of any provisions of that lease prior to request for the reduction. As of September 30, 2017 and December 31, 2016, the Company had $700 of restricted cash related to the Shelton lease in current assets and $769 of restricted cash related to the Stamford lease in long-term assets.

7. Prepaid expenses

As of September 30, 2017, prepaid expenses were $1,492, consisting of $984 of prepaid R&D clinical costs, $346 of prepaid insurance and $162 of other prepaid costs. As of December 31, 2016, prepaid expenses were $1,530 consisting of $1,256 of prepaid R&D clinical costs, $112 of prepaid insurance and $162 of other prepaid costs.

8. Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consist of the following:

 

     September 30, 2017      December 31, 2016  

Accounts payable

   $ 1,187      $ 4,738  

Accrued research projects

     3,758        4,352  

Accrued professional fees

     473        163  

Accrued compensation and benefits

     1,496        1,514  

Accrued other

     358        766  
  

 

 

    

 

 

 

Total

   $ 7,272      $ 11,533  
  

 

 

    

 

 

 

9. Stockholders’ Equity

On March 30, 2017, the Company entered into an underwriting agreement with Piper Jaffray & Co. and Stifel, Nicolaus & Company, Incorporated, as representatives of the several underwriters named therein, relating to the issuance and sale by the Company of up to 5,117,500 shares of its common stock, including 667,500 shares of common stock the underwriters had the option to purchase, at a public offering price of $18.00 per share, or the Offering. The Offering was made pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-216657), filed with the SEC on March 13, 2017 and declared effective on March 24, 2017, and a related prospectus supplement dated March 30, 2017, which was filed with the SEC on March 31, 2017.

On April 5, 2017, the Company closed the Offering, including the full exercise of the underwriters’ option to purchase 667,500 additional shares of common stock. The Company received net proceeds of approximately $86,224, after deducting the underwriting discounts and commissions and offering expenses paid by the Company of $294.

 

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Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

10. Collaborations

Maruishi Pharmaceutical Co., Ltd.

In April 2013, the Company entered into the Maruishi Agreement under which the Company granted Maruishi an exclusive license to develop, manufacture, and commercialize drug products containing CR845 for acute pain and uremic pruritus in Japan. Maruishi has the right to grant sub-licenses in Japan, which entitles the Company to receive sub-license fees, net of prior payments made by Maruishi to the Company. Under the Maruishi Agreement, the Company and Maruishi are required to use commercially reasonable efforts, at their own expense, to develop, obtain regulatory approval for and commercialize CR845 in the United States and Japan, respectively. In addition, the Company provided Maruishi specific clinical development services for CR845 in Maruishi’s field of use.

At inception of the Maruishi Agreement, the Company identified two deliverables under ASC 605-25: (1) the license; and (2) the R&D services specific to the uremic pruritus field of use, both of which were determined to have standalone value and have been accounted for as separate units of accounting from the outset of the arrangement.

In March 2017, Maruishi entered into a sub-license agreement with Kissei Pharmaceutical Co. Ltd. for the development and sales/marketing of CR845 (called MR13A9 by Maruishi) for the treatment of uremic pruritus in dialysis patients in Japan. Consequently, during the nine months ended September 30, 2017, the Company recognized revenue of $843 related to the sub-license fee. The Company allocated the amount of the sub-license fee to each of the two identified deliverables in the same proportion as the upfront license fee that the Company received at inception of the Maruishi Agreement. Accordingly, $530 was recognized as license and milestone fees revenue and $313 was recognized as collaborative revenue.

The Company recognized $68 and $86 of clinical compound revenue during the nine months ended September 30, 2017 and 2016, respectively, from the sale of clinical compound to Maruishi but did not recognize any clinical compound revenue during the three months ended September 30, 2017 or 2016.

The Company incurred $61 and $78 of R&D expense during the nine months ended September 30, 2017 and 2016, respectively, consisting of cost of clinical compound but did not recognize any R&D expense related to the Maruishi Agreement during the three months ended September 30, 2017 and 2016.

11. Net Loss Per Share

The Company computes basic net income (loss) per share by dividing net income (loss) by the weighted-average number of shares of common stock outstanding. Diluted net income per share includes the potential dilutive effect of common stock equivalents as if such securities were exercised during the period, when the effect is dilutive. Common stock equivalents may include outstanding stock options, which are included using the treasury stock method when dilutive. For the three and nine months ended September 30, 2017 and 2016, the Company excluded the effects of potentially dilutive shares that were outstanding during those respective periods from the denominator as their inclusion would be anti-dilutive due to the Company’s net losses during those periods. The denominators for the three and nine months ended September 30, 2017 reflect the issuance of 5,117,500 common shares in the Offering on April 5, 2017, on a weighted-average basis (see Note 9, Stockholders’ Equity , above).

 

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Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

The denominators used in the net loss per share computations are as follows:

 

                                                                           
     Three Months Ended September 30,      Nine Months Ended September 30,  
             2017                      2016                      2017                      2016          

Basic:

           

Weighted average common shares outstanding

     32,591,550        27,282,863        30,729,752        27,275,133  
  

 

 

    

 

 

    

 

 

    

 

 

 

Diluted:

           

Weighted average common shares outstanding -Basic

     32,591,550        27,282,863        30,729,752        27,275,133  

Common stock options*

     —          —          —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Denominator for diluted net loss per share

     32,591,550        27,282,863        30,729,752        27,275,133  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

* No amounts were considered as their effects would be anti-dilutive.

Basic and diluted net loss per share are computed as follows:

 

    Three Months Ended September 30,     Nine Months Ended September 30,  
              2017                         2016                         2017                         2016            

Net loss

  $ (12,444   $ (11,542   $ (43,948   $ (35,308
 

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares outstanding:

       

Basic and Diluted

    32,591,550       27,282,863       30,729,752       27,275,133  
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, Basic and Diluted

  $ (0.38   $ (0.42   $ (1.43   $ (1.29
 

 

 

   

 

 

   

 

 

   

 

 

 

As of September 30, 2017 and 2016, 3,492,786 and 2,299,117 stock options, respectively, were outstanding, which could potentially dilute basic earnings per share in the future, but were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive.

12. Stock-Based Compensation

2014 Equity Incentive Plan

The Company’s 2014 Equity Incentive Plan, or the 2014 Plan, is administered by the Company’s Board of Directors or a duly authorized committee thereof, referred to as the Plan administrator. The 2014 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock unit awards, stock appreciation rights,

 

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Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

performance stock awards and other forms of equity compensation, collectively referred to as Stock Awards. Additionally, the 2014 Plan provides for the grant of performance cash awards. Incentive stock options may be granted only to employees. All other awards may be granted to employees, including officers, non-employee directors, and consultants. No incentive stock options may be granted under the 2014 Plan after the tenth anniversary of the effective date of the 2014 Plan. Stock Awards granted under the 2014 Plan vest at the rate specified by the Plan administrator. Initial grants of Stock Awards made to employees and non-employee consultants generally vest as to 25% on the first anniversary of the date of grant and the balance ratably over the next 36 months. However, as of January 1, 2016, subsequent grants of Stock Awards made to employees and non-employee consultants vest monthly over a period of four years from the grant date. Stock options initially granted to members of the Company’s Board of Directors vest on the date of the Annual Meeting of Stockholders at which their initial term expires based on the class of Director. Subsequent grants to Directors that are made automatically at Annual Meetings of Stockholders vest fully on the first anniversary of the date of grant. The Plan administrator determines the term of Stock Awards granted under the 2014 Plan up to a maximum of ten years.

The aggregate number of shares of the Company’s common stock reserved for issuance under the 2014 Plan has automatically increased on January 1 of each year, beginning on January 1, 2015 and will continue to increase on January 1 of each year through and including January 1, 2024, by 3% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s Board of Directors. On January 1, 2017, the aggregate number of shares of common stock that may be issued pursuant to Stock Awards under the 2014 Plan automatically increased from 3,101,707 to 3,920,613. The maximum number of shares that may be issued pursuant to the exercise of incentive stock options under the 2014 Plan is 30,000,000 shares.

Under the 2014 Plan, the Company granted 415,000 and 1,253,500 stock options during the three and nine months ended September 30, 2017, respectively, and 75,000 and 797,000 stock options during the three and nine months ended September 30, 2016, respectively. The fair values of stock options granted during the three and nine months ended September 30, 2017 and 2016 were estimated as of the dates of grant using the Black-Scholes option pricing model with the following assumptions:

 

     Three Months Ended September 30,    Nine Months Ended September 30,
             2017                    2016            2017    2016

Risk-free interest rate

   1.87% - 1.97%    1.19%    1.85% - 2.57%    1.19% - 1.79%

Expected volatility

   81.4% - 81.7%    71.9%    75.3% - 83.3%    67.8% - 72.6%

Expected dividend yield

   0%    0%    0%    0%

Expected life of employee options (in years)

   6.25    6.25    6.25    6.25

Expected life of nonemployee options (in years)

   —      —      10    10

The weighted-average grant date fair value of options granted to employees, non-employee members of the Company’s Board of Directors for their Board service and non-employee consultants during the three and nine months ended September 30, 2017 was $10.00 and $11.61, respectively, and during the three and nine months ended September 30, 2016 was $3.92 and $3.81, respectively.

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

As of September 30, 2017 and 2016, the Company used the Black-Scholes option valuation model with the following assumptions to re-measure the fair value of all outstanding options that had been granted to non-employee consultants during the vesting period of each tranche in accordance with ASC 505-50:

 

                                                                           
     As of September 30,
     2017    2016

Risk-free interest rate

   1.28% -2.28%    1.35% - 1.56%

Expected volatility

   75.2% - 84.0%    73.9% - 74.6%

Expected dividend yield

   0%    0%

Expected life of non-employee options (in years)

   0.88 - 9.44    7.33 - 9.60

The weighted-average fair value of outstanding options that had been granted to nonemployee consultants, as re-measured during the vesting period of each tranche in accordance with ASC 505-50, was $8.31 and $5.75 as of September 30, 2017 and 2016, respectively.

On January 1, 2017, the Company adopted ASU 2016-09, Improvements to Employee Share-Based Payment Accounting (see Note 2, Basis of Presentation Recently Adopted Accounting Pronouncements ). On the date of adoption of ASU 2016-09, the Company began to account for forfeitures of unvested stock options as they occur rather than estimate forfeiture rates that were applied to unvested stock option awards, as under the previous accounting guidance. Accordingly, on the date of adoption, the Company recorded a cumulative-effect adjustment to stockholders’ equity of $45 for all stock option awards that were unvested as of that date.

During the three and nine months ended September 30, 2017 and 2016, the Company recognized compensation expense relating to stock options, as follows:

 

     Three Months Ended September 30,      Nine Months Ended September 30,  
             2017                      2016                      2017                      2016          

Research and development

   $ 619      $ 375      $ 1,784      $ 867  

General and administrative

     1,475        402        2,736        1,104  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total stock option expense

   $ 2,094      $ 777      $ 4,520      $ 1,971  
  

 

 

    

 

 

    

 

 

    

 

 

 

In connection with the retirement of the Company’s former Chief Financial Officer, effective August 15, 2017, or the Modification Date, the Company modified the terms of the former Chief Financial Officer’s outstanding Stock Awards to: (1) accelerate 50% of the 98,771 unvested shares underlying his outstanding Stock Awards immediately as of the Modification Date, and specify that the remainder will vest monthly through the date of termination of his continuous service to the Company and (2) extend the period during which his outstanding Stock Awards for an aggregate of 183,000 shares may be exercised through the six-month anniversary of the date of termination of his continuous service to the Company. As of the Modification Date, Company entered into a consulting agreement with the former Chief Financial Officer under which he will provide continuous service to the Company by assisting with the transition of his role to the Company’s Chief Financial Officer. Pursuant to the terms of the 2014 Plan and his outstanding Stock Awards, such Stock Awards will continue to vest under their original vesting conditions as long as he provides continuous service to the Company (including as a consultant). The initial term of his consulting agreement will end on February 15, 2018, with month-to-month renewals thereafter at the Company’s option.

The Company determined that the acceleration of vesting for Stock Awards that would have vested based on their original vesting terms through the term of the consulting services was a Type 1 modification pursuant to ASC 718, Compensation-Stock Compensation because those Stock Awards would have vested whether or not the vesting of those Stock Awards had been accelerated. However, acceleration of vesting for the remaining Stock Awards was a Type 3 modification pursuant to ASC 718 because absent the modification terms, those Stock Awards would have been forfeited as of the last day that the former Chief Financial Officer provides continuous service as a consultant.

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

On the Modification Date, the Company recognized $474 of compensation expense, which is included in General and administrative expense in the table above, for the three and nine months ended September 30, 2017, with respect to these modifications. In addition, the Company expects to recognize compensation expense totaling $92 on a straight-line basis during the term of his continuous service to the Company and will mark to market the fair value of those Stock Awards in accordance with ASC 505-50 and will recognize compensation expense accordingly during that period.

A summary of stock option award activity related to employees, non-employee members of the Company’s Board of Directors and non-employee consultants as of and for the nine months ended September 30, 2017 is presented below:

 

                                                       
     Number of
Shares
     Weighted
Average
Exercise
Price
 

Outstanding, December 31, 2016

     2,548,408      $ 8.75  

Granted

     1,253,500        16.40  

Exercised

     (194,122      7.81  

Forfeited

     (115,000      7.74  
  

 

 

    

Outstanding, September 30, 2017

     3,492,786        11.58  
  

 

 

    

Options exercisable, September 30, 2017

     1,366,118      $ 9.86  
  

 

 

    

The Company does not expect to realize any tax benefits from its stock option activity or the recognition of stock-based compensation expense because the Company currently has net operating losses and has a full valuation allowance against its deferred tax assets. Accordingly, no amounts related to excess tax benefits have been reported in cash flows from operations for the nine months ended September 30, 2017 and 2016.

13. Income Taxes

For the three months ended September 30, 2017 and 2016, pre-tax losses were $12,589 and $11,597, respectively, and for the nine months ended September 30, 2017 and 2016, pre-tax losses were $44,126 and $35,587, respectively. The Company recognized a full tax valuation allowance against its deferred tax assets as of September 30, 2017 and December 31, 2016. Upon adoption of ASU 2016-09 on January 1, 2017, the tax benefit related to the exercise of stock options is recognized as a deferred tax asset that is offset by a corresponding valuation allowance.

The benefit from income taxes of $145 and $55 for the three months ended September 30, 2017 and 2016, respectively, and $178 and $279 for the nine months ended September 30, 2017 and 2016, respectively, relates to state R&D tax credits exchanged for cash pursuant to the Connecticut R&D Tax Credit Exchange Program, which permits qualified small businesses engaged in R&D activities within Connecticut to exchange their unused R&D tax credits for a cash amount equal to 65% of the value of the exchanged credits.

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

14. Commitments and Contingencies

Contractual obligations and commitments as of September 30, 2017, consisting of future minimum lease payments under the Company’s Stamford and Shelton leases, were as follows:

 

                                                                                                                                                         
     Payment Due for the Year Ending December 31,                
     2017      2018      2019      2020      2021      Thereafter      Total  

Stamford operating lease

   $ 294      $ 1,093      $ 1,217      $ 1,241      $ 1,266      $ 2,348      $ 7,459  

Shelton operating lease

     129        —          —          —          —          —          129  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 
   $ 423      $ 1,093      $ 1,217      $ 1,241      $ 1,266      $ 2,348      $ 7,588  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Stamford Operating Lease

In December 2015, the Company entered into a lease agreement, or the Stamford Lease, with Four Stamford Plaza Owner LLC, or the Landlord, for office space in Stamford, Connecticut, or the Premises, for the purpose of relocating its headquarters. The initial term of the Stamford Lease commenced in May 2016, or the Commencement Date, and ends in November 2023. The Stamford Lease requires monthly lease payments, including rent escalations and rent holidays, during the initial lease term. The Company began to make rental payments from the Commencement Date. The Company records monthly rent expense on a straight-line basis from March 2016, upon taking possession of the Premises, through October 2023. As of September 30, 2017 and December 31, 2016, the balance of deferred lease obligation, representing the difference between cash rent paid and straight-line rent expense, was $823 and $583, respectively. The Stamford Lease is renewable for one five-year term.

As of the Commencement Date, the Stamford landlord had made tenant improvements of approximately $1,094 to the leased premises. Such amount was included in Property and equipment, net and in Deferred lease obligation on the Company’s Balance Sheet on that date. The portion of Deferred lease obligation that is related to tenant improvements is being amortized as a reduction to rent expense over the same term as rent expense. As of September 30, 2017 and December 31, 2016, the balance of Deferred lease obligation related to tenant improvements was $878 and $987, respectively.

In connection with the signing of the Stamford Lease, the Company entered into a standby letter of credit agreement, which serves as a security deposit for the Premises. The standby letter of credit is automatically renewed annually through November 2023. This standby letter of credit is secured with restricted cash in a money market account (refer to Note 6, Restricted Cash ).

Shelton Operating Lease

In May 2016, the Company relocated its headquarters to Stamford, Connecticut and vacated its former operating facility in Shelton, Connecticut, although the Company continues to lease its former Shelton operating facility under an operating lease, or the Shelton Lease, which commenced in 2007 and has a termination date of October 13, 2017, with month-to-month rental payments due thereafter, if necessary (see below).

The Shelton Lease, requires monthly lease payments through its term. The Company recorded monthly rent expense associated with the Shelton Lease on a straight-line basis from inception of the Shelton Lease through May 2016. In accordance with the accounting guidance in ASC 420-10-25-13 regarding exit or disposal cost obligations, as of May 2016, the Company recorded rent expense, within R&D expense and General and administrative expense, and accrued a liability of $1,312, which represents the fair value of costs that will continue to be incurred during the remaining term of the Shelton Lease without economic benefit to the Company. As of September 30, 2017, the carrying amount of the liability of $129, which includes the minimum rental payments in the table above, including additional rent for the period from October 14, 2017 to November 13, 2017, while the leased space is being restored to be returned to the landlord, was included in Accounts payable and accrued expenses on the Company’s Balance Sheet.

 

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CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

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

(unaudited)

 

A reconciliation of the balances of the accrued Shelton Lease cease-use liability for the three and nine months ended September 30, 2017 and 2016 is as follows:

 

Three Months Ended September 30,

 

2017

        

2016

 

Balance July 1, 2017

   $ 276        Balance, July 1, 2016    $ 1,232  

Charges

     90       

Charges

     —    

Rental payments

     (247     

Rental payments

     (234

Interest accretion

     10       

Interest accretion

     —    
  

 

 

         

 

 

 

Balance September 30, 2017

   $ 129        Balance September 30, 2016    $ 998  
  

 

 

         

 

 

 

Nine Months Ended September 30,

 

2017

        

2016

 

Balance, January 1, 2017

   $ 756        Balance January 1, 2016    $ —    

Charges

     90       

Charges

     1,312  

Rental payments

     (741     

Rental payments

     (314

Interest accretion

     24       

Interest accretion

     —    
  

 

 

         

 

 

 

Balance September 30, 2017

   $ 129        Balance September 30, 2016    $ 998  
  

 

 

         

 

 

 

In conjunction with the signing of the Shelton Lease, the Company entered into a standby letter of credit agreement, which expires 60 days after lease termination, as a security deposit for the premises. As of September 30, 2017 and December 31, 2016, the balance of the letter of credit was $700, which is secured with restricted cash (refer to Note 6, Restricted Cash ).

The Company accelerated the amortization of the Shelton leasehold improvements from the date of signing of the Stamford Lease in December 2015 through the date that the Company vacated the Shelton facility in May 2016. Additional amortization expense as a result of such acceleration amounted to $899 (additional net loss per share of $0.03) for the nine months ended September 30, 2016.

 

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Item 2. Management s Discussion and Analysis of Financial Condition and Results of Operations .

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” and or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.

The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:

 

    the success and timing of, and the reporting of results from, our clinical trials, including our clinical trial programs for I.V. CR845 in acute pain and uremic pruritus and Oral CR845 in chronic pain and uremic pruritus;

 

    the timing of initiation of our Phase 3 pivotal program for I.V. CR845 in uremic pruritus;

 

    our plans to develop and commercialize I.V. CR845, Oral CR845 and our other product candidates;

 

    the potential results of ongoing and planned clinical trials and future regulatory and development milestones for our product candidates;

 

    our ability to obtain and maintain regulatory approval of our product candidates, including I.V. and Oral CR845, and the labeling under any approval we may obtain;

 

    the anticipated commercial launch of our lead product candidate, I.V. CR845;

 

    the potential of future scheduling of I.V. CR845 by the United States Drug Enforcement Administration, or DEA, if regulatory approval is received;

 

    the performance of our current and future collaborators, including Maruishi Pharmaceuticals Co. Ltd., or Maruishi, and Chong Kun Dang Pharmaceutical Corp., or CKDP, and our ability to maintain such collaborations;

 

    our ability to establish additional collaborations for our product candidates;

 

    the continued service of our key scientific or management personnel;

 

    our ability to establish commercialization and marketing capabilities;

 

    the rate and degree of market acceptance of any approved products;

 

    our ability to obtain and maintain coverage and adequate reimbursement from third-party payers for any approved products;

 

    our planned use of our cash and cash equivalents and marketable securities and the clinical milestones we expect to fund with such proceeds;

 

    the accuracy of our estimates regarding expenses, future revenues and capital requirements;

 

    our ability to obtain funding for our operations;

 

    our ability to obtain and maintain intellectual property protection for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others; and

 

    the performance of third-party manufacturers and clinical research organizations.

 

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You should refer to Part I Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2016 for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with: (1) the Condensed Financial Statements and related notes thereto which are included in this Quarterly Report on Form 10-Q; and (2) our Annual Report on Form 10-K for the year ended December 31, 2016.

Introduction

We are a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. We are developing a novel and proprietary class of product candidates, led by CR845, that target the body’s peripheral nervous system and certain immune cells. CR845 was shown to reduce pain intensity in clinical trials of patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics. CR845 has also been shown to alleviate moderate-to-severe pruritus associated with chronic kidney disease, or CKD-aP, in hemodialysis, or HD, patients.

We commenced operations in 2004, and our primary activities to date have been organizing and staffing our company, developing our product candidates, including conducting preclinical studies and clinical trials of CR845-based product candidates, and raising capital. To date, we have financed our operations primarily through sales of our equity and debt securities and payments from license agreements. We have no products currently available for sale, and substantially all of our revenue to date has been revenue from license agreements, although we have received nominal amounts of revenue under research grants.

Product Development Pipeline

The current status of the development of our product candidates is as follows:

 

Product
Candidate

  

Primary

Indication(s)

  

Status

  

Commercialization Rights

I.V. CR845

   Acute Postoperative Pain   

Phase 3 Adaptive Clinical Trial Program.

 

•    Interim conditional power analysis completed. Phase 3 trial continuing.

 

•    Completion of enrollment of up to 450 patients expected by year end 2017 or early 2018.

  

Cara (Worldwide, other than Japan and South Korea)

 

Maruishi (Japan)

 

CKDP (South Korea)

Oral CR845

   Chronic Pain    Phase 2b osteoarthritis, or OA, clinical trial completed. Top-line results in patients with OA of the knee or hip released.   

Cara (Worldwide, other than South Korea)

 

CKDP (South Korea)

 

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Product
Candidate

  

Primary

Indication(s)

  

Status

  

Commercialization Rights

I.V. CR845    Pruritus CKD-HD   

•    Phase 2/3 two-part Adaptive Clinical Trial Program in hemodialysis patients with CKD-aP. Top-line data from Phase 2 trial released. End of Phase 2 meeting with FDA completed.

 

•    Phase 3 long-term safety study ongoing; initiation of first pivotal Phase 3 efficacy trial expected by the end of 2017.

 

•    Breakthrough therapy designation granted by FDA in June 2017.

  

 

Cara (Worldwide, other than Japan and South Korea)

 

Maruishi (Japan)

 

CKDP (South Korea)

Oral CR845

   Pruritus CKD (Stage III -V)   

•    Phase 1 safety and PK study in patients with CKD undergoing hemodialysis to define tablet strengths to enable development of an oral tablet formulation for moderate-to-severe CKD-aP complete.

 

•    Phase 1 trial in patients with Stage III to V CKD (non-hemodialysis) initiated in October 2017.

  

Cara (Worldwide, other than Japan and South Korea)

 

Maruishi (Japan)

 

CKDP (South Korea)

Oral CR845

   Pruritus CLD   

•    Submission of IND Application for symptomatic relief of chronic liver disease-associated pruritus expected in the fourth quarter of 2017.

  

Cara (Worldwide, other than South Korea)

 

CKDP (South Korea)

CR701

   Chronic Pain    Preclinical    Cara (Worldwide)

I.V. CR845 for Treatment of Acute Postoperative Pain

Our product candidate, CR845, is a new chemical entity that is designed to produce pain relief by specifically stimulating kappa opioid receptors outside of the central nervous system. Intravenous, or I.V., CR845, has demonstrated significant pain relief and a favorable safety and tolerability profile in three Phase 2 clinical trials in patients with acute postoperative pain. In addition, in the fourth quarter of 2014, we successfully completed a Human Abuse Liability, or HAL, trial of I.V. CR845 in which I.V. CR845 met the trial’s primary endpoint by demonstrating highly statistically significant lower “drug liking” scores as measured by visual analog scale (VAS) Emax (p<0.0001) when compared to the approved Schedule IV opioid, pentazocine. We believe that the totality of the results from the HAL trial are supportive of the potential for CR845 to be the first non-scheduled or low (Schedule V) scheduled peripheral opioid for acute pain.

In September 2015, we initiated our Phase 3 clinical trial program for I.V. CR845 in postoperative pain with the dosing of subjects in an adaptive pivotal trial in patients undergoing a range of abdominal surgeries. This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design trial with repeated doses of I.V. CR845 or placebo administered both prior to and following abdominal surgery in male and female patients. The trial protocol initially included three dose levels of I.V. CR845 (1.0 ug/kg, 2.0 ug/kg and 5.0 ug/kg), which were compared to placebo with an interim conditional power assessment built in to identify optimal doses to be used to complete the trial.

In June 2016, we modified the trial protocol and resumed the trial as a three-arm trial, testing two doses of I.V. CR845 (1.0 ug/kg and 0.5 ug/kg) versus placebo, based on a safety review by us, the trial’s Independent Data Monitoring

 

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Committee, or IDMC, and the U.S. Food and Drug Administration, or FDA, of unblinded safety data from the first 90

patients dosed. The safety review was conducted in response to a clinical hold that the FDA placed on the trial in February 2016 and removed in April 2016 following the safety review. The clinical hold was based on a pre-specified stopping rule related to elevated serum sodium levels of greater than 150 mmol/L that was included in the clinical trial protocol.

The revised trial is enrolling up to 450 patients within the United States undergoing a range of abdominal surgeries, all of which are associated with moderate-to-severe postoperative pain. The primary efficacy endpoint is the Change in Pain Intensity over the 24-hour postoperative period using a common measurement method known as area under the curve, or AUC, using the patient-reported Numeric Rating Scale, or NRS, score collected at pre-specified time points through 24 hours post-surgery. Postoperative nausea and vomiting is also being evaluated as a secondary efficacy endpoint.

In June 2017, we announced the completion of a prespecified interim conditional power analysis of our adaptive Phase 3 trial of I.V. CR845. Based on the guidance of the IDMC, the trial will continue in accordance with its current protocol, testing two doses of I.V. CR845 (1.0 ug/kg and 0.5 μg/kg I.V.) versus placebo in up to 450 patients undergoing abdominal surgery. The IDMC also reviewed the available safety information, including serum sodium levels, and confirmed that both doses of I.V. CR845 were observed to be well tolerated with no significant changes in the monitored safety parameters. We expect completion of enrollment for this trial by year end 2017 or early 2018.

In addition, in April 2017, we announced summary results from our quantitative Phase 1 trial evaluating respiratory safety of I.V. CR845. Respiratory depression remains the most life-threatening side effect of traditional, centrally acting, opioid analgesics, the most commonly used drug class for current treatment of postoperative pain in the United States. The Phase 1 trial was a randomized, double-blind, placebo-controlled, three-way crossover trial of two doses of I.V. CR845 versus placebo on three measures of respiratory drive in 15 healthy volunteers. Each subject was randomized to one of three treatment sequences and was administered I.V. bolus placebo, I.V. CR845 (1.0 ug/kg) and I.V. CR845 (5.0 ug/kg) on sequential 24-hour periods, with I.V. CR845 (5.0 ug/kg) representing a projected five-fold supra-therapeutic dose. After each administration, and continuing through four hours post-dosing, end-tidal CO2, or ETCO2, oxygen saturation, or SpO2, and respiratory rate were continuously monitored. The primary safety endpoints were: a >10 mmHg sustained (>30 seconds duration) increase in ETCO2 above baseline or to >50 mmHg, and a sustained reduction in SpO2 to <92 percent.

There were no statistically significant differences in any respiratory measures observed between groups throughout the four-hour observation period post-dosing and no individual subject met the threshold for a respiratory safety event. Additionally, all treatment-emergent adverse events were previously reported with CR845 administration and were mild, resolving without intervention. Full data from this study were also presented at the American Society of Anesthesiologists’ annual meeting in Boston in October, 2017.

Oral CR845 for Treatment of Osteoarthritis

We are also developing an oral version of CR845, or Oral CR845, for acute and chronic pain. In August 2015, we advanced the tablet formulation of Oral CR845 into a Phase 2a clinical trial in patients with osteoarthritis, or OA, of the knee or hip. The Phase 2a trial was a single-blind, randomized, multiple ascending dose trial designed to evaluate the safety, pharmacokinetics, or PK, and effectiveness of four tablet strengths (0.25 mg, 0.5 mg, 1.0 mg and 5.0 mg) of Oral CR845 tablets dosed over a two-week treatment period in 80 patients with OA of the knee or hip in the United States experiencing moderate-to-severe pain, defined as >4 on an 11-point NRS at baseline. Patients discontinued current pain medications five days prior to baseline measurements. In December 2015, we announced positive top-line results from this Phase 2a trial. The results showed a dose-related reduction in mean joint pain score after two weeks of treatment (from baseline) ranging from 25% reduction at the lowest dose (0.25 mg) to up to 34% reduction for the highest (5.0 mg) dose. Additionally, a post-hoc analysis also showed that the reduction in pain score in the 5.0 mg dose group was accompanied by a statistically significant reduction in mean rescue medication of approximately 80% (ANOVA: p= 0.02, for 5.0 mg vs lower dose groups). In this trial, all four tablet strengths were observed to be safe and well tolerated.

The results of the Phase 2a trial established therapeutic doses and a dosing regimen for a larger randomized, double-blind, placebo-controlled Phase 2b trial, which was initiated during the third quarter of 2016. The Phase 2b trial was designed to evaluate three tablet strengths of Oral CR845 (1.0 mg, 2.5 mg and 5.0 mg), dosed twice-daily over an eight-week treatment period in 476 patients with OA of the knee or hip experiencing moderate-to-severe pain across the United States. The primary efficacy endpoint was the change from baseline at week eight, with respect to the weekly mean of the daily pain

 

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intensity score using an NRS score. Secondary endpoints included overall Patient Global Assessment, or PGA, score, and overall improvement in Western Ontario and McMaster Osteoarthritis Index, or WOMAC, scores, two commonly used patient-reported outcome measures, as well as mean reduction in rescue medication.

In June 2017, we announced top-line results from the Phase 2b trial. The results of the primary efficacy analysis of change from baseline in pain intensity NRS score comparing Oral CR845 (all doses) vs. placebo were not statistically significant across all patients (OA of the knee or hip). However, patients with OA of the hip maintained on the 5.0 mg dose to the end of the eight-week treatment period exhibited a statistically significant 39% reduction in mean joint pain score versus placebo (p=0.043); all patients (OA of the knee or hip) maintained on the 5.0 mg dose to the end of the eight-week treatment period exhibited a 35% reduction in mean joint pain score versus placebo, which did not reach statistical significance (p=0.111). For patients maintained on the 5.0 mg dose, there was a statistically significant increase in the proportion of patients whose OA was “very much improved” or “much improved” as indicated by PGA score in both the total patient group (p <0.005 vs. placebo) and in patients with primary OA of the hip (p<0.006 vs. placebo). The reduction in pain score in the 5.0 mg dose group in hip patients was accompanied by a reduction in mean rescue medication of 41% at week eight versus placebo. Patients maintained on the 1.0 mg and 2.5 mg tablet strengths did not exhibit significant reductions in mean joint pain scores compared to placebo. All tablet strengths were generally well tolerated with no drug-related serious adverse events. For the 5.0 mg dose, the most common adverse events reported at the >5 percent incidence level were dry mouth (6%) and constipation (12%). There were no clinically significant changes in serum sodium levels observed during the eight-week treatment period for any dose group. Full results from this trial will be presented at the American College of Rheumatology’s Annual Meeting to be held on November 3-8, 2017 during the late-breaking abstract poster session.

I.V. CR845 for Treatment of Chronic Kidney Disease-Associated Pruritus (CKD-aP)

Pruritus, or itch, is associated with certain chronic conditions such as chronic kidney disease, or CKD, as well as with diseases such as atopic dermatitis, eczema, cholestatic liver disease and psoriasis. Based on CR845’s effect on the peripheral nervous system and immune cells as well as CR845’s anti-pruritic potency in preclinical models, we believe CR845 has the potential to treat pruritus across multiple medical conditions.

Uremic pruritus, also known as CKD-associated pruritus, or CKD-aP, is an intractable systemic itch condition with high prevalence in patients with CKD undergoing dialysis for which there are no approved therapeutics in the United States.

In the fourth quarter of 2014, we reported positive top-line dose-ranging PK and safety data from a Phase 1b clinical trial of I.V. CR845 for the treatment of uremic pruritus. In July 2015, we reported positive top-line efficacy results from this trial, in which we observed that I.V. CR845 demonstrated statistically significant reduction in worst itch intensity, the primary endpoint of the trial, as well as statistically significant improvement in quality of life measures, the trial’s secondary endpoint . We also observed I.V. CR845 to have a favorable safety and tolerability profile in the trial.

Based on the results of this trial, during the fourth quarter of 2015 we completed a guidance meeting with the FDA. We incorporated the feedback we received from the FDA in this guidance meeting in the overall design of our Phase 2/3 clinical trial for I.V. CR845 for the treatment of uremic pruritus. In June 2016, we initiated a two-part Phase 2/3 adaptive design trial of I.V. CR845 in dialysis patients suffering from moderate-to-severe uremic pruritus. In March 2017, we announced top-line data from the Phase 2 trial, which was a randomized, double-blind, placebo-controlled trial of three doses of I.V. CR845 (0.5ug/kg, 1.0 ug/kg and 1.5 ug/kg) administered three times per week after dialysis over an eight-week treatment period in 174 patients with moderate-to-severe uremic pruritus.

The primary endpoint of this trial was the change from baseline of the mean worst itching score for week eight measured on a standard NRS for itch. Patients receiving I.V. CR845 experienced a 68% greater reduction from baseline in worst itch scores than those receiving placebo (p<0.0019). The secondary endpoint of this trial focused on quality of life measures associated with pruritus using the Skindex-10 score, a validated self-assessment scale with higher scores indicating worse quality of life. Patients receiving I.V. CR845 experienced a 100% greater reduction from baseline in the average total Skindex-10 score at week eight versus those receiving placebo (p<0.0007). The total average Skindex-10 score reflected statistically significant reductions in each of the three Skindex-10 domains: disease (p<=0.0001), mood/emotional distress (p=0.01) and social functioning (p=0.009).

Overall, I.V. CR845 was observed to be well tolerated over the eight-week treatment period and the unblinded Drug Safety Monitoring Board did not raise any safety concerns during the course of the trial. The most common adverse events were transient paresthesia (i.e., primarily mid-facial tingling or numbness), somnolence and dizziness, as reported in previous clinical studies of I.V. CR845. Full results of this trial will be presented at Kidney Week 2017, the American Society of Nephrology’s Annual Meeting on November 2-4, 2017.

 

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In June 2017, the FDA granted breakthrough therapy designation for I.V. CR845 for the treatment of moderate-to-severe uremic pruritus in patients with CKD undergoing hemodialysis. This regulatory decision was supported primarily by positive top-line results from the Phase 2 clinical trial of I.V. CR845 in patients with uremic pruritus or CKD-aP. Breakthrough therapy designation is granted to expedite the development and review process for new therapies addressing serious or life-threatening conditions, where preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

In September 2017, we held an End-of-Phase 2 Meeting with the FDA. We, in consultation with the FDA, have established the key elements of the Phase 3 program to support an NDA for I.V. CR845 for the treatment of moderate-to-severe CKD-aP in patients undergoing hemodialysis. Based on our discussions with the FDA, by the end of 2017 we expect to initiate the first pivotal randomized, double-blind, placebo-controlled Phase 3 trial of 0.5 ug / kg of I.V. CR845 (versus placebo) to be administered three times per week after dialysis over a 12-week treatment period in patients undergoing hemodialysis with moderate-to-severe CKD-aP.

We are also conducting a 52-week Phase 3 safety study of I.V. CR845 in patients undergoing hemodialysis with CKD-aP. The trial is enrolling up to 240 hemodialysis patients with CKD-aP who completed one of our prior Phase 2/3 trials of I.V. CR845 (CR845-CLIN2101 Part A or CR845-CLIN2005 Part B). This open-label trial is evaluating the long-term safety of I.V. CR845 at the dose of 0.5ug/kg, a dose that met both primary and secondary efficacy endpoints (reduction of itch and improved quality of life, respectively) in patients with moderate-to-severe CKD-aP in our prior Phase 2 trials and is the selected dose for the planned Phase 3 pivotal trial.

Oral CR845 for Treatment of Chronic Kidney Disease-Associated Pruritus

We recently completed a Phase 1 safety and PK study of multiple doses of Oral CR845 in patients with CKD undergoing hemodialysis to define tablet strengths to inform our ability to develop an oral tablet formulation for moderate-to-severe uremic pruritus. In July 2017, we announced summary results from this trial. The Phase 1 results showed that all four tablet strengths of Oral CR845 (0.25, 0.5, 1.0 and 2.5 mg) were generally well-tolerated when administered either daily or after each dialysis three times per week. Top-line pharmacokinetic analysis indicated that plasma levels of CR845 attained after oral administration of doses up to 2.5 mg were comparable to or exceeded those attained with clinically efficacious doses of I.V. CR845 for the treatment of moderate-to-severe CKD-aP, in patients undergoing hemodialysis. The plasma levels of CR845 attained after oral administration of the 1.0 mg tablet strength approximated those attained with the 1.0 ug/kg I.V. CR845 dose, which demonstrated significant clinical benefit in our Phase 2/3 trial in patients undergoing hemodialysis with CKD-aP.

The Phase 1 trial was a three-part, randomized, placebo-controlled study to evaluate the safety and pharmacokinetics of Oral CR845 tablets in 90 CKD patients undergoing hemodialysis. In Part A, ascending repeated oral doses of 0.25, 0.5, 1.0 and 2.5 mg were given to four cohorts of patients (n=47) after each dialysis (i.e., three times) over a one-week treatment period. In Part B, ascending repeated oral doses of 0.25, 0.5 and 1.0 mg were given daily to three cohorts of hemodialysis patients (n=36). In Part C, the final crossover phase of the study, patients were administered a single 1.0 mg oral dose of CR845 or a single 1.0 ug/kg I.V. dose of CR845 (n=7) given after hemodialysis with a one-week washout period between treatments to determine the absolute bioavailability of Oral CR845. Parts A and B randomized up to 12 patients per dose group (nine active and three placebo). Part C was conducted as an open-label phase with seven patients receiving active drug.

Overall, the frequency of treatment emergent adverse events, or TEAEs, in Oral CR845-treated patients was similar to the group administered placebo. All TEAEs were generally mild and comparable to those reported in our Phase 2/3 trial after I.V. CR845 administration in CKD-aP patients undergoing hemodialysis. Absolute oral bioavailability of the 1.0 mg tablet strength was determined to be similar in CKD patients undergoing hemodialysis to that obtained in non-CKD patients.

 

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In October 2017, we initiated a Phase 1 trial of Oral CR845 in patients with Stage III to V CKD (non-hemodialysis). The Phase 1 trial is designed to examine the pharmacokinetics and safety of three tablet strengths of Oral CR845 (0.25 mg, 0.5 mg and 1.0 mg), dosed daily over a one-week treatment period in up to 80 patients with stage III-V CKD (non-hemodialysis). Data from this trial will inform dose selection and design of a planned placebo-controlled Phase 2 trial of Oral CR845 in patients with stage III-V CKD (non-hemodialysis), which the Company plans to initiate in the first quarter of 2018.

Oral CR845 for Treatment of Chronic Liver Disease-Associated Pruritus

CLD-associated pruritus, or CLD-aP, manifests as “cholestasis” symptoms causing severe whole-body itch. It is an intense, intractable, debilitating condition that significantly disrupts patients’ daily activities and sleep, and consequently impairs their quality of life. Although the pathophysiology is not well understood, it is likely multi-factorial, involving immune system dysregulation (including elevated pro-inflammatory activity) and imbalance in the endogenous opioid system. Consequently, the use of selective kappa-opioid receptor agonists has been suggested for the treatment of pruritus in patients with CLD.

We plan to submit an Investigational New Drug Application for Oral CR845 for symptomatic relief of CLD-aP in the fourth quarter of 2017.

Components of Operating Results

Revenue

To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the near future. Substantially all of our revenue recognized to date has been generated by upfront, milestone and sub-license payments under the Maruishi Agreement and the CKDP Agreement for CR845, a portion of which was deferred upon receipt, as well as license agreements for CR665, our first-generation drug program for which development efforts have ceased. To date, we have earned a total of $4.3 million in clinical development or regulatory milestone payments and sub-license fees, net of contractual foreign currency adjustments and South Korean withholding taxes, but have not received any royalties, under these collaborations.

Research and Development (R&D)

Our R&D expenses relate primarily to the development of CR845. R&D expenses consist of expenses incurred in performing R&D activities, including compensation and benefits for full-time R&D employees, facilities expenses, including overhead expenses, clinical trial and related clinical manufacturing expenses, third-party formulation expenses, fees paid to contract research organizations, or CROs, and other consultants, stock-based compensation for R&D employees and non-employee consultants and other outside expenses. Our R&D expenses also included expenses related to preclinical activities, such as drug discovery, target validation and lead optimization for CR845 and our other, earlier stage programs in prior periods and may include such expenses in the future.

R&D costs are expensed as incurred. Non-refundable advance payments for goods or services to be received in the future for use in R&D activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Most of our R&D costs have been external costs, which we track on a program-by program basis. Our internal R&D costs are primarily compensation expenses for our full-time R&D employees. We do not track internal R&D costs on a program-by-program basis.

R&D activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Based on our current development plans, we presently expect that our R&D expenses for 2018 will increase over those for 2017. However, it is difficult to determine with certainty the duration and completion costs of our current or future preclinical programs and clinical trials of our product candidates, or if, when or to what extent we will generate revenues from the commercialization and sale of any of our product candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates.

 

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The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors including:

 

    per patient trial costs;

 

    the number of patients that participate in the trials;

 

    the number of sites included in the trials;

 

    the countries in which the trial is conducted;

 

    the length of time required to enroll eligible patients;

 

    the number of doses that patients receive;

 

    the drop-out or discontinuation rates of patients;

 

    potential additional safety monitoring or other studies requested by regulatory agencies;

 

    the duration of patient follow-up; and

 

    the efficacy and safety profile of the product candidate.

In addition, the probability of success for each product candidate will depend on numerous factors, including: competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.

General and Administrative

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, accounting, legal, business development and human resources functions. Other significant costs include facility costs not otherwise included in R&D expenses, legal fees, insurance costs, investor relations costs, patent costs and fees for accounting and consulting services.

We anticipate that our general and administrative expenses will continue near their current level through 2018 to support our continued R&D activities and potential commercialization of our product candidates. These expenses will likely include costs related to the hiring of additional personnel, fees to outside consultants, lawyers and accountants, and investor relations costs. In addition, if I.V. CR845, Oral CR845 or any future product candidate obtains regulatory approval for marketing, we expect to incur expenses associated with building a sales and marketing team.

Other Income

Other income consists of interest and dividend income earned on our cash, cash equivalents, marketable securities and restricted cash and realized gains and losses on the sale of marketable securities and property and equipment.

Benefit from Income Taxes

The benefit from income taxes relates to state R&D tax credits exchanged for cash pursuant to the Connecticut R&D Tax Credit Exchange Program, which permits qualified small businesses engaged in R&D activities within Connecticut to exchange their unused R&D tax credits for a cash amount equal to 65% of the value of the exchanged credits.

 

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Results of Operations

Comparison of the Three and Nine Months Ended September 30, 2017 and 2016

Revenue

 

     Three Months Ended September 30,                   Nine Months Ended September 30,         
         2017              2016          % change                2017                  2016          % change  
     Amounts in thousands                   Amounts in thousands         

License & milestone fees

   $ —        $ —          0      $ 530      $ —          100

Collaborative revenue

     —          —          0        313        —          100

Clinical compound revenue

     —          —          0        68        86        -21
  

 

 

    

 

 

         

 

 

    

 

 

    

Total revenue

   $ —        $ —          0      $ 911      $ 86        959
  

 

 

    

 

 

         

 

 

    

 

 

    

License and milestone fees revenue

License and milestone fees revenue for the nine months ended September 30, 2017 included $530 thousand of the $843 thousand sub-license fee earned by us in connection with Maruishi’s sub-license agreement with Kissei Pharmaceuticals, Co. Ltd. that was allocated to the license fee deliverable under the Maruishi Agreement. (see Note 10 of Notes to Condensed Financial Statements, Collaborations , in this Quarterly Report on Form 10-Q).

Collaborative revenue

Collaborative revenue for the nine months ended September 30, 2017 included $313 thousand of the $843 thousand sub-license fee earned by us in connection with Maruishi’s sub-license agreement with Kissei Pharmaceuticals, Co. Ltd. that was allocated to the R&D services deliverable under the Maruishi Agreement.

Clinical compound revenue

Clinical compound revenue for the nine months ended September 30, 2017 and 2016 resulted from the sale of clinical compound to Maruishi.

Research and Development Expense

 

     Three Months Ended September 30,                       Nine Months Ended September 30,              
     2017      2016          % change            2017      2016           % change  
     Amounts in thousands                       Amounts in thousands              

Direct clinical trial costs

   $ 5,654      $ 6,974          -19      $ 26,400      $ 19,970           32

Consultant services in support of clinical trials

     476        423          12        1,387        1,557           -11

Stock-based compensation

     619        375          65        1,784        867           106

Depreciation and amortization

     105        76          38        312        739           -58

Other R&D operating expenses

     2,297        1,823          26        7,065        5,843           21
  

 

 

    

 

 

           

 

 

    

 

 

       

Total R&D expense

   $ 9,151      $ 9,671          -5      $ 36,948      $ 28,976           28
  

 

 

    

 

 

           

 

 

    

 

 

       

For the three months ended September 30, 2017 compared to the three months ended September 30, 2016, the net decrease in direct clinical trial costs and related consultant costs primarily resulted from decreases totaling $4.5 million, including a decrease of $3.1 million, mainly from the Phase 2b clinical trial of Oral CR845 in OA patients and the Phase 2/3 I.V. CR845 clinical trial in patients with uremic pruritus, a decrease of $0.7 million of CR845 drug manufacturing costs and a decrease of $0.7 million for the cost of toxicology studies. Those decreases were partially offset by increases totaling $3.3 million, mainly from the Phase 2/3 I.V. CR845 adaptive pivotal clinical trial in postoperative pain, the 52-week Phase 3 safety study of I.V. CR845 in hemodialysis patients with CKD-aP, and the Phase 1 safety and pharmacokinetic trial of multiple doses of Oral CR845 in CKD patients undergoing hemodialysis.

 

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The increase in stock-based compensation expense relates primarily to an increase in the number of options outstanding as a result of increased employee headcount. The increase in depreciation and amortization expense reflects an increase in the cost of property and equipment. The increase in other R&D operating expenses was primarily the result of increases in personnel-related costs and in rent expense.

For the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016, the net increase in direct clinical trial costs and related consultant costs primarily resulted from increases totaling $14.7 million, mainly from the Phase 2/3 I.V. CR845 adaptive pivotal clinical trial in postoperative pain, the Phase 2b clinical trial of Oral CR845 in OA patients, the Phase 1 safety and pharmacokinetic trial of multiple doses of Oral CR845 in CKD patients undergoing hemodialysis, the Phase 2/3 I.V. CR845 clinical trial in patients with uremic pruritus and the 52-week Phase 3 safety study of I.V. CR845 in hemodialysis patients with uremic pruritus. Those costs were partially offset by a decrease of $5.2 million of CR845 drug manufacturing costs and a decrease of $2.7 million for the cost of toxicology studies. The increase in stock-based compensation expense relates primarily to an increase in the number of options outstanding as a result of increased employee headcount and stock option awards granted to non-employee consultants, which are marked to market each quarter, and resulted from an increase in the market price of our common stock. The decrease in depreciation and amortization expense primarily reflects the acceleration of amortization of the leasehold improvements at our Shelton, Connecticut facility related to research and development activities prior to the relocation of our corporate headquarters to Stamford, Connecticut in May 2016. The increase in other R&D operating expenses was primarily the result of an increase in personnel-related costs and costs of travel and conferences related to our clinical trial activities. Those increases were partially offset by a decrease in rent expense, primarily due to the Shelton Lease cease-use liability recorded in the 2016 period.

The following table summarizes our R&D expenses by product candidate for the three and nine months ended September 30, 2017 and 2016:

 

     Three Months Ended September 30,      Nine Months Ended September 30,  
     2017      2016      2017      2016  
     Amounts in thousands      Amounts in thousands  

External research and development expenses:

           

I.V. CR845 - Pain

   $ 2,291      $ 765      $ 11,021      $ 7,141  

I.V. CR845 - Pruritus

     1,274        2,754        5,640        5,105  

Oral CR845 - Pain

     1,287        3,800        7,242        9,203  

Oral CR845 - Pruritus

     1,278        78        3,884        78  

Internal research and development expenses

     3,021        2,274        9,161        7,449  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total research and development expenses

   $ 9,151      $ 9,671      $ 36,948      $ 28,976  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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General and Administrative Expenses

 

     Three Months Ended September 30,                Nine Months Ended September 30,             
     2017      2016          % change     2017      2016          % change  
     Amounts in thousands                Amounts in thousands             

Professional fees and public/investor relations

   $ 602      $ 509          18   $ 1,704      $ 1,584          8

Stock-based compensation

     1,475        402          267     2,736        1,104          148

Depreciation and amortization

     20        21          -5     58        607          -90

Other G&A operating expenses

     1,708        1,170          46     4,379        3,900          12
  

 

 

    

 

 

        

 

 

    

 

 

      

Total G&A expense

   $ 3,805      $ 2,102          81   $ 8,877      $ 7,195          23
  

 

 

    

 

 

        

 

 

    

 

 

      

For the three months ended September 30, 2017 compared to the three months ended September 30, 2016, the increase in professional fees and public/investor relations expenses was due primarily to an increase in legal fees and accounting and audit fees, which were partially offset by a decrease in consultant costs. The increase in stock-based compensation resulted from increased employee headcount, the acceleration of vesting of outstanding stock option awards, upon the retirement of our former Chief Financial Officer, and stock option awards granted to non-employee consultants, which are marked to market each quarter, and resulted from an increase in the market price of our common stock. The increase in other G&A operating expenses was primarily the result of an increase in personnel-related costs and an increase in rent expense.

For the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016, the increase in professional fees and public/investor relations was due primarily to an increase in public/investor relations costs and legal fees, which were partially offset by a decrease in consultant costs, accounting and audit fees and patent costs. The increase in stock-based compensation primarily resulted from increased employee headcount, the acceleration of vesting of outstanding stock option awards, upon the retirement of our former Chief Financial Officer, and stock option awards granted to non-employee consultants, which are marked to market each quarter, and resulted from an increase in the market price of our common stock. The decrease in depreciation and amortization expense reflects the acceleration of amortization of our leasehold improvements at our Shelton, Connecticut facility related to general and administrative activities prior to the relocation of our corporate headquarters in May 2016. The increase in other G&A operating expenses was primarily the result of an increase in personnel-related costs, partially offset by a decrease in rent expense, primarily due to the Shelton Lease cease-use liability recorded in the 2016 period.

Other Income

 

     Three Months Ended September 30,            Nine Months Ended September 30,         
     2017      2016      % change     2017      2016      % change  
     Amounts in thousands            Amounts in thousands         

Other Income

   $ 367      $ 176        108   $ 788      $ 498        58

During the three months ended September 30, 2017 compared to the three months ended September 30, 2016, the increase in other income was primarily due to an increase in dividend and interest income resulting from higher interest rates on a higher average balance of our portfolio of investments in the 2017 period.

During the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016, the increase in other income was primarily due to an increase in dividend and interest income resulting from higher interest rates on a slightly lower average balance of our portfolio of investments in the 2017 period.

 

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Benefit from Income Taxes

For the three months ended September 30, 2017 and 2016, pre-tax losses were $12.6 million and $11.6 million, respectively, and we recognized a benefit from income taxes of $145 thousand and $55 thousand, respectively.

For the nine months ended September 30, 2017 and 2016, pre-tax losses were $44.1 million and $35.6 million, respectively, and we recognized a benefit from income taxes of $178 thousand and $279 thousand, respectively.

The benefit from income taxes relates to state R&D tax credits exchanged for cash pursuant to the Connecticut R&D Tax Credit Exchange Program, as discussed above. We recognized a full valuation allowance against deferred tax assets at September 30, 2017 and December 31, 2016.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception and through September 30, 2017, we have raised an aggregate of approximately $324.5 million to fund our operations, including (1) net proceeds of $217.7 million from the sale of shares of our common stock in three public offerings, including our initial public offering; (2) proceeds of $73.3 million from the sale of shares of our convertible preferred stock and from debt financings prior to our initial public offering; and (3) payments of $33.5 million under our license agreements, primarily with Maruishi and CKDP, and an earlier product candidate for which development efforts ceased in 2007.

In order to fund future operations, including our planned clinical trials, we filed a shelf registration statement on Form S-3 (File No. 333-216657), which the Securities and Exchange Commission, or SEC, declared effective on March 24, 2017. The shelf registration statement provides for aggregate offerings of up to $250 million of common stock, preferred stock, debt securities, warrants or any combination thereof. The securities registered under this shelf registration statement include unsold securities that had been registered under our previous shelf registration statement (File No. 333-203072) that was declared effective on May 13, 2015.

On April 5, 2017, we completed a public offering of 5,117,500 shares of our common stock, including 667,500 shares sold upon the full exercise by the underwriters of their option to buy additional shares. The offering was conducted pursuant to the shelf registration statement on Form S-3, which was filed on March 13, 2017 and declared effective by the SEC on March 24, 2017, and a related prospectus supplement dated March 30, 2017, filed with the SEC on March 31, 2017. We received gross proceeds from the offering of approximately $92.1 million, or net proceeds of $86.2 million after deducting the underwriting discounts and commissions and offering expenses paid by us. The proceeds of the offering are being used to fund our clinical and research development activities, including the completion of the Phase 3 program for I.V. CR845 in uremic pruritus, two Phase 3 trials of I.V. CR845 in acute pain and additional trials of Oral CR845 in other diseases associated with pruritus as well as for working capital and general corporate purposes.

We may offer additional securities under our shelf registration statement from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders. We believe that the use of a shelf registration statement provides us with the flexibility to raise additional capital to finance our operations as needed.

As of September 30, 2017, we had $103.0 million in unrestricted cash and cash equivalents and available-for-sale marketable securities, which we believe will be sufficient to fund our currently anticipated operating expenses and capital expenditures into 2019, without giving effect to any potential milestone payments we may receive under our collaboration agreements with Maruishi and CKDP.

In addition, under the Maruishi Agreement, we are potentially eligible to earn up to an aggregate of $6.0 million in clinical development milestones and $4.5 million in regulatory milestones, before any foreign exchange adjustment, as well as tiered royalties, with percentages ranging from the low double digits to the low twenties, based on net sales of products containing CR845 in Japan, if any, and share in any sub-license fees. During 2014 and 2015, we earned a total of $2.2 million, net of contractual foreign currency exchange adjustments of $0.3 million, related to two milestones involving clinical trials in Japan of CR845 in acute post-operative pain and for the treatment of uremic pruritus.

 

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The next potential milestone payment that we could be entitled to receive under the Maruishi Agreement will be for a clinical development milestone for completion by us in the United States of the first Phase 3 pivotal trial of CR845 in acute pain. If achieved, this milestone will result in a payment of $1.0 million, before any foreign exchange adjustment, being due to us.

Under the CKDP Agreement, we are potentially eligible to earn up to an aggregate of $2.25 million in clinical development milestones and $1.5 million in regulatory milestones, before South Korean withholding tax, as well as tiered royalties with percentages ranging from the high single digits to the high teens, based on net sales of products containing CR845 in South Korea, if any, and share in any sub-license fees. During 2012 and 2015, we earned a total of $1.25 million, net of South Korean withholding tax of $0.25 million, related to four milestones involving clinical trials in the United States of CR845 in acute post-operative pain and for the treatment of uremic pruritus.

The next potential milestone payment that we could be entitled to receive under the CKDP Agreement will be for a clinical development milestone for the completion by us in the United States of a Phase 3 trial of CR845 in uremic pruritus. If achieved, this milestone will result in a payment $750 thousand, before South Korean withholding tax, being due to us.

Our ability to earn these payments and their timing is dependent upon the outcome of I.V. and Oral CR845 development activities and, potentially, commercialization. However, our receipt of any further such amounts is uncertain at this time and we may never receive any more of these amounts.

Funding Requirements

Our primary uses of capital have been, and we expect will continue to be, compensation and related expenses, third-party clinical R&D services, clinical costs, legal and other regulatory expenses and general overhead costs. In the past, we have also previously used capital for laboratory and related supplies.

Since inception, we have incurred significant operating and net losses. Our net losses were $43.9 million and $35.3 million for the nine months ended September 30, 2017 and 2016, respectively. As of September 30, 2017, we had an accumulated deficit of $206.2 million. We expect to continue to incur significant expenses and operating and net losses over at least the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials, the receipt of additional milestone payments, if any, under our collaborations with Maruishi and CKDP, the receipt of payments under any future collaborations we may enter into, and our expenditures on other R&D activities.

We anticipate that our expenses will increase as we:

 

    continue our I.V. CR845 pivotal clinical trial program in acute pain;

 

    continue the development of I.V. CR845 for uremic pruritus;

 

    continue the development of Oral CR845 for acute and chronic pain;

 

    continue the development of Oral CR845 for uremic pruritus and other diseases associated with pruritus;

 

    continue the R&D of CR701 and any potential future product candidates;

 

    seek regulatory approvals for I.V. CR845 and any product candidates that successfully complete clinical trials;

 

    establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any products for which we may obtain regulatory approval;

 

    maintain, expand and protect our global intellectual property portfolio;

 

    hire additional clinical, quality control and scientific personnel; and

 

    add operational, financial and management information systems and personnel, including personnel to support our drug development and potential future commercialization efforts.

The successful development of any of our product candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the development of I.V. CR845, Oral CR845 or our other current and future product candidates. We are also unable to predict when, if ever, we will generate any further material net cash inflows from CR845. This is due to the numerous risks and uncertainties associated with developing medicines, including the uncertainty of:

 

    successful enrollment in, and completion of clinical trials;

 

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    receipt of marketing approvals from applicable regulatory authorities;

 

    establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;

 

    obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;

 

    launching commercial sales of the products, if and when approved, whether alone or in collaboration with others;

 

    achieving meaningful penetration in the markets which we seek to serve; and

 

    obtaining adequate coverage or reimbursement by third parties, such as commercial payers and government healthcare programs, including Medicare and Medicaid.

A change in the outcome of any of these variables with respect to the development of I.V. CR845, Oral CR845 or any of our future product candidates would significantly change the costs and timing associated with the development of that product candidate.

Because our product candidates are still in clinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements, including our existing collaboration agreements with Maruishi and CKDP.

We will require additional capital beyond our current balances of cash and cash equivalents and available-for-sale marketable securities and anticipated amounts as described above, and this additional capital may not be available when needed, on reasonable terms, or at all. In particular, because we do not have sufficient financial resources to meet all of our development objectives, especially the completion of our planned development of Oral CR845, we will need to raise additional capital. If we are not able to do so, we could be required to postpone, scale back or eliminate some, or all, of these objectives. To the extent that we raise additional capital through the future sale of equity or convertible debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of debt securities, these securities could contain covenants that would restrict our operations. If we raise additional funds through collaboration arrangements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Outlook

Based on timing expectations and projected costs for our current clinical development plans, which include completing required trials for I.V. CR845 in postoperative pain to enable an NDA submission; completing the Phase 3 program for I.V. CR845 in uremic pruritus; and completing additional trials of Oral CR845 in uremic pruritus and other diseases associated with pruritus, we expect that our existing cash and cash equivalents and available-for-sale marketable securities as of September 30, 2017 will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2019, without giving effect to any potential milestone payments we may receive under our collaboration agreements with Maruishi and CKDP. Because the process of testing product candidates in clinical trials is costly and the timing of progress in these trials is uncertain, it is possible that the assumptions upon which we have based this estimate may prove to be wrong, and we could use our capital resources sooner than we presently expect.

 

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Cash Flows

The following is a summary of the net cash flows provided by (used in) our operating, investing and financing activities for the nine months ended September 30, 2017 and 2016:

 

     Nine Months Ended September 30,  
             2017                            2016          
     Amounts in thousands  

Net cash used in operating activities

   $ (43,414      $ (34,193

Net cash (used in) provided by investing activities

     (44,626        24,478  

Net cash provided by financing activities

     87,740          40  
  

 

 

      

 

 

 

Net decrease in cash and cash equivalents

   $ (300      $ (9,675
  

 

 

      

 

 

 

Net cash used in operating activities

Net cash used in operating activities for the nine months ended September 30, 2017 consisted primarily of a net loss of $43.9 million, and a $4.1 million outflow from net changes in operating assets and liabilities, partially offset by a $4.6 million cash inflow from net non-cash charges. The net change in operating assets and liabilities primarily consisted of a cash outflow of $4.3 million from a decrease in accounts payable and accrued expenses. That cash outflow was partially offset by a cash inflow of $0.2 million due to a decrease in income tax receivable from the State of Connecticut under the Connecticut R&D Tax Credit Exchange Program. Net non-cash charges primarily consisted of $4.5 million of stock-based compensation expense (including $0.5 million related to modification of equity awards) and $0.4 million of depreciation and amortization expense, partially offset by $0.3 million of accretion/amortization on available-for-sale marketable securities.

Net cash used in operating activities for the nine months ended September 30, 2016 consisted primarily of a net loss of $35.3 million and a $1.8 million cash outflow from net changes in operating assets and liabilities, partially offset by a $2.9 million cash inflow from net non-cash charges. The net change in operating assets and liabilities primarily consisted of a cash outflow of $3.1 million from an increase in prepaid expense, primarily related to increases in prepaid clinical costs and prepaid insurance and a cash outflow of $0.3 million due to an increase in income tax receivable from the State of Connecticut under the Connecticut R&D Tax Credit Exchange Program. Those cash outflows were partially offset by a cash inflow of $1.6 million from an increase in accounts payable and accrued expenses. Net non-cash charges primarily consisted of depreciation and amortization expense of $1.3 million and stock-based compensation expense of $2.0 million, partially offset by deferred rent costs of $0.2 million and accretion/amortization on available-for-sale marketable securities of $0.2 million.

Net cash (used in) provided by investing activities

Net cash used in investing activities for the nine months ended September 30, 2017 primarily included cash outflows of $115.7 million for the purchase of available-for-sale marketable securities, partially offset by cash inflows of $65.4 million from maturities of available-for-sale marketable securities and $5.7 million from the sale of available-for-sale marketable securities.

Net cash provided by investing activities for the nine months ended September 30, 2016 primarily included cash inflows of $59.6 million from maturities of available-for-sale marketable securities and $23.4 million from the sale of available-for-sale marketable securities. Those cash inflows were partially offset by cash outflows of $57.1 million from the purchase of available-for-sale marketable securities, $0.6 million of cash paid for purchase of property and equipment at our corporate headquarters in Stamford, Connecticut and $0.8 million of additional restricted cash related to the Stamford Lease.

Net cash provided by financing activities

Net cash provided by financing activities for the nine months ended September 30, 2017 consisted of proceeds, net of issuance costs, of $86.2 million from our public offering of common stock completed in April 2017 and $1.5 million received from the exercise of stock options.

Net cash provided by financing activities for the nine months ended September 30, 2016 consisted primarily of proceeds of $40 thousand received from the exercise of stock options.

Significant Contractual Obligations and Commitments

Contractual obligations and commitments as of September 30, 2017 consisted of operating lease obligations in connection with our operating facilities in Shelton, Connecticut and Stamford, Connecticut. See Note 14 of Notes to Condensed Financial Statements, Commitments and Contingencies , in this Quarterly Report on Form 10-Q.

 

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Recent Accounting Pronouncements

Please refer to Note 2 of Notes to Condensed Financial Statements, Basis of Presentation , in this Quarterly Report on Form 10-Q.

Off-Balance Sheet Arrangements

We did not have during the periods presented in our condensed financial statements included in this report, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

Discussion of Critical Accounting Policies

The preparation of financial statements in conformity with GAAP requires us to use judgment in making certain estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in our condensed financial statements and accompanying notes. Critical accounting policies are those that are most important to the portrayal of our financial condition and results of operations and require difficult, subjective and complex judgments by management in order to make estimates about the effect of matters that are inherently uncertain. During the nine months ended September 30, 2017, there were no significant changes to our critical accounting policies from those described in our Annual Report on Form 10-K for the year ended December 31, 2016.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Interest Rate Risk

As of September 30, 2017, we invested a majority of our cash reserves in a variety of available-for-sale marketable securities, including a money market fund and investment-grade debt instruments, principally corporate notes, commercial paper and U.S. government-sponsored entities, and in cash equivalents. See Note 3 of Notes to Condensed Financial Statements, Available-for-Sale Marketable Securities , in this Quarterly Report on Form 10-Q for details about our available-for-sale marketable securities.

Information about our market risks are disclosed in Part II, Item 7A, Quantitative and Qualitative Disclosures About Market Risk, of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016. There have been no material changes to our market risks as of September 30, 2017.

As of September 30, 2017, we had invested $91.2 million of our cash reserves in such marketable securities. Those marketable securities include $48.3 million of investment grade debt instruments with an average interest rate of approximately 1.27% and maturities through June 2018 and $42.9 million of money market funds with an average interest rate of 1.02%. As of December 31, 2016, we had invested $46.2 million of our cash reserves in such marketable securities. Those marketable securities include $37.9 million of investment grade debt instruments with an average interest rate of approximately 1.0% and maturities through August 2017 and $8.3 million of money market funds with an average interest rate of 0.92%.

We maintain an investment portfolio in accordance with our investment policy, which includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification. The primary objectives of our investment policy are to preserve principal and to maintain proper liquidity to meet operating needs. Our investments are subject to interest rate risk and will decrease in value if market interest rates increase. However, due to the conservative nature of our investments and relatively short duration, interest rate risk is mitigated.

Duration is a sensitivity measure that can be used to approximate the change in the fair value of a security that will result from a change in interest rates. Applying the duration model, a hypothetical 10% increase in interest rates as of September 30, 2017 and December 31, 2016 would have resulted in immaterial decreases in the fair values of our portfolio of marketable securities at those dates. We do not currently use interest rate derivative instruments to manage exposure to interest rate changes.

 

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Credit Quality Risk

Although our investments are subject to credit risk, our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure from any single issue, issuer or type of investment. Nonetheless, deterioration of the credit quality of an investment security subsequent to purchase may subject us to the risk of not being able to recover the full principal value of the security.

Item 4. Controls and Procedures .

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2017. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of September 30, 2017, our disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC, and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosures.

Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(f) and 15d-15(f) of the Exchange Act that occurred during the quarter ended September 30, 2017 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Limitations on Controls and Procedures

Management, including our Chief Executive Officer and Chief Financial Officer, recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Because of the inherent limitations in all control systems, no evaluation of controls and procedures can provide absolute assurance that all control issues and instances of fraud, if any, within Cara have been detected.

 

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PART II

OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we are subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceedings against us that we believe could have a material adverse effect on our business, operating results or financial condition.

Item 1A. Risk Factors .

Please refer to Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 10, 2017, for a description of certain significant risks and uncertainties to which our business, operations and financial condition are subject. During the nine months ended September 30, 2017, we did not identify any additional risk factors or any material changes to the risk factors discussed in the Annual Report on Form 10-K for the year ended December 31, 2016, other than as set forth below.

We have been granted breakthrough therapy designation for I.V. CR845, however, it may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that I.V. CR845 will receive marketing approval.

In June 2017, the FDA granted breakthrough therapy designation for I.V. CR845 for the treatment of moderate-to-severe uremic pruritus in CKD patients undergoing hemodialysis. A breakthrough therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs designated as breakthrough therapies by the FDA may also be eligible for accelerated approval if the relevant criteria are met.

The receipt of a breakthrough therapy designation for I.V. CR845 for the treatment of moderate-to-severe uremic pruritus in CKD patients undergoing hemodialysis may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, the FDA may later decide that it no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds .

None.

Item 3. Defaults upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

None.

 

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Item 6. Exhibits .

 

Exhibit No.

  

Description of Exhibit

    3.1    Amended and Restated Certificate of Incorporation (1)
    3.2    Amended and Restated Bylaws (2)
  10.1    Employment Agreement with Mani Mohindru, Ph.D. (3)
  31.1    Certification of Chief Executive Officer of Cara Therapeutics, Inc. pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934.
  31.2    Certification of Chief Financial Officer of Cara Therapeutics, Inc. pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934.
  32.1*    Certifications of Chief Executive Officer and Chief Financial Officer of Cara Therapeutics, Inc. pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section  906 of the Sarbanes-Oxley Act of 2002.
101    Interactive Data File
101.CAL    XBRL Taxonomy Extension Calculation Linkbase.
101.INS    XBRL Instance Document.
101.LAB    XBRL Taxonomy Extension Label Linkbase.
101.PRE    XBRL Taxonomy Extension Presentation Linkbase.
101.SCH    XBRL Taxonomy Extension Schema Linkbase.
101.DEF    XBRL Definition Linkbase Document.

 

(1) Filed as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-36279) filed with the Securities and Exchange Commission on February 7, 2014 and incorporated herein by reference.
(2) Filed as Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-36279) filed with the Securities and Exchange Commission on February 7, 2014 and incorporated herein by reference.
(3) Filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-36279) filed with the Securities and Exchange Commission on August 4, 2017 and incorporated herein by reference.
* These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

    CARA THERAPEUTICS, INC.
Date: November 2, 2017     By  

/s/ Derek Chalmers

    Derek Chalmers, Ph.D., D.Sc.
    President and Chief Executive Officer
    (Principal Executive Officer)
Date: November 2, 2017     By  

/s/ Mani Mohindru

    Mani Mohindru, Ph.D.
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

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EXHIBIT 31.1

Certification of Chief Executive Officer Pursuant to

Rule 13a-14(a) under the Securities Exchange Act

of 1934, as Adopted Pursuant to

Section 302 of the Sarbanes-Oxley Act of 2002

I, Derek Chalmers, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Cara Therapeutics, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 2, 2017     By:  

/s/ Derek Chalmers

      DEREK CHALMERS, Ph.D., D.Sc.
      CHIEF EXECUTIVE OFFICER

EXHIBIT 31.2

Certification of Chief Financial Officer Pursuant to

Rule 13a-14(a) under the Securities Exchange Act

of 1934, as Adopted Pursuant to

Section 302 of the Sarbanes-Oxley Act of 2002

I, Mani Mohindru, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Cara Therapeutics, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 2, 2017     By:  

/s/ Mani Mohindru

      MANI MOHINDRU, Ph.D.
      CHIEF FINANCIAL OFFICER

EXHIBIT 32.1

CERTIFICATIONS OF

CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER

OF CARA THERAPEUTICS, INC.

PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of Cara Therapeutics, Inc. (the “Company”) for the quarter ended September 30, 2017, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), Derek Chalmers, Ph.D., D.Sc., as Chief Executive Officer of the Company, and Mani Mohindru, Ph.D., as Chief Financial Officer of the Company, each hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of his knowledge, based upon a review of the Report:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ DEREK CHALMERS

Name: Derek Chalmers, Ph.D., D.Sc.
Title: Chief Executive Officer
Date: November 2, 2017

/s/ MANI MOHINDRU

Name: Mani Mohindru, Ph.D.
Title: Chief Financial Officer
Date: November 2, 2017