8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) May 9, 2018

 

 

CARA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36279   75-3175693

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

4 Stamford Plaza

107 Elm Street 9th Floor

Stamford, Connecticut

    06902

(Address of principal executive offices)

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

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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.  ☒.

 

 

 


Item 2.02. Results of Operations and Financial Condition.

Cara Therapeutics, Inc. (the “Company”) issued a press release on May 9, 2018 announcing its financial results for the first quarter ended March 31, 2018. A copy of the press release is being furnished to the Securities and Exchange Commission as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference to this Item 2.02.

The information furnished pursuant to this Item 2.02 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission under the Exchange Act or the Securities Act of 1933, whether made before or after the date hereof, regardless of any general incorporation language in such a filing, except as expressly set forth by specific reference in such a filing. Except as required by law, we undertake no duty or obligation to publicly update or revise the information so furnished.

 

Item 9.01. Financial Statements and Exhibits.

(d)     Exhibits

 

Exhibit No.   

Description

99.1    Earnings Press Release Q1 2018


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 hereunto duly authorized.

 

CARA THERAPEUTICS, INC.
By:  

/s/ MANI MOHINDRU

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

Date: May 9, 2018

EX-99.1

Exhibit 99.1

 

LOGO

Cara Therapeutics Reports First Quarter 2018 Financial Results

– Conference call today at 4:30 p.m. ET –

STAMFORD, Conn., May 9, 2018 – Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus and pain by selectively targeting peripheral kappa opioid receptors, today announced financial results and operational highlights for the first quarter ended March 31, 2018.

“During the quarter, we were pleased with the progress made in building out our pruritus pipeline, headlined by the initiation of our pivotal U.S. Phase 3 trial of KORSUVA injection in hemodialysis patients with chronic kidney disease-associated pruritus,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We look forward to the continued development of our other pruritus clinical programs, including Oral KORSUVA for the treatment of pruritus in pre-dialysis chronic kidney disease and chronic liver disease patient populations, and will be reporting on the progress of these studies later this year. In addition, we have now completed enrollment in our adaptive Phase 3 trial in acute post-operative pain and expect to announce top-line data later this quarter.”

First Quarter and Recent Developments:

KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis

In January 2018, the Company initiated the first pivotal Phase 3 efficacy trial (KALM-1) of KORSUVA (CR845/difelikefalin) injection in the United States for the treatment of CKD-aP in patients undergoing hemodialysis. In addition, the Company is conducting a 52-week Phase 3 safety study of KORSUVA (CR845/difelikefalin) injection in patients undergoing hemodialysis with CKD-aP.

Oral KORSUVA: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Non-Hemodialysis

The open label, dose-escalating Phase 1 pharmacokinetic (PK), safety and tolerability trial continues to enroll moderate and severe CKD patients in escalating dose cohorts. Top-line data are expected in the second quarter of 2018.


Oral KORSUVA: Chronic Liver Disease-Associated Pruritus (CLD-aP)

In February 2018, the Company announced dosing of the first patient in a Phase 1 PK and safety trial of Oral KORSUVA in patients with CLD. Data from this trial will inform the design/doses for the planned Phase 2 trial of Oral KORSUVA in patients with moderate-to-severe CLD-aP.

I.V. CR845/Difelikefalin: Acute Post-Operative Pain

Enrollment is complete in the adaptive Phase 3 trial of I.V. CR845 for the treatment of acute post-operative pain in patients undergoing abdominal surgery. Data from this trial are expected in the second quarter of 2018.

Upcoming Activities

The Company expects to make presentations at the following conferences through June 2018:

 

    International Investigative Dermatology Meeting, May 16-19, 2018

 

    Jefferies 2018 Global Healthcare Conference, June 5-8, 2018

 

    Cantor Dermatology & Aesthetics Summit, June 19, 2018

First Quarter 2018 Financial Results

Net Loss: The Company reported a net loss of $16.8 million, or $0.51 per basic and diluted share, for the first quarter of 2018 compared to a net loss of $22.2 million, or $0.81 per basic and diluted share, for the same quarter of 2017.

Revenues: The Company did not recognize any revenue during the first quarter of 2018. Total revenue in the first quarter of 2017 was $911,000, which consisted of:

 

  (1) License and milestone fees revenue of $530,000 related to a sub-license fee earned from Maruishi Pharmaceuticals, or Maruishi, in connection with its sub-license agreement with Kissei Pharmaceuticals.

 

  (2) Collaborative revenue of $313,000 related to a sub-license fee earned from Maruishi; and

 

  (3) Clinical compound revenue of $68,000 from the sale of clinical compound to Maruishi.

Research and Development (R&D) Expenses: R&D expenses were $13.4 million in the first quarter of 2018 compared to $20.8 million in the same period of 2017. The lower R&D expenses in 2018 were principally due to a net decrease in direct clinical trial costs, which were partially offset by increases in stock compensation expense and payroll and related costs for R&D personnel.

General and Administrative (G&A) Expenses: G&A expenses were $3.7 million during the first quarter of 2018 compared to $2.4 million in the same period of 2017. The increase in 2018 was primarily due to increases in stock compensation expense and payroll and related costs for G&A personnel.

 

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Other Income: Other income was $311,000 in the first quarter of 2018 compared to $90,000 in the same period of 2017. The increase in 2018 was primarily due to higher dividend and interest income resulting from a higher average balance of the Company’s portfolio of investments in the 2018 period.

Cash and Cash Equivalents and Marketable Securities Position: At March 31, 2018, cash and cash equivalents and marketable securities totaled $74.5 million compared to $92.6 million at December 31, 2017. The decrease in the balance of cash and cash equivalents and marketable securities primarily resulted from cash used in operations of $18.5 million, partially offset by proceeds of $0.3 million from the exercise of stock options.

Financial Guidance

Based on timing expectations and projected costs for current clinical development plans, Cara expects that its existing cash and cash equivalents and available-for-sale marketable securities as of March 31, 2018 will be sufficient to fund its operating expenses and capital expenditures into the first half of 2019, without giving effect to any potential milestone payments under existing collaborations.

Conference Call

Cara management will host a conference call today at 4:30 p.m. ET to discuss first quarter 2018 financial results and provide a business update.

To participate in the conference call, please dial 855-445-2816 (domestic) or 484-756-4300 (international) and refer to conference ID 1264618. A live webcast of the call can be accessed under “Events and Presentations” in the News & Investors section of the Company’s website at www.CaraTherapeutics.com.

An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus and pain by selectively targeting peripheral kappa opioid receptors (KORs). Cara is developing a novel and proprietary class of product candidates, led by KORSUVATM (CR845/difelikefalin), a first-in-class KOR agonist that targets the body’s peripheral nervous system, as well as certain immune cells. In Phase 2 trials, KORSUVA injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) and is currently being investigated in Phase 3 trials in hemodialysis patients with CKD-aP. Additionally, CR845/difelikefalin has demonstrated efficacy in patients with moderate-to-severe pain, without inducing many of the undesirable side effects typically associated with currently available opioid pain therapeutics.

 

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The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing of the Company’s planned clinical trials, the potential results of ongoing and planned clinical trials, future regulatory and development milestones for the Company’s product candidates and the Company’s expected cash reach. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Financial tables follow

 

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CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS

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

(unaudited)

 

     Three Months Ended March 31,  
     2018     2017  

Revenue:

    

License and milestone fees

   $ —       $ 530  

Collaborative revenue

     —         313  

Clinical compound revenue

     —         68  
  

 

 

   

 

 

 

Total revenue

     —         911  

Operating expenses:

    

Research and development

     13,427       20,836  

General and administrative

     3,697       2,400  
  

 

 

   

 

 

 

Total operating expenses

     17,124       23,236  
  

 

 

   

 

 

 

Operating loss

     (17,124     (22,325

Other income

     311       90  
  

 

 

   

 

 

 

Loss before benefit from income taxes

     (16,813     (22,235

Benefit from income taxes

     46       31  
  

 

 

   

 

 

 

Net loss

   $ (16,767   $ (22,204
  

 

 

   

 

 

 

Net loss per share :

    

Basic and Diluted

   $ (0.51   $ (0.81

Weighted average shares:

    

Basic and Diluted

     32,681,661       27,299,678  

 

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CARA THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands)

(unaudited)

 

     March 31,     December 31,  
     2018     2017  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 11,877     $ 9,388  

Marketable securities

     62,644       83,181  

Income tax receivable

     777       731  

Other receivables

     84       123  

Prepaid expenses

     3,431       1,635  
  

 

 

   

 

 

 

Total current assets

     78,813       95,058  

Property and equipment, net

     1,053       1,177  

Restricted cash

     769       769  
  

 

 

   

 

 

 

Total assets

   $ 80,635     $ 97,004  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable and accrued expenses

   $ 6,875     $ 8,506  
  

 

 

   

 

 

 

Total current liabilities

     6,875       8,506  

Deferred lease obligation

     1,657       1,718  

Commitments and contingencies

    

Stockholders’ equity:

    

Preferred stock

     —         —    

Common stock

     33       33  

Additional paid-in capital

     309,292       307,158  

Accumulated deficit

     (237,108     (220,341

Accumulated other comprehensive loss

     (114     (70
  

 

 

   

 

 

 

Total stockholders’ equity

     72,103       86,780  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 80,635     $ 97,004  
  

 

 

   

 

 

 

INVESTOR CONTACT:

Michael Schaffzin

Stern Investor Relations, Inc.

212-362-1200

michael@sternir.com

MEDIA CONTACT:

Annie Starr

6 Degrees

973-415-8838

astarr@6degreespr.com

 

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