Cara Therapeutics
May 4, 2017

Cara Therapeutics Reports First Quarter 2017 Financial Results

- Reported statistically significant positive top-line results from Part A of Phase 2/3 trial for I.V. CR845 in chronic kidney disease (CKD)-associated pruritus - 

- Completed public offering of common stock, raising net proceeds of $86.5 million

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

STAMFORD, Conn., May 04, 2017 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced financial results for the first quarter ended March 31, 2017.

"During the quarter, we were pleased to announce positive data from Part A of our Phase 2/3 trial of I.V CR845 in CKD-associated pruritus, where we observed sustained clinical benefit over the entire two-month treatment period, supporting the potential viability of I.V CR845 as a long-term therapeutic approach for this unmet medical need," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "In addition to completing a successful follow on offering to support operations into 2019, our other late-stage trials continue to enroll well, and we look forward to completing an interim assessment in our adaptive Phase 3 postoperative pain trial of I.V. CR845, as well as reporting data from our Phase 2b chronic pain trial of Oral CR845 this quarter."

First Quarter and Recent Business Highlights

Expected Upcoming Milestones

First Quarter 2017 Financial Results

Net Loss: The Company reported a net loss of $22.2 million, or $0.81 per basic and diluted share, for the first quarter of 2017 compared to a net loss of $10.7 million, or $0.39 per basic and diluted share, for the same period of 2016.

Revenues: In the first quarter of 2017, the Company earned revenue of $843 thousand in connection with the sub-license by Maruishi Pharmaceutical Co. Ltd., or Maruishi, of the Company's intellectual property related to CR845 for use in patients with uremic pruritus in Japan. Of that amount, $530 thousand was recognized as milestone and license fees revenue and $313 thousand as collaborative revenue. In addition, the Company recognized $68 thousand and $7 thousand from the sale of clinical compound to Maruishi during the first quarter of 2017 and 2016, respectively.

Research and Development (R&D) Expenses: R&D expenses were $20.8 million in the first quarter of 2017 compared to $8.5 million in the same period of 2016. The higher R&D expenses in the first quarter of 2017 were principally due to a net increase in direct clinical trial costs and an increase in payroll and related costs for R&D personnel.

General and Administrative (G&A) Expenses: G&A expenses were $2.4 million in both the first quarter of 2017 and 2016, representing decreases in professional fees and public/investor relations costs and depreciation and amortization expense, which were offset by increases in stock-based compensation and payroll and related costs.

Other Income: Other income was $90,000 in the first quarter of 2017 compared to $149,000 in the first quarter of 2016. The decrease in 2017 was primarily due to lower dividend income earned on the lower average balance of our portfolio of investments.

Cash and Cash Equivalents and Marketable Securities Position: At March 31, 2017, cash and cash equivalents and marketable securities totaled $36.8 million compared to $58.3 million at December 31, 2016. The decrease in the balance of cash and cash equivalents and marketable securities primarily resulted from cash used in operations of $21.6 million

In April 2017, the Company completed a public offering of 5,117,500 shares of common stock, including full exercise of the underwriters' option to purchase additional shares at $18.00 per share, raising approximately $86.5 million in net proceeds after deducting underwriting discounts and commissions but before deducting estimated offering expenses payable by the Company.

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 will be sufficient for the Company to fund its operating expenses and capital expenditure requirements into 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 2017 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 10052639. 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 biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates, led by CR845, that target the body's peripheral nervous system and have demonstrated, in Phase 2 trials, preliminary efficacy in patients with moderate-to-severe pain and pruritus without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

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, 2016 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

CARA THERAPEUTICS, INC. 
STATEMENTS OF OPERATIONS 
(amounts in thousands, except share and per share data) 
(unaudited) 
        
   Three Months Ended March 31,   
    2017   2016   
    





  
Revenue:      
 License and milestone fees $530   $-   
 Collaborative revenue  313   -   
 Clinical compound revenue  68   7   
Total revenue  911   7   
        
Operating expenses:      
 Research and development  20,836   8,546   
 General and administrative  2,400   2,447   
Total operating expenses  23,236   10,993   
Operating loss  (22,325)  (10,986)  
        
Other income  90   149   
Loss before benefit from income taxes  (22,235)  (10,837)  
         
Benefit from income taxes  31    145   
Net loss $(22,204) $(10,692)  
        
Net loss per share :      
Basic and Diluted $(0.81) $(0.39)  
        
Weighted average shares:      
Basic and Diluted  27,299,678   27,259,589   


CARA THERAPEUTICS, INC. 
BALANCE SHEETS 
(in thousands) 
(unaudited) 
       
   March 31, December 31, 
    2017   2016  
       
Assets     
Current assets:     
 Cash and cash equivalents $5,306  $12,092  
 Marketable securities  31,504   46,184  
 Income tax receivable  558   852  
 Other receivables  984   87  
 Prepaid expenses  1,979   1,530  
 Restricted cash, current  700   700   
Total current assets  41,031   61,445  
Property and equipment, net  1,499   1,614  
Restricted cash   769   769  
Total assets $43,299  $63,828  
       
Liabilities and stockholders' equity     
Current liabilities:     
 Accounts payable and accrued expenses $12,512  $11,533  
Total current liabilities  12,512   11,533  
       
Deferred lease obligation  1,518   1,570  
        
Commitments and contingencies     
       
Stockholders' equity:     
 Preferred stock  -   -  
 Common stock  27    27  
 Common stock subscribed in a follow-on offering  5    -  
 Additional paid-in capital  300,151   212,866  
 Subscriptions receivable  (86,518)  -  
 Accumulated deficit  (184,420)  (162,171) 
 Accumulated other comprehensive income  24   3  
Total stockholders' equity  29,269   50,725  
Total liabilities and stockholders' equity $43,299  $63,828  

 

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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Source: Cara Therapeutics Inc.

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