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 7, 2019

 

 

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.  ☒.

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol

 

Name of each exchange

on which registered

Common Stock, par value $0.001 per share   CARA   The Nasdaq Stock Market LLC

 

 

 


Item 2.02.

Results of Operations and Financial Condition.

On May 7, 2019, Cara Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2019. 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, including Exhibit 99.1, 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, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such a filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d)     Exhibits

 

Exhibit No.    Description
99.1    Press Release dated May 7, 2019


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 7, 2019

EX-99.1

Exhibit 99.1

 

LOGO

Cara Therapeutics Reports First Quarter 2019 Financial Results

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

STAMFORD, Conn., May 7, 2019 – Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities with a primary focus on pruritus as well as pain by selectively targeting peripheral kappa opioid receptors, today announced financial results and operational highlights for the first quarter ended March 31, 2019.

“We are pleased with the progress made across our clinical pruritus programs in chronic kidney disease in the first quarter and remain on track to release top-line data from KALM-1, the first of our pivotal Phase 3 trials of KORSUVA Injection for chronic kidney disease-associated pruritus in hemodialysis patients, in the second quarter,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “Additionally, we look forward to broadening our clinical pruritus program for Oral KORSUVA with the initiation of Phase 2 trials in chronic liver disease and atopic dermatitis in the next few months.”

First Quarter and Recent Developments:

KORSUVA (CR845/difelikefalin) Injection Phase 3 Program: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis

In January 2019, based on the recommendation of the Independent Data Monitoring Committee, the Company announced that its pivotal KALM™-1 Phase 3 trial of KORSUVA Injection will continue as planned with no changes to the original enrollment target of 350 hemodialysis patients with moderate-to-severe CKD-aP. The pre-specified interim conditional power assessment was conducted after approximately half of the targeted number of patients completed the designated 12-week treatment period. The Company also announced the completion of enrollment in the KALM-1 trial, and it expects top-line data from this trial in the second quarter of 2019.

The Company continues to enroll patients in the United States, Europe and Asia Pacific in KALM-2, the global Phase 3 efficacy trial of KORSUVA Injection. Based on current patient enrollment projections, the Company expects top-line data from this trial in the second half of 2019.


The Company’s long term, 52-week open-label Phase 3 safety trial continues to progress. Approximately 150 patients have completed at least 6 months of treatment and approximately 40% of these patients have completed 1 year of treatment.

In the second quarter of 2019, the Company initiated an additional open-label safety trial of KORSUVA Injection that is expected to enroll up to 400 hemodialysis patients with CKD-aP for up to 12 weeks of treatment. Both of the safety trials are expected to support worldwide registration filings of KORSUVA Injection.

Oral KORSUVA: CKD-aP: Non-Hemodialysis

The Company continues to enroll patients in the Phase 2 trial of Oral KORSUVA for the treatment of pruritus in stage III – V (moderate-to-severe) chronic kidney disease, or CKD, patients. Based on current enrollment projections, the Company anticipates top-line data from this trial in the second half of 2019.

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

The Company recently completed a Phase 1 trial of Oral KORSUVA at multiple tablet strengths in patients with chronic liver disease, or CLD. The pharmacokinetic parameters were dose proportional and Oral KORSUVA was generally well tolerated with no unexpected safety signals reported. The Company expects to initiate a Phase 2 trial in CLD patients with moderate-to-severe pruritus in the second quarter of 2019.

Oral KORSUVA: Atopic Dermatitis

The Company plans to initiate a multi-dose, proof-of-concept Phase 2 trial of Oral KORSUVA in atopic dermatitis patients with moderate-to-severe pruritus around mid-year 2019.

Upcoming Activities

The Company expects to make presentations at the following conferences:

 

   

Bank of America Merrill Lynch Health Care Conference 2019, May 14-16, 2019

 

   

Jefferies 2019 Healthcare Conference, June 4-7, 2019

 

   

European Academy of Dermatology and Venereology, October 9–13, 2019

First Quarter 2019 Financial Results

Net Loss: The Company reported a net loss of $22.0 million, or $0.56 per basic and diluted share, for the first quarter of 2019 compared to a net loss of $16.8 million, or $0.51 per basic and diluted share, for the first quarter of 2018.

 

2


Revenues: Total revenue was $4.4 million for the three months ended March 31, 2019. There was no revenue during the three months ended March 31, 2018. Total revenue in 2019 consisted of:

 

  (1)

License and milestone fees revenue of $4.2 million that was recognized by the Company related to its license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd.

 

  (2)

Clinical compound revenue of $140,000 that was earned by the Company from the sale of clinical compound to Maruishi Pharmaceutical Co. Ltd.

Research and Development (R&D) Expenses: R&D expenses were $23.6 million for the three months ended March 31, 2019 compared to $13.4 million for the three months ended March 31, 2018. The higher R&D expenses in 2019 were primarily due to a net increase in clinical trial costs, as well as increases in stock compensation expense and payroll and related costs.

General and Administrative (G&A) Expenses: G&A expenses were $3.9 million for the three months ended March 31, 2019 compared to $3.7 million for the three months ended March 31, 2018. The increase in 2019 was primarily due to increases in legal, accounting and consultants’ costs.

Other Income: Other income was $1.1 million for the three months ended March 31, 2019 compared to $311,000 for the three months ended March 31, 2018. The increase in 2019 was due to an increase in interest and accretion income resulting from a higher average balance of the Company’s portfolio of investments in the 2019 period.

Cash and Cash Equivalents and Marketable Securities Position: At March 31, 2019, cash and cash equivalents and marketable securities totaled $156.1 million compared to $182.8 million at December 31, 2018. The decrease in the balance of cash and cash equivalents and marketable securities primarily resulted from cash used in operations of $27.5 million, partially offset by proceeds of $0.2 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, 2019 will be sufficient to fund its currently anticipated operating expenses and capital expenditures into the fourth quarter of 2020, 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 2019 financial results and provide a business update.

 

3


To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 3027399. A live webcast of the call can be accessed under “Events & 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 with a primary focus on pruritus as well as pain by selectively targeting peripheral kappa opioid receptors, or 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 pruritus-related quality of life measures in hemodialysis patients with moderate-to-severe CKD-aP and is currently being investigated in Phase 3 trials in hemodialysis patients with CKD-aP.

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 data readouts from the Company’s ongoing clinical trials, the expected timing for initiation 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, the potential for the Company’s product candidates to be alternatives in the therapeutic areas investigated, 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, 2018 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

 

4


CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS

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

(unaudited)

 

     Three Months Ended March 31,  
     2019     2018  

Revenue:

    

License and milestone fees

   $ 4,242     $ —    

Clinical compound revenue

     140       —    
  

 

 

   

 

 

 

Total revenue

     4,382       —    

Operating expenses:

    

Research and development

     23,608       13,427  

General and administrative

     3,908       3,697  
  

 

 

   

 

 

 

Total operating expenses

     27,516       17,124  
  

 

 

   

 

 

 

Operating loss

     (23,134     (17,124

Other income

     1,089       311  
  

 

 

   

 

 

 

Loss before benefit from income taxes

     (22,045     (16,813

Benefit from income taxes

     85       46  
  

 

 

   

 

 

 

Net loss

   $ (21,960   $ (16,767
  

 

 

   

 

 

 

Net loss per share :

    

Basic and Diluted

   $ (0.56   $ (0.51

Weighted average shares:

    

Basic and Diluted

     39,552,277       32,681,661  

 

5


CARA THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands)

(unaudited)

 

     March 31,
2019
    December 31,
2018
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 14,188     $ 15,081  

Marketable securities

     120,265       146,302  

Income tax receivable

     749       664  

Other receivables

     1,019       926  

Prepaid expenses

     7,577       4,805  

Restricted cash, current

     361       361  
  

 

 

   

 

 

 

Total current assets

     144,159       168,139  

Operating lease right-of-use asset

     3,492       —    

Marketable securities, non-current

     21,687       21,396  

Property and equipment, net

     841       880  

Restricted cash

     408       408  
  

 

 

   

 

 

 

Total assets

   $ 170,587     $ 190,823  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable and accrued expenses

   $ 13,310     $ 13,622  

Operating lease liability, current

     901       —    

Current portion of deferred revenue

     28,194       26,825  
  

 

 

   

 

 

 

Total current liabilities

     42,405       40,447  

Operating lease liability, non-current

     4,087       —    

Deferred revenue, non-current

     9,573       15,184  

Deferred lease obligation

     —         1,562  

Commitments and contingencies

     —         —    

Stockholders’ equity:

    

Preferred stock

     —         —    

Common stock

     39       39  

Additional paid-in capital

     430,724       428,059  

Accumulated deficit

     (316,314     (294,354

Accumulated other comprehensive income (loss)

     73       (114
  

 

 

   

 

 

 

Total stockholders’ equity

     114,522       133,630  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 170,587     $ 190,823  
  

 

 

   

 

 

 

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

 

6