0001104659-21-043535.txt : 20210330 0001104659-21-043535.hdr.sgml : 20210330 20210330060155 ACCESSION NUMBER: 0001104659-21-043535 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20210330 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210330 DATE AS OF CHANGE: 20210330 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cara Therapeutics, Inc. CENTRAL INDEX KEY: 0001346830 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36279 FILM NUMBER: 21783501 BUSINESS ADDRESS: STREET 1: 4 STAMFORD PLAZA STREET 2: 107 ELM STREET 9TH FLOOR CITY: STAMFORD STATE: CT ZIP: 06902 BUSINESS PHONE: 203-406-3700 MAIL ADDRESS: STREET 1: 4 STAMFORD PLAZA STREET 2: 107 ELM STREET 9TH FLOOR CITY: STAMFORD STATE: CT ZIP: 06902 FORMER COMPANY: FORMER CONFORMED NAME: Cara Therapeutics Inc DATE OF NAME CHANGE: 20051213 8-K 1 tm218984d2_8k.htm FORM 8-K
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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) March 30, 2021

 

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))

 

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

 

Title of each class Trading Symbol Name of each exchange on which registered
Common Stock, par value $0.001 per share CARA The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant 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 7.01. Results of Operations and Financial Condition.

 

On March 30, 2021, Cara Therapeutics, Inc. (the “Company”) and Vifor Fresenius Medical Care Renal Pharma jointly issued a press release announcing that the European Medicines Agency has accepted to review the Marketing Authorization Application for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients.

 

The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d)

Exhibits 

 

Exhibit No. Description
99.1 Press Release dated March 30, 2021
104 Cover page interactive data file (formatted as Inline XBRL)

 

2

 

 

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/ THOMAS REILLY
    Thomas Reilly
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

Date: March 30, 2021

 

3

 

 EX-99.1 2 tm218984d2_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

Press
Release

 

VFMCRP and Cara Therapeutics announce European Medicines Agency has accepted to review the Marketing Authorization Application for difelikefalin

 

  · Companies have successfully submitted the EU regulatory application for marketing authorization for difelikefalin

  · If approved, difelikefalin injection will be the first therapy available in Europe for treatment of pruritus associated with chronic kidney disease in hemodialysis patients

 

St.Gallen, Switzerland, and Stamford, Conn., 30 March 2021 – Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients. The EMA will review the application under the centralized marketing authorization procedure.

 

The EMA filing is supported by positive clinical data from the two pivotal phase-III trials KALM-1 and KALM-2, as well as supportive data from an additional 32 clinical studies. If approved, difelikefalin would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. EMA’s decision on the EU MAA is expected Q2-2022.

 

“Following the US FDA’s acceptance and priority review for the New Drug Application for difelikefalin at the beginning of March 2021, this is another major step forward on our mission to help kidney patients around the world lead better, healthier lives,” commented Stefan Schulze, CEO of Vifor Pharma Group. “Together with our partner Cara Therapeutics, we remain focused on making this innovative therapy available in Europe, if approved, for patients with chronic kidney disease-associated pruritus, a condition that has been historically underdiagnosed and undertreated.”

 

“The acceptance of the EU regulatory application for difelikefalin marks another major milestone towards our goal of bringing this first-in-class therapeutic to the significant number of hemodialysis patients worldwide with chronic intractable pruritus,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We look forward to working closely with our partner, Vifor Pharma, through the EMA review process and in preparation for commercial launch across European territories, if approved.”

 

Contact and further information:
 

Media Relations

Nathalie Ponnier

Global Head Corporate Communications

+41 79 957 96 73

media@viforpharma.com

Investor Relations

Julien Vignot

Head of Investor Relations

+41 58 851 66 90

investors@viforpharma.com

  

 

Vifor Pharma Group Phone +41 58 851 8000
Flughofstrasse 61 E-mail info@viforpharma.com
8152 Glattbrugg Web viforpharma.com
Switzerland    

 

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Cara Therapeutics contacts:

 

Media Contact  Investor Contact
Claire LaCagnina  Janhavi Mohite
6 Degrees  Stern Investor Relations,Inc.
315-765-1462  212-363-1200
clacagnina@6degreespr.com  janhavi.mohite@sternir.com

 

About Vifor Pharma Group

 

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

 

For more information, please visit viforpharma.com.

 

About Cara Therapeutics

 

Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body’s peripheral nervous system, as well as certain immune cells. In two Phase 3 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). Oral KORSUVA™ has successfully completed a Phase 2 trial for the treatment of pruritus in patients with CKD and is currently in Phase 2 trials in atopic dermatitis, primary biliary cholangitis and notalgia paresthetica patients with moderate-to-severe pruritus.

 

About Chronic Kidney Disease-associated Pruritus (CKD-aP)

 

CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis.  The majority of dialysis patients (approximately 60 to 70%) report pruritus, with 30 to 40% reporting moderate or severe pruritus.1,2,3 Recent data from the ITCH National Registry Study showed that among those with pruritus, approximately 59% experienced symptoms daily or nearly daily for more than a year. Given its association with CKD/ESRD, most afflicted patients will continue to have symptoms for months or years, with currently employed antipruritic treatments, such as antihistamines and corticosteroids, unable to provide consistent, adequate relief. Moderate-to-severe chronic pruritus has repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life (such as poor sleep quality), and is associated with depression.4 CKD-aP is also an independent predictor of mortality and the risk for hospitalization among hemodialysis patients.

 

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 potential regulatory approval of difelikefalin solution for injection and the potential timeline for EMA review and approval of the MAA and the potential of difelikefalin solution for injection to be a therapeutic option for CKD-aP in dialysis dependent patients. 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's filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara's Annual Report on Form 10-K for the year ended 31 December 2020 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. Except to the extent required by law, Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

References:

 

1Pisoni RL, et al. Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant. 2006; 21:3495-3505.
2Ramakrishnan K, et al. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms. International Journal of Nephrology and Renovascular Disease. 2014; 7: 1-12.
3Sukul et al. Self-reported Pruritus and Clinical, Dialysis-Related, and Patient-Reported Outcomes in Hemodialysis Patients. Kidney Med. 2020 Nov 21;3(1):42-53.
4Mathur VS, et al. A longitudinal study of Uremic Pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010; 5(8):1410-1419.

 

Vifor Pharma Group Phone +41 58 851 8000
Flughofstrasse 61 E-mail info@viforpharma.com
8152 Glattbrugg Web viforpharma.com
Switzerland    

 

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Cover
Mar. 30, 2021
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Mar. 30, 2021
Entity File Number 001-36279
Entity Registrant Name CARA THERAPEUTICS, INC.
Entity Central Index Key 0001346830
Entity Tax Identification Number 75-3175693
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 4 Stamford Plaza
Entity Address, Address Line Two 107 Elm Street
Entity Address, Address Line Three 9th Floor
Entity Address, City or Town Stamford
Entity Address, State or Province CT
Entity Address, Postal Zip Code 06902
City Area Code 203
Local Phone Number 406-3700
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol CARA
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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