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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) November 1, 2022

  

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 5.02Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangement of Certain Officers.

 

On November 1, 2022, the Board of Directors (the “Board”) of Cara Therapeutics, Inc. (the “Company”) appointed Lisa von Moltke, M.D. to serve as a member of the Board with a term expiring at the Company’s 2023 Annual Meeting of Stockholders. Dr. von Moltke was appointed to serve as a member of the nominating and corporate governance committee of the Board. There is no arrangement or understanding between Dr. von Moltke and any other person pursuant to which she was selected as a director, and there is no family relationship between Dr. von Moltke and any of the Company’s other directors or executive officers.

 

Dr. von Moltke, age 63, currently serves as Executive Vice President and Chief Medical Officer at Seres Therapeutics, Inc. (“Seres”), a position she has held since April 2020. Prior to joining Seres, Dr. von Moltke served in roles of increasing seniority at Alkermes, Inc. from June 2015 to December 2019, culminating as Senior Vice President and Head of Clinical Development. Dr. von Moltke has served as President of the American College of Clinical Pharmacology and Editor-in-Chief of The Journal of Clinical Pharmacology. She received a B.A. from Wellesley College and M.D. from Michigan State University, College of Human Medicine.

 

In accordance with the Company’s non-employee director compensation policy, Dr. von Moltke will receive an annual cash retainer of $45,000 for her service as a director, an annual cash retainer of $5,000 for her service on the nominating and corporate governance committee and, on January 2, 2023, an initial stock option grant with a Black-Scholes value of $350,000. This option will vest over a period of three years, in twelve equal quarterly installments, from the date of Dr. von Moltke’s appointment to the Board.

 

The Company expects to enter into its standard indemnification agreement for directors with Dr. von Moltke, the form of which was previously filed by the Company as Exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No. 333-192230), filed with the Securities and Exchange Commission on January 17, 2014.

 

Item 7.01Regulation FD Disclosure.

 

On November 3, 2022, the Company issued a press release announcing the appointment of Dr. von Moltke to the Board. A copy of the press release is being furnished to the SEC as Exhibit 99.1 to this Form 8-K and is incorporated by reference to this Item 7.01.

 

The information furnished pursuant to this Item 7.01, 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 SEC 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 9.01Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.    
99.1   Press Release dated November 3, 2022
104   Cover page interactive data file (formatted as Inline XBRL)

 

 

 

 

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/ CHRISTOPHER POSNER
    Christopher Posner
    Chief Executive Officer

 

Date: November 3, 2022

 

 

 

 

Exhibit 99.1

 

 

 

Cara Therapeutics Announces Appointment of Lisa von Moltke, M.D., to its Board of Directors

 

STAMFORD, Conn., November 3, 2022 – Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the appointment of Lisa von Moltke, M.D., to its Board of Directors. Dr. von Moltke currently serves as Executive Vice President and Chief Medical Officer at Seres Therapeutics, Inc.

 

“We are very pleased to welcome Lisa to our board of directors,” said Christopher Posner, President, Chief Executive Officer and Director of Cara Therapeutics. “Her extensive clinical development and pharmacology expertise will be of great value as we continue executing our strategy to expand the utility and maximize the potential of oral difelikefalin for the treatment of pruritus.”

 

“It’s an exciting time to be joining the board of Cara Therapeutics,” said Dr. von Moltke. “I look forward to working with the Cara team as its late-stage oral difelikefalin pipeline progresses in multiple therapeutic indications for the treatment of pruritus, an underserved and burdensome condition.”

 

Dr. von Moltke has directed successful development programs, led clinical teams, and interacted with regulatory agencies across multiple therapeutic areas. Prior to joining Seres, Dr. von Moltke served in roles of increasing seniority at Alkermes, Inc., culminating as Senior Vice President and Head of Clinical Development. Previously, Dr. von Moltke was Vice President Clinical Pharmacology at Sanofi/Genzyme Corporation, where she also served as U.S. Head Clinical & Exploratory Pharmacology Sciences (CEP) and Early Development and later as Head CEP for Japan and China regions. Earlier in her career, she was Head, Translational Medicine for the Takeda Oncology Company. Dr. von Moltke has served as President of the American College of Clinical Pharmacology and Editor-in-Chief of The Journal of Clinical Pharmacology. She received a B.A. from Wellesley College and M.D. from Michigan State University, College of Human Medicine.

 

About Cara Therapeutics

 

Cara Therapeutics is a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company’s novel KORSUVA® (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The Company is developing an oral formulation of difelikefalin and has initiated Phase 3 programs for the treatment of pruritus in patients with non-dialysis dependent advanced chronic kidney disease and atopic dermatitis. The Company has completed a Phase 2 proof-of-concept trial of oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica. A Phase 2 proof-of-concept trial in primary biliary cholangitis patients with moderate-to-severe pruritus is ongoing. For more information, visit www.CaraTherapeutics.com and follow the company on Twitter, LinkedIn and Instagram.

 

 

 

 

 

 

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 Company’s future development of oral difelikefalin for treatment of pruritus. 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 the Company’s 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, 2021, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2022. 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, except as required by law.

 

MEDIA CONTACT:

Annie Spinetta

6 Degrees

973-768-2170

aspinetta@6degreespr.com

 

INVESTOR CONTACT:

Iris Francesconi, Ph.D.

Cara Therapeutics

203-406-3700

investor@caratherapeutics.com