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): February 13, 2020

 

 

Trevi Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   001-38886   45-0834299

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

195 Church Street, 14th Floor

New Haven, Connecticut

  06510
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (203) 304-2499

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

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. below):

 

☐

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(s)

 

Name of each exchange

on which registered

Common stock, $0.001 par value per share   TRVI   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 5.02

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On February 13, 2020, the Board of Directors (the “Board”) of Trevi Therapeutics, Inc., a Delaware corporation (the “Company”), elected James V. Cassella, Ph.D. to the Board as a Class I Director, effective immediately, with a term expiring at the 2020 annual meeting of stockholders.

Dr. Cassella has served as Chief Development Officer for Concert Pharmaceuticals, Inc. (“Concert”), a publicly-traded biotechnology company, since February 2015. Prior to joining Concert, Dr. Cassella served as Executive Vice President, Research and Development and Chief Scientific Officer of Alexza Pharmaceuticals, Inc. from July 2012 to January 2015 and served as its Senior Vice President, Research and Development from June 2004 to July 2012. From April 1989 to April 2004, Dr. Cassella held various management positions at Neurogen Corporation (“Neurogen”), a publicly traded biotechnology company. Prior to Neurogen, Dr. Cassella was Assistant Professor of Neuroscience at Oberlin College. Dr. Cassella received a Ph.D. in Physiological Psychology from Dartmouth College, completed a postdoctoral fellowship in the Department of Psychiatry at the Yale University School of Medicine and received a B.A. in Psychology from the University of New Haven.

There are no arrangements or understandings between Dr. Cassella and any other person pursuant to which he was elected as a director of the Company.

In accordance with the Company’s director compensation program, Dr. Cassella will receive an annual cash retainer of $35,000 for service on the Board which is payable quarterly in arrears. In addition, under the Company’s director compensation program, upon his election as a director, Dr. Cassella was granted an option on February 13, 2020 to purchase 23,684 shares of the Company’s common stock at an exercise price per share of $5.50. This option vests as to 50% of the shares on the earlier of the first anniversary of the date of grant or the date of the first annual meeting of stockholders held following the date of grant with the remainder vesting on the earlier of the second anniversary of the date of grant or the date of the second annual meeting of stockholders held following the date of grant, and becomes exercisable in full upon the occurrence of a change in control of the Company. For a full description of the Company’s director compensation program, see Exhibit 10.7 to the Company’s Registration Statement on Form S-1 (File No. 333-230745) filed with the Securities and Exchange Commission (the “SEC”) on April 5, 2019.

Also in connection with Dr. Cassella’s election to the Board, Dr. Cassella will enter into the Company’s standard form of indemnification agreement, a copy of which was filed as Exhibit 10.12 to the Company’s Registration Statement on Form S-1 (File No. 333-230745) filed with the SEC on April 5, 2019. Pursuant to the terms of this agreement, the Company may be required, among other things, to indemnify Dr. Cassella for some expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by him in any action or proceeding arising out of his service as one of the Company’s directors.

A copy of the Company’s press release announcing Dr. Cassella’s election is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits:

 

Exhibit
No. 		  

Description

99.1    Press Release dated February 18, 2020*

 

*

The information contained in Exhibit 99.1 attached hereto relating to Item 5.02 shall be deemed to be furnished, and not filed.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    TREVI THERAPEUTICS, INC.

Date: February 18, 2020

   

By:

 

/s/ Jennifer L. Good

     

Name: Jennifer L. Good

     

Title: President and Chief Executive Officer

Exhibit 99.1

LOGO

Trevi Therapeutics Announces Election of James V. Cassella, Ph.D. to

Board of Directors

Seasoned biopharmaceutical executive with over 30 years of

drug development experience

New Haven, Conn., February 18, 2020 – Trevi Therapeutics, Inc. (“Trevi”), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced the election of James V. Cassella, Ph.D. to Trevi’s Board of Directors.

Dr. Cassella joins Trevi’s Board with over 30 years of drug development experience working with emerging growth biopharmaceutical companies. He has served as Chief Development Officer of Concert Pharmaceuticals since 2015, and prior to that held senior executive and leadership roles with Alexza Pharmaceuticals, Inc. and Neurogen Corporation. Before joining the biopharmaceutical industry, Dr. Cassella was Assistant Professor of Neurosciences at Oberlin College. Dr. Cassella received his Ph.D. in Physiological Psychology from Dartmouth College, completed a postdoctoral fellowship in the Department of Psychiatry at the Yale University School of Medicine and received a B.A. in Psychology from the University of New Haven.

“Jim brings extensive scientific and clinical development experience which will be valuable assets for the Trevi Board as we execute against our business plans and strategy moving forward,” said Jennifer L. Good, President and Chief Executive Officer.

“I am very excited to join the Trevi Board and look forward to lending my extensive drug development experience and expertise to the Company’s already deep and knowledgeable Board and strong leadership team at such an exciting time for the Company,” said Dr. Cassella.

About Trevi Therapeutics, Inc.

Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa- induced dyskinesia (LID) in patients with Parkinson’s disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

About Nalbuphine ER

Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed k-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The k- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine’s mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe.

# # #

Investor Contact

Chris Seiter, Chief Financial Officer

Trevi Therapeutics, Inc.

203-304-2499

chris.seiter@trevitherapeutics.com

Media contact

Rosalia Scampoli

212-537-5177 ext. 7

rscampoli@marketcompr.com