New Enterprise Associates 16 SC 13D Trevi Therapeutics, Inc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

SCHEDULE 13D

Under the Securities Exchange Act of 1934

(Amendment No. ___)*

Trevi Therapeutics, Inc.

(Name of Issuer)

Common Stock, $0.001 par value

(Title of Class of Securities)

89532M101

(CUSIP Number)

Louis S. Citron, Esq.

New Enterprise Associates

1954 Greenspring Drive, Suite 600, Timonium, MD  21093

(410) 842-4000

(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications)

May 9, 2019

(Date of Event which Requires Filing of this Statement)

If the filing person has previously filed a statement on Schedule 13G to report the acquisition that is the subject of this Schedule 13D, and is filing this schedule because of §§240.13d-1(e), 240.13d-1(f) or 240.13d-1(g), check the following box.  ☐

Note:  Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits.  See §240.13d-7 for other parties to whom copies are to be sent.

*The remainder of this cover page shall be filled out for a reporting person's initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page.

The information required on the remainder of this cover page shall not be deemed to be "filed" for the purpose of Section 18 of the Securities Exchange Act of 1934 ("Act") or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).

CUSIP No.     89532M101 13D Page 2 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	New Enterprise Associates 16, L.P.
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	WC
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	Delaware Limited Partnership
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	PN

CUSIP No.     89532M101 13D Page 3 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	NEA Partners 16, L.P.
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	Delaware Limited Partnership
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	PN

CUSIP No.     89532M101 13D Page 4 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	NEA 16 GP, LLC
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	Delaware Limited Liability Company
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	OO

CUSIP No.     89532M101 13D Page 5 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Peter J. Barris
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 6 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Forest Baskett
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 7 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Ali Behbahani
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 8 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Carmen Chang
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 9 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Anthony A. Florence, Jr.
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 10 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Mohamad H. Makhzoumi
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 11 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Joshua Makower
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 12 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	David M. Mott
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 13 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Scott D. Sandell
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 14 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Peter W. Sonsini
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 15 of 24 Pages    

1	NAMES OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	Paul Walker
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP			(a)	☐
				(b)	☐
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	AF
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United States citizen
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			0 shares
		8	SHARED VOTING POWER
			4,438,562 shares
		9	SOLE DISPOSITIVE POWER
			0 shares
		10	SHARED DISPOSITIVE POWER
			4,438,562 shares
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,438,562 shares
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	25.0%
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	IN

CUSIP No.     89532M101 13D Page 16 of 24 Pages    

Schedule 13D

Item 1. Security and Issuer.

This statement relates to the common shares, $0.001 par value (the "Common Stock"), of Trevi Therapeutics, Inc. (the "Issuer") having its principal executive office at 195 Church Street, 14^th Floor, New Haven, Connecticut.

Item 2. Identity and Background.

This statement is being filed by:

(a) New Enterprise Associates 16, L.P. ("NEA 16"), NEA Partners 16, L.P. ("NEA Partners 16"), which is the sole general partner of NEA 16; and NEA 16 GP, LLC ("NEA 16 LLC" and, together with NEA Partners 16, the "Control Entities"), which is the sole general partner of NEA Partners 16; and

(b) Peter J. Barris ("Barris"), Forest Baskett ("Baskett"), Ali Behbahani ("Behbahani"), Carmen Chang ("Chang"), Anthony A. Florence, Jr. ("Florence"), Mohamad H. Makhzoumi ("Makhzoumi"), Joshua Makower ("Makower"), David M. Mott ("Mott"), Scott D. Sandell ("Sandell"), Peter W. Sonsini ("Sonsini") and Paul Walker ("Walker") (together, the "Managers").  The Managers are the managers of NEA 16 LLC.

The persons named in this Item 2 are referred to individually herein as a "Reporting Person" and collectively as the "Reporting Persons."

The address of the principal business office of NEA 16 and each Control Entity is New Enterprise Associates, 1954 Greenspring Drive, Suite 600, Timonium, MD 21093.  The address of the principal business office of each of Barris, Behbahani and Mott is New Enterprise Associates, 5425 Wisconsin Avenue, Suite 800, Chevy Chase, MD 20815.  The address of the principal business office of Baskett, Chang, Makhzoumi, Makower, Sandell, Sonsini and Walker is New Enterprise Associates, 2855 Sand Hill Road, Menlo Park, California 94025. The address of the principal business office of Florence is New Enterprise Associates, 104 5^th Avenue, 19^th Floor, New York, NY 10001.

The principal business of NEA 16 is to invest in and assist growth-oriented businesses located principally in the United States.  The principal business of NEA Partners 16 is to act as the sole general partner of NEA 16.  The principal business of NEA 16 LLC is to act as the sole general partner of NEA Partners 16.  The principal business of each of the Managers is to manage the Control Entities, NEA 16 and a number of affiliated partnerships with similar businesses.

During the five years prior to the date hereof, none of the Reporting Persons has been convicted in a criminal proceeding or has been a party to a civil proceeding ending in a judgment, decree or final order enjoining future violations of, or prohibiting or mandating activities subject to, federal or state securities laws or finding any violation with respect to such laws.

NEA 16 LLC is a limited liability company organized under the laws of the State of Delaware.  NEA 16 and NEA Partners 16 are limited partnerships organized under the laws of the State of Delaware. Each of the Managers is a United States citizen.

Item 3. Source and Amount of Funds or Other Consideration.

On April 5, 2019, the Registration Statement on Form S-1 filed with the Securities and Exchange Commission ("SEC") by the Issuer (File No. 333-230745) in connection with its initial public offering of 5,500,000 shares of Common Stock of the Issuer (the "IPO") was declared effective.  The closing of the IPO took place on May 9, 2019 and at such closing NEA 16 purchased an aggregate of 1,000,000 shares of Common Stock at the IPO price of $10.00 per share from the Issuer.  Concurrently with the IPO, NEA 16 purchased 1,500,000 shares of Common Stock at the IPO price of $10.00 per share from the Issuer in a private placement transaction (the "NEA 16 Private Placement Shares").  In addition, prior to the IPO, NEA 16 held Series C Preferred Stock that converted on a 9.5-for-one basis into 1,938,562 shares of the Issuer's Common Stock (the "NEA 16 Common Converted Shares" and, together with the NEA 16 Private Placement Shares, the "NEA 16 Lock-up Shares").  NEA 16 now holds a total of 4,438,562 shares of Common Stock.

The working capital of NEA 16 was the source of the funds for the purchase of the NEA 16 Shares.  No part of the purchase price of the NEA 16 Shares was represented by funds or other consideration borrowed or otherwise obtained for the purpose of acquiring, holding, trading or voting the NEA 16 Shares.

CUSIP No.     89532M101 13D Page 17 of 24 Pages    

Item 4. Purpose of Transaction.

NEA 16 acquired the NEA 16 Shares for investment purposes.  Depending on market conditions, its continuing evaluation of the business and prospects of the Issuer and other factors, NEA 16 and other Reporting Persons may dispose of or acquire additional shares of the Issuer.  Except as set forth above, none of the Reporting Persons has any present plans which relate to or would result in:

(a) The acquisition by any person of additional securities of the Issuer, or the disposition of securities of the Issuer;

(b) An extraordinary corporate transaction, such as a merger, reorganization or liquidation, involving the Issuer or any of its subsidiaries;

(c) A sale or transfer of a material amount of assets of the Issuer or any of its subsidiaries;

(d) Any change in the present board of directors or management of the Issuer, including any plans or proposals to change the number or term of directors or to fill any existing vacancies on the board;

(e) Any material change in the present capitalization or dividend policy of the Issuer;

(f) Any other material change in the Issuer's business or corporate structure;

(g) Changes in the Issuer's charter, bylaws or instruments corresponding thereto or other actions which may impede the acquisition of control of the Issuer by any person;

(h) Causing a class of securities of the Issuer to be delisted from a national securities exchange or to cease to be authorized to be quoted in an inter-dealer quotation system of a registered national securities association;

(i) A class of equity securities of the Issuer becoming eligible for termination of registration pursuant to Section 12(g)(4) of the Securities Exchange Act of 1934; or

(j) Any action similar to any of those enumerated above.

Item 5. Interest in Securities of the Issuer.

NEA 16 is the record owner of the NEA 16 Shares.  As the general partner of NEA 16, NEA Partners 16 may be deemed to own beneficially the NEA 16 Shares.  As the sole general partner of NEA Partners 16, NEA 16 LLC may be deemed to own beneficially the NEA 16 Shares.  As members of NEA 16 LLC, each of the Managers may be deemed to own beneficially the NEA 16 Shares.

 

CUSIP No.     89532M101 13D Page 18 of 24 Pages    

Each Reporting Person disclaims beneficial ownership of the NEA 16 Shares other than those shares which such person owns of record.

The percentage of outstanding Common Stock of the Issuer which may be deemed to be beneficially owned by each Reporting Person is set forth on Line 13 of such Reporting Person's cover sheet.  Such percentage was calculated based on 17,771,751 shares of Common Stock reported to be outstanding immediately after the IPO on the Issuer's prospectus filed under Rule 424(b)(4), filed with the SEC on May 8, 2019.

 (b) Regarding the number of shares as to which such person has:

(i) sole power to vote or to direct the vote: See line 7 of cover sheets

(ii) shared power to vote or to direct the vote: See line 8 of cover sheets

(iii) sole power to dispose or to direct the disposition: See line 9 of cover sheets

(iv) shared power to dispose or to direct the disposition: See line 10 of cover sheets

(c) Except as set forth in Item 3 above, none of the Reporting Persons has effected any transaction in the Common Stock during the last 60 days.

(d) No other person is known to have the right to receive or the power to direct the receipt of dividends from, or any proceeds from the sale of, Common Stock beneficially owned by any of the Reporting Persons.

(e) Not applicable.

Item 6. Contracts, Arrangements, Undertakings or Relationships with Respect to Securities of the Issuer.

NEA 16 has agreed into a lock-up agreement pursuant to which NEA 16 has agreed, subject to limited exceptions, not to offer, pledge, sell or contract to sell any NEA 16 Lock-up Shares, sell any option or contract to purchase any NEA 16 Lock-up Shares, purchase any option or contract to sell any NEA 16 Lock-up Shares; grant any option, right or warrant for the sale of any NEA 16 Lock-up Shares; otherwise dispose of or transfer any NEA 16 Lock-up Shares; exercise any right with respect to the registration of any NEA 16 Lock-up Shares; or file or cause to be filed a registration statement in connection therewith, or enter into any swap or other agreement or any transaction that transfers, in whole or in part, the economic consequence of ownership of any NEA 16 Lock-up Shares, whether any such swap, agreement or transaction is to be settled by delivery of shares or other securities, in cash or otherwise, for a period of 180 days after May 7, 2019, without the prior written consent of SVB Leerink LLC.

Item 7. Material to be Filed as Exhibits.

Exhibit 1 – Agreement regarding filing of joint Schedule 13D.

Exhibit 2 – Power of Attorney regarding filings under the Securities Exchange Act of 1934, as amended.

CUSIP No.     89532M101 13D Page 19 of 24 Pages    

SIGNATURE

After reasonable inquiry and to the best of its knowledge and belief, each of the undersigned certifies that the information set forth in this statement is true, complete and correct.

EXECUTED this 20^th day of May, 2019.

NEW ENTERPRISE ASSOCIATES 16, L.P.

By: NEA PARTNERS 16, L.P.General Partner

By: NEA 16 GP, LLCGeneral Partner

By:                 *                                     

 Scott D. Sandell

 Chief Executive Officer

NEA PARTNERS 16, L.P.

By: NEA 16 GP, LLCGeneral Partner

By:                             *                            

        Scott D. Sandell

        Chief Executive Officer

NEA 16 GP, LLC

By:                             *                            

        Scott D. Sandell

        Chief Executive Officer

                          *                                     

Peter J. Barris

                          *                                     

Forest Baskett

CUSIP No.     89532M101 13D Page 20 of 24 Pages    

                          *                                     

Ali Behbahani

                          *                                     

Carmen Chang

                          *                                     

Anthony A. Florence, Jr.

                          *                                     

Mohamad H. Makhzoumi

                          *                                     

Joshua Makower

                          *                                     

David M. Mott

                          *                                     

Scott D. Sandell

                          *                                     

Peter W. Sonsini

                          *                                     

Paul Walker

*/s/ Sasha O. Keough               

Sasha O. Keough

As attorney-in-fact

This Schedule 13D was executed by Sasha O. Keough on behalf of the individuals listed above pursuant to a Power of Attorney a copy of which is attached as Exhibit 2.

CUSIP No.     89532M101 13D Page 21 of 24 Pages    

EXHIBIT 1

AGREEMENT

Pursuant to Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, the undersigned hereby agree that only one statement containing the information required by Schedule 13D need be filed with respect to the ownership by each of the undersigned of shares of stock of Trevi Therapeutics, Inc.

EXECUTED this 20^th day of May, 2019.

NEW ENTERPRISE ASSOCIATES 16, L.P.

By: NEA PARTNERS 16, L.P.General Partner

By: NEA 16 GP, LLCGeneral Partner

By:                 *                                     

 Scott D. Sandell

 Chief Executive Officer

NEA PARTNERS 16, L.P.

By: NEA 16 GP, LLCGeneral Partner

By:                             *                ��           

        Scott D. Sandell

        Chief Executive Officer

NEA 16 GP, LLC

By:                             *                            

        Scott D. Sandell

        Chief Executive Officer

                          *                                     

Peter J. Barris

                          *                                     

Forest Baskett

CUSIP No.     89532M101 13D Page 22 of 24 Pages    

                          *                                     

Ali Behbahani

                          *                                     

Carmen Chang

                          *                                     

Anthony A. Florence, Jr.

                          *                                     

Mohamad H. Makhzoumi

                          *                                     

Joshua Makower

                          *                                     

David M. Mott

                          *                                     

Scott D. Sandell

                          *                                     

Peter W. Sonsini

                          *                                     

Paul Walker

*/s/ Sasha O. Keough               

Sasha O. Keough

As attorney-in-fact

This Agreement relating to Schedule 13D was executed by Sasha O. Keough on behalf of the individuals listed above pursuant to a Power of Attorney a copy of which is attached hereto as Exhibit 2.

CUSIP No.     89532M101 13D Page 23 of 24 Pages    

EXHIBIT 2

POWER OF ATTORNEY

KNOW ALL MEN BY THESE PRESENTS, that the undersigned hereby constitutes and appoints Louis S. Citron, Timothy Schaller, Sasha Keough and Stephanie Brecher, and each of them, with full power to act without the others, his or her true and lawful attorney-in-fact, with full power of substitution, to sign any and all instruments, certificates and documents that may be necessary, desirable or appropriate to be executed on behalf of himself as an individual or in his or her capacity as a direct or indirect general partner, director, officer or manager of any partnership, corporation or limited liability company, pursuant to section 13 or 16 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and any and all regulations promulgated thereunder, and to file the same, with all exhibits thereto, and any other documents in connection therewith, with the Securities and Exchange Commission, and with any other entity when and if such is mandated by the Exchange Act or by the Financial Industry Regulatory Authority, granting unto said attorney-in-fact full power and authority to do and perform each and every act and thing necessary, desirable or appropriate, fully to all intents and purposes as he or she might or could do in person, thereby ratifying and confirming all that said attorney-in-fact, or his or her substitutes, may lawfully do or cause to be done by virtue hereof.

IN WITNESS WHEREOF, this Power of Attorney has been signed as of the 13th day of March, 2017.

/s/ M. James Barrett                                

M. James Barrett

/s/ Peter J. Barris                                      

Peter J. Barris

/s/ Forest Baskett                                    

Forest Baskett

/s/ Ali Behbahani                                     

Ali Behbahani

/s/ Colin Bryant                                       

Colin Bryant

/s/ Carmen Chang                                    

Carmen Chang

/s/ Anthony A. Florence, Jr.                  

Anthony A. Florence, Jr.

/s/ Carol G. Gallagher                              

Carol G. Gallagher

/s/ Dayna Grayson                                  

Dayna Grayson

/s/ Patrick J. Kerins                                  

Patrick J. Kerins

CUSIP No.     89532M101 13D Page 24 of 24 Pages    

/s/ P. Justin Klein                                     

P. Justin Klein

/s/ Vanessa Larco                                    

Vanessa Larco

/s/ Joshua Makower                                

Joshua Makower

/s/ Mohamad H. Makhzoumi                 

Mohamad H. Makhzoumi

/s/ Edward T. Mathers                            

Edward T. Mathers

/s/ David M. Mott                                   

David M. Mott

/s/ Sara M. Nayeem                                 

Sara M. Nayeem

/s/ Jason R. Nunn                                    

Jason R. Nunn

/s/ Gregory Papadopoulos                     

Gregory Papadopoulos

/s/ Chetan Puttagunta                             

Chetan Puttagunta

/s/ Jon Sakoda                                         

Jon Sakoda

/s/ Scott D. Sandell                                 

Scott D. Sandell

/s/ A. Brooke Seawell                              

A. Brooke Seawell

/s/ Peter W. Sonsini                                

Peter W. Sonsini

/s/ Melissa Taunton                               

Melissa Taunton

/s/ Frank M. Torti                                    

Frank M. Torti

/s/ Ravi Viswanathan                              

Ravi Viswanathan

/s/ Paul E. Walker                                    

Paul E. Walker

/s/ Rick Yang                                            

Rick Yang