UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
SCHEDULE 13G
 
Under the Securities Exchange Act of 1934
 
AVENUE THERAPEUTICS, INC.
(Name of Issuer)
 
Common Stock
(Title of Class of Securities)
 
05360L205
(CUSIP Number)
 
January 9, 2019
(Date of Event Which Requires Filing of this Statement)
 
Check the appropriate box to designate the rule pursuant to which this Schedule is filed:
 
 	[  ]	 Rule 13d-1(b)	
 	 	 	
 	[X]	 Rule 13d-1(c)	
 	 	 	
 	[  ]	 Rule 13d-1(d)	
 
* 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 the disclosures provided in a prior cover page.
 
The information required in 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. 05360L205	13G	Page 2 of 8 Pages	
 
 	NAMES OF REPORTING PERSONS	
 	Opaleye Management Inc.	
 	 	
1	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
20-5648796	
 	 	
 	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)	
 	 	
 	(a) [  ]	
2	(b) [  ]	
 	SEC USE ONLY	
 	 	
3	 	
 	CITIZENSHIP OR PLACE OF ORGANIZATION	
 	 	
4	Massachusetts	

NUMBER OF SHARES
BENEFICIALLY OWNED
BY EACH REPORTING
PERSON WITH:	 	SOLE VOTING POWER	
	 	 	
	5	0	
	 	SHARED VOTING POWER	
	 	 	
	6	550,000	
	 	SOLE DISPOSITIVE POWER	
	 	 	
	7	0	
	 	SHARED DISPOSITIVE POWER	
	 	 	
	8	550,000	

 	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON	
 	 	
9	550,000	
 	CHECK IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)	
 	 	
10	[  ]	
 	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)	
 	 	
11	5.16% *	
 	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)	
 	 	
12	CO	
 
* Based upon 10,662,398 shares of common stock issued and outstanding as reported by the Issuer on its Form 10-Q filed with the Securities and Exchange Commission on November 14, 2018. This calculation does not include the exercise or conversion of outstanding securities of the Company.

 
 
CUSIP No. 05360L205	13G	Page 3 of 8 Pages	
 
 	NAMES OF REPORTING PERSONS	
1	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
 
Opaleye, L.P.	
 	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)	
 	 	
 	(a) [  ]	
2	(b) [  ]	
 	SEC USE ONLY	
 	 	
3	 	
 	CITIZENSHIP OR PLACE OF ORGANIZATION	
 	 	
4	Delaware	

NUMBER OF SHARES
BENEFICIALLY OWNED
BY EACH REPORTING
PERSON WITH:	 	SOLE VOTING POWER	
	 	 	
	5	 0	
	 	SHARED VOTING POWER	
	 	 	
	6	550,000	
	 	SOLE DISPOSITIVE POWER	
	 	 	
	7	 0	
	 	SHARED DISPOSITIVE POWER	
	 	 	
	8	550,000	

 	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON	
 	 	
9	550,000	
 	CHECK IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)	
 	 	
10	[  ]	
 	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)	
 	 	
11	5.16% *	
 	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)	
 	 	
12	PN	
 
* Based upon 10,662,398 shares of common stock issued and outstanding as reported by the Issuer on its Form 10-Q filed with the Securities and Exchange Commission on November 14, 2018. This calculation does not include the exercise or conversion of outstanding securities of the Company.

 
 
CUSIP No. 05360L205	13G	Page 4 of 8 Pages	
 
 	NAMES OF REPORTING PERSONS	
1	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
 
James Silverman	
 	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)	
 	 	
 	(a) [  ]	
2	(b) [  ]	
 	SEC USE ONLY	
 	 	
3	 	
 	CITIZENSHIP OR PLACE OF ORGANIZATION	
 	 	
4	United States	

NUMBER OF SHARES
BENEFICIALLY OWNED
BY EACH REPORTING
PERSON WITH:	 	SOLE VOTING POWER	
	 	 	
	5	0	
	 	SHARED VOTING POWER	
	 	 	
	6	550,000	
	 	SOLE DISPOSITIVE POWER	
	 	 	
	7	0	
	 	SHARED DISPOSITIVE POWER	
	 	 	
	8	550,000	

 	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON	
 	 	
9	550,000	
 	CHECK IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)	
 	 	
10	[  ]	
 	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)	
 	 	
11	5.16% *	
 	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)	
 	 	
12	IN	
 
* Based upon 10,662,398 shares of common stock issued and outstanding as reported by the Issuer on its Form 10-Q filed with the Securities and Exchange Commission on November 14, 2018. This calculation does not include the exercise or conversion of outstanding securities of the Company.

 
 
CUSIP No. 05360L205	13G	Page 5 of 8 Pages	
 
Item 1(a).	Name of Issuer:	
 	 	
 	The name of the issuer is Avenue Therapeutics, Inc. (the “ Company ”).	
 	 	
Item 1(b).	Address of Issuer’s Principal Executive Offices:	
 	 	
 	The Company’s principal executive offices are located at 2 Gansevoort Street, 9th Floor, New York NY 10014.	
 	 	
Item 2(a).	Name of Person Filing.	
 	 	
 	This statement is filed by the entities and persons listed below, who are collectively referred to herein as “ Reporting Persons” with respect to the shares of common stock of the Company:	
 	 	
 	Opaleye Fund	
 	 	
 	Opaleye, L.P. (the “ Opaleye Fund ”), a private fund formed in the state of Delaware.	
 	 	
 	Investment Manager	
 	 	
 	Opaleye Management Inc. (the “ Investment Manager” ), with respect to the shares of common stock held by the Opaleye Fund, a private fund to which the Investment Manager serves as investment manager.	
 	 	
 	Reporting Individual	
 	 	
 	Mr. James Silverman (the “ Reporting Individual” ), with respect to the shares of common stock held by the Opaleye Fund. Mr. Silverman is the President of the Investment Manager.	
 	 	
Item 2(b).	Address of Principal Business Office or, if None, Residence.	
 	 	
 	One Boston Place, 26 th Floor	
 	Boston, Massachusetts 02108	
 	 	
Item 2(c).	Citizenship.	
 	 	
 	Citizenship is set forth in Row 4 of the cover page for each Reporting Person and is incorporated herein by reference for each such Reporting Person.	
 	 	
Item 2(d).	Title of Class of Securities.	
 	 	
 	Common Stock, $0.0001 par value	
 	 	
Item 2(e).	CUSIP Number.	
 	 	
 	05360L205	
 
Item 3. If This Statement is Filed Pursuant to Rule 13d-1(b), or 13d-2(b) or (c), Check Whether the Person Filing is a:
 
(a)	[  ]	Broker or dealer registered under Section 15 of the Exchange Act.	
 	 	 	
(b)	[  ]	Bank as defined in Section 3(a)(6) of the Exchange Act.	

 
 
CUSIP No. 05360L205	13G	Page 6 of 8 Pages	
 
(c)	[  ]	Insurance company as defined in Section 3(a)(19) of the Exchange Act.	
 	 	 	
(d)	[  ]	Investment company registered under Section 8 of the Investment Company Act.	
 	 	 	
(e)	[  ]	An investment adviser in accordance with Rule 13d-1(b)(1)(ii)(E);	
 	 	 	
(f)	[  ]	An employee benefit plan or endowment fund in accordance with Rule 13d-1(b)(1)(ii)(F);	
 	 	 	
(g)	[  ]	A parent holding company or control person in accordance with Rule 13d-1(b)(1)(ii)(G);	
 	 	 	
(h)	[  ]	A savings association as defined in Section 3(b) of the Federal Deposit Insurance Act;	
 	 	 	
(i)	[  ]	A church plan that is excluded from the definition of an investment company under Section 3(c)(14) of the Investment Company Act;	
 	 	 	
(j)	[  ]	A non-U.S. institution in accordance with Rule 13d-1(b)(1)(ii)(J);	
 	 	 	
(k)	[  ]	Group, in accordance with Rule 13d-1(b)(1)(ii)(K).	
 
If filing as a non-U.S. institution in accordance with Rule 13d-1(b)(1)(ii)(J), please specify the type of institution: _________________
 
Item 4. Ownership.
 
(a)	Amount beneficially owned:	
 	 	
 	Opaleye Management Inc. — 550,000 shares of common stock	
 	Opaleye, L.P. — 550,000 shares of common stock	
 	James Silverman — 550,000 shares of common stock	
 	 	
(b)	Percent of class:	
 	 	
 	Opaleye Management Inc. — 5.16%*	
 	Opaleye, L.P. — 5.16%*	
 	James Silverman — 5.16%*	
 
* Based upon 10,662,398 shares of common stock issued and outstanding as reported by the Issuer on its Form 10-Q filed with the Securities and Exchange Commission on November 14, 2018. This calculation does not include the exercise or conversion of outstanding securities of the Company.
 
(c)	Number of shares as to which the person has:	
 	 	 	
 	(i)	Sole power to vote or to direct the vote:	
 	 	 	
 	 	Opaleye Management Inc. — 0 shares	
 	 	Opaleye, L.P. — 0 shares	
 	 	James Silverman — 0 shares	

 
 
CUSIP No. 05360L205	13G	Page 7 of 8 Pages	
 
 	(ii)	Shared power to vote or to direct the vote:	
 	 	 	
 	 	Opaleye Management Inc. — 550,000 shares of common stock	
 	 	Opaleye, L.P. — 550,000 shares of common stock	
 	 	James Silverman — 550,000 shares of common stock	
 	 	 	
 	(iii)	Sole power to dispose or to direct the disposition of:	
 	 	 	
 	 	Opaleye Management Inc. — 0 shares	
 	 	Opaleye, L.P. — 0 shares	
 	 	James Silverman — 0 shares	
 	 	 	
 	(iv)	Shared power to dispose or to direct the disposition of:	
 	 	 	
 	 	Opaleye Management Inc. — 550,000 shares of common stock	
 	 	Opaleye, L.P. — 550,000 shares of common stock	
 	 	James Silverman — 550,000 shares of common stock	
 
Item 5. Ownership of Five Percent or Less of a Class.
 
If this statement is being filed to report the fact that as of the date hereof the Reporting Persons have ceased to be the beneficial owners of more than five percent of the class of securities, check the following [  ].
 
Item 6. Ownership of More than Five Percent on Behalf of Another Person.
 
Not applicable.
 
Item 7. Identification and Classification of the Subsidiary Which Acquired the Security Being Reported by the Parent Holding Company or Control Person.
 
Not applicable.
 
Item 8. Identification and Classification of Members of the Group.
 
Not applicable.
 
Item 9. Notice of Dissolution of Group.
 
Not applicable.
 
Item 10. Certification.
 
By signing below I certify that, to the best of my knowledge and belief, the securities referred to above were not acquired and are not held for the purpose of or with the effect of changing or influencing the control of the issuer of the securities and were not acquired and are not held in connection with or as a participant in any transaction having that purpose or effect.

 
 
CUSIP No. 05360L205	13G	Page 8 of 8 Pages	
 
SIGNATURE
 
After reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct.
 
Date: January 22, 2019	By:	/s/ James Silverman	
 	 	James Silverman	
 	 	 	
 	Opaleye, L.P.	
 	 	 	
Date: January 22, 2019	By:	/s/ James Silverman	
 	Name:	James Silverman	
 	Title:	Managing Member of Opaleye	
 	 	GP LLC, the General Partner of	
 	 	Opaleye, L.P.	
 	 	 	
 	Opaleye Management Inc.	
 	 	 	
Date: January 22, 2019	By:	/s/ James Silverman	
 	Name:	James Silverman	
 	Title:	President	

 
 
JOINT FILING AGREEMENT
 
This Joint Filing Agreement, dated January 22, 2019, is entered into by and among Opaleye Management Inc., a Massachusetts corporation, Opaleye, L.P., a Delaware limited partnership and James Silverman, an individual (collectively referred to herein as (the “Filers”). Each of the Filers may be required to file with the U.S. Securities and Exchange Commission a statement on Schedule 13G with respect to shares of common stock, $0.0001 par value, of Avenue Therapeutics, Inc. beneficially owned by them from time to time. Pursuant to and in accordance with Rule 13(d)(1)(k) promulgated under the Securities Exchange Act of 1934, as amended, the Filers hereby agree to file a single statement on Schedule 13G and/or 13D (and any amendments thereto) on behalf of each of such parties, and hereby further agree to file this Joint Filing Agreement as an exhibit to such statement, as required by such rule. This Joint Filing Agreement may be terminated by any of the Filers upon one week’s prior written notice or such lesser period of notice as the Filers may mutually agree.
 
DATED: January 22, 2019
 
 	By:	/s/ James Silverman	
 	 	James Silverman	
 	 	 	
 	Opaleye, L.P.	
 	 	 	
 	By:	/s/ James Silverman	
 	Name:	James Silverman	
 	Title:	Managing Member of	
 	 	Opaleye GP LLC, the General Partner	
 	 	of Opaleye, L.P.	
 	 	 	
 	Opaleye Management Inc.	
 	 	 	
 	By:	/s/ James Silverman	
 	Name:	James Silverman	
 	Title:	President