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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

________________________________

FORM 10-K

________________________________

(Mark One)


x			ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2021


¨			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 001-40034

VALLON PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

82-4369909

(State or other jurisdiction of
incorporation and organization)

(I.R.S. Employer Identification No.)


100 N. 18th Street, Suite 300, Philadelphia, PA 19103			(267) 607-8255
(Address of principal executive offices, including zip code)			(Registrant’s telephone number, including area code)

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, par value $0.0001 per share

VLON

NASDAQ Capital Market

Securities registered pursuant to Section 12(g) of the Act: None.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No x

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No x

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	¨	Accelerated filer	¨
Non-accelerated filer	x	Smaller reporting company	x
		Emerging growth company	x

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. ¨

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x

As of June 30, 2021 (the last business day of the registrant’s most recently completed second fiscal quarter), the aggregate market value of the registrant’s common stock held by non-affiliates was approximately $22.9 million based on the last reported sale price of the registrant’s common stock on the Nasdaq Capital Market on June 30, 2021.

As of February 11, 2022, 6,812,836 shares of the Registrant’s Common Stock were outstanding.

Ta b le of Contents

TABLE OF CONTENTS

VALLON PHARMACEUTICALS, INC.


		Page No.
	NOTE REGARDING FORWARD-LOOKING STATEMENTS
	RISK FACTOR SUMMARY
	MARKET, INDUSTRY AND OTHER DATA
	PART I	1
I TEM 1.	BUSINESS	1
I TEM 1A.	RISK FACTORS	3
I TEM 1B.	UNRESOLVED STAFF COMMENTS	36
I TEM 2.	PROPERTIES	36
I TEM 3.	LEGAL PROCEEDINGS	36
I TEM 4.	MINE SAFETY DISCLOSURES	36

	PART II	37
ITEM 5.	M ARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUE PURCHASES OF EQUITY SECURITIES	37
I TEM 6.	[RESERVED]	37
I TEM 7.	M ANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	37
I TEM 7A.	Q UANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK	44
I TEM 8.	F INANCIAL STATEMENTS AND SUPPLEMENTARY DATA	44
I TEM 9.	C HANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	44
ITEM 9A.	C ONTROLS AND PROCEDURES	44
I TEM 9B.	O THER INFORMATION	46
ITEM 9C.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	46

	PART III	47
ITEM 10.	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	47
ITEM 11.	E XECUTIVE COMPENSATION	53
ITEM 12.	S ECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS	57
ITEM 13.	C ERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE	59
ITEM 14.	P RINCIPAL ACCOUNTANT FEES AND SERVICES	62

	PART IV	64
ITEM 15.	E XHIBITS AND FINANCIAL STATEMENT SCHEDULES	64
ITEM 16.	FORM 10-K SUMMARY	65
	S

SEC Form 10-K filed by Vallon Pharmaceuticals Inc.