vyne-20240331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

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

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024

☐ 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 001-38356

VYNE THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)


Delaware						45-3757789
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

685 Route 202/206 N, Suite 301

Bridgewater, New Jersey 08807

(Address of principal executive offices including zip code)

(800) 775-7936

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

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

VYNE

The Nasdaq Stock Market LLC

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 ☒ 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 ☒ 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

☒

Smaller reporting company

☒

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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐ No ☒

As of May 2, 2024, there were 14,528,247 shares of the registrant’s Common Stock, par value $0.0001 per share, outstanding.


		Page
Part I	Financial Information	5
Item 1.	Unaudited Financial Statements	5
	Unaudited Condensed Consolidated Balance Sheets	5
	Unaudited Condensed Consolidated Statements Of Operations and Comprehensive Loss	6

	Unaudited Condensed Consolidated Statements Of Changes In Mezzanine Equity and Stockholders' Equity	7
	Unaudited Condensed Consolidated Statements Of Cash Flows	8
	Notes to Unaudited Interim Condensed Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	31
Item 4.	Controls and Procedures	31

Part II	Other Information	32
Item 1.	Legal Proceedings	32
Item 1A.	Risk Factors	32
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	32
Item 3.	Defaults Upon Senior Securities	32
Item 4.	Mine Safety Disclosures	32
Item 5.	Other Information	32
Item 6.	Exhibits	33
SIGNATURES		35


	March 31,		December 31,
	2024		2023
Assets
Current Assets:
Cash and cash equivalents	$	19,065	$	30,620
Restricted cash	54		54

Investment in marketable securities	66,885		62,633




Prepaid and other current assets	4,219		2,656


Total Current Assets	90,223		95,963

Non-current Assets:
Operating lease right-of-use assets	180		207
Non-current prepaid expenses and other assets	1,273		1,515

Total Non-current Assets	1,453		1,722
Total Assets	$	91,676	$	97,685

Liabilities and Stockholders’ Equity
Current Liabilities:
Trade payables	$	2,795	$	1,659
Accrued expenses	3,642		4,119

Employee related obligations	376		1,645

Operating lease liabilities	117		115


Total Current Liabilities	6,930		7,538
Long-term Liabilities:
Non-current operating lease liabilities	63		99

Other liabilities	1,313		1,313
Total Long-term Liabilities	1,376		1,412
Total Liabilities	8,306		8,950

Commitments and Contingencies




Stockholders' Equity:
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at March 31, 2024 and December 31, 2023; no shares issued and outstanding at March 31, 2024 and December 31, 2023	—		—
Common stock: $0.0001 par value; 150,000,000 shares authorized at March 31, 2024 and December 31, 2023; 14,301,688 and 14,098,888 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively	1		1
Additional paid-in capital	781,024		780,044
Accumulated other comprehensive (loss) income	(70)		26
Accumulated deficit	(697,585)		(691,336)
Total Stockholders' Equity	83,370		88,735
Total Liabilities and Stockholders’ Equity	$	91,676	$	97,685


	Three Months Ended March 31,
	2024		2023
Revenues


Royalty revenues	$	98	$	99
Total revenues	98		99



Operating expenses:
Research and development	3,708		2,734
General and administrative	3,770		3,240


Total operating expenses	7,478		5,974
Operating loss	(7,380)		(5,875)

Other income, net	1,139		263
Loss from continuing operations before income taxes	(6,241)		(5,612)
Income tax expense	—		—
Loss from continuing operations	(6,241)		(5,612)
Loss from discontinued operations, net of income taxes	(8)		(10)
Net loss	$	(6,249)	$	(5,622)

Loss per share from continuing operations, basic and diluted	$	(0.15)	$	(1.74)
Loss per share from discontinued operations, basic and diluted	$	0.00	$	0.00
Loss per share, basic and diluted	$	(0.15)	$	(1.74)

Weighted average shares outstanding - basic and diluted	42,581		3,255

Other comprehensive loss:
Unrealized loss on marketable securities, net of tax of $0	(96)		—
Total other comprehensive loss	(96)		—
Comprehensive loss	$	(6,345)	$	(5,622)


	Mezzanine Equity (Convertible Preferred Stock)			Common stock			Additional paid-in capital		Accumulated other comprehensive income (loss)		Accumulated deficit		Total Stockholders' Equity
	Number of shares	Amount		Number of Shares	Amount		Amount
BALANCE AT JANUARY 1, 2023	3,000	$	211	3,229,704	$	—	$	693,937	$	—	$	(662,735)	$	31,202
CHANGES DURING THE PERIOD:
Net loss	—	—		—	—		—		—		(5,622)		(5,622)
Vesting of restricted stock units, net of withholding for tax	—	—		6,989	—		(12)		—		—		(12)
Stock-based compensation	—	—		—	—		856		—		—		856


Redemption of convertible preferred stock	(3,000)	(211)		—	—		—		—		(149)		(149)
Issuance of common stock in at-the-market offering, net of $5 in issuance costs	—	—		34,589	—		156		—		—		156

BALANCE AT MARCH 31, 2023	—	$	—	3,271,282	$	—	$	694,937	$	—	$	(668,506)	$	26,431

BALANCE AT JANUARY 1, 2024	—	$	—	14,098,888	$	1	$	780,044	$	26	$	(691,336)	$	88,735
CHANGES DURING THE PERIOD:
Net loss	—	—		—	—		—		—		(6,249)		(6,249)
Vesting of restricted stock units, net of withholding for tax	—	—		2,809	—		(5)		—		—		(5)
Stock-based compensation	—	—		—	—		985		—		—		985


Cashless exercise of pre-funded warrants	—	—		199,991	—		—		—		—		—
Unrealized losses from marketable securities	—	—		—	—		—		(96)		—		(96)


BALANCE AT MARCH 31, 2024	—	$	—	14,301,688	$	1	$	781,024	$	(70)	$	(697,585)	$	83,370


	March 31, 2024
(in thousands)	Level 1		Level 2		Level 3		Total
Cash and cash equivalents	$	19,065	$	—	$	—	$	19,065
Marketable securities	—		66,885		—		66,885
Total assets	$	19,065	$	66,885	$	—	$	85,950


	December 31, 2023
(in thousands)	Level 1		Level 2		Level 3		Total
Cash and cash equivalents	$	20,353	$	10,267	$	—	$	30,620
Marketable securities	—		62,633		—		62,633
Total assets	$	20,353	$	72,900	$	—	$	93,253


	March 31, 2024
(in thousands)	Amortized cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Value
U.S. Government and agency debt securities	$	42,514	$	—	$	(65)	$	42,449
U.S. Treasury bills	24,441		—		(5)		24,436
Total	$	66,955	$	—	$	(70)	$	66,885


	Three Months Ended March 31, 2024
	Award amount	Exercise price range		Vesting period	Expiration

Options	575,000	$	2.33	1 year - 4 years	10 years
RSUs	435,000	$	—	4 years	—


	Three Months Ended March 31,
	2024
Fair value of common stock	$1.88 - $1.94
Dividend yield	0	%
Expected volatility	104.63% - 105.71%
Risk-free interest rate	3.95	%
Expected term	6 years


	Three Months Ended March 31,				Increase/(Decrease)		Increase/(Decrease)
(in thousands, except %)	2024		2023		$		%
Revenues
Royalty revenues	$	98	$	99	$	(1)	(1.0)	%
Total revenues	98		99		(1)		(1.0)	%

Operating expenses:
Research and development	3,708		2,734		974		35.6	%
General and administrative	3,770		3,240		530		16.4	%
Total operating expenses	7,478		5,974		1,504		25.2	%
Operating loss	(7,380)		(5,875)		1,505		25.6	%

Other income, net	1,139		263		876		*
Loss from continuing operations before income taxes	(6,241)		(5,612)		629		11.2	%
Income tax expense	—		—		—		*
Loss from continuing operations	(6,241)		(5,612)		629		11.2	%
Loss from discontinued operations, net of income taxes	(8)		(10)		(2)		(20.0)	%
Net loss	$	(6,249)	$	(5,622)	$	627	11.2	%


	March 31,
	2024	2023
Outstanding stock options and RSUs	2,210,974	290,121
Warrants	27,509	27,509


	Three Months Ended March 31,
(in thousands)	2024		2023
Net cash (used in) / provided by:
Operating activities	$	(7,982)	$	(5,478)
Investing activities	$	(3,569)	$	5,000
Financing activities	$	(4)	$	(217)



			VYNE Therapeutics Inc.

			By:			/s/ David Domzalski
						David Domzalski Chief Executive Officer
						(On Behalf of the Registrant and as Principal Executive Officer)

			By:			/s/ Tyler Zeronda
						Tyler Zeronda Chief Financial Officer
						(Principal Financial Officer and Principal Accounting Officer)

SEC Form 10-Q filed by VYNE Therapeutics Inc.