vyne-20240930

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 SEPTEMBER 30, 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 November 1, 2024, there were 14,751,433 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	9
	Notes to Unaudited Interim Condensed Consolidated Financial Statements	10
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	25
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	34
Item 4.	Controls and Procedures	34

Part II	Other Information	35
Item 1.	Legal Proceedings	35
Item 1A.	Risk Factors	35
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	35
Item 3.	Defaults Upon Senior Securities	35
Item 4.	Mine Safety Disclosures	35
Item 5.	Other Information	35
Item 6.	Exhibits	36
SIGNATURES		37


	September 30,		December 31,
	2024		2023
Assets
Current Assets:
Cash and cash equivalents	$	16,272	$	30,620
Restricted cash	47		54

Investment in marketable securities	53,913		62,633




Prepaid and other current assets	3,303		2,656


Total Current Assets	73,535		95,963

Non-current Assets:
Operating lease right-of-use assets	122		207
Non-current prepaid expenses and other assets	2,541		1,515

Total Non-current Assets	2,663		1,722
Total Assets	$	76,198	$	97,685

Liabilities and Stockholders’ Equity
Current Liabilities:
Trade payables	$	3,986	$	1,659
Accrued expenses	6,168		4,119

Employee related obligations	1,071		1,645
Operating lease liabilities	123		115
Other current liabilities	1,313		—


Total Current Liabilities	12,661		7,538
Long-term Liabilities:
Non-current operating lease liabilities	—		99

Other liabilities	—		1,313
Total Long-term Liabilities	—		1,412
Total Liabilities	12,661		8,950

Commitments and Contingencies




Stockholders' Equity:
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023	—		—
Common stock: $0.0001 par value; 150,000,000 shares authorized at September 30, 2024 and December 31, 2023; 14,751,433 and 14,098,888 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	1		1
Additional paid-in capital	782,650		780,044
Accumulated other comprehensive income	34		26
Accumulated deficit	(719,148)		(691,336)
Total Stockholders' Equity	63,537		88,735
Total Liabilities and Stockholders’ Equity	$	76,198	$	97,685


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Revenues


Royalty revenues	$	121	$	114	$	417	$	348
Total revenues	121		114		417		348



Operating expenses:
Research and development	10,248		3,318		21,262		13,284
General and administrative	2,964		3,030		10,022		9,490


Total operating expenses	13,212		6,348		31,284		22,774
Operating loss	(13,091)		(6,234)		(30,867)		(22,426)

Other income, net	934		163		3,074		706
Loss from continuing operations before income taxes	(12,157)		(6,071)		(27,793)		(21,720)
Income tax expense	—		—		—		—
Loss from continuing operations	(12,157)		(6,071)		(27,793)		(21,720)
Loss from discontinued operations, net of income taxes	—		(513)		(19)		(544)
Net loss	$	(12,157)	$	(6,584)	$	(27,812)	$	(22,264)

Loss per share from continuing operations, basic and diluted	$	(0.29)	$	(1.85)	$	(0.65)	$	(6.66)
Income (loss) per share from discontinued operations, basic and diluted	$	0.00	$	(0.16)	$	0.00	$	(0.17)
Loss per share, basic and diluted	$	(0.29)	$	(2.01)	$	(0.65)	$	(6.82)

Weighted average shares outstanding - basic and diluted	42,587		3,282		42,592		3,271

Other comprehensive income:
Unrealized gains on marketable securities, net of tax of $0	92		—		8		—
Total other comprehensive income	92		—		8		—
Comprehensive loss	$	(12,065)	$	(6,584)	$	(27,804)	$	(22,264)


	Mezzanine Equity (Convertible Preferred Stock)			Common stock			Additional paid-in capital		Accumulated other comprehensive income		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	—	—		—	—		—		—		(22,264)		(22,264)
Vesting of restricted stock units, net of withholding for tax and shares issued under employee stock purchase plan	—	—		40,488	—		(35)		—		—		(35)
Stock-based compensation	—	—		—	—		2,595		—		—		2,595


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 SEPTEMBER 30, 2023	—	$	—	3,304,781	$	—	$	696,653	$	—	$	(685,148)	$	11,505

BALANCE AT JANUARY 1, 2024	—	$	—	14,098,888	$	1	$	780,044	$	26	$	(691,336)	$	88,735
CHANGES DURING THE PERIOD:
Net loss	—	—		—	—		—		—		(27,812)		(27,812)
Vesting of restricted stock units, net of withholding for tax and shares issued under employee stock purchase plan	—	—		12,722	—		2		—		—		2
Stock-based compensation	—	—		—	—		2,604		—		—		2,604


Cashless exercise of pre-funded warrants	—	—		639,823	—		—		—		—		—
Unrealized gains from marketable securities	—	—		—	—		—		8		—		8


BALANCE AT SEPTEMBER 30, 2024	—	$	—	14,751,433	$	1	$	782,650	$	34	$	(719,148)	$	63,537


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2024		2023		2024		2023
Product sales, net	$	—	$	(498)	$	—	$	(498)



Operating expenses:

General and administrative	—		15		19		46
Total operating expenses	—		15		19		46


Loss from discontinued operations, before taxes	—		(513)		(19)		(544)
Income tax expense	—		—		—		—
Net loss from discontinued operations	$	—	$	(513)	$	(19)	$	(544)


	September 30, 2024
(in thousands)	Level 1		Level 2		Level 3		Total
Cash and cash equivalents	$	11,339	$	4,933	$	—	$	16,272
Marketable securities	—		53,913		—		53,913
Total assets	$	11,339	$	58,846	$	—	$	70,185


	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


	September 30,
	2024	2023
Outstanding stock options and RSUs	2,378,566	240,401
Warrants	27,509	27,509

SEC Form 10-Q filed by VYNE Therapeutics Inc.