vyne-20220630

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 JUNE 30, 2022

☐ 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.)

520 U.S. Highway 22, Suite 204

Bridgewater, New Jersey 08807

(Address of principal executive offices including zip code)

(800) 775-7936

(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

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 August 4, 2022, there were 58,005,568 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	6

	Unaudited Condensed Consolidated Statements Of Changes In 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	21
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	30
Item 4.	Controls and Procedures	30

Part II	Other Information	31
Item 1.	Legal Proceedings	31
Item 1A.	Risk Factors	31
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	31
Item 3.	Defaults Upon Senior Securities	31
Item 4.	Mine Safety Disclosures	31
Item 5.	Other Information	31
Item 6.	Exhibits	32
SIGNATURES		34


	June 30		December 31
	2022		2021
Assets
Current Assets:
Cash and cash equivalents	$	42,814	$	42,250
Restricted cash	—		605



Trade receivables, net of allowances	304		7,583
Amount due from sale of MST Franchise	5,000		—

Prepaid expenses and other assets	3,772		4,565
Operating lease right of use assets	30		338
Discontinued operations - current assets	—		7,845
Total Current Assets	51,920		63,186
Property and equipment, net	298		354

Non-current prepaid expenses and other assets	2,974		3,506

Total Assets	$	55,192	$	67,046

Liabilities and Stockholders’ Equity
Current Liabilities:
Trade payables	$	1,431	$	6,510
Accrued expenses	3,514		8,593

Employee related obligations	1,603		2,752
Liability for employee severance benefits	256		206
Operating lease liabilities	31		349








Total Liabilities	6,835		18,410
Commitments and Contingencies (Note 7)
Stockholders' Equity:
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at June 30, 2022 and December 31, 2021; no shares issued and outstanding at June 30, 2022 and December 31, 2021	—		—
Common stock: $0.0001 par value; 150,000,000 shares authorized at June 30, 2022 and December 31, 2021; 58,005,616 and 53,577,744 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively	6		5
Additional paid-in capital	691,682		688,156
Accumulated deficit	(643,331)		(639,525)

Total Stockholders' Equity	48,357		48,636
Total Liabilities and Stockholders’ Equity	$	55,192	$	67,046


	Three months ended June 30				Six months ended June 30
	2022		2021		2022		2021
Revenues


Royalty revenues	$	126	$	295	304		525
Total Revenues	126		295		304		525



Operating expenses:
Research and development	4,108		5,048		8,560		9,303
Selling, general and administrative	4,305		4,789		8,722		10,521


Total operating expenses	8,413		9,837		17,282		19,824
Operating loss	(8,287)		(9,542)		(16,978)		(19,299)
Interest expense	—		(1,074)		—		(2,136)
Other income (expense)	52		(69)		49		(126)
Loss from continuing operations before income taxes	(8,235)		(10,685)		(16,929)		(21,561)
Income tax expense	—		—		—		—
Loss from continuing operations	(8,235)		(10,685)		(16,929)		(21,561)
Income (loss) from discontinued operations, net of income taxes	(241)		(9,239)		13,123		(18,913)
Net loss	$	(8,476)	$	(19,924)	$	(3,806)	$	(40,474)

Loss per share from continuing operations, basic and diluted	$	(0.14)	$	(0.21)	$	(0.30)	$	(0.43)
Income (loss) per share from discontinued operations, basic and diluted	$	(0.01)	$	(0.18)	$	0.23	$	(0.38)
Loss per share, basic and diluted	$	(0.15)	$	(0.39)	$	(0.07)	$	(0.81)

Weighted average shares outstanding - basic and diluted	57,930		51,411		56,665		50,162


	Common stock			Additional paid-in capital		Accumulated deficit		Total
	Number of Shares	Amounts		Amounts
BALANCE AT JANUARY 1, 2021	43,205,221	$	4	$	603,685	$	(566,196)	$	37,493
CHANGES DURING THE PERIOD:
Net loss	—	—		—		(40,474)		(40,474)
Exercise of options, vesting of restricted stock units and shares issued under employee stock purchase plan	254,351	—		403		—		403
Stock-based compensation	—	—		4,343		—		4,343


Issuance of common stock, net of $3,991 in issuance costs	8,052,273	1		73,127		—		73,128

BALANCE AT JUNE 30, 2021	51,511,845	$	5	$	681,558	$	(606,670)	$	74,893

BALANCE AT JANUARY 1, 2022	53,577,744	$	5	$	688,156	$	(639,525)	$	48,636
CHANGES DURING THE PERIOD:
Net loss	—	—		—		(3,806)		(3,806)
Vesting of restricted stock units, net of withholding tax and shares issued under employee stock purchase plan	172,424	—		—		—		—
Stock-based compensation	—	—		2,056		—		2,056
Issuance of commitment shares in March 2022	1,667,593	—		—		—		—
Issuance of common stock, net of $135 in issuance costs	2,587,855	1		1,470		—		1,471

BALANCE AT JUNE 30, 2022	58,005,616	$	6	$	691,682	$	(643,331)	$	48,357


	June 30,
	2022	2021
Outstanding stock options, RSUs and shares under the ESPP	5,866,862	5,365,232
Warrants	495,165	495,165


	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2022		2021		2022		2021
Product sales	$	—	$	3,963	$	106	$	7,852

Cost of goods sold	—		795		80		1,396

Operating expenses:
Research and development	—		1,361		—		3,439
Selling, general and administrative	241		11,046		(92)		21,930
Total operating expenses	241		12,407		(92)		25,369
Income (loss) from discontinued operations	(241)		(9,239)		118		(18,913)

SEC Form 10-Q filed by VYNE Therapeutics Inc.