Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 22, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38356 | ||
Entity Registrant Name | VYNE THERAPEUTICS INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 45-3757789 | ||
Entity Address, Address Line One | 685 Route 202/206 N, Suite 301 | ||
Entity Address, City or Town | Bridgewater | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 08807 | ||
City Area Code | 800 | ||
Local Phone Number | 775-7936 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 | ||
Trading Symbol | VYNE | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 13.1 | ||
Entity Common Stock, Shares Outstanding | 14,098,888 | ||
Documents Incorporated by Reference | None. | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001566044 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Audit Information [Abstract] | |
Auditor Name | Baker Tilly US, LLP |
Auditor Location | Tewksbury, Massachusetts |
Auditor Firm ID | 23 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 30,620,000 | $ 30,908,000 |
Restricted cash | 54,000 | 67,000 |
Investment in marketable securities (Note 6) | 62,633,000 | 0 |
Amount due from sale of MST Franchise | 0 | 5,000,000 |
Prepaid and other current assets | 2,656,000 | 2,300,000 |
Total Current Assets | 95,963,000 | 38,275,000 |
Non-current Assets: | ||
Operating lease right of use assets (Note 9) | 207,000 | 0 |
Non-current prepaid expenses and other assets | 1,515,000 | 2,483,000 |
Total Non-current Assets | 1,722,000 | 2,483,000 |
Total Assets | 97,685,000 | 40,758,000 |
Current Liabilities: | ||
Trade payables | 1,659,000 | 2,386,000 |
Accrued expenses (Note 8) | 4,119,000 | 4,381,000 |
Employee-related obligations | 1,645,000 | 2,372,000 |
Liability for employee severance benefits | 0 | 206,000 |
Operating lease liabilities (Note 9) | 115,000 | 0 |
Total Current Liabilities | 7,538,000 | 9,345,000 |
Long-term Liabilities: | ||
Non-current operating lease liabilities (Note 9) | 99,000 | 0 |
Other liabilities | 1,313,000 | 0 |
Total Long-term Liabilities | 1,412,000 | 0 |
Total Liabilities | 8,950,000 | 9,345,000 |
Commitments and Contingencies (Note 11) | ||
Mezzanine Equity: | ||
Convertible Preferred Stock: $0.0001 par value; 20,000,000 shares authorized at December 31, 2023 and December 31, 2022; Series A Preferred Stock: 0 and 3,000 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively (Note 12) | 0 | 211,000 |
Shareholders' Equity: | ||
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at December 31, 2023 and December 31, 2022, respectively; no shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 0 | 0 |
Common stock: $0.0001 par value; 150,000,000 shares authorized at December 31, 2023 and December 31, 2022; 14,098,888 and 3,229,704 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 1,000 | 0 |
Additional paid-in capital | 780,044,000 | 693,937,000 |
Accumulated other comprehensive income | 26,000 | 0 |
Accumulated deficit | (691,336,000) | (662,735,000) |
Total Shareholders' Equity | 88,735,000 | 31,202,000 |
Total Liabilities, Mezzanine Equity and Shareholders’ Equity | $ 97,685,000 | $ 40,758,000 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Convertible preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Convertible preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Convertible preferred stock, shares outstanding (in shares) | 0 | 3,000 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 14,098,888 | 3,229,704 |
Common stock, shares outstanding (in shares) | 14,098,888 | 3,229,704 |
Series A Preferred Stock | ||
Convertible preferred stock, shares issued (in shares) | 0 | 3,000 |
Convertible preferred stock, shares outstanding (in shares) | 0 | 3,000 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Total Revenues | $ 424 | $ 477 |
Operating Expenses: | ||
Research and development | 16,307 | 18,385 |
General and administrative | 13,375 | 16,387 |
Total Operating Expenses | 29,682 | 34,772 |
Operating Loss | (29,258) | (34,295) |
Other income, net | 1,386 | 363 |
Loss from continuing operations before income taxes | (27,872) | (33,932) |
Income tax expense | 0 | 13 |
Loss from continuing operations | (27,872) | (33,945) |
(Loss) income from discontinued operations, net of income taxes | (580) | 10,735 |
Net Loss | $ (28,452) | $ (23,210) |
Loss per share from continuing operations, basic (in dollars per share) | $ (2.72) | $ (10.65) |
Loss per share from continuing operations, diluted (in dollars per share) | (2.72) | (10.65) |
(Loss) income per share from discontinuing operations, basic (in dollars per share) | (0.06) | 3.37 |
(Loss) income per share from discontinuing operations, diluted (in dollars per share) | (0.06) | 3.37 |
Loss per share basic (in dollars per share) | (2.78) | (7.28) |
Loss per share diluted (in dollars per share) | $ (2.78) | $ (7.28) |
Weighted average shares outstanding - basic (in shares) | 10,273 | 3,186 |
Weighted average shares outstanding - diluted (in shares) | 10,273 | 3,186 |
Other comprehensive income: | ||
Unrealized gain on marketable securities, net of tax of $0 | $ 26 | $ 0 |
Total other comprehensive income | 26 | 0 |
Comprehensive loss | $ (28,426) | $ (23,210) |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Income Statement [Abstract] | |
Unrealized income on marketable securities, tax | $ 0 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Total | At-the-market Offering | Private Placement | Common stock | Common stock At-the-market Offering | Common stock Private Placement | Additional paid-in capital | Additional paid-in capital At-the-market Offering | Additional paid-in capital Private Placement | Accumulated other comprehensive income | Accumulated deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 0 | ||||||||||
Beginning balance at Dec. 31, 2021 | $ 0 | ||||||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||||||
Issuance of convertible preferred stock, net of issuance costs (in shares) | 3,000 | ||||||||||
Issuance of convertible preferred stock, net of issuance costs | $ 211 | ||||||||||
Ending balance (in shares) at Dec. 31, 2022 | 3,000 | ||||||||||
Ending balance at Dec. 31, 2022 | $ 211 | ||||||||||
Beginning balance (shares) at Dec. 31, 2021 | 2,976,541 | ||||||||||
Beginning balance at Dec. 31, 2021 | 48,636 | $ 5 | $ 688,156 | $ 0 | $ (639,525) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Reclassification due to reverse stock split | 0 | $ (5) | 5 | ||||||||
Vesting of restricted stock units, net of withholding for tax and shares issued under employee share purchase plan (in shares) | 16,749 | ||||||||||
Vesting of restricted stock units, net of withholding for tax, and shares issued under employee share purchase plan | 9 | 9 | |||||||||
Stock-based compensation | 4,297 | 4,297 | |||||||||
Issuance of common stock, net of issuance costs (in shares) | 143,770 | ||||||||||
Issuance of common stock, net of issuance costs | $ 1,470 | $ 1,470 | |||||||||
Issuance of equity line of credit commitment shares (in shares) | 92,644 | ||||||||||
Unrealized gains from marketable securities | 0 | ||||||||||
Net income (Loss) | $ (23,210) | (23,210) | |||||||||
Ending balance (shares) at Dec. 31, 2022 | 3,229,704 | 3,229,704 | |||||||||
Ending balance at Dec. 31, 2022 | $ 31,202 | $ 0 | 693,937 | 0 | (662,735) | ||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||||||
Redemption of convertible preferred stock (in shares) | (3,000) | ||||||||||
Redemption of convertible preferred stock | $ (211) | ||||||||||
Ending balance (in shares) at Dec. 31, 2023 | 0 | ||||||||||
Ending balance at Dec. 31, 2023 | $ 0 | ||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Vesting of restricted stock units, net of withholding for tax and shares issued under employee share purchase plan (in shares) | 50,214 | ||||||||||
Vesting of restricted stock units, net of withholding for tax, and shares issued under employee share purchase plan | (18) | (18) | |||||||||
Stock-based compensation | 3,305 | 3,305 | |||||||||
Issuance of common stock, net of issuance costs (in shares) | 34,589 | ||||||||||
Issuance of common stock, net of issuance costs | $ 156 | $ 156 | |||||||||
Redemption of convertible preferred stock | (149) | (149) | |||||||||
Issuance of common stock and pre-funded warrants, under Private Placement, net of $5,486 of issuance costs (in shares) | 10,652,543 | ||||||||||
Issuance of common stock and pre-funded warrants in Private Placement, net of $5,486 in issuance costs | $ 82,665 | $ 1 | $ 82,664 | ||||||||
Cashless exercise of pre-funded warrants (in shares) | 131,838 | ||||||||||
Unrealized gains from marketable securities | 26 | 26 | |||||||||
Net income (Loss) | $ (28,452) | (28,452) | |||||||||
Ending balance (shares) at Dec. 31, 2023 | 14,098,888 | 14,098,888 | |||||||||
Ending balance at Dec. 31, 2023 | $ 88,735 | $ 1 | $ 780,044 | $ 26 | $ (691,336) |
CONSOLIDATED STATEMENTS OF CH_2
CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND SHAREHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Convertible Preferred Stock | ||
Payments of stock issuance costs | $ 89 | |
At-the-market Offering | ||
Payments of stock issuance costs | $ 5 | $ 135 |
Private Placement | ||
Payments of stock issuance costs | $ 5,486 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (28,452) | $ (23,210) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 0 | 72 |
Stock-based compensation | 3,305 | 4,297 |
Loss from sale and disposal of fixed assets | 0 | 282 |
Gain on the sale of the MST Franchise | 0 | (12,918) |
Amortization of premium or discount on marketable securities | (255) | 0 |
Unrealized gains on cash equivalents | 1 | 0 |
Changes in operating assets and liabilities: | ||
Decrease in inventory | 0 | 97 |
Decrease in trade receivables, prepaid and other current assets and operating lease right of use asset | 405 | 11,210 |
Decrease in trade payables, accrued expenses, employee related obligations, liability for employee severance benefits and other long-term liabilities | (559) | (8,681) |
Increase (decrease) in operating lease liabilities | 214 | (349) |
Net cash used in operating activities | (25,341) | (29,200) |
Cash Flows From Investing Activities: | ||
Proceeds from the sale of the MST Franchise | 5,000 | 15,667 |
Purchases of marketable securities | (62,354) | 0 |
Net cash (used in) provided by investing activities | (57,354) | 15,667 |
Cash Flows From Financing Activities: | ||
(Redemption) proceeds of convertible preferred stock | (360) | |
(Redemption) proceeds of convertible preferred stock | 211 | |
Withholdings from exercise of options and issuance of shares for stock-based compensation arrangements, net | (67) | (28) |
Net cash provided by financing activities | 82,394 | 1,653 |
Decrease in cash, cash equivalents and restricted cash | (301) | (11,880) |
Cash, cash equivalents and restricted cash at beginning of the year | 30,975 | 42,855 |
Cash, cash equivalents and restricted cash at end of the year | 30,674 | 30,975 |
Cash and cash equivalents | 30,620 | 30,908 |
Restricted cash | 54 | 67 |
Total cash, cash equivalents and restricted cash | 30,674 | 30,975 |
Supplementary information on investing and financing activities not involving cash flows: | ||
Accretion of preferred stock | 149 | 0 |
Issuance of shares under employee share purchase plan | 48 | 37 |
Cashless exercise of warrants | 132 | 0 |
Amount due from sale of MST Franchise | 0 | 5,000 |
Additions to operating lease right of use assets | 207 | 0 |
Additions to operating lease liabilities | 214 | 0 |
Supplemental disclosure of cash flow information: | ||
Interest received | 1,139 | 446 |
Private Placement | ||
Cash Flows From Financing Activities: | ||
Proceeds related to the issuance of common shares and pre-funded warrants through private placement, net of issuance costs | 82,665 | 0 |
At-the-market Offering | ||
Cash Flows From Financing Activities: | ||
Proceeds related to the issuance of common shares through at-the-market offerings, net of issuance costs | $ 156 | $ 1,470 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NATURE OF OPERATIONS Company Overview VYNE Therapeutics Inc. (the "Company") is a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions. In August 2021, the Company entered into a transaction with Tay Therapeutics Ltd., formerly known as In4Derm Limited "Tay"), providing the Company with exclusive worldwide rights to research, develop and commercialize products containing bromodomain and extra-terminal domain (“BET”) inhibitors for the treatment of any disease, disorder or condition in humans. Through its access to this library of new chemical BET inhibitor compounds, the Company plans to develop product candidates for a diverse set of indications. Based on data generated to date, the Company has chosen to focus its initial efforts for this platform on select therapeutic areas in immuno-inflammatory disease. The Company's lead program is VYN201, a locally administered pan-bromodomain ("BD") BET inhibitor designed as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways while providing low systemic exposure. In preclinical testing, VYN201 produced consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity across a variety of inflammatory and fibrotic models. The Company's second program is VYN202, an oral small molecule BD2-selective BET inhibitor. VYN202 has been designed to achieve potential class-leading selectivity (BD2 vs. BD1), maximum potency versus BD2 and optimal oral bioavailability. By maximizing BD2 selectivity, the Company believes VYN202 has the potential to be a more conveniently-administered non-biologic treatment option for both acute control and chronic management of immuno-inflammatory indications, where the damaging effects of unrestricted inflammatory signaling activity are common. The Company intends to advance its product candidates through clinical development toward regulatory approval. As part of its strategy to maximize the value of its pipeline, the Company may partner with larger pharmaceutical companies to expand and accelerate the development of its programs and explore therapeutic areas outside of its core focus in immunology. For additional information regarding the sale of the Company's legacy commercial business (the "MST Franchise") to Journey Medical Corporation in January 2022 and the Company's licensing arrangements with Tay, see "—Note 3 - Strategic Agreements." The Company is a Delaware corporation, has its principal executive offices in Bridgewater, New Jersey and operates as one business segment. Reverse stock split and recasting of per-share amounts On February 8, 2023, the Company's board of directors approved a 1-for-18 reverse stock split of its outstanding shares of common stock. The reverse stock split was effected on February 10, 2023 at 5:01 p.m. Eastern time. At the effective time, every 18 issued and outstanding shares of the Company's common stock were converted into one share of common stock. No fractional shares were issued in connection with the reverse stock split, and in lieu thereof, each stockholder holding fractional shares was entitled to receive a cash payment (without interest or deduction) in an amount equal to such stockholder’s respective pro rata share of the total net proceeds from the Company’s transfer agent's sale of all fractional shares at the then-prevailing prices on the open market. A proportionate adjustment was also made to the maximum number of shares issuable under the Company’s 2019 Equity Incentive Plan, 2018 Omnibus Incentive Plan and 2019 Employee Share Purchase Plan. The number of authorized shares of the Company's common stock and the par value of each share of common stock remained unchanged. Unless noted, all common shares and per share amounts contained in the consolidated financial statements have been retroactively adjusted to reflect the 1-for-18 reverse stock split. Securities Purchase Agreement On October 27, 2023, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain institutional and other accredited investors (collectively, the “Purchasers”), pursu ant to which the Company agreed to sell and issue to the Purchasers in a private placement transaction (the “Private Placement”) (i) 10,652,543 shares of the Company’s common stock and (ii) with respect to certain Purchasers, pre-funded warrants to purchase 28,614,437 shares of common stock in lieu of shares (the “Pre-Funded Warrants”). The purchase price per share of common stock was $2.245 per share (the “Stock Purchase Price”) and the purchase price for the Pre-Funded Warrants was the Stock Purchase Price minus $0.0001 per Pre-Funded Warrant. On November 1, 2023, the Company received gross proceeds of $88.2 million from the Private Placement. This transaction resulted in $5.5 million of issuance costs and net proceeds of $82.7 million as of December 31, 2023. Liquidity and Capital Resources As of December 31, 2023, the Company had cash, cash equivalents, restricted cash and marketable securities of $93.3 million and an accumulated deficit of $691.3 million. For the year ended December 31, 2023, the Company incurred a net loss of $28.5 million and used $25.3 million of cash in operations. The net loss was comprised of a $27.9 million loss from continuing operations and a $0.6 million of loss from discontinued operations. The Company had no outstanding debt as of December 31, 2023. Other than in connection with its legacy commercial business, the Company has funded its operations primarily through private and public placements of its equity, debt and warrants and through fees, cost reimbursements and payments received from its licensees. The Company has incurred losses and experienced negative operating cash flows since its inception and anticipates that it will continue to incur losses until such a time when its product candidates, if approved, are commercially successful, if at all. The Company will not generate any revenue from any current or future product candidates unless and until it obtains regulatory approval and commercializes such products. If the Company's available cash, cash equivalents, restricted cash and marketable securities are insufficient to satisfy its liquidity requirements, the Company may need to raise additional capital to fund its operations. No assurance can be given as to whether additional needed financing will be available on terms acceptable to the Company, if at all. If sufficient funds on acceptable terms are not available when needed, the Company may be required to suspend or forego certain planned activities. Failure to manage discretionary spending or raise additional financing, as needed, would adversely impact the Company’s ability to achieve its intended business objectives and have an adverse effect on its results of operations and future prospects. The amount of proceeds the Company may be able to raise pursuant to its shelf registration statement on Form S-3 is limited. As of the filing of this Annual Report on Form 10-K, the Company is subject to the general instructions of Form S-3 known as the "baby shelf rules." Under these rules, the amount of funds the Company can raise through primary public offerings of securities in any 12-month period using its registration statement on Form S-3 is limited to one-third of the aggregate market value of the shares of the Company's common stock held by its non-affiliates. Therefore, the Company will be limited in the amount of proceeds it is able to raise by selling shares of common stock using its Form S-3 until such time as the Company's public float exceeds $75.0 million. In accordance with Accounting Standards Codification (“ASC”) Subtopic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that its audited consolidated financial statements are issued. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | SIGNIFICANT ACCOUNTING POLICIES: a. Basis of presentation The Company’s consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). b. Principles of consolidation The consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been eliminated upon consolidation. c. Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. Significant items subject to such estimates and assumptions include product returns and research and development accruals. Actual results could differ from the Company’s estimates. d. Foreign Currency Translation Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items in the statements of operations (indicated below), the following exchange rates are used: (i) for transactions - exchange rates at transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation and amortization, etc.) - historical exchange rates. Currency transaction gains and losses are presented in financial income or expenses, as appropriate. e. Cash and cash equivalents The Company considers as cash equivalents all short-term, highly liquid investments, which include short-term bank deposits, treasury bills and money market funds with original maturities of three months or less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash. f. Restricted Cash As of December 31, 2023 and 2022, the Company had restricted cash of $0.1 million representing bank guarantees. g. Marketable securities Marketable securities with original maturities of greater than three months and remaining maturities of less than one year from the balance sheet date are classified as short-term. Marketable securities with remaining maturities of greater than one year from the balance sheet date are classified as long-term. The Company classifies all marketable securities as available-for-sale debt securities. The Company’s marketable securities are measured and reported at fair value using either quoted prices in active markets for identical securities or quoted prices in markets that are not active for identical or similar securities. Unrealized gains and losses are reported as a separate component of shareholders’ equity. The cost of securities sold is determined on a specific identification basis, and realized gains and losses, if any, are included in other income, net within the consolidated statement of operations and comprehensive loss. h. Property and equipment 1) Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2) The Company’s property and equipment are depreciated by the straight-line method on the basis of their estimated useful life. Annual rates of depreciation are as follows: Estimated Useful Life Computers 3 - 7 years Laboratory equipment 5 - 14 years Office furniture and equipment 7 - 14 years Leasehold improvements are amortized by the straight-line method over the expected lease term, which is shorter than the estimated useful life of the improvements. i. Impairment of long-lived assets The Company tests long-lived assets for impair ment whenever events or circumstances present an indication of impairment. If the sum of expected future cash flows (undiscounted and without interest charges) of the assets is less than the carrying amount of such assets, an impairment loss would be recognized. The assets would be written down to their estimated fair values, calculated based on the present value of expected future cash flows (discounted cash flows), or some other fair value measure. j. Credit losses An allowance is maintained for potential credit losses in accordance with accounting standards update ("ASU") No. 2016-13. The Company evaluates its allowance based on expected losses rather than incurred losses, which is known as the current expected credit loss (“CECL”) model. The allowance is determined using the loss rate approach and is measured on a collective (pool) basis when similar risk characteristics exist. Where financial instruments do not share risk characteristics, they are evaluated on an individual basis. The allowance is based on relevant available information, from internal and external sources, relating to past events, current conditions, and reasonable and supportable forecasts.. T rade receivable balances are written off against the allowance when it is deemed probable that the receivable will not be collected. Trade receivables, net are stated net of reserves for certain sales allowances and credit losses. Credit losses were not material for the years ended December 31, 2023 and 2022. k. Leases The Company's lease portfolio mainly consists of office space. Leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. Operating lease assets represent the Company’s right to use an underlying asset for the lease term whereas lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Leases with an initial term of 12 months or less are not recorded on the consolidated balance sheet. Operating lease expense is recognized on a straight-line basis over the expected lease term. l. Contingencies Certain conditions may exist as of the date of the consolidated financial statements, which may result in a loss to the Company, but which will only be resolved when one or more future events occur or fail to occur. The Company’s management assesses such contingent liabilities and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company’s management evaluates the perceived merits of any legal proceedings or unasserted claims as well as the perceived merits of the amount of relief sought or expected to be sought. Management applies the guidance in ASC 450-20-25 when assessing losses resulting from contingencies. If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability is recorded as accrued expenses in the Company’s financial statements. If the assessment indicates that a potential material loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, then the nature of the contingent liability, together with an estimate of the range of possible loss if determinable and material are disclosed. Loss contingencies considered to be remote by management are generally not disclosed unless they involve guarantees, in which case the guarantees are disclosed. m. Share-based compensation The Company accounts for employees’ and directors’ share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period using the straight-line method. Forfeitures are recognized as they occur. Share-based payments related to the employee share purchase plan (“ESPP”) are recognized based on the fair value of each award estimated on the first day of the offering period and recognized as an expense over the offering period using the straight-line method. The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the straight-line method. n. Revenue recognition The Company accounts for its revenue transactions under Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 606, Revenue from Contracts with Customers. In accordance with ASC Topic 606, the Company recognizes revenues when its customers obtain control of its product for an amount that reflects the consideration it expects to receive from its customers in exchange for that product. To determine revenue recognition for contracts that are determined to be in scope of ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when such performance obligation is satisfied. As a result of the disposition of the MST Franchise in January 2022, the Company no longer has any revenue generating products; however, it still may receive royalty revenues from the sale of specified products (see Note 4, Discontinued Operations). Royalty Revenues and Collaboration Agreements The Company is entitled to royalty payments with respect to sales of a product developed by a customer in collaboration with the Company. This product was not part of the MST Franchise that was sold in January 2022. Royalties are recognized as revenue when the product is sold by the customer. Revenues in the amount of $0.4 million and $0.5 million were recorded during the year ended December 31, 2023 and 2022, respectively. For collaboration agreements under ASC 606, the Company identifies the contract, identifies the performance obligations, determines the transaction price, allocates the contract transaction price to the performance obligations, and recognizes the revenue when (or as) the performance obligation is satisfied. The Company identifies the performance obligations included within the agreement and evaluate which performance obligations are distinct. Upfront payments for licenses are evaluated to determine if the license is capable of being distinct from the obligations to participate on certain development and/or commercialization committees with the collaboration partners and supply manufactured drug product for clinical trials. For performance obligations that are satisfied over time, the Company utilizes the input method and revenue is recognized by consistently applying a method of measuring progress toward complete satisfaction of that performance obligation. The Company periodically reviews its estimated periods of performance based on the progress under each arrangement and accounts for the impact of any changes in estimated periods of performance on a prospective basis. Milestone payments are a form of variable consideration as the payments are contingent upon achievement of a substantive event. Milestone payments are estimated and included in the transaction price when the Company determines that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods. Product Revenues, net The Company’s net product revenues were generated through sales of AMZEEQ, which was approved by the FDA in October 2019 and was commercially launched in the United States in January 2020, and ZILXI, which was approved by the FDA in May 2020 and was commercially launched in the United States in October 2020. The Company sold the MST Franchise on January 12, 2022 and, as such, the Company no longer generates revenue from the sale of these products. The following is a description of the Company's accounting policies related to the sales of AMZEEQ and ZILXI. Product sales The Company’s customers were a limited number of national and select regional wholesalers (the “distributors”) and certain independent and specialty pharmacies (together, the “customers”). These distributors would subsequently resell the product, primarily to retail pharmacies that dispense the product to patients. Net product revenue was typically recognized when customers obtained control of the Company’s products, which occurred at a point in time, typically upon delivery of product to the customers. The Company evaluated the creditworthiness of its customers to determine whether it was probable that a significant reversal in the amount of the cumulative revenue recognized will not occur. The Company did not assess whether a contract had a significant financing component if the expectation was such that the period between the transfer of the promised goods to the customer and the receipt of payment would be less than one year. Standard credit terms did not exceed 75 days. The Company expensed incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that would have been recognized is one year or less or the amount is immaterial. Shipping and handling costs related to the Company’s product sales were included in selling, general and administrative expenses. Product revenue was recorded net of distribution fees, trade discounts, allowances, rebates, copay program coupons, chargebacks, estimated returns and other incentives. These reserves were classified as either reductions of accounts receivable or as current liabilities. The estimates of reserves established for variable consideration reflect contractual and statutory requirements, known market events and trends, industry data and forecasted customer mix. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, was subject to constraint and was included in the net product revenues only to the extent that it was probable that a significant reversal of the amount of the cumulative revenues recognized would not occur in a future period. Product Sales Provisions Provisions for distribution fees, trade discounts and chargebacks are reflected as a reduction to trade receivables, net on the consolidated balance sheet. All other provisions, including rebates, other discounts and return provisions are reflected as a liability within accrued expenses on the consolidated balance sheet. The revenue reserve accrual was $2.3 million and $2.7 million as of December 31, 2023 and December 31, 2022, respectively. Under the terms of the Asset Purchase Agreement, the Company retained and is responsible for historical liabilities of the commercial business operations based on events occurring prior to the sale other than those liabilities expressly assumed by Journey. Distribution Fees and Trade Discounts and Allowances The Company paid fees for distribution services and for certain data that distributors provided to the Company and generally provided discounts on sales to its distributors for prompt payment. These fees and discounts were contractual in nature and the Company expected its distributors to earn these fees and discounts, and accordingly deducted the full amount of these fees and discounts from its gross product revenues at the time such revenues were recognized. Rebates, Chargebacks and Other Discounts Product sales made under managed-care and governmental pricing programs in the United States were subject to rebates. Managed Care rebates related to contractual agreements to sell products to managed care organizations and pharmacy benefit managers at contractual rebate percentages in exchange for volume and/or market share. Chargebacks related to contractual agreements to sell products to government agencies and other indirect customers at contractual prices that are lower than the list prices the Company charges wholesalers. When these government agencies or other indirect customers purchased products through wholesalers at these reduced prices, the wholesaler charged the Company for the difference between the prices they paid the Company and the prices at which they sold the products to the indirect customers. The Company estimated the rebates and chargebacks it expected to be obligated to provide and deducted these estimated amounts from its gross product revenue at the time the revenue was recognized. The Company's estimates were based upon (i) the Company's contracts, (ii) estimates regarding the payor mix based on third-party data and utilization, (iii) inventory held by distributors and (iv) estimates of inventory held at the retail channel. Other discounts included the Company’s co-pay assistance coupon programs for commercially-insured patients meeting certain eligibility requirements. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expected to pay associated with product that had been recognized as revenue. Product Returns Consistent with industry practice, customers were generally allowed to return products within a specified period of time before and after its expiration date. The Company estimated the amount of product that would be returned and deducted these estimated amounts from its gross revenue at the time the revenue was recognized. T he information utilized to estimate the returns provision included: (i) actual return history (ii) historical return industry information regarding rates for comparable pharmaceutical products and product portfolios , (iii) external data with respect to inventory levels in the wholesale distribution channel, (iv) external data with respect to prescription demand for products and (v) remaining shelf lives of products at the date of sale. Contract Assets and Contract Liabilities The Company did not have any contract assets (unbilled receivables) related to product sales as of December 31, 2023 or 2022, as customer invoicing generally occured before or at the time of revenue recognition. The Company did not have any contract assets (unbilled receivables) related to its license revenues as of December 31, 2023 or 2022. The Company did not have any contract liabilities as of December 31, 2023 or 2022, as the Company did not receive payments in advance of fulfilling its performance obligations to its customers. o. Collaboration arrangements The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC Topic 808, Collaborative Arrangements (ASC 808), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company will assess whether aspects of the arrangement between it and their collaboration partner are within the scope of other accounting literature. p. Research and development costs Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of clinical trials, clinical trial supplies, salaries, share-based compensation expenses, payroll taxes and other employee benefits, lab expenses, consumable equipment and consulting fees. All costs associated with research and developments are expensed as incurred. q. Fair value measurement Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data or active market data of similar or identical assets or liabilities. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. r. Income taxes: • Deferred taxes Income taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable future. Given the Company’s losses, the Company has provided a full valuation allowance with respect to its deferred tax assets. • Uncertainty in income tax The Company follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the position will be sustained based on technical merits. If this threshold is met, the second step is to measure the tax position as the largest amount that has more than a 50% likelihood of being realized upon ultimate settlement. s. Net loss per share Net loss per share, basic and diluted, is computed on the basis of the net loss from continuing operations for the period divided by the weighted average number of common shares outstanding during the period. Diluted net loss per share is based upon the weighted average number of common stock and of common stock equivalents outstanding when dilutive. The following stock options, restricted stock units (“RSUs”) and warrants were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented (data presented as numbers of shares): Year ended December 31, 2023 2022 Outstanding stock options and RSUs 1,205,516 313,403 Warrants 27,509 27,509 t. Discontinued Operations The Company accounted for the sale of the MST Franchise in accordance with ASC 205, Discontinued Operations, and ASU No. 2014-08, Reporting of Discontinued Operations and Disclosures of Disposals of Components of an Entity . The Company followed the held-for-sale criteria as defined in ASC 360 Property, Plant and Equipment and ASC 205. ASC 205 requires that a component of an entity that has been disposed of or is classified as held for sale and has operations and cash flows that can be clearly distinguished from the rest of the entity be reported as assets held for sale and discontinued operations. In the period a component of an entity has been disposed of or classified as held for sale, the results of operations for the periods presented are reclassified into separate line items in the consolidated statements of operations. Assets and liabilities are also reclassified into separate line items on the related consolidated balance sheets for the periods presented. Non-cash items presented in the statement of cash flows and related to discontinued operations are presented in Note 4 - Discontinued Operations. ASU 2014-08 requires that only a disposal of a component of an entity, or a group of components of an entity, that represents a strategic shift that has, or will have, a major effect on the reporting entity’s operations and financial results be reported in the consolidated financial statements as discontinued operations. ASU 2014-08 also provides guidance on the financial statement presentations and disclosures of discontinued operations. Due to the sale of the MST Franchise during the first quarter of 2022, in accordance with ASC 205, the Company has classified the results of the MST Franchise as discontinued operations in its consolidated statements of operations and cash flows for all periods presented (see Note 4, Discontinued Operations). All disposed assets and liabilities associated with the MST Franchise were therefore classified as assets and liabilities of discontinued operations in the Company's consolidated balance sheets for the periods presented. All amounts included in the notes to the consolidated financial statements relate to continuing operations unless otherwise noted. u. Concentration of credit risks Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents, restricted cash, marketable securities and accounts receivables. The Company deposits cash and cash equivalents with highly rated financial institutions and, as a matter of policy, limits the amounts of credit exposure to any single financial institution. In addition, all marketable securities carry a high credit rating or are government insured. The Company has not experienced any material credit losses in these accounts and does not believe it is exposed to significant credit risk on these instruments. Existing royalty receivables relate to one customer, but do not present a credit risk due to immaterial nature. Restricted cash as of December 31, 2023 was $0.1 million which does not present a credit risk due to its immaterial nature. v. Employee Retention Tax Credit In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was signed into law, providing numerous tax provisions and other stimulus measures, including employee retention tax credits (“ERTC”). The ERTC was a refundable tax credit against certain employment taxes for qualifying businesses retaining employees on their payroll during the COVID-19 pandemic and allowed eligible employers to claim a refundable tax credit against the employer share of Social Security tax equal to 70% of the qualified wages they paid to employees, initially from March 27, 2020 until June 30, 2021, and extended through September 30, 2021. During 2022, the Company filed returns with the Internal Revenue Service (IRS) and claimed credits totaling $1.3 million. During the first quarter of 2023, the Company received the full $1.3 million. As there is no authoritative guidance under U.S. GAAP on accounting for government assistance to for-profit business entities, the Company has accounted for the ERTC by analogy to International Accounting Standard, Accounting for Government Grants and Disclosure of Government Assistance (“IAS 20”). The ERTC filings remain open to examination by the IRS until April 2025, and as such the Company has recorded the $1.3 million received within other liabilities on the consolidated balance sheet as of December 31, 2023 until such a time that the Company has reasonable assurance that the conditions associated with the grants have been met. w. Warrants The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC Topic 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent reporting period end date while the warrants are outstanding. For issued warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. Liability-classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after the issuance date recorded as a component of other income, net in the statements of operations. As of December 31, 2023 all of the Company's outstanding warrants were equity-classified warrants. x. Newly issued and recently adopted accounting pronouncements : Recent Accounting Guidance Issued: In June 2016, the FASB issued Accounting Standards Update No. 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ” (ASU 2016-13), which requires companies to measure credit losses of financial instruments, including customer accounts receivable and marketable securities, utilizing a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Subsequent to the issuance of ASU 2016-13, the FASB issued several additional Accounting Standard Updates to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance. As a smaller reporting company, the Company adopted ASU 2016-13 effective January 1, 2023, and there was no material impact on the consolidated financial statements upon adoption. In March 2020, the FASB issued Accounting Standards Update No. 2020-04, " Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting " (ASU 2020-04), which provides guidance to alleviate the burden in accounting for reference rate reform by allowing certain expedients and exceptions in applying generally accepted accounting principles to contracts, hedging relationships, and other transactions impacted by reference rate reform. The provisions of ASU 2020-04 apply only to those transactions that reference LIBOR or another reference rate expected to be discontinued due to reference rate reform. Adoption of the provisions of ASU 2020-04 was optional through December 31, 2022. In December 2022, the FASB issued Accounting Standards Update No. 2022-06, " Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848" (ASU 2022-06), which provides extension of the sunset date of Topic 848 from December 31, 2022, to December 31, 2024. The Company is currently evaluating the impact of ASU 2020-04 and ASU 2022-06 on its consolidated financial statements. Currently, the Company does not expect the adoption of the new standard to have a material impact to the consolidated financial statements. In August 2020, the FASB issued ASU No. 2020-06, “ Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ” (“ASU 2020-06”), which simplifies the accounting for convertible instruments by eliminating the requirement to separately account for embedded |
STRATEGIC AGREEMENTS
STRATEGIC AGREEMENTS | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
STRATEGIC AGREEMENTS | STRATEGIC AGREEMENTS Agreements with Tay Therapeutics Evaluation and Option Agreement In April 2021, the Company entered into an Evaluation and Option Agreement (the “Option Agreement”) with Tay. Pursuant to the Option Agreement, Tay granted the Company an exclusive option to obtain certain exclusive worldwide rights to research, develop and commercialize products containing Tay’s BET inhibitor compounds for the treatment of any disease, disorder or condition in humans. Pursuant to the Option Agreement, the Company agreed to use commercially reasonable efforts to stabilize, develop and manufacture a product with a pan-BD BET inhibitor as its active ingredient and Tay agreed to provide a mutually agreed data package and select new chemical entity development candidate from its highly selective BET inhibitor compounds (the "Oral BETi Compounds"). The Company paid a $1.0 million non-refundable cash payment to Tay upon execution of the Option Agreement, 50% of which was to be used by Tay in the development of the Oral BETi Compounds. Under the terms of the Option Agreement, the Company's option (the "Oral Option") with respect to the Oral BETi Compounds was to expire on June 30, 2022 (the "Option Term"), but in June 2022, the Company and Tay entered into a Letter Agreement (the “Letter Agreement”) to extend the Option Term to February 28, 2023. Pursuant to the terms of the Letter Agreement, the Company paid Tay $386,366 (£300,000) on June 28, 2022 to extend the Option Term. In addition, on August 29, 2022, the Company made a second payment to Tay of $997,407 (£850,000) pursuant to the terms of the Letter Agreement following the discovery of potential Oral BETi Compounds for further development. Both payments were recorded as research and development expense. On February 27, 2023, the parties entered into an additional Letter Agreement (the "Second Letter Agreement") pursuant to which the Option Term was extended to April 30, 2023. As consideration for the extension of the Option Term, the Company paid Tay $250,000 upon the execution of the Second Letter Agreement. Per the terms of the Second Letter Agreement, this fee was deducted from the upfront fee paid by the Company to Tay following the Company's exercise of the Oral Option, as described below. License for Locally Administered Pan-BD BET Inhibitor Program (VYN201) On August 6, 2021, the Company exercised its option with respect to the VYN201 program and, on August 9, 2021, the parties entered into a License Agreement (the “VYN201 License Agreement”) granting the Company a worldwide, exclusive license that is sublicensable through multiple tiers to exploit certain of Tay’s pan-BD BET inhibitor compounds in all fields. The Company has the sole responsibility for development, regulatory, marketing and commercialization activities to be conducted for the licensed products at its sole cost and discretion. The Company is required to use commercially reasonable efforts to develop and, if approved, commercialize such products. Pursuant to the VYN201 License Agreement, a joint development committee consisting of one representative from each party reviews the progress of the development plan for the licensed products. Pursuant to the VYN201 License Agreement, the Company may develop a product that contains or incorporates a specific BET inhibitor, whether alone or in combination with other active ingredients, in any form, formulation, presentation, or dosage, and for any mode of administration. The Company made a $0.5 million cash payment to Tay in connection with entering into the VYN201 License Agreement. Pursuant to the VYN201 License Agreement, the Company has agreed to make cash payments to Tay upon the achievement of specified clinical development and regulatory approval milestones with respect to each licensed topical product in the United States of up to $15.75 million for all indications. Tay is entitled to additional milestone payments upon the achievement of regulatory approvals in certain non-U.S. jurisdictions. In addition, with respect to any products the Company commercializes under the VYN201 License Agreement, the Company will pay tiered royalties to Tay on net sales of such licensed products by the Company, its affiliates, or sublicensees, of 5%, 7.5% and 10% based on tiered annual net sales bands subject to specified reductions. The Company is obligated to pay royalties until the latest of (1) the tenth anniversary of the first commercial sale of the relevant licensed product, (2) the expiration of the last valid claim of the licensed patent rights covering such licensed product in such country and (3) the expiration of regulatory exclusivity for the relevant licensed product in the relevant country, on a licensed product-by-licensed product and country-by-country basis. License for Selective BET Inhibitor Program (VYN202) On April 28, 2023, the Company exercised the Oral Option and entered into a license agreement (the "VYN202 License Agreement") with Tay granting the Company a worldwide, exclusive license that is sublicensable through multiple tiers to exploit certain of Tay’s Oral BETi Compounds in all fields. The Company has the sole responsibility for development, regulatory, marketing and commercialization activities to be conducted for the licensed products at the sole cost and discretion of the Company, and shall use commercially reasonable efforts to develop and, if approved, commercialize such products. VYNE may sublicense its rights to a third party without Tay’s consent. Pursuant to the License Agreement, a joint development committee consisting of one representative from each party reviews the progress of the development plan for the licensed products. The Company made a cash payment of $3.75 million, after deducting the $250,000 paid in February 2023, to Tay in connection with entering into the VYN202 License Agreement. This payment was recorded as a research and development expense in the period paid. Pursuant to the terms of the VYN202 License Agreement, the Company agreed to make cash payments to Tay of up to $43.75 million upon the achievement of specified clinical development and regulatory approval milestones with respect to each licensed oral product in the United States for all indications. Tay is entitled to additional milestone payments upon the achievement of regulatory approvals in certain non-U.S. jurisdictions. In addition, with respect to any products the Company commercializes under the VYN202 License Agreement, the Company will pay tiered royalties to Tay on net sales of such licensed products by the Company, its affiliates, or sublicensees, of 5%, 7.5% and 10% based on tiered annual net sales bands subject to specified reductions. The Company is obligated to pay royalties until the latest of (1) the tenth anniversary of the first commercial sale of the relevant licensed product, (2) the expiration of the last valid claim of the licensed patent rights covering such licensed product in such country and (3) the expiration of regulatory exclusivity for the relevant licensed product in the relevant country, on a licensed product-by-licensed product and country-by-country basis. Sale of the MST Franchise On January 12, 2022, VYNE entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Journey Medical Corporation (“Journey”) pursuant to which the Company sold its Molecule Stabilizing Technology franchise, including AMZEEQ, ZILXI, and FCD105 (referred to collectively as the “MST Franchise”), to Journey. The assets included certain contracts, including the license agreement with Cutia Therapeutics (HK) Limited (“Cutia”), inventory and intellectual property related to the MST Franchise (together, the “Assets”). Pursuant to the Agreement, Journey assumed certain liabilities of the MST Franchise. There were no current or long-term liabilities recorded by the Company which were transferred to Journey. |
DISCONTINUED OPERATIONS
DISCONTINUED OPERATIONS | 12 Months Ended |
Dec. 31, 2023 | |
Discontinued Operations and Disposal Groups [Abstract] | |
DISCONTINUED OPERATIONS | DISCONTINUED OPERATIONS The Company determined that the sale of the MST Franchise represented a strategic shift that had a major effect on the business and therefore the MST Franchise met the criteria for classification as discontinued operations. Accordingly the MST Franchise is reported as discontinued operations in accordance with ASC 205-20, Discontinued Operations . The Company recognized a gain on the sale of the MST Franchise upon closing. The negative product sales for the years ended December 31, 2023 and 2022 were primarily attributable to a change in the product returns provision following the sale of the MST Franchise. The following table presents the combined results of discontinued operations of the MST Franchise: Year ended December 31, (in thousands) 2023 2022 Product sales, net $ (525) $ (1,844) Cost of goods sold — 80 Operating expenses: Selling, general and administrative 55 259 Total operating expenses 55 259 Loss from discontinued operations (580) (2,183) Gain on the sale of the MST Franchise — 12,918 Income (loss) from discontinued operations, before income taxes (580) 10,735 Income tax expense — — Net income (loss) from discontinued operations $ (580) $ 10,735 The following table presents non-cash items related to discontinued operations, which are included in the Company's consolidated statement of cash flows for the year ended December 31, 2022: Year ended December 31, (in thousands) 2022 Cash Flows From Operating Activities: Stock-based compensation (income) expense* $ (352) Gain on the sale of the MST Franchise (12,918) Total non-cash items of discontinued operations $ (13,270) Supplemental disclosure of cash flow information: Amount due from sale of MST Franchise $ 5,000 *Income from stock-based compensation is related to forfeitures. There were no non-cash items related to discontinued operations for the year ended December 31, 2023. The following table presents the gain on the sale of the MST Franchise: (in thousands) Year ended December 31, 2022 Cash proceeds 20,000 Proceeds received in January 2023 5,000 25,000 Less transaction costs (4,334) Less carrying value of assets sold (7,748) Gain on sale, before income taxes 12,918 Income tax expense — Gain on sale net of tax $ 12,918 In accordance with ASC 205-20, only expenses specifically identifiable and related to a business to be disposed may be presented in discontinued operations. As such, the research and development, marketing, selling and general and administrative expenses in discontinued operations include corporate costs incurred directly to solely support the MST Franchise. The potential milestone payments for sales of ZILXI, AMZEEQ and FCD105 represent contingent consideration. Contingent consideration has been accounted for as a gain contingency in accordance with ASC 450, Contingencies , and will be recognized in earnings in the period when realizable. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS The Company’s financial assets that are measured at fair value as of December 31, 2023 are classified in the tables below in one of the three categories described in "Note 2(q) - Fair value measurement" above: December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents $ 20,353 $ 10,267 $ — $ 30,620 Marketable securities — 62,633 — 62,633 Total assets $ 20,353 $ 72,900 $ — $ 93,253 As of December 31, 2022, the Company had $28.0 million of cash equivalents classified as Level 1 financial instruments and no marketable securities. Other financial instruments consist of trade receivables, trade payables and accrued expenses. The fair value of these financial instruments approximates their carrying values due to their short-term nature. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | MARKETABLE SECURITIES Marketable securities as of December 31, 2023 consisted of U.S Government and agency bonds as well as U.S Treasury bills. The Company did not hold any marketable securities as of December 31, 2022. The following tables sets forth the Company’s marketable securities: December 31, (in thousands) 2023 U.S. Government and agency bonds $ 31,886 U.S. Treasury bills 30,747 Total $ 62,633 As of December 31, 2023, the fair value, amortized cost, gross unrealized gains, and gross unrealized losses were as follows: December 31, 2023 (in thousands) Amortized Gross Unrealized Gain Gross Unrealized Fair U.S Government and agency bonds 31,866 30 (10) 31,886 U.S Treasury bills 30,742 5 — 30,747 Total $ 62,608 $ 35 $ (10) $ 62,633 As of December 31, 2023, $62.6 million of the marketable securities were in an unrealized gain position. The Company determined that unrealized gains and losses on marketable securities were primarily due to interest rate changes. No allowance for credit losses related to any of these securities was recorded for the year ended December 31, 2023. All maturities are less than 12 months. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | PROPERTY AND EQUIPMENT During the year ended December 31, 2022, the Company disposed of fixed assets in the net amount of $0.3 million. Loss on disposal of fixed assets during the year ended December 31, 2022 related to the write-off of laboratory and leasehold improvements due to a reduction in office space in Israel and the United States and is reflected within operating expenses on the consolidated statements of operations. Depreciation expense totaled zero and $0.1 million for the years ended December 31, 2023 and 2022, respectively. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | ACCRUED EXPENSES Accrued expenses consisted of the following: December 31, 2023 2022 Product sales provisions $ 2,250 $ 2,695 Research and development 990 987 Professional services 648 519 Other 231 180 Total Accrued Expenses $ 4,119 $ 4,381 |
OPERATING LEASE
OPERATING LEASE | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
OPERATING LEASE | OPERATING LEASE As of December 31, 2023, the Company had an operating lease for its principal executive office in Bridgewater, New Jersey. On March 13, 2019, the Company signed an amendment to the original lease agreement for its principal executive office in Bridgewater, New Jersey (the “Lease Amendment”). The Lease Amendment included an extension of the lease period of the 10,000 square feet previously leased under the original agreement (the “Original Space”) and an addition of 4,639 square feet (the “Additional Space”). The Company entered the Additional Space following a period of preparation by the lessor completed during September 2019 (the “Commencement Date”). The term included in the Lease Amendment expired on September 30, 2022. Pursuant to the Lease Amendment, the Company recognized an additional right of use asset and liability in the amount of $0.7 million. The Additional Space was considered a new lease agreement and was recognized as a right of use asset and liability, in the amount of $0.3 million, on the Commencement Date. The lease liability matured on September 30, 2022. In November 2022, the Company transitioned to a smaller corporate headquarters and signed a Sublease Agreement (the “Sublease”) to sublease approximately 5,755 square feet of office space (the “Leased Premises”) in Bridgewater, New Jersey through September 30, 2023. In addition, the Company signed a Lease Agreement (the “Master Lease”) to lease the Leased Premises following the termination of the Sublease through September 30, 2025. The Company recorded a right of use asset of $0.2 million and liability of $0.3 million at the commencement date of the Master Lease on October 1, 2023. The Company's lease agreement for its former office space in Israel was a one year lease that expired in December 2022. Given the short-term nature of the lease term, the Company did not recognize a right-of-use asset or liability. The components of lease expense are as follows: (in thousands) Year Ended December 31, 2023 Year Ended December 31, 2022 Operating lease expense $ 32 $ 271 Short-term lease expense $ 86 $ 217 Variable lease expense $ (16) $ 69 Total lease expense $ 102 $ 557 Variable lease expense primarily consists of utility and other common area maintenance ("CAM") charges. For the year ended December 31, 2023 the variable lease expenses included a reversal of expense related to CAM charges. Lease expense is included within general and administrative expenses on the consolidated statements of operations. Operating cash flows for amounts included in the measurement of lease liabilities are as follows: Year Ended December 31, 2023 Operating leases $ 25 Supplemental information related to leases are as follows: December 31, 2023 Operating lease right-of-use assets $ 207 Operating lease liabilities $ 214 Weighted average remaining lease term 1.75 Weighted average discount rate 8.00 % There were no right-of-use assets or lease liabilities as of December 31, 2022. Maturities of lease liabilities are as follows: 2024 $ 126 2025 102 Total lease payments 228 Less imputed interest (14) Total lease liability $ 214 Current operating lease liabilities 115 Non-current operating lease liabilities 99 Total lease liability $ 214 |
EMPLOYEE SAVINGS PLAN
EMPLOYEE SAVINGS PLAN | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
EMPLOYEE SAVINGS PLAN | EMPLOYEE SAVINGS PLANThe Company makes retirement savings plans available to all of its employees and those of its subsidiary, which are intended to qualify as deferred compensation plans under Section 401(k) of the Internal Revenue Code (the “401(k) Plans”). The Company made contributions to these 401(k) Plans during the years ended December 31, 2023 and 2022 of $0.1 million in each period. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Litigation and contingencies |
MEZZANINE AND SHAREHOLDERS' EQU
MEZZANINE AND SHAREHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
MEZZANINE AND SHAREHOLDERS' EQUITY | MEZZANINE AND SHAREHOLDERS' EQUITY Preferred stock As of December 31, 2023, the Company's Amended and Restated Certificate of Incorporation (as amended, the "Certificate of Incorporation") authorized the Company to issue 20,000,000 shares of preferred stock, par value $0.0001 per share. There wer e zero and 3,000 shares of Series A Convertible Preferred Stock issued and outstanding as of December 31, 2023 and December 31, 2022, respectively. Shares of preferred stock may be issued from time to time in one or more series. The voting powers (if any), preferences and relative, participating, optional or other special rights, and the qualifications, limitations and restrictions of any series of preferred stock will be set forth in a Certificate of Designation filed pursuant to the Delaware General Corporation Law, as determined by the Company's Board of Directors. On November 11, 2022, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with Mutual Fund Series Trust, on behalf of AlphaCentric LifeSci Healthcare Fund (the “Purchaser”), pursuant to which the Company issued on November 14, 2022, in a private placement transaction, an aggregate of 3,000 shares of Series A Convertible Preferred Stock, par value $0.0001 per share (the “Series A Preferred”), for an aggregate subscription amount equal to $300,000. This transaction resulted in $89,000 of issuance costs and net proceeds of $211,000 . The Company determined that the Series A Preferred should be classified as Mezzanine Equity (temporary equity outside of permanent equity), because the Series A Preferred more closely aligned with debt as the intent was for redemption by either the holder or the Company due to the favorable redemption terms. The Purchase Agreement required that the Company convene a meeting of stockholders for the purpose of presenting to the Company’s stockholders a proposal (the “Proposal”) authorizing the Company's board of directors to approve a reverse stock split of its outstanding Common Stock, with the recommendation of the board of directors that the Proposal be approved, and that the Company use reasonable best efforts to obtain approval of the Proposal. The meeting was convened on January 12, 2023, and the Proposal was approved. Additionally, the Purchase Agreement contained customary representations, warranties and agreements of the Company and the Purchaser, and customary indemnification rights and obligations of the parties. Pursuant to the Purchase Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A Co nvertible Preferred Stock (the “Certificate of Designation”) with the Secretary of State of Delaware on November 14, 2022 designating 3,000 shares out of the authorized but unissued shares of its preferred stock as Series A Preferred with a par value of $0.0001 per share and establishing the rights, preferences and limitations of the Series A Preferred. The Certificate of Designation prov ided, among other things, that except as otherwise provided in the Certificate of Designation or as otherwise required by law, the Series A Preferred would have no voting rights (other than the right to vote as a class on certain matters as provided in the Certificate of Designation). However, pursuant to the Certificate of Designation, each share of Series A Preferred entitled the holder thereof (i) to vote on the Proposal and any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Proposal, and (ii) to 1,000,000 votes per share of Series A Preferred on the Proposal and any such adjournment proposal. The Series A Preferred should, except as required by law, vote together with the common stock (and other issued and outstanding shares of preferred stock entitled to vote), as a single class; provided, however, that such shares of Series A Preferred should, to the extent cast on the Proposal or any such adjournment proposal, be automatically and without further action of the holders thereof voted in the same proportion as the shares of common stock (excluding abstentions and any shares of common stock that are not voted) and any other issued and outstanding shares of preferred stock of the Company entitled to vote (other than the Series A Preferred or shares of such other preferred stock, if any, not voted) are voted on the Proposal. In addition, the Series A Preferred were entitled to customary dividends and distributions when and if paid on shares of the common stock and were entitled to the voting rights discussed above. The Series A Preferred had preference over the common stock with respect to distribution of assets or available proceeds, as applicable, in the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company or any other deemed liquidation event. The shares of Series A Preferred were convertible at the option of the holder, at a conversion price of $4.68 per share (as adjusted for the reverse stock split), into shares of the Company’s common stock, at any time and from time to time from and after 15 business days following the earlier of (i) the date of the approval of the Proposal or (ii) the date the Company otherwise satisfied the Nasdaq listing requirements. The Company had the right to redeem the Series A Preferred at any time during the 15 business days following the approval of the Proposal (the "Company Redemption Period") at 120% of the stated value. Each holder of Series A Preferred had the right to require the Company to redeem all or a portion of the Series A Preferred held by such holder following the expiration of the Company Redemption Period at 130% of the stated value. In addition, the Company would automatically redeem all of the Series A Preferred within five business days following a delisting event as specified in the Certificate of Designation at 130% of the stated value. On January 17, 2023, the Company redeemed all outstanding shares of its Series A Preferred, for an aggregate of $360,000 paid to the sole holder of the Series A Preferred. The redemption payment represented 120% of the stated value of the Series A Preferred Stock pursuant to the Certificate of Designation. On January 17, 2023, the Company filed a Certificate of Elimination (the “Certificate”) with the Secretary of State of the State of Delaware with respect to the Series A Preferred. The Certificate (i) eliminated the previous designation of 3,000 shares of Series A Preferred from the Company’s Amended and Restated Certificate of Incorporation, none of which were outstanding at the time of filing, and (ii) caused such shares of Series A Preferred to resume their status as authorized but unissued and non-designated shares of preferred stock. Common stock Pursuant to the Certificate of Incorporation, the Company is authorized to issue 150,000,000 shares of common stock, par value $0.0001 per share. Each share of common stock is entitled to one v ote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when and if declared by the board of directors, subject to the prior rights of holders of all classes of preferred stock outstanding. The Company has never declared any dividends on common stock. On February 8, 2023, the Company's Board of Directors approved a 1-for-18 reverse stock split of the Company's outstanding shares of common stock. The reverse stock split was effected on February 10, 2023 at 5:01 p.m. Eastern time. At the effective time, every 18 issued and outstanding shares of the Company's common stock were converted into one share of common stock. No fractional shares were issued in connection with the reverse stock split, and in lieu thereof, each stockholder holding fractional shares was entitled to receive a cash payment (without interest or deduction) in an amount equal to such stockholder’s respective pro rata share of the total net proceeds from the Company’s transfer agent's sale of all fractional shares at the then-prevailing prices on the open market. The number of authorized shares of the Company's common stock and the par value of each share of common stock remained unchanged. Unless noted, all common shares and per share amounts contained in the consolidated financial statements have been retroactively adjusted to reflect the 1-for-18 reverse stock split. The Company had reserved shares of common stock for future issuance as follows: Year ended December 31, 2023 Shares underlying outstanding pre-funded warrants 28,482,594 Shares available for future grant under 2023 Plan (Note 13) 1,129,856 Common stock options outstanding (Note 13) 744,537 Outstanding restricted stock units (Note 13) 460,979 Shares available for grant under the Employee Stock Purchase Plan (Note 13) 101,202 Shares underlying other outstanding warrants 27,509 30,946,677 Issuance of stock At-the-Market Equity Offering Programs On August 12, 2021, the Company entered into a sales agreement (the "Cantor Sales Agreement") with Cantor Fitzgerald to sell shares of the Company's common stock, from time to time, with aggregate gross sales proceeds of up to $50.0 million through an at-the-market equity offering program under which Cantor Fitzgerald would act as the Company's sales agent. Cantor Fitzgerald was entitled to compensation for its services equal to up to 3.0% of the gross proceeds of any shares of common stock sold under the Cantor Sales Agreement. During the year ended December 31, 2022, the Company issued and sold 143,770 shares of common stock at a weighted average per share price of $11.16 pursuant to the Cantor Sales Agreement for $1.5 million in net proceeds. During the year ended December 31, 2023, the Company issued and sold 34,589 shares of common stock at a weighted average per share price of $4.66 pursuant to the Cantor Sales Agreement for $0.2 million in net proceeds. On February 27, 2024, the Company delivered notice to Cantor Fitzgerald to terminate the Cantor Sales Agreement. The Company cannot make any future sales of its common stock pursuant to the Cantor Sales Agreement. On March 1, 2024, the Company entered into a Sales Agreement (the “Cowen Sales Agreement”) with Cowen and Company, LLC, as sales agent (“Cowen”) under which the Company may offer and sell, from time to time at its sole discretion, shares of the Company's common stock through Cowen in an at-the-market offering having an aggregate offering price up to $50.0 million. Cowen is entitled to compensation for its services equal to 3.0% of the gross proceeds of any shares of common stock sold under the Cowen Sales Agreement. Sales pursuant to the Cowen Sales Agreement may only take place once the Registration Statement on Form S-3, of which the prospectus for such sales forms a part, is filed and declared effective by the Securities and Exchange Commission. Equity Line of Credit On March 15, 2022, the Company entered into a purchase agreement (the "Equity Purchase Agreement") with Lincoln Park Capital ("Lincoln Park") which provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company could sell to Lincoln Park, at the Company's discretion, up to $30.0 million of shares of its common stock over the 36-month term of the Equity Purchase Agreement. Upon execution of the Equity Purchase Agreement, the Company issued 92,644 shares of its common stock to Lincoln Park as commitment shares in accordance with the closing conditions contained within the Equity Purchase Agreement. The issuance of these shares were specific incremental costs directly attributable to the proposed offering. The commitment shares were valued at $0.9 million and recorded as an addition to equity for the issuance of common stock and treated as a reduction to equity as a cost of capital to be raised under the Equity Purchase Agreement. The Equity Purchase Agreement could be terminated by the Company at any time, at its sole discretion, without any additional cost or penalty. On October 30, 2023, the Company delivered notice to Lincoln Park terminating the Equity Purchase Agreement. Private Placement On October 27, 2023, the Company entered into the Securities Purchase Agreement, pursu ant to which the Company agreed to sell and issue to the Purchasers in the Private Placement (i) 10,652,543 shares of the Company’s common stock and (ii) with respect to certain Purchasers, Pre-Funded Warrants to purchase 28,614,437 shares of common stock in lieu of shares. The Stock Purchase Price of common stock was $2.245 per share and the purchase price for the Pre-Funded Warrants was the Stock Purchase Price minus $0.0001 per Pre-Funded Warrant. On November 1, 2023, the Company received gross proceeds of $88.2 million from the Private Placement. This transaction resulted in $5.5 million of issuance costs and net proceeds of $82.7 million as of December 31, 2023 . The Company expects to use the proceeds from the Private Placement to advance its clinical programs and for general corporate purposes. Pre-Funded Warrants The Pre-Funded Warr ants issued in the Private Placement will not expire until exercised in full. The Pre-Funded Warrants may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation; provided, however, that a holder may increase or decrease the beneficial ownership limitation by giving 60 days’ notice to the Company, but not to exceed any percentage in excess of 19.99%. As of December 31, 2023, 28,482,594 Pre-Funded Warrants remained outstanding. Between the issuance and December 31, 2023, 131,838 Pre-Funded Warrants were exercised. Other Warrants As of December 31, 2023 and December 31, 2022, the Company had warrants to purchase an aggregate of 27,509 shares of the Company’s common stock outstanding, with exercise prices of $8.40 and $76.78 as of December 31, 2023 and 2022, respectively, and an expiration date of July 29, 2026. These warrants were issued by Foamix (as defined below) in connection with a financing in July 2019 and were subsequently assumed by the Company in connection with the Merger (as defined below). Pursuant to the warrant certificate, the exercise price of the warrant will be proportionally adjusted in the event that the Company distributes common stock at a price per share less than the exercise price (the "Down Round Feature"). During the years ended December 31, 2023 and 2022, the Down Round Feature was triggered due to the price per share received from the issuances of common stock. The Company calculated the value of the effect of Down Round Feature measured as the difference between the warrants’ fair value, using the Black-Scholes-Merton option-pricing model, before and after the Down Round Feature was triggered using the original exercise price and the new exercise price. The difference in fair value of the effect of the Down Round Feature was immaterial and had an immaterial impact on net loss per share in the periods presented. The exercise price will continue to be adjusted in the event the Company issues additional shares of common stock below the current exercise price, in accordance with the terms of the warrants. The Pre-Funded Warrants and Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the Pre-Funded Warrants and Warrants do not provide any guarantee of value or return. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
SHARE-BASED COMPENSATION | SHARE-BASED COMPENSATION 2023 Equity Incentive Plan: On December 13, 2023, the Company's stockholders approved the Company's 2023 Equity Incentive Plan (the "2023 Plan"). The Company previously maintained the 2019 Equity Incentive Plan (the “2019 Plan”) and 2018 Omnibus Incentive Plan (the "2018 Plan"). Following stockholder approval, any shares then available for future grant under the 2019 Plan and 2018 Plan were allocated to the 2023 Plan. As of December 31, 2023, 1,129,856 shares remained issuable under the 2023 Plan, and no further grants will be made under the 2018 Plan or 2019 Plan. 2024 Inducement Plan On February 28, 2024, the Board approved the Company's 2024 Inducement Plan (the "Inducement Plan"). Pursuant to the Inducement Plan and Nasdaq Listing Rule 5635(c)(4), the Company is permitted to grant equity awards as an inducement material to an individual's entering into employment with the Company, subject to certain conditions ("Inducement Grants"). As of February 28, 2024, there were 500,000 shares available for future Inducement Grants. 2019 Employee Share Purchase Plan: The Company has adopted an Employee Share Purchase Plan ("ESPP") pursuant to which qualified employees (as defined in the ESPP) may elect to purchase designated shares of the Company’s common stock at a price equal to 85% of the lesser of the fair market value of the common stock at the beginning or end of each semi-annual share purchase period (“Purchase Period”). Employees are permitted to purchase the number of shares purchasable with up to 15% of the earnings paid (as such term is defined in the ESPP) to each of the participating employees during the Purchase Period, subject to certain limitations under Section 423 of the U.S. Internal Revenue Code. As of December 31, 2023, 101,202 shares remained available for grant under the ESPP. During the years ended December 31, 2023 and 2022, 15,261 a nd 7,549 shares were issued to employees pursuant to the ESPP, respectively. Options and Restricted Stock Units ("RSUs") granted to employees and directors: In the years ended December 31, 2023 and 2022, the Company granted options and RSUs to employees and directors as follows: Year ended December 31, 2023 Award amount Exercise price range Vesting period Expiration Options 535,000 $2.70 1 year - 4 years 10 years RSUs 435,000 — 4 years — Year ended December 31, 2022 Award amount Exercise price range Vesting period Expiration Options 48,861 $5.62- $10.98 1 year - 4 years 10 years RSUs 40,339 — 4 years — The fair value of options and RSUs granted to employees and directors during 2023 and 2022 was $2.4 million and $0.8 million, respectively. One share of common stock will be issued upon settlement of each RSU that vests. The fair value of RSUs granted to employees and directors is based on the share price on grant date. The fair value of each option granted is estimated using the Black-Scholes option pricing method. The volatility is based on a combination of historical volatilities of companies in comparable stages as well as companies in the industry, by statistical analysis of daily share pricing model. The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the options granted in dollar terms. The Company’s management uses the expected term of each option as its expected life. The expected term of the options granted represents the period of time that granted options are expected to remain outstanding and is based on the simplified method. Under the simplified method, the expected life of an option is presumed to be the midpoint between the vesting date and the end of the contractual term. The Company used the simplified method due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected life of the stock options. The underlying data used for computing the fair value of the options are as follows: Year ended December 31, 2023 2022 Fair value of stock option $2.18 - $2.23 $3.55 - $7.49 Dividend yield 0 % 0 % Expected volatility 104.42% - 105.64% 73.70% - 74.40% Risk-free interest rate 4.04% 2.20% - 2.92% Expected term 6 years 6 years Modification of share-based compensation: On November 10, 2019, Menlo Therapeutics Inc. ("Menlo") entered into a merger agreement (the "Merger Agreement") with Foamix Pharmaceuticals Ltd. ("Foamix") and Giants Merger Subsidiary Ltd., a wholly-owned subsidiary of Menlo ("Merger Sub"). On March 9, 2020, Merger Sub merged with and into Foamix, with Foamix surviving as a wholly-owned subsidiary of Menlo (the "Merger"). The combined company changed its name to VYNE in September 2020. Pursuant to the Merger, all outstanding options and RSUs granted by Foamix were exchanged for stock options and RSUs of Menlo’s common stock according to the exchange ratio set forth in the Merger Agreement. In addition, for each option and RSU the holder received a contingent stock right ("CSR"). This transaction was considered to be a modification under ASC 718, Compensation - Stock Compensation. The modification did not affect the remaining requisite service period. As a result of the modification, for outstanding options and RSUs granted to Foamix employees and consultants, the Company recorded immaterial incremental compensation expense. On April 6, 2020, pursuant to the terms of the agreement governing the CSRs, each CSR was converted into 1.2082 shares of Menlo common stock, resulting in an effective exchange ratio in the Merger of 1.8006 shares of Menlo common stock for each Foamix ordinary share. As a result of the modification, for outstanding options and RSUs granted to Foamix employees and consultants, the Company recorded incremental compensation expense of $46 thousand and $0.2 million for the years ended December 31, 2023 and December 31, 2022, respectively. As of December 31, 2023 there is an immaterial amount of unrecognized incremental compensation expense related to the modification which will be amortized using a graded vesting method over the next year. Summary of outstanding and exercisable options and RSUs: The following table summarizes stock option activity for the year ended December 31, 2023: Number of options Weighted Average Exercise Price Outstanding at December 31, 2022 229,787 $ 138.92 Granted 535,000 2.70 Forfeited (4,127) 72.81 Expired (16,123) 173.42 Outstanding at December 31, 2023 744,537 $ 40.65 Exercisable at December 31, 2023 176,688 $ 151.47 The weighted average remaining contractual term of outstanding and exercisable options as of December 31, 2023 was 8.85 years and 5.74 years, respectively. Total unrecognized share-based compensation for options at December 31, 2023 was $2.3 million, which is expected to be recognized over a weighted average period of 3.13 years. There was no intrinsic value of outstanding and exercisable options as of December 31, 2023 The following table summarizes RSU activity for the year ended December 31, 2023: Number of RSUs Weighted Average Grant Date Outstanding at December 31, 2022 83,616 $ 43.30 Awarded 435,000 2.70 Vested (53,845) 42.79 Forfeited (3,792) 49.88 Outstanding at December 31, 2023 460,979 $ 4.99 The weighted average remaining contractual term of outstanding RSUs as of December 31, 2023 was 2.16 years. Total unrecognized compensation expense related to the unvested portion of the RSUs at December 31, 2023 was $2.3 million , which is expected to be recognized over a weighted average period of 3.88 years. Share-based compensation expenses: The following table illustrates the allocation of share-based compensation within the line items on the statements of operations: Year ended December 31, 2023 2022 Research and development expenses 534 1,230 General and administrative expenses 2,771 3,419 Discontinued Operations* — (352) 3,305 4,297 *Income from stock-based compensation is related to forfeitures. |
INCOME TAX
INCOME TAX | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAX | INCOME TAX: The loss before income taxes and the related tax (benefit) expense is as follows: Year ended December 31, (in thousands) 2023 2022 Income (loss) before income taxes: Domestic $ (28,459) $ (23,472) Foreign 7 279 Total loss before taxes $ (28,452) $ (23,193) Current taxes: Federal $ (123) $ — State 2 13 Foreign 121 — Total current taxes $ — $ 13 A reconciliation of income taxes at the U.S. federal statutory rate to the provision for income taxes is as follows: Year ended December 31, 2023 2022 Federal income tax provision at statutory rate 21.00 % 21.00 % State income tax provision, net of federal benefit (0.01) % (0.04) % Permanent differences (0.57) % (1.52) % Change in valuation allowances (20.42) % (19.49) % Other — % — % Effective income tax rate — % (0.05) % The income tax expense for the years ended December 31, 2023 and 2022 differed from the amounts computed by applying the U.S. federal income tax rate of 21% to loss before tax expense as a result of nondeductible expenses, changes in state effective tax rates, foreign taxes, tax credits generated, true up of net operating loss carryforwards, and increase in the Company’s valuation allowance. The Company applies the elements of ASC 740-10 regarding accounting for uncertainty in income taxes. This clarifies the accounting for uncertainty in income taxes recognized in financial statements and required impact of a tax position to be recognized in the financial statements if that position is more likely than not of being sustained by the taxing authority. Included in Other Liabilities on the consolidated balance sheets are the total amount of unrecognized tax benefits of approximately $2.5 million and $2.9 million as of December 31, 2023 and 2022, respectively, net of the federal benefit, which is offset by a valuation allowance. The Company’s policy is to recognize interest and penalties related to tax matters within the income tax provision. Tax years beginning in 2019 are generally subject to examination by taxing authorities, although net operating losses from all years are subject to examinations and adjustments for at least three years following the year in which the attributes are used. The significant components of the Company's deferred tax assets and liabilities are as follows: December 31, (in thousands) 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 72,508 $ 72,903 Tax credit carryforwards 6,851 7,794 Section 174 expenses 7,775 3,529 Share-based compensation 1,988 2,061 Accrued expenses and other 651 586 Total gross deferred tax assets 89,773 86,873 Less - valuation allowance (89,773) (86,873) Total deferred tax assets, net of valuation allowance $ — $ — Deferred tax liabilities: Other — — Right of use assets — — Total gross deferred tax liabilities — — Net deferred tax assets $ — $ — Realization of deferred tax assets is contingent upon sufficient future taxable income during the period that deductible temporary differences and carry forward losses are expected to be available to reduce taxable income. As the achievement of required future taxable income is not likely, the Company recorded a full valuation allowance. At December 31, 2023 and 2022, the Company recorded a valuation allowance against its net deferred tax assets of $89.8 million and $86.9 million, respectively. The change in the valuation allowance during the years ended December 31, 2023 and 2022 was an increase of $2.9 million and $1.3 million, resp ectively. A valuation allowance has been recorded since, in the judgment of management, these assets are not more likely than not to be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during periods in which those temporary differences and carryforwards become deductible or are utilized. As of December 31, 2023, the Company had federal and state net operating loss carryforwards of $331.1 million and $41.7 million, respectively, of which $44.3 million will begin to expire in 2031 for federal and $21.3 million will begin to expire in 2040 for state purposes. As of December 31, 2023, the Company had federal research and development tax credit carryforwards of $6.9 million which will begin to expire in 2031. The Company has no state research and development tax credit carryforwards. As a result of U.S. tax reform legislation, federal net operating losses generated beginning in 2018 and subsequent years carryforward indefinitely, however, the Company has federal net operating losses that pre-date U.S. tax reform legislation which begin to expire in 2031 and federal credit carryforwards that begin to expire in 2031. State net operating loss carryforwards begin to expire in 2031, and the state credit carryforwards began to expire in 2031. Sections 382 and 383 of the Internal Revenue Code of 1986 subject the future utilization of net operating losses and certain other tax attributes, such as research and development tax credits, to an annual limitation in the event of certain ownership changes, as defined. The Company has not completed a 382 study through December 31, 2023, however, it may have experienced ownership changes in the past, including in connection with the Merger. In addition, the Private Placement likely resulted in an ownership change for purposes of Section 382 and therefore t he Company may be materially limited in the amount of NOL and R&D tax credit available for utilization in the future. The Company generated research and development tax credits but has not conducted a study to document the qualified activities. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed and any adjustment is known, a partial reserve has been presented as an uncertain tax position which is offset against the gross research and development deferred tax asset. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforwards and the valuation allowance. Uncertain tax positions: ASC No. 740, Income Taxes, requires significant judgment in determining what constitutes an individual tax position as well as assessing the outcome of each tax position. Changes in judgment as to recognition or measurement of tax positions can materially affect the estimate of the effective tax rate and consequently, affect the operating results of the Company. The following table summarizes the activity of the Company's unrecognized tax benefits (in thousands): Balance at January 1, 2022 $ 2,799 Additions for prior year positions — Additions for current year positions 55 Reductions related to expiration of statute of limitations — Balance at December 31, 2022 $ 2,854 Additions for prior year positions 19 Additions for current year positions 105 Reductions related to expiration of statute of limitations (520) Balance at December 31, 2023 $ 2,458 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation |
Principles of consolidation | b. Principles of consolidation The consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been eliminated upon consolidation. |
Use of estimates | Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. Significant items subject to such estimates and assumptions include product returns and research and development accruals. Actual results could differ from the Company’s estimates. |
Foreign Currency Translation | Foreign Currency Translation Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items in the statements of operations (indicated below), the following exchange rates are used: (i) for transactions - exchange rates at transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation and amortization, etc.) - historical exchange rates. Currency transaction gains and losses are presented in financial income or expenses, as appropriate. |
Cash and cash equivalents | Cash and cash equivalents |
Restricted cash | Restricted Cash As of December 31, 2023 and 2022, the Company had restricted cash of $0.1 million representing bank guarantees. |
Marketable securities | Marketable securities Marketable securities with original maturities of greater than three months and remaining maturities of less than one year from the balance sheet date are classified as short-term. Marketable securities with remaining maturities of greater than one year from the balance sheet date are classified as long-term. The Company classifies all marketable securities as available-for-sale debt securities. The Company’s marketable securities are measured and reported at fair value using either quoted prices in active markets for identical securities or quoted prices in markets that are not active for identical or similar securities. Unrealized gains and losses are reported as a separate component of shareholders’ equity. The cost of securities sold is determined on a specific identification basis, and realized gains and losses, if any, are included in other income, net within the consolidated statement of operations and comprehensive loss. |
Property and equipment | Property and equipment 1) Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2) The Company’s property and equipment are depreciated by the straight-line method on the basis of their estimated useful life. Leasehold improvements are amortized by the straight-line method over the expected lease term, which is shorter than the estimated useful life of the improvements. |
Impairment of long-lived assets | Impairment of long-lived assets The Company tests long-lived assets for impair ment whenever events or circumstances present an indication of impairment. If the sum of expected future cash flows (undiscounted and without interest charges) of the assets is less than the carrying amount |
Credit losses | Credit losses An allowance is maintained for potential credit losses in accordance with accounting standards update ("ASU") No. 2016-13. The Company evaluates its allowance based on expected losses rather than incurred losses, which is known as the current expected credit loss (“CECL”) model. The allowance is determined using the loss rate approach and is measured on a collective (pool) basis when similar risk characteristics exist. Where financial instruments do not share risk characteristics, they are evaluated on an individual basis. The allowance is based on relevant available information, from internal and external sources, relating to past events, current conditions, and reasonable and supportable forecasts.. T |
Leases | Leases The Company's lease portfolio mainly consists of office space. Leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. Operating lease assets represent the Company’s right to use an underlying asset for the lease term whereas lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Leases with an initial term of 12 months or less are not recorded on the consolidated balance sheet. Operating lease expense is recognized on a straight-line basis over the expected lease term. |
Contingencies | Contingencies Certain conditions may exist as of the date of the consolidated financial statements, which may result in a loss to the Company, but which will only be resolved when one or more future events occur or fail to occur. The Company’s management assesses such contingent liabilities and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company’s management evaluates the perceived merits of any legal proceedings or unasserted claims as well as the perceived merits of the amount of relief sought or expected to be sought. Management applies the guidance in ASC 450-20-25 when assessing losses resulting from contingencies. If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability is recorded as accrued expenses in the Company’s financial statements. If the assessment indicates that a potential material loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, then the nature of the contingent liability, together with an estimate of the range of possible loss if determinable and material are disclosed. Loss contingencies considered to be remote by management are generally not disclosed unless they involve guarantees, in which case the guarantees are disclosed. |
Share-based compensation | Share-based compensation The Company accounts for employees’ and directors’ share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period using the straight-line method. Forfeitures are recognized as they occur. Share-based payments related to the employee share purchase plan (“ESPP”) are recognized based on the fair value of each award estimated on the first day of the offering period and recognized as an expense over the offering period using the straight-line method. The Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule using the straight-line method. |
Revenue recognition | Revenue recognition The Company accounts for its revenue transactions under Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 606, Revenue from Contracts with Customers. In accordance with ASC Topic 606, the Company recognizes revenues when its customers obtain control of its product for an amount that reflects the consideration it expects to receive from its customers in exchange for that product. To determine revenue recognition for contracts that are determined to be in scope of ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when such performance obligation is satisfied. As a result of the disposition of the MST Franchise in January 2022, the Company no longer has any revenue generating products; however, it still may receive royalty revenues from the sale of specified products (see Note 4, Discontinued Operations). Royalty Revenues and Collaboration Agreements The Company is entitled to royalty payments with respect to sales of a product developed by a customer in collaboration with the Company. This product was not part of the MST Franchise that was sold in January 2022. Royalties are recognized as revenue when the product is sold by the customer. Revenues in the amount of $0.4 million and $0.5 million were recorded during the year ended December 31, 2023 and 2022, respectively. For collaboration agreements under ASC 606, the Company identifies the contract, identifies the performance obligations, determines the transaction price, allocates the contract transaction price to the performance obligations, and recognizes the revenue when (or as) the performance obligation is satisfied. The Company identifies the performance obligations included within the agreement and evaluate which performance obligations are distinct. Upfront payments for licenses are evaluated to determine if the license is capable of being distinct from the obligations to participate on certain development and/or commercialization committees with the collaboration partners and supply manufactured drug product for clinical trials. For performance obligations that are satisfied over time, the Company utilizes the input method and revenue is recognized by consistently applying a method of measuring progress toward complete satisfaction of that performance obligation. The Company periodically reviews its estimated periods of performance based on the progress under each arrangement and accounts for the impact of any changes in estimated periods of performance on a prospective basis. Milestone payments are a form of variable consideration as the payments are contingent upon achievement of a substantive event. Milestone payments are estimated and included in the transaction price when the Company determines that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods. Product Revenues, net The Company’s net product revenues were generated through sales of AMZEEQ, which was approved by the FDA in October 2019 and was commercially launched in the United States in January 2020, and ZILXI, which was approved by the FDA in May 2020 and was commercially launched in the United States in October 2020. The Company sold the MST Franchise on January 12, 2022 and, as such, the Company no longer generates revenue from the sale of these products. The following is a description of the Company's accounting policies related to the sales of AMZEEQ and ZILXI. Product sales The Company’s customers were a limited number of national and select regional wholesalers (the “distributors”) and certain independent and specialty pharmacies (together, the “customers”). These distributors would subsequently resell the product, primarily to retail pharmacies that dispense the product to patients. Net product revenue was typically recognized when customers obtained control of the Company’s products, which occurred at a point in time, typically upon delivery of product to the customers. The Company evaluated the creditworthiness of its customers to determine whether it was probable that a significant reversal in the amount of the cumulative revenue recognized will not occur. The Company did not assess whether a contract had a significant financing component if the expectation was such that the period between the transfer of the promised goods to the customer and the receipt of payment would be less than one year. Standard credit terms did not exceed 75 days. The Company expensed incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that would have been recognized is one year or less or the amount is immaterial. Shipping and handling costs related to the Company’s product sales were included in selling, general and administrative expenses. Product revenue was recorded net of distribution fees, trade discounts, allowances, rebates, copay program coupons, chargebacks, estimated returns and other incentives. These reserves were classified as either reductions of accounts receivable or as current liabilities. The estimates of reserves established for variable consideration reflect contractual and statutory requirements, known market events and trends, industry data and forecasted customer mix. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, was subject to constraint and was included in the net product revenues only to the extent that it was probable that a significant reversal of the amount of the cumulative revenues recognized would not occur in a future period. Product Sales Provisions Provisions for distribution fees, trade discounts and chargebacks are reflected as a reduction to trade receivables, net on the consolidated balance sheet. All other provisions, including rebates, other discounts and return provisions are reflected as a liability within accrued expenses on the consolidated balance sheet. The revenue reserve accrual was $2.3 million and $2.7 million as of December 31, 2023 and December 31, 2022, respectively. Under the terms of the Asset Purchase Agreement, the Company retained and is responsible for historical liabilities of the commercial business operations based on events occurring prior to the sale other than those liabilities expressly assumed by Journey. Distribution Fees and Trade Discounts and Allowances The Company paid fees for distribution services and for certain data that distributors provided to the Company and generally provided discounts on sales to its distributors for prompt payment. These fees and discounts were contractual in nature and the Company expected its distributors to earn these fees and discounts, and accordingly deducted the full amount of these fees and discounts from its gross product revenues at the time such revenues were recognized. Rebates, Chargebacks and Other Discounts Product sales made under managed-care and governmental pricing programs in the United States were subject to rebates. Managed Care rebates related to contractual agreements to sell products to managed care organizations and pharmacy benefit managers at contractual rebate percentages in exchange for volume and/or market share. Chargebacks related to contractual agreements to sell products to government agencies and other indirect customers at contractual prices that are lower than the list prices the Company charges wholesalers. When these government agencies or other indirect customers purchased products through wholesalers at these reduced prices, the wholesaler charged the Company for the difference between the prices they paid the Company and the prices at which they sold the products to the indirect customers. The Company estimated the rebates and chargebacks it expected to be obligated to provide and deducted these estimated amounts from its gross product revenue at the time the revenue was recognized. The Company's estimates were based upon (i) the Company's contracts, (ii) estimates regarding the payor mix based on third-party data and utilization, (iii) inventory held by distributors and (iv) estimates of inventory held at the retail channel. Other discounts included the Company’s co-pay assistance coupon programs for commercially-insured patients meeting certain eligibility requirements. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expected to pay associated with product that had been recognized as revenue. Product Returns Consistent with industry practice, customers were generally allowed to return products within a specified period of time before and after its expiration date. The Company estimated the amount of product that would be returned and deducted these estimated amounts from its gross revenue at the time the revenue was recognized. T he information utilized to estimate the returns provision included: (i) actual return history (ii) historical return industry information regarding rates for comparable pharmaceutical products and product portfolios , (iii) external data with respect to inventory levels in the wholesale distribution channel, (iv) external data with respect to prescription demand for products and (v) remaining shelf lives of products at the date of sale. Contract Assets and Contract Liabilities The Company did not have any contract assets (unbilled receivables) related to product sales as of December 31, 2023 or 2022, as customer invoicing generally occured before or at the time of revenue recognition. The Company did not have any contract assets (unbilled receivables) related to its license revenues as of December 31, 2023 or 2022. The Company did not have any contract liabilities as of December 31, 2023 or 2022, as the Company did not receive payments in advance of fulfilling its performance obligations to its customers. |
Collaboration arrangements | Collaboration arrangements The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC Topic 808, Collaborative Arrangements |
Research and development costs | Research and development costs Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of clinical trials, clinical trial supplies, salaries, share-based compensation expenses, payroll taxes and other employee benefits, lab expenses, consumable equipment and consulting fees. All costs associated with research and developments are expensed as incurred. |
Fair value measurement | Fair value measurement Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data or active market data of similar or identical assets or liabilities. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. |
Income taxes | Income taxes: • Deferred taxes Income taxes are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable future. Given the Company’s losses, the Company has provided a full valuation allowance with respect to its deferred tax assets. • Uncertainty in income tax The Company follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the position will be sustained based on technical merits. If this threshold is met, the second step is to measure the tax position as the largest amount that has more than a 50% likelihood of being realized upon ultimate settlement. |
Net loss per share | Net loss per share |
Discontinued operations | Discontinued Operations The Company accounted for the sale of the MST Franchise in accordance with ASC 205, Discontinued Operations, and ASU No. 2014-08, Reporting of Discontinued Operations and Disclosures of Disposals of Components of an Entity . The Company followed the held-for-sale criteria as defined in ASC 360 Property, Plant and Equipment and ASC 205. ASC 205 requires that a component of an entity that has been disposed of or is classified as held for sale and has operations and cash flows that can be clearly distinguished from the rest of the entity be reported as assets held for sale and discontinued operations. In the period a component of an entity has been disposed of or classified as held for sale, the results of operations for the periods presented are reclassified into separate line items in the consolidated statements of operations. Assets and liabilities are also reclassified into separate line items on the related consolidated balance sheets for the periods presented. Non-cash items presented in the statement of cash flows and related to discontinued operations are presented in Note 4 - Discontinued Operations. ASU 2014-08 requires that only a disposal of a component of an entity, or a group of components of an entity, that represents a strategic shift that has, or will have, a major effect on the reporting entity’s operations and financial results be reported in the consolidated financial statements as discontinued operations. ASU 2014-08 also provides guidance on the financial statement presentations and disclosures of discontinued operations. Due to the sale of the MST Franchise during the first quarter of 2022, in accordance with ASC 205, the Company has classified the results of the MST Franchise as discontinued operations in its consolidated statements of operations and cash flows for all periods presented (see Note 4, Discontinued Operations). All disposed assets and liabilities associated with the MST Franchise were therefore classified as assets and liabilities of discontinued operations in the Company's consolidated balance sheets for the periods presented. All amounts included in the notes to the consolidated financial statements relate to continuing operations unless otherwise noted. |
Concentration of credit risks | Concentration of credit risks |
Warrants | Warrants The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC Topic 815, Derivatives and Hedging |
Newly issued and recently adopted accounting pronouncements | Newly issued and recently adopted accounting pronouncements : Recent Accounting Guidance Issued: In June 2016, the FASB issued Accounting Standards Update No. 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ” (ASU 2016-13), which requires companies to measure credit losses of financial instruments, including customer accounts receivable and marketable securities, utilizing a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Subsequent to the issuance of ASU 2016-13, the FASB issued several additional Accounting Standard Updates to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance. As a smaller reporting company, the Company adopted ASU 2016-13 effective January 1, 2023, and there was no material impact on the consolidated financial statements upon adoption. In March 2020, the FASB issued Accounting Standards Update No. 2020-04, " Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting " (ASU 2020-04), which provides guidance to alleviate the burden in accounting for reference rate reform by allowing certain expedients and exceptions in applying generally accepted accounting principles to contracts, hedging relationships, and other transactions impacted by reference rate reform. The provisions of ASU 2020-04 apply only to those transactions that reference LIBOR or another reference rate expected to be discontinued due to reference rate reform. Adoption of the provisions of ASU 2020-04 was optional through December 31, 2022. In December 2022, the FASB issued Accounting Standards Update No. 2022-06, " Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848" (ASU 2022-06), which provides extension of the sunset date of Topic 848 from December 31, 2022, to December 31, 2024. The Company is currently evaluating the impact of ASU 2020-04 and ASU 2022-06 on its consolidated financial statements. Currently, the Company does not expect the adoption of the new standard to have a material impact to the consolidated financial statements. In August 2020, the FASB issued ASU No. 2020-06, “ Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ” (“ASU 2020-06”), which simplifies the accounting for convertible instruments by eliminating the requirement to separately account for embedded conversion features as an equity component in certain circumstances. A convertible debt instrument will be reported as a single liability instrument with no separate accounting for an embedded conversion feature unless separate accounting is required for an embedded conversion feature as a derivative or under the substantial premium model. The ASU simplifies the diluted earnings per share calculation by requiring that an entity use the if-converted method and that the effect of potential share settlement be included in diluted earnings per share calculations. Further, the ASU requires enhanced disclosures about convertible instruments. The Company adopted ASU 2020-06 as of January 1, 2022 and there was no material impact on the consolidated financial statements upon adoption. In December 2023, the FASB issued ASU No. 2023-09, " Income Taxes (Topic 740)—Improvements to Income Tax Disclosures " ("ASU 2023-09"), which is intended to enhance the transparency and decision usefulness of income tax disclosures. Public business entities are required to adopt this standard for annual fiscal periods beginning after December 31, 2024 and early adoption is permitted. The Company is evaluating the impact the adoption of this guidance will have on its consolidated financial statements and related disclosures. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Useful Lives of Property, Plant, and Equipment | Annual rates of depreciation are as follows: Estimated Useful Life Computers 3 - 7 years Laboratory equipment 5 - 14 years Office furniture and equipment 7 - 14 years |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following stock options, restricted stock units (“RSUs”) and warrants were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented (data presented as numbers of shares): Year ended December 31, 2023 2022 Outstanding stock options and RSUs 1,205,516 313,403 Warrants 27,509 27,509 |
DISCONTINUED OPERATIONS (Tables
DISCONTINUED OPERATIONS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Schedule of Discontinued Operations of the MST Franchise | The following table presents the combined results of discontinued operations of the MST Franchise: Year ended December 31, (in thousands) 2023 2022 Product sales, net $ (525) $ (1,844) Cost of goods sold — 80 Operating expenses: Selling, general and administrative 55 259 Total operating expenses 55 259 Loss from discontinued operations (580) (2,183) Gain on the sale of the MST Franchise — 12,918 Income (loss) from discontinued operations, before income taxes (580) 10,735 Income tax expense — — Net income (loss) from discontinued operations $ (580) $ 10,735 The following table presents non-cash items related to discontinued operations, which are included in the Company's consolidated statement of cash flows for the year ended December 31, 2022: Year ended December 31, (in thousands) 2022 Cash Flows From Operating Activities: Stock-based compensation (income) expense* $ (352) Gain on the sale of the MST Franchise (12,918) Total non-cash items of discontinued operations $ (13,270) Supplemental disclosure of cash flow information: Amount due from sale of MST Franchise $ 5,000 *Income from stock-based compensation is related to forfeitures. The following table presents the gain on the sale of the MST Franchise: (in thousands) Year ended December 31, 2022 Cash proceeds 20,000 Proceeds received in January 2023 5,000 25,000 Less transaction costs (4,334) Less carrying value of assets sold (7,748) Gain on sale, before income taxes 12,918 Income tax expense — Gain on sale net of tax $ 12,918 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value Measurements, Recurring and Nonrecurring | The Company’s financial assets that are measured at fair value as of December 31, 2023 are classified in the tables below in one of the three categories described in "Note 2(q) - Fair value measurement" above: December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents $ 20,353 $ 10,267 $ — $ 30,620 Marketable securities — 62,633 — 62,633 Total assets $ 20,353 $ 72,900 $ — $ 93,253 |
MARKETABLE SECURITIES (Tables)
MARKETABLE SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Marketable Securities | The following tables sets forth the Company’s marketable securities: December 31, (in thousands) 2023 U.S. Government and agency bonds $ 31,886 U.S. Treasury bills 30,747 Total $ 62,633 |
Schedule of Debt Securities Available-for-sale | As of December 31, 2023, the fair value, amortized cost, gross unrealized gains, and gross unrealized losses were as follows: December 31, 2023 (in thousands) Amortized Gross Unrealized Gain Gross Unrealized Fair U.S Government and agency bonds 31,866 30 (10) 31,886 U.S Treasury bills 30,742 5 — 30,747 Total $ 62,608 $ 35 $ (10) $ 62,633 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Components of Accrued Expenses | Accrued expenses consisted of the following: December 31, 2023 2022 Product sales provisions $ 2,250 $ 2,695 Research and development 990 987 Professional services 648 519 Other 231 180 Total Accrued Expenses $ 4,119 $ 4,381 |
OPERATING LEASE (Tables)
OPERATING LEASE (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Schedule of Operating Lease Cost | The components of lease expense are as follows: (in thousands) Year Ended December 31, 2023 Year Ended December 31, 2022 Operating lease expense $ 32 $ 271 Short-term lease expense $ 86 $ 217 Variable lease expense $ (16) $ 69 Total lease expense $ 102 $ 557 Operating cash flows for amounts included in the measurement of lease liabilities are as follows: Year Ended December 31, 2023 Operating leases $ 25 Supplemental information related to leases are as follows: December 31, 2023 Operating lease right-of-use assets $ 207 Operating lease liabilities $ 214 Weighted average remaining lease term 1.75 Weighted average discount rate 8.00 % |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities are as follows: 2024 $ 126 2025 102 Total lease payments 228 Less imputed interest (14) Total lease liability $ 214 Current operating lease liabilities 115 Non-current operating lease liabilities 99 Total lease liability $ 214 |
MEZZANINE AND SHAREHOLDERS' E_2
MEZZANINE AND SHAREHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
Schedule Of Common Shares Reserved For Future Issuances | The Company had reserved shares of common stock for future issuance as follows: Year ended December 31, 2023 Shares underlying outstanding pre-funded warrants 28,482,594 Shares available for future grant under 2023 Plan (Note 13) 1,129,856 Common stock options outstanding (Note 13) 744,537 Outstanding restricted stock units (Note 13) 460,979 Shares available for grant under the Employee Stock Purchase Plan (Note 13) 101,202 Shares underlying other outstanding warrants 27,509 30,946,677 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share-based Compensation Awards Granted for Options and RSUs During the Period | In the years ended December 31, 2023 and 2022, the Company granted options and RSUs to employees and directors as follows: Year ended December 31, 2023 Award amount Exercise price range Vesting period Expiration Options 535,000 $2.70 1 year - 4 years 10 years RSUs 435,000 — 4 years — Year ended December 31, 2022 Award amount Exercise price range Vesting period Expiration Options 48,861 $5.62- $10.98 1 year - 4 years 10 years RSUs 40,339 — 4 years — |
Summary of Underlying Data Used for Computing the Fair Value of the Options | The underlying data used for computing the fair value of the options are as follows: Year ended December 31, 2023 2022 Fair value of stock option $2.18 - $2.23 $3.55 - $7.49 Dividend yield 0 % 0 % Expected volatility 104.42% - 105.64% 73.70% - 74.40% Risk-free interest rate 4.04% 2.20% - 2.92% Expected term 6 years 6 years |
Summary of Stock Option Activity | The following table summarizes stock option activity for the year ended December 31, 2023: Number of options Weighted Average Exercise Price Outstanding at December 31, 2022 229,787 $ 138.92 Granted 535,000 2.70 Forfeited (4,127) 72.81 Expired (16,123) 173.42 Outstanding at December 31, 2023 744,537 $ 40.65 Exercisable at December 31, 2023 176,688 $ 151.47 |
Summary of RSUs Activity | The following table summarizes RSU activity for the year ended December 31, 2023: Number of RSUs Weighted Average Grant Date Outstanding at December 31, 2022 83,616 $ 43.30 Awarded 435,000 2.70 Vested (53,845) 42.79 Forfeited (3,792) 49.88 Outstanding at December 31, 2023 460,979 $ 4.99 |
Schedule of Share-based Payment Arrangement, Expensed and Capitalized, Amount | The following table illustrates the allocation of share-based compensation within the line items on the statements of operations: Year ended December 31, 2023 2022 Research and development expenses 534 1,230 General and administrative expenses 2,771 3,419 Discontinued Operations* — (352) 3,305 4,297 *Income from stock-based compensation is related to forfeitures. |
INCOME TAX (Tables)
INCOME TAX (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Tax Taxes and Current Tax (Benefit) Expense | The loss before income taxes and the related tax (benefit) expense is as follows: Year ended December 31, (in thousands) 2023 2022 Income (loss) before income taxes: Domestic $ (28,459) $ (23,472) Foreign 7 279 Total loss before taxes $ (28,452) $ (23,193) Current taxes: Federal $ (123) $ — State 2 13 Foreign 121 — Total current taxes $ — $ 13 |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of income taxes at the U.S. federal statutory rate to the provision for income taxes is as follows: Year ended December 31, 2023 2022 Federal income tax provision at statutory rate 21.00 % 21.00 % State income tax provision, net of federal benefit (0.01) % (0.04) % Permanent differences (0.57) % (1.52) % Change in valuation allowances (20.42) % (19.49) % Other — % — % Effective income tax rate — % (0.05) % |
Schedule of Deferred Tax Assets and Liabilities | The significant components of the Company's deferred tax assets and liabilities are as follows: December 31, (in thousands) 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 72,508 $ 72,903 Tax credit carryforwards 6,851 7,794 Section 174 expenses 7,775 3,529 Share-based compensation 1,988 2,061 Accrued expenses and other 651 586 Total gross deferred tax assets 89,773 86,873 Less - valuation allowance (89,773) (86,873) Total deferred tax assets, net of valuation allowance $ — $ — Deferred tax liabilities: Other — — Right of use assets — — Total gross deferred tax liabilities — — Net deferred tax assets $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward | The following table summarizes the activity of the Company's unrecognized tax benefits (in thousands): Balance at January 1, 2022 $ 2,799 Additions for prior year positions — Additions for current year positions 55 Reductions related to expiration of statute of limitations — Balance at December 31, 2022 $ 2,854 Additions for prior year positions 19 Additions for current year positions 105 Reductions related to expiration of statute of limitations (520) Balance at December 31, 2023 $ 2,458 |
NATURE OF OPERATIONS (Details)
NATURE OF OPERATIONS (Details) | 12 Months Ended | |||||
Nov. 01, 2023 USD ($) | Oct. 27, 2023 $ / shares shares | Feb. 10, 2023 | Mar. 15, 2022 shares | Dec. 31, 2023 USD ($) segment $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | |
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Number of reportable segments | segment | 1 | |||||
Reverse stock split ratio | 0.0555 | |||||
Outstanding warrants to purchase common stock (in shares) | shares | 27,509 | 27,509 | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 8.40 | $ 76.78 | ||||
Cash, cash equivalents and restricted cash | $ 93,300,000 | |||||
Accumulated deficit | 691,336,000 | $ 662,735,000 | ||||
Net income (Loss) | (28,452,000) | (23,210,000) | ||||
Net cash used in operating activities | 25,341,000 | 29,200,000 | ||||
Loss from continuing operations | 27,872,000 | 33,945,000 | ||||
(Loss) income from discontinued operations, net of income taxes | (580,000) | $ 10,735,000 | ||||
Debt outstanding | 0 | |||||
Private Placement | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Number of shares issued in transaction (in shares) | shares | 10,652,543 | |||||
Price per share (in dollars per share) | $ / shares | $ 2.245 | |||||
Consideration received in a transaction | $ 88,200,000 | |||||
Payments of stock issuance costs | 5,486,000 | |||||
Net proceeds from private placement | 82,665,000 | |||||
Lincoln Park Equity Purchase Agreement | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Number of shares issued in transaction (in shares) | shares | 92,644 | |||||
Sale of stock, public float threshold | $ 75,000,000 | |||||
Pre-Funded Warrants | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Outstanding warrants to purchase common stock (in shares) | shares | 28,614,437 | |||||
Warrant exercise price (in dollars per share) | $ / shares | $ 0.0001 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Restricted cash | $ 100,000 | $ 100,000 | |
Provisions for doubtful accounts | 0 | 0 | |
Revenues | 424,000 | 477,000 | |
Revenue reserve accrual | 2,250,000 | 2,695,000 | |
Employee retention tax credit | 1,300,000 | ||
Proceeds from employee retention tax credit | $ 1,300,000 | ||
Other liabilities | $ 1,313,000 | $ 0 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES - Estimated Useful Life (Details) | Dec. 31, 2023 |
Computers | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Computers | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 7 years |
Laboratory equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
Laboratory equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 14 years |
Office furniture and equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 7 years |
Office furniture and equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 14 years |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES - Schedule of Antidilutive Equity Awards Not Included in the Calculation of EPS (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Outstanding stock options and RSUs | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 1,205,516 | 313,403 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 27,509 | 27,509 |
STRATEGIC AGREEMENTS (Details)
STRATEGIC AGREEMENTS (Details) | 1 Months Ended | 12 Months Ended | ||||||||||
Apr. 28, 2023 USD ($) | Feb. 27, 2023 USD ($) | Aug. 09, 2021 USD ($) | Apr. 30, 2021 USD ($) | Dec. 31, 2023 USD ($) | Jan. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Aug. 29, 2022 USD ($) | Aug. 29, 2022 GBP (£) | Jun. 28, 2022 USD ($) | Jun. 28, 2022 GBP (£) | Jan. 12, 2022 USD ($) | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||||||
Milestone payments receivable upon achievement of net sales | $ 450,000,000 | |||||||||||
Milestone payments upon achieving certain criteria, exceeding annual net sales | $ 100,000,000 | |||||||||||
Discontinued Operations, Disposed of by Sale | MST Franchise | ||||||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||||||
Cash proceeds | $ 20,000,000 | $ 20,000,000 | ||||||||||
Additional consideration receivable | $ 5,000,000 | |||||||||||
Option Agreement | ||||||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||||||
Payments for licensing agreements | $ 250,000 | $ 1,000,000 | ||||||||||
Payments for licensing agreements, percent used for development of compounds (percent) | 0.50 | |||||||||||
Oral BETi Option Agreement | ||||||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||||||
First payments for licensing agreements | $ 386,366 | £ 300,000 | ||||||||||
Second payment for licensing agreements | $ 997,407 | £ 850,000 | ||||||||||
VYN201 License Agreement | ||||||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||||||
Payments for licensing agreements | $ 500,000 | |||||||||||
Milestone payments upon achieving certain criteria, maximum | $ 15,750,000 | |||||||||||
Royalty payments, percentage one | 5% | |||||||||||
Royalty payments, percentage two | 7.50% | |||||||||||
Royalty payments, percentage three | 10% | |||||||||||
VYN 202 License Agreement | ||||||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||||||
Payments for licensing agreements | $ 3,750,000 | |||||||||||
Milestone payments upon achieving certain criteria, maximum | $ 43,750,000 | |||||||||||
Royalty payments, percentage one | 5% | |||||||||||
Royalty payments, percentage two | 7.50% | |||||||||||
Royalty payments, percentage three | 10% |
DISCONTINUED OPERATIONS - Disco
DISCONTINUED OPERATIONS - Discontinued Operations of the MST Franchise (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Discontinued Operation, Gain (Loss) on Disposal, Statement of Income or Comprehensive Income [Extensible Enumeration] | Net income (loss) from discontinued operations | |
Net income (loss) from discontinued operations | $ (580) | $ 10,735 |
Discontinued Operations, Disposed of by Sale | MST Franchise | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Cost of goods sold | 0 | 80 |
Selling, general and administrative | 55 | 259 |
Total operating expenses | 55 | 259 |
Loss from discontinued operations | (580) | (2,183) |
Gain on the sale of the MST Franchise | 0 | 12,918 |
Income (loss) from discontinued operations, before income taxes | (580) | 10,735 |
Income tax expense | 0 | 0 |
Net income (loss) from discontinued operations | (580) | 10,735 |
Product sales, net | Discontinued Operations, Disposed of by Sale | MST Franchise | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Product sales, net | $ (525) | $ (1,844) |
DISCONTINUED OPERATIONS - Non-C
DISCONTINUED OPERATIONS - Non-Cash Items Related to Discontinued Operations (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Discontinued Operation, Alternative Cash Flow Information [Abstract] | ||
Stock-based compensation (income) expense* | $ 3,305,000 | $ 4,297,000 |
Gain on the sale of the MST Franchise | 0 | (12,918,000) |
Supplemental disclosure of cash flow information: | ||
Amount due from sale of MST Franchise | 0 | 5,000,000 |
Discontinued Operations, Disposed of by Sale | MST Franchise | ||
Discontinued Operation, Alternative Cash Flow Information [Abstract] | ||
Stock-based compensation (income) expense* | (352,000) | |
Gain on the sale of the MST Franchise | (12,918,000) | |
Total non-cash items of discontinued operations | $ 0 | (13,270,000) |
Supplemental disclosure of cash flow information: | ||
Amount due from sale of MST Franchise | $ 5,000,000 |
DISCONTINUED OPERATIONS -Narrat
DISCONTINUED OPERATIONS -Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Discontinued Operations, Disposed of by Sale | MST Franchise | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Non-cash items of discontinued operations | $ 0 | $ 13,270,000 |
DISCONTINUED OPERATIONS - Gain
DISCONTINUED OPERATIONS - Gain on the Sale of the MST Franchise (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Jan. 12, 2022 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Proceeds received in January 2023 | $ 780,044 | $ 693,937 | |
Discontinued Operations, Disposed of by Sale | MST Franchise | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Cash proceeds | 20,000 | $ 20,000 | |
Total cash proceeds net | 25,000 | ||
Less transaction costs | (4,334) | ||
Less carrying value of assets sold | (7,748) | ||
Gain on sale, before income taxes | $ 0 | 12,918 | |
Income tax expense | 0 | ||
Gain on sale net of tax | $ 12,918 |
FAIR VALUE MEASUREMENT - Assets
FAIR VALUE MEASUREMENT - Assets Measured at Fair Value (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 30,620,000 | |
Marketable securities | 62,633,000 | |
Total assets | 93,253,000 | |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 20,353,000 | $ 28,000,000 |
Marketable securities | 0 | $ 0 |
Total assets | 20,353,000 | |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 10,267,000 | |
Marketable securities | 62,633,000 | |
Total assets | 72,900,000 | |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | |
Marketable securities | 0 | |
Total assets | $ 0 |
FAIR VALUE MEASUREMENT - Narrat
FAIR VALUE MEASUREMENT - Narrative (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 30,620,000 | |
Marketable securities | 62,633,000 | |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 20,353,000 | $ 28,000,000 |
Marketable securities | $ 0 | $ 0 |
MARKETABLE SECURITIES - Marketa
MARKETABLE SECURITIES - Marketable Securities (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Debt Securities, Available-for-sale [Line Items] | |
Marketable securities | $ 62,633 |
U.S. Government and agency bonds | |
Debt Securities, Available-for-sale [Line Items] | |
Marketable securities | 31,886 |
U.S. Treasury bills | |
Debt Securities, Available-for-sale [Line Items] | |
Marketable securities | $ 30,747 |
MARKETABLE SECURITIES - Fair Va
MARKETABLE SECURITIES - Fair Value, Cost and Gross Unrealized Holding Gains of Securities Owned (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | $ 62,608 |
Gross Unrealized Gain | 35 |
Gross Unrealized Loss | (10) |
Fair Value | 62,633 |
U.S. Government and agency bonds | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 31,866 |
Gross Unrealized Gain | 30 |
Gross Unrealized Loss | (10) |
Fair Value | 31,886 |
U.S. Treasury bills | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 30,742 |
Gross Unrealized Gain | 5 |
Gross Unrealized Loss | 0 |
Fair Value | $ 30,747 |
MARKETABLE SECURITIES - Narrati
MARKETABLE SECURITIES - Narrative (Details) $ in Millions | Dec. 31, 2023 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Marketable securities unrealized gain position | $ 62.6 |
PROPERTY AND EQUIPMENT - Narrat
PROPERTY AND EQUIPMENT - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Proceeds from sale of fixed assets | $ 0.3 | |
Depreciation | $ 0 | $ 0.1 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Product sales provisions | $ 2,250 | $ 2,695 |
Research and development | 990 | 987 |
Professional services | 648 | 519 |
Other | 231 | 180 |
Total Accrued Expenses | $ 4,119 | $ 4,381 |
OPERATING LEASE - Narrative (De
OPERATING LEASE - Narrative (Details) | 1 Months Ended | ||||
Mar. 13, 2019 USD ($) ft² | Nov. 30, 2022 ft² | Dec. 31, 2023 USD ($) | Oct. 01, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Operating Lease | |||||
Operating lease right-of-use assets | $ 207,000 | $ 200,000 | $ 0 | ||
Operating lease liabilities | $ 700,000 | $ 214,000 | $ 300,000 | $ 0 | |
Operating lease, weighted average discount rate, (in percent) | 8% | ||||
Weighted average remaining lease term | 1 year 9 months | ||||
ISRAEL | |||||
Operating Lease | |||||
Operating lease right-of-use assets | $ 0 | ||||
Operating lease liabilities | $ 0 | ||||
Operating lease terms | 1 year | ||||
Original Space | Bridgewater, New Jersey | |||||
Operating Lease | |||||
Facility space leased | ft² | 10,000 | 5,755 | |||
Operating lease right-of-use assets | $ 700,000 | ||||
Additional Space | Bridgewater, New Jersey | |||||
Operating Lease | |||||
Facility space leased | ft² | 4,639 | ||||
Operating lease right-of-use assets | $ 300,000 | ||||
Operating lease liabilities | $ 300,000 |
OPERATING LEASE - Schedule of O
OPERATING LEASE - Schedule of Operating Lease Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Leases [Abstract] | ||
Operating lease expense | $ 32 | $ 271 |
Short-term lease expense | 86 | 217 |
Variable lease expense | (16) | 69 |
Total lease expense | $ 102 | $ 557 |
OPERATING LEASE - Schedule of C
OPERATING LEASE - Schedule of Cash Paid for Lease Liabilities (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Office Building | |
Operating Lease | |
Operating leases | $ 25 |
OPERATING LEASE - Schedule of S
OPERATING LEASE - Schedule of Supplemental Information Related to Leases (Details) - USD ($) | Dec. 31, 2023 | Oct. 01, 2023 | Dec. 31, 2022 | Mar. 13, 2019 |
Leases [Abstract] | ||||
Operating lease right-of-use assets | $ 207,000 | $ 200,000 | $ 0 | |
Operating lease liabilities | $ 214,000 | $ 300,000 | $ 0 | $ 700,000 |
Weighted average remaining lease term | 1 year 9 months | |||
Weighted average discount rate | 8% |
OPERATING LEASE - Schedule of M
OPERATING LEASE - Schedule of Maturities of Lease Liabilities (Details) - USD ($) | Dec. 31, 2023 | Oct. 01, 2023 | Dec. 31, 2022 | Mar. 13, 2019 |
Leases [Abstract] | ||||
2024 | $ 126,000 | |||
2025 | 102,000 | |||
Total lease payments | 228,000 | |||
Less imputed interest | (14,000) | |||
Total lease liability | 214,000 | $ 300,000 | $ 0 | $ 700,000 |
Current operating lease liabilities | 115,000 | 0 | ||
Non-current operating lease liabilities | $ 99,000 | $ 0 |
EMPLOYEE SAVINGS PLAN (Details)
EMPLOYEE SAVINGS PLAN (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Company contributions to 401(k) plans | $ 0.1 | $ 0.1 |
MEZZANINE AND SHAREHOLDERS' E_3
MEZZANINE AND SHAREHOLDERS' EQUITY - Common Stock, Preferred Stock, and Warrants Narrative (Details) | 2 Months Ended | 12 Months Ended | |||||||||||
Mar. 01, 2024 USD ($) | Nov. 01, 2023 USD ($) | Oct. 27, 2023 $ / shares shares | Feb. 10, 2023 | Jan. 17, 2023 USD ($) shares | Nov. 14, 2022 USD ($) d $ / shares shares | Nov. 11, 2022 vote | Mar. 15, 2022 USD ($) shares | Aug. 12, 2021 USD ($) | Dec. 31, 2023 vote $ / shares shares | Dec. 31, 2023 USD ($) vote $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 shares | |
Class of Stock [Line Items] | |||||||||||||
Convertible preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 | 20,000,000 | ||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 3,000 | 0 | |||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||
Redemption price (percent) | 120% | ||||||||||||
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 | 150,000,000 | ||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||
Reverse stock split ratio | 0.0555 | ||||||||||||
Outstanding warrants to purchase common stock (in shares) | 27,509 | 27,509 | 27,509 | ||||||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 8.40 | $ 8.40 | $ 76.78 | ||||||||||
Shares reserved for future issuance (in shares) | 30,946,677 | 30,946,677 | |||||||||||
Cantor Sales Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of shares issued in transaction (in shares) | 34,589 | 143,770 | |||||||||||
Consideration received in a transaction | $ | $ 50,000,000 | ||||||||||||
Commission from gross proceeds from issuance of common stock | 3% | ||||||||||||
Price per share (in dollars per share) | $ / shares | $ 4.66 | $ 4.66 | $ 11.16 | ||||||||||
Proceeds from issuance from secondary offering | $ | $ 200,000 | $ 1,500,000 | |||||||||||
Cowen Sales Agreement | Subsequent Event | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Consideration received in a transaction | $ | $ 50,000,000 | ||||||||||||
Commission from gross proceeds from issuance of common stock | 3% | ||||||||||||
Lincoln Park Equity Purchase Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of shares issued in transaction (in shares) | 92,644 | ||||||||||||
Consideration receivable on transaction | $ | $ 30,000,000 | ||||||||||||
Term of equity purchase agreement | 36 months | ||||||||||||
Consideration receivable on additional transaction | $ | $ 900,000 | ||||||||||||
Private Placement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of shares issued in transaction (in shares) | 10,652,543 | ||||||||||||
Payments of stock issuance costs | $ | 5,486,000 | ||||||||||||
Consideration received in a transaction | $ | $ 88,200,000 | ||||||||||||
Price per share (in dollars per share) | $ / shares | $ 2.245 | ||||||||||||
Net proceeds from private placement | $ | $ 82,665,000 | ||||||||||||
Pre-Funded Warrants | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Outstanding warrants to purchase common stock (in shares) | 28,614,437 | ||||||||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||||
Period for notice of increase or decrease to beneficial ownership limitation | 60 days | ||||||||||||
Common stock, maximum beneficial ownership by holder (percent) | 19.99% | ||||||||||||
Shares reserved for future issuance (in shares) | 28,482,594 | 28,482,594 | |||||||||||
Warrants exercised (in shares) | 131,838 | ||||||||||||
Common stock | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of votes entitled to each ordinary share | vote | 1 | 1 | |||||||||||
Shares reserved for future issuance (in shares) | 744,537 | 744,537 | |||||||||||
Common stock | Private Placement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Net proceeds from private placement | $ | $ 1,000 | ||||||||||||
Additional paid-in capital | Private Placement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Net proceeds from private placement | $ | $ 82,664,000 | ||||||||||||
Series A Preferred Stock | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Convertible preferred stock, shares authorized (in shares) | 3,000 | 3,000 | |||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||||
Preferred stock, shares issued (in shares) | 0 | 0 | 3,000 | ||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 3,000 | ||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.1000 | ||||||||||||
Number of shares issued in transaction (in shares) | 3,000 | ||||||||||||
Preferred stock, value, subscriptions | $ | $ 300,000 | ||||||||||||
Proceeds from subscriptions of preferred stock | $ | $ 211,000 | ||||||||||||
Number of votes | vote | 1,000,000 | ||||||||||||
Preferred stock, conversion Price | $ / shares | $ 4.68 | ||||||||||||
Number of business days for conversion at option of holder after proposal approval or satisfaction of Nasdaq listing requirements | d | 15 | ||||||||||||
Redemption price (percent) | 120% | ||||||||||||
Stock right of redemption by holder following expiration of company redemption period, percent of stated value (percent) | 130% | ||||||||||||
Number of business days in automatic redemption period following delisting event | d | 5 | ||||||||||||
Redemption price of shares after delisting, percent of stated value (Percent) | 130% | ||||||||||||
Preferred stock, redemption amount | $ | $ 360,000 | ||||||||||||
Convertible Preferred Stock | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Payments of stock issuance costs | $ | $ 89,000 | $ 89,000 |
MEZZANINE AND SHAREHOLDERS' E_4
MEZZANINE AND SHAREHOLDERS' EQUITY - Common Stock for Future Issuance (Details) | Dec. 31, 2023 shares |
Class of Stock [Line Items] | |
Shares reserved for future issuance (in shares) | 30,946,677 |
Shareholder Lender | Foamix | |
Class of Stock [Line Items] | |
Shares reserved for future issuance (in shares) | 27,509 |
RSUs | |
Class of Stock [Line Items] | |
Shares reserved for future issuance (in shares) | 460,979 |
ESPP | |
Class of Stock [Line Items] | |
Shares reserved for future issuance (in shares) | 101,202 |
2023 Plan | |
Class of Stock [Line Items] | |
Shares reserved for future issuance (in shares) | 1,129,856 |
Common stock | |
Class of Stock [Line Items] | |
Shares reserved for future issuance (in shares) | 744,537 |
Pre-Funded Warrants | |
Class of Stock [Line Items] | |
Shares reserved for future issuance (in shares) | 28,482,594 |
SHARE-BASED COMPENSATION - Narr
SHARE-BASED COMPENSATION - Narrative (Details) | 12 Months Ended | |||
Dec. 31, 2023 USD ($) shares | Dec. 31, 2022 USD ($) shares | Feb. 28, 2024 shares | Apr. 06, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares reserved for future issuance (in shares) | 30,946,677 | |||
Shares issued during the period (in shares) | 15,261 | 7,549 | ||
Number of common stock issued per vesting RSU (in shares) | 1 | |||
Number of common stock issued per CSR (in shares) | 1.2082 | |||
Effective exchange ratio of Foamix ordinary shares into Menlo common stock | 1.8006 | |||
Weighted average remaining contractual term of outstanding options | 8 years 10 months 6 days | |||
Weighted average remaining contractual term of exercisable options | 5 years 8 months 26 days | |||
Unrecognized share based compensation expense, options | $ | $ 2,300,000 | |||
Aggregate intrinsic value of options outstanding | $ | 0 | |||
Aggregate intrinsic value of exercisable options | $ | $ 0 | |||
RSUs | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares reserved for future issuance (in shares) | 460,979 | |||
Fair value of options and RSUs granted | $ | $ 2,400,000 | $ 800,000 | ||
Share-based payment cost not yet recognized, weighted average period of recognition (in years) | 3 years 10 months 17 days | |||
Share-based payment cost, RSUs outstanding, weighted average period or recognition (in years) | 2 years 1 month 28 days | |||
Unrecognized share-based compensation cost | $ | $ 2,300,000 | |||
Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based payment cost not yet recognized, weighted average period of recognition (in years) | 3 years 1 month 17 days | |||
Employees and consultants | Foamix | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Incremental compensation costs incurred | $ | $ 46,000 | $ 200,000 | ||
Common stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares reserved for future issuance (in shares) | 744,537 | |||
2023 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares reserved for future issuance (in shares) | 1,129,856 | |||
2019 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares reserved for future issuance (in shares) | 0 | |||
2018 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares reserved for future issuance (in shares) | 0 | |||
ESPP | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares reserved for future issuance (in shares) | 101,202 | |||
Percentage of fair market value used as purchase price | 85% | |||
Percent of annual earnings that may be used to purchase shares | 15% | |||
2024 Inducement Plan | Subsequent Event | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares reserved for future issuance (in shares) | 500,000 |
SHARE-BASED COMPENSATION - Opti
SHARE-BASED COMPENSATION - Options and RSU Grants (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | 535,000 | |
Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | 535,000 | 48,861 |
Exercise price range (in dollars per share) | $ 2.70 | |
Exercise price range, minimum (in dollars per share) | $ 5.62 | |
Exercise price range, maximum (in dollars per share) | $ 10.98 | |
Expiration | 10 years | 10 years |
Options | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 1 year | 1 year |
Options | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years | 4 years |
RSUs | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
RSU, award amount (in shares) | 435,000 | 40,339 |
RSUs | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years | 4 years |
SHARE-BASED COMPENSATION - Sche
SHARE-BASED COMPENSATION - Schedule of Underlying Data Used for Computing the Fair Value of the Options (Details) - Options - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividend yield | 0% | 0% |
Expected volatility, minimum | 104.42% | 73.70% |
Expected volatility, maximum | 105.64% | 74.40% |
Risk-free interest rate | 4.04% | |
Risk-free interest rate, minimum | 2.20% | |
Risk-free interest rate, maximum | 2.92% | |
Expected term | 6 years | 6 years |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Fair value of stock option | $ 2.18 | $ 3.55 |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Fair value of stock option | $ 2.23 | $ 7.49 |
SHARE-BASED COMPENSATION - Summ
SHARE-BASED COMPENSATION - Summary of Stock Option Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of options | ||
Outstanding at end of period (in shares) | 229,787 | |
Granted (in shares) | 535,000 | |
Forfeited (in shares) | (4,127) | |
Expired (in shares) | (16,123) | |
Outstanding at end of period (in shares) | 229,787 | |
Outstanding and exercisable (in shares) | 176,688 | |
Weighted Average Exercise Price | ||
Outstanding at beginning of period (in dollars per share) | $ 138.92 | |
Granted (in dollars per share) | 2.70 | |
Forfeited (in dollars per share) | 72.81 | |
Expired (in dollars per share) | 173.42 | |
Outstanding at end of period (in dollars per share) | 40.65 | $ 138.92 |
Outstanding and exercisable (in dollars per share) | $ 151.47 |
SHARE-BASED COMPENSATION - Su_2
SHARE-BASED COMPENSATION - Summary of RSUs Activity (Details) - RSUs - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of RSUs | ||
Outstanding at beginning of period (in shares) | 83,616 | |
Awarded (in shares) | 435,000 | 40,339 |
Vested (in shares) | (53,845) | |
Forfeited (in shares) | (3,792) | |
Outstanding at end of period (in shares) | 83,616 | |
Weighted Average Grant Date Fair Value | ||
Outstanding at beginning of period (in dollars per share) | $ 43.30 | |
Outstanding at beginning of period (in dollars per share) | 4.99 | $ 43.30 |
Awarded (in dollars per share) | 2.70 | |
Vested (in dollars per share) | 42.79 | |
Forfeited (in dollars per share) | $ 49.88 |
SHARE-BASED COMPENSATION - Sc_2
SHARE-BASED COMPENSATION - Schedule of Share-based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share based compensation expense | $ 3,305 | $ 4,297 |
Research and development expenses | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share based compensation expense | 534 | 1,230 |
General and administrative expenses | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share based compensation expense | 2,771 | 3,419 |
Discontinued Operations* | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share based compensation expense | $ 0 | $ (352) |
INCOME TAX - Schedule of Income
INCOME TAX - Schedule of Income (Loss) Before Income Tax Taxes and Current Tax (Benefit) Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income (loss) before income taxes: | ||
Total loss before taxes | $ (28,452) | $ (23,193) |
Current taxes: | ||
Federal | (123) | 0 |
State | 2 | 13 |
Foreign | 121 | 0 |
Total current taxes | 0 | 13 |
Domestic | ||
Income (loss) before income taxes: | ||
Total loss before taxes | (28,459) | (23,472) |
Foreign | ||
Income (loss) before income taxes: | ||
Total loss before taxes | $ 7 | $ 279 |
INCOME TAX - Income Tax Reconci
INCOME TAX - Income Tax Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax provision at statutory rate | 21% | 21% |
State income tax provision, net of federal benefit | (0.01%) | (0.04%) |
Permanent differences | (0.57%) | (1.52%) |
Change in valuation allowances | (20.42%) | (19.49%) |
Other | 0% | 0% |
Effective income tax rate | 0% | (0.05%) |
INCOME TAX - Narrative (Details
INCOME TAX - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax [Line Items] | |||
Unrecognized Tax Benefits | $ 2,458 | $ 2,854 | $ 2,799 |
Deferred tax assets, valuation allowance | 89,773 | 86,873 | |
Increase (decrease) in valuation allowance, deferred tax assets | 2,900 | $ 1,300 | |
Domestic | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | 331,100 | ||
Tax credit carryforward | 6,900 | ||
Operating loss carryforwards, subject to expiration | 44,300 | ||
State and Local Jurisdiction | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | 41,700 | ||
Operating loss carryforwards, subject to expiration | $ 21,300 |
INCOME TAX - Schedule of Deferr
INCOME TAX - Schedule of Deferred Income Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 72,508 | $ 72,903 |
Tax credit carryforwards | 6,851 | 7,794 |
Section 174 expenses | 7,775 | 3,529 |
Share-based compensation | 1,988 | 2,061 |
Accrued expenses and other | 651 | 586 |
Total gross deferred tax assets | 89,773 | 86,873 |
Less - valuation allowance | (89,773) | (86,873) |
Total deferred tax assets, net of valuation allowance | 0 | 0 |
Deferred tax liabilities: | ||
Other | 0 | 0 |
Right of use assets | 0 | 0 |
Total gross deferred tax liabilities | 0 | 0 |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAX - Schedule of Activi
INCOME TAX - Schedule of Activity of the Company Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at the beginning of the period | $ 2,854 | $ 2,799 |
Additions for prior year positions | 19 | 0 |
Additions for current year positions | 105 | 55 |
Reductions related to expiration of statute of limitations | (520) | 0 |
Balance at the end of period | $ 2,458 | $ 2,854 |