Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | May 02, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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 $0.0001 | |
Trading Symbol | VYNE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 14,528,247 | |
Entity Central Index Key | 0001566044 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current Assets: | ||
Cash and cash equivalents | $ 19,065 | $ 30,620 |
Restricted cash | 54 | 54 |
Investment in marketable securities | 66,885 | 62,633 |
Prepaid and other current assets | 4,219 | 2,656 |
Total Current Assets | 90,223 | 95,963 |
Non-current Assets: | ||
Operating lease right-of-use assets | 180 | 207 |
Non-current prepaid expenses and other assets | 1,273 | 1,515 |
Assets, Noncurrent | 1,453 | 1,722 |
Total Assets | 91,676 | 97,685 |
Current Liabilities: | ||
Trade payables | 2,795 | 1,659 |
Accrued expenses | 3,642 | 4,119 |
Employee related obligations | 376 | 1,645 |
Operating lease liabilities | 117 | 115 |
Total Current Liabilities | 6,930 | 7,538 |
Long-term Liabilities: | ||
Non-current operating lease liabilities | 63 | 99 |
Other liabilities | 1,313 | 1,313 |
Total Long-term Liabilities | 1,376 | 1,412 |
Total Liabilities | 8,306 | 8,950 |
Commitments and Contingencies | ||
Stockholders' Equity: | ||
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at March 31, 2024 and December 31, 2023; no shares issued and outstanding at March 31, 2024 and December 31, 2023 | 0 | 0 |
Common stock: $0.0001 par value; 150,000,000 shares authorized at March 31, 2024 and December 31, 2023; 14,301,688 and 14,098,888 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 1 | 1 |
Additional paid-in capital | 781,024 | 780,044 |
Accumulated other comprehensive (loss) income | (70) | 26 |
Accumulated deficit | (697,585) | (691,336) |
Total Stockholders' Equity | 83,370 | 88,735 |
Total Liabilities and Stockholders’ Equity | $ 91,676 | $ 97,685 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
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) | 14,301,688 | 14,098,888 |
Common stock shares outstanding (in shares) | 14,301,688 | 14,098,888 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Statement [Abstract] | ||
Revenues | $ 98 | $ 99 |
Operating expenses: | ||
Research and development | 3,708 | 2,734 |
General and Administrative Expense | 3,770 | 3,240 |
Total operating expenses | 7,478 | 5,974 |
Operating loss | (7,380) | (5,875) |
Other income, net | 1,139 | 263 |
Loss from continuing operations before income taxes | (6,241) | (5,612) |
Income tax expense | 0 | 0 |
Loss from continuing operations | (6,241) | (5,612) |
Loss from discontinued operations, net of income taxes | (8) | (10) |
Net loss | $ (6,249) | $ (5,622) |
Loss per share from continuing operations, basic (in dollars per share) | $ (0.15) | $ (1.74) |
Loss per share from continuing operations, diluted (in dollars per share) | (0.15) | (1.74) |
Loss per share from discontinued operations, basic (in dollars per share) | 0 | 0 |
Loss per share from discontinued operations, diluted (in dollars per share) | 0 | 0 |
Loss per share, basic (in dollars per share) | (0.15) | (1.74) |
Loss per share, diluted (in dollars per share) | $ (0.15) | $ (1.74) |
Weighted average shares outstanding - basic (in shares) | 42,581 | 3,255 |
Weighted average shares outstanding - diluted (in shares) | 42,581 | 3,255 |
Other Comprehensive Income (Loss), Net of Tax [Abstract] | ||
Unrealized loss on marketable securities, net of tax of $0 | $ (96) | $ 0 |
Total other comprehensive loss | (96) | 0 |
Comprehensive loss | $ (6,345) | $ (5,622) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Income Statement [Abstract] | |
Unrealized loss on marketable securities, tax | $ 0 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common stock | Common stock At-the-market Offering | Additional paid-in capital | Additional paid-in capital At-the-market Offering | Accumulated other comprehensive Income (loss) | Accumulated deficit |
Beginning balance (in shares) at Dec. 31, 2022 | 3,000 | ||||||
Beginning balance at Dec. 31, 2022 | $ 211 | ||||||
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 Mar. 31, 2023 | 0 | ||||||
Ending balance at Mar. 31, 2023 | $ 0 | ||||||
Beginning balance (shares) at Dec. 31, 2022 | 3,229,704 | ||||||
Beginning balance at Dec. 31, 2022 | 31,202 | $ 0 | $ 693,937 | $ 0 | $ (662,735) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net loss | (5,622) | (5,622) | |||||
Redemption of convertible preferred stock | (149) | (149) | |||||
Vesting of restricted stock units, net of withholding tax and shares issued under employee stock purchase plan (in shares) | 6,989 | ||||||
Vesting of restricted stock units, net of withholding tax and shares issued under employee stock purchase plan | (12) | (12) | |||||
Stock-based compensation | 856 | 856 | |||||
Issuance of common stock under at-the-market offering, net of issuance costs (in shares) | 34,589 | ||||||
Issuance of common stock under at-the-market offering, net of issuance costs | 156 | $ 156 | |||||
Unrealized losses from marketable securities | 0 | ||||||
Ending balance (shares) at Mar. 31, 2023 | 3,271,282 | ||||||
Ending balance at Mar. 31, 2023 | $ 26,431 | $ 0 | 694,937 | 0 | (668,506) | ||
Beginning balance (in shares) at Dec. 31, 2023 | 0 | ||||||
Beginning balance at Dec. 31, 2023 | $ 0 | ||||||
Ending balance (in shares) at Mar. 31, 2024 | 0 | ||||||
Ending balance at Mar. 31, 2024 | $ 0 | ||||||
Beginning balance (shares) at Dec. 31, 2023 | 14,098,888 | 14,098,888 | |||||
Beginning balance at Dec. 31, 2023 | $ 88,735 | $ 1 | 780,044 | 26 | (691,336) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net loss | (6,249) | (6,249) | |||||
Vesting of restricted stock units, net of withholding tax and shares issued under employee stock purchase plan (in shares) | 2,809 | ||||||
Vesting of restricted stock units, net of withholding tax and shares issued under employee stock purchase plan | (5) | (5) | |||||
Stock-based compensation | 985 | 985 | |||||
Cashless exercise of pre-funded warrants (in shares) | 199,991 | ||||||
Unrealized losses from marketable securities | $ (96) | (96) | |||||
Ending balance (shares) at Mar. 31, 2024 | 14,301,688 | 14,301,688 | |||||
Ending balance at Mar. 31, 2024 | $ 83,370 | $ 1 | $ 781,024 | $ (70) | $ (697,585) |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
At-the-market Offering | |
Payments of stock issuance costs | $ 5 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (6,249) | $ (5,622) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 985 | 856 |
Amortization of premium or discount on marketable securities | (777) | 0 |
Unrealized losses on cash equivalents | (1) | 0 |
Changes in operating assets and liabilities: | ||
Trade receivables, prepaid expenses and other assets and operating lease right-of-use assets | (1,294) | (200) |
Trade payables, accrued expenses, employee related obligations and other long-term liabilities | (612) | (512) |
Operating lease liabilities | (34) | 0 |
Net cash used in operating activities | (7,982) | (5,478) |
Cash Flows From Investing Activities: | ||
Proceeds from the sale of the MST Franchise | 0 | 5,000 |
Proceeds from sale and maturity of marketable securities | 11,600 | 0 |
Purchases of marketable securities | (15,169) | 0 |
Net cash (used in) provided by investing activities | (3,569) | 5,000 |
Cash Flows From Financing Activities: | ||
Proceeds related to issuance of common stock through at-the-market offerings, net of issuance costs | 0 | 156 |
Redemption of convertible preferred stock | 0 | (360) |
Withholdings from exercise of options and issuance of shares for stock-based compensation arrangements, net | (4) | (13) |
Net cash used in financing activities | (4) | (217) |
Decrease in cash, cash equivalents and restricted cash | (11,555) | (695) |
Cash, cash equivalents and restricted cash at beginning of the period | 30,674 | 30,975 |
Cash, cash equivalents and restricted cash at end of the period | 19,119 | 30,280 |
Cash and cash equivalents | 19,065 | 30,213 |
Restricted cash | 54 | 67 |
Total cash, cash equivalents and restricted cash | 19,119 | 30,280 |
Supplementary information on investing and financing activities not involving cash flows: | ||
Accretion of preferred stock | $ 0 | $ 149 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NATURE OF OPERATIONS 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 Limited, 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. In addition, in October 2023, the Company announced positive results from a Phase 1b trial evaluating VYN201 in nonsegmental vitiligo. 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 ("Journey") 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 holder of fractional shares was entitled to receive a cash payment (without interest or deduction) from the Company’s transfer agent in an amount equal to such holder’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 stock and per share amounts contained in the unaudited condensed 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”), pursuant 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 thereof (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, before deducting fees to the placement agent and offering expenses payable by the Company. This transaction resulted in $5.5 million of issuance costs and net proceeds of $82.7 million. Liquidity and Capital Resources As of March 31, 2024, the Company had cash, cash equivalents, restricted cash and marketable securities of $86.0 million and an accumulated deficit of $697.6 million. The Company had no outstanding debt as of March 31, 2024. For the three months ended March 31, 2024, the Company incurred a net loss of $6.2 million and used $8.0 million of cash in operations. 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. In addition, 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 Quarterly Report on Form 10-Q, 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. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | SIGNIFICANT ACCOUNTING POLICIES a. Basis of Presentation The unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s unaudited condensed consolidated financial position, results of operations, cash flow and statement of stockholders' equity for the interim periods presented. Certain information and disclosures normally included in the annual audited consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 1, 2024. The results for the three months ended March 31, 2024 are not necessarily indicative of the results expected for the year ending December 31, 2024. b. Principles of Consolidation The unaudited interim condensed 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 unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and 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. Cash and cash equivalents The Company considers cash equivalents to be 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. e. Restricted cash As of each of March 31, 2024 and December 31, 2023, the Company had restricted cash of $0.1 million representing bank guarantees. f. 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 stockholders’ 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. g. Revenue Recognition The Company accounts for its revenue transactions under the 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 of $0.1 million were recorded for both the three months ended March 31, 2024 and 2023. 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 evaluates 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 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 are 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 Provisions Provisions for distribution fees, trade discounts and chargebacks are reflected as a reduction to trade receivables, net on the unaudited condensed consolidated balance sheet. All other provisions, including rebates, other discounts and return provisions are reflected as a liability within accrued expenses on the unaudited condensed consolidated balance sheet. The revenue reserve accrual was $2.4 million and $2.3 million as of March 31, 2024 and December 31, 2023, 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. Product Returns Consistent with industry practice, customers were generally allowed to return products within a specified period of time before and after the 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 includes: (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 March 31, 2024 or December 31, 2023, as customer invoicing generally occurred 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 March 31, 2024 or December 31, 2023. The Company did not have any contract liabilities as of March 31, 2024 or December 31, 2023, as the Company did not receive payments in advance of fulfilling its performance obligations to its customers. h. 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. i. 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, stock-based compensation expenses, payroll taxes and other employee benefits, lab expenses, consumable equipment and consulting fees. All costs associated with research and development are expensed as incurred. j. Credit losses An allowance is maintained for potential credit losses in accordance with accounting standards update ("ASU") No. 2016-13, Financial Instruments - Credit Losses . 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 three months ended March 31, 2024 and 2023. k. 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. l. 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 shares 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 number of shares): March 31, 2024 2023 Outstanding stock options and RSUs 2,210,974 290,121 Warrants 27,509 27,509 m. 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 unaudited condensed consolidated statements of operations. Assets and liabilities are also reclassified into separate line items on the related unaudited condensed 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 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 unaudited condensed 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 unaudited condensed consolidated balance sheets for the periods presented. All amounts included in the notes to the unaudited condensed consolidated financial statements relate to continuing operations unless otherwise noted. n. 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 receivable. 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 their immaterial nature. Restricted cash as of March 31, 2024 was $0.1 million, which does not present a credit risk due to its immaterial nature. o. 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 unaudited condensed consolidated balance sheet as of March 31, 2024 until such a time that the Company has reasonable assurance that the conditions associated with the grants have been met. p. 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 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 March 31, 2024 and December 31, 2023, all of the Company's outstanding warrants were equity-classified warrants. q. Newly issued and recently adopted accounting pronouncements Recent Accounting Guidance Issued: In June 2016, the FASB issued Accounting Standard 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 as of January 1, 2023, and there was no material impact on the unaudited condensed consolidated financial statements upon adoption. 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 unaudited condensed consolidated financial statements. Currently, the Company does not expect the adoption of the new standard to have a material impact on the unaudited condensed consolidated financial statements. 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 unaudited condensed consolidated financial statements and related disclosures. |
STRATEGIC AGREEMENTS
STRATEGIC AGREEMENTS | 3 Months Ended |
Mar. 31, 2024 | |
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 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 pursuant to which the Company sold its MST Franchise to Journey. The assets include 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 | 3 Months Ended |
Mar. 31, 2024 | |
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 . 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, and general and administrative expenses in discontinued operations include corporate costs incurred directly to solely support the MST Franchise. For the three months ended March 31, 2024 and 2023 the loss from discontinued operations, net of income taxes was $8.0 thousand and $10.0 thousand, respectively, and consisted solely of general and administrative expenses. There were no non-cash items related to discontinued operations for the three months ended March 31, 2024 and 2023. The 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 | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS The Company’s financial assets that are measured at fair value as of March 31, 2024 and December 31, 2023 are classified in the tables below in one of the three categories described in “Fair value measurement” in "Note 2 - Significant Accounting Policies” above: March 31, 2024 (in thousands) Level 1 Level 2 Level 3 Total Cash and cash equivalents $ 19,065 $ — $ — $ 19,065 Marketable securities — 66,885 — 66,885 Total assets $ 19,065 $ 66,885 $ — $ 85,950 December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Cash and cash equivalents $ 20,353 $ 10,267 $ — $ 30,620 Marketable securities — 62,633 — 62,633 Total assets $ 20,353 $ 72,900 $ — $ 93,253 Other financial instruments consist of trade receivables, trade payables and accrued expenses. The fair value of these financial instruments approximates their carrying value due to their short-term nature. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 3 Months Ended |
Mar. 31, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | MARKETABLE SECURITIES As of March 31, 2024 and December 31, 2023, marketable securities consisted of U.S. Government and agency bonds as well as U.S. Treasury bills. The following table sets forth the Company’s marketable securities: March 31, December 31, (in thousands) 2024 2023 U.S. Government and agency debt securities $ 42,449 $ 31,886 U.S. Treasury bills 24,436 30,747 Total $ 66,885 $ 62,633 As of March 31, 2024 and December 31, 2023, the amortized cost, gross unrealized gains, gross unrealized losses and fair value were as follows: March 31, 2024 (in thousands) Amortized Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. Government and agency debt securities $ 42,514 $ — $ (65) $ 42,449 U.S. Treasury bills 24,441 — (5) 24,436 Total $ 66,955 $ — $ (70) $ 66,885 December 31, 2023 (in thousands) Amortized Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. Government and agency debt securities $ 31,866 $ 30 $ (10) $ 31,886 U.S. Treasury bills 30,742 5 — 30,747 Total $ 62,608 $ 35 $ (10) $ 62,633 As of March 31, 2024, $66.9 million of the marketable securities were in an unrealized loss position. 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 periods ended March 31, 2024 and December 31, 2023. All maturities are less than 12 months. |
MEZZANINE EQUITY AND STOCKHOLDE
MEZZANINE EQUITY AND STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
MEZZANINE EQUITY AND STOCKHOLDERS' EQUITY | MEZZANINE EQUITY AND STOCKHOLDERS' EQUITY Preferred stock As of March 31, 2024, 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 were no shares of preferred stock issued and outstanding as of March 31, 2024 and December 31, 2023. 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 ("AlphaCentric"), 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 its stockholders for the purpose of presenting 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 AlphaCentric, 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 Convertible 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 provided, 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 satisfies 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 AlphaCentric. 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 Stock. The Certificate (i) eliminated the previous designation of 3,000 shares of Series A Preferred Stock 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 Stock 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 vote. 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 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 holder of fractional shares was entitled to receive a cash payment (without interest or deduction) in an amount equal to such holder’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 stock and per share amounts contained in the unaudited condensed consolidated financial statements have been retroactively adjusted to reflect the 1-for-18 reverse stock split. Issuances of common stock At-the-Market Equity Offering Program 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 three months ended March 31, 2023, the Company issued and sold 34,589 shares of common stock at a weighted average per share price of $4.52 pursuant to the Cantor Sales Agreement for $0.2 million in net proceeds. The Company did not sell any shares of Common Stock under the Cantor Sales Agreement during the three months ended March 31, 2024. 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. The Company did not sell any shares of common stock under the Cowen Sales Agreement during the three months ended March 31, 2024. Private Placement On October 27, 2023, the Company entered into a Securities Purchase Agreement, pursuant to which the Company agreed to sell and issue to the Purchasers in a 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 thereof. The Stock Purchase Price 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, before deducting fees to the placement agent and offering expenses payable by the Company. This transaction resulted in $5.5 million of issuance costs and net proceeds of $82.7 million. 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, 131,843 of Pre-Funded Warrants were cashless exercised. During the three months ended March 31, 2024, 200,000 of Pre-Funded Warrants were cashless exercised. At March 31, 2024, 28,282,594 Pre-Funded Warrants remained outstanding. Other Warrants As of March 31, 2024 and December 31, 2023, the Company had warrants to purchase an aggregate of 27,509 shares of the Company’s common stock outstanding, with an exercise price of $8.40, 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 issues common stock at a price per share less than the exercise price (the "Down Round Feature"). In the event that the Down Round Feature is triggered, the Company must calculate 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 exercise price will be adjusted in the event the Company issues additional shares of common stock below the then-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. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION 2023 Equity Incentive Plan: The Company maintains the 2023 Equity Incentive Plan (the "2023 Plan") and previously maintained the 2019 Equity Incentive Plan (the “2019 Plan”) and 2018 Omnibus Incentive Plan (the "2018 Plan"). Following stockholder approval in December 2023, any shares then available for future grant under the 2019 Plan and 2018 Plan were allocated to the 2023 Plan. As of March 31, 2024, 120,168 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 March 31, 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 March 31, 2024, 101,202 shares remained available for grant under the ESPP. For both the three months ended March 31, 2024 and 2023, no shares were issued to employees pursuant to the ESPP. Options and Restricted Stock Units ("RSUs") granted to employees and directors: For the three months ended March 31, 2024, the Company granted options and RSUs to employees and directors as follows. Three Months Ended March 31, 2024 Award amount Exercise price range Vesting period Expiration Options 575,000 $ 2.33 1 year - 4 years 10 years RSUs 435,000 $ — 4 years — During the three months ended March 31, 2024, the fair value of options and RSUs granted to employees and directors was $2.1 million. There were no options or RSUs granted to employees and directors for the three months ended March 31, 2023. The fair value of RSUs granted is based on the share price on the grant date. One share of common stock will be issued upon settlement of each RSU that vests. 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: Three Months Ended March 31, 2024 Fair value of common stock $1.88 - $1.94 Dividend yield 0 % Expected volatility 104.63% - 105.71% Risk-free interest rate 3.95 % Expected term 6 years Stock-based compensation expenses: The following table illustrates the effect of stock-based compensation on the line items on the unaudited condensed consolidated statements of operations: Three Months Ended March 31, (in thousands) 2024 2023 Research and development expenses $ 163 $ 44 General and administrative 822 812 Total $ 985 $ 856 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Litigation and contingencies The Company may periodically become subject to legal proceedings and claims arising in connection with its business. As of March 31, 2024, there were no claims or actions pending against the Company that, in the opinion of management, are likely to have a material adverse effect on the Company. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (6,249) | $ (5,622) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s unaudited condensed consolidated financial position, results of operations, cash flow and statement of stockholders' equity for the interim periods presented. Certain information and disclosures normally included in the annual audited consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 1, 2024. The results for the three months ended March 31, 2024 are not necessarily indicative of the results expected for the year ending December 31, 2024. |
Principles of Consolidation | Principles of Consolidation The unaudited interim condensed 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 unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and 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. |
Cash and cash equivalents | Cash and cash equivalents |
Restricted cash | Restricted cash As of each of March 31, 2024 and December 31, 2023, 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 stockholders’ 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. |
Revenue Recognition | Revenue Recognition The Company accounts for its revenue transactions under the 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 of $0.1 million were recorded for both the three months ended March 31, 2024 and 2023. 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 evaluates 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 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 are 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 Provisions Provisions for distribution fees, trade discounts and chargebacks are reflected as a reduction to trade receivables, net on the unaudited condensed consolidated balance sheet. All other provisions, including rebates, other discounts and return provisions are reflected as a liability within accrued expenses on the unaudited condensed consolidated balance sheet. The revenue reserve accrual was $2.4 million and $2.3 million as of March 31, 2024 and December 31, 2023, 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. Product Returns Consistent with industry practice, customers were generally allowed to return products within a specified period of time before and after the 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 includes: (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 March 31, 2024 or December 31, 2023, as customer invoicing generally occurred 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 March 31, 2024 or December 31, 2023. The Company did not have any contract liabilities as of March 31, 2024 or December 31, 2023, as the Company did not receive payments in advance of fulfilling its performance obligations to its customers. |
Collaboration agreements | 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, stock-based compensation expenses, payroll taxes and other employee benefits, lab expenses, consumable equipment and consulting fees. All costs associated with research and development are expensed as incurred. |
Credit losses | Credit losses An allowance is maintained for potential credit losses in accordance with accounting standards update ("ASU") No. 2016-13, Financial Instruments - Credit Losses . 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 |
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. |
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 unaudited condensed consolidated statements of operations. Assets and liabilities are also reclassified into separate line items on the related unaudited condensed 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 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 unaudited condensed 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 unaudited condensed consolidated balance sheets for the periods presented. All amounts included in the notes to the unaudited condensed 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 (“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 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 |
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 Standard 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 as of January 1, 2023, and there was no material impact on the unaudited condensed consolidated financial statements upon adoption. 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 unaudited condensed consolidated financial statements. Currently, the Company does not expect the adoption of the new standard to have a material impact on the unaudited condensed consolidated financial statements. 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 unaudited condensed consolidated financial statements and related disclosures. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
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 number of shares): March 31, 2024 2023 Outstanding stock options and RSUs 2,210,974 290,121 Warrants 27,509 27,509 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 and December 31, 2023 are classified in the tables below in one of the three categories described in “Fair value measurement” in "Note 2 - Significant Accounting Policies” above: March 31, 2024 (in thousands) Level 1 Level 2 Level 3 Total Cash and cash equivalents $ 19,065 $ — $ — $ 19,065 Marketable securities — 66,885 — 66,885 Total assets $ 19,065 $ 66,885 $ — $ 85,950 December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Cash and cash equivalents $ 20,353 $ 10,267 $ — $ 30,620 Marketable securities — 62,633 — 62,633 Total assets $ 20,353 $ 72,900 $ — $ 93,253 |
MARKETABLE SECURITIES (Tables)
MARKETABLE SECURITIES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Marketable Securities | The following table sets forth the Company’s marketable securities: March 31, December 31, (in thousands) 2024 2023 U.S. Government and agency debt securities $ 42,449 $ 31,886 U.S. Treasury bills 24,436 30,747 Total $ 66,885 $ 62,633 |
Schedule of Debt Securities Available-for-sale | As of March 31, 2024 and December 31, 2023, the amortized cost, gross unrealized gains, gross unrealized losses and fair value were as follows: March 31, 2024 (in thousands) Amortized Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. Government and agency debt securities $ 42,514 $ — $ (65) $ 42,449 U.S. Treasury bills 24,441 — (5) 24,436 Total $ 66,955 $ — $ (70) $ 66,885 December 31, 2023 (in thousands) Amortized Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. Government and agency debt securities $ 31,866 $ 30 $ (10) $ 31,886 U.S. Treasury bills 30,742 5 — 30,747 Total $ 62,608 $ 35 $ (10) $ 62,633 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share-based Compensation Awards Granted for Options and RSUs During the Period | For the three months ended March 31, 2024, the Company granted options and RSUs to employees and directors as follows. Three Months Ended March 31, 2024 Award amount Exercise price range Vesting period Expiration Options 575,000 $ 2.33 1 year - 4 years 10 years RSUs 435,000 $ — 4 years — |
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: Three Months Ended March 31, 2024 Fair value of common stock $1.88 - $1.94 Dividend yield 0 % Expected volatility 104.63% - 105.71% Risk-free interest rate 3.95 % Expected term 6 years |
Schedule of Share-based Payment Arrangement, Expensed and Capitalized, Amount | The following table illustrates the effect of stock-based compensation on the line items on the unaudited condensed consolidated statements of operations: Three Months Ended March 31, (in thousands) 2024 2023 Research and development expenses $ 163 $ 44 General and administrative 822 812 Total $ 985 $ 856 |
NATURE OF OPERATIONS (Details)
NATURE OF OPERATIONS (Details) | 3 Months Ended | |||||
Nov. 01, 2023 USD ($) | Oct. 27, 2023 $ / shares shares | Feb. 10, 2023 | Mar. 31, 2024 USD ($) segment shares | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Number of reportable segments | segment | 1 | |||||
Reverse stock split ratio | 0.0556 | |||||
Outstanding warrants to purchase common stock (in shares) | shares | 27,509 | |||||
Cash and investments | $ 86,000,000 | |||||
Accumulated Deficit | 697,585,000 | $ 691,336,000 | ||||
Debt outstanding | 0 | |||||
Net loss | 6,249,000 | $ 5,622,000 | ||||
Cash used in operations | 7,982,000 | $ 5,478,000 | ||||
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 | 5,500,000 | |||||
Net proceeds from private placement | $ 82,700,000 | |||||
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 | |||||
Lincoln Park Equity Purchase Agreement | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Sale of stock, public float threshold | $ 75,000,000 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | |
Accounting Policies [Abstract] | |||||
Restricted cash | $ 100,000 | $ 100,000 | |||
Revenues | 98,000 | $ 99,000 | |||
Revenue reserve accrual | 2,400,000 | 2,300,000 | |||
Provisions for doubtful accounts | 0 | $ 0 | |||
Employee retention tax credit | $ 1,300,000 | ||||
Proceeds from employee retention tax credit | $ 1,300,000 | ||||
Other liabilities | $ 1,313,000 | $ 1,313,000 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES - Schedule of AntiDilutive Equity Awards Not Included in the Calculation of EPS (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Outstanding stock options and RSUs | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 2,210,974 | 290,121 |
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) £ in Thousands | 1 Months Ended | 3 Months Ended | |||||||||
Apr. 28, 2023 USD ($) | Feb. 27, 2023 USD ($) | Aug. 09, 2021 USD ($) | Apr. 30, 2021 USD ($) | Mar. 31, 2024 USD ($) | Jan. 31, 2023 USD ($) | 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 | ||||||||||
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 | 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 | |||||||||
Second payment for licensing agreements | $ 997,407 | £ 850 | |||||||||
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 - Narra
DISCONTINUED OPERATIONS - Narrative (Details) - Discontinued Operations, Disposed of by Sale - MST Franchise - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Loss from discontinued operations, net of income taxes, consisting solely of general and administrative expenses. | $ 8,000 | $ 10,000 |
Non-cash items of discontinued operations | $ 0 | $ 0 |
FAIR VALUE MEASUREMENTS - Asset
FAIR VALUE MEASUREMENTS - Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 19,065 | $ 30,620 |
Marketable securities | 66,885 | 62,633 |
Total assets | 85,950 | 93,253 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 19,065 | 20,353 |
Marketable securities | 0 | 0 |
Total assets | 19,065 | 20,353 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | 10,267 |
Marketable securities | 66,885 | 62,633 |
Total assets | 66,885 | 72,900 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Marketable securities | 0 | 0 |
Total assets | $ 0 | $ 0 |
MARKETABLE SECURITIES - Marketa
MARKETABLE SECURITIES - Marketable Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities | $ 66,885 | $ 62,633 |
U.S. Government and agency debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities | 42,449 | 31,886 |
U.S. Treasury bills | ||
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities | $ 24,436 | $ 30,747 |
MARKETABLE SECURITIES - Narrati
MARKETABLE SECURITIES - Narrative (Details) - USD ($) $ in Millions | Mar. 31, 2024 | Dec. 31, 2023 |
Investments, Debt and Equity Securities [Abstract] | ||
Marketable securities unrealized gain position | $ 66.9 | $ 62.6 |
MARKETABLE SECURITIES - Fair Va
MARKETABLE SECURITIES - Fair Value, Cost and Gross Unrealized Holding Gains of Securities Owned (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 66,955 | $ 62,608 |
Gross Unrealized Gains | 0 | 35 |
Gross Unrealized Losses | (70) | (10) |
Fair Value | 66,885 | 62,633 |
U.S. Government and agency debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 42,514 | 31,866 |
Gross Unrealized Gains | 0 | 30 |
Gross Unrealized Losses | (65) | (10) |
Fair Value | 42,449 | 31,886 |
U.S. Treasury bills | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 24,441 | 30,742 |
Gross Unrealized Gains | 0 | 5 |
Gross Unrealized Losses | (5) | 0 |
Fair Value | $ 24,436 | $ 30,747 |
MEZZANINE EQUITY AND STOCKHOL_2
MEZZANINE EQUITY AND STOCKHOLDERS' EQUITY (Details) | 3 Months Ended | |||||||||
Mar. 01, 2024 USD ($) | Nov. 01, 2023 USD ($) | Oct. 27, 2023 $ / shares shares | Feb. 10, 2023 | Jan. 17, 2023 USD ($) shares | Nov. 14, 2022 USD ($) vote day $ / shares shares | Aug. 12, 2021 USD ($) | Mar. 31, 2024 USD ($) vote $ / shares shares | Dec. 31, 2023 $ / shares shares | Mar. 31, 2023 USD ($) $ / shares shares | |
Class of Stock [Line Items] | ||||||||||
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 | ||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||
Preferred stock, shares issued (in shares) | 0 | 0 | ||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||
Redemption price (percent) | 120% | |||||||||
Common stock shares authorized (in shares) | 150,000,000 | 150,000,000 | ||||||||
Common stock par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||
Reverse stock split ratio | 0.0556 | |||||||||
Proceeds from issuance from secondary offering | $ | $ 0 | $ 156,000 | ||||||||
Outstanding warrants to purchase common stock (in shares) | 27,509 | |||||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 8.40 | |||||||||
Cantor Sales Agreement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued in transaction (in shares) | 34,589 | |||||||||
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 | $ 4.52 | |||||||||
Proceeds from issuance from secondary offering | $ | $ 200,000 | |||||||||
Cowen Sales Agreement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Consideration received in a transaction | $ | $ 50,000,000 | |||||||||
Commission from gross proceeds from issuance of common stock | 3% | |||||||||
Private Placement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued in transaction (in shares) | 10,652,543 | |||||||||
Payments of stock issuance costs | $ | $ 5,500,000 | |||||||||
Consideration received in a transaction | $ | 88,200,000 | |||||||||
Price per share (in dollars per share) | $ / shares | $ 2.245 | |||||||||
Net proceeds from private placement | $ | $ 82,700,000 | |||||||||
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% | |||||||||
Warrants exercised (in shares) | 200,000 | 131,843 | ||||||||
Shares reserved for future issuance (in shares) | 28,282,594 | |||||||||
Common stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of votes entitled to each ordinary share | vote | 1 | |||||||||
Series A Preferred Stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Preferred stock, shares authorized (in shares) | 20,000,000 | |||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||
Preferred stock, shares issued (in shares) | 0 | 0 | ||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||
Number of shares issued in transaction (in shares) | 3,000 | |||||||||
Preferred stock, value, subscriptions | $ | $ 300,000 | |||||||||
Proceeds from subscriptions of preferred stock | $ | $ 211,000 | |||||||||
Convertible preferred stock, shares authorized (in shares) | 3,000 | 3,000 | ||||||||
Convertible preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||||
Number of votes | vote | 1,000,000 | |||||||||
Preferred stock, conversion price (in dollars per share) | $ / shares | $ 4.68 | |||||||||
Number of business days for conversion at option of holder after proposal approval or satisfaction of Nasdaq listing requirements | day | 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 following a delisting event | day | 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 |
STOCK-BASED COMPENSATION - Narr
STOCK-BASED COMPENSATION - Narrative (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares issued during the period (in shares) | 0 | 0 |
Fair value of options and RSUs granted | $ 0 | $ 2,100,000 |
Number of common stock issued per vesting RSU (in shares) | 1 | |
2023 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares reserved for future issuance (in shares) | 120,168 | |
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 | |
2024 Inducement Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares reserved for future issuance (in shares) | 500,000 | |
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% |
STOCK-BASED COMPENSATION - Sche
STOCK-BASED COMPENSATION - Schedule of Options and RSU Grants (Details) | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Granted (in shares) | shares | 575,000 |
Exercise price range (in dollar per share) | $ / shares | $ 2.33 |
Expiration | 10 years |
Options | Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 1 year |
Options | Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 4 years |
RSUs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
RSU, award amount (in shares) | shares | 435,000 |
Exercise price range (in dollar per share) | $ / shares | $ 0 |
Vesting period | 4 years |
STOCK-BASED COMPENSATION - Sc_2
STOCK-BASED COMPENSATION - Schedule of Fair value assumptions (Details) - Options | 3 Months Ended |
Mar. 31, 2024 $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Dividend yield | 0% |
Expected volatility, minimum | 104.63% |
Expected volatility, maximum | 105.71% |
Risk-free interest rate | 3.95% |
Expected term | 6 years |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Fair value of common stock (in usd per share) | $ 1.88 |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Fair value of common stock (in usd per share) | $ 1.94 |
STOCK-BASED COMPENSATION - Sc_3
STOCK-BASED COMPENSATION - Schedule of Share-based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share based compensation expense | $ 985 | $ 856 |
Research and development expenses | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share based compensation expense | 163 | 44 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share based compensation expense | $ 822 | $ 812 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) | Mar. 31, 2024 claim |
Commitments and Contingencies Disclosure [Abstract] | |
Number of claims | 0 |