COVER PAGE
COVER PAGE - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 15, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Current Fiscal Year End Date | --12-31 | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 000-21088 | ||
Entity Registrant Name | FRESH TRACKS THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 93-0948554 | ||
Entity Address, Address Line One | 2000 Central Avenue, | ||
Entity Address, Address Line Two | Suite 100, | ||
Entity Address, City or Town | Boulder, | ||
Entity Address, State or Province | CO | ||
Entity Address, Postal Zip Code | 80301 | ||
City Area Code | 720 | ||
Local Phone Number | 505-4755 | ||
Title of 12(g) Security | Common stock, $0.01 par value per share | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 4.1 | ||
Entity Common Stock, Shares Outstanding | 5,973,306 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE None. | ||
Entity CIK | 0000819050 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2023 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Auditor Information [Abstract] | |
Auditor Firm ID | 42 |
Auditor Name | Ernst & Young LLP |
Auditor Location | Denver, Colorado |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 10,868 | $ 8,680 |
Prepaid expenses and other current assets | 684 | 1,403 |
Total current assets | 11,552 | 10,083 |
Property and equipment, net | 34 | 75 |
Contract asset, net of current portion | 0 | 64 |
Operating lease right-of-use asset | 0 | 49 |
Total assets | 11,586 | 10,271 |
Current liabilities: | ||
Accounts payable | 406 | 571 |
Accrued liabilities | 1,250 | 2,457 |
Lease liability | 0 | 49 |
Total current liabilities | 1,656 | 3,077 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Common stock, $0.01 par value, 300,000,000 shares authorized as of December 31, 2023 and 2022; 5,973,306 and 3,018,940 shares issued and outstanding as of December 31, 2023 and 2022, respectively | 60 | 30 |
Additional paid-in capital | 182,033 | 173,633 |
Accumulated deficit | (172,163) | (166,469) |
Total stockholders’ equity | 9,930 | 7,194 |
Total liabilities and stockholders’ equity | $ 11,586 | $ 10,271 |
CONSOLIDATED BALANCE SHEETS (PA
CONSOLIDATED BALANCE SHEETS (PARENTHETICAL) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 5,973,306 | 3,018,940 |
Common stock, shares outstanding ( in shares ) | 5,973,306 | 3,018,940 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Total revenue | $ 8,006 | $ 6,943 |
Operating expenses: | ||
Research and development | 3,182 | 14,043 |
General and administrative | 11,184 | 14,434 |
Total operating expenses | 14,366 | 28,477 |
Loss from operations | (6,360) | (21,534) |
Other income | 671 | 441 |
Interest expense | (5) | (9) |
Net loss attributable to common stockholders | $ (5,694) | $ (21,102) |
Net loss per common share attributable to common stockholders, basic (in usd per share) | $ (1.06) | $ (7.51) |
Net loss per common share attributable to common stockholders, diluted (in usd per share) | $ (1.06) | $ (7.51) |
Weighted-average shares used to compute net loss per common share attributable to common stockholders, basic (in shares) | 5,394,551 | 2,808,075 |
Weighted-average shares used to compute net loss per common share attributable to common stockholders, diluted (in shares) | 5,394,551 | 2,808,075 |
Contract revenue | ||
Total revenue | $ 8,006 | $ 6,851 |
Royalty revenue | ||
Total revenue | $ 0 | $ 92 |
CONSOLIDATED STATEMENTS OF REDE
CONSOLIDATED STATEMENTS OF REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY - USD ($) $ in Thousands | Total | Series A Redeemable Preferred Stock | Common Stock | Additional Paid-In-Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 0 | ||||
Beginning balance at Dec. 31, 2021 | $ 0 | ||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||
Issuance of redeemable preferred stock (in shares) | 1 | ||||
Redemption of preferred stock (in shares) | (1) | ||||
Ending balance (in shares) at Dec. 31, 2022 | 0 | ||||
Ending balance at Dec. 31, 2022 | $ 0 | ||||
Beginning balance (in shares) at Dec. 31, 2021 | 2,652,828 | ||||
Beginning balance at Dec. 31, 2021 | $ 24,907 | $ 27 | $ 170,247 | $ (145,367) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Common stock issued pursuant to ATM agreements, net of issuance costs (in shares) | 354,381 | ||||
Common stock issued pursuant to ATM agreements, net of issuance costs | 1,196 | $ 3 | 1,193 | ||
Issuance of common stock for cash under employee stock purchase plan (in shares) | 11,731 | ||||
Issuance of common stock for cash under employee stock purchase plan | 37 | 37 | |||
Stock-based compensation | 2,156 | 2,156 | |||
Net loss | $ (21,102) | (21,102) | |||
Ending balance (in shares) at Dec. 31, 2022 | 3,018,940 | 3,018,940 | |||
Ending balance at Dec. 31, 2022 | $ 7,194 | $ 30 | 173,633 | (166,469) | |
Ending balance (in shares) at Dec. 31, 2023 | 0 | ||||
Ending balance at Dec. 31, 2023 | $ 0 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Common stock issued pursuant to ATM agreements, net of issuance costs (in shares) | 2,887,535 | ||||
Common stock issued pursuant to ATM agreements, net of issuance costs | 6,569 | $ 29 | 6,540 | ||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes (in shares) | 66,831 | ||||
Issuance of common stock upon restricted stock unit settlement, net of shares withheld for taxes | (38) | $ 1 | (39) | ||
Repurchase of restricted stock units | (20) | (20) | |||
Stock-based compensation | 1,919 | 1,919 | |||
Net loss | $ (5,694) | (5,694) | |||
Ending balance (in shares) at Dec. 31, 2023 | 5,973,306 | 5,973,306 | |||
Ending balance at Dec. 31, 2023 | $ 9,930 | $ 60 | $ 182,033 | $ (172,163) |
CONSOLIDATED STATEMENTS OF RE_2
CONSOLIDATED STATEMENTS OF REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (PARENTHETICAL) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Statement of Stockholders' Equity [Abstract] | ||
Stock issuance costs | $ 202 | $ 117 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (5,694) | $ (21,102) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,919 | 2,156 |
Non-cash operating lease expense | 60 | 59 |
Depreciation | 41 | 30 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets, including noncurrent portion of contract asset | 783 | 1,249 |
Accounts payable | (165) | (1,034) |
Accrued liabilities | (1,227) | (624) |
Operating lease liability | (60) | (69) |
Net cash used in operating activities | (4,343) | (19,335) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Capital expenditures | 0 | (47) |
Net cash used in investing activities | 0 | (47) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of common stock pursuant to ATM agreement, net of issuance costs | 6,569 | 1,196 |
Payments of taxes related to net share settlement of equity awards | (38) | (55) |
Proceeds from the issuance of common stock under employee stock purchase plan | 0 | 37 |
Net cash provided by financing activities | 6,531 | 1,178 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 2,188 | (18,204) |
CASH AND CASH EQUIVALENTS—BEGINNING | 8,680 | 26,884 |
CASH AND CASH EQUIVALENTS—ENDING | 10,868 | 8,680 |
Supplemental Disclosure of Non-Cash Investing and Financing Activities: | ||
Acquisition of right-of-use asset through lease liability | $ 11 | $ 49 |
ORGANIZATION AND NATURE OF OPER
ORGANIZATION AND NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND NATURE OF OPERATIONS | ORGANIZATION AND NATURE OF OPERATIONS On September 19, 2023, Fresh Tracks Therapeutics, Inc. (the “Company” or “Fresh Tracks”) announced a proposed plan of liquidation and dissolution (the “Plan of Dissolution”) and its intent to discontinue all clinical and preclinical development programs and reduce its workforce. Historically, the Company was a clinical-stage pharmaceutical company striving to transform patient lives through the development of innovative and differentiated prescription therapeutics. The Company’s pipeline aimed to disrupt existing treatment paradigms and featured several new chemical entities that inhibit novel targets with first-in-class potential for autoimmune, inflammatory, and other debilitating diseases. In connection with the Plan of Dissolution, effective October 2, 2023, the Company discontinued all clinical and preclinical development programs and terminated most of its employees, except for certain employees, consultants, and advisors who will supervise and facilitate the dissolution and wind down of the Company. Liquidity and Capital Resources The Company has incurred significant operating losses and has an accumulated deficit as a result of in-licensing and development of product candidates, including conducting preclinical and clinical trials and providing general and administrative support for these operations. For the year ended December 31, 2023, the Company had a net loss of $5.7 million and net cash used in operating activities of $4.3 million. As of December 31, 2023, the Company had cash and cash equivalents of $10.9 million and an accumulated deficit of $172.2 million. The Company expects to continue to incur additional losses for the foreseeable future as it implements the Plan of Dissolution. During the year ended December 31, 2023, the Company’s board of directors (“Board”) and executive management team conducted a comprehensive process to explore and evaluate strategic alternatives with the goal of maximizing stockholder value. Potential alternatives that were under evaluation included, but were not limited to, a financing, a merger or reverse merger, the sale of all or part of the Company, licensing of assets, a business combination, and/or other strategic transactions or series of related transactions involving the Company. On September 18, 2023, the Board unanimously approved the liquidation and dissolution of the Company (the “Dissolution”) and the Plan of Dissolution, subject to the approval of the Company’s stockholders. The Company held special meetings of stockholders on November 16, 2023, November 30, 2023, December 15, 2023, December 27, 2023, and February 15, 2024 (the “Special Meetings”) to seek stockholder approval of the Dissolution and the Plan of Dissolution. However, the Dissolution and Plan of Dissolution did not receive the affirmative vote of a majority of the outstanding shares of the Company’s common stock entitled to vote at the Special Meetings, and as a result, the Company intends to continue to seek approval to dissolve and distribute all remaining cash to stockholders over time. As a result of the Plan of Dissolution, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of twelve months from the date of issuance of the consolidated financial statements, which do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty about the ability to continue as a going concern. Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. If the Company obtains approval to dissolve and the likelihood is remote that the Company would return from liquidation, the Company would consider liquidation to be imminent and apply liquidation basis of accounting. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Brickell Subsidiary, Inc. (“Brickell Subsidiary”), and are presented in United States (“U.S.”) dollars and prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), which include all adjustments necessary for the fair presentation of the Company’s financial position, results of operations, and cash flows for the periods presented. All significant intercompany balances have been eliminated in consolidation. The Company operates in one operating segment and, accordingly, no segment disclosures have been presented herein. Use of Estimates The Company’s consolidated financial statements are prepared in accordance with U.S. GAAP, which requires it 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 financial statements and the reported amounts of revenue and expenses during the reporting period. Although these estimates are based on the Company’s knowledge of current events and actions it may take in the future, actual results may ultimately differ from these estimates and assumptions. Risks and Uncertainties The Company’s business is subject to significant risks, including, but not limited to, uncertainty of plans and expectations for the Dissolution and the Plan of Dissolution and the scope, timing, rate of progress, and expense of the Company’s ongoing and future activities ; the ongoing liquidity of the Company’s outstanding common stock; the Company’s ability, if there is interest from potential purchasers, to sell any of its assets as part of the Plan of Dissolution, including but not limited to independently developed data packages, technology, and other intellectual property; compliance with regulatory and other legal requirements; and ability to manage business partners and other alliances, including potential return of product licenses and termination of these and other existing contractual relationships with the Company. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less from date of purchase to be cash equivalents. Cash equivalents consist primarily of amounts held in short-term money market accounts with highly rated financial institutions. Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains cash and cash equivalents balances in several accounts with one financial institution which, from time to time, are in excess of federally insured limits. One third party individually accounted for all of the Company’s revenue for the years ended December 31, 2023 and 2022, as well as associated accounts receivable and contract asset balances as of December 31, 2022. Refer to Note 3. “Strategic Agreements ” for a detailed discussion of agreements with Botanix SB Inc. and Botanix Pharmaceuticals Limited (“Botanix”) and the termination of the Company’s future payment rights in exchange for a single up-front payment in the year ended December 31, 2023. Property and Equipment Property and equipment is stated at cost, less accumulated depreciation. Expenditures for major betterments and additions are charged to the asset accounts, while replacements, maintenance, and repairs, which do not improve or extend the lives of the respective assets, are charged to expense as incurred. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three Fair Value Measurements Fair value is the price that the Company would receive to sell an asset or pay to transfer a liability in a timely transaction with an independent counterparty in the principal market, or in the absence of a principal market, the most advantageous market for the asset or liability. A three-tier hierarchy distinguishes between (1) inputs that reflect the assumptions market participants would use in pricing an asset or liability developed based on market data obtained from sources independent of the reporting entity (observable inputs) and (2) inputs that reflect the reporting entity’s own assumptions about the assumptions market participants would use in pricing an asset or liability developed based on the best information available in the circumstances (unobservable inputs). The hierarchy is summarized in the three broad levels listed below: Level 1 —quoted prices in active markets for identical assets and liabilities Level 2 —other significant observable inputs (including quoted prices for similar assets and liabilities, interest rates, credit risk, etc.) Level 3 —significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities) The following table sets forth the fair value of the Company’s financial assets measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands): Level 1 December 31, 2023 2022 Money market funds $ 10,617 $ 7,680 Fair Value of Financial Instruments The following methods and assumptions were used by the Company in estimating the fair values of each class of financial instrument disclosed herein: Money Market Funds— The carrying amounts reported as cash equivalents in the consolidated balance sheets approximate their fair values due to their short-term nature and market rates of interest. The carrying values of cash equivalents, accounts receivable, accounts payable, and accrued liabilities approximate fair value due to the short-term maturity of those items. Revenue Recognition The Company has historically recognized revenue primarily from upfront fees, research and development milestones, research reimbursements, and consulting services fees related to the development of previously owned or sublicensed assets associated with the proprietary compound sofpironium bromide, as well as sublicense income and royalty fees on sales of sofpironium bromide gel, 5% (ECCLOCK ® ) in Japan. The Company recognizes revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. In determining the appropriate amount of revenue to be recognized, 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, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company utilizes judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Contract Revenue The Company evaluates its contracts, including asset sale arrangements that involve the Company’s rights to intellectual property, to determine whether they are outputs of the Company’s ordinary activities and whether the counterparty meets the definition of a customer. If the arrangement is determined to be a contract with a customer and the goods or services sold are determined to be distinct from other performance obligations identified in the arrangement, the Company recognizes revenue primarily from non-refundable upfront fees, milestone payments, sales-based payments, and fees for consulting services allocated to the goods or services when (or as) control is transferred to the customer, and the customer can use and benefit from the goods or services. Licenses of Intellectual Property If a license for the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue when the functional license is transferred to the customer, and the customer can use and benefit from the license. Milestones At the inception of each arrangement that includes milestone payments (variable consideration), excluding sales-based milestone payments discussed below, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. The most likely amount method is generally utilized when there are only two possible outcomes and represents the Company’s best estimate of the single most likely outcome to be achieved. If it is probable that a significant revenue reversal would not occur, the variable consideration for the associated milestone is included in the transaction price. Milestone payments contingent on regulatory approvals that are not within the Company or the Company’s collaboration partner’s control, as applicable, are generally not considered probable of being achieved until those approvals are received. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the variable consideration. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue in the period of adjustment. Sales-Based Payments For license arrangements that include sales-based payments such as royalties or milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the sales-based payments relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the sales-based payment has been allocated has been satisfied (or partially satisfied). Sales-based payments received under license arrangements are recorded as royalty revenue in the Company’s consolidated statements of operations. For non-license arrangements that include sales-based payments, including earnout payments and milestone payments based on the level of sales, the Company estimates the sales-based payments (variable consideration) to be achieved and recognizes revenue to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The Company may use either the most likely amount, as described above, or the expected value method, in making such estimates based on the nature of the payment to be received and whether there is a wide range of outcomes or only two possible outcomes. The expected value method represents the sum of probability-weighted amounts in a range of possible consideration amounts. The Company bases its estimates using the applicable method described above on factors such as, but not limited to, required regulatory approvals, historical sales levels, market events and projections, and other factors as appropriate. The Company updates its estimates at each reporting period based on actual results and future expectations as necessary. Contract Asset For non-license arrangements involving the sale and transfer of the Company’s intellectual property rights, the Company recognizes estimated variable consideration as revenue as discussed above before the customer pays consideration or before payment is due. The estimated revenue recognized is presented as a contract asset on the Company’s consolidated balance sheets. The current portion of the contract asset is presented in prepaid expenses and other current assets on the Company’s consolidated balance sheets. Actual amounts paid or due by the customer are recorded as a reduction to the contract asset. Any revisions to the Company’s estimated revenue based on actual results and future expectations are recognized as an adjustment to the contract asset. Research and Development Research and development costs are charged to expense when incurred and consist of costs incurred for independent and collaboration research and development activities. The major components of research and development costs include formulation development, nonclinical studies, clinical studies, clinical manufacturing costs, in-licensing fees for development-stage assets, salaries and employee benefits, and allocations of various overhead and occupancy costs. Research costs typically consist of applied research, preclinical, and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis, and the transfer and scale-up of manufacturing at contract manufacturers. Assets acquired (or in-licensed) that are utilized in research and development that have no alternative future use are expensed as incurred. Milestone payments related to the Company’s acquired (or in-licensed) assets are recorded as research and development expenses when probable and reasonably estimable. Costs for certain research and development activities, such as clinical trial expenses, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, and information provided to the Company by its vendor on their actual costs incurred or level of effort expended. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as prepaid expenses and other current assets or accrued expenses. When the Company enters into licensing or subscription arrangements to access and utilize certain technology, the Company evaluates if the license agreement results in the acquisition of an asset or a business. To date, none of the Company’s license agreements have been considered an acquisition of a business. For asset acquisitions, the upfront payments to acquire such licenses, as well as any future milestone payments made before product approval that do not meet the definition of a derivative, are immediately recognized as research and development expenses when they are paid or become payable, provided there is no alternative future use of the rights in other research and development projects. Net Loss per Share Basic and diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing the Company’s net income by the weighted-average number of common shares outstanding and the impact of all potentially dilutive common shares. Diluted net loss per share is the same as basic net loss per share, as the effects of potentially dilutive securities are anti-dilutive for all periods presented. The following table sets forth the potential common shares excluded from the calculation of diluted net loss per share because their inclusion would be anti-dilutive: Year Ended 2023 2022 Outstanding common stock warrants 621,063 621,063 Outstanding options — 215,316 Total 621,063 836,379 Leases The Company determines if an arrangement is a lease at inception. Operating leases with a term greater than one year are recognized on the consolidated balance sheets as right-of-use assets and lease liabilities. The Company does not hold any finance leases. The Company has elected the practical expedient not to recognize on the consolidated balance sheets leases with terms of one year or less and not to separate lease components and non-lease components for real estate leases. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company estimates the incremental borrowing rate in determining the present value of lease payments. Lease expense is recognized on a straight-line basis over the lease term. Redeemable Preferred Stock The Company issued one share of redeemable preferred stock in May 2022. The redeemable preferred stock contained provisions that required redemption under circumstances that were outside of the Company’s control and was classified as a mezzanine instrument outside of the Company’s capital accounts. The share of redeemable preferred stock was sold to one investor for $10 and was subsequently redeemed in July 2022, as described further in Note 6. “ Capital Stock. ” Income Taxes The Company accounts for income taxes by using an asset and liability method of accounting for deferred income taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financ ial statement carrying amounts of existing assets and liabilities and their respective tax bases. A valuation allowance is recorded to the extent it is more likely than not that a deferred tax asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. The Company’s significant deferred tax assets are for net operati ng loss (“NOL”) carryforwards, ta x credits, fixed assets, and intangible assets. The Company has provided a valuation allowance for its entire net deferred tax assets since inception because, due to its history of operating losses, the Company has concluded that it is more likely than not that its deferred tax assets will not be realized. The Company recognizes interest and penalties arising from the underpayment of income taxes in the consolidated statements of operations as a component of income tax expense. The Company had no accrual for interest or penalties on its consolidated balance sheets as of December 31, 2023 and 2022, and has not recognized interest or penalties in its consolidated statements of operations for the years ended December 31, 2023 and 2022. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards has had or will have a material impact on the Company’s consolidated financial statements or disclosures. |
STRATEGIC AGREEMENTS
STRATEGIC AGREEMENTS | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
STRATEGIC AGREEMENTS | STRATEGIC AGREEMENTS License and Development Agreement with Voronoi On August 27, 2021, the Company entered into a License and Development Agreement (the “Voronoi License Agreement”) with Voronoi Inc. (“Voronoi”), pursuant to which the Company acquired exclusive, worldwide rights to research, develop, and commercialize FRTX-02 and other next-generation kinase inhibitors. With respect to FRTX-02, the Voronoi License Agreement provides that the Company will make payments to Voronoi of up to $211.0 million in the aggregate contingent upon achievement of specified development, regulatory, and commercial milestones. With respect to the compounds arising from the next-generation kinase inhibitor platform, the Company will make payments to Voronoi of up to $107.5 million in the aggregate contingent upon achievement of specified development, regulatory, and commercial milestones. Further, the Voronoi License Agreement provides that the Company will pay Voronoi tiered royalty payments ranging from low-single digits up to 10% of net sales of products arising from the DYRK1A inhibitor programs and next-generation kinase inhibitor platform. All of the contingent payments and royalties are payable in cash in U.S. Dollars, except for $1.0 million of the development and regulatory milestone payments, which amount is payable in equivalent shares of the Company’s common stock. Under the terms of the Voronoi License Agreement, the Company is responsible for, and bears the future costs of, all development and commercialization activities, including the first right to prosecute and maintain patents, related to all the licensed compounds. As of December 31, 2023 and through the date of this Annual Report, the Company has not yet made any payments or recorded any liabilities related to the specified development, regulatory, and commercial milestones or royalties on net sales pursuant to the Voronoi License Agreement. The Voronoi License Agreement also provides that upon termination of the Voronoi License Agreement, Voronoi will be entitled to receive a non-exclusive license to any information and know-how independently developed by the Company for FRTX-02 and other licensed assets in consideration for payment(s) at an arms’-length royalty rate on net sales that must be negotiated in good faith between the parties. Exclusive License and Development Agreement with Carna On February 2, 2022, the Company entered into an Exclusive License Agreement (the “Carna License Agreement”) with Carna Biosciences, Inc. (“Carna”), pursuant to which the Company acquired exclusive, worldwide rights to research, develop, and commercialize Carna’s portfolio of novel STING inhibitors. In accordance with the terms of the Carna License Agreement, in exchange for the licens ed rights, the Company made a one -time cash payment of $2.0 million, which was recorded as research and development expenses in the consolidated statements of operations during the year ended December 31, 2022. The Carna License Agreement provided that the Company would make success-based payments to Carna of up to $258.0 million in the aggregate contingent upon achievement of specified development, regulatory, and commercial milestones. Further, the Carna License Agreement provided that the Company would pay Carna tiered royalty payments ranging from mid-single digits up to 10% of net sales. Under the terms of the Carna License Agreement, the Company was responsible for all development and commercialization activities, including patenting, related to all the licensed compounds. As of December 31, 2023 and through the date of this Annual Report, the Company has not made any payments or recorded any liabilities related to the specified development, regulatory, and commercial milestones or royalties on net sales pursuant to the Carna License Agreement. Effective March 1, 2024, the Carna License Agreement was terminated by mutual agreement. Agreements with Botanix Asset Purchase Agreement with Botanix On May 3, 2022 (the “Effective Date”), the Company and Brickell Subsidiary entered into an asset purchase agreement with Botanix (the “Asset Purchase Agreement”), pursuant to which Botanix acquired and assumed control of all rights, title, and interests to assets primarily related to the proprietary compound sofpironium bromide that were owned and/or licensed by the Company or Brickell Subsidiary (the “Assets”). Prior to the sale of the Assets, the Company had previously entered into a License Agreement with Bodor Laboratories, Inc. (“Bodor”), dated December 15, 2012 (last amended in February 2020) that provided the Company with a worldwide exclusive license to develop, manufacture, market, sell, and sublicense products containing sofpironium bromide through which the Assets were developed (the “Amended and Restated License Agreement”). As a result of the Asset Purchase Agreement, Botanix became responsible for all further research, development, and commercialization of sofpironium bromide globally and replaced the Company as the exclusive licensee under the Amended and Restated License Agreement. In accordance with the sublicense rights provided to the Company under the Amended and Restated License Agreement, the Company also had previously entered into a License, Development, and Commercialization Agreement with Kaken Pharmaceutical Co., Ltd. (“Kaken”), dated as of March 31, 2015 (as amended in May 2018, the “Kaken Agreement”), under which the Company granted to Kaken an exclusive right to develop, manufacture, and commercialize the sofpironium bromide compound in Japan and certain other Asian countries (the “Territory”). In exchange for the sublicense, the Company was entitled to receive aggregate payments of up to $10.0 million upon the achievement of specified development milestones, which were earned and received in 2017 and 2018, and up to $19.0 million upon the achievement of sales-based milestones, as well as tiered royalties based on a percentage of net sales of licensed products in the Territory. In September 2020, Kaken received regulatory approval in Japan to manufacture and market ECCLOCK for the treatment of primary axillary hyperhidrosis, and as a result, the Company began recognizing royalty revenue earned on a percentage of net sales of ECCLOCK in Japan. Pursuant to the Asset Purchase Agreement, the Kaken Agreement was assigned to Botanix, which replaced the Company as the exclusive sub-licensor to Kaken. During the year ended December 31, 2022, prior to entering into the Asset Purchase Agreement, the Company recognized royalty revenue under the Kaken Agreement of $0.1 million. The Company determined that the development of and ultimate sale and assignment of rights to the Assets is an output of the Company’s ordinary activities and Botanix is a customer as it relates to the sale of the Assets and related activities. On July 21, 2023, the Company and Brickell Subsidiary entered into Amendment No. 1 to the Asset Purchase Agreement (the “Asset Purchase Agreement Amendment”) with Botanix. The Asset Purchase Agreement Amendment provided that, in lieu of any remaining amounts potentially payable by Botanix to the Company pursuant to the Asset Purchase Agreement (collectively, the “Post-Closing Payment Obligations”), Botanix would pay $6.6 million to the Company and $1.7 million on behalf of the Company to Bodor. The payments from Botanix to the Company and Bodor were made on July 26, 2023. The Asset Purchase Agreement Amendment also provided that upon payment of the amounts by Botanix thereunder, all Post-Closing Payment Obligations under the Asset Purchase Agreement were terminated and of no further force or effect. In accordance with the terms of the Asset Purchase Agreement, in exchange for the Assets, the Company (i) received an upfront payment at closing in the amount of $3.0 million, (ii) was reimbursed for certain recent development expenditures in advancement of the Assets, (iii) received a milestone payment of $2.0 million upon the acceptance by the U.S. Food and Drug Administration (“FDA”) in December 2022 of the filing of a new drug application (“NDA”) for sofpironium bromide gel, 15%, and (iv) would have been eligible to receive, prior to the Asset Purchase Agreement Amendment, a contingent milestone payment of $4.0 million if marketing approval in the U.S. for sofpironium bromide gel, 15%, had been received on or before September 30, 2023, or $2.5 million if such marketing approval had been received after September 30, 2023 but on or before February 17, 2024. Botanix submitted an NDA for sofpironium bromide gel, 15%, to the FDA in September 2022, which was accepted for filing by the FDA in December 2022. Under the Asset Purchase Agreement, the Company also would have been eligible to receive, prior to the Asset Purchase Agreement Amendment, additional success-based regulatory and sales milestone payments of up to $168.0 million. Further, the Company would have been eligible to receive, prior to the Asset Purchase Agreement Amendment, tiered earnout payments ranging from high-single digits to mid-teen digits on net sales of sofpironium bromide gel (the “Earnout Payments”). The Asset Purchase Agreement also provided that Botanix would pay the Company a portion of the sales-based milestone payments and royalties that Botanix received from Kaken under the assigned Kaken Agreement (together, the “Sublicense Income”). Sublicense Income represented the Company’s estimate of payments that would be earned by the Company in the applicable period from sales-based milestone payments and royalties Botanix would receive from Kaken to the extent it was probable that a significant reversal in the amount of cumulative revenue recognized would not occur. Royalties vary based on net sales that are impacted by a wide variety of market and other factors and, as such, the Company utilized the expected value approach, which the Company believed would best predict the amount of consideration to which it would be entitled. In relation to the sales-based milestone payments that Botanix could receive from Kaken in the future, the Company utilized the most likely amount method and determined it was not yet probable that the Company would receive any payments from Botanix in relation to such milestone payments. Therefore, the Company determined that such milestone payments were fully constrained up through the date of the Asset Purchase Agreement Amendment, and, as such, did not recognize such amounts as contract revenue. With respect to the recognition of contract revenue for the Sublicense Income based on future royalties that would be due to Botanix from Kaken, certain amounts were not yet due from Botanix. Therefore, the Company recorded a contract asset equal to the amount of revenue recognized related to the Sublicense Income, less the amount of payments received from or due by Botanix in relation to the Sublicense Income. As a result of entering into the Asset Purchase Agreement Amendment, the contract asset was fully settled. All other consideration due under the Asset Purchase Agreement was contingent upon certain regulatory approvals and future sales subsequent to such regulatory approvals, or was based upon future sales that the Company determined were not yet probable due to such revenues being highly susceptible to factors outside of the Company’s influence and uncertainty about the amount of such consideration that would not be resolved for an extended period of time. Therefore, the Company determined that such variable consideration amounts were fully constrained up through the date of the Asset Purchase Agreement Amendment, and as such, did not recognize such amounts as contract revenue. Transition Services Agreement with Botanix In connection with the sale of the Assets, on the Effective Date, the Company and Botanix entered into a transition services agreement (the “TSA”) whereby the Company provides consulting services as an independent contractor to Botanix in support of and through filing and potential approval of the U.S. NDA for sofpironium bromide gel, 15%. In accordance with the terms of the TSA, in exchange for providing these services (i) prior to the acceptance of the filing by the FDA of such NDA in December 2022, the Company received from Botanix a fixed monthly amount of $71 thousand, and (ii) after the acceptance of the filing in December 2022, the Company receives from Botanix a variable amount based upon actual hours worked, in each case plus related fees and expenses of the Company’s advisors (plus a 5% administrative fee) and the Company’s out-of-pocket expenses. Contract Revenue and Contract Asset under the Botanix Agreements The Company recognized the following as contract revenue (in thousands): Year Ended 2023 2022 Buyout of Post-Closing Payment Obligations $ 7,944 $ — Sublicense Income 53 433 Consulting services provided under the TSA 9 794 Upfront consideration — 3,000 Milestone payment received upon acceptance by FDA of NDA filing — 2,000 Reimbursed development expenditures under the Asset Purchase Agreement — 624 Total contract revenue $ 8,006 $ 6,851 The following table presents changes in the value of the Company’s contract asset related to Sublicense Income for the following periods (in thousands): Contract asset as of January 1, 2023 $ 318 Amounts received (318) Contract asset as of December 31, 2023 $ — Contract asset as of January 1, 2022 $ — Sublicense Income recognized 433 Amounts received or receivable (115) Contract asset as of December 31, 2022 $ 318 Contract asset, included in prepaid expenses and other current assets $ 254 Contract asset, net of current portion $ 64 Agreements with Bodor In connection with the sale of the Assets, on the Effective Date, the Company, Brickell Subsidiary, and Bodor entered into an agreement (the “Rights Agreement”) to clarify that the Company and Brickell Subsidiary have the power and authority under the Amended and Restated License Agreement to enter into the Asset Purchase Agreement and the TSA, and that Botanix would assume the Amended and Restated License Agreement pursuant to the Asset Purchase Agreement. The Rights Agreement included a general release of claims and no admission of liability between the parties. Pursuant to such Rights Agreement, as subsequently amended on November 10, 2022, the Company agreed to pay Bodor (i) 20% of the amount of each payment due to the Company from Botanix for upfront and milestone payments, subject to deductions, credits, or offsets applied under the Asset Purchase Agreement, as well as (ii) certain tiered payments, set as a percentage ranging from mid-single digits to mid-teen digits, of the amount of each of the applicable Earnout Payments due to the Company from Botanix after deductions, credits or offsets applied under the Asset Purchase Agreement. Pursuant to the terms of the Asset Purchase Agreement, the Company retained its obligation under the Amended and Restated License Agreement to issue $1.0 million in shares of its common stock to Bodor upon the FDA’s acceptance of an NDA filing for sofpironium bromide gel, 15%. On November 10, 2022, the Company entered into an Acknowledgment and Agreement Related to Asset Purchase Agreement and Amended and Restated License Agreement (the “Acknowledgment”) with Brickell Subsidiary, Botanix, and Bodor. Pursuant to the Acknowledgment, the Company paid $1.0 million in cash to Bodor in full satisfaction of the Company’s obligation to issue shares upon the FDA’s acceptance of the NDA. In connection with the Asset Purchase Agreement Amendment, on July 21, 2023, the Company, Brickell Subsidiary, and Bodor entered into a Second Amendment to Rights Agreement (the “RA Amendment”). The RA Amendment provides that in exchange for the one-time payment of $1.7 million by Botanix on behalf of the Company to Bodor, the Company shall have no further payment obligations to Bodor under or in connection with the Rights Agreement or the Amended and Restated License Agreement. |
DETAILED ACCOUNT BALANCES
DETAILED ACCOUNT BALANCES | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
DETAILED ACCOUNT BALANCES | DETAILED ACCOUNT BALANCES Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2023 2022 Prepaid insurance $ 545 $ 521 Accounts receivable 45 250 Contract asset — 254 Prepaid research and development expenses — 254 Other 94 124 Total $ 684 $ 1,403 Accrued liabilities consisted of the following (in thousands): December 31, 2023 2022 Accrued severance $ 1,018 $ — Accrued compensation 232 1,320 Accrued professional fees — 705 Accrued research and development expenses — 432 Total $ 1,250 $ 2,457 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Operating Lease In August 2016, the Company entered into a multi-year, noncancelable lease for its Colorado-based office space, which was amended on December 29, 2022 to, among other things, extend the lease term to December 31, 2025, eliminate options previously available to the Company to extend the lease, and provide that the Company may terminate the lease effective June 30, 2023 if notice is provided by April 30, 2023 (as amended, the “Boulder Lease”). Minimum base lease payments under the Boulder Lease were recognized on a straight-line basis over the term of the lease. In addition to base rental payments included in the contractual obligations table below, the Company was responsible for its pro rata share of the operating expenses for the building, which included common area maintenance, utilities, property taxes, and insurance. Upon modification of the Boulder Lease in December 2022, the Company reassessed classification of the lease and determined that the lease still met the criteria to be classified as an operating lease. Furthermore, the Company remeasured the lease liability as of the effective date by calculating the present value of the new lease payments, discounted at the Company’s incremental borrowing rate, over the lease term of six months. The lease term included periods covered by an option to terminate the lease that the Company was reasonably certain to exercise. The operating expenses were variable and were not included in the present value determination of the lease liability. On May 4, 2023, the Company entered into an amendment to the Boulder Lease, which terminated the Boulder Lease, effective August 31, 2023, and provided for the payment of a termination fee by the Company of approximately $5 thousand in May 2023. Upon modification of the Boulder Lease, the Company reassessed classification of the lease and determined that the lease still met the criteria to be classified as an operating lease. Furthermore, the Company remeasured the lease liability as of the effective date by calculating the present value of the new lease payments, discounted at the Company’s incremental borrowing rate, over the remaining lease term of four months. The operating expenses were variable and were not included in the present value determination of the lease liability. As of December 31, 2023, the Company had no contractual obligations related to operating lease commitments. The following table presents information pertaining to the Company’s former operating leases (in thousands): Year Ended 2023 2022 Operating lease cost $ 67 $ 62 Variable lease cost $ 20 $ 39 Cash outflows from operating leases $ 81 $ 111 Weighted-average remaining lease term — years 0.5 years Weighted-average discount rate 11.0 % 11.0 % Licensing and Other Agreements Refer to Note 3. “ Strategic Agreements ” for more information about the Company’s obligations under its licensing and other agreements. |
CAPITAL STOCK
CAPITAL STOCK | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
CAPITAL STOCK | CAPITAL STOCK Common Stock Under the Company’s Restated Certificate of Incorporation, the Company’s Board has the authority to issue up to 300,000,000 shares of common stock with a par value of $0.01 per share. Each share of the Company’s common stock is entitled to one vote, and the holders of the Company’s common stock are entitled to receive dividends when and as declared or paid by its Board. The Company had reserved authorized shares of common stock for future issuance as of December 31, 2023 as follows: December 31, Common stock warrants 621,063 Public Offerings of Common Stock and Warrants In October 2020, the Company completed a sale of 422,300 shares of its common stock, and, to certain investors, pre-funded warrants to purchase 40,663 shares of its common stock and accompanying common stock warrants to purchase up to an aggregate of 462,979 shares of its common stock (the “October 2020 Offering”). Each share of common stock and pre-funded warrant to purchase one share of the Company’s common stock was sold together with a common warrant to purchase one share of the Company’s common stock. The shares of common stock and pre-funded warrants, and the accompanying common warrants, were issued separately and were immediately separable upon issuance. The common warrants are exercisable at a price of $32.40 per share of the Company’s common stock and will expire five years from the date of issuance. The common warrants provide the warrant holder with the right to participate in distributions on a 1-for-1 basis with common shareholders. The pre-funded warrants were exercised in October 2020. No warrants associated with the October 2020 Offering were exercised during the years ended December 31, 2023 or 2022. In June 2020, the Company completed a sale of 328,669 shares of its common stock, and, to certain investors, pre-funded warrants to purchase 60,220 shares of its common stock and accompanying common stock warrants to purchase up to an aggregate of 388,920 shares of its common stock (the “June 2020 Offering”). Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together with a common warrant to purchase one share of common stock. The shares of common stock and pre-funded warrants, and the accompanying common warrants, were issued separately and were immediately separable upon issuance. The pre-funded warrants were exercised in the third quarter of 2020. The common warrants were immediately exercisable at a price of $56.25 per share of common stock and will expire five years from the date of issuance. The common warrants provide the warrant holder with the right to participate in distributions on a 1-for-1 basis with common shareholders. No warrants associated with the June 2020 Offering were exercised during the years ended December 31, 2023 or 2022. At Market Issuance Sales Agreements In March 2021, the Company entered into an At Market Issuance Sales Agreement (the “2021 ATM Agreement”) with Oppenheimer & Co. Inc. (“Oppenheimer”) and William Blair & Company, L.L.C. as the Company’s sales agents (the “Agents”). The 2021 ATM Agreement was subsequently terminated effective December 22, 2023. Pursuant to the terms of the 2021 ATM Agreement, the Company could sell from time to time through the Agents shares of its common stock having an aggregate offering price of up to $50.0 million. Sales of shares were made by means of ordinary brokers’ transactions on The Nasdaq Capital Market at market prices or as otherwise agreed by the Company and the Agents. Under the terms of the 2021 ATM Agreement, the Company could also sell the shares from time to time to an Agent as principal for its own account at a price to be agreed upon at the time of sale. Any sale of the shares to an Agent as principal would have been sold pursuant to the terms of a separate placement notice between the Company and such Agent. During the year ended December 31, 2023, the Company sold 2,887,535 shares of common stock under the 2021 ATM Agreement at a weighted-average price of $2.34 per share, for aggregate net proceeds of $6.6 million, after giving effect to a 3% commission to the Agents. During the year ended December 31, 2022, the Company sold 354,381 shares of common stock under the 2021 ATM Agreement at a weighted-average price of $3.70 per share, for aggregate net proceeds of $1.3 million, after giving effect to a 3% commission to the Agents. As of the date the 2021 ATM Agreement was terminated, approximately $38.0 million of shares of common stock were remaining, but had not yet been sold by the Company under the 2021 ATM Agreement. In April 2020, the Company entered into an At Market Issuance Sales Agreement (the “2020 ATM Agreement”) with Oppenheimer as the Company’s sales agent. The 2020 ATM Agreement was subsequently terminated effective December 22, 2023. Pursuant to the terms of the 2020 ATM Agreement, the Company could sell from time to time through Oppenheimer shares of its common stock having an aggregate offering price of up to $8.0 million. During the years ended December 31, 2023 and 2022, no sales of common stock under the 2020 ATM Agreement occurred. As of the date the 2020 ATM Agreement was terminated, approximately $2.6 million of shares of common stock were remaining, but had not yet been sold by the Company under the 2020 ATM Agreement. Private Placement Offerings In February 2020, the Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into (i) a securities purchase agreement (the “Securities Purchase Agreement”); (ii) a purchase agreement (the “Purchase Agreement”); and (iii) a registration rights agreement. Pursuant to the Securities Purchase Agreement, Lincoln Park purchased, and the Company sold, (i) an aggregate of 21,111 shares of common stock (the “Common Shares”); (ii) a warrant to initially purchase an aggregate of up to 13,476 shares of common stock at an exercise price of $0.45 per share (the “Series A Warrant”); and (iii) a warrant to initially purchase an aggregate of up to 34,588 shares of common stock at an exercise price of $52.20 per share (the “Series B Warrant” and, together with the Series A Warrant, the “Warrants”). The Warrants provide the warrant holder with the right to participate in distributions on a 1-for-1 basis with common shareholders. No Warrants associated with the Securities Purchase Agreement were exercised during the years ended December 31, 2023 or 2022. Under the terms and subject to the conditions of the Purchase Agreement, the Company had the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park was obligated to purchase, up to $28.0 million in the aggregate of shares of common stock. On September 1, 2023, the Purchase Agreement expired according to its terms. During the years ended December 31, 2023 and 2022, no sales of common stock under the Purchase Agreement occurred. Preferred Stock Under the Company’s Restated Certificate of Incorporation, the Company’s Board has the authority to issue up to 5,000,000 shares of preferred stock with a par value of $0.01 per share, at its discretion, in one or more classes or series and to fix the powers, preferences and rights, and the qualifications, limitations, or restrictions thereof, including dividend rights, conversion rights, voting rights, terms of redemption, and liquidation preferences, without further vote or action by the Company’s stockholders. On May 25, 2022, the Company issued and sold one share of the Company’s preferred stock, which was designated as Series A Preferred Stock (the “Series A Preferred Stock”), for a nominal amount. During the time the Series A Preferred Stock was outstanding, it had 80,000,000 votes exclusively with respect to any proposal to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of the Company’s common stock. The terms of the Series A Preferred Stock provided that it would be voted, without action by the holder, on any such proposal in the same proportion as shares of the Company’s common stock were voted. The Series A Preferred Stock otherwise had no voting rights except as otherwise required by the General Corporation Law of the State of Delaware. The Series A Preferred Stock was not convertible into, or exchangeable for, shares of any other class or series of stock or other securities of the Company and had no rights with respect to any distribution of assets of the Company, including upon a liquidation, bankruptcy, reorganization, merger, acquisition, sale, dissolution or winding up of the Company, whether voluntarily or involuntarily. The holder of the Series A Preferred Stock was not entitled to receive dividends of any kind. The Series A Preferred Stock was redeemed in whole on July 5, 2022 upon the effectiveness of the amendment to the Restated Certificate of Incorporation implementing the reverse stock split. As of December 31, 2023, there were no shares of preferred stock outstanding. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION Equity Incentive Plans On December 27, 2023, the Company’s Board terminated the Fresh Tracks Therapeutics, Inc. 2020 Omnibus Long-Term Incentive Plan (the “2020 Plan”), the Amended and Restated 2009 Equity Incentive Plan of Brickell Biotech, Inc. (the “2009 Plan”), and the Amended and Restated Stock Incentive Plan of Vical Incorporated (the “Vical Plan”), and all outstanding options and unvested restricted stock units (“RSUs”) granted thereunder, effective December 28, 2023. On April 20, 2020, the Company’s stockholders approved the 2020 Plan, which replaced, with respect to new award grants, the 2009 Plan and the Vical Plan (collectively, the “Prior Plans”) that were previously in effect. Following the approval of the 2020 Plan on April 20, 2020, no further awards were available to be issued under the Prior Plans but awards outstanding under those plans as of that date remained outstanding in accordance with their terms. Because the exercise price of each of the outstanding stock options as of December 28, 2023 was above the closing price of the Company’s common stock on December 28, 2023, the Board cancelled and terminated the outstanding options as of December 28, 2023 without any consideration. With respect to the outstanding RSUs on December 28, 2023, the Board decided to replace the value of the terminated RSUs with a right to a cash payment, subject to the same vesting schedule and payment date as the RSUs, with such cash payments valued by multiplying the number of RSUs held by each grantee by the closing price of the Company’s common stock on December 28, 2023. Fair Value Assumptions The Company accounts for share-based compensation expense for stock options granted to employees, members of its Board, and non-employees by estimating the fair value of each stock-based award on the date of grant using the Black-Scholes option pricing model. The Company recognizes share-based compensation expense on a straight-line basis over the vesting term. The Company applies an estimated forfeiture rate based on past history and makes revisions, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company considers the fair value of common stock to be equal to its current share price. If applicable, the current share price is adjusted to reflect material nonpublic information known to the Company but unavailable to market participants. The determination of the fair value of stock-based awards on the date of grant using an option-pricing model is affected by the value of the Company’s stock price, as well as assumptions regarding subjective variables. These variables include expected stock price volatility over the term of the awards, actual and projected employee stock option exercise behaviors, risk-free interest rate, and expected dividends. Because the Company has a limited history of stock purchase and sale activity, the Company estimates expected volatility of the common stock by using the average share fluctuations of companies similar in size, operations, and life cycle. The expected term of stock options granted to employees, including members of the Board, is determined as the midpoint between the vesting date and the contractual end of the option grant. The expected term of all other stock options granted is based on the Company’s historical share option exercise experience, which approximates the midpoint between the vesting date and the contractual end of the option grant. The risk-free interest rates used in the valuation model are based on U.S. Treasury yield issues in effect at the time of grant for a period commensurate with the expected term of the grant. The Company does not anticipate paying any dividends in the foreseeable future and therefore uses an expected dividend yield of zero. Stock Options Stock options granted by the Company have an exercise price per share equal to the closing sales price of the common stock on the day prior to the date of grant and expire ten years from the date of grant. The vesting term of granted stock options is stated in each individual grant agreement, which is generally four years. During the year ended December 31, 2023, the Company did not grant any stock options. During the year ended December 31, 2022, the Company granted stock options with a weighted-average grant date fair value of $7.95 per share. The assumptions used to calculate the fair value of stock options granted are as follows, presented on a weighted-average basis: Year Ended 2023 2022 Expected term N/A 6.0 years Expected volatility N/A 97.8% Risk-free interest rate N/A 3.1% Expected dividend yield N/A —% A summary of stock option activity under the Company’s incentive plans is as follows: Shares Weighted- Total Weighted-Average Remaining Contractual Life Outstanding as of December 31, 2022 215,316 $ 84.10 $ — 8.21 Forfeited (67,876) $ 61.88 Expired (3,452) $ 573.92 Cancelled (143,988) $ 82.83 Outstanding as of December 31, 2023 — $ — $ — — As of December 31, 2023, the Company had no unrecognized share-based compensation expense related to stock options. The total estimated grant date fair value of stock options vested during the years ended December 31, 2023 and 2022 was $1.6 million and $2.3 million, respectively. Restricted Stock Units RSU activity during the year ended December 31, 2023 is shown below: Shares Weighted Average Grant Date Fair Value Unvested as of December 31, 2022 — $ — Granted 141,250 $ 2.40 Vested (1) (110,000) $ 2.40 Forfeited (8,750) $ 2.40 Repurchased (2) (22,500) $ 2.40 Unvested as of December 31, 2023 — $ — ____________ (1) The Company issued 66,831 shares of common stock in settlement of 110,000 vested RSUs, net of shares withheld for taxes. (2) On December 28, 2023, there were 22,500 outstanding RSUs that were terminated and replaced with a right to a cash payment, subject to the same vesting schedule as the RSUs. In December 2023, a liability was established for the aggregate cash payment, and in January 2024, the Company paid an aggregate amount of $20 thousand to the RSU holders. The Company has no pattern of cash settling equity awards. The total grant date fair value and the total vest date fair value of RSUs vested during the year ended December 31, 2023 were both approximately $0.3 million. As of December 31, 2023, the Company had no unrecognized share-based compensation expense related to RSU awards. Employee Stock Purchase Plan On April 19, 2021, the Company’s stockholders approved the Fresh Tracks Therapeutics, Inc. Employee Stock Purchase Plan (the “ESPP”), which had a first eligible purchase period commencing on July 1, 2021. The ESPP allowed qualified employees to purchase shares of the Company’s common stock at a price per share equal to 85% of the lower of: (i) the closing price of the Company’s common stock on the first trading day of the applicable purchase period or (ii) the closing price of the Company’s common stock on the last trading day of the applicable purchase period. New six-month purchase periods began each January 1 and July 1. On December 14, 2023, the Company’s Board terminated the ESPP. The final purchase period under the ESPP began on January 1, 2023 and ended on June 30, 2023. Stock-Based Compensation Expense Total stock-based compensation expense reported in the consolidated statements of operations was allocated as follows (in thousands): Year Ended 2023 2022 Research and development $ 468 $ 425 General and administrative 1,451 1,731 Total stock-based compensation expense $ 1,919 $ 2,156 Because all outstanding stock options were cancelled as of December 28, 2023, the Company recognized remaining compensation of $0.2 million during the year ended December 31, 2023 that would have been recognized in future periods had the stock options not been cancelled. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES During the years ended December 31, 2023 and 2022, the Company recorded no income tax benefits for the NOL incurred in each year, due to its uncertainty of realizing a benefit from those items. A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended 2023 2022 Federal statutory income tax rate 21.00 % 21.00 % State taxes, net of federal benefit 1.55 2.88 Research and development tax credits — 1.46 Permanent differences and other (25.83) (0.92) Stock-based compensation (3.28) (0.46) Change in deferred tax asset valuation allowance 6.56 (23.96) Effective income tax rate — % — % Approximate deferred tax assets (liabilities) resulting from timing differences between financial and tax bases were associated with the following items (in thousands): Year Ended 2023 2022 NOL carryforwards $ 106,071 $ 104,278 Research and development and other tax credits 17,340 17,247 Depreciable assets 3,387 4,812 Capitalized research and development costs 3,223 2,347 Intangible assets 1,664 1,797 Stock-based compensation — 1,505 Other 9 82 Net deferred tax asset 131,694 132,068 Less: valuation allowance (131,694) (132,068) Net deferred tax assets $ — $ — As of December 31, 2023, the Company had deferred tax assets of $131.7 million. Due to uncertainties surrounding the Company’s ability to generate future taxable income to realize these assets, a full valuation allowance has been established to offset the net deferred tax asset. Pursuant to Sections 382 and 383 of the Internal Revenue Code (“IRC”), annual use of the Company’s NOL and credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. The most recent Section 382 analysis was completed through December 31, 2011 as a result of a previous ownership change on December 29, 2006, as determined per the provisions of Section 382 of the IRC as a result of various stock issuances used to finance the Company’s operations. Such ownership change resulted in annual limitations on the utilization of tax attributes, including NOL carryforwards and tax credits. A Section 382 analysis has not been conducted for the period between January 1, 2012 through December 31, 2023. As such, the Company cannot provide any assurance that a change in ownership within the meaning of the IRC has not occurred between those dates. If a change in ownership were to have occurred, additional NOL and tax credit carryforwards could be eliminated or restricted. If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. As of December 31, 2023 and 2022, the Company had available federal NOL carryforwards of approximately $432.7 million and $454.5 million, respectively. The NOLs generated after 2017, totaling $156.0 million, will carry forward indefinitely and be available to offset up to 80% of future taxable income each year. NOLs generated before 2018, totaling $276.7 million, will expire from 2024 through 2037. In addition, the Company had federal research and development credits and orphan drug credit carryforwards of $23.5 million and $24.8 million as of December 31, 2023 and 2022, respectively, to reduce future federal income taxes, if any, which expire from 2024 through 2038. The Company also has available state NOL carryforwards of approximately $452.3 million and $444.4 million as of December 31, 2023 and 2022, respectively, which expire from 2028 to 2038. All federal and state NOL and credit carryforwards listed above are reflected before the reduction for amounts effectively eliminated under Sections 382 and 383. Based upon statute, federal and state NOLs and credits are expected to expire as follows (in thousands): Expiration Date: Federal NOLs State NOLs Federal R&D Credit Federal Orphan Drug Credit State R&D Credit 2024 25,032 — 213 663 — 2025 27,190 — 455 507 — 2026 21,858 — 451 302 — 2027 and thereafter 202,583 390,917 7,923 13,003 — Indefinite 156,032 61,353 — — 9,763 Totals $ 432,695 $ 452,270 $ 9,042 $ 14,475 $ 9,763 The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its lack of commercialization of any products and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31, 2023 and 2022. Management reevaluates the positive and negative evidence at each reporting period. The Company’s valuation allowance decreased by approximately $0.4 million for the year ended December 31, 2023. For the year ended December 31, 2022, the valuation allowance increased by $5.1 million. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While the Company believes that it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcome of examinations by tax authorities in determining the adequacy of its provision for income taxes. The Company had previously acquired gross unrecognized tax benefits with a balance of $21.7 million as of December 31, 2023 and 2022, none of which would affect the effective tax rate, due to the Company’s full valuation allowance on its deferred tax assets. The Company does not anticipate any significant decreases in its unrecognized tax benefits over the next 12 months. As of December 31, 2023, the Company’s U.S. federal and state tax returns remain subject to examination by tax authorities beginning with the tax year ended December 31, 2020. However, due to NOLs and credit carryforwards being generated and carried forward from prior tax years, substantially all tax years may also be subject to examination. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net loss | $ (5,694) | $ (21,102) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
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 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation |
Use of Estimates | Use of Estimates The Company’s consolidated financial statements are prepared in accordance with U.S. GAAP, which requires it 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 financial statements and the reported amounts of revenue and expenses during the reporting period. Although these estimates are based on the Company’s knowledge of current events and actions it may take in the future, actual results may ultimately differ from these estimates and assumptions. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less from date of purchase to be cash equivalents. Cash equivalents consist primarily of amounts held in short-term money market accounts with highly rated financial institutions. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains cash and cash equivalents balances in several accounts with one financial institution which, from time to time, are in excess of federally insured limits. One third party individually accounted for all of the Company’s revenue for the years ended December 31, 2023 and 2022, as well as associated accounts receivable and contract asset balances as of December 31, 2022. Refer to Note 3. “Strategic Agreements ” for a detailed discussion of agreements with Botanix SB Inc. and Botanix Pharmaceuticals Limited (“Botanix”) and the termination of the Company’s future payment rights in exchange for a single up-front payment in the year ended December 31, 2023. |
Property and Equipment | Property and Equipment three |
Fair Value Measurements and Fair Value of Financial Instruments | Fair Value Measurements Fair value is the price that the Company would receive to sell an asset or pay to transfer a liability in a timely transaction with an independent counterparty in the principal market, or in the absence of a principal market, the most advantageous market for the asset or liability. A three-tier hierarchy distinguishes between (1) inputs that reflect the assumptions market participants would use in pricing an asset or liability developed based on market data obtained from sources independent of the reporting entity (observable inputs) and (2) inputs that reflect the reporting entity’s own assumptions about the assumptions market participants would use in pricing an asset or liability developed based on the best information available in the circumstances (unobservable inputs). The hierarchy is summarized in the three broad levels listed below: Level 1 —quoted prices in active markets for identical assets and liabilities Level 2 —other significant observable inputs (including quoted prices for similar assets and liabilities, interest rates, credit risk, etc.) Level 3 —significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities) Fair Value of Financial Instruments The following methods and assumptions were used by the Company in estimating the fair values of each class of financial instrument disclosed herein: Money Market Funds— The carrying amounts reported as cash equivalents in the consolidated balance sheets approximate their fair values due to their short-term nature and market rates of interest. The carrying values of cash equivalents, accounts receivable, accounts payable, and accrued liabilities approximate fair value due to the short-term maturity of those items. |
Revenue Recognition | Revenue Recognition The Company has historically recognized revenue primarily from upfront fees, research and development milestones, research reimbursements, and consulting services fees related to the development of previously owned or sublicensed assets associated with the proprietary compound sofpironium bromide, as well as sublicense income and royalty fees on sales of sofpironium bromide gel, 5% (ECCLOCK ® ) in Japan. The Company recognizes revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. In determining the appropriate amount of revenue to be recognized, 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, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company utilizes judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Contract Revenue The Company evaluates its contracts, including asset sale arrangements that involve the Company’s rights to intellectual property, to determine whether they are outputs of the Company’s ordinary activities and whether the counterparty meets the definition of a customer. If the arrangement is determined to be a contract with a customer and the goods or services sold are determined to be distinct from other performance obligations identified in the arrangement, the Company recognizes revenue primarily from non-refundable upfront fees, milestone payments, sales-based payments, and fees for consulting services allocated to the goods or services when (or as) control is transferred to the customer, and the customer can use and benefit from the goods or services. Licenses of Intellectual Property If a license for the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue when the functional license is transferred to the customer, and the customer can use and benefit from the license. Milestones At the inception of each arrangement that includes milestone payments (variable consideration), excluding sales-based milestone payments discussed below, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. The most likely amount method is generally utilized when there are only two possible outcomes and represents the Company’s best estimate of the single most likely outcome to be achieved. If it is probable that a significant revenue reversal would not occur, the variable consideration for the associated milestone is included in the transaction price. Milestone payments contingent on regulatory approvals that are not within the Company or the Company’s collaboration partner’s control, as applicable, are generally not considered probable of being achieved until those approvals are received. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the variable consideration. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue in the period of adjustment. Sales-Based Payments For license arrangements that include sales-based payments such as royalties or milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the sales-based payments relate, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the sales-based payment has been allocated has been satisfied (or partially satisfied). Sales-based payments received under license arrangements are recorded as royalty revenue in the Company’s consolidated statements of operations. For non-license arrangements that include sales-based payments, including earnout payments and milestone payments based on the level of sales, the Company estimates the sales-based payments (variable consideration) to be achieved and recognizes revenue to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The Company may use either the most likely amount, as described above, or the expected value method, in making such estimates based on the nature of the payment to be received and whether there is a wide range of outcomes or only two possible outcomes. The expected value method represents the sum of probability-weighted amounts in a range of possible consideration amounts. The Company bases its estimates using the applicable method described above on factors such as, but not limited to, required regulatory approvals, historical sales levels, market events and projections, and other factors as appropriate. The Company updates its estimates at each reporting period based on actual results and future expectations as necessary. Contract Asset |
Research and Development | Research and Development Research and development costs are charged to expense when incurred and consist of costs incurred for independent and collaboration research and development activities. The major components of research and development costs include formulation development, nonclinical studies, clinical studies, clinical manufacturing costs, in-licensing fees for development-stage assets, salaries and employee benefits, and allocations of various overhead and occupancy costs. Research costs typically consist of applied research, preclinical, and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis, and the transfer and scale-up of manufacturing at contract manufacturers. Assets acquired (or in-licensed) that are utilized in research and development that have no alternative future use are expensed as incurred. Milestone payments related to the Company’s acquired (or in-licensed) assets are recorded as research and development expenses when probable and reasonably estimable. Costs for certain research and development activities, such as clinical trial expenses, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, and information provided to the Company by its vendor on their actual costs incurred or level of effort expended. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as prepaid expenses and other current assets or accrued expenses. When the Company enters into licensing or subscription arrangements to access and utilize certain technology, the Company evaluates if the license agreement results in the acquisition of an asset or a business. To date, none of the Company’s license agreements have been considered an acquisition of a business. For asset acquisitions, the upfront payments to acquire such licenses, as well as any future milestone payments made before product approval that do not meet the definition of a derivative, are immediately recognized as research and development expenses when they are paid or become payable, provided there is no alternative future use of the rights in other research and development projects. |
Net Loss per Share | Net Loss per Share Basic and diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing the Company’s net income by the weighted-average number of common shares outstanding and the impact of all potentially dilutive common shares. Diluted net loss per share is the same as basic net loss per share, as the effects of potentially dilutive securities are anti-dilutive for all periods presented. The following table sets forth the potential common shares excluded from the calculation of diluted net loss per share because their inclusion would be anti-dilutive: |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases with a term greater than one year are recognized on the consolidated balance sheets as right-of-use assets and lease liabilities. The Company does not hold any finance leases. The Company has elected the practical expedient not to recognize on the consolidated balance sheets leases with terms of one year or less and not to separate lease components and non-lease components for real estate leases. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company estimates the incremental borrowing rate in determining the present value of lease payments. Lease expense is recognized on a straight-line basis over the lease term. |
Redeemable Preferred Stock | Redeemable Preferred Stock The Company issued one share of redeemable preferred stock in May 2022. The redeemable preferred stock contained provisions that required redemption under circumstances that were outside of the Company’s control and was classified as a mezzanine instrument outside of the Company’s capital accounts. The share of redeemable preferred stock was sold to one investor for $10 and was subsequently redeemed in July 2022, as described further in Note 6. “ Capital Stock. ” |
Income Taxes | Income Taxes The Company accounts for income taxes by using an asset and liability method of accounting for deferred income taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financ ial statement carrying amounts of existing assets and liabilities and their respective tax bases. A valuation allowance is recorded to the extent it is more likely than not that a deferred tax asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. The Company’s significant deferred tax assets are for net operati ng loss (“NOL”) carryforwards, ta x credits, fixed assets, and intangible assets. The Company has provided a valuation allowance for its entire net deferred tax assets since inception because, due to its history of operating losses, the Company has concluded that it is more likely than not that its deferred tax assets will not be realized. The Company recognizes interest and penalties arising from the underpayment of income taxes in the consolidated statements of operations as a component of income tax expense. The Company had no accrual for interest or penalties on its consolidated balance sheets as of December 31, 2023 and 2022, and has not recognized interest or penalties in its consolidated statements of operations for the years ended December 31, 2023 and 2022. |
New Accounting Pronouncements | New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards has had or will have a material impact on the Company’s consolidated financial statements or disclosures. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Fair Value Measurements, Recurring and Nonrecurring | The following table sets forth the fair value of the Company’s financial assets measured at fair value on a recurring basis based on the three-tier fair value hierarchy (in thousands): Level 1 December 31, 2023 2022 Money market funds $ 10,617 $ 7,680 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Year Ended 2023 2022 Outstanding common stock warrants 621,063 621,063 Outstanding options — 215,316 Total 621,063 836,379 |
STRATEGIC AGREEMENTS (Tables)
STRATEGIC AGREEMENTS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Revenue from External Customers by Products and Services | The Company recognized the following as contract revenue (in thousands): Year Ended 2023 2022 Buyout of Post-Closing Payment Obligations $ 7,944 $ — Sublicense Income 53 433 Consulting services provided under the TSA 9 794 Upfront consideration — 3,000 Milestone payment received upon acceptance by FDA of NDA filing — 2,000 Reimbursed development expenditures under the Asset Purchase Agreement — 624 Total contract revenue $ 8,006 $ 6,851 |
Schedule of Contract with Customer, Contract Asset, Contract Liability, and Receivable | The following table presents changes in the value of the Company’s contract asset related to Sublicense Income for the following periods (in thousands): Contract asset as of January 1, 2023 $ 318 Amounts received (318) Contract asset as of December 31, 2023 $ — Contract asset as of January 1, 2022 $ — Sublicense Income recognized 433 Amounts received or receivable (115) Contract asset as of December 31, 2022 $ 318 Contract asset, included in prepaid expenses and other current assets $ 254 Contract asset, net of current portion $ 64 |
DETAILED ACCOUNT BALANCES (Tabl
DETAILED ACCOUNT BALANCES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Prepaid Expenses | Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2023 2022 Prepaid insurance $ 545 $ 521 Accounts receivable 45 250 Contract asset — 254 Prepaid research and development expenses — 254 Other 94 124 Total $ 684 $ 1,403 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2023 2022 Accrued severance $ 1,018 $ — Accrued compensation 232 1,320 Accrued professional fees — 705 Accrued research and development expenses — 432 Total $ 1,250 $ 2,457 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Lease, Cost | The following table presents information pertaining to the Company’s former operating leases (in thousands): Year Ended 2023 2022 Operating lease cost $ 67 $ 62 Variable lease cost $ 20 $ 39 Cash outflows from operating leases $ 81 $ 111 Weighted-average remaining lease term — years 0.5 years Weighted-average discount rate 11.0 % 11.0 % |
CAPITAL STOCK (Tables)
CAPITAL STOCK (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Reserved Authorized Shares of Common Stock | The Company had reserved authorized shares of common stock for future issuance as of December 31, 2023 as follows: December 31, Common stock warrants 621,063 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Valuation Assumptions | The assumptions used to calculate the fair value of stock options granted are as follows, presented on a weighted-average basis: Year Ended 2023 2022 Expected term N/A 6.0 years Expected volatility N/A 97.8% Risk-free interest rate N/A 3.1% Expected dividend yield N/A —% |
Schedule of Stock Option Activity | A summary of stock option activity under the Company’s incentive plans is as follows: Shares Weighted- Total Weighted-Average Remaining Contractual Life Outstanding as of December 31, 2022 215,316 $ 84.10 $ — 8.21 Forfeited (67,876) $ 61.88 Expired (3,452) $ 573.92 Cancelled (143,988) $ 82.83 Outstanding as of December 31, 2023 — $ — $ — — |
Schedule of Restricted Stock Unit Activity | RSU activity during the year ended December 31, 2023 is shown below: Shares Weighted Average Grant Date Fair Value Unvested as of December 31, 2022 — $ — Granted 141,250 $ 2.40 Vested (1) (110,000) $ 2.40 Forfeited (8,750) $ 2.40 Repurchased (2) (22,500) $ 2.40 Unvested as of December 31, 2023 — $ — ____________ (1) The Company issued 66,831 shares of common stock in settlement of 110,000 vested RSUs, net of shares withheld for taxes. (2) On December 28, 2023, there were 22,500 outstanding RSUs that were terminated and replaced with a right to a cash payment, subject to the same vesting schedule as the RSUs. In December 2023, a liability was established for the aggregate cash payment, and in January 2024, the Company paid an aggregate amount of $20 thousand to the RSU holders. The Company has no pattern of cash settling equity awards. |
Schedule of Share-Based Compensation Expense | Total stock-based compensation expense reported in the consolidated statements of operations was allocated as follows (in thousands): Year Ended 2023 2022 Research and development $ 468 $ 425 General and administrative 1,451 1,731 Total stock-based compensation expense $ 1,919 $ 2,156 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended 2023 2022 Federal statutory income tax rate 21.00 % 21.00 % State taxes, net of federal benefit 1.55 2.88 Research and development tax credits — 1.46 Permanent differences and other (25.83) (0.92) Stock-based compensation (3.28) (0.46) Change in deferred tax asset valuation allowance 6.56 (23.96) Effective income tax rate — % — % |
Schedule of Deferred Tax Assets and Liabilities | Approximate deferred tax assets (liabilities) resulting from timing differences between financial and tax bases were associated with the following items (in thousands): Year Ended 2023 2022 NOL carryforwards $ 106,071 $ 104,278 Research and development and other tax credits 17,340 17,247 Depreciable assets 3,387 4,812 Capitalized research and development costs 3,223 2,347 Intangible assets 1,664 1,797 Stock-based compensation — 1,505 Other 9 82 Net deferred tax asset 131,694 132,068 Less: valuation allowance (131,694) (132,068) Net deferred tax assets $ — $ — |
Summary of Federal and State Carryforwards and Credits Maturity | All federal and state NOL and credit carryforwards listed above are reflected before the reduction for amounts effectively eliminated under Sections 382 and 383. Based upon statute, federal and state NOLs and credits are expected to expire as follows (in thousands): Expiration Date: Federal NOLs State NOLs Federal R&D Credit Federal Orphan Drug Credit State R&D Credit 2024 25,032 — 213 663 — 2025 27,190 — 455 507 — 2026 21,858 — 451 302 — 2027 and thereafter 202,583 390,917 7,923 13,003 — Indefinite 156,032 61,353 — — 9,763 Totals $ 432,695 $ 452,270 $ 9,042 $ 14,475 $ 9,763 |
ORGANIZATION AND NATURE OF OP_2
ORGANIZATION AND NATURE OF OPERATIONS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Net loss | $ (5,694) | $ (21,102) |
Net cash used in operating activities | (4,343) | (19,335) |
Cash and cash equivalents | 10,868 | 8,680 |
Accumulated deficit | $ (172,163) | $ (166,469) |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) | 1 Months Ended | 12 Months Ended | ||
Jul. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | May 25, 2022 shares | |
Class of Stock [Line Items] | ||||
Number of operating segments | segment | 1 | |||
Depreciation | $ 41,000 | $ 30,000 | ||
Preferred stock, shares outstanding (in shares) | shares | 1 | |||
Proceeds from issuance of redeemable preferred stock | $ 10 | |||
Minimum | ||||
Class of Stock [Line Items] | ||||
Useful life | 3 years | |||
Maximum | ||||
Class of Stock [Line Items] | ||||
Useful life | 5 years |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value of Assets and Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Recurring | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | $ 10,617 | $ 7,680 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Common Shares Excluded from EPS Calculations (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 621,063 | 836,379 |
Outstanding common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 621,063 | 621,063 |
Outstanding options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares excluded from the calculation of EPS (in shares) | 0 | 215,316 |
STRATEGIC AGREEMENTS - Addition
STRATEGIC AGREEMENTS - Additional Information (Details) $ in Thousands | 12 Months Ended | ||||||
Jul. 21, 2023 USD ($) | Nov. 10, 2022 USD ($) | May 03, 2022 USD ($) | Aug. 27, 2021 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Feb. 02, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Research and development expense, future payment, payment two | $ 107,500 | ||||||
Royalty payments, maximum percentage of net sales | 10% | ||||||
Milestone payment | $ 1,000 | ||||||
Total revenue | $ 8,006 | $ 6,943 | |||||
Value of shares issued in agreement | $ 1,000 | ||||||
General and administrative | 11,184 | 14,434 | |||||
Botanix | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Contract with customer, asset, purchase | $ 6,600 | ||||||
Royalty revenue | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Total revenue | 0 | 92 | |||||
Voronoi Inc. | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Research and development expense, future payment, payment one | $ 211,000 | ||||||
Carna Biosciences, Inc. | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Collaborative arrangement, rights and obligations, one-time cash payment | $ 2,000 | ||||||
Collaborative arrangement, rights and obligations, maximum aggregate milestone payments | $ 258,000 | ||||||
Collaborative arrangement, rights and obligations, royalty payments, percent of net sales | 0.10 | ||||||
Kaken | Milestone Payments | Maximum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue, remaining performance obligation, variable consideration amount | $ 10,000 | ||||||
Kaken | Royalty revenue | Maximum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue, remaining performance obligation, variable consideration amount | 19,000 | ||||||
Botanix | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Total revenue | 8,006 | 6,851 | |||||
Contract with customer, liability | $ 3,000 | ||||||
Collaborative agreement, administration fee percentage | 5% | ||||||
Botanix | Payment Criteria Three | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue, remaining performance obligation, variable consideration amount | $ 168,000 | ||||||
Botanix | Milestone Payments | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue, remaining performance obligation, variable consideration amount | 2,000 | ||||||
Botanix | Milestone Payments | Payment Criteria Two | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue, remaining performance obligation, variable consideration amount | 2,500 | ||||||
Botanix | Milestone Payments | Maximum | Payment Criteria One | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue, remaining performance obligation, variable consideration amount | 4,000 | ||||||
Botanix | Royalty revenue | Collaborative Arrangement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Total revenue | 100 | ||||||
Botanix | Consulting services provided under the TSA | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Total revenue | 9 | 794 | |||||
Collaborative agreement, monthly payment to be received | $ 71 | ||||||
Bodor Laboratories, Inc. | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Collaborative agreement, percentage of actual fees to be paid | 20% | ||||||
Payment for asset purchase agreement | $ 1,000 | ||||||
General and administrative | $ 1,700 | $ 1,900 | |||||
Bodor Laboratories, Inc. | Botanix | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Contract with customer, asset, purchase | $ 1,700 |
STRATEGIC AGREEMENTS - Schedule
STRATEGIC AGREEMENTS - Schedule of Revenue from External Customers by Products and Services (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 8,006 | $ 6,943 |
Botanix | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 8,006 | 6,851 |
Buyout of Post-Closing Payment Obligations | Botanix | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 7,944 | 0 |
Sublicense Income | Botanix | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 53 | 433 |
Consulting services provided under the TSA | Botanix | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 9 | 794 |
Upfront consideration | Botanix | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 0 | 3,000 |
Milestone payment received upon acceptance by FDA of NDA filing | Botanix | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 0 | 2,000 |
Reimbursed development expenditures under the Asset Purchase Agreement | Botanix | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 0 | $ 624 |
STRATEGIC AGREEMENTS - Schedu_2
STRATEGIC AGREEMENTS - Schedule of Contract with Customer, Contract Asset, Contract Liability, and Receivable (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Contract With Customer, Asset, After Allowance For Credit Loss [Roll Forward] | ||
Contract asset, included in prepaid expenses and other current assets | $ 0 | $ 254 |
Contract asset, net of current portion | 0 | 64 |
Botanix | ||
Contract With Customer, Asset, After Allowance For Credit Loss [Roll Forward] | ||
Contract asset, beginning balance | 318 | 0 |
Sublicense Income recognized | 433 | |
Amounts received | (318) | (115) |
Contract asset, ending balance | $ 0 | 318 |
Contract asset, included in prepaid expenses and other current assets | 254 | |
Contract asset, net of current portion | $ 64 |
DETAILED ACCOUNT BALANCES - Sum
DETAILED ACCOUNT BALANCES - Summary of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Prepaid insurance | $ 545 | $ 521 |
Accounts receivable | 45 | 250 |
Contract asset | 0 | 254 |
Prepaid research and development expenses | 0 | 254 |
Other | 94 | 124 |
Total | $ 684 | $ 1,403 |
DETAILED ACCOUNT BALANCES - S_2
DETAILED ACCOUNT BALANCES - Summary of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued severance | $ 1,018 | $ 0 |
Accrued compensation | 232 | 1,320 |
Accrued professional fees | 0 | 705 |
Accrued research and development expenses | 0 | 432 |
Total | $ 1,250 | $ 2,457 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | May 04, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Extended lease term | 6 months | |
Lease termination fee | $ 5 | |
Remaining lease term | 4 months |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Lease Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 67 | $ 62 |
Variable lease cost | 20 | 39 |
Cash outflows from operating leases | $ 81 | $ 111 |
Weighted-average remaining lease term | 0 years | 6 months |
Weighted-average discount rate | 11% | 11% |
CAPITAL STOCK - Narrative (Deta
CAPITAL STOCK - Narrative (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||||
May 25, 2022 vote shares | Oct. 31, 2020 $ / shares shares | Jun. 30, 2020 $ / shares shares | Dec. 31, 2023 USD ($) vote $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Mar. 31, 2021 USD ($) | Apr. 30, 2020 USD ($) | Feb. 29, 2020 USD ($) $ / shares shares | |
Class of Stock [Line Items] | ||||||||
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 | ||||||
Common stock, par value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 | ||||||
Number of votes per share | vote | 1 | |||||||
Sale of stock, expiration term | 5 years | |||||||
Common stock, shares issued (in shares) | 5,973,306 | 3,018,940 | ||||||
Sale of stock, percentage of commission | 0.03 | |||||||
Temporary equity, shares authorized (in shares) | 5,000,000 | |||||||
Temporary equity, par or stated value per share (in dollars per share) | $ / shares | $ 0.01 | |||||||
Preferred stock, shares outstanding (in shares) | 1 | |||||||
Preferred stock, outstanding, votes | vote | 80,000,000 | |||||||
October 2020 Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares authorized to be repurchased (in shares) | 462,979 | |||||||
Common Stock Public Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Exercise price (in usd per share) | $ / shares | $ 56.25 | |||||||
Sale of stock, expiration term | 5 years | |||||||
Common stock, shares issued (in shares) | 328,669 | |||||||
2021 At Market Issuance Sales Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares issued in transaction (in shares) | 2,887,535 | 354,381 | ||||||
Aggregate offering price | $ | $ 50 | |||||||
Sale of stock, weighted average price per share (in usd per share) | $ / shares | $ 2.34 | $ 3.70 | ||||||
Consideration received on transaction | $ | $ 6.6 | $ 1.3 | ||||||
Shares remaining to be sold, amount | $ | $ 38 | |||||||
2020 At Market Issuance Sales Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares issued in transaction (in shares) | 0 | 0 | ||||||
Aggregate offering price | $ | $ 8 | |||||||
2020 At Market Issuance Sales Agreement Scenario 2 | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of stock additional shares authorized amount | $ | $ 2.6 | |||||||
Private Placement Offerings | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock, shares issued (in shares) | 21,111 | |||||||
Purchase Agreement | Lincoln Park | ||||||||
Class of Stock [Line Items] | ||||||||
Purchase obligation | $ | $ 28 | |||||||
Common Stock | October 2020 Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares issued in transaction (in shares) | 422,300 | |||||||
Common Stock Warrants | ||||||||
Class of Stock [Line Items] | ||||||||
Class of warrant or right, number of securities called by each warrant or right (in shares) | 1 | |||||||
Exercise price (in usd per share) | $ / shares | $ 32.40 | |||||||
Common Stock Warrants | October 2020 Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares authorized to be repurchased (in shares) | 40,663 | |||||||
Class of warrant or right, number of securities called by each warrant or right (in shares) | 1 | |||||||
Pre-Funded Warrant | Common Stock Public Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Class of warrant or right, number of securities called by each warrant or right (in shares) | 1 | |||||||
Stock issuable upon warrants (in shares) | 60,220 | |||||||
Accompanying Common Warrant | Common Stock Public Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Stock issuable upon warrants (in shares) | 388,920 | |||||||
Series A | Private Placement Offerings | ||||||||
Class of Stock [Line Items] | ||||||||
Exercise price (in usd per share) | $ / shares | $ 0.45 | |||||||
Stock issuable upon warrants (in shares) | 13,476 | |||||||
Series B | Private Placement Offerings | ||||||||
Class of Stock [Line Items] | ||||||||
Exercise price (in usd per share) | $ / shares | $ 52.20 | |||||||
Stock issuable upon warrants (in shares) | 34,588 | |||||||
Series A Redeemable Preferred Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Preferred stock, shares outstanding (in shares) | 0 |
CAPITAL STOCK - Reserved Author
CAPITAL STOCK - Reserved Authorized Shares of Common Stock (Details) | Dec. 31, 2023 shares |
Common stock warrants | |
Class of Stock [Line Items] | |
Shares of common stock reserved for future issuance (in share) | 621,063 |
STOCK-BASED COMPENSATION - Narr
STOCK-BASED COMPENSATION - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Estimated grant date fair value of stock options | $ 1,600,000 | $ 2,300,000 |
Stock purchase offering period | 6 months | |
Total stock-based compensation expense | $ 1,919,000 | $ 2,156,000 |
Stock-based compensation expense | $ 700,000 | |
Outstanding options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | |
Expiration term | 10 years | |
Award vesting period | 4 years | |
Weighted-average grant date fair value (in dollars per share) | $ 7.95 | |
Unrecognized share-based compensation expense | $ 0 | |
Employee Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 200,000 | |
Employee Stock | Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Discount from market price, purchase date | 85% | |
Unvested restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized share-based compensation expense | $ 0 | |
Estimated grant date fair value of stock options | $ 300,000 |
STOCK-BASED COMPENSATION - Fair
STOCK-BASED COMPENSATION - Fair Value Assumptions (Details) - Outstanding options | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | |
Weighted average | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years | |
Expected volatility | 97.80% | |
Risk-free interest rate | 3.10% | |
Expected dividend yield | 0% |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Shares | ||
Cancelled (in shares) | (143,988) | |
Weighted- Average Exercise Price | ||
Cancelled ,Weighted average exercise price (in usd per share) | $ 82.83 | |
Outstanding options | ||
Shares | ||
Options outstanding (in shares) | 215,316 | |
Forfeited (in shares) | (67,876) | |
Expired (in shares) | (3,452) | |
Options outstanding (in shares) | 0 | 215,316 |
Weighted- Average Exercise Price | ||
Weighted average exercise price (in usd per share) | $ 84.10 | |
Forfeited ,Weighted average exercise price (in usd per share) | 61.88 | |
Expired ,Weighted average exercise price (in usd per share) | 573.92 | |
Weighted average exercise price (in usd per share) | $ 0 | $ 84.10 |
Total Intrinsic Value | ||
Intrinsic Value, outstanding | $ 0 | $ 0 |
Weighted Average Remaining Contractual Life (In Years) | ||
Weighted average remaining contractual life (in years), outstanding | 0 years | 8 years 2 months 15 days |
STOCK-BASED COMPENSATION - Rest
STOCK-BASED COMPENSATION - Restricted Stock unit Activity (Details) - Unvested restricted stock units - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |
Dec. 28, 2023 | Jan. 31, 2024 | Dec. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Unvested at beginning of period (in shares) | 0 | 0 | |
Granted (in shares) | 141,250 | ||
Vested (in shares) | (110,000) | ||
Forfeited (in shares) | (22,500) | (8,750) | |
Repurchased (in shares) | (22,500) | ||
Unvested at End of period (in shares) | 0 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Unvested at beginning of period (in usd per share) | $ 0 | $ 0 | |
Granted (in usd per share) | 2.40 | ||
Vested (in usd per share) | 2.40 | ||
Forfeited (in usd per share) | 2.40 | ||
Repurchased (in usd per share) | 2.40 | ||
Unvested at end of period (in usd per share) | $ 0 | ||
Restricted stock, issued net of shares withheld for taxes (in shares) | 66,831 | ||
RSUs terminated (in shares) | 22,500 | 8,750 | |
Subsequent Event | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Aggregate cash payment | $ 20 |
STOCK-BASED COMPENSATION - Shar
STOCK-BASED COMPENSATION - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 1,919 | $ 2,156 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 468 | 425 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 1,451 | $ 1,731 |
INCOME TAXES - Effective Income
INCOME TAXES - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21% | 21% |
State taxes, net of federal benefit | 1.55% | 2.88% |
Research and development tax credits | 0% | 1.46% |
Permanent differences and other | (25.83%) | (0.92%) |
Stock-based compensation | (3.28%) | (0.46%) |
Change in deferred tax asset valuation allowance | 6.56% | (23.96%) |
Effective income tax rate | 0% | 0% |
INCOME TAXES - Summary of Defer
INCOME TAXES - Summary of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Abstract] | ||
NOL carryforwards | $ 106,071 | $ 104,278 |
Research and development and other tax credits | 17,340 | 17,247 |
Depreciable assets | 3,387 | 4,812 |
Capitalized research and development costs | 3,223 | 2,347 |
Intangible assets | 1,664 | 1,797 |
Stock-based compensation | 0 | 1,505 |
Other | 9 | 82 |
Net deferred tax asset | 131,694 | 132,068 |
Less: valuation allowance | (131,694) | (132,068) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES - Narrative (Detai
INCOME TAXES - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Net deferred tax asset | $ 131,694 | $ 132,068 |
Increase (decrease) in deferred tax asset valuation allowance | (400) | 5,100 |
Unrecognized tax benefits | 21,700 | 21,700 |
Research and experimental expenses | 5,000 | |
Federal Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 432,700 | 454,500 |
Research and experimental expenses, amortization period | 5 years | |
State and Local Jurisdiction | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 452,300 | 444,400 |
Foreign Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Research and experimental expenses, amortization period | 15 years | |
NOLs generated after 2017 | Federal Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 156,000 | |
NOLs generated before 2018 | Federal Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 276,700 | |
Federal research and development credits and orphan drug credit | Federal Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | $ 23,500 | $ 24,800 |
INCOME TAXES - Summary of Feder
INCOME TAXES - Summary of Federal and State Carryforwards and Credits Maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Federal R&D Credit | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | $ 9,042 | |
Federal R&D Credit | 2024 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 213 | |
Federal R&D Credit | 2025 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 455 | |
Federal R&D Credit | 2026 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 451 | |
Federal R&D Credit | 2027 and thereafter | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 7,923 | |
Federal R&D Credit | Indefinite | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 0 | |
Federal Orphan Drug Credit | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 14,475 | |
Federal Orphan Drug Credit | 2024 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 663 | |
Federal Orphan Drug Credit | 2025 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 507 | |
Federal Orphan Drug Credit | 2026 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 302 | |
Federal Orphan Drug Credit | 2027 and thereafter | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 13,003 | |
Federal Orphan Drug Credit | Indefinite | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 0 | |
State R&D Credit | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 9,763 | |
State R&D Credit | 2024 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 0 | |
State R&D Credit | 2025 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 0 | |
State R&D Credit | 2026 | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 0 | |
State R&D Credit | 2027 and thereafter | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 0 | |
State R&D Credit | Indefinite | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforwards | 9,763 | |
Federal NOLs | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 432,700 | $ 454,500 |
Federal NOLs | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 432,695 | |
Federal NOLs | 2024 | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 25,032 | |
Federal NOLs | 2025 | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 27,190 | |
Federal NOLs | 2026 | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 21,858 | |
Federal NOLs | 2027 and thereafter | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 202,583 | |
Federal NOLs | Indefinite | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 156,032 | |
State NOLs | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 452,300 | $ 444,400 |
State NOLs | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 452,270 | |
State NOLs | 2024 | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 0 | |
State NOLs | 2025 | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 0 | |
State NOLs | 2026 | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 0 | |
State NOLs | 2027 and thereafter | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 390,917 | |
State NOLs | Indefinite | Sections 382 and 383 | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 61,353 |