Cover
Cover | 12 Months Ended |
Dec. 31, 2022 | |
Cover [Abstract] | |
Document Type | S-4/A |
Entity Registrant Name | VALLON PHARMACEUTICALS, INC. |
Entity Incorporation, State or Country Code | DE |
Entity Primary SIC Number | 2834 |
Entity Tax Identification Number | 82-4369909 |
Entity Address, Address Line One | Two Logan Square100 N. 18th Street |
Entity Address, Address Line Two | Suite 300 |
Entity Address, City or Town | Philadelphia |
Entity Address, State or Province | PA |
Entity Address, Postal Zip Code | 19103 |
City Area Code | (267) |
Local Phone Number | 607-8255 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | false |
Entity Central Index Key | 0001824293 |
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Assets, Current [Abstract] | ||
Cash and cash equivalents | $ 3,781 | $ 3,702 |
Marketable securities, available-for-sale | 0 | 3,808 |
Prepaid expenses and other current assets | 371 | 619 |
Total current assets | 4,152 | 8,129 |
Other assets | 0 | 206 |
Total assets | 4,152 | 8,335 |
Liabilities, Current [Abstract] | ||
Accounts payable | 977 | 918 |
Accrued expenses | 711 | 1,430 |
Warrant liability | 122 | 0 |
Other current liabilities | 0 | 97 |
Total current liabilities | 1,810 | 2,445 |
Other liabilities | 0 | 72 |
Total liabilities | 1,810 | 2,517 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity (deficit): | ||
Common stock, $0.0001 par value; 250,000,000 shares authorized; 6,812,836 and 4,506,216 shares issued and outstanding as of December 31, 2021 and 2020, respectively | 1 | 0 |
Additional paid-in-capital | 31,267 | 27,722 |
Accumulated other comprehensive loss | 0 | (2) |
Accumulated deficit | (28,926) | (21,902) |
Total stockholders' equity (deficit) | 2,342 | 5,818 |
Total liabilities and stockholders' equity (deficit) | $ 4,152 | $ 8,335 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 |
Common Stock, shares authorized (in shares) | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 13,482,342 | 6,812,836 |
Common stock, shares outstanding (in shares) | 13,482,342 | 6,812,836 |
Statement of Operations and Com
Statement of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 1,170 | $ 5,187 |
General and administrative | 5,758 | 4,072 |
Total operating expenses | 6,928 | 9,259 |
Loss from operations | (6,928) | (9,259) |
Other income | 0 | 61 |
Revaluation of derivative liability | 0 | (89) |
Change in fair value of warrant liability | 384 | 0 |
Loss on warrant conversion | (506) | 0 |
Interest expense, net | 26 | (16) |
Net loss | (7,024) | (9,303) |
Other comprehensive loss: | ||
Unrealized loss on marketable securities, available-for-sale | 2 | (2) |
Total comprehensive loss | $ (7,022) | $ (9,305) |
Net loss per share of common stock, basic (in usd per share) | $ (0.69) | $ (1.42) |
Net loss per share of common stock, diluted (in usd per share) | $ (0.69) | $ (1.42) |
Weighted-average common shares outstanding, basic (in shares) | 10,143,205 | 6,541,097 |
Weighted-average common shares outstanding, diluted (in shares) | 10,143,205 | 6,541,097 |
Statements of Changes in Stockh
Statements of Changes in Stockholders’ Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning Balance, shares (in shares) at Dec. 31, 2020 | 4,506,216 | ||||
Beginning Balance at Dec. 31, 2020 | $ (1,454) | $ 0 | $ 11,145 | $ 0 | $ (12,599) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock for convertible notes (in shares) | 54,906 | ||||
Issuance of common stock for convertible notes | 439 | 439 | |||
Issuance of common stock for IPO, net of issuance expenses (in shares) | 2,250,000 | ||||
Issuance of common stock for IPO, net of issuance expenses | 15,104 | 15,104 | |||
Issuance of common stock for services (in shares) | 1,714 | ||||
Issuance of common stock for services | 9 | 9 | |||
Issuance of Underwriters Warrants | 399 | 399 | |||
Stock-based compensation expense | 626 | 626 | |||
Unrealized loss on marketable securities, available-for-sale | (2) | (2) | |||
Net loss | $ (9,303) | (9,303) | |||
Ending Balance, shares (in shares) at Dec. 31, 2021 | 6,812,836 | 6,812,836 | |||
Ending Balance at Dec. 31, 2021 | $ 5,818 | $ 0 | 27,722 | (2) | (21,902) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock for IPO, net of issuance expenses (in shares) | 3,700,000 | ||||
Issuance of common stock for IPO, net of issuance expenses | 2,161 | $ 1 | 2,160 | ||
Issuance of common stock upon warrant exercise (in shares) | 2,960,000 | ||||
Issuance of common stock upon warrant exercise | 1,286 | 1,286 | |||
Vesting of restricted stock (in shares) | 9,506 | ||||
Stock-based compensation expense | 99 | 99 | |||
Unrealized loss on marketable securities, available-for-sale | 2 | 2 | |||
Net loss | $ (7,024) | (7,024) | |||
Ending Balance, shares (in shares) at Dec. 31, 2022 | 13,482,342 | 13,482,342 | |||
Ending Balance at Dec. 31, 2022 | $ 2,342 | $ 1 | $ 31,267 | $ 0 | $ (28,926) |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Net Cash Provided by (Used in) Operating Activities [Abstract] | ||
Net loss | $ (7,024) | $ (9,303) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Amortization of finance lease right-of-use asset | 206 | 73 |
Amortization of marketable securities premiums | 28 | 32 |
Stock-based compensation expense | 99 | 626 |
Revaluation of derivative liability | 0 | 89 |
Change in fair value of warrant liability | (384) | 0 |
Loss on warrant conversion | 506 | 0 |
Forgiveness of PPP note | 0 | (61) |
Non-cash interest, depreciation and other expense | 0 | 12 |
Change in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 248 | (55) |
Accounts payable | (95) | (308) |
Accrued expenses | (719) | 583 |
Cash used in operating activities | (7,135) | (8,312) |
Investing activities: | ||
Purchase of marketable securities | (640) | (3,842) |
Sale of marketable securities | 4,422 | 0 |
Cash used in investing activities | 3,782 | (3,842) |
Financing activities: | ||
Proceeds from common stock issuance, net of offering expenses | 3,447 | 15,104 |
Proceeds from issuance of warrants | 0 | 399 |
Proceeds from convertible notes | 0 | 350 |
Payment of finance lease liability | (15) | (106) |
Cash provided by (used in) financing activities | 3,432 | 15,747 |
Net increase (decrease) in cash and cash equivalents | 79 | 3,593 |
Cash and cash equivalents at beginning of period | 3,702 | 109 |
Cash and cash equivalents at end of period | 3,781 | 3,702 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 21 | 29 |
Non-cash financing activities: | ||
Conversion of convertible notes to common stock | 0 | 350 |
Non-cash exercise of warrants | 782 | 0 |
Finance lease liability costs included in accounts payable | $ 154 | $ 0 |
ORGANIZATION AND DESCRIPTION OF
ORGANIZATION AND DESCRIPTION OF BUSINESS | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | ORGANIZATION AND DESCRIPTION OF BUSINESS Vallon Pharmaceuticals, Inc. (Vallon or the Company) was incorporated in Delaware in January 2018 (inception) and is based in Philadelphia, PA. The Company is a biopharmaceutical company which has historically focused on the development and commercialization of novel abuse-deterrent medications for central nervous system (CNS) disorders. The Company’s lead investigational product candidate, ADAIR, was a proprietary, abuse-deterrent oral formulation of immediate-release dextroamphetamine (the main active ingredient in Adderall®), which was being developed for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) and narcolepsy. In March 2022, the Company announced that its Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (SEAL) study for ADAIR did not reach its primary endpoint. In addition to ADAIR, the Company’s second product candidate, ADMIR, an abuse deterrent formulation of methylphenidate (Ritalin®), was also being developed for the treatment of ADHD. While assessing the best path forward for the ADAIR and ADMIR development programs in relation to the results of the SEAL study, the Company engaged Ladenburg Thalmann & Co. Inc. (Ladenburg) to evaluate its strategic alternatives with the goal of maximizing stockholder value. Ladenburg was engaged to advise on the strategic review process, which could have included, without limitation, exploring the potential for a possible merger, business combination, investment into the Company, or a purchase, license or other acquisition of assets. In conjunction with the exploration of strategic alternatives, the Company streamlined operations to preserve its capital and cash resources. After conducting a diligent and extensive process of evaluating strategic alternatives and identifying and reviewing potential candidates for a strategic acquisition or other transaction, which included the receipt of 15 formal merger proposals from interested parties and careful evaluation and consideration of those proposals, and following extensive negotiation with a number of possible candidates, on December 13, 2022, Vallon and GRI Bio, Inc. (GRI) entered into an Agreement and Plan of Merger (the Merger Agreement), pursuant to which a wholly-owned subsidiary of Vallon will merge with and into GRI, with GRI surviving as a wholly-owned subsidiary of Vallon (the Merger). The Merger will result in a clinical-stage biotechnology company focused on discovering, developing, and commercializing innovative therapies targeting serious diseases associated with dysregulated immune responses that lead to inflammatory, fibrotic, and autoimmune disorders. At the effective time of the Merger (the Effective Time), each share of common stock of GRI, $0.01 par value per share (GRI Common Stock) outstanding immediately prior to the Effective Time, excluding any dissenting shares but including any shares of GRI Common Stock issued pursuant to the concurrent equity financing will be automatically converted into the right to receive a number of shares of common stock of Vallon, $0.0001 par value per share (Vallon Common Stock) equal to the exchange ratio, subject to adjustment for the proposed reverse stock split of Vallon Common Stock to be implemented prior to the consummation of the Merger as discussed in this Annual Report (the Reverse Split). The exchange ratio may be adjusted based on Vallon’s net cash at Closing and/or any reduction to Vallon’s valuation required in order to meet the initial listing requirements of The Nasdaq Stock Market LLC (Nasdaq). |
LIQUIDITY
LIQUIDITY | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LIQUIDITY | LIQUIDITYThese financial statements have been prepared on the basis that the Company is a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company has not generated any significant revenues from operations since inception, and does not expect to do so in the foreseeable future. The Company has incurred operating losses since inception and has incurred $28,926 in accumulated deficit through December 31, 2022. The Company has financed its working capital requirements to date through the issuance of common stock, convertible notes, short-term promissory notes, and a Paycheck Protection Program (PPP) note. In January 2021, the Company completed a $350 convertible note financing and in February 2021 the Company closed on its initial public offering (IPO) raising net proceeds of approximately $15,500. On May 17, 2022, the Company entered into a Securities Purchase Agreement with certain investors (the Securities Purchase Agreement) for the sale of up to 3,700,000 shares of the Company’s common stock, par value $0.0001 per share (the Shares), at a purchase price of $1.0632 per Share in a registered direct offering (the Offering). In a concurrent private placement also pursuant to the Securities Purchase Agreement (the Private Placement), for each Share of common stock purchased by an investor, such investor was entitled receive from the Company an unregistered warrant (the Warrant and, together with the Shares, the Securities) to purchase one Share of common stock. The gross proceeds from the Offering and Private Placement were approximately $3,900, before deducting fees payable to the placement agent and other estimated offering expenses payable by the Company of approximately $572, of which $85 related to the warrants was expensed. As of December 31, 2022, the Company had cash and cash equivalents of approximately $3,781. Although the Company has entered into the Merger Agreement and intends to consummate the transaction, there is no assurance that the Company will be able to successfully consummate the proposed merger on a timely basis, or at all. If, for any reason, the Merger is not completed, the Company will reconsider its strategic alternatives and could pursue one or more of the following courses of action: • Dissolve and liquidate its assets. If, for any reason, the merger is not consummated and the Company is unable to identify and complete an alternative strategic transaction like a merger or potential collaborative, partnering or other strategic arrangements for its assets, or continue to operate its business due to the inability to raise additional funding, the Company may be required to dissolve and liquidate our assets. In such case, there can be no assurances as to the amount or timing of available cash left to distribute to its stockholders, if any, after paying its debts and other obligations and setting aside funds for reserves. • Pursue potential collaborative, partnering or other strategic arrangements for its assets, including a sale or other divestiture. • Continue to operate its business. Although presently not anticipated, the Company could elect to continue to operate its business and pursue licensing or partnering transactions. Based on its prior assessment, this would require a significant amount of time, financial resources, human capital and is would be subject to all the risk and uncertainties involved in the development of product candidates. In such instance, there is no assurance that the Company could raise sufficient capital to support these efforts, that its development efforts would be successful or that the Company could successfully obtain the regulatory approvals required to market any product candidate we pursued. • Pursue another strategic transaction like the proposed merger. The Company’s ability to continue as a going concern is dependent on raising capital from the sale of our common stock and/or obtaining debt financing. The Company’s future capital requirements are difficult to forecast and will depend on many factors, including but not limited to the closing of the Merger or the terms and timing of any other strategic alternatives including a merger or business combination, asset acquisitions or sales, collaborations or licensing arrangements. The Company’s ability to remain a going concern is wholly dependent upon its ability to continue to obtain sufficient capital to fund its operations. If the Company raises additional funds by issuing equity securities, its stockholders may experience dilution. Any future debt financing may impose upon it covenants that restrict our operations, including limitations on its ability to incur liens or additional debt, pay dividends, repurchase its common stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any equity or debt financing may contain terms that are not favorable to the Company or its stockholders. If the Company is unable to raise additional funds when needed, it may be required to delay, reduce or terminate some or all of its development programs and clinical trials. The Company may also be required to sell or license to other parties’ rights to develop or commercialize its drug candidates that it would prefer to retain. Therefore, there is substantial doubt about the Company’s ability to |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES References in this Annual Report on Form 10-K to “authoritative guidance” is meant to refer to accounting principles generally accepted in the United States of America (GAAP) as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB). Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Estimates and assumptions are primarily made in relation to the valuation of share options, the embedded derivative of convertible notes, warrant issuance and subsequent revaluations, valuation allowances relating to deferred tax assets, revenue recognition, accrued expenses and estimation of the incremental borrowing rate for the finance lease. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate. Concentration of credit risk The Company from time to time during the period covered by these financial statements may have had bank account balances in excess of federally insured limits. The Company has not experienced losses in such accounts. The Company believes that it is not subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Cash equivalents Cash equivalents are highly-liquid investments that are readily convertible into cash with original maturities of three months or less when purchased and as of December 31, 2022 and 2021 included investment in money market funds. Marketable securities Marketable securities consist of debt securities that are designated as available-for-sale. Amortization of premiums and discounts on marketable securities are included in interest expense, net on the statements of operations and comprehensive loss. Realized gains or losses resulting from the sale of these securities are determined based on the specific identification of the securities sold. An impairment charge is recognized when the decline in the fair value of a debt security below the amortized cost basis is determined to be other-than-temporary. The Company considers various factors in determining whether to recognize an impairment charge, including the duration and severity of any decline in fair value below the amortized cost basis, any adverse changes in the financial condition of the issuers and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value. Fair value of financial instruments The Company follows ASC 820, Fair Value Measurements and Disclosures (ASC 820), to measure the fair value of its financial statements and disclosures about fair value of its financial instruments. ASC 820 establishes a framework for measuring fair value in GAAP, and expands disclosures about fair value measurements. Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase consistency and comparability in fair value measurements and related disclosures, ASC 820 establishes a fair value hierarchy which prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The three levels of fair value hierarchy defined by ASC 820 are described below: Level 1 : Quoted market prices available in active markets for identical assets or liabilities as of the reporting date. Level 2 : Pricing inputs other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reporting date. Level 3 : Pricing inputs that are generally unobservable inputs and not corroborated by market data. The fair value hierarchy gives the highest priority to quoted prices (unadjusted) in active markets for identical assets or liabilities and the lower priority to unobservable inputs. If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument. The Company uses this framework for measuring fair value and disclosures about fair value measurement. The Company uses fair value measurements in areas that include derivative instruments. The Company recognizes transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. The carrying amounts reported in the balance sheets for cash and cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses, and note payable approximate their fair value based on the short-term maturity of these instruments. Property and equipment Property and equipment are stated at cost. The Company commences depreciation when the asset is placed in service. Computers and peripheral equipment are depreciated on a straight-line method over useful lives of three years. Leases The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to use, or control the use of, identified property, plant, or equipment for a period of time in exchange for consideration. Leases may be classified as finance leases or operating leases. Lease right-of-use (ROU) assets and lease liabilities recognized in the accompanying balance sheet represent the right to use an underlying asset for the lease term and an obligation to make lease payments arising from the lease respectively. At each reporting date, the finance lease liabilities are increased by interest and reduced by repayments made under the lease agreements. The ROU asset is subsequently measured at the amount of the remeasured lease liability (i.e. the present value of the remaining lease payments), any cumulative prepaid or accrued rent if the lease payments are uneven throughout the lease term, and any unamortized initial direct costs. Warrant Liabilities, Change in Fair Value and Warrant Conversion The Company evaluated the warrants issued in connection with the May 2022 registered direct financing (Note 10) in accordance with ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity (ASC 815-40), and concluded that a provision in the warrants related to the reduction of the exercise price in certain circumstances precludes the warrants from being accounted for as components of equity. As the warrants meet the definition of a derivative as contemplated in ASC 815, the warrants are recorded as derivative liabilities on the accompanying Balance Sheets and measured at fair value at inception and at each reporting date in accordance with ASC 820, Fair Value Measurement, with changes in fair value recognized in the accompanying Statements of Operations and Comprehensive Loss in the period of change. The derivative liabilities will ultimately be converted into the Company’s common stock when the warrants are exercised, or will be extinguished upon expiry of the warrant term. Upon exercise, the intrinsic value of the shares issued is transferred to stockholders’ equity. The difference between the intrinsic value of the stock issued and the fair value of the warrant is recorded as gain or loss on the exchange in the accompanying Statements of Operations and Comprehensive Loss in the period of exercise. Research and development Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including third party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. Stock-based compensation The Company recognizes expense for employee and non-employee stock-based compensation in accordance with ASC Topic 718, Stock-Based Compensation (ASC 718). ASC 718 requires that such transactions be accounted for using a fair value-based method. The estimated fair value of the options is amortized over the vesting period, based on the fair value of the options on the date granted, and is calculated using the Black-Scholes option-pricing model. The Company accounts for forfeitures as incurred. In considering the fair value of the underlying stock when the Company granted options, the Company considered several factors including the fair values established by market transactions. Stock option-based compensation includes estimates and judgments of when stock options might be exercised and stock price volatility. The timing of option exercises is out of the Company's control and depends upon a number of factors including the Company's market value and the financial objectives of the option holders. These estimates can have a material impact on the stock compensation expense but will have no impact on the cash flows. The estimation of share-based awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative adjustment in the period the estimates are revised. The Company uses the expected term, rather than the contractual term, for both employee and consultant options issued. Derivative instruments The Company evaluated its convertible notes to determine if those contracts or embedded components of those contracts qualified as derivatives to be separately accounted for in accordance with ASC 815, Derivatives and Hedging . The result of this accounting treatment is that the fair value of the embedded derivative is marked to market each balance sheet date and recorded as a liability. In the event that the fair value is recorded as a liability, the change in fair value is recorded in the statements of operations as other income or expense. Upon conversion or exercise of a derivative instrument, the instrument is marked to fair value at the conversion date and then that fair value is reclassified to equity. In circumstances where the embedded conversion option in a convertible instrument is required to be bifurcated and there are also other embedded derivative instruments in the convertible instrument that are required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument. Equity instruments that are initially classified as equity that become subject to reclassification are reclassified to liability at the fair value of the instrument on the reclassification date. Derivative instrument liabilities are classified in the balance sheets as current or non-current to correspond with its host instrument. Income taxes Income taxes are accounted for under the asset and liability method. The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company's assets and liabilities and the expected benefits of net operating loss carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the period in which temporary differences are expected to be settled, is reflected in the Company's financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on the weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. As of December 31, 2022 and 2021, the Company concluded that a full valuation allowance was necessary for all of its net deferred tax assets. The Company had no amounts recorded for uncertain tax positions, interest or penalties in the accompanying consolidated financial statements. Net loss per common share Basic net loss per common share is computed based on the weighted average number of shares of common stock outstanding during each year. Diluted net loss per common share is computed based on the weighted average number of shares of common stock outstanding during each year, plus the dilutive effect of options considered to be outstanding during each year, in accordance with ASC 260, Earnings Per Share . Recent accounting pronouncements The Company considers the applicability and impact of all ASUs. ASUs not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the financial statements. On January 1, 2022, the Company adopted ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) . ASU 2020-06 address issues identified as a result of the complexity associated with applying generally accepted accounting principles (GAAP) for certain financial instruments with characteristics of liabilities and equity.The amendments focused on amending the guidance on convertible instruments and the guidance on the derivatives scope exception for contracts in an entity’s own equity. The adoption of this standard did not have a material impact on the Company’s financial statements. On January 1, 2021, the Company adopted ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
MARKETABLE SECURITIES AND FAIR
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS | MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS Marketable Securities The following is a summary of the Company’s available-for-sale securities as of the dates indicated: As of December 31, 2021 Adjusted Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Marketable Securities: Debt securities: Corporate bonds $ 1,153 $ — $ (1) $ 1,152 Municipal bonds 2,657 — (1) 2,656 Total $ 3,810 $ — $ (2) $ 3,808 The Company had no available-for-sale securities as of December 31, 2022. Fair Value Measurements Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase consistency and comparability in fair value measurements and related disclosures, ASC 820, Fair Value Measurement , establishes a fair value hierarchy which prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The three levels of fair value hierarchy defined by ASC 820 are described below: Level 1 : Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Level 2 : Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liabilities. Level 3 : Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). As of December 31, 2022, the Company’s financial instruments included cash and cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses, and the warrant liability. The carrying amounts reported in the balance sheets for cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair value based on the short-term maturity of these instruments. The Company recognizes transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. The following table presents, for each of the fair value hierarchy levels required under ASC 820, the Company’s liabilities that are measured at fair value on a recurring basis as of the dates indicated: As of December 31, 2022 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Other Unobservable Inputs (Level 3) Liabilities: Warrant liability $ — $ — $ 122 As of December 31, 2021 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Other Unobservable Inputs (Level 3) Assets: Marketable securities, available-for-sale $ — $ 3,808 $ — On May 17, 2022, the Company issued 3,700,000 shares of common stock pursuant to a securities purchase agreement at a purchase price of $1.0632 per share in a registered direct offering (Note 10). In connection with the registered direct offering, the Company issued warrants to purchase an aggregate of 3,700,000 shares of common stock at an exercise price of $0.9382 per share (May 2022 Warrant Agreement). The warrants were classified as a liability in accordance with ASC 815-40 and the fair value of $122 is reflected in warrant liability on the accompanying Balance Sheets. The warrant liability was measured at fair value at inception and is revalued at each financial statement date, with changes in fair value presented within change in fair value of warrant liability in the accompanying Statements of Operations and Comprehensive Loss. The May 2022 Warrant Agreement entitled the holders to receive one share of common stock for each warrant in lieu of the aggregate number of shares of common stock that would have been received using the cashless exercise formula set forth in the May 2022 Warrant Agreement (Alternate Cashless Exercise) at a specified future date. In July 2022, the Company amended the terms of the May 2022 Warrant Agreement to obligate each warrant holder who signed the warrant amendment (Applicable Holder) to effect an Alternate Cashless Exercise, in whole, by August 10, 2022 (the Expiration Date). If the warrants held by the Applicable Holders were not exercised by the Expiration Date, they were automatically exercised pursuant to the Alternate Cashless Exercise. A total of 2,220,000 warrants were exercised pursuant to the May 2022 Warrant Agreement amendment. In December 2022, an additional 740,000 warrants were exercised pursuant to the Alternate Cashless Exercise under the original terms of the May 2022 Warrant Agreement. As a result of the warrant conversions, the Company recognized a $782 reversal of the warrant liability. The following table presents the changes is the fair value of the Level 3 liability: Warrant Liability Fair value as of December 31, 2021 $ — Initial measurement on May 17, 2022 1,288 Warrant conversion (782) Change in valuation (384) Balance as of December 31, 2022 $ 122 The Black-Scholes valuation model was used to estimate the fair value of the warrants with the following weighted-average assumptions: (Initial Measurement) May 17, 2022 December 31, 2022 Volatility 130.8 % 133.3 % Expected term in years 2.5 2.5 Dividend rate 0.0 % 0.0 % Risk-free interest rate 2.665 % 4.240 % The fair value of the embedded derivative liability identified in the 2021 Convertible Notes was a Level 3 fair value measurement. As of February 12, 2021, the embedded derivative was remeasured based upon the conversion price of $8.00 per share upon closing of the IPO. As such, an expense of $89 was recorded in the first quarter of 2021. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
LEASES | LEASES The Company had a financing lease in relation to equipment utilized in the commercial scale manufacturing of ADAIR. The Company evaluates renewal options at lease inception on an ongoing basis and includes renewal options that it is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. Lease agreements generally do not require material variable lease payments, residual value guarantees or restrictive covenants. Financing lease ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of minimum lease payments over the lease term. The Company utilized the interest rate implicit in the lease. The lease term was based on the non-cancellable period in the lease contract. Termination fees are included in the calculation of the ROU asset and lease liability when it is assumed that the lease will be terminated. The table below presents the finance lease assets and liabilities recognized on the Company's balance sheets: December 31, Balance Sheet Line Item 2022 2021 Non-current finance lease assets Other assets $ — $ 206 Finance lease liabilities: Current finance lease liabilities Other current liabilities — 97 Non-current finance lease liabilities Other liabilities — 72 Total finance lease liabilities $ — $ 169 During the year ended December 31, 2022, the remaining payments due under the Company’s financing lease were accelerated and included in accounts payable. As a result, as of December 31, 2022, the Company had no finance lease assets or liabilities. Cash flows related to the measurement of financing lease assets and liabilities were as follows: Year Ended December 31, 2022 2021 Operating cash flows from finance lease amortization $ 206 $ 73 Financing cash flows from finance lease payments $ 15 $ 106 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | ACCRUED EXPENSES Accrued expenses consisted of: December 31, 2022 2021 Accrued expenses: Research and development $ 42 $ 894 General and administrative 268 183 Payroll and related 401 291 Licensing related — 62 Total accrued expenses $ 711 $ 1,430 |
PPP NOTE AND CONVERTIBLE NOTES
PPP NOTE AND CONVERTIBLE NOTES | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
PPP NOTE AND CONVERTIBLE NOTES | PPP NOTE AND CONVERTIBLE NOTESIn May 2020, the Company issued a promissory note under the PPP (the PPP Note) totaling $61. The note had a stated interest rate of 1% and had a two-year maturity. Payments were required to be made over a 1.5 years period beginning in November 2020 unless forgiven. In January 2021, the Company was notified that the loan along with accumulated interest had been forgiven. As a result, the Company recorded income from the extinguishment of its obligation in the amount of $61 as other income on the accompanying Statements of Operations and Comprehensive Loss.In January 2021, the Company entered into a Convertible Promissory Note Purchase Agreement with certain existing stockholders, including Salmon Pharma, an affiliate of Medice, and David Baker, the Company’s Chief Executive Officer, pursuant to which the Company issued the 2021 Convertible Notes, for cash proceeds of $350. The 2021 Convertible Notes bore an interest rate of 7.0% per annum, non-compounding, and had a maturity date of September 30, 2021. The 2021 Convertible Notes converted into 54,906 shares of the Company’s common stock upon completion of the IPO. The Company identified the mandatory conversion into shares of the Company’s common stock as a redemption feature, which requires bifurcation from the 2021 Convertible Notes and treated it as a derivative liability under ASC 815 as the redemption feature was not clearly and closely related to the debt. The Company evaluated the fair value of the derivative liability. Upon the conversion of the 2021 Convertible Notes to common stock at the closing of the IPO, the embedded derivative liability was remeasured and removed from the balance sheet. |
EMPLOYEE BENEFIT PLANS
EMPLOYEE BENEFIT PLANS | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
EMPLOYEE BENEFIT PLANS | EMPLOYEE BENEFIT PLANSThe Company maintains a tax-qualified SIMPLE IRA retirement plan which covers all employees. Pursuant to the SIMPLE IRA program, employees are eligible to contribute to an individual SIMPLE IRA account on a tax-deferred basis. The Company makes matching contributions to the employee’s SIMPLE IRA account in an amount up to 3% of the employee’s base salary (subject to applicable IRS compensation limits). Expenses related to Company contributions were $21 and $24 for the years ended December 31, 2022 and 2021, respectively. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Employment agreements The Company has entered into employment contracts with its officers that provide for severance and continuation of benefits in the event of termination of employment by the Company without cause or by the employee for good reason. In addition, in the event of termination of employment following a change in control, the vesting of certain equity awards may be accelerated. Litigation In November 2021, the Company was named as a defendant in a putative class action lawsuit filed in the California Superior Court, County of Los Angeles, styled Rendon v. Vallon, Inc., et al . The complaint brought one claim for violation of California’s Unruh Civil Rights Act (Unruh Act), alleging that the Company’s website is not compatible with software used by vision-impaired individuals. The Company settled the lawsuit for an immaterial amount . COVID-19 Impact The global COVID-19 pandemic continues to present uncertainty and unforeseeable new risks to the Company’s operations and business plan. The Company has closely monitored recent COVID-19 developments, including states’ lifting COVID-19 safety measures, drops in vaccination rates, and the spread of various coronavirus strains such as the Delta and Omicron variants. In light of these developments, the full impact of the COVID-19 pandemic on the Company’s business, operations and clinical development plans remains uncertain and will vary depending on the pandemic’s future impact on its clinical trial enrollment, clinical trial sites, clinical research organizations (CROs), third-party manufacturers, and other third parties with whom the Company does business, as well as any legal or regulatory consequences resulting therefrom. To the extent possible, the Company is conducting business as usual, with necessary or advisable modifications to employee travel and with most of its employees and consultants working remotely. The Company will continue to actively monitor the COVID-19 situation and may take further actions that alter its operations, including those that may be required by federal, state or local authorities, or that it determines is in the best interests of its employees and other third parties with whom the Company does business. |
STOCKHOLDERS EQUITY (DEFICIT)
STOCKHOLDERS EQUITY (DEFICIT) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS EQUITY (DEFICIT) | STOCKHOLDERS EQUITY (DEFICIT) Common Stock In February 2021, the Company completed its IPO of 2,250,000 shares of common stock at a public offering price of $8.00 per share. As a result of the IPO, the Company received approximately $15,500 in net proceeds, after deducting discounts and commissions of $1,600 and offering expenses of approximately $905. On May 17, 2022, the Company sold 3,700,000 shares of common stock pursuant to a securities purchase agreement at a purchase price of $1.0632 per share in a registered direct offering (the Offering). The gross proceeds from the Offering were approximately $3,900, before deducting fees payable to the placement agent and other estimated offering expenses payable by the Company of approximately $572 of which $85 related to the warrants was expensed. Common Stock Warrants In connection with the IPO, the Company granted the underwriters warrants (the Underwriters' Warrants) to purchase an aggregate of 112,500 shares of common stock at an exercise price of $10.00 per share. The Underwriters’ Warrants have a five-year term and became exercisable after August 12, 2021. The warrants were classified as equity and the fair value of $399 is reflected as additional paid-in capital. The Black-Scholes option-pricing model was used to estimate the fair value of the warrants with the following weighted-average assumptions: Volatility 85.0 % Expected term in years 2.5 Dividend rate 0.0 % Risk-free interest rate 0.155 % In connection with the Offering, the Company issued warrants to purchase an aggregate of 3,700,000 shares of common stock at an exercise price of $0.9382 per share (May 2022 Warrant Agreement). The warrants have a five-year term. The warrants were classified as a liability and are revalued at each balance sheet date. The May 2022 Warrant Agreement entitled the holders to receive one share of common stock for each warrant in lieu of the aggregate number of shares of common stock that would have been received using the cashless exercise formula set forth in the May 2022 Warrant Agreement (Alternate Cashless Exercise). In July 2022, the Company amended the terms of the May 2022 Warrant Agreement to obligate each warrant holder who signed the warrant amendment (Applicable Holder) to effect an Alternate Cashless Exercise, in whole, by August 10, 2022 (the Expiration Date). If the warrants held by the Applicable Holders were not exercised by the Expiration Date, they were automatically exercised pursuant to the Alternate Cashless Exercise. A total of 2,220,000 warrants were exercised pursuant to the May 2022 Warrant Agreement amendment. In December 2022, an additional 740,000 warrants were exercised pursuant to the Alternate Cashless Exercise under the original terms of the May 2022 Warrant Agreement. As a result of the warrant conversions, the Company recognized a $782 reversal of the warrant liability and a loss of $506. The fair value of $122 as of December 31, 2022 is reflected in warrant liability on the accompanying Balance Sheets (Note 4). As of December 31, 2022, the Company had the following warrants outstanding to purchase common stock. Number of Shares Exercise Price per Share Expiration Date 112,500 $10.00 February 12, 2026 740,000 $0.9382 May 17, 2027 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION The Company recorded stock-based compensation related to stock options and restricted stock units (RSUs) issued under the Company’s 2018 Equity Incentive Plan (2018 Plan) in the following expense categories of its accompanying statements of operations for the years ended December 31, 2022 and 2021: For the Year Ended December 31, 2022 2021 Research and development $ (202) $ 83 General and administrative 301 543 Total $ 99 $ 626 Stock Options The Company has granted stock options to purchase its common stock to employees and consultants under the 2018 Plan, under which the Company may issue stock options, restricted stock and other equity-based awards. The Company has also granted certain stock options outside of the 2018 Plan. Stock options granted by the Company generally have a contractual life of up to 10 years. The Company measures equity-based awards granted to employees, and non-employees based on their fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period or performance-based period, which is generally the vesting period of the respective award. The measurement date for service-based equity awards is the date of grant, and equity-based compensation costs are recognized as expense over the requisite service period, which is the vesting period for certain performance-based awards. The Company records expense for performance-based awards if it concludes that it is probable that the performance condition will be achieved. During the year ended December 31, 2022, the Company reversed stock based compensation related to performance awards with performance conditions deemed not probable of achievement. The table below represents the activity of stock options granted to employees and non-employees for the year ended December 31, 2022: Number of options Weighted average exercise price Weighted average remaining contractual term (years) Outstanding at December 31, 2021 708,490 $ 3.60 8.64 Granted 204,500 $ 5.22 Exercised — — Forfeited (218,750) 4.06 Outstanding at December 31, 2022 694,240 $ 3.94 8.05 Exercisable at December 31, 2022 338,490 $ 3.38 7.60 Vested and expected to vest at December 31, 2022 605,178 $ 3.91 8.12 The Black-Scholes option-pricing model was used to estimate the grant date fair value of each stock option grant at the time of grant using the following weighted-average assumptions: For the Year Ended December 31, 2022 2021 Volatility 90.39 % 83.78 % Expected term in years 5.98 5.85 Dividend rate 0.00 % 0.00 % Risk-free interest rate 2.00 % 1.01 % Fair value of common stock on grant date $ 3.86 $ 4.00 As of December 31, 2022, all of the outstanding and exercisable stock options were out of the money and therefore had no intrinsic value. At December 31, 2022, the unrecognized compensation cost related to unvested stock options expected to vest was $753. This unrecognized compensation is expected to be recognized over a weighted-average amortization period of 2.64 years. Restricted Stock Units The Company has issued performance-based and time-based RSUs. Vesting of the performance-based RSUs is subject to the achievement of certain milestones. The following table summarizes the activity related to RSUs granted to employees for the year ended December 31, 2022: Shares Outstanding at December 31, 2021 — Granted 188,023 Vested and settled (9,406) Expired/forfeited/canceled (178,517) Outstanding at December 31, 2022 — During the year ended December 31, 2022, the Company granted 188,023 RSUs at a weighted average grant date fair value of $0.5683, of which 150,000 were performance-based RSUs and 38,023 were time-based RSUs. In December 2022, all unvested RSUs were canceled. Upon cancellation, fifty percent of the milestones associated |
INCOME TAX
INCOME TAX | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
INCOME TAX | INCOME TAX A reconciliation of income tax expense (benefit) at the US federal statutory income tax rate and the income tax provision in the financial statements is as follows: December 31, 2022 2021 Expected income tax benefit at the federal statutory rate 21.0 % 21.0 % State and local taxes, net of federal benefit 10.8 10.6 Non-deductible items and other (0.8) (0.5) Change in valuation allowance (31.0) (31.1) Total — % — % Deferred income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The principal components of the Company’s deferred tax assets and liabilities are as follows: December 31, 2022 2021 Deferred tax assets: Federal and state net operating loss carryforwards $ 8,346 $ 6,617 Share based compensation 342 308 Lease liabilities 55 57 Research and development costs 315 — Accruals and other 136 98 Gross deferred tax assets 9,194 7,080 Less: deferred tax liabilities — (70) Less: valuation allowance (9,194) (7,010) Net deferred tax assets $ — $ — Based on the Company’s history of losses, the Company recorded a full valuation allowance against its deferred tax assets as of December 31, 2022 and 2021. The Company increased its valuation allowance by approximately $2,184 for the year ended December 31, 2022. The Company intends to maintain a valuation allowance until sufficient positive evidence exists to support a reversal of the allowance. As of December 31, 2022, the Company had federal, state and local net operating loss carryforwards of $25,635, $25,925, and $18,560, respectively. The federal net operating loss carryforwards do not expire. The state and local losses begin to expire in the year ending December 31, 2038. Under the provisions of Sections 382 and 383 of the Internal Revenue Code (IRC), certain substantial changes in the Company’s ownership may have limited, or may limit in the future, the amount of net operating loss and credit carryforwards that can be used to reduce future income taxes if there has been a significant change in ownership of the Company, as defined by the IRC. Future owner or equity shifts could result in limitations on net operating loss and credit carryforwards. The Company evaluates tax positions for recognition using a more-likely-than-not recognition threshold, and those tax positions eligible for recognition are measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon the effective settlement with a taxing authority that has full knowledge of all relevant |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | RELATED PARTY TRANSACTIONSIn January 2021, the Company entered into a Convertible Promissory Note Purchase Agreement with certain existing stockholders, including Salmon Pharma, an affiliate of Medice, and David Baker, the Company’s Chief Executive Officer, pursuant to which the Company issued the 2021 Convertible Notes for cash proceeds of $350. The 2021 Convertible Notes bore an interest rate of 7.0% per annum, non-compounding, and had a maturity date of September 30, 2021. The 2021 Convertible Notes converted into 54,906 shares of the Company’s common stock upon completion of the IPO. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Use of estimates | Use of estimatesThe preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Estimates and assumptions are primarily made in relation to the valuation of share options, the embedded derivative of convertible notes, warrant issuance and subsequent revaluations, valuation allowances relating to deferred tax assets, revenue recognition, accrued expenses and estimation of the incremental borrowing rate for the finance lease. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate. |
Concentration of credit risk | Concentration of credit risk The Company from time to time during the period covered by these financial statements may have had bank account balances in excess of federally insured limits. The Company has not experienced losses in such accounts. The Company believes that it is not subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. |
Cash equivalents | Cash equivalentsCash equivalents are highly-liquid investments that are readily convertible into cash with original maturities of three months or less when purchased and as of December 31, 2022 and 2021 included investment in money market funds. |
Marketable securities | Marketable securities Marketable securities consist of debt securities that are designated as available-for-sale. Amortization of premiums and discounts on marketable securities are included in interest expense, net on the statements of operations and comprehensive loss. Realized gains or losses resulting from the sale of these securities are determined based on the specific identification of the securities sold. An impairment charge is recognized when the decline in the fair value of a debt security below the amortized cost basis is determined to be other-than-temporary. The Company considers various factors in determining whether to recognize an impairment charge, including the duration and severity of any decline in fair value below the amortized cost basis, any adverse changes in the financial condition of the issuers and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value. |
Fair value of financial instruments | Fair value of financial instruments The Company follows ASC 820, Fair Value Measurements and Disclosures (ASC 820), to measure the fair value of its financial statements and disclosures about fair value of its financial instruments. ASC 820 establishes a framework for measuring fair value in GAAP, and expands disclosures about fair value measurements. Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase consistency and comparability in fair value measurements and related disclosures, ASC 820 establishes a fair value hierarchy which prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The three levels of fair value hierarchy defined by ASC 820 are described below: Level 1 : Quoted market prices available in active markets for identical assets or liabilities as of the reporting date. Level 2 : Pricing inputs other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reporting date. Level 3 : Pricing inputs that are generally unobservable inputs and not corroborated by market data. The fair value hierarchy gives the highest priority to quoted prices (unadjusted) in active markets for identical assets or liabilities and the lower priority to unobservable inputs. If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument. The Company uses this framework for measuring fair value and disclosures about fair value measurement. The Company uses fair value measurements in areas that include derivative instruments. |
Property and equipment | Property and equipmentProperty and equipment are stated at cost. The Company commences depreciation when the asset is placed in service. Computers and peripheral equipment are depreciated on a straight-line method over useful lives of three years. |
Leases | Leases The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to use, or control the use of, identified property, plant, or equipment for a period of time in exchange for consideration. Leases may be classified as finance leases or operating leases. Lease right-of-use (ROU) assets and lease liabilities recognized in the accompanying balance sheet represent the right to use an underlying asset for the lease term and an obligation to make lease payments arising from the lease respectively. At each reporting date, the finance lease liabilities are increased by interest and reduced by repayments made under the lease agreements. The ROU asset is subsequently measured at the amount of the remeasured lease liability (i.e. the present value of the remaining lease payments), any cumulative prepaid or accrued rent if the lease payments are uneven throughout the lease term, and any unamortized initial direct costs. |
Warrant Liabilities, Change in Fair Value and Warrant Conversion and Derivative instruments | Warrant Liabilities, Change in Fair Value and Warrant Conversion The Company evaluated the warrants issued in connection with the May 2022 registered direct financing (Note 10) in accordance with ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity (ASC 815-40), and concluded that a provision in the warrants related to the reduction of the exercise price in certain circumstances precludes the warrants from being accounted for as components of equity. As the warrants meet the definition of a derivative as contemplated in ASC 815, the warrants are recorded as derivative liabilities on the accompanying Balance Sheets and measured at fair value at inception and at each reporting date in accordance with ASC 820, Fair Value Measurement, with changes in fair value recognized in the accompanying Statements of Operations and Comprehensive Loss in the period of change. The derivative liabilities will ultimately be converted into the Company’s common stock when the warrants are exercised, or will be extinguished upon expiry of the warrant term. Upon exercise, the intrinsic value of the shares issued is transferred to stockholders’ equity. The difference between the intrinsic value of the stock issued and the fair value of the warrant is recorded as gain or loss on the exchange in the accompanying Statements of Operations and Comprehensive Loss in the period of exercise. Derivative instruments The Company evaluated its convertible notes to determine if those contracts or embedded components of those contracts qualified as derivatives to be separately accounted for in accordance with ASC 815, Derivatives and Hedging . The result of this accounting treatment is that the fair value of the embedded derivative is marked to market each balance sheet date and recorded as a liability. In the event that the fair value is recorded as a liability, the change in fair value is recorded in the statements of operations as other income or expense. Upon conversion or exercise of a derivative instrument, the instrument is marked to fair value at the conversion date and then that fair value is reclassified to equity. In circumstances where the embedded conversion option in a convertible instrument is required to be bifurcated and there are also other embedded derivative instruments in the convertible instrument that are required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument. Equity instruments that are initially classified as equity that become subject to reclassification are reclassified to liability at the fair value of the instrument on the reclassification date. Derivative instrument liabilities are classified in the balance sheets as current or non-current to correspond with its host instrument. |
Research and development | Research and developmentResearch and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including third party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. |
Stock-based compensation | Stock-based compensation The Company recognizes expense for employee and non-employee stock-based compensation in accordance with ASC Topic 718, Stock-Based Compensation (ASC 718). ASC 718 requires that such transactions be accounted for using a fair value-based method. The estimated fair value of the options is amortized over the vesting period, based on the fair value of the options on the date granted, and is calculated using the Black-Scholes option-pricing model. The Company accounts for forfeitures as incurred. In considering the fair value of the underlying stock when the Company granted options, the Company considered several factors including the fair values established by market transactions. Stock option-based compensation includes estimates and judgments of when stock options might be exercised and stock price volatility. The timing of option exercises is out of the Company's control and depends upon a number of factors including the Company's market value and the financial objectives of the option holders. These estimates can have a material impact on the stock compensation expense but will have no impact on the cash flows. The estimation of share-based awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative adjustment in the period the estimates are revised. The Company uses the expected term, rather than the contractual term, for both employee and consultant options issued. |
Income taxes | Income taxesIncome taxes are accounted for under the asset and liability method. The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company's assets and liabilities and the expected benefits of net operating loss carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the period in which temporary differences are expected to be settled, is reflected in the Company's financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on the weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. As of December 31, 2022 and 2021, the Company concluded that a full valuation allowance was necessary for all of its net deferred tax assets. The Company had no amounts recorded for uncertain tax positions, interest or penalties in the accompanying consolidated financial statements. |
Net loss per common share | Net loss per common share Basic net loss per common share is computed based on the weighted average number of shares of common stock outstanding during each year. Diluted net loss per common share is computed based on the weighted average number of shares of common stock outstanding during each year, plus the dilutive effect of options considered to be outstanding during each year, in accordance with ASC 260, Earnings Per Share |
Recent accounting pronouncements | Recent accounting pronouncements The Company considers the applicability and impact of all ASUs. ASUs not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the financial statements. On January 1, 2022, the Company adopted ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) . ASU 2020-06 address issues identified as a result of the complexity associated with applying generally accepted accounting principles (GAAP) for certain financial instruments with characteristics of liabilities and equity.The amendments focused on amending the guidance on convertible instruments and the guidance on the derivatives scope exception for contracts in an entity’s own equity. The adoption of this standard did not have a material impact on the Company’s financial statements. On January 1, 2021, the Company adopted ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
MARKETABLE SECURITIES AND FAI_2
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Debt Securities, Available-for-sale | The following is a summary of the Company’s available-for-sale securities as of the dates indicated: As of December 31, 2021 Adjusted Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Marketable Securities: Debt securities: Corporate bonds $ 1,153 $ — $ (1) $ 1,152 Municipal bonds 2,657 — (1) 2,656 Total $ 3,810 $ — $ (2) $ 3,808 |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following table presents, for each of the fair value hierarchy levels required under ASC 820, the Company’s liabilities that are measured at fair value on a recurring basis as of the dates indicated: As of December 31, 2022 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Other Unobservable Inputs (Level 3) Liabilities: Warrant liability $ — $ — $ 122 As of December 31, 2021 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Other Unobservable Inputs (Level 3) Assets: Marketable securities, available-for-sale $ — $ 3,808 $ — |
Schedule of Activity for the Liability Measured at Estimated Fair Value Using Unobservable Inputs | The following table presents the changes is the fair value of the Level 3 liability: Warrant Liability Fair value as of December 31, 2021 $ — Initial measurement on May 17, 2022 1,288 Warrant conversion (782) Change in valuation (384) Balance as of December 31, 2022 $ 122 |
Fair Value Measurement Inputs and Valuation Techniques | The Black-Scholes valuation model was used to estimate the fair value of the warrants with the following weighted-average assumptions: (Initial Measurement) May 17, 2022 December 31, 2022 Volatility 130.8 % 133.3 % Expected term in years 2.5 2.5 Dividend rate 0.0 % 0.0 % Risk-free interest rate 2.665 % 4.240 % Volatility 85.0 % Expected term in years 2.5 Dividend rate 0.0 % Risk-free interest rate 0.155 % |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Schedule of Finance Lease Cost | The table below presents the finance lease assets and liabilities recognized on the Company's balance sheets: December 31, Balance Sheet Line Item 2022 2021 Non-current finance lease assets Other assets $ — $ 206 Finance lease liabilities: Current finance lease liabilities Other current liabilities — 97 Non-current finance lease liabilities Other liabilities — 72 Total finance lease liabilities $ — $ 169 During the year ended December 31, 2022, the remaining payments due under the Company’s financing lease were accelerated and included in accounts payable. As a result, as of December 31, 2022, the Company had no finance lease assets or liabilities. Cash flows related to the measurement of financing lease assets and liabilities were as follows: Year Ended December 31, 2022 2021 Operating cash flows from finance lease amortization $ 206 $ 73 Financing cash flows from finance lease payments $ 15 $ 106 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of: December 31, 2022 2021 Accrued expenses: Research and development $ 42 $ 894 General and administrative 268 183 Payroll and related 401 291 Licensing related — 62 Total accrued expenses $ 711 $ 1,430 |
STOCKHOLDERS EQUITY (DEFICIT) (
STOCKHOLDERS EQUITY (DEFICIT) (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Fair Value Measurement Inputs and Valuation Techniques | The Black-Scholes valuation model was used to estimate the fair value of the warrants with the following weighted-average assumptions: (Initial Measurement) May 17, 2022 December 31, 2022 Volatility 130.8 % 133.3 % Expected term in years 2.5 2.5 Dividend rate 0.0 % 0.0 % Risk-free interest rate 2.665 % 4.240 % Volatility 85.0 % Expected term in years 2.5 Dividend rate 0.0 % Risk-free interest rate 0.155 % |
Schedule of Warrants Outstanding To Purchase Common Stock | As of December 31, 2022, the Company had the following warrants outstanding to purchase common stock. Number of Shares Exercise Price per Share Expiration Date 112,500 $10.00 February 12, 2026 740,000 $0.9382 May 17, 2027 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expense | The Company recorded stock-based compensation related to stock options and restricted stock units (RSUs) issued under the Company’s 2018 Equity Incentive Plan (2018 Plan) in the following expense categories of its accompanying statements of operations for the years ended December 31, 2022 and 2021: For the Year Ended December 31, 2022 2021 Research and development $ (202) $ 83 General and administrative 301 543 Total $ 99 $ 626 |
Activity of Stock Options Granted | The table below represents the activity of stock options granted to employees and non-employees for the year ended December 31, 2022: Number of options Weighted average exercise price Weighted average remaining contractual term (years) Outstanding at December 31, 2021 708,490 $ 3.60 8.64 Granted 204,500 $ 5.22 Exercised — — Forfeited (218,750) 4.06 Outstanding at December 31, 2022 694,240 $ 3.94 8.05 Exercisable at December 31, 2022 338,490 $ 3.38 7.60 Vested and expected to vest at December 31, 2022 605,178 $ 3.91 8.12 |
Schedule of Valuation Assumptions | The Black-Scholes option-pricing model was used to estimate the grant date fair value of each stock option grant at the time of grant using the following weighted-average assumptions: For the Year Ended December 31, 2022 2021 Volatility 90.39 % 83.78 % Expected term in years 5.98 5.85 Dividend rate 0.00 % 0.00 % Risk-free interest rate 2.00 % 1.01 % Fair value of common stock on grant date $ 3.86 $ 4.00 |
Summary of Restricted Stock Unit Activity | The following table summarizes the activity related to RSUs granted to employees for the year ended December 31, 2022: Shares Outstanding at December 31, 2021 — Granted 188,023 Vested and settled (9,406) Expired/forfeited/canceled (178,517) Outstanding at December 31, 2022 — |
INCOME TAX (Tables)
INCOME TAX (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Federal Statutory Income Tax Rate to the Effective Income tax Rate | A reconciliation of income tax expense (benefit) at the US federal statutory income tax rate and the income tax provision in the financial statements is as follows: December 31, 2022 2021 Expected income tax benefit at the federal statutory rate 21.0 % 21.0 % State and local taxes, net of federal benefit 10.8 10.6 Non-deductible items and other (0.8) (0.5) Change in valuation allowance (31.0) (31.1) Total — % — % |
Schedule of Deferred Tax Assets | The principal components of the Company’s deferred tax assets and liabilities are as follows: December 31, 2022 2021 Deferred tax assets: Federal and state net operating loss carryforwards $ 8,346 $ 6,617 Share based compensation 342 308 Lease liabilities 55 57 Research and development costs 315 — Accruals and other 136 98 Gross deferred tax assets 9,194 7,080 Less: deferred tax liabilities — (70) Less: valuation allowance (9,194) (7,010) Net deferred tax assets $ — $ — |
ORGANIZATION AND DESCRIPTION _2
ORGANIZATION AND DESCRIPTION OF BUSINESS (Details) - $ / shares | Dec. 31, 2022 | Dec. 13, 2022 | May 17, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||||
Common stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 |
GRI | ||||
Class of Stock [Line Items] | ||||
Common stock, par value (in usd per share) | $ 0.01 |
LIQUIDITY (Details)
LIQUIDITY (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
May 17, 2022 | Feb. 12, 2021 | Jan. 11, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 13, 2022 | |
Class of Stock [Line Items] | ||||||
Accumulated deficit | $ 28,926 | $ 21,902 | ||||
Proceeds from convertible notes | $ 350 | $ 0 | $ 350 | |||
Net proceeds from sale of stock | $ 3,900 | |||||
Sale of stock (in shares) | 3,700,000 | |||||
Common stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Sale of stock, price per share (in usd per share) | $ 1.0632 | |||||
Stock issuance costs | $ 572 | |||||
Warrants issuance expense | $ 85 | |||||
Cash and cash equivalents | $ 3,781 | $ 3,702 | ||||
IPO | ||||||
Class of Stock [Line Items] | ||||||
Net proceeds from sale of stock | $ 15,500 | |||||
Sale of stock (in shares) | 2,250,000 | |||||
Sale of stock, price per share (in usd per share) | $ 8 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Recapitalization and License Revenue (Details) | Feb. 12, 2021 |
Accounting Policies [Abstract] | |
Reverse stock split | 0.025 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Computers | |
Property, Plant and Equipment [Line Items] | |
Useful lives | three years |
Equipment | |
Property, Plant and Equipment [Line Items] | |
Useful lives | three years |
MARKETABLE SECURITIES AND FAI_3
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Summary of the Company’s Available for Sale Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule of Investments [Line Items] | ||
Adjusted Cost | $ 0 | $ 3,810 |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (2) | |
Fair Value | 3,808 | |
Corporate bonds | ||
Schedule of Investments [Line Items] | ||
Adjusted Cost | 1,153 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (1) | |
Fair Value | 1,152 | |
Municipal bonds | ||
Schedule of Investments [Line Items] | ||
Adjusted Cost | 2,657 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (1) | |
Fair Value | $ 2,656 |
MARKETABLE SECURITIES AND FAI_4
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Liabilities: | ||
Warrant liability | $ 122 | $ 0 |
Marketable securities, available-for-sale | 3,808 | |
Quoted Prices in Active Markets (Level 1) | ||
Liabilities: | ||
Warrant liability | 0 | |
Marketable securities, available-for-sale | 0 | |
Significant Other Observable Inputs (Level 2) | ||
Liabilities: | ||
Warrant liability | 0 | |
Marketable securities, available-for-sale | 3,808 | |
Significant Other Unobservable Inputs (Level 3) | ||
Liabilities: | ||
Warrant liability | $ 122 | |
Marketable securities, available-for-sale | $ 0 |
MARKETABLE SECURITIES AND FAI_5
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||
May 17, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Jul. 31, 2022 | Feb. 12, 2021 | |
Fair Value Disclosures [Abstract] | |||||
Sale of stock (in shares) | 3,700,000 | ||||
Sale of stock, price per share (in usd per share) | $ 1.0632 | ||||
Warrants granted (in shares) | 3,700,000 | ||||
Warrant exercise price (in usd per share) | $ 0.9382 | ||||
Warrant liability | $ 122 | $ 0 | |||
Number of warrants exercised to alternate cashless exercise | 740,000 | 2,220,000 | |||
Warrant conversion reversal | $ (782) | ||||
Conversion price (in usd per share) | $ 8 | ||||
Expense recognized on embedded derivative | $ 89 |
MARKETABLE SECURITIES AND FAI_6
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Liability Measured at Estimated Fair Value (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Warrant conversion | $ (782) |
Warrant Liability | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance, beginning | 0 |
Additions during the year ended December 31, 2021 | 1,288 |
Warrant conversion | (782) |
Change in valuation | (384) |
Balance, ending | $ 122 |
MARKETABLE SECURITIES AND FAI_7
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Derivative Liability Measurement Inputs (Details) | Dec. 31, 2022 | May 17, 2022 |
Volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants outstanding, measurement input | 1.333 | 1.308 |
Expected term in years | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants outstanding, measurement input | 2.5 | 2.5 |
Dividend rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants outstanding, measurement input | 0 | 0 |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants outstanding, measurement input | 0.04240 | 0.02665 |
LEASES - Assets and Liabilities
LEASES - Assets and Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leases [Abstract] | ||
Non-current finance lease assets | $ 0 | $ 206 |
Finance Lease Liability [Abstract] | ||
Current finance lease liabilities | 0 | 97 |
Non-current finance lease liabilities | 0 | 72 |
Total finance lease liabilities | $ 0 | $ 169 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other assets | Other assets |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Other current liabilities | Other current liabilities |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other liabilities | Other liabilities |
Other Information | ||
Operating cash flows from finance lease amortization | $ 206 | $ 73 |
Financing cash flows from finance lease payments | $ 15 | $ 106 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued expenses: | ||
Research and development | $ 42 | $ 894 |
General and administrative | 268 | 183 |
Payroll and related | 401 | 291 |
Licensing related | 0 | 62 |
Accrued Liabilities, Current, Total | $ 711 | $ 1,430 |
PPP NOTE AND CONVERTIBLE NOTES
PPP NOTE AND CONVERTIBLE NOTES (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jan. 11, 2021 | Feb. 28, 2021 | Jan. 31, 2021 | May 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | ||||||
Forgiveness of PPP note | $ 61 | |||||
Proceeds from convertible notes | $ 350 | $ 0 | $ 350 | |||
Salmon Pharma, Affiliate of Medice and David Baker, CEO | Convertible Promissory Note Purchase Agreement | ||||||
Related Party Transaction [Line Items] | ||||||
Note interest rate | 7% | 7% | ||||
Proceeds from convertible notes | $ 350 | $ 350 | ||||
Convertible notes, converted, shares issued (in shares) | 54,906 | 54,906 | ||||
Paycheck Protection Program, CARES Act | ||||||
Related Party Transaction [Line Items] | ||||||
Debt instrument, face amount | $ 61 | |||||
Note interest rate | 1% | |||||
Note maturity | 2 years | |||||
Note, payment period | 1 year 6 months |
EMPLOYEE BENEFIT PLANS (Details
EMPLOYEE BENEFIT PLANS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Defined Contribution Plan Disclosure [Line Items] | ||
Company contributions | $ 21 | $ 24 |
Maximum | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Employer matching contribution, percent of employees' gross pay (up to) | 3% |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Litigation (Details) | Nov. 06, 2021 claim |
Rendon v. Vallon, Inc., et al | Settled Litigation | |
Loss Contingencies [Line Items] | |
Pending claim | 1 |
STOCKHOLDERS EQUITY (DEFICIT) -
STOCKHOLDERS EQUITY (DEFICIT) - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
May 17, 2022 | Feb. 12, 2021 | Feb. 28, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Jul. 31, 2022 | |
Class of Stock [Line Items] | ||||||
Sale of stock (in shares) | 3,700,000 | |||||
Sale of stock, price per share (in usd per share) | $ 1.0632 | |||||
Net proceeds from sale of stock | $ 3,900 | |||||
Stock issuance costs | 572 | |||||
Warrants issuance expense | $ 85 | |||||
Warrants granted (in shares) | 3,700,000 | |||||
Warrant exercise price (in usd per share) | $ 0.9382 | |||||
Warrants outstanding, term | 5 years | |||||
Warrant issued reflected in additional paid-in capital | $ 399 | |||||
Number of warrants exercised to alternate cashless exercise | 740,000 | 2,220,000 | ||||
Warrant conversion reversal | $ (782) | |||||
Loss on warrant conversion | (506) | 0 | ||||
Warrant liability | $ 122 | $ 0 | ||||
IPO | ||||||
Class of Stock [Line Items] | ||||||
Sale of stock (in shares) | 2,250,000 | |||||
Sale of stock, price per share (in usd per share) | $ 8 | |||||
Net proceeds from sale of stock | $ 15,500 | |||||
Stock issuance costs, discounts and commissions | 1,600 | |||||
Additional offering expense | $ 905 | |||||
Underwriters' Allotment | ||||||
Class of Stock [Line Items] | ||||||
Warrants granted (in shares) | 112,500 | |||||
Warrant exercise price (in usd per share) | $ 10 | |||||
Warrants outstanding, term | 5 years | |||||
Warrant issued reflected in additional paid-in capital | $ 399 |
STOCKHOLDERS EQUITY (DEFICIT)_2
STOCKHOLDERS EQUITY (DEFICIT) - Estimate of the Fair Value of the Warrants and Assumptions (Details) | Dec. 31, 2022 | May 17, 2022 |
Volatility | ||
Class of Stock [Line Items] | ||
Warrants outstanding, measurement input | 1.333 | 1.308 |
Volatility | Warrants-IPO | ||
Class of Stock [Line Items] | ||
Warrants outstanding, measurement input | 0.850 | |
Expected term in years | ||
Class of Stock [Line Items] | ||
Warrants outstanding, measurement input | 2.5 | 2.5 |
Expected term in years | Warrants-IPO | ||
Class of Stock [Line Items] | ||
Warrants outstanding, measurement input | 2.5 | |
Dividend rate | ||
Class of Stock [Line Items] | ||
Warrants outstanding, measurement input | 0 | 0 |
Dividend rate | Warrants-IPO | ||
Class of Stock [Line Items] | ||
Warrants outstanding, measurement input | 0 | |
Risk-free interest rate | ||
Class of Stock [Line Items] | ||
Warrants outstanding, measurement input | 0.04240 | 0.02665 |
Risk-free interest rate | Warrants-IPO | ||
Class of Stock [Line Items] | ||
Warrants outstanding, measurement input | 0.00155 |
STOCKHOLDERS EQUITY (DEFICIT)_3
STOCKHOLDERS EQUITY (DEFICIT) - Schedule of Warrants Outstanding to Purchase Common Stock (Details) - $ / shares | Dec. 31, 2022 | May 17, 2022 |
Class of Stock [Line Items] | ||
Exercise Price per Share (in dollars per share) | $ 0.9382 | |
Warrants Expiring In 2026 | ||
Class of Stock [Line Items] | ||
Number of Shares | 112,500 | |
Exercise Price per Share (in dollars per share) | $ 10 | |
Warrants Expiring In 2027 | ||
Class of Stock [Line Items] | ||
Number of Shares | 740,000 | |
Exercise Price per Share (in dollars per share) | $ 938.2000 |
STOCK-BASED COMPENSATION - Sche
STOCK-BASED COMPENSATION - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | $ 99 | $ 626 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | (202) | 83 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | $ 301 | $ 543 |
STOCK-BASED COMPENSATION - Narr
STOCK-BASED COMPENSATION - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding, intrinsic value | $ 0 | |
Unrecognized compensation cost | $ 753 | |
Unrecognized compensation, weighted average amortization period | 2 years 7 months 20 days | |
Stock-based compensation | $ 99 | $ 626 |
Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock awards, contractual life (up to) | 10 years | |
Restricted Stock Units (RSUs) | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | 188,023 | |
Grant date fair value (in usd per share) | $ 0.5683 | |
Outstanding (in shares) | 0 | 0 |
Performance Based RSUs | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | 150,000 | |
Percentage of milestone achieved | 50% | |
Stock-based compensation | $ 42 | |
Time Based RSUs | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | 38,023 | |
Stock-based compensation | $ 24 |
STOCK-BASED COMPENSATION - Acti
STOCK-BASED COMPENSATION - Activity of Stock Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Number of options | ||
Outstanding, Beginning Balance (in shares) | 708,490 | |
Granted (in shares) | 204,500 | |
Exercised (in shares) | 0 | |
Forfeited (in shares) | (218,750) | |
Outstanding, Ending Balance (in shares) | 694,240 | 708,490 |
Exercisable, Ending Balance (in shares) | 338,490 | |
Vested and expected to vest (in shares) | 605,178 | |
Weighted average exercise price | ||
Outstanding, Beginning Balance (in usd per share) | $ 3.60 | |
Granted (in usd per share) | 5.22 | |
Exercised (in usd per share) | 0 | |
Forfeited (in usd per share) | 4.06 | |
Outstanding, Ending Balance (in usd per share) | 3.94 | $ 3.60 |
Exercisable, Ending Balance (in usd per share) | 3.38 | |
Vested and expected to vest (in usd per share) | $ 3.91 | |
Weighted average remaining contractual term (years) | ||
Outstanding, Beginning Balance (years) | 8 years 18 days | 8 years 7 months 20 days |
Exercisable, Balance Ending (years) | 7 years 7 months 6 days | |
Vested and expected to vest (years) | 8 years 1 month 13 days |
STOCK-BASED COMPENSATION - Assu
STOCK-BASED COMPENSATION - Assumptions Used to Estimate Fair Value of Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement [Abstract] | ||
Volatility | 90.39% | 83.78% |
Expected term in years | 5 years 11 months 23 days | 5 years 10 months 6 days |
Dividend rate | 0% | 0% |
Risk-free interest rate | 2% | 1.01% |
Fair value of option on grant date (in dollars per share) | $ 3.86 | $ 4 |
STOCK-BASED COMPENSATION - Rest
STOCK-BASED COMPENSATION - Restricted Stock Unit Activity (Details) - Restricted Stock Units (RSUs) | 12 Months Ended |
Dec. 31, 2022 shares | |
Shares | |
Beginning balance, outstanding (in shares) | 0 |
Granted (in shares) | 188,023 |
Vested and settled (in shares) | (9,406) |
Expired/forfeited/canceled (in shares) | (178,517) |
Ending balance, outstanding (in shares) | 0 |
INCOME TAX - Reconciliation of
INCOME TAX - Reconciliation of Federal Statutory Income Tax Rate to the Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Expected income tax benefit at the federal statutory rate | 21% | 21% |
State and local taxes, net of federal benefit | 10.80% | 10.60% |
Non-deductible items and other | (0.80%) | (0.50%) |
Change in valuation allowance | (31.00%) | (31.10%) |
Total | 0% | 0% |
INCOME TAX- Components of Defer
INCOME TAX- Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Federal and state net operating loss carryforwards | $ 8,346 | $ 6,617 |
Share based compensation | 342 | 308 |
Lease liabilities | 55 | 57 |
Research and development costs | 315 | 0 |
Accruals and other | 136 | 98 |
Gross deferred tax assets | 9,194 | 7,080 |
Less: deferred tax liabilities | 0 | (70) |
Less: valuation allowance | (9,194) | (7,010) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAX - Narrative (Details
INCOME TAX - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Contingency [Line Items] | ||
Valuation allowance, increase | $ (2,184) | |
Unrecognized tax benefits that would affect effective tax rate if recognized | 0 | $ 0 |
Federal | ||
Income Tax Contingency [Line Items] | ||
Operating loss carryforwards | 25,635 | |
State | ||
Income Tax Contingency [Line Items] | ||
Operating loss carryforwards | 25,925 | |
Local | ||
Income Tax Contingency [Line Items] | ||
Operating loss carryforwards | $ 18,560 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Jan. 11, 2021 | Feb. 28, 2021 | Jan. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |||||
Proceeds from convertible notes | $ 350 | $ 0 | $ 350 | ||
Salmon Pharma, Affiliate of Medice and David Baker, CEO | Convertible Promissory Note Purchase Agreement | |||||
Related Party Transaction [Line Items] | |||||
Proceeds from convertible notes | $ 350 | $ 350 | |||
Note interest rate | 7% | 7% | |||
Convertible notes, converted, shares issued (in shares) | 54,906 | 54,906 |