COVER PAGE
COVER PAGE - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 20, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36812 | ||
Entity Registrant Name | SALARIUS PHARMACEUTICALS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 46-5087339 | ||
Entity Address, Address Line One | 2450 Holcombe Blvd | ||
Entity Address, Address Line Two | Suite X | ||
Entity Address, City or Town | Houston | ||
Entity Address, State or Province | TX | ||
Entity Address, Postal Zip Code | 77021 | ||
City Area Code | 832 | ||
Local Phone Number | 834-6992 | ||
Title of 12(b) Security | Common Stock, par value $ 0.0001 | ||
Trading Symbol | SLRX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 11,654,060 | ||
Entity Common Stock, Shares Outstanding | 2,468,032 | ||
Entity Central Index Key | 0001615219 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement for its 2023 Annual Meeting of Stockholders, which will be filed with the United States Securities and Exchange Commission within 120 days of December 31, 2022, are incorporated by reference into Part III of this Annual Report on Form 10-K. |
AUDIT INFORMATION
AUDIT INFORMATION | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Firm ID | 42 |
Auditor Name | Ernst & Young LLP |
Auditor Location | Houston, Texas |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 12,106,435 | $ 29,214,380 |
Grants receivable from CPRIT | 1,610,490 | 0 |
Prepaid expenses and other current assets | 803,373 | 949,215 |
Total current assets | 14,520,298 | 30,163,595 |
Grants receivable from CPRIT | 0 | 1,610,490 |
Goodwill | 0 | 8,865,909 |
Other assets | 130,501 | 193,874 |
Total assets | 14,650,799 | 40,833,868 |
Current liabilities: | ||
Accounts payable | 2,858,330 | 1,543,096 |
Accrued expenses and other current liabilities | 1,407,861 | 567,787 |
Total liabilities | 4,266,191 | 2,110,883 |
Commitments and contingencies (NOTE 5) | ||
Stockholders' equity (deficit): | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; none issued or outstanding | 0 | 0 |
Common stock, $0.0001 par value; 100,000,000 shares authorized; 2,255,899 and 1,809,593 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 225 | 181 |
Additional paid-in capital | 74,189,531 | 70,919,996 |
Accumulated deficit | (63,805,148) | (32,197,192) |
Total stockholders' equity | 10,384,608 | 38,722,985 |
Total liabilities and stockholders' equity | $ 14,650,799 | $ 40,833,868 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 2,255,899 | 1,809,593 |
Common stock, shares outstanding | 2,255,899 | 1,809,593 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Revenue from contract with customer, product and service | Grant | Grant |
Grant revenue | $ 0 | $ 1,840,216 |
Operating expenses: | ||
Research and development | 15,836,828 | 8,548,520 |
General and administrative | 7,138,403 | 6,104,627 |
Loss on impairment of goodwill | 8,865,909 | 0 |
Total operating expenses | 31,841,140 | 14,653,147 |
Loss before other income (expense) | (31,841,140) | (12,812,931) |
Change in fair value of warrant liability | 14,454 | 44,693 |
Interest income | 218,730 | |
Net loss | (31,607,956) | (12,768,238) |
Loss attributable to common stockholders | $ (31,607,956) | $ (12,768,238) |
Loss per common share, basic (in dollars per share) | $ (14.88) | $ (7.72) |
Loss per common share, diluted (in dollars per share) | (14.88) | (7.72) |
Total net loss per share (in dollars per share) | $ (14.88) | $ (7.72) |
Weighted average number of shares outstanding, basic (in shares) | 2,124,511 | 1,654,638 |
Weighted average number of shares outstanding, diluted (in shares) | 2,124,511 | 1,654,638 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities | ||
Net loss | $ (31,607,956) | $ (12,768,238) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation, amortization and impairment | 6,677 | 19,183 |
Loss on impairment of goodwill | 8,865,909 | 0 |
Equity-based compensation expense | 796,803 | 559,044 |
Change in fair value of warrant liability | (14,454) | (44,693) |
In-process research and development technology | 1,987,900 | 0 |
Changes in operating assets and liabilities: | ||
Grants receivable | 0 | 2,245,506 |
Prepaid expenses and other current assets | 202,538 | (70,470) |
Accounts payable | 1,312,735 | (310,660) |
Accrued expenses and other current liabilities | 854,527 | 170,131 |
Net cash (used in) operating activities | (17,595,321) | (10,200,197) |
Investing activities | ||
Purchase in-process research and development technology | (1,500,000) | 0 |
Net cash used in investing activities | (1,500,000) | 0 |
Financing activities | ||
Proceeds from issuance of equity securities | 1,987,376 | 27,287,638 |
Proceeds from warrants exercised for cash | 0 | 1,485,353 |
Payments on note payable | 0 | (477,028) |
Net cash provided by financing activities | 1,987,376 | 28,295,963 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (17,107,945) | 18,095,766 |
Cash, cash equivalents and restricted cash at beginning of period | 29,214,380 | 11,118,614 |
Cash, cash equivalents and restricted cash at end of period | 12,106,435 | 29,214,380 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 0 | 1,468 |
Non-cash investing and financing activities: | ||
Common stock issued for in-process research and development technology | 487,900 | 0 |
Accrued cost for shares issued for cash | $ 2,500 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 952,341 | |||
Beginning balance at Dec. 31, 2020 | $ 22,159,188 | $ 95 | $ 41,588,047 | $ (19,428,954) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of equity securities, net (in shares) | 802,182 | |||
Issuance of equity securities, net | 27,287,638 | $ 81 | 27,287,557 | |
Warrants exercised for cash, net (in shares) | 51,943 | |||
Issuance of equity securities, net | $ 1,485,353 | $ 5 | 1,485,348 | |
Equity-based compensation and services expense (in shares) | 2,958 | |||
Equity-based compensation expense | $ 559,044 | 559,044 | ||
Issuance of equity securities for services (in shares) | 169 | |||
Net loss | (12,768,238) | (12,768,238) | ||
Ending balance (in shares) at Dec. 31, 2021 | 1,809,593 | |||
Ending balance at Dec. 31, 2021 | 38,722,985 | $ 181 | 70,919,996 | (32,197,192) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of equity securities, net (in shares) | 40,000 | |||
Issuance of equity securities, net | 487,900 | $ 4 | 487,896 | |
Warrants exercised for cash, net (in shares) | 373,577 | |||
Issuance of equity securities, net | $ 1,984,876 | $ 37 | 1,984,839 | |
Equity-based compensation and services expense (in shares) | 9,712 | 27,927 | ||
Equity-based compensation expense | $ 768,255 | $ 3 | 768,252 | |
Issuance of equity securities for services (in shares) | 4,802 | |||
Issuance of equity securities for services | 28,548 | 28,548 | ||
Net loss | (31,607,956) | (31,607,956) | ||
Ending balance (in shares) at Dec. 31, 2022 | 2,255,899 | |||
Ending balance at Dec. 31, 2022 | $ 10,384,608 | $ 225 | $ 74,189,531 | $ (63,805,148) |
ORGANIZATION AND OPERATIONS
ORGANIZATION AND OPERATIONS | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND OPERATIONS | ORGANIZATION AND OPERATIONS Nature of Business Salarius Pharmaceuticals, Inc. (“Salarius” or the “Company”), together with its subsidiaries, Salarius Pharmaceuticals, LLC, Flex Innovation Group LLC, and TK Pharma, Inc., is a clinical-stage biopharmaceutical company focused on developing effective treatments for cancers with high, unmet medical need. Specifically, the Company is developing treatments for cancers caused by dysregulated gene expression, i.e., genes that are incorrectly turned on or off. The Company is developing two classes of drugs that address gene dysregulation: targeted protein inhibitors and targeted protein degraders. The Company's technologies have the potential to work in both liquid and solid tumors. The Company's current pipeline consists of two small molecule drugs: 1) SP-3164, a targeted protein degrader, and 2) seclidemstat (SP-2577), a targeted protein inhibitor. The Company is located in Houston, Texas. In addition, the company has early stage development in both protein inhibition and protein degradation. Going Concern Salarius has no products approved for commercial sale, has not generated any revenue from product sales to date and has suffered recurring losses from operations since its inception. The lack of revenue from product sales to date and recurring losses from operations since its inception raise substantial doubt as to the Company's ability to continue as a going concern. The accompanying financial statements are prepared using accounting principles generally accepted in the United States applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities should the Company be unable to continue as a going concern. Salarius will require substantial additional capital to fund its research and development expenses related to its oncology drug. Based on Salarius’ expected cash requirements, Salarius believes that there is doubt that its existing cash and cash equivalents, will be sufficient to fund its operations through one year from the financial statements issuance date. The Company intends to obtain additional capital through the sale of equity securities in one or more offerings or through issuances of debt instruments, and may also consider new collaborations or selectively partnering its technology. However, the Company cannot provide any assurance that it will be successful in accomplishing any of its plans. Acquisition and Strategic Collaboration Agreement On January 12, 2022, the Company, entered into an Acquisition and Strategic Collaboration Agreement (the “ASCA”), with DeuteRx, LLC, a Delaware limited liability company (the “DeuteRx”), pursuant to which DeuteRx agreed to sell, and the Company agreed to purchase and assume from DeuteRx, all of DeuteRx’s rights, title, and interest in and to certain assets of DeuteRx, including SP-3164, DeuteRx’s intellectual property, information and data related to SP-3164, tangible materials or reagents related to SP-3164, goodwill, rights and claims, other than certain excluded assets (collectively, the “Purchased Assets”), all as more specifically set forth in the ASCA, and assume certain assumed liabilities, upon the terms and subject to the conditions set forth in the ASCA. The Aggregate purchase price paid under the ASCA was $2.0 million consisting of $1.5 million cash payment and the delivery of 40,000 shares of the Company's common stock, valued at $0.5 million. Total cost incurred in obtaining in-process research and development technology ("IPRD") that has no alternative future use are charged to research and development expense as acquired, and presented as investing activity cash outflow on the Statement of Cash Flow. In addition, the Company agreed to pay to DeuteRx potential future milestone payments upon the occurrence of an applicable Milestone Event (as defined in the ASCA) and potential future royalty payments. A member of the Company’s Board of Directors also serves as a consultant to DeuteRx and is employed by an affiliate of DeuteRx. |
BASIS OF PRESENTATION AND SIGNI
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States ("GAAP"). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standard Codification ("ASC") and Accounting Standards Update ("ASU") of the Financial Accounting Standards Board ("FASB"). The Company considered its going concern disclosure requirements in accordance with ASC 205-40-50.The Company has performed an analysis and concluded substantial doubt exists with respect to the Company being able to continue as a going concern through one year from the date of issuance of the consolidated financial statements for the year ended December 31, 2022. Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America as defined by the FASB ASC requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ from those estimates. Reclassification Certain reclassifications of prior period presentations have been made to conform to the current period presentation. Cash and Cash Equivalents Salarius considers all highly-liquid investments with original maturities of three months or less to be cash equivalents. Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that their carrying value may not be recoverable. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized in the amount by which the carrying amount of the asset exceeds the fair value of the asset. There were no impairment charges related to long-lived assets during the twelve months ended December 31, 2022 and 2021. Goodwill Goodwill is not amortized, but is tested at least annually for impairment at the reporting unit level. The Company has determined that the reporting unit is the single operating segment disclosed in its current financial statements. Additional impairment assessments may be performed on an interim basis if the Company encounters events or changes in circumstances that would indicate that, more likely than not, the carrying value of goodwill has been impaired. Impairment is the condition that exists when the carrying amount of goodwill exceeds its implied fair value. The Company utilizes the option to perform a qualitative assessment for its reporting unit and if the Company concludes it is more likely than not that the fair value of the reporting unit is less than its carrying amount, then the Company utilizes the two-step quantitative assessment. The Company’s qualitative assessment is sensitive to assumptions related to potential adverse events and circumstances, including current market trends in control premiums and involves judgement in determining comparable peer companies to include in the control premium evaluation. The Company recorded goodwill impairment loss of $8.9 million and $0 million during the twelve months ended December 31, 2022 and 2021, respectively . Financial Instruments and Credit Risks Financial instruments that potentially subject the Company to credit risk include cash and cash equivalents and restricted cash. Cash is deposited in demand accounts in federally insured domestic institutions to minimize risk. Insurance is provided through the Federal Deposit Insurance Corporation (“FDIC”). Although the balances in these accounts exceed the federally insured limit from time to time, the Company has not incurred losses related to these deposits. Warrants The Company determines whether warrants should be classified as a liability or equity. For warrants classified as liabilities, the Company estimates the fair value of the warrants at each reporting period using Level 3 inputs with changes in fair value recorded in the Consolidated Statement of Operations within change in fair value of warrant liability. The estimates in valuation models are based, in part, on subjective assumptions, including but not limited to stock price volatility, the expected life of the warrants, the risk-free interest rate and the fair value of the common stock underlying the warrants, and could differ materially in the future. The Company will continue to adjust the fair value of the warrant liability at the end of each reporting period for changes in fair value from the prior period until the earlier of the exercise or expiration of the applicable warrant. For warrants classified as equity contracts, the Company allocates the transaction proceeds to the warrants and any other free-standing instruments issued in the transaction based on an allowable allocation method. Clinical Trial Accruals The Company’s preclinical and clinical trials are performed by third party contract research organizations (CROs) and/or clinical investigators, and clinical supplies are manufactured by contract manufacturing organizations (CMOs). Invoicing from these third parties may be monthly based upon services performed or based upon milestones achieved. The Company accrues these expenses based upon its assessment of the status of each clinical trial and the work completed, and upon information obtained from the CROs and CMOs. The Company’s estimates are dependent upon the timeliness and accuracy of data provided by the CROs and CMOs regarding the status and cost of the studies, and may not match the actual services performed by the organizations. This could result in adjustments to the Company’s research and development expenses in future periods. To date the Company has had no significant adjustments. Grants Receivable and Revenue Recognition Salarius’ source of revenue has been from a grant received from CPRIT. Grant revenue is recognized when qualifying costs are incurred and there is reasonable assurance that conditions of the grant have been met. Cash received from grants in advance of incurring qualifying costs is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred. The Company records revenue and a corresponding grants receivable when qualifying costs are incurred before the grants are received. Research and Development Costs Research and development costs consist of expenses incurred in performing research and development activities, including pre-clinical studies and clinical trials. Research and development costs include salaries and personnel-related costs, consulting fees, fees paid for contract research services, the costs of laboratory equipment and facilities, license fees and other external costs. Research and development costs are expensed when incurred. Costs incurred in obtaining IPRD that has no alternative future use are charged to research and development expense as acquired, and presented as investing activity cash outflows on the Statement of Cash Flow. Equity-Based Compensation Salarius measures equity-based compensation based on the grant date fair value of the awards and recognizes the associated expense in the financial statements over the requisite service period of the award, which is generally the vesting period. The Company uses the Black-Scholes option valuation model to estimate the fair value of the stock-based compensation and incentive units. Assumptions utilized in these models include expected volatility calculated based on implied volatility from traded stocks of peer companies, dividend yield and risk-free interest rate. Additionally, forfeitures are accounted for in compensation cost as they occur. Loss Per Share Basic net loss per share is calculated by dividing the net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods, as the inclusion of all potential common shares outstanding is anti-dilutive. The number of anti-dilutive shares, consisting of common shares underlying (i) common stock options, (ii) stock purchase warrants, (iii) unvested restricted stock and (iv) rights entitling holders to receive warrants to purchase the Company's common shares, which have been excluded from the computation of diluted loss per share, was 704,640 and 381,248 shares as of December 31, 2022 and 2021, respectively. Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. The Company has evaluated available evidence and concluded that the Company may not realize the benefit of its deferred tax assets; therefore, a valuation allowance has been established for the full amount of the deferred tax assets. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2022 and 2021, the Company did not have any significant uncertain tax positions and no interest or penalties have been charged. The Company's practice is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company is subject to routine audits by taxing jurisdictions. Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which requires the measurement of all expected credit losses for financial assets including trade receivables held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Subsequent to the issuance of ASU 2016-13, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments - Credit Losses . This ASU does not change the core principle of the guidance in ASU 2016-13, instead these amendments are intended to clarify and improve operability of certain topics included within the credit losses guidance. The FASB also subsequently issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Derivatives and Hedging (Topic 815), and Financial Instruments (Topic 842) , which did not change the core principle of the guidance in ASU 2016-13 but clarified that expected recoveries of amounts previously written off and expected to be written off should be included in the valuation account and should not exceed amounts previously written off and expected to be written off. The guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019 for public business entities, excluding smaller reporting companies. Early adoption is permitted. As a smaller reporting company, the guidance will be effective for the Company during the first quarter of 2023. The Company is in the process of assessing the impact adoption will have on its consolidated financial statements. |
GRANTS RECEIVABLE
GRANTS RECEIVABLE | 12 Months Ended |
Dec. 31, 2022 | |
Receivables [Abstract] | |
GRANTS RECEIVABLE | GRANTS RECEIVABLEGrants receivable represents qualifying costs incurred where there is reasonable assurance that conditions of the grant have been met but the corresponding funds have not been received as of the reporting date. Grants receivable balances were $1.6 million as of December 31, 2022 and December 31, 2021, respectively. Grant receivables are classified as current or non-current receivables based on the Company’s best estimate of whether or not the amounts will be collected within one year of the balance sheet date. The Company received $1.5 million from the Cancer Prevention and Research Institute of Texas on February 15, 2023. |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets at December 31, 2022 and 2021 consisted of the following: December 31, 2022 2021 Prepaid clinical trial expenses $ 11,185 $ 97,557 Prepaid insurance 624,612 678,672 Other prepaid and current assets 167,576 172,986 Total prepaid expenses and other current assets $ 803,373 $ 949,215 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES License Agreement with the University of Utah Research Foundation In 2011, the Company entered into a license agreement with the University of Utah, under which, the Company acquired license to LSD 1. In exchange for the license, the Company issued 2% equity ownership in the Company based on a fully diluted basis at the effective date of the agreement and subject to certain adjustments specified in the agreement, granted revenue sharing rights on any resulting products or processes to commence on first commercial sale, and milestone payments based upon regulatory approval of any resulting product or process as well as on the second anniversary of first commercial sale. Cancer Prevention and Research Institute of Texas In June 2016, the Company entered into a Cancer Research Grant Contract with CPRIT. Pursuant to the contract, CPRIT awarded the Company a grant up to $18.7 million, further modified to $16.1 million to fund development of LSD 1 inhibitor. This is a 3-year grant award originally expired on May 31, 2019. The grant now expires on May 31, 2023. The Company applied for a no cost extension through November 30, 2023. The Company will retain ownership over any intellectual property developed under the contract ("Project Result"). With respect to non-commercial use of any Project Result, the Company agreed to grant to CPRIT a nonexclusive, irrevocable, royalty-free, perpetual, worldwide license with right to sublicense any necessary additional intellectual property rights to exploit all Project Results by CPRIT, other governmental entities and agencies of the State of Texas, and private or independent institutions of higher education located in Texas, for education, research and other non-commercial purposes. The Company is obligated to make revenue-sharing payments to CPRIT with respect to net sales of any product covered by the contract, up to a maximum repayment of certain percentage of the aggregate amount paid to the Company by CPRIT under the CPRIT contract. The payments are determined as a percentage of net sales, which may be reduced if the Company is required to obtain a license from a third party to sell any such product. In addition, upon meeting the foregoing limitation on revenue-sharing payments, the Company agreed to make continued revenue-sharing payments to CPRIT of less than 1% of net sales. Lease Agreement |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | FAIR VALUE OF FINANCIAL INSTRUMENTS Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. A fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last is considered unobservable, are used to measure fair value: Level 1-Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2-Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3-Significant unobservable inputs including Salarius’ own assumptions in determining fair value. The Company believes the recorded values of its financial instruments, including cash and cash equivalents, accounts payable and note payable approximate their fair values due to the short-term nature of these instruments. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS' EQUITY | STOCKHOLDERS' EQUITY Preferred Stock and Common Stock On October 14, 2022, the Company filed a Certificate of Amendment to the Company’s restated certificate of incorporation with the Secretary of State of the State of Delaware to effect a 1-for-25 reverse stock split of the Company’s issued and outstanding shares of common stock, par value $0.0001 per share (the “Reverse Stock Split”), which became effective on October 14, 2022. All historical share and per share amounts reflected throughout this report have been adjusted to reflect the Reverse Stock Split. Common Stock Issuances On January 12, 2022, the Company issued 40,000 shares of the Company's common stock, valued at $0.5 million to purchase in-process research and development technology SP-3164, please refer to NOTE 1 for further discussion. On April 22, 2022, the Company entered into a securities purchase agreement with certain institutional and accredited investors for the sale by the Company of approximately 373,577 shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”) at a purchase price of $6.25 per share. Concurrently, the Company also sold unregistered warrants exercisable for an aggregate of approximately 280,183 shares of Common Stock, which represents 75% of the shares of Common Stock sold, with an exercise price of $ 8.4975 per share. The transaction closed on April 26, 2022 with gross proceeds of $2.3 million before deducting certain fees due to the placement agent and other estimated transaction expenses. On February 5, 2021, the Company entered into an At the Market Offering Agreement ("ATM") with Ladenburg Thalmann & Co. Inc. Under this agreement the Company is able to issue and sell, from time to time, shares of its common stock. On February 5, 2021 and July 2, 2021, the Company filed prospectus supplements with the SEC to register the offering and sale of Common Stock having an aggregate offering price of up to $6.3 million and $25.0 million, respectively. During the twelve months ended December 31, 2021, the Company issued 3,247,834 shares under the ATM for gross proceeds of $6.8 million. On March 8, 2021, the Company completed a public offering of 672,269 shares of its common stock at a price to the public of $34.21 per share. Total gross proceeds from the offering were approximately $23.0 million prior to deducting underwriting discounts and commissions and offering expenses payable by the Company. Warrants Exercised for Cash The Company has five-year warrants outstanding that were issued in February 2020 and subsequently modified in December 2020 in connection with the issuance of additional inducement warrants. The warrants are exercisable at a price per share of $28.75. The inducement warrants expire on June 11, 2026 and are exercisable at a price per share of $29.55. The Company has 5.5 year warrants issued on April 2022, with an exercise price of $8.4975 per share. The warrants will be exercisable six months following the issuance date and will expire five and one-half years from the issuance date. During the twelve months ended December 31, 2022, no warrants were exercised. During the twelve months ended December 31, 2021, the Company issued approximately 51,943 common shares as a result of warrant exercises, and received cash proceeds of approximately $1.5 million, respectively. |
EQUITY-BASED COMPENSATION
EQUITY-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
EQUITY-BASED COMPENSATION | EQUITY-BASED COMPENSATION Equity Incentive Plans The Company has granted options to employees, directors, and consultants under the 2015 Equity Incentive Plan (the "2015 Plan"). The 2015 Plan provides for the grant of incentive stock options ("ISOs"), nonstatutory stock options, restricted stock awards, restricted stock units, stock appreciation rights, performance-based stock awards and other stock-based awards. Additionally, the 2015 Plan provides for the grant of performance-based cash awards. ISOs may be granted only to the Company's employees. All other awards may be granted to the Company's employees, including officers, and to non-employee directors and consultants. As of December 31, 2022 and 2021, there were 47,228 and 41,068 shares, respectively, remaining available for the grant of stock option under the 2015 Plan. During the twelve months ended December 31, 2022 and 2021, the Company awarded 51,360 and 3,160, respectively, stock options to its employees and directors, pursuant to the plan described above. Stock options generally vest over one The fair value of the option grants of $0.5 million and $0.1 million respectively, has been estimated with the following assumptions for the year ended December 31, 2022 and 2021: 2022 2021 Risk-free interest rate 1.62%-1.70% 0.93%-1.09% Volatility 125.19% - 126.42% 130.44%-133.35% Expected life (years) 5 -6 years 6 years Expected dividend yield 0.00% 0.00% The following table summarizes stock option activity for employees and non-employees for the twelve months ended December 31, 2022 and 2021: Shares Weighted-Average Weighted-Average Aggregate Outstanding at December 31, 2020 62,559 $ 69.50 4.87 $ 175,770 Granted 3,160 32.50 Exercised — — Forfeited (1,800) — Expired — — Outstanding at December 31, 2021 63,919 $ 68.75 8.50 $ — Exercisable at December 31, 2021 27,334 $ 121.25 8.21 $ — Granted 51,360 $ 10.95 Exercised — Forfeited (6,776) Expired (1,375) Outstanding at December 31, 2022 107,128 $ 23.67 8.29 $ — Exercisable at December 31, 2022 38,100 $ 35.85 7.63 $ — As of December 31, 2022 and 2021, there was approximately $0.8 million and $0.9 million of total unrecognized compensation cost, respectively, related to unvested stock options. Total unrecognized compensation cost will be adjusted for future changes in employee and non-employee forfeitures, if any. The Company expects to recognize that cost over a remaining weighted-average period of 2.13 years. During the year ended December 31, 2021, the Company granted 3,160 stock options, in the aggregate, to certain employees. These awards vest monthly over 4 years as continuous services are provided, and expense is being recognized over this period. Total compensation cost related to stock options was $0.5 million for the year ended December 31, 2021. During the year ended December 31, 2022, the Company granted 51,360 stock options, in the aggregate, to certain employees and directors. These awards vest over 1 year to 4 years as continuous services are provided, and expense is being recognized over this period. Total compensation cost related to stock options was $0.5 million for the year ended December 31, 2022 During the year ended December 31, 2022 and 2021, the Company granted 9,712 and 2,958 shares of common stock to its Employee Stock Purchase Plan ("ESPP") participants. Fair value of the grants are valued using the Black-Scholes option pricing model and compensation cost is recognized based on the resulting value over the derived service period. |
INCOME TAX
INCOME TAX | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
INCOME TAX | INCOME TAXThe Company has no current or deferred tax expense due to its current year loss and its overall net operating loss position. A reconciliation of the federal statutory tax rate and the effective tax rates for the year ended December 31, 2022 and 2021 is as follows: December 31 2022 2021 Federal Tax at Statutory Rate 21.00% 21.00% Permanent (6.25)% (0.69)% Change in Valuation Allowance (21.73)% (26.13)% True Ups (0.06)% —% R&D Credit 7.04% 5.82% Effective Tax Rate —% —% The tax effects of temporary differences that give rise to significant portions of the deferred tax assets were as follows: December 31 2022 2021 Capitalized R&D Expenses $ 5,199,721 $ 3,002,819 Other Deferred Items 145,935 121,152 Stock Compensation 484,205 50,650 Net Operating Loss - US 3,919,323 1,931,959 R&D Credits 3,293,572 1,068,451 Net deferred tax assets 13,042,756 6,175,031 Valuation Allowance (13,042,756) (6,175,031) Net deferred tax assets (liabilities) $ — $ — The valuation allowance recorded by the Company as of December 31, 2022 and December 31, 2021 resulted from the uncertainties of the future utilization of deferred tax assets relating from NOL carry forwards for federal and state income tax purposes. Realization of the NOL carry forwards is contingent on future taxable earnings. The deferred tax asset was reviewed for expected utilization using a “more likely than not” approach by assessing the available positive and negative evidence surrounding its recoverability. Accordingly, a full valuation allowance continues to be recorded against the Company’s deferred tax asset, as it was determined based upon past and projected future losses that it was “more likely than not” that the Company’s deferred tax assets would not be realized. In future years, if the deferred tax assets are determined by management to be “more likely than not” to be realized, the recognized tax benefits relating to the reversal of the valuation allowance will be recorded. The Company will continue to assess and evaluate strategies that will enable the deferred tax asset, or portion thereof, to be utilized, and will reduce the valuation allowance appropriately as such time when it is determined that the “more likely than not” criteria is satisfied. The federal net operating loss carryforwards of $18.6 million have an indefinite life, but the R&D credits of $3.2 million begin to expire in 2039. Due to the change in ownership provisions of the Internal Revenue Code, the availability of the Company’s net operating loss carry forwards could be subject to annual limitations against taxable income in future periods, which could substantially limit the eventual utilization of such carry forwards. The Company has not analyzed the historical or potential impact of its equity financings on beneficial ownership and therefore no determination has been made whether the net operating loss carry forward is subject to any Internal Revenue Code Section 382 limitation. To the extent there is a limitation, there could be a reduction in the deferred tax asset with an offsetting reduction in the valuation allowance. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as an interest and penalties expense in the current year. There were no uncertain tax positions that require accrual or disclosure to the financial statements as of December 31, 2022. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS On February 15, 2023, the Company received $1.5 million from the Cancer Prevention and Research Institute of Texas. The payment is part of a non-dilutive grant of approximately $16.1 million awarded to support operations and development of the Company's drug candidate seclidemstat for the treatment of Ewing sarcoma. The $1.5 million payment brings the Company's cumulative disbursement from CPRIT to approximately $16.0 million. From January 27, 2023 through March 24, 2023, the Company sold 142,499 shares of its common shares with gross proceeds of approximately $0.4 million pursuant to its at the-market equity offering program. |
BASIS OF PRESENTATION AND SIG_2
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States ("GAAP"). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standard Codification ("ASC") and Accounting Standards Update ("ASU") of the Financial Accounting Standards Board ("FASB"). The Company considered its going concern disclosure requirements in accordance with ASC 205-40-50.The Company has performed an analysis and concluded substantial doubt exists with respect to the Company being able to continue as a going concern through one year from the date of issuance of the consolidated financial statements for the year ended December 31, 2022. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America as defined by the FASB ASC requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ from those estimates. |
Reclassification | ReclassificationCertain reclassifications of prior period presentations have been made to conform to the current period presentation. |
Cash and Cash Equivalents | Cash and Cash Equivalents Salarius considers all highly-liquid investments with original maturities of three months or less to be cash equivalents. |
Impairment of Long-Lived Assets | Impairment of Long-Lived AssetsLong-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that their carrying value may not be recoverable. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized in the amount by which the carrying amount of the asset exceeds the fair value of the asset. |
Goodwill | Goodwill Goodwill is not amortized, but is tested at least annually for impairment at the reporting unit level. The Company has determined that the reporting unit is the single operating segment disclosed in its current financial statements. Additional impairment assessments may be performed on an interim basis if the Company encounters events or changes in circumstances that would indicate that, more likely than not, the carrying value of goodwill has been impaired. |
Financial Instruments and Credit Risks | Financial Instruments and Credit Risks Financial instruments that potentially subject the Company to credit risk include cash and cash equivalents and restricted cash. Cash is deposited in demand accounts in federally insured domestic institutions to minimize risk. Insurance is provided through the Federal Deposit Insurance Corporation (“FDIC”). Although the balances in these |
Warrants | Warrants The Company determines whether warrants should be classified as a liability or equity. For warrants classified as liabilities, the Company estimates the fair value of the warrants at each reporting period using Level 3 inputs with changes in fair value recorded in the Consolidated Statement of Operations within change in fair value of warrant liability. The estimates in valuation models are based, in part, on subjective assumptions, including but not limited to stock price volatility, the expected life of the warrants, the risk-free interest rate and the fair value of the common stock underlying the warrants, and could differ materially in the future. The Company will continue to adjust the fair value of the warrant liability at the end of each reporting period for changes in fair value from the prior period until the earlier of the exercise or expiration of the applicable warrant. For warrants classified as equity contracts, the Company allocates the transaction proceeds to the warrants and any other free-standing instruments issued in the transaction based on an allowable allocation method. |
Grants Receivable and Revenue Recognition | Grants Receivable and Revenue RecognitionSalarius’ source of revenue has been from a grant received from CPRIT. Grant revenue is recognized when qualifying costs are incurred and there is reasonable assurance that conditions of the grant have been met. Cash received from grants in advance of incurring qualifying costs is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred. The Company records revenue and a corresponding grants receivable when qualifying costs are incurred before the grants are received. |
Research and Development Costs | Research and Development Costs Research and development costs consist of expenses incurred in performing research and development activities, including pre-clinical studies and clinical trials. Research and development costs include salaries and personnel-related costs, consulting fees, fees paid for contract research services, the costs of laboratory equipment and facilities, license fees and other external costs. Research and development costs are expensed when incurred. Costs incurred in obtaining IPRD that has no alternative future use are charged to research and development expense as acquired, and presented as investing activity cash outflows on the Statement of Cash Flow. |
Equity-Based Compensation | Equity-Based Compensation Salarius measures equity-based compensation based on the grant date fair value of the awards and recognizes the associated expense in the financial statements over the requisite service period of the award, which is generally the vesting period. |
Loss Per Share | Loss Per ShareBasic net loss per share is calculated by dividing the net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods, as the inclusion of all potential common shares outstanding is anti-dilutive. |
Income Taxes | Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. The Company has evaluated available evidence and concluded that the Company may not realize the benefit of its deferred tax assets; therefore, a valuation allowance has been established for the full amount of the deferred tax assets. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2022 and 2021, the Company did not have any significant uncertain tax positions and no interest or penalties have been charged. The Company's practice is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company is subject to routine audits by taxing jurisdictions. |
Application of New Accounting Standards and Pronouncements Not Yet Adopted | Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which requires the measurement of all expected credit losses for financial assets including trade receivables held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Subsequent to the issuance of ASU 2016-13, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments - Credit Losses . This ASU does not change the core principle of the guidance in ASU 2016-13, instead these amendments are intended to clarify and improve operability of certain topics included within the credit losses guidance. The FASB also subsequently issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Derivatives and Hedging (Topic 815), and Financial Instruments (Topic 842) , which did not change the core principle of the guidance in ASU 2016-13 but clarified that expected recoveries of amounts previously written off and expected to be written off should be included in the valuation account and should not exceed amounts previously written off and expected to be written off. The guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019 for public business entities, excluding smaller reporting companies. Early adoption is permitted. As a smaller reporting company, the guidance will be effective for the Company during the first quarter of 2023. The Company is in the process of assessing the impact adoption will have on its consolidated financial statements. |
Fair Value of Financial Instruments | Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. A fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last is considered unobservable, are used to measure fair value: Level 1-Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2-Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3-Significant unobservable inputs including Salarius’ own assumptions in determining fair value. |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets at December 31, 2022 and 2021 consisted of the following: December 31, 2022 2021 Prepaid clinical trial expenses $ 11,185 $ 97,557 Prepaid insurance 624,612 678,672 Other prepaid and current assets 167,576 172,986 Total prepaid expenses and other current assets $ 803,373 $ 949,215 |
EQUITY-BASED COMPENSATION (Tabl
EQUITY-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Fair Value Assumptions | 2022 2021 Risk-free interest rate 1.62%-1.70% 0.93%-1.09% Volatility 125.19% - 126.42% 130.44%-133.35% Expected life (years) 5 -6 years 6 years Expected dividend yield 0.00% 0.00% |
Summary of Stock Option Activity | The following table summarizes stock option activity for employees and non-employees for the twelve months ended December 31, 2022 and 2021: Shares Weighted-Average Weighted-Average Aggregate Outstanding at December 31, 2020 62,559 $ 69.50 4.87 $ 175,770 Granted 3,160 32.50 Exercised — — Forfeited (1,800) — Expired — — Outstanding at December 31, 2021 63,919 $ 68.75 8.50 $ — Exercisable at December 31, 2021 27,334 $ 121.25 8.21 $ — Granted 51,360 $ 10.95 Exercised — Forfeited (6,776) Expired (1,375) Outstanding at December 31, 2022 107,128 $ 23.67 8.29 $ — Exercisable at December 31, 2022 38,100 $ 35.85 7.63 $ — |
INCOME TAX (Tables)
INCOME TAX (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the federal statutory tax rate and the effective tax rates for the year ended December 31, 2022 and 2021 is as follows: December 31 2022 2021 Federal Tax at Statutory Rate 21.00% 21.00% Permanent (6.25)% (0.69)% Change in Valuation Allowance (21.73)% (26.13)% True Ups (0.06)% —% R&D Credit 7.04% 5.82% Effective Tax Rate —% —% |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that give rise to significant portions of the deferred tax assets were as follows: December 31 2022 2021 Capitalized R&D Expenses $ 5,199,721 $ 3,002,819 Other Deferred Items 145,935 121,152 Stock Compensation 484,205 50,650 Net Operating Loss - US 3,919,323 1,931,959 R&D Credits 3,293,572 1,068,451 Net deferred tax assets 13,042,756 6,175,031 Valuation Allowance (13,042,756) (6,175,031) Net deferred tax assets (liabilities) $ — $ — |
ORGANIZATION AND OPERATIONS (De
ORGANIZATION AND OPERATIONS (Details) - USD ($) | 12 Months Ended | |||
Jan. 12, 2022 | Mar. 08, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Proceeds from issuance of equity securities | $ 1,987,376 | $ 27,287,638 | ||
Purchase in-process research and development technology | (1,500,000) | 0 | ||
Issuance of equity securities, net | $ 23,000,000 | $ 487,900 | $ 27,287,638 | |
Common Stock | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Issuance of equity securities, net (in shares) | 40,000 | 672,269 | 40,000 | 802,182 |
Issuance of equity securities, net | $ 4 | $ 81 |
BASIS OF PRESENTATION AND SIG_3
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Accounting Policies [Abstract] | ||
Impairment charges of long-lived assets | $ 0 | $ 0 |
Loss on impairment of goodwill | $ 8,865,909 | $ 0 |
Antidilutive securities excluded from computation of earnings per share (shares) | 704,640 | 381,248 |
GRANTS RECEIVABLE (Details)
GRANTS RECEIVABLE (Details) - USD ($) | 1 Months Ended | ||||
Feb. 15, 2023 | Jul. 01, 2016 | Jun. 30, 2016 | Dec. 31, 2022 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | |||||
Grants receivable from CPRIT | $ 1,610,490 | $ 0 | |||
Award amount | $ 16,100,000 | $ 18,700,000 | |||
Grant | |||||
Subsequent Event [Line Items] | |||||
Grants receivable from CPRIT | $ 1,600,000 | $ 1,600,000 | |||
Subsequent event | |||||
Subsequent Event [Line Items] | |||||
Award amount | $ 16,100,000 | ||||
Subsequent event | Grant | |||||
Subsequent Event [Line Items] | |||||
Award amount | $ 1,500,000 |
PREPAID EXPENSES AND OTHER CU_3
PREPAID EXPENSES AND OTHER CURRENT ASSETS - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid clinical trial expenses | $ 11,185 | $ 97,557 |
Prepaid insurance | 624,612 | 678,672 |
Other prepaid and current assets | 167,576 | 172,986 |
Total prepaid expenses and other current assets | $ 803,373 | $ 949,215 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) - USD ($) $ in Millions | 1 Months Ended | |||
Jul. 01, 2016 | Jun. 30, 2016 | Dec. 31, 2022 | Dec. 31, 2011 | |
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | ||||
Award amount | $ 16.1 | $ 18.7 | ||
Award term | 3 years | |||
Continued payments, percent of net sales | 1% | |||
University of Utah Research Foundation | ||||
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | ||||
Ownership percentage by noncontrolling Owner | 2% |
STOCKHOLDERS' EQUITY - Narrativ
STOCKHOLDERS' EQUITY - Narrative (Details) | 12 Months Ended | ||||||||||
Oct. 14, 2022 | Apr. 26, 2022 USD ($) | Apr. 22, 2022 $ / shares shares | Jan. 12, 2022 shares | Jul. 02, 2021 shares | Mar. 08, 2021 USD ($) $ / shares shares | Feb. 05, 2021 shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Apr. 30, 2022 $ / shares | Dec. 31, 2020 $ / shares | |
Class of Stock [Line Items] | |||||||||||
Conversion ratio | 0.04 | ||||||||||
Preferred stock, par value (usd per share) | $ 0.0001 | $ 0.0001 | |||||||||
Issuance of equity securities, net | $ | $ 23,000,000 | $ 487,900 | $ 27,287,638 | ||||||||
Exercise price (in dollar per share) | $ 29.55 | ||||||||||
Warrants term | 5 years 6 months | 5 years | |||||||||
Warrants and rights exercisable, term | 6 months | ||||||||||
Proceeds from warrants exercised for cash | $ | $ 0 | $ 1,485,353 | |||||||||
Class of warrant or right, outstanding | shares | 597,512 | 317,329 | |||||||||
Maximum | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price (in dollar per share) | $ 28.75 | ||||||||||
Purchase Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Proceeds | $ | $ 2,300,000 | ||||||||||
At the Market Offering Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Issuance of equity securities, net (in shares) | shares | 25,000,000 | 6,300,000 | 3,247,834 | ||||||||
Issuance of equity securities, net | $ | $ 6,800,000 | ||||||||||
Common Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock, par value (usd per share) | $ 0.0001 | ||||||||||
Issuance of equity securities, net (in shares) | shares | 40,000 | 672,269 | 40,000 | 802,182 | |||||||
Issuance of equity securities, net | $ | $ 4 | $ 81 | |||||||||
Warrants exercised for cash, net (in shares) | shares | 373,577 | 373,577 | 51,943 | ||||||||
Price per share (in dollar per share) | $ 34.21 | ||||||||||
Common Stock | Purchase Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Price per share (in dollar per share) | $ 6.25 | ||||||||||
Warrant | Purchase Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Number of shares issued (in shares) | shares | 280,183 | ||||||||||
Sale of stock, percentage of share In transaction | 75% | ||||||||||
Exercise price (in dollar per share) | $ 8.4975 | $ 8.4975 |
EQUITY-BASED COMPENSATION - Nar
EQUITY-BASED COMPENSATION - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of stock options granted (shares) | 51,360 | 3,160 |
Fair value | $ 0.5 | $ 0.1 |
Unrecognized compensation cost, options | $ 0.8 | $ 0.9 |
Equity-based compensation and services expense (in shares) | 9,712 | 2,958 |
Share-based Payment Arrangement, Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | |
Stock options, contractual term | 10 years | |
Unrecognized compensation cost, recognition period | 2 years 1 month 17 days | |
Equity-based compensation expense | $ 0.5 | $ 0.5 |
Share-based Payment Arrangement, Option | Certain Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 6 months | |
Maximum | Share-based Payment Arrangement, Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | |
Maximum | Share-based Payment Arrangement, Option | Certain Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | |
Minimum | Share-based Payment Arrangement, Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 1 year | |
Minimum | Share-based Payment Arrangement, Option | Certain Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation arrangement by share-based payment award, award vesting period | 1 year | |
2015 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares remaining available for grant of stock awards (shares) | 47,228 | 41,068 |
EQUITY-BASED COMPENSATION - Sch
EQUITY-BASED COMPENSATION - Schedule of Fair Value Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 1.62% | 0.93% |
Risk-free interest rate, maximum | 1.70% | 1.09% |
Volatility, minimum | 125.19% | 130.44% |
Volatility, maximum | 126.42% | 133.35% |
Expected life (years) | 6 years | |
Expected dividend yield | 0% | 0% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (years) | 5 years | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected life (years) | 6 years |
EQUITY-BASED COMPENSATION - Sum
EQUITY-BASED COMPENSATION - Summary of Stock Option Activity (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Shares | |||
Outstanding, beginning balance (shares) | 63,919 | 62,559 | |
Granted (shares) | 51,360 | 3,160 | |
Exercised (shares) | 0 | 0 | |
Forfeited (shares) | (6,776) | (1,800) | |
Expired (shares) | (1,375) | 0 | |
Outstanding, ending balance (shares) | 107,128 | 63,919 | 62,559 |
Exercisable (shares) | 38,100 | 27,334 | |
Weighted-Average Exercise Price | |||
Beginning balance (in usd per share) | $ 68.75 | $ 69.50 | |
Granted (in usd per share) | 10.95 | 32.50 | |
Exercised (in usd per share) | 0 | ||
Forfeited (in usd per share) | 0 | ||
Expired (in usd per share) | 0 | ||
Ending balance (in usd per share) | 23.67 | 68.75 | $ 69.50 |
Exercisable (in usd per share) | $ 35.85 | $ 121.25 | |
Weighted-Average Remaining Contractual Term (in years) and Aggregate Intrinsic Value | |||
Outstanding, weighted-average remaining contractual term | 8 years 3 months 14 days | 8 years 6 months | 4 years 10 months 13 days |
Exercisable, weighted-average remaining contractual term | 7 years 7 months 17 days | 8 years 2 months 15 days | |
Outstanding, aggregate intrinsic value | $ 0 | $ 0 | $ 175,770 |
Exercisable, aggregate intrinsic value | $ 0 | $ 0 |
INCOME TAX - Schedule of Effect
INCOME TAX - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Amount | ||
Federal Tax at Statutory Rate | 21% | 21% |
Permanent | (6.25%) | (0.69%) |
Change in Valuation Allowance | (21.73%) | (26.13%) |
True Ups | (0.06%) | 0% |
R&D Credit | 7.04% | 5.82% |
Effective Tax Rate | 0% | 0% |
INCOME TAX - Schedule of Deferr
INCOME TAX - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | ||
Capitalized R&D Expenses | $ 5,199,721 | $ 3,002,819 |
Other Deferred Items | 145,935 | 121,152 |
Stock Compensation | 484,205 | 50,650 |
Net Operating Loss - US | 3,919,323 | 1,931,959 |
R&D Credits | 3,293,572 | 1,068,451 |
Net deferred tax assets | 13,042,756 | 6,175,031 |
Valuation Allowance | (13,042,756) | (6,175,031) |
Net deferred tax assets (liabilities) | $ 0 | $ 0 |
INCOME TAX - Narrative (Details
INCOME TAX - Narrative (Details) $ in Millions | 12 Months Ended | 48 Months Ended |
Dec. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Operating Loss Carryforwards [Line Items] | ||
Capitalization of research and development costs | $ 13.4 | $ 24.7 |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 18.6 | 18.6 |
Federal | Research and development tax credit | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforward | $ 3.2 | $ 3.2 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) $ in Millions | 1 Months Ended | |||
Feb. 15, 2023 | Jul. 01, 2016 | Mar. 24, 2023 | Jun. 30, 2016 | |
Subsequent Event [Line Items] | ||||
Award amount | $ 16.1 | $ 18.7 | ||
Subsequent event | ||||
Subsequent Event [Line Items] | ||||
Award amount | $ 16.1 | |||
Revenue from cumulative disbursement | 16 | |||
Subsequent event | At The Market Equity Offering Program | ||||
Subsequent Event [Line Items] | ||||
Number of shares issued (in shares) | 142,499 | |||
Proceeds | $ 0.4 | |||
Subsequent event | Grant | ||||
Subsequent Event [Line Items] | ||||
Award amount | $ 1.5 |