Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | May 14, 2024 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-38302 | |
Entity Registrant Name | NRX Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 82-2844431 | |
Entity Address, Address Line One | 1201 Orange Street | |
Entity Address, Address Line Two | Suite 600 | |
Entity Address, City or Town | Wilmington | |
Entity Address, State or Province | DE | |
Entity Address, Postal Zip Code | 19801 | |
City Area Code | 484 | |
Local Phone Number | 254-6134 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 10,700,609 | |
Entity Central Index Key | 0001719406 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Common Stock | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | NRXP | |
Security Exchange Name | NASDAQ | |
Common stock warrants | ||
Title of 12(b) Security | Warrants to purchase Common Stock | |
Trading Symbol | NRXPW | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 1,319 | $ 4,595 |
Prepaid expense and other current assets | 2,028 | 2,289 |
Total current assets | 3,347 | 6,884 |
Other assets | 441 | 431 |
Total assets | 3,788 | 7,315 |
Current liabilities: | ||
Accounts payable | 6,265 | 4,632 |
Accrued and other current liabilities | 5,296 | 4,714 |
Accrued clinical site costs | 491 | 524 |
Convertible note payable and accrued interest | 6,779 | 9,161 |
Warrant liabilities | 26 | 17 |
Total liabilities | 18,857 | 19,048 |
Commitments and Contingencies (Note 8) | ||
Stockholders' deficit: | ||
Preferred stock, value | ||
Common stock, $0.001 par value, 500,000,000 shares authorized; 9,772,672 and 8,391,940 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 10 | 8 |
Additional paid-in capital | 244,599 | 241,406 |
Accumulated other comprehensive loss | (3) | (3) |
Accumulated deficit | (259,675) | (253,147) |
Total stockholders' deficit | (15,069) | (11,733) |
Total liabilities and stockholders' deficit | $ 3,788 | 7,315 |
Series A Convertible Preferred Stock | ||
Stockholders' deficit: | ||
Preferred stock, value | $ 3 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Apr. 01, 2024 | Mar. 31, 2024 | Mar. 28, 2024 | Jan. 02, 2024 | Dec. 31, 2023 |
Preferred stock, par value | $ 0.001 | $ 0.001 | |||
Preferred stock, shares authorized | 50,000,000 | 50,000,000 | |||
Common stock, par value | $ 0.001 | $ 0.001 | |||
Common stock, shares authorized | 500,000,000 | 500,000,000 | |||
Common stock, shares issued | 9,600,000 | 9,772,672 | 95,700,000 | 143,648 | 8,391,940 |
Common stock, shares outstanding | 9,600,000 | 9,772,672 | 95,700,000 | 8,391,940 | |
Series A Convertible Preferred Stock | |||||
Preferred stock, par value | $ 0.001 | $ 0.001 | |||
Preferred stock, shares authorized | 12,000,000 | 12,000,000 | |||
Preferred stock, shares issued | 0 | 3,000,000 | |||
Preferred stock, shares outstanding | 0 | 3,000,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expense: | ||
Research and development | $ 1,748 | $ 3,650 |
General and administrative | 4,250 | 5,785 |
Total operating expenses | 5,998 | 9,435 |
Loss from operations | (5,998) | (9,435) |
Other (income) expense: | ||
Interest income | (27) | (156) |
Interest expense | 230 | |
Change in fair value of convertible note payable | 318 | 1,772 |
Change in fair value of warrant liabilities | 9 | (12) |
Total other expense | 530 | 1,604 |
Net loss | (6,528) | (11,039) |
Comprehensive (income) loss: | ||
Change in fair value of convertible note attributed to credit risk | (106) | |
Other comprehensive income | (106) | |
Comprehensive loss | $ (6,528) | $ (10,933) |
Net loss per share: | ||
Basic | $ (0.74) | $ (1.66) |
Diluted | $ (0.74) | $ (1.66) |
Weighted average common shares outstanding: | ||
Basic | 8,852,286 | 6,647,391 |
Diluted | 8,852,286 | 6,647,391 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' (DEFICIT) EQUITY - USD ($) $ in Thousands | Common Stock At-the-market offering | Common Stock | Preferred Stock Series A | Additional Paid-in Capital At-the-market offering | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income Loss | At-the-market offering | Total |
Beginning balance at Dec. 31, 2022 | $ 7 | $ 230,399 | $ (222,997) | $ 7,409 | |||||
Beginning balance, shares at Dec. 31, 2022 | 6,644,299 | ||||||||
Change in fair value of convertible note attributed to credit risk | $ 106 | 106 | |||||||
Stock-based compensation | 695 | 695 | |||||||
Common stock and warrants issued, net of issuance costs | 2,545 | 2,545 | |||||||
Common stock and warrants issued, net of issuance costs, shares | 386,667 | ||||||||
Net loss | (11,039) | (11,039) | |||||||
Ending balance at Mar. 31, 2023 | $ 7 | 233,639 | (234,036) | 106 | (284) | ||||
Ending balance, shares at Mar. 31, 2023 | 7,030,966 | ||||||||
Beginning balance at Dec. 31, 2023 | $ 8 | $ 3 | 241,406 | (253,147) | (3) | (11,733) | |||
Beginning balance, shares at Dec. 31, 2023 | 8,391,940 | 3,000,000 | |||||||
Stock-based compensation | 242 | 242 | |||||||
Conversion of Series A preferred stock into common stock | $ (3) | 3 | |||||||
Conversion of Series A preferred stock into common stock, shares | 300,000 | (3,000,000) | |||||||
At-the-market "ATM" offering, net of offering costs $48 | $ 179 | $ 179 | |||||||
At-the-market "ATM" offering, net of offering costs $48, shares | 34,584 | ||||||||
Common stock and warrants issued, net of issuance costs | $ 1 | 1,343 | 1,344 | ||||||
Common stock and warrants issued, net of issuance costs, shares | 575,000 | ||||||||
Common stock and warrants issued in private placement (270,000 common stock shares to be issued) | 1,027 | 1,027 | |||||||
Common stock and warrants issued in private placement (270,000 common stock shares to be issued) (in shares) | 270,000 | ||||||||
Vesting of restricted stock awards | 57,500 | ||||||||
Shares issued as repayment of principal and interest for convertible note | $ 1 | 399 | 400 | ||||||
Shares issued as repayment of principal and interest for convertible note (in shares) | 143,648 | ||||||||
Net loss | (6,528) | (6,528) | |||||||
Ending balance at Mar. 31, 2024 | $ 10 | $ 244,599 | $ (259,675) | $ (3) | $ (15,069) | ||||
Ending balance, shares at Mar. 31, 2024 | 9,772,672 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' (DEFICIT) EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Preferred, common stock and warrants issued, issuance costs | $ 481 | $ 351 |
Common stock shares to be issued | 270,000 | |
At-the-market offering | ||
At-the-market offering, net of offering cost, | $ 48 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (6,528) | $ (11,039) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 1 | 1 |
Stock-based compensation | 242 | 695 |
Change in fair value of warrant liabilities | 9 | (12) |
Change in fair value of convertible promissory note | 318 | 1,772 |
Changes in operating assets and liabilities: | ||
Prepaid expense and other assets | 250 | 491 |
Accounts payable | 2,091 | 1,698 |
Accrued expense and other liabilities | (54) | 305 |
Net cash used in operating activities | (3,671) | (6,089) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of computer equipment | (4) | |
Net cash used in investing activities | (4) | |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Repayment of convertible note | (2,155) | |
Proceeds from issuance of common stock and warrants, net of issuance costs | 1,523 | |
Proceeds from issuance of common stock and warrants issued in private placement, net of issuance costs | 1,027 | 2,545 |
Net cash provided by financing activities | 395 | 2,545 |
Net decrease in cash and cash equivalents | (3,276) | (3,548) |
Cash and cash equivalents at beginning of period | 4,595 | 20,054 |
Cash and cash equivalents at end of period | 1,319 | $ 16,506 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 374 | |
Non-cash investing and financing activities | ||
Issuance of common stock as principal and interest repayment for convertible notes | 400 | |
Issuance of common stock warrants as offering costs | 84 | |
Conversion of Series A preferred stock into common stock | 3 | |
Warrants issued pursuant to the Alvogen Agreement amendment | $ 1,336 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2024 | |
Organization | |
Organization | 1. Organization The Business NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“ NRX ” or the “Company” ) is a clinical-stage bio-pharmaceutical company which develops and will distribute, through its wholly-owned operating subsidiaries, NeuroRx, Inc., (“ NeuroRx ”) and HOPE Therapeutics, Inc. (“ HOPE ”, and collectively with NRX and NeuroRx, the “ Company ”, “ we ”, “ us ”, or “ our ”), novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, and PTSD . All of our drug development activities are focused on the N-methyl-D-aspartate (“ NMDA ”) receptor in the brain and nervous system, a neurochemical pathway that has been disclosed in detail in our annual filings. NeuroRx is organized as a traditional research and development (“ R&D ”) company, whereas HOPE is organized as a specialty pharmaceutical company intended to distribute ketamine and other therapeutic options to clinics that serve patients with suicidal depression and PTSD. Operations The Company’s drug development activities have expanded from its original focus on development of NRX-101, a fixed dose combination of D-cycloserine (DCS) and lurasidone for the treatment of suicidal bipolar depression to encompass the development of NRX-101 for the treatment of Chronic Pain and PTSD and the development of intravenous ketamine (NRX-100/HTX-100) for the treatment of suicidal depression. The Company has just signed a Memorandum of Understanding with the Fondation FundaMental in Paris to co-develop an NMDA-targeted disease modifying treatment for schizophrenia. These additional indications have been added as the Company has gained access to clinical trials data funded by governmental entities in France and potentially in the United States which has the potential to afford the Company potential safety and efficacy data on key indications at low cost to shareholders. |
Going Concern
Going Concern | 3 Months Ended |
Mar. 31, 2024 | |
Going Concern [Abstract] | |
Going Concern | 2. Going Concern As of March 31, 2024, the Company had $1.3 million in cash and cash equivalents, excluding our access to working capital of $5.1 million from the Alvogen milestone advance, as well as approximately $2.0 million gross proceeds received in April as discussed in Note 14. Additionally, we reduced our corporate indebtedness to Streeterville LLC by $2.2 million by using our cash on hand. With the completion of enrollment in its clinical trial of NRX-101 for bipolar depression, the Company anticipates a reduction in its monthly cash expenditure. The Company’s ongoing clinical activities continue to generate losses and net cash outflows from operations. The Company plans to pursue additional equity or debt financing or refinancing opportunities in 2024 to fund ongoing clinical activities, to meet obligations under its current debt arrangements and for the general corporate purposes of the Company. Such arrangements may take the form of loans, equity offerings, strategic agreements, licensing agreements, joint ventures or other agreements. The sale of equity could result in additional dilution to the Company’s existing shareholders. The Company cannot make any assurances that additional financing will be available to it and, if available, on acceptable terms, or that it will be able to refinance its existing debt obligations which could negatively impact the Company’s business and operations and could also lead to a reduction in the Company’s operations. The Company will continue to carefully monitor the impact of its continuing operations on the Company’s working capital needs and debt repayment obligations. As such, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least twelve months from the date of issuance of these condensed consolidated financial statements. The Company may raise substantial additional funds, and if it does so, it may do so through one or more of the following: issuance of additional debt or equity and/or the completion of a licensing or other commercial transaction for one of the Company’s product candidates. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that may be necessary if the Company is unable to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies On April 1, 2024, the Company effected a reverse stock split (the “ Reverse Stock Split Common Stock 1 Basis of Presentation and Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“ GAAP ”) as determined by the Financial Accounting Standards Board (“ FASB ”) Accounting Standards Codification (“ ASC ”) and the rules and regulations of the Securities and Exchange Commission (“ SEC ”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the consolidated balance sheet, statements of operations and cash flows for the interim periods presented. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. Use of Estimates The preparation of condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in its consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s condensed consolidated financial statements relate to the fair value of the convertible note payable, fair value of stock options and warrants, and the utilization of deferred tax assets. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. Certain Risks and Uncertainties The Company’s activities are subject to significant risks and uncertainties including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements. Fair Value of Financial Instruments FASB ASC Topic 820, Fair Value Measurements ASC 820 measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. (Refer to Note 11) Concentration of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Cash equivalents are occasionally invested in certificates of deposit. The Company maintains each of its cash balances with high-quality and accredited financial institutions and accordingly, such funds are not exposed to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Deposits in financial institutions may, from time to time, exceed federally insured limits. As of March 31, 2024 the Company’s cash and cash equivalents balance within money market accounts was in excess of the U.S. federally insured limits by $0.8 million. The Company has not experienced any losses on its deposits of cash. The Company maintains a portion of its cash and cash equivalent balances in the form of a money market account with a financial institution that management believes to be creditworthy. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to be cash equivalents, including balances held in the Company’s money market accounts. The Company maintains its cash and cash equivalents with financial institutions, in which balances from time to time may exceed the U.S. federally insured limits. The objectives of the Company’s cash management policy are to safeguard and preserve funds to maintain liquidity sufficient to meet the Company’s cash flow requirements, and to attain a market rate of return. Revenue Recognition The Company accounts for revenue under FASB ASC Topic 606, Revenue for Contract with Customers ASC 606 The Company enters into contractual arrangements that may include licenses to intellectual property and research and development services. When such contractual arrangements are determined to be accounted for in accordance with ASC 606, the Company evaluates the promised good or services to determine which promises, or group of promises, represent performance obligations. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, timelines and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract. The License Agreement (the “ License Agreement Alvogen accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: i. identify the contract(s) with a customer; ii. identify the performance obligations in the contract; iii. determine the transaction price; iv. allocate the transaction price to the performance obligations within the contract; and v. recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract to determine whether each promised good or service is a performance obligation. The promised goods or services in the Company’s arrangements typically consist of a license to intellectual property and research services. The Company may provide options to additional items in such arrangements, which are accounted for as separate contracts when the customer elects to exercise such options, unless the option provides a material right to the customer. Performance obligations are promises in a contract to transfer a distinct good or service to the customer that (i) the customer can benefit from on its own or together with other readily available resources, and (ii) is separately identifiable from other promises in the contract. Goods or services that are not individually distinct performance obligations are combined with other promised goods or services until such combined group of promises meet the requirements of a performance obligation. The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable, or a combination of both. At contract inception for arrangements that include variable consideration, the Company estimates the probability and extent of consideration it expects to receive under the contract utilizing either the most likely amount method or expected amount method, whichever best estimates the amount expected to be received. The Company then considers any constraints on the variable consideration and includes in the transaction price variable consideration to the extent it is deemed probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company then allocates the transaction price to each performance obligation based on the relative standalone selling price and recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The Company records amounts as accounts receivable when the right to consideration is deemed unconditional. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded as deferred revenue. The Company’s revenue arrangements include the following: Milestone Payments: At the inception of an agreement that includes milestone payments, the Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty.) The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. Royalties: For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Research Services: The Company is incurring research costs in association with the License Agreement. After the First Milestone Payment (as defined in Note 6 below), the Company will be reimbursed for certain costs incurred related to reasonable and documented out-of-pocket costs for clinical and non-clinical development activities. The Company will recognize revenue for the reimbursed costs when the First Milestone Payment contingencies have been achieved and the Company has an enforceable claim to the reimbursed costs. See Note 6, “ Alvogen Licensing Agreement Research and Development Costs The Company’s research and development expenses consist primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in ongoing research and development efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received. Non-cancellable Contracts The Company may record certain obligations as liabilities related to non-cancellable contracts. If appropriate the offsetting costs may be recorded as a deferred cost asset. Note Payable As permitted under FASB ASC Topic 825, Financial Instruments (“ ASC 825 The Company estimates the fair value of the note payable using a Monte Carlo simulation model, which uses as inputs the fair value of its Common Stock and estimates for the equity volatility and volume volatility of its Common Stock, the time to expiration (i.e. expected term) of the note, the risk-free interest rate for a period that approximates the time to expiration, and probability of default. Therefore, the Company estimate its expected future equity and volume volatility based on the historical volatility of both its Common Stock price and Common Stock trading volume utilizing a lookback period consistent with the time to expiration. The time to expiration is based on the contractual maturity date, giving consideration to the mandatory and potential accelerated redemptions beginning six months from the issuance date. The risk-free interest rate is determined based on the U.S. Treasury yield curve in effect at the time of measurement for time periods approximately equal to the time to expiration. Probability of default is estimated using Bloomberg’s Default Risk function which uses its financial information to calculate a default risk specific to the Company. Interest expense is included within the fair value of the note payable. Management believes those assumptions are reasonable but if these assumptions change, it could materially affect the fair value. Stock-Based Compensation The Company expenses stock-based compensation to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards. The Company accounts for forfeitures as they occur. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. The Company estimates the fair value of restricted stock award grants using the closing trading price of the Company’s Common Stock on the date of issuance. All stock-based compensation costs are recorded in general and administrative or research and development costs in the condensed consolidated statements of operations and comprehensive loss based upon the underlying individual’s role at the Company. Warrants The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, Distinguishing Liabilities from Equity ASC 480 Derivatives and Hedging ASC 815 For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The fair value of the Private Placement Warrants (as defined below) was estimated using a Black Scholes valuation approach and the fair value of the Substitute Warrants (as defined below) was estimated using a modified Black Scholes valuation approach which applies a probability factor based on the probabilities of achieving earnout cash milestone and/or earnout shares milestone at each reporting period (see Notes 9 and 11). Modification of Warrants A change in any of the terms or conditions of warrants is accounted for as a modification. The accounting for incremental fair value of warrants is based on the specific facts and circumstances related to the modification which may result in a reduction of additional paid-in capital, recognition of costs for services rendered, or recognized as a deemed dividend. Preferred Stock In accordance with ASC 480, the Company’s Series A Preferred Stock was classified as permanent equity as it was not mandatorily redeemable upon an event that is considered outside of the Company’s control. Further, in accordance with ASC 815-40, Derivatives and Hedging – Contracts in an Entity’s Own Equity Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes ASC 740 expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. 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 would more likely than not be realized assuming examination by the taxing authority. 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. The Company recognizes any interest and penalties accrued related to unrecognized tax benefits as income tax expense. Loss Per Share The Company applies the two-class method when computing net income or loss per share attributable to common stockholders as the Company has issued securities that meet the definition of participating securities (See Note 9). In determining net income or loss attributable to common stockholders, the two-class method requires income or loss allocable to participating securities for the period to be allocated between common and participating securities based on their respective rights to share in the earnings as if all of the income or loss allocable for the period had been distributed. In periods of net loss, there is no allocation required under the two-class method as the participating securities do not have an obligation to fund the losses of the Company. Basic loss per share of Common Stock is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of Common Stock outstanding for the period. Diluted loss per share reflects the potential dilution that could occur if stock options, restricted stock awards and warrants were to vest and be exercised. Diluted earnings per share excludes, when applicable, the potential impact of stock options, Common Stock warrant shares, convertible notes, and other dilutive instruments because their effect would be anti-dilutive in the periods in which the Company incurs a net loss. The following outstanding shares of Common Stock equivalents were excluded from the computation of the diluted net loss per share attributable to Common Stock for the periods in which a net loss is presented because their effect would have been anti-dilutive. Three months ended March 31, 2024 2023 Stock options 175,437 254,885 Restricted stock awards 66,666 100,000 Common stock warrants 4,034,337 3,321,499 Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are adopted by the Company as of the specified effective date. For the three months ended March 31, 2024, there were no new accounting pronouncements or updates to recently issued accounting pronouncements that management believes materially affect the Company’s present or future results of operations, overall financial condition, liquidity or disclosures. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2024 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | 4. Prepaid Expense and Other Current Assets Prepaid expense and other current assets consisted of the following at the dates indicated (in thousands): March 31, 2024 December 31, 2023 (Unaudited) Prepaid expense and other current assets: Prepaid clinical development costs $ 823 $ 871 Prepaid insurance 638 1,078 Other prepaid expense 433 334 Other current assets 128 — Other current receivables 6 6 Total prepaid expense and other current assets $ 2,028 $ 2,289 |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2024 | |
Accrued and Other Current Liabilities | |
Accrued and Other Current Liabilities | 5. Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following at the dates indicated (in thousands): March 31, 2024 December 31, 2023 (Unaudited) Accrued and other current liabilities: Professional services $ 2,766 $ 2,686 Accrued research and development expense 992 1,112 Accrued employee costs 959 835 Other accrued expense 579 81 Total accrued and other current liabilities $ 5,296 $ 4,714 |
Alvogen Licensing Agreement
Alvogen Licensing Agreement | 3 Months Ended |
Mar. 31, 2024 | |
Alvogen Licensing Agreement | |
Alvogen Licensing Agreement | 6. Alvogen Licensing Agreement On June 2, 2023, the Company entered into the License Agreement with Alvogen. The Company and Alvogen are referred to below individually as a “ Party Parties License Grant Under the License Agreement, the Company granted Alvogen an exclusive (even as to the Company and its affiliates) worldwide, transferable and sublicensable license under certain intellectual property (including patents, know-how and trademarks) owned or controlled by the Company to develop (with certain limitations), manufacture, and commercialize the Company’s candidate therapeutic product, NRX-101, for the treatment of bipolar depression with suicidality. The term of the license is, on a country-by-country basis, 20 years from the first commercial sale of NRX-101 in such country, extendable by Alvogen for a two-year period upon its request made prior to the expiration of such 20-year During the term, the Company is permitted to develop additional products containing D-cycloserine in combination with one or more other active antidepressant or antipsychotic ingredients for use outside of the field of treatment of bipolar depression with suicidality, such as in post-traumatic stress disorder (PTSD) or chronic pain in depression, in which case, if the Company wishes to license rights to develop or commercialize such additional products or indications, Alvogen has a right of first negotiation to obtain such a license. Term and Termination The License Agreement will remain in force until the earlier to occur of (i) 20 years following the first commercial sale of NRX-101 on a country-by-country basis (which may be extended for a two-year period at Alvogen’s request), and (ii) the date that the agreement is terminated under its early termination provisions. Early termination grounds include, subject to applicable cure periods, a material breach of agreement by the other Party, the bankruptcy or insolvency of the other Party, or a party’s reasonable belief that there is an unacceptable risk for harm in humans based upon preclinical safety data or the observation of serious adverse effects in humans. In addition, Alvogen has the right to early termination if (i) the phase 2 study relating to NRX-101 is not completed and/or a successful read out from the study does not occur by March 31, 2024, or (ii) there is no completion of a Type B meeting with the Federal Drug Administration (“ FDA sixty 60 days Upon expiration or termination of the License Agreement, the intellectual property rights licensed to Alvogen under the License Agreement will revert to the Company, and all other rights and obligations of each of the parties will immediately cease, except for outstanding amounts owed as of the time of such expiration or termination. Upon termination, Alvogen will grant to the Company an exclusive irrevocable, perpetual, worldwide, royalty-bearing, sublicensable, transferrable license under the NDA rights to develop, manufacture, have manufactured, or commercialize the product in the field of bipolar depression with suicidality. Such reversion license would be granted by Alvogen to the Company in exchange for an equitable royalty payable by the Company to Alvogen that would be negotiated and agreed in good faith by the parties within 30 business days of such matter being presented to them. Milestone Payments In exchange for the license grant and the participation of the Company in the development, regulatory and commercial activities described below, Alvogen was obligated to pay the Company an initial $9 million cash payment upon the later of a positive data read-out from the Company’s ongoing Phase 2b/3 clinical trial and completion of the Type B meeting with the FDA (the “ First Milestone Payment Approval Payment If the first milestone is not achieved by September 3, 2024, the Company will be obligated to repay any amount received against the $5 million advance of the First Milestone Payment to Alvogen. As there is significant uncertainty relative to approval of any drug candidate in development, the Company concluded that it is not probable that a significant reversal of revenue will not occur if the Company were to include the First Milestone Payment, or any advances thereof, in the transaction price prior to receiving FDA approval. Accordingly, the transaction price is fully constrained and advances from Alvogen are recorded as a refund liability until such time as the refund right expires. Further, the Company will account for the warrants issued to Alvogen and Lotus consistent with the accounting for unfunded stock subscription agreements until such time as the uncertainty around the First Milestone is resolved. As of March 31, 2024, the refund liability was $0.5 million, which is included as a component of other current liabilities on the Company’s condensed consolidated balance sheets. Royalties Subject to certain adjustments for sublicensing and other deductions, commencing on the first commercial sale of NRX-101, Alvogen has agreed to pay to the Company tiered royalties calculated on the basis of a percentage, ranging from the low to mid-teens, of annual net sales of NRX-101 measured over the trailing four quarters. In addition, if Alvogen sublicenses NRX-101 in any country other than the U.S. (in which the royalty rates described above will apply), Alvogen will pay the Company a percentage of any and all consideration received by Alvogen or its affiliates from sublicensing any of the rights granted. Development and Regulatory Activities Prior to payment of the First Milestone Payment by Alvogen to the Company, each Party has agreed to perform, at its own cost, certain development activities using diligent efforts and in accordance with applicable then-current good manufacturing and other applicable practices, laws and regulations, with the goal of supporting the preparation and filing of an NDA and obtaining regulatory approval for NRX-101. Until the payment of the First Milestone Payment, the Company has the sole right to control and responsibility for all regulatory matters relating to NRX-101, at its sole cost and expense, and the Company shall own all regulatory materials and own all worldwide regulatory approvals for NRX-101. After the payment of the First Milestone Payment, Alvogen has the sole right and responsibility, at its cost and expense, for all regulatory matters relating to NRX-101, and Alvogen will own all regulatory materials and all regulatory approvals for the product in the licensed territory (and the Company will assign all of its rights in any regulatory materials to Alvogen). Each party has committed to reasonably cooperate with the other in carrying out the development and regulatory activities outlined in the development plan. In addition, Alvogen has agreed to fund the next registrational study of NRX-101 in the field of treatment of bipolar depression with suicidality. Upon NDA approval of the product in the U.S., Alvogen has agreed to use diligent efforts to commercialize NRX-101 in the U.S., and, for 24 months following such approval, in other countries in the territory upon regulatory approval in each such country. If Alvogen does not commercialize NRX-101 in a country outside of the U.S. in the foregoing 24-month period, then the license may revert back to the Company with respect to such country and the Company would pay Alvogen tiered royalties in the low to mid-teens based on net sales of NRX-101 in such country. The Parties will also enter into a pharmacovigilance agreement to ensure compliance with safety reporting requirements of all applicable regulatory agencies globally with respect to the commercialization of NRX-101. Commercial Activities Under the License Agreement, the Company is responsible for and will control the manufacturing of the NRX-101 commercial product and for qualification and regulatory-related activities necessary for the manufacture of the product. The Parties intend to enter into a clinical supply agreement (and a related quality agreement) on reasonable and customary terms, in which the Company will supply Alvogen raw materials and/or finished product without any markup to the future supply price from the Company’s current contract manufacturer. Similarly, prior to initiation of the first Phase 3 study for the commercial product, the Parties will enter into a commercial supply agreement (and a related quality agreement) on reasonable and customary terms, in which the Company will supply Alvogen raw materials and/or finished product without any markup to the future supply price from NRx’s current contract manufacturer. At any time after NDA approval, Alvogen may elect to manufacture, fill and package the product itself or through a third-party supplier subject to the prior approval of the Company. In such case, the parties may also work together to establish a written manufacturing technology transfer plan to transfer manufacturing technology from the Company or the Company’s contract manufacturer to Alvogen or Alvogen’s designated third party supplier. The Company has agreed, as a part of its manufacturing commitments, to make available its qualified technical personnel to consult with Alvogen to complete transfer of the manufacturing technology if required under the License Agreement. Following NDA approval, Alvogen will control and be responsible for advertising, marketing, promotion and marketing, pricing, and terms of sale for the product, all at Alvogen’s sole expense. Alvogen has committed to not shift, allocate, price or discount sales of the product for the purpose of reducing or disadvantaging the net sales of the product in order to reduce the payments owed by Alvogen to the Company under the License Agreement. As of March 31, 2024, the Company has not achieved any milestones nor recognized any revenue associated with the License Agreement. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2024 | |
Debt. | |
Debt | 7. Debt Convertible Note On November 4, 2022, the company issued an 9% redeemable promissory note (as amended, the “ Note Streeterville The initial terms of the Note included the following provisions, certain of which have subsequently been modified as described below. The Company has the option to prepay the Note during the term by paying an amount equal to 110% of the principal, interest, and fees owed as of the prepayment date. The noteholder has the right to redeem up to $1.0 million of the outstanding balance of the Note per month starting six months after the issuance date (the “ Maximum Monthly Redemption Amount Redemption Premium Redemption Conversion Price The Note contains certain Trigger Events (as defined in the Note) that generally, if uncured within five trading days, may result in an event of default in accordance with the terms of the Notes (such event, an “ Event of Default Due to these embedded features within the Note, the Company elected to account for the Note at fair value at inception. Subsequent changes in fair value are recorded as a component of other income (loss) in the Consolidated Statements of Operations. Convertible Note Amendments On March 30, 2023, the Company entered into an Amendment to the Note (the “ First Amendment On July 7, 2023, the Company entered into Amendment #2 to the Note with Streeterville (the “ Second Amendment accordance with the terms of the note amendment. However, the portion of each payment that is not satisfied by the delivery of Redemption Conversion Shares is the maximum amount of cash the Company will be required to pay in accordance with the Second Amendment during the period from July 31, 2023 and on or before the last day of each month until December 31, 2023. The redemption of the Maximum Monthly Redemption Amount in excess of the Minimum Amount may be satisfied by the delivery of additional Redemption Conversion Shares. On February 9, 2024, the Company entered into Amendment #3 to the Note (the “ Third Amendment After April 30, 2024, and for the remainder of the payment period through July 31, 2024, Streeterville may redeem any Redemption Amount (as defined in the Note), including an amount in excess of the Minimum Payment, subject to the Maximum Monthly Redemption Amount. During the period through July 31, 2024, the Company is permitted to pay the Redemption Amounts by delivery of the Redemption Conversion Shares (as defined below) without regard to the existence of any Equity Conditions Failure, to the extent Streeterville submits redemption notices during such month pursuant to the terms of the Note, and only for the Redemption Amounts covered by such notices. Moreover, the Redemption Premium will continue to apply to the Redemption Amounts. To the extent there is an outstanding balance under the Note after July 31, 2024, the Company will be required to pay such outstanding balance in full in cash by August 31, 2024. During the Minimum Payment Period (defined in the Note, as amended), the Company is permitted to pay the Redemption Amounts in the form of shares of Common Stock of the Company (the “ Redemption Conversion Shares Both the Second Amendment and the Third Amendment (considered cumulatively with the Second Amendment) were deemed to be debt modifications in accordance with FASB ASC Topic 470, Debt, which will be accounted for prospectively. The modification does not result in recognition of a gain or loss in the consolidated statement of operations but does impact interest expense recognized in future periods. Convertible Note Fair Value Measurements The Company estimates the fair value of the convertible note payable using a Monte Carlo simulation model, which uses as inputs the fair value of its Common Stock and estimates for the equity volatility and volume volatility of its Common Stock, the time to expiration of the convertible note, the risk-free interest rate for a period that approximates the time to expiration, and probability of default. Therefore, the Company estimates its expected future volatility based on the actual volatility of its Common Stock and historical volatility of its Common Stock utilizing a lookback period consistent with the time to expiration. The time to expiration is based on the contractual maturity date, giving consideration to the mandatory and potential accelerated redemptions beginning six months from the issuance date. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of measurement for time periods approximately equal to the time to expiration. Probability of default is estimated using Bloomberg's Default Risk function which uses its financial information to calculate a default risk specific to the Company. The discount to the principal amount is included in the carrying value of the Note. During 2022, the Company recorded a debt discount of approximately $1.0 million upon issuance of the Note for the original issue discount of $1.0 million. As a result of electing the fair value option, any direct costs and fees related to the Note were expensed as incurred. For the three months ended March 31, 2024 and 2023, the Company recorded a loss from the change in fair value of the Note of $0.3 million and $1.7 million, respectively, which was recognized in other (income) expense on the Consolidated Statement of Operations as a result of the Company’s election of the fair value option. During the three months ended March 31, 2024, the Company made cash payments for coupon interest on the Note of approximately $0.1 million, and $0.2 million of redemption premiums, and repayments on the Note of approximately $2.2 million and issued shares of Common Stock as principal repayment of $0.3 million. During the three months ended March 31, 2023, the Company made no payments on the Note. As of March 31, 2024, and December 31, 2023, the Note carried a remaining principal balance of $5.4 million and $8.3 million, respectively. Refer to Note 11 for the reconciliation of the fair values for the periods presented and Note 14 Subsequent Events. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 8. Commitments and Contingencies Sarah Herzog Memorial Hospital License Agreement The Company is required to make certain payments in order to maintain the license agreement with the Sarah Herzog Memorial Hospital Ezrat Nashim (“ SHMH ”), including: Milestone Payments End of Phase I Clinical Trials of Licensed Product $ 100,000 End of Phase II Clinical Trials of Licensed Product $ 250,000 End of Phase III Clinical Trials of Licensed Product $ 250,000 First Commercial Sale of Licensed Product in U.S. $ 500,000 First Commercial Sale of Licensed Product in Europe $ 500,000 Annual Revenues Reach $100,000,000 $ 750,000 The milestone payments due above may be reduced by 25% in certain circumstances, and by the application of certain sub-license fees. During the three months ended March 31, 2024 and 2023, no payments were made. Royalties A royalty in an amount equal to: (a) 1% of revenues from the sale of any product incorporating a Licensed Product when at least one Licensed Patent remains in force, if such product is not covered by a Valid Claim (as defined below) in the country or region in which the sale occurs, or (b) 2.5% of revenues from the sale of any Licensed Product that is covered by at least one Valid Claim in the country or region in which such product is manufactured or sold. A “Valid Claim” means any issued claim in the Licensed Patents that remains in force and that has not been finally invalidated or held to be unenforceable. The royalty rates above may be doubled if we commence a legal challenge to the validity, enforceability or scope of any of the Licensed Patents during the term of the SHMH License Agreement and do not prevail in such proceeding. Royalties shall also apply to any revenues generated by sub-licensees from sale of Licensed Products subject to a cap of 8.5% of the payments received by us from sub-licensees in connection with such sales. Annual Maintenance Fee A fixed amount of $100,000 was paid on April 16, 2021 and, thereafter, a fixed amount of $150,000 is due on the anniversary of such date during the term of the SHMH License Agreement. Exclusive License Agreement The Company has entered into a License Agreement with Apkarian Technologies to in-license US Patent 8,653,120 that claims the use of D-cycloserine for the treatment of chronic pain in exchange for a commitment to pay milestones and royalties as development milestones are reached in the field of chronic pain. The patent is supported by extensive nonclinical data and early clinical data that suggest the potential for NMDA antagonist drugs, such as NRX-101 to decrease both chronic pain and neuropathic pain while potentially decreasing craving for opioids. For the three months ended March 31, 2024 and 2023, the Company has recorded $0 and million recorded in Research and development expenses on the condensed consolidated statements of operations and comprehensive loss. Operating Lease The Company leases office space on a month-to-month basis. The rent expense for the three months ended March 31, 2024 and 2023 was less than $0.1 million and $0.1 million, respectively. Relief Therapeutics Collaboration Agreement On September 18, 2020, the Company entered into a collaboration agreement (the “ Collaboration Agreement On November 12, 2022, the Company entered into a Settlement Agreement and Asset Purchase Agreement (“ APA Relief Parties Under the APA, the Company transferred to the Relief Parties all of the Company’s interest in ZYESAMI (or the “ Product The Relief Parties have agreed to use commercially reasonable efforts to develop, market, and commercialize the Product, and have sole discretion to select the indications for which they will seek to develop the Product. Although the Company intends to monitor the progress of the Relief Parties under the APA and enforce the Company’s rights thereunder, there can be no assurances that the Relief Parties will be successful at commercializing the Product. Upon commercial launch of the Product by the Relief Parties or any of their affiliates, licensees or sublicensees (or upon authorization of use for any indication of the Product other than COVID-19), the Company is entitled to receive milestone payments in stages up to an aggregate amount of $13.0 million. The Relief Parties have also agreed to pay royalties to the Company on aggregate net sales of all Products, subject to a cap on royalty payments of $30.0 million in the aggregate. No royalties have been received under this agreement as of March 31, 2024. In addition, Relief is obligated to use commercially reasonable efforts to continue the Company’s existing Right to Try Program until December 2024. Mutual indemnity provisions in the APA will protect each party from any breaches of the settlement arrangements by the other party, provided, that the Company’s indemnity obligations will not start until the Relief Parties have begun making royalty or milestone payments to the Company, subject to certain exceptions. With respect to the Company, there is an indemnity threshold such that the Company will not be liable for any indemnity claims until such claims are in excess of $0.5 million (and then only for the amount above $0.5 million). The Company’s indemnity obligation is capped at $2.0 million with respect to breaches of representations and warranties and $3.0 million with respects to breaches of covenants or other agreements. Additionally, subject to certain exceptions, the Company’s indemnity obligations cannot exceed the amount that the Relief Parties actually pay to the Company for milestone and royalty payments. The parties closed the APA in December 2022 at which time all claims and counterclaims between the Company and the Relief Parties were dismissed with prejudice. Legal Proceedings From time to time the Company is involved in litigation, claims, and other proceedings arising in the ordinary course of business. Litigation and other disputes are inherently unpredictable and subject to substantial uncertainties and unfavorable resolutions could occur. Other Legal Actions: The Company is currently involved in and may from time to time become involved in various legal actions incidental to our business. As of the date of this report, the Company is not involved in any legal proceedings that it believes could have a material adverse effect on its financial position or results of operations. However, the outcome of any current or future legal proceeding is inherently difficult to predict and any dispute resolved unfavorably could have a material adverse effect on The Company’s business, financial position, and operating results. |
Equity
Equity | 3 Months Ended |
Mar. 31, 2024 | |
Equity | |
Equity | 9. Equity Common Stock Reverse Stock Split On March 21, 2024, the Board approved a reverse stock split ratio of 1 Amendment Effective Time At the Effective Time of April 1, 2024, every 10 issued and outstanding shares of the Company’s Common Stock were converted automatically into one share of the Company’s Common Stock, without any change in the par value per share. The Reverse Stock Split reduced the number of shares of Common Stock issued and outstanding from approximately 95.7 million to approximately 9.6 million. No fractional shares were issued in connection with the Reverse Stock Split. Shareholders who otherwise would have been entitled to receive a fractional share instead became entitled to receive one whole share of Common Stock in lieu of such fractional share. All share and per share amounts in the accompanying condensed consolidated financial statements and footnotes have been retrospectively adjusted for the reverse split. Preferred Stock Pursuant to the terms of the Company’s Second Amended and Restated Certificate of Incorporation, the Company has 50,000,000 shares of preferred stock with a par value of $0.001, of which 12,000,000 were designated Series A convertible preferred stock. In August 2023, the Company sold and issued 3.0 million shares of Series A convertible preferred stock for an aggregate cash purchase price of $1.2 million. During March 2024 holders of the Company’s Series A convertible preferred stock elected to convert 3,000,000 shares of Series A convertible preferred stock into 300,000 shares of Common Stock. As of March 31, 2024, no shares of Series A convertible preferred stock remained issued or outstanding. Common Stock Pursuant to the terms of the Company’s Second Amended and Restated Certificate of Incorporation, the Company has authorized 500,000,000 shares of with a par value of $0.001 . On January 2, 2024, the Company issued 143,648 shares of Common Stock as payment for the $0.4 million minimum payment to Streeterville related to principal and interest payments on the Streeterville Note. From February 20, 2024 to March 11, 2024, the Company announced that it entered into multiple purchase agreements (the “ ATM Purchase Agreements On February 29, 2024, the Company entered into a securities purchase agreement with an investor providing for the issuance and sale of 270,000 shares of Common Stock and warrants to purchase up to 270,000 shares of Common Stock (the “ February Warrants offered pursuant to a private placement (the “ February 2024 Private Placement Securities Act On February 27, 2024, the Company entered into an underwriting agreement (the “ February Underwriting Agreement Representative February Underwriters February 2024 Public Offering February Shares 45 February Option Shares February Over-Allotment Option February Closing Date February Overallotment Exercise Common Stock Warrants Substitute Warrants In connection with the Merger in 2021, each warrant to purchase shares of Common Stock of NeuroRx that was outstanding and unexercised immediately prior to the effective time (whether vested or unvested) was assumed by BRPA and converted into a warrant, based on the Exchange Ratio (of 0.316), that will continue to be governed by substantially the same terms and conditions, including vesting, as were applicable to the former warrant (the “ Substitute Warrants The Company recognized a loss (gain) on the change in fair value of the Substitute Warrants for the three months ended March 31, 2024 and 2023 of less than $0.1 million and less than $0.1 million, respectively. Refer to Note 11 for further discussion of fair value measurement of the warrant liabilities. Assumed Public Warrants Prior to the Merger, the Company had 3,450,000 Public Warrants outstanding (the “ Public Warrants During the three months ended March 31, 2024 and 2023 no Public Warrants were exercised. The outstanding balance of these warrants remains in equity. At March 31, 2024 and December 31, 2023, there were 3,448,856 Public Warrants outstanding to purchase up to 344,886 shares of Common Stock. Assumed Private Placement Warrants Prior to the Merger, the Company had outstanding 136,250 Private Placement Warrants (the “ Private Placement Warrants ”) to purchase up to 13,625 shares of Common Stock. The Private Placement Warrants are not indexed to the Company’s common shares in the manner contemplated by 815-40-15 because the holder of the instrument is not an input into the pricing of a fixed-for-fixed option on equity shares. The Company classifies the Private Placement Warrants as derivative liabilities in its condensed consolidated balance sheets as of March 31, 2024 and December 31, 2023. The Company measures the fair value of the Private Placement Warrants at the end of each reporting period and recognizes changes in the fair value from the prior period in the Company’s statements of operations for the current period. The Company recognized a loss (gain) on the change in fair value of the Private Placement Warrants for the three months ended March 31, 2024 and 2023 of less than $0.1 million, respectively. Refer to Note 11 for discussion of the fair value measurement of the Company’s warrant liabilities. Investor Warrants As discussed above, on February 28, 2024, in conjunction with the sale of shares of the Company’s Common Stock, On February 28, 2024, the Company issued to the Representative the Underwriter’s Warrant to purchase up to 25,000 shares of Common Stock (the “ February Underwriter Warrant Shares On March 5, 2024 the Company issued Alvogen Warrants In conjunction with the amended Alvogen licensing agreement discussed in Note 6, on February 7, 2024 the Company issued Weighted Average Weighted Aggregate Total Remaining Average Intrinsic Value Warrant Shares Term Exercise Price (in thousands) Outstanding as of December 31, 2023 3,321,499 3.91 $ 23.01 $ 180 Issued 718,348 Expired (5,510) Outstanding as of March 31, 2024 4,034,337 3.68 $ 19.61 $ 807 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation | |
Stock-Based Compensation | 10. Stock-Based Compensation 20 16 Omnibus Incentive Plan Prior to the Merger, NeuroRx maintained its 2016 Omnibus Incentive Plan (the “ 2016 Plan In connection with the Merger, each option of NeuroRx that was outstanding and unexercised immediately prior to the Effective Time (whether vested or unvested) was assumed by BRPA and converted into an option to acquire an adjusted number of shares of Common Stock at an adjusted exercise price per share, based on the Exchange Ratio (of 0.316:1). Upon the closing of the Merger, the outstanding and unexercised NeuroRx stock options became options to purchase an aggregate 289,542 shares of the Company’s Common Stock at an average exercise price of $51.00 per share. 2021 Omnibus Incentive Plan As of March 31, 2024, 955,281 shares of Common Stock are authorized for issuance pursuant to awards under the Company’s 2021 Omnibus Incentive Plan (the “ 2021 Plan an evergreen feature that automatically increases the reserve with additional shares of for future issuance under the Incentive Plan each calendar year, beginning January 1, 2022 and ending on and including January 1, 2031, equal to the lesser of (A) 1% of the shares of Common Stock outstanding on the final day of the immediately preceding calendar year or (B) a smaller number of shares determined by the Board. On December 28, 2023 the first amendment to the 2021 Omnibus Plan was executed which Option Awards The fair value of each employee and non-employee stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company is a public company and has limited company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the limited company-specific historical volatility and implied volatility. The expected term of the Company’s stock options for employees has been determined utilizing the “simplified” method for awards. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. Additionally, certain options granted contain terms that require all unvested options to immediately vest a) upon the approval of an NDA by the FDA for NRX-101, or b) immediately preceding a change in control of the Company, whichever occurs first. The Company issued no stock options during the three months ended March 31, 2024 and 2023. The following table summarizes the Company’s employee and non-employee stock option activity under the 2021 Plan for the following periods: Number of shares Weighted average exercise price Weighted average remaining contractual life (in years) Aggregate intrinsic value (in thousands) Outstanding as of December 31, 2023 264,983 $ 18.30 7.7 $ 75 Expired/Forfeited (89,546) Outstanding as of March 31, 2024 175,437 $ 18.60 8.4 $ 40 Options vested and exercisable as of March 31, 2024 105,215 $ 27.61 7.6 $ 1 Stock-based compensation expense related to stock options was less than $0.1 million and $0.7 million for the three months ended March 31, 2024 and 2023, respectively. At March 31, 2024, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted, was $0.3 million, which the Company expects to recognize over a weighted-average period of approximately 1.1 years. Restricted Stock Awards The following table presents the Company’s Restricted Stock Activity: Awards Weighted Average Grant Date Fair Value Balance as of December 31, 2023 (unvested) 124,166 $ 5.20 Vested (57,500) 4.64 Balance as of March 31, 2024 (unvested) 66,666 $ 5.66 On July 12, 2022, the Board granted an award of 100,000 restricted shares of the Company (“ RSAs 3 On December 28, 2023, the Company was authorized to grant 57,500 RSAs to a consultant for services provided. The RSAs vested after six Stock-based compensation expense related to RSAs was $0.2 million and less than $0.1 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, total unrecognized compensation expense related to RSAs was approximately $ 0.2 million, which is expected to be recognized over a weighted-average period of approximately 1.3 years. The following table summarizes the Company’s recognition of stock-based compensation for the following periods (in thousands): Three months ended March 31, 2024 2023 (Unaudited) Stock-based compensation expense General and administrative $ 211 $ 591 Research and development 31 104 Total stock-based compensation expense $ 242 $ 695 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements | |
Fair Value Measurements | 11. Fair Value Measurements Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the three months ended March 31, 2024 and 2023. The carrying amount of accounts payable approximated fair value as they are short term in nature. The fair value of stock options and warrants issued for services are estimated based on the Black-Scholes model. The fair value of the Note was estimated utilizing a Monte Carlo simulation. Fair Value on a Recurring Basis The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually. The estimated fair value of the money market account represents a Level 1 measurement. The estimated fair value of the warrant liabilities and convertible note payable represent Level 3 measurements. The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis at March 31, 2024 and December 31, 2023, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value (in thousands): Description Level March 31, 2024 December 31, 2023 Assets: (Unaudited) Money Market Account 1 $ 566 $ 3,874 Liabilities: Warrant liabilities (Note 9) 3 $ 26 $ 17 Convertible note payable (Note 7) 3 $ 6,779 $ 9,161 Convertible Note Payable The significant inputs used in the Monte Carlo simulation to measure the convertible note liability that is categorized within Level 3 of the fair value hierarchy are as follows: March 31, 2024 2023 Stock price on valuation date $ 4.70 $ 6.60 Time to expiration 0.42 1.09 Note market interest rate 16.5 % 17.1 % Equity volatility 135.0 % 125.0 % Volume volatility 575 % 420 % Risk-free rate 5.40 % 4.58 % Probability of default 14.2 % 14.6 % The following table sets forth a summary of the changes in the fair value of the Note categorized within Level 3 of the fair value hierarchy (in thousands): Fair value of the Note as of December 31, 2023 $ 9,161 Conversions and repayments of principal and interest (shares and cash) (2,700) Fair value adjustment through earnings 318 Fair value adjustment through accumulated other comprehensive loss — Fair value of the Note as of March 31, 2024 $ 6,779 Convertible note payable - current portion $ 6,779 Convertible note payable, net of current portion $ — Fair value of the Note as of December 31, 2022 $ 10,525 Conversions and repayments of principal and interest (shares and cash) — Fair value adjustment through earnings 1,770 Fair value adjustment through accumulated other comprehensive loss (106) Fair value of the Note as of March 31, 2023 $ 12,189 Convertible note payable - current portion $ 12,189 Convertible note payable, net of current portion $ — Warrant Liabilities The Company utilizes a Black-Scholes model approach to value the Private Placement Warrants and Substitute Warrants at each reporting period, with changes in fair value recognized in the statement of operations. The estimated fair value of the warrant liabilities is determined using Level 3 inputs. There were no transfers between levels within the fair value hierarchy during the periods presented. Inherent in a Black Scholes options pricing model are assumptions related to expected share-price volatility, expected life, risk-free interest rate and dividend yield. The Company estimates the volatility of its Common Stock based on historical volatility that matches the expected remaining life of the warrants. The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected remaining life of the warrants. The expected life of the warrants is assumed to be equivalent to their remaining contractual term. The dividend rate is based on the historical rate, which the Company anticipates remaining at zero. The significant inputs used in the Black-Scholes model to measure the warrant liabilities that are categorized within Level 3 of the fair value hierarchy are as follows: March 31, 2024 2023 Stock price on valuation date $ 4.70 $ 6.60 Exercise price per share $ 115.00 $ 115.00 Expected life 2.15 3.15 Volatility 178.1% 123.6% Risk-free rate 4.56% 4.77% Dividend yield 0.00% 0.00% Fair value of warrants $ 1.90 $ 1.90 A reconciliation of warrant liabilities is included below (in thousands): Balance as of December 31, 2023 $ 17 Loss upon re-measurement 9 Balance as of March 31, 2024 $ 26 Balance as of December 31, 2022 $ 37 Gain upon re-measurement (12) Balance as of March 31, 2023 $ 25 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Taxes | |
Income Taxes | 12. Income Taxes The Company recorded no provision or benefit for income tax expense for the three months ended March 31, 2024 and 2023, respectively. For all periods presented, the pretax losses incurred by the Company received no corresponding tax benefit because the Company concluded that it is more likely than not that the Company will be unable to realize the value of any resulting deferred tax assets. The Company will continue to assess its position in future periods to determine if it is appropriate to reduce a portion of its valuation allowance in the future. The Company has no open tax audits with any taxing authority as of March 31, 2024. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2024 | |
Related Party Transactions | |
Related Party Transactions | 13. Related Party Transactions Glytech Agreement The Company licenses patents that are owned by Glytech, LLC (“ Glytech Glytech Agreement The Fourth Amendment to the Glytech Agreement, effective as of December 31, 2020, includes an equity value-triggered transfer of Excluded Technology from Glytech to the Company. The Excluded Technology is defined in the Glytech Agreement as any technology, and any know-how related thereto, covered in the licensed patents that do not recite either D-cycloserine or lurasidone individually or jointly. This definition would cover pharmaceutical formulations, including some that the Company considers “pipeline” or “future product” opportunities, that contain a combination of pharmaceutical components different from those contained in NRX-100 and NRX-101. On November 6, 2022 the Glytech Agreement was amended whereby Glytech agreed to transfer and assign the remainder of the Licensed Technology and the Excluded Technology to the Company for no additional consideration at any time upon receipt of written notice from the Company if, on or prior to March 31, 2024, (i) the value of the Glytech equity holdings in the Company (the “ Glytech Equity Consulting Agreement with Dr. Jonathan Javitt The Chief Scientist of the Company, Dr. Jonathan Javitt, is a major shareholder in the Company and a member of the Board of Directors. Therefore, his services are deemed to be a related party transaction. He served the Company on a full-time basis as CEO under an employment agreement with the Company until March 8, 2022 and currently serves under a Consulting Agreement with the Company as Chief Scientist thereafter and received compensation of $0.2 million and $0.3 million during the three months ended March 31, 2024 and 2023, respectively. On March 29, 2023, the Consulting Agreement dated March 8, 2022 between the Company and Dr. Jonathan Javitt was amended to extend the term of the Agreement until March 8, 2024 with automatic annual renewals thereafter unless one party or the other provides notice of non-renewal (the “ Javitt Amendment The Javitt Amendment also provides, subject to the approval of the Board of Directors, for a grant of 50,000 shares of restricted stock of the Company under the Company’s 2021 Omnibus Incentive Plan. The restrictions are performance based, and half of the restricted shares (25,000) shall have the restrictions removed on the New Drug Application Date (as defined below) and the remaining half (25,000) will have the restrictions removed on the New Drug Approval Date (as defined below). As of March 31, 2024, the Board of Directors has not approved the grant of restricted stock. The term “New Drug Application Date” means the date upon which the FDA files the Company’s new drug application for the Antidepressant Drug Regimen (as defined below) for review. The term “New Drug Approval Date” means date upon which the FDA has both approved the Company’s Antidepressant Drug Regimen and listed the Company’s Antidepressant Drug Regimen in the FDA’s “Orange Book”. The term “Antidepressant Drug Regimen” means NRX-101, a proprietary fixed-dose combination capsule of d-cycloserine and Lurasidone, administered for sequential weeks of daily oral treatment following patient stabilization using a single infusion of NRX-100 (ketamine) or another standard of care therapy. Consulting Agreement with Zachary Javitt Zachary Javitt is the son of Dr. Jonathan Javitt. Zachary Javitt provides services related to website, IT, and marketing support under the supervision of the Company’s CEO who is responsible for assuring that the services are provided on financial terms that are at market. The Company paid this family member a total of $0.1 million and $0.1 million during the three months ended March 31, 2024 and 2023, respectively. These services are ongoing. Included in accounts payable were less than $0.1 million and less than $0.1 million due to the above related parties as of March 31, 2024 and December 31, 2023, respectively. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events | |
Subsequent Events | 14. Subsequent Events Share Issuance Pursuant to Reverse Stock Split No fractional shares were issued as a result of the Reverse Stock Split, rather, the fractional shares of Common Stock were rounded up to the nearest whole share. As a result, the Company issued 73,040 of newly issued Common Stock to the Company's existing stockholders in April 2024. Convertible Note On April 24, 2024, the Company received written notice from counsel for Streeterville that an alleged event of default occurred with respect to the Note (as defined in Note 7) , issued by the Company in favor of Streeterville, pursuant to that certain Securities Purchase Agreement dated November 4, 2022 by and between the Company and Streeterville (the “ SPA ”). The Notice alleges that, among other things, (i) the announcement of the plan to partially spin-off of the Company’s wholly-owned subsidiary, Hope Therapeutics, Inc. (the “ Spin-Off ”), constituted a “Fundamental Transaction” (as defined in the Note”) for which the Company failed to obtain Streeterville’s prior written consent before undertaking such transaction; and (ii) the Company failed to pay the Minimum Payment, as defined under Section 4 of the Note, by April 8, 2024, following a Redemption Notice issued on April 3, 2024 by Streeterville to the Company, each of which resulted in the failure to cure a Trigger Event and subsequent Event of Default of the Note, and as a result, Streeterville was therefore accelerating all of the outstanding amounts due thereunder. The Company has also learned that Streeterville filed a complaint (the “ Complaint ”) naming the Company as a defendant in the Third Judicial District Court of Salt Lake County, Utah. The Complaint is seeking, among other things: (i) declaratory relief for an order enjoining the Company from undertaking any Fundamental Transaction, including the Spin-Off, or otherwise issuing or other equity securities (such as the shares of the Company pursuant to the announced Spin-Off); and (ii) repayment of the Note and other unspecified amounts of damages, costs and fees, but no less than $6.5 million, or the amounts currently outstanding under the Note. Increase in At-The-Market Offering Agreement On April 15, 2024, the Company increased the maximum aggregate offering amount of the shares of Common Stock issuable under that certain At the Market Offering Agreement, dated August 14, 2023 (the “ Offering Agreement ”), with H.C. Wainwright & Co., and filed a prospectus supplement (the “ Current Prospectus Supplement ”) under the Offering Agreement for an aggregate of $4.9 million. Prior to the date hereof, the Company sold shares of Common Stock having an aggregate sales price of $1.0 million under the Offering Agreement. Subsequent to March 31, 2024, the Company sold additional shares of Common Stock at an aggregate sales price of $1.3 million. April 2024 Offering On April 18, 2024, we entered into an underwriting agreement (the “ April Underwriting Agreement Representative April Underwriters April Shares 45-day April Option Shares April Closing Date Aggregate gross proceeds from the April Offering were approximately $2.0 million, before deducting underwriting discounts and commissions and estimated expenses payable by the Company of approximately $0.3 million. The Company intends to use the net proceeds from the April Offering for working capital and general corporate purposes, including its plan to initiate a national treatment protocol and safety database Pursuant to the April Underwriting Agreement, the Company agreed to issue to the Representative in connection with the April Offering, a warrant to purchase up to a number of shares of Common Stock representing 5.0% of the April Shares and any April Option Shares sold, at an initial exercise price of $3.63 per share, subject to certain adjustments (the “ April Underwriter’s Warrant April Underwriter Warrant Shares The April Offering was made pursuant to the Company’s registration statement on Form S-3 (File No. 333-265492), as amended, previously filed with the SEC on June 9, 2022, and declared effective on June 21, 2022, a base prospectus dated June 21, 2022, and a prospectus supplement dated April 18, 2024. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“ GAAP ”) as determined by the Financial Accounting Standards Board (“ FASB ”) Accounting Standards Codification (“ ASC ”) and the rules and regulations of the Securities and Exchange Commission (“ SEC ”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the consolidated balance sheet, statements of operations and cash flows for the interim periods presented. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in its consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s condensed consolidated financial statements relate to the fair value of the convertible note payable, fair value of stock options and warrants, and the utilization of deferred tax assets. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. |
Certain Risks and Uncertainties | Certain Risks and Uncertainties The Company’s activities are subject to significant risks and uncertainties including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments FASB ASC Topic 820, Fair Value Measurements ASC 820 measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. (Refer to Note 11) |
Concentration of Credit Risk and Off-Balance Sheet Risk | Concentration of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Cash equivalents are occasionally invested in certificates of deposit. The Company maintains each of its cash balances with high-quality and accredited financial institutions and accordingly, such funds are not exposed to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Deposits in financial institutions may, from time to time, exceed federally insured limits. As of March 31, 2024 the Company’s cash and cash equivalents balance within money market accounts was in excess of the U.S. federally insured limits by $0.8 million. The Company has not experienced any losses on its deposits of cash. The Company maintains a portion of its cash and cash equivalent balances in the form of a money market account with a financial institution that management believes to be creditworthy. |
Revenue Recognition | Revenue Recognition The Company accounts for revenue under FASB ASC Topic 606, Revenue for Contract with Customers ASC 606 The Company enters into contractual arrangements that may include licenses to intellectual property and research and development services. When such contractual arrangements are determined to be accounted for in accordance with ASC 606, the Company evaluates the promised good or services to determine which promises, or group of promises, represent performance obligations. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, timelines and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract. The License Agreement (the “ License Agreement Alvogen accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: i. identify the contract(s) with a customer; ii. identify the performance obligations in the contract; iii. determine the transaction price; iv. allocate the transaction price to the performance obligations within the contract; and v. recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract to determine whether each promised good or service is a performance obligation. The promised goods or services in the Company’s arrangements typically consist of a license to intellectual property and research services. The Company may provide options to additional items in such arrangements, which are accounted for as separate contracts when the customer elects to exercise such options, unless the option provides a material right to the customer. Performance obligations are promises in a contract to transfer a distinct good or service to the customer that (i) the customer can benefit from on its own or together with other readily available resources, and (ii) is separately identifiable from other promises in the contract. Goods or services that are not individually distinct performance obligations are combined with other promised goods or services until such combined group of promises meet the requirements of a performance obligation. The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable, or a combination of both. At contract inception for arrangements that include variable consideration, the Company estimates the probability and extent of consideration it expects to receive under the contract utilizing either the most likely amount method or expected amount method, whichever best estimates the amount expected to be received. The Company then considers any constraints on the variable consideration and includes in the transaction price variable consideration to the extent it is deemed probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company then allocates the transaction price to each performance obligation based on the relative standalone selling price and recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The Company records amounts as accounts receivable when the right to consideration is deemed unconditional. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded as deferred revenue. The Company’s revenue arrangements include the following: Milestone Payments: At the inception of an agreement that includes milestone payments, the Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty.) The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. Royalties: For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Research Services: The Company is incurring research costs in association with the License Agreement. After the First Milestone Payment (as defined in Note 6 below), the Company will be reimbursed for certain costs incurred related to reasonable and documented out-of-pocket costs for clinical and non-clinical development activities. The Company will recognize revenue for the reimbursed costs when the First Milestone Payment contingencies have been achieved and the Company has an enforceable claim to the reimbursed costs. See Note 6, “ Alvogen Licensing Agreement |
Research and Development Costs | Research and Development Costs The Company’s research and development expenses consist primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in ongoing research and development efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received. |
Note Payable | Note Payable As permitted under FASB ASC Topic 825, Financial Instruments (“ ASC 825 The Company estimates the fair value of the note payable using a Monte Carlo simulation model, which uses as inputs the fair value of its Common Stock and estimates for the equity volatility and volume volatility of its Common Stock, the time to expiration (i.e. expected term) of the note, the risk-free interest rate for a period that approximates the time to expiration, and probability of default. Therefore, the Company estimate its expected future equity and volume volatility based on the historical volatility of both its Common Stock price and Common Stock trading volume utilizing a lookback period consistent with the time to expiration. The time to expiration is based on the contractual maturity date, giving consideration to the mandatory and potential accelerated redemptions beginning six months from the issuance date. The risk-free interest rate is determined based on the U.S. Treasury yield curve in effect at the time of measurement for time periods approximately equal to the time to expiration. Probability of default is estimated using Bloomberg’s Default Risk function which uses its financial information to calculate a default risk specific to the Company. Interest expense is included within the fair value of the note payable. Management believes those assumptions are reasonable but if these assumptions change, it could materially affect the fair value. |
Stock-Based Compensation | Stock-Based Compensation The Company expenses stock-based compensation to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards. The Company accounts for forfeitures as they occur. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. The Company estimates the fair value of restricted stock award grants using the closing trading price of the Company’s Common Stock on the date of issuance. All stock-based compensation costs are recorded in general and administrative or research and development costs in the condensed consolidated statements of operations and comprehensive loss based upon the underlying individual’s role at the Company. |
Warrants | Warrants The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, Distinguishing Liabilities from Equity ASC 480 Derivatives and Hedging ASC 815 For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The fair value of the Private Placement Warrants (as defined below) was estimated using a Black Scholes valuation approach and the fair value of the Substitute Warrants (as defined below) was estimated using a modified Black Scholes valuation approach which applies a probability factor based on the probabilities of achieving earnout cash milestone and/or earnout shares milestone at each reporting period (see Notes 9 and 11). |
Modification of warrants | Modification of Warrants A change in any of the terms or conditions of warrants is accounted for as a modification. The accounting for incremental fair value of warrants is based on the specific facts and circumstances related to the modification which may result in a reduction of additional paid-in capital, recognition of costs for services rendered, or recognized as a deemed dividend. |
Preferred Stock | Preferred Stock In accordance with ASC 480, the Company’s Series A Preferred Stock was classified as permanent equity as it was not mandatorily redeemable upon an event that is considered outside of the Company’s control. Further, in accordance with ASC 815-40, Derivatives and Hedging – Contracts in an Entity’s Own Equity |
Income Taxes | Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes ASC 740 expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. 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 would more likely than not be realized assuming examination by the taxing authority. 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. The Company recognizes any interest and penalties accrued related to unrecognized tax benefits as income tax expense. |
Loss Per Share | Loss Per Share The Company applies the two-class method when computing net income or loss per share attributable to common stockholders as the Company has issued securities that meet the definition of participating securities (See Note 9). In determining net income or loss attributable to common stockholders, the two-class method requires income or loss allocable to participating securities for the period to be allocated between common and participating securities based on their respective rights to share in the earnings as if all of the income or loss allocable for the period had been distributed. In periods of net loss, there is no allocation required under the two-class method as the participating securities do not have an obligation to fund the losses of the Company. Basic loss per share of Common Stock is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of Common Stock outstanding for the period. Diluted loss per share reflects the potential dilution that could occur if stock options, restricted stock awards and warrants were to vest and be exercised. Diluted earnings per share excludes, when applicable, the potential impact of stock options, Common Stock warrant shares, convertible notes, and other dilutive instruments because their effect would be anti-dilutive in the periods in which the Company incurs a net loss. The following outstanding shares of Common Stock equivalents were excluded from the computation of the diluted net loss per share attributable to Common Stock for the periods in which a net loss is presented because their effect would have been anti-dilutive. Three months ended March 31, 2024 2023 Stock options 175,437 254,885 Restricted stock awards 66,666 100,000 Common stock warrants 4,034,337 3,321,499 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are adopted by the Company as of the specified effective date. For the three months ended March 31, 2024, there were no new accounting pronouncements or updates to recently issued accounting pronouncements that management believes materially affect the Company’s present or future results of operations, overall financial condition, liquidity or disclosures. |
Non-cancellable contracts | Non-cancellable Contracts The Company may record certain obligations as liabilities related to non-cancellable contracts. If appropriate the offsetting costs may be recorded as a deferred cost asset. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to be cash equivalents, including balances held in the Company’s money market accounts. The Company maintains its cash and cash equivalents with financial institutions, in which balances from time to time may exceed the U.S. federally insured limits. The objectives of the Company’s cash management policy are to safeguard and preserve funds to maintain liquidity sufficient to meet the Company’s cash flow requirements, and to attain a market rate of return. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies | |
Schedule of Outstanding Shares of Common Stock Equivalents Excluded From Diluted Net Loss Per Share | Three months ended March 31, 2024 2023 Stock options 175,437 254,885 Restricted stock awards 66,666 100,000 Common stock warrants 4,034,337 3,321,499 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | Prepaid expense and other current assets consisted of the following at the dates indicated (in thousands): March 31, 2024 December 31, 2023 (Unaudited) Prepaid expense and other current assets: Prepaid clinical development costs $ 823 $ 871 Prepaid insurance 638 1,078 Other prepaid expense 433 334 Other current assets 128 — Other current receivables 6 6 Total prepaid expense and other current assets $ 2,028 $ 2,289 |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accrued and Other Current Liabilities | |
Schedule of Accrued and other current liabilities | Accrued and other current liabilities consisted of the following at the dates indicated (in thousands): March 31, 2024 December 31, 2023 (Unaudited) Accrued and other current liabilities: Professional services $ 2,766 $ 2,686 Accrued research and development expense 992 1,112 Accrued employee costs 959 835 Other accrued expense 579 81 Total accrued and other current liabilities $ 5,296 $ 4,714 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies. | |
Schedule of milestone payment related to license agreement | End of Phase I Clinical Trials of Licensed Product $ 100,000 End of Phase II Clinical Trials of Licensed Product $ 250,000 End of Phase III Clinical Trials of Licensed Product $ 250,000 First Commercial Sale of Licensed Product in U.S. $ 500,000 First Commercial Sale of Licensed Product in Europe $ 500,000 Annual Revenues Reach $100,000,000 $ 750,000 |
Equity (Tables)
Equity (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Equity | |
Summary of activity for warrants | Weighted Average Weighted Aggregate Total Remaining Average Intrinsic Value Warrant Shares Term Exercise Price (in thousands) Outstanding as of December 31, 2023 3,321,499 3.91 $ 23.01 $ 180 Issued 718,348 Expired (5,510) Outstanding as of March 31, 2024 4,034,337 3.68 $ 19.61 $ 807 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation | |
Schedule of stock option activity | Number of shares Weighted average exercise price Weighted average remaining contractual life (in years) Aggregate intrinsic value (in thousands) Outstanding as of December 31, 2023 264,983 $ 18.30 7.7 $ 75 Expired/Forfeited (89,546) Outstanding as of March 31, 2024 175,437 $ 18.60 8.4 $ 40 Options vested and exercisable as of March 31, 2024 105,215 $ 27.61 7.6 $ 1 |
Schedule of restricted stock activity | Awards Weighted Average Grant Date Fair Value Balance as of December 31, 2023 (unvested) 124,166 $ 5.20 Vested (57,500) 4.64 Balance as of March 31, 2024 (unvested) 66,666 $ 5.66 |
Summary of recognition of stock-based compensation | The following table summarizes the Company’s recognition of stock-based compensation for the following periods (in thousands): Three months ended March 31, 2024 2023 (Unaudited) Stock-based compensation expense General and administrative $ 211 $ 591 Research and development 31 104 Total stock-based compensation expense $ 242 $ 695 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Summary of fair value hierarchy | The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis at March 31, 2024 and December 31, 2023, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value (in thousands): Description Level March 31, 2024 December 31, 2023 Assets: (Unaudited) Money Market Account 1 $ 566 $ 3,874 Liabilities: Warrant liabilities (Note 9) 3 $ 26 $ 17 Convertible note payable (Note 7) 3 $ 6,779 $ 9,161 |
Schedule of measure the convertible note liability | March 31, 2024 2023 Stock price on valuation date $ 4.70 $ 6.60 Time to expiration 0.42 1.09 Note market interest rate 16.5 % 17.1 % Equity volatility 135.0 % 125.0 % Volume volatility 575 % 420 % Risk-free rate 5.40 % 4.58 % Probability of default 14.2 % 14.6 % |
Schedule of significant unobservable inputs | March 31, 2024 2023 Stock price on valuation date $ 4.70 $ 6.60 Exercise price per share $ 115.00 $ 115.00 Expected life 2.15 3.15 Volatility 178.1% 123.6% Risk-free rate 4.56% 4.77% Dividend yield 0.00% 0.00% Fair value of warrants $ 1.90 $ 1.90 |
Common stock warrants | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Schedule of reconciliation of liabilities | A reconciliation of warrant liabilities is included below (in thousands): Balance as of December 31, 2023 $ 17 Loss upon re-measurement 9 Balance as of March 31, 2024 $ 26 Balance as of December 31, 2022 $ 37 Gain upon re-measurement (12) Balance as of March 31, 2023 $ 25 |
Convertible notes payable | Level 3 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Summary of Convertible note payable | The following table sets forth a summary of the changes in the fair value of the Note categorized within Level 3 of the fair value hierarchy (in thousands): Fair value of the Note as of December 31, 2023 $ 9,161 Conversions and repayments of principal and interest (shares and cash) (2,700) Fair value adjustment through earnings 318 Fair value adjustment through accumulated other comprehensive loss — Fair value of the Note as of March 31, 2024 $ 6,779 Convertible note payable - current portion $ 6,779 Convertible note payable, net of current portion $ — Fair value of the Note as of December 31, 2022 $ 10,525 Conversions and repayments of principal and interest (shares and cash) — Fair value adjustment through earnings 1,770 Fair value adjustment through accumulated other comprehensive loss (106) Fair value of the Note as of March 31, 2023 $ 12,189 Convertible note payable - current portion $ 12,189 Convertible note payable, net of current portion $ — |
Organization (Details)
Organization (Details) - NRX-101 - License Agreement - Alvogen | Jun. 02, 2023 |
Related Party Transaction [Line Items] | |
Initial term | 20 years |
Renewal term | 2 years |
Going Concern (Details)
Going Concern (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 05, 2024 | Feb. 28, 2024 | Mar. 31, 2024 | Feb. 29, 2024 | Dec. 31, 2023 |
Debt Instrument [Line Items] | |||||
Cash and cash equivalents | $ 1.3 | ||||
Warrants, exercise price per share | $ 3.80 | $ 19.61 | $ 23.01 | ||
Number of shares issued | 3,750 | 270,000 | |||
Preferred stock, par value | 0.001 | 0.001 | |||
Series A Convertible Preferred Stock | |||||
Debt Instrument [Line Items] | |||||
Preferred stock, par value | $ 0.001 | $ 0.001 | |||
Securities Purchase Agreement | |||||
Debt Instrument [Line Items] | |||||
Warrants, exercise price per share | $ 3.80 | ||||
Alvogen Milestone Advance [Member] | |||||
Debt Instrument [Line Items] | |||||
Cash and cash equivalents | $ 5.1 | ||||
Proceeds received in April [Member] | |||||
Debt Instrument [Line Items] | |||||
Cash and cash equivalents | 2 | ||||
Streeterville LLC [Member] | |||||
Debt Instrument [Line Items] | |||||
Cash and cash equivalents | $ 2.2 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 3 Months Ended | ||||
Mar. 24, 2024 | May 24, 2021 | Mar. 31, 2024 $ / shares shares | Mar. 31, 2023 shares | Dec. 31, 2023 $ / shares | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 0.1 | 0.1 | |||
Fractional Shares issued, Reverse Stock Split | 0 | ||||
Merger agreement | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 0.316 | ||||
Employee Stock Option | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 175,437 | 254,885 | |||
Restricted stock awards | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 66,666 | 100,000 | |||
Common stock warrants | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,034,337 | 3,321,499 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Prepaid Expenses and Other Current Assets | ||
Prepaid clinical development costs | $ 823 | $ 871 |
Prepaid insurance | 638 | 1,078 |
Other prepaid expense | 433 | 334 |
Other current assets | 128 | |
Other current receivables | 6 | 6 |
Total prepaid expense and other current assets | $ 2,028 | $ 2,289 |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Accrued and other current liabilities: | ||
Professional services | $ 2,766 | $ 2,686 |
Accrued research and development expense | 992 | 1,112 |
Accrued employee costs | 959 | 835 |
Other accrued expense | 579 | 81 |
Total accrued and other current liabilities | $ 5,296 | $ 4,714 |
Alvogen Licensing Agreement (De
Alvogen Licensing Agreement (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||
Jun. 02, 2023 | Mar. 31, 2024 | Feb. 28, 2024 | Dec. 31, 2023 | |
Alvogen Licensing Agreement. | ||||
Warrants exercised | 270,000 | |||
Warrants, exercise price per share | $ 19.61 | $ 3.80 | $ 23.01 | |
Warrants issued pursuant to the Alvogen Agreement amendment | $ 1,336 | |||
NRX-101 | License Agreement | Alvogen | ||||
Alvogen Licensing Agreement. | ||||
Initial term | 20 years | |||
Renewal term | 2 years | |||
Period for prior written notice on termination | 60 days | |||
Accelerated Amount | $ 5,000 | |||
First initial payment | $ 4,000 | |||
Warrants exercised | 419,598 | |||
Warrants, exercise price per share | $ 4 | |||
Warrants expiration term | 3 years | |||
Warrants issued pursuant to the Alvogen Agreement amendment | $ 1,300 | |||
Initial Cash Payment To Be Received, Accelerated Amount | $ 5,000 | |||
Refund liability | $ 500 | |||
Equity royalty payable period in case of reversion license | 30 days | |||
First milestone payment to be received | $ 9,000 | |||
Second milestone payment receivable | 5,000 | |||
Maximum bonus milestone payment receivable | $ 315,000 |
Debt - Convertible Note (Detail
Debt - Convertible Note (Details) | 3 Months Ended | |||||||||
Feb. 12, 2024 USD ($) | Feb. 09, 2024 USD ($) | Jul. 07, 2023 USD ($) | May 01, 2023 USD ($) D | Nov. 04, 2022 USD ($) D | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | Mar. 30, 2023 | Dec. 31, 2022 USD ($) | |
Fair value adjustment through earnings | $ (318,000) | $ (1,772,000) | ||||||||
Default Trigger Events [Member] | ||||||||||
Interest rate percentage | 18% | |||||||||
Number of trading days | 5 | |||||||||
Promissory Note 9% Redeemable [Member] | ||||||||||
Interest rate percentage | 9% | |||||||||
Debt Instrument, Face Amount | $ 11,000,000 | |||||||||
Maturity term | 18 months | |||||||||
Original issue discount | $ 1,000,000 | |||||||||
Net proceeds from issuance of notes | $ 10,000,000 | |||||||||
Amount payable on prepayment of notes as a percentage of the principal, interest, and fees owed | 110% | |||||||||
Maximum outstanding balance of the Note that can be redeemed by the holder per month | $ 1,000,000 | |||||||||
Percentage of premium payable on amount redeemed if the notes are redeemed in cash | 10% | |||||||||
Redemption Conversion Price as a percentage of average lowest daily volume weighted average prices per share of the common stock | 85% | |||||||||
Redemption Conversion Price, Number of lowest daily volume weighted average prices per share of the common stock considered | D | 2 | |||||||||
Redemption Conversion Price, Number of trading days considered | D | 10 | |||||||||
Minimum percentage of daily dollar trading volume of the common stock considered to trigger redemption of Notes | 50% | |||||||||
Number of previous trading days over which the median daily dollar trading volume is considered to trigger redemption of Notes | D | 10 | |||||||||
Minimum percentage by which the closing trade price exceeds the Nasdaq Minimum Price, considered to trigger redemption of Notes | 30% | |||||||||
Number of following trading days over which the closing trade price is considered to trigger redemption of Notes | D | 10 | |||||||||
Monthly redemption amount | $ 1,000,000 | |||||||||
Maximum percentage of Common Stock outstanding | 9.99% | |||||||||
Debt discount | $ 1,000,000 | |||||||||
Fair value adjustment through earnings | $ 300,000 | $ 1,700,000 | ||||||||
Cash interest repayments made | 100,000 | |||||||||
Payment of redemption premium | 200,000 | |||||||||
Shares of common stock issued as interest repayment | 100,000 | |||||||||
Cash principal repayments made | 2,200,000 | |||||||||
Shares of common stock issued as principal repayment | 300,000 | |||||||||
Convertible debt | $ 5,400,000 | $ 8,300,000 | ||||||||
Promissory Note 9% Redeemable [Member] | Amendment Two [Member] | ||||||||||
Amount agreed to pay in cash to amend the redemption provisions | $ 1,800,000 | |||||||||
Minimum Payment | 400,000 | |||||||||
Maximum monthly redemption amount per month | $ 1,000,000 | |||||||||
Promissory Note 9% Redeemable [Member] | Amendment Three [Member] | ||||||||||
Amount agreed to pay in cash to amend the redemption provisions | $ 1,100,000 | |||||||||
Minimum Payment | $ 400,000 | |||||||||
Maximum monthly redemption amount per month | $ 400,000 |
Commitments and Contingencies -
Commitments and Contingencies - SHMH License Agreement (Details) | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Commitments and Contingencies | |
Percentage Of certain circumstances | 25% |
SHMH license agreement | |
Commitments and Contingencies | |
Milestone payments annual revenues reach | $ 100,000,000 |
SHMH license agreement | End of Phase I Clinical Trials of Licensed Product | |
Commitments and Contingencies | |
Milestone payments | 100,000 |
SHMH license agreement | End Of Phase II Clinical Trials Of Licensed Product | |
Commitments and Contingencies | |
Milestone payments | 250,000 |
SHMH license agreement | End of Phase III Clinical Trials of Licensed Product | |
Commitments and Contingencies | |
Milestone payments | 250,000 |
SHMH license agreement | First Commercial Sale of Licensed Product in U.S. | |
Commitments and Contingencies | |
Milestone payments | 500,000 |
SHMH license agreement | First Commercial Sale of Licensed Product in Europe | |
Commitments and Contingencies | |
Milestone payments | 500,000 |
SHMH license agreement | Annual Revenues Reach $100,000,000 | |
Commitments and Contingencies | |
Milestone payments | $ 750,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Royalties & Annual Maintenance Fee (Details) - SHMH license agreement | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Commitments and Contingencies | |
Payments for fixed annual maintenance fee | $ 100,000 |
Payments for fixed annual maintenance fee thereafter | $ 150,000 |
License | |
Commitments and Contingencies | |
Percentage of revenue from sale of product not covered by valid claim | 1% |
Percentage of revenue from sale of product covered by valid claim | 2.50% |
Percentage of payment received from sub license in sale | 8.50% |
Commitments and Contingencies_3
Commitments and Contingencies - Exclusive License Agreement (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Commitments and Contingencies | ||
Operating Cost and Expense, Related Party, Type [Extensible Enumeration] | Research and development | Research and development |
Nonrelated Party | ||
Commitments and Contingencies | ||
Worth expenses relating to the relicense of the patent | $ 200,000 | |
Apkarian Technologies | ||
Commitments and Contingencies | ||
Contractual obligation | $ 8,653,120 | |
Worth expenses relating to the relicense of the patent | $ 0 |
Commitments and Contingencies_4
Commitments and Contingencies - Operating Lease (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Maximum | ||
Commitments and Contingencies | ||
Operating Lease, Expense | $ 0.1 | $ 0.1 |
Commitments and Contingencies_5
Commitments and Contingencies - Relief Therapeutics Collaboration Agreement (Details) - Relief Therapeutics Collaboration Agreement - Relief Therapeutics Lawsuit - Relief Therapeutics Holdings, AG $ in Millions | Sep. 18, 2020 USD ($) |
Related Party Transaction [Line Items] | |
Milestone payments receivable | $ 13 |
Royalty payments receivable | 30 |
Indemnity claims | 0.5 |
Maximum | |
Related Party Transaction [Line Items] | |
Representations and Warranties | 2 |
Covenants and Other Agreements | $ 3 |
Equity - Common and Preferred S
Equity - Common and Preferred Stock (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |||||||||||||||
Apr. 01, 2024 shares | Mar. 31, 2024 $ / shares shares | Mar. 24, 2024 | Mar. 21, 2024 shares | Mar. 11, 2024 USD ($) $ / shares | Mar. 05, 2024 USD ($) $ / shares shares | Feb. 29, 2024 $ / shares shares | Feb. 28, 2024 $ / shares shares | Feb. 27, 2024 USD ($) $ / shares shares | Jan. 02, 2024 USD ($) shares | Mar. 11, 2024 $ / shares shares | Feb. 29, 2024 USD ($) $ / shares shares | Aug. 31, 2023 USD ($) shares | Mar. 31, 2024 $ / shares shares | Mar. 31, 2023 shares | Mar. 28, 2024 $ / shares shares | Dec. 31, 2023 $ / shares shares | |
Class of Stock [Line Items] | |||||||||||||||||
Common stock, shares authorized | 500,000,000 | 500,000,000 | 500,000,000 | ||||||||||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||
Warrants, exercise price per share | $ / shares | $ 19.61 | $ 3.80 | $ 19.61 | $ 23.01 | |||||||||||||
Preferred stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | ||||||||||||||
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||
Number of shares issued | 3,750 | 270,000 | |||||||||||||||
Exchange Ratio | 0.1 | 0.1 | |||||||||||||||
Number of issued and outstanding common stock | 1 | 10 | |||||||||||||||
Number of share converted | 1 | ||||||||||||||||
Common stock, shares issued | 9,600,000 | 9,772,672 | 143,648 | 9,772,672 | 95,700,000 | 8,391,940 | |||||||||||
Common stock, shares outstanding | 9,600,000 | 9,772,672 | 9,772,672 | 95,700,000 | 8,391,940 | ||||||||||||
Granted (in shares) | 0 | 0 | |||||||||||||||
Number of fractional shares | 0 | ||||||||||||||||
Number of receive a fractional share | 1 | ||||||||||||||||
Warrants exercised | 270,000 | ||||||||||||||||
Amendment | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Number of issued and outstanding common stock | 10 | ||||||||||||||||
Second amendment | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Preferred stock, shares authorized | 50,000,000 | ||||||||||||||||
Preferred stock, par value | $ / shares | $ 0.001 | ||||||||||||||||
Preferred Stock, Shares Issued | 3,000,000 | ||||||||||||||||
Series A Convertible Preferred Stock | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Preferred stock, shares authorized | 12,000,000 | 12,000,000 | 12,000,000 | ||||||||||||||
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||
Preferred stock, shares outstanding | 0 | 0 | 3,000,000 | ||||||||||||||
Preferred Stock, Shares Issued | 0 | 0 | 3,000,000 | ||||||||||||||
Series A Convertible Preferred Stock | Second amendment | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Preferred stock, shares authorized | 300,000 | 300,000 | 12,000,000 | ||||||||||||||
Preferred stock, shares outstanding | 0 | 0 | |||||||||||||||
Preferred Stock, Shares Issued | 0 | 0 | |||||||||||||||
Aggregate cash purchase price | $ | $ 1,200 | ||||||||||||||||
Shares issued upon conversion | 3,000,000 | 3,000,000 | |||||||||||||||
Minimum | Streeterville Note | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Repayments of Debt | $ | $ 400 | ||||||||||||||||
Securities Purchase Agreement | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Warrants, exercise price per share | $ / shares | $ 3.80 | $ 3.80 | |||||||||||||||
Sale of stock per share | $ / shares | $ 3.80 | $ 3.80 | |||||||||||||||
Number of shares accredited investors purchased | 270,000 | ||||||||||||||||
Warrants exercised | 270,000 | 270,000 | |||||||||||||||
ATM Purchase Agreement | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Number of shares accredited investors purchased | 34,584 | ||||||||||||||||
Consideration received on transaction | $ | $ 200 | ||||||||||||||||
ATM Purchase Agreement | Maximum | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Sale of stock per share | $ / shares | $ 7.10 | $ 7.10 | |||||||||||||||
ATM Purchase Agreement | Minimum | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Sale of stock per share | $ / shares | $ 4.643 | $ 4.643 | |||||||||||||||
Underwritten Public Offering | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Shares Issued, Price Per Share | $ / shares | $ 3 | ||||||||||||||||
Number of shares issued | 500,000 | ||||||||||||||||
February 2024 Public Offering | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Percentage of premium offering price | 26.70% | ||||||||||||||||
Consideration received on transaction | $ | $ 1,000 | ||||||||||||||||
February Underwriting Agreement | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Shares Issued, Price Per Share | $ / shares | $ 2.76 | ||||||||||||||||
Over-Allotment Option | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Less: transaction costs and advisory fees allocated to NRXP equity | $ | $ 400 | ||||||||||||||||
Consideration received on transaction | $ | $ 1,300 | ||||||||||||||||
Purchase additional term | 45 days | ||||||||||||||||
Granted (in shares) | 75,000 | ||||||||||||||||
Warrants exercised | 25,000 | ||||||||||||||||
EF Hutton LLC | |||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||
Common stock, par value | $ / shares | $ 3 | ||||||||||||||||
Less: transaction costs and advisory fees allocated to NRXP equity | $ | $ 200 | ||||||||||||||||
Number of shares issued | 75,000 | ||||||||||||||||
Proceeds from offering | $ | $ 200 |
Equity - Substitute Warrants (D
Equity - Substitute Warrants (Details) $ in Thousands | 3 Months Ended | |||||
Mar. 24, 2024 | May 24, 2021 shares | Mar. 31, 2024 USD ($) shares | Mar. 31, 2023 USD ($) | Feb. 28, 2024 shares | Dec. 31, 2023 shares | |
Class of Stock [Line Items] | ||||||
Exchange Ratio | 0.1 | 0.1 | ||||
Warrants exercised | 270,000 | |||||
Change in fair value of warrant liabilities | $ | $ 9 | $ (12) | ||||
Number of outstanding right | 4,034,337 | 3,321,499 | ||||
Warrants outstanding Unissued | 3,792,970 | |||||
Merger agreement | ||||||
Class of Stock [Line Items] | ||||||
Exchange Ratio | 0.316 | |||||
Merger agreement | Stockholders of NeuroRx | ||||||
Class of Stock [Line Items] | ||||||
Exchange Ratio | 0.316 | |||||
Substitute Warrants | Maximum | ||||||
Class of Stock [Line Items] | ||||||
Change in fair value of warrant liabilities | $ | $ 100 | $ 100 |
Equity - Assumed Public Warrant
Equity - Assumed Public Warrants (Details) - $ / shares | 3 Months Ended | |||||
Mar. 31, 2024 | Mar. 31, 2023 | Feb. 28, 2024 | Dec. 31, 2023 | May 24, 2021 | May 23, 2021 | |
Class of Stock [Line Items] | ||||||
Number of outstanding warrants | 4,034,337 | 3,321,499 | ||||
Warrants exercised | 270,000 | |||||
Warrants, exercise price per share | $ 19.61 | $ 3.80 | $ 23.01 | |||
Public Warrants | ||||||
Class of Stock [Line Items] | ||||||
Number of outstanding warrants | 3,448,856 | 3,448,856 | 3,450,000 | |||
Warrants exercised | 344,886 | 344,886 | 345,000 | |||
Number of shares per warrant | 1 | |||||
Warrants, exercise price per share | $ 115 | |||||
Warrants expiration term | 5 years | |||||
Warrants exercised during period | 0 | 0 |
Equity - Assumed Placement Warr
Equity - Assumed Placement Warrants (Details) - USD ($) $ in Thousands | 3 Months Ended | ||||
Mar. 31, 2024 | Mar. 31, 2023 | Feb. 28, 2024 | Dec. 31, 2023 | May 23, 2021 | |
Class of Stock [Line Items] | |||||
Number of outstanding warrants | 4,034,337 | 3,321,499 | |||
Warrants exercised | 270,000 | ||||
Change in fair value of warrant liability | $ (9) | $ 12 | |||
Placement Warrants | |||||
Class of Stock [Line Items] | |||||
Number of outstanding warrants | 136,250 | ||||
Warrants exercised | 13,625 | ||||
Placement Warrants | Maximum | |||||
Class of Stock [Line Items] | |||||
Change in fair value of warrant liability | $ (100) | $ (100) |
Equity - Investor Warrants (Det
Equity - Investor Warrants (Details) $ / shares in Units, $ in Millions | Mar. 05, 2024 USD ($) shares | Feb. 28, 2024 USD ($) $ / shares shares | Feb. 07, 2024 USD ($) $ / shares shares | Mar. 31, 2024 $ / shares | Feb. 29, 2024 $ / shares shares | Dec. 31, 2023 $ / shares |
Class of Warrant or Right [Line Items] | ||||||
Warrants exercised | 270,000 | |||||
Warrants, exercise price per share | $ / shares | $ 3.80 | $ 19.61 | $ 23.01 | |||
Number of shares issued | 3,750 | 270,000 | ||||
Warrant exercisable term from date of issuance | 6 months | |||||
Warrant maturity term from date of issuance | 5 years | |||||
Change to additional paid-in capital | $ | $ 0.5 | |||||
Stock price on valuation date | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 3.59 | |||||
Exercise price per share | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 3.80 | |||||
Expected life | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 5 | |||||
Volatility | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 178.10 | |||||
Risk-free rate | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 4.26 | |||||
Dividend yield | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 0 | |||||
Securities Purchase Agreement | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants exercised | 270,000 | |||||
Warrants, exercise price per share | $ / shares | $ 3.80 | |||||
Over-Allotment Option | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants exercised | 25,000 | |||||
Warrant exercisable term from date of issuance | 6 months | |||||
Warrant maturity term from date of issuance | 5 years | |||||
Change to additional paid-in capital | $ | $ 0.1 | |||||
Over-Allotment Option | Stock price on valuation date | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 3.05 | |||||
Over-Allotment Option | Exercise price per share | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 3.30 | |||||
Over-Allotment Option | Expected life | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 5 | |||||
Over-Allotment Option | Volatility | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 178.10 | |||||
Over-Allotment Option | Risk-free rate | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 4.26 | |||||
Over-Allotment Option | Dividend yield | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 0 | |||||
February 2024 Over-Allotment Option | ||||||
Class of Warrant or Right [Line Items] | ||||||
Change to additional paid-in capital | $ | $ 0.1 | |||||
February 2024 Over-Allotment Option | Stock price on valuation date | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 3.05 | |||||
February 2024 Over-Allotment Option | Exercise price per share | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 3.30 | |||||
February 2024 Over-Allotment Option | Expected life | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 5 | |||||
February 2024 Over-Allotment Option | Volatility | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 178.10 | |||||
February 2024 Over-Allotment Option | Risk-free rate | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 4.12 | |||||
February 2024 Over-Allotment Option | Dividend yield | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 0 | |||||
Alvogen Licensing Agreement | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants exercised | 419,598 | |||||
Warrants, exercise price per share | $ / shares | $ 4 | |||||
Warrant maturity term from date of issuance | 3 years | |||||
Change to additional paid-in capital | $ | $ 1.3 | |||||
Percentage of beneficial ownership limitation of post exercise | 4.99% | |||||
Percentage of beneficial ownership limitation may be waived up to a maximum | 9.99% | |||||
Alvogen Licensing Agreement | Stock price on valuation date | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 4.10 | |||||
Alvogen Licensing Agreement | Exercise price per share | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 4 | |||||
Alvogen Licensing Agreement | Expected life | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 3 | |||||
Alvogen Licensing Agreement | Volatility | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 138 | |||||
Alvogen Licensing Agreement | Risk-free rate | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 4.2 | |||||
Alvogen Licensing Agreement | Dividend yield | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants and rights outstanding, measurement input | 0 |
Equity - Schedule of Warrant Ac
Equity - Schedule of Warrant Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Total Warrants | ||
Outstanding at the beginning | 3,321,499 | |
Issued | 718,348 | |
Expired | (5,510) | |
Outstanding at the end | 4,034,337 | 3,321,499 |
Weighted Average Remaining Term | ||
Outstanding | 3 years 8 months 4 days | 3 years 10 months 28 days |
Weighted Average Exercise Price | ||
Outstanding at the beginning (in dollars per share) | $ 23.01 | |
Outstanding at the end (in dollars per share) | $ 19.61 | $ 23.01 |
Aggregate Intrinsic Value | ||
Outstanding at the beginning (in dollars) | $ 180 | |
Outstanding at the end (in dollars) | $ 807 | $ 180 |
Stock-Based Compensation - 2016
Stock-Based Compensation - 2016 Omnibus Incentive Plan (Details) | 3 Months Ended | |||
Mar. 24, 2024 | May 24, 2021 $ / shares shares | Mar. 31, 2024 $ / shares shares | Dec. 31, 2023 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exchange Ratio | 0.1 | 0.1 | ||
Options to purchase shares of common Stock | 175,437 | 264,983 | ||
Exercise price | $ / shares | $ 18.60 | $ 18.30 | ||
Merger agreement | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Exchange Ratio | 0.316 | |||
Options to purchase shares of common Stock | 289,542 | |||
Exercise price | $ / shares | $ 51 | |||
2016 Omnibus Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares authorized for issuance | 347,200 |
Stock-Based Compensation - 2021
Stock-Based Compensation - 2021 Omnibus Incentive Plan (Details) - 2021 Omnibus Incentive Plan - shares | 3 Months Ended | |
Jan. 01, 2023 | Mar. 31, 2024 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized for issuance | 955,281 | |
Number of additional shares authorized | 66,443 | |
Percentage of outstanding shares for determination of annual additional shares authorization | 1% | |
Increase in number of shares available for grant | 200,000 | |
Share-based compensation arrangement by share-based payment award number of shares issued upon exercise | 100% | |
Number of shares awarded | 602,365 | |
Number of shares available for issuance | 352,916 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Option Awards, assumptions (Details) | 3 Months Ended |
Mar. 31, 2024 | |
Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Dividend yield | 0% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Number of shares | |||
Outstanding at the beginning (in shares) | 264,983 | ||
Granted (in shares) | 0 | 0 | |
Expired/Forfeited | (89,546) | ||
Outstanding at the end (in shares) | 175,437 | 264,983 | |
Options vested and exercisable (in shares) | 105,215 | ||
Weighted average exercise price | |||
Outstanding at the beginning (in dollars per share) | $ 18.30 | ||
Outstanding at the end (in dollars per share) | 18.60 | $ 18.30 | |
Options vested and exercisable (in dollars per share) | $ 27.61 | ||
Weighted average remaining remaining term (in years) | |||
Outstanding (in years) | 8 years 4 months 24 days | 7 years 8 months 12 days | |
Options vested and exercisable (in years) | 7 years 7 months 6 days | ||
Aggregate intrinsic value | |||
Outstanding at the beginning (in dollars) | $ 75 | ||
Outstanding at the end (in dollars) | 40 | $ 75 | |
Options vested and exercisable | $ 1 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Options (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 242 | $ 695 |
Unrecognized compensation | $ 300 | |
Weighted-average period | 1 year 1 month 6 days | |
Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 100 | $ 700 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted stock (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||
Dec. 28, 2023 | Jul. 12, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||||
Unrecognized compensation | $ 300 | |||
Weighted-average period | 1 year 1 month 6 days | |||
Stock-based compensation expense | $ 242 | $ 695 | ||
Restricted stock awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||||
Balance, beginning of period | 124,166 | |||
Shares granted | 57,500 | 100,000 | ||
Shares vested | 57,500 | |||
Balance, end of period | 66,666 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||||
Grant date fair value, beginning of period | $ 5.20 | |||
Grant date fair value, granted | $ 4.60 | |||
Grant date fair value, vested | 4.64 | |||
End of period | $ 5.66 | |||
Vesting period | 6 years | 3 years | ||
Equity instruments other than options, granted | $ 300 | |||
Unrecognized compensation | $ 200 | |||
Weighted-average period | 1 year 3 months 18 days | |||
Stock-based compensation expense | $ 200 | $ 100 |
Stock-Based Compensation - Reco
Stock-Based Compensation - Recognition of stock-based compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 242 | $ 695 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 211 | 591 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 31 | $ 104 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Liabilities: | ||
Warrant liabilities | $ 26 | $ 17 |
Recurring basis | Level 1 | ||
Assets: | ||
Money Market Account | 566 | 3,874 |
Recurring basis | Level 3 | ||
Liabilities: | ||
Warrant liabilities | 26 | 17 |
Convertible note payable (Note 7) | $ 6,779 | $ 9,161 |
Fair Value Measurements - Conve
Fair Value Measurements - Convertible Note Liability (Details) | Mar. 31, 2024 $ / shares Y | Feb. 28, 2024 | Mar. 31, 2023 Y $ / shares |
Stock price on valuation date | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 3.59 | ||
Risk-free rate | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 4.26 | ||
Recurring basis | Level 3 | Stock price on valuation date | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 4.70 | 6.60 | |
Recurring basis | Level 3 | Risk-free rate | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 0.0456 | 0.0477 | |
Recurring basis | Level 3 | Convertible notes payable | Stock price on valuation date | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 4.70 | 6.60 | |
Recurring basis | Level 3 | Convertible notes payable | Time to expiration | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | Y | 0.42 | 1.09 | |
Recurring basis | Level 3 | Convertible notes payable | Note market interest rate | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 0.165 | 0.171 | |
Recurring basis | Level 3 | Convertible notes payable | Equity volatility | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 1.350 | 1.250 | |
Recurring basis | Level 3 | Convertible notes payable | Volume volatility | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 5.75 | 4.20 | |
Recurring basis | Level 3 | Convertible notes payable | Risk-free rate | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 0.0540 | 0.0458 | |
Recurring basis | Level 3 | Convertible notes payable | Probability of default | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 0.142 | 0.146 |
Fair Value Measurements - Con_2
Fair Value Measurements - Convertible Note Payable (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Change in fair value of convertible note payable | $ 318 | $ 1,772 |
Convertible notes payable | Level 3 | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Fair Value of Note-Beginning Balance | 9,161 | 10,525 |
Conversions and repayments of principal and interest (shares and cash) | (2,700) | |
Change in fair value of convertible note payable | 318 | 1,770 |
Fair value adjustment through accumulated other comprehensive loss | (106) | |
Fair Value of Note-Ending Balance | 6,779 | 12,189 |
Convertible note payable - current portion | $ 6,779 | $ 12,189 |
Fair Value Measurements -Schedu
Fair Value Measurements -Schedule of Measure the warrant liabilities (Details) | Mar. 31, 2024 $ / shares Y | Feb. 28, 2024 | Mar. 31, 2023 Y $ / shares |
Stock price on valuation date | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 3.59 | ||
Exercise price per share | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 3.80 | ||
Expected life | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 5 | ||
Volatility | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 178.10 | ||
Risk-free rate | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 4.26 | ||
Dividend yield | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 0 | ||
Recurring basis | Level 3 | Stock price on valuation date | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | $ / shares | 4.70 | 6.60 | |
Recurring basis | Level 3 | Exercise price per share | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | Y | 115 | 115 | |
Recurring basis | Level 3 | Expected life | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | Y | 2.15 | 3.15 | |
Recurring basis | Level 3 | Volatility | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 1.781 | 1.236 | |
Recurring basis | Level 3 | Risk-free rate | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 0.0456 | 0.0477 | |
Recurring basis | Level 3 | Dividend yield | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | 0 | 0 | |
Recurring basis | Level 3 | Fair value of warrants | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrants and rights outstanding, measurement input | $ / shares | 1.90 | 1.90 |
Fair Value Measurements - Recon
Fair Value Measurements - Reconciliation of warrant liabilities (Details) - Common stock warrants - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Balance at the beginning | $ 17 | $ 37 |
Gain/Loss upon re-measurement | 9 | (12) |
Balance at the end | $ 26 | $ 25 |
Income Taxes (Details)
Income Taxes (Details) | 3 Months Ended | |
Mar. 31, 2024 USD ($) item | Mar. 31, 2023 USD ($) | |
Income Taxes | ||
Income tax benefits | $ | $ 0 | $ 0 |
Tax audits | item | 0 |
Related Party Transactions (Det
Related Party Transactions (Details) | 3 Months Ended | ||||
Mar. 29, 2023 USD ($) shares | Nov. 06, 2022 USD ($) D | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Related Party Transaction [Line Items] | |||||
Minimum equity required for transfer of Excluded Technology | $ 50,000,000 | ||||
Number of consecutive trading days | D | 20 | ||||
Number of trading days | D | 20 | ||||
Threshold aggregate liquidity of the related party | $ 600,000 | ||||
Consulting fee payable per month | 100,000 | ||||
Performance based annual bonus minimum target | $ 300,000 | ||||
2016 Omnibus Incentive Plan | |||||
Related Party Transaction [Line Items] | |||||
Shares granted | shares | 50,000 | ||||
Number of shares, restrictions removed on new drug application date | shares | (25,000) | ||||
Number of shares, restrictions removed on new drug approval date | shares | (25,000) | ||||
Former CEO | |||||
Related Party Transaction [Line Items] | |||||
Payment to related party | $ 200,000 | $ 300,000 | |||
Chief Executive Officer Son [Member] | |||||
Related Party Transaction [Line Items] | |||||
Payment to related party | 100,000 | 100,000 | |||
Related Party [Member] | Maximum | |||||
Related Party Transaction [Line Items] | |||||
Accounts payable due to related parties | 100,000 | $ 100,000 | |||
Glytech Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Payment to related party | $ 0 | $ 100,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||||||
Apr. 24, 2024 | Apr. 19, 2024 | Apr. 18, 2024 | Apr. 15, 2024 | Apr. 01, 2024 | Mar. 31, 2024 | Apr. 30, 2024 | Mar. 31, 2024 | Feb. 28, 2024 | Dec. 31, 2023 | |
Subsequent Event [Line Items] | ||||||||||
Fractional Shares issued, Reverse Stock Split | 0 | |||||||||
Number of issued and outstanding common stock | 1 | 10 | ||||||||
Warrants, exercise price per share | $ 19.61 | $ 19.61 | $ 3.80 | $ 23.01 | ||||||
Warrants exercised | 270,000 | |||||||||
At-the-market offering | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Common stock issued | $ 179 | |||||||||
Underwriting discounts and commissions | $ 48 | |||||||||
Over-Allotment Option | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Warrants exercised | 25,000 | |||||||||
Subsequent Event [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Fractional Shares issued, Reverse Stock Split | 0 | |||||||||
Number of issued and outstanding common stock | 73,040 | |||||||||
Subsequent Event [Member] | Minimum | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Damages sought | $ 6,500 | |||||||||
Subsequent Event [Member] | At-the-market offering | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Common stock issued | $ 1,000 | $ 1,300 | ||||||||
Offering agreement for an aggregate | $ 4,900 | |||||||||
Subsequent Event [Member] | April 2024 Underwritten Public Offering | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Underwritten public offering | 607,000 | |||||||||
Share price | $ 3.30 | |||||||||
Purchase price | $ 3 | |||||||||
Over Allotment Option Period | 45 days | |||||||||
Aggregate gross proceeds from the Offering | $ 2,000 | |||||||||
Underwriting discounts and commissions | $ 300 | |||||||||
Percentage of shares issuable | 5% | |||||||||
Subsequent Event [Member] | April 2024 Underwritten Public Offering | Underwriters warrants | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Warrants, exercise price per share | $ 3.63 | |||||||||
Warrants exercised | 30,350 | |||||||||
Period for exercise of warrants | 6 months | |||||||||
Period for expiration of warrants | 5 years | |||||||||
Subsequent Event [Member] | Over-Allotment Option | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Underwritten public offering | 91,050 | |||||||||
Subsequent Event [Member] | Over-Allotment Option | Underwriters warrants | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Warrants exercised | 4,553 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (6,528) | $ (11,039) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |