You should read the following discussion and analysis ofNRx Pharmaceuticals' financial condition and plan of operations together withNRx Pharmaceuticals' unaudited, condensed consolidated financial statements and the related notes appearing elsewhere herein. In addition to historical information, this discussion and analysis contains forward looking statements that involve risks, uncertainties and assumptions.NRx Pharmaceuticals' actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section entitled "Risk Factors" included elsewhere herein.
Overview
OnMay 24, 2021 ,Big Rock Partners Acquisition Group ("BRPA"), a special purpose acquisition company, consummated the Agreement and Plan of Merger (as amended, the "Merger Agreement") withNeuroRx, Inc. , aDelaware corporation ("NeuroRx"), andBig Rock Merger Corp. , aDelaware corporation and wholly-owned, direct subsidiary of BRPA ("Merger Sub"). Pursuant to the Merger Agreement, onMay 24, 2021 (the "Closing Date"), which has been accounted for as a reverse recapitalization, Merger Sub was merged with and intoNeuroRx , withNeuroRx surviving the merger (the "Merger" and, together with the other transactions contemplated by the Merger Agreement, the "Business Combination"). On the Closing Date, BRPA changed its name toNRX Pharmaceuticals, Inc. ("NRx Pharmaceuticals " or the "Company").NRx Pharmaceuticals is a clinical stage pharmaceutical company that is developing, through its wholly-owned operating subsidiary,NeuroRx , NRX-100 and NRX-101, the first oral therapeutic for the treatment of Bipolar Depression in patients with Acute Suicidal Ideation and Behavior (ASIB) and Sub-Acute Suicidal Ideation and Behavior ("SSIB"), and ZYESAMI® (aviptadil), an intravenous and inhaled drug to treat respiratory failure in COVID-19 and potentially other respiratory disorders. NRX-100 and NRX-101 were developed based upon 30 years of basic science and clinical expertise contributed by Dr.Daniel Javitt , MD, PhD, related to the role of the brain's N-methyl-D-aspartate ("NMDA") receptor in regulating human thought processes in general and in regulating depression and suicidality. The NRX-100 and NRX-101 therapy begins with a single dose of ketamine (NRX-100), aFood & Drug Administration ("FDA") approved anesthetic, followed by approximately six weeks of daily oral NRX-101. NRX-101 is being developed as a rapid-onset and sustained treatment for bipolar depression with ASIB and SSIB. NRX-101 combines d-Cycloserine, a NMDA receptor modulator, and lurasidone, a 5-HT2a receptor antagonist. NRX-101 has been awarded Fast Track designation, Breakthrough Therapy designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA. Peer-reviewed and published results from Phase II clinical studies demonstrate a significant decline and stabilization in symptoms of depression and suicidality following administration of DCS. Findings from one of these studies found that bipolar patients who were already receiving a 5-HT2a antagonist demonstrated more than a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation when ketamine and DCS were added to their treatment regimen. Side effects for patients in a P2a combination study of DCS and 5HT2a included mild sedation, headaches and hypomania. Breakthrough Therapy designation was awarded based on data from the STABIL-B study (NCT02974010) that demonstrated a statistically significant advantage of NRX-101 vs. lurasidone (the current standard of care) in maintaining remission from depression and suicidality following a single stabilizing dose of ketamine.NRx Pharmaceuticals initiated a Phase II SSIB clinical study in the second quarter of 2022 for which enrollment has begun. The Company plans to initiate a Phase III registrational ASIB study in the second half of 2022. InMarch 2020 ,NRx Pharmaceuticals initiated development of RLF-100 (aviptadil acetate) (now reformulated as ZYESAMI byNRx Pharmaceuticals ) in partnership with Relief Therapeutics Holding AG ("Relief Therapeutics"). ZYESAMI is based on 50 years of research, pioneered by ProfessorSami Said , on the role of Vasoactive Intestinal Peptide/Aviptadil in preventing and treating acute lung injury by protecting the Type II cell in the lung. The rights toProfessor Said's scientific work are licensed by the Company from theResearch Foundation for the State University of New York .NRx Pharmaceuticals and Relief Therapeutics entered into a collaboration agreement onSeptember 18, 2020 (the "Collaboration Agreement") for the clinical development and, if approved, the sale of Aviptadil. The Collaboration Agreement provided for funding by Relief Therapeutics of certain clinical trials, formulation and manufacturing of Aviptadil, as well as established sales territories for each party and share of the profits in those territories for "Product" as 25 Table of Contents
defined in the Collaboration Agreement. Relief Therapeutics has reimbursed the Company approximately$10.9 million but has subsequently declined to reimburse the Company for additional costs. OnOctober 6, 2021 , Relief Therapeutics filed a complaint inNew York State Court, claiming that the Company failed to honor its obligations under the Collaboration Agreement. Relief Therapeutics' complaint seeks several remedies, including damages for alleged breaches of the terms of the Collaboration Agreement. The Company believes that the claims are baseless and without merit. OnJanuary 10, 2022 , the Company filed a complaint inNew York State Court, claiming Relief Therapeutics breached and repudiated the Collaboration Agreement. The Company's complaint seeks damages of at least$185.0 million . The parties to the lawsuits agreed to engage in mediation in an effort to amicably resolve the litigation. If the mediation does not resolve the dispute, the Company intends to defend itself vigorously and to prosecute its claims against Relief Therapeutics. In an open-label, single center trial atHouston Methodist Hospital , ZYESAMI demonstrated a statistically significant 9-fold advantage in probability of survival and recovery from respiratory failure compared to the standard of care among patients with COVID-19 respiratory failure. OnMarch 29, 2021 ,NRx Pharmaceuticals reported top-line Phase IIb/III study results of ZYESAMI in patients with respiratory failure due to Critical COVID-19. Though it did not meet statistical significance for the pre-specified primary endpoint of "alive and free of respiratory failure" (P=.08), the study identified a two-fold statistically significant odds of survival at day 60 (P=.03), and significant advantages on secondary endpoints, for those treated with ZYESAMI compared to those treated with placebo. On the basis of these results, theNational Institute for Allergy and Infectious Diseases selectedNRx Pharmaceuticals as an industry partner for participation in the ACTIV3b/TESICO trial (NCT 04843761) in which patients with Critical COVID-19 are randomized to aviptadil, remdesivir, and placebo.NRx Pharmaceuticals provides doses of aviptadil as the industry partner and theU.S. Government funds all other costs of research. As ofMarch 2022 , approximately 465 patients with Critical COVID-19 were enrolled and treated with either aviptadil or placebo. The endpoint of the trial is superiority on an ordinal scale that includes survival and recovery from respiratory failure at 90 days. As of theFebruary 25, 2022 the Data Safety and Monitoring Board ("DSMB") meeting, no unexpected adverse events were identified in association with ZYESAMI and the trial was cleared to continue enrolling. To date, the DSMB has not declared futility of the aviptadil arm of the ACTIV-3b trial, although futility has been declared for all other investigational products selected in the ACTIV-3b trial studying Critical COVID-19 patients. The DSMB is scheduled to review the data again onMay 25, 2022 . A previously targeted DSMB meeting for end of April was moved to this new date to allow for the vast majority of enrolled patients to have reached 90 days.NRx Pharmaceuticals applied for FDA Emergency Use Authorization ("EUA") onMay 31, 2021 . InNovember 2021 , the FDA notified us that it was unable to issue the EUA at that time due to insufficient data regarding the known and potential benefits of ZYESAMI and the known and potential risks of ZYESAMI in patients suffering from critical COVID-19 with respiratory failure. InNovember 2021 , the FDA also declined a request for Breakthrough Therapy designation, mentioning in its reply that the request did not adequately compare the safety and efficacy of aviptadil to existing therapies in Critical COVID-19 patients, such as remdesivir. In response, inFebruary 2022 , the Company filed a new request for EUA in patients with COVID-19 respiratory failure who are at immediate risk of death despite treatment with remdesivir and other approved therapies. This new request is based on a post-hoc analysis of the approximately 70% of patients in the randomized study that were also treated with remdesivir and included safety data on approximately 750 patients treated with ZYESAMI in our clinical trials, our Expanded Access Programs, our Right To Try Program and the ACTIV-3b trial. OnApril 20, 2022 , the Company submitted a new Breakthrough Therapy designation request focused on this narrower population of patients that are at immediate risk of death despite treatment with remdesivir. As of the date hereof, these requests are still pending. Should an EUA be granted, this would provideNRx Pharmaceuticals with a one-year period during which ZYESAMI could be marketed for the treatment of COVID-19 inthe United States in advance of the filing a new drug application ("NDA") with the FDA for formal approval of ZYESAMI for the treatment of COVID-19. If authorized for use, we believe ZYESAMI would fill a high unmet need for COVID-19 patients who are critically ill with respiratory failure, as current options have only limited applicability in this patient segment. 26
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Manufacturing and scalability of ZYESAMI are a major focus of the Company. Working with its manufacturing partners, the Company has the capability to produce batch sizes of 1.5kg and potentially larger of the active pharmaceutical ingredient (API) of ZYESAMI. In addition to producing ZYESAMI API at a scale suitable for commercial quantities, the Company has gained insights into how to address the chemical basis for the instability of the formulated drug product ZYESAMI in solution. The Company has now demonstrated a formulation of ZYESAMI with refrigerated stability of up to 8 months and expected multi-year frozen stability (-20°C). InJanuary 2022 , the Company filed a Composition of Matter patent application that describes this extended stability form of aviptadil. In the process, the Company has identified specific aspects of the manufacturing process that it believes are key to preserving the stability of aviptadil for stockpiling and commercial supply chain purposes. OnOctober 8, 2021 , the Company submitted an updated manufacturing module to its FDA Investigational New Drug file documenting this change in manufacture and stability. OnNovember 8, 2021 , the FDA communicated with the Company that the manufacturing update had been reviewed and that no "clinical hold" items had been identified (this is the regulatory language that allows an investigational product to be given to patients). The Company initiated a parallel manufacturing process to conform toEU andUK standards. InOctober 2021 , the Company announced that a European Qualified Person audit was conducted, and no major deficiencies were identified, thus clearing ZYESAMI's use inEU investigational programs. Since inception,NRx Pharmaceuticals has incurred significant operating losses. For the three months endedMarch 31, 2022 and 2021,NRx Pharmaceuticals' net loss was$13.4 million and$25.5 million , respectively. As ofMarch 31, 2022 ,NRx Pharmaceuticals had an accumulated deficit of$196.7 million .
Components of Results of Operations
Operating expenses
Research and development expenses
NRx Pharmaceuticals' research and development expenses consist primarily of costs associated withNRx Pharmaceuticals' clinical trials, salaries, payroll taxes, employee benefits, and equity-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.
General and administrative expenses
General and administrative expense consists primarily of salaries, stock-based compensation, consultant fees, and professional fees for legal and accounting services. Settlement Expense
Settlement expense consists primarily of settlement expenses related to the GEM Warrant. See Note 8 "Commitments and Contingencies - Share Subscription Facility Agreement - GEM" of the notes to the Company's unaudited condensed consolidated financial statements included elsewhere in this report for further information.
Reimbursement of expenses from Relief Therapeutics
Reimbursement of expenses from Relief Therapeutics consists of reimbursable expenses as part of the Collaboration Agreement. See Note 8 "Commitments and Contingencies - Relief Therapeutics Collaboration Agreement" of the notes to the Company's unaudited condensed consolidated financial statements included elsewhere in this report for further information. 27
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Results of operations for the three months ended
The following table sets forth
Three months ended March 31, Change 2022 2021 Dollars (Unaudited) Operating expenses:
Research and development $ 5,483 $ 2,909$ 2,574 General and administrative 10,222 2,101$ 8,121 Settlement expense - 21,366$ (21,366) Reimbursement of expenses from Relief Therapeutics - (771)$ 771 Total operating expenses$ 15,705 $ 25,605 $ (9,900) Loss from operations$ (15,705)
Other (income) expenses: Gain on extinguishment of debt - (121)$ 121 Interest expense 3 5$ (2) Change in fair value of warrant liability (157) -$ (157) Change in fair value of Earnout Cash liability (2,103) -$ (2,103) Total other (income) expenses (2,257)
(116)$ (2,141) Net loss$ (13,448) $ (25,489) $ 12,041 Operating expenses
Research and development expenses
For the three months endedMarch 31, 2022 ,NRx Pharmaceuticals recorded$5.5 million of research and development expenses compared to$2.9 million for the three months endedMarch 31, 2021 . The increase of$2.6 million related primarily to an increase of$2.1 million in clinical trials and development expenses related to ZYESAMI, an increase of$0.2 million in stock-based compensation expense, and an increase of$0.3 million in other regulatory and process development expenses. The$5.5 million and$2.9 million of research and development expenses for the three months endedMarch 31, 2022 and 2021, respectively, include$0.2 million and less than$0.1 million , respectively, of non-cash stock-based compensation.
General and administrative expenses
For the three months endedMarch 31, 2022 ,NRx Pharmaceuticals recorded$10.2 million of general and administrative expenses compared to$2.1 million for the three months endedMarch 31, 2021 . The increase of$8.1 million was primarily, related to an increase of$4.4 million in legal, professional and accounting fees, an increase of$2.2 million in insurance expense, an increase of$0.8 million in stock-based compensation expense, and an increase of$0.7 million in other general and administrative expense. The$10.2 million and$2.1 million of general and administrative expenses for the three months endedMarch 31, 2022 and 2021, respectively, include$1.1 million and$0.3 million , respectively, of non-cash stock-based compensation.
Reimbursement of expenses from Relief Therapeutics
For the three months endedMarch 31, 2022 ,NRx Pharmaceuticals recorded no reimbursement of expenses from Relief Therapeutics compared to$0.8 million of reimbursement of expenses from Relief Therapeutics for the three months endedMarch 31, 2021 . Other (income) expenses 28 Table of Contents
Gain on extinguishment of debt
For the three months endedMarch 31, 2022 ,NRx Pharmaceuticals recorded no gain on extinguishment of debt compared to$0.1 million for the three months endedMarch 31, 2021 . The decrease of$0.1 million related to the forgiveness of the PPP Loan which resulted in a gain on extinguishment for the outstanding principal and accrued and unpaid interest for the three months endedMarch 31, 2021 .
Change in fair value of warrant liability
For the three months endedMarch 31, 2022 ,NRx Pharmaceuticals recorded a gain of$0.2 million related to the change in fair value of the warrant liability. The gain of$0.2 million related to the decrease in the fair value of the Placement Warrants assumed pursuant to the Merger Agreement.
Change in fair value of Earnout Cash liability
For the three months endedMarch 31, 2022 ,NRx Pharmaceuticals recorded a gain of$2.1 million related to the change in fair value of the Earnout Cash liability. The gain related to the decrease in the fair value of the Earnout Cash liability pursuant to the Merger Agreement.
Liquidity and Capital Resources
NRx Pharmaceuticals has generated no revenues, has incurred operating losses since inception, and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. Until such time asNRx Pharmaceuticals is able to establish a revenue stream from the sale of its therapeutic products,NRx Pharmaceuticals is dependent upon obtaining necessary equity and/or debt financing to continue operations.NRx Pharmaceuticals cannot make any assurances that sales of ZYESAMI will commence in the near term or that additional financings will be available to it and, if available, on acceptable terms or at all. This could negatively impactNRx Pharmaceuticals' business and operations and could also lead to the reduction ofNRx Pharmaceuticals' operations.NRx Pharmaceuticals believes that it currently has sufficient funds and, if necessary, the ability to reduce expenditures, to support operations through at least the next twelve months from the date hereof.NRx Pharmaceuticals is dependent upon obtaining necessary equity and/or debt financing to continue operating.NRx Pharmaceuticals cannot make any assurances that additional financing will be available to it and, if available, on acceptable terms or at all. This could negatively affect the Company's business and operations and could also lead to the reduction of the Company's operations.
Private Placement
On
Reverse Recapitalization Merger and Subsequent Equity Issuances
Pursuant to the terms of the Merger Agreement,NeuroRx's securityholders (including option holders and warrant holders) who ownNeuroRx securities immediately prior to the Effective Time will have the contingent right to receive their pro rata portion of (i) an aggregate of 25,000,000 shares of Common Stock ("Earnout Shares") if, prior toDecember 31, 2022 , theNeuroRx COVID-19 Drug (i.e., ZYESAMI) receives emergency use authorization by theFood and Drug Administration ("FDA") andNeuroRx submits and the FDA files for review a new drug application for the NeuroRx COVID-19 Drug (i.e., ZYESAMI) (the occurrence of the foregoing, the "Earnout Shares Milestone"), and (ii) an aggregate of$100.0 million in cash ("Earnout Cash") upon the earlier to occur of (x) FDA approval of the NeuroRx COVID-19 Drug (i.e., ZYESAMI) and the listing of the NeuroRx COVID-19 Drug in theFDA's "Orange Book" and (y) FDA approval of the NeuroRx Antidepressant Drug Regimen (i.e., NRX-100/101) and the listing of the NeuroRx Antidepressant Drug Regimen (i.e., NRX-100/101) in theFDA's "Orange Book," in each case prior toDecember 31, 2022 (the occurrence of either of clauses (x) or (y), the "Earnout Cash Milestone"). If the Earnout Shares Milestone is achieved, the Earnout Shares will be issued within five (5) Business Days after the occurrence of the Earnout Shares Milestone. If the Earnout Cash Milestone is achieved, the Merger Agreement does not require the Earnout Cash to be delivered toNeuroRx securityholders within any specified period of time, and the board of directors ofNRx Pharmaceuticals will use its good faith judgment to determine the date to pay the Earnout Cash. AtMarch 31, 2022 , the fair value of the Earnout Cash liability has been 29
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estimated to be$2.5 million . Upon closing of the Merger, the estimated fair value of the Earnout Shares was$253.1 million with such amount recognized as a deemed dividend. As the Company is in an accumulated deficit position as of the measurement date, the resulting deemed dividend is recorded as a reduction of additional paid-in capital with a corresponding offset recorded to additional paid-in capital (i.e., net impact to additional paid-in capital of$0 ). The benefit of the contingent right to receive Earnout Cash for option and warrant holders occurs through the Option Exchange Ratio and therefore the amount of Earnout Cash for common stockholders is approximately$88.8 million . In connection with the Merger, a number of subscribers (each, a "Subscriber") purchased from the Company an aggregate of 1,000,000 shares of Common Stock (the "PIPE"), for a purchase price of$10.00 per share and an aggregate purchase price of$10.0 million (the "PIPE Shares"), pursuant to separate subscription agreements (each, a "Subscription Agreement") entered into prior to the Closing Date. The Company received$8.1 million in net proceeds after transaction costs from the sale of PIPE Shares. 30 Table of Contents
The following table presents selected financial information and statistics for each of the periods shown below:
March 31, 2022 December 31, 2021 (Unaudited) Balance Sheet Data: Cash $ 40,202 $ 27,605 Total assets 43,601 32,729 Earnout cash liability 2,479 4,582 Total liabilities 11,912 11,923
Total stockholders' equity (deficit) 31,689
20,806March 31, 2022 2021 (Unaudited) Statement of Cash Flow Data:
Net cash used in operating activities$ (10,380) $
(3,015)
Net cash used in investing activities (3)
-
Net cash provided by financing activities 22,980
14,427 Net increase in cash $ 12,597 $ 11,412 Operating activities During the three months endedMarch 31, 2022 , operating activities used$10.4 million of cash, primarily resulting from a net loss of$13.4 million , increased by net non-cash gains of$1.0 million , including$2.1 million of gain from the change in fair value of earn out liability and$0.2 million of gain from the changes in fair value of warrant liability, partially offset by$1.3 million of stock-based compensation expense, and an increase in net operating assets of$4.0 million . During the three months endedMarch 31, 2021 , operating activities used$3.0 million of cash, primarily resulting from a net loss of$25.5 million , reduced by non-cash charges of$21.6 million , including$21.4 million of non-cash settlement expense related to the GEM Warrant,$0.4 million of stock-based compensation expense, partially offset by a gain on extinguishment of debt of$0.1 million ; and an increase in net operating assets of$0.9 million .
Financing activities
During the three months endedMarch 31, 2022 , financing activities provided$23.0 million of cash resulting from the net proceeds received by the Company from the issuance of common stock and preferred investment options in a private placement. During the three months endedMarch 31, 2021 , financing activities provided$14.4 million of cash, primarily resulting from$6.9 million of proceeds from the issuance of shares ofNeuroRx common stock and$7.5 million of the issuance ofNeuroRx common stock for the exercise of the GEM Warrants.
Contractual Obligations and Commitments
See Note 8, Commitments and Contingencies, of the notes toNRx Pharmaceuticals' unaudited condensed consolidated financial statements as of and for the three months ended months endedMarch 31, 2022 included elsewhere in this report for further discussion ofNRx Pharmaceuticals' commitments and contingencies.
Milestone Payments
Pursuant to the legal settlement withSarah Herzog Memorial Hospital Ezrat Nashim ("SHMH") inSeptember 2018 , which included the license of intellectual property rights from SHMH, an ongoing royalty of 1% to 2.5% of NRX-101 gross sales is due to SHMH, together with milestone payments of$0.3 million , upon completion of phase 3 trials and commercial sale of NRX-101. The milestone payments for developmental and commercial milestones range from$0.1 million to$0.8 million . Annual maintenance fees are up to$0.2 million . 31
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Off-Balance Sheet Arrangements
Critical Accounting Policies and Significant Judgments and Estimates
NRx Pharmaceuticals' management's discussion and analysis of its financial condition and results of operations is based on its financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requiresNRx Pharmaceuticals to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the balance sheet and the reported amounts of expenses during the reporting period. In accordance with GAAP,NRx Pharmaceuticals evaluates its estimates and judgments on an ongoing basis. The most significant estimates relate to the Earnout Cash Liability, stock-based compensation, and the valuation of warrants.NRx Pharmaceuticals bases its estimates and assumptions on current facts, historical experiences, and various other factors thatNRx Pharmaceuticals believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.NRx Pharmaceuticals defines its critical accounting policies as those accounting principles that require it to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on its financial condition and results of operations, as well as the specific manner in whichNRx Pharmaceuticals applies those principles. While its significant accounting policies are more fully described in Note 2 to its financial statements,NRx Pharmaceuticals believes the following are the critical accounting policies used in the preparation of its financial statements that require significant estimates and judgments.
Earnout Cash Liability
The fair value of the Earnout Cash liability has been estimated using probability-weighted discounted cash flow models (DCFs) with significant inputs that are not observable in the market and thus represents a Level 3 fair value measurement as defined in ASC 820. The most significant inputs include whether (a) the FDA approves the Company's NDAs for ZYESAMI and/or NRX-101, (b) if such approval is granted, whether such approval will be received on or beforeDecember 31, 2022 , and (c) if such approval is granted, whether ZYESAMI and/or NRX-101 will be listed in theFDA's Orange Book on or beforeDecember 31, 2022 . The DCFs incorporate Level 3 inputs including estimated discount rates that we believe market participants would consider relevant in pricing and the projected timing and amount of cash flows, which are estimated and developed in consideration of the uncertainties associated with the obligations. Changes in the estimated fair value of the Earnout Cash Liability are recognized as a gain or loss in the statements of operations.
Fair value of common and preferred stock
Prior to the Merger, in order to determine the fair value of shares of its common stock, the Company's board of directors considered, among other things, contemporaneous valuations of its common stock and preferred stock based on arms-length transactions with third party investors. Subsequent to the Merger, the Board determines the fair value of the Common Stock based on the closing market price on the date of grant.
Stock-based compensation
We measure stock option awards granted to employees and directors based on the fair value of the award on the date of the grant and recognize compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. The straight-line method of expense recognition is applied to awards with service-only conditions. We account for forfeitures as they occur. We estimate the fair value of each stock option award using the Black-Scholes option-pricing model, which uses as inputs the fair value of our common stock and assumptions we make for the volatility of our common stock, the expected term of our stock-based awards, the risk-free interest rate for a period that approximates the expected term of our stock-based 32
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awards, and our expected dividend yield. Therefore, we estimate our expected volatility based on the implied volatility of publicly traded warrants on our common stock and historical volatility of a set of our publicly traded peer companies. We estimate the expected term of our options using the "simplified" method for awards that qualify as "plain-vanilla" options. The risk-free interest rate is determined by reference to theU.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that we have never paid cash dividends on common stock and do not expect to pay any cash dividends in the foreseeable future. The assumptions used in determining the fair value of stock-based awards represent reasonable estimates, but the estimates involve inherent uncertainties and the application of our judgment. As a result, if factors change and we use significantly different assumptions or estimates, our stock-based compensation expense could be materially different in the future.
Warrant liability
We account for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant's specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity ("ASC 480") and ASC 815, Derivatives and Hedging ("ASC 815"). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company's own common stock and whether the warrant holders could potentially require "net cash settlement" in a circumstance outside of the Company's control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. 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 recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The fair value of the Placement Warrants was estimated using a Black Scholes valuation approach.
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