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Table of Contents



 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarterly Period Ended: June 30, 2024

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from to

 

Commission File Number: 001-38302

 

NRX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

82-2844431

(State or other jurisdiction of

(I.R.S. Employer

incorporation or organization)

Identification No.)

 

1201 Orange Street, Suite 600

Wilmington, DE 19801

(Address of principal executive offices) (Zip Code)

 

(484) 254-6134

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class:

 

Trading Symbol(s)

 

Name of each exchange on which registered:

Common Stock, par value $0.001 per share

 

NRXP

 

The Nasdaq Stock Market LLC

Warrants to purchase Common Stock

 

NRXPW

 

The Nasdaq Stock Market LLC

 

Securities registered pursuant to Section 12(g) of the Act: None

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer

Smaller reporting company
Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No ☒

 

As of August 14, 2024, the registrant had 10,894,693 shares of Common Stock outstanding.

 



 

 

 

 

 

 

Page

PART I - FINANCIAL INFORMATION

 

ITEM 1.

Financial Statements

 
 

Condensed Consolidated Balance Sheets as of June 30, 2024 (Unaudited) and December 31, 2023

3

 

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2024 and 2023

4

 

Unaudited Condensed Consolidated Statements of Changes in Stockholders' Deficit for the three and six months ended June 30, 2024 and 2023

5

 

Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023

6

 

Notes to Unaudited Condensed Consolidated Financial Statements

7

ITEM 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

27

ITEM 3.

Quantitative and Qualitative Disclosures About Market Risk

39

ITEM 4.

Controls and Procedures

39

     

PART II - OTHER INFORMATION

 
     

ITEM 1.

Legal Proceedings

40

ITEM 1A.

Risk Factors

40

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

40

ITEM 3.

Defaults Upon Senior Securities

40

ITEM 4.

Mine Safety Disclosures

40

ITEM 5.

Other Information

40

ITEM 6.

Exhibits

41

SIGNATURES

42

 

 

 

 

 

 

PART I FINANCIAL INFORMATION

 

ITEM 1. Financial Statements

 

NRX PHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

 

 

  

June 30,

  

December 31,

 
  

2024

  

2023

 
  

(Unaudited)

     

ASSETS

        

Current assets:

        

Cash and cash equivalents

 $1,898  $4,595 

Prepaid expense and other current assets

  2,982   2,289 

Total current assets

  4,880   6,884 

Other assets

  384   431 

Total assets

 $5,264  $7,315 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

        

Current liabilities:

        

Accounts payable

 $5,015  $4,632 

Accrued and other current liabilities

  9,594   4,714 

Accrued clinical site costs

  444   524 

Convertible note payable and accrued interest

  7,651   9,161 

Insurance loan payable

  943    

Warrant liabilities

  8   17 

Total liabilities

 $23,655  $19,048 
         

Commitments and Contingencies (Note 8)

          
         

Stockholders’ deficit:

        

Preferred stock, $0.001 par value, 50,000,000 shares authorized.

 $  $ 

Series A convertible preferred stock, $0.001 par value, 12,000,000 shares authorized; 0 and 3,000,000 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively

     3 

Common stock, $0.001 par value, 500,000,000 shares authorized; 10,791,630 and 8,391,940 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively

  11   8 

Additional paid-in capital

  249,173   241,406 

Accumulated other comprehensive loss

  (3)  (3)

Accumulated deficit

  (267,572)  (253,147)

Total stockholders’ deficit

  (18,391)  (11,733)

Total liabilities and stockholders' deficit

 $5,264  $7,315 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 

NRX PHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share data)

(Unaudited)

 

   

Three months ended June 30,

   

Six months ended June 30,

 
   

2024

   

2023

   

2024

   

2023

 

Operating expense:

                               

Research and development

  $ 2,804     $ 3,873     $ 4,552     $ 7,523  

General and administrative

    4,246       4,065       8,496       9,850  

Settlement expense

          250             250  

Total operating expenses

    7,050       8,188       13,048       17,623  

Loss from operations

    (7,050 )     (8,188 )     (13,048 )     (17,623 )

Other (income) expense:

                       

 

 

Interest income

    (7 )     (145 )     (34 )     (301 )

Interest expense

                230        

Convertible note default penalty

    849             849        

Change in fair value of convertible note payable

    23       663       341       2,435  

Change in fair value of warrant liabilities

    (18 )     11       (9 )     (1 )

Total other expense

    847       529       1,377       2,133  

Net loss

  $ (7,897 )   $ (8,717 )   $ (14,425 )   $ (19,756 )

Comprehensive loss:

                               

Change in fair value of convertible note attributed to credit risk

  $     $ 128     $     $ 22  

Other comprehensive loss

          128             22  

Comprehensive loss

  $ (7,897 )   $ (8,845 )   $ (14,425 )   $ (19,778 )

Net loss per share:

                               

Basic and diluted

  $ (0.75 )   $ (1.21 )   $ (1.49 )   $ (2.81 )

Weighted average common shares outstanding:

                               

Basic and diluted

    10,517,460       7,322,156       9,684,873       7,026,062  

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 

NRX PHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS (DEFICIT) EQUITY

(in thousands, except share data)

(Unaudited)

 

                          

Additional

      

Accumulated Other

  

Total

 
  

Preferred Stock

  

Series A Preferred Stock

  

Common Stock

  

Paid-in-

  

Accumulated

  

Comprehensive

  

Stockholders’

 
  

Shares

  

Amount

  

Shares

  

Amount

  

Shares

  

Amount

  

Capital

  

Deficit

  

Loss

  

Deficit

 

Balance December 31, 2023

    $   3,000,000  $3   8,391,940  $8  $241,406  $(253,147) $(3) $(11,733)

Stock-based compensation

                    242         242 

Conversion of Series A preferred stock into common stock

        (3,000,000)  (3)  300,000      3          

At-the-market "ATM" offering, net of offering costs of $48

              34,584      179         179 

Common stock and warrants issued, net of issuance costs of $481

              575,000   1   1,343         1,344 

Common stock and warrants issued in private placement

              270,000      1,027         1,027 

Warrants issued pursuant to the Alvogen Agreement amendment (see Note 6)

                              

Vesting of restricted stock awards

              57,500                

Shares issued as repayment of principal and interest for convertible note

              143,648   1   399         400 

Net loss

                       (6,528)     (6,528)

Balance - March 31, 2024

    $     $   9,772,672  $10  $244,599  $(259,675) $(3) $(15,069)

Stock-based compensation

                    97         97 

ATM offering, net of offering costs of $118

              247,868      1,228         1,228 

Common stock and warrants issued, net of issuance costs of $494

              698,050   1   1,913         1,914 

Issuance of shares related to reverse stock split

              73,040                

Contract cost related to Alvogen termination (see Note 6)

                    1,336         1,336 

Net loss

                       (7,897)     (7,897)

Balance - June 30, 2024

    $     $   10,791,630  $11  $249,173  $(267,572) $(3) $(18,391)

 

                          

Additional

      

Accumulated Other

  

Total

 
  

Preferred Stock

  

Series A Preferred Stock

  

Common Stock

  

Paid-in-

  

Accumulated

  

Comprehensive

  

Stockholders’

 
  

Shares

  

Amount

  

Shares

  

Amount

  

Shares

  

Amount

  

Capital

  

Deficit

  

Income (Loss)

  

(Deficit) Equity

 

Balance December 31, 2022

    $     $   6,644,299  $7  $230,399  $(222,997) $  $7,409 

Common stock and warrants issued, net of issuance costs $351

              386,667      2,545         2,545 

Change in fair value of convertible note attributed to credit risk

                          106   106 

Stock-based compensation

                    695         695 

Net loss

                       (11,039)     (11,039)

Balance - March 31, 2023

    $     $   7,030,966  $7  $233,639  $(234,036) $106  $(284)

Common stock and warrants issued, net of issuance costs $2,168

              967,000   1   5,576         5,577 

Change in fair value of convertible note attributed to credit risk

                          (128)  (128)

Stock-based compensation

                    544         544 

Shares issued as repayment of principal and interest for convertible note

              40,867      200         200 

Net loss

                       (8,717)     (8,717)

Balance - June 30, 2023

    $     $   8,038,833  $8  $239,959  $(242,753) $(22) $(2,808)

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 

NRX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

 

   

Six months ended June 30,

 
   

2024

   

2023

 

CASH FLOWS FROM OPERATING ACTIVITIES:

               

Net loss

  $ (14,425 )   $ (19,756 )

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation expense

    2       2  

Stock-based compensation

    339       1,239  

Change in fair value of warrant liabilities

    (9 )     (1 )

Change in fair value of convertible promissory note

    341       2,435  

Warrant issuance costs related to Alvogen termination

    1,336        

Convertible note default penalty

    849        

Non-cash settlement expense

          250  

Changes in operating assets and liabilities:

               

Prepaid expense and other assets

    (648 )     922  

Accounts payable

    4,209       129  

Insurance loan payable

    943        

Accrued expense and other liabilities

    830       879  

Net cash used in operating activities

    (6,233 )     (13,901 )

CASH FLOWS FROM INVESTING ACTIVITIES

               

Purchase of computer equipment

          (2 )

Net cash used in investing activities

          (2 )

CASH FLOWS FROM FINANCING ACTIVITIES

               

Repayment of convertible note

    (2,156 )     (90 )

Proceeds from issuance of insurance loan

          786  

Proceeds from issuance of common stock and warrants, net of issuance costs

    4,665        

Proceeds from issuance of common stock and warrants issued in private placement, net of issuance costs

    1,027       8,122  

Net cash provided by financing activities

    3,536       8,818  
                 

Net decrease in cash and cash equivalents

    (2,697 )     (5,085 )

Cash and cash equivalents at beginning of period

    4,595       20,054  

Cash and cash equivalents at end of period

  $ 1,898     $ 14,969  

Supplemental disclosure of cash flow information:

               

Cash paid for interest

  $ 374     $ 205  

Cash paid for taxes

  $     $  

Non-cash investing and financing activities

               

Issuance of common stock as principal and interest repayment for convertible notes

  $ 400     $ 200  

Issuance of common stock warrants as offering costs

  $ 188     $ 75  

Conversion of Series A preferred stock into common stock

  $ 3     $  

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

NRX PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2024

(Unaudited)

 

 

1. Organization

 

The Business

 

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRX” or the Company”) is a clinical-stage bio-pharmaceutical company which develops and intends to 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 post-traumatic stress disorder (“PTSD”) and now schizophrenia. All of our current drug development activities are focused drugs that modulate 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. The Company has two lead drug candidates that are expected to be submitted by year end for Food and Drug Administration (“FDA”) approval with anticipated FDA decision dates under the Prescription Drug User Fee Act ("PDUFA") by the end of June 2025: NRX-101, an oral fixed dose combination of D-cycloserine and lurasidone and NRX-100, a preservative-free formulation of ketamine for intravenous infusion. In February 2024, the Company incorporated HOPE as a wholly-owned subsidiary and in August 2024 completed a carve-out audit of HOPE's financial statements which are necessary for the intended Spin-Off (as defined in Note 7) of HOPE to the Company's shareholders at a future date.

 

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 to the development of intravenous ketamine (NRX-100/HTX-100) for the treatment of suicidal depression. 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.

 

 

2. Going Concern

 

Since inception, the Company has experienced net losses and negative cash flows from operations each fiscal year and has a working capital deficit at June 30, 2024. The Company has no revenues and expects to continue to incur operating losses for the remainder of 2024. Although the Company projects operating income to be derived from the operation of clinical facilities through its HOPE subsidiary and sales of its pharmaceutical products in 2025, these projections are subject to completion of anticipated clinical acquisitions in the first case and regulatory approvals in the latter case. In the absence of these projected developments, the Company’s ability to support its ongoing capital needs is dependent on its ability to continue to raise equity and/or debt financing, which may not be available on favorable terms, or at all, in order to continue operations.

 

As of June 30, 2024, the Company had $1.9 million in cash and cash equivalents. Subsequently, on August 12, 2024, the Company signed an agreement with Anson Funds for $16.3 million in Senior Secured Debt financing. Concurrently, the Company signed a settlement agreement with Streeterville Capital, LLC to retire its remaining debt for a settlement amount of $5.6 million and to settle outstanding litigation. This settlement amount was substantially less than the amounts claimed by Streeterville in litigation. 

 

The Company has now secured operating capital that it anticipates as sufficient to fund its drug development operations through year end and to finance submission of FDA New Drug Applications for NRX-100 and NRX-101 in 2024. The Company may 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. 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 regarding 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. 

 

7

 

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.

 

 

 

3. Summary of Significant Accounting Policies

 

On April 1, 2024, the Company effected a reverse stock split (the “Reverse Stock Split”) of the Company’s common stock, $0.001 par value (“Common Stock”), at a ratio of 1-for-10. All historical share amounts, with the exception of the Company’s Series A Preferred Stock, disclosed in this Quarterly Report on Form 10-Q have been retroactively adjusted to reflect the Reverse Stock Split. No fractional shares were issued as a result of the Reverse Stock Split, as fractional shares of Common Stock were rounded up to the nearest whole share. See Note 9. Equity for additional information.

 

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”), provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the 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.

 

8

 

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 June 30, 2024 the Company’s cash and cash equivalents balance within money market accounts was in excess of the U.S. federally insured limits by $1.3 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”) or other accounting standards for revenue not derived from customers. Arrangements may include licenses to intellectual property, research services and participation on joint research committees. The Company evaluates the promised goods or services to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, the Company considers the stage of research, the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property, and whether the promised goods or services are integral to or dependent on other promises in the contract. 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 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.

 

9

 

The License Agreement (the “License Agreement”) with Alvogen Pharma US, Inc., Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (collectively, “Alvogen”) (as further discussed in Note 6 below) was accounted for in accordance with ASC 606. In 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 may 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.

 

10

 

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 incurred research costs in association with the License Agreement. After the First Milestone Payment (as defined in Note 6 below), the Company would have been reimbursed for certain costs incurred related to reasonable and documented out-of-pocket costs for clinical and non-clinical development activities. The Company would have recognized revenue for the reimbursed costs when the First Milestone Payment contingencies had been achieved and the Company had an enforceable claim to the reimbursed costs.

 

Research and Development Costs

 

Research and development expense consists 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.

 

Convertible Note Payable and Fair Value Election

 

As permitted under FASB ASC Topic 825, Financial Instruments (“ASC 825”), the Company elected to account for its promissory note, which meets the required criteria, at fair value at inception. Subsequent changes in fair value are recorded as a component of non-operating loss in the consolidated statements of operations. The portion of total changes in fair value of the note attributable to changes in instrument-specific credit risk are determined through specific measurement of periodic changes in the discount rate assumption exclusive of base market changes and are presented as a component of comprehensive income in the accompanying condensed consolidated statements of operations and comprehensive loss. As a result of electing the fair value option, direct costs and fees related to the promissory notes are expensed as incurred.

 

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. For the valuation as of  December 31, 2023, the probability of default was estimated using Bloomberg’s Default Risk function which uses its financial information to calculate a default risk specific to the Company. For the valuation as of  June 30, 2024, the probability of default was based on management's estimates which include, the Company's current cash runway, current efforts to raise financing, and current economic environment. 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.

 

11

 

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”) and FASB ASC Topic 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 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 Entitys Own Equity, the Series A Preferred Stock did not meet any of the criteria that would preclude equity classification. The Company concluded that the Series A Preferred Stock was more akin to an equity-type instrument than a debt-type instrument, therefore the conversion features associated with the convertible preferred stock were deemed to be clearly and closely related to the host instrument and were not bifurcated as a derivative under ASC 815.

 

12

 

Income Taxes

 

Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the 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. 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.

 

  

Six months ended June 30,

 
  

2024

  

2023

 

Stock options

  161,437   254,885 

Restricted stock awards

  66,666   100,000 

Common stock warrants

  4,069,240   3,002,159 

  

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 six months ended June 30, 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.

 

13

 

 

4. Prepaid Expense and Other Current Assets

 

Prepaid expense and other current assets consisted of the following at the dates indicated (in thousands):

 

   

June 30, 2024

   

December 31, 2023

 
   

(Unaudited)

         

Prepaid expense and other current assets:

               

Prepaid insurance

  $ 1,500     $ 1,078  

Prepaid clinical development costs

    830       871  

Other prepaid expense

    646       334  

Other current receivables

    6       6  

Total prepaid expense and other current assets

  $ 2,982     $ 2,289  

 

 

5. Accrued and Other Current Liabilities

 

Accrued and other current liabilities consisted of the following at the dates indicated (in thousands):

 

   

June 30, 2024

   

December 31, 2023

 
   

(Unaudited)

         

Accrued and other current liabilities:

               

Refund liability (see Note 6)

  $ 3,826     $  

Professional services

    3,593       2,686  

Accrued employee costs

    1,062       835  

Accrued research and development expense

    900       1,112  

Other accrued expense

    213       81  

Total accrued and other current liabilities

  $ 9,594     $ 4,714  

 

 

6. Alvogen Licensing Agreement 

 

In June 2023, the Company entered into a License Agreement with Alvogen. Under the License Agreement, the Company granted Alvogen certain license rights to develop, manufacture, and commercialize the Company’s candidate therapeutic product, NRX-101, for the treatment of bipolar depression with suicidality. In exchange for the license granted and the participation of the Company in certain development, regulatory and commercial activities, Alvogen was obligated to pay the Company specified regulatory and commercial milestones, the first of which was $9 million 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”). In February 2024, the parties executed an amendment accelerating payment of up to $5 million related to the First Milestone Payment, with the remaining $4 million due upon the original agreement’s terms (see below for advances received through June 30, 2024). As compensation for advancing the milestone, Alvogen received warrants to purchase up to 419,598 shares of the Company's Common Stock, at a strike price of $4.00 with a three year term (See Note 9). The grant date fair value of the warrants was approximately $1.3 million, which the Company planned to account for as consideration paid to a customer (see below). The second portion of the first milestone was to be $4 million and, as before, triggered by a positive response to the Company's planned end of phase 2 meeting with FDA. If the first milestone was not achieved by September 3, 2024, the Company would be obligated to repay any amount received against the $5 million advance of the First Milestone Payment to Alvogen. As there was significant uncertainty relative to approval of any drug candidate in development, the Company concluded that it was not probable that a significant reversal of revenue would 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 was fully constrained and advances from Alvogen were recorded as a refund liability until such time as the refund right expired. Further, the Company accounted for the warrants issued to Alvogen within additional paid-in capital consistent with the accounting for unfunded stock subscription agreements until such time as the uncertainty around the First Milestone was resolved.  

 

Termination 

 

Under the License Agreement, as amended, Alvogen was granted early termination rights. On June 21, 2024, the Company received a notice of termination from Alvogen effective immediately. Following the termination of the License Agreement by Alvogen, the amounts advanced pursuant to the amendment became due and payable to Alvogen. Accordingly, the refund liability has not been reclassified as deferred revenue or recorded as revenue as of June 30, 2024.

 

Upon termination of the License Agreement, the intellectual property rights licensed to Alvogen under the License Agreement reverted to the Company, and all other rights and obligations of each of the parties immediately ceased, except for outstanding amounts owed as of the time of such expiration or termination. As of June 30, 2024, the refund liability due to Alvogen was $3.8 million, which represent all payments made by Alvogen through June 30, 2024, and is included as a component of accrued expense and other current liabilities on the condensed consolidated balance sheet. Following the early termination by Alvogen, the Company does not anticipate recognizing any revenue under the License Agreement. Additionally, the Company wrote-off the unfunded stock subscription receivable of $1.3 million related to the warrants previously classified in additional paid-in capital to research and development expense following the termination. 

 

14

 

 

 

7. Debt

 

Convertible Note

 

On November 4, 2022, the Company issued an 9% redeemable promissory note (as amended, the “Note”) to Streeterville Capital, LLC, a Utah limited liability company (“Streeterville”), for an aggregate principal amount of $11.0 million. The Note originally matured 18 months from the date of issuance subject to certain acceleration provisions. The Note carries an original issue discount of $1.0 million which was deducted from the principal balance of the Note. The net proceeds from the issuance of the Note was $10.0 million after transaction costs including the original issue discount, legal and other fees are included.

 

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”). Payments may be made by the Company at their option in: (i) in cash with a 10% premium (the “Redemption Premium”) for the amount redeemed, (ii) by paying the redemption amount in the form of shares of Common Stock with the number of redemption shares being equal to the portion of the applicable redemption amount divided by the Redemption Conversion Price (as defined below), or (iii) a combination of cash and shares of Common Stock. The “Redemption Conversion Price” on any given redemption date equals 85% multiplied by the average of the two lowest daily volume weighted average prices per share of the Common Stock during the ten trading days immediately preceding the date that the noteholder delivers notice electing to redeem a portion of the Note. Beginning May 1, 2023, in the event (a) the daily dollar trading volume of the Common Stock of the Company on any given trading day is at least fifty percent (50%) greater than the lower of (i) the median daily dollar trading volume over the previous ten (10) trading days or (ii) the daily dollar trading volume on the trading day immediately preceding the date of measurement or (b) if the closing trade price on any given trading day is at least thirty percent (30%) greater than the Nasdaq Minimum Price, then the lender will be entitled to redeem over the following ten (10) trading days an amount of indebtedness then outstanding under the Note equal to twice the monthly redemption amount of $1.0 million solely by payment by stock, if permitted under the agreement, subject to the Maximum Percentage (as defined in the Note) and other ownership limitations.

 

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 Note (such event, an “Event of Default”). Upon an Event of a Default, the Lender may consider the Note immediately due and payable. Upon an Event of Default, the interest rate may also be increased to the lesser of 18% per annum or the maximum rate permitted under applicable law (see below). 

 

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”), pursuant to which the Maximum Percentage was set at 9.99% of the number of shares of Common Stock outstanding on a given date.

 

On July 7, 2023, the Company entered into Amendment #2 to the Note with Streeterville (the “Second Amendment”). Pursuant to the Second Amendment, the Company agreed to amend the redemption provisions of the Note to provide that the Company would pay to Streeterville an amount in cash equal to $1.8 million on or before July 10, 2023, which amount was paid on July 10, 2023. In addition, the Company agreed that, beginning on or before July 31, 2023, and on or before the last day of each month until December 31, 2023 (the Company would pay Streeterville an amount equal to $0.4 million in cash), less any amount satisfied by the delivery of Redemption Conversion Shares (as defined below). Notwithstanding the foregoing, Streeterville may also submit a request for redemption of up to an aggregate of $1.0 million per month in 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.

 

15

 

On February 9, 2024, the Company entered into Amendment #3 to the Note (the “Third Amendment”), with Streeterville. In accordance with the Third Amendment, the Company and Streeterville agreed to amend the redemption provisions of the Note to provide that the Company would pay to Streeterville an amount in cash equal to $1.1 million on February 12, 2024, which the amount was paid on February 12, 2024. In addition, beginning on or before February 29, 2024, and on or before the last day of each month until July 31, 2024, the Company shall pay Streeterville an amount equal to $0.4 million in cash, less any amount satisfied by the delivery of Redemption Conversion Shares. During the first three months of this amended payment period, Streeterville may not request to redeem amounts greater than $0.4 million per month.

 

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. As a result of the alleged Event of Default mentioned below, the Company did not pay any Redemption Amounts during the three months ended June 30, 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”) calculated on the basis of the Redemption Conversion Price (as defined in the Note) without regard to the existence of an Equity Conditions Failure. Moreover, the Redemption Premium (as defined in the Note) will continue to apply to the Redemption Amounts.

 

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 Note 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 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 and six months ended June 30, 2024, the Company recorded a loss from the change in fair value of the Note of less than $0.1 million and $0.3 million, respectively, which was recognized in other (income) expense on the condensed consolidated statements of operations as a result of the Company’s election of the fair value option. For the three and six months ended June 30, 2023, the Company recorded a loss from the change in fair value of the Note of $0.7 million and $2.4 million, respectively, which was recognized in other (income) expense on the condensed consolidated statements of operations as a result of the Company’s election of the fair value option.

 

During the three and six months ended June 30, 2024, the Company made cash payments for coupon interest on the Note of approximately $0.1 million, and $0.2 million of redemption premiums, issued shares of Common Stock as coupon interest repayment of $0.1 million, and incurred a default penalty of $0.8 million. During the three and six months ended June 30, 2023, the Company made interest payments on the Note of approximately $0.1 million and issued shares of Common Stock as principal and interest repayments on the Note of $0.2 million.

 

16

 

As of June 30, 2024, and December 31, 2023, the Note carried a remaining principal balance of $6.5 million and $8.3 million, respectively. Refer to Note 11 for the reconciliation of the fair values for the periods presented.

 

Alleged Default

 

On April 24, 2024, the Company received written notice from counsel for Streeterville that an alleged event of default occurred with respect to Note issued by the Company in favor of Streeterville (the “Notice”). The Notice alleges that, among other things, (i) the announcement of the plan to partially spin-off of HOPE (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 in 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, resulting in the acceleration of all of the outstanding amounts due thereunder.

 

Streeterville also 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 Common Stock or other equity securities (such as the shares of HOPE 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 $6,537,027, or the amounts currently outstanding under the Note.

 

On July 29, 2024, in connection with the alleged Event of Default that Streeterville claimed occurred with respect to the Note, the Company announced an order of the Utah arbitrator denying the petition of Streeterville to enjoin Spin-Off of 49% of shares in HOPE to current shareholders of the Company. The purpose of the proposed Spin-Off was to provide the Company’s shareholders with valuable consideration and to provide HOPE (currently a wholly-owned subsidiary) with a sufficient shareholder base to enable future listing on a a national exchange. The arbitrator also denied Streeterville’s petition to enjoin the Company from selling additional shares of Common Stock to finance ongoing operations (see Note 14).

 

8. Commitments and Contingencies

 

Sarah Herzog Memorial Hospital License Agreement

 

The Company is required to make certain payments related to the development of NRX-101 (the "Licensed Product") in order to maintain the license agreement with the Sarah Herzog Memorial Hospital Ezrat Nashim (“SHMH”) (the "SHMH License Agreement"), including:

 

Milestone Payments

 

End of Phase I Clinical Trials of Licensed Product (completed)

 $100,000 

End of Phase II Clinical Trials of Licensed Product (completed)

 $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 and six months ended June 30, 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. During the three and six months ended June 30, 2023, no royalty payments were made.

 

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 and six months ended June 30, 2024 and 2023, the Company has recorded no expenses relating to the licensure of the patent. 

 

17

 

Legal Proceedings

 

 

The Company is a defendant in litigation filed by Streeterville in the Third Judicial District Court of Salt Lake County, Utah. See Note 7, Debt, for additional information. The Complaint seeks, among other things: (i) declaratory relief for an order enjoining the Company from undertaking any Fundamental Transaction, including the Spin-Off, or otherwise issuing Common Stock or other equity securities (such as the shares of HOPE 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 $6,537,027, or the amounts currently outstanding under the Note.

 

 

On July 29, 2024, in connection with the alleged Event of Default that Streeterville claimed occurred with respect to the Note, the Company announced an order of the Utah arbitrator denying the petition of Streeterville to enjoin the planned Spin-Off of 49% of shares in HOPE to current shareholders of the Company. The purpose of the proposed Spin-Off was to provide the Company’s shareholders with valuable consideration and to provide HOPE (currently a wholly-owned subsidiary) with a sufficient shareholder base to enable future listing on a a national exchange. The arbitrator also denied Streeterville’s petition to enjoin the Company from selling additional shares of Common Stock to finance ongoing operations. This matter was settled subsequent to June 30, 2024.

 

On August 12, 2024, the Company signed a settlement agreement with Streeterville to retire its remaining debt for a settlement amount of $5.6 million and to settle outstanding litigation. This settlement amount was substantially less than the amounts claimed by Streeterville in its Compliant (see Note 14).

 

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, other than as set forth above, 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.

 

 

9. Equity

 

Common Stock Reverse Stock Split

 

On March 21, 2024, the Board approved a reverse stock split ratio of 1-for-10. On March 28, 2024, the Company filed an amendment to its certificate of incorporation in the State of Delaware (the “Amendment”), which provided that, effective as of 4:30 p.m. Eastern Standard Time on April 1, 2024 (the “Effective Time”), every ten shares of its issued and outstanding Common Stock will automatically be combined into one issued and outstanding share of Common Stock, without any change in the par value per share.

 

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. As a result of the Reverse Stock Split, 73,040 additional shares of common stock were issued in lieu of fractional shares. 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 ("Series A Preferred"). In August 2023, the Company sold and issued 3.0 million shares of Series A Preferred for an aggregate cash purchase price of $1.2 million. During March 2024 holders of the Company’s Series A Preferred elected to convert 3,000,000 shares of Series A Preferred into 300,000 shares of Common Stock. As of June 30, 2024, no shares of Series A Preferred 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 Common Stock 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 April 15, 2024, the Company announced that it entered into multiple purchase agreements (the “ATM Purchase Agreements”) subject to standard closing conditions where accredited investors purchased 282,452 shares of unregistered Common Stock at a range of  $4.643 – $7.10 per share. 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. Through June 30, 2024, the aggregate net cash proceeds to the Company from the ATM Purchases Agreements were approximately $1.4 million.

 

 

18

 

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”) at a price of $3.80 per share of Common Stock and accompanying warrant, which represents a 26.7% premium to the offering price in February 2024 Public Offering. The Common Stock and the February Warrants were offered pursuant to a private placement (the “ February 2024 Private Placement”) under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The aggregate net cash proceeds to the Company from the February 2024 Private Placement were approximately $1.0 million. As of June 30, 2024, the shares of Common Stock had not been issued.

 

On February 27, 2024, the Company entered into an underwriting agreement (the “ February Underwriting Agreement”) with EF Hutton LLC (the “Representative”), as the representative of the several underwriters named therein (the “ February Underwriters”), relating to an underwritten public offering (the “ February 2024 Public Offering”) of 500,000 shares (the “ February Shares”) of the Company’s Common Stock. The public offering price for each share of Common Stock was $3.00 and the February Underwriters purchased the shares of Common Stock pursuant to the February Underwriting Agreement at a price for each share of Common Stock of $2.76. Pursuant to the February Underwriting Agreement, the Company also granted the Representative a 45-day option to purchase up to an additional 75,000 shares (the “ February Option Shares”) of the Common Stock on the same terms as the February Shares sold in the February 2024 Public Offering (the “ February Over-Allotment Option”). On February 28, 2024, the February 2024 Public Offering closed (the “ February Closing Date”). The aggregate net cash proceeds to the Company from the February 2024 Offering proceeds were approximately $1.3 million after offering costs of approximately $0.4 million. On March 5, 2024, the February Underwriters of the previously announced underwritten public offering of the Company exercised their option in accordance with the February Underwriting Agreement, dated February 27, 2024, by and between the Company and the Representative, as representative of the several underwriters named therein, to purchase up to an additional 75,000 shares of the Company’s Common Stock, at a public offering price of $3.00 per share (the “ February Overallotment Exercise”). The February Overallotment Exercise closed on March 6, 2024. The aggregate net cash proceeds to the Company from the February Overallotment Exercise were approximately $0.2 million. The Company accrued additional offering costs of approximately $0.2 million.

 

On April 18, 2024, the Company entered into an underwriting agreement (the “ April Underwriting Agreement”) with the Representative, as the representative of the several underwriters named therein (the “ April Underwriters”), relating to an underwritten public offering (the “ April 2024 Public Offering”) of 607,000 shares (the “April Shares”) of Common Stock. The public offering price for each share of Common Stock was $3.30. Pursuant to the April Underwriting Agreement, the Company also granted the Representative a 45-day option to purchase up to an additional 91,050 shares (the “ April Option Shares”) of the Common Stock on the same terms as the April Shares sold in the April 2024 Public Offering (the “ April Over-Allotment Option”). On April 19, 2024, the Offering closed (the “ April Closing Date”). Net proceeds from the April 2024 Public Offering were approximately $1.6 million after offering costs of approximately $0.4 million. On May 23, 2024, the April Underwriters of the previously announced underwritten public offering of the Company exercised their option in accordance with the April Underwriting Agreement, dated April 18, 2024, by and between the Company and the Representative, as representative of the several underwriters named therein, to purchase up to an additional 91,050 shares of the Company’s Common Stock, at the public offering price of $3.30 per share (the “ April Overallotment Exercise”). The April Over-Allotment Exercise was exercised in full and closed on May 23, 2024. The net cash proceeds to the Company from the April Overallotment Exercise were approximately $0.2 million which include offering costs of less than $0.1 million.

 

Common Stock Warrants

 

Substitute Warrants

 

In connection with the Merger in 2021, each warrant to purchase shares of Common Stock of NRx that was outstanding and unexercised immediately prior to the effective time (whether vested or unvested) was assumed by Big Rock Partners Acquisition Corp. ("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”). There were 3,792,970 warrants outstanding and unexercised at the effective time. As these Substitute Warrants meet the definition of a derivative as contemplated in FASB ASC Topic 815, based on provisions in the warrant agreement related to the Earnout Shares Milestone and the Earnout Cash Milestone and the contingent right to receive additional shares for these provisions, the Substitute Warrants were recorded as derivative liabilities on the consolidated balance sheet and measured at fair value at inception (on the date of the Merger) and at each reporting date in accordance with FASB ASC Topic 820, with changes in fair value recognized in the statements of operations in the period of change. 

 

The Company recognized a loss on the change in fair value of the Substitute Warrants for the three months ended  June 30, 2024 and 2023 of less than $0.1 million and less than $0.1 million, respectively. The Company recognized a gain on the change in fair value of the Substitute Warrants for the six months ended June 30, 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 warrants outstanding (the “Public Warrants”) to purchase up to 345,000 shares of Common Stock. Each Public Warrant entitles the holder to purchase one-tenth share of Common Stock at an exercise price of $115 per share. The Public Warrants became exercisable at the effective time of the Merger and expire five years after the effective time on or earlier upon their redemption or liquidation of the Company.

 

During the three and six months ended June 30, 2024 and 2023 no Public Warrants were exercised. The outstanding balance of these public warrants remains in equity. At June 30, 2024 and December 31, 2023, there were 3,448,856 Public Warrants outstanding to purchase up to 344,886 shares of Common Stock.

 

19

 

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 FASB ASC Topic 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 June 30, 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 on the change in fair value of the Private Placement Warrants for the three months ended June 30, 2024 and 2023 of less than $0.1 million and less than $0.1 million, respectively. The Company recognized a loss on the change in fair value of the Private Placement Warrants for the six months ended June 30, 2024 and 2023 of less than $0.1 million and 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 270,000 shares of the Company’s Common Stock, the Company issued  February Warrants to purchase up to 270,000 shares of Common Stock which were classified in stockholder’s equity. The February Warrants have an exercise price of $3.80 per share, are initially exercisable beginning six months following the date of issuance, and will expire five years from the date of issuance. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.59, exercise price of $3.80, term of 5 years, volatility of 178.10%, risk-free rate of 4.26%, and expected dividend rate of 0%). The allocated fair value of the February Warrants on the grant date was $0.5 million and is recorded within additional paid-in capital.

 

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”). The Underwriter’s Warrant is exercisable six months following the date of the Underwriting Agreement and terminates on the five-year anniversary of the date of the Underwriting Agreement. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.05, exercise price of $3.30, term of 5 years, volatility of 178.10%, risk-free rate of 4.26%, and expected dividend rate of 0%). The allocated fair value of the Underwriter's Warrants on the grant date was $0.1 million and is recorded as a charge to additional paid-in capital.

 

On March 5, 2024 the Company issued Underwriter’s Warrant to purchase up to 3,750 shares of Common Stock in relation to the exercise of the February Over-Allotment Option. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.05, exercise price of $3.30, term of 5 years, volatility of 178.10%, risk-free rate of 4.12%, and expected dividend rate of 0%). The allocated fair value of the Underwriter's Warrants on the grant date was less than $0.1 million and is recorded as a charge to additional paid-in capital.

 

On April 19, 2024, the Company issued to the Representative the April Underwriter’s Warrant to purchase up to 30,350 shares of Common Stock (the “ April Underwriter Warrant Shares”). The April Underwriter’s Warrant is exercisable six months following the date of the Underwriting Agreement and terminates on the five-year anniversary of the date of the Underwriting Agreement. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.04, exercise price of $3.63, term of 5 years, volatility of 178.10%, risk-free rate of 4.66%, and expected dividend rate of 0%). The allocated fair value of the April Underwriter's Warrant on the grant date was less than $0.1 million and is recorded as a charge to additional paid-in capital.

 

On May 23, 2024 the Company issued Underwriter’s Warrant to purchase up to 4,553 shares of Common Stock in relation to the exercise of the April Over-Allotment Option. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.62, exercise price of $3.63, term of 5 years, volatility of 178.10%, risk-free rate of 4.52%, and expected dividend rate of 0%). The allocated fair value of the Underwriter's Warrants on the grant date was less than $0.1 million and is recorded as a charge to additional paid-in capital.

 

Alvogen Warrants

 

In conjunction with the amended Alvogen licensing agreement discussed in Note 6, on February 7, 2024 the Company issued warrants to purchase up to 419,598 shares of Common Stock. The warrants have an exercise price of $4.00 per share, are exercisable immediately following the date of issuance, will expire three years from the date of issuance, and may also be exercised on a cashless basis if there is no effective registration statement available for the resale of the shares of Common Stock underlying the warrants. The warrants are subject to a beneficial ownership limitation of 4.99% post-exercise, with the exception that the beneficial ownership limitation may be waived up to a maximum of 9.99% at the election of the holder, with not less than 61 days prior notice. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $4.10, exercise price of $4.00, term of 3 years, volatility of 138.0%, risk-free rate of 4.2%, and expected dividend rate of 0.0%). The fair value of the warrants on the grant date was $1.3 million and was recorded within additional paid-in capital as of March 31, 2024. Upon termination of the Alvogen Agreement on June 21, 2024, the offsetting amount recorded within additional paid-in capital as an unfunded stock subscription receivable was expensed to research and development.

 

 

      

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 

Issued

  34,903             

Outstanding as of June 30, 2024

  4,069,240   3.44  $19.47  $ 

 

20

 

 

10. Stock-Based Compensation

 

2016 Omnibus Incentive Plan

 

Prior to the Merger, NRx maintained its 2016 Omnibus Incentive Plan (the “2016 Plan”), under which NeuroRx granted incentive stock options, restricted stock awards, other stock-based awards, or other cash-based awards to employees, directors, and non-employee consultants. The maximum aggregate shares of Common Stock that were subject to awards and issuable under the 2016 Plan was 347,200.

 

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  June 30, 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”). As of January 1, 2024, 83,920 shares were added to the 2021 Plan under an evergreen feature that automatically increases the reserve with additional shares of Common Stock 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 increased the maximum number of shares (i) available for issuance under the Plan, by an additional 200,000 shares, and (ii) that may be delivered pursuant to the exercise of Incentive Stock Options granted under the Plan to be equal to 100% of the Share Pool. As of June 30, 2024, an aggregate 608,365 shares have been awarded net of forfeitures, and 346,916 shares remain available for issuance under the 2021 Plan. The 2021 Plan permits the granting of incentive stock options, restricted stock awards, other stock-based awards or other cash-based awards to employees, directors, and non-employee consultants.

 

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 or six months ended June 30, 2024.

 

21

 

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 

Expired/Forfeited

  (14,000)            

Outstanding as of June 30, 2024

  161,437  $21.18   7.5  $ 

Options vested and exercisable as of June 30, 2024

  126,882  $25.18   7.0  $ 

 

Stock-based compensation expense related to stock options was $0.1 million and $0.3 million for the three and six months ended June 30, 2024, respectively.

 

At June 30, 2024, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted, was $0.1 million, which the Company expects to recognize over a weighted-average period of approximately 1.2 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 

Vested

      

Balance as of June 30, 2024 (unvested)

  66,666  $5.66 

 

On July 12, 2022, the Board granted an award of 100,000 restricted shares of the Company (“RSAs”) as an inducement to the newly appointed CEO, pursuant to a separate Restricted Stock Award Agreement. The RSAs will vest in approximately equal installments over three (3) years from the grant date, subject to continued service through the applicable vesting date.

 

On December 28, 2023, the Company was authorized to grant 57,500 RSAs to a consultant for services provided. The RSAs vested after six months from September 4, 2023, the date the services began. The shares were valued on the grant date based on the quoted price of $4.60 or approximately $0.3 million which was amortized over the vesting term.

 

Stock-based compensation expense related to RSAs was less than $0.1 million for the three and six months ended June 30, 2024 respectively.

 

As of June 30, 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 1.0 years.

 

22

 

The following table summarizes the Company’s recognition of stock-based compensation for the following periods (in thousands):

 

  

Three months ended June 30,

  

Six months ended June 30,

 
  

2024

  

2023

  

2024

  

2023

 
  

(Unaudited)

 

Stock-based compensation expense

                

General and administrative

 $72  $443  $283  $1,034 

Research and development

  25   101   56   205 

Total stock-based compensation expense

 $97  $544  $339  $1,239 

 

 

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 and six months ended June 30, 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 June 30, 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

   

June 30, 2024

   

December 31, 2023

 

Assets:

         

(Unaudited)

         

Money Market Account

    1     $ 475     $ 3,874  
                         

Liabilities:

                       

Warrant liabilities (Note 9)

    3     $ 8     $ 17  

Convertible note payable (Note 7)

    3     $ 7,651     $ 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:

 

   

June 30,

 
   

2024

   

2023

 

Stock price on valuation date

  $ 2.44     $ 4.84  

Time to expiration

    0.17       0.84  

Note market interest rate

    20.6 %     8.9 %

Equity volatility

    145.0 %     100.0 %

Volume volatility

    560.0 %     455.0 %

Risk-free rate

    5.48 %     5.42 %

Probability of default

    50.0 %     6.5 %

 

23

 

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  

Conversions and repayments of principal and interest (shares and cash)

     

Fair value adjustment through earnings

    23  

Default penalty

    849  

Fair value adjustment through accumulated other comprehensive loss

     

Fair value of the Note as of June 30, 2024

  $ 7,651  
         

Convertible note payable - current portion

  $ 7,651  

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  

Conversions and repayments of principal and interest (shares and cash)

    (288 )

Fair value adjustment through earnings

    665  

Fair value adjustment through accumulated other comprehensive loss

    128  

Fair value of the Note as of June 30, 2023

  $ 12,694  
         

Convertible note payable - current portion

  $ 12,694  

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:

 

   

June 30,

 
   

2024

   

2023

 

Stock price on valuation date

  $ 2.44     $ 6.60  

Exercise price per share

  $ 115.00     $ 115.00  

Expected life

    1.90       3.15  

Volatility

    176.9 %     175.1 %

Risk-free rate

    4.8 %     5.3 %

Dividend yield

    0.0 %     0.0 %

Fair value of warrants

  $ 0.60     $ 7.93  

 

24

 

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  

Gain upon re-measurement

    (18 )

Balance as of June 30, 2024

  $ 8  

 

Balance as of December 31, 2022

  $ 37  

Gain upon re-measurement

    (12 )

Balance as of March 31, 2023

    25  

Loss upon re-measurement

    11  

Balance as of June 30, 2023

  $ 36  

 

 

12. Income Taxes

 

The Company recorded no provision or benefit for income tax expense for the six months ended June 30, 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 June 30, 2024.

 

 

 

13. Related Party Transactions

 

Glytech Agreement

 

The Company licenses patents that are owned by Glytech, LLC (“Glytech”), pursuant to a license agreement (the “Glytech Agreement”). Glytech is owned by Daniel Javitt, a co-founder and former director of the Company. The Glytech Agreement requires that the Company pay Glytech for ongoing scientific support and also reimburse Glytech for expenses of obtaining and maintaining patents that are licensed to the Company. During both the three months ended  June 30, 2024 and 2023, the Company paid Glytech $0.1 million for continuing technology support services and reimbursed expenses. During both the six months ended   June 30, 2024 and 2023, the Company paid Glytech $0.1 million for continuing technology support services and reimbursed expenses. These support services are ongoing. 

 

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”) has an aggregate liquidity value of at least $50 million for twenty (20) consecutive trading days immediately preceding any given date and (ii) there are no legal or contractual restrictions on selling all of the securities represented by the Glytech Equity then applicable to Glytech (or reasonably foreseeable to be applicable to Glytech within the following twenty trading days). The option was not exercised and expired on March 31, 2024.

 

Consulting Agreement with Dr. Jonathan Javitt

 

The Chief Scientist of the Company, Dr. Jonathan Javitt, is a major shareholder in the Company and is the Chairman of the Board of Directors. Therefore, the services provided to the Company 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 and received compensation of $0.2 million and $0.1 million during the three months ended June 30, 2024 and 2023, respectively, and $0.4 million and $0.5 million during the six months ended June 30, 2024 and 2023, respectively.

 

25

 

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 provided for payment at the rate of $0.6 million per year, payable monthly (i.e., less than $0.1 million per month), and a performance-based annual bonus with a minimum target of $0.3 million, at the discretion of the Board and upon satisfactory performance of the services. The annual discretionary bonus for 2023, if any, may be approved by the Board in 2024 and is payable in March 2024, will be pro-rated from the start of the extension period and is subject to Dr. Javitt’s continued engagement by the Company. As of June 30, 2024 and December 31, 2023, the annual discretionary bonus of $0.3 million and $0.2 million is accrued and included within accrued and other current liabilities on the condensed consolidated balance sheets, respectively.

 

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 June 30, 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 less than $0.1 million during the three and six months ended June 30, 2024 and 2023, respectively. These services are ongoing.

 

Included in accounts payable were less than $0.1 million due to the above related parties as of  June 30, 2024 and December 31, 2023, respectively.

 

 

 

 

14. Subsequent Events

 

At-The Market Offering Agreement

 

From July 11, 2024 to July 30, 2024, the Company announced that it entered into multiple purchase agreements (the “ATM Purchase Agreements”) subject to standard closing conditions where accredited investors purchased 103,063 shares of unregistered Common Stock at a range of  $2.421 – $2.528 per share. Subsequent to June 30, 2024, the Company sold additional shares of Common Stock at an aggregate sales price of $0.3 million.

 

Nasdaq Listing Compliance

 

On August 6, 2024, the Company received a letter (the “Letter”) from the Listing Qualifications Staff of The Nasdaq Stock Market, LLC (“Nasdaq”) indicating the from June 14, 2024 to August 5, 2024, the Company's Market Value of Listed Securities (“MVLS”) was below the minimum of $35 million required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the “MVLS Requirement”). In accordance with the Nasdaq Listing Rule 5810(c)(3)(C), the Company has 180 calendar days from the date of the Letter, or through February 3, 2024 to regain compliance with respect to the MVLS Requirement. 

 

Securities Purchase Agreement

 

On August 12, 2024, the Company executed a Securities Purchase Agreement (the “SPA”) and related agreements, under which the Company agreed to sell and issue, and certain purchasers agreed to purchase, an aggregate of $16.3 million of securities. The consideration payable by the purchasers under the SPA will be comprised of three equal closings, each subject to certain closing conditions. The securities to be issued and sold by the Company include up to $16.3 million of senior secured convertible notes (the “Notes”) and warrants to purchase 1.4 million shares of the Company’s common stock (the “Warrants”). The proceeds are expected to be used to settle the Company’s outstanding amounts owed to Streeterville and other working capital needs. The Company has received the first tranche as of the date of this filing.

 

The Notes bear interest at the rate of 6% per annum and mature in 15 months following their date of issuance. The Notes may be settled in cash or in shares of the Company’s common stock, at the sole discretion of the holder, at the applicable conversion price. The Note may not be prepaid by the Company however, the holders of the Note may elect to convert the Notes, in whole or in part, into shares of the Company’s common stock at any time after the original issuance date. The conversion price will equal the lower of (i) $2.4168 or (ii) a price equal to 92% of the lowest volume-weighted average price during the seven-trading day period immediately preceding the applicable conversion date. The Notes include certain redemption, protection features and default interest and penalties. The Notes are secured by all assets of the Company, including its intellectual property.  

 

The Warrants have a term of 5 years, and exercise price of $2.42 and are exercisable immediately upon issuance. The Company is the process of assessing the accounting treatment of the transaction.

 

Settlement Agreement

 

On August 12, 2024 (the “Effective Date”), the Company entered into a settlement agreement and release of claims (the “Agreement”) with Streeterville. Under the terms of the Agreement, the Company will settle the Note for $5.6 million through two installments. The first installment of $2.5 million is due within five days of the Effective Date, and the second installment of $3.1 million is due within 60 days of the Effective date. The Company agreed that it will not complete the Spin-Off, or any similar transaction, until after it has paid the settlement amount in full.

 

 

 

26

 

 

Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations

 

You should read the following discussion and analysis of NRx Pharmaceuticals financial condition and plan of operations together with NRx Pharmaceuticals' 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. All references to Note, followed by a number reference from 1 to 14 herein, refer to the applicable corresponding numbered footnotes to these condensed consolidated financial statements.

 

Overview

 

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”), novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, and post-traumatic stress disorder (“PTSD”) and now schizophrenia. All of our current drug development activities are focused drugs that modulate 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. The Company has two lead drug candidates that are expected to be submitted by year end for Food and Drug Administration ("FDA") approval with anticipated FDA decision dates under the Prescription Drug User Fee Act (“PDUFA”) by the end of June 2025: NRX-101, an oral fixed dose combination of D-cycloserine and lurasidone and NRX-100, a preservative-free formulation of ketamine for intravenous infusion. In February 2024, the Company incorporated HOPE as a wholly-owned subsidiary and in August 2024 completed an audit of HOPE's financial statements necessary for the intended Spin-Off (as defined in above) of HOPE to the Company's shareholders at a future date.

 

During the second quarter of 2024 and in the subsequent period, the Company has achieved the following:

 

 

We consummated a financing agreement with an institutional investors for $16.3 million in debt capital, sufficient to finance the submission of New Drug Applications for NRX-100 and NRX-101.

 

 

We settled litigation with Streeterville Capital, LLC at a substantial discount to the amounts claimed, thereby clearing the path to proposed partial spin-off of HOPE, our wholly-owned subsidiary, to our shareholders.

 

 

We recorded positive data from a Phase 2b/3 trial of NRX-101 in Suicidal Bipolar Depression, demonstrating significant reduction of akathisia (P=0.025) and significant improvement in time to resolution of suicidality (P<.05), while demonstrating comparable antidepressant efficacy to standard of care. Akathisia is a potentially lethal side effect of all serotonin-targeted antidepressants and is associated with suicide.

 

 

The above findings of reduced suicidality and akathisia confirm the results of the Company’s prior STABIL-B trial in acutely suicidal patients and also mirror the results of an independent published trial;

 

 

The Company plans to file a New Drug Application (“NDA”) in Q4 2024 for Accelerated Approval under Breakthrough and Priority Review of NRX-101 in treatment of bipolar depression in people at risk of akathisia, based on the Phase 2b/3 and STABIL-B data. Three manufacturing lots are now completed with more than 12 months of room temperature shelf-stability. The anticipated PDUFA date for this application is prior to June 30, 2025;

 

 

 

The Company additionally plans to file an NDA in Q4 2024 for Approval under Fast Track Designation and Priority Review for NRX-100 (preservative-free sterile ketamine) in a tamper-resistant, diversion resistant packaging presentation. Ketamine efficacy data are in hand from 4 clinical trials. Three manufacturing lots are now completed with 9 months of stability anticipated by October 30, 2024. The anticipated PDUFA date for this settlement is prior to June 30, 2025. The Company believed that the preservative-free feature of this presentation will be deemed of benefit to patients because of the known toxicity of benzanthonium choloride used to preserve the current commercial formulations of ketamine used for anesthesia

 

 

We developed a novel, patentable pH neutral formulation for ketamine (designed as HTX-100) that will be suitable for both intravenous and subcutaneous administration. Initial laboratory lots demonstrate shelf stability and ongoing stability is being assessed. Ketamine in its current commercial presentations cannot be administered subcutaneously because of its high acidic (pH 3.5-4.0) properties, an acidity range that is known to cause paid and skin ulcers;

 

 

We have completed the audit for HOPE, thereby facilitating the proposed Spin-Off. We have partnered with representatives of ketamine clinic operators to construct a care platform that will include ketamine, operational support, and digital therapeutic extensions. In advance of FDA approval, HOPE is supplying ketamine under 503b pharmacy licensure to meet the national ketamine shortage declared by FDA;

 

 

NRX-101 in the treatment of Complicated Urinary Tract Infection (“cUTI”) granted Qualified Infectious Disease Product (“QIDP”), Fast Track, and Priority Review designations. Company has now demonstrated that NRX-101 does not damage the microbiome of the gut, in contrast to all other advanced antibiotics and is less likely to cause C. Difficile infection (a potentially lethal side effect of antibiotic treatment). NRx is reviewing partnership options: and

 

 

Executed Memorandum of Understanding with Foundation FundaMental for rights to develop potential disease modifying drug for schizophrenia. If successful, this would represent the first drug to reverse the underlying disease mechanism of schizophrenia, rather than simply treating symptoms.

 

 

Development of NRX-101 for Suicidal Treatment-Resistant Suicidal Bipolar Depression

 

On May 5, 2024, the Company announced final data from the recently completed phase 2b/3 trial of NRX-101 in suicidal bipolar depression, with a significantly improved safety profile as demonstrated by a statistically significant reduction in akathisia, an adverse event considered by many experts to be a precursor to suicide. Given the vital need for safer medications in this at-risk population, we plan to submit an NDA to the US FDA for treatment of bipolar depression patients at risk of akathisia, based on these data as well as additional data from our STABIL-B trial.

 

nrxp-20240331x10q001.jpg

 

 

Trial participants had identical mean scores on the BARS at baseline with subsequent decrease in the NRX-101 treated group versus an increase in the lurasidone-treated group, yielding a 76% relative mean difference between the groups. The difference was apparent at the first post-randomization visit and continued throughout the trial. (Fig 1) Over the 42 days of observation, an effect size of .37 was identified with a statistically significant P value of 0.025 on the Mixed Model for Repeated Measures methodology agreed to with FDA in the 2018 Special Protocol Agreement. Akathisia as ascertained by a 1 point increase in the BARS was seen in 11% of participants randomized to lurasidone (comparable to previous reports in the literature) and seen in only 2% of those treated with NRX-101, an akathisia level that was previously reported for the placebo arm of the lurasidone registration trial.

 

Akathisia was a prespecified key safety endpoint of the Company’s clinical trial. Hence this finding is not a “post-hoc” observation. As previously noted, this clinical trial of 91 participants with suicidal bipolar depression who were not pre-treated with ketamine demonstrated that NRX-101 and lurasidone were comparable in their antidepressant effect. A 33% but statistically non-significant sustained decrease in suicidality was also seen favoring NRX-101. As noted above, improved antidepressant efficacy is not required to seek drug accelerated drug approval based on a statistically-significant safety benefit.

 

The results released on May 24 are consistent with and amplify the results of the Company’s previously published STABIL-B trial (Fig 2 below). In both trials a meaningful reduction in Akathisia was seen, which was statistically significant in the current trial (P<.025) and near significant (P=0.11) in the STABIL-B with similar effect sizes The STABIL-B additionally demonstrated a statistically-significant reduction in suicidality on the Columbia Suicide Severity Rating Scale (C-SSRS).

 

nrxp-20240331x10q002.jpg

 


1 Nierenberg A, Lavin P, Javitt DC, et. al. NRX-101 vs lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior; a randomized prospective phase 2 trial. Int J Bipolar Dis 2023;11:28-38, doi.org/10.1186/s40345-023-00308-5.

 

 

Reduced suicidality associated with the administration of D-cycloserine has additionally been demonstrated by Chen and Coworkers.

 

Figure 2: Results from published STABIL-B Trial

 

Incorporation of HOPE Therapeutics and progress towards an NDA for HTX-100 (IV ketamine) in the treatment of suicidal depression

 

In Q1 2024, the Company incorporated HOPE Therapeutics as a wholly-owned subsidiary and engaged its auditors who in August 2024 completed an audit of its financial statements which will be necessary for the intended spin-off of HOPE to the Company’s shareholders. Intravenous ketamine has now become a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product. Intranasal Esketamine is approved by the FDA (SPRAVATO®), but has not demonstrated a benefit on suicidality and is not approved for use in patients with bipolar depression. Attempts to use intranasal racemic ketamine for suicidal depression have failed.

 

The Company has formed data-sharing partnerships to license clinical trial data from a French Government-funded trial and two National Institute of Health (NIH)-funded trials all of which demonstrate efficacy of racemic Intravenous ketamine against depression and two of which demonstrate statistically significant benefit vs suicidality. The Company’s role is to reformat these data into the required presentation required for review by the FDA.

 

In contrast to nasal ketamine, Intravenous racemic ketamine demonstrates dramatic and immediate reduction of suicidality in patients with both Major Depressive Disorder and Bipolar Depression. Grunebaum and colleagues demonstrated a rapid and statistically significant reduction in Suicidal Ideation at day 1 (p=0.0003) and in depression (P=0.0234), as measured by the Profile of Mood States among patients randomized to IV Ketamine compared to those randomized to midazolam. This trial was published in the American Journal of Psychiatry . Abbar and colleagues similarly published 84% remission from suicidality on the C-SSRS in patients treated with ketamine, vs. 28% in those treated with placebo (P<.0001). This trial was published in the British Medical Journal. Data are expected to be transmitted to FDA by July 2024.

 

In November 2023, the Company initiated manufacture of ketamine together with Nephron Pharmaceuticals, Inc. to develop a single patient presentation of ketamine. Nine months of real-time stability is expected in June 2024, the minimum stability time required for a New Drug Application.

 

A long-term challenge with ketamine is that the current formulation (KETALAR®) is highly acidic. While it is suitable for intravenous use, it cannot be administered subcutaneously. In March 2024 the Company demonstrated the formulation of a pH neutral patentable form of IV ketamine that it anticipates will have widespread applicability both in treatment of depression and chronic pain.

 

 

Treatment of Urinary Tract Infection (UTI) and Urosepsis:

 

Although treatment of UTI is quite different from use of NRX-101 to treat Central Nervous System disorders, D-cycloserine was originally developed as an antibiotic because of its role in disrupting the cell wall of certain pathogens. During Q3 2023, NRx tested NRX-101 and its components against resistant pathogens that appear on the Congressionally mandated QIDP list and proved in vitro effectiveness against antibiotic-resistant E. coli, Pseudomonas, and Acinetobacter. Accordingly, NRx was granted QIDP designation, Fast Track Designation, and Priority Review by the US FDA in January 2024.

 

In recent years, increased antibiotic resistance to common pathogens that cause urinary tract infections and urosepsis (i.e., sepsis originating in the urinary tract) has resulted in a marked increase in cUTI, hospitalization, and death from urosepsis. The US Center for Disease Control and Prevention reports that more than 1.7 million Americans contract sepsis each year, of whom at least 350,000 die during their hospitalization or are discharged to hospice (CDC Sepsis Ref.). There are approximately three million patients per year who contract cUTI in the U.S. annually (Lodise, et. al.). Additionally, should NRX-101 succeed in clinical trials, the Company will consider developing a follow-on product that is anticipated to achieve another 20 years of patent exclusivity.

 

A key challenge in the treatment of cUTI is the tendency of advanced antibiotics to cause C. Difficile infection, which is fatal in 10% of those who contract it over the age of 65 and results in prolonged hospitalization in many more. The Company recently announced data demonstrating that NRX-101 does not compromise the intestinal microbiome, unlike common antibiotics including Clindamycin and Ciprofloxacin. Should these findings be documented in human patients, NRX-101 would represent the only treatment for cUTI that does not cause C. Difficile infection.

 

Recent Developments

 

Reverse Stock Split

 

On March 28, 2024, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment to the Company’s Second Amended and Restated Certificate of Incorporation (the “Charter Amendment”) to effect a 1-for-10 reverse stock split (the “Reverse Stock Split”) of the Company’s Common Stock, par value $0.001 per share (the “Common Stock”), which Reverse Stock Split was effective April 1, 2024. All references in this Report to number of common shares, price per share and weighted average number of shares outstanding have been adjusted to reflect the Reverse Split on a retroactive basis.

 

April 2024 Offering

 

On April 18, 2024, we entered into the April Underwriting Agreement with EF Hutton LLC, as the representative of the April Underwriters, relating to the April Offering of 607,000 shares of the Company’s Common Stock. The public offering price for each share of Common Stock was $3.30. On April 19, 2024, the Offering closed. Aggregated proceeds from the Public Offering were approximately $2.4 million (including April Overallotment Exercise proceeds), before deducting underwriting discounts and commission and estimated expenses payable by the Company

 

Pursuant to the April Underwriting Agreement and the engagement letter dated April 18, 2024, by and between the Company and Representative, 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 Shares and any April Option Shares (as defined below) sold, at an initial exercise price of $3.63 per share, subject to certain adjustments (the “April Underwriter's Warrant”). On April 19, 2024, the Company issued to the Representative the April Underwriter's Warrant to purchase up to 30,350 shares of Common Stock. The April Underwriter's Warrants and Over-Allotment Warrants is exercisable six months following the date of the Underwriting Agreement and terminates on the five-year anniversary of the date of the April Underwriting Agreement. 

 

Pursuant to the April Underwriting Agreement, the Company also granted the Representative a 45-day Over-Allotment Option to purchase up to an additional 91,050 April Option Shares. In connection with the April Overallotment Exercise, we issued an additional April Underwriter's Warrant to purchase up to 4,553 shares of Common Stock. The April Overallotment Exercise was exercised in full and closed. 

 

 

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. Though June 30, 2024, the Company received aggregate net cash proceeds to the Company from the ATM Purchases Agreements were approximately $1.4 million. Subsequent to June 30, 2024, the Company sold additional shares of Common Stock at an aggregate sales price of $0.3 million.

 

February 2024 Offerings

 

On February 27, 2024, we entered into the February Underwriting Agreement with the Representative (as defined above), as the representative of the February Underwriters (as defined above), relating to the February 2024 Public Offering (as defined above) of 500,000 shares of the Common Stock. The public offering price for each share of Common Stock was $3.00, and the February Underwriters purchased the shares of Common Stock pursuant to the February Underwriting Agreement at a price for each share of Common Stock of $2.76. On February 28, 2024, the Offering closed. Aggregate gross proceeds from the February 2024 Public Offering were approximately $1.7 million (including Overallotment Exercise proceeds), before deducting underwriting discounts and commissions and estimated expenses payable by the Company.

 

Pursuant to the February Underwriting Agreement and the engagement letter, dated as of February 22, 2024, by and between the Company and the Representative, the Company agreed to issue to the Representative in connection with the February 2024 Public Offering, a warrant to purchase up to a number of shares of Common Stock representing 5.0% of the shares of Common Stock and any February Option Shares (as defined below) sold, at an initial exercise price of $3.30 per share, subject to certain adjustments (the “February Underwriters Warrant”). On February 28, 2024, the Company issued to the Representative the February Underwriter’s Warrant to purchase up to 25,000 shares of Common Stock. The February Underwriter’s Warrant is exercisable six months following the date of the February Underwriting Agreement and terminates on the five-year anniversary of the date of the February Underwriting Agreement.

 

Pursuant to the February Underwriting Agreement, the Company also granted the Representative a 45-day Over-Allotment Option to purchase up to an additional 75,000 February Option Shares. On March 5, 2024, the February Underwriters exercised the February Over-Allotment Option to purchase an additional 75,000 February Option Shares. In connection with the February Overallotment Exercise, we issued an additional February Underwriter’s Warrant to purchase up to 3,750 shares of Common Stock. The February Overallotment Exercise closed on March 6, 2024.

 

On February 29, 2024, we 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 at a price of $3.80 per share of Common Stock and accompanying warrant, which represents a 26.7% premium to the offering price in the February 2024 Public Offering. The Common Stock and the February Warrants were offered pursuant to a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The February Warrants will have an exercise price of $3.80 per share, are initially exercisable beginning six months following the date of issuance, and will expire 5 years from the date of issuance. The aggregate net cash proceeds to the Company from the February 2024 Private Placement (as defined above) were approximately $1.0 million.

 

 

Financial Results

 

Since inception, the Company has incurred significant operating losses. For the three months ended June 30, 2024 and 2023, the Company’s net loss was $7.9 million and $8.7 million, respectively. For the six months ended June 30, 2024 and 2023, the Company’s net loss was $14.4 million and $19.8 million, respectively. As of June 30, 2024, the Company had an accumulated deficit of $267.6 million, a stockholders’ deficit of $18.4 million and a working capital deficit of $18.8 million.

 

Going Concern

 

The Company has now secured operating capital that it anticipates as sufficient to fund its drug development operations through year end and to finance submission of FDA New Drug Applications for NRX-100 and NRX-101 in 2024. The Company may 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. 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 regarding 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 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.

 

Nasdaq Listing Compliance

 

Following a notice of deficiency on October 17, 2023 and a subsequent Reverse Stock Split on April 17, 2024, as previously disclosed, we received a written notice from Nasdaq informing the Company that it has regained compliance for continued listing on the Nasdaq Capital Market. Subsequent to the end of the period, on August 6, 2024, the Company received a notice of deficiency from the Nasdaq based on current failure to meet the required Market Value of Listed Securities as disclosed in an 8-K filing on August 12, 2024. The Company has a six month period in which to cure this deficiency or to apply for an extension.

 

Components of Results of Operations

 

Research and development expense

 

The Company’s research and development expense consists primarily of costs associated with the Company’s 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 expense

 

General and administrative expenses consist primarily of salaries, stock-based compensation, consultant fees, and professional fees for legal and accounting services.

 

 

Results of operations for the three months ended June 30, 2024 and 2023

 

The following table sets forth the Company’s selected statements of operations data for the following periods (in thousands):

 

   

Three months ended June 30,

   

Change

 
   

2024

   

2023

   

Dollars

 
   

(Unaudited)

         

Operating expense:

                       

Research and development

  $ 2,804     $ 3,873     $ (1,069 )

General and administrative

    4,246       4,065       181  

Settlement Expense

          250       (250 )

Total operating expense

    7,050       8,188       (1,138 )

Loss from operations

  $ (7,050 )   $ (8,188 )   $ 1,138  
                         

Other (income) expense:

                       

Interest income

  $ (7 )   $ (145 )   $ 138  

Convertible note default penalty

    849             849  

Change in fair value of convertible note payable

    23       663       (640 )

Change in fair value of warrant liabilities

    (18 )     11       (29 )

Total other (income) expense

    847       529       318  

Loss before tax

    (7,897 )     (8,717 )     820  

Net loss

  $ (7,897 )   $ (8,717 )   $ 820  

 

Operating expense

 

Research and development expense

 

For the three months ended June 30, 2024, the Company recorded $2.8 million of research and development expense compared to approximately $3.9 million for the three months ended June 30, 2023. The decrease of $1.1 million is related primarily to a decrease of $2.4 million in clinical trials and development expense, $0.1 million in shipping, freight, and delivery, $0.2 million in other regulatory and process development costs, and less than $0.1 million related to stock-based compensation, partially offset by a increase of $1.3 million related to the Alvogen warrants and $0.4 million related to fees paid to regulatory and process development consultants. The research and development expense for the three months ended June 30, 2024 and 2023, respectively, includes less than $0.1 million and $0.1 million, respectively of non-cash stock-based compensation. 

 

General and administrative expense

 

For the three months ended June 30, 2024, the Company recorded $4.2 million of general and administrative expense compared to approximately $4.1 million for the three months ended June 30, 2023. The increase of $0.1 million is related primarily to an increase of $0.9 million in consultant fees, $0.7 million in legal expense, partially offset by a decrease of $0.8 million in insurance expense, $0.4 million in stock-based compensation expense, and $0.3 million in employee expenses. The general and administrative expense for the three months ended June 30, 2024 and 2023, respectively, includes $0.1 million and $0.4 million, respectively, of non-cash stock-based compensation.

 

Other (income) expense

 

Interest income

 

For the three months ended June 30, 2024, the Company recorded less than $0.1 million of interest income compared to $0.1 million of interest income for the three months ended June 30, 2023. The decrease of less than  $0.1 million is due to interest earned in the Company’s money market account.

 

Convertible note default penalty

 

For the three months ended June 30, 2024, the Company recorded $0.8 million of a default penalty compared to no default penalty for the three months ended June 30, 2023. The increase is due to alleged default in connection with the convertible note.

 

Change in fair value of convertible note payable

 

For three months ended June 30, 2024, the Company recorded a loss of less than $0.1 million related to the change in fair value of the convertible note payable which is accounted for under the fair value option. For the three months ended June 30, 2023, the Company recorded a loss of approximately $0.7 million related to the change in fair value of the convertible note payable which is accounted for under the fair value option.

 

Change in fair value of warrant liabilities

 

The change in fair value of warrant liabilities reflects the changes in the carrying value of our liability-classified warrants (see Note 9 and Note 11).

 

 

Results of operations for the six months ended June 30, 2024 and 2023

 

The following table sets forth the Company’s selected statements of operations data for the following periods (in thousands):

 

   

Six months ended June 30,

   

Change

 
   

2024

   

2023

   

Dollars

 
   

(Unaudited)

         

Operating expense:

                       

Research and development

  $ 4,552     $ 7,523     $ (2,971 )

General and administrative

    8,496       9,850       (1,354 )

Settlement Expense

          250       (250 )

Total operating expense

    13,048       17,623       (4,575 )

Loss from operations

  $ (13,048 )   $ (17,623 )   $ 4,575  
                         

Other (income) expense:

                       

Interest income

  $ (34 )   $ (301 )   $ 267  

Interest expense

    230             230  

Convertible note default penalty

    849             849  

Change in fair value of convertible note payable

    341       2,435       (2,094 )

Change in fair value of warrant liabilities

    (9 )     (1 )     (8 )

Total other (income) expense

    1,377       2,133       (756 )

Loss before tax

    (14,425 )     (19,756 )     5,331  

Net loss

  $ (14,425 )   $ (19,756 )   $ 5,331  

 

Operating expense

 

Research and development expense

 

For the six months ended June 30, 2024, the Company recorded $4.6 million of research and development expense compared to approximately $7.5 million for the six months ended June 30, 2023. The decrease of $2.9 million is related primarily to a decrease of $4.1 million in clinical trials and development expense, $0.3 million in other regulatory and process development costs,  $0.1 million in shipping, freight, and delivery, less than $0.1 million related to stock-based compensation, partially offset by an increase in $1.3 related to Alvogen warrants and $0.4 million related to fees paid to regulatory and process development consultants. The research and development expense for the six months ended June 30, 2024 and 2023 includes less than $0.1 million and $0.2 million, respectively, of non-cash stock-based compensation.

 

General and administrative expense

 

For the six months ended June 30, 2024, the Company recorded $8.5 million of general and administrative expense compared to approximately $9.9 million for the six months ended June 30, 2023. The decrease of $1.4 million is related primarily to a decrease of $2.0 million in insurance expense, $0.8 million in employee expense, $0.8 million in stock-based compensation expense, and less than $0.1 million in patent expense, partially offset by an increase of $1.3 million in consultant fees, $0.7 million in legal expense, and $0.2 million in other general and administrative expense. The general and administrative expense for the six months ended June 30, 2024 and 2023, respectively, includes $0.3 million and $1.0 million, respectively, of non-cash stock-based compensation.

 

Other (income) expense

 

Interest income

 

For the six months ended June 30, 2024, the Company recorded less than $0.1 million of interest income compared to $0.3 million of interest income for the six months ended June 30, 2023. The decrease of $0.2 million is due to interest earned in the Company’s money market account.

 

 

Interest expense

 

For the six months ended June 30, 2024, the Company recorded $0.2 million of interest expense, compared to no interest expense for the six months ended June 30, 2023. The increase of $0.2 million is due to premiums for cash payments on the convertible note.

 

Convertible note default penalty

 

For the six months ended June 30, 2024, the Company recorded $0.8 million of a default penalty compared to no default penalty for the six months ended June 30, 2023. The increase is due to alleged default in connection with the convertible note.

 

Change in fair value of convertible note payable

 

For six months ended June 30, 2024, the Company recorded a loss of $0.3 million related to the change in fair value of the convertible note payable which is accounted for under the fair value option. For the six months ended June 30, 2023, the Company recorded a loss of approximately $2.4 million related to the change in fair value of the convertible note payable which is accounted for under the fair value option.

 

Change in fair value of warrant liabilities

 

The change in fair value of warrant liabilities reflects the changes in the carrying value of our liability-classified warrants (see Note 9 and Note 11).

 

Liquidity and Capital Resources

 

The Company has generated no revenues, has incurred operating losses since inception, expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. Until such time as the Company is able to establish a revenue stream from the sale of its therapeutic products, it is dependent upon obtaining necessary equity and/or debt financing to continue operations. The Company cannot make any assurances that sales of NRX-101 will commence in the near term or that additional financings will be available to it on acceptable terms or at all. This could negatively impact our business and operations and could also lead to the reduction of our operations.

 

April 2024 Offering

 

On April 18, 2024, we entered into the April Underwriting Agreement with the Representative, as the representative of the April Underwriters, relating to the April Offering of the Shares, which April Offering closed on the April Closing Date. The public offering price for each share of Common Stock was $3.30. Pursuant to the April Underwriting Agreement, the Company also granted the Representative the April Over-Allotment Option. Aggregated gross proceeds from the April Underwriting Agreement were approximately $2.4 million (including April Overallotment Exercise proceeds), before deducting and commissions and estimated expenses payable by the Company. The Company intends to use the net proceeds from the April 2024 Public Offering for working capital and general corporate purposes.

 

On May 23, 2024, the Underwriters in the April 2024 Public Offering exercised their April Over-Allotment Option to purchase an additional 91,050 April Option Shares. In connection with the April Overallotment Exercise, we issued an additional April Underwriter Warrant to purchase up to 4,553 shares of Common Stock. The April Overallotment was exercised in full and closed on May 23, 2024. 

 

 

 

February 2024 Offerings

 

On February 27, 2024, the Company entered into an February Underwriting Agreement (as defined above) with EF Hutton LLC, as the Representative (as defined above) of the February Underwriters (as defined above), relating to the February 2024 Public Offering. The public offering price for each share of Common Stock was $3.00 and the February Underwriters purchased the shares of Common Stock pursuant to the February Underwriting Agreement at a price for each share of Common Stock of $2.76. Pursuant to the February Underwriting Agreement, the Company also granted the Representative the February Over-Allotment Option. Aggregate gross proceeds from the February Underwriting Agreement were approximately $1.7 million (including February Overallotment Exercise proceeds), before deducting underwriting discounts and commissions and estimated expenses payable by the Company. The Company intends to use the net proceeds from the February 2024 Public Offering for working capital and general corporate purposes. The Company also used the proceeds from February 2024 Public Offering to repay the Convertible Promissory Note initially issued to Streeterville Capital, LLC in November 2022.

 

On March 5, 2024, the Underwriters in the February 2024 Public Offering exercised their February Over-Allotment Option to purchase an additional 75,000 February Option Shares. In connection with the February Overallotment Exercise, we issued an additional February Underwriter’s Warrant to purchase up to 3,750 shares of Common Stock. The February Overallotment Exercise closed on March 6, 2024.

 

On February 29, 2024, the Company completed the February 2024 Private Placement. Pursuant to the securities purchase agreement, the Company issued and sold 270,000 shares of Common Stock and warrants to purchase up to 270,000 shares of Common Stock at a price of $3.80 per share of Common Stock and accompanying warrant, which represents a 26.7% premium to the offering price in February 2024 Public Offering. The common stock and the February Warrants were offered pursuant to a private placement under Section 4(a)(2) of the Securities Act. The February Warrants will have an exercise price of $3.80 per share, are initially exercisable beginning six months following the date of issuance, and will expire 5 years from the date of issuance. The aggregate net cash proceeds to the Company from the February 2024 Private Placement were approximately $1.0 million.

 

Cash Flows

 

The following table presents selected financial information and statistics for each of the periods shown below:

 

   

June 30, 2024

   

December 31, 2023

 

Balance Sheet Data:

               

Cash

  $ 1,898     $ 4,595  

Total assets

    5,264       7,315  

Convertible note payable

    7,651       9,161  

Total liabilities

    23,655       19,048  

Total stockholders' deficit

    (18,391 )     (11,733 )

 

   

June 30,

 
   

2024

   

2023

 
   

(Unaudited)

 

Statement of Cash Flow Data:

               

Net cash used in operating activities

  $ (6,233 )   $ (13,901 )

Net cash used in investing activities

          (2 )

Net cash provided by financing activities

    3,536       8,818  

Net decrease in cash

  $ (2,697 )   $ (5,085 )

 

 

Operating activities

 

During the six months ended June 30, 2024, operating activities used approximately $6.2 million of cash, primarily resulting from a net loss of $14.4 million partially offset by (a) net non-cash losses of $2.9 million, including $0.3 million in change in fair value of convertible promissory note, and $0.3 million of stock-based compensation, $1.3 million of contract costs related to Alvogen termination, $0.8 million of default penalties, and (b) changes in operating assets and liabilities of $5.3 million.

 

During the six months ended June 30, 2023, operating activities used $13.9 million of cash, primarily resulting from a net loss of $19.8 million, reduced by (a) net non-cash losses of $3.9 million, including $2.4 million in change in fair value of convertible promissory note and $1.2 million of stock-based compensation, and (b) changes in operating assets and liabilities of $1.9 million.

 

Financing activities

 

During the six months ended June 30, 2024, financing activities provided $3.5 million of cash resulting from $1.0 million in proceeds from issuance of Common Stock and warrants issued in a private placement, and $4.7 million in proceeds from issuance of Common Stock and warrants offset by $2.2 million in repayments of the convertible note.

 

During the six months ended June 30, 2023, financing activities provided $8.8 million of cash resulting from $8.1 million in proceeds from issuance of common stock and warrants issued in a private placement, net of issuance costs, and $0.8 million in proceeds from proceeds from issuance of insurance loan offset by $0.1 million in repayments of the convertible note.

 

Contractual Obligations and Commitments

 

See Note 7, Debt, and Note 8, Commitments and Contingencies, of the notes to the Company’s condensed consolidated financial statements as of and for the six months ended June 30, 2024 included elsewhere in this report for further discussion of the Company’s commitments and contingencies.

 

Milestone Payments

 

Pursuant to the legal settlement with Sarah Herzog Memorial Hospital Ezrat Nashim (“SHMH”) in September 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.

 

Off-Balance Sheet Arrangements

 

The Company is not party to any off-balance sheet transactions. The Company has no guarantees or obligations other than those which arise out of normal business operations.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

The Company's 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 generally accepted accounting principles in the United States of America (“GAAP”). The preparation of these financial statements requires the Company 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, the Company evaluates its estimates and judgments on an ongoing basis. The most significant estimates relate to the stock-based compensation, the valuation of warrants, and the fair value of a note payable. The Company bases its estimates and assumptions on current facts, historical experiences, and various other factors that the Company 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.

 

 

The Company 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 which the Company applies those principles. While its significant accounting policies are more fully described in Note 3 to its financial statements, the Company believes the following are the critical accounting policies used in the preparation of its financial statements that require significant estimates and judgments.

 

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. For restricted stock awards, the grant date fair value is the fair market value per share as of the grant date based on the closing trading price for the Company’s stock. 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 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 the U.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 liabilities

 

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 the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 480, Distinguishing Liabilities from Equity (“ASC 480”) and FASB ASC Topic 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, or date of modification, 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 was estimated using a Black Scholes valuation approach and the fair value of the Substitute Warrants was estimated using a modified Black Scholes valuation approach which applies a probability factor based on the earnout cash milestone and earnout shares milestone probabilities of achievement at each reporting period.

 

 

Convertible note payable

 

As permitted under FASB ASC Topic 825, Financial Instruments (“ASC 825”), the Company elects to account for its convertible promissory note, which meets the required criteria, at fair value at inception and at each subsequent reporting date. Subsequent changes in fair value are recorded as a component of non-operating loss in the consolidated statements of operations. As a result of electing the fair value option, direct costs and fees related to the convertible promissory notes are expensed as incurred.

 

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 our Common Stock and estimates for the equity volatility and volume volatility of its Common Stock, the time to expiration(i.e. expected termination date) 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 equity and volume volatility based on the historical volatility of both 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. For the year ended December 31, 2023, the probability of default was estimated using Bloomberg’s Default Risk function which uses its financial information to calculate a default risk specific to the Company. For the six months ended June 30, 2024, the probability of default was estimated based on discussions with management, the Company's current cash balance, and the Company's current efforts to receive financing to repay the Note or amend the agreement.

 

The assumptions used in determining the fair value of the convertible note payable represent reasonable estimates, but the estimates involve inherent uncertainties and the application of our judgment. As a result, if factors change and the Company’s uses significantly different assumptions or estimates, the change in fair value of the convertible note payable recorded to other (income) expense could be materially different in the future.

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

As a smaller reporting company, we are not required to provide the information required by this Item.

 

 

Item 4. Controls and Procedures

 

(a) Evaluation of Disclosure Controls and Procedures

 

We maintain “disclosure controls and procedures,” as such term is defined under Rule 13a-15(e) promulgated under the Exchange Act, designed to ensure that information required to be disclosed in our reports filed pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate to allow timely decisions regarding required disclosures.

 

In designing and evaluating the disclosure controls and procedures, we recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and we were required to apply our judgment in evaluating the cost-benefit relationship of possible controls and procedures. We have carried out an evaluation as of June 30, 2024 under the supervision, and with the participation, of our management, including our Chief Executive Officer (who serves as our principal executive officer) and our Chief Financial Officer (who serves as our principal financial officer), of the effectiveness of the design and operation of our disclosure controls and procedures.

 

Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2024 in providing reasonable assurance of achieving the desired control objectives.  

 

 

(b) Changes in Internal Control Over Financial Reporting

 

There were no changes in the Company’s internal controls over financial reporting that occurred during the three months ended June 30, 2024 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company continues to review its disclosure controls and procedures, including its internal control over financial reporting, and may from time to time make changes aimed at enhancing their effectiveness and to ensure that the Company’s systems evolve with its business.

 

 

PART II OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

See Note 8, Commitments and Contingencies, of the notes to the Company’s unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2024 included elsewhere in this report for further discussion of certain legal proceedings in which we are involved.

 

Item 1A. Risk Factors

 

We have disclosed the risk factors that materially affect our business, financial condition or results of operations under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 29, 2024 (the “Annual Report on Form 10-K”). There have been no material changes from the risk factors previously disclosed. You should carefully consider the risk factors set forth in the Annual Report on Form 10-K and other information set forth elsewhere in this Quarterly Report on Form 10-Q. You should be aware that these risk factors and other information may not describe every risk that we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial, or may not be able to assess, also may materially adversely affect our business, financial condition and/or operating results.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults Upon Senior Securities

 

No defaults upon senior securities occurred during the three months ended June 30, 2024, that were not previously reported.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

 

Item 5. Other Information

 

None of our directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2024, as such terms are defined under Item 408(a) of Regulation S-K. Additionally, we did not adopt or terminate a Rule 10b5–1 trading arrangement during the quarter ended June 30, 2024.

 

40

 

 

Item 6. Exhibits

 

Exhibit Number

 

Description

 

Incorporation by Reference

         

1.1

 

Underwriting Agreement, dated April 18, 2024, by and between NRx Pharmaceuticals, Inc. and EF Hutton LLC,

 

Exhibit 1.1 to the Current Report on Form 8-K, filed on April 19, 2024

         

4.1

 

Form of Underwriter’s Warrant between NRx Pharmaceuticals, Inc. issued April 19, 2024.

 

Exhibit 4.1 to the Current Report on Form 8-K, filed on April 19, 2024

         

31.1+

 

Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

   
         

31.2+

 

Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

   
         

32.1+†

 

Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

   
         

32.2+†

 

Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

   
         

99.1

 

Notice by Streeterville Capital, LLC.

 

Exhibit 99.1 to the Current Report on Form 8-K, filed on April 30, 2024

         

101*

 

Interactive data files pursuant to Rule 405 of Regulation S-T formatted in Inline XBRL: (i) Condensed Consolidated Balance Sheets as of June 30, 2024 (Unaudited) and December 31, 2023; (ii) Unaudited Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2024 and 2023 ; (iii) Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) for the three and six months ended June 30, 2024 and 2023; (iv) Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023; and (v) Notes to Unaudited Financial Statements.

   
         

104

 

Cover Page Interactive Data File (formatted in iXBRL and contained in Exhibit 101)

   

 

 

+

Filed herewith.

This certification is being furnished solely to accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

*

In accordance with Rule 406T of Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q is deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act, is deemed not filed for purposes of section 18 of the Exchange Act, and otherwise is not subject to liability under these sections.

 

 

SIGNATURES

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

   

NRX PHARMACEUTICALS, INC.

     

Date: August 14, 2024

 

By:

/s/ Richard Narido

     

Richard Narido

     

Chief Financial Officer (Principal Financial Officer)

 

42

Exhibit 31.1

CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER

PURSUANT TO RULE 13a-14(a) AND 15d-14(a),

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Stephen H. Willard, Chief Executive Officer of NRx Pharmaceuticals, Inc., certify that:

 

1.

I have reviewed this Quarterly Report on Form 10-Q of NRx Pharmaceuticals, Inc. (the “Registrant”);

 

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Quarterly Report;

 

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the Registrant as of, and for, the periods presented in this Quarterly Report;

 

 

4.

The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

 

 

a.

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant is made known to us by others within those entities, particularly during the period in which this Quarterly Report is being prepared;

     
 

b.

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

     
 

c.

Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

     
 

d.

Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

 

5.

The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing equivalent functions):

 

 

a.

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and

     
 

b.

Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

 

Date: August 14, 2024

/s/ Stephen H. Willard

 

Stephen H. Willard

 

Chief Executive Officer (Principal Executive Officer)

 

 

Exhibit 31.2

CERTIFICATION OF THE ACTING CHIEF FINANCIAL OFFICER

PURSUANT TO RULE 13a-14(a) AND 15d-14(a),

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Richard Narido, Chief Financial Officer of NRx Pharmaceuticals, Inc., certify that:

 

1.

I have reviewed this Quarterly Report on Form 10-Q of NRx Pharmaceuticals, Inc. (the “Registrant”);

 

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Quarterly Report;

   

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the Registrant as of, and for, the periods presented in this Quarterly Report;

   

4.

The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

 

 

a.

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant is made known to us by others within those entities, particularly during the period in which this Quarterly Report is being prepared;

     
 

b.

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

     
 

c.

Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

     
 

d.

Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

 

5.

The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing equivalent functions):

 

 

a.

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and

     
 

b.

Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

 

Date: August 14, 2024

/s/ Richard Narido

 

Richard Narido

 

Chief Financial Officer (Principal Financial Officer)

 

 

Exhibit 32.1

CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the filing of the Quarterly Report on Form 10-Q for the three months ended June 30, 2024 (the “Report”) by NRx Pharmaceuticals, Inc. (the “Registrant”), I, Stephen H. Willard, as Chief Executive Officer of the Registrant hereby certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

 

 

1.

the Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and

 

 

2.

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.

 

Date: August 14, 2024

/s/ Stephen H. Willard

 

Stephen H. Willard

 

Chief Executive Officer (Principal Executive Officer)

 

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to the Registrant and will be retained by the Registrant and furnished to the Securities and Exchange Commission or its staff upon request

 

 

Exhibit 32.2

CERTIFICATION OF THE ACTING CHIEF FINANCIAL OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the filing of the Quarterly Report on Form 10-Q for the three months ended June 30, 2024 (the “Report”) by NRx Pharmaceuticals, Inc. (the “Registrant”), I, Richard Narido, as Chief Financial Officer of the Registrant hereby certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

 

 

1.

the Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and

 

 

2.

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.

 

Date: August 14, 2024

/s/ Richard Narido

 

Richard Narido

 

Chief Financial Officer (Principal Financial Officer)

 

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to the Registrant and will be retained by the Registrant and furnished to the Securities and Exchange Commission or its staff upon request.

 

 
v3.24.2.u1
Document And Entity Information - shares
6 Months Ended
Jun. 30, 2024
Aug. 14, 2024
Document Information [Line Items]    
Entity Central Index Key 0001719406  
Entity Registrant Name NRX Pharmaceuticals, Inc.  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2024  
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Jun. 30, 2024  
Document Transition Report false  
Entity File Number 001-38302  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 82-2844431  
Entity Address, Address Line One 1201 Orange Street, 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   10,894,693
Warrant [Member]    
Document Information [Line Items]    
Title of 12(b) Security Warrants to purchase Common Stock  
Trading Symbol NRXPW  
Security Exchange Name NASDAQ  
Common Stock [Member]    
Document Information [Line Items]    
Title of 12(b) Security Common Stock, par value $0.001 per share  
Trading Symbol NRXP  
Security Exchange Name NASDAQ  
v3.24.2.u1
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
ASSETS    
Cash and cash equivalents $ 1,898 $ 4,595
Prepaid expense and other current assets 2,982 2,289
Total current assets 4,880 6,884
Other assets 384 431
Total assets 5,264 7,315
LIABILITIES AND STOCKHOLDERS’ DEFICIT    
Accounts payable 5,015 4,632
Accrued and other current liabilities 9,594 4,714
Accrued clinical site costs 444 524
Convertible note payable and accrued interest 7,651 9,161
Insurance loan payable 943 0
Warrant liabilities (Note 9) 8 17
Total liabilities 23,655 19,048
Commitments and Contingencies (Note 8)
Common stock, $0.001 par value, 500,000,000 shares authorized; 10,791,630 and 8,391,940 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively 11 8
Additional paid-in capital 249,173 241,406
Accumulated other comprehensive loss (3) (3)
Accumulated deficit (267,572) (253,147)
Total stockholders’ deficit (18,391) (11,733)
Total liabilities and stockholders' deficit 5,264 7,315
Nondesignated Preferred Stock [Member]    
LIABILITIES AND STOCKHOLDERS’ DEFICIT    
Preferred stock, $0.001 par value, 50,000,000 shares authorized. 0 0
Series A Convertible Preferred Stock [Member]    
LIABILITIES AND STOCKHOLDERS’ DEFICIT    
Preferred stock, $0.001 par value, 50,000,000 shares authorized. $ 0 $ 3
v3.24.2.u1
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares
Jun. 30, 2024
Dec. 31, 2023
Preferred stock, par value (in dollars per share) $ 0.001  
Preferred stock, authorized (in shares) 50,000,000  
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, authorized (in shares) 500,000,000 500,000,000
Common stock, issued (in shares) 10,791,630 8,391,940
Common stock, outstanding (in shares) 10,791,630 8,391,940
Nondesignated Preferred Stock [Member]    
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, authorized (in shares) 50,000,000 50,000,000
Series A Convertible Preferred Stock [Member]    
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, authorized (in shares) 12,000,000 12,000,000
Preferred stock, issued (in shares) 0 3,000,000
Preferred stock, outstanding (in shares) 0 3,000,000
v3.24.2.u1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Operating expense:        
Research and development $ 2,804 $ 3,873 $ 4,552 $ 7,523
General and administrative 4,246 4,065 8,496 9,850
Settlement expense 0 250 0 250
Total operating expenses 7,050 8,188 13,048 17,623
Loss from operations (7,050) (8,188) (13,048) (17,623)
Other (income) expense:        
Interest income (7) (145) (34) (301)
Interest expense 0 0 230 0
Convertible note default penalty 849 0 849 0
Change in fair value of convertible note payable 23 663 341 2,435
Change in fair value of warrant liabilities (18) 11 (9) (1)
Total other expense 847 529 1,377 2,133
Net loss (7,897) (8,717) (14,425) (19,756)
Comprehensive loss:        
Change in fair value of convertible note attributed to credit risk 0 128 0 22
Other comprehensive loss 0 128 0 22
Comprehensive loss $ (7,897) $ (8,845) $ (14,425) $ (19,778)
Net loss per share:        
Basic and diluted (in dollars per share) $ (0.75) $ (1.21) $ (1.49) $ (2.81)
Weighted average common shares outstanding:        
Basic and diluted (in shares) 10,517,460 7,322,156 9,684,873 7,026,062
v3.24.2.u1
Condensed Consolidated Statements of Changes in Stockholders' (Deficit) Equity (Unaudited) - USD ($)
$ in Thousands
Common Stock and Warrant Issuance [Member]
Preferred Stock [Member]
Series A Preferred Stock [Member]
Common Stock and Warrant Issuance [Member]
Preferred Stock [Member]
Common Stock and Warrant Issuance [Member]
Common Stock [Member]
Common Stock and Warrant Issuance [Member]
Additional Paid-in Capital [Member]
Common Stock and Warrant Issuance [Member]
Retained Earnings [Member]
Common Stock and Warrant Issuance [Member]
AOCI Attributable to Parent [Member]
Common Stock and Warrant Issuance [Member]
ATM Offering [Member]
Preferred Stock [Member]
Series A Preferred Stock [Member]
ATM Offering [Member]
Preferred Stock [Member]
ATM Offering [Member]
Common Stock [Member]
ATM Offering [Member]
Additional Paid-in Capital [Member]
ATM Offering [Member]
Retained Earnings [Member]
ATM Offering [Member]
AOCI Attributable to Parent [Member]
ATM Offering [Member]
Private Placement [Member]
Preferred Stock [Member]
Series A Preferred Stock [Member]
Private Placement [Member]
Preferred Stock [Member]
Private Placement [Member]
Common Stock [Member]
Private Placement [Member]
Additional Paid-in Capital [Member]
Private Placement [Member]
Retained Earnings [Member]
Private Placement [Member]
AOCI Attributable to Parent [Member]
Private Placement [Member]
Preferred Stock [Member]
Series A Preferred Stock [Member]
Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
AOCI Attributable to Parent [Member]
Total
Balance (in shares) at Dec. 31, 2022                                           0 0 6,644,299        
Balance at Dec. 31, 2022                                           $ 0 $ 0 $ 7 $ 230,399 $ (222,997) $ 0 $ 7,409
Stock-based compensation                                           0 0 0 695 0 0 695
Stock issuances, net (in shares) 0 0 386,667                                                  
Stock issuances, net $ 0 $ 0 $ 0 $ 2,545 $ 0 $ 0 $ 2,545                                          
Net loss                                           $ 0 $ 0 $ 0 0 (11,039) 0 (11,039)
Balance (in shares) at Mar. 31, 2023                                           0 0 7,030,966        
Balance at Mar. 31, 2023                                           $ 0 $ 0 $ 7 233,639 (234,036) 106 (284)
Change in fair value of convertible note attributed to credit risk                                           $ 0 $ 0 $ 0 0 0 106 106
Balance (in shares) at Dec. 31, 2022                                           0 0 6,644,299        
Balance at Dec. 31, 2022                                           $ 0 $ 0 $ 7 230,399 (222,997) 0 7,409
Net loss                                                       (19,756)
Balance (in shares) at Jun. 30, 2023                                           0 0 8,038,833        
Balance at Jun. 30, 2023                                           $ 0 $ 0 $ 8 239,959 (242,753) (22) (2,808)
Change in fair value of convertible note attributed to credit risk                                                       (22)
Balance (in shares) at Mar. 31, 2023                                           0 0 7,030,966        
Balance at Mar. 31, 2023                                           $ 0 $ 0 $ 7 233,639 (234,036) 106 (284)
Stock-based compensation                                           $ 0 $ 0 $ 0 544 0 0 544
Stock issuances, net (in shares) 0 0 967,000                                                  
Stock issuances, net $ 0 $ 0 $ 1 5,576 0 0 5,577                                          
Shares issued as repayment of principal and interest for convertible note (in shares)                                           0 0 40,867        
Shares issued as repayment of principal and interest for convertible note                                           $ 0 $ 0 $ 0 200 0 0 200
Net loss                                           $ 0 $ 0 $ 0 0 (8,717) 0 (8,717)
Balance (in shares) at Jun. 30, 2023                                           0 0 8,038,833        
Balance at Jun. 30, 2023                                           $ 0 $ 0 $ 8 239,959 (242,753) (22) (2,808)
Change in fair value of convertible note attributed to credit risk                                           $ 0 $ 0 $ 0 0 0 (128) (128)
Balance (in shares) at Dec. 31, 2023                                           3,000,000 0 8,391,940        
Balance at Dec. 31, 2023                                           $ 3 $ 0 $ 8 241,406 (253,147) (3) (11,733)
Stock-based compensation                                           $ 0 $ 0 $ 0 242 0 0 242
Conversion of Series A preferred stock into common stock (in shares)                                             0 300,000        
Conversion of Series A preferred stock into common stock                                             $ 0 $ 0 3 0 0 0
Conversion of Series A preferred stock into common stock (in shares)                                           (3,000,000)            
Conversion of Series A preferred stock into common stock                                           $ (3)            
Stock issuances, net (in shares) 0 0 575,000         0 0 34,584         0 0 270,000                      
Stock issuances, net $ 0 $ 0 $ 1 1,343 0 1,344 $ 0 $ 0 $ 0 $ 179 $ 0 $ 0 $ 179 $ 0 $ 0 $ 0 $ 1,027 $ 0 $ 0 $ 1,027              
Warrants issued pursuant to the Alvogen Agreement amendment (see Note 6)                                           $ 0 $ 0 $ 0 0 0 0 0
Vesting of restricted stock awards (in shares)                                           0 0 57,500        
Vesting of restricted stock awards                                           $ 0 $ 0 $ 0 0 0 0 0
Shares issued as repayment of principal and interest for convertible note (in shares)                                           0 0 143,648        
Shares issued as repayment of principal and interest for convertible note                                           $ 0 $ 0 $ 1 399 0 0 400
Net loss                                           $ 0 $ 0 $ 0 0 (6,528) 0 (6,528)
Balance (in shares) at Mar. 31, 2024                                           0 0 9,772,672        
Balance at Mar. 31, 2024                                           $ 0 $ 0 $ 10 244,599 (259,675) (3) (15,069)
Balance (in shares) at Dec. 31, 2023                                           3,000,000 0 8,391,940        
Balance at Dec. 31, 2023                                           $ 3 $ 0 $ 8 241,406 (253,147) (3) (11,733)
Net loss                                                       (14,425)
Balance (in shares) at Jun. 30, 2024                                           0 0 10,791,630        
Balance at Jun. 30, 2024                                           $ 0 $ 0 $ 11 249,173 (267,572) (3) (18,391)
Change in fair value of convertible note attributed to credit risk                                                       0
Balance (in shares) at Mar. 31, 2024                                           0 0 9,772,672        
Balance at Mar. 31, 2024                                           $ 0 $ 0 $ 10 244,599 (259,675) (3) (15,069)
Stock-based compensation                                           0 0 0 97 0 0 97
Stock issuances, net (in shares) 0 0 698,050         0 0 247,868                                    
Stock issuances, net $ 0 $ 0 $ 1 $ 1,913 $ 0 $ 0 $ 1,914 $ 0 $ 0 $ 0 $ 1,228 $ 0 $ 0 $ 1,228                            
Net loss                                           $ 0 $ 0 $ 0 0 (7,897) 0 (7,897)
Issuance of shares related to reverse stock split (in shares)                                           0 0 73,040        
Contract cost related to Alvogen termination (see Note 6)                                           $ 0 $ 0 $ 0 1,336 0 0 1,336
Balance (in shares) at Jun. 30, 2024                                           0 0 10,791,630        
Balance at Jun. 30, 2024                                           $ 0 $ 0 $ 11 $ 249,173 $ (267,572) $ (3) (18,391)
Change in fair value of convertible note attributed to credit risk                                                       $ 0
v3.24.2.u1
Condensed Consolidated Statements of Changes in Stockholders' (Deficit) Equity (Unaudited) (Parentheticals) - USD ($)
$ in Thousands
3 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Common Stock and Warrant Issuance [Member]        
Offering costs $ 494 $ 481 $ 2,168 $ 351
ATM Offering [Member]        
Offering costs $ 118 $ 48    
v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:    
Net loss $ (14,425) $ (19,756)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation expense 2 2
Stock-based compensation 339 1,239
Change in fair value of warrant liabilities (9) (1)
Change in fair value of convertible note payable 341 2,435
Warrant issuance costs related to Alvogen termination 1,336 0
Convertible note default penalty 849 0
Non-cash settlement expense 0 250
Changes in operating assets and liabilities:    
Prepaid expense and other assets (648) 922
Accounts payable 4,209 129
Insurance loan payable 943 0
Accrued expense and other liabilities 830 879
Net cash used in operating activities (6,233) (13,901)
CASH FLOWS FROM INVESTING ACTIVITIES    
Purchase of computer equipment 0 (2)
Net cash used in investing activities 0 (2)
CASH FLOWS FROM FINANCING ACTIVITIES    
Repayment of convertible note (2,156) (90)
Proceeds from issuance of insurance loan 0 786
Proceeds from issuance of common stock and warrants, net of issuance costs 4,665 0
Proceeds from issuance of common stock and warrants issued in private placement, net of issuance costs 1,027 8,122
Net cash provided by financing activities 3,536 8,818
Net decrease in cash and cash equivalents (2,697) (5,085)
Cash and cash equivalents at beginning of period 4,595 20,054
Cash and cash equivalents at end of period 1,898 14,969
Supplemental disclosure of cash flow information:    
Cash paid for interest 374 205
Cash paid for taxes 0 0
Non-cash investing and financing activities    
Issuance of common stock warrants as offering costs 188 75
Conversion of Series A Preferred Stock to Common stock [Member]    
Non-cash investing and financing activities    
Conversion of Series A preferred stock into common stock 3 0
Conversion of Principal and Interest Into Common Stock [Member]    
Non-cash investing and financing activities    
Issuance of common stock as principal and interest repayment for convertible notes $ 400 $ 200
v3.24.2.u1
Note 1 - Organization
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]

1. Organization

 

The Business

 

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRX” or the Company”) is a clinical-stage bio-pharmaceutical company which develops and intends to 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 post-traumatic stress disorder (“PTSD”) and now schizophrenia. All of our current drug development activities are focused drugs that modulate 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. The Company has two lead drug candidates that are expected to be submitted by year end for Food and Drug Administration (“FDA”) approval with anticipated FDA decision dates under the Prescription Drug User Fee Act ("PDUFA") by the end of June 2025: NRX-101, an oral fixed dose combination of D-cycloserine and lurasidone and NRX-100, a preservative-free formulation of ketamine for intravenous infusion. In February 2024, the Company incorporated HOPE as a wholly-owned subsidiary and in August 2024 completed a carve-out audit of HOPE's financial statements which are necessary for the intended Spin-Off (as defined in Note 7) of HOPE to the Company's shareholders at a future date.

 

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 to the development of intravenous ketamine (NRX-100/HTX-100) for the treatment of suicidal depression. 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.

 

v3.24.2.u1
Note 2 - Going Concern
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Substantial Doubt about Going Concern [Text Block]

2. Going Concern

 

Since inception, the Company has experienced net losses and negative cash flows from operations each fiscal year and has a working capital deficit at June 30, 2024. The Company has no revenues and expects to continue to incur operating losses for the remainder of 2024. Although the Company projects operating income to be derived from the operation of clinical facilities through its HOPE subsidiary and sales of its pharmaceutical products in 2025, these projections are subject to completion of anticipated clinical acquisitions in the first case and regulatory approvals in the latter case. In the absence of these projected developments, the Company’s ability to support its ongoing capital needs is dependent on its ability to continue to raise equity and/or debt financing, which may not be available on favorable terms, or at all, in order to continue operations.

 

As of June 30, 2024, the Company had $1.9 million in cash and cash equivalents. Subsequently, on August 12, 2024, the Company signed an agreement with Anson Funds for $16.3 million in Senior Secured Debt financing. Concurrently, the Company signed a settlement agreement with Streeterville Capital, LLC to retire its remaining debt for a settlement amount of $5.6 million and to settle outstanding litigation. This settlement amount was substantially less than the amounts claimed by Streeterville in litigation. 

 

The Company has now secured operating capital that it anticipates as sufficient to fund its drug development operations through year end and to finance submission of FDA New Drug Applications for NRX-100 and NRX-101 in 2024. The Company may 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. 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 regarding 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 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.

 

v3.24.2.u1
Note 3 - Summary of Significant Accounting Policies
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Significant Accounting Policies [Text Block]

 

3. Summary of Significant Accounting Policies

 

On April 1, 2024, the Company effected a reverse stock split (the “Reverse Stock Split”) of the Company’s common stock, $0.001 par value (“Common Stock”), at a ratio of 1-for-10. All historical share amounts, with the exception of the Company’s Series A Preferred Stock, disclosed in this Quarterly Report on Form 10-Q have been retroactively adjusted to reflect the Reverse Stock Split. No fractional shares were issued as a result of the Reverse Stock Split, as fractional shares of Common Stock were rounded up to the nearest whole share. See Note 9. Equity for additional information.

 

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”), provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the 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 June 30, 2024 the Company’s cash and cash equivalents balance within money market accounts was in excess of the U.S. federally insured limits by $1.3 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”) or other accounting standards for revenue not derived from customers. Arrangements may include licenses to intellectual property, research services and participation on joint research committees. The Company evaluates the promised goods or services to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, the Company considers the stage of research, the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property, and whether the promised goods or services are integral to or dependent on other promises in the contract. 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 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”) with Alvogen Pharma US, Inc., Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (collectively, “Alvogen”) (as further discussed in Note 6 below) was accounted for in accordance with ASC 606. In 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 may 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 incurred research costs in association with the License Agreement. After the First Milestone Payment (as defined in Note 6 below), the Company would have been reimbursed for certain costs incurred related to reasonable and documented out-of-pocket costs for clinical and non-clinical development activities. The Company would have recognized revenue for the reimbursed costs when the First Milestone Payment contingencies had been achieved and the Company had an enforceable claim to the reimbursed costs.

 

Research and Development Costs

 

Research and development expense consists 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.

 

Convertible Note Payable and Fair Value Election

 

As permitted under FASB ASC Topic 825, Financial Instruments (“ASC 825”), the Company elected to account for its promissory note, which meets the required criteria, at fair value at inception. Subsequent changes in fair value are recorded as a component of non-operating loss in the consolidated statements of operations. The portion of total changes in fair value of the note attributable to changes in instrument-specific credit risk are determined through specific measurement of periodic changes in the discount rate assumption exclusive of base market changes and are presented as a component of comprehensive income in the accompanying condensed consolidated statements of operations and comprehensive loss. As a result of electing the fair value option, direct costs and fees related to the promissory notes are expensed as incurred.

 

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. For the valuation as of  December 31, 2023, the probability of default was estimated using Bloomberg’s Default Risk function which uses its financial information to calculate a default risk specific to the Company. For the valuation as of  June 30, 2024, the probability of default was based on management's estimates which include, the Company's current cash runway, current efforts to raise financing, and current economic environment. 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”) and FASB ASC Topic 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 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 Entitys Own Equity, the Series A Preferred Stock did not meet any of the criteria that would preclude equity classification. The Company concluded that the Series A Preferred Stock was more akin to an equity-type instrument than a debt-type instrument, therefore the conversion features associated with the convertible preferred stock were deemed to be clearly and closely related to the host instrument and were not bifurcated as a derivative under ASC 815.

 

 

Income Taxes

 

Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the 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. 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.

 

  

Six months ended June 30,

 
  

2024

  

2023

 

Stock options

  161,437   254,885 

Restricted stock awards

  66,666   100,000 

Common stock warrants

  4,069,240   3,002,159 

  

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 six months ended June 30, 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.

 

 

v3.24.2.u1
Note 4 - Prepaid Expense and Other Current Assets
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Prepaid Expenses and Other Current Assets [Text Block]

4. Prepaid Expense and Other Current Assets

 

Prepaid expense and other current assets consisted of the following at the dates indicated (in thousands):

 

   

June 30, 2024

   

December 31, 2023

 
   

(Unaudited)

         

Prepaid expense and other current assets:

               

Prepaid insurance

  $ 1,500     $ 1,078  

Prepaid clinical development costs

    830       871  

Other prepaid expense

    646       334  

Other current receivables

    6       6  

Total prepaid expense and other current assets

  $ 2,982     $ 2,289  

 

v3.24.2.u1
Note 5 - Accrued and Other Current Liabilities
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block]

5. Accrued and Other Current Liabilities

 

Accrued and other current liabilities consisted of the following at the dates indicated (in thousands):

 

   

June 30, 2024

   

December 31, 2023

 
   

(Unaudited)

         

Accrued and other current liabilities:

               

Refund liability (see Note 6)

  $ 3,826     $  

Professional services

    3,593       2,686  

Accrued employee costs

    1,062       835  

Accrued research and development expense

    900       1,112  

Other accrued expense

    213       81  

Total accrued and other current liabilities

  $ 9,594     $ 4,714  

 

v3.24.2.u1
Note 6 - Alvogen Licensing Agreement
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Collaborative Arrangement Disclosure [Text Block]

6. Alvogen Licensing Agreement 

 

In June 2023, the Company entered into a License Agreement with Alvogen. Under the License Agreement, the Company granted Alvogen certain license rights to develop, manufacture, and commercialize the Company’s candidate therapeutic product, NRX-101, for the treatment of bipolar depression with suicidality. In exchange for the license granted and the participation of the Company in certain development, regulatory and commercial activities, Alvogen was obligated to pay the Company specified regulatory and commercial milestones, the first of which was $9 million 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”). In February 2024, the parties executed an amendment accelerating payment of up to $5 million related to the First Milestone Payment, with the remaining $4 million due upon the original agreement’s terms (see below for advances received through June 30, 2024). As compensation for advancing the milestone, Alvogen received warrants to purchase up to 419,598 shares of the Company's Common Stock, at a strike price of $4.00 with a three year term (See Note 9). The grant date fair value of the warrants was approximately $1.3 million, which the Company planned to account for as consideration paid to a customer (see below). The second portion of the first milestone was to be $4 million and, as before, triggered by a positive response to the Company's planned end of phase 2 meeting with FDA. If the first milestone was not achieved by September 3, 2024, the Company would be obligated to repay any amount received against the $5 million advance of the First Milestone Payment to Alvogen. As there was significant uncertainty relative to approval of any drug candidate in development, the Company concluded that it was not probable that a significant reversal of revenue would 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 was fully constrained and advances from Alvogen were recorded as a refund liability until such time as the refund right expired. Further, the Company accounted for the warrants issued to Alvogen within additional paid-in capital consistent with the accounting for unfunded stock subscription agreements until such time as the uncertainty around the First Milestone was resolved.  

 

Termination 

 

Under the License Agreement, as amended, Alvogen was granted early termination rights. On June 21, 2024, the Company received a notice of termination from Alvogen effective immediately. Following the termination of the License Agreement by Alvogen, the amounts advanced pursuant to the amendment became due and payable to Alvogen. Accordingly, the refund liability has not been reclassified as deferred revenue or recorded as revenue as of June 30, 2024.

 

Upon termination of the License Agreement, the intellectual property rights licensed to Alvogen under the License Agreement reverted to the Company, and all other rights and obligations of each of the parties immediately ceased, except for outstanding amounts owed as of the time of such expiration or termination. As of June 30, 2024, the refund liability due to Alvogen was $3.8 million, which represent all payments made by Alvogen through June 30, 2024, and is included as a component of accrued expense and other current liabilities on the condensed consolidated balance sheet. Following the early termination by Alvogen, the Company does not anticipate recognizing any revenue under the License Agreement. Additionally, the Company wrote-off the unfunded stock subscription receivable of $1.3 million related to the warrants previously classified in additional paid-in capital to research and development expense following the termination. 

 

 

 

v3.24.2.u1
Note 7 - Debt
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Debt Disclosure [Text Block]

7. Debt

 

Convertible Note

 

On November 4, 2022, the Company issued an 9% redeemable promissory note (as amended, the “Note”) to Streeterville Capital, LLC, a Utah limited liability company (“Streeterville”), for an aggregate principal amount of $11.0 million. The Note originally matured 18 months from the date of issuance subject to certain acceleration provisions. The Note carries an original issue discount of $1.0 million which was deducted from the principal balance of the Note. The net proceeds from the issuance of the Note was $10.0 million after transaction costs including the original issue discount, legal and other fees are included.

 

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”). Payments may be made by the Company at their option in: (i) in cash with a 10% premium (the “Redemption Premium”) for the amount redeemed, (ii) by paying the redemption amount in the form of shares of Common Stock with the number of redemption shares being equal to the portion of the applicable redemption amount divided by the Redemption Conversion Price (as defined below), or (iii) a combination of cash and shares of Common Stock. The “Redemption Conversion Price” on any given redemption date equals 85% multiplied by the average of the two lowest daily volume weighted average prices per share of the Common Stock during the ten trading days immediately preceding the date that the noteholder delivers notice electing to redeem a portion of the Note. Beginning May 1, 2023, in the event (a) the daily dollar trading volume of the Common Stock of the Company on any given trading day is at least fifty percent (50%) greater than the lower of (i) the median daily dollar trading volume over the previous ten (10) trading days or (ii) the daily dollar trading volume on the trading day immediately preceding the date of measurement or (b) if the closing trade price on any given trading day is at least thirty percent (30%) greater than the Nasdaq Minimum Price, then the lender will be entitled to redeem over the following ten (10) trading days an amount of indebtedness then outstanding under the Note equal to twice the monthly redemption amount of $1.0 million solely by payment by stock, if permitted under the agreement, subject to the Maximum Percentage (as defined in the Note) and other ownership limitations.

 

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 Note (such event, an “Event of Default”). Upon an Event of a Default, the Lender may consider the Note immediately due and payable. Upon an Event of Default, the interest rate may also be increased to the lesser of 18% per annum or the maximum rate permitted under applicable law (see below). 

 

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”), pursuant to which the Maximum Percentage was set at 9.99% of the number of shares of Common Stock outstanding on a given date.

 

On July 7, 2023, the Company entered into Amendment #2 to the Note with Streeterville (the “Second Amendment”). Pursuant to the Second Amendment, the Company agreed to amend the redemption provisions of the Note to provide that the Company would pay to Streeterville an amount in cash equal to $1.8 million on or before July 10, 2023, which amount was paid on July 10, 2023. In addition, the Company agreed that, beginning on or before July 31, 2023, and on or before the last day of each month until December 31, 2023 (the Company would pay Streeterville an amount equal to $0.4 million in cash), less any amount satisfied by the delivery of Redemption Conversion Shares (as defined below). Notwithstanding the foregoing, Streeterville may also submit a request for redemption of up to an aggregate of $1.0 million per month in 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”), with Streeterville. In accordance with the Third Amendment, the Company and Streeterville agreed to amend the redemption provisions of the Note to provide that the Company would pay to Streeterville an amount in cash equal to $1.1 million on February 12, 2024, which the amount was paid on February 12, 2024. In addition, beginning on or before February 29, 2024, and on or before the last day of each month until July 31, 2024, the Company shall pay Streeterville an amount equal to $0.4 million in cash, less any amount satisfied by the delivery of Redemption Conversion Shares. During the first three months of this amended payment period, Streeterville may not request to redeem amounts greater than $0.4 million per month.

 

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. As a result of the alleged Event of Default mentioned below, the Company did not pay any Redemption Amounts during the three months ended June 30, 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”) calculated on the basis of the Redemption Conversion Price (as defined in the Note) without regard to the existence of an Equity Conditions Failure. Moreover, the Redemption Premium (as defined in the Note) will continue to apply to the Redemption Amounts.

 

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 Note 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 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 and six months ended June 30, 2024, the Company recorded a loss from the change in fair value of the Note of less than $0.1 million and $0.3 million, respectively, which was recognized in other (income) expense on the condensed consolidated statements of operations as a result of the Company’s election of the fair value option. For the three and six months ended June 30, 2023, the Company recorded a loss from the change in fair value of the Note of $0.7 million and $2.4 million, respectively, which was recognized in other (income) expense on the condensed consolidated statements of operations as a result of the Company’s election of the fair value option.

 

During the three and six months ended June 30, 2024, the Company made cash payments for coupon interest on the Note of approximately $0.1 million, and $0.2 million of redemption premiums, issued shares of Common Stock as coupon interest repayment of $0.1 million, and incurred a default penalty of $0.8 million. During the three and six months ended June 30, 2023, the Company made interest payments on the Note of approximately $0.1 million and issued shares of Common Stock as principal and interest repayments on the Note of $0.2 million.

 

 

As of June 30, 2024, and December 31, 2023, the Note carried a remaining principal balance of $6.5 million and $8.3 million, respectively. Refer to Note 11 for the reconciliation of the fair values for the periods presented.

 

Alleged Default

 

On April 24, 2024, the Company received written notice from counsel for Streeterville that an alleged event of default occurred with respect to Note issued by the Company in favor of Streeterville (the “Notice”). The Notice alleges that, among other things, (i) the announcement of the plan to partially spin-off of HOPE (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 in 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, resulting in the acceleration of all of the outstanding amounts due thereunder.

 

Streeterville also 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 Common Stock or other equity securities (such as the shares of HOPE 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 $6,537,027, or the amounts currently outstanding under the Note.

 

On July 29, 2024, in connection with the alleged Event of Default that Streeterville claimed occurred with respect to the Note, the Company announced an order of the Utah arbitrator denying the petition of Streeterville to enjoin Spin-Off of 49% of shares in HOPE to current shareholders of the Company. The purpose of the proposed Spin-Off was to provide the Company’s shareholders with valuable consideration and to provide HOPE (currently a wholly-owned subsidiary) with a sufficient shareholder base to enable future listing on a a national exchange. The arbitrator also denied Streeterville’s petition to enjoin the Company from selling additional shares of Common Stock to finance ongoing operations (see Note 14).

v3.24.2.u1
Note 8 - Commitments and Contingencies
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Commitments and Contingencies Disclosure [Text Block]

8. Commitments and Contingencies

 

Sarah Herzog Memorial Hospital License Agreement

 

The Company is required to make certain payments related to the development of NRX-101 (the "Licensed Product") in order to maintain the license agreement with the Sarah Herzog Memorial Hospital Ezrat Nashim (“SHMH”) (the "SHMH License Agreement"), including:

 

Milestone Payments

 

End of Phase I Clinical Trials of Licensed Product (completed)

 $100,000 

End of Phase II Clinical Trials of Licensed Product (completed)

 $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 and six months ended June 30, 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. During the three and six months ended June 30, 2023, no royalty payments were made.

 

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 and six months ended June 30, 2024 and 2023, the Company has recorded no expenses relating to the licensure of the patent. 

 

 

Legal Proceedings

 

 

The Company is a defendant in litigation filed by Streeterville in the Third Judicial District Court of Salt Lake County, Utah. See Note 7, Debt, for additional information. The Complaint seeks, among other things: (i) declaratory relief for an order enjoining the Company from undertaking any Fundamental Transaction, including the Spin-Off, or otherwise issuing Common Stock or other equity securities (such as the shares of HOPE 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 $6,537,027, or the amounts currently outstanding under the Note.

 

 

On July 29, 2024, in connection with the alleged Event of Default that Streeterville claimed occurred with respect to the Note, the Company announced an order of the Utah arbitrator denying the petition of Streeterville to enjoin the planned Spin-Off of 49% of shares in HOPE to current shareholders of the Company. The purpose of the proposed Spin-Off was to provide the Company’s shareholders with valuable consideration and to provide HOPE (currently a wholly-owned subsidiary) with a sufficient shareholder base to enable future listing on a a national exchange. The arbitrator also denied Streeterville’s petition to enjoin the Company from selling additional shares of Common Stock to finance ongoing operations. This matter was settled subsequent to June 30, 2024.

 

On August 12, 2024, the Company signed a settlement agreement with Streeterville to retire its remaining debt for a settlement amount of $5.6 million and to settle outstanding litigation. This settlement amount was substantially less than the amounts claimed by Streeterville in its Compliant (see Note 14).

 

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, other than as set forth above, 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.

 

v3.24.2.u1
Note 9 - Equity
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Equity [Text Block]

9. Equity

 

Common Stock Reverse Stock Split

 

On March 21, 2024, the Board approved a reverse stock split ratio of 1-for-10. On March 28, 2024, the Company filed an amendment to its certificate of incorporation in the State of Delaware (the “Amendment”), which provided that, effective as of 4:30 p.m. Eastern Standard Time on April 1, 2024 (the “Effective Time”), every ten shares of its issued and outstanding Common Stock will automatically be combined into one issued and outstanding share of Common Stock, without any change in the par value per share.

 

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. As a result of the Reverse Stock Split, 73,040 additional shares of common stock were issued in lieu of fractional shares. 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 ("Series A Preferred"). In August 2023, the Company sold and issued 3.0 million shares of Series A Preferred for an aggregate cash purchase price of $1.2 million. During March 2024 holders of the Company’s Series A Preferred elected to convert 3,000,000 shares of Series A Preferred into 300,000 shares of Common Stock. As of June 30, 2024, no shares of Series A Preferred 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 Common Stock 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 April 15, 2024, the Company announced that it entered into multiple purchase agreements (the “ATM Purchase Agreements”) subject to standard closing conditions where accredited investors purchased 282,452 shares of unregistered Common Stock at a range of  $4.643 – $7.10 per share. 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. Through June 30, 2024, the aggregate net cash proceeds to the Company from the ATM Purchases Agreements were approximately $1.4 million.

 

 

 

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”) at a price of $3.80 per share of Common Stock and accompanying warrant, which represents a 26.7% premium to the offering price in February 2024 Public Offering. The Common Stock and the February Warrants were offered pursuant to a private placement (the “ February 2024 Private Placement”) under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The aggregate net cash proceeds to the Company from the February 2024 Private Placement were approximately $1.0 million. As of June 30, 2024, the shares of Common Stock had not been issued.

 

On February 27, 2024, the Company entered into an underwriting agreement (the “ February Underwriting Agreement”) with EF Hutton LLC (the “Representative”), as the representative of the several underwriters named therein (the “ February Underwriters”), relating to an underwritten public offering (the “ February 2024 Public Offering”) of 500,000 shares (the “ February Shares”) of the Company’s Common Stock. The public offering price for each share of Common Stock was $3.00 and the February Underwriters purchased the shares of Common Stock pursuant to the February Underwriting Agreement at a price for each share of Common Stock of $2.76. Pursuant to the February Underwriting Agreement, the Company also granted the Representative a 45-day option to purchase up to an additional 75,000 shares (the “ February Option Shares”) of the Common Stock on the same terms as the February Shares sold in the February 2024 Public Offering (the “ February Over-Allotment Option”). On February 28, 2024, the February 2024 Public Offering closed (the “ February Closing Date”). The aggregate net cash proceeds to the Company from the February 2024 Offering proceeds were approximately $1.3 million after offering costs of approximately $0.4 million. On March 5, 2024, the February Underwriters of the previously announced underwritten public offering of the Company exercised their option in accordance with the February Underwriting Agreement, dated February 27, 2024, by and between the Company and the Representative, as representative of the several underwriters named therein, to purchase up to an additional 75,000 shares of the Company’s Common Stock, at a public offering price of $3.00 per share (the “ February Overallotment Exercise”). The February Overallotment Exercise closed on March 6, 2024. The aggregate net cash proceeds to the Company from the February Overallotment Exercise were approximately $0.2 million. The Company accrued additional offering costs of approximately $0.2 million.

 

On April 18, 2024, the Company entered into an underwriting agreement (the “ April Underwriting Agreement”) with the Representative, as the representative of the several underwriters named therein (the “ April Underwriters”), relating to an underwritten public offering (the “ April 2024 Public Offering”) of 607,000 shares (the “April Shares”) of Common Stock. The public offering price for each share of Common Stock was $3.30. Pursuant to the April Underwriting Agreement, the Company also granted the Representative a 45-day option to purchase up to an additional 91,050 shares (the “ April Option Shares”) of the Common Stock on the same terms as the April Shares sold in the April 2024 Public Offering (the “ April Over-Allotment Option”). On April 19, 2024, the Offering closed (the “ April Closing Date”). Net proceeds from the April 2024 Public Offering were approximately $1.6 million after offering costs of approximately $0.4 million. On May 23, 2024, the April Underwriters of the previously announced underwritten public offering of the Company exercised their option in accordance with the April Underwriting Agreement, dated April 18, 2024, by and between the Company and the Representative, as representative of the several underwriters named therein, to purchase up to an additional 91,050 shares of the Company’s Common Stock, at the public offering price of $3.30 per share (the “ April Overallotment Exercise”). The April Over-Allotment Exercise was exercised in full and closed on May 23, 2024. The net cash proceeds to the Company from the April Overallotment Exercise were approximately $0.2 million which include offering costs of less than $0.1 million.

 

Common Stock Warrants

 

Substitute Warrants

 

In connection with the Merger in 2021, each warrant to purchase shares of Common Stock of NRx that was outstanding and unexercised immediately prior to the effective time (whether vested or unvested) was assumed by Big Rock Partners Acquisition Corp. ("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”). There were 3,792,970 warrants outstanding and unexercised at the effective time. As these Substitute Warrants meet the definition of a derivative as contemplated in FASB ASC Topic 815, based on provisions in the warrant agreement related to the Earnout Shares Milestone and the Earnout Cash Milestone and the contingent right to receive additional shares for these provisions, the Substitute Warrants were recorded as derivative liabilities on the consolidated balance sheet and measured at fair value at inception (on the date of the Merger) and at each reporting date in accordance with FASB ASC Topic 820, with changes in fair value recognized in the statements of operations in the period of change. 

 

The Company recognized a loss on the change in fair value of the Substitute Warrants for the three months ended  June 30, 2024 and 2023 of less than $0.1 million and less than $0.1 million, respectively. The Company recognized a gain on the change in fair value of the Substitute Warrants for the six months ended June 30, 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 warrants outstanding (the “Public Warrants”) to purchase up to 345,000 shares of Common Stock. Each Public Warrant entitles the holder to purchase one-tenth share of Common Stock at an exercise price of $115 per share. The Public Warrants became exercisable at the effective time of the Merger and expire five years after the effective time on or earlier upon their redemption or liquidation of the Company.

 

During the three and six months ended June 30, 2024 and 2023 no Public Warrants were exercised. The outstanding balance of these public warrants remains in equity. At June 30, 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 FASB ASC Topic 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 June 30, 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 on the change in fair value of the Private Placement Warrants for the three months ended June 30, 2024 and 2023 of less than $0.1 million and less than $0.1 million, respectively. The Company recognized a loss on the change in fair value of the Private Placement Warrants for the six months ended June 30, 2024 and 2023 of less than $0.1 million and 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 270,000 shares of the Company’s Common Stock, the Company issued  February Warrants to purchase up to 270,000 shares of Common Stock which were classified in stockholder’s equity. The February Warrants have an exercise price of $3.80 per share, are initially exercisable beginning six months following the date of issuance, and will expire five years from the date of issuance. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.59, exercise price of $3.80, term of 5 years, volatility of 178.10%, risk-free rate of 4.26%, and expected dividend rate of 0%). The allocated fair value of the February Warrants on the grant date was $0.5 million and is recorded within additional paid-in capital.

 

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”). The Underwriter’s Warrant is exercisable six months following the date of the Underwriting Agreement and terminates on the five-year anniversary of the date of the Underwriting Agreement. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.05, exercise price of $3.30, term of 5 years, volatility of 178.10%, risk-free rate of 4.26%, and expected dividend rate of 0%). The allocated fair value of the Underwriter's Warrants on the grant date was $0.1 million and is recorded as a charge to additional paid-in capital.

 

On March 5, 2024 the Company issued Underwriter’s Warrant to purchase up to 3,750 shares of Common Stock in relation to the exercise of the February Over-Allotment Option. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.05, exercise price of $3.30, term of 5 years, volatility of 178.10%, risk-free rate of 4.12%, and expected dividend rate of 0%). The allocated fair value of the Underwriter's Warrants on the grant date was less than $0.1 million and is recorded as a charge to additional paid-in capital.

 

On April 19, 2024, the Company issued to the Representative the April Underwriter’s Warrant to purchase up to 30,350 shares of Common Stock (the “ April Underwriter Warrant Shares”). The April Underwriter’s Warrant is exercisable six months following the date of the Underwriting Agreement and terminates on the five-year anniversary of the date of the Underwriting Agreement. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.04, exercise price of $3.63, term of 5 years, volatility of 178.10%, risk-free rate of 4.66%, and expected dividend rate of 0%). The allocated fair value of the April Underwriter's Warrant on the grant date was less than $0.1 million and is recorded as a charge to additional paid-in capital.

 

On May 23, 2024 the Company issued Underwriter’s Warrant to purchase up to 4,553 shares of Common Stock in relation to the exercise of the April Over-Allotment Option. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.62, exercise price of $3.63, term of 5 years, volatility of 178.10%, risk-free rate of 4.52%, and expected dividend rate of 0%). The allocated fair value of the Underwriter's Warrants on the grant date was less than $0.1 million and is recorded as a charge to additional paid-in capital.

 

Alvogen Warrants

 

In conjunction with the amended Alvogen licensing agreement discussed in Note 6, on February 7, 2024 the Company issued warrants to purchase up to 419,598 shares of Common Stock. The warrants have an exercise price of $4.00 per share, are exercisable immediately following the date of issuance, will expire three years from the date of issuance, and may also be exercised on a cashless basis if there is no effective registration statement available for the resale of the shares of Common Stock underlying the warrants. The warrants are subject to a beneficial ownership limitation of 4.99% post-exercise, with the exception that the beneficial ownership limitation may be waived up to a maximum of 9.99% at the election of the holder, with not less than 61 days prior notice. The measurement of fair value was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $4.10, exercise price of $4.00, term of 3 years, volatility of 138.0%, risk-free rate of 4.2%, and expected dividend rate of 0.0%). The fair value of the warrants on the grant date was $1.3 million and was recorded within additional paid-in capital as of March 31, 2024. Upon termination of the Alvogen Agreement on June 21, 2024, the offsetting amount recorded within additional paid-in capital as an unfunded stock subscription receivable was expensed to research and development.

 

 

      

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 

Issued

  34,903             

Outstanding as of June 30, 2024

  4,069,240   3.44  $19.47  $ 

 

 

v3.24.2.u1
Note 10 - Stock-based Compensation
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Share-Based Payment Arrangement [Text Block]

10. Stock-Based Compensation

 

2016 Omnibus Incentive Plan

 

Prior to the Merger, NRx maintained its 2016 Omnibus Incentive Plan (the “2016 Plan”), under which NeuroRx granted incentive stock options, restricted stock awards, other stock-based awards, or other cash-based awards to employees, directors, and non-employee consultants. The maximum aggregate shares of Common Stock that were subject to awards and issuable under the 2016 Plan was 347,200.

 

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  June 30, 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”). As of January 1, 2024, 83,920 shares were added to the 2021 Plan under an evergreen feature that automatically increases the reserve with additional shares of Common Stock 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 increased the maximum number of shares (i) available for issuance under the Plan, by an additional 200,000 shares, and (ii) that may be delivered pursuant to the exercise of Incentive Stock Options granted under the Plan to be equal to 100% of the Share Pool. As of June 30, 2024, an aggregate 608,365 shares have been awarded net of forfeitures, and 346,916 shares remain available for issuance under the 2021 Plan. The 2021 Plan permits the granting of incentive stock options, restricted stock awards, other stock-based awards or other cash-based awards to employees, directors, and non-employee consultants.

 

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 or six months ended June 30, 2024.

 

 

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 

Expired/Forfeited

  (14,000)            

Outstanding as of June 30, 2024

  161,437  $21.18   7.5  $ 

Options vested and exercisable as of June 30, 2024

  126,882  $25.18   7.0  $ 

 

Stock-based compensation expense related to stock options was $0.1 million and $0.3 million for the three and six months ended June 30, 2024, respectively.

 

At June 30, 2024, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted, was $0.1 million, which the Company expects to recognize over a weighted-average period of approximately 1.2 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 

Vested

      

Balance as of June 30, 2024 (unvested)

  66,666  $5.66 

 

On July 12, 2022, the Board granted an award of 100,000 restricted shares of the Company (“RSAs”) as an inducement to the newly appointed CEO, pursuant to a separate Restricted Stock Award Agreement. The RSAs will vest in approximately equal installments over three (3) years from the grant date, subject to continued service through the applicable vesting date.

 

On December 28, 2023, the Company was authorized to grant 57,500 RSAs to a consultant for services provided. The RSAs vested after six months from September 4, 2023, the date the services began. The shares were valued on the grant date based on the quoted price of $4.60 or approximately $0.3 million which was amortized over the vesting term.

 

Stock-based compensation expense related to RSAs was less than $0.1 million for the three and six months ended June 30, 2024 respectively.

 

As of June 30, 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 1.0 years.

 

 

The following table summarizes the Company’s recognition of stock-based compensation for the following periods (in thousands):

 

  

Three months ended June 30,

  

Six months ended June 30,

 
  

2024

  

2023

  

2024

  

2023

 
  

(Unaudited)

 

Stock-based compensation expense

                

General and administrative

 $72  $443  $283  $1,034 

Research and development

  25   101   56   205 

Total stock-based compensation expense

 $97  $544  $339  $1,239 

 

v3.24.2.u1
Note 11 - Fair Value Measurements
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Fair Value Disclosures [Text Block]

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 and six months ended June 30, 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 June 30, 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

   

June 30, 2024

   

December 31, 2023

 

Assets:

         

(Unaudited)

         

Money Market Account

    1     $ 475     $ 3,874  
                         

Liabilities:

                       

Warrant liabilities (Note 9)

    3     $ 8     $ 17  

Convertible note payable (Note 7)

    3     $ 7,651     $ 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:

 

   

June 30,

 
   

2024

   

2023

 

Stock price on valuation date

  $ 2.44     $ 4.84  

Time to expiration

    0.17       0.84  

Note market interest rate

    20.6 %     8.9 %

Equity volatility

    145.0 %     100.0 %

Volume volatility

    560.0 %     455.0 %

Risk-free rate

    5.48 %     5.42 %

Probability of default

    50.0 %     6.5 %

 

 

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  

Conversions and repayments of principal and interest (shares and cash)

     

Fair value adjustment through earnings

    23  

Default penalty

    849  

Fair value adjustment through accumulated other comprehensive loss

     

Fair value of the Note as of June 30, 2024

  $ 7,651  
         

Convertible note payable - current portion

  $ 7,651  

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  

Conversions and repayments of principal and interest (shares and cash)

    (288 )

Fair value adjustment through earnings

    665  

Fair value adjustment through accumulated other comprehensive loss

    128  

Fair value of the Note as of June 30, 2023

  $ 12,694  
         

Convertible note payable - current portion

  $ 12,694  

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:

 

   

June 30,

 
   

2024

   

2023

 

Stock price on valuation date

  $ 2.44     $ 6.60  

Exercise price per share

  $ 115.00     $ 115.00  

Expected life

    1.90       3.15  

Volatility

    176.9 %     175.1 %

Risk-free rate

    4.8 %     5.3 %

Dividend yield

    0.0 %     0.0 %

Fair value of warrants

  $ 0.60     $ 7.93  

 

 

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  

Gain upon re-measurement

    (18 )

Balance as of June 30, 2024

  $ 8  

 

Balance as of December 31, 2022

  $ 37  

Gain upon re-measurement

    (12 )

Balance as of March 31, 2023

    25  

Loss upon re-measurement

    11  

Balance as of June 30, 2023

  $ 36  

 

v3.24.2.u1
Note 12 - Income Taxes
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Income Tax Disclosure [Text Block]

12. Income Taxes

 

The Company recorded no provision or benefit for income tax expense for the six months ended June 30, 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 June 30, 2024.

 

 

v3.24.2.u1
Note 13 - Related Party Transactions
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Related Party Transactions Disclosure [Text Block]

13. Related Party Transactions

 

Glytech Agreement

 

The Company licenses patents that are owned by Glytech, LLC (“Glytech”), pursuant to a license agreement (the “Glytech Agreement”). Glytech is owned by Daniel Javitt, a co-founder and former director of the Company. The Glytech Agreement requires that the Company pay Glytech for ongoing scientific support and also reimburse Glytech for expenses of obtaining and maintaining patents that are licensed to the Company. During both the three months ended  June 30, 2024 and 2023, the Company paid Glytech $0.1 million for continuing technology support services and reimbursed expenses. During both the six months ended   June 30, 2024 and 2023, the Company paid Glytech $0.1 million for continuing technology support services and reimbursed expenses. These support services are ongoing. 

 

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”) has an aggregate liquidity value of at least $50 million for twenty (20) consecutive trading days immediately preceding any given date and (ii) there are no legal or contractual restrictions on selling all of the securities represented by the Glytech Equity then applicable to Glytech (or reasonably foreseeable to be applicable to Glytech within the following twenty trading days). The option was not exercised and expired on March 31, 2024.

 

Consulting Agreement with Dr. Jonathan Javitt

 

The Chief Scientist of the Company, Dr. Jonathan Javitt, is a major shareholder in the Company and is the Chairman of the Board of Directors. Therefore, the services provided to the Company 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 and received compensation of $0.2 million and $0.1 million during the three months ended June 30, 2024 and 2023, respectively, and $0.4 million and $0.5 million during the six months ended June 30, 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 provided for payment at the rate of $0.6 million per year, payable monthly (i.e., less than $0.1 million per month), and a performance-based annual bonus with a minimum target of $0.3 million, at the discretion of the Board and upon satisfactory performance of the services. The annual discretionary bonus for 2023, if any, may be approved by the Board in 2024 and is payable in March 2024, will be pro-rated from the start of the extension period and is subject to Dr. Javitt’s continued engagement by the Company. As of June 30, 2024 and December 31, 2023, the annual discretionary bonus of $0.3 million and $0.2 million is accrued and included within accrued and other current liabilities on the condensed consolidated balance sheets, respectively.

 

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 June 30, 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 less than $0.1 million during the three and six months ended June 30, 2024 and 2023, respectively. These services are ongoing.

 

Included in accounts payable were less than $0.1 million due to the above related parties as of  June 30, 2024 and December 31, 2023, respectively.

 

 

 

v3.24.2.u1
Note 14 - Subsequent Event
6 Months Ended
Jun. 30, 2024
Notes to Financial Statements  
Subsequent Events [Text Block]

14. Subsequent Events

 

At-The Market Offering Agreement

 

From July 11, 2024 to July 30, 2024, the Company announced that it entered into multiple purchase agreements (the “ATM Purchase Agreements”) subject to standard closing conditions where accredited investors purchased 103,063 shares of unregistered Common Stock at a range of  $2.421 – $2.528 per share. Subsequent to June 30, 2024, the Company sold additional shares of Common Stock at an aggregate sales price of $0.3 million.

 

Nasdaq Listing Compliance

 

On August 6, 2024, the Company received a letter (the “Letter”) from the Listing Qualifications Staff of The Nasdaq Stock Market, LLC (“Nasdaq”) indicating the from June 14, 2024 to August 5, 2024, the Company's Market Value of Listed Securities (“MVLS”) was below the minimum of $35 million required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the “MVLS Requirement”). In accordance with the Nasdaq Listing Rule 5810(c)(3)(C), the Company has 180 calendar days from the date of the Letter, or through February 3, 2024 to regain compliance with respect to the MVLS Requirement. 

 

Securities Purchase Agreement

 

On August 12, 2024, the Company executed a Securities Purchase Agreement (the “SPA”) and related agreements, under which the Company agreed to sell and issue, and certain purchasers agreed to purchase, an aggregate of $16.3 million of securities. The consideration payable by the purchasers under the SPA will be comprised of three equal closings, each subject to certain closing conditions. The securities to be issued and sold by the Company include up to $16.3 million of senior secured convertible notes (the “Notes”) and warrants to purchase 1.4 million shares of the Company’s common stock (the “Warrants”). The proceeds are expected to be used to settle the Company’s outstanding amounts owed to Streeterville and other working capital needs. The Company has received the first tranche as of the date of this filing.

 

The Notes bear interest at the rate of 6% per annum and mature in 15 months following their date of issuance. The Notes may be settled in cash or in shares of the Company’s common stock, at the sole discretion of the holder, at the applicable conversion price. The Note may not be prepaid by the Company however, the holders of the Note may elect to convert the Notes, in whole or in part, into shares of the Company’s common stock at any time after the original issuance date. The conversion price will equal the lower of (i) $2.4168 or (ii) a price equal to 92% of the lowest volume-weighted average price during the seven-trading day period immediately preceding the applicable conversion date. The Notes include certain redemption, protection features and default interest and penalties. The Notes are secured by all assets of the Company, including its intellectual property.  

 

The Warrants have a term of 5 years, and exercise price of $2.42 and are exercisable immediately upon issuance. The Company is the process of assessing the accounting treatment of the transaction.

 

Settlement Agreement

 

On August 12, 2024 (the “Effective Date”), the Company entered into a settlement agreement and release of claims (the “Agreement”) with Streeterville. Under the terms of the Agreement, the Company will settle the Note for $5.6 million through two installments. The first installment of $2.5 million is due within five days of the Effective Date, and the second installment of $3.1 million is due within 60 days of the Effective date. The Company agreed that it will not complete the Spin-Off, or any similar transaction, until after it has paid the settlement amount in full.

 

 

 

 

v3.24.2.u1
Insider Trading Arrangements
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2024
Insider Trading Arr Line Items    
Material Terms of Trading Arrangement [Text Block]  

Item 5. Other Information

 

None of our directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2024, as such terms are defined under Item 408(a) of Regulation S-K. Additionally, we did not adopt or terminate a Rule 10b5–1 trading arrangement during the quarter ended June 30, 2024.

 

 

Rule 10b5-1 Arrangement Adopted [Flag] false  
Non-Rule 10b5-1 Arrangement Adopted [Flag] false  
Rule 10b5-1 Arrangement Terminated [Flag] false  
Non-Rule 10b5-1 Arrangement Terminated [Flag] false  
v3.24.2.u1
Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Basis of Accounting, Policy [Policy Text Block]

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, Policy [Policy Text Block]

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.

 

Risks and Uncertainties [Policy Text Block]

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, Policy [Policy Text Block]

Fair Value of Financial Instruments

 

FASB ASC Topic 820, Fair Value Measurements (“ASC 820”), provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the 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 Risk, Credit Risk, Policy [Policy Text Block]

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 June 30, 2024 the Company’s cash and cash equivalents balance within money market accounts was in excess of the U.S. federally insured limits by $1.3 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, Policy [Policy Text Block]

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 from Contract with Customer [Policy Text Block]

Revenue Recognition 

 

The Company accounts for revenue under FASB ASC Topic 606, Revenue for Contract with Customers (“ASC 606”) or other accounting standards for revenue not derived from customers. Arrangements may include licenses to intellectual property, research services and participation on joint research committees. The Company evaluates the promised goods or services to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, the Company considers the stage of research, the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property, and whether the promised goods or services are integral to or dependent on other promises in the contract. 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 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”) with Alvogen Pharma US, Inc., Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (collectively, “Alvogen”) (as further discussed in Note 6 below) was accounted for in accordance with ASC 606. In 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 may 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 incurred research costs in association with the License Agreement. After the First Milestone Payment (as defined in Note 6 below), the Company would have been reimbursed for certain costs incurred related to reasonable and documented out-of-pocket costs for clinical and non-clinical development activities. The Company would have recognized revenue for the reimbursed costs when the First Milestone Payment contingencies had been achieved and the Company had an enforceable claim to the reimbursed costs.

 

Research and Development Expense, Policy [Policy Text Block]

Research and Development Costs

 

Research and development expense consists 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.

 

Deferred Charges, Policy [Policy Text Block]

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.

 

Debt, Policy [Policy Text Block]

Convertible Note Payable and Fair Value Election

 

As permitted under FASB ASC Topic 825, Financial Instruments (“ASC 825”), the Company elected to account for its promissory note, which meets the required criteria, at fair value at inception. Subsequent changes in fair value are recorded as a component of non-operating loss in the consolidated statements of operations. The portion of total changes in fair value of the note attributable to changes in instrument-specific credit risk are determined through specific measurement of periodic changes in the discount rate assumption exclusive of base market changes and are presented as a component of comprehensive income in the accompanying condensed consolidated statements of operations and comprehensive loss. As a result of electing the fair value option, direct costs and fees related to the promissory notes are expensed as incurred.

 

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. For the valuation as of  December 31, 2023, the probability of default was estimated using Bloomberg’s Default Risk function which uses its financial information to calculate a default risk specific to the Company. For the valuation as of  June 30, 2024, the probability of default was based on management's estimates which include, the Company's current cash runway, current efforts to raise financing, and current economic environment. 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.

 

Share-Based Payment Arrangement [Policy Text Block]

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.

 

Derivatives, Policy [Policy Text Block]

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”) and FASB ASC Topic 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 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.

 

Stockholders' Equity, Policy [Policy Text Block]

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 Entitys Own Equity, the Series A Preferred Stock did not meet any of the criteria that would preclude equity classification. The Company concluded that the Series A Preferred Stock was more akin to an equity-type instrument than a debt-type instrument, therefore the conversion features associated with the convertible preferred stock were deemed to be clearly and closely related to the host instrument and were not bifurcated as a derivative under ASC 815.

 

Income Tax, Policy [Policy Text Block]

Income Taxes

 

Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the 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.

 

Earnings Per Share, Policy [Policy Text Block]

Loss Per Share

 

The Company applies the two-class method when computing net income or loss per share attributable to common stockholders. 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.

 

  

Six months ended June 30,

 
  

2024

  

2023

 

Stock options

  161,437   254,885 

Restricted stock awards

  66,666   100,000 

Common stock warrants

  4,069,240   3,002,159 

  

New Accounting Pronouncements, Policy [Policy Text Block]

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 six months ended June 30, 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.

 

v3.24.2.u1
Note 3 - Summary of Significant Accounting Policies (Tables)
6 Months Ended
Jun. 30, 2024
Notes Tables  
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]
  

Six months ended June 30,

 
  

2024

  

2023

 

Stock options

  161,437   254,885 

Restricted stock awards

  66,666   100,000 

Common stock warrants

  4,069,240   3,002,159 
v3.24.2.u1
Note 4 - Prepaid Expense and Other Current Assets (Tables)
6 Months Ended
Jun. 30, 2024
Notes Tables  
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block]
   

June 30, 2024

   

December 31, 2023

 
   

(Unaudited)

         

Prepaid expense and other current assets:

               

Prepaid insurance

  $ 1,500     $ 1,078  

Prepaid clinical development costs

    830       871  

Other prepaid expense

    646       334  

Other current receivables

    6       6  

Total prepaid expense and other current assets

  $ 2,982     $ 2,289  
v3.24.2.u1
Note 5 - Accrued and Other Current Liabilities (Tables)
6 Months Ended
Jun. 30, 2024
Notes Tables  
Schedule of Accounts Payable and Accrued Liabilities [Table Text Block]
   

June 30, 2024

   

December 31, 2023

 
   

(Unaudited)

         

Accrued and other current liabilities:

               

Refund liability (see Note 6)

  $ 3,826     $  

Professional services

    3,593       2,686  

Accrued employee costs

    1,062       835  

Accrued research and development expense

    900       1,112  

Other accrued expense

    213       81  

Total accrued and other current liabilities

  $ 9,594     $ 4,714  
v3.24.2.u1
Note 8 - Commitments and Contingencies (Tables)
6 Months Ended
Jun. 30, 2024
Notes Tables  
Schedule of Milestone Payments [Table Text Block]

End of Phase I Clinical Trials of Licensed Product (completed)

 $100,000 

End of Phase II Clinical Trials of Licensed Product (completed)

 $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 
v3.24.2.u1
Note 9 - Equity (Tables)
6 Months Ended
Jun. 30, 2024
Notes Tables  
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]
      

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 

Issued

  34,903             

Outstanding as of June 30, 2024

  4,069,240   3.44  $19.47  $ 
v3.24.2.u1
Note 10 - Stock-based Compensation (Tables)
6 Months Ended
Jun. 30, 2024
Notes Tables  
Share-Based Payment Arrangement, Option, Activity [Table Text Block]
  

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 

Expired/Forfeited

  (14,000)            

Outstanding as of June 30, 2024

  161,437  $21.18   7.5  $ 

Options vested and exercisable as of June 30, 2024

  126,882  $25.18   7.0  $ 
Nonvested Restricted Stock Shares Activity [Table Text Block]
  

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 

Vested

      

Balance as of June 30, 2024 (unvested)

  66,666  $5.66 
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]
  

Three months ended June 30,

  

Six months ended June 30,

 
  

2024

  

2023

  

2024

  

2023

 
  

(Unaudited)

 

Stock-based compensation expense

                

General and administrative

 $72  $443  $283  $1,034 

Research and development

  25   101   56   205 

Total stock-based compensation expense

 $97  $544  $339  $1,239 
v3.24.2.u1
Note 11 - Fair Value Measurements (Tables)
6 Months Ended
Jun. 30, 2024
Notes Tables  
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]

Description

 

Level

   

June 30, 2024

   

December 31, 2023

 

Assets:

         

(Unaudited)

         

Money Market Account

    1     $ 475     $ 3,874  
                         

Liabilities:

                       

Warrant liabilities (Note 9)

    3     $ 8     $ 17  

Convertible note payable (Note 7)

    3     $ 7,651     $ 9,161  
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block]
   

June 30,

 
   

2024

   

2023

 

Stock price on valuation date

  $ 2.44     $ 4.84  

Time to expiration

    0.17       0.84  

Note market interest rate

    20.6 %     8.9 %

Equity volatility

    145.0 %     100.0 %

Volume volatility

    560.0 %     455.0 %

Risk-free rate

    5.48 %     5.42 %

Probability of default

    50.0 %     6.5 %
   

June 30,

 
   

2024

   

2023

 

Stock price on valuation date

  $ 2.44     $ 6.60  

Exercise price per share

  $ 115.00     $ 115.00  

Expected life

    1.90       3.15  

Volatility

    176.9 %     175.1 %

Risk-free rate

    4.8 %     5.3 %

Dividend yield

    0.0 %     0.0 %

Fair value of warrants

  $ 0.60     $ 7.93  
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block]

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  

Conversions and repayments of principal and interest (shares and cash)

     

Fair value adjustment through earnings

    23  

Default penalty

    849  

Fair value adjustment through accumulated other comprehensive loss

     

Fair value of the Note as of June 30, 2024

  $ 7,651  
         

Convertible note payable - current portion

  $ 7,651  

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  

Conversions and repayments of principal and interest (shares and cash)

    (288 )

Fair value adjustment through earnings

    665  

Fair value adjustment through accumulated other comprehensive loss

    128  

Fair value of the Note as of June 30, 2023

  $ 12,694  
         

Convertible note payable - current portion

  $ 12,694  

Convertible note payable, net of current portion

  $  

Balance as of December 31, 2023

  $ 17  

Loss upon re-measurement

    9  

Balance as of March 31, 2024

    26  

Gain upon re-measurement

    (18 )

Balance as of June 30, 2024

  $ 8  

Balance as of December 31, 2022

  $ 37  

Gain upon re-measurement

    (12 )

Balance as of March 31, 2023

    25  

Loss upon re-measurement

    11  

Balance as of June 30, 2023

  $ 36  
v3.24.2.u1
Note 2 - Going Concern (Details Textual) - USD ($)
$ in Thousands
6 Months Ended
Aug. 12, 2024
Jun. 30, 2024
Dec. 31, 2023
Revenue from Contract with Customer, Excluding Assessed Tax   $ 0  
Cash and Cash Equivalents, at Carrying Value   $ 1,898 $ 4,595
Streetervile Complaint [Member] | Subsequent Event [Member] | Convertible Debt [Member]      
Litigation Settlement, Amount Awarded to Other Party $ 5,600    
v3.24.2.u1
Note 3 - Summary of Significant Accounting Policies (Details Textual)
$ / shares in Units, $ in Millions
1 Months Ended
Apr. 01, 2024
$ / shares
shares
Apr. 30, 2024
shares
Jun. 30, 2024
USD ($)
$ / shares
Dec. 31, 2023
$ / shares
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares $ 0.001   $ 0.001 $ 0.001
Stock Issued During Period, Shares, Reverse Stock Splits (in shares) | shares 0 73,040    
Money Market Funds [Member]        
Cash, Uninsured Amount | $     $ 1.3  
Stockholders' Equity, Reverse Stock Split [Member]        
Stockholders' Equity Note, Stock Split, Conversion Ratio 10      
v3.24.2.u1
Note 3 - Summary of Significant Accounting Policies - Schedule of Antidilutive Securities (Details) - shares
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Share-Based Payment Arrangement, Option [Member]    
Antidilutive securities (in shares) 161,437 254,885
Restricted Stock [Member]    
Antidilutive securities (in shares) 66,666 100,000
Warrant [Member]    
Antidilutive securities (in shares) 4,069,240 3,002,159
v3.24.2.u1
Note 4 - Prepaid Expense and Other Current Assets - Schedule of Prepaid Expense and Other Current Assets (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Prepaid insurance $ 1,500 $ 1,078
Prepaid clinical development costs 830 871
Other prepaid expense 646 334
Other current receivables 6 6
Total prepaid expense and other current assets $ 2,982 $ 2,289
v3.24.2.u1
Note 5 - Accrued and Other Current Liabilities - Schedule of Accrued and Other Current Liabilities (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Refund liability (see Note 6) $ 3,826 $ 0
Professional services 3,593 2,686
Accrued employee costs 1,062 835
Accrued research and development expense 900 1,112
Other accrued expense 213 81
Total accrued and other current liabilities $ 9,594 $ 4,714
v3.24.2.u1
Note 6 - Alvogen Licensing Agreement (Details Textual) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended
Jun. 30, 2024
Feb. 29, 2024
Feb. 07, 2024
Dec. 31, 2023
Jun. 02, 2023
Customer Refund Liability, Current $ 3,826     $ 0  
Alvogen and Lotus Warrants [Member]          
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)     419,598    
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)     $ 4    
Warrants and Rights Outstanding, Term (Year)     3 years    
Warrants and Rights Outstanding     $ 1,300    
Alvogen Licensing Agreement [Member]          
License Agreement, Initial Payment   $ 4,000     $ 9,000
License Agreement, Accelerating Payment   $ 5,000      
Customer Refund Liability, Current 3,800        
Stock Subscriptions Receivable, Write Off $ 1,300        
Alvogen Licensing Agreement [Member] | Alvogen and Lotus Warrants [Member]          
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)   419,598      
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)   $ 4      
Warrants and Rights Outstanding, Term (Year)   3 years      
Warrants and Rights Outstanding   $ 1,300      
v3.24.2.u1
Note 7 - Debt (Details Textual) - USD ($)
3 Months Ended 6 Months Ended
Jul. 29, 2024
Apr. 24, 2024
Feb. 09, 2024
Jul. 10, 2023
Jul. 07, 2023
Nov. 04, 2022
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Loss on Contract Termination for Default             $ 849,000 $ 0 $ 849,000 $ 0  
Streetervile Complaint [Member]                      
Loss Contingency, Damages Sought, Value   $ 6,537,027                  
Streetervile Complaint [Member] | Subsequent Event [Member]                      
Stockholders Equity Note Spinoff Transaction, Percentage 49.00%                    
Convertible Debt [Member]                      
Debt Instrument, Interest Rate, Stated Percentage           9.00%          
Debt Instrument, Face Amount           $ 11,000,000          
Debt Instrument, Term (Month)           18 months          
Debt Instrument, Unamortized Discount           $ 1,000,000          
Proceeds from Issuance of Debt           $ 10,000,000          
Debt Instrument, Prepayment Percentage           110.00%          
Debt Instrument, Redemption Amount           $ 1,000,000          
Debt Instrument, Redemption Price, Percentage           10.00%          
Debt Instrument, Redemption Conversion Price, Percentage           85.00%          
Debt Instrument, Conditional Default Interest Rate           18.00%          
Debt Instrument, Convertible, Maximum Percentage of Equity Issuable           9.99%          
Repayments of Debt                 100,000    
Debt Instrument, Periodic Payment     $ 400,000                
Liabilities, Fair Value Adjustment             100,000 $ 300,000 700,000 $ 2,400,000  
Interest Expense, Debt             100,000        
Redemption Premium                 200,000    
Debt Conversion, Converted Instrument, Amount             100,000   200,000    
Loss on Contract Termination for Default             800,000        
Long-Term Debt, Gross             $ 6,500,000   $ 6,500,000   $ 8,300,000
Convertible Debt [Member] | Convertible Note Amendment 2 [Member]                      
Repayments of Debt       $ 1,800,000              
Debt Instrument, Periodic Payment         $ 400,000            
Convertible Debt [Member] | Convertible Note Amendment 2 [Member] | Maximum [Member]                      
Debt Instrument, Periodic Payment         $ 1,000,000            
Convertible Debt [Member] | Convertible Note Amendment 3 [Member]                      
Repayments of Debt     1,100,000                
Debt Instrument, Periodic Payment     $ 400,000                
v3.24.2.u1
Note 8 - Commitments and Contingencies (Details Textual) - USD ($)
3 Months Ended 6 Months Ended
Aug. 12, 2024
Jul. 29, 2024
Apr. 24, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Apr. 16, 2022
Apr. 16, 2021
Streetervile Complaint [Member]                
Loss Contingency, Damages Sought, Value     $ 6,537,027          
Streetervile Complaint [Member] | Subsequent Event [Member]                
Stockholders Equity Note Spinoff Transaction, Percentage   49.00%            
Streetervile Complaint [Member] | Subsequent Event [Member] | Convertible Debt [Member]                
Litigation Settlement, Amount Awarded to Other Party $ 5,600,000              
Sarah Herzog Memorial Hospital License Agreement [Member]                
License Agreements, Milestone Payments, Conditional Reduction Percentage         25.00%      
License Agreement, Milestone Payment         $ 0 $ 0    
Payments for Royalties       $ 0   $ 0    
License Agreement, Maintenance Fee             $ 150,000 $ 100,000
Sarah Herzog Memorial Hospital License Agreement [Member] | Maximum [Member]                
Royalty Percentage         8.50%      
Sarah Herzog Memorial Hospital License Agreement [Member] | Products Covered By Licensed Patents [Member]                
Royalty Percentage         1.00%      
Sarah Herzog Memorial Hospital License Agreement [Member] | Products Covered by Valid Claims [Member]                
Royalty Percentage         2.50%      
v3.24.2.u1
Note 8 - Commitments and Contingencies - Schedule of Milestone Payments (Details) - Sarah Herzog Memorial Hospital License Agreement [Member] - USD ($)
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
End of Phase I Clinical Trials of Licensed Product (completed) $ 0 $ 0
End of Phase I Clinical Trials of Licensed Product [Member]    
End of Phase I Clinical Trials of Licensed Product (completed) 100,000  
End of Phase II Clinical Trials of Licensed Product [Member]    
End of Phase I Clinical Trials of Licensed Product (completed) 250,000  
End of Phase III Clinical Trials of Licensed Product [Member]    
End of Phase I Clinical Trials of Licensed Product (completed) 250,000  
First Commercial Sale of Licensed Product in U.S. [Member]    
End of Phase I Clinical Trials of Licensed Product (completed) 500,000  
First Commercial Sale of Licensed Product in Europe [Member]    
End of Phase I Clinical Trials of Licensed Product (completed) 500,000  
Annual Revenue Threshold [Member]    
End of Phase I Clinical Trials of Licensed Product (completed) $ 750,000  
v3.24.2.u1
Note 9 - Equity (Details Textual)
$ / shares in Units, $ in Thousands
1 Months Ended 2 Months Ended 3 Months Ended 6 Months Ended
May 23, 2024
USD ($)
$ / shares
shares
Apr. 18, 2024
USD ($)
$ / shares
shares
Apr. 01, 2024
$ / shares
shares
Mar. 06, 2024
USD ($)
Feb. 29, 2024
USD ($)
$ / shares
shares
Feb. 28, 2024
USD ($)
$ / shares
shares
Feb. 27, 2024
USD ($)
$ / shares
shares
Jan. 02, 2024
USD ($)
shares
Aug. 14, 2023
USD ($)
Apr. 30, 2024
shares
Mar. 31, 2024
shares
Aug. 31, 2023
USD ($)
shares
Apr. 15, 2024
USD ($)
shares
Jun. 30, 2024
USD ($)
$ / shares
shares
Mar. 31, 2024
USD ($)
shares
Jun. 30, 2023
USD ($)
Jun. 30, 2024
USD ($)
$ / shares
shares
Jun. 30, 2023
USD ($)
Apr. 19, 2024
USD ($)
shares
Mar. 28, 2024
shares
Mar. 11, 2024
$ / shares
Mar. 05, 2024
USD ($)
shares
Feb. 07, 2024
USD ($)
$ / shares
shares
Dec. 31, 2023
$ / shares
shares
May 24, 2021
$ / shares
shares
Common Stock, Shares, Issued (in shares)     9,600,000                     10,791,630     10,791,630     95,700,000       8,391,940  
Stock Issued During Period, Shares, Reverse Stock Splits (in shares)     0             73,040                              
Preferred Stock, Shares Authorized (in shares)                           50,000,000     50,000,000                
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares                           $ 0.001     $ 0.001                
Common Stock, Shares Authorized (in shares)                           500,000,000     500,000,000             500,000,000  
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares     $ 0.001                     $ 0.001     $ 0.001             $ 0.001  
Stock Issued During Period, Value, Conversion of Convertible Securities | $                             $ 0                    
Proceeds from Issuance of Private Placement | $                                 $ 1,027 $ 8,122              
Class of Warrant or Right, Outstanding (in shares)                     4,034,337     4,069,240 4,034,337   4,069,240             3,321,499  
Fair Value Adjustment of Warrants | $                           $ (18)   $ 11 $ (9) (1)              
Common Stock, Shares, Outstanding (in shares)     9,600,000                     10,791,630     10,791,630     95,700,000       8,391,940  
February Warrants [Member]                                                  
Warrants and Rights Outstanding, Term (Year)           5 years                                      
Warrants and Rights Outstanding | $           $ 500                                      
February Warrants [Member] | Measurement Input, Share Price [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           3.59                                      
February Warrants [Member] | Measurement Input, Exercise Price [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           3.8                                      
February Warrants [Member] | Measurement Input, Expected Term [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           5                                      
February Warrants [Member] | Measurement Input, Price Volatility [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           1.781                                      
February Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           0.0426                                      
February Warrants [Member] | Measurement Input, Expected Dividend Rate [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           0                                      
Substitute Warrants [Member]                                                  
Fair Value Adjustment of Warrants | $                           $ 100   100 $ 100 100              
Substitute Warrants [Member] | Neuro Rx [Member]                                                  
Foreign Currency Exchange Rate, Remeasurement                                                 0.316
Class of Warrant or Right, Outstanding (in shares)                                                 3,792,970
Public Warrants [Member]                                                  
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)                                               344,886 345,000
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares                                                 $ 115
Class of Warrant or Right, Outstanding (in shares)                           3,448,856     3,448,856               3,450,000
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares)                                                 0.1
Private Placement Warrants [Member]                                                  
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)                           13,625     13,625                
Class of Warrant or Right, Outstanding (in shares)                           136,250     136,250                
Fair Value Adjustment of Warrants | $                           $ 100   $ 100 $ 100 $ 100              
February Underwriter Warrants [Member]                                                  
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)           25,000                                      
Warrants and Rights Outstanding, Term (Year)           5 years                                      
Warrants and Rights Outstanding | $           $ 100                                      
February Underwriter Warrants [Member] | Measurement Input, Share Price [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           3.05                                      
February Underwriter Warrants [Member] | Measurement Input, Exercise Price [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           3.3                                      
February Underwriter Warrants [Member] | Measurement Input, Expected Term [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           5                                      
February Underwriter Warrants [Member] | Measurement Input, Price Volatility [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           1.781                                      
February Underwriter Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           0.0426                                      
February Underwriter Warrants [Member] | Measurement Input, Expected Dividend Rate [Member]                                                  
Warrants and Rights Outstanding, Measurement Input           0                                      
Underwriter Overallotment Warrants [Member]                                                  
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)                                           3,750      
Warrants and Rights Outstanding | $                                     $ 100     $ 100      
Underwriter Overallotment Warrants [Member] | Measurement Input, Share Price [Member]                                                  
Warrants and Rights Outstanding, Measurement Input 3.62                                   3.04     3.05      
Underwriter Overallotment Warrants [Member] | Measurement Input, Exercise Price [Member]                                                  
Warrants and Rights Outstanding, Measurement Input 3.63                                   3.63     3.3      
Underwriter Overallotment Warrants [Member] | Measurement Input, Expected Term [Member]                                                  
Warrants and Rights Outstanding, Measurement Input 5                                   5     5      
Underwriter Overallotment Warrants [Member] | Measurement Input, Price Volatility [Member]                                                  
Warrants and Rights Outstanding, Measurement Input 1.781                                   1.781     1.781      
Underwriter Overallotment Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]                                                  
Warrants and Rights Outstanding, Measurement Input 0.0452                                   0.0466     0.0412      
Underwriter Overallotment Warrants [Member] | Measurement Input, Expected Dividend Rate [Member]                                                  
Warrants and Rights Outstanding, Measurement Input 0                                   0     0      
Alvogen and Lotus Warrants [Member]                                                  
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)                                             419,598    
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares                                             $ 4    
Warrants and Rights Outstanding, Term (Year)                                             3 years    
Warrants and Rights Outstanding | $                                             $ 1,300    
Class of Warrant or Right, Beneficial Ownership Limitation                                             4.99%    
Alvogen and Lotus Warrants [Member] | Measurement Input, Share Price [Member]                                                  
Warrants and Rights Outstanding, Measurement Input                                             4.1    
Alvogen and Lotus Warrants [Member] | Measurement Input, Exercise Price [Member]                                                  
Warrants and Rights Outstanding, Measurement Input                                             4    
Alvogen and Lotus Warrants [Member] | Measurement Input, Expected Term [Member]                                                  
Warrants and Rights Outstanding, Measurement Input                                             3    
Alvogen and Lotus Warrants [Member] | Measurement Input, Price Volatility [Member]                                                  
Warrants and Rights Outstanding, Measurement Input                                             1.38    
Alvogen and Lotus Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]                                                  
Warrants and Rights Outstanding, Measurement Input                                             0.042    
Alvogen and Lotus Warrants [Member] | Measurement Input, Expected Dividend Rate [Member]                                                  
Warrants and Rights Outstanding, Measurement Input                                             0    
Maximum [Member] | Alvogen and Lotus Warrants [Member]                                                  
Class of Warrant or Right, Beneficial Ownership Limitation                                             9.99%    
ATM Offering [Member]                                                  
Stock Issued During Period, Shares, New Issues (in shares)                         282,452                        
Stock Issued During Period, Value, New Issues | $                 $ 4,900       $ 1,400 $ 1,228 $ 179                    
ATM Offering [Member] | Minimum [Member]                                                  
Shares Issued, Price Per Share (in dollars per share) | $ / shares                                         $ 4.643        
ATM Offering [Member] | Maximum [Member]                                                  
Shares Issued, Price Per Share (in dollars per share) | $ / shares                                         $ 7.1        
Private Placement [Member]                                                  
Stock Issued During Period, Shares, New Issues (in shares)         270,000 270,000                                      
Stock Issued During Period, Value, New Issues | $                             $ 1,027                    
Private Placement, Premium Percentage         26.70%                                        
Proceeds from Issuance of Private Placement | $         $ 1,000                                        
Private Placement [Member] | February Warrants [Member]                                                  
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)         270,000 270,000                                      
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares         $ 3.8 $ 3.8                                      
February Underwriting Agreement [Member]                                                  
Stock Issued During Period, Shares, New Issues (in shares)             500,000                                    
Shares Issued, Price Per Share (in dollars per share) | $ / shares             $ 2.76                                    
Share Price (in dollars per share) | $ / shares             $ 3                                    
Proceeds from Issuance or Sale of Equity | $       $ 200     $ 1,300                                    
Payments of Stock Issuance Costs | $       $ 200     $ 400                                    
February Overallotment Option [Member]                                                  
Stock Issued During Period, Shares, New Issues (in shares)             75,000                                    
April Underwriter Agreement [Member]                                                  
Stock Issued During Period, Shares, New Issues (in shares)   607,000                                              
Shares Issued, Price Per Share (in dollars per share) | $ / shares   $ 3.3                                              
April Overallotment Agreement [Member]                                                  
Stock Issued During Period, Shares, New Issues (in shares) 91,050 91,050                                              
Shares Issued, Price Per Share (in dollars per share) | $ / shares $ 3.3                                                
Proceeds from Issuance or Sale of Equity | $ $ 200                                                
Payments of Stock Issuance Costs | $ $ 100                                                
April 2024 Offering [Member]                                                  
Payments of Stock Issuance Costs | $   $ 400                                              
Proceeds from Issuance of Common Stock | $   $ 1,600                                              
April 2024 Offering [Member] | April Underwriter Warrants [Member]                                                  
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) 4,553                                   30,350            
Warrants and Rights Outstanding, Term (Year)                                     6 years            
April 2024 Offering [Member] | April Overallotment Warrants [Member]                                                  
Warrants and Rights Outstanding, Term (Year)                                     5 years            
Streeterville Capital, LLC [Member]                                                  
Stock Issued During Period, Shares, Conversion of Convertible Securities (in shares)               143,648                                  
Stock Issued During Period, Value, Conversion of Convertible Securities | $               $ 400                                  
Preferred Stock [Member]                                                  
Stock Issued During Period, Shares, Reverse Stock Splits (in shares)                           0                      
Stock Issued During Period, Shares, Conversion of Convertible Securities (in shares)                             0                    
Stock Issued During Period, Value, Conversion of Convertible Securities | $                             $ 0                    
Preferred Stock [Member] | ATM Offering [Member]                                                  
Stock Issued During Period, Shares, New Issues (in shares)                           0 0                    
Stock Issued During Period, Value, New Issues | $                           $ 0 $ 0                    
Preferred Stock [Member] | Private Placement [Member]                                                  
Stock Issued During Period, Shares, New Issues (in shares)                             0                    
Stock Issued During Period, Value, New Issues | $                             $ 0                    
Conversion of Series A Preferred Stock to Preferred Stock [Member] | Preferred Stock [Member]                                                  
Conversion of Stock, Shares Issued (in shares)                     300,000                            
Series A Preferred Stock [Member]                                                  
Preferred Stock, Shares Authorized (in shares)                           12,000,000     12,000,000                
Stock Issued During Period, Shares, New Issues (in shares)                       3,000,000                          
Stock Issued During Period, Value, New Issues | $                       $ 1,200                          
Preferred Stock, Shares Issued (in shares)                           0     0                
Preferred Stock, Shares Outstanding (in shares)                           0     0                
Series A Preferred Stock [Member] | Preferred Stock [Member]                                                  
Stock Issued During Period, Shares, Reverse Stock Splits (in shares)                           0                      
Conversion of Stock, Shares Converted (in shares)                             3,000,000                    
Series A Preferred Stock [Member] | Preferred Stock [Member] | ATM Offering [Member]                                                  
Stock Issued During Period, Shares, New Issues (in shares)                           0 0                    
Stock Issued During Period, Value, New Issues | $                           $ 0 $ 0                    
Series A Preferred Stock [Member] | Preferred Stock [Member] | Private Placement [Member]                                                  
Stock Issued During Period, Shares, New Issues (in shares)                             0                    
Stock Issued During Period, Value, New Issues | $                             $ 0                    
Series A Preferred Stock [Member] | Conversion of Series A Preferred Stock to Preferred Stock [Member]                                                  
Conversion of Stock, Shares Converted (in shares)                     3,000,000                            
Reverse Stock Split [Member]                                                  
Stockholders' Equity Note, Stock Split, Conversion Ratio     10                                            
v3.24.2.u1
Note 9 - Equity - Schedule of Warrants (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 12 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Dec. 31, 2023
Outstanding as of December 31, 2023 (in shares) 4,034,337 3,321,499  
Outstanding as of December 31, 2023 (Year) 3 years 5 months 8 days 3 years 8 months 4 days 3 years 10 months 28 days
Outstanding as of December 31, 2023 (in dollars per share) $ 19.47 $ 19.61 $ 23.01
Outstanding as of December 31, 2023 $ 0 $ 807 $ 180
Issued (in shares) 34,903 718,348  
Expired (in shares)   (5,510)  
Outstanding as of March 31, 2024 (in shares) 4,069,240 4,034,337 3,321,499
v3.24.2.u1
Note 10 - Stock-based Compensation (Details Textual)
$ / shares in Units, $ in Thousands
3 Months Ended 6 Months Ended 30 Months Ended
Jan. 01, 2024
shares
Dec. 28, 2023
USD ($)
$ / shares
shares
Jul. 12, 2022
shares
Jun. 30, 2024
USD ($)
$ / shares
shares
Jun. 30, 2023
USD ($)
Jun. 30, 2024
USD ($)
$ / shares
shares
Jun. 30, 2023
USD ($)
Jun. 30, 2024
USD ($)
$ / shares
shares
Mar. 31, 2024
$ / shares
shares
Dec. 31, 2023
$ / shares
shares
Jan. 01, 2022
May 24, 2021
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number (in shares)       161,437   161,437   161,437 175,437 264,983    
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price (in dollars per share) | $ / shares       $ 21.18   $ 21.18   $ 21.18 $ 18.6 $ 18.3    
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)       0   0            
Share-Based Payment Arrangement, Expense | $       $ 97 $ 544 $ 339 $ 1,239          
Share-Based Payment Arrangement, Option [Member]                        
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Dividend Rate           0.00%            
Share-Based Payment Arrangement, Expense | $       100   $ 300            
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $       100   $ 100   $ 100        
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)           1 year 2 months 12 days            
Restricted Stock [Member]                        
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)   57,500                    
Share-Based Payment Arrangement, Expense | $       100 $ 100              
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $       $ 200   $ 200   $ 200        
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)           1 year            
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year)   6 months                    
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares   $ 4.6                    
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Grant Date Fair Value | $   $ 300                    
Restricted Stock [Member] | Chief Executive Officer [Member]                        
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares)     100,000                  
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year)     3 years                  
The 2016 Omnibus Incentive Plan [Member]                        
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)       347,200   347,200   347,200        
The 2016 Omnibus Incentive Plan [Member] | Neuro Rx [Member]                        
Foreign Currency Exchange Rate, Remeasurement                       0.316
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number (in shares)                       289,542
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price (in dollars per share) | $ / shares                       $ 51
The 2021 Omnibus Incentive Plan [Member]                        
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)       955,281   955,281   955,281        
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares) 83,920 200,000                    
Share-Based Compensation Arrangement by Share-Based Payment Award, Annual Percentage Increase in Authorized Shares                     1.00%  
Shares Issued, Shares, Share-Based Payment Arrangement, after Forfeiture (in shares)               608,365        
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares)       346,916   346,916   346,916        
v3.24.2.u1
Note 10 - Stock-based Compensation - Schedule of Stock Options (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2024
Dec. 31, 2023
Outstanding, balance (in shares) 175,437 264,983 264,983  
Outstanding, weighted average exercise price (in dollars per share) $ 18.6 $ 18.3 $ 18.3  
Outstanding, weighted average remaining contractual term (Year) 7 years 6 months 8 years 4 months 24 days   7 years 8 months 12 days
Outstanding, aggregate intrinsic value $ 0 $ 40 $ 0 $ 75
Expired/Forfeited (in shares)   (89,546) (14,000)  
Outstanding, balance (in shares) 161,437 175,437 161,437 264,983
Outstanding, weighted average exercise price (in dollars per share) $ 21.18 $ 18.6 $ 21.18 $ 18.3
Options vested and exercisable (in shares) 126,882   126,882  
Options vested and exercisable, weighted average exercise price (in dollars per share) $ 25.18   $ 25.18  
Options vested and exercisable, weighted average remaining contractual term (Year)     7 years  
Options vested and exercisable, aggregate intrinsic value $ 0   $ 0  
v3.24.2.u1
Note 10 - Stock-based Compensation - Schedule of Restricted Stock Awards (Details) - Restricted Stock [Member] - $ / shares
3 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Dec. 31, 2023
Balance (unvested) (in shares) 66,666 124,166  
Unvested, weighted average grant date fair value (in dollars per share) $ 5.66 $ 5.66 $ 5.2
Vested (in shares) 0 (57,500)  
Vested, weighted average grant date fair value (in dollars per share) $ 0 $ 4.64  
Vested (in shares) 0 57,500  
Balance (unvested) (in shares) 66,666 66,666  
v3.24.2.u1
Note 10 - Stock-based Compensation - Schedule of Stock-based compensation (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Stock-based compensation expense $ 97 $ 544 $ 339 $ 1,239
General and Administrative Expense [Member]        
Stock-based compensation expense 72 443 283 1,034
Research and Development Expense [Member]        
Stock-based compensation expense $ 25 $ 101 $ 56 $ 205
v3.24.2.u1
Note 11 - Fair Value Measurements - Schedule of Assets and Liabilities on A Recurring Basis (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Warrant liabilities (Note 9) $ 8 $ 17
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member]    
Money Market Account 475 3,874
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member]    
Warrant liabilities (Note 9) 8 17
Convertible note payable (Note 7) $ 7,651 $ 9,161
v3.24.2.u1
Note 11 - Fair Value Measurements - Schedule of Significant Inputs (Details)
Jun. 30, 2024
$ / shares
Dec. 31, 2023
Jun. 30, 2023
$ / shares
Warrants [Member]      
Fair value of warrants (in dollars per share) $ 0.6   $ 7.93
Measurement Input, Share Price [Member] | Convertible Debt [Member]      
Measurement input 2.44 4.84  
Measurement Input, Share Price [Member] | Warrants [Member]      
Warrant measurement input 2.44   6.6
Measurement Input, Expected Term [Member] | Convertible Debt [Member]      
Measurement input 0.17 0.84  
Measurement Input, Expected Term [Member] | Warrants [Member]      
Warrant measurement input 1.9   3.15
Measurement Input, Exercise Price [Member] | Warrants [Member]      
Warrant measurement input 115   115
Measurement Input, Market Rate [Member[ | Convertible Debt [Member]      
Measurement input 0.206 0.089  
Measurement Input, Price Volatility [Member] | Convertible Debt [Member]      
Measurement input 1.45 1  
Measurement Input, Price Volatility [Member] | Warrants [Member]      
Warrant measurement input 1.769   1.751
Measurement Input, Volume Volatility [Member] | Convertible Debt [Member]      
Measurement input 5.60 4.55  
Measurement Input, Risk Free Interest Rate [Member] | Convertible Debt [Member]      
Measurement input 0.0548 0.0542  
Measurement Input, Risk Free Interest Rate [Member] | Warrants [Member]      
Warrant measurement input 0.048   0.053
Measurement Input, Expected Dividend Rate [Member] | Warrants [Member]      
Warrant measurement input 0   0
Measurement Input, Probability of Default [Member] | Convertible Debt [Member]      
Measurement input 0.50 0.065  
v3.24.2.u1
Note 11 - Fair Value Measurements - Schedule of Level 3 Fair Value Changes (Details) - USD ($)
$ in Thousands
3 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Convertible note payable - current portion $ 7,651   $ 12,694  
Convertible note payable, net of current portion 0   0  
Convertible Debt [Member]        
Fair value of the Note as of December 31, 2023 6,779 $ 9,161 12,189 $ 10,525
Conversions and repayments of principal and interest (shares and cash) 0 (2,700) (288) 0
Fair value adjustment through earnings 23 318 665 1,770
Fair value adjustment through accumulated other comprehensive loss 0 0 128 (106)
Default penalty 849      
Fair value of the Note as of March 31, 2024 7,651 6,779 12,694 12,189
Warrants [Member]        
Fair value of the Note as of December 31, 2023 26 17 25 37
Fair value adjustment through earnings (18) 9 11 (12)
Fair value of the Note as of March 31, 2024 $ 8 $ 26 $ 36 $ 25
v3.24.2.u1
Note 12 - Income Taxes (Details Textual) - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Income Tax Expense (Benefit) $ 0 $ 0
v3.24.2.u1
Note 13 - Related Party Transactions (Details Textual) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Mar. 29, 2023
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Nov. 06, 2022
Accounts Payable, Current   $ 5,015   $ 5,015   $ 4,632  
Glytech License Agreement [Member]              
Related Party Transaction, Amounts of Transaction   100 $ 100 100 $ 100    
Glytech License Agreement [Member] | NRX Pharmaceuticals, Inc [Member] | Minimum [Member]              
Investment Owned, Fair Value             $ 50,000
Consultation Agreement with Dr. Jonathan Javitt [Member]              
Related Party Transaction, Amounts of Transaction   200 100 400 $ 500    
Consultation Agreement with Zachary Javitt [Member]              
Related Party Transaction, Amounts of Transaction   100 $ 100        
Consulting Agreement, Annual Payment $ 600            
Consulting Agreement, Monthly Payment 100            
Consulting Agreement, Performance Bonus, Target Value $ 300            
Accrued Bonuses, Current   300   300   200  
Accounts Payable, Current   $ 100   $ 100   $ 100  
Consultation Agreement with Zachary Javitt [Member] | Restricted Stock [Member]              
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Granted (in shares) 50,000            
Consultation Agreement with Zachary Javitt [Member] | Restricted Stock [Member] | Unrestricted Upon New Drug Application Date [Member]              
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Granted (in shares) 25,000            
Consultation Agreement with Zachary Javitt [Member] | Restricted Stock [Member] | Unrestricted Upon New Drug Approval Date [member]              
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Granted (in shares) 25,000            
v3.24.2.u1
Note 14 - Subsequent Event (Details Textual) - USD ($)
$ / shares in Units, $ in Millions
1 Months Ended
Aug. 12, 2024
Aug. 01, 2024
Nov. 04, 2022
Jul. 30, 2024
Convertible Debt [Member]        
Debt Instrument, Interest Rate, Stated Percentage     9.00%  
Debt Instrument, Term (Month)     18 months  
Subsequent Event [Member] | Streetervile Complaint [Member] | Convertible Debt [Member]        
Litigation Settlement, Amount Awarded to Other Party $ 5.6      
Litigation Settlement, Payment Installment One 2.5      
Litigation Settlement, Payment Installment Two $ 3.1      
Subsequent Event [Member] | Senior Secured Convertible Debt [Member]        
Debt Instrument, Interest Rate, Stated Percentage   6.00%    
Debt Instrument, Term (Month)   15 months    
Debt Instrument, Convertible, Conversion Price (in dollars per share)   $ 2.4168    
Debt Instrument, Convertible, Threshold Percentage of Stock Price Trigger   92.00%    
ATM Purchase Agreements [Member] | Subsequent Event [Member] | Unregistered Common Stock [Member]        
Stock Issued During Period, Shares, New Issues (in shares)       103,063
Proceeds from Issuance of Common Stock       $ 0.3
ATM Purchase Agreements [Member] | Subsequent Event [Member] | Unregistered Common Stock [Member] | Minimum [Member]        
Shares Issued, Price Per Share (in dollars per share)       $ 2.421
ATM Purchase Agreements [Member] | Subsequent Event [Member] | Unregistered Common Stock [Member] | Maximum [Member]        
Shares Issued, Price Per Share (in dollars per share)       $ 2.528
Securities Purchase Agreement [Member] | Subsequent Event [Member]        
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)   1    
Warrants and Rights Outstanding, Term (Year)   5 years    
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)   $ 2.42    
Securities Purchase Agreement [Member] | Subsequent Event [Member] | Maximum [Member]        
Proceeds from Issuance or Sale of Equity   $ 16.3    
Proceeds from Convertible Debt   16.3    
Proceeds from Issuance of Warrants   $ 1.4    

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