NRX Pharmaceuticals, Inc.
For the period ended Jun 30, 2025. Filed Aug 18, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 18, 2025
Contents
Item 1. Financial Statements
| Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024 | 3 | |
| Unaudited Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024 | 4 | |
| Unaudited Condensed Consolidated Statements of Changes in Stockholders' Deficit for the three and six months ended June 30, 2025 and 2024 | 5 | |
| Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024 | 6 | |
| Notes to Unaudited Condensed Consolidated Financial Statements | 7 | |
| ITEM 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 32 |
|---|---|---|
| ITEM 3. | Quantitative and Qualitative Disclosures About Market Risk | 43 |
| ITEM 4. | Controls and Procedures | 44 |
| PART II - OTHER INFORMATION | ||
| ITEM 1. | Legal Proceedings | 44 |
| ITEM 1A. | Risk Factors | 45 |
| ITEM 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 45 |
| ITEM 3. | Defaults Upon Senior Securities | 46 |
| ITEM 4. | Mine Safety Disclosures | 46 |
| ITEM 5. | Other Information | 46 |
| ITEM 6. | Exhibits | 46 |
| SIGNATURES | 47 | |
PART I FINANCIAL INFORMATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| (Unaudited) | ||
| ASSETS | ||
| Current assets: | ||
| Cash and cash equivalents | $2,910 | $1,443 |
| Prepaid expenses and other current assets | 1,680 | 1,859 |
| Total current assets | 4,590 | 3,302 |
| Other assets | 248 | 349 |
| Total assets | $4,838 | $3,651 |
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||
| Current liabilities: | ||
| Accounts payable | $3,630 | $4,130 |
| Accrued and other current liabilities | 9,974 | 10,149 |
| Accrued clinical site costs | 351 | 379 |
| Convertible note payable and accrued interest – short term | 9,854 | 1,246 |
| Insurance loan payable | 378 | 320 |
| Warrant liabilities | 16,266 | 5,639 |
| Total current liabilities | 40,453 | 21,863 |
| Convertible note payable and accrued interest – long term | — | 5,011 |
| Total liabilities | $40,453 | $26,874 |
| 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 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | — | — |
| Common stock, $0.001 par value, 500,000,000 shares authorized; 19,473,588 and 14,591,505 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 19 | 15 |
| Additional paid-in capital | 265,732 | 255,035 |
| Accumulated deficit | (301,366) | (278,273) |
| Total stockholders’ deficit | (35,615) | (23,223) |
| Total liabilities and stockholders' deficit | $4,838 | $3,651 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Operating expense: | ||||
| Research and development | $987 | $2,804 | $1,791 | $4,552 |
| General and administrative | 2,743 | 4,246 | 5,686 | 8,496 |
| Settlement expense | — | — | 100 | — |
| Total operating expenses | 3,730 | 7,050 | 7,577 | 13,048 |
| Loss from operations | (3,730) | (7,050) | (7,577) | (13,048) |
| Other (income) expense: | ||||
| Interest income | (2) | (7) | (6) | (34) |
| Interest expense | — | — | — | 230 |
| Change in fair value of convertible note payable | 5,565 | 23 | 6,530 | 341 |
| Change in fair value of warrant liabilities | 6,414 | (18) | 3,518 | (9) |
| Convertible note default penalty | — | 849 | — | 849 |
| Loss on issuance of the Registered Direct Offering (see Note 9) | — | — | 729 | — |
| Loss on Consideration Shares and Warrants (see Note 9) | — | — | 1,277 | — |
| Loss on convertible note conversions | 1,874 | — | 3,467 | — |
| Total other expenses, net | 13,851 | 847 | 15,515 | 1,377 |
| Net loss | $(17,581) | $(7,897) | $(23,092) | $(14,425) |
| Net loss per share: | ||||
| Basic and diluted | $(0.98) | $(0.75) | $(1.34) | $(1.49) |
| Weighted average common shares outstanding: | ||||
| Basic and diluted | 17,934,196 | 10,517,460 | 17,176,339 | 9,684,873 |
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’** DEFICIT**
(in thousands, except share data)
| Series A Preferred Stock · Common Stock · Additional Paid-in- · Accumulated · Accumulated Other Comprehensive · Total Stockholders’ | ||||||||
|---|---|---|---|---|---|---|---|---|
| Shares | Amount | Shares | Amount | Capital | Deficit | Loss | Deficit | |
| Balance - December 31, 2024 | — | $— | 14,591,505 | $15 | $255,035 | $(278,273) | $— | $(23,223) |
| Shares issued as conversion of principal and interest for convertible note | — | — | 1,009,518 | 1 | 2,939 | — | — | 2,940 |
| Shares issued in connection with the Registered Direct offering, net of $245 issuance costs | — | — | 1,215,278 | 1 | 3,254 | — | — | 3,255 |
| Fair value allocation of warrants issued with Registered Direct offering | — | — | — | — | (3,255) | — | — | (3,255) |
| Amortization of deferred offering costs | — | — | — | — | (7) | — | — | (7) |
| Consideration Shares issued as a result of repricing (See Note 9) | — | — | 303,819 | — | 629 | — | — | 629 |
| Stock-based compensation | — | — | — | — | 12 | — | — | 12 |
| Net loss | — | — | — | — | — | (5,512) | — | (5,512) |
| Balance – March 31, 2025 | — | $— | 17,120,120 | $17 | $258,607 | $(283,785) | $— | $(25,161) |
| Shares issued in exchange for services | — | — | 75,000 | — | 150 | — | — | 150 |
| Shares issued as conversion of principal and interest for convertible note | — | — | 1,879,406 | 2 | 5,981 | — | — | 5,983 |
| Amortization of deferred offering costs | — | — | — | — | (85) | — | — | (85) |
| At-the-market "ATM" offering, net of offering costs of $26 | — | — | 399,078 | — | 1,012 | — | — | 1,012 |
| Stock-based compensation | — | — | — | — | 67 | — | — | 67 |
| Net loss | — | — | — | — | — | (17,581) | — | (17,581) |
| Balance – June 30, 2025 | — | $— | 19,473,588 | $19 | $265,732 | $(301,366) | $— | $(35,615) |
| Series A Preferred Stock · Common Stock · Additional Paid-in- · Accumulated · Accumulated Other Comprehensive · Total Stockholders’ | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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) |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
| Six months ended June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||
| Net loss | $(23,092) | $(14,425) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation expense | — | 2 |
| Stock-based compensation | 79 | 339 |
| Common stock issued in exchange for services | 150 | — |
| Change in fair value of warrant liabilities | 3,518 | (9) |
| Change in fair value of convertible promissory note | 6,530 | 341 |
| Loss on Consideration Shares and Warrants | 1,277 | — |
| Loss on issuance of Registered Direct Offering | 729 | — |
| Loss on convertible notes conversion | 3,467 | — |
| Expense for debt issuance costs due to fair value election on Anson Notes | 350 | — |
| Warrant issuance costs related to Alvogen termination | — | 1,336 |
| Convertible note default penalty | — | 849 |
| Changes in operating assets and liabilities: | ||
| Prepaid expense and other assets | 187 | (648) |
| Accounts payable | (501) | 4,209 |
| Insurance loan payable | — | 943 |
| Accrued expense and other liabilities | (202) | 830 |
| Net cash used in operating activities | (7,508) | (6,233) |
| CASH FLOWS FROM FINANCING ACTIVITIES | ||
| Repayment of convertible note | — | (2,156) |
| Repayment of insurance loan | (394) | — |
| Expense for debt issuance costs due to fair value election on Anson Notes | (350) | — |
| Proceeds from issuance of insurance loan | 452 | — |
| Proceeds from Anson convertible notes, net of OID | 5,000 | — |
| Proceeds from issuance of common stock and warrants issued in Registered Direct offering, net of issuance costs | 3,255 | — |
| Proceeds from ATM offering, net of offering costs | 1,012 | — |
| 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 |
| Net cash provided by financing activities | 8,975 | 3,536 |
| Net increase (decrease) in cash and cash equivalents | 1,467 | (2,697) |
| Cash and cash equivalents at beginning of period | 1,443 | 4,595 |
| Cash and cash equivalents at end of period | $2,910 | $1,898 |
| Supplemental disclosure of cash flow information: | ||
| Cash paid for interest | $— | $374 |
| Cash paid for taxes | $— | $— |
| Non-cash investing and financing activities | ||
| Issuance of common stock as principal and interest repayment for convertible notes | $5,456 | $400 |
| Issuance of common stock warrants as offering costs | $— | $188 |
| Conversion of Series A preferred stock into common stock | $— | $3 |
| Amortization of deferred offering costs to additional paid-in-capital | $92 | $— |
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025
1. Organization
The Business
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”, “we”, “us” or “our”) is a clinical-stage bio-pharmaceutical company which develops and will distribute, through its wholly-owned operating subsidiary, NeuroRx, Inc., (“NeuroRx”), novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, and post-traumatic stress disorder (“PTSD”) and 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. The Company hastwo lead drug candidates – NRX-100, a preservative-free formulation of ketamine for intravenous infusion, and NRX-101, an oral fixed dose combination of D-cycloserine and lurasidone. NRX-100 and NRX-101 are in the process of submission for Food and Drug Administration (“FDA”) approval as follows:
| 1. | An Abbreviated New Drug Application (“ANDA”) for NRX-100 was filed, with Priority Review requested, during the second quarter of 2025 with a first response received August 13, 2025. |
| 2. | A New Drug Application (“NDA”) for NRX-100, originally initiated during the fourth quarter of 2024, is expected to be completed in September 2025. This follows the Company’s successful application for a waiver under the Prescription Drug User Fee Act ("PDUFA"), which is expected to save the Company approximately $4.3 million in filing fees and grant of Fast Track Designation for NRX-100 for “Treatment of Suicidal Ideation in Patients with Depression, including Bipolar Depression. The Company has applied to receive a Commissioner’s National Priority Voucher (CNPV), which could significantly reduce review time. |
| 3. | An NDA filing for NRX-101 has been initiated with the transmission of the Module 3 manufacturing file to publishing. The drug was previously awarded Breakthrough Therapy Designation and accordingly the Company is requesting rolling review of the NDA. Breakthrough Therapy Designation is granted by the FDA to facilitate the development, and expedite the review of drugs to treat serious conditions meet an unmet medical need, and have demonstrated preliminary evidence of efficacy as determined by the FDA. The Company anticipates decision dates from the FDA for both its NDA applications potentially as early as year-end 2025 (NRX-100) and the first quarter of 2026 (NRX-101). |
In* February 2024,*NRx incorporated HOPE Therapeutics, Inc. (“HOPE”), a medical care delivery organization focused on providing cutting-edge, comprehensive interventional psychiatric treatment of the above conditions with the most effective treatments available, including NMDA-targeted and other neuroplastic drugs, such as ketamine, Spravato and NRX-101, neuromodulatory devices, such as Transcranial Magnetic Stimulation (“TMS”), digital therapeutics, and medication management.
NeuroRx is organized as a traditional research and development (“R&D”) company, whereas HOPE is organized as a medical care delivery company intended to own and/or operate clinics that serve patients with suicidal depression, PTSD, and other serious Central Nervous System (“CNS”) disorders. Management’s plan, through the establishment of HOPE, is to transform NRx from a pre-revenue biotechnology company to a revenue-generating enterprise that continues to develop life-saving drugs and technologies through NeuroRx, while also treating patients through HOPE.
During thesecond quarter of2025 and in the subsequent period, key achievements by the Company in support of its overall mission to improve and save the lives of patients affected by central nervous system disorders including suicidal depression, chronic pain, post-traumatic stress disorder and schizophrenia include the following:
7
Drug Development
| ● | Grant of Fast Track Designation for NRX-100 from the FDA for all indications and types of depression and related disorders based on its potential to satisfy an unmet medical need. This designation represents an approximately 10-fold expansion of the addressable market to 13 million Americans, compared to the original Fast Track Designation issued in 2017 for bipolar depression alone. The Designation letter contains a specific finding that NRX-100 addresses an “unmet medical need.” This is a specific qualifying requirement for the Commissioner’s National Priority Voucher Program. |
| ● | Filing of an ANDA for NRX-100 (preservative-free intravenous ketamine). |
| ● | Filing of Commissioner’s National Priority Voucher application for intravenous ketamine (NRX-100). |
| ● | Submission of stability data for NRX-100 to the manufacturing data on file with FDA sufficient to support three years of room temperature shelf stability for NRX-100. |
| ● | Submission of draft labeling for NRX-100 in the treatment of suicidal depression based on the Fast Track Designation received. |
| ● | Completion of a toxicology assessment of Benzethonium Chloride, documenting its lack of “Generally Recognized as Safe” (GRAS) status and lack of safety data to support its use in intravenous presentations of ketamine. |
| ● | Filing of a Citizen’s Petition with the U.S. Food and Drug Administration to seek the removal of benzethonium chloride, a toxic preservative, from all ketamine products for intravenous administration. |
| ● | Filing of a patent application for NRX-100, the Company’s proprietary preservative-free formulation of intravenous ketamine. |
| ● | Receipt of filing fee waiver from the FDA for NRX-100. |
| ● | Filing of module 3 manufacturing data to support a New Drug Application for NRX-101 in the treatment of patients with suicidal bipolar depression and akathisia despite treatment with already-approved medication. |
Interventional Psychiatry Clinics (HOPE Therapeutics)
| ● | Execution of definitive Purchase Agreement and receipt of final regulatory clearance from Florida’s Agency for Health Care Administration (“ACHA”) to proceed with closing the acquisition of Dura Medical. |
| ● | Execution of binding letter of intent to acquire the assets of NeuroSpa TMS of Tampa, FL. |
| ● | Execution of a binding letter of intent to acquire a 49% interest in Cohen and Associates, LLC. |
| ● | Receipt of approval pending legal stipulations for $7.8 million of debt financing to support the acquisition of Dura Medical, NeuroSpa TMS, and Cohen Psychiatry. |
| ● | Execution of a definitive purchase agreement, subject to standard closing conditions and agreement between the parties regarding the resolution of ongoing discussions, to purchase the non-clinical assets of Kadima Neuropsychiatry Institute. |
| ● | Execution of a non-binding term sheet for a strategic investment from a global medical device manufacturer into HOPE. |
2. Going Concern
These condensed consolidated financial statements have been prepared on a going concern basis which contemplates the realization of assets and settlement of liabilities and commitments in the normal course of business. 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, 2025.The Company hasno revenues and expects to continue to incur operating losses at least through the remainder of2025.* Although the Company projects operating revenue to be derived from the operation of clinical facilities through its HOPE subsidiary and sales of its pharmaceutical products in2025, these projections are subject to completion of anticipated clinical acquisitions in thefirst 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.
8
As of* June 30, 2025,the Company had $2.9 million in cash and cash equivalents. On January 27, 2025,the Company entered into a securities purchase agreement (the “RD Purchase Agreement”) with the Investors for the sale by the Company of 1,215,278 shares (the “RD Shares”) of Common Stock to the Investors, at a purchase price of $2.88 per share, in a registered direct offering (the “Registered Direct Offering”). The closing of the sales of these securities under the RD Purchase Agreement occurred on or about January 29, 2025resulting in net proceeds to the Company of approximately $3.255 million after offering costs. The RD Warrants are exercisable forfive* years from the RD Closing Date.
Pursuant to the Purchase Agreement, on* January 28, 2025 (the “Third Closing Date”), the Company sold a total of $5.4 million in Notes subject to an original issue discount of 8% or $0.435 million less other issuance costs of $0.4 million noted below (the “Third Tranche Notes” and collectively with the First Tranche Notes and Second Tranche Notes, the ("Anson Notes")), with an aggregate purchase price of approximately $5.0 million, and Warrants to purchase up to 862,699 shares of Common Stock. The Company intends to use the net proceeds from these transactions for general corporate purposes, including the funding of certain capital expenditures (See Note7* and9).
On* April 17, 2025,the Company reinstated its At the Market Offering and increased the maximum aggregate offering amount and filed a prospectus supplement under the Offering Agreement for an aggregate of $20,000,000. During thethree* andsix months ended* June 30, 2025the Company sold an aggregate of 399,078 of its common stock shares for approximately $1.04 million, net of less than $0.03 million in offered costs. For more information regarding the Company’s At the Market Offering, please see Note9,* “Equity,” of these unaudited condensed consolidated quarterly financial statements.
The Company has 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. The Company* maypursue additional equity or debt financing or refinancing opportunities in2025* and2026 to fund ongoing clinical activities, to meet obligations under its current debt arrangements and for general corporate purposes. Such arrangements* maytake 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 leasttwelve* 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 accompanying condensed consolidated financial statements donot include any adjustments to reflect the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the company be unable to continue as a going concern.
3. Summary of Significant Accounting Policies
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 donot 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 condensed consolidated balance sheet, statements of operations and cash flows for the interim periods presented. The results of operations for any interim periods arenot 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 condensed 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 notes payable, fair value of warrant liabilities, fair value of stock options and warrants, fair value of the common stock shares granted for services, 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 arenot 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, butnot limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance onthird party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
9
Fair Value of Financial Instruments
FASB ASC Topic820, Fair Value Measurements(“ASC820**”), 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 inone of the followingthree categories for disclosure purposes:
Level1: Quoted prices in active markets for identical assets or liabilities.
Level2: Inputs other than Level1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level3: Unobservable inputs which are supported by little orno 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 Note11)
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 arenot 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, 2025the Company’s cash and cash equivalents balance within money market accounts was in excess of the U.S. federally insured limits by $2.4 million. The Company hasnot* 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 ofthree 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 Topic606, Revenue for Contract with Customers (“ASC606**”) or other accounting standards for revenuenot derived from customers. Arrangements* mayinclude 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* mayinclude licenses to intellectual property and research and development services. When such contractual arrangements are determined to be accounted for in accordance with ASC606,* 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.
10
The License Agreement (the “License Agreement”) with Alvogen Pharma US, Inc., Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (collectively, “Alvogen”) (as further discussed in Note6 below) was accounted for in accordance with ASC606. In accordance with ASC606, 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 ASC606, it performs the followingfive 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 thefive-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 ASC606, 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* mayprovide 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 arenot* 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* maybe 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 willnot* 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 Companyfirst 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 wouldnot 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.
11
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 Note6 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 recorded as prepaid assets and expensed when the activity has been performed or when the goods have been received.
Non-cancellable Contracts
The Company* mayrecord certain obligations as liabilities related to non-cancellable contracts. If appropriate, the offsetting costs may*be recorded as a deferred cost asset.
Convertible Notes Payable and Fair Value Election
As permitted under FASB ASC Topic825, Financial Instruments (“ASC825**”), the Company elected to account for its promissory notes, which meet the required criteria, at fair value at inception. Subsequent changes in fair value including interest and amortization of discounts are recorded as a component of non-operating loss in the condensed consolidated statements of operations. The portion of total changes in fair value of the notes 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 issuance of the promissory notes are expensed as incurred.
The Company estimates the fair value of its notes payable using a Monte Carlo simulation model, which uses as inputs the fair value of its Common Stock and estimates for the equity 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 estimates its expected future equity volatility based on the historical volatility of its Common Stock price 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 redemption features embedded in the notes. 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. Unless otherwise specified, the 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. Management believes those assumptions are reasonable but if these assumptions change, it could materially affect the fair value.
12
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 Topic480, Distinguishing Liabilities from Equity (“ASC480**”) and FASB ASC Topic815, Derivatives and Hedging (“ASC815**”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC480, meet the definition of a liability pursuant to ASC480, and whether the warrants meet all of the requirements for equity classification under ASC815, 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 donot 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 Company generally determines fair value of the Common Stock Warrants using a Black Scholes valuation methodology.
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 ASC480, the Company’s Series A Preferred Stock was classified as permanent equity as it wasnot mandatorily redeemable upon an event that is considered outside of the Company’s control. Further, in accordance with ASC815-40, Derivatives and Hedging–* Contracts in an Entity*’s Own Equity, the Series A Preferred Stock didnot 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 werenot bifurcated as a derivative under ASC815.
Segment Information
The Company’s Chief Operating Decision Maker (“CODM”) is its Chief Executive Officer, who reviews financial information presented for purposes of making operating decisions, assessing financial performance, and allocating resources. The Company operates as a single operating and reportable segment, consistent with the manner in which the CODM evaluates performance and allocates resources, see Note12 for further information.
Income Taxes
Income taxes are recorded in accordance with FASB ASC Topic740, Income Taxes (“ASC740**”), 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 thannot that some or all of the deferred tax assets willnot be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely thannot be realized assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely thannot 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.
13
Loss Per Share
The Company applies thetwo-class method when computing net income or loss per share attributable to common stockholders. In determining net income or loss attributable to common stockholders, thetwo-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 isno allocation required under thetwo-class method as the participating securities donot 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, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock options | 663,453 | 161,437 |
| Restricted stock awards | — | 66,666 |
| Common stock warrants | 9,536,222 | 4,069,240 |
| Common shares issuable upon conversion of Anson Notes | 3,716,836 | — |
Recent Accounting PronouncementsNot* Yet Adopted*
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.
In* December 2023,the FASB issued ASU2023*-09-Income Taxes (Topic740): Improvements to Income Tax Disclosures (“ASU2023*-09*”), which is intended to enhance the transparency and decision usefulness of income tax disclosures, primarily by amending disclosure requirements for the effective tax rate reconciliation and income taxes paid. ASU2023-09 should be applied on a prospective basis, and retrospective application is permitted. ASU2023-09 is effective for annual periods beginning after* December 15, 2024.Early adoption is permitted. The Company is currently evaluating the presentational impact of this ASU and expects to adopt its provisions in the Annual Report on Form10*-K for the year ending* December 31, 2025.*
In* November 2024,the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”)No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic220-40): Disaggregation of Income Statement Expenses* (“ASU2024-03”) and in* January 2025,the FASB issued ASUNo.* 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic220*-40): Clarifying the Effective Date*, which clarified the effective date of ASU2024-03. ASU2024-03 will require the Company to disclose the amounts of purchases of inventory, employee compensation, depreciation and intangible asset amortization, as applicable, included in certain expense captions in the Consolidated Statements of Operations, as well as qualitatively describe remaining amounts included in those captions. ASU2024-03 will also require the Company to disclose both the amount and the Company’s definition of selling expenses. The Company will adopt ASU2024-03 in its annual report for the year ended* December 31, 2026.*
14
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, 2025 | December 31, 2024 | |
|---|---|---|
| (Unaudited) | ||
| Prepaid expense and other current assets: | ||
| Prepaid insurance | $829 | $827 |
| Prepaid clinical development costs | 761 | 824 |
| Other prepaid expense | 90 | 208 |
| Total prepaid expense and other current assets | $1,680 | $1,859 |
5. Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following at the dates indicated (in thousands):
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| (Unaudited) | ||
| Accrued and other current liabilities: | ||
| Refund liability (see Note 6) | $4,715 | $4,715 |
| Professional services | 4,177 | 3,732 |
| Employee costs | 442 | 577 |
| Accrued research and development expense | 587 | 655 |
| Other accrued expense | 53 | 470 |
| Total accrued and other current liabilities | $9,974 | $10,149 |
6. Alvogen Licensing Agreement
In* June**2023,* the Company entered into a License Agreement with Alvogen as disclosed in previous filings. 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 hasnot* been reclassified to deferred revenue or recorded as revenue as of* June 30, 2025*and will remain permanent as refund liability until settled.
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, 2025,the refund liability due to Alvogen was $4.7 million, which represents all payments made by Alvogen through June 30, 2025,and is included as a component of accrued expense and other current liabilities on the condensed consolidated balance sheet (refer to Note5*). Following the early termination by Alvogen, the Company doesnot anticipate recognizing any revenue under the License Agreement. Additionally, in* June 2024*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.
7. Debt
Streeterville Convertible Note
On* November 4, 2022,the Company issued the Streeterville Note, for an aggregate principal amount of $11.0 million. The note was accounted for under the fair value option of ASC 825. All material terms of the Streeterville note have been disclosed in prior filings. As previously disclosed, on April 24, 2024,the Company received written notice from counsel for Streeterville that an alleged event of default occurred with respect to the Note issued by the Company in favor of Streeterville (the “Notice”). On August 12, 2024,the Company and Streeterville entered into a Settlement and Release of Claims (the “Settlement Agreement”), whereby the Company and Streeterville agreed to settle all disputes between the parties and release the Company from all obligations to Streeterville under the terms of the Streeterville Notes in exchange for a payment of $2.5 million upon the initial closing of the sale of the Anson Notes, and within60* days thereafter, asecond payment of $3.1 million. The Company made the $2.5 million payment upon the Anson Notes closing on* August 15, 2024.The Company made the final $3.1 million payment in October 10, 2024*using proceeds from the Second Closing of Anson Convertible Promissory Note.
15
The Company evaluated the terms of the Settlement Amendment in accordance with ASC470-50, Debt Modifications and Extinguishments. Both the Settlement Amendment and the Third Amendment (considered cumulatively with the Settlement Amendment) were deemed to be debt modifications and didnot give rise to a debt extinguishment in accordance with ASCTopic 470,*Debt, which will be accounted for prospectively. The modifications didnot* result in recognition of a gain or loss in the condensed consolidated statements of operations as the modifications werenot considered debt extinguishments, but will impact interest expense and the determination of fair value in future periods.
As of* June 30, 2025and December 31, 2024,the Note carried a remaining principle balance of $0 million. Refer to Note11* for the reconciliation of the fair values for the periods presented.
Anson Convertible Promissory Notes
On* August 12, 2024,*the Company entered into the Purchase Agreement with the Investors. The Company agreed to sell, inthree equal tranches, original issue discount Anson Notes in the aggregate principal amount of up to approximately $16.3 million for an aggregate purchase price of up to approximately $15.0 million and warrants to purchase that amount of shares equal to 50% of the principal amount of the Notes divided by the VWAP of the Company’s Common Stock, as listed on the Nasdaq Capital Market, on the day prior to the closing of each respective tranche under the Anson Warrants.
In connection with the above offering, the Company engaged EF Hutton LLC as placement agent (the “Placement Agent”), Pursuant to the terms of the engagement with the Placement Agent, the Company paid a cash fee of 7% of the gross proceeds the Company receives in the offering at closing.
2024 Senior Secured Convertible Promissory Notes
On* August 14, 2024,the Company entered into thefirst* tranche Senior Secured Convertible Note Agreements (the “First Tranche Notes”) with Anson Investment Master Fund LP and Anson East Master Fund LP (collectively “Anson”) at various amounts for an aggregate of $5.4 million subject to an original issuance discount of 8% or $435,000, less other cash issuance costs of $521,000, resulting in net cash proceeds of $4.5 million, prior to any allocation to the Anson Warrants. The First Tranche Notes bear interest at a rate of 6% per annum (or 10% during the occurrence of any Event of Default (as defined in the First Tranche Notes)) and have a term of 15 months from the issuance date, maturing on* November 14, 2025 (the “First Tranche Maturity Date”) (see Note9*). $2.5 million of the proceeds from the First Tranche Notes were used to make an initial payment to partially satisfy the Streeterville note in2024.
On* August 14, 2024,*in conjunction with the issuance of the First Tranche Notes, the Company issued warrants to purchase up to 1,349,305 shares of the Company’s Common Stock.
The First Tranche Notes are convertible at the option of the holder at any time after issuance into Common Stock, at a per share conversion price equal to the lower of (a) $2.4168, (the “Fixed Conversion Price”) or (b) a price equal to 92% of the lowest VWAP during theseven trading day period immediately preceding the effective conversion date (the “Alternate Conversion Price”, and together with the Fixed Conversion Price, the “Conversion Price”). If the Conversion Price is less than $0.38 (the “Floor Price”), then in addition to the issuance of Common Stock upon conversion the Company will pay cash as a true-up which is determined by the product of (i) the difference between (y) the Floor Price less (z) the Conversion Price then in effect, multiplied by (ii) the conversion amount that is being paid in Common Stock.
The terms of the First Tranche Notes donot allow any conversion of the First Tranche Notes if it results in Anson owning more than4.99% of the outstanding shares of Common Stock (the "Beneficial Ownership Limitation"). This limitation can be adjusted up to9.99% with prior notice, effective61 days after such notice. Anson must ensure compliance with this limitation when submitting a notice of conversion, and the Company will rely on Anson's representation of compliance.
16
If the Company issues or grants options for Common Stock at a price lower than the current Conversion Price, the Conversion Price will be adjusted to match this lower price, (the “Base Conversion Price”). The Company must notify Anson of any such issuance, and Anson is entitled to convert shares based on the new Base Conversion Price.
If the Company offers purchase rights to holders of Common Stock, Anson will be entitled to acquire those rights as if they had fully converted the Note, subject to the Beneficial Ownership Limitation. If exercising these rights would exceed the Beneficial Ownership Limitation, the rights will be held in abeyance until they can be exercised without exceeding the limit.
The First Tranche Notes contain mandatory redemption features, whereby if at any time the First Tranche Notes are outstanding, the Company will be required to: (A) use up to30% of the gross proceeds from any Subsequent Financings (as defined in the Purchase Agreement) in cash, to redeem all or a portion of the Note for an amount equal to the outstanding principal, plus all accrued but unpaid interest, plus all liquidated damages (the “Redemption Obligations”), multiplied by1.05 (the “Mandatory Redemption Amount”); (B) redeem all of the Redemption Obligations at the Mandatory Redemption Amount in the event of a Change of Control Transaction (as defined in the First Tranche Notes); (C) redeem the Redemption Obligations for the Mandatory Redemption Amount in the event a registration statement isnot available for each of the offer and resale of the shares issuable upon conversion of the First Tranche Notes (the “Conversion Shares”); and (D) redeem the Redemption Obligations for the Mandatory Redemption Amount if the Shareholder Approval isnot obtained within180 days following the date of issuance of the First Tranche Notes.
The First Tranche Notes contain certain covenants, and events of default and triggering events, respectively, which would require repayment of the obligations outstanding pursuant to such instruments. The obligations of the Company pursuant to the First Tranche Notes are (i) secured by all assets of the Company and all subsidiaries of the Company pursuant to the Security Agreement and Patent Security Agreement, dated* August 14, 2024,by and among the Company, the subsidiaries of the Company, and the Investors, and (ii) guaranteed jointly and severally by the subsidiaries of the Company pursuant to the Subsidiary Guarantee, dated August 14, 2024,*by and among the Company, the subsidiaries of the Company, and the Investors.
Pursuant to the Purchase Agreement, on* October 10, 2024 (the “Second Closing Date”), the Company sold a total of $5.4 million in Notes (the “Second Tranche Notes”), subject to an original issue discount of 8% or $435,000 less other cash issuance cost of $375,000, with an aggregate purchase price of approximately $5.0 million, and Warrants to purchase up to 1,846,128 shares of Common Stock. The Second Tranche Notes are convertible into Common Stock, at a per share conversion price equal to by the lower of (a) $1.7664 or (b) a price equal to 92% of the lowest VWAP during theseven* trading day period immediately preceding the effective date set forth in a Notice of Conversion delivered by an Investor to the Company. The Conversion Price is subject to, among other customary provisions, downward adjustment in the event of any future issuance by the Company of common stock below the then effective Conversion Price. $3.1 million of the proceeds from the Second Tranche Notes were used to satisfy the remaining amount due in connection with the Streeterville note.
In connection with the above Second Tranche Notes, the Company engaged Placement Agent. Pursuant to the terms of the engagement with the Placement Agent, the Company paid a cash fee of 7% of the gross proceeds the Company received in the Third Closing and incurred certain additional other issuance costs and reimbursement for legal counsel disbursements and placement agent, for aggregate issuance costs of approximately $0.4 million.
Pursuant to the Purchase Agreement, on* January 28, 2025 (*the “Third Closing Date”), the Company sold a total of $5.4 million in Notes subject to an original issue discount of 8% or $0.435 million less other issuance costs of $0.4 million noted below (the “Third Tranche Notes” and collectively with the First Tranche Notes and Second Tranche Notes, the ("Anson Notes")), with an aggregate purchase price of approximately $5.0 million, and Warrants to purchase up to 862,699 shares of Common Stock. The Third Tranche Notes are convertible into Common Stock, at a per share conversion price equal to by the lower of (a) $3.78 or (b) a price equal to 92% of the lowest VWAP during theseven trading day period immediately preceding the effective date set forth in a Notice of Conversion delivered by an Investor to the Company. The Conversion Price is subject to, among other customary provisions, downward adjustment in the event of any future issuance by the Company of common stock below the then effective Conversion Price.
In connection with the above Third Tranche Notes, the Company paid a cash tail fee to the Placement Agent equal to 7% of the gross proceeds the Company received in the Third Closing and incurred certain additional other issuance costs and reimbursement for legal counsel disbursements, for aggregate issuance costs of approximately $0.4 million.
17
On or about* January 27, 2025,the Company and the Investors entered into a Consent and Waiver Agreement (the “CWA”), relating to certain rights and prohibitions arising under the Purchase Agreement and the Notes. In the CWA, each of the Investors provided its consent under certain restrictive provisions, and waived certain rights, including, among other things, a right to participate in certain Qualified Financings (as defined in the CWA) made by us under the Purchase Agreement and the Notes, the prohibition on issuance of certain equity securities, and waiver of any potential liquidated damages arising under that certain Registration Rights Agreement by and between the Company and the Investors dated August 14, 2024,until March 31, 2025.On March 20, 2025,following the conversion of less than $0.1 million of the Third Tranche Note into 5,463 shares of common stock, the Company issued 303,819 shares of common stock Consideration Shares and 303,819 of Consideration Warrants to Anson in accordance with the terms of the CWA (See Note9*).
Due to these embedded features within the Anson Notes, the Company elected to account for the First, Second, and Third Tranche Notes at fair value at inception. Subsequent changes in fair value are recorded as a component of other income (loss) in the condensed consolidated statements of operations. Additionally, the portion of changes in the fair value related to changes in credit risk are recorded to other comprehensive income in the condensed consolidated statements of operations. To determine the initial carrying value of the Notes and the warrants issued to Anson under the First, Second, and Third Tranche Notes (see Note9), the Company allocated the proceeds using the fair value method. After allocation, the initial carrying value of the First Tranche Notes and the warrants issued to Anson were $2.9 million and $2.1 million, respectively, the initial carrying value of the Second Tranche Notes and the warrants issued to Anson were $3.1 million and $1.9 million, and the initial carrying value of the Third Tranche Notes and the warrants issued to Anson were $2.5 and $2.5 respectively. Refer to Note11 for the reconciliation of the fair values for the periods presented.
During thethree months ended* March 31, 2025,Anson converted $1.3 million and less than $0.1 million of principal and interest of the First and Third Tranche Notes, respectively, into common stock, resulting in the aggregate issuances of 1,009,518 shares of Common Stock and loss on conversion of $1.6 million. During thethree* month ended* June 30, 2025Anson converted $4.1 million of principal and interest of the Third Tranche Note into common stock, resulting in the issuance of 1,879,406 shares of Common Stock and loss on conversion of $1.9 million. During the year ended December 31, 2024,Anson converted $4.2 million of principal and interest of the First Tranche Note into common stock, resulting in the issuances of 3,676,796 shares of Common Stock and loss on conversion of $1.3 million. (see Note9*). As of* June 30, 2025,the nominal principal and accrued interest balance of the Anson Notes was $9.26 million and $0.3 million, respectively. During thethree* andsix months ended* June 30, 2025 ,the Company recorded a loss from the change in fair value of the Second and Third Tranche Notes of $5.6 million and $6.5 million, which was recognized in other expense (income) on the condensed consolidated statements of operations as a result of the Company’s election of the fair value option. At June 30, 2025,the effective interest rates of the Second and Third Tranche Note was 4.6% and 45.7%, respectively. See Note11,* “Fair Value Measurements,” for a summary of activity for the Anson Notes.
18
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* maybe reduced by 25% in certain circumstances, and by the application of certain sub-license fees. As of June 30, 2025,the total cumulative payments made under theSHMH License Agreement* were $0.5 million, with $0.2 million in payments made during thethree andsix months ended* June 30, 2025.There wereno payments made during thethree* andsix months ended* June 30, 2024.*
Royalties
A royalty in an amount equal to: (a)1% of revenues from the sale of any product incorporating a Licensed Product when at leastone Licensed Patent remains in force, if such product isnot 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 leastone 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 hasnot been finally invalidated or held to be unenforceable. The royalty rates above* maybe 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 donot* 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 thethree andsix months ended* June 30, 2025and2024,* no royalty payments were made.
Annual Maintenance Fee
A fixed amount of $100,000 was paid on* April 16, 2021and, thereafter, a fixed amount of $150,000 is due on the anniversary of such date during the term of the SHMH License Agreement. During thethree* andsix months ended* June 30, 2025and2024,* the company recorded $150,000 and $0 in related annual maintenance fee, respectively.
Exclusive License Agreement
The Company has entered into a License Agreement with Apkarian Technologies to in-license US Patent8,653,120 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 thethree andsix months ended* June 30, 2025and2024,* the Company has recordedno expenses relating to the licensure of the patent.
Kadima and Dura Purchase Agreements
On* March 29, 2025,the Company entered into certain Membership Interest Purchase and Contribution Agreement (the “Dura Purchase Agreement”), by and among the Subsidiaries, Dura Medical, LLC, and Stephen Durand, CRNA, APRN. Under the terms of the Dura Purchase Agreement, the Company agreed to acquire100%* of the membership interests in Dura Medical, LLC. The transaction includes a combination of cash consideration, contingent earn-out payments based on future performance metrics, and post-closing adjustments. The Dura Purchase Agreement also includes customary representations and warranties, indemnification provisions, and restrictive covenants including non-competition and non-solicitation clauses. The closing of the transaction is subject to customary conditions precedent, including regulatory approvals andthird-party consents. The Company expects the acquisition to enhance its operational capabilities in the healthcare sector and contribute to long-term strategic growth.
On* May 9, 2025,*in furtherance of the Company’s previously announced plans for its subsidiary, HOPE Therapeutics, Inc. (“Hope”), to develop a national network of precision psychiatry clinics. Hope and its wholly-owned subsidiary, HTX Management Company, LLC (“HTX”, and collectively with Hope, the “Subsidiaries”), entered into an Asset Purchase and Contribution Agreement (the “Kadima Purchase Agreement”), with Kadima Neuropsychiatry Institute, Medical Corp. (“Kadima Medical”), Kadima Holdings, Inc. (“Kadima Holdings”), and David Feifel, M.D., PH.D (“Feifel”, and collectively with Kadima Medical and Kadima Holdings, “Kadima”).
The Kadima Purchase Agreement contains representations, warranties and covenants of the Company and Kadima that are customary for a transaction of this nature, including among others, covenants by Kadima regarding the validity of certain material contracts entered into between Kadima andthird-parties being assigned to the subsidiaries, title to the assets being sold by Kadima, the condition and sufficiency of the assets being purchased, and Kadima’s rights to its intellectual property, tax liabilities, the investment representations of Kadima, and other open matters in discussions regarding resolution with the intent to close the transaction.
19
The Purchase Agreement also contains customary indemnification provisions whereby Kadima will indemnify the Company for certain losses arising out of inaccuracies in, or breaches of, the representations, warranties and covenants of Kadima, pre-closing taxes of Kadima, and certain other matters, subject to certain caps and thresholds.
The foregoing description of the Kadima Purchase Agreement doesnot purport to be complete and is qualified in its entirety by the full text of the Kadima Purchase Agreement, a copy of which is filed as Exhibit10.6 of the Company’s Quarterly Report on Form10-Q as of* March 31, 2025.The Kadima Purchase Agreement was previously attached to provide investors with information regarding its terms. It isnot* intended to provide any other factual information about the Subsidiaries or Kadima. In particular, the assertions embodied in the representations and warranties contained in the Purchase Agreement are qualified by information in the confidential disclosure schedules (the "Disclosure Schedules") provided by Kadima in connection with the consummation of the transactions contemplated by the Kadima Purchase Agreement. These Disclosure Schedules contain information that modifies, qualifies and creates exceptions to the representations and warranties and certain covenants set forth in the Kadima Purchase Agreement. Moreover, certain representations and warranties in the Kadima Purchase Agreement were used for the purposes of allocating risk between the subsidiaries and Kadima, rather than establishing matters of fact. Accordingly, the representations and warranties in the Kadima Purchase Agreement shouldnot be relied on as characterization of the actual state of facts regarding the Subsidiaries and/or Kadima.
As of the date of this Report, the transactions contemplated by each of the Dura Purchase Agreement and the Kadima Purchase Agreement havenot yet been consummated, and, as disclosed below, with respect to Kadima the parties are working to close the transaction on terms contemplated by the Kadima Purchase Agreement or pursue an alternative outcome acceptable to the parties.
Operating Lease
The Company leases office space on a month-to-month basis. The rent expense for thethree andsix months ended* June 30, 2025and2024* was less than $0.1 million and $0.1 million, respectively.
Legal Proceedings
The Company is, from time to time, involved in various legal proceedings incidental to the conduct of our business. Historically, the outcome of nearly all such legal proceedings hasnot, in the aggregate, had a material adverse effect on our business, financial condition, results of operations or liquidity. Other than as set forth below, there areno material pending or threatened legal proceedings at this time.
On* May 9, 2025,Hope entered into the Kadima Purchase Agreement (the “Agreement”), with HTX Management Company, LLC, Kadima Neuropsychiatry Institute, Medical Corp., Kadima Holdings, Inc., and David Feifel, M.D., PH.D. (collectively, “Kadima”), pursuant to which the Company agreed to purchase, and Kadima agreed to sell, on the Closing Date, as defined in the Agreement, certain assets of Kadima, subject to the satisfaction of certain closing conditions (the “Acquisition”). As of the date of this Report, the parties havenot* closed the Acquisition, and, whileno assurances can be given, remain in active discussions to either i) close the Acquisition per the terms of the Agreement, or ii) pursue potential alternative outcomes mutually agreeable to all parties.
9. Equity
Preferred Stock
Pursuant to the terms of the Company’s Second Amended and Restated Certificate of Incorporation, the Company has50,000,000 shares of preferred stock authorized 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 3.0 million shares of Series A Preferred into 300,000 shares of Common Stock. As of June 30, 2025,*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, 2024to July 29, 2024,the Company announced that it entered into multiple purchase agreements (the “ATM Purchase Agreements”) subject to standard closing conditions where accredited investors purchased 385,515 shares of unregistered Common Stock at a range of $2.42 – $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. The Company suspended the At the Market Offering from August 14, 2024through April 17, 2025.On April 17, 2025,the Company reinstated the At the Market Offering and increased the maximum aggregate offering amount and filed a prospectus supplement under the Offering Agreement for an aggregate of $20,000,000. During thesix* andthree months ended* June 30, 2025the Company sold an aggregate of399,078* of its common stock shares for approximately*$1.04* million, net of $0.03 million in offered costs.
20
On* February 27, 2024,the Company entered into an underwriting agreement (the “* FebruaryUnderwriting Agreement”) with EF Hutton LLC (the “Representative”), as the representative of the several underwriters named therein (the “** FebruaryUnderwriters”), relating to an underwritten public offering (the “** February 2024Public Offering”) of 500,000 shares (the “** FebruaryShares”) of the Company’s Common Stock. The public offering price for each share of Common Stock was $3.00 and the* FebruaryUnderwriters purchased the shares of Common Stock pursuant to the FebruaryUnderwriting Agreement at a price for each share of Common Stock of $2.76. Pursuant to the FebruaryUnderwriting Agreement, the Company also granted the Representative a45*-day option to purchase up to an additional 75,000 shares (the “** FebruaryOption Shares”) of the Common Stock on the same terms as the* FebruaryShares sold in the February 2024Public Offering (the “** FebruaryOver-Allotment Option*”). On* February 28, 2024,the February 2024Public Offering closed (the “** FebruaryClosing Date*”). The aggregate net cash proceeds to the Company from the* February 2024Offering proceeds were approximately $1.3 million after offering costs of approximately $0.4 million. On March 5, 2024,the FebruaryUnderwriters of the previously announced underwritten public offering of the Company exercised their option in accordance with the FebruaryUnderwriting 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 “* FebruaryOverallotment Exercise”). The* FebruaryOverallotment 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* February29,* 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 “ FebruaryWarrants”) 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 2024Public Offering. The Common Stock and the FebruaryWarrants were offered pursuant to a private placement (the “** February 2024Private Placement*”) under Section4(a)(2) of the Securities Act of1933, as amended (the “Securities Act”). The aggregate net cash proceeds to the Company from the* February 2024*Private Placement were approximately $1.0 million.
OnApril 18, 2024, the Company entered into an underwriting agreement (the “** AprilUnderwriting Agreement”) with the Representative, as the representative of the several underwriters named therein (the “** AprilUnderwriters”), relating to an underwritten public offering (the “** April 2024Public Offering”) of 607,000 shares (the “** AprilShares”) of Common Stock. The public offering price for each share of Common Stock was $3.30. Pursuant to the* AprilUnderwriting Agreement, the Company also granted the Representative a45*-day option to purchase up to an additional 91,050 shares (the “** AprilOption Shares”) of the Common Stock on the same terms as the* AprilShares sold in the April 2024Public Offering (the “** AprilOver-Allotment Option*”). OnApril 19, 2024, the Offering closed (the “** AprilClosing Date”). Net proceeds from the* April 2024Public Offering were approximately $1.6 million after offering costs of approximately $0.4 million. On May 23, 2024,the AprilUnderwriters of the previously announced underwritten public offering of the Company exercised their option in accordance with the AprilUnderwriting 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 “* AprilOverallotment Exercise”). The* AprilOver-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.
On* August 28, 2024,the Company issued 20,000 shares of Common Stock in relation to consulting services performed by athird* party. The fair value of the Common Stock on the date of issuance was less than $0.1 million.
During the year ended* December 31, 2024,Anson converted $4.2 million of principal and interest of the First Tranche Note into common stock, resulting in the issuances of 3,676,796 shares of Common Stock valued at $5.5 million based on the market price of our common stock at the date of common stock issuance resulting in a loss on conversion of $1.3 million (see Note7*).
21
On* January 27, 2025,the Company entered into a securities purchase agreement (the “RD Purchase Agreement”) with the Investors for the sale by the Company of 1,215,278 shares (the “RD Shares”) of Common Stock to the Investors, at a purchase price of $2.88 per share, in a registered direct offering (the “Registered Direct Offering”). Concurrently with the sale of the RD Shares, pursuant to the RD Purchase Agreement the Company also sold to the investors unregistered Common Stock purchase warrants (the “RD Warrants”) to purchase up to an aggregate of 1,215,278 shares of Common Stock (the “RD Warrant Shares”), in a private placement. Subject to certain beneficial ownership limitations, the RD Warrants are immediately exercisable upon issuance at an exercise price equal to $2.88 per share of Common Stock, subject to adjustments as provided under the terms of the RD Warrants. The closing of the sales of these securities under the RD Purchase Agreement occurred on or about January 29, 2025 (*the “RD Closing Date”), resulting in net proceeds to the Company of approximately $3.255 million after offering costs. The RD Warrants are exercisable forfive years from the RD Closing Date. The Company intends to use the net proceeds from the transactions for general corporate purposes, including the funding of certain capital expenditures.
On or around* January 27, 2025,the Company and Anson entered into a Consent and Waiver Agreement (CWA) related to the RD Purchase Agreement and the Notes. Under this agreement, the investors agreed to waive certain rights and restrictions, including their right to participate in certain future financings, restrictions on the Company issuing specific equity securities, and any potential liquidated damages under the Registration Rights Agreement dated August 14, 2024.These waivers are effective through and expired as of March 31, 2025.*
As consideration for these waivers, the Company agreed to issue additional compensation to the investors if the volume-weighted average price (VWAP) of the Company’s common stock is lower than the original purchase price at the time investors submit theirfirst conversion notice for Notes issued in the Second or Third Closing. This compensation includes additional shares of common stock (the "Consideration Shares") and warrants to purchase an equal number of shares (the "Consideration Warrants"). The exercise price of the warrants is based on a VWAP-Based Adjustment, calculated as the greater of (a) the VWAP on the trading day before the conversion notice, or (b)80% of the closing price on the day before the Registered Direct Offering. As of* June 30, 2025,the obligation under this provision has been fully satisfied. On March 20, 2025,*following the conversion of less than $0.1 million of the Third Tranche Note into 5,463 shares of common stock, the Company issued 303,819 shares of common stock Consideration Shares and 303,819 of Consideration Warrants to Anson in accordance with the terms of the CWA.
The gross proceeds to the Company from the offerings were approximately $3.5 million, before deducting offering expenses of $0.2 million and excluding the proceeds, if any, from the exercise of the RD Warrants. As discussed above, on* January 29, 2025,in conjunction with the issuance of the RD Shares, the Company issued RD Warrants to purchase up to 1,215,278 shares of the Company’s Common Stock which were classified as a liability. The RD Warrants have an exercise price of $2.88 per share and have a contractual term offive years expiring on January 29, 2030.The measurement of fair value of the RD Warrants were determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $2.07, exercise price of $2.88, term offive years, volatility of 115.8%, and risk-free rate of 4.00%). The grant date fair value of these RD Warrants was estimated to be $3.983 million on January 29, 2025.As the fair value of the liabilities exceeded the net proceeds received of $3.255 million, the Company recognized the excess of the fair value over the net proceeds received of $3.255 million as a loss upon issuance of RD Shares of $0.7 million which is included in other expense (income) in the condensed consolidated statement of operations for thesix* months ended* June 30, 2025.*
During thefirst quarter of fiscal2025, Anson converted $1.3 million of principal and interest of the First Tranche Note into common stock, resulting in the issuance of 1,004,055 shares of Common Stock valued at $2.9 million based on the market price of our common stock at the date of the common stock issuance resulting in a loss on conversion of $1.6 million (See Note7).
During thefirst quarter of fiscal2025, Anson converted less than $0.1 million of principal and interest of the Third Tranche Note into common stock, resulting in the issuance of 5,463 shares of Common Stock valued at less than $0.1 million based on the market price of our common stock at the date of the common stock issuance resulting in a loss on conversion of less than $0.1 million (See Note7).
During thesecond quarter of fiscal2025, Anson converted $4.1 million of principal and interest of the Third Tranche Note into common stock, resulting in the issuance of 1,879,406 shares of Common Stock valued at $6.0 million based on the market price of our common stock at the date of the common stock issuance resulting in a loss on conversion of $1.9 million (See Note7).
22
On* March 20, 2025,following the conversion of less than $0.1 million of the Third Tranche Note into 5,463 shares of common stock, the Company issued 303,819 shares of common stock Consideration Shares and 303,819 of Consideration Warrants to Anson in accordance with the terms of the CWA. As a result of this adjustment, the exercise price of the RD Warrants was updated to $2.30 as of March 20, 2025.Upon conversion or extinguishment, ASC470*-50-40-2 requires that any difference between the carrying amount of the debt and the fair value of consideration transferred be recognized as a gain or loss in the statement of operations. The Consideration Shares, being equity-classified, are recognized at fair value with credit to common stock and additional paid in capital. The Consideration Warrants, liability-classified under ASC815-40, were initially recognized at fair value, with changes in fair value subsequently recognized through earnings. In accordance with the CWA, the Company recorded loss on issuance of the Consideration shares and the Consideration Warrants in total of $1.277 million recognized within other expense (income) during thesix months ended* June 30, 2025,*within accompanying condensed consolidated statements of operations and comprehensive loss.
On* May 15, 2025,the Company granted 75,000 shares of fully vested common stock to a vendor in accordance with the vendor agreement. The value of the fully vested shares granted was determined by the value of the stock on the quoted trading price of $2.08 and an aggregate of approximately $0.2 million was recorded as expense within the accompanying condensed consolidated statement of operations for thethree* andsix month ended* June 30, 2025.*
Common Stock Warrants
Substitute Warrants
In connection with the Merger in2021, 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 Topic815, 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 condensed 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 Topic820, with changes in fair value recognized in the statements of operations in the period of change. Refer to Note11 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 purchaseone-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 expirefive years after the effective time on or earlier upon their redemption or liquidation of the Company.
During thethree andsix months ended* June 30, 2025and2024* no Public Warrants were exercised. The outstanding balance of these public warrants remains in equity. At* June 30, 2025and December 31, 2024,*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 arenot indexed to the Company’s common shares in the manner contemplated by FASB ASC Topic815-40-15 because the holder of the instrument isnot 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, 2025and December 31, 2024.*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 gain on the change in fair value of the Private Placement Warrants for thethree andsix months ended* June 30, 2025and2024.* Refer to Note11 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 FebruaryWarrants to purchase up to 270,000 shares of Common Stock which were classified in stockholder’s equity. The FebruaryWarrants have an exercise price of $3.80 per share, are initially exercisable beginningsix* 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.
23
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 “* FebruaryUnderwriter Warrant Shares”). The Underwriter’s Warrant is exercisablesix months following the date of the Underwriting Agreement and terminates on thefive-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 AprilUnderwriter’s Warrant to purchase up to 30,350 shares of Common Stock (the “** AprilUnderwriter Warrant Shares*”). The* AprilUnderwriter’s Warrant is exercisablesix months following the date of the Underwriting Agreement and terminates on thefive-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 Note6, on* February 7, 2024the 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 mayalso be exercised on a cashless basis if there isno* 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* maybe waived up to a maximum of 9.99% at the election of the holder, withnot* less than61 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.
Anson Warrants
The Anson Warrants, originally issued in the Purchase Agreement, are recognized as derivative liabilities in accordance with ASC815. The Company concluded liability classification was appropriate as certain settlement features included in the Anson Warrants arenot indexed to the Company's own stock, and therefore preclude equity classification. Accordingly, the Company recognizes the warrant instruments as liabilities at fair value and adjusts the instruments to fair value at each reporting period. The liabilities are subject to re-measurement at each balance sheet date until exercise or expiration, and any change in fair value is recognized in the Company’s condensed consolidated statements of operations. The Anson Warrants were initially measured at fair value using a Black-Scholes model and have subsequently been measured based on the listed market price of such warrants. Warrant liabilities are classified as current liabilities on the Company's condensed consolidated balance sheets. On* August 14, 2024,in conjunction with the issuance of the First Tranche Notes, the Company issued warrants to purchase up to 1,349,305 shares of the Company’s Common Stock which were classified as a liability. The warrants have an exercise price of $2.4168 per share, subject to adjustment or other settlement provisions, and have a contractual term offive years expiring on August 14, 2029.The measurement of fair value of the Investor Warrants were determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $1.86, exercise price of $2.42, term offive years, volatility of 122%, and risk-free rate of 3.67%, and expected dividend rate of 0%). The grant date fair value of these Investor Warrants was estimated to be $2.1 million on August 14, 2024.*
24
On* October 10, 2024,in conjunction with the issuance of the Second Tranche Notes, the Company issued warrants to purchase up to 1,846,128 shares of the Company’s Common Stock which were classified as a liability. The warrants have an exercise price of $1.7664 per share, subject to adjustment or other settlement provisions, and have a contractual term offive years expiring on October 10, 2029.The measurement of fair value of the Investor Warrants was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $1.38, exercise price of $1.76, term offive years, volatility of 105%, and risk-free rate of 3.91%, and expected dividend rate of 0%). The grant date fair value of these Second Tranche Investor Warrants was estimated to be $1.9 million on October 10, 2024.*
On* January 28, 2025,in conjunction with the issuance of the Third Tranche Notes, the Company issued warrants to purchase up to 862,699 shares of the Company’s Common Stock which were classified as a liability (See Note11*). The warrants have an exercise price of $3.78 per share, subject to adjustment or other settlement provisions, and have a contractual term offive years expiring on* January 28, 2030.The measurement of fair value of the Investor Warrants was determined using a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $3.55, exercise price of $3.78, term offive years, volatility of 113%, risk-free rate of 4.33%, and expected dividend rate of 0%). The grant date fair value of these Third Tranche Investor Warrants was estimated to be $2.5 million on January 28, 2025.*
As discussed above, on* January 29, 2025,in conjunction with the issuance of the RD Shares, the Company issued RD Warrants to purchase up to 1,215,278 shares of the Company’s Common Stock which were classified as a liability. The RD Warrants have an exercise price of $2.88 per share and have a contractual term offive years expiring on January 29, 2030.The measurement of fair value of the RD Warrants were determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $2.07, exercise price of $2.88, term offive years, volatility of 115.8%, and risk-free rate of 4.00%). The grant date fair value of these RD Warrants was estimated to be $3.983 million on January 29, 2025.As the fair value of the liabilities exceeded the net proceeds received of $3.255 million, the Company recognized the excess of the fair value over the net proceeds received of $3.255 million as a loss upon issuance of RD Shares of $0.7 million which is included in other expense (income) in the condensed consolidated statement of operations for thesix* months ended* June 30, 2025.*
As discussed above, on* March 20, 2025,in conjunction with the issuance of the Consideration Shares, the Company issued Consideration Warrants to purchase up to 303,819 shares of the Company’s Common Stock which were classified as a liability. The Consideration Warrants have an exercise price of $2.88 per share and have a contractual term offive years expiring on March 20, 2030.*
The measurement of fair value of the Consideration Warrants were determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $2.07, exercise price of $2.88, term offive years, volatility of 115.8%, and risk-free rate of 4.00%). The grant date fair value of these Consideration Warrants was estimated to be $0.6 million on* March 20, 2025.*
As of* June 30, 2025,the aggregate fair value of all liability classified warrants, which include Anson Warrants, RD Warrants and Private Placement Warrants, was $16.3 million. The Company recognized a loss on the change in fair value of the liability classified warrants for thethree* andsix months ended* June 30, 2025of approximately $6.4 million and $3.5 million, respectively. Refer to Note11* for discussion of the fair value measurement of the Company’s warrant liabilities.
25
The following table provides the activity for all warrants for the respective periods.
| Aggregate | ||||
|---|---|---|---|---|
| Weighted · Weighted · Intrinsic | ||||
| Average · Average · Value | ||||
| Total Warrants | Remaining Term | Exercise Price | (in thousands) | |
| Outstanding as of December 31, 2023 | 3,321,499 | 3.91 | $23.01 | $180 |
| Issued | 3,948,484 | 4.71 | 2.04 | — |
| Expired | (96,417) | — | — | — |
| Outstanding as of December 31, 2024 | 7,173,766 | 3.77 | $17.20 | $80 |
| Issued | 2,381,796 | 5.00 | 2.86 | — |
| Expired | (19,340) | — | — | — |
| Outstanding as of June 30, 2025 | 9,536,222 | 3.61 | $8.52 | $530 |
10. Stock-Based Compensation
2016 Omnibus Incentive Plan
Prior to the Merger, NRx maintained its2016 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 the2016 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, 2025,1,050,809 shares of Common Stock are authorized for issuance pursuant to awards under the Company’s2021* Omnibus Incentive Plan (the “2021 Plan”). As of* January 1, 2025,95,528 shares were added to the2021* 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, 2022and 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,thefirst* amendment to the2021 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* maybe delivered pursuant to the exercise of Incentive Stock Options granted under the Plan to be equal to100%* of the Share Pool. As of* June 30, 2025,an aggregate 1,117,099 shares have been awarded net of forfeitures, and 18,085 shares remain available for issuance under the2021* Plan. The2021 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 iszero based on the fact that the Company has never paid cash dividends and doesnot 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 forNRX‑101, or b) immediately preceding a change in control of the Company, whichever occurs first.
On* February 7, 2025,the Company issued 50,000 stock options. These shares have a vesting term ofthree* years, an expiration date often years from the grant date, and were valued at approximately $0.1 million as of the grant date.
On* April 9, 2025,*the Company issued 497,000 stock options. These shares have a vesting term ofthree years, an expiration date often years from the grant date, and were valued at approximately $0.6 million as of the grant date.
The stock options granted during thesix months were valued utilizing the Black-Scholes options pricing model with the following inputs: $1.78-2.94 of stock price,3.91%-4.31% risk-free rate,127%-126.76% volatility,0% dividend rate, and the expected term of 3 years.
26
The following table summarizes the Company’s employee and non-employee stock option activity under the2021 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 |
| Options granted | — | — | — | — |
| Forfeited/Expire | (143,150) | — | — | — |
| Outstanding as of December 31, 2024 | 121,833 | 22.36 | 7.0 | — |
| Options granted | 547,000 | 1.84 | 10.0 | |
| Forfeited/Expire | (5,380) | — | — | — |
| Outstanding as of June 30, 2025 | 663,453 | 5.54 | 9.3 | — |
| Options vested and exercisable as of June 30, 2025 | 119,281 | $22.52 | 6.6 | $— |
Stock-based compensation expense related to stock options was less than $0.1 million and $0.1 million for thethree months ended* June 30, 2025and2024,* respectively. Stock-based compensation expense related to stock options was less than $0.1 million and approximately $0.3 million for thesix months ended* June 30, 2025and2024,* respectively.
At* June 30, 2025,*the total unrecognized compensation related to unvested employee and non-employee stock option awards granted was $0.7 million, which the Company expects to recognize over a weighted-average period of approximately 2.96 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 |
| Granted | — | |
| Vested | (90,833) | $4.64 |
| Forfeited | (33,333) | $5.20 |
| Balance as of December 31, 2024 (unvested) | — | — |
| Granted | — | $— |
| Vested | — | $— |
| Forfeited | — | $— |
| Balance as of June 30, 2025 (unvested) | — | — |
On* July 12, 2022,the Board granted an award of 100,000 restricted shares of the Company (“Restricted Stock”) as an inducement to the newly appointed CEO, pursuant to a separate Restricted Stock Award Agreement (the “RSA”). The Restricted Stock vested in approximately equal installments overthree* (3) years from the grant date, subject to continued service through the applicable vesting date.
On* December 28, 2023,*the Company granted 57,500 RSAs to a consultant for services provided. The RSAs vested aftersix months from the grant date. 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.
27
Stock-based compensation expense related to RSAs was $0 and less than $0.1 million for thethree months ended* June 30, 2025and2024,* respectively. Stock-based compensation expense related to RSAs was $0 and less than $0.1 million for thesix months ended* June 30, 2025and2024,* respectively.
In* October 2024,the Company's CEO announced his resignation and as a result, all unvested RSAs were forfeited. Accordingly, the Company doesnot expect to recognize any further stock-based compensation expense for the balance of unvested RSAs as of December 31, 2024.*
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, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| (Unaudited) | ||||
| Stock-based compensation expense | ||||
| General and administrative | $55 | $72 | $67 | $283 |
| Research and development | 12 | 25 | 12 | 56 |
| Total stock-based compensation expense | $67 | $97 | $79 | $339 |
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 thethree andsix months ended* June 30, 2025and2024.* 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, and warrants issued with the Convertible Notes are estimated based on the Black-Scholes model. The fair value of the convertible notes payable was estimated utilizing a Monte Carlo simulation.
Fair Value on a Recurring Basis
The Company follows the guidance in ASC820 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 Level1 measurement. The estimated fair value of the warrant liabilities and convertible note payable represent Level3 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, 2025and December 31, 2024,*and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value (in thousands):
| Description | Level | June 30, 2025 | December 31, 2024 |
|---|---|---|---|
| (Unaudited) | |||
| Assets: | |||
| Money Market Account | 1 | $243 | $487 |
| Liabilities: | |||
| Warrant liabilities (Note 9) | 3 | $16,266 | $5,639 |
| Convertible note payable and accrued interest (Note 7) | 3 | $9,854 | $6,257 |
28
Convertible Note Payable - Anson
The significant inputs used in the Monte Carlo simulation to measure the Anson note liability that is categorized within Level3 of the fair value hierarchy are as follows:
| June 30, | |||
|---|---|---|---|
| Stock price on valuation date | $3.26 | ||
| Time to expiration | 0.54 | – | 0.83 |
| Cost of debt | 12.66% | ||
| Equity volatility | 117.5% | – | 138.0% |
| Risk-free rate | 4.07% | ||
| Probability of credit default prior to maturity | 0% | ||
The following table sets forth a summary of the changes in the fair value of the Anson Note categorized within Level3 of the fair value hierarchy (in thousands):
| Fair value of Anson Notes as of December 31, 2024 | $6,257 |
|---|---|
| Fair value of Anson III Note at issuance | 2,522 |
| Conversion and repayments of principal and interest (shares) | (1,347) |
| Fair value adjustment through earnings | 965 |
| Fair value of Anson Notes as of March 31, 2025 | 8,397 |
| Conversion and repayments of principal and interest (shares) | (4,108) |
| Fair value adjustment through earnings | 5,565 |
| Fair value of Anson Notes as of June 30, 2025 | $9,854 |
| Convertible note payable - current portion as of June 30, 2025 | $9,854 |
| Convertible note payable, net of current portion as of June 30, 2025 | $— |
29
Warrant Liabilities
The Company utilizes a Black-Scholes model approach to value its liability-classified warrants at each reporting period, with changes in fair value recognized in the condensed consolidated statements of operations. The estimated fair value of the warrant liabilities is determined using Level3 inputs. There wereno 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. Treasuryzero-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 weighted-average significant inputs used in the Black-Scholes model to measure the warrant liabilities that are categorized within Level3 of the fair value hierarchy are as follows:
| June 30, 2025 · December 31, 2024 | |||||
|---|---|---|---|---|---|
| Stock price on valuation date | $3.26 | $2.20 | |||
| Exercise price per share | $1.77 | – | 11.50 | $2.08 | |
| Expected life | 0.90 | – | 4.58 | 4.69 | |
| Volatility | 123.50% | – | 162.1% | 111% | |
| Risk-free rate | 3.77% | – | 4.10% | 4.37% | |
| Dividend yield | 0.00% | 0.0% | |||
| Fair value of warrants | $0.09 | – | 3.24 | $1.76 | |
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, 2024 | $5,639 |
|---|---|
| Initial recognition of issuance of warrants | 7,109 |
| Change in fair value of warrant liabilities | (2,896) |
| Balance as of March 31, 2025 | $9,852 |
| Change in fair value of warrant liabilities | 6,414 |
| Balance as of June 30, 2025 | $16,266 |
12. Segment Reporting
The Company operates as asingle operating and reportable segment, consistent with the manner in which the Chief Executive Officer, designated as the Chief Operating Decision Maker (“CODM”) of the Company, evaluates the Company’s performance and allocates resources. The Company’s operations solely consist of the development of novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, and post-traumatic stress disorder (“PTSD”) and now schizophrenia.
The Company didnot generate any revenue during thesix months ended* June 30, 2025or the year ended December 31, 2024.*The CODM evaluates performance based on operating expenses and monitors key expense categories related to the Company’s research and development activities, as well as general and administrative functions. As the Company is currently in the pre-revenue phase, the associated expenses above are drivers.
30
The CODM doesnot separately evaluate performance by geographic region or product line, as the Company hasnot yet commenced commercial operations and has limited operations due to the current liquidity and funding of the Company. The Company’s operations are conducted solely within the United States of America.
Significant Segment Information
All of the Company’s assets relate to this single operating segment, see the accompanying balance sheets.
All of the Company’s operating expenses, which consists of research and development and general and administrative expenses, relate to this single operating segment, see the accompanying statements of operations.
The following table reconciles the loss from operations to total loss:
| For the three months ended June 30, | For the six months ended June 30, | |||
|---|---|---|---|---|
| Expense Category | 2025 | 2024 | 2025 | 2024 |
| Loss from operations | $(3,730) | $(7,050) | $(7,577) | $(13,048) |
| Interest income | (2) | (7) | (6) | (34) |
| Interest expense | - | - | - | 230 |
| Change in fair value of convertible notes payable | 5,565 | 23 | 6,530 | 341 |
| Change in fair value of warrant liabilities | 6,414 | (18) | 3,518 | (9) |
| Loss on issuance of the Registered Direct Offering | - | - | 729 | - |
| convertible note default penalties | - | 849 | - | 849 |
| Loss on Considerations Shares and Warrants | - | - | 1,277 | - |
| Loss on convertible note conversions | 1,874 | - | 3,467 | - |
| Net loss | $(17,581) | $(7,897) | $(23,092) | $(14,425) |
Long-lived assets consist of property, plant, and equipment, net which are included in other assets in the balance sheet as they arenot material. Long-lived assets by year are as follows:
| June 30, 2025 | December 31, 2024 | |
|---|---|---|
| Computers, cost | $29 | $29 |
| Accumulated depreciation | (21) | (19) |
| Total equipment | $8 | $10 |
13. Income Taxes
The Company recordedno provision or benefit for income tax expense for thesix months ended* June 30, 2025and2024,* respectively.
For all periods presented, the pretax losses incurred by the Company receivedno corresponding tax benefit because the Company concluded that it is more likely thannot 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.
14. 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 thethree months ended* June 30, 2025and2024,* the Company paid Glytech $0.0 million and $0.1 million, respectively, for continuing technology support services and reimbursed expenses. During thesix months ended* June 30, 2025and2024,* the Company paid Glytech $0.0 million and $0.1 million, respectively, for continuing technology support services and reimbursed expenses. These support services are ongoing.
31
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 donot 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, 2022the Glytech Agreement was amended whereby Glytech agreed to transfer and assign the remainder of the Licensed Technology and the Excluded Technology to the Company forno* additional consideration at any time upon receipt of written notice from the Company if, on or prior to* June 30, 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 fortwenty* (20) consecutive trading days immediately preceding any given date and (ii) there areno 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 followingtwenty trading days).
Consulting Agreement with Dr. Jonathan Javitt
The Chief Scientist of the Company, Dr. Jonathan Javitt, is a major shareholder in the Company and a member of the Board of Directors. Therefore, his services are deemed to be a related party transaction. He served the Company on a full-time basis as CEO under an employment agreement with the Company until* March 8, 2022and currently serves under a Consulting Agreement with the Company as Chief Scientist thereafter and received compensation of $0.3 million and $0.2 million during thethree* months ended* June 30, 2025and2024,* respectively, and received compensation of $0.6 million and $0.4 million during thesix months ended* June 30, 2025and2024,* respectively.
On* March 29, 2023,the Consulting Agreement dated March 8, 2022 (the “Javitt Consulting Agreement”) between the Company and Dr. Jonathan Javitt was amended to extend the term of the Agreement until March 8, 2024with automatic annual renewals thereafter unlessone* party or the other provides notice of non-renewal. The 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 for2023, if any,* maybe approved by the board in2024* 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. The annual discretionary bonus for2024,* if any,* maybe approved by the board in2025* and is payable in* March 2025,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, 2025and December 31, 2024,*the annual discretionary bonus of $0.2 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’s2021 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, 2025,the Board of Directors hasnot* 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 and less than $0.1 million during thethree months ended* June 30, 2025and2024,* respectively. The Company paid this family member a total of $0.1 million and less than $0.1 million during thesix months ended* June 30, 2025and2024,* respectively. These services are ongoing.
Included in accounts payable were $0.2 million and less than $0.1 million due to the above related parties as of* June 30, 2025and December 31, 2024,*respectively.
15. Subsequent Events
From* July 9, 2025through August 14, 2025,*the Company sold an aggregate of 231,489 shares of its common stock shares for approximately $0.7 million, net of less than $0.02 million in offering costs.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.