What changed in this filing

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Item 1. Financial Statements

2025-08-18 compared with 2025-05-15 · 439 added, 312 removed, 915 unchanged (45% of the section changed)

27 unchanged sentences

Series A convertible preferred stock, $ 0.001 par value, 12,000,000 shares authorized;

0 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively

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;

17,120,120 and 14,591,505 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively

19,473,588 and 14,591,505 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively

Additional paid-in capital

10 unchanged sentences

(in thousands, except share and per share data)

Three months ended March 31,

Three months ended

Six months ended June

Operating expense:

2 unchanged sentences

General and administrative

2,743 4,246 5,686 8,496

Settlement expense

Total operating expenses

3,730 7,050 7,577 13,048

Loss from operations

( 3,730 ) ( 7,050 ) ( 7,577 ) ( 13,048 )

Other expense (income):

Other (income) expense:

Interest income

( 2 ) ( 7 ) ( 6 ) ( 34 )

Interest expense

Change in fair value of convertible notes payable

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

Loss on issuance of the Registered Direct Offering (see Note 9)

Loss on Consideration Shares and Warrants (see Note 9)

Loss on convertible note redemptions

Loss on convertible note conversions

1,874 — 3,467 —

Total other expenses, net

13,851 847 15,515 1,377

$ ( 17,581 ) $ ( 7,897 ) $ ( 23,092 ) $ ( 14,425 )

Net loss per share:

8 unchanged sentences

(in thousands, except share data)

Series A Preferred

Comprehensive

8 unchanged sentences

— — — — ( 3,255 ) — — ( 3,255 )

Amortization of prepaid offering costs — — — — ( 7 ) — — ( 7 )

Amortization of deferred offering costs

— — — — ( 7 ) — — ( 7 )

Consideration Shares issued as a result of repricing (See Note 9)

5 unchanged sentences

— $ — 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

— — — — — ( 17,581 ) — ( 17,581 )

Balance – June 30, 2025

— $ — 19,473,588 $ 19 $ 265,732 $ ( 301,366 ) $ — $ ( 35,615 )

Series A Preferred

7 unchanged sentences

( 3,000,000 ) ( 3 ) 300,000 — 3 — — —

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

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

— — 34,584 — 179 — — 179

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

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 common stock shares to be issued)

Common stock and warrants issued in private placement

— — 270,000 — 1,027 — — 1,027

8 unchanged sentences

— $ — 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

— — — — — ( 7,897 ) — ( 7,897 )

Balance - June 30, 2024

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

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

2 unchanged sentences

(in thousands)

Three months ended March 31,

Six months ended June 30,

CASH FLOWS FROM OPERATING ACTIVITIES:

$ ( 5,512 ) $ ( 6,528 )

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

1 unchanged sentence

Stock-based compensation

Common stock issued in exchange for services

Change in fair value of warrant liabilities

Change in fair value of convertible notes payable

Change in fair value of convertible promissory note

Loss on Consideration Shares and Warrants

Loss on issuance of Registered Direct Offering

Loss on convertible notes redemptions

Loss on convertible notes conversion

Expense for debt issuance costs due to fair value election on Anson Notes

Warrant issuance costs related to Alvogen termination

Convertible note default penalty

Changes in operating assets and liabilities:

1 unchanged sentence

Accounts payable

Insurance loan payable

Accrued expense and other liabilities

( 337 ) ( 54 )

Net cash used in operating activities

( 3,480 ) ( 3,671 )

CASH FLOWS FROM INVESTING ACTIVITIES

Purchase of computer equipment

Net cash used in investing activities

CASH FLOWS FROM FINANCING ACTIVITIES

2 unchanged sentences

Expense for debt issuance costs due to fair value election on Anson Notes

Proceeds from issuance of insurance loan

Proceeds from Anson convertible notes, net of OID

Proceeds from issuance of common stock and warrants issued in Registered Direct offering, net of issuance costs

Proceeds from ATM offering, net of offering costs

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

2 unchanged sentences

Net increase (decrease) in cash and cash equivalents

4,105 ( 3,276 )

Cash and cash equivalents at beginning of period

Cash and cash equivalents at end of period

$ 5,548 $ 1,319

Supplemental disclosure of cash flow information:

2 unchanged sentences

Non-cash investing and financing activities

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

$ 1,347 $ 400

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

Issuance of common stock warrants as offering costs

Conversion of Series A preferred stock into common stock

Warrants issued pursuant to the Alvogen Agreement amendment

Amortization of deferred offering costs to additional paid-in-capital

2 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2025

JUNE 30, 2025

NRx Pharmaceuticals, Inc.

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 now schizophrenia.

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 has two lead drug candidates that are expected to be submitted during the second quarter of 2025 for Food and Drug Administration (“ FDA ”) approval with anticipated FDA decision dates under the Prescription Drug User Fee Act (" PDUFA ") by year end 2025:

NRX- 101, an oral fixed dose combination of D-cycloserine and lurasidone and NRX- 100, a preservative-free formulation of ketamine for intravenous infusion.

The Company has two 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:

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.

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.

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 interventional psychiatric treatment of the above conditions with NMDA-targeted and other psychedelic drugs, neuromodulatory devices, such as Transcranial Magnetic Stimulation (“TMS”), digital therapeutics, and medication management.

(“ 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.

Fiscal 2024 and the first quarter of 2025 marked a period of both expansion and change for NRx.

Throughout this time, the Company implemented a restructuring of its leadership to address challenges related to capital formation, clinical trial enrollment, and corporate development.

These efforts led to measurable achievements throughout 2024 and the first quarter of 2025, and positioned the Company for growth and the achievement of our development objectives in 2025.

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 NRx, while also treating patients through HOPE.

During the second quarter of 2025 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:

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 d efinitive 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.

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 March 31, 2025.

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 has no revenues and expects to continue to incur operating losses at least through the remainder of 2025.

1 unchanged sentence

In the absence of these projected developments, the Company’s ability to support its ongoing capital needs is dependent on its ability to continue to raise equity and/or debt financing, which may not be available on favorable terms, or at all, in order to continue operations.

As of March 31, 2025, the Company had $ 5.5 million in cash and cash equivalents.

On August 12, 2024, the Company entered into that certain Securities Purchase Agreement dated August 12, 2024 ( the “ Purchase Agreement ”) with certain accredited investors (the “ Investors ”), pursuant to which the Company agreed to sell Senior Secured Convertible Promissory Notes (the “ Anson Notes ”) in the aggregate principal amount of up to approximately $ 16.3 million in three tranches of $ 5.4 million, and warrants to purchase that amount of shares of the Company’s common stock, $ 0.001 par value (“ Common Stock ”) equal to 50% of the principal amount of the Notes in the respective tranche divided by the volume weighted average price (“ 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 Purchase Agreement (the “ Anson Warrants ”).

The Company consummated the sale of the first tranche of $ 5.4 million ($ 4.5 million in net proceeds) in Notes and Warrants (the “ First Closing ”) on August 14, 2024 ( the “ First Closing Date ”), the second tranche of $ 5.4 million in Notes and Warrants (the “ Second Closing ”) on October 10, 2024 ( the “ Second Closing Date ”), and the third tranche of $ 5.4 million in Notes and Warrants (the “ Third Closing ”) on January 28, 2025 ( the “ Third Closing Date ”) for aggregate gross proceeds of approximately $ 15.0 million, after deducting the original issue discount, but before deducting fees, costs, and other expenses including the use of proceeds to repay $ 5.6 million owed to Streeterville Capital, LLC, a Utah limited liability company (“ Streeterville ”) pursuant to a 9 % redeemable promissory note (as amended, the “ Streeterville Note ”) issued to Streeterville.

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, 2025 resulting in net proceeds to the Company of approximately $ 3.255 million after offering costs.

The RD Warrants are exercisable for five 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 Note 7 and 9 ).

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 the three and six months ended June 30, 2025 the 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 Note 9, “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.

15 unchanged sentences

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, and the utilization of deferred tax assets.

These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.

18 unchanged sentences

Deposits in financial institutions may, from time to time, exceed federally insured limits.

As of March 31, 2025 the Company’s cash and cash equivalents balance within money market accounts was in excess of the U.S.

As of June 30, 2025 the 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.

62 unchanged sentences

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 promissory notes are expensed as incurred.

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.

18 unchanged sentences

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 (as defined below) using a Black Scholes valuation methodology.

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.

23 unchanged sentences

The following outstanding shares of Common Stock equivalents were excluded from the computation of the diluted net loss per share attributable to Common Stock for the periods in which a net loss is presented because their effect would have been anti-dilutive.

Three months ended March 31,

Six months ended June 30,

Stock options

3 unchanged sentences

9,536,222 4,069,240

Common shares issuable upon conversion of Anson Notes

Recent Accounting Pronouncements Not Yet Adopted

37 unchanged sentences

Following the termination of the License Agreement by Alvogen, the amounts advanced pursuant to the amendment became due and payable to Alvogen.

Accordingly, the refund liability has not been reclassified to deferred revenue or recorded as revenue as of March 31, 2025 and will remain permanent as refund liability until settled.

Accordingly, the refund liability has not 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 March 31, 2025, the refund liability due to Alvogen was $ 4.7 million, which represents all payments made by Alvogen through March 31, 2025, and is included as a component of accrued expense and other current liabilities on the condensed consolidated balance sheet (refer to Note 5 ).

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 Note 5 ).

Following the early termination by Alvogen, the Company does not anticipate recognizing any revenue under the License Agreement.

11 unchanged sentences

The modifications did not result in recognition of a gain or loss in the condensed consolidated statements of operations as the modifications were not considered debt extinguishments, but will impact interest expense and the determination of fair value in future periods.

As of March 31, 2025 and December 31, 2024, the Note carried a remaining principle balance of $ 0 million.

As of June 30, 2025 and December 31, 2024, the Note carried a remaining principle balance of $ 0 million.

Refer to Note 11 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 Investors.

On August 12, 2024, the Company entered into the Purchase Agreement with the Investors.

The Company agreed to sell, in three 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.

37 unchanged sentences

Refer to Note 11 for the reconciliation of the fair values for the periods presented.

During the three months ended March 31, 2025, Anson converted $ 1.3 million of principal and interest of the First Tranche Note into common stock, resulting in the issuances of 1,004,055 shares of Common Stock and loss on redemption of $ 1.6 million.

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 and loss on redemption of less than $0.1 million.

During the three 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 the three month ended June 30, 2025 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 and loss on conversion of $ 1.9 million.

(see Note 9 ).

As of March 31, 2025, the principal and accrued interest balance of the Anson Notes was $ 10.86 million and $ 0.2 million, respectively.

During the three months ended March 31, 2025 , the Company recorded a loss from the change in fair value of the Second and Third Tranche Notes of $ 1 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 March 31, 2025, the effective interest rates of the Second and Third Tranche Note was 5 % and 85 %, respectively.

The following table presents the Anson Notes as of March 31, 2025 ( in thousands):

March 31, 2025

Par value of the Anson Notes

Initial original issue discount

Conversions and repayments of principal and interest (shares)

Carrying value of the Anson Notes before current period change in fair value

Fair value allocated to Common Stock liability classified warrants

Fair value adjustment through earnings

Total carrying value of Anson Notes

Convertible note payable - current portion

Convertible note payable, net of current portion

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 the three and six 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 Note 11, “Fair Value Measurements,” for a summary of activity for the Anson Notes.

Commitments and Contingencies

9 unchanged sentences

The milestone payments due above may be reduced by 25 % in certain circumstances, and by the application of certain sub-license fees.

As of March 31, 2025, the total cumulative payments made under the SHMH License Agreement were $ 0.4 million, with no payments made during the three months ended March 31, 2025 and 2024.

As of June 30, 2025, the total cumulative payments made under the SHMH License Agreement were $ 0.5 million, with $ 0.2 million in payments made during the three and six months ended June 30, 2025.

There were no payments made during the three and six months ended June 30, 2024.

A royalty in an amount equal to:

3 unchanged sentences

Royalties shall also apply to any revenues generated by sub-licensees from sale of Licensed Products subject to a cap of 8.5 % of the payments received by us from sub-licensees in connection with such sales.

During the three months ended March 31, 2025 and 2024, no royalty payments were made.

During the three and six months ended June 30, 2025 and 2024, no royalty payments were made.

Annual Maintenance Fee

A fixed amount of $ 100,000 was paid on April 16, 2021 and, thereafter, a fixed amount of $ 150,000 is due on the anniversary of such date during the term of the SHMH License Agreement.

As of March 31, 2025, the Company has recorded no expenses relating to the annual maintenance fee of the Agreement.

During the three and six months ended June 30, 2025 and 2024, the company recorded $ 150,000 and $ 0 in related annual maintenance fee, respectively.

Exclusive License Agreement

1 unchanged sentence

The patent is supported by extensive nonclinical data and early clinical data that suggest the potential for NMDA antagonist drugs, such as NRX- 101 to decrease both chronic pain and neuropathic pain while potentially decreasing craving for opioids.

For the three months ended March 31, 2025 and 2024, the Company has recorded no expenses relating to the licensure of the patent.

For the three and six months ended June 30, 2025 and 2024, the Company has recorded no 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 acquire 100% 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 and third -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 and third -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.

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 does not 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 Exhibit 10.6 of the Company’s Quarterly Report on Form 10 -Q as of March 31, 2025.

The Kadima Purchase Agreement was previously attached to provide investors with information regarding its terms.

It is not 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 should not 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 have not 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 the three months ended March 31, 2025 and 2024 was less than $ 0.1 million and $ 0.1 million, respectively.

The rent expense for the three and six months ended June 30, 2025 and 2024 was less than $ 0.1 million and $ 0.1 million, respectively.

Legal Proceedings

The Company is currently involved in and may from time to time become involved in various legal actions incidental to our business.

As of the date of this report, the Company is not involved in any legal proceedings that it believes could have a material adverse effect on its financial position or results of operations.

However, the outcome of any current or future legal proceeding is inherently difficult to predict and any dispute resolved unfavorably could have a material adverse effect on the Company’s business, financial position, and operating results.

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 has not, 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 are no 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 have not closed the Acquisition, and, while no 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.

Preferred Stock

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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 March 31, 2025, no shares of Series A Preferred remained issued or outstanding.

As of June 30, 2025, no shares of Series A Preferred remained issued or outstanding.

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 .

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Wainwright & Co., and filed a prospectus supplement (the “ Current Prospectus Supplement ”) under the Offering Agreement for an aggregate of $ 4.9 million.

Through March 31, 2025, the aggregate net cash proceeds to the Company from the ATM Purchases Agreements were approximately $ 1.6 million.

The Company suspended the At the Market Offering from August 14, 2024 through 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 the six and three months ended June 30, 2025 the Company sold an aggregate of 399,078 of its common stock shares for approximately $1.04 million, net of $ 0.03 million in offered costs.

On February 27, 2024, the Company entered into an underwriting agreement (the “ February Underwriting Agreement ”) with EF Hutton LLC (the “ Representative ”), as the representative of the several underwriters named therein (the “ February Underwriters ”), relating to an underwritten public offering (the “ February 2024 Public Offering ”) of 500,000 shares (the “ February Shares ”) of the Company’s Common Stock.

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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 redemption of $ 1.3 million (see Note 7 ).

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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 March 31, 2025.

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 their first conversion notice for Notes issued in the Second or Third Closing.

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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 March 31, 2025, the obligation under this provision has been fully satisfied.

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.

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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 the period ended March 31, 2025.

During the three months ending March 31, 2025, 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 redemption of $ 1.6 million (See Note 7 ).

During the three months ending March 31, 2025, 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 redemption of less than $ 0.1 million (See Note 7 ).

During the first quarter of fiscal 2025, 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 Note 7 ).

During the first quarter of fiscal 2025, 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 Note 7 ).

During the second quarter of fiscal 2025, 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 Note 7 ).

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The Consideration Warrants, liability-classified under ASC 815 - 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 the period ended March 31, 2025, within accompanying condensed consolidated statements of operations and comprehensive loss.

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 the six 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 the three and six month ended June 30, 2025.

Common Stock Warrants

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The Public Warrants became exercisable at the effective time of the Merger and expire five years after the effective time on or earlier upon their redemption or liquidation of the Company.

During the three months ended March 31, 2025 and 2024 no Public Warrants were exercised.

During the three and six months ended June 30, 2025 and 2024 no Public Warrants were exercised.

The outstanding balance of these public warrants remains in equity.

At March 31, 2025 and December 31, 2024, there were 3,448,856 Public Warrants outstanding to purchase up to 344,886 shares of Common Stock.

At June 30, 2025 and 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

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The Private Placement Warrants are not indexed to the Company’s common shares in the manner contemplated by FASB ASC Topic 815 - 40 - 15 because the holder of the instrument is not an input into the pricing of a fixed-for-fixed option on equity shares.

The Company classifies the Private Placement Warrants as derivative liabilities in its condensed consolidated balance sheets as of March 31, 2025 and December 31, 2024.

The Company classifies the Private Placement Warrants as derivative liabilities in its condensed consolidated balance sheets as of June 30, 2025 and 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 the three months ended March 31, 2025 and 2024.

The Company recognized a gain on the change in fair value of the Private Placement Warrants for the three and six months ended June 30, 2025 and 2024.

Refer to Note 11 for discussion of the fair value measurement of the Company’s warrant liabilities.

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The grant date fair value of these RD Warrants was estimated to be $ 3.983 million on January 29, 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.

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The grant date fair value of these Consideration Warrants was estimated to be $ 0.6 million on March 20, 2025.

As of March 31, 2025, the fair value of the Anson Warrants was $ 9.9 million.

The Company recognized a gain on the change in fair value of The Anson Warrant for the three months ended March 31, 2025 of approximately $ 2.9 million.

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 the three and six months ended June 30, 2025 of approximately $ 6.4 million and $ 3.5 million, respectively.

Refer to Note 11 for discussion of the fair value measurement of the Company’s warrant liabilities.

The following table provides the activity for all warrants for the respective periods.

Weighted Weighted

Average Average

Outstanding as of December 31, 2023

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2,381,796 5.00 2.86 —

Outstanding as of March 31, 2025

( 19,340 ) — — —

Outstanding as of June 30, 2025

9,536,222 3.61 $ 8.52 $ 530

Stock-Based Compensation

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2021 Omnibus Incentive Plan

As of March 31, 2025, 1,050,809 shares of Common Stock are authorized for issuance pursuant to awards under the Company’s 2021 Omnibus Incentive Plan (the “ 2021 Plan ”).

As of June 30, 2025, 1,050,809 shares of Common Stock are authorized for issuance pursuant to awards under the Company’s 2021 Omnibus Incentive Plan (the “ 2021 Plan ”).

As of January 1, 2025, 95,528 shares were added to the 2021 Plan under an evergreen feature that automatically increases the reserve with additional shares of Common Stock for future issuance under the Incentive Plan each calendar year, beginning January 1, 2022 and ending on and including January 1, 2031, equal to the lesser of (A) 1 % of the shares of Common Stock outstanding on the final day of the immediately preceding calendar year or (B) a smaller number of shares determined by the Board.

On December 28, 2023, the first amendment to the 2021 Omnibus Plan was executed which increased the maximum number of shares (i) available for issuance under the Plan by an additional 200,000 shares, and (ii) that may be delivered pursuant to the exercise of Incentive Stock Options granted under the Plan to be equal to 100% of the Share Pool.

As of March 31, 2025, an aggregate 620,099 shares have been awarded net of forfeitures, and 430,710 shares remain available for issuance under the 2021 Plan.

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 the 2021 Plan.

The 2021 Plan permits the granting of incentive stock options, restricted stock awards, other stock-based awards or other cash-based awards to employees, directors, and non-employee consultants.

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Additionally, certain options granted contain terms that require all unvested options to immediately vest a) upon the approval of an NDA by the FDA for NRX‑101, or b) immediately preceding a change in control of the Company, whichever occurs first.

The Company issued 50,000 stock options during the three or three months ended March 31, 2025.

On February 7, 2025, the Company issued 50,000 stock options.

These shares have a vesting term of three years, an expiration date of ten 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 of three years, an expiration date of ten years from the grant date, and were valued at approximately $ 0.6 million as of the grant date.

The stock options granted during the six 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.

The following table summarizes the Company’s employee and non-employee stock option activity under the 2021 Plan for the following periods:

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( 5,380 ) — — —

Outstanding as of March 31, 2025

Outstanding as of June 30, 2025

663,453 5.54 9.3 —

Options vested and exercisable as of March 31, 2025

Options vested and exercisable as of June 30, 2025

119,281 $ 22.52 6.6 $ —

Stock-based compensation expense related to stock options was $ 0.1 million and $ 0.4 million for the three months ended March 31, 2025 and 2024, respectively.

At March 31, 2025, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted, was $ 0.1 million, which the Company expects to recognize over a weighted-average period of approximately 2.71 years.

Stock-based compensation expense related to stock options was less than $ 0.1 million and $ 0.1 million for the three months ended June 30, 2025 and 2024, respectively.

Stock-based compensation expense related to stock options was less than $ 0.1 million and approximately $ 0.3 million for the six months ended June 30, 2025 and 2024, 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

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Balance as of December 31, 2024 (unvested)

Balance as of March 31, 2025 (unvested)

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 will vest in approximately equal installments over three ( 3 ) years from the grant date, subject to continued service through the applicable vesting date.

The Restricted Stock vested in approximately equal installments over three ( 3 ) years from the grant date, subject to continued service through the applicable vesting date.

On December 28, 2023, the Company granted 57,500 RSAs to a consultant for services provided.

The RSAs will vest after six 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 will be amortized over the vesting term.

Stock-based compensation expense related to RSAs was $ 0.0 million and $ 0.2 million for the three months ended March 31, 2025 and 2024, respectively.

The RSAs vested after six 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.

Stock-based compensation expense related to RSAs was $ 0 and less than $ 0.1 million for the three months ended June 30, 2025 and 2024, respectively.

Stock-based compensation expense related to RSAs was $ 0 and less than $ 0.1 million for the six months ended June 30, 2025 and 2024, respectively.

In October 2024, the Company's CEO announced his resignation and as a result, all unvested RSAs were forfeited.

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Three months ended

Six months ended

Stock-based compensation expense

General and administrative

$ 55 $ 72 $ 67 $ 283

Research and development

Total stock-based compensation expense

$ 67 $ 97 $ 79 $ 339

Fair Value Measurements

Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the three months ended March 31, 2025 and 2024.

Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the three and six months ended June 30, 2025 and 2024.

The carrying amount of accounts payable approximated fair value as they are short term in nature.

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The estimated fair value of the warrant liabilities and convertible note payable represent Level 3 measurements.

The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis at March 31, 2025 and December 31, 2024, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value (in thousands):

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, 2025 and December 31, 2024, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value (in thousands):

Money Market Account

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3 $ 16,266 $ 5,639

Convertible note payable (Note 7)

Convertible note payable and accrued interest (Note 7)

3 $ 9,854 $ 6,257

Convertible Note Payable - Streeterville

The significant inputs used in the Monte Carlo simulation to measure the Streeterville note liability that is categorized within Level 3 of the fair value hierarchy are as follows:

Stock price on valuation date

Time to expiration

Note market interest rate

Equity volatility

Volume volatility

Risk-free rate

Probability of default

During the year ended December 31, 2024, the Streeterville Note was repaid in full and the outstanding balance was $ 0 as of December 31, 2024.

The following table sets forth a summary of the changes in the fair value of the Streeterville Note categorized within Level 3 of the fair value hierarchy (in thousands):

Fair value of the Note as of December 31, 2023

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

Fair value adjustment through earnings

Fair value adjustment through accumulated other comprehensive loss

Fair value of the Note as of March 31, 2024

Convertible note payable - current portion

Convertible note payable, net of current portion

Convertible Note Payable - Anson

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Fair value of Anson Notes as of March 31, 2025

Convertible note payable - current portion

Convertible note payable, net of current portion

Conversion and repayments of principal and interest (shares)

Fair value adjustment through earnings

Fair value of Anson Notes as of June 30, 2025

Convertible note payable - current portion as of June 30, 2025

Convertible note payable, net of current portion as of June 30, 2025

Warrant Liabilities

10 unchanged sentences

Stock price on valuation date

$ 2.05 $ 4.70

Exercise price per share

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Dividend yield

0.00 % 0.00 %

Fair value of warrants

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Balance as of March 31, 2024

Gain upon re-measurement

Balance as of June 30, 2024

Balance as of December 31, 2024

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Balance as of March 31, 2025

Change in fair value of warrant liabilities

Balance as of June 30, 2025

Segment Reporting

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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 did not generate any revenue during the three months ended March 31, 2025 or the year ended December 31, 2024.

The Company did not generate any revenue during the six months ended June 30, 2025 or 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.

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The following table reconciles the loss from operations to total loss:

For the three months ended

For the three months

For the six months

Expense Category

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Interest income

( 2 ) ( 7 ) ( 6 ) ( 34 )

Interest expense

Change in fair value of convertible notes payable

5,565 23 6,530 341

Change in fair value of warrant liabilities

Loss on issuance of Registered Direct Offering common shares

Loss on convertible note redemptions

6,414 ( 18 ) 3,518 ( 9 )

Loss on issuance of the Registered Direct Offering

c onvertible note default penalties

Loss on Considerations Shares and Warrants - - 1,277 -

Loss on convertible note conversions

1,874 - 3,467 -

$ ( 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 are not material.

Long-lived assets by year are as follows:

March 31, 2025

June 30, 2025

December 31, 2024

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Total equipment

The Company recorded no provision or benefit for income tax expense for the three months ended March 31, 2025 and 2024, respectively.

The Company recorded no provision or benefit for income tax expense for the six months ended June 30, 2025 and 2024, respectively.

For all periods presented, the pretax losses incurred by the Company received no corresponding tax benefit because the Company concluded that it is more likely than not that the Company will be unable to realize the value of any resulting deferred tax assets.

The Company will continue to assess its position in future periods to determine if it is appropriate to reduce a portion of its valuation allowance in the future.

The Company has no open tax audits with any taxing authority as of March 31, 2025.

Related Party Transactions

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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 the three months ended March 31, 2025 and 2024, the Company paid Glytech $ 0.1 million and $ 0.1 million, respectively, for continuing technology support services and reimbursed expenses.

During the three months ended June 30, 2025 and 2024, the Company paid Glytech $ 0.0 million and $ 0.1 million, respectively, for continuing technology support services and reimbursed expenses.

During the six months ended June 30, 2025 and 2024, 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.

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This definition would cover pharmaceutical formulations, including some that the Company considers “pipeline” or “future product” opportunities, that contain a combination of pharmaceutical components different from those contained in NRX- 100 and NRX- 101.

On November 6, 2022 the Glytech Agreement was amended whereby Glytech agreed to transfer and assign the remainder of the Licensed Technology and the Excluded Technology to the Company for no additional consideration at any time upon receipt of written notice from the Company if, on or prior to March 31, 2024, ( i) the value of the Glytech equity holdings in the Company (the “ Glytech Equity ”) has an aggregate liquidity value of at least $ 50 million for twenty ( 20 ) consecutive trading days immediately preceding any given date and (ii) there are no legal or contractual restrictions on selling all of the securities represented by the Glytech Equity then applicable to Glytech (or reasonably foreseeable to be applicable to Glytech within the following twenty trading days).

On November 6, 2022 the Glytech Agreement was amended whereby Glytech agreed to transfer and assign the remainder of the Licensed Technology and the Excluded Technology to the Company for no additional consideration at any time upon receipt of written notice from the Company if, on or prior to 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 for twenty ( 20 ) consecutive trading days immediately preceding any given date and (ii) there are no legal or contractual restrictions on selling all of the securities represented by the Glytech Equity then applicable to Glytech (or reasonably foreseeable to be applicable to Glytech within the following twenty trading days).

Consulting Agreement with Dr.

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Therefore, his services are deemed to be a related party transaction.

He served the Company on a full-time basis as CEO under an employment agreement with the Company until March 8, 2022 and currently serves under a Consulting Agreement with the Company as Chief Scientist thereafter and received compensation of $ 0.1 million and $ 0.2 million during the three months ended March 31, 2025 and 2024, respectively.

He served the Company on a full-time basis as CEO under an employment agreement with the Company until March 8, 2022 and currently serves under a Consulting Agreement with the Company as Chief Scientist thereafter and received compensation of $ 0.3 million and $ 0.2 million during the three months ended June 30, 2025 and 2024, respectively, and received compensation of $ 0.6 million and $ 0.4 million during the six months ended June 30, 2025 and 2024, respectively.

On March 29, 2023, the Consulting Agreement dated March 8, 2022 ( the “ Javitt Consulting Agreement ”) between the Company and Dr.

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Javitt’s continued engagement by the Company.

As of March 31, 2025 and 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.

As of June 30, 2025 and 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’s 2021 Omnibus Incentive Plan.

The restrictions are performance based, and half of the restricted shares ( 25,000 ) shall have the restrictions removed on the New Drug Application Date (as defined below) and the remaining half ( 25,000 ) will have the restrictions removed on the New Drug Approval Date (as defined below).

As of March 31, 2025, the Board of Directors has not approved the grant of restricted stock.

As of June 30, 2025, the Board of Directors has not approved the grant of restricted stock.

The term “New Drug Application Date” means the date upon which the FDA files the Company’s new drug application for the Antidepressant Drug Regimen (as defined below) for review.

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Zachary Javitt provides services related to website, IT, and marketing support under the supervision of the Company’s CEO who is responsible for assuring that the services are provided on financial terms that are at market.

The Company paid this family member a total of $ 0.1 million and $0.1 million during the three months ended March 31, 2025 and 2024, respectively.

The Company paid this family member a total of less than $ 0.1 million and less than $ 0.1 million during the three months ended June 30, 2025 and 2024, respectively.

The Company paid this family member a total of $ 0.1 million and less than $ 0.1 million during the six months ended June 30, 2025 and 2024, respectively.

These services are ongoing.

Included in accounts payable were $ 0.2 million and less than $0.1 million and less than $0.1 million due to the above related parties as of March 31, 2025 and December 31, 2024, respectively.

Included in accounts payable were $ 0.2 million and less than $ 0.1 million due to the above related parties as of June 30, 2025 and December 31, 2024, respectively.

Subsequent Events

On April 17, 2025, the Company increased the maximum aggregate offering price of the shares of the Company’s common stock, par value $ 0.001 per share issuable under that certain At the Market Offering Agreement, as amended with H.C.

Wainwright & Co., LLC, dated August 14, 2023, to $ 20,000,000 and filed a prospectus supplement under the Offering Agreement for an aggregate of $ 20,000,000 .

Prior to the date hereof, the Company sold shares of Common Stock having an aggregate sales price of approximately $2.0 million under the Offering Agreement.

The Company sold 64,263 shares of Common Stock with an aggregate sales price of approximately $ 0.1 million under the Offering Agreement subsequent to the quarter ended March 31, 2025.

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 entry into the Kadima Purchase Agreement follows the entry into that certain Membership Interest Purchase and Contribution Agreement (the “ Dura Purchase Agreement ”), dated March 29, 2025, by and among the Subsidiaries, Dura Medical, LLC, and Stephen Durand, CRNA, APRN.

As of the date of this Report, the transactions contemplated by each of the Kadima Purchase Agreement and the Dura Purchase Agreement have not yet been consummated.

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 and third-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, and the investment representations of Kadima.

The Kadima Purchase Agreement has been attached to provide investors with information regarding its terms.

It is not intended to provide any other factual information about the Subsidiaries or Kadima.

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 should not be relied on as characterization of the actual state of facts regarding the Subsidiaries and/or Kadima.

From July 9, 2025 through 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.

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

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NRx Pharmaceuticals, Inc.

(“ NeuroRx ”), novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, and post-traumatic stress disorder (“ PTSD ”) and now schizophrenia.

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.

The Company has two lead drug candidates that are expected to be submitted during the second quarter of 2025 for Food and Drug Administration (" FDA ") approval with anticipated FDA decision dates under the Prescription Drug User Fee Act (“ PDUFA ”) by year end 2025:

NRX-101, an oral fixed dose combination of D-cycloserine and lurasidone and NRX-100, a preservative-free formulation of ketamine for intravenous infusion.

The Company has two 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:

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.

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.

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.

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.

Fiscal 2024 and the first quarter of 2025 marked a period of both expansion and change for NRx.

Throughout this time, the Company implemented a restructuring of its leadership to address challenges related to capital formation, clinical trial enrollment, and corporate development.

These efforts led to measurable achievements throughout 2024 and the first quarter and positioned the Company for growth and the achievement of our development objectives in 2025.

During the first quarter of 2025 and in the subsequent period, key achievements by the Company include the following:

Completed formulation and stability assessment of its proprietary preservative-free ketamine product (NRX-100) with results sufficient to apply to the US Food and Drug Administration for three years of room temperature shelf stability, the maximum labeled shelf life allowed for sterile, injectable products

Filed an application with the United States Patent and Trademark Office (“USPTO”) for NRX-100, our proprietary, preservative free form of IV Ketamine;

the patent application was based on extensive prior art suggesting that preservatives, such as benzethonium chloride, were needed to maintain long-term stability and sterility of ketamine products.

Received notice of a filing fee waiver from the Food and Drug Administration (“FDA”) for the planned NRX-100 New Drug Application;

Entered into a strategic advisory agreement with BTIG, Inc.

(BTIG) to support the identification and acquisition of interventional psychiatry clinics to form the initial HOPE Therapeutics network, targeting total revenues on a pro-forma basis of $100 million by year-end 2025.

Identified and negotiated acquisition agreements with three clinical entities (as identified below) estimated to represent approximately $15 million in pro-forma revenues with targeted closing in the second quarter of 2025.

Identified and entered into negotiations with four additional clinical entities (not yet identified) estimated to represent $20 million in potential pro-forma revenue with targeted closing in the third quarter of 2025.

Executed definitive agreements to acquire the non-clinical assets of Kadima Neuropsychiatry Institute, which is expected to serve as the clinical model for treatment offerings in HOPE-acquired clinics and expected to continue its role as a leading investigative site for research into neuroplastic therapies including psychedelic medications, transcranial magnetic stimulation (TMS), and hyperbaric therapy;

Executed definitive agreement to acquire Dura Medical, a foundational clinic in Florida, which is expected to support and drive the acquisition of additional HOPE clinics to achieve critical mass in the region;

Executed a binding letter of intent to acquire a majority interest in NeuroSpa TMS Holdings, LLC, an operator of multiple clinics on the west coast of Florida

Executed a term sheet for $7.8 million in debt financing to support acquisition of HOPE Therapeutics clinics

Executed term sheet for a strategic investment in an amount of $2.5 million;

Completed the third tranche of a convertible note offering and registered direct equity offering to institutional investors on favorable terms to the Company expected to provide sufficient cash to support operations through the end of 2025.

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.

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 d efinitive Purchase Agreement and r eceipt 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 a ssets 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 non-binding term sheet for a strategic investment from a global medical device manufacturer into HOPE.

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

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Difficile infection.

Activities surrounding this development program, as well as chronic pain, are on hold into 2026 as the Company focuses on its nearer term, more significant development programs.

Recent Developments

We consummated a series of financing agreements with an institutional investor for up to $16.3 million in debt capital, for which we closed on $10.9 million in 2024 and an additional $5.4 million during the first quarter of 2025.

We also closed $3.5 million in an above-market registered direct common stock and warrant offering during the first quarter of 2025.

In May 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 the three months ended June 30, 2025 the Company sold an aggregate of 399,078 of its common stock shares for approximately $1.0 million, net of less than $0.02 million in offering costs.

We executed a term sheet with a publicly-traded strategic investor to provide additional capital to support the expansion of HOPE clinics.

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Drug Development

We filed module 3 (manufacturing) of our NDA for NRX-100 (preservative-free sterile ketamine) in a tamper-resistant, diversion resistant packaging presentation.

NRX-100 was previously granted Fast Track Designation by FDA in combination with use of NRX-101.

Ketamine efficacy data is in hand from four clinical trials.

Three manufacturing lots are now completed with filed stability data suitable for shelf life exceeding two years at room temperature.

The anticipated PDUFA date for this settlement is prior to December 30, 2025.

We also anticipate filing an Abbreviated New Drug Application (“ ANDA ”) for the use of preservative-free ketamine in all currently-indicated clinical applications.

We are engaged in the filing of a New Drug Application (“ NDA ”), which we anticipate filing during the second quarter of 2025, for Accelerated Approval under Breakthrough and Priority Review of NRX-101 in treatment of bipolar depression in people at risk of akathisia, based on the Phase 2b/3 and STABIL-B data.

Three manufacturing lots are now completed with more than 24 months of room temperature shelf-stability.

The anticipated PDUFA date for this application is prior to December 31, 2025.

Work is ongoing to prepare the module 3 manufacturing section documenting our transition from manufacturing at WuXi Apptec in Shanghai to manufacturing of NRX-101 in North Carolina with manufacture of three commercial lots.

We accepted a non-binding offer from a commercial pharmaceutical company to license and distribute NRX-100 (preservative-free ketamine) that provides for $325 million in potential milestones plus a sliding scale royalty that ranges from 11% - 16% of sales.

We initiated development of and plan to file a citizen’s petition with the FDA to remove benzethonium chloride, a known neurotoxic substance from presentations of ketamine intended for intravenous use.

Management believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxicity of benzethonium chloride in current generic products.

As a next-generation product, we developed a novel, patentable pH neutral formulation for ketamine (designed as HTX-100) that will be suitable for both intravenous and subcutaneous administration.

Initial laboratory lots demonstrate shelf stability and ongoing stability is being assessed.

Ketamine in its current commercial presentations cannot be administered subcutaneously because of its high acidic (pH 3.5-4.0) properties, an acidity range that is known to cause pain and skin ulcers.

We anticipate long-term patent protection on this novel product.

This product is expected to undergo clinical testing in 2025/2026 and be ready for FDA approval in 2027.

NRX-101 in the treatment of Complicated Urinary Tract Infection (“ cUTI ”) was granted Qualified Infectious Disease Product (“ QIDP ”), Fast Track, and Priority Review designations in 2024.

We have now demonstrated that NRX-101 does not damage the microbiome of the gut, in contrast to all other advanced antibiotics and is less likely to cause C.

Difficile infection (a potentially lethal side effect of antibiotic treatment).

NRx is reviewing partnership options.

We executed a Memorandum of Understanding with Foundation FundaMental for rights to develop a potential disease modifying drug for schizophrenia, autism, and acute mania.

If successful, this would represent the first drug to reverse the underlying disease mechanism of these conditions, rather than simply treating symptoms.

We filed an application with the United States Patent and Trademark Office (“USPTO”) for NRX-100, our proprietary, preservative-free form of IV Ketamine;

the patent application was based on extensive prior art suggesting that preservatives, such as benzethonium chloride, were needed to maintain long-term stability and sterility of ketamine products.

We received notice of a filing fee waiver from the Food and Drug Administration (“FDA”) for the planned NRX-100 New Drug Application.

HOPE Therapeutics

We partnered with representatives of ketamine clinic operators to construct a care platform that will include ketamine, operational support, and digital therapeutic extensions.

In advance of FDA approval, HOPE anticipates that it will supply ketamine under 503b pharmacy licensure to meet the national ketamine shortage declared by FDA.

We signed two definitive agreements and one binding letter of intent to acquire precision psychiatry centers, the closing of which is subject to certain conditions.

Although no assurances can be given, we are also currently negotiating the terms for the acquisition of six additional psychiatry centers, which are subject to due diligence review and execution of a letter of intent.

Upon closing, the acquisitions will form the foundation for the development of HOPE to achieve our objective of creating a national network offering interventional psychiatry to treat suicidal depression and PTSD.

We engaged BTIG, a leading investment bank, to support us in identifying and acquiring additional clinic candidates to join the HOPE network sufficient to achieve management’s revenue targets by year-end 2025.

Our potential acquisition targets have contracts with the Veterans Administration for the treatment of depression and, assuming closing of our previously announced acquisitions, we expect to expand to the treatment of PTSD by year-end 2025.

We executed a term sheet for a strategic investment in an amount of $2.5 million.

NRX-100 – Preservative-Free Ketamine:

As described in previous filings, we have undertaken two paths to market for NRX-100:

a generic-approval path under an Abbreviated New Drug Application (ANDA) to address the current generic market for ketamine and an innovative drug path under a New Drug Application (NDA) to develop ketamine for use in treating suicidal depression.

The ANDA market is estimated at $750 million today and we anticipate entering this market in early 2026.

There is one ketamine-based drug currently marketed for treatment of depression and its manufacturer recently reported $1.3 billion in 2024 sales.

With recent positive changes in the regulatory environment, we similarly anticipate entering the innovative market for ketamine in early-mid 2026.

Our proprietary, preservative free formulation is the subject of a US patent filing that has potential to confer market exclusivity.

In addition, we have filed a Citizens Petition (Sapko, M.

T., Panicucci, R., & Javitt, J.

Toxicological Evaluation of Benzethonium Chloride in Ketamine Formulations.

https://doi.org/10.5281/zenodo.16883346 ) with FDA noting that the Benzethonium Chloride (BZT) preservative in ketamine is not Generally Recognized as Safe (GRAS) and has not been demonstrated to be safe in the context of this product.

Historically, BZT was added to ketamine to enable multidose use and multi-patient use from a single vial.

Those uses are no longer common in US healthcare facilities.

We have performed an extensive review of the toxicology literature around BZT and determined that FDA no longer allows BZT to be used in hand cleansers and topical antiseptics.

BZT is part of a class of quaternary amines that have been shown to be toxic to corneal and conjunctival cells.

A related compound in this class, Benzalkonium Chloride, has been removed from many eyedrops because of this demonstrated toxicity.

The toxicology review link suggests that while single dose administration of preserved ketamine is generally thought of as safe, the cumulative dose of BZT with repeated intravenous administration may approach a toxicologically-concerning exposure to this compound.

In general, we anticipate that a preservative-free form of ketamine will be welcomed by physicians and patients, which may enable NRX-100 to gain a larger share of the existing ketamine market than would be available to an undifferentiated product.

However, should the Citizens Petition be granted the share of the generic market captured by NRX-100 could be considerably higher.

Our path to New Drug Approval of Ketamine for treatment of depression was substantially augmented on August 8, 2025 by award of an expanded Fast Track Designation (FTD) to NRX-100 by the FDA Division of Psychiatry Products.

In 2017, FDA awarded FTD to NRX-100 in association with NRX-101 for the treatment of suicidal bipolar depression.

FDA subsequently requested in 2018 that the Company establish a separate Investigative New Drug file for NRX-100 and the Company complied.

Last week, FDA gave a far broader Fast Track Designation to NRX-100, designating it for “Treatment of suicidal ideation in depression, including bipolar depression,” According to the US Centers for Disease Control (CDC), 13 million Americans develop suicidal ideation each year, with 1.5 million attempting suicide and an American dying of suicide every 11 minutes.

FDA further augmented the potential path to market of NRX-100 by establishing the Commissioner’s National Priority Voucher Program (CNPV).

The key criteria are shown below, taken from the FDA website.

To receive a CNPV, a product must meet at least one of the criteria below.

Management believes that NRX-100 meets all five criteria.

Addressing a U.S.

public health crisis.

An example could include developing a universal flu vaccine that could provide broad protection against multiple strains of influenza, including those with pandemic potential.

Delivering more innovative cures for the American people.

The focus for this priority is transformative impact that far outstrips the threshold for breakthrough therapy designation.

Examples could include creating a novel immunotherapy that reprograms the body’s immune system to fight multiple diseases;

or transforming mental health care through a novel treatment for PTSD.

Addressing a large unmet medical need.

This includes a condition that available therapies do not adequately diagnose or treat, including drugs to treat or prevent rare diseases or addressing America’s chronic disease crisis.

Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S.

supply chain resiliency.

Examples could include companies with new manufacturing establishments that shift manufacturing of essential medicines (such as generic sterile injectables) from foreign facilities to the U.S.;

or a clinical trial that maintains robust U.S.

enrollment to support generalizability for Americans against the U.S.

standard of care.

Increasing affordability.

This could include a company that lowers the U.S.

price of a drug or drugs consistent with Most Favored Nation pricing or reduces other downstream medical utilization to lower overall healthcare costs.

Receipt of a CNPV affords a substantially faster review time of 1-2 months vs.

10-12 months, enhanced communication throughout the review process, a multidisciplinary team-based evaluation, and potential for accelerated approval if the applicable requirements are met.

Key to this process is determination that the candidate product meets a large, unmet medical need.

That determination was specifically made in the case of NRX-100 by the Division of Psychiatry Products and included in the Fast Track Determination letter.

There is an additional feature to the CNPV that may limit eligibility to a relatively few drugs.

The CNPV requires that a Company’s module 3 manufacturing data be on file.

These data were initially filed for NRX-100 in December 2024 and the stability data were updated in July 2025 to support three years of room temperature shelf stability.

NRx intends to seek Accelerated Approval of NRX-100.

The data that have been licensed from the Government of France and Columbia University demonstrate that intravenous ketamine is superior to placebo and to active placebo in reducing suicidal ideation and depression within hours and has an effect duration of about a week.

The PCORI-funded trial of ketamine vs.

ECT demonstrates non-inferiority to ECT on depression over a 6 month period.

The Company believes that these data are sufficient for an FDA grant of initial market access subject to confirmatory data.

However, longer term data are desirable for a drug that may ultimately be used in millions of patients each year.

Additional detail regarding established ketamine efficacy data is noted below.

In addition to the experimental data shown above, the Company will be presenting Real World Data from two sources that capture medical record information from approximately 60,000 and 120,000 patients, respectively.

An example drawn from the first 20,000 such patients examined is depicted below and suggests that the effect of ketamine seen in Real World Data are consistent with the smaller, but better controlled results observed in randomized clinical trials.

Under the accelerated approval pathway, a Company is obligated to provide confirmatory data of safety and efficacy within five years of accelerated approval.

In this case, NRx has contracted with the sponsors of a 450-person randomized non-inferiority trial of intravenous racemic ketamine compared to intranasal S-ketamine.

The Company hypothesizes that NRX-100 will prove to be non-inferior to intranasal S-ketamine in reducing symptoms of depression and may prove superior in reducing symptoms of suicidality.

NRX-100 Path to Market

Both the ANDA and NDA pathways rely on the completion of the Module 3 manufacturing file.

The Abbreviated New Drug Application (ANDA) for NRX-100 was received by FDA on June 13, 2025.

On August 13, 2025, NRx Pharmaceuticals received a letter from the FDA in response to the Company’s Abbreviated New Drug Approval (ANDA) application for NRX-100 as enumerated in the Form 8-K filed August 15, 2025.

The Company will respond to the comments and resubmit the ANDA in cooperation with FDA.

Management believes that the guidance received by the FDA is a routine part of the regulatory process, provides a clear path to market for preservative-free ketamine, and will not result in any undue delay.

Clinical progress related to NRX-101 is documented in recently-filed forms 10-K and 10-Q.

During Q2 2025 and in subsequent events, management has focused on preparing the New Drug Application of NRX-101, submitting more than 80,000 pages of manufacturing, non-clinical, and clinical material in July 2025.

Breakthrough Therapy Designation was awarded to NRX-101 by the FDA in 2018.

As noted previously, NRX-101 demonstrated a statistically-significant benefit in reduction of suicidality and reduction of akathisia in a randomized, well-controlled trial against lurasidone.

These findings confirm the initial results reported in the Company’s STABIL-B trial.

The Company anticipates filing an NDA for Accelerated Approval of NRX-101 for treatment of “Suicidal Bipolar Depression in patients with Akathisia and Active Suicidal Ideation despite standard of care therapy.” NRX-101 is the only oral medicine that has ever been demonstrated in two randomized trials to reduce active suicidality and akathisia, to the Company’s knowledge.

The Company is in active discussion with an academic medical center that has already demonstrated leadership in the successful phase 2 trial to conduct the confirmatory research required post Accelerated Approval under an already-funded national multicenter trial.

The Company is currently applying for a PDUFA fee waiver from FDA on the grounds of overwhelming public health need.

Recent evidence suggests that NRX-101 may confer a significant added advantage to the clinical results of Transcranial Magnetic Stimulation (Cole J, et.al.

Efficacy of Adjunctive D-Cycloserine to Intermittent Theta-Burst Stimulation for Major Depressive Disorder:

A Randomized Clinical Trial.

JAMA Psychiatry.

2022;79(12):1153–1161.

doi:10.1001/jamapsychiatry.2022.3255).

The Company is initiating an expanded-access protocol to make NRX-101 available for this application and is organizing a phase 2b/3 randomized clinical trial to confirm this finding.

Financial Results

Since inception, the Company has incurred significant operating losses.

For the three months ended March 31, 2025 and 2024, the Company’s net loss was $5.5 million and $6.1 million, respectively.

As of March 31, 2025, the Company had an accumulated deficit of $283.8 million, a stockholders’ deficit of $25.2 million and a working capital deficit of $25.5 million.

For the three months ended June 30, 2025 and 2024, the Company’s net loss was $17,581 million and $7.9 million, respectively.

For the six months ended June 30, 2025 and 2024, the Company’s net loss was $23.1 million and $14.4 million, respectively.

As of June 30, 2025, the Company had an accumulated deficit of $301.4 million, a stockholders’ deficit of $35.6 million and a working capital deficit of $35.9 million.

Going Concern

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Settlement expense

Settlement expense during the three months ended March 31, 2025 consists of deductibles related to insurance claims.

Results of operations for the three months ended March 31, 2025 and 2024

Settlement expense during the six months ended June 30, 2025 consists of deductibles related to insurance claims.

Results of operations for the three months ended June 30, 2025 and 2024

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

Three months ended March 31,

Three months ended June 30,

Operating expense:

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General and administrative

Total operating expense

Loss from operations

Other expense (income):

Interest income

Convertible note default penalty

Change in fair value of convertible note payable

Change in fair value of warrant liabilities

Loss on convertible note conversion

Total other expense

Loss before tax

Operating expense

Research and development expense

For the three months ended June 30, 2025, the Company recorded $1.0 million of research and development expense, as compared to approximately $2.8 million for the three months ended June 30, 2024.

The decrease of $1.8 million is related primarily due to the conclusion of the phase 2 study related to NRX-101 and the Company's cash conservation efforts, specifically to reduction in $0.4 million in clinical costs, $1.5 million in other regulatory and process development costs, and less than $0.1 million in payroll and payroll related expenses.

The research and development expense for each of the three months ended June 30, 2025 and 2024, includes less than $0.1 million of non-cash stock-based compensation.

General and administrative expense

For the three months ended June 30, 2025, the Company recorded $2.7 million of general and administrative expense, as compared to approximately $4.2 million for the three months ended June 30, 2024.

The decrease of $1.5 million is related primarily to a decrease of $1.2 million in consultant and legal fees, $0.1 million in insurance expense and $0.2 million in employee expenses and other general and admin expenses.

General and administrative expense includes less than $0.1 million of non-cash stock-based compensation for both of the three months ended June 30, 2025 and 2024.

Other expense (income)

Interest income

For the three months ended June 30, 2025, the Company recorded less than $0.1 million of interest income, as compared to less than $0.1 million of interest income for the three months ended June 30, 2024.

Convertible note default penalty

For the three months ended June 30, 2025, the Company recorded $0 million of a default penalty, as compared to $0.8 million of a default penalty for the three months ended June 30, 2024.

The decrease is due to alleged default in connection with the convertible note during the three months ended June 30, 2024.

Change in fair value of convertible notes payable

For three months ended June 30, 2025, the Company recorded a loss of $5.6 million related to the change in fair value of the convertible notes payable which are accounted for under the fair value option.

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

Change in fair value of warrant liabilities

For the three months ended June 30, 2025, the Company recorded a loss of $6.4 million related to the change in fair value of the warrant liabilities, as compared to a gain of less than $0.1 million for the three months ended June 30, 2024.

The increase in loss during the three months ended June 30, 2025 was attributed to the warrants issued in conjunction with the First, Second and Third Tranches of the Anson Notes as well as increase in the Company’s stock prices.

Loss on convertible note conversion

For the three months ended June 30, 2025, the Company recorded a loss of $1.9 million related to convertible note conversion, as compared to $0 during the three months ended June 30, 2024.

These conversions were calculated as the difference between the conversion price per the terms of the Anson agreement (See Note 7) relative to the fair value of the common stock on the date of conversion.

Results of operations for the six months ended June 30, 2025 and 2024

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

Six months ended June 30,

Operating expense:

Research and development

General and administrative

Settlement Expense

4 unchanged sentences

Interest expense

Change in fair value of convertible notes payable

Convertible note default penalty

Change in fair value of convertible note payable

Change in fair value of warrant liabilities

Loss on issuance of Registered Direct Offering common shares

Loss on issuance of the Registered Direct Offering

Loss on Considerations Shares and Warrants

Loss on convertible note redemptions

Total other expense

Loss on convertible note conversion

Total other (income) expense

Loss before tax

1 unchanged sentence

Research and development expense

For the three months ended March 31, 2025, the Company recorded $0.8 million of research and development expense compared to approximately $1.7 million for the three months ended March 31, 2024.

The decrease of $0.9 million is related primarily due to the conclusion of the phase 2 study related to NRX-101 and the Company's cash conservation efforts, $0.4 million in clinical costs, $0.1 million in shipping, freight, and delivery, $0.4 million in other regulatory and process development costs, and $0.2 million in payroll and payroll related expenses.

The research and development expense for the three months ended March 31, 2025 and 2024, respectively, includes less than $0.1 million and $0.1 million, respectively of non-cash stock-based compensation.

For the six months ended June 30, 2025, the Company recorded $1.8 million of research and development expense, as compared to approximately $4.6 million for the six months ended June 30, 2024.

The decrease of $2.8 million is related primarily due to the conclusion of the phase 2 study related to NRX-101 and the Company's cash conservation efforts, $0.8 million in clinical costs, $1.5 million in other regulatory and process development costs, and $0.5 million in regulatory and process consultants fees.

The research and development expense for each of the six months ended June 30, 2025 and 2024, respectively, includes less than $0.1 million of non-cash stock-based compensation.

General and administrative expense

For the three months ended March 31, 2025, the Company recorded $2.9 million of general and administrative expense compared to approximately $4.3 million for the three months ended March 31, 2024.

The decrease of $1.3 million is related primarily to a decrease of less than $0.1 million in insurance expense, $0.2 million in stock-based compensation expense, $1.2 million in consultant fees, and $0.2 million in employee expenses partially offset by an increase of $0.4 million in legal expense.

The general and administrative expense for the three months ended March 31, 2025 and 2024, respectively, includes less than $0.1 million and $0.2 million, respectively, of non-cash stock-based compensation.

For the six months ended June 30, 2025, the Company recorded $5.7 million of general and administrative expense, as compared to approximately $8.5 million for the six months ended June 30, 2024.

The decrease of $2.8 million is related primarily to a decrease of $2.1 million in consultant fees, $0.2 million in insurance expense, and $0.6 million in employee expenses and other general and admin expenses, partially offset by an increase of $0.1 million in legal expense.

General and administrative expense includes $0.2 million and $0.3 million of non-cash stock-based compensation for the six months ended June 30, 2025 and 2024, respectively.

Settlement expense

Settlement expense during the three months ended March 31, 2025 consists of $0.1 million of deductibles related to insurance claims, as compared to $0 during the three months ended March 31, 2024.

Settlement expense during the six months ended June 30, 2025 consists of $0.1 million of deductibles related to insurance claims, as compared to $0 during the six months ended June 30, 2024.

Other expense (income)

Interest income

For the three months ended March 31, 2025, the Company recorded less than $0.1 million of interest income compared to $0.1 million of interest income for the three months ended March 31, 2024.

The decrease of less than $0.1 million is due is due to a large decrease in the balance in the Company’s money market account at March 31, 2025 as compared to the prior year.

For the six months ended June 30, 2025, the Company recorded less than $0.1 million of interest income, as compared to less than $0.1 million of interest income for the six months ended June 30, 2024.

Interest expense

For the three months ended March 31, 2025, the Company recorded $0 of interest income compared to less than $0.2 million of interest expense for the three months ended March 31, 2024.

The decrease of less than $0.2 million is due to no premiums being paid on the convertible notes.

For the six months ended June 30, 2025, the Company recorded $0 of interest expense, as compared to $0.2 million of interest expense for the six months ended June 30, 2024.

The decrease of $0.2 million is due to premiums for cash payments on the convertible note for the six months ended June 30, 2024.

Convertible note default penalty

For the six months ended June 30, 2025, the Company recorded $0 million of a default penalty, as compared $0.8 million of a default penalty for the six months ended June 30, 2024.

The decrease is due to alleged default in connection with the convertible note in 2024 and no such event of default during the six months ended June 30, 2025.

Change in fair value of convertible notes payable

For three months ended March 31, 2025, the Company recorded a loss of $0.9 million related to the change in fair value of the convertible notes payable which are accounted for under the fair value option.

For the three months ended March 31, 2024, the Company recorded a loss of approximately $0.3 million related to the change in fair value of the convertible notes payable which are accounted for under the fair value option.

For six months ended June 30, 2025, the Company recorded a loss of $6.5 million related to the change in fair value of the convertible notes payable which are accounted for under the fair value option.

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

Change in fair value of warrant liabilities

For the three months ended March 31, 2025, the Company recorded a gain of $2.9 million related to the change in fair value of the warrant liabilities compared to a loss of less than $0.1 million for the three months ended March 31, 2024.

The decrease in loss during the three months ended March 31, 2025 was attributed to the warrants issued in conjunction with the First, Second and Third Tranches of the Anson Notes.

For the six months ended June 30, 2025, the Company recorded a loss of $3.5 million related to the change in fair value of the warrant liabilities, as compared to a gain of less than $0.1 million for the six months ended June 30, 2024.

The increase in loss during the six months ended June 30, 2025 was attributed to the warrants issued in conjunction with the First, Second and Third Tranches of the Anson Notes as well as increase in the Company’s fair value of its common shares.

Loss on issuance of Registered Direct Offering

For the three months ended March 31, 2025, the Company recorded a loss of $0.7 million related to the issuance of Registered Direct Offering.

As the fair value of the warrant liabilities issued in the Registered Direct Offering 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 the period ended March 31, 2025.

For the six months ended June 30, 2025, the Company recorded a loss of $0.7 million related to the issuance of Registered Direct Offering, as compared to $0 during the six months ended June 30, 2024.

Loss on Considerations shares and warrants

For the three months ended March 31, 2025, the Company recorded a loss of $1.3 million related to the loss on issuance of Consideration Shares and Warrants.

Loss on convertible note redemptions

For the three months ended March 31, 2025, the Company recorded a loss of $1.6 million related to convertible note redemptions.

These redemptions were calculated as the difference between the redemption price per the terms of the Anson agreement (See Note 7) relative to the fair value of the common stock on the date of redemption.

For the six months ended June 30, 2025, the Company recorded a loss of $1.2 million related to the loss on issuance of Consideration Shares and Warrants, as compared to $0 during the six months ended June 30, 2024.

Loss on convertible note conversion

For the three months ended June 30, 2025, the Company recorded a loss of $3.5 million related to convertible note conversion, as compared to $0 during the six months ended June 30, 2024.

Liquidity and Capital Resources

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This could negatively impact our business and operations and could also lead to the reduction of our operations.

January 2025 Securities Purchase Agreement

On or about January 27, 2025, the Company entered into the RD Purchase Agreement with the Investors for the sale by the Company of the RD Shares to the Investors in an aggregate of 1,215,278 shares of common stock, at a purchase price of $2.88 per share, in 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 the unregistered RD Warrants to purchase 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 RD Warrants are exercisable for five years from the RD Closing Date.

The closing of the sales of these securities under the RD Purchase Agreement occurred on or about the RD Closing Date.

The gross proceeds to the Company from the offerings were approximately $3.5 million, before deducting offering expenses, and excluding the proceeds, if any, from the exercise of the RD Warrants.

The Company intends to use the net proceeds from the transactions for general corporate purposes, including the funding of certain capital expenditures.

The RD Shares were offered and sold by the Company pursuant to an effective shelf registration statement on Form S-3, which was filed with the SEC on June 9, 2022, and subsequently declared effective on June 21, 2022 (File No.

333-265492) (the “Registration Statement”), and the base prospectus dated as of June 21, 2022, contained therein, as supplemented by a prospectus supplement dated January 27, 2025 (together, the “Prospectus”), which was filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended.

Pursuant to the Prospectus, the Company offered and sold 1,215,278 shares of its Common Stock at a price of $2.88 per share, resulting in gross proceeds of $3.5 million and net proceeds of approximately $3.3 million, after deducting offering expenses.

The RD Warrants and the RD Warrant Shares were sold and issued without registration under the Securities Act of 1933, as amended (the “Securities Act”), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering and Rule 506 promulgated under the Securities Act as sales to accredited investors, and in reliance on similar exemptions under applicable state laws.

August 2024 SPA

On August 12, 2024, the Company executed the August SPA and related agreements, under which the Company agreed to sell and issue, and certain purchasers agreed to purchase, an aggregate of $16.3 million of Notes and Warrants.

The consideration payable by the purchasers under the August SPA will be comprised of three equal closings of $5.4 million, each subject to certain closing conditions.

The proceeds arising from the sale of the Notes and the Warrants were used to settle the Company’s outstanding amounts owed to Streeterville and other working capital needs.

The Company has, as of the date of this Annual Report, consummated the first tranche, second tranche, and third tranche under the August SPA, with gross proceeds to the Company of $16.3 million.

The Notes bear interest at the rate of 6% per annum and mature in 15 months following their date of issuance.

The Notes may be settled in cash or in shares of the Company’s common stock, at the sole discretion of the holder, at the applicable conversion price.

The Notes may not be prepaid by the Company however, the holders of the Notes may elect to convert the Notes, in whole or in part, into shares of the Company’s common stock at any time after the original issuance date.

The conversion price:

(A) for the Notes issued in the first tranche will equal the lower of (i) $2.4168, or (ii) the Alternative Conversion Price;

(B) for the Notes issued in the second tranche will equal the lower of (i) $1.766, or (ii) the Alternative Conversion Price;

and (C) for the Notes issued in the third tranche will equal the lower of (i) $3.78, or (ii) the Alternative Conversion Price.

The Notes include certain redemption, protection features and default interest and penalties.

The Notes are secured by all assets of the Company, including its intellectual property.

The Warrants have a term of 5 years, an exercise price of $2.4168 per share for the Warrants issued in the first tranche, $1.766 per share for the Warrants issued in the second tranche, and $3.78 per share for the Warrants issued in the third tranche, each subject to adjustment as more specifically set forth in the Warrants, and are exercisable immediately upon issuance

April 2024 Offering

On April 18, 2024, we entered into the April Underwriting Agreement with the Representative, as the representative of the April Underwriters, relating to the April Offering of the Shares, which April Offering closed on the April Closing Date.

The public offering price for each share of common stock was $3.30.

Pursuant to the April Underwriting Agreement, the Company also granted the Representative the April Over-Allotment Option.

Aggregated gross proceeds from the April Underwriting Agreement were approximately $2.4 million (including April Overallotment Exercise proceeds), before deducting and commissions and estimated expenses payable by the Company.

The Company intends to use the net proceeds from the April 2024 Public Offering for working capital and general corporate purposes.

On May 23, 2024, the Underwriters in the April 2024 Public Offering exercised their April Over-Allotment Option to purchase an additional 91,050 April Option Shares.

In connection with the April Overallotment Exercise, we issued an additional April Underwriter Warrant to purchase up to 4,553 shares of common stock.

The April Overallotment was exercised in full and closed on May 23, 2024.

February 2024 Offerings

On February 27, 2024, the Company entered into a February Underwriting Agreement with EF Hutton LLC, as the Representative of the February Underwriters, relating to the February 2024 Public Offering.

The public offering price for each share of common stock was $3.00 and the February Underwriters purchased the shares of common stock pursuant to the February Underwriting Agreement at a price for each share of common stock of $2.76.

Pursuant to the February Underwriting Agreement, the Company also granted the Representative the February Over-Allotment Option.

Aggregate gross proceeds from the February Underwriting Agreement were approximately $1.7 million (including February Overallotment Exercise proceeds), before deducting underwriting discounts and commissions and estimated expenses payable by the Company.

The Company intends to use the net proceeds from the February 2024 Public Offering for working capital and general corporate purposes.

The Company also used the proceeds from February 2024 Public Offering to repay the Convertible Promissory Note initially issued to Streeterville Capital, LLC in November 2022.

On March 5, 2024, the Underwriters in the February 2024 Public Offering exercised their February Over-Allotment Option to purchase an additional 75,000 February Option Shares.

In connection with the February Overallotment Exercise, we issued an additional February Underwriter’s Warrant to purchase up to 3,750 shares of common stock.

The February Overallotment Exercise closed on March 6, 2024.

On February 29, 2024, the Company completed the February 2024 Private Placement.

Pursuant to the securities purchase agreement, the Company issued and sold 270,000 shares of common stock and warrants to purchase up to 270,000 shares of common stock at a price of $3.80 per share of common stock and accompanying warrant, which represents a 26.7% premium to the offering price in February 2024 Public Offering.

The common stock and the February Warrants were offered pursuant to a private placement under Section 4(a)(2) of the Securities Act.

The February Warrants will have an exercise price of $3.80 per share, are initially exercisable beginning six months following the date of issuance, and will expire 5 years from the date of issuance.

The aggregate net cash proceeds to the Company from the February 2024 Private Placement were approximately $1.0 million.

At-The Market Offering Agreement

On April 15, 2024, the Company increased the maximum aggregate offering amount of the shares of common stock issuable under that certain At the Market Offering Agreement, dated August 14, 2023 (the “Offering Agreement”), with H.C.

Wainwright & Co., and filed a prospectus supplement (the “Current Prospectus Supplement”) under the Offering Agreement for an aggregate of $4.9 million (the “ATM Offering”).

Wainwright & Co., and filed a prospectus supplement under the Offering Agreement for an aggregate of $4.9 million (the “ATM Offering”).

On August 14, 2024, the Company reduced the amount to under the Offering Agreement to $0 and suspended the ATM Offering.

Through March 31, 2025, the Company received aggregate net cash proceeds to the Company from the ATM Offering of approximately $1.6 million.

On April 17, 2025, the Company reinstated the ATM Offering and filed a prospectus supplement under the Offering Agreement for an aggregate of $20 million.

Through June 30, 2025, the Company received aggregate net cash proceeds to the Company from the ATM Offering of approximately $2.8 million.

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

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Total stockholders' deficit

Six months ended

Statement of Cash Flow Data:

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Operating Activities

During the three months ended March 31, 2025, operating activities used approximately $3.5 million of cash, primarily resulting from a net loss of $5.5 million partially offset by net non-cash losses of $2.0 million, including $1.0 million in change in fair value of convertible promissory notes, $0.1 of stock-based compensation, $1.6 million loss in convertible note redemptions, $1.3 million of loss on debt settlement, $0.4 million in debt issuance costs, $0.7 in loss on issuance of Register Direct offering and changes in operating assets and liabilities of less than $0.1 million, offset by a gain of $2.9 million in change in fair value of warrants.

During the three months ended March 31, 2024, operating activities used approximately $3.7 million of cash, primarily resulting from a net loss of $6.5 million partially offset by net non-cash losses of $0.6 million, including $0.3 million in change in fair value of convertible promissory note, and $0.2 million of stock-based compensation, and changes in operating assets and liabilities of $2.3 million.

During the six months ended June 30, 2025, operating activities used approximately $7.5 million of cash, primarily resulting from a net loss of $23.1 million partially offset by net non-cash losses of $16.1 million, including $6.5 million in change in fair value of convertible promissory notes, $0.2 million of stock-based compensation, $3.5 million loss in convertible note conversion, $1.2 million of loss on Consideration Shares and Warrants, $0.4 million in debt issuance costs, $0.7 million in loss on issuance of Register Direct offering, $3.5 million loss in change in fair value of warrant liabilities and changes in operating assets and liabilities of $0.5 million.

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

Investing Activities

During the three months ended March 31, 2025 and 2024 there was $0 of investing activities.

During the six months ended June 30, 2025 and 2024, there was no cash used in investing activities.

Financing Activities

During the three months ended March 31, 2025, financing activities provided $7.6 million of cash resulting from $3.3 million in proceeds from issuance of common stock and warrants related to the RD Offering and $5.0 million in proceeds from the Anson Notes, offset by $0.3 million in repayments of insurance notes and $0.4 million in debt issuance costs due to the fair value election on Anson Notes.

During the three months ended March 31, 2024, financing activities provided $0.4 million of cash resulting from $1.0 million in proceeds from issuance of Common Stock and warrants issued in a private placement, and $1.5 million in proceeds from issuance of Common Stock and warrants offset by $2.2 million in repayments of the convertible note.

During the six months ended June 30, 2025, financing activities provided $9.0 million of cash resulting from $3.3 million in proceeds from issuance of common stock and warrants related to the RD Offering and $5.0 million in proceeds from the Anson Notes, $1.0 million in proceeds from issuance of common stock in connection with ATM offering, offset by $0.3 million in repayments of and by $0.4 million of proceeds from insurance notes, and $0.4 million in debt issuance costs due to the fair value election on Anson Notes.

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

Contractual Obligations and Commitments

See Note 7, Debt, and Note 8, Commitments and Contingencies, of the notes to the Company’s condensed consolidated financial statements as of and for the three months ended March 31, 2025 included elsewhere in this report for further discussion of the Company’s commitments and contingencies.

See Note 7, Debt, and Note 8, Commitments and Contingencies, of the notes to the Company’s condensed consolidated financial statements as of and for the three months ended June 30, 2025 included elsewhere in this report for further discussion of the Company’s commitments and contingencies.

Milestone Payments

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What changed 10-Q

Item 1. Financial Statements