[10-Q] NRX Pharmaceuticals, Inc. Quarterly Earnings Report
NRx Pharmaceuticals (NRXP) reported a larger loss and ongoing financial strain for the nine months ended September 30, 2025, while advancing its drug pipeline and launching clinical operations. The company recorded a net loss of about
Cash and cash equivalents were
- Regulatory progress: Expanded FDA fast-track designation for NRX-100 across depression and related disorders, ANDA refiling without identified major deficiencies, and NDA-supporting data for NRX-101.
- Clinical revenue initiation: Acquisition of Dura Medical turned HOPE into a revenue-generating platform, adding approximately
$0.242 million in patient service revenue in the quarter. - Access to capital: Multiple financings (registered direct offerings, Anson notes, ATM sales, and warrant exercises) provided over
$18 million of net cash from financing activities in the first nine months of 2025.
- Going concern risk: Management concluded substantial doubt exists about the ability to continue as a going concern, reflecting tight liquidity and heavy obligations.
- Persistent losses and deficit: Nine-month net loss of about
$28.9 million and accumulated deficit of roughly$307.3 million with stockholders’ deficit of$25.8 million . - Leveraged balance sheet: Total liabilities of
$40.751 million exceed total assets of$14.996 million , with significant warrant and convertible note-related liabilities.
Insights
NRx advances ketamine programs and HOPE clinics but remains highly leveraged with going concern risk.
NRx Pharmaceuticals reported a nine‑month net loss of
To sustain operations, NRx relied heavily on external financing: two registered direct offerings generated roughly
Operationally, the acquisition of Dura Medical converted HOPE into a revenue‑generating clinical platform, contributing approximately
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
For the Quarterly Period Ended:
For the transition period from to
Commission File Number:
NRX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| | |
| (State or other jurisdiction of | (I.R.S. Employer |
| incorporation or organization) | Identification No.) |
(Address of principal executive offices) (Zip Code)
(
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class: | Trading Symbol(s) | Name of each exchange on which registered: | ||
| | | The | ||
| | | The |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ |
| | Smaller reporting company |
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of November 13, 2025, the registrant had
TABLE OF CONTENTS
| Page |
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| PART I - FINANCIAL INFORMATION |
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| ITEM 1. |
Financial Statements |
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| Condensed Consolidated Balance Sheets as of September 30, 2025 (Unaudited) and December 31, 2024 |
3 |
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| Unaudited Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2025 and 2024 |
4 |
|
| Unaudited Condensed Consolidated Statements of Changes in Stockholders' Deficit for the three and nine months ended September 30, 2025 and 2024 |
5 |
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| Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 |
7 |
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| Notes to Unaudited Condensed Consolidated Financial Statements |
8 |
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| ITEM 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
44 |
| ITEM 3. |
Quantitative and Qualitative Disclosures About Market Risk |
61 |
| ITEM 4. |
Controls and Procedures |
62 |
| PART II - OTHER INFORMATION |
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| ITEM 1. |
Legal Proceedings |
62 |
| ITEM 1A. |
Risk Factors |
63 |
| ITEM 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
63 |
| ITEM 3. |
Defaults Upon Senior Securities |
64 |
| ITEM 4. |
Mine Safety Disclosures |
64 |
| ITEM 5. |
Other Information |
64 |
| ITEM 6. |
Exhibits |
64 |
| SIGNATURES |
65 |
|
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
NRX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable, net | ||||||||
| Prepaid expense and other current assets | ||||||||
| Subscription receivable | ||||||||
| Total current assets | ||||||||
| Other assets | ||||||||
| Furniture and equipment, net | ||||||||
| Right-of-use assets, net | ||||||||
| Right-of-use asset - related party, net | ||||||||
| Intangible assets, net | ||||||||
| Goodwill | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued and other current liabilities | ||||||||
| Accrued clinical site costs | ||||||||
| Convertible note payable and accrued interest, current | ||||||||
| Insurance loan payable | ||||||||
| Warrant liabilities | ||||||||
| Lease liability, short term | ||||||||
| Lease liability, short term - related party | ||||||||
| Total current liabilities | ||||||||
| Convertible note payable and accrued interest, long term | ||||||||
| Lease liability, noncurrent | ||||||||
| Lease liability, noncurrent - related party | ||||||||
| Total liabilities | ||||||||
| Commitments and Contingencies (Note 11) | ||||||||
| Stockholders’ deficit: | ||||||||
| Preferred stock, $ par value, shares authorized. | ||||||||
| Series A convertible preferred stock, $ par value, shares authorized; shares issued and outstanding as of September 30, 2025 and December 31, 2024 | ||||||||
| Common Stock, $ par value, shares authorized; and shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ deficit | ( | ) | ( | ) | ||||
| Total liabilities and stockholders' deficit | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
NRX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net patient service revenue | $ | $ | $ | $ | ||||||||||||
| Operating expense: | ||||||||||||||||
| Cost of patient services | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling, general and administrative | ||||||||||||||||
| Depreciation and amortization | ||||||||||||||||
| Settlement (income) expense | ( | ) | ||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other (income) expense: | ||||||||||||||||
| Interest income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest expense | ||||||||||||||||
| Change in fair value of convertible notes payable | ( | ) | ( | ) | ||||||||||||
| Change in fair value of warrant liabilities | ( | ) | ( | ) | ||||||||||||
| Loss on issuance of Registered Direct Offering | ||||||||||||||||
| Loss on Consideration Shares and Warrants | ||||||||||||||||
| Convertible note default penalty | ||||||||||||||||
| Loss on convertible note conversions | ||||||||||||||||
| Gain on exercise of warrant liabilities | ( | ) | ( | ) | ||||||||||||
| Total other expense (income) | ( | ) | ( | ) | ||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Comprehensive loss: | ||||||||||||||||
| Change in fair value of convertible note attributed to credit risk | ||||||||||||||||
| Other comprehensive loss | ||||||||||||||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average Common Stock outstanding: | ||||||||||||||||
| Basic and diluted | ||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
NRX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
(in thousands, except share data)
(Unaudited)
| Accumulated | ||||||||||||||||||||||||||||||||||||||||
| Series A Preferred | Additional | Other | Total | |||||||||||||||||||||||||||||||||||||
| Preferred Stock | Stock | Common Stock | Paid-in- | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Loss | Deficit | |||||||||||||||||||||||||||||||
| Balance - December 31, 2024 | — | $ | — | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | |||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | ||||||||||||||||||||||||||||||||||||
| Shares issued as repayment of principal and interest for convertible note | — | — | ||||||||||||||||||||||||||||||||||||||
| Shares issued with register direct offering, net of offering cost | — | — | ||||||||||||||||||||||||||||||||||||||
| Fair Value of warrants issued with registered direct offering | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Amortization of prepaid offering costs | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Shares issued as a result of repricing under VWAP | — | — | ||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Balance - March 31, 2025 | — | $ | — | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | |||||||||||||||||||||||||||
| Common Stock issued in exchange for services | — | — | ||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | ||||||||||||||||||||||||||||||||||||
| Shares issued as repayment of principal and interest for convertible note | — | — | ||||||||||||||||||||||||||||||||||||||
| Amortization of prepaid offering costs | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| ATM offering, net of offering costs of $ | — | — | ||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Balance - June 30, 2025 | — | $ | — | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | |||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | ||||||||||||||||||||||||||||||||||||
| Common Stock issued as a result of exercise of warrants | ||||||||||||||||||||||||||||||||||||||||
| ATM offering, net of offering costs of $ | — | — | ||||||||||||||||||||||||||||||||||||||
| Common Stock issued in exchange for services | — | — | ||||||||||||||||||||||||||||||||||||||
| Shares issued as repayment of principal and interest for convertible note | — | — | ||||||||||||||||||||||||||||||||||||||
| Shares issued with register direct offering, net of offering cost of $ | — | — | ||||||||||||||||||||||||||||||||||||||
| Amortization of prepaid offering costs | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Balance - September 30, 2025 | — | $ | — | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | |||||||||||||||||||||||||||
| Accumulated | ||||||||||||||||||||||||||||||||||||||||
| Series A Preferred | Additional | Other | Total | |||||||||||||||||||||||||||||||||||||
| Preferred Stock | Stock | Common Stock | Paid-in- | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Loss | Deficit | |||||||||||||||||||||||||||||||
| Balance December 31, 2023 | — | $ | — | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | ||||||||||||||||||||||||||||||||||||
| Conversion of Series A preferred stock into common stock | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||
| At-the-market "ATM" offering, net of offering costs of $ | — | — | ||||||||||||||||||||||||||||||||||||||
| Common Stock and warrants issued, net of issuance costs of $ | — | — | ||||||||||||||||||||||||||||||||||||||
| Common Stock and warrants issued in private placement | — | — | ||||||||||||||||||||||||||||||||||||||
| Warrants issued pursuant to the Alvogen Agreement amendment (see Note 9) | — | — | — | — | ||||||||||||||||||||||||||||||||||||
| Vesting of restricted stock awards | — | — | ||||||||||||||||||||||||||||||||||||||
| Shares issued as repayment of principal and interest for convertible note | — | — | ||||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Balance - March 31, 2024 | — | $ | — | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | ||||||||||||||||||||||||||||||||||||
| ATM offering, net of offering costs of $ | — | — | ||||||||||||||||||||||||||||||||||||||
| Common Stock and warrants issued, net of issuance costs of $ | — | — | ||||||||||||||||||||||||||||||||||||||
| Issuance of shares related to reverse stock split | — | — | — | 73,040 | — | — | — | — | — | |||||||||||||||||||||||||||||||
| Contract cost related to Alvogen termination (see Note 9) | — | — | — | — | ||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Balance - June 30, 2024 | — | $ | — | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | ||||||||||||||||||||||||||||||||||||
| ATM offering, net of offering costs of $ | — | — | ||||||||||||||||||||||||||||||||||||||
| Common Stock issued in exchange for services | — | — | ||||||||||||||||||||||||||||||||||||||
| Shares issued as repayment of principal and interest for convertible note | — | — | ||||||||||||||||||||||||||||||||||||||
| Reclassification of AOCI upon settlement of Streeterville Note | — | — | — | — | ||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Balance - September 30, 2024 | — | $ | — | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | |||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
NRX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
| Nine Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization expense | ||||||||
| Amortization of operating right of use assets | ||||||||
| Stock-based compensation | ||||||||
| Common Stock issued in exchange for services | ||||||||
| Change in fair value of warrant liabilities | ( | ) | ||||||
| Change in fair value of convertible promissory notes | ( | ) | ||||||
| Loss on convertible note conversions | ||||||||
| Gain on exercise of warrant liabilities | ( | ) | ||||||
| Loss on issuance of registered direct Common Stock | ||||||||
| Loss on consideration shares and warrants | ||||||||
| 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: | ||||||||
| Prepaid expense and other assets | ( | ) | ||||||
| Account receivable | ||||||||
| Accounts payable | ||||||||
| Insurance loan payable | ||||||||
| Operating lease liabilities | ( | ) | ||||||
| Accrued expense and other liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Business acquisition, net of cash acquired | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Repayment of convertible note | ( | ) | ||||||
| Repayment of insurance note | ( | ) | ||||||
| Expense for debt issuance costs due to fair value election on Anson Notes | ( | ) | ( | ) | ||||
| Proceeds from issuance of insurance loan | ||||||||
| Proceeds from Anson convertible note, net | ||||||||
| Proceeds from liability classified warrants | ||||||||
| ATM offering, net of offering costs | ||||||||
| Proceeds from issuance of Common Stock and warrants issued in registered direct offering, net of issuance costs | ||||||||
| Proceeds from issuance of Common Stock and warrants, net of issuance costs | ||||||||
| Proceeds from issuance of Common Stock and warrants issued in private placement, net of issuance costs | ||||||||
| Net cash provided by financing activities | ||||||||
| Net increase (decrease) in cash and cash equivalents | ( | ) | ||||||
| Cash and cash equivalents at beginning of period | ||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for taxes | $ | |||||||
| Non-cash investing and financing activities: | ||||||||
| Issuance of Common Stock as principal and interest repayment for convertible notes | $ | $ | ||||||
| Issuance of Common Stock warrants as offering costs | $ | $ | ||||||
| Exercise of the warrants for subscription receivable | $ | $ | ||||||
| Amortization of deferred offering costs to additional paid-in capital | $ | $ | ||||||
| Conversion of Series A preferred stock into Common Stock | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
NRX PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2025
(Unaudited)
Note 1. Organization
The Business
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”, “we”, “us” or “our”) is a clinical-stage bio-pharmaceutical company which develops and will distribute, through its wholly-owned operating subsidiary, NeuroRx, Inc., (“NeuroRx”), novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, post-traumatic stress disorder (“PTSD”) and schizophrenia. NRx is additionally the founder and majority owner of HOPE Therapeutics, Inc. (“HOPE”), a medical services company that offers interventional psychiatry care to patients with treatment-resistant depression and PTSD with a combination of neuroplastic drugs, transcranial magnetic stimulation (“TMS”), digital therapeutics, and hyperbaric therapy. All of our current drug development activities are focused on drugs that enhance “neuroplasticity” (growth of new brain connections) by modulating 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 – NRX-100, a preservative-free formulation of ketamine for intravenous infusion, and NRX-101, an oral fixed dose combination of D-cycloserine (“DCS”) and lurasidone. NRX-100 and NRX-101 are in the process of submission for Food and Drug Administration (“FDA”) approval as follows:
| 1. | An Abbreviated New Drug Application (“ANDA”) for NRX-100 was filed, with priority review requested, during the third quarter of 2025. After meeting with the FDA in August 2025, the Company re-filed the ANDA, following FDA notification of approval of a suitability petition for NRx’s proposed strength of preservative-free ketamine, KETAFREETM. On November 6, 2025, the Company received a communication from the FDA in which no significant deficiencies were identified in the revised filing. This letter is consistent with the Company’s ambition to launch KETAFREE™ in Q1 2026. The Company has additionally submitted a citizen petition seeking to have benzethonium chloride, a toxic preservative, removed from all current commercial presentations of ketamine. |
| 2. | A New Drug Application (“NDA”) for NRX-100, originally initiated during the fourth quarter of 2024, is expected to be completed in the fourth quarter 2025. This follows award of Fast Track Designation by the FDA for the Company’s expanded indication of “Treatment of Suicidal Ideation in Depression, including Bipolar Depression.” A key element of the Company’s PDUFA strategy has focused on obtaining data to confirm the ketamine efficacy seen in clinical trials conducted under governmental auspices in the US and France. The Company has now arranged to submit Real World Efficacy Data drawn from 65,000 patients treated for depression with intravenous ketamine compared to 6,000 patients treated with intranasal S-ketamine, which will be submitted as part of the NDA. An interim analysis drawn from the first 20,000 such patients suggests that IV ketamine may have a more rapid onset of action and larger magnitude of effect than nasal S-ketamine. The Company has applied to receive a Commissioner’s National Priority Voucher (CNPV), which could significantly reduce review time. The Company has completed all required manufacturing steps and demonstrated room temperature shelf stability to support a three year shelf life. |
| 3) | An NDA filing for NRX-101 has been initiated with the submission of the Module 3 manufacturing file to the FDA. The drug was previously awarded Breakthrough Therapy Designation and accordingly the Company is requesting rolling review from the NDA. Breakthrough Therapy Designation is granted by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions that address an unmet medical need and have demonstrated preliminary evidence of efficacy as determined by the FDA. Based on current data, the Company aims to seek accelerated approval for use of NRX-101 in patients with bipolar depression who exhibit suicidal ideation on currently approved medication. |
| 4) | In the third quarter, the Company was made aware of dramatic findings suggesting that low-dose D-cycloserine (the key ingredient in NRX-101) may increase the antidepressant and antisuicidal effects of TMS by more than 2-fold, as demonstrated in a randomized controlled trial and subsequently confirmed with real world experience and mechanistic studies. Accordingly, the Company has filed a protocol with the FDA to test the use of low-dose NRX-101 in conjunction with the one-day TMS protocol (ONE-D) that has been published in association with the FDA-cleared Ampa Health TMS device. Should this study demonstrate safety and efficacy, it could represent a dramatic expansion of the market for NRX-101 and have the potential to offer patients a rapid remission from severe depression and PTSD with a single day of treatment. Millions of Americans are expected to be treated with TMS in coming years. Success in this planned clinical trial would lead to a 2027 PDUFA date for this previously unanticipated indication. |
As previously announced, in February 2024, NRx incorporated HOPE Therapeutics, a medical care delivery organization focused on providing cutting-edge, comprehensive interventional psychiatric treatment with the most effective treatments available, including NMDA-targeted and other neuroplastic drugs, such as ketamine, Spravato and NRX-101, neuromodulatory devices, such as TMS, hyperbaric therapy, digital therapeutics, and medication management.
On December 2, 2024, HOPE formed HTX Management Company, LLC, a wholly owned subsidiary organized as a Delaware limited liability company, for the purpose of supporting future back end operations associated with the growing network of HOPE clinics.
On September 8, 2025, HOPE became a revenue-generating clinical enterprise through its completion of the previously announced acquisition of Dura Medical, LLC (“Dura”), a Florida limited liability company, and a revenue-generating clinical organization with locations in Naples and Ft. Myers, Florida. Founded in 2018, Dura offers precision-based interventional psychiatry services, including ketamine infusion therapy, TMS, Spravato®, stellate ganglion blocks, and psychotherapy (See Note 17).
Subsequent to the third quarter, the Company completed the previously announced addition of Cohen and Associates, based in Sarasota, FL, to the HOPE Network with a strategic minority investment, which expanded HOPE’s footprint on the West Coast of Florida, and related appointment of Dr. Rebecca Cohen as HOPE’s Medical Director. On November 10, 2025, HOPE announced completion of clinical training on the Ampa Health TMS device and initiation of the ONE-D protocol at its Florida locations. The ONE-D protocol has been reported in the peer-reviewed literature to achieve 87% response and 72% remission from severe depression at 6 weeks following a single day of TMS treatment, combined with D-cycloserine. HOPE is the first clinical enterprise to offer this one-day treatment protocol in Florida and one of the first to offer this therapy nationwide.
Through the third 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. | |
| ● | Re-filing of an ANDA for NRX-100 (preservative-free intravenous ketamine) following an FDA notice of suitability of its suitability petition for NRx’s proposed strength of preservative-free ketamine, KETAFREETM. On November 6, 2025, the Company received a communication from the FDA that did not identify any major deficiencies in the revised ANDA submission, consistent with ANDA approval in Q2 2026. | |
| ● | Filing of Commissioner’s National Priority Voucher application for intravenous ketamine (NRX-100). Subsequently, the Company was invited to attend a closed-door listening session with the FDA Commissioner and senior staff. | |
| ● | Submission of stability data for NRX-100 to the manufacturing data on file with the 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 Petition with the FDA 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 an NDA for NRX-101 in the treatment of patients with suicidal bipolar depression and akathisia despite treatment with already-approved medication. |
HOPE
| ● | Completed the acquisition of Dura and subsequent acquisition of an interest in Cohen. | |
| ● | Appointment of Dr. Rebecca Cohen as HOPE’s Medical Director | |
| ● | Completion of clinical training and First-in-Florida initiation of one-day depression treatment (ONE-D) utilizing D-cycloserine and the Ampa Health FDA-cleared TMS device. |
Note 2. Going Concern
The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the ordinary course of business. Since inception, the Company has incurred recurring operating losses and negative cash flows from operations. For the nine months ended September 30, 2025, the Company reported a net loss of approximately $
The Company generated initial patient service revenue of approximately $
As of September 30, 2025, the Company had $
On August 18, 2025, the Company entered into a securities purchase agreement (the “Second RD Purchase Agreement”) with certain accredited investors for the sale of an aggregate of
Pursuant to the purchase agreement (the “Anson Purchase Agreement”) with Anson Investment Master Fund LP and Anson East Master Fund LP (collectively “Anson”), on January 28, 2025 (the “Third Closing Date”), the Company sold a total of $
On September 30, 2025,
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 $
The Company has secured operating capital that it anticipates as sufficient to fund its drug development operations through at least the second quarter of 2026 and to finance submission of FDA NDAs for NRX-100 and NRX-101. The Company additionally expects to continue to accrue revenue from clinical operations. The Company may pursue additional equity or debt financing or refinancing opportunities in 2025 and 2026 to fund ongoing clinical activities, to meet obligations under its current debt arrangements and for general corporate purposes. Such arrangements may take the form of loans, equity offerings, strategic agreements, licensing agreements, joint ventures, or other agreements. The sale of equity could result in additional dilution to the Company’s existing stockholders. The Company cannot make any assurances that additional financing will be available to it and, if available, on acceptable terms, or that it will be able to refinance its existing debt obligations which could negatively impact the Company’s business and operations and could also lead to a reduction in the Company’s operations. The Company will continue to carefully monitor the impact of its continuing operations on the Company’s working capital needs and debt repayment obligations. As such, the Company has concluded that substantial doubt exists regarding the Company’s ability to continue as a going concern for a period of at least twelve months from the date of issuance of these condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the company be unable to continue as a going concern.
Note 3. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the condensed consolidated balance sheet, statements of operations and cash flows for the interim periods presented. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period.
The condensed consolidated financial statements include the accounts of NRx Pharmaceuticals, Inc. and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.
Use of Estimates
The preparation of condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in its condensed consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s condensed consolidated financial statements relate to the allowance for credit losses on accounts receivable, fair value of the convertible notes payable, fair value of warrant liabilities, fair value of stock options and warrants, fair value of the Common Stock shares granted for services, fair value of the purchase price and the assets acquired and liabilities assumed in business combinations, the fair value of intangible assets and goodwill, the fair value of lease liabilities and related right of use assets, and the utilization of deferred tax assets. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Certain Risks and Uncertainties
The Company’s activities are subject to significant risks and uncertainties, including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
Fair Value of Financial Instruments
FASB ASC Topic 820, Fair Value Measurements (“ASC 820”), provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes:
Level 1: Quoted prices in active markets for identical assets or liabilities.
Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. (Refer to Note 14)
Business Acquisition
The Company recognizes and measures identifiable tangible and intangible assets acquired and liabilities assumed as of the acquisition date at fair value. Fair value measurements require extensive use of estimates and assumptions, including estimates of future cash flows to be generated by the acquired assets. The operating results of the acquired business are included in our unaudited condensed consolidated financial statements beginning on the date of acquisition. The purchase price is equivalent to the fair value of consideration transferred. Goodwill is recognized for the excess of purchase price over the net fair value of assets acquired and liabilities assumed. Acquisition-related costs are expensed as incurred.
Concentration of Credit Risk and Off-Balance Sheet Risk
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Cash equivalents are occasionally invested in certificates of deposit. The Company maintains each of its cash balances with high-quality and accredited financial institutions and accordingly, such funds are not exposed to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Deposits in financial institutions may, from time to time, exceed federally insured limits. As of September 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 $
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to be cash equivalents, including balances held in the Company’s money market accounts. The Company maintains its cash and cash equivalents with financial institutions, in which balances from time to time may exceed the U.S. federally insured limits. The objectives of the Company’s cash management policy are to safeguard and preserve funds to maintain liquidity sufficient to meet the Company’s cash flow requirements, and to attain a market rate of return.
Allowance for credit losses
Accounts receivable are recorded at the estimated transaction price (net of contractual adjustments, discounts, and implicit price concessions). The Company applies the Current Expected Credit Loss (“CECL”) model to estimate lifetime expected credit losses on trade receivables and contract assets, pooling receivables by payer type and aging and incorporating historical loss experience, current conditions, and reasonable‑and‑supportable forecasts with reversion to historical loss information beyond the forecast horizon. Receivables are written off when collection is deemed remote; recoveries are recognized when received. The Company does have any off-balance sheet credit exposure related to its customers.
As part of the acquisition of Dura on September 8, 2025, accounts receivable were recorded at fair value, which reflected expected collectability (see Note 17 Business Combinations). Post-acquisition, the Company continues to apply the CECL model to estimate expected credit losses. The allowance for credit losses was $
Intangible Assets
The Company’s intangible assets consist of customer relationships, trade name, and non-compete agreements. Customer relationships represents the value of established patient relationships and referral sources that are expected to generate recurring revenue streams. Trade name represents the value associated with the brand name in place at the date of the acquisition. Non-compete intangible assets represent the value associated with non-compete agreements for former employees and owners in place at the date of the acquisition. The customer relationships and trade name are being amortized over a -year term and -year term, respectively, based on the estimated economic useful life of the customer relationships and trademark. The non-compete agreement is amortized over a -year term based on the estimated useful life of the asset. The amortization of the intangible asset is computed using the straight-line method.
The Company evaluates its definite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. Such indicators may include adverse changes in market conditions, legal or regulatory developments, or underperformance relative to expectations. If indicators are present, the Company performs a recoverability test by comparing the asset’s carrying amount to the undiscounted future cash flows expected to result from its use and eventual disposition. If the carrying amount is not recoverable, an impairment loss is recognized for the excess of the carrying amount over the asset’s fair value.
Goodwill
Goodwill represents the excess of the cost of an acquired business over the fair value assigned to its net assets. Goodwill is not amortized but is tested for impairment at a reporting unit level on an annual basis or when an event occurs, or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying amount. Events or changes in circumstances that may trigger interim impairment reviews include, but not limited to, significant adverse changes in business climate, operating results, planned investments in the reporting unit, or an expectation that the carrying amount may not be recoverable, among other factors.
The Company may first assess qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If, after assessing the totality of events and circumstances, the Company determines it is more likely than not that the fair value of the reporting unit is greater than its carrying amount, an impairment test is unnecessary. If an impairment test is necessary, the Company will estimate the fair value of its related reporting units. If the carrying value of a reporting unit exceeds its fair value, the goodwill of that reporting unit is determined to be impaired, and the Company will proceed with recording an impairment charge equal to the excess of the carrying value over the related fair value.
During the nine months ended September 30, 2025, the Company recorded goodwill in connection with a business acquisition. In evaluating whether a triggering event occurred during the period, the Company performed a qualitative assessment consistent with the guidance in U.S. GAAP. This assessment considered the totality of events and circumstances, including the existence of substantial doubt to continue as a going concern, and concluded that it is not more likely than not (i.e., less than a 50% likelihood) that the fair value of the reporting unit is below its carrying amount. Based on this assessment,
Furniture and Equipment, net
Furniture and equipment, net is stated at cost less accumulated depreciation. These assets are depreciated over their estimated useful lives of to years using the straight-line method.
The Company adheres to ASC 360 Property, Plant, and Equipment and periodically evaluates whether current facts or circumstances indicate that the carrying value of its depreciable assets to be held and used may not be recoverable. If such circumstances are determined to exist, an estimate of undiscounted future cash flows produced by the long-lived assets, or the appropriate grouping of assets, is compared to the carrying value to determine whether impairment exists. If an asset is determined to be impaired, the loss is measured based on the difference between the asset’s fair value and its carrying value. For long-lived assets, the estimate of fair value is based on various valuation techniques, including a discounted value of estimated future cash flows. The Company reports an asset to be disposed of at the lower of its carrying value or its fair value less costs to sell. There were
Revenue Recognition
The Company accounts for revenue under FASB ASC Topic 606, Revenue for Contract with Customers (“ASC 606”) or other accounting standards for revenue not derived from customers. Arrangements may include licenses to intellectual property, research services, and participation on joint research committees. The Company evaluates the promised goods or services to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, the Company considers the stage of research, the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property, and whether the promised goods or services are integral to or dependent on other promises in the contract. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, timelines, and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract.
The Company enters into contractual arrangements that may include licenses to intellectual property and research and development services. When such contractual arrangements are determined to be accounted for in accordance with ASC 606, the Company evaluates the promised good or services to determine which promises, or group of promises, represent performance obligations. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, timelines, and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract.
The License Agreement (the “License Agreement”) with Alvogen Pharma US, Inc., Alvogen, Inc., and Lotus Pharmaceutical Co. Ltd. (collectively, “Alvogen”) (as further discussed in Note 9 below) was accounted for in accordance with ASC 606. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps:
| i. | identify the contract(s) with a customer; | |
| ii. | identify the performance obligations in the contract; | |
| iii. | determine the transaction price; | |
| iv. | allocate the transaction price to the performance obligations within the contract; and | |
| v. | recognize revenue when (or as) the entity satisfies a performance obligation. |
The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract to determine whether each promised good or service is a performance obligation. The promised goods or services in the Company’s arrangements typically consist of a license to intellectual property and research services. The Company may provide options to additional items in such arrangements, which are accounted for as separate contracts when the customer elects to exercise such options, unless the option provides a material right to the customer. Performance obligations are promises in a contract to transfer a distinct good or service to the customer that (i) the customer can benefit from on its own or together with other readily available resources, and (ii) is separately identifiable from other promises in the contract. Goods or services that are not individually distinct performance obligations are combined with other promised goods or services until such combined group of promises meet the requirements of a performance obligation.
The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable, or a combination of both. At contract inception for arrangements that include variable consideration, the Company estimates the probability and extent of consideration it expects to receive under the contract utilizing either the most likely amount method or expected amount method, whichever best estimates the amount expected to be received. The Company then considers any constraints on the variable consideration and includes in the transaction price variable consideration to the extent it is deemed probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
The Company then allocates the transaction price to each performance obligation based on the relative standalone selling price and recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress for each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
The Company records amounts as accounts receivable when the right to consideration is deemed unconditional. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded as deferred revenue.
The Company’s revenue arrangements may include the following:
Milestone Payments: At the inception of an agreement that includes milestone payments, the Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty.) The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Research Services: The Company incurred research costs in association with the License Agreement. After the First Milestone Payment (as defined in Note 9 below), the Company would have been reimbursed for certain costs incurred related to reasonable and documented out-of-pocket costs for clinical and non-clinical development activities. The Company would have recognized revenue for the reimbursed costs when the First Milestone Payment contingencies had been achieved, and the Company had an enforceable claim to the reimbursed costs.
Patient Service Revenue: Patient service revenue is recognized as performance obligations are satisfied, which occurs over time as patients simultaneously receive and consume services. Each treatment or visit generally represents a separate contract. Procedural services (e.g., ketamine infusions, esketamine administration, TMS sessions, SGB/epidural procedures) are recognized at the point in time when rendered; therapy and medication management services are recognized as sessions occur. The transaction price includes variable consideration such as contractual adjustments, expected denials, and implicit price concessions, which are estimated and constrained to amounts not expected to reverse. The Company applies the portfolio approach for contracts with similar characteristics by payer and service type. The Company elected the practical expedient not to assess a significant financing component because the period between service and payment is one year or less. The Company acts as principal in its patient service arrangements and records revenue on a gross basis.
Patient service revenue is primarily derived from services rendered to patients for outpatient behavioral health care, interventional psychiatry, and pain management procedures. The Company’s services have no fixed duration and can generally be terminated by the patient or the Company at any time; therefore, each treatment or visit is considered its own stand-alone contract.
The Company disaggregates Patient service revenue from contracts with customers by service type including procedural services and therapy services and by payor type including commercial insurance, Medicare, and self-pay. Management believes this presentation best reflects the nature, amount, timing, and uncertainty of the Company’s patient service revenue and cash flows.
Cost of Patient Services
Cost of patient services includes direct costs associated with providing healthcare services, such as salaries and benefits for clinical personnel, medical supplies, pharmaceuticals, and other costs directly attributable to patient care. These costs are expensed as incurred.
Research and Development Costs
Research and development expense consists primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in ongoing research and development efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are recorded as prepaid assets and expensed when the activity has been performed or when the goods have been received.
Non-cancellable Contracts
The Company may record certain obligations as liabilities related to non-cancellable contracts. If appropriate, the offsetting costs may be recorded as a deferred cost asset.
Convertible Notes Payable and Fair Value Election
As permitted under FASB ASC Topic 825, Financial Instruments (“ASC 825”), the Company elected to account for its promissory notes, which meet the required criteria, at fair value at inception. Subsequent changes in fair value including interest and amortization of discounts are recorded as a component the change in fair value of convertible notes payable included in other expense (income) in the condensed consolidated statements of operations. The portion of total changes in fair value of the notes attributable to changes in instrument-specific credit risk are determined through specific measurement of periodic changes in the discount rate assumption exclusive of base market changes and are presented as a component of comprehensive income in the accompanying condensed consolidated statements of operations and comprehensive loss. As a result of electing the fair value option, direct costs and fees related to the issuance of the promissory notes are expensed as incurred.
The Company estimates the fair value of its notes payable using a Monte Carlo simulation model, which uses as inputs the fair value of its Common Stock and estimates for the equity volatility of its Common Stock, the time to expiration (i.e., expected term) of the note, the risk-free interest rate for a period that approximates the time to expiration, and probability of default. Therefore, the Company estimates its expected future equity volatility based on the historical volatility of its Common Stock price utilizing a lookback period consistent with the time to expiration. The time to expiration is based on the contractual maturity date, giving consideration to the redemption features embedded in the notes. The risk-free interest rate is determined based on the U.S. Treasury yield curve in effect at the time of measurement for time periods approximately equal to the time to expiration. Unless otherwise specified, the probability of default is estimated using Bloomberg’s Default Risk function which uses its financial information to calculate a default risk specific to the Company. Management believes those assumptions are reasonable but if these assumptions change, it could materially affect the fair value.
Stock-Based Compensation
The Company expenses stock-based compensation to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards. The Company accounts for forfeitures as they occur. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. The Company estimates the fair value of restricted stock award grants using the closing trading price of the Company’s Common Stock on the date of issuance. All stock-based compensation costs are recorded in general and administrative or research and development costs in the condensed consolidated statements of operations and comprehensive loss based upon the underlying individual’s role at the Company.
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”) and FASB ASC Topic 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own Common Stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The Company generally determines fair value of the Common Stock Warrants using a Black-Scholes valuation methodology.
A change in any of the terms or conditions of warrants is accounted for as a modification. The accounting for incremental fair value of warrants is based on the specific facts and circumstances related to the modification which may result in a reduction of additional paid-in capital, recognition of costs for services rendered, or recognized as a deemed dividend.
Preferred Stock
In accordance with ASC 480, the Company’s Series A preferred stock was classified as permanent equity as it was not mandatorily redeemable upon an event that is considered outside of the Company’s control. Further, in accordance with ASC 815-40, Derivatives and Hedging – Contracts in an Entity’s Own Equity, the Series A preferred stock did not meet any of the criteria that would preclude equity classification. The Company concluded that the Series A preferred stock was more akin to an equity-type instrument than a debt-type instrument, therefore the conversion features associated with the convertible preferred stock were deemed to be clearly and closely related to the host instrument and were not bifurcated as a derivative under ASC 815.
Segment Information
The Company’s Chief Operating Decision Maker (“CODM”) is its Chief Executive Officer, who reviews financial information presented for purposes of making operating decisions, assessing financial performance, and allocating resources. The Company operates as a single operating and reportable segment, consistent with the manner in which the CODM evaluates performance and allocates resources, see Note 15 for further information.
Income Taxes
Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes any interest and penalties accrued related to unrecognized tax benefits as income tax expense.
Loss Per Share
The Company applies the two-class method when computing net income or loss per share attributable to Common Stockholders. In determining net income or loss attributable to Common Stockholders, the two-class method requires income or loss allocable to participating securities for the period to be allocated between common and participating securities based on their respective rights to share in the earnings as if all of the income or loss allocable for the period had been distributed. In periods of net loss, there is no allocation required under the two-class method as the participating securities do not have an obligation to fund the losses of the Company.
Basic loss per share of Common Stock is computed by dividing net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding for the period. Diluted loss per share reflects the potential dilution that could occur if stock options, restricted stock awards and warrants were to vest and be exercised. Diluted earnings per share excludes, when applicable, the potential impact of stock options, Common Stock warrant shares, convertible notes, and other dilutive instruments because their effect would be anti-dilutive in the periods in which the Company incurs a net loss.
The following outstanding shares of Common Stock equivalents were excluded from the computation of the diluted net loss per share attributable to Common Stock for the periods in which a net loss is presented because their effect would have been anti-dilutive.
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| Stock options | ||||||||
| Restricted stock awards | ||||||||
| Common Stock warrants | ||||||||
| Common Stock issuable upon conversion of Anson Notes | ||||||||
| Totals | ||||||||
Recent Accounting Pronouncements Not Yet Adopted
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are adopted by the Company as of the specified effective date.
In December 2023, the FASB issued ASU 2023-09-Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which is intended to enhance the transparency and decision usefulness of income tax disclosures, primarily by amending disclosure requirements for the effective tax rate reconciliation and income taxes paid. ASU 2023-09 should be applied on a prospective basis, and retrospective application is permitted. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the presentational impact of this ASU and expects to adopt its provisions in the Annual Report on Form 10-K for the year ending December 31, 2025.
In November 2024, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”) and in January 2025, the FASB issued ASU No. 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date, which clarified the effective date of ASU 2024-03. ASU 2024-03 will require the Company to disclose the amounts of purchases of inventory, employee compensation, depreciation, and intangible asset amortization, as applicable, included in certain expense captions in the Consolidated Statements of Operations, as well as qualitatively describe remaining amounts included in those captions. ASU 2024-03 will also require the Company to disclose both the amount and the Company’s definition of selling expenses. The Company will adopt ASU 2024-03 in its annual report for the year ended December 31, 2026.
In May 2025, the FASB issued ASU No. 2025-03, Business Combinations (Topic 805) and Consolidation (Topic 810): Determining the Accounting Acquirer in the Acquisition of a Variable Interest Entity (“VIE”), which provides clarifying guidance on determining the accounting acquirer in certain transactions involving VIEs. The update aims to improve consistency and comparability in financial reporting. The guidance will be effective for annual periods beginning after December 15, 2026, including interim periods within those annual periods. Early adoption is permitted. Upon adoption, the guidance will be applied prospectively. The Company is currently evaluating the provisions of the amendments and the impact on its future financial statements.
In July 2025, the FASB issued ASU 2025-05, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets. This standard provides all entities with a practical expedient to assume that current conditions as of the balance sheet date do not change for the remaining life of the current accounts receivable and current contract assets. ASU 2025-05 is effective for fiscal years beginning after December 15, 2025 and interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2025-05.
In September 2025, the FASB issued ASU 2025-06, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software, to modernize the accounting guidance for internal-use software costs. The standard removes all references to software development project stages and instead requires capitalization when (i) management has authorized and committed to funding the software project and (ii) it is probable that the project will be completed and the software will be used to perform the function intended. ASU 2025-06 is effective for fiscal years beginning after December 15, 2027 and interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2025-06.
Note 4. Revenue and accounts receivable
Revenue for the three and nine months ended September 30, 2025 is primarily derived from services rendered to patients for outpatient behavioral health care, interventional psychiatry, and pain management procedures. The Company’s services have no fixed duration and can generally be terminated by the patient or the Company at any time; therefore, each treatment or visit is considered its own stand-alone contract.
The Company disaggregates revenue from contracts with customers by service type and by payor, as management believes this best depicts the nature, amount, timing, and uncertainty of revenue and cash flows.
Revenue by Service Type (in thousands):
| Three Months Ended September 30, 2025 |
Nine Months Ended September 30, 2025 |
|||||||
| Procedures income |
$ | $ | ||||||
| Therapy services |
||||||||
| Total net patient service revenue |
$ | $ | ||||||
Revenue by payor (in thousands):
| Three Months Ended September 30, 2025 |
Nine Months Ended September 30, 2025 |
|||||||
| Commercial Insurance |
$ | $ | ||||||
| Medicare |
||||||||
| Self-Pay |
||||||||
| Total net patient service revenue |
$ | $ | ||||||
The Company receives payments from the following sources: (i) commercial insurers; (ii) the federal government under the Medicare program administered by the Centers for Medicare and Medicaid Services (“CMS”) and other programs; (iii) state governments under Medicaid and related programs; and (iv) individual patients and clients.
The Company determines the transaction price based on established billing rates reduced by contractual adjustments, discounts, and implicit price concessions, which represent amounts the Company does not expect to collect based on historical experience and other relevant factors. Contractual adjustments and discounts are based on contractual agreements with commercial insurance and Medicare, discount policies, and historical experience. Implicit price concessions are based on historical collection experience. Most of the Company’s services have contracts containing variable considerations, such as contractual adjustments, discounts, and implicit price concessions, which are estimated and reflected as reductions to revenue in the period the services are provided. However, it is unlikely a significant reversal of revenue will occur when the uncertainty is resolved, and therefore, the Company includes the variable consideration in the estimated transaction price. Subsequent changes resulting from a patient’s ability to pay are recorded as credit loss expense, which is included in other operating expenses. For the nine months ended September 30, 2025, current expected credit loss recovery was less than $
The Company derives a significant portion of its revenue from Medicare, and other payors that receive discounts from established billing rates. The Medicare regulations and various managed care contracts under which these discounts must be estimated are complex, subject to interpretation and adjustment, and may include multiple reimbursement mechanisms for different types of services provided. Management estimates the transaction price on a payor specific basis given its interpretation of the applicable regulations or contract terms. The services authorized and provided and related reimbursement are often subject to interpretation that could result in payments that differ from the Company’s estimates.
Accounts Receivable and allowance for credit loss
Accounts Receivable (in thousands):
| September 30, 2025 |
||||
| Accounts receivable, gross |
$ | |||
| Less: allowance for credit losses |
( |
) | ||
| Accounts receivable, net |
$ | |||
Allowance for credit losses roll-forward (in thousands):
| Beginning balance as of December 31, 2024 |
$ | |||
| Acquisition of Dura (September 8, 2025) |
||||
| Provision (recovery) for expected credit losses |
( |
) | ||
| Write-offs, net of recoveries |
||||
| Ending Balance as of September 30, 2025 |
$ |
Accounts Receivable by payor (in thousands):
| September 30, 2025 |
||||
| Commercial insurance |
$ | |||
| Medicare |
||||
| Self-pay |
||||
| Accounts receivable, gross |
$ | |||
Estimation inputs and credit quality information (summary):
| ● |
Receivables are pooled by payer class and aging; loss rates reflect historical experience updated for current conditions and reasonable‑and‑supportable forecasts with reversion to long‑run averages beyond the forecast horizon. The Company does not suspend recognition of revenue on a “nonaccrual” basis for trade receivables. |
Note 5. Prepaid Expense and Other Current Assets
Prepaid expense and other current assets consisted of the following at the dates indicated (in thousands):
| September 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| Prepaid expense and other current assets: | ||||||||
| Prepaid insurance | $ | $ | ||||||
| Prepaid clinical development costs | ||||||||
| Other prepaid expense | ||||||||
| Total prepaid expense and other current assets | $ | $ | ||||||
Note 6. Furniture and equipment, net
As of September 30, 2025, furniture and equipment, net, consisted of the following (in thousands):
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Medical equipment | $ | $ | ||||||
| Computer equipment | ||||||||
| Furniture and fixtures | ||||||||
| Total furniture and equipment | ||||||||
| Less: accumulated depreciation | ( | ) | ( | ) | ||||
| Furniture and equipment, net | $ | $ | ||||||
Depreciation expense was $
Note 7. Leases
Accounting for Leases as Lessee
The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use assets (“ROU”), lease liabilities, and lease liabilities – related party. Lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. None of the leases entered into have an implicit rate, the Company uses its incremental borrowing rate based on the information available at lease commencement date in determining the present value of future payments. Incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in economic environments where the leased asset is located. The ROU assets also include any prepaid lease payments made and initial direct costs incurred and exclude lease incentives. The Company’s lease terms may include options to extend or terminate the lease, which is recognized when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Leases with an initial term of 12 months or less are not recorded on the balance sheet.
The Company has operating leases for
| ● | Naples Lease (Related Party): The Company leases its Naples clinic from Dura Properties, LLC, an entity owned and controlled by Dura’s former sole member prior to the acquisition. Following the acquisition on September 8, 2025, the former member became a director and minority shareholder of the Company. Right-of-use (ROU) assets and operating lease liabilities was measured under ASC 805 as if the leases were new at the acquisition date. The amended lease commenced on September 8, 2025 and expires on December 31, 2027. It is non-cancelable and requires monthly base rent of $ |
| ● | Fort Myers Lease (Third Party): The Company amended a lease for its Fort Myers clinic on September 8, 2025, with a commencement date of September 8, 2025, and an expiration date of November 30, 2026. Right-of-use (ROU) assets and operating lease liabilities was measured under ASC 805 as if the leases were new at the acquisition date. The amended lease is non-cancellable and requires monthly base rent of $ |
The components of lease expense included in the Company’s statement of operations were as follows (in thousands):
| For the three months ended | For the nine months ended | ||||||||
| September 30, | September 30, | ||||||||
| Expense Classification | 2025 | 2025 | |||||||
| Operating lease expense: | |||||||||
| Amortization of ROU asset | Selling, general and administrative | $ | $ | ||||||
| Accretion of operating lease liability | Selling, general and administrative | ||||||||
| Amortization of ROU asset - related party | Selling, general and administrative | ||||||||
| Accretion of operating lease liability - related party | Selling, general and administrative | ||||||||
| Total operating lease expense | $ | $ | |||||||
| Other lease expense | Selling, general and administrative | ||||||||
| Total | $ | $ | |||||||
Other information related to leases is as follows:
| As of September 30, | ||||
| 2025 | ||||
| Weighted-average remaining lease term: | ||||
| Operating leases (in years) | ||||
| Weighted-average discount rate: | ||||
| Operating leases | % | |||
Amounts relating to leases were presented on the balance sheet as of September 30, 2025 in the following line items (in thousands):
| As of September 30, | |||||
| Balance Sheet Classification | 2025 | ||||
| Assets: | |||||
| Operating lease asset | Right-of-use asset | $ | |||
| Operating lease asset - related party | Right-of-use asset - related party | ||||
| Total non-current lease assets | $ | ||||
| Liabilities: | |||||
| Current | |||||
| Operating lease liability | Lease liability, short term | $ | |||
| Operating lease liability - related party | Lease liability, short term - related party | ||||
| Non-current | |||||
| Operating lease liability | Lease liability, non-current | ||||
| Operating lease liability - related party | Lease liability - related party, non-current | ||||
| Total lease liabilities | $ | ||||
The future minimum lease payments required under leases as of September 30, 2025 were as follows (in thousands):
| Fiscal Year | ||||
| Remainder of 2025 | $ | |||
| 2026 | ||||
| 2027 | ||||
| Total | ||||
| Less: imputed interest | ( | ) | ||
| Lease liability | $ |
Note 8. Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following at the dates indicated (in thousands):
| September 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| Accrued and other current liabilities: | ||||||||
| Refund liability (see Note 9) | $ | $ | ||||||
| Professional services | ||||||||
| Employee costs | ||||||||
| Accrued research and development expense | ||||||||
| Accrued Dura acquisition cost due post-closing | ||||||||
| Other accrued expense | ||||||||
| Total accrued and other current liabilities | $ | $ | ||||||
Note 9. Alvogen Licensing Agreement
In June 2023, the Company entered into a License Agreement with Alvogen. On June 21, 2024, the Company received a notice of termination from Alvogen effective immediately. Following the termination of the License Agreement by Alvogen, the amounts advanced pursuant to the amendment became due and payable to Alvogen. Accordingly, the refund liability has not been reclassified to deferred revenue or recorded as revenue as of September 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 September 30, 2025, the refund liability due to Alvogen was $
Note 10. Debt
Streeterville Convertible Note
On November 4, 2022, the Company issued a convertible note to Streeterville Capital, LLC (“Streeterville”), for an aggregate principal amount of $
The Company evaluated the terms of the Settlement Agreement in accordance with ASC 470-50, Debt Modifications and Extinguishments. Both the Settlement Amendment and the Third Amendment (considered cumulatively with the Settlement Amendment) were deemed to be debt modifications and did not give rise to a debt extinguishment in accordance with ASC Topic 470, Debt, which will be accounted for prospectively. 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 September 30, 2025 and December 31, 2024, the Streeterville Note carried a remaining principal balance of $
Anson Convertible Promissory Notes (the “Anson Notes”)
On August 12, 2024, the Company entered into the Anson Purchase Agreement with the Investors, Anson Investment Master Fund LP and Anson East Master Fund LP (collectively “Anson”). The Company agreed to sell, in
In connection with the above offering, the Company engaged EF Hutton LLC as placement agent. Pursuant to the terms of the engagement with the placement agent, the Company paid a cash fee of
On August 14, 2024, the Company entered into the first tranche Senior Secured Convertible Note Agreements (the “First Tranche Notes”) with Anson at various amounts for an aggregate of $
On August 14, 2024, in conjunction with the issuance of the First Tranche Notes, the Company issued warrants to purchase up to
The First Tranche Notes are convertible at the option of the holder at any time after issuance into Common Stock, at a per share conversion price equal to the lower of (a) $
The terms of the First Tranche Notes do not allow any conversion of the First Tranche Notes if it results in Anson owning more than 4.99% of the outstanding shares of Common Stock (the “Beneficial Ownership Limitation”). This limitation can be adjusted up to 9.99% with prior notice, effective 61 days after such notice. Anson must ensure compliance with this limitation when submitting a notice of conversion, and the Company will rely on Anson's representation of compliance.
If the Company issues or grants options for Common Stock at a price lower than the current Conversion Price, the Conversion Price will be adjusted to match this lower price, (the “Base Conversion Price”). The Company must notify Anson of any such issuance, and Anson is entitled to convert shares based on the new Base Conversion Price.
If the Company offers purchase rights to holders of Common Stock, Anson will be entitled to acquire those rights as if they had fully converted the Note, subject to the Beneficial Ownership Limitation. If exercising these rights would exceed the Beneficial Ownership Limitation, the rights will be held in abeyance until they can be exercised without exceeding the limit.
The First Tranche Notes contain mandatory redemption features, whereby if at any time the First Tranche Notes are outstanding, the Company will be required to: (A) use up to 30% of the gross proceeds from any Subsequent Financings (as defined in the Anson Purchase Agreement) in cash, to redeem all or a portion of the Note for an amount equal to the outstanding principal, plus all accrued but unpaid interest, plus all liquidated damages (the “Redemption Obligations”), multiplied by 1.05 (the “Mandatory Redemption Amount”); (B) redeem all of the Redemption Obligations at the Mandatory Redemption Amount in the event of a Change of Control Transaction (as defined in the First Tranche Notes); (C) redeem the Redemption Obligations for the Mandatory Redemption Amount in the event a registration statement is not available for each of the offer and resale of the shares issuable upon conversion of the First Tranche Notes (the “Conversion Shares”); and (D) redeem the Redemption Obligations for the Mandatory Redemption Amount if the stockholder approval is not obtained within 180 days following the date of issuance of the First Tranche Notes.
The First Tranche Notes contain certain covenants, and events of default and triggering events, respectively, which would require repayment of the obligations outstanding pursuant to such instruments. The obligations of the Company pursuant to the First Tranche Notes are (i) secured by all assets of the Company and all subsidiaries of the Company pursuant to the Security Agreement and Patent Security Agreement, dated August 14, 2024, by and among the Company, the subsidiaries of the Company, and the Investors, and (ii) guaranteed jointly and severally by the subsidiaries of the Company pursuant to the Subsidiary Guarantee, dated August 14, 2024, by and among the Company, the subsidiaries of the Company, and the Investors.
Pursuant to the Anson Purchase Agreement, on October 10, 2024 (the “Second Closing Date”), the Company sold a total of $
In connection with the above Second Tranche Notes, the Company engaged a placement agent. Pursuant to the terms of the engagement with the Placement Agent, the Company paid a cash fee of
Pursuant to the Anson Purchase Agreement, on January 28, 2025 (the “Third Closing Date”), the Company sold a total of $
In connection with the above Third Tranche Notes, the Company paid a cash tail fee to the Placement Agent equal to
On or about January 27, 2025, the Company and the Investors entered into a Consent and Waiver Agreement (the “CWA”), relating to certain rights and prohibitions arising under the Anson Purchase Agreement and the Notes. In the CWA, each of the Investors provided its consent under certain restrictive provisions, and waived certain rights, including, among other things, a right to participate in certain Qualified Financings (as defined in the CWA) made by us under the Anson Purchase Agreement and the Notes, the prohibition on issuance of certain equity securities, and waiver of any potential liquidated damages arising under that certain Registration Rights Agreement by and between the Company and the Investors dated August 14, 2024, until March 31, 2025. On March 20, 2025, following the conversion of less than $
Due to these embedded features within the Anson Notes, the Company elected to account for the First, Second, and Third Tranche Notes at fair value at inception. Subsequent changes in fair value are recorded as a component of other income (loss) in the condensed consolidated statements of operations. Additionally, the portion of changes in the fair value related to changes in credit risk are recorded to other comprehensive income in the condensed consolidated statements of operations. To determine the initial carrying value of the Notes and the warrants issued to Anson under the First, Second, and Third Tranche Notes (see Note 12), the Company allocated the proceeds using the fair value method. After allocation, the initial carrying value of the First Tranche Notes and the warrants issued to Anson were $
In connection with the Second RD Purchase Agreement, and pursuant to the full ratchet anti-dilution provisions contained in the Anson financing agreements, the Fixed Conversion Price component of the variable conversion formula of the outstanding Anson Notes, and the exercise price of all outstanding Common Stock purchase warrants issued on August 14, 2024, October 10, 2024, January 28, 2025, and January 29, 2025 (collectively, the “Anson Warrants”) were each adjusted to $
The holders of Anson Notes and Anson Warrants, in accordance with an agreement entered into with Anson on September 30, 2025, agreed to, among other things, i) certain trading volume limitations, and ii) a partial exercise on previously issued Anson Warrants for cash. Specifically, if the closing stock price of the Company’s common stock as reported on the Principal Market (as defined in the August 2024 Purchase Agreement) is below $
During the three months ended March 31, 2025, Anson converted $
During the year ended December 31, 2024, Anson converted $
Note 11. Commitments and Contingencies
Sarah Herzog Memorial Hospital License Agreement
The Company is required to make certain payments related to the development of NRX-101 (the “Licensed Product”) in order to maintain the license agreement with the Sarah Herzog Memorial Hospital Ezrat Nashim (“SHMH”) (the “SHMH License Agreement”), including:
Milestone Payments
| End of Phase I Clinical Trials of Licensed Product (completed) | $ | |||
| End of Phase II Clinical Trials of Licensed Product (completed) | $ | |||
| End of Phase III Clinical Trials of Licensed Product | $ | |||
| First Commercial Sale of Licensed Product in U.S. | $ | |||
| First Commercial Sale of Licensed Product in Europe | $ | |||
| Annual Revenues Reach $100,000,000 | $ |
The milestone payments due above may be reduced by
Royalties
A royalty in an amount equal to: (a)
Royalties shall also apply to any revenues generated by sub-licensees from sale of Licensed Products subject to a cap of
Annual Maintenance Fee
A fixed amount of $
Exclusive License Agreement
The Company has entered into a license agreement with Apkarian Technologies LLC to in-license US patent 8,653,120 that claims the use of D-cycloserine for the treatment of chronic pain in exchange for a commitment to pay milestones and royalties as development milestones are reached in the field of chronic pain. The patent is supported by extensive nonclinical data and early clinical data that suggest the potential for NMDA antagonist drugs, such as NRX-101 to decrease both chronic pain and neuropathic pain while potentially decreasing craving for opioids. For the three and nine months ended September 30, 2025 and 2024, the Company has recorded
Kadima Purchase Agreement
On May 9, 2025, in furtherance of the Company’s previously announced plans for its subsidiary, HOPE, to develop a national network of precision psychiatry clinics. HOPE and its wholly-owned subsidiary, HTX, entered into an Asset Purchase and Contribution Agreement (the “Kadima Purchase Agreement”), with Kadima Medical, Kadima Holdings, Inc. (“Kadima Holdings”), and David Feifel, M.D., PH.D (“Feifel”, and collectively with Kadima Medical and Kadima Holdings, “Kadima”), pursuant to which the Company agreed to purchase and Kadima agreed to sell, certain assets of Kadima, subject to the satisfaction of certain closing conditions (the “Acquisition”).
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 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.
As of the date of this Report, the parties have not closed the Acquisition and the matter has entered arbitration. At this stage of the arbitration, it is too early to determine if the matter would reasonably be expected to have a material adverse effect on our financial condition.
Operating Lease
The Company leases its office space on a month-to-month basis. The rent expense for the three and nine months ended September 30, 2025 was less than $
The Company also leases two healthcare clinical facilities located in Naples and Fort Myers, Florida under non-cancelable operating lease agreements. Details regarding lease terms, future minimum lease payments, and right-of-use assets and liabilities are disclosed in Note 7.
Legal Proceedings
The Company is, from time to time, involved in various legal proceedings incidental to the conduct of our business. Historically, the outcome of nearly all such legal proceedings 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, pursuant to which the Company agreed to purchase, and Kadima agreed to sell, certain assets of Kadima, subject to the satisfaction of certain closing conditions. As of the date of this Report, the parties have not closed the Acquisition, and the matter has entered arbitration. At this stage of the arbitration, it is too early to determine if the matter would reasonably be expected to have a material adverse effect on our financial condition.
Note 12. Equity
Preferred Stock
Pursuant to the terms of the Company’s Second Amended and Restated Certificate of Incorporation, the Company has shares of preferred stock authorized with a par value of $
Common Stock
Pursuant to the terms of the Company’s Second Amended and Restated Certificate of Incorporation, the Company has authorized
On January 2, 2024, the Company issued
From February 20, 2024 to July 29, 2024, the Company announced that it entered into multiple at-the-market purchase agreements (the “ATM Purchase Agreements”) subject to standard closing conditions where accredited investors purchased
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
On February 29, 2024, the Company entered into a securities purchase agreement with an investor providing for the issuance and sale of
On April 18, 2024, the Company entered into an underwriting agreement (the “April Underwriting Agreement”) with the Representative, as the representative of the several underwriters named therein (the “April Underwriters”), relating to an underwritten public offering (the “April 2024 Public Offering”) of
On August 28, 2024, the Company issued
During the year ended December 31, 2024, Anson converted $
On January 27, 2025, the Company entered into a securities purchase agreement (the “First RD Purchase Agreement”) with Anson for the sale by the Company of
On or around January 27, 2025, the Company and Anson entered into a consent and waiver agreement related to the First RD Purchase Agreement and the Notes. Under this agreement, the investors agreed to waive certain rights and restrictions, including their right to participate in certain future financings, restrictions on the Company issuing specific equity securities, and any potential liquidated damages under the Registration Rights Agreement dated August 14, 2024. These waivers are effective through and expired as of March 31, 2025.
As consideration for these waivers, the Company agreed to issue additional compensation to the investors if the volume-weighted average price (VWAP) of the Company’s Common Stock is lower than the original purchase price at the time investors submit their first conversion notice for Anson Notes issued in the Second or Third Closing. This compensation includes additional shares of Common Stock (the “Consideration Shares”) and warrants to purchase an equal number of shares (the “Consideration Warrants”). The exercise price of the warrants is based on a VWAP-Based Adjustment, calculated as the greater of (a) the VWAP on the trading day before the conversion notice, or (b)
The gross proceeds to the Company from the offerings were approximately $
During the first quarter of fiscal 2025, Anson converted $
During the first quarter of fiscal 2025, Anson converted less than $
During the second quarter of fiscal 2025, Anson converted $
During the third quarter of fiscal 2025, Anson converted $
On March 20, 2025, following the conversion of less than $
On May 15, 2025, the Company granted
On August 18, 2025, the Company entered into a securities purchase agreement (the “Second RD Purchase Agreement”) with certain accredited investors for the sale of an aggregate of
On July 17, 2025, the Company granted
On September 30, 2025, the
Warrants
Substitute Warrants – Liability
On May 24, 2021, the Company completed the merger (“Merger”) under the Agreement and Plan of Merger dated December 13, 2020, as amended, among the Company (formerly Big Rock Partners Acquisition Corp.), NeuroRx, Inc., and Big Rock Merger Corp., a wholly owned subsidiary of our company. In the transaction, Big Rock Merger Corp. merged with and into NeuroRx, with NeuroRx continuing as the surviving entity. In connection with the Merger in 2021, each warrant to purchase shares of Common Stock of NRx that was outstanding and unexercised immediately prior to the effective time (whether vested or unvested) was assumed by Big Rock Partners Acquisition Corp. (“BRPA”) and converted into a warrant, based on the exchange ratio (of
Assumed Public Warrants – Equity
Prior to the Merger, the Company had
During the three and nine months ended September 30, 2025 and 2024
Assumed Private Placement Warrants – Liabilities
Prior to the Merger, the Company had outstanding
The Company recognized a change in fair value of the Private Placement Warrants for the three and nine months ended September 30, 2025 and 2024 in the accompanying statement of operations. See Note 14 for discussion of the fair value measurement of the Company’s warrant liabilities.
Investor Warrants – Equity
As discussed above, on February 28, 2024, in conjunction with the sale of
On February 28, 2024, the Company issued to the Representative the Underwriter’s Warrant to purchase up to
On March 5, 2024, the Company issued Underwriter’s Warrant to purchase up to
On April 19, 2024, the Company issued to the Representative the April Underwriter Warrant to purchase up to
On May 23, 2024, the Company issued Underwriter’s Warrant to purchase up to
Alvogen Warrants – Equity
In conjunction with the amended Licensing Agreement with Alvogen discussed in Note 9, on February 7, 2024 the Company issued warrants to purchase up to
Anson Warrants – Liability
The Anson Warrants, originally issued in the Anson Purchase Agreement, are recognized as derivative liabilities in accordance with ASC 815. The Company concluded liability classification was appropriate as certain settlement features included in the Anson Warrants are not indexed to the Company's own stock, and therefore preclude equity classification. Accordingly, the Company recognizes the warrant instruments as liabilities at fair value and adjusts the instruments to fair value at each reporting period. The liabilities are subject to re-measurement at each balance sheet date until exercise or expiration, and any change in fair value is recognized in the Company’s condensed consolidated statements of operations. The Anson Warrants are measured at fair value using a Black-Scholes model. Warrant liabilities are classified as current liabilities on the Company's condensed consolidated balance sheets. On August 14, 2024, in conjunction with the issuance of the First Tranche Notes, the Company issued warrants to purchase up to
On October 10, 2024, in conjunction with the issuance of the Second Tranche Notes, the Company issued warrants to purchase up to
On January 28, 2025, in conjunction with the issuance of the Third Tranche Notes, the Company issued warrants to purchase up to
In connection with the Second RD Purchase Agreement, and pursuant to the full ratchet anti-dilution provisions contained in the Anson financing agreements, the exercise price of all outstanding Common Stock purchase warrants issued on August 14, 2024, October 10, 2024, January 28, 2025, and January 29, 2025 (collectively, the “Anson Warrants”) were each adjusted to $
The holders of Anson Notes and Anson Warrants, in accordance with the an agreement entered into with Anson on September 30, 2025, agreed to, among other things, i) certain trading volume limitations, and ii) a partial exercise of previously issued Anson Warrants for cash. Specifically, if the closing stock price of the Company’s common stock as reported on the Principal Market (as defined in the August 2024 Purchase Agreement) is below $3.25 on any trading day, Anson may not sell, dispose of, or otherwise transfer, in the aggregate, more than 12.5% of the composite daily trading volume of the Company’s common stock on that trading day. In accordance with the agreement,
RD Warrants – Liabilities
As discussed above, on January 29, 2025, in conjunction with the issuance of the First RD Shares, the Company issued the First RD Warrants to purchase up to
Consideration Warrants – Liability
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
The measurement of fair value of the Consideration Warrants were determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., share price of $
As of September 30, 2025, the aggregate fair value of all liability classified warrants, which include Substitute Warrants, Assumed Private Placement Warrants, Anson Warrants, First RD Warrants and Consideration Warrants, was $
The following table provides the activity for all warrants for the respective periods.
| Aggregate | ||||||||||||||||
| Weighted | Weighted | Intrinsic | ||||||||||||||
| Average | Average | Value | ||||||||||||||
| Total Warrants | Remaining Term | Exercise Price | (in thousands) | |||||||||||||
| Outstanding as of December 31, 2023 | $ | $ | ||||||||||||||
| Issued | — | |||||||||||||||
| Expired | ( | ) | — | — | — | |||||||||||
| Outstanding as of December 31, 2024 | $ | $ | ||||||||||||||
| Issued | — | |||||||||||||||
| Exercised | ( | ) | — | |||||||||||||
| Expired | ( | ) | — | — | — | |||||||||||
| Outstanding as of September 30, 2025 | $ | $ | ||||||||||||||
Note 13. Stock-Based Compensation
2016 Omnibus Incentive Plan
Prior to the Merger, the Company maintained its 2016 Omnibus Incentive Plan (the “2016 Plan”), under which NeuroRx granted incentive stock options, restricted stock awards, other stock-based awards, or other cash-based awards to employees, directors, and non-employee consultants. The maximum aggregate shares of Common Stock that were subject to awards and issuable under the 2016 Plan was
In connection with the Merger, each option of NeuroRx that was outstanding and unexercised immediately prior to the Effective Time (whether vested or unvested) was assumed by BRPA and converted into an option to acquire an adjusted number of shares of Common Stock at an adjusted exercise price per share, based on the Exchange Ratio (of ).
Upon the closing of the Merger, the outstanding and unexercised NeuroRx stock options became options to purchase an aggregate
2021 Omnibus Incentive Plan
As of September 30, 2025,
Option Awards
The fair value of each employee and non-employee stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company is a public company and has limited company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the limited company-specific historical volatility and implied volatility. The expected term of the Company’s stock options for employees has been determined utilizing the “simplified” method for awards. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve. Expected dividend yield is
On February 7, 2025, the Company issued
On April 9, 2025, the Company issued
The stock options granted during the nine months were valued utilizing the Black-Scholes options pricing model with the following inputs: $
The following table summarizes the Company’s employee and non-employee stock option activity under the 2021 Plan for the following periods:
| Weighted | ||||||||||||||||
| average | ||||||||||||||||
| Weighted | remaining | Aggregate | ||||||||||||||
| average | contractual | intrinsic | ||||||||||||||
| Number of | exercise | life (in | value (in | |||||||||||||
| shares | price | years) | thousands) | |||||||||||||
| Outstanding as of December 31, 2023 | $ | $ | ||||||||||||||
| Options granted | — | — | ||||||||||||||
| Forfeited/Expire | ( | ) | — | — | ||||||||||||
| Outstanding as of December 31, 2024 | ||||||||||||||||
| Options granted | ||||||||||||||||
| Forfeited/Expire | ( | ) | — | — | ||||||||||||
| Outstanding as of September 30, 2025 | ||||||||||||||||
| Options vested and exercisable as of September 30, 2025 | $ | $ | ||||||||||||||
Stock-based compensation expense related to stock options was less than $
At September 30, 2025, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted was $
Restricted Stock Awards
The following table presents the Company’s Restricted Stock Activity:
| Weighted | ||||||||
| Average Grant | ||||||||
| Date Fair | ||||||||
| Awards | Value | |||||||
| Balance as of December 31, 2023 (unvested) | $ | |||||||
| Granted | ||||||||
| Vested | ( | ) | $ | |||||
| Forfeited | ( | ) | $ | |||||
| Balance as of December 31, 2024 (unvested) | ||||||||
| Granted | $ | — | ||||||
| Vested | $ | |||||||
| Forfeited | $ | |||||||
| Balance as of September 30, 2025 (unvested) | ||||||||
On July 12, 2022, the board of directors (the “Board”) granted an award of
On December 28, 2023, the Company granted
Stock-based compensation expense related to RSAs was $
In October 2024, the Company's chief executive officer announced his resignation and as a result, all unvested RSAs were forfeited. Accordingly, the Company does expect to recognize any further stock-based compensation expense for the balance of unvested RSAs as of December 31, 2024.
The following table summarizes the Company’s recognition of stock-based compensation for the following periods (in thousands):
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (Unaudited) | ||||||||||||||||
| Stock-based compensation expense | ||||||||||||||||
| General and administrative | $ | $ | $ | $ | ||||||||||||
| Research and development | ||||||||||||||||
| Total stock-based compensation expense | $ | $ | $ | $ | ||||||||||||
Note 14. Fair Value Measurements
Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the three and nine months ended September 30, 2025 and 2024. The carrying amount of accounts payable approximated fair value as they are short term in nature. The fair value of stock options and warrants issued for services, and warrants issued with the Convertible Notes are estimated based on the Black-Scholes model. The fair value of the convertible notes payable was estimated utilizing a Monte Carlo simulation.
Fair Value on a Recurring Basis
The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually. The estimated fair value of the money market account represents a Level 1 measurement. The estimated fair value of the warrant liabilities and convertible note payable represent Level 3 measurements. The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis at September 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):
| Description | Level | September 30, 2025 | December 31, 2024 | |||||||||
| (Unaudited) | ||||||||||||
| Assets: | ||||||||||||
| Money Market Account | 1 | $ | $ | |||||||||
| Liabilities: | ||||||||||||
| Warrant liabilities (Note 12) | 3 | $ | $ | |||||||||
| Convertible note payable and accrued interest, current (Note 10) | 3 | $ | $ | |||||||||
| Convertible note payable and accrued interest, non-current (Note 10) | 3 | $ | $ | |||||||||
Convertible Note Payable - Anson
The significant inputs used in the Monte Carlo simulation to measure the Anson Note liability that is categorized within Level 3 of the fair value hierarchy are as follows:
| September 30, | ||||
| 2025 | ||||
| Stock price on valuation date | $ | 3.30 | ||
| Conversion price | $ | |||
| Time to expiration | ||||
| Cost of debt | 15.50 | % | ||
| Equity volatility | % | |||
| Risk-free rate | 3.83 | % | ||
| Probability of credit default prior to maturity | 1 | % | ||
The following table sets forth a summary of the changes in the fair value of the Anson Note categorized within Level 3 of the fair value hierarchy (in thousands):
| Fair value of Anson Notes as of December 31, 2024 | $ | |||
| Fair value of Anson III Note at issuance | ||||
| Conversion and repayments of principal and interest (shares) | ( | ) | ||
| Fair value adjustment through earnings | ||||
| Fair value of Anson Notes as of March 31, 2025 | ||||
| Conversion and repayments of principal and interest (shares) | ( | ) | ||
| Fair value adjustment through earnings | ||||
| Fair value of Anson Notes as of June 30, 2025 | ||||
| Conversion and repayments of principal and interest (shares) | ( | ) | ||
| Fair value adjustment through earnings | ||||
| Fair value of Anson Notes as of September 30, 2025 | $ | |||
| Convertible note payable - current portion as of September 30, 2025 | $ | |||
| Convertible note payable, net of current portion as of September 30, 2025 | $ |
Warrant Liabilities
The Company utilizes a Black-Scholes model approach to value its liability-classified warrants at each reporting period, with changes in fair value recognized in the condensed consolidated statements of operations. The estimated fair value of the warrant liabilities is determined using Level 3 inputs. There were
The weighted-average significant inputs used in the Black-Scholes model to measure the warrant liabilities that are categorized within Level 3 of the fair value hierarchy are as follows:
|
September 30, 2025 | December 31, 2024 | |||||||
| Stock price on valuation date | $ | $ | ||||||
| Exercise price per share | $ | – | $ | |||||
| Expected life | – | |||||||
| Volatility | % | % | ||||||
| Risk-free rate | – | % | % | |||||
| Dividend yield | % | % | ||||||
| Fair value of warrants | $ | – | $ | |||||
A reconciliation of warrant liabilities is included below (in thousands):
| Balance as of December 31, 2023 | $ | |||
| Loss upon re-measurement | ||||
| Balance as of March 31, 2024 | ||||
| Gain upon re-measurement | ( | ) | ||
| Balance as of June 30, 2024 | $ | |||
| Initial recognition of issuance of warrants | ||||
| Gain upon re-measurement | ( | ) | ||
| Balance as of September 30, 2024 | $ |
| Balance as of December 31, 2024 | $ | |||
| Initial recognition of issuance of warrants | ||||
| Change in fair value of warrant liabilities | ( | ) | ||
| Balance as of March 31, 2025 | $ | |||
| Change in fair value of warrant liabilities | ||||
| Balance as of June 30, 2025 | $ | |||
| Change in fair value of warrant liabilities | ||||
| Fair Value of Anson warrants exercised | ( | ) | ||
| Balance as of September 30, 2025 | $ |
Fair Value on a Nonrecurring Basis
Assets and liabilities that are measured at fair value on a nonrecurring basis relate primarily to tangible property and equipment, goodwill and other intangible assets, which are remeasured when the derived fair value is below carrying value in the consolidated balance sheets. For these assets, the Company does not periodically adjust carrying value to fair value except in the event of impairment. If it is determined that impairment has occurred, the carrying value of the asset is reduced to fair value and the difference is included in impairments and other charges, net in the consolidated statements of operations.
Assets that are measured at fair value and classified as level 3 on a non-recurring basis are as follows (in thousands):
| Description | September 8, 2025 | |||
| Trade name | $ | |||
| Customer relationships | $ | |||
| Non-compete agreements | $ | |||
| Goodwill | $ | |||
All these assets were measured at the acquisition dates in conjunction with the Dura acquisition.
The significant unobservable inputs used in our level 3 fair value measurements during the nine months ended September 30, 2025 are as follows:
| Areas | Valuation Techniques | Unobservable Inputs | Range | |||||
| Trade name | Relief-from-Royalty Method | Royality Rate | % | |||||
|
| ||||||||
| Discount rate | % | |||||||
| Income tax rate | % | |||||||
| Economic useful life |
| |||||||
| Customer relationship | Multi-Period Excess Earnings Method (MPEEM) | Royalty rate | % | |||||
|
|
| |||||||
| Expense Growth Rates | 3 | % | ||||||
| Contributory Assets’ Charges as % from revenue | % | |||||||
| Business development expense for new customers | % | |||||||
| Distributor EBITA margin for customer relationships | % | |||||||
| Discount rate | % | |||||||
| Income tax rate | % | |||||||
| Economic useful life |
| |||||||
| Non-compete agreements | With-and-without method | Replacement cost growth rate | % | |||||
| Cap Ex Rates | % | |||||||
| Contributory Assets Rates | % | |||||||
| After tax rate of return | % | |||||||
| Useful life |
| |||||||
Note 15. Segment Reporting
The Company operates as operating and reportable segments, consistent with the manner in which the Chief Executive Officer, designated as the CODM of the Company, evaluates the Company’s performance and allocates resources. The Company’s operations solely consist of the development of novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, and PTSD and now schizophrenia. On September 8, 2025, HOPE completed the previously announced acquisition of Dura, and a revenue-generating clinical organization. Following the acquisition, the Company began generating patient service revenue through Dura’s operations. As a result, the Company now operates in reportable segments.
The Company generated thousand in revenues during the nine months ended September 30, 2025. The revenue for the three and nine months ended September 30, 2025 represents the revenue generated from Dura. The CODM evaluates performance based on operating expenses and monitors key expense categories related to the Company’s research and development activities, as well as general and administrative functions. As the Company is currently in the pre-revenue phase, the associated expenses above are drivers.
The CODM does not separately evaluate performance by geographic region or product line, as the Company has not yet commenced commercial operations and has limited operations due to the current liquidity and funding of the Company. The Company’s operations are conducted solely within the U.S.
Significant Segment Information
All of the Company’s assets relate to these two operating segments, see the accompanying balance sheets below.
All of the Company’s operating expenses, which consist of research and development and general and administrative expenses, relate to this single operating segment, see the accompanying statements of operations.
The following table reconciles the loss from operations to total loss for the three months ended September 30, 2025 and 2024 (in thousands):
| For the three months | ||||||||||||||||
| ended | ||||||||||||||||
| September 30, | ||||||||||||||||
| NRx | Dura | 2025 | 2024 | |||||||||||||
| Expense Category | ||||||||||||||||
| Income (loss) from operations | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Interest income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest expense | ||||||||||||||||
| Change in fair value of convertible notes payable | ( | ) | ||||||||||||||
| Change in fair value of warrant liabilities | ( | ) | ||||||||||||||
| Loss on convertible note conversions | ||||||||||||||||
| Gain on exercise of warrants | ( | ) | ( | ) | ||||||||||||
| Net loss | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
The following table reconciles the loss from operations to total loss for the nine months ended September 30, 2025 and 2024 (in thousands):
| For the nine months | ||||||||||||||||
| ended | ||||||||||||||||
| September 30, | ||||||||||||||||
| NRx | Dura | 2025 | 2024 | |||||||||||||
| Expense Category | ||||||||||||||||
| (Loss) income from operations | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Interest income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest expense | ||||||||||||||||
| Change in fair value of convertible notes payable | ( | ) | ||||||||||||||
| Change in fair value of warrant liabilities | ( | ) | ||||||||||||||
| Loss on issuance of Registered Direct Offering | ||||||||||||||||
| Loss on Consideration Shares and Warrants | ||||||||||||||||
| Convertible note default penalty | ||||||||||||||||
| Loss on convertible note conversions | ||||||||||||||||
| Gain on exercise of warrants | ( | ) | ( | ) | ||||||||||||
| Net loss | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
Long-lived assets consist of furniture and equipment which are included in furniture and equipment, net in the balance sheet. Long-lived assets by year are as follows (in thousands):
| NRx | Dura | September 30, 2025 | December 31, 2024 | |||||||||||||
| Medical equipment | $ | $ | $ | $ | ||||||||||||
| Computer equipment | ||||||||||||||||
| Furniture and fixtures | ||||||||||||||||
| Total PPE | $ | $ | $ | $ | ||||||||||||
| Less: Accumulated Depreciation | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net | $ | $ | $ | $ | ||||||||||||
Note 16. Income Taxes
The Company recorded
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.
Note 17. Business Acquisitions
Dura Medical, LLC
Transaction Overview
On September 8, 2025, HOPE, a wholly owned subsidiary the Company, completed the acquisition of Dura, a Florida-based behavioral health and interventional psychiatry practice with locations in Naples and Fort Myers, Florida. Dura was founded in 2018 and provides outpatient mental health treatment specializing in evidence-based therapies for treatment-resistant conditions, including depression, anxiety, PTSD, OCD, and chronic pain. Services include ketamine infusion therapy, Spravato® administration, Transcranial Magnetic Stimulation (TMS), Stellate Ganglion Blocks, psychotherapy, and medication management.
The acquisition aligns with the Company’s strategy to expand its clinical care delivery platform through HOPE and establish a multi-site network offering advanced interventional psychiatry services. Management expects the acquisition to accelerate revenue generation and provide a foundation for integrating proprietary therapeutics, including NRX-100 and NRX-101, upon FDA approval.
Consideration Transferred
The preliminary fair value of the consideration transferred was $
The following items were determined to represent post-employment compensation under ASC 805 and ASC 718 and are excluded from the purchase price consideration:
| ● | Issuance of |
| ● | Contingent consideration of up to $ |
These amounts will be accounted for as compensation expense in future periods as services are rendered.
In connection with the acquisition of Dura, the Company incurred total acquisition-related costs of approximately $
Purchase Price Allocation
The Company has applied the acquisition method of accounting in accordance with ASC 805, Business Combinations (“ASC 805”) and recognized assets acquired, and liabilities assumed at their fair value as of the date of acquisition, with the excess purchase consideration recorded to goodwill. As the Company finalizes the estimation of the fair value of the purchase price and the fair value of the assets acquired and liabilities assumed, additional adjustments may be recorded during the measurement period (a period not to exceed 12 months from the acquisition date).
The Company recorded all tangible and identifiable intangible assets acquired and liabilities assumed at their preliminary estimated fair values as of the acquisition date. The preliminary allocation is as follows:
| Preliminary Amount Recognized as of the Acquisition Date (In Thousands) | ||||
| Assets assumed | ||||
| Cash and cash equivalents | $ | |||
| Accounts receivable | ||||
| Prepaid expenses | ||||
| Furniture and equipment | ||||
| Right-of-use asset | ||||
| Right-of-use asset - related party | ||||
| Customer relationship | ||||
| Trade name | ||||
| Non-compete agreements | ||||
| Goodwill | ||||
| Total assets acquired | $ | |||
| Liabilities assumed | ||||
| Accounts payable and accrued expenses | $ | ( | ) | |
| Accrued salaries and benefits | ( | ) | ||
| Operating lease liability | ( | ) | ||
| Operating lease liability - related party | ( | ) | ||
| Total liabilities assumed | $ | ( | ) | |
| Net assets acquired | $ |
Certain adjustments of approximately $
Intangible Assets
The Company identified the following finite-lived intangible assets, which will be amortized on a straight-line basis over their estimated useful lives once finalized:
| ● | Trade Name – includes the “Dura Medical” name and associated trademarks. |
| ● | Customer relationship – representing the value of established patient relationships and referral sources. |
| ● | Non-Compete Agreements – arising from restrictive covenants in the purchase agreement. |
The acquired intangible assets are being amortized over their estimated useful lives as follows (in thousands):
| Weighted Average | ||||||||
| Useful Life | ||||||||
| Fair Values | (Years) | |||||||
| Trade name and trademarks | $ | |||||||
| Customer relationships | ||||||||
| Non-compete agreement | ||||||||
| Total intangible assets | ||||||||
| Less accumulated amortization | ( | ) | ||||||
| Net carry value | $ | |||||||
The Company incurred amortization expense of $
As of September 30, 2025, the maturities of the Company’s intangible assets were as follows (in thousands):
| 2025 | $ | |||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| Thereafter | ||||
| Total | $ |
Goodwill
Goodwill of approximately $
Measurement Period
The Acquisition was recorded as a business combination on a preliminary valuation of assets acquired and liabilities assumed at their acquisition date fair values using unobservable inputs that are supported by little or no market activity and are significant to their fair value of the assets and liabilities (“Level 3” inputs). We expect to complete our purchase price allocation, as well as our fair value estimate of the purchase price consideration as soon as reasonably possible, not to exceed one year from the acquisition date. Adjustments to the preliminary purchase price and allocation could be material. Goodwill and intangible assets represent the excess of the purchase price consideration over the preliminary valuation of the other net assets acquired.
As of September 30, 2025, the purchase price allocation remains preliminary, and the purchase price may be subject to final adjustments. The Company is continuing to assess the fair values of certain identifiable intangible assets and contingent liabilities, including the potential adjustment to exchangeable shares.
Pro-Forma Financial Information (Unaudited)
The following unaudited pro forma information presents the consolidated results of Dura included in the Company’s unaudited condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2025, as if the acquisition was made on January 1, 2025, and operations for the three and nine months ended September 30, 2024, as if the Acquisition had occurred on January 1, 2024. The unaudited pro forma information is presented for illustrative purposes only. It is not necessarily indicative of the results of operations of future periods, or the results of operations that actually would have been realized had the entities been a single company during the periods presented or the results that the combined company will experience after the acquisition. The unaudited pro forma information does not give effect to the potential impact of current financial conditions, regulatory matters or any anticipated synergies, operating efficiencies or cost savings that may be associated with the acquisition. The unaudited pro forma information also does not include any integration costs or remaining future transaction costs that the companies may incur related to the acquisition as part of combining the operations of the companies.
The unaudited pro forma consolidated results of revenue and net loss, assuming the acquisition had occurred on January 1, 2025, is as follows (in thousands):
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||
| 2025 | 2025 | |||||||
| Revenue | $ | $ | ||||||
| Net loss | ( | ) | ( | ) | ||||
The unaudited pro forma consolidated results of revenue and net loss, assuming the acquisitions had occurred on January 1, 2024, is as follows (in thousands):
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||
| 2024 | 2024 | |||||||
| Revenue | $ | $ | ||||||
| Net loss | ( | ) | ( | ) | ||||
The unaudited pro forma results for the three and nine months ended September 30, 2025, include material nonrecurring adjustments of million and $
The unaudited pro forma results for the three and nine months ended September 30, 2024, include material nonrecurring adjustments of million and million, respectively, related to the amortization of intangible assets acquired in connection with the Dura acquisition and approximately $
For the three and nine months ended September 30, 2025, the operating expenses of Dura included in the Company’s consolidated statement of operations and comprehensive loss were insignificant to the Company’s financial results. Net patient service revenue and net income attributable to Dura for the nine months ended September 30, 2025, and included in the Company’s consolidated statement of operations, were $
Note 18. Related Party Transactions
Glytech Agreement
The Company licenses patents that are owned by Glytech, LLC (“Glytech”), pursuant to a license agreement (the “Glytech Agreement”). Glytech is owned by Daniel Javitt, the co-founder and a former director of the Company. The Glytech Agreement requires that the Company pay Glytech for ongoing scientific support and also reimburse Glytech for expenses of obtaining and maintaining patents that are licensed to the Company. During the three months ended September 30, 2025 and 2024, the Company paid Glytech $
The Fourth Amendment to the Glytech Agreement, effective as of December 31, 2020, includes an equity value-triggered transfer of Excluded Technology from Glytech to the Company. The Excluded Technology is defined in the Glytech Agreement as any technology, and any know-how related thereto, covered in the licensed patents that do not recite either D-cycloserine or lurasidone individually or jointly. This definition would cover pharmaceutical formulations, including some that the Company considers “pipeline” or “future product” opportunities, which 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 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 $
Consulting Agreement with Dr. Jonathan Javitt
The Chief Scientist of the Company, Dr. Jonathan Javitt, is a major stockholder of the Company and a member of the Board. Therefore, his services are deemed to be a related party transaction. He served the Company on a full-time basis as chief executive officer 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 $
On March 29, 2023, the consulting agreement dated March 8, 2022 (the “Javitt Consulting Agreement”) between the Company and Dr. Jonathan Javitt was amended to extend the term of the Javitt Consulting Agreement until March 8, 2024 with automatic annual renewals thereafter unless one party or the other provides notice of non-renewal. The amendment also provided for payment at the rate of $
Consulting Agreement with Zachary Javitt
Zachary Javitt is the son of Dr. Jonathan Javitt. Zachary Javitt provides services related to website, IT, and marketing support under the supervision of the Company’s chief executive officer who is responsible for assuring that the services are provided on financial terms that are at market. The Company paid this family member a total of less than $
Included in accounts payable were $
Note 19. Subsequent Events
On October 17, 2025, the Company, through its subsidiary HOPE completed its acquisition of a strategic and minority interest in Cohen & Associates, LLC, a Florida limited liability company (“Cohen LLC”) for cash consideration of $
In connection with the transaction, Dr. Rebecca Cohen was appointed Medical Director of HOPE, and the terms of employment include certain financial incentives to establish and grow new sites of care owned or operated by HOPE.
From October 6, 2025 through November 12, 2025, the Company sold an aggregate of
On October 1, 2025, the Company received $
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of NRx Pharmaceuticals’ financial condition and plan of operations together with NRx Pharmaceuticals' condensed consolidated financial statements and the related notes appearing elsewhere herein. In addition to historical information, this discussion and analysis contains forward looking statements that involve risks, uncertainties, and assumptions. NRx Pharmaceuticals’ actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section entitled “Risk Factors” included elsewhere herein. All references to “Note,” followed by a number reference from 1 to 15 herein, refer to the applicable corresponding numbered footnotes to these condensed consolidated financial statements.
Overview
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”, “we”, “us” or “our”) is a clinical-stage bio-pharmaceutical company which develops and will distribute, through its wholly-owned operating subsidiary, NeuroRx, Inc., (“NeuroRx”), novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, post-traumatic stress disorder (“PTSD”) and schizophrenia. NRx is additionally the founder and majority owner of HOPE Therapeutics, Inc. (“HOPE”), a medical services company that offers interventional psychiatry care to patients with treatment-resistant depression and PTSD with a combination of neuroplastic drugs, transcranial magnetic stimulation (“TMS”), digital therapeutics, and hyperbaric therapy. All of our current drug development activities are focused on drugs that enhance neuroplasticity by modulating 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 – NRX-100, a preservative-free formulation of ketamine for intravenous infusion, and NRX-101, an oral fixed dose combination of D-cycloserine (“DCS”) and lurasidone. NRX-100 and NRX-101 are in the process of submission for Food and Drug Administration (“FDA”) approval as follows:
| 1. |
An Abbreviated New Drug Application (“ANDA”) for NRX-100 was filed, with priority review requested, during the third quarter of 2025. After meeting with the FDA in August 2025, the Company re-filed the ANDA, following FDA notification of approval of a suitability petition for NRx’s proposed strength of preservative-free ketamine, KETAFREETM. On November 6, 2025, the Company received a communication from the FDA in which no significant deficiencies were identified in the revised filing. This letter is consistent with the Company’s ambition to launch KETAFREE™ in Q1 2026. The Company has additionally submitted a citizen petition seeking to have benzethonium chloride, a toxic preservative, removed from all commercial presentations of ketamine. |
| 2. |
A New Drug Application (“NDA”) for NRX-100, originally initiated during the fourth quarter of 2024, is expected to be completed in the fourth quarter 2025. This follows award of Fast Track Designation by the FDA for the Company’s expanded indication of “Treatment of Suicidal Ideation in Depression, including Bipolar Depression.” A key element of the Company’s PDUFA strategy has focused on obtaining data to confirm the ketamine efficacy seen in clinical trials conducted under governmental auspices in the US and France. The Company has now arranged to submit Real World Efficacy Data drawn from 65,000 patients treated for depression with intravenous ketamine compared to 6,000 patients treated with intranasal S-ketamine, which will be submitted as part of the NDA. An interim analysis drawn from the first 20,000 patients suggests that IV ketamine may have a more rapid onset of action and larger magnitude of effect than nasal S-ketamine. The Company has applied to receive a Commissioner’s National Priority Voucher (CNPV), which could significantly reduce review time. The Company has completed all required manufacturing steps and demonstrated room temperature shelf stability to support a three year shelf life. |
| 3) |
An NDA filing for NRX-101 has been initiated with the submission of the Module 3 manufacturing file to the FDA. The drug was previously awarded Breakthrough Therapy Designation and accordingly the Company is requesting rolling review from the NDA. Breakthrough Therapy Designation is granted by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions that address an unmet medical need and have demonstrated preliminary evidence of efficacy as determined by the FDA. Based on current data, the Company aims to seek accelerated approval for use of NRX-101 in patients with bipolar depression who exhibit suicidal ideation on currently approved medication. |
| 4) |
In the third quarter, the Company was made aware of dramatic findings suggesting that low-dose D-cycloserine (the key ingredient in NRX-101) may increase the antidepressant and antisuicidal effects of TMS by more than 2-fold, as demonstrated in a randomized controlled trial and subsequently confirmed with real world experience and mechanistic studies. Accordingly, the Company has filed a protocol with the FDA to test the use of low-dose NRX-101 in conjunction with the one-day TMS protocol (ONE-D) that has been published in association with the FDA-cleared Ampa Health TMS device. Should this study demonstrate safety and efficacy, it could represent a dramatic expansion of the market for NRX-101 and have the potential to offer patients a rapid remission from severe depression and PTSD with a single day of treatment. Millions of Americans are expected to be treated with TMS in coming years. Success in this planned clinical trial would lead to a 2027 PDUFA date for this previously unanticipated indication. |
As previously announced, in February 2024, NRx incorporated HOPE Therapeutics, a medical care delivery organization focused on providing cutting-edge, comprehensive interventional psychiatric treatment with the most effective treatments available, including NMDA-targeted and other neuroplastic drugs, such as ketamine, Spravato and NRX-101, neuromodulatory devices, such as TMS, hyperbaric therapy, digital therapeutics, and medication management.
On December 2, 2024, HOPE formed HTX Management Company, LLC, a wholly owned subsidiary organized as a Delaware limited liability company, for the purpose of supporting future operations associated with any acquired businesses.
On September 8, 2025, HOPE became a revenue-generating clinical enterprise through its completion of the previously announced acquisition of Dura Medical, LLC (“Dura”), a Florida limited liability company, and a revenue-generating clinical organization with locations in Naples and Ft. Myers, Florida. Founded in 2018, Dura offers precision-based interventional psychiatry services, including ketamine infusion therapy, TMS, Spravato®, stellate ganglion blocks, and psychotherapy.
Subsequent to the third quarter, the Company completed the previously announced addition of Cohen and Associates, based in Sarasota, FL, to the HOPE Network with a strategic minority investment, which expanded HOPE’s footprint on the West Coast of Florida, and related appointment of Dr. Rebecca Cohen as HOPE’s Medical Director. On November 10, 2025, HOPE announced completion of clinical training on the Ampa Health TMS device and initiation of the ONE-D protocol at its Florida locations. The ONE-D protocol has been reported in the peer-reviewed literature to achieve 87% response and 72% remission from severe depression at 6 weeks following a single day of TMS treatment, combined with D-cycloserine. HOPE is the first clinical enterprise to offer this one-day treatment protocol in Florida and one of the first to offer this therapy nationwide.
Through the third 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
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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. |
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Re-filing of an Abbreviated New Drug Application (“ANDA”) for NRX-100 (preservative-free intravenous ketamine) following FDA notice of approval of its Suitability Petition for NRx’s proposed strength of preservative-free ketamine, KETAFREE™. On November 6, 2025 the Company received a communication from FDA that did not identify any major deficiencies in the revised ANDA submission consistent with ANDA approval in Q2 2026. |
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Filing of Commissioner’s National Priority Voucher application for intravenous ketamine (NRX-100). Subsequently, the Company was invited to attend a closed-door listening session with the FDA Commissioner and senior staff. |
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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. |
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Submission of draft labeling for NRX-100 in the treatment of suicidal depression based on the Fast Track Designation received. |
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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. |
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Filing of a Citizen 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. |
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Filing of a patent application for NRX-100, the Company’s proprietary preservative-free formulation of intravenous ketamine. |
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Receipt of filing fee waiver from the FDA for NRX-100. |
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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. |
HOPE Therapeutics
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Completed the acquisition of Dura Medical and subsequent acquisition of an interest in Cohen and Associates, LLC with first clinical revenue recorded during Q3. |
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Appointment of Dr. Rebecca Cohen as HOPE’s Medical Director. |
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Completion of clinical training and First-in-Florida initiation of one day depression treatment (ONE-D) utilizing D-cycloserine and the Ampa Health FDA-cleared TMS device. |
Recent Developments
Financing
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 September 30, 2025, in connection with the at-the-market offering, the Company sold an aggregate of 1,350,788 shares of Common Stock for approximately $3.81 million, net of less than $0.1 million in transaction costs. During the nine months ended September 30, 2025, in connection with the at-the-market offering, the Company sold an aggregate of 1,749,866 shares of Common Stock for approximately $4.75 million, net of $0.1 million in transaction costs. Pursuant to the Anson Purchase Agreement, on January 28, 2025, the Company issued $5.4 million of Third Tranche Anson Notes at an 8% original issue discount for total cash proceeds of approximately $5.0 million. On August 18, 2025, the Company entered into the Second RD Purchase Agreement with certain accredited investors for the sale of an aggregate of 3,959,999 shares of the Company’s Common Stock, at a purchase price of $1.65 per share. The Second Registered Direct Offering closed on August 18, 2025, and resulted in net proceeds of approximately $6.2 million, after deducting placement agent fees and other offering-related expenses of approximately $0.3 million. On September 30, 2025, the 1,870,960 shares underlying Anson Warrants were exercised for cash proceeds of $3.09 million. Because the exercise proceeds were received subsequent to September 30, 2025, the Company recorded a subscription receivable asset of $3.09 million as of September 30, 2025. The exercise proceeds of $3.09 million were received on October 1, 2025.
Although no assurances can be given, management believes that it will be able to secure necessary financing to support and consummate both its previously announced acquisitions and potential future acquisition candidates, execute its business plan and achieve its projected revenue objectives.
Drug Development
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 Citizen Petition with the 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 the FDA no longer allows BZT to be used in hand cleansers and topical antiseptics.1 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.
1 Toxicological Evaluation of Benzethonium Chloride in Ketamine Formulations. Zenodo. https://doi.org/10.5281/zenodo.16883346)
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.
The first filing of the ANDA in June 2025 received a “Refuse to Receive” letter from the FDA primarily based on a difference in the concentration of a single inactive ingredient (sodium chloride) between the NRX-100 formulation and the reference formulation of KETALAR®. The Company met with leadership of the Office of Generic Drugs and agreed to adjust the sodium chloride concentration to within 5% of the reference product. The ANDA was refiled in September 2025 and the Company received a letter in November 2025 identifying only several minor administrative discrepancies, all of which have now been addressed without starting a new regulatory cycle. The Company is aware of no impediments to an acceptance of the ANDA package and anticipates regulatory action in the Q2 2026 time frame.
The request by the FDA to alter the sodium chloride level in the ANDA formulation creates a permanent formulation difference between the ANDA product (KETAFREE™) and the NRX-100 innovative product. This difference will result in two different drug identification numbers post approval and will enable the Company to establish different commercial paths for KETAFREE™ and NRX-100. Ongoing stability data remains on track for three years of room temperature shelf stability, the maximum allowed for a sterile injectable product.
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. Originally, in 2017, the FDA awarded FTD to NRX-100 in association with NRX-101 for the treatment of suicidal bipolar depression. During the current quarter, the 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), 3.6 million Americans contemplate suicide each year, with 1.5 million attempting suicide and an American dying of suicide every 11 minutes.
The 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.
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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. |
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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. |
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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. |
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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. |
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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 70,000 and 1,200 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 results observed in randomized clinical trials. Unlike the randomized trials that compared ketamine to placebo and active comparator, the Real World Data also compares intravenous ketamine to intranasal SPRAVATO® with favorable findings.
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-101: Original indication in Bipolar Depression
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 the FDA on the grounds of overwhelming public health need.
NRX-101: New indication in augmenting the effects of Transcranial Magnetic Stimulation (TMS).
In the third quarter, the Company identified a promising new indication for NRX-101 that potentially offers rapid path to commercialization for this Breakthrough Therapy-designated drug. Recent evidence suggests that NRX-101 may confer a significant added advantage to the clinical results of Transcranial Magnetic Stimulation.2 Cole and colleagues reported that patients randomized to DCS vs. Placebo concurrent with TMS using a standard protocol experienced a greater than two-fold benefit in terms of reduction in symptoms of depression. Clinical response of 75% and remission of 40% was seen in the DCS-treated group.
A substantial body of nonclinical literature has been published in subsequent years demonstrating that DCS at low doses exerts a neuroplasticity effect and causes dendritic sprouting in areas of the brain associated with depression.
On November 4, 2025, Real World Data were presented in conjunction with use of the Ampa TMS device and a one day TMS protocol, combined with a single administration of oral DCS.3 The authors reported 87% clinical response and 72% remission manifesting at 6 weeks after a single day of treatment on the Hamilton Depression Rating Scale with similar findings on other standard test measures.
2 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
3 Vaughn, Donald & Marino, Brooke & Engelbertson, Alex & Dojnov, Aleksandra & Weiss, Nick & Vila-Rodriguez, Fidel & Nanos, Georgine & Downar, Jonathan. (2024). Real-world effectiveness of a single-day regimen for transcranial magnetic stimulation using Optimized, Neuroplastogen-Enhanced techniques in Depression (ONE-D). 10.21203/rs.3.rs-5679327/v1.
Although the above studies were conducted with DCS alone, the Seromycin® (D-cycloserine) label lists a clear contra-indication for the use of DCS in patients with depression. That contraindication was part of the basis for the agreement between NRx and the FDA to combine DCS and lurasidone into NRX-101 and the FDA’s decision to assign an indication for NRX-101 together with Breakthrough Therapy Designation in the treatment of Bipolar Depression. The Company has now filed with the FDA to expand the Breakthrough Therapy indication to the treatment of Treatment-resistant Depression.
Based on the above findings, NRX-101 containing comparable doses of D-cycloserine is now being offered to physicians treating with TMS who are willing to provide NRx with outcomes data. The Company is now planning a phase 3 registration trial for the use of NRX-101 vs. placebo in conjunction with Theta-burst TMS. Based on the rapid adoption of accelerated TMS and the dramatic results seen, we estimate that between 1 and 3 million Americans will receive TMS for depression annually. The Company holds numerous composition of matter and method patents on the use of NRX-101 that have the potential to create a substantial period of market exclusivity should the drug be approved.
HOPE Therapeutics: Operating Progress
In the last month of the quarter, NRx consummated, through its HOPE subsidiary, its first clinic acquisition (Dura) leading to its first revenue from operations. Note that the revenue shown on the financial statement represents only three weeks of clinical revenue and that revenues are expected to grow as more clinical footprint is acquired. In October 2025, the NRx, through its HOPE subsidiary, completed the acquisition of a minority interest in Cohen.
Subsequent to the quarter, NRx became the first clinical entity to partner with Ampa Health in the State of Florida and one of the first nationwide. The Ampa device is unique because of the results demonstrated with the ONE-D protocol and the dramatic rate of clinical response (87%) and remission (72%) seen when this TMS device is combined with the key ingredient of NRX-101. The Company is in active acquisition mode and is also establishing partnerships with TMS providers that could enable HOPE to enter into a Medical Services Organization (MSO) structure with partner entities.
In October 2018, the Company was the only commercial entity invited to participate in the national Stop Suisilence weekend at the US Army Museum at Fort Belvoir, VA. HOPE’s CEO presented opposite active duty and retired members of the US military including numerous flag officers and the Senior Advisor to the Secretary of Veterans Affairs. HOPE has active contracts to provide care to Veterans through the Veterans Health Administration and to Active Duty and Retired military personnel through TRICARE. Reimbursement is provided for approved drugs and therapies including SPRAVATO and TMS, together with administration of intravenous ketamine, which remains an off-label use, pending approval of NRX-100.
Financial Results
Since inception, the Company has incurred significant operating losses. For the three months ended September 30, 2025 and 2024, the Company’s net loss was $5.9 million and $1.6 million, respectively. For the nine months ended September 30, 2025 and 2024, the Company’s net loss was $29.0 million and $16.1 million, respectively. As of September 30, 2025, the Company had an accumulated deficit of $307.3 million, a stockholders’ deficit of $25.8 million and a working capital deficit of $28.7 million.
Going Concern
The Company’s ongoing clinical activities continue to generate losses and net cash outflows from operations. The Company plans to pursue additional equity or debt financing or refinancing opportunities to fund ongoing clinical activities, to meet obligations under its current debt arrangements and for the general corporate purposes of the Company. Such arrangements may take the form of loans, equity offerings, strategic agreements, licensing agreements, joint ventures, or other agreements. The sale of equity could result in additional dilution to the Company’s existing stockholders. The Company cannot make any assurances that additional financing will be available to it and, if available, on acceptable terms, or that it will be able to refinance its existing debt obligations which could negatively impact the Company’s business and operations and could also lead to a reduction in the Company’s operations. The Company will continue to carefully monitor the impact of its continuing operations on its working capital needs and debt repayment obligations. As such, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least twelve months from the date of issuance of these condensed consolidated financial statements. The Company may raise substantial additional funds, and if it does so, it may do so through one or more of the following: issuance of additional debt or equity and/or the completion of a licensing or other commercial transaction for one of the Company’s product candidates.
The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that may be necessary if the Company is unable to continue as a going concern.
Components of Results of Operations
Revenues
The Company recognizes patient service revenue in accordance with ASC 606, Revenue from Contracts with Customers. Revenue is recognized as performance obligations are satisfied, which occurs over time as patients simultaneously receive and consume the benefits of the services provided. Each treatment or visit generally represents a separate contract.
Procedural services, such as ketamine infusions, esketamine administration, TMS sessions, and SGB/epidural procedures, are recognized at the point in time when services are rendered.
For the three and nine months ended September 30, 2025, the Company recorded total revenue of approximately $0.2 million, which was solely attributable to patient services provided by Dura following its acquisition on September 8, 2025. Prior to the acquisition, the Company did not generate revenue as it was in the development stage and primarily focused on corporate formation, financing, and acquisition-related activities.
The initial post-acquisition revenue reflects only a partial period of operations and therefore is not indicative of the Company’s expected ongoing revenue levels. Management anticipates that revenue will increase in subsequent periods as Dura’s operations are fully integrated and additional clinical capacity, patient volume, and service lines are expanded under the Company’s ownership.
Operating Expense
Cost of patient services
Cost of patient services consists primarily of direct expenses associated with providing healthcare services, including salaries and benefits for clinical personnel, medical supplies, pharmaceuticals, and other costs directly attributable to patient care. These costs are expensed as incurred.
For the three and nine months ended September 30, 2025, cost of patient services related solely to operations of Dura following its acquisition on September 8, 2025. Given the limited period of post-acquisition operations, current cost levels are not representative of the Company’s expected ongoing operating costs. Management anticipates that cost of patient services will increase in proportion with the expected growth in patient volumes and expansion of clinical activities in future periods.
Research and development expense
The Company’s research and development expense consists primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and equity-based compensation charges for those individuals involved in ongoing research and development efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received.
General and administrative expense
General and administrative expenses consist primarily of salaries, stock-based compensation, consultant fees, and professional fees for legal and accounting services.
Settlement (income) expense
Settlement (income) expense during the three and nine months ended September 30, 2025, consists of amounts related to the resolution of legal claims and income recognized from the reduction of previously accrued settlement liabilities, as certain matters were settled for less than originally estimated.
Results of operations for the three months ended September 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 September 30, |
Change |
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| 2025 |
2024 |
Dollars |
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| (Unaudited) |
||||||||||||
| Net patient service revenue |
$ | 242 | $ | — | $ | 242 | ||||||
| Operating expense: |
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| Cost of patient services |
$ | 97 | $ | — | $ | 97 | ||||||
| Research and development |
1,429 | 611 | 818 | |||||||||
| Selling, general and administrative |
2,808 | 2,409 | 399 | |||||||||
| Depreciation and amortization |
26 | 2 | 24 | |||||||||
| Settlement (income) expense |
(94 | ) | — | (94 | ) | |||||||
| Total operating expense |
4,266 | 3,022 | 1,244 | |||||||||
| Loss from operations |
$ | (4,024 | ) | $ | (3,022 | ) | $ | (1,002 | ) | |||
| Other expense (income): |
||||||||||||
| Interest income |
$ | (2 | ) | $ | (6 | ) | $ | 4 | ||||
| Interest expense |
— | — | — | |||||||||
| Change in fair value of convertible note payable |
1,502 | (1,355 | ) | 2,857 | ||||||||
| Change in fair value of warrant liabilities |
4,963 | (165 | ) | 5,128 | ||||||||
| Loss on issuance of Registered Direct Offering |
— | — | — | |||||||||
| Loss on Consideration Shares and Warrants |
— | — | — | |||||||||
| Convertible note default penalty |
— | — | — | |||||||||
| Loss on convertible note conversions |
772 | 127 | 645 | |||||||||
| Gain on exercise of warrants |
(5,369 | ) | — | (5,369 | ) | |||||||
| Total other expense |
1,866 | (1,399 | ) | 3,265 | ||||||||
| Loss before tax |
(5,890 | ) | (1,623 | ) | (4,267 | ) | ||||||
| Net loss |
$ | (5,890 | ) | $ | (1,623 | ) | $ | (4,267 | ) | |||
Net patient service revenue
For the three months ended September 30, 2025, the Company recorded $0.2 million in net patient service revenues from the clinical services provided by Dura following the acquisition dated September 8, 2025. The Company did not record revenues for the three months ended September 30, 2024.
Operating expense
Cost of patient services
For the three months ended September 30, 2025, the Company recorded $0.1 million in costs of patient services, as compared to $0 incurred during the three months ended September 30, 2024. This increase can be attributed to the acquisition of Dura on September 8, 2025.
Research and development expense
For the three months ended September 30, 2025, the Company recorded $1.4 million of research and development expense, as compared to approximately $0.6 million for the three months ended September 30, 2024. The increase of $0.8 million is related primarily due to a $0.4 million increase in clinical trials and development and a $0.3 million increase in regulatory and process development consulting costs. The research and development expense for each of the three months ended September 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 September 30, 2025, the Company recorded $2.8 million of general and administrative expense, as compared to approximately $2.4 million for the three months ended September 30, 2024. The increase of $0.5 million is related primarily to an increase of $0.9 million in employee expenses and $0.1 in legal and professional expenses, partially offset by a decrease of $0.4 million in consulting costs and $0.2 million in insurance costs. General and administrative expense includes less than $0.1 million of non-cash stock-based compensation for both of the three months ended September 30, 2025 and 2024.
Settlement (income) expense
For the three months ended September 30, 2025, the Company recognized settlement income of approximately $0.1 million resulting from the adjustment of previously accrued settlement amounts, as certain legal matters were settled for less than initially accrued. The Company did not incur any settlement income or expense during the three months ended September 30, 2024.
Depreciation and amortization
Depreciation and amortization expense increased to $26 for the nine months ended September 30, 2025, compared to $2 for the same period in 2024, primarily due to the recognition of depreciation and amortization on property and equipment and intangible assets acquired in the Dura acquisition completed in September 2025.
Other expense (income)
Interest income
For the three months ended September 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 September 30, 2024.
Change in fair value of convertible notes payable
For three months ended September 30, 2025, the Company recorded a loss of $1.5 million related to the change in fair value of the convertible notes payable which are accounted for under the fair value option. For the three months ended September 30, 2024, the Company recorded a gain of $1.4 million related to the change in fair value of the convertible note payable which is accounted for under the fair value option.
Change in fair value of warrant liabilities
For the three months ended September 30, 2025, the Company recorded a loss of $5.0 million related to the change in fair value of the warrant liabilities, as compared to a gain of $0.2 million for the three months ended September 30, 2024. The increase in loss during the three months ended September 30, 2025 was attributed to the warrants issued in conjunction with the First, Second and Third Tranches of the Anson Notes, additional shares of Anson Warrants issued as a result anti-dilutive provision, as well as increase in the Company’s stock prices.
Loss on convertible note conversions
For the three months ended September 30, 2025, the Company recorded a loss of $0.8 million related to convertible note conversion, as compared to a loss of $0.1 million during the three months ended September 30, 2024. These conversions were calculated as the difference between the conversion price per the terms of the Anson first tranche senior secured convertible notes agreements relative to the fair value of the Common Stock on the date of conversion as described further under footnote 10 to the accompanying unaudited condensed consolidated financial statements.
Gain on exercise of warrants
For the three months ended September 30, 2025, the Company recorded a $5.4 million gain on the exercise of warrants. This results from the settlement of the warrant liability for exercised warrants (see Note 12).
Results of operations for the nine months ended September 30, 2025 and 2024
The following table sets forth the Company’s selected statements of operations data for the following periods (in thousands):
| Nine months ended September 30, |
Change |
|||||||||||
| 2025 |
2024 |
Dollars |
||||||||||
| (Unaudited) |
||||||||||||
| Net patient service revenue |
$ | 242 | $ | — | $ | 242 | ||||||
| Operating expense: |
||||||||||||
| Cost of patient services |
$ | 97 | $ | — | $ | 97 | ||||||
| Research and development |
3,219 | 5,163 | (1,944 | ) | ||||||||
| Selling, general and administrative |
8,492 | 10,903 | (2,411 | ) | ||||||||
| Depreciation and amortization |
28 | 4 | 24 | |||||||||
| Settlement (income) expense |
6 | — | 6 | |||||||||
| Total operating expense |
11,842 | 16,070 | (4,228 | ) | ||||||||
| Loss from operations |
$ | (11,600 | ) | $ | (16,070 | ) | $ | 4,470 | ||||
| Other expense (income): |
||||||||||||
| Interest income |
$ | (8 | ) | $ | (40 | ) | $ | 32 | ||||
| Interest expense |
— | 230 | (230 | ) | ||||||||
| Change in fair value of convertible note payable |
8,032 | (1,014 | ) | 9,046 | ||||||||
| Change in fair value of warrant liabilities |
8,481 | (174 | ) | 8,655 | ||||||||
| Loss on issuance of Registered Direct Offering |
730 | — | 730 | |||||||||
| Loss on Consideration Shares and Warrants |
1,277 | — | 1,277 | |||||||||
| Convertible note default penalty |
— | 849 | (849 | ) | ||||||||
| Loss on convertible note conversions |
4,239 | 127 | 4,112 | |||||||||
| Gain on exercise of warrants |
(5,369 | ) | — | (5,369 | ) | |||||||
| Total other expense |
17,382 | (22 | ) | 17,404 | ||||||||
| Loss before tax |
(28,982 | ) | (16,048 | ) | (12,934 | ) | ||||||
| Net loss |
$ | (28,982 | ) | $ | (16,048 | ) | $ | (12,934 | ) | |||
Net patient service revenue
For the nine months ended September 30, 2025, the Company recorded $0.2 million in net patient service revenues from the clinical services provided by Dura following the acquisition dated September 8, 2025. The Company did not record revenues for the nine months ended September 30, 2024.
Operating expenses
Cost of patient services
For the nine months ended September 30, 2025, the Company recorded $0.1 million in costs of patient services, as compared to $0 incurred during the nine months ended September 30, 2024. This increase can be attributed to the acquisition of Dura completed on September 8, 2025.
Research and development expense
For the nine months ended September 30, 2025, the Company recorded $3.2 million of research and development expense, as compared to approximately $5.2 million for the nine months ended September 30, 2024. The decrease of $2.0 million is mainly related primarily due to the conclusion of the phase 2 study related to NRX-101 and the Company's cash conservation efforts, $0.3 million in clinical costs, $1.4 million in other regulatory and process development costs, and $0.3 million in regulatory and process consultants’ fees. The research and development expense for each of the nine months ended September 30, 2025 and 2024, respectively, includes less than $0.1 million of non-cash stock-based compensation.
General and administrative expense
For the nine months ended September 30, 2025, the Company recorded $8.5 million of general and administrative expense, as compared to approximately $10.9 million for the nine months ended September 30, 2024. The decrease of $2.4 million is primary related to a decrease of $2.5 million in consultant fees, $0.4 million in insurance expense and $0.4 million by other administrative expenses, offset by increase of $0.6 million in employee expenses and $0.3 million in legal expense. General and administrative expense includes $0.7 million and $0.3 million of non-cash stock-based compensation for the nine months ended September 30, 2025 and 2024, respectively.
Depreciation and amortization
Depreciation and amortization expense increased to $28,000 for the nine months ended September 30, 2025, compared to $4,000 for the same period in 2024, primarily due to the recognition of depreciation and amortization on property and equipment and intangible assets acquired in the Dura acquisition completed in September 2025.
Settlement (income) expense
For the nine months ended September 30, 2025, the Company recognized settlement income of less than $0.1 million resulting from the adjustment of previously accrued settlement amounts, as certain legal matters were settled for less than initially accrued. The Company did not incur any settlement income or expense during the nine months ended September 30, 2024.
Other expense (income)
Interest income
For the nine months ended September 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 nine months ended September 30, 2024.
Interest expense
For the six months ended September 30, 2025, the Company recorded $0 of interest expense, as compared to $0.2 million of interest expense for the nine months ended September 30, 2024. The decrease of $0.2 million is due to premiums for cash payments on the convertible note for the nine months ended September 30, 2024. The interest expense on the convertible notes is embedded in the change in fair value of convertible notes payable, which are accounting for under the fair value option.
Convertible note default penalty
For the nine months ended September 30, 2025, the Company recorded no default penalty, as compared to $0.8 million of a default penalty for the nine months ended September 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 nine months ended September 30, 2025.
Change in fair value of convertible notes payable
For nine months ended September 30, 2025, the Company recorded a loss of $8.0 million related to the change in fair value of the convertible notes payable which are accounted for under the fair value option. For the nine months ended September 30, 2024, the Company recorded loss of $1.0 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 nine months ended September 30, 2025, the Company recorded a loss of $8.5 million related to the change in fair value of the warrant liabilities, as compared to a gain of $0.2 million for the nine months ended September 30, 2024. The increase in loss during the nine months ended September 30, 2025 was attributed to the warrants issued in conjunction with the First, Second and Third Tranches of the Anson Notes and the effects of the full ratchet antidilution trigger on the Anson Warrants in the third quarter of 2025, as well as increase in the Company’s fair value of its common shares.
Loss on issuance of Registered Direct Offering
For the nine months ended September 30, 2025, the Company recorded a loss of $0.7 million related to the issuance of the First Registered Direct Offering, as compared to $0 during the nine months ended September 30, 2024. As the fair value of the warrant liabilities issued in the Registered Direct Offering exceeded the net proceeds received of $3.3 million, the Company recognized the excess of the fair value over the net proceeds received of $3.26 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 September 30, 2025.
Loss on Considerations shares and warrants
For the nine months ended September 30, 2025, the Company recognized a $1.3 million loss related to the March 20, 2025 issuance of 303,819 Consideration Shares and 303,819 Consideration Warrants to Anson under the terms of CWA. This loss, totaling $1.3 million, was recorded within other expense in the condensed consolidated statement of operations.
Loss on convertible note conversion
For the nine months ended September 30, 2025, the Company recorded a loss of $4.2 million related to convertible note conversion, as compared to $0.1 million during the nine months ended September 30, 2024. These conversions were calculated as the difference between the conversion price per the terms of the Anson first tranche senior secured convertible note agreements relative to the fair value of the Common Stock on the date of conversion as described further under footnote 10 to the accompanying unaudited condensed consolidated financial statements.
Gain on exercise of warrants
For the nine months ended September 30, 2025, the Company recorded a $5.4 million gain on the exercise of Anson warrants, resulting from the settlement of warrant liabilities for exercised awarrants (See Note 12).
Liquidity and Capital Resources
The Company has generated minimal revenues, has incurred operating losses since inception, expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. Until such time as the Company is able to establish a significant revenue stream from the sale of its therapeutic products, it is dependent upon obtaining necessary equity and/or debt financing to continue operations. The Company cannot make any assurances that sales of NRX-101 will commence in the near term or that additional financings will be available to it on acceptable terms or at all. This could negatively impact our business and operations and could also lead to the reduction of our operations.
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 under the Offering Agreement for an aggregate of $4.9 million (the “ATM Offering”). On August 14, 2024, the Company reduced the amount under the Offering Agreement to $0 and suspended the ATM Offering. 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 September 30, 2025, the Company received aggregate net cash proceeds to the Company from the ATM Offering of approximately $6.1 million, with $4.7 million of net aggregate net cash proceeds received during the nine months ending September 30, 2025.
Cash Flow
The following table presents selected financial information and statistics for each of the periods shown below:
| September 30, 2025 |
December 31, 2024 |
|||||||
| Balance Sheet Data: |
||||||||
| Cash |
$ | 7,184 | $ | 1,443 | ||||
| Total assets |
14,996 | 3,651 | ||||||
| Convertible notes payable and accrued interest |
9,909 | 6,257 | ||||||
| Total liabilities |
40,751 | 26,874 | ||||||
| Total stockholders' deficit |
(25,755 | ) | (23,223 | ) | ||||
| Nine months ended September 30, |
||||||||
| 2025 |
2024 |
|||||||
| (Unaudited) |
||||||||
| Statement of Cash Flow Data: |
||||||||
| Net cash used in operating activities |
$ | (10,399 | ) | $ | (8,539 | ) | ||
| Net cash used in investing activities |
(2,561 | ) | — | |||||
| Net cash provided by financing activities |
18,701 | 5,590 | ||||||
| Net increase (decrease) in cash |
$ | 5,741 | $ | (2,949 | ) | |||
Operating Activities
During the nine months ended September 30, 2025, operating activities used approximately $10.4 million of cash, primarily resulting from a net loss of $29.0 million partially offset by net non-cash losses of $17.9 million, including $8.0 million in change in fair value of convertible promissory notes, $0.7 million of stock-based compensation and Common Stock issued in exchange for services, $4.2 million loss in convertible note conversion, $1.3 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, $8.5 million loss in change in fair value of warrant liabilities, $5.4 million in gain on exercise of warrants, and changes in operating assets and liabilities of less than $0.1 million.
During the nine months ended September 30, 2024, operating activities used approximately $8.5 million of cash, primarily resulting from a net loss of $16.0 million, partially offset by (a) net non-cash losses of $2.1 million, including a gain of $1.0 million in change in fair value of convertible promissory notes, and gain of $0.2 million in change in fair value of warrants, $0.4 million of stock-based compensation, $1.3 million of contract costs related to Alvogen termination, $0.8 million of default penalties, $0.5 million in debt issuance costs, and (b) changes in operating assets and liabilities of $5.4 million.
Investing Activities
Net cash used in investing activities was $2.6 million for the nine months ended September 30, 2025, compared to no cash used in investing activities during the comparable period in 2024. The outflows in the current period were primarily related to the cash consideration paid in connection with the acquisition of Dura, net of cash acquired. The Company did not incur any significant capital expenditure during either period.
Financing Activities
During the nine months ended September 30, 2025, financing activities provided $18.7 million of cash resulting from $9.4 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, $4.8 million in proceeds from issuance of Common Stock in connection with ATM offering, offset by $0.4 million in repayments of and by $0.2 million of proceeds from insurance notes, and $0.2 million in debt issuance costs due to the fair value election on Anson Notes.
During the nine months ended September 30, 2024, financing activities provided $5.6 million of cash resulting from $1.0 million in proceeds from issuance of Common Stock and warrants issued in a private placement, $4.9 million in proceeds from issuance of Common Stock and warrants, $2.9 million in proceeds from the Anson Notes, and $2.1 million from warrant proceeds offset by $4.8 million in repayments of the convertible notes.
Contractual Obligations and Commitments
See Note 10, Debt, and Note 11, Commitments and Contingencies, of the notes to the Company’s condensed consolidated financial statements as of and for the nine months ended September 30, 2025 included elsewhere in this report for further discussion of the Company’s commitments and contingencies.
Milestone Payments
Pursuant to the legal settlement with Sarah Herzog Memorial Hospital Ezrat Nashim (“SHMH”) in September 2018, which included the license of intellectual property rights from SHMH, an ongoing royalty of 1% to 2.5% of NRX-101 gross sales is due to SHMH, together with milestone payments of $0.3 million, upon completion of phase 3 trials and commercial sale of NRX-101. The milestone payments for developmental and commercial milestones range from $0.1 million to $0.8 million. Annual maintenance fees are up to $0.2 million.
Dura Acquisition
Under Dura Definitive Purchase Agreement, The Company may be required to pay up to $3.0 million in contingent earn-out payments based on EBITDA performance during the first three years following Closing. Payments are subject to the Seller’s continued employment and are prorated based on actual results achieved. The purchase price is also subject to customary post-closing adjustments for working capital, cash, and indebtedness.
Off-Balance Sheet Arrangements
The Company is not party to any off-balance sheet transactions. The Company has no guarantees or obligations other than those which arise out of normal business operations.
Critical Accounting Policies and Significant Judgments and Estimates
The Company's management’s discussion and analysis of its financial condition and results of operations is based on its financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”). The preparation of these financial statements requires NRx to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the balance sheet and the reported amounts of expenses during the reporting period. In accordance with GAAP, NRx evaluates its estimates and judgments on an ongoing basis. The most critical estimates relate to stock-based compensation, the valuation of warrants, and the valuation of convertible notes payable. NRx bases its estimates and assumptions on current facts, historical experiences, and various other factors that NRx believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
The Company defines its critical accounting policies as those accounting principles that require it to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on its financial condition and results of operations, as well as the specific manner in which the Company applies those principles. While its significant accounting policies are more fully described in Note 3 to its financial statements, the Company believes the following are the critical accounting policies used in the preparation of its financial statements that require significant estimates and judgments.
Stock-based Compensation
We measure stock option awards granted to employees and directors based on the fair value of the award on the date of the grant and recognize compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. For restricted stock awards, the grant date fair value is the fair market value per share as of the grant date based on the closing trading price for the Company’s stock. The straight-line method of expense recognition is applied to awards with service-only conditions. We account for forfeitures as they occur.
We estimate the fair value of each stock option award using the Black-Scholes option-pricing model, which uses as inputs the fair value of our Common Stock and assumptions we make for the volatility of our Common Stock, the expected term of our stock-based awards, the risk-free interest rate for a period that approximates the expected term of our stock-based awards, and our expected dividend yield. Therefore, we estimate our expected volatility based on the implied volatility of publicly traded warrants on our Common Stock and historical volatility of a set of our publicly traded peer companies. We estimate the expected term of our options using the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that we have never paid cash dividends on Common Stock and do not expect to pay any cash dividends in the foreseeable future.
The assumptions used in determining the fair value of stock-based awards represent reasonable estimates, but the estimates involve inherent uncertainties and the application of our judgment. As a result, if factors change and we use significantly different assumptions or estimates, our stock-based compensation expense could be materially different in the future.
Warrant Liabilities
We account for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own Common Stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, or date of modification, and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The fair value of the Private Placement Warrants, Anson Warrants, Consideration Warrants, and Anson Registered Direct Offering Warrants were estimated using a Black-Scholes valuation approach and the fair value of the Substitute Warrants was estimated using a modified Black Scholes valuation approach which applies a probability factor based on the earnout cash milestone and earnout shares milestone probabilities of achievement at each reporting period.
Convertible Notes Payable
As permitted under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 825, Financial Instruments (“ASC 825”), the Company elects to account for its convertible promissory notes, which meets the required criteria, at fair value at inception and at each subsequent reporting date. Subsequent changes in fair value are recorded as a component of non-operating loss in the condensed consolidated statements of operations. As a result of electing the fair value option, direct costs and fees related to the convertible promissory notes are expensed as incurred.
The Company estimates the fair value of the convertible notes payable using a Monte Carlo simulation model, which uses as inputs the fair value of our Common Stock and estimates for the equity volatility and volume volatility of our Common Stock, the time to expiration (i.e. expected termination date) of the convertible note, the risk-free interest rate for a period that approximates the time to expiration, and probability of default. Therefore, we estimate our expected future equity and volume volatility based on the historical volatility of both our Common Stock utilizing a lookback period consistent with the time to expiration. The time to expiration is based on the contractual maturity date, giving consideration to the mandatory and potential accelerated redemptions beginning six months from the issuance date. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of measurement for time periods approximately equal to the time to expiration. Probability of default is estimated using Bloomberg's Default Risk function which uses our financial information to calculate a default risk specific to the Company.
The assumptions used in determining the fair value of the convertible note payable represent reasonable estimates, but the estimates involve inherent uncertainties and the application of our judgment. As a result, if factors change and we use significantly different assumptions or estimates, the change in fair value of the convertible note payable recorded to other (income) expense could be materially different in the future.
Purchase Price Allocation
We account for business combinations in accordance with ASC Topic 805 Business Combinations, which requires that the assets acquired and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date and that the excess of consideration transferred over the fair value of net identifiable assets be recorded as goodwill.
The allocation of the purchase price to tangible assets (clinic equipment, leasehold improvements) and identifiable intangible assets (e.g., contracts, clinic trade names) and liabilities assumed (e.g., assumed leases, employee benefit obligations) is based on management’s estimate of fair value as of the acquisition date. This allocation process is considered a critical accounting estimate due to the significant judgments and assumptions inherent in determining the estimated fair values, including the selection of valuation methods (e.g., relief from royalty, multi-period excess earnings, replacement cost), discount rates, expected future cash flows, attrition rates, and useful lives of intangible assets. For the Dura acquisition, the estimated useful lives of acquired intangible assets ranged from 3 to 8 years, and discount rates applied ranged from 12% to 15%. Subsequent adjustments, within the one-year measurement period, may be made as additional information becomes available regarding facts and circumstances that existed at the acquisition date.
Goodwill
Goodwill recorded in connection with Dura acquisitions is attributable to the assembled workforce, anticipated growth in the Florida region, and synergies expected from integrating the clinics into our existing operations. Goodwill is not amortized but is subject to annual impairment testing and more frequently if indicators of impairment exist. We test goodwill for impairment for its reporting units on an annual basis, or when events occur, or when circumstances indicate the fair value of a reporting unit is below its carrying value.
We perform our annual goodwill impairment assessment on December 31st of each year or as impairment indicators dictate.
When evaluating the potential impairment of goodwill, management first assess a range of qualitative factors, including but not limited to, macroeconomic conditions, industry conditions, the competitive environment, changes in the market for our products and services, regulatory and political developments, entity specific factors such as strategy and changes in key personnel, and the overall financial performance for each of our reporting units. If, after completing this assessment, it is determined that it is more likely than not that the fair value of a reporting unit is less than its carrying value, we then proceed to the impairment testing methodology using an appropriate valuation method.
We compare the carrying value of the reporting unit, including goodwill, with its fair value, as determined by its estimated discounted cash flows. If the carrying value of a reporting unit exceeds its fair value, then the amount of impairment to be recognized is recognized as the amount by which the carrying amount exceeds the fair value.
When required, we may arrive at our estimates of fair value using a discounted cash flow methodology which includes estimates of future cash flows to be generated by specifically identified assets, as well as selecting a discount rate to measure the present value of those anticipated cash flows. Estimating future cash flows requires significant judgment and includes making assumptions about projected growth rates, industry-specific factors, working capital requirements, weighted average cost of capital, and current and anticipated operating conditions. The use of different assumptions or estimates for future cash flows could produce different results.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a smaller reporting company, we are not required to provide the information required by this Item.
Item 4. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as such term is defined under Rule 13a-15(e) promulgated under the Exchange Act, designed to ensure that information required to be disclosed in our reports filed pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate to allow timely decisions regarding required disclosures.
In designing and evaluating the disclosure controls and procedures, we recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and we were required to apply our judgment in evaluating the cost-benefit relationship of possible controls and procedures. We have carried out an evaluation as of September 30, 2025 under the supervision, and with the participation, of our management, including our Chief Executive Officer (who serves as our principal executive officer) and our Chief Financial Officer (who serves as our principal financial officer), of the effectiveness of the design and operation of our disclosure controls and procedures.
Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of September 30, 2025 in providing reasonable assurance of achieving the desired control objectives.
(b) Changes in Internal Control Over Financial Reporting
There were no changes in the Company’s internal controls over financial reporting that occurred during the three months ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company continues to review its disclosure controls and procedures, including its internal control over financial reporting, and may from time to time make changes aimed at enhancing their effectiveness and to ensure that the Company’s systems evolve with its business.
PART II – OTHER INFORMATION
Item 1. Legal Proceedings.
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. See Note 11, Commitments and Contingencies, of the notes to the Company’s unaudited condensed consolidated financial statements as of and for the three and nine months ended September 30, 2025 (“Note 11”) included elsewhere in this report for further discussion of certain legal proceedings in which we are involved. Other than as set forth below and/or in Note 11, there are no additional pending or threatened legal proceedings at this time.
On May 9, 2025, Hope Therapeutics, Inc. entered into an Asset Purchase and Contribution Agreement (the “Kadima Purchase 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, 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 the matter has entered arbitration. At this stage of the arbitration, it is too early to determine if the matter would reasonably be expected to have a material adverse effect on our financial condition.
Item 1A. Risk Factors
We have disclosed the risk factors that materially affect our business, financial condition or results of operations under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 14, 2025 (the “2024 Form 10-K”). Except as set forth below, there have been no material changes to the Risk Factors disclosed in Part I, Item 1A, Risk Factors, of the Company's 2024 Form 10-K.
There is no assurance that the anticipated acquisition of Kadima (as defined below) will be completed or that the Company will realize the anticipated benefits from the acquisition.
On May 9, 2025, HOPE entered into an Asset Purchase and Contribution Agreement (the “Kadima Purchase 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, certain assets of Kadima, subject to the satisfaction of certain closing conditions (the “Kadima Acquisition”). As of the date of this Quarterly Report on Form 10-Q, the parties have not closed the Kadima Acquisition and the matter has entered arbitration. At this stage of the arbitration, it is too early to determine if the matter would reasonably be expected to have a material adverse effect on our financial condition. Even if the transactions contemplated by the Kadima Purchase Agreement are completed, the acquisition of the assets being purchased thereunder may not materialize into revenue and generate the financial and strategic benefits the Company expected. The failure to close the Kadima Acquisition would negatively impact the Company’s revenues and return on investment. In addition, should the Kadima Acquisition be consummated, the Company may face operational challenges and unforeseen liabilities that may negatively impact its business.
The Company may not realize the anticipated benefits from its acquisition of Dura and Cohen, which could adversely affect stockholder value.
The Company recently completed the acquisition of Dura and Cohen. However, there can be no assurance that the Company will be able to successfully integrate Dura’s and Cohen’s operations, personnel, or technologies into its business in a timely or cost-effective manner, or at all. The anticipated benefits of these acquisitions, including expected revenue growth, operational synergies, and enhanced market opportunities, may not be achieved to the extent expected, or may take longer than anticipated to realize. In addition, unforeseen liabilities, increased expenses, operational challenges, or the diversion of management’s attention could negatively impact the Company’s business following the acquisition. If the Company is unable to achieve the intended strategic or financial benefits of these acquisitions, the Company’s business, financial condition, results of operations, and stockholder value could be adversely affected.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
No unregistered sales of equity securities occurred during the three months ended September 30, 2025, that were not previously reported.
Item 3. Defaults Upon Senior Securities
No defaults upon senior securities occurred during the three months ended September 30, 2025, that were not previously reported.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
of our directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended September 30, 2025, as such terms are defined under Item 408(a) of Regulation S-K. Additionally, we did not adopt or terminate a Rule 10b5–1 trading arrangement during the quarter ended September 30, 2025.
Item 6. Exhibits
| Exhibit Number |
Description |
|
| 31.1* |
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
| 31.2* |
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
| 32.1** |
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
| 32.2** |
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
| 101† |
Interactive data files pursuant to Rule 405 of Regulation S-T formatted in Inline XBRL: (i) Condensed Consolidated Balance Sheets; (ii) Unaudited Condensed Consolidated Statements of Operations; (iii) Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit); (iv) Unaudited Condensed Consolidated Statements of Cash Flows; and (v) Notes to Unaudited Financial Statements. |
|
| 104 |
Cover Page Interactive Data File (formatted in iXBRL and contained in Exhibit 101) |
| * |
Filed herewith. |
| ** |
This certification is being furnished solely to accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
| † |
In accordance with Rule 406T of Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q is deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act, is deemed not filed for purposes of section 18 of the Exchange Act, and otherwise is not subject to liability under these sections. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| NRX PHARMACEUTICALS, INC. |
||
| Date: November 14, 2025 |
By: |
/s/ Jonathan Javitt |
| Chairman and Interim Chief Executive Officer |
||
| (Principal Executive Officer) |
||
FAQ
How did NRX Pharmaceuticals (NRXP) perform financially for the nine months ended September 30, 2025?
For the nine months ended September 30, 2025, NRx Pharmaceuticals reported a net loss of approximately
What is NRX Pharmaceuticals' cash position and liquidity outlook as of Q3 2025?
As of September 30, 2025, the company had cash and cash equivalents of
What new revenue did HOPE and the Dura acquisition contribute to NRXP in Q3 2025?
Following the acquisition of Dura Medical on September 8, 2025, NRx generated initial patient service revenue of approximately
What capital raises did NRX Pharmaceuticals complete in 2025 so far?
NRx completed a registered direct offering in January 2025 of 1,215,278 shares at
What regulatory milestones did NRXP achieve for NRX-100 and NRX-101?
NRx received fast-track designation expansion for NRX-100 for all indications and types of depression and related disorders, re-filed an ANDA for preservative-free ketamine with an FDA communication that did not identify major deficiencies, filed a Commissioner’s National Priority Voucher application, and submitted manufacturing (module 3) data to support an NDA for NRX-101 in suicidal bipolar depression with akathisia.
Does NRX Pharmaceuticals have any debt or warrant-related exposures investors should understand?
Yes. As of September 30, 2025, NRx reported convertible note payable and accrued interest, current, of
