[10-Q] NRX Pharmaceuticals, Inc. Quarterly Earnings Report
NRX Pharmaceuticals (NRXP) reported interim 10-Q detail showing two lead drug candidates: NRX-100 (preservative-free ketamine IV) and NRX-101 (oral D-cycloserine+lurasidone). NRX-100 submitted for FDA review with Priority Review requested and first agency response received August 13, 2025; the company seeks regulatory approvals while pursuing potential clinical facility revenue through its HOPE subsidiary.
The company had 19,473,588 shares outstanding at June 30, 2025, no revenues and expects operating losses through 2025. Financing activity included a Registered Direct offering raising net proceeds of approximately $3.255 million, At-the-Market sales of common stock totaling about $1.04 million during the period, and multiple convertible Anson Notes with conversions that issued significant common shares. The company recorded substantial non-cash losses: $5.6 million and $6.5 million fair value losses on Anson notes and $6.4 million/$3.5 million change-in-fair-value losses on warrant liabilities for the three- and six-month periods, respectively. A terminated license with Alvogen left a $4.7 million refund liability and no anticipated revenue from that agreement.
NRX Pharmaceuticals (NRXP) ha reso noti dettagli provvisori del 10-Q che evidenziano due principali candidati farmaceutici: NRX-100 (ketamina endovenosa senza conservanti) e NRX-101 (associazione orale di D-cicloserina e lurasidone). La domanda per NRX-100 è stata presentata alla FDA con richiesta di Priority Review; la prima risposta dell’agenzia è pervenuta il 13 agosto 2025. La società cerca l’autorizzazione regolatoria mentre esplora ricavi potenziali da strutture cliniche tramite la sua controllata HOPE.
Al 30 giugno 2025 la società aveva 19.473.588 azioni in circolazione, nessun ricavo e prevede perdite operative per tutto il 2025. Le attività di finanziamento includono un Registered Direct offering che ha portato proventi netti di circa $3,255 milioni, vendite “At-the-Market” di azioni ordinarie per circa $1,04 milioni nel periodo, e più note convertibili Anson con conversioni che hanno emesso un numero rilevante di azioni ordinarie. La società ha registrato perdite non monetarie significative: perdite per la fair value di $5,6 milioni e $6,5 milioni sulle note Anson e perdite da variazione del fair value delle passività da warrant di $6,4 milioni e $3,5 milioni rispettivamente per i periodi di tre e sei mesi. Una licenza risolta con Alvogen ha lasciato una passività di rimborso di $4,7 milioni e non si prevedono ricavi da quell’accordo.
NRX Pharmaceuticals (NRXP) presentó detalles provisionales del 10-Q que muestran dos candidatos principales: NRX-100 (ketamina IV sin conservantes) y NRX-101 (D-cicloserina oral + lurasidona). NRX-100 fue sometido a revisión por la FDA con solicitud de Priority Review; la primera respuesta de la agencia se recibió el 13 de agosto de 2025. La compañía busca aprobaciones regulatorias mientras persigue posibles ingresos por instalaciones clínicas a través de su filial HOPE.
Al 30 de junio de 2025 la compañía tenía 19.473.588 acciones en circulación, sin ingresos y espera pérdidas operativas durante 2025. Las actividades de financiamiento incluyeron una Registered Direct offering que generó ingresos netos de aproximadamente $3,255 millones, ventas At-the-Market de acciones por un total de alrededor de $1,04 millones durante el período, y varias notas convertibles Anson cuyas conversiones emitieron un número significativo de acciones comunes. La compañía registró pérdidas no monetarias sustanciales: pérdidas por valor razonable de $5,6 millones y $6,5 millones en las notas Anson y pérdidas por cambio en el valor razonable de pasivos por warrants de $6,4 millones y $3,5 millones para los periodos de tres y seis meses, respectivamente. Una licencia terminada con Alvogen dejó una obligación de reembolso de $4,7 millones y no se esperan ingresos de ese acuerdo.
NRX Pharmaceuticals (NRXP)는 10-Q 중간보고 세부사항을 공개했으며, 두 가지 주요 후보 약물을 공개했습니다: NRX-100(보존제가 없는 정맥주사 케타민)과 NRX-101(경구용 D-사이클로세린+루라시돈). NRX-100은 FDA 심사를 제출했고 Priority Review를 요청했으며, 기관의 첫 응답은 2025년 8월 13일에 수령했습니다. 회사는 규제 승인 획득을 추진하는 동시에 자회사 HOPE를 통해 임상 시설 관련 잠재적 수익을 모색하고 있습니다.
2025년 6월 30일 기준 발행주식수는 19,473,588주였고, 매출은 없으며 2025년 동안 영업손실이 지속될 것으로 예상됩니다. 자금 조달 활동으로는 약 $3.255백만의 순수익을 확보한 Registered Direct offering, 기간 중 약 $1.04백만의 보통주 At-the-Market 매출, 그리고 전환으로 상당한 보통주를 발행한 여러 건의 Anson 전환사채가 있었습니다. 회사는 상당한 비현금 손실을 기록했는데, Anson 채권에 대한 공정가치 손실이 $5.6백만, $6.5백만이고, 워런트 부채의 공정가치 변동 손실이 3개월/6개월 기간 각각 $6.4백만/$3.5백만입니다. Alvogen과의 종료된 라이선스 계약으로 $4.7백만의 환불부채가 남아 있으며 해당 계약에서의 수익은 예상되지 않습니다.
NRX Pharmaceuticals (NRXP) a publié des détails intérimaires du 10-Q montrant deux principaux candidats-médicaments : NRX-100 (kétamine IV sans conservateurs) et NRX-101 (D-cyclosérine orale + lurasidone). NRX-100 a été soumis à la FDA avec une demande de Priority Review; la première réponse de l’agence a été reçue le 13 août 2025. La société recherche des autorisations réglementaires tout en poursuivant d’éventuels revenus liés à des installations cliniques via sa filiale HOPE.
Au 30 juin 2025, la société comptait 19 473 588 actions en circulation, aucun revenu et prévoit des pertes d’exploitation pour 2025. Les opérations de financement ont inclus une Registered Direct offering générant des produits nets d’environ 3,255 M$, des ventes At-the-Market d’actions ordinaires totalisant environ 1,04 M$ au cours de la période, et plusieurs billets convertibles Anson dont les conversions ont émis un nombre important d’actions ordinaires. La société a enregistré des pertes non monétaires substantielles : pertes de juste valeur de 5,6 M$ et 6,5 M$ sur les billets Anson et pertes liées au changement de juste valeur des passifs de bons de souscription de 6,4 M$ et 3,5 M$ sur les périodes de trois et six mois respectivement. Une licence résiliée avec Alvogen a laissé une dette de remboursement de 4,7 M$ et aucun revenu n’est attendu de cet accord.
NRX Pharmaceuticals (NRXP) veröffentlichte vorläufige 10-Q-Details, die zwei führende Kandidaten aufführen: NRX-100 (konservierungsmittelfreie Ketamin-Infusion) und NRX-101 (orale D-Cycloserin + Lurasidon). Für NRX-100 wurde ein FDA-Antrag gestellt mit Antrag auf Priority Review; die erste Rückmeldung der Behörde ging am 13. August 2025 ein. Das Unternehmen strebt behördliche Zulassungen an und prüft zugleich potenzielle Erlöse aus klinischen Einrichtungen über seine Tochtergesellschaft HOPE.
Zum 30. Juni 2025 hatte das Unternehmen 19.473.588 ausstehende Aktien, keine Einnahmen und erwartet operative Verluste bis Ende 2025. Zu den Finanzierungsmaßnahmen gehörten ein Registered Direct Offering mit Nettoerlösen von rund $3,255 Mio., At-the-Market-Verkäufe von Stammaktien in Höhe von etwa $1,04 Mio. im Berichtszeitraum sowie mehrere wandelbare Anson-Notes, deren Umwandlungen bedeutende Stammaktien ausgaben. Das Unternehmen verbuchte erhebliche nicht zahlungswirksame Verluste: Bewertungsverluste auf Anson-Notes in Höhe von $5,6 Mio. und $6,5 Mio. sowie Bewertungsänderungsverluste auf Wandeloptionsverbindlichkeiten von $6,4 Mio. bzw. $3,5 Mio. für die Drei- bzw. Sechsmonatszeiträume. Eine beendete Lizenzvereinbarung mit Alvogen hinterließ eine Rückzahlungsverpflichtung von $4,7 Mio. und es werden daraus keine Einnahmen erwartet.
- FDA submission activity for NRX-100 with Priority Review requested and a first response received on August 13, 2025
- Registered Direct offering raised net proceeds of approximately $3.255 million
- At-the-Market program reinstated and produced approximately $1.04 million net proceeds during the period
- Convertible note conversions reduced nominal outstanding debt balances through equity issuance
- No revenues and expectation to continue incurring operating losses through at least the remainder of 2025
- Significant fair value losses recorded: Anson notes losses of $5.6M and $6.5M during the three- and six-month periods, respectively
- Large warrant liability remeasurements producing losses of approximately $6.4M and $3.5M for the three- and six-month periods, respectively
- High cost of capital on certain tranches (effective interest rates reported as 4.6% and 45.7%) increasing financing burden
- Termination of Alvogen license created a $4.7M refund liability and eliminated anticipated revenue from that agreement
Insights
TL;DR Significant financing activity funded operations but produced large non-cash fair value losses and persistent cash burn, pressuring near-term financial stability.
The company shows active regulatory progress for NRX-100 and NRX-101, which is strategically important, but operationally NRXP remains pre-revenue and reliant on equity/debt financings. Recent convertible note conversions reduced nominal debt but generated dilution and recorded substantial losses from fair-value accounting of notes and derivative warrants. Effective interest rates reported include 4.6% and 45.7% for the Second and Third Tranche Notes, respectively, indicating costly capital. The terminated Alvogen license produced a $4.7 million refund liability and removed foreseeable revenue. Overall impact: material and negative to near-term equity holders.
TL;DR Governance shows active investor negotiations and equity-based compensation; key commercial agreements changed materially.
Board-approved financings, registered direct offerings, and multiple tranche note structures demonstrate management access to capital but also complex contractual features (conversion price floors, redemption obligations, and beneficial ownership limits) that increase dilution and contingent obligations. The termination of the Alvogen license and settlement payments tied to prior financings highlight contract and counterparty risk. Disclosure indicates reliance on future financings and regulatory outcomes, underscoring governance focus areas: capital structure management and milestone-driven vesting provisions.
NRX Pharmaceuticals (NRXP) ha reso noti dettagli provvisori del 10-Q che evidenziano due principali candidati farmaceutici: NRX-100 (ketamina endovenosa senza conservanti) e NRX-101 (associazione orale di D-cicloserina e lurasidone). La domanda per NRX-100 è stata presentata alla FDA con richiesta di Priority Review; la prima risposta dell’agenzia è pervenuta il 13 agosto 2025. La società cerca l’autorizzazione regolatoria mentre esplora ricavi potenziali da strutture cliniche tramite la sua controllata HOPE.
Al 30 giugno 2025 la società aveva 19.473.588 azioni in circolazione, nessun ricavo e prevede perdite operative per tutto il 2025. Le attività di finanziamento includono un Registered Direct offering che ha portato proventi netti di circa $3,255 milioni, vendite “At-the-Market” di azioni ordinarie per circa $1,04 milioni nel periodo, e più note convertibili Anson con conversioni che hanno emesso un numero rilevante di azioni ordinarie. La società ha registrato perdite non monetarie significative: perdite per la fair value di $5,6 milioni e $6,5 milioni sulle note Anson e perdite da variazione del fair value delle passività da warrant di $6,4 milioni e $3,5 milioni rispettivamente per i periodi di tre e sei mesi. Una licenza risolta con Alvogen ha lasciato una passività di rimborso di $4,7 milioni e non si prevedono ricavi da quell’accordo.
NRX Pharmaceuticals (NRXP) presentó detalles provisionales del 10-Q que muestran dos candidatos principales: NRX-100 (ketamina IV sin conservantes) y NRX-101 (D-cicloserina oral + lurasidona). NRX-100 fue sometido a revisión por la FDA con solicitud de Priority Review; la primera respuesta de la agencia se recibió el 13 de agosto de 2025. La compañía busca aprobaciones regulatorias mientras persigue posibles ingresos por instalaciones clínicas a través de su filial HOPE.
Al 30 de junio de 2025 la compañía tenía 19.473.588 acciones en circulación, sin ingresos y espera pérdidas operativas durante 2025. Las actividades de financiamiento incluyeron una Registered Direct offering que generó ingresos netos de aproximadamente $3,255 millones, ventas At-the-Market de acciones por un total de alrededor de $1,04 millones durante el período, y varias notas convertibles Anson cuyas conversiones emitieron un número significativo de acciones comunes. La compañía registró pérdidas no monetarias sustanciales: pérdidas por valor razonable de $5,6 millones y $6,5 millones en las notas Anson y pérdidas por cambio en el valor razonable de pasivos por warrants de $6,4 millones y $3,5 millones para los periodos de tres y seis meses, respectivamente. Una licencia terminada con Alvogen dejó una obligación de reembolso de $4,7 millones y no se esperan ingresos de ese acuerdo.
NRX Pharmaceuticals (NRXP)는 10-Q 중간보고 세부사항을 공개했으며, 두 가지 주요 후보 약물을 공개했습니다: NRX-100(보존제가 없는 정맥주사 케타민)과 NRX-101(경구용 D-사이클로세린+루라시돈). NRX-100은 FDA 심사를 제출했고 Priority Review를 요청했으며, 기관의 첫 응답은 2025년 8월 13일에 수령했습니다. 회사는 규제 승인 획득을 추진하는 동시에 자회사 HOPE를 통해 임상 시설 관련 잠재적 수익을 모색하고 있습니다.
2025년 6월 30일 기준 발행주식수는 19,473,588주였고, 매출은 없으며 2025년 동안 영업손실이 지속될 것으로 예상됩니다. 자금 조달 활동으로는 약 $3.255백만의 순수익을 확보한 Registered Direct offering, 기간 중 약 $1.04백만의 보통주 At-the-Market 매출, 그리고 전환으로 상당한 보통주를 발행한 여러 건의 Anson 전환사채가 있었습니다. 회사는 상당한 비현금 손실을 기록했는데, Anson 채권에 대한 공정가치 손실이 $5.6백만, $6.5백만이고, 워런트 부채의 공정가치 변동 손실이 3개월/6개월 기간 각각 $6.4백만/$3.5백만입니다. Alvogen과의 종료된 라이선스 계약으로 $4.7백만의 환불부채가 남아 있으며 해당 계약에서의 수익은 예상되지 않습니다.
NRX Pharmaceuticals (NRXP) a publié des détails intérimaires du 10-Q montrant deux principaux candidats-médicaments : NRX-100 (kétamine IV sans conservateurs) et NRX-101 (D-cyclosérine orale + lurasidone). NRX-100 a été soumis à la FDA avec une demande de Priority Review; la première réponse de l’agence a été reçue le 13 août 2025. La société recherche des autorisations réglementaires tout en poursuivant d’éventuels revenus liés à des installations cliniques via sa filiale HOPE.
Au 30 juin 2025, la société comptait 19 473 588 actions en circulation, aucun revenu et prévoit des pertes d’exploitation pour 2025. Les opérations de financement ont inclus une Registered Direct offering générant des produits nets d’environ 3,255 M$, des ventes At-the-Market d’actions ordinaires totalisant environ 1,04 M$ au cours de la période, et plusieurs billets convertibles Anson dont les conversions ont émis un nombre important d’actions ordinaires. La société a enregistré des pertes non monétaires substantielles : pertes de juste valeur de 5,6 M$ et 6,5 M$ sur les billets Anson et pertes liées au changement de juste valeur des passifs de bons de souscription de 6,4 M$ et 3,5 M$ sur les périodes de trois et six mois respectivement. Une licence résiliée avec Alvogen a laissé une dette de remboursement de 4,7 M$ et aucun revenu n’est attendu de cet accord.
NRX Pharmaceuticals (NRXP) veröffentlichte vorläufige 10-Q-Details, die zwei führende Kandidaten aufführen: NRX-100 (konservierungsmittelfreie Ketamin-Infusion) und NRX-101 (orale D-Cycloserin + Lurasidon). Für NRX-100 wurde ein FDA-Antrag gestellt mit Antrag auf Priority Review; die erste Rückmeldung der Behörde ging am 13. August 2025 ein. Das Unternehmen strebt behördliche Zulassungen an und prüft zugleich potenzielle Erlöse aus klinischen Einrichtungen über seine Tochtergesellschaft HOPE.
Zum 30. Juni 2025 hatte das Unternehmen 19.473.588 ausstehende Aktien, keine Einnahmen und erwartet operative Verluste bis Ende 2025. Zu den Finanzierungsmaßnahmen gehörten ein Registered Direct Offering mit Nettoerlösen von rund $3,255 Mio., At-the-Market-Verkäufe von Stammaktien in Höhe von etwa $1,04 Mio. im Berichtszeitraum sowie mehrere wandelbare Anson-Notes, deren Umwandlungen bedeutende Stammaktien ausgaben. Das Unternehmen verbuchte erhebliche nicht zahlungswirksame Verluste: Bewertungsverluste auf Anson-Notes in Höhe von $5,6 Mio. und $6,5 Mio. sowie Bewertungsänderungsverluste auf Wandeloptionsverbindlichkeiten von $6,4 Mio. bzw. $3,5 Mio. für die Drei- bzw. Sechsmonatszeiträume. Eine beendete Lizenzvereinbarung mit Alvogen hinterließ eine Rückzahlungsverpflichtung von $4,7 Mio. und es werden daraus keine Einnahmen erwartet.
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 August 14, 2025, the registrant had
TABLE OF CONTENTS
| Page |
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| PART I - FINANCIAL INFORMATION |
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| ITEM 1. |
Financial Statements |
|
| Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024 |
3 | |
| Unaudited Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024 |
4 | |
| Unaudited Condensed Consolidated Statements of Changes in Stockholders' Deficit for the three and six months ended June 30, 2025 and 2024 |
5 | |
| Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024 |
6 | |
| Notes to Unaudited Condensed Consolidated Financial Statements |
7 | |
| ITEM 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
32 |
| ITEM 3. |
Quantitative and Qualitative Disclosures About Market Risk |
43 |
| ITEM 4. |
Controls and Procedures |
44 |
| PART II - OTHER INFORMATION |
||
| ITEM 1. |
Legal Proceedings |
44 |
| ITEM 1A. |
Risk Factors |
45 |
| ITEM 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
45 |
| ITEM 3. |
Defaults Upon Senior Securities |
46 |
| ITEM 4. |
Mine Safety Disclosures |
46 |
| ITEM 5. |
Other Information |
46 |
| ITEM 6. |
Exhibits |
46 |
| SIGNATURES |
47 | |
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
NRX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Other assets | ||||||||
| 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 – short term | ||||||||
| Insurance loan payable | ||||||||
| Warrant liabilities | ||||||||
| Total current liabilities | ||||||||
| Convertible note payable and accrued interest – long term | ||||||||
| Total liabilities | $ | $ | ||||||
| Commitments and Contingencies (Note 8) | ||||||||
| Stockholders’ deficit: | ||||||||
| Preferred stock, $ par value, shares authorized; | $ | $ | ||||||
| Series A convertible preferred stock, $ par value, shares authorized; shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Common stock, $ par value, shares authorized; and shares issued and outstanding at June 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 June 30, | Six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expense: | ||||||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Settlement expense | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other (income) expense: | ||||||||||||||||
| Interest income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest expense | ||||||||||||||||
| Change in fair value of convertible note payable | ||||||||||||||||
| Change in fair value of warrant liabilities | ( | ) | ( | ) | ||||||||||||
| Convertible note default penalty | ||||||||||||||||
| Loss on issuance of the Registered Direct Offering (see Note 9) | ||||||||||||||||
| Loss on Consideration Shares and Warrants (see Note 9) | ||||||||||||||||
| Loss on convertible note conversions | ||||||||||||||||
| Total other expenses, net | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average common shares 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)
| Series A Preferred Stock | Common Stock | Additional Paid-in- | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Loss | Deficit | |||||||||||||||||||||||||
| Balance - December 31, 2024 | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||
| Shares issued as conversion of principal and interest for convertible note | ||||||||||||||||||||||||||||||||
| Shares issued in connection with the Registered Direct offering, net of $ issuance costs | ||||||||||||||||||||||||||||||||
| Fair value allocation of warrants issued with Registered Direct offering | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Amortization of deferred offering costs | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Consideration Shares issued as a result of repricing (See Note 9) | ||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | ||||||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance – March 31, 2025 | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||
| Shares issued in exchange for services | ||||||||||||||||||||||||||||||||
| Shares issued as conversion of principal and interest for convertible note | ||||||||||||||||||||||||||||||||
| Amortization of deferred offering costs | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| At-the-market "ATM" offering, net of offering costs of $ | ||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | ||||||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance – June 30, 2025 | $ | $ | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||||||||||||||||
| Series A Preferred Stock | Common Stock | Additional Paid-in- | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Loss | Deficit | |||||||||||||||||||||||||
| Balance December 31, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
| 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 6) | — | — | ||||||||||||||||||||||||||||||
| 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 | — | — | — | — | — | — | ||||||||||||||||||||||||||
| Contract cost related to Alvogen termination (see Note 6) | — | — | ||||||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance - June 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)
| Six months ended June 30, |
||||||||
| 2025 |
2024 |
|||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||||
| Net loss |
$ | ( |
) | $ | ( |
) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
| Depreciation expense |
||||||||
| Stock-based compensation |
||||||||
| Common stock issued in exchange for services |
||||||||
| Change in fair value of warrant liabilities |
( |
) | ||||||
| Change in fair value of convertible promissory note |
||||||||
| Loss on Consideration Shares and Warrants |
||||||||
| Loss on issuance of Registered Direct Offering |
||||||||
| Loss on convertible notes conversion |
||||||||
| Expense for debt issuance costs due to fair value election on Anson Notes |
||||||||
| Warrant issuance costs related to Alvogen termination |
||||||||
| Convertible note default penalty |
||||||||
| Changes in operating assets and liabilities: |
||||||||
| Prepaid expense and other assets |
( |
) | ||||||
| Accounts payable |
( |
) | ||||||
| Insurance loan payable |
||||||||
| Accrued expense and other liabilities |
( |
) | ||||||
| Net cash used in operating activities |
( |
) | ( |
) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES |
||||||||
| Repayment of convertible note |
( |
) | ||||||
| Repayment of insurance loan |
( |
) | ||||||
| Expense for debt issuance costs due to fair value election on Anson Notes |
( |
) | ||||||
| Proceeds from issuance of insurance loan |
||||||||
| Proceeds from Anson convertible notes, net of OID |
||||||||
| Proceeds from issuance of common stock and warrants issued in Registered Direct offering, net of issuance costs |
||||||||
| Proceeds from ATM offering, net of offering costs |
||||||||
| Proceeds from issuance of common stock and warrants, net of issuance costs |
||||||||
| 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 |
$ | $ | ||||||
| Conversion of Series A preferred stock into common stock |
$ | $ | ||||||
| Amortization of deferred offering costs to additional paid-in-capital |
$ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
NRX PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2025
(Unaudited)
1. Organization
The Business
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”, “we”, “us” or “our”) is a clinical-stage bio-pharmaceutical company which develops and will distribute, through its wholly-owned operating subsidiary, NeuroRx, Inc., (“NeuroRx”), novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, and post-traumatic stress disorder (“PTSD”) and schizophrenia. All of our current drug development activities are focused drugs that modulate on the N-methyl-D-aspartate (“NMDA”) receptor in the brain and nervous system, a neurochemical pathway that has been disclosed in detail in our annual filings. The Company has two lead drug candidates – NRX-100, a preservative-free formulation of ketamine for intravenous infusion, and NRX-101, an oral fixed dose combination of D-cycloserine and lurasidone. NRX-100 and NRX-101 are in the process of submission for Food and Drug Administration (“FDA”) approval as follows:
| 1. | An Abbreviated New Drug Application (“ANDA”) for NRX-100 was filed, with Priority Review requested, during the second quarter of 2025 with a first response received August 13, 2025. |
| 2. | A New Drug Application (“NDA”) for NRX-100, originally initiated during the fourth quarter of 2024, is expected to be completed in September 2025. This follows the Company’s successful application for a waiver under the Prescription Drug User Fee Act ("PDUFA"), which is expected to save the Company approximately $ |
| 3. | An NDA filing for NRX-101 has been initiated with the transmission of the Module 3 manufacturing file to publishing. The drug was previously awarded Breakthrough Therapy Designation and accordingly the Company is requesting rolling review of the NDA. Breakthrough Therapy Designation is granted by the FDA to facilitate the development, and expedite the review of drugs to treat serious conditions meet an unmet medical need, and have demonstrated preliminary evidence of efficacy as determined by the FDA. The Company anticipates decision dates from the FDA for both its NDA applications potentially as early as year-end 2025 (NRX-100) and the first quarter of 2026 (NRX-101). |
In February 2024, NRx incorporated HOPE Therapeutics, Inc. (“HOPE”), a medical care delivery organization focused on providing cutting-edge, comprehensive interventional psychiatric treatment of the above conditions with the most effective treatments available, including NMDA-targeted and other neuroplastic drugs, such as ketamine, Spravato and NRX-101, neuromodulatory devices, such as Transcranial Magnetic Stimulation (“TMS”), digital therapeutics, and medication management.
NeuroRx is organized as a traditional research and development (“R&D”) company, whereas HOPE is organized as a medical care delivery company intended to own and/or operate clinics that serve patients with suicidal depression, PTSD, and other serious Central Nervous System (“CNS”) disorders. Management’s plan, through the establishment of HOPE, is to transform NRx from a pre-revenue biotechnology company to a revenue-generating enterprise that continues to develop life-saving drugs and technologies through NeuroRx, while also treating patients through HOPE.
During the second quarter of 2025 and in the subsequent period, key achievements by the Company in support of its overall mission to improve and save the lives of patients affected by central nervous system disorders including suicidal depression, chronic pain, post-traumatic stress disorder and schizophrenia include the following:
Drug Development
| ● | Grant of Fast Track Designation for NRX-100 from the FDA for all indications and types of depression and related disorders based on its potential to satisfy an unmet medical need. This designation represents an approximately 10-fold expansion of the addressable market to 13 million Americans, compared to the original Fast Track Designation issued in 2017 for bipolar depression alone. The Designation letter contains a specific finding that NRX-100 addresses an “unmet medical need.” This is a specific qualifying requirement for the Commissioner’s National Priority Voucher Program. | |
| ● | Filing of an ANDA for NRX-100 (preservative-free intravenous ketamine). | |
| ● | Filing of Commissioner’s National Priority Voucher application for intravenous ketamine (NRX-100). | |
| ● | Submission of stability data for NRX-100 to the manufacturing data on file with FDA sufficient to support three years of room temperature shelf stability for NRX-100. | |
| ● | Submission of draft labeling for NRX-100 in the treatment of suicidal depression based on the Fast Track Designation received. | |
| ● | Completion of a toxicology assessment of Benzethonium Chloride, documenting its lack of “Generally Recognized as Safe” (GRAS) status and lack of safety data to support its use in intravenous presentations of ketamine. | |
| ● | Filing of a Citizen’s Petition with the U.S. Food and Drug Administration to seek the removal of benzethonium chloride, a toxic preservative, from all ketamine products for intravenous administration. | |
| ● | Filing of a patent application for NRX-100, the Company’s proprietary preservative-free formulation of intravenous ketamine. | |
| ● | Receipt of filing fee waiver from the FDA for NRX-100. | |
| ● | Filing of module 3 manufacturing data to support a New Drug Application for NRX-101 in the treatment of patients with suicidal bipolar depression and akathisia despite treatment with already-approved medication. |
Interventional Psychiatry Clinics (HOPE Therapeutics)
| ● | Execution of definitive Purchase Agreement and receipt of final regulatory clearance from Florida’s Agency for Health Care Administration (“ACHA”) to proceed with closing the acquisition of Dura Medical. | |
| ● | Execution of binding letter of intent to acquire the assets of NeuroSpa TMS of Tampa, FL. | |
| ● | Execution of a binding letter of intent to acquire a | |
| ● | Receipt of approval pending legal stipulations for $ | |
| ● | Execution of a definitive purchase agreement, subject to standard closing conditions and agreement between the parties regarding the resolution of ongoing discussions, to purchase the non-clinical assets of Kadima Neuropsychiatry Institute. | |
| ● | Execution of a non-binding term sheet for a strategic investment from a global medical device manufacturer into HOPE. |
2. Going Concern
These condensed consolidated financial statements have been prepared on a going concern basis which contemplates the realization of assets and settlement of liabilities and commitments in the normal course of business. Since inception, the Company has experienced net losses and negative cash flows from operations each fiscal year and has a working capital deficit at June 30, 2025. The Company has
As of June 30, 2025, the Company had $
Pursuant to the Purchase Agreement, on January 28, 2025 (the “Third Closing Date”), the Company sold a total of $
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 year end and to finance submission of FDA New Drug Applications for NRX-100 and NRX-101. 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 shareholders. The Company cannot make any assurances that additional financing will be available to it and, if available, on acceptable terms, or that it will be able to refinance its existing debt obligations which could negatively impact the Company’s business and operations and could also lead to a reduction in the Company’s operations. The Company will continue to carefully monitor the impact of its continuing operations on the Company’s working capital needs and debt repayment obligations. As such, the Company has concluded that substantial doubt exists regarding the Company’s ability to continue as a going concern for a period of at least twelve months from the date of issuance of these condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The 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.
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.
Use of Estimates
The preparation of condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in its condensed consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s condensed consolidated financial statements relate to the fair value of the convertible notes payable, fair value of warrant liabilities, fair value of stock options and warrants, fair value of the common stock shares granted for services, and the utilization of deferred tax assets. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Certain Risks and Uncertainties
The Company’s activities are subject to significant risks and uncertainties including the risk of failure to secure additional funding to properly execute the Company’s business plan. The Company is subject to risks that are common to companies in the pharmaceutical industry, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, reliance on third party manufacturers, protection of proprietary technology, and compliance with regulatory requirements.
Fair Value of Financial Instruments
FASB ASC Topic 820, Fair Value Measurements (“ASC 820”), provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes:
Level 1: Quoted prices in active markets for identical assets or liabilities.
Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. (Refer to Note 11)
Concentration of Credit Risk and Off-Balance Sheet Risk
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Cash equivalents are occasionally invested in certificates of deposit. The Company maintains each of its cash balances with high-quality and accredited financial institutions and accordingly, such funds are not exposed to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Deposits in financial institutions may, from time to time, exceed federally insured limits. As of June 30, 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.
Revenue Recognition
The Company accounts for revenue under FASB ASC Topic 606, Revenue for Contract with Customers (“ASC 606”) or other accounting standards for revenue not derived from customers. Arrangements may include licenses to intellectual property, research services and participation on joint research committees. The Company evaluates the promised goods or services to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, the Company considers the stage of research, the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property, and whether the promised goods or services are integral to or dependent on other promises in the contract. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, timelines and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract.
The Company enters into contractual arrangements that may include licenses to intellectual property and research and development services. When such contractual arrangements are determined to be accounted for in accordance with ASC 606, the Company evaluates the promised good or services to determine which promises, or group of promises, represent performance obligations. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, timelines and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract.
The License Agreement (the “License Agreement”) with Alvogen Pharma US, Inc., Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (collectively, “Alvogen”) (as further discussed in Note 6 below) was accounted for in accordance with ASC 606. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps:
| i. | identify the contract(s) with a customer; | |
| ii. | identify the performance obligations in the contract; | |
| iii. | determine the transaction price; | |
| iv. | allocate the transaction price to the performance obligations within the contract; and | |
| v. | recognize revenue when (or as) the entity satisfies a performance obligation. |
The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract to determine whether each promised good or service is a performance obligation. The promised goods or services in the Company’s arrangements typically consist of a license to intellectual property and research services. The Company may provide options to additional items in such arrangements, which are accounted for as separate contracts when the customer elects to exercise such options, unless the option provides a material right to the customer. Performance obligations are promises in a contract to transfer a distinct good or service to the customer that (i) the customer can benefit from on its own or together with other readily available resources, and (ii) is separately identifiable from other promises in the contract. Goods or services that are not individually distinct performance obligations are combined with other promised goods or services until such combined group of promises meet the requirements of a performance obligation.
The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable, or a combination of both. At contract inception for arrangements that include variable consideration, the Company estimates the probability and extent of consideration it expects to receive under the contract utilizing either the most likely amount method or expected amount method, whichever best estimates the amount expected to be received. The Company then considers any constraints on the variable consideration and includes in the transaction price variable consideration to the extent it is deemed probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
The Company then allocates the transaction price to each performance obligation based on the relative standalone selling price and recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
The Company records amounts as accounts receivable when the right to consideration is deemed unconditional. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded as deferred revenue.
The Company’s revenue arrangements may include the following:
Milestone Payments: At the inception of an agreement that includes milestone payments, the Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty.) The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Research Services: The Company incurred research costs in association with the License Agreement. After the First Milestone Payment (as defined in Note 6 below), the Company would have been reimbursed for certain costs incurred related to reasonable and documented out-of-pocket costs for clinical and non-clinical development activities. The Company would have recognized revenue for the reimbursed costs when the First Milestone Payment contingencies had been achieved and the Company had an enforceable claim to the reimbursed costs.
Research and Development Costs
Research and development expense consists primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in ongoing research and development efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are 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 of non-operating loss in the condensed consolidated statements of operations. The portion of total changes in fair value of the notes attributable to changes in instrument-specific credit risk are determined through specific measurement of periodic changes in the discount rate assumption exclusive of base market changes and are presented as a component of comprehensive income in the accompanying condensed consolidated statements of operations and comprehensive loss. As a result of electing the fair value option, direct costs and fees related to the issuance of the promissory notes are expensed as incurred.
The Company estimates the fair value of its notes payable using a Monte Carlo simulation model, which uses as inputs the fair value of its Common Stock and estimates for the equity volatility of its Common Stock, the time to expiration (i.e., expected term) of the note, the risk-free interest rate for a period that approximates the time to expiration, and probability of default. Therefore, the Company estimates its expected future equity volatility based on the historical volatility of its Common Stock price utilizing a lookback period consistent with the time to expiration. The time to expiration is based on the contractual maturity date, giving consideration to the redemption features embedded in the notes. The risk-free interest rate is determined based on the U.S. Treasury yield curve in effect at the time of measurement for time periods approximately equal to the time to expiration. Unless otherwise specified, the probability of default is estimated using Bloomberg’s Default Risk function which uses its financial information to calculate a default risk specific to the Company. Management believes those assumptions are reasonable but if these assumptions change, it could materially affect the fair value.
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 12 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.
| Six months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Stock options | ||||||||
| Restricted stock awards | ||||||||
| Common stock warrants | ||||||||
| Common shares issuable upon conversion of Anson Notes | ||||||||
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.
4. Prepaid Expense and Other Current Assets
Prepaid expense and other current assets consisted of the following at the dates indicated (in thousands):
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| Prepaid expense and other current assets: | ||||||||
| Prepaid insurance | $ | $ | ||||||
| Prepaid clinical development costs | ||||||||
| Other prepaid expense | ||||||||
| Total prepaid expense and other current assets | $ | $ | ||||||
5. Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following at the dates indicated (in thousands):
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| Accrued and other current liabilities: | ||||||||
| Refund liability (see Note 6) | $ | $ | ||||||
| Professional services | ||||||||
| Employee costs | ||||||||
| Accrued research and development expense | ||||||||
| Other accrued expense | ||||||||
| Total accrued and other current liabilities | $ | $ | ||||||
6. Alvogen Licensing Agreement
In June 2023, the Company entered into a License Agreement with Alvogen as disclosed in previous filings. On June 21, 2024, the Company received a notice of termination from Alvogen effective immediately. Following the termination of the License Agreement by Alvogen, the amounts advanced pursuant to the amendment became due and payable to Alvogen. Accordingly, the refund liability has not been reclassified to deferred revenue or recorded as revenue as of June 30, 2025 and will remain permanent as refund liability until settled.
Upon termination of the License Agreement, the intellectual property rights licensed to Alvogen under the License Agreement reverted to the Company, and all other rights and obligations of each of the parties immediately ceased, except for outstanding amounts owed as of the time of such expiration or termination. As of June 30, 2025, the refund liability due to Alvogen was $
7. Debt
Streeterville Convertible Note
On November 4, 2022, the Company issued the Streeterville Note, for an aggregate principal amount of $
The Company evaluated the terms of the Settlement Amendment 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 June 30, 2025 and December 31, 2024, the Note carried a remaining principle balance of $
Anson Convertible Promissory Notes
On August 12, 2024, the Company entered into the Purchase Agreement with the Investors. The Company agreed to sell, in
In connection with the above offering, the Company engaged EF Hutton LLC as placement agent (the “Placement Agent”), Pursuant to the terms of the engagement with the Placement Agent, the Company paid a cash fee of
2024 Senior Secured Convertible Promissory Notes
On August 14, 2024, the Company entered into the first tranche Senior Secured Convertible Note Agreements (the “First Tranche Notes”) with Anson Investment Master Fund LP and Anson East Master Fund LP (collectively “Anson”) at various amounts for an aggregate of $
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 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 Shareholder 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 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 Placement Agent. Pursuant to the terms of the engagement with the Placement Agent, the Company paid a cash fee of
Pursuant to the 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 Purchase Agreement and the Notes. In the CWA, each of the Investors provided its consent under certain restrictive provisions, and waived certain rights, including, among other things, a right to participate in certain Qualified Financings (as defined in the CWA) made by us under the Purchase Agreement and the Notes, the prohibition on issuance of certain equity securities, and waiver of any potential liquidated damages arising under that certain Registration Rights Agreement by and between the Company and the Investors dated August 14, 2024, until March 31, 2025. On March 20, 2025, following the conversion of less than $
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 9), 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 $
During the three months ended March 31, 2025, Anson converted $
8. Commitments and Contingencies
Sarah Herzog Memorial Hospital License Agreement
The Company is required to make certain payments related to the development of NRX-101 (the "Licensed Product") in order to maintain the license agreement with the Sarah Herzog Memorial Hospital Ezrat Nashim (“SHMH”) (the "SHMH License Agreement"), including:
Milestone Payments
| End of Phase I Clinical Trials of Licensed Product (completed) | $ | |||
| 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 to in-license US Patent 8,653,120 that claims the use of D-cycloserine for the treatment of chronic pain in exchange for a commitment to pay milestones and royalties as development milestones are reached in the field of chronic pain. The patent is supported by extensive nonclinical data and early clinical data that suggest the potential for NMDA antagonist drugs, such as NRX-101 to decrease both chronic pain and neuropathic pain while potentially decreasing craving for opioids. For the three and six months ended June 30, 2025 and 2024, the Company has recorded
Kadima and Dura Purchase Agreements
On March 29, 2025, the Company entered into certain Membership Interest Purchase and Contribution Agreement (the “Dura Purchase Agreement”), by and among the Subsidiaries, Dura Medical, LLC, and Stephen Durand, CRNA, APRN. Under the terms of the Dura Purchase Agreement, the Company agreed to acquire 100% of the membership interests in Dura Medical, LLC. The transaction includes a combination of cash consideration, contingent earn-out payments based on future performance metrics, and post-closing adjustments. The Dura Purchase Agreement also includes customary representations and warranties, indemnification provisions, and restrictive covenants including non-competition and non-solicitation clauses. The closing of the transaction is subject to customary conditions precedent, including regulatory approvals and third-party consents. The Company expects the acquisition to enhance its operational capabilities in the healthcare sector and contribute to long-term strategic growth.
On May 9, 2025, in furtherance of the Company’s previously announced plans for its subsidiary, HOPE Therapeutics, Inc. (“Hope”), to develop a national network of precision psychiatry clinics. Hope and its wholly-owned subsidiary, HTX Management Company, LLC (“HTX”, and collectively with Hope, the “Subsidiaries”), entered into an Asset Purchase and Contribution Agreement (the “Kadima Purchase Agreement”), with Kadima Neuropsychiatry Institute, Medical Corp. (“Kadima Medical”), Kadima Holdings, Inc. (“Kadima Holdings”), and David Feifel, M.D., PH.D (“Feifel”, and collectively with Kadima Medical and Kadima Holdings, “Kadima”).
The Kadima Purchase Agreement contains representations, warranties and covenants of the Company and Kadima that are customary for a transaction of this nature, including among others, covenants by Kadima regarding the validity of certain material contracts entered into between Kadima and third-parties being assigned to the subsidiaries, title to the assets being sold by Kadima, the condition and sufficiency of the assets being purchased, and Kadima’s rights to its intellectual property, tax liabilities, the investment representations of Kadima, and other open matters in discussions regarding resolution with the intent to close the transaction.
The Purchase Agreement also contains customary indemnification provisions whereby Kadima will indemnify the Company for certain losses arising out of inaccuracies in, or breaches of, the representations, warranties and covenants of Kadima, pre-closing taxes of Kadima, and certain other matters, subject to certain caps and thresholds.
The foregoing description of the Kadima Purchase Agreement does not purport to be complete and is qualified in its entirety by the full text of the Kadima Purchase Agreement, a copy of which is filed as Exhibit 10.6 of the Company’s Quarterly Report on Form 10-Q as of March 31, 2025. The Kadima Purchase Agreement was previously attached to provide investors with information regarding its terms. It is not intended to provide any other factual information about the Subsidiaries or Kadima. In particular, the assertions embodied in the representations and warranties contained in the Purchase Agreement are qualified by information in the confidential disclosure schedules (the "Disclosure Schedules") provided by Kadima in connection with the consummation of the transactions contemplated by the Kadima Purchase Agreement. These Disclosure Schedules contain information that modifies, qualifies and creates exceptions to the representations and warranties and certain covenants set forth in the Kadima Purchase Agreement. Moreover, certain representations and warranties in the Kadima Purchase Agreement were used for the purposes of allocating risk between the subsidiaries and Kadima, rather than establishing matters of fact. Accordingly, the representations and warranties in the Kadima Purchase Agreement should not be relied on as characterization of the actual state of facts regarding the Subsidiaries and/or Kadima.
As of the date of this Report, the transactions contemplated by each of the Dura Purchase Agreement and the Kadima Purchase Agreement have not yet been consummated, and, as disclosed below, with respect to Kadima the parties are working to close the transaction on terms contemplated by the Kadima Purchase Agreement or pursue an alternative outcome acceptable to the parties.
Operating Lease
The Company leases office space on a month-to-month basis. The rent expense for the three and six months ended June 30, 2025 and 2024 was less than $
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 (the “Agreement”), with HTX Management Company, LLC, Kadima Neuropsychiatry Institute, Medical Corp., Kadima Holdings, Inc., and David Feifel, M.D., PH.D. (collectively, “Kadima”), pursuant to which the Company agreed to purchase, and Kadima agreed to sell, on the Closing Date, as defined in the Agreement, certain assets of Kadima, subject to the satisfaction of certain closing conditions (the “Acquisition”). As of the date of this Report, the parties have not closed the Acquisition, and, while no assurances can be given, remain in active discussions to either i) close the Acquisition per the terms of the Agreement, or ii) pursue potential alternative outcomes mutually agreeable to all parties.
9. Equity
Preferred Stock
Pursuant to the terms of the Company’s Second Amended and Restated Certificate of Incorporation, the Company has
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 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 “RD Purchase Agreement”) with the Investors for the sale by the Company of
On or around January 27, 2025, the Company and Anson entered into a Consent and Waiver Agreement (CWA) related to the RD Purchase Agreement and the Notes. Under this agreement, the investors agreed to waive certain rights and restrictions, including their right to participate in certain future financings, restrictions on the Company issuing specific equity securities, and any potential liquidated damages under the Registration Rights Agreement dated August 14, 2024. These waivers are effective through and expired as of March 31, 2025.
As consideration for these waivers, the Company agreed to issue additional compensation to the investors if the volume-weighted average price (VWAP) of the Company’s common stock is lower than the original purchase price at the time investors submit their first conversion notice for Notes issued in the Second or Third Closing. This compensation includes additional shares of common stock (the "Consideration Shares") and warrants to purchase an equal number of shares (the "Consideration Warrants"). The exercise price of the warrants is based on a VWAP-Based Adjustment, calculated as the greater of (a) the VWAP on the trading day before the conversion notice, or (b)
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 $
On March 20, 2025, following the conversion of less than $
On May 15, 2025, the Company granted
Common Stock Warrants
Substitute Warrants
In connection with the Merger in 2021, each warrant to purchase shares of Common Stock of NRx that was outstanding and unexercised immediately prior to the effective time (whether vested or unvested) was assumed by Big Rock Partners Acquisition Corp. ("BRPA") and converted into a warrant, based on the exchange ratio (of
Assumed Public Warrants
Prior to the Merger, the Company had
During the three and six months ended June 30, 2025 and 2024
Assumed Private Placement Warrants
Prior to the Merger, the Company had outstanding
The Company recognized a gain on the change in fair value of the Private Placement Warrants for the three and six months ended June 30, 2025 and 2024. Refer to Note 11 for discussion of the fair value measurement of the Company’s warrant liabilities.
Investor Warrants
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’s Warrant to purchase up to
On May 23, 2024, the Company issued Underwriter’s Warrant to purchase up to
Alvogen Warrants
In conjunction with the amended Alvogen licensing agreement discussed in Note 6, on February 7, 2024 the Company issued warrants to purchase up to
Anson Warrants
The Anson Warrants, originally issued in the 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 were initially measured at fair value using a Black-Scholes model and have subsequently been measured based on the listed market price of such warrants. Warrant liabilities are classified as current liabilities on the Company's condensed consolidated balance sheets. On August 14, 2024, in conjunction with the issuance of the First Tranche Notes, the Company issued warrants to purchase up to
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
As discussed above, on January 29, 2025, in conjunction with the issuance of the RD Shares, the Company issued RD Warrants to purchase up to
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 June 30, 2025, the aggregate fair value of all liability classified warrants, which include Anson Warrants, RD Warrants and Private Placement 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 | — | |||||||||||||||
| Expired | ( | ) | — | — | — | |||||||||||
| Outstanding as of June 30, 2025 | $ | $ | ||||||||||||||
10. Stock-Based Compensation
2016 Omnibus Incentive Plan
Prior to the Merger, NRx maintained its 2016 Omnibus Incentive Plan (the “2016 Plan”), under which NeuroRx granted incentive stock options, restricted stock awards, other stock-based awards, or other cash-based awards to employees, directors, and non-employee consultants. The maximum aggregate shares of Common Stock that were subject to awards and issuable under the 2016 Plan was
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 June 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 six 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:
| Number of shares | Weighted average price | Weighted average remaining contractual life (in years) | Aggregate intrinsic value (in thousands) | |||||||||||||
| Outstanding as of December 31, 2023 | $ | $ | ||||||||||||||
| Options granted | — | — | ||||||||||||||
| Forfeited/Expire | ( | ) | — | — | ||||||||||||
| Outstanding as of December 31, 2024 | ||||||||||||||||
| Options granted | ||||||||||||||||
| Forfeited/Expire | ( | ) | — | — | ||||||||||||
| Outstanding as of June 30, 2025 | ||||||||||||||||
| Options vested and exercisable as of June 30, 2025 | $ | $ | ||||||||||||||
Stock-based compensation expense related to stock options was less than $
At June 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:
| Awards | Weighted Average Grant Date Fair Value | |||||||
| Balance as of December 31, 2023 (unvested) | $ | |||||||
| Granted | ||||||||
| Vested | ( | ) | $ | |||||
| Forfeited | ( | ) | $ | |||||
| Balance as of December 31, 2024 (unvested) | ||||||||
| Granted | $ | — | ||||||
| Vested | $ | |||||||
| Forfeited | $ | |||||||
| Balance as of June 30, 2025 (unvested) | ||||||||
On July 12, 2022, the Board granted an award of
On December 28, 2023, the Company granted
Stock-based compensation expense related to RSAs was $
In October 2024, the Company's CEO 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 June 30, | Six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (Unaudited) | ||||||||||||||||
| Stock-based compensation expense | ||||||||||||||||
| General and administrative | $ | $ | $ | $ | ||||||||||||
| Research and development | ||||||||||||||||
| Total stock-based compensation expense | $ | $ | $ | $ | ||||||||||||
11. Fair Value Measurements
Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the three and six months ended June 30, 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 June 30, 2025 and December 31, 2024, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value (in thousands):
| Description | Level | June 30, 2025 | December 31, 2024 | |||||||||
| (Unaudited) | ||||||||||||
| Assets: | ||||||||||||
| Money Market Account | 1 | $ | $ | |||||||||
| Liabilities: | ||||||||||||
| Warrant liabilities (Note 9) | 3 | $ | $ | |||||||||
| Convertible note payable and accrued interest (Note 7) | 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:
| June 30, | ||||||
| 2025 | ||||||
| Stock price on valuation date | ||||||
| Time to expiration | – | |||||
| Cost of debt | ||||||
| Equity volatility | – | |||||
| Risk-free rate | ||||||
| Probability of credit default prior to maturity | ||||||
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 | $ | |||
| Convertible note payable - current portion as of June 30, 2025 | $ | |||
| Convertible note payable, net of current portion as of June 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 no transfers between levels within the fair value hierarchy during the periods presented. Inherent in a Black Scholes options pricing model are assumptions related to expected share-price volatility, expected life, risk-free interest rate and dividend yield. The Company estimates the volatility of its Common Stock based on historical volatility that matches the expected remaining life of the warrants. The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected remaining life of the warrants. The expected life of the warrants is assumed to be equivalent to their remaining contractual term. The dividend rate is based on the historical rate, which the Company anticipates remaining at zero.
The 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:
| June 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 | $ |
| 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 | $ |
12. Segment Reporting
The Company operates as a operating and reportable segment, consistent with the manner in which the Chief Executive Officer, designated as the Chief Operating Decision Maker (“CODM”) of the Company, evaluates the Company’s performance and allocates resources. The Company’s operations solely consist of the development of novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, and post-traumatic stress disorder (“PTSD”) and now schizophrenia.
The Company did generate any revenue during the six months ended June 30, 2025 or the year ended December 31, 2024. The CODM evaluates performance based on operating expenses and monitors key expense categories related to the Company’s research and development activities, as well as general and administrative functions. 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 United States of America.
Significant Segment Information
All of the Company’s assets relate to this single operating segment, see the accompanying balance sheets.
All of the Company’s operating expenses, which consists of research and development and general and administrative expenses, relate to this single operating segment, see the accompanying statements of operations.
The following table reconciles the loss from operations to total loss:
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| Expense Category | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Loss from operations | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Interest income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest expense | ||||||||||||||||
| Change in fair value of convertible notes payable | ||||||||||||||||
| Change in fair value of warrant liabilities | ( | ) | ( | ) | ||||||||||||
| Loss on issuance of the Registered Direct Offering | ||||||||||||||||
| convertible note default penalties | ||||||||||||||||
| Loss on Considerations Shares and Warrants | ||||||||||||||||
| Loss on convertible note conversions | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
Long-lived assets consist of property, plant, and equipment, net which are included in other assets in the balance sheet as they are not material. Long-lived assets by year are as follows:
| June 30, 2025 | December 31, 2024 | |||||||
| Computers, cost | $ | $ | ||||||
| Accumulated depreciation | ( | ) | ( | ) | ||||
| Total equipment | $ | $ | ||||||
13. 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.
14. Related Party Transactions
Glytech Agreement
The Company licenses patents that are owned by Glytech, LLC (“Glytech”), pursuant to a license agreement (the “Glytech Agreement”). Glytech is owned by Daniel Javitt, a co-founder and former director of the Company. The Glytech Agreement requires that the Company pay Glytech for ongoing scientific support and also reimburse Glytech for expenses of obtaining and maintaining patents that are licensed to the Company. During the three months ended June 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, that contain a combination of pharmaceutical components different from those contained in NRX-100 and NRX-101. On November 6, 2022 the Glytech Agreement was amended whereby Glytech agreed to transfer and assign the remainder of the Licensed Technology and the Excluded Technology to the Company for no additional consideration at any time upon receipt of written notice from the Company if, on or prior to 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 shareholder in the Company and a member of the Board of Directors. Therefore, his services are deemed to be a related party transaction. He served the Company on a full-time basis as CEO under an employment agreement with the Company until March 8, 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 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 $
The Javitt Amendment also provides, subject to the approval of the Board of Directors, for a grant of
The term “New Drug Application Date” means the date upon which the FDA files the Company’s new drug application for the Antidepressant Drug Regimen (as defined below) for review. The term “New Drug Approval Date” means date upon which the FDA has both approved the Company’s Antidepressant Drug Regimen and listed the Company’s Antidepressant Drug Regimen in the FDA’s “Orange Book”. The term “Antidepressant Drug Regimen” means NRX-101, a proprietary fixed-dose combination capsule of d-cycloserine and Lurasidone, administered for sequential weeks of daily oral treatment following patient stabilization using a single infusion of NRX-100 (ketamine) or another standard of care therapy.
Consulting Agreement with Zachary Javitt
Zachary Javitt is the son of Dr. Jonathan Javitt. Zachary Javitt provides services related to website, IT, and marketing support under the supervision of the Company’s CEO who is responsible for assuring that the services are provided on financial terms that are at market. The Company paid this family member a total of less than $
Included in accounts payable were $
15. Subsequent Events
From July 9, 2025 through August 14, 2025, the Company sold an aggregate of
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, and post-traumatic stress disorder (“PTSD”) and schizophrenia. All of our current drug development activities are focused drugs that modulate on the N-methyl-D-aspartate (“NMDA”) receptor in the brain and nervous system, a neurochemical pathway that has been disclosed in detail in our annual filings. The Company has two lead drug candidates – NRX-100, a preservative-free formulation of ketamine for intravenous infusion, and NRX-101, an oral fixed dose combination of D-cycloserine and lurasidone. NRX-100 and NRX-101 are in the process of submission for Food and Drug Administration (“FDA”) approval as follows:
| 1. |
An Abbreviated New Drug Application (“ANDA”) for NRX-100 was filed, with Priority Review requested, during the second quarter of 2025 with a first response received August 13, 2025. |
| 2. |
A New Drug Application (“NDA”) for NRX-100, originally initiated during the fourth quarter of 2024, is expected to be completed in September 2025. This follows the Company’s successful application for a waiver under the Prescription Drug User Fee Act ("PDUFA"), which is expected to save the Company approximately $4.3 million in filing fees and grant of Fast Track Designation for NRX-100 for “Treatment of Suicidal Ideation in Patients with Depression, including Bipolar Depression. The Company has applied to receive a Commissioner’s National Priority Voucher (CNPV), which could significantly reduce review time. |
| 3. |
An NDA filing for NRX-101 has been initiated with the transmission of the Module 3 manufacturing file to publishing. The drug was previously awarded Breakthrough Therapy Designation and accordingly the Company is requesting rolling review of the NDA. Breakthrough Therapy Designation is granted by the FDA to facilitate the development, and expedite the review of drugs to treat serious conditions meet an unmet medical need, and have demonstrated preliminary evidence of efficacy as determined by the FDA. The Company anticipates decision dates from the FDA for both its NDA applications potentially as early as year-end 2025 (NRX-100) and the first quarter of 2026 (NRX-101). |
In February 2024, NRx incorporated HOPE Therapeutics, Inc. (“HOPE”), a medical care delivery organization focused on providing cutting-edge, comprehensive interventional psychiatric treatment of the above conditions with the most effective treatments available, including NMDA-targeted and other neuroplastic drugs, such as ketamine, Spravato and NRX-101, neuromodulatory devices, such as Transcranial Magnetic Stimulation (“TMS”), digital therapeutics, and medication management.
NeuroRx is organized as a traditional research and development (“R&D”) company, whereas HOPE is organized as a medical care delivery company intended to own and/or operate clinics that serve patients with suicidal depression, PTSD, and other serious Central Nervous System (“CNS”) disorders. Management’s plan, through the establishment of HOPE, is to transform NRx from a pre-revenue biotechnology company to a revenue-generating enterprise that continues to develop life-saving drugs and technologies through NeuroRx, while also treating patients through HOPE.
During the second quarter of 2025 and in the subsequent period, key achievements by the Company in support of its overall mission to improve and save the lives of patients affected by central nervous system disorders including suicidal depression, chronic pain, post-traumatic stress disorder and schizophrenia include the following:
Drug Development
| ● |
Grant of Fast Track Designation for NRX-100 from the FDA for all indications and types of depression and related disorders based on its potential to satisfy an unmet medical need. This designation represents an approximately 10-fold expansion of the addressable market to 13 million Americans, compared to the original Fast Track Designation issued in 2017 for bipolar depression alone. The Designation letter contains a specific finding that NRX-100 addresses an “unmet medical need.” This is a specific qualifying requirement for the Commissioner’s National Priority Voucher Program. |
|
| ● |
Filing of an ANDA for NRX-100 (preservative-free intravenous ketamine). |
|
| ● |
Filing of Commissioner’s National Priority Voucher application for intravenous ketamine (NRX-100). |
|
| ● |
Submission of stability data for NRX-100 to the manufacturing data on file with FDA sufficient to support three years of room temperature shelf stability for NRX-100. |
|
| ● |
Submission of draft labeling for NRX-100 in the treatment of suicidal depression based on the Fast Track Designation received. |
|
| ● |
Completion of a toxicology assessment of Benzethonium Chloride, documenting its lack of “Generally Recognized as Safe” (GRAS) status and lack of safety data to support its use in intravenous presentations of ketamine. |
|
| ● |
Filing of a Citizen’s Petition with the U.S. Food and Drug Administration to seek the removal of benzethonium chloride, a toxic preservative, from all ketamine products for intravenous administration. |
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| ● |
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. |
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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. |
Interventional Psychiatry Clinics (HOPE Therapeutics)
| ● |
Execution of definitive Purchase Agreement and receipt of final regulatory clearance from Florida’s Agency for Health Care Administration (“ACHA”) to proceed with closing the acquisition of Dura Medical. |
|
| ● |
Execution of binding letter of intent to acquire the assets of NeuroSpa TMS of Tampa, FL. |
|
| ● |
Execution of a binding letter of intent to acquire a 49% interest in Cohen and Associates, LLC. |
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| ● |
Receipt of approval pending legal stipulations for $7.8 million of debt financing to support the acquisition of Dura Medical, NeuroSpa TMS, and Cohen Psychiatry. |
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| ● |
Execution of a definitive purchase agreement, subject to standard closing conditions and agreement between the parties regarding the resolution of ongoing discussions, to purchase the non-clinical assets of Kadima Neuropsychiatry Institute. | |
| ● |
Execution of a non-binding term sheet for a strategic investment from a global medical device manufacturer into HOPE. |
Development of NRX-101 for Suicidal Treatment-Resistant Suicidal Bipolar Depression
On May 5, 2024, the Company announced final data from the recently completed phase 2b/3 trial of NRX-101 in suicidal bipolar depression, with a significantly improved safety profile as demonstrated by a statistically significant reduction in akathisia, an adverse event considered by many experts to be a precursor to suicide. Given the vital need for safer medications in this at-risk population, we plan to submit an NDA to the US FDA for treatment of bipolar depression patients at risk of akathisia, based on these data as well as additional data from our STABIL-B trial.
Trial participants had identical mean scores on the BARS at baseline with subsequent decrease in the NRX-101 treated group versus an increase in the lurasidone-treated group, yielding a 76% relative mean difference between the groups. The difference was apparent at the first post-randomization visit and continued throughout the trial. (Fig 1) Over the 42 days of observation, an effect size of .37 was identified with a statistically significant P value of 0.025 on the Mixed Model for Repeated Measures methodology agreed to with FDA in the 2018 Special Protocol Agreement. Akathisia as ascertained by a 1 point increase in the BARS was seen in 11% of participants randomized to lurasidone (comparable to previous reports in the literature) and seen in only 2% of those treated with NRX-101, an akathisia level that was previously reported for the placebo arm of the lurasidone registration trial.
Akathisia was a prespecified key safety endpoint of the Company’s clinical trial. Hence this finding is not a “post-hoc” observation. As previously noted, this clinical trial of 91 participants with suicidal bipolar depression who were not pre-treated with ketamine demonstrated that NRX-101 and lurasidone were comparable in their antidepressant effect. A 33% but statistically non-significant sustained decrease in suicidality was also seen favoring NRX-101. As noted above, improved antidepressant efficacy is not required to seek drug accelerated drug approval based on a statistically-significant safety benefit.
The results released on May 24 are consistent with and amplify the results of the Company’s previously published STABIL-B trial (Fig 2 below). In both trials a meaningful reduction in Akathisia was seen, which was statistically significant in the current trial (P<.025) and near significant (P=0.11) in the STABIL-B with similar effect sizes The STABIL-B additionally demonstrated a statistically-significant reduction in suicidality on the Columbia Suicide Severity Rating Scale (C-SSRS).
1 Nierenberg A, Lavin P, Javitt DC, et. al. NRX-101 vs lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior; a randomized prospective phase 2 trial. Int J Bipolar Dis 2023;11:28-38, doi.org/10.1186/s40345-023-00308-5.
Reduced suicidality associated with the administration of D-cycloserine has additionally been demonstrated by Chen and Coworkers.
Figure 2: Results from published STABIL-B Trial
Incorporation of HOPE Therapeutics and progress towards an NDA for HTX-100 (IV ketamine) in the treatment of suicidal depression
In the first quarter of fiscal 2024, the Company incorporated HOPE Therapeutics as a wholly-owned subsidiary and engaged its auditors who in August 2024 completed an audit of its financial statements which will be necessary for the intended spin-off of HOPE to the Company’s shareholders. Intravenous ketamine has now become a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product. Intranasal Esketamine is approved by the FDA (SPRAVATO®), but has not demonstrated a benefit on suicidality and is not approved for use in patients with bipolar depression. Attempts to use intranasal racemic ketamine for suicidal depression have failed.
The Company has formed data-sharing partnerships to license clinical trial data from a French Government-funded trial and two National Institute of Health (NIH)-funded trials all of which demonstrate efficacy of racemic Intravenous ketamine against depression and two of which demonstrate statistically significant benefit vs suicidality. The Company’s role is to reformat these data into the required presentation required for review by the FDA.
In contrast to nasal ketamine, Intravenous racemic ketamine demonstrates dramatic and immediate reduction of suicidality in patients with both Major Depressive Disorder and Bipolar Depression. Grunebaum and colleagues demonstrated a rapid and statistically significant reduction in Suicidal Ideation at day 1 (p=0.0003) and in depression (P=0.0234), as measured by the Profile of Mood States among patients randomized to IV Ketamine compared to those randomized to midazolam. This trial was published in the American Journal of Psychiatry . Abbar and colleagues similarly published 84% remission from suicidality on the C-SSRS in patients treated with ketamine, vs. 28% in those treated with placebo (P<.0001). This trial was published in the British Medical Journal.
In November 2023, the Company initiated manufacture of ketamine together with Nephron Pharmaceuticals, Inc. to develop a single patient presentation of ketamine. Stability and sterility data deemed sufficient to establish three year room temperature shelf life were obtained. Demonstrating the ability to manufacture drug product, and prove its stability, are critical components of the drug approval process with the US FDA.
A long-term challenge with ketamine is that the current formulation (KETALAR®) is highly acidic. While it is suitable for intravenous use, it cannot be administered subcutaneously. In March 2024 the Company demonstrated the formulation of a pH neutral patentable form of IV ketamine that it anticipates will have widespread applicability both in treatment of depression and chronic pain.
Treatment of Urinary Tract Infection (“UTI”) and Urosepsis:
Although treatment of UTI is quite different from use of NRX-101 to treat Central Nervous System disorders, D-cycloserine was originally developed as an antibiotic because of its role in disrupting the cell wall of certain pathogens. During Q3 2023, NRx tested NRX-101 and its components against resistant pathogens that appear on the Congressionally mandated QIDP list and proved in vitro effectiveness against antibiotic-resistant E. coli, Pseudomonas, and Acinetobacter. Accordingly, NRx was granted QIDP designation, Fast Track Designation, and Priority Review by the US FDA in January 2024.
In recent years, increased antibiotic resistance to common pathogens that cause urinary tract infections and urosepsis (i.e., sepsis originating in the urinary tract) has resulted in a marked increase in cUTI, hospitalization, and death from urosepsis. The US Center for Disease Control and Prevention reports that more than 1.7 million Americans contract sepsis each year, of whom at least 350,000 die during their hospitalization or are discharged to hospice (CDC Sepsis Ref.). There are approximately three million patients per year who contract cUTI in the U.S. annually (Lodise, et. al.). Additionally, should NRX-101 succeed in clinical trials, the Company will consider developing a follow-on product that is anticipated to achieve another 20 years of patent exclusivity.
A key challenge in the treatment of cUTI is the tendency of advanced antibiotics to cause C. Difficile infection, which is fatal in 10% of those who contract it over the age of 65 and results in prolonged hospitalization in many more. The Company recently announced data demonstrating that NRX-101 does not compromise the intestinal microbiome, unlike common antibiotics including Clindamycin and Ciprofloxacin. Should these findings be documented in human patients, NRX-101 would represent the only treatment for cUTI that does not cause C. Difficile infection.
Activities surrounding this development program, as well as chronic pain, are on hold into 2026 as the Company focuses on its nearer term, more significant development programs.
Recent Developments
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 June 30, 2025 the Company sold an aggregate of 399,078 of its common stock shares for approximately $1.0 million, net of less than $0.02 million in offering costs.
We executed a term sheet with a publicly-traded strategic investor to provide additional capital to support the expansion of HOPE clinics. In addition, management is negotiating with several commercial lenders to provide additional financing to support the acquisition of additional clinics on standard commercial loan terms. Although no assurances can be given, and assuming we’re able to consummate the proposed financings, management believes that we will have sufficient financing to consummate our previously announced acquisitions, execute our business plan and achieve our 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 Citizens Petition (Sapko, M. T., Panicucci, R., & Javitt, J. (2025). Toxicological Evaluation of Benzethonium Chloride in Ketamine Formulations. Zenodo. https://doi.org/10.5281/zenodo.16883346) with FDA noting that the Benzethonium Chloride (BZT) preservative in ketamine is not Generally Recognized as Safe (GRAS) and has not been demonstrated to be safe in the context of this product. Historically, BZT was added to ketamine to enable multidose use and multi-patient use from a single vial. Those uses are no longer common in US healthcare facilities. We have performed an extensive review of the toxicology literature around BZT and determined that FDA no longer allows BZT to be used in hand cleansers and topical antiseptics. BZT is part of a class of quaternary amines that have been shown to be toxic to corneal and conjunctival cells. A related compound in this class, Benzalkonium Chloride, has been removed from many eyedrops because of this demonstrated toxicity. The toxicology review link suggests that while single dose administration of preserved ketamine is generally thought of as safe, the cumulative dose of BZT with repeated intravenous administration may approach a toxicologically-concerning exposure to this compound.
In general, we anticipate that a preservative-free form of ketamine will be welcomed by physicians and patients, which may enable NRX-100 to gain a larger share of the existing ketamine market than would be available to an undifferentiated product. However, should the Citizens Petition be granted the share of the generic market captured by NRX-100 could be considerably higher.
Our path to New Drug Approval of Ketamine for treatment of depression was substantially augmented on August 8, 2025 by award of an expanded Fast Track Designation (FTD) to NRX-100 by the FDA Division of Psychiatry Products. In 2017, FDA awarded FTD to NRX-100 in association with NRX-101 for the treatment of suicidal bipolar depression. FDA subsequently requested in 2018 that the Company establish a separate Investigative New Drug file for NRX-100 and the Company complied. Last week, FDA gave a far broader Fast Track Designation to NRX-100, designating it for “Treatment of suicidal ideation in depression, including bipolar depression,” According to the US Centers for Disease Control (CDC), 13 million Americans develop suicidal ideation each year, with 1.5 million attempting suicide and an American dying of suicide every 11 minutes.
FDA further augmented the potential path to market of NRX-100 by establishing the Commissioner’s National Priority Voucher Program (CNPV). The key criteria are shown below, taken from the FDA website. To receive a CNPV, a product must meet at least one of the criteria below. Management believes that NRX-100 meets all five criteria.
| ● |
Addressing a U.S. public health crisis. An example could include developing a universal flu vaccine that could provide broad protection against multiple strains of influenza, including those with pandemic potential. |
| ● |
Delivering more innovative cures for the American people. The focus for this priority is transformative impact that far outstrips the threshold for breakthrough therapy designation. Examples could include creating a novel immunotherapy that reprograms the body’s immune system to fight multiple diseases; or transforming mental health care through a novel treatment for PTSD. |
| ● |
Addressing a large unmet medical need. This includes a condition that available therapies do not adequately diagnose or treat, including drugs to treat or prevent rare diseases or addressing America’s chronic disease crisis. |
| ● |
Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency. Examples could include companies with new manufacturing establishments that shift manufacturing of essential medicines (such as generic sterile injectables) from foreign facilities to the U.S.; or a clinical trial that maintains robust U.S. enrollment to support generalizability for Americans against the U.S. standard of care. |
| ● |
Increasing affordability. This could include a company that lowers the U.S. price of a drug or drugs consistent with Most Favored Nation pricing or reduces other downstream medical utilization to lower overall healthcare costs. |
Receipt of a CNPV affords a substantially faster review time of 1-2 months vs. 10-12 months, enhanced communication throughout the review process, a multidisciplinary team-based evaluation, and potential for accelerated approval if the applicable requirements are met. Key to this process is determination that the candidate product meets a large, unmet medical need. That determination was specifically made in the case of NRX-100 by the Division of Psychiatry Products and included in the Fast Track Determination letter. There is an additional feature to the CNPV that may limit eligibility to a relatively few drugs. The CNPV requires that a Company’s module 3 manufacturing data be on file. These data were initially filed for NRX-100 in December 2024 and the stability data were updated in July 2025 to support three years of room temperature shelf stability.
NRx intends to seek Accelerated Approval of NRX-100. The data that have been licensed from the Government of France and Columbia University demonstrate that intravenous ketamine is superior to placebo and to active placebo in reducing suicidal ideation and depression within hours and has an effect duration of about a week. The PCORI-funded trial of ketamine vs. ECT demonstrates non-inferiority to ECT on depression over a 6 month period. The Company believes that these data are sufficient for an FDA grant of initial market access subject to confirmatory data. However, longer term data are desirable for a drug that may ultimately be used in millions of patients each year. Additional detail regarding established ketamine efficacy data is noted below.
In addition to the experimental data shown above, the Company will be presenting Real World Data from two sources that capture medical record information from approximately 60,000 and 120,000 patients, respectively. An example drawn from the first 20,000 such patients examined is depicted below and suggests that the effect of ketamine seen in Real World Data are consistent with the smaller, but better controlled results observed in randomized clinical trials.
Under the accelerated approval pathway, a Company is obligated to provide confirmatory data of safety and efficacy within five years of accelerated approval. In this case, NRx has contracted with the sponsors of a 450-person randomized non-inferiority trial of intravenous racemic ketamine compared to intranasal S-ketamine. The Company hypothesizes that NRX-100 will prove to be non-inferior to intranasal S-ketamine in reducing symptoms of depression and may prove superior in reducing symptoms of suicidality.
NRX-100 Path to Market
Both the ANDA and NDA pathways rely on the completion of the Module 3 manufacturing file. The Abbreviated New Drug Application (ANDA) for NRX-100 was received by FDA on June 13, 2025. On August 13, 2025, NRx Pharmaceuticals received a letter from the FDA in response to the Company’s Abbreviated New Drug Approval (ANDA) application for NRX-100 as enumerated in the Form 8-K filed August 15, 2025. The Company will respond to the comments and resubmit the ANDA in cooperation with FDA. Management believes that the guidance received by the FDA is a routine part of the regulatory process, provides a clear path to market for preservative-free ketamine, and will not result in any undue delay.
NRX-101
Clinical progress related to NRX-101 is documented in recently-filed forms 10-K and 10-Q. During Q2 2025 and in subsequent events, management has focused on preparing the New Drug Application of NRX-101, submitting more than 80,000 pages of manufacturing, non-clinical, and clinical material in July 2025. Breakthrough Therapy Designation was awarded to NRX-101 by the FDA in 2018.
As noted previously, NRX-101 demonstrated a statistically-significant benefit in reduction of suicidality and reduction of akathisia in a randomized, well-controlled trial against lurasidone. These findings confirm the initial results reported in the Company’s STABIL-B trial. The Company anticipates filing an NDA for Accelerated Approval of NRX-101 for treatment of “Suicidal Bipolar Depression in patients with Akathisia and Active Suicidal Ideation despite standard of care therapy.” NRX-101 is the only oral medicine that has ever been demonstrated in two randomized trials to reduce active suicidality and akathisia, to the Company’s knowledge. The Company is in active discussion with an academic medical center that has already demonstrated leadership in the successful phase 2 trial to conduct the confirmatory research required post Accelerated Approval under an already-funded national multicenter trial. The Company is currently applying for a PDUFA fee waiver from FDA on the grounds of overwhelming public health need.
Recent evidence suggests that NRX-101 may confer a significant added advantage to the clinical results of Transcranial Magnetic Stimulation (Cole J, et.al. Efficacy of Adjunctive D-Cycloserine to Intermittent Theta-Burst Stimulation for Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022;79(12):1153–1161. doi:10.1001/jamapsychiatry.2022.3255). The Company is initiating an expanded-access protocol to make NRX-101 available for this application and is organizing a phase 2b/3 randomized clinical trial to confirm this finding.
Financial Results
Since inception, the Company has incurred significant operating losses. For the three months ended June 30, 2025 and 2024, the Company’s net loss was $17,581 million and $7.9 million, respectively. For the six months ended June 30, 2025 and 2024, the Company’s net loss was $23.1 million and $14.4 million, respectively. As of June 30, 2025, the Company had an accumulated deficit of $301.4 million, a stockholders’ deficit of $35.6 million and a working capital deficit of $35.9 million.
Going Concern
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 in 2025 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 shareholders. The Company cannot make any assurances that additional financing will be available to it and, if available, on acceptable terms, or that it will be able to refinance its existing debt obligations which could negatively impact the Company’s business and operations and could also lead to a reduction in the Company’s operations. We will continue to carefully monitor the impact of our continuing operations on our 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
Operating Expense
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 expense consists primarily of salaries, stock-based compensation, consultant fees, and professional fees for legal and accounting services.
Settlement expense
Settlement expense during the six months ended June 30, 2025 consists of deductibles related to insurance claims.
Results of operations for the three months ended June 30, 2025 and 2024
The following table sets forth the Company’s selected statements of operations data for the following periods (in thousands):
| Three months ended June 30, |
Change |
|||||||||||
| 2025 |
2024 |
Dollars |
||||||||||
| (Unaudited) |
||||||||||||
| Operating expense: |
||||||||||||
| Research and development |
$ | 987 | $ | 2,804 | $ | (1,817 | ) | |||||
| General and administrative |
2,743 | 4,246 | (1,503 | ) | ||||||||
| Total operating expense |
3,730 | 7,050 | (3,320 | ) | ||||||||
| Loss from operations |
$ | (3,730 | ) | $ | (7,050 | ) | $ | 3,320 | ||||
| Other expense (income): |
||||||||||||
| Interest income |
$ | (2 | ) | $ | (7 | ) | $ | 5 | ||||
| Convertible note default penalty |
— | 849 | (849 | ) | ||||||||
| Change in fair value of convertible note payable |
5,565 | 23 | 5,542 | |||||||||
| Change in fair value of warrant liabilities |
6,414 | (18 | ) | 6,432 | ||||||||
| Loss on convertible note conversion |
1,874 | — | 1,874 | |||||||||
| Total other expense |
13,851 | 847 | 13,004 | |||||||||
| Loss before tax |
(17,581 | ) | (7,897 | ) | (9,684 | ) | ||||||
| Net loss |
$ | (17,581 | ) | $ | (7,897 | ) | $ | (9,684 | ) | |||
Operating expense
Research and development expense
For the three months ended June 30, 2025, the Company recorded $1.0 million of research and development expense, as compared to approximately $2.8 million for the three months ended June 30, 2024. The decrease of $1.8 million is related primarily due to the conclusion of the phase 2 study related to NRX-101 and the Company's cash conservation efforts, specifically to reduction in $0.4 million in clinical costs, $1.5 million in other regulatory and process development costs, and less than $0.1 million in payroll and payroll related expenses. The research and development expense for each of the three months ended June 30, 2025 and 2024, includes less than $0.1 million of non-cash stock-based compensation.
General and administrative expense
For the three months ended June 30, 2025, the Company recorded $2.7 million of general and administrative expense, as compared to approximately $4.2 million for the three months ended June 30, 2024. The decrease of $1.5 million is related primarily to a decrease of $1.2 million in consultant and legal fees, $0.1 million in insurance expense and $0.2 million in employee expenses and other general and admin expenses. General and administrative expense includes less than $0.1 million of non-cash stock-based compensation for both of the three months ended June 30, 2025 and 2024.
Other expense (income)
Interest income
For the three months ended June 30, 2025, the Company recorded less than $0.1 million of interest income, as compared to less than $0.1 million of interest income for the three months ended June 30, 2024.
Convertible note default penalty
For the three months ended June 30, 2025, the Company recorded $0 million of a default penalty, as compared to $0.8 million of a default penalty for the three months ended June 30, 2024. The decrease is due to alleged default in connection with the convertible note during the three months ended June 30, 2024.
Change in fair value of convertible notes payable
For three months ended June 30, 2025, the Company recorded a loss of $5.6 million related to the change in fair value of the convertible notes payable which are accounted for under the fair value option. For the three months ended June 30, 2024, the Company recorded a loss of less than $0.1 million related to the change in fair value of the convertible note payable which is accounted for under the fair value option.
Change in fair value of warrant liabilities
For the three months ended June 30, 2025, the Company recorded a loss of $6.4 million related to the change in fair value of the warrant liabilities, as compared to a gain of less than $0.1 million for the three months ended June 30, 2024. The increase in loss during the three months ended June 30, 2025 was attributed to the warrants issued in conjunction with the First, Second and Third Tranches of the Anson Notes as well as increase in the Company’s stock prices.
Loss on convertible note conversion
For the three months ended June 30, 2025, the Company recorded a loss of $1.9 million related to convertible note conversion, as compared to $0 during the three months ended June 30, 2024. These conversions were calculated as the difference between the conversion price per the terms of the Anson agreement (See Note 7) relative to the fair value of the common stock on the date of conversion.
Results of operations for the six months ended June 30, 2025 and 2024
The following table sets forth the Company’s selected statements of operations data for the following periods (in thousands):
| Six months ended June 30, |
Change |
|||||||||||
| 2025 |
2024 |
Dollars |
||||||||||
| (Unaudited) |
||||||||||||
| Operating expense: |
||||||||||||
| Research and development |
$ | 1,791 | $ | 4,552 | $ | (2,761 | ) | |||||
| General and administrative |
5,686 | 8,496 | (2,810 | ) | ||||||||
| Settlement Expense |
100 | — | 100 | |||||||||
| Total operating expense |
7,577 | 13,048 | (5,471 | ) | ||||||||
| Loss from operations |
$ | (7,577 | ) | $ | (13,048 | ) | $ | 5,471 | ||||
| Other expense(income): |
||||||||||||
| Interest income |
$ | (6 | ) | $ | (34 | ) | $ | 28 | ||||
| Interest expense |
— | 230 | (230 | ) | ||||||||
| Convertible note default penalty |
— | 849 | (849 | ) | ||||||||
| Change in fair value of convertible note payable |
6,530 | 341 | 6,189 | |||||||||
| Change in fair value of warrant liabilities |
3,518 | (9 | ) | 3,527 | ||||||||
| Loss on issuance of the Registered Direct Offering |
729 | — | 729 | |||||||||
| Loss on Considerations Shares and Warrants |
1,277 | — | 1,277 | |||||||||
| Loss on convertible note conversion |
3,467 | — | 3,467 | |||||||||
| Total other (income) expense |
15,515 | 1,377 | 14,139 | |||||||||
| Loss before tax |
(23,092 | ) | (14,425 | ) | (8,667 | ) | ||||||
| Net loss |
$ | (23,092 | ) | $ | (14,425 | ) | $ | (8,667 | ) | |||
Operating expense
Research and development expense
For the six months ended June 30, 2025, the Company recorded $1.8 million of research and development expense, as compared to approximately $4.6 million for the six months ended June 30, 2024. The decrease of $2.8 million is related primarily due to the conclusion of the phase 2 study related to NRX-101 and the Company's cash conservation efforts, $0.8 million in clinical costs, $1.5 million in other regulatory and process development costs, and $0.5 million in regulatory and process consultants fees. The research and development expense for each of the six months ended June 30, 2025 and 2024, respectively, includes less than $0.1 million of non-cash stock-based compensation.
General and administrative expense
For the six months ended June 30, 2025, the Company recorded $5.7 million of general and administrative expense, as compared to approximately $8.5 million for the six months ended June 30, 2024. The decrease of $2.8 million is related primarily to a decrease of $2.1 million in consultant fees, $0.2 million in insurance expense, and $0.6 million in employee expenses and other general and admin expenses, partially offset by an increase of $0.1 million in legal expense. General and administrative expense includes $0.2 million and $0.3 million of non-cash stock-based compensation for the six months ended June 30, 2025 and 2024, respectively.
Settlement expense
Settlement expense during the six months ended June 30, 2025 consists of $0.1 million of deductibles related to insurance claims, as compared to $0 during the six months ended June 30, 2024.
Other expense (income)
Interest income
For the six months ended June 30, 2025, the Company recorded less than $0.1 million of interest income, as compared to less than $0.1 million of interest income for the six months ended June 30, 2024.
Interest expense
For the six months ended June 30, 2025, the Company recorded $0 of interest expense, as compared to $0.2 million of interest expense for the six months ended June 30, 2024. The decrease of $0.2 million is due to premiums for cash payments on the convertible note for the six months ended June 30, 2024.
Convertible note default penalty
For the six months ended June 30, 2025, the Company recorded $0 million of a default penalty, as compared $0.8 million of a default penalty for the six months ended June 30, 2024. The decrease is due to alleged default in connection with the convertible note in 2024 and no such event of default during the six months ended June 30, 2025.
Change in fair value of convertible notes payable
For six months ended June 30, 2025, the Company recorded a loss of $6.5 million related to the change in fair value of the convertible notes payable which are accounted for under the fair value option. For the six months ended June 30, 2024, the Company recorded loss of $0.3 million related to the change in fair value of the convertible note payable which is accounted for under the fair value option.
Change in fair value of warrant liabilities
For the six months ended June 30, 2025, the Company recorded a loss of $3.5 million related to the change in fair value of the warrant liabilities, as compared to a gain of less than $0.1 million for the six months ended June 30, 2024. The increase in loss during the six months ended June 30, 2025 was attributed to the warrants issued in conjunction with the First, Second and Third Tranches of the Anson Notes as well as increase in the Company’s fair value of its common shares.
Loss on issuance of Registered Direct Offering
For the six months ended June 30, 2025, the Company recorded a loss of $0.7 million related to the issuance of Registered Direct Offering, as compared to $0 during the six months ended June 30, 2024. As the fair value of the warrant liabilities issued in the Registered Direct Offering exceeded the net proceeds received of $3.255 million, the Company recognized the excess of the fair value over the net proceeds received of $3.255 million as a loss upon issuance of RD Shares of $0.7 million which is included in other expense (income) in the condensed consolidated statement of operations for the period ended June 30, 2025.
Loss on Considerations shares and warrants
For the six months ended June 30, 2025, the Company recorded a loss of $1.2 million related to the loss on issuance of Consideration Shares and Warrants, as compared to $0 during the six months ended June 30, 2024.
Loss on convertible note conversion
For the three months ended June 30, 2025, the Company recorded a loss of $3.5 million related to convertible note conversion, as compared to $0 during the six months ended June 30, 2024. These conversions were calculated as the difference between the conversion price per the terms of the Anson agreement (See Note 7) relative to the fair value of the common stock on the date of conversion.
Liquidity and Capital Resources
The Company has generated no revenues, has incurred operating losses since inception, expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. Until such time as the Company is able to establish a revenue stream from the sale of its therapeutic products, it is dependent upon obtaining necessary equity and/or debt financing to continue operations. The Company cannot make any assurances that sales of NRX-101 will commence in the near term or that additional financings will be available to it on acceptable terms or at all. This could negatively impact our business and operations and could also lead to the reduction of our operations.
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 to 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 June 30, 2025, the Company received aggregate net cash proceeds to the Company from the ATM Offering of approximately $2.8 million.
Cash Flows
The following table presents selected financial information and statistics for each of the periods shown below:
| June 30, 2025 |
December 31, 2024 |
|||||||
| Balance Sheet Data: |
||||||||
| Cash |
$ | 2,910 | $ | 1,443 | ||||
| Total assets |
4,838 | 3,651 | ||||||
| Convertible notes payable and accrued interest |
9,854 | 6,257 | ||||||
| Total liabilities |
40,453 | 26,874 | ||||||
| Total stockholders' deficit |
(35,615 | ) | (23,223 | ) | ||||
| Six months ended June 30, |
||||||||
| 2025 |
2024 |
|||||||
| (Unaudited) |
||||||||
| Statement of Cash Flow Data: |
||||||||
| Net cash used in operating activities |
$ | (7,508 | ) | $ | (6,233 | ) | ||
| Net cash used in investing activities |
— | — | ||||||
| Net cash provided by financing activities |
8,975 | 3,536 | ||||||
| Net increase (decrease) in cash |
$ | 1,467 | $ | (2,697 | ) | |||
Operating Activities
During the six months ended June 30, 2025, operating activities used approximately $7.5 million of cash, primarily resulting from a net loss of $23.1 million partially offset by net non-cash losses of $16.1 million, including $6.5 million in change in fair value of convertible promissory notes, $0.2 million of stock-based compensation, $3.5 million loss in convertible note conversion, $1.2 million of loss on Consideration Shares and Warrants, $0.4 million in debt issuance costs, $0.7 million in loss on issuance of Register Direct offering, $3.5 million loss in change in fair value of warrant liabilities and changes in operating assets and liabilities of $0.5 million.
During the six months ended June 30, 2024, operating activities used approximately $6.2 million of cash, primarily resulting from a net loss of $14.4 million partially offset by (a) net non-cash losses of $2.9 million, including $0.3 million in change in fair value of convertible promissory note, and $0.3 million of stock-based compensation, $1.3 million of contract costs related to Alvogen termination, $0.8 million of default penalties, and (b) changes in operating assets and liabilities of $5.3 million.
Investing Activities
During the six months ended June 30, 2025 and 2024, there was no cash used in investing activities.
Financing Activities
During the six months ended June 30, 2025, financing activities provided $9.0 million of cash resulting from $3.3 million in proceeds from issuance of common stock and warrants related to the RD Offering and $5.0 million in proceeds from the Anson Notes, $1.0 million in proceeds from issuance of common stock in connection with ATM offering, offset by $0.3 million in repayments of and by $0.4 million of proceeds from insurance notes, and $0.4 million in debt issuance costs due to the fair value election on Anson Notes.
During the six months ended June 30, 2024, financing activities provided $3.5 million of cash resulting from $1.0 million in proceeds from issuance of Common Stock and warrants issued in a private placement, and $4.7 million in proceeds from issuance of Common Stock and warrants offset by $2.2 million in repayments of the convertible note.
Contractual Obligations and Commitments
See Note 7, Debt, and Note 8, Commitments and Contingencies, of the notes to the Company’s condensed consolidated financial statements as of and for the three months ended June 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.
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 Pharmaceuticals to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the balance sheet and the reported amounts of expenses during the reporting period. In accordance with GAAP, NRx Pharmaceuticals evaluates its estimates and judgments on an ongoing basis. The most critical estimates relate to stock-based compensation, the valuation of warrants, and the valuation of convertible notes payable. NRx Pharmaceuticals bases its estimates and assumptions on current facts, historical experiences, and various other factors that NRx Pharmaceuticals believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
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.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a smaller reporting company, we are not required to provide the information required by this Item.
Item 4. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as such term is defined under Rule 13a-15(e) promulgated under the Exchange Act, designed to ensure that information required to be disclosed in our reports filed pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate to allow timely decisions regarding required disclosures.
In designing and evaluating the disclosure controls and procedures, we recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and we were required to apply our judgment in evaluating the cost-benefit relationship of possible controls and procedures. We have carried out an evaluation as of June 30, 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 June 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 June 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 8, Commitments and Contingencies, of the notes to the Company’s unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2025 (“Note 8”) 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 8, there are no additional pending or threatened legal proceedings at this time.
On May 9, 2025, Hope Therapeutics, Inc. entered into the Kadima Purchase Agreement (the “Agreement”), with HTX Management Company, LLC, Kadima Neuropsychiatry Institute, Medical Corp., Kadima Holdings, Inc., and David Feifel, M.D., PH.D. (collectively, “Kadima”), pursuant to which the Company agreed to purchase, and Kadima agreed to sell, on the Closing Date, as defined in the Agreement, certain assets of Kadima, subject to the satisfaction of certain closing conditions (the “Acquisition”). As of the date of this Report, the parties have not closed the Acquisition due to ongoing discussion between the parties, and, while no assurances can be given, remain in active discussions to either i) close the Acquisition per the terms of the Agreement, or ii) pursue potential alternative outcomes mutually agreeable to the parties.
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 “Annual Report on Form 10-K”). There have been no material changes from the risk factors previously disclosed. You should carefully consider the risk factors set forth in the Annual Report on Form 10-K and other information set forth elsewhere in this Quarterly Report on Form 10-Q. You should be aware that these risk factors and other information may not describe every risk that we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial, or may not be able to assess, also may materially adversely affect our business, financial condition and/or operating results.
There is no assurance that the Agreement with Kadima Neuropsychiatry Institute will close or that even if we close the Acquisition that we will realize the anticipated benefits.
On May 9, 2025, Hope Therapeutics, Inc. entered into an Asset Purchase and Contribution Agreement (the “Agreement”), with HTX Management Company, LLC, Kadima Neuropsychiatry Institute, Medical Corp., Kadima Holdings, Inc., and David Feifel, M.D., PH.D. (collectively, “Kadima”), pursuant to which the Company agreed to purchase, and Kadima agreed to sell, on the Closing Date, as defined in the Agreement, certain assets of Kadima, subject to the satisfaction of certain closing conditions (the “Acquisition”). As of the date of this Report, the parties have not closed the Acquisition due to ongoing discussions between the parties and, while no assurances can be given, remain in active discussions to either i) close the Acquisition per the terms of the Agreement, or ii) pursue potential alternative outcomes mutually agreeable to the parties. Even if the transactions contemplated by the Agreement are completed, the acquisition of the assets being purchased thereunder may not materialize into revenue and generate the financial and strategic benefits we expected. The failure to close the Acquisition would negatively impact our revenues and return on investment. In addition, should the Acquisition close, we may face operational challenges and unforeseen liabilities that may negatively impact our business.
While we have entered into definitive transaction documents with Kadima Neuropsychiatry Institute and Dura Medical, we cannot assure you that the transactions will be consummated or, if consummated, that they will be consummated on the terms set forth in such definitive documentation or that they will be accretive to stockholder value.
As previously reported by the Company, we entered into definitive purchase agreements with each of Kadima and Dura Medical pursuant to which we agreed to explore an acquisition of each of the clinics. We have also announced the entry into, and negotiations for, letters of intent with potential strategic investors (the “LOI’s”), to partially fund our planned acquisitions of Kadima and Dura Medical, the first step in creating our planned international network of interventional psychiatry clinics.
We currently have not finalized the commitments to finance the proposed acquisitions. Further, even if we are able to complete the financing(s), no assurances can be given that the terms will be favorable to our stockholders, that the transaction(s) will be completed in the time frame or in the manner currently anticipated, or that we will recognize the anticipated benefits of the transactions.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
No unregistered sales of equity securities occurred during the three months ended June 30, 2025, that were not previously reported.
Item 3. Defaults Upon Senior Securities
No defaults upon senior securities occurred during the three months ended June 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 June 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 June 30, 2025.
Item 6. Exhibits
| Exhibit Number |
Description |
|
| 10.1+ | Asset Purchase and Contribution Agreement, dated as of May 9, 2025, by and among Hope Therapeutics, Inc. and the signatories thereto (incorporated by reference to Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q, filed on May 15, 2025. | |
| 10.2+ | Membership Interest Purchase and Contribution Agreement, by and among Hope Therapeutics, Inc. and the signatories thereto (incorporated by reference to Exhibit 10.7 to the Company’s Quarterly Report on Form 10-Q, filed on May 15, 2025. | |
| 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: August 15, 2025 |
By: |
/s/ Jonathan Javitt |
| Chairman and Interim Chief Executive Officer |
||
| (Principal Executive Officer) |
||
FAQ
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What material liabilities or losses were recorded?
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