Trooperstocks
6 días hace
$NRXP NEWS: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reschedules Conference Call to Discuss Third Quarter and Year to Date 2024 Financial Results to November 18, 2024
PR Newswire
Wed, November 13, 2024 at 8:03 AM EST 4 min read
In This Article:
NRXP
WILMINGTON, Del., Nov. 13, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will reschedule its third quarter and year to date 2024 results conference call to Monday November 18, 2024 at 4:30pm ET, to accommodate any additional corporate news.
A live webcast of the conference call will be available on the Company's website at https://ir.nrxpharma.com/events. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically +1-800-717-1738 or internationally +1-646-307-1865.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a healthcare delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
For further information:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
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SOURCE NRx Pharmaceuticals, Inc.
Trooperstocks
3 semanas hace
$NRXP NEWS: HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Signing of a Letter of Intent to Acquire its First Florida Interventional Psychiatry Clinics
- The clinics are located in favorable locations, are revenue generating and EBITDA positive
- Clinics offer a comprehensive range of mental health services
- Acquisition is expected to be immediately accretive to revenue and EBITDA for HOPE and NRx
MIAMI, Oct. 30, 2024 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), a medical and technology driven company, and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP), today announced signing a non-binding Letter of Intent (LOI) for acquisition of its first Interventional Psychiatry Clinics in Florida. These clinics are seen as top performers and will form the Company's foundation for growth in Florida.
The clinics to be acquired are revenue generating and EBITDA positive, thus the acquisition is expected to be immediately accretive to both revenue and EBITDA for HOPE and NRx.
"These clinics come to us highly recommended by industry insiders, and we have been impressed with their intelligent and compassionate operations," said Jonathan Javitt, MD MPH and Matthew Duffy, Co-CEOs of HOPE Therapeutics. "Additionally, we look forward to working with the founders to help optimize additional acquisitions as they enter our network. This is another important step forward as we move to establish HOPE as a model for clinics that aim to provide the latest standard of care treatments for CNS healthcare providers nationwide."
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a healthcare delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
For further information:
CORPORATE CONTACT:
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-CEO, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
SOURCE NRx Pharmaceuticals, Inc.
https://ir.nrxpharma.com/2024-10-30-HOPE-Therapeutics,-Inc-and-NRx-Pharmaceuticals,-Inc-Nasdaq-NRXP-Announce-Signing-of-a-Letter-of-Intent-to-Acquire-its-First-Florida-Interventional-Psychiatry-Clinics
#PharmaNews #mentalhealth #depression #ketamine #PTSD #bipolar $NRXP
Trooperstocks
2 meses hace
News: NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announces Completion of Twelve Months of Stability on the First Manufactured Commercial Scale Lot of NRX-100 (Ketamine)
PR Newswire
Mon, September 30, 2024 at 7:00 AM EDT 5 min read
In This Article:
NRXP
+2.86%
Stability milestone supports submission of FDA New Drug Application by NRx for the use of intravenous ketamine to treat Suicidal Depression
Ketamine is currently used off-label for this indication. However, FDA approval is typically required for patients to obtain insurance reimbursement
NRX-100 is the first preservative-free formulation of Ketamine, potentially avoiding toxic side effects of preservatives used in current preparations designed for single dose anesthetic use
RADNOR, Pa., Sept. 30, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, ("NRx," the "Company"), today announced that twelve-month real-time stability on the first manufactured lot of NRX-100 (Ketamine) at Nephron Pharmaceuticals, utilizing commercial scale processes, was reached on September 24, 2024. In this process, no degradation of the active ingredient was observed. These findings are consistent with projected room temperature shelf stability in excess of three years. Accelerated stability on additional manufactured lots of preservative-free product is congruent with stability seen in this initial lot.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
Demonstrating the ability to manufacture drug product, and prove its stability, are critical components of the drug approval process with the US FDA. Filing of the NDA for NRX-100 is on track for 2024. The NRX-100 formulation is the first sterile, single dose vial prepared with without the addition of preservatives, which may have toxic effects with repeated use.
"We are pleased to reach this important milestone in our preparation of the NDA for NRX-100, a drug we believe can significantly benefit the 3.8 million people who make a plan to commit suicide in the United States each year1," said Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx Pharmaceuticals. "I would like to congratulate the manufacturing team from our partner Nephron Pharmaceuticals for helping us take this important step forward in bringing hope to life."
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 inpatients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
CORPORATE CONTACTS:
Jeremy Feffer, LifeSci Advisors, Inc.
jfeffer@lifesciadvisors.com
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-CEO, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
_________________________
1 https://www.cdc.gov/suicide/facts/data.html
Cision
Cision
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SOURCE NRx Pharmaceuticals, Inc.
ProfitScout
2 meses hace
$NRXP News: NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Featured on Psychiatrist.com
"How NRx Could Upend the Fight Against Depression and Suicide"
RADNOR, Pa., Sept. 11, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, ("NRx," the "Company"), today highlighted that the Company's pipeline products NRX-100 and NRX-101 were featured in an article published on Psychiatrist.com. This prominent outlet is the home of the Journal of Clinical Psychiatry, the official journal of the American Society of Clinical Psychopharmacology.
The article, entitled "How NRx Could Upend the Fight Against Depression and Suicide," can be found here. The author notes:
"Clinical relevance: NRX Pharmaceuticals is developing a pair of promising new treatments for bipolar depression and suicidal ideation."
"NRX-101 is a twice-daily fixed-dose oral combination of D-cycloserine and lurasidone the company developed to treat suicidal treatment-resistant bipolar depression. Researchers found this combination showed a higher efficacy than lurasidone alone for reducing akathisia and suicidality."
"NRX-100 is a proprietary preservative-free formulation of IV ketamine. Researchers have studied it as a treatment for acute suicidal crises in depression."
For more information, please visit hppt://www.nrxpharma.com.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
For further information:
CORPORATE CONTACTS:
Jeremy Feffer, LifeSci Advisors, Inc.
jfeffer@lifesciadvisors.com
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-CEO, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
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SOURCE NRx Pharmaceuticals, Inc.
Trooperstocks
3 meses hace
News: HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Potential Acquisition and Financing Agreements for $30 Million in Currently-Operating Interventional Psychiatry Clinics
PR Newswire
Mon, Aug 26, 2024, 7:55 AM EDT
In this article:
NRXP
+1.96%
NRXPW
+35.91%
$30 million Term Sheet from qualified lender for non-dilutive financing for first clinic acquisitions; anticipated closing within 60 days
Executed Non-Binding Term Sheet with initial clinic partners generating annual revenue of over $10 million, with additional partners to be selected under this initial funding agreement
Company projects annualized revenues of $100 million through continued acquisition by mid 2025
Additional information to be presented at upcoming HC Wainwright Annual Global Investment Conference in New York, September 9-11, 2024
MIAMI, Aug. 26, 2024 /PRNewswire/ -- HOPE Therapeutics, Inc., a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("HOPE," the "Company"), a medical and technology driven company, today announced signing a non-binding Term Sheet for non-dilutive, nonconvertible debt acquisition funding of its first interventional psychiatry clinics (ketamine clinic acquisitions), together with the signing of a Term Sheet for five currently operational clinics in the Western United States. In addition to the currently-signed non-binding Term Sheet, the Company has been offered non-binding lending commitments it believes are sufficient to assemble/acquire a network of operational clinics with revenues in excess of $100 million. The Company anticipates potential operations in the United States, France, and the United Kingdom.
The non-dilutive acquisition funding announced today is in addition to the over $60 million in potential equity funding previously offered upon public listing of HOPE Therapeutics shares on a public exchange.
Ketamine is increasingly used to treat suicidal depression, treatment resistant depression (TRD) and Post Traumatic Stress Disorder (PTSD). Until now there has been no unified entity organized around delivering consistent outpatient care for suicidal depression, TRD and PTSD that combines pharmaceutical therapy, FDA approved and proven medical technologies such as Transcranial Magnetic Stimulation (TMS), digital therapeutics and access to clinical trial protocols for the newest potential treatments, delivered by properly licensed medical professionals to optimize care of people with these conditions. Collectively, these conditions represent a crisis that results in the death of someone around the globe every minute. HOPE aims to bring a unified, patient-centric and science-based approach to the care of patients and their families.
"HOPE is dedicated to providing an accessible platform to help caregivers address the critical needs of those suffering from suicidal thoughts, TRD, PTSD and related challenges. We are delighted to take the critical first steps towards developing a network of clinics that can provide the highest possible level of care and demonstrate best-practices for mental health professionals around the world," said Jonathan Javitt and Matthew Duffy, Co-CEOs of HOPE Therapeutics. "These clinics, and others under review, are planned to provide the foundation for a network generating revenue of approximately $100 million annually in the coming year."
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a healthcare delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE NRx Pharmaceuticals, Inc.
ProfitScout
3 meses hace
NRx Pharmaceuticals (NASDAQ:NRXP) Reports Second Quarter and Year to Date 2024 Financial Results and Provides Business Update
Company is now funded for and focused on New Drug Applications (NDAs) for NRX-100 (ketamine) and NRX-101
Audit of HOPE Therapeutics is now complete, SEC filing of spinout this quarter
Key Milestones
Secured $10.8 - $16.3 million in convertible-debt funding from an institutional investor; funds targeted to support FDA New Drug Applications for NRX-100 (ketamine) and NRX-101. Replacement funding entails substantial reduction in interest rate, conversion discount, and other financial terms compared to prior debt
Retirement of Streeterville debt and settlement of litigation at a substantial discount to litigation claims
NRX-100 NDA for suicidal depression based on data from four clinical trials in nearly 1000 participants demonstrating highly significant efficacy compared to placebo, active comparator, and electroshock therapy
Ketamine findings have just been confirmed in published 43,000 person cohort study1
Phase 2b/3 trial of NRX-101 in suicidal patients with bipolar depression demonstrated depression efficacy comparable to standard of care and significant reduction of akathisia (P=0.025) and time to sustained remission from suicidality (P=.05). Presented at the annual meeting of the American Society of Clinical Psychopharmacology. Profile demonstrates possible best in class bipolar depression medication
Company plans to file a New Drug Application (NDA) for Accelerated Approval under Breakthrough Therapy Designation and Priority Review of NRX-101 in treatment of bipolar depression in people akathisia or suicidality, based on the Phase 2b/3 and STABIL-B data
Stability data continues to mature on the three manufacturing lots required for the NRX-100 (IV ketamine) NDA filing and the Company announced alignment with FDA on its Pediatric Study Plan for NRX-100, also a requirement for filing an NDA
HOPE Therapeutics, the Company's wholly owned subsidiary, is focused on developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders. HOPE is planned to be spun out as a separate company to be owned by NRx, current NRx shareholders, and new investors. This effort will be funded apart from NRx.
Appointed Dr. Dennis McBride, a Neuroscience, Information Technology and Medical Technology Veteran, to its Board of Directors
Management to host a conference call August 14, 2024, at 4:30 PM ET
RADNOR, Pa., Aug. 14, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter and year to date ended June 30, 2024, and provided a business update.
"NRx has continued to execute on our plans to file two NDA's this year. As we near maturation of NRX-100 stability data, we also achieved an important milestone in aligning with FDA on our pediatric study plan. Together with strong clinical data from four clinical trials, we believe this application will be quite robust. Additionally, the important data generated from two trials conducted by NRx with NRX-101 in suicidal bipolar depression sets the stage for a second NDA for Accelerated Approval later this year. Finally, work continues to spin out Hope Therapeutics and distribute shares to NRx stockholders. We believe reaching these important milestones will generate significant value in the company and reward our shareholders," said Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx Pharmaceuticals. "Facilitated by funding to allow us to achieve these goals and while replacing the prior expensive and toxic debt on our balance sheet, we are in a position to deliver therapy that can meet considerable unmet medical need in millions of patients across the country. We are dedicated to bringing hope to life and I thank our team and shareholders for their ongoing hard work and support."
Second Quarter Clinical, Regulatory and Corporate Highlights
Funding for FDA filings of NRX-100 and NRX-101
The Company has executed a Convertible Debt instrument with Anson Funds of Toronto for $10.8 - $16.3 million in funding designed to retire existing debt and to support FDA New Drug filings of NRX-100 and NRX-101 in the fourth quarter of 2024. Terms have been disclosed in 8K filings but are at an interest rate and conversion rate substantially lower than current corporate indebtedness. The new funding has no provision for "extraordinary redemptions" triggered by appreciation in NRx share price.
Retirement of current debt and settlement of litigation
Concurrent with the Anson investment, the Company has settled its outstanding litigation with Streeterville Capital, LLC at a substantial discount to the amounts claimed in litigation.
Progress towards an NDA for NRX-100 (IV ketamine) in the treatment of suicidal depression
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 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 (SSI) at day 1 (p=0.0003) and in depression (P=0.0234), as measured by the Profile of Mood States (POMS) among patients randomized to IV Ketamine compared to those randomized to midazolam. This trial was published in the American Journal of Psychiatry Grunebaum, et.al.2. Abbar and colleagues similarly published 84% remission from suicidality on the Columbia Suicide Severity Rating Scale (C-SSRS) in patients treated with ketamine, vs. 28% in those treated with placebo (P
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NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Report Second Quarter and Year to Date 2024 Financial Results on August 14, 2024
RADNOR, Pa., Aug. 13, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its second quarter and year to date 2024 financial results after the market closes on Wednesday, August 14, 2024, via press release, which will be available on the Company's website at https://ir.nrxpharma.com/. The Company will host a conference call to discuss the financial results as well as provide a corporate update at 4:30pm ET the same day.
A live webcast of the conference call will be available on the Company's website at https://ir.nrxpharma.com/events . Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically +1-800-717-1738 or internationally +1-646-307-1865.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a care delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
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SOURCE NRx Pharmaceuticals, Inc.
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$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Up to $16 Million Senior Secured Debt Financing from Anson Funds
This financing is expected to support 2024 filing of New Drug Applications forNRX-100 (ketamine) and NRX-101 and to support launch of HOPE Therapeutics
Streeterville Capital has agreed to a settlement of all claims to be paid from the proceeds of this financing
RADNOR, Pa., Aug. 13, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced that it has obtained up to approximately $16 million in convertible debt financing (the "Financing") from an institutional investor. The Company intends to use the net proceeds from the Financing to support the 2024 New Drug Application filing its two lead products, NRX-100 and NRX-101 and to retire existing debt from Streeterville Capital. Concurrent with this financing, Streeterville has agreed to stay its arbitration and to release all claims upon receipt of the agreed settlement funds. The interest rate and other costs of capital are substantially lower than prior debt.
"We are thrilled to have attracted a forward-looking science-focused investor to our company. The proceeds from their investment will support our FDA filing of two lifesaving drugs that address critical unmet medical needs for patients with suicidal depression. In the process, we are retiring problematic debt from our balance sheet on favorable terms, and at a lower annual interest rate," said Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx Pharmaceuticals. "We are pleased to welcome Anson Funds to NRx Pharmaceuticals and delighted that they have chosen to share our mission of bringing Hope to Life."
"NRx Pharmaceuticals has a promising pipeline with potential to transform the lives of patients and their loved ones. We are pleased to be working with the NRx Pharmaceuticals team to support these drugs in their registration and – hopefully – approval phase," said Amin Nathoo, Principal, Anson Funds.
The Notes have an interest rate of 6% per annum with a term of 15 months and will be convertible into shares of the Company's common stock. The investors will receive warrant coverage equivalent to 50% of their investment, exercisable into shares of the Company's common stock. The conversion price of the Notes and the exercise price of the Warrants will be each subject to customary adjustments and adjustments for certain corporate transactions, and the issuance of shares of Common Stock underlying the Notes and Warrants will be subject to stockholder approval as required by the listing rules of the Nasdaq Capital Market. The Company will file a Current Report on Form 8-K with the U.S. Securities and Exchange Commission, which will describe the terms of the Notes and Warrants, and include copies of transaction documents relating to the Notes, the Warrants and the Financing.
EF Hutton LLC acted as the exclusive placement agent for the Financing.
The Notes and Warrants have not been registered under the Securities Act of 1933, as amended, and may not be resold in the United States except pursuant to an effective registration statement with the Securities and Exchange Commission or an exemption from registration under the Securities Act and any applicable state securities laws.
This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx Pharmaceuticals has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx Pharmaceuticals was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (http://www.hopetherapeutics.com) is a care delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which involve substantial risks and uncertainties. Forward-looking statements are often identifiable by the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "predict," "project," "potential," "should," "will," or "would," or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although the Company believes that it has a reasonable basis for making each forward-looking statement contained in this press release, the Company cautions that these statements are based on a combination of facts and factors currently known by the Company and its expectations of the future, about which the Company cannot be certain. Forward-looking statements are subject to considerable risks and uncertainties, as well as other factors that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks and uncertainties include, without limitation, risks and uncertainties related to whether or not the Company will be able to raise capital through the sale of its securities; the Company's ability to consummate the offering; the Company's ability to repay the Note; the Company being able to fulfill the conditions for a second closing and a third closing and receive the remainder of the financing amount; the Company being able to receive the consent of its stockholders to the Financing; market conditions; satisfaction of customary closing conditions related to future closings; the Company's ability to maintain adequate liquidity and financing sources; various risks related to the Company's business operations; and other risks and uncertainties, including those described within the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, and other filings with the Securities and Exchange Commission.
Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE NRx Pharmaceuticals, Inc.
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$NRXP News: HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Alignment with FDA on Pediatric Study Plan for NRX-100 (ketamine)
FDA response highlights the importance of addressing suicidal depression in adolescents age 9-17
Alignment on initial Pediatric Study Plan (iPSP) is a gating requirement for the upcoming filing of an NRX-100 New Drug Application (NDA) for suicidal depression
NRx remains on track to file the NDA for NRX-100 in Q4 2024 with anticipated PDUFA date in Q2 2025
RADNOR, Pa., July 29, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced a communication from the US Food and Drug Administration (FDA) providing feedback and alignment on NRx's proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment of suicidal depression. Congress required the submission of an iPSP as a precondition to filing a New Drug Application in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).[1]
Suicide is a growing crisis among adolescents in the United States. According to the US Centers for Disease Control, 10% of high school students attempted suicide in the past year and 22% of high school students reported having seriously considered suicide. This percentage is highest among females (30%), American Indians/Alaska Natives (27%), and lesbian, gay, or bisexual teens (45%) (CDC, 2023). [2]
In support of its upcoming NDA filing, NRx will be submitting existing data supporting the safety and efficacy of ketamine to treat suicidal depression in adults. FDA has now documented its recognition that suicide is a serious and growing public health concern in adolescents as well. Based on the guidance received, NRx and HOPE Therapeutics will commit to conducting a clinical trial of NRX-100 in adolescents aged 9-17 with suicidal depression, but will not be required to study the effects of NRX-100 in younger age groups, following initial approval of NRX-100 in adults. Additional neurotoxicity studies will be conducted in juvenile animal subjects to support the safety of intravenous ketamine in this younger population.
"Youth suicide has reached crisis proportions in the United States with a 62% increase over the past two decades, disproportionately affecting minorities.[3] We appreciate FDA's recognition of the urgent unmet medical need related to suicidal depression in adolescents and look forward to expanding the mission of NRx and HOPE Therapeutics to serve America's youth in preventing needless deaths from suicidal depression, said Prof. Jonathan Javitt, Chairman of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics."
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a care delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
1 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/Pediatric-Study-Plans--Content-of-and-Process-for-Submitting-Initial-Pediatric-Study-Plans-and-Amended-Pediatric-Study-Plans.pdf
2 https://www.cdc.gov/healthyyouth/data/yrbs/pdf/YRBS_Data-Summary-Trends_Report2023_508.pdf
3 https://www.apa.org/monitor/2023/07/psychologists-preventing-teen-suicide
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SOURCE NRx Pharmaceuticals, Inc.
Trooperstocks
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NEWS: HOPE Therapeutics, Inc. and NRx Pharmaceuticals (Nasdaq:NRXP) Announce Arbitration Order Enabling HOPE Therapeutics Spinoff | NASDAQ
PUBLISHED
JUL 29, 2024 8:30AM EDT
Petition for a temporary restraining order brought by Streeterville Capital, LLC seeking injunctive relief to prevent spinoff of 49% of HOPE Therapeutics shares to current NRx Shareholders has been denied by Utah arbitrator.
Petition by Streeterville Capital, LLC seeking injunctive relief to prevent sales of NRx shares has been denied by Utah arbitrator.
NRx to proceed with spinoff of HOPE Therapeutics as previously announced.
RADNOR, Pa., July 29, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced the issuance of an order by a Utah arbitrator denying the petition of Streeterville Capital, LLC to enjoin NRx's planned spinoff of 49% of the shares in HOPE Therapeutics to current shareholders of NRx pharmaceuticals. While the proposed spinoff remains subject to compliance with certain disclosure and other requirements under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, the spinoff is intended to provide NRx shareholders with an opportunity to participate in the anticipated value created as a result of the spinoff and to enable a potential listing of HOPE Therapeutics (currently a wholly-owned subsidiary of NRx) on a national securities exchange. The arbitrator also denied Streeterville's petition to enjoin NRx from selling additional shares of NRx stock to finance ongoing operations.
(PRNewsfoto/NRx Pharmaceuticals)
"As we have previously shared with the public, HOPE Therapeutics is in the process of developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression. This arbitration decision enables us to keep our promise to shareholders to spin out 49% of HOPE Therapeutics shares held by NRx to our shareholders, subject to approval by our Board of Directors and compliance with applicable law. We appreciate the support and loyalty of our shareholders as we work to bring HOPE to life," said Prof. Jonathan Javitt, Founder and Chairman of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a care delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
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SOURCE NRx Pharmaceuticals, Inc.
https://www.nasdaq.com/press-release/hope-therapeutics-inc-and-nrx-pharmaceuticals-nasdaq-nrxp-announce-arbitration-order #NRxPharma #News
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5 meses hace
$NRXP News: NRx Pharmaceuticals (NASDAQ:NRXP) to Proceed with Two New Drug Applications in 2024; NRX-101 has Been Returned to the Company for Filing
New Drug Application (NDA) for Accelerated Approval planned for NRX-101 in people with bipolar depression and akathisia in 2024, based on two positive trials 1 2 and Breakthrough Therapy Designation. Potential revenue in 2025
NDA for NRX-100 (IV ketamine) in suicidal depression in advanced preparation for submission in 2024; based on four positive trials 3 4 5 6 and Fast Track Designation. Potential revenue in 2025
Gaining these approvals has the potential to yield more than $150 in revenue per NRXP share in the near term, at current share count
Planning for HOPE Therapeutics share distribution progresses; audit nearing completion – critical step towards a public listing
RADNOR, Pa., June 28, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that advice from regulatory counsel, which includes former senior officials from the Food and Drug Administration, supports filing two New Drug Applications (NDAs) in 2024: an application for Accelerated Approval for NRX-101 to treat bipolar depression in patients with akathisia and an application for approval of NRX-100 (IV ketamine) for treatment of suicidal depression.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
While efficacy and safety data are now in hand, filing of the above applications is dependent upon completion of 12-month stability data in manufactured lots as required by FDA regulations.
As disclosed in an 8K filing, NRx will be filing the NRX-101 application without a commercial partner. The addressable market for the accelerated approval indication is such that a compact and efficient salesforce can be constructed by a small company, such as NRx, and current executives at NRx have previously held primary responsibility for launch of similar-sized pharmaceutical assets.
NRx continues work to enable the distribution of shares in Hope Therapeutics. This distribution is dependent upon completion of a public audit and successful review of an SEC Form 10.
"The NRx team has worked diligently since the end of the COVID pandemic to achieve these milestones for our shareholders and most importantly the patients we have always sought to help," said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. "Given the near-term market opportunity represented by an accelerated approval process, NRx anticipates a higher potential return to NRx investors associated with an NRx-led initiative than that which would likely be achieved with a large commercial partner."
NRX-101 for Bipolar Depression
NRX-101 is the Company's patented (Composition of Matter), oral combination of the NMDA antagonist D-cycloserine and lurasidone for bipolar depression. Data from two active control clinical trials vs. the standard of care, lurasidone, have shown comparable antidepressant efficacy with clinically important reductions in suicidality and/or akathisia. To the Company's knowledge, no other oral agent has demonstrated such a valuable profile.
Up to 15% of people treated with drugs in lurasidone's class develop akathisia7; this would constitute an estimated $3.7 billion initial market for NRX-101, with no approved medicines for akathisia. This is a population the Company can readily address without a large commercial partner, given the relatively small number of psychiatrists who treat high-risk patients. The broad bipolar market constitutes 7 million people and an opportunity greater than $20 billion per year. With a best-in-class product profile, the Company projects NRX-101 sales in excess of $2 billion.
NRX-101 was awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of suicidal bipolar depression.
NRX-100 (IV ketamine) for Suicidal Depression
Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by FDA is electroconvulsive therapy (ECT).
According to the CDC, 3.5 million Americans make a plan for suicide each year.8 This represents a $3-5 billion market at expected pricing.
Based on the data in the trials referenced above, the Company's regulatory counsel has encouraged the Company to file an NDA for suicidal depression for NRX-100. This application has been in development and awaits 12-month stability data for filing, which is expected in 2024.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreements. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
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, STABIL-B
2 Nierenberg, et. al., A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior. Am Soc Clin Psych Annual Meeting 2024. ASCP Poster
3 Fava, M et. al., Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD) Mol Psychiatry. 2020; 25(7): 1592–1603.
4 Grunebaum, et. al., Ketamine for Rapid Reduction of Suicidal Thoughts. Am J Psychiatry. 2018 Apr 1: 175(4): 327-335
5 Abbar, et. al. Ketamine for Acute Treatment of Severe Suicidal Ideation, BMJ 2022; 376
6 Anand, et. al, Ketamine is non-inferior to ECT for non-psychotic treatment resistant depression. NEJM 2023 388(25):2315-2325
7 Chow, C, et. Al., Akathisia and Newer Second-Generation Antipsychotic Drugs: A Review of Current Evidence
Pharmacotherapy 2020;40(6):565–574
8 CDC Suicide Data.
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
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View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-to-proceed-with-two-new-drug-applications-in-2024-nrx-101-has-been-returned-to-the-company-for-filing-302185390.html
SOURCE NRx Pharmaceuticals, Inc.
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