1. GENEVA, SWITZERLAND / ACCESSWIRE / October 15, 2021 / RELIEF THERAPEUTICS Holding SA ((SIX:RLF, OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) (" NRx "), has issued a press release announcing that the peer-reviewed Journal of Infectious Diseases and Treatment has published positive trial data from a prospective, open label, administratively controlled trial of aviptadil in high comorbidity patients suffering from critical COVID-19 with respiratory failure. According to the press release, the study reported 60-day survival in 81% of…

    GENEVA, SWITZERLAND / ACCESSWIRE / October 15, 2021 / RELIEF THERAPEUTICS Holding SA ((SIX:RLF, OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) (" NRx "), has issued a press release announcing that the peer-reviewed Journal of Infectious Diseases and Treatment has published positive trial data from a prospective, open label, administratively controlled trial of aviptadil in high comorbidity patients suffering from critical COVID-19 with respiratory failure. According to the press release, the study reported 60-day survival in 81% of those treated with aviptadil, compared to 21% survival among those who received standard of care treatment at the Houston Methodist Hospital (P<.0001). The press release also reports that a similar 9-fold advantage was seen in the cumulative probability of recovery from respiratory failure (P<.0001). The related NRx press release can be accessed through the following link .

    https://www.accesswire.com/users/newswire/images/667866/Relieflogo.gif

    ABOUT RELIEF

    Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

    RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com . Follow us on LinkedIn.

    CONTACT:
    RELIEF THERAPEUTICS Holding SA
    Jack Weinstein
    Chief Financial Officer and Treasurer
    contact@relieftherapeutics.com

    FOR MEDIA/INVESTOR INQUIRIES:
    Rx Communications Group
    Michael Miller
    +1-917-633-6086
    mmiller@rxir.com

    Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    SOURCE: Relief Therapeutics Holdings AG



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  2. RADNOR, Pa., Oct. 14, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ:NRXP), today announced the publication of peer-reviewed results from a prospective, open-label, administratively controlled trial of aviptadil for the treatment of respiratory failure in patients with Critical COVID-19. The study reported 60-day survival in 81% of those treated with aviptadil, compared to 21% survival among those who received standard of care treatment at the Houston Methodist Hospital (P<.0001). A similar 9-fold advantage was seen in the cumulative probability of recovery from respiratory failure (P<.0001). The study appears in the Journal of Infectious Diseases and Treatment.

    "We view this study as supportive evidence that aviptadil protects the lung against the lethal effects of the SARS-CoV-2 virus," said Jihad Georges Youssef, M.D., Lead Author of the study.

    Patients enrolled in this study were at the highest possible risk for death based on serious comorbidities that rendered them ineligible for participation in the phase 2b/3 pivotal study of aviptadil for the treatment of COVID-19 with respiratory failure. In addition, patients in the study failed to respond to all treatments approved for COVID-19 during the first surge of the pandemic in the summer of 2020.

    In addition to the substantial differences seen for both survival and recovery, the study demonstrated statistically significant advantages in the aviptadil-treated group on two important intermediate endpoints: Respiratory Distress Ratio and Cytokine IL-6. Statistically significant differences on these endpoints have previously been noted in reports from the phase 2b/3 randomized controlled trial of aviptadil vs. placebo conducted at 10 sites across the United States. Aviptadil-treated participants in this open-label study demonstrated a rapid (48-96 hour) 2-fold improvement in the Respiratory Distress Ratio (RDR- a measure of the lung's ability to transmit oxygen to the blood), whereas no short-term improvement was seen in patients who were treated with standard of care (P<0001). A 100% reduction in cytokine IL-6 was also seen in aviptadil-treated patients (along with changes in other cytokines). It was not possible to compare the cytokine reduction to standard of care-treated participants because of the low survival in this control group.

    "Although randomized, placebo-controlled trials are the gold standard for medical evidence, the findings in this open-label study are remarkably similar to those seen at tertiary care medical centers in the phase 2b/3 trial of aviptadil vs. placebo. Therefore, we view this study as supportive evidence that aviptadil protects the lung against the lethal effects of the SARS-CoV-2 virus," said Jihad Georges Youssef, M.D., Medical Director of Advanced Lung Diseases Program at Houston Methodist J. C. Walter Jr. Transplant Center and lead author on the study. "The patients enrolled in this trial had no therapeutic alternatives and 80% of those treated with standard of care died within 60 days of hospital admission. The corresponding improvement in RDR and cytokine levels add biologic plausibility to the findings. We believe these add important perspective to the potential for aviptadil to help some of the sickest patients with Critical COVID-19 recover and return home to their families."

    The primary endpoint was survival as measured by Kaplan Meier life table, with Recovery from Respiratory Failure, World Health Organization 10-point ordinal scale, and PaO2: FiO2 ratio while on a ventilator as secondary endpoints. As required in the CONSORT description, no additional resources were added or removed from the usual care setting other than treatment or non-treatment with aviptadil.

    The study team enrolled Standard of Care patients between May 23 and August 15, 2020, in intensive care units (ICU) of the Houston Methodist Hospital System, in Houston, Texas. All patients enrolled in the trial had Critical COVID-19 with respiratory failure. All patients in the study were treated by the same ICU team (regardless of admitting team) and received maximally available therapy, which included steroids, anti-coagulants, remdesivir, and, in some cases, convalescent plasma, with the test group receiving aviptadil.

    No unexpected drug-related Serious Adverse Events (SAEs) were recorded. Hypotension was seen in two patients that were successfully managed, and treatment with aviptadil was continued. Diarrhea was observed in 4 aviptadil-treated patients, compared to 3 control patients (19% vs. 10%; p=0.2). These adverse events are congruent with those seen in the Phase 2b/3 randomized clinical trial of aviptadil in Critical COVID-19 patients.

    About ZYESAMI™ (aviptadil) in COVID-19

    Aviptadil is a synthetic form of Vasoactive Intestinal Polypeptide (VIP), first discovered by the late Prof. Sami Said in 1970, and ZYESAMI™ is named in his honor. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.

    COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the ATII cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). VIP is shown to upregulate surfactant production, block Coronavirus replication in the ATII cell, block cytokine synthesis, and prevent viral-induced cell death (cytopathy). Other than ZYESAMI™, no currently proposed treatments for COVID-19 specifically target this mechanism of action.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management. 

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 



     

    NRx Media Contact:

    Jack Hirschfield

    Head of External Affairs



    (512) 674-5163



    Email: jhirschfield@nrxpharma.com







    John Mulally

    Investor Relations



    (617) 429-3548



    Email: jmulally@lifesciadvisors.com

     

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    SOURCE NRx Pharmaceuticals

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  3. GENEVA, SWITZERLAND / ACCESSWIRE / October 13, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) ("NRx"), has issued a press release announcing they have submitted a revised Investigational New Drug module on the manufacturing of ZYESAMI(TM) (aviptadil) to the U.S. Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. According to the press release, NRx has also received notification that…

    GENEVA, SWITZERLAND / ACCESSWIRE / October 13, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) ("NRx"), has issued a press release announcing they have submitted a revised Investigational New Drug module on the manufacturing of ZYESAMI(TM) (aviptadil) to the U.S. Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. According to the press release, NRx has also received notification that a European QP (Qualified Person) Auditor has completed an inspection at a separate manufacturing facility with no adverse findings. The related NRx press release can be accessed through the following link.

    https://www.accesswire.com/users/newswire/images/608019/21211.png

    ABOUT RELIEF

    Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

    RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

    CONTACT:

    RELIEF THERAPEUTICS Holding SA
    Jack Weinstein
    Chief Financial Officer and Treasurer
    contact@relieftherapeutics.com

    FOR MEDIA/INVESTOR INQUIRIES:
    Rx Communications Group
    Michael Miller
    +1-917-633-6086
    mmiller@rxir.com

    Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RELIEF THERAPEUTICS Holding SA will prevail in its litigation action against NeuroRx over the terms of the Collaboration Agreement, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    SOURCE: Relief Therapeutics Holdings AG



    View source version on accesswire.com:
    https://www.accesswire.com/667866/Relief-Reports-that-its-US-Collaboration-Partner-has-Announced-Progress-on-Worldwide-Commercial-Scale-Development-of-ZYESAMITM-aviptadil

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  4. RADNOR, Pa., Oct. 12, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP), today announced that a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) was submitted to the US Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. This module will now be used as part of the FDA's rolling review process supporting the New Drug Application for ZYESAMI.

    As thousands of people around the world continue to die each day from COVID-19, we are continuing our efforts to ensure that NRx has the supply and logistics in place to provide ZYESAMI to patients where it is granted regulatory approval," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx.

    NRx has also received notification that a European QP (Qualified Person) Auditor has completed an inspection at a separate manufacturing facility with no adverse findings. NRx awaits a QP Declaration that is required by the EU regulatory authorities for the release of ZYESAMI. The audit was completed in preparation for submission of European Union (EU)-standard ZYESAMI to EU and United Kingdom health regulatory authorities. Under EU law, a QP Auditor is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU or imported into the EU.

    "As thousands of people around the world continue to die each day from COVID-19, we are continuing our efforts to ensure that NRx has the supply and logistics in place to provide ZYESAMI to patients where it is granted regulatory approval," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx.

    About ZYESAMI™/VIP in COVID-19

    Aviptadil is a synthetic form of Vasoactive Intestinal Polypeptide (VIP), first discovered by the late Prof. Sami Said in 1970, and ZYESAMI™ is named in his honor. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood.  Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.

    COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the ATII cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). VIP is shown to upregulate surfactant production, block Coronavirus replication in the ATII cell, block cytokine synthesis, and prevent viral-induced cell death (cytopathy). Other than ZYESAMI™, no currently proposed treatments for COVID-19 specifically target this mechanism of action.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management. 

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary





     

    NRx Media Contact

    Jack Hirschfield

    Head of External Affairs



    (512) 674-5163



    Email: jhirschfield@nrxpharma.com







    John Mulally

    Investor Relations



    (617) 429-3548



    Email: jmulally@lifesciadvisors.com

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-progress-on-worldwide-commercial-scale-development-of-zyesami-aviptadil-301397710.html

    SOURCE NRx Pharmaceuticals

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  5. GEVENVA, SWITZERLAND / ACCESSWIRE / September 30, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) ("NRx"), has issued a press release providing a safety update on ZYESAMI(TM) (RLF-100(TM)/aviptadil) which is being tested in the ACTIV-3b/TESICO (Therapeutics for Severely Ill Inpatients with COVID-19) phase three study sponsored by the National Institutes of Health (NIH). According to the press release, in its second scheduled analysis, the study's Independent Data Safety Monitoring Board…

    GEVENVA, SWITZERLAND / ACCESSWIRE / September 30, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) ("NRx"), has issued a press release providing a safety update on ZYESAMI(TM) (RLF-100(TM)/aviptadil) which is being tested in the ACTIV-3b/TESICO (Therapeutics for Severely Ill Inpatients with COVID-19) phase three study sponsored by the National Institutes of Health (NIH). According to the press release, in its second scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of 231 patients and recommended continued enrollment. The related NRx press release can be accessed through the following link.

    ABOUT RELIEF

    Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

    RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

    CONTACT:

    RELIEF THERAPEUTICS Holding SA
    Jack Weinstein
    Chief Financial Officer and Treasurer
    contact@relieftherapeutics.com

    FOR MEDIA/INVESTOR INQUIRIES:

    Rx Communications Group
    Michael Miller
    +1-917-633-6086
    mmiller@rxir.com

    Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether RLF-100TM (aviptadil) will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19, (ii) whether RELIEF THERAPEUTICS Holding SA can satisfactorily resolve its ongoing disputes with NeuroRx without litigation, (iii) whether RELIEF THERAPEUTICS Holding SA will prevail in any litigation action with NeuroRx over the terms of the Collaboration Agreement, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    SOURCE: Relief Therapeutics Holdings AG



    View source version on accesswire.com:
    https://www.accesswire.com/666219/Relief-Reports-that-US-Collaboration-Partner-Announced-Second-Favorable-Safety-Report-for-ZYESAMITM-RLF-100TMaviptadil-in-NIH-Sponsored-ACTIV-3b-Critical-Care-Study-in-Life-Threatening-COVID-19

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  6. RADNOR, Pa., Sept. 29, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP), a clinical stage, biopharmaceutical company today provided a safety update on ZYESAMI™ (aviptadil) which is being tested in the ACTIV-3b Critical Care Phase 3 study sponsored by the National Institutes of Health. In its second scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns, after reviewing a total of 231 patients, and recommended continued enrollment.

    After Review of 232 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board

    "With this second independent safety analysis in the ACTIV-3b trial, the safety database on ZYESAMI has grown to more than 500 patients across our various clinical trials and expanded access programs. So far, there have been no reports of unexpected, drug-related serious adverse events," said Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NRx.

    ACTIV-3b is a randomized, placebo-controlled trial testing ZYESAMI™ and remdesivir (Veklury) -- alone and in combination -- in hospitalized patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation.

    ACTIV-3b represents one of three ongoing studies of ZYESAMI™ in Severe or Critical COVID-19.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.  

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

    MEDIA CONTACT:

    Jack Hirschfield

    Head of External Affairs, NRx

    jhirschfield@nrxpharma.com 

    512-674-5163                                                

    INVESTOR RELATIONS

    John Mullaly

    LifeSci Advisors

    jmullaly@lifesciadvisors.com

    617-429-3548

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-second-favorable-safety-report-for-zyesami-aviptadil-in-nih-sponsored-activ-3b-critical-care-study-in-patients-with-life-threatening-covid-19-301387353.html

    SOURCE NRx Pharmaceuticals

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  7. GENEVA, SWITZERLAND / ACCESSWIRE / September 28, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) ("NRx"), has issued a press release announcing top line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19 who were treated with ZYESAMI(TM) (RLF-100(TM)/aviptadil). According to NRx's press release, in highly comorbid COVID-19 patients, ZYESAMI(TM) provided a threefold, statistically significant increase in the likelihood of survival at one year, consistent…

    GENEVA, SWITZERLAND / ACCESSWIRE / September 28, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) ("NRx"), has issued a press release announcing top line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19 who were treated with ZYESAMI(TM) (RLF-100(TM)/aviptadil). According to NRx's press release, in highly comorbid COVID-19 patients, ZYESAMI(TM) provided a threefold, statistically significant increase in the likelihood of survival at one year, consistent, according to NRx, with the increased odds of 60-day survival seen in the previously reported results from the phase 2b/3 randomized controlled trial of ZYESAMI(TM) (RLF-100(TM)/aviptadil). The related NRx press release can be accessed through the following link.

    ABOUT RELIEF

    Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100(TM) (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.

    RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.

    CONTACT:
    RELIEF THERAPEUTICS Holding SA
    Jack Weinstein
    Chief Financial Officer and Treasurer
    contact@relieftherapeutics.com

    FOR MEDIA/INVESTOR INQUIRIES:
    Rx Communications Group
    Michael Miller
    +1-917-633-6086
    mmiller@rxir.com

    Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will be determined by regulatory authorities to be safe and effective as a treatment for highly comorbid patients with COVID-19, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 and (iii) those risks discussed in RELIEF THERAPEUTICS Holding AG's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    SOURCE: Relief Therapeutics Holdings AG



    View source version on accesswire.com:
    https://www.accesswire.com/665849/Relief-Reports-that-its-US-Collaboration-Partner-has-Announced-Improved-Survival-at-One-Year-in-Highly-Comorbid-COVID-19-Patients-Treated-with-ZYESAMITM-RLF-100TMaviptadil

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  8. RADNOR, Pa., Sept. 27, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ:NRXP), a clinical stage, biopharmaceutical company, today announced top line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19 who were treated with ZYESAMI™.

    "These latest data are encouraging and will help those of us on the frontlines treat the sickest COVID patients, potentially providing new treatment options and strategies," said Dr. J. Georges Youssef.

    Between June and September 2020, a trial was conducted at a leading tertiary care hospital involving patients with Critical COVID-19 whose level of comorbidity excluded them from the randomized phase 2b/3 clinical trial of ZYESAMI. A statistically significant difference in both survival and recovery from respiratory failure was reported at 28 days. Those findings are soon to be published in a peer-reviewed journal.

    Participants in this trial have now been followed for one year from initial enrollment. Top-line results show a statistically significant (P<.0001) 3-fold advantage in likelihood of being alive at one year post treatment (60% vs. 20%) among those treated with ZYESAMI, in addition to standard of care, compared to those who received the standard of care alone. Assignment to ZYESAMI in the trial was based on the specific medical team which admitted the patient to the intensive care unit (ICU). Once in the ICU, all patients were cared for by the same medical team, and according to the same treatment protocols.

    "We are still learning so much about COVID-19, especially in patients already managing chronic medical conditions, and continuing to recover from COVID-19" said Dr. J. Georges Youssef, the Principal Investigator who serves as Head of Academic Pulmonary Medicine at Houston Methodist Hospital and as Assistant Professor of Clinical Medicine at Weill Cornell Medical College.  "These latest data are encouraging and will help those of us on the frontlines treat the sickest COVID patients, potentially providing new treatment options and strategies." 

    These one-year findings are consistent with the increased odds of 60-day survival seen in the previously reported results from the phase 2b/3 randomized controlled trial of ZYESAMI.  ZYESAMI Remains Under Review by the US Food and Drug Administration for Emergency Use Authorization in Patients Suffering Critical Covid-19 with Respiratory Failure.

    About ZYESAMI™ (aviptadil)/VIP in COVID-19

    ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP). Aviptadil binds specifically to the alveolar type II cell (AT2) in the air sac (alveolus) of the lung, where it has demonstrated potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury and inflammation. Aviptadil stimulates AT2 cells to produce the surfactant that coats the lining of the lungs to facilitate oxygen exchange with blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.

    COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The AT2 cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the AT2 cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). Aviptadil is shown to upregulate surfactant production, block Coronavirus replication in the AT2 cell, block cytokine synthesis, and prevent viral-induced cell death (cytopathy). Other than ZYESAMI™, no currently proposed treatments for COVID-19 specifically target this mechanism of action.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (www.nrxpharma.com) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing Phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority, a part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. NRx also has the BriLife™ vaccine for COVID-19 in clinical trials and holds the exclusive worldwide license to commercialize the vaccine. The BriLife vaccine was first developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.   

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    MEDIA CONTACT                       

    INVESTOR RELATIONS





    Jack Hirschfield                                         

    John Mullaly

    Head of External Affairs, NRx                    

    LifeSci Advisors

    jhirschfield@nrxpharma.com                      

    jmullaly@lifesciadvisors.com

    512-674-5163                                              

    617-429-3548

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-improved-survival-at-one-year-in-highly-comorbid-covid-19-patients-treated-with-zyesami-aviptadil-301385474.html

    SOURCE NRx Pharmaceuticals

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  9. IQVIA™ (NYSE:IQV), a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, today announced a transformative collaboration with NRx Pharmaceuticals (NRx) (NASDAQ:NRXP). NRx is a company dedicated to creating innovative, life-saving treatments and bringing hope to those facing life-altering conditions with no approved disease-modifying therapies or cures. IQVIA is excited to collaborate with NRx as its designated partner, to provide pharmacovigilance services and medical information in preparation for potential regulatory actions.

    "As the world suffers yet another surge of COVID-19, thousands of patients require intensive care and too many succumb to this virus. New…

    IQVIA™ (NYSE:IQV), a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, today announced a transformative collaboration with NRx Pharmaceuticals (NRx) (NASDAQ:NRXP). NRx is a company dedicated to creating innovative, life-saving treatments and bringing hope to those facing life-altering conditions with no approved disease-modifying therapies or cures. IQVIA is excited to collaborate with NRx as its designated partner, to provide pharmacovigilance services and medical information in preparation for potential regulatory actions.

    "As the world suffers yet another surge of COVID-19, thousands of patients require intensive care and too many succumb to this virus. New medicines with new mechanisms of action are urgently needed," said Robert Besthof, chief commercial officer and head of Operations of NRx. "As a small biopharma company preparing to launch a lifesaving medicine across multiple countries, we deeply appreciate the global reach that IQVIA is able to offer in support of patients, families, and those who care for them."

    This collaboration will allow NRx to access IQVIA's domain experience with COVID-19, our unparalleled data assets, and analytics to support potential emergency use authorization (EUA) of ZYESAMI. IQVIA will work closely with NRx to support key activities required for EUA activation, including the pharmacovigilance and medical information programs.

    "We are honored by the opportunity to join with NRx on the EUA activation and compliance for ZYESAMI in treating some of the sickest patients suffering from COVID-19," said Susan Kitlas, vice president, Precommercial Business Unit, IQVIA. "IQVIA's experience and expertise within the COVID-19 market will be a valuable component in helping make this treatment more widely available."

    About NRx

    NRx Pharmaceuticals (NASDAQ-GS:NRXP) draws upon more than 300 combined years of scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense.

    About IQVIA

    IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 74,000 employees, IQVIA conducts operations in more than 100 countries.

    IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA's insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

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  10. RADNOR, Pa., Sept. 8, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP) today announced that NRx's management team will present and host one-on-one investor meetings at the upcoming H.C. Wainwright Global Investment Conference September 13-15, 2021.







    Conference:



    H.C. Wainwright 23rd Annual Global Investment Conference

    Format:



    Virtual on demand presentation and one-on-one meetings

    Presentation:



    Available on demand beginning September 13, 2021 at 7 AM EST

    Webcast:



    https://journey.ct.events/view/c13bb8f5-55cc-4e65-abc5-cf3775cf677d







    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) (www.nrxpharma.com) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing Phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority, a part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. NRx also has the BriLife™ vaccine for COVID-19 in clinical trials and holds the exclusive worldwide license to commercialize the vaccine. The BriLife vaccine was first developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    CORPORATE CONTACT

    Jack Hirschfield

    Head of External Affairs, NRx

    jhirschfield@nrxpharma.com

    512-674-5163                          

    INVESTOR RELATIONS

    John Mullaly

    LifeSci Advisors

    jmullaly@lifesciadvisors.com

    617-429-3548

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-to-participate-in-hc-wainwright-23rd-annual-global-investment-conference-301370874.html

    SOURCE NRx Pharmaceuticals

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  11. GENEVA, SWITZERLAND / ACCESSWIRE / August 31, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) (" NRx "), has issued a press release announcing an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI(TM) (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. According to the press release, the new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function…

    GENEVA, SWITZERLAND / ACCESSWIRE / August 31, 2021 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) (" NRx "), has issued a press release announcing an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI(TM) (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. According to the press release, the new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. This latest analysis also appears to support NRx's plan to submit an application for Breakthrough Therapy Designation to the U.S. Food and Drug Administration for this indication. Relief believes that, if granted, this could confer Priority Review to the aviptadil New Drug Application, when submitted. The related NRx press release can be accessed through the following link .

    ABOUT RELIEF

    Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100 TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,

    in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring to Relief a diverse pipeline of marketed and development-stage programs.

    RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com . Follow us on LinkedIn.

    CONTACT:
    RELIEF THERAPEUTICS Holding SA
    Jack Weinstein
    Chief Financial Officer and Treasurer
    contact@relieftherapeutics.com

    FOR MEDIA/INVESTOR INQUIRIES:
    Rx Communications Group
    Michael Miller
    +1-917-633-6086
    mmiller@rxir.com

    Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether Relief can resolve its ongoing dispute with NRx without litigation, (iii) whether aviptadil will ever be approved in the U.S., UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iv) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    SOURCE: Relief Therapeutics Holdings AG



    View source version on accesswire.com:
    https://www.accesswire.com/662147/Relief-Reports-that-US-Collaboration-Partner-has-Announced-a-New-Finding-from-Aviptadil-Phase-2b3-Trial-Demonstrating-Clinically-Significant-Relief-from-Respiratory-Distress-in-Critical-COVID-19

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  12. RADNOR, Pa., Aug. 30, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP) announced an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. Previously announced results have focused on survival and recovery from respiratory failure at 60 days, and ZYESAMI's apparent role in preventing rise in the inflammatory cytokine IL-6, known as "Cytokine Storm."

    NRx Pharmaceuticals Announces New Finding from ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial

    NRx's new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. The average difference in Respiratory Distress Ratio between those treated with aviptadil and placebo was both clinically meaningful and statistically significant. Moreover, the difference is comparable to that reported a year ago from an open label study at Houston Methodist Hospital by Dr. J Georges Yousef.

    "With the conclusion of the analysis of primary and secondary endpoints, we are able to focus on prespecified endpoints that confirm mechanism of action," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. "COVID-19 attacks the cells that line the lung in a manner that prevents them from transmitting oxygen to the body. It is this respiratory failure that starts the lethal process of COVID," This latest analysis provides confirmatory evidence that aviptadil improves the lung's ability to transmit oxygen within a day of initiating treatment. The benefit was seen across all patients, all baseline severities, and all types of hospitals. We believe this new finding illustrates ZYESAMI's mechanism of action in a placebo-controlled trial and supports our application for Breakthrough Therapy Designation to the FDA."

    Prior data regarding reduced respiratory distress were reported by Dr. J. Georges Youssef, Head of Academic Pulmonary Medicine at Houston Methodist Hospital one year ago. Dr. Youssef and colleagues reported the results in 21 patients treated with ZYESAMI, compared to 24 patients who received best-available standard of care.

    This latest analysis also supports NRx's application for Breakthrough Therapy Designation (BTD) to the FDA for ZYESAMI. BTD is a process designed to expedite the development and review of medicines intended to treat a serious condition and is supported by preliminary clinical evidence showing the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint(s). https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy 

    About ZYESAMI™/VIP in COVID-19

    ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) first discovered by the late Prof. Sami Said in 1970, and ZYESAMI™ is named in his honor. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (www.nrxpharma.com) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority, a part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. NRx currently has the BriLife for COVID-19 in phase 3 trials, and holds the exclusive worldwide license to commercialize the vaccine. The BriLife vaccine was first developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.   

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    CORPORATE CONTACT                       

    INVESTOR RELATIONS





    Jack Hirschfield                                         

    John Mullaly

    Head of External Affairs, NRx                    

    LifeSci Advisors

    jhirschfield@nrxpharma.com                      

    jmullaly@lifesciadvisors.com

    512-674-5163                                              

    617-429-3548

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-new-finding-from-zyesami-aviptadil-phase-2b3-clinical-trial-demonstrating-clinically-significant-relief-from-respiratory-distress-in-critical-covid-19-301365091.html

    SOURCE NRx Pharmaceuticals

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  13. RADNOR, Pa., Aug. 26, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP) announced today it has signed an agreement with Cardinal Health to provide third party logistics and distribution of ZYESAMI™ upon the potential Emergency Use Authorization (EUA) approval by the US Food and Drug Administration (FDA). In May, NRx submitted an application for EUA to the FDA for ZYESAMI™ (aviptadil) for patients suffering from Critical COVID-19 with respiratory failure.

    This partnership creates an efficient and highly flexible logistics and distribution model for NRx.

    "This partnership creates an efficient and highly flexible logistics and distribution model for NRx.  Cardinal Health's expertise will enable ZYESAMI to quickly reach patients in the intensive care units, as limiting the time to treatment is crucial," said Robert Besthof, Head of Operations and Chief Commercial Officer of NRx.  "This also allows NRx to continue focusing on answering requests from the FDA in support of our application for Emergency Use Authorization for ZYESAMI."

    Cardinal Health Specialty Pharmaceutical Distribution will serve as the exclusive distributor for ZYESAMI, providing broad access to hospitals for this needed medicine upon FDA authorization. With one of the largest healthcare supply chains, Cardinal Health services more than 90% of hospitals in the U.S., and has more than 20 years of experience supporting rapid delivery of lifesaving medicines.

    Additionally, Cardinal Health's Third-Party Logistics Services (3PL) will support the warehousing and distribution, full order to cash, and necessary title model services.

    "As the COVID-19 pandemic continues, so does the need for more innovative, effective and FDA-approved therapies for critically-ill patients with respiratory failure," said Marc DeLorenzo, Senior Vice President of Strategic Sourcing at Cardinal Health. "Cardinal Health is pleased to ensure that COVID-19 patients get access to treatment in a timely and efficient manner."

    About ZYESAMI™

    ZYESAMI™ (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) first discovered by the late Prof. Sami Said in 1970, and ZYESAMI™ is named in his honor. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood.  Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.  

    COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the ATII cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). VIP is shown to upregulate surfactant production, block Coronavirus replication in the ATII cell, block cytokine synthesis, and prevent viral-induced cell death (cytopathy). Other than ZYESAMI™, no currently proposed treatments for COVID-19 specifically target this mechanism of action. 

    About NRx Pharmaceuticals 

    NRx Pharmaceuticals (NASDAQ:NRXP) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, NRx was awarded an exclusive worldwide license to develop and commercialize the BriLife (VSV-ΔG) COVID-19 vaccine developed by the Israel Institute of Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    About Cardinal Health 

    Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 35 countries and approximately 44,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.

    Cautionary Note Regarding Forward-Looking Statements 

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.    

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise.    Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.  

    CORPORATE CONTACT             

    INVESTOR RELATIONS





    Jack Hirschfield                     

    John Mullay

    Head of External Affairs, NRx 

    Lifesci Advisors

    jhirschfield@nrxpharma.com    

    jmllaly@lifescienceadvisors.com

    512-674-5163                            

    617-429-3548

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-to-work-with-cardinal-health-to-ensure-efficient-distribution-of-potential-therapies-301363293.html

    SOURCE NRx Pharmaceuticals

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  14. RADNOR, Pa., Aug. 24, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ:NRXP), today announced that it has completed its previously announced private placement for the purchase of 2,727,273 shares of common stock. The Company issued to the investors in the private placement unregistered preferred investment options (the "investment options") to purchase up to an aggregate of 2,727,273 shares of common stock. The purchase price for one share of common stock and one investment option to purchase one share of common stock was $11.00. The investment options have an exercise price of $12.00 per share, are immediately exercisable, and have a term equal to three years following the date of issuance.

    RADNOR, Pa., Aug. 24, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ:NRXP), today announced that it has completed its previously announced private placement for the purchase of 2,727,273 shares of common stock. The Company issued to the investors in the private placement unregistered preferred investment options (the "investment options") to purchase up to an aggregate of 2,727,273 shares of common stock. The purchase price for one share of common stock and one investment option to purchase one share of common stock was $11.00. The investment options have an exercise price of $12.00 per share, are immediately exercisable, and have a term equal to three years following the date of issuance.

    NRx Pharmaceuticals Announces Closing of $30 Million Private Placement

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The gross proceeds from the private placement were $30 million before deducting placement agent fees and other offering expenses.

    "This investment provides critical resources to advance three late-stage assets that include a Fast Track medicine for the sickest of COVID-19 patients, a vaccine that targets COVID-19 and its lethal variants, together with a Fast Track / Breakthrough Therapy for suicidal bipolar depression and PTSD," said Prof. Jonathan Javitt, MD, MPH Chairman and CEO of NRx. "We appreciate the support of these visionary institutional investors for our mission of bringing lifesaving therapies to those in need."

    The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.  

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

    CORPORATE CONTACT

    INVESTOR RELATIONS





    Jack Hirschfield

    John Mullaly

    Head of External Affairs, NRx

    LifeSci Advisors

    jhirschfield@nrxpharma.com 

    jmullaly@lifesciadvisors.com

    512-674-5163

    617-429-3548

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-closing-of-30-million-private-placement-301361443.html

    SOURCE NRx Pharmaceuticals

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  15. RADNOR, Pa., Aug. 23, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (Nasdaq: NRXP), a clinical stage, biopharmaceutical company noted today reports1 in the Israeli media that participants in the BriLife vaccine trial who received the highest dose vaccine were notified by local health authorities they did not need a third, booster dose of the vaccine as their protection remained high, six months after getting a second dose. Trial surveillance continues and this guidance may change in the future. 

    Participants in High Dose BriLife™ Investigational Vaccine Trial for COVID-19 Advised Booster Not Necessary

    Media reported 230 volunteers who received the highest dosage of the vaccine, developed by the Israel Institute for Biological Research were notified that they did not need a third dose of the vaccine as their protection remained high, six months after getting a second dose.

    Participants who received lower doses of the BriLife vaccine have been advised to get a booster vaccination with Pfizer or Moderna shots, as those lower dosages do not appear to offer sufficient long-term protection.

    "These reports, based on medical determinations made at local level suggest potential performance of the BriLife vaccine at a time when ICUs around the world are racing to capacity," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx. "With this new information, and more expected in the coming weeks, we are preparing to submit a phase 2b/3 protocol for BriLife against an established active comparator." 

    The BriLife vaccine differs from other COVID-19 vaccines by presenting the entire COVID-19 spike protein to the body's immune system. It also differs from other COVID-19 vaccine approaches in that it is a self-propagating, live-virus vaccine in which the spike protein of the vaccine appears to evolve in a manner consistent with the evolution of the SARS-CoV-2 virus in nature. Thus, while variants may arise that support manual enrichment of the vaccine against those specific variants, the vaccine itself may continue to evolve in a manner that provides ongoing protection against variants.

    The BriLife™ vaccine (technical name VSV ΔG22) is based on a previous, FDA-approved vaccine platform that was further optimized by the Israel Institute for Biological Research targeted towards COVID-19.

    NRx has signed a Memorandum of Understanding with the Israel Ministry of Defense under which NRx has exclusive worldwide rights to develop and market the BriLife vaccine in exchange for customary royalty and milestone payments.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.   

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    CORPORATE CONTACT: 

    Jack Hirschfield

    Head of External Affairs, NRx 

    jhirschfield@nrxpharma.com  

    512-674-5163                                                

    INVESTOR RELATIONS

    John Mullaly

    LifeSci Advisors

    jmullaly@lifesciadvisors.com 

    617-429-3548

    1 https://www.timesofisrael.com/tv-high-dose-of-israeli-made-vaccine-appears-to-give-long-lasting-protection/?

    2 VSV Delta G

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/participants-in-high-dose-brilife-investigational-vaccine-trial-for-covid-19-advised-booster-not-necessary-301360593.html

    SOURCE NRx Pharmaceuticals

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  16. RADNOR, Pa., Aug. 19, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP) (or the "Company"), a Delaware corporation, today announced that it has entered into definitive agreements with investors to purchase 2,727,273 shares of common stock in a private placement. The Company will also issue to the investors unregistered preferred investment options (the "investment options") to purchase up to an aggregate of 2,727,273 shares of common stock. The purchase price for one share of common stock and one investment option to purchase one share of common stock is $11.00.  The investment options have an exercise price of $12.00 per share, will be immediately exercisable, and will have a term equal to three years following the date of issuance…

    RADNOR, Pa., Aug. 19, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP) (or the "Company"), a Delaware corporation, today announced that it has entered into definitive agreements with investors to purchase 2,727,273 shares of common stock in a private placement. The Company will also issue to the investors unregistered preferred investment options (the "investment options") to purchase up to an aggregate of 2,727,273 shares of common stock. The purchase price for one share of common stock and one investment option to purchase one share of common stock is $11.00.  The investment options have an exercise price of $12.00 per share, will be immediately exercisable, and will have a term equal to three years following the date of issuance.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds from the private placement are expected to be approximately $30 million before deducting placement agent fees and other offering expenses. The private placement is expected to close on or about August 23, 2021, subject to the satisfaction of customary closing conditions.

    "The proceeds of this investment will be targeted towards accelerating the forward path of our CNS/psychiatry franchise and COVID vaccine franchises, together with supporting the transition of ZYESAMI from clinical to commercial stage as regulatory approval is obtained from national regulators," said Jonathan C. Javitt, MD, MPH, CEO and Chairman of NRx Pharmaceuticals.

    The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management. The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise.  Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

    CORPORATE CONTACT

    INVESTOR RELATIONS





    Jack Hirschfield

    John Mullaly

    Head of External Affairs, NRx

    LifeSci Advisors

    jhirschfield@nrxpharma.com 

    jmullaly@lifesciadvisors.com

    512-674-5163

    617-429-3548

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-30-million-private-placement-301358995.html

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  17. GENEVA, SWITZERLAND / ACCESSWIRE / August 19, 2021 / RELIEF THERAPEUTICS Holding SA ((SIX: RLF, OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) (" NRx ") provided a safety update on ZYESAMI(TM) (aviptadil) which is being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health (NIH). The related NRx press release can be accessed through the following link .

    ABOUT RELIEF

    Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients…

    GENEVA, SWITZERLAND / ACCESSWIRE / August 19, 2021 / RELIEF THERAPEUTICS Holding SA ((SIX: RLF, OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) (" NRx ") provided a safety update on ZYESAMI(TM) (aviptadil) which is being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health (NIH). The related NRx press release can be accessed through the following link .

    ABOUT RELIEF

    Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100 TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy,

    in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.

    RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com . Follow us on LinkedIn.

    CONTACT:
    RELIEF THERAPEUTICS Holding SA
    Jack Weinstein
    Chief Financial Officer and Treasurer
    contact@relieftherapeutics.com

    FOR MEDIA/INVESTOR INQUIRIES:
    Rx Communications Group
    Michael Miller
    +1-917-633-6086
    mmiller@rxir.com

    Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether NeuroRx will provide Relief with the data from its Phase 2b/3 study, (ii) whether aviptadil will ever be approved in the UK or the EU for the treatment of respiratory failure in critically ill patients with COVID-19, and (iii) those risks discussed in Relief's filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    SOURCE: Relief Therapeutics Holdings AG



    View source version on accesswire.com:
    https://www.accesswire.com/660462/Relief-Reports-that-its-US-Collaboration-Partner-has-Announced-a-Positive-Safety-Report-for-ZYESAMITM-aviptadil-in-NIH-Sponsored-ACTIV-3-Study-in-Patients-with-Life-Threatening-COVID-19

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  18. RADNOR, Pa., Aug. 18, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP), a clinical stage, biopharmaceutical company today provided a safety update on ZYESAMI (aviptadil) which is being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health. The study's Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment.

    After Review of Approximately 140 patients, No New Safety Concerns Raised by Independent Data Safety Monitoring Board

    ACTIV-3 is a randomized, blinded, placebo-controlled clinical trial testing ZYESAMI and the antiviral remdesivir (Veklury) in hospitalized patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen, delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation. 

    Study investigators are randomizing patients to receive one of four treatment regimens in addition to standard of care: both ZYESAMI and remdesivir, ZYESAMI and a placebo, remdesivir and placebo, or only placebo. ZYESAMI is administered as a daily 12 hour intravenous infusion over three days. Those randomized to receive remdesivir will receive it for up to 10 days via intravenous infusion.

    ZYESAMI (aviptadil) is a proprietary, synthetic version of Vasoactive Intestinal Peptide or VIP, which is made naturally in the human body and appears to have lung-protective, anti-viral and anti-inflammatory effects.

    ACTIV-3 represents one of three ongoing studies of ZYESAMI in Severe or Critical COVID-19.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.   

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    CORPORATE CONTACT: 

    Jack Hirschfield

    Head of External Affairs, NRx 

    jhirschfield@nrxpharma.com  

    512-674-5163                                                 

    INVESTOR RELATIONS

    John Mullaly

    LifeSci Advisors

    jmullaly@lifesciadvisors.com 

    617-429-3548

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-positive-safety-report-for-zyesami-aviptadil-in-nih-sponsored-activ-3-critical-care-study-in-patients-with-life-threatening-covid-19-301358180.html

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  19. RADNOR, Pa., Aug. 16, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP), a clinical stage biopharmaceutical company today provided a business update and financial results for the quarter ended June 30, 2021. NRx will host a conference call Tuesday, August 17, 2021, at 8:30AM Eastern Time to discuss its business update and second quarter financial results. "NRx is pleased to report its first quarterly results as a publicly-traded company. We have continued to make substantial progress as a company with the filing of an EUA request for ZYESAMI in the US on May 31st, and the filing and granting of an EUA in the Nation of Georgia, with first orders expected shortly. We are honored to have been selected by the Israeli Institute for Biological…

    RADNOR, Pa., Aug. 16, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP), a clinical stage biopharmaceutical company today provided a business update and financial results for the quarter ended June 30, 2021. NRx will host a conference call Tuesday, August 17, 2021, at 8:30AM Eastern Time to discuss its business update and second quarter financial results. "NRx is pleased to report its first quarterly results as a publicly-traded company. We have continued to make substantial progress as a company with the filing of an EUA request for ZYESAMI in the US on May 31st, and the filing and granting of an EUA in the Nation of Georgia, with first orders expected shortly. We are honored to have been selected by the Israeli Institute for Biological Research to develop and market the BriLife COVID vaccine. Finally, we are looking forward to restarting trials of our psychiatry drug, NRX-101, in the coming months," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx.

    NRx Pharmaceuticals Announces 2nd Quarter 2021 Financial Update

    Business Highlights in Q2

    Primary clinical activities during the quarter centered around analysis and regulatory filing of data from the phase 2b/3 trial of intravenous ZYESAMI™ for COVID-19 Respiratory Failure, support of the NIH-sponsored ACTIV3b Critical Care study of ZYESAMI compared to Veklury (remdesivir) alone and in combination, support of the BARDA-sponsored I-SPY trial of inhaled ZYESAMI, and the NRx-sponsored trial of inhaled ZYESAMI.

    On the manufacturing front, the Company focused on development of the first shelf-stable formulation of ZYESAMI, which was announced in early Q3, along with engagement in scaling up aviptadil drug substance from 100,000 doses per manufacturing batch to a projected 3 million doses per batch, combined with a 90% reduction in cost per gram of aviptadil drug substance.

    On the business development front, NRx engaged in successful collaborative negotiations with the Israeli Institute for Biological Research (IIBR) that resulted in the long-term partnership announced in Q3. The company entered into a collaborative agreement with TFF Pharmaceuticals to develop a dry powder reconstitutable form of ZYESAMI that has now demonstrated initial room temperature stability. This technology has now shown promise for the development of a dry powder version of the BriLife vaccine. Our enthusiasm for this development project is based on nonclinical data suggesting an effective neutralizing antibody response to the Delta and other COVID variants, together with the rapidity with which this vaccine technology can be modified to cover new variants as they emerge. The company further initiated business development interactions with MannKind Corporation to leverage the Technosphere® platform for future inhaled use of ZYESAMI.

    On a commercial level, the Company finalized its logistics and drug distribution contract with Cardinal Health, Inc., and its drug launch and commercialization support agreement with IQVIA, Inc. During Q2, NRx began its engagement with Georgia, Ukraine, and other countries around Emergency Use of ZYESAMI and potential clinical trials of the BriLife vaccine.

    At a corporate level, much of Q2 was devoted to finalizing the business combination between NeuroRx, Inc. and Big Rock Partners Acquisition Corp (NASDAQ:BRPA) that led to the creation of NRx.

    Second Quarter Financial Results

    NRx reported a net loss of $16.0 million for the three months ended June 30, 2021, compared to a net loss of $0.1 million for the three months ended June 30, 2020. The increase in net loss was primarily related to increases in R&D expenses, G&A expenses (which were primarily non-cash expenses associated with exercise of warrants and restructuring of the Company's Stock Option Plan) and a reduction in reimbursement of expenses from Relief Therapeutics during the second quarter of 2021 versus the prior year. Research and development expenses were $4.7 million during the three months ended June 30, 2021, compared to $1.4 million during the three months ended June 30, 2020. These costs were primarily associated with the completion of the phase 2b/3 trial of ZYESAMI. General and administrative expenses were $12.5 million for the three months ended June 30, 2021, compared to $0.5 million during the three months ended June 30, 2020. This was driven primarily by $5.5 million of consultant fees (of which $4.9 million relates to non-cash consulting fees) and $4.0 million in stock compensation expense (of which $3.3 million relates to modification of stock options and warrants due to the SPAC merger). As of June 30, 2021, cash and cash equivalents were $13.4 million, compared to $1.9 million as of December 31, 2020. In addition, NRx received $9.2 million subsequent to June 30, 2021 from the exercise of warrants. 

    As stated in the 10-Q filing, NRx has sufficient core operating funds to support operations through the next 12 months. Clinical trial operations for ACTIV3b and I-SPY are primarily funded by the US Government. We anticipate that the BriLife vaccine development program will be co-funded by a commercial partner with additional partnerships in development.

    Conference Call and Webcast Information

    NRx will host a conference call and webcast on August 17, 2021 8:30 AM Eastern Time to discuss its results and provide a clinical and corporate update. Management will host the call, followed by a question-and-answer period. Analysts and investors interested in submitting questions must do so in advance of the call,and are encouraged to email questions to the Company's investor relations representative at jmullaly@lifesciadvisors.com.

    Investors and the general public are invited to listen to a live audio webcast of the conference call, which may be accessed five minutes prior to the start of the call by dialing (877) 705-6003 (U.S.), (201) 493-6725 (International) Conference ID: 13722418, or through the webcast link http://public.viavid.com/index.php?id=146267. A replay will be available from the NRx Pharmaceuticals website following the call at www.nrxpharma.com.

    NRX PHARMACEUTICALS, INC.



    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS



    (Unaudited)































    Three months ended



    Six months ended





    June 30, 



    June 30, 





    2021



    2020



    2021



    2020

    Operating expenses:

























    Research and development



    $

    4,659,280



    $

    1,390,376



    $

    7,567,984



    $

    1,994,709

    General and administrative





    12,457,534





    525,736





    14,558,936





    1,141,390

    Settlement expense













    21,365,641





    Reimbursement of expenses from Relief Therapeutics









    (2,020,931)





    (771,244)





    (2,020,931)

    Total operating expenses





    17,116,814





    (104,819)





    42,721,317





    1,115,168

    Income (loss) from operations





    (17,116,814)





    104,819





    (42,721,317)





    (1,115,168)

    Other (income) expenses:

























    Gain on extinguishment of debt













    (120,810)





    Interest expense





    5,107





    2,532





    10,288





    38,800

    Change in fair value of warrant liability





    (1,468,649)









    (1,468,649)





    Change in fair value of Earnout Cash liability





    354,701









    354,701





    Change in fair value of embedded put

















    27,160

    Loss on conversion of convertible notes payable

















    306,641

    Total other (income) expenses





    (1,108,841)





    2,532





    (1,224,470)





    372,601

    Income (loss) before tax





    (16,007,973)





    102,287





    (41,496,847)





    (1,487,769)

    Provision for income taxes

















    Net income (loss)





    (16,007,973)





    102,287





    (41,496,847)





    (1,487,769)

    Deemed dividend - modification of warrants





    (2,691,799)









    (2,691,799)





    Deemed dividend - Earnout Shares





    (253,130,272)









    (253,130,272)





    Net income (loss) attributable to common stockholders



    $

    (271,830,043)



    $

    102,287



    $

    (297,318,917)



    $

    (1,487,769)

    Net earnings (loss) per share:

























    Basic



    $

    (0.38)



    $



    $

    (1.07)



    $

    (0.04)

    Diluted



    $

    (0.38)



    $



    $

    (1.07)



    $

    (0.04)

    Net earnings (loss) per share attributable to common stockholders:

























    Basic



    $

    (6.51)



    $



    $

    (7.68)



    $

    (0.04)

    Diluted



    $

    (6.51)



    $



    $

    (7.68)



    $

    (0.04)

    Weighted average common shares outstanding:

























    Basic





    41,727,480





    33,819,205





    38,709,614





    33,799,503

    Diluted





    41,727,480





    36,656,420





    38,709,614





    33,799,503

     

    NRX PHARMACEUTICALS, INC.



    CONDENSED CONSOLIDATED BALANCE SHEETS







    June 30, 2021



    December 31, 2020





    (Unaudited)







    ASSETS













    Current assets:













    Cash



    $

    13,386,332



    $

    1,858,513

    Account receivable, net of allowance of $5,470,897 and $257,463 as

       of June 30, 2021 and December 31, 2020, respectively









    831,390

    Prepaid expenses and other current assets





    5,147,650





    240,352

    Total current assets





    18,533,982





    2,930,255

    Other assets





    12,730





    10,914

    Total assets



    $

    18,546,712



    $

    2,941,169

    LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)













    Current liabilities:













    Accounts payable (includes $44,201 and $149,067 due to related

       parties)



    $

    6,268,319



    $

    3,153,310

    Accrued and other current liabilities





    1,506,337





    1,728,483

    Accrued clinical site costs





    1,133,312





    1,547,432

    Earnout Cash liability





    25,874,896





    Warrant liabilities





    515,025





    Notes payable and accrued interest





    173,694





    248,861

    Accrued settlement expense









    39,486,139

    Total current liabilities





    35,471,583





    46,164,225

    Notes payable and accrued interest





    512,472





    547,827

    Total liabilities



    $

    35,984,055



    $

    46,712,052

    Stockholders' equity (deficit):













    Preferred stock, $0.001 par value, 50,000,000 shares authorized; 0

       shares issued and outstanding at June 30, 2021 and December 31, 

       2020, respectively









    Common stock, $0.001 par value, 500,000,000 shares authorized; 

       48,603,585 and 42,973,462 shares issued and outstanding at June 30, 

       2021 and December 31, 2020, respectively





    48,604





    42,974

    Additional paid-in capital





    114,190,620





    46,365,863

    Accumulated deficit





    (131,676,567)





    (90,179,720)

    Total stockholders' equity (deficit)





    (17,437,343)





    (43,770,883)

    Total liabilities and stockholders' equity



    $

    18,546,712



    $

    2,941,169

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (www.nrxpharma.com) (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.   

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise.  Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    CORPORATE CONTACT



    INVESTOR RELATIONS







    Jack Hirschfield



    John Mullaly

    Head of External Affairs, NRx



    LifeSci Advisors

    jhirschfield@nrxpharma.com



    jmullaly@lifesciadvisors.com

    512-674-5163



    617-429-3548

     

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  20. --Company to Host Conference Call August 17, 2021 at 8:30AM ET--

    RADNOR, Pa., Aug. 11, 2021 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP), a clinical stage, global biopharmaceutical company, today announced that management will report second quarter 2021 financial results after the market close on August 16, 2021. The company will host a conference call and webcast on August 17, 2021, 8:30 AM Eastern Time to discuss its results and provide a clinical and corporate update. Management will host the call, followed by a question-and-answer period. Analysts and investors interested in submitting questions must do so in advance of the call and are encouraged to email questions to the Company's investor relations representative at…

    --Company to Host Conference Call August 17, 2021 at 8:30AM ET--

    RADNOR, Pa., Aug. 11, 2021 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP), a clinical stage, global biopharmaceutical company, today announced that management will report second quarter 2021 financial results after the market close on August 16, 2021. The company will host a conference call and webcast on August 17, 2021, 8:30 AM Eastern Time to discuss its results and provide a clinical and corporate update. Management will host the call, followed by a question-and-answer period. Analysts and investors interested in submitting questions must do so in advance of the call and are encouraged to email questions to the Company's investor relations representative at jmullaly@lifesciadvisors.com.

    Investors and the general public are invited to listen to a live audio webcast of the conference call, which may be accessed five minutes prior to the start of the call by dialing (877) 705-6003 (U.S.), (201) 493-6725 (International) Conference ID: 13722418, or through the webcast link http://public.viavid.com/index.php?id=146267. A replay will be available from the NRx Pharmaceuticals website following the call at www.nrxpharma.com.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (www.nrxpharma.com) (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track Designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

    CORPORATE CONTACT:

    Jack Hirschfield - Head of External Affairs, NRx

    jhirschfield@nrxpharma.com

    INVESTOR RELATIONS

    John Mullaly

    Managing Director - LifeSci Advisors

    jmullaly@lifesciadvisors.com



    Primary Logo

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  21. RADNOR, Pa., Aug. 10, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP), a clinical stage, global biopharmaceutical company today announced that the NRx Team, together with Prof Jonathan Javitt, Founder, Chairman and CEO of NRx, will ring the Nasdaq Closing Bell on Tuesday, August 10, 2021 in celebration of NRx's listing on the Nasdaq Exchange. The ceremony will begin at approximately 3:45 PM ET and can be viewed live at https://www.nasdaq.com/marketsite/bell-ringing-ceremony.

    NRx Pharmaceuticals to Ring Nasdaq Closing Bell on August 10, 2021

    "As we celebrate our first grant of Emergency Use of ZYESAMI™ for COVID-19 overseas and as we initiate international trials for a novel COVID-19 vaccine, we are honored to ring the Nasdaq closing bell," said Prof Jonathan Javitt, MD, MPH Chairman and CEO of NRx. "Our team has gathered from around the nation to support our credo "Bringing Hope to Life." As the pandemic continues to devastate families and communities around the world, we strive to advance therapies that aim to get patients with COVID-19 back home to their families and to develop a uniquely promising vaccine that may yield improved immunity against the variants that challenge our way of life."

    The US Food and Drug Administration (FDA) granted Fast Track Designation to NRx for Intravenous ZYESAMI™ (aviptadil) for the treatment of Critical COVID-19 with respiratory failure. NRx has submitted data from a Phase 2b/3 trial of intravenous ZYESAMI™ to the FDA in support of Emergency Use Authorization in the U.S. Ongoing trials, sponsored by the US National Institutes of Health aim to compare ZYESAMI to Veklury from Gilead Sciences (NASDAQ:GILD). 

    NRx has also been granted exclusive worldwide development and marketing rights to the BriLife™COVIDvaccine developed by the Israel Institute for Biological Research (IIBR). Yesterday, NRx and the Government of Israel announced initiation of phase 2b/3 clinical trials in the Caucasus region in partnership with the Senator Richard Lugar Institute for Biological Research.

    In addition to COVID and respiratory focused therapies and vaccines, NRx remains focused on its patented drug, NRX-101 for Suicidal Depression and PTSD. The FDA has awarded Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022.

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (www.nrxpharma.com) (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.   

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise.  Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    CORPORATE CONTACT

    INVESTOR RELATIONS

    Jack Hirschfield

    John Mullaly

    Head of External Affairs, NRx

    LifeSci Advisors

    jhirschfield@nrxpharma.com

    jmullaly@lifesciadvisors.com

    512-674-5163

    617-429-3548

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-to-ring-nasdaq-closing-bell-on-august-10-2021-301351683.html

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  22. RADNOR, Pa., Aug. 9, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP), a clinical stage, global biopharmaceutical company today announced it is initiating a phase 2b dose-confirmatory trial of the BriLife™ vaccine against COVID-19 in the Nation of Georgia.  The vaccine is developed by the Israel Institute for Biological Research (IIBR).  The trial is being conducted with oversight from the Senator Richard Lugar Center for Public Health Research. The purpose of the study is to confirm the vaccine's ability to generate an immune response against the COVID-19 Delta variant, prior to entering phase 3 trials in multiple nations. The phase 2b program will also incorporate a potential intradermal vaccination option where a small quantity…

    RADNOR, Pa., Aug. 9, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP), a clinical stage, global biopharmaceutical company today announced it is initiating a phase 2b dose-confirmatory trial of the BriLife™ vaccine against COVID-19 in the Nation of Georgia.  The vaccine is developed by the Israel Institute for Biological Research (IIBR).  The trial is being conducted with oversight from the Senator Richard Lugar Center for Public Health Research. The purpose of the study is to confirm the vaccine's ability to generate an immune response against the COVID-19 Delta variant, prior to entering phase 3 trials in multiple nations. The phase 2b program will also incorporate a potential intradermal vaccination option where a small quantity of vaccine is placed into the skin instead of a traditional needle injection into a muscle.

    NRx Pharmaceuticals Announces Initiation of Phase 2b Trial of BriLife™ Vaccine for Covid-19 in Nation of Georgia

    The vaccine differs from other COVID-19 vaccines by presenting the entire COVID-19 spike protein to the body's immune system. The spike protein complex from variants may be added to the BriLife vaccine as new variants are discovered.

    The BriLife™ vaccine also differs from other COVID-19 vaccine approaches in that it is a self-propagating, live-virus vaccine that may be updated to address new variants of COVID-19 more rapidly than some other vaccine platforms. The clinical trials in Georgia will take place at the same time as the completion of the second phase of clinical trials in Israel. NRx is recruiting volunteers, and expanding the second phase of clinical trials abroad, in order to increase the statistical sample and prepare the regulatory file necessary for further trials.

    A spokesperson for Israel's Minister of Defense stated today that, "IIBR will accompany the process and will continue to provide scientific knowledge in order to complete the trials."

    "We at NRx are honored to have been selected for this project and grateful for the trust placed in us by the Government of Israel, the people of Georgia, and its neighboring countries," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx. "As the Delta and subsequent variants continue to threaten the immunity generated by first-generation vaccines, we hope that this new vector-based approach may offer enhanced immunity."

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (www.nrxpharma.com) (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.   

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise.  Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    CORPORATE CONTACT





     INVESTOR RELATIONS

    John Mullaly

    Jack Hirschfield

    Head of External Affairs, NRx

    LifeSci Advisors

    jhirschfield@nrxpharma.com

    jmullaly@lifesciadvisors.com

    512-674-5163 

    617-429-3548

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-initiation-of-phase-2b-trial-of-brilife-vaccine-for-covid-19-in-nation-of-georgia-301351289.html

    SOURCE NRx Pharmaceuticals

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  23. RADNOR, Pa., Aug. 4, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP) announced today it has signed an agreement with MannKind Corporation to develop a dry powder formulation of ZYESAMI (aviptadil), a synthetic form of human Vasoactive Intestinal Peptide (VIP), produced by the body to help protect cells against inflammatory conditions. Development will be based on MannKind's proven Technosphere® platform, that is the basis of the US Food and Drug Administration (FDA) -approved Afrezza® inhaled insulin product.

    NRx Pharmaceuticals Partners with MannKind Corporation to Further Develop Inhalable Formulation of ZYESAMI™

    In June 2020, FDA awarded a Fast Track Designation to NRx for the use of aviptadil for the treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome associated with COVID-19. The investigational drug has demonstrated a greater than 2-fold increased odds of survival at 60 days in a phase 2b/3 clinical trial, and demonstrated significantly reduced IL-6 cytokine formation (commonly known as cytokine storm) compared to placebo. Both intravenous and inhaled formulations of ZYESAMI™ are in phase 3 clinical trials funded by the US National Institutes of Health, the Biomedical Advanced Research Development Authority (BARDA), and by NRx.

    Although Vasoactive Intestinal Peptide (VIP) was discovered in 1970, NRx was the first to formulate aviptadil (the synthetic form of VIP) for  human intravenous and inhaled use under the "Good Manufacturing Practices" (GMP) standards required by FDA and other regulators in 2020. The stable, sterile liquid formulation of ZYESAMI™ developed by NRx is suitable for emergency use and stockpiling purposes. With clinical effects of aviptadil now emerging in clinical trials, NRx is broadening its focus to develop a simple, room-temperature inhaled delivery system that is convenient for patients and is already proven in commercial manufacture. Senior FDA officials and others have emphasized the need to develop inhaled drugs to treat COVID and other acute lung disorders in order to increase patient convenience and move treatment from the ICU to the outpatient setting.

    "As we continue to identify the beneficial effects of VIP in treating various respiratory disorders, development of a convenient dosing method that offers multi-year stability at room temperature is key to meeting the needs of patients." said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx (see concept image). "I had the privilege of working closely with Dr. Alfred Mann, on the refinement and regulatory approval of MannKind's Technosphere platform and have long admired its simplicity and elegance. On many occasions he and I discussed his vision to extend Technosphere beyond insulin to solve the unique stability and administration challenges of peptide-based drugs. I am personally delighted to be partnering once again with MannKind and bringing Dr. Mann's vision to life."  

    "We are looking forward to the collaboration with NRx and looking for an avenue to marry the benefits of our Technosphere technology with ZYESAMI," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Our focus is to continue to explore ways that our Technosphere technology can deliver unique compounds in a targeted and convenient manner for patients with serious lung diseases."

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NASDAQ:NRXP) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, NRx was awarded an exclusive worldwide license to develop and commercialize the BriLife (VSV-ΔG) COVID-19 vaccine developed by the Israel Institute of Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits, and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra-rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company's partner, Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing and R&D facility based in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S.  Please visit mannkindcorp.com to learn more.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management. 

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    For MannKind:

    For NRx:

    Christie Iacangelo, Corporate Communications

    Jack Hirschfield, Head of External Affairs

    (818) 292-3500

    (512) 674-5163

    Email: media@mannkindcorp.com 

    Email: jhirschfield@nrxpharma.com





    Rose Alinaya, Investor Relations

    John Mulally, Investor Relations

    (818) 661-5000

    (617) 429-3548

    Email: ir@mannkindcorp.com 

    Email: jmulally@lifesciadvisors.com

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-partners-with-mannkind-corporation-to-develop-zyesami-aviptadil-inhaler-for-respiratory-conditions-301348051.html

    SOURCE NRx Pharmaceuticals

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  24. WESTLAKE VILLAGE, Calif., Aug. 4, 2021 /PRNewswire/ -- MannKind Corporation (NASDAQ:MNKD) has partnered with NRx Pharmaceuticals (NASDAQ:NRXP) (NRx) to evaluate the feasibility of formulating a dry powder formulation of ZYESAMI (aviptadil), a synthetic form of human Vasoactive Intestinal Peptide (VIP) – an endogenous substance produced by the body that helps protect cells against inflammatory conditions.  An intravenous formulation of ZYESAMI is currently in clinical trials, having been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Critical COVID-19 with Respiratory Failure.

    WESTLAKE VILLAGE, Calif., Aug. 4, 2021 /PRNewswire/ -- MannKind Corporation (NASDAQ:MNKD) has partnered with NRx Pharmaceuticals (NASDAQ:NRXP) (NRx) to evaluate the feasibility of formulating a dry powder formulation of ZYESAMI (aviptadil), a synthetic form of human Vasoactive Intestinal Peptide (VIP) – an endogenous substance produced by the body that helps protect cells against inflammatory conditions.  An intravenous formulation of ZYESAMI is currently in clinical trials, having been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Critical COVID-19 with Respiratory Failure.

    "We continue to explore ways that our Technosphere technology can deliver unique compounds in a targeted and convenient manner for patients with serious lung diseases," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "The novel coronavirus continues to be a factor around the world, and we are just beginning to bear witness to its long-term effects on the lungs."

    Rapid recovery from Critical COVID-19 with Respiratory Failure has been reported in patients treated with open label VIP under a Phase 2b/3 clinical trial and in an FDA Expanded Access Program. Emerging data indicates that VIP binds uniquely to receptors on Alveolar Type II cells preventing cell death, stopping replication of the coronavirus in the Type II cells and upregulating the production of surfactant – the loss of which is increasingly implicated in COVID-19 respiratory failure.

    "As we continue to identify beneficial effects of VIP in treating various respiratory disorders, development of a convenient dosing method that offers stability at room temperature is key to long term success," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of the Board, of NRx. "We are pleased to be working with MannKind to develop an inhaled form of ZYESAMI which may offer patients an easier and more therapeutic option."

    MannKind will begin exploring formulation potential at its research and manufacturing facility located in Danbury, Conn., which features a full range of development and manufacturing capabilities, including analytical, chemical, formulation, filling and packaging. It has sufficient filling capacity to produce more than 300 million cartridges of inhaled drug annually.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra-rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company's partner, Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing and R&D facility based in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S.  Please visit mannkindcorp.com to learn more.

    Forward-looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "plans," "expects," "intend," "will," "targeted," "potential" and similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding the potential to create a dry powder formulation of a new compound and to treat certain diseases. Such forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that continued testing of product candidates may not yield successful results.  These and other risks are detailed in MannKind's filings with the Securities and Exchange Commission ("SEC"), including under the heading "Risk Factors" in MannKind's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 12, 2021. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    ZYESAMI is a trademark of NRx Pharmaceuticals, Inc.

    AFREZZA and TECHNOSPHERE are registered trademarks of MannKind Corporation.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/mannkind-partners-with-nrx-pharmaceuticals-to-explore-a-dry-powder-formulation-of-zyesami-aviptadil-based-on-the-technosphere-platform-301347875.html

    SOURCE MannKind Corporation

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  25. GENEVA, SWITZERLAND / ACCESSWIRE / July 28, 2021 / RELIEF THERAPEUTICS Holding AG ((SIX: RLF, OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) (" NRx ") reported in a press release yesterday that the Nation of Georgia's Prime Minister and Minister of Health have issued an Emergency Use Authorization for intravenous aviptadil for the treatment of critical COVID-19.

    NRx also reported that the first doses of aviptadil will arrive in the Nation of Georgia within 24 hours, and discussions are underway with the Ministry of Health to provide access…

    GENEVA, SWITZERLAND / ACCESSWIRE / July 28, 2021 / RELIEF THERAPEUTICS Holding AG ((SIX: RLF, OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc., (NASDAQ:NRXP) (" NRx ") reported in a press release yesterday that the Nation of Georgia's Prime Minister and Minister of Health have issued an Emergency Use Authorization for intravenous aviptadil for the treatment of critical COVID-19.

    NRx also reported that the first doses of aviptadil will arrive in the Nation of Georgia within 24 hours, and discussions are underway with the Ministry of Health to provide access to ZYESAMI(TM) to Georgians suffering with Critical COVID-19.

    The related NRx press release can be accessed through the following link .

    ###

    ABOUT RELIEF

    Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100 TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisition of APR Applied Pharma Research brings a diverse pipeline of marketed and development-stage programs.

    RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com . Follow us on LinkedIn.

    CONTACT:
    RELIEF THERAPEUTICS Holding AG
    Jack Weinstein
    Chief Financial Officer and Treasurer
    Mail: contact@relieftherapeutics.com

    FOR MEDIA/INVESTOR INQUIRIES:
    MC Services AG
    Anne Hennecke
    Tel.: +49 (0) 211-529-252-22
    Mail: relief@mc-services.eu

    Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner's application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    SOURCE: Relief Therapeutics Holdings AG



    View source version on accesswire.com:
    https://www.accesswire.com/657384/Relief-Reports-that-its-US-Collaboration-Partner-has-Announced-Emergency-Use-Authorization-of-Aviptadil-in-Nation-of-Georgia

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