New Hope

NRX-100 - A Beacon of Light in the Darkness of Acute Suicidality and Depression

Hope. Science. Life.

With a Novel Breakthrough Drug, This Little-Known Biotech Company is on the verge of significant FDA results.

Of the thousands of drugs approved by FDA, only 544 have been designated as “Breakthrough Therapy.” NRX-101 is the first Breakthrough Therapy for Suicidal Depression

NRX-101 has the potential to offer the first ray of hope to patients with suicidal depression, potentially transforming NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) into a biotech blockbuster, with sales of $1 billion - $2 billion annually!

Today, the only FDA-approved treatment for suicidal depression is electroshock therapy and every approved antidepressant carries a warning that it may INCREASE the risk of suicide!

No FDA-Approved medication for Suicidal Depression

While NRx continues to develop NRX-101, it has already accumulated data proving that its ketamine product (NRX-100) is superior to placebo in reducing symptoms of suicidality and depression. Positive trials, funded by the US govt and the French govt with nearly 1,000 patients. The company has already been awarded FDA Fast Track designation for ketamine and has created a daughter company, HOPE Therapuetics to start selling the ketamine product THIS MONTH.

NRx has stated in writing that current investors in NRx will also be given shares in HOPE Therapeutics, which is planned to go public over the summer.

This biotech company an irresistible proposition, not to be overlooked.

And as a pivotal phase 3 trials for NRX-101 is being advanced, not only for suicidal depression, but also for chronic pain, positive developments could trigger a fundamental breakout!

Suicidality is a National Crisis

Suicide kills >50,000 Americans every year
Disproportionately affecting people with Bipolar Disorder

Suicide takes our best and brightest

NRx Bring Hope to Life

Breakthrough Medicines for Life- threatening CNS Diseases with Unmet Medical Needs

  • NRx holds the only known commercial IND for NRX-100 (IV Ketamine) to treat suicidal depression NRx is preparing to submit an NDA in Q1 ‘24, as recommended by FDA in its January 2023 meeting with NRx. In the meantime, however, HOPE Therapeutics will begin licensed sales of ketamine to DEA-licensed ketamine clinics under a nationwide pharmacy license.
  • Developing NRX-101 (D-Cycloserine & Lurasidone), the first daily, oral treatment for Treatment-Resistant, Suicidal Bipolar Depression

Greeting Investors!

As we embark on this transformative journey, NRx Pharmaceuticals (NASDAQ: NRXP) extends a warm invitation to join us in pioneering innovative solutions to combat the profound challenges posed by mental health disorders. At the forefront of our mission lies a steadfast commitment to addressing the urgent and pressing issue of suicidal depression.

Central to our groundbreaking endeavors is NRX-100, an intravenous ketamine formulation poised to redefine the treatment landscape for acute suicidality and depression. With its potential to offer rapid relief and hope to those in desperate need, NRX-100 represents a beacon of light in the darkness of despair. NRX-100 starts sales this month and is expected to turn NRx Pharmaceuticals (through its HOPE subsidiary) into a revenue-generating company in 2024!

The shorts who have driven the price of NRx into the gutter want you to think that this is another hopeless biotech that will go bankrupt long before it generates revenue. UNFORTUNATELY THE SHORTS ARE MISTAKEN!

Furthermore, our robust pipeline includes NRX-101, a breakthrough therapy designated by the FDA for the treatment of suicidal treatment-resistant bipolar depression and chronic pain. Leveraging the power of D-Cycloserine (DCS) in combination with lurasidone, NRX-101 holds immense promise in providing much-needed relief to individuals grappling with these debilitating conditions

Beyond psychiatric disorders, NRx Pharmaceuticals is dedicated to addressing the complex challenges associated with chronic pain, post-traumatic stress disorder (PTSD) and complicated urinary tract infections (UTI) through the innovative potential of NRX-101.

As we continue to advance our pioneering research and clinical trials, we invite you to join us in our mission to transform the landscape of mental health therapeutics and beyond. Together, let us forge a path towards a brighter future, where innovative treatments offer hope and healing to individuals around the world. Join us in shaping the future of healthcare with NRx Pharmaceuticals.

NRx aims to provide state-of-the-art patient & reimbursement support for all of its patients and their clinics, ensuring access to insurance vulnerable populations”

By Matthew Duffy, Chief Business Officer

Key Overview

  • Sales of ketamine under FDA-inspected 503b pharmacy license begin NOW in March 2024.
  • Partnership in place with hundreds of ketamine clinics.
  • Completed Initial Manufacture of IV Infusion and Plans to File FDA New Drug Application for Acute Suicidality Upon Demonstration of 2-Year Shelf Stability.
  • Received $5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW)
  • NRXP Eligible for Additional $324 Million in Development & Sales Milestones, Plus Double-Digit Royalties Upon Approval and Commercialization of NRX-101.
  • Completing Enrollment for Phase 2b/3 Trial in Suicidal Treatment-Resistant Bipolar Depression in Cooperation with Lotus Pharmaceutical.
  • Incorporation of HOPE Therapeutics Dedicated to NRX-100 (IV Ketamine) for Suicidal Depression to Patients.
  • HOPE Therapeutics to be Initially Owned by NXRP and current NXRP Shareholders via a Planned Tax-Free Spinoff.
  • New Drug Application for NRX-100 (IV ketamine) Expected to be Filed in 1st Half of 2024.
  • Completion of Enrollment for Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression.
  • $5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW)
  • NRXP remains eligible to receive up to $320 million in future development and sales milestones, as well as royalty payments escalating to mid-teen percentages on Net Sales, subject to achievement of certain sales volumes. Additionally, Alvogen and Lotus will be responsible for future development and commercialization costs for the NRXP NRX-101 in treatment of bipolar depression with suicidality.

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) aims to bring hope to the market, improving the lives of thousands while maximizing shareholder value along the way!

Top Reasons to Have NRXP on Your Radar Right Now:

About the Company

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain.

NRx has recently announced plans to submit a New Drug Application for ketamine in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement.

NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.

Mission

NRx brings hope:
Life-saving medicines
For people living with unmet medical needs.

We believe in a world where scientific advancement makes untreatable diseases treatable.

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NRx Pharmaceuticals (Nasdaq:NRXP) Launches HOPE Therapeutics

HOPE Therapeutics, an NRx Pharma daughter company, is developing NRX-100 (IV Ketamine) for treatment of Acute Suicidality and Depression.

Learn more about how we are bringing hope to 3.5 million lives in the United States.

KEY UPDATES ARE AS FOLLOWS:

  • NRx management is proposing to award 50% of founding shares in HOPE Therapeutics to current shareholders together with a royalty coupon with an expected ex-dividend date in the near future, all subject to board approval
  • Dividend to be available to all shareholders who sign a covenant not to engage in short sales of NRx stock, subject to board approval
  • HOPE anticipates having manufactured ketamine supplies for shipment under 503a pharmacy regulations by July 1, 2024
  • HOPE Therapeutics is dedicated to bringing NRX-100 (IV Ketamine) for Suicidal Depression to patients
  • Company to be initially owned by NRx and current NRx shareholders via a planned tax-free dividend
  • A New Drug Application (NDA) for NRX-100 is expected to be filed in 1H24

"Subsequent to our announcement last week, we are in the process of completing a Memorandum of Understanding that may enable us to begin sales of IV ketamine to qualified clinics in partnership with a holder of a nationwide pharmacy license. Additionally, we will be updating investors with regard to our plans to add a digital therapeutic component to our ketamine offering that has potential to extend the clinical benefit to patients."

"We thank our investors for their support and look forward to updating the public on our progress towards building a lifesaving therapy."

By Dr. Javitt

"In a very difficult biotechnology capital market, we are pleased to benefit from the support of committed long-term investors, particularly in their willingness to purchase unregistered shares for the purpose of long-term appreciation. In the coming months, we expect to receive data from two important clinical trials, one in Suicidal Bipolar Depression and one in Chronic Pain, as well as advance our HTX-100 program in Suicidal Depression with the launch of Hope Therapeutics,"

By Stephen Willard, J.D., Chief Executive Officer of NRx Pharmaceuticals, Inc.

Pipeline

Leveraging our Multi-Billion Dollar NMDA Platform

Our Therapeutic Focus

Bipolar Depression & Suicidality

Bipolar disorder is an illness that affects approximately 7 million individuals in the USA. It can cause notable changes in a person’s mood, energy and ability to think clearly.

People with bipolar disorder experience high and low moods—known as mania (highs) and depression (lows). These common, severe mood changes are different and generally much more pronounced than the mood changes most experience.

Patients with Bipolar Depression are 20-30x more likely to attempt suicide than the general population. Over the course of 5 years, 1 in 5 patients suffering from Bipolar Depression will attempt suicide. Estimates indicate that 11-20% of those with Bipolar Disorder succumb to suicide.

Chronic-pain

Chronic Pain is at the heart of the Opioid Crisis
Few new drugs are on the horizon

NRX-101 may offer hope

The current opioid crisis, fueled by a failure of non-opioid medication to achieve meaningful clinical relief, creates an acute need for nonaddictive, non-sedating pain medication.

New academic and pre-clinical research shows that NMDA receptors are active at each step of the pain pathway: From the focal point of our pain, through the peripheral nervous system, up our Spinal cord to the brain.

D-Cycloserine (DCS), an active ingredient of NRX-101, is a potent NMDA antagonist at high-enough doses. We are developing NRX-101 to treat chronic pain by modulating the NMDA receptor at every step of the pain pathway.

Post-Traumatic Stress Disorder

PTSD can happen to anyone. It is not a sign of weakness. A number of factors can increase the chance that someone will develop PTSD, many of which are not under that person’s control.

PTSD occurs after people go through, or witness, life-threatening events. These can be single, traumatic instances, or intense, long-lasting traumatic experiences. These include war and combat, sexual assault, disasters and mass violence.

Anyone can develop PTSD, and its not under a person’s control. PTSD is also more common after combat or sexual assault.

Our Science

Targeting the brain’s NMDA receptor to lessen suicidal ideation

If you know five people with bipolar disorder, on average one will succumb to suicide. After centuries of mystery about the mechanism of bipolar disorder, major breakthroughs in unlocking the mystery began with Professor Daniel Javitt’s 1987 discovery that the NMDA receptor of the brain is the key to maintaining control over the rate at which thoughts are formed and the manner in which brain cells connect to one another.

Javitt’s work began with an attempt to explain the mechanism of drug-induced psychosis, a condition where people’s thoughts race out of control and hallucinations are common. Over the subsequent 25 years, it has become apparent that the NMDA receptor also has a major effect on depression and, particularly, thoughts of suicide. NRx is on a mission to bring hope to people who suffer from suicidal depression and PTSD through a new generation of NMDA-modulating medicines.

D-cycloserine, patented by Javitt as an antidepressant and antisuicidal drug, is approved worldwide as an anti-infective, primarily used for the treatment of tuberculosis. Although its anti-infective activity is based on its ability to disrupt bacterial cell walls, it also acts as an NMDA antagonist when used at high doses (> 500 mg). By targeting the NMDA receptor and modulating NMDA activity, D-cycloserine seems to foster a normal pace of thought generation. Multiple exploratory clinical studies have demonstrated that administration of D-cycloserine can trigger an antidepressant effect, as well as maintain a reduced level of suicidality.

NMDA Receptors

What is the NMDA receptor?

Humankind is only at the dawn of understanding brain chemistry. The world’s most advanced computer lacks the creativity of a human brain. In part, that’s because electronic computers are completely binary in their logic circuits. Circuits are hard-wired to one another. Electrical connections are either on or off. The brain, however, is an analog computer in which both chemical and electrical signals modulate brain cells, which are constantly forming and breaking connections to one another.

A Prevalent Problem:

Suicidal depression stands as a pervasive and urgent concern in our society, casting a shadow over the lives of millions worldwide. For those grappling with this debilitating condition, each day can feel like an insurmountable struggle, fraught with despair and hopelessness. Traditional treatment options often fall short, leaving many individuals trapped in a cycle of anguish with limited avenues for relief.

However, amidst the darkness, a beacon of hope emerges in the form of NRX-100 (IV Ketamine) from NRx Pharmaceuticals (Nasdaq: NRXP). This groundbreaking therapy offers a glimmer of light for those battling acute suicidal depression, providing a novel approach to intervention and potentially saving countless lives. With NRx Pharmaceuticals' innovative solutions and unwavering commitment to addressing mental health challenges, there is newfound optimism for a future where the grip of suicidal depression is loosened, and individuals find solace and healing.

The Solution:

In response to the pervasive problem of suicidal depression, NRx Pharmaceuticals (Nasdaq: NRXP) presents a groundbreaking solution: NRX-100 (IV Ketamine). This innovative therapy offers a ray of hope for individuals grappling with acute suicidal depression, providing a path towards healing and recovery.

NRX-100, developed by NRx Pharmaceuticals, represents a paradigm shift in the treatment landscape, offering a novel approach to addressing the profound challenges of suicidal depression. With its potential to provide rapid relief and alleviate symptoms, NRX-100 stands as a beacon of light in the darkness, offering renewed hope to those who have long struggled in silence.

Moreover, NRx Pharmaceuticals' dedication to advancing research and development in mental health extends beyond suicidal depression. With initiatives such as NRX-101 for chronic pain, D-Cycloserine (DCS) for PTSD, and NRX-101 for complicated UTI, the company is poised to revolutionize treatment across a spectrum of conditions, offering comprehensive solutions to complex challenges.

Clinical trials for NRX-100/NRX-101

NRx is currently investigating our approach in FDA clinical trials. Results from our STABIL-B phase 2 study were presented at the American College of Neuropsychopharmacology in December 2018, and the FDA granted breakthrough therapy designation (BTD) to NRX-101 based on this study.

Clinical Data

Results from NRx Pharma’s STABIL-B trial, a phase 2 study were presented at the American College of Neuropsychopharmacology in December 2018. The FDA granted breakthrough therapy designation (BTD) to NRX-101 based on this study.

A full, peer-reviewed report of the STABIL-B Trial is published in the International Journal of Bipolar Disorders and can be found here.

Award of QIDP and Fast Track Designations

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

  • NRX-101 has demonstrated potent activity against resistant urinary pathogens upon FDA review
  • QIDP designation grants Priority Review and an additional 5 years of additional product exclusivity
  • 3 million Americans develop complicated Urinary Tract Infection (cUTI) each year at a cost that ranges from $4497 to $17,431 with a high rate of antibiotic resistance and need for inpatient hospitalization
  • Unlike many advanced-generation antibiotics, NRX-101 is not contra-indicated in sulfa and penicillin allergic patients and is not believed to disrupt the normal intestinal microbiome, potentially leading to reduced risk of C. difficile infection
  • Data have been accepted for posting on biorxiv and are under review at a peer-reviewed journal

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Reports Comments by Strategic Partner Lotus Pharmaceutical.

"We at NRx are honored that Lotus has focused its resources on helping us advance NRX-101 for the benefit of patients in the Asia Pacific region. As reported by the World Health Organization, suicidal depression is a significant public health crisis in Pacific rim countries, just as it is in the US,"

"We recently held very productive meetings at the JP Morgan conference in San Francisco; we share a mutual commitment to bringing a lifesaving treatment to patients who have been excluded from the clinical trials of all known antidepressants and whose only approved treatment today is electroshock therapy."

By Stephen Willard, Chief Executive Officer of NRx Pharmaceuticals.

NRx Pharmaceuticals Announces Signing of a Data and Technical Information Agreement with Columbia University Accessing Key Data Demonstrating Efficacy and Safety of Intravenous Ketamine for the Treatment of Suicidal Depression

"We at NRx are delighted to partner with the thought leaders at Columbia University to help seek FDA approval for this extraordinary public health need. Until now, the only FDA-approved treatment for suicidal depression has been electroshock therapy (ECT). Recent literature suggests that ketamine may actually be superior to ECT in reducing suicidal ideation, while certainly having a more benign side effect profile,"

"Although ketamine is widely used off-label in the United States and is considered standard of care by some professionals, until it is labeled for treating depression and suicidality it will be widely accessible only to those patients able to pay out of pocket for their care and will continue to be subject to various warnings about off label use of a controlled substance."

By Dr. Jonathan Javitt, Founder and Chief Scientist of NRx Pharmaceuticals.

Recent News

In Summary…

At NRx Pharmaceuticals (Nasdaq: NRXP), we're not just tackling challenges; we're pioneering solutions in the realm of mental health. With our groundbreaking therapies, including NRX-100 (IV Ketamine) for acute suicidal depression and NRX-101 for chronic pain, PTSD, and complicated UTI, we're at the forefront of innovation in biopharmaceuticals.

Our focus on addressing the prevalent issue of suicidal depression with NRX-100 exemplifies our commitment to making a tangible impact on mental health. This therapy offers rapid relief, providing a lifeline to those in their darkest moments, while our ongoing research into NRX-101 promises advancements in the treatment of various CNS disorders.

Investors keen on tapping into transformative opportunities should have NRXP on their radar. With a diverse pipeline targeting critical unmet needs, NRx Pharmaceuticals offers a compelling investment opportunity. The recent "Strong Buy" rating on Nasdaq and a target price of $3.75, based on analysts' projections, underscore the market's confidence in our potential for growth and success.

Furthermore, as we advance pivotal Phase 3 trials for NRX-100 and continue to achieve milestones with NRX-101, the momentum is building for NRXP. Positive developments could trigger a fundamental breakout, offering investors the chance to capitalize on our trajectory towards becoming a leader in mental health therapeutics.

In summary, NRx Pharmaceuticals represents more than just a biotech company; we're agents of change in the fight against mental illness. With a robust pipeline, strong market indicators, and a dedication to innovation, NRXP is poised to deliver value to investors while making a profound difference in the lives of countless individuals worldwide.

This is an exciting time to have the stock on your watchlist!

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