NRX Pharmaceuticals, Inc. · NASDAQ:NRXP
NRX Pharmaceuticals — Investor Presentation (December 2024)
32 slides from NRX Pharmaceuticals's investor presentation, December 2024
Slide 1: Hope Science Life: Corporate Overview
Hope Science Life NASDAQ: NRXP Corporate Overview December 2024 © NRx - All rights reserved |
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation (this “Presentation”) is provided for informational purposes only. No representations or warranties, express or implied are given in, or in respect of, this Presentation. To the fullest extent permitted by law in no circumstances will Hope Therapeutics, Inc. (
Slide 3: Suicide is a Global Crisis
Suicide is a Global Crisis Suicidality kills ~50,000 Americans every year and 500,000 around the world Disproportionately affecting people with Bipolar Disorder Suicidality takes our best and brightest https://www.cdc.gov/suicide/facts/data.html © NRx 2023 - All rights reserved | 3
Slide 4: If you know two people with bipolar depression
If you know two peopleNRX-101 for PTSD with bipolar depression One will attempt suicide 50,000 Americans die of suicide each year 22 Veterans and Soldiers die of suicide every day Loss of more troops to suicide than to contact with the enemy No antidepressant today If you know five people reduces th
Slide 5: No FDA-Approved Medication Today for Acute Suicidality
No FDA-Approved Medication Today for Acute Suicidality Only FDA-approved therapy is IV Ketamine is used off-label Electro-Convulsive Therapy (ECT) But not FDA-approved Intranasal Ketamine (Spravato) is approved but majority practice remains IV Ketamine Recent panels at psychiatry meetings and eviden
Slide 6: NRx Clinical Programs – 2025 Path to Profitability
NRx Clinical Programs – 2025 Path to Profitability NRX-100 NRX-101 HOPE (IV Ketamine) (Oral DCS/Lurasidone) Therapeutics Interventional Psychiatry • Statistically-significant Bipolar Depression • Fast Track NDA in 2024 • A network of Suicidal Depression Phase 2 data: first Interventional Psychiatry
Slide 7: Potential to Reach 70+ Million Lives
Potential to Reach 70+ Million Lives Suicidal Bipolar Chronic Depression Depression Pain PTSD 3.5 M 7M 51 M2 12 M3 • 1 M Bipolar1 • 1 M Suicidal Global Opioid Crisis Currently 2 indicated • 2.5 M Other Depression1 SSRI drugs: Congressional forms of • 6 M Non- Funding for EPICNET • Neither relieves P
Slide 8: NRX-100 (IV Ketamine) for Suicidal Depression
NRX-100 (IV Ketamine) for Suicidal Depression Aiming to be the first FDA-approved ketamine product to treat suicidal depression © Hope 2024 - All rights reserved 8
Slide 9: Everyone is calling for approval of Ketamine
Everyone is calling for approval of Ketamine Why is IV Ketamine not approved for depression? 1 No Company has applied for FDA approval of IV Ketamine to treat depression No other Company has announced manufacture completion (i.e. FDA Module 3) 2 of an IV Ketamine formulation targeted for the treatme
Slide 10: Efficacy Data in hand to Support a Filing
Efficacy Data in hand to Support a Filing French Gov’t Funded: NIH Funded: PCORI Funded: Ketamine vs. Placebo Ketamine vs. Midazolam Ketamine vs. ECT Patient-Centered Outcomes Research Institute • 156 Patients, 7 Hospitals • Initial Randomization to • Superiority favoring • Admitted with acute suici
Slide 11: Noninferior to ECT in treating depression
Noninferior to ECT in treating depression © NRx 2024 - All rights reserved | 11
Slide 12: Broad Support within the Psychiatry Community
Broad Support within the Psychiatry Community Viewpoint Viewpoint October 25, 2023 January 3, 2024 Choosing Between Ketamine and The Rapidly Shifting Ketamine Electroconvulsive Therapy for Landscape in the US Outpatients With Treatment-Resistant Depression—Advantage Ketamine? Sanjay J. Mathew, MD; M
Slide 13: NRx Has Toxicity and Manufacturing Data in Support of NDA
NRx Has Toxicity and Manufacturing Data in Support of NDA 1 NRx met with FDA on neurotoxicity protocol in 2016 – Data were accepted 2 2023: NRx implemented formulation of preservative-free Ketamine 3 2023: First stability batch in BFS (blow-fill-seal; no glass) with modern container closure 4 2024:
Slide 14: Importance of Preservative-Free Ketamine
Importance of Preservative-Free Ketamine Benzethonium Chloride is good for killing germs, not for saving patients The preservative is in the bottle used for anesthesia only to enable hospitals to use the same bottle in multiple patients – a practice that is no longer legal in hospitals • From the ma
Slide 15: NRX-101 for Bipolar Depression with suicidality or akathisia
NRX-101 (Oral D-cycloserine/lurasidone) for Bipolar Depression with suicidality or akathisia Aiming to be the first non-ketamine, non-addictive non-psychedelic product to treat suicidal depression First Antidepressant to demonstrate reduced akathisia and suicidality In multiple clinical trials © Hop
Slide 16: NRX-101: Oral medication with potential for 2025 NDA filing
NRX-101: Oral medication with potential for 2025 NDA filing First oral antidepressant shown to reduce Suicidality & Akathisia Current efficacy and safety data support filing an NDA for Accelerated Approval 1 in the narrow indication of patients with suicidal bipolar depression and akathisia 2 Market
Slide 17: All Antidepressants Carry Black-Box Warnings for Suicidality and Akathisia
All Antidepressants Carry Black-Box Warnings for Suicidality and Akathisia no antidepressant has ever improved either side effect © NRx 2024 - All rights reserved | 17
Slide 18: NRX-101 demonstrates reduced Akathisia and Time to Suicidality Remission
NRX-101 demonstrates reduced Akathisia and Time to Suicidality Remission in Suicidal Bipolar Depression: No Ketamine Pre-treatment Phase 2b/3, randomized, double blind trial on NRX-101 vs Standard of Care (lurasidone) in Suicidal Treatment Resistant Bipolar Depression (n=93) Akathisia Rating by Stud
Slide 19: Prior Phase 2 Success (2018): STABIL-B trial
Prior Phase 2 Success (2018): STABIL-B trial Showed Superiority of NRX-101 vs Lurasidone in Reducing Depression (primary endpoint) after Ketamine Pre-treatment Patients received one infusion of IV Ketamine vs. placebo. Responders were randomized to NRX-101 vs lurasidone, a Standard of Care • Mean 7.
Slide 20: Potential Product Profile of NRX-101 in Suicidal Bipolar Depression
Potential Product Profile of NRX-101 in Suicidal Bipolar Depression • NRX-101 reduces depression scores by ~50% -- similar to SoC • NRX-101 is the only drug to demonstrate clinically meaningful reduction in akathisia and suicidality vs SoC We believe an antidepressant with this profile can become
Slide 21: NRX-101: Robust Composition of Matter Patent Protection
NRX-101: Robust Composition of Matter Patent Protection Patent Estate of 48 issued, 43 pending patents Enables a platform of CNS drugs based on NMDA / 5HT2A Synergy. • Five patent families, 90+ filed applications, 48 issued patents in US/EU/CN/JP/KR/AU. • Protects NRX-101 to at least 2033 with poten
Slide 22: NRX-101: Commercial-Ready Manufacture
NRX-101: Commercial-Ready Manufacture • GMP manufacturing initiated in the US in 2022 • Phase 3 drug, produced using expected Commercial Scale manufacturing process. • FDA Type C manufacturing meeting conducted in January 2022 with concurrence on CMC, stability, and etc. • 1 million phase 3 (commerc
Slide 23: HOPE Therapeutics
HOPE Therapeutics The first nationwide network of Interventional Psychiatry Clinics focused on suicidal depression and PTSD © Hope 2024 - All rights reserved 23
Slide 24: A Trailblazing Precision Psychiatry Network
A Trailblazing Precision Psychiatry Network A trailblazing precision psychiatry network providing interventional pharmaceutical therapy, TMS, Digital Therapeutics, and supportive therapy for suicidal depression, PTSD, anxiety, OCD and more. Our Mission To offer state of the art interventional psychi
Slide 25: We Need both the Means and Systems of Care
We Need both the Means and Systems of Care Ketamine does not belong in MedSpas or at home HOPE Therapeutics • A network of Interventional Psychiatry Clinics focused on ketamine and other lifesaving interventions for Suicidal Depression and PTSD • Psychiatrist led Currently 2 Global Opioid • Safety-f
Slide 26: Ketamine is not Enough: We Need a new System of Care
Ketamine is not Enough: We Need a new System of Care Ketamine must be supplemented with TMS, Digital Therapeutics and Supervised Care! TMS HOPE Digital Therapeutics Therapeutics • A network of Interventional Psychiatry Clinics focused on ketamine and other lifesaving interventions for Suicidal Depre
Slide 27: Pillars of HOPE Therapeutics
Pillars of HOPE Therapeutics Rewiring the brain in suicidal depression Patient Total Care Umbrella Precision Psychiatry and Medication Management Transcranial Ketamine and Digital Magnetic NMDA Therapy Therapeutics Stimulation © NRx 2024 - All rights reserved | 27
Slide 28: HOPE Therapeutics: Why Spin Out a Separate Company?
HOPE Therapeutics: Why Spin Out a Separate Company? Expected 2025 profitability NRx is a Biotechnology company focused on Research and Development 1 HOPE is a Care Delivery company focused on Interventional Psychiatry and digital therapeutics 2 Focus on TMS and Digital Therapeutics in addition to ke
Slide 29: Hope Therapeutics Near-Term Investor Highlights
Hope Therapeutics Near-Term Investor Highlights: Make Good Clinics Great • Acquisition and management of ~30+ Ketamine clinics through 2025 • Target $100 million/yr run-rate with positive EBITDA • Starting with industry-leading mental health practices that set the standard and scale for future acqui
Slide 30: Leadership Team
Leadership Team Jonathan Javitt, MD, MPH – Founder, Chairman & Rick Panicucci, PhD – Chief Technology Officer Chief Scientist; Co-CEO HOPE Therapeutics 25 years pharmaceutical manufacturing leadership and process 40 years in pharmaceutical and medical device development. development. Leader on multi
Slide 31: NRx/HOPE Scientific Advisory Board
NRx/HOPE Scientific Advisory Board Daniel Javitt, PhD, MD Gerard Sanacora, PhD, MD – REMS Chair George and Esther Gross Professor of Psychiatry at Yale Professor of Psychiatry at Columbia University. Initial University. Director, Yale Depression Research Program. Pioneer discovery on the role of NMD
Slide 32: Hope Science Life: Corporate Overview
Hope Science Life NASDAQ: NRXP Corporate Overview December 2024 © NRx - All rights reserved |
NRx Pharmaceuticals — Investor Presentation (December 2024) on 6ix