Nrx Pharmaceuticals, Inc. · NASDAQ:NRXP
Nrx Pharmaceuticals — Investor Presentation (April 2022)
27 slides from Nrx Pharmaceuticals's investor presentation, April 2022
Slide 1: NRx Pharmaceuticals, Inc. Corporate Presentation April 2022
NRx Pharmaceuticals, Inc. Corporate Presentation April 2022 Nasdaq: NRXP
Slide 2: Disclaimer
Disclaimer 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 NRx Pharmaceuticals, Inc. (“NRx”) or
Slide 3: Overview
Overview
Slide 4: Multi-billion Dollar Potential in Psychiatry and Respiratory
Multi-billion Dollar Potential in Psychiatry and Respiratory Psychiatry Respiratory NRX-101 ZYESAMI® (aviptadil acetate) Bipolar depression with suicidality Critical COVID-19 (ARDS) Breakthrough Therapy designation & SPA Fast Track • First “composition of matter” patented NMDA-targeted antidepressan
Slide 5: Leadership Team
Leadership Team Committed to rapid, cost efficient, and impactful drug development Robert Besthof, MIM – Interim Chief Executive Officer Ira Strassberg – Chief Financial Officer 25+ years of Neuroscience & specialty drug development. Former Global 30+ years of finance and accounting experience, incl
Slide 6: Experienced Board of Directors
Experienced Board of Directors Drug development, health policy, biosecurity Jonathan C. Javitt, MD, MPH 25 years in drug development Presidential-commissioned White House health advisor Co-Founder Participated in 6 successful drug and device launches Prof. Johns Hopkins University Blockbuster drugs
Slide 7: NRx R&D Pipeline
NRx R&D Pipeline Regulatory Indication Compound Pre-clinical Phase 1 Phase 2 Phase 3 Interactions PSYCHIATRY Bipolar Depression with Suicidal Ideation and Behavior Breakthrough Therapy Designation, SPA, Biomarker Letter of Support Severe Bipolar Depression NRX-100 / NRX-101™ in patients with ASIB Bi
Slide 8: NRX-101
NRX-101 8
Slide 9: Why target Suicidal Bipolar Depression?
Why target Suicidal Bipolar Depression? Suicide kills ~50,000 Americans annually* If you know two people with bipolar depression, one will attempt suicide If you know five people with bipolar depression, one will succeed *Centers for Disease Control – all suicides 9
Slide 10: NRX-101 offers a differentiated profile for Suicidal Bipolar Depression with an FDA agreed upon path to NDA
NRX-101 offers a differentiated profile for Suicidal Bipolar Depression with an FDA agreed upon path to NDA Phase 3 with FDA Breakthrough Therapy Designation NMDA – A Validated Mechanism FDA Agreed Upon Regulatory Path • Depression & Suicidality • Special Protocol Agreement, Breakthrough Therapy • E
Slide 11: The NRx Discovery: DCS
The NRx Discovery Simultaneous Blockade of NMDA and 5-HT2A D-Cycloserine & Lurasidone oral & non-addictive combination DCS Lurasidone (D-Cycloserine) 5-HT2A Receptor NMDA Receptor 5-HT2A Receptor DCS Modulates the gly Glycine site of the Psychosis Akathisia 5-HT-2A NMDA receptor blockade blocks the
Slide 12: STABIL-B Phase 2 Data in Patients with Severe Bipolar Depression
STABIL-B Phase 2 Data* in Patients with Severe Bipolar Depression, Acute Suicidal Ideation & Behavior (ASIB) If Phase 2 results are replicated in Phase 3, this will meet criteria for FDA approval • Five human studies have shown a positive effect of DCS on depression and/or suicidal ideation • Primar
Slide 13: Faster, more robust response, and reduction of suicidality remain the unmet need
Though numerous drugs have been approved for MDD and Bipolar Depression, faster, more robust response, and reduction of suicidality remain the unmet need Drugs for Major Depressive Disorder (“MDD”) Drugs for Bipolar Depression 123 and counting – all antipsychotics Warning Warning Increased Increased
Slide 14: A multi-billion dollar addressable market in Bipolar Suicidal Depression and future indications including PTSD
A multi-billion dollar addressable market in Bipolar Suicidal Depression and future indications including PTSD Market Potential $2-4BN for bipolar depression & Currently suicidality • No drug is approved for high unmet need of Bipolar Depression with ASIB or PTSD with suicidal ideation $5 BN Market
Slide 15: ZYESAMI®
ZYESAMI®
Slide 16: Mechanism of Action of ZYESAMI®
Mechanism of Action of ZYESAMI® Vasoactive Intestinal Peptide (VIP) is found in all mammalian species VIP believed to protect the alveolar type-II cell by: • upregulating surfactant production • blocking cytokine production • inhibiting coronavirus replication in the type-II cells Alveolar Collapse
Slide 17: ZYESAMI® Showed Benefit on Survival from COVID-19 Respiratory Failure
ZYESAMI® Showed Benefit on Survival from COVID-19 Respiratory Failure in Patients in our Phase 2b/3 Study in Critical COVID-19 Near Statistical Significance on primary endpoint: Alive and Free of Respiratory Failure at Day 60 (P=.085) • Statistical significance on survival alone (P=.03) Prespecified
Slide 18: Aviptadil Biologic effect in preventing IL-6 Cytokine Storm and Respiratory Distress Ratio
Aviptadil Biologic effect in preventing IL-6 “Cytokine Storm” and Respiratory Distress Ratio seen in P2b/3 and open-label trials Two Prespecified Biomarkers associated with improved clinical outcomes Effect ofIL-6 Trajectory Aviptadil on IL-6 Trajectory Respiratory RespiratoryDistress Ratio* Distres
Slide 19: ZYESAMI® Ongoing Clinical Trials
ZYESAMI® Ongoing Clinical Trials Government and Industry Sponsorship ACTIV-3b Critical Care (TESICO) – sponsored by NIH • Patients with Critical COVID-19 • IV administration of aviptadil and remdesivir Randomization: 1) aviptadil; 2) aviptadil + remdesivir; 3) remdesivir; 4) placebo • ZYESAMI is the
Slide 20: ZYESAMI® Positioned to fill a high unmet need in Critical COVID-19
ZYESAMI® Positioned to fill a high unmet need in Critical COVID-19 Critical COVID-19 ZYESAMI is a unique addition to standard of care as the only treatment with a pleitropic mechanism that helps protect the ATII Cell (surfactant production), addresses multiple cytokines, and inhibits virus replicati
Slide 21: ZYESAMI® COVID-19 Perspective
ZYESAMI® COVID-19 Perspective COVID-19 TO DATE COVID-19 FUTURE Likely to become endemic, similar to FLU spikes* • ~ 200k-300K** ICU / Critical COVID-19 cases per year; 2- 3 times as many Severe Cases • Adding to already existing 200K ARDS cases • Immunocompromised ~80 M Cases in US, 977K deaths: Pat
Slide 22: ZYESAMI® Commercial Path to Market
ZYESAMI® Commercial Path to Market Rapidly Scalable Infrastructure FDA-inspected Manufacturing Partner QP-inspected Manufacturing Partner Specialty Distribution & 3PL Logistics, Invoicing Commercial Services for EUA / NDA MSL, PV/MI, etc. 22
Slide 23: Multiple Applications for ZYESAMI® Across Respiratory Disorders
Multiple Applications for ZYESAMI® Across Respiratory Disorders Non-COVID market opportunity may exceed COVID market opportunity Mild Moderate Severe Critical COVID-19 & Life Cycle COVID-19 Outpatient Inhaled IV/Inhaled Sequalae Expect baseline COVID-19 to remain Sepsis-Related 200,000 US cases each
Slide 24: Summary
Summary
Slide 25: Financial Position
Financial Position NRXP NRx Cash Publicly traded on Position: Total Shares Potential NASDAQ following Outstanding: Earnouts as SPAC merger $27.6 million as disclosed in completed in May of 12/31/2021 66.4 million public filings 2021 shares as of $25 million 3/27/2022 raised in February 2022 25
Slide 26: Two Phase 3 Shots on Goal in Areas of Very High Unmet Need
Two Phase 3 “Shots on Goal” in Areas of Very High Unmet Need Multi-billion Dollar Potential in Psychiatry and Respiratory Psychiatry – NRX-101 Respiratory – ZYESAMI® Bipolar Depression with Suicidality Critical COVID-19 and other Diseases ✓ Breakthrough Therapy designation & SPA ✓ Fast Track designa
Slide 27: NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. Corporate Presentation April 2022 Nasdaq: NRXP
NRx Pharmaceuticals — Investor Presentation (April 2022) on 6ix