Nrx Pharmaceuticals, Inc. · NASDAQ:NRXP
Nrx Pharmaceuticals — Investor Presentation (January 2022)
45 slides from Nrx Pharmaceuticals's investor presentation, January 2022
Slide 1: NRx Pharmaceuticals Corporate Presentation
NRx Pharmaceuticals Corporate Presentation January 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 or any of its subsidiaries, stoc
Slide 3: Overview
Overview
Slide 4: Develop / Manufacture / Commercialize
Develop/ Manufacture / Commercialize • Much of biotech seeks to exit on first proof of efficacy, we are building to launch • Late-stage biotech is delayed more often by formulation and CMC than by efficacy data • Partnerships are in place to develop, manufacture, launch, and sell • Three phase 3 “sh
Slide 5: Key Value Drivers in 2022
NRx Pharmaceuticals: Key Value Drivers in 2022 Possible three “shots on goal” in 2022 1H 2022 1H 2022 ZYESAMI ACTIV-3b data expected NRX-101 P3 SPA Breakthrough Initiation potential $2 Billion peak sales ZYESAMI NDA filing if ACTIV-3b is positive Bri-Life first GMP production 2H 2022 2H 2022 BriLife
Slide 6: Experienced Leadership Team
Experienced Leadership Team Committed to rapid, inexpensive, and impactful drug development Jonathan C. Javitt, MD, MPH – Founder, Chairman, CEO Alessandra Daigneault, JD – Chief Corporate Officer, General Counsel, Secretary 25 years in drug development. Participated in 6 successful drug and device
Slide 7: Experienced Board of Directors
Experienced Board of Directors Drug development, health policy, biosecurity Jonathan C. Javitt, MD, MPH – Founder, Chairman, CEO • 25 years in drug development. • Participated in 6 successful drug and device launches. Lt. General H.R. McMaster (US Army, Retired) • Blockbuster drugs at Merck, Allerga
Slide 8: NRx R&D Pipeline
NRx R&D Pipeline Indication Compound Pre-clinical Phase 1 Phase 2 Phase 3 Marketed BIPOLAR DEPRESSION | SUICIDAL IDEATION Severe Bipolar Depression in patients with NRX-100/NRX- SPA, Fast Track, Acute suicidal ideation 101™ Breakthrough, Biomarker COVID-19 Critical COVID-19 with Respiratory Failure
Slide 9: NRX-101
NRX-101
Slide 10: 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 10 *Centers for Disease Control
Slide 11: NRX-101 for Suicidal Bipolar Depression and PTSD
NRX-101 for Suicidal Bipolar Depression and PTSD NRX-101 has advanced to Phase 3 with FDA Breakthrough Therapy Designation • NMDA antagonist mechanism for suicidal depression is now well understood and validated by Spravato® (esketamine) approval and Axsome AXS-05 NDA submission • The unmet need is
Slide 12: Early IP Position: 30+ issued patents
Early IP Position: 30+ issued patents NRx has Composition of Matter Patent Protection Composition of matter patent for NRX-101 Allowed Claims • First patented NMDA drug for depression • Pharmaceutical composition for treatment of depression and associated suicidality with D- cycloserine (DCS)/ Luras
Slide 13: STABIL-B Phase 2 Data in 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 14: A $5 billion addressable market in suicidal depression and PTSD
A $5 billion addressable market in suicidal depression and PTSD Unmet medical need/life-threatening condition $2BN Peak sales opportunity • No previous drug has targeted Bipolar Depression with ASIB or for bipolar depression PTSD with suicidal ideation $5 BN • SSRI antidepressants have warning for i
Slide 15: ZYESAMI
ZYESAMI®
Slide 16: Why COVID primarily kills people
Why COVID primarily kills people (and not other mammals) All mammals can be infected by the SARS-CoV-2 virus, which generally causes mild symptoms but not respiratory failure and death. Humans are the primary mammal killed by the Coronavirus. The virus binds uniquely to the human form of Angiotensin
Slide 17: 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 17
Slide 18: The picture of COVID-19 is Alveolar Collapse
The picture of COVID-19 is Alveolar Collapse • With failure of surfactant production, alveoli collapse and are unable to support oxygen exchange • Aviptadil upregulates surfactant production in nonclinical studies • Rapid clearing of hallmark radiographic features seen in some patients (placebo-cont
Slide 19: ZYESAMI: Investigational Product for COVID-19
ZYESAMI® Investigational Product For COVID-19 and Other Respiratory Diseases • Results of FDA Phase 2b/3 randomized clinical trial (all patients all sites): • Primary endpoint “alive and free of respiratory failure at 60 days” is significant only when controlling for tertiary vs. community hospital
Slide 20: ZYESAMI Ongoing Clinical Trials
ZYESAMI Ongoing Clinical Trials Government and Industry Sponsorship ACTIV3b 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 - Favorable DSMB Re
Slide 21: Federal Government investment in ZYESAMI
The Federal Government has made the largest investment so far in ZYESAMI Decades of Funding to Stony Brook and other universities; ACTIV3b and I-SPY Trials "We started with about 600 [candidate compounds], and they had to be looked at, each one of them to see what was the evidence, and the likelihoo
Slide 22: ZYESAMI Improves Survival from COVID-19 Respiratory Failure
ZYESAMI® Improves Survival from COVID-19 Respiratory Failure in Patients Near Statistical Significance on primary endpoint (P=.08) on Primary endpoint and statistical significance on survival along (P=.03) (Statistical Significance when controlling for hospital type) Prespecified Endpoints: Alive an
Slide 23: FDA requested data on aviptadil vs. remdesivir
FDA requested data on aviptadil vs. remdesivir ZYESAMI® Improves Survival and Recovery from COVID-19 Respiratory Failure in Patients who continue to decline despite treatment with Remdesivir Prespecified Endpoints: Alive and Free of Respiratory Failure at 28 and 60 days (primary) Alive at 60 days (s
Slide 24: Biologic effect in preventing IL-6 Cytokine Storm
Biologic effect in preventing IL-6 “Cytokine Storm” seen in P2b/3 and open- label trials Prespecified Endpoint: Statistically associated with Improved Survival and Recovery at Day 60 • COVID-19 is associated with a sharp rise in inflammatory Effect of Aviptadil on IL-6 Trajectory cytokines • This “c
Slide 25: Biologic effect on Respiratory Distress Ratio
Biologic effect on Respiratory Distress Ratio (RDR) seen in P2b/3 and open- label trials Prespecified Endpoint: Statistically associated with Improved Survival and Recovery at Day 60 • RDR measures the ability of the lung Effect of Aviptadil on Respiratory Distress to transmit oxygen to the Ratio bl
Slide 26: ZYESAMI Positioning in Critical patients
ZYESAMI Positioning: Only therapeutic so far with large effect in Critical patients 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 inhibit
Slide 27: 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 • 52 M Cases in US, 816K deaths • Critical & Severe CO
Slide 28: ZYESAMI: Commercial Path to Market
ZYESAMI: Commercial Path to Market United States EMA/UK Rapidly Scalable Infrastructure Rapidly Scalable Infrastructure FDA-inspected QP-inspected Manufacturing Partner Manufacturing Partner TBN Specialty Distribution & Specialty Distribution & 3PL Logistics, Invoicing 3PL Logistics, Invoicing TBN C
Slide 29: 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 Outpatient Inhaled IV/Inhaled Sequalae COVID-19 Expect baseline COVID-19 to remain • 200,000 US cases each year1 Future
Slide 30: BriLife – A Novel COVID-19 Vaccine
BriLife™ – A Novel COVID-19 Vaccine
Slide 31: IIBR and NRx sign MOU to commercialize BriLife
Uy MMAOM NMI HBR MEDIA & PUBLIC AFFAIRS BUREAU The Israel Institute for Biological Research and international pharma company NRx Pharmaceuticals have signed an MOU to complete trials and commercialize “BriLife”, the Israeli COVID vaccine Defense Minister, Benny Gantz: “This agreement is excellent ne
Slide 32: Vaccine Development – BriLife
Vaccine Development – BriLife VSV: Vesicular Stomatitis Virus platform • Platform developed by IIBR based on successful, FDA-approved Ebola vaccine. Proprietary modifications to host cell and media (serum free) by IIBR • 107 dose showed >70% immunity in Phase 2 trial • 108 dose targeting 90% immunit
Slide 33: A Sheep in Wolf's Clothing
HOW BRILIFE WORKS A Sheep in Wolf’s Clothing AREPLICATING VIRAL VECTOR VACCINE e ene 18 BriLife rVSV-AG-spike Replacing VSV-G with ’ a SARS-CoV-2 Spike xX = o wv New Spike forms oe may be added as 7 a variants are Vesicular stomatitis virus (VSV) can identified | infect insects, cattle, horses and p
Slide 34: Prime/Boost Vaccination in Phase 2
Medium 2x107 Prime/Boost Vaccination in Phase 2 Among Participants who Demonstrate Serologic Response • Neutralizing Antibody response at 2x107 vaccination dose approximates the response reported in convalescent patients • Anticipation of higher NT50 response at high dose (108) vaccination • P2 Read
Slide 35: High dose of Israeli-made vaccine gives long-lasting protection
TV: High dose of Israeli-made vaccine appears to give long-lasting protection TV: High dose of Israeli-made vaccine appears to give long-lasting protection 230 people who received such dosage of inoculation, still in trials, do not need to get a booster, but others who had lower dosage do need extra
Slide 36: Immunity against SARS-CoV-2 VOCs in vaccinated mice
Immunity against SARS-CoV-2 VOCs in BriLife vaccinated hACE2 Tg mice Morbidity — mortality vaccine _ ~ im, Challenge (+Viral loads 2dpi; Sdpi) 107 pfu 10’ pfu (435) (d21) Mortality Morbidity — Vaccinated - alpha challenge an Vaccinated - betta challenge 120. he > Vaccinated - gamma challenge seillli
Slide 37: BriLife equally effective against Delta Variant
BriLife is the first COVID vaccine to show equal effectiveness against Delta Variant mRNA vaccines have all shown loss of effectiveness against Delta variant with deaths in vaccinated people Two Explanations: • BriLife shows the whole spike protein to the immune system • As a live virus vaccine, Bri
Slide 38: Evolving VaccineCo Partnership
Evolving VaccineCo Partnership Public participation via NRXP shares • VaccineCo Partnership announced in NRx 8K Oct. 21, 2021 • BriLife tech transfer and scale-up initiated November 2021 • First GMP vaccine doses targeted June 2022 • 60% NRx/40% new shareholders prior to additional capitalization •
Slide 39: To Make million doses of Vaccine in month
To Make 1 million doses of Vaccine in 1 month OR 10,000 eggs One bioreactor High Environment Damage Minimal Environment Footprint Allergy Non-scalable No Allergy / Scalable 39
Slide 40: The Future of BriLife
The Future of BriLife Unique promise for intranasal vaccine BriLife binds to the Alveolar Type 2 cell, same target as ZYESAMI • This may enable BriLife to create immunity in the nose and lung, not just to create circulating antibodies solves the virus shedding problem • This may mean that BriLife
Slide 41: Enhanced Immunity with Intranasal vs Intramuscular
Enhanced Immunity with Intranasal vs Intramuscular vaccine i.n. i.m. 105 106 107 pfu Morbidity – mortality Boost Challenge (+Viral loads 2dpi) 106 107 pfu (d21) (d34) Pseudovirus neutralization NT50 prime NT50 boost 10000 10000 1000 1000 NT50 NT50 100 100 Intranasal Intramuscular 10 10 i.n i.n i.m i
Slide 42: Summary
Summary
Slide 43: Financial Position
Financial Position NRXP Merger with Big Rock Partners Acquisition Corp. (BRPA) completed in May 2021 NRx Cash Position: • $38.9 million as of 9/30/2021 Total Shares Outstanding: 58.8 million shares as of 11/12/2021 Potential Earnouts as disclosed in public filings 43
Slide 44: Key Value Drivers in 2022
NRx Pharmaceuticals: Key Value Drivers in 2022 Possible three “shots on goal” in 2022 1H 2022 1H 2022 ZYESAMI ACTIV-3b data expected NRX-101 P3 SPA Breakthrough Initiation potential $2 Billion peak sales ZYESAMI NDA filing if ACTIV-3b is positive Bri-Life first GMP production 2H 2022 2H 2022 BriLife
Slide 45: NRx Pharmaceuticals
NRx Pharmaceuticals Corporate Presentation January 2022 Nasdaq: NRXP
NRx Pharmaceuticals — Investor Presentation (January 2022) on 6ix