NRx Pharmaceuticals Corporate Presentation January 2022 - Nasdaq: NRXP
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NRx Pharmaceuticals
Corporate Presentation
January 2022
Nasdaq: NRXP
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, stockholders, affiliates, representatives, partners, directors, officers, employees, advisers or agents be responsible
or liable for any direct, indirect or consequential loss or loss of profit arising from the use of this Presentation, its contents, its omissions, reliance on the information contained within it, or on
opinions communicated in relation thereto or otherwise arising in connection therewith. In addition, this Presentation does not purport to be all-inclusive or to contain all of the information that may
be required to make a full analysis of NRx. Viewers of this Presentation should each make their own evaluation of NRx and of the relevance and adequacy of the information and should make such
other investigations as they deem necessary.
Forward-Looking Statements
Certain statements included in this Presentation include “forward-looking statements” within the meaning of the federal securities laws with respect to NRx and its business, including without
limitation, the drugs under development by NRx, the markets in which it operates, and NRx’s expectations with respect to future performance. NRx’s actual results may differ from its expectations,
estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements generally are identified by
the words “aspire,” “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “will be,” “will continue,” “will likely result,” “could,” “should,” “believe,” “predicts,”
“potential,” “continue,” “future,” “opportunity,” “strategy,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks
and uncertainties that could cause actual results to differ materially from expected results. Most of these factors are outside of NRx’s control and are difficult to predict. Factors that may cause such
differences may include the future financial and operating results of NRx; inherent uncertainty associated with the FDA approval process; changes in applicable laws or regulations; the possibility
that NRx may be adversely affected by economic, business, and/or competitive factors; the impact of COVID-19 or other adverse public health developments. NRx cautions that the foregoing list of
factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. NRx does not undertake or accept any
obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or
circumstances on which any such statement is based.
Industry and Market Data
Industry and market data used in this Presentation have been obtained from third-party industry publications and sources as well as from research reports prepared for other purposes. NRx has not
independently verified the data obtained from these sources and cannot assure you of the data’s accuracy or completeness. This data is subject to change without notice.
Trademarks
NRx and related marks are registered trademarks or trademark applications of, or are otherwise owned or used by, NRx or its affiliates. Any trademarks, trade names or service marks of other
companies appearing herein are the property of their respective owners. Solely for convenience, the trademarks, service marks and trade names referred to in this Presentation may appear without
the ®, TM or SM symbols, but the absence of such references does not indicate the registration status of the trademarks, service marks and trade names and is not intended to indicate, in any way,
that NRx will not assert, to the fullest extent under applicable law, rights to such trademarks, service marks and trade names.
Caution against inferences
This presentation is not a comprehensive presentation of NRx development programs and will discuss selected products and advances. The information presented is based on our current
understanding of biotechnology development and marketing programs that are subject to change as science evolves. In particular, no inferences should be drawn about programs that are not
mentioned or discussed in this, or any investor presentation offered by NRx.
2
Overview
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 “shots on goal”, each with multi-billion dollar potential in CNS and Respiratory
• Success on any one of three is likely to yield substantial return to investors
• NRX-101 for suicidal bipolar depression with Breakthrough Therapy Designation & Special Protocol Agreement first
“composition of matter” patented NMDA-targeted antidepressant
• ZYESAMI® (aviptadil acetate):
− Fast Track designation to treat Critical COVID-19
− Indication of efficacy in sepsis-related ARDS
− Indication of efficacy in Sarcoidosis
• BriLife™ multi-variant COVID-19 vaccine in partnership with Israel Institute for Biological Research (IIBR)
4
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 EUA filing if positive ZYESAMI NDA approval
P2/3 data if positive P3 data
potential $1-2 Billion peak sales
(depending on RLF settlement)
Potential for BriLife marketing
approval
potential $5 Billion peak sales
ZYESAMI Sepsis ARDS P3 initiation
5
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
launches. Blockbuster drugs at Merck, Allergan, Eyetech. Presidential- M&A partner at leading law firms. Chief Counsel, Teligent and successor
commissioned White House health advisor. Prof. Johns Hopkins University public companies
Randy Guggenheimer, MBA – Chief Business Officer Daniel C. Javitt, MD, MPH – Chair, Scientific Advisory
25 years in Life Science Investment Banking. Senior positions at Lehman Board
Inventor, NRX-101. International thought leader in neurochemical basis of psychiatric
Brothers, Dresdner. Kleinwort Wasserstein. Significant experience in life
conditions. Prof. Columbia University
sciences financings, M&A
Robert Besthof, MIM – Chief Commercial Officer Philip Lavin, PhD – Lead Methodologist
25+ years of Neuroscience & specialty drug development. Former Global 40 years of CRO and Clinical Trials. 60+ Drug and Device Approvals
VP (Commercial), Pfizer Neuroscience. Led major portfolios in Psychiatry Expert Consultant to FDA. Prof. Harvard University
incl. Pristiq / Zoloft. Affiliate & global positions at Lilly, Wyeth, Pfizer
Dennis McBride, Ph.D. ( CAPT. USN, SES-3, Ret.) Rick Panicucci, PhD – CMC and Manufacturing
Clinical Psychologist / Navy Flight Surgeon. Former DARPA Senior Program 25 years manufacturing leadership. Head of CCP, Novartis. VP of Manufacturing,
Leader. Prof. National Defense University. President Emeritus, Potomac WuXi Apptec
Institute
6
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, Allergan, Eyetech. • Former US National Security Advisor
• Presidential-commissioned White House health advisor
• Prof. Johns Hopkins University
Patrick Flynn, MBA – Chair, Audit Committee
Chaim Hurvitz
• 30 years senior executive experience
• Former Director and President, Teva International Group
• CEO Health Dialog – exit to BUPA International
• Chairman, CH Health
• Bank of America (15 years), VP World Banking and Risk Management
• BS Finance, Wharton School, University of Pennsylvania
Sherry A. Glied, PhD. – Dean, NYU Wagner
• Former Assistant Secretary for Health (ASPE)
• Health Economist, Mental Health Policy Expert
Aaron J. Gorovitz, JD
Daniel E. Troy, JD – Chair, Compliance Committee • General Counsel, AHG Group, Melbourne FL
• Former General Counsel, GSK
• Former Chief Counsel, U.S. Food & Drug Administration
7
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 Intravenous ZYESAMI®
(Avipdatil) Fast Track
Severe COVID-19 Inhaled ZYESAMI®
Fast Track
(Aviptadil)
BRILIFE™ COVID-19 VACCINE
SARS-CoV-2 BriLife™
ARDS
Acute Respiratory Distress Syndrome Intravenous Zyesami® Orphan Drug Designation
(Aviptadil)
8
NRX-101
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 ControlNRX-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 an orally-available NMDA drug that does not cause hallucinations, is not addictive (not scheduled),
is not neurotoxic, and is suitable for treatment of patients with bipolar depression
• NRx has pioneered a patented, dual-targeted mechanism of action (NMDA+5HT2A antagonism) in order to achieve a
high level of NMDA blockade without NMDA side effects
• Special Protocol Agreement, Breakthrough Therapy Designation, Biomarker letter of Support, and Fast Track
Designation
• NRX-101 pivotal study includes patients who are severely depressed and acutely suicidal in the hospital emergency
department
• Path to NDA filing in 1H2023
11Early 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)/ Lurasidone
• Five patent families, 60+ filed applications, 30+
issued patents in US/EU/CN/JP/KO/AU
• Other sponsors of NMDA-targeted drugs for
depression have no known composition of
matter patents
• Combinations involving dextromethorphan, d-
methadone, and S-ketamine are identified in the
spec of US 10,583,138
12STABIL-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
• Primary endpoint is mean MADRS score over 42 days of
observation analyzed by standard “Mixed Model”, which
is standard for repeated measures analyses in FDA
studies
• A clinically and statistically significant difference (p= .03)
was seen on the mixed model through day 42. The
mean 7.7 point difference on MADRS is similar to or
larger than that seen with Esketamine.
• 40% relapse in control group, no relapse in NRX-101
group
• Patients who would otherwise have been in the hospital
for two weeks and gotten electroconvulsive therapy
(ECT), went into remission, went home, and stayed
home
*www.clinicaltrials.gov//ct2/show/NCT02974010?term=neurorx&rank=4 13A $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 increased suicidality Peak sales opportunity
for PTSD
Physician/Payer studies demonstrate high receptivity
• ECT has significant limitations and side-effects, Hospitalization + 150,000
ECT costs $20,000–$49,000 per episode Admitted to psych
• High rate of rehospitalization/suicide attempts after discharge hospitals for ECT annually
• Rapid stabilization with ketamine and discharge after 1-2 days
with oral non-addictive drug (ketamine responders highly likely to 50,000
respond to NRX-101)* Avoidable deaths per year
$20,000+
Per patient cost of
hospitalization & ECT
14
*Kantrowitz, et alZYESAMI®
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
Converting Enzyme 2, which is found on the Alveolar Type II
Cell and starts a cascade that causes failure of oxygenation
in the alveolus and death within days
decreased surfactant production
inflammatory cytokine production
intracellular viral replication
cytopathy (cell death)
16Mechanism 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
17The 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-controlled results
pending)
• Blocks synthesis of IL-6 cytokine that produce characteristic inflammation of COVID-19 within the
Type II Cell
18ZYESAMI®
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 care (2 fold increased odds, PZYESAMI 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 Report Q32021; Expected readout H1 2022
I-SPY – sponsored by BARDA
- Patients with Severe and Critical COVID-19
- Inhaled administration of aviptadil in HFNC setting
"On April 22, 2021, NIAID and 9 NHLBI launched a
- Other investigational agents chosen by I-SPY new trial, known as ACTIV-3 Critical Care, to test
- Expected readout H1 2022 Zyesami and remdesivir (alone and in combination),
for their safety and efficacy in hospitalized COVID-
AVICOVID-2 – sponsored by NRx 19 patients who are experiencing acute respiratory
distress syndrome, a life-threatening condition.
- Patients with Severe COVID-19
Zyesami is a synthetic version of vasoactive
- Inhaled administration of aviptadil vs. placebo intestinal peptide, which is made naturally in the
- Planned inpatient and outpatient components human body and appears to have lung-protective
- Expected readout H1 2022 antiviral and anti-inflammatory effects.”
Dr. Anthony Fauci - Testimony before the United States
Senate Committee on Health, Education, Labor, and
Pensions 7/20/21
20The 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 likelihood that they could be
successful. And that meant what's the scientific basis of the
claim for benefit, but also something more practical, like
suppose it works, is there a manufacturing plan about how
you could actually develop a supply chain and provide this
to people if you had a successful outcome?.”
Dr. Francis Collins – Presentation to the Reagan Udall
Foundation “COVID-19 Lessons Learned” workshop
September 21, 2021
21ZYESAMI® 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 and Free of Respiratory Failure at 28 and 60 days (primary)
Alive at 60 days (secondary)
22FDA 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 (secondary)
Odds Ratio (95% CI)
Endpoint controlling for baseline severity, age with clinical site as a
random effect
Alive and Free of Respiratory Failure at 2.3 (.87 - 6.1)
Day 28 P=.09
Survival to Day 28 2.8 (1.1 – 7.1)
(may still be in hospital) P=.03
Alive and Free of Respiratory Failure at 3.1(1.13 – 8.34)
Day 60 P=.03
Appendix 1, p11, table 14
Survival to Day 60 4.1(1.5 11.5)
(may still be in hospital) P=.006
Appendix 1, p9, Table 10
23Biologic 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 “cytokine storm” is associated with
clinical deterioration and death
% Change, IL-6
in COVID-19
• Placebo patients demonstrated 5x
higher mean IL-6 cytokine at day 7
vs. aviptadil-treated patients(PBiologic 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
bloodstream and is used to define
Respiratory Failure on a
physiological level.
• Patients treated with aviptadil
demonstrated significant
improvement in RDR vs. placebo at
day 1 and over the first week (PZYESAMI 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 inhibits virus replication, that has
shown survival benefit at day 60 in Critical COVID-19.
Mild Moderate Severe Critical
Steroids
Inhaled ZYESAMI ZYESAMI
Actual / Recommended
Remdesivir*
use, and expected use
Key existing and Tocilizumab**
potential competitors in
Critical COVID-19 Baricitinib***
Lenzilumab****
* EUA May 1, 2020
** EUA June 25, 2021
*** amended EUA July 28, 2021
**** FDA request for more data September 2021
26ZYESAMI: 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 COVID Cases will require
combinations of various agents
- Pattern of spikes – rapidly strain regional ICU
capacity (1K-2K daily deaths since mid. Sep.) - Mortality in ICU similar to ARDS ~ 30%
• Fast evolving treatment algorithms • Vaccination rates increasing, but breakthrough and
- Critical COVID-19 key unmet need virulence of variants key uncertainty, until global
vaccination 70%+
• Vaccination hesitancy in US & low exUS rates;
emergence of strains
Source: CDC Dec. 29, 2021
* 2018-2019 FLU season estimated to account ~500K hospitalizations, 2017-2018 accounted for ~
800K hospitalizations. Source CDC
** internal estimate: 300 daily deaths at 30% mortality = 1,000 new ICU cases per day ~ 300K cases
per year
27ZYESAMI: 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
Commercial Services for Commercial Services for
EUA / NDA EUA / NDA
MSL, PV/MI, etc. MSL, PV/MI, etc.
28Multiple 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 R&D targets:
Sepsis-
• No approved drugs (synergy with COVID-19 study)
Related • 7 of 8 patient success in Phase 1
1. Dry powder inhaler
ARDS • Aim for 2022 Phase 2b/3 start
2. Long-Acting Peptide
• 185,000 US patients seek treatment each year2
• Primarily people of color / no approved drugs
Sarcoidosis • Positive Phase 2 open label POC data3
• Aim for H2 2022 Phase 2b/3 start
• Checkpoint Inhibitor Pneumonitis (10%-20%)4 – positive case reports
• Delay of lung transplant
Other • COPD (subtypes)
• Amniotic Fluid Embolus; main cause of mother’s death in delivery
1) Harman, E. et. al.; Acute Respiratory Distress Syndrome (ARDS), https://emedicine.medscape.com/article/165139-overview#a5, 03/2020
2) Hena KM; Sarcoidosis Epidemiology: Race Matters. Front. Immunol., 9/2020 11:537382.doi: 10.3389/fimmu.2020.537382
3) Prasse, A. et al.; Inhaled Vasoactive Intestinal Peptide Exerts Immunoregulatory Effects in Sarcoidosis, American Journal of Respiratory and Critical Care Medicine, 04/2010
4) Frye, B.C., et. al, Vasoactive Intestinal Peptide in Checkpoint Inhibitor–Induced Pneumonitis, NEJM 2020; 382:2573-2574NEJM
29BriLife™ – A Novel COVID-19 Vaccine
31
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% immunity
• Phase 2b/3 non-inferiority trial anticipated start Dec 2022
Protocol designed with advice from EMA and WHO
• Targeting improved immunity against variants because BriLife
presents the entire spike protein complex to the immune system
• Potential for mucosal immunity because vaccine binds to ACE2
receptor on Alveolar Type 2 lung cells
• Potential to avoid mRNA complications
32A Sheep in Wolf’s Clothing
33Medium 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 Readout expected early 2022
• Initiating P2/3 non-inferiority trial
in 20,000 subjects located in
Georgia, Ukraine, and additional
sites TBN.
34TV: 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 shot
3536
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,
BriLife evolves the way
the Corona Virus evolves
37Evolving 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
• More than 10 countries have already
reached out to request phase 3
participation
• Initial regulatory target EMA/UK
• €150 Million in proposed bank finance
Commercial Partnerships as
of November 2021. Refer to
Forward looking statements 38To 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
39The 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 is even
more effective as a nose spray than
as a traditional injection
40Enhanced 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.m
.
i.n
i.n
i.n
i.m
i.m
.
i.n
6
7
5
6
7
1e
1e
6
7
1e
1e
1e
5
6
7
1e
1e
1e
1e
1e
BriLife® intranasal immunization of K18 mice induces higher neutralizing antibodies at
lower doses than intramuscular immunization
Preliminary indications for a potential of a low dose-prime only protective vaccine 41Summary
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
43NRx 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 EUA filing if positive ZYESAMI NDA approval
P2/3 data if positive P3 data
potential $1-2 Billion peak sales
(depending on RLF settlement)
Potential for BriLife marketing
approval
potential $5 Billion peak sales
ZYESAMI Sepsis ARDS P3 initiation
44NRx Pharmaceuticals
Corporate Presentation
January 2022
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