Four near-term milestones, including
initiation of potential spinout initiatives expected in
2023/early 2024
- Completing enrollment of the originally-targeted 70 patients
in the Phase 2b/3 trial of NRX-101 in
Treatment Resistant Bipolar Depression; enrollment to continue
through November to increase study power; last patient visit
expected in January. Data expected to be released shortly
thereafter
- Opened the Investigational New Drug application (IND) with
Food and Drug Administration (FDA) to treat chronic pain with
NRX-101. Awaiting results of 200-person DOD-funded trial in
treatment of chronic pain with D-cycloserine (DCS) from
Northwestern University in the near
term
- Received data from randomized, controlled trials
demonstrating safety and efficacy of IV ketamine in treating
suicidal depression, and established manufacturing partnership to
enable filing of a New Drug Application (NDA) for what would be the
first FDA-approved presentation of IV ketamine for this purpose in
1Q24.
- Planning a newly capitalized, publicly traded,
ketamine-focused entity that will be owned by NRx, current NRx
shareholders, and new investors; Term Sheet received from
prospective anchor investor
- Submitted an IND application with FDA to treat
complicated Urinary Tract Infection (cUTI) with NRX-101; Qualified
Infectious Disease Product (QIDP) request response expected around
year-end 2023.
- Management to address evidence of naked shorting of NRx
securities
- Management to host a conference call tomorrow, November 14, 2023, at 4:30
PM ET
RADNOR,
Pa., Nov. 13, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced its financial results for the quarter ended September 30, 2023 and provided a business
update. Given the volume of information discussed this
quarter, we have issued this release in advance of our conference
call to allow investors additional time to review.
"The third quarter represents a potential turning point for our
company, as we are approaching our clinical trial enrollment goals
for our partnered foundation product NRX-101, while opening new
clinical initiatives in chronic pain, urinary tract infection, and
NRX-100 for suicidal depression," said Stephen Willard, J.D., Chief Executive Officer
and Director of NRx Pharmaceuticals. "We have four upcoming
milestones: in our core clinical trial of NRX-101, in the
Department of Defense (DOD) -funded clinical trial of DCS for
chronic pain, in our program to open an IND and secure QIDP
classification for NRX-101 in cUTI, and in our program to seek New
Drug Approval for NRX-100 (intravenous ketamine) and establish that
drug in a freshly-capitalized company. Achieving any one of those
milestones has the potential to unlock substantial shareholder
value, while success on more than one front has the potential to
unlock exponential growth.
"I am incredibly proud of our team, our collaborators &
partners, and most of all the patients who have made such important
contributions to these efforts. All of us at NRx are deeply
grateful to the many shareholders who have reached out to us,
encouraged us, and supported us during a period of immense
challenge in the biotechnology market. Together, we are pursuing
NRx's goal of bringing hope to life on a daily basis."
Third Quarter Clinical, Regulatory and Corporate
Highlights
Development of NRX-101 for Treatment-Resistant Bipolar
Depression (TRBD)
The Company announces today that it is near completion of
enrollment of the originally-targeted 70 participants in the Phase
2b/3 trial of NRX-101 in TRBD;
enrollment will continue through November to increase study power.
We expect top-line data from this cohort of patients shortly after
the last patient visit. The target population is based on the
Company's January 2023 meeting with
the FDA in which the Company was guided to expand its intended use
of NRX-101 from the original population of patients with acute
suicidality who might be treated in the hospital environment to the
broader population of patients with subacute suicidal ideation (now
described by the Company as Treatment-Resistant Bipolar Depression)
who are treated in the outpatient setting.
Based on the guidance of the FDA and the Company's completion of
manufacturing for phase 3/commercial stage investigational product,
the Company upgraded the ongoing clinical trial to a phase
2b/3 trial, the results of which have
the potential to be used for registrational filings. The data
integrity standard identified last quarter (95% agreement between
site raters and central raters) has been achieved across the
newly-enrolled cohort of patients.
In April 2023, the Company
contracted with 1nHealth to initiate a recruitment campaign that
may cover up to 45 states in the U.S. to recruit sufficient
participants for this enlarged trial. The Company has similarly
broadened its relationship with Science 37, a contract research
organization that conducts decentralized clinical
trials, to enroll participants identified by the 1nHealth
recruitment initiative and randomize them to be treated within the
broadened clinical trial. 1nHealth has additionally engaged "The
Mighty," a voice-of-the-patient organization with national reach to
publicize the clinical trial to the 800,000+ subscribers who have
indicated a focus on bipolar depression and suicidality.
The Company has completed manufacture of all clinical supplies
required for its ongoing clinical trials. This initiative is
expected to yield stability data sufficient to support a shelf life
in excess of two years at time of potential drug launch (should the
clinical trials be successful). The completion of this
manufacturing milestone may allow the Company to decrease ongoing
expenditure associated with manufacturing and development of
chemical manufacturing controls. Product stability work has
continued to support the targeted two-year shelf life at potential
drug launch.
During Q3, the Company has solidified its working relationship
with Alvogen and begun working in unison to plan the final
development and commercialization of NRX-101. As previously
announced, a successful readout from this trial and FDA interaction
will trigger a $10 million milestone
payment from Alvogen together with transfer of future development
costs to our partner.
Based on milestones achieved during this quarter, the NRX-101
project is on track for completion of a pivotal trial in
coordination with a commercial stage partner in less than two years
from its re-initiation in March 2022
at the tail of the COVID pandemic to its projected readout.
This includes the time required to complete transfer of
manufacturing to the US and to validate a full chemistry,
manufacturing and controls (CMC) and stability program with the
FDA.
NRX-101 for Treatment of Chronic Pain:
The Company has previously detailed the scientific basis for
treatment of chronic pain with DCS as outlined in a 2016 scientific
paper published by Schnitzer, et. al. and in the White Paper posted
by the Company's Scientific Leadership (Sappko, et. al.). In
the second quarter, the Company licensed US Patent
8,653,120 for the use of DCS in chronic pain and filed a
now-accepted Investigational New Drug (IND) application with the
FDA to initiate commercial drug development of NRX-101 in chronic
pain.
Chronic pain affects more than 50 million American adults,
compared to the approximately 3 million who report thoughts of
suicide on an annual basis. There has been no new non-opioid class
of drugs to treat nociceptive pain in the past two decades and
NRX-101 has the potential to be the first N-methyl-D-aspartate
(NMDA)-antagonist drug to seek approval for this indication. Today,
ketamine is used off label to treat nociceptive pain, despite its
clear limitations (addiction, neurotoxicity, hallucination, and the
need for IV administration.)
The Company awaits results of a 200-person randomized
prospective trial funded by the US DOD (NCT 03535688) in which
patients with chronic pain were randomly assigned to DCS 400mg/day
vs. placebo. The investigators have identified primary completion
of this trial as occurring in November
2023, with top-line results. Should these results support
efficacy of DCS in the treatment of chronic low back pain, they are
expected to provide a Breakthrough Therapy path towards treatment
of chronic pain with DCS and DCS-containing medicines.
Today, the Company is announcing that it has submitted NRX-101
for consideration by the multibillion dollar HEAL initiative (HEAL)
and its national consortium of clinical trial sites
(EPPICNET). This initiative was funded by the US
Congress to test innovative non-opioid medicines for Chronic Pain.
We believe that NRX-101 represents the first NMDA-targeted
non-addictive medicine to be presented to this program. Should the
DOD-funded trial yield encouraging data, the Company anticipates
that non-dilutive sources of capital will be available, given the
national focus on the opioid crisis. Progress in treating chronic
pain with NRX-101 may open a far larger market for NRX-101 than the
originally-targeted psychiatry indications.
Progress on NRX-100 (ketamine) for treating acute
suicidality.
When NRx met with the FDA in January
2023, the agency strongly encouraged the Company to develop
NRX-100 (ketamine) as a labeled drug, rather than rely on prior
stabilization of suicidality and depression achieved via the common
clinical practice of infusing generic ketamine compounded in
licensed pharmacies. Shortly thereafter, the FDA issued the first
of two advisory letters warning physicians against using compounded
forms of ketamine and began a program of rigorous inspections of
such pharmacies. Although there was once an expectation that
intranasal administration of ketamine would be effective in
treating suicidality, the attempts to demonstrate the clinical
efficacy of nasal racemic ketamine for acute suicidality have not
succeeded.
Accordingly, in Q3 the Company finalized a scientific
collaboration with Prof. Marion
Leboyer of Paris, France
and Prof. Mocrane Abbar of Lyon,
France in order to incorporate the results of a 156-person
inpatient trial of intravenous ketamine vs. placebo for the
stabilization of patients admitted for acute suicidality (the KETIS
trial). The findings of the trial demonstrate a statistically
significant reduction in both suicidality (the primary endpoint)
and depression (the secondary endpoint) among patients treated with
intravenous ketamine compared to those treated with placebo.
(Link)
The patient-level deidentified data have now been received by
the Company and are being assembled in the electronic format
required by the FDA. The Company is now in the process of
negotiating access to similar patient-level data from an National
Institutes of Health (NIH)-funded US-based clinical trial the
findings of which confirm the KETIS trial. The Company believes
that these multicenter, randomized prospective trials encompassing
more than 240 participants, combined with randomized, prospective
data on more than 200 US patients when submitted for review at a
patient level could be sufficient to demonstrate preliminary safety
and efficacy of intravenous ketamine in acutely suicidal patients.
Data are expected to be transmitted to FDA by the end of 4Q23.
Submission of an NDA for the use of IV Ketamine is dependent
upon submission of a manufacturing file documenting the manufacture
of a presentation of ketamine suitable for single-patient use in
the treatment of suicidal depression. In November 2023, the Company announced the signing
of a development and manufacturing agreement with Nephron
Pharmaceuticals, Inc. (West Columbia,
SC) to develop a single patient presentation of
ketamine. This formulation is expected to overcome some of
the formulation deficiencies of existing forms of ketamine
(developed for anesthesia) and is expected to have
diversion-resistant and tamper-resistant features. The Company
believes that this latter aspect is important because of the
well-known uses of ketamine as a drug of abuse and as a vehicle for
date rape. DOJ Date Rape Drugs
The Company's current timeline projects submission of a New Drug
Application for ketamine in the first quarter of 2024 with a
targeted PDUFA date in Q4 2024. Nephron has considerable experience
in the manufacture of ketamine products and, therefore, the Company
anticipates that two-year shelf stability at launch may be achieved
with six months of real-time accelerated stability.
Establishment of a ketamine-focused spinoff company
The Company does not anticipate funding this initiative with its
core NRx assets and today advised investors of its plan to
establish a ketamine-focused spinoff company that would potentially
provide current and new investors with both capital appreciation
and a royalty stream. A term sheet for up to $30 million in anchor financing for a new public
entity has been presented to management by a capable investor and a
structure whereby a portion of the equity in the ketamine asset
will be allocated to existing shareholders. This proposal
will be discussed at the upcoming annual meeting of
shareholders.
There is an acute public health need for a safely manufactured,
divergent-resistant form of ketamine, particularly in light of drug
shortages caused by newly (and appropriately) rigorous FDA
manufacturing standards. NRx anticipates a near-term potential
address this public health need by year end 2024.
Treatment of Urinary Tract Infection (UTI) and Urosepsis:
Although treatment of UTI is quite different from use of NRX-101
to treat Central Nervous System disorders, D-cycloserine was
originally developed as an antibiotic because of its role in
disrupting the cell wall of certain pathogens. This is true of a
number of drugs used in psychiatry today. D-cycloserine fell out of
favor as an antibiotic in the 1970s because of the CNS effects
caused by its NMDA-blocking properties and because of the
widespread availability of effective first and second-generation
antibiotics.
However, DCS is unique in its near-100% excretion in the urine
and the ability to achieve high urinary tract levels of DCS with
oral administration. The Company's clinical experience in
psychiatry suggests that the lurasidone component of NRX-101 blocks
unwanted CNS effects and unlocks the potential to treat
antibiotic-resistant urinary tract infections with decreased
propensity to cause unwanted CNS effects.
In recent years, increased antibiotic resistance to common
pathogens that cause urinary tract infections and urosepsis (i.e.,
sepsis originating in the urinary tract) has resulted in a marked
increase in cUTI, hospitalization, and death from urosepsis. The US
Center for Disease Control and Prevention reports that more than
1.7 million Americans contract sepsis each year, of whom at
least 350,000 die during their hospitalization or are
discharged to hospice (CDC Sepsis Ref.). In 2015 DCS was
demonstrated to be effective against pathogens that are
increasingly resistant to first- and second-line antibiotics.
During Q3 2023, NRx tested NRX-101 and its components against
resistant pathogens that appear on the Congressionally-mandated
Qualified Infectious Disease Product (QIDP) list and proved in
vitro effectiveness against antibiotic-resistant E. coli,
Pseudomonas, and Acinetobacter – thereby appearing to meet the
requirements of the QIDP program.
Qualification for QIDP affords a sponsor five years of
additional market exclusivity from FDA, regardless of patent
status, together with Fast Track Designation and Priority Review.
The Company believes that NRX-101 as an oral medication has the
potential to demonstrate benefit in patients who would otherwise
require intravenous third and fourth generation antibiotics. There
are approximately 3 million patients per year who contract cUTI in
the US annually (Lodise, et. al.). Additionally, should NRX-101
succeed in clinical trials, the Company will consider developing a
follow-on product that is anticipated to achieve another 20 years
of patent exclusivity.
Based on the in vitro study performed at CRL, the Company has
submitted an Investigational New Drug application, requesting QIDP,
Fast Track, and Priority Review designation. FDA approval of this
IND is expected by year-end 2023.
As with the NRX-100 development project, the Company does not
anticipate funding this initiative with core NRx assets and is
exploring structures for a new entity that would provide current
and new investors with both capital appreciation and a royalty
stream. Should the Company succeed in serving 10% of the cUTI
market, the Company believes that the revenue from NRX-101 has the
potential to hundreds of million annually, based on 3 million cases
per year (Lodise, et. al.) in the US and potential pricing of over
$3,500/course of therapy.
Cash runway and financing
The Company continues to believe cash on hand is sufficient to
fund operations through potential delivery of the upcoming
milestones described herein. As discussed, funding of
ketamine-related and UTI-related initiatives is anticipated under
new entities with alternative financing. Additional financing
plans to be discussed at the upcoming meeting of shareholders.
Share price suppression associated with Naked Shorting
Shareholders and others have repeatedly noted that the Company's
share price appears to be adversely affected by short sales of
stock that frequently accompany positive news. While covered short
sales (i.e. those sales that are accompanied by borrowing of an
existing share of stock) is legal, "naked" shorting, without an
underlying borrowed share, is not. A recent Federal Court decision
holds brokerages liable for damages to companies associated with
persistent naked short positions.
In Q3, the Company contracted with ShareIntel, Inc. to examine
disparities between NRx stock positions as reported by brokerages
and NRx shares reported by DTC, the electronic clearinghouse for
the Nasdaq exchange. The Company is today announcing that
persistent disparities of approximately 1 million to 1.5 million
shares were identified. The Company's has now instructed its
counsel to initiate outreach to the compliance departments of the
identified brokerages, demanding that all uncovered short positions
in the Company's stock be closed via a forced delivery of shares.
The Company has been advised by counsel that this action has
resulted in share appreciation when implemented by other issuers of
Nasdaq stock.
Financial Results for the Second Quarter Ended September 30, 2023
For the three months ended September
30, 2023, NRx Pharmaceuticals recorded $3.3 million of research and development expenses
compared to $4.1 million for the
three months ended September 30,
2022. The decrease of $0.8
million is related primarily to a decrease of $0.5 million in clinical trials and development
expenses related to the NRX-101 program for Suicidal
Treatment-Resistant Bipolar Depression partially offset by a
increase in various other costs.
For the nine months ended September 30,
2023, NRx Pharmaceuticals recorded $10.8 million of research and development
expenses compared to $12.6 million
for the nine months ended September 30,
2022. The decrease of $1.8 is
related primarily to a decrease of $1.0 million in clinical
trials and development expenses, $0.9 million related to
fees paid to regulatory and process development
consultants, $0.2 million in stock-based compensation,
partially offset by an increase in various other costs.
For the three months ended September 30,
2023, NRx Pharmaceuticals recorded $2.5 million of general and administrative
expenses compared to $5.0 million for
the three months ended September 30,
2022. The decrease related primarily of a decrease
of $1.3 million in insurance
expenses, $0.9 million in employee
expenses, $0.2 million in stock-based compensation
expense, $0.3 million in legal, professional and
accounting fees partially offset by an increase in various other
costs.
For the nine months ended September 30,
2023, NRx Pharmaceuticals recorded $12.3 million of general and administrative
expenses compared to $21.9 million
for the nine months ended September 30,
2022. The decrease of $9.5
million is related primarily to a decrease
of $4.9 million in legal, professional and
accounting fees, $2.8 million in insurance
expenses, $1.1 million in stock-based compensation
expense, $0.5 million in consultant
fees, $0.4 million in employee expenses, partially offset
by an increase in various other costs.
For the three months and ended September
30, 2023, NRx Pharmaceuticals recorded $6.1 million in net loss compared to $9.1 million for the quarter ended September 30, 2022. For the nine months and ended
September 30, 2023, NRx
Pharmaceuticals recorded $25.8
million in net loss compared to $29.5
million for the quarter ended September 30, 2022.
As of September 30, 2023, we had
$8.9 million in cash and cash
equivalents. The company continues to believe cash on hand is
sufficient to fund operations through potential delivery of the
upcoming milestones described herein. Additionally, we are
evaluating operational efficiencies to extend this runway.
Conference Call and Webcast Details
A live webcast of the conference call will be available on the
Company's website tomorrow at 4:30 p.m.
ET, at https://ir.nrxpharma.com/events. An archive of
the webcast will be available on the Company's website for 30
days. Participants that are unable to join the webcast can
access the conference call via telephone by dialing domestically +1
(833) 630-1956 or internationally +1 (412) 317-1837.
About NRX-101
NRX-101, a fixed dose combination of D-cycloserine and
lurasidone, has been granted Fast Track Designation, Breakthrough
Therapy Designation, a Special Protocol Agreement, and a Biomarker
Letter of Support from the FDA for Bipolar Depression with
Suicidality. NRX-101 is further being developed for chronic
pain and PTSD.
Up to 50% of individuals with bipolar disorder attempt suicide
over their lifetime, and estimates indicate that up to 20% may die
by suicide. The only FDA-approved treatment for patients with
suicidal bipolar depression remains electroconvulsive therapy.
Conventional antidepressants can increase the risk of suicide in
certain patients; hence their labels contain a warning to that
effect. NRX-101 is a patented, oral, fixed dose combination of
D-cycloserine and lurasidone, neither of which has shown addiction
potential in preclinical models. Based on the results of the
STABIL-B trial, NRX-101 received Breakthrough Therapy Designation
from the FDA for the treatment of patients with severe bipolar
depression and acute suicidality after initial stabilization with
ketamine or other effective therapy.
NRX-101 is one of the first oral antidepressants currently in
late-stage clinical studies targeting the NMDA-receptor in the
brain, which represents potentially a key new mechanism to treat
depression with and without suicidality, as well as chronic pain,
PTSD and other indications.
About NRx Pharmaceuticals
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.
Cautionary Note Regarding Forward-Looking Statements
This announcement of NRx Pharmaceuticals, Inc. includes
"forward-looking statements" within the meaning of the "safe
harbor" provisions of the U.S. Private Securities Litigation Reform
Act of 1995, which may include, but are not limited to, statements
regarding our financial outlook, product development, business
prospects, and market and industry trends and conditions, as well
as the Company's strategies, plans, objectives, and goals. These
forward-looking statements are based on current beliefs,
expectations, estimates, forecasts, and projections of, as well as
assumptions made by, and information currently available to, the
Company's management.
The Company assumes no obligation to revise any forward-looking
statement, whether as a result of new information, future events or
otherwise. Accordingly, you should not place reliance on any
forward-looking statement, and all forward-looking statements are
herein qualified by reference to the cautionary statements set
forth above.
NRX PHARMACEUTICALS,
INC.
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands, except share
and per share data)
|
|
|
|
|
|
September 30,
2023
|
|
December 31,
2022
|
|
|
(Unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
8,902
|
|
$
|
20,054
|
Prepaid expenses and
other current assets
|
|
|
4,187
|
|
|
5,741
|
Total current
assets
|
|
|
13,089
|
|
|
25,795
|
Other assets
|
|
|
21
|
|
|
21
|
Total
assets
|
|
$
|
13,110
|
|
$
|
25,816
|
LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
3,631
|
|
$
|
2,076
|
Accrued and other
current liabilities
|
|
|
4,728
|
|
|
4,855
|
Accrued clinical site
costs
|
|
|
575
|
|
|
914
|
Convertible note
payable and accrued interest – short term
|
|
|
10,069
|
|
|
7,703
|
D&O insurance
payable
|
|
|
314
|
|
|
—
|
Warrant
liabilities
|
|
|
10
|
|
|
37
|
Total current
liabilities
|
|
|
19,327
|
|
|
15,585
|
Convertible note
payable and accrued interest – long term
|
|
|
—
|
|
|
2,822
|
Total
liabilities
|
|
$
|
19,327
|
|
$
|
18,407
|
|
|
|
|
|
|
|
Preferred stock, $0.001
par value, 50,000,000 shares authorized;
|
|
|
—
|
|
|
—
|
Series A convertible
preferred stock, $0.001 par value, 12,000,000
shares authorized; 3,000,000 and 0 shares issued and outstanding
at
September 30, 2023 and December 31, 2022,
respectively
|
|
|
3
|
|
|
—
|
Common stock, $0.001
par value, 500,000,000 shares authorized;
83,919,554 and 66,442,989 shares issued and outstanding at
September
30, 2023 and December 31, 2022, respectively
|
|
|
84
|
|
|
67
|
Additional paid-in
capital
|
|
|
242,533
|
|
|
230,339
|
Accumulated other
comprehensive loss
|
|
|
(22)
|
|
|
—
|
Accumulated
deficit
|
|
|
(248,815)
|
|
|
(222,997)
|
Total stockholders'
(deficit) equity
|
|
|
(6,217)
|
|
|
7,409
|
Total liabilities and
stockholders' (deficit) equity
|
|
$
|
13,110
|
|
$
|
25,816
|
NRX PHARMACEUTICALS,
INC.
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS (in thousands, except share and per share
data)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
3,314
|
|
$
|
4,129
|
|
$
|
10,837
|
|
$
|
12,571
|
General and
administrative
|
|
|
2,494
|
|
|
5,012
|
|
|
12,344
|
|
|
21,876
|
Settlement
expense
|
|
|
—
|
|
|
—
|
|
|
250
|
|
|
—
|
Total operating
expenses
|
|
|
5,808
|
|
|
9,141
|
|
|
23,431
|
|
|
34,447
|
Loss from
operations
|
|
|
(5,808)
|
|
|
(9,141)
|
|
|
(23,431)
|
|
|
(34,447)
|
Other (income)
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
(119)
|
|
|
(95)
|
|
|
(420)
|
|
|
(119)
|
Interest
expense
|
|
|
40
|
|
|
—
|
|
|
40
|
|
|
3
|
Change in fair value
of convertible note payable
|
|
|
359
|
|
|
—
|
|
|
2,794
|
|
|
—
|
Change in fair value
of warrant liabilities
|
|
|
(26)
|
|
|
37
|
|
|
(27)
|
|
|
(236)
|
Change in fair value
of Earnout Cash liability
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,582)
|
Total other (income)
expenses
|
|
|
254
|
|
|
(58)
|
|
|
2,387
|
|
|
(4,934)
|
Net loss
|
|
$
|
(6,062)
|
|
$
|
(9,083)
|
|
$
|
(25,818)
|
|
$
|
(29,513)
|
Change in fair value of
convertible note attributed to
credit risk
|
|
|
—
|
|
|
—
|
|
|
22
|
|
|
—
|
Other comprehensive
loss
|
|
|
—
|
|
|
—
|
|
|
22
|
|
|
—
|
Comprehensive
loss
|
|
$
|
(6,062)
|
|
$
|
(9,083)
|
|
$
|
(25,840)
|
|
$
|
(29,513)
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.07)
|
|
$
|
(0.14)
|
|
$
|
(0.35)
|
|
$
|
(0.45)
|
Weighted average common
shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
81,946,957
|
|
|
66,449,593
|
|
|
74,114,180
|
|
|
65,532,409
|
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SOURCE NRx Pharma