- Over the past 12 months, the Company reinitiated its psychiatry
development program post pandemic, transferred manufacturing of
NRX-101 to the US, and initiated a clinical trial in suicidal
treatment-resistant bipolar depression, which was recently reviewed
by the independent Data Safety Monitoring Board (DSMB)
- The DSMB identified no safety or futility signals in the first
50 patients with Suicidal Treatment-Resistant Bipolar Depression
enrolled in the trial; enrollment to continue as planned
- The current trial has been upgraded to a Phase 2b/3 study that may be used for a registrational
filing; on track to report topline clinical data in 4Q 2023
- Initiated registrational Phase 3 clinical trial of NRX-101 in
patients with bipolar depression with acute suicidal ideation and
behavior (ASIB) and held Type B meeting with U.S. FDA in 1Q 2023,
which provided important input to the NRX-101 program
- Ended 2022 with $20.1 million in
cash and cash equivalents and announced subsequent $2.9 million registered direct offering in
March 2023 to support pipeline of
life-saving therapeutics.
- Two international leaders in Psychiatry, Prof. Andrew Nierenberg of Harvard Medical School and Prof. Marion Leboyer, of INSERM, Paris have joined the NRx Advisory Board
RADNOR,
Pa., March 30, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced its financial results for the full year 2022 and provided
a business and clinical update.
NRx Pharmaceuticals Reports Full Year 2022
Financial Results and Provides Business Update
"2022 was an exciting year of continued execution for NRx
Pharmaceuticals as we reinitiated our psychiatry drug development
program post-pandemic and advanced clinical development for our
lead investigational compound, NRX-101, in Suicidal
Treatment-Resistant Bipolar Depression," said Stephen Willard, J.D., Chief Executive Officer
and Director of NRx Pharmaceuticals. "We are delighted to augment
our advisory board with two world-class leaders in psychiatry,
Professors Andrew Nierenberg of
Harvard Medical School, and
Marion Leboyer of INSERM, one of
France's leading universities.
Prof. Nierenberg also serves as Principal Investigator of our
ongoing Clinical Trials. The first few months of 2023 have been
particularly productive. We initiated a Phase 3 registrational
clinical trial for NRX-101 in patients suffering from severe
bipolar depression with acute suicidality and received an
encouraging DSMB readout for a second trial in the far broader
indication of Suicidal Treatment-Resistant Bipolar Depression. We
are following guidance from FDA to broaden the indication for our
medicine to the large population of patients treated in the
outpatient setting who do not require acute stabilization with
ketamine. Of note, with this guidance, we believe the design
of this study has effectively converged with our ongoing Phase
2b/3 outpatient trial. This is
the first time, to our knowledge, that patients with suicidal
ideation have been welcomed in a clinical trial of an oral
antidepressant. Currently, the only approved treatment for patients
with suicidality in depression is electroshock therapy, with its
known complications.
"It is an exciting time to be a part of NRx Pharmaceuticals as
we look ahead to multiple near-term catalysts on track for 2023 and
2024. Based on our newly-completed US-based manufacture of phase 3
scale medication using the expected commercial process, we have
upgraded our outpatient trial to a phase 2b/3 study that may be used for registrational
purposes, should it demonstrate safety and efficacy. We look
forward to topline clinical data from this trial by the first
quarter of 2024. We are also initiating an Expanded Access Program
for NRX-101 to serve patients who have exhausted approved medicines
for bipolar depression and to build the safety database requested
by the FDA as part of the enlarged outpatient indication they
recommended in our recent Type B meeting. As we continue to
progress our portfolio of potentially life-saving therapeutics in a
turbulent macroeconomic market, we are well-positioned following
our registered direct offering to continue to advance our mission
of meeting the needs of underserved patients with serious CNS
disorders."
NRX-101 is a fixed dose combination of D-cycloserine, an NMDA
antagonist, and lurasidone, a 5HT2a atypical antipsychotic and
antidepressant, under investigation for the treatment
of Suicidal Treatment-Resistant Bipolar Depression .
Fourth Quarter and Recent Clinical and Regulatory
Highlights
NRX-101 Lead Indication – Acute Suicidal Ideation and Behavior
(ASIB)
- In January 2023, the Company
initiated a Phase 3 registrational clinical trial of NRX-101 for
the treatment of severe bipolar depression with acute suicidal
ideation and behavior (SBD-ASIB). The trial is a double-blind,
adaptive trial with a 2:1 randomization favoring NRX-101 vs.
lurasidone alone. The study is seeking to prove that following a
successful response to a single infusion of ketamine (NRX-100),
treatment with NRX-101 is superior to lurasidone in maintaining
improvement in symptoms of depression as measured by the MADRS-10
total score. Based on Phase 2 STABIL-B findings, the FDA granted
Breakthrough Therapy Designation (BTD) and a Special Protocol
Agreement (SPA) for NRX-101 in SBD-ASIB. The BTD allows for an
expedited rolling submission of a new drug application (NDA) for
investigational drugs that have demonstrated substantial
improvement over existing approved therapies, and the SPA allows
for a single registrational trial of NRX-101 in SBD-ASIB after
stabilization with ketamine, using a protocol similar to the
STABIL-B trial with a patient population of less than 100.
- In January 2023, the Company
reported that it reached alignment with the FDA on its proposed
registration manufacturing plan for the Phase 3 trial of NRX-101 in
SBD-ASIB. As previously announced in October
2022, NRx received a request from the FDA for Type C
guidance on the chemistry, manufacturing and controls (CMC) aspects
of the NRX-101 program, and the Company submitted an updated
NRX-101 module 3 to add the intended commercial stage manufacturing
process for drug product in the Phase 3 registrational clinical
trial.
- In January 2023, NRx held a Type
B meeting with the FDA's Psychiatry Division to align on the
registration strategy for NRX-101 and liaise on its intended
indication, which initially was for the treatment of adults with
SBD-ASIB. In addition to reaffirming NRX-101's SPA, which was
originally granted in April 2019, the
FDA suggested that NRX-101's clinical development program be
enlarged to allow for the treatment of patients with bipolar
depression and suicidality in the outpatient setting. This
recommendation was consistent with the NRX-101_003 trial (NCT
03395392) and addresses a population believed to encompass
approximately 1 million Americans with suicidal treatment-resistant
bipolar depression for whom there is no approved drug. In
recommending that the Company pursue this larger indication, FDA
identified the need for a safety database of 1,500 patients. The
Company is initiating an Expanded Access Program to both serve the
needs of patients who have exhausted approved medicines for bipolar
depression and to build that safety database.
NRX-101 Indication – Suicidal Treatment-Resistant Bipolar
Depression (formerly Sub-acute Suicidal Ideation and Behavior
(SSIB)
- In March 2023, NRx reported that
the DSMB examined unblinded study data to assess the study for
safety and potential futility., The DSMB recommended continuation
of patient enrollment as planned. As defined in the study's
Statistical Analysis Plan, in order to determine non-futility and
to recommend further enrollment, the DSMB must identify a potential
(though not yet statistically-significant) advantage of NRX-101 vs.
the lurasidone comparator. The DSMB further identified no safety
concerns.
- The Phase 2b/3 double-blind study
aims to demonstrate reduction in depression and suicidal ideation
over six weeks, which is the standard time frame for oral
antidepressant medicines. With the upgrading of this trial to a
phase 2b/3 trial which may be used
for registrational purposes. This patient population could
represent up to 1 million bipolar depression patients in the US and
represents a portion of the indication expansion recommended in
recent correspondence with the FDA
Consolidated NRX-101 Program in Suicidal Treatment-Resistant
Bipolar Depression
- Based on the comments and guidance from the FDA in its recent
Type B meeting regarding the registrational Acute Suicidality trial
and a potentially broader indication, as well as the guidance it
received from the DSMB regarding the ongoing Phase IIb/3 clinical
study of NRX-101 for the treatment of severe bipolar depression in
patients with SSIB, the Company is evaluating changes to its
registrational program for NRX-101 and will seek to consolidate
patients originally expected to enroll in the in the ASIB study
into the currently enrolling Phase 2b/3 trial. This would potentially allow
registration of NRX-101 for Suicidal Treatment-Resistant Bipolar
Depression, regardless of the mechanism of stabilization. With the
FDA's guidance to enroll patients for the acute (SPA) study in the
outpatient setting only after stabilization, the design of this
trial has effectively converged with the currently enrolling phase
IIb/3 trial; patients within both groups are deemed to have
treatment resistant bipolar depression with suicidality. This
broader indication may also offer significant advantages in
commercialization, while negating the need for a separate NDA for
ketamine in Suicidal stabilization. Data are expected by 4Q
2023.
NRX-101 Indication – Post Traumatic Stress Disorder (PTSD)
- In September 2022, NRx announced
plans to investigate PTSD as an additional indication. The Company
expects to commence Phase 2 clinical trial planning of NRX-101 in
PTSD in 2Q 2023.
- Depression in PTSD may be driven by pathways that are similar
to those that drive depression in other conditions (NMDA and
5-HT2A). Additionally, approximately 10% of patients with PTSD may
experience suicidality, especially those with severe PTSD.
- In a preclinical PTSD study, D-cycloserine, a component of
NRX-101, demonstrated the ability to extinguish recurring images of
traumatic events, also known as fear memory, in a validated WKY
model of PTSD. Ketamine has demonstrated an effect on this
debilitating symptom of PTSD. Should NRX-101 have a similar
beneficial effect, it has the potential to be the first labeled
medicine for PTSD symptoms.
Corporate Updates
- In December 2022, NRx
Pharmaceuticals and Relief Therapeutics announced the close of
their definitive settlement agreements to resolve and dismiss their
pending litigation. Per the terms of the settlement, NRx
Pharmaceuticals transferred all of the assets it used in the NRx
aviptadil development program to Relief Therapeutics, including the
regulatory filings, patent applications, clinical data and the
formulation of the aviptadil product it was previously developing.
Relief Therapeutics now has the exclusive right and control going
forward, with the obligation to use commercially reasonable efforts
to develop and commercialize an aviptadil product. Pending
commercial approval of an aviptadil product (whether for COVID-19
or any other indication), Relief will pay NRx Pharmaceuticals
milestone payments and royalties based on a percentage of future
sales of an aviptadil product, up to a maximum of $30 million in royalties in the aggregate.
- In February 2023, the Company
received notice of the issuance of a U.S. patent covering the lead
formulation, NRX-101, a glycine site NMDA antagonist in clinical
trials to treat bipolar depression with acute and subacute
suicidality. This new patent covers the use of NRX-101 to treat
patients suffering from depression, including bipolar depression or
major depression (MDD) with or without suicidality and strengthens
the Company's intellectual property position until at least
2033.
- In March 2023, the Company
announced the close of a $2.9 million
registered direct offering. Participants were existing investors,
and the Company anticipates using the proceeds to initiate its
national treatment protocol and safety database for NRX-101 for
treatment-resistant bipolar depression with risk of self-harm under
an FDA expanded access protocol, and to advance its pipeline of
life-saving therapeutics.
Financial Results for Twelve Months ended December 31, 2022
- For the year ended December 31,
2022, NRx Pharmaceuticals recorded $17.0 million of research and development
expenses compared to $20.3 million
for the year ended December 31, 2021.
The decrease of $3.2 million is
related primarily to a decrease of $2.5
million in clinical trials and development expenses related
to ZYESAMI, $0.7 million in
stock-based compensation expense, $0.8
million related to fees paid to regulatory and process
development consultants, partially offset by an increase of
$0.5 in other regulatory and process
development costs and $0.3 million in
shipping, freight, and delivery costs. The $17.0 million and $20.3
million of research and development expenses for the years
ended December 31, 2022 and 2021,
respectively, include $0.6 million
and $1.3 million, respectively, of
non-cash stock-based compensation.
- For the year ended December 31,
2022, NRx Pharmaceuticals recorded $27.4 million of general and administrative
expenses compared to $74.9 million
for the year ended December 31, 2021.
The decrease of $47.6 million was
primarily, related to a decrease of $53.3
million in consultant fees, of which $41.0 million related to the fair value of common
stock issued and $4.8 million related
to the fair value of the 200,000 shares of Common Stock issued and
$3.4 million in stock-based
compensation expense, partially offset by an increase of
$3.7 million in insurance expenses,
$3.4 million in legal, professional
and accounting fees, $1.5 million in
employee expenses, and $0.5 million
in other general and administrative expenses. The $27.4 million and $74.9
million of general and administrative expenses for the years
ended December 31, 2022 and 2021,
respectively, include $3.1 million
and $60.3 million, respectively, of
non-cash stock-based compensation.
- Net loss for the twelve months ended December 31, 2022, was $39.8 million compared with a net loss of
$93.1 million for the twelve months
ended December 31, 2021.
- As of December 31, 2022, the cash
balance was $20.1 million compared to
$27.6 million as of December 31, 2021.
- On March 8, 2023, NRx
Pharmaceuticals entered into a securities purchase agreement with
accredited investors (the "Investors"), providing for the issuance
and sale of 3,866,666 shares of the Company's common stock ("Common
Stock") and warrants to purchase up to 3,866,666 shares of Common
Stock (the "Investor Warrants") in a registered direct offering
priced at-the-market under Nasdaq rules for a purchase price of
$0.75 per share (the "Offering"). The
Investors have agreed not to transfer the Common Stock for six
months following the date hereof. The Investor Warrants will have
an exercise price of $0.75 per share,
will be initially exercisable beginning six months following the
date of issuance (the "Initial Exercise Date") and will expire 5
years from the Initial Exercise Date. The aggregate gross proceeds
to the Company from the Offering are expected to be approximately
$2.9 million. The Company intends to
use the net proceeds from such offering for working capital and
general corporate purposes. The closing of the sale of these
securities occurred on March 9,
2023.
Conference Call and Webcast Details
A live webcast of the conference call will be available on the
Company's website
at https://ir.nrxpharma.com/news-events/ir-calendar. 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
Up to 50% of individuals with bipolar disorder attempt suicide
over their lifetime, and estimates indicate that up to 20% may
succumb to suicide. The only FDA-approved treatment for patients
with bipolar depression and acute suicidal ideation & behavior
(ASIB) remains electroconvulsive therapy (ECT).
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 a Phase 2
proof-of-concept study, NRX-101 received Breakthrough Therapy
Designation from the FDA for the treatment of severe bipolar
depression in patients with ASIB 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 PTSD and other
indications. To date, NRX-101 is the only oral NMDA investigational
medicine focused on bipolar depression in patients with acute and
sub-acute suicidality.
About NRx Pharmaceuticals
Clinical-stage biopharmaceutical company developing therapeutics
for the treatment of central nervous system disorders, specifically
suicidal depression and post-traumatic stress disorder (PTSD). The
company's lead program NRX-101, an oral, fixed-dose combination of
D-cycloserine and lurasidone, targets the brain's NMDA receptor and
is being investigated in a Phase 3 trial under an FDA Special
Protocol Agreement and Breakthrough Therapy Designation in patients
with bipolar depression and suicidal ideation, an indication for
which the only approved treatment is electroshock therapy. NRx
Pharmaceuticals has also initiated a Phase 2b clinical trial in patients with Sub-Acute
Suicidality, a substantially broader indication. The Breakthrough
Therapy Designation and Special Protocol Agreement were awarded by
the FDA based on the Company's prior STABIL-B trial that
demonstrated substantial improvement over available therapy in
reducing depression and suicidality compared to placebo when
patients were treated with NRX-101 after a single dose of
ketamine.
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.
|
|
CONSOLIDATED BALANCE
SHEETS
|
(in thousands,
except share and per share data)
|
|
|
|
December 31,
|
|
|
2022
|
|
2021
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
20,054
|
|
$
|
27,605
|
Prepaid expenses and
other current assets
|
|
|
5,741
|
|
|
5,109
|
Total current
assets
|
|
|
25,795
|
|
|
32,714
|
Other assets
|
|
|
21
|
|
|
15
|
Total
assets
|
|
$
|
25,816
|
|
$
|
32,729
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,076
|
|
$
|
3,687
|
Accrued and other
current liabilities
|
|
|
4,855
|
|
|
2,375
|
Accrued clinical site
costs
|
|
|
914
|
|
|
469
|
Earnout Cash
liability
|
|
|
—
|
|
|
4,582
|
Convertible note
payable and accrued interest - short term
|
|
|
8,703
|
|
|
—
|
Warrant
liabilities
|
|
|
37
|
|
|
292
|
Note payable and
accrued interest
|
|
|
—
|
|
|
518
|
Total current
liabilities
|
|
|
16,585
|
|
|
11,923
|
Convertible note
payable and accrued interest - long term
|
|
|
1,822
|
|
|
—
|
Total
liabilities
|
|
$
|
18,407
|
|
$
|
11,923
|
|
|
|
|
|
|
|
Preferred stock, $0.001
par value, 50,000,000 shares authorized; 0 shares
issued and outstanding at December 31, 2022 and December 31,
2021,
respectively
|
|
|
—
|
|
|
—
|
Common stock, $0.001
par value, 500,000,000 shares authorized;
66,442,989 and 58,810,550 shares issued and outstanding at
December
31, 2022 and 2021, respectively
|
|
|
67
|
|
|
59
|
Additional paid-in
capital
|
|
|
230,401
|
|
|
203,990
|
Accumulated
deficit
|
|
|
(223,059)
|
|
|
(183,243)
|
Total stockholders'
equity
|
|
|
7,409
|
|
|
20,806
|
Total liabilities and
stockholders' equity
|
|
$
|
25,816
|
|
$
|
32,729
|
NRX PHARMACEUTICALS,
INC.
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
(in thousands,
except share and per share data)
|
|
|
|
Year ended
|
|
|
December 31,
|
|
|
2022
|
|
2021
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
17,027
|
|
$
|
20,257
|
General and
administrative
|
|
|
27,370
|
|
|
74,944
|
Settlement
expense
|
|
|
—
|
|
|
21,366
|
Reimbursement of
expenses from Relief Therapeutics
|
|
|
—
|
|
|
(771)
|
Total operating
expenses
|
|
|
44,397
|
|
|
115,796
|
Loss from
operations
|
|
|
(44,397)
|
|
|
(115,796)
|
Other (income)
expenses:
|
|
|
|
|
|
|
Gain on extinguishment
of debt
|
|
|
—
|
|
|
(121)
|
Interest
income
|
|
|
(249)
|
|
|
—
|
Interest
expense
|
|
|
—
|
|
|
18
|
Change in fair value
of convertible note payable
|
|
|
505
|
|
|
—
|
Change in fair value
of warrant liabilities
|
|
|
(255)
|
|
|
(1,692)
|
Change in fair value
of Earnout Cash liability
|
|
|
(4,582)
|
|
|
(20,938)
|
Total other (income)
expenses
|
|
|
(4,581)
|
|
|
(22,733)
|
Loss before
tax
|
|
|
(39,816)
|
|
|
(93,063)
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
Net loss
|
|
|
(39,816)
|
|
|
(93,063)
|
Deemed
dividend
|
|
|
—
|
|
|
(255,822)
|
Net loss attributable
to common stockholders
|
|
$
|
(39,816)
|
|
$
|
(348,885)
|
Net loss per
share:
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.61)
|
|
$
|
(1.98)
|
Diluted
|
|
$
|
(0.61)
|
|
$
|
(1.98)
|
Net loss per share
attributable to common stockholders:
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.61)
|
|
$
|
(7.44)
|
Diluted
|
|
$
|
(0.61)
|
|
$
|
(7.44)
|
Weighted average common
shares outstanding:
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
65,766,786
|
|
|
46,917,701
|
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SOURCE NRx Pharmaceuticals, Inc.