- Enrollment continues in the Phase 2b/3 clinical trial evaluating NRX-101 in
Suicidal Treatment-Resistant Bipolar Depression; data expected in
4Q 2023
- National educational campaign launched to further accelerate
enrollment in
- Breakthrough Therapy Designation meeting for NRX-101 in
Suicidal Treatment-Resistant Bipolar Depression with the U.S. FDA
planned for 2Q 2023; on track to report topline clinical data in 4Q
2023
- Ended quarter with $16.5 million
in cash and cash equivalents
- Management to host a conference call and webcast today at
8:30 a.m. ET
RADNOR,
Pa., May 16, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced its financial results for the first quarter of 2023 and
provided a business update.
"In the U.S. alone, nearly one million people suffer from
Suicidal Treatment-Resistant Bipolar Depression, a lethal condition
that ultimately leads to a suicide attempt in half of this patient
population. Currently, there is no approved medicine for patients
with this condition, and the only FDA-approved treatment is
electroshock therapy, which has numerous known side-effects," said
Stephen Willard, J.D., Chief
Executive Officer and Director of NRx Pharmaceuticals. "We are
committed to demonstrating the therapeutic benefit of NRX-101, the
first oral NMDA-targeted medicine to be developed for patients with
suicidal bipolar depression, for these patients facing significant
unmet need, and we remain on track to report initial data from this
integrated trial in the fourth quarter of this year. We look
forward to working with the U.S. FDA on the upgraded Phase
2b/3 trial of NRX-101 in the broader
indication of Suicidal Treatment-Resistant Bipolar Depression
during a Breakthrough Therapy Designation meeting later this
quarter."
First Quarter Clinical and Regulatory Highlights
NRX Pharma is engaged in the development of NRX-101, a fixed
dose combination of D-cycloserine and lurasidone for the treatment
of suicidal bipolar depression and potentially for other future
indications. NRX-101 has been granted Fast Track Designation,
Breakthrough Therapy Designation, a Special Protocol Agreement, and
a Biomarker Letter of Support by the US Food and Drug
Administration (FDA). In Q1 2023 the Company met with the FDA and
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. These patients are the current target
population of the ongoing clinical trial.
Based on the guidance of 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 Company is
engaged in that ongoing clinical trial of NRX-101 vs. lurasidone in
patients with treatment-resistant bipolar depression with the
objective of demonstrating a decreased in depression scores and
scores of suicidal ideation in patients treated with NRX-101
compared to those treated with lurasidone alone.
The clinical trial was originally begun as an exploratory study
in Q2 2022, as disclosed in prior filings. In Q1 2023 the study's
independent Data Safety Monitoring Board (DSMB) reviewed both
safety and unblinded efficacy data for the first 50 patients in the
clinical trial and advised the Company that no safety concerns were
identified. Moreover, the DSMB did not identify a futility signal,
suggesting that the trial has potential to demonstrate a
statistically significant outcome with additional enrollment. On
this basis, the DSMB advised management to continue enrolling study
participants.
During the first quarter of 2023, the Company refined its
ability to validate the psychometric ratings that are used to
assess the efficacy endpoints for the clinical trial. The Company
relies upon a team of veteran raters who both train independent
site rates and monitor the technical quality of each rating. A
standard was set of 90% or better concordance between the Company's
veteran rating team and site raters. This standard was met for all
study participants whose ratings were obtained in their primary
language and management believes that this standard can be
maintained for the duration of the trial.
In April 2023, the Company
contracted with 1nHealth to initiate a recruitment campaign that
may cover up to 45 states in the US to recruit sufficient
participants for this enlarged trial. The Company has similarly
broadened its previously disclosed 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 a
voice-of-the-patient organization with national reach to publicize
the clinical trial to the 400,000+ subscribers who have indicated a
focus on bipolar depression and suicidality.
In Q1 2023, the Company announced the participation of Prof.
Andrew Nierenberg, M.D., Head of the
Massachusetts General Hospital (MGH) Dauton Family Center for
Bipolar Treatment Innovation as the Principal Investigator of the
clinical trial. The Company has now initiated clinical trial sites
at Northwestern University
(Chicago) and University of Texas, Austin, in addition to
commercial research sites.
NRX-101 Indication – Post Traumatic Stress Disorder (PTSD)
- NRx plans to investigate NRX-101 in PTSD as an additional
indication. The Company expects to commence planning for a Phase 2
clinical trial in the second quarter of 2023 with the study
expected to be open for enrollment in 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.
First Quarter Corporate Updates
- 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.
- The Company has continued to engage in a strategic conversation
focused on funding the drug approval and commercialization. In
parallel, the Company has established an ongoing dialogue with
Streeterville Capital LLC, the Company's current debt lender, to
modify the Company's current debt facility to best support the
ongoing needs of the clinical trial.
Financial Results for the First Quarter Ended March 31, 2023
- For the three months ended March 31,
2023, NRx Pharmaceuticals recorded $3.7 million of research and development expenses
compared to $5.5 million for the year
ended March 31, 2022. The decrease of
$1.8 million is related primarily to
a decrease of $1.8 million in
clinical trials and development expenses related to ZYESAMI.
- For the three months ended March 31,
2023, NRx Pharmaceuticals recorded $5.8 million of general and administrative
expenses compared to $10.2 million
for the three months ended March 31,
2022. The decrease of $4.4
million was primarily, related to a decrease of $3.9 million in legal, professional and
accounting fees, $0.6 million in
insurance expenses, $0.5 million in
stock-based compensation expense, partially offset by $0.3 million in employee expenses and
$0.2 million in consultant fees.
- Assuming future debt payments can continue to be made in stock,
the $16.5 million of cash and cash
equivalents at the end of the first quarter of 2023 is expected to
fund the Company's operations through the expected delivery of data
in our Phase 2b/3 trial.
Additionally, we are evaluating operational efficiencies associated
with the completion of manufacturing activities to extend this
runway.
Conference Call and Webcast Details
A live webcast of the conference call will be available on the
Company's website today at 8:30 a.m.
ET,
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 treatment-resistant 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 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
NRx Pharmaceuticals is a clinical -stage biopharmaceutical
company developing therapeutics for the treatment of central
nervous system disorders, specifically bipolar depression with
suicidality 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
N-methyl-D-aspartate (NMDA) receptor and is being investigated in a
Phase 2b/3 clinical trial for
Suicidal Treatment-Resistant Bipolar Depression, which includes
patients with both acute and sub-acute suicidality, an indication
for which the only approved treatment is electroshock therapy. The
company's prior Phase 2 STABIL-B clinical trial evaluating NRX-101
in patients with Severe Bipolar Depression with Acute Suicidal
Ideation & Behavior (ASIB) demonstrated a 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. Based on the findings from
the STABIL-B trial, the U.S. Food and Drug Administration (FDA)
granted a Special Protocol Agreement and Breakthrough Therapy
Designation for NRX-101 in patients with Severe Bipolar Depression
with ASIB.
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)
|
|
|
|
March 31,
2023
|
|
December 31,
2022
|
|
|
(Unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
16,506
|
|
$
|
20,054
|
Prepaid expenses and
other current assets
|
|
|
5,250
|
|
|
5,741
|
Total current
assets
|
|
|
21,756
|
|
|
25,795
|
Other assets
|
|
|
24
|
|
|
21
|
Total assets
|
|
$
|
21,780
|
|
$
|
25,816
|
LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
3,776
|
|
$
|
2,076
|
Accrued and other
current liabilities
|
|
|
5,054
|
|
|
4,855
|
Accrued clinical site
costs
|
|
|
1,020
|
|
|
914
|
Convertible note
payable and accrued interest - short term
|
|
|
12,189
|
|
|
7,703
|
Warrant
liabilities
|
|
|
25
|
|
|
37
|
Total current
liabilities
|
|
|
22,064
|
|
|
15,585
|
Convertible note
payable and accrued interest - long term
|
|
|
—
|
|
|
2,822
|
Total
liabilities
|
|
$
|
22,064
|
|
$
|
18,407
|
|
|
|
|
|
|
|
Preferred stock, $0.001
par value, 50,000,000 shares authorized; 0 shares
issued and outstanding at March 31, 2023 and December 31,
2022,
respectively
|
|
|
—
|
|
|
—
|
Common stock, $0.001
par value, 500,000,000 shares authorized;
70,309,655 and 66,442,989 shares issued and outstanding at March
31, 2023
and December 31, 2022, respectively
|
|
|
70
|
|
|
67
|
Additional paid-in
capital
|
|
|
233,576
|
|
|
230,339
|
Accumulated other
comprehensive income
|
|
|
106
|
|
|
—
|
Accumulated
deficit
|
|
|
(234,036)
|
|
|
(222,997)
|
Total stockholders'
(deficit) equity
|
|
|
(284)
|
|
|
7,409
|
Total liabilities and
stockholders' (deficit) equity
|
|
$
|
21,780
|
|
$
|
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
|
|
|
March 31,
|
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
3,650
|
|
$
|
5,483
|
General and
administrative
|
|
|
5,785
|
|
|
10,222
|
Total operating
expenses
|
|
|
9,435
|
|
|
15,705
|
Loss from
operations
|
|
|
(9,435)
|
|
|
(15,705)
|
Other (income)
expenses:
|
|
|
|
|
|
|
Interest
income
|
|
|
(156)
|
|
|
—
|
Interest
expense
|
|
|
—
|
|
|
3
|
Change in fair value of
convertible note payable
|
|
|
1,772
|
|
|
—
|
Change in fair value of
warrant liabilities
|
|
|
(12)
|
|
|
(157)
|
Change in fair value of
Earnout Cash liability
|
|
|
—
|
|
|
(2,103)
|
Total other (income)
expenses
|
|
|
1,604
|
|
|
(2,257)
|
Net loss
|
|
$
|
(11,039)
|
|
$
|
(13,448)
|
Change in fair value of
convertible note attributed to credit risk
|
|
|
(106)
|
|
|
—
|
Other comprehensive
income
|
|
|
(106)
|
|
|
—
|
Comprehensive
loss
|
|
$
|
(10,933)
|
|
$
|
(13,448)
|
Net loss per
share:
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.16)
|
|
$
|
(0.21)
|
Weighted average common
shares outstanding:
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
67,453,897
|
|
|
63,667,468
|
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SOURCE NRx Pharmaceuticals, Inc.