RADNOR,
Pa., Dec. 2, 2022 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals",
the "Company"), a clinical-stage biopharmaceutical company, today
announced it received written notice on December 1, 2022 from The Nasdaq Stock Market
informing NRx Pharmaceuticals that it has regained compliance with
the minimum bid price requirement under the Nasdaq Listing Rule
5450(a)(1) (which requires the Company to maintain a minimum
closing bid price of $1.00 per share)
and the matter is now closed. Nasdaq staff made this determination
after NRx Pharmaceuticals' closing bid price was above $1.00 per share for 10 consecutive business days
from November 16, 2022, to November
30, 2022.
About NRX-101
NRx Pharmaceuticals Regains Nasdaq Listing
Compliance Status According to Notice
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. 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.
NRx Pharmaceuticals expects to begin its registration trial for
NRX-101 under a SPA in 4Q 2022 or early Q1 2023.
About NRx
Pharmaceuticals
NRx Pharmaceuticals is a 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 a Food and Drug
Administration ("FDA") Special Protocol Agreement and Breakthrough
Therapy Designation in patients with bipolar depression and acute
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, potentially 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.
CORPORATE CONTACT
Molly Cogan
Sr. Director, Global Communications
mcogan@nrxpharma.com
INVESTOR RELATIONS
Suzanne Messere
Investor
Relations
suzanne.messere@sternir.com
NRX PHARMACEUTICALS,
INC
CONDENSED CONSOLIDATED
BALANCE SHEETS
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2022
|
|
|
December 31,
2021
|
|
|
(Unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
18,249
|
|
$
|
27,605
|
Prepaid expenses and
other current assets
|
|
|
6,552
|
|
|
5,109
|
Total current
assets
|
|
|
24,801
|
|
|
32,714
|
Other assets
|
|
|
23
|
|
|
15
|
Total
assets
|
|
$
|
24,824
|
|
$
|
32,729
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,168
|
|
$
|
3,687
|
Accrued and other
current liabilities
|
|
|
5,067
|
|
|
2,375
|
Accrued clinical site
costs
|
|
|
751
|
|
|
469
|
Earnout Cash
liability
|
|
|
—
|
|
|
4,582
|
Warrant
liabilities
|
|
|
56
|
|
|
292
|
Note payable and
accrued interest
|
|
|
—
|
|
|
518
|
Total
liabilities
|
|
$
|
8,042
|
|
$
|
11,923
|
|
|
|
|
|
|
|
Preferred stock, $0.001
par value, 50,000,000 shares authorized; 0
shares issued and outstanding at September 30, 2022 and
December
31, 2021, respectively
|
|
|
—
|
|
|
—
|
Common stock, $0.001
par value, 500,000,000 shares authorized;
67,641,314 and 58,810,550 shares issued and outstanding at
September
30, 2022 and December 31, 2021, respectively
|
|
|
68
|
|
|
59
|
Additional paid-in
capital
|
|
|
229,470
|
|
|
203,990
|
Accumulated
deficit
|
|
|
(212,756)
|
|
|
(183,243)
|
Total stockholders'
equity
|
|
|
16,782
|
|
|
20,806
|
Total liabilities and
stockholders' equity
|
|
$
|
24,824
|
|
$
|
32,729
|
|
The accompanying notes
are an integral part of these unaudited condensed consolidated
financial statements.
|
NRX PHARMACEUTICALS,
INC
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
4,129
|
|
$
|
6,276
|
|
$
|
12,571
|
|
$
|
13,844
|
General and
administrative
|
|
|
5,012
|
|
|
13,823
|
|
|
21,876
|
|
|
28,382
|
Settlement
expense
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
21,366
|
Reimbursement of
expenses from Relief Therapeutics
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(771)
|
Total operating
expenses
|
|
|
9,141
|
|
|
20,099
|
|
|
34,447
|
|
|
62,821
|
Loss from
operations
|
|
|
(9,141)
|
|
|
(20,099)
|
|
|
(34,447)
|
|
|
(62,821)
|
Other (income)
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on extinguishment
of debt
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(121)
|
Interest
income
|
|
|
(95)
|
|
|
—
|
|
|
(119)
|
|
|
—
|
Interest
expense
|
|
|
—
|
|
|
5
|
|
|
3
|
|
|
16
|
Change in fair value
of warrant liabilities
|
|
|
37
|
|
|
16,537
|
|
|
(236)
|
|
|
(823)
|
Change in fair value
of Earnout Cash liability
|
|
|
—
|
|
|
408
|
|
|
(4,582)
|
|
|
763
|
Total other (income)
expenses
|
|
|
(58)
|
|
|
16,950
|
|
|
(4,934)
|
|
|
(165)
|
Net loss
|
|
|
(9,083)
|
|
|
(37,049)
|
|
|
(29,513)
|
|
|
(62,656)
|
Deemed
dividend
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(255,822)
|
Net loss attributable
to common stockholders
|
|
$
|
(9,083)
|
|
$
|
(37,049)
|
|
$
|
(29,513)
|
|
$
|
(318,478)
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.14)
|
|
$
|
(0.72)
|
|
$
|
(0.45)
|
|
$
|
(1.45)
|
Diluted
|
|
$
|
(0.14)
|
|
$
|
(0.72)
|
|
$
|
(0.45)
|
|
$
|
(1.45)
|
Net loss per share
attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.14)
|
|
$
|
(0.72)
|
|
$
|
(0.45)
|
|
$
|
(7.36)
|
Diluted
|
|
$
|
(0.14)
|
|
$
|
(0.72)
|
|
$
|
(0.45)
|
|
$
|
(7.36)
|
Weighted average common
shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
66,449,593
|
|
|
51,739,452
|
|
|
65,532,409
|
|
|
43,290,675
|
|
The accompanying notes
are an integral part of these unaudited condensed consolidated
financial statements.
|
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SOURCE NRx Pharmaceuticals, Inc.