Full Press Release Details
NRx Pharmaceuticals Reports Third Quarter 2023
Financial Results and Provides Business Update
Four near-term milestones, including initiation
of potential spinout initiatives
expected in 2023/early 2024
RADNOR, Pa., November 13,
2023 - 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.
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.
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
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
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
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
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.
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.
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.
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