Q1 2022 NRX Pharmaceuticals Inc Earnings Call
And welcome to <unk> Pharmaceuticals, first quarter 2022 earnings conference call.
conference call.
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I would now like to turn the conference over to your host Tom Johnson from Investor Relations.
I would now like to turn a conference over to you host Tom Johnson from Invest Relations.
Sir Please go ahead.
Thank you operator before we proceed with the call I would like to remind everyone that certain statements made during this call are forward looking statements under U S Federal Securities law.
Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. Federal Security
These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.
Statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.
Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.
Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.
The forward-looking statements made during this call speak only as of date hereof, and the company undertakes no obligation to update or revise the forward-looking statement.
Forward looking statements made during this call speak only as the date hereof and the company undertakes no obligation to update or revise the forward looking statements.
Information presented on this call is contained in the press release issued earlier today and in the company's Form 10-Q that we're filing today, which may be accessed from the investors page of the NRX Pharmaceuticals website.
Information presented on this call is contained in the press release issued earlier today and in the company's Form 10-Q filing today, which wouldn't be accessed from the investors page of the interacts pharmaceuticals website.
Joining me on today's call from Enerex Pharmaceuticals are Robert Bestoff, Interim Chief Executive Officer, and Iris Drostmer, Chief Financial Officer and Treasurer. Robert will provide a summary of the company's progress before turning it over to Ira for a review of the company's financial results. Following their prepared remarks, the management team will address investor questions. And now I'll turn the call over to Robert.
Joining me on today's call from <unk> Pharmaceuticals, our Robert Best off interim Chief Executive Officer, and Aldo Strasbourg, Chief Financial Officer, and Treasurer, Robert will provide a summary of the company's progress strength before turning it over to IRA for a review of the company's financial results. Following their prepared remarks, the management team will address investor questions and now I'll turn the call over to <unk>.
Robert.
Thank you Tom Good morning, everyone and thank you for joining US today. We appreciate your attendance and look forward to summarizing our progress on our strategic priorities that are guiding our work in 2022, so let's begin.
Thank you, Tom. Good morning, everyone, and thank you for joining us today. We appreciate your attendance and look forward to summarizing our progress on our strategic priorities that are guiding our work in 2020.
So, let's begin. On our previous year-end earnings call, we announced our new strategic focus for 2022 by concentrating on our two late-stage drug candidates.
On our previous year end earnings call, we announced our new strategic focus for 2022 by concentrating on our two late stage drug candidates.
NRX 101 for the treatment of severe bipolar depression with acute and subacute suicidal ideation and behavior for which we have reactivated clinical trial development as part of our psychiatry portfolio.
Interacts one to one for the treatment of severe bipolar depression with acute and sub acute suites auto aviation and behavior for which we have reactivated clinical cloud development as part of our psychiatry portfolio.
in its intravenous formulation for the treatment of critical COVID-19 and potentially other respiratory diseases.
Hey, Sammy and its intravenous formulation for the treatment of critical COVID-19, potentially other respiratory diseases.
We believe these two drug candidates have shown solid scientific evidence to potentially help patients in these areas of very high unmet need and can serve as platforms for numerous indications in other respiratory and psychiatric conditions.
We believe these two drug candidates have shown solid scientific evidence to potentially help patients in these areas of very high unmet need and can surface platform for numerous indications in other respiratory and psychiatric conditions.
congruent with our strategy to shift treatment paradigms, both drugs could fill significant therapeutic gaps.
With our strategy to shift treatment paradigms, both drugs could fill significant therapeutic gaps.
And where it's one to one could become the first oral drug for bipolar depression in patients with acute and separate you'd suicidality.
N-Rx-1-1 could become the first oil drug for bipolar depression in patients with acute and subacute suicidality. As you know, COVID and recent events have had a significant adverse impact on the mental health and well-being of earning.
No Covid and recent events have had a significant adverse impact on the mental health and wellbeing of our nation.
We have all heard about the recent loss of lives due to suicide of well-known people and also of those only known to few.
You have all heard about the recent loss of lives due to suicide well known people and also although only known too few.
So infections have decreased hole that there's still with us in our opinion it will remain a global health threat. Despite promising data from emerging oral medications for patients in earlier stages of the disease.
Though infections have decreased, COVID is still with us. In our opinion, it will remain a global health crisis.
Despite promising data from emerging oral medications for patients at earlier stages of the disease, for patients with critical COVID-19 who are on high nasal floor and a respirator, there's still a large therapeutic.
For patients with critical COVID-19 were on her nasal floor on a respirator theres still a large therapeutic gap, we're losing still nearly 300 patients daily to Colby.
We're losing spill nearly 300 patients daily to COVID.
So let's talk about our psychiatry franchise in NRX 101.
So, let's talk about our psychiatry franchise and enriched water one as.
As we previously announced, we've re-initiated development of NRX 101 within our psychiatry franchise. NRX 101 is a patented oral medicine that could enable patients with bipolar depression and acute and subacute suicidality to be treated on an outpatient basis.
As we previously announced we re initiated development of interacts Wanda one within our psychiatry franchise editor X 101 is a patented oral medicine that could enable patients with bipolar depression, and acute and sub acute suicidality to be treated on an outpatient basis.
Both components in NRX101 are not scheduled substances and have not shown abuse potential, which could be a very important differentiator as NMDA antagonists such as ketamine can be highly.
Both components, and then or one O. One are not scheduled substances and have not shown abuse potential which could be a very important differentiator at the NMDA antagonist, such as ketamine can be highly addictive.
The treatment options for such patients are very limited. As anti-depressants carry a warning about the potential for inquiries risk of suicidal thoughts and behaviors, hence, patients as the risk of suicide unfortunately have been excluded from the majority of clinical studies for depression.
Treatment options for such patients are very limited.
Anti depressants carry a warning about the potential for inquiries, let's go suicidal thoughts and behaviors. Hence patients is the risk of suicide. Unfortunately have been excluded from the majority of clinical studies for depression.
Last week we announced that enrollment began in our Phase II trial for patients with bipolar depression, with subacute suicidal aviation and behavior, or SSIB. In this study, patients are being treated only on an outpatient basis, because this group does not require hospital.
Last week, we announced that enrollment began in our phase two trial for patients with bipolar depression with sub acute suicidal ideation and behavior or SSID.
In this study patients are being treated only on an outpatient basis, because this group does not require hospitalization.
Additional sites are being activated for this 70-patient study, and we're targeting to get to data by the end of the year.
Additional sites are being activated for the 70 patient study and we're targeting to get to data by the end of the year.
It is important to note that every year we lose nearly 50,000 people in the U.S. to suicide.
It is important to know that every year, we lose nearly 50000 people in the U S to suicide.
The 50,000 does not include lethal drug overdoses in this population, therefore, likely understating the actual number.
The 50000 does not include lethal drug overdoses in this population therefore likely understating the actual number.
In the U.S., we estimate that about 150,000 to 180,000 individuals with bipolar depression, with acute suicidal ideation and behavior, or ASIB, are hospitalized. And about two to three times as many have bipolar depression and thoughts of suicide, but do not require hospitalization.
In the U S.
We estimate that about 150 to 180000 individuals with bipolar depression with acute suicidal ideation and behavior or S. A S. I b are hospitalized in about two to three times as many have bipolar depression and parts of suicide, but do not require a hospitalization yet.
Overall, this represents a very high unmet medical
Overall this represents a very high unmet medical need.
It is estimated that around 50% of individuals with bipolar disorder attempt suicide in their lifetime.
It is estimated that around 50% of the individuals' with bipolar disorder attempt suicide in their lifetime and between 11% to 20% succumb to suicide.
and between 11 to 20% to come to suicide.
Given this very high unmet need, it is these individuals that we aim to help with NREX 101.
Given this very high unmet need it is these individuals' that we aim to help with N Reits 101.
Strategically, this positions NRX in a different segment than others working in the NMDA field, as others have focused on the traditional depression and treatment-resistant depression market, which is a much more crowded.
Strategically this positions interact in a different segment than others working in the NMDA feel as others have focused on the traditional depression in treatment resistant depression market, which is a much more crowded space, we call that antenna depressants, including those recently approved for bipolar depression carry a war.
Recall that antidepressants, including those recently approved for bipolar depression, carry a warning for the increased risk of suicide.
For the increased risk of suicide.
We believe interact pharmaceuticals can offer patients a highly differentiated treatment option to.
We believe NRX pharmaceuticals can offer patients a highly differentiated treatment.
To the best of our knowledge, N-R-X-1-1 is the only oral drug in advanced clinical trials designed to address bipolar depression with suicide.
To the best of our knowledge interacts wonder one is the only oral drug in advanced clinical trials designed to address bipolar depression.
It's about me.
we were awarded breakthrough therapy designation by the FDA or NRX 101 for severe bipolar depression in patients with ASIB after initial stabilization with ketamine or other effective therapy.
We were awarded breakthrough therapy designation by the FDA or interacts one or one for severe bipolar depression in patients with <unk> B after initial stabilization with ketamine or other effective therapy.
We plan to start a new NRX100 in special protocol agreement or spa study, NRX1 for 101, for patients with AACID in the second half of 2020.
We plan to start a new <unk> 100, and special protocol agreement or PA Spa study <unk> one one for one on one for patients with <unk> B in the second half of 2022.
Recall that as part of our Spa FDA provided guidance to us that the initial stabilization with ketamine should be done in a separate one to three day study.
Recalled as part of our SPA, FDA provided guidance to us that the initial stabilization with ketamine should be done in a separate one to three-day study. Those that stabilize can enroll in our NRX 101 versus lorazidone SPA study, in which the primary endpoint is depression.
Those that stabilized can enroll in our interacts Wanda one versus Lovaza don't sparse study and whats the primary endpoint is depression.
This study will be conducted with commercial level material and if successful could lead to a new dark application or NDA with the FBA for NRX 101.
This study will be conducted with commercial level material and if successful could lead to a new dark application or NDA with the FDA for interacts one O one.
Of note, restarting this study with commercial level material will better position NREX pharmaceuticals for potential NDA and commercial efforts.
Of note we starting this study with commercial level material will better position in Rx pharmaceuticals for potential NDA and our commercial efforts.
This psychiatry franchise is the starting foundation of our company, and with our knowledge, the potential for a highly differentiated product and broad patent estate, we're in a unique position to help patients in this area of high unmet need.
This psychiatry franchise is the starting foundation of our company and with our knowledge the potential for a highly differentiated product and broad patent of state. We are in a unique position to help patients in this area of high unmet need.
We're also considering exploring other high unmet need indications such as PTSD with suicidality.
We're also considering exploring other high unmet need indications such as PTSD with Suicidality.
Our intellectual property estate offers a range of options to combine other molecules and NMDA receptor antagonists, including with D-cycloserine, which is a component in Nrx1.
Our intellectual property estate offers a range of options to combine other molecules and NMDA receptor antagonist, including with these cycles theory, which is a component in <unk> one.
So, turning now to FASAMI, which is our proprietary formulation of aviptadil for the treatment of patients with acute respiratory failure and critical COVID-19 and potentially other respiratory diseases.
So turning now to say Sami.
<unk>, which is our proprietary formulation so that the DAU for the treatment of patients with acute respiratory failure and critical COVID-19, and potentially other respiratory diseases.
Fasami is currently being studied in intravenous form in a second phase 3 study of patients with critical COVID-19 who are experiencing respiratory failure.
Sami is currently being started in intravenous form the second phase III study of patients with critical COVID-19, who are experiencing respiratory failure.
This is the ACTIV-3B study, which is sponsored and managed by the U.S. National Institute of Health, or NIH. FESAMI was selected amongst a large number of other agents based on the promising science and data from our own study. In our view, ACTIV-3B is a vital study for our country in the fight against critical COVID-19.
This is the active three B study, which is sponsored and managed by the U S National Institute of health or an H C family was selected amongst a large number of other agents based on the promising signs and data from our own studies in.
In our view active three B is a vital study for our country in the fight against critical COVID-19.
Following a decline of cases signals are the cases are once again on the rise with the old Mcrobie a tube sub areas.
Following a decline of cases, signals are that cases are once again on the rise with the Omicron BA2 sub-variant.
According to a May 22 update from the CDC COVID data tracker, we're still losing nearly 300 people in the U.S. daily to COVID-19 and has lost nearly 1 million people total to this virus.
According to a may 22 updates from the CDC corporate data Cracker, we're still losing nearly 300 people in the U S daily to COVID-19 has lost nearly 1 million people total to this virus.
According to a Washington Post article this month, white officials expect a spike in cases in the fall.
According to a Washington Post article this month why does the officials expect a spike in cases in the fall.
Clinical experts signal that the BA2 subvariant of Omicron is highly transmissible. Therefore, we will believe that there will be continuing demand for improved therapeutics to treat the advanced stages of COVID-19, especially critical COVID-19.
Political experts signals that the D. A to some variant of omicron, it's highly transmissible.
Therefore, we will believe that they will be continuing demand for improved therapeutics to treat the advanced stages of COVID-19, especially critical COVID-19.
Yeah.
Last month, we announced the filing of a new breakthrough therapy designation or BTD request with the FDA. This submission includes data from a post hoc analysis of patients who were also treated with remdesivir and whose respiratory failure due to critical COVID-19 continued to progress.
Last month, we announced the filing of a new breakthrough therapy designation or BTB of request with the FDA. This submission includes data from a post hoc analysis of patients who were also treated with deaths a year and it was the respiratory failure due to critical COVID-19 continued to progress.
You may recall that our original BTT request was submitted in September of last year, which the FDA did not grant.
You may recall that our original BTT request was submitted in September of last year, which the FDA did not grant.
In its response, the FDA requested new clinical evidence comparing the safety and efficacy of cesami relative to other existing therapies for critical COVID-19, such as remdesivir.
And its response, the FDA requested new clinical evidence comparing the safety and efficacy of C. C. I mean relative to other existing therapies for critical COVID-19, such as from Desert.
Based on the FDA's input, we performed a post hoc analysis of our completed phase 2b3 study focused on the approximately 70% of patients that continued to progress to COVID-19 respiratory failure that also received treatment with remdesivir.
Just on the F D. A simple wood performed a post hoc analysis of our completed phase two b three study focused on the approximately 70% of patients. The continued to progress through COVID-19, respiratory failure that also receive treatment with room death severe.
This analysis showed that for these patients who were already treated with remdesivir and continued to deteriorate, their families showed a highly significant four-fold increase in survival odds compared to placebo at 60 days.
This analysis showed that for these patients who are already treated with firm death severe and continued to deteriorate.
Sami showed a highly significant four fold increase in survival odds compared to placebo at 60 days.
Safety data is of course crucial and has been an area of focus of the F. D. A.
Safety data is, of course, crucial and has been an area of focus of the FDA. This new filing included a recently completed cumulative safety analysis of approximately 750 patients across all programs treated with intravenous asami for critical COVID-19.
This new filing included a recently completed cumulative safety analysis of approximately 750 patients across all programs treated with intravenous see Sammy for critical COVID-19.
Our cumulative safety analysis identified no new or various drug reactions and an overall safety profile of IV cesami for critical COVID-19 that we believe is congruent with its use in the ICU and critical care setting.
Our cumulative safety analysis identified no new adverse drug reactions and an overall safety profile of IV Jeremy for critical COVID-19 that we believe is crew good with its used in the ICU and critical care setting.
In February , we submitted a new emergency use authorization request also focused on this narrower patient population.
In February we submitted a new emergency use authorization request also focused on this narrower patient population.
We continue to make progress on the manufacturing, you'll see Sammy recently, reaching up to eight months of stability into the refrigerated form and then the frozen form it may be stable for years. This is important as we do not know what the future of our COVID-19 May Herald.
We continue to make progress on the manufacturing of safe families, recently reaching up to eight months of stability in the refrigerated form and in the frozen form it may be stable for years. This is important as we do not know what the future of COVID-19 may herald.
The limitations of currently available therapies for COVID-19 were highlighted by the results of the solidarity trial study recently published in the Lancet, in particular for those in the more advanced stage of critical COVID-19.
The limitations of currently available therapies for COVID-19 were highlighted by the results of the Solidarity trial study recently published in the lancet in particular for those in the more advanced age of critical COVID-19.
Also, the promising data for oral compounds has emerged for the treatment of patients with earlier forms of COVID-19, including moderate and severe. Such agents do not work in all patients and may not be suitable for patients that are on respirators with critical COVID-19.
Also the promising data for oral compounds has emerged for the treatment of patients with earlier forms of COVID-19, including moderate and severe such agents do not work in all patients and may not be suitable for patients that are on respirators with critical COVID-19.
in spite of the advent of PaxLaville, we're still losing nearly 300 people to COVID daily.
In spite of the act.
The tax law Bill, we're still losing nearly 300 people to Covid daily.
Our view is that COVID-19 is likely to become endemic and that it will add 200,000 to 300,000 COVID ARDS cases per year.
Our view is that COVID-19 is likely to become endemic and that they will add 200000 to 300000 Covid L. D S cases per year.
During the first quarter it was announced at the NIH active through the trial has been clear to complete full enrollment of this trial is certainly a key study for <unk> in our view also for our nation's fight against COVID-19.
During the first quarter, it was announced that the NIH ACTIV-3b trial has been cleared to complete full enrollment. This trial is certainly a key study for CZAMI in our view also for our nation's fight against COVID-19.
It is scheduled to enroll 640 patients and enrollment has reached almost 75.
It is scheduled to enroll 640 patients and enrollment has reached almost 75%.
Fasami is the only new investigational treatment drug in this study focused on patients for whom there are few alternative therapies, especially once patients are in respiratory failure due to COVID-19. Recall that patients in this study
Hey, Sami is the only new investigational treatment drug in this study focused on patients for whom there are few alternative therapies, especially once patients are in respiratory failure due to COVID-19.
Recall that patients in this study attract for 90 days.
The next DSMB meeting is scheduled for May 25th of this year, instead of an originally planned meeting in April .
Next the SNB meeting scheduled for May 25th.
This year instead of the originally planned meeting in April .
The NIH ACTIV-3b trial leadership indicated that this new timing would allow the vast majority of patients enrolled to date to have reached the end of the observation period for the endpoint at 90 days.
And the NIH active <unk> trial leadership indicated that this new timing would allow the vast majority of patients enrolled to date to have reached the end of the observation period for the endpoint at 90 days.
We expect data from this trial by the end of the year notwithstanding periodic D. S. M B reviews.
We expect data from this trial by the end of the year, notwithstanding periodic DSMB reviews.
We continue to believe that CSAMI could be a valuable therapeutic for those with COVID-19 respiratory failure who have exhausted all other available therapies, especially when they reach the critical COVID-19 stage.
We continue to believe that see Sammy could be a valuable therapeutic for those with COVID-19, respiratory failure, who have exhausted all other available therapies, especially when they reached the critical COVID-19 stage.
To summarize, we see the following potential paths for CCME in 2020.
To summarize we see the following potential paths for C. C. I mean in 2022.
Number one, our ongoing EUA application for SafeAMI with our narrow patient population.
One our ongoing UA application for C. C. I mean with their narrow patient population scope.
And number two, the filing of a traditional new drug application or NDA with the FDA for three-sammary should the NIH active 3B study data support.
Number two the filing of a traditional new drug application or NDA with the F. D. A per se I mean should be NIH active through these studies data support this.
With data expected later this year, under fast track, we're allowed to initiate submissions of parts of our NDA, which could accelerate the process if the NIH study is successful.
With data expected later this year under fast track, we're allowed to initiate submissions of parts of our NDA, which could accelerate the process of the NIH study is successful.
We also will explore submission of FASAMI under the Accelerated Approval Pathway early in the second half of the year. The FDA instituted the Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate.
We also will explore submission if they say I mean under the accelerated approval pathway early in the second half of the year. The F. D. A instituted the accelerated approval program to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint as previously.
As previously disclosed, CCAMI showed a series of positive biomarker data, such as IL-6, that correlated with positive outcomes.
Clothes see Sammy showed a series of positive biomarker data such as IL six they're correlated with positive outcomes.
As mentioned in prior communications, we have partnerships with Cardinal Health for third party logistics and distribution services and with the <unk> for commercial and medical pharmacovigilance support upon potential E way or NDA approved.
As mentioned in prior communications, we have partnerships with Cardinal Health for third-party logistics and distribution services, and with Acuvia for commercial and medical pharmacovigilance support upon potential EOA or NDAs.
With that, I will turn it over to Ira for a brief overview of our financial results.
With that I will turn it over to IRA for a brief overview of our financial results.
Thank you Robert and good morning, everyone I would like to start by providing an overview of our financial results for the first quarter of 2022.
Thank you, Robert, and good morning, everyone. I would like to start by providing an overview of our financial results for the first quarter of 2022.
When comparing to the first quarter of 2021, please note that the company was privately held during the first quarter of 2021.
When comparing to the first quarter 'twenty 'twenty. One. Please note that the company was privately held during the first quarter 2021.
Research and development expenses for the three months ended March 31, 2022 totaled $5.5 million, compared to $2.9 million for the quarter ended March 31, 2021. The increase was primarily driven by an increase in clinical trials and development expenses related to CYFSA.
Research and development expenses for the three months ended March 31, 2022 totaled $5.5 million.
Compared to $2 $9 million for the quarter ended March 31, 2021.
The increase was primarily driven by an increase in clinical trials and development expenses related to say Sami.
General and administrative expenses for the three months ended March 31st, 2022 totaled $10.2 million, compared to $2.1 million for the three months ended March 31st, 2021. The increase of $8.1 million was primarily related to an increase of $4.4 million in legal, professional, and accounting fees.
General and administrative expenses for the three months ended March 31, 2022 totaled $10 $2 million compared to $2.1 million for the three months ended March 31 2021.
The increase of $8 $1 million was primarily related to an increase of $4.4 million in legal professional and accounting fees, an increase of $2.2 million and insurance expense, an increase of zero point $8 million in stock based compensation expense and an increase of zero point $7 million in other Jen.
an increase of 2.2 million dollars in insurance expense.
an increase of 0.8 million dollars in stock-based compensation expense and an increase of 0.7 million dollars in other general administrative
Administrative expenses.
The $10.2 million and $2.1 million of general and administrative expenses for the three months ended March 31, 2022 and 2021 included $1.1 million and $0.3 million, respectively, of non-cash stock-based compensation.
The $10.2 million and $2 $1 million of general and administrative expenses for the three months ended March 31, 2022 and 2021 included $1 1 million and zero point $3 million respectively.
Noncash stock based compensation.
For the three months ended March 31st, 2022, NRX Pharmaceuticals recorded gains of $2.1 million and $0.2 million for the change in fair value of earn out cash liability and warrant liability respectively.
For the three months ended March 31, 2022 and Rx pharmaceuticals recorded gains of $2.1 million and zero point $2 million for the change in fair value of earn out cash liability and warrant liability respectively.
NRX Pharmaceuticals recorded no such gains in the first quarter of 2021.
In Rx Pharmaceuticals recorded no such gains in the first quarter of 2021.
For the three months ended March 31st, 2021, NRX Pharmaceuticals recorded reimbursement expenses from Relief Therapeutics of $0.8 million, a $0.1 million gain on extinguishment of debt, and a non-cash settlement expense of $21.4 million related to the GEM warrant.
For the three months ended March 31, 2021 and Rx Pharmaceuticals recorded reimbursement expenses from relief Therapeutics, a zero point $8 million.
Zero point $1 million gain on extinguishment of debt and a noncash settlement expense of $21.4 million related to the gym warrant an Rx pharmaceuticals recorded no such items in the first quarter of 2022.
NRX Pharmaceuticals recorded no such items in the first quarter of 2022.
Net loss for the three months ended March 31, 2022 was $13 $4 million or 21 cents per share compared with a net loss of $25 $5 million or <unk> 71 per share for the three months ended March 31, 2021.
Net loss for the three months ended March 31, 2022, was $13.4 million, or $0.21 per share, compared with a net loss of $25.5 million, or $0.71 per share, for the three months ended March 31, 2021.
For the three months ended March 31st, 2022, NRX Pharmaceuticals used $10.4 million of cash in operating activity.
For the three months ended March 31, 2022 and Rx pharmaceuticals, he used $10.4 million of cash in operating activities.
compared to $3.0 million during the three months ended March 31, 2021.
Compared to $3.0 million during the three months ended March 31, 2021.
As of March 31, 'twenty, 'twenty, two and Rx pharmaceuticals held cash of $42 million compared to $27 $6 million as of December 31st 2021.
As of March 31st, 2022, NRX Pharmaceuticals held cash of $40.2 million, compared to $27.6 million as of December 31st, 2021.
we believe we have sufficient cash to support operations for at least the next 12
We believe we have sufficient cash to support operations for at least the next 12 months.
With that, I will turn it back to Robert for closing remarks.
With that I'll turn it back to Robert for closing remarks.
Thank you IRA.
Thank you, Ira. In conclusion, we're executing on our development plans for our two late-stage potentially life-saving drugs.
In conclusion, we're executing on our development plans for our two late stage potentially life saving drugs interact one O. One for bipolar depression in patients with acute and sub acute suicidal ideation and behavior and see Sammy delivered intravenously for critical COVID-19 patients both drugs if.
NRX101 for bipolar depression in patients with acute and subacute suicidal deviation of behavior, and SESAME delivered intravenously for critical COVID-19 patients. Both drugs, if successful, could significantly change patient care in their respective areas as they have properties that could make them highly differentiated products.
Vessel could significantly change patient care in their respective areas as they have properties that could make them highly differentiated product.
Data is expected for both within the next nine to 18 months. We also see opportunities to leverage both compounds in other populations in disease areas with high unmet needs, which we're also exploring. PTSD with suicidality is an area.
Data is expected for both within the next nine to 18 months, we also see opportunities to leverage both compounds in other populations and disease areas with high unmet needs, which we are also exploring.
T T S D with Suicidality as an area of high unmet need.
Recall that face AMI has applicability for ARDS that is not related to COVID. A phase one study in sepsis ARDS was actually the basis for us starting our COVID-19 program, and there are other indications as well.
We call that the CME has applicability for a R. D. S that is not related to Covid a phase one study in sepsis L. D. S was actually the basis for our starting our COVID-19 program and there are other indications as well.
We're excited about restarting development work in our psychiatry franchise at the COVID pandemic. Unfortunately, also created a mental health strain on our nation.
We're excited about restarting development work and I was like how.
IGT franchise as the Covid pandemic. Unfortunately also created a mental health strain on our nation.
N-Rx-form resuticles was founded on a commitment to the application of innovative signs to known molecules to address a very high-on metmedical...
<unk> Pharmaceuticals was founded on the commitment to the application of innovative signs to known molecules to address a very high unmet medical needs. This continues to be our focus and we remain confident in the opportunities before us pump.
This continues to be our focus and we remain confident in the opportunities before us. Tom, we're ready to take some questions.
Tom we're ready to take some questions.
Thank you, Robert. Our first investor question is.
Thank you Robert our first Investor question is.
What is your view regarding the impact of potential approval of Vero's drug and also Paxilovid being?
What is your view regarding the impact of a potential approval of various drugs and also tax loaded being used.
Okay. Both medicines are oral medicines targeted at earlier COVID-19 populations. Paxilivir has been on the market now for a few months, and unfortunately, it does not work for all. And it is an oral medicine that needs to be taken quite soon after disease onset.
Okay.
Both medicines are all medicine targeted at earlier COVID-19 populations tax law that has been on the market now for a few months and unfortunately, it does not work for all and it is an oral medicine that needs to be taken.
Quite soon after disease onset.
Sabizavulin, I hope I'm pronouncing that correct, is an oral medication that was tested in moderate and severe COVID-19 patients.
So for example, when I'm hope I am pronouncing that correct.
<unk> is an oral medication that was tested in moderate and severe COVID-19 patients.
So your family is targeted that critical COVID-19 patient segment in essence, those who are in the ICU on high nasal floor intubated.
CSAMI is targeted at the critical COVID-19 patient segment. In essence, those who are in the ICU on high nasal flow are intubated.
Recall that PAX COVID was tested in the ACTIV 3b study as well, and it was discontinued due to futility and critical COVID-19.
Recall that <unk> was tested in the active <unk> study as well and it was discontinued due to futility and critical COVID-19.
So ifami is now the only medicine to our knowledge still being tested in the NIH active 3B protocol for critical COVID-19.
See families now are the only medicine to our law still being tested in DNI age active through the protocol for critical COVID-19.
Also note that the White house recently forecast, a new wave of Covid for the fall and winter based on that what we know today.
Also note that the White House recently forecast a new wave of COVID for the fall and winter. Based on that, what we know today, we do see continued high unmet need for patients with critical COVID-19.
We do see continued high unmet need for patients with critical COVID-19.
Okay.
Yeah.
Okay, our next question, Robert, how do you see NRX101 in comparison to Axone's and Romelda's compounds, which are in late phase?
Okay. Our next question Robert how do you see interacts one O. One in comparison to Exxon's animal model does compounds, which are in late phase III.
That's a quite interesting question.
That's a quite interesting question.
Well, first, their programs validate the mechanistic approach of combining an NMDA antagonist with a 5-HT2 compound.
Well first there programs validate the mechanistic approach of combining an M D. A antagonist with a five H T two compounds.
As I mentioned in my remarks before, we have positioned NRX 101 in the bipolar depression with suicidality space for which FDA awarded us breakthrough therapy designations.
As I mentioned in my remarks, before we have positioned <unk> one O. One indeed, bipolar depression, suicidality space for which FDA awarded us breakthrough therapy designation.
Their programs are focused on MDD, treatment of resistant depression, adjunctive treatment, et cetera.
Their programs are focused on M. D D treatment resistant depression, adjunctive treatment et cetera.
We know that up to 50% of individuals in bipolar disorder attempt suicide or experience serious thoughts of suicide over their lifetime and between 11 and 20% unfortunately succumb to suicide.
We know that up to 50% of individuals' in bipolar disorder attempt suicide or experienced serious thoughts of suicide over their lifetime and between 11 and 20% Unfortunately come to suicide.
We also think that it's advantageous that both NRX 101 components are not scheduled as abuse potential is of high.
We also think that it's advantageous to both <unk> 101 components are not schedule.
As abuse potential is of high concern.
We also think that studying patients with depression and suicidality is of great importance in the bipolar space, given that current drugs carry warnings about the increased risk of suicide.
We also think that studying patients with depression suicidality of great importance in the bipolar space given the current drugs carry warnings about the increased risk of suicide.
And also, we have built a solid intellectual property position for NX101, including a composition of matter.
And also we have built a solid intellectual property position for next one to one including a composition of matter patent.
Okay.
Okay.
Okay, that's all the questions we have. Thank you, everyone. This is all the time we have for questions. Thank you, everyone, for joining us this morning. This concludes the NRX Pharmaceuticals first quarter 2020 results conference call. Thank you all for participating.
Okay. That's all the questions. We have thank you everyone. This is all the time we have for questions. Thank you everyone for joining us. This morning. This concludes the <unk> Pharmaceuticals first quarter 2000, Twenty's results conference call. Thank you all for participating.
Thank you.
Thank you very much. Ladies and gentlemen, this concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
Thank you very much ladies and gentlemen. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.
Yeah.
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