Q2 2022 NRX Pharmaceuticals Inc Earnings Call
[music].
Good day and welcome to the M. R X pharmaceuticals second quarter 2022.
Speaker 1: Good day and welcome to the NRX Pharmaceutical 2nd Quarter 2022 Farmers Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.
Conference call.
All participants will be in a listen only mode.
So do you need assistance, please signal a conference, especially my pressing they starkey Homebase L.
After todays presentation, there will be an opportunity to ask questions.
Speaker 1: After today's presentation, there will be an opportunity to ask questions.
To ask a question you May Press Star then one Oh your Touchtone phone should we draw. Your question. Please press Star then two.
Speaker 1: To ask a question, you may press star then one on your touchstone phone. To withdraw your question, please press star then two.
Please note this event is being recorded.
Speaker 1: Please note, this event is being recorded. I would now like to hand the conference over to Tom Johnson. Please go ahead.
I would now like turn the conference over to Tom Jones from <unk>. Please go ahead.
Speaker 2: 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 US and federal securities.
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 laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.
Speaker 2: These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectation.
Speaker 2: 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 the date thereof and the company undertakes no obligation to update or revise these forward-looking statements.
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 the date hereof and the company undertakes no obligation to update or revise these 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 interaction Pharmaceuticals, Inc website joining.
Speaker 2: Information presented on this call is contained in the press release issued earlier today and in the company's form 10Q that we're filing today Which may be accessed from the investors page of the NREX pharmaceuticals Inc website
Speaker 2: Joining me on today's calls from Anorex Pharmaceuticals are Stephen Willard, Chief Executive Officer, and Seth VanPourhies, Chief Financial Officer and Treasurer. Steve will provide a summary of the company's progress before turning it over to Seth for review of the financial results.
With me on today's calls from interacts pharmaceuticals, where Stephen Willey.
Executive Officer, and Seth Van Voorhees, Chief Financial Officer, and Treasurer, Steven will provide a summary of the Companys progress before turning it over to Jeff for a review of the financial results Paul.
Speaker 2: Following their prepared remarks, Stephen and Seth will be joined by Robert Bessoff, head of operations and chief commercial officer, to address investor questions. I will now turn the call over to Stephen. Thank you, Tom.
Following their prepared remarks, Steven itself would be jumbo Robert best off head of operations and Chief commercial officer to address Investor questions. I will now turn the call over to Steve.
Thank you Tom.
Good morning, everyone and thank you for joining us today.
Speaker 2: I'm excited to host my first quarterly results call as CEO of NRX Pharmaceuticals.
I'm excited to host my first quarterly results call as C. E O N R X pharmaceuticals.
Speaker 2: I've spent a large portion of my career in both private industry and public service dedicated to advancing compelling science to benefit people and to build value for shareholders.
I spent a large portion of my career in both private industry and public service dedicated to advancing compelling science to benefit people and to build value for shareholders.
Speaker 2: When I decided to assume the leadership role of NRX, I saw an opportunity to do both.
I decided to assume the leadership role in Iraq, I saw an opportunity to do both.
Speaker 2: Joining me in this endeavor are Cez Van Voorhis, our new chief financial officer, Jonathan Javitt, our chief scientific officer, and Robert Bestoff, head of operations and chief commercial officer.
Joining me in this endeavor.
So that's been Borys, our new Chief Financial Officer, Jonathan <unk>, Chief Financial Scientific Officer, and Robert Best Head of operations and Chief Commercial Officer.
Speaker 2: We appreciate your attendance today and look forward to engaging with you on this and future calls as we work to realize the opportunities before us.
We appreciate your attendance today.
Look forward to engaging with you on this in future calls.
We work to realize the opportunities before us.
Before discussing our second quarter results and plans for the balance of this year.
Speaker 2: before discussing our second quarter results and plans for the balance of this year.
Speaker 2: I wanted to take a few moments to highlight what attracted me to the opportunities of actual conservationist John
Wanted to take a few moments to highlight what attracted me to the opportunities. There then alright.
Speaker 2: First, NRX has an extraordinary organization with a strong scientific and regulatory foundation and a unique and robust intellectual property portfolio.
First in Iraq has an extraordinary organization with a strong scientific and regulatory foundation, and a unique and robust intellectual property portfolio.
Speaker 2: This fact is a point of differentiation between the NRX and many of its competitors.
This fact has appointed differentiation between <unk> and many of its competitors.
Speaker 2: Second, our lead asset, NRX 101, forms the basis of a psychiatry franchise with potential applications in the array of mental health issues such as PTSD and other major depressive disorders.
Second I lead as it interacts one O one forms the basis of the psychiatry franchise with potential applications and the array of mental health issues, such as P. T S D and other major depressive disorders.
Speaker 2: And third, our renewed development program for NRX 101 seeks to address significant unmet medical needs and bipolar depression that also represent a significant commercial opportunity.
And third a renewed development program or interacts one O. One seeks to address significant unmet medical needs in bipolar depression.
<unk> represents a significant commercial opportunity.
Together with a strong team that has a track record of rapidly developing and bringing life saving medications to market I am delighted to be leading the effort to change the treatment paradigm for those patients and deliver value to all of us.
Speaker 2: Together with a strong team that has a track record of rapidly developing and bringing life-saving medications to market, I am delighted to be leading the effort to change the treatment paradigm for those patients and deliver value to all of us.
So let's begin.
And our X one O one too.
To our knowledge interacts one one is the only oral anti depressants the targets patients with bipolar depression enacted suicidality, which typically is an exclusion criteria.
Speaker 2: To our knowledge, NRX-101 is the only oral antidepressant that targets patients with bipolar depression and active suicidality, which typically is an exclusion criteria in clinical studies of depression and PTSD.
The nickel studies of depression and PTSD.
Speaker 2: Data from one of our previously completed phase 2 clinical trials shows a significant reduction in both depression and suicidality compared to standard therapy in patients with bipolar depression who were acutely suicidal and who were initially spabilized with ketamine.
Data from one of our previous complete previously completed phase two clinical trials shows the significant reduction in both depression and suicidality compared to standard therapy in patients with bipolar depression, who are acutely suicidal and who were initially stabilize with ketamine.
Speaker 2: We have also released preclinical findings demonstrating that, unlike ketamine, the key component in NRX-101 is not addictive.
We have also released preclinical findings demonstrating that.
Unlike ketamine key component and then our X 101 is not addictive.
Moreover, we have shared with you the peer reviewed biomarker findings from Columbia University, showing that interacts one O. One achieves the same chemical changes in the brain has ever achieved by Caribbean and that these changes are statistically correlated with improvement in depression.
Speaker 2: Moreover, we have shared with you the peer-reviewed biomarker findings from Columbia University showing that NRX-101 achieves the same chemical changes in the brain as are achieved by ketamine and that these changes are statistically correlated with improvement in depression.
101 is the only psychiatry drug that has been granted the biomarker letter by S. T E, which you may read on the F. D a website.
Speaker 2: NRX-101 is the only psychiatry drug that has been granted the biomarker letter by FDA, which you may read on the FDA website.
The potential oral non addictive nature of N I heard.
Speaker 2: The potential oral non addictive nature of NRX 101 therapy combined with its potential therapeutic effects to reduce both depression and suicidality offers significant advantages over other commercial and developmental drugs as a new therapeutic option for bipolar patients.
101 therapy combined with its potential therapeutic effects to reduce both depression suicidality offer significant advantages over other commercial and developmental drugs.
A new therapeutic option for bipolar patients.
During our second quarter, we met our stated milestones for advancing and Eric's wonder what the commercialization, let me share the catalysts, we project for the rest of the year.
Speaker 2: During our second quarter, we met our stated milestones for advancing NRX-101 to commercialization. Let me share the catalyst we project for the rest of the year.
We initiated enrollment in our new phase two trial of interacts one O one patients.
Speaker 2: We initiated enrollment in our new phase two trial of NRX 101 patients, and patients who have bipolar depression would subacute suicidal ideation and behavior, and have activated 10 clinical sites, which represents about two-thirds of our intended sites. Additional sites are being activated soon, and enrollment is ongoing.
And Ah patients, who has bipolar depression, which sub acute suicidal ideation and behavior and have activated 10 clinical sites, which represents about two thirds of our intend to charge additional sites are being activated soon and enrollment is ongoing.
This 70 patient study is targeted at patients with bipolar depression, and Suicidality that do not require hospitalization. We expect to upgrade this trial to the phase III as soon as we released our newly manufactured phase III bad supply and have received the Fda's guidance on primary and secondary endpoints.
Speaker 2: This 70-patient study is targeted at patients with bipolar depression and suicidality that do not require hospitalization. We expect to upgrade this trial to a phase 3 as soon as we release our newly manufactured phase 3 drug supply and have received FDA's guidance on primary and secondary endpoints.
Speaker 2: This trial in subacute patients who were treated in the outpatient setting aims to achieve a substantial enlargement of our potential indication from the 150 to 180,000 patients with bipolar depression and acute suicidality to the significantly larger population of patients being treated in the ambulatory setting. As I mentioned at the annual meeting of shareholders, we view this as a $2 billion opportunity.
This traveling sub acute patients who were treated in the outpatient setting.
Aims to achieve a substantial enlargement of our potential indication from the 150 to 180000 patients with bipolar depression and acute suicidality to the significantly larger population of patients being treated in the ambulatory setting.
As I mentioned at the annual meeting of shareholders. We view this as a 2 billion dollar opportunity.
The sub acute trial also reflects the request has been about steady clinicians who voiced the desire to also treat patients who were on the verge of needing to be hospitalized due to their increased thoughts of suicide.
Speaker 2: This subacute trial also reflects the request of many of our study clinicians who voiced the desire to also treat patients who were on the verge of needing to be hospitalized due to their increased thoughts of suicide.
And our X one O. One is the first drug introduced for these patients that has shown potential to decrease rather than increase risk of suicide. Unlike SSRI anti depression.
Speaker 2: NRX-101 is the first drug introduced for these patients that has shown potential to decrease rather than increase risk of suicide, unlike SSRI antidepressants, and perhaps even reduce the need for hospitalizations. We project a readout of the data of this trial by the end of 2022 or in the first quarter of 2023 and look forward to adding it to our registration package.
And perhaps you can reduce the need for hospitalizations, we projected readout of the data in this trial, but yeah. It was 2022 were in the first quarter 'twenty to 'twenty, three and look forward to adding it to our registration package.
During the second quarter, we also advanced preparations to restart our phase three trial.
Speaker 2: During the second quarter, we also advanced preparations to restart our phase three trial of NRX-101 in patients with acute suicidal ideation and behavior under a special protocol agreement awarded to us by FDA.
101 in patients with acute suicidal ideation and behavior.
Under a special protocol agreement awarded to Us by S. P. A.
Speaker 2: This study will be conducted with commercial level material and if successful, could lead to a new drug application or NDA with the FDA for NRX 101 by late 2023 for the first half of 2024.
This study will be conducted with commercial level material and if successful could lead to a new drug application or NDA with the FDA for interacts winter one by late 'twenty to 'twenty, three where the first half of 'twenty 'twenty four.
Speaker 2: Recall that as part of our special protocol agreement with the FDA, the agency advised us in writing that successful completion of this trial would permit a regulatory filing for drug approval.
Recall that as part of our special protocol agreement with the FDA The agency advisors.
Right and the successful completion of this trial would permit a regulatory filing for drug approval.
Speaker 2: Conducting this trial with commercial level material is key to submitting clinical data on a rolling basis under a breakthrough designation by, as I said, mid-2023, a potential NDA filing by year-end 2023, and commercialization as early as 2024.
Inducting this trial with commercial level material is key to submitting clinical data on a rolling basis under our breakthrough designation by as I said mid 'twenty 'twenty three the potential NDA filing by year end 'twenty 'twenty, three and commercialization as early as 2024.
During the first half of 2022 we transferred manufacturer then our X one to one to Alchemy Corporation in North Carolina in order to enable phase III readiness and preparedness for commercial stage.
Speaker 2: During the first half of 2022, we transferred manufacturers NRX1-1 to Alchemy Corporation in North Carolina in order to enable phase three readiness and preparedness for commercial stage. We have recently manufactured
We have recently manufactured our first batch of medicine.
Manufacturing is a crucial element to achieving submission readiness and approval for a new drug.
Speaker 2: Manufacturing is a crucial element to achieving submission readiness and approval for a new drug. This investment is an important piece of our overall plan to initiate our Phase IIb-3 Registrational Study with commercial level materials.
This investment is an important piece of our overall plan to initiate our phase two b slash three registrational study with commercial level materials.
The psychiatric safety psychiatry franchise.
Speaker 2: The psychiatric psychiatry franchise is the starting foundation of our
Starting to foundation of our company.
Speaker 2: And with our broad patent estate, we believe we are in a unique position to deliver a highly differentiated product to help patients in this area of very high unmet medical.
And with our broad patent estate, we believe we are in a unique position.
Liver, a highly differentiated products to help patients in this area of very high unmet medical need.
We are also considering exploring other high unmet medical need indications such as P. T. S. P C. Richard.
Speaker 2: We are also considering exploring other high unmet medical need indications, such as PTSD with suicidality.
That would be.
There are approximately 9 million individuals in our country. It experienced P. T. S. T. One third of them have severe P. T S T.
Speaker 2: There are approximately 9 million individuals in our country that experience PTSD. One third of them have severe PTSD.
Between 17, and 22 members of our armed forces as veterans are lost every day to suicide.
Speaker 2: Between 17 and 22 members of our armed forces as veterans are lost every day to suicide.
Speaker 2: We view this as another very high unmet medical need.
We view this as another very high unmet medical need.
Speaker 2: Our intellectual property estate offers a range of options to combine a variety of molecules and NMDA receptor antagonists, including d-cyclosurine, a component of NRX-101.
Our intellectual property estate offers a range of options to combine a variety of these molecules and NMDA receptor antagonist, including disciples theory, a component about IraQ1 on one.
Turning to slide Sammy.
As we announced in May the NIH Act is three D to C code trial was stopped for futility.
Speaker 2: As we announced in May, the NIH ACT-IS 3B TACICO trial was stopped for futility.
Speaker 2: COVID-19 continues to be an unpredictable and challenging area, as evidenced by another clinical trial done recently for another company by the NIH that also did not read out with the desired efficacy.
COVID-19 continues to be an unpredictable and challenging area as evidenced by another clinical trial done recently for another company by the NIH that also did not read out with the desired efficacy.
Our assessment of future options present, Sami will be guided by the independent analysis of the United States.
Speaker 2: Our assessment of future options for Xisami will be guided by independent analysis of the NIH data, along with data we received from an independent assessment of chest X-rays from a sub-study that included a sub-group of approximately 80 patients that had survived to day 10 during our Phase 2B-3 study.
Along with data we received from an independent assessment of chest X rays from a sub study that include a subgroup of approximately 80 patients that are hedged survive today 10 during our phase two b slash three study.
Speaker 2: This sub-study showed a statistically significant improvement in chest x-rays using real scores in patients with COVID-19 respiratory failure compared to a worsening in patients.
This sub study showed a statistically significant improvement in chest X rays, using real scores in patients with COVID-19, respiratory failure compared to a worsening in patients treated.
With placebo and that P was less than point of applause.
Speaker 2: with placebo and that p was less than 0.05.
Speaker 2: We expect to receive the NIH data in late third quarter or early fourth quarter, and we'll conduct an independent analysis at this time.
We expect to receive the NIH data in late two says late.
Third quarter or early fourth quarter and will conduct an independent analysis at the time.
Speaker 2: Earlier this year, we completed manufacturer Phase 3 commercial-ready Vifami. We are not funding additional trials with Vifami at this time.
Earlier this year, we completed manufacturing phase III commercial ready then Sammy.
We are not funding additional trials to judge any at this time.
With that I will turn it over to Seth for a brief overview of our financial results.
Speaker 2: With that, I will turn it over to Seth for a brief overview of our financial results.
Thank you Steven and good morning, everyone.
Like Stephen I'm delighted to be part of the <unk> leadership team I look forward to discussing our results and plans with you.
Speaker 3: Like Stephen, I'm delighted to be part of the NRX Leadership Team, and I look forward to discussing our results and plans with you.
First I'd like to comment on our recent restatement of our financial results for the second and third quarter of 2021.
Speaker 3: First, I'd like to comment on our recent restatement of financial results for the second and third quarter of 2021.
At the time of our merger in May of last year warrants and a private company and your Rx were exchanged for warrants and the public company Big Rock Partners acquisition Corp.
Speaker 3: At the time of our merger in May of last year, warrants in the private company NewerRx were exchanged for warrants in the public company Big Rock Partners Acquisition Corp., which exceptionally would remain NRX pharmaceuticals.
Which subsequently was renamed <unk> Pharmaceuticals.
Speaker 3: These warrants were initially classified as equity in our financial report.
These warrants were initially classified as equity in our financial reports.
Speaker 3: However, in the process of preparing our financial statements for the second quarter of 2022, we concluded that the contingent features of these substitute warrants required that they be classified as a liability and not as equitable.
However, in the process of preparing our financial statements for the second quarter of 2022.
We concluded that the contingent features a beam substitute warrants requires that they be classified as a liability and not as equity.
Speaker 3: Last week, we detailed this issue in an 8K and restated the second and third quarter reports for fiscal year 2021.
Last week, we detailed the tissue in an 8-K and restated the second and third quarter reports for fiscal year 2021.
The change resulted in a $15 $9 million reduction in net loss from $16 1 million to 0.1 million for the three months ended June 32021.
Speaker 3: The change resulted in a $15.9 million reduction in net loss from $16.1 million to $0.1 million for the three months ended June 30, 2021.
And a comparable offsetting increase in the net loss during the third quarter of 2021 of $16 $3 million.
Speaker 3: and a comparable offsetting increase in the net loss during the third quarter of 2021 of $16.3 million from $20.8 million to $37.0 million for the three months ended September 30, 2021.
From $20 8 million to 37.0 million for the three months ended September 30th 2021.
The Euro had no impact on our cash balance.
Speaker 3: The era had no impact on our cash balance and no impact on our operating cash flows and did not have a material impact on the company's consolidated financial statements for the full year.
And no impact on our operating cash flows.
And did not have a material impact on the company's consolidated financial statements for the full year.
Speaker 3: Now I'd like to discuss our financial results for the second quarter of 2022.
Now I'd like to discuss our financial results for the second quarter of 2022.
Research and development expenses for the three months ended June 32022 totaled $3.0 million comp.
Speaker 3: Research and development expenses for the three months ended June 30, 2022 totaled $3.0 million.
Compared to $4 7 million for the same courage in fiscal 2020 one.
Speaker 3: compared to $4.7 million for the same period in fiscal 2021.
Speaker 3: The decrease of $1.7 million related primarily to a decrease in clinical trial and developmental expenses related to xisami.
The decrease of $1 7 million related primarily to a decrease in clinical trial and developmental expenses related to Zeiss Tommy.
For the six months period, R&D expenses totaled $8 4 million as compared to $7.6 million for the same period in fiscal year, 2020 one.
Speaker 3: For the six month period, R&D expenses totaled $8.4 million as compared to $7.6 million for the same period in fiscal year 2021.
Speaker 3: the increase of $0.9 million related primarily to an increase in regulatory and process development expenses.
The increase of 0.9 million related primarily to an increase in regulatory and process development expenses.
General and administrative expenses for the three months ended June 32022 totaled $6 $6 million as compared to $12 $5 million in the same period in fiscal year, 2020 one.
Speaker 3: General and administrative expenses for the three-month ended June 30, 2022, totaled $6.6 million as compared to $12.5 million in the same period in fiscal year 2021.
The decrease of $5 8 million was primarily related to a decrease in stock based compensation and consulting fees, partially offset by an increase in higher insurance related expenses.
Speaker 3: The decrease of $5.8 million was primarily related to a decrease in stock-based compensation and consulting fees partially offset by an increase in higher insurance-related expenses.
Speaker 3: For the six month period, GNA expenses totaled 16.9 million in fiscal year 2022, as compared to 14.6 million for the same period in fiscal year 2021.
For the six month period, G&A expenses totaled 16, $16 9 million in fiscal year 2022, as compared to $14 6 million for the same period in fiscal year 2021.
The increase of $2 3 million was primarily related to an increase in legal professional and insurance expenses, partially offset by a decrease in consulting fees and stock based compensation expenses.
Speaker 3: The increase of $2.3 million was primarily related to an increase in legal, professional, and insurance expenses, partially offset by a decrease in consultant fees and stock-based compensation expenses.
Speaker 3: For the three month period ended June 30, 2022, our net loss was $7 million, as compared to a net loss of $0.1 million for the three months ended in June 30, 2021.
For the three months period ended June 32022, our net loss was $7 million as compared to a net loss of 0.1 million for the three months ended in June 32021.
Speaker 3: For the six month period, our net loss was $20.4 million as compared with the net loss of $25.6 for the same period in 2021.
For the six month period, our net loss was $20 4 million as compared with a net loss of $25 six for the same period in 2021.
Now I'd like to comment on our cash resources.
As of June 32022, we reported a cash balance of $24 $5 million.
Speaker 3: As of June 30, 2022, we reported a cash balance of $24.5 million.
Speaker 3: We believe that we have sufficient funds and, if necessary, the ability to reduce expenditures to support our operations through August of 2023.
We believe that we have sufficient funds and if necessary the ability to reduce expenditures to support our operations through August of 2023.
We may consider raising capital during this year to further strengthen our balance sheet and to support our clinical trials and other operational activities.
Speaker 3: we may consider raising capital during this year to further strengthen our balance sheet and to support our clinical trials and other operational activity.
With that I'll turn it back to Steven for closing remarks Steven.
Speaker 3: With that, I'll turn it back to Stephen for closing remarks. Stephen?
Thank you Seth.
To conclude we are excited about restarting development work in our psychiatry franchise the.
Speaker 2: To conclude, we're excited about restarting development work in our psychiatry firm.
Speaker 2: The unmet medical needs and bipolar depression with suicidality are enormous.
The unmet medical needs in bipolar depression Suicidality are enormous.
Today, we estimate that U S annual peak sales potential for bipolar depression, suicidality to be around $2 billion a year.
Speaker 2: Today, we estimate that US annual peak sales potential for bipolar depression with suicidality to be around $2 billion a year.
Speaker 2: There are only five drugs currently approved for bipolar depression, and all of them carry the warning of increased suhocidality.
There are only five drugs currently approved for bipolar depression, and all of them carry the warning of increased suicidality.
Our phase two study showed that interacts wanted one has the potential to treat bipolar depression in patients with Suicidality.
Speaker 2: Our phase two study showed that NRX-101 has the potential to treat bipolar depression in patients with suicidality. That is why the FDA gave us breakthrough therapy designation and a special protocol agreement for registrational studies of less than 150 patients. If successful, this could lead to a commercialized product as early as 2024 and significant potential development.
That's why the FDA gave us breakthrough therapy designation and a special protocol agreement for Registrational studies of less than 150 patients.
Accessible this could lead to a commercialized product as early as 'twenty 'twenty four and significant potential.
We believe that interacts one on one as a potentially life saving medicine that could change the treatment paradigm for individuals with bipolar depression, but are also experiencing suicidality.
Speaker 2: We believe that NRX-101 is a potentially life-saving medicine that could change the treatment paradigm for individuals with bipolar depression that are also experiencing suicidality. With that, we will take some questions.
Tom with that we'll take some questions.
Okay.
Thank you.
Sure.
Well now begin the question and answer session to ask a question you May press has probably gone along only attached on Paul.
Speaker 1: We will now begin the question and answer session. To ask a question, you may press star 1 on your touch-tone phone. If you are using a speakerphone, please pick up your headset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star 2.
Okay.
I think the phone please.
Copper had cited before pressing the keys.
If at any time your question has been addressed.
I'd like to withdraw your question. Please press Star then two.
Speaker 1: At this time, we will pause momentarily to assemble our roles.
At this time, well pause momentarily to assemble all are well.
Yeah.
Yeah.
Yeah.
And our first question comes from Daniel Brennan with <unk>.
Speaker 1: And our first question comes from Vernon Bernardino with HC. Wayne is right.
C.
Right.
Hi, Thanks for taking my question and Steven first of all welcome aboard.
Speaker 4: Hi, thanks for taking my question and Steven says welcome aboard. Looking forward to catching up to you in person in the near future.
Looking forward to catching up to you in person in the near future.
Speaker 4: Regarding the repatriated NRS-101 drug supply, just wondering if you could go through the mechanics of perhaps the history of that process and what was the situation before that repatriation.
Regarding the repatriated and RF are one on one drug supplier just wondering if you could go through the mechanics of perhaps a history.
Of that process and what were what was the situation before.
The repatriation.
Vernon. Thank you very much for your call and your interest in us.
Speaker 2: Vernon, thank you very much for your call and your interest in this. Robert, would you like to handle that question?
Robert would you like to handle that question you.
Yes, hi, good morning, Vern or how would you think you're pretty sure Robert.
Speaker 3: Yes. Hi, good morning, Vernon. How are you? Thank you for your time.
Speaker 3: Okay, so we had initially produced clinical material at Wuxi in China, and that is the material we've used to date in our clinical studies and also the material that is being used currently in the phase two study.
Hey, So we had initially a produce clinical material at Wuxi in China and that is the material. We've used to date in our clinical studies and also the material that is being used currently in the phase two study.
Speaker 3: As you know, CMC is a crucial part of the regulatory submission process, and we felt it was appropriate to transfer that process, which we started late last year in this first half of the year, to the U.S., to Alkimi. And we've now started producing material, and we will be using that material in our Phase III study. So, we've successfully produced batches.
As you know CMT is a crucial part of the regulatory submission process and we felt it was appropriate to transfer that process, which we started late last year and this first half of the year or.
Two the you want a.
Two alchemy, and we've now started producing material and.
And we will be using that material in our phase III study. So we successfully produced batches.
Speaker 3: that will be released and we expect to be using that material in our phase three study later.
That will be released and we expect to be using that material in our phase III study later this year.
Now part of that was a desire to control the supply because of exactly shipping okay, well not only thing, but it was our desire to have that in the U S closer to losses at that time I recall, we also had COVID-19 at that time.
Speaker 4: Now part of that was a desire to control the supply because of issues with shipping. Exactly. Well, not only with shipping, but it was our desire to have that in the US closer to us at that time. Recall, we also had COVID at that time. We didn't know where things could go, and we felt Alchemy is an excellent partner to transfer the manufacturing.
We didn't know where things could go and we felt oh can we have an excellent partner to transfer the manufacturing too.
Okay.
Speaker 4: Okay, maybe this is for Seth. Is there any accounting considerations as far as that supplies location there?
Maybe this is for SAP is there any.
Accounting.
Considerations as far as that supply location.
Yeah.
That needs to be.
Considered.
Speaker 3: No, I mean there obviously will always be things in terms of exchange rate fluctuations, but nothing material that we anticipate.
No I mean, they're obviously well always be things in terms of exchange rate.
Fluctuations, but.
Nothing nothing material that we anticipate.
Okay.
Speaker 4: Okay, one more question, and then I'll get one more question, and then that's all I have, if I could. Regarding the supply of the SAMHSA, is there any accounting considerations that you're looking at there, considering they're made, at least in my opinion, a possible impairment if future studies aren't pursued?
One question and then I'll go to Walmart.
One more question and then that's all I have if I could regarding the supplier of the family there any accounting considerations that youre looking at there considering they're.
They're made.
At least in my opinion, a possible impairment if a future studies aren't pursued.
Yes.
Speaker 3: I'm sorry, could you repeat the question? You broke up in the middle, so I didn't quite catch it.
I'm sorry could you repeat that question you broke up.
In the middle so I didn't quite catch it.
Sorry, it's probably cause me mumbling, but is there any.
Speaker 4: Sorry, it's probably just me mumbling, but is there any accounting consideration as far as the supply of dazisami that you may be considering, considering that you may not pursue further future studies with dazisami?
Accounting consideration as far as the supply of I say Sami that you may be considering considering back.
And like that you may not pursue further future studies, but those aissami.
No nothing that would be material.
Okay. Thanks for taking my question and congrats and I'm looking forward to seeing the whole team in the near future.
Speaker 4: Okay, that's sort of taken my question and congrats and I'm looking forward to seeing the whole thing in the near future. Thank you.
Thank you for your interest.
Speaker 2: Okay, we had two additional questions, Stephen, that were pre-submitted by investors. First question, there is a lot of business development going on in the pharmaceutical industry. Has NREX been a part of that in some way?
Okay. We had two additional questions Stephen that we're.
Pre submitted by investors.
Great question, there is a lot of business development going on in the pharmaceutical industry.
Is has that <unk> been a part of that in some way.
Well our technology includes components that have not shown addiction potential which is an important differentiator and as a result of that Oh.
Speaker 2: Well, our technology includes components that have not shown addiction potential, which is an important differentiator. As a result of that, our technology, our IP portfolio, have attracted strong interest. And we are in conversations with a number of potential partners.
Our technology, our IP portfolio.
Have attracted strong interest and we are in conversations with a number of potential partners.
Speaker 2: Thank you. Second question, how do you see NRX-101 in comparison to others in the industry, axon and rheumatoid compounds? Those are both in late phase three.
Thank you.
Second question.
<unk> <unk> hundred one in comparison to others in the industry axon umbrella.
Compounds I think those are both in late phase III.
Sure I think I think they're interesting compare a comparator to us.
Speaker 5: Sure. I think they're interesting comparators to us. I believe that they do not study patients with suicidality.
I believe that they do not study patients with Suicidality.
So in essence, they are seeking to develop an approved agent for major depressive treatment resistant.
Speaker 5: So in essence, they're seeking to develop an improved agent for major depressive treatment resistant.
Depression.
Speaker 5: depression. We're focusing on a much higher unmet medical need in the bipolar segment with suicidality and up to 50% of bipolar people.
We're focusing on a much higher unmet medical need and the bipolar segment with Suicidality and up to 50% bipolar people.
Speaker 5: attempting suicide. Hence, we're working on an improved antidepressant that can be used in patients where the other two medicines cannot be used. And we think that, while it's a comparator, is a point of differentiation where we exceed the opportunities in a fairly significant 22 billion dollar market.
Attempting suicide.
Hence we're working on an improved anti depressant that can be used in patients where the other two medicines cannot be used and we think that while it's a comparator is a point of differentiation, where we exceed the opportunities in a fairly significant $22 billion market.
Yeah.
Okay I believe those are the.
Those are the questions we had the operator.
Speaker 1: This concludes our question and answer session. I would like to turn the conference back over to Tom Johnson for any closing remarks. Please go ahead.
This concludes our question and answer session I would like to turn the conference back over to Tom Johnson for any closing remarks.
Go ahead.
Well. Thank you everyone. That's all the time, we have for questions. Today. Thank you for joining US. This morning. This concludes the <unk> Pharmaceuticals second quarter 2022 results conference call. Thanks, everyone for participating this morning.
Speaker 2: Thank you everyone. That's all the time we have for questions today. I'm gonna thank you for joining us this morning. This concludes the NRX Pharmaceuticals second quarter 2022 results conference call. Thanks everyone for participating this morning.
Yeah.
Thank you.
The conference has now conclude thank you for attending today's presentation you may now disconnect.
Speaker 1: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
Yeah.
[music].
Speaker 6: The.