Q2 2023 NRx Pharmaceuticals Inc Earnings Call

Because we really completed our phase III commercial manufacturing program in Q1, we were able to seamlessly introduce these indications to F D. A.

I have more than 1 million doses in medicine in the warehouse.

With which to initiate new programs.

Specifically, we are exploring the use of inter X 101 in chronic pain and post traumatic stress disorder.

Jonathan would you review the science results achieved during Q2 and reflect on our near term goals.

Thank you Steve.

So it's.

He shared with all of you on the phone our near term priority remains the delivery of data for <unk>, one on one and bipolar depression Suicidality.

To trigger the first $10 million milestone payment.

In our partnership agreements.

As you know, we're the first pharmaceutical company to enroll patients with suicidal bipolar depression.

Clinical trial potentially lifesaving oral medicine.

These are patients who have been excluded from the clinical trials the bolt previous anti depressant drugs.

The high risk nature of this population that's required us to take a high level of caution and recruiting selecting and monitoring the care of these vulnerable patients.

In March we advised you that the independent data safety monitoring board identified no safety concerns and no utility and.

And now we're pleased to share with you that no unexpected serious adverse events have occurred in this high risk population.

That's fine.

More importantly.

Clinical trials in psychiatry succeed or fail.

On patient compliance with study medicine.

On the consistency with which depression and other key endpoints are measured from one study site to another.

And that.

So I'm about to talk about our scientifically complex.

We've posted a.

Paper to the pre print servers, which are free to read and reflect on what I'm about to say.

So the quality metrics, we're seeing in terms of study work pension safety medication compliance and rating reliability.

Yeah, but added pumping trial in which we are engaged.

Potential to be the better the drug registration.

Should we pull back.

In other words, we don't know that the drug is going to work, but we do have increased confidence that we're measuring the results of the trial in such a way that.

We will be able to identify it.

Sure.

We track the execution of this trial and a number of ways on a daily and weekly basis.

To share the results to date on where you get the key metric we evaluate.

And we're complying with the prescribed treatment.

Courtney.

The evaluations otherwise known as inter rater reliability.

The study compared to those conducted by the central Raters at our company and lastly patient enrollment.

The first treatment compliance so far in our trial, we've seen greater than 90% compliance with.

Patients prescribed rexam, it's amazing by pill counts of patient visits were encouraged by the high level of compliance as we believe the key to patients experiencing relief from these symptoms.

Now, let's talk about concordance or inter rater reliability.

And how you treat trial theater fail based on their ability to control the accuracy with which the endpoints of the trial are measured in our case those endpoints are relief from depression, and really from suicide Dallas.

During the first quarter of 'twenty to 'twenty, three we refined our ability to validate the metric waiting that are used to with that.

The endpoints.

We rely on a team of veteran psychometric greater master's level or ph D.

Train the Raiders at the independent study sites.

And right and monitor the technical quality of each rate in other words, we get an audio file.

And every cycle metric waiting from the study sites and our in House writers, We review that information to see whether they agree.

With the information obtained by the studies done.

We set a standard that requires to make someone's reported from study sites.

On a patient by patient basis.

Mm three points of the Macerator score on the on the standard 60 point Montgomery Asper depression rating scale or madness.

Raising scale as the primary efficacy endpoint that FDA has required for all recently approved anti depressant drugs.

Please point standard we pre specified in our protocol is substantially stricter than the looser six points standard.

Recommended in the literature, but we felt it was essential to reducing site to site there.

That diminishes.

Reliability.

You bet.

In fact people have often asked how can we obtain typically significant endpoint and the stable beef study with such a small population and we attribute that to really tighten measurements around those endpoints with very low variance.

To be accounted for.

So we also said standard of 90% or better inter rater reliability, which is the measure of what responsive ratings meet that three point standard.

Today, we posted a research report blinded results from the first 50 patients enrolled in our clinical trial and interviews and their primary spoken language document and 94% inter rater reliability.

Of course study sites in other words, we have no idea who's on drug and who was born Lurasidone all we know.

How the ratings obtained in the study site.

Backs up against the ratings obtained from the same patients same audio files biomass the raiders.

Finding substantially theme there prespecified baseline requirements and also has seen the inter rater reliability, that's routinely published in the literature.

Yes.

We believe that this rigorous approach to measuring our primary endpoint is key to being able to successfully proof of efficacy in our clinical trials, but there'll be efficacy to fruit.

In order to meet our objectives, we need the ability to recruit a substantial number of patients over a short period of time.

As we previously noted in April 2023 we contracted with one and help to initiate a recruitment campaign that may cover up to 45 states in the U S.

Recruit sufficient patients for our phase III program.

The company has similarly broadened its previously announced relationship signed 37.

Zero that conduct decentralized clinical trials to enroll participants identified by the one in health initiative and to randomize them to be treated within the broadened clinical trial.

So let me explain that for a SEC and most clinical trials you set up the study sites in particular locations those study sites where crude patients.

Patient they measure the result, but somebody who lives to 100 miles.

50 miles away from our study site is really unable to participate.

Slide 37 has the ability to recruit patients nearly anywhere in the country and send a team of nurses to their door.

In order to administer the investigational medicine in order to make sure the endpoints of the study so that our dependence on brick and mortar study site is substantially the meda.

And now one in health has additionally engaged the mighty a voice of the patient organization with National reach publicize that clinical trial is there 800000, plus subscribers, who have indicated a personal focus on bipolar depression and suicide Dallas.

And all of you on the phone or are you're welcome to read the lay press articles that the mighty is sharing with the bipolar community.

So based on these broad coordinated efforts, we expect that data will be available near year end of 2023 to.

To meet the Albertson miles there.

As you know we began talking to public investors about and our X 101, and March 2022 on the tail of the Covid pandemic.

While we've explained the potential impact of our combined formulation of these sites are staring in la Raza, one for bipolar depression.

It's also important to recognize the broader applications of this drug class combination.

In Iraq, we discovered the unique synergies between M D E and five H T two way targeting drugs.

Two different chemical receptors in the brain.

Typically that each components.

Secondly blocks the potential adverse events.

Of the other creating a potent therapy with an advantageous safety profile. Additionally, we've identified and patented the critical doses.

<unk> D serine navy effective in various conditions.

These discoveries are at the core of our company and at the core of our MGA platform.

These discoveries have resulted in a portfolio of 90 patents around the world 48 of which have not been issue related to the treatment of bipolar depression.

Major depressive disorder, PTSD and other central nervous system conditions.

No. The Albertson agreement anticipates that N Rx will develop additional products containing these type of exterran or other M. D. A antagonist in combination with one or more anti depressants anti psychotic ingredients for use outside the field of bipolar depression with suicidal.

Chronic pain with or without depression, and post traumatic stress disorder or PTSD.

Last week, we announced the licensure for.

First our apcar carrying patents for the use of these types of staring in the treatment of chronic pain.

There are approximately 7 million Americans, who live with bipolar disorder episodes of depression and.

In contrast, more than 50 million Americans live with chronic pain.

Those with bipolar depression suicidal reality have no approved treatment of you been electric shock there.

Who live with chronic pain are frequently dependence on opioid based medications the risks of what should become practically visible for all over the past few years.

Just a few weeks ago, the White House announced that 165000 Americans die from opioid annually.

We've now posted a paper to the scientific literature, which you can see on our website.

Documenting more than 20 years of research, which demonstrates extensive non clinical and early clinical evidence that these cyclical theory interrupt the pain pathway at each step between the peripheral pain sensors and the central nervous system.

Potentially decreasing craving for opioid and those who are afflicted with chronic pain.

We've recently published peer reviewed studies documenting that Eric 101, he's not neurotoxic and is not addictive.

We believe that chronic pain affords a unique opportunity for <unk> 101 and for our shareholders.

When we began our work in bipolar depression opioids were dominant and widely accepted treatment for chronic pain.

That time market wisdom suggested that non addictive innovative analgesic drugs could not compete effectively with generic opioids.

Good day.

Situations quite a bit.

Today, an overwhelming shift in public health policy and public awareness that's reflected in the popular press recent TV series and multi jurisdictional litigation documents a widespread movement against the use of opioids and creates a unique opportunity for non addictive.

Non neurotoxic treatments for chronic pain.

Establish yell at me 2 billion dollar market that is expected to grow to more than 100 billion by 'twenty three.

Of key importance is the recognition by the U S Department of Defense of the 2016 study published by Northwestern University Research group that identified a statistically significant reduction in pain scores at a 400 milligram daily dose of besides the theory.

That's the threshold dose, but also predicted in our patent portfolio.

The D O D asked about this finding by funding a 5 million dollar Congressionally directed Medical Research Program Award the Northwestern University studied these types of sharing and several hundred patients with chronic pain.

Shown on clinical trials Gov patient recruitment in this trial is complete.

And study results are anticipated in the near future.

A large public investment in chronic pain therapy complete.

Completely non dilutive to our shareholders using the key ingredients of our drug, namely D. Serine already has the potential to provide a rapid path to drug approval for the efficacy would be shown.

The lurasidone components of our drug May also independently treat chronic pain.

As previously announced we completed our phase three and commercial manufacturing program for inner X one on one.

This week, we're opening an investigational new drug filed with the F D. A.

Our use of in our X 101 to treat chronic pain.

The rationale for treatment of chronic pain would be stuck with Ferring is outlined in our review article that we've recently posted and is on our website and in the 2016 scientific paper published by Professor Smith, there are carrying in their coworkers.

In brief East Islip, serine, which act as an M D a antagonist drug above threshold doses.

Demonstrated extensive non clinical and early clinical efficacy in one decreasing their response been no susceptive pain that is the pain, that's triggered by pain receptors in the body and to decreasing craving for opioid drugs with evidence that D. C. S is both.

Non addictive and non neurotoxin.

Regarding post traumatic stress disorder or PTSD, we previously identified the rationale for treating PTSD with M D a antagonist drug.

<unk> shared with you evidence that D. C. S decreases the pure memory associated with PTSD in non clinical studies, we plan to investigate in our X 101 in PTSD as an additional indication and to commence planning for that phase two clinical trial in 2012.

Trade.

In summary, I believe our progress this quarter solidifies, our ability to reach patients with suicidal bipolar depression.

While the results of our ongoing trial remains blinded we've shown scientific evidence that the trial is being effectively executed and rigorously monitored.

Additionally, our chronic pain program has expanded the company's market opportunity tenfold and position the company for future growth with near term data Readouts are programs address more than $100 billion in market opportunity.

Serving patients with significant unmet medical needs as always I'd like to express my gratitude to the patients the <unk> team.

Clinical trial investigators and most importantly, you were shareholders for your continued support.

It's been Borys will now discuss our financial performance.

Thank you Jonathan and good afternoon, everyone I will now review the highlights for second quarter 2023 financial results.

In June the company raised $6 3 million and a registered direct offering and negotiated an amendment with street, a real capital the company's current debt holder to address the company's current debt facility to best support the ongoing needs with the clinical trial.

The amendment targets, reducing our monthly redemptions the loan to $400000 per month through year end 2023.

For the three months ended June 30 of 2023, and there were extra recorded $3 9 million of R&D expenses compared to 3 million for the three months ended June 30th 2022.

The increase was related primarily to an increase clinical trial enrollment in our <unk>.

Ongoing phase two b three trial.

For the same three month period, we recorded a 38% reduction in general and administrative expenses from $6 6 million in the second quarter of 2022 to $4 1 million for the three months ended June 32023.

The decrease of 2.5 million is related primarily to decrease in legal insurance and accounting cost.

The six month period from January through June of 2023. Similarly shows decreased expenditures as reflected in our financial statement compared to the prior year.

As of June 32023, we had $15 million in cash and cash equivalents.

Use of working capital assets are expected to fund the company's operations through the fourth quarter of this year, which is <unk>, which is the expected delivery of data for our phase <unk> three trial.

Additionally, we are evaluating operational efficiencies to extend this runway.

With that I'll turn it back to Steve for closing remarks.

Steve.

Thanks Seth.

2023 has been an incredibly productive so far and we look forward to advancing our N M D. A platform in general and specifically our in our X 101 program and suicidal bipolar depression with their partners at Albert.

As well as a very exciting chronic pain program all in the near term, we believe that our X 101, as a potentially life saving medicine that could change the treatment paradigm for a wide range of serious and life threatening conditions, which is the driving force behind our mission of meeting the needs of these underserved.

Patients.

With a shared commitment of our investors our team and our researchers we aim to bring hope to life for the millions of patients who may benefit from our unique products.

Operator, we're ready to take questions from the audience.

Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.

If youre using a speakerphone please pick up your handset before pressing the keys and took draw. Your question. Please press Star then two and at this time, we'll pause momentarily to assemble our roster.

Yes.

Yeah.

Yeah.

Operator, we've received a couple of written questions that I'll proceed with now.

This one is for the company how is the partnership with Allergan going so far.

Yeah.

I think this is really very well, we we had a.

200 executive meeting in person the last week of the teams are melding well.

I think it's gone very well.

Okay. Thanks.

One is for Dr. Javad, how potent do you believe recycling theory and interacts 101, maybe in treating chronic pain.

Please let me hear the question again I didn't hear the second word.

Alright.

Potent do you believe he's.

He's like with Syrian interacts 101, maybe in chronic pain.

Well, if you look at the 2016 publication by Smith and carrying on their coworkers.

The reduction seen in treating chronic pain was certainly deem clinically meaningful.

It's a reduction that is probably larger than what you can obtain from non opioid pain medicine.

And may even be comparable to what you can obtain from safe doses of opioids. Since we're gonna know an awful lot more when the D. O D trial reads out because.

That's a couple of hundred patients treated over 12 weeks.

But there's reason to hope.

That.

N M D a antagonist drug maybe quite potent and Sac N.

Anesthesiologists already treat chronic pain with IV Academy of course recognize that to get out of the ketamine.

You've got to be in a hospital environment.

It's not a simple process.

There's no question that M D a N pegging growth.

Block.

The pain pathway at each step there were three nerve cells that go between your finger kept in your frontal cortex.

And at each step the connection between nerve cells. He is regulated by the NMDA receptor.

Okay.

Can you hear him and another question can you talk a little bit about the patients who are coming into the phase three study, how they're doing and are they continuing through the trial and how that's going sort of in the big picture.

Yeah.

Well I think we shared just about everything we can.

In the context of a randomized double blind trial.

We're steadily enrolling patients.

We're doing it with a great degree of caution so far has been.

Ah study site will identify patients as potentially eligible.

To review the eligibility criteria with US ahead of enrolling the patients and then they'll sit messy audio files of the mattress score raising session that suicide reality raising sessions.

And our in House Master Raiders will validate those sports before somebody gets into the clinical trial.

But I think we're being as careful as we can possibly be about who gets in.

And how the primary and secondary endpoints of ascertained.

Once they're in the trial.

Sure.

Very good.

Written question that we've received can.

Can you talk about the Genesis of the Department of Defense study in there.

With recycled sharing and the Genesis of the larger trial.

Picture around that.

Well, we had nothing to do with the department of Defense study.

So just as.

Dan do you have at the co founder of this company again.

Gauging was the secretary and there is a potential anti depressant drugs.

<unk> 2004.

Professor are carrying and his co workers.

Similarly.

Again studying the potential for these types of theory.

He used to treat chronic pain.

Developed a a substantial basic science space, which is cited in the review paper that we posted for you.

And they perform that first 40 person trial, which yielded.

The positive result, but the trial itself was not deemed to have.

<unk> met its primary endpoint because based.

They studied patients at 50 milligrams 100 milligrams 200 milligrams and 400 milligrams that these types of sharing and they didn't see a benefit across all of those doses. They saw a statistically significant benefit only at the highest dose.

They reported that out in 2016 and they apply to the department of Defense, who responded with a $5 million grants to do a larger confirmatory trial.

We don't know any more about that trial and is available to the public you can read about it on clinical trials that go up but.

But we do know that David collection is complete in the study.

Is anticipating a readout this year.

So we're very excited that the study happen.

And we're making plans to initiate.

Registration study.

Should that study a yield a positive readout.

Okay. Thank you.

The next question will come from Ed Woo with <unk> capital. Please go ahead.

Yeah. Congratulations on the progress my question is on the partnership that you guys are found recently with notice an L. But yet a lot of it is obviously very strong in Asia. How much efforts are going to be doing to expand you know are these drugs into Asia or is it pretty much just focus on U S approval first before you move.

Moving to Asia. Thank you.

Thanks for that question that I think it's significant.

Lotus is a full partner in this because they are very strong in Asia.

I think as we go through.

Two the phase three trial and get closer to commercialization. Some of those decisions will be made but I know that for example in our meetings on.

On the commercial side mm Lotus is always present at the table.

And I think that but.

Dwell for a major effort in it.

Asia as well as in the U S.

That said of course, the U S is a much larger market for the product.

Great well. Thank you for answering my questions and I wish you guys. Good luck. Thank you. Thank you.

Again, if you have a question. Please press Star then one.

Yeah.

Yeah.

Yeah.

This concludes our question and answer session I would like to turn the conference back over to Mr. Steve Willard for any closing remarks. Please go ahead Sir.

Thank you very much and we very much appreciate your interest in an IMAX pharmaceuticals.

Thank you for listening to our presentation and it's very exciting quarter.

We'd hope that you will follow as closely in the weeks and months to come.

Thank you very much.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

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Yeah.

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