Q3 2023 NRx Pharmaceuticals Inc Earnings Call
Thank you for standing by this is the conference operator, welcome to the generics Pharmaceuticals third quarter 2023 earnings conference call. As a reminder, all participants are in listen only mode and the conference is being recorded after the presentation. There will be an opportunity to ask questions to joined the quest.
In Q you May Press Star then one on your telephone keypad should you need assistance during the conference call you May signal, an operator by pressing star Zero I would now like to turn the conference over to Matthew Duffy Chief Business Officer. Please go ahead.
Thank you Ashley and welcome everyone. 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 precedent experience or present expectations.
Additional information concerning factors that could cause actual results to differ from the 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 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 yesterday and in the company's Form 10-Q filed earlier today.
Which may be accessed from the investors page Onthe interacts pharmaceutical incorporated website.
Joining me today on today's call are.
Stephen Willard Chief Executive Officer.
Dr. Jonathan <unk>, our founder and Chief scientist Mr.
Your Doritos, Chief Financial Officer and Treasurer.
Steven and Jonathan will provide a summary of the Companys progress Rich will review the company's financial results.
And then Steven will review upcoming milestones before making closing comments.
Following their prepared remarks, we will address investor questions.
Yeah.
I'll now turn the call over to Steve Steve.
Thank you Matt.
Good afternoon, everyone and thank you for joining us.
The third quarter represents a potential turning point for our company as we are approaching our clinical trial enrollment goals.
Partnered foundation product in there, it's 101, while opening new clinical initiatives in chronic pain urinary tract infection.
Our X 100 for suicide and depression.
We expect for potential upcoming milestones.
First our core clinical trial, and our X 101 for treatment resistant bipolar depression suicidality.
Second the near term readout, because the department of defense funded clinical trial.
With CRE and for chronic pain.
Third alright program to take a new drug approval for intravenous Academy, which we have designated in our X 100, and establish that drug in a new personally capitalized company that aims to be cash flow positive by year end 2024.
And for the near term approval of our investigational new drug application and award a qualified infectious disease product classification.
101 in complicated urinary tract infection.
It is called Cdti.
Any one of those guys.
But that's like unlock substantial shareholder value.
More than one trial has the potential to unlock exponential growth.
I am incredibly proud of our team our collaborators and partners and most of all the patients who have made such an important contribution to these efforts.
All of us at <unk> are deeply grateful to the many shareholders who have reached out to us encouraged us and supported us.
Period of immense challenge in the biotechnology market.
Together, we are pursuing <unk> goal of bringing hope to life on a daily basis.
Now I would like to invite Dr. Jonathan <unk>, our chief scientist.
Our clinical development program.
Thank you Steve.
Let's lead off with our foundational program around and our X one one for suicidal bipolar depression.
We restarted the program in March 2022 on the tail of people dependent.
And the subsequent 18 months when we transferred our manufacturing to the U S gained SBA alignment for our CNC instability program manufacture approximately 1 million capsules within our X one on one and relaunched our clinical program.
We're excited to announce today that the company is near completing enrollment of the originally targeted 70 patients in the phase to be treat trial.
Believe that as of yesterday, the number was 69.
We decided to continue enrollment through the end of the month and to target 74, Evaluable patients randomized to interact 101 versus standard of care medicine.
The results of this trial have the potential to be used for Registrational pilots just target population based on the company's January 2023 meeting with the FDA in which the company was guided to expand its intended use of interacts 101 from the original population of patients with acute suicide delegate who might be.
Treated in the hospital environment for the broader population of patients with sub acute suicidal ideation, which we now describe as treatment resistant bipolar depression in other words patients who were treated in the outpatient setting.
Based on the guidance of the FDA and the company's completion of manufacturing for phase III commercial stage investigational product, we upgraded the ongoing clinical trial to a phase <unk> trial earlier this year.
In our last call I shared with you the steps we've taken to set a new standard for reliability of the mattress that is the Montgomery Aspirin depression rating scale measurements in trials such as this the major scale is our primary endpoint in this study and then virtually all industry depression.
Studies the industry has previously accepted at six point disparity between psychometric graders at study sites and Masturbators, who checks those evaluations. Moreover, the industry is often settle for comparing only the baseline readings between site readers and master agents over the past.
Last year, several clinical trials of promising investigational medicine for depression failed. So we decided to set a far more rigorous standard.
First we set our standards for agreement between the sites and the master readers and three points of difference on the 60 point rating scale, rather than six points of difference.
We decided to acquire 90% agreement.
And that's the Raiders in order to keep the site and the progress.
Third we decided to check the agreement on every patient rating not just the baseline rate.
As of today I'm pleased to tell you that our clinical team has maintained 95% agreement between study sites and master range that doesn't mean that our drug will work. It still has to be the standard of care. It does mean, however that we have markedly increase the chance of determining a deferred.
Between the drug group and the standard of care.
In our last call I shared with you the steps that we took to implement a nationwide recruiting strategy with one and health that investment paid off with a substantially celebration in our enrollment rate over the past quarter, a capability that will serve us well should the drug demonstrated efficacy in this upcoming readout.
Also on that last call I described the advances we made in manufacturer van are excellent and one resulting in more than a million commercial grade capsules and our warehouse product stability work has continued to support the targeted two year plus shelf life as potential drug launch.
In other words at such time as the drug is approved we intend to be immediately ready to ship. It to patients as you know last June we entered into an exclusive global development supply marketing and license agreement with Allergan incorporated an affiliated company.
Thanks.
Albert Chen will pay interacts with $10 million milestone.
Upon delivery of positive phase <unk> results and the Ftes concurrence followed by age you know.
$330 million of additional milestones and royalties of up to 15%.
Further our Virginia assumes essentially all development and commercialization costs associated with this indication from that point forward.
The company has solidified its working relationship with al Virgin over the last quarter, we've begun working in unison to plan the final development and commercialization of <unk> 101.
Based on the milestones achieved during this quarter.
101 project is on track for completion of a pivotal trial in coordination with a commercial stage partner in less than two years from its re initiation in March 2022.
So now let's talk about <unk> hundred one for chronic pain, that's an indication that we only began talking to you about about.
About a quarter ago. The company has previously detailed the scientific basis for treatment of chronic pain with these types of sharing as outlined in our 2016 scientific paper published by Dr. Cninsure and his colleagues and then the white paper that we posted on our website and on the scientific surplus.
In the third quarter, we licensed the U S patent for the use of diesel with sharing in treating chronic pain and now we've filed an investigational new drug application was accepted by the FDA to initiate commercial drug development have been our X 101.
King.
As you know chronic pain effect more than 15 million American adults compared to the approximately 3 million, who report thoughts of suicide on an annual basis.
Theres been no new non opioid class of drugs to treat nociceptive pain.
That's team that's caused by stimulation of peripheral nerves, such as low back pain knee pain that most common pain that people talk about in the past two decades, and Eric's 101 has the potential to be the first M. D. A antagonist drug to seek approval for this indication.
Today Ketamine is used off label to treat notes susceptor pain, despite its clear limitations, which we described as addiction neurotoxicity hallucination and the need for IV administration.
We now await results with 200 personal randomized prospective trial funded by the U S Department of defense in which patients with chronic pain were randomly assigned to 400 milligrams, a day of diesel with sharing versus placebo.
The investigators have identified primary completion of this trials occurring this month.
We've received a communication from the investors yesterday that the investigational review Board has cleared the study database for analysis and the study statisticians are now beginning their final work.
Should these trials trial result support efficacy of D. C. S. In the treatment of chronic low back pain. The results are expected to provide a breakthrough therapy path towards treatment of chronic pain with these Texas serine M. D C S containing medicines.
Today, we're announcing that we've entered and our X 101 for consideration by the multibillion dollar National Institute of Health Heal initiative, it's a T. A L and its national consortium of clinical trial sites known as epic.
This initiative was funded by the U S Congress.
<unk> innovative non opioid pain medicines.
For chronic pain, we believe that in our X. One on one represents the first M. D. A targeted non addictive medicine to be offered to this program should.
Should the D. O D funded trial yielded encouraging data, we anticipate that non dilutive sources of capital will be available to us given the national focus on the opioid crisis progress in treating chronic pain within our excellent one may open a far larger market for inter X 101 than anything we've talked about.
Related to the psychiatry indications.
Now, let's discuss our other M D a targeted therapy.
And our X 100, which is a proprietary presentation of IV ketamine for suicidal depression.
Prior to this past quarter.
We didn't.
Hard times this initiative, because frankly, we expected intranasal, we're seeing academy to demonstrate efficacy in reducing suicides ality in depressed patients.
Unfortunately, the intranasal drug failed two months ago in clinical trials in patients for suicidal ideation. That's a drug that's obviously not connected to our company Intranasal Academy previously failed for the treatment of chronic pain in 2006.
So in our view the manner in which ketamine is absorbed through the nose may be fundamentally different from its effect as an IV drug.
When we met with FDA in January 2023.
The agency strongly encouraged us to develop ketamine is a label drug rather than rely on prior stabilization of suicide and depression that's achieved.
What are the common clinical practice through today's clinical practice of infusing generic ketamine, that's compounded and licensed pharmacies.
Shortly thereafter, the FDA issued the first of two advisory letters.
Warning against the practice of compounding of Ketamine and FCA began a program of rigorous inspections of compounding pharmacies significantly upgrading the standards that FDA requires.
And forcing some pharmacies to close.
The challenge we faced in responding to Fda's guidance is that a definitive trial of IV ketamine in large numbers of patients with acute suicidology is far more complex and extensive and it could be achieved by small companies such as ours. Moreover, it would take an additional two to three years.
Indeed.
No U S entity has performed a large clinical trial or a multicenter clinical trial of ketamine and suicidal patience.
Fortunately however, the government of France did invest in such a trial starting in 2015 of trials conducted in seven French psychiatric hospitals, among 156 patients with acute suicide alloy. So based on the Fca's advice on ketamine, we established the scientific collaboration.
With professor Marianne Leboyer of Inserm, one of France's leading universities and professor <unk> Crown a bar of Leon France.
Under which we gained government support to obtain the patient level results from their groundbreaking trial and to.
Submit those results to S. P a and support of a new drug approval for intravenous Academy.
As you have seen in our presentations the findings of the trial demonstrated an overwhelmingly positive statistically significant reduction in both suicide Ality. The primary endpoint of the trial and depression.
Secondary endpoint among patients treated with intravenous ketamine compared to those treated with placebo.
The patient level de identified data from France had not been received by our team of statisticians and are being assembled in the electronic format required for submission to the FDA today I'm pleased to share that the company is now negotiating access and here is a preliminary agreement.
Confirmatory patient level data from a U S based trial performed at a leading university and funded by the National Institutes of health.
Having taken advice from our regulatory legal consultants, we believe that these two multicenter randomized prospective trials that encompass more than 240 participants combined with randomized prospective data on more than 200 U S patients when submitted for a view.
Provide evidence of safety and efficacy of intravenous ketamine in reducing both suicide reality and depression.
Long suicidal patients, we expect to transmit those data to FDA by the end of the quarter.
Although the biotech industry rightly focuses on safety and efficacy is key to securing drug approval submission of an NDA for the use of IV ketamine. It's also dependent on documenting the manufacturer in packaging.
The new drug presentation, and a long term shelf stable manner with control of them purity and other hallmarks of good manufacturing practices. Indeed.
Indeed phase III biotechnology products are often delayed by unexpected manufacturing failures, perhaps more often than by unexpected clinical trial results.
That's why we're excited to announce the signing of the of the development and manufacturing agreement with Nephron Pharmaceuticals incorporated to develop a single patient presentation of Academy, that's expected to overcome some of the formulation deficiencies of existing forms of ketamine that were originally developed for them.
Anesthesia and is expected to have diversion resistance and tamper resistant features we believe this latter aspect is important because of the well known uses of ketamine as the drugs of abuse and also as a vehicle for daily.
We've worked with nephron in its visionary founder and owner of loot Kennedy on previous projects.
I have great confidence in the nephron team in this case Neff, Ryan is particularly suited as a partner because of their enormous investment in sterile blow fill seal technology is ideally suited to our planned commercial presentation.
Our current timelines project submission of a new drug application for ketamine in the first quarter of 2024 with a targeted paducah date.
In the fourth quarter of 2024.
Now, we don't anticipate funding the ketamine initiative with core and Rx assets.
And our.
Our guidance in today's queue.
Advisors investors the bar plan to establish a ketamine focused spinoff company that will potentially provide current and new investors with both capital appreciation and a royalty stream.
Last week, we received a term sheet for up to $30 million in.
Financing for this new business sensitive.
In this plan a portion of the equity to be built in the academy the asset will be allocated to existing shareholders as of our record date to be established potentially with an ongoing royalty stream to in Iraq.
Those shareholders and to the new investors <unk>.
She will be discussed at the upcoming annual meeting of shareholders, which we hope all of you will attend.
Like acute public health need for safely manufactured diversion and abuse resistant form of ketamine.
Literally in light of drug shortages caused by newly and appropriately rigorous FDA manufacturing standards.
<unk> anticipates pursuing a near term potential solution to address the public health need by the end of 'twenty 'twenty four.
Finally, we expect that our focus on urinary tract infection is a bit surprising.
Given our identity as the CNS.
As a company.
Although treatment of UTI is quite different from the use of NR exelon and want to treat.
Central nervous system disorders. These types of Stern was originally developed as an antibiotic.
Because of its role in disrupting the cell wall of certain bacteria.
No surprise when was that May sound, that's true of a number of drugs used in psychiatry today. They all began as antibiotics.
These type of Syrian fell out of favor as an antibiotic in the 19 seventies.
Cause the CNS effects caused by its NMDA, Boston properties and because of the widespread availability of effective first and second generation antibiotics.
However, D C S as unique as an antibiotic and that it's nearly 100% and screening unmetabolized and the Europe and therefore, it achieves high urinary track levels with oral administration.
You probably know many of the newer third and fourth generation antibiotics require intravenous administration to treat complicated UTI.
Our clinical experience and satiety, which suggests that the lurasidone component of an Rx 101 blocks unwanted CNS side effects and unlocks the potential of the cyclic staring to treat antibiotic resistant.
Ordinary tract infections.
With a decreased propensity to cause unwanted CNS effects.
In recent years increased antibiotic resistance.
Common pathogens that cause urinary tract infections and Europe sepsis.
In other words stuffs that originates in the urinary tract has resulted in a market increase in complicated urinary tract infection hospitalization and death from your acceptance.
Everyone on this call knows someone who has developed a UTI and ended up receiving IV antibiotics in the hospital or at home.
The U S center for disease control and prevention reports that more than $1 7 million Americans contract. That's the C. G. Eight of whom are at least 350000 die during their hospitalization or discharged to hospice.
In 2015, Dcs was demonstrated to be effective against pathogens that are increasingly likely to close sepsis and increasingly resistant to first and second line antibiotics.
In Q3, we tested the indirect one on one and its components against resistant pathogens that appear on the congressionally mandated qualified infectious disease product list and.
And we proved in vitro effectiveness that his effectiveness in the laboratory against antibiotic resistant E coli, Pseudomonas and acinetobacter ease or bugs that kill patients every day.
And in vitro effectiveness is what's required to meet the requirements of the <unk> program.
Qualification for Q I D. P affords the sponsor five years of additional market exclusivity from F. D. A regardless of whether or not you have a patent on the drug.
And we do have a composition of matter patent on the interacts 101, together with fast track designation and priority review.
We believe that <unk> one on one is an oral medicine has the potential to demonstrate benefit in patients who would otherwise require intravenous third and fourth generation antibiotics.
We believe there are approximately 3 million such patients a year who.
Contract with complicated UTI.
Sure and our excellent one succeeds in clinical trials. The company has a plan follow on product that's anticipated to achieve another 20 years of patent exclusivity.
Based on the in vitro study that we performed we now have submitted an investigational new drug application requesting <unk> status fast track designation and priority review from the F. T. A we're expecting the FDA to approve the cyan D by the end of this year.
By the end of 2023.
I just want to Ketamine development project, we don't anticipate funding this initiative with core interest assets and we're exploring structures for a new entity that would provide current and new investors.
Capital appreciation and the royalty stream.
However, the cost of bringing in our X 101. The market is an antibiotic is far lower than one might imagine because we've already manufactured the drug we already have the necessary preclinical safety toxicity pharmacokinetics pharmacodynamics data in our.
Hans from our bipolar program.
We've already begun conversations with investor groups, who recognize the extraordinary public health need.
The company succeed in serving 10% of the CGI market, but we believe the revenue from an excellent one for this indication has the potential to reach hundreds of millions of dollars annually based on 3 million cases per year in the U S.
Finally, I'd like to address the challenging issue, it's frequently raised with us by investors investors have contact with us with the belief that the company's share price may be adversely affected by short sales of stock that may frequently accompany positive news well.
While coverage short sales such as those sales better associated with borrowing and existing share of stock.
Our legal naked shorting without an underlying barge share is clearly illegal importantly, our recent federal court decision holds brokerages liable for damages to companies associated with persistent naked short positions.
Based on these queries from investors in Q3, we contracted with share Intel incorporated to examine disparities between Eric stock positions as reported by Brokerages and Eric shares reported by D. T C electronic clearinghouse for the NASDAQ exchange.
Today, we're announcing that persistent disparities of approximately a million to a million and a half shares were identified in other words those may be naked short positions. The company has now instructed the council to initiate outreach to compliance departments of the identified.
Identifying that all uncovered short positions in the company stock be closed.
Our first delivery of shares.
The company has been advised by counsel that this action has resulted in positive share action in the past when implemented by other issuers of NASDAQ stock.
Now I'm going to ask rich no read or Chief financial Officer to review the third quarter financials rich.
Thank you Jonathan and good afternoon, everyone I will now review the highlights of our third quarter 2020 financial result.
Before reviewing the numbers, it's important to recognize that we have consistently reduced.
Our cash expenditures and expect to further reduce those expenditures as.
As we complete the NR right 401 clinical trial.
In August the company entered into a securities purchase agreement pursuant to which the company issued 3 million shares of the company's series a convertible preferred stock.
One investor a warrant for every share what triggers a preferred stock issue.
The aggregate proceeds of the company from the private placement.
Proximately, one quite a few million dollars before it.
The company intends to use the net proceeds from such offering for working capital and general corporate purposes.
For the three months ended September 30 of 2023.
And the right form of physical three quarter $3.3 million of research and development expenses compared to $4 1 million for the three months ended September 32022.
The decrease is related primarily preclinical development expenses and fees paid to regulatory and product development.
For the same three months period, we recorded a 50% reduction in general and administrative expenses from the $5 million.
Third quarter of 2022 to $2 $5 million for three months ended Sept.
According to 2023.
The decrease of $2 $5 million related primarily to pick pieces of employee related expenses.
Legal insurance and accounting costs.
The nine month period from January through September 20th century. Similarly shows decreased expenditures as reflected in our credential statements compared to the prior year.
As of September 30 of 2023, we had $8 $9 million in cash and cash equivalents.
These working capital assets are expected to fund the company's operations.
Or do you expect that she met cover four key topics for today.
Additionally, we are evaluating operational efficiencies associated with the completion of manufacturing activities.
We're on the way.
With that I will turn it back to Steve for closing remarks.
Thanks Rich.
And the next several months, we expect to see multiple efforts in Iraq come to fruition.
We believe may provide significant upside to our investors.
We're near completion of enrollment in our suicidal bipolar depression trial with <unk> 101, and are moving toward data early next year.
We await data from northwestern University's Department of Defense funded trial in chronic pain.
We expect to receive a response from FDA on our qualified.
Breakfast disease product request for an Rx 101, and urinary tract infection, and we expect to position and our X 100, and a new entity to file an NDA for IV Academy and suicide and depression in the first part of next year.
Investors have expressed some concern about whether we will maintain compliance with NASDAQ listing requirements. We are working closely with NASDAQ, Sir and outside consultants in that regard and.
And we said in our 8-K filing or treating any years before milestone for identified about has the potential to look at our stock price range required by Medicare.
And those milestones play out we will continue to act in a manner that is most supportive of our shareholders.
For small biotechnology company, we have a tremendous amount of opportunity.
Shareholder value, arriving in the near term.
I'm incredibly proud of our team our collaborators and partners and first of all the patients who have made such an important contribution to these effort.
Together, we are pursuing and our exit coal.
Oh God lives on a daily basis.
Operator, we are ready to take questions.
Thank you we will now begin the question and answer session to join the question queue. You May Press Star then one on the telephone keypad, you will hear a tone acknowledging your request.
Using a speakerphone please pick up your handset before pressing any keys to withdraw your question. Please press Star then two.
Yeah.
The first question comes from Andrew <unk> with S. N DN capital. Please go ahead.
Thank you for taking my question. My question is you know as you guys start pursuing opportunities with quantity and infectious disease Oh cause this.
Your partnership with logos or al Virgin and do they have any opportunities to have first rights to get involved with this with you.
There is a rider. Thank you Ed there is it right at first negotiation.
Not a writer first refusal.
Great and what kind of a negotiation process and when do they have to make a decision process or is it something that's going to be ongoing what your clinical trials.
I believe the.
It will be ongoing.
But I believe that they have 10 days from when we.
To make a proposal to give us a decision.
And then were free to.
Partner the product right.
Ways that are no less favorable to <unk>.
Great. Thank you for providing the question answers my question. Thank you and I wish you guys. Good luck.
Okay.
Yeah.
Actually I have ever seen this is Matt Duffy and I have received some electronic questions.
For for for management here. The first one I think it would go to Steven.
Looks like it dovetails off that last one which is.
How is the partnership with Allergan going so far in general.
I think it's going really well I mean I.
Have a good working relationship with the CEO of Allergan, we've established a number of committees.
Meet regularly.
And it seems like we're generally.
<unk> alignment on our goals for development and commercialization of the product.
Okay.
Okay, great another.
Another question came in I think for a Doctor Javett can you tell us more about your plans for the ketamine spin off these assets potential funding benefit to interact shareholders.
Well I think it's important to start out by understanding the challenge that.
Yeah.
That we have we're.
On one hand, we've been working for many years to develop an Rx 101, it's a core asset.
A drug that could readily be worth.
Multiple billions of dollars if it succeeds in clinical trials.
Compared to the projects in our Academy and complicated UTI.
While they were enormously attractive and they are nearer term in terms of their opportunity.
Ultimately there there are smaller revenue opportunity.
But very meaningful revenue opportunities I imagine for example, if.
If you know ketamine like generated $100 million of your profit well, if you're talking about a company like ours.
And its current cap table, that's more than a dollar a share.
So.
They're enormously attractive opportunities for shareholders and at the same time.
Creating dilution within the core company.
Wouldn't make all that much sense for shareholders and that's why in our view.
The most attractive opportunity for our current shareholders is to create these spin offs, where we've already seen appetite.
From new investors to come in and help fund the spin offs.
Do it in a way that current investors will benefit in proportion to their current shareholders now we can't talk too much about the details because that's something that's going to be part of our upcoming annual meeting and deliberation with our shareholders.
That's the general reason for thinking about the spin off structure.
Okay and sticking with the IV Ketamine one other question is it's more a clinical one for you I think Dr. Javad.
Cause IV academy really that much better than inhaled.
Well, we know from extensive literature and now from two.
Well controlled randomized prospective trials.
Ivy Ketamine works against acute suicide Dallas.
And in health Ketamine has never demonstrated that.
And a large multicenter trial.
What's important to recognize is that when you give ketamine Ivy you know exactly what your blood levels are at every moment of the infusion.
When you put ketamine in the nose, you get an immediate Spike Academy.
I would buy a tailing off.
And you have a much less stable blood level, but more importantly, just because you put ketamine in the nose, you don't really know.
How it's going to get into the bloodstream of any individual patient.
Some will go down the back of the throat into the stomach can get absorbed.
Some may go across the tissues of the nose directly into the bloodstream.
And it's going to vary patient by patient, it's going to vary in terms of how the.
Nasal.
The administration has carried out and in fact.
You wind up in a situation, where you're creating a drug device combination with a nasal spray or that has to be regulated as a medical device.
So.
Nathan Ketamine has a history of disappointing industry in 2006, there was a major failure associated with the clinical trials for nasal ketamine in treatment of chronic pain.
So from our perspective.
I V. Ketamine is something that's ready for the market, it's being used widely off label, it's essentially become a national standard of care.
And we believe that an F D a labeled.
Tamper resistant diversion resistant form of ketamine, that's manufactured to current standards not just the standards that were in place when ketamine was developed as an anesthetic, but manufactured to current standards.
It's an important public health initiatives.
And that's why we've chosen to embrace it.
Okay very good thanks.
We have time for one more question.
It is the department of Defense study contained as positive.
What do you see as the clinical and regulatory pathway for <unk> hundred one in pain.
Well, we've already filed an investigational new drug application with the FDA for the use of <unk> hundred one in pain.
And received an enthusiastic response or a response that we've deemed as enthusiastic from the F. D. A division of anesthesia analgesia and addiction products, which is the division that regulates pain.
Hain products.
Clearly if the D. O D trial is positive that would be a critical piece of evidence what additional randomized controlled trials with an Rx one on one and the commercial presentation would be required.
We've talked about some of the non dilutive capital that's available not only through the NIH, but we would expect that the department of defense.
Wouldn't want to continue.
Development of this drug because.
The there's such an acute need within D O D and elsewhere for a non addictive non opioid pain.
Pain medications.
And certainly.
A major initiative in chronic pain would require a capital raise from and are Exorcised what were we.
We have ample belief that that capital would be available.
In the face of a positive read out in the 200 person trial.
Okay. Thank you very much. Thank you everyone. That's all the time, we have for questions Tonight.
We appreciate you joining us let's talk about our journey, reaching these important milestones for the company over the coming months and look forward to your participation in future calls.
This concludes the Hatteras Pharmaceuticals third quarter conference call.
You all for participating.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.
Okay.
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Uh huh.
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