Q2 2023 Virios Therapeutics Inc Earnings Call
Good day and welcome to the Cereals Therapeutics, Inc, Q2, 2023 earnings update.
At this time, all participants have been placed in a listen only mode.
Please be advised that today's call is being recorded at the company's request at this time I'd like to turn the call over to Angela Walsh Senior Vice President of Finance and Treasurer.
The real Therapeutics. Please proceed Angela.
[music]. Thank you good morning, everyone and thank you for joining us on today's conference call. We are pleased to be with you today to discuss various therapeutics second quarter financial results and corporate update. Please note that our financial results press release is now available on our website.
Before we begin I'd like to remind everyone that statements made during this conference call will include forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
Which involve risks and uncertainties that can cause actually results to differ materially from the information expressed or implied by these forward looking statements.
For more information regarding such risks and uncertainties. Please see the risk factors outlined in the company's filings with the SEC.
Any forward looking statements are made only as of today and we disclaim any obligation to update these forward looking statements other than as required by law. Please.
Please see the forward looking statements section in our financial results release issued this morning for more information.
It is now my pleasure to turn the call over to our CEO Greg Becker.
Thank you Angela and good morning to all of you joining us on today's quarter, two 2023 earnings update.
We have three specific topics to cover on today's call first I will begin with an update on our submission to the food and drug administration or FDA as you know it to progress our lead development candidate IMC, one into phase III development as a possible treatment for the millions of patients who suffer from the consequences of fiber.
L J.
We're very pleased to have our chief Medical Officer, Dr. My General on the call today to review the recently announced very encouraging results. We received from our exploratory long Covid study sponsored by video Therapeutics and conducted by the Bateman hand Center in Salt Lake City, Utah.
And finally, Angela Walsh will provide you with a summary of our quarter two financials.
Following the review of these topics, we will open up the call to questions.
Let me start with an update on our M. C. One phase III submission to the FDA.
As announced just yesterday, the food and drug administration communicated that following their initial review of the various therapeutics chronic toxicology program.
The program studies appear adequate to support the safety of the I M. C. One dosage proposed by the company for chronic use to treat patients with fibromyalgia.
With this critical feedback in hand, our goal is to initiate or proposed pharmacokinetics and food effect study later this year Walker.
While concurrently submitting an updated phase III program outlined and all of the associated study protocols for final FDA radio.
This planned PK and food effect study in males and females will be executed as a precursor to the fibromyalgia studies with an updated IMC, one dose and formulation, which is intended to enable the company to take full advantage of all of the efficiencies afforded with the utilization of the fiber.
Five b two regulatory pathway.
The forthcoming phase III fiber miles a program proposal consists of three main study components.
The plan is to execute two adequate and well controlled studies one is a head to head study comparing AMC wanted to see bow and the second trial will be a full factorial design with each of the individual components of IMC one.
Cyclical and silicon.
A separate comparator arms.
And a long term extension study.
Just on data from the recently completed fortress phase two B trial.
We have proposed a phase III development program targeting community based.
Fibromyalgia patients who have not have not participated in prior fibromyalgia research trials.
Alternatively stated we plan to exclude or more formally screened out fibromyalgia patients who have participated in recent fibromyalgia research studies over the past several years.
Following completion of the aforementioned PK study the goal will be to begin enrollment in the first fibromyalgia phase III safety and efficacy study in mid 2024.
I would be happy to answer questions about the phase III plan during the question and answer session of today's call.
It is now my pleasure to turn the discussion over to our Chief Medical Officer, Dr. Jendro to share what we have learned from the recently completed long Covid study.
The data from this exploratory study underpins our belief that I M. C to a fixed dose combination of that will stick with you and celecoxib has potential to improve the symptoms or <unk> as they are more formally though associated with the diagnosis of lung COVID-19 take it away Mike.
Alright, Thank you, Greg and good morning.
Before we dig into the long Covid data in the Companys initial thoughts on our development plan, let me convey that the team and I look forward to initiating our PK study with an updated formulation of IMC one for fibromyalgia, while finalizing the protocols and procedures required for the phase III development program as a treatment for <unk>.
Hi, Roger we believe the safety and efficacy results from our previous fortress trial, along with the chronic toxicology program results have enabled us to define a firewall your clinical trial program and a formulation and dose are by M. C. One to enhance our chances for phase III success.
Now switching to long Covid I would like to highlight the study design and the encouraging open label long covered data we announced in July .
First I think it would be useful to provide some background on the illness itself. This.
This includes the criteria by which a patient is diagnosed with lung COVID-19 and the symptoms underpinning the significant morbidity associated with this illness.
Long Covid is also referred to as post acute sequela of COVID-19.
Or P. A S C pasque.
Tasks symptoms may include severe fatigue.
Exertional malaise brain fog, dizziness sleep disruption loss of smell or taste and orthostatic intolerance.
Prevalence estimates suggest as many as 65 million people worldwide suffer from P. A S. C. It's more common in females and in patients with preexisting conditions, such as asthma, chronic obstructive pulmonary disease hypertension and depression.
The World Health organization diagnostic criteria are based on a continuation of or development of new symptoms three months. After the acute COVID-19 infection has resolved and lasting at least another two months without another explanation.
We know that COVID-19 acute infections connectivity, an immune response in some cases severe COVID-19 infections can lead to an exhausted immune response in cases, where the immune system is now exhausted or ineffective. We believe the lack of routine immune surveillance functions can lead to.
Asian of latent herpes viruses that the patient was previously infected with.
Our hypothesis is that late viral reactivation leads to further dysregulation of the immune system persistent inflammation and what we refer to as the TASC symptoms or long COVID-19.
This hypothesis is consistent with what it's been suggested by the mechanistic task force working on the recovery initiative at the NIH recovery stands for researching COVID-19 to enhance recovery.
This hypothesis that reactivated herpes viruses are involved in at least some of the symptomatology associated with long Covid served as a Genesis for an open label single Center investigator initiated study conducted by the abatement Horn Center.
Under an unrestricted investigational grant provided by various.
Pigment Horton as a nonprofit interdisciplinary centre of excellence advancing the diagnosis and treatment of chronic fatigue disorders, including M. A C. S. S fibromyalgia post viral syndromes and related illnesses.
Now given that let me walk through some of the data showing the results from this David Horn study.
Slide two shows what's known as a concert diagram for the study that is the flow of patients through the study.
So.
They've been heart center recruited patients for the study they screened 46 potentially eligible long COVID-19 patients that were recruited either from their own internal cohort of patients that you're monitoring or they had advertised from other treatment centers in the Salt Lake City area.
Of those 46 were screened 39 were eligible for the study and enrolled into the clinical trial at.
22 of those patients were assigned to receive treatment with Val cycles here and Celecoxib. Those are known as the assignment as the treatment group and 17 were assigned to a matched control group that is the patients are matched for age gender and duration of disease, but did not receive the zelle Sally combination.
The treatment group 20 patients completed the 14 weeks of treatment one patient withdrew the study due to adverse events that were possibly related to treatment and one was terminated from the study by the investigator for noncompliance with the protocol all 17 control patients completed the study.
Slide three please.
The primary endpoint in this study was a reduction in fatigue over 14 weeks. The fatigue was measured with something known as the NIH promised fatigue.
Instrument. The promised fatigue is a guess where those developed by the NIH to be measure various aspects of fatigue in patients. It measures physical fatigue mental fatigue. It's a self report the patients complete these at clinic visits and provide feedback on overall, how they believe their fatigue is doing overtime.
And we look at the change from the starting point or their baseline value.
What we saw after 14 weeks of treatment was that the patients receiving the valve Sally combination had a statistically and clinically meaningful reduction in their fatigue of 7.2 points on the scale on the promised fatigue scale a change of three to four units is considered to be clinically meaningful so they had.
Better than seven point reduction in their fatigue level, whereas the control group, where the standard of care group had a pretty much a no real change in their fatigue level over the 14 weeks that was statistically significant endpoint 008.
And as I've said previously it's also clinically meaningful. So this is something patients really could experience in and realize they were getting some benefit from <unk>.
Next slide.
Another important.
I'll come measure we used in the study was this orthostatic intolerance.
Orthostatic intolerance.
He is a common finding in long COVID-19 patients and <unk> patients.
That is related to autonomic dysfunction a normal.
That when a patient goes from city to standing or lying down to standing is your body compensates fluids changes in blood pressure too.
Maintain blood flow to the brain and when we have autonomic dysfunction, sometimes those reflects as or not don't work quite right and you get symptoms as if you're going to St. Jude can get tunnel vision and you can get changes in blood pressure heart rate you get sweating you just don't feel right. These are related to these orthostat.
Dysfunction and so since we see this is a common side effect in patients with long covered we measure we used an instrument that measures orthostatic symptoms.
And it was two two domains. This measure there's a orthostatic symptoms domain, which really directly measure the symptoms and there's been activity limitation domain, which looks at what you can or can't do or what are impacted by these symptoms and on the scale that was applied to all the patients in this study we saw statistically significant.
Improvement in symptoms shown on the left graph on the left of over nine points on the Val <unk> combination and the control group actually gotten a little bit worse overtime. So that was highly statistically significant.
And the scale on the right is the orthostatic activity limitations that as things you can no longer do because you're worried about these symptoms or you feel like youre going to.
Fall down lose consciousness whatever.
And again, we had over seven point improvement on Bell Sally.
On this domain versus and again the control group got worse and that was statistically system as well so both of these.
Measures that are hallmarks of both Emmy CFS and long Covid patients were approved by the Val Silly combination, which was this was new to US we haven't seen this before and we found out was quite quite an important finding with this treatment.
Slide five please.
So here's a summary of all the outcome measures that showed some effect in this small clinical trial and this is comparing the Val silly combination to the control group at week 14, we've already shown that the NIH promised fatigue T score was improved so the.
The primary endpoint of fatigue was statistically improved even with these small numbers.
We also measured fatigue on <unk> to 10 scale, that's where zero was I have no fatigue anymore and 10 was its worst possible fatigue. They patients completed this at home every week through a survey.
And what we saw over 14 weeks as they also reported improvement on this scale as well as on the promise skill.
At the same time, they were doing the zero to 10 fatigue scale. They were doing a zero to 10 pain scale at home weekly and.
Well not as predominant effect as the fatigue. We also did see statistical improvement in their pain self rated pain on a weekly basis as well.
Ah patients completed two different patient global impression scales. This.
Patient global impression is.
Asking them, how they think they're doing overall since beginning the study that is general general overall health. We had two different scales. One was a 1% to seven scale, where seven says I'm doing really well in one means I'm doing really poorly and also a zero to 10 with the opposite direction intentionally where zero means I've got the best possible health in 10 minutes.
Is the worst it could be.
And on both of those skills completed at clinic visits patients reported statistically.
Better results on treatment than on the control group.
We've showed you the two orthostatic intolerance scales were statistically significant at endpoint and we also had something called the hospital anxiety and depression scale. In this study. So it has a domain for depression symptoms in a domain for anxiety symptoms.
Depression symptoms trended towards statistical significance, but certainly went in the right direction and the anxiety.
Let's see I'll actually was statistically significant at week 14, as well in the treatment group versus control. So that was all very encouraging that we have all the study end points going the right direction and statistically significant in most cases.
From a safety standpoint, I'd treatment with Dell till the combination was generally well tolerated and what we saw in terms of safety profile and any adverse events was really consistent with what we already know about zelle cycle here and Celecoxib. It doesn't look like there's any combination toxicity hit them and nausea was far and away the most common.
<unk> of that which is a known effect of Celecoxib in particular.
Most common adverse event in the routine care or the control group was headaches and muscle pain.
There were no serious adverse events in the study and we only had as I mentioned one.
Treated patient discontinued due to adverse events, which were possibly related to valves Sally treatment.
So with that summary, let me go to slide six and outline the next steps. So we have filed a provisional method of use patent for treating long COVID-19 with this combination of focusing on fatigue and orthostatic intolerance.
And if that should issue we would have very good patent coverage for quite a while.
We are proposing a follow on study with the Baby Horn Center too.
Essentially replicate these results using a double blinded placebo controlled design.
And we also are preparing a pre IND meeting request to meet with the FDA and ask for their guidance on in the development plan for our long Covid indication with a anticipated meeting with the FDA later this year.
Yeah.
So with that I.
I would like to say in summary that female patients who were diagnosed with lung COVID-19 and who were treated open label with a combination of zelle cycles here and Celecoxib for 14 weeks exhibited clinically and statistically significant improvements in fatigue pain general wellbeing and symptoms related to autonomic dysfunction as compared.
To a control cohort a female long COVID-19 patients matched by age gender length of illness, who were then treated with routine care.
The statistically significant improvements in lung COVID-19 symptoms and general health status were particularly encouraging given that the mean duration of long COVID-19 related symptoms with two years for both the treated and control cohort prior to enrollment in this study.
I would be happy to answer further questions about our data analysis and our development plans during the Q&A session.
Let me turn the program back to our SVP of finance and Treasurer.
As al Walsh discuss our Q2 2023 financials Angela.
Thank you Mike.
With respect to our income statement as a development stage Biotechnology company, we did not generate revenue during the three months ended June 30th 'twenty, 'twenty, three or a game in the year ago quarter.
We reported research and development expenses of $6 million for the second quarter ended June 32023, as compared to $18 $4 million, but a year ago quarter.
The decrease in research and development expenses from the year ago quarter was primarily due to a decrease in clinical trial expenses of $1.7 million related to our completed fortress study and a decrease in expenses related to our chronic toxicology program point $10 million.
It was offset by an increase in drug development and manufacturing costs.
$1 million.
We reported in general and administrative expenses of $9 million for the second quarter F. 2023 as compared to $1 $3 million for the year ago quarter.
The decrease from the year ago quarter was primarily due to decreases in expenses associated with being a public company off point $2 million legal and accounting fees, plus $1 million and salaries and related costs of $1 million.
Finally, we reported a net loss of $1 $4 million for the second quarter of 2023 as compared to a net loss of $3 $7 million for the year ago quarter.
The lower net loss was primarily due to lower research and development cost as well as operational costs that I just mentioned.
In July 2023, we entered into a capital on demand it sounds agreement with Jones trading.
This type of agreement often referred to as an aftermarket or ATM agreement provides a public company with the ability to raise capital as needed at the prevailing market stock price. It is a common practice for biotechnology companies to have this type of agreement in place since compared to alternative financing methods.
It typically provides a lower cost of capital legislation every time and flexibility as there is no specific requirement our obligation to raise any amount of funds.
As of June 32023, we had $4 $6 million in cash as compared to $7 million.
At December 31, 2022.
We expect that the company's cash balance at June 30th.
The additional amount raised under the ATM agreement with Jones trading to be sufficient just on operating expenses and capital requirements for at least the next 12 months.
I will now turn the discussion back to Gregg to wrap up and moderate the Q&A session Greg.
Thanks again Angela.
Operator, we are now ready for questions.
Thank you at this time, we will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.
Confirmation tone will indicate your line is in the question queue. You May press star two if he would like to remove yourself from the queue for.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again. Please press star one if you wish to ask a question on one moment, while we poll for questions.
And the first question today is coming from David boats from Zacks small cap research David Your line is live.
Hey, good morning, everybody.
Greg I was wondering if you could start I'm talking about the fibromyalgia market, a little bit and I think how it relates to the patient population that you're going to be targeting in the phase III trial, where you're gonna be limiting it to patients who havent been in prior fibromyalgia studies and do you.
You first see any effect on a potential label for the drug by limiting that patient population. If if you want us to be approved.
Hi, David Good morning, and thank you for the question I think it's a very good question.
The short answer is the number of patients who've been involved in prior clinical studies is actually a very small fraction of the total universe, probably low single digits.
So I don't think this materially impacts our commercial opportunity if for some reason we were labeled as hasn't been studied in patients with prior.
Prior research experience so to speak we believe the Overrepresentation of these patients in our previous fortress phase two B trial was largely a function of the COVID-19 quarantine environment.
And under normal conditions, we should be able to recruit the study using both classic advertising social media outreach without undue delay. So I think there's going to be very minimal impact on the overall commercial opportunity.
I would also say as you probably heard through the course of todays discussion we will be advancing the pharmacokinetics study in both males and females.
With the potential presuming FDA buy off.
That we can actually studied both genders moving forward. So in fact, I think there's probably a net positive relative to the broad label.
Potentially if.
If we progress with both males and females in the in the phase III.
That answer your question David Yes, Thank you and speaking of the Teekay and food effect study I'm just a couple quick questions about that I'm sure. What what outcomes are you looking for there do you foresee any type of food effect on I N C. One and.
And then did I hear correct or is this a do formulation that you're going to be studying in this and in that study also.
Yes, so that's the two.
Two questions. There. So let me start with the second question first so the revised I M. C. One formulation is again a single combination tablet.
We are.
Progressing with this new tablet in phase III, because that is the tablet that will conform to a commercial requirements.
We are removing some excipient from their research.
Formulation small stuff, but small request from FDA, so that new formulation is ready for both phase III.
As well as for.
Commercial launch presenting success in the phase III.
The reason, we're progressing this new formulation with a new dose, which is closer to the phase Iia dose.
It is because we want to take advantage of all of the efficiencies under the 505 B two regulatory pathway as I mentioned in my earlier remarks.
It's a whole host of other ancillary phase III programs that nobody cares about but are costly and increased time et cetera. So.
As you probably know the treatment effect size in the phase two b.
In the phase two way was largely similar between the two doses the face to be dose was about three times larger than the phase Iia dose and.
And effectively what we're going to do is progressed with a dose that's in line with those reference doses of FEMSA quicker and Celecoxib does very close to the phase Iia dose to be most efficient as we progress into the phase III. So two reasons for it one the efficiency to to make sure we're locked and loaded on a formulation that is ready for commercial scale up presuming success.
The phase III.
Okay that makes sense and then yeah. It was just how long is that study going to take what what are the outcomes for the food effect study that those type of things, yes, I was going to go out so that I just want to make sure I answered your first one.
So the two things we're studying in this pharmacokinetics study using the new formulation.
Both total exposure as measured by classic area under the terms how much exposure is there from the new dosage compared to the reference doses as well as what is the Cmos or the maximum blood concentration, which usually occur shortly after administration of the drug so what we want to make sure that the C. Max maximum exposure and.
The total exposure, although dosing period at steady state are consistent with the dosage levels for the independent components, let's say I'm sick leave here and Celecoxib and by doing so we can utilize all of the safety longer term studies that were used to originally approved both famciclovir and celecoxib and evolve.
Doing all those other ancillary studies. So we can have a very efficient phase III with just two adequate and well controlled trials and patients from those trials can be rolled into a long term extension that gives us the most efficient way to progress. This phase III, which is good news for other superior shareholders and ideally patients moving forward.
Okay, and lastly, about long Covid I'm I'm curious if you'd talk about why you decided to do another a single center study with the abatement Heart center as opposed to the kind of expanding out and doing a larger double blind placebo controlled study at this time.
Very good question, David So the shorter answer is we're doing both I think you'd agree I mean, you look you need to look no further than you know today's headlines COVID-19 is here to stay.
And so we are commencing the double blind placebo controlled IMC to program and long Covid, which is fully funded it doesn't require us to raise additional capital. This is a very efficient progression.
So we can now study IMC, one under classic double blind placebo controlled conditions.
Simultaneously and I say this.
With great hopes moving forward, we are engaging with an NIH, who you are very familiar with but also the N. H L. B I, which is working with NIH E N H L. B I as the National Heart lung and Blood Institute for those that are not familiar.
As to academic institutions are actually evaluating and administering the funds at any age really recently allocated to research and more on Covid.
And they are evaluating different options moving forward, we've engaged with them we.
We have some.
Meeting set up this fall to talk with them about the study that Mike provided the topline highlights with all of which is to say, we're looking to see if we can't.
Secure some non dilutive funding options for the broader phase two dose ranging study that is the next step in the more classic development process. So it's really two shots on goal here.
We will provide updates on the progress on both as we get into fall and are closing in on the end of the year.
But suffice it to say hopefully you can get a sense David.
But if you were excited about fibromyalgia, which we all are obviously anybody on the call is we now have a second program is a complement to the fibromyalgia program and we're leaving no stone unturned, we'd like to progress the confirmatory trial and see if we can secure either partnership or non dilutive funding to progress the more classic.
<unk> phase two be a dose ranging study so really two shots on goal with that.
And as Mike mentioned earlier, what were really excited about here for IMC to us having filed a provisional patent if that patent is granted that will extend our intellectual property protection out to roughly 2044. So long lead time on the method of use patent to be able to research and progress the lung cohort program as a complement to fibromyalgia.
Okay and so various is sponsoring this study at the Baby Hoard center is that correct.
Manhattan incentive program is funded so we do not need to raise any.
Any additional capital to run that program, we will look towards partnership and potentially non dilutive funding through N. H L. B I and then I H under the recover umbrella to potentially fund that mixed confirmatory dose ranging study because we'd like to look at multiple doses in that and that are secondary to trial that.
Would require a partnership or non dilutive funding, but as you probably have seen under our recent headlines both scientific and lay press.
There was a lot of information about characterizing long Tobey and I think NIH and N H L. B I don't know repurposing their focus to focus more on treatment. So I think everybody realizes long ago, but here. It is here to stay and as a consequence.
Long Covid as you're as a result of this continuing Yale new pathogens.
New I think it's five variation now that well something of that Oh. This is gonna be like the flu and I think long cobalt will follow is new versions of Covid. So this could be very timely and very very helpful for patients.
Okay, great. Thanks for taking the questions. This morning of course of course, Thank you David.
Thank you. The next question is coming from Sean Lee from H C. Wainwright, Sean your line of life.
Good morning, Greg and thanks for taking my question.
Two quick ones firstly on the <unk>.
Upcoming.
New long cobalt study, so oh other that'd be double blinded randomized study how is it is there any differences between the proposed study and what has been completed so far the abatement north.
So excellent question, Sean Thank you for joining and for your question.
As Mike outlined the original exploratory trial was open label.
In its approach and I think you'd probably agree executing at the same center or same condition same outcomes under double blind conditions is a higher hurdle rate and so we are looking to validate that particular, finding and will commence that program. This.
This fall and that is fully funded so what we'd like to do is actually validate that study under more classic double blind placebo controlled conditions are at.
At the same time as we referenced we do think a more classic phase two b.
And who knows what are the conversations with FDA goes that we we need to talk to them about what outcomes. They think are important here.
How they would like us to explore different doses for a long COVID-19 one of the other questions, which we didn't mention but I think it's important to reference in the context of your question. Sean is we will also ask the F D a about broader fatigue opportunities.
If you look historically at these combinations be it the phase Iia fibromyalgia trial, the phase two b fibromyalgia trial and now this exploratory long cobalt trial.
The impact on fatigue is robust.
Statistically significant and consistent across all of those three studies and so we do think it's early days, but our initial thought processes given the robustness consistency in concordance of the signal across all three studies would it make sense to potentially explore this particular combination and a broader suite of fatigue related.
Disorders, whether that's myalgic encephalitis or chronic fatigue syndrome, it's more classically known or some other form of fatigue also represents an opportunity. So that pre IMD meeting will certainly be mostly focused on non COVID-19, but we do think there is a potential to expand that research given the consistency of the signal to potentially other fatigue related.
Disorders.
Does that answer your question.
Yes.
Part of it with the other parties for the randomized study, that's helping in terms of endpoints and patient enrollment.
Collection I mean.
<unk> side are there any differences compared to the previously completed study.
The sample sizes in the forward double blind on Covid program will be a little bit larger.
That is specifically our goal I think we will also ensure patients have a diagnosis of COVID-19 that precedes a long COVID-19 that is consistent with other programs that FDA has endorsed blessed to moving forward. If you. If you look at some of the other a long COVID-19 related research history. They Wanna confirmed.
Diagnosis.
But suffice it to say we will be using the same dose. The same center will have a broader catchment area to.
To recruit this program, but this program will actually be a little bit larger, but will benefit from more bells, and whistles relative to ever advertising, social media outreach et cetera to potentially accelerate recruitment in that particular trial.
Oh I see great.
It sounds very exciting and definitely looking forward to the results of this next one.
Uh huh.
Second question is on the.
Proposed fibromyalgia study I may have missed it in the prepared remarks, but the PK study that will start later this year, what's the size and the expected duration.
So the actual study itself only takes two to three weeks to run.
At a phase one center.
The.
Size will be probably 20 ish.
Patients per arm 15 to 20 patients per arm and effectively what you're studying is the levels of the combination product versus the independent components and so it's a relatively efficient study to run our goal is to actually commence that study this year.
To be ready to begin outreach on the more formal phase III program, but head to head studies. The one we're going to start with the phase III program as we turn into 2024.
Great.
Great. That's all I need to know thanks again for taking my questions.
Of course, thank you very much again, showing for just embryos and for participating on today's call.
It looks like thank you.
Well, we don't have I'll turn the call back.
Yep.
Over to you Mr. Duncan for final remarks. Thank.
Thank you Sir.
Summary of the team and I are really very encouraged about the potential to expand our pipeline and progress I am. So you wanted to phase III development as a treatment for fibromyalgia and now IMC two into phase two development as a possible treatment for long COVID-19.
In short we're now complementing the fibromyalgia program with a very robust long cobot program, which has very significant commercial potential on its own merits.
This year more specifically our goal is to initiate the IMC, one pharmacokinetic and food effect study as I've just referenced in the Q&A.
Later this year using the dose and formulation, we plan to progress into both phase III and into commercial scale up presuming success in phase III and at the same time, we'll be submitting the final outline and the study protocols for final F. D. A blessing, we have time to do that without delaying the start to the phase III program as we run the PK study.
As Mike shared we are extraordinarily encouraged by the clinically and statistically significant improvements in fatigue.
And symptoms of autonomic dysfunction.
That were observed in a long Cobra study as you can see in the popular press Covid is not going away. It is here to stay and if you think about orthostatic hypotension and the population that is most at risk for both covered and non Covid fall could lead to hip fracture in a whole series of very significant health consequences. So getting it right for these.
Patients with long cobalt controlling their fatigue controlling their autonomic dysfunction could be a very very significant upgrade in the standard of care and health for these particular patients.
We anticipate meeting with the FDA in the second half of this year to discuss opening a new investigational drug by drug application as Mike referenced the more formally necessitate himself symptoms for patients with long COVID-19 and potentially your broader fatigue syndrome, using our second development candidate I M. C. Two which as you are probably well aware, but for completeness is a fixed dose.
Combination of valve sickle, there and celecoxib.
As Mike also mentioned, we plan to execute the confirmatory study nears IMC to as a treatment for long cobot under double blind placebo controlled conditions. This study is fully funded we plan to commence this study starting early fall.
We will work closely with the FDA as you would well imagine to determine our next steps in advancing both of these very promising programs and look forward to providing consistent updates over the course of the second half of this year.
Want to thank you all for your interest in videos and for attending today's earnings update.
Pleased to tell you that our pipeline now has very few significant opportunities and we are committed to advancing those opportunities as expeditiously as possible with the goal of getting both IMT, one and IMTT into the market to help millions of patients who suffer from fibromyalgia <unk> Vancouver sequela.
Thank you for attending today's call.
Thank you. This does conclude today's conference you may disconnect. Your lines at this time and have a wonderful day and thank you for your participation.