Virios Therapeutics, Inc. (NASDAQ:VIRI) Q3 2022 Earnings Conference Call November 14, 2022 8:30 AM ET
Company Participants
Greg Duncan – CEO
Ralph Grosswald – SVP, Operations
Angela Walsh – SVP, Finance & Treasurer
Dr. Mike Gendreau – Chief Medical Officer
Conference Call Participants
Sean Lee – H.C. Wainwright & Co., LLC
Operator
Good day, and welcome to the Virios Therapeutics, Inc. Q3 Earnings Update. [Operator Instructions]
It is now my pleasure to turn the proceedings over to Angela Walsh, SVP, Finance and Treasurer for Virios Therapeutics Inc. Angela the floor is yours.
Angela Walsh
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 Virios Therapeutics third quarter financial results, as well as provide a summary on of our ongoing analysis of the results from our recently completed Phase 2b fibromyalgia trial also know as the FORTRESS study. Please note that our financial results press release is now available on our website.
We’ll start today’s call with our CEO Greg Duncan, providing you with a brief update on our corporate progress during the past quarter. Then he will turn the call over to our Chief Medical Officer, Dr. Mike Gendreau, who will provide an update on our FORTRESS study analysis, and then I will return to review our third quarter financial results. In addition, Ralph Grosswald, our Senior Vice President of Operations is with us for the question and answer portion of the call.
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 involves risks and uncertainties that can cause actual 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 see the forward looking statements section in our financial results press release issued this morning for more information.
It is now my pleasure to turn the call over to our CEO Greg Duncan.
Greg Duncan
Thank you, Angela. And good morning to all of you joining us on today’s quarter three earnings update. Our goals for today’s discussion are threefold. First, following our announcement of the top line results in mid September, we will provide you with a summary of what we have learned so far from our detailed examination, the FORTRESS phase 2b Fibromyalgia study data. Second, we will outline our proposed plan and projected IMC-1 development milestones this year and into 2023. And finally, we’ll provide a summary of our quarter three financials before opening up the call to receive participants questions.
On September 19 we reported that the FORTRESS study demonstrated that IMC-1 was safe and very well tolerated, but did not achieve statistical significance on the pre-specified primary endpoint of pain reduction. The results were confounded, particularly when viewed in the context of both mechanistic data highlighting the role of active replicating herpes infection in patients diagnosed with fibromyalgia, as well as the results of our previously successful phase 2a Fibromyalgia trial. Recall this prior phase 2a trials clearly demonstrated, IMC-1’s potential as a novel approach to treat the pain, fatigue and other symptoms associated with a Fibromyalgia diagnosis.
In mid September, we discussed that our preliminary top line analysis of the data suggested an unusual bifurcation of response based on the timing of patient enrollment in the FORTRESS trial, by way of background enrollment of the first 50% of patients placed from June 2021 to early November 2021. For context, this was when the Delta variant of COVID-19 was the dominant strain here in the U.S. full vaccination rates were far below the levels we enjoyed today and probably most importantly, extensive quarantining was still in place in most geographies. The patients enrolled and treated with IMC-1 in the first half of the study did not demonstrate a statistically significant reduction in pain when compared with patients treated with placebo during the same time period.
Conversely, during the second half of trial, which took place from November 2021 to April of this year, we enrolled the second 50% of patients into the FORTRESS study. This was a time period when vaccination rates had substantially improved. The less severe Omicron variant of COVID-19 became the dominant U.S. strain and quarantining restrictions were lessening or fully removed across many geographies here in the U.S. essentially, where we’re getting back to a more normal day to day lifestyle.
In stark contrast to the first half study in all this, the IMC-1 treated patients enrolled during the second half of the trial, which totaled 214 patients demonstrated a statistically significant improvement on the primary pain reduction endpoint at week 14 as well as statistically significant improvements in fatigue and fibromyalgia symptoms. The Virios management team believed that the likelihood of such a substantial differential response based on the timing of patient enrollment was highly unlikely to be a random occurrence.
Alternatively stated, we as a team believed the positive outcomes demonstrated in the patients recruited during the second half of the FORTRESS study, a sample of patients that is roughly one half the size we believe was required to demonstrate statistically significant pain reduction over the full trial required deeper exploration.
Virios management team has spent the past few weeks deeply analyzing the FORTRESS data to better understand the factors driving the top line results. This understanding will help the team design an IMC-1 development program that targets the patients who are most likely to respond to IMC-1 treatment.
The team has identified several factors that had both positive and negative impacts on our final study results. We have vetted these findings with multiple highly recognized Fibromyalgia research thought leaders, who corroborated our view that the FORTRESS study results are unlikely due to chance, and that the positive results we observed in the FORTRESS trial do support the potential of IMC-1.
These experts supported our proposed plan to continue the development of IMC-1 as a treatment for patients diagnosed with fibromyalgia. We will shortly be requesting a live meeting with FDA with the goal of progressing IMC-1 development to phase three next year.
It is now my distinct pleasure to turn the discussion over to our Chief Medical Officer, Dr. R. Mike Gendreau to share what we have learned that underpins our continued belief that IMC-1 can improve the treatment of fibromyalgia. Mike will also share our thoughts on the broad parameters of the plan we will propose to FDA to advance the development of IMC-1 moving forward. Take it away, Mike.
Dr. Mike Gendreau
Thank you, Greg. And good morning. As Greg referenced, the Virios research team has spent the past several weeks analyzing the FORTRESS data in detail to better understand the factors and patient demographics that led to responses that were not consistent with our prior research, or with the design goals of the study, particularly with respect to the rate of placebo improvement in the trial. However, as Greg mentioned, responses of patients enrolled in the second half of the trial from November to April 2022 were consistent with the expected efficacy profile IMC-1 and at all time points, the safety and tolerability of IMC-1 was outstanding. In the original post hoc first half second half analysis that Greg mentioned, the subgroup of patients recruited from November to April demonstrated statistically and clinically significant improvements with half the original plan sample size. Our efforts over the last few weeks have been directed at achieving a better understanding the factors that led to this different response over time, as well as identifying populations and characteristics that were more responsive overall to IMC-1 treatment.
I am now pleased to share with you a summary of what the research team has learned to-date. As you might imagine, a full understanding of the factors impacting the FORTRESS results had to be conducted in a careful manner considering the impact of enrollment timing that we shared back in September, many demographic variables and subpopulations were analyzed to understand why the FORTRESS results differed from our original design goal. So far we have learned the following.
First observation is that post hoc analysis of the FORTRESS trial results indicate that FM patients who were new or naive to clinical research studies, which we will call new patients, demonstrated clinically and statistically significant reductions in pain, fatigue, fibromyalgia symptoms, anxiety and depression symptoms. Improvements in this population were statistically significant for the entire study timeframe. So results in this population were far less impacted by the enrollment timing as compared to other subpopulations.
In contrast, enrolled patients who are prior-Fibromyalgia trial participants and our study site database patients, who we will call experienced patients now appear to represent a more treatment refractory or treatment resistant cohort of patients, and they did not exhibit a meaningful treatment benefit in this study in either timeframe.
Historically, we’ve used a combination of dedicated research sites, as well as sites that both recruit patients for clinical trials and provide general medical care for patients in their communities. Our data indicates that the dedicated clinical research sites that were less likely to experience staff turnover in the pandemic delivered more consistent results including better placebo response management as compared to the clinical practice sites. Our plan moving forward will be to execute future IMC-1 trials with a focus on dedicated research sites.
While we were pleased to be able to successfully recruit the FORTRESS study in the midst of the extraordinary circumstances associated with the pandemic, it remains clear that this environment had unintended impacts on our overall FORTRESS trial results. While we can’t guarantee that future research will be conducted in a COVID free environment, we’re confident in IMC-1’s potential when targeting new patients who we believe represent our optimal patient target moving forward, given that they demonstrated lower placebo response rates, and the expected drug response rates irrespective of which half of the study they were recruited in. On a related note, we may now be reaching a saturation point in the United States Fibromyalgia research patient community, whereby experienced trial subjects in those presently being treated for fibromyalgia may be characterized as becoming more refractory to treatment. This trend has been observed in several other research categories, such as depression, where more time and energy must be expended to recruit newer, more treatment naive patients for trials.
We expect this to be our plan moving forward with IMC-1 development. It is important to remember that as with the case, in our successful phase 2a study IMC-1 was very well tolerated by all study subjects, as evidenced by a discontinuation rate due to adverse events that was lower than placebo. This is a feature of IMC-1 that we believe supports progression to phase three development and if successful, could be a highly differentiated feature of IMC-1 treatment versus other available therapies.
In summary, while there are factors impacting our trial that we will likely never fully understand, such as the impact of COVID dynamics on a result over time, there are many factors we can conclude had a material impact on the FORTRESS results.
Importantly, we believe with this understanding, we can design future trials that will help us better manage many of these factors. We will shortly be requesting a guidance meeting with FDA to review our results and present our plans for advancing IMC-1 into full phase three development.
Given the observed excellent safety profile obtained in FORTRESS, we plan to propose a comprehensive phase three development program to FDA at that meeting. We understand that FDA is not granting any further live meetings this year. Hence, we are likely to receive our FDA feedback sometime in the first half of 2023.
I would be happy to answer any further questions about our data analysis and our plans moving forward during the Q&A session.
Let me welcome back our Senior Vice President of Finance and Treasurer Angela Walsh to discuss our quarter three financials. Angela?
Angela Walsh
Thank you, Mike. As discussed during our second quarter earnings update at that time, the company had cash to get through 2022. In this context, and based on the aforementioned bifurcation of response data, we made the decision to raise additional capital following the reporting of our FORTRESS top line results in September. This additional capital provides the company with approximately 12 months of new operational runway and as allow the engagement of external consultancy resources required to review the FORTRESS data in greater depth.
The capital also provides us time to discuss both the forecast data and our proposed forthcoming IMC-1 development plans with the FDA. We project those discussions will most likely occur in 2023. Albeit timing will be dependent upon the FTDs current workload, especially related to requests for live meetings, which we plan to do.
As of September 30, 2022, we had $9.8 million in cash as compared to $14 million as of December 31, 2021. We expect our current cash to be sufficient to fund the company’s operations through the end of 2023 but note that any future IMC-1 development including phase three studies will require additional capital. With respect to our income statement as a development stage biotechnology company, we did not generate revenue during the three months ended September 30, 2022 or during the three months ended September 30, 2021.
We reported research and development expenses of $1.6 million for the third quarter ended September 30, 2022 as compared to $3.8 million for the year ago quarter. A decrease in research and development expenses quarter-over-quarter was primarily due to a decrease in clinical trial expenses for our FORTRESS study of $0.9 million, a decrease in expenses related to our chronic Toxicology Program of $0.4 million and a decrease in drug development and manufacturing costs of $0.1 million.
We reported general and administrative expenses of $0.9 million for the third quarter of 2022 as compared to $1.1 million for the year ago quarter. A decrease quarter-over-quarter was primarily related to a decrease in salaries and related costs.
And finally, we reported a net loss of $2.6 million for the third quarter of 2022 as compared to a net loss of $4.1 million for the year ago quarter. A lower net loss was primarily due to the lower research and development costs I just mentioned. Let me turn the discussion back to Greg Duncan to wrap up and moderate the question and answer portion of the call. Greg?
Greg Duncan
Thanks once again, Angela. The extensive data analysis of the FORTRESS study conducted by Mike and our research team has been covered several key insights into which patients are most likely to respond to IMC-1 irrespective of external factors including COVID related dynamics. This includes recruiting patients new to fibromyalgia research, with additional emphasis on screening out fibromyalgia patients with a recent history of treatment failure, or patients who have previously participated in fibromyalgia clinical trials.
This proposed approach is supported by data gleaned from the analysis of the FORTRESS study. We believe these insights will enable us to design a phase three program to be discussed with FDA over the coming months. We hope to reach alignment with FDA in the first half of 2023, subject to FDA availability for live engagement, and to commence the next phase of our IMC-1 research program in the second half of 2023.
As Angela referenced in her remarks, we have capital to support operations until the end of 2023. But future research will require additional capital and/or partnership support. In addition to engaging with the FDA, we will also commence discussions with both current and new investors and prospective partners to determine the optimal path forward for funding and executing IMC-1 development.
Our ultimate goal remains the same. Getting IAMC-1 to market to enhance the standard of care for hundreds of millions of fibromyalgia patients not presently satisfied with current treatment options.
Operator, we are now ready for questions.
Question-and-Answer Session
Operator
Thank you ladies and gentleman. The floor is now open for questions. [Operator Instructions] Our first question is coming from Sean Lee with H.C. Wainwright. Sir please go ahead.
Sean Lee
Good morning, guys. And thanks for taking my questions. I would like to get some of the understand better the rationale behind the analysis. And could you explain what based on the mechanism of action good drugs why is it that some of the new patients would have a better response rate than the experienced fibromyalgia patients?
Greg Duncan
Hey, Sean, this is Greg Duncan, let me take that one. So as you know, the whole ethos of the program is a fundamentally new approach to treating patients with fibromyalgia by trying to get to a potential root cause and that is in fact why we recruited both treatment naive patients into the program as well as those that had been participating in other trials because of the novelty of this mechanism.
And as Mike mentioned in his earlier comments, we may be hitting a point where that second group, those experienced trial participants, may represent a more refractory patient population. We may be hitting that tipping point and that was actually validated by the three key opinion leaders we spoke to, as we reviewed the data that we’re discussing today.
We don’t have a clear reason as to why some patients may not have responded in that refractory group. It may represent just a more refractory treatment population, which is what we’ve seen in depression or other areas. There is a potential that the act of replicating virus was not as consistent in that group, as we saw in the new and naive patients. But that’s just a guess.
We really don’t have a clear view as to why that would have happened, other than the fact that most of those prior trial participants or represent a group of patients that in the majority had been previously treated and/or experienced other new therapies, and not responded, which is why they were candidates for our trial. So I suspect it’s just a general overall refractory nature of the patients.
Sean Lee
I see. Thanks for that. In terms of the classification of patients do you whether these new or experienced classification has been using any other clinical studying fibromyalgia, or whether that’s a standard classification for patients in this setting?
Greg Duncan
So the way we define the new patients were patients who were recruited through advertising. These were patients that had not identified as prior clinical participants, clinical trial participants nor were they patients that were on physicians lists. And why I referenced that second group is because while a patient may not have recently participated in the trial, by definition, particularly in the purely research centers that we used, those patients will likely were in a trial sometime in the in the distant past. And so the goal going forward will be to make sure that we do not use that kind of tried and true recruiting mechanism. The way you run these trials is you go out and you say, okay, let’s get all the patients off your list, that you’ve been in prior clinical trials, you exhaust that patient pool, then you move to the newer patient sites, newer patients, excuse me, who we know in this particular analysis, were not prior clinical trial participants.
They may have been previously treated. But they were not previously in clinical trials. Those patients are a little bit harder to find, but it is relatively manageable. We did this in depression back in the day. You can use differential screening requirements here in the U.S. so that you recruit only those new patients. We can also consider going to other geographies, which we think actually makes sense anyway, as we consider moving to phase three, because that’s really starting to saturate other markets, get them some experience with IMC-1 through clinical research as a precursor to launch. So we do think it’s manageable through better screening and we think it’s the wise way to go here based exactly on the data we just share with you today.
Sean Lee
I see. My last question is on potential phase three study. So in terms of size, and then you mentioned around the geographies. What can we expect what like what would you be proposing to the FDA?
Greg Duncan
So we’re in the process of finalizing that recommendation, but our general approach will include the following. Again, subject to FDA feedback will likely do one multifactorial trial, which is an FDA regulation. So that’s IMC-1 placebo, and probably will include two arms, one celecoxib one famciclovir as independent components. We can certainly argue there’s probably no reason to test famciclovir. But FDA may have a different view on that. So think of that as probably a three or four arm study. We will make the case that we should do one head to head again a second head to head of IMC-1 and placebo. That may, that may be a two arm trial, FDA may come back and say we would like you to do two multifactorial trials.
And then the third key component of the program that we will be proposing would be an open label extension to clean the safety data that are required as part of the overall package to support an eventual NDA if we continue to be successful. So it’s probably three studies. Hopefully one multifactorial and one head to head with the caveat that it may be two multifactorial depending on FDA feedback, and an open label extension. So three particular trials and then there will probably be some other kind of classic trials of food effects, etc that are standard part of the phase three.
Sean Lee
Thanks for the additional color. That’s all the questions I have. And thanks again for taking my questions.
Greg Duncan
Thank you for participating Sean. Appreciate the questions.
Operator
[Operator Instructions] Our next question is coming from David Bautz with Zacks. Please go ahead.
Unidentified Analyst
Actually, excuse me, it’s Richard [indiscernible] calling for David. Hi, Greg. Hey, Angela, how are you?
Greg Duncan
Hi, Richard. Good morning.
Unidentified Analyst
Good morning. Yes, David, I’m sure he’s going to follow up shortly. He just couldn’t be on the call this morning. So he gave me a few questions to ask you guys. I think you’ve been very clear about what happened with IMC-1 and the FORTRESS trial and things like that. So I’m sure he’ll want to dive in and dig a little bit deeper, but I think it’s encouraging, you’re going to take it into phase three with the new FM patients. So that’s great. Maybe, and I’m sure you’ve given a timeline, I’m sure you can’t give it any more than that. So as I understand it, it’s going to be shortly getting with the FDA, hopefully, a live meeting the first half of next year, and then hopefully approval first half of next year, and then moving into phase three, second half of next year, if I understood you correctly, and then in the interim, there’s going to be additional funding required. So my question is simply, what are the factors that would accelerate that whole process? What are the factors that would delay it? And can you give a range on the kind of funding required?
Greg Duncan
Okay, thank you, Richard. There’s a lot in there. So let me try to address that. Number one, our goal would be to go to phase three, that’s obviously subject to FDA feedback. So I think it’s important to mention that that is our goal. We can’t guarantee that but we think that totality the data, the safety data, the efficacy data in this population, support progressing to phase three.
The timeline we gave you is our best guess at this point. It is our understanding, based on our interaction with our regulatory consultants, that FDA live meetings requests are not being scheduled for the balance of this year. They are now targeting last intelligence sometime in the middle of quarter one to the end of quarter one. So that is our best guess at this point. The goal would be to have that live meeting, the FDA then has 30 days for formal feedback. And our goal would be to clean that feedback and obviously report that out to the external community here as an entity.
The best guess we can give you right now is if we’re successful in those discussions, which we hope to be, that we could commence recruitment in that program sometime in the second half of 2023.
Probably, needless to say, but for completeness, we have good relationships with the research sites. We will continue to nurture those relationships so that we are ready to go subject to funding, financing, etc, and an FDA feedback. So that’s one of the benefits of the team having some such experience in the space is that we have very good relationships, Mike, Ralph, etc, with the sites to start as soon as possible.
The best guess on capital required at this point would be a general guess. You’re probably talking in the range of $65 million to $70 million for the phase three program in totality plus operations. If we are successful in finding a partner, that may be a lesser amount, but at this point, I think it’s probably a little bit early to get too refined and an estimate as to what phase three would cost because it’s subject to FDA feedback.
Unidentified Analyst
Got it. Okay. Thank you for that. Just a couple more questions. I want to switch over to IMC-1. David wanted to switch over to IMC-2, we haven’t talked about that. Have you ever considered testing IMC-2 in FM? Is that something that’s ever been considered?
Greg Duncan
So, we think the data really do support IMC-1 progression to phase three. IMC-2 as you may know so let me back up just for completeness IMC-1 is a combination of famciclovir and celecoxib. IMC-2 is valacyclovir and celecoxib. We selected IMC-2 the combination of valacyclovir and celecoxib for the long COVID trial. For one reason, one reason only it’s a little bit more selective based on our perusal of the data on epstein barr, which we think is the bad actor, the activation of secondary herpes viruses, including epstein barr, which is the bad actor leading to the fatigue, brain fog, etc. That’s associated with bone COVID sequelae.
And that’s the test. That’s the valacyclovir plus celecoxib in that trial, which we hope to finish recruitment by the end of this year and report out results sometime in the first half of next year. That’s the program that’s supported through a investigational grant to the Bateman Horne Center who is conducting the trial. So we can’t guarantee the timelines but we do talk to them frequently and think that is the rough timeline here for the long COVID program.
Famciclovir has very good activity against the number of herpes viruses. We have great formulation we know how to manufacture it relatively efficiently. And so the goal would be to move IMC-1 forward for fibromyalgia and we’ll explore what to do with with IMC-2 pending the results of the long COVID program.
Unidentified Analyst
Okay, and just so I’m clear David had mentioned is an IBS program that was put on the backburner. Is that something else? Is that what you were referring to because you’re focused on winning COVID with IMC-2?
Greg Duncan
So, we do believe this mechanism has utility across a number of different potential somatic syndrome disorders. The founder, Dr. William Pridgen was actually at gastric surgeon. He treats patients perform surgery, but also treats patients for things like functional GI disorders like IBS, and his original utilization of this combination was in an IBS population. So fantastic results, open label that saw really good results. He connected with a virologist at the University of Alabama.
And they actually executed a very novel program, where they biopsied the gut tissue of patients who had a diagnosis of fibromyalgia, patients who had a diagnosis of functional GI disorders, and compared them to control patients. These are patients that were there for follow up, maybe for a prior GI bleed, or some other form of follow up care, who were what I would describe as a control patient, if you will, and he demonstrated with Dr. Carol Duffy very clearly that patients with fibromyalgia has active replicating herpes infection in their gut tissue.
And so we believe that corroborates the activity of activated herpes virus in fibromyalgia patients. What was also presented as part of those data is there was a third portion of the study which were patients who had purely functional GI disorders.
So no fibromyalgia, just functional GI disorders, including IBS is probably the dominant category there. And he also noted active replicating infection in those patients in their gut tissue at a highly statistically significant level. The trial was so important that it was actually presented by Dr. Duffy at the digestive disease week meeting last year, sorry this year, I believe. And those data were elite breaker analysis. The poster presentation was elite breaker.
So there are certainly interested in the community in the connection between herpes virus activation and IBS. That is a program that we think we can execute as a complement to fibromyalgia. But the fibromyalgia program is priority one, long COVID right now is priority two, and presuming success over time, we do think there’s a potential to expand the research pipeline into IBS as a third potential priority. That’s obviously subject for the funding, community support, FDA feedback, etc.
The good news is, if we did an IBS program, we now have extensive safety data on IMC-1. As you know, Mike mentioned earlier, the tolerability and safety of IMC-1 is very good. And so that safety data would be an important part of the dialogue with the FDA moving forward if we decided to pursue that particular line of research with those safety data in hand. So that is our third priority right now. But we do think it is an exciting priority based on Dr. Pridgen’s experience in the GI biopsy study.
Unidentified Analyst
Excellent. Excellent. Well, thank you for that, Greg. And, as I mentioned, I’m sure David will be in contact shortly to follow up and things like that. So anyway, good luck. It’s encouraging you guys to move into phase three with new patients with new ones. So that’s great. We’re looking forward to 2023 and thank you for your time.
Greg Duncan
Yes, thank you, Richard. Our goal is certainly to take IMC-1 to phase three. We do believe in summary that the fortress data reveal that fibromyalgia patients that are new to research are an excellent target for progression of IMC-1 development ideally to phase three, based on the demonstration of significant IMC-1 benefits including reduction in pain reduction and fatigue, improvement in overall fibromyalgia patients symptoms and an improvement in overall patient’s global health.
We may be reaching that saturation point where those patients that were in prior clinical trials are representing a much more refractory population. So it will take a little bit more time and attention but it is certainly actionable and doable to target those patients moving forward for IMC-1 continued development.
We do believe very clearly that the safety data continued to impress. This is the second consecutive trial where IMC-1 had a lower dropout rate due to adverse events as compared with placebo. And as you probably recall, if you’ve heard the story before that the primary reason for dissatisfaction in the fibromyalgia patient community and amongst those doctors that treat those patients is the poor tolerability of the existing pre-approved medications.
They are all good medications. They reduce pain. But tolerability is the issue that leads to less than ideal compliance. As I mentioned during Richard’s question, we can see, FDA will endorse going to phase three, we really do believe the totality of the data specifically, the safety data support IMC-1’s progression to phase three.
And as I mentioned earlier, and Mike mentioned as well, we will shortly be requesting FDA feedback to advance that progression to phase three. And the long COVID program continues to recruit. We hope to conclude dosing by the end of this year with results in the first half of 2023.
Angela, Ralph, Mike myself, the whole team is committed to frequent and accurate communication moving forward as regards to operational progress. Full enrollment along COVID program will likely be our next key milestone. And then our goal, following the meeting with FDA is to immediately communicate to you all the external community what the next steps are for IMC-1’s development and fibromyalgia. And we’ll report back that at that time. Thank you for your time and attention on today’s call. And this concludes our quarter three earnings update. Thank you.
Operator
Thank you ladies and gentlemen. This does conclude today’s call. You may disconnect your lines at this time and have a wonderful day and we thank you for your participation.
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