Q2 2021 Virios Therapeutics LLC Earnings Call

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Ladies and gentlemen, thank you for your patience you are holding for today's serious therapeutics second quarter 'twenty 'twenty, one financial results conference call. At this time, we are gathering additional participants and will begin momentarily. We appreciate your patience and ask that you. Please continue to hold.

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Yeah.

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Good morning, and welcome to various therapeutics second quarter 'twenty 'twenty, one financial results conference call. 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 SVP Finance treasurer various therapeutics. Please proceed Angela.

Yes.

Thank you good morning, everyone and thank you for joining us on today's conference call.

We're pleased to be with you today to discuss various therapeutics second quarter financial results as well as to provide you with an update on the operational progress. We have made during the first six months of 'twenty 'twenty one.

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 and then I will return to review our second quarter financial results. In addition, our Chief Medical Officer, Dr. Mike Gen Row, and Ralph Boswell Our V P.

<unk> of operations are 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 involve risks and uncertainties that can cause.

Actual results to differ materially.

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 statement section in our financial results release issued this morning, and the risk factors in the company's current and subsequent filings with the SEC.

It is now my pleasure to turn the call over to our CEO, Greg Duncan Greg.

Thank you very much Angela and good morning, everyone.

We appreciate you joining us on the call today as we are very pleased to provide you with an update on our substantial progress the various therapeutics team has made.

Since our last quarterly update.

In May we dosed the first patient in our landmark phase <unk> fibromyalgia trial.

We refer to this trial is the fortress trial, which stands for fibromyalgia outcome research trial evaluating synergistic suppression of HSV, one or herpes simplex type one as its more formally known.

The primary endpoint for this trial will focus on fibromyalgia patients pain reduction and we're using the endpoint that has been used to assess all FDA approved fibromyalgia treatments to date.

Under the expert leadership of our clinical team I am pleased to report that all 41 sites participating in the fortress trial are fully operational and actively recruiting patients.

Based on this progress we can reconfirm our prior guidance that we expect to report out top line results from the fortress phase two b trial in mid 2022.

In parallel to the fortress phase two B trial are chronic toxicology studies in two species are progressing as planned.

These studies will be required by regulatory authorities before we are permitted to dose study participants with IMC, one for integrals of one year or more which we plan to do in our phase III program.

The chronic toxicology program has time to complete by the time the fortress study ends.

We will be able to propose a final phase III program to FDA.

Conclusion of our current study.

And finally, we are reaffirming that our current cash should provide the company with operational runway to the end of 2022 a.

A full six months following the planned announcement of the topline results from the ongoing fibromyalgia phase III trial.

With that brief update on our operational progress, let me turn it back over to our senior Vice President of Finance Angela Walsh to discuss our Q2 financial results Angela.

Thank you Greg I will begin today with our cash position as of June 32021, We had 21.8 million in cash as compared to $29.8 million.

At December 31, 2020, as Greg just mentioned, we expect our current cash to be sufficient to fund the companys operations since the end of 2022.

With respect to our income statement.

As a development stage company, we did not generate revenue during the three months ended June 32021 are in the year ago quarter.

We reported research and development expenses of $3.2 million for the.

Quarter ended June 32021, compared to $2.0 million to $10 million for the year ago quarter.

This increase in research and development expenses was primarily attributable to expenses for our <unk> clinical trial are chronic toxicology program and drug development and manufacturing call.

We reported general and administrative expenses of $1.1 million for the second quarter ended June 32021, as compared to $5 million for the year ago quarter.

This increase in general and administrative expenses was primarily attributable to call associated with being a public company.

We reported a net loss of $4.3 million for the second quarter ended June 32021, compared to a net loss of $7 million.

The year ago quarter.

I'll now turn the call back over to Greg.

Right.

Thank you once again Angela.

The unique fixed dose synergistic antiviral mechanism of our lead candidate IMC, one represents a completely new approach to treating fibromyalgia and potentially others somatic syndrome disorders.

Role of activated herpes virus as a potential catalyst in diseases like fibromyalgia and chronic Gi disorders is supported by both mechanistic and clinical data and.

Evidence of this unique approach can be seen in the fast track review designation granted by the FDA to IMC, one to treat other magic, which to the best of our knowledge represents the first time, a new drug candidate has been granted this designation for fibromyalgia treatment.

Encouragingly there is increasing recognition in the scientific community of the potential role of activated viruses like hsp, one triggering a wide range of morbidities, including fibromyalgia, heritable bowel syndrome, and fatigue related disorders.

Actively exploring the feasibility and the timing of executing additional HSV one targeted research programs to complement our existing fibromyalgia program and expect to communicate said plans during the second half this year we.

We are committed to frequent and proactive outreach to the investment community as well as the medical community as we progress our journey to try and improve treatment standards for hundreds of millions of fibromyalgia patients across the globe.

Operator, we are now ready for questions.

Thank you the floor is now open for questions. If you do have a question. Please press star one on your telephone keypad at this time, if you're using a speaker phone. We ask that you pick up your handset will posing your question to provide the best sound quality again, ladies and gentlemen, if you do have a question or comment Please press star.

One on your telephone keypad at this time, please hold a moment, while we poll for questions.

We will take our first question from David balance with Zacks small cap research. Please go ahead.

Hey, good morning, everyone.

I'm curious in terms of patient enrollment and have you seen any type of drop off with the recent increase in covid cases around the country.

Hi, David This is Greg Duncan I'll take that first question and thank you for joining today.

Interestingly enough we have progressed as I mentioned in the call with getting all of our sites operational we have a really nice pace going on.

We've enrolled slightly over 100 patients in the trial over the first few months.

And we do not anticipate per se or major changes in the enrollment rate based on Covid based on our experience and the team's experience the clinical teams experience.

Last year during the first outbreak fibromyalgia research is one of the few categories that actually progressed as it had prior to Covid.

And so based on prior experience, we are not forecasting that but certainly we will keep an eye on that and I think the reason. These patients continue to show up really is reflected in the severity of their disease the pain fatigue.

The morbidity and mortality that's associated with disease is quite significant and as a as a result. These patients are quite committed to getting care that can improve their own standards. So while we're not forecasting them, but we're starting to keep an eye on it but we have not seen any delays to date David.

Okay great.

Now in terms of.

Other programs that you plan on taking into the clinic in front I was wondering if you could just talk a little bit about what goes into determining basically what those next programs will be.

Yes, so excellent question.

The.

Impetus for moving into somatic syndrome disorders is based on the experience of our founder Dr. William prison.

Using combination of anti viral therapies to treat somatic syndrome disorders, like irritable bowel syndrome, fibromyalgia and fatigue related disorders.

We also come the research and look at prior work to determine where herpes simplex type one has been implicated in different diseases and you can see in the medical literature that herpes simplex one is.

Hypothesized postulated if you will to be involved in a number of different diseases and the two that have reached the top of our queue behind fibromyalgia are actually irritable bowel syndrome.

And fatigue related disorders in particular, as you're probably well aware, we announced in February a collaboration with Dr. Michael Campbell, Larry of the Mayo clinic.

To design, a phase Iia proof of concept study in irritable bowel syndrome.

And this was selected for a number of reasons, notably our founders experienced with these particular patients you may recall that the University of Alabama tissue biopsy study that was presented at CDW.

Adjusted disease week meeting.

In the spring.

Actually highlighted the activation of herpes simplex type one in chronic Gi disorders. So there's a mechanistic tie them that's been.

Ah postulated its been presented at scientific meetings, but I hope that.

That data gets published.

And I think it's safe to say that most people assessing the irritable bowel syndrome marketplace. Note. There is significant unmet need in ibs treatment much like there is some fibromyalgia. So this is an excellent target.

And I would mention.

From our phase Iia trial that I am too much significantly reduced fiber miles related pain.

Which we believe provides us with a great signal for the potential utility of IMC wanted to retreat Ibs pain.

Other area. We're looking at are fatigue related disorders. These are also implicated in the medical literature as potentially being activated and replicating as a potential root cause of fatigue related disorders that includes chronic fatigue syndrome.

And as you May know there is increasing evidence that fatigue is the number one symptom amongst the covid long haul or population and that's another area that we're exploring to see whether or not this particular mechanism might provide some utility for those patients who are desperate for therapies right now because it's truly an emerging medical need.

And the recent literature in that particular space suggests that it may not actually be the coronavirus that may be the other viruses Epstein Barr herpes simplex type one.

<unk> that are breaking through and your immune system gets challenged by the coronavirus and as a consequence, you're seeing the breakthrough of other <unk>.

Potential symptom manifestation. So the upshot is we just mentioned in the brief update as we will be back to folks like yourself to the investment community to update on our plans to progress.

Programs in those particular areas as complements to the landmark fibromyalgia program.

We'll report that back out in the second half of this year.

Does that answer your question David.

Yes, it does thank you and I.

I have one follow up on that I guess I'm, just kind of curious what kind of reception you get it at scientific meetings. When you propose the theory of you know viral driven fibromyalgia. Another chronic disorders. I mean are the are the kols and experts in the field.

Open to this idea you get pushed back you know what kind of interactions go on there.

Yes, it's a great question David in fact, if you talk to our board members.

Dr. Richard Whitley and Dr. <unk> de La Rosa They will tell you. They were trained on these species. Many many years ago and the research kind of went dark if you will.

For many years and so there's a whole contingent of urologists that have actually been trained on this hypothesis and have been looking to test. This hypothesis and unfortunately, it was not pursued with the bigger that various therapeutics is pursuing that and so as a consequence, there is actually great receptivity to this thesis in the virology community.

And as evidence of broader interest in this we can see.

The folks that treat fibromyalgia because these are rheumatologists neurologists.

Hi interest.

Pain specialists are actually very intrigued and we actually had to turn down sites to participate in our phase II trial is evidence of that interest in this particular thesis.

And I think what really helps us make that case is to the best of our knowledge IMC ones fast track review designation, which we believe based on our knowledge is the first ever granted to a fiber miles a treatment candidate.

We believe validates the uniqueness of that claim for treating somatic syndrome disorders, like fibromyalgia, Gi disorders et cetera, and we think.

In addition to the FDA, that's why the biopsy research.

Referenced earlier to your Ibs question or other areas of interest question was accepted as a handful of late breaking live presentations that ptw, because it's a pretty exciting place to be and I think the general knowledge of the world about viruses and the impact of buyers is at an all time high right now so that.

Probably helps raise general awareness.

And then obviously with our activities focused on HSV, one we hope to continue to build on that momentum.

Yeah, Alright, great well I appreciate you taking the questions. This morning.

Thank you David.

As a reminder, ladies and gentlemen, if you do have a question or comment. Please press star one on your telephone keypad at this time.

Thats Star one on your telephone keypad, if you'd like to ask a question to join the queue.

There appear to be no further questions at this time, we'll turn it back to Mr. Duncan for closing remarks, Sir the floor is yours.

Yes, Thank you Karen and thank you all for attending this morning this quarter to update for various therapeutics as we mentioned.

We believe we are truly pursuing a very novel approach of delivering combination anti viral therapies to patients who suffer from chronic debilitating diseases.

And we are targeting targeting a very large market opportunity with fibromyalgia.

Or if you believe the epidemiology data and we do there are literally hundreds of millions of patients.

Suffering from fibromyalgia.

And evidence of that novelty as can be seen on a fast track review designation, which I just mentioned in response to David's question. The team and the board has extensive drug development experience for many category, leading therapies and notably that experience includes development and commercialization of two of the three drugs ever approved and commercialized treat fibromyalgia here in the U S.

And as I mentioned, we do think this target of HSV, one or herpes simplex type one virus inhibition holds great promise for other somatic syndrome disorders.

Yes in particular lipid syndrome as being the top of the queue.

We will report back on our plans to pursue those opportunities in the second half of this year be safe and certainly keep an eye on the various newsfeed with updates over the next quarter and our next presentation will be at the S and small Investor Conference on August 19th to create like to dial them in here or maybe just update so thank you very much.

Ladies and gentlemen, this does conclude today's teleconference. We thank you again for your participation you may disconnect. Your lines at this time and have a great day.

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