Q1 2021 Virios Therapeutics LLC Earnings Call

[music].

Ladies and gentlemen, thank you for your patience, we will be starting momentarily again, thank you for your patience.

[music].

Good morning, and welcome to various therapeutics first quarter 2021 financial results conference call.

Please be advised for today's call is being recorded at the company's request at this time I would like to turn the call over to Angela Walsh, SVP Finance and Treasurer of Therapeutics. Please proceed Angela.

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 first quarter financial results.

Well, if I deal with an update on the operational progress we have made during the first for my F. 2021.

Please note that our financial results press release is now available on our website.

Well start todays call with our CEO, Greg talking providing you with a brief update on our corporate progress during the past quarter.

My General our Chief Medical Officer will bring for specifics on our fall from the Alger Phase two B study and our chronic toxicology program.

And then I will return to review our Q1 financial results.

In addition, Ralph Boswell, our VP of operations.

With us for the question and answer a question 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 see the forward looking statements disclaimer 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 correct.

Thank you Angela and good morning, everyone. We appreciate you joining us from our call today, because we were excited to provide you with an update from the substantial progress for various therapeutics team has made since our last update this past March.

During the past two months for team has achieved the following key milestones.

Under the expert leadership of our vice President of operations rough crosswalk.

Manufactured drug supply and our shipping I M C. One and matching placebo for both the phase two b fibromyalgia clinical program.

Chronic toxicology studies to support commencement of both programs as planned this quarter.

Our goal is to commence enrollment of patients in our fibromyalgia phase two b trial this quarter and project to reach full enrollment by the end of 2021.

Top line results expected in quarter two 2022.

We're pleased to announce that new analyses of results from our phase II Fibromyalgia research have been accepted for presentation at two major medical meetings. This spring.

First presentation will be at the European Congress of Rheumatology, otherwise known as you lock in early June.

<unk> will focus on efficacy analyses of key secondary endpoints in a completed phase II study, including fibromyalgia impact questionnaire response items.

Multiple domains are important to patients, including pain and fatigue was found to be responsive to our M. C. One treatment.

The second presentation will be at the meeting of the International Association for the study of pain World Congress in mid June.

Data presented at this meeting will focus on safety findings and demonstrate that I M. C. One was unusually well tolerated in patients with fibromyalgia.

Specifically I M C. One treated patients had higher overall completion rates and lower rates of discontinuation due to adverse events as compared with placebo treated patients. Additionally.

Additionally, I am sure you weren't treated fibromyalgia patients experienced statistically significant improvement from both the primary endpoint of pain reduction and a battery of secondary endpoint measures supporting our rationale for further development of items they want.

With regard to pipeline expansion, we have progressed, our Ibs focused research collaboration with Dr. Michael Campbell, Larry of the Mayo Clinic, and we will look to engage F. D. A in the fall as regards to our proposed plans to assess the utility of our M. C. One H S. P. One viral inhibition as a potential treatment for patients with irritable bowel syndrome.

This will enable the team to focus on commencement of the fibromyalgia phase two b trial, this spring and summer.

On an important and related note. We were recently notified that our mechanistic Gi biopsy study was accepted for oral presentation at the 2021 digestive disease week Medical conference later this month.

This is the largest Gi focused meeting in the country. The accepted data was generated in collaboration with the University of Alabama and highlights the potential role of activated herpes simplex virus as a potential root cause of chronic gastrointestinal disorders for.

More of this presentation will provide visibility on the potential utility of combination antiviral drug therapies, such as IFC, one for patients diagnosed with room for criteria of functional Gi disorders, including Ibs.

This is a noteworthy achievement is only a handful of presentations are accepted as quote unquote late breaking news at this important conference.

These three upcoming presentations focused on all research at major medical conferences are an important part of our strategy to increase awareness in the scientific community about various and our innovative.

Our innovative and patented approach for treating diseases associated with virally triggered or maintained immune responses.

Let me turn the call over to Dr. General to update you on our face to be fiber miles and trial, which is branded as the fortress study for.

Ultra stands for fibromyalgia outcome research trial evaluating synergistic suppression of HSV one Mike.

Thank you Greg.

As a refresher in the <unk> trial, we plan to enroll approximately 460 patients aged 18 to 65, who will be randomized in a one to one ratio to receive either I M. C. One or placebo all of whom have been diagnosed using the 2016 American college of rheumatology diagnostic criteria for fibromyalgia.

The primary endpoint for this trial will focus on reduction in patient self reported pain. The end point that has been used to assess all firewalls you're treatments to date.

Pain reduction will be measured daily on a 24 hour recall numeric rating scale using an electronic diary application that the patient will fill out at home on their own smartphones in.

In addition to assessing the patient's pain reduction we will also be assessing IMC one's ability to improve symptoms of fatigue.

Weak disturbance.

Overall global health status and improved patient function as well as IMC once overall tolerability as compared to placebo.

The various therapeutics medical team successfully executed two in person investigator meetings in the month of April training investigators and their staffs from over 40 sites as we prepare investigators across the United States to execute the fortress trial, we were pleased with the engagement and enthusiasm for the sites that attended these training.

Meetings base.

Based on industry standard fiber module patient recruitment rates, we project recruiting patients throughout the balance of 2021 followed by a database lock and top line results, becoming available in the second quarter of 2022, well, we cannot completely rule out recruitment delays related to events such as COVID-19, we have observed that.

In general recruitment rates and firewalls, you research trials have not been significantly impacted by the pandemic to date.

In parallel we have commenced the first phase of our chronic toxicology studies in two species.

Studies will be required by regulatory authorities before we were permitted to dose participants with IMC one for intervals of one year or more as we've planned to do during our phase III program.

The chronic toxicology program has time to complete by the time. The fortress study does so that we will be able to propose a final phase III program to the FDA at the conclusion of this current study.

With that update on our research progress, let me turn it over to our SVP of finance Angela Walsh to discuss our first quarter financial results.

Thank you Mike.

I will begin today with the balance sheet and more specifically cash as of March 31st 2021, we had $24 $6 million in cash as compared to $29 $8 million as of December 31, 2020.

We expect our current cash to be sufficient to support the company's operational needs for at the end of 'twenty 'twenty, two which is an estimated six months. Following the plan announcement at the topline results from our study.

With respect to our income statement as a development stage company, we did not generate revenue during the three months ended March 31, 2021 or Darren day three months ended March 31 2020.

We reported research and development expenses of one point $71 million for the first quarter ended March 31, 2021 compared to $2.0 million to $3 million for that first quarter ended March 31 2020.

The increase in research and development expenses quarter over quarter for primarily attributable to the expenses for our fortress clinical study and a chronic toxicology program both of which commenced in this quarter as Mike just mentioned.

We reported general and administrative expenses of $1 $35 million for the first quarter ended March 31, 2021 as compared to $35 million for the first quarter ended March 31 2020.

The increase in general and administrative expenses for the quarter was primarily attributable to legal and accounting fees and other costs associated with being a public company.

We reported a net loss of $3.1 billion for the first quarter ended March 31, 2021, compared to a net loss of half a million dollars for the first quarter ended March 31st 2020.

I'll now turn the call back over to Greg to moderate a question and it is a portion of today's call Greg.

Thank you once again Angela and thank you for everybody who is attending today's update.

As I'm sure you can tell the various team is very encouraged by the strong interest in the medical community and our novel anti viral treatment approach in both fibromyalgia as well as the Ibs.

The fibromyalgia market opportunity in particular is large and market research suggests that fibromyalgia patients and physicians treating fibromyalgia patients are dissatisfied with existing fibromyalgia treatment options.

The unique fixed dose synergistic anti viral mechanism of IMC, one represents a completely new approach to treating fibromyalgia and potentially other somatic syndrome disorders.

Novel approach is supported by both our fibromyalgia phase Iia data and the fast track review designation granted the IMC, one to treat fibromyalgia, which to the best of our knowledge represents the first time, a new drug candidate has been granted this designation for fibromyalgia treatment.

I N C. One has already demonstrated clinical benefits in a phase Iia fibromyalgia trial, using the pain reduction assessment F. D. A uses to evaluate your therapies for fibromyalgia indication.

Previously communicated the various therapeutics team and our board of directors have extensive experience developing and commercializing category, leading medicines district.

This expanded team has been involved in the development and commercialization of Lyrica and Sadella.

Two of only three drugs previously approved by the FDA for the treatment of fibromyalgia.

The experience of the Rio Therapeutics directors and officers has enabled us to deliver on our operational objectives as planned to date.

We are committed to frequent and proactive outreach to the investment community as well as the scientific community.

As we progress our journey to improve treatment standards for hundreds of millions of fibromyalgia patients across the globe.

Our next presentation will be tomorrow at the Benzinger global small cap industrial conference for.

Related webcast will be available in the investors section of the various website accordingly.

Operator, we're now ready for questions.

Thank you.

We will now be conducting a question and answer session.

If he would like to ask a question. Please press star one on your telephone keypad and income.

Information tone will indicate that your losses in the queue.

If you would like to remove your question from the queue. Please press star two.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.

So the first question we will cover off today is one we get quite frequently and that question is as follows.

Other diseases are the various team exploring as research opportunities for IMC, one Mike I'll turn that question over to you as you are probably best placed to handle that one.

Sure Greg.

So it's consistent with what we've previously press released and talked about with our collaboration with Mayo clinic, we see irritable bowel as a likely next condition, we would be exploring for future indication for IMC one.

Ibs as are we.

We believe as the logical next candidate for a proof of concept trial based on a couple of factors.

We have open label data that was generated by our founder treating ibs patients, which showed promising results across multiple disease domains of ibs, including pain, which is.

It's something that all the treatments are our optimum for.

And second.

The University of Alabama tissue biopsy study that's been presented at a conference shortly demonstrated the presence of activated C. One replication in ibs patients as compared to control patients and we know that the address communities looking for better treatment options for pain component of Ibs and regulatory authorities have star.

Good for client studies in Ibs incorporate better assessments of pain improvement in their study design.

And we know from our say our firewalls as a phase Iia study the IMC <unk> significantly reduced foreign Roger related pain, which we believe proceed this provides us with a signal for the potential utility of IMC, one to treat ibs related pain.

Exploring the opportunities with FDA in the fall and we are looking at the necessity to develop an <unk> to.

Consider that for so.

I think that covers it Greg.

Thank you, Mike and I would just add.

The study design.

Aligned with Dr. Campbell, Larry on would likely require additional financing. So I just want to make that clear as we consider.

Progressing our second program is a complement to the fibromyalgia program.

Second question is one we are often getting I think you've covered this angela but it's probably worth reiterating does your existing cash enable you to get through phase two b fibromyalgia trial top line results.

Yes, Greg as I mentioned earlier the proceeds from our December I P. O provide operating operational runway through the end of 2022, which is a full six months beyond the fortress trial topline yourself.

Presuming success and the point. This trial, we will use this time to engage the FDA to align on the I N C. One phase III program and finally, a key requirement.

We believe an asset with a commercial potential of a new fab them as a treatment for dry interests from other life science companies.

As such we can also use this time to evaluate external party interest and IMT, one clarity on phase III requirement and having assessed external partnership interest. They can then choose the best value maximizing approach for our shareholders.

That alone or in partnership as we advance I N C. One development and commercialization.

Thank you Angela.

Yeah.

Any additional questions.

Well there are no additional questions at this time, so I would like to turn the call back to Greg Duncan for closing remarks.

Thank you very much Joe hopefully you can get a sense of the teams our progress over the first four months of 2021 a.

We've made great progress on the manufacturing front preparing over 40 sites to execute or fibromyalgia phase two b.

Results finalize the protocol and we are preparing to enroll patients as Mike mentioned, our later this quarter as planned.

You can see we are starting to raise the profile of various and or groundbreaking research fiber miles a day that had been accepted for presentation at both your low end I S. P. In June.

Furthermore, our G. I biopsy data have been accepted as a late breaker presentation. Later this month at digestive disease week, which is a low just Gi focused meeting in the country. This is significant and all of you because only a handful of presentations were accepted as quote unquote late breakers. So.

Again, highlighting the importance of this mechanism as a potential treatment for diseases beyond trouble manager.

We now turn our attention to enrolling 460 patients in our phase to beef up our miles per trial over the next eight months with the goal of delivering topline results from June of 2022.

You remember nothing else from today's call. There's three things that I can remember for fibromyalgia marketplace, which we're looking to address is quite large and dissatisfied we have a novel anti viral approach that's supported by data and it's Angela just mentioned that program is fully funded we have an experienced team who run this race before between the team and the board of directors.

Will be developed into a commercialized two of the three drugs have been approved for patients with this particular condition we.

We appreciate your support.

And also your interest in this journey as we look to transform the standard of care for literally hundreds of millions of fibromyalgia patients across the globe.

Thank you and have a very good day.

This won't Suez Conference you may disconnect. Your lines at this time. Thank you very much for your participation and have a great day.

Yeah.