Virios Therapeutics, Inc. (VIRI) on Q1 2021 Results - Earnings Call Transcript
Company Representatives: Greg Duncan - Chief Executive Officer Michael Gendreau - Chief Medical Officer Angela Walsh - Senior Vice President of Finance and Treasurer Ralph Grosswald - Vice President of Operations
Operator: Good morning, and welcome to Virios Therapeutics First Quarter 2021 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 and Treasurer of Virios Therapeutics; please proceed Angela.
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, first quarter financial results, as well as to provide you with an update on the operational progress we have made during the first four months of 2021. 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. Dr. Mike Gendreau our Chief Medical Officer will bring further specifics on our Fibromyalgia Phase 2b study and our chronic toxicology programs, and then I will return to review our Q1 financial results. In addition, Ralph Grosswald, our VP of Operations is with us for the question-and-answer portion of the call.
Greg Duncan: Thank you Angela and good morning everyone. We appreciate you joining us on the call today, because we are excited to provide you with an update on the substantial progress the Virios Therapeutics team has made since our last update this past March. During the past two months the team has achieved the following key milestones: Under the expert leadership of our Vice President of Operations, Ralph Grosswald, we have manufactured drug supply and are shipping IMC-1 and matching placebo for both the Phase 2b Fibromyalgia clinical program and our Chronic Toxicology study to support commencement of both programs as planned this quarter. Our goal is to commence enrolment of patients in our fibromyalgia Phase 2b trial this quarter and project to reach full enrolment by the end of 2021, with top line results expected in quarter two 2022. We are pleased to announce that new analysis of results from our Phase 2 fibromyalgia research have been accepted for presentation at two major medical meetings this spring. The first presentation will be at the European Congress of Rheumatology, otherwise known as EULAR in early June. Data presented at EULAR will focus on efficacy analyses of key secondary endpoints in our completed Phase 2 study, including fibromyalgia impact questionnaire response items. Multiple domains important to patients including pain and fatigue were found to be responsive to IMC-1 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 IMC-1 was unusually well tolerated in patients with fibromyalgia. Specifically IMC-1 treated patients had higher overall completion rates and lower rates of discontinuation due to adverse events as compared with placebo treated patients. Additionally, IMC-1 treated fibromyalgia patients’ experienced statistically significant improvement on both the primary endpoint of pain reduction and a battery of secondary endpoint measures, supporting all rationale for further development of IMC-1.
Michael Gendreau : Thank you, Greg. As a refresher, in the FORTRESS 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 IMC-1 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 patients’ self-reported pain, the end point that has been used to assess all fibromyalgia 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 smartphone. In addition to assessing the patient's pain reduction, we will also be assisting IMC-1’s ability to improve symptoms of fatigue, sleep disturbance, overall global health status and improved patient function, as well as IMC-1’s overall tolerability as compared to placebo.
Angela Walsh: Thank you, Mike. I will begin today with the balance sheet and more specifically cash. As of March 31, 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 through the end of 2022, which is an estimated six months following the plan announcement of the topline results from our FORTRESS study. With respect to our income statement, as a development stage company, we did not generate revenues during the three months ended March 31, 2021 or during the three months ended March 31, 2020. We reported research and development expenses of $1.71 million for the first quarter ended March 31, 2021 compared to point $0.3 million for the first quarter ended March 31, 2020. The increase in research and development expenses quarter-over-quarter, were primarily attributable to expenses for our FORTRESS clinical study and our chronic toxicology program, both of which commenced in this quarter as Mike just mentioned.
Greg Duncan : Thank you once again Angela and thank you for everybody who's attending today's update. As I'm sure you can tell, the Virios team is very encouraged by the strong interest in the medical community and our novel antiviral treatment approach involving fibromyalgia as well as IBS. The fibromyalgia market opportunity in particular is large and market research suggests that fibromyalgia patients and physicians treating fibromyalgia patients are dissatisfied with the existing fibromyalgia treatment options. The unique fixed does, synergistic antiviral mechanism of IMC-1 represents a completely new approach to treating fibromyalgia and potentially other somatic symptom disorders. This novel approach is supported by both of fibromyalgia Phase 2a data and the fast track review designation granted to IMC-1 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. IMC-1 has already demonstrated clinical benefits in a Phase 2a fibromyalgia trial using the pain reduction assessment FDA uses to evaluate new therapies for fibromyalgia indication. As previously communicated, the Virios Therapeutics team and our Board of Directors have extensive experience developing and commercializing category leading medicines. This expanded team has been involved in the development and commercialization of Lyrica and Savella, two of only three drugs previously approved by the FDA for the treatment of fibromyalgia. The experience of the Virios Therapeutics Directors and Officers has enabled us to deliver 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.
Operator: Thank you.
Greg Duncan : So the first question we will cover up today is one we get quite frequently, and that question is as follows: What other diseases are the Virios team exploring as research opportunities for IMC-1? Mike, I'll turn that question over to you, as you're probably best placed to handle that one. Thank you.
Mike Gendreau : Sure Greg. So consistent with what we previously press released and talked about with a collaboration with Mayo Clinic, we see Irritable Bowel as a likely next condition we would be exploring for future indication for IMC-1. IBS is we believe the logical next candidate for our Proof of Concept trial based on a couple 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 something that all the treatments are optimum for. And second, the Universality of Alabama Tissue Biopsy Study that's been presented at a conference shortly, demonstrated the presence of active HSV-1 replication in IBS patients, as compared to control patients, and we know that the IBS community is looking for better treatment options for the pain component of IBS and regulatory authorities have started requiring studies in IBS to incorporate better assessments of pain improvement in their study designs. And we know from our fibromyalgia Phase 2a study that IMC-1 significantly reduced fibromyalgia related pain, which we believe provides us with the signal for the potential utility of IMC-1 to treat IBS related pain. We'll be exploring opportunities with FDA in the fall and we are looking at the necessity to develop an IND to consider that further. So I think that covers it, Greg.
Greg Duncan : Thank you, Mike. And I would just add, the study design we’ve aligned with Dr. Michael Camilleri would likely require additional financing. So I just wanted to get that clear as we consider progressing a second program as a compliment to the fibromyalgia program. Second question is one we often get and I think you covered this Angela, but it's probably worth reiterating. Does your existing cash enable you to get through Phase 2b fibromyalgia trial topline results?
Angela Walsh : Yes Greg. As mentioned earlier, the proceeds from our December IPO provide operational runway through the end of 2022, which is a full six months beyond the FORTRESS trial top line results. Presuming success in the FORTRESS trial, we will use this time to engage the FDA to align on the IMC-1 Phase 3 program and financing requirement. We believe an asset with the commercial potential of a new fibromyalgia treatment will draw interests from other life science companies. As such, we can also use this time to evaluate external party interest in IMC-1. But clarity on Phase 3 requirements and having assessed external partnership interest, we can then choose the best value of maximizing approach for our shareholders via that alone or in partnership as we advance IMC-1 development and commercialization.
Greg Duncan : Thank you, Angela. Any additional questions?
Operator: Nope, there are no additional questions at this time. So I would like to turn the call back to Greg Duncan for closing remarks.
Greg Duncan : Thank you very much, Joe. Hopefully you can get a sense of the teams’ progress over the first four months of 2021. We’ve made great progress on the manufacturing front, preparing over 40 sites to execute our fibromyalgia Phase 2b results, finalize the protocol and we're preparing to enroll patients as Mike mentioned later this quarter as planned. You can see we are starting to raise the profile of Virios and our ground breaking research. Fibromyalgia data have been accepted for presentation at both EULAR and IASP in June. And furthermore our GI biopsy data have been accepted as a late breaker presentation later this month at Digestive Disease Week, which is the largest GI focused meeting in the country. This is significant in our view, because only a handful of presentations are accepted as “late breakers,” so again, highlighting the importance of this mechanism is a potential treatment for diseases beyond fibromyalgia. And we now turn our attention to enrolling the 460 patients in our Phase 2b fibromyalgia trial over the next eight months, with the goal of delivering topline results in June of 2022. If you remember nothing else from today's call, there is three things I’d like you to remember: the fibromyalgia market place, which we're looking to address is quite large and dissatisfied. We have a novel antiviral approach that’s supported by data and as Angela just mentioned, that program is fully funded. We have an experienced team who have run this race before. Between the team and the Board of Directors we’ve developed and/or commercialized two of the three drugs have been approved for patients with this particular condition. 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!
Operator: This ends today’s conference. You may disconnect your lines at this time. Thank you very much for your participation. Have a great day!
