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spk03: Good morning and welcome to Vireos 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 Vireos Therapeutics.
spk05: Please proceed, Angela.
spk00: 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 therapeutic 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 Genro, our Chief Medical Officer, will bring further specifics on our fibromyalgia Phase IIb study and our chronic toxicology programs. And then I will return to review our Q1 financial results. In addition, Ralph Groswald, our VP 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. 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. Greg?
spk02: Thank you, Angela, and good morning, everyone. We appreciate you joining us on the call today, as we are excited to provide you with an update on the substantial progress the Vireos 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 Crosswald, we have manufactured drug supply and are shipping IMC-1 and matching placebo for both the Phase IIb Fibromyalgia Clinical Program and our 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 2b trial this quarter and project to reach full enrollment by the end of 2021, with top-line results expected in Quarter 2, 2022. We are pleased to announce that new analyses 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 ULAR, in early June. Data presented at ULAR will focus on efficacy analyses of key secondary endpoints in our completed Phase II 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 our rationale for further development of IMC1. With regard to pipeline expansion, we have progressed our IBS-focused research collaboration with Dr. Michael Camilleri of the Mayo Clinic, and we'll look to engage FDA in the fall as regards to our proposed plans to assess the utility of IMC1's HSV1 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 2b 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 1 virus as a potential root cause of chronic gastrointestinal disorders. Furthermore, this presentation will provide visibility on the potential utility of combination antiviral drug therapies, such as IMC1, for patients diagnosed with Rome IV criteria functional GI disorders, including IBS. This is a noteworthy achievement, as 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 and patented approach for treating diseases associated with a virally triggered or maintained immune responses. Let me turn the call over to Dr. Genro to update you on our Phase IIb Fibromyalgia Trial, which is branded as the Fortress Study. FORTRESS stands for Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1. Mike?
spk01: 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 patient self-reported pain, the endpoint 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 assessing IMC1's ability to improve symptoms of fatigue, sleep disturbance, overall global health status, and improved patient function, as well as IMC1's overall tolerability as compared to placebo. The Vireos 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 of the sites that attended these training meetings. Based on industry standard fibromyalgia 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. While we cannot completely rule out recruitment delays related to events such as COVID, We have observed that in general, recruitment rates in fibromyalgia 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. These studies will be acquired by regulatory authorities before we are permitted to dose participants with IMC1 for intervals of one year or more, as we plan to do during our phase three program. The chronic toxicology program is timed to complete by the time the FORTRESS study does so that we will be able to propose a final phase three 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.
spk00: 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 through the end of 2022, which is an estimated six months following the plan announcement of the top line results from our fortress 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 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 $.03 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. 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 million for the first quarter ended March 31, 2021, compared to a net loss of half a million dollars for the first quarter ended March 31, 2020. I'll now turn the call back over to Greg to moderate the question and answer portion of today's call. Greg?
spk02: Thank you once again, Angela, and thank you for everybody who is attending today's update. As I'm sure you can tell, the VARIOS team is very encouraged by the strong interest in the medical community and our novel antiviral treatment approach in both 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 existing fibromyalgia treatment options. The unique fixed dose synergistic antiviral mechanism of IMC1 represents a completely new approach to treating fibromyalgia and potentially other somatic syndrome disorders. This novel approach is supported by both our fibromyalgia phase 2a data and the fast track review designation granted to IMC1 to treat fibromyalgia, which to the best of our knowledge represents the first time a new drug candidate has been granted this designation for a 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 a fibromyalgia indication. As previously communicated, the various 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 various 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. Our next presentation will be tomorrow at the Benzinger Global Small Cap Investor Conference. The related webcast will be available in the investor section of the Virios website accordingly. Operator, we are now ready for questions.
spk03: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate that your line is in the queue. If you would like to remove your question from the queue, please press star 2. 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.
spk02: So the first question we will cover off today is one we get quite frequently, and that question is as follows. What other diseases are the Vireos team exploring as research opportunities for IMC1? Mike, I'll turn that question over to you as you're probably best placed to handle that one. Thank you.
spk01: Sure, Gary. So consistent with what was 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 a future indication for IMC1. IBS is, we believe, 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 something that all the treatments are optimum for. And second, the University of Alabama tissue biopsy study that's being 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 IMC1 significantly reduced fibromyalgia-related pain, which we believe provides us with a signal for the potential utility of IMC1 to treat IBS-related pain. We'll be exploring the opportunities with FDA in the fall, and we are looking at, you know, the necessity to develop an IMD to consider that further. So I think that covers it, Greg.
spk02: Thank you, Mike. And I would just add the study design we've aligned with Dr. Camilleri on would likely require additional So I just want to make that clear as we consider progressing a second program as a complement 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 top line results?
spk00: 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 three program and financing requirements. We believe an asset with the commercial potential of a new fibromyalgia treatment will draw interest from other life science companies. As such, we can also use this time to evaluate external party interest in IMC-1. With clarity on Phase 3 requirements and having assessed external partnership interest, we can then choose the best value-maximizing approach for our shareholders, be that a loan or in partnership, as we advance IMC1 development and commercialization.
spk05: Thank you, Angela.
spk04: Any additional questions?
spk03: No, there are no additional questions at this time. So I would like to turn the call back to Greg Duncan for closing remarks.
spk02: Thank you very much, Joe. Hopefully you can get a sense of the team's 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, finalized 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 Vireos and our groundbreaking research. Fibromyalgia data have been accepted for presentation at both EULA 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 quote unquote late breakers. Again, highlighting the importance of this mechanism as a potential treatment for diseases beyond fibromyalgia. And we now turn our attention to enrolling the 460 patients in our Phase IIb fibromyalgia trial over the next eight months with the goal of delivering top-line results in June of 2022. If you remember nothing else from today's call, there's three things I'd like you to remember. The fibromyalgia marketplace, 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 ever 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.
spk05: Thank you and have a very good day. This ends today's conference. You may disconnect your lines at this time. Thank you very much for your participation. Have a great day.
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