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spk03: Good morning and welcome to Vireos Therapeutics Third 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, SBP Finance Treasurer, Vireos Therapeutics. 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 Vireo Therapeutics' third quarter financial results, as well as to provide you with an update on the operational progress we have made during the first nine 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. and then I will return to review our third quarter financial results. In addition, Ralph Goswald, our 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 involve 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 of 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 statement section in our financial results release issued this morning for more information. It is now my pleasure to turn the call over to our CEO, Greg Duncan.
spk05: Thank you, 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 the substantial progress the Vireo Therapeutics team has delivered over the past few months. Before updating you on our operational progress, I thought it might be useful to overview the Vireos Therapeutics value proposition for those new to the Vireos story and or for those attending a very quarterly update for the very first time. Vireos Therapeutics Incorporated is developing novel combination antiviral therapies to treat patients suffering from chronic debilitating diseases such as fibromyalgia, irritable bowel syndrome, and fatigue-related disorders. The focus of our lead research program is on improving clinical outcomes for patients diagnosed with fibromyalgia. The fibromyalgia patient community, and therefore market, is actually quite large, with estimates suggesting over 200 million people worldwide meet the diagnostic criteria for fibromyalgia. This large market is unfortunately very dissatisfied, largely due to the poor tolerability of the three FDA approved fibromyalgia medicines. Our lead antiviral development candidate is oral IMC-1, a dual mechanism combination antiviral therapy. IMC-1 is formulated as a tablet, dosed twice daily, and has already demonstrated statistically significant pain reduction and tolerability better than placebo in a previously completed Phase IIa fibromyalgia trial. Based on significant unmet need in the fibromyalgia treatment armamentarium, the novelty of our antiviral approach and our strong existing clinical data, IMC-1 was granted fast-track review designation by FDA, the first such designation for a fibromyalgia development candidate to the best of our knowledge. Based on the success of our Phase IIa fibromyalgia study, we commenced our ongoing fibromyalgia Phase IIb fortress trial in quarter two of this year. We refer to this trial as FORTRESS, which stands for Fibromyalgia Outcome Research Trial evaluating synergistic suppression of HSV-1. We expect to report top-line results from this ongoing trial in quarter three of 2022. Our research programs are managed by a terrific team and a board of directors who have extensive drug development and commercialization experience, including experience managing several household main medicines. Importantly, our executive team and board have been involved in the development and commercialization of two of the three previous FDA-approved medicines to treat fibromyalgia. And finally, through prudent cash management, we presently project that we have ample cash to run operations into quarter one of 2023. In short, we have a novel antiviral treatment candidate targeted towards improving care for a large, dissatisfied cohort of fibromyalgia patients. Our ongoing Phase IIb fibromyalgia program is fully funded and is being managed by a team who have successful experience developing and garnering FDA approval for previous approved fibromyalgia treatments. Within this broader context, let's move to our quarter three update. Over the past several months, the team has achieved the following key milestones. I'm very pleased to report that we have enrolled over 200 of the 460 patients we are targeting for inclusion in our landmark Phase IIb Fortress clinical trial. The primary endpoint for this trial will focus on reduction in pain, the very same endpoint that has been used to assess all previously approved FDA medicines to date. In parallel to the Fortress Phase 2b trial, our chronic toxicology studies in two species are progressing as planned. The results of these studies will be required by regulatory authorities before we are permitted to dose study participants with IMC1 for intervals of one year or more, which we plan to do in our Phase 3 program. The chronic toxicology program is timed to complete by the time the Fortress trial is completed, such that we will be able to propose a final phase three program to FDA at the conclusion of the current study. I'm also very pleased to announce that we have filed the second IMC-1 investigational new drug application with FDA. This new quote unquote IND is focused on exploring the utility of IMC-1 in treating patients diagnosed with Irritable Bowel Syndrome, which you may know as IBS. Development of this regulatory filing is the first deliverable from our IBS collaboration with Dr. Michael Camilleri of the Mayo Clinic, announced in quarter one of this year. As a precursor to exploring the clinical utility of IMC1 for treating IBS, Virios Therapeutics executed a tissue biopsy study to better understand the role of activated HSV1 in patients with chronic GI disorders. These data were actually submitted to the Digestive Disease Week Annual Scientific Congress and accepted as a quote unquote late breaker submission for presentation to the entire DDW Congress participants. Dr. Carol Duffy's presentation of these data highlighted the presence of activated replicating HSV-1 in GI biopsy tissue harvested from patients diagnosed with a chronic GI disorder. Identifying HSV-1 activation in IBS patients is the first step in providing proof of the potential of the herpes simplex 1 virus as a potential root cause of IBS, much like it is in fibromyalgia. With mechanistic data in hand, we believe the time is right to formally explore the potential clinical benefits of IMC1's synergistic antiviral effects in delivering positive clinical outcomes for IBS patients. Finally, we project that our current cast position should provide the company with operational runway into quarter one, 2023, approximately six months following the planned announcement of the top line results from a fibromyalgia phase 2B fortress trial. This has been achieved through continued prudent management of cash over the first nine months of 2021. With that update on our operational progress, let me turn it back over to our Senior Vice President of Finance, Angela Walsh, to discuss our quarter three financial results.
spk00: Angela? Thank you, Greg. I will begin today with our cash position. As of September 30th, 2021, we had $19.2 million in cash as compared to $29.8 million as of December 31st, 2020. As Greg just mentioned, we expect our current cash to be sufficient to fund the company's operations into quarter one of 2023. With respect to our income statement, as a development stage company, we did not generate revenue during the three months ended September 30th, 2021 or in the year-ago quarter. We reported research and development expenses of $3 million for the third quarter ended September 30th, 2021 compared to $0.1 million for the year-ago quarter. This increase in research and development expenses was primarily attributable to expenses for our Fortress clinical trial, our chronic toxicology program, and drug development and manufacturing costs. We reported general and administrative expenses of $1.1 million for the third quarter ended September 30th, 2021, as compared to $2.5 million for the year-ago third quarter. This decrease in general and administrative expenses was primarily attributable to compensation expense recognized in 2020 for the issuance of membership interests to the company's founder, offset by an increase in cost associated with being a public company. We reported a net loss of $4.1 million for the third quarter ended September 30th, 2021, compared to a net loss of $2.7 million for the year-ago quarter. I'll now turn the call over to Greg to moderate the question and answer portion of today's call.
spk05: Greg? Thank you again, Angela. The unique fixed dose synergistic antiviral mechanism of our lead candidate, IMC1, represents a completely new approach to treating fibromyalgia and potentially other somatic syndrome disorders. The role of activated HSV1 virus as a potential catalyst in diseases like fibromyalgia, and chronic GI disorders is supported by both mechanistic and clinical data. And the fast track review designation granted by FDA to IMC1 for the treatment of fibromyalgia is the first time, to the best of our knowledge, for a new drug candidate in the fibromyalgia research vertical. If the profile of IMC1 that has emerged from our Phase IIa study holds up, we believe our novel antiviral combination could be a game changer for patients and their doctors, not to mention for viriose shareholders. Encouragingly, there is increasing recognition in the scientific community of the potential role of activated viruses like herpes simplex type 1, triggering a wide range of morbidities, including fibromyalgia and IBS. As mentioned earlier, we are pleased with the progress of our Phase IIb Fortress trial, and we expect top-line results from this landmark trial in Quarter 3, 2022. We are committed to frequent and proactive outreach to the investment community as well as the medical community as we progress our journey to improve treatment standards for hundreds of millions of fibromyalgia patients across the globe. Operator, we are now ready for questions.
spk03: Thank you. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. If you wish to leave the queue, You may press star two to withdraw. We do ask that if you are listening via speakerphone to please pick up your handset for optimum sound quality. Once again, if you have any questions or comments, please press star one now. Our first question today is coming from David Bouts at Zach's Small Cap Research. Your line is live. You may begin.
spk01: Hey, good morning, everyone. Thanks for the overview this morning, Greg. I was wondering, though, if you could maybe expand upon what the timelines are going to be for the IBS program, and then maybe if you could give kind of a broad overview of how you would envision the first clinical trial and that indication going.
spk05: Thank you, David. I appreciate you joining on the call this morning. I'll take the first question first relative to timelines. As announced this morning, we filed the IND. This morning, we expect to get feedback sometime by the end of this year or early part of next year. Presuming alignment with FDA, we would look then to catalyze drug supply and likely start the trial probably Q2, call it middle of 2022. It takes a little bit of time to get all the investigators together. As you know from our fibromyalgia experience, we like to do live investigators meetings to train people. And so I would forecast first patient, first visit probably close to Q2 of next year. The size and scope of the trial would be probably safe to say consistent with the completed fibromyalgia phase 2A study. That was a study, as you may recall, of about 140 patients, roughly 70 per arm, maybe 60 or 70 patients per arm, so between 120 and 140 patients. And we'll progress that study from Q2, probably take on the order of nine months or so to recruit the patients. somewhere thereabouts, so I would expect data sometime in the first half of 2023.
spk04: Okay, great.
spk01: I'm curious, in regards to the Fortress trial, are you pleased with how enrollment is going? Is it kind of how you thought it would go? Is it faster, kind of on pace, where you thought it would be? And then are you getting any type of feedback from the clinicians as far as what patients feel about this approach? Because it is novel. Are they excited about it? Are you hearing anything about that?
spk05: Yeah, so both good questions. The FORTRESS trial is enrolling basically as we had hoped. I will say it's real kudos to Ralph who's on the line and Mike General and the rest of the clinical team. You probably, as you see other companies, many companies are struggling. due to COVID-related issues. Sites are looking for study coordinators. Patients are neglecting to show up for office visits. And so some of our colleagues, if you will, at the industry level are really struggling. And by and large, knock on wood, things are progressing broadly as we had hoped. We have over 200 patients enrolled in the trial to date. There are other trials in the category that have been enrolling since 2018, 2019. As you know, we started earlier this year, and we already have 200 patients in the trial. And I believe the fact that we've had such a robust effort is in large part due to the hands-on role of the clinical team, Mike, Ralph, Channing, et cetera, but also because people are truly excited about this approach. You know, most of the drugs, all of the drugs that are approved by FDA are CNS-mediated, so they kind of fit in a basket together, and they deliver good results but are not well-tolerated. I think the fact that the... The approach here is different, addressing what we believe is a potential root cause of the disease and the profound nature of the response. You know, we saw reduction in pain, improvement in anxiety, reduction in depression, improved functionality, and a tolerability profile here in the Phase IIa that was better than placebo. Patients and docs were pretty excited about it, and I think that's actually contributed to the robust recruitment to date. because these patients are very knowledgeable. They've had the disease for a long time. They understand the therapies. Most of them have cycled through all of the approved therapies and likely some of the development candidates. And they understand that tolerability is no small thing. There are drugs that reduce pain, but there's really not been a game changer, if you will, in our view, that delivers both efficacy and the tolerability. And so I think that's helped contribute to the robust recruitment rate. You know, we have guided to mid- 2022 results since we did the IPO. And, you know, I think it's safe to say we're confident with results in Q3 2022. And that's our guidance and we're standing by.
spk01: All right, great. Appreciate you taking the questions this morning.
spk04: Yeah, thank you, David. Really appreciate you asking the questions.
spk02: Thank you. Once again, ladies and gentlemen, if you have any questions or comments, please press star 1 now. We have no further questions in the queue at this time.
spk03: I'd now like to turn the call back over to CEO Greg Duncan.
spk05: Thank you, Kate. Thank you guys for attending this morning. We're pretty excited as you can probably sense about the potential of IMC1. in fibromyalgia and look to explore the potential utility of IMC1 in irritable bowel syndrome, presuming alignment with FDA on a forward program. And simply put, we are targeting very large dissatisfied markets. We have really terrific data, both clinical and mechanistic, to support our thesis. Look forward to continuing progress on both the fibromyalgia and IBS fronts to deliver value for patients. which I probably don't have to tell you, will ultimately deliver value to shareholders. And we're very committed to that mission. We do appreciate your interest in video therapeutics. Thank you to the team for all their great work, and we look forward to updating you as we continue to progress our research pipeline.
spk04: Thank you.
spk02: Thank you, ladies and gentlemen. This does conclude today's event. You may disconnect at this time and have a wonderful day. Thank you for your participation.
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