Virios Therapeutics, Inc. (NASDAQ:VIRI) Q3 2023 Earnings Call Transcript

Greg Duncan: Sure. And good morning, Sean. Thank you for joining. The plan will be to secure FDA guidance. As I mentioned during the course of today’s presentation, we have developed a briefing book. As you probably know, Sean, but just for the edification of others, when you’re opening up an IND, you submit questions to the FDA, you get their feedback about things like what’s the primary endpoint? We think fatigue, for example, should be the primary endpoint. It’s the most dominant symptom in long COVID. What are the sample sizes, et cetera, required to advance development? And we should get feedback sometime in the next four to eight weeks. We hope to have it in 2023. But there’s not a timeline per se on getting specific alignment with FDA here.

So, that could bleed into the very early part of 2024. Once we have those requirements in hand, we will do two things. One is begin planning the proposed Phase 2b study. And secondarily, we will open up the partnership discussions on a more fulsome basis because now we know what the target is moving forward, presuming, again, alignment with FDA on the next steps of regulatory pathways, shall we speak, endpoints, duration, et cetera. And then we will likely use the outputs, the treatment effect size, the sample size, et cetera, that will be generated by the BHC study that is ongoing, which we expect to read out sometime in early 2024 as the basis for finalizing the study design for the next phase, the 2b study in long COVID. Does that answer your question, Sean?

Sean Lee: Yep. That’s very helpful. Thank you.

Operator: [Operator instructions]. Thank you. That concludes our Q&A session. I’ll now hand the conference back to Greg Duncan for closing remarks. Please go ahead.

Greg Duncan: Thank you very much, Matthew. Hopefully, you get a sense that these are very exciting times for Virios Therapeutics. We’re on the cusp of progressing two very novel programs, IMC-1 for fibromyalgia, and IMC-2 for long COVID. These are two very novel, potentially game-changing new therapies to advance care for patients suffering the debilitating effects of both fibromyalgia and long COVID. And we really think with continued success, we have some very exciting value appreciation for various stockholders. We, as we always do, will commit to very timely update on progress on both research, regulatory, and the partnership front, as we progress through the balance of 2023 and into early 2024. We thank you for attending today’s call.

Operator: Thank you, everyone. This concludes today’s event. You may disconnect at this time and have a wonderful day. Thank you for your participation.