Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
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| But we do believe if we show statistical significance versus placebo and we see replication of data that has been generated prior to our research showing NSAIDs don't really move the needle on fibromyalgia, antivirals independently don't really move the needle on fibromyalgia, we have a very good chance of success moving forward |
| These data are particularly compelling because first, Valacyclovir and Celecoxib in combination with generally very well tolerated |
| And we really think with continued success, we have some very exciting value appreciation for various stockholders |
| We're really excited because moving forward, we're going to test this thesis again |
| As you can see from each one of the rows demonstrated on the table on Page 6, the Valacyclovir-Celecoxib treatment group delivered very statistically significant improvements and a whole host of different disease sequelae |
| This is a very exciting program |
| So, we thought that was a very good outcome because it wasn't two multifactorial studies, but specifically this was one multifactorial plus the head-to-head |
| And if you take a look at the P values for virtually every one of those particular disease sequelae, you see highly statistically and clinically relevant improvement for those patients treated with Valacyclovir-Celecoxib combination versus those matched controls |
| We're particularly encouraged by these data because these patients on average in both the treatment and match control group, had long COVID for a period of two years |
| The first thing I'd like to mention relative to the past quarter is one of our absolutely key achievements, and that is securing FDA guidance and agreement on our plan to progress IMC-1 to Phase 3 development as a potential treatment for patients with fibromyalgia |
| Hopefully, you get a sense that these are very exciting times for Virios Therapeutics |
| So, this is a very significant illness that's responding quite well in this open label exploratory trial |
| We're very excited about this potential opportunity and look forward to those results sometime in the middle of 2024 |
| So, we think that's probably the most efficient way to progress |
| This streamlined approach allows us to maximize the use of our capital for value-creating research |
| We're actively exploring partnership opportunities on three levels, IMC-1 for fibromyalgia, IMC-2 for long COVID, and then any complementary therapeutic interventions to continue to build shareholder value as complements to both IMC-1 and IMC-2 |
| As you can see on Slide 4, the Virios research team has worked diligently over the third quarter to submit the briefing materials to the Food and Drug Administration for our proposed investigation on the drug application, or IND as it's called, for IMC-2 as a treatment for long COVID |
| And that is the primary way we think is the best way, if you will, to move forward |
| This pharmacokinetic and food effects study will be focused on the dose formulation we'll be using to commercialize IMC-1, presuming success in Phase 3 |
| So, a little bit more efficient way to get to potential approval, presuming success clinically |
| Specifically, we're looking at opportunities in the pain and anti-infective space and/or unique opportunities that can create value under various expert research and development leadership as compliments to IMC-1 and IMC-2 |
| What makes this program so exciting? If we can transition to the next slide, to Slide number 5, you'll note that the RECOVER Mechanistic Pathways Task Force has identified activation of secondary viruses as a potential cause for long COVID sequelae |
| 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 |
| It's the most dominant symptom in long COVID |
| In addition, we wanted to make it clear that we're also assessing complementary therapeutic interventions to build Virios shareholder value |
| Patients completing 301 or 302 have the opportunity to roll into this long-term safety extension |
| Greg Duncan Thank you, David, and good morning, and I appreciate you joining |
| What this regulatory requirement is focused on is effectively showing the contribution of both components |
| Thank you |
| Thank you |
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| Finally, we reported a net loss of $1.2 million for the third quarter of 2023, as compared to a net loss of $2.6 million for the year ago quarter |
| There were no serious adverse events in this particular trial, and the most common adverse events in both the Routine Care Group and in the Valacyclovir-Celecoxib group were headaches and muscle pain |
| So, effectively three quarters of all of the disability in this patient cohort is due to long COVID, whereas only a quarter of it was due to the acute infection, highlighting the very significant morbidity associated with this particular illness |
| Obviously, over time, if there's not a lot of separation between IMC-1 and the independent components, I don't think that would be viewed favorably |
| The lower net loss was primarily due to the decreases in R&D and operating costs that I just discussed |
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