Q4 2021 Virios Therapeutics Inc Earnings Call
Thank you for holding, ladies and gentlemen, and please remain on the line. The Vario Therapeutics Conference call will begin shortly. Thank you for your participation.
Thank you for holding ladies and gentlemen, and please remain on the line the various therapeutics conference call will begin shortly thank you for your patience.
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[music].
Good morning, and welcome to Varios Therapeutics, Inc., fourth quarter and year-end 2021 Financial Results Conference Call. At this time, all participants have been placed on a listen-only mode, and the floor will be open for questions and comments after the presentation.
Good morning, and welcome to various Therapeutics, Inc, fourth quarter and year end 2021 financial results conference call. At this time, all participants have been placed on a listen only mode and the floor will be open for questions and comments after the presentation.
Please be advised that today's call is being recorded at the company's request.
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, Senior Vice President of Finance and Treasurer for Varios Therapeutics. Please proceed, Angela.
At this time I'd like to turn the call over to Angela Walsh Senior Vice President of Finance and Treasurer for various 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 various therapeutics, fourth quarter, and year-end 2021 financial results.
Thank you good morning, everyone and thank you for joining us on today's conference call.
We're pleased to be with you today to discuss various therapeutics fourth quarter and year end 2021 financial results as.
Angela Walsh: as well as to provide you with an update on the operational progress we have made during 2021.
As well as to provide you with an update on the operational progress we have made during 2021 .
Angela Walsh: Please note that our financial results press release is now available on our website.
Please note that our financial results press release is now available on our website.
Angela Walsh: We'll start today's call with our CEO , Greg Duncan, providing you with a brief update on our corporate progress here in the past quarter.
Well start todays call with our CEO , Greg Duncan, providing you with a brief update on our corporate progress during the past quarter.
Angela Walsh: and then I will return to review our fourth quarter financial results.
And then I will return to review, our fourth quarter financial results.
Speaker Change: In addition, Ralph Groswald, our Senior Vice President of Operations, is with us for the question and answer portion of the call.
In addition, Ralph Boswell, our senior Vice President of operations.
With us for the question and answer portion of the call.
Speaker Change: 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.
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.
Speaker Change: which involve risks and uncertainties that can cause actual results to differ materially from the information expressed or implied by these forward-looking statements.
Which involve risks and uncertainties that can cause actual results to differ materially from the information expressed or implied by these forward looking statements.
Speaker Change: For more information regarding such risks and uncertainties, please see the risk factors outlined in the company's filings with the SEC.
For more information regarding such risks and uncertainties. Please see the risk factors outlined in the company's filings with the SEC.
Speaker Change: 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.
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.
Speaker Change: Please see the forward-looking statement section in our financial results press release issued this morning for more information.
Please see the forward looking statement section in our financial results press release issued this morning for more information.
Speaker Change: It is now my pleasure to turn the call over to our CEO , Greg Duncan.
It is now my pleasure to turn the call over to our CEO rack Duncan.
Thank you Angela and good morning, everyone.
Greg Duncan: Our team and I are pleased to provide you with an update on the substantial operational progress the Verios Therapeutics team has made over the past few months.
Jim and I are pleased to provide you with an update on our substantial operational progress.
Various therapeutics team has made over the past few months.
Greg Duncan: First off, I'm very pleased to report that under the expert leadership of our chief medical officer, Dr. Mike Genro, our research team continues to recruit patients as planned into our landmark Phase IIb fibromyalgia clinical study, also known as 4PF.
First off I'm very pleased to report that under the expert leadership of our Chief Medical Officer, Dr. My General.
Our research team continues to recruit patients as planned into our landmark.
As to be fibromyalgia clinical study also known as fortress.
Greg Duncan: More specifically, we believe that we are well on pace to recruit over 400 patients into our ongoing FORTRESS Phase IIb study within the next 30 days.
More specifically, we believe that we are well on pace to recruit over 400 patients into our ongoing fortress phase III study within the next 30 days.
Greg Duncan: This will enable us to be fully enrolled in this landmark program by mid-April.
This will enable us to be fully enrolled in this landmark program by mid April .
Greg Duncan: Most importantly, this pace will allow us to remain on track to report top-line results of our Fortress study program by September of this year.
Most importantly, this pace will allow us to remain on track to report top line results of our fortress study program by September of this year.
Greg Duncan: As you may recall, the primary endpoint for this landmark study will focus on the therapeutic effectiveness of our lead development candidate, IMC1, a fixed-dose combination of famciclovir and cellocoxib to reduce systemic fibromyalgia-related pain.
As you May recall the primary endpoint for this landmark study will focus on the therapeutic effectiveness of our lead development candidate <unk>, a fixed dose combination of fan, particularly there and celecoxib to reduce systemic fibromyalgia related pain.
Greg Duncan: IMC1 pain reduction effectiveness will be measured using the same endpoint that was used in our successful Phase 2a fibromyalgia study.
I M C. One pain reduction effectiveness will be measured using the same endpoint that was used in our successful phase II fibromyalgia study.
Greg Duncan: This pain endpoint was also used to approve the three treatments FDA has approved to date to treat patients with fibromyalgia.
This pain end point was also used to approve the three treatments FDA has approved to date to treat patients with fibromyalgia.
Greg Duncan: We will also assess IMC1's effectiveness on a host of other key secondary outcomes measures related to both patient quality of care as well as safety.
We will also assess IMC one's effectiveness on a host of other key secondary outcomes measures related to both patient quality of care as well as safety.
Greg Duncan: In parallel to our FORTRESS Phase IIb study, our chronic toxicology studies in two species are progressing as planned under the direction of our Senior Vice President of Operations, Ralph Grossman.
In parallel to our fortress phase two B study of chronic toxicology studies in two species are progressing as planned under the direction of our senior Vice President of operations Ralph Crosswalk.
Greg Duncan: The results of these studies will be required by regulatory authorities before we are permitted to do study participants with IMC-1 for intervals of one year or more, which we plan to do in our phase three program.
The results of these studies will be required by regulatory authorities before we are committed to dose study participants with IFC one for intervals of one year or more which we plan to do in our phase III program.
Greg Duncan: The Chronic Toxicology Program is timed to complete concurrently with our FORTRESS Phase 2b study, so we anticipate being able to propose a final Phase 3 program to the FDA at the conclusion of the current study.
Chronic toxicology program has time to complete concurrently with our fortress phase <unk> study. So we anticipate being able to propose a final phase III program to the FDA at the conclusion of the current study.
Greg Duncan: Furthermore, we recently announced that we will be progressing our second development candidate IMC2, a combination of valsiclovir and cellococcin, into clinical development.
Furthermore, we recently announced that we will be progressing our second development candidate <unk> two a combination of the cyclic here and celecoxib into clinical development.
Greg Duncan: This exciting new exploratory trial will assess the potential of IMC2 to reduce fatigue and other symptoms associated with long COVID sequelae.
This exciting new exploratory trial will assess the potential of RMC true to reduce fatigue and other symptoms associated with loan Covid sequela.
Greg Duncan: This program is being supported through an unrestricted investigational grant to the Bateman-Horne Center. A non-profit, interdisciplinary organization.
This program is being supported through an unrestricted investigational grant to the beat in the home Center.
Nonprofit interdisciplinary centre of excellence.
Greg Duncan: that is advancing the diagnosis and treatment of chronic fatigue disorders.
Advancing the diagnosis.
Treatment of chronic fatigue disorders.
Greg Duncan: fibromyalgia, post-viral syndromes, and related comorbidities. For context, long COVID.
Fibromyalgia post viral syndrome and related Comorbidities.
For context, one cobot can be very debilitating.
Greg Duncan: and is estimated to affect up to 30% of patients who were previously infected with the COVID virus.
And is estimated to affect up to 30% of patients who were previously infected with the Covid virus.
Greg Duncan: This prevalence rate translates into well over 100 million COVID patients on a global basis and more than 20 million cases right here in the U.S.
This prevalence rate translates into well over 100 million COVID-19 patients on a global basis and more than 20 million cases right here in the U S.
Greg Duncan: To put this in perspective, the U.S. long COVID patient population is estimated to be almost double that of the existing fibromyalgia patient population.
To put this in perspective U S. Small COVID-19 patient population is estimated to be almost double that of the existing fibromyalgia patient population.
Our excitement to support abatement Horn center to progress this new loan Covid program is anchored to several key sentiments.
Greg Duncan: support the Bateman Horn Center to progress this new long COVID program is anchored to several key sentiments.
This new exploratory research program represents an expansion of our combination anti viral pipeline into our second area of significant unmet need.
Greg Duncan: This new exploratory research program represents an expansion of our combination antiviral pipeline into a second area of significant unmet need.
Greg Duncan: Secondarily, this new long COVID-focused program, to the best of our knowledge, represents one of the first long COVID treatment programs in the U.S.
Secondarily this new loan Covid focused program to the best of our knowledge represents one of the first long COVID-19 treatment programs in the U S.
Greg Duncan: We anticipate full enrollment in this exciting new program by quarter four of this year, with results projected in the first half of 2023.
We anticipate full enrollment in this exciting new program by quarter four of this year with results projected in the first half of 'twenty 23 and.
Greg Duncan: And finally, we want to reiterate that through prudent management of cash, that our current cash position is expected to provide the company with operational runway through quarter one of 2023.
And finally, we want to reiterate that through prudent management of cash that our current cash position is expected to provide the company with operational runway through quarter, one of 2023 proxy.
Greg Duncan: approximately six months following the planned announcements of our top line results from our ongoing Fortress phase to be studied.
Approximately six months following the planned announcements of our top line results from our ongoing fortress phase <unk> study.
Greg Duncan: With that update on our operational progress, let me turn it back over to our Senior Vice President of Finance.
With that update on our operational progress, let me turn it back over to our senior Vice President of Finance.
Greg Duncan: Angela Walsh to discuss our quarter four and full year financial results. Angela?
Angela Walsh to discuss our quarter, four and full year financial results.
Thank you Greg.
Angela Walsh: As of December 31, 2021, we had $14 million in cash as compared to $29.8 million as of December 31, 2020.
As of December 31, 2021, we had $14 million in cash as compared to $29 8 million as of December 31st 2020.
Speaker Change: As Greg just mentioned, we expect our current cash to be sufficient to fund the company's operations through the end of the first quarter of 2023.
As Greg just mentioned, we expect our current cash to be sufficient to fund the company's operations through the end of the first quarter of 2023.
Speaker Change: With respect to our income statements, as a development-stage company, we did not generate revenue in 2021 or 2020.
With respect to our income statement as a development stage company, we did not generate revenue in 2021 or 2020.
Speaker Change: We reported research and development expenses of $2.9 million and $10.8 million for the fourth quarter and full year 2021, respectively, as compared to $0.03 million and $0.2 million for the fourth quarter and full year 2020, respectively.
We reported research and development expenses of $2 9 million and $10 8 million for the fourth quarter and full year 2021, respectively, as compared to $2.03 million and point $2 million for the fourth quarter and full year 2012.
<unk> respectively.
Speaker Change: This increase in research and development expenses for the fourth quarter and full year was primarily due to expenses for our FORTRESS clinical study, our chronic toxicology program, and drug development and manufacturing costs.
This increase in research and development expenses for the fourth quarter and full year was primarily due to expenses for a fortress clinical study or chronic toxicology program and drug development and manufacturing costs.
Speaker Change: we reported general and administrative expenses of $1.3 million and $4.8 million for the fourth quarter and four-year 2021, respectively, as compared to $6.4 million and $9.8 million for the fourth quarter and four-year 2020, respectively.
We reported general and administrative expenses of $1 $3 million and $4 $8 million for the fourth quarter and full year 2021, respectively.
As compared to $6 4 million and $9 $8 million for the fourth quarter and full year 2020, respectively.
Speaker Change: This significant decrease in general and administrative expenses for the fourth quarter and full year was primarily due to equity-based compensation expense.
This significant decrease in general and administrative expenses for the fourth quarter and full year was primarily due to equity based compensation expense that was recognized in 2020 for the issuance of membership interests to the company's founder and share based compensation expense.
Speaker Change: that was recognized in 2020 for the issuance of membership interest.
Speaker Change: to the company's founder and share-based compensation expense recognized in 2020 for the issuance of stock options pursuant to executive employment agreements upon our initial public hearing.
<unk> recognized in 2020 for the issuance of stock options pursuant to executive employment agreements upon our initial public offering.
Speaker Change: offset by an increase in costs associated with being a public company.
Set by an increase in costs associated with being a public company.
Speaker Change: We reported a net loss of $4.5 million for the fourth quarter of 2021 compared to a net loss of $6.5 million for the fourth quarter of 2020.
We reported a net loss of $4 $5 million for the fourth quarter of 2021 compared to a net loss of $6 $5 million for the fourth quarter of 2020.
Speaker Change: For the full year 2021, we reported a net loss of $16 million compared to a net loss of $10.3 million for 2020.
For the full year 2021, we reported a net loss of $16 million.
Pair to a net loss of $10.3 million for 2020.
Speaker Change: The higher net loss was primarily due to the higher research and development costs that I just mentioned.
The higher net loss was primarily due to the higher research and development costs that I just mentioned.
Speaker Change: I'll now turn the call back over to Gregg to moderate the question and answer portion of today's call.
I'll now turn the call back over to Greg to moderate the question and answer portion of today's call Greg.
Thank you once again Angela.
Gregg: In closing, we believe the role of activated herpes virus as a potential catalyst in triggering diseases like fibromyalgia, as well as fatigue-related disorders and chronic GI disorders represents an exciting new innovation paradigm.
Closing, we believe the rule of activated herpes virus as a potential catalyst and triggering diseases like fibromyalgia.
As well as fatigue related disorders, and chronic Gi disorders represents an exciting new innovation paradigm.
Gregg: We believe that various combination antiviral development programs are supported by both mechanistic as well as clinical data.
We believe that various combination anti viral development programs are supported by both mechanistic as well as clinical data.
Gregg: The novelty of our approach is further validated by the fast-track designation granted by FDA to IMC-1 for the treatment of fibromyalgia.
<unk> of our approach is further validated by the fast track designation granted by FDA to IFC, one for the treatment of fibromyalgia.
Gregg: which, to the best of our knowledge, represents the first time a new drug candidate has been granted this designation. We expect to reach important milestones
To the best of our knowledge represents the first time, a new drug candidate has been granted this designation.
We expect to reach important milestones in the year ahead.
Gregg: If the forthcoming IMC1 Fibromyalgia Phase IIb data due by September are concordant with the data that emerged from our successful Phase IIa trial, we believe IMC1 could be a true game changer for the millions of patients in the fibromyalgia community. In addition, an encouraging
If the forthcoming IMC warm fibromyalgia face to be data due by September .
Accordingly, with the data that emerged from our successful phase III trial, we believe <unk> could be a true game changer for the millions of patients and the fibromyalgia community.
In addition, and encouragingly.
There is increasing recognition and the scientific community of the potential role of activated viruses triggering the sequela associated with long Covid.
Gregg: in the scientific community of the potential role of activated viruses triggering the sequelae associated with long COVID, which is, in our view, an.
Which is in our view an emerging epidemic of its own.
Gregg: Exploring the potential of our second development candidate, IMC2, to treat long COVID will help us better understand this exciting opportunity. I hope you'll agree. It's shaping up to be an exciting opportunity.
Exploring the potential of our second development candidate <unk> two to treat loan Covid will help us better understand this exciting opportunity.
I hope you'll agree.
It's shaping up to be an exciting year of various therapeutics.
Gregg: As always, we remain committed to frequent and proactive outreach to the investment community, as well as the medical community, as we progress our journey to improve treatment standard for patients around the globe. Operator, we are ready for questions.
Always we remain committed to frequent and proactive outreach to the investment community as well as the medical community as we progress our journey to improve treatment standard for patients around the globe.
Operator, we are ready for questions.
Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please press star one on your phone at this time, we ask that while posing your question you. Please pickup your handset is listening on speaker phone to provide optimum sound quality.
Gregg: If you have any questions or comments, please press star 1 on your phone at this time.
Gregg: We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold.
Please hold while we poll for questions.
Speaker Change: Your first question for today is coming from David Beltz. Please announce your affiliation, then pose your question.
Your first question for today is coming from David bouts. Please announce your affiliation then pose your question.
David Beltz: Hey, this is David Bowden from Zach's Small Cap Research. Good morning, Greg, and thanks for the update this morning. I was wondering if you could provide any more details about the proposed long COVID studies, the number of patients, how long the study is going to be, those type of things.
Hey, this is David Bautz Zacks small cap research.
Good morning, Greg and thanks for the update this morning.
I was wondering if you could provide any more details about the proposed long Covid studies as a number of patients.
How long the study is going to be those type of things.
Sure. Thank you David for joining us this morning.
Greg Duncan: Sure. Thank you, David, for joining us this morning.
We are really excited about this program I think there is increasing recognition of the potential for co infection with these patients is that potential ideology for the loan Covid sequela that are quite debilitating for patients including you.
Speaker Change: I'm really excited about this program. I think there's increasing recognition of the potential for co-infection with these patients. There's a potential etiology for the long COVID sequelae that are quite debilitating for patients.
Speaker Change: including, as you may know, about 30% of those patients who were previously asymptomatic. So we believe this is a.
You may now about 30% of those patients who are previously asymptomatic. So we believe this is.
Speaker Change: a key thing to get right and an emerging epidemic of its own.
A key thing to get right.
And emerging epidemic of its own.
Speaker Change: The program is being run out of the Bateman-Horne Center through an investigational grant. So this is a hands-off program with Dr. Bateman and the Bateman-Horne Center out of Salt Lake City, Utah.
The program is being run out of abatement form center through an investigational grant. So this is a handoff program with Dr.
Statement home center out of Salt Lake City, Utah.
Speaker Change: They are part of a broader program supported by an NIH grant where they're actually monitoring the evolution of patients who are diagnosed with long COVID sequelae.
They are part of a broader program supported by NIH Grant, where they're actually monitoring the evolution of patients who are diagnosed with lung COVID-19 sequela.
Speaker Change: And the goal will be to take somewhere between, call it 25 and 30 patients.
And the goal will be to take somewhere between call. It 25 to 30 patients.
Speaker Change: and begin treatment with IMC2 and compare them to the existing cohort that they're assessing over time.
And begin treatment with IMC, two and compare them to the existing cohort.
Assessing overtime.
Speaker Change: And the trial will run for 14 weeks, thereabouts, and we will assess.
And the trial will run for 2014 weeks thereabouts, and we will assess.
Speaker Change: IMC-2's ability, this is a combination of alciclovir and salicoxib, IMC-2's ability to improve the fatigue, the brain fog, and the other sequelae that are associated with long COVID disease.
<unk> ability. This is a combination of about six <unk> and celecoxib.
<unk> ability to improve the fatigue, the brain fog and the other <unk> that are associated with loan Covid disease.
Speaker Change: This is a classic exploratory trial, Dave, so effectively, we're looking for effects on a number of parameters.
This is a classic exploratory trial, so effectively we're looking for.
Effects on the number of parameters.
Speaker Change: We do recognize that single monotherapy may not be the only way to treat these patients over time, so IMC2 could be part of a cocktail that's used or for a subset of patients. And as a consequence, we'll be assessing all these different parameters as a way to glean more knowledge and then presuming success to progress into what I would describe as a more traditional phase two program.
We do recognize that single model therapy may not be the only way to treat these patients overtime. So IMTT could be part of a cocktail that you.
Or for a subset of patients and as a consequence, there will be assessing all of these different parameters as a way to glean more knowledge and then presuming success to progress into what I would describe as a more traditional phase two program.
Speaker Change: The results from this trial should be available in the first half of next year. We can't get any more precise than that because this is a true hands-off program supported through this investigational grant.
The results from this trial should be available in the first half of next year, we can't get any more precise than that because this is a true handoff program.
Supported through this investigational Bret, but we're excited because we do believe these patients are desperate for therapies and we've already seen IMC won obviously a different combination anti viral therapy, but similar mechanistically IMC one.
Speaker Change: But we're excited because we do believe these patients are desperate for therapies. And we've already seen IMC1, obviously a different combination antiviral therapy, but similar mechanistically. IMC1, which combines famciclovir and cellococcib's ability to improve fatigue.
Which combines them cyclically and celecoxib the ability to improve fatigue.
Speaker Change: related symptoms to increased energy and concentration and other specific.
Related symptoms to increased energy and concentration another.
Specific.
Speaker Change: symptoms in the fibromyalgia community and we're hoping to see those same effects within the long COVID community.
Symptoms in fibromyalgia community and are hoping to see those same effects within the loan Covid community.
Speaker Change: That's the long and the short of it, and hopefully that answers your question, David.
That's the long and the short of it.
Hopefully that answers your question David.
David: uh... yeah thanks and i'm so curious why uh...
Yeah. Thanks.
So I'm curious why.
David: Why the Bateman Horne Center is interested in using IMC-2 as opposed to IMC-1? Are there any specific reasons for that?
Why the debate on home centers interested in using IMC to as opposed to IMC. One is there are there any specific reasons for that.
David: So there is definitely evidence of famciclovir, valciclovir, aciclovir having effects on a whole host of herpesvirus.
So there is definitely evidence of.
There are about six liter acyclic or having effects on a whole host of herpes viruses.
David: Specifically, Valciclavir has probably more published data on the ability to inhibit Epstein-Barr, which we think is a likely bad actor here, or certainly one of the bad actors, and so as a consequence,
Specifically about <unk> has probably more published data on the ability to inhibit Epstein Barr, which we think is the likely bad actor here are certainly one of the bad actors and so as a consequence give.
David: given the request from the center. And I think that, I'm saying I think, we believe their focus on valciclovir is really predicated on that prior established data for valciclovir's effectiveness specifically on Epstein-Barr in the published literature. That was the reason for the request to combine valciclovir with silicoxib. And we're obviously delighted because it allows us to move a second compound forward into development.
Given the request from the center and I think that.
I think we believe their focus on Val <unk> three was really predicated on the prior established data for about cyclical has affected the specific liana Epstein Barr and the published literature that was the reason for the request to combine <unk> with Silicon Nomura.
And we're obviously delighted because it allows us to move a second compound forward into the market.
David: Okay. And then lastly, so the NIH is obviously really interested in figuring out what's going on with long COVID. Do you think there's a pretty good potential for some non-dilutive funding to do additional studies if this one is successful?
Okay, and then lastly, so that the NIH is obviously really interested in figuring out what's going on with long Covid do you think there's a pretty good potential for some non dilutive funding to do additional studies that this one is successful.
Speaker Change: Um, we will certainly explore all sources of funding. NIH traditionally focuses more on epidemiologic studies and things of that nature, but certainly we would explore other venues. Non-dilutive funding is obviously attractive for a whole host of reasons, and that would be one of the things we would look at. But I think, ultimately, if we do show successful results here, we would like to progress this fairly quickly. And so, I think speed is an equally important parameter, if you will, on how we assess progress.
We will certainly explore all sources of funding NIH traditionally focuses more on epidemiologic studies and things of that nature, but certainly we would explore other venues.
<unk> funding is obviously attractive for a whole host of reasons and that will be one of the things we would look at but I think ultimately if we do show successful results here.
Would like to progress this.
Fairly quickly and so I think speeds and equally important.
Parameter if you will on how we assess progressing presuming success.
Speaker Change: Yeah. Okay. Great. Well, thank you for taking the questions this morning. Oh, cool. And.
Yeah, Okay, great well, thank you for taking the questions. This morning.
Of course, and thank you for joining us.
Speaker Change: Your next question is coming from Shawn Lee. Please announce your affiliation, then pose your question.
Your next question is coming from Sean Lee. Please announce your affiliation then pose your question.
Shawn Lee: Good morning, Greg. This is Sean Lee from HC Wainwright, and thanks for taking my question.
Good morning, Greg This Sean Lee from H C Wainwright and thanks for taking my questions.
Sean Lee: So I just have a couple of questions on the FM program.
So I just have a couple of questions on the.
<unk> program.
Sean Lee: assuming the readout goes well later this year and as well as the long-term safety study. So do you have any idea what the potential phase three will look like at this time? Yeah, good.
Assuming the readout goes well later this year and as well as the long term safety study. So do you have any idea what the potential phase III will look like at this time.
Yeah, Good morning, Sean and thank you for joining.
Sean Lee: So we're about six months away from what we would consider a pretty landmark result for these patients. I think you're quite well aware, Sean, of the dissatisfaction in the market, both amongst the patients, as well as, frankly, the prescribers, as well as payers, given these patients cycle through their healthcare systems on a regular basis.
So we're about six months away from what we would consider a pretty landmark result for these patients and I think you are quite well aware shot of the dissatisfaction in the market both amongst the patients as well as frankly, the prescribers as well as payers given these patients cycle through the health care systems on a regular basis.
Sean Lee: rack up costs pretty substantially. So presuming good results in September .
Backup cost pretty substantially so presuming good results in September .
Sean Lee: The goal would be to get down to FDA in quarter four of this year and scope out what exactly the phase three program looks like.
The goal would be to get down to FDA in quarter four of this year and scope out what exactly the phase III program looks like.
Speaker Change: As Angela had referenced, we have cash to get us through quarter one.
As Angela had referenced we have cash to get us through quarter. One 2023. So we have time to figure out exactly what the phase III program will entail.
Speaker Change: 2023, so we have time to figure out exactly what the Phase 3 program will entail. We will make the case, albeit we could never guarantee this, Sean, that this particular trial that we're unblinding in September
We will make the case, albeit we could never guarantee to show them that this particular trial that were unblinded in September .
Speaker Change: has really been designed in concordance with many of the requirements of a phase three. The size of the trial, the end point, the duration of the trial.
Really been designed in concordance with many of the requirements of the phase III the size of the trial the endpoints the duration of the trial.
Speaker Change: All are consistent if you look back through the NDAs for the three approved drugs with the size, scope, endpoints, et cetera. So we frankly designed this program to potentially be part of our registration package.
All are consistent if you look back through the the NDA for the three approved drugs with the size scope endpoints et cetera. So we.
Frankly designed this program to potentially be part of a registration package and so while I can't tell you whether it's one or two studies, we will certainly make the case that only one study is required to move forward from a clinical perspective, obviously subject to FDA.
Speaker Change: And so, while I can't tell you whether it's one or two studies, we will certainly make the case that only one study is required to move forward from a clinical perspective, obviously subject to FDA alignment.
Alignment, we do believe given this is a combination therapy that the remaining trial or potentially the remaining trials would include a multi factorial trial.
Speaker Change: We do believe, given this is a combination therapy, that the remaining trial, or potentially the remaining trials, would include a multi-factorial trial.
Speaker Change: where we'll assess IMC1 versus stand-alone salicoxib, stand-alone famciclidone and placebo.
Where we will assess IMC, one versus Standalone, celecoxib, Standalone, FEMSA caldera and placebo.
Speaker Change: And the goal here will be, again, to show statistical significance.
And the goal here will be again to show statistical significance.
Speaker Change: of IFC1 versus placebo, and as part of the multifactorial trial, characterize, if you will, the relative contribution of the two independent components.
The IFC, one versus placebo and as part of the multi factorial trial characterize if you will the relative contribution of the two independent components.
Speaker Change: Just kind of fast-forwarding to our thoughts on that likely requirement, this doesn't scare us. As you probably are well aware, NSAIDs and COX-2 inhibitors have been studied independently to treat fibromyalgia and failed. There's a Cochrane review which is actually published on a website that shows that.
Just kind of fast forwarding to our thoughts on that likely requirement. This doesn't scare us as you probably are well aware nsaids and Cox two inhibitors have been studied independently to treat fibromyalgia and fail. The Cochrane review, which is actually published on our website that shows that.
Speaker Change: And antiviral therapy as monotherapy has been studied in fibromyalgia and not performed well. It's only when you put these two things together in our opinion that you get the profound results that we saw in the phase 2a and hope to see in a phase 2b trial. So we're not worried about doing that trial and frankly are hoping to do only one trial as part of the phase 3, but ultimately the data from this trial
Anti viral therapy as monotherapy has been studied in fiber miles and not performed well.
It's only when you put these two things together in our opinion that you get the profound results that we saw in the phase Iia and hope to see in the phase two b trial. So.
We're not worried about doing that trial.
And frankly, you are hoping to do only one trial was part of the phase III, but ultimately the data from this trial.
Speaker Change: and the FDA's feedback will determine that. And then we can decide, you know, what capital we want to raise, do we want to bring in a partner and explore the best path forward for various and shareholders.
And the Fda's feedback will determine that and then we can decide what capital we want to raise do we want to bring in a partner and explore the best path forward for our various and shareholders.
Speaker Change: Thanks, Greg. That was very helpful. And my second question is also on the potential for another study. So before we have to do that, are there any CMC issues that you have to take care of before you can launch a phase three?
Thanks, Greg Thanks that was very helpful.
My second question is also on the potential for another study. So before you have to do that are there any CMC issues that you have to take care of if we can launch a phase III.
Speaker Change: So, we are quite comfortable in the process that we use to manufacture IMC-1, and obviously, we're also manufacturing placebo right now, at present, for the Phase 2b trial.
So.
We are quite comfortable on the process that we use to manufacturer I M. C. One and obviously, we're also manufacturing placebo right now at present.
The phase two B trial.
Speaker Change: The process we are thinking about scoping out and putting a little bit more scholarship into would relate to manufacturing the independent components of filocoxib and famciclovir in that multifactorial scenario. So we're kind of thinking through that at present and could we want to be prepared. And I think as you probably well know, Sean, given you focus on many companies.
The process, we are thinking about scoping out.
Putting a little bit more scholarship into would relate to manufacturing the independent components of Celecoxib and FEMSA Comercio multifactorial scenario.
So we're kind of thinking through that at present and could we want to be prepared.
I think as you probably well know Shaun giving you you focus on many companies.
Speaker Change: Getting ahead of any potential supply related issues is always a good thing. We don't forecast any supply issues, haven't experienced any.
Getting ahead of any potential supply related issues. There's always a good thing we don't forecast any supply issues haven't experience study and frankly, the API for the components here is pretty readily available for multiple markets, but we might consider.
Speaker Change: And frankly, the API for the components here is pretty readily available for multiple markets. But we might consider starting on that process and getting that squared away so that there's absolutely no delay between agreement with FDA and actually executing the Phase III program. So those are the thought processes we're considering. And Ralph Gruswald, in particular, is working through that process.
Starting on that process and getting that squared away. So that there is absolutely no delay between agreement with FDA and actually executing the phase III program. So those are the thought process, we're considering and Ralph Roswell in particular as I was walking through that process.
We will be ready to go.
Speaker Change: we'll be ready to go as soon as possible for the phase three once we get that plan sorted. That's our goal.
As soon as possible for the phase III once they get that plane shortage.
That's our goal.
Speaker Change: Good to hear. Thanks again for taking my questions. Of course. Thank you for joining, Sean.
Good to hear thanks, again for taking my questions.
Course, thank you for joining John .
Speaker Change: Once again, if there are any remaining questions or comments, please press star 1 on your phone at this time.
Once again, if there are any remaining questions or comments. Please press star one on your phone at this time.
Speaker Change: There are no further questions in queue. I would like to turn the floor back over to Greg for any closing comments.
There are no further questions in queue I would like to turn the floor back over to Greg for any closing comments.
Greg Duncan: Thank you, Holly. I appreciate it. And thank you all for joining this morning, be it on the webcast or on the actual line here. Hopefully, you can see that this was a pretty exciting time for Rio Therapeutics. We're pursuing two very significant commercial opportunities. One is in the established, but frankly, dissatisfied fibromyalgia patient community. The other is in what we believe is an emerging epidemic of its own, that being the lung COVID sequelae that are quite debilitating to patients, including those that were previously asymptomatic.
Thank you Holly I appreciate it and thank you all for joining this morning be it on the webcast or on the on the actual line here hopefully you can see that this was a pretty exciting time for various therapeutic we're pursuing two very significant commercial opportunities. One is in the established but frankly dissatisfied fibromyalgia patient community. The other is in what we believe is in there.
Emerging epidemic of its own that being my lungs COVID-19 .
Covid sequela that are quite debilitating patients, including those that were previously a symptomatic.
Greg Duncan: We are pretty excited about our approach, and I think the external scientific community is increasingly recognizing the role of activated herpes viruses as a potential trigger for many chronic diseases.
We are pretty excited about our approach and I think the external scientific community is increasingly recognizing the role of activated herpes viruses as a potential trigger for many chronic diseases and is evidence of the novelty of that approach.
Greg Duncan: And as evidence of the novelty of that approach, we have a fast-track review designation granted by FDA for our lead compound, IMC1, to treat fibromyalgia. So we're pretty excited that the external world is now both recognizing this potential mechanism and recognition exists with regulators as well. We have excellent IP into 2033, and we've got a team that's really got great development and commercialization experience, including having had actual hands-on leadership role
We have a fast track review designation granted by FDA for our lead compound items. He one to three.
Fibromyalgia, so we're pretty excited that the external world about both recognizing this potential mechanism and a recognition exists with our regulators as well we have excellent IP into 'twenty 33, and we've got a team that's really got great development and commercialization experience.
Coding having had actual hands on leadership roles.
Greg Duncan: in developing and commercializing two of the previously approved drugs from FDA here in the U.S. to treat fibromyalgia. And I want to thank the team specifically. As those of you who follow the biotech industry know, many companies have consistently guided based on slower enrollments, problems getting drug supply, etc.
In developing and commercializing two of.
The previously.
Proved drugs from FDA here in the U S to treat cargo milder and I want to thank the team specifically as those of you who follow the biotech industry know many companies have consistently we guided based on slower enrollment problems getting drug supply et cetera.
Greg Duncan: And Mike and Ralph have done a superb job on the research side, Ralph on the supply side, and Angela in managing our cash.
Mike and Ralph have done a superb job on the research side, Ralph on the supply side, and Angela and managing our cash such that we have continued to reiterate our guidance that we have cash through quarter. One of 2023, which is a full six months.
Greg Duncan: such that we have continued to reiterate our guidance that we have cashed through quarter one of 2023, which is a full six months.
Greg Duncan: beyond the data readout we're projecting for our Landmark Tribal Knowledge Program. So, stay tuned.
Beyond the data readout, we're projecting for our landmark <unk> program, so stay tuned.
Greg Duncan: We're about six months away from hopefully changing the world from hundreds, or hundreds of millions of fibromyalgia patients worldwide.
We're about six months away from hopefully changing the world from hundreds for hundreds of millions of fibromyalgia patients worldwide.
Greg Duncan: and then would look to see the effects of IMC2 in the long COVID patient community roughly.
And then we'd look to see the effects of IMC too and the loan Covid patient community.
<unk> six.
Greg Duncan: six months after that, plus or minus. So thank you for your time and attention. Stay tuned and we look forward to connecting with you for our quarter one results in about two months. Thank you and goodbye.
Six months after that plus or minus so thank you for your time attention stay tuned and we look forward to connecting with you for our quarter. One results in about two months, Thank you and goodbye.
Speaker Change: Thank you ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.
Thank you ladies and gentlemen, this does conclude today's conference call. You may disconnect. Your phone lines at this time and have a wonderful day. Thank you for your participation.