Q4 2023 Atea Pharmaceuticals Inc Earnings Call
Yeah.
Good afternoon, everyone and welcome to the RTI Pharmaceuticals fourth quarter 2023 financial results and business update conference call. At this time all participants are in a listen only mode. Following the formal remarks, we will open the call up for your questions I would now like to turn the call over to Joe.
Barnes Senior Vice President of Investor Relations, and corporate Communications and I tear pharmaceuticals, that's borne please proceed.
Good afternoon, everyone and welcome to what Teva Pharmaceuticals fourth quarter and full year 2023 financial results and business update conference call earlier today, we issued a press release, which outlines the topics. We plan to discuss you can access the press release as well as the slides that we'll be reviewing today by going to the investors section of.
Our web site at IR Dot a tiger pharma Dot com with me today from a town or a chief Executive Officer and founder Dr. John Here some of them see Dr. Rancho Haruka, Chief Medical Officer, Chief Development Officer, Dr. Janet Hammond.
<unk> financial Officer, and executive Vice President of legal and Dirty of Cortland, and our Chief commercial officer, John separate that they will all be available for the Q&A portion of today's call before we begin the call and as outlined on slide two I would like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties. These risks.
And uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read our actual results may differ materially from what is discussed on today's call.
With that I'll now turn the call over to Sean here.
Thank you John and.
Good afternoon, everyone and thank you for joining us.
I'll begin on slide three.
Looking back at our substantial progress throughout 2020.
I'm proud of the strong operational execution, we achieve across so antiviral programs. The 2023 highlights from our COVID-19 program include the ability to leverage global soldiers to meaningfully advance our phase III Sunrise III study.
This was made possible by the expansion of the global footprint and the broadening of the eligibility criteria for high risk patients. So far in 2024, we continue to observe encouraging enrollment trends for sunrise.
Reflecting the continuing unmet medical need we were granted fast track designation by the FDA for the year.
Emulation of any positive vehicle COVID-19.
We are continuing to demonstrate but any possible via remain fully active against all variance tested in vitro, including $10 million variance related to the micro.
The profile for <unk> is supported by robust clinical data, including favorable efficacy and safety with no drug drug interaction.
We believe that many folks Vivian has the potential to address the key limitations.
And COVID-19, all therapies.
HCV.
23 of highlights include achieving regulatory approvals for short eight week treatment for the global Phase II trial of the combination of any fossil <unk> and <unk> for the treatment of HCV.
The rapid enrollment.
They didn't call, which has led to exciting as we are results that we where do we view today.
We demonstrated in vitro synergy of the combination of any possibly on the residence Vail and the compelling potency profile against major HCV and resistance mutations.
We are now evaluating several fixed dose combination tablets and preparation for the phase III program and subsequent commercialization.
And we presented and published correct clinical and clinical data in support of this program.
We believe many funds we've been combination with Cigna.
Significantly improve upon the current standard of care by offering differentiated short eight weeks protease inhibitor free treatment, which has been well tolerated and has limited potential for drug drug interactions.
Moving to slide four.
At their vision is focused on the discovery and development of antiviral drugs for the treatment in Q, a serious trial diseases, where there is a significant unmet medical need and where we can make a huge difference.
As you know we believe that.
Cabot has to step.
And the recent who enter search reminds us.
The new dominant on variance like Jan.
Striving, despite the lasers vaccine booster and treatments.
The SaaS <unk> accumulating mutations.
I mean no acid substitution.
Yes.
Then any other endemic RNA Ross highlighting the desperate need for a broader and more diversified arsenal of safe.
Well tolerated and easy to prescribe.
All anti <unk> therapy.
Our team continues to efficiently execute our global phase III trial, and I am very pleased to announce today that we have achieved another significant clinical milestone and surpass enrollment of 40 and 100 patients.
<unk>, our second interim analysis in the supportive care monotherapy cohort.
This is an important milestone.
Allowing for the data review by the independent the SMB from safety and futility.
For Sunrise Xray, we anticipate several upcoming events.
<unk> the first interim analysis in March.
Secondly, chairman analysis in the second quarter of 2024.
And topline results during the second half of 2024.
Any thoughts would be has the potential to address many of the key limitations of.
COVID-19 therapies, including safety.
Reliability and drug drug interactions.
ROE is.
Is to deliver best in class treatment for the millions of patients for willing to current standard of care is suboptimal or unsuitable.
As part of a multi pronged approach against COVID-19, we.
We continue to also make progress with that.
Our discovery program focused on our highly differentiated second generation protease inhibitor and we expect to provide an update midyear.
For our phase II HCV program as stated earlier.
We share the results with confirm at 98% as we are for <unk>.
Post treatment in the leading cohort of our phase II combination eight weeks.
<unk> will review these results in more details.
Our goal for this program is to substantially enhance the current set of care by offering a short.
A two week tour.
<unk> inhibitor free treatment that is well tolerated with lower potential risk or drug drug interaction for all HCV patients.
Importantly, we are in a strong financial position to execute our strategy with $578 $1 million of cash and cash equivalents as of December 31, with a runway anticipated through 2026.
Andrea will provide a detailed update on our financial position during today's call.
I would now.
Turning the call over to ramp up for an update on our HCV program.
Thank you Cynthia.
Turning to slide six.
By current treatment option HCV continues to be a health crisis in the U S.
As Jim noted earlier.
Similarly, $2 4 million people infected with HCV in the U S. Despite availability of oral treatments.
Recent trends indicate that more new infections and lean question Dan Yes.
Early days.
These statistics highlight the need to improve the HCV treatment landscape.
The company then you call Sylvia angle Cynthia has the potential to substantially improve upon the current standard of care by offering a short eight with protease inhibitor free treatment with less side effects and the low risk <unk>.
Drug interactions.
Based on our market research with Kols and high prescribers. These attributes are very critical for a new treatment.
On the next slide.
Moving to slide seven welding.
While the introduction of direct acting Antivirals Hudson's form HCV treatment significant unmet need still exists.
In recent quantitative market research conducted by appear with over 150 <unk> decision.
Hi, Chris Kreidler, albeit closer automobile.
The 6%.
Patients reported that they are non needs regarding HCV treatment.
Kim that need American in this research with shorter length of treatment.
As you can see particularly in HIV co infected patients as well as fewer contra indications are detailed on the right hand of the slide.
Please note that currently approximately.
17% of patients do not complete their treatment regimen, knickman convenient and shorter treatment duration of particular importance to prescribers.
Slide eight outlines our phase two open label study of 550 milligrams of <unk> plus <unk> in combination with 180 milligrams of <unk> once daily for eight weeks, we plan to enroll up to 280 DAA nave patients across all genotypes.
In the initial cohort sustained biological response at.
At week four was used as the decision criteria to reinitiate enrollment to complete the phase II study.
Primary endpoint of the study.
At week.
12.
This will be reported for all patients on study completion.
Slide nine highlights the patient demographics and baseline characteristics in the leading cohort of the phase II open label study of <unk>.
Patients with <unk> naive some medium age of 47 years old.
This cohort was comprised of non cirrhotic patients only Howard.
Please note that 10 patients had fibrosis stage III on what advanced liver disease stage, which is borderline with cirrhosis in the second part of the Phase III study.
Serologic patients will also be involved.
Moving to slide 10, we are excited to share with you today.
Final results from the Phase two combination study in the leading cohort confirmed on SBS four of 98% post treatment across all genotypes.
In January we initiated enrollment to complete this study in up to 280 patients with top line results anticipated in the second half of 2024.
Seven shows the on treatment viral kinetics of individual patient data.
Weak for all 60 patients in this cohort have viral load.
Near or below the lower limit of quantification. Therefore, this very rapid kinetics across all genotypes supported eight week regimen and compare favorably.
She is the only approved eight week treatment for HCV.
On slide 12, the combination of <unk> <unk> was generally safe and well tolerated in this cohort of 60 patients.
No drug related serious adverse events, no discontinuation and adverse events were mostly mild.
Turning to slide 13 to summarize our progress in HCV based on the positive leading cohort data we initiated enrollment in January for the remainder of the phase two trial.
Advanced <unk> Goldman Chief Representative genotype distributions, we are increasing this study's footprint to approximately 50 clinical sites in 15 countries.
In addition, we will go to the first half of 2024, we are conducting phase one studies in the U S for the selection of the <unk>.
Fixed dose combination tablet, which will be evaluated in the phase III program and used for subsequent commercialization.
We anticipate that the phase III program will be initiated around the end of this year.
Slide 14.
We will provide an update on our COVID-19 program I will turn the call over to Janet to discuss our son Rice III phase III trial.
Thanks, Sarah and good health.
Afternoon, everyone.
COVID-19 continues to be an established pathogen is concerned according to the World Health organization.
We believe that COVID-19 will remain an ongoing curious endemic issue.
Argo for COVID-19 is to deliver a safe and effective treatment for millions of patients within the current standard of care is not a surgical option.
We believe that the compelling preclinical and clinical profile up any cost of gas is differentiated with a low risk with drug drug interactions.
Favorable tolerability.
A high barrier to resistance.
It has the potential to become the treatment of choice for COVID-19 for millions of patients.
Moving to slide 16.
Supported by our extensive global footprint, we are seeing robust enrollment into sunrise III and patient enrollment is current with the latest win two ways.
In particular, we've experienced strong enrollment in the U S where sites are being responsible for approximately 75% of the patients enrolled to date.
The majority of patients globally continues to be enrolled in the monotherapy cohort. Despite the availability of other oral anti bot.
With like to share with you today. The contractor is the past enrollment to 1400 patients in the monotherapy cohort triggering.
Triggering the second interim analysis.
The deal can be is expected to meet in March for the first interim analysis and we expect the second interim analysis to occur during the second quarter.
Just to remind you the DSM be reviews are primarily geared towards safety and futility.
So far this winter.
<unk> by the U S. CDC respiratory diseases are showing similar high trend to last year.
The patients must vulnerable to severe COVID-19 infection remain the elderly the immuno compromised and those with underlying risk factor to severe infection oral therapeutics are of critical importance to protect against hospitalization and complications.
Turning to slide 17, I will now go into detail on our Sunrise three global Phase III trial.
Our inclusion criteria focused on high risk patients with mild or moderate COVID-19, regardless of vaccination.
On pages, five or less days before randomization.
The phase III study is randomized double blind and placebo controlled study.
The study drug is if any cost of 550 milligrams PID or placebo is administered concurrently with the liberty available standards of care.
There are two study population depending on the type of standard of care received.
The supportive care monotherapy cohort comprises the primary analysis population.
The combination cohorts as part of the secondary analysis and includes patients treated with local standards of cat, including other compatible COVID-19 antiviral drugs.
The primary endpoints of the study is all cause hospitalization or death through day 29, and the supportive care monotherapy population.
Which will be approximately 2200 patients.
The secondary endpoints are COVID-19 related hospitalizations and deaths.
Medically attended visits.
Simpson rehab.
Last year, we were granted fast track designation for <unk>, reflecting the recognized unmet medical need that remain for COVID-19 patients.
Overall, we're seeing strong operational execution to Sunrise III from our clinical team with robust enrollment trend.
I am now going to hand, the call is John to discuss the market marketing opportunities for Benny Fox again John.
Thank you Shannon.
Turning to slide 19, we know that the U S prescription demand for oral antivirals to treat COVID-19.
Correlates with the infection rates the demand for oral Antivirals in 2023 was very robust with a total of approximately $7 7 million scripts written last month. The scripts were approximately 920000, which reflects the latest winter surge.
On the next slide Slide 20 late.
Late last year the market for COVID-19, oral anti Virals began transitioning to traditional payer markets, such as Medicare Medicaid and private commercial insurers.
Oral antivirals therapeutics for COVID-19 are expected to remain a multibillion dollar opportunity for years to come.
Projected annual COVID-19 oriented viral use demand using IQ via retail prescriptions.
The estimated annual global market opportunity of over $4 billion to $5 billion.
With only two products that each have key limitations.
We believe there is still an unmet need with critical gaps.
There is the opportunity to expand this market to patients due to drug drug interactions and Tolerability with tax love It and safety issues with the caveat.
I'll now turn the call over to Andre to discuss the financials.
Thank you John SG&A mentioned earlier. This afternoon, we issued a press release containing our financial results for the fourth quarter and full year 2023 statements.
Statement of operations and balance sheet are on slides 22, and 'twenty three.
There was an increase in R&D expense for the fourth quarter and full year 2023.
The corresponding periods in 2022.
The primary driver for the higher.
With the extra will expand.
Related to our COVID-19 phase III Sunrise.
<unk> clinical trial, and our phase II clinical trial of the combination of any thoughts there in beer to the treatment of hepatitis C.
General and administrative expenses remained relatively flat for the fourth quarter and full year versus the corresponding period in 2022.
Interest income increased for the fourth quarter and full year 2023 versus the corresponding period. In 2022. This was the result of investing in higher yield marketable securities and higher interest rates.
At the end of the fourth quarter of 2023 for cash cash equivalent and marketable securities balance is from Pierre mentioned with $578 $1 million.
Based on our current plans.
Reiterating our cash guidance with a runway through 2020.
I'll now turn the call back over to Sean here for closing remarks.
Thank you Andrea and closing.
Following a year of solid operational execution across our two clinical program.
Our clinical momentum sets us up for a transformational milestone rich 2024 for both our private and 19 in HCV program.
For COVID-19.
We anticipate meaningful clinical milestones beginning in the first quarter of 2024 was the first interim analysis from our global Phase III trial.
Followed by a second interim analysis in the second quarter of 2024.
Top line results.
As expected in the second half of 2024.
For HCV, we anticipate completing enrollment of our phase II study.
And reporting results.
During the second half.
2024.
We are continuing to target the initiation of a phase III around at the end of the year and we are extremely encouraged by the SVR for safety results in the leading cohort.
We are targeting multibillion dollar markets.
Each of which.
Currently comprised of only two primary products.
We believe that our product candidates are very differentiated and have the opportunity.
Proved to fill the gap in the current unmet medical needs and become broad Buster product.
We are very excited about the opportunities ahead.
Im confident.
Ability to develop and commercialize innovative products and create meaningful shareholder value.
In particular.
Very proud of the team hard work throughout the year.
<unk> is a company with less than 80 employees.
Which is conducting two global studies in disease with a multibillion dollar market opportunities with a high degree of proficiency.
As well as with significant financial discipline.
With that I will turn the call back over to the operator.
Certainly as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again and one moment for your first question.
And our first question will come from Eric Joseph of Jpmorgan. Your line is open Eric.
Thank you.
For taking the questions a couple from us.
Just on the.
Yes.
Sizable.
Accrual in patients for Sunrise III do you have visibility.
In terms of.
I guess, how those are apportioned across the different study arms monotherapy versus combo.
What visibility do you have in terms of percent to enrollment completion of the monotherapy primary analysis population.
And on the HCV side, just picking up on a comment you made.
JP about potentially being a non <unk>.
Protease based inhibitor option.
What's the significance of that is there a sort of a safety advantage that you'd highlight or is it more about just being an alternative mechanism compared to the other commercially available week regimen.
Got it. Thank you Eric there is definitely an important thing that differentiation, but let's start with the recovering 19 questions.
Great question, Jamie do you want to give a little bit some granularity.
Hi, Eric.
Sure. Thank you for the question Chris in regard to how the patients are a portion to the combination versus monotherapy.
First of all just to say that this is at the discretion of the investigators and prescribers, who sees the patients and they are encouraged to prescribe combination therapy.
If they believe that is.
For the patients and lastly, educators quite extensively at all.
Investigation results in that regard.
And I think it's quite surprising is that the vast majority of patients.
Actually being assigned to the monotherapy arm.
And I think for this probably.
And really the potential extent the potential for drug interactions.
First David with return of that in the <unk> combination treatment, which I think.
Deter people from prescribing combination therapy to patients and then in regards to your question around when we if we have any visibility as to when we might complete accrual in the monotherapy arm.
Weekend, but I can't say that enrollment is proceeding well but of course, we're very dependent on the fluctuations, including cases, we've seen a very strong winter season, but.
Frequency I think at least in the past we observe that that's followed by.
Some downward trend in the number of cases until we get towards the hot summer months when people moving towards again.
So we're somewhat dependent on that so we'll have to see.
Thank you.
So related to the HCV questions.
With the.
Uh huh.
The survey from a third party.
Really exemplify the importance.
For lack of protease inhibitors in the combination treatment.
Especially when we are talking about about 40% of <unk>.
Ivy infected patients with HCV.
Yogurt drove substantial drug drug interaction they free up if you ever put <unk>. So it is an important differentiation John you want to.
Maybe.
Also expand on that.
And really this is not just a gimmick here that we are talking but ready importance from a commercial standpoint, and then I will ask Scott.
I ran so from a patient standpoint, John do you want to.
Address that from a commercial standpoint.
Sure So Eric from a commercial standpoint, obviously being protease III is really important to us for the logo drunk DDI interactions potential.
And also it.
There is also other advantages such as having no food effect and also to be able to treat with a shorter treatment duration, particularly important because as Roger mentioned earlier in the presentation.
What clinicians are finding is that the shorter time to treat is the better and to highlight this about.
It has obviously a protease inhibitor and when you look at the new Rx market shares even despite being eight weeks versus 12.
There is.
There is almost a little bit more than a 10 point share difference in favor of a closer and so that should maybe also tell us some things as well.
So from a patient point of Toyota.
Our discussion with Kols and prescribe it go ahead.
Yes, so medical perspective, I think what we're trying to develop here is really a best in class regimen that combines the best of it.
<unk> on the best of Margaret in the sense that.
It's an eight week regimen.
And we felt the drug drug interactions.
I'm actually quite common.
Margaret and thought they seem to be have a surplus in this outcome on drugs, we're talking about things like contraceptive onto <unk> therapy stop beams.
Pumping, maybe does which you know almost everybody on the phone based on something like that.
So this is this is very important for the patients as the market, which research has indicated but also when we talk to the kols on the field on when they were actually trying to redo our protocol and participate in our clinical trial all of them were very excited that we could actually develop these best in class regimen, bringing.
The best.
Both attributes of both regimens.
Thanks, Joe I'll wrap up.
And one moment for our next question.
And our next question will be coming from Maxwell score of Morgan Stanley. Your line is open Maxwell.
Great. Thank you for taking my questions given your strong financial position I was hoping you can elaborate a bit on your capital allocation strategy and how you are preparing for potential launch in COVID-19.
Dancing your global HCV program basically how should we think about spend over the next several quarters. Thank you.
Andre if you want to address that question maybe just.
I'd like to.
Two two.
Indicate that.
For the launch.
An important and meaningful difference and and of course hospitalization and death, all the worst outcomes and say if one can prevent those and and reduce the severity of disease I think that's going to be really important.
Thank you Jason.
Jason.
Go ahead, John Sorry go ahead, no I was just going to ask you. If you wanted to follow on with Jets because other question around the.
Scenario, while we fail to achieve a primary endpoint.
Yes go ahead.
[noise] Vacates there I think I mean, certainly I mean, it's it's one of those things that is under consideration is is if we're unable to do that all that all that sort of avenues to pursue in terms of looking for trends and we.
We have a fast track designation with FDA.
To assess how to proceed.
But we also have as I think has been mentioned two interim analyses I'm glad that the SNB will help us to make the decision not to proceed should we.
Steve.
Number of patients in roughly are projecting would allow us to be successful. So I think those are the scenarios that we're certainly aware of and thinking about that.
But at the moment and things are moving forward well and we look forward to presenting results unless you to updates as we move forward.
Thank you Jonathan just for that I wanted to add to the first question is on <unk>.
It's very telling that the NIH actually recently reported that only 15%.
High risk actually thinking about it's robin.
And actually so 85% of <unk> should guests.
Yes.
Dr. Paul.
Very likely many of the reason of the limitation of back solve it. So you can see that.
As a huge opportunity for us.
Our best in class product.
Including even with the challenging the challenges that we face as Jonathan and Jessica you recognized in term of.
Number for LOE event, but we believe that.
This study has been built.
We'll maximize the results.
The efficacy and safety of this drug.
I understand you may I have another question on HCV Israel.
Yes. Thank you so on the Hep C program, given the context that compliance with existing therapies.
Lacking with existing regimen. So there is an unmet need here and the patients you're presumably going after are the ones that we know already arent better compliance or else. They would be cured already how do you guys plan to ensure for the phase III that the protocol in clinical sites can optimize good drug adherence, especially since.
We've already seen that one patient in phase III part here with us unable to achieve SVR for.
That's a great question Jessica.
So we spent quite some time.
That said I would like to address the question.
Yes. It is a great question I think in part.
The compliance issues are just part of the nature of doing trials.
Hepatitis C.
The population that we have that is in high unmet need right now is a bit of a mix of the patients who are.
Taking drugs.
And they are just general patients, but also their survey.
A large population of patients.
Ex IV drug users or IV drug users.
Those really benefit from short treatment durations.
So I think by offering a shorter treatment duration you'd already addressed in some of the compliance issues.
Because patients in general are very excited to take dress at the beginning but then.
Sometimes they forget towards the end of the treatment I think we have all experienced that.
With duration already held.
We of course have the regular measurements of.
Sticking with the patients calling them bringing them in.
Very important in phase III is that we're going to have a comparator. So the issues with compliance will affect.
Both arms equally because the patients are randomized and there youre really going to see.
How the comparator is behaving in today's kind of population.
<unk>, which includes these patients.
Noncompliant in general.
Obviously.
Sure.
It will be.
Finalize any protocol with the regulatory authorities, so but but.
Based on our initial interaction is key.
Clear that.
Alright.
<unk> is required.
For our phase III program.
Thank you very much.
And one moment for our next question.
Okay.
And our next question will be coming from Orlando Ruiz of Leerink partners. Your line is open.
Thank you. This is Rosa Chen on for honorees Leerink partners, just a couple from US first on Covid, So thinking of all the various high risk patients you're enrolling in sunlight three which the population do you think that would be cause severe can offer the most differentiated profile.
From currently available Antivirals and any thoughts on how you could leverage that data from the combination therapy arm.
Joe you'd like to address the question. Please.
Sure.
I think with regard to the high risk patient population.
It's quite interesting but I.
I think in the in the last few months have been a couple of publications Randy sharing that.
Most high reputation.
Elderly, particularly I think there's 75 and above.
And those that are highly immunocompromised and I think in Africa, particularly solid organ transplant patients.
However, many times they get vaccinated it doesn't really seem to reduce the risk of getting really ill when they do.
To become infected with Covid. So I think these are the patient populations, which are probably the ones.
There is likely to be the greatest benefit and I think another reason.
Ultimately I think Bethany caster, there would be an ideal drug for patients such as neat is that these are patient populations that are on multiple concomitant medications and as John mentioned and as we've alluded to I think the potential for drug interactions, particularly with protease inhibitors is much higher.
Then with nucleoside antagonist and so I think these are the patient populations.
Frequently that actually is eligible to receive a drug such as touch service.
And have been in the past.
Fortunate enough to have been able to receive monoclonal antibody, but as you know I'm. The monoclonal antibodies haven't been able to keep pace with the evolution of the virus.
And then.
With regard to the the.
Nation group and what triggered that too.
Educate ourselves.
It's Randy.
Most important I think.
Because we have.
Pam mentioned in his remarks, a protease inhibitor, which is.
Being developed and which we hope to share more information and links from the yeah, and so I think I'm being able to see how combination therapy and in particular appreciates and has it had in combination then you have to that is able to and provide synergy and potentially reduce various symptoms and allow patients to improve better.
And also we're essentially looking at such things as Dr. Contractions, followed kinetics on safety and Tolerability I think all of that information is important in understanding how best to use these drugs and maximizing.
As we as we move further down the line.
Okay.
Yes.
Thanks, So much and then on HCV, how should we think about the PK and efficacy affirm your thoughts are there and there's a fear and the patient population that actually have compensated cirrhosis compared to those without cirrhosis in your lead in cohort and then are you considered including patients with.
D compensated cirrhosis and also HIV co infection and your phase three so it's a similar.
Was to pursue a similar label at Appaloosa.
And then separately who are these low hanging fruit to patients that you could target if it's approved.
Sure.
I'll ask maybe you want to.
So to address the question on them.
Maybe you could comment as well so I ran some yes.
Well I think the PK, we don't anticipate major changes.
Teekay or even PK PD and viral kinetics.
As you saw in the in the data that we have Sean <unk>.
This was very fast.
Even in the threes, which are really borderline compensated cirrhotic. So we think that we've seen also in previous trials that the PK should be the same.
And that is for the compensated cirrhotic or the compensation metrics as a great population I think that we are going to have targeted.
It's.
Probably a little bit later.
For the HIV are certainly we are considering inclusion in phase III trial.
It's like you said.
Great unmet need population.
Yes.
Chili's.
Just one comment.
For the.
The compensated patient obviously.
That would be we believe a major advance because we foresee at least we see the potential to eliminating ribavirin.
Right now you have only one.
Proved.
Treatment, which is a combination of our coosa and ribavirin in those pension now let's not forget that this is a patient population that is very difficult very likely trial youre going to have some best.
So obviously we.
We foresee that this.
This population that would be very likely not part of the phase III program.
The regulatory authorities, we will request that but more as a post NDA commitment but definitely.
We definitely want to go there maybe not with eight week.
Probably a 12 week would be already highly differentiated.
With the elimination of revamping them and obviously these patients.
Do we acquire them.
The <unk>.
The best.
Chance of success.
And that the length of treatment.
Less of an importance than what we have with the patient population.
Just to share with you before.
Got it thanks, so much for taking our questions.
Okay.
I would now like to turn the conference back to Peter for closing remarks.
Thank you all for joining our fourth quarter and full year 2023 earnings conference call.
You as well for your continued support.
Ladies and gentlemen. This concludes today's conference you may now disconnect.
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Good afternoon, everyone and welcome to the <unk> Pharmaceuticals fourth quarter 2023 financial results and business update conference call. At this time all participants are in a listen only mode. Following the formal remarks, we will open the call up for your questions I.
I'd now like to turn the call over to Jenny Barnes Senior Vice President of Investor Relations and corporate communications at CFR Masoud calls. This Barnes. Please proceed.
Good afternoon, everyone and welcome to <unk> Pharmaceuticals, fourth quarter, and full year 2023 financial results and business update conference call earlier today, we issued a press release, which outlines the topics. We plan to discuss you can access the press release as well as the slides that we'll be reviewing today by going to the investors section of our <unk>.
Web site at IR Dot <unk> Dot Com with me today from <unk> are Chief Executive Officer, and founder Dr. John Here, Some Adobe Dr. <unk> <unk>, Chief Medical Officer, Chief Development Officer, Dr. Janet Hamon, Chief Financial Officer, and Executive Vice President of legal Andrea Corcoran and Archie.
Commercial officer, John Bair breakdown, they will all be available for the Q&A portion of today's call before we begin the call and as outlined on slide two I would like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the securities.
And Exchange Commission, which we encourage you to read our actual results may differ materially from what is discussed on today's call with that I'll now turn the call over to Sean here.
Thank you Jonathan.
Good afternoon, everyone and thank you for joining us I will begin on slide <unk>.
Looking back at our substantial progress throughout 2020.
Proud of the strong operational execution, we achieve across so antiviral programs.
Joining three highlights from our COVID-19 program include the ability to leverage global searches to meaningfully advance our phase III Sunrise III study.
This was made possible by the expansion of the global footprint and the broadening of the eligibility criteria for high risk patients.
So far in 2024, we continue to observe encouraging enrollment trends for Sunrise shrink.
Reflecting the continuing unmet medical need we were granted fast track designation by the FDA for the <unk>.
Relation of Benny caused the vehicle <unk> 19.
We have continued to demonstrate.
Possibly we remain fully active against all variance tested in vitro, including $10 million variance related to the micro.
The profile for <unk> <unk> is supported by robust clinical data, including favorable efficacy and safety with no drug drug interaction.
We believe that <unk> has the potential to address the key limitations of Cowen.
COVID-19 oral therapies for.
For HCV.
2023 highlights include achieving regulatory approvals for short eight week treatment for the global Phase III trial of the combination of any faas BVA and <unk> for the treatment of HCV.
The rapid enrollment of the leading cohort, which has led to exciting.
Results that we where do we view today.
We demonstrated in vitro synergy of the combination of <unk>, possibly on the residence Vail.
Our new compelling potency profile against major HCV resistance mutations.
We are now evaluating several fixed dose combination tablets and preparation for the phase III program and subsequent commercialization.
And we presented and published correct clinical and clinical data in support of this program.
We believe many philosophy of any combination with us via can significantly improve upon the current incentive care by offering differentiated chalk eight weeks protease inhibitor free treatment, which has been well tolerated and has limited potential to address.
Drug interactions.
Moving to slide four.
<unk> vision is focused on the discovery and development of antiviral drugs for the treatment in Q4 serious viral diseases, where there is a significant unmet medical need and where we can make a huge difference.
As you know we believe that.
But as you anticipate.
And the recent winter surge remind us.
<unk> dominant on Valiums like GM alone.
Thriving despite the lasers vaccine booster and treatments.
The SaaS <unk> accumulating mutations.
With acid substitution.
Faster than.
And then any other than d'amico any ross highlighting the desperate need for broader and more diversified arsenal of safe <unk>.
Tolerated.
Z to prescribed oral anti volatile periods.
Our team continues to efficiently execute our global phase III trial.
I am very pleased to announce today that we have achieved another significant clinical milestone and surpass enrollment of 40 and 100 patients triggering our second interim analysis in the supportive care monotherapy cohort.
This is an important milestone.
<unk> for the data review by the independent the SMB from safety and facility.
For Sunrise.
We anticipate several upcoming events.
Clothing, the first interim analysis in March.
Secondly, chairman analysis in the second quarter of 2024.
And topline results during the second half of 2024.
Any thoughts would be as a potential to address many of the key limitations of <unk>.
<unk> COVID-19 therapies, including safety.
The liability.
Drug drug interactions.
Grow is.
Is to deliver best in class III.
So the menu for patients for whom to current standard of care is suboptimal or unsuitable.
As part of a multi pronged approach against COVID-19, we.
We continue to also make progress with that.
Our discovery program focused on our highly differentiated second generation protease inhibitor and we expect to provide an update midyear.
For our phase II HCV program as stated earlier.
We share the results with confirm at 98% as we are for <unk>.
Post treatment in the leading cohort of our phase II combination eight weeks Doug.
So where do we view these results in more details.
Our goal for this program is to substantially enhance the current set of care by offering a short.
A two week protease inhibitor free treatment that is well tolerated with low potential risk or drug drug interaction for all HCV patients.
Importantly, we are in a strong financial position to execute our strategy with $578 $1 million of cash and cash equivalents as of December 31st with a runway mtc pace through 2026.
Andrea will provide a detailed update on our financial position during today's call.
I will now turn the call over to <unk> for an update on our HCV program.
Thank you Cynthia.
Turning to slide six despite current treatment option HCV continues to be a health crisis in the U S of.
As Jim noted earlier, there are approximately $2 4 million people infected with HCV in the U S. Despite availability of oral treatments.
Recent trends indicate they are more new infections on wing sections dunk, yes or no.
Yearly basis.
These statistics highlight the need to improve the HCV treatment landscape.
The Colombian then you call Sylvia and <unk> has the potential to substantially improve upon the current standard of care by offering a short eight.
With <unk> <unk> inhibitor free treatment with less side effects and no.
A low risk for drug drug interactions.
Based on our market research with Kols and high prescribers. These attributes are very critical for a new treatment you will see on the next slide.
Moving to slide seven welding.
While the introduction of direct acting Antivirals have transform HCV treatment significant unmet needs still exist.
In recent quantitative market research conducted by our payout with over 150 U S physician or high risk <unk> or with <unk> only 6% of this.
Patients reported that they have no unmet needs regarding HCV treatment.
Kian, let needs emerging in this research with shorter length of treatment and higher efficacy, particularly in HIV co infected patients as well as fewer contra indications as detailed on the right hand of the slide.
Please note that currently approximately.
17% of patients do not complete their treatment regimen, mcmeen convenient and shorter treatment duration of particular importance to prescribers.
Slide eight outlines our phase two open label study of 550 milligrams of <unk> in combination with 180 milligrams of <unk> once daily for eight weeks, we plan to enroll up to 289.
Nice patients across all genotypes.
In the initial cohorts sustained biological response.
At week four was used as the decision criteria to reinitiate enrollment to complete the phase two study.
Primary endpoint of this study is FBS at.
At week 12, and this will be reported for all patients on study completion.
Slide nine highlights the patient demographics and baseline characteristics in the leading cohort of the phase II.
<unk> label study of <unk> <unk>.
Patients with <unk> naive.
Some medium age of 47 years old. This cohort was comprised of non cirrhotic patients only hallway. Please.
Please note that 10 patients had fibrosis stage III on what advanced liver disease stage, which is borderline with cirrhosis in the second part of the phase two study.
Cerotic patients will also be involved.
Moving to slide 10, we are excited to share with you today that the final results from the phase two combination study and the leading cohort confirms an SBA four of 98% post treatment across all genotypes.
In January we initiated enrollment to complete this study in up to 280 basis with top line results anticipated in the second half of 2024.
Kevin shows the on treatment biokinetics of individual patient data.
Weak for all 60 patients in this cohort have viral load.
Or below the lower limit of quantification. Therefore is very rapid kinetics across all genotypes supported eight week regimen and compare favorably.
She is the only approved eight week treatment for HCV.
On slide 12.
The combination of <unk> <unk> was generally safe and well tolerated in this cohort of 60 patients there were no drug related <unk>.
A replay of this event no discontinuation and adverse events were mostly mild.
Turning to slide 13 to summarize our progress in HCV based on the positive leading cohort data we initiated enrollment in January for the remainder of the phase two trial will.
It will help advance and Goldman and achieve representative genotype distributions. We are increasing this study's footprint to approximately 50 clinical sites in 15 countries.
In addition, I'll go to the first half of 2024, we are conducting phase one studies in the U S for the selection of the bank.
Fixed dose combination tablet, which will be evaluated in the phase III program.