Q4 2021 Atea Pharmaceuticals Inc Earnings Call
Operator: Drone, Drone, Drone Ladies and gentlemen, your Atea Pharmaceuticals fourth quarter and full year 2021 financial results conference call will begin momentarily. [music] Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals fourth quarter and full year 2021 financial results conference call. At this time, all participants are in a listen only mode.
Ladies and gentlemen, please standby you Saf pharmaceuticals fourth quarter and full year 'twenty to 'twenty, one financials missile conference call will begin momentarily. Thank you.
[music].
Good afternoon, ladies and gentlemen, welcome to the <unk> Pharmaceuticals fourth quarter and full year 2021 financial results 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 MS. Jenny Barnes Senior Vice President of Investor Relations and corporate communications at <unk>. Mr. <unk>. Please proceed.
Operator: Following the formal remarks, we will open the call up for your questions. I would now like to turn the call over to Ms. Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals.
Jonae Barnes: Thank you and good afternoon everyone, and welcome to Atea Pharmaceutical's fourth quarter and full year 2021 financial results conference call. This afternoon, 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 investor section of our website at ir.ateafarma.com. With me today from Atea are Chief Executive Officer and Founder, Dr. John Pierre-Santosi, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Vav They will all be available for the Q&A portion of today's call.
Thank you and good afternoon, everyone and welcome to Acadia Pharmaceuticals fourth quarter and full year 2021 financial results Conference call. This afternoon, 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 <unk> Dot Com with me today from <unk>, Our Chief Executive Officer, and founder Dr. John Pearson.
Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer, and Executive Vice President of legal and during our Corcoran and our Chief Commercial officer, John Bev recap they will all be available for the Q&A portion of today's call before we begin the call is outlined on slide two I would like to remind you that today's discussion will.
Jonae Barnes: Before we begin the call, as outlined on slide two, I would like to remind you that today's discussion will contain forward-looking statements that involve risk 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.
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 John here.
Jonae Barnes: With that, I'll now turn the call over to John Pierre. Thank you, Jonae. Good afternoon, everyone, and thank you for joining us today.
John Pierre-Santosi: I will begin on slide three. From the beginning, Atea Gold has been to discover breakthrough drugs against severe RNA viral diseases. Today, with the evolving nature of COVID-19, it is clear that a combination of direct acting antivirals will be needed to address this very challenging viral disease. What have we learned in the past year?
Thank you John good.
Good afternoon, everyone and thank you for joining us today.
I'll begin on slide <unk>.
So at the beginning at the strength of this breakthrough drugs against Covid.
Diseases today.
The evolving nature of COVID-19, it is clear that combination.
Directly acting antiviral would be needed to address this very challenging viral disease.
John Pierre-Santosi: We are dealing with a viral disease that is rapidly evolving from variant to variant within three to six months, with major pandemic surges, such as what we saw with Delta last summer and now with Omicron. We are also starting to see the significant public health and economic impact of the long-cover, which will continue to have long-term effects on individuals and society as well. This virus, which is constantly and rapidly mutating, is now evading the vaccine and most of the monoclonal antibodies, and it's clear that we urgently need several all therapeutics with different mechanisms of faction to deal with the challenges we face.
So what have we learned in the past year.
Ending with a viral disease, which is rapidly evolving from vein to vein within three to six months with major pandemic searches such as what we have seen with Delta last summer and or Michael.
We are also starting to see the significant property Alf.
And the economic impact of <unk>.
Long covet, which would continue to have long term effects.
Individuals and society as well.
This virus, which is constantly and rapidly mutating is now evading vaccine and most.
Monoclonal antibodies.
And it's clear that we urgently need several all therapeutics.
With different mechanism of actions too.
To deal with challenging Ross.
John Pierre-Santosi: While the protease inhibitor class has recently shown good efficacy against COVID-19, historically, we have learned that this class of drugs has a low barrier to resistance, with rapid development of resistance strains, especially in immunosuppressed individuals, where we can see viral replication will continue for weeks and even months. Neucleotide drugs are being the backbone of successful oral combination regiments against many severe RNA viral diseases to mitigate this resistant issue and also to enhance Africa.
While the <unk> inhibitor class.
Recently showed good efficacy against COVID-19, historically, we have learned that this class of drugs as a low barrier to resistance with rapid development of resistance strength, especially in the immuno suppressed individuals where we can see viral application.
We will continue for weeks and even months.
At least I drugs have been.
Backbone of successful or combination regiments against many severe.
All diseases to mitigate this resistance issue and also to enhance efficacy, we believe that our nuclear type any false review or 85 to seven.
John Pierre-Santosi: We believe that our nucleotide benifosbuvir, or AT527, has the potential to be a preferred nuke of choice for a combination regimen with a protease inhibitor for the treatment of COVID-19. Our team has experience in leading development efforts for several combination therapies for RNA viruses over the years. And we believe that we can deliver, again, a long-term solution with a combination of benipozivir and a protease inhibitor for the treatment of COVID-19. Now, turning to HCV.
Potential to be a preferred nuc of choice for a combination regimen with a protease inhibitors for the treatment of COVID-19.
Our team.
Has experience in leading developer and therefore, several combination therapies for RNA viruses over the years and we believe that we can deliver again.
Long term solution with a combination of any possible via kind of protease inhibitor for the treatment of COVID-19.
Turning to HCV.
John Pierre-Santosi: The recent in-licensing of Roosevelt's Reveal combined with Benny Ford's Reveal will accelerate the timeline of our HCV program and may result in the best-in-class pangenotypic hepatitis C combination regimen. However, there is still a need for improved HCV treatment with shorter treatment duration, better convenience, and elimination of revival in patients with advanced liver disease. As John will discuss later in the call,
The recent in licensing of who is as we.
Combined with Ben a closer view will accelerate the timeline of our HCV program.
And May result in the best in class pension that typically hepatitis C combination regimens.
There is still a need for improved HCV treatment with shorter treatment duration, better convenience and to eliminate ribavirin in patients with advanced.
Liver disease.
As John will discuss later in the call. The hepatitis C market is large and the global HCV market in 2021 approach $4 billion.
John Pierre-Santosi: The hepatitis C market is large, and the global HCV market in 2021 is expected to approach $4 billion, whereas the US represents about 50% of the market. We are also advancing our third clinical program, AT752, a nucleotide analog generated from our Purin platform. Dengue fever is the most prevalent mosquito-borne viral disease with a large global disease burden and lack of antiviral treatment. We successfully completed the Phase 1 study late last year, and 87.52 will now progress to a Phase 2 clinical trial conducted in dengue-endemic countries, as well as a challenge study conducted in the U.S. Let's now review our strategy for COVID-19. Moving to slide five.
With the us representing about 50% of the market.
We are also advancing our third clinical program <unk> 752, a nucleoside analog generated from our Purion platform.
Dengue fever is the most prevalent mosquito borne virus disease with a large global disease burden and lack of antivirals treatments.
We have successfully completed the phase one study late last year and 80 752 will now progress to.
A phase II clinical trial conducting in dengue endemic countries.
Well as a challenge study conducted in the U S.
Let's now we view.
Our strategy for COVID-19.
Moving to slide five.
John Pierre-Santosi: Our vision for Benifaz-Rivera is to be a nuke of choice, as I've said, for the combination treatment with a protease inhibitor for COVID-19. Benny Fossbeville, Targeted Viral RNA Polymerase, which, as you may know, is a highly conservative design critical to the biorepication and the transcription of this world. Unusually, Vinny Forsby, he has a mechanism of action or MOA with dual targets. It is both a chain terminator and without introducing, Any Invitations? a new mutation in the vowel genome, especially in the spike protein, as has been shown with molybdenum.
Our vision.
So a penny positive here is to be a nuc of choices outside.
The combination treatment with a protease inhibitor for COVID-19.
John Pierre-Santosi: It is also inhibiting the NIRIN function, which is also a functional function of the RNA polymerase and which is also critical to viral replication. Thus we believe that this MOA provides the potential to create a high barrier to resistance, as well as provide antiviral activity across any variants of concern. Details relating to this MOA were recently published in the peer-reviewed journal Nature Communications. So, based on this unique MOA, we can anticipate that Benifaz-Vivir will maintain its activity as this virus continues to evolve in all clinical studies today.
Benny Fosterville targets the viral RNA polymerase.
Which as you may know is a highly conserve enzyme critical to the viral application and the transcription of these raws.
Uniquely.
Any possibility as a mechanism of faction of MAA with dual targets.
It is both a chain terminated.
Without introducing.
Any mutation.
So a new mutation in vivo genome, especially in the Spike protein has been shown with multi Peoria.
It is also inhibiting the near end function, which is also a functional function of the Io They put anyways and which is also critical to the viral replication.
Thus, we believe that this provides the potential to create a high barrier to resistance as well as provide antiviral activity across any variance are concerned.
In detail.
Relating to this.
Were recently published in the peer reviewed journal nature Communications.
So based on this unique.
We can anticipate there has been a fast review will maintain its activity.
<unk> continued to evolve.
In all clinical studies to date many funds.
John Pierre-Santosi: Benifold's variant was shown to be generally safe and well tolerated. Of note, it is non-mitogenic, with no reproductive toxicity, and is non-teratogenic, and it is the safety profile that I believe makes many think reveal uniquely well-suited, not only for combination treatment regimens in COVID-19, but also for HCV, which we'll review in this presentation. Thank you, Jean-Pierre. Good afternoon, everyone.
It was shown to be generally safe and well tolerated.
It is non mutagenic.
There was no reproductive toxicity and is not there with the agenda.
And it is the safety profile, we should believe that makes many positive you're uniquely well suited not only for combination treatment regimen in COVID-19, but also for HCV, which we view Dewey.
Doing this presentation.
I will now end the call over to Chad.
Janet Hammond: Let's turn to slide six. Getting Benny Foster there for COVID-19 remains a top priority for us. Combination therapy using multiple drugs with different mechanisms of action has proven important in limiting the development of resistance for many RNA viral diseases such as HDV and HIV. We're working diligently on our COVID-19 clinical development program, taking into account the continuously evolving COVID-19 landscape, and we look forward to sharing with you further information on this plan in the future. This group is for hepatitis C, and I'm going to hand the call over to Josh. Thank you, Janet. Good afternoon. Let's turn to slide eight.
Thank you Sean good afternoon, everyone, let's turn to slide six.
Advancing Benny.
From COVID-19 remains a top priority for us.
Nation, Turkey, using multiple drugs with different mechanisms of action proving important timid teams develop resistance for many R&D balance.
Such as HCV and HIV.
We're working diligently on all COVID-19 clinical development program, taking into account the continuously evolving COVID-19 landscape.
And we look forward to sharing with you.
Information on this plan in the future.
Let's see.
<unk> I'm going to hand, the call over to Josh.
Yeah.
Thank you John Good afternoon, let's turn to slide eight.
John Vavricka: The market for Hepatitis C is large, with the global HCV market approaching $4 billion, with the U.S. representing approximately 50% of the market. This market size was achieved even during the height of the COVID pandemic. Despite the availability of direct acting antiviral oral combination regimens for the treatment of HCV, there remains a large under-served HCV patient population which continues to grow in the United States. A large portion of this increase in incidence is attributed to the opioid crisis, IV drug use, and HCV reinfection, especially among younger adults. We believe that a new, best-in-class, pan-geotypic HCV regimen that has a shorter treatment duration and is more convenient has the potential to achieve blockbuster status.
The market for hepatitis C is large with 2021 global HCV market approaching $4 billion with the U S representing approximately 50% of the market.
This market size is achieved even during the height of the Covid pandemic.
Despite the availability of direct acting anti viral combination regimens for the treatment of HCV. There remains a large underserved HCV patient population, which continues to grow in the United States.
Large portion of this increase in incidence is attributed to the opioid crisis IV drug use and HCV reinfection, especially among younger adults.
We believe that a new best in class Pan Genotypic HCV regimen that has a shorter treatment duration and this work can be.
Has the potential to achieve blockbuster status.
John Vavricka: Additionally, a more potent nucleotide-based regimen should eliminate the need for ribobiring in patients with de-compensated serenity. I'll now hand the call back to Janet. Thanks, John. Moving to slide nine, we're very pleased to have obtained an exclusive worldwide license from Merck to develop, manufacture, and commercialize Ruzizia, an oral Ns5a inhibitor. We're excited about Ruth's best profile.
Additionally, a more potent nucleotide based regimen should eliminate the need for ribavirin in patients with compensated cirrhosis.
I'll now hand, the call back to Jay.
Thanks, John moving to slide nine.
Keith to have obtained an exclusive worldwide license from back to Japan, the manufacture and commercialize.
And its Friday inhibitor.
Janet Hammond: It is one of the most potent NFCV inhibitors with envy, peractivity, and the peak of murder range against all seven FCV genotypes. Extensive clinical studies conducted by Merck showed potent antiviral activity in HCV-infected patients. In over 1,200 patients at daily doses of up to 180 mg for up to 24 weeks, a favorable safety profile with no consistent treatment-related changes in laboratory parameters was observed.
We're excited about the sales profile. It is one of the most potent <unk> inhibitors with in vitro activity in the Picomolar range against all seven HCV genotype.
Extensive clinical studies of <unk> conducted.
Conducted by Merck.
<unk> antiviral activity in HCV infected patients.
The 1200 patients daily doses of up to 180 milligrams 24 weeks.
<unk> safety profile with no consistent treatment related changes in dabashi parameters for success.
Janet Hammond: We further support the combination of benifostavir and rosavir in patients. We've conducted in vitro experiments either alone or in combination. As shown in the figure on this slide, these experiments demonstrated that the combination resulted in substantially greater inhibition of HCV replication than either agent alone, suggesting a significantly synergistic antiviral effect between the two inhibitors. Once again, a key reason why we're in Nice and Struse is that there was this advanced development stage, which decreases development risks and also provides the opportunity to create a best in class, paying a specific combination therapy with Benny Foster in a short time.
To further support the combination of Benny Foster that envisaged and patients we've conducted in vitro experiments either renewing or in combination.
As shown in the figure on the slide these experiments demonstrations of the combination resulted in substantially greater inhibition of HBV replication than either agent alone.
<unk> significantly synergistic antiviral effect between the two inhibitors.
Once again, a key reason why we in licensed squeezes that advanced development stage, which decreases development risks and also provides the opportunity to create a best in class Pan Genotypic combination therapy with <unk> in a shorter timeframe.
Janet Hammond: [inaudible] Now let's move to Benny Foster, their profile in HCV, which is shown on slide 10. Ben Fosterville was the primary professor of the TAIR's original program before COVID hit, is about tenfold more potent than cephosphoria in vitro against a panel of laboratory strains and clinical isotopes, and remains fully active against the phosphovir-resistant strain. In monotherapy, Berny-Fosbever demonstrated a potent response, and uniquely, viral kinetics were consistent across all genotypes, including genotype 3, as well as in patients with compensated cirrhosis. As you can see in the chart, there is a rapid and steep barrel load decline of around four logs within 72 hours.
Now, let's move to Bangkok previous profiling, HDD, which is shown on slide 10.
So that was the primary focus of the original program before Covid hit.
It's about 10 fold more potent than surface revert in vitro against the timing of laboratory strange and turn the call estimate Andrew.
And we remain fully active against severe resistant strains.
Monotherapy Fannie fast because they are demonstrating and unique T. Viral kinetics are consistent across all genotypes, including genotype three as long as in patients with compensated cirrhosis.
As you can see in the chart there was a rapid and steep decline of around four notes within 72 hours.
Janet Hammond: This rapid and steep decline is important to prevent the potential for the development of NSIVA resistance, especially in the hard-to-treat genotype 3 population. Benifospovir at 550 mg supports once-daily dosing, and based on its safety, tolerability, and efficacy profile to date, it's an ideal candidate to develop in combination with rhesus. Moving to slide 11, we're very excited about our H2B combination development plan and believe that there is still room to improve on the standard of care. However, significant data has been generated for birth drug candy.
This rapid and steep decline is important to prevent the potential development of a new savi resistance.
Especially in the hard to treat genotype <unk> population.
Thank you Fox because you're at 550 milligrams supports once daily dosing based on its safety Tolerability and efficacy profile to date, it's an ideal candidate to developing combination with reasons yes.
Yeah.
Moving to slide 11, we're very excited about our HCV combination development plan and believe that there is still room to improve on the standard of care.
A significant data is being generated from Paris drug candidates and as soon as synthesis has been consistent for the reasons that clinical trial materials, we will move quickly into a state of the.
Janet Hammond: And as soon as synthesis has been completed for the root of their clinical trial materials, we will move quickly into a phase examination study. We anticipate initiating the study in the second half of the year. Our Phase II Development Program will evaluate treatments of shorter duration and will include patients with both compensated and decompensated liver disease. Let's now move to our third stage two program for dengue fever, and I'll hand the call over to John. Thanks, John.
Nation study.
We anticipate initiating the study in the second half of the year.
Our phase two development program will evaluate treatments of shorter duration and will include patients with both compensation and de compensated liver disease.
Next I'll move to <unk>.
For dengue fever, and I'll hand, the call over to John .
Thanks Shannon.
John Vavricka: Dengue is the most prevalent mosquito-borne viral disease, and it affects almost 400 million individuals on a yearly basis. Thank you, pandemic in over 100 countries and greater than half the world's population is at risk. There is a significant unmet medical need, and the global economic burden is estimated to be between $8 and $9 billion. There are no treatments for dengue, and the approved vaccine has a less than optimal profile with safety concerns and a restricted label.
Thank you is the most prevalent mosquito borne viral disease and its effects on this 200 million individuals on a yearly basis.
Thank you the endemic in over 100 countries and greater than half the world's population is at risk.
There is a significant unmet medical need and the global economic burden.
Estimated to be between $8 million to $9 million.
There are no treatments for dengue.
The approved vaccine is less than it has lessened an optimal profile the safety concerns and a restricted label a breakthrough drug Kennedy 80, 72 is the purion nucleotide prodrug derive from our platform.
John Vavricka: Our breakthrough drug candidate, AT752, is a purine nucleotide prodrug derived from our plasma. It has shown potent in vitro activity against all serotypes tested and demonstrated strong efficacy in animal models. I'll now hand the call back to Janet to review our program.
It has shown potent in vitro activity against all serotypes tested and demonstrated strong efficacy in animal models.
I'll now hand, the call back to John to review our program got it.
Janet Hammond: Thank you, John. As shown on slide 14, last year, we initiated and successfully completed a randomized, double-blind, placebo-controlled, single and multiple ascending dose phase one study to evaluate the safety, tolerability, and pharmacokinetics of 8752 in healthy subjects. In the Phaethon trial, AT752 was well tolerated in 65 healthy subjects who administered either single or multiple doses. There were no serious adverse events reported, and most adverse events were considered mild, and there were no changes in bariatric parameters.
Thank you Tom.
On slide 14, Nokia, we initiated and successfully completed a randomized double blind placebo controlled single and multiple ascending dose phase one study to evaluate the safety cargo ability in pharmacokinetics of 80 752 in healthy subjects.
In the phase II trial, 87 texture was well tolerated in 65 monkey, Okay, who administered either single or multiple doses.
The new serious adverse events reported and most adverse events were considered mild and there were no changes in laboratory parameters.
Janet Hammond: In addition to the clinical work, we also published supportive in vitro and in vivo data of AT752 in peer-reviewed journals. The data published in Antimicrobial Agents and Chemotherapy showed that AG752 has potent retroactivity against all dengue virus serotypes and also other plague viruses. 8752 was also shown to reduce viremia and improve animal health and survival in a mouse model of dengue virus. In addition, data demonstrating the in vivo efficacy of AT752 against yellow fever virus were recently published in the peer-reviewed journal PLOS Neglected Tropical Diseases.
In addition to the clinical work. We also have published portion of in vitro and in vivo data of 80 752 in pair with you John .
The data published in the antimicrobial agents and chemotherapy.
Showed that 80 752 has perceived in vitro activity against all dengue virus Eric Katz.
And also other thank you Barak.
875, two was also shown to produce viremia and improve animal health and survival in a mouse model of dengue back in.
In addition data demonstrating the in vivo efficacy of <unk> preference is to again see the virus was recently published in the peer reviewed journal.
Neglected tropical diseases.
Janet Hammond: The published data showed that AT752 reduced viremia and improved disease outcomes and enhanced the model of yellow fever virus. There are two key studies that we are planning to conduct in 2022 for the Dengue Program. On slide 15, which is the first study we're planning in the United States, healthy volunteers are dosed with A3752 or placebo and then administered a live dose of dengue virus.
Data showed that 80, 752 reduced viremia and improve disease outcomes in a hamster model ability desire.
Janet Hammond: Subjects are closely monitored within a highly controlled setting, allowing the assessment of viral load and the viral kinetics to be compared between treatment. Results are expected in the second half of the year. Pictured on slide 16 is the second key study we plan to initiate during the first half of this year. This is a Phase II proof-of-concept treatment study in patients with dengue fever, and this study will be conducted in dengue-endemic countries around the world.
There are two key studies that we are planning to conduct in 2022 for the dengue program.
On Slide 15 is the first study, which is the human challenge study, we're counting in the United States.
In this study healthy volunteers are dosed with <unk> <unk>, two or placebo and then administered lighters.
Of dengue virus.
Subject to closely monitor within a highly controlled setting, allowing the assessment of viral load and the viral kinetics to be compared between treatment groups.
Also expected in the second half of the year.
Pictured on slide 16 is the second key study we plan to initiate during the first half of this year.
It is a phase two proof of concept treatment study in patients with dengue fever.
And this study will be conducted in Jamie dengue endemic countries around the world.
Janet Hammond: This study is designed to assess antiviral activity, safety, and pharmacokinetics of multiple doses of 87-5-2 with a primary endpoint of change from baseline in barrel load. 8752 or placebo will be administered early for 5 days in patients with dengue infection who present within 48 hours of developing fever.
This study is designed to assist antiviral activity safety and pharmacokinetics of multiple doses of 87 two.
With a primary endpoint of change from baseline and boundaries.
87, <unk> to placebo will be administered Arnie for five days in patients with dengue infection, who present within 48 hours of developing fever.
Andrea Corcoran: The study will be initiated soon, with initial results anticipated late in 2022. I'm going to hand the call over now to Andrea so she can review our financial information. Thank you, Janet. As Jonae mentioned in her introductory remarks this afternoon, we issued a press release containing our financial results for the fourth quarter and full year of 2021. For the fourth quarter of 2021, the increase in R&D expenses in comparison to the fourth quarter of 2020 was principally driven by an increase in external clinical development and manufacturing expenses incurred primarily in conjunction with the development of the AT-527 for the treatment of COVID-19 and, to a lesser extent, AT-752, which is being developed for dengue fever. We also had an increase in internal spend, primarily attributable to an increase in Atea personnel-related expenses.
The study will be initiated soon with initial results anticipated later in 2022.
Going to hand, the call over now to <unk> to review our financial information.
Andrea Corcoran: Of note, our external expenses include our share of costs incurred by Roche relating to the beneficiaries of Phase 2 Moonsong, Phase 3 Morning Sky, and Phase 3 Meadowspring Clinical Trials. These shared costs include external costs incurred by Roche in connection with the conduct of the studies and FTE costs for Roche personnel who are working on this program. The increase in G&A expenses, quarter over quarter, was primarily due to an expansion of our organization and consisted principally of an increase in payroll and personnel-related expenses.
Thank you Tim.
As Tony mentioned in her introductory remarks. This afternoon, we issued a press release containing our financial results for the fourth quarter and full year of 2021.
Statement of operations and balance sheet can be found on slide number 18 and 19.
For the fourth quarter 2021, the increase in R&D expenses in comparison to the fourth quarter of 2020 was principally driven by an increase in external clinical development and manufacturing expenses.
Primarily in conjunction with the development of the 85 to seven for the treatment of COVID-19, and to a lesser extent 87 type two which is being developed for dengue fever.
We also had an increase in internal spend primarily attributable to an increase in personnel related expenses.
Of note our external expenses include our share of costs incurred by Roche relating to very possibly Rfps to Moon song Phase III morning, Sky days through metal spring clinical trials.
<unk> costs incurred.
<unk> external costs incurred by Roche in connection with the conduct of the studies and FTE cost for Roche personnel, who are working on this program.
The increase in G&A expenses quarter over quarter was primarily due to an expansion of our organization and consist principally and an increase in payroll and personnel related expenses.
Andrea Corcoran: I am pleased to report that we ended the year with a strong balance sheet to support our clinical development programs. As of December 31, 2021, cash and cash equivalents amounted to $764.4 million. For financial guidance going forward, please note that during the first quarter of 2022, we expect to incur residual costs from Roche associated with the winding down and closure of the Moonsong, Morning Sky, and Meadow Spring trials. The timing of R&D expenses in 2022 is currently expected to be back and loaded.
I am pleased to report that we ended the year with a strong balance sheet to support our clinical development programs as of December 31, 2021, cash and cash equivalents amounted to $764 $4 million.
For financial guidance going forward. Please note.
During the first quarter of 2022, we expect to incur residual costs from Roche associated with the wind down and close out of the mood song morning, Sky and metal spring trials.
The timing of R&D expenses in 2022 is currently expected to be back end loaded. This assumption is driven by clinical plans, which currently contemplates the initiation of the phase III <unk> trial agenda. Just describes the challenge study during the first half of the year as well as initiation.
Andrea Corcoran: This assumption is driven by clinical plans, which currently contemplate the initiation of the Phase 2 Dengue trial, as Janet just described, and the challenge study during the first half of the year, as well as the initiation during the second half of the year of the Phase 2 Benifacivir combination trial for COVID-19 and the initiation of the Phase 2 combination trial of Benifacivir and Rucivir for HCV, which will likely be later in the year For spending going forward, we will be taking a disciplined, biotech-focused approach.
During the second half of the year of the phase III any thoughts severe combination trial for COVID-19, and initiation of the phase two combination trial any thoughts for the year and new severe for HCV, which will likely be later in the year.
We're spending going forward, we will be taking a disciplined biotech focused approach.
Andrea Corcoran: As previously mentioned, expenses in 2021 included cost sharing with Roche relating to external spend associated with Moonsong, Morning Sky, and Meadowspring COVID-19 clinical trials and Roche FTEs involved in the COVID-19 program, which was a big pharma model. We anticipate to have cash runway to 2025, and we plan to be very dilution sensitive as we move forward.
Previously mentioned expenses in 2021 included cost sharing with Roche relating to external spend associated with moves on good morning, Sky and metal spread COVID-19, clinical trials and Roche FTE involved in COVID-19 program, which was a big pharma model.
We anticipate to have cash runway through 2025, and we plan to be very dilution sensitive as we move forward.
John Pierre-Santosi: I'll now turn the call back over to Jean-Pierre for his closing remarks. Thank you, Andrea. In closing, we are building a pipeline with the vision to be a leading anti-viral company. We plan to continue to build out our pipeline of antiviral product candidates by broadening our nucleotide pipeline with other classes of antivirals that may be used in combination with our nucleotide product candidates. In 2022, we expect to make meaningful progress across our three phase two programs for COVID-19, HCV, and dengue.
I'll now turn the call back over to Sean here for closing remarks.
Thank you Andrea and closing.
Building a pipeline that was the vision to be a leading <unk> company.
We plan to continue to build out our pipeline of <unk> product candidates.
Broadening our nuclear science pipeline with other classes of <unk> that may be used in combination with our nucleoside product candidate.
In 2022, we expect to make meaningful progress across our three phase III program for COVID-19, HCV and thank you.
John Pierre-Santosi: These programs have the potential to provide global solutions for patients suffering from severe viral diseases. The data sets for these clinical trials will be important readouts and should be key inflection points for our company. Importantly, as Andrea has indicated and presented, we have the financial strength with a runway through 2025 and a seasoned management team to advance this program. That's all right.
These programs have the potential to provide global solutions.
Patients suffering from severe of all diseases.
The data set.
These clinical trials will be important readouts.
It should make key inflection points for our company.
Importantly.
Some drag as indicated and presented.
We have the financial strength with a cash runway through 2025.
And the season management team to advance these programs.
As always we thank.
Operator: We thank you for your continuous support as we build Atea into a global leader in the discovery, development, and commercialization of oral therapies that address the unmet medical needs of patients with severe bowel disease. With that, Operator, we will now open the call to your questions. Thank you. Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the hashtag.
Thank you for your continued support as we built <unk> into a global leader.
And the discovery development and commercialization of all therapies.
Dress unmet medical needs of patients with severe viral diseases.
With that operator, we will now open the call up to your questions.
Thank you ladies and gentlemen, if you have a question at this time. Please press the star and then the number one key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the hash key.
Operator: We have the first question, which comes from the line of Matthew Harrison of Morgan Stanley. Your line is now open; you may ask your question. Great, thanks for taking the questions. Good afternoon. I guess two for me.
We have the first question comes from the line of Matthew Harrison of Morgan Stanley . Your line is now open you may ask your question.
Matthew Harrison: So first, when you're thinking about potential combination partners in COVID, you know, what do you think you need in terms of an agreement here? I mean, are there, do they, I don't know, just give me some sense in terms of how you get access to the drug and how you might think about those studies. Do you need a formal agreement or could you get access otherwise?
Great. Thanks for taking the questions. Good afternoon, I guess two for me so first when youre thinking about potential combination partners in Covid.
What do you think you need in terms of an agreement here I mean are there do they I don't know just give me some sense in terms of how you get access to drug and how you might think about those studies do you need a formal agreement or could.
Matthew Harrison: And then second, on dengue, just give us a sense of what sort of, I guess, clinical outcome here would be meaningful in these patients. Is it about duration of disease, you know, symptoms, et cetera? Thanks very much. Thank you, Matt, for your questions. Related to the first question, we are open to partnership, but at the same time, we are going to be very opportunistic to evaluate externally as we are doing right now internally in terms of patent evaluation for COVID. So as we speak, we are evaluating several opportunities, and I will foresee preferably in licensing rather than partnership, but we are definitely open to potential interaction with some of the players with maybe more advanced patent evaluation.
Because you get access otherwise.
And then second on dengue.
Just give us a sense of what sort of I guess clinical outcome here would be meaningful in these patients is it about duration of disease.
Symptoms et cetera, thanks very much.
John Pierre-Santosi: If we believe that they lead to potential best in class and compare them with the evaluation that we are doing right now with in vitro studies. Related to the second question, I'll let Janet address the second question. Janet?
Thank you Matt for your questions related to the first question.
We are open to partnership.
But in the same time.
Yes.
We are going to be very opportunistic.
Two.
Evaluate externally.
We are doing right now internally and term.
<unk>.
So as we speak.
Evaluating several opportunities.
And I would foresee preferably in licensing rather than the partnership but we are definitely open to.
Two.
Potential.
Interaction with some of the players.
Maybe more advance beyond if we believe that the.
It will lead to a potential best in class and compare with the evaluation that we're doing right now.
In vitro always in vitro studies related to the second question.
I'll, let jana to address the second question.
Got it.
Janet Hammond: Thanks, Jean-Pierre. So I think we have two studies, as I mentioned, a challenge study and a treatment study. So in the challenge study, really, it's a prophylactic model. So what we're going to be looking for is the absence of the development of viremia in patients who have been pre-administered A275-2. In the treatment study, patients who already have symptoms will be looking for reduction in viremia and also the prevention of progression to more severe dengue in these patients and reduction in symptoms. Thank you. Thank you. We had the next question. Come from the line of Mr.
Thanks, Tom.
We have two studies as I mentioned the challenge study under treatment studies in the challenge study.
This model to work against you and looking forward.
The absence of the development of viremia in patients who have been creating 87 sites.
And the treatment study.
Good questions that were already have symptoms and will be looking for reductions in viremia and also the prevention of progression to more severe dengue on these patients and reductions in <unk>.
Thank you.
Yeah.
Operator: Team Lugo of William Blair. Your line is now open. You may ask, "Hey, this is Lachlan on VITEM."
Thank you we had the next question comes from the line of Mr. Tim Lugo with William Blair. Your line is now open you may ask your question.
Hey, this is lachlan on for Tim Thanks for that.
Tim Lugo: Thanks for taking the questions. A couple on the Dengue program. How do you see the challenge study fitting into a regulatory process?
A couple on the dengue program.
How do you see the challenge study.
A regulatory process do you see that as a phase two or more.
Tim Lugo: Do you see that as a Phase II or more of a way of informing your plans for a Phase II? And second of all, after the Phase I data, have you sort of narrowed down on a dose or multiple doses and dose regimens you plan to evaluate in the Phase IIs for Dengue? Janet?
Informing your plans for a phase two.
Janet Hammond: So I think we would consider the study probably to be somewhat of a hybrid, the challenge study, as these are healthy volunteers who are being administered a challenge dose. So I'm not sure how you would classify it from a regulatory perspective, but I think it's going to be very informative because I think there is certainly scope for an effective drug for dengue fever to be able to be used both for treatment and for prophylaxis.
Okay.
Not sure how you would testify from Ah breakage respect, but I think it's going to be very informative because I think there is.
Certain lethal and effective drug who dengue fever to be able to be a first for treatment and for <unk>.
Janet Hammond: So I think it will be important in showing that we are effectively able to inhibit the development of viremia in patients who are administered the dengue virus and therefore I think it provides some element of proof of concept for treatment. But I think it also provides an element of proof of concept for prophylaxis. So I think for both those reasons, it's quite an important and intriguing study to do. And then, with regard to the dose, the phase treatment study that I outlined actually will be looking at a couple of doses, so we'll pick the dose up and determine what the best dose is. Great, thank you.
It will be important in I'm sharing of not effectively able to inhibit the development of viremia and patients who are administrator. Thank you virus and also and therefore I can provide some element of proof of concept actually in treatment, but I think it's also provides.
I'm just proof of concept four prophylax, a second birth I think for both those reasons, it's quite an important and intriguing study to do.
And then with regards to the <unk> the <unk> phase two treatment studies as I outlined actually will be looking at a couple of doses, who will take the dose.
And the bulk of this Jason.
Great. Thank you.
Janet Hammond: Thank you. Again, if anyone would like to ask a question, please press the star and then the number one key on your touchtone telephone. We have the next question comes from the line of Rwana Reese of FVB Leary. Your line is now open, and you may ask your question. Great, thanks.
Thank you again, if anyone would like to ask a question. Please.
Then the number one key on your Touchtone telephone.
The next question comes from the lineup Rwanda Reece SDB lyric. Your line is now open you May ask you a question.
Operator: Good afternoon. So, one question for your COVID program. Could you just update us a little bit on what you've learned so far with your preclinical testing of the combination use of benzophosphamivir with a protease inhibitor? And I'm also curious, have you done any testing or plan to do testing of the Omicron sub variants that are emerging right now?
Great. Thanks, Good afternoon, So uhm one for your Covid program could you just update us a little bit on what you've learned so far with your preclinical testing of combination use of them fast severe with a protease inhibitor and I'm also curious have you done any testing or plan to do testing of the omicron.
Some variance that are emerging right now.
Rwana Reese: Well, thank you for your question. Number one, we have data on going. So I think it's too early to share related to combination with some PIs. We are evaluating actually several of them, and we will share very likely. Bye.
Alright.
Thank you for your question number on.
We update on guard.
It's too early to fear related to combination with.
<unk>.
Truly.
Several of them.
And we will ship very lightly.
But.
John Pierre-Santosi: Let's say, hopefully, in the near future, when we believe that we have a critical mass of data. And, I'm sorry, the second question, Janet, if you could address the second question, please. So I think the second question was related to the same line she's on here, but there is testing for Omicron, and I think that is still in the works, and we haven't yet seen the results, but I think they're anticipated shortly. Okay, that's fair.
Let's say.
Fully in the near future.
When we believe that we have a critical mass.
Of data.
And.
And I'm sorry, the second question.
Janet.
If you can address the second question. Please.
I think the second question is really a as in 19 compared to their own testing to omnicom and I think that it's still in the works and you haven't seen the results, but I think there.
Okay.
Janet Hammond: No worries. And then I also wanted to ask you a question about your HCV program. So thinking ahead with this phase two combination trial that you're going to initiate, what types of features are you considering? Or can you just ballpark give us a sense of how big this trial might be, and what you're hoping to look for in the data in terms of results? Janet, do you want to address it? Yes, but I'm afraid it's not going to be an answer that is going to be very satisfactory because we're in the process of working that out. And so I think we'll be able to give you information a little later in the year, but that's probably not today. Okay, fair enough.
Okay. That's fair no worries and then I also wanted to ask a question about your HCV program. So thinking ahead with this phase two combination trial that you're going to initiate what types of features are you considering or can you just ballpark give us a sense of how big this trial might be what you are <unk>.
Hoping to look for in the data in terms of the results.
Janet you went through a dresser.
Yes, but I'm afraid, it's not going to be an aunt, which is going to be very satisfactory because.
The purpose of working that out and so I think we'll be able to give you information in this nation.
In us today.
Okay fair enough. Thanks again.
Okay.
Rwana Reese: Thanks again. Thank you. Thank you. I am showing no further questions at this time. I would now like to turn the conference back to its CEO, Jan-Curio Samodossi.
Thank you I am no showing I am showing no. Further question at this time I would now like to turn the conference back to U C E O John through some dusty.
John Pierre-Santosi: Thank you again for joining us and for your continued support of Atea. Thank you, ladies and gentlemen. We just conclude today's conference call. Thank you all for participating, and have a wonderful day. You may spend all day, music playing music playing [music].
Sure. Thank you again for joining us and for your continued support.
Thank you.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you all for participating and have a wonderful day you may all disconnect.
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Operator: Good afternoon, ladies and gentlemen, welcome to the Atea Pharmaceuticals Food Quadrant full year 2021 financial results 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 Ms. Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Please, Thank you, and good afternoon everyone, and welcome to Atea Pharmaceuticals' fourth quarter and full year 2021 financial results conference call.
Good afternoon, ladies and gentlemen, welcome to the <unk> Pharmaceuticals fourth quarter and full year 2021 financial results 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 MS. Jenny Barnes Senior Vice President of Investor Relations and corporate communications at I'd say, if I misheard. The coach. Please proceed.
Thank you and good afternoon, everyone and welcome to the Teva Pharmaceuticals fourth quarter and full year 2021 financial results Conference call. This afternoon, 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.
Operator: This afternoon, we issued a press release that 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 investor section of our website at www.ir.ateafarma.com. With me today from Atea are our Chief Executive Officer and Founder, Dr. John Pierre Santosni, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Vavricka. They will all be available for the Q&A portion of today's call.
All of our web site at IR Dot I tell you affirm a dot com with me today from Italia, Our Chief Executive Officer, and founder Dr. John P. R. O C Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer, and Executive Vice President of legal Andrea Corcoran, and our Chief Commercial Officer Dawn Beverly.
They will all be available for the Q&A portion of today's call.
Jonae Barnes: Before we begin the call, as outlined on slide two, I would like to remind you that today's discussion will contain forward-looking statements that involve risk 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.
Before we begin the call is 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 discuss.
On today's call with that I'll now turn the call over to John here. Thank you.
John Pierre-Santosi: With that, I'll now turn the call over to John Pierre. Thank you, Jonae. Good afternoon, everyone, and thank you for joining us today.
John Pierre-Santosi: I will begin on slide three. From the beginning, Atea's goal has been to discover breakthrough drugs against severe RNA viral diseases. Today, with the evolving nature of COVID-19, it is clear that a combination of direct-acting anti-virals will be needed to address this very challenging viral disease. What have we learned in the past year?
Good afternoon, everyone and thank you for joining us today.
I will begin on slide <unk>.
Since the beginning of third goal has been to this code Brexit drugs against Covid.
Diseases today.
With the evolving nature of COVID-19, it is clear that combination of direct acting antiviral would be needed to address this very challenging viral disease.
John Pierre-Santosi: We are dealing with a viral disease that is rapidly evolving from variant to variant within three to six months, with major pandemic searches, such as what we saw with Delta last summer and now with Omicron. We're also starting to see the significant public health and economic impact of long COVID, which will continue to have long-term effects on individuals and society as well. This virus, which is constantly and rapidly mutating, is now evading the vaccine and most of the monoclonal antibodies.
So what have we learned in the past year.
We are beginning with a viral disease, which is rapidly evolving from version to version within three to six months with major pandemic searches such as what we have seen with Delta last summer and with or Michael.
We are also starting to see the significant public health and economic impact.
Long carbon which would continue to have long term effects on individuals and society as well.
This virus, which is constantly and rapidly mutating is now if anything vaccine and most of it is.
Monoclonal antibodies.
John Pierre-Santosi: And it's clear that we urgently need several old therapeutics, with different mechanisms of action, to deal with this challenging virus. While the protease inhibitor class has recently shown good efficacy against COVID-19, historically, we have learned that this class of drugs has a low barrier to resistance with rapid development of resistance strains, especially in immunosuppressed individuals, where we can see viral replication will continue for weeks and even months. Neucleotide drugs have been the backbone of successful oral combination regimens against many severe RNA viral diseases to mitigate this resistant issue and also to enhance Africa.
And it's clear that we urgently need several all therapeutics.
With different mechanism of actions to deal with challenging Ross.
While the <unk> inhibitor class has recently shown good efficacy against COVID-19, historically, we have learned that this class of drugs as a low barrier to resistance with rapid development of resistance strength, especially in the immuno suppressed individuals.
Well, we can see viral application will continue for weeks and even months.
Nucleoside drugs have been the backbone of successful or combination regiments against many severe viral diseases to mitigate this resistance issue and also to enhance efficacy, we believe that our nucleotide Benny Faas review or <unk>.
John Pierre-Santosi: We believe that our nuclear-tight Benny Fosbevere, or 85 to Stabben, has the potential to be a preferred nuclear choice for a combination regimen with a protease inhibitor for the treatment of COVID-19. Our team has experience of leading development efforts for several combination therapies for RNA viruses over the years, and we believe that we can deliver, again, a long-term solution with a combination of benipozivir and a protease inhibitor for the treatment of COVID-19. Turning to HCV,
Five to seven has the potential to be a preferred nuc of choice for a combination regimen with the protease inhibitor for the treatment of COVID-19.
Our team.
His experience in leading developer and therefore, several combination therapies for RNA viruses over the years and we believe that we can deliver again.
Long term solution with a combination of any possible.
And to put ace inhibitor for the treatment of a property in 19.
John Pierre-Santosi: The recent introduction of Rosa's beer, combined with Benny Forzebeer, will accelerate the timeline of our HCV program and may result in the best-in-class pangenotypic hepatitis C combination regimen. However, there is still a need for improved HCV treatment with shorter treatment duration, better convenience, and elimination of revival in patients with advanced liver disease. As John will discuss later in the call, the hepatitis C market is large, and the global HCV market in 2021 is projected to approach $4 billion, whereas the US represents about 50% of the market.
Turning to HCV.
The recent in licensing of reserves.
Combined with Ben at Fosterville will accelerate the timeline of our HCV program and.
And May result in the best in class Pan Genotypic Hepatitis C combination regimen.
There is still a need for improved HCV treatment with shorter treatment duration, better convenience and to eliminate ribavirin in patients with advanced.
Liver disease.
As John will discuss later in the call. The hepatitis C market is large and the global HCV market in 2021 approach $4 billion.
With the U S Bureau of.
Presenting about 50% of the market.
John Pierre-Santosi: We are also advancing our third clinical program, AT752, a nucleotide analog generated from our Purein platform. Dengue fever is the most prevalent mosquito-borne viral disease with a large global disease burden and a lack of antiviral treatment. We successfully completed the Phase 1 study late last year, and 87.52 will now progress to a Phase 2 clinical trial conducted in dengue-endemic countries, as well as a challenge study conducted in the U.S. Let's now review our strategy for COVID-19. Moving to slide five.
We are also advancing our third clinical program <unk> seven phase II, a nucleoside analog generated from our Purion platform.
Thank you fever is the most prevalent mosquito borne virus disease with a large global disease burden and lack of <unk> treatments.
We have successfully completed the phase one study late last year and 80 752 will now progressed to a phase II clinical trial conducting in dengue endemic countries as well as a challenge study conducted in the U S.
Let's now review.
Our strategy for COVID-19.
Moving to slide five.
John Pierre-Santosi: Our vision for Benifaz-Rivera is to be a nuke of choice, as I've said, for the combination treatment with a protease inhibitor for COVID-19. Benny Fossbier, Targeted Viral RNA Polymerase, which, as you may know, is a highly conservative design, critical to the biopication and the transcription of this world. Uniquely.
Our vision.
Well Benny positive here is to be a nuc of choices outside for the combination treatment with a protease inhibitor for COVID-19.
Benny Fosterville target the viral RNA polymerase.
Which as you may know is a highly conserve enzyme critical to the viral replication and the transcription of these raws.
Uniquely.
John Pierre-Santosi: Benny Fozbevi has a mechanism of action, or MOA, with dual targets. It is both a chain terminator and without introducing, Any Invitations? A new mutation in the volcano, especially in the spike protein, as I've been shown with, It is also inhibiting the near end function, which is also a functional function of the RNA polymerase, and which is also critical to the biomarky case. Thus we believe that this MOA provides the potential to create a high barrier to resistance, as well as provide anti-viral activity across any variants of concern.
Many positive he has a mechanism of faction of MAA with dual targets.
It is both a chain terminated.
Without introducing.
Any mutation.
A new mutation in the Volte Gino, especially in the spike protein that has been shown with montefiore.
It is also inhibiting the <unk> function, which is also a functional function of the iron They put anyways and which is also critical to the viral replication.
Thus, we believe that this provides the potential to create a high barrier to resistance as well as provide anti viral activity across any variance of concern.
John Pierre-Santosi: Details relating to this MOA were recently published in the peer-reviewed journal Nature Communications. So, based on this unique MOA, we can anticipate that Benifaz-Vivir will maintain its activity as this virus continues to evolve in all clinical studies today. Benefits were shown to be generally safe and were tolerated.
And details.
Relating to this MRI were recently published in the peer reviewed journal nature Communications.
So based on this unique MRI.
We anticipate that <unk> will maintain its activity.
As this virus continues to evolve.
In all clinical studies to date <unk> was shown to be generally safe and well tolerated.
John Pierre-Santosi: Of note, it is non-mitogenic, with no reproductive toxicity, and is non-teratogenic. And it is the safety profile that I believe makes Benifazbevir uniquely well suited, not only for combination treatment regimens in COVID-19, but also for HCV, which we'll review during this presentation. I will now end the call over to Janet. Thank you, Jean-Pierre. Good afternoon, everyone.
Note it is non mutagenic.
There was no reproductive toxicity and is not there with the agenda.
And it is this safety profile, which believe that makes many forces reveal uniquely well suited not only for combination treatment regimen in COVID-19, but also for HCV, which we view.
During this presentation.
I will now end the call over to Jan.
Janet Hammond: Let's turn to slide six. Advancing benefits for COVID-19 remains a top priority for us. Combination therapy using multiple drugs for different mechanisms of action, is important to limit the development of resistance for many RNA viral diseases such as HCV and HRI. We're working diligently on our COVID-19 clinical development program, taking into account the continuously evolving COVID-19 landscape, and we look forward to sharing with you further information on this plan in the future. This group type is C, and I'm going to hand the call over to Josh.
Thank you John Good afternoon, everyone Nextgen slide.
Advancing benefit could be.
Okay, 19 remains a top priority for us.
Nation, Turkey, using multiple drugs with different mechanisms of action has proven important to join the team has developed resistance will mainly R&D balance.
Such as HCV and HIV.
We're working diligently on all COVID-19 clinical development program, taking into account the continuously evolving COVID-19 landscape.
And we look forward to sharing with you.
Information on this plan in the future.
Next question.
And I'm going to hand, the call over to Josh.
Yes.
John Vavricka: Thank you, Janet. Good afternoon. Let's turn to slide eight.
Thank you Chad good afternoon, let's turn to slide eight.
Yes.
John Vavricka: The market for hepatitis C is large, with the 2021 global HCV market approaching $4 billion, with the U.S. representing approximately 50% of the market. This market size was achieved even during the height of the COVID pandemic. Although the availability of direct acting anti-viral oral combination regimens for the treatment of HCD, there remains a large, underserved HCD patient population, which continues to grow in the United States. A large portion of this increase in incidence is attributed to the opioid crisis, IV drug use, and HCV reinfection, especially among younger adults.
The market for hepatitis C is large with 2021 global HCV market approaching $4 billion with the U S representing approximately 50% of the market.
This market size was achieved even during the height of the Covid pandemic.
Despite the availability of direct acting anti viral combination regimens for the treatment of HCV. There remains a large underserved HCV patient population, which continues to grow in the United States.
A large portion of this increase in incidence is attributed to the opioid crisis IV drug use and HCV reinfection, especially among younger adults.
John Vavricka: We believe that a new, best-in-class, pan-geontific HCV regimen that has a shorter treatment duration and is more convenient has the potential to achieve blockbuster status. Additionally, a more potent nucleotide-based regimen should eliminate the need for ribavirin in patients with decompensated serotonin. I'll now hand the call back to Janet. Thanks, John. Moving to Slide 9, we're very pleased to have secured an exclusive worldwide license from Merck to develop a brand new manufacturer and commercialized reserve, an oral NSI day in Hibiscus. We're excited about Roosevelt's profile.
We believe that a new best in class Pan Genotypic HCV regimen that has a shorter treatment duration and is more convenient.
Has the potential to achieve blockbuster status.
Additionally, a more potent nucleotide based regimen should eliminate the need for ribavirin in patients with compensated cirrhosis.
Ill hand, the call back to Josh.
Thanks, John moving to slide nine.
We have obtained an exclusive worldwide license from back to Japan, the manufacture and commercialize reason there.
Earl.
Davidson.
Janet Hammond: It is one of the most potent NS5A inhibitors, with NV proactivity in the PicoMolar range against all seven HCV genotypes. Assumptive clinical studies of Rusev's Bay conducted by Merck showed potent antiviral activity in HCV-infected patients. In over 1,200 patients at daily doses of up to 180 mg for up to 24 weeks, a favorable safety profile with no consistent treatment-related changes in laboratory parameters was observed, and this further supports the combination of Benny Foster there and Rooza their impatience.
We're excited about recent sales profile.
It is one of the most potent <unk> inhibitors with in vitro activity in the Picomolar range against all seven HCV genotype.
Extensive clinical studies of <unk> conducted by Merck.
<unk> antiviral activity in HCV infected patients.
The 1200 patients daily doses of up to 180 milligram 24 weeks and favorable safety profile with no consistent treatment related changes in laboratory parameters was observed.
To further support the combination of Benny Foster that an <unk> patient we've conducted in vitro experiments either here or in combination.
Janet Hammond: We've conducted in vitro experiments either alone or in combination. As shown in the figure on this slide, these experiments demonstrate that the combination resulted in substantially greater inhibition of HCV replication than either agent alone, suggesting a significantly synergistic antiviral effect between the two inhibitors. Once again, a key reason why we in-licensed Roosevelt was its advanced development stage, which decreases development risks and also provides the opportunity to create a best-in-class pan-genotypic combination therapy with benifosporiac in a shorter time frame.
As shown in the figure on the slide these experiments demonstrating that the combination resulted in substantially greater inhibition of HBV replication than either agent alone.
Suggesting a significantly synergistic antiviral effect between the two inhibitor.
Once again, a key reason why we ended up.
That wasn't the advanced development stage, which decreases development risks and also provides the opportunity to create best in class Pan Genotypic combination therapy with <unk> in a shorter timeframe.
Janet Hammond: Now let's move to Benny Fosterville's profile in HCV, which is shown on slide 10. Ben Prosper, who was the primary focus of Atea's original program before COVID hit, is about tenfold more potent than Fifosfavir in vitro against a panel of laboratory strains and clinical isotopes, and remains fully active against the post-severe resistance strain. In monotherapy, Benifastivir demonstrated a potent response, and uniquely, viral kinetics were consistent across all genotypes, including genotype 3, as well as in patients with compensated cirrhosis. As you can see in the chart, there is a rapid and steep decline of around four logs within 72 hours.
Now, let us move today from Suzanne profiling, HDD, which is shown on slide 10.
Danny Coster with primary focus of the original program before Covid hit.
It's about 10 fold more potent than to foster that in vitro against the timing of the Barclay stringent clinical estimate Andrew.
And we remain fully active again.
And strange.
In monotherapy Fannie fast because they are demonstrating the patent expense and unique T. Viral kinetics are consistent across all genotypes, including genotype three as long as in patients with compensated cirrhosis.
As you can see in the chart there was a rapid and steep decline of around fallouts within 72 hours.
Janet Hammond: This rapid and steep decline is important to prevent the potential for the development of NSIVA resistance, especially in the hard-to-treat Genotype 3 population. Benifospovir at 550 mg supports once-daily dosing, and based on its safety, tolerability, and efficacy profile to date, it's an ideal candidate to develop in combination with rizuzin. Moving to side 11.
This rapid and steep decline it's important to prevent the potential development of NSV resistance, especially in the hard to treat genotype <unk> population.
<unk> hundred 60 milligram supports once daily dosing.
Any kind of safety tolerability and efficacy profile to date.
Ideal candidates developed in combination with <unk>.
Moving to slide 11.
Janet Hammond: [inaudible] We're very excited about our HCV combination development plan and believe that there is still room to improve on the standard of care. Significant data has been generated for birth drug candidates. And as soon as synthesis has been completed for the reason for their clinical trial material, we will move quickly into a phase examination study. We anticipate initiating the study in the second half of the year. Our Phase II Development Program will evaluate treatments of shorter duration and will include patients with both compensated and decompensated liver disease.
Very excited about our HCV combination development path and believe that there is still room to improve on the standard of care.
A significant data is being generated prepared drug candidates and as soon as synthesis has been consistent for the reasons that clinical trial materials.
We will move quickly into a phase two nation study we.
We anticipate initiating the study in the second half of the year.
Our phase II development program will evaluate treatments of shorter duration and will include patients with both compensation and de compensated differently.
Janet Hammond: Let's now move to our third stage 2 program for dengue fever, and I'll hand the call over to John. Thanks, Janet. Dengue is the most prevalent mosquito-borne viral disease, and it affects almost 400 million individuals on a yearly basis.
Next I'll move to offset to prove for dengue fever, and I'll hand, the call over to Chuck.
Thanks Shannon.
Thank you is the most prevalent mosquito borne viral disease and affects almost 400 million individuals on a yearly basis.
John Vavricka: Thank you for joining us. There is a significant unmet medical need, and the global economic burden is estimated to be between $8 and $9 billion. There are no treatments for dengue, and the approved vaccine has a less than optimal profile with safety concerns and a restricted label.
Thank you the endemic in over 100 countries and greater than half the world's population of at risk.
There is a significant unmet medical need and the global economic burden is estimated to be between $8 million to $9 million.
There are no treatments for dengue.
The approved vaccine is less than it has lessened an optimal profile with safety concerns and a restricted label a breakthrough drug candidate ATI 700, <unk> two is a purion nucleotide prodrug derive from our platform.
John Vavricka: Our breakthrough drug candidate, Atea 752, is a purine nucleotide pro-drone derived from our. It has shown potent in vitro activity against all serotypes tested and demonstrated strong efficacy in animal models. I'll now hand the call back to Janet to review our program. Janet?
It has shown potent in vitro activity against all serotypes tested and demonstrated strong efficacy in the animal model.
I'll now hand, the call back to Jack to review our program Janet.
Janet Hammond: Thank you, John. As shown on slide 14, last year, we initiated and successfully completed a randomized, double-blind, placebo-controlled, single and multiple ascending dose phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of AT752 in healthy subjects. In the face-to-face trial, Atea 752 was well tolerated in 65 healthy subjects who administered either single or twice daily. There were no serious adverse events reported, and most adverse events were considered mild, and there were no changes in laboratory parameters.
Thank you John .
Shown on slide 14 last year, we initiated and successfully completed a randomized double blind placebo controlled single and multiple ascending dose phase one study to evaluate the safety cargo ability in pharmacokinetics of 80 752 in healthy subjects.
In the phase <unk> trial, 87, <unk> was well tolerated in 65 healthy subjects, who administered either single or multiple doses.
No serious adverse events reported and no.
Most adverse events were considered mild and there were no changes in laboratory parameters.
Janet Hammond: In addition to the clinical work, we also published the Portive In vitro and In Viva data of Ate 752 in Clareview, Jonae. The date of publication in Antimicrobial Agents in Chemotherapy Therapy showed that AT752 has potent in vitro activity against all dengue virus serotypes and also other plague viruses.
In addition to the clinical work. We also published portion of in vitro and in vivo data of 87 five to impair your John .
The data published in the antimicrobial agents and chemotherapy.
Showed that 80 752 has personally in vitro activity against all dengue virus Eric Katz.
And also other thank these are suggestions hec.
Janet Hammond: 8752 was also shown to reduce viremia and improve animal health and survival in a mouse model of dengue virus. In addition, data demonstrating the in vivo efficacy of AT752 against yellow fever virus were recently published in the peer-reviewed journal Costs Neglected Tropical Diseases. The published data showed that AT752 reduced viremia and improved disease outcomes in a hamster model of yellow fever virus.
<unk> was also shown to produce viremia and improve animal health and survival in a mouse model of dengue bar.
In addition.
Demonstrating the in vivo efficacy of <unk> preference is to again D&O fever virus was recently published in the peer reviewed journal costs neglected tropical diseases.
The published data showed that 80, 752 reduced viremia and improve disease outcomes in a hamster model of entities as ours.
Janet Hammond: There are two key studies that we are planning to conduct in 2022 for the Dengue Probe. On slide 15 is the first study, which is a human challenge study we're counting in the United States. In this study, healthy volunteers are dosed with 8752 or Persever and then administered a live dose of Dengue. Subjects are closely monitored within a highly controlled setting, allowing the assessment of viral load and the viral kinetics to be compared between treatments.
There are two key studies that we are planning to conduct in 2022 for the dengue program on Slide 15 is the first study which is the human challenge study, we're counting in the United States.
In this study healthy volunteers are dosed with <unk>, two or placebo and then administered in light.
Of dengue virus.
Subject to <unk> within a highly controlled setting, allowing the assessment of viral load and the viral kinetics to be compared between treatment groups.
Janet Hammond: Results are expected in the second half of the year. Pictured on slide 16 is the second key study we plan to initiate during the first half of this year. This is a phase to proof-of-concept treatment study in patients with dengue fever, and this study will be conducted in dengue endemic countries around the world. This study is designed to assess antiviral activity, safety, and pharmacokinetics of multiple doses of A275-2, with a primary endpoint of change from baseline in viral load. 8752 or placebo will be administered orally for five days in patients with dengue infection who present within 48 hours of developing a fever.
<unk> are expected in the second half Cynthia.
Pictured on slide 16 is the second key study we plan to initiate during the first half of this year.
It is a phase two proof of concept treatment study in patients with dengue fever.
And this study will be conducted in Jamie dengue endemic countries around the world.
The study is designed to assist the antiviral activity safety and pharmacokinetics of multiple doses of 87 two.
With a primary endpoint of change from baseline and boundaries.
87, <unk> to placebo will be administered orally for five days in patients with dengue infection, who present within 48 hours of developing fever.
Janet Hammond: The study will be initiated soon, with initial results anticipated late in 2022. I'm going to hand the call over now to Andrea so she can review our financial information. Thank you, Janet. As Jonae mentioned in her introductory remarks this afternoon, we issued a press release containing our financial results for the fourth quarter and full year of 2021. For the fourth quarter of 2021, the increase in R&D expenses in comparison to the fourth quarter of 2020 was principally driven by an increase in external clinical development and manufacturing expenses incurred primarily in conjunction with the development of the AT-527 for the treatment of COVID-19 and, to a lesser extent, AT-752, which is being developed for dengue fever. We also had an increase in internal spend, primarily attributable to an increase in Atea personnel-related expenses.
The study will be initiated soon with initial results anticipated later in 2022.
And then hand, the call over now to <unk> to review our financial information.
Andrea Corcoran: Of note, our external expenses include our share of costs incurred by Roche relating to the beneficiaries of Phase 2 Moonsong, Phase 3 Morning Sky, and Phase 3 Meadowspring Clinical Trials. These shared costs include external costs incurred by Roche in connection with the conduct of the studies and FTE costs for Roche personnel who are working on this program. The increase in G&A expenses quarter-over-quarter was primarily due to an expansion of our organization and consisted principally of an increase in payroll and personnel-related expenses.
Thank you gentlemen.
As Tony mentioned in her introductory remarks afternoon, we issued a press release containing our financial results for the fourth quarter and full year of 2021.
Statement of operations and balance sheet can be found on slide number 18 and 19.
For the fourth quarter 2021, the increase in R&D expenses in comparison to the fourth quarter of 2020 was principally driven by an increase in external clinical development and manufacturing expenses.
Primarily in conjunction with the development of the 85 to seven for the treatment of COVID-19, and to a lesser extent 80, 752, which is being developed for dengue fever.
We also had an increase in internal spend primarily attributable to an increase in personnel related expenses.
Of note our external expenses include our share of costs incurred by Roche relating to <unk>, our phase two Moon song Phase III morning, Sky and phase through metal spring clinical trials.
<unk> costs include external costs incurred by Roche in connection with the conduct of the studies and FTE cost for Roche personnel, who are working on this program.
The increase in G&A expenses quarter over quarter was primarily due to an expansion of our organization and consists principally and an increase in payroll and personnel related expenses.
Andrea Corcoran: I am pleased to report that we ended the year with a strong balance sheet to support our clinical development programs. As of December 31, 2021, cash and cash equivalents amounted to $764.4 million. For financial guidance going forward, please note that during the first quarter of 2022, we expect to incur residual costs from Roche associated with the winding down and closure of the Moonsong, Morning Sky, and Meadowspring trials. The timing of R&D expenses in 2022 is currently expected to be back and loaded.
I am pleased to report that we ended the year with a strong balance sheet to support our clinical development programs as of December 31, 2021, cash and cash equivalents amounted to $764 $4 million.
For financial guidance going forward. Please note.
During the first quarter of 2022, we expect to incur residual costs from Roche associated with the wind down and close out of the mood swung morningside and metal spring trials.
The timing of R&D expenses in 2022 is currently expected to be back end loaded. This assumption is driven by clinical plans, which currently contemplates the initiation of the phase III <unk> trial as Jeff just described and the challenge study during the first half of the year as well as initiation.
Andrea Corcoran: This assumption is driven by clinical plans, which currently contemplate the initiation of the Phase 2 Dengue trial, as Janet just discussed, and the challenge study during the first half of the year, as well as the initiation during the second half of the year of the Phase 2 Benifacivir combination trial for COVID-19 and the initiation of the Phase 2 combination trial of Benifacivir and Mucivir for HCV, which will likely be later in the year For spending going forward, we will be taking a disciplined, biotech-focused approach.
During the second half of the year of the phase III <unk> pass severe combination trial for COVID-19, and initiation of the phase II combination trial any thoughts for the year and re severe for HCV, which will likely be later in the year.
For spending going forward, we will be taking a disciplined biotech focused approach as previously mentioned expenses in 2021 included cost sharing with Roche relating to external spend associated with moves on good morning, Sky and metal spread COVID-19, clinical trials and Roche FTE involved.
Andrea Corcoran: As previously mentioned, expenses in 2021 included cost sharing with Roche relating to external spend associated with Moonsong, Morning Sky, and Meadowspring COVID-19 clinical trials and Roche FTEs involved in the COVID-19 program, which was a big pharma model.
The COVID-19 program, which was a big pharma model.
John Pierre-Santosi: We anticipate having cash runways through 2025, and we plan to be very dilution sensitive as we move forward. I'll now turn the call back over to Jean-Pierre for closing remarks. Thank you, Andrea. In closing, we are building a pipeline with the vision to be a leading anti-viral company. We plan to continue to build out our pipeline of antiviral product candidates by broadening our nucleotide pipeline with other classes of antivirals that may be used in combination with our nucleotide product candidates.
We anticipate to have cash runway through 2025, and we plan to be very dilution sensitive as we move forward.
I'll now turn the call back over to jump here for closing remarks. Thank.
Thank you Andrea.
In closing we.
We are building a pipeline with the vision to be a leading <unk> company.
We plan to continue to build out our pipeline of antiviral product candidates by broadening our nuclear science pipeline with other classes of <unk> that may be used in combination with our nucleoside product candidate.
John Pierre-Santosi: In 2022, we expect to make meeting full progress across our three phase two program for COVID-19, HCV, and Dane. These programs have the potential to provide global solutions, for Patients Suffering from Severe Viral Diseases. The data set for these clinical trials will be important readouts, and should be key inflection points for our company. Importantly, as Andrea has indicated and presented. We have the financial strength with a catch runway through 2025 and a seasoned management team to advance this program. As always.
In 2022, we expect to make meaningful progress across our three phase III program for COVID-19, HCV and thank you.
These programs have the potential to provide global solutions.
Patients suffering from severe of all diseases.
The data set for these clinical trials will be important readouts.
Key inflection points for our company.
Importantly.
Some drag as indicated and presented.
We have the financial strength with a cash runway through 2025, and the seasoned management team to advance these programs.
As always we.
John Pierre-Santosi: We thank you for your continuous support as we build Atea into a global leader in the discovery, development, and commercialization of oral therapies that address the unmet medical needs of patients with severe bowel disease. With that, Operator, we will now open the call to your questions. Thank you. Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the hash tag.
Thank you for your continued support as we built through a global leader.
And the discovery development and commercialization of all therapies.
Addressing unmet medical needs of patients with severe viral diseases.
With that.
We will now open the call up to your questions.
Thank you ladies and gentlemen, if you have a question at this time. Please press the star and then the number one key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the hash key.
Operator: We have the first question comes on the line from Matthew Harrison of Morton Spanley. Your line is now open; you may ask your question. Great, thanks for taking the questions. Good afternoon. I guess two for me.
We have the first question comes from the line of Matthew Harrison of Morgan Stanley . Your line is now open you may ask your question.
Matthew Harrison: So first, when you're thinking about potential combination partners in COVID, you know, what do you think you need in terms of an agreement here? I mean, are there, do they, I don't know, just give me some sense in terms of how you get access to the drug and how you might think about those studies. Do you need a formal agreement or could you get access otherwise?
Great. Thanks for taking the questions. Good afternoon, I guess two for me so first when youre thinking about potential combination partners in Covid.
What do you think you need in terms of an agreement here I mean are there do they I don't know just give me some sense in terms of how you get access to drug and how you might think about those studies do you need a formal agreement or could.
Matthew Harrison: And then second, on dengue, just give us a sense of what sort of, I guess, clinical outcome here would be meaningful in these patients. Is it about duration of disease, you know, symptoms, et cetera? Thanks very much. Thank you, Matt, for your questions. Related to the first question, we are open to partnership, but at the same time, as you have seen earlier, we are going to be very opportunistic to evaluate externally as we are doing right now internally in terms of PI for COVID.
Because you've got access otherwise.
And then second on dengue.
Just give us a sense of what sort of I guess clinical outcome here would be meaningful in these patients is it about duration of disease.
Symptoms et cetera, thanks very much.
Thank you Matt for your questions related to the first question.
We are open to partnership.
But in the same time.
Yes.
We are going to be very opportunistic.
Two.
Evaluate externally.
Matthew Harrison: So, as we speak, we are evaluating several opportunities, and I will foresee preferably in licensing rather than in partnership, but we are definitely open to potential interaction with some of the players with maybe more advanced PI.
We are doing right now internally in term of Pi for carbon.
So as we speak.
Evaluating several opportunities.
And I would foresee preferably in licensing rather than the partnership but we are definitely open to.
<unk>.
Potential.
Interaction with some of the players.
Maybe more advanced beyond if we believe that.
They're busy.
Two a potential best in class and compare was the evaluation that we're doing right now.
John Pierre-Santosi: If we believe that they lead to potential best in class and compare them with the evaluation that we are doing right now in virtual studies. Related to the second question, I'll let Janet address the second question, Janet. Thanks, Jean-Pierre. So I think we have two studies, as I mentioned, a challenge study and a treatment study. So in the challenge study, really, it's a pergolaxis model. So what we're going to be looking for is the absence of the development of viremia in patients who have been pre-administered AT752. In the treatment study, patients who already have symptoms will be looking for reduction in viremia and also the prevention of progression to more severe dengue in these patients and reduction in symptoms.
In vitro hours in vitro studies related to the second question.
I'll, let jana to address the second question Shannon.
Thanks, Tom.
Thank you we have two studies as I mentioned the challenge study under treatment studies in the challenge study.
This model to work against you be looking for.
The absence of the development of viremia in patients who have been created 87 sites.
In the treatment study.
Good questions that were already have symptoms and will be looking for reductions in viremia and also the prevention of progression to more severe dengue on these patients and reduction.
Thank you.
Yeah.
Janet Hammond: Thank you. Thank you. We have the next question comes from the line of Mr. Tim Lugo from William Blair. Your line is now open. You may ask, "Hey, this is Lachlan."
Thank you we had the next question comes from the line of Mr. Tim Lugo with William Blair. Your line is now open you may ask your question.
Operator: I'm for Tim. Thanks for taking the question. A couple on the Dengue program. How do you see the challenge study fitting into a regulatory process? Do you see that as a Phase 2 or more of a way of informing your plans for a Phase 2? And second of all, after the Phase 1 data, have you sort of narrowed down on a dose or multiple doses and dose regimens you plan to evaluate in the Phase 2s for Dengue? Janet?
Hey, this is lachlan on for Tim Thanks for that.
A couple on the dengue program.
How do you see the challenge study.
A regulatory process do you see that as a phase two or more.
Informing your plans for a phase III.
And second of all after the phase one data have you sort of narrowed down to a dose or multiple doses and dose regimens you plan to evaluate in the phase III sadangi.
Janet.
Tim Lugo: So I think we would consider the study probably to be somewhat of a hybrid, the challenge study, as these are healthy volunteers who are being administered a challenge dose. So I'm not sure how you would classify it from a regulatory perspective, but I think it's going to be very informative because I think there is certainly scope for an effective drug for dengue fever to be able to be used both for treatment and for prophylaxis.
So thank you Tim.
So.
Think we would consider this study probably to be somewhat of a hybrid Z. The challenge study as these are healthy volunteers.
Who are being administered.
Challenged.
I'm not sure how you would classify it from a rate perspective, but I think it's going to be very informative because I think there is scope certain lethal effect to Scott. Thank you for you to be able to be your first full treatment and for <unk> I think it will be important.
Janet Hammond: So I think it will be important in showing that we are effectively able to inhibit the development of viremia in patients who are administered the dengue virus, and therefore, I think it provides some element of proof of concept for treatment. But I think it also provides an element of proof of concept for prophylaxis. So I think for both those reasons, it's quite an important and intriguing study to do. And then, with regard to dose, the Phase 2 treatment study that I outlined actually will be looking at a couple of doses.
I am showing that we are effectively able to inhibit their development of viremia in patients who are administered there. Thank you Barbara and so.
I can provide some element of proof of concept actually in treatment, but I think it also provides an element of proof of concept for prophylaxis secondary I think compared to those recent question important and intriguing study to do.
Janet Hammond: So we'll pick up the dose and determine what the best dose is. Good, thank you. Thank you. Again, if anyone would like to ask a question, please press the star and then the number one key on your touchtone telephone. We have the next question comes from the line of Rwana Rees of SVB Lyrics. Your line is now open, and you may ask your question. Great. Thanks. Good afternoon.
And with regards to the phase two treatment study that I outlined actually we'll be looking at a couple of doses that will pick the dose and determine welcome. Thanks Jason.
Great. Thank you.
Thank you again, if anyone would like to ask a question. Please press the star and then the number one key on your Touchtone telephone.
We have the next question comes from the line of Rwanda lease of SDB Leerink. Your line is now open you may ask your question.
Operator: So, um, one for your COVID program, could you just update us a little bit on what you've learned so far with your pre-clinical testing of combination use of them to foster severe with a proteate inhibitor? And I'm also curious, have you done any testing or plan to do testing of the Omicron sub variants that are emerging right now? Thank you for your question. Number one, we have data ongoing. So I think it's too early to share information related to combination with some PIs.
Great. Thanks, Good afternoon. So one for your Covid program could you just update us a little bit on what you've learned so far with your preclinical testing of combination use of them DFAST severe with our protease inhibitor <unk>.
Im also curious have you done any testing or plan to do testing of the omicron sub variants that are emerging right now.
Operator: We are evaluating actually several of them, and we will share very likely by, Let's say, hopefully in the near future, when we believe that we have a critical mass of data. And, I'm sorry, the second question, Janet, if you could address the second question, please. I think the second question was really along the same lines, but there is testing for Omicron, and I think that is still in the works, and we haven't yet seen the results, but I think they're anticipated shortly.
Right.
Thank you for your question number one.
We have data on growing.
I think it's too early to share related to combination with <unk>.
So we are evaluating actually.
Several of them.
And we will share a very likely.
Bye.
Let's say in the hopefully in the near future.
When we believe that we have a critical mass of data.
And I'm sorry, the second question.
Janet.
If you can address the second question. Please.
Second question was rated on the same 90 compared to their own testing for Amit and.
And I think that is still in the works and we haven't yet seen the results, but I think their anticipated shortly.
Rwana Reese: Okay, that's fair. No worries. And then I also wanted to ask a question about your HCV program. So thinking ahead with this phase two combination trial that you're going to initiate, what types of features are you considering? Or can you just ballpark give us a sense of how big this trial might be, and what you're hoping to look for in the data in terms of results?
Okay. That's fair and then I also wanted to ask a question about your HCV program. So thinking ahead with this phase two combination trial that you're going to initiate what types of features are you considering or can you just ballpark give us a sense of how big this trial might be what.
You are hoping to look for in the data in terms of the results.
Janet Hammond: Janet, do you want to address it? Yes, but I'm afraid it's not going to be an answer that is going to be very satisfactory because we're in the process of working that out. And so I think we'll be able to give you information a little later on in the day that's probably not today. Okay, fair enough.
Janet do you want to address it.
Okay.
It's not going to be an answer which is going to be very satisfactory because we're in.
The process of working that out and so I think we'll be able to give you information on this later in the Opex.
That's probably not today.
Rwana Reese: Thanks again. Thank you. I am no showing on.
Okay fair enough. Thanks again.
Thank you.
Operator: I am showing no further questions at this time. I would now like to turn the conference back to. Thank you again for joining us and for your continued support of Atea. Thank you. Thank you, ladies and gentlemen, this concludes today's conference call. Thank you all for participating and have a wonderful day. You may all disconnect.
Thank you I am no showing I am showing no further question at this time I would now like to turn the conference back to CEO , John threw some of Dusty.
Sir Thank you again for joining us and for your continued support of <unk>.
Thank you.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you all for participating and have a wonderful day you may all disconnect.