Q2 2024 Atea Pharmaceuticals Inc Earnings Call

August 7, 2024

Speaker Change: Good afternoon, everyone, and welcome to Atea's Pharmaceutical Second Quarter 2024 Financial Results and Business Update Conference Call.

Speaker Change: At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions.

Jonae Barnes: I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Ms. Barnes, please proceed.

Jonae Barnes: Thank you. Good afternoon, everyone, and welcome to Atea Pharmaceutical's second quarter 2024 Financial Results and Business Update conference call. Earlier today, 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 Somidosi, Dr. Aransha Horga, Chief Medical Officer, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Vavricka.

Jonae Barnes: Thank you. Good afternoon, everyone, and welcome to Atea Pharmaceutical's second quarter 2024 Financial Results and Business Update conference call. Earlier today, 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 Somodosy, Dr. Aransha Horga, Chief Medical Officer, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Vavricka.

Speaker Change: Thank you. Good afternoon, everyone, and welcome to Atea Pharmaceutical's second quarter 2024 financial results and business update conference call.

Speaker Change: Earlier today, we issued a press release which outlines the topics we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by going to the investor section of our website at ir.ateapharma.com.

Speaker Change: With me today from Atea are our Chief Executive Officer and Founder Dr. John Pierre Somidosi, Dr. Aranja Horga, Chief Medical Officer,

Speaker Change: 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.

Jonae Barnes: They will all be available for the Q&A portion of today's call. Before we begin the call, and as outlined on slide two, I would like to remind you that today's discussion will contain forward-looking statements that involve risk and uncertainty. 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 the call today. With that, I'll now turn the call over to John Pierre.

Speaker Change: Before we begin the call, and as outlined on slide 2, I would like to remind you that today's discussion will contain forward-looking statements that involve risk and uncertainty.

Speaker Change: 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 the call today. With that, I'll now turn the call over to Jean-Pierre.

John Pierre Somodosy: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us.

John Pierre Somidosi: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us.

John Pierre Somodosy: The first half of 2024 was marked by strong operational execution and significant clinical progress. We completed patient enrollment in both the Global Phase III, Sunrise III study of Benifazivir for the treatment of COVID-19 and the Global Phase II study, which evaluated a combination of Benifazivir and Rizivir in treatment-naive HCV-infected patients. As you know, COVID is now in them, and as new variants continue to evolve, they are likely to continue to cause recurrent surges of cases. Following the winter surge of infections caused by the variant JN1, we are now experiencing a summer wave across the U.S., Europe, and global locations, largely driven by new Kp and Lb1 variants.

John Pierre Somidosi: The first half of 2024 was marked by strong operational execution and significant clinical progress. As you know, COVID is now in them. Following the winter surge of infections caused by the variant JN1, we are now experiencing a summer wave across the U.S., Europe, and global locations, largely driven by new Kp and Lb1 variants.

Jean-Pierre: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us.

Jean-Pierre: The first half of 2024 was marked by strong operational execution and significant clinical progress.

Jean-Pierre: We completed patient enrollment in both the Global Phase 3, Sunrise 3 study of Benifazivir for the treatment of COVID-19 and the Global Phase 2 study, evaluating the combination of Benifazivir and Risvir in treatment-naive HCV-infected patients.

Jean-Pierre: As you know, COVID is now endemic, and as new variants continue to evolve, they are likely to continue to cause recurring surges of cases.

Jean-Pierre: Following the winter surge of infections caused by the variant JN1, we are now experiencing a summer wave across the U.S., Europe , and global locations, largely driven by new Kp and Lb1 variants.

John Pierre Somodosy: There is a continued unmet need for suitable therapies leaving the most vulnerable people at risk for severe outcomes from infection, such as the elderly, immunocompromised, and those with underlying risk factors. We look forward to potentially delivering Benifazvir to millions of patients, and we expect to report results from Sunrise 3 in the second half of 2024. Turning now to our Phase 2 program for HCV. In June, at EASL, we showcased a potential best-in-class profile of Benifazivir and Rizazivir and the promise of this combination to address the unmet needs of today's HCV patients. The demographic of HCV patients has changed over time, and today, patients take multiple concomitant medications. And those at the highest risk for HCV are also likely to be poorly adherent to their medication.

Jean-Pierre: There is a continued unmet need for suitable therapies leaving the most vulnerable people at risk for severe outcomes from infection, such as the elderly, immunocompromised, and those with underlying risk factors.

John Pierre Somidosi: We look forward to potentially delivering Benifazvir to millions of patients, and we expect to report results from Sunrise 3 in the second half of 2024. In June, at EASL, we showcased a potential best-in-class profile of benifozbivir and risosvir and the promise of this combination to address the unmet needs of today's HCV patients. We look forward to reporting the full results from our ongoing Phase 2 study during the fourth quarter of this year.

Speaker Change: We look forward to potentially delivering Benifazvir to millions of patients and we expect to report results from Sunrise 3 in the second half of 2024.

Speaker Change: Turning now to our Phase II program for HCV.

Speaker Change: In June, at ESL, we showcase a potential best-in-class profile of Benifaz-Bevir and Rizazvir and the promise of this combination to address the unmet needs of today's HCV patients.

Speaker Change: The demographic of HCV patients has changed over time.

Speaker Change: Today patients take multiple concomitant medication.

Speaker Change: And those at the highest risk for HCV are also likely to be poorly adherent with their medications.

John Pierre Somodosy: We believe that our combination, with the low risk of drug-drug interactions combined with a short treatment duration, has the potential to address this unmanaged... We look forward to reporting the full results from our ongoing Phase II study during the fourth quarter of this year. We are currently preparing for the initiation of the Phase III program. I am pleased to report today that we have selected a fixed-dose combination tablet that achieves comparable drug exposure to individually administered beniphazivir and rizospirazine.

Speaker Change: We believe that our combination with the low risk of drug-drug interactions combined with a short treatment duration has the potential to address these unmet needs.

Speaker Change: We look forward to reporting the full results from our ongoing Phase 2 study during the fourth quarter of this year.

John Pierre Somidosi: We are currently preparing for the initiation of the Phase III program. This new tablet allows us to decrease the daily pill burden from four tablets to two, which is more convenient, obviously, for the patient. Lastly, with $502 million of cash, cash equivalents, and marketable securities at June 30, we are in a strong financial position to execute our strategy, and we anticipate our runway will extend into 2027.

John Pierre Somodosy: This new tablet allows us to decrease the daily pill burden from four tablets to two, which is more convenient, obviously, for the patient. This new tablet will be used in the Phase III program, as well as for subsequent commercialization. And Irensa will review the data in detail for you. Lastly, with $502 million of cash, cash equivalents, and marketable securities at June 30, We are in a strong financial position to execute our strategy, and we anticipate our runway will be extended in 2027. With that, I will now turn the call over to Irensa for an update on our Global Phase II HCV Program.

Speaker Change: We are currently preparing for the initiation of the Phase III program.

Speaker Change: I am pleased to report today that we have selected a fixed-dose combination tablet that achieves comparable drug exposure to individually administered Benifazivir and Rizovir.

Speaker Change: This new tablet allows us to decrease the daily pill burden from four tablets to two, which is more convenient, obviously, for the patient.

Irensa: This new tablet will be used in the Phase III program, as well as for subsequent commercialization. And Irensa will review the data in detail for you.

Speaker Change: Lastly, with $502 million of cash, cash equivalent and marketable securities at June 30th.

Speaker Change: We are in a strong financial position to execute our strategy and we anticipate our runway will extend in 2027.

Speaker Change: With that, I will now turn the call over to Irensa for an update on our Global Phase II HCV program.

Aransha Horga: Thank you, Jean-Pierre. Now, we will review our HCV program and some highlights. Turning to slide 5, HCV continues to be a recognized healthcare crisis in the U.S., with between 2 to 4 million people living with HCV, and new challenges continue to hinder progress toward eliminating it globally. With the incidence of new infections annually outpacing the rate of those being treated with direct acting antivirals, it is clear that there are still unmet medical needs.

Irensa: Thank you, Jean-Pierre. Let's now review our HCV program and some highlights.

Irensa: Turning to slide 5, HCV continues to be a recognized healthcare crisis in the U.S. with between 2 to 4 million people living with HCV, and new challenges continue to hinder progress toward eliminating it globally.

John Pierre Somidosi: With the incidence of new infections annually outpacing the rate of those being treated with direct acting antivirals, it is clear that there are still unmet medical needs. Moving to slide 6, the U.S. HCV treatment demand grew roughly 5% in 2023 based on the number of patients treated, while the share of the two key treatment options, EPCLUSA, and Maviret, remained stable.

Irensa: With the incidence of new infections annually outpacing the rate of those being treated with direct-acting antivirals, it is clear that there are still unmet medical needs.

Aransha Horga: Moving to slide six, the U.S. HCV treatment demand grew roughly 5% in 2023 based on the number of patients treated. However, the share of the two key treatment options, EPCLUSA and Maviret, remained stable. Given the current limitations and prescription trends, we believe a best-in-class profile, together with anticipated future government initiatives and improved patient access, will increase the number of patients treated.

Irensa: Moving to slide 6, the U.S. HCV treatment demand grew roughly 5% in 2023 based on the number of patients treated. The share of the two key treatment options, EPCLUSA and MADIRET, remained stable.

John Pierre Somidosi: Given the current limitations and prescription trends, we believe a best-in-class profile, together with anticipated future government initiatives and improved patient access, will increase the number of patients treated. We believe that the profile of Benifazfovir and Ruzivir has the potential to drive the future standard of care. Moving to slide 7, the profile of the patient has changed since the introduction of direct acting antivirals. Today, most U.S. infected patients are younger in age, and infections are highest among the age group between 30 to 39 years old.

Irensa: Given the current limitations and prescription trends, we believe a best-in-class profile together with anticipated future government initiatives and improved patient access will increase the number of patients treated.

Aransha Horga: We believe that the profile of Benifazfovir and Roosveer has the potential to drive the future standard of care. Moving to slide 7, the profile of the patient has changed since the introduction of direct acting antivirals. Today, most U.S. infected patients are younger in age, and infections are highest among the age group between 30 to 39 years old. They are recently infected, and less than 10% are cirrhotic. A high proportion of current patients take multiple concomitant medications, including HIV medications, antipsychotics, statins, and proton pump inhibitors. And in addition, populations at the highest risk for HCV are frequently poorly adherent to their medication due to substance abuse disorders, including opiate use or other drugs and mental health disorders.

Irensa: We believe that the profile of beniphosphobia and russisphere has the potential to drive the future standard of care.

Irensa: Moving to slide 7, the profile of the patient has changed since the introduction of direct acting antivirals.

Speaker Change: today most u s infected patients are younger in age and infections are highest among the age group between thirty to thirty nine years old

Speaker Change: They are recently infected and less than 10% are cirrhotic.

Irensa: A high proportion

Speaker Change: of the current patients, take multiple concomitant medications, including HIV medications, antipsychotics,

Irensa: statins, proton pump inhibitors, and in addition, populations at the highest risk for HCV are frequently poorly adherent to their medication due to substance abuse disorders, including opiate use or other drugs, and mental health disorders.

Aransha Horga: For this patient profile, a direct acting antiviral with a low risk of drug-drug interactions combined with a short treatment duration and no food effect would address these unmet needs and treat more patients successfully. Slide eight reviews our potential best-in-class regimen, which combines the most compelling attributes of current HCV drug treatments. It is protease inhibitor-free and has a short eight-week treatment duration. Our combination also has a low risk of drug-drug interactions, and there is no food effect.

John Pierre Somidosi: They are recently infected, and less than 10% are cirrhotic. For this patient profile, a direct acting antiviral with a low risk of drug-drug interactions, combined with a short treatment duration and no food effect would address these unmet needs and treat more patients successfully. As a reminder, the leading cohort of 60 patients was comprised of non-cirrhotic patients only. However, 10 patients had an advanced stage of fibrosis, F3, which is borderline with cirrhosis.

Speaker Change: For this patient profile, a direct-acting antiviral with low risk of drug-drug interactions combined with short treatment duration and no food effect would address these unmet needs and treat more patients successfully.

Speaker Change: Slide eight.

Speaker Change: Reviews Our Potent.

Speaker Change: potential best in class regimen which combines the most compelling attributes of current HCV drug treatments. It is protease inhibitor free with a short eight-week treatment duration.

Speaker Change: Our combination also has a low risk of drug-drug interactions and there is no food effect.

Aransha Horga: Slide nine reviews the data for the selected fixed-dose combination tablet of benifosfobir and brucesvir that we will be using in our phase three program and for subsequent commercialization. This new tablet allows us to decrease the daily pill count from four to two, which is more convenient for the patient. As you can see from the two graphs, the PIXOS combination drug exposure is comparable to individually administered Benifoz, Fovir, and Ruzesbin. In addition, there is no food effect.

Speaker Change: Slide 9 reviews the data for the selected fixed-dose combination tablet of benifosfovir and ruzesvir that we will be using in our Phase III program and for subsequent commercialization.

Speaker Change: This new tablet allows us to decrease the daily pill count from four tablets to two, which is more convenient for the patient.

Speaker Change: As you can see from the two graphs, the fixed-dose combination drug exposure is comparable to individually administered Benifoz, Fovir, and Rusesbin. In addition, there is no food effect.

Aransha Horga: In slide 10, we outline our phase two single-arm open-label study of 550 milligrams of beniphosphobir in combination with 180 milligrams of rusesvir once daily for eight weeks. I will discuss the results shortly. In this Phase II trial, which is currently ongoing, we enrolled 275 treatment-based patients, including the leading cohort of 60 patients. The primary endpoint of the study is SVR at week 12, post-treatment, and safety. Moving to slide 11.

Speaker Change: In slide 10, we outline our Phase II single-arm open-label study of 550 mg of benifosforbir in combination with 180 mg of rusesvir once daily for 8 weeks.

Speaker Change: I will discuss the results shortly. In this Phase II trial, which is currently ongoing, we enrolled 275 treatment-nased patients, including the leading cohort of 60 patients.

Speaker Change: The primary endpoint of the study is SDR at week 12 for treatment and safety.

Aransha Horga: As a reminder, the leading cohort of 60 patients was comprised of non-cirrhotic patients only. However, 10 patients had an advanced stage of fibrosis, F3, which is borderline with cirrhosis. This slide shows the untreated viral kinetics of individual patient data from the leading cohort. As you can see, there was a rapid reduction of viral load in all patients within the first week, regardless of baseline viremia and genotype. By week four on treatment, all 60 patients in the leading cohort had a viral load near or below the lower limit of quantification, and the virus was undetectable. Therefore, these very rapid kinetics across all genotypes support an eight-week regimen and compare favorably to Maviret, which is the only approved eight-week treatment for HCV.

Speaker Change: Moving to slide 11.

Speaker Change: As a reminder, the leading cohort of 60 patients were comprised of non-cirrhotic patients only. However, 10 patients had an advanced stage of fibrosis, F3, which is borderline with cirrhosis.

John Pierre Somidosi: This slide shows the on-treatment viral kinetics of individual patient data from the leading cohort. As you can see, there was a rapid reduction of viral load in all patients within the first week, regardless of baseline viremia and genotype. Results from the leading cohort also show an SVR12 rate of 100% in all 13 patients infected with genotype 3, a historically difficult-to-treat genotype of HCV. Data also showed a 98% SVR12 rate in 43 out of 44 patients with genotype 1. Turning to slide 14.

Speaker Change: This slide shows the on-treatment viral kinetics of individual patient data from the leading cohort. As you can see, there was a rapid reduction of viral load in all patients within the first week regardless of baseline viremia and genotype.

Speaker Change: By week four on treatment, all 60 patients in the leading cohort had a viral load near or below the lower limit of quantification, and the virus was undetectable. Therefore, this very rapid kinetics across all genotypes

Speaker Change: Support an 8-week regimen and compare favorably to Maviret, which is the only approved 8-week treatment for HCV.

Aransha Horga: Turning to slide 12, in June, we presented data at ESOL from the leading cohort of 60 patients. We are pleased with the results, which showed a high SBR-12 rate of 97% with a short eight-week duration treatment. Importantly, the only two patients with post-treatment relapse or failure demonstrate the challenge of drug adherence in this patient population, which I'm going to review in further detail. On slide 13.

Speaker Change: Turning to slide 12.

Speaker Change: In June , we presented data at ESOL.

Speaker Change: from the leading cohort of 60 patients.

Speaker Change: We are pleased with the results.

Speaker Change: which showed a high SBR-12 rate of 97% with a short eight-week duration treatment.

Speaker Change: Importantly, the only two patients with post-treatment relapse or failure demonstrate the challenge of drug adherence in this patient population, which I'm going to review in further detail.

Aransha Horga: Results from the leading cohort also show a SVR-12 rate of 100% in all 13 patients infected with genotype 3, a historically difficult-to-treat genotype of HCV. Data also showed a 98% SVR-12 rate in 43 out of 44 patients with genotype 1. Turning to slide 14.

Pam: On slide 13,

Pam: Results from the leading cohort also show a SVR12 rate of 100% in all 13 patients infected with genotype 3, a historically difficult-to-treat genotype of HCV.

Speaker Change: Data also showed a 98% SBR-12 rate in 43 out of 44 patients with Genotype 1.

Aransha Horga: As mentioned earlier, two subjects that were genotype 1b and genotype 2b experienced post-treatment relapse in the leading cohort. This slide shows the vial kinetics, plasma drug levels, and resistance sequencing data of the genotype 1b patient. The viral relapse or failure was due to treatment non-adherence and not due to viral resistance as indicated by the lack of new mutations. This was demonstrated by low plasma and inadequate drug levels at week 6 and week 8 and similar viral mutations at baseline and 12 weeks post-treatment. And on slide 15.

John Pierre Somidosi: As mentioned earlier, two subjects that were Genotype 1b and Genotype 2b experienced post-treatment relapse in the leading cohort. This slide shows the viral kinetics, plasma drug levels, and resistance sequencing data of the Genotype 1b patient. The viral relapse or failure was due to treatment non-adherence and not due to viral resistance, as indicated by the lack of new mutations. This was demonstrated by low plasma and inadequate drug levels at week 6 and week 8 and similar viral mutations at baseline and 12 weeks post-treatment, and on slide 15, combined with similar viral mutations at baseline and 12 weeks post-treatment.

Speaker Change: Turning to slide 14.

Speaker Change: As mentioned earlier, two subjects that were Genotype 1b and Genotype 2b experienced post-treatment relapse in the leading cohort.

Speaker Change: This slide shows the vial kinetics, plasma drug levels, and resistance sequencing data of the Genotype 1B patient.

Speaker Change: The viral relapse or failure was due to treatment non-adherence and not due to viral resistance as indicated by the lack of new mutations.

Speaker Change: This was demonstrated by low plasma and inadequate drug levels at week 6 and week 8, and similar viral mutations at baseline and 12 weeks post-treatment.

Speaker Change: and on slide 15,

Aransha Horga: We see the viral kinetics, plasma drug levels, and resistance sequencing data of the genotype 2B patient. Once again, low plasma and inadequate drug levels at week six and week eight. Combined with similar viral mutations at baseline and 12 weeks post-treatment, the lack of new mutations indicates that the observed relapse or failure was due to treatment non-adherence rather than viral failure due to resistance. These data further outline the challenge of drug adherence in the current patient population and reinforce the need for short treatment duration and convenient therapy.

Speaker Change: We see the viral kinetics, plasma drug levels, and resistance sequencing data of the genotype 2b patient.

Speaker Change: Once again, low plasma and inadequate drug levels at week six and week eight, combined with similar viral mutations at baseline and 12 weeks post-treatment.

Speaker Change: The lack of new mutations indicate that the observed relapse or failure was due to treatment non-adherence rather than viral failure due to resistance.

John Pierre Somidosi: These data further outline the challenge of drug adherence in the current patient population and reinforce the need for short treatment duration and convenient therapy. The combination of benifosforvir and ruzivir was generally safe and well-tolerated in the leading cohort. There were no drug-related serious adverse events, no discontinuations, and adverse events were mostly mild.

Speaker Change: These data further outline the challenge of drug adherence in the current patient population and reinforce the need for short treatment duration and convenient therapy.

Aransha Horga: On slide 16, we see yet another example showing that poor drug adherence in this population remains a challenge. However, in these two patients that were poorly adherent, the high potency of our combination still led to a positive outcome of achieving SBR-12 or cure. On the next slide, slide 17.

Speaker Change: On slide 16.

Speaker Change: We see yet another example showing that poor drug adherence in this population remains a challenge. However, in these two patients that were poorly adherent, the high potency of our combination still led to a positive outcome of achieving SDR-12 or cure.

Aransha Horga: The combination of Benifozfavir and Ruzavir was generally safe and well-tolerated in the leading cohort. There were no drug-related serious adverse events, no discontinuations, and adverse events were mostly mild. Turning to slide 18 to summarize our HCV efforts, in June, we completed enrollment of 275 patients. The study is ongoing, and we expect to report complete SVR-12 results in the fourth quarter of this year. We have selected the fixed-dose combination tablet, which will be used in the Phase 3 program and for subsequent commercialization.

Speaker Change: On the next slide, slide 17.

Speaker Change: The combination of benifosforvir and ruzivir were generally safe and well-tolerated in the leading cohort. There were no drug-related serious adverse events, no discontinuations, and adverse events were mostly mild.

John Pierre Somidosi: Turning to slide 18 to summarize our HCV efforts, in June, we completed enrollment of 275 patients. We have selected the fixed-dose combination tablet, which will be used in the Phase 3 program and for subsequent commercialization. We are on track with activities to initiate the Phase 3 program around the end of this year. And, pending discussions with regulatory agencies, we expect to conduct two studies with at least one having an active comparison.

Speaker Change: Turning to slide 18 to summarize our HCV efforts, in June we completed enrollment of 275 patients. The study is ongoing and we expect to report complete SVR-12 results in the fourth quarter of this year.

Aransha Horga: We are on track with activities to initiate the Phase 3 program around the end of this year, and pending discussions with regulatory agencies, we expect to conduct two studies with at least one having an active comparison. We are excited about the significant progress and the positive results we have achieved for the HCV program and look forward to providing more updates throughout the rest of this year. And with that, I will now turn the call over to Janet to discuss our COVID-19 and the global phase 3 sanitization plan.

Speaker Change: We have selected the fixed-dose combination tablet, which will be used in the Phase III program and for subsequent commercialization. We are on track with activities to initiate the Phase III program around the end of this year.

Speaker Change: And pending discussions with regulatory agencies, we expect to conduct two studies with at least one having an active comparator.

John Pierre Somidosi: We are excited about the significant progress and the positive results we have achieved for the HCV program and look forward to providing more updates throughout the rest of this year. And with that, I will now turn the call over to Janet to discuss our COVID-19 and the global phase 3 study.

Speaker Change: We are excited about the significant progress and the positive results we have achieved for the HCV program and look forward to providing more updates throughout the rest of this year. And with that, I will now turn the call over to Janet to discuss our COVID-19 and the global Phase 3, Sunrise 3 trial.

Janet Hammond: Thanks, Arantxa. Good afternoon, everyone.

Janet: Thanks, Arantxa. Good afternoon, everyone. Turning to slide 20.

Janet Hammond: Turning to slide 20. COVID-19 continues to evolve, and as Jean-Pierre mentioned earlier, we're now experiencing a summer wave across the U.S., Europe, and other global locations, which is largely being driven by the new K-P and LB1 variants. Viral waste water modeling suggests the current US COVID wave is currently around 900,000 new cases daily in. High-risk populations, such as the elderly, those who are immunocompromised, and those with underlying risk factors, are more likely to become severely ill with COVID-19. There's a continuing unmet medical need, and our goal for COVID-19 is to deliver a safe and effective treatment that addresses the key limitations of current Slide 21.

Janet: COVID-19 continues to evolve and as Jean-Pierre mentioned earlier, we're now experiencing a summer wave across the US, Europe , and other global locations which is largely being driven by the new Kp and Lb1 variants.

Speaker Change: Viral wastewater modeling suggests the current U.S. COVID wave currently is around 900,000 new daily infections.

Janet Hammond: High-risk populations, such as the elderly, those who are immunocompromised, and those with underlying risk factors, are more likely to become severely ill with COVID-19. Benifostavir has a robust target profile with a low risk for drug-drug interaction, favorable safety and tolerability, and a distinct mechanism of action with a high barrier to treatment. We've completed several studies evaluating benifocibia for COVID-19. The risk of hospitalization was 71% lower for beniphosphazir versus placebo and 82% in patients over the age of 40.

Janet: High-risk populations, such as the elderly, those who are immunocompromised and those with underlying risk factors, are more likely to become severely ill with COVID-19.

Speaker Change: There is a continuing unmet medical need, and our goal for COVID-19 is to deliver a safe and effective treatment that addresses the key limitations of current available therapies.

Janet Hammond: Benny Foster there has a robust target profile with a low risk for drug-drug interaction, favorable safety and tolerability, and a distinct mechanism of action with a high barrier to treatment. We've completed several studies evaluating benifocibia for COVID-19 in the Morning Sky Trial in Alpesh. The risk of hospitalization was 71% lower for beniphosphazia versus placebo and 82% in patients over the age of 40. In addition, in a Phase II study in hospitalized patients, there were no deaths in patients administered beniphosphavir in comparison with three deaths in the placebo group. Moving to slide 22.

Janet: Site 21

Janet: Benny Foster there has a robust target profile with a low risk for drug-drug interaction, favorable safety and tolerability, and a distinct mechanism of action with a high barrier to treatment resistance.

Janet: We've completed several studies evaluating Benifazpivir for COVID-19.

Janet: in the MorningSky trial in outpatients.

Speaker Change: The risk of hospitalization was 71% lower for beniphosphazia versus placebo, and 82% in patients over the age of 40 years.

Janet Hammond: In addition, in a Phase II study in hospitalized patients, there were no deaths in patients administered beniphosphavir in comparison with three deaths in the placebo group. Moving to slide 22. This Phase 3 study was randomized, double-blind, and procedure controlled. The study drug, either Benifostavir 550 mg twice a day or placebo, was administered concurrently with the locally available standard of care.

Speaker Change: In addition, in a Phase II study in hospitalized patients, there were no deaths in patients administered beniphosphavir in comparison with three deaths in the placebo group.

Janet Hammond: The Global Phase 3 Sunrise 3 trial enrolled only high-risk outpatients with mild or moderate COVID-19, regardless of their vaccination state, if symptom onset was five or less days before randomization. This Phase 3 study was randomized, double-blind, and procedure controlled. The study drug, either benifostavir 550 mg twice a day or placebo, was administered concurrently with the locally available standard of care, including other compatible COVID-19 antiviral drugs at the discretion of the investigator. The primary endpoint of the study is all-cause hospitalization or death through day 29 in the supportive care monotherapy population. Turning to slide 23.

Janet: Moving to slide 22.

Speaker Change: The Global Phase 3 Sunrise 3 trial enrolled only high-risk outpatients with mild or moderate COVID-19, regardless of their vaccination status.

Janet: Symptom onset was five or less days before randomization.

Janet: This Phase III study was randomized, double-blind, and procedure-controlled.

Speaker Change: The study drug, either Benifostavir 550 mg twice a day or placebo, was administered concurrently with the locally available standard of care.

Speaker Change: including other compatible COVID-19 antiviral drugs at the discretion of the investigator.

Speaker Change: The primary endpoint for the study is all cause hospitalization or death through day 29 in the supportive care monotherapy population.

Janet Hammond: In summary, we enrolled 2,221 patients in the Monotherapy Co, and only 74 patients in the combination. The high rate of enrollment in the monetary cohort shows a clear preference by investigators for a new therapy and highlights the major unmet medical need for new oral COVID-19 treatment options for these high-risk patients. We look forward to providing the results from our phase 3 trial during the second half of 2024. I'll now turn the call over to John to discuss the COVID-19 market opportunity.

Speaker Change: Turning to slide 23, in summary, we enrolled 2,221 patients in the monotherapy cohort.

Janet: and only 74 patients in the combination cohort.

Speaker Change: The high rate of enrollment in the monotherapy cohort shows a clear preference by investigators for a new therapy and highlights the major unmet medical need for new oral COVID-19 treatment options for these high-risk patients.

Janet: We look forward to providing the results from our pastry trail during the second half of 2024.

Janet: I'll now turn the call over to John to discuss the COVID-19 market opportunity.

John Vavricka: Thanks, Janet. Moving to slide 24, the U.S. prescription demand for oral antivirals to treat COVID-19 highly correlates with the infection. Of note, there was an increase of 32% in COVID-19 oral antiviral prescriptions for June 2024 versus June 2023, correlating with the early summer wave related to the KP and LV1 variant. We are confident that the market opportunity for oral antiviral therapeutics for COVID-19 will continue to remain a multi-billion dollar opportunity for the long run.

John: Thanks, Janet. Moving to slide 24, the U.S. prescription demand for oral antivirals to treat COVID-19 highly correlates with the infection rates.

John Pierre Somidosi: Of note, there was an increase of 32% in COVID-19 oral antiviral prescriptions for June 2024 versus June 2023, correlating with the early summer wave related to the K-P and LV1 variant. We are confident that the market opportunity for oral antiviral therapeutics for COVID-19 will continue to remain a multi-billion dollar opportunity for the long run. This is supported by Acuvia's retail prescription data indicating between four and five billion dollars of annual revenues between the two currently available oral antiviral products. I'll now turn the call over to Andrea to discuss Atea's funding.

John: Of note, there was an increase of 32% in COVID-19 oral antiviral prescriptions for June 2024 versus June 2023, correlating with the early summer wave related to the KP and LV1 variants.

Speaker Change: We are confident the market opportunity for oral antiviral therapeutics for COVID-19 will continue to remain a multi-billion dollar opportunity for the long run.

John Vavricka: This is supported by Acuvia's retail prescription data indicating between $4 and $5 billion of annual revenues between the two currently available oral antiviral products. Between feedback from patients and physicians and the available data, it's clear there is a significant unmet need for an antiviral treatment option that addresses the limitations related to drug-drug interactions and tolerability with PAX Lovid and safety concerns with Legabria. We believe in Benifocivir and its potential to meaningfully improve the COVID-19 treatment paradigm and bring tremendous value to patients. I'll now turn the call over to Andrea to discuss Atea's funding.

Speaker Change: This is supported by IQVIA's retail prescription data, indicating between four and five billion dollars of annual revenues between the two currently available oral antiviral products.

Speaker Change: Between feedback from patients and physicians and the available data, it's clear there is a significant unmet need for an antiviral treatment option that addresses the limitations related to drug-drug interactions and tolerability with PAX-Logid and safety concerns with Legabrio.

Speaker Change: We believe in Benifocivir and its potential to meaningfully improve the COVID-19 treatment paradigm and bring tremendous value to patients and physicians.

Andrea Corcoran: Thank you, John. As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the second quarter of 2024. Statement of Operations and Balance Sheet can be found on slides 26 and 27. As you'll note, in the second quarter of 2024, there was a marked increase in research and development expenses compared to the prior year period. This increase was related to the advancement and subsequent completion of patient enrollment for both our Phase 3 Sunrise 3 COVID-19 clinical trial and our Phase 2 HCV trial.

Speaker Change: I'll now turn the call over to Andrea to discuss Atea's financials.

Andrea: Thank you, John . As Jonae mentioned in her introductory remarks, earlier today we issued a press release containing our financial results for the second quarter of 2024. The statement of operations and balance sheet can be found on slides 26 and 27.

Andrea Corcoran: Statement of Operations and Balance Sheet can be found on slides 26 and 27. As you'll note, in the second quarter of 2024, there was a marked increase in research and development expenses compared to the prior year period. This increase was related to the advancement and subsequent completion of patient involvement for both our Phase 3 Sunrise 3 COVID-19 clinical trial and our Phase 2 HCV trial. However, interest income in the second quarter of 2024 decreased compared to the second quarter of 2023 due to a lower investment balance.

Speaker Change: As you'll note, in the second quarter of 2024, there was a marked increase in research and development expenses compared to the prior year period.

Speaker Change: This increase was related to the advancement and subsequent completion of patient enrollment for both our Phase 3 Sunrise 3 COVID-19 clinical trial and our Phase 2 HCV trial.

Andrea Corcoran: For general and administrative expenses, there was a decrease in the quarter compared to the corresponding period in 2023. This decrease was attributable to incurring lower professional fees in the second quarter of 2024. Interest income in the second quarter of 2024 decreased compared to the second quarter of 2023 due to a lower investment balance.

Speaker Change: For general and administrative expenses, there was a decrease in the quarter compared to the corresponding period in 2023. This decrease was attributable to incurring lower professional fees in the second quarter of 2024.

Speaker Change: Interest income in the second quarter of 2024 decreased compared to the second quarter of 2023 due to lower investment balances.

Andrea Corcoran: During the remainder of 2024, we expect our R&D spend to vary as our Sunrise III and our HCV studies complete, and we further activities to initiate the HCV program in the fourth quarter of the year. As Jean-Pierre mentioned, at the end of the second quarter of 2024, our cash, cash equivalents, and marketable securities balance was $502.2 million. Maintaining our strong financial discipline and strategically focused investment, we project our cash guidance runway into 2027. I'll now hand the call back to Jean-Pierre for closing remarks.

Speaker Change: During the remainder of 2024, we expect our R&D spend to vary as our Sunrise III and our HCV studies complete, and we further activities to initiate the HCV program in the fourth quarter of the year.

jump peer: As Jean-Pierre mentioned, at the end of the second quarter of 2024, our cash, cash equivalent and marketable securities balance was $502.2 million.

Speaker Change: Maintaining our strong financial discipline, strategically focused investment, we project our cash guidance runway into 2027.

Speaker Change: I'll now hand the call back to Jean-Pierre for closing remarks.

Andrea Corcoran: In closing, on slide 29. I'm very pleased with the significant clinical progress we have made this year. The multiple key milestones for both programs expected throughout the remainder of 2024 have the potential to drive significant shareholder value and positions out there for an exciting rest of the year. We continue to make progress with our Early Stage Discovery Program, as a relatively small organization. I'd like to remind you, with fewer than 80 employees, I'm extremely pleased with the effort and the achievement of the team, with successful execution of two global studies on multi-million dollar market opportunities and still being very financially responsible.

John Pierre Somodosy: In closing slide 29, I'm very pleased with the significant clinical progress we have made this year across the BOSS Program.

Jean-Pierre: So, in closing on slide 29, I'm very pleased with the significant clinical progress we have made this year across

John Pierre Somodosy: The multiple key milestones for both programs expected throughout the remainder of 2024 have the potential to drive significant shareholder value and positions out there for an exciting rest of the year for our COVID-19 program. We expect to report top-line results from Sunrise 3 in the second half of 2024, and we are targeting the NDA submission around the year end. Additionally

Speaker Change: Both programs.

Speaker Change: The multiple key milestones for both programs expected throughout the remainder of 2024 have the potential to drive significant shareholder value and positions up there for an exciting rest of the year.

Speaker Change: for our COVID-19 program.

Speaker Change: We expect to report top-line results.

Speaker Change: from Sunrise 3 in the second half of 2024, and we are targeting the NDA submission around the year-end. Additionally...

John Pierre Somodosy: We continue to also make progress with our Early Stage Discovery Program, focused on highly differentiated second generation protease inhibitors, and we will provide an update later this year. For HCV, the data presented at ESOL demonstrate a potential best-in-class profile that combine, as our answer mentioned, the most compelling attributes of current HCV drug treatment through the innovative combination of benifocib and mucosal via. And we look forward to reporting the full results of 275 patients for our Phase II study during the fourth quarter of this year. As a relatively small organization,

Speaker Change: We continue to also make progress with our early stage discovery program, focused on the highly differentiated second generation protease inhibitors, and we will provide an update later this year.

Speaker Change: For HCV, the data presented are easel.

Speaker Change: Demonstrate.

Erenza: A potential best-in-class profile that combines, as Lorenzo mentioned, the most compelling attributes.

Erenza: of Current HCV Drug Treatment through the innovative

Speaker Change: combination of Benifazio and Misesvia. And we look forward to reporting the full results in 275 patients for our Phase 2 study during the fourth quarter of this year.

John Pierre Somodosy: I'd like to remind you that, with fewer than 80 employees, I'm extremely pleased with the effort and the achievement of the team, with successful execution of two global studies in multi-million dollar market opportunities and still being very financially responsible. We believe that our product candidates are highly differentiated and have the opportunity, if approved, to address significant unmet medical needs in the current treatment landscape, and both have strong blockbuster potential. With that, I will now turn the call back over to the operator. Thank you.

Speaker Change: as a relatively small organization.

Speaker Change: I'd like to remind, with fewer than 80 employees, I'm extremely pleased with the effort and the achievement of the team.

Speaker Change: with successful execution on two global studies in multi-million dollar market opportunities and still being very financially responsible.

Andrea Corcoran: We believe that our product candidates are highly differentiated and have the opportunity, if approved, to address significant unmet medical needs in the current treatment landscape, and both have strong blockbuster potential. With that, I will now turn the call back over to the operator. Thank you.

Speaker Change: We believe that our product candidates are highly differentiated and have the opportunity, if approved, to address significant unmet medical needs in the current treatment landscape and boast a strong blockbuster potential.

Operator: Thank you. And as a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A list. And our first question comes from the line of Maxwell Skor with Morgan Stanley. Your line is open.

Speaker Change: With that, I will now turn the call back over to the operators.

Speaker Change: Thank you. And as a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.

Operator: And our first question comes from the line of Maxwell Skor with Morgan Stanley. Your line is open.

Speaker Change: And our first question comes from the line of Maxwell Skor with Morgan Stanley . Your line is open.

Maxwell Score: Great, thank you for taking my questions. Can you just walk me through the payer dynamic for hep C? What percent of chronic hep C patients are on Medicaid? And are these patients prescribed generic EPCLUSA in general? Thank you.

Maxwell Skor: John, do you want to address the question?

John Vavricka: Sure. So, for Hep C, you know, the government-supported programs, both Medicaid and Medicare, as you would expect, comprise the larger majority from the payer perspective, followed up by commercial lives. Your question as regards, from an inclusive point of view, whether it's the brand or an authorized copy. Both of those, both the authorized copy and the brand, are still selling products and are pretty much dictated by the dynamics of the various payers. Some have their financial incentives driven off of the wholesale acquisition cost, while others look at just direct net discounts. But both of them do exist, depending on the models that the individual payers have.

Speaker Change: John , you want to address the question?

John: Sure. So for hep C, you know, the government supported programs with Medicaid and Medicare, as you would expect, comprise the larger majority from the payer perspective.

Speaker Change: and then followed up by Commercial Lives.

Speaker Change: Your question as regards to from inclusive, whether it's the brand or authorized copy.

John Vavricka: Both of those, both the authorized copy and the brand, are still selling products, and they are pretty much dictated by the dynamics of the various payers. Some have their financial incentives driven off of the wholesale acquisition cost. Others look at just direct net discounts. But both of them do exist, depending on the models that the individual payers have.

Speaker Change: those

Speaker Change: of those, both the author of the copy and the brand, are still selling products and pretty much are dictated.

Speaker Change: by the dynamics of the various payers. Some have their financial incentives driven off of the wholesale acquisition cost. Others look at just direct net discounts. But both of them do exist depending on the models that the individual payers have.

Unknown Speaker: Unknown Speaker Just Unknown Speaker

Unknown Speaker: Unknown Speaker

Unknown Speaker: Just to add, Max, to John, we are talking about authorized copies, not generics. Actually, we all know, or maybe I can share, that the IP so far that we are, that is public, both for Marivet and Exclusiva, will go at least until 2026. So we don't anticipate the entry of so-called generics before 2036 for both approved drugs.

Unknown Speaker: Just to add, Max, to John, we are talking about authorized copies, not generics. Actually, we all know, or maybe I can share, that the IP so far that we are, that is public, both for Marivet and Epsilusta, will go at least until 2026. So we don't anticipate the entry of so-called generics before 2036 for both approved drugs.

Speaker Change: Just to add, Matt,

Speaker Change: To John , we are talking about authorized copy, not generics.

Speaker Change: Actually we all know, or maybe I can share, that the IP so far that we are, that is public, both for Maribet and Epsos, will go at least until 2026.

Speaker Change: So we don't anticipate the entry of so-called generics before 2036 for both approved drugs.

John Miller: Thank you. And our next question comes from the line of John Miller with Evercore. Your line is open.

Speaker Change: Okay, thank you.

Speaker Change: Thank you. And our next question comes from the line of John Miller with Evercore. Your line is open.

Unknown Speaker: Hi guys, thanks for taking the question. I recently noticed that Pfizer has a next-gen Paxilvid in development with no metallic taste, no ritonavir, higher potency at target, so a lot of the same things that we've been talking about with preventive osteovir in the COVID space. So do you, I assume you've seen their paper, do you still expect to have a competitive edge versus that sort of a program? And what are your plans to commercialize in the space next to, say, a major player like Pfizer?

John Miller: Hi guys, thanks for taking the question. I recently noticed that Pfizer has a next-gen Paxilid in development with no metallic taste, no ritonavir, higher potency at target, so a lot of the same things that we've been talking about preventing fosfavir in the COVID space.

Speaker Change: So, do you, I assume you've seen their paper, do you still expect to have a competitive edge versus that sort of a program and what are your plans to commercialize in the space next to, like versus a major player like Pfizer?

Unknown Speaker: Okay, so thank you, John. Great question.

Speaker Change: Okay, so thank you, John . Great question. Janet, do you want to address the first part and then John will do the commercial?

Unknown Speaker: So I'm looking forward to it.

Unknown Speaker: Janet, do you want to address the first part and then John will do the commercial? Unknown Speaker. Thank you.

Janet Hammond: Certainly, so thank you very much for the question. It is an interesting one. Obviously, they've got a long way to go. And, you know, we look forward to seeing how the program progresses.

Unknown Speaker: Certainly, so thank you very much for the question. It is an interesting one.

Janet: Thank you. Thank you.

Unknown Speaker: Obviously, they've got a long way to go, and, you know, we look forward to seeing how the program progresses. Certainly, we believe that having more than one mechanism of action available for patients is going to be important. I think, particularly with the substantial uptake that there is already with Pax Lovis, but I know that it could be a lot higher when you look at the number of cases. But, as John mentioned, with the commercial uptake that we see, there is significant use of Pax Lovis.

Janet: certainly so i thank you very much the question it is an interesting one obviously they've got a long way to go and know we look forward to seeing how the program progresses

Janet Hammond: Certainly, we believe that having more than one mechanism of action available for patients is going to be important, particularly with the substantial uptake that there is already with Pax Lovis. I mean, I know that it could be a lot higher when you look at the number of cases. But as John mentioned, with the commercial uptake that we see, there is significant use of Pax Lovis, and Unknown Speaker, Transcription Overview, Professor Jane Horton, Ph.

John: Certainly, we believe that having more than one mechanism of action available for patients is going to be important. I think particularly...

John: with the substantial uptake that there already is with Pax Lovis. I mean, I knew that it could be a lot higher when you look at the number of cases, but as John mentioned with the commercial uptake that we see, there is significant use of Pax Lovis.

Janet Hammond: D. We all know that with the use of protein inhibitors, there's a potential for the generation of resistance, and this is much less likely with a nucleoside analog. So we believe that there's certainly scope for both in the market, and I think were there to be more agents, it would be of benefit to everybody. But you know, we're confident of the profile as we've seen with our drug, and we look forward to seeing more.

John: All with use of protein inhibitors, there's a potential for the generation of resistance.

John: This is much less likely with a nucleoside analog, so we believe that there's certainly scope for both in the marketplace, and I think were there to be more agents, it would be of benefit to everybody.

John: But, you know, we're confident of the profile that we've seen with our drug and we look forward to seeing more about that.

John Vavricka: John, from a commercial perspective, although we don't comment on partnering discussions that, you know, for the U.S., for our COVID-19 programs, we plan to co-promote with a pharmaceutical company, and the criteria for them would have primary care and managed care capabilities and, of course, a commercial infrastructure. So from a competitive standpoint, we would feel very confident from a future partner standpoint.

Janet: John and the rest of the group...

Speaker Change: Sure, from a commercial perspective, although we don't comment on partnering discussions that, you know, for the U.S., you know, for our COVID-19 programs, we plan to co-promote with a pharmaceutical company, and the criteria for them would have

Janet: Primary Care and Managed Care Capabilities, and of course a commercial infrastructure. So, from a competitive standpoint, we would feel very confident from a future partner standpoint.

Operator: And I'm showing no further questions at this time. I would now like to turn the call back to Jean-Pierre for closing remarks.

Speaker Change: Make sense. Thanks, guys.

Speaker Change: And I'm showing no further questions at this time. I would now like to turn the call back to Jean-Pierre for closing remarks.

John Pierre Somodosy: So, thank you all for joining our second quarter 2024 conference call. And thank you as well for your continued support.

Jean-Pierre: So thank you all for joining our second quarter of the 2024 Earnings Conference call, and thank you as well for your continued support.

Operator: This concludes today's conference call. Thank you all for participating. You may now disconnect.

Speaker Change: This concludes today's conference call. Thank you all for participating. You may now disconnect.

Q2 2024 Atea Pharmaceuticals Inc Earnings Call

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