Atea Pharmaceuticals Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 8, 2023

There are 11 speakers on the call.

Operator

Afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals Second Quarter 2023 Financial Results and Business Update Conference Call. At this time, all participants are in a listen only mode. Following the formal remarks, we will open the call up for your questions. I would now like to turn the call over to Janae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals.

Operator

Ms. Barnes, please proceed.

Speaker 1

Thank you, operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' 2nd quarter 2023 Financial Results and Business Update Conference Call. Earlier today, we issued a press release, which outlines the topics we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by going to the Investors section of our website at ir. Atayapharma.com.

Speaker 1

With me from ATAYA are our Chief Executive Officer and Founder, Doctor. Jean Pierre Somadose Chief Development Officer, Doctor. Janet Hammond Doctor. Rancho Harga, Chief Medical Officer Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran and our Chief Commercial Officer, John Bavrica. They will all be available for the Q and A portion of today's call.

Speaker 1

Before we begin the call, as outlined on Slide 2, I would like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call. With that, I'll now turn the call over to Jean Pierre.

Speaker 2

Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on Slide 3. During the first half of the year, we have made considerable progress across our COVID-nineteen and HCV program. For COVID-nineteen program, Fast Track designation for the development of Benifosbuvir was granted by the FDA in the 2nd quarter And reflect the continuing unmet medical need that remains for COVID-nineteen patients.

Speaker 2

Data to date, Including multiple data presentation during the first half of the year, support the favorable efficacy, safety And lack of drug interaction profile of Benifazivir. We believe that Benifazivir has the potential to address the key limitations of current COVID-nineteen therapies. With the protocol amendment modification that Janet will review today For our Phase 3 Sunrise 3 trial, we have adapted our protocol to reflect the current status of the pandemic, While still remaining on track with our upcoming near term milestones, which include a near term analysis around the end of the year And top line results from the study anticipated mid-twenty 24. We continue to target an NDA submission by year end 2024. As part of a multi pronged approach against COVID-nineteen, We are advancing a discovery program focused on the 2nd generation protease inhibitor That is highly differentiated and has a clinical profile quite unique and well suited for combination with Benifrostriville.

Speaker 2

We are continuing to make progress with this program and we expect to provide an update around the end of the year. For our HCV program, I'm pleased to report that in June, we began dosing patients in our Phase 2 study Evaluating the combination of venifosbuvir and rosasvir. This was a significant milestone for Atera and we continue to expect Initial results from the leading cohort of approximately 60 patients around the end of the year. Data presented earlier this year At the International Conference on Antiviral Research, support the profile of our HCV combination with in vitro data consistent with a highly competitive profile compared to the current standard of care. Importantly, we are well capitalized And in the strong position to execute on our mission with more than $600,000,000 of cash and cash equivalents and Andrea will go over the details with you.

Speaker 2

I will now turn the call over to Janet for an update on our COVID-nineteen program.

Speaker 3

Good afternoon, everyone. The World Health Organization's current The indication of COVID-nineteen is that it is an established pathogen of concern, and we believe that COVID-nineteen will remain an ongoing immunity from prior infections. This also causes concerns about the boost of keeping pace with the mutating virus. Today, a recently identified COVID-nineteen variant, ARRIS or EG5.1 was reported to be the dominant circulating strain in the U. S.

Speaker 3

Interestingly, it has key mutations that have been linked to the use of monoclonal antibody, further highlighting how prone the virus is to continued mutation with the ability to evade even newly generated monoclonal antibodies. This underscores the important role for direct acting oral antivirals in the treatment of COVID-nineteen. Importantly to note, emnifosbuvir has a high barrier to resistance due to its unique mechanism of action with the same potency against all variants tested, and we're confident that this will be consistently maintained as new variants continue to emerge. COVID-nineteen rates continue to fluctuate globally. Japan has been experiencing its 9th wave.

Speaker 3

And in the last couple of weeks, both the U. S. And Europe are seeing an uptick in infections driven by the heat waves, which is sending people indoors to air conditioned spaces where COVID-nineteen transmits more easily. Turning to Slide 5. Heading into the 4th, we are facing a situation of waning immunity to both natural infection and the current vaccines, which is further exacerbated by a low booster uptake and the potential for mismatch between circulating strains and available boosters.

Speaker 3

Furthermore, in some immunocompromised patients, there is a failure to mount any immune response to the vaccines. The availability and use of oral antivirals is therefore going to be essential, particularly for the elderly, Immunocompromised and those with underlying risk factors for severe infection. Unfortunately, there is still an unmet need with the currently approved antiviral due to safety concerns and drug drug interactions with commonly prescribed medications, which limit their use. We believe that the compelling profile of bemifosbuvir is differentiated because of its low risk of drug drug interaction and the absence of mutagenicity and embryo fetal toxicity in preclinical studies. Our goal for COVID-nineteen is to deliver a safe and effective treatment to the millions of patients for whom the current standard of care is not a suitable option.

Speaker 3

Moving to Slide 6. Taking into account the current COVID-nineteen environment for Sunrise 3, We are adapting the eligibility criteria for the high risk patient population, and we are also increasing the sample size to recognize the current lower rates of hospitalization and death. The modifications to our study are designed to increase the We have expanded the global footprint of Sunrise 3 And we are now targeting approximately 330 clinical trial sites in 30 countries. With COVID waves appearing sporadically and somewhat unpredictably across the world, our goal is to position ourselves best, The protocol amendment has been reviewed by the FDA, and we have started to implement these modifications. Importantly, this amendment should not change the timing guidance for the program, and we continue to anticipate top line results mid-twenty 24, And we are targeting a new drug application submission by year end 2024.

Speaker 3

Slide 7 shows a bit more detail on the latest protocol amendment modification. On the broadened patient population, We have made a number of modifications to the high risk eligibility criteria. High risk patients are now classified as being at least 70 years old, which is down from the prior 80 being at least 55 years old with a risk factor, down from 65 with a risk factor Being at least 50 years old with 2 or more risk factors, a new criterion and being at least 18 years old and immunocompromised, which is unchanged. Additionally, we've expanded the study to include patients with decreased renal function. We have addressed the lower rates of hospitalization and death by increasing the sample size to approximately 2,200 patients in the supportive care monotherapy arm and it is statistically powered to detect a clinically meaningful reduction in hospitalization or death versus

Speaker 4

Lastly, there will now be

Speaker 3

Two interim analyses for the DSMB to review in the supportive care monotherapy arm at approximately 650 and 13.50 patients, with initial top line data anticipated mid next year. Please note that the DSMB review, we do not expect to report efficacy results as these analyses are primarily geared towards safety and futility. Turning to Slide 8. We are seeing strong operational execution for Sunrise 3 from our clinical team, And we now have regulatory approvals in approximately 2 thirds of the targeted countries. Patient enrollment continues, And we believe we are well positioned to enroll patients as new variants and waves of COVID-nineteen infection continues to emerge.

Speaker 3

In summary, Sunrise 3 is focusing on the high risk patients and its primary endpoint is all cause hospitalization or death I'll now hand the call to Aruncha to review our HCV program. Aruncha? Thank you, Janet.

Speaker 4

Moving Slide 10. Let's now discuss our hepatitis C program, a combination of menifosforvirangustasvir. We believe that this combination has the potential to improve upon the current standard of care by offering a protease inhibitor free, shorter duration option for hepatitis C patients with and without cirrhosis. In June, we achieved a major milestone for this program when the first patient was dosed in our Phase II trial. There still remains an unmet need for hepatitis C patients.

Speaker 4

According to the World Health Organization, 58,000,000 people Globally, we have chronic hepatitis C infection and there are approximately 1,500,000 new infections that occur per year. Annually, we lose nearly 300,000 people to hepatitis C related liver diseases and more people continue to be infected and cured despite the availability of DAA treatment options. The CDC estimates that around 2,000,000 people in the U. S. Are infected with Hepatitis C And new infections are almost 4 times as high as they were nearly a decade ago.

Speaker 4

In addition, the reinfection rate can be in the range of 20% in people who inject drugs. We believe that there is a substantial opportunity to improve upon the current standard of care. As detailed on Slide 11, the combination of veniphosphabir and rosasvir is very potent. It has the potential to be a best in class regimen Based on its pangenotypic antiviral potency, low risk for drug drug interactions, absence of food effects and the potential for a short treatment duration. We are targeting 8 weeks of therapy and we may explore shorter duration subsequently.

Speaker 4

This profile, along with the totality of the preclinical data, gives us confidence in the potential for this combination to become the new standard of care. Recent data presented on our last earnings call, which can be found on our website, show that in vitrobeniphosphoribir is NSYB resistant associated variants or RAS. Russevier is a potent NSYB inhibitor. In a replicon assay, Rucosvir has demonstrated a more favorable in vitro profile as compared to belpatasvir and similar antiviral activity to pibrentasvir, which is the most potent and expedited data currently available. In fact, in the same Transient replicon assay, rucosvir, was shown to be 5 to 10 fold more potent than elpasvir against all rats.

Speaker 4

Again, this data can be found on our website. Slide 12 outlines our Phase 2 open label study 280 Hepatitis C Infected Antiviral naive patients across all genotypes, including a leading cohort of approximately 60 patients. Patients will be administered 550 milligrams of Benifosfravir in combination with 180 milligrams of RUSSELL BR1 daily for 8 weeks. The primary endpoint of this study are Safety and Sustained Biological Response or SVR at week 12 post treatment. Other biological endpoints include biological failure, SBI with 24 Post Treatment and Resistance.

Speaker 4

Dosing patients in this clinical trial is ongoing with Initial data from the leading cohort of approximately 60 patients anticipated around the end of this year. And with that, I will now turn the call over to our CFO, Andrea Corcoran, to summarize Atea's financial position.

Speaker 5

Thank you, Lorenza. As Jornea mentioned in her introductory remarks, earlier today we issued a press release containing our financial results for the Q2 of 2023. The statement of operations and balance sheet are on Slides 1415. For the Q2 2023, each of R and D and G and A expenses remain relatively consistent with the Q2 of 2022. As we further our clinical development of both our COVID-nineteen and HCV clinical programs in 2023, We do anticipate that R and D expenses will increase in a measured way as these programs advance.

Speaker 5

We are exercising focused financial discipline to manage spend as we invest in these programs. At the end of the Q2 of 2023, our cash, cash equivalent and marketable securities balance was $608,100,000 Based on these current plans, we are reiterating our cash guidance with a runway well into 2026. I'll now turn the call back over to Jean Pierre for closing remarks.

Speaker 2

Thank you, Andrea. In conclusion, We have already made considerable clinical and operational progress across our COVID-nineteen and HCV programs so far this year. We have also published and presented significant scientific and clinical evidence in support of the potential of our clinical programs Among an audience of leading virologists, ID specialists at several scientific conferences this year. With a number of interim analysis and data readout coming over the next year, we will continue to highlight The potential of our programs and execute on our mission to improve the treatment landscape for severe venal diseases. As always, We thank you for your continued interest and support of Atena and as together we strive to address the unmet medical needs of patients with serious viral interactions.

Speaker 2

With that, operator, we will now open the call up to your questions.

Operator

Thank you. One moment for our first question. And it comes from Maxwell Skorp with Morgan Stanley. Please proceed.

Speaker 6

Hi, team. Thank you very much for taking my question. Could you expand a bit on the expected COVID-nineteen infection rate driving your interim analysis guidance? Specifically, how is enrollment going so far? And does your guidance expect a wave in the fall?

Speaker 6

Thank you very much.

Speaker 2

Janet, you want to address that question, please?

Speaker 3

So, Enrollment, I think, is in line with the current rate of infections at the moment. And we're very pleased with the progress that we're making in And executing on our geographical footprint, so we are well positioned to take advantage of surges as they occur. And we do expect that there will likely be a surge as we move into the winter months. The infection rate It's going to be what it's going to be. It's really the hospitalization rate, which is of paramount importance to us because that's the primary endpoint obviously for the trial.

Speaker 3

I hope that answered your question. Thank you.

Speaker 6

Yes. Thank you.

Operator

Thank you. One moment for our next question. All right. It comes from the line of Umer

Speaker 7

This is Jessica on for Umer and John. Just two questions for me. So first question is by lowering the age for the SUNRISE trial, Does that mean incorporating younger slightly younger patients means healthier patients and like how would that affect the placebo arm performance? And then secondly, the previously communicated interim analysis in second half of the year presumably would have given us efficacy data. And now you're saying that interim analysis has moved to year end1Q24 and no efficacy data will be So are we only getting efficacy data for the first time in mid-twenty 24 now?

Speaker 7

Thank you.

Speaker 2

Okay. Before Janet Well, further address the question. We always gave a guidance for the end of the year, and we always indicated That it was not leading to an efficacy data analysis by the DSMB. We always indicated a guidance That it was either a safety or futility and as long as the DSMB indicated that We continued the trial. It was a positive step.

Speaker 2

So we have not changed any guidance related to release of data regarding DSMB outcome. Janet, can you address the rest, please?

Speaker 3

Thank you. Yes. So in regards to lowering

Speaker 4

the age,

Speaker 3

I don't think that in this instance younger is Healthier. What we have been experiencing is that we've actually had to exclude patients on the basis of the fact that they were too young, But actually, we're well qualified patients and potentially we're going to end up in hospital, if untreated. And so what we think is that we have actually probably enhanced our ability to enroll the study effectively By allowing in younger patients, the younger patients, as I highlighted, with risk factors and depending on the age, the number of risk factors is also contingent on that. So people 50 years and above with 2 risk factors for progression and people 55 and above with at least one risk factor for progression. And I think when you look back on the data presented by others at advisory committees and so forth, I think you'll see that this is actually a good patient population For particular risk for hospitalization.

Speaker 3

And of course, it's placebo controlled, as you mentioned. And so, it will affect both arms equally, but we're pretty confident that this ought not to force us to enroll more patients for less hospitalizations that actually allow us to do the study And then allow patients in who should actually be eligible for enrollment.

Speaker 2

And just to reemphasize, you can check Our first quarter earnings release and also our Annual Shareholder Meeting The interim analysis was expected Q4 of 'twenty three. So Q4 is part of end of the year. So We were basically a little bit more detailed here, but we have not changed any of our guidance.

Speaker 4

Does that answer the question?

Speaker 7

Yes. Sorry, I was on mute. Thank you very much.

Operator

Today comes from the line of Tim Lugo with William Blair.

Speaker 8

Hi, Tim. This is John on for Tim. Thanks so much for taking our question. Maybe just 2 from us. So first, for the HCV program, can you remind us of what data you're planning to release for the lead in cohort this year?

Speaker 8

What should we be looking for on those data? And are you planning on making any adjustments to the protocol following those results? And secondly, can you remind us of the current HCV resistance associated variance landscape? And how important is the

Speaker 2

Arrenxa, you like to address the first question, please, and then I will take the second one.

Speaker 4

Yes. So regarding the leading cohort, we are looking at safety, tolerability and efficacy as well. And that we are expecting to have that ready by around the year end.

Speaker 2

So We're going to resistance actually. We are working very hard to try to find Emerges of resistance after 16, 18 passages with Benepart Riviera is still a very difficult time To find anything that key mutation signature for bifolgravir on HCV, that's Further demonstrating a high bio resistance of this drug against HCV and I should say in the same way with other But with that said, and this is in our website, you see that As compared to Surplus Bivir, that you know is losing some GT3 potency with some Our drug basically does not dodge. So the EC90 remain exactly the same 20 nanomole, you see 50 or 2 nanomole, which is 10 to 50 times more potent Dan, sovadi, sofasbivir, regardless of BRAF and including the 282 mutation, which is The key signature for Sofaz, VIBBIA. I think by the end of the year, we will have probably A very defined molecular mechanism. It's a multi pronged as we have shown With, against coronavirus, we have some very interesting data that are confirmed now That Benifrostvivir is targeting several key molecular sites And not just chain termination, like Sofroslivia, but also other molecular sites that are critical for HCV replication.

Speaker 2

We'll Probably share we definitely will share with the Swede by the end of the year. And we are very pleased with Rusespierre When we compare the feature against Veprazolev, and we know that The breadth of the year is an excellent NS5a, but it is combined with a protease inhibitor. And we all know the issues For today's inhibitors in terms of drug drug interaction, food and back, resistance and others. So that's why we feel very strongly that We have a potential best in class regimen. And as Ernest has indicated, We feel very confident that the 8 weeks will be very effective.

Speaker 2

And then after Depending on the biokinetics, actually, I think I mentioned in previous call that Alan Pearsong With the really the leading expert on biokinetics is going to work with us and to determine if we can go even to shorter duration than 8 weeks, which will be obviously very transformational for HCV combo.

Speaker 8

Thanks so much.

Operator

Thank you. One moment for our next question. And it comes from Roan Ruiz with Leerink Partners. Please proceed.

Speaker 9

Hi, everybody. Good afternoon. This is Nick Gassik on for Roana Ruiz. Thanks for taking our questions. Maybe first On your COVID-nineteen program, I guess given the evolving landscape, what's the new bar For efficacy in the upcoming Phase III trial, what sort of reduction in hospitalizations and deaths would you consider clinically meaningful?

Speaker 9

I have a quick follow-up on the enrollment criteria.

Speaker 2

Janet, you want to take the question, please?

Speaker 3

So, yes, I think I mean, it's an interesting question. I think it needs to be clinically meaningful. And I think it's obviously also determined to some extent by the The variance of the circulating variance, and I think that has changed over time. I think just to remind you, The treatment response rate or protection against hospitalization with Paxlovid during the Omicron There in time was between 58% 78%, and we anticipate our efficacy to be

Speaker 9

Very helpful. Also, noticed that you mentioned that you're allowing enrollment of patients with decreased Renal function now, I'm curious what degree of renal impairment are you allowing? And do you anticipate Needing to modify the dose of bendafosbuvir in these patients?

Speaker 2

Janet?

Speaker 3

So we're in the process of working through our renal study, which is part of the normal NDA package. And we have now enrolled patients and established the pharmacokinetics on patients with creatinine carerances down to SUSY. And so patients who have those types of levels of renal dysfunction are eligible now to be enrolled in our trial. And looking at other nucleoside analogs that have been used for the treatment of COVID, we don't think that we're going to need to modify the dose, But we're in the process still of understanding that as we work our way through patients with further levels of renal decompensation.

Speaker 9

Got it. Thanks, Janet. One more, if I may. Thinking about your longer term plans For bendafosbuvir, what's your outlook on possible partnerships in COVID-nineteen, both in the U. S.

Speaker 9

Or maybe outside of the U. S?

Speaker 2

John, do you want to take it? And I will add a little twist after, but go ahead, John.

Speaker 10

Sure. So I think we still remain consistent in what we have been projecting and that is for ex U. S. Markets will be looking for partnerships. And for the U.

Speaker 10

S. Market, we We'll likely be looking to co promote, with an appropriate partner and those activities continue. JP?

Speaker 2

Yes. Basically, look, as you know, it's So far, the COVID market is 90% in the U. S. We have a strong balance sheet and really the rationale why We go well into 2026 and not further than that. It's because we already account for a robust launch Ourselves, if needed.

Speaker 2

So we are obviously, as Andrea indicated, very careful About our balance sheet and how we are going to spend with our programs, but in the same time, we have the muscle, Especially in the U. S, obviously, as John indicated, not outside the U. S, but especially in the U. S, we're still at 90% With $8,000,000,000 we have the muscle to go out with a very robust launch. And that's why basically you see our runway To only 3 years and not longer than that with $600,000,000

Speaker 9

Helpful. Thank you.

Operator

Thank you. And I don't see any questions in the queue. I will turn the call Back to Jean Pierre Samadelsi for his final comments.

Speaker 2

Thank you again for joining us today. Thank you.

Operator

Thank you, ladies and gentlemen. With that, we conclude today's program. You may now disconnect.

Powered by Quartr

Key Takeaways

  • FDA Fast Track designation: Bemifosbuvir received Fast Track status in Q2 for COVID-19, and Atea is on track for a Phase 3 top‐line readout mid-2024 and an NDA submission by year-end 2024.
  • Phase 3 protocol amendments: The SUNRISE 3 trial expanded high-risk eligibility (lowered age thresholds and renal impairment inclusion), increased sample size to ~2,200, and added two interim DSMB safety/futility analyses late 2023.
  • HCV Phase 2 initiation: Dosing began in June for the combination of bemifosbuvir and rucapasvir, targeting an 8-week, protease-free, pangenotypic regimen with initial data from ~60 patients expected end-2023.
  • Second‐generation protease inhibitor: A multi‐pronged COVID-19 discovery program advancing a novel protease inhibitor for potential combination therapy, with an update anticipated around year-end.
  • Strong financial position: As of Q2 2023, Atea holds $608 million in cash and equivalents, providing a runway well into 2026 while maintaining disciplined R&D and G&A spending.
A.I. generated. May contain errors.
Earnings Conference Call
Atea Pharmaceuticals Q2 2023
00:00 / 00:00