Atea Pharmaceuticals, Inc. Price & Performance (AVIR)

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.

Thank you, Jonet. Good afternoon, everyone, and thank you for joining us. I will begin on Slide three. We made significant progress last year advancing our HCV program with a regimen of Benifosbuvir and Erzasvir. In December, we reported positive results from our global Phase two trial which demonstrated a ninety eight percent cure rate in the primary efficacy analysis. With a short eight week treatment. The very high SVO rate demonstrate the robust potency across HCV genotypes. We believe our regimens, if approved, has the opportunity to become a best in class hepatitis C treatment and disrupt the global HCV market of approximately $3,000,000,000 in annual net sales. [indiscernible] helped to support a successful end of Phase two meeting with the FDA which occurred this past January. In addition, to the substantial progress that we have In addition to the substantial clinical progress Business updates include recent stat we have taken to further enhance shareholder value. This includes the retention of Evercore a global investment bank to assist us in the exploration of strategic partnership related to our Phase three HCV program. We also took cost cutting actions to enhance efficiency in the management of infrastructure expenditures which Andrea will discuss in further details.

In February, we announced the appointments of a new independent director Arthur Kirsch, who brings decades of financial and strategic advisory experience to our Board of Directors. Moving to Slide four, Based upon the encouraging results today, together with the successful outcome of the FDA meeting, we are initiating the global Phase III program evaluating regimen of benifasivir and risosivir and expect enrollment to begin [indiscernible] We believe that our Phase III program is derisked with a compelling value proposition. Furthermore, robust Phase two results for antiviral therapies of historically led to a high probability of success. In Phase three studies. In addition, we would be showing today results from a multiscale modeling approach that confirm the high likelihood of success of our Phase three program With $454,700,000.0 of cash, cash equivalents and marketable securities of December 31, 2024. Are in a strong financial position. To execute and complete our Phase three HCV program as we anticipate our cash runway will extend into 2028. Moving to Slide five. HCV's continue to be a significant global healthcare issue despite the availability of direct acting antiviral for the past decade. The unrelenting high rate of HCV infections which is outpacing the stagnant number of patients being treated underscore the need for a new differentiated and optimized therapy.

Would like to point out that we still have a very large number of untreated HCV patients of between two point four million to four million. In The United States And let's not forget that in The United States, seventy percent of liver cancer is a consequence of HCV disease progression. Therefore, the lack of treatment of these HCV patients has a profound impact not only on patients' life, but also with the associated healthcare hospitalization costs. On Slide six, the large burden of untreated HCV disease translate into a large untapped commercial opportunity. Currently in The United States, out of the one hundred and sixty thousand new infections every year only approximately one hundred hundred thousand patients are treated. Last year, for example, this U. S. Treated patients resulted in approximately $1,500,000,000 net sales and globally the market continued to approximate $3,000,000,000 We believe that the best in class profile of our regimen together with the anticipated removal of access barrier and future government initiatives can dramatically expand the number of patients in The United States from this severe viral disease. With that, I will now turn the call over to Janet to review the profile of our regimen and the global Phase III program.

Janet? [indiscernible] On Slide seven, our potential best in class regimen is the only one that combines [indiscernible] today's HCV Atea. Our regimen combines Benifosirib, which is the most potent nucleotide for HCV, yester has been developed, and Bruzovir, which is a highly potent H3D M5A inhibitor. This regimen is differentiated from the approved treatment. It offers a highly potent pan genotypic therapy with a short treatment duration along with a low potential for drug drug interaction, and can be taken with or without food All these attributes address the needs of the prescriber and the patient.

Slide eight illustrates that only our read has a preferred drug drug interaction profile. Since approximately eighty percent of HCV patients are taking concomitant medications, the drug drug interaction profile of HCV therapies is of particular importance to both patients and prescribers for ease of use.

As detailed on this slide, the regiment of Ben Fosterver and Rudersberg has the cleanest drug drug interaction profile with commonly prescribed medications such as oral contraceptives, fashions and proton pump inhibitors. On Slide 10, I'm excited to share an update for our Phase three program. In January, we had a successful end of Phase two meeting with the FDA. Following the meeting and at the request of the FDA, we submitted the final Phase three protocol which also will be submitted to other regulatory agencies.

We're currently in the process of opening up clinical sites and we're targeting over two fifty sites worldwide.

As JP stated earlier in the presentation, we're initiating the Phase three program and expect enrollment to begin in April. On Slide 11, our global HCV Phase III program consists of two randomized open label Phase three trials comparing the regimen of benifosbuvir and ruzizia to the regimen of tifosbuvir and velpasivir in patients with chronic HCV infection. Each trial will enroll approximately 800 treatment naive patients both with and without compensated ferrosio.

Patients will be stratified by genotype and cirrhosis Atea.

And the patients with HIV co infection will be allowed. For non psorotic patients, which represent more than ninety percent of patients in The U. S. Eight weeks of Benefosteir and Bruziza will be compared with twelve weeks of zafasorvir and zalpatizat.

For cirrhotic patients, twelve weeks of benifosivir and Bruzysvir will be compared with twelve weeks of cifosivir and dalpatizia.

The primary endpoint for both trials encompasses sustained virologic response, twelve weeks after treatment or FER12 in each arm and is HCV RNA less than the lower limit of quantitation twenty four weeks from the start of treatment. Measurement at twenty four weeks from the start treatment is selected to ensure the primary endpoint occurs at the same relative time point from start of treatment in all patients. Global Phase II HCV study results. Thank you, Tim.

On Slide 12, I would like to remind you that our global Phase two study was a single arm of five fifty milligrams of daily cosovir with one hundred and eighty milligrams of Russesbir once daily for eight weeks.

This Phase two trial enrolled two seventy five treatment naive patients chronically infected, which with HCV, including patients with compensated cirrhosis.

In this study, we have two efficacy populations, The primary efficacy endpoint was in the treatment at the end population.

A secondary efficacy analysis assessed SDR12 in the same population, but also included nonaviant patients. Of note, we have seventeen percent of patients who did not take the study medication or were non adherent Phase two study, and this non adherent rate is similar to what was Moving to Slide 13, the primary efficacy endpoint demonstrates a ninety eight percent SVR-twelve Atea in all adhering patients after eight weeks of treatment.

And a ninety five percent SVR12 rate was achieved in patients regardless of treatment at year end. This patient population also included Atea point six patients where the SVR12 was eighty eight percent. In this cirrhotic Atea, on treatment viral kinetics was slower but it is important to note that 100% viral clearance was achieved at the end of treatment.

Therefore, we can expect twelve weeks of treatment in cirrhotic patients should lead to very high 14 shows that the overall noncyrotic treatment adherence population 100%, with only one failure in one hundred and seventy nine patients, In Dino Peak III, it was one hundred percent which is a Genopec historically hard to treat.

The robust potency and drug forgiveness was demonstrated with the regimen achieving ninety seven percent SDR12 in the overall population and ninety eight percent in Genopel III. Even with twenty percent of these patients being non adherent.

On Slide 15, the retinue of benifosabir and russesbir was generally safe and well tolerated with no drug related severe adverse events or premature treatment discontinuations Atea.

Similarly, there were no trends observed in adverse events or safety laboratory parameters. Let's now review new modeling data on Slide 16. The Phase two data was further evaluated in a multiscale model of infection and treatment to confirm the effectiveness of benifosorbir and rosuzevir.

A similar approach has been previously validated and published to evaluate other DAA regimens against HCV. In this model, the population estimate for the time to achieve hcvRNA less than the lower limit of quantification in the plasma was approximately twelve to sixteen days while the corresponding time to achieve cure was approximately seven to eight weeks. Therefore, this model provides further support for a high likelihood of success for the regimen being evaluated in Phase three. With durations of eight weeks in non cirrhotic patients and twelve weeks in cirrhotic patients. I will now turn the call over to Andrea to discuss Athea's financials. Thank you, Orensa.

As Jernay mentioned, earlier today, we issued press release containing our financial results for the fourth quarter and full year 2020 The statement of operations and balance sheet can be found on Slides eighteen and nineteen. In 2024, R and D expenses declined quarter over quarter, but increased year over year in 2024.

The full year increase was primarily driven by higher 2024 external spend related to our COVID-nineteen Phase three Sunrise three trial as well as our Phase II HCV trial. For G and A, expenses in 2024 and 2023 were similar quarter over quarter and year over year. Interest income quarter over quarter and year over year decreased due to lower investment balances. 2025, substantially all our external R and D spend will be related to the advancement of our Phase three program. As Jean Pierre mentioned, at year end 2024, our cash, cash equivalents and marketable securities balance was $454,700,000 Continuing our strong financial discipline, we project cash guidance runway into 2028.

Moving to Slide 20. As noted in our press release today, we announced a reduction of our workforce by approximately 20%, 25% in early January. This action is intended to enhance efficiency in the management of and is expected to reallocate in a cost savings of approximately $15,000,000 through 2027. Additionally, we also announced that Arthur Kirsch has joined our Board of Directors. His extensive financial and strategic advisory experience will further strengthen the Atea Board as we advance our strategic priorities. We believe that Arthur's proven track record of executing and overseeing transactions will be invaluable as we pursue opportunities to enhance shareholder value. I'll now turn the call back over to Jean Pierre for closing remarks.

Thank you, Andrea. In Cozinc, we believe that our global Phase three HCV program is derisked with a high compelling value proposition. This is based on substantial preclinical and mostly clinical data a well characterized regulatory pathway, optimized manufacturing processes, a durable multi billion dollar market [indiscernible] We believe that the regiment of Benyfosbury and Resensville with this potential best in class profile for the treatment of hepatitis C if approved provide an opportunity to become the most prescribed treatment and disrupt the global hepatitis C market of approximately $3,000,000,000 in annual net sales.

Before opening the call to your questions, I would like to thank our talented and dedicated [indiscernible] Our team at Drentis pursuit of excellence drive our dedication to advancing oral antiviral therapeutics for patients worldwide affected by severe viral diseases. With that, I would turn the call back over to the operator.

Thank you.

And our first question comes from the line of Bella Kamant, with JPMorgan. Your line is open. Please go ahead.

Hi. This is Bella on for Eric. Just two questions from us here. First, following your meeting with the FDA, are there any specific callouts that they've guided for in the Phase three trial design? And then second, what can we expect in terms of the scope of your Phase two readout later this half?

Janet, you want to address the first one and then Renza will address the second questions? [indiscernible] So with regards to our meeting with the FDA, no, I don't think really any specific callouts. They are fully aligned with our approach of going forward with two open label Phase three trials think it's somewhat unconventional to run open label trials, but I think given the circumstances, of the different properties of the drugs in the population that we're studying, this is completely in agreement with them and they didn't really have any substantive comments around the conduct of the trial. Yes. I think the question, Sandela, was about the Phase two readouts So we're expecting to present data this summer at East Solis in May. And so you'll have additional data there in terms of the infill from safety, and all the other details of the protocol of the study.

Great. Thank you.

Thank you. And one moment for our next question. Our next question comes from the line of Andy Atea with William Blair. Your line is open. Please go ahead.

Great.

Three questions from us, if you don't mind. One is on the trial design for the Phase three program. I'm curious you have an estimated number of cirrhotic patients across those two trials Are they going to be strictly controlled or this is kind of an estimation based on global and U. S. Epidemiology? That's question number one. [indiscernible] one question at a time, if you don't mind. So Janet, you address the first question, please? So yes, so there are estimates We have target numbers of of cirrhotic patients that we'd like to see enroll in the trial. But the number of cirrhotic patients, I think, generally worldwide has declined with the advent of direct acting antiviral therapies. I think particularly so in The U. S. That are harder to find than I think they were earlier direct acting antiviral trials were conducted.

But we do anticipate seeing somewhere in the order of just north of ten percent probably in our trial, and that's what we're aiming for.

I see. Is there an ability for you to adjust that number, if you're seeing maybe a little bit lower or higher as the trial is enrolling?

Yes, I think so. As I said, we're having we're setting targets, not absolute numbers. So we do have some flexibility in there. And obviously, if we can achieve more and get greater experience, I think that will be important. But I don't think there are absolute requirements around that. We want to have sufficient patients enrolled with Sverzys to be able to justify having that population in our label. But I think we're certainly going to do the best we can to have enough But there is flexibility there.

That's helpful. Second question has to do with the modeling which is very unique on Slide 16. So I'm curious if you were to plot this with EPCUSA, would you expect that that those two lines to be right shifted for [indiscernible] Developed by Doctor. Alan Pelson.

From Los Alamos and please check there is publications with other antiviral direct antiviral for HCV Atea.

Okay. Okay. Okay. That's helpful. Okay. That's actually so sorry for the the confusion. There's just two questions from us, but thanks for your input.

You're very welcome. Thank you for the questions.

I'm showing no further questions. And I would like to hand the conference back over to Jean Pierre for closing remarks.

Thank you for all of you for joining our fourth quarter twenty twenty four earnings conference call. And thank you for your continued support. Thank you.