Atea Pharmaceuticals Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: We initiated patient dosing in two global Phase III trials (C BEYOND and C FORWARD) of our Benifosbuvir-Ruzasivir regimen and remain on track for mid-2026 topline results.
  • Positive Sentiment: Phase II global data demonstrated a 98% SVR12 rate with an eight-week treatment, showing robust pan-genotypic potency and high tolerance, including in genotype 3 and cirrhotic patients.
  • Positive Sentiment: As of June 30, 2025, we held $379.7 million in cash and marketable securities, providing a runway through 2027 to complete our global HCV program.
  • Positive Sentiment: We launched a share repurchase program of up to $25 million and have already retired 4.6 million shares, underlining our commitment to returning capital and enhancing shareholder value.
  • Positive Sentiment: The global HCV market remains large and under-served—with an estimated 2.4–4 million untreated U.S. patients and rising incidence—highlighting significant commercial opportunity for our optimized regimen.
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Earnings Conference Call
Atea Pharmaceuticals Q2 2025
00:00 / 00:00

There are 7 speakers on the call.

Operator

Good afternoon, and welcome to the Atea Pharmaceuticals Second Quarter twenty twenty five Earnings Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Janae Barnes, Senior Vice President, Investor Relations and Corporate Communications. Please go ahead.

Speaker 1

Great. Thank you, and good afternoon, everyone, and welcome to Ateia Pharmaceuticals' Second Quarter twenty twenty five 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 atayapharma.com. With me today from ATEA are our Chief Executive Officer and Founder, Doctor.

Speaker 1

John Pierre Somedosi Chief Development Officer, Doctor. Janet Hammond John Van Vrika, our Chief Commercial Officer Doctor. Ransha Hourga, our Chief Medical Officer and Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, all of whom will be available for the Q and A portion of today's call. Before we begin the call, and as outlined on slide two, I would like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read.

Speaker 1

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, Jeanne. Good afternoon, everyone. Thank you for joining us. I will begin on slide three. For the second quarter, we have several clinical and business highlights to review.

Speaker 2

We made important progress in our HCV program, evaluating the potential best in class regimen of Benifaziri and Ruzaziri. We started dosing patients in our global Phase three development program, which is comprised of the two trial, C Beyond in The US and Canada and Sea Forward outside of North America. At EASL in May, we presented the final results from our global Phase two trial. These results demonstrated a ninety eight percent pure rate in the primary efficacy analysis with a short eight week treatment. The very high sustained biological response, which we refer as SVR for pure rates demonstrated the robust potency across HCV genotypes.

Speaker 2

We also presented three phase one studies, and Arrenso will review the highlights of this presentation in a few moments. Also in May, we also had a opinion leader event for investors featuring a panel of six HCV experts and prescribers. Leaders in hepatology, gastroenterology, infectious disease, and HCV research in The US, Canada, and Europe discussed the current challenges experienced by people living with HCV and what a new optimized HCV therapy could provide for prescriber and patients. Janet will review the key takeaway from this event later in this call. In addition to this substantial clinical progress, we have taken steps to further enhance shareholder value.

Speaker 2

In April, we announced the repurchase of up to $25,000,000 of the company common stock, reflecting the company commitment to return capital to shareholders while maintaining the capacity to complete the global Phase three HCV program and position Ateya for long term success. We also announced the addition of a new independent director, Doctor. Howard Berman, who has over twenty years of entrepreneurial and life science industry experience. We continue as well to explore potential opportunities to enhance shareholder values. Moving to Slide four, it has been nearly a decade since the last generation of HCV therapy became available to patients.

Speaker 2

Since then, patients and the treatment needs have evolved and we are focused on the successful development of a potential best in class regimen to treat and cure today's HCV patients. During the second quarter, we continue to advance our global Phase three HCV program evaluating the regimen of Benifazri and Aritzelzia. The patient enrollment is on track and I'm pleased to share with you tonight. And we anticipate top line results from C BEYOND in mid-twenty twenty six and C Forward at the 2026, which is due to longer timelines outside of North America for regulatory approvals of clinical trials. Our regimen, if approved, has the potential to become a best in class HCV treatment and disrupt the global HCV market, which is approximately $3,000,000,000 in annual net sales.

Speaker 2

With $379,700,000 in cash, cash equivalent and marketable securities as of 06/30/2025, we are in the strong financial position to execute and complete our Phase three HCV program. And we anticipate our cash runway would extend through 2027. Moving to Slide five, HCV remains a significant global healthcare issue with an increasing incidence of infections despite the availability of direct acting antiviral for the past decade. Currently in The US, out of the one hundred and seventy thousand new infections, only approximately one hundred thousand patients are treated annually. The unrelenting high rate of HCV infection, which is outpacing the stagnant number of patients being treated underscore the need for new differentiated and optimized therapy.

Speaker 2

There are between two point four and four million untreated people infected with HCV in The United States, and let's not forget that in The U. S. As in developed countries, seventy percent of liver cancer diagnosis results from HCV disease progression. Therefore, low treatment and cure rates for HCV patients have a profound impact not only on patients' lives, but also on the associated healthcare costs in the near future. On slide six, the large burden of untreated HCV disease is also a large untapped commercial opportunity.

Speaker 2

We believe that the best in class profile of our regimen, which is particularly well suited for a new model of care, which we call test and treat with similar diagnosis and treatment for patients infected with HCV, the anticipated removal of access buyer, and future government initiative we see today, arising from, the hill can dramatically expand the number of patients cure of this severe viral disease. With that, I would now turn the call over to Arrensa Olga, who will review the presentations at EASL and our Phase III program. Erenica?

Speaker 3

Thank you, Jean Pierre. Let's move to slide eight. In May, at the European Association for the Study of the Liver Congress, or EASL, four ATEIA posters were presented. They included the results from the full cohort of patients enrolled in the Phase II study evaluating the regimen of benifosbuvir and russelvir for HCV, which are highlighted in the coming slides. In addition, results from three additional Phase I studies demonstrated that the combination of benifosbuvir and russelvir had a low risk of drug drug interactions.

Speaker 3

These results support the use of the regimen in HCV patients coinfected with HIV taking a standard HIV treatment. Also presented was the PK and safety of benifosbuvir in participants with hepatic or renal impairment, showing no need for dose adjustments. The ESOL posters presented can be accessed on the ATEA website in the publications section. Let's now review the highlights from the phase two results. On slide nine, to the left, you will see the overview of our global phase two study, which was a single arm trial of five fifty milligrams of benifosfavir with one hundred and eighty milligrams of russevir once daily for eight weeks.

Speaker 3

We enrolled two seventy five treatment naive patients chronically infected with HCV, including patients with compensated cirrhosis. In the study, we evaluated two efficacy populations. The primary efficacy endpoint was in the treatment adherent population. A secondary efficacy analysis assessed SVR12 in the same population, but it also included non adherent patients. To the right, the primary efficacy endpoint demonstrates a ninety eight percent SVR12 rate in all adherent patients after eight weeks of treatment, and a ninety five percent SVR12 rate was achieved in patients regardless of treatment adherence, with twenty percent of these patients being nonadherent.

Speaker 3

Slide 10 shows that in the overall nonheroic treatment adherent population, SVR12 was almost one hundred percent with only one failure out of one hundred and seventy nine patients. In genotype three, SVR12 was one hundred percent, which is a genotype that is historically hard to treat. The robust potency and drug forgiveness was demonstrated in non cirrhotic patients regardless of drug adherence with the regimen achieving ninety seven percent FVR12 in the overall population and ninety eight percent in Genotype three. The regimen was generally safe and well tolerated with no drug related severe adverse events or premature treatment discontinuations. Similarly, there were no trends observed in adverse events or safety laboratory parameters.

Speaker 3

On slide 12 is an overview of ATEA's global HCV Phase three program, which includes two open label Phase three trials, C BEYOND and C FORWARD. Each Phase three trial is enrolling approximately eight eighty treatment naive patients, including those with and without compensated cirrhosis. The trials will compare the fixed dose combination regimen of benifosbuvir and rusasvir to the fixed dose regimen of sofosbuvir and delpasvir, also known as Epclusa. Our two pill regimen will be administered orally once daily for eight weeks in noncerebotic patients or twelve weeks in patients with compensated cirrhosis, while sofosbuvir and belpatasvir will be administered orally once daily for twelve weeks to all patients with or without compensated cirrhosis. The primary endpoint measures cure by using the regulatory approved endpoint of SVR12.

Speaker 3

Measurement occurs at twenty four weeks from the start of treatment to ensure the primary endpoint occurs at the same relative time point for all patients. As Jean Pierre mentioned earlier, patient enrollment is on track. Slide 13 shows the geographic footprint for C BEYOND with approximately 120 clinical sites in The US and Canada. For C FORWARD, we're targeting approximately 120 clinical sites in 16 countries outside of North America. I will now hand the call over to Janet Hammond to review our recent KOL event and the profile of our regimen.

Speaker 3

Janet? Thank you, Arundra. Good afternoon, everybody. Let's now move to slide 15. Following EASL, Atair held a hepatitis C key opinion leader event that featured a panel of six leaders in hepatology, gastroenterology, infectious disease, and HCV research from The US, Canada, and Europe.

Speaker 3

During the panel discussion, these experts discussed the current challenges encountered by patients with hepatitis C and their providers and what a new optimized hepatitis C therapy could offer. In addition, the results from ATEA's global phase two study evaluating the regimen of benifrostavir and ruzazir for the treatment of hepatitis C were presented by Doctor. Eric Lawitz from the Texas Liver Institute, University of Texas Health San Antonio, who was an investigator in the phase two study and is also an investigator in the phase three CBON trial. On slide 16, you will see some of the key takeaways from the panel discussion. Please note that the panel discussion replay information is also available on these slides.

Speaker 3

The key opinion leaders noted that the incidence of hepatitis C has not slowed down even with available existing direct acting antiviral treatments available. In 2015 there were approximately two point five million people infected in The United States and it is now estimated to be upwards of approximately four million. The key opinion leaders discussed the evolution in the profile of patients infected with hepatitis C today. Generally patients now are younger and more medically complex. There has been a shift to younger patients who inject drugs with associated risks of transmission, and this problem is only getting worse.

Speaker 3

Today, frequently, patients are also on multiple concomitant medications. Today's patients and healthcare providers want simplicity from their treatment options, including short durations of treatment that are optimized while minimizing interactions with concurrent medications. In addition, the test and treat model of care, which enables seamless diagnosis and treatment for patients infected with hepatitis C, was discussed by the key opinion leaders as a necessary change to meaningfully advance the eradication of hepatitis C. The KOL further stated that neither currently approved regimen is perfect and there is a need for a new optimized treatment. Let's now move to slide 17 and review the target profile of our potential best in class regimen.

Speaker 3

It's the only regimen that combines the required attributes to successfully treat today's patients. Our regimen combines benefosvia, which is the most potent nucleotide for hepatitis C yet to have been developed, and ruzazir, which is a highly potent HCV NS5A inhibitor. This regimen is significantly 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 interactions, and can be taken with or without food. All these attributes address the needs of both prescriber and the patient.

Speaker 3

Slide 18. Our regimen has a low risk for drug interaction profile. Since approximately eighty percent of hepatitis C patients are taking concomitant medications, the 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 regimen of benifrostavir and ruzovir has a very keen drug interaction profile with commonly prescribed medications such as oral contraceptives, statins and proton pump inhibitors. With that, I'll now turn the call over to John Vabrika to review new results from market research.

Speaker 3

John?

Speaker 4

Thank you Janet. On slide 20, following the Phase two clinical results, we conducted a quantitative market research study of high U. S. DAA prescribers. IQVIA selected the study participants and conducted the market research.

Speaker 4

153 top U. S. DAA prescribers reviewed the BAM RZR profile, including the Phase two results on their own prior to assessing their likely prescribing. The study revealed high preference for BEM RZR with seventy six percent extremely likely to prescribe our regimen. When asked about the percentage of their patients they would likely prescribe BEM RZR to, the study showed that BEM RZR would be used in approximately half their patients.

Speaker 4

The results were similar for both noncirrhotic and compensated cirrhotic patients. Moving on to slide 21, I would like to highlight that these latest quantitative market research results conducted following the Banner ZR Phase two results are consistent with the previous quantitative market research conducted over the past two years. The three market research studies consistently show significant preference for with high USDA prescribers. I'll now turn the call over to Andrea to discuss the TAEUS financials. Andrea?

Speaker 5

Thank you, John. As Jornay mentioned, earlier today we issued a press release containing our financial results for the 2025. The statement of operation and balance sheet are on slides twenty three and twenty four. In the 2025, R and D expenses decreased compared to the same period in 2024. In Q2 twenty twenty four, we were still conducting our phase three SUNRISE three trial before it concluded later in the 2024 year.

Speaker 5

For G and A expenses, in comparison to second quarter twenty twenty four gs and A expenses, our 2025 gs and A expenses decreased primarily as a result of lower stock based compensation and payroll expenses. Interest income in Q2 twenty twenty five was lower than the 2024 due to lower investment balances. For the remainder of 'twenty five, we expect our R and D expenditures will be principally invested in the conduct of our global Phase III HCV program. As Jean Pierre mentioned at the end of the second quarter, our cash, cash equivalent and marketable securities balance was $379,700,000 Continuing our strong financial discipline, we project this cash guidance runway through 2027. Turning to slide '25, I would like to now review certain Q2 business and organizational highlights.

Speaker 5

In April, we announced the repurchase of up to $25,000,000 of the company's common stock. This initiative reflects the company's commitment to return capital to shareholders while maintaining the capacity to complete its global Phase III HCV program and to position ATEA for long term success. As of June 30, we had repurchased and retired 4,600,000.0 shares of ATEA common stock. During Q2, we also announced the refreshment of our board with the addition of Doctor. Howard Berman as an independent director.

Speaker 5

Doctor. Berman has over twenty years of entrepreneurial and life science industry experience working at the interplay of science and business. I'll now hand the call back to Jean Pierre for closing remarks.

Speaker 2

Thank you, Andrea. In closing, we believe that our global Phase three HCV program is derisked with a highly compelling value proposition. This is based on substantial preclinical and clinical data, a well characterized regulatory pathway, optimized manufacturing processes, a durable multibillion dollar market, and a long patent runway. We believe that the regimen of Benifosiran and Rizazvir with its potential best in class profile for the treatment of HCV, if approved, provides an opportunity to become the most prescribed treatment, disrupting and expanding the current global HCV 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 Altea employees.

Speaker 2

Our team relentless pursuit of excellence drives our dedication to advancing all antiviral therapeutics for patients worldwide affected by severe viral disease. With that, I will turn the call back over to the operator.

Operator

We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster.

Operator

The first question comes from Andy Hsieh with William Blair. Please go ahead.

Speaker 6

Hi, this is Kelsey Lucerne, William Blair, on for Andy Hsieh. Thanks for taking my question. Very curious, could you provide an update on how enrollment is progressing in the Phase III C Beyond and C Forward trials, and what kind of feedback or enthusiasm you might be hearing from investigators so far? Thanks.

Speaker 2

Arrenza?

Speaker 3

Yes, thank you for the question. So, enrollment is progressing on track. CBEYOND, in particular is, as you know, moving a little faster because the regulatory approvals faster in North America as compared to cForward where the regulatory approvals take longer in a lot of these countries. But in both cases, it's on track. And in terms of the investigator enthusiasm, I have to say that, you know, having done this for many years now, studies that are enrolled that enroll on track and are doing well with enrollment always reflect keen interest from the investigators and a very nice value proposition for the patients.

Speaker 3

That's why they sign up and that's why you enroll and you're not behind. So, I think our enrollment is reflecting exactly that, the enthusiasm from investigators and from the patients.

Operator

And did you have a follow-up question?

Speaker 6

No, thank you so much. Appreciate it.

Speaker 2

Thank you.

Operator

This concludes our question and answer session. I would like to turn the conference back over to JP Somodosi for any closing remarks.

Speaker 2

Thank you all for joining our second quarter earnings conference call, and thank you again for your continuous support.

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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