아테아 파마슈티컬스(AVIR) 2026년 2분기 실적 발표회: C-BEYOND 임상 3상 평가변수 충족

핵심 요약

• 아티아 파마슈티컬스(Atea Pharmaceuticals)의 임상 3상 C-BEYOND 임상시험이 1차 평가변수를 충족했다. 벰니포스부비르/루자스비르(bemnifosbuvir/ruzasvir) 병용요법은 수정된 치료의도 분석군(mITT)에서 93.9%의 지속적 바이러스 반응률(SVR)을 기록해, 소포스부비르/벨파타스비르(sofosbuvir/velpatasvir)의 94.8% 대비 사전 설정된 5% 비열등성 마진을 충족했다.
• 비간경변증 환자군에서 해당 병용요법은 8주 투여 후 93.5%의 반응률을 보여, 소포스부비르/벨파타스비르 12주 투여군의 94.6%와 비교되었다. 보상성 간경변증 환자군에서는 두 12주 투여군 모두 95.4%를 기록했다.
• 환자 등록이 완료된 C-FORWARD 임상 3상에는 북미 이외 지역의 환자 880명 이상이 포함되어 있다. 탑라인 결과는 2027년 1분기 초에 발표될 예정이며, 결과가 긍정적일 경우 2027년 2분기에 신약허가신청(NDA) 제출이 이루어질 것으로 예상된다.
• 2026년 6월 30일 기준 현금 및 매도가능증권은 총 2억 1,950만 달러다. 경영진은 회사의 현금 확보 기간(runway)이 2027년까지 이어질 것으로 예상하고 있다.
• 아티아는 지난 7월 만성 E형 간염 치료제 AT-587의 최초 인체 대상 임상 1상을 시작했다. 첫 번째 코호트 투약이 완료되었으며, 연구는 다음 코호트로 진행 중이다.
• 경영진은 벰니포스부비르/루자스비르의 미국 내 연간 최대 순매출 잠재력을 7억 달러 이상으로 추정하며, 성공적인 개발 및 규제 당국의 승인을 전제로 2028년 중반 출시를 전망하고 있다.

핵심 재무 데이터

사업 및 경영 성과

C-BEYOND 임상은 미국과 캐나다의 약 120개 기관에서 표준 치료법인 소포스부비르/벨파타스비르 병용요법 대비 벰니포스부비르/루자스비르를 평가했다. 연구 대상에는 임상적으로 복잡한 환자군이 포함되었다. 89%가 병용 약물을 복용 중이었고, 3분의 2가 정신 질환을 앓고 있었으며, 절반 이상이 주사제 약물 오남용을 HCV 감염 경로로 보고했다. 10% 이상이 치료를 조기 중단하거나 추적 관찰에서 누락되었으며, 프로토콜을 준수하지 않았다.

경영진에 따르면, 투여군 간 안전성은 유사한 수준이었다. 치료 후 발생한 이상사례(TEAE)의 대부분은 경증에서 중등증이었다. 임상시험용 약물로 인한 중대한 이상사례나 조기 투약 중단은 보고되지 않았다. 벰니포스부비르/루자스비르 투여군에서는 사망 사례가 없었으며, 대조군에서는 3명의 사망 사례가 발생했으나 모두 치료와 관련이 없는 것으로 간주되었다.

경영진은 벰니포스부비르/루자스비르를 비간경변증 환자를 위한 8주 치료 과정의 잠재적 범유전자형(pangenotypic), 단백질 분해효소 억제제 미포함 치료법으로 자리매김하고 있다. 이는 약물 간 상호작용 가능성이 제한적이고 음식물에 의한 영향이 없다. 회사는 이러한 특성이 다제복용 환자 및 새롭게 부상하는 '진단 후 즉시 치료(test-and-treat)' 케어 모델 내 활용을 뒷받침할 수 있다고 밝혔다.

C-FORWARD 임상은 HCV 유전자형 1b, 3, 4, 5, 6형 환자 비중을 높여 구성되었다. 경영진은 이번 연구를 통해 보다 광범위한 유전자형 구성에 걸쳐 확증적인 유효성 데이터를 확보하고 글로벌 규제 제출 패키지를 지원할 수 있을 것으로 기대하고 있다.

AT-587의 경우, 임상 1상에서 단일용량 증량(SAD) 및 다중용량 증량(MAD) 단계를 통해 건강한 자원자를 대상으로 안전성, 내약성, 약동학을 평가하고 있으며 음식물 영향 평가도 포함되어 있다. 아티아는 만성 E형 간염을 승인된 치료제가 없는 분야로 설명했다.

경영진 가이던스

경영진은 2027년 1분기 초에 C-FORWARD 탑라인 데이터가 나올 것으로 예상한다. 긍정적인 결과가 나올 경우, 아티아는 2027년 2분기에 신약허가신청(NDA)을 제출할 것으로 전망하고 있다.

회사는 E형 간염 프로그램이 2027년에 개념 검증(proof of concept) 단계로 진척될 것으로 기대하고 있다. 단기 지출의 대부분은 C-FORWARD 임상 완료, 규제당국 제출 준비 및 HCV 출시 전 지원 활동에 계속 집중될 예정이다.

아티아는 현금 소진 시점을 2027년까지로 전망하고 있다. 경영진은 또한 성공적인 임상, 허가 및 상업화 실행을 전제로 2028년 중반 HCV 치료제 출시와 이후 빠른 수익성 달성을 예상하고 있다.

상업적 측면에서 경영진은 미국 내 연간 최대 순매출을 7억 달러 이상으로 추정한다. 회사는 2025년 미국 HCV 순매출이 13억 달러, 글로벌 순매출이 26억 달러에 달했다고 언급하면서, 차별화된 치료제가 미국 연간 시장을 최대 25억 달러까지 확대할 수 있을 것으로 추정했다. 이러한 수치는 아티아의 실현된 매출이 아니라 경영진의 시장 가정을 나타낸다.

리스크 및 주시 사항

• 계획된 2027년 2분기 NDA 제출은 C-FORWARD의 긍정적인 결과에 달려 있다. 이 임상은 C-BEYOND보다 다양한 지역과 더 광범위한 유전자형 구성을 포함한다.
• 실제 의료 현장(Real-world)에서의 복약 순응도는 여전히 주요 과제로 남아 있다. C-BEYOND 참가자의 10% 이상이 조기 중단했거나, 추적 관찰에서 누락되었거나, 복약 수칙을 준수하지 않았다.
• '진단 후 즉시 치료(test-and-treat)' 실행은 보험 지불자(payer) 규정, 조제 프로세스, 그리고 환자가 추가 처방전 재발급(refill) 없이 전체 치료 과정을 전달받을 수 있는지 여부에 일부 의존한다.
• 메디케어 파트 D, 메디케이드 약가 정책 및 가능성 있는 340B 제도 변경은 순가격 및 리베이트에 영향을 미칠 수 있다. 경영진은 최종적인 영향은 정책 변화가 어떻게 시행되는지에 따라 결정될 것이라고 밝혔다.
• 간소화된 HCV 치료 알고리즘에의 포함은 규제 당국의 승인 및 향후 가이드라인 검토를 거쳐 이루어질 예정이다.

애널리스트 Q&A 하이라이트

경영진은 학술대회에서 해당 병용요법의 제안된 조립 방해(assembly-disruption) 기전에 관한 추가 데이터를 발표하고 2027년 초 FDA와 전체 데이터셋을 논의할 계획이라고 밝혔다. 회사는 잠재적 적응증/라벨링에 대한 세부 사항은 더 이상 제공하지 않았다.

C-FORWARD와 관련하여 경영진은 주로 유전자형 1a형 중심인 미국 환자군에 비해 미국 외 환자군에는 유전자형 1b형과 희귀 유전자형이 더 많이 포함될 것이라고 언급했다. 또한 주사제 약물 오남용 관련 감염 비율이 더 낮고 복약 순응도가 개선될 잠재력이 있을 것으로 기대하나, 이는 결과를 앞둔 시점에서의 예상 수준이라고 덧붙였다.

회사는 C-FORWARD가 규제 기관별로 사실상 별도의 1차 평가변수를 갖고 있다고 설명했다. 유럽의약품청(EMA)의 경우 프로토콜 준수 분석군(per-protocol)을, 미국 식품의약국(FDA)의 경우 수정된 치료의도 분석군(mITT)을 적용한다.

상업화와 관련해 아티아는 병 및 4주 분량의 블리스터 팩 포장을 사용할 계획이다. 경영진은 미국 내 HCV 처방자 기반이 집중되어 있어 약 7,800명의 의사가 직접작용 항바이러스제(DAA) 처방의 약 80%를 차지하며, 이에 따라 약 75~100명 규모의 전문 상업화 조직을 통해 커버리지가 가능할 것으로 예상했다.

실적 발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Thank you. Good afternoon everyone and welcome to the Atea Pharmaceuticals second quarter 2026 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 Jonay Barnes, Senior Vice President of Investor Relations and Corporate Communications at Attea Pharmaceuticals. Ms. Barnes, please proceed.

Jonae Barnes

Thank you, operator. Good afternoon, everyone, and welcome to ATAEA Pharmaceutical's second quarter, twenty twenty six financial results and business update conference call. Earlier today, we issued a press release, which outlined the topics we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by going to the investor section of our website. at ir.ateafarma.com. With me from Atea are our Chief Executive Officer and Founder Dr. Jean-Pierre Samadossi, Chief Development Officer Dr. Janet Hammond, Chief Commercial Officer John Vavrica, Chief Medical Officer Dr. Arantxa Horga, Chief Financial Officer and Executive Vice President legal, Andrea Corcoran, who will 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 risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Security. 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.

Jean-Pierre Sommadossi

Thank you, Jonay. Good afternoon, everyone, and thank you for joining us. I will begin on slide three. The positive top line results from C-Beyond, our phase three trial evaluating the combination of BAM and Rizosvir for the treatment of hepatitis C in North America represent a significant milestone for Atea and for the millions of people living with hepatitis C we need a shorter, simpler path to cure. We were very pleased that C.B. Young met both his primary and secondary endpoints with bam-rusosver demonstrating statistical non-inferiority to abclusa, the current standard of care. Importantly, this was the first success phase three trial in the global head-to-head HCV program. achieved in the real world patient population that was polymedicated, Psychiatrically complex, substance abuse affected, adherence challenge. These results reinforce the need for a best-in-class profile designed for the broad and complex hepatitis C population clinicians treat today.

The Ransom will review in detail the results of the trial. See for our second phase three trial. being conducted outside North America, is fully enrolled with more than 880 patients, and we remain on track to report top-line results in early Q1, 2027. We believe that the C4WAT dataset will provide important confirmatory efficacy data across a broader range of genotypes, and strengthen the pen-genotypic regulatory package for Ben-Muzazril. In July, we also initiated our first in human phase one clinical trial of AT587, our potential first in class direct acting antiviral for chronic hepatitis E, a serious disease with no approved treatment. therapy today. This milestone reflects the continued advancement of our all-direct acting antiviral pipeline. We remain in the solid financial position with $219.5 million in cash and money. marketable securities as of June 30th, 2026, with our cash runway anticipated through 2027. I will now hand the call over to Arantza, our chief medical officer, to review our phase three program.

Unknown Speaker

Thank you, Jean-Pierre. Good afternoon, everyone. Moving to slide five, See Beyond was a randomized active control non-inferiority trial against the phosphovir-belbatavir marketed as Eclusa, a standard of care regimen. The trial involved patients with chronic HCV, at approximately 120 clinical sites in the U.S. and Canada, including patients co-infected with HIV and patients across the HCV genotypes that predominate in North America. Patients without cirrhosis received benrucesvir for 8 weeks or softvel for 12 weeks. Patients with compensated cirrhosis received 12 weeks of treatment with either regimen. On slide 6, let's now review the C. b. young endpoints and patient populations. The primary efficacy endpoint is SBR or CURE at week 24, assessing the modified intent to treat or MITT population, which was agreed upon with the FDA.

This population includes all patients who received at least one dose of the regimen, including those who discontinued early, were not compliant, or were lost to follow-up. The trial is powered at 90% with a 5% non-inferiority margin. CBIOM is the anchor trial for the USMDA submission. Moving to slide seven, you can see that the baseline characteristics of the patients in C-Beyond were very well balanced across the two arms, including age, sex, BMI, race and ethnicity, status, viral load, and HIV co-infection. On slide eight, see beyond and world the HCV population clinicians are treating in North America today. which looks meaningfully different from the population studied a decade ago. In our trial, more than half of the patients reported injection drug use as the root of HCV transmission. Approximately 89% were taking concomitant medications, two-thirds had a psychiatry disorder, and over 10% prematurely discontinued treatment were lost to follow-up or were not adherent to the protocol.

Current standard of care regimens have challenges where it matters most. moderate proteins inhibitor containing regimen carries DDI limitations that restrict or complicate use in many of these patients while ECLUSAR requires 12 weeks of treatment. In our market research, only 6% of 157 high-prescribing U.S. physicians reported no unmet need, with physicians continuing to cite key priorities such as shorter duration, high efficacy, and fewer contraindications. Let's now review the Phase III results on slide 9. In the primary endpoint MITT population, Bem-Russevier achieved a 93.9% SBR rate compared with 94.8% for soft VEL at week 24, encompassing SBR 12, the accepted definition of cure for HCV. This result met the primary endpoint of statistical non-inferiority within the pre-specified 5% margin. Roots Severe deliver cure rates comparable to the standard of care while offering an 8-week regimen for non-cirrhotic patients compared to 12 weeks for soft bell. On slide 10, in the non-cirrhotic MITT population, BEM-RUSSOSVIR exceeds a 93.5% SVR rate with eight weeks of treatment, compared with 94.6% for SOFVEL with 12 weeks of treatment. in patients with compensated cirrhosis, both arms achieved a 95.4% FVR rate with 12 weeks of treatment. populations are not powered for statistical analysis.

On slide 11 is the the safety summary. Overall adverse events were comparable between the two treatment arms. Most treatment emergency events were mild to moderate and balanced between treatment arms. There were no serious adverse events due to the study drugs and while there were no deaths in the Ben Rousseff arm, three deaths in the South Bell arm were observed, but not related to the study drug. Similarly, there were no early treatment discontinuations related to the study drugs. Moving to slide 12, real-world adherence and discontinuation of treatment with loss to follow-up remains a major barrier in HCV treatment today and helps explain why current SDR rates with approved therapies can fall below the rates reported 10 years ago in the original pivotal studies. Indeed, as you can see in more recent studies, the intent to treat SBR rates fall below the rates reflected in labels established a decade ago, including rates as low as 74% among people who injected drugs with rates consistently in the low 90s.

Glide 13 summarizes the top-line results for C-Beyond. The trial met its primary and secondary endpoint with Benrules SBR demonstrating consistent SBR rates regardless of cirrhosis status and robust performance across genotypes. biological failure rates were low and comparable across treatment arms. Benzalurusvir was generally safe and well-tolerated with a safety profile comparable to soft-belly. On slide 14 is the patient populations and analysis for C-Forward, our second phase 3 trial, being conducted outside of North America to enable a broad pangenotypic label. It is fully enrolled and enriched for genotypes 1B, 3, 4, 5, and 6. using the same non-inferiority methodology and the same powering assumptions. Together, the two Phase III studies will form a comprehensive global data package for regulators worldwide. I will now hand the call over to Janet, our Chief Development Officer.

Janet Hammond

Thank you, Arantja. Good afternoon, everyone. Moving on to slide 16. M. rususvira is a next generation, pangenotypic, one-stady, six-dose regimen. C-phosphovir is the most potent nucleotide we are aware of, being approximately tenfold more active than C-phosphovir in vitro. And RuSYSVIR is a picomolar potency pan-genotypic NS5A inhibitor. Together, they have been administered to thousands of individuals with generally favorable of the intolerability. Compared to hepcluthor and Mavrit, remrosesvir is the only regimen positioned to offer the full combination of short eight-week duration for non-cirrhotic patients, protease inhibitor-free composition, low potential for drug-drug interactions, and no food effects. That combination is what defines a potential best-in-class profile.

On slide 17, the drug-drug interaction profile is a key differentiator for BEM-resilient. Roughly 80 to 90% of hepatitis C patients in the United States take concomitant medications and prescribers strongly prefer therapies that are simple to prescribe across the classes of oral contraceptives, protease inhibitors and integrase inhibitor HIV regimens, statins, immunosuppressants, digoxin, and proton pump inhibitors and other acid-reducing therapies, BEM-Rusazere is expected to be broadly compatible where competitors carry contraindications or require dose modifications. fewer drug interactions, strychnine fewer specialist referrals, fewer treatment delays, and more patients actually starting and completing therapy. Today's treatment challenge is less about efficacy and more about treatment duration, adherence, drug-drug interactions and access. Based on the potential profile of Benruzizir, we believe our regimen is well positioned to address these barriers and expand the number of patients successfully treated. I'll now turn the call over to John Vavrica, our Chief Commercial Officer.

John Vavricka

Thank you, Janet. Let's move on to slide 19. I want to address what we believe is a widely misunderstood dynamic in the HCD market. Wall Street often looks at revenue trends for approved HCD therapies and concludes that this is a declining market. However, the prevalence and treatment data tell a different story. Early diagnosed patients with HCD infections continue to outpace patients treated annually, and that gap is widening. In 2025, only around 50% of those new infected patients were treated. The result is a growing HCD-infected population moving towards 4 million people in the United States. which is an expanding addressable market.

The test and treat model of care is emerging as a reality and will serve as a critical lever to close the gap of untreated patients. It will enable seamless rapid diagnosis and treatment initiation at the same point of care visit, reduce barriers for prescribing, and drastically reduce patient attrition even before treatment begins. This model has broad bipartisan support and is gaining momentum as a pathway towards HCV eradication in the United States. I do believe our regimen's profile is optimal for this model of care. Let's move on to slide 20. Current HCD market dynamics create a clear opportunity for Benmore Xeor. Short duration regimens continue to gain share and prescribing is increasingly driven by polypharmacy and comorbidities.

New infections keep outpacing treatment and there is a decrease in commercial efforts by competitors. Each of these trends plays directly to the strengths of BMR-ZR. We believe a potential best-in-class profile can expand treatment eligibility and improve treatment completion for patients whose medications, comorbidities, and life circumstances have historically limited access and adherence. In addition, there is market growth potential with a simplified therapy and a focused commercialization. Moving on to slide 21, on-market research supports strong uptake of Ben-Marzir. Among high volume DAA prescribers, 76% said they would be extremely likely to prescribe Ben-Marzir. And the research predicts roughly half of both non-cirrhotic and compensated cirrhotic patients would receive Ben-Marzir relative relative to Occlusa and MaviRed.

On slide 22, we believe Benoit's ER is uniquely positioned to capture untreated patients and grow the market, not simply to compete for existing share. Currently, only about half of diagnosed patients in the U.S. are treated annually, leaving roughly 75,000 untreated new infections last year on top of the already large prevalent pool of patients. In 2025, U.S. net sales were $1.3 billion, representing 50% of the global net sales of $2.6 billion. With its differentiated profile, BAM-RZR is uniquely positioned to expand the market, potentially up to $2.5 billion annually in the United States. Slide 23. Taken together, we see peak annual U.S. net revenue potential in excess of 700 million. That's anchored on a widening gap between infections and cures, up to 4 million infected, and the increasing number of untreated people in the United States as a total addressable market. The pricing is expected to be in line with existing branded VA regimens.

In closing, on slide 24, we continue to advance our commercial readiness activities across all key areas. The HCV prescriber base is highly concentrated with approximately 7,800 physicians writing roughly 80% of all DAA prescriptions in the U.S., We can reach the vast majority of this market with a focused specialty sales force of approximately 75 to 100, including sales representatives, sales managers, and medical science liaisons. All components and processes for large scale manufacturing are in place. Commercial launch supply is already underway with low cost of goods relative to the expected net price. And our four week dosing blister card packaging supports patient convenience and adherence. We believe these factors position us for a short time to profitability following a launch. I'll now turn the call back to Janet. that to review the hepatitis E program.

Thank you, John.

Janet Hammond

And slide 26. In July, we initiated our first in human phase one clinical trial of AT587. The study is being conducted in healthy volunteers with the primary objectives of evaluating safety, tolerability, and pharmacokinetics. It is a randomized double-blind placebo control design with sequential dose escalation and an embedded food effect assessment. The study includes both single ascending and multiple ascending dose phases. providing flexibility to refine dose levels as data emerge, and with dose progression informed by real-time safety and PK review. We have recently completed the first cohort and are moving forward to the next cohort. Hepatitis E has no approved therapy, so this is a potential first in class opportunity that provides a meaningful pipeline program beyond hepatitis C. to turn the call over now to Andrea Corcoran as Chief Financial Officer to discuss the TAIRS financials.

Andrea Corcoran

Thanks, Janet. As Joneigh mentioned in her introductory remarks, earlier today we issued a press release containing our financial results for the second quarter of 2026. The Statement of Operations and Balance Sheet can be found on slides 28 and 29. We are pleased to report that our cash and investments balance was $219.5 million at June 30, 2026. The funds we expended in the second quarter were principally directed to the advancement of our HCV Phase III clinical trials, See Beyond and See Forward, and to a lesser extent to the completion of clinical trial startup activities for the first in human study of AT587, which Janet just described is our product candidate for the treatment of HEV. As we have noted recently, milestone events in each program have been realized with the announcement of positive top line results in CPONs, the completion of patient enrollment in C4WRDS, and the initiation of the first in human clinical study of AT527. In the first six months of 2026, our R&D expenses increased compared to the prior year. principally driven by higher external spend related to the HCV phase III program and incremental HEV preclinical and clinical trial startup activities. The incremental expenses were partially offset by lower internal expenses, primarily due to decreases in stock-based compensation and payroll-related costs.

With respect to G&A, there was a decrease in the first six months of 2026 compared to the prior year due principally to lower salaries and lower wages as well as lower stock-based compensation. During the second half of 2026, we intend to maintain our rigorous financial discipline while remaining laser focused on execution and value creating advancement of our HCV and HEV product candidates. As we complete C-Forward, prepare to submit our regulatory filings and engage in pre-launch activities to support substantial majority of our spending will remain focused on the advancement of our Hepatitis C program. With the resources in hand at the end of June, we expect to realize these value-creating milestones for both programs and we project our cash runway to extend through 2027.

Jean-Pierre Sommadossi

I'll now hand the call back to Jean-Pierre for closing remarks. Thank you, Andrea. In closing, on slide 30, I would like our milestones are clear and all near term. We completed patient enrollment for C4 in June and top-line results are expected in early Q1 2027. Pending positive results from C4, our NDA submission is anticipated in the second quarter of 2027. In parallel,.

Operator

Ladies and gentlemen, please remain on the line. We are experiencing a technical difficulty. Once again, please remain on the line. a technical difficulty. © transcript Emily Beynon © BF-WATCH TV 2021 Thank you. JP, you may continue.

Jean-Pierre Sommadossi

I was disconnected. So in parallel, our hepatitis E program is progressing very well and advancing toward proof of concept in 2027. We believe that BAM uses potential best in class profile, including high efficacy, short treatment duration, and long-term care. a low risk of drug-drug interactions, and not for the fact position us to meaningfully contribute to the goal of HCV eradication in the US and globally. Based on our projection, we expect a short time to profitability after the anticipated mid-2028 launch. We look forward to keeping you updated on our progress. And with that, I will now turn the call back over to the operator.

Operator

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from Andy Shea with William Blair.

Please go ahead.

Unknown Speaker

Great. Thanks for taking our questions and congratulations on the big milestone for the company. So my first question has to do with... I think JP, you mentioned about the new mechanism of action. I'm curious, with the assembly disruption mechanism, how do you get that into the label that's number one number two It has to do with the test and treat model. I think Johnny mentioned about that. He also mentioned about the one month blister pack. Based on some of the conversations with KOL, they really like to see kind of test and treat model.

On top of that, you basically give all the drugs in one setting. And I'm just wondering what steps do you have to take to really reach that goal? Thank you so much.

Jean-Pierre Sommadossi

Okay. First, Andy, thanks for your scientific knowledge. And we have not released yet all the data. And we continue to build upon this new MOA. And we anticipate to share with the FDA early next year when we'll have the full dataset. So it's a little bit early for me to discuss about it, but obviously we will present at scientific meetings and share with the FDA with the impact that we believe that this supplemental important MOA for them and totally unique. John.

John Vavricka

John, you want to address the second question of Andy? Sure. Thanks, Andy. Yes, test and treat is what the KOLs are looking to, what they do believe will actually increase the number of patients that are treated. And you are correct that the way that they would like to practice it is the patient is diagnosed and then immediately treated. just like the other products that are out there. So we will have both bottles and for these blister packs. And similar to the other products, you would have to like the, you know, give two blister packs out if that's what the patient required or two bottles out. Very similar to what you have going on today. The reason for the blister packs was it was just identified as a more convenient way for the ACV patients, and we're trying to do everything we can to make them take their medication and be more compliant.

It's just a matter of the quantity that you'll give them at that time. Does that answer your question, Andy?.

Unknown Speaker

Yes, so I guess the question also has to do with kind of refilling requirements. So after the first month, based on payers or other stakeholders. Basically, how do you eliminate that step to get a refill?.

John Vavricka

So, I don't have that answer for you today. What I can tell you is that in talking with physicians who do practice test and treat within their respective states, the payers for those respective states have allowed them to give the appropriate amount without a refill to those patients. And that would be specific to the programs. So you are correct, where it is existing, they do give them to everyone. Would every physician be able to provide test and treat today? That's part of the challenges and the mechanisms that will have to be worked out. But I can tell you in talking to these physicians who have implemented the test and treat and have provided the treatment at that visit, they do see great promise and great success. The one thing that they were very excited about for our profile is that it really would be the best profile to use in the test and treat because of the potential lack of drug-drug interactions and not have to worry about what a patient is either taking now or will be taking, and it will offer the shortest course of therapy.

Operator

Great. Thanks so much. Our next question comes from Jonathan Miller with Evercore ISI. Please go ahead.

Unknown Speaker

Hello, this is Yuan Yuan for John. Thanks for taking my question and congrats again on the FICS-3 data. So I'd like to touch on the AASLD simplified treatment algorithm. So can you walk us through the process and timeline to get the treatment included in the guideline and what evidence do you think will be most important for the panel to see from the C-Beyond and C-Forward results to include them in the treatment algorithm. Thank you.

Unknown Speaker

Lorenza, you want to address that? Sure. I think what they are looking for is best-in-class profile. So this is what we are offering here. It's the eight-week for the majority of the patients. And once they see these results, and we obviously get a label and an approval, I think I think that it will not be difficult with this profile to get it into treatment algorithms. and, you know, have it prescribed by physicians. We're hearing really excellent feedback from our PIs.

Jean-Pierre Sommadossi

Okay, thank you. I just want to add one point, is that for both the North American trial and the C4, so in 17 countries, it's absolutely remarkable that we were able to fully enroll. about 900 patients in less than eight months. So with 120 clinical sites with a high demand. And we could see at the end that the demand was going exponentially and we had actually to unfortunately stop because we could not go beyond much more in terms of the number of targeted patients. But there was really a high demand for for this clinical trial in both North America, the U.S., as well as in these 17 countries.

Operator

Next question please. Thank you. Our next question comes from Maxwell Score with Morgan Stanley. Please go ahead.

질의응답

Maxwell Skor

Great. Thank you very much for taking my question and congrats on the update. Regarding the non-inferiority, which also cleared on the per protocol secondary in CBEYOND, which is the C-forwards primary endpoint for the EMA, how much does that lift your confidence going into the early 1Q27 and readout. Also, how comparable do you expect the baseline characteristics to be across the two studies given C-Forward's different geographies and genotype mix? And finally, if I can ask just one more, maybe elaborate a bit more on the pricing reforms, the Medicare Part D and 340B, and how they're related.

Jean-Pierre Sommadossi

reshaping the competitive landscape? Thank you. Great question. Arantza, you want to tackle? We are going to basically report that at scientific meeting, but we do not worry. always worry, but we do not worry on the protocol. As you have seen, it's quite a bit of discontinuation, but we have sufficient power. So why don't you chime in as well and address the difference of patients, which actually, it is substantial. Arvind, can you go ahead? Yes, I think,.

Unknown Speaker

Max, I mean, it's a great question. So for the C4 word, We are more likely to see genotypes, obviously, that are not in the United States. So the United States predominantly is 1A. Ex-U.S., we're going to be seeing more of the 1Bs. And then some of the rare genotypes that we made an extraordinary effort to get, genotypes which are not common in the United States. And so it will differ in terms of genotypes, but I want to remind you that a lot of these genotypes we already treated in Phase II where we had genotype III in particular excellent results. In terms of the population, we think we'll see probably less transmission through the IV drug use, you know, that kind of population that we also saw in the Phase II, because globally there is still quite a lot of transmission through things like dental procedures, transplants, even blood transfusions.

And the population ex-US in general tends to report less frequently adverse events. They tend to be less lost to follow up. They tend to be a little more compliant with the protocol. So if anything, we think we're going to be seeing a more adherent population. and maybe even a little bit closer to what we saw in the Phase 2, where we had already excellent results. I think that was your main question for me. There was another one, though. Yes. I'm sorry, but do I think for John? Yes.

John Vavricka

Sure. So, Max, I think your question was on pricing reform and the various, you know, generous and other legislative 340Bs reshaping the landscape. And you are correct. And it depends on, you know, what segment that you're more heavily weighted in. And currently, the two products, whether it's Maverette or Abclusa, have different percentages of their business from Medicaid or Medicare. And those changes have already started to take to effect. So, for instance, having a higher percentage of Medicare patients, the Inflation Reduction Act has had an effect on that. In the past, manufacturers weren't responsible for a percentage of the total prescription cost there, and that is happening. now. As far as the other things you mentioned like generous and so forth, which is, you know, MSN type pricing and its effect on Medicaid.

It could affect the Medicaid discounts that are currently being offered. But there's something interesting, Max, and that is when you start looking at the pricing differential between the US, for instance, and a lot of these generous or mainly EU countries or Western countries, the pricing isn't as dramatically different from the U.S. as other types of pharmaceutical products. And we were kind of shocked at that. So the impact will not be as dramatic as some people think. The other thing to bear in mind is that some manufacturers are already cutting direct deals with individual state Medicaid agencies beyond the statutory discounts to be provided. And so from that standpoint, the difference between the extra rebates that they're already providing and what the generous or the extra rebates for MFN might be, which could theoretically be smaller. But that's what we know now.

The other last thing you mentioned was 340B. I think the proposed legislative or the administrative changes that are happening for 340B, I think will be favorable to the manufacturers in the sense that, you know, if the current thinking goes through, instead of providing an outright discounted price, that it would be handled through a rebate mechanism, thus allowing the manufacturers to make sure that they're not getting double counted on both Medicaid and 340B. But so we'll have to stay tuned to see what happens with that.

Jean-Pierre Sommadossi

Thank you very much. Max, I want to go back just to make sure that there is no misunderstanding here. On the C4, the purple core is the primary endpoint for the EMA. But for the FDA, the MITT is the primary endpoint. primary endpoint. Okay, so please be aware that the MITT has the CBN for C4, the primary endpoint for the FDA will be the MITT. So essentially we will have two primary endpoints in the C4s. I hope that just to make sure that- Very helpful. Thank you for clarifying. I appreciate it.

Thanks. Okay. Very good. Thank you, Max. And any other questions? So thank you all for joining our second quarter conference call, and thank you for your continued support.

Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

This live transcript is auto-generated without human intervention or review.

[Call has ended.]