Eiger BioPharmaceuticals Inc (EIGR) 2022 Q3 法說會逐字稿

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  • Operator

    Operator

  • Welcome to the Eiger BioPharmaceuticals Third Quarter 2022 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.

    歡迎參加艾格生物製藥公司2022年第三季財務業績及業務更新電話會議。目前所有與會者均處於僅收聽模式。稍後我們將進行問答環節,屆時將提供相關說明。

  • (Operator Instructions)

    (操作說明)

  • As a reminder, this call will be recorded.

    再次提醒,本次通話將會被錄音。

  • I would now like to turn the call over to Sarah Mathieson, Senior Vice President, Corporate Affairs at Eiger. You may begin.

    現在我將把電話交給艾格公司企業事務資深副總裁莎拉‧馬西森。您可以開始了。

  • Sarah Mathieson - Senior Vice President, Corporate Affairs

    Sarah Mathieson - Senior Vice President, Corporate Affairs

  • Thank you. Good afternoon, everyone and thank you for joining us today. Welcome to our quarterly financial results and business update call. We issued a press release earlier this afternoon with our Q3 financial results, which is also available on our Web site at eigerbio.com. For today's call, we will have prepared remarks from the management team followed by Q&A. We will use slides for the webcast and a replay will be available on the Investors section of our Web site.

    謝謝。大家下午好,感謝各位今天參加我們的電話會議。歡迎參加我們的季度財務業績及業務更新電話會議。今天下午早些時候,我們發布了第三季財務業績的新聞稿,您也可以造訪我們的網站eigerbio.com查看。今天的電話會議將由管理團隊發言,隨後是問答環節。我們將使用幻燈片進行網路直播,會議回放將在我們網站的投資者關係頁面提供。

  • Joining me on the call with prepared remarks are David Cory, President and CEO; Sri Ryali, Chief Financial Officer; Eldon Mayer, Chief Commercial Officer; and Dr. Ingrid Choong, Senior Vice President, Clinical Development. We also have subject matter experts on our team Dr. Colin Hislop, Senior Vice President, Clinical & Development Operations and Dr. Colleen Craig, Vice President of Metabolic Diseases available for Q&A.

    與我一同參加此電話會議並準備發言的有:總裁兼執行長David Cory;財務長Sri Ryali;商務長Eldon Mayer;以及臨床開發資深副總裁Ingrid Choong博士。此外,我們團隊的臨床與開發營運資深副總裁Colin Hislop博士和代謝疾病副總裁Colleen Craig博士也將作為專家出席,解答大家的疑問。

  • Before we begin, I would like to remind investors that this call will include forward-looking statements, including expectations concerning financial performance, commercial products and

    在正式開始之前,我想提醒各位投資者,本次電話會議將包含前瞻性陳述,包括對財務表現、商業產品等方面的預期。

  • potential future products in different therapeutic areas and stages of development. The forward-looking statements rely on certain assumptions and involve risks and uncertainties beyond Eiger's control, which could cause our actual results to differ materially. A description of these risks and uncertainties is contained in Eiger's filings with the SEC, including our latest 10-K and 10-Q reports available on the Eiger Web site in the Investors Section. All forward-looking statements are based on information currently available to Eiger and we assume no obligation to update these statements.

    未來可能推出的產品涵蓋不同的治療領域和研發階段。這些前瞻性陳述是基於某些假設,並涉及Eiger無法控制的風險和不確定性,可能導致我們的實際結果與預期有重大差異。有關這些風險和不確定性的描述,請參閱Eiger向美國證券交易委員會(SEC)提交的文件,包括我們最新的10-K和10-Q報告,這些報告可在Eiger網站「投資者關係」欄位中查閱。所有前瞻性陳述均基於Eiger目前可獲得的信息,我們不承擔更新這些陳述的義務。

  • I will now turn the call over to David.

    現在我將把通話轉給大衛。

  • David Cory - President, CEO

    David Cory - President, CEO

  • Thanks Sarah. At Eiger, we are committed to fulfilling the promise of high potential drugs for patients with serious diseases. To that end, we built a pipeline of multiple late stage breakthrough therapy designated programs, including our hepatitis delta virus platform Lonafarnib ritonavir, and Peginterferon lambda, two first-in-class therapies that are both in Phase 3. We're just weeks away from unblinding and reporting topline data from the Phase 3 D-LIVR study of two different Lonafarnib based regimens for the treatment of HDV.

    謝謝莎拉。在艾格製藥,我們致力於為患有重症的患者提供具有巨大潛力的藥物。為此,我們建立了一條包含多個後期突破性療法項目的研發管線,其中包括我們的丁型肝炎病毒平台洛那法尼(利托那韋)和聚乙二醇幹擾素λ,這兩種首創療法目前均處於III期臨床試驗階段。我們即將揭盲並發表基於洛那法尼的兩種不同丁型肝炎病毒治療方案的III期臨床試驗D-LIVR研究的主要數據。

  • With over 400 patients enrolled across 100 sites in over 20 countries, D-LIVR is the largest HDV study ever conducted. We look forward to recording data from this landmark study next month, an important milestone both for Eiger and for patients suffering from HDV. We're also making good progress advancing our second HDV therapy in development, Peginterferon lambda in the Phase 3 LIMT-2 study. We are activating 50 clinical trial sites and enrolling patients in 12 countries. Hepatitis delta is the most severe form of viral hepatitis, impacting more than 12 million people around the globe.

    D-LIVR 研究在 20 多個國家的 100 個研究中心招募了 400 多名患者,是迄今為止規模最大的丁型肝炎病毒 (HDV) 研究。我們期待下個月公佈這項里程碑式研究的數據,這對 Eiger 公司和 HDV 患者來說都是一個重要的里程碑。同時,我們正在推進第二項 HDV 療法——聚乙二醇幹擾素 λ 的 III 期 LIMT-2 研究,並取得了良好進展。我們正在 12 個國家啟動 50 個臨床試驗中心,招募病患。丁型肝炎是病毒性肝炎中最嚴重的類型,影響全球超過 1,200 萬人。

  • There are currently no FDA approved HDV therapies, and effective treatment options are desperately needed for these patients. We believe that based on their mechanisms of action and convenient administration, Lonafarnib and Peginterferon lambda are highly differentiated from other therapies in development. Ingrid will provide additional details on our plans for D-LIVR topline data and Eldon will comment on the HDV commercial opportunity and our commercialization plans in just a few minutes.

    目前尚無FDA核准的HDV療法,這些患者迫切需要有效的治療方案。我們認為,基於其作用機制和便捷的給藥方式,Lonafarnib和聚乙二醇幹擾素λ與其他在研療法相比具有顯著優勢。 Ingrid將在幾分鐘後詳細介紹我們關於D-LIVR初步數據的計劃,Eldon將就HDV的商業化機會和我們的商業化計劃發表看法。

  • Turning to our rare metabolic disease programs. We believe of Avexitide, our first-in-class GLP-1 receptor antagonist, has the potential to confer meaningful therapeutic benefit across a broad spectrum of hyperinsulinemic hypoglycemic conditions.

    接下來談談我們的罕見代謝疾病計畫。我們相信,我們首創的GLP-1受體拮抗劑Avexitide,有望在多種高胰島素血症性低血糖症中發揮顯著的治療作用。

  • For our lead indication, we have initiated the Phase 3 AVANT program in congenital hyperinsulinism, a rare life threatening disorder affecting neonates and children. With no approved treatments for congenital hyperinsulinism, new effective therapies are urgently needed. Avexitide has been granted FDA breakthrough therapy designation and rare pediatric disease designation, potentially making it eligible for a priority review voucher upon approval for congenital hyperinsulinism.

    我們已啟動針對先天性高胰島素血症的III期AVANT項目,這是我們的主要適應症。先天性高胰島素血症是一種罕見的危及生命的疾病,主要影響新生兒和兒童。由於目前尚無核准的先天性高胰島素血症治療方法,因此迫切需要新的有效療法。 Avexitide已獲得FDA突破性療法認定和罕見兒科疾病認定,一旦核准用於治療先天性高胰島素血症,可望獲得優先審查券。

  • We have agreement with FDA on the study design and endpoints, and expect to enroll over 40 neonates and children. We've been pleased by the enthusiasm and support from across both the clinical and patient advocacy communities for the AVANT program, and look forward to sharing more details as we begin activating sites and screening patients.

    我們已與FDA就研究設計和終點達成一致,預計招募40多名新生兒和兒童。我們很高興看到臨床界和患者權益倡導團體對AVANT計畫給予了極大的熱情和支持,並期待在啟動研究中心和篩選患者後分享更多細節。

  • Regarding Peginterferon lambda for COVID-19, we're disappointed that the FDA will not consider an EUA application of Peginterferon lambda for COVID-19 based on results generated from the investigator sponsored Phase 3 TOGETHER study. However, we continue to have strong conviction in the data and in the potential of Peginterferon lambda to confer a meaningful benefit for patients with COVID-19 and other respiratory viral infections.

    關於聚乙二醇幹擾素λ治療新冠肺炎,我們很失望FDA不會根據研究者發起的3期TOGETHER研究的結果考慮批准聚乙二醇幹擾素λ治療新冠肺炎的緊急使用授權申請。然而,我們仍然堅信這些數據以及聚乙二醇幹擾素λ能為新冠肺炎和其他呼吸道病毒感染患者帶來顯著療效。

  • We�re actively evaluating next steps for this program, both in the US and ex-US, as well as strategic options for continued development of Peginterferon lambda for COVID-19 and other respiratory viral infections. We plan to update as material progress warrants. And finally tuning to our commercial product. This year we've successfully expanded the global commercial reach of Zokinvy with marketing authorizations in the EU and UK, as well as a partnership with AnGes, a commercial stage biopharmaceutical company based in Japan. The approval of Zokinvy in the US and now in Europe demonstrates Eiger's ability to navigate complex global regulatory requirements and successfully commercialize medicines for patients in need. We're executing across our strategic priorities and continuing the momentum we've seen throughout 2022 to finish this year strong. We remain focused on our operational plan to drive growth by advancing our pipeline, leveraging our commercial capabilities to expand our reach, and strengthening the foundation of our business to prepare for growth.

    我們正在積極評估該計畫在美國及美國以外地區的後續步驟,以及繼續開發聚乙二醇幹擾素λ治療COVID-19和其他呼吸道病毒感染的策略選擇。我們將根據實質進展及時更新資訊。最後,我們專注於我們的商業化產品。今年,我們成功拓展了Zokinvy的全球商業版圖,獲得了歐盟和英國的上市許可,並與總部位於日本的商業化階段生物製藥公司AnGes建立了合作關係。 Zokinvy在美國和歐洲的獲批,充分展現了Eiger應對複雜全球監管要求並成功將藥物商業化,造福患者的實力。我們正在推動各項戰略重點,並延續2022年的發展勢頭,力爭在今年取得圓滿成功。我們將繼續專注於營運計劃,透過推進產品線、利用商業能力擴大市場覆蓋範圍以及夯實業務基礎,為未來的成長做好準備,從而推動業務成長。

  • I'll now hand the call over to Ingrid.

    現在我將把電話交給英格麗德。

  • Ingrid Choong - Senior Vice President, Clinical Development

    Ingrid Choong - Senior Vice President, Clinical Development

  • Thanks, David. I'll begin by highlighting our continued progress across our hepatitis delta virus platform. As David noted, we are excited that we are just weeks away from unblinding and reporting topline data from the landmark Phase 3 D-LIVR study of two Lonafarnib based regimens.

    謝謝,David。首先,我想重點介紹一下我們在丁型肝炎病毒治療平台上的持續進展。正如David所提到的,我們非常高興地宣布,距離揭盲並公佈基於洛那法尼(Lonafarnib)的兩種治療方案的里程碑式3期D-LIVR研究的主要數據僅剩幾週時間。

  • Our clinical team is in the process of cleaning the database before it can be locked and analyzed to report top line results. This milestone is years in the making for Eiger and HDV patients. As the largest study conducted in hepatitis delta virus, D-LIVR will generate a comprehensive source of patient data from a well controlled global clinical trial to better understand and characterize this devastating progressive disease and if positive support global regulatory filings. The design of the Phase 3 D-LIVR study was informed by our Phase 2 Lonafarnib HDV platform.

    我們的臨床團隊正在清理資料庫,之後才能鎖定資料庫並進行分析,以公佈初步結果。對於艾格氏症和丁型肝炎病毒(HDV)患者而言,這項里程碑意義重大,歷經數年方才得以實現。作為迄今為止最大的丁型肝炎病毒研究,D-LIVR 將透過一項控制良好的全球臨床試驗,產生全面的患者數據,從而更好地了解和描述這種破壞性極強的進行性疾病,如果結果積極,還將為全球監管申報提供支持。 D-LIVR III 期研究的設計借鑒了我們 II 期 Lonafarnib HDV 平台的研究成果。

  • To recap, this broad Phase 2 program spanned five studies and explored over 50 different Lonafarnib based regimens in 129 HDV infected patients. And the regimens that were subsequently advanced into Phase 3, the composite endpoint defined as a two log decline in HDV RNA and normalization of ALT was achieved in 29% of patients receiving the all oral regimen and 63% of patients receiving the combination with Peginterferon Alpha after 24 weeks of treatment.

    綜上所述,這項廣泛的二期臨床試驗項目涵蓋五項研究,在129名HDV感染患者中探索了超過50種不同的基於洛那法尼的治療方案。隨後進入第三期臨床試驗的方案中,在接受全口服方案治療的患者中,29%達到了HDV RNA下降兩個對數級且ALT恢復正常的複合終點;而在接受洛那法尼聯合聚乙二醇幹擾素α治療的患者中,24周治療後達到該終點的患者比例為63%。

  • The Phase 3 D-LIVR study provides multiple paths to registration of two Lonafarnib based regimens, the primary endpoint is a composite of a two log decline in HDV RNA and normal rotation of ALT after 48 weeks of treatment. If either of the Lonafarnib base regimens, the all oral or the combination with Peginterferon Alpha meet the primary endpoint versus placebo, we have a path for an NDA submission. Importantly, we do not need to see response rates higher than any other investigational therapies for a successful outcome.

    D-LIVR III期研究為兩種基於洛那法尼的治療方案提供了多種註冊途徑。研究的主要終點是治療48週後HDV RNA下降兩個對數級且ALT恢復正常水平的複合終點。如果兩種基於洛那法尼的治療方案(全口服或與聚乙二醇幹擾素α聯合)中任何一種達到主要終點(與安慰劑相比),我們即可提交新藥申請。重要的是,我們無需看到高於其他任何在研療法的應答率即可獲得成功。

  • We believe that in a chronic disease like HDV where patients maybe on treatment for many years, there will be a high patient demand for an all oral treatment option or an oral regimen combined with a weekly interferon that delivers a robust response. A key secondary endpoint of D-LIVR is histology, assessed using baseline and week 48 and the treatment paired liver biopsies. In a disease as aggressive as hepatitis delta virus, demonstrating stabilization of fibrosis in a treatment arm compared to placebo would be clinically meaningful for patients as this could potentially obviate the need for liver transplants. We expect to report both the primary endpoint and key secondary endpoints when we report topline results in December, and we�ll host an investor call to discuss the data.

    我們相信,對於像丁型肝炎病毒(HDV)這樣的慢性疾病,患者可能需要接受多年的治療,因此,患者對全口服治療方案或口服聯合每週一次幹擾素治療方案(能夠提供強效療效)的需求將非常高。 D-LIVR 的一個關鍵次要終點是組織學,評估方法為基線、第 48 週以及治療後配對的肝臟活檢。對於像丁型肝炎病毒這樣侵襲性極強的疾病,如果治療組的纖維化程度能夠穩定,與安慰劑組相比,這將對患者俱有重要的臨床意義,因為這可能避免患者接受肝臟移植。我們預計將在 12 月公佈初步結果時同時報告主要終點和關鍵次要終點,屆時我們將召開投資者電話會議討論相關數據。

  • Turning to our second HDV program, Peginterferon lambda. The Phase 3 LIMT-2 study continues to activate sites and enroll patients. LIMT-2 is a straightforward study of 150 patients largely enrolling from the best performing sites from the D-LIVR study. LIMT-2 is a randomized two arm study; arm one is 48 weeks of Peginterferon lambda once weekly, followed by 24 weeks off treatment; arm two is 12 weeks of no treatment.

    接下來介紹我們的第二個HDV計畫—聚乙二醇幹擾素λ。 III期LIMT-2研究正在持續啟動各研究中心並招募患者。 LIMT-2是一項直接的研究,計劃招募150名患者,主要來自D-LIVR研究中表現最佳的研究中心。 LIMT-2是一項隨機雙臂研究;第一組接受為期48週的每週一次聚乙二醇幹擾素λ治療,隨後停藥24週;第二組不接受治療12週。

  • The primary endpoint is the proportion of patients with HDV RNA below the limit of quantitation at 24 weeks post treatment in arm one compared to 12 weeks of no treatment in arm two. All patients in arm two will be offered the option to move to active treatment after 12 weeks, making this an attractive study where all patients can be treated with Peginterferon lambda. This Phase 3 primary endpoint was previously demonstrated in Phase 2 where 36% of patients achieved HDV RNA below the limit of quantitation at 24 weeks post treatment, a durable virologic response or DVR. This is similar to the sustained virologic response or SVR endpoint previously used for HCV therapies. The DVR endpoint is meaningful for regulatory agencies and physicians as it demonstrates durability and response to a finite therapy and the potential for a cure for hepatitis delta virus.

    主要終點為第一組患者在治療後24週時HDV RNA低於定量限的患者比例,並與第二組患者在未接受治療12週時的比例進行比較。第二組所有患者在12週後均可選擇接受活性治療,使得本研究極具吸引力,因為所有患者均可接受聚乙二醇幹擾素λ治療。該3期主要終點先前已在2期研究中得到證實,當時36%的患者在治療後24週時HDV RNA低於定量限,即達到持久病毒學應答(DVR)。這與先前用於HCV治療的持續病毒學反應(SVR)終點相似。 DVR終點對監管機構和醫生具有重要意義,因為它證明了有限療程的持久性和回應性,以及治癒丁型肝炎病毒感染的潛力。

  • Our strategic approach in HDV is to seek regulatory approvals of two Lonafarnib based regimens from the results of the D-LIVR study. We will follow with data from LIMT-2, which could lead to approval of Peginterferon lambda for HDV. We believe this approach provides the most expeditious route to approval for both Lonafarnib and Peginterferon lambda. In parallel, we will generate data through the NIH Phase 2 LIFT study, which we believe will support the future use of our proprietary combination of Lonafarnib ritonavir and Peginterferon lambda for hepatitis delta infection. We are excited about the continued advancements in the HDV space.

    我們在HDV領域的策略方針是基於D-LIVR研究的結果,尋求兩種基於洛那法尼(Lonafarnib)的治療方案的監管批准。隨後,我們將公佈LIMT-2研究的數據,該研究可望促成聚乙二醇幹擾素λ(Peginterferon lambda)獲準用於治療HDV。我們相信,這項策略能夠最快地為洛那法尼和聚乙二醇幹擾素λ的核准鋪路。同時,我們將透過NIH II期LIFT研究收集數據,我們相信該研究將支持我們專有的洛那法尼利托那韋(Lonafarnib ritonavir)聯合聚乙二醇幹擾素λ用於治療丁型肝炎病毒感染的未來應用。我們對HDV領域的持續進展感到振奮。

  • Last month, Eiger participated in the first international Delta Cure Conference, the only medical meeting focused solely on hepatitis delta, and we look forward to attending AASOD, the liver meeting, starting tomorrow in Washington DC. With topline data from D-LIVR right around the corner and continued progress enrolling the LIMT-2 study, Eiger�s contributing to the strong momentum in this space. We believe our platform of first-in-class differentiated therapies positions as well to become a leader in HDV.

    上個月,Eiger參加了首屆國際Delta Cure大會,這是唯一一個專注於丁型肝炎的醫學會議。我們期待參加明天在華盛頓特區開幕的肝病學年會(AASOD)。隨著D-LIVR研究的主要數據即將公佈,以及LIMT-2研究招募工作的持續進展,Eiger正為該領域的強勁發展勢頭貢獻力量。我們相信,我們首創的差異化療法平台也將使我們成為丁型肝炎病毒(HDV)領域的領導者。

  • I'll now turn the call over to Eldon.

    現在我將把電話交給艾爾頓。

  • Eldon Mayer - Chief Commercial Officer

    Eldon Mayer - Chief Commercial Officer

  • Thanks Ingrid.

    謝謝英格麗德。

  • I'll spend the next few minutes providing an overview of our commercial planning for the anticipated launch of Lonafarnib based regimens for the treatment of HDV. As Ingrid noted, D-LIVR provides multiple potential pathways to registration of Lonafarnib based regimens. We believe that either Lonafarnib based regimens, the all oral Lonafarnib ritonavir or the combination with Peginterferon Alpha, has the potential to confer benefits to HDV patients and represents a significant commercial opportunity. These are exciting times for the commercial team at Eiger. Collectively, this team has extensive experience with product launches, specifically in the orphan disease space.

    接下來幾分鐘,我將概述我們針對即將上市的基於洛那法尼(Lonafarnib)的HDV治療方案的商業計劃。正如Ingrid所指出的,D-LIVR為基於洛那法尼的治療方案的註冊提供了多種潛在途徑。我們相信,無論是基於洛那法尼的治療方案(全口服洛那法尼利托那韋)還是與聚乙二醇幹擾素α的聯合用藥,都有可能使HDV患者獲益,並代表著巨大的商業機會。對於Eiger的商業團隊來說,這是一個令人興奮的時刻。該團隊在產品上市方面擁有豐富的經驗,尤其是在罕見疾病領域。

  • Over the past 25 years, we've launched 10 FDA approved therapeutics for multiple orphan diseases across different therapeutic areas. Eiger has been developing therapies for HDV for over a decade. During that time, we've built strong relationships with HDV investigators and key opinion leaders, conducted market research and developed our launch plans, which we continue to refine. With Phase 3 D-LIVR data now imminent, we are closer to operationalizing these plans. As David noted, HDV is a significant unmet medical need, impacting more than 12 million people around the globe. In the US and Europe, HDV is a large orphan disease with an estimated prevalent patient population of 300,000. The potential of the HDV commercial opportunity has been validated by the recent entry of multiple other companies with early stage development programs into the space where there are currently no FDA approved therapies.

    過去25年,我們已針對多種罕見疾病,在不同的治療領域推出了10種獲得FDA核准的療法。 Eiger公司在HDV療法研發方面已深耕十餘年。在此期間,我們與HDV研究人員和關鍵意見領袖建立了牢固的合作關係,開展了市場調查,並製定了上市計劃,並且仍在不斷改進。隨著D-LIVR III期臨床試驗數據的即將公佈,我們距離這些計畫的實施又更近了一步。正如David所指出的,HDV是一種尚未滿足的重大醫療需求,影響著全球超過1,200萬人。在美國和歐洲,HDV是一種大型罕見疾病,估計患病人數達30萬人。近期,多家其他公司帶著早期研發項目進入HDV市場,進一步印證了該領域的巨大商業潛力,因為目前尚無FDA批准的療法。

  • Both our HCV programs Lonafarnib ritonavir and Peginterferon lambda are at late stage and we believe highly differentiated from other therapies in clinical development. Lonafarnib ritonavir is the only oral therapy in clinical development for HDV, and we expect that patient preference for a convenient all oral HDV therapy or a combination with interferon that delivers a robust response will be high. By the time, we launch Lonafarnib, we expect increased awareness and diagnosis rates of hepatitis delta virus made possible by greater utilization of commercial HDV PCR tests and update to EASL and AASLD testing guidelines. In the future, we believe that as a first in class type three interferon, Peginterferon lambda�s tolerability profile has the potential to make it the interferon of choice for physicians and patients, leading to better compliance and improved outcomes.

    我們的兩個丙型肝炎(HCV)計畫-洛那法尼(Lonafarnib ritonavir)和聚乙二醇幹擾素λ(Peginterferon lambda)-都已進入後期研發階段,我們相信它們與其他處於臨床開發階段的療法有顯著差異。洛那法尼是目前唯一處於臨床開發階段的口服丁型肝炎(HDV)治療藥物,我們預期患者對便捷的全口服HDV療法或能提供強效療效的干擾素聯合療法的偏好度會很高。到洛那法尼上市之時,我們預計隨著商業化HDV PCR檢測的廣泛應用以及EASL和AASLD檢測指南的更新,人們對丁型肝炎病毒的認知度和診斷率將會提高。展望未來,我們相信作為首個同類III型乾擾素,聚乙二醇幹擾素λ的耐受性有望使其成為醫生和患者的首選幹擾素,從而提高患者依從性並改善治療效果。

  • We are planning for a focused and cost efficient HDV commercial launch. The same physicians who treat patients with HDV treat patients with delta virus and delta is only found as a co-infection with HBV. As you can see from this map in the US, HBV prescribers are heavily concentrated in major metropolitan areas. 70% of HBV scripts are written by 10% of HDV prescribers, a dynamic that allows for a lean targeted field force.

    我們正計劃以目標明確、成本效益高的方式推出HDV疫苗。治療HDV患者的醫師也治療丁型肝炎病毒感染者,而丁型肝炎病毒僅與HBV合併感染。正如您從這張美國地圖上看到的,HBV處方醫生高度集中在主要都會區。 70%的HBV處方由10%的HDV處方醫生開具,這種格局使得我們能夠組建一支精簡高效的銷售團隊。

  • Outside the US, we believe that D-LIVR data could provide opportunities for strategic collaborations. While we're planning for a successful US launch, we are preserving our options for partnerships in both the US and in Europe. In China, where there are an estimated to be more than 1 million hepatitis delta patients, we will pursue a partnering strategy to provide access to patients in this important market, while maximizing potential for shareholder value. Following D-LIVR results, we plan to share additional details on our plans for commercialization of Lonafarnib based regimens for HDV.

    在美國以外,我們相信D-LIVR數據能夠為策略合作提供機會。雖然我們正在為在美國成功上市做準備,但我們也保留了在美國和歐洲合作的可能性。在中國,據估計有超過100萬名丁型肝炎患者,我們將採取合作策略,為這一重要市場的患者提供治療,同時最大限度地提高股東價值。 D-LIVR試驗結果公佈後,我們將分享更多關於基於洛那法尼治療丁型肝炎的方案商業化計劃的細節。

  • Finally, a quick update on Zokinvy. We reported $4 million in net sales during the third quarter in the US. As we previously stated, 80% of identified US patients with Progeria received Zokinvy with 100% payer reimbursement coverage. In July, we announced EMA approval of Zokinvy. Demonstrated success in our reimbursement strategy, we secured reimbursement in two of the largest European markets, in France, under our reimbursed early access program and most importantly, in Germany. We expect our first shipment to Germany by the end of this year. We have appropriate infrastructure in place for a successful commercialization across the EU, including distribution and patient support services.

    最後,我們簡單更新一下Zokinvy的最新進展。第三季度,我們在美國實現了400萬美元的淨銷售額。正如我們之前所述,80%的美國早衰症患者接受了Zokinvy治療,並獲得了100%的醫療保險報銷。 7月,我們宣布Zokinvy獲得EMA批准。我們的報銷策略取得了顯著成功,我們在歐洲兩大市場——法國(透過我們的早期准入計畫)和德國——都獲得了報銷。我們預計今年年底前向德國發出首批貨物。我們已為在歐盟範圍內的成功商業化做好了充分的準備,包括分銷和病患支援服務。

  • We're engaged with healthcare providers who are managing patients with Progeria, as well as reimbursement authorities, ministries of health and local payers to obtain reimbursement in each country. In summary, we're pleased with our progress to date, excited about the commercial potential of our programs and confident in our ability to execute an efficient launch of lonafarnib based regimens for HDV. As I've noted before, the infrastructure we've established in the US and now in Europe for the launch of Zokinvy for Progeria has been designed to scale and grow to support future launches and larger indications, including HDV as we advance our mission to help patients with serious diseases.

    我們正與治療早衰症患者的醫療服務提供者、健保機構、衛生部以及當地支付方積極溝通,以確保在各國獲得醫保報銷。總而言之,我們對迄今為止的進展感到滿意,對我們計畫的商業潛力充滿信心,並有信心高效地推出基於lonafarnib的HDV治療方案。正如我之前提到的,我們在美國以及現在的歐洲為Zokinvy治療早衰症的上市所建立的基礎設施,旨在實現規模化發展,以支持未來的產品上市和更廣泛的適應症,包括HDV,從而推進我們幫助重症患者的使命。

  • I will now hand the call over to Sri for financial update.

    現在我將把電話交給 Sri,讓他報告財務狀況。

  • Sri Ryali - Chief Financial Officer

    Sri Ryali - Chief Financial Officer

  • Thanks, Eldon. The press release we issued this afternoon include the financial update, and I'll call out a few highlights here. As Eldon noted, total revenue this quarter was $4 million, which consisted entirely of US Zokinvy net sales. This compares to $3 million reported for third quarter 2021 and $3.3 million for second quarter 2022. Higher net sales in Q3 were largely driven by additional units shipped during the quarter. Turning to our third quarter 2022 GAAP operating expenses. Cost of sales was $1.2 million, which included a onetime write off of a nonconforming batch of inventory in the quarter. R&D expenses were $22.2 million and SG&A expenses were $7 million for the quarter.

    謝謝Eldon。我們今天下午發布的新聞稿包含了財務更新,我在這裡重點介紹一下。正如Eldon所指出的,本季總收入為400萬美元,全部來自Zokinvy在美國的淨銷售額。相較之下,2021年第三季為300萬美元,2022年第二季為330萬美元。第三季淨銷售額的成長主要得益於本季出貨量的增加。接下來是2022年第三季的GAAP營運費用。銷售成本為120萬美元,其中包括本季一次性沖銷一批不合格庫存。研發費用為2,220萬美元,銷售、管理及行政費用為700萬美元。

  • We reported a third quarter net loss of $27.1 million or $0.62 on a per share basis. As we've discussed before, a key part of our growth strategy is to develop and commercialize innovative therapies for underserved patients in a capital and resource efficient manner. To that end, we've been disciplined managing our expenses as we've advanced multiple programs into and through Phase 3. With approximately $121 million in cash, cash equivalents and investments as of September 30th, we are well positioned ahead of important milestones and catalysts. We expect this cash to fund planned operations through 2024 before potential commercialization in HDV. Importantly, we have access to additional nondiluted capital under our debt facilities that we entered into earlier this year. Eiger can access up to $35 million in additional cash, contingent on positive clinical and regulatory milestones across two tranches, which can be instrumental to fund our Lonafarnib HDV commercial launch expenses.

    我們公佈第三季淨虧損2,710萬美元,即每股虧損0.62美元。正如我們之前所述,我們成長策略的關鍵在於以有效利用資本和資源的方式,為服務不足的患者群體開發和商業化創新療法。為此,我們嚴格控制支出,並將多個項目推進至第三期臨床試驗階段。截至9月30日,我們擁有約1.21億美元的現金、現金等價物和投資,這使我們能夠更好地應對重要的里程碑和催化劑。我們預計這筆現金足以支持我們計劃營運至2024年,之後HDV可能會商業化。重要的是,我們可以透過今年稍早簽訂的債務融資協議獲得額外的非稀釋性資金。 Eiger公司最多可獲得3500萬美元的額外現金,具體取決於兩個階段的臨床和監管里程碑的進展情況,這對於我們Lonafarnib HDV的商業化上市至關重要。

  • We'll now open up the call for Q&A. Operator, please provide the instructions for the Q&A portion of the call.

    現在開始問答環節。接線員,請提供問答環節的說明。

  • Operator

    Operator

  • (Operator Instructions) And our first question comes from the line of Maurice Raycroft of Jefferies.

    (操作說明)我們的第一個問題來自傑富瑞集團的莫里斯‧雷克羅夫特。

  • Maury Raycroft - Analyst

    Maury Raycroft - Analyst

  • Congrats on the progress, and thanks for taking my questions. I was going to ask just about the composite endpoint data that you have on Slide 13. If you can talk about reflective or similar these patients are to your Phase 3 population. And is there anything you can say about baseline viral load or other baseline variables, and how these can end up impacting the Phase 3 results?

    恭喜取得的進展,感謝您回答我的問題。我原本想問的是關於您在第13張投影片上展示的複合終點數據。您能否談談這些患者與您的第三期臨床試驗族群有何相似之處?另外,您能否談談基線病毒量或其他基線變量,以及這些因素最終會如何影響第三期臨床試驗的結果?

  • David Cory - President, CEO

    David Cory - President, CEO

  • And I will turn that one to Ingrid Choong. Ingrid?

    我會把這個問題轉給英格麗德·鐘。英格麗德?

  • Ingrid Choong - Senior Vice President, Clinical Development

    Ingrid Choong - Senior Vice President, Clinical Development

  • The Phase 3 baseline characteristics, those patient population is very similar to what we previously thought in Phase 2. Regarding the specifics of the baseline characteristics, we put out an abstract at an EASL earlier this year that did share that mean HDV RNA, for example, in D-LIVR is around five logs. And we also shared what the ALT baseline characteristics are as well and we certainly will be sharing additional information when topline results come out next month.

    第三階段的基線特徵,即患者族群,與我們先前在第二階段的預期非常相似。關於基線特徵的具體細節,我們在今年早些時候的EASL會議上發表了一篇摘要,其中提到,例如,D-LIVR組的平均HDV RNA水平約為5個對數級。我們也分享了ALT的基線特徵,我們肯定會在下個月公佈主要結果時分享更多資訊。

  • Maury Raycroft - Analyst

    Maury Raycroft - Analyst

  • And so nothing additional you�d say just on how some of those baseline characteristics could potentially impact the results versus what you've already shown with the Phase 2 composite data on Slide 13?

    所以,除了投影片 13 中所顯示的第二階段綜合資料之外,您沒有其他要補充說明這些基準特徵可能會如何影響結果嗎?

  • Ingrid Choong - Senior Vice President, Clinical Development

    Ingrid Choong - Senior Vice President, Clinical Development

  • So far, like I said, all of the -- what we've seen as the baseline characteristics from Phase 3 is very comparable to what's in Phase 2 for cirrhotic, for example, around 30% of patients are already cirrhotic. I think that's one of the important things of ensuring that your Phase 3 entry and exclusion criteria are very similar to your Phase 2. Other criteria like patients who are previously on Peginterferon Alpha, also was very comfortable from Phase 2 to Phase 3.

    正如我之前所說,到目前為止,我們從3期臨床試驗中觀察到的所有基線特徵都與2期臨床試驗中的特徵非常相似。例如,對於肝硬化患者,大約30%的患者已經患有肝硬化。我認為確保3期臨床試驗的入組與排除標準與2期臨床試驗非常相似至關重要。其他標準,例如先前接受過聚乙二醇幹擾素α治療的患者,也與2期臨床試驗的結果非常吻合。

  • David Cory - President, CEO

    David Cory - President, CEO

  • I'll just add, Maury, that, as you know, the composite endpoint of greater than or equal to a two log decline in HDV RNA, we believe based on the Phase 2 data that we should see those kinds of reductions in viral load, irrespective of whether patients come in with high viral load or high baseline or lower baseline, whether or not the patient would ultimately get negative or become undetectable, obviously, maybe influenced by their baseline viral loads. But our ability to achieve that two log decline, we believe is consistent across baseline viral loads. And then of course, ALT, we believe typically follows HDV RNA levels. And so we have high expectations on reduction in ALT or normalization of liver enzymes as well.

    莫里,我補充一點,如你所知,我們基於二期臨床試驗數據認為,無論患者入院時的病毒載量高低,無論基線病毒載量高低,最終是否轉陰或達到檢測不到的程度,我們都應該看到病毒載量出現這種程度的下降。當然,基線病毒量可能會影響最終結果。但我們相信,無論基線病毒量如何,我們都能穩定地實現病毒量下降兩個對數單位。此外,我們認為ALT水平通常與HDV RNA水平呈正相關。因此,我們對ALT水平的降低或肝酵素的正常化也抱有很高的期望。

  • Maury Raycroft - Analyst

    Maury Raycroft - Analyst

  • And I wanted to ask one other follow-up question. There was some impact related to sites in the Ukraine and Russia, I believe. Can you say where you're at with Phase 3 data collection, what final numbers will be included in your analyses, and if the database is locked or if you have line of sight to database lock?

    我還想問一個後續問題。我相信,烏克蘭和俄羅斯的站點受到了一些影響。您能否說明一下第三階段資料收集的進展情況,最終分析中將包含哪些數據,以及資料庫是否已鎖定,或者您是否能夠看到資料庫鎖定狀態?

  • Ingrid Choong - Senior Vice President, Clinical Development

    Ingrid Choong - Senior Vice President, Clinical Development

  • So early on in the Ukraine, Russian conflict back in February, we did some sensitivity analyses and showed that even if we were to lose all the patients who were randomized to Ukraine that we would still be more than adequately powered to show statistical significance of either of the Lonafarnib containing regimens over placebo. Today, we've had no impact on the Russian sites on patients. And again, we haven't -- while we were planning for potential losing all patients for Ukraine, we've only lost a subset. So we're still more than adequately powered to show statistical significance against either arm.

    早在二月烏克蘭與俄羅斯衝突初期,我們就進行了一些敏感性分析,結果表明,即使我們失去所有隨機分配到烏克蘭的患者,我們仍然有足夠的統計效力來證明兩種含洛那法尼的治療方案在統計學上優於安慰劑。目前,俄羅斯的患者並未受到影響。而且,儘管我們之前預計烏克蘭的患者可能會全部流失,但實際上隻流失了一部分。因此,我們仍有足夠的統計效力來證明兩種治療方案在統計上優於安慰劑。

  • David Cory - President, CEO

    David Cory - President, CEO

  • We haven't guided on database lock yet, Maury. But to the extent that providing guidance that we plan to announce topline data in December helps, hopefully that gives you a straight line between today and sometime in December.

    莫里,我們還沒有公佈資料庫鎖定的具體資訊。但是,我們計劃在12月公佈主要數據,這或許能幫助你更好地理解從今天到12月這段時間的大致關係。

  • Ingrid Choong - Senior Vice President, Clinical Development

    Ingrid Choong - Senior Vice President, Clinical Development

  • So we are on track to still having a topline data. We've been -- this is a large study and we've been cleaning and querying the database since the early part of this year and feel really good about having top line data by December.

    所以我們目前仍有望獲得初步數據。這是一項大型研究,我們從今年年初就開始清理和查詢資料庫,對12月份取得初步資料非常有信心。

  • Operator

    Operator

  • And your next question comes from the line of Brian Skorney of Baird.

    你的下一個問題來自 Baird 公司的 Brian Skorney。

  • Charlie Moore - Analyst

    Charlie Moore - Analyst

  • This is Charlie on for Brian. We wanted to know how you were thinking about the CRL or Hepcludex . And if you think that will have any impact on the HDV commercial opportunity for your products?

    這裡是查理,替布萊恩發言。我們想知道您對CRL或Hepcludex的看法。您認為這會對您產品的HDV商業機會產生任何影響嗎?

  • David Cory - President, CEO

    David Cory - President, CEO

  • As you can imagine, we're not aware of bulevirtide timing or the CRL that Gilead announced related to their program. But we do plan to provide more details on our regulatory strategy and timelines following our announcement of D-LIVR results in December. This is a key strategy obviously and priority for Eiger.

    如您所想,我們目前尚不了解bulevirtide的上市時間,也不了解吉利德公司就其專案發布的完全回覆函(CRL)。但我們計劃在12月公佈D-LIVR試驗結果後,提供更多關於我們監管策略和時間表的細節。這顯然是Eiger公司的關鍵策略和優先事項。

  • Operator

    Operator

  • Your next question comes from the line of Bert Hazlett of BTIG.

    你的下一個問題來自 BTIG 的 Bert Hazlett。

  • Bert Hazlett - Analyst

    Bert Hazlett - Analyst

  • Apologies if this has been addressed. But could you just remind us of the potential for maybe more rapid enrollment of LIMT-2, the Peginterferon lambda. Kind of what pushes and pulls are in place in that trial that might help enrollment relative to D-LIVR?

    如果這個問題之前已經討論過,請見諒。但您能否提醒我們一下,LIMT-2(聚乙二醇幹擾素λ)試驗的入組速度可能更快?該試驗有哪些促進和限制因素,可能有助於其相對於D-LIVR試驗更快招募患者?

  • David Cory - President, CEO

    David Cory - President, CEO

  • Thanks for joining us today. And that's a great question. I'll turn that one over to Ingrid.

    感謝您今天收看我們的節目。這是一個很好的問題,我把這個問題交給英格麗來回答。

  • Ingrid Choong - Senior Vice President, Clinical Development

    Ingrid Choong - Senior Vice President, Clinical Development

  • The Phase 3 LIMT-2 study, it's a much smaller, more straightforward study compared to D-LIVR only 150 patients planned across 12 countries across 50 sites. We've picked these 50 sites from the best performing sites from D-LIVR. So this will definitely facilitate more expeditious enrollment. Also the inclusion and exclusion criteria in LIMT-2 is much more or less compared to that of D-LIVR based on learnings. For example, in D-LIVR because we -- part of our composite endpoint is a two log decline in HDV RNA, we are requiring all patients to have at least a 2.5 log HDV RNA at study entry for D-LIVR. In the case of LIMT-2, since the primary endpoint is being below the limit of quantitation, patients only have to have unquantifiable HDV RNA at study entry. So that's just one example. Another example is all patients on both D-LIVR and LIMT-2 must have suppressed HDV DNA upon study entry, and that criteria for -- that�s finding suppressed HDV DNA is much higher in LIMT-2, so it's 20 IUs per ml in the case of D-LIVR and 100 IUs per ml in LIMT-2. And again, these are just learnings and the benefit of having, first, having one D-LIVR before LIMT-2.

    與D-LIVR相比,LIMT-2 III期研究規模更小、流程更直接,計畫僅在12個國家的50個研究中心招募150名患者。我們從D-LIVR研究中表現最佳的研究中心中挑選了這50個研究中心,這無疑將有助於加快病患招募速度。此外,根據以往經驗,LIMT-2的納入與排除標準也比D-LIVR更為寬鬆。例如,在D-LIVR研究中,由於我們的複合終點之一是HDV RNA下降2個對數單位,因此我們要求所有患者在入組時HDV RNA至少下降2.5個對數單位。而在LIMT-2研究中,由於主要終點是HDV RNA低於定量限,因此患者只需在入組時HDV RNA無法定量即可。以上僅舉一例。另一個例子是,所有參與D-LIVR和LIMT-2研究的患者在入組時都必須HDV DNA受到抑制,而LIMT-2研究中HDV DNA受到抑制的標準要高得多,D-LIVR研究的標準是20 IU/ml,而LIMT-2研究的標準是100 IU/ml。再次強調,這些只是經驗教訓,也是在參與LIMT-2研究之前先進行一次D-LIVR研究的益處所在。

  • David Cory - President, CEO

    David Cory - President, CEO

  • We definitely learned a lot from the Phase 3 D-LIVR study across over 20 countries and 100 sites, and those learnings we've all applied in the LIMT-2 lambda study for HDV. And look forward to obviously providing more guidance after we have completed activation of all roughly 50 sites and will communicate in the future.

    我們從涵蓋20多個國家、​​100多個研究中心的D-LIVR III期研究中獲益匪淺,並將這些經驗應用到了針對HDV的LIMT-2 lambda研究中。我們期待在完成所有約50個研究中心的啟動後,提供更多指導,並會在未來進行溝通。

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Your next question comes from the line of Michael Higgins of Ladenburg.

    你的下一個問題來自拉登堡的麥可希金斯家族。

  • Farhana Sakloth - Analyst

    Farhana Sakloth - Analyst

  • This is Farhana on behalf of Michael. We have a question basically on the Delta Cure Meeting�

    我是法哈娜,代表麥可。我們有一個關於Delta Cure會議的問題。

  • David Cory - President, CEO

    David Cory - President, CEO

  • Farhana, could you repeat that again?

    法哈娜,你能再說一次嗎?

  • Farhana Sakloth - Analyst

    Farhana Sakloth - Analyst

  • I was just talking to you guys. Can you hear me now?

    我剛才在跟你們說話呢。現在能聽到我說話嗎?

  • David Cory - President, CEO

    David Cory - President, CEO

  • Yes.

    是的。

  • Farhana Sakloth - Analyst

    Farhana Sakloth - Analyst

  • We wanted to know a little bit more about your participation of the Delta Cure Meeting. I guess what can you share about what you learned there and what sort of feedback did you get on Eiger�s program.

    我們想進一步了解您參加Delta Cure會議的情況。您能否分享一下您在會上學到了什麼,以及您對Eiger的專案有哪些回饋?

  • David Cory - President, CEO

    David Cory - President, CEO

  • Ingrid actually was in attendance with the clinical team in Milan at the Delta Cure Meeting, and it was an amazing event. And as Ingrid pointed out, it's the first actually international meeting specifically focused on hepatitis delta virus infection, which we think portend great things to come in terms of focus in this therapeutic area. And Ingrid, I'll let you comment on some of the experiences and learnings out of Delta Cure.

    英格麗德當時和臨床團隊一起參加了在米蘭舉行的Delta Cure會議,那真是一次令人難忘的盛會。正如英格麗所指出的,這是首個真正意義上專門聚焦於丁型肝炎病毒感染的國際會議,我們認為這預示著該治療領域未來將取得更大的發展。英格麗德,接下來就請你談談你在Delta Cure會議上的一些經驗和收穫吧。

  • Ingrid Choong - Senior Vice President, Clinical Development

    Ingrid Choong - Senior Vice President, Clinical Development

  • Sure. Delta Cure was held for two days, in the early part of October. There was 160 in person attendees with 250 people participating by Zoom. And again, this was the first and only medical meeting focused solely on Delta. Most of the attendees were key opinion leaders. There was also pharma represented in addition to Eiger, there was Gilead, J&J, Vir and then also some diagnostics companies as well.

    當然。 Delta Cure 會議於十月初舉行,為期兩天。共有 160 位現場與會者,另有 250 人透過 Zoom 線上參會。再次強調,這是第一個也是唯一一個完全專注於 Delta 的醫學會議。大多數與會者都是行業意見領袖。除了 Eiger 之外,還有 Gilead、強生、Vir 等製藥公司以及一些診斷公司也派代表出席。

  • So it was one and a half days of presentations. The first day were oral presentations really just talking about disease space and the need for therapies and then the second half day was focused on pharma, giving updates on programs. Eiger presented on Lonafarnib, as well as Peginterferon lambda. And ultimately, there's just a lot of excitement around the space now with data coming out across from Bill [Everett] as well as Lonafarnib ritonavir and Peginterferon lambda, and really discussing the need for potentially combination therapies to really be able to conquer HDV, which is a very serious and virulent viral hepatitis.

    所以,會議持續了一天半。第一天主要是口頭報告,主要討論疾病領域和治療需求;後半天則專注於製藥公司,介紹最新的專案進展。 Eiger介紹了Lonafarnib和聚乙二醇幹擾素λ。最終,隨著Bill Everett公佈的數據,以及Lonafarnib、利托那韋和聚乙二醇幹擾素λ的研發進展,目前整個領域都充滿了活力。會議重點討論了聯合療法的必要性,以真正攻克HDV——一種非常嚴重且毒性極強的病毒性肝炎。

  • David Cory - President, CEO

    David Cory - President, CEO

  • And I'll add Farhana that, I think part of the reason that the host of the delta cure meeting Dr. Heiner Wedemeyer out of Hannover, Germany and Dr. Pietro Lampertico out of Milan, Italy, two major key opinion leaders in the HDV space. I think the reason that they wanted to advance with a program like this in part is because now in addition to Eiger, as Ingrid mentioned, Vir is now in the HDV development space as well as Gilead, J&J, Assembly, Albireo, and I'm sure I'm leaving a few companies out. But the pipeline of programs, albeit earlier stage, Lonafarnib ritonavir and in combination with Alpha interferon is obviously very late stage. But many early stage programs, I think, which is terrific for the future and provides hope for patients with HDV.

    我還要補充一點,Farhana,我認為Delta Cure會議的主辦方之所以邀請了來自德國漢諾威的Heiner Wedemeyer博士和來自義大利米蘭的Pietro Lampertico博士——兩位HDV領域的重要意見領袖——參與,部分原因在於,正如Ingridombly、AlEiger領域之外,Vir、Gilead、強生、Ambly、Alfire雖然目前這些研發項目還處於早期階段,但Lonafarnib利托那韋和α幹擾素聯合療法顯然已經處於後期階段。不過,許多早期研發計畫也取得了進展,我認為這對未來來說是件好事,也為HDV患者帶來了希望。

  • Farhana Sakloth - Analyst

    Farhana Sakloth - Analyst

  • Can I just ask one more quick thing, maybe we missed so if you could just clarify. So Avexitide, it looks like we're just screening patients, right? There are no patients enrolled.

    我還能再問一個問題嗎?可能是我們漏掉了什麼,所以如果您能解釋一下就太好了。 Avexitide,看起來我們只是在篩選患者,對嗎?目前還沒有患者入組。

  • David Cory - President, CEO

    David Cory - President, CEO

  • Farhana, that�s correct. We had not yet enrolled patient in the Avexitide AVANT program. We're undertaking all of the enabling work to be able to activate sites and screen patients, and we'll be able to provide updates once we have more to say on that.

    Farhana,你說得對。我們尚未招募患者參與Avexitide AVANT計畫。我們正在進行所有必要的準備工作,以便啟動研究中心並篩選患者,一旦有更多進展,我們會及時發布最新消息。

  • Eldon Mayer - Chief Commercial Officer

    Eldon Mayer - Chief Commercial Officer

  • But I will say that the Congenital Hyperinsulinism International foundation recently held a benefit afternoon and evening in Montclair, New Jersey, which was attended by key opinion leaders and investigators from both Children's Hospital of Philadelphia, as well as Cook Children's. It was an amazing event, both for fundraising for supporting Congenital Hyperinsulinism International but also for multiple pharma companies in the congenital hyperinsulinism development space to interact with key opinion leaders, patients, families and investigators. And I think this is another exciting area that we definitely are very motivated to provide additional updates in the near future and will do so.

    但我必須說,先天性高胰島素血症國際基金會最近在新澤西州蒙特克萊爾舉辦了一場慈善下午茶和晚宴,費城兒童醫院和庫克兒童醫院的重要意見領袖和研究人員都出席了此次活動。這是一次非常棒的活動,不僅為先天性高胰島素血症國際基金會籌集了資金,也為多家從事先天性高胰島素血症藥物研發的製藥公司提供了一個與重要意見領袖、患者、家屬和研究人員交流的平台。我認為這是另一個令人振奮的領域,我們非常有動力在不久的將來提供更多最新進展,並且一定會這樣做。

  • Farhana Sakloth - Analyst

    Farhana Sakloth - Analyst

  • And then is 2024 a fair estimate for data?

    那麼,2024 年的資料預測是否合理?

  • David Cory - President, CEO

    David Cory - President, CEO

  • For the Avexitide AVANT program, we will complete activation of sites and begin enrolling patients and then provide more guidance, Farhana, on next steps for enrollment and obviously, then timelines for site on data.

    對於 Avexitide AVANT 項目,我們將完成站點的啟動並開始招募患者,然後 Farhana 將提供更多關於招募後續步驟的指導,當然還有站點數據的時間表。

  • Operator

    Operator

  • And I'm not showing any further questions. I would now like to call back to David Cory for any further remarks.

    我不再提問了。現在我想請大衛·科里先生再補充一些內容。

  • David Cory - President, CEO

    David Cory - President, CEO

  • Certainly, and thank you very much. In closing, I just want to make a few comments. We're very excited that the unblinding and reporting of top line data from the D-LIVR study is just weeks away, and we look forward to hosting an investor call when we announce the topline results.

    當然,非常感謝。最後,我還有幾點要補充。我們非常高興D-LIVR研究的揭盲和主要數據公佈就在幾週之內,我們期待在公佈主要結果時召開投資者電話會議。

  • This landmark D-LIVR study provides multiple paths to registration of Lonafarnib based regimens, which we believe are well differentiated from other therapeutics in development. We continue to execute across our pipeline of multiple FDA designated breakthrough therapy programs in Phase 3, which have the potential to deliver both patient and shareholder value. And of course, none of this would be possible without our team of dedicated people.

    這項具有里程碑意義的D-LIVR研究為基於洛那法尼的治療方案的註冊提供了多種途徑,我們相信這些方案與其他在研療法有著顯著差異。我們正持續推動多項已獲FDA認定為突破性療法的III期臨床試驗項目,這些項目可望為患者和股東創造價值。當然,這一切都離不開我們敬業的團隊。

  • So I'd like to thank everyone for their relentless efforts across our programs, not only at Eiger but our investigators, our patient and advocacy support groups and of course, thank all of you for joining us today on our call. Have a great day.

    所以,我要感謝我們所有計畫小組的每一位成員,感謝他們不懈的努力,不僅是艾格研究所的同事,還有我們的研究人員、病人和權益倡導支持團體。當然,也要感謝今天所有參加我們電話會議的各位。祝大家今天過得愉快。

  • Operator

    Operator

  • Thank you presenters. And this concludes today's conference call. You may now disconnect.

    謝謝各位發言人。今天的電話會議到此結束,您可以斷開連線了。