Seres Therapeutics Inc (MCRB) 2025 Q3 法說會逐字稿

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  • Operator

    Operator

  • Good day, everyone, and thank you for standing by. My name is RG, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q3 2025 Seres Therapeutics results and business updates. (Operator Instructions)

    大家好,感謝大家的耐心等待。我叫RG,今天我將擔任你們的會議接線生。在此,我謹代表 Seres Therapeutics 向大家介紹 2025 年第三季業績和業務最新進展。(操作說明)

  • Thank you. I would now like to turn the call over to Dr. Carlo Tanzi of Investor Relations. Please go ahead.

    謝謝。現在我將把電話交給投資者關係部門的卡洛·坦齊博士。請繼續。

  • Carlo Tanzi - Investor Relations

    Carlo Tanzi - Investor Relations

  • Thank you, and good morning. Today, before market opened, we issued a press release with our third quarter 2025 financial results and business updates available on the investors and news section of our website. We've also posted an updated corporate presentation.

    謝謝,早安。今天,在市場開盤前,我們發布了一份新聞稿,其中包含了我們 2025 年第三季的財務業績和業務更新,可在我們網站的投資者和新聞版塊查看。我們也發布了更新後的公司介紹。

  • Before we begin, I'd like to remind everyone that we will be making forward-looking statements, including statements around the results of our current or planned clinical trials, studies and data readouts, our product candidates and their potential benefits, development plans and potential commercial opportunities, interactions with and feedback from the FDA, our ability to secure an R&D or other partnership and/or generate or obtain additional capital, financing or other resources, our planned strategic focus and operating plans, cost reduction actions and anticipated benefits and cash runway, the timing of any of the foregoing and other statements which are not historical facts.

    在開始之前,我想提醒大家,我們將發表一些前瞻性聲明,包括關於我們目前或計劃進行的臨床試驗、研究和數據解讀的結果,我們的候選產品及其潛在益處,開發計劃和潛在的商業機會,與FDA的互動和反饋,我們獲得研發或其他合作夥伴關係和/或產生或獲得額外資金、融資或其他資源的能力,我們計劃的策略

  • Actual results may differ materially due to various risks and uncertainties and other important factors described under risk factors in our recent SEC filings. We undertake no obligation to update these statements, except as required by law. On today's call with prepared remarks are Marella Thorell, our Co-Chief Executive Officer and Chief Financial Officer; and Dr. Matthew Henn, our Chief Scientific Officer.

    實際結果可能因各種風險和不確定性以及我們在近期提交給美國證券交易委員會的文件中「風險因素」部分所述的其他重要因素而與預期有重大差異。除法律另有規定外,我們不承擔更新這些聲明的義務。今天出席電話會議並發表演講的有:我們的聯合執行長兼財務長 Marella Thorell;以及我們的首席科學官 Matthew Henn 博士。

  • Additional members of the management team, including Tom DesRosier, Co-CEO and Chief Legal Officer; Terri Young, Chief Commercial and Strategy Officer; and Dr. Dennis Walling, SVP of Clinical Development, will be available during the Q&A portion of the call.

    管理團隊的其他成員,包括聯合執行長兼首席法律長 Tom DesRosier、首席商務和策略長 Terri Young 以及臨床開發高級副總裁 Dennis Walling 博士,將在電話會議的問答環節中出席。

  • And with that, I'll turn the call over to Marella.

    接下來,我將把電話交給馬雷拉。

  • Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

    Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

  • Thank you, Carlo, and good morning, everyone. We made good progress during the quarter. Our immediate priority remains advancing SER-155, our lead investigational, oral, live biotherapeutic for the prevention of bloodstream infections, or BSIs, in adults undergoing allo-HSCT into a Phase II study. We believe that results in this study, if positive, could represent a very meaningful value creation event for the company.

    謝謝你,卡洛,大家早安。本季我們取得了良好的進展。我們目前的首要任務仍是推動 SER-155 進入 II 期研究階段。 SER-155 是我們領先的在研口服活生物療法,用於預防接受異基因造血幹細胞移植 (allo-HSCT) 的成年人發生血流感染 (BSI)。我們相信,如果這項研究的結果為陽性,將為公司帶來非常有意義的價值創造。

  • SER-155 represents a first-in-class mechanistically differentiated approach to address infections, including bloodstream and antimicrobial resistant infections, which are among the causes of mortality in medically compromised patients. In the Phase Ib study, treatment with SER-155 led to an impressive 77% relative risk reduction in bacterial bloodstream infections, along with decreased antibiotic exposure and febrile neutropenia.

    SER-155 代表了一種首創的機制差異化方法,用於治療感染,包括血流感染和抗藥性感染,這些感染是醫學基礎薄弱患者死亡的原因之一。在 Ib 期研究中,使用 SER-155 治療可使細菌性血流感染的相對風險降低 77%,同時減少抗生素暴露和發燒性嗜中性白血球減少症。

  • The therapy is designed to decolonize gastrointestinal pathogens, improve epithelial barrier integrity and restore immune balance, addressing root causes to prevent BSIs and therefore, reduce antibiotic use, antimicrobial resistance and often severe or fatal outcomes. Based on our analysis of the commercial opportunity, we believe that SER-155 could transform how allo-HSCT patients are managed and result in meaningfully improved patient outcomes.

    該療法旨在清除胃腸道病原體,改善上皮屏障完整性,恢復免疫平衡,從根本上預防血流感染,從而減少抗生素的使用、抗菌素抗藥性以及通常嚴重的或致命的後果。根據我們對商業機會的分析,我們認為 SER-155 可以改變異體造血幹細胞移植患者的管理方式,並顯著改善患者的治療效果。

  • In September, we obtained further constructive feedback from the FDA on the SER-155 allo-HSCT program, which has received Breakthrough Therapy designation Phase II protocol. Based on the feedback received, we are pleased to have alignment on multiple key study parameters, including study size, dosing regimen, primary efficacy endpoint and the interim analysis plan.

    9 月,我們從 FDA 獲得了關於 SER-155 異體造血幹細胞移植計畫的進一步建設性回饋,該計畫已獲得突破性療法認定,並進入 II 期臨床試驗方案。根據收到的回饋,我們很高興在多個關鍵研究參數上達成一致,包括研究規模、給藥方案、主要療效終點和中期分析計劃。

  • We do not believe there are any gating items to commencing the study from a protocol standpoint and are incorporating FDA feedback into the protocol. Notably, given the planned study design and our experience in this therapeutic area, we expect to be able to efficiently generate Phase II data in allo-HSCT patients, and we estimate that we will obtain meaningful placebo-controlled clinical results from a planned interim analysis within 12-months of study initiation with commencement being funding dependent.

    我們認為從方案角度來看,進行這項研究沒有任何障礙,並且正在將 FDA 的回饋意見納入方案中。值得注意的是,鑑於計劃的研究設計以及我們在該治療領域的經驗,我們預計能夠高效地生成異基因造血幹細胞移植患者的 II 期數據,並且我們估計,我們將在研究啟動後的 12 個月內,通過計劃的中期分析獲得有意義的安慰劑對照臨床結果,而啟動時間取決於資金情況。

  • Beyond the initial allo-HSCT indication, we see significant expansion potential across other medically vulnerable populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T therapy recipients and other medically compromised patients such as those in the ICU who face similar infection risks and unmet needs.

    除了最初的異基因造血幹細胞移植適應症外,我們看到了在其他醫療脆弱人群中巨大的擴展潛力,包括自體造血幹細胞移植患者、中性粒細胞減少症的癌症患者、CAR-T 療法接受者以及其他面臨類似感染風險和未滿足需求的醫療受損患者,例如 ICU 中的患者。

  • Collectively, these represent a multibillion-dollar commercial opportunity in patients facing high unmet need and where there has been limited therapeutic innovation. As Matt will discuss, we also have an ongoing investigator-sponsored study at Memorial Sloan Kettering Cancer Center, evaluating SER-155 in an indication beyond infection that is of high interest, and we look forward to obtaining initial clinical results in early 2026 that may highlight the potential of SER-155 in immune-related negative clinical outcomes.

    總的來說,這些都代表著數十億美元的商業機會,能夠滿足患者群體中尚未得到充分滿足的需求,並為他們提供有限的治療創新。正如 Matt 將要討論的那樣,我們在紀念斯隆-凱特琳癌症中心也有一項正在進行的研究者贊助的研究,評估 SER-155 在感染以外的適應症中的應用,這引起了人們的高度關注。我們期待在 2026 年初獲得初步的臨床結果,這些結果可能會凸顯 SER-155 在免疫相關不良臨床結果的潛力。

  • While we advance SER-155 Phase II study start-up activities, we continue our efforts to seek capital in order to initiate the study and support our broader portfolio of product candidates with applications in inflammatory diseases. Advancing SER-155 is our top priority, and we continue to strive to obtain the resources needed to move the program forward.

    在推進 SER-155 II 期研究啟動活動的同時,我們繼續努力尋求資金,以啟動研究並支持我們更廣泛的、可應用於發炎性疾病的候選產品組合。推進 SER-155 專案是我們的首要任務,我們將繼續努力取得推進該專案所需的資源。

  • During the quarter, we also implemented targeted cost reduction measures, including a workforce reduction of approximately 25% to extend our cash runway and focus resources on core development priorities. We believe that the cost reduction actions, the resultant operating runway extension will provide us with additional opportunities to advance our strategic priorities.

    本季度,我們也實施了有針對性的成本削減措施,包括裁員約 25%,以延長現金流,並將資源集中在核心發展重點。我們相信,降低成本的措施以及由此帶來的營運跑道延長將為我們提供更多機會,以推進我們的策略重點。

  • With that, I'll turn it over to Matt.

    接下來,我將把麥克風交給馬特。

  • Matthew Henn - Executive Vice President, Chief Scientific Officer

    Matthew Henn - Executive Vice President, Chief Scientific Officer

  • Thank you, Marella. Seres continues to execute its R&D strategy with efficiency and discipline with a focus on expanding the reach of SER-155 and building on key clinical insights to advance our broader biotherapeutic pipeline. Our recent successes in clinical translation and leveraging external collaborations as well as securing non-dilutive funding allows us to evaluate important new opportunities for SER-155 in additional patient populations.

    謝謝你,瑪雷拉。Seres 繼續有效率、嚴謹地執行其研發策略,重點是擴大 SER-155 的應用範圍,並利用關鍵的臨床見解來推進我們更廣泛的生物治療產品線。我們最近在臨床轉化和利用外部合作方面取得的成功,以及獲得的非稀釋性資金,使我們能夠評估 SER-155 在其他患者群體中的重要新機會。

  • We are thrilled to have recently announced that Seres has received a non-dilutive award from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator or CARB-X, of up to $3.6 million. This award represents the second CARB-X grant to Seres and will support the development of an oral liquid formulation of SER-155, which is intended to expand future access to this biotherapeutic in medically vulnerable patients who cannot easily swallow capsules, including patients in intensive care units and some pediatric and elderly patients.

    我們很高興地宣布,Seres 已獲得對抗抗生素抗藥性細菌生物製藥加速器 (CARB-X) 提供的高達 360 萬美元的非稀釋性獎勵。這項獎項是 Seres 獲得的第二筆 CARB-X 資助,將支持 SER-155 口服液體製劑的開發,旨在擴大未來能夠讓那些難以吞嚥膠囊的體弱患者(包括重症監護病房的患者以及一些兒科和老年患者)獲得這種生物療法的機會。

  • Furthermore, we believe that this CARB-X award underscores the global recognition of the potential of our biotherapeutic approach to address antimicrobial resistance, a major global public health issue and a top strategic priority for CARB-X. Additionally, at the recent IDWeek conference, Seres presented new post-hoc analyses from our SER-155 Phase Ib study in allo-HSCT, which provided deeper insights into bloodstream infection patterns, antimicrobial resistance and clinical outcomes across treatment groups.

    此外,我們認為 CARB-X 的這項獎項凸顯了全球對我們生物療法在解決抗菌素抗藥性方面的潛力的認可,抗菌素抗藥性是一個重大的全球公共衛生問題,也是 CARB-X 的首要戰略重點。此外,在最近的 IDWeek 會議上,Seres 展示了我們 SER-155 Ib 期異體造血幹細胞移植研究的最新事後分析,該分析對不同治療組的血流感染模式、抗菌素抗藥性和臨床結果提供了更深入的見解。

  • These data further support SER-155's differentiated mechanism and its potential to reduce serious infections in patients with limited therapeutic options. Also notably, our collaboration with Memorial Sloan Kettering Cancer Center on an investigator-sponsored trial initiated by a clinician evaluating SER-155 in patients with immune checkpoint inhibitor-related enterocolitis, or irEC, continues to progress, and the study is currently enrolling subjects.

    這些數據進一步支持了 SER-155 的差異化機制及其在治療選擇有限的患者中減少嚴重感染的潛力。值得一提的是,我們與紀念斯隆-凱特琳癌症中心合作開展的由臨床醫生發起的、研究者贊助的試驗,旨在評估 SER-155 對免疫檢查點抑製劑相關腸炎 (irEC) 患者的療效,該試驗仍在繼續推進,目前該研究正在招募受試者。

  • irEC is among the most frequent and severe immune-related adverse events in recipients of immune checkpoint inhibitor therapy and can be observed in up to 50% of patients with rates varying based on cancer drug and treatment regimen. Immune checkpoint inhibitors can cause a wide range of immune-related adverse events with links to T cell biology and epithelial barrier inflammation, biological functions shown in our preclinical studies and clinical pharmacology data to be positively impacted by SER-155.

    免疫檢查點抑制劑治療中最常見的嚴重免疫相關不良事件之一是免疫相關不良事件,高達 50% 的患者會出現該不良事件,其發生率因癌症藥物和治療方案而異。免疫檢查點抑制劑可引起多種與免疫相關的不良事件,這些不良事件與 T 細胞生物學和上皮屏障發炎有關,而我們的臨床前研究和臨床藥理學數據表明,SER-155 對這些生物學功能有正面影響。

  • irEC can be a serious condition characterized by diarrhea, abdominal pain, cramping, dehydration and blood in the stool and may progress to more serious complications such as bowel perforation, toxic megacolon or death. Management of irEC includes corticosteroids and other immune-suppressive drugs and can require withholding immune checkpoint treatment. We expect data will be available from this study early next year.

    irEC 是一種嚴重的疾病,其特徵是腹瀉、腹痛、痙攣、脫水和便血,並可能發展為更嚴重的併發症,如腸穿孔、中毒性巨結腸或死亡。irEC 的治療包括使用皮質類固醇和其他免疫抑制藥物,並且可能需要暫停免疫檢查點治療。我們預計這項研究的數據將於明年初公佈。

  • We also continue to explore potential R&D partnerships to advance the development of our investigational live biotherapeutics in inflammatory and immune diseases, including ulcerative colitis and Crohn's disease. These represent large patient populations with a continued need for new mechanisms of action, in particular, therapies that can target epithelial barrier-driven inflammation and that are not immunosuppressive.

    我們也將繼續探索潛在的研發合作夥伴關係,以推進我們正在研究的用於治療發炎和免疫疾病(包括潰瘍性結腸炎和克隆氏症)的活體生物療法的開發。這些患者群體龐大,他們仍然需要新的治療機制,特別是能夠針對上皮屏障驅動的發炎且不具免疫抑製作用的療法。

  • Clinical and preclinical data generated through support from the Crohn's & Colitis Foundation support the potential use of our biotherapeutics to address these unmet medical needs and provide a new approach to treat these conditions, either as a monotherapy or combination therapy. We continue to advance our novel biotherapeutics using highly focused data-driven approach and look forward to continuing collaboration with our clinical and academic partners to bring important new therapies to patients in need.

    在克隆氏症和結腸炎基金會的支持下產生的臨床和臨床前數據支持我們的生物療法在解決這些未滿足的醫療需求方面的潛在用途,並為治療這些疾病提供新的方法,無論是作為單一療法還是聯合療法。我們將繼續運用高度聚焦的數據驅動方法推進新型生物療法的研發,並期待繼續與臨床和學術合作夥伴合作,為有需要的患者帶來重要的全新療法。

  • Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

    Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

  • Thank you, Matt. I'll now turn to the third quarter financial results. As a reminder, Seres has classified all historical operating results for the VOWST business within discontinued operations in the consolidated statement of operations for the comparative periods presented, and there was no ongoing activity in this quarter related to the discontinued operations.

    謝謝你,馬特。接下來我將介紹第三季的財務表現。提醒各位,Seres 已將 VOWST 業務的所有歷史經營業績歸類為已終止經營業務,並在所列比較期間的合併經營報表中予以說明,本季度與已終止經營業務相關的任何持續活動均已停止。

  • Seres reported net income from continuing operations of $8.2 million in Q3 2025 as compared to a net loss from continuing operations of $51 million in the third quarter of 2024. The results this quarter are comprised of a $22.5 million loss from operations, offset by a $27.2 million gain on the sale of VOWST, resulting primarily from the $25 million installment payment received as expected from Nestle during the third quarter.

    Seres 報告稱,2025 年第三季持續經營業務淨收入為 820 萬美元,而 2024 年第三季持續經營業務淨虧損為 5,100 萬美元。本季業績包括 2,250 萬美元的營運虧損,但被出售 VOWST 獲得的 2,720 萬美元收益所抵消,這主要源於第三季如期收到雀巢支付的 2,500 萬美元分期付款。

  • R&D expenses for this quarter were $12.6 million compared to $16.5 million in the third quarter of 2024, reflecting lower personnel and related costs, a decrease in platform investments and a reduction in clinical expenses resulting from the completion of the SER-155 Phase Ib study. G&A expenses were $9.5 million in the quarter compared to $12.7 million in Q3 2024, driven primarily by lower personnel and related expenses, including IT-related expenses.

    本季研發費用為 1,260 萬美元,而 2024 年第三季為 1,650 萬美元,反映出人員和相關成本降低、平台投資減少以及 SER-155 Ib 期研究完成導致的臨床費用減少。本季一般及行政費用為 950 萬美元,而 2024 年第三季為 1,270 萬美元,主要原因是人員及相關費用(包括 IT 相關費用)減少。

  • As of September 30, 2025, Seres had $47.6 million in cash and cash equivalents. Based on the company's current cash position, remaining VOWST transaction-related obligations and current operating plans, we expect to fund operations through the second quarter of 2026. To summarize, we are disciplined in managing our expenses and continue to work towards securing additional capital to support development activities.

    截至 2025 年 9 月 30 日,Seres 擁有 4,760 萬美元的現金及現金等價物。根據公司目前的現金狀況、剩餘的 VOWST 交易相關義務和目前的營運計劃,我們預計可以維持營運到 2026 年第二季。總而言之,我們在管理支出方面非常嚴謹,並將繼續努力爭取更多資金來支持發展活動。

  • In early 2026, we expect to obtain additional SER-155 clinical results, which could highlight therapeutic opportunities in a new patient population. We have also made progress advancing SER-155 preparation activities to conduct a robust Phase II study, commencement of which is funding dependent. Based on the design of the Phase II study and the scope of the opportunity, we believe that positive study results, if achieved, could lead to tremendous value creation.

    預計在 2026 年初,我們將獲得更多 SER-155 的臨床結果,這可能會凸顯在新患者群體中的治療機會。我們在推進 SER-155 的製備活動方面也取得了進展,以進行穩健的 II 期研究,但研究的啟動取決於資金。根據 II 期研究的設計和機會的範圍,我們相信,如果取得積極的研究結果,將會帶來巨大的價值創造。

  • Operator, you may now open the call for questions. Thank you.

    操作員,現在可以開始接受提問了。謝謝。

  • Operator

    Operator

  • (Operator Instructions) John Newman, Canaccord.

    (操作說明)約翰紐曼,Canaccord。

  • John Newman - Equity Analyst

    John Newman - Equity Analyst

  • You have some really interesting commentary on this IST at Sloan Kettering for immune checkpoint-related enterocolitis. I wonder if you could just talk to us a little bit more about anything you can tell us regarding the study design and also how you view the commercial opportunity there?

    您對斯隆-凱特琳癌症中心針對免疫檢查點相關腸炎的IST療法有一些非常有趣的評論。我想請您再詳細介紹這項研究的設計,以及您如何看待其中的商業機會?

  • Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

    Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

  • Sure. John, thank you for the question. We're very excited about the study as well. MSK initiated this study, and we're pleased to be looking at one of what could be potentially many different applications for SER-155. As you know, there is a significant unmet need in this patient population, and so we're eager for the results as well. To elaborate a little bit more on the design of the study, I'd like to turn it over to Dennis, and he can share a little bit about the significant impact to patients who are on ICI of the irEC side effect. Dennis?

    當然。約翰,謝謝你的提問。我們也對這項研究感到非常興奮。MSK 發起了這項研究,我們很高興能夠研究 SER-155 的眾多潛在應用之一。如您所知,該患者群體存在著巨大的未滿足需求,因此我們也渴望看到結果。為了更詳細地闡述這項研究的設計,我想把發言權交給丹尼斯,他可以分享 irEC 副作用對接受 ICI 治療的患者的重大影響。丹尼斯?

  • Dennis Walling - Senior Vice president of Clinical Development

    Dennis Walling - Senior Vice president of Clinical Development

  • Yes. Thank you, Marella. irEC is one of the most frequent and severe immune-related adverse events that patients experience in immune checkpoint inhibitor therapy. Up to 60% of patients with rates varying depending on the cancer treatment and regimen used can experience irEC. irEC can be a very serious condition, as Matt previously described, characterized by symptoms, including diarrhea and abdominal pain, cramping, dehydration, blood in the stool and can progress to more serious complications such as bowel perforation, toxic megacolon or even death.

    是的。謝謝你,Marella。 irEC是免疫檢查點抑制劑治療中最常見、最嚴重的免疫相關不良事件之一。高達 60% 的患者可能會出現免疫反應性腸道疾病(irEC),具體發生率取決於所使用的癌症治療方法和方案。正如 Matt 之前所描述的那樣,irEC 可能是一種非常嚴重的疾病,其症狀包括腹瀉、腹痛、痙攣、脫水、便血,並可能發展為更嚴重的併發症,例如腸穿孔、中毒性巨結腸甚至死亡。

  • And the patients who experience irEC are treated with corticosteroids and other immunosuppressive drugs and also have to withhold their immune checkpoint inhibitor therapy. So the impact of this condition is significant and affects a significant number of patients undergoing this type of treatment. So this is the importance of why the study was originally designed and set up by the collaborator at MSK.

    而患有 irEC 的患者則接受皮質類固醇和其他免疫抑制藥物治療,並且必須暫停免疫檢查點抑制劑治療。因此,這種情況的影響非常顯著,影響到接受此類治療的大量患者。這就是 MSK 的合作者最初設計和進行這項研究的重要性。

  • The study is a small Phase I open-label study. The readout from this study is expected to occur in early 2026 and will be comprised primarily of safety data, drug pharmacology data and diarrhea symptom response data, following these patients through approximately six-weeks on the study for those who have received SER-155 for irEC. Our hope is that we could see an impact on the diarrhea symptoms.

    這項研究是一項小型 I 期開放標籤研究。這項研究的讀數預計將於 2026 年初公佈,主要包括安全性數據、藥物藥理學數據和腹瀉症狀反應數據,研究將對這些接受 SER-155 治療 irEC 的患者進行約六週的隨訪。我們希望能夠看到腹瀉症狀有所改善。

  • And certainly, patients who would have improvement in the diarrhea symptoms without needing additional immunosuppressive therapy medications would be a very meaningful finding. So that type of a clinical outcome paired with the safety data and the drug pharmacology mechanistic data would be extraordinarily useful for us to help us plan and inform for any future development -- clinical development opportunities in this new indication.

    當然,如果患者無需額外使用免疫抑制療法藥物即可改善腹瀉症狀,這將是一個非常有意義的發現。因此,這種臨床結果與安全性數據和藥物藥理機制數據相結合,對於我們規劃和指導未來的任何發展——即該新適應症的臨床開發機會——將非常有幫助。

  • Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

    Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

  • John, I just want to spend a minute to ask Terri to comment on the second aspect of your question regarding the commercial opportunity.

    約翰,我只想花一分鐘時間請特里就你關於商業機會的第二個問題發表一下看法。

  • Teresa Young - Executive Vice President, Chief Commercial and Strategy Officer

    Teresa Young - Executive Vice President, Chief Commercial and Strategy Officer

  • Thanks, Marella. John, thanks again for the question. As Dennis outlined, and this is a very common side effect of a very commonly used class of medications across many tumor types in oncology, perhaps best evidenced by KEYTRUDA net sales last year of almost $30 billion and growing at 18% versus 2023. So these are highly used agents growing, will continue to grow, particularly as biosimilars become available in the class.

    謝謝你,瑪瑞拉。約翰,再次感謝你的提問。正如丹尼斯所概述的那樣,這是腫瘤學中許多腫瘤類型中非常常用的一類藥物非常常見的副作用,KEYTRUDA 去年的淨銷售額接近 300 億美元,並且預計到 2023 年將增長 18%,這或許是最好的證明。因此,這些高使用率藥物正在成長,並將繼續成長,特別是隨著該類別生物相似藥的出現。

  • In terms of the patient impact, just double-clicking a little bit on what Dennis said, it's not uncommon for patients to have to either pause or discontinue their cancer treatment altogether to go down this detour of addressing the enterocolitis. It frequently drives them into the hospital. It's also a key limitation on physicians' choice of using combination therapies, which may be highly effective for treating the different tumors they're trying to address.

    就對患者的影響而言,稍微補充一下丹尼斯所說的,患者不得不暫停或完全停止癌症治療,轉而治療腸炎的情況並不少見。它經常導致他們住院。這也限制了醫生選擇使用聯合療法,而聯合療法對於治療他們試圖解決的不同腫瘤可能非常有效。

  • But there's this nervousness or anxiety about using combination therapy or even increasing the dose to address the cancer. So we feel like we have a big problem here and a very nice solution to address it. We're very eager to get the data.

    但人們對使用聯合療法甚至增加劑量來治療癌症感到緊張或焦慮。所以我們覺得我們遇到了一個大問題,但也有一個非常好的解決方案來解決這個問題。我們非常渴望獲得這些數據。

  • Operator

    Operator

  • Joseph Thome, TD Cowen.

    Joseph Thome,TD Cowen。

  • Joseph Thome - Analyst

    Joseph Thome - Analyst

  • Maybe just a couple on the potential partnership deals. Can you talk a little bit about how much capital you would need to get to that initial SER-155 data within the 12-months of study initiation? And then I guess, secondly, anything that you can do to kind of convey confidence that you'll be able to achieve something within the next 6 months within your targeted cash runway?

    或許只是關於潛在的合作協議中的幾個例子。您能否談談在研究啟動後的 12 個月內獲得 SER-155 的初始數據需要多少資金?其次,我想問的是,您能否採取一些措施來展現您的信心,讓大家相信您能夠在未來 6 個月內,在既定的資金框架內實現一些目標?

  • And then maybe last, if you're able to comment, there obviously was a report during the quarter that Nestlé made a takeout offer. Are you able to comment on if that was authentic and maybe why that wasn't an appropriate choice at that time?

    最後,如果您能發表評論的話,顯然本季度有一份報告稱雀巢提出了收購要約。您能否評論一下這件事是否屬實,以及為什麼在當時這不是一個合適的選擇?

  • Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

    Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

  • Great. Joe, thank you for the question. So first of all, just to talk a little bit about the design of the Phase II study. Importantly, that interim analysis 12 months after the study start will allow us a capital-efficient and timely recovery of data, and we are pleased to get feedback from the FDA that they were in alignment with that approach.

    偉大的。喬,謝謝你的提問。首先,讓我們先簡單談談 II 期研究的設計。重要的是,在研究開始 12 個月後進行的中期分析將使我們能夠以高效利用資金的方式及時回收數據,我們很高興得到 FDA 的反饋,他們同意採用這種方法。

  • As to the specific capital needs, we haven't guided on that other than to say that the timing of that and the way that we've designed the study, we do feel that we'll get meaningful safety and efficacy data given the patient count in this study at that IA point. We continue to make obtaining a partnership or another source of capital as our highest priority for SER-155, our lead candidate.

    至於具體的資金需求,我們沒有給出具體指示,只是說,考慮到研究的時間安排和我們設計研究的方式,我們相信在 IA 階段,鑑於本研究的患者數量,我們將獲得有意義的安全性和有效性數據。我們將繼續把為我們主導的候選藥物 SER-155 尋求合作夥伴關係或其他資金來源作為首要任務。

  • So we are continuing to have interactions and looking at a variety of different sources from which that capital could be obtained. So while we can't comment on any specifics as to status, it remains our most important priority. With respect to your last question, we just make it a practice not to comment on rumors, Joe, so I can't comment specifically on that.

    因此,我們正在繼續進行溝通,並尋找各種不同的資金來源。因此,雖然我們無法就具體情況發表評論,但這仍然是我們最重要的優先事項。關於你最後一個問題,喬,我們一貫的做法是不對謠言發表評論,所以我無法就此作出具體評論。

  • Operator

    Operator

  • That ends our Q&A session, and we appreciate your participation. I will now turn the call back over to the management for closing remarks. Please go ahead.

    問答環節到此結束,感謝各位的參與。現在我將把電話轉回給管理階層,請他們作總結發言。請繼續。

  • Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

    Marella Thorell - Co-President, Co-Chief Executive Officer, Chief Financial Officer

  • Thank you. Thanks, everyone, for joining us this morning, and have a great day.

    謝謝。感謝各位今天早上收看,祝大家有美好的一天。

  • Operator

    Operator

  • Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

    女士們、先生們,今天的電話會議到此結束。感謝各位的參與。您現在可以斷開連線了。