Infinity Pharmaceuticals Inc (INFI) 2022 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the Infinity Pharmaceuticals conference call to discuss the company's Third Quarter 2022 Financial Results and Business Update. My name is Michelle, and I will be your operator for today's call. (Operator Instructions) Please be advised this call is being recorded at Infinity's request.

女士們、先生們，感謝你們的支持。歡迎參加 Infinity Pharmaceuticals 電話會議，討論公司 2022 年第三季財務業績和業務更新。我叫米歇爾，今天我將擔任您的電話接線生。 （操作員指示）請注意，此通話是應 Infinity 的要求錄製的。

Now I would like to introduce your host for today's call, Jayne Kauffman. Please go ahead.

現在我想介紹今天電話會議的主持人 Jayne Kauffman。請繼續。

Thank you, Michelle, and good morning, everyone. Welcome to today's call to discuss our third quarter 2022 financial results and the MARIO-3 data update that we announced in a separate press release earlier this morning. Both press releases are available on our website at infi.com. On the call with me today are Adelene Perkins, Chief Executive Officer and Chair; Larry Bloch, President; and Robert Ilaria, Jr., Chief Medical Officer. We will open up the call for Q&A following our remarks.

謝謝你，米歇爾，大家早安。歡迎參加今天的電話會議，討論我們 2022 年第三季的財務業績以及我們今天早上在另一份新聞稿中宣布的 MARIO-3 數據更新。這兩份新聞稿均可在我們的網站 infi.com 上查閱。今天與我一起通話的有執行長兼主席 Adelene Perkins；拉里·布洛赫（Larry Bloch），總裁；以及首席醫療官 Robert Ilaria, Jr.。我們將在發言後開放問答環節。

Please note that during this call, we may make forward-looking statements about our future expectations and plans, including clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and financial projections. Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the Risk Factors section of our annual report on Form 10-K for 2021 and in other filings we make with the SEC. These forward-looking statements represent our views only as of today and we caution you that we may not update them in the future, whether as a result of new information, future events or otherwise.

請注意，在本次電話會議中，我們可能會對我們的未來期望和計劃做出前瞻性陳述，包括臨床開發目標、我們候選產品的治療潛力、我們的策略計劃和財務預測。由於許多重要因素，我們的實際結果可能與我們今天的預測有重大差異，包括我們 2021 年 10-K 表年度報告的風險因素部分以及我們向美國證券交易委員會提交的其他文件中描述的考慮因素。這些前瞻性陳述僅代表我們截至今天的觀點，我們提醒您，無論由於新資訊、未來事件或其他原因，我們未來可能不會更新這些陳述。

Now I'd like to turn the call over to Adelene.

現在我想把電話轉給阿德琳。

Thanks, Jayne, and thank to everyone for joining us to review Infinity's third quarter 2022 business update. Today we are pleased to provide encouraging updated data from our single arm MARIO-3 Phase II trial evaluating eganelisib in combination with atezolizumab and nab-paclitaxel in patients with front-line metastatic triple negative breast cancer or TNBC.

謝謝，傑恩，也感謝大家與我們一起回顧 Infinity 2022 年第三季的業務更新。今天，我們很高興提供單臂 MARIO-3 II 期試驗的令人鼓舞的更新數據，該試驗評估了 eganelisib 聯合 atezolizumab 和 nab-paclitaxel 對一線轉移性三陰性乳腺癌或 TNBC 患者的療效。

We are encouraged by the updated results, which continued to show durable long-term clinical benefit for patients, which we will review shortly. As we disclosed on our second quarter earnings call, we have made entering into a strategic partnership to advance eganelisib development and pave the way to eventual approval, our top priority. We plan to initiate additional studies of eganelisib after putting a partnership in place to ensure that we and our partners are aligned on eganelisib's future development.

更新後的結果令我們感到鼓舞，它繼續顯示出對患者持久的長期臨床益處，我們很快就會對此進行審查。正如我們在第二季財報電話會議上所揭露的那樣，我們已將建立戰略合作夥伴關係以推進 eganelisib 的開發並為最終獲得批准鋪平道路作為我們的首要任務。我們計劃在建立合作關係後啟動對 eganelisib 的進一步研究，以確保我們和我們的合作夥伴在 eganelisib 的未來發展上保持一致。

Let me bring you up to date on our progress. Our business development discussions are directed towards an initial focused development plan in a randomized controlled setting. The benefit seen across a broad array of solid tumors in which eganelisib has been studied to date, including breast, urothelial, head and neck, ovarian and melanoma cancers, providing multiple potential future development path. It is our goal to announce a partnership and the focus of the prioritized clinical development plan for eganelisib in the third quarter of 2023.

讓我向您介紹一下我們的最新進展。我們的業務發展討論旨在隨機控制環境中製定初步的重點發展計劃。迄今為止，eganelisib 已在多種實體瘤中被研究，包括乳腺癌、尿路上皮癌、頭頸癌、卵巢癌和黑色素瘤，從而提供了多種潛在的未來發展途徑。我們的目標是在 2023 年第三季宣布合作夥伴關係以及 eganelisib 優先臨床開發計劃的重點。

Turning to the MARIO-3 data. With an additional year of data maturity since our last update at the San Antonio Breast Cancer Symposium in December 2021, there is encouraging evidence of a long-term benefit for patients relative to the IMpassion130 benchmark study. We are now able to report the 1-year progression-free survival rate for patients with both PD-L1 positive and PD-L1 negative tumors, which were promising for all patients regardless of PD-L1 status. This long-term benefit in patients with TNBC is consistent with the long-term benefits seen in other indications in which eganelisib has been studied. Additionally, there were no new safety signals during the extended period of treatment.

轉向 MARIO-3 資料。自從我們上次在 2021 年 12 月聖安東尼奧乳癌研討會上更新數據以來，數據又成熟了一年，有令人鼓舞的證據表明，與 IMpassion130 基準研究相比，患者將獲得長期益處。我們現在可以報告 PD-L1 陽性和 PD-L1 陰性腫瘤患者的 1 年無惡化存活率，這對所有患者來說都是有希望的，無論 PD-L1 狀態如何。 TNBC 患者的這種長期益處與 Eganelisib 在其他適應症研究中觀察到的長期益處一致。此外，在延長治療期間沒有出現新的安全訊號。

We were also pleased to report positive updated results from the randomized control MARIO-275 Phase II clinical study evaluating eganelisib plus nivolumab versus nivolumab in patients with second line platinum-resistant metastatic urothelial cancer during the third quarter. As we previously reported, the eganelisib combination showed approximately a doubling of patient overall survival at the 2-year landmark analysis compared to standard of care nivolumab monotherapy.

我們也高興地報告了第三季隨機對照 MARIO-275 II 期臨床研究的積極更新結果，該研究評估了 eganelisib 加 nivolumab 與 nivolumab 在二線鉑耐藥轉移性尿路上皮癌患者的療效。正如我們先前所報導的，與標準治療方案 nivolumab 單藥治療相比，eganelisib 組合療法在 2 年里程碑分析中顯示患者整體存活率大約增加了一倍。

Eganelisib has demonstrated promising clinical results across five oncology indications and treatment settings to date. The continued strength of our data across multiple indications provides solid evidence that eganelisib has the potential to be a transformative therapy in immuno-oncology for three key reasons. First, we have a first-in-class therapy with potent and specific on-target activity and translational data showing that target inhibition with eganelisib reprograms macrophages in the tumor micro environment reduces immune suppression and activate an anticancer immune response.

迄今為止，Eganelisib 已在五種腫瘤適應症和治療環境中顯示出良好的臨床效果。我們在多種適應症中持續表現強勁的數據提供了有力的證據，表明 Eganelisib 有可能成為免疫腫瘤學的變革性療法，主要原因有三。首先，我們擁有一流的治療方法，具有強效且特異的靶向活性和轉化數據，表明使用 eganelisib 進行靶向抑制可重新編程腫瘤微環境中的巨噬細胞，從而降低免疫抑制並激活抗癌免疫反應。

Second, the clinical data with eganelisib have demonstrated prolonged progression-free survival in multiple indications and extended overall survival over current standards of care in a randomized controlled trial that allowed us to see the distinct contribution of eganelisib over its combination drug partners.

其次，一項隨機對照試驗表明，eganelisib 在多種適應症中延長了無進展生存期，並且比目前的治療標準延長了總體生存期，這讓我們看到了 eganelisib 相對於其聯合用藥夥伴的獨特貢獻。

Third, and very importantly, eganelisib has been shown to have an acceptable and manageable safety profile in combination with other drugs, including in 2 and 3 drug combination regimen.

第三，非常重要的是，eganelisib 已被證明與其他藥物合併使用（包括 2 種和 3 種藥物合併治療方案）具有可接受且可控的安全性。

At this time, I'd now like to turn the call over to Dr. Ilaria to review our recent encouraging eganelisib data. Rob?

現在，我想將電話轉給 Ilaria 博士，讓他回顧我們最近令人鼓舞的 eganelisib 數據。搶？

Thank you, Adelene, and good morning. The objective of our MARIO-3 TNBC Phase II study was to evaluate the safety and efficacy of the addition of eganelisib to atezolizumab and nab-paclitaxel in frontline metastatic TNBC patients. Patients were enrolled in either PD-L1 positive or PD-1 negative tumor cohorts.

謝謝你，阿德琳，早安。我們的 MARIO-3 TNBC II 期研究的目的是評估在轉移性 TNBC 患者一線治療中添加 Eganelisib 和 Atezolizumab 和 Nab-Paclitaxel 的安全性和有效性。患者被納入 PD-L1 陽性或 PD-1 陰性腫瘤組。

The [alogipitic] criteria for MARIO-3 were designed to mirror the IMpassion130 study to facilitate benchmarking. It's important to note that the approval of immune checkpoint inhibitors in combination with chemotherapy in frontline metastatic TNBC have been limited to PD-L1 positive tumors. There are no immune checkpoint inhibitor regimens approved for patients with metastatic PD-L1 negative tumors, which represent approximately 2/3 of TNBC patients.

MARIO-3 的 [alogipitic] 標準旨在反映 IMpassion130 研究，以促進基準測試。值得注意的是，免疫檢查點抑制劑合併化療用於第一線轉移性 TNBC 治療的批准僅限於 PD-L1 陽性腫瘤。目前尚無針對轉移性 PD-L1 陰性腫瘤患者的免疫檢查點抑制劑方案獲得批准，這類患者約佔 TNBC 患者的 2/3。

As of October 8, 2022, 62 TNBC patients were enrolled and evaluable for safety, and 57 patients were evaluable for efficacy in MARIO-3 with a median duration of follow-up of 10 months. In the efficacy data set, 35 patients had PD-L1 negative tumors, 18 patients had PD-L1 positive tumors and 8 patients had tumors of undetermined PD-L1 status. We're pleased to share that we continue to see very encouraging and durable evidence of a progression-free survival benefit in this study.

截至 2022 年 10 月 8 日，MARIO-3 試驗中已有 62 名 TNBC 患者入組並可進行安全性評估，57 名患者可進行療效評估，中位追蹤時間為 10 個月。在療效資料集中，35名患者患有PD-L1陰性腫瘤，18名患者患有PD-L1陽性腫瘤，8名患者患有PD-L1狀態未確定的腫瘤。我們很高興地告訴大家，我們在這項研究中繼續看到了非常令人鼓舞和持久的無進展生存益處的證據。

In patients with PD-L1 negative tumors, we continue to see an improvement in median PFS, with a median PFS of 7.3 months in MARIO-3 compared to 5.6 months in IMpassion130, a 30% relative improvement. Even more importantly, we're also seeing evidence of potential long-term benefit with a 1-year PFS rate of 34.7%, although the 1-year PFS rate was not disclosed for the IMpassion130 PD-L1-negative population, it should be noted that the 1-year PFS rate in MARIO-3 PD-L1 negative tumors, a subgroup with inferior outcomes with immune checkpoint inhibitor therapy, exceeds the 23.7 1-year PFS rate for the IMpassion130 ITT, which of course, included patients with PD-L1 positive and negative tumors.

在 PD-L1 陰性腫瘤患者中，我們繼續看到中位 PFS 的改善，MARIO-3 的中位 PFS 為 7.3 個月，而 IMpassion130 的中位 PFS 為 5.6 個月，相對改善了 30%。更重要的是，我們也看到了潛在長期益處的證據，1 年 PFS 率為 34.7%，儘管 IMpassion130 PD-L1 陰性人群的 1 年 PFS 率尚未公佈，但值得注意的是，MARIO-3 PD-L1 陰性腫瘤（免疫檢查點抑製劑治療結果較差的亞組）的 1273 PD-L1 陰性腫瘤（免疫檢查點抑製劑治療結果較差的亞組）的 123973 年 2373 . -L1 陽性和陰性腫瘤患者。

In patients with PD-L1 positive tumors, we also observed evidence of potential long-term benefit with a 1-year PFS rate of 37.5% compared to 29.1% in IMpassion130, a 29% relative improvement. In addition to the encouraging 1-year PFS rate, we observed further evidence of antitumor activity of the eganelisib triplet in patients with PD-L1 positive tumors. The objective response rate was 66.7% compared to 58.9% in IMpassion130 largely driven by a higher complete response rate in MARIO-3 patients with PD-L1 positive tumors, 16.7% versus 10.3% of patients in IMpassion130.

在 PD-L1 陽性腫瘤患者中，我們也觀察到潛在長期益處的證據，1 年 PFS 率為 37.5%，而 IMpassion130 為 29.1%，相對改善率為 29%。除了令人鼓舞的 1 年 PFS 率之外，我們還觀察到 eganelisib 三聯體在 PD-L1 陽性腫瘤患者中具有抗腫瘤活性的進一步證據。客觀緩解率為 66.7%，而 IMpassion130 為 58.9%，這主要是因為 MARIO-3 PD-L1 陽性腫瘤患者的完全緩解率更高，MARIO-3 患者的完全緩解率為 16.7%，而 IMpassion130 患者的完全緩解率為 10.3%。

Lastly, the median duration of response was 11.7 months compared to 8.5 months in IMpassion130, a 38% relative improvement. We did not continue to see improvement in the median PFS and of the MARIO-3 PD-L1 positive population with a median PFS of 6.4 months compared to 7.5 months on IMpassion130. With the approval of pembrolizumab plus chemotherapy in patients with PD-1 positive tumors, this proved to be a challenging patient population to enroll, which provided us with a less robust sample size to characterize the median PFS compared to our PD-L1 negative patient cohort.

最後，中位反應持續時間為 11.7 個月，而 IMpassion130 為 8.5 個月，相對改善率為 38%。我們沒有繼續看到中位 PFS 和 MARIO-3 PD-L1 陽性人群的改善，中位 PFS 為 6.4 個月，而 IMpassion130 為 7.5 個月。隨著 PD-1 陽性腫瘤患者獲準使用派姆單抗聯合化療，這被證明是一個具有挑戰性的患者群體，與我們的 PD-L1 陰性患者群體相比，這為我們提供了不太穩健的樣本量來表徵中位 PFS。

Nonetheless, the 1-year PFS rate, an indicator of potential long-term benefit was very consistent across PD-L1 tumor status in MARIO-3, 37.5% in PD-L1 positive tumors, and 34.7% in PD-L1 negative tumors. These combined for a 1-year PFS rate of 36% in the MARIO-3 ITT, a 52% relative improvement over the 1-year PFS rate of 23.7% reported in the entire IMpassion130 population.

儘管如此，1 年 PFS 率（潛在長期益處的指標）在 MARIO-3 中的 PD-L1 腫瘤狀態下非常一致，PD-L1 陽性腫瘤為 37.5%，PD-L1 陰性腫瘤為 34.7%。綜合起來，MARIO-3 ITT 的 1 年 PFS 率為 36%，比整個 IMpassion130 人群報告的 1 年 PFS 率 23.7% 相對提高了 52%。

The updated safety analysis of the MARIO-3 TNBC triplet regimen remains consistent with expectations for the three component drugs and no new safety signals were observed during the extended time on treatment. The most common grade 3 or higher treatment-related adverse events were hepatic AEs at 24.2%, neutropenia AEs at 14.5% and skin and peripheral neuropathy adverse events, each at 11.3%. 25.8% patients discontinued treatment for treatment-related AEs, which for a triplet regimen compares favorably to the 19.1% reported in IMpassion130 for the atezolizumab and nab-paclitaxel doublet.

MARIO-3 TNBC 三聯療法的最新安全性分析與對三種成分藥物的預期一致，並且在延長治療期間未觀察到新的安全性訊號。最常見的 3 級或更高等級治療相關不良事件是肝臟不良事件（24.2%）、嗜中性白血球減少症不良事件（14.5%）以及皮膚和周邊神經病變不良事件（各 11.3%）。 25.8% 的患者因治療相關不良事件而停止治療，對於三聯療法而言，這一比例與 IMpassion130 中阿特珠單抗和白蛋白結合型紫杉醇雙聯療法報告的 19.1% 相比有所提高。

While hepatic AEs remain the most common grade 3 or higher treatment-related adverse events, when eganelisib is combined with an immune checkpoint inhibitor, they continue to be reversible within a relatively short amount of time often without corticosteroids. Bilirubin elevations was infrequent and we saw no evidence of Hy's law.

雖然肝臟不良事件仍然是最常見的 3 級或更高級別治療相關不良事件，但當 Eganelisib 與免疫檢查點抑制劑聯合使用時，它們可以在相對較短的時間內繼續逆轉，通常無需使用皮質類固醇。膽紅素升高並不常見，我們沒有看到海氏定律的證據。

In summary, the almost 1-year greater data maturity in MARIO-3 TNBC has provided us a new opportunity to gain insight into potential long-term benefit of the triplet regimen of eganelisib combined with atezolizumab and nab-paclitaxel with encouraging 1-year progression-free survival rates across tumor PD-L1 status. These findings build on the promising 2-year landmark overall survival data, Adelene described from our MARIO-275 randomized trial in second line platinum-resistant urothelial cancer.

總而言之，MARIO-3 TNBC 中近 1 年的數據成熟度更高，為我們提供了一個新的機會來深入了解 eganelisib 聯合 atezolizumab 和 nab-paclitaxel 的三聯方案的潛在長期益處，並在腫瘤 PD-L1 狀態下實現了令人鼓舞的 1 年無進展生存率。這些發現建立在有希望的 2 年里程碑式整體存活數據的基礎上，Adelene 描述了我們在二線鉑抗藥性尿路上皮癌中進行的 MARIO-275 隨機試驗。

Data from our Phase II studies are consistent with and built upon findings in our MARIO-1 Phase Ib study, where we demonstrated the potential for eganelisib to benefit patients refractory to immune checkpoint inhibitors, such as patients with squamous cell cancer of the head and neck. The totality of the eganelisib data across multiple tumor types supports important next steps in a robust, randomized clinical trial setting.

我們 II 期研究的數據與 MARIO-1 Ib 期研究的結果一致，並建立在該研究的基礎上，在該研究中，我們證明了 Eganelisib 有可能使對免疫檢查點抑製劑有抵抗力的患者受益，例如頭頸部鱗狀細胞癌患者。跨多種腫瘤類型的 eganelisib 數據總體支持在穩健的隨機臨床試驗環境中採取重要的後續步驟。

Now I'll turn the call over to Larry to review our third quarter financial results. Larry?

現在我將把電話轉給拉里來回顧我們第三季度的財務表現。拉里？

Thank you, Rob. During the third quarter, we continued to pursue a disciplined prudent approach to capital allocation. So at the end of the third quarter of 2022, Infinity had total cash of $47.2 million compared to $80.7 million at December 31, 2021.

謝謝你，羅布。第三季度，我們繼續採取嚴謹慎審慎的資本配置方式。因此，截至 2022 年第三季末，Infinity 的總現金為 4,720 萬美元，而 2021 年 12 月 31 日的總現金為 8,070 萬美元。

Research and development expenses for the third quarter 2022 were $7.7 million compared to $7.1 million at the same period in 2021. And this increase is primarily related to higher compensation expense due to additional staff to support the future development of eganelisib.

2022年第三季的研發費用為770萬美元，而2021年同期為710萬美元。這一增長主要與因增加員工以支持eganelisib的未來開發而導致的薪酬費用增加有關。

General and administrative expense was $3.5 million for the third quarter of 2022 as compared to $3.8 million in the same period in 2021. This increase was primarily due to a decrease in professional services.

2022 年第三季的一般及行政費用為 350 萬美元，而 2021 年同期為 380 萬美元。這一增長主要是由於專業服務費用的減少。

Net loss for the third quarter of 2022 was $10.7 million or a basic and diluted loss per common share of $0.12 compared to a net loss of $10.7 million or basic and diluted loss per common share of $0.12 in the same period in 2021. Infinity's financial guidance for 2022 remains unchanged.

2022 年第三季淨虧損為 1,070 萬美元，即每股基本虧損和稀釋虧損均為 0.12 美元，而 2021 年同期淨虧損為 1,070 萬美元，即每股基本虧損和稀釋虧損均為 0.12 美元。 Infinity 對 2022 年的財務指引保持不變。

We continue to expect net loss for 2022 to range from between $40 million and $50 million. And 2022 year-end cash to range from between $35 million and $45 million. These finance guidance does not include additional financing or business development activities even as our goal is to execute on eganelisib strategic analyst partnership to be announced in the first quarter of 2023.

我們繼續預期 2022 年淨虧損將在 4,000 萬美元至 5,000 萬美元之間。 2022 年底現金將在 3,500 萬美元至 4,500 萬美元之間。儘管我們的目標是執行將於 2023 年第一季宣布的 eganelisib 策略分析師合作夥伴關係，但這些財務指導並不包括額外的融資或業務發展活動。

At this time, we can open up the call for questions.

現在，我們可以開始提問了。

(Operator Instructions) And our first question comes from the line of Edward Tenthoff with Piper Sandler.

（操作員指示）我們的第一個問題來自 Piper Sandler 的 Edward Tenthoff。

Great. Thanks for the update on the MARIO data today. Should we be expecting a presentation at San Antonio Breast? Will you be presenting there? Or is this sort of the update for this year? And appreciate that and all the other guidance to that.

偉大的。感謝您今天對 MARIO 資料的更新。我們應該期待在聖安東尼奧乳癌中心進行演講嗎？您會在那裡演講嗎？還是這是今年的更新？並感謝這一點以及所有其他的指導。

Thank you, Ted, for the question. We -- this is the data update for MARIO-3. As you know, we have presented at San Antonio Breast Cancer Symposium for the last two years. And so we chose this year to present the data on this call so that we could have the most recent data cut to get the data out more quickly. As you know, there's a longer lead time toward that medical meeting.

謝謝泰德提出的問題。我們——這是 MARIO-3 的資料更新。如您所知，過去兩年我們都在聖安東尼奧乳癌研討會上發表演講。因此，我們選擇在今年的電話會議上展示數據，以便我們能夠獲得最新的數據，從而更快地獲取數據。如您所知，那次醫學會議的準備時間較長。

Yes, make a lot of sense. I appreciate it. And congrats on the data. It looks great.

是的，很有道理。我很感激。恭喜您獲得這些數據。看起來很棒。

Thank you.

謝謝。

And our next question comes from the line of Soumit Roy with JonesTrading.

我們的下一個問題來自 JonesTrading 的 Soumit Roy。

Just trying to understand the new 13 patients versus previous update. Is anything particular about these patients that pulled back the median PFS number? Or did the PD-L1 expression levels go up more than expected? Any color would be appreciated.

只是想了解新的 13 名患者與之前的更新情況。這些患者是否有什麼特殊情況導致中位 PFS 數下降？或者PD-L1表達量是否比預期上升得更多？任何顏色都會受到歡迎。

Thanks, Soumit. The most important update in this data is that it's more mature. And so that was what we were really focused on and are pleased to see the 1-year PFS rate, which we think is a most meaningful reflection of long-term benefit.

謝謝，Soumit。這個數據最重要的更新就是它更加成熟了。這就是我們真正關注的重點，我們很高興看到 1 年 PFS 率，我們認為這是對長期利益最有意義的反映。

But perhaps, Rob, you can elaborate a little bit further on the median PFS.

但是，羅布，也許您可以進一步詳細說明中位 PFS。

Sure. Last year, when we provided the data, we were updating data from almost a year ago. And one of the challenges in the median PFS, of course, is that's the middle value of whatever list of number of patients you have. And one of the challenging things that we had is that the PD-L1 positive patient population improved a bit more challenging to enroll. Once pembro chemo got approved, I think a lot of those patients were seeing in the community and not in a lot of the research centers.

當然。去年，當我們提供數據時，我們正在更新近一年前的數據。當然，中位 PFS 的挑戰之一是，它是您所擁有的患者數量清單的中間值。我們面臨的挑戰之一是 PD-L1 陽性患者群體的改善使得招募變得更具挑戰性。一旦派姆化療獲得批准，我認為許多患者都會在社區接受治療，而不是在研究中心。

So as a result, we weren't able to get as many patients in the PD-L1 positive group is negative. And as a result, that midpoint can really fluctuate a lot. And so last year, there were some patients who hadn't had even their first scan yet. So I think the challenge is a median PFS can really be variable when you have a smaller sample set compared to, for example, our PD-L1 negative side was almost twice what the positives were.

因此，我們無法獲得 PD-L1 陽性組中盡可能多的陰性患者。因此，中點確實會發生很大的波動。因此，去年有些患者甚至還沒有接受第一次掃描。因此，我認為挑戰在於，當樣本集較小時，中位 PFS 確實可能會發生變化，例如，我們的 PD-L1 陰性側幾乎是陽性側的兩倍。

And our last question comes from the line of Kalpit Patel with B. Riley.

我們的最後一個問題來自 B. Riley 的 Kalpit Patel。

This is Malcolm for Kalpit. So maybe focusing on your partnership discussions that are ongoing for UC versus TNBC, has there been any interest relatively higher in one indication versus the other? And maybe which do you anticipate being the first to advance to the next stage? And then I have a quick follow-up.

我是馬爾科姆，代表卡爾皮特。因此，也許重點關注您正在進行的 UC 與 TNBC 的合作討論，對於其中一種適應症相比，是否有人對另一種適應症的興趣相對較高？您預計哪一個會率先進入下一階段？然後我有一個快速的跟進。

Okay. Thank you for the question. Well, we're not in a position today to describe the specifics on the future of eganelisib's development plan until we put the partnership in place. We can tell you a few things that you might expect to see in the future development.

好的。謝謝你的提問。嗯，在我們建立合作關係之前，我們今天還無法描述 eganelisib 未來發展計畫的具體細節。我們可以告訴您一些您可能在未來的發展中看到的事情。

First is that it will be leveraging some of the encouraging data that we generated with eganelisib to date in one or more indications. The focus of the development will be in a randomized controlled setting so that we can very clearly show the contribution of eganelisib over its contribution regimen over standard of care. And three, it will be in a patient setting where there's a high unmet need.

首先，它將利用我們迄今為止在一個或多個適應症中使用 eganelisib 產生的一些令人鼓舞的數據。開發的重點將放在隨機對照環境中，以便我們可以非常清楚地顯示 Eganelisib 對標準治療方案的貢獻。第三，它將應用於存在大量未滿足需求的患者環境中。

So we've seen the benefit of eganelisib across a broad ray of solid tumors. It gives us many potential development path, as you mentioned, breast, urothelial, head and neck, ovarian melanoma. And so we're going to -- we're prioritizing that with a prospective partner and we look forward to announcing the details of the partnership and the first next trial and potential subsequent trials in the first quarter of 2023.

因此，我們已經看到了 Eganelisib 對多種實體瘤的益處。它為我們提供了許多潛在的發展途徑，正如您所提到的，乳癌、尿路上皮癌、頭頸部癌、卵巢黑色素瘤。因此，我們將優先考慮與潛在合作夥伴的合作，並期待在 2023 年第一季宣布合作細節以及首次試驗和潛在的後續試驗。

And just a kind of related follow-up. In the discussions and your own with KOLs and also coming away from the SITC conference over the weekend, any thoughts on what a registration study could look like in the context of PD-L1 status positive or negative?

這只是一種相關的後續行動。在與 KOL 的討論中，以及在周末參加 SITC 會議期間，對於在 PD-L1 狀態為陽性或陰性的背景下註冊研究會是什麼樣子，您有什麼看法？

And if there's an opportunity to lump them together also as a kind of a novel trial design. Could you comment on that? Would be helpful.

如果有機會將它們整合在一起，也是一種新穎的試驗設計。您能對此發表評論嗎？將會很有幫助。

Sure. I'll turn it over to Rob and just highlight that we have seen benefit with eganelisib in patients across multiple different tumor types, regardless of PD-L1 status. Of course, a registrational trial will depend on what is the approved standard of care in those different patient populations?

當然。我將把這個任務交給 Rob，並強調我們已經看到 Eganelisib 對多種不同腫瘤類型患者都有益處，無論 PD-L1 狀態如何。當然，註冊試驗將取決於不同患者群體所批准的護理標準是什麼？

And maybe, Rob, you can elaborate further.

羅布，也許你可以進一步詳細說明。

Sure. And also, I mean, regarding the TNBC question specifically, it's true, we are seeing pretty consistent 1-year PFS rates across B1 negative and positive tumors, which certainly is very encouraging. They're -- certainly, in thinking about pass for TNBC. One could be going for both patient populations, although now that there's a different standard of care for those two populations, it does make it a complex and probably large trial because of the two different control arms, the PD-L1 negative is certainly a great story. Though checkpoint inhibitors haven't been successful there.

當然。而且，我的意思是，具體到 TNBC 問題，確實，我們看到 B1 陰性和陽性腫瘤的 1 年 PFS 率相當一致，這當然非常令人鼓舞。他們——當然，正在考慮透過 TNBC。可以同時針對這兩類患者群體進行研究，儘管現在針對這兩類群體的治療標準不同，但由於存在兩個不同的對照組，這確實使試驗變得複雜且可能規模較大，但 PD-L1 陰性無疑是一個很棒的結果。儘管檢查點抑制劑在那裡尚未成功。

So certainly, you could argue that the great unmet need is in that PD-L1 negative group. So that's certainly also a very attractive path. And as Adelene mentioned, we believe the TNBC data kind of adds to totality of the data. So I think which way you decide to go, which tumor, which indication within a tumor, I think will be very much influenced by who our partner is and their preferences as well.

因此，您當然可以爭辯說，最大的未滿足需求存在於 PD-L1 陰性群體中。所以這當然也是一條非常有吸引力的路。正如 Adelene 所提到的，我們相信 TNBC 數據可以增加數據總量。因此，我認為，您決定採取哪種方式、治療哪種腫瘤、治療哪種腫瘤適應症，都將在很大程度上受到我們的伴侶及其偏好的影響。

And I'm showing no further questions at this time. And I'd like to turn the conference back over to Adelene for any further remarks.

我現在沒有其他問題了。我想將會議交還給阿德琳，請她發表進一步的評論。

Thank you, Michelle, and thank you all for joining us today. We are really enthusiastic about the data that we have generated and the progress of advancing eganelisib for the potential treatment of patients with cancers who are in dire need of improved therapy. So we look forward to updating you on our business development efforts and the focus of the next study for eganelisib within the coming months. Thank you for your continued support.

謝謝你，米歇爾，也謝謝大家今天的到來。我們對所獲得的數據以及推進 Eganelisib 用於治療急需改善治療的癌症患者的潛在治療的進展感到非常興奮。因此，我們期待在未來幾個月內向您通報我們的業務發展工作以及 eganelisib 的下一項研究的重點。感謝您一直以來的支持。

Thank you. This does conclude today's conference. You may all disconnect. Everyone, have a great day.

謝謝。今天的會議到此結束。你們都可以斷開連線。祝大家有個愉快的一天。