Zymeworks Inc (ZYME) 2023 Q1 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to Zymeworks First Quarter 2023 Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jack Spinks, Director of Investor Relations. Please go ahead.

    美好的一天,謝謝你的支持。歡迎參加 Zymeworks 2023 年第一季度業績電話會議。 (操作員說明)請注意,今天的會議正在錄製中。我現在想把會議交給今天的演講者,投資者關係總監傑克·斯平克斯 (Jack Spinks)。請繼續。

  • Jack W. Spinks - Associate Director of IR

    Jack W. Spinks - Associate Director of IR

  • Good afternoon, and welcome, everyone. My name is Jack Spinks, Head of Investor Relations here at Zymeworks. Today, we will discuss our first quarter financial results as well as provide an update to our ongoing business.

    下午好,歡迎大家。我叫 Jack Spinks,是 Zymeworks 的投資者關係主管。今天,我們將討論我們第一季度的財務業績,並提供我們正在進行的業務的最新情況。

  • Before we begin, I'd like to remind you that we will be making a number of forward-looking statements during this call, including, without limitation, those forward-looking statements identified in our presentation slides and the accompanying oral commentary. Forward-looking statements are based upon our current expectations and various assumptions and are subject to the usual risks and uncertainties associated with companies in our industry and at our stage of development. For a discussion of these risks and uncertainties, we refer you to our latest SEC filings as found on our website and as filed with the SEC. Later in this call, Chris Astle, our Senior Vice President and Chief Financial Officer, will be discussing our financial results, including certain non-GAAP measures. Description of our non-GAAP measures and a reconciliation to the most directly comparable financial measures as determined in accordance with GAAP are described in detail in our press release, which is available on our website at www.zymeworks.com under the Investor Relations tab.

    在我們開始之前,我想提醒您,我們將在本次電話會議期間做出一些前瞻性陳述,包括但不限於我們的演示幻燈片和隨附的口頭評論中確定的那些前瞻性陳述。前瞻性陳述基於我們目前的預期和各種假設,並受到與我們行業和我們發展階段的公司相關的常見風險和不確定性的影響。有關這些風險和不確定性的討論,我們建議您參閱我們網站上的最新文件以及向美國證券交易委員會提交的文件。在本次電話會議的後期,我們的高級副總裁兼首席財務官 Chris Astle 將討論我們的財務業績,包括某些非 GAAP 指標。我們的新聞稿中詳細描述了我們的非 GAAP 措施以及與根據 GAAP 確定的最直接可比財務措施的調節,該新聞稿可在我們網站 www.zymeworks.com 的“投資者關係”選項卡下獲取。

  • As a reminder, the audio and slides from this call will also be available on the Zymeworks website later today. Now I will turn the call over to Chris, our Senior Vice President and CFO. Chris?

    提醒一下,此次通話的音頻和幻燈片也將於今天晚些時候在 Zymeworks 網站上提供。現在我將把電話轉給我們的高級副總裁兼首席財務官克里斯。克里斯?

  • Christopher Astle - Senior VP & CFO

    Christopher Astle - Senior VP & CFO

  • Thanks, Jack, and thank you, everyone, for joining us today for our first quarter 2023 earnings call. As a reminder, I'd like to note that while I'll be presenting the prepared remarks and participating in Q&A today, Kenneth Galbraith, our Chair and CEO; Neil Klompas, our President and COO; and Paul Moore, our CFO, will also be available for Q&A following this portion of the call. With that, I'd like to begin today's call with an overview of our financial results, followed by a few recent developments and noteworthy updates across our business, before we open the lines for Q&A.

    謝謝杰克,也謝謝大家今天加入我們的 2023 年第一季度財報電話會議。提醒一下,我想指出,雖然我今天將發表準備好的發言並參與問答,但我們的主席兼首席執行官肯尼斯·加爾布雷思 (Kenneth Galbraith);我們的總裁兼首席運營官 Neil Klompas;我們的首席財務官 Paul Moore 也將在電話會議的這一部分之後進行問答。有了這個,我想在今天的電話會議開始前先概述一下我們的財務業績,然後是我們業務的一些近期發展和值得注意的更新,然後再開始問答。

  • This afternoon, Zymeworks reported financial results for the first quarter ended March 31, 2023. Zymeworks' net loss for the quarter ended March 31, 2023, was $24.4 million or $0.37 per diluted share compared to a net loss of $72.6 million for the quarter ended March 31, 2022. This decrease in net loss of approximately 66% year-over-year was driven largely by revenue from the reimbursable amounts received due to our collaboration agreement with Jazz and a decrease in R&D expenses.

    今天下午,Zymeworks 公佈了截至 2023 年 3 月 31 日的第一季度財務業績。Zymeworks 截至 2023 年 3 月 31 日的季度淨虧損為 2440 萬美元或攤薄後每股 0.37 美元,而截至該季度的淨虧損為 7260 萬美元2022 年 3 月 31 日。淨虧損同比減少約 66%,這主要是由於我們與 Jazz 的合作協議所收到的可償還款項的收入以及研發費用的減少。

  • As reported, our revenue for the first quarter of 2023 was $35.6 million compared to $1.9 million for the same period in 2022. The increase in revenues were largely due to reimbursable amounts received for zanidatamab's clinical development and manufacturing pursuant to our collaboration and licensing agreement with Jazz and research support and other payments from partners.

    據報導,我們 2023 年第一季度的收入為 3560 萬美元,而 2022 年同期為 190 萬美元。收入的增長主要是由於根據我們與爵士樂和研究支持以及來自合作夥伴的其他付款。

  • Research and development expenses for the quarter ended March 31, 2023, decreased by $16.6 million to $45.9 million as compared to $62.5 million for the quarter ended March 31, 2022. This decrease of 27% from the prior year related primarily to lower CRO and manufacturing expenses related to zanidatamab development and lower headcount-related expenses due to a decrease in headcount as compared to the same period in 2022. These were offset partially by an increase in clinical investigator costs for zanidatamab, and an increase in preclinical expenses for the continued development of our preclinical pipeline programs.

    截至 2023 年 3 月 31 日止季度的研發費用減少 1660 萬美元至 4590 萬美元,而截至 2022 年 3 月 31 日止季度的研發費用為 6250 萬美元。較上年同期減少 27%,主要與 CRO 和製造的降低有關由於與 2022 年同期相比人數減少,與 zanidatamab 開發相關的費用和與員工人數相關的費用減少。這些被 zanidatamab 的臨床研究人員成本增加以及持續開發的臨床前費用增加部分抵消我們的臨床前管道計劃。

  • As a reminder to those listening today, as announced on April 26, Zymeworks and Jazz entered into a transaction which, when closed, will transfer certain assets, contracts, and employees associated with the development of zanidatamab from Zymeworks to Jazz. This transaction was contemplated in order to simplify, focus and potentially expedite the clinical development and commercialization of zanidatamab.

    提醒今天的聽眾,正如 4 月 26 日宣布的那樣,Zymeworks 和 Jazz 達成了一項交易,交易完成後,將把與 zanidatamab 開發相關的某些資產、合同和員工從 Zymeworks 轉移到 Jazz。考慮進行此項交易是為了簡化、集中並可能加快 zanidatamab 的臨床開發和商業化。

  • The financial terms, as previously disclosed under the original licensing and collaboration agreement remain unchanged. Zymeworks will continue to be eligible for reimbursement of certain costs of activities where we maintain responsibility and Zymeworks is also eligible for reimbursement of certain prepayments to third parties for services or other expenses under contracts to be transferred to Jazz pursuant to the agreement.

    先前根據原始許可和合作協議披露的財務條款保持不變。 Zymeworks 將繼續有資格獲得我們承擔責任的活動的某些費用的報銷,並且 Zymeworks 也有資格獲得根據協議向第三方支付的服務或其他合同項下費用的某些預付款的報銷,這些費用將根據協議轉移給 Jazz。

  • In connection with our entry into these agreements, we anticipate our future research and development expenses and corresponding reimbursement revenue relating to zanidatamab under the license agreement with Jazz to decrease significantly. This reflects the transfer of responsibility as contemplated under the agreement, where Jazz will directly bear the ongoing zanidatamab-related costs incurred following the closing as opposed to the previously contemplated reimbursement mechanism.

    關於我們簽訂這些協議,我們預計我們未來的研發費用和與 Jazz 的許可協議下與 zanidatamab 相關的相應報銷收入將大幅減少。這反映了協議中預期的責任轉移,Jazz 將直接承擔關閉後發生的與 zanidatamab 相關的持續費用,而不是之前設想的報銷機制。

  • In connection with our amended agreement with Jazz, certain costs that we expect to incur will not be recovered by us, and the reimbursements to us from Jazz for the first quarter 2023 expenses will be reduced by the final agreed costs in connection with the transfer of the contracts and responsibilities to Jazz. We expect to begin recording the effect of these nonrecoverable costs in future periods. We expect our working capital requirements relating to our agreements with Jazz will be significantly reduced in Q2 due to the transfer of prepaid expenses to Jazz and the reduction in the receivables from Jazz under the reimbursement mechanism.

    關於我們與 Jazz 的修訂協議,我們預計將產生的某些費用將不會由我們收回,並且 Jazz 對我們的 2023 年第一季度費用的報銷將減去與轉讓相關的最終商定費用爵士的合同和責任。我們希望在未來期間開始記錄這些不可收回成本的影響。由於預付費用轉移給 Jazz 以及償還機制下 Jazz 的應收賬款減少,我們預計我們與 Jazz 的協議相關的營運資金需求將在第二季度大幅減少。

  • For the quarter ended March 31, 2023, general and administrative expenses were $16.9 million compared to $12.1 million for the same period in 2022. Excluding the significant noncash recovery of GBP 5.1 million in stock-based compensation, but including the impacts of restructuring as recorded in the first quarter of 2022, our general and administrative expenses decreased by approximately $2 million year-over-year on a non-GAAP basis, in line with our expectations. Our cash resources consisting of cash, cash equivalents, and marketable securities were $412.4 million as of March 31, 2023. As of May 8, 2023, we had approximately 66.7 million fully diluted shares outstanding. With the continued focus on the balance sheet and the significant transformative impacts of the nondilutive inflows from our licensing and collaboration agreement, we continue to expect our cash resources to fund our planned operations for at least 2026 and potentially beyond.

    截至 2023 年 3 月 31 日的季度,一般和行政費用為 1690 萬美元,而 2022 年同期為 1210 萬美元。不包括基於股票的薪酬中 510 萬英鎊的重大非現金回收,但包括記錄的重組影響2022 年第一季度,按非美國通用會計準則計算,我們的一般和行政費用同比減少約 200 萬美元,符合我們的預期。截至 2023 年 3 月 31 日,我們的現金資源(包括現金、現金等價物和有價證券)為 4.124 億美元。截至 2023 年 5 月 8 日,我們擁有約 6670 萬股完全稀釋的流通股。隨著我們對資產負債表的持續關注以及我們的許可和合作協議的非稀釋性資金流入的重大變革性影響,我們繼續期望我們的現金資源能夠為我們至少 2026 年甚至可能更長的計劃運營提供資金。

  • In addition, we are reiterating our net cash operating burn guidance of between $90 million and $120 million for the full year 2023. Neither of these guidance figures have changed from previous expectations as a result of the transfer of the ZZ entity to Jazz and the amendment to the licensing and collaboration agreement with Jazz.

    此外,我們重申 2023 年全年的淨現金運營消耗指導值在 9000 萬至 1.2 億美元之間。由於 ZZ 實體向 Jazz 的轉移以及修正案,這些指導數字均未改變之前的預期與 Jazz 的許可和合作協議。

  • For additional details on our quarterly results and for a description of our non-GAAP financial measures and a reconciliation of GAAP to non-GAAP measures, I encourage you to review our earnings through their SEC filings as available on our website at www.zymeworks.com. Now I'd like to spend a few minutes talking about our early R&D portfolio, which we recently highlighted at AACR as well as some brief updates to our clinical program.

    有關我們季度業績的更多詳細信息以及我們的非 GAAP 財務措施的描述以及 GAAP 與非 GAAP 措施的調節,我鼓勵您通過我們網站 www.zymeworks 上提供的美國證券交易委員會備案文件來審查我們的收益。 com。現在我想花幾分鐘談談我們最近在 AACR 上強調的我們早期的研發組合,以及我們臨床項目的一些簡短更新。

  • Last year was an important year for our early R&D programs as we unveiled 4 new preclinical candidates and multiple platform technologies that enable us to continue developing Novel Therapeutics. This year, we have continued that momentum with a significant presence at AACR, where we presented 11 posters showcasing the focused development program we have in the antibody drug conduit or ADC, and multispecific antibody therapeutics, or MSAT space.

    去年對於我們的早期研發項目來說是重要的一年,因為我們推出了 4 個新的臨床前候選藥物和多個平台技術,使我們能夠繼續開發新療法。今年,我們在 AACR 上繼續保持這種勢頭,我們展示了 11 張海報,展示了我們在抗體藥物管道或 ADC 以及多特異性抗體療法或 MSAT 空間中的重點開發計劃。

  • While I will encourage you to listen to our AACR webcast that discusses these product candidates and technology platforms in detail, I would like to highlight that we expect to nominate this year an additional IND candidates slated for 2025 submission. We also continue to remain focused on utilizing partnerships as a means to both fund and expedite the development of additional programs while leveraging additional non-dilutive funding mechanisms. Our partnership strategy is purposeful. With the 5x5 strategy we laid out in October of last year, which outlines our plan to have 5 new INDs by 2027, and we believe we will have the opportunity and funding to bring 5 candidates to the clinic.

    雖然我鼓勵您收聽我們詳細討論這些產品候選者和技術平台的 AACR 網絡廣播,但我想強調的是,我們預計今年將提名另外 IND 候選者,計劃於 2025 年提交。我們還繼續專注於利用合作夥伴關係作為資助和加速其他項目開發的手段,同時利用其他非稀釋性融資機制。我們的伙伴關係戰略是有目的的。根據我們去年 10 月制定的 5x5 戰略,該戰略概述了我們到 2027 年擁有 5 個新 IND 的計劃,我們相信我們將有機會和資金將 5 個候選人帶到診所。

  • Our robust technology platforms and world-class early R&D team provide us with the tool to continue growing our pipeline of early-stage preclinical product candidates beyond just these 5 in-house programs. These potential preclinical product candidates represent both a potential source of nondilutive funding and also can act as a source of screening for opportunities that we believe will help create a portfolio of both in-house and partnered candidates. We anticipate that for the in-house candidate developed via our 5x5 strategy, we would progress candidates through Phase II clinical studies, where we would then pursue an ex-U.S. partnering strategy.

    我們強大的技術平台和世界一流的早期研發團隊為我們提供了工具,使我們能夠在這 5 個內部項目之外繼續發展我們的早期臨床前候選產品管道。這些潛在的臨床前產品候選者既代表了非稀釋性資金的潛在來源,也可以作為篩選機會的來源,我們認為這將有助於創建內部和合作候選者的投資組合。我們預計,對於通過我們的 5x5 戰略開發的內部候選人,我們將通過 II 期臨床研究推進候選人,然後我們將尋求前美國。合作戰略。

  • With that, I'll briefly touch on zanidatamab, our clinical candidate recently partnered with Jazz Pharmaceuticals in the fourth quarter of last year. As you may have seen, our partners, Jazz and BeiGene, recently announced 2 exciting upcoming presentations at ASCO in June of this year. The first I will speak to today represents the first zanidatamab abstract to receive an oral presentation at a major medical meeting, where we intend to discuss the full findings from our Phase II pivotal study of zanidatamab as monotherapy in previously treated HER2 amplified biliary tract cancer or BTC. Second-line BTC has no FDA-approved HER2-targeted treatment options, and our top-line data, which showed a confirmed ORR of 41.3% and a median duration of response of 12.9 months in previously treated patients with HER2 amplified and expressing disease as presented in December of 2022, would represent a potentially significant step forward in the treatment of patients with previously treated HER2 amplified BTC. We look forward to the presentation of the full data set by our partner, Jazz, in June at the 2023 ASCO Annual Meeting in Chicago.

    有了這個,我將簡要介紹 zanidatamab,我們的臨床候選人最近在去年第四季度與 Jazz Pharmaceuticals 合作。正如您可能已經看到的,我們的合作夥伴 Jazz 和 BeiGene 最近宣布將於今年 6 月在 ASCO 上進行 2 場激動人心的演講。我今天要發言的第一位代表第一個在一次重要醫學會議上接受口頭報告的 zanidatamab 摘要,我們打算在會上討論我們 zanidatamab 作為單一療法治療先前治療的 HER2 擴增性膽道癌的 II 期關鍵研究的全部結果,或比特幣。二線 BTC 沒有 FDA 批准的 HER2 靶向治療方案,我們的一線數據顯示,在先前治療過的 HER2 擴增和表達疾病患者中,確認的 ORR 為 41.3%,中位反應持續時間為 12.9 個月於 2022 年 12 月提出,將代表在治療先前接受過 HER2 擴增 BTC 的患者方面向前邁出了重要的一步。我們期待我們的合作夥伴 Jazz 於 6 月在芝加哥舉行的 2023 年 ASCO 年會上展示完整的數據集。

  • The second abstract accepted for a poster presentation at ASCO to be presented by our partner, BeiGene, will be an update to the previously presented results from the Phase Ib/II study of zanidatamab in combination with docetaxel as a first-line therapy for patients with advanced HER2-positive breast cancer. Presented at ASCO 2022, this study provided a promising ORR of 90% in the study population. The future potential milestone and royalty payments from our zanidatamab licensing and collaboration agreement with Jazz, which will remain unchanged following our entry into the amended collaboration agreement, and our similar agreement with BeiGene, are expected to continue to be a significant source of non-dilutive capital for Zymeworks as zanidatamab progresses towards potential approval, which would come with regulatory and commercial milestones.

    我們的合作夥伴百濟神州在 ASCO 上接受海報展示的第二份摘要將是對之前公佈的紮尼達單抗聯合多西紫杉醇一線治療 Ib/II 期研究結果的更新晚期 HER2 陽性乳腺癌。在 ASCO 2022 上發表的這項研究在研究人群中提供了 90% 的有希望的 ORR。我們與 Jazz 簽訂的 zanidatamab 許可和合作協議的未來潛在里程碑和特許權使用費(在我們簽訂經修訂的合作協議後將保持不變)以及我們與 BeiGene 的類似協議預計將繼續成為非稀釋性的重要來源隨著 zanidatamab 取得潛在批准的進展,Zymeworks 的資金將伴隨監管和商業里程碑。

  • Along with our global partner, Jazz, and Asia Pacific partner, BeiGene, we look forward to the continued global development of zanidatamab, where we believe zanidatamab has the potential to treat a broad range of HER2-expressing cancers, including the potential to address unmet need outside of our 2 pivotal studies in BTC and GEA. We continue to have an exciting calendar ahead of us over the coming 2 years. As I mentioned earlier, with the upcoming presentations at ASCO and additional potential publications over the coming months, our partners will continue to present zanidatamab data that we believe can help position it, if approved, as the HER2-targeted antibody of choice for patients with HER2-expressing cancers.

    我們與我們的全球合作夥伴 Jazz 和亞太合作夥伴 BeiGene 一起,期待 zanidatamab 在全球範圍內的持續發展,我們相信 zanidatamab 有潛力治療廣泛的 HER2 表達癌症,包括解決未得到滿足的癌症的潛力需要我們在 BTC 和 GEA 的 2 項關鍵研究之外。在接下來的 2 年裡,我們繼續有一個令人興奮的日曆。正如我之前提到的,隨著即將在 ASCO 上發表的演講以及未來幾個月可能發表的其他文章,我們的合作夥伴將繼續展示 zanidatamab 的數據,我們認為這些數據如果獲得批准,將有助於將其定位為 HER2 靶向抗體,用於 HER2 靶向抗體表達 HER2 的癌症。

  • Later this year, we also plan to present additional data from our weekly cohort of zanidatamab zovodotin orzanidom, our HER2-targeted ADC, and expect to launch our 2 Phase II studies in non-small cell lung cancer in combination with PD-1 and in breast cancer after progression on T-DXd and in patients with lower levels of HER2 expression. We continue to pursue a combination strategy and would expect to partner with this asset prior to any registrational studies. While we need to gather more clinical data in the target indications, we believe that zanidatamab has the potential to be a preferred HER2-targeted ADC after patients progress on T-DXd or where a combination approach with the use of an ADC may make sense. We look forward to the continued development of this asset and reporting on the continued progress.

    今年晚些時候,我們還計劃提供來自我們的 HER2 靶向 ADC zanidatamab zovodotin orzanidom 的每週隊列的更多數據,並期望啟動我們的 2 項非小細胞肺癌聯合 PD-1 和T-DXd 進展後的乳腺癌和 HER2 表達水平較低的患者。我們繼續追求合併戰略,並希望在任何註冊研究之前與該資產合作。雖然我們需要收集更多關於目標適應症的臨床數據,但我們認為,在患者接受 T-DXd 治療取得進展後,或在使用 ADC 的組合方法可能有意義的情況下,zanidatamab 有可能成為首選的 HER2 靶向 ADC。我們期待這項資產的持續發展並報告持續的進展。

  • Moving on to our portfolio of preclinical assets. We expect to nominate the next preclinical product candidate this year with an IND filing planned for 2025. We also continue to expect 2024 IND filings for ZW191, or folate receptor alpha targeting top summarize ADC and for ZW171, or mesothelin-targeting 2+1 format T cell engaging bispecific antibody. Further, we anticipate nominating a 2026 IND candidate in calendar year 2024 as well. This timeline highlights our commitment to our 5x5 strategy, targeting 5 new INDs for 2027, which underpins the potential future development of our next-generation antibody-based therapeutics.

    繼續我們的臨床前資產組合。我們預計今年將提名下一個臨床前候選產品,併計劃在 2025 年提交 IND 申請。我們還繼續期待 2024 年提交 ZW191 的 IND 申請,或針對葉酸受體 alpha 的頂級總結 ADC 和 ZW171,或間皮素靶向 2+1 格式T 細胞接合雙特異性抗體。此外,我們預計還將在 2024 日曆年提名 2026 IND 候選人。該時間表突出了我們對 5x5 戰略的承諾,目標是在 2027 年獲得 5 個新的 IND,這為我們下一代基於抗體的療法的潛在未來發展奠定了基礎。

  • On the partnering front, we expect to continue pursuing preclinical partnerships to progress our preclinical development programs. This includes our expectation this year of partnering some of our early-stage assets as we continue progressing our ADC and MSAP portfolio in the coming years. As we leverage our focused R&D engine, we intend to continue our work to generate candidates where our partner may be the ideal choice to move them forward. For these assets, we will continue to seek attractive economics with upfront payments that help fund the development of our in-house candidates. With that, I'd like to thank everyone for listening to our prepared remarks, and I'll turn the call over to the operator to begin the question-and-answer session. Operator?

    在合作方面,我們希望繼續尋求臨床前合作夥伴關係,以推進我們的臨床前開發計劃。這包括我們今年期望在未來幾年繼續推進我們的 ADC 和 MSAP 產品組合時與我們的一些早期資產合作。當我們利用我們專注的研發引擎時,我們打算繼續我們的工作來產生候選人,我們的合作夥伴可能是推動他們前進的理想選擇。對於這些資產,我們將繼續通過預付款尋求有吸引力的經濟效益,以幫助資助我們內部候選人的發展。至此,我要感謝大家聽取我們準備好的發言,我將把電話轉給接線員,開始問答環節。操作員?

  • Operator

    Operator

  • (Operator Instructions) Our first question is from Stephen Willey with Stifel.

    (操作員說明)我們的第一個問題來自 Stifel 的 Stephen Willey。

  • Stephen Douglas Willey - Director

    Stephen Douglas Willey - Director

  • So I fully understand the Jazz amendment. I guess if I look at revenue this quarter, I think about, I don't know, about $34 million of that was either resource support payments or drug supply payments from Jazz. And I think about 80% of R&D or any related clinical development costs. So should we just assume then that once the amendment closes at some point in 2Q that those 2 things will no longer offset each other in the P&L?

    所以我完全理解爵士修正案。我想如果我看一下本季度的收入,我想,我不知道,其中大約 3400 萬美元來自 Jazz 的資源支持付款或藥品供應付款。我認為大約 80% 的研發或任何相關的臨床開發成本。那麼我們是否應該假設一旦修正案在第二季度的某個時候結束,這兩件事將不再在損益表中相互抵消?

  • Kenneth H. Galbraith - CEO & Chairman of the Board

    Kenneth H. Galbraith - CEO & Chairman of the Board

  • Yes. I'll let Chris answer that. Go ahead, Chris.

    是的。我會讓克里斯回答這個問題。來吧,克里斯。

  • Christopher Astle - Senior VP & CFO

    Christopher Astle - Senior VP & CFO

  • Yes, thanks for the question. That's right. Post the closure of this transaction with Jazz, the revenues from Jazz from the expense reimbursement will go away, and also the direct expenses we're incurring and then being reimbursed from Jazz will also go away. It's just worth noting there will be a partial quarter in Q2 from the beginning of the quarter through to the close. So there will still be some revenue and expenses relating to that, but that will go away. And it's just worth noting that revenue is recognized within the quarter, but then the as the expenses on the P&L, but then we keep that as accounts receivable on the balance sheet until it's reimbursed the following quarter.

    是的,謝謝你的提問。這是正確的。在與 Jazz 的這筆交易結束後,Jazz 從費用報銷中獲得的收入將會消失,我們產生的直接費用也將消失,然後從 Jazz 報銷。值得注意的是,從本季度開始到結束,第二季度會有部分季度。因此,仍然會有一些與此相關的收入和支出,但那會消失。值得注意的是,收入是在本季度內確認的,然後作為損益表上的費用確認,然後我們將其作為資產負債表上的應收賬款保留,直到下個季度報銷。

  • Stephen Douglas Willey - Director

    Stephen Douglas Willey - Director

  • Okay. I got it. And then I know you've talked before about being able to potentially monetize some of the agreements from the portfolio that you have of legacy licensing agreements. And I guess how do you structurally go about this? I guess do you propose some kind of flat repurchasing cost to the original licensing party? Or do you try to price this like an option and sell to some third party? I would just be curious as to how you go about potentially realizing that strategy.

    好的。我得到了它。然後我知道你之前談到過能夠從你擁有的遺留許可協議組合中的一些協議中獲利。我想你在結構上是如何處理這個的?我想你會向原始許可方提出某種固定的回購成本嗎?還是您嘗試將其定價為期權並出售給某些第三方?我只是想知道您如何著手實現該戰略。

  • Kenneth H. Galbraith - CEO & Chairman of the Board

    Kenneth H. Galbraith - CEO & Chairman of the Board

  • That's a good question. And again, we did look at a proposal last year to monetize a portion of the future milestones and royalties, so all those legacy deals as a basket. So not entirely, but as a portion. And we did that to have an additional potential financing vehicle to the extent that we were later closing a partnership in collaboration with Jazz than we were. We didn't need to do that. So we didn't execute that proposal. It was obviously at a higher cost of capital than we were able to get from the Jazz collaboration, so there was no need to do it. I think this year, in 2023, we expect and hope that a number of those programs will progress. And once they do, we think that will throw off some additional milestone cash inflows to us, as well as progressing a number of those programs to make the future milestones and royalties more viable because they'll be closer in time.

    這是個好問題。再一次,我們去年確實研究了一項將未來里程碑和特許權使用費的一部分貨幣化的提議,因此所有這些遺留交易都是一攬子交易。所以不是全部,而是作為一部分。我們這樣做是為了擁有一個額外的潛在融資工具,以至於我們後來與 Jazz 合作結束了合作關係。我們不需要那樣做。所以我們沒有執行該提議。這顯然比我們從 Jazz 合作中獲得的資金成本要高,所以沒有必要這樣做。我認為今年,即 2023 年,我們期待並希望其中一些項目能夠取得進展。一旦他們這樣做了,我們認為這將給我們帶來一些額外的里程碑現金流入,並推進其中一些計劃以使未來的里程碑和特許權使用費更加可行,因為它們的時間會更近。

  • So it's something that, after this year, if we can progress that pipeline, we may look at a similar structure or something that's a little bit different, but it is an ability for us to tap into a financing source should we choose to. We just weigh the amount of capital we could get, the cost of capital, and what we would use those funds for right now. Obviously, with a cash runway that's at least until 2026, unlikely beyond. We don't see the need to draw an additional cost of capital right now, but it is always available to us.

    因此,在今年之後,如果我們能夠推進該管道,我們可能會考慮類似的結構或稍微不同的東西,但如果我們選擇的話,它是我們利用融資來源的能力。我們只是權衡我們可以獲得的資金量、資金成本以及我們現在將使用這些資金做什麼。顯然,現金跑道至少要到 2026 年,以後不太可能。我們認為現在沒有必要提取額外的資本成本,但我們始終可以使用它。

  • Operator

    Operator

  • Our next question comes from Charles Zhu with Guggenheim Partners.

    我們的下一個問題來自 Guggenheim Partners 的 Charles Zhu。

  • Yue-Wen Zhu - Associate

    Yue-Wen Zhu - Associate

  • Congrats on the progress. My first one is regarding Zane's clinical update in the second half. Any additional color around how we should be setting our expectations around that data set, particularly around the distribution of histologies? Will we, for example, have an additional line of sight for a single agent data in your priority Phase II indications such as non-small cell lung cancer or post-HER2 breast cancer? And on a similarly related note, it sounds like the data will be from weekly dose cohorts. How many read-throughs will these data have to your other schedules that you may be evaluating with Zane?

    祝賀進步。我的第一個是關於 Zane 在下半場的臨床更新。關於我們應該如何圍繞該數據集設定我們的期望,特別是關於組織學分佈的任何其他顏色?例如,在您的優先 II 期適應症(例如非小細胞肺癌或 HER2 後乳腺癌)中,我們是否會對單一藥物數據有額外的視線?在類似的相關說明中,聽起來數據將來自每週劑量組。這些數據對您可能正在與 Zane 評估的其他時間表有多少通讀?

  • Kenneth H. Galbraith - CEO & Chairman of the Board

    Kenneth H. Galbraith - CEO & Chairman of the Board

  • Yes. Thanks for the question. I mean, obviously, we have a tremendous amount of additional data that we've been able to accumulate since the cutoff for ESMO that was presented last year and the following patients longer. We've got the 2-week dosing cohort finished. And we've also enrolled additional patients on monotherapy at the 2.5 mg per kg, including more patients in non-small cell lung cancer and more patients who are posting in HER2 in breast cancer. We're still writing the abstract right down, Charles, so I can't say exactly what will be in it, but we're looking forward to provide as much context as we can for Zane.

    是的。謝謝你的問題。我的意思是,很明顯,自去年 ESMO 截止以及以下患者更長時間以來,我們已經能夠積累大量額外數據。我們已經完成了為期 2 週的給藥隊列。我們還招募了更多接受 2.5 mg/kg 單藥治療的患者,包括更多非小細胞肺癌患者和更多 HER2 乳腺癌患者。查爾斯,我們仍在寫摘要,所以我不能確切地說出其中的內容,但我們期待為贊恩提供盡可能多的背景信息。

  • And in addition, we'll be closing that monotherapy arm and focusing on the combo studies that the other cohorts in non-full lung cancer breast that we're looking forward to going ahead with. And we're continuing to do some preclinical work around combinations, not with just PD-1 but TKIs and other checkpoint inhibitor combinations beyond PD-1 because I think there is some interest in looking at what might be possible by looking at CTLA-4 and even LIV-3 and others. So there still is tremendous preclinical work going on this year. I'm just not sure what will be in the abstract that we submit at first, but I don't expect it to get our last disclosure on zanidatamab.

    此外,我們將關閉單一治療組,並專注於我們期待繼續進行的非全肺癌乳腺癌其他隊列的聯合研究。我們將繼續圍繞組合開展一些臨床前工作,不僅是 PD-1,還有 TKI 和 PD-1 以外的其他檢查點抑製劑組合,因為我認為人們有興趣通過觀察 CTLA-4 來了解可能發生的事情甚至 LIV-3 和其他。因此,今年仍有大量臨床前工作正在進行。我只是不確定我們首先提交的摘要中會包含什麼,但我不希望它在 zanidatamab 上得到我們的最後披露。

  • Yue-Wen Zhu - Associate

    Yue-Wen Zhu - Associate

  • Got it. Sounds great. Maybe one follow-up regarding some of those combinations, especially with respect to combining Zans with PD-1, maybe something a bit more forward-looking, how are you thinking about enrollment criteria by PD-L1 and/or HER2 status? Would patients need be positive to presume for both? And do you also intend on stratifying by the level of positivity?

    知道了。聽起來不錯。也許關於其中一些組合的後續行動,特別是關於 Zans 與 PD-1 的組合,也許更具前瞻性,您如何考慮 PD-L1 和/或 HER2 狀態的入組標準?患者是否需要對兩者都是積極的假設?你是否也打算按積極程度進行分層?

  • Kenneth H. Galbraith - CEO & Chairman of the Board

    Kenneth H. Galbraith - CEO & Chairman of the Board

  • I mean those are great questions. You'll see once the protocols are on clin trials, you're able to get some more information around that. Obviously, there's still a tremendous interest, as you can see from recent dealmaking in other options in the HER2 ADC space beyond DXd and T-DM1, and we've been pretty clear our strategy with zanidatamab has been to try to be the HER2 ADC of choice post-DXd and try to give physicians a different mechanism on the antibody because it is the biparatopic any backbone.

    我的意思是這些都是很好的問題。一旦協議在臨床試驗中,您就會看到,您將能夠獲得更多相關信息。顯然,仍然存在巨大的興趣,正如您從 DXd 和 T-DM1 以外的 HER2 ADC 領域的其他選項最近的交易中看到的那樣,我們已經非常清楚我們與 zanidatamab 的戰略一直是試圖成為 HER2 ADC DXd 後的選擇,並嘗試為醫生提供抗體的不同機制,因為它是雙互補位任何主鏈。

  • We've tried to give KOLs a different payload, which is something that they've been requesting. And we'd like to give them the optionality of using zanidatamab in combination with other agents that are standard of care in indications where it's applicable. And that's how we arrived at right now the post-DXd space is defined in breast cancer and non-sale lung cancer, and that's why we've let ourselves look at studying at least 2 cohorts in non-small cell lung cancer, at least 2 cohorts in breast cancer to get some clinical data to support what we think KOLs are asking for as another agent of choice in the HER2 ADC space. And so I think once you see the protocols on controls.cov, then you'll have a lot more information about the nature and the structure of those studies.

    我們嘗試為 KOL 提供不同的有效負載,這是他們一直要求的。我們希望他們可以選擇將 zanidatamab 與其他適用的適應症標準護理藥物結合使用。這就是我們現在如何得出 DXd 後空間定義為乳腺癌和非銷售性肺癌的原因,這就是為什麼我們讓自己研究至少 2 個非小細胞肺癌隊列,至少2 個乳腺癌隊列以獲得一些臨床數據來支持我們認為 KOL 要求作為 HER2 ADC 空間中的另一種選擇代理的內容。因此,我認為一旦您看到 controls.cov 上的協議,您就會獲得更多關於這些研究的性質和結構的信息。

  • Operator

    Operator

  • Our next question comes from Derek Archila with Wells Fargo.

    我們的下一個問題來自富國銀行的 Derek Archila。

  • Derek Christian Archila - Senior Equity Analyst

    Derek Christian Archila - Senior Equity Analyst

  • Congrats on the progress. Just one question. Just wanted to see if you have any thoughts or see any key learnings on mirvetuximab's recent MIRASOL data, how that might inform ZW191's future development, either in ovarian or other potential tumor types.

    祝賀進步。只有一個問題。只是想看看您是否有任何想法或看到關於 mirvetuximab 最近的 MIRASOL 數據的任何關鍵知識,這可能如何為 ZW191 在卵巢或其他潛在腫瘤類型中的未來發展提供信息。

  • Kenneth H. Galbraith - CEO & Chairman of the Board

    Kenneth H. Galbraith - CEO & Chairman of the Board

  • No, great question. And I guess from our perspective, being in the biotech community, we always celebrate advances through innovation. And obviously, mirvetuximab is a step forward for a patient population who definitely needs a better standard of care. So we're really excited for patients with the data we saw at MIRASOL. And we're excited for the folks at MIRASOL who really stuck with us for probably 5 or more difficult years in trying to bring this therapy to market.

    不,很好的問題。我想從我們的角度來看,在生物技術界,我們總是通過創新來慶祝進步。顯然,mirvetuximab 對於絕對需要更好護理標準的患者群體來說是向前邁出的一步。因此,我們對在 MIRASOL 看到的數據的患者感到非常興奮。我們為 MIRASOL 的人們感到興奮,他們真正堅持我們可能 5 年或更艱難,試圖將這種療法推向市場。

  • So we feel happy for them. They've been dedicated with their desire to continue to move this forward. But a number of years ago, it may not have been the thing to look at doing. So that's great from that perspective. But also in the biotech community, we also then try and do better than our peers, and that's what our goal is right now. So I think from our perspective, there's a lot to learn from at least the initial patient population that's treatable with MIR. I think, looking at the low-grade ocatoxicities and how that's been perceived by regulators and also KOLs is kind of interesting for us, at least from zanidatamab perspective.

    所以我們為他們感到高興。他們一直致力於繼續推動這一進程。但幾年前,這可能不是值得考慮的事情。所以從這個角度來看這很棒。但在生物技術領域,我們也會嘗試比同行做得更好,這就是我們現在的目標。所以我認為從我們的角度來看,至少可以從 MIR 治療的初始患者群體中學到很多東西。我認為,至少從 zanidatamab 的角度來看,研究低級別的毒性以及監管機構和 KOL 對此的看法對我們來說有點有趣。

  • I think going beyond that and looking at our own folate receptor alpha program, we obviously have a very different strategy than MIR or the backup tumor, which is being developed, or some of the other agents, and that we're hoping to pursue the fuller receptor alpha a target regardless of tumor type and regardless of expression levels in patients, which we think is really the next step beyond where MRV has taken us. So we're looking at a pretty broad patient population and seeing if we can find a particular type of ADC that we designed specifically with a broad patient population in mind, regardless of tumor type and regardless of expression levels, looking to see if we can find efficacy with it. That was the nature of our engineering for our ADC, and we're looking forward to putting that in the clinic next year and seeing if we can prove that out with clinical studies and prove out what we hope we designed from a protein engineering standpoint. So I think we want to go well beyond MIRV and others in the folate receptor alpha-targeted therapy space.

    我認為超越這一點,看看我們自己的葉酸受體 alpha 計劃,我們顯然有一個非常不同的策略,而不是 MIR 或正在開發的備用腫瘤,或其他一些代理,我們希望追求fuller receptor alpha 是一個目標,無論腫瘤類型如何,也無論患者的表達水平如何,我們認為這確實是超越 MRV 的下一步。所以我們正在研究相當廣泛的患者群體,看看我們是否可以找到一種特定類型的 ADC,我們專門為廣泛的患者群體設計的,無論腫瘤類型和表達水平如何,看看我們是否可以找到它的功效。這就是我們 ADC 工程的本質,我們期待明年將其投入臨床,看看我們是否可以通過臨床研究證明這一點,並證明我們希望從蛋白質工程的角度設計的東西。因此,我認為我們希望在葉酸受體 α 靶向治療領域超越 MIRV 和其他公司。

  • And just to add that, sorry, and from our perspective, what we keep hearing from KOLs is that a significant interest, at least in the ovarian cancer space and some of beyond. So we're really excited about our proprietary payload that we're testing on that ADC as well as the breadth of the population that we might be able to provide a benefit for.

    只是補充一點,抱歉,從我們的角度來看,我們一直從 KOL 那裡聽到的是一種重要的興趣,至少在卵巢癌領域和其他領域。因此,我們對我們正在該 ADC 上測試的專有有效載荷以及我們可能能夠為之提供利益的人群的廣度感到非常興奮。

  • Operator

    Operator

  • Our next question comes from Brian Cheng with JPMorgan. Ken.

    我們的下一個問題來自摩根大通的 Brian Cheng。肯。

  • Lut Ming Cheng - Research Analyst

    Lut Ming Cheng - Research Analyst

  • So maybe just one quick question on BTC. Any updates on where you are in terms of the preparation for filing for BTC? And to the extent that you can, can you just give us some guidance on what could be the next update from our side that we could hear about the next potential steps in your BTC filing?

    所以也許只是一個關於 BTC 的快速問題。您在準備提交 BTC 方面的進展情況有何更新?在您可以的範圍內,您能否就我們方面的下一次更新提供一些指導,以便我們可以聽到您的 BTC 文件中的下一個潛在步驟?

  • Kenneth H. Galbraith - CEO & Chairman of the Board

    Kenneth H. Galbraith - CEO & Chairman of the Board

  • No. Great question. And obviously, we've been working very carefully with both Jazz and Beijing since our top-line data was announced in December last year because it was quite exciting data and really what we think might be transformative to the HER2 targeted therapy space in BTC. So we've been working obviously with Jazz and Beijing and discussing with regulators the pathway, both in the U.S. and in potential markets outside the U.S. where we may be able to get an approval with this data set. We haven't given guidance yet on timing of the first filings. We will leave that to Jazz and Beijing to discuss their filing strategies and timelines in their own jurisdictions.

    不,很好的問題。顯然,自去年 12 月我們的頂級數據公佈以來,我們一直在與 Jazz 和北京非常謹慎地合作,因為這是非常令人興奮的數據,而且我們認為這確實可能對 BTC 的 HER2 靶向治療領域產生變革。因此,我們顯然一直在與 Jazz 和北京合作,並與監管機構討論途徑,無論是在美國還是在美國以外的潛在市場,我們都可以通過該數據集獲得批准。我們尚未就首次提交的時間提供指導。我們將留給 Jazz 和北京討論他們在各自司法管轄區的申請策略和時間表。

  • Obviously, we've been working on supporting their potential regulatory filings, especially on the CMC module. So our work in FMC is complete, and we will ensure that that's not a rate-limiting factor to filing and we'll ensure that we're preapproval inspection ready, both in the U.S. and in foreign markets when necessary. So I think we're ahead of the curve in that perspective, which is our main role right now with both Jazz and Beijing. And obviously, what's coming up is that ASCO, we have an oral presentation with Dr. Pant, and we're really looking forward to sharing the full data set beyond the top-line data on zanidatamab's use as monotherapy in this patient population. We think it's potentially clinically meaningful improvement for this patient population, which does not currently have an approved therapy, and we're looking forward to sharing that information with KOLs and we'll continue to share that information with the regulators.

    顯然,我們一直在努力支持他們潛在的監管備案,尤其是在 CMC 模塊上。因此,我們在 FMC 的工作已經完成,我們將確保這不是申請的限速因素,我們將確保我們在必要時在美國和國外市場準備好批准前檢查。所以我認為我們在這個角度上處於領先地位,這是我們目前在爵士隊和北京隊中的主要角色。顯然,即將到來的是 ASCO,我們與 Pant 博士進行了口頭報告,我們真的很期待分享完整的數據集,而不是關於 zanidatamab 在該患者群體中用作單一療法的頂級數據。我們認為這對目前尚未獲得批准療法的患者群體來說可能具有臨床意義的改善,我們期待與 KOL 分享該信息,我們將繼續與監管機構分享該信息。

  • And so I think we'll leave the guidance on specific filing dates, but we're pretty excited. We also continue to enroll our Phase II BTC study with first-line patients using zanidatamab in combination with GemCis, and that continues to recruit. And we're hoping that will inform the potential for zanidatamab in combination with GemCis in an earlier patient population and I think as we've seen data come along from the use of PD-1 and GemCis in this patient population, there's certainly a thought that a HER2-targeted therapy for a patient with HER2 implication is really the way to address the poor prognosis that goes along with that genetic actionable biomarker. So that continues to go on. We haven't given guidance about when that might be fully recruited or what would make you beyond that, and we'll let Beijing and Jazz provide that guidance as well.

    因此,我認為我們將保留關於具體申請日期的指南,但我們非常興奮。我們還繼續將 zanidatamab 與 GemCis 結合使用的一線患者納入我們的 II 期 BTC 研究,並繼續招募。我們希望這將告知 zanidatamab 與 GemCis 在早期患者群體中聯合應用的潛力,我認為正如我們已經看到在該患者群體中使用 PD-1 和 GemCis 的數據一樣,肯定有一個想法對具有 HER2 影響的患者進行 HER2 靶向治療確實是解決伴隨該遺傳可操作生物標誌物而來的不良預後的方法。所以這種情況會繼續下去。我們還沒有給出關於什麼時候可以完全招募或者什麼會讓你超越這一點的指導,我們也會讓北京和爵士隊提供指導。

  • Operator

    Operator

  • Our next question comes from Yigal Nochomovitz with Citi.

    我們的下一個問題來自花旗的 Yigal Nochomovitz。

  • Unidentified Analyst

    Unidentified Analyst

  • This is [Carly on Barry] Yigal. I'm following up on a prior question related to the Phase II strategy for Zane. I guess for lung, you've disclosed the PD-1 combo, but for breast, can you just talk about what combination partners you're considering if you also plan to look at monotherapy in post and HER2 patients? And just any feedback you've gotten from KOLs on that? And then if you can also just clarify if you expect the Phase II to be randomized studies for a single arm, that would be great as well.

    我是 [Carly on Barry] Yigal。我正在跟進與 Zane II 階段戰略相關的先前問題。我想對於肺,你已經公開了 PD-1 組合,但對於乳房,如果你還計劃在 HER2 後和 HER2 患者中進行單藥治療,你能談談你正在考慮的聯合夥伴嗎?您從 KOL 那裡得到的任何反饋?然後,如果您還可以澄清您是否希望 II 期是針對單臂的隨機研究,那也很好。

  • Kenneth H. Galbraith - CEO & Chairman of the Board

    Kenneth H. Galbraith - CEO & Chairman of the Board

  • Yes. The second piece of that, you have to wait until you see the clinical protocols up on clintrials.gov. But obviously, we've been in discussions with KOLs on the breast cancer cohorts. We're really interested in studying patients in a post-DXd environment. And so after progression, and we're also studying patients in breast cancer who have lower levels of HER2 expression. And we've been discussing with KOLs, whether that should be done in a monotherapy setting to understand the benefit of zanidatamab or whether there are combination studies that we can look at. And obviously, we won't confirm that until you see the clinical protocols. I think in non-small cell lung cancer, it was easier with the prevalence of pembro being used as the standard of care. It was easier in the overexpressing population. And in the HER2-amplified population to look at that as a natural combination to evaluate.

    是的。第二部分,你必須等到你在 clintrials.gov 上看到臨床協議。但顯然,我們一直在與 KOL 就乳腺癌隊列進行討論。我們非常有興趣在後 DXd 環境中研究患者。因此,在進展之後,我們還在研究 HER2 表達水平較低的乳腺癌患者。我們一直在與 KOL 討論,是否應該在單一療法中進行以了解 zanidatamab 的益處,或者是否有我們可以研究的聯合研究。顯然,在您看到臨床方案之前,我們不會確認這一點。我認為在非小細胞肺癌中,pembro 的流行被用作護理標準更容易。在過度表達的人群中更容易。在 HER2 擴增的人群中,將其視為評估的自然組合。

  • Beyond that in both those settings, there are other combinations, which I don't think we'll be able to study within the current confines of our capital allocation for the Phase IIs. But we've looked at and we will continue to look at preclinically in combination with TKIs, which might be of interest, and also additional checkpoint inhibitor mechanisms beyond PD-1, which we think is something that might be interesting as well. I just don't think our capital allocation to Phase II allows us to do that initially. But it is something that we'll study preclinically and eventually a partnership might allow us to study some additional combinations beyond the ones that we're currently going to study in Phase II.

    除此之外,在這兩種情況下,還有其他組合,我認為我們無法在當前 II 期資本配置範圍內研究這些組合。但我們已經研究並將繼續研究臨床前與 TKI 的結合,這可能會引起人們的興趣,以及除 PD-1 之外的其他檢查點抑製劑機制,我們認為這也可能很有趣。我只是認為我們對第二階段的資本配置不允許我們一開始就這樣做。但這是我們將在臨床前研究的東西,最終合作夥伴關係可能使我們能夠研究一些額外的組合,而不是我們目前將在第二階段研究的組合。

  • Operator

    Operator

  • And we have our last question from Akash Tewari with Jefferies.

    我們有 Jefferies 的 Akash Tewari 提出的最後一個問題。

  • Unidentified Analyst

    Unidentified Analyst

  • This is Steve on for Kash. Just regarding ZW49. Can you comment on what ballpark you plan to spend in the program this year? And what do you think of the competitive landscape for HER2 ADC outside of HER2?

    這是卡什的史蒂夫。只是關於ZW49。你能評論一下你今年計劃在這個項目中花多少錢嗎?您如何看待 HER2 之外的 HER2 ADC 的競爭格局?

  • Kenneth H. Galbraith - CEO & Chairman of the Board

    Kenneth H. Galbraith - CEO & Chairman of the Board

  • Yes. On the first question, we won't talk about that ahead of time. But obviously, on a quarterly basis when we file our financial statements, including Q1, which you'll see, you'll see how spending is allocated between Zanezo and Zane and the early-stage pipeline. So I think as we go through the year on a quarterly basis, you'll be able to see how the actual spending has been made. So you'll answer that in a retrospective manner. I think in the HER2 space, I think we've seen some additional business development interest, and other folks too big had an investment. And I think that's because they're probably hearing the same message that we are from KOLs is that they're looking for additional options as ADC formats in the HER2-targeted therapy space. And I think that's pushing a lot of folks to look at how they would compete strategically in that segment.

    是的。關於第一個問題,我們先不談。但顯然,當我們按季度提交財務報表時,包括你會看到的第一季度,你會看到支出是如何在 Zanezo 和 Zane 以及早期管道之間分配的。所以我認為當我們按季度回顧這一年時,您將能夠看到實際支出是如何產生的。所以你會以回顧的方式回答這個問題。我認為在 HER2 領域,我認為我們已經看到了一些額外的業務發展興趣,而其他太大的人也進行了投資。我認為這是因為他們可能從 KOL 那裡聽到了與我們相同的信息,即他們正在 HER2 靶向治療領域尋找其他選項作為 ADC 格式。我認為這促使很多人研究他們將如何在該領域進行戰略競爭。

  • We've been very clear about our strategy of trying to find a way to fit into the post-DXd space. We think it's very attractive from an economic perspective. And we think it's an area that we can with Zanezo provide some optionality for physicians to follow T-DXd with an antibody that's not TRAS with a payload that's not DXd, with a mechanism that's quite different because of the biparatopic nature of binding with Zanezo and also the optionality of using it in combination with other standards of care because the tolerability profile is from what we've seen clinically the best of any (inaudible) study clinically to date and release data.

    我們一直非常清楚我們的戰略,即試圖找到一種適合後 DXd 空間的方法。我們認為從經濟角度來看它非常有吸引力。我們認為這是一個我們可以與 Zanezo 一起為醫生提供一些選擇的領域,讓他們使用一種不是 TRAS 的抗體和一種不是 DXd 的有效載荷來跟踪 T-DXd,由於與 Zanezo 結合的雙互補位性質和還可以選擇將它與其他護理標準結合使用,因為耐受性概況來自我們在臨床上看到的迄今為止臨床上最好的(聽不清)研究和發布數據。

  • And so we've been very clear about where we would like to compete in that space. And we've been clear about the Phase II studies that we've designed that we expect to initiate this year, we'll provide data to show that we can compete in that space. And then we hope that data is overwhelming enough to allow us to invest further and to find a partner in an ex-U.S. basis who wants to join us in that to find a regulatory pathway for Zanezo to be the next choice ADC in a DXd environment. So I think we're quite excited that there's room in that space to compete, provide physicians with something more than they can currently get from T-DXd andT-DM1. And then Zanezo might be well positioned in combination to play a major role in that. And that's why we're set to allocate some capital along with a substantial amount of capital in our 5 strategies in our early-stage portfolio.

    因此,我們一直非常清楚我們希望在該領域的哪些競爭領域。我們已經清楚我們設計的第二階段研究,我們希望在今年啟動,我們將提供數據來表明我們可以在該領域競爭。然後我們希望數據足夠強大,讓我們能夠進一步投資並在美國以外的地方找到合作夥伴。希望加入我們的基礎,為 Zanezo 找到監管途徑,使其成為 DXd 環境中的下一個選擇 ADC。所以我認為我們很高興在這個領域有競爭的空間,為醫生提供比他們目前從 T-DXd 和 T-DM1 獲得的更多的東西。然後 Zanezo 可能會很好地組合起來在其中發揮重要作用。這就是為什麼我們準備在我們早期投資組合的 5 種策略中分配一些資本和大量資本。

  • Operator

    Operator

  • And I'm showing no further questions at this time. I would like to turn it back over to Ken Galbraith for any closing remarks.

    我現在沒有進一步提問。我想將它轉回給 Ken Galbraith 以作任何結束語。

  • Kenneth H. Galbraith - CEO & Chairman of the Board

    Kenneth H. Galbraith - CEO & Chairman of the Board

  • Great. Thank you, operator. So thank you for attending our Q1 earnings and business update call. As you can hopefully tell, we're pretty excited about 2023 and the progress we expect to make in the entire pipeline. We're excited about where we are with zanidatamab, with our partners, Jazz and Beijing. We think we have a clear path for some additional Phase II clinical studies in Zanezo. I think our 2 next patients go to the clinic are on track in 2024 to be INDs in both the folate receptor alpha and mesothelin, 2-plus 1 T cell engager. We're thinking now about what's going to be next in the clinic beyond those 2 and hope to have some updates for you soon on that.

    偉大的。謝謝你,運營商。因此,感謝您參加我們的第一季度收益和業務更新電話會議。正如您所希望的那樣,我們對 2023 年以及我們期望在整個管道中取得的進展感到非常興奮。我們對我們與 zanidatamab 以及我們的合作夥伴 Jazz 和北京的進展感到興奮。我們認為我們有一條清晰的道路,可以在 Zanezo 進行一些額外的 II 期臨床研究。我認為我們下一位去診所的 2 名患者有望在 2024 年成為葉酸受體 α 和間皮素 2-plus 1 T 細胞接合劑的 IND。我們現在正在考慮除了這兩個之外診所接下來會發生什麼,並希望盡快為您提供一些更新。

  • And in addition, we're hopefully making some progress with some of the legacy licensing platform deals we have, which will provide some cash flows and also some additional value that we can potentially monetize in the future if we have some additional need for some capital. And so we're excited about that. The team is working very hard, and we look forward to presenting some additional progress for you. Next up at ASCO. We hope you have the ability to attend or listen to the oral presentation from Dr. Pant in the full BTC data as well as the update from Beijing on looking at the use of zanidatamab and docetaxel in first-line breast cancer patients, which we think is going to be really encouraging for future indications with zanidatamab. So thank you very much for your attention, and I look forward to updating you again over the course of the quarter and at the end of Q2 as well.

    此外,我們希望在我們擁有的一些傳統許可平台交易方面取得一些進展,這將提供一些現金流和一些額外的價值,如果我們有一些額外的資本需求,我們可以在未來將其貨幣化.所以我們對此感到興奮。團隊正在努力工作,我們期待為您展示一些額外的進展。接下來在 ASCO。我們希望您有能力參加或聆聽 Pant 博士在完整 BTC 數據中的口頭報告,以及來自北京的更新,了解我們認為在一線乳腺癌患者中使用扎尼達單抗和多西紫杉醇的情況對於 zanidatamab 的未來適應症,這將是非常令人鼓舞的。非常感謝您的關注,我期待在本季度和第二季度末再次向您更新。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating. You may now disconnect.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。