Y-mAbs Therapeutics Inc (YMAB) 2024 Q2 法說會逐字稿

Good morning, and welcome to Y-mAbs Therapeutics Inc.'s earnings conference call for the second quarter of 2024. (Operator Instructions)

早安，歡迎參加 Y-mAbs Therapeutics Inc. 2024 年第二季財報電話會議。（操作員說明）

As a reminder, today's conference will be recorded. I will now hand it over to Y-mAbs' Head of Investor Relations, Courtney Dugan. Please go ahead.

提醒一下，今天的會議將被錄製。我現在將其交給 Y-mAbs 投資者關係主管 Courtney Dugan。請繼續。

Thank you, operator, and good morning, everyone. Welcome to the Y-mAbs' second-quarter 2024 financial results conference call. We issued a press release with our results this morning before the market opened. The press release and accompanying slides are available on the Investor Relations section of our website. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995.

謝謝接線員，大家早安。歡迎參加 Y-mAbs 2024 年第二季財務業績電話會議。今天早上開市前，我們發布了一份新聞稿，公佈了我們的業績。新聞稿和隨附的幻燈片可在我們網站的投資者關係部分取得。讓我快速提醒您，以下討論包含某些被視為 1995 年《私人證券訴訟改革法案》所定義的前瞻性陳述的陳述。

Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans, expectations with respect to early trial data, current and future clinical and preclinical studies and our research and development programs, expectations related to the timing of the initiation and completion of regulatory submissions, regulatory marketing and reimbursement approvals, including statements with respect to future development of other development programs, potential for DANYELZA territory and label expansion, and potential of an advancement of SADA, collaborations or strategic partnerships, and the potential benefits thereof, expectations related to our anticipated cash runway and cash burn, and the sufficiency of our cash resources and assumptions related thereto, guidance and expectations for 2024 and beyond, and our financial performance, including our estimates regarding revenues, expenses, capital expenditure requirements and other statements that are not historical facts.

此類聲明包括但不限於有關我們的業務模式和開發、商業化和產品分銷計劃的聲明、對早期試驗數據的期望、當前和未來的臨床和臨床前研究以及我們的研發計劃、與啟動和完成監管提交、監管行銷和報銷批准的時間，包括有關其他開發計劃的未來發展、DANYELZA 領土和標籤擴張的潛力以及SADA 進步的潛力、合作或戰略夥伴關係的聲明，以及其潛在收益、與我們預期現金與跑道和現金消耗相關的預期、我們現金資源的充足性和與之相關的假設、2024 年及以後的指導和預期，以及我們的財務業績，包括我們對收入、費用、資本的估計支出要求和其他不屬於歷史事實的陳述。

Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors including those risk factors discussed in the company's previously filed annual report on Form 10-K for the year ended December 31, 2023, quarterly report on Form 10-Q for the quarter ended March 31, 2024, and the company's quarterly report on Form 10-Q for the quarter ended June 30, 2024, to be filed with the SEC today.

由於前瞻性陳述涉及風險和不確定性，它們並不是對未來業績的保證，並且由於多種因素（包括公司之前討論的風險因素），實際結果可能與這些前瞻性陳述明示或暗示的結果存在重大差異。 ，今天向SEC 提交。

I would now like to turn the call over to our President and Chief Executive Officer, Mike Rossi.

我現在想將電話轉給我們的總裁兼執行長 Mike Rossi。

Thank you, Courtney. Good morning, and thank you for joining us. I have with me today our Chief Commercial Officer, Sue Smith, our Chief Medical Officer, Dr. Vignesh Rajah; and our new Chief Financial Officer, Pete Pfreundschuh. This morning, I will begin by reviewing key financial and operational highlights for the second quarter of 2024, including DANYELZA's sales performance and the clinical progress of our radiotherapy clinical programs, utilizing our self-assembly, disassembly, pretargeted radioimmunotherapy or SADA-PRIT technology platform.

謝謝你，考特尼。早安，感謝您加入我們。今天與我在一起的還有我們的商務長 Sue Smith、我們的首席醫療官 Vignesh Rajah 博士；以及我們新任財務長 Pete Pfreundschuh。今天早上，我將首先回顧2024 年第二季度的主要財務和營運亮點，包括DANYELZA 的銷售業績和我們的放射治療臨床計畫的臨床進展，利用我們的自組裝、拆卸、預定位放射免疫療法或SADA -PRIT 技術平台。

Next, Sue will provide details around our global DANYELZA sales in the second quarter. Vignesh will then provide updates around our ongoing naxitamab ISS clinical trials.

接下來，Sue 將提供有關第二季度 DANYELZA 全球銷售的詳細資訊。然後，Vignesh 將提供有關我們正在進行的 naxitamab ISS 臨床試驗的最新資訊。

Pete will then review our second quarter of 2024 financial performance, our cash resources and provide an update to our full year 2024 guidance before we open the line for Q&A. Let's begin with key highlights for the second quarter of 2024, starting with DANYELZA.

然後，皮特將回顧我們 2024 年第二季度的財務業績、現金資源，並在我們開通問答熱線之前提供 2024 年全年指引的最新資訊。讓我們從 DANYELZA 開始，了解 2024 年第二季的主要亮點。

As many of you know, neuroblastoma is the most common cancer in infants and the third most common cancer in children. Our commercial drug, DANYELZA, is a leading anti-GD2 therapy in the US and remains critically important therapy for children with relapsed/refractory high-risk neuroblastoma.

眾所周知，神經母細胞瘤是嬰兒中最常見的癌症，也是兒童第三常見的癌症。我們的商業藥物 DANYELZA 是美國領先的抗 GD2 療法，對於患有復發/難治性高風險神經母細胞瘤的兒童仍然至關重要。

DANYELZA is humanized and is the only FDA-approved immunotherapy for high-risk neuroblastoma that is specifically designed for children who have an incomplete response to induction or relapsed therapy and also have disease in the bone and/or bone marrow.

DANYELZA 是人源化的，是 FDA 批准的唯一一種針對高風險神經母細胞瘤的免疫療法，專為對誘導或復發治療反應不完全且患有骨骼和/或骨髓疾病的兒童而設計。

Importantly, DANYELZA can be administered either outpatient or inpatient depending on the specific needs of the child and his or her family. In the second quarter of 2024, we achieved total DANYELZA net product revenue of $22.8 million, up 10% from the second quarter of 2023.

重要的是，DANYELZA 可以在門診或住院治療，這取決於孩子及其家人的特定需求。2024 年第二季度，我們實現 DANYELZA 產品淨收入總額為 2,280 萬美元，較 2023 年第二季成長 10%。

The increase was primarily driven by a boost in international orders from our partners WEP in Western Europe and Adium in Latin America, which includes the commercial launch in Brazil and Mexico. For the first 6 months of the year, we achieved total DANYELZA net product revenues of $42.2 million, up 3% from the same period in 2023.

這一增長主要是由於我們在西歐的合作夥伴 WEP 和拉丁美洲的 Adium 的國際訂單增加所致，其中包括在巴西和墨西哥的商業發布。今年前 6 個月，我們實現 DANYELZA 產品淨收入總額為 4,220 萬美元，比 2023 年同期成長 3%。

The increase was primarily driven by an increase in US revenues in the first half of 2024 compared to the year prior period. We are continuing to drive DANYELZA forward and are penetrating more centers. In the second quarter alone, DANYELZA has been added to two new hospital formularies.

這一增長主要是由於 2024 年上半年美國收入較上年同期增加。我們將繼續推動 DANYELZA 向前發展，並滲透到更多的中心。僅在第二季度，DANYELZA 就被添加到兩家新的醫院處方集中。

Although we saw increased market in clinical trial competition for patients in the US during the second quarter, we view this as a net positive for patients and families. As a company, we are driving investments around direct-to-parent educational efforts focused on DANYELZA differentiators in bone and bone marrow. The Y-mAbs team has deep knowledge of the market and is specifically dedicated to pediatric neuroblastoma. Ex-US, we saw a boost in orders in the second quarter of this year as compared to the first quarter of this year.

儘管我們在第二季度看到美國患者臨床試驗市場競爭加劇，但我們認為這對患者和家庭來說是一個淨積極的結果。作為一家公司，我們正在圍繞直接面向家長的教育工作推動投資，重點關注 DANYELZA 在骨骼和骨髓方面的差異化優勢。Y-mAbs 團隊對市場有深入的了解，專門致力於兒童神經母細胞瘤。除美國外，我們看到今年第二季的訂單較第一季增加。

Our partner, Adium executed the DANYELZA commercial launch in both Brazil and Mexico. We are very pleased with how these launches are progressing and look forward to providing further updates in future quarters. In Asia, our SciClone partner continues to expand the use of DANYELZA in China.

我們的合作夥伴 Adium 在巴西和墨西哥執行了 DANYELZA 的商業發布。我們對這些發布的進展感到非常滿意，並期待在未來幾季提供進一步的更新。在亞洲，我們的 SciClone 合作夥伴繼續擴大 DANYELZA 在中國的使用。

Additionally, we are thrilled to have received approval for DANYELZA in Hong Kong and look forward to working with our Eastern Asia partner SciClone in anticipation of the commercial launch of DANYELZA in Hong Kong. Our European named patient program with WEP clinical is also continuing to progress as we support the needs of children with high-risk relapsed or refractory neuroblastoma in Western Europe.

此外，我們很高興 DANYELZA 在香港獲得批准，並期待與我們的東亞合作夥伴 SciClone 合作，期待 DANYELZA 在香港的商業上市。我們的 WEP 臨床歐洲指定患者計劃也在不斷取得進展，因為我們支持西歐患有高風險復發或難治性神經母細胞瘤的兒童的需求。

In addition to our new approval in Hong Kong, we entered into a distribution agreement with TRPharm for patient named program distribution of DANYELZA in Turkey.

除了在香港獲得新的批准外，我們還與 TRPharm 簽訂了一份分銷協議，在土耳其以患者命名的項目分銷 DANYELZA。

We also plan to submit a BLA for DANYELZA in Argentina later this year. We remain confident in our US commercial strategy and trajectory and in the continued ex US expansion of DANYELZA. Vignesh will provide updates on our investigator-sponsored trials of naxitamab later during this call.

我們還計劃今年稍晚在阿根廷提交 DANYELZA 的 BLA。我們對我們的美國商業戰略和軌跡以及 DANYELZA 在美國以外的持續擴張仍然充滿信心。Vignesh 將在稍後的電話會議中提供我們研究者資助的 naxitamab 試驗的最新資訊。

Let me now shift to our clinical progress of our SADA-PRIT programs. We are currently in Part A of our GD2-SADA Phase I trial, evaluating the safety and tolerability of the SADA-PRIT in the treatment of GD2-positive solid tumors, including small cell lung cancer, sarcomas and malignant melanoma. As a reminder, this Phase I dose escalation single-arm multicenter safety study has three parts.

現在讓我談談 SADA-PRIT 計畫的臨床進展。我們目前正在進行 GD2-SADA I 期試驗的 A 部分，評估 SADA-PRIT 治療 GD2 陽性實體瘤（包括小細胞肺癌、肉瘤和惡性黑色素瘤）的安全性和耐受性。提醒一下，這項 I 期劑量遞增單臂多中心安全性研究分為三個部分。

Part A, which we are currently in is structured to demonstrate the safety profile of the protein, while it explores dose finding for the GD2-SADA molecule and testing of dose intervals of two to five days between the protein and the lutetium 177 DOTA payload. Part B determines the optimal dose of lutetium 177 DOTA and Part C evaluates the initial signs of efficacy using repeat dosing.

我們目前所處的 A 部分旨在證明該蛋白質的安全性，同時探索 GD2-SADA 分子的劑量尋找以及蛋白質與镥 177 DOTA 有效負載之間兩到五天的劑量間隔測試。B 部分確定镥 177 DOTA 的最佳劑量，C 部分使用重複給藥評估療效的初始跡象。

We are pleased with how the trial is progressing and advanced through Cohort 4. We are currently in Cohort 5. We have dosed a total of 17 patients to date in Part A of this trial. We currently have six sites open and plan to continue adding additional sites. We are encouraged by what we've seen so far.

我們對第 4 組試驗的進展和進展感到滿意。我們目前處於第 5 組。迄今為止，在本試驗的 A 部分中，我們已對總共 17 名患者進行了給藥。我們目前開放了六個站點，並計劃繼續添加更多站點。我們對迄今為止所看到的情況感到鼓舞。

To date, no patients in the trial have experienced any dose-limiting toxicities, and there have been no instances of treatment-related serious adverse events. Based on the spec CT scans and PK activity we have seen to date, we believe we have demonstrated proof of concept in humans that GD2-SADA can both find and bind to tumors.

迄今為止，試驗中沒有患者出現任何劑量限制性毒性，也沒有發生與治療相關的嚴重不良事件。根據我們迄今為止所看到的規格 CT 掃描和 PK 活性，我們相信我們已經在人類中證明了 GD2-SADA 既可以發現腫瘤又可以與腫瘤結合的概念證明。

It is important to note that these early data are not complete and not necessarily indicative of full results or ultimate success of the trials or the SADA development program. We expect to complete Part A of the Phase I study by the end of this year and look to present the full data set from Part A at a medical meeting in early 2025. In the data readout from Part A of the trial, our objective is to demonstrate the safety profile of the protein and determine the optimal timing to administer the radionuclide, all of which will inform Part B.

值得注意的是，這些早期數據並不完整，也不一定表示試驗或 SADA 開發計畫的全部結果或最終成功。我們預計在今年年底前完成 I 期研究的 A 部分，並希望在 2025 年初的醫學會議上展示 A 部分的完整數據集。在試驗 A 部分的數據讀出中，我們的目標是證明蛋白質的安全性並確定施用放射性核素的最佳時機，所有這些都將為 B 部分提供資訊。

In addition, we plan to show additional scanned images and PK data. Our second SADA-PRIT program is CD38-SADA, which we plan to first study in the treatment of non-hodgkin's lymphoma focusing on B and T cell lymphoma. This will be our first SADA program in circulating tumors.

此外，我們計劃展示額外的掃描影像和 PK 資料。我們的第二個 SADA-PRIT 計畫是 CD38-SADA，我們計劃首先研究該計畫用於治療非何杰金氏淋巴瘤，重點是 B 和 T 細胞淋巴瘤。這將是我們針對循環腫瘤的第一個 SADA 計畫。

Our plan Phase I follows a comparable design to our GD2-SADA Phase I trial, which you can see here. We have selected the first 6 sites and expect to dose the first patient in the second half of this year.

我們的計劃第一階段遵循與 GD2-SADA 第一階段試驗類似的設計，您可以在此處查看。我們已經選定了前 6 個地點，預計在今年下半年為第一位患者給藥。

We strongly believe SADA-PRIT has the potential to shift the radiotherapy treatment paradigm across a variety of cancers and potentially even in indications beyond oncology, all while avoiding many of the infrastructure, manufacturing and administration challenges that many other technologies are facing.

我們堅信 SADA-PRIT 有潛力改變多種癌症的放射治療模式，甚至可能改變腫瘤學以外的適應症，同時避免許多其他技術面臨的許多基礎設施、製造和管理挑戰。

We look forward to providing further updates on our SADA-PRIT programs going forward. Our team remains steadfast in our collective commitment to improve patient lives, and I'm very proud of the progress we continue to make to advance our novel therapies through clinical development.

我們期待提供有關 SADA-PRIT 計劃的進一步更新。我們的團隊仍然堅定地致力於改善患者生活的集體承諾，我對我們透過臨床開發推進新療法不斷取得的進展感到非常自豪。

I will now pass the call over to Sue Smith to provide further color on Global DANYELZA sales for the second quarter of 2024.

現在，我將把電話轉給 Sue Smith，以提供 2024 年第二季 DANYELZA 全球銷售額的進一步資訊。

Thank you, Mike, and good morning, everyone. As you heard from Mike, we are pleased with the commercial traction of DANYELZA, both in the US and across our ex US markets. As more competition arises in the form of new market entrants and clinical trials, we're continuing to sharpen our strategic commercial efforts and remain confident in the unique features and benefits DANYELZA is bringing to neuroblastoma patients.

謝謝你，麥克，大家早安。正如您從 Mike 那裡聽到的，我們對 DANYELZA 在美國和美國以外市場的商業吸引力感到滿意。隨著新市場進入者和臨床試驗形式出現更多競爭，我們將繼續加強我們的策略性商業努力，並對 DANYELZA 為神經母細胞瘤患者帶來的獨特功能和益處保持信心。

In the second quarter of 2024, total worldwide DANYELZA net product revenues were $22.8 million, a 10% increase compared to the same period last year, primarily driven by an increase in international orders. Breaking out US and ex-US, In the US, our second quarter 2024 DANYELZA net product revenues were $15.2 million, a decrease of 4% compared to the second quarter of 2023.

2024年第二季度，DANYELZA全球產品淨收入總額為2,280萬美元，較去年同期成長10%，主要受到國際訂單增加的推動。按美國和美國以外地區劃分，在美國，2024 年第二季 DANYELZA 產品淨收入為 1,520 萬美元，較 2023 年第二季下降 4%。

The Q2 softness was driven by a volume decrease due to the launch of competing therapy in another class of agents and some ongoing clinical trial activity. Ex-US, our second quarter 2024 DANYELZA net product revenues were $7.6 million an increase of 55% compared to the second quarter of 2023.

第二季度的疲軟是由於另一類藥物的競爭療法的推出以及一些正在進行的臨床試驗活動導致銷售下降。除美國外，我們 2024 年第二季 DANYELZA 淨產品收入為 760 萬美元，比 2023 年第二季成長 55%。

In the US, our dedicated team is continuing to advance our new DANYELZA campaign aimed to reposition and elaborate on DANYELZA's differentiating characteristics in the treatment of high-risk neuroblastoma for patients who are refractory or have experienced in complete response to induction therapy in their bone and bone marrow.

在美國，我們的專業團隊正在繼續推進我們新的DANYELZA 活動，旨在重新定位和闡述DANYELZA 在治療高風險神經母細胞瘤方面的差異化特徵，適用於難治性或對骨骼和神經誘導治療有完全反應的患者。

The critical piece of this new campaign highlights DANYELZA's performance in two different patient populations. Those patients with an incomplete response to induction therapy and patients who are relapsed after prior therapy. This campaign also highlights DANYELZA's response in children who had previously received anti-GD2 therapy.

這項新活動的關鍵部分強調了 DANYELZA 在兩個不同患者群體中的表現。對誘導治療反應不完全的患者以及先前治療後復發的患者。該活動還強調了 DANYELZA 對先前接受過抗 GD2 治療的兒童的反應。

Additionally, we recently rolled out a new direct-to-consumer campaign that specifically speaks to the needs of parents. As Mike mentioned, competition is good for patients, particularly in the rare disease space, that predominantly impacts young children.

此外，我們最近推出了一項新的直接面向消費者的活動，專門滿足父母的需求。正如麥克所提到的，競爭對患者有利，特別是在主要影響幼兒的罕見疾病領域。

The treatment approach for each individual patient may be different. We have seen the positive impact DANYELZA has had on children with high-risk relapsed, refractory neuroblastoma in the bone and bone marrow, and believe we are only at the beginning of unlocking the potential of DANYELZA in our mission of improving the lives of patients and their families.

每個患者的治療方法可能有所不同。我們已經看到DANYELZA 對患有高風險復發、難治性骨和骨髓神經母細胞瘤的兒童產生的積極影響，並相信我們才剛開始釋放DANYELZA 的潛力，以實現我們改善患者生活和治療的使命。

A total of 65 accounts have now used DANYELZA around the US since its initial launch in 2021, with 7 new accounts added in the first 6 months of 2024. DANYELZA's total share of the US anti-GD2 market is currently at approximately 17%.

自 2021 年首次推出以來，目前美國各地已有 65 個帳戶使用 DANYELZA，2024 年前 6 個月新增了 7 個帳戶。DANYELZA 目前在美國抗 GD2 市場的總份額約為 17%。

Physician utilization of DANYELZA continues to grow, 30 healthcare practitioners started patients on DANYELZA in the first half of 2024, with four physicians starting treatment on two or more patients. Since the launch, a total of 108 healthcare providers have prescribed DANYELZA and 31 of those have started treatment on two or more patients.

醫生對 DANYELZA 的使用持續成長，2024 年上半年，30 名醫療保健從業人員開始對患者使用 DANYELZA，其中 4 名醫生開始對兩名或更多患者進行治療。自推出以來，共有 108 家醫療保健提供者開出了 DANYELZA 處方，其中 31 家已開始對兩名或更多患者進行治療。

Our dedicated US commercial sales team continues to receive positive healthcare provider feedback on DANYELZA through ongoing customer interactions. In addition, we continue to see institutional adoption of DANYELZA, which was added to 2 hospital formularies in the second quarter of 2024, bringing the total since launch to 46 hospital formularies as of June 30, 2024.

透過持續的客戶互動，我們專門的美國商業銷售團隊繼續收到醫療保健提供者對 DANYELZA 的積極回饋。此外，我們繼續看到 DANYELZA 被機構採用，該藥物於 2024 年第二季度被添加到 2 家醫院處方集中，截至 2024 年 6 月 30 日，該藥物自推出以來總數達到 46 家醫院處方。

Now turning to our ex US commercial progress. We saw a boost in international orders in the second quarter versus the first quarter of this year, driven by recent launches and the continued traction our ex-US distribution partners are gaining across their markets. This second quarter marked the first quarter of DANYELZA sales in Brazil and Mexico, led by our South America partner, Adium.

現在轉向我們前美國的商業進展。由於最近推出的產品以及我們的前美國分銷合作夥伴在其市場上獲得的持續吸引力，我們看到第二季的國際訂單比今年第一季增加。第二季度是 DANYELZA 在巴西和墨西哥銷售的第一季度，由我們的南美合作夥伴 Adium 領導。

We expect to see additional adoption over the coming quarters and learn more about market dynamics in these regions. In Asia, our SciClone partner continues to expand use of DANYELZA in China. Additionally, we're thrilled to have received approval for DANYELZA in Hong Kong and look forward to working with our Eastern Asia partner, SciClone in anticipation of their commercial launch of DANYELZA in Hong Kong.

我們預計在未來幾季將看到更多的採用，並進一步了解這些地區的市場動態。在亞洲，我們的 SciClone 合作夥伴繼續擴大 DANYELZA 在中國的使用。此外，我們很高興 DANYELZA 在香港獲得批准，並期待與我們的東亞合作夥伴 SciClone 合作，期待 DANYELZA 在香港的商業上市。

Despite variability in orders, particularly in the US during the summer months, we have continued to see an overall upward trend of sales growth since the initial launch back in 2021.

儘管訂單存在變化，尤其是在美國夏季的幾個月，但自 2021 年首次推出以來，我們繼續看到銷售成長的整體上升趨勢。

We look forward to providing further updates throughout the year. I will now pass the call to Vignesh.

我們期待全年提供進一步的更新。我現在將把電話轉給維涅什。

Thank you, Sue, and hello, everyone. I'm pleased to provide a brief update on our ongoing investigator-sponsored naxitamab clinical trials. We continue to evaluate potential label expansion opportunities for DANYELZA in collaboration with several leading KOLs and institutions.

謝謝你，蘇，大家好。我很高興提供有關我們正在進行的由研究者資助的納西他單抗臨床試驗的簡短更新。我們繼續與幾家領先的 KOL 和代理商合作，評估 DANYELZA 潛在的品牌擴張機會。

Let me begin with an update on the multicenter investigator-sponsored trial for naxitamab in patients with second-line relapsed osteosarcoma led by Memorial Sloan Kettering Cancer Center. In late June 2024, we received a preliminary draft abstract of certain results from MSK on this trial.

首先讓我介紹一下由紀念斯隆凱特琳癌症中心領導的多中心研究者資助的納西他單抗治療二線復發骨肉瘤患者試驗的最新情況。2024 年 6 月下旬，我們收到了 MSK 斯隆針對該試驗的某些結果的初步摘要草案。

For the 39 patients in the study with pulmonary only recurrence, the summary stated there were 14 event-free patients at 12 months rather than MSK's primary endpoint of 16 event-free patients at 12 months. Analysis of the full study results is still underway. Once we obtain the full data set from MSK, we plan to undertake further analysis of efficacy, including primary and secondary endpoints, evaluate tumor GD2 expression in study subjects and the degree of correlation with clinical response.

對於研究中的 39 名僅肺部復發的患者，總結指出有 14 名患者在 12 個月時無事件，而不是 MSK 斯隆的主要終點為 16 名在 12 個月時無事件患者。完整研究結果的分析仍在進行中。一旦我們從 MSK 獲得完整的數據集，我們計劃進行進一步的療效分析，包括主要和次要終點，評估研究對像中腫瘤 GD2 的表達以及與臨床反應的相關程度。

We intend to use the results of such further analysis to inform our determinations with respect to potential further development of naxitamab-based immunotherapy in patients with relapsed osteosarcoma. The complete results from this trial are expected to be presented by MSK investigators later this year at a medical meeting.

我們打算利用此類進一步分析的結果來指導我們對復發性骨肉瘤患者基於納西他單抗的免疫療法的潛在進一步開發的決定。該試驗的完整結果預計將由 MSK 斯隆研究人員在今年稍後的醫學會議上公佈。

In the frontline high-risk neuroblastoma setting, our partner the Beat Childhood Cancer Research Consortium, or BCC, is leading a multicenter Phase II trial evaluating naxitamab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma. 17 sites have been opened and 10 patients have been treated to date with the recruitment ongoing. The amended protocol for the transition to a randomized trial is currently in process and being evaluated.

在一線高風險神經母細胞瘤環境中，我們的合作夥伴Beat Childhood Cancer Research Consortium (BCC) 正在領導一項多中心II 期試驗，評估naxitamab 與標準誘導治療相結合對新診斷的高風險神經母細胞瘤患者的療效。迄今為止，已開設 17 個站點並治療了 10 名患者，招募工作仍在進行中。目前正在製定並評估過渡到隨機試驗的修訂方案。

The BCC continues to expect the trial to transition from a single-arm trial with naxitamab added to current standard treatment for induction to a randomized trial later this year, where the control arm will be the current standard of care for induction therapy, which is chemotherapy for which we plan to file an IND.

BCC 繼續預計該試驗將從在當前標準誘導治療中添加納西他單抗的單臂試驗過渡到今年晚些時候的隨機試驗，其中對照組將是當前誘導治療（即化療）的標準治療我們計劃為此提交IND。

Our aim for the randomized trial is to demonstrate superiority in complete response at the end of induction therapy in the naxitamab versus the standard of care. In triple-negative breast cancer, we are partnering with the Ohio State University on a Phase Ib/II trial, investigating TGF-beta NK cells, gemcitabine and naxitamab in patients with GD2-positive metastatic breast cancer.

我們進行隨機試驗的目的是證明納西他單抗誘導治療結束時完全緩解相對於標準護理的優越性。在三陰性乳癌方面，我們正在與俄亥俄州立大學合作進行 Ib/II 期試驗，研究 TGF-β NK 細胞、吉西他濱和納西他單抗對 GD2 陽性轉移性乳癌患者的作用。

Two patients have been enrolled and both have been treated with the initial combination of gemcitabine and NK cells. The study is designed to evaluate safety in the first three patients treated with gemcitabine and NK cells. If this combination is well tolerated, naxitamab will be added to the combination treatment for subsequent patients. We expect the first patient to be treated with the addition of naxitamab by the end of this year.

兩名患者已入組，並且都接受了吉西他濱和 NK 細胞的初始聯合治療。該研究旨在評估前三名接受吉西他濱和 NK 細胞治療的患者的安全性。如果這種聯合治療耐受性良好，納西他單抗將被添加到後續患者的聯合治療中。我們預計第一例患者將在今年年底前接受添加納西他單抗的治療。

Upon the outcome of this trial, if the data supports doing so, we would consider moving forward with the multicenter Phase II trial. In addition, we are in discussions with MD Anderson Cancer Center to initiate a multicenter Phase I/II study with a Phase I run-in that seeks to test the hypothesis that the addition of naxitamab to current standard of care will increase the objective response rate in patients with metastatic triple-negative breast cancer who have received at least one prior-line of systemic therapy for metastatic disease.

根據該試驗的結果，如果數據支持這樣做，我們將考慮推進多中心二期試驗。此外，我們正在與 MD 安德森癌症中心討論啟動一項多中心 I/II 期研究，並進行 I 期磨合，旨在檢驗將 naxitamab 添加到當前護理標準中將提高客觀緩解率的假設患有轉移性三陰性乳癌且已接受至少一種先前的轉移性疾病全身性治療的患者。

The study, which is anticipated to start in mid-2025 will further inform us on a future Phase II program in triple-negative breast cancer. In patients with refractory viewing sarcoma, the Institute of Mother and Child in Poland is leading a randomized Phase II trial, evaluating the efficacy and safety of naxitamab. This trial was initiated during the fourth quarter of 2023.

這項研究預計於 2025 年中期開始，將為我們進一步了解未來三陰性乳癌的 II 期計畫。對於難治性視覺肉瘤患者，波蘭母嬰研究所正在領導一項隨機 II 期試驗，評估 naxitamab 的療效和安全性。該試驗於 2023 年第四季啟動。

three patients have been dosed in the naxitamab arm to date and recruitment is ongoing. We expect a total of 16 patients in that arm. The trial is expected to be completed in 2028. we believe a significant treatment gap remains in this anti-GD2 space in both pediatric and adult cancers. We are committed to supporting the advancement of these investigator-sponsored studies through clinical development and working to unlock the untapped potential of naxitamab.

迄今為止，納西他單抗組已對三名患者進行了給藥，招募工作正在進行中。我們預計該組共有 16 名患者。該試驗預計將於 2028 年完成。我們致力於透過臨床開發支持這些研究者資助的研究的進展，並努力釋放納西他單抗尚未開發的潛力。

Let me now hand the call over to Pete Pfreundschuh.

現在讓我將電話轉交給 Pete Pfreundschuh。

Thank you, Vignesh, and good morning, everyone. As you heard earlier from Mike and Sue, total DANYELZA net product revenues of $22.8 million in the second quarter of 2024 represented a 10% increase compared to $20.8 million total DANYELZA net product revenue in the second quarter of 2023, primarily driven by increased international revenues.

謝謝你，維涅什，大家早安。正如您之前從Mike 和Sue 那裡聽到的，2024 年第二季度DANYELZA 產品淨收入總額為2280 萬美元，與2023 年第二季度DANYELZA 產品淨收入總額2080 萬美元相比增長了10%，這主要是由於國際收入增加所致。

The increase of total DANYELZA net product revenue, net in the quarter ended June 30, 2024, compared to the quarter ended June 30, 2023, was a result of the increased volume from Western Europe as well as commercial launches for Brazil and Mexico and Latin American region. US DANYELZA net product revenues were $15.2 million and $15.9 million for the three months ended June 30, 2024, and 2023, respectively, representing a 4% decline.

與截至 2023 年 6 月 30 日的季度相比，截至 2024 年 6 月 30 日的季度 DANYELZA 淨產品總收入有所增加，這是由於西歐銷量增加以及巴西、墨西哥和拉丁市場的商業推出美洲地區。截至2024年6月30日及2023年6月30日的三個月，美國DANYELZA產品淨收入分別為1,520萬美元及1,590萬美元，下降4%。

Our total DANYELZA net product revenue was $42.2 million with 6 months ended June 30, 2024, an increase of 3% as compared to $41 million in the comparable period in 2023. The increase in total DANYELZA net product revenue was primarily driven by a $1.2 million increase in US DANYELZA net product revenue in the six months ended June 30, 2024, while ex US net product revenue was relatively flat. We did not have licensing revenue for the three months ended June 30, 2024, and 2023. We reported $0.5 million of licensing revenue in the six months ended June 30, 2024, and did not have licensing revenue for the 6 months ended June 30, 2023.

截至 2024 年 6 月 30 日的 6 個月，我們的 DANYELZA 產品淨收入總額為 4,220 萬美元，比 2023 年同期的 4,100 萬美元增長了 3%。DANYELZA 淨產品收入總額的成長主要是由於截至 2024 年 6 月 30 日的六個月中，美國 DANYELZA 淨產品收入增加了 120 萬美元，而美國除外的淨產品收入相對持平。截至2024年6月30日和2023年6月30日止的三個月，我們沒有授權收入。我們報告了截至2024年6月30日的六個月的許可收入為50萬美元，而截至2023年6月30日的六個月沒有許可收入。

Moving to operating expenses. Our research and development expenses were $12.3 million and $25.6 million for the quarter and six months ended June 30, 2024, which were relatively flat compared to $12.1 million and $25.5 million for the quarter and six months ended June 30, 2023. Selling, general and administrative expenses increased by $5.9 million and $5.1 million to $17.2 million and $28.7 million for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023.

轉向營運費用。截至2024年6月30日的季度和六個月，我們的研發費用分別為1230萬美元和2560萬美元，與截至2023年6月30日的季度和六個月的1210萬美元和2550萬美元相比相對持平。截至2024年6月30日的三個月和六個月，與2023年同期相比，銷售、一般和管理費用分別增加了590萬美元和510萬美元，達到1720萬美元和2870萬美元。

The increase in selling, general and administrative expenses for the three and six months ended June 30, 2024, were primarily attributable to a net impact of $3.8 million in charges related to two legal settlements that were finalized in the second quarter of 2024, which is net of anticipated insurance proceeds.

截至2024 年6 月30 日的三個月和六個月的銷售、一般和管理費用增加，主要歸因於與2024 年第二季度最終確定的兩項法律和解相關的380 萬美元費用的淨影響，即扣除預期保險收益。

We recorded a net loss for the quarter ended June 30, 2024, of $9.2 million or a negative $0.21 per basic and diluted share compared to a net loss of $6.3 million or a negative $0.14 per basic and diluted share for the quarter ended June 30, 2023.

截至2024 年6 月30 日的季度淨虧損為920 萬美元，即每股基本股和稀釋股負0.21 美元，而截至6 月30 日的季度淨虧損為630 萬美元，即每股基本股和稀釋股負0.14 美元。

In addition, we have reported a net loss for the six months ended June 30, 2024, of $15.9 million or a negative $0.36 per basic and diluted share compared to a net loss of $12.7 million or a negative $0.29 per basic and diluted share for the six months ended June 30, 2023. The increase in net loss for the three and six months ended June 30, 2024, was primarily driven by the previously mentioned two legal settlements with a net $3.8 million impact.

此外，我們報告截至2024 年6 月30 日的六個月淨虧損為1,590 萬美元，即每股基本股和稀釋股負0.36 美元，而淨虧損為1,270 萬美元，即每股基本股和稀釋股負0.29 美元。截至 2024 年 6 月 30 日的三個月和六個月的淨虧損增加，主要是由前面提到的兩項法律和解造成的，淨損失為 380 萬美元。

As mentioned earlier, we ended the second quarter of 2024 with cash and cash equivalents of $77.8 million compared to $78.6 million at year-end 2023. The decrease was $0.8 million year-to-date.

如前所述，截至 2024 年第二季度，我們的現金和現金等價物為 7,780 萬美元，而 2023 年年底為 7,860 萬美元。今年迄今減少了 80 萬美元。

Importantly, we continue to maintain a strong balance sheet reporting $2.1 million in cash inflows for the second quarter of 2024, an improvement from $5 million cash burn in the same period in 2023. Turning now to our full year 2024 guidance. We are revising our full year 2024 total net revenue to be in a range of between $87 million and $95 million from our previous guidance in the range of between $95 million to $100 million.

重要的是，我們繼續保持強勁的資產負債表，2024 年第二季現金流入達 210 萬美元，較 2023 年同期的 500 萬美元現金消耗有所改善。現在轉向我們的 2024 年全年指導。我們正在將 2024 年全年總淨收入從先前的 9,500 萬美元到 1 億美元的指導範圍調整為 8,700 萬美元到 9,500 萬美元之間。

Although our current guidance is reduced for 2024, we believe that DANYELZA will return to higher growth rates in the second half of 2024 as we execute our refined commercial strategy and work to deliver new clinical data that could potentially lead to expanded indications and greater physician adoption. We continue to anticipate operating expenses to remain in the range of between $115 million and $120 million, which is consistent with our prior guidance.

儘管我們目前對2024 年的指導有所降低，但我們相信DANYELZA 將在2024 年下半年恢復更高的成長率，因為我們執行完善的商業策略並努力提供新的臨床數據，這些數據可能會導致適應症的擴大和更多的醫生採用。我們繼續預計營運費用將保持在 1.15 億美元至 1.2 億美元之間，這與我們先前的指導一致。

And we expect our cash burn for the full year 2024 to remain in the range of between $15 million and $20 million, which is consistent with our prior guidance. We continue to expect our cash and cash equivalents to support our commercial operations and pipeline programs as currently planned into 2027. As we noted in previous quarters, the underlying assumptions for this guidance are important to understand.

我們預計 2024 年全年的現金消耗將保持在 1500 萬美元至 2000 萬美元之間，這與我們先前的指導一致。我們繼續預計我們的現金和現金等價物將支持我們目前計劃到 2027 年的商業營運和管道項目。正如我們在前幾個季度所指出的，理解本指南的基本假設非常重要。

For the purpose of this specific analysis of cash runway only, minimal growth in DANYELZA net product revenues is assumed to be part of the analysis. Although we are seeing slower single-digit growth for the first half of 2024 than previously anticipated and communicated, primarily driven by competition for patients as a result of increased clinical trial activity in the US.

僅出於對現金跑道的具體分析的目的，假設 DANYELZA 淨產品收入的最小增長是分析的一部分。儘管我們看到 2024 年上半年的個位數成長速度比之前預期和通報的要慢，這主要是由於美國臨床試驗活動增加導致患者競爭所致。

We believe DANYELZA will continue to grow in future periods, and this will not have a material impact on our cash flow guidance. We believe that DANYELZA will return to higher growth rates in the second half of 2024 as we execute our refined commercial strategy and work to deliver new clinical data that potentially could lead to expanded indications and greater physician adoption.

我們相信 DANYELZA 將在未來持續成長，這不會對我們的現金流指引產生重大影響。我們相信，隨著我們執行完善的商業策略並努力提供新的臨床數據，DANYELZA 將在 2024 年下半年恢復更高的成長率，這些數據可能會導致適應症的擴大和更多的醫生採用。

In terms of development activities, we have assumed that all of our programs will be advancing at our own expense, no new programs other than the ones that are planned and its studies and trials are assumed at this point for the purposes of this analysis. With a strong balance sheet and a focused strategy, we believe Y-mAbs is well positioned to execute on our strategic mission and priorities and to support the delivery of multiple anticipated milestones as we move ahead.

在開發活動方面，我們假設我們所有的項目都將由我們自費推進，除了已計劃的項目及其研究和試驗之外，出於分析目的，目前假設沒有新的項目。憑藉強大的資產負債表和重點突出的策略，我們相信 Y-mAbs 能夠很好地執行我們的策略使命和優先事項，並在我們前進的過程中支持實現多個預期里程碑。

This concludes the financial update. And now I will turn the call back over to Mike.

財務更新到此結束。現在我將把電話轉回給麥克。

Thank you for that overview, Pete. Now let's open the line for questions. Operator?

謝謝你的概述，皮特。現在讓我們打開提問熱線。操作員？

(Operator Instructions) Etzer Darout, BMO Capital Markets.

（操作員指令）Etzer Darout，BMO 資本市場。

Great. First one I had was on sort of the frontline BCC study. Just wondered if you could talk about how many patients maybe you anticipate enrolling in the randomized portion of that study? And I had a follow-up on SADA.

偉大的。我的第一個研究是關於前線 BCC 研究。只是想知道您是否可以談談您預計有多少患者參加研究的隨機部分？我對 SADA 進行了跟進。

Great. Thank you, Etzer. As far as the BCC study, I'll pass that off to Vigensh. So Vigensh can inform you a little bit more on the study. Vignesh.

偉大的。謝謝你，埃澤爾。至於 BCC 研究，我會將其轉交給 Vigensh。Vigensh 可以告訴您更多有關這項研究的資訊。維涅什。

Yes. Thank you, Mike. Yes, so the current study, ongoing single-arm study, as Mike mentioned, enrolled 10 patients so far. And we're anticipating transitioning to a randomized study where the design is still being evaluated at the moment. I don't -- I can't give you an exact figure of how many patients that is expected to be. But as soon as we get further details later this year, we will share that.

是的。謝謝你，麥克。是的，正如麥克所提到的，目前正在進行的單臂研究到目前為止已招募了 10 名患者。我們預計將過渡到一項隨機研究，目前該研究的設計仍在評估中。我不知道——我無法告訴你預計有多少患者的確切數字。但一旦我們在今年晚些時候獲得更多細節，我們就會分享。

Great. And then for the Part A of the SADA study. Just wondered if you could learn enough about GD2 expression in the various tumor types you're exploring to start maybe thinking about expansions into specific tumors and Part B or C? Or is this still sort of too early kind of in the process to get to sort of tumor-specific evaluation, if you will, and sort of the subsequent cohorts that you'll be enrolling on Part B, C and beyond?

偉大的。然後是 SADA 研究的 A 部分。只是想知道您是否可以充分了解您正在探索的各種腫瘤類型中的 GD2 表達，以便開始考慮擴展到特定腫瘤以及 B 或 C 部分？或者，如果您願意的話，對於進行某種腫瘤特異性評估以及您將在 B、C 部分及其他部分中註冊的後續隊列來說，這是否仍然為時過早？

That's a good question. As we look at this, we opted to go with a wide basket looking at different tumor expressions, and we'll collect that data. I don't know that we'll have enough patients to have any sound information to focus on one or eliminate one. But we will take all that into account as we move into Part B.

這是個好問題。當我們考慮這個問題時，我們選擇廣泛關注不同的腫瘤表達，並且我們將收集這些數據。我不知道我們是否會有足夠多的患者獲得任何可靠的資訊來關注某一患者或消除某一患者。但當我們進入 B 部分時，我們將考慮所有這些。

Nicole Germino, Truist Securities.

Nicole Germino，Truist 證券公司。

Sorry about that. For GD2-SADA, can you walk us through the experience of data milestones and roughly when we could get some efficacy data from potential part B? I have a quick follow-up.

對此感到抱歉。對於 GD2-SADA，您能否向我們介紹一下資料里程碑的經驗以及我們大概何時可以從潛在的 B 部分獲得一些功效數據？我有一個快速跟進。

Yes, Nicole. As we look at the drug study itself, the -- where we do not -- we're not designed for efficacy in Part A. So what we're looking for is really the safety of the protein and making sure that we can continue to move on to Part B, where we do a dose escalation.

是的，妮可。當我們審視藥物研究本身時，我們並不是為了 A 部分的功效而設計的。

Secondary to that, we're looking for additional information coming from the protein load and the interval between the injection of the protein and the injection of the isotope. So from our Part A, as we concluded later this year is really focused on the safety of the protein with the additional data coming in from the interval as well as the overall protein load that we'll that we'll use to move forward in Part B.

其次，我們正在尋找來自蛋白質負載以及蛋白質注射和同位素注射之間的間隔的附加資訊。因此，從我們的 A 部分來看，正如我們今年稍後得出的結論，我們真正關注的是蛋白質的安全性，以及來自該間隔的額外數據以及我們將用來推進的整體蛋白質負荷。部分。

Okay. Got it. And then (inaudible) more broadly on SADA. So the SADA administration has a [cold protein] infusion that can be administered by the treating oncologist before the isotope infusion. Well, this may be a bit early. Can you help us understand how reimbursement would work out for both the med onc and for the rad onc.

好的。知道了。然後（聽不清楚）更廣泛地討論 SADA。因此，SADA 給藥有一種[冷蛋白]輸注，可以由治療腫瘤科醫生在同位素輸注之前進行注射。嗯，這可能有點早。您能否幫助我們了解 med onc 和 rad onc 的報銷如何進行？

Yes. Again, that's a good question. This is a novel approach in better utilizing the overall infrastructure in both oncologist offices as well as in nuclear medicine. We know there's challenges today with having enough theranostic suites to do long isotope infusions as well as enough nuclear medicine physicians authorized users to be able to take the time to do that. So as we move forward going into our registration trials, we're looking at different opportunities for reimbursement and what that may look like.

是的。再說一遍，這是個好問題。這是一種更好地利用腫瘤科醫生辦公室和核醫學整體基礎設施的新穎方法。我們知道，今天的挑戰是擁有足夠的治療診斷套件來進行長時間同位素輸注，以及足夠的核子醫學醫生授權使用者能夠花時間這樣做。因此，當我們繼續進行註冊試驗時，我們正在尋找不同的報銷機會以及可能的情況。

But that overall is not driving our strategy. Our strategy is to be able to more effectively dose patients to better utilize those resources from both infusion centers as well as nuclear medicine departments and ultimately be able to treat more patients in an effective manner.

但總體而言，這並沒有推動我們的策略。我們的策略是能夠更有效地給病人用藥，更好地利用輸液中心和核子醫學部門的資源，最終能夠有效地治療更多病人。

Justin Walsh, Jones Trading.

賈斯汀·沃爾什，瓊斯貿易公司。

Can you provide any color on your time line expectations for GD2-SADA going forward? Do we have a sense of how long Part B and C might take relative to Part A?

您能否對 GD2-SADA 未來的時間軸預期提供任何資訊？我們是否知道 B 部分和 C 部分相對於 A 部分可能需要多長時間？

That's -- as we have it laid out today, we expect to conclude Part A later this year. and move right into Part B. Now we've been increasing the speed of our recruitment in our trials. So we've been able to recruit rather quickly in Part A as we progress this trial. So looking at Part B, as we take the information from Part A, my expectation would be that we would be able to start treating patients in '25, early '25 with the potential to close that out in '25 or early '26.

正如我們今天所闡述的那樣，我們預計將在今年稍後完成 A 部分。並直接進入 B 部分。因此，隨著試驗的進展，我們能夠在 A 部分中相當快速地招募人員。因此，看看 B 部分，當我們從 A 部分獲取資訊時，我的期望是我們能夠在 25 年、25 年初開始治療患者，並有可能在 25 年或 26 年初結束治療。

Vignesh, anything additional on your side?

Vignesh，您還有什麼意見嗎？

Nothing to add on that. I think that is a reasonable timeframe based on what we've seen so far. Obviously, it's very, very dependent on what results in dosimetry you see along the way. But I think that's about as best estimation we can make at this stage.

對此沒什麼好補充的。根據我們迄今為止所看到的情況，我認為這是一個合理的時間表。顯然，這非常非常依賴您沿途看到的劑量測定結果。但我認為這就是我們現階段可以做出的最佳估計。

Alec Stranahan, Bank of America.

亞歷克·斯特拉納漢，美國銀行。

Maybe a quick follow-up on the last question that was asked. Maybe walk us through how the recruitment has gone versus your expectations for the GD2-SADA studies so far. Any other unique logistical considerations you'd flag to getting these studies either for GD2 or CD38 off the grounds, especially thinking as you move to Parts B and C?

也許是對最後一個問題的快速跟進。也許可以向我們介紹一下到目前為止招募的進展以及您對 GD2-SADA 研究的期望。為了讓這些 GD2 或 CD38 的研究順利開展，您還有其他獨特的後勤考量嗎，尤其是在您轉向 B 和 C 部分時的考慮？

Thank you, Alex. As far as recruitment goes, it was slow at first as we're getting the sites up. Now we've seen an increase in speed and recruitment in our 1001 trial for GD2. I'd expect to see that continue. As far as our 1201, we've recently initiated the first site with the second one right behind it. So we're actively seeking the first patient for our 1201.

謝謝你，亞歷克斯。就招募而言，一開始進展緩慢，因為我們正在建立網站。現在，我們在 GD2 的 1001 試驗中看到了速度和招募方面的進步。我希望看到這種情況繼續下去。就我們的 1201 而言，我們最近啟動了第一個站點，第二個站點緊隨其後。因此，我們正在積極尋找 1201 的第一位患者。

But as we look at this, I would expect as you dose proteins in patients for the first time for physicians to really be judicious in who they select and how. But once you start seeing the safety data rolling in and the lack of DLTs, we see an increase overall in the speed of the trial. So I'm happy with the speed of recruitment. But again, first in human, you do see some lag time. Vignesh, anything additional?

但當我們看到這一點時，我希望當你第一次給患者服用蛋白質時，醫生在選擇誰以及如何選擇時能夠真正明智。但一旦你開始看到安全資料滾滾而來並且缺乏分散式帳本技術，我們就會看到試驗速度整體上有所提高。所以我對招募速度感到滿意。但同樣，首先在​​人類中，你確實會看到一些延遲時間。維涅什，還有什麼需要補充的嗎？

Yes. Just to add, as you know, as Mike mentioned earlier on, this is a complex part of the Phase I strategy, where we set out to test different SADA dose levels all the way from 0.3 up to much higher doses, up to 5, 10 milligrams was original protocol, including testing dosing intervals of two to five days. So we're still in that process at the moment. So it's too soon to determine the optimal combination of permutation, but this is kind of the step-wise process we're taking to actually determine the optimal dose before we get on to Part B.

是的。補充一下，正如您所知，正如 Mike 之前提到的，這是第一階段策略的一個複雜部分，我們開始測試不同的 SADA 劑量水平，從 0.3 到更高的劑量，最多 5， 10 毫克是最初的方案，包括測試兩到五天的給藥間隔。所以我們目前仍處於這個過程中。因此，現在確定最佳排列組合還為時過早，但這是我們在進入 B 部分之前實際確定最佳劑量的逐步過程。

Next question, operator?

下一個問題，接線生？

(Operator Instructions) Mike Ulz, Morgan Stanley.

（操作員指示）Mike Ulz，摩根士丹利。

Maybe just a follow-up on GD2-SADA. Can you remind us for Cohort 5 in Part A, just what dose you're at if you can? And then are there any plans to go to a Cohort 6, for example, or dose higher?

也許只是 GD2-SADA 的後續。您能否提醒我們 A 部分中的第 5 組，如果可以的話，您服用的劑量是多少？例如，是否有計劃進行第 6 組或更高劑量的治療？

Mike, good question. Vignesh, address the Cohort 5.

麥克，好問題。維涅什，向第 5 組演講。

Yes, we're currently in Cohort 5, where we are testing 1 milligram per kilo four-day interval, whether or not what Cohort 5 patients look like will determine how we proceed based on whether a Cohort 6 is required will really depend on the dosimetry. So at the moment, we don't have any immediate thoughts on what that will look like. We'll wait to see what the results show in this Cohort 5. So at the moment, it's 1 milligram and four-day interval.

是的，我們目前處於第 5 組，每四天間隔測試 1 毫克，第 5 組患者的情況是否會決定我們如何根據是否需要第 6 組進行治療，這實際上取決於劑量測定。所以目前我們還沒有任何關於它會是什麼樣子的直接想法。我們將拭目以待，看看第 5 組的結果如何。所以目前是 1 毫克，間隔四天。

John Newman, Canaccord Genuity.

約翰紐曼，Canaccord Genuity。

Just curious with the ongoing DANYELZA launch obviously, you're seeing some expansion internationally, but I'm wondering if you could comment on whether you're continuing to see the duration of therapy mature in the United States and whether going forward, that could make a meaningful contribution to growth?

只是對正在進行的 DANYELZA 上市感到好奇，顯然，您看到了一些國際擴張，但我想知道您是否可以評論一下您是否會繼續看到治療在美國成熟的持續時間以及未來是否可以為增長做出有意義的貢獻？

Thank you, John. For DANYELZA-specific growth, I'll pass this to Sue.

謝謝你，約翰。對於 DANYELZA 特定的成長，我會將其傳遞給 Sue。

Great. Thank you. Yes, we have seen some duration increase actually with some older patients that are added. And in general, we're actually seeing more continued use as our new campaign has data showing efficacy if someone has been on a prior-therapy and has not progressed well on that.

偉大的。謝謝。是的，我們已經看到隨著一些老年患者的增加，持續時間實際上有所增加。總的來說，我們實際上看到了更多的持續使用，因為我們的新活動有數據顯示，如果有人已經接受過先前的治療但進展不佳，則效果良好。

When switching over to our product, we have data showing now that patients with bone or bone marrow involvement actually can get a disease response if they have been on a prior-GD2 therapy. So we're seeing an increase in uptake among physicians in that setting as well.

當改用我們的產品時，我們現在有數據顯示，如果患有骨骼或骨髓受累的患者之前接受過 GD2 治療，他們實際上可以獲得疾病反應。因此，我們看到醫生在這種情況下的接受度也在增加。

Justin Walsh, Jones Trading.

賈斯汀·沃爾什，瓊斯貿易公司。

I'm wondering if you can remind us how you view the relative market opportunity for DANYELZA in frontline induction in high-risk neuroblastoma and osteosarcoma, versus the currently approved relapsed and refractory indication.

我想知道您是否可以提醒我們，與目前批准的複發和難治性適應症相比，您如何看待 DANYELZA 在高風險神經母細胞瘤和骨肉瘤一線誘導中的相對市場機會。

Thank you, Justin. Again, Sue?

謝謝你，賈斯汀。再說一遍，蘇？

Sure. So currently, the bulk of our use is in the relapsed setting in the US and the new campaign has done a nice job of increasing awareness of our efficacy in the refractory setting. And actually, the data that is in our new campaign, does a nice job of separating this out and actually showing that a patient with an incomplete response after any treatment who has residual disease in the bone or bone marrow, this is precisely where we were studied.

當然。因此，目前，我們的大部分用途是在美國的複發環境中，而新的活動在提高人們對我們在難治性環境中的功效的認識方面做得很好。事實上，我們新活動中的數據很好地區分了這一點，並實際上表明，在任何治療後反應不完全的患者，如果骨骼或骨髓中有殘留疾病，這正是我們所處的位置研究過。

So we're starting to see, and we've heard from physicians with the new campaign that they intend to increase their use in both of those settings based on the new data.

因此，我們開始看到，我們從醫生那裡得知，他們打算根據新數據增加在這兩種環境中的使用。

There are no further questions at this time. I would now like to turn the floor back over to Mike Rossi for closing comments.

目前沒有其他問題。我現在想把發言權轉回給邁克·羅西 (Mike Rossi) 發表結束評論。

Thank you all for joining us today to discuss the progress made during the second quarter of this year. Y-mAbs is supported by a strong financial foundation, driven by the growing commercial success and geographic expansion of DANYELZA.

感謝大家今天加入我們討論今年第二季的進展。在 DANYELZA 日益增長的商業成功和地理擴張的推動下，Y-mAbs 得到了強大的財務基礎的支持。

We believe we're uniquely positioned to continue growth while advancing the clinical development of our differentiated radioimmunotherapy platform, SADA-PRIT to potentially deliver better and safer therapeutic options in the treatment of a variety of cancers.

我們相信，我們處於獨特的地位，可以繼續成長，同時推進我們的差異化放射免疫治療平台 SADA-PRIT 的臨床開發，有可能為各種癌症的治療提供更好、更安全的治療選擇。

We look forward to seeing many of you at upcoming investor and medical meetings throughout the fall. Have a great day.

我們期待在整個秋季即將舉行的投資者和醫療會議上見到你們。祝你有美好的一天。

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

今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。