Nanobiotix SA (NBTX) 2024 Q1 法說會逐字稿

Good afternoon and good morning and welcome to the Nanobiotix conference call to discuss updates to our NBTXR3 development plan and our first quarter. Joining me on the call today are Laurent Levy, Co-Founder and Chief Executive Officer; and Bart Van Rhijn, Chief Financial Officer, who will be available during the Q&A section. As a reminder, today's call is being webcast and will be available on our website for replay.

下午好，早上好，歡迎參加 Nanobiotix 電話會議，討論我們的 NBTXR3 開發計劃和第一季的最新情況。今天和我一起參加電話會議的是共同創辦人兼執行長 Laurent Levy；財務長 Bart Van Rhijn 將出席問答環節。謹此提醒，今天的電話會議正在進行網路直播，並將在我們的網站上重播。

I would like to remind you that this call will include forward-looking statements, which may include statements regarding the progress, success and timing of our ongoing and planned clinical trials, collaborations, regulatory filings, data presentations and future research and development efforts among other things.

我想提醒您，本次電話會議將包括前瞻性陳述，其中可能包括有關我們正在進行和計劃的臨床試驗、合作、監管備案、數據演示和未來研發工作的進展、成功和時間表的陳述事物。

These forward-looking statements are based on current information, assumptions and expectations that are subject to change. They are subject to significant risks and uncertainties that could cause the Company's actual results to differ materially from our current expectations. Accordingly, you are cautioned not to place undue reliance on forward-looking statements.

這些前瞻性陳述基於當前資訊、假設和預期，可能會發生變化。它們面臨重大風險和不確定性，可能導致公司的實際結果與我們目前的預期有重大差異。因此，請注意不要過度依賴前瞻性陳述。

Please review the full description of risk factors that can be found in the documents we filed with the AMF in France and SEC in the United States, which are available in the Investor Relations section of our website, along with the press releases issued yesterday and today.

請查看我們向法國 AMF 和美國 SEC 提交的文件中對風險因素的完整描述，這些文件可在我們網站的投資者關係部分中找到，以及昨天和今天發布的新聞稿。

In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, Nanobiotix undertakes no obligation to update them to reflect subsequent events or future circumstances.

此外，任何前瞻性陳述僅代表我們今天的觀點，不應被視為代表我們在任何後續日期的觀點。雖然我們可能選擇在未來某個時候更新這些前瞻性陳述，但 Nanobiotix 不承擔更新這些陳述以反映後續事件或未來情況的義務。

Before turning the call over to Laurent, allow me to highlight that we announced in a separate press release this morning, our first quarter 2024 unaudited cash balance of EUR58.9 million and reaffirmed our cash runway into Q3 2025, which is inclusive of the $20 million milestone we meanwhile received.

在將電話轉交給Laurent 之前，請允許我強調一下，我們今天早上在另一份新聞稿中宣布，我們2024 年第一季度未經審計的現金餘額為5890 萬歐元，並重申我們到2025 年第三季的現金跑道，其中包括20 美元同時，我們收到了 100 萬的里程碑。

With that said, I'd like to turn the call over to Laurent. Please go ahead.

話雖如此，我想把電話轉給勞倫特。請繼續。

Thank you, Craig, and thanks to everyone for joining us today. As Craig mentioned, we issued a press release yesterday highlighting the company's progress in the global development of NBTXR3 and overview of our robust pipeline and expansion strategy.

謝謝你，克雷格，也謝謝大家今天加入我們。正如克雷格所提到的，我們昨天發布了一份新聞稿，強調了該公司在 NBTXR3 的全球開發方面取得的進展，並概述了我們強大的產品線和擴張策略。

For today's call, I would like to begin with an update to our NBTXR3 collaboration and discuss our pathway to long-term growth. Then I will provide closing remarks before opening up the call for questions. Nanobiotix have been long known for the disruptive potential of NBTXR3, a nanoparticle treatment we've been developing for patients with cancer around the world.

在今天的電話會議中，我想先介紹我們 NBTXR3 合作的最新情況，並討論我們的長期成長之路。然後，我將在開始提問之前發表結束語。Nanobiotix 長期以來因 NBTXR3 的顛覆性潛力而聞名，NBTXR3 是我們一直在為世界各地的癌症患者開發的一種奈米顆粒治療方法。

The accomplishments we have achieved through our 20-year history stand as a testament to the hard work of our team, the potential value the industry at-large sheer in our technology as well as the tremendous faith and confidence of our investors and other stakeholders, all in our vision and our plans to get there.

我們在 20 年的歷史中所取得的成就證明了我們團隊的辛勤工作、整個行業對我們技術的潛在價值以及我們的投資者和其他利益相關者的巨大信心和信心，一切都在我們的願景和實現目標的計劃中。

Last summer, we entered into a collaboration with Janssen was potentially more than EUR2.5 billion plus royalties ranging from low 10s to low 20s to expand the worldwide potential of our lead therapeutic candidate, NBTXR3, a potential first in class [radioenhancer] with universal application across solid tumors. As part of the agreement and NBTXR3 is being developed and potentially commercialized globally by Janssen Pharmaceutica, a Johnson & Johnson company.

去年夏天，我們與楊森達成了一項合作，金額可能超過25 億歐元，外加10 多美元到20 多美元的特許權使用費，以擴大我們的主要治療候選藥物NBTXR3 的全球潛力，NBTXR3 是一種潛在的同類首創[放射增強劑]，具有通用性。作為協議的一部分，強生公司旗下楊森製藥公司正在開發 NBTXR3，並可能在全球進行商業化。

Our global license agreement with Janssen as broad as the possibility to deliver outcomes, changing innovation for millions of patients. Today's focus with our partner is to secure the best market for NBTXR3 and our commitment to realize origin answers, medical and economic value remains our most important goal.

我們與楊森簽訂的全球授權協議涵蓋了提供成果的可能性，為數百萬名患者帶來變革創新。今天我們與合作夥伴的重點是確保 NBTXR3 的最佳市場，我們對實現原始答案、醫療和經濟價值的承諾仍然是我們最重要的目標。

We believe this agreement and the scope of therapeutic and market opportunity of NBTXR3 and importantly, further validate our platform and scientific approach. We believe that this collaboration with our partner have the potential to impact the lives of many patients. We believe this because NBTXR3 can treat patients at stage where the disease is local with radiation therapy, which is a treatment is utilized by millions of patients.

我們相信這項協議以及 NBTXR3 的治療範圍和市場機會，重要的是，進一步驗證了我們的平台和科學方法。我們相信，與合作夥伴的合作有可能影響許多患者的生活。我們相信這一點，因為 NBTXR3 可以透過放射療法治療處於疾病局部階段的患者，這種治療方法已被數百萬患者採用。

(inaudible) disease at this stage, we believe could have a fundamental impact on the overall outcome for patients. The alliance with Janssen for co-development and global commercialization of NBTXR3 has achieved significant progress, which we will overview today. We remain focused on the execution to secure a partnership outcomes and drive as much value in the alliance as possible for patients and Nanobiotix many stakeholders.

（聽不清楚）疾病在這個階段，我們相信可能會對患者的整體結果產生根本性影響。與楊森的聯盟在 NBTXR3 的共同開發和全球商業化方面取得了重大進展，我們今天將對此進行概述。我們仍然專注於執行，以確保合作成果，並為患者和 Nanobiotix 的眾多利益相關者在聯盟中創造盡可能多的價值。

Alongside this, Nanobiotix is working to explore and push forward the next generation of nanoparticle based therapies in healthcare. I'm excited to discuss with you today our corporate strategy, which is designed to enable long-term growth from Nanobiotix. Our company is developing three nanoparticle based therapy platform. We plan to leverage the sustainable revenue expected to come from the development and commercialization of NBTXR3 to further advance development of our second platform, curating and the third platform. Building on the success of NBTXR3, we are energized to expand our leadership in nanoparticle based directly, and we'll discuss more on this shortly.

除此之外，Nanobiotix 也致力於探索和推動下一代基於奈米顆粒的醫療保健療法。我很高興今天與您討論我們的企業策略，該策略旨在實現 Nanobiotix 的長期成長。我們公司正在開發三種基於奈米顆粒的治療平台。我們計劃利用 NBTXR3 的開發和商業化帶來的永續收入，進一步推進我們的第二個平台、策劃和第三個平台的開發。在 NBTXR3 的成功基礎上，我們有動力直接擴大我們在奈米顆粒領域的領導地位，我們很快就會對此進行更多討論。

But first, let's start with our efforts to deliver a potentially curative outcome for patients with locally advanced and metastatic cancer with NBTXR3 as this remains our primary focus. As a reminder, or for those new to the story, NBTXR3 is a biologically electron dense nanoparticle designed to be a strong x-ray absorber and radiation amplifier. It is a onetime treatment designed to minimize impact on the patient journey has it is injected directly into the tumor before the first course of radiation treatment where it has been shown to amplify the antitumor activity of the radiation without increasing exposure to healthy tissue.

但首先，讓我們先努力為使用 NBTXR3 的局部晚期和轉移性癌症患者提供潛在的治癒結果，因為這仍然是我們的主要關注點。提醒一下，或者對於那些剛接觸這個故事的人來說，NBTXR3 是一種生物電子緻密奈米顆粒，旨在成為強大的 X 射線吸收劑和輻射放大器。這是一種一次性治療，旨在最大程度地減少對患者旅程的影響，在第一個放射治療療程之前將其直接注射到腫瘤中，已被證明可以增強放射的抗腫瘤活性，而不會增加對健康組織的暴露。

We call this manufacturing universal. We do so because it's based on physics and our radiation interact with the nanoparticle and not on the specificity of the tumor type or the biology of the patient. This mode of action also lend itself to NBTXR3's ability to be combined with many other modes of therapy including chemotherapy regimen and targeted therapy and importantly, immunooncology therapies.

我們稱這種製造為通用製造。我們這樣做是因為它是基於物理學以及我們的輻射與奈米顆粒的相互作用，而不是基於腫瘤類型或患者生物學的特異性。這種作用模式也使 NBTXR3 能夠與許多其他治療模式結合，包括化療方案和標靶治療，以及重要的免疫腫瘤治療。

NBTXR3 is being iterated as a therapeutic candidate with potential to easily integrate into the cancer treatment paradigm for 60% of chemo patient, who will receive radiation as part of their therapeutic regimen each year. To date NBTXR3 has been injecting and rate of patients by leading physicians at several premium clinical research institution in the United States, Europe and Asia.

NBTXR3 正在被迭代為一種治療候選藥物，有可能輕鬆融入 60% 化療患者的癌症治療模式，這些患者每年都會接受放射治療作為其治療方案的一部分。迄今為止，NBTXR3已由美國、歐洲和亞洲多家優質臨床研究機構的頂尖醫師進行注射和病患評估。

To help enable the practice changing potential of NBTXR3 in collaboration with the interventional oncology group at Johnson & Johnson. The current NBTXR3 development program is initially focused on the completion of NANORAY-312, an ongoing pivotal Phase three evaluating the right answer for elderly patients with locally advanced head and neck cancer as well as the launch of a randomized Phase two study evaluating NBTXR3 for patients with stage three non-small cell lung cancer, for which Janssen is fully responsible.

與強生公司的介入腫瘤學小組合作，幫助實現 NBTXR3 改變實踐的潛力。目前的NBTXR3 開發計畫最初專注於完成NANORAY-312，這是一項正在進行的關鍵三期研究，旨在評估患有局部晚期頭頸癌的老年患者的正確答案，並啟動一項評估NBTXR3 對患者的隨機第二期研究患有第三期非小細胞肺癌，楊森對此負有全部責任。

In preparation for potential regulatory submission in the event of a positive and neck trial results, Nanobiotix and Janssen align at the collaborations, joint strategy committee or DSC to transfer the global sponsorship of the Phase three pivotal head and neck cancer trial. Nanobiotix will continue to support Jenssen in the execution of the NANORAY-312 during and after the sponsorship transfer is complete.

為了準備在頸部試驗結果呈陽性時潛在的監管提交，Nanobiotix 和楊森在合作、聯合戰略委員會或 DSC 上進行了協調，以轉移第三階段關鍵頭頸癌試驗的全球贊助。在贊助權轉讓期間和之後，Nanobiotix 將繼續支持 Jenssen 執行 NANORAY-312。

This was a deliberate decision to pursue the transfer sooner rather than later because we believe it's the best decision for the product value and it's sufficient custom markets. In conjunction with the sponsorship transfer following discussions that began in late 2023, the joint strategy committee align to modification to NANORAY-312 that include a protocol amendment, removing the [plant] utility analysis in light of the robust positive top-line data from the expansion part of the study one or two, a Phase one study evaluating and NBTXR3 in a similar population, which provided satisfactory Q4 for the minority trial design, which seen the futility analysis, not useful.

這是一個深思熟慮的決定，宜早不宜遲，因為我們相信這是產品價值的最佳決定，並且有足夠的客製化市場。結合 2023 年底開始的討論後的贊助轉移，聯合戰略委員會調整了對 NANORAY-312 的修改，其中包括協議修訂，根據來自 2023 年末的強勁正面頂線數據刪除了[工廠]效用分析。的擴展部分，一項在類似人群中評估NBTXR3 的第一階段研究，為少數試驗設計提供了令人滿意的Q4，該設計看到了無效分析，沒有用處。

This amendment is subject to review and approval by health authorities in all countries where NANORAY-312 is operational as well as by the sites participating in the study. To date, the amendment has been accepted by health authorities in several regions, including the United States, countries in Europe and Japan.

該修正案須經 NANORAY-312 運作的所有國家衛生當局以及參與研究的地點審查和批准。迄今為止，該修正案已被多個地區的衛生當局接受，包括美國、歐洲國家和日本。

Additionally, Nanobiotix and Janssen agreed to a change in the approach to the planned interim efficacy analysis such as Janssen, will realize and report on the interim data after both the requisite number of events are observed and at the end of the recruitment as of care, which is expected in the first half of 2026 rather than immediately after the requisite number of events as originally planned.

此外，Nanobiotix 和楊森同意改變計劃的中期療效分析方法，例如楊森將在觀察到必要數量的事件後以及在招募結束時實現並報告中期數據，預計在2026 年上半年舉行，而不是在原計劃舉辦完必要數量的活動後立即舉行。

This revised approach helps to ensure that potentially positive interim analysis with us do not introduce a potential bias in the remaining equipment prior to completion of the study. As such, Nanobiotix now expect the interim analysis to be reported after the last patient is recruited in H1 2026.

這種修訂後的方法有助於確保我們進行的潛在積極的中期分析不會在研究完成之前對剩餘設備引入潛在的偏差。因此，Nanobiotix 現在預計將在 2026 年上半年招募最後一名患者後報告中期分析。

Now let's review other significant progress on our NBTXR3 collaboration with Janssen in establishing development operation since executing the global licensing agreements this July. We started with the formation of the joint strategy committee comprised equally of executives from both companies to drive strategic decision making for the global development program. We also activated joint working team that are staffed by both company with an initial focus on manufacturing and preparing NANORAY-312 for global regulatory submission in the event of positive trial results.

現在讓我們回顧一下自今年 7 月執行全球授權協議以來我們與楊森在建立開發業務方面的 NBTXR3 合作的其他重大進展。我們首先成立了由兩家公司的高階主管組成的聯合策略委員會，以推動全球發展計畫的策略決策。我們也啟動了由兩家公司組成的聯合工作團隊，最初的重點是製造和準備 NANORAY-312，以便在試驗結果積極的情況下向全球監管機構提交。

In addition to establishing governance matter, key operational progress has been achieved. Highlights include first Janssen at begin replicating an antibiotic manufacturing process to allow Johnson & Johnson to produce and NBTXR3 in parallel with our own facility in order to increase product availability.

除了建立治理事項外，還取得了關鍵的營運進展。亮點包括楊森首先開始複製抗生素生產工藝，使強生公司能夠與我們自己的工廠並行生產 NBTXR3，以提高產品可用性。

Second, we have started to leverage increased discretionary in kind contribution that way I look at it from Janssen to Nanobiotix that includes tax report for our NANORAY-312 along with payment for manufacturing technical assistance and other product development support services. Said, we achieve the first operational milestone in NANORAY-312, triggering a [EUR20 million] payment in May from Janssen to Nanobiotix. Then the US FDA issued a Study May Proceed letter regarding the protocol for the Janssen lead Phase two study for patients with Phase three non-small cell lung cancer.

其次，我們已經開始利用增加的可自由支配的實物捐助，我從 Janssen 到 Nanobiotix 都這樣看待，其中包括我們的 NANORAY-312 的稅務報告以及製造技術援助和其他產品開發支持服務的付款。據稱，我們在 NANORAY-312 上實現了第一個營運里程碑，觸發了 Janssen 在 5 月向 Nanobiotix 支付的 [2000 萬歐元] 款項。隨後，美國 FDA 發布了一份研究可能進行的信函，內容涉及楊森針對第三期非小細胞肺癌患者的主導第二期研究的方案。

Fifth, we begin elaboration of the overall clinical development plan for NBTXR3 including new indication beyond head and neck cancer and non-small cell lung cancer.

第五，我們開始製定NBTXR3的整體臨床開發計劃，包括頭頸癌和非小細胞肺癌以外的新適應症。

And lastly, Janssen consolidated global development and commercialization rights via the assignment to Janssen of the licensing agreement relating to China and other Asian market and territories from our former Metabasis partner [Lieon]. As you have heard, we've made significant progress with Janssen advancing and NBTXR3.

最後，楊森透過將我們前 Metabasis 合作夥伴與中國和其他亞洲市場和地區相關的授權協議轉讓給楊森，鞏固了全球開發和商業化權利[躺在]。正如您所聽說的，我們在 Janssen 的推進和 NBTXR3 方面取得了重大進展。

It is key to understand that bringing a therapeutic candidate from concept to global registration is an exciting yet daunting proposition for end development stage biotechnology company, even those working within a well-known asset classes with well-established development and regulatory pathways. That is why we believe that our global licensing agreement with Janssen well and continues to be the right move for the patient for health care professional and for all the supporters of NBTXR3's potential.

關鍵是要明白，對於最終開發階段的生物技術公司來說，將治療候選藥物從概念帶到全球註冊是一個令人興奮但令人畏懼的主張，即使是那些在具有完善的開發和監管途徑的知名資產類別中工作的公司也是如此。這就是為什麼我們相信我們與楊森的全球授權協議對於患者、醫療保健專業人員以及所有 NBTXR3 潛力的支持者來說都是正確的舉措。

We are confident that the leadership of the term strategy committee will optimize the probability of success from NANORAY-312. Importantly, our global licensing agreement with Janssen also includes plans to further evolve the NBTXR3 predevelopment pipeline. This plan includes an established framework for potential complementary co-development of relevant indication in the near medium and long term.

我們相信，本次策略委員會的領導將最大限度地提高 NANORAY-312 的成功機率。重要的是，我們與楊森的全球授權協議還包括進一步發展 NBTXR3 預開發管道的計畫。該計劃包括一個既定框架，用於在近中長期潛在地互補共同開發相關適應症。

The joint strategy committee will recommend the next indication beyond the immediate operation priorities in head and neck and non-small cell lung cancer. Our current pipeline beyond Stage three lung and locally advanced head and neck cancer has already shown the expansion potential of NBTXR3 and continues to progress.

聯合戰略委員會將推薦除頭頸癌和非小細胞肺癌目前優先手術之外的下一個適應症。我們目前在第三期肺癌和局部晚期頭頸癌之後的產品線已經顯示出 NBTXR3 的擴展潛力，並且仍在繼續取得進展。

In our I-O combination program, NBTXR3 in combination with anti-PD-1 therapies for patients with recurrent or metastatic head and neck cancer that is naive or resistant to anti-PD-1 treatment with and without with expertise, is being explored in two cohorts in Study 1100, and growth and ongoing Nanobiotix late Phase one clinical trial that has completed dose escalation and in going dose expansion.

在我們的I-O 組合項目中，NBTXR3 與抗PD-1 療法聯合治療復發或轉移性頭頸癌患者，這些患者是初次接受或對抗PD-1 治療有抵抗力的患者，無論是否有專業知識，正在兩在一個隊列中進行探索處於研究 1100 中，以及正在進行的 Nanobiotix 後期一期臨床試驗，該試驗已完成劑量遞增並正在進行劑量擴展。

We expect to present initial data from the head and neck cancer trial expansion cohort at (inaudible) this June. The third quarter of this study, including patients with metastases for multiple primary cancer, will be presented later in 2025. Expansion opportunity in additional cancer setting in the medium to long term are being investigated in several trials that are part of our ongoing collaboration with MD Anderson Cancer Center in Texas.

我們預計在今年 6 月（聽不清楚）提供頭頸癌試驗擴展隊列的初步數據。這項研究的第三季度，包括多原發癌症轉移的患者，將於 2025 年稍後公佈。我們正在與德克薩斯州 MD 安德森癌症中心持續合作的幾項試驗中，正在研究中長期在其他癌症領域的擴展機會。

This includes Phase one study that have completed dose escalation and are in ongoing dose expansion in locally advanced pancreatic cancer and inoperable recurrent lung cancer. And in an ongoing Phase one study in dose escalation evaluating NBTXR3, in combination with chemotherapy in patients with locally advanced federal cancers. We expect multiple readout from this study in the next 12 months.

這包括已完成劑量遞增並正在進行局部晚期胰腺癌和無法手術的複發性肺癌劑量擴大的一期研究。在一項正在進行的劑量遞增第一期研究中，評估了 NBTXR3 與化療聯合治療局部晚期聯邦癌症患者的情況。我們預計研究將在未來 12 個月內多次讀取。

Additionally, several Nanobiotix Late Phase one study had been completed with primary endpoints met in patients with hepatocellular carcinoma with and without liver metastasis and in rectal cancer. Our main focus and priority for InvoCare Valkyrie program is validating the safety and efficacy of radiotherapy activated NBTXR3 and moving to global registration in locally advanced head and neck cancer.

此外，幾項 Nanobiotix 後期第一期研究已經完成，在有或沒有肝轉移的肝細胞癌患者和直腸癌患者中達到了主要終點。我們 InvoCare Valkyrie 計畫的主要重點和優先事項是驗證放射治療激活 NBTXR3 的安全性和有效性，並轉向局部晚期頭頸癌的全球註冊。

These efforts account for the majority of professional and financial resource allocation. Nanobiotix expect to lead a new Phase two randomized study in a new indication in due time. Once NNORAY-312 sponsorship transfer has been completed, additional funding has been secure. An approval has been confirmed by the joint strategy committee.

這些努力佔了專業和財政資源分配的大部分。Nanobiotix 預計將在適當的時候領導一項針對新適應症的新的二期隨機研究。一旦 NNORAY-312 贊助轉移完成，額外的資金就已到位。聯合戰略委員會已確認批准。

Now let's turn to the promising future of Nanobiotix beyond NBTXR3. As the NBTXR3 program moves toward the ultimate goal of reaching millions of patients with cancer around the world, through the execution of our steady, both ongoing and plan, we are working to expand the impact of nanoparticle based therapy in healthcare through continued early stage development of our nanoparticle expertise, which include two additional platform Curadigm, [NOPD].

現在讓我們轉向 Nanobiotix 超越 NBTXR3 的廣闊前景。隨著 NBTXR3 計畫朝著覆蓋全球數百萬癌症患者的最終目標邁進，透過我們穩定、持續和計劃的執行，我們正在努力透過持續的早期開發擴大基於奈米顆粒的治療在醫療保健中的影響我們的奈米粒子專業知識，其中包括兩個額外的平台Curadigm，[NOPD]。

[Like NBTXR3], this platform have been years in the making and we are excited to share some of our progress with you today. Curadigm, as produced in an old primer has its first product candidate which is designed with specific physical chemical properties to allow it's nanoparticles to transiently occupy liver cell responsible for (inaudible). This allow subsequently deliver therapeutics to bypass the liver's clearance mechanism.

[與 NBTXR3 一樣]，這個平台已經醞釀多年，我們很高興今天與您分享我們的一些進展。Curadigm 是在舊引子中生產的，它有其第一個候選產品，該產品具有特定的物理化學特性，使其奈米顆粒能夠暫時佔據肝細胞，從而負責（聽不清楚）。這使得隨後的治療能夠繞過肝臟的清除機制。

This is intended to increase bioavailability and subsequent accumulation of therapeutic in targeted tissue thus following the medicine to do its work. Dates has the potential to see increases in efficacy or decreases in the toxicity or reduction in the native dose of subsequently administered medicines. The OTT platform is based on the principle that nanoparticle materials can interact with and influence neuronal network by other electrical properties.

這樣做的目的是提高生物利用度以及隨後治療劑在目標組織中的積累，從而跟隨藥物發揮作用。棗子有可能提高療效或降低毒性或減少隨後服用的藥物的天然劑量。OTT平台基於奈米粒子材料可以透過其他電特性與神經元網路相互作用並影響神經元網路的原理。

The goal is to potentially enable modulation of malfunction in neuronal network toward a normal state. In particular, the reduction of neuronal hyperactive liability associate with neuropathic pain has been observed in both in vitro and mouse model with several nanoparticle candidates.

目標是有可能將神經網路的故障調節到正常狀態。特別是，在體外和小鼠模型中，使用幾種奈米顆粒候選物都觀察到與神經性疼痛相關的神經元過度活躍傾向的減少。

We expect to provide the next update on planned and operation progress for Curadigm platform in the second half of 2024. As you heard today, we've made significant strategic and operational progress in our NBTXR3 global alliance with Janssen. These include the intended sponsorship transfer of the pivotal NANORAY-312 trail. Modification of the NANORAY-312 to optimize the regulatory pathway and continued ongoing exploration of expansion opportunities for Inditex R3 in other indications.

我們預計將在 2024 年下半年提供有關 Curadigm 平台計劃和營運進展的最新資訊。正如您今天所聽到的，我們與楊森的 NBTXR3 全球聯盟在策略和營運方面取得了重大進展。其中包括關鍵 NANORAY-312 試驗的預期贊助轉移。修改 NANORAY-312 以優化監管途徑，並繼續探索 Inditex R3 在其他適應症中的擴展機會。

These achievements validate the potential of our nanoparticle platform and strongly position us to expand on antibiotics corporate strategy. We plan to allocate some of the expected profit from NBTXR3 offerings to further develop Curadigm and OOcuity nanoparticle platform to foster and enhance long-term growth potential and value of Nanobiotix. We look forward to providing you updates along the way.

這些成就驗證了我們奈米顆粒平台的潛力，並為我們擴展抗生素企業策略奠定了堅實的基礎。我們計劃將 NBTXR3 產品的部分預期利潤用於進一步開發 Curadigm 和 OOcuity 奈米顆粒平台，以培育和增強 Nanobiotix 的長期成長潛力和價值。我們期待為您提供最新資訊。

With that, I will now ask the operator to begin the Q&A session. Operator?

現在，我將要求接線員開始問答環節。操作員？

(Operator Instructions)

（操作員說明）

Jonathan Chang, Leerink Partners.

喬納森·張 (Jonathan Chang)，Leerink 合夥人。

Hey, guys, thanks for taking the questions. First question, can you discuss how you're thinking about strategies to extend the company's cash runway.

嘿，夥計們，感謝您提出問題。第一個問題，您能否討論一下您如何考慮擴大公司現金跑道的策略。

And then second question, can you provide any color on the alignment process with J&J on a global development plan for NBTXR3 and when we might hear more on the potential medium to long-term opportunities. Thank you.

第二個問題，您能否提供有關與強生公司在 NBTXR3 全球開發計劃方面的協調過程的任何信息，以及我們何時可能聽到更多有關潛在中長期機會的信息。謝謝。

Thanks Jonathan. So maybe let's answer the question number two. Before going to question number one and maybe before let's give some context in this shift in sponsorship. I think when we -- if we put ourselves one year ago, the focus of the Company was about getting the true 12 to the interim readout as fast as possible. And that was the context in which we've been operating.

謝謝喬納森。那麼也許讓我們來回答第二個問題。在討論第一個問題之前，也許在之前，讓我們先介紹一下贊助方式轉變的一些背景。我認為，如果我們把自己放在一年前，公司的重點是盡快獲得真正的 12 到臨時讀數。這就是我們一直在運作的背景。

Then last July, we've been signing this deal and the whole idea of this deal being too, with our new partner, making sure that we can reach the largest number of patients possible to grow the pie and to go to market, if I may say. So we've been shifting from having all focused on getting this interim readout as fast as possible to a focus, which is enlarging the number of indications like having the lung cancer, which is, again, a bigger market than head and neck, but also to go in a more secure or derisked way.

然後去年七月，我們與我們的新合作夥伴簽署了這項協議，這項協議的整體理念是，確保我們能夠接觸到盡可能多的患者，以擴大蛋糕並進入市場，如果我可以說。因此，我們已經從專注於盡快獲得臨時讀數轉向關注重點，即擴大肺癌等適應症的數量，這又是一個比頭頸癌更大的市場，但也以更安全或更低風險的方式進行。

So that's why along and around all this discussion we have had on what's the best timing to transfer the sponsorship. We ended up in this decision. So there have been some internal discussion of course at our partner level than there has been an agreement that the GSE and then an endorsement by our Board. So that have been the process to get to this decision.

這就是為什麼我們一直在討論什麼是轉讓贊助的最佳時機。我們最終做出了這個決定。因此，我們的合作夥伴層面當然進行了一些內部討論，並達成了 GSE 協議，然後得到了我們董事會的認可。這就是做出這個決定的過程。

And I think there's a big question about why now versus later. So first of all, in order for J&J to be able to register the product, to start pre-market activity and to launch the product effectively, they need to be a sponsor of this trial. So there was a choice to do it either now or after the interim readout. Given the work and the heavy lifting that represents such a transfer for global trial with 500 patient will take months and months to get there effectively.

我認為有一個很大的問題是為什麼現在而不是以後。因此，首先，為了讓強生能夠註冊該產品、啟動上市前活動並有效地推出該產品，他們需要成為該試驗的贊助商。因此，可以選擇現在或在臨時讀數之後進行。考慮到轉移 500 名患者的全球試驗的工作量和繁重工作，需要數月才能有效地實現這一目標。

So we thought the best thing to do is to do it now take the burden now and don't have this burden post interim readout. Then after the interim readout, assuming the data are positive we can be fully focused on -- and J&J could be fully focused on registering the product and starting a whole market activities. So that's the context in which we operate. And we've been, of course, doing this press release.

因此，我們認為最好的辦法就是現在就承擔起負擔，並且在臨時讀數後就不再有這種負擔。然後，在中期讀數之後，假設數據是正面的，我們可以完全專注於強生公司可以完全專注於註冊產品並啟動整個市場活動。這就是我們運作的背景。當然，我們一直在發布這份新聞稿。

Now, as you mentioned, this is opening a question about the current cash runway and financing that maybe I'll let Bart answer that question.

現在，正如您所提到的，這提出了一個有關當前現金跑道和融資的問題，也許我會讓巴特回答這個問題。

Thank you, Laurent. Thank you, Jonathan for the question. Just to recap, we believe that it's an important step forward in derisking of the assets, positioning it for success and really optimizing its potential for the benefit of patients and HCPs. As we indicated in the press release, the cash runway is unchanged. And yes, it implies that we need to finance through the updated time line that we communicated. That said, we have much data to deliver between now and middle of 2025 for to the milestones that we've shared in the PR and based on prior study results. We look forward with conviction to sharing those updates. And as any other biotech, we have multiple options and we're very confident that we will work through this. And as you may appreciate, we cannot message on either the timing or the compositional sizing of the milestones.

謝謝你，洛朗。謝謝喬納森提出的問題。回顧一下，我們認為這是在降低資產風險、為成功定位並真正優化其潛力以造福患者和醫護人員方面向前邁出的重要一步。正如我們在新聞稿中指出的，現金跑道沒有變化。是的，這意味著我們需要按照我們溝通的更新時間表進行融資。也就是說，從現在到 2025 年中期，我們有大量數據可以提供，以實現我們在 PR 中分享的、基於先前研究結果的里程碑。我們滿懷信心地期待分享這些最新消息。與任何其他生物技術一樣，我們有多種選擇，我們非常有信心能夠解決這個問題。正如您可能理解的那樣，我們無法就里程碑的時間或組成規模發布訊息。

Understood. Thanks for taking my questions.

明白了。感謝您回答我的問題。

Thank you.

謝謝。

Lucy Codrington, Jefferies.

露西·科德林頓，傑弗里斯。

Hi, there.

你好呀。

Thanks for taking my questions. So just again, sorry, the terms of the sponsorship and fixed income. What's the time? What does the timing look like for that whole process? It sounds like you do expect it to be down for that now at the interim readout from first half '26.

感謝您回答我的問題。再次抱歉，贊助和固定收入的條款。幾點了？整個過程的時間安排是怎麼樣的？聽起來你確實預計在 26 年上半年的中期數據中它會下降。

Sorry, but I guess once that sponsorship is transferred this J&J then takeover the financing of that trial and therefore, that alone could help extend your cash runway where it to happen sooner rather than later.

抱歉，但我想一旦贊助轉移給強生公司，就會接管該試驗的融資，因此，僅此一項就可以幫助您擴展您的現金跑道，儘早實現這一目標。

Secondly, just your level of confidence in completing recruitment by first half '26 and therefore the potential timing of that interim and is there a minimum time after the completion of recruitment at which point that interim would needs to take place?

其次，您對在 26 年上半年完成招募的信心程度，以及因此臨時的可能時間安排，以及招募完成後是否有最短時間需要在哪個時間點進行臨時？

And then just in terms of the funding for the new indications that you might take into Phase two, I guess that's on top of your commitment to running funding 312 or if JJ will take over 312 that might free up some funds. Thank you.

然後，就您可能進入第二階段的新適應症的資金而言，我想這超出了您對 312 資金的承諾，或者如果 JJ 接管 312 可能會釋放一些資金。謝謝。

Thank you, Lucy. So first of all, the expected timing for the transfer of the 312. So we are early in the process as the intent has just been agreed in the past few days. So it will take time, that's for sure, but the intention, of course, to complete that way before the interim readout. That's the whole intention of making this transfer now.

謝謝你，露西。首先，312 的預計轉移時間。因此，我們處於這一過程的早期階段，因為過去幾天才剛剛就意向達成一致。因此，這肯定需要時間，但當然，我們的目的是在臨時讀數之前完成這項工作。這就是現在進行此次轉讓的全部目的。

Now in terms of, obviously, this will have some investment on the partner side. Now we're just establishing what's the joint plan not only to transfer the trial but to continue to run the trial up to the end, knowing that there would be no interruption of the trial during the transfer. That's the ball game we're trying to achieve here.

顯然，合作夥伴方面將會有一些投資。現在我們只是製定聯合計劃，不僅要轉移試驗，還要繼續進行試驗直到結束，並且知道在轉移期間試驗不會中斷。這就是我們在這裡想要實現的目標。

So for the financing part and how much this will cost to know how much will it cost to a partner, we can talk to our partner. But on our side, we think for now it's neutral, may look at it in the future to be a big positive, but we can't say more right now because we are, as I said, early in the process.

因此，對於融資部分以及這將花費多少費用，要知道合作夥伴需要花費多少費用，我們可以與我們的合作夥伴交談。但就我們而言，我們認為目前它是中性的，未來可能會被視為一個巨大的積極因素，但我們現在不能說更多，因為正如我所說，我們正處於這一過程的早期階段。

So now to your second question about H1 '26 to get the end of recruitment, I think that's a good estimate that we could qualify as a biotech as conservative estimate. But I would think given the experience for equipment we have and so far plus what we expect to improve the recruitment with the involvement of a partner, we should be able to reach this target. That's within the realm of possibility.

現在，關於你關於 26 年上半年結束招募的第二個問題，我認為這是一個很好的估計，保守估計我們有資格成為生技公司。但我認為，鑑於我們擁有的設備經驗以及迄今為止我們期望在合作夥伴的參與下改進招聘，我們應該能夠實現這一目標。這是有可能的。

So now you asked a question about how the interim will play versus the last patient in and timing for that. So we expect, of course, to get the 283 event before, of course, at the end of equipment. And there's plenty of work that could be done prior to trigger the interim per se.

現在你問了一個問題，關於臨時治療與最後一名患者的比賽將如何進行以及時間安排。所以我們當然期望在裝備結束前獲得283事件。在觸發臨時措施之前還有很多工作要做。

So talking theoretically here, because we again can talk for our partner the idea will be ready to just push the burden and to have almost concomitant last patient in and the interim readout from the try-out. So the sub-question, if I recall correctly was about new indication and how we select and move forward in that direction and what about the finance. First of all, I think that overall in our plan, including the transfer of 312, there's still a lot of work to be done here.

所以在這裡從理論上講，因為我們再次可以為我們的合作夥伴談論這個想法，我們將準備好推動負擔，並讓最後一個患者幾乎同時進入，並從試用中讀取臨時讀數​​。因此，如果我沒記錯的話，子問題是關於新的跡像以及我們如何選擇並朝這個方向前進以及財務方面如何。首先，我覺得整體來說，我們的計劃，包括312的移交，這裡還有很多工作要做。

So we don't expect to have opening bandwidth from the team within the period of the transfer because we'll be heavily working on that versus what we're doing today already. But the new indication, I think we have a large pipeline today showing all the possibility of at least a big part of the possibilities of NBTXR3. And based on that and some other election, who will define what could be a new indication for Nanobiotix and the goal here being when we start freeing up some bandwidth of the team when the transfer is complete, then we could start thinking about adding a new trial.

因此，我們預計在轉移期間不會從團隊中獲得開放頻寬，因為與我們今天已經在做的事情相比，我們將在這方面投入大量精力。但新的跡象，我認為我們今天有一個很大的管道，顯示了 NBTXR3 至少很大一部分可能性的所有可能性。基於此和其他一些選舉，誰將定義 Nanobiotix 的新適應症，這裡的目標是當我們在轉移完成後開始釋放團隊的一些頻寬時，然後我們可以開始考慮添加新的適應症審判。

And this will, of course, depend on potential additional funding in and at a later stage when the milestone payment coming from also the contract we have with a with J&J. So we'll keep you update on that obviously and over time, we can start building all the next opportunity we have for NBTXR3, but also, as we mentioned in the beyond NBTXR3.

當然，這將取決於後期階段潛在的額外資金，屆時里程碑付款也來自我們與強生公司簽訂的合約。因此，我們將隨時向您通報最新情況，隨著時間的推移，我們可以開始為 NBTXR3 建立所有下一個機會，而且，正如我們在超越 NBTXR3 中提到的那樣。

Thank you.

謝謝。

Suzanne van Voorthuizen, Van Lanschot Kempan.

蘇珊娜‧範‧福特赫伊曾 (Suzanne van Voorthuizen)、範‧蘭肖特‧坎潘 (Van Lanschot Kempan)。

Hello, this is Adam on for Ronny. I'm on behalf of Suzanne, thanks a lot for taking my question. I have two question if possible. The first one will be, can you provide some color on how you mean it will be there Phase two in lung cancer and it is not imminent, which are the gatekeeping items here.

大家好，我是羅尼的亞當。我代表蘇珊娜，非常感謝您提出我的問題。如果可能的話我有兩個問題。第一個是，您能否提供一些顏色來說明您如何理解肺癌的第二階段，並且它不是迫在眉睫的，這是這裡的把關項目。

And the second question is more about the new programs the new platform quota assignment or QT? And which kind of updates should we expect in H2 '24? How concrete is that? Are you already working on some project candidates?

第二個問題更多的是關於新節目、新平台配額分配或QT？我們應該在 24 年下半年期待哪些更新？具體有多具體？您是否已經在研究一些候選項目？

Thank you.

謝謝。

Thank you. And so about lung cancer, which is the randomized Phase two trial that J&J is going to run. We've been publishing recently a good update explaining that FDA, green line or get the green light about the protocol design. And obviously, that's going to trigger a number of activities and work around that by our partner.

謝謝。關於肺癌，這是強生公司將要進行的隨機二期試驗。我們最近發布了一個很好的更新，解釋 FDA、綠線或獲得有關協議設計的綠燈。顯然，這將引發我們的合作夥伴進行一系列活動並解決這些問題。

So we can say more at that stage. But I had time always comes in what we do. Then you can imagine that has a warning working as it is to get that done and start as soon as soon as possible, but I think we'll be able to give some updates over time in agreement with our partner about the development of this clinical trial.

所以我們可以在那個階段說更多。但我的時間總是在我們所做的事情上。然後你可以想像有一個警告正在起作用，因為它是為了盡快完成並開始，但我認為隨著時間的推移，我們將能夠與我們的合作夥伴就該臨床的開發達成一致，提供一些更新審判。

Now for the question on Curadigm, and the expected update we want to give again in H2 is about how are we going to build a strategy and a business model around this new platform, which could give not only one product but multiple products and in any case, multiple applications in different therapeutic area.

現在關於Curadigm 的問題，我們想要在下半年再次給出的預期更新是我們將如何圍繞這個新平台建立策略和商業模式，它不僅可以提供一種產品，還可以提供多種產品，並且可以在任何情況下提供案例，在不同治療領域的多種應用。

So as I think I've mentioned in the past few calls. That's a technology that offers many, many opportunities and some of the key thing and key question we would like to answer and discuss with you in H2 is how are we going to build a sustainable business model and with a whole different possibility we have with this type of technology, both on internal development and of course, external collaboration and business development activities.

正如我想我在過去幾次電話中提到的那樣。這項技術提供了很多很多的機會，我們想在下半年與您回答和討論的一些關鍵問題和關鍵問題是，我們將如何建立一個可持續的商業模式，以及我們對此擁有的完全不同的可能性技術類型，包括內部開發，當然還有外部協作和業務開發活動。

Now to your to your question, do we have already a lead in this technology, yes we have multiple products that could be used to continue to develop this platform. But obviously, we'll give you much more on this in H2.

現在回答你的問題，我們是否已經在這項技術上處於領先地位，是的，我們有多種產品可以用來繼續開發這個平台。但顯然，我們將在下半年為您提供更多相關資訊。

Okay. Thank you very much.

好的。非常感謝。

Thank you.

謝謝。

Ramakanth Swayampakula, HCW.

拉馬坎斯·斯瓦安帕庫拉 (Ramakanth Swayampakula)，HCW。

Yes, thank you. This is RK from H.C. Wainwright. Just first on the long-term thinking about Curadigm or OOcuity. So you have certainly generated a lot of validation on your NBTXR3 program and how much of that validation can be transferred into these two new nanoparticle platforms. The reason for the question is, can you point to NBT or sharply if a partner comes in and wants to talk about either Curadigm or OOcuity enough or you need to generate data? And only with that, that sort of data with a partner (inaudible)

是的，謝謝。我是 H.C. 的 RK。溫賴特。首先是關於 Curadigm 或 OOcuity 的長期思考。因此，您肯定已經對 NBTXR3 程序進行了大量驗證，並且其中有多少驗證可以轉移到這兩個新的奈米顆粒平台中。問題的原因是，如果合作夥伴進來並想充分討論 Curadigm 或 OOcuity 或者您需要產生數據，您能否指出 NBT 或尖銳？只有這樣，與合作夥伴的此類數據（聽不清楚）

Thanks for asking that. That's a good question.

謝謝你這麼問。這是個好問題。

Maybe just before I answer this question, I just want to reiterate that on NBTXR3 we still have a lot of work to do and there is a lot of untapped value for this first product within the collaboration we have and the primary focus of this collaboration being and the company being to make that work and also to get the value of this product and collaboration recognized in the value of the Company.

也許在我回答這個問題之前，我只想重申一下，在NBTXR3 上我們還有很多工作要做，在我們的合作中，第一個產品還有很多未開發的價值，而這次合作的主要重點是公司的目標是實現這一目標，並讓該產品的價值和合作在公司的價值中得到認可。

Now we're starting building the future as we've been discussing that and in term of paradigm of OOcuity. There is a broader validation of that of being the introduction of Nano physics based into the ETSK. Now have all products are different and have different therapeutic applications. Of course, we need to generate a number of data to get to a potential partnership and so on.

現在我們正在開始建立未來，正如我們一直在討論的那樣，並以 OOcuity 的範式為基礎。將奈米物理學引入 ETSK 得到了更廣泛的驗證。現在所有的產品都是不同的並且有不同的治療應用。當然，我們需要產生大量數據才能建立潛在的合作夥伴關係等等。

The main difference being that for both platform OOcuity and Curadigm. We are talking here about why technology platform where we can not only work with product and co-develop or license products that we could also start licensing part of the technology to partners for them to develop their own product. So again, there's multiple opportunities here from very short term to medium and long term, and that's what we intend to be able to explain to you in the second part of this year.

主要區別在於 OOcuity 和 Curadigm 平台。我們在這裡談論為什麼我們不僅可以與產品合作並共同開發或授權產品的技術平台，我們還可以開始將部分技術授權給合作夥伴，讓他們開發自己的產品。再說一遍，從短期到中長期，這裡有多種機會，這就是我們打算在今年下半年向您解釋的內容。

So should we expect some sort of a preclinical data from both Curadigm and OOcuity? If not i the second half, but over the next, say, 12 months? And are you trying to do this parallel track? Or I'm just trying to understand how we would be developing all three programs, albeit at a different level of ## development, of course.

那麼我們是否應該期待來自 Curadigm 和 OOcuity 的某種臨床前數據呢？如果不是下半年，而是接下來，比如說 12 個月？你想嘗試做這個平行軌道嗎？或者我只是想了解我們如何開發所有三個程序，當然，儘管處於不同的 ## 開發級別。

Yeah, without giving you any precise date for second half, yes, we'll be able to show to show all this.

是的，在沒有給你任何下半年的具體日期的情況下，是的，我們將能夠展示這一切。

Perfect. Thank you.

完美的。謝謝。

Thank you. There are no further questions. I will now turn the call over to Dr. Levy for his closing remarks and you and maybe before I make some closing remarks, just want to remind the audience that we have been publishing that we will present at ASCO all data on the immuno-oncology program with our lead product and materials factory. And we think there's a data specific application of NBTXR3 is very important in regards to opening new doors and also potential new indication for foreign antibiotics.

謝謝。沒有其他問題了。現在，我將把電話轉交給 Levy 博士，讓他作結束語，也許在我做結束語之前，我只是想提醒觀眾，我們已經發布了，我們將在 ASCO 上展示有關免疫腫瘤學的所有數據與我們的主導產品和材料工廠合作的計劃。我們認為，NBTXR3 的特定應用數據對於為外國抗生素打開新的大門和潛在的新適應症非常重要。

So I hope to see you at that call when we will disclose and explain and discuss the data. And on that note, I'm going to thank you and wish you a very good day and rest of the week and let's say, June for the next piece of news that will come in the few days.

因此，我希望在電話會議上見到您，屆時我們將揭露、解釋和討論這些數據。就此而言，我要感謝您，並祝您度過美好的一天和本週剩下的時間，讓我們說，六月，幾天后將發布下一則新聞。

Thank you very much. And have a great day.

非常感謝。祝你有美好的一天。