Nanobiotix SA (NBTX) 2023 Q4 法說會逐字稿

Good day and welcome to the Nanobiotix business update and full-year 2023 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

大家好，歡迎參加 Nanobiotix 業務更新和 2023 年全年財務業績電話會議。（操作員指示）請注意，今天的會議正在錄音。

At this point, I will now turn the call over to Craig West, Senior Vice President of Investor Relations of Nanobiotix. Please go ahead.

現在，我將把電話轉給 Nanobiotix 投資者關係資深副總裁 Craig West。請繼續。

Thank you. Good afternoon, good morning, and welcome to the Nanobiotix conference call to discuss our full-year 2023 financial and operating results. Joining me on the call today are Laurent Levy, Co-Founder and Chief Executive Officer; and Bart Van Rhijn, Chief Financial Officer.

謝謝。下午好，早上好，歡迎參加 Nanobiotix 電話會議，討論我們 2023 年全年財務和營運業績。今天與我一起參加電話會議的還有共同創辦人兼執行長 Laurent Levy 和財務長 Bart Van Rhijn。

As a reminder, today's call is being webcast and will be available on our website for replay. 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, dates of presentation, and future research and development efforts, among other things.

提醒一下，今天的電話會議正在進行網路直播，您可以在我們的網站上重播。我想提醒您，本次電話會議將包含前瞻性陳述，其中可能包括有關我們正在進行和計劃中的臨床試驗、合作、監管備案、提交日期和未來研究和開發工作的進展、成功和時間安排等的陳述。

These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. They're subject to significant risks and uncertainties that could cause the company's actual results to differ materially from our current expectations.

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。

Accordingly, you are cautioned not to place undue reliance on forward-looking statements. Please review the full description of risk factors that can be found in the documents we filed with the AMF in France and the SEC in the United States, which are available in the investor relations section of our website, along with the press release issued yesterday highlighting our corporate and financial results for the period.

因此，請注意不要過度依賴前瞻性陳述。請查看我們向法國金融市場監管機構 (AMF) 和美國證券交易委員會 (SEC) 提交的文件中所包含的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找到，同時也請查看昨天發布的新聞稿，其中重點介紹了我們該期間的公司和財務業績。

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截至今天的觀點，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間點更新這些前瞻性陳述，但 Nanobiotix 不承擔更新它們以反映後續事件或未來情況的義務。

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

說完這些，我想把電話轉給 Laurent。請繼續。

Thank you, Craig. And thank you everyone for joining us today. As Craig mentioned, we issued a press release yesterday highlighting the company's full-year operating activity and financial results for 2023.

謝謝你，克雷格。感謝大家今天的參加。正如克雷格所提到的，我們昨天發布了一份新聞稿，重點介紹了該公司 2023 年全年的營運活動和財務表現。

For today's call, I would like to begin with an overview of our accomplishments and upcoming milestones before handing the call over to Bart to address the financial results. Then, I will provide closing remarks before opening of the call for questions.

在今天的電話會議上，我想先概述我們所取得的成就和即將到來的里程碑，然後再將電話交給 Bart 來討論財務結果。然後，我將在開始提問之前致結束語。

2023 was an incredible year of progress for Nanobiotix and our program on NBTXR3. Last summer, we entered into a $2.5 billion license agreement with Janssen Pharmaceutical, a Johnson & Johnson company, to expand the worldwide potential of NBTXR3, a potential first-in-class radioenhancer with universal application across solid tumors.

2023 年對於 Nanobiotix 和我們的 NBTXR3 計畫來說是驚人進步的一年。去年夏天，我們與強生公司旗下的楊森製藥達成了一項價值 25 億美元的許可協議，以擴大 NBTXR3 的全球潛力，NBTXR3 是一種潛在的首創放射增強劑，可普遍應用於實體瘤。

Late in 2023, our partner, LianBio, assigned its right to NBTXR3 in China and other Asian markets to Janssen, thus consolidating global development and commercialization rights with Janssen, which is now responsible for the $205 million in milestone potentially available to us with this partnership.

2023 年末，我們的合作夥伴聯拓生物將其在中國和其他亞洲市場的 NBTXR3 權利轉讓給楊森，從而與楊森鞏固了全球開發和商業化權利，楊森目前負責我們透過此次合作可能獲得的 2.05 億美元的里程碑。

We also reported positive data from two key programs, including final and exploratory data from Study 102, our Phase 1 trial in head and neck cancer; as well as initial data from our Phase 1b study supporting expansion potential in pancreatic cancer as part of an ongoing collaboration with MD Anderson. We will discuss these encouraging findings more in depth shortly.

我們還報告了兩個關鍵項目的積極數據，包括 102 號研究（我們的頭頸癌 1 期試驗）的最終和探索性數據；以及作為與 MD Anderson 正在進行的合作的一部分，支持胰腺癌擴展潛力的 1b 期研究的初步數據。我們很快就會更深入地討論這些令人鼓舞的發現。

First, let's start with our global licensing for development and commercialization agreement with Janssen for NBTXR3. This partnership is designed to leverage the complementary strength of both companies, accelerating and broadening the treatment potential of NBTXR3.

首先，讓我們從與 Janssen 簽訂的 NBTXR3 開發和商業化全球授權協議開始。此次合作旨在利用兩家公司的互補優勢，加速並擴大 NBTXR3 的治療潛力。

As part of the agreement, the initial clinical development focus will be on head and neck and lung cancer, with expansion potential in additional solid tumor indications. We believe this agreement underscores the therapeutic and market opportunity of NBTXR3 and importantly, further validate our platform and scientific approach.

作為協議的一部分，最初的臨床開發重點將放在頭頸癌和肺癌上，並具有擴展到其他實體腫瘤適應症的潛力。我們相信，該協議強調了 NBTXR3 的治療和市場機會，更重要的是，進一步驗證了我們的平台和科學方法。

We believe that this collaboration with our partner at the Interventional Oncology Group at J&J has the potential to impact the lives of many patients. We believe this because NBTXR3 can treat patients at the stage of where their disease is local and do so with radiation therapy, which is a treatment utilized by millions of patients. Better local control of disease at this stage, we believe, could have a fundamental impact on overall outcome for patients.

我們相信，與強生介入腫瘤學組的合作夥伴的這項合作有可能影響許多患者的生活。我們之所以相信這一點，是因為 NBTXR3 可以在患者的局部疾病階段進行治療，並且可以透過放射療法進行治療，而放射療法是數百萬患者採用的治療方法。我們相信，現階段更好地局部控制疾病可能會對患者的整體結果產生根本性的影響。

As a reminder, or for those new to the story, NBTXR3 is a biologically inert, electron-dense nanoparticle. It is a one-time treatment that is designed to be injected directly into solid tumor prior to a course of radiation to amplify the anti-tumor activity of radiotherapy.

提醒一下，或者對於那些剛了解這個故事的人來說，NBTXR3 是一種生物惰性、電子密度高的奈米粒子。這是一種一次性治療方法，旨在在放射治療之前直接注射到實體腫瘤中，以增強放射治療的抗腫瘤活性。

NBTXR3 is made up of hafnium oxide, a sterile, inert material with high electron density that acts as a strong energy absorber and increases the amount of energy transferred to the tumor, which in turn leads to cell damage and death.

NBTXR3 由氧化鉿組成，氧化鉿是一種無菌、惰性材料，具有高電子密度，可作為強能量吸收劑，增加轉移到腫瘤的能量，進而導致細胞損傷和死亡。

This universal mode of action of NBTXR3 as a radio enhancer offers broad application potential across 60% of patients with solid tumor that receive radiation during the course of their treatment. This broad potential of NBTXR3 is something that we have been actively evaluating in hundreds of patients across eight tumor types treated today.

NBTXR3 作為放射增強劑的這種通用作用模式為 60% 在治療過程中接受放射治療的實體腫瘤患者提供了廣泛的應用潛力。我們已經在目前接受治療的八種腫瘤類型的數百名患者中積極評估了 NBTXR3 的廣泛潛力。

We continue to see strong proof-of-concept data that support a well-tolerated safety profile and robust anti-tumor activity with radiotherapy-activated NBTXR3 treatments. Our prioritized focus has been the late stage development of NBTXR3 in head and neck cancer, which include an ongoing global registrational trial, the NANORAY-312 study, in elderly patients with locally-advanced head and neck cancer; as well as treatment approach using radiotherapy-activated NBTXR3 to help with local control of the injected tumor as well as initially prime the immune system, followed by anti-PD-1 therapies.

我們繼續看到強有力的概念驗證數據，支持放射治療活化的 NBTXR3 治療具有良好的耐受性安全性和強大的抗腫瘤活性。我們的重點是 NBTXR3 在頭頸癌中的後期開發，其中包括一項正在進行的全球註冊試驗 NANORAY-312 研究，該研究針對患有局部晚期頭頸癌的老年患者；以及使用放射治療激活的 NBTXR3 的治療方法，以幫助局部控制注射的腫瘤以及最初啟動免疫系統，然後進行抗 PD-1 療法。

We believe this combination has the potential to be a game changer for cancer immunotherapy, and it's supported by encouraging data from Study 1100, our Phase 1 trials in patients with advanced cancer, including those that are anti-PD-1 naïve as well as those whom anti-PD-1 therapy has failed.

我們相信，這種組合有可能改變癌症免疫療法的格局，並且來自研究 1100 的令人鼓舞的數據也支持了這一點，研究 1100 是我們對晚期癌症患者進行的 1 期試驗，包括那些抗 PD-1 初治患者以及抗 PD-1 治療失敗的患者。

We also continue to generate additional early-stage data to support the clinical potential of NBTXR3 across different solid tumor indication as part of our collaboration with MD Anderson. This effort includes 500 clinical trials in advanced solid tumor with lung or liver metastasis, recurrent or metastatic head and neck cancer, inoperable non-small cell lung cancer, esophageal cancer, and pancreatic cancer.

作為與 MD Anderson 合作的一部分，我們也將繼續產生額外的早期數據，以支持 NBTXR3 在不同實體腫瘤適應症的臨床潛力。這項工作包括針對肺癌或肝轉移的晚期實體瘤、復發性或轉移性頭頸癌、無法手術的非小細胞肺癌、食道癌和胰腺癌的 500 項臨床試驗。

As I mentioned earlier, the license agreement with Johnson & Johnson has a total potential value of $2.5 billion. And to this, we can now add $205 million related to the rights in Asia that’s found by LianBio to J&J.

正如我之前提到的，與強生公司的授權協議總潛在價值為 25 億美元。除此之外，我們現在還可以加上聯拓生物提供給強生公司的與亞洲權利相關的 2.05 億美元。

The deal values include upfront and intangible and a number of developments and regulatory milestones for the certain indication in head and neck cancer and lung cancer, along with [third] milestone that together potentially total up to $1.8 billion. There are additional regulatory and development milestone for new indications that Janssen made as well over time of up to $650 million in aggregate.

此交易價值包括前期和無形資產以及針對頭頸癌和肺癌特定適應症的一系列發展和監管里程碑，以及[第三個]里程碑，總額可能高達 18 億美元。楊森還針對新適應症制定了額外的監管和開發里程碑，總額高達 6.5 億美元。

For any new indications that Nanobiotix will develop and bring to market, there will be an additional $220 million per new indication. Of course, this deal also includes the royalties that go from low teens to low 20s.

對於 Nanobiotix 開發並推向市場的任何新適應症，每個新適應症將額外獲得 2.2 億美元。當然，這筆交易還包括從十幾歲到二十多歲的版稅。

In June, we have secured $140 million gross in funding, which includes several deal-related payments and equity rate. This equity deal was supported by a major shareholder and also providing J&J the opportunity to become a Nanobiotix shareholder.

6 月份，我們已獲得 1.4 億美元的融資，其中包括幾筆交易相關的付款和股權利率。這項股權交易得到了大股東的支持，也為強生提供了成為 Nanobiotix 股東的機會。

As Bart of the review in more depth shortly, we are pleased to have significantly strengthened our balance sheet, remove the [CID] cash movement, and expand our cash runway into the third quarter of ‘25. Looking ahead, we're strongly positioned to further advance and maximize the rapid potential of NBTXR3 within the solid tumor treatment landscape.

正如 Bart 不久前更深入地介紹的那樣，我們很高興能夠顯著加強我們的資產負債表，消除 [CID] 現金流動，並將我們的現金跑道擴大到 25 年第三季。展望未來，我們已做好準備，進一步推進並最大限度地發揮 NBTXR3 在實體腫瘤治療領域的快速潛力。

Turning to our clinical progress. Earlier this year, we reported positive final safety and efficacy data and a successful completion of Study 102, our Phase 1 dose escalation and expansion study in head and neck cancer at the annual ASTRO meeting. The robust anti-tumor efficacy and well-tolerated profile being in a vulnerable elderly population with high comorbidity burden was encouraging and included 64% complete response rate and 82% overall response rate.

談談我們的臨床進展。今年早些時候，我們在 ASTRO 年度會議上報告了積極的最終安全性和有效性數據，並成功完成了 102 號研究（即針對頭頸癌的 1 期劑量遞增和擴展研究）。對於合併症負擔較重的脆弱老年族群而言，其強大的抗腫瘤功效和良好的耐受性令人鼓舞，包括 64% 的完全緩解率和 82% 的整體緩解率。

We also saw a median progression for survival of 16.9 months and a median overall survival of 23.1 months, which is nearly double survival reported in historical data. This data informed on next step and support the positive underlying design of our registrational NANORAY-312 Phase 3 study.

我們也看到中位總存活期為 16.9 個月，中位總存活期為 23.1 個月，幾乎是歷史數據報告的存活期的兩倍。這些數據為下一步研究提供了信息，並支持了我們註冊 NANORAY-312 第 3 階段研究的積極潛在設計。

Additional signs of efficacy in exploratory analyses presented at the '23 ESMO Congress provide further confidence in our ongoing Phase 3 study, including the 42.8 months median overall survival observed in the 82% evaluable population who had a response in the NBTXR3-injected lesion compared to 18.1 months in the all treated population.

在第 23 屆 ESMO 大會上提出的探索性分析中的其他療效跡象進一步增強了我們正在進行的 3 期研究的信心，包括在 82% 可評估人群中觀察到的 42.8 個月的中位總生存期，這些人群對 NBTXR3 注射病變有反應，而所有接受治療的人群中為 18.1 個月。

Importantly, a positive correlation associated with objective response, PFS, and OS extension was observed in the regulatory activated NBTXR3-injected lesion. This highlight of response in over 80% of treated patient linked to the extended survival beyond 40 months is encouraging and support the potential of NBTXR3 to change treatment [having] in this patient population.

重要的是，在調節活化的 NBTXR3 注射病灶中觀察到與客觀反應、PFS 和 OS 延長相關的正相關性。超過 80% 的接受治療的患者出現反應，且生存期延長至 40 個月以上，這一亮點令人鼓舞，並支持 NBTXR3 改變該患者群體治療方法的潛力。

Importantly, there are several key aspects of this Phase 1 data that give us confidence in the design and potential outcome of our registrational NANORAY-312 study. The first is the extended survival observed in this elderly and highly comorbid population.

重要的是，第一階段資料的幾個關鍵方面讓我們對註冊 NANORAY-312 研究的設計和潛在結果充滿信心。首先是觀察到老年和高合併症族群的生存期延長。

We have also applied learnings from our Phase 1 study, which has the potential to optimize treatment outcome in the Phase 3 trial. This includes injection both of the primary lesion and the possibility to inject lymph nodes in the Phase 3 trial instead of just the primary lesion as was done in Phase 1 study.

我們也運用了第一階段研究的經驗，有可能優化第三階段試驗的治療結果。這包括注射原發病灶和在第三階段試驗中註射淋巴結的可能性，而不是像第一階段研究中那樣只注射原發病灶。

Additionally, 312 will enroll a broader population and will be stratified on comorbidities. Collectively, we believe this modification are potential for immense outcome over our Phase 1 finding.

此外，312 將招募更廣泛的人群，並根據合併症進行分層。總的來說，我們相信這種修改可能會對我們的第一階段的發現產生巨大的影響。

But let's be clear, if we reach similar outcome at our Phase 1 trial, then the 312 should be able to be successful. We expect to report initial Phase 3 interim efficacy and safety data after 67% of planned PFS agents in mid-‘25, which, if positive, could enable eligibility for accelerated approval, as has been discussed with the PFS EFDA.

但我們要明確的是，如果我們在第一階段試驗中取得類似的結果，那麼 312 就應該能夠成功。我們預計將在 2025 年中期報告 67% 的計劃 PFS 藥物的初步第 3 階段中期療效和安全性數據，如果結果為陽性，則可以獲得加速批准的資格，正如與 PFS EFDA 討論的那樣。

In pancreatic cancer, we were pleased to report initial data from our Phase 1b study led by our collaborator partner, MD Anderson, supporting the potential of radiotherapy-activated NBTXR3 after (inaudible) chemotherapy in patients with locally advanced pancreatic cancer at the AACR special conference on pancreatic cancer and ESMO.

在胰臟癌領域，我們很高興在 AACR 胰臟癌特別會議和 ESMO 上報告由我們的合作夥伴 MD Anderson 領導的 1b 期研究的初步數據，該研究支持在局部晚期胰腺癌患者接受化療後放射治療激活 NBTXR3 的潛力。

This trial focuses on patients with large tumors that are unable to undergo surgery and rely on radiation combined with chemotherapy as a key treatment option to help control the tumor. This initial Phase 1b dose escalation data support the feasibility and promising durable anti-tumor efficacy of radiotherapy-activated NBTXR3 in pancreatic cancer.

該試驗針對的是無法接受手術的大型腫瘤患者，並依靠放療合併化療作為控制腫瘤的主要治療選擇。初步的 1b 期劑量遞增數據支持放射治療活化的 NBTXR3 在胰臟癌中的可行性和有希望的持久抗腫瘤功效。

The ESMO data potentially help inform clinical trial development by establishing a recommended Phase 2 dose and demonstrating a favorable safety profile and a preliminary median overall survival of 23 months, which is longer than the 19.2 months median survival achieved in patients who previously received a chemotherapy induction followed by radiation plus a second course of our chemotherapy.

ESMO 數據可能有助於指導臨床試驗開發，因為它可以確定建議的 2 期劑量，並展示良好的安全性和 23 個月的初步中位總生存期，這比之前接受化療誘導、放療加第二療程化療的患者所達到的 19.2 個月的中位生存期要長。

In other words, the same center controlled patients received one additional course of chemotherapy versus NBTXR3-treated patients. To put this into perspective, when we look at the comparative data that have been previously opened by MD Anderson, we are seeing promising therapeutic potential versus this historical control. We plan to discuss this data with our partner, MD Anderson, and Johnson & Johnson to assess potential will make step for patients with pancreatic cancer.

換句話說，與接受 NBTXR3 治療的患者相比，同一中心控制的患者接受了額外的化療。為了更清楚地說明這一點，當我們查看 MD Anderson 之前公開的比較數據時，我們看到了與歷史對照相比有光明的治療潛力。我們計劃與我們的合作夥伴 MD Anderson 和強生公司討論這些數據，以評估對胰臟癌患者的潛在治療效果。

In our efforts to further advance clinical development and commercialization of NBTXR3, we were pleased to welcome industry veteran Dr. Louis Kayitalire to our executive leadership team as Chief Medical Officer. Dr. Kayitalire brings an exceptional biopharmaceutical industry track record with proven success in development, registration, and commercialization of oncology therapy. His seasoned innovative leadership have and will continue to be invaluable as we focus on maximizing the disruptive potential of our radioenhancer for millions of patients with cancer around the world.

在我們進一步推進 NBTXR3 的臨床開發和商業化的過程中，我們很高興歡迎業界資深人士 Louis Kayitalire 博士加入我們的執行領導團隊擔任首席醫療官。Kayitalire 博士在生物製藥行業擁有卓越的業績記錄，在腫瘤治療的開發、註冊和商業化方面取得了成功。當我們專注於最大限度地發揮我們的放射增強劑對全球數百萬癌症患者的顛覆性潛力時，他經驗豐富的創新領導力已經並將繼續發揮其寶貴作用。

In the year ahead, we expect immunotherapy combination data from our Study 1100 trials in head and neck cancer, where we have seen encouraging activity in both PD1 treatment-naive and refractory patients. We also expect initial chemotherapy combination data in esophageal cancer from our MD Anderson collaboration.

在未來的一年裡，我們期待從 1100 項針對頭頸癌的研究試驗中獲得免疫療法組合數據，我們在 PD1 初治患者和難治性患者中都看到了令人鼓舞的活性。我們也期望從與 MD Anderson 的合作中獲得食道癌的初步化療組合數據。

With that, I would like now to turn the call over to Bart to briefly discuss the financial results for the period. Bart?

現在，我想將電話轉給巴特，簡要討論一下該時期的財務表現。巴特？

Thank you, Laurent. Good morning and good afternoon, everyone. As Laurent mentioned earlier, Nanobiotix has had an extremely productive year. And we believe that the company's position has been completely transformed into one where we have set the stage to allow us to deliver on the potential of NBTXR3, the pipeline, and the product.

謝謝你，洛朗。大家早安，下午好。正如 Laurent 之前提到的，Nanobiotix 今年取得了極其豐碩的成果。我們相信，公司的地位已經完全轉變，我們已做好準備，可以充分發揮 NBTXR3、管道和產品的潛力。

More specifically, we began our collaboration with Johnson & Johnson through which we are working to bring NBTXR3 to the millions of patients that suffer from solid tumor malignancies that are amenable to treatment with radiotherapy. The first two indications targeted for development are planned to be head and neck cancers and lung cancers.

更具體地說，我們開始與強生公司合作，致力於將 NBTXR3 帶給數百萬患有實體腫瘤惡性腫瘤且適合放射治療的患者。計劃開發的首兩個適應症是頭頸癌和肺癌。

But it far from the full potential we see possible with a therapy like NBTXR3. And as you've just heard Laurent discussed additional indications such as pancreatic cancer can, we believe, benefit from adding our potentially first-in-class radio enhancer to the treatment armamentarium.

但它遠未發揮我們所看到的 NBTXR3 等療法的全部潛力。正如您剛才聽到的，Laurent 討論了胰腺癌等其他適應症，我們相信，將我們潛在的首創放射增強劑添加到治療設備中可以使其受益。

To date, the company has received $30 million as part of an upfront cash licensing fee, $5 million for the first equity tranche, which was received post signing; $25 million as part of the second equity tranche. And we are due to receive $20 million NANORAY-312 operational milestone.

迄今為止，該公司已收到 3,000 萬美元的前期現金許可費，其中 500 萬美元為簽約後收到的第一筆股權款項，2,500 萬美元為第二筆股權款項。我們將獲得 2000 萬美元的 NANORAY-312 營運里程碑。

And as Laurent mentioned, the company completed an equity offering in which a total of $59 million was raised, which is inclusive of the aforementioned second equity fund of $25 million. And with these events, we have also addressed a significant matter, the financial overhang that was an understandable concern of market participants.

正如 Laurent 所提到的，該公司完成了股權發行，共籌集了 5,900 萬美元，其中包括前面提到的 2,500 萬美元的第二筆股權基金。透過這些事件，我們也解決了一個重要問題，即市場參與者可以理解的擔憂——金融過剩。

As of December 31, 2023, Nanobiotix had EUR75.3 million in cash and cash equivalents, compared to EUR41.4 million as of December 31, 2022. We are grateful for the continued support we receive from existing shareholders, and are pleased to welcome new shareholders in our list.

截至 2023 年 12 月 31 日，Nanobiotix 擁有現金和現金等價物 7,530 萬歐元，而截至 2022 年 12 月 31 日為 4,140 萬歐元。我們感謝現有股東的持續支持，並歡迎新股東加入我們的行列。

As previously disclosed, the European Investment Bank has agreed to the removal of the minimum cash and cash equivalent covenant from the company's EIB loan effective October 13, 2023. As a result of the terms of this new agreements, maybe the repayment of the prepayments, and the recent financing, the company has paid the EIB approximately EUR0.5 million, which is 1% of the net equity proceeds, further to the equity milestone acceleration mechanism the company agreed upon.

如前所述，歐洲投資銀行已同意自 2023 年 10 月 13 日起取消該公司歐洲投資銀行貸款中的最低現金和現金等價物契約。根據該新協議的條款，可能包括預付款的償還以及最近的融資，該公司已向歐洲投資銀行支付了約 50 萬歐元，佔淨股權收益的 1%，這是該公司同意的股權里程碑加速機制的進一步發展。

To turn to the specifics of our revenues and expenses, our top line of EUR36.2 million reflects an increase of EUR31.4 million versus the EUR 4.8 million we recorded in 2022. This was primarily driven by the revenue recognized following the signing of the Janssen agreement.

具體來說，我們的收入和支出為 3,620 萬歐元，比 2022 年的 480 萬歐元增加了 3,140 萬歐元。這主要得益於簽署 Janssen 協議後確認的收入。

Our investment in NBTXR3 increased our R&D expenses approximately EUR5.8 million to a total of EUR 38.4 million, due to primarily the investments related to the pivotal Phase 3 registration study, the NANORAY-312; and our immunotherapy combination study, 1100.

我們對 NBTXR3 的投資使我們的研發費用增加了約 580 萬歐元，達到總計 3840 萬歐元，這主要歸因於與關鍵的 3 期註冊研究 NANORAY-312 和我們的免疫療法組合研究 1100 相關的投資。

Our SG&A expenses increased by EUR4.2 million to EUR22 million for the year ended December 31, 2023. This year-over-year increase reflects growth in employee costs and one-time business activities, including equity issuance costs, license agreement execution, and the termination of the services agreement.

截至 2023 年 12 月 31 日止年度，我們的銷售、一般及行政費用增加了 420 萬歐元，達到 2,200 萬歐元。這一同比增長反映了員工成本和一次性業務活動的成長，包括股權發行成本、許可協議執行和服務協議終止。

Based on the current operating plan and financial projections, we anticipated the cash equivalents of EUR75.3 million as on December 31, 2023, in combination with the $20 million milestone we are due to receive, results in a cash runway that stands into the third quarter of 2025.

根據目前的營運計畫和財務預測，我們預計 2023 年 12 月 31 日的現金等價物為 7,530 萬歐元，加上我們即將收到的 2,000 萬美元里程碑，將形成持續到 2025 年第三季的現金流。

And now, I will turn the call back to Laurent. Laurent?

現在，我將把電話轉回給 Laurent。洛朗？

Thank you, Bart. As you have heard today, we made incredible progress this year, advancing clinical development of NBTXR3, fostering strong strategic partnership to further maximize the potential of NBTXR3, and extending our renewal through key milestones.

謝謝你，巴特。正如您今天所聽到的，我們今年取得了令人難以置信的進展，推進了 NBTXR3 的臨床開發，建立了強有力的戰略合作夥伴關係以進一步發揮 NBTXR3 的潛力，並通過關鍵里程碑延長了我們的更新。

The society of clinical data continue to support the potential of NBTXR3 to offer a meaningful therapeutic benefit to potentially millions of patients in oncology. We are pleased with the progress we have made in our initial focus in head and neck cancer as well as the expansion potential across other indications like pancreatic cancer.

臨床數據協會繼續支持 NBTXR3 的潛力，為數百萬腫瘤患者提供有意義的治療益處。我們對最初在頭頸癌治療領域取得的進展以及在胰臟癌等其他適應症方面的擴展潛力感到滿意。

Looking ahead, we expect multiple clinical readouts in ‘24, including immunotherapy combination data from Study 1100 and new data from the collaboration with MD Anderson. With the recent strengthening of our balance sheet, we believe we are strongly (inaudible) to execute across our near-term milestone and work toward our mission of bringing nanotechnology-derived products like NBTXR3 to more patients worldwide.

展望未來，我們預計 24 年將有多個臨床讀數，包括來自研究 1100 的免疫療法組合數據以及與 MD Anderson 合作的新數據。隨著我們資產負債表的近期增強，我們相信我們有能力（聽不清楚）實現近期里程碑，並努力實現我們的使命，為全球更多患者提供 NBTXR3 等奈米技術衍生產品。

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

現在，我請接線生開始我們的問答環節。操作員？

Thank you. And ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions) Jonathan Chang, Leerink Partners.

謝謝。女士們、先生們，我們現在開始問答環節。（操作員指示）Jonathan Chang，Leerink Partners。

This is Dylan Drakes on for Jonathan. Thanks for taking our question. First of all, could you provide any context for what we should be expecting to see regarding patient numbers, duration of follow-up, and potential readouts in the upcoming ASCO update for Study 1100?

這是 Dylan Drakes 為 Jonathan 表演的。感謝您回答我們的問題。首先，您能否提供一些背景信息，說明在即將發布的 ASCO 1100 研究更新中，我們應該看到哪些有關患者人數、隨訪時長和潛在讀數的信息？

Hi. This is Craig; I'm the Head of IR here at Nanobiotix. It's our understanding that some of our attendees have had trouble connecting to the webcast. I just want to make sure that people know that we are aware of the problem.

你好。我是 Craig；我是 Nanobiotix 的 IR 主管。據我們了解，部分與會者在連接網路直播時遇到了問題。我只是想確保人們知道我們已經意識到了這個問題。

We will post the slides and the replay as soon as possible. We're very sorry for the inconvenience. And I'm sorry, could you repeat your question?

我們將盡快發布幻燈片和重播。我們對由此造成的不便深感抱歉。抱歉，您能重複您的問題嗎？

Yeah, no problem. This is Dylan Drakes on for Jonathan. Just wanted to ask if you could provide any context for what we should be expecting to see regarding patient numbers, duration of follow-up, or potential readouts in the upcoming ASCO update on Study 1100?

是的，沒問題。這是 Dylan Drakes 為 Jonathan 表演的。只是想問一下，您是否可以提供一些背景信息，說明在即將發布的 ASCO 1100 研究更新中我們應該看到的患者數量、隨訪時長或潛在讀數？

Hi, Jonathan. Thanks for the question. So maybe for the audience, let's maybe recap what is the study and what is the intention here. So that's Study 1100, which is a study that is made to define and absorb safety and efficacy in different population who were treated with radiation therapy, NBTXR3, and checkpoint inhibitor in head and neck cancer.

你好，喬納森。謝謝你的提問。因此，對於觀眾來說，也許我們可以回顧一下這項研究的內容以及其目的是什麼。這就是研究 1100，這是一項旨在定義和吸收接受放射療法、NBTXR3 和檢查點抑制劑治療頭頸癌的不同人群的安全性和有效性的研究。

So maybe before to go into some of the details on what we should expect to see at ASCO, the title abstracts have been released lately. Here, we're talking about patients that had received a certain number of line of treatment, premedicated, which have had radio, chemo, or chemo or surgery followed by radiotherapy; and then after this first line of treatment, experienced a relapse.

因此，在詳細了解 ASCO 上我們應該看到的內容之前，標題摘要最近已經發布了。這裡，我們討論的是已經接受過一定線治療的患者，這些患者在接受藥物治療後，進行了放療、化療，或者化療或手術後進行放療；然後在第一線治療後，病情復發。

And when experiencing this relapse have been eligible to go for PD-1 treatment. So if you want to -- comparator of such a baseline in population, you should look at trials like CheckMate 141 or KEYNOTE 040.

當經歷這種復發時，就有資格接受 PD-1 治療。因此，如果您想比較人群中的基線，您應該查看 CheckMate 141 或 KEYNOTE 040 等試驗。

So in all trial, we have in the current extension phase that is ongoing split in two different cohorts for head and neck patients, the first cohort being patients that are naive to PD-1 and the second call being patients that are refractory to PD-1. So the recruitment have been going very well.

因此，在所有試驗中，我們在目前的擴展階段將頭頸部患者分為兩組，第一組是對 PD-1 未治療過的患者，第二組是對 PD-1 有抵抗力的患者。因此招募進展非常順利。

We expect to have a good number of patients to show both for refractory and naive to PD-1 patient for ASCO. And what we would expect in terms of data is, of course, safety and importantly, the efficacy. And in terms of efficacy, we should look at response rate after [received], also the all target lesion response, and overall survival and PFS.

我們預計在 ASCO 上將有大量患者表現出對 PD-1 有抵抗力和初治能力。就數據而言，我們期望的當然是安全性，更重要的是有效性。在療效方面，我們應該關注治療後的反應率、所有標靶病變的反應、總存活期和 PFS。

So we think that achieving a good number of patient recruitment in this trial will start to really allow us to quantify the potential effect of NBTXR3. And it evolves to amplify the response for naive patients and potentially to reverse the resistance in refactorization to PD-1.

因此，我們認為，在本次試驗中招募大量患者將真正讓我們能夠量化 NBTXR3 的潛在效果。並且它不斷發展以擴大對初治患者的反應並可能逆轉對 PD-1 重塑的抵抗。

Great. Thank you so much.

太好了。非常感謝。

I hope that answered your question.

我希望這回答了你的問題。

Yeah. Appreciate that. Thank you.

是的。非常感謝。謝謝。

You’re welcome.

別客氣。

Lucy Codrington, Jefferies.

露西‧科德林頓，傑富瑞集團。

Hi, there. Thanks for taking my questions. So just a couple of ones for me.

你好呀。感謝您回答我的問題。對我來說只有幾個。

So in terms of the lung cancer trial start that Janssen is planning and then just, I guess, more generally about your relationship with the Anderson, how regularly are you meeting to make these decisions, both about the lung cancer start, but also you mentioned about pancreatic cancer with the -- a registrational strategy for IO combination? When will we get more detail on these next indications beyond head and neck?

那麼，就楊森計劃開始的肺癌試驗而言，我想，更一般地說，關於您與安德森的關係，你們多久開一次會來做出這些決定，既關於肺癌的開始，也關於胰腺癌——IO 組合的註冊策略？我們什麼時候才能獲得有關頭部和頸部以外適應症的更多詳細資訊？

Then secondly, it still relates to the Janssen relationship. What's the visibility on the in-kind funding for NANORAY-312 and the cadence of that? And why -- is that included in your cash runway? And if it isn't, why isn't it? I was under the impression it would be near-term funding.

其次，它仍然與詹森關係有關。NANORAY-312 實物資助的可見性如何？資助節奏如何？為什麼——這包括在你的現金流中？如果不是，為什麼？我以為這會是短期融資。

And then finally, in terms of the mid-2025 readout for NANORAY-312, what's your confidence in that time line? I do appreciate it is event driven. But I guess what's your comfort with your current cash runway? And will it get you to that data?

最後，就 NANORAY-312 的 2025 年中期讀數而言，您對該時間表有何信心？我確實很欣賞它是事件驅動的。但我想知道您對目前的現金流感到滿意嗎？它會提供你這些數據嗎？

And I guess related to that, an update, please, on the recruitment of NANORAY-312. Thank you.

我想與此相關的是，請更新 NANORAY-312 的招募情況。謝謝。

Thank you, Lucy. That's a bunch of questions. Maybe let's start with the relationship with J&J and within the priority and how we've been shaping this collaboration since we signed last summer.

謝謝你，露西。這是一堆問題。也許我們可以先從與強生的關係開始，然後討論優先事項以及自去年夏天簽約以來我們如何塑造這種合作關係。

So altogether, before to going in some details about the question you've been asking, we've been working a lot with J&J in order to shape this collaboration. First of all, establishing the good earnings, then establishing joint team and working team. That, I can tell you, we meet almost on a daily basis to work.

總而言之，在詳細討論您提出的問題之前，我們一直在與強生公司進行大量合作以促成這項合作。首先要建立良好的收益，其次要建立聯合團隊和工作團隊。我可以告訴你，我們幾乎每天都見面上班。

We also have a (inaudible) of priorities that we are moving forward in the 312 and the lung cancer program owned by J&J. So those are the really two priority for the initial development in this program.

我們也（聽不清楚）有一系列優先事項，我們正在推動強生公司的 312 和肺癌計畫。因此，這確實是該計劃初期開發的兩個優先事項。

Something that you don't see, but we've been working a lot also in manufacturing and also exploring potential other indications with the medical team internal at Nano and the J&J team. So there's a lot of underground work in order to share this collaboration. And there's a lot of discussion ongoing to refine the pathway to go to market with R3.

有些東西你看不到，但我們在製造方面也做了很多工作，並且還在與 Nano 內部醫療團隊和強生團隊一起探索潛在的其他適應症。因此，為了分享這種合作，我們需要做大量的地下工作。目前，正在進行大量討論，以完善 R3 進入市場的途徑。

And I can ensure you that in due time, we'll give you a more information when things are being finalized and agreed with our partner. But at the time, we can't say much more on this. But be ensured that we're working with the J&J team on daily basis to shape this development and to try to bring NBTXR3 as fast as we can to the market.

我可以向你保證，當事情最終確定並與我們的合作夥伴達成一致時，我們會及時向你提供更多資訊。但目前我們還不能就此透露更多。但請放心，我們每天都在與強生團隊合作，推動這項發展，並儘快將 NBTXR3 推向市場。

Now that there was a question about when the lung cancer program or trial should start. Well, we can't talk for our partners, but be ensured that they have been working a lot on that and will our help from time to time. And as soon as we can tell you, we will inform you about this very specific and important program.

現在的問題是肺癌計劃或試驗應該何時開始。好吧，我們不能代表我們的合作夥伴發言，但可以肯定的是，他們已經為此付出了很多努力，並且會不時地提供幫助。一旦我們能夠通知您，我們就會告知您有關這個非常具體和重要的計劃。

Now about the in-kind contribution that's been. That's something that was in the contract, as you may notice. It's not in the current runaway definition, but that's something that is also ongoing discussion with J&J on how to have, where to have, and how can we share that.

現在談談實物捐贈。您可能注意到了，這是合約中的內容。它不在當前的失控定義中，但這也是與強生正在進行的討論，討論如何擁有、在哪裡擁有以及如何分享。

Maybe I will let Bart to comment a little on that.

也許我會讓巴特對此發表一些評論。

Yeah, happy to. Thank you for the question, Lucy. So for the audience, this is the in-kind contribution that was agreed upon in the license agreement. And that is in-kind support that will directly be funded by J&J from their own P&L.

是的，很高興。謝謝你的提問，露西。因此對觀眾來說，這是許可協議中同意的實物貢獻。這是實物支持，將由強生公司從自己的損益表中直接資助。

So it will not flow through our P&L. Therefore, it doesn't influence our cash runway. However, it helps to accelerate the ongoing 312 study.

所以它不會流入我們的損益表。因此，它不會影響我們的現金流。然而，它有助於加速正在進行的 312 研究。

So now for the interim analysis of the 312. So as the previous guidance we've given, we continue to expect to have the right number of events by ‘25 to be able to do this readout. And as you may have noticed in our financial statements that we have money up to -- or into Q3 2025.

現在對 312 進行中期分析。因此，根據我們先前給予的指導，我們仍然預計到 2025 年會有正確數量的事件，以便能夠進行此讀數。您可能已經在我們的財務報表中註意到，我們的資金可用到 2025 年第三季。

So maybe I will leave Bart to refine or give some context about the financing moving forward.

因此，也許我會讓巴特來完善或提供一些有關未來融資的背景資訊。

Yeah, happy to, Laurent. Yes, the cash runway into Q3 of ‘25 further to the guidance that has been provided previously with regards to the interim, that continues to be our expectation. And as you may expect in the license agreement that we've concluded with J&J, there is a significant number milestones.

是的，很高興，洛朗。是的，2025 年第三季的現金流將進一步符合先前針對中期業績提供的指導，這仍然是我們的預期。正如您可能預料的那樣，我們與強生公司達成的授權協議中有許多里程碑。

So milestones are typically payable at key inflection points. And without being able to share anything more, one could expect that at significant moments in time, that would trigger payments in order to sustain and refinance the company going forward. That's all that I can share at this point in time, but I hope that that provides clarity.

因此里程碑通常在關鍵轉折點支付。雖然無法分享更多信息，但人們可以預期，在重要時刻，這將觸發付款，以維持和再融資公司的未來發展。這就是我目前能分享的全部內容，但我希望這能提供清晰的解釋。

So Lucy, I hope this answer your questions. Would love to more (technical difficulty)

所以露西，我希望這能回答你的問題。很想了解更多（技術難度）

That was very --

那非常--

Yes, please go ahead.

是的，請繼續。

Sorry, very helpful. Just to clarify on that last milestone thing. So the -- other than the $20 million you've already included, those potential significant number of milestones, some of those could come before the mid-‘25 readout to extend that beyond -- comfortably beyond the data.

抱歉，非常有幫助。只是為了澄清最後一個里程碑的事情。因此，除了您已經提到的 2000 萬美元之外，那些潛在的重要里程碑，其中一些可能會在 2025 年中期讀數之前實現，從而將其延伸到數據之外。

As you know, we're not at the liberty to disclose the sequence of the milestones, either the events or the quantum that are into it. But I think from a logical perspective, we should assume that some of those milestones may come when some of the derisking events or validating event will occur.

如您所知，我們無權透露里程碑的順序，無論是其中的事件還是量子。但我認為從邏輯角度來看，我們應該假設其中一些里程碑可能會在某些降低風險事件或驗證事件發生時到來。

And as we did mention in the past, there is a good proportion of this milestone at least for the initial program following to head and neck and lung program. So not being to tell you more, I think we would anticipate a number of milestone over time linked to this program.

正如我們過去提到的那樣，至少對於頭頸和肺部項目之後的初始項目來說，這一里程碑佔了很大一部分。因此，我不會告訴你更多，但我認為我們會預期隨著時間的推移與該計劃相關的許多里程碑。

Okay. Thank you.

好的。謝謝。

Swayampakula Ramakanth, H.C. Wainwright.

拉瑪坎特 (Swayampakula Ramakanth)，H.C. 溫賴特。

Thank you. This is RK from H.C. Wainwright. Good afternoon, Laurent and Bart. A couple of questions, but they are related within the NANORAY-312 program.

謝謝。這是來自 H.C. Wainwright 的 RK。下午好，Laurent 和 Bart。有幾個問題，但它們與 NANORAY-312 計劃有關。

So the first question is since you will be taking a couple of looks into the data, one for futility analysis and another for the interim safety and efficacy look on the pre plan, 67% of PFS event, would they -- and because you also stated that depending on how strong the data is, you could file for an accelerated approval.

因此，第一個問題是，由於您將對數據進行幾次查看，一次用於無效性分析，另一次用於中期安全性和有效性分析，那麼在計劃前，PFS 事件的發生率為 67%，他們會嗎？而且因為您也表示，根據數據的強度，您可以申請加速批准。

My question basically is, would this impact the offer in terms of statistical calculation when you're doing multiple looks before you -- before you see the interim data, especially for significance to file for an accelerated approval?

我的問題基本上是，在您看到中期數據之前進行多次查看時，這是否會影響統計計算方面的報價，尤其是對於申請加速批准的意義？

Thanks, RK. Yes, if we look at the design of this trial, there is a multiple number of events for the facility than the interim readout and the final readout of the data. There's the primary endpoint being PFS and the secondary OS.

謝謝，RK。是的，如果我們看一下這次試驗的設計，就會發現該設施的事件數量比數據的中期讀數和最終讀數多得多。主要終點是 PFS，次要終點是 OS。

And as mentioned, there is a certain number of events that will trigger those readouts. And as per design of the protocol, those multiple loop will have an influence on the alpha. And also, when we have been designing this trial, we have been powering this trial to be good for OS and, therefore, has been overpowered for the PFS.

如同前面所提到的，一定數量的事件會觸發這些讀數。並且根據協議的設計，這些多重循環將對 alpha 產生影響。而且，當我們設計這個試驗時，我們一直在為這個試驗提供動力，使其對 OS 有利，因此，對 PFS 的動力就更大了。

But all in all, this obviously have been taken into account in the number of patients we need to work with in order to get to the positive statistical benefits that we intend in this trial. RK, if you want to add a bit more detailed discussion, I think we can hand over the clinical trial data protocol and have a more precise discussion on this. We'll be happy to -- we can have a call with our CMO for that regard.

但總而言之，為了在本次試驗中獲得我們想要的積極統計效益，我們在計算需要治療的患者數量時顯然已經考慮到了這一點。RK，如果您想進行更詳細的討論，我認為我們可以交出臨床試驗數據協議並對此進行更精確的討論。我們很樂意－我們可以就此與我們的行銷長通話。

Certainly, certainly. We can take that offline. I just wanted to -- at a high level, I just wanted to check on that.

當然，當然。我們可以將其離線。我只是想——從高層次上來說，我只是想檢查一下這一點。

And then the second question is on -- obviously, beyond what we are talking today, you have multiple studies ongoing with MD Anderson. And I think I've asked this question multiple times, but -- so what is the appetite for Janssen in terms of picking up these other indications, whether it's (inaudible) the other solid tumors like pancreatic? What do you think is their appetite going beyond what they're doing now?

第二個問題是——顯然，除了我們今天討論的內容之外，您還與 MD Anderson 合作進行了多項研究。我想我已經問過這個問題了，但是——那麼，楊森在選擇這些其他適應症方面有什麼興趣，無論是（聽不清楚）其他實體瘤，如胰腺癌？您認為他們的興趣會超越現在所做的事情嗎？

Okay. So first, maybe let's remind the context of MDA collaboration and how it does fit with the J&J licensing out. So in the Janssen licensing out, that's a full licensing out, worldwide now, that they have taken back the rights from the Nanobio for development and commercialization of NBTXR3. So we have a relationship between Nanobiotix and J&J on that matter.

好的。因此，首先，讓我們回顧一下 MDA 合作的背景以及它與 J&J 許可證的契合程度。因此，在 Janssen 授權中，這是一個全球性的全面授權，他們已經從 Nanobio 收回了開發和商業化 NBTXR3 的權利。因此，在這個問題上，Nanobiotix 和強生公司之間存在著合作關係。

We still have a collaboration with MD Anderson which is compatible with this alliance with J&J. And so it's two different collaborations, one with MD Anderson and one with J&J. Nevertheless, we're all developing the same product with the same intention to try to maximize the impact for the patients.

我們仍然與 MD Anderson 保持著合作關係，這與與強生公司的聯盟相容。這是兩種不同的合作，一種是與 MD Anderson 的合作，另一種是與 J&J 的合作。儘管如此，我們都在開發相同的產品，並懷抱著相同的意圖，試圖最大限度地為患者帶來益處。

Let's say that if I look at how this pleated in terms of periods of activity -- for sure, when you think about a big company like J&J, their intention is to run some pivotal and randomized trial in order to get to market and start in preparing commercialization and so on within standard of care or outside.

假設我從活動週期的角度來看一下這種情況——當然，當你想到像強生這樣的大公司時，他們的目的是進行一些關鍵的隨機試驗，以便進入市場並開始準備商業化等等，無論是在護理標準之內還是之外。

For MD Anderson, the spirit of the collaboration is more about how can we prove bundle of medicine using NBTXR3 not only in the existing standard of care with radiation as a whole, but potentially beyond that. So I see the MDA collaboration more as a pushing the boundaries collaboration and also trying to find some signal in term of efficacy that could help us to define future development.

對 MD Anderson 來說，合作的精神更多的在於我們如何證明使用 NBTXR3 的藥物組合不僅在現有的放射治療標準中，而且可能超越這一點。因此，我認為 MDA 合作更像是一種突破界限的合作，同時也試圖在功效方面找到一些訊號，以幫助我們確定未來的發展。

So there's no three-partied relationship in these two collaborations, but there is medical and scientific exchanges in order to make sure that what we do one way or the other is compatible.

因此，這兩項合作中不存在三方關係，但存在醫學和科學交流，以確保我們所做的事情是相容的。

Now as I mentioned just previously in the call, part of the discussion with the Interventional Oncology Group is about, okay, how and what could happen, where we could go after [learned] in head and neck. We had a little discussion around that.

正如我之前在電話中提到的，與介入性腫瘤學小組討論的部分內容是關於如何以及會發生什麼，以及在頭頸部腫瘤治療後我們可以去哪裡。我們對此進行了一些討論。

And definitely, what we do at MD Anderson is part of the information we use to inform that discussion. Unfortunately, I can’t tell you more right now even if there is a lot of discussion around all those matters.

毫無疑問，我們在 MD Anderson 所做的工作是我們用來進行討論的訊息的一部分。不幸的是，儘管圍繞這些問題有很多討論，但我現在無法告訴你更多。

Thank you. Thank you, Laurent, for taking my question and talk to you soon.

謝謝。謝謝 Laurent 回答我的問題，我們很快就會再聊。

Thank you, RK.

謝謝你，RK。

Clemence Thiers, Stifel.

克萊門斯·蒂耶爾，Stifel。

Hi. Thanks for taking my question. I'm stepping a bit away from the presentation, but I had a couple of questions regarding your (inaudible) and equity platform, which you unveiled this year. Can you give us more colors on your activities there, maybe at what stage of development you are? Is there any chance to see a candidate in clinic this year?

你好。感謝您回答我的問題。我離演講還有一點距離，但我對您今年推出的（聽不清楚）和公平平台有幾個問題。您能否向我們詳細介紹您在那裡的活動，以及目前處於哪個發展階段？今年有機會在診所見到候選人嗎？

And regarding (inaudible) in particular, you had a collaboration with Sanofi back in 2021 for gene therapy. Could you maybe tell us, if it's still ongoing, where you are now? And finally, still on this, are there any discussions ongoing with J&J about this platform? Thanks.

特別是關於（聽不清楚），您早在 2021 年就與賽諾菲合作進行基因治療。如果它仍在進行中，您能否告訴我們您現在在哪裡？最後，關於這個平台，是否正在與強生公司進行任何討論？謝謝。

Thank you, Clemence. So as you mentioned, the two other technology platform we have at Nanobiotix. Maybe first to dig in and to just briefly explain what it is, I just want to remind the philosophy in which we've been developing those three platforms.

謝謝你，克萊門斯。正如您所提到的，Nanobiotix 擁有另外兩個技術平台。也許首先要深入研究並簡要解釋一下它是什麼，我只是想提醒一下我們開發這三個平台的理念。

So for Nanobiotix, the motive since we've created this company has been to try to find products or platform products that could help millions of patients and also, on the top of that, to have a product or a platform that will be new. Meaning we want to be the first one to develop what we are looking at at Nanobiotix. And the latest one is that we want that to be broadly protected by intellectual property.

因此，對於 Nanobiotix 來說，自從我們創建這家公司以來，我們的動機就是嘗試尋找能夠幫助數百萬患者的產品或平台產品，最重要的是，擁有一個全新的產品或平台。這意味著我們希望成為第一個開發我們在 Nanobiotix 上研究的東西的人。最新的舉措是，我們希望透過智慧財產權來廣泛保護這一點。

So far, we've been able to do that. And for the three different platform that potentially will generate multiple first-in-class product, widely protected with IP. So we've been using this, and I've been able to develop that because we use nanophysics as a fundamental prerequisite to our different products.

到目前為止，我們已經能夠做到這一點。這三個不同的平台可能會產生多個一流的產品，並受到廣泛的智慧財產權保護。因此我們一直在使用它，並且我能夠開發它，因為我們將奈米物理學作為我們不同產品的基本先決條件。

Why? Because we think when you use physics, then you have much less viability induced by biology. And therefore, you can start imagining products that could help a lot of patients. So that's why we've been using nanophysics instead biology or chemistry so far.

為什麼？因為我們認為，當你使用物理學時，生物學所帶來的生存能力就會大大降低。因此，您可以開始想像可以幫助許多患者的產品。這就是為什麼我們迄今為止一直使用奈米物理學而不是生物學或化學。

So now within this context, we've been developing the first platform, which is a radioenhancer platform that you know, and two other platforms, one which is linked to CNS disorder. And that's -- the name that was mentioned at (inaudible) this platform is about looking at the brand more as an electric circuit rather than looking at the brand as a biological organ.

因此，現在在這種背景下，我們一直在開發第一個平台，這是一個放射增強器平台，以及另外兩個平台，其中一個與中樞神經系統疾病有關。這就是——（聽不清楚）這個平台上提到的名稱是將品牌視為電路，而不是將品牌視為生物器官。

And when you start to looking at degenerative disease in the brain or in peripheral system, you can look and see that most of the deficiencies become or expressed through a misconnection between your own or that conviction that is too fast or too slow or (inaudible) so we've been developing a number of nanoparticles that have the ability to change the way electricity is conducted. And this is at the neuron level.

當你開始研究大腦或周圍系統的退化性疾病時，你會發現大多數缺陷都是透過你自己的錯誤連接或太快或太慢或（聽不清楚）的信念而產生的，所以我們一直在開發一些能夠改變電流傳導方式的奈米粒子。這是在神經元層面。

So you can imagine that if we can have this particle in contact, like on the surface, inside or outside the neuron, we will change the way electric conduction is done within neuron or between neuron. So this is just the fundamental of this technology platform that potentially will lead to multiple products. And that's the less advanced platform and also not the current focus for Nanobiotix.

所以你可以想像，如果我們可以讓這個粒子接觸到神經元，例如在神經元的表面、內部或外部，我們就會改變神經元內部或神經元之間的電傳導方式。這只是該技術平台的基礎，可能會產生多種產品。這是一個不太先進的平台，也不是 Nanobiotix 目前的重點。

So you did mention (inaudible) which is [here again], a different approach, where we've been looking at why so many products cannot be delivered the right way. Or how -- why are we limited in terms of efficacy or safety?

所以你確實提到了（聽不清楚），這是一種不同的方法，我們一直在研究為什麼這麼多產品無法以正確的方式交付。或者為什麼我們的功效或安全性受到限制？

And I can take for example like the drug delivery systems that have been used to deliver (inaudible) irinotecan and some others. There will also be RNX-based LNP that faced a number of problems when we deliver IV or oncolytic virus on some other technology or approaches.

我可以舉個例子，例如用於輸送（聽不清楚）伊立替康和其他藥物的藥物輸送系統。當我們透過其他技術或方法輸送靜脈注射或溶瘤病毒時，基於 RNX 的 LNP 也會面臨許多問題。

What makes a link between all the technology I've been mentioning is when you inject that IV, the liver will act as a strength feature and will capture the vast majority of this product and will not allow those products to go outside in the body. Therefore, we're limited by the way you can deliver. And that's why people are delivering oncolytic virus most of the time directly where they want it to be, just like the LNP with RNA product.

我所提到的所有技術之間的關聯在於，當你注射靜脈注射時，肝臟將發揮強度功能，捕獲絕大多數產品，並且不會讓這些產品排出體外。因此，我們受到您交付方式的限制。這就是為什麼人們大多數時候將溶瘤病毒直接運送到他們想要的地方，就像帶有 RNA 產品的 LNP 一樣。

So looking at this, we thought that -- can we rethink the way products are delivered? And can we change this? Can we do it differently? That's what led us to develop what we call the Nanoprimer, which is a nanoparticle that you inject IV.

因此，考慮到這一點，我們認為──我們能否重新思考產品的交付方式？我們能改變這種狀況嗎？我們能做不同的事嗎？這促使我們開發出所謂的 Nanoprimer，它是一種可以透過靜脈注射的奈米粒子。

And this particle will go in the liver as many other particles, but it has been designed in a very specific way. So this particle will be sort of digested by the liver for a certain amount of time. And while the liver is busy digesting this particle, when you inject other type of products, they will go more freely through the liver. And therefore, you change completely the biodistribution of this product.

這種粒子會像許多其他粒子一樣進入肝臟，但它的設計方式非常特殊。因此，這種顆粒會在一定時間內被肝臟消化。當肝臟忙於消化這種顆粒時，當您注射其他類型的產品時，它們將更自由地通過肝臟。因此，您完全改變了該產品的生物分佈。

And more than changing things, you can allow to do things in this Nanoprimer that you will not be allowed to do without. If I take RNA delivery particle as an example, very hard when you inject IV to go and target or other -- like brain or lungs or other type of organs. And with Nanoprimer -- and we've been looking at different animal model -- we are able to do that.

除了改變事物之外，您還可以在此 Nanoprimer 中執行一些您無法執行的操作。如果我以 RNA 傳遞顆粒為例，當你透過靜脈注射到達目標或其他器官（如大腦、肺或其他類型的器官）時，會非常困難。利用 Nanoprimer——我們一直在研究不同的動物模型——我們能夠做到這一點。

So there's a lot to do with this platform, as you can imagine, given the potential and the different approaches we could use both in terms of product impact, but also in terms of therapeutic areas. But a big part of the ongoing program internally is about defining the business model, defining how we're going to move forward in different aspects of this product. And we expect to give an update on that before the end of this year.

因此，正如您所想像的，考慮到我們在產品影響方面以及治療領域方面可以採用的潛力和不同方法，這個平台有很多用途。但內部正在進行的計劃很大一部分是定義商業模式，定義我們如何在該產品的不同方面取得進展。我們預計在今年年底前公佈最新進展。

So we are talking about the stage of development. So it’s a clinical stage development, but we already have established a good number of proof of concepts on different type of products. Now, it's all about how we are going to bring that to people, to patients, and how we're going to bring that to market.

所以我們正在談論發展階段。因此，這是一個臨床階段的開發，但我們已經在不同類型的產品上建立了大量概念驗證。現在，關鍵在於我們如何將其帶給人們、帶給患者，以及如何將其推向市場。

And even the potential of this platform on so many fronts, I think this will allow us for different type of business model ranging from licensing out to in-house development for different products. But as I said, we will tell you more before the year ends on this matter.

而且這個平台在許多方面都具有潛力，我認為這將使我們能夠採用不同類型的商業模式，從授權到不同產品的內部開發。但正如我所說，我們將在今年年底前告訴大家有關此事的更多資訊。

Now you mentioned a collaboration with Sanofi that we've been establishing to try to assess this platform with different types of therapies they have internally. So the collaboration went out well. We've been establishing some good data.

現在您提到了與賽諾菲的合作，我們一直在嘗試透過他們內部的不同類型的療法來評估這個平台。所以合作進行得很順利。我們已經建立了一些良好的數據。

Now, the next steps and the potential side will be to explore further. But this obviously within the bigger context of establishing the right business model for the company with this platform.

現在，下一步和潛在的方面將是進一步探索。但這顯然是在利用該平台為公司建立正確的商業模式的大背景下的。

Okay. Thank you very much. And did you discuss it with J&J or are they only focused on R3?

好的。非常感謝。您是否與強生公司討論過此事，還是他們只專注於 R3？

No. For now, we don’t -- we haven't been discussing with J&J about other technology platform. We're really focusing on the development of NBTXR3, as is the vast majority of our team.

不。目前，我們還沒有與強生公司討論其他技術平台。我們和團隊中的絕大多數成員一樣，真正專注於 NBTXR3 的開發。

Okay, makes sense. Thank you very much.

好的，有道理。非常感謝。

Colin Bristow, UBS.

瑞銀集團的柯林布里斯托。

Hi, this is Elliott Bosco on for Colin Bristow. A few questions for me. You recently shared the recommended Phase 2 dose in inoperable lung cancer. I know that study was led by MD Anderson, but is there anything you can say on our next steps? And then on the initial Phase 1b/2 esophageal cancer readout that you're expecting, are you able to share what might be expected in the readout and what you see as the threshold for success? Thank you.

大家好，我是 Elliott Bosco，代替 Colin Bristow。我有幾個問題。您最近分享了針對無法手術的肺癌的建議第 2 期劑量。我知道這項研究是由 MD Anderson 領導的，但您能透露一下我們下一步的計劃嗎？然後，根據您預期的初始 1b/2 期食道癌讀數，您能否分享讀數中可能出現的結果以及您認為成功的門檻是什麼？謝謝。

Thank you for the question. So as you know, we have a number of clinical trials ongoing done by and at MD Anderson. We've been, in the recent past, delivering two good news coming from this trial, the one on pancreatic cancer that we've been summarizing during the first part of the call with potential good data coming in. And this trial now is getting close to completion, and we may expect to get additional data on this pancreatic cancer trial.

謝謝你的提問。如您所知，我們正在 MD Anderson 進行多項臨床試驗。最近，我們一直在傳遞來自這次試驗的兩個好消息，一個是關於胰腺癌的消息，我們在電話會議的第一部分已經進行了總結，並獲得了潛在的良好數據。現在這項試驗已接近完成，我們有望獲得有關這項胰臟癌試驗的更多數據。

Rightly, you've mentioned that we reached the RP2D in lung cancer trial -- in one of the lung cancer trial of MDA just to [precise] the context of this lung cancer trial. As you know, radiation therapy is widely used in the lung cancer for different stage of the disease.

正確地說，您提到我們在肺癌試驗中達到了 RP2D——在 MDA 的一項肺癌試驗中，只是為了[精確]這項肺癌試驗的背景。眾所周知，放射療法廣泛應用於不同階段的肺癌治療。

Here at NDA, it was a very particular trial, where we wanted to help patients that already received radiation and relapsed or did not respond well enough to radiation and had a local relapse within the field of previously radiated tissue. The goal here being the following.

在 NDA，這是一項非常特別的試驗，我們希望幫助那些已經接受放射治療並復發或對放射治療反應不佳並在先前接受放射治療的組織範圍內出現局部復發的患者。這裡的目標如下。

You can't reapply in a pre-radiated tissue a full dose of irradiated radiation without risking damaging too much the tissue of the patients. So the idea of this trial was, first, is it feasible to re-radiate in the lung area safely? And two, does it provide benefits if we put R3 on the top of radiation with the lower dose of radiation than the total dose will be for a [diuretic] effect?

您無法在預先輻射過的組織中重新施加全劑量的輻射，否則可能會對患者的組織造成過多的損害。因此，這次試驗的想法是，首先，在肺部區域進行再次放射治療是否可行？其次，如果我們將 R3 置於放射線之上，且放射線劑量低於總劑量以達到 [利尿] 效果，這是否會帶來好處？

So we have studied the RP2D, have expanded into the expansion phase, and the recruitment is moving well. And again, we [are lacking] pancreatic, we should be able, hopefully soon, to give an update on this trial, including more patients than what would be presented both on pancreatic and lung.

因此，我們研究了 RP2D，並已進入擴展階段，招募工作進展順利。再說一次，我們[缺乏]胰腺，我們應該能夠，希望很快，提供關於這個試驗的最新情況，包括比胰腺和肺部所呈現的更多的患者。

But as you know, MDA is the sponsor of the trial. So at the end of the day, we're still depending on when and how to communicate the data even though there is a joint steering committee and this collaboration works really well.

但正如您所知，MDA 是該試驗的贊助商。因此，儘管有一個聯合指導委員會並且這種合作進展順利，但我們最終取決於何時以及如何傳達數據。

So now for the esophageal cancer, that's a different type of approach. We're talking about patients having esophageal cancer that cannot be removed surgically. And here, having a good local control is also very important for the potential improvement of survival of the patient, quality of life, and, in some case, if we can get to a surgery that could remove the primary tumor.

因此，對於食道癌來說，這是一種不同的治療方法。我們討論的是患有食道癌且無法透過手術切除的患者。在這裡，良好的局部控制對於患者存活率和生活品質的潛在改善也非常重要，在某些情況下，如果我們能夠進行手術切除原發腫瘤。

So the trials were put in, and we're discussing about potential reshaping of that with MD Anderson. And we don't have the exact timing for now on when this should happen and when it should be able to give you the data. But as I said when I look at esophageal, pancreatic, lung cancer, it is moving and we should expect some update coming in the coming quarters.

因此，試驗已經啟動，我們正在與 MD Anderson 討論可能的重塑。目前我們還不知道這件事何時會發生，以及何時能夠提供你數據。但正如我所說的，當我觀察食道癌、胰腺癌和肺癌時，它正在發展，我們應該期待在未來幾季會出現一些更新。

Thank you. And there are no further questions at this time. I would like to turn it back to Laurent Levy for closing remarks.

謝謝。目前沒有其他問題。我想請 Laurent Levy 做最後發言。

Thank you. So I would like to thank everyone for participating to this call. And be ensured that we will keep you updated as soon as we are moving forward in some of the developments we've been explaining today.

謝謝。因此，我要感謝大家參加這次電話會議。請放心，一旦我們今天解釋的一些進展取得進展，我們將立即向您通報最新情況。

And I would like to personally thank you for all the support you've been [addressing] during the past year and decade in helping us to have millions of patients with our different technology platform. And I hope to talk to you soon. I wish you a great day.

我個人也想感謝你們在過去一年和十年中給予我們的所有支持，幫助我們透過不同的技術平台服務數百萬患者。我希望很快能和你交談。祝您有個愉快的一天。

Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

謝謝各位主持人。女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。