Nanobiotix SA (NBTX) 2022 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Nanobiotix business update and full-year 2022 financial results conference call.

美好的一天，謝謝你的支持。歡迎來到 Nanobiotix 業務更新和 2022 年全年財務業績電話會議。

A slide presentation accompanying this call can be found at the Investors section of the company's website at www.nanobiotix.com. (Operator Instructions) Please be advised that today's conference is being recorded.

可在公司網站 www.nanobiotix.com 的投資者部分找到本次電話會議的幻燈片演示。 （操作員說明）請注意，今天的會議正在錄製中。

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

在這一點上，我將把電話轉給 Nanobiotix 投資者關係高級副總裁 Craig West。

Thank you, operator. Good afternoon, and good morning. And welcome to the Nanobiotix conference call to discuss our full-year 2022 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.

謝謝你，運營商。下午好，早上好。歡迎參加 Nanobiotix 電話會議，討論我們 2022 年全年的財務和經營業績。今天和我一起參加電話會議的是聯合創始人兼首席執行官 Laurent Levy；和首席財務官 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絡直播，並將在我們的網站上進行重播。我想提醒您，本次電話會議將包括前瞻性陳述，其中可能包括關於我們正在進行和計劃進行的臨床試驗、合作、監管文件、演示日期和未來研發的進展、成功和時間安排的陳述除其他事項外的努力。

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可能發生變化的當前信息、假設和預期。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存在重大差異。因此，請注意不要過分依賴前瞻性陳述。

Please review the full description of risk factors that can be found in the documents we filed with the AMF in France and the SEC in the United States, including the URD and 20-F filed yesterday, both of 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.

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，包括昨天提交的 URD 和 20-F，兩者均可在“投資者關係”部分找到我們的網站，以及昨天發布的新聞稿，重點介紹了我們在此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日的觀點，不應被視為代表我們截至任何後續日期的觀點。雖然我們可能會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。

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

話雖如此，我想把電話轉給洛朗。請繼續。

Thank you, Craig. I would like to welcome everyone participating via conference call and webcast today. I would also like to welcome Craig to his first Nanobiotix conference call as he recently joined us as our new Head of IR. If you haven't already met him, I'm sure there will be opportunity to do so soon.

謝謝你，克雷格。我想歡迎今天通過電話會議和網絡廣播參與的所有人。我還要歡迎 Craig 參加他的第一次 Nanobiotix 電話會議，因為他最近加入我們，成為我們的新 IR 負責人。如果您還沒有見過他，我相信很快就會有機會見到他。

As Craig mentioned, we issued a press release yesterday highlighting the company's full year's operating activity and financial results for 2022. For today's call, I would like to begin by providing an overview of our accomplishments and review upcoming milestones for each of our program before turning the call over to Bart to address financials results, after, we will open the call for your questions.

正如 Craig 提到的，我們昨天發布了一份新聞稿，重點介紹了公司全年的運營活動和 2022 年的財務業績。對於今天的電話會議，我想首先概述我們的成就，並回顧我們每個計劃即將到來的里程碑，然後再轉向打電話給 Bart 來解決財務結果，之後，我們將打開電話詢問您的問題。

Each year, since initiating development of our lead candidate NBTXR3, we have seen evidence continue to mount suggesting NBTXR3 has the potential to change the way solid tumors are treated and improve outcomes for patients. This past year, not only we saw this trend continue but also provided an opportunity to showcase the strength and agility of Nanobiotix's team and its partner, along with the commitment and support of our investigator, researcher, and most importantly, patient, who have continued to support our efforts.

自從開始開發我們的主要候選藥物 NBTXR3 以來，我們每年都看到越來越多的證據表明 NBTXR3 有可能改變實體瘤的治療方式並改善患者的預後。在過去的一年裡，我們不僅看到了這一趨勢的繼續，而且還提供了一個機會來展示 Nanobiotix 團隊及其合作夥伴的實力和敏捷性，以及我們的調查員、研究人員，最重要的是患者的承諾和支持，他們繼續支持我們的努力。

Against the backdrop of geopolitical unrest, the ongoing pandemic, and continued volatility in the capital market, the team remained focused on our mission and adapted to circumstances to successfully first initiate NANORAY-312, our global Phase 3 trial in head and neck cancer in the US, Asia, and Europe, complete enrollment in Study 102, also in head and neck, generate new compelling data from our IO combination program, and early, but very encouraging data on pancreatic cancer, and significantly reduce our operating expenses, secure future access to capital through an equity line, and restructure of debt obligations.

在地緣政治動盪、持續的大流行病和資本市場持續動蕩的背景下，團隊仍然專注於我們的使命並適應環境，成功地首先啟動了 NANORAY-312，這是我們在美國進行的頭頸癌全球 3 期試驗美國、亞洲和歐洲，完成 Study 102 的註冊，包括頭頸部研究，從我們的 IO 組合計劃中產生新的令人信服的數據，以及早期但非常令人鼓舞的胰腺癌數據，並顯著降低我們的運營費用，確保未來的訪問通過股權額度獲得資本，並重組債務義務。

As these achievements suggest the capability and commitment of our team, as critical to our success has is the promise of NBTXR3. It is further testament to both that during the challenges of 2022, we continued to attract new talent to join our mission to improve the lives of cancer patients through the development of NBTXR3.

由於這些成就表明了我們團隊的能力和承諾，對我們成功至關重要的是 NBTXR3 的承諾。這進一步證明，在 2022 年的挑戰中，我們繼續吸引新的人才加入我們的使命，通過開發 NBTXR3 改善癌症患者的生活。

This started early in the year when we strengthened our executive leadership team with the appointment of Dr. Leonard Farber as Chief Clinical and Medical Affairs Officer, who brings significant clinical experience and strong networks of peers committed to improve outcome for patients battling cancer. His insights and expertise are supported by our scientific advisory board, comprised of leading global radiation, medical, and surgical oncologists involved in oncology treatment decision making, clinical trial investigation, and patient recruitment.

這始於今年年初，當時我們任命 Leonard Farber 博士為首席臨床和醫療事務官，加強了我們的行政領導團隊，他帶來了豐富的臨床經驗和強大的同行網絡，致力於改善癌症患者的預後。他的見解和專業知識得到了我們科學顧問委員會的支持，該委員會由參與腫瘤治療決策、臨床試驗調查和患者招募的全球領先的放射、內科和外科腫瘤學家組成。

Looking ahead, we are excited to share that we are expecting a new Chief Medical Officer with extensive development expertise in oncology and immunotherapy to join the Nano team in the third quarter of 2023. This anticipated addition is coupled with the expected arrival of a new head of regulatory scheduled to join the team later in Q2. We believe this addition will strengthen our clinical development program, better position us for registration, and help optimize our pipeline development. We look forward to working with this industry expert to help guide late-stage development of our product NBTXR3.

展望未來，我們很高興地與大家分享，我們期待一位在腫瘤學和免疫療法方面具有廣泛開發專業知識的新首席醫療官將於 2023 年第三季度加入 Nano 團隊。這一預期的增加與新負責人的預期到來相結合監管部門計劃在第二季度晚些時候加入該團隊。我們相信，此次加入將加強我們的臨床開發計劃，更好地定位我們的註冊，並幫助優化我們的管道開發。我們期待與這位行業專家合作，幫助指導我們產品 NBTXR3 的後期開發。

As you know, we started 2022 with the randomization of our first patient in NANORAY-312, our global Phase 3 registrational study for patients with locally advanced head and neck cancer that are ineligible for platinum-based chemotherapy. This milestone set the tone for the year, and the team focused on driving the rollout of this study and initiation of sites across the globe.

如您所知，我們從 2022 年開始對 NANORAY-312 中的第一位患者進行了隨機分組，這是我們針對不符合鉑類化療條件的局部晚期頭頸癌患者的全球 3 期註冊研究。這一里程碑為今年定下了基調，團隊專注於推動這項研究的推出和全球站點的啟動。

The diligence and execution supported by our partner, LianBio, have resulted in the activation of over 104 sites in 25 countries across core geographical sites in Europe, Asia, and United States as of year-end. I'm particularly pleased to be able to tell you that the team managed to accomplish this in just over a year in a challenging environment due to several factors, such as competitive clinical trial and difficulties of a post-COVID world.

截至年底，在我們的合作夥伴 LianBio 的努力和執行支持下，已在歐洲、亞洲和美國的核心地理區域的 25 個國家/地區激活了超過 104 個站點。我特別高興地告訴大家，由於競爭激烈的臨床試驗和後 COVID 世界的困難等多種因素，該團隊在充滿挑戰的環境中僅用了一年多的時間就完成了這項工作。

Despite these achievements and continued progress, I will note that enrollment across country generally has been slower than initially anticipated, and we primarily attribute this to the complex and changing regulatory framework across EU, the continued impact of the COVID-19 pandemic, particularly in the US, which has led to longer than anticipated contract approval and site initiation due to limited site staffing. And similarly, in Asia, COVID protection measure and, originally, lockdowns that persisted intermittently through 2022. And finally, we had to replace the Ukrainian and Russian sites that were originally selected.

儘管取得了這些成就並持續取得進展，但我要指出，全國的入學率普遍低於最初預期，我們主要將其歸因於整個歐盟複雜多變的監管框架、COVID-19 大流行的持續影響，尤其是在美國，由於現場人員配備有限，導致合同批准和現場啟動的時間比預期的要長。同樣，在亞洲，COVID 保護措施和最初的封鎖斷斷續續地持續到 2022 年。最後，我們不得不更換最初選擇的烏克蘭和俄羅斯網站。

Since the initiation of NANORAY-312, we've been monitoring progress closely and have implemented several measures to increase the efficiency and speed of the trial rollout. The primary focus in 2022 was to increase sites and countries and to decrease the time between regional regulatory approval, contracting, and site activation. This has included increasing both virtual and in-person support for the clinical operation and medical affairs team, both before and after site initiation, to improve site engagement and increase support for key members of the site study team.

自 NANORAY-312 啟動以來，我們一直在密切關注進展情況，並採取了多項措施來提高試驗推出的效率和速度。 2022 年的主要重點是增加站點和國家，並縮短區域監管批准、簽約和站點激活之間的時間。這包括在站點啟動之前和之後增加對臨床操作和醫療事務團隊的虛擬和麵對面支持，以提高站點參與度並增加對站點研究團隊主要成員的支持。

While the longer than anticipated regulatory and site activation process has resulted in a shift in the early enrollment, we are confident that with most regional regulatory approval complete or in the final stage, we can move quickly to onboard the remaining target site plan for NANORAY-312. And reassured by the uptick in the enrollment, we are seeing following the addition of new site and the implementation of our [high-touch] clinical operation engagement strategy.

雖然比預期更長的監管和站點激活過程導致了早期註冊的轉變，但我們相信，隨著大多數地區監管批准的完成或進入最後階段，我們可以迅速採取行動，為 NANORAY 制定剩餘的目標站點計劃- 312.並且由於註冊人數的增加而感到放心，我們看到在增加新站點和實施我們的 [高接觸] 臨床操作參與策略之後。

We expect continued progress in adding sites and seeing the recently added site initiate enrollments. Further, through the increasingly close partnership with investigator fostered by this effort, we identified a new factor that could facilitate patient enrollment and, as a result, are close to the finalization of the minor protocol amendment to clarify and ease the inclusion criteria and simplify patient identification, screening, and enrollment without changing the overall target patient population.

我們期待在添加站點方面繼續取得進展，並看到最近添加的站點啟動註冊。此外，通過這項努力培養的與研究者日益密切的伙伴關係，我們確定了一個可以促進患者入組的新因素，因此，接近完成次要方案修正案，以澄清和簡化納入標準並簡化患者在不改變總體目標患者人群的情況下進行識別、篩查和登記。

As we are ramping up our global registration study in 2022, we are also nearing completion of the Study 102. As a reminder, Study 102 is a dose escalation and expansion study in a similar head and neck cancer population that continues to demonstrate promising activity and was a driver in our decision to pursue registration in head and neck cancer has a first global registration pathway for NBTXR3.

隨著我們在 2022 年加快全球註冊研究的步伐，我們也即將完成研究 102。提醒一下，研究 102 是一項針對類似頭頸癌人群的劑量遞增和擴展研究，該研究繼續顯示出有希望的活性和是我們決定在頭頸癌中進行註冊的一個驅動因素，它擁有第一個 NBTXR3 全球註冊途徑。

Early in the year '23, we completed enrollment in Study 102 expansion phase. And you will recall, in February 2022, we reported an interim update with an ongoing median overall survival of 17.9 months in all treated population and 23 months in the evaluable patient population. We are planning to present top-line safety and efficacy data from the full study population in the second half of 2023 and plan to submit this data for presentation at a medical meeting.

23 年初，我們完成了 Study 102 擴展階段的註冊。你會記得，在 2022 年 2 月，我們報告了一項中期更新，所有治療人群的持續中位總生存期為 17.9 個月，可評估患者人群為 23 個月。我們計劃在 2023 年下半年展示來自全部研究人群的頂級安全性和有效性數據，併計劃提交這些數據以在醫學會議上展示。

We're also planning additional post-hoc analyses in 2023 that we believe will add to our understanding of the activity of NBTXR3 in head and neck cancer and further inform our assumption in the NANORAY-312. We believe the continued improvement in survival benefit already demonstrated in Study 102 reinforces the probability of success for Study 312 and suggests the anticipated delta between treatment and control arm may be larger than initially anticipated.

我們還計劃在 2023 年進行額外的事後分析，我們相信這將增加我們對 NBTXR3 在頭頸癌中的活性的理解，並進一步為我們在 NANORAY-312 中的假設提供信息。我們認為，已經在研究 102 中證明的生存獲益的持續改善增強了研究 312 成功的可能性，並表明治療組和對照組之間的預期增量可能比最初預期的要大。

If the final analysis remain in line with previously reported outcome, we believe this could potentially shorten the predicted overall time to expect data in the NANORAY-312. With this potential robustness in data, coupled with our operational efficiency, we expect, as planned, the interim efficacy and safety analysis for our pivotal NANORAY-312 trial after 67% of planned event in the second half of 2024. The futility analysis more heavily impacted by the first few months in study launch will be conducted following 25% of planned event, which is anticipated now to be in the first half of 2024.

如果最終分析與先前報告的結果保持一致，我們認為這可能會縮短 NANORAY-312 中獲得數據的預計總時間。憑藉這種潛在的數據穩健性，再加上我們的運營效率，我們預計在 2024 年下半年完成 67% 的計劃事件後，我們的關鍵 NANORAY-312 試驗將按計劃進行中期療效和安全性分析。無效性分析更為重要受前幾個月影響的研究啟動將在計劃事件的 25% 之後進行，現在預計將在 2024 年上半年進行。

Another treatment approach we are actively pursuing is using radiotherapy-activated NBTXR3 to initially prime the immune system followed by anti-PD-1 therapy. This combination has potential to be a game changer for cancer immunotherapy and is supported by encouraging data from Study 1100 or Phase 1 dose escalation and expansion trial in patients with advanced cancer.

我們正在積極尋求的另一種治療方法是使用放射療法激活的 NBTXR3 來初步啟動免疫系統，然後進行抗 PD-1 療法。這種組合有可能成為癌症免疫療法的遊戲規則改變者，並得到來自研究 1100 或晚期癌症患者的 1 期劑量遞增和擴展試驗的令人鼓舞的數據的支持。

In 2022, we completed a dose escalation phase of this study, establishing a recommended Phase 2 dose and open enrollment in the expansion phase. As a result of progressing this program, we had the opportunity to present an update at the SITC Conference in 2022, demonstrating durable response, including eight patients with over six months of disease control and five patients assailing disease control over than 12 months.

2022 年，我們完成了這項研究的劑量遞增階段，建立了推薦的 2 期劑量並在擴展階段開放註冊。由於推進了該計劃，我們有機會在 2022 年的 SITC 會議上展示了最新情況，展示了持久的反應，其中包括 8 名疾病控制超過 6 個月的患者和 5 名疾病控制超過 12 個月的患者。

These results continue to demonstrate not only improved therapeutic response among PD-1 treatment naive patients, but showed meaningful response among patients we had previously seen their cancer progress despite PD-1 therapy. We look forward to providing future update from Study 1100 as we continue the expansion phase of the study in the coming year.

這些結果繼續證明，不僅 PD-1 治療初治患者的治療反應得到改善，而且我們之前看到儘管 PD-1 治療後癌症進展的患者也表現出有意義的反應。隨著我們在來年繼續擴大研究階段，我們期待提供 Study 1100 的未來更新。

The positive activities seen in Study 1100 has supported our plan for Phase 3 registrational program for patients with locally recurrent or recurrent or metastatic head and neck cancer that are resistant to PD-1 therapy. In the first half of 2022, we received preliminary feedback from the FDA, suggesting a single randomized controlled trial that include a pre-specified comparative analysis of the overall response rate may support accelerated approval, pending confirmation of clinical benefit based on overall survival results of the same trial. Initially, we planned to submit a protocol to the FDA on a potential registrational pathway for NBTXR3 immunotherapy approach in the first quarter of 2023.

在研究 1100 中看到的積極活動支持了我們針對 PD-1 治療耐藥的局部復發或複發或轉移性頭頸癌患者的第 3 期註冊計劃計劃。在 2022 年上半年，我們收到了 FDA 的初步反饋，建議一項包括預先指定的總體反應率比較分析的單一隨機對照試驗可能支持加速批准，等待根據總體生存結果確認臨床益處同樣的審判。最初，我們計劃在 2023 年第一季度向 FDA 提交一份關於 NBTXR3 免疫治療方法的潛在註冊途徑的協議。

However, given we have a new CMO joining in the third quarter, we plan to consult with the incoming CMO prior to continue discussion with FDA. This individual has extensive experience in immunotherapy drug development. And given the significance of the program, interest in optimizing enrollment efficiency, and ensuring we are building a fundamental protocol supportive of regulatory reporting requirements and commercialization in a competitive landscape, we have decided for first review the current data and future program with our new CMO.

然而，鑑於我們在第三季度有一位新的 CMO 加入，我們計劃在繼續與 FDA 討論之前諮詢即將上任的 CMO。此人在免疫治療藥物開發方面擁有豐富的經驗。鑑於該計劃的重要性、對優化註冊效率的興趣以及確保我們在競爭環境中建立支持監管報告要求和商業化的基本協議，我們決定首先與我們的新 CMO 一起審查當前數據和未來計劃.

Based on this, we expect to provide an update for our NBTXR3 immunotherapy approach in the third quarter of 2023. Further, expansion opportunities for NBTXR3 are actively being explored as part of the ongoing collaboration with the University of Texas MD Anderson Cancer Center. Of note, we have determined the recommended Phase 2 dose for NBTXR3 in pancreatic ductal adenocarcinoma, and the principal investigator shared positive preliminary qualitative efficacy data in the fourth quarter of 2022.

基於此，我們預計將在 2023 年第三季度更新我們的 NBTXR3 免疫治療方法。此外，作為與德克薩斯大學 MD 安德森癌症中心正在進行的合作的一部分，正在積極探索 NBTXR3 的擴展機會。值得注意的是，我們已經確定了 NBTXR3 在胰腺導管腺癌中的推薦 2 期劑量，首席研究員在 2022 年第四季度分享了積極的初步定性療效數據。

MD Anderson expects to present preliminary Phase 1b dose escalation safety in pancreatic cancer in the second half of 2023. We look forward to the continued progress in this study, and as a dose expansion phase gets underway, a borderline respectable patient become eligible for enrollment alongside locally advanced patient evaluated in the dose escalation phase.

MD Anderson 預計將在 2023 年下半年展示胰腺癌的初步 1b 期劑量遞增安全性。我們期待這項研究的持續進展，並且隨著劑量擴展階段的進行，一名邊緣受人尊敬的患者將有資格入組在劑量遞增階段評估的局部晚期患者。

In addition to the upcoming data expected from pancreatic trial, MD Anderson has made significant progress in its Phase 1 trial of NBTXR3 in non-small cell lung cancer and expect to determine a recommended Phase 2 dose in this study in the second half of this year. As you recall, they are also leading a Phase 1 trial of NBTXR3, in combination with chemotherapy, for patients with esophageal cancer and are progressing toward an anticipated recommended Phase 2 dose in 2024.

除了即將公佈的胰腺試驗數據外，MD Anderson 在非小細胞肺癌 NBTXR3 的 1 期試驗中取得了重大進展，預計將在今年下半年確定該研究的推薦 2 期劑量.您還記得，他們還領導了 NBTXR3 聯合化療治療食管癌患者的 1 期試驗，並正在朝著 2024 年預期推薦的 2 期劑量推進。

Given the shift to our proton therapy in treating these patients, the study presents an interesting opportunity to validate prior preclinical data, suggesting the safety and potential benefit of combining NBTXR3 with proton therapy, which theoretically offers a reduction in the radiation exposure to LC-neighboring tissue whilst improvement of the therapeutic ratio. MD Anderson is in the process to modify the existing protocol to allow for introduction of proton therapy for court of patients in this study.

鑑於我們在治療這些患者時轉向質子治療，該研究提供了一個有趣的機會來驗證之前的臨床前數據，表明將 NBTXR3 與質子治療相結合的安全性和潛在益處，理論上可以減少 LC 鄰近細胞的輻射暴露組織，同時提高治療率。 MD 安德森正在修改現有協議，以允許在本研究中為法院患者引入質子治療。

At this juncture, we anticipate the study team reaching a recommended Phase 2 dose under the existing intensity-modulated radiation therapy protocol before introducing a second radiation therapy treatment modality sometime in 2024. And finally, I would like to note that MDA is working on additional clinical study in different patient population that we have not disclosed before, and we'll have more to say about this development in the future.

在此關頭，我們預計研究團隊將在 2024 年的某個時候引入第二種放射治療模式之前，根據現有調強放射治療方案達到推薦的 2 期劑量。最後，我想指出，MDA 正在研究額外的我們之前沒有披露過針對不同患者人群的臨床研究，未來我們將有更多關於這一進展的內容。

Finally, I would like to highlight that we have many value inflection points, see here in the coming 12, 24 months across all of our programs. We believe that NBTXR3 has the potential to enhance the utility of radiation therapy in many tumors, and we are moving on many fronts to make this vision a reality.

最後，我想強調的是，我們在未來 12、24 個月的所有計劃中都有許多價值拐點，請參見此處。我們相信 NBTXR3 有潛力提高放療在許多腫瘤中的效用，我們正在許多方面努力使這一願景成為現實。

I would like now to turn the call to Bart to briefly discuss our financial results for the period. Bart?

我現在想把電話轉給巴特，簡要討論一下我們這一時期的財務業績。巴特？

Thank you, Laurent. As Laurent mentioned, the enrollment of our first patient in in NANORAY-312 provides an exciting start to 2022, and our commitment to advancing this study remains our priority, defining how we navigated the remainder of the year.

謝謝你，洛朗。正如 Laurent 所提到的，我們的第一位患者加入 NANORAY-312 為 2022 年提供了一個令人興奮的開端，我們對推進這項研究的承諾仍然是我們的首要任務，這決定了我們如何度過今年餘下的時間。

As the broader economic pressure and market volatility persisted, we took quick action early in the second quarter to significantly expand our cost control efforts initiated in 2021 by prioritizing investments in NANORAY-312 and Study 1100, scaling back preclinical programs and optimizing manufacturing and infrastructure expense to ensure we are well positioned to execute our core programs. The results of these efforts to enhance operational efficiencies and improve our cost bases across all our programs are evident in the financial results we reported yesterday, where we see only the most increase in R&D expense of approximately EUR2 million compared to 2021, despite the initiation of our pivotal Phase 3 registration study, the continuation of Study 102, and our ongoing immunotherapy in combination Study 1100.

由於更廣泛的經濟壓力和市場波動持續存在，我們在第二季度初迅速採取行動，通過優先投資 NANORAY-312 和 Study 1100、縮減臨床前項目並優化製造和基礎設施費用，顯著擴大我們在 2021 年啟動的成本控制工作以確保我們有能力執行我們的核心計劃。這些旨在提高運營效率和改善我們所有計劃的成本基礎的努力的結果在我們昨天報告的財務結果中顯而易見，與 2021 年相比，我們看到研發費用僅增加了約 200 萬歐元，儘管啟動了我們關鍵的 3 期註冊研究、研究 102 的延續以及我們正在進行的聯合免疫療法研究 1100。

Likewise, you will note SG&A expenses decreased by EUR1.6 million, or 8.1%, from EUR19.4 million for the year ended December 31, 2021 to EUR17.9 million for the year ended December 31, 2022, reflecting our efforts to rationalize SG&A expenses and internalize key functions. While the company did not generate revenue in 2022, we successfully expanded eligible expenses and increased our overall research tax credits, as a result, by more than 60% year over year, and a portion of this gain represents a recurring increase to this credit.

同樣，您會注意到 SG&A 費用從截至 2021 年 12 月 31 日止年度的 1,940 萬歐元減少 160 萬歐元或 8.1% 至截至 2022 年 12 月 31 日止年度的 1,790 萬歐元，反映了我們為合理化工作所做的努力SG&A 費用並將關鍵職能內部化。雖然公司在 2022 年沒有產生收入，但我們成功地擴大了符合條件的支出並增加了我們的整體研究稅收抵免，因此，同比增長超過 60%，其中一部分收益代表了該抵免的經常性增加。

As a result, our total income increased significantly to EUR4.8 million for the year ended December 31, 2022, compared to EUR2.6 million for the year ended December 31, 2021. To further improve our financial flexibility and extend our operating runway, we've successfully restructured EUR30.7 million in outstanding debt with the European Investment Bank to significantly reduce near-term expense and better align our debt obligations with our anticipated development timelines. While the impact on our cash runway is clearly favorable, the restructuring resulted in a negative one-off valuation impact of EUR6.9 million.

因此，截至 2022 年 12 月 31 日止年度，我們的總收入大幅增加至 480 萬歐元，而截至 2021 年 12 月 31 日止年度為 260 萬歐元。為進一步提高我們的財務靈活性並擴展我們的經營範圍，我們與歐洲投資銀行成功重組了 3070 萬歐元的未償債務，以顯著減少近期支出，並更好地使我們的債務義務與我們預期的開發時間表保持一致。雖然對我們的現金跑道的影響顯然是有利的，但重組導致了 690 萬歐元的一次性估值負面影響。

Combined with higher interest costs on the loan and lower foreign exchange gains, our net loss for 2022 was EUR57 million or EUR1.64 per share for the 12-month period ended December 31, 2022. This compares to a net loss of EUR47 million or EUR1.35 per share for the year ended December 31, 2021.

加上較高的貸款利息成本和較低的外匯收益，截至 2022 年 12 月 31 日止的 12 個月期間，我們 2022 年的淨虧損為 5700 萬歐元或每股 1.64 歐元。相比之下，淨虧損為 4700 萬歐元或截至 2021 年 12 月 31 日止年度每股 1.35 歐元。

You will also recall that we took steps to ensure future access to capital, unsecured and equity financing loan, through Kepler Cheuvreux in the second quarter of 2022. While we have not yet tapped this equity line, we have the full authority to exercise or suspend access to capital through this facility at any time at our sole discretion.

您還會記得，我們已採取措施確保未來在 2022 年第二季度通過 Kepler Cheuvreux 獲得資本、無擔保和股權融資貸款。雖然我們尚未動用這條股權線，但我們有充分的權力行使或暫停我們可以自行決定隨時通過該設施獲得資金。

As of December 31, 2022, Nanobiotix had EUR41.4 million in cash and cash equivalents, compared to EUR83.9 million as of December 31, 2021. Our press release that we released last night noted our cash, combined with our equity line financing, will fund operations into the third quarter of this year, which is a shorter runway than our previous guidance into first quarter of 2024.

截至 2022 年 12 月 31 日，Nanobiotix 擁有 4140 萬歐元的現金和現金等價物，而截至 2021 年 12 月 31 日為 8390 萬歐元。我們昨晚發布的新聞稿提到了我們的現金，加上我們的股權融資，將為今年第三季度的運營提供資金，這比我們之前對 2024 年第一季度的指導要短。

Our loan with the EIB carries a covenant requirement cash balance of EUR25.3 million, which is equivalent to the outstanding principal we are now getting [currently]. The EIB has granted a temporary waiver of this requirement of EUR15 million until December 31. The temporary waiver will be automatically extended until January 31, 2024 before signing of a business development partnership, collaborative or strategic alliance.

我們在 EIB 的貸款有 2530 萬歐元的契約要求現金餘額，這相當於我們現在 [current] 獲得的未償還本金。 EIB 已批准在 12 月 31 日之前臨時豁免此 1500 萬歐元的要求。在簽署業務發展夥伴關係、合作或戰略聯盟之前，臨時豁免將自動延長至 2024 年 1 月 31 日。

Because the company is not reporting such an event at this time, the waiver is assumed by us and our auditors to be expiring on July 31. And because our projected cash and cash equivalents balances are expected to decline below the EUR25.3 million level in Q3, we are reporting a cash runway that extends only to the time based on the conservative series of assumptions that include no business development deals, no new financing, and the assumption the EIB will exercise the covenants and seek repayment of the loan in full.

由於公司此時未報告此類事件，我們和我們的審計師假設豁免將於 7 月 31 日到期。並且由於我們預計現金和現金等價物餘額預計將下降至 2530 萬歐元以下第三季度，我們報告的現金跑道僅延伸到基於保守系列假設的時間，這些假設包括沒有業務發展交易、沒有新融資，以及 EIB 將履行契約並尋求全額償還貸款的假設。

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

現在，我會將電話轉回給 Laurent。洛朗？

Thank you, Bart. In 2022, we continued our prioritized focus on further advancing NBTXR3 treatment of head and neck cancer. To date, the totality of clinical data continues to support the potential of our product to offer a meaningful therapeutic benefit to a large number of patients in oncology.

謝謝你，巴特。 2022 年，我們繼續優先關注進一步推進 NBTXR3 對頭頸癌的治療。迄今為止，全部臨床數據繼續支持我們的產品為大量腫瘤患者提供有意義的治療益處的潛力。

Our initial focus in head and neck cancer is establishing a framework that can be expanded and replicated across other solid tumors and, as a reminder, we know that around 60% of all cancer patients who receive radiation therapy. With the recent strengthening of operation and executive leadership, we believe we are well positioned to execute across our near-term catalysts through the year.

我們最初對頭頸癌的關注是建立一個可以擴展和復製到其他實體瘤的框架，提醒一下，我們知道大約 60% 的癌症患者接受了放射治療。隨著近期運營和行政領導的加強，我們相信我們有能力在全年執行我們的近期催化劑。

Looking ahead, '23 will be a foundational year for several reasons, and including different milestones and clinical data that we should expect. On our primary focus, head and neck cancer, we will have the final data coming from the Phase 1/2 Study 102, also an update on the 1100, and we continue and we will continue to progress in the pivotal trial NANORAY-312 to prepare, as planned, the interim readout for H2 '24.

展望未來，出於多種原因，23 年將是基礎年，包括我們應該期待的不同里程碑和臨床數據。關於我們的主要關注點，頭頸癌，我們將獲得來自 1/2 期研究 102 的最終數據，也是 1100 的更新，我們將繼續並將繼續推進關鍵試驗 NANORAY-312 以按計劃準備 H2 '24 的臨時讀數。

In addition to our priority focus, head and neck, we will get the first data coming from our last collaboration with MD Anderson, including pancreatic cancer and lung cancer trial results.

除了我們優先關注的頭部和頸部，我們還將獲得我們與 MD Anderson 上次合作的第一批數據，包括胰腺癌和肺癌試驗結果。

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

有了這個，我現在將讓接線員開始我們的問答環節。操作員？

(Operator Instructions) Jonathan Miller, Evercore ISI.

（操作員說明）Jonathan Miller，Evercore ISI。

Hey, guys. Thanks for taking my question. Let's start with the head and neck studies. I'd love if you could give us some more color on the protocol amendment you're talking about for 312 that might increase enrollment rates.

大家好。感謝您提出我的問題。讓我們從頭部和頸部研究開始。如果你能給我們更多關於你正在談論的 312 協議修正案的顏色，我很樂意，這可能會提高入學率。

And relatedly, I noticed you're sticking to guidance for data in the second half of '24. You also alluded to the possibility that there's an acceleration possible there based on Study 102 readout. Can you talk about the pushes and pulls there, and how much this could impact timeline to the 312 readout?

與此相關，我注意到你在 24 年下半年堅持數據指導。您還提到了根據 Study 102 讀數可能存在加速的可能性。你能談談那裡的推動和拉動嗎，這會對 312 讀數的時間線產生多大影響？

Thank you, Jonathan, for the question. So head and neck study pivotal trial, as you know, is a randomized Phase 3 study that is run globally, US, Asia, and Europe. And here, that's a 500-patient trial, randomized one to one, where early on, via our partner, will treat 100 patients out of the 500 total.

喬納森，謝謝你提出這個問題。因此，如您所知，頭頸研究關鍵試驗是一項在全球、美國、亞洲和歐洲開展的隨機 3 期研究。在這裡，這是一項 500 名患者的試驗，一對一隨機分配，早期通過我們的合作夥伴，將治療 500 名患者中的 100 名患者。

So to date, what we've been seeing is after a slow start of this trial, as expected in such a complex time with the war in Ukraine and the end of the COVID period, we're seeing a good ramping up of the patient recruitment right now and have been able, across the year, to get much more sites activated and also open new countries that were not initially planned in order to compensate the loss of Ukraine and Russia and also the slow start of the trial.

因此，到目前為止，我們所看到的是，在這個試驗開始緩慢之後，正如預期的那樣，在烏克蘭戰爭和 COVID 時期結束的如此復雜的時期，我們看到患者人數在增加現在就開始招募，並且已經能夠在一年中激活更多的網站，並且還開放了最初沒有計劃的新國家，以彌補烏克蘭和俄羅斯的損失以及試驗的緩慢啟動。

In addition to that, we looked at real world and discuss with our investigator in this trial to look at how can we ease the patient recruitment in this trial. So we've been doing some minor amendments in order to facilitate the number of patients that could have access to this trial. And that includes, but not limited to, some better or easier definition of what will be the eligibility to cisplatin in order to include more patients.

除此之外，我們著眼於現實世界，並與我們的研究人員在本試驗中進行討論，以了解我們如何才能簡化本試驗中的患者招募。因此，我們一直在進行一些小的修改，以增加可以參與該試驗的患者數量。這包括但不限於一些更好或更容易定義順鉑的資格以包括更多患者。

We also have included a bit more patients in term of T&M definition and had been the previous background and record data from the patient entering the trial. So all this, we think, will help to accelerate the recruitment rate. And just of note, to date, we have only a part of the final number of sites that we expect that are currently recruiting. There's two sites happening. So we expect two things that make us think that we'll have another inflection point in the recruitment rate is the increasing number of site recruiting, and this amendment of the protocol that will start being actually in site within the next two months. So that's for 312 itself.

在 T&M 定義方面，我們還包括了更多的患者，並且是之前進入試驗的患者的背景和記錄數據。因此，我們認為，所有這些都將有助於加快招聘速度。需要注意的是，到目前為止，我們只有我們預計目前正在招聘的網站最終數量的一部分。有兩個網站正在發生。因此，我們預計有兩件事會讓我們認為招聘率將出現另一個拐點，那就是網站招聘數量的增加，以及協議的修訂將在未來兩個月內開始實際出現在網站上。所以這是針對 312 本身的。

I think, looking now at the 102 trial, which was the first part of the development in head and neck cancer, so that's a Phase 1/2 that includes an escalation part and an expansion part, where we've been treating total of 72 patients in a similar population. We've seen already in the past that the overall survival of the evaluated population in this trial was around 23 months, and we expect to be able to report final data later this year that include all the patients with at least 12 months follow up that we expect to be quite similar to what we have seen so far.

我認為，現在看 102 試驗，這是頭頸癌發展的第一部分，所以這是一個 1/2 階段，包括升級部分和擴展部分，我們總共治療了 72 名患者相似人群中的患者。我們過去已經看到，該試驗中被評估人群的總生存期約為 23 個月，我們希望能夠在今年晚些時候報告最終數據，其中包括至少 12 個月隨訪的所有患者我們期望與我們目前看到的非常相似。

Now, what is interesting is that we continue to dig in the data we have generated in this trial, and we expect to report, on the top of what was planned as per protocol, some additional data that could help us to understand how this should play out in the 312 trial. In all regards, we think we are confident, given what we have seen so far, and increase our internal probability of success of the 312 based on what we have seen so far.

現在，有趣的是我們繼續挖掘我們在這個試驗中產生的數據，我們希望在按照協議計劃的基礎上報告一些額外的數據，這些數據可以幫助我們理解這應該如何在 312 審判中發揮作用。在所有方面，鑑於我們目前所見，我們認為我們有信心，並根據我們目前所見提高 312 的內部成功概率。

Okay. Makes sense. One more for me. I would love to hear more about your runway assumptions. I understand the updated runway doesn't include the equity line or other sources of capital and is making conservative assumptions about these debt covenants. What would the runway be if you did include all of your anticipated, not additional BD, but already negotiated equity lines, full access to the debt, and no covenants? What would the less conservative runway look like?

好的。說得通。給我一個。我很想听聽更多關於你的跑道假設。我知道更新後的跑道不包括股權線或其他資本來源，並且正在對這些債務契約做出保守假設。如果您確實包括所有預期的而不是額外的 BD，但已經談判的股權額度、完全獲得債務且沒有契約，跑道會是什麼？不那麼保守的跑道會是什麼樣子？

Thank you, Jon, for the question. This is Bart on the line. That would not have changed in what we have guided to previously, which would be Q1 of '24.

喬恩，謝謝你提出這個問題。我是巴特。這不會改變我們之前指導的內容，即 24 年第一季度。

Okay. Thank you very much.

好的。非常感謝。

Elliott Bosco, UBS.

埃利奧特博斯科，瑞銀。

Hi, everyone. Elliott Bosco on for Colin Bristow from UBS. Another one on NANORAY-312 recruitment, could you elaborate a little bit more on some of the regulatory challenges you're facing? And additionally, could you speak to the amount of sites that needed to be replaced or incrementally added through some of the challenges.

大家好。 Elliott Bosco 從 UBS 換下 Colin Bristow。另一個關於 NANORAY-312 招募的問題，您能否詳細說明您面臨的一些監管挑戰？此外，您能否談談需要通過一些挑戰替換或增量添加的網站數量。

And then last question, could you provide additional commentary on your strategy for potential collaborations or partnerships? Thank you.

最後一個問題，您能否就您的潛在合作或夥伴關係戰略提供更多評論？謝謝。

Thank you. So in terms of the regulatory challenge, I think, in Europe, as we know, our product has a medical device status. And for most of the rest of the world, it is a drug. And as there is a fundamental reshaping in the medical device status in Europe and regulation around that, we went through some hurdle in order to connect our old regulatory system versus new regulatory system in Europe.

謝謝。因此，就監管挑戰而言，我認為在歐洲，正如我們所知，我們的產品具有醫療器械地位。對於世界其他大部分地區來說，它是一種藥物。由於歐洲的醫療器械地位和相關監管發生了根本性的重塑，我們經歷了一些障礙，以便將我們的舊監管系統與歐洲的新監管系統聯繫起來。

So we went through a number of interaction with agencies in order to connect the dots and to be able to start the trial. So this has been causing some delays, which did not happen in other countries. In Asia, we've seen some lockdowns due to the COVID no later than end of last year, and beginning of this year was still the case that now it's real. And for US, that meant other was about the COVID tail, where it has slowed down most of the activities in hospitals. We think, now, everything is back to normal, and we're progressing well on every front.

因此，我們與機構進行了多次互動，以便將各個點聯繫起來並能夠開始試驗。因此，這造成了一些延誤，這在其他國家/地區沒有發生。在亞洲，我們看到不遲於去年底由於 COVID 導致的一些封鎖，而今年年初仍然如此，現在它已經成為現實。對於美國來說，這意味著其他是關於 COVID 的尾巴，它減緩了醫院的大部分活動。我們認為，現在一切都恢復正常了，我們在各個方面都取得了良好的進展。

Now, in terms of replacing the sites that have been closed in Ukraine and Russia beginning of last year, we've been opening more sites in other countries that were already opened, like France and Spain and others, but also have added two or three other countries in order to compensate that. So the idea here was to make sure that by adding those sites in existing or new countries will recompensate the exclusion of Russia and Ukraine at the beginning and the little start that's a little slow versus what's expected.

現在，就替換去年初在烏克蘭和俄羅斯關閉的網站而言，我們已經在其他國家開放了更多已經開放的網站，例如法國和西班牙等，但也增加了兩三個其他國家以彌補這一點。因此，這裡的想法是確保通過在現有或新國家/地區添加這些站點來補償開始時將俄羅斯和烏克蘭排除在外以及與預期相比有點慢的小開始。

But the good thing is now, we see a very good ramp up in terms of recruitment and all base statistician. With the real-word life recruitment rate that we see today and the ramp up we see inside exploration, we maintain our guidance to get the interim readout second half of '24.

但好在現在，我們在招聘和所有基礎統計人員方面看到了非常好的增長。憑藉我們今天看到的真實生活招聘率和我們在內部探索中看到的增長，我們維持我們的指導以獲得 24 年下半年的中期讀數。

And sorry, what was the last part of the question? Yes, partnership, right?

抱歉，問題的最後一部分是什麼？是的，夥伴關係，對吧？

Yeah, your strategy to partnerships, collaborations. Thank you.

是的，你的伙伴關係、合作戰略。謝謝。

Okay. So just maybe a piece of context. I think we all see how the market is for the past 18 months, two years, and even a bit more. So in an efficient market, it will make sense and would that make sense to raise more money in order to pass the interim readout in order to create more value. And after that step, maybe establishing some partnership and collaboration with industry.

好的。所以也許只是一段背景。我想我們都看到了過去 18 個月、兩年甚至更長時間的市場情況。因此，在一個有效的市場中，籌集更多資金以通過臨時讀數以創造更多價值是有意義的，也是有意義的。在那一步之後，也許會與行業建立一些夥伴關係和協作。

Now, as we all see the market is not what we would hold high as expected to be, so we changed our strategy in the recent past. And we see like collaboration or industrial partnership as a key option for Nano in order to move forward and guarantee that we can reach a lot of patients and also guaranteeing the value for shareholders.

現在，正如我們所看到的那樣，市場並不像我們預期的那樣高漲，所以我們在最近改變了我們的策略。我們將類似的合作或工業夥伴關係視為 Nano 的一個關鍵選擇，以便向前發展並保證我們能夠接觸到很多患者，同時也保證股東的價值。

Thank you. That's all for me.

謝謝。這就是我的全部。

RK, H.C. Wainwright.

RK, H.C.溫賴特。

Thank you. Good morning, Laurent and Bart. Just a couple of quick questions. Just trying to find out if there's going to be any clinical data presentations at ASCO coming up. And also, when MD Anderson releases data on pancreatic cancer later this year, how are you thinking about taking this indication forward, expecting this data to be positive from here?

謝謝。早上好，洛朗和巴特。只是幾個簡單的問題。只是想知道在 ASCO 上是否會有任何臨床數據展示。而且，當 MD Anderson 在今年晚些時候發布胰腺癌數據時，您如何考慮推進這一適應症，並期望從這裡獲得的數據是積極的？

Thank you for the question. So yes, we expect at ASCO and other conferences for the second part of the year to present new data with our program. We will disclose in due time at which conference obviously we will present different data we have. But as you mentioned briefly, we expect to present the final data of the 102 study and also some other data coming from this study and update on the 1100 and the trial coming from MD Anderson.

感謝你的提問。所以，是的，我們希望在今年下半年的 ASCO 和其他會議上通過我們的計劃展示新數據。我們將在適當的時候披露在哪個會議上，顯然我們將展示我們擁有的不同數據。但正如您簡要提到的那樣，我們希望展示 102 研究的最終數據以及來自該研究的一些其他數據，以及來自 MD Anderson 的 1100 和試驗的更新。

And as far as MD Anderson is concerned, we wait to get the lung cancer trial first results, but also pancreatic cancer trial data. I think that, as we mentioned, a very interesting trial because we think here, we could have a big impact for the patient. And what we should look at when the data coming out is the population we are treating here. We're talking about locally advanced pancreatic cancer patients that are fully [inoperable].

就 MD Anderson 而言，我們等待獲得肺癌試驗的第一個結果，還有胰腺癌試驗數據。我認為，正如我們提到的，這是一項非常有趣的試驗，因為我們認為，我們可以對患者產生重大影響。當數據出來時，我們應該看的是我們在這裡治療的人群。我們談論的是完全[無法手術]的局部晚期胰腺癌患者。

And for those patients, usually there is not much of a therapeutic option. What we have been doing after this patient getting a round of chemo as the standard of care is what is proposed. We have been injecting NANORAY and then activate it by radiation and look at the outcome for the patient. So what will be important here is to see how much of this patient we can stabilize, how much potentially we could have response, which is rare in this population, even more rare is how many of these patients could get surgery coming from inoperable to operable.

對於這些患者，通常沒有太多的治療選擇。在這名患者接受一輪化療作為標準治療後，我們一直在做的就是所提議的。我們一直在註射 NANORAY，然後通過輻射激活它，並查看患者的結果。因此，這裡重要的是看看我們可以穩定多少患者，我們可能有多少反應，這在這個人群中很少見，更罕見的是這些患者中有多少可以從無法手術變為可手術.

And so all those data will be presented. And then, for you to know, we also have started the expansion part of this trial that we expect to conclude before the end of the year. And based on all these data, we think we should be able to propose a next step for pancreatic cancer patients. Now, what's not yet decided is the format of this next step for the pivotal trial. Will it be something else? So that will be discussed a bit further, and I think we'll give an update on that when we present the data of this trial.

因此，所有這些數據都將被呈現。然後，如您所知，我們還開始了該試驗的擴展部分，我們預計將在今年年底前完成。基於所有這些數據，我們認為我們應該能夠為胰腺癌患者提出下一步治療方案。現在，尚未決定的是關鍵試驗下一步的形式。會是別的東西嗎？因此，我們將進一步討論這一點，我想我們會在展示該試驗的數據時對此進行更新。

Thank you, Laurent. Thanks for taking my question.

謝謝你，洛朗。感謝您提出我的問題。

Thank you, RK.

謝謝你，RK。

Clément Bassat, BNP Paribas.

Clément Bassat，法國巴黎銀行。

Hello. Thank you for taking my question. Just one about your relationship with the EIB. You advised that the EIB is willing to extend for six months their requirement of EUR15 million in a grant instead of EUR25 million, but the condition is to find a partner. And I have in mind your CE mark in the STS program, and did they request or strongly suggest you to start the commercial phase on this program in Europe? And finally, are you in touch with the potential partners to do that? Thank you.

你好。謝謝你提出我的問題。只是關於您與 EIB 的關係。您告知 EIB 願意將其 1500 萬歐元的贈款要求延長六個月，而不是 2500 萬歐元，但條件是找到合作夥伴。我還記得你們在 STS 計劃中的 CE 標誌，他們是否要求或強烈建議你們在歐洲開始該計劃的商業階段？最後，您是否與潛在的合作夥伴保持聯繫？謝謝。

Thanks for the question. I think the STS is an interesting and important question. As you know, we've been successful in running a Phase 3 randomized trial, proving the superiority of NBTXR3 over the standard of care in a very hard to treat patient population, which is locally advanced soft-tissue sarcoma patients.

謝謝你的問題。我認為 STS 是一個有趣且重要的問題。如您所知，我們已經成功地進行了一項 3 期隨機試驗，證明了 NBTXR3 在非常難以治療的患者群體（即局部晚期軟組織肉瘤患者）中優於護理標準。

Now, we also obtained the CE mark for that a few or two years ago. And the idea here is to capitalize on the existing CE mark, so when we get the head and neck data and hopefully positive interim readout that we could submit an extension use of the NBTXR3 to go from STS to head and neck cancer patients.

現在，我們也在幾兩年前獲得了 CE 標誌。這裡的想法是利用現有的 CE 標誌，所以當我們獲得頭頸數據並希望獲得積極的中期讀數時，我們可以提交 NBTXR3 的擴展使用，從 STS 到頭頸癌患者。

We will not start commercializing with soft-tissue sarcoma because that will be globally detrimental to the whole franchise of NBTXR3. And also, the effort we have to deploy to make this product commercially available across Europe will not be interesting versus starting first with head and neck and obtaining a potential good price, a fair price, for the product and then extend it to the soft-tissue sarcoma and then start selling both in head and neck and STS.

我們不會開始將軟組織肉瘤商業化，因為這將在全球範圍內損害 NBTXR3 的整個特許經營權。而且，與首先從頭部和頸部開始並為產品獲得潛在的好價格、公平的價格，然後將其擴展到軟-組織肉瘤，然後開始在頭頸部和 STS 中銷售。

Now, as far as EIB's concerned on this topic, their fully backed strategy on this has potential ongoing discussion we have, talking about STS and the strategy to start with head and neck. It's seen by all our potential and existing collaborators as the right time to move forward.

現在，就 EIB 對這個話題的關注而言，他們在這方面得到充分支持的戰略有可能與我們進行持續討論，討論 STS 和從頭頸開始的戰略。我們所有潛在和現有的合作者都認為這是向前邁進的正確時機。

All right. Thank you.

好的。謝謝。

Thank you.

謝謝。

Thank you. There are no further questions at this time. I would now like to hand the call back over to management for any closing comments.

謝謝。目前沒有其他問題。我現在想將電話轉回給管理層，徵求任何結束意見。

Thank you. So I will just would like to thank you all for participating to this call, and we look forward to further executing across our upcoming milestones. And we'll continue, of course, to keep you updated on our progress and our fully and obviously much more clinical data that will come this year.

謝謝。因此，我只想感謝大家參加這次電話會議，我們期待著進一步執行我們即將到來的里程碑。當然，我們將繼續讓您了解我們的進展以及我們今年將提供的全面而明顯的更多臨床數據。

Thank you very much, and I wish you all a very good day.

非常感謝，祝大家度過愉快的一天。

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

謝謝。今天的電話會議到此結束。感謝您的參與。此時您可以斷開線路。享受你剩下的一天。