Nanobiotix S.A.

Good day and welcome to the Nanobiotics Business Update and Full Year 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. At this point, I will now turn the call over to Craig West, Senior Vice President of Investor Relations of Nanobiotics. Please go ahead.

Thank you. Good afternoon, good morning, and welcome to the Nanobiotics 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 Ryn, chief financial officer. 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. 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. 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. 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, InnoBiotics undertakes no obligation to update them to reflect subsequent events or future circumstances. With that, I'd like to turn the call over to Laurent. Please go ahead.

Thank you, Craig. And thank you, everyone, for joining us today. As Craig mentioned, we issued a press release yesterday highlighting the company's four years of working activity and financial results for 2023. For today's call, I would like to begin with an overview of our accomplishments and upcoming milestones before turning the call over to Bart to address the financial results. Then I will provide closing remarks before opening up the call for questions. 2023 was an incredible year of progress for nanodiatics and our program on MBTXR3. Last summer, we entered into a $2.5 billion license agreement with Johnson Pharmaceuticals, a Johnson & Johnson company, to expand the worldwide potential of MBTXR3, a potential first-in-class regulatory answer with universal application across political norms. led in 2023, our partner, LiangBio, assigned its right to NVTXR3 in China and other Asian markets to Jensen, thus consolidating global development and commercialization rights with Jensen, which is now responsible for the $205 million in milestones potentially available to us with this partnership. We also reported positive data from two key programs, including final and exploratory data from Study 102. our Phase I trial in head and neck cancer, as well as initial data from our Phase I-B 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. First, let's start with our Global Licensing for Development and Commercialization Agreement with Janssen for MDT-XR3. This partnership is designed to leverage the complementary strength of both companies, accelerating and broadening the treatment potential of MDT-XR3. 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 MDT-XR3, and importantly, further validate our platform and scientific approach. We believe that this collaboration with our partner at the International Oncology Group at J&J has the potential to impact the lives of many patients. We believe this because MBTXR3 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. As a reminder, For those new to the story, MBTXR3 is a biologically inert electron-dense nanoparticle. It is a one-time treatment that is designed to be injected directly into a solid tumor prior to a course of radiation to amplify the anti-tumor activity of radiotherapy. MBTXR3 is made up of asinine 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. This universal mode of action of NBT-XR3 as a radioenhancer offers broad application potential across 60% of patients with solid tumor that receive radiation during the course of their treatment. This potential of NVT-XR3 is something that we have been actively evaluating in hundreds of patients across eight tumor types treated to date. We continue to see strong proof-of-concept data that supports a well-tolerated safety profile and robust antitumor activity with radiotherapy-activated NVT-XR3 treatment. Our prioritized focus has been the late-stage development of NVT-XR3 in head and neck cancer which include an ongoing global registrational trial, the NAMORED 312 study, in elderly patients with locally advanced head and neck cancer, as well as treatment approach using radiative therapy-acidated MBTI-PAR3 to help with local control of the injected tumor, as well as initially prime the immune system, followed by anti-PD-1 therapies. We believe this combination has the potential to be a game-changer for cancer immunotherapy. and is supported by encouraging data from study 1100 of phase one trials in patients with advanced cancer, including those that are anti-PD-1 naive as well as those whom anti-PD-1 therapy has failed. We also continue to generate additional early stage data to support the clinical potential of MDT-XR3 across different solid tumor indications as part of our collaboration with MD Anderson. This effort includes five ongoing clinical trials in advent solitumol with lung or liver metastasis, recurrent or metastatic head and neck cancer, inoperable non-small cell lung cancer, esophageal cancer, and pancreatic cancer. 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 right in Asia, assigned by Liam Dyer to J&J. The deal values include advance and in-time support and a number of development and regulatory milestones for the first indication in head and neck cancer and lung cancer, along with sales milestones that together potentially total up to 1.8 billion. There are additional regulatory and development milestones for new indications that Janssen may develop over time of up to 650 million in aggregate. For any new indication that nanobiotics will develop and bring to market, there will be an additional $220 million per new indication. Of course, this deal also includes tiered royalties that go from low-yields to low-20s. In June, we have secured $114 million growth in funding, which includes several deals related to payment and equity rates. This equity deal was supported by a major shareholder and also provided GMJ the opportunity to become a nanobiotic shareholder. ADVANCE will review in more depth shortly we are pleased to have significantly strengthened our balance sheet, removed the PIB cash government, and expanded our cash flow rate into the third quarter of 2025. Looking ahead, we are strongly positioned to further advance and maximize the therapeutic potential of M-GTXR3 within the solid tumor treatment landscape. Turning to our clinical progress earlier this year, we reported positive final safety and efficacy data and the successful completion of study one or two. Our phase one dose escalation and expansion study in head and neck cancer at the annual AFCROM meeting. The robust anti-tumor efficacy and well-tolerated profile in a vulnerable elderly population with high comorbidity burden was encouraging. and included a 64 complete response rate and 82 overall response rate. We also saw a median progression for survival of 16.9 months and a median overall survival of 23.1 months, which is nearly the double survival reported in historical data. This data inform on next steps and support the hypothesis underlining design of our registrational nanowire 312 phase 3 study. Additional signs of efficacy in exploratory analyzes presented at the 23th ESMO Congress provided further confidence in our ongoing SENS-3 study, including a 42.8-month median overall survival observed in the 82% evaluable population who had a response in the NB-TXR3 injected lesion, compared to 18.1 months in the all-treated population. Importantly, a positive correlation associated with objective response PFS and OS extension was observed in the radiotherapy-activated MBTXR3-injected lesion. This high rate of response in over 80% of treated patients linked to the extended survival beyond 40 months is encouraging and supports the potential of MBTXR3 to change treatment paradigms in this patient population. Importantly, there are several key aspects of this Phase I data that give us confidence in the design and potential outcome of our registrational nanowire 312 study. The first is the extended survival observed in this elderly and highly comorbid population. We have also applied learning from our phase one study, which has the potential to optimize treatment outcome in the phase three trial. This includes injection both of the primary lesion and the possibility to inject lymph nodes in the phase three trial instead of just the primary lesion as was done in phase one study. Additionally, TREAT-well will enroll a broader population and will be stratified on comorbidities. Collectively, we believe this modification has potential for enhanced outcome over our phase one findings. But let's be clear, if we reach similar outcome as our phase one trial, then the TREAT-well should be able to be successful. We expect to report initial test-free interim efficacy and safety data after 67% of planned PFS add-ons in mid-25, which, if positive, could enable eligibility for accelerated approval had been discussed with the US FDA. 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 in DTXR3 after cytotoxic chemotherapy in patients with locally advanced pancreatic cancer at the ASCR Special Conference on Pancreatic Cancer and ESMO. 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 supports the feasibility and promising durable antitumor efficacy of radiotherapy-activated MBTX artery in temporary cancer. The ASMO data potentially helped 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 achieving patients who previously received a chemotherapy induction followed by radiation, plus a second course of chemotherapy. In other words, the same center-controlled patients received one additional course of chemotherapy versus the MDT-XR-treated patients. To put this into perspective, When we look at the comparative data that have been previously obtained by MD-Endoscan, we are seeing promising therapeutic potential versus this historical control. We plan to discuss this data with our partner MD-Endoscan and Johnson & Johnson to assess potential next steps for patients with pancreatic cancer. In our effort to further advance clinical development and commercialization of the MDT-XR3, we were pleased to welcome industry veteran, Dr. Rikai Tahir, to our executive leadership team as chief medical officer. Dr. Tahir brings an exceptional biopharmaceutical industry track record with proven success in development, registration, and commercialization of oncology therapeutics. Each season, innovative leadership has and will continue to be invaluable as we focus on maximizing the disruptive potential of our radionensers for millions of patients with cancer around the world. 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 P1 treatment naive and refractory patients. We also expect initial chemotherapy combination data in esophageal cancer from an Andy Anderson collaboration. With that, I would like now to turn the call over to Bart to briefly discuss the financial results for the period. Bart?