Nanobiotix S.A.

Good day, and thank you for standing by. Welcome to the Nanobiotics Business Update and Full Year 2022 Financial Results Conference Call. A slide presentation accompanying this call can be found at the investor section of the company's website at www.nanobiotics.com. 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 turn the call over to Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics.

Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations of Nanobiotics. Craig West, Senior Vice President of Investor Relations 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 CSCC in the United States, including the URD and 20F 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. 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, nanobiotics undertakes no obligation to update them to reflect subsequent events or future circumstances. With that said, I'd like to turn the call over to Laurent. Please go ahead.

Thank you, Craig. I would like to welcome everyone participating via conference call and webcast today. I would also like to welcome Greg to his first Nanobiotics 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 opportunities to do so soon. As Greg mentioned, we issued a press release yesterday highlighting the company's four years 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 programs before turning the call over to Bart to address financial results after we will open the call for your question. Each year since initiating development of our lead candidate NBT-XR3, we have seen evidence continue to mount suggesting NBT-XR3 has the potential to change the way solid tumors are treated and improve outcomes for patients. This past year, not only saw this trend continue, but also provided an opportunity to showcase the strength and agility of Nanobatic'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. 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 NANARATE 312, our global phase 3 trial in head and neck cancer in the U.S., 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 our debt obligation. As this achievement suggests, the capability and commitment of our team are as critical to our success as is the promise of NBT-XR3. It is further testament to both that during the challenges of 2022, we continue to attract new talent to join our mission to improve the lives of cancer patients through the development of NBT-XR3. This started early in the year when Strengthen, our executive leadership team, with the appointment of Dr. Leonard Farber, 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 a scientific advisory board comprised of leading global radiation, medical, and surgical oncologists involved in oncology treatment, decision-making, clinical trial investigation, and patient recruitment. 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 lead-stage development of our product, NBT-XR3. As you know, we started 2022 with the randomization of our first patient in NanoRed 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. Their diligence and execution, supported by our partner at Leon Bio, 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. 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 regionally lockdown that persisted intermittently through 2022. And finally, we had to replace the Ukrainian and Russian site that were originally selected. 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. 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 approvals complete or in the final stage, we can move quickly to onboard the remaining target site plan for Nanowrite 312. and are reassured by the uptick in the enrollment we are seeing following the addition of new sites and the implementation of our high-touch clinical operation engagement strategy. We expect continued progress in adding sites and seeing the recently added site initiate enrollment. Further, through the increasingly close partnership with investigators fostered by this effort, we identified a new factor that could facilitate patient enrollment, and as a result, are close to the finalization of a minor protocol amendment to clarify and ease the inclusion criteria and simplify patient identification, screening, and enrollment without changing the overall target patient population. 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 as the first global registration pathway for NBT-XR3. 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 available 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. We are also planning additional post-doc analysis in 2023 that we believe will add to our understanding of the activity of NBTX artery in head and neck cancer and further inform our assumption in the Nanorad 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. 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 non-array 312. With this potential robustness in data, coupled with operational efficiency, we expect, as planned, the interim efficacy and safety analysis for pivotal Nanowire 312 trial after 67% of planned event in the second half of 2024. The fertility 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. Another treatment approach. we are actively pursuing is using radiotherapy-activated NBT-XR3 to initially prime the immune system, followed by anti-PD-1 therapies. This combination has potential to be a game changer for cancer immunotherapy and is supported by encouraging data from study 1100 of phase one dose escalation and expansion trial in patients with advanced cancer. In 2022, we completed a dose escalation phase of this study, establishing a recommended phase two dose and open enrollment in the expansion phase. As a result of progress in this program, we had the opportunity to present an update at the CITC conference in 2022, demonstrating durable response, including eight patients with over six months of disease control and five patients receiving disease control over than 12 months. This results continued to demonstrate not only improved therapeutic response among PD-1 treatment-naive patients, but showed meaningful response among patients who had previously seen their cancer progress despite PD-1 therapy. We look forward to providing future updates from Study 1100 as we continue the expansion phase of the study in the coming year. The positive activity seen in study 11 and greater 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 plan to submit a protocol to the FDA on a potential registration or pathway for a BTXR3 immunotherapy approach in the first quarter of 2023. However, given we'll 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 requirements and commercialization in a competitive landscape, we have decided for first review the current data and future program with our new CMO. Based on this, we expect to provide an update for our NBT-XR3 immunotherapy approach in the third quarter of 2023. Further expansion, opportunities for NBT-XR3 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 NBT-XR3 in pancreatic ductal adenocarcinoma and the principal investigator shared positive preliminary qualitative efficacy data in the fourth quarter of 2022. 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 the dose expansion phase gets underway, a borderline respectable patients become eligible for an enrollment alongside locally advanced patients evaluated in the dose escalation phase. In addition to the upcoming data expected from pancreatic trial, MD Anderson has made significant progress in its phase one trial of NBT-XR3 in non-small cell lung cancer and expect to determine a recommended phase two dose in this study in the second half of this year. As you recall, They are also leading a phase 1 trial of NBT-XR3 in combination with chemotherapy for patients with esophageal cancer and are progressing toward an anticipated recommended phase 2 dose in 2024. Given their shift toward proton therapy in treating this patient, the study presents an interesting opportunity to validate prior preclinical data suggesting the safety and potential benefit of combining NBT-XR3 with proton therapy, which theoretically offer a reduction in the radiation exposure to healthy neighboring tissue wise improvement of the therapeutic ratio. MD Anderson is in the process to modify the existing protocol to allow for introduction of proton therapy for a cohort of patients in this study. At this juncture, we anticipate the study team reaching a recommended phase two 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. Finally, I would like to highlight that we have many value inflection point, see here in the coming 12, 24 months across all of our program. We believe that NBT-XR3 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. I would like now to turn the call to Bart to briefly discuss our financial results for the period. Bart?