Nanobiotix S.A.

Good day and thank you for standing by. Welcome to the Nanobiotics First Quarter Operational and Financial Update. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded Thursday 19th May 2022. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Kate McNeil. Please go ahead.

Thank you, Operator. Good afternoon and good morning, and welcome to Nanobiotics Conference Call to discuss our first quarter 2022 financial and operational 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'd 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 presentations, 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, your caution 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 file with the AMF in France and SEC in the United States. including our most recent URD and 20F, 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 on Kansas 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 update them to reflect subsequent events or future circumstances. With that said, I'd like to turn the call over to Laurent. Laurent, please go ahead.

Thank you, Kate. I would like to welcome everyone participating via conference call and webcast today. As Kate mentioned, we issued a press release yesterday, not only highlighting the company's first quarter operating activities, but also identifying some of the key changes taking place at Nanobiotics. Before we open the call for Q&A, I would like to take a moment both to touch on our progress and outline how we plan to move forward to optimize our operational activities to advance the development of NBT-XR3 and drive shareholder value in the near and long term. Our strategy has been focused on three key development priorities. One, securing initial U.S. approval of NBT-XR3 as a treatment for locally advanced head and neck cancer. Developing NBT-XR3 in combination with NTPD1 therapy as a treatment for advanced cancer and foundation for immunotherapy treatment. And three, leveraging our strategic collaborations to advance and expand the potential profile of NBT-XR3 in additional cancer indication, both as a single agent and combination therapy. Our fundamental strategy remains unchanged. And during the first quarter of 2022, we've made significant progress toward this goal. The most significant milestone was, of course, the randomization of the first patient in our pivotal phase three trial in head and neck cancer. This achievement reflects the extraordinary commitment, dedication, and hard work of the entire naturopathic team and the tremendous support of investigators and patients. While there is a considerable work ahead, we remain driven by our belief in the potential benefit of NBT-XR3 and look forward to continuing our efforts to secure approval and fulfill a critical need for patients. The second truly significant advancement during the first quarter relates to our immune oncology combination program. This program has been exciting From the start and the data from the ongoing study 1100 evaluating NBT-XR3 in combination with NTPD-1 therapy has suggested NBT-XR3 may be a potent immunostimulant capable not only of enhancing response to NTPD-1 treatment for those that already benefit from treatment, but also overcoming primary and secondary resistance to NTPD-1 treatment for many more that do not. The data generated by this program, combined with the potentially transformative benefit for patients, has increased our sense of urgency to identify an appropriate and expedient path to market. In particular, we believe that given the historically low overall response rate to NTPD1 treatment and the significant number of patients that demonstrate either primary or secondary resistance to therapy, pursuing a registration program targeting patients with recurrent or metastatic head and neck cancer who have developed primary or secondary resistance to anti-PD-1 therapy addresses the area of highest and net medical need. And last year, we initiated a dialogue with FDA regarding a potential registration program in this indication. While we have not yet submitted a full protocol for FDA review, We have received preliminary written comment from the agency suggesting that a single controlled trial including a pre-specified comparative analysis on overall response rate may be suitable to support accelerated approval with verification of clinical benefit based on overall survival results from the same trial. Given the consistently high overall response rate we have seen across our clinical trial, including study 1100, in which only one patient has experienced progressive disease following administration of our product in combination with PEMBRO or NEVO, we are encouraged by the opportunity this could represent to accelerate development of NBT-XR3 in combination with IO and define an attractive path to registration in an area of significant unmet need. Over the next several months, we will be working to develop a final protocol informed by the data generated from our ongoing study and in line with the guidance received to date. We currently expect to submit this protocol to the FDA for review early next year. Finally, in addition to this advancement in our Single Agent and Combination Program, our partners, MD Anderson continued to advance their research and reported the first case study on safety and feasibility of NBTX artery in pancreatic cancer. As we all know, pancreatic cancer continues to be a devastating and incredibly challenging disease to treat. And we are encouraged by the success of this program so far and really look forward to the completion of this dose escalation study later this year. As each of these accomplishments suggests, Nanobiotics has made substantial progress against its fundamental strategic goal and has a clear line of sight to multiple significant potential value drivers for the business. However, as each of us knows, the pressure of the biotech sector remains and prolonged volatility in the financial market appears likely. While the current conditions of the capital market do not change our fundamental value proposition, they do require us to apply the same innovative thinking to our corporate finance and development strategy as we have applied to the creation of NBT-XR3. In this regard, we are exploiting the inherent flexibility of our pipeline and adapting our current development plans to maintain targeted research effort focused on the continued execution of our ongoing pivotal phase III study in locally advanced head and neck cancer, along with the continuation of our higher combination study 1100 and the development of the registration path from IO combination therapy. Having validated the novel physical mechanism of action of NBT-XR3 and produced a portfolio of preclinical and clinical evidence supporting the potential safety, feasibility, and efficacy across multiple indication and therapeutic combination, we are well positioned to focus our effort on building an initial franchise focused on the treatment of head and neck cancer. with the confidence that this result achieved will build a solid foundation for future expansion. In prioritizing late-stage programs and strategic collaboration, the company plans to de-prioritize direct funding in several areas, including modifying or postponing additional company-sponsored clinical trials that are not required to advance a priority pathway. This includes delaying post-marketing study previously planned to support or see a mark in soft tissue sarcoma as well as modifying the protocol from study 102 to allow for a reduction in post-treatment follow-up from 24 months to 12 months. Adjustment to study 102 will meaningfully reduce costs associated with the study without materially impacting the value generated by this program. As you will recall, study 102 is fully enrolled and all the patients have completed treatment. In fact, most of the patients will have reached the 24-month follow-up at the time we will stop the trial. Based on this modification, we expect to provide top-line data from Study 102 in mid-2023. In parallel to changes, in our clinical program, we will be reducing ongoing and previously planned preclinical research, including development activities related to the company's subsidiary, Curadagme. In addition to the cost savings afforded by the planned reduction in near-term clinical and preclinical activity, these changes also allow us to make corresponding adjustments to our manufacturing activities and leverage our existing clinical supplies to support our ongoing program and further reduce our near-term expenses. Finally, two years of operating in a pandemic has changed how all of us do business, and nanobiotics is no exception. We acted quickly to adjust operational infrastructure to accommodate remote work and promote connectivity across the global footprint. At this time, we can further leverage that efficiency and innovation by reducing satellite office facilities to generate further savings while retaining our primary offices and manufacturing facilities in Paris. In addition to a planned reduction in our physical footprint, and in light of planned adjustment to our development program, we are delaying any expansion of our team until operational needs and circumstance warrant. I would now like to turn the call over to Bart, who will address additional measures we are taking to extend our runaway and strengthen our financial flexibility. Bart? Thank you, Laurent.