Nanobiotix S.A.

Good day and thank you for standing by. Welcome to the Nanobiotics Business Update and First Half 2023 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a Q&A session. Please be advised that today's conference is being recorded. At this point, I'd like to turn the call over to Craig West, Senior Vice President of Investor Relations of Nanobiotics.

Thank you, Operator. Good afternoon and good morning, and welcome to the Nanobiotics Conference Call to discuss our first half 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. 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 SEC in the United States, including the RFS and 6K 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, Nanobiotix 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. As Greg mentioned, we issued a press release yesterday highlighting the company's first half to 2023 operating activities and financial results. For today's call, I will begin with an overview of our accomplishments and review upcoming milestones for each of our programs. Bart, our chief financial officer, will follow up with financial updates. I will then give closing remarks before opening the call for questions. The first half of this year has been truly transformative for nanobiotics, following the successful completion of a global license agreement with Jensen, the appointment of Dr. Kayitalire, an industry veteran in oncology as chief medical officer, and the ongoing advancement of trials designed to establish the clinical foundation of NBT-XR3 in multiple solid tumor indications. I'm very proud of what the company has accomplished in the past months. Collectively, this achievement continues to propel late-stage development of NBT-XR3 forward, expand our patient reach, and ultimately position us to realize the paradigm-changing potential of NBT-XR3 worldwide. We're very excited about the recent global licensing, co-development, and commercialization agreement with Jensen Pharmaceutica, one of the Jensen Pharmaceutical Company of Johnson & Johnson, for NBT-XR3, our potential first-in-class radioenhancer. This partnership is designed to leverage the strength of both companies and accelerate and broaden the treatment potential of NBT-XR3. As part of the agreement, the initial focus of clinical development will be on the head and neck and lung cancers, with expansion potential in additional solid tumor indication. We believe this partnership underscores the therapeutic and market opportunities of NBT-XR3 and, importantly, further validates our platform and our scientific approach. What we find particularly attractive about this deal is that it offers both near-term and long-term value for shareholders, including access to up to 60 million in the near-term support, up to 30 million in equity, subject to certain conditions, and success-based payment of over 1.8 billion in development, regulatory and sales milestones. Additional success-based milestone payments of up to $615 million are available for indications that may be developed by Jensen at its sole discretion, and up to $220 million for indications that may be developed by nanobiotics in alignment with Jensen. Beyond milestones, this also includes tiered about-digit sales royalties and product manufacturing and supplies. Recently, we received shareholder approval for Johnson & Johnson Innovation to become a strategic investor of nanobiotics, with an initial tranche equal to $5 million. Bart will go through the details more in depth shortly. But we are pleased this deal has helped strengthen our balance sheet and extend our cash runaway into the first quarter of 2024, including through some key clinical catalysts. We believe we selected the best possible strategic partner in Janssen, a premier oncology leader with global reach and proven experience in pharmaceutical and medical technology. At Nanobiotix, we will continue to focus on the development of MBTX artery, continue our manufacturing expertise and serve as the innovation engine. Janssen will contribute its substantial development support, regulatory and commercial capabilities. We believe Janssen regulatory and commercialization experience combined with nanobiotics capabilities and know-how in nanophysics will help us to achieve our shared objectives. We are well underway getting the collaboration started and we look forward to the potential to bring in life-changing treatment for patients around the world. As we work to build the next chapter of nanobiotics, NSM's clinical development and commercialization of NBT-XR3, We are pleased to welcome industry veteran Dr. Louis Kayitalire to our executive leadership team at this pivotal time. Louis brings an exceptional biopharmaceutical industry track record with proven success in development, registration, and commercialization of oncology therapeutics. His seasoned, innovative leadership will be invaluable as we focus on maximizing the disruptive potential of our radioenhancer for millions of patients cancer around the world. We look forward to working together as we prepare for registration and further optimization of our pipeline. Now let's turn to our clinical programs. As a reminder, more than 60% of all solid tumor cancer patients will receive radiation therapy during their treatment. This presents a large opportunity for NBT-XR3, which is a single treatment designed to enhance outcome alone or in combination with standard of care and, importantly, easily integrate into existing medical practice. The significant clinical evidence across multiple indications today has shown NBT-XR3 to be well tolerated with consistent, encouraging activity in the range of solid intubos. Our ongoing clinical program evaluating MBT-XR3 for the treatment of solid tumors continues to progress well, including our nanobiotic-sponsored programs in head and neck and our MD Anderson partner program exploring expansion opportunities in pancreatic cancer, esophageal cancer, non-small cell lung, and head and neck cancer. Importantly, we expect multiple potential value inflection points in the next 12 to 24 months. Our last-stage efforts for MBT-XR3 are advancing, with our ongoing pivotal Nanorad 312 global randomized phase 3. This trial evaluates radiotherapy-activated MBT-XR3 with and without cetuximab compared to radiotherapy alone with and without cetuximab in patients with locally-advanced head and neck cancer that are ineligible for cisplatin chemotherapy. We remain on track to report the interim efficacy for NanoRay 312 after 67% of planned events in the second half of 2024. The futility analysis conducted following 25% of planned events is expected in the first half of 2024. For study 102, a phase 1 dose escalation and expansion trial in patients ineligible for cisplatin chemotherapy or intolerant to cetuximab, we expect to present safety and efficacy data at a medical meeting in the coming weeks. This data from study 102 in a similar indication as manual array 312 will help to inform on our phase 3 ongoing trial. We are also pursuing lead-stage potential for radiotherapy-activated plus immunotherapy combination approach, which is designed to initially prime the immune system and improve the efficacy of checkpoint inhibitors. We anticipate providing a phase 1 data update between now and the first half of 2024. For potential phase 3 registrational program in patients with recurrent or metastatic head and neck cancer, that are resistant to previous NTPD1 PD-L1 therapy, we are in consultation with our newly appointed CMO and with our partner on what next steps should be for this program. Ongoing exploration of expansion opportunity for NBTX artery as part of our strategic collaboration with the University of Texas MD Anderson Cancer Center continues to be promising and includes five ongoing trials in advanced solid tumor. We believe this trial can help lay the clinical foundation and provide proof-of-concept support for additional indications that are de-risked with demonstrated clinical therapeutic potential for NBT-XR3. In July, the first patient was injected in the newest MDA-lead study, a Phase I-II study evaluating radioterapy activated in combination with an anti-PD-L1 immune checkpoint inhibitor in patients with absent solid tumor with lung or liver metastasis. We will present preliminary phase 1 dose escalation safety data at a medical conference in the coming weeks in pancreatic cancer. In addition to the planned upcoming data for pancreatic trials, MD Anderson has made significant progress in its phase 1 trial of NBT-XR3 in operable non-small cell lung cancer and expect to determine a recommended phase 2 dose for this product in the second half of this year. As you recall, MD Anderson is also leading a phase 1 trial of MBT-X-Artery in combination with chemotherapy for patients with esophageal cancer, where initial data are expected in 2024. We believe this multiple value inflection point in the coming 12-24 months will further support the potential of MBT-X-Artery to deliver treatment benefits and enhance the utility of standard of care like radiation and immunotherapy in many solid tumors. With that, I would like now to turn the call over to Bart to briefly discuss our financial results for the period. Bart?