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Nanobiotix S.A.
3/31/2022
Good afternoon and good morning, and welcome to Nanobiotics Conference Call to discuss our 2021 Full-Year 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, collaboration, regulatory filing, 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're 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 file with the AMF in France and the SEC in the United States, including the URD and 20F filed in their last version, 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. Laurent, please go ahead.
Thank you, Kate. I would like to welcome everyone participating via conference call and webcast today. This is a busy and exciting time at Nanobiotics, and I'm pleased to have this opportunity to highlight some of the important progress our team has made in the past year, provide some additional insight as what we expect in this year, and why we continue to be excited by the potential of our lead product candidate, NBTXR3. As we outlined in January, our priorities for 2022 include focusing our internal development efforts on our two lead programs, including the execution of 312, Our global pivotal study of NBT-XR3 as a single agent activated by radiation in locally advanced head and neck cancer patients. And two, the advancement of our follow-on checkpoint inhibitor combination program seeking to expand the treatment benefit of NTPD-1 therapy. In parallel, we will continue to leverage our existing key collaboration to advance and expand our pipeline while we evaluate potential new collaboration that could contribute complementary development and or commercial capabilities. As we continue to expand our operating efficiency and carefully align our resources with the strategic priorities supported by BAR and the rest of the leadership team, we seek to both maximize and deepen our operational expertise in key functional areas to support our continued growth. During 2021, we took several key operational steps to position us to build the foundation of future opportunity and achieve this goal in 2022. In May 21, we added a new strategic partner, Lian Bio, to advance and expand the development of MBT-XR3 in Asia. We are pleased to have found a partner that is committed to revolutionize patient outcomes, share our strategic vision for MBT-XR3, and bring substantial regional expertise that should enable a meaningful contribution to our global development initiatives. YoungBio will be a key partner for us in our head and neck registration study, enrolling 20% of the 500 patients we plan. Preparation for this are already well underway, and we'll currently expect YoungBio to initiate patient enrollment in STD 312 in the second half of 2022. In addition, YoungBio has committed to participate to four additional registrational studies with MBJXR3 across syndication, and therapeutic combination, funding all the development and commercialization expenses in their territory, highlighting their belief in and commitment to the broad potential of MDT-XR3. This commitment to the long-term vision for MDT-XR3 mirrors that of our ongoing work with MDUnderstand. We've been engaged in a broad collaboration with MDUnderstand since 2018. Their research and development support has already generated robust library of preclinical data, particularly around the combination potential of NBT-XR3 with immune checkpoint inhibitor, this resulting in multiple presentation and publication. In 2021, MD-Undersun initiated the fifth clinical trial with NBT-XR3 under its collaboration, which now includes three phase one studies, exploiting the safety and feasibility of NVTX artery in pancreatic cancer, in esophageal cancer, and non-small cell cancer. And additionally, two Phase II studies exploring the potential efficacy of NVTX artery in combination with immunotherapy, this in head and neck. Having already reported the first patient case study from MD Anderson Phase I pancreatic study, anticipate the dose escalation of that study to reach its target, recommended Phase II dose later this year. Similarly, MD Anderson phase 1 study of MBCS-SAR3 in combination with chemo is also expected to report recommended phase 2 dose in 2022. In addition to expanding our external development capabilities, we also significantly strengthen our leadership team with the appointment of Gary Phillips as chairman of our supervisory board, bringing decades of experience in the pharmaceutical and healthcare industry, and Bart Van Ryn, as our Chief Financial Officer bringing proven capabilities in global financial management, business development, and pharmaceutical commercialization. More recently, we were pleased to welcome Dr. Len Farber, a board-certified medical oncologist, as our new Chief Scientific and Medical Affairs Officer, adding extensive executive experience in developing and growing treatment centers and departments within the radiation oncology field. Each of these individuals had already had a tremendous impact on the company, driving execution across key programs and contributing to a culture of innovation, integrity, and inclusion, while fostering transparency and accountability. Now, before I turn our attention to the results and expectations for internal development before, I would like to ask Bart to provide a brief review on our financial results. Bart?
Thank you, Laurent. As Kate mentioned, yesterday after the close of the US markets, Nanobiotics reported financial results for the year ended December 31st, 2021, while highlighted our financial position as well as our recent progress. As described in the release, our total revenue, consisting primarily of revenue related to our prior collaboration with PharmaEngine, totals approximately €10,000, compared to €50,000 for the year ended December 31st, 2020. All our income for the period includes research tax credits, which increased from €1.9 million in 2020 to €2.5 million in 2021 due to an increase in research and development expenses. Our research and development expenses for the year were €30.4 million compared to €24.3 million for the year ended December 31, 2020. This increase reflects the increased clinical trial development costs related to the company's priority pathways, including preparation and initial site activation for our pivotal phase three registration study, NanoRay 312, and our immunotherapy combination study, 1100. Selling, general, and administrative expenses were 19.4 million euro for year-ended December 31st, 2021, compared to 14.6 million euro for the prior year period. This year-over-year increase was related to a change in headcount mix and geography, recruitment expenses, and expenses resulting from the NASDAQ listing, and reflects a significant decrease in SG&A during the second half of 2021, a trend that is expected to continue year-over-year in 2022. Metabiotics net loss was €47 million for the year, compared to a net loss of 33.6 million euro for the 2020 fiscal year, which includes 5.4 million euro in auto operating income and expenses related to the termination of the pharma engine agreement in early 2021 and financial income of 5.6 million euro driven by currency translation gains. We ended the year with cash, cash equivalents and investments totaling 83.9 million euro compared to the €119 million as of December 31, 2020. This net decrease of €35.3 million reflects €51.8 million of net cash flows used in operating, investing, and financing activities of nanobiotics, which was partially offset by the €16.5 million, or US$20 million, upfront payment associated with the LiamBio collaboration announced in May 2021. Finally, as we continue to optimize our capital allocation and drive ever-increasing efficiencies and flexibility in our cost structure, we anticipate that our cash, cash equivalents, and multiple securities as of December 31st, 2021 should enable us to fund operations well into the second quarter of 2023. And now I'll turn the call back to Laurent to discuss these programs in further detail. Thank you, Bart.
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