Nanobiotix S.A. (NASDAQ:NBTX) Q1 2022 Earnings Conference Call May 19, 2022 8:00 AM ET Company Participants Kate McNeil ??? Senior Vice President, Investor Relations Laurent Levy ??? Co-Founder and Chief Executive Officer Bart Van Rhijn ??? Chief Financial Officer Conference Call Participants Lucy Codrington ??? Jefferies Michael DiFiore ??? Evercore Cl??ment Bassat ??? Portzamparc RK Swayampakula ??? H.C. Wainwright Fr??d??ric Gomez ??? Pharmium Securities Operator Good day, and thank you for standing by. ...

Financial Performance - The company incurred net losses of €47.0 million for the year ended December 31, 2021, and anticipates continuing to incur significant losses for the foreseeable future[45]. - The company has not generated significant revenues from product sales or royalties and relies primarily on payments from collaboration agreements and research tax credits[45]. - The company has incurred significant operating losses since inception, primarily due to expenditures on developing nanotechnology and clinical programs[45]. - The company anticipates that its expenses and capital requirements will increase substantially as it progresses its clinical and preclinical programs[45]. - The company may require additional funding to continue its operations and product development, which may not be available on acceptable terms[60]. - The company faces restrictions from the EIB loan covenants that limit its operational flexibility and ability to raise additional financing[66]. - The company may need to seek additional capital sooner than planned due to changing operational needs and market conditions[61]. - The company recognizes that unfavorable outcomes in clinical trials could materially affect its business and financial condition[72]. Product Development and Regulatory Challenges - The successful development and commercialization of the lead product candidate, NBTXR3, is critical for the company's future success and market opportunities[46]. - NBTXR3 has received CE marking for the treatment of locally advanced STS, enabling commercialization in the EU, but remains in clinical development for other indications[47]. - The company must navigate a complex regulatory framework that could impact the development and approval of its product candidates[38]. - The company is prioritizing the development of NBTXR3 for head and neck cancers in the US and EU, with no assurance of receiving FDA approval or completing conformity assessment procedures in the EU[93]. - The company is conducting clinical trials for NBTXR3 across eight cancer indications, with a collaboration involving approximately 340 patients with MD Anderson[68]. - The company expects delays in clinical trial activities due to COVID-19, including recruitment and monitoring challenges[54]. - Regulatory authorities impose stringent requirements that can increase the cost and complexity of obtaining marketing authorizations, potentially limiting the economic value of new products[89]. - The company is subject to stringent regulatory requirements, including post-marketing studies and compliance with safety and efficacy monitoring[125]. Competition and Market Risks - The company faces significant competition from other entities with greater financial and technical resources, which may impact its ability to develop and commercialize products[48]. - Government restrictions on pricing and reimbursement may negatively impact the company's ability to generate revenues even after successful regulatory approvals[95]. - The potential for future healthcare reforms may lead to more rigorous coverage criteria and lower reimbursement rates, impacting commercialization prospects[104]. - The pricing of therapeutic products in foreign markets is subject to government control, which may limit favorable reimbursement arrangements[105]. Manufacturing and Supply Chain - The company is heavily dependent on third parties for the supply of materials necessary for production, which poses risks to its product development timelines[38]. - The company opened a new manufacturing facility in Villejuif BioPark, France, to expand production capacity for NBTXR3[117]. - The company is dependent on third parties for raw materials, and any supply interruptions could significantly compromise product development[115]. - The company must ensure that third-party manufacturers comply with safety protocols, as any interruption in nanoparticle production could compromise product development efforts[78]. Intellectual Property and Legal Risks - The company relies on both patent protection and trade secrets to safeguard its proprietary technology, but the effectiveness of these protections is uncertain[158]. - Legal actions to enforce patent rights can be costly and may divert management's attention, potentially harming the company's competitive position[156]. - The company may face challenges in obtaining and maintaining a robust patent portfolio, which is essential for its commercial success[152]. - The complexity of patent laws and potential challenges to patents could negatively impact the company's competitive position in the oncology therapeutic market[161]. - The company may face ownership disputes regarding intellectual property developed through collaborations, which could limit its ability to capitalize on market potential[174]. Employee and Operational Risks - The company currently has 100 full-time employees and plans to increase this number to support development and commercialization efforts[131]. - The company may face significant costs and operational challenges in establishing its own sales, marketing, and distribution capabilities[130]. - The company is exposed to risks related to employee misconduct, which could lead to regulatory sanctions and reputational harm[137]. - The company may encounter difficulties in managing its expansion, which could disrupt operations and increase expenses[131]. Shareholder and Market Considerations - The company does not currently intend to pay dividends on its ordinary shares, focusing instead on reinvesting future earnings for growth[181]. - As of December 31, 2021, the company had 34,825,872 ordinary shares outstanding, with potential sales by existing shareholders possibly depressing market prices[187]. - Holders of ADSs may experience dilution in their holdings due to limitations on preferential subscription rights and dividend options[191]. - U.S. investors may encounter difficulties in enforcing civil liabilities against the company and its management due to their non-resident status[208]. Compliance and Regulatory Environment - The company is classified as an "emerging growth company" and intends to utilize exemptions from certain reporting requirements until it no longer qualifies[194]. - A material weakness in internal control over financial reporting was identified prior to the issuance of interim financial statements for the six months ended June 30, 2021[197]. - The company remediated the identified material weakness in internal control over financial reporting during the year ended December 31, 2021[198]. - The company is in the process of implementing critical actions suggested by external experts to comply with GDPR requirements[150]. Foreign Investment and Exchange Risks - The company is exposed to foreign exchange risks, particularly as it incurs expenses in U.S. dollars while generating revenue in euros[215]. - An increase in the euro's value against the U.S. dollar could negatively impact revenue and earnings growth, as U.S. dollar revenues would be translated into euros at a reduced value[216]. - The company currently does not engage in hedging transactions to protect against future exchange rate fluctuations[215]. - Non-French investors may require prior governmental authorization for investments in French entities, particularly in strategic industries like biotechnology[229].

Financial Data and Key Metrics Changes - Total revenue for 2021 was approximately €10,000, a decrease from €50,000 in 2020 [17] - Other income increased from €1.9 million in 2020 to €2.5 million in 2021 due to higher research and development expenses [18] - Research and development expenses rose to €30.4 million in 2021 from €24.3 million in 2020, reflecting increased clinical trial costs [19] - Selling, general and administrative expenses increased to €19.4 million in 2021 from €14.6 million in the prior year, with a significant decrease in SG&A during the second half of 2021 [20] - Net loss for 2021 was €47 million, compared to a net loss of €33.6 million in 2020 [21] - Cash, cash equivalents, and investments totaled €83.9 million at the end of 2021, down from €119 million at the end of 2020 [22] Business Line Data and Key Metrics Changes - The company is focusing on two lead programs: NBTXR3 as a single agent activated by radiation in head and neck cancer, and a follow-on checkpoint inhibitor combination program [9] - A new strategic partnership with LianBio was established to advance NBTXR3 development in Asia, with LianBio expected to enroll 20% of the 500 patients in the pivotal study [12][13] Market Data and Key Metrics Changes - The company anticipates patient enrollment in the pivotal study to begin in the second half of 2022, with ongoing collaborations expected to enhance development capabilities [13][34] Company Strategy and Development Direction - The company aims to optimize capital allocation and enhance operational efficiency while focusing on the development of NBTXR3 [11][23] - The strategic priority is to advance the Phase III trial in head and neck cancer and explore registration pathways for the immune checkpoint inhibitor combination [50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of NBTXR3 to provide survival benefits in patients intolerant to standard chemotherapy [26] - The company is actively working with the FDA to define a registration path for NBTXR3 in combination with immune checkpoint inhibitors, with encouraging preliminary feedback [44][60] Other Important Information - The company has strengthened its leadership team with key appointments to drive execution and foster a culture of innovation [15][16] - Ongoing collaborations with MD Anderson have generated significant preclinical data supporting the combination potential of NBTXR3 with immune checkpoint inhibitors [14] Q&A Session Summary Question: What is the status of the 312 study? - The 312 study is progressing well, with sites initiated in Europe and patient injections beginning in January [48] Question: What is the status of non-priority pathways, including liver and prostate studies? - The priority remains on the Phase III trial in head and neck cancer, with other trials opening new growth opportunities [50] Question: What is the company's cash position and financing prospects? - The company is evaluating options for sufficient capital and has initiated cost optimization programs [55][56] Question: What are the key upcoming data releases? - Key data releases include updates from the rectal cancer and head and neck chemotherapy studies expected in Q2 [58] Question: What is the expected timeline for discussions with the FDA regarding immunotherapy? - Discussions with the FDA are ongoing, focusing on clarifying endpoints and population for market entry [65] Question: What is the status of the Curadigm and CNS platforms? - Development of Curadigm is ongoing in collaboration with Sanofi, while CNS platform development is progressing at a preclinical stage [68]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ________________________ FORM 20-F ________________________ (Mark One) o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December, 31 2020 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from __________ to _ ...