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Nanobiotix(NBTX) - 2023 Q4 - Annual Report
2024-04-24 20:49
EXHIBIT 99.1 NANOBIOTIX Provides Business Update and Reports Full Year 2023 Financial Results Conference call and webcast scheduled for April 25, 2024 at 8:00 A.M. EDT / 2:00 P.M. CEST PARIS and CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the "Company"), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, provided an update on operational progress and reported financia ...
NANOBIOTIX Provides Business Update and Reports Full Year 2023 Financial Results
Newsfilter· 2024-04-24 20:40
Global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV ("Janssen") expands worldwide potential of novel radioenhancer NBTXR3Prolonged survival in Study 102 reinforces pivotal NANORAY-312 trial design in head and neck cancer; initial efficacy and favorable safety profile supports potential of NBTXR3 in pancreatic cancer; determined RP2D for MD Anderson lung studyMultiple clinical readouts expected in 2024 including immunotherapy combination data from Study 1100, and d ...
Nanobiotix(NBTX) - 2023 Q4 - Annual Report
2024-04-24 20:23
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, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from __________ to _ ...
Nanobiotix(NBTX) - 2022 Q4 - Annual Report
2023-04-24 21:15
Financials and Expenditures - Capital expenditures for 2020, 2021, and 2022 were €0.08 million, €1.6 million, and €0.5 million respectively, with expectations for increased expenditures in 2023[311]. - The company plans to expand its manufacturing capabilities in 2024 to support clinical trials and initial commercialization of NBTXR3[488]. - The company has not yet established commercial infrastructure in the US or EU and is defining its commercialization strategy[489]. Clinical Trials and Studies - NBTXR3 demonstrated a statistically significant improvement in pathological complete response, with approximately twice as many patients achieving this outcome compared to those receiving radiotherapy alone[321]. - The median overall survival for patients in the Phase 1 trial of NBTXR3 was reported at 23 months, showing continued improvement in outcomes[322]. - The NANORAY-312 Phase 3 trial aims to enroll approximately 500 patients, focusing on elderly patients with locally advanced head and neck squamous cell carcinoma[323]. - NBTXR3 has been administered to over 300 patients as of December 31, 2022, indicating significant clinical engagement[328]. - Nanobiotix is conducting Study 1100, a Phase 1 multi-cohort trial of RT-activated NBTXR3 followed by anti-PD-1 checkpoint inhibitors in patients with recurrent or metastatic head and neck squamous cell carcinoma[334]. - The company is conducting a Phase 2/3 trial (Act.In.Sarc) to measure the anti-tumor activity of NBTXR3 activated by radiotherapy in patients with locally advanced STS[368]. - The NANORAY-312 trial includes stratification factors such as investigator's choice of cetuximab addition, HPV status, and age-adjusted Charlson Comorbidity Index[389]. - The study aims to evaluate safety and tolerability of NBTXR3, with secondary endpoints including overall response rate, local progression, and quality of life[394][387]. - The ongoing Phase 1 trial (Study 1100) aims to evaluate the safety and efficacy of RT-activated NBTXR3 followed by anti-PD-1 checkpoint inhibitors in approximately 141 evaluable patients[434]. - The ongoing dose expansion part of the study is evaluating RT-activated NBTXR3 plus anti-PD-1 in patients with LRR or R/M HNSCC[446]. Mechanism of Action and Technology - NBTXR3 is designed to enhance the efficacy of radiotherapy by increasing localized tumor cell death without harming surrounding healthy tissues[314]. - NBTXR3 nanoparticles are designed to enhance the efficacy of radiotherapy by increasing the absorption of radiation within malignant tumors without causing additional damage to surrounding healthy tissues[344]. - The technology utilizes nanoparticles with a high electron density core of crystallized hafnium oxide, which allows for greater energy absorption during radiotherapy[345]. - The company believes that NBTXR3 could improve systemic treatment outcomes by enhancing the effectiveness of immune checkpoint inhibitors in patients[332]. - Preclinical data indicated that RT-activated NBTXR3 may enhance the immune response, potentially converting "cold" tumors into "hot" tumors[423]. Market Potential and Collaborations - Approximately 60% of cancer patients in developed countries receive radiotherapy, highlighting a substantial market opportunity for NBTXR3[315]. - The company aims to build a treatment franchise for head and neck cancer, where 74% of patients are expected to receive radiotherapy, representing a significant market potential[319]. - The company has established a collaboration with LianBio to develop and commercialize NBTXR3 in key Asian markets, including Mainland China, Taiwan, and South Korea[328]. - The company has entered into a collaboration with MD Anderson to support multiple clinical trials involving approximately 312 patients[361]. - The company has terminated its collaboration with PharmaEngine, regaining all rights to NBTXR3 in the Asia-Pacific region[472]. Regulatory Designations and Approvals - NBTXR3 received Fast Track designation from the FDA in February 2020 for the treatment of locally advanced head and neck cancers[333]. - The company received Fast Track designation from the FDA for NBTXR3 for treating locally advanced head and neck cancers not eligible for platinum-based chemotherapy[391]. - NBTXR3 has received CE mark approval for commercialization in the EU for the treatment of locally advanced STS of the extremities and trunk wall under the brand name Hensify[376]. Patient Outcomes and Efficacy - NBTXR3 nanoparticles demonstrated a pathological complete response rate of 16.1% in the treatment arm compared to 7.9% in the control arm, achieving statistical significance with a p-value of 0.0448[370]. - In patients with higher histology grades, the pathological complete response was achieved in 17.1% of the NBTXR3 arm versus 3.9% in the control arm[371]. - The rate of tumor surgery with R0 margins was 77% in the NBTXR3 arm compared to 64% in the control arm, with a p-value of 0.0424 indicating statistical significance[373]. - The five-year survival rate for patients with locally advanced head and neck cancers is estimated at 68%[378]. - Approximately 54,000 patients were diagnosed with oral or oropharyngeal cancer in the United States in 2022, with an estimated 11,230 deaths from the disease[378]. - Among evaluable patients with oropharyngeal head and neck cancer, the objective response rate was 100%, with 66.7% achieving complete response and 33.3% partial response[405]. - The median overall survival (mOS) for evaluable patients was 18.1 months, while the median progression-free survival (mPFS) was 10.6 months[406]. - In the "all patients treated" population, the mOS was 14.1 months, with 63% of patients having a modified Charlson Comorbidity Index (mCCI) of four or more, indicating a higher risk of early death[408]. - As of February 22, 2022, the mOS improved to 17.9 months in the all treated population and 23.0 months in evaluable patients[411]. Intellectual Property and Patents - The company holds over 450 issued or pending patents across 23 patent families related to NBTXR3 technology and nanomedicine applications[498]. - The company holds 73 patent families related to its technologies, with expiration dates ranging from 2025 to 2041[499]. - The company relies on trade secrets to protect proprietary technologies and maintains confidentiality agreements with employees and consultants[507]. - The patent family for NBTXR3 includes applications for its use in immuno-oncology and in combination with other checkpoint inhibitors[505]. - The company has patent applications pending in multiple countries, which may affect the expiration dates of certain patents[502]. - The company has a diverse geographical patent coverage, including countries such as the United States, Canada, Australia, and various European nations[499][500].
Nanobiotix(NBTX) - 2022 Q3 - Earnings Call Transcript
2022-11-11 16:12
Nanobiotix S.A. (NASDAQ:NBTX) Q3 2022 Earnings Call Transcript November 10, 2022 8:00 AM ET Company Participants Kate Mcneil - Senior Vice President, Investor Relations Laurent Levy - Co-Founder & Chief Executive Officer Bart Van Rhijn - Chief Financial Officer Conference Call Participants Mike DiFiore - Evercore Cl??ment Bassat - BNP Paribas Kate Mcneil Thank you, operator. Good afternoon and good morning, and welcome to Nanobiotix Conference Call to discuss our Third Quarter 2022 Financial and Operational ...
Nanobiotix(NBTX) - 2022 Q2 - Earnings Call Transcript
2022-09-29 18:08
Financial Data and Key Metrics Changes - The operating costs for the first half of 2022 decreased from €31.1 million in 2021 to €27.2 million in 2022, reflecting a reduction in SG&A expenses and an increase in R&D expenses due to the initiation of a global Phase 3 study [28] - The net loss attributable to common shareholders for the first half of 2022 was €26.4 million, or €1.76 per share, compared to a net loss of €30.4 million for the same period in 2021 [29] Business Line Data and Key Metrics Changes - Significant progress was made in the clinical program, particularly with the initiation of patient enrollment in NANORAY-312, which is now actively recruiting patients across Europe, the U.S., and Asia [10][12] - Enrollment was completed in Study 102, which provided valuable information regarding the activity of NBTXR3 in head and neck cancer, leading to a decision to pursue registration in this area [14] Market Data and Key Metrics Changes - Approximately 50 clinical sites have been activated across 13 countries for NANORAY-312, with recruitment ongoing in key territories [9][10] - The company is facing challenges due to the COVID-19 pandemic, including staffing shortages in the U.S. and a recent surge in cases in China, but has adapted its strategies accordingly [12] Company Strategy and Development Direction - The company is focused on advancing the development of NBTXR3, particularly for patients with local events and treatment-resistant recurrent and metastatic cancer [7][8] - Plans include leveraging existing data to support the development of a Phase 3 protocol submission to the FDA by Q1 2023 [20][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate challenges and emphasized the importance of the NANORAY-312 study as a key operational priority [31] - The company anticipates that it will take approximately four to six months of global recruitment to provide data-driven validation of study timelines [13] Other Important Information - The company has implemented cost control initiatives aimed at achieving a double-digit reduction in SG&A expenses and has restructured existing debt obligations to align repayment schedules with anticipated commercial timelines [22][23] - As of June 30, 2022, the company reported €63 million in cash and cash equivalents, expected to support clinical development programs into Q1 2024 [26] Q&A Session Summary Question: Efforts to extend cash runway - Management acknowledged the progress made in extending the cash runway potentially into 2024 and discussed ongoing internal and external initiatives to drive efficiency [34][35] Question: Data readouts for Study 1100 - Management confirmed that results from the dose escalation part of Study 1100 will be presented at the SITC conference, with 28 patients injected and evaluable for safety [37] Question: Pathway for developing further indications - The company is currently focused on the head and neck franchise but sees potential for further development in collaboration with MD Anderson [40][41] Question: Timelines for NBTXR3 market entry - Management indicated that if interim readouts are positive, there may be a pathway for accelerated approval, with potential market entry around 2025 [46] Question: Study 1100 data benchmarks - Management provided benchmarks based on previous studies, indicating expected response rates for naive and refractory patients [52][54] Question: Registration pathway for immunotherapy combination trial - The company plans to submit a protocol to the FDA in Q1 2023, focusing on PD-1 resistant patient populations [58][61] Question: Collaboration with MD Anderson for pancreatic cancer - Management expects to receive data from the Phase 1 part of the pancreatic cancer trial by the end of the year, which will inform the next steps [64]
Nanobiotix(NBTX) - 2022 Q2 - Quarterly Report
2022-09-28 20:52
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ________________________ FORM 6-K ________________________ REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of report: September 28, 2022 Commission File Number: 001-39777 ________________________ NANOBIOTIX S.A. (Exact name of registrant as specified in its charter) _________________________ Nanobiotix S.A. 60 rue de Wattignies 75012 Paris, France (Address of principal ex ...
Nanobiotix(NBTX) - 2022 Q1 - Earnings Call Transcript
2022-05-19 18:43
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. ...
Nanobiotix(NBTX) - 2021 Q4 - Annual Report
2022-04-08 21:06
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].
Nanobiotix(NBTX) - 2021 Q4 - Earnings Call Transcript
2022-03-31 14:50
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]