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Nanobiotix filed its universal registration document and Annual Report on Form 20-F for the financial year ended December 31, 2021, with the AMF and SEC, respectively. These documents include the annual financial report, corporate governance management report, auditor's reports, and details about the company’s share buyback program. Notably, Nanobiotix's NBTXR3, a novel oncology product, is showing early efficacy signs in clinical trials for advanced head and neck cancer. The company plans future financial updates on May 10, June 21, September 7, and November 9, 2022.
LianBio announced that its partner, ReViral Ltd., is set to be acquired by Pfizer. This acquisition enhances LianBio's existing partnership with Pfizer, focused on developing sisunatovir, an antiviral for respiratory syncytial virus (RSV). The strategic collaboration aims to bring innovative therapeutics to Greater China. CEO Yizhe Wang expressed optimism regarding the acquisition's potential to expand their mission. This follows LianBio's previous agreements with Pfizer and ReViral, enhancing their capacity to deliver transformative medicines in Asia.
LianBio (Nasdaq: LIAN) has appointed Wei Wei Chen to its Board of Directors, announced on April 7, 2022. Chen brings over 17 years of financial experience, having served as CFO for various companies including Starbucks (China) and Yum! Brands. Her appointment is expected to enhance LianBio's growth strategy and development of its diverse medicine pipeline aimed at patients in China and Asia. CEO Yizhe Wang emphasized her expertise in the Chinese market and transformation initiatives as crucial for the company’s advancement.
LianBio (Nasdaq: LIAN) announced a Phase 3 trial of mavacamten for obstructive hypertrophic cardiomyopathy (oHCM) in Chinese patients, having received Breakthrough Therapy Designation in China. The drug infigratinib was approved for cholangiocarcinoma in Hainan Province under a special program. The company reported a net loss of $21.2 million in Q4 2021, an increase from the previous year. Despite rising expenses, LianBio's cash balance stands at $403.2 million, providing a financial runway into 2023.
Nanobiotix provided an operational and financial update, highlighting significant clinical advancements for its lead candidate, NBTXR3. In the Expansion Study 102 involving high-risk, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients, the median overall survival reached 23 months. The company reported €83.9 million in cash as of December 31, 2021, down from €119.2 million in 2020. Revenue for 2021 was only €9.7k compared to €50.0k in 2020. Despite a net loss of €47.0 million, Nanobiotix is advancing multiple pivotal studies in 2022.
Nanobiotix (NASDAQ: NBTX, Euronext: NANO) will report its full-year financial results for December 31, 2021, on March 30, 2022, after market close. The announcement will precede a conference call on March 31, 2022, at 8:00 AM EDT, led by CEO Laurent Levy and CFO Bart Van Rhijn. Investors can submit questions ahead of time via email. The company is advancing its lead oncology product, NBTXR3, currently in clinical trials for head and neck cancer, with strategic collaborations for further development in various cancer types and therapies.
LianBio (Nasdaq: LIAN) announced on March 8, 2022, that it is not identified as a 'Commission-Identified Issuer' under the Holding Foreign Companies Accountable Act (HFCAA) by the U.S. Securities and Exchange Commission (SEC).
Due to its principal auditor being a PCAOB-inspected firm in New York, LianBio expects to remain compliant and not subject to HFCAA provisions affecting companies with foreign auditors.
LianBio (Nasdaq: LIAN) announced that the Center for Drug Evaluation (CDE) in China has granted Breakthrough Therapy Designation for mavacamten, targeting obstructive hypertrophic cardiomyopathy (oHCM). This designation allows expedited development based on the successful global Phase 3 EXPLORER-HCM trial, where mavacamten met all primary and secondary endpoints, showing significant functional improvement for patients. The ongoing EXPLORER-CN trial in China will further assess mavacamten's safety and efficacy, enrolling approximately 81 patients, to enhance treatment options for the estimated 1.1 to 2.8 million HCM patients in China.
Nanobiotix has announced a peer-reviewed clinical case study published in Clinical and Translational Radiation Oncology regarding its first-in-human treatment of NBTXR3 for unresectable pancreatic cancer. The study shows the feasibility of local endoscopic delivery with no treatment-related toxicity. Supported by MD Anderson Cancer Center, this phase I trial aims to assess the safety and establish a recommended phase II dose for future efficacy evaluation. The treatment may address unmet needs in managing locally advanced pancreatic cancer.
Nanobiotix announced the publication of new preclinical data for NBTXR3, which shows significant anti-tumor effects in an anti-PD-1 resistant lung cancer model. The study revealed that adding NBTXR3 to a combination of radiotherapy, anti-PD-1, and anti-CTLA-4 improved mouse survival rates from 0% to 50%. Notably, no re-challenged mice developed tumors, indicating a long-term anti-tumor immune memory. The data suggests the potential for further investigations of NBTXR3's immune priming effects in both preclinical and clinical settings.