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ReViral Ltd. announces the appointment of Dr. Brett Haumann as Chief Medical Officer, responsible for global clinical development and regulatory strategy. Dr. Haumann has a proven track record in respiratory and infectious diseases, including leadership roles at Theravance Biopharma and GlaxoSmithKline. His expertise will support the development of ReViral's lead candidate, sisunatovir, currently in phase 2 studies for RSV infections in infants. ReViral is focused on antiviral therapeutics and aims to address the substantial global disease burden posed by RSV.
LianBio announced the initiation of the Phase 3 EXPLORER-CN clinical trial for mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), marking a significant milestone for the company. The trial aims to enroll approximately 81 patients to support a New Drug Application in China. Mavacamten has shown promising results in global trials, demonstrating significant improvements in patient outcomes. This drug represents a potential first-in-class treatment for patients in China, where oHCM affects over 1 million individuals.
Nanobiotix has provided a corporate update, highlighting significant advancements with NBTXR3 for treating head and neck cancer. The first European patient has been randomized in the pivotal NANORAY-312 study, with U.S. and Asia site activations expected to follow. The company aims to establish a registration pathway for NBTXR3 in combination with anti-PD-1 therapy based on positive initial data from ongoing studies. Financially, Nanobiotix has extended its operating runway into Q2 2023 through improved operational efficiencies and capital optimization.
Nanobiotix announced the first patient enrollment in the pivotal NANORAY-312 phase III study assessing radiotherapy-activated NBTXR3, with or without cetuximab, for elderly patients with locally advanced head and neck squamous cell carcinoma. This study aims to prove the superiority of NBTXR3 over standard treatments. The US FDA has granted Fast Track designation for NBTXR3 in this patient group, allowing for faster review and potential accelerated approval.
LianBio (Nasdaq: LIAN) announced the approval of infigratinib for treating unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 alterations in Hainan Province, China, under the Named Patient Program. This marks the first prescription of infigratinib outside North America, highlighting LianBio's commitment to enhancing access to innovative treatments. Infigratinib is a selective FGFR inhibitor and is currently in trials for various cancers. Approximately 72,000 cholangiocarcinoma cases are diagnosed annually in China, with a five-year survival rate of only 9%.
LianBio (Nasdaq: LIAN) announced significant achievements, including completing dosing in a pharmacokinetic (PK) study of mavacamten and initiating a Phase 2a trial of infigratinib for advanced gastric cancer. The company strengthened its leadership team and completed an IPO, raising $334.5 million, ensuring cash runway through 2023. R&D expenses for Q3 2021 were $4.7 million, down from $116.9 million in the same period last year. LianBio reported a net loss of $13.1 million for Q3 2021, a significant reduction from $120.2 million in Q3 2020.
Citibank has been appointed as the depositary bank for LianBio's American Depositary Receipt (ADR) program, coinciding with an IPO of approximately $325 million. Each ADS is priced at $16.00 and represents one ordinary share, listed on Nasdaq under the ticker symbol LIAN. Dirk Jones, Global Head of Issuer Services at Citi, emphasized Citi's commitment to providing high-quality ADR services for LianBio, showcasing Citi's extensive cross-border capabilities. This collaboration aims to enhance capital market access for global investors.
LianBio has announced the pricing of its initial public offering (IPO) of 20,312,500 American depositary shares (ADSs) at $16.00 per ADS, totaling approximately $325 million in gross proceeds. All ADSs are being offered by LianBio, which has also granted underwriters a 30-day option to purchase an additional 3,046,875 ADSs. The ADSs will begin trading on Nasdaq under the symbol 'LIAN' on November 1, 2021, with the offering expected to close on November 3, 2021. The registration statement for this offering became effective on October 29, 2021.