On April 30, 2020 NANOBIOTIX (Paris:NANO) (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenues for the first quarter of 2020 (Press release, Nanobiotix, APR 30, 2020, View Source [SID1234556864]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Nanobiotix’ revenue for the first quarter 2020 amounted to €24k.
Most of the revenues generated by the Company during this period result from the crossed charged to our partner, PharmaEngine, of shared external contract research organization costs pursuant to our license and collaboration agreement.
The amount of cash and cash equivalent as of March 31st, 2020 amounted to €28m.
In January 2020, the Company announced its Head and Neck phase III registration trial (Study 312) and global development strategy for 2020.
Study 312 is a phase III, dual-arm, randomized (1:1) global registration trial including elderly head and neck cancer patients who are ineligible for platinum-based chemotherapy. The design of study 312 is currently under review by the U.S. Food and Drug Administration (FDA). In February 2020, NBTXR3 received Fast Track designation by the US FDA in that indication. Fast Track is a process designed to facilitate the development and accelerate the review of drugs for serious conditions and that have the potential to address unmet medical needs. The purpose is to expedite the availability of new treatment options for patients.
Once approved, the trial will launch as soon as the requisite financing is secured. The trial should recruit around 500 patients with the initial readout based on event-driven progression-free survival (PFS), and the final readout on PFS and overall survival (OS). A futility analysis is expected 18 months after the first patient is randomized, the interim analysis for PFS superiority is expected at 24-30 months, and final analysis will report on PFS and OS.
The Company also announced in January 2020 that it is moving forward with its evaluation of NBTXR3 as a potential pillar of immuno-oncology, given positive data showing that the product may generate an immune response in patients on its own, and also increase the efficacy of immune checkpoint inhibitors in combination. Although recruitment has been impacted by the global pandemic, the Company remains on track to report first new data on patients already recruited within the next few months.
In parallel, Nanobiotix collaborators will continue to develop NBTXR3 across several additional indications including lung, esophageal, pancreatic, and others.
Finally, the Company provided in April 2020 updates on clinical development continuity in the context of the Covid-19 crisis1. As the Company primary concern is to protect the interests of its employees and its patients, as well as its partners, and shareholders, Nanobiotix has made organizational adjustments to control costs. The Company is also in active discussions regarding non-dilutive financing options both public and private.