PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Regulatory News:
(Paris:NANO) (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced its unaudited revenues for the first quarter of 2020.
In K€ (unaudited) |
Q1 2020 |
Q1 2019 |
||
Revenues |
24 |
5 |
||
|
|
|
||
Of which licenses |
- |
- |
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Of which services |
24 |
5 |
Activity and results
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.
Next financial press release: revenue for Q2 2020 on July 17, 2020
About NANOBIOTIX:
Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.
The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.
Nanobiotix’s first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotix’s Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.
Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP). The Company’s headquarters are in Paris, France with a U.S. affiliate in Cambridge, MA, and European affiliates in Spain and Germany. The Company also possesses an affiliate, Curadigm, located in Paris, France and Cambridge, MA in the U.S.
Disclaimer
This press release contains certain forward-looking statements concerning Nanobiotix and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.19-018 on April 30, 2019 (a copy of which is available on ) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements.
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