On July 17, 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 revenue for the second quarter of 2020 as well as for the first half of 2020 (Press release, Nanobiotix, JUL 17, 2020, View Source [SID1234562074]).
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Revenue for the second quarter of 2020 (unaudited)
Nanobiotix’s revenue for the second quarter 2020 and for the first half of 2020 amounted to €13.4k and €36.9k respectively.
Most of the revenue generated by the Company during these periods result from the cross-charge to its partner, PharmaEngine, of shared external contract research organization costs pursuant to the license and collaboration agreement.
The amount of cash and cash equivalent as of June 30, 2020 is €26.6m. This amount reflects in particular the payment by HSBC of a €5m State-Guaranteed Loan (prêt garanti par l’Etat or PGE) granted pursuant to an agreement approved on June 22, 2020. The second PGE of €5m granted by Bpifrance has been received on July 17, 2020.
In April 2020, the Company provided updates on clinical development continuity in the context of the COVID-19 crisis. In light of the pandemic and to protect the interests of employees, patients, partners, and shareholders, Nanobiotix made organizational adjustments to control costs while priorities regarding clinical development remained unchanged.
Nanobiotix also announced that the protocol for the phase I clinical trial for NBTXR3 in pancreatic cancer under its clinical collaboration with The University of Texas MD Anderson Cancer Center has been allowed to proceed by the US Food and Drug Administration (FDA).
At ASCO (Free ASCO Whitepaper) 2020, Nanobiotix announced positive new data from the expansion part of its phase I trial, evaluating the potential of first-in-class NBTXR3 activated by radiation therapy to improve treatment outcomes for elderly patients with locally advanced head and neck cancer ineligible for chemotherapy or intolerant to cetuximab. In particular, the analysis of 30 evaluable patients for efficacy showed a primary tumor objective response rate of 83%, including a complete response rate of 60% in the target lesion.
At AACR (Free AACR Whitepaper) 2020, Curadigm, a wholly owned subsidiary of the Company, presented results demonstrating that its novel "Nanoprimer" technology could potentially improve the efficacy of therapeutics delivered intravenously (IV). In the study, the Nanoprimer was paired with RNA-based therapeutics and showed to improve treatment outcomes up to 50%.
On June 17, 2020, the US Food and Drug Administration (FDA) provided feedback necessary to proceed with the design of NANORAY-312, a pivotal phase III trial investigating NBTXR3 for elderly head and neck cancer patients ineligible for platinum-based chemotherapy. The FDA also accepted the NBTXR3 chemistry, manufacturing and controls (CMC) development plan to support the future New Drug Application (NDA) for the product and its use in the NANORAY-312 phase III clinical trial.