Major milestones achieved with the success of Soft Tissue Sarcoma phase III clinical trial with first-in-class NBTXR3 product
Overall expenses according to plan
Post cloture event: financial partnership with European Investment Bank (EIB) allowing visibility beyond 2019
Paris, France and Cambridge, Massachusetts, USA, September 4, 2018 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announces its half year results for the six months ended June 30 2018, from the consolidated financial statements at June 30, 2018 that have been reviewed by the supervisory board dated September 4, 2018.
Philippe Mauberna, CFO of Nanobiotix, commented: “For the first half of 2018, the group pursued its growth in line with operational development expectations. The period has been marked by the positive topline results on the phase II/III soft tissue sarcoma clinical study and by the formation of new immuno-oncology partnerships with high level research institutes in the USA. The cash position at the end of June, strengthened by the partnership with the European Investment Bank after reporting period, enables us to secure our growth beyond 2019.”
Operating revenues for the first half of 2018 were €2.1m (H1 2017: €1.9m), including €1.8 m of Research Tax Credits (CIR)
As expected, operating expenses were higher compared to last year (€15.0m in H1 2018 vs. €13.7m in H1 2017)
The operating result for the period was a €13.0m loss compared to a €11.8m loss in H1 2017
The Group had cash and cash equivalents at June 30, 2018 of €32.7 m (31 December 2017: €47.2m)
Nanobiotix entered Euronext’s Tech40 label, recognizing the best performing Tech SMEs listed on Euronext markets.
Nanobiotix announced positive phase II/III topline data in Soft Tissue Sarcoma with NBTXR3. The trial achieved its primary endpoint of pathological Complete Response Rate and its secondary endpoint in operability (R0 rate). NBTXR3 demonstrated significant superiority and clinical benefits for patients compared to the standard of care. The safety profile was confirmed. This randomized trial validated the first-in-class mode of action of NBTXR3.
Nanobiotix presented first promising data from I/II trial evaluating NBTXR3 in liver cancers, including primary (Hepatocellular, HCC) and liver metastasis from other tumors, at the American Society of Clinical Oncology Gastrointestinal Annual Meeting (ASCO-GI).
Nanobiotix presented preclinical data showing that NBTXR3 nanoparticles can activate the cGAS-STING pathway at the American Association for Cancer Research (AACR) Annual Meeting 2018 in Chicago, Illinois, USA. These observations support the rationale for using NBTXR3 with radiation therapy in combination with immunotherapeutic agents and/or STING agonist to transform tumors into an in-situ cancer vaccine.
Nanobiotix partnered with the Providence Cancer Institute to run immunotherapeutic preclinical research in pancreatic cancers. The collaboration with Providence Cancer Institute will enable to provide essential preclinical data on the ability of NBTXR3 activated by radiotherapy to induce an antitumoral immune response.
Nanobiotix also announced that it will cooperate with The University of Texas MD Anderson Cancer Center, Houston TX, USA, to run immunotherapeutic pre-clinical research in lung cancer, combining NBTXR3 and Nivolumab. This project with MD Anderson, one of the world’s leading oncological research centers, will enable to provide an unparalleled ability to develop pre-clinical data using NBTXR3 activated by radiotherapy plus anti-PD1 Nivolumab (murine version of Opdivo(TM)).
Nanobiotix announced that it is launching a research collaboration with Weill Cornell Medicine to begin nonclinical studies to evaluate the impact of NBTXR3 on cGAS-STING pathway in mammary cancers. The research collaboration will be conducted over the course of one year, with the goal of continuing the exploration of the role of NBTXR3 in immuno-oncology.
Post period end main highlights
The Company launched in July 2018, a non-dilutive financial partnership with the European Investment Bank (EIB) to boost its research, development and innovation activities. The financing agreement will allow the Company to borrow up to €40m through loan over the coming five years subject to achieving a set of agreed performance criteria. This financing agreement will enable Nanobiotix to accelerate both the developent of NBTXR3 clinical trial in the head and neck cancers indication and to support the European go-to-market strategy.