NANOBIOTIX half year results for the six months ended June 30, 2018

Nanobiotix half year results for the six months ended June 30, 2018

• 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."

Financial highlights

• 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)

Financial events

• Nanobiotix entered Euronext's Tech40 label, recognizing the best performing Tech SMEs listed on Euronext markets.

Operational highlights

• 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 development of NBTXR3 clinical trial in the head and neck cancers indication and to support the European go-to-market strategy.

             
Financial Review (IFRS)

Total revenue for H1 2018 amounted to €2.1m (H1 2017: €1.9m), made of:

• The recharge of costs related to activities planned from partnerships with PharmaEngine, slightly higher than prior year (€0.1m vs. €0.1m in H1 2017)
• Other revenues amounted to €2.0m mainly made of subsidies (€0.2m) and the Research Tax Credit (CIR) for €1.8m, stable compared to prior year

Operating expenses for the 6 months to June 30, 2018 were €15.0m (H1 2017: €13.7m), broken down as follows:

• Operating costs, excluding share-based payments, amounted to €13.9m (H1 2017: €11.8m)
• R&D expenses amounted to €8.6m (H1 2017: €7.2m), in line with the current level of activity of on-going clinical programs as well as the strengthening of the teams, whereas selling, general and administrative (SG&A) costs were €5.3m (H1 2017: €4.5m). This increase was also primarily due to the strengthening of teams, particularly in view of the next steps in market access, while external costs were stable.
• Shares based payment amounted to €1.1m (-€0.8m compared to H1 2017)

The Group reports an operating loss of €13.0m for the half year 2018 (H1 2017: €11.8m loss).

The total comprehensive loss for the period was €12.6m (H1 2017: €12.2m).

At June 30, 2018, the cash balance was €32.7m (December 31, 2017: €47.2m).

Total Group headcount continues to increase in order to support the Group's strategy and reached 95 employees on June 30, 2018 (compared to 85 at December 31, 2017).

Breakdown of Nanobiotix's shareholding structure as of June 30, 2018

The half year financial report has been subject to a limited review by Nanobiotix' statutory auditors. The consolidated financial statements at June 30, 2018 were established in accordance with IAS 34 norm. Such documents are available on the Company's website at www.nanobiotix.com.

***

Next financial press release: revenue for the third quarter of 2018 on 15 November 2018.

***

About NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a leading, late 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 one rooted in designing pioneer physical based approaches to bring highly effective and generalized solutions to address high unmet medical needs and challenges.  

The Company's first-in-class, proprietary lead technology, NanoXray, aims to expand radiotherapy benefits for millions of cancer patients. Furthermore, the Company'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 based in Paris, France, with a U.S. affiliate in Cambridge, MA, and european affiliates in Spain and Germany.

Contact

Disclaimer
This press release contains certain forward-looking statements concerning Nanobiotix and its business. 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 filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.17-0470 on April 28, 2017 as well as in its 2017 annual financial report filed with the French Financial Markets Authority on March 29, 2018 (a copy of which is available on www.nanobiotix.com) 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. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country. At the moment NBTXR3 does not bear a CE mark and is not permitted to be placed on the market or put into service until NBTXR3 has obtained a CE mark.