StemCell Therapy

PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News:

NANOBIOTIX (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 audited consolidated results for the fiscal year ending December 31, 2019:

2019 was a major year for Nanobiotix. We made significant progress in our clinical development plan and are proud to have received our first market approval in Europe for NBTXR3, under the brand name Hensify, in soft tissue sarcoma of the extremity and trunk wall. R&D expenses reflect the strength of our development plan and some key positions have been hired to sustain the activity. In 2020, we are prioritizing the registration pathway for head and neck cancer in the US and Europe, while also continuing our Immuno-Oncology program and evaluating NBTXR3 in other indications with our partners. Philippe Mauberna, Chief Financial Officer of Nanobiotix

The audited consolidated financial statements for the fiscal year ending December 31, 2019 have been approved by the Companys executive board and reviewed by the supervisory board on March 17, 2020.

Consolidated Income Statement: 1

In K

2019

2018

Total revenue and other income

2,541

3,479

Sales

68

116

Service

40

109

Other sales

28

7

Licenses

-

-

Other revenues

2,473

3,363

Research Tax Credit

2,437

3,251

Subsidies

20

90

Other

17

22

Research & Development (R&D) costs

(30,411)

(20,893)

Selling, General and Administrative (SG&A) costs

(18,909)

(12,653)

Operating loss

(46,779)

(30,067)

Financial loss

(4,133)

(277)

Income tax

(3)

-

Net loss for the period

(50,915)

(30,345)

Financial Review

Total Revenue in 2019 amounted to 2.5M vs. 3.5M in 2018, mainly due to:

Total Operating expenses reached 49.3M in 2019 vs. 33.5M in 2018:

Total consolidated headcount reached 110 as of December 31, 2019 vs. 102 as of December 31, 2018, in line with the Companys growth.

Net loss after tax amounted to 50.9M for the year ending December 31, 2019 (vs. 30.3M loss in 2018).

Cash available as of December 31, 2019 amounted to 35.1M (excluding the amount related to the 2018 research tax credit, which was received in February 2020)

Nanobiotix activities and achievements in 2019

Clinical

First ever radioenhancer to receive European market approval

In April 2019, the Company announced that Hensify received European market approval enabling commercialization in 27 European Union countries for the treatment of locally advanced soft tissue sarcoma (STS). Hensify is the brand name for NBTXR3 as approved for the treatment of locally advanced STS.

In July 2019, results from the randomized Phase II/III trial evaluating NBTXR3 in patients with locally advanced STS were published in The Lancet Oncology. The data from the registration study (Act.In.Sarc) demonstrated a significant advantage in both pathological complete response (pCR) and rate of margin-negative resection (R0) for those treated with NBTXR3 activated by radiation therapy (RT) versus RT alone. Data showed that an increase in efficacy was achieved with the addition of NBTXR3, without a significant difference in the safety profile compared to RT alone.

NBTXR3 may present as a valuable option for patients with hepatocellular carcinoma or liver metastasis

During an oral presentation at the ASTRO 2019 annual meeting, Nanobiotix announced phase I results in liver cancer. The study showed promising signs of efficacy for hepatocellular carcinoma (HCC) patients, as every evaluable patient responded and over half (62.5%) reached complete response. Moreover, given that the safety profile was very good, a 5th dose escalation level has been added to the trial.

Clinical collaboration(s)

MD Anderson

In January 2019, the Company announced a clinical collaboration with MD Anderson. This agreement expanded the clinical development plan for NBTXR3, as the nine MD Anderson-led trials will evaluate the product in new indications and patient populations, and should involve around 340 patients.

Pre-clinical collaboration(s)

MD Anderson and Weill Cornell Medical College

At AACR 2019, Nanobiotix presented pre-clinical data from studies currently being conducted through its collaborations with MD Anderson and the Weill Cornell Medical College, demonstrating the efficacy of treatment combinations including NBTXR3, radiotherapy, and anti-PD-1 immunotherapy in treating resistant pre-clinical in vivo lung cancer models.

In November during SITC 2019, Nanobiotix announced new results from an in vivo pre-clinical study showing the generation of adaptive immune response (turning cold tumors into hot tumors), better local control, increased abscopal effect, and significantly increased survival for NBTXR3 activated by RT and anti-PD-1 in combination versus RT alone in combination with anti-PD-1. Additionally, an in vivo RadScopal model showed superior local control along with significant increases in abscopal effect and survival for treatments combining NBTXR3 activated by RT with anti-PD-1 and anti-CTLA-4 versus all other tested combinations.

Financial Events

Registered public offering in the United States

Nanobiotix announced that it planned to conduct a registered public offering of ordinary shares, including in the form of American Depositary Shares (ADSs) in the United States, and has confidentially submitted a draft registration statement on Form F-1 to the U.S. Securities and Exchange Commission.2

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NANOBIOTIX 2019 Annual Results - Business Wire

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