Paris, France; Cambridge, Massachusetts (USA); February 26, 2021 – NANOBIOTIX (Euronext : NANO – – NASDAQ: NBTX – the ‘‘Company’’), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, announced its revenues for the fourth quarter and full year ended December 31, 2020.
Full Year 2020 Revenue
|Twelve Months Ended December 31st|
|Of which licenses||–||–|
|Of which services||50||68|
Fourth Quarter 2020 Revenue
|Q4 2020||Q3 2020||Q2 2020||Q1 2020|
|Of which licenses||–||–||–||–|
|Of which services||-1.5||14.7||13.4||23.5|
Full Year and Fourth Quarter 2020 Financial Results
Nanobiotix generated annual revenue of approximately €50K, driven primarily by the charging-back of costs incurred on behalf of PharmaEngine in connection with the Company’s license and collaboration agreement with PharmaEngine. The absence of revenues in the fourth quarter of 2020 is explained by the issuance of a credit note following an annual adjustment.
The Company’s cash and cash equivalents as of December 31st, 2020 amounted to €119.2M following completion of a successful U.S. initial public offering on the Nasdaq Global Select Market in December 2020 resulting in total gross proceeds of €93.5 million ($113.3 million based on an exchange rate of €1.00=$1.2115). Net proceeds, after deducting underwriting commissions and other offering expenses, were €82.8 million (€100.4 million). Nanobiotix anticipates that its current cash position will be sufficient to fund current operations and planned development activity through the middle of the second quarter of 2023.
Key Events in Fourth Quarter 2020 and After the Reporting Period
In October 2020, Nanobiotix announced that the first patient had been injected with NBTXR3 in the Company’s phase I trial evaluating NBTXR3 activated by radiation therapy for patients with pancreatic cancer, and that “safe to proceed” notifications had been received from the U.S. Food and Drug Administration (FDA) for two additional trials: (i) a phase I study evaluating NBTXR3 activated by radiation therapy for patients with lung cancer amenable to re-irradiation (Study 2020-0123) and (ii) a phase I study evaluating NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer (Study 2020-0122). These studies are being conducted as part of an ongoing clinical collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson).
In November 2020, the Company presented positive first clinical data at the 35th Anniversary Annual Meeting of The Society for Immunotherapy of Cancer (SITC) suggesting that NBTXR3 activated by radiation therapy in combination with pembrolizumab or nivolumab (anti-PD-1 checkpoint inhibitors) could transformanti-PD-1 non-responders into responders.
At SITC, Nanobiotix also published a pre-clinical study revealing that NBTXR3 activated by radiotherapy could under certain circumstances produce a strong abscopal effect without checkpoint inhibitor combination, stimulate adaptive antitumor immunity and increase TCR repertoire diversity in treated tumors compared to radiation therapy alone.
A second pre-clinical study presented at SITC showed that NBTXR3 plus high dose and low dose radiation (RadScopalTM) combined with anti-PD-1 and anti-CTLA-4 could significantly improve control of both the primary and secondary tumors, extend survival, and reduce lung metastases in an anti-PD-1 resistant lung cancer in vivo model—and the treatment combination was observed to promote an anti-tumor response at both molecular and cellular levels and to produce long-term anti-tumor memory.
Also in November 2020, Nanobiotix announced that the FDA had provided “safe to proceed” notifications for two additional phase II clinical studies with MD Anderson. The first clinical study (Study 2020-0541) targets patients with recurrent or metastatic head and neck squamous cell carcinoma with limited PD-L1 expression, or that are refractory to PD-1 blockade. The second clinical study (Study 2020-0354) targets patients with inoperable locoregional recurrent head and neck squamous cell carcinoma amenable to re-irradiation.
In December 2020, Nanobiotix successfully completed its U.S. initial public offering on the Nasdaq Global Select Market, the operation also included the launch of a placement in Euronext market.
In January 2021, Nanobiotix announced that the first patient has been injected in a phase I study evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer (Study 2020-0122).
Also in January 2021, Nanobiotix announced that its wholly-owned subsidiary Curadigm was selected for a new collaboration agreement with Sanofi. Pursuant to Sanofi’s selection of a project involving Curadigm’s Nanoprimer technology as a promising option to significantly improve gene therapy development, Curadigm entered into a one-year agreement with Sanofi inclusive of direct funding and scientific exchanges. The goal of the project is to establish proof-of-concept for the Nanoprimer as a combination product that could improve treatment outcomes for gene therapy candidates.
2021 Financial Agenda
Nanobiotix plans to announce its financial and operating results as follows:
 Annual revenue regularization resulting in the issuance of a credit note in Q4 2020.