Nanobiotix In License Deal With Johnson & Johnson Unit; Stock Climbs In Pre Market

(RTTNews) - Nanobiotix (NBTX), a French clinical-stage biotechnology company focused on cancer, announced Monday a global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV, affiliated to Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ). The deal is for the investigational, potential first-in-class radioenhancer NBTXR3.

In pre-market activity on Nasdaq, Nanobiotix shares were surging 54 percent to trade at $7.74.

Under the deal terms, in collaboration with the Interventional Oncology R&D Unit at Johnson & Johnson, Nanobiotix will grant Janssen a worldwide license for the development and commercialization of NBTXR3.

The license is exclusive, excepting territories previously licensed to Nanobiotix partner LianBio.

Nanobiotix will receive near term cash and operational support valued up to $60 million. This includes an upfront cash licensing fee of $30 million, and in-kind regulatory and development support for study NANORAY-312 valued at up to $30 million that Janssen may provide at its sole discretion.

The company will maintain operational control of NANORAY-312 and all other currently ongoing studies, along with NBTXR3 manufacture, clinical supply, and initial commercial supply.

In the deal, Janssen will be fully responsible for an initial Phase 2 study evaluating NBTXR3 for patients with stage three lung cancer and will have the right to assume control of studies currently led by Nanobiotix.

Nanobiotix is eligible for success-based payments of up to $1.8 billion, in the aggregate, relating to potential development, regulatory, and sales milestones.

Further, the agreement includes a framework for additional success-based potential development and regulatory milestone payments of up to $650 million, in the aggregate, for five new indications that may be developed by Janssen at its sole discretion. It also includes up to $220 million, in the aggregate, per indication that may be developed by Nanobiotix in alignment with Janssen.

NBTXR3 is currently being evaluated in several studies across solid tumor indications. These include NANORAY-312, a global Phase 3 pivotal study evaluating NBTXR3 for the treatment of patients with locally advanced head and neck cancer. NBTXR3 is also being evaluated for its potential as a systemic agent in combination with anti-PD-1 immune checkpoint inhibitors for patients with metastatic cancers.

Following commercialization, Nanobiotix will also receive tiered double-digit royalties on net sales of NBTXR3.

Separately, Nanobiotix is eligible to receive up to $30 million in equity investments from Johnson & Johnson Innovation - JJDC, Inc.

The transaction is subject to customary closing conditions and regulatory clearances including clearance by US antitrust authorities under the Hart-Scott-Rodino Act. It will become effective as soon as these conditions have been met.

As of the date the license agreement becomes effective, prior to utilizing the second tranche of equity investment outlined above and excluding near term development milestones, Nanobiotix expects to extend its cash runway into the first quarter of 2024.

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