On May 17, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported an update on operational progress and reported financial results for the for the first quarter of 2023 (Press release, Nanobiotix, MAY 17, 2023, View Source [SID1234631808]).
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"2023 will be a foundational year for Nanobiotix, and we are energized to further advance late-stage development of our radioenhancer NBTXR3 in head and neck cancer. The recent operational efficiencies implemented last year are working, and we are seeing enrollment progress well in our pivotal Phase 3 study, NANORAY-312, with 122 sites activated in 24 countries to date," said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. "We remain focused on our near-term milestones including final data for Study 102, and a first look at NBTXR3 in pancreatic cancer as part of our MD Anderson collaboration. We are excited to welcome a new Chief Medical Officer in the third quarter of this year who will help further enhance our clinical development strategy. We believe that the clinical and corporate framework we are establishing will strongly position us for growth and successful execution across our programs in the years ahead."
Pipeline Status and Expected Upcoming Milestones
Chief Medical Officer (CMO) candidate with strategically aligned experience in oncology and immuno-oncology is expected to join the organization in Q3 2023
Locally Advanced Head and Neck: Priority Registration Pathway in Locally Advanced Head & Neck Squamous Cell Carcinoma (LA-HNSCC), Local Control as Single Agent Activated by Radiotherapy (RT):
NANORAY-312 Phase 3 trial evaluating RT-activated NBTXR3 ± cetuximab vs RT ± cetuximab in elderly patients with LA-HNSCC
Futility analysis to be conducted following 25% of planned PFS events expected in H1 2024
Initial Phase 3 interim efficacy and safety data expected after 67% of planned PFS events in H2 2024
Study 102 Phase 1 trial evaluating RT-activated NBTXR3 in LA-HNSCC
Final safety and efficacy data expected in H2 2023
Recurrent/Metastatic Head and Neck: Priority Pathway in Immunotherapy for Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma (R/M HNSCC), Priming Immune Response Followed by an Anti-PD-1 Treatment:
Study 1100 Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 followed by an anti-PD-1 in patients with advanced cancers
Phase 1 data update anticipated at a time to be determined
Phase 3 registrational program for patients with unresectable locoregional recurrent (LRR) or recurrent or metastatic HNSCC resistant to previous anti-PD-1/PD-L1 therapy
Company plans to consult with incoming CMO prior to continuing discussions with FDA on potential registration pathway for an NBTXR3-immunotherapy approach, and expects to provide an update in Q3 2023
Pancreatic, Lung and others: Expanding NBTXR3 Opportunity, Collaborating with a World-Class Partner to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profile:
Ongoing collaboration with The University of Texas MD Anderson Cancer Center
Preliminary Phase 1b dose escalation safety data in PDAC expected in H2 2023
Completion of enrollment in Phase 1b dose expansion trial for PDAC expected in H2 2023
Determination of RP2D for NBTXR3 in non-small cell lung cancer (NSCLC) expected in H2 2023
Initial Phase 1b/2 data for NBTXR3 in combination with chemotherapy in patients with esophageal cancer expected in 2024
First Quarter Financial Updates
Cash and Cash Equivalents:
Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of €30.2 million as of March 31, 2023, will fund its operations into the third quarter of 2023, assuming no additional cash inflows, no business development transaction is consummated and assuming the European Investment Bank does in fact exercise the covenant requiring the Company to have a cash and cash equivalents balance at least equal to the principal of the loan balance currently at €25.3 million.
Next Annual General Meeting of the Company
The Company announced that its next Annual General Meeting ("AGM") will be held on June 27, 2023, at its headquarters, 60 rue de Wattignies, 75012 Paris, France. The notice of meeting of this AGM will be published shortly in the French legal bulletin and will include the agenda, the proposed resolutions as well as instructions to participate and vote in this AGM. All documentation regarding this AGM will be published on the Company’s website.