Full Press Release Details
NANOBIOTIX PROVIDES SECOND QUARTER OPERATIONAL AND FINANCIAL UPDATE
Paris, France; Cambridge, Massachusetts (USA); July 20, 2021
- 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, today announced operational progress and cash position (unaudited) for the second quarter of 2021.
Second Quarter Financial Updates
Nanobiotix reported total revenue for the six-month period ended June 30, 2021 of 9.7k. Revenue for the first half of 2021 was primarily driven by cross
charges related to the Company's previous collaboration with PharmaEngine, Inc., during the first quarter 2021. Nanobiotix did not generate any revenue during the second quarter of 2021. Revenue for the second quarter and first half of 2020
amounted to 13.4k and 36.9k respectively.
Nanobiotix reported cash, cash equivalents, and short-term investments totaling 102.3 million as of June 30, 2021, compared to 107.1 million as of March 31, 2021. This amount includes the 16.5 million ($20.0 million) upfront payment associated with the LianBio collaboration announced in May 2021. As previously announced, PharmaEngine was eligible for and received a 2.1 million ($2.5 million) payment following the announcement of Nanobiotix's collaboration with
LianBio and has received 3.4 million ($4.0 million) in conjunction with the completion
of various administrative steps in connection with the winding-up of the collaboration. PharmaEngine will be eligible to receive an additional $1.0 million in administrative fees and a final payment of $5 million upon a second regulatory approval
of an NBTXR3-containing product.
Nanobiotix plans to report half-year financial results for the six-months ended June 30, 2021, including condensed consolidated financial statements for the
period, on September 8, 2021.
Second Quarter Operational Highlights
Updated Financial Agenda
September 8: Half-Year Corporate and Financial Update
October 20th: Third Quarter Corporate and Financial Update
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time
intratumoral injection and activated by radiotherapy. The product candidate's physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering
adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly
immune checkpoint inhibitors.
NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I
dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch in 2021. In February 2020, the United States Food and Drug Administration
granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy-the
same population being evaluated in the planned phase III study.
Nanobiotix has also prioritized an Immuno-Oncology development program-beginning with a Company-sponsored phase I clinical study evaluating NBTXR3 activated
by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.
Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with
world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The
University of Texas MD Anderson Cancer Center (MD Anderson) for MD Anderson to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.
Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for
millions of patients; supported by people committed to making a difference for humanity. The company's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.
Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France,
Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.
Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2)
bioavailability and biodistribution; and 3) disorders of the central nervous system. The company's resources are primarily devoted to the development of its lead product candidate-NBTXR3-which is the product of its proprietary oncology platform and
has already achieved market authorization in Europe for the treatment of patients with soft tissue sarcoma under the brand name Hensify .
This press release contains certain
"forward-looking" statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "at this time," "anticipate," "believe,"
"expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information
currently available to management, include statements about the timing and progress of clinical trials, the timing of our presentation of data, the results of our preclinical and clinical studies and their potential implications, the development and commercialization of NBTXR3, and the execution of the
Company's development and commercialization strategy. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking
statements are subject to numerous risks and uncertainties, including with respect to the risk that subsequent studies and ongoing or future clinical trials may not generate favorable data notwithstanding positive preclinical or early clinical
result and the risks associated with the evolving nature of the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to it. Furthermore, many other important factors, including those
described in Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French
Financial Markets Authority (Autorit des march s financiers) under number D.21-0272 on April 7, 2021 (a copy of which is available on www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such
forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
| Nanobiotix | ||
| Nanobiotix Communications Brandon Owens VP, Communications +1 (617) 852-4835 contact@nanobiotix.com | Nanobiotix Investor Relations Kate McNeil SVP, Investor Relations +1 (609) 678-7388 investors@nanobiotix.com | |
| Media Relations | ||
| France - Ulysse Communication Pierre-Louis Germain + 33 (0) 6 64 79 97 51 plgermain@ulysse-communication.com | US - Porter Novelli Dan Childs +1 (781) 888 5106 dan.childs@porternovelli.com |