PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Regulatory Information:
NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Firm’’) (Paris:NANO) (NASDAQ:NBTX), a late-clinical stage biotechnology firm pioneering physics-based approaches to increase therapy prospects for sufferers with most cancers, at present introduced operational progress and money place (unaudited) for the second quarter of 2021.
Second Quarter Monetary Updates
Nanobiotix reported whole income for the six-month interval ended June 30, 2021 of €9.7k. Income for the primary half of 2021 was primarily pushed by cross fees associated to the Firm’s earlier collaboration with PharmaEngine, Inc., throughout the first quarter 2021. Nanobiotix didn’t generate any income throughout the second quarter of 2021. Income for the second quarter and first half of 2020 amounted to €13.4k and €36.9k respectively.
Nanobiotix reported money, money equivalents, and short-term investments totaling €102.3 million as of June 30, 2021, in comparison with €107.1 million as of March 31, 2021. This quantity consists of the €16.5 million ($20.0 million) upfront cost related to the LianBio collaboration introduced in Could 2021. As beforehand introduced, PharmaEngine was eligible for and acquired a €2.1 million ($2.5 million) cost following the announcement of Nanobiotix’s collaboration with LianBio and has acquired €3.4 million ($4.0 million) along side the completion of assorted administrative steps in reference to the winding-up of the collaboration. PharmaEngine will probably be eligible to obtain a further $1.0 million in administrative charges and a closing cost of $5 million upon a second regulatory approval of an NBTXR3-containing product.
Nanobiotix plans to report half-year monetary outcomes for the six-months ended June 30, 2021, together with condensed consolidated monetary statements for the interval, on September 8, 2021.
Second Quarter Operational Highlights
Introduced Up to date Outcomes from Precedence Pathways in Head and Neck Most cancers and Immunotherapy for Potential First-In-Class Radioenhancer NBTXR3 at 2021 Annual Assembly of The American Society for Scientific Oncology (ASCO):
- Native Management as a Single-Agent for Sufferers with Head and Neck Most cancers: Up to date knowledge from Examine 102, a part I research evaluating NBTXR3 as a single agent activated by radiotherapy in domestically superior head and neck squamous cell carcinoma (LA- HNSCC) offered at ASCO additional assist NBTXR3 administration as possible, and well-tolerated with a positive security profile in extremely susceptible aged LA-HNSCC sufferers with excessive unmet medical wants and important burden of illness. At a median observe up of 8.1 months, evaluable sufferers (n=40) demonstrated a excessive main tumor ORR of 82.5% and a 62.5% CRR. These outcomes are in step with these noticed within the dose escalation a part of the research and recommend sturdiness of efficacy. Nanobiotix plans to launch a pivotal part III world registration research evaluating NBTXR3 as a single-agent activated by radiotherapy for sufferers with LA-HNSCC within the second half of 2021.
- Priming Immune Response and Immunotherapy Mixture Throughout Oncology:Up to date knowledge from Examine 1100, a part I basket research evaluating NBTXR3 activated by radiotherapy (RT) together with nivolumab or pembrolizumab in locoregional recurrent or recurrent metastatic HNSCC, lung metastasis from any main tumor and/or liver metastasis from any main tumor confirmed tumor regression in 76.9% of evaluable sufferers (n=13) no matter prior anti-PD-1 publicity. Knowledge from this ongoing research present NBTXR3 plus radiotherapy may doubtlessly stimulate immune response and convert anti-PD-1 non-responders into responders.
Shaped Strategic Partnership with LianBio to Develop and Commercialize NBTXR3 Throughout Tumor Sorts and Therapeutic Combos in China and different Asian markets:
- LianBio’s cross-border growth and commercialization experience consists of sturdy capabilities in oncology: LianBio will take part within the Nanobiotix world part III HNSCC registrational research by enrolling 100 sufferers in China. Along with the part III head and neck most cancers research, LianBio has dedicated to enrolling sufferers in 4 extra registrational research carried out by Nanobiotix throughout indications and therapeutic mixtures. Beneath the phrases of the settlement, LianBio will receive unique rights to develop and commercialize NBTXR3 in Larger China, South Korea, Singapore, and Thailand. Nanobiotix acquired a $20 million upfront cost and is entitled to obtain as much as an mixture of $220 million in potential contingent, growth and commercialization milestone funds together with tiered, low double-digit royalties based mostly on internet gross sales of NBTXR3 within the licensed territories.
Strengthened Board & Management Workforce to Focus Efforts on Advancing Its International Improvement Technique:
- Named Gary Phillips, MD, as the brand new chairman of the Firm’s supervisory board: Dr. Phillips, who’s the president and chief government officer of OrphoMed, Inc., brings a long time of expertise within the pharmaceutical and healthcare industries the place he has led industrial operations, scientific medication, enterprise technique, and growth capabilities.
- Appointed Bart Van Rhijn, MBA, as chief monetary officer and member of the Firm’s government board: Mr. Van Rhijn brings in depth expertise in consultancy, know-how, and life sciences industries and joins Nanobiotix after practically 3 years as chief monetary officer at Servier Prescription drugs, LLC (Servier US). Previous to Servier US, he held management roles in distinguished organizations in Europe and North America, together with PricewaterhouseCoopers, Philips and Galderma, together with Head of Tax, Senior Director of Mergers and Acquisitions, and Head of Finance positions.
Up to date Monetary Agenda
September 8: Half-12 months Company and Monetary Replace
October twentieth: Third Quarter Company and Monetary Replace
NBTXR3 is a novel, doubtlessly first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that’s administered by way of one-time intratumoral injection and activated by radiotherapy. The product candidate’s bodily mechanism of motion (MoA) is designed to induce important tumor cell demise within the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer reminiscence. Given the bodily MoA, Nanobiotix believes that NBTXR3 could possibly be scalable throughout any stable tumor that may be handled with radiotherapy and throughout any therapeutic mixture, significantly immune checkpoint inhibitors.
NBTXR3 is being evaluated in domestically superior head and neck squamous cell carcinoma (HNSCC) as the first growth pathway. The corporate-sponsored part I dose escalation and dose enlargement research has produced favorable security knowledge and early indicators of efficacy; and a part III world registrational research is deliberate to launch in 2021. In February 2020, america Meals and Drug Administration granted regulatory Quick Observe designation for the investigation of NBTXR3 activated by radiation remedy, with or with out cetuximab, for the therapy of sufferers with domestically superior HNSCC who will not be eligible for platinum-based chemotherapy—the identical inhabitants being evaluated within the deliberate part III research.
Nanobiotix has additionally prioritized an Immuno-Oncology growth program—starting with a Firm-sponsored part I scientific research evaluating NBTXR3 activated by radiotherapy together with anti-PD-1 checkpoint inhibitors for sufferers with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any main most cancers eligible for anti-PD-1 remedy.
Given the Firm’s focus areas, and balanced in opposition to the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration technique with world class companions to increase growth of the product candidate in parallel with its precedence growth pathways. Pursuant to this technique, in 2019 Nanobiotix entered right into a broad, complete scientific analysis collaboration with The College of Texas MD Anderson Most cancers Heart (MD Anderson) for MD Anderson to sponsor a number of part I and part II research to guage NBTXR3 throughout tumor sorts and therapeutic mixtures.
Nanobiotix is a late-stage scientific biotechnology firm pioneering disruptive, physics-based therapeutic approaches to revolutionize therapy outcomes for tens of millions of sufferers; supported by individuals dedicated to creating a distinction for humanity. The corporate’s philosophy is rooted within the idea of pushing previous the boundaries of what’s recognized to increase prospects for human life.
Integrated in 2003, Nanobiotix is headquartered in Paris, France. The corporate additionally has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq International Choose Market in New York Metropolis since December 2020.
Nanobiotix is the proprietor of greater than 30 umbrella patents related to three (3) nanotechnology platforms with purposes in 1) oncology; 2) bioavailability and biodistribution; and three) issues of the central nervous system. The corporate’s sources are primarily dedicated to the event 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 therapy of sufferers with smooth tissue sarcoma below the model title Hensify®.
For extra details about Nanobiotix, go to us at www.nanobiotix.com or observe us on LinkedIn and Twitter
This press launch incorporates sure “forward-looking” statements throughout the that means of relevant securities legal guidelines, together with the Personal Securities Litigation Reform Act of 1995. Ahead-looking statements could also be recognized by phrases corresponding to “at the moment,” “anticipate,” “imagine,” “count on,” “intend,” “on observe,” “plan,” “scheduled,” and “will,” or the detrimental of those and related expressions. These forward-looking statements, that are based mostly on our administration’s present expectations and assumptions and on info presently out there to administration, embrace statements in regards to the timing and progress of scientific trials, the timing of our presentation of information, the outcomes of our preclinical and scientific research and their potential implications, the event and commercialization of NBTXR3, and the execution of the Firm’s growth and commercialization technique. Such forward-looking statements are made in mild of knowledge presently out there to us and based mostly on assumptions that Nanobiotix considers to be cheap. Nevertheless, these forward-looking statements are topic to quite a few dangers and uncertainties, together with with respect to the danger that subsequent research and ongoing or future scientific trials might not generate favorable knowledge however constructive preclinical or early scientific outcome and the dangers related to the evolving nature of the length and severity of the COVID-19 pandemic and governmental and regulatory measures carried out in response to it. Moreover, many different essential components, together with these described in Annual Report on Type 20-F filed with the U.S. Securities and Change Fee on April 7, 2021 below “Merchandise 3.D. Threat Components” and people set forth within the common registration doc of Nanobiotix filed with the French Monetary Markets Authority (Autorité des marchés financiers) below quantity D.21-0272 on April 7, 2021 (a replica of which is offered on www.nanobiotix.com), in addition to different recognized and unknown dangers and uncertainties might adversely have an effect on such forward-looking statements and trigger our precise outcomes, efficiency or achievements to be materially totally different from these expressed or implied by the forward-looking statements. Besides as required by legislation, we assume no obligation to replace these forward-looking statements publicly, or to replace the the reason why precise outcomes may differ materially from these anticipated within the forward-looking statements, even when new info turns into out there sooner or later.