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Nanobiotix S.A. (Euronext: NANO / ISIN: FR0011341205) is a leading clinical-stage nanomedicine company specializing in the development of groundbreaking approaches for cancer treatment. The company's core technology, NanoXray, augments the effectiveness of radiotherapy, offering a more efficient treatment option for cancer patients. The innovative NanoXray products are designed to be compatible with existing radiotherapy treatments and aim to treat a broad spectrum of solid tumors, such as soft tissue sarcoma, head and neck cancers, liver cancers, prostate cancer, breast cancer, and glioblastoma.
The primary product candidate, NBTXR3, is currently undergoing evaluation for its efficacy in treating soft tissue sarcoma, head and neck cancers, prostate cancer, and liver cancers (both primary and metastases). Additionally, Nanobiotix has partnered with PharmaEngine in Taiwan to conduct trials for head and neck cancer and rectal cancer in the Asia Pacific region.
Nanobiotix has also embarked on a preclinical research program in immuno-oncology, further expanding its portfolio and potential for transformative cancer therapies. NBTXR3 works by magnifying the effects of radiotherapy within tumor cells, thereby enhancing cancer treatment without increasing the dose to surrounding healthy tissues.
Recently, Nanobiotix has been focused on validating the safety and efficacy of RT-activated NBTXR3 by moving to global registration for LA-HNSCC, accounting for the majority of its operational and financial resources. The company plans to provide an updated global development plan for NBTXR3 after further alignment with the Joint Steering Committee (JSC).
In terms of financial performance, Nanobiotix has laid out a cautious strategy, ensuring that it remains well-funded to support ongoing and future operations. Their forward-looking statements highlight the potential risks and uncertainties that could affect their business and financial performance.
For the latest updates, Nanobiotix has scheduled a conference call and webcast on May 22, 2024, at 8:00 am EDT / 2:00 pm CEST. It continues to engage the market, providing transparency to shareholders through various media and regular updates on their progress and milestones.
To keep up with the latest news, visit www.nanobiotix.com.
Nanobiotix has announced the successful completion of the dose escalation phase in a phase 1 study, evaluating NBTXR3 for patients with locally advanced pancreatic adenocarcinoma. The recommended phase 2 dose was set at 42% of the gross tumor volume, with ongoing recruitment for the expansion phase. Encouraging results include a partial response in one patient and successful local control in another leading to resectability. Safety data and early efficacy findings will be presented at a medical congress in 2023, bolstering confidence in NBTXR3's potential impact against this challenging cancer.
Nanobiotix announced promising results from its phase 1 immunotherapy study (Study 1100) involving NBTXR3 activated by radiotherapy and followed by anti-PD-1 therapy. The study demonstrated feasibility and tolerability, establishing a recommended phase 2 dose at 33% of gross tumor volume. Of 21 evaluable patients, 71.43% showed objective reduction in target lesions, with 42.86% achieving over 30%. Durable systemic disease control was observed in 38.10% of patients for over six months. A registrational phase 3 protocol submission to the FDA is planned for Q1 2023.
Nanobiotix has established the recommended Phase 2 dose for NBTXR3 combined with anti-PD-1 therapy for various cancers. Updated safety and efficacy data from Study 1100 will be presented at the SITC 2022 on November 10. The company has strengthened its scientific advisory board with twelve global medical experts, enhancing its strategic capabilities. As of September 30, 2022, Nanobiotix reported €53.5 million in cash, extending its financial runway into Q1 2024. A debt restructuring agreement with the European Investment Bank has also been finalized.
Nanobiotix announced key updates as of October 31, 2022. The company has 34,875,872 outstanding shares and a total of 36,286,313 theoretical voting rights. The exercisable voting rights amounted to 36,273,212. The firm focuses on innovative therapeutic solutions for cancer treatment, particularly through its lead product NBTXR3, designed to enhance tumor control. These developments underline Nanobiotix's commitment to improving patient outcomes in oncology.
Nanobiotix announced the formation of a Scientific Advisory Board comprising twelve expert oncologists from the US and Europe to support the development of its lead therapeutic candidate, NBTXR3. The board's diverse expertise aims to enhance clinical trial strategies and improve patient care. Leonard Farber, MD, highlighted the necessity of multidisciplinary knowledge for advancing this innovative cancer treatment. NBTXR3 targets solid tumors, with an emphasis on head and neck cancers, leveraging a novel physics-based approach.
Nanobiotix, a late-stage clinical biotechnology company, announced participation in a fireside chat at the Jefferies London Healthcare Conference on November 15, 2022. Laurent Levy, co-founder and chairman, along with Bart Van Rhijn, CFO, will speak at 5:00 PM GMT/12:00 PM ET. The event will be webcast live and available for replay for 30 days. The company is focused on innovative physics-based therapies, including NBTXR3, to improve treatment outcomes in cancer patients, particularly those with head and neck cancers.
Nanobiotix will release its financial results for Q3 2022 on November 9, 2022, after US market close. A conference call is scheduled for November 10, 2022, at 8:00 AM ET, where CEO Laurent Levy and CFO Bart Van Rhijn will discuss the results and company updates. The call will be accessible via the company's website, allowing participants to register in advance. Nanobiotix focuses on innovative cancer therapies, particularly through its lead product, radiotherapy-activated NBTXR3, targeting solid tumors.
Nanobiotix (NASDAQ: NBTX) has signed a final restructuring agreement with the European Investment Bank (EIB) to realign approximately €30.7 million in debt obligations with its commercialization timelines. The agreement allows deferral of €25.3 million in principal repayments until June 2029 and restructures €5.4 million in accrued interest as payment-in-kind until October 2024. Additionally, a new €20 million milestone payment is set for June 2029, contingent on commercial success. This restructuring aims to support the anticipated revenue generation from the company’s lead product, NBTXR3, in cancer treatment.
Nanobiotix reported updated information regarding its outstanding shares and voting rights as of September 30, 2022. Currently, there are 34,875,872 shares outstanding, with a total of 36,277,898 theoretical voting rights and 36,261,825 exercisable voting rights. This data is crucial for ensuring transparency for shareholders and aligns with the French regulatory requirements.
Nanobiotix announced operational progress in its pivotal Phase 3 study, NANORAY-312, focusing on elderly patients with locally advanced head and neck cancer. The first patient has been enrolled in Asia, with plans to recruit approximately 100 patients globally. Financially, the company reported €63 million in cash equivalents as of June 30, 2022, and expects funding through Q1 2024 due to a debt restructuring with the EIB. Despite a stable revenue of €1.3 million, R&D expenses rose to €16.6 million. The net loss decreased to €26.4 million, or €0.76 per share, compared to €30.4 million in 2021.
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