$2.5 billion global licensing, co-development, and commercialization agreement expands worldwide potential of novel radioenhancer NBTXR3- 16.9 months median progression free survival (mPFS) and 23.1 months median overall survival (mOS) following radiotherapy-activated (RT) NBTXR3 in topline Study 102 Phase 1 data in head and neck cancer strengthens hypotheses for pivotal NANORAY-312 trial design
- Promising initial anti-tumor efficacy, median overall survival (mOS) of 23 months, 92% local disease control rate (DCR), favorable safety profile and recommended dose established for NBTXR3 in locally advanced pancreatic cancer
- €50.9 in capital from recent financing including second equity tranche from collaboration partner extends cash runway into 2Q 2025 assuming a milestone
- Successful removal of the EIB cash covenant
- Multiple clinical readouts over the next 18 months and beyond
Conference call and webcast scheduled for
“Our robust NBTXR3 clinical program continues to demonstrate potentially transformative efficacy and well-tolerated safety across indications and patient types, including elderly and vulnerable populations. We are pleased with the encouraging, expanded potential in locally advanced pancreatic cancer supported by initial Phase 1 data from our strategic collaboration with
Third Quarter 2023 Operational Highlights, Subsequent Events, and Pipeline Status and Upcoming Milestones
Nanobiotix announced onJuly 10, 2023 , that it had entered into a global exclusive licensing, co-development, and commercialization agreement withJanssen Pharmaceutica NV , a Johnson & Johnson company, for the investigational, potential first-in-class radioenhancer NBTXR3. The Company has received:$30 million upfront cash licensing fee (received afterJune 30 th, 2023)$5 million first equity tranche received post signing$20.2 million of$25 million second equity tranche received in recent capital raise
The Company remains eligible to receive:- Remaining €4.8 million from second equity tranche, subject to certain conditions
- Up to
$30M in-kind regulatory and development support for study NANORAY-312 provided at Janssen’s sole discretion - Success-based payments of up to
$1.8B and tiered double-digit royalties on net sales of NBTXR3 - 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 - And up to
$220 million , in the aggregate, per indication that may be developed byNanobiotix in alignment with Janssen
- The Company has raised gross proceeds of €50.9 million from a recent financing and second equity tranche from
Johnson & Johnson Innovation, Inc. (JJDC) extends cash runway into 2Q 2025 assuming a development milestone. Gross proceeds are expected to increase to €55.5 million following subscription by JJDC to the remaining placement amount of the second tranche of €4.6 million.
Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): Local Control as Single Agent Activated by Radiotherapy
- NANORAY-312, a pivotal, global and randomized Phase 3 trial evaluating RT-activated NBTXR3 ± cetuximab vs RT ± cetuximab in elderly patients ineligible for cisplatin chemotherapy
- Futility analysis following 25% of planned PFS events expected in H2 2024
- Initial Phase 3 interim efficacy and safety data expected after 67% of planned PFS events in mid-2025
- Study 102, a Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 in patients ineligible for cisplatin chemotherapy or intolerant to cetuximab
- Topline safety and efficacy data presented as an oral presentation at the 65th Annual Meeting of the
American Society for Radiation Oncology (ASTRO) supporting robust anti-tumor efficacy and well-tolerated profile in elderly patients with a high burden of comorbidity (n=56)- 64% CR, 82% ORR in injected-lesion in the evaluable population (n=44) and median duration of response in the NBTXR3-injected lesion not yet reached
- 16.9 months mPFS and 23.1 months mOS in the evaluable population
- Exploratory analyses presented at the 2023 Annual Congress of the
European Society for Medical Oncology (ESMO) investigating additional signs of efficacy provide further support for hypotheses underlying the ongoing registrational Phase 3 NANORAY-312 study design- 42.8 months mOS observed in the 81.8% of evaluable patients who had complete or partial response in the NBTXR3-injected lesion (36/44) compared to 18.1 months in All Patients Treated (n=56)
- Positive correlation associated with objective response, PFS and OS extension with RT-activated NBTXR3 in the injected lesion
- Topline safety and efficacy data presented as an oral presentation at the 65th Annual Meeting of the
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: Priming Immune Response Followed by an Anti-PD-1 Treatment
- Study 1100, a Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 followed by an anti-PD-1 in patients with advanced cancers
- Phase 1 dose expansion data update anticipated 1H 2024
- Ongoing consultation with newly appointed CMO and our new partner on continuing discussions with the FDA for a potential registrational pathway for NBTXR3 in combination with an immunotherapy
Pancreatic, Lung and Others: Expanding NBTXR3 Opportunity Through a Strategic Collaboration with
- Five ongoing clinical trials in advanced solid tumors:
- Advanced Solid Tumors with Lung or Liver Metastases: Phase 1/2 study of RT-activated NBTXR3 plus an anti-PD-1/L-1 immune checkpoint inhibitor (NCT05039632)
- First patient injected in
July 2023
- First patient injected in
- Recurrent or Metastatic Head and Neck Cancer: Phase 2 study of RT-activated NBTXR3 in combination with anti-PD-1 (NCT04862455)
- Inoperable Non-Small Cell
Lung Cancer (NSCLC): Phase 1 study of RT-activated NBTXR3 (NCT04505267) - Pancreatic Cancer: Phase 1 study of RT-activated NBTXR3 after cytotoxic chemotherapy for patients with locally advanced pancreatic cancer (LAPC), (NCT04484909)
- Preliminary Phase 1b dose escalation safety data (
July 30, 2023 cutoff) presented atAmerican Association for Cancer Research (AACR) 2023Special Conference on Pancreatic Cancer support feasibility and promising, durable anti-tumor efficacy of RT-activated NBTXR3- Tolerable safety with local endoscopic injection in 15 patients
- 92% (12/13) injected tumor disease control rate in evaluable patients
- 21 months mOS from diagnosis in evaluable patients
- Additional preliminary signals of promising anti-tumor efficacy from the ongoing Phase 1 study (
September 30, 2023 cutoff) presented at ESMO 2023 potentially help inform clinical trial development- Favorable safety profile and recommended dose established
- 23 months mOS observed in 15 patients
- Preliminary Phase 1b dose escalation safety data (
- Esophageal Cancer: Phase 1 study of RT-activated NBTXR3 in combination with chemotherapy (NCT04615013)
- Multiple clinical milestones in 2024:
- Determination of RP2D in NSCLC trial
- Completion of enrollment in Phase 1b dose expansion trial in pancreatic cancer
- Initial Phase 1b/2 data in esophageal cancer
- Advanced Solid Tumors with Lung or Liver Metastases: Phase 1/2 study of RT-activated NBTXR3 plus an anti-PD-1/L-1 immune checkpoint inhibitor (NCT05039632)
Third Quarter Financial Updates
Cash and Cash Equivalents
Based on the current operating plan and financial projections, we anticipate that the cash and cash equivalents of €38.7 million as of
The gross proceeds of the Global Offering were €31.8 million including the Underwriter’s Option. Adding to this the €19.1 million gross proceeds from the restricted ADSs to be purchased by JJDC in the Concurrent Private Placement, the Company will receive aggregate gross proceeds of approximately €50.9 million (equivalent to approximately
Successful Removal of the EIB Cash Covenant
As previously disclosed, the
Conference Call and Webcast
Details for the call are as follows:
Live (US): 1-888-886-7786
Live
Live (international): 1-416-764-8658
Call me™: click here
Participants can use guest dial-in numbers above and be answered by an operator or they can click the Call me™ link for instant telephone access to the event (dial-out). The Call me™ link will be made active 15 minutes prior to scheduled start time. A live webcast of the call may be accessed by visiting the investors section of the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior the event start. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website.
Participants are invited to email their questions in advance to investors@nanobiotix.com.
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About
Incorporated in 2003,
Disclaimer
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the expected closing of the Concurrent Private Placement and the additional shares to be purchased by JJDC subject to regulatory approval. Words such as “expects,” “intends,” “can,” “could,”, “may,” “might,” “plan,” “potential,” “should,” and “will,” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on our management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including such as market conditions and risks related to Nanobiotix’s business and financial performance. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the
Contacts
VP, Communications +1 (617) 852-4835 contact@nanobiotix.com | Investor Relations Department SVP, Investor Relations +1 (617) 583-0211 investors@nanobiotix.com | |
Media Relations | ||
FR – Ulysse Communication + 33 (0) 6 64 79 97 51 plgermain@ulysse-communication.com | Global – +44 (0) 7413825310 Lvela-reid@lifesciadvisors.com |
Attachment
- 2023-11-13 -- NTBX -- 3Q23 Financial Results -- FINAL
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