Nanobiotix Provides Business Update and Reports Financial Results for the First Half of 2022
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.
- Pivotal Phase 3 study NANORAY-312 actively enrolling elderly LA-HNSCC patients.
- Cash equivalents of €63 million expected to fund operations into Q1 2024.
- Net loss decreased to €26.4 million from €30.4 million year-over-year.
- R&D expenses increased to €16.6 million from €15.5 million year-over-year.
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Pivotal Phase 3 study, NANORAY-312, actively enrolling elderly, LA-HNSCC patients ineligible for cisplatin across ~50 sites as
LianBio enrolls first patient and continues to ramp up site activation inAsia andNanobiotix adds European sites, and begins recruitment in the US
- Recommended Phase 2 dose for I/O combination Study 1100 determined and cohorts in dose expansion phase aligned with planned registration pathway for NBTXR3 plus anti-PD-1 for patients suffering from treatment-resistant recurrent/metastatic head and neck squamous cell carcinoma
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Reported
€63.0 million in cash and cash equivalents as ofJune 30, 2022 which, combined with proposed EIB debt restructuring and existing equity line, is expected to fund development programs into Q1 2024
PARIS &
“I am encouraged by the progress of NANORAY-312 as we, in partnership with
Recent Operational Highlights, Pipeline Status and Upcoming Milestones
Priority Registration Pathway in Locally Advanced Head & Neck Cancer, Local Control as Single Agent Activated by Radiotherapy (RT):
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Randomized first patient in
Europe in pivotal Phase 3 study NANORAY-312, evaluating RT-activated NBTXR3 with or without cetuximab in elderly patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
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Strategic partner
LianBio enrolled the first patient inAsia in Q3 2022, and continues to ramp up site activations in the region to support planned enrollment of ~100 patients in NANORAY-312.
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Initiated clinical site activation for NANORAY-312 in
the United States (US) in Q3 2022, and expect patient enrollment to begin in Q4 22.
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Completed enrollment in Study 102 and provided data as of
February 2022 showing on-going median overall survival of 17.9 months in the all-treated population (n=56) and 23.0 months in the evaluable patients (n=44). Data with minimum follow-up of one year for full study population are expected in mid-2023.
Priority Pathway in Immunotherapy for Recurrent/Metastatic Head & Neck Cancer, Priming Immune Response in Combination with Anti-PD-1 Treatment:
- Received preliminary feedback from FDA regarding a potential Phase 3 registrational program for patients with unresectable locoregional recurrent (LRR) or relapsed or metastatic head and neck squamous cell carcinoma (R/M HNSCC) that developed primary or secondary resistance to previous anti-PD-1/PD-L1 therapy, suggesting a single, randomized, controlled trial including a pre-specified comparative analysis of overall response rate (ORR) may be suitable to support an accelerated approval, subject to confirmation of clinical benefit based on overall survival (OS) results from the same trial
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Completed enrollment and determined recommended phase 2 dose (RP2D) at
33% of tumor volume in all three cohorts of Study 1100, a US Phase 1 dose escalation and dose expansion study evaluating RT-activated NBTXR3 in combination with immune checkpoint inhibitors for patients with advanced cancers. The recommended dose is now being evaluated in the dose expansion part of Study 1100 and will serve as the proposed dose for planned registration pathway in patients with inoperable R/M HNSCC that is resistant to prior immunotherapy
- Amended protocol for the Study 1100 to include one cohort focused on patients with R/M HNSCC that is resistant to anti-PD-1; a second cohort focused on patients with R/M HNSCC that is naive to anti-PD-1; and a third cohort focused on patients with lung, liver, or soft tissue metastases from primary non-small cell lung cancer, malignant melanoma, hepatocellular carcinoma, renal cell carcinoma, urothelial cancer, cervical cancer, or triple-negative breast cancer.
- Expect to provide updated data including approximately ~28 patients at medical conference during the fourth quarter of 2022
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Plan to submit protocol for potential registration pathway for NBTXR3 immunotherapy combination to
US FDA by Q1 23
Expanding NBTXR3 Opportunity, Collaborating with
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Published data from a preclinical study conducted in collaboration between
The University of Texas MD Anderson Cancer Center (MD Anderson) in theInternational Journal of Nanobiotechnology showing that adding NBTXR3 to a combination of radiotherapy, anti-PD-1, and anti-CTLA-4 produced significant antitumor effects against both primary and secondary tumors, improved the mouse survival rate from 0 to50% , and induced long term antitumor memory. These data further the hypothesis that the potential immune priming effects of NBTXR3 could extend beyond anti-PD-1.
- Researchers from MD Anderson published a peer-reviewed clinical case study reporting preliminary data on the first-in-human administration of NBTXR3 for the treatment of pancreatic cancer not eligible for surgery, demonstrating feasibility with no treatment-related toxicity. Determination of the recommended Phase 2 dose (RP2D) for NBTXR3 in pancreatic cancer is expected by the end of 2022.
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Data from a Phase 1b/2 head and neck cancer study in
Asia evaluating NBTXR3 combined with concurrent weekly low-dose cisplatin-containing chemoradiation showed that, in 12 evaluable patients with stage 4 disease, the combination therapy was feasible, had a favorable safety profile for patients with LA-HNSCC, produced a100% disease control rate, and an overall response rate of58.3% .
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Data from a Phase 1b/2 rectal cancer study in
Asia evaluating NBTXR3 combined concurrent chemoradiation showed that, in 31 evaluable patients with unresectable disease, the combination in the preoperative setting was feasible, had a favorable safety profile, and enabled96% of evaluable patients to undergo R0 surgery. The combination therapy produced a100% disease-control rate, a35.5% overall response rate, and a20% pathological complete response rate in 25 patients who underwent surgery.
“Building on initiatives begun in 2021,
Financial Results for the First Half of 2022
Revenue and Other Income: Revenue and other income remained stable for the six months ended
Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical and manufacturing expenses related to the development of NBTXR3. These expenses for the six months ended
Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. Total SG&A expenses for the six months ended
Purchases, fees and other expenses decreased by
Net loss: Net loss attributable to common shareholders for the six months ended
Cash and Cash Equivalents: Cash and cash equivalents as of
Financial Guidance: In
These results are represented in the condensed consolidated financial statements as of
Availability of the half-year financial report
The 2022 half-year financial report has been filed with the French Financial markets authority (Autorité des marchés financiers). It is available to the public on the company’s website, www.nanobiotix.com.
Financial Agenda
About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles 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,
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Disclaimer
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. Such forward-looking statements are made in light of information currently available to us and based on assumptions that
Condensed Consolidated Statements of Operations |
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(unaudited) |
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(Amounts in thousands of euros, except per share numbers) |
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For the six month period ended |
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|
|
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|
||
|
|
|
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Revenue and other income |
|
|
|
|
Revenue |
|
— |
|
10 |
Other income |
|
1,329 |
|
1,309 |
Total revenue and other income |
|
1,329 |
|
1,319 |
Research and development expenses |
|
-16,608 |
|
-15,506 |
Selling, general and administrative expenses |
|
-9,635 |
|
-10,176 |
Other operating expenses |
|
-963 |
|
-5,414 |
Total operating expenses |
|
-27,206 |
|
-31,096 |
Operating income (loss) |
|
-25,877 |
|
-29,778 |
Financial income |
|
2,465 |
|
2,511 |
Financial expenses |
|
-2,940 |
|
-3,152 |
Financial income (loss) |
|
-474 |
|
-640 |
Income tax |
|
-6 |
|
-2 |
Net loss for the period |
|
-26,357 |
|
-30,420 |
Basic loss per share (euros/share) |
|
(0.76) |
|
(0.88) |
Diluted loss per share (euros/share) |
|
(0.76) |
|
(0.88) |
Condensed Consolidated Statements of Financial Position |
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(unaudited) |
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(Amounts in thousands of euros, except per share numbers) |
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As of |
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Total non-current assets |
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7,765 |
|
8,709 |
Cash and cash equivalents |
|
63,021 |
|
83,921 |
Total current assets |
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72,859 |
|
93,060 |
TOTAL ASSETS |
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80,624 |
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101,769 |
Net loss for the period |
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-26,357 |
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-47,003 |
Total shareholders’ equity |
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1,792 |
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26,790 |
Total non-current liabilities |
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36,252 |
|
38,134 |
Total current liabilities |
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42,580 |
|
36,845 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
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80,624 |
|
101,769 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20220928006028/en/
VP, Communications
+1 (617) 852-4835
contact@nanobiotix.com
Nanobiotix Investor Relations
SVP, Investor Relations
+1 (609) 678-7388
investors@nanobiotix.com
Media Relations
+ 33 (0) 6 64 79 97 51
plgermain@ulysse-communication.com
Global –
+44 (0) 7413825310
Lvela-reid@lifesciadvisors.com
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