- On-track to activate first US clinical trial sites in on-going
pivotal phase III global registration study, NANORAY-312, in
locally advanced head and neck squamous cell carcinoma (LA-HNSCC)
in Q3 2022
- Received preliminary feedback from FDA informing development of
pivotal Phase III protocol for NBTXR3 in combination with anti-PD-1
therapy, protocol submission planned in Q1 2023
- Cash position totaling €70.6 million as of March 31, 2022
- Prioritizing research and development programs to reduce
operating expenses and establishing flexible equity financing line
that can be accessed at the Company’s discretion to extend
operating runway into Q4 2023
- Exploring broader debt restructuring to potentially extend
operating runway further
Regulatory News:
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, cash position (unaudited) for the first quarter of 2022,
and extension of operating runway into Q4 2023.
First Quarter Operational Highlights
Priority Registration Pathway in Head
& Neck Cancer, Local Control as Single Agent Activated by
Radiotherapy
- Randomized first patient in pivotal phase III study NANORAY-312
evaluating radiotherapy (RT) activated NBTXR3 with or without
cetuximab in elderly patients with locally advanced head and neck
squamous cell carcinoma
- Strategic partner, LianBio, expected to activate first clinical
trial site and randomize first patient in Asia in H2 2022
- US site activation and patient enrollment expected in Q3 2023
in line with prior expectations
- Completed enrollment in Study 102, a phase I study evaluating
RT activated NBTXR3 in elderly LA-HNSCC patients ineligible for
cisplatin and intolerant to cetuximab and provided data 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)
- Preparing protocol amendment reducing planned post-treatment
follow-up period from 24 months to 12 months to provide a mature
dataset while reducing the overall study duration
- Final Study 102 data expected mid-2023
Priority Pathway in Immunotherapy for
Advanced Cancers, Priming Immune Response in Combination with
Anti-PD-1 Treatment:
- Received preliminary feedback from the U.S. Food and Drug
Administration (FDA) regarding a potential Phase III registration
program in patients with unresectable relapsed or metastatic Head
& Neck Squamous Cell Carcinoma (R/M HNSCC) who developed
primary or secondary resistance to previous anti-PD-1/PD-L1 therapy
- Comments provided by the FDA suggest a single, active-control
trial including a pre-specified comparative analysis of overall
response rate (ORR) may be suitable to support an accelerated
approval, with verification of clinical benefit based on overall
survival (OS) results from the same trial
- Based on guidance provided by FDA, Nanobiotix plans to prepare
and submit a protocol and statistical analysis plan for review in
Q1 2023
- Expansion Phase added to Study 1100 evaluating NBTXR3 in
combination with anti-PD-1 therapy in three cohorts, including one
cohort focused on R/M HNSCC patients that are resistant to prior
anti-PD-(L)-1 therapy
- Update expected on Study 1100 in Q4 2022
Expanding NBTXR3 Opportunity,
Collaborating with World-Class Partners to Validate Tumor-Agnostic,
Combination-Agnostic Therapeutic Profile:
- Published data from a preclinical study conducted in
collaboration between The University of Texas MD Anderson Cancer
Center (MD Anderson) in the in the 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 to 50%, and induced long term antitumor
memory, further supporting the hypothesis that the potential immune
priming effects of NBTXR3 extends beyond anti-PD-1.
- Researchers from MD Anderson published 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 recommended phase II dose for NBTXR3 in
pancreatic cancer expected in H2 2022
“During the first quarter of 2022, we made significant progress
in advancing our priority development programs. Having already
provided clinical validation of the novel, physics-based MoA of
NBTXR3 in soft tissue sarcoma, showed the potential survival
benefit as a monotherapy in head and neck cancer, replicated the
high response rate across multiple cancer types, and reported data
suggesting the potential to combine with and expand the benefits of
checkpoint inhibitors to more patients, we remain steadfast in our
conviction that NBTXR3 has the potential to radically impact the
future of cancer care for millions of patients,” said Laurent Levy,
co-founder and chairman of the executive board of Nanobiotix. “To
ensure this fundamental value as we continue to see unprecedented
deterioration in the capital markets, we are taking proactive steps
to adjust our cost structure, reduce spend, and focus our
operational activities on building a head and neck franchise. We
believe that by beginning with single agent approval in locally
advanced head and neck cancer and expanding through combinations
across treatment modalities will create a model that can be
replicated across solid tumor indications, improving patient
outcomes and driving significant value to shareholders.”
Prioritizing Registration Programs and Reducing Operating
Expenses
Nanobiotix is pursuing various initiatives to reduce operating
costs while maintaining targeted research efforts focused on the
continued execution of its pivotal phase III study in LA-HNSCC, the
continuation of I/O combination Study 1100, and the development of
a registration pathway in I/O combination therapy while leveraging
its on-going strategic collaboration with MD Anderson to validate
the feasibility of future development opportunities. In
prioritizing late-stage programs and strategic collaborations, the
company plans to deprioritize direct funding in several areas,
including:
- Modifying or postponing additional company-sponsored
clinical trials, including planned amendments to Study 102
reducing follow-up time from 24 to 12 months and postponement of
post-marketing studies previously planned in soft tissue
sarcoma
- Reducing on-going and previously planned preclinical
research, including development activities related to the
Company’s subsidiary, Curadigm
- Adjusting planned manufacturing activities to support
revised preclinical and clinical development activities
- Adapting infrastructure, including reducing satellite
office facilities and implementing a temporary hiring-freeze
These initiatives are expected to reduce the Company’s cash burn
by approximately €12-15 million, which will be reflected in
Nanobiotix’ financial outlook for 2022 and 2023.
First Quarter Financial Updates
Nanobiotix reported cash, cash equivalents, and short-term
investments totaling €70.6 million as of March 31, 2022, compared
to €83.9M as of December 31, 2021. To supplement its financial
resources, Nanobiotix has established an equity financing line with
Kepler Cheuvreux. This line of financing will provide optionality
and create near-term flexibility, if needed, as the company
continues efforts to reduce operating expenses and, potentially,
restructure its existing debt facilities. Based on the current
operating plan and financial projections, Nanobiotix anticipates
that the available capital will fund its operations into, at least,
the fourth quarter of 2023.
Implementing Equity Line Financing to
Strengthen Financial Flexibility
In accordance with the terms of this agreement, Kepler Cheuvreux
committed to underwrite up to 5,200,000 shares representing, for
information purposes, an issued amount of approximately €25m1, over
a maximum timeframe of 24 months, provided the contractual
conditions are met. Should Nanobiotix choose to use this facility,
the shares will be issued based on the volume-weighted average
share price on Euronext: Paris for the two trading days prior to
issuance, minus a maximum discount 5.0%. In addition to controlling
if and when to access capital, including consideration of current
share valuation, Nanobiotix has guaranteed access to capital to
fund operations along with control over potential dilution despite
any sustained turbulence in the broader market, while retaining the
right to suspend the implementation of the equity line or terminate
this agreement at any time, free of charge.
Agreements have been set up based on and in accordance with the
21st resolution from the annual shareholders meeting of April 28,
2021. Should Nanobiotix choose to use this facility, the number of
shares issued under this agreement and admitted to trading will be
disclosed on the Company’s website. In accordance with the
provisions of the General Regulations of the French Financial
Markets Authority (“AMF”), this financial operation will not be
subject to a prospectus requiring a visa from the AMF.
If this financing line were to be fully used with the issue of
5,200,000 shares, a shareholder holding 1.00% of the capital of
Nanobiotix before it is set up, would see their stake reduced to
0.87% of the capital on an undiluted basis and to 0.84% of the
capital on a fully diluted basis.
This operation was advised and structured by Vester Finance.
Kepler Cheuvreux is the sole underwriter of the facility and is not
expected to maintain ownership of any shares issued in conjunction
with the equity line.
Conference Call and Webcast
Nanobiotix will host a conference call and live audio webcast on
Thursday, May 19, 2022, at 2:00 PM CET/8:00 AM EDT, prior to the
open of the US market. During the call, Laurent Levy, chief
executive officer, and Bart Van Rhijn, chief financial officer,
will briefly review the Company’s first quarter results and provide
an update on business activities before taking questions from
analysts and investors. Investors are invited to email their
questions in advance to investors@nanobiotix.com
Details for the call
are as follows:
Live (US/Canada): + 16467413167 Live France:
+ 33170700781 Live (international): + 44 (0) 2071 928338 Conference
ID: 7795306
A live webcast of the call may be accessed by visiting news and
events page in the investors section of the company's website at
www.nanobiotix.com. A replay of the webcast will be available
shortly after the conclusion of the call and will be archived on
the company's website for 90 days.
2022 Financial Agenda
- June 23, 2022 – Annual General Meeting, Paris, France
- September 7, 2022 – 2022 Half-Year Corporate and Financial
Update
- November 9, 2022 – Third Quarter 2022 Corporate and Financial
Update
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, 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.
About NANOBIOTIX
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 is leveraging its proprietary nanoparticle platform,
including its lead product candidate, radiotherapy activated
NBTXR3, to develop a pipeline of therapeutic options designed to
enhance local and systemic control of solid tumors with an initial
focus on the treatment of head and neck cancers.
For more information about Nanobiotix, visit us at
www.nanobiotix.com or follow us on LinkedIn and Twitter.
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, 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 8, 2022 under
“Item 3.D. Risk Factors” and those set forth in the universal
registration document of Nanobiotix filed with the French Financial
Markets Authority (Autorité des marchés financiers – the AMF) on
April 8, 2022 (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.
________________________ 1 On the indicative basis of the
weighted average price of the last two trading sessions of the
Nanobiotix share on May 17, 2022
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220518006111/en/
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 Stefanie Tuck +1 (917) 390-1394
Stefanie.tuck@porternovelli.com
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