Regulatory News:
NANOBIOTIX (Paris:NANO) (Euronext: NANO ? ISIN: FR0011341205),
a late clinical-stage nanomedicine company pioneering novel approaches
for the local treatment of cancer, provides its activities and
achievements during 2014 and an overview of anticipated 2015 events
including the financial calendar. The Company made major clinical and
financial progress, including broadening of indications and strategic
plans across Europe, Asia and the US.
Highlights
-
Reported positive results from the Phase I clinical study on NBTXR3 in
soft tissue sarcoma (STS) demonstrating a good safety profile and
proof of concept -
Received approval to start a pivotal European Phase II/III clinical
trial in STS; the last trial before registration which is expected in
2016 -
Expanded the clinical development program with new high potential
indications in the US and Europe : liver cancers and prostate cancer,
in parallel with STS and head & neck trials already underway in Europe -
Announced the Company?s partner for Asia, PharmaEngine, and decided to
participate in the STS registration trial, potentially shortening the
time to market in Asia -
Broadened the Company?s international strategy through the creation of
a US affiliate to advance internally the development of NBTXR3 in the
US for different indications prior to potential partnering -
Strengthened the Company?s financial position; a rights issue and a
private placement totaled ?38.5m [?28.1m + ?10.4m] -
Outlook for 2015 : extended clinical pipeline and preparation for
commercialization of NBTXR3
Laurent Levy, CEO of Nanobiotix said: ?2014 has been a pivotal year
for the Company, with significant progress in clinical development,
where we jumped from an early clinical stage to late clinical stage.
This has impacted our visibility and exposure from a financial and
industrial point of view allowing us to accomplish two capital raises
this year. We are now in a position to create value through the
expansion of the indications and geographical area of development for
the lead product, NBTXR3. As a result, 2015 is expected to be a year of
further significant progress with intermediary clinical results, US
corporate developments and launch of new indications; all building on
the successes of 2014 and preparing for the final steps of CE marking by
the end 2016 required before commercial launch.?
Overview
Expansion of clinical development programme
The company is developing three different products that can be
administered either by direct injection into the tumor (NBTXR3),
intravenous injection (NBTX-IV) or topical application to fill tumor
cavities just after tumor surgery (NBTX-TOPO).
NBTXR3 is the first product of the NanoXray portfolio to reach clinical
development. The product comprises nanoparticles which can be injected
directly into tumor. With the application of radiotherapy, these
nanoparticles absorb X-rays which significantly enhances the radiation
dose within the cancer cells without increasing the dose to the
surrounding healthy tissues. Currently, NBTXR3 is classified as a
medical device in Europe and a drug in the United States (US).
Soft tissue sarcoma (STS): green light to start registration trial
In June 2014 during ASCO, the Company presented positive Phase I
clinical study results for NBTXR3, demonstrating feasibility and safety
of intratumoral injection of the product followed by radiotherapy in
patients with locally advanced STS. In addition to the feasibility and
safety data presented, promising signs of efficacy have been
demonstrated.
The positive results led the French National Security Agency for
Medicines and Health Products (ANSM) to allow Nanobiotix to enter into a
Phase II/III pivotal trial, which is the final step before registration
(CE mark).
This study started end 2014 in France and will be broadened out to 25-30
sites in Europe once further authorizations are received.
This international multi-center pivotal study is expected to be
completed towards the end of 2016 with interim results in mid-2016.
In the Asia-Pacific region, Nanobiotix?s partner, PharmaEngine intends
to participate in the pivotal study by opening clinical sites in several
Asia-Pacific countries.
In the US, depending on the interim clinical results, expected mid-2016,
the Company will decide if doable to expand the development of NBTXR3
through a bridge study in this indication to access this market.
Head & Neck cancer: new sites opened in Spain
NBTXR3 is also in development for elderly patients with locally advanced
head and neck cancer. The aim is the decrease of the tumor size and the
preservation of the local functions. Nanobiotix is currently conducting
a pilot trial for this indication, for which interim results are
expected in H1 2015.
Patients are being assessed on their tolerance of the product with the
aim of providing better control of the disease and an improved quality
of life. In 2014, two new sites were opened in Spain for this pilot
trial.
New Indications with High Potential: Liver Cancers and Prostate Cancer
Liver cancers
Liver cancers are potentially the largest indication for NBTXR3.
Nanobiotix is already pursuing the non-clinical evaluation phase of
NBTXR3 in primary liver cancer, and as part of its expanded development
plan, is also evaluating the compound in liver metastases (metastases
arising from colorectal cancers, breast cancer, etc.).
The inclusion of liver metastases would more than double the total
potential treatable population of patients for this product.
Nanobiotix plans to initiate clinical trials in this indication in the
second half of 2015 and will include patient populations with both
Primary liver cancer and liver metastases. For this patient population,
the aim of treatment is to increase and prolong patients? survival
rates. This program is being supported with a ?2.8m grant from Bpifrance
through the NICE project..
Prostate cancer
The Company is also seeking to develop NBTXR3 for patients with high
risk prostate cancer, with the aim of providing effective tumor control
combined with tumor destruction. It represents a significant potential
new market for the product. The planned pilot trial is expected to start
in the second half of 2015 and will involve approximately 24-30 patients
that are newly diagnosed with high risk prostate cancer.
Potential further indications
NBTXR3 could be also developed in other indications as the potential is
broad especially for esophagus cancer, glioblastoma, cervix cancer, etc.
Broader International Strategy
Nanobiotix is pursuing a standalone development and commercialization
strategy for its lead product NBTXR3 in Europe.
Following a private placement to a US investor in November 2014, the
Company now has the financial means to adopt a similar independent
strategy for the development of NBTXR3 in the US.
As part of the international strategy, in September, Nanobiotix opened
an affiliate office in Cambridge, MA. The affiliate is headed up by
Patrick Tricoli, Vice President Corporate Development for Nanobiotix.
Patrick has over 25 years? experience within the pharmaceutical industry
and joined Nanobiotix from Sanofi where he held a number of positions in
both Corporate and Research and Development departments.
In the Asia-Pacific region, Nanobiotix is already partnered with
PharmaEngine. PharmaEngine joined Nanobiotix?s pivotal trial for NBTXR3
in STS to accelerate its development in Asia-Pacific.
Strengthened Financial Position
Capital raisings
During 2014, the Company completed two capital raises, totaling ?38.5m,
with the potential for another ?24.1m (if all warrants attached to the
shares issued during the second capital raise are exercised, and the
Company exercises a supplemental tranche).
The first fund raising was completed in March 2014 and raised ?28.1m
based on the share price of ?10.60. There was a significant demand for
shares from investors in Europe and thus the placement was expanded,
with an additional 15% of new equity made available, corresponding to
the full exercise of the extension clause.
More recently, in November, the company attracted a new investor from
the US, Capital Ventures International, with a private placement of new
shares with warrants associated for a total amount of ?10.4m (at ?15.99
per share). A potential supplemental amount of up to ?14.1m if all
warrants are exercised (?21.63 per share) and a commitment to purchase
an additional tranche of up to ?10 million at the Company?s discretion,
subject to certain conditions, may be received.
The underlying rationale for this second capital raising was to i)
enable the Company to expand the indications and the geographical area
for its lead product NBTXR3 ii) provide the financial visibility to
drive a standalone strategy in US until reconsidering partnering options
and iii) structure capital through a new US based shareholder.
The foregoing transactions are described in more detail in the press
releases published by the Company at the time of their completion.
Capital Market Index
Nanobiotix is included in the Next Biotech Index in Europe and to the
CAC® PME Index which tracks the performance of 20-40 French PEA PME
eligible companies. Nanobiotix? inclusion on the PME index is helpful in
raising the Company?s profile and the stock?s visibility.
Stock market performance
Major progress made by Nanobiotix in 2014 led to a significant increase
of its market capitalization. January 2nd, 2015: ? 247
million against ? 52 million January 2nd, 2014.
Outlook for 2015
Nanobiotix is in a strong financial position to pursue its standalone
strategy in both Europe and US.
In 2015, further clinical progress is expected:
The head and neck pilot trial is expected to report intermediary results
at the end of H1 2015. In the second half of 2015, the liver cancers and
high risk prostate cancer programs are anticipated to enter the clinical
stage.
The STS pivotal trial will report interim data in the first half of
2016, and the full read out is expected at the end of 2016.
In view of this the Company has already started to work on the most
appropriate industrialization, commercialization and reimbursement
routes for expected CE mark at the end of 2016.
The company is also preparing for the future by expanding its pipeline
with two other NanoXray products (NBTX-TOPO and NBTX-IV) and beyond.
The company expects to grow its affiliate in US in order to sustain the
first product and corporate development.
Financial Calendar
Nanobiotix will announce its financial and operating results according
to the following indicative calendar:
- February 27, 2015 – Annual Turnover
- April 30, 2015 – Annual results
- May 15, 2015 – Turnover of the first quarter
- July 15, 2015 – Half yearly turnover
- August 31, 2015 – Half yearly results
- November 13, 2015 – Turnover of the third quarter
- Before June 30, 2015 – Annual General Assembly Paris, France
Notes to Editors
Terms of the Private Placement in November 2014
A total of 650,000 ordinary shares (the ?New Shares?) were issued to CVI
in the private placement, representing around 4.85% of the outstanding
shares prior to the private placement.
In accordance with the 17th resolution of Nanobiotix? general
shareholders meeting held on June 18, 2014, the price of the placement
has been set at ?15.99 per New Share. This price represents a 15%
discount to the volume weighted average price (VWAP) of the last 5
trading days preceding the pricing date.
One warrant is attached to each New Share, entitling CVI to subscribe,
at any time and in one or more installments until June 30, 2016, for one
additional share per warrant, i.e. a maximum of 650,000 additional
ordinary shares (the ?Additional Shares?) at a price of ? 21.63 per
share (i.e., 115% of the arithmetic average of the VWAP of the Company’s
shares on each of the five (5) trading days immediately preceding the
pricing date). The warrants will be immediately detached (détachés) from
the New Shares as from their issuance and will be credited in registered
form (nominatif). The Company may require CVI to exercise the warrants
if the daily VWAP of the Company’s ordinary shares shall exceed 150% of
the exercise price of the warrants, i.e., ? 32.45, for any twenty (20)
out of thirty (30) consecutive trading days before the expiration of the
warrants.
The warrants? exercise price will be automatically adjusted downwards
(but not to be less than 95% of the arithmetic average of the VWAP of
the Company’s shares on each of the five (5) trading days immediately
preceding the pricing date) in the event of any subsequent new issue of
shares or securities giving access to the capital of the Company on the
basis of a price per share lower than the exercise price of the warrants
(excluding any options or other incentive shares to employees and
executives of the group not to exceed 5% of the capital).
Finally, CVI has committed (subject to certain conditions) to purchase a
third tranche of up to 10 million ? of additional ordinary shares, not
to exceed 650,000 shares, if the Company shall decide in its discretion
to issue them to CVI in the period from November 25, 2015 to March 31,
2016, at a price equal to 85% of the arithmetic average of the VWAP of
the Company’s shares on each of the five (5) trading days immediately
preceding their issue date, but in no event greater than the VWAP of the
Ordinary Shares on the trading day immediately preceding the applicable
date.
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late
clinical-stage nanomedicine company pioneering novel approaches for the
local treatment of cancer. The company?s first-in-class, proprietary
technology, NanoXray, enhances radiotherapy energy with a view to
provide a new, more efficient treatment for cancer patients. NanoXray
products are compatible with current radiotherapy treatments and are
meant to treat potentially a wide variety of cancers including Soft
Tissue Sarcoma, Head and Neck Cancer, Liver Cancers, Prostate Cancer,
Breast Cancer, Glioblastoma, etc., via multiple routes of administration.
Nanobiotix?s lead product NBTXR3, based on NanoXray, is currently under
clinical development for Soft Tissue Sarcoma and locally advanced Head
and Neck Cancer. The company has partnered with PharmaEngine for
clinical development and commercialization of NBTXR3 in Asia.
The company, based in Paris, France, opened an affiliate office in the
Boston area of the US in September, 2014.
Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN:
FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP).
Important Information
This press release contains certain forward-looking statements
concerning Nanobiotix and its business, including the Company?s
strategy, plans for the global development of the Company?s products,
investment plans and calendar for regulatory events, the market
potential for certain products, as well as other forward looking
information and statements. Such forward-looking statements are based on
assumptions that Nanobiotix considers to be reasonable. However, such
forward-looking statements are, by their nature, subject to a number of
important risks and uncertainties, such as those described in the in the
reference document of Nanobiotix registered on November 25, 2014 with
the AMF under number R.14-071 (a copy of which is available on www.Nanobiotix.com)
and to the development of economic conditions, financial markets and the
markets in which Nanobiotix operates, and actual results or events may
differ materially from those expressed or implied in the forward-looking
statements. These forward-looking statements are also subject to risks
not yet known to Nanobiotix or not currently considered material by
Nanobiotix. The occurrence of all or some of such risks, or other
events, could cause actual results, financial conditions, performance or
achievements of Nanobiotix to be materially different from the plans,
objectives and expectations expressed or implied in such forward-looking
statements. Forward-looking statements speak only as of the date on
which they are made, and Nanobiotix undertakes no obligation to update
or revise any of them, whether as a result of new information, future
events or otherwise, except as required by law.
This press release is for information purposes only and does not, and
shall not, in any circumstances, constitute a public offering by
Nanobiotix nor a solicitation of an offer to subscribe for securities in
any jurisdiction, including France. In particular, this press release
and the information contained herein do not constitute an offer or
solicitation of an offer to subscribe for securities in the United
States or any other jurisdiction. The shares of Nanobiotix have not been
and will not be registered under the U.S. Securities Act of 1933, as
amended.
