· Onxeo acquires first-in-class, signal-interfering DNA molecule based on one
of the most promising new approaches in cancer treatment
· Acquisition expands Company’s R&D pipeline and opens new opportunities in
orphan oncology indications
· Further development of Validive® to be conducted in partnership
PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE (http://www.businesswire.com/))--
Regulatory News:
Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), an innovative company specializing
in the development of orphan oncology therapeutics, today announced that it has
reached an agreement to acquire DNA Therapeutics, a privately-held, clinical
-stage biopharmaceutical company, for its signal-interfering DNA (siDNA) repair
technology, which is directed at overcoming cancer resistance mechanisms, and
includes lead product candidate DT01. The acquisition, which is subject to
customary closing conditions, is expected to close by the end of March 2016.
The acquisition of DNA Therapeutics continues to demonstrate Onxeo’s commitment
to developing novel orphan oncology drugs that position the Company at the
forefront of scientific research for rare cancers with high, unmet medical
needs, and have the potential to generate significant value for the Company and
its stakeholders by opening other indications and markets.
Under the terms of the agreement, Onxeo is acquiring DNA Therapeutics for an
upfront payment of €1.7 million in common shares at deal closing. Additional
payment will come in the form of milestones including €1 million in cash or in
ONXEO shares, at ONXEO’s sole discretion, upon successful initiation of a Phase
II trial in a selected indication as well as royalty payments on future
commercial sales, up to €25 million per indication developed and approved.
In conjunction with the transaction, in parallel with the contribution in kind,
a large part of DNA Therapeutics’ historical shareholders have agreed to invest
€1 million in cash in Onxeo shares, showing their full support to Onxeo to take
over the development of the siDNA technology.
Interview of Judith Greciet:
http://www.labourseetlavie.com/videos/entreprises-strategie-et-resultats/judith
-greciet-ceo-onxeo-it-s-really-in-our-core
-strategy,2292.html (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%
2
F%2Fwww.labourseetlavie.com%2Fvideos%2Fentreprises-strategie-et
-resultats%2Fjudith-greciet-ceo-onxeo-it-s-really-in-our-core
-strategy%2C2292.html&esheet=51290224&newsitemid=0&lan=en
-US&anchor=http%3A%2F%2Fwww.labourseetlavie.com%2Fvideos%2Fentreprises-strategie
-et-resultats%2Fjudith-greciet-ceo-onxeo-it-s-really-in-our-core
-strategy%2C2292.html&index=1&md5=3e25017b59bdae7d73618cd1b442304f)
The signal-interfering DNA (siDNA) innovation
Through DNA Therapeutics, Onxeo is acquiring a first-in-class clinical signal
-interfering DNA (siDNA) molecule breaking the cycle of tumor DNA repair while
sparing healthy cells. The siDNA technology offers a potential new treatment
option for patients suffering from various types of cancer.
A first-in-human Phase 1/2a trial performed in metastatic melanoma demonstrated
that siDNA molecules showed good tolerance and safety when administered intra
-tumorally and subcutaneously around the tumors. Onxeo now plans to initate the
development of this first-in-class product by the systemic route, and to assess
their safety and tolerance in monotherapy and in combination with other DNA
-damaging agents in various solid tumors. This clinical development will be
implemented after first optimizing the manufacturing process, set to start as
soon as the deal closes.
Judith Greciet, CEO of Onxeo, commented: “The acquisition of DNA Therapeutics
and its siDNA technology represents a significant milestone for Onxeo. We are
excited about this opportunity, which, based on its differentiated mechanism of
action to fight cancer, will be significant in strengthening the level of
innovation in our orphan oncology portfolio and instrumental in delivering value
for our shareholders. The development of new agents specifically targeting DNA
repair while sparing healthy tissues is imperative in the treatment of many
solid tumors. Based on preclinical findings, we plan to evaluate the product in
orphan oncology indications where a systemic application is suitable and for
which there is significant unmet need, for example triple-negative breast cancer
and platinum-resistant ovarian cancer”.
Update on Validive® further steps
Over the course of 2015, Onxeo has continued to advance the clinical development
of Validive® and notably its validation by the US and European regulatory
agencies. Despite recognition from both agencies of Validive®’s interest and
value to patients, these discussions have confirmed that two Phase 3 clinical
trials will be required for registration in the US, which makes the further
clinical program significantly longer and more costly than expected. Therefore,
the Company has decided it is in the best interest of its shareholders to move
forward with this Phase 3 program only with the support of a partner. While
actively seeking for such collaboration, Onxeo will continue to promote the
scientific value of Validive® through presentations at meetings.
“Validive® remains a key asset in our orphan oncology pipeline. We have
successfully developed the product to date and it is ready to enter Phase 3 as
soon as we find the appropriate partner,” commented Judith Greciet. “We are
particularly excited about the acquisition of DNA Therapeutics and its first-in
-class product-candidate which largely complements our core expertise and
scientific ambitions. We believe it will be a tremendous addition to our
pipeline, creating sound opportunity for short-to-long term milestones, adding
value for our shareholders and bringing potentially new treatment options to
patients with rare cancers.”
About DNA repair
Biological responses to DNA damage and approaches to prevent the repair
mechanisms allowing cancer cells to escape treatments have been identified as
one of the most promising new avenues in cancer treatment. Most therapies
against cancer induce DNA damage to tumor cells. DNA damage can also occur
spontaneously in certain types of genetically unstable cancers. Yet cancer cells
have the ability to recognize DNA damage and activate multiple DNA repair
pathways or proteins to survive damages. These DNA repair processes contribute
to cancer aggressiveness and resistance.
About the signal-interfering DNA (siDNA) technology
The siDNA technology developed by DNA Therapeutics, and acquired by Onxeo,
breaks the cycle of cancer DNA repair activities by interfering at the core of
DNA damage and interfering with multiple repair pathways, while sparing healthy
cells. The technology, known as Dbait, was invented by Marie Dutreix, Research
Director at The French National Centre for Scientific Research (CNRS), and Jian
-Sheng Sun, Professor at The French National Museum of Natural History (Museum
National d'Histoire Naturelle) in Paris, and further developed in Dr. Dutreix’s
lab at Institut Curie. DNA Therapeutics was formed as a spin-out of the Institut
Curie and three other French academic institutions.
The siDNA molecule is a short double-stranded DNA molecule that acts as a decoy,
providing a false DNA break signal to attract DNA repair proteins which prevents
the recruitment of repair enzymes to the site of actual DNA damage. Cancer cells
do not have the ability to stop division in the face of DNA damage; they will
continue dividing with the damaged DNA and therefore die. Healthy cells, on the
other hand, will halt cell division until the compound is no longer present and
damaged DNA can be repaired.
In a variety of preclinical animal models, the siDNA molecule demonstrated an
increase in the efficacy of radiotherapy1, radiofrequency ablation2, and
chemotherapy3, and has not lead to toxicity with repeated cycles of treatment,
making it a promising candidate for both monotherapy and combination therapy. A
first-in-human Phase 1/2a trial, “DNA Repair Inhibitor & Irradiation on
Melanoma” (DRIIM; NCT01469455), in patients with metastatic melanoma
demonstrated the safety of local administration of the product. Additionally, no
maximum-tolerated dose (MTD) was identified and the product showed excellent
tumor response correlated with systemic exposure.
About Onxeo
Onxeo is a leading developer of orphan oncology drugs. The Company is focused on
developing innovative therapeutics for rare cancers, one of the fastest growing
markets in the healthcare industry with high, unmet medical needs. Onxeo’s
comprehensive portfolio features a broad orphan oncology pipeline, with three
independent programs in advanced clinical development, including Onxeo’s first
approved orphan oncology drug, Beleodaq®. In addition, Onxeo has successfully
developed and registered two non-cancer products which are currently being
commercialized in the U.S. and Europe. Onxeo’s vision is to become a global
leader and pioneer in oncology, with a focus on orphan or rare cancers, by
developing advanced, effective, and safe therapeutics designed to improve the
lives of patients. The Company is headquartered in Paris, France and has
approximately 50 employees. Onxeo is listed on Euronext in Paris, France
(Ticker: ONXEO, ISIN Code: FR0010095596) and NASDAQ Copenhagen, Denmark (Ticker:
ONXEO).
Onxeo orphan oncology products at the advanced development stage are:
· Livatag® (Doxorubicin Transdrug™): Currently being evaluated in a Phase III
trial (ReLive) in patients with hepatocellular carcinoma (primary liver cancer);
· Validive® (Clonidine Lauriad®): Positive final results from a Phase II trial
in head and neck cancer patients with severe oral mucositis;
· Beleodaq® (belinostat): FDA-approved in the U.S. in 2014 under the agency’s
accelerated approval program as a second-line treatment for patients with
peripheral T-cell lymphoma (PTCL) and currently marketed by Onxeo’s partner in
the U.S., Spectrum Pharmaceuticals; belinostat in combination with CHOP
(BelCHOP) is also in development as first-line treatment for patients with PTCL.
For more information, visit the
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1. Quanz et al., 2009, Berthault et al., 2011, Coquery et al., 2012, Biau et
al., 2014
2. Devun et al., 2014
3. Devun et al. 2011, Herath et al., 2016
Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements concerning Onxeo and its business. Such statements involve certain
known and unknown risks, uncertainties and other factors, which could cause the
actual results, financial condition, performance or achievements of Onxeo to be
materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Onxeo is providing this
communication as of this date and does not undertake to update any forward
-looking statements contained herein as a result of new information, future
events or otherwise. For a discussion of risks and uncertainties which could
cause actual results, financial condition, performance or achievements of Onxeo
to differ from those contained in the forward-looking statements, please refer
to the Risk Factors ("Facteurs de Risque") section of the 2014 Reference
Document filed with the AMF on April 14, 2015, which is available on the AMF
website (http://www.amf
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website
(www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2F
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MAIN TERMS
AND
CONDITIONS OF
THE
CONTRIBUTION
IN KIND
Nature of the The present
transaction transaction is
a contribution in
kind
governed by the
common
rules applicable
to the
contributions in
kind set
forth under
Article L. 225
-147 of the
French
Commercial Code.
Legal The Board of
Framework of Directors of
the ONXEO will make
Issuance use of the
delegation
granted under
the
14th resolution
approved by the
ordinary
and extraordinary
shareholders’
meeting on
May 20, 2015 for
the ONXEO
new shares to be
issued in
consideration for
the
contribution
referred to
in the present
press
release.
Reasons for These ONXEO new
the Offer shares
will be issued in
consideration for
the
contribution of
all the
securities issued
by DNA
THERAPEUTICS and
contributed by
their
holders to ONXEO.
Consideration The transaction
for the will be
Contribution paid through the
issuance
of 553,819 ONXEO
new
shares for an
issuance
price equal to
the
weighted average
market
price of ONXEO on
the
Euronext Paris
market over
the thirty
trading
sessions
preceding
February 29,
2016, i.e.
execution date of
the
agreement between
ONXEO
and the holders
of DNA
THERAPEUTICS’
securities.An
additional
consideration
equal to € 1
million will be
payable in
cash or in ONXEO
shares,
at ONXEO’s sole
discretion, to
the
contributors
subject to
product entering
into at
least one Phase
II
clinical trial.
Additional
payments payable
in cash
will be due to
the
contributors in
case of
commercialization
of the
product on the
basis of
the sums received
in this
respect.
Entitlement The new shares
to New will be
Shares ordinary shares
of the
same class as the
existing
shares. They will
be
entitled to
dividend
rights and be
equivalent
to the existing
shares of
the company as
from the
date of
completion of the
transfer of
ownership of
the DNA
THERAPEUTICS’
securities to
ONXEO.
Listing of The new shares
the New issued as a
Shares result of the
capital
increase will be
subject
to an admission
request
for trading on
compartment
B of Euronext
Paris and on
NASDAQ
Copenhagen. Their
listing will
however occur
only upon
delivery of the
certificate of
filing of
the custodian.
They will
be admitted on
the same
quotation line as
the
existing shares,
will be
totally
assimilated to
them upon
admission to
trading and will
be traded
under ISIN code
FR0010095596 –
mnemonic
code: ONXEO.
Lock-up For a period of 3
to 6
months, depending
on the
contributors, as
from the
closing date, the
contributors will
commit
not to sell all
or part of
the ONXEO shares
they
shall receive in
consideration for
their
contribution.
Conditions The completion of
Precedent the
transaction will
be
subject to the
satisfaction of
certain
conditions
precedent,
including notably
the
issuance by BM &
A, who
has been
appointed as
expert appraiser
for the
contribution in
kind by
order of the
President of
the Commercial
Court of
Paris dated
February 3,
2016, of its
report as
required under
the
applicable
regulations.
Impact on the Portion of the Non Diluted
Company’s group’s -Diluted Basis
Shareholders’ shareholders’
Equity equity per Basis
share
Before € 2.45 € 2.34
issuance of
the new
shares
resulting
from the
capital
increase1 On
an aggregate
number of
shares of
40.552.083
After € 2.41 € 2.31
issuance of
the new
shares
resulting
from the
capital
increase
Impact on Shareholder’s Non Diluted
shareholder’s equity share -Diluted Basis
equity
share basis
Before 1% 0.95%
issuance of
the new
shares
resulting
from the
capital
increase1
After 0.99% 0.94%
issuance of
the new
shares
resulting
from the
capital
increase
MAIN TERMS
AND
CONDITIONS OF
THE PRIVATE
PLACEMENT
Nature of the Capital increase through the issuance of new ordinary
transaction shares, with cancellation of the shareholders’ preferential
right, through a private placement as provided for under L.
411-2 of the French Monetary and Financial Code.
Legal The Board of Directors of ONXEO will make use of the
Framework of delegation granted under the 10th resolution approved by the
the Issuance ordinary and extraordinary shareholders’ meeting on 20 May
2015.
Reasons for This capital increase is made in the context of the
the Offer contribution in kind to ONXEO of all the securities issued
by DNA THERAPEUTICS and is designed to enhance ONXEO’s
financial resources and allow DNA THERAPEUTICS’ shareholders
to support ONXEO’s development.
Beneficiaries The offer is reserved to a restricted circle of investors,
of the Offer composed of those of the DNA THERAPEUTICS’ shareholders
willing to support ONXEO, in particular for the development
of the assets formerly developed by DNA THERAPEUTICS.
Maximum One million Euros (€ 1,000,000)
Amount of the
Offer
Number of New The transaction will be made through the issuance of a
Shares / number of new shares determined on the completion date by
Subscription application of an issuance price equal to the weighted
Price average market price of the ONXEO shares on the Euronext
Paris market during the five trading sessions immediately
preceding the completing date, reduced by a discount of 15%.
Entitlement The new shares will be ordinary shares of the same class as
to New Shares the existing shares. They will be entitled to dividend
rights and be equivalent to the existing shares of the
company as from the date of completion of the transfer of
ownership of the DNA THERAPEUTICS’ securities to ONXEO.
Listing of The new shares issued as a result of the capital increase
the New will be subject to an admission request for trading on
Shares compartment B of Euronext Paris and on the NASDAQ
Copenhagen. Their listing will however occur only upon
delivery of the certificate of filing of the custodian. They
will be admitted on the same quotation line as the existing
shares, will be totally assimilated to them upon admission
to trading and will be traded under ISIN code FR0010095596 –
mnemonic code: ONXEO.
Lock-up For a period of 3 months as from the completion date, the
investors will commit not to sell all or part of the ONXEO
shares they will have subscribed though this private
placement. Then, as from the expiration date of this first
period, the investors will commit not to sell (i) more than
a third of their shares per month and (ii) more than a third
of the weighted average of the daily transactions over the
preceding thirty trading sessions, during any given trading
session.
Impact on the The impact on the shareholders’ equity and on the share of
Company’s any given shareholder in the Shareholders’ Equity will be
Shareholders’ determined on the new shares issuance date, based upon the
Equity and on definitive issuance price and the number of issued shares.
the share of
any given
shareholder
in
Shareholder’s
Equity
Completion It is contemplated that the present private placement will
be completed simultaneously to the contribution in kind of
all the DNA THERAPEUTICS’ securities to ONXEO.
In accordance with the provisions of article L. 411-2 of the French Monetary and
Financial Code and article 211-2 of the General Regulations of the French
Financial Market Authority (Autorité des marchés financiers, AMF), this
transaction is not subject to a prospectus to be approved by the AMF as the
total amount of the transaction is between €100,000 and €5,000,000 and
represents less than 50% of Company total share capital.
1 On an aggregate number of shares of 40.552.083
Contacts
Nathalie Delair-Trepo, + 33 1 45 58 76 00
Investor Relations, Onxeo
investors@onxeo.com
or
Caroline Carmagnol and Florence Portejoie – Alize RP (France)
onxeo@alizerp.com
+33 6 64 18 99 59 / +33 6 47 38 90 04
or
Kirsten Thomas / Lee Roth – The Ruth Group (U.S.)
kthomas@theruthgroup.com / lroth@theruthgroup.com
+1 508 280 6592 / +1 646 536 7012
Onxeo Announces Acquisition of DNA Therapeutics and Provides Update on Validive® Development Plan
| Source: Onxeo SA
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