Onxeo S.A.: Quarterly Information as of March 31, 2015

  · Significant advancements of company programs
    · Livatag®: Opening of new centres and active recruitment in the ReLive
trial
    · Validive®: Presentation of positive preliminary results of the Phase II
trial at ASCO
    · Beleodaq®: new steps in the product development

  · Strengthened internal organization
  · Strong visibility in terms of cash
PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE (http://www.businesswire.com/))--
Regulatory News:

Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ Copenhagen:
ONXEO), an innovative company specializing in the development of orphan oncology
drugs, today publishes the major key milestones achieved during the first
quarter of 2015 and the last few weeks.

“Over the first quarter, Onxeo’s teams have continued to dedicate their efforts
to build our key orphan oncology pipeline. New centers are beeing opened in the
MENA region to optimize the patient recruitment capacities in our phase III
trial with Livatag®. Positive results of our phase II trial with Validive® are
strong enough to support the initiation of a phase III, as recommended by our
expert board, andwill soon be presented at ASCO, the largest worldwide congress
in the oncology field. Lastly Beleodaq® development in PTCL is moving forward to
position the product in first line treatment of rare cancer PTCL.With these
three products, Onxeo capitalizes on major assets with unique features and with
combined sales potential over €1 billion,” comments Judith Greciet, CEO of
Onxeo.

Livatag®

More than 40% of the planned 400 patients have been recruited as of March 31,
2015, within the “ReLive” phase III trial. This trial evaluates Livatag® in the
treatment of primary liver cancer (hepatocellular carcinoma), for which there is
a dire need and a growing demand for innovative treatments. Recruitment will be
accelerated with new clinical sites in Egypt, Saudi Arabia and Lebanon that will
be opened in the following weeks and that will complement existing sites in
Europe and the US. The company plans to announce preliminary results early 2017.

The study safety data are reviewed every semester by a board of independant
experts (DSMB). The 6th DSMB has taken place mid-April with positive outcome on
Livatag® safety based on the review of a substantial number of treated patients
and infusions (- about 35% of patients and 350 infusions).

Validive®

Following positive phase II results of Validive® announced October 2014 , in the
prevention of oral severe mucositis in patients treated for H&N cancer and upon
recommendation of its international key expert board, the company is preparing
the phase III to be initiated by the end of 2015. The phase II data will be
presented at ASCO (American Society of Clinical Oncology) annual conference end
of May in Chicago. This conference is a true tribune and presenting at such
forum enlarges product awareness from the medical community.

Beleodaq®

Beleodaq® (belinostat) is registered in the US for the 2nd line treatment of a
rare hematologic cancer, the peripheral T-cell lymphoma (PTCL), and
commercialized in this territory by Spectrum Pharmaceuticals. The ambition for
Beleodaq® is to position the product in 1st line treatment, an extension of the
current indication, based on a phase III trial combining Beleodaq® with the
current 1st line treatment CHOP (combination of four chemotherapies). This phase
III trial is to start H1 2016, in collaboration with Spectrum Pharmaceuticals.
As a preliminary step, both companies are currently performing a phase I trial
to assess the safety of the drugs combination. Outcome of this phase I trial
should be available in H2 2015.

Beyond PTCL, belinostat’s profile, supported by clinical data, advocates for its
development in new promising orphan oncology indications. The company is
currently reviewing potential indications in order to define the optimal
development plan for belinostat.

Internal organization

Onxeo, established as a French-based company with a branch in Denmark, now
operates as one sole company with a strongly experienced and skilled
international teams. The recent addition of new members in the executive
committee, including new CSO and head of R&D Graham Dixon, already fuels the
organization.

Financials

The consolidated turnover for the first quarter 2015 has increased significantly
compared to same period in 2014, with revenues from licensed products multiplied
by four as a result of the commercialization of Beleodaq® by US partner Spectrum
Pharmaceuticals (launch in the US took place in July 2014).


Consolidated revenues – IFRS – in thousands Euros        Q1 2015     Q1 2014
Recurring revenues from out-licensing agreements         761         158
Non-recurring revenues from out-licensing agreements     157         205
TOTAL                                                    918         363

Non recurring revenues are limited and correspond to the regognition of a
portion of upfront payments received in previous years upon signature of license
agreements concerning Loramyc® et Sitavig®.

Fom a dynamic standpoint, royalties generated by partners’ sales reach €0.6
million, a stable figure compared to Q4 2014 (+2.6%), despite severe winter
weather conditions in the US that have strongly hampered the sales force
promotional activity.

Strongly increased over 2014 through significant milestones payments from
Spectrum and the year-end fund raising, the consolidated cash position stood at
€ 49.4 million as of March 31, 2015. This gives Onxeo a visibility of about two
years and the ability to efficiently support its clinical programs.

About Onxeo

Onxeo has the vision to become a global leader and pioneer in oncology, with a
focus on orphan or rare cancers, through developing innovative therapeutic
alternatives designed to “make the difference”. The Onxeo team is determined to
develop innovative medicines that provide patients with hope and significantly
improve their lives.

Key orphan oncology products at the advanced development stage are:
Livatag® (Doxorubicin Transdrug™): Phase III in hepatocellular carcinoma
Validive® (Clonidine Lauriad®): Phase II in severe oral mucositis: Positive
preliminary top-line results
Beleodaq® (belinostat): registered in the US in peripheral T-cell lymphoma

For more information, visit the
website www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3
A 
%2F%2Fwww.onxeo.com&esheet=51080384&newsitemid=0&lan=en
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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 15, 2015, which is available on the AMF
website (http://www.amf
-france.org (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww
. 
amf-france.org&esheet=51080384&newsitemid=0&lan=en
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website
(www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2F
w 
ww.onxeo.com&esheet=51080384&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=3&md5=fbc7a9e67a8a64ad36f240966820ffbc)).
Onxeo S.A.
Judith Greciet, CEO
j.greciet@onxeo.com
Nicolas Fellmann, CFO
n.fellmann@onxeo.com
+33 1 45 58 76 00
or
Alize RP
Caroline Carmagnol / Sophie Colin, +33 6 64 18 99 59 / +33 1 44 54 36 62
onxeo@alizerp.com