Onxeo Reports Third Quarter 2015 Business Update

Continued advancement of key company initiatives and strong cash position
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 published an update on major milestones achieved during the third
quarter of 2015 as well as its consolidated revenues for the period ending
September 30, 2015.

Continued advancement of key R&D programs

  · Livatag® (doxorubicin nanoformulation in Phase III trial for treatment of
hepatocellular carcinoma):
    · Seventh positive DSMB recommendation to continue Phase III clinical trial
    · New patent application with potential to provide new and extended
worldwide protection on the product until 2036

  · Validive®:
    · Presentation of Phase II clinical data at various international
conferences
    · Preparation for next phase of development including guidance from European
and U.S. regulatory agencies

  · Beleodaq®:
    · BELIEF Phase II results published in the Journal of Clinical Oncology
(JCO)
    · Completion of Beleodaq-CHOP Phase I trial, prerequisite for Phase III
first line protocol. Results to be presented at American Society of Hematology
(ASH) Annual Meeting

Evolution of governance with planned succession of chairman Patrick Langlois by
Joseph Zakrzewski in January 2016

“The third quarter of 2015 saw significant advancements in our three orphan
oncology-focused clinical development programs. We maintained good control of
our cash burn,while continuing to fund our clinical developments notably our key
asset Livatag®, a short term and very strong value driver for the company.
Recurring revenues are progressing and we are working closely with our three
U.S. partners - Spectrum Pharmaceuticals, Innocutis/Cipher and Dara BioSciences
- to improve market penetration and build sales momentum. Our ability to
generate revenues from registered products combined with a promising R&D
pipeline in orphan oncology distinguish Onxeo from other European biotech
companies. We believe that this unique value proposition will enable us to
continue growing and realize our goal of becoming a leader in the markets we
serve”, commented Judith Greciet, CEO of Onxeo.

Q3 Financial information

Total revenues for the third quarter of 2015 amounted to €1.1 million, out of
which:

  · €0.7 million of recurring revenues corresponding to product supplies to
commercial partners and royalties on partners’ sales;
  · and €0.4 million of non-recurring revenues, mostly corresponding to the
upfront payment (€0.3 million) received from Bruno Pharmaceutici, our new
partner for Sitavig® in Italy.

Over the first nine months of the year, total revenues stood at €2.7
million, out of which €2.0 million were recurring revenues versus €0.9 million
in 2014. This two-fold increase results from the launch of Beleodaq® and
Sitavig® in the U.S. by partners Spectrum Pharmaceuticals and Innocutis/Cipher
respectively during the summer of 2014, as well as from the initial supply of
Oravig® batches to new U.S. partner Dara BioSciences prior to the launch of the
product in October 2015.

Although overall revenues significantly increased compared to last year,
Beleodaq® and Sitavig® still face significant competition and high barriers to
entry in their respective markets in the U.S. Onxeo’s goal is to foster an
active coordination with its partners in order to ensure the best conditions for
sales uptake for these products in the important U.S. market.

Over the first 12 months of commercialization in the U.S., Beleodaq® net sales
have reached $10 million and Sitavig® sales have reached $2.3 million.

As of September 30, 2015, consolidated cash position amounted to €35.8 million.
Operating cash burn over the quarter stood at €7.1 million, in line with
expectations. Current cash position, taking into account the cashing in of the
2014 R&D tax credit and a new tranche of the Bpifrance grant for Livatag® (total
received in October: €2.9 million), is expected to be sufficient to fund the
Company until mid 2017, including the ability to fully support ongoing 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
final results
Beleodaq® (belinostat): registered in the U.S. in 2nd line treatment of
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=51218571&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=1&md5=3b8532660dabc66badc3518cded4ed52)

To receive our press releases and newsletters, please register
on: http://www.onxeo.com/en/newsletter/ (http://cts.businesswire.com/ct/CT?id=sm
a 
rtlink&url=http%3A%2F%2Fwww.onxeo.com%2Fen%2Fnewsletter%2F&esheet=51218571&newsi
t 
emid=0&lan=en
-US&anchor=http%3A%2F%2Fwww.onxeo.com%2Fen%2Fnewsletter%2F&index=2&md5=f16cfe364
0 
aaacea0fe9bfe7590c9f52)
Follow us on twitter @Onxeo_

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
-france.org (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww
. 
amf-france.org&esheet=51218571&newsitemid=0&lan=en
-US&anchor=http%3A%2F%2Fwww.amf
-france.org&index=3&md5=2f1395c9addd17565ad2e935fc54b34a)) or on the company’s
website
(www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2F
w 
ww.onxeo.com&esheet=51218571&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=4&md5=aaf9b309ae82e928938ca1e6e4a3c196)).
Nathalie Delair-Trepo
Investor Relations
+ 33 1 45 58 76 00
investors@onxeo.com
or
Caroline Carmagnol / Florence Portejoie – Alize RP (France)
onxeo@alizerp.com
+33 6 64 18 99 59 / +33 1 44 54 36 64
or
Kirsten Thomas / Lee Roth – The Ruth Group (U.S.)
kthomas@theruthgroup.com / lroth@theruthgroup.com
+1 508 280 6592 / +1 646 536 7012