Onxeo First Quarter 2016 Financial information and Business Update

Pipeline reinforced through major development milestones on existing assets and
new product acquisition
PARIS & COPENHAGUE, Danemark--(EON: Enhanced Online News)-- Regulatory News:

Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), an innovative company specializing
in the development of orphan oncology drugs, today provided an update on
financial results and major milestones achieved during the first quarter of
2016, ending March 31, 2016.

•Continued advancement of R&D programs:
◦Livatag® (doxorubicin nanoformulation in Phase III trial for treatment of
hepatocellular carcinoma):
■Eighth positive DSMB recommendation for the ReLive Phase III clinical trial
confirms safety profile
■New data on Livatag®’s unique mechanism of action presented at the AACR Annual
Meeting in New Orleans, LA, USA
◦Beleodaq®:
■Preclinical studies assessing the efficacy of Beleodaq® Livatag® in combination
with other oncology agents; initial data expected mid-2016.
◦Validive®:
■Strategic decision to pursue further development only through partnership,
following confirmation by the U.S. Food and Drug Administration of the clinical
development plan
•Expansion of Onxeo’s orphan oncology pipeline through acquisition of DNA
Therapeutics and lead compound based on signal-interfering technology:
◦AsiDNA, first-in-class signal-interfering DNA (siDNA) molecule which
accelerates cancer cell death by breaking the cycle of tumor DNA repair:
■Technology at the forefront of scientific research for cancers with significant
unmet medical needs
■Potential to generate substantial shareholder value through new orphan oncology
opportunities
■€1.7 million cash-free acquisition closed March 25, 2016, concurrent with €1
million investment in Onxeo by former DNA Therapeutics shareholders via private
placement. Additional milestone payments are expected once the product reaches
the market.
•Establishment of New York City-based U.S. subsidiary:
◦Direct U.S. presence will enable expansion of the Company’s development
programs and establishment of closer ties with the scientific and financial
communities in this key market
◦Philippe Maitre, pharmaceutical and biotech industry veteran, appointed
Executive VP & Chief of U.S. Operations
•Enhancement of the Company’s Board of Directors with the election as Chairman
of Joseph Zakrezwski, a top personality in the biotech and pharmaceutical
industry, and the appointments of international oncology R&D experts Prof. Jean
-Pierre Kinet, M.D. and Jean-Pierre Bizzari, M.D.
Judith Greciet, CEO of Onxeo, commented, “In the first quarter of 2016, we built
upon our momentum and reinforced our position as an emerging leader in the
development of orphan oncology therapeutics. We advanced the development of our
lead asset, Livatag®. We are approaching near-term completion of Phase III
recruitment, leading to reporting preliminary results mid-2017. The quarter was
also highlighted by our acquisition of DNA Therapeutics and its siDNA technology
platform, which we believe has the potential to change the paradigm of cancer
care while greatly enhancing our ability to develop innovative therapies for
patients in need. The DNA Therapeutics acquisition comes less than two years
after the merger between BioAlliance Pharma and Topotarget that created Onxeo,
and demonstrates our commitment to maximizing the opportunities to grow in the
orphan oncology space. We are building a robust portfolio of commercialized
products and highly promising product candidates. Collectively, these assets
form a strong foundation upon which to grow the Company”.

Q1 financial information

Revenues for the first quarter of 2016 totaled €782K, compared with €918K in the
first quarter of 2015, impacted by a decrease in non-recurring revenues, from
€157K in the first quarter of 2015 to €27K in the first quarter of 2016. This is
primarily due to the accounting impact of IFRS relating to recognition of
upfront payments on certain licensing agreements.

First quarter 2016 recurring revenues, which relate to product sales to
commercial partners and royalties on product sales by Onxeo’s partners, were
roughly flat compared to Q1 2015 (€755K compared with €761K in the first quarter
of 2015). After the period of integration of Innocutis’ products and teams by
Cipher mid-2015, revenues originating from Sitavig® are back with a positive
trend, resulting notably from an increase in price. Spectrum Pharmaceuticals
maintained active marketing efforts to drive the growth of Beleodaq® in the
highly competitive second-line PTCL market.

As of March 31, 2016, consolidated cash position amounted to €24.4 million, in
line with expectations. This figure does not include the €1 million capital
increase linked with the acquisition of DNA Therapeutics, which was received
subsequent to the end of the first quarter.

“Taking into account the planned reimbursement of the 2015 R&D tax credit of
€3.8 million, our current cash position is sufficient to fund development into
the second half of 2017, as per our plans, allowing us to deliver on important
milestones over that time”, concluded Nicolas Fellmann, CFO of Onxeo.

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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);
and in combination with other cancer agents in first-line HCC
•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 other cancer
agents is currently in development in first-line treatment for patients with
PTCL (BelCHOP) and in other solid tumors
•AsiDNA : the first-in-class siDNA (signal interfering DNA) which has
successfully undergone a proof-of-concept Phase I/IIa trial in metastatic
melanoma
•Validive® (Clonidine Lauriad®): Positive final results from a Phase II trial in
head and neck cancer patients with severe oral mucositis;
Learn more by visiting www.onxeo.com.

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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 14, 2015, which is available on the AMF
website (http://www.amf-france.org) or on the company’s website (www.onxeo.com).
Contacts
Nathalie Delair-Trepo, + 33 1 45 58 76 00
Investor Relations, Onxeo
investors@onxeo.com
or
Caroline Carmagnol /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