Onxeo Poster Demonstrating Unique Livatag® Mechanism of Action Accepted for Presentation at AACR Annual Meeting

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 therapeutics, today announced that a poster demonstrating the unique mechanism of action of Livatag® has been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting, one of the most prestigious meetings on preclinical research in the field of oncology, being held April 16-20, 2016 in New Orleans, LA, USA.

Preclinical studies were conducted in relevant models to evaluate the mechanism of action of doxorubicin loaded nanoparticle formulation (Livatag®) in comparison with free doxorubicin in overcoming hepatocellular carcinoma (HCC) cellular resistance.

The complete data, and their implication on the role of nanoparticles in the treatment of HCC will be discussed at AACR during the poster session by Dr. Graham Dixon, PhD, Chief Scientific Officer at Onxeo.

Livatag®’s nanoformulation is designed to accumulate doxorubicin in the liver and evade tumor cell resistance mediated by multiple drug resistance (MDR) efflux pumps. The efficacy of Livatag® is currently being evaluated in a Phase 3 trial (ReLive study) compared to Best Standard of Care (BSC) in patients with advanced HCC.

Logistical details of the poster are as follows:

Abstract #2143 / Poster #13: Mechanistic study of the relative cytotoxicity of doxorubicin loaded nanoparticle formulation compared to free doxorubicin in hepatocellular carcinoma (HCC) cell lines

Date: Monday, April 18, 2016
Time: 1:00 – 5:00 p.m. EDT
Location: Section 18

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
• Validive® (Clonidine Lauriad®): Positive final results from a Phase II trial in head and neck cancer patients with severe oral mucositis;

In addition, Onxeo recently reached an agreement to acquire DNA Therapeutics, a privately-held, clinical-stage biopharmaceutical company, for its first-in-class, signal-interfering DNA (siDNA) repair technology, which is directed at overcoming cancer resistance mechanisms. The transaction is expected to close by the end of March 2016.

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).

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