Onxeo

Regulatory Filings • Oct 19, 2015

Onxeo Validive® Abstract Accepted for Oral Presentation at ASTRO Annual Meeting 2015

Paris (France), Copenhagen (Denmark), October 19, 2015 – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced that an abstract supporting the clinical evaluation of Validive® (Clonidine Lauriad®), a mucoadhesive buccal tablet developed for the prevention and treatment of chemo-radioation therapyinduced severe oral mucositis (SOM) in patients with head and neck cancer, has been accepted for oral presentation at the upcoming 57th American Society for Radiation Oncology (ASTRO) Annual Meeting, being held October 18-21, 2015 in San Antonio, TX.

In an oral presentation during the ePoster 16 Discussion Session "Head and Neck V" on Wednesday, October 21, Dr. Jordi Giralt, M.D., Ph.D., Head of the Radiation Oncology Service at Vall d'Hebron University Hospital in Barcelona, Spain, and investigator of the Validive® Phase 2 trial, will discuss compliance and patient acceptability of Validive® findings from the global Phase 2 randomized doubleblind, placebo-controlled study.

Logistical details for the oral presentation and poster session include:

Title: Compliance and Patient Acceptability of Clonidine Mucoadhesive Buccal Tablet (Clonidine Lauriad) to Prevent Severe Radiomucositis in Head and Neck Cancer Patients

Presenting Author:	Jordi Giralt, M.D., Ph.D. Head of the Radiation Oncology Service at Vall d'Hebron University Hospital, Barcelona, Spain
Oral ePoster 16 Discussion:	Head and Neck V
	Presentation # 1139
	Wednesday, October 21, 2015
	10:45 a.m. – 12:15 p.m. CT
	Room 102 A/B, Henry B. Gonzalez Convention Center

About Validive® (Clonidine Lauriad® )

Validive® is a therapeutic application of clonidine based on the mucoadhesive technology Lauriad®. Onxeo's proprietary Lauriad® technology significantly increases the mucous and salivary concentrations of the active ingredient it contains, with decreased systemic absorption.

As an agonist of the alpha-2 adrenergic receptors, Validive® exhibits anti-inflammatory properties, and was developed for the prevention and treatment of chemoradioation therapy-induced severe oral mucositis in patients with head and neck cancer. Preclinical studies and a Phase II trial have confirmed Validive's mechanism of action and demonstrated that the therapy significantly reduces incidence of severe mucositis, improves oral mucositis-related symptoms and decreases radiotherapy-related adverse events, and exhibits a favorable safety profile and strong adherence to treatment. Based on these results, the trial Advisory Board approved a Phase III trial, which Onxeo plans to initiate by end 2015

Validive® was granted orphan drug status in Europe in November 2011 and also received Fast-Track status from the U.S. Food and Drug Administration (FDA) in January 2014.

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 US in 2nd line treatment of peripheral T-cell lymphoma For more information, visit the website www.onxeo.com

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 :

Judith Greciet, CEO j.greciet@onxeo.com Nicolas Fellmann, CFO n.fellmann@onxeo.com +33 1 45 58 76 00

Caroline Carmagnol / Florence Portejoie – Alize RP (France) onxeo@alizerp.com +33 6 64 18 99 59 / +33 1 44 54 36 64

Kirsten Thomas / Lee Roth – The Ruth Group (U.S.) kthomas@theruthgroup.com / lroth@theruthgroup.com +1 508 280 6592 / +1 646 536 7012