Onxeo

Report Publication Announcement • Sep 18, 2017

Onxeo to host a Conference Call today to comment on the main findings from ReLive Phase III Study of Livatag®

Paris (France), September 18, 2017 – 8:00 am CEST – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or the "Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, will host a conference call today for its shareholders at 3.00 pm CEST to comment on the main data from the ReLive Phase III Study of Livatag®.

This presentation will set out the main study data presented at the 11th Annual Conference of the International Liver Cancer Association in Seoul, South Korea (ILCA – 15-17 September 2017).

Conference call on September 18, 2017 at 3.00 pm CEST

Dial: +33 (0)1 72 00 15 10

Participant code: 92479704#

The call will be held in French

Speakers will include Judith Greciet, CEO of Onxeo, and Olivier de Beaumont, CMO.

The presentation will be available on the Company website, www.onxeo.com, in the Products section, prior to the call.

About Hepatocellular Carcinoma, an aggressive form of primary liver cancer

Hepatocellular carcinoma (HCC) or hepatocarcinoma is the most common of the primary liver cancers (85% to 90%). According to Globocan (2012 data), liver cancer is the 6th most common cancer in terms of incidence (782,000 new cases worldwide each year, 5.6% of all new cancer cases) with the 2nd highest mortality rate (95% lethality) after lung cancer. The major risk factors are infection by hepatitis viruses (B and C), overconsumption of alcohol and metabolic diseases, especially non-alcoholic steatohepatitis (NASH), a growing cause of cirrhosis and HCC.

About ReLive Phase III trial

This international, multicenter, randomized, comparative Phase 3 trial was conducted in 11 countries (Europe, USA, and MENA) at 70 centers and enrolled 397 adult patients with unresectable hepatocellular carcinoma (HCC), intolerant to sorafenib or having progressed after a systemic therapy including sorafenib. Patients were randomized to receive Livatag® administered intravenously for 6 hours every 4 weeks (n=263) or best standard of care, i.e. any cancer therapy chosen by the physician except sorafenib (n=134). Treatment was continued until disease progression or unacceptable toxicity. The monitoring of the patients enrolled in the study will continue to completion, expected Q1 2019.

About Onxeo

Onxeo is a biotechnology company developing innovative drugs for the treatment of orphan diseases in oncology, driven by high therapeutic demand in one of the fastest growing segments of the pharmaceutical industry.

Onxeo's objective is to become a major international player in the field of rare or resistant cancers. Its growth strategy is to develop innovative, effective, and safe drugs based on breakthrough technologies that can make a real difference in patients' lives, by acquiring or in-licensing first-in-class or unique compounds at an early stage and bringing them through translational research and proof of concept clinical development up to value-creating inflexion points.

Onxeo's orphan oncology pipeline comprises products in several on-going preclinical and clinical programs, alone or in combination for various cancer indications.

• Livatag® is a nanoparticle formulation of the chemotherapy doxorubicin, developed using Onxeo's proprietary Transdrug™ technology designed to facilitate the penetration of the drug into the tumor cell and increase the target DNA exposure to the drug, thereby bypassing the mechanisms of multi-drug resistance developed by tumor cells.
• Beleodaq® (belinostat): a HDAC inhibitor, conditionally FDA-approved in the US 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 US, Spectrum Pharmaceuticals; Onxeo is currently developing an oral formulation of belinostat, to facilitate its use in combination and extend its IP protection ; belinostat in combination with other anti-cancer agents is also in ongoing development in other liquid or solid tumors, with the filing a phase 1 expected by the end of 2017.
• AsiDNA™: a first-in-class siDNA (signal-interfering DNA) candidate which has successfully undergone a proof-of-concept Phase I trial with a local administration in metastatic melanoma. Recent positive preclinical proof-of-concept results confirmed AsiDNA™ activity via systemic administration in a murine model of triple negative breast cancer (TNBC). The Company now plans to prepare a phase I trial via systemic administration by the end of 2017.

The Company is headquartered in Paris, France with offices in Copenhagen and in New York, and has approximately 60 employees. Onxeo is listed on Euronext in Paris, France and Nasdaq Copenhagen, Denmark (Ticker: ONXEO, ISIN Code: FR0010095596).

Learn more by visiting www.onxeo.com

Forward looking statements

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 section 5.5.1.4 "Risk Factors" ("Facteurs de Risque") of the 2016 reference document filed with the Autorité des marchés financiers on April 24, 2017 under number D.17-0423, which is available on the Autorité des marchés financiers website (www.amf-france.org) or on the Company's website (www.onxeo.com).

Onxeo

Valerie Leroy, Investor Relations investors@onxeo.com +33 1 45 58 76 00

Media Relations

Caroline Carmagnol / Alize RP alize-onxeo@alizerp.com +33 6 64 18 99 59

Investor Relations / Strategic Communication

Dušan Orešanský / Emmanuel Huynh NewCap onxeo@newcap.eu +33 1 44 71 94 92

Investor Relations US Brian Ritchie LifeSci Advisors britchie@lifesciadvisors.com +1 212 915 2578