Onxeo Announces Establishment of U.S. Subsidiary

Regulatory News:

Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), an innovative company specializing in the development of orphan oncology therapeutics, today announced the creation of a U.S. subsidiary, based in New York City. The company also announced that experienced industry executive Philippe Maitre will head the U.S. subsidiary with the title of Executive VP & Chief of U.S. Operations. The U.S. subsidiary, to be named Onxeo US, will provide services to Onxeo as the company expands its development programs and establishes closer ties with the scientific and financial communities in the U.S.

Judith Greciet, CEO of Onxeo, commented: "The opening of a U.S. subsidiary, to be based in the key business, financial and medical hub of New York City, is a significant step and an important strategic initiative aimed at achieving our goal of connecting with more patients, physicians, Pharma and Biotech companies and investors in the United States. Having a dedicated and experienced team there will allow us to adapt our future activities to the needs of the largest healthcare market in the world. We are delighted to welcome Philippe Maitre to our team as the head of our U.S. subsidiary. Philippe is a seasoned biotech and pharmaceutical professional with experience leading several U.S. companies, with particular expertise in finance, business development and mergers and acquisitions. Philippe brings a wealth of valuable industry experience to Onxeo, and will be responsible for establishing the US subsidiary and assisting with a series of strategic initiatives to serve Onxeo’s growth. We look forward to working closely with him to achieve our global objectives.”

Philippe Maitre commented: "It is a privilege to join Onxeo and to work with such a highly qualified team. Through compelling technologies and a strong product pipeline targeting orphan diseases, including the recent acquisition of DNA Therapeutics, there is significant potential to capitalize on numerous research and business opportunities in the U.S. I look forward to leading the U.S. operations and providing the input needed to advance the strategic development of the Company.”

Mr. Maitre brings more than 35 years of experience in the pharmaceutical and biotech industry, including nearly 15 years as Corporate Officer for US public companies. Mr. Maitre has served as Chief Executive Officer and Co-Founder of mAbRx, a biotech company developing monoclonal antibodies against cancer stem cells in partnership with the Duke Cancer Center. Prior to founding mAbRx, Philippe has been the Chief Executive Officer at Anosys, a cancer vaccine company spin-off from Aventis (today Sanofi). He has also served as a Chief Financial Officer for NASDAQ-listed companies Pharmaceutical Product Development Inc. (PPD Inc.) and Oscient Pharmaceuticals. Earlier in his career, Mr. Maitre served in various roles such as finance, business development and investor relations at companies Rhone Poulenc, Rhone Poulenc Rorer as well as Aventis, where he ultimately held the position of Senior Partner and Deputy CFO for Aventis Pharma Group.

Prior to joining the Pharma Industry, Mr. Maitre served in the French Ministry of Foreign Affairs where he was stationed in Libya. He earned his master's in Finance from the Hautes Etudes de Commerce (HEC) Business School in Paris.

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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