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Onxeo

Report Publication Announcement Oct 12, 2016

1573_iss_2016-10-12_1df8abfc-ee39-4c29-ad19-2a4ae8a02930.pdf

Report Publication Announcement

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Publication of Shareholder Letter

Paris (France), Copenhagen (Denmark), October 12, 2016 – Onxeo S.A. (Euronext Paris, Nasdaq Copenhagen: ONXEO), an innovative company specialized in the development of orphan oncology therapeutics, today announced the publication of an Onxeo Shareholder Letter.

This Shareholder Letter provides an update on Onxeo's achievements in 2016 so far with a special focus on the newest addition to our pipeline, AsiDNATM.

The Shareholder Letter is available on the company's website www.onxeo.com in the section Media or Investors/Shareholders.

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 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. Onxeo's comprehensive portfolio features a broad orphan oncology pipeline, with four independent programs in various stages of clinical development, including Onxeo's first approved orphan oncology drug, Beleodaq®. 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's orphan oncology products 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 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; 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 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

In addition, Onxeo has successfully developed and registered two non-cancer products which are currently being commercialized in the U.S. and Europe.

Learn more by visiting www.onxeo.com.

To receive our press releases and newsletters, please register on: http://www.onxeo.com/en/newsletter/ Follow us on Twitter: @Onxeo_

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 2015 Reference Document filed with the AMF on April 29, 2016, which is available on the AMF website (http://www.amf-france.org) or on the company's website (www.onxeo.com).

Contact:

Judith Greciet, CEO Nicolas Fellmann, CFO [email protected] +33 1 45 58 76 00

Caroline Carmagnol / Florence Portejoie – Alize RP (France) [email protected] +33 6 64 18 99 59 / +33 6 47 38 90 04

Kirsten Thomas / Lee Roth – The Ruth Group (U.S.) [email protected] / [email protected] +1 508 280 6592 / +1 646 536 7012

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