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Onxeo

Regulatory Filings Oct 17, 2019

1573_iss_2019-10-17_1c18498b-8704-45f7-ac5c-c6f35885d44c.pdf

Regulatory Filings

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PRESS RELEASE

Onxeo, Winner of the Innov'up Leader PIA Call for Projects, Receives Funding of €495,000

  • The winning project aims to develop a drug candidate in immuno-oncology from the platON™ platform
  • Funding from the French State and the Île-de-France Region, operated by Bpifrance, consists of a grant of €330,000 and a repayable advance of €165,000

Paris (France), October 17, 2019 – 6:30 pm 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 targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, today announced that the Company has signed a collaboration agreement with the French State and the Île-de-France Region as part of the Innov'up Leader program PIA (Program of Investments for the Future) with funding of €495,000.

The programme, funded in equal amounts by the State and the Region, aims to accelerate the emergence of future leaders in their market who can claim international scope and are the driving force of disruptive innovation projects.

The winning project of Onxeo involves the development of a drug candidate targeting new therapeutic targets in immuno-oncology. Derived from the platON™ platform, it will be based on the principle of a decoy agonist oligonucleotide, as AsiDNA™ is. The sum of €495,000, granted by public partners to the cofinancing, represents 50% of the total amount of the project and consists of a grant of €330,000 and a repayable advance of €165,000. It is paid in two instalments, with a first payment upon signing of the contract.

"We are very pleased with this funding, which will allow us to accelerate the expansion of our pipeline of drug candidates. With this project, we capitalize on our expertise in the field of DDR and decoyoligonucleotide drugs, while targeting the very attractive and booming field of immuno-oncology." stated Judith Greciet, Chief Executive Officer of Onxeo.

About the Innov'up Leader PIA Progam

Innov'Up LEADER PIA, operated by Bpifrance, is a call for projects launched by the State and the Île-de-France Region to support innovation in 7 strategic sectors in the Paris region.

Upcoming events

October 23-24, 2019 Conférence Galien MedStart'Up New York, NJ, USA
October 26-30 2019 Conférence 'Molecular Targets & Cancer Therapeutics'
de l'AACR-NCI-EORTC
Boston, MA, USA
November 6, 2019 Évènement Direct Dirigeants Paris, France
November 12-13, 2019 Bryan, Garnier & Co European Healthcare Conference Paris, France
November 12-15, 2019 Tides Europe 2019 Amsterdam, Holland
January 29-31, 2020 DNA Damage Response Therapeutics Summit 2019 Boston, MA, USA

About Onxeo

Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a clinical-stage biotechnology company developing innovative oncology drugs targeting tumor DNA-binding functions through unique mechanisms of action in the sought-after field of DNA Damage Response (DDR). The Company is focused on bringing early-stage first-in-class or disruptive compounds from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners.

platON™ is Onxeo's proprietary chemistry platform of oligonucleotides acting as decoy agonists, which generates new innovative compounds and broaden the Company's product pipeline.

AsiDNA™, the first compound from platON™, is a first-in-class, highly differentiated DNA Damage Response (DDR) inhibitor based on a decoy and agonist mechanism acting upstream of multiple DDR pathways. Translational research has highlighted the distinctive properties of AsiDNA™, notably its ability to abrogate tumor resistance to PARP inhibitors regardless of the genetic mutation status. AsiDNA™ has also shown a strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors. The DRIIV-1 (DNA Repair Inhibitor-administered IntraVenously) phase I study has evaluated AsiDNA™ by systemic administration (IV) in advanced solid tumors and confirmed the active doses as well as a favorable human safety profile. The ongoing DRIIV-1b extension study is assessing the safety and efficacy of a 600 mg dose of AsiDNA™ in combination with carboplatin and then with carboplatin and paclitaxel, in patients with solid tumors who are eligible for such treatments.

OX401 is a new drug candidate from platON™, optimized to be a next-generation PARP inhibitor acting on both the DNA Damage Response and the activation of immune response, without inducing resistance. OX401 is undergoing preclinical proof-of-concept studies, alone and in combination with immunotherapies.

Onxeo's portfolio also includes belinostat, an HDAC inhibitor (epigenetics). Belinostat is already conditionally FDA-approved in the US as a 2nd line treatment for patients with peripheral T cell lymphoma and marketed in the US under the name Beleodaq® (belinostat IV form).

For further information, please visit 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 5.7.1.4 "Risk Factors" ("Facteurs de Risque") of the 2018 registration document filed with the Autorité des marchés financiers on April 25, 2019 under number D.19-0282, which is available on the Autorité des marchés financiers website (www.amf-france.org) or on the Company's website (www.onxeo.com).

Contacts

Onxeo Valerie Leroy, Investor Relations [email protected] +33 1 45 58 76 00

Media Relations Nicolas Merigeau NewCap [email protected] +33 1 44 71 94 98

Investor Relations / Strategic Communication Dušan Orešanský / Emmanuel Huynh NewCap [email protected]

+33 1 44 71 94 92

COMMUNIQUÉ DE PRESSE

Investor Relations US Brian Ritchie LifeSci Advisors [email protected] +1 212 915 2578

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