Onxeo: Q1 2017 Financial Information and Business Update

  • Revenues up 55% to €1.2 million
  • Cash position of €21.7 million at March 31, 2017
  • All strategic assets are progressing according to development plans

PARIS--()--Regulatory News:

Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), a biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, today announces its consolidated revenues and cash position at March 31, 2017 and issues a business update.

Judith Greciet, Chief Executive Officer of Onxeo, says: “Our achievements over the first quarter of 2017 are perfectly aligned with our strategy that aims to position Onxeo as a major reference in orphan oncology diseases. We are particularly pleased to have been able to finalize enrollment in the ReLive phase III study of Livatag® in January, in line with our goal to obtain preliminary clinical results around mid-year. Besides, we have made significant progress in our efforts to develop our other two strategic assets, Beleodaq® administered orally and AsiDNA™, which should enable the initiation of phase I clinical trials on these two promising compounds by the end of 2017. All indicators are positive at the end of the first quarter and in line with our business plan.

Financial information for the 1st quarter of 2017

Revenues increased by 55% to €1,211,000 in the first quarter of 2017 and consisted of:

  • €914,000 in recurring revenue resulting from the sale of products to ONXEO’s commercial partners and royalties on sales. This represents a 21% increase notably due to Beleodaq® sales in the United States by Spectrum Pharmaceuticals.
  • €297,000 in non-recurring revenue (compared with €27,000 in the first quarter of 2016), corresponding essentially to the phased IFRS recognition of the initial payment associated with the exclusive license agreement signed with Pint Pharma in 2016.

At March 31, 2017, the Company had a consolidated cash position of €21.7 million, excluding the €4 million reimbursement of 2016 Research Tax Credit expected in 2017. These resources give Onxeo financial visibility until the beginning of 2018.

Clinical or preclinical development of strategic assets in line with plans

  • Livatag®
    • Completion, in January 2017, of the enrollment and randomization of 390 patients for the phase III ReLive study to assess the efficacy of Livatag® in treating advanced hepatocellular carcinoma (HCC);
    • Top-line results / event-driven analysis expected by mid-2017.
  • AsiDNA™
    • Partnership signed with the Institut Curie in January 2017 to investigate the benefits of combining our first-in-class DNA repair inhibitors with radiotherapy and immunotherapy in the treatment of drug-resistant cancers;
    • Additional patent granted in February 2017 extending protection of AsiDNA™ in the USA;
    • Sound progress on the manufacturing process to obtain adequate product to further explore AsiDNA potential via an IV administration (preclinically and then clinically):
      • In vivo proof of concept of the effect of AsiDNA™ administered systemically (intravenously) expected at the end of the first half of 2017;
      • Launch by the end of 2017, of a phase I clinical study to show the safety/ efficacy of AsiDNA™ administered intravenously.
  • Beleodaq®
    • Preparatory work continuing with Spectrum Pharmaceuticals to assess the use of belinostat as a first-line treatment for Peripheral T-Cell Lymphoma (PTCL);
    • Managed access program in place in several European countries since earlier this week, thanks to an agreement with Clinigen;
    • Ongoing activities to develop an oral formulation in order to initiate a phase I/II clinical trial, at the end of 2017, either as monotherapy or in combination with other anti-cancer agents in other types of cancer.

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 cancers. Its growth strategy is founded on the development of innovative, effective, and safe drugs based on breakthrough technologies that can make a real difference in the treatment of orphan oncology diseases and considerably improve the quality of life of patients affected by rare or resistant cancers.

Onxeo’s comprehensive portfolio features a broad orphan oncology pipeline, with 3 major products in several on-going preclinical and clinical programs, alone or in combination for various cancer indications.

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

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 2016 Reference Document filed with the AMF on April 24, 2017, which is available on the AMF website (http://www.amf-france.org) or on the company’s website (www.onxeo.com).

Contacts

Onxeo
Valerie Leroy
Investor Relations
investors@onxeo.com
+33 1 45 58 76 00
or
Media Relations
Caroline Carmagnol / Simon Derbanne Alize RP
onxeo@alizerp.com
+33 6 64 18 99 59 / +33 6 38 16 26 41
or
Relations investisseurs / Communication stratégique
Dušan Orešanský / Emmanuel Huynh
NewCap
onxeo@newcap.eu
+33 1 44 71 94 92
or
Investor Relations US
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
+1 212 915 2578

Contacts

Onxeo
Valerie Leroy
Investor Relations
investors@onxeo.com
+33 1 45 58 76 00
or
Media Relations
Caroline Carmagnol / Simon Derbanne Alize RP
onxeo@alizerp.com
+33 6 64 18 99 59 / +33 6 38 16 26 41
or
Relations investisseurs / Communication stratégique
Dušan Orešanský / Emmanuel Huynh
NewCap
onxeo@newcap.eu
+33 1 44 71 94 92
or
Investor Relations US
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
+1 212 915 2578