PARIS--(BUSINESS WIRE)--Regulatory News:
Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a biotechnology company specializing in the development of innovative drugs in oncology, and notably rare and resistant forms of cancer, today announced that it will record an impairment charge of about €38 million in its 2017 consolidated accounts pursuant to value tests performed in accordance with IFRS accounting standards. This accounting adjustment does not impact in any way the Company’s current or future cash balance or its ability to advance its strategic value creation strategy as planned.
During the process of the preparation of the consolidated accounts, the Group executed routine impairment tests of assets, notably intangible R&D assets pertaining to Beleodaq®, acquired in 2014 through the merger with Topotarget and valued €63 million. These tests were based on the comparison of the value of Beleodaq® recorded in the balance sheet and its fair value, based on discounted cumulative future cash flows during the 2018 – 2040 period. Following a review by the Company’s audit committee, the board of directors approved the recording of an impairment charge of about €38 million to the Company’s 2017 financial statements.
“This adjustment relates solely to the implementation of financial standards and has no impact on Onxeo’s cash position or operational performance,” said Nicolas Fellmann, Chief Financial Officer. “This impairment charge is related to an increased competitive environment for Beleodaq® in the peripheral T-cell lymphoma market. Importantly, the primary value driver for Onxeo for the foreseeable future is the continued development of AsiDNA™, a first-in-class DNA Damage Response inhibitor with blockbuster potential and our lead product candidate. We expect to initiate a phase I study of AsiDNA as an anti-cancer monotherapy in the coming weeks, with results anticipated to be available by year-end.”
Overall impairment test of the company showed a notable added value, when comparing the calculated fair value and the book value. This added value is mostly attributable to AsiDNA and reflects the progress made since acquisition in the development of this key asset, on which the company strongly relies to execute its growth strategy in the near future.
Onxeo will publish its 2017 full-year results on Thursday March 29, 2018.
Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a French biotechnology company developing innovative oncology drugs based on DNA-targeting and epigenetics, two of the most sought-after mechanisms of action in cancer treatment today. The Company is focused on bringing early-stage first-in-class or disruptive compounds (proprietary, acquired or in-licensed) from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners.
Onxeo’s R&D pipeline includes belinostat, an HDAC inhibitor (epigenetics) currently being developed in oral form to be used in combination with other anti-cancer agents for liquid or solid tumors. 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 by Onxeo’s partner, Spectrum Pharmaceuticals, under the name Beleodaq® (belinostat IV form).
Onxeo is also developing AsiDNA™, a first-in-class DNA break repair inhibitor based on a unique decoy mechanism. AsiDNA™ has already successfully completed a Phase I trial in metastatic melanoma via local administration, and is currently being developed for systemic (IV) administration in solid tumors.
AsiDNA™ is the first compound generated from platON™, the Company’s proprietary chemistry platform of decoy oligonucleotides based on three components, a sequence of double strand oligonucleotides, a linker and a cellular uptake facilitator. PlatON™ will continue to generate new compounds that will broaden Onxeo’s pipeline.
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 126.96.36.199 “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).