Paris (France), June 19, 2017 – 17 :45 CEST – Onxeo SA (Euronext Paris, Nasdaq Copenhagen: ONXEO), (” Onxeo “or the” Company “), a biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, especially in oncology, today announced the launch of a capital increase to certain institutional investors in France and abroad.
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The funds raised will be allocated to the development of its R&D programs in the field of pathologies of orphan oncology as well as more generally to the financing of the activity of the Company.
Onxeo has three strategic assets, including the development steps are the following :
Livatag®, a nanoformulation of doxorubicin (doxorubicin TransdrugTM) undergoing evaluation in a phase 3 for the treatment of hepatocellular carcinoma ; the first analysis of the results of this trial, a phase 3, ReLive, is expected before the end of September 2017.
Beleodaq®, a HDAC inhibitor marketed in the United States in the treatment of lymphoma T cell peripheral (PTCL) ; a program of preclinical study exploratory in other indications continues, the first results are expected at the end of the third quarter of 2017.
AsiDNA, a product of first-in-class*, which prevents the repair of DNA tumor ; the first clinical results systemically (IV) are provided during the summer which would allow to initiate a phase 1 study in end-of-year.
The gross proceeds of the transaction is expected to amount to approximately 12 MILLION. The Company has announced a consolidated cash of 21.7 M at the end of the first quarter of 2017 and the present operation is intended to extend the financial visibility of Onxeo up in the 4th quarter of 2018. The Company also intends to pursue a strategy of optimizing its portfolio, which could result in a non-dilutive financing, including the monetization of its non-strategic assets. The raising of funds considered would result in the issuance of approximately 3,000,000 shares, representing approximately 6.4% of the share capital of the Company on a non-diluted basis.
The fundraising will be carried out via a capital increase with cancellation of the preferential subscription right of the existing shareholders of the Company, in accordance with the eighteenth and twentieth resolutions of the extraordinary general meeting of the Company dated may 24, 2017 and on the basis of articles L. 225-136 of the French commercial code and L. 411-2(II) of the French monetary and financial code.
The fundraiser will take place through an accelerated bookbuilding of orders, commencing immediately and which should be settled before markets open tomorrow, subject to any early closing or extension. The Company will announce the result of the fundraising as soon as possible after the closing of the order book in a press release later. The settlement-delivery of new shares and their admission is scheduled for 22 June 2017 on the regulated market of Euronext Paris, and as soon as possible on the regulated market of the Nasdaq OMX stock exchange in Copenhagen (Denmark).
The raising of funds by accelerated building of an order book is open to institutional investors in France, in each of the member States of the european economic Area in accordance with the derogations provided by article 3(2) of the directive 2003/71/EC of the european Parliament and of the Council of 4 November 2003 (as amended) to the extent they have been transposed in this member State or, in the contrary case, in situations that do not require the publication of a prospectus pursuant to article 3(2) cited above and/or regulations applicable in that member State, and outside of the United States of America pursuant to Regulation S of the U.s. Securities Act of 1933, as amended (the ” Securities Act “). Simultaneously, the Company realized a private placement in the United States of America to “qualified institutionnal buyers” as defined under Rule 144A of the Securities Act or institutional ‘accredited investors’ ” as defined by Rule 501(a) of the act.
The fund-raising does not give rise to a prospectus submitted to the visa of the Autorité des marchés financiers.
Public attention is drawn to the risk factors relating to the Company and its business activity, as presented in section 5.5.1.4 of the reference document 2016 filed with the Autorité des marchés financiers on April 24, 2017, under number D. 17-0423, available free of charge on the internet sites of the Company (www.onxeo.com) and/or of the Autorité des marchés financiers (www.amf-france.org).
In conjunction with the determination of the definitive terms and conditions of the capital increase, the Company will sign a commitment to conservation for a period of 90 days after the date of pricing of the capital increase, subject to the usual exceptions. Persons acting on behalf of the Company (that is to say, the members of the executive committee or directors) will also sign similar commitments in respect of the shares of the Company they hold.
Guggenheim Securities, LLC and Oddo BHF act as Levels of Book Associated.
This press release does not constitute a prospectus under the Prospectus directive or an offer to the public.
About Onxeo
Onxeo is a company of biotechnology with the clinical stage, specializing in the development of innovative medicines for the treatment of orphan diseases in particular in the field of oncology, in response to a strong demand therapy in one of the segments with the strongest growth of the pharmaceutical industry.
Onxeo has the ambition of becoming a global leader and a pioneer in the field of cancer is an orphan, or rare. The strategy of Onxeo is based on the development of therapies for advanced, effective and safe, designed to improve the lives of patients with rare cancers or resistant to making a true difference compared to current therapies.
The portfolio of Onxeo in cancers orphans includes 3 major products in a number of programs in preclinical and clinical courses, alone or in combination for multiple cancer indications :
Livatag® (Doxorubicin Transdrug) : Currently under evaluation in the framework of the Phase III trial ReLive in patients with hepatocellular carcinoma (primary liver cancer or HCC) ; ReLive aims to demonstrate the effectiveness and the tolerance of Livatag® in comparison to the best available treatment chosen by the doctor in 390 patients with hepatocellular carcinoma (hcc (advanced HCC, also called primary liver cancer) after failure or intolerance to sorafenib
Beleodaq® (belinostat) : Approved subject to conditions in the United States in 2014 by the u.s. Food and Drug Administration (FDA), in the framework of an accelerated procedure for authorising the placing on the market, in the 2nd-line treatment for patients with T-cell lymphoma peripheral (PTCL) and is currently marketed by Spectrum Pharmaceuticals ; the combination of belinostat with other anticancer agents is currently being evaluated in the treatment of 1st-line patients with PTCL (study BelCHOP) and for solid tumours ;
AsiDNA : first product of a new class of drugs derived from the technology sedna (signal interfering DNA), of which a first Phase I study in metastatic melanoma has allowed to establish the proof-of-concept ; the Company is committed to a programme preclinical to demonstrate the effectiveness of AsiDNA systemically.
The Company is based in Paris, France, with offices in Copenhagen and New York, and has approximately 60 employees. Onxeo is listed on Euronext Paris, France and on the Nasdaq Copenhagen, Denmark (Mnémo : ONXEO, ISIN Code : FR0010095596).
For more information : www.onxeo.com
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