Onxeo Launches Capital Increase

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PARIS & COPENHAGEN--(BUSINESS WIRE (http://www.businesswire.com/))-- Regulatory
News:

Onxeo S.A. (Euronext Paris, Nasdaq Copenhagen: ONXEO, “Onxeo” or ”the Company”),
a biopharmaceutical company specializing in the development of innovative drugs
for the treatment of orphan diseases, in particular in oncology, today announced
the launch of a capital increase of new ordinary shares without preferential
subscription rights reserved for the category of investors described below.

The Company intends to use the net proceeds from this capital increase to pursue
its R&D programs in the field of innovative therapeutics for rare cancers. More
specifically, the Company plans to finance:

  · The completion of Phase III ReLive trial for Livatag® as well as pre
-clinical studies in combination with this product,
  · The first stages of development of AsiDNATM, notably the manufacturing
process and evaluation of its efficacy using a systemic delivery route,
  · The future developments of Beleodaq® including first line PTCL indication,
and
  · Other working capital and general corporate purposes.

Key upcoming milestones of programs currently funded include:

  · Livatag®:
    · Preclinical combination plan
    · Next DSMB for the Phase III trial: Q4 2016
    · Preliminary results of the Phase III trial: expected mid-2017

  · Beleodaq®:
    · Preclinical combination study results: end of 2016 and onwards
    · 1st line PTCL Phase III initiation: end of 2016

  · AsiDNATM:
    · Phase I initiation (monotherapy systemic): expected in 2017

The capital increase will be carried out without shareholders’ preferential
subscription rights. Pursuant to Article L. 225-138 of the French Commercial
Code (Code de commerce), it will be reserved for a category of investors defined
in the 17th resolution of the General Shareholders' Meeting dated April 6, 2016,
i.e. sociétés et fonds d’investissement investissant à titre habituel dans des
sociétés de croissance dites « small caps » (c'est-à-dire dont la capitalisation
lorsqu’elles sont cotées n’excède pas 1 000 000 000 euros) (en ce compris, sans
limitation, tout FCPI, FCPR ou FIP) dans le secteur de la santé ou des
biotechnologies participant à l’augmentation de capital pour un montant unitaire
d’investissement supérieur à 100 000 euros (prime d’émission incluse), dans la
limite d’un maximum de 25 souscripteurs (i.e. companies and investment funds
that commonly invest in “small caps” (i.e. if listed, with a maximum market
capitalization of €1,000,000,000) (including, without limitation, any mutual
fund for investment, venture capital fund, or local investment fund) in the
health or biotechnology sector participating in the share capital increase for a
unit investment amount of over €100,000 (including issue premium), with a
maximum of 25 investors). A maximum of 12,165,624 new shares will be issued,
representing around 30% of the current share capital.

The issue price of new ordinary shares will have a maximum discount of 25% to
the volume weighted average share price of the Company’s shares listed on the
regulated market of Euronext Paris during the 3 last trading days preceding the
determination of the issue price.

Application will be made to list the new ordinary shares on the regulated market
of Euronext Paris and Nasdaq Copenhagen. A listing prospectus comprising the
2015 Reference Document (Document de Référence) of the Company registered with
the French Autorité des Marchés Financiers ("AMF") on April 29, 2016 under
number D.16-0452, the half-year financial report 2016 published by the Company
on July 28, 2016, and a Securities Note (Note d'Opération), including a summary
of the prospectus, will be submitted to the visa application with the AMF. The
attention of the public is drawn to the risk factors presented in section
5.5.1.4.1 of the 2015 Reference Document and section 2 of the Securities Note.

Simultaneously with the determination of the final terms and conditions of the
capital increase, the Company will enter into a lock-up agreement ending 90
calendar days after the date of the pricing of the offering, subject to certain
customary exceptions. All persons acting on behalf of the Company (i.e.
executives and/or directors) have also signed lock-up agreements with regard to
the Company's shares that they hold, for the same period.

Guggenheim Securities, LLC and Oddo & Cie are acting as Joint Bookrunners.

The final terms of the private placement will be announced as soon as
practicable.

This announcement does not constitute a prospectus within the meaning of the
Prospectus Directive or an offer to the public.

About Onxeo

Onxeo is a biopharmaceutical company specializing in the development of
innovative drugs for the treatment of orphan diseases, in particular 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 and aggressive cancers. 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
  · AsiDNATM: 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 (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%
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A%2F%2Fwww.onxeo.com&esheet=51430264&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=1&md5=cecacaa762f776b3a288c5578c3e63a5).

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Disclaimer

The distribution of this press release may be subject to legal or regulatory
restrictions in certain jurisdictions. Any person who comes into possession of
this press release must inform him or herself of and comply with any such
restrictions.

In France, the offer and sale of Onxeo SA shares described above will take place
solely through a placement for the benefit of a category of persons meeting
specific characteristics pursuant to Article L. 225-138 of the French Code
monétaire et financier and applicable regulations. The offer and sale do not
constitute a public offering in France, as defined in Article L. 411-1 of the
French Code monétaire et financier.

With respect to Member States of the European Economic Area that have transposed
European Directive 2003/71/EC of the European Parliament and European Council
(as amended in particular by Directive 2010/73/EU to the extent that the said
Directive has been transposed into each Member State of the European Economic
Area) (the “Prospectus Directive”), no action has been taken or will be taken to
permit a public offering of the securities referred to in this press release.
Therefore, such securities may not be and shall not be offered in any Member
State other than in accordance with the exemptions of Article 3(2) of the
Prospective Directive to the extent they have been transposed by the relevant
Member State or, otherwise, in cases not requiring the publication of a
prospectus under Article 3(2) of the Prospective Directive and/or the applicable
regulations in such Member State.

This press release and the information it contains are being distributed to and
are only intended for persons who are (i) outside the United Kingdom, (ii)
outside the United States, (iii) investment professionals falling within Article
19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order
2005 (the “Order”), (iv) high net worth entities and other such persons falling
within Article 49(2)(a) to (d) of the Order (“high net worth companies”,
“unincorporated associations”, etc.) or (v) other persons to whom an invitation
or inducement to engage in investment activity (within the meaning of Section 21
of the Financial Services and Market Act 2000) may otherwise lawfully be
communicated or caused to be communicated (all such persons in (i), (ii), (iii),
(iv) (v) together being referred to as “Relevant Persons”). Any invitation,
offer or agreement to subscribe, purchase or otherwise acquire securities to
which this press release relates will only be engaged with Relevant Persons. Any
person who is not a Relevant Person should not act or rely on this press release
or any of its contents.

This press release and the information it contains do not, and will not,
constitute an offer to subscribe for or sell, nor the solicitation of an offer
to subscribe for or buy, securities of Onxeo SA in the United States of America
or any other jurisdiction where restrictions may apply. Securities may not be
offered or sold in the United States of America absent registration or an
exemption from registration under the U.S. Securities Act of 1933, as amended
(the “U.S. Securities Act”), it being specified that the securities of Onxeo SA
have not been and will not be registered within the U.S. Securities Act. Onxeo
SA does not intend to register securities or conduct a public offering in the
United States of America.

In accordance with Article 211-3 of the General Regulation of the AMF, it is
recalled that:

  · the offer does not require a prospectus to be submitted for approval to the
AMF. However, a prospectus will be registered with the AMF in connection with
the admission to trading of the shares to be issued in connection with the
transaction.
  · persons or entities referred to in Point 2°, Section II of Article L. 411-2
of the Monetary and Financial Code may take part in the offer solely for their
own account, as provided in Articles D. 411-1, D. 411-2, D. 734-1, D. 744-1, D.
754-1 and D. 764-1 of the Monetary and Financial Code.
  · the financial instruments thus acquired cannot be distributed directly or
indirectly to the public otherwise than in accordance with Articles L. 411-1, L.
411-2, L. 412-1 and L. 621-8 to L. 621-8-3 of the Monetary and Financial Code.

Any decision to subscribe for or purchase the shares or other securities of
Onxeo SA must be made solely based on information publicly available about Onxeo
SA. Such information is not the responsibility of Guggenheim Securities, LLC and
Oddo & Cie and has not been independently verified by Guggenheim Securities, LLC
and Oddo & Cie.

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 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 (www.amf
-france.org (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww
. 
amf-france.org&esheet=51430264&newsitemid=0&lan=en-US&anchor=www.amf
-france.org&index=3&md5=de092167730ff9397e70719c4d6cb8da) ) or on the company’s
website
(www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2F
w 
ww.onxeo.com&esheet=51430264&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=4&md5=ea08aab0fe3dd1473ca2580a6aaf6b4e)).
Onxeo S.A.
Judith Greciet, CEO
Nicolas Fellmann, CFO
investors@onxeo.com
+33 1 45 58 76 00
or
Alize RP (France)
Caroline Carmagnol / Florence Portejoie
onxeo@alizerp.com
+33 6 64 18 99 59 / +33 6 47 38 90 04
or
The Ruth Group (U.S.)
Kirsten Thomas / Lee Roth
kthomas@theruthgroup.com / lroth@theruthgroup.com
+1 508 280 6592 / +1 646 536 7012