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  Press Release  
 
 
 
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, OR JAPAN
 
This announcement is not an offer to sell, or a solicitation of an offer to acquire any securities. Investors should not purchase any securities referred to in this announcement except on the basis of information in the prospectus to be published by Bone Therapeutics SA in due course (when approved by the Belgian Financial Services and Market Authority (FSMA) and passported by the French Autorité des Marchés Financiers (AMF) and which can then be obtained on www.bonetherapeutics.com) in connection with the offering and admission to listing of its shares on Euronext Brussels and Euronext Paris.
 
Bone Therapeutics Announces Intention to Launch an Initial Public Offering on Euronext Brussels and Euronext Paris
 
Gosselies, Belgium, 16 January 2015 - BONE THERAPEUTICS, the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, announces today its intention to raise new funds through an Initial Public Offering on Euronext Brussels and Euronext Paris.

Highlights
  • Bone Therapeutics is a leader in bone cell therapy
  • Since it was founded in 2006, the Company has already achieved clinical proof-of-concept and built a broad and clinically advanced pipeline (2 pivotal Phase III and 3 Phase II) to address specifically the bone fracture repair market (severe unhealed fractures) and the bone fracture prevention market (bone fragility conditions)
  • Through a unique treatment approach using differentiated bone-forming cells, Bone Therapeutics’ products, administered via a minimally invasive procedure, form new bone and regenerate a healthy bone environment
  • This approach is expected to offer significant benefits over the current costly standard-of-care that often involves invasive surgery at high risk of complications and long recovery periods
  • The Company has two complementary, first-in-class product platforms, the autologous PREOB® and the allogeneic ALLOB®, targeting five indications and protected by nine families of patents:
    • Two pivotal Phase III clinical trials in non-union fractures and osteonecrosis
    • Three Phase II clinical trials in delayed-union fractures, osteoporosis and spine fusion
  • The relevant fracture repair and fracture prevention markets (including the osteoporosis market) represent a global market of around USD 34 billion and 42 million patients[1]. The Company’s products target about a third of these markets, representing approximately 12 million patients in Europe, the US and Japan, with limited competition.
  • The Company has a certified GMP production facility in Brussels and plans to move to a new larger scale state-of-the-art GMP facility by mid-2016 
Commenting on today’s announcement, Enrico Bastianelli, CEO of Bone Therapeutics, said: “Bone Therapeutics is developing a leading and innovative breakthrough technology in bone cell therapy. Our products, composed of differentiated bone cells enabling bone regeneration, bring a new treatment paradigm to the field of fracture repair and fracture prevention. Results gathered so far have been very positive and address areas of high unmet medical need with limited competition. To pursue ongoing clinical development and consider product commercialisation, we believe that this is the ideal time to apply for a listing of the Company’s shares on Euronext Brussels and Euronext Paris.”
 
Subject to the approval of the prospectus by the FSMA and market conditions, it is expected that the price range, as well as other details of the offering will be published in the Belgian and French financial press, when the offering period is expected to commence.
 
The Company’s strategy is to:
  • Accelerate pivotal Phase III trials and advance towards market authorization
  • Finalize promising Phase II trials
  • Launch clinical trials in the US
  • Leverage its bone cell differentiation platform and progress the preclinical pipeline
  • Scale-up of manufacturing capabilities
  • Build development and commercial partnerships
Key success factors
  • A leader in bone cell therapy with a unique breakthrough technology
  • An optimized approach
    • Strong clinical proof-of-concepts
    • Favourable Phase III trial designs
    • Broad pipeline with 5 indications
  • A sound strategy in fracture repair and prevention
  • An experienced management team backed by a high level scientific committee 
Bryan, Garnier & Co will act as Global Coordinator, and Kepler Cheuvreux and Bank Degroof will act as joint lead managers and Joint Bookrunners.

[1] Orthoworld, The Orthopaedic Industry Annual Report for 2013 (relating to fracture repair procedures and spine procedures) – Transparency Market Research, Osteoporosis Drugs Market – Global Industry Analysis, Pipeline Analysis, Size, Share, Growth, Trends & Forecast, 2014-2020 (relating to treatment of osteoporosis patients).
 
-Ends-
 
 
 
 
 

 
 

 
 

For further information, please contact:

Bone Therapeutics SA

Tel: +32 (0)2 529 59 90
Enrico Bastianelli, Chief Executive Officer
Wim Goemaere, Chief Financial Officer
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries
Consilium Strategic Communications

Amber Bielecka, Mary-Jane Elliott,
Jessica Hodgson and Lindsey Neville
Tel: +44 (0) 20 3709 5708
bonetherapeutics@consilium-comms.com
 

For French Media and Investor Enquiries
NewCap Investor Relations & Financial Communications


Pierre Laurent and Antoine Denry

Tel: +33 (0)1 44 71 94 94
adenry@newcap.fr

 
 

 
 
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About Bone Therapeutics

Bone Therapeutics is a leading biotechnology company specializing in the development of cell therapy products intended for bone fracture repair and fracture prevention. The current standard-of-care in this field involves major surgeries and long recovery periods. To overcome these problems, Bone Therapeutics is developing a range of innovative regenerative products containing osteoblastic/bone-forming cells, administrable via a minimally invasive percutaneous technique; a unique proposition in the market.
PREOB®, Bone Therapeutics’ autologous bone cell product, is currently in pivotal Phase IIb/III clinical studies for two indications: osteonecrosis and non-union fractures, and in Phase II for severe osteoporosis. ALLOB®, its allogeneic “off-the-shelf” bone cell product, is in Phase II for the treatment of delayed-union fractures and lumbar fusion for degenerative disease of the spine. The Company also runs preclinical research programs and develops novel product candidates.
Founded in 2006, Bone Therapeutics is headquartered in Gosselies (South of Brussels, Belgium). Bone Therapeutics’ regenerative products are manufactured to the highest GMP standards and are protected by a rich IP estate covering 9 patent families. Further information is available at www.bonetherapeutics.com
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This announcement does not constitute, or form part of, an offer or invitation to sell or issue, or any solicitation of an offer to purchase securities and any purchase of, or application for, shares in Bone Therapeutics to be sold in connection with the offering should only be made on the basis of information contained in the prospectus to be issued in due course in connection with the offering and any supplements thereto. The prospectus will contain certain detailed information about the Company and its business, management, risks associated with investing in the Company, as well as financial statements and other financial data.
 
Investing in the offered shares involves a high degree of risk. An investor is exposed to the risk of losing all or part of his/her investment. Before any investment in shares, the investor must read the risks, which will be described in the prospectus. The company's main assets are intellectual property rights concerning technologies that have not led yet to the commercialization of any product. The company has never been profitable.
 
These materials are not for distribution, directly or indirectly, in or into the United States. These materials do not constitute or form a part of any offer or solicitation to purchase securities in the United States. The securities mentioned herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended, (the “Securities Act”) and may not be offered or sold in the United States, except pursuant to an exemption from the registration requirements of the Securities Act. There will be no public offer of securities in the United States.
 
This communication is directed only at (i) persons who are outside the United Kingdom or (ii) persons who have professional experience in matters relating to investments falling within Article 19(1) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) and (iii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as “relevant persons”). Any investment activity to which this communication relates will only be available to and will only be engaged in with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.
 
This communication may be distributed in a member state of the European Economic Area, with the exception of Belgium and France, which applies Directive 2000/71/EC (this Directive together with any implementing measures in any member state, the “Prospectus Directive”) only to those persons who are qualified investors for the purposes of the Prospectus Directive in such member state, and such other persons as this document may be addressed on legal grounds, and no person that is not a relevant person may act or rely on this document or any of its contents.
 
This announcement and the information contained herein are not for publication, distribution or release in, or into, the United States, Canada, Australia or Japan.
 
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
 
The date of listing on Euronext Brussels and Euronext Paris may be influenced by things such as market conditions. There is no guarantee that such listing will occur and you should not base your financial decisions on the Company’s intentions in relation to such listing at this stage. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing the entire amount invested. This announcement does not constitute a recommendation concerning the offering. The value of the shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the offering for the person concerned.


 
Bone Therapeutics S.A. • Rue Adrienne Bolland, 8 • 6041 Gosselies • Belgium (Europe) • Phone: +32 (0) 2 529 59 90 • Fax: +32 (0) 2 529 59 93 • www.bonetherapeutics.com