Écrit par BONE THERAPEUTICS | 17 Janvier 2015

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.

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