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  Press Release 29 March 2016  

Regulated information

Bone Therapeutics Reports Full Year 2015 Results

Dr Enrico Bastianelli, Chief Executive Officer and Wim Goemaere, Chief Financial Officer, will host a conference call today at 13:30 CEST / 12:30 BST / 07:30 EDT. The call will be conducted in English and a replay will be available for 7 days. To access the conference call, please dial one of the appropriate number below quoting the conference ID 72491662:

BE: +32 (0)80 04 08 64
FR: +33 (0)805 63 20 56
UK: +44 (0) 1452 555566
US: +1 (0)8669 669 439

The presentation will be made available on the Investors section of the Bone Therapeutics website shortly before the call ( To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled start timing.

Gosselies, Belgium, 29 March 2016 - BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair, fracture prevention and spinal fusion, today reports its full year results for the year ending 31 December 2015, prepared in accordance with IFRS as adopted by the European Union.

Key Highlights

  • Significant progress in ongoing clinical development, with positive safety and efficacy results from the ongoing Phase II trials
    • ALLOB® Phase I/IIA delayed-union trial: eight patients safely treated, with the first four patients achieving the primary efficacy endpoint
      PREOB® Phase IIA trial for severe osteoporosis: demonstration of safety of intravenous administration of PREOB® and successful migration of the cells towards the bones most prone to osteoporosis-related fractures
  • Initiation of a pioneering Phase IIA trial for the minimally invasive treatment of failed spinal fusions with ALLOB®
  • Orphan Drug Designation granted to ALLOB® by the EMA and FDA for the treatment of osteogenesis imperfecta or brittle bone disease
  • Successful € 37 million IPO on Euronext Brussels and Euronext Paris
  • Creation of a US subsidiary in Boston and opening of new headquarters in Gosselies, Belgium
  • Strengthening of the management team through the appointment of Thomas Lienard as Chief Business Officer
  • Granted € 5 million in new funding from the Walloon Region to support the Company’s preclinical research
  • Ended 2015 with € 33.61 million in cash, well in line with company expectations

Post-period highlights

  • Extension of the delayed-union program for ALLOB® into multiple delayed-union fractures
  • ALLOB® Phase IIA spinal fusion trial: 75% of patients now treated, with successful fusion demonstrated in the first patient
  • Positive efficacy results from the PREOB® Phase IIA trial in severe osteoporosis after the 12-month follow-up of the first cohort of patients in the study, showing that a single administration of PREOB® had sustained beneficial effects on pain and bone turnover markers

Enrico Bastianelli, CEO of Bone Therapeutics commented: “2015 has been a year of growth and progress for Bone Therapeutics and we ended the year poised for the next stage in our journey towards bringing our new unique bone cell therapies to market.

“We have made significant progress advancing our clinical pipeline, reporting key safety and efficacy data from the Phase II trials of our allogeneic bone cell therapy product ALLOB
® and good progress in the ongoing Phase III programs of our autologous product, PREOB®. We also expanded our activities in spine medicine, an area of significant unmet need, with the initiation of a new trial for the minimally-invasive treatment of failed spinal fusions.

“In 2016, we expect more key clinical data including important efficacy results from the delayed-union and spinal fusion studies with ALLOB
® , and plan to complete recruitment for the spinal fusion study in the first half of this year.  It is also our goal to initiate our first clinical trial in the US by the end of the year.”


Complete press release:



For further information, please contact:

Bone Therapeutics SA

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

For Belgium and International Media Enquiries
Consilium Strategic Communications

Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701

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

Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94



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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 spinal fusion procedures. 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 11 patent families. Further information is available at

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.

Bone Therapeutics S.A. • Rue Auguste Piccard, 37 • 6041 Gosselies • Belgium (Europe) • Phone: +32 (0) 2 529 59 90 • Fax: +32 (0) 2 529 59 93 •