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 (http://bonetherapeutics.com/en/investors/presentations). 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.”