The interim financial report is prepared in accordance with article 13 of the Royal Decree on the obligations of issuers of financial instruments admitted to trading on a regulated market and can be accessed on the website of Bone Therapeutics in the section ‘Financial information’.
Bone Therapeutics publishes its interim financial report in English. A French translation of the report will also be made available. In the event of differences between the English and the French version of the report, the original English version will prevail.
Bone Therapeutics announces H1 results for 2016
Encouraging positive safety and efficacy results across Phase II studies
Transition to allogeneic strategy for osteoporosis
Dr Enrico Bastianelli, Chief Executive Officer and Wim Goemaere, Chief Financial Officer, will host a conference call today at 14:00 CEST / 13:00 BST / 08:00 EDT. The call will be conducted in English and a replay will be available for 30 days.
To access the conference call, please dial one of the appropriate number below quoting the conference ID.
BE: +32 (0) 80 04 08 64
FR: +33 (0) 805 63 20 56
US: +1 (0) 8669 669 439
Standard International Dial-In: +44 (0) 1452 555566
Conference ID 71646893
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).
Gosselies, Belgium, 30 August 2016 - BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in bone fracture repair, fracture prevention and spinal fusion, today provides a business update and its financial results for the six-month period ended 30 June 2016, prepared in accordance with IFRS as adopted by the European Union.
Enrico Bastianelli, CEO of Bone Therapeutics commented: “Over the past six months we have made significant progress across our pipeline, with important safety and efficacy results from the ongoing Phase II programs in delayed-union fractures, spinal fusion and osteoporosis and the final results of the Phase IIB osteonecrosis study, underpinning confidence in our platforms.
“Following the promising results of the first patient group in the PREOB® Phase IIA severe osteoporosis trial, we made the important strategic decision to transition the osteoporosis program to allogeneic development. This reflects our belief that ALLOB® has the potential to deliver a better solution for patients and enhance the value of this programme from a future partnership.
“In the second half of 2016, we look forward to communicating efficacy results from the ALLOB® spinal fusion trial and completing recruitment for the interim analysis in the Phase I/IIA delayed-union trial.”
In the first half of 2016, the Company made important progress across its pipeline:
- Positive effects on pain and osteoporosis blood markers after a single intravenous administration of PREOB® in the first patient cohort in the Phase IIA severe osteoporosis trial.
- The strategic decision was made to transition the program for severe osteoporosis to allogeneic development. The initiation of a controlled Phase IIB study with ALLOB® is currently being prepared.
- Presentation of positive 12-month efficacy results of the first patient in the ALLOB® Phase IIA spinal fusion trial at the Clinical Applications of Stem Cells conference.
- Completion of recruitment for the ALLOB® Phase IIA spinal fusion trial without any treatment-related safety concerns, with extension of the study due to high clinical demand and to investigate the detailed dynamics of the fusion.
Impaired fracture healing:
- Primary endpoints met in seven out of eight patients in the Phase I/IIA ALLOB® delayed-union trial, with overall 77% radiological and 68% clinical improvement six months after treatment.
- Expansion of the delayed-union program with ALLOB® into multiple fractures. Twelve patients, diagnosed with multiple delayed-union fractures of long bones, will be enrolled into the study.
- Demonstration of superiority of a single PREOB® administration over standard of care in Phase IIB osteonecrosis study. Data presented at EULAR in June showed that at 24 months, 70% of PREOB® -treated patients responded to treatment, compared to only 37% of patients in the standard of care group.
The Company further strengthened its ability to deliver its growth strategy with the appointment of Benoît Champluvier as Chief Technology and Manufacturing Officer. Mr Champluvier joins from GlaxoSmithKline Vaccines, where he has more than 20 years’ experience of driving innovative and complex bioprocesses, supporting the development and launch of a number of new products. He will be responsible for production and quality control, playing a key role in gearing up Bone Therapeutics’ capacity to manufacture both commercial-scale and clinical trial batches at its specialist facility in Gosselies. Mr Champluvier’s nomination follows the appointment of Thomas Lienard as Chief Business Officer in November 2015 with responsibility for business development, business operations and strategic planning.
Bone Therapeutics celebrated its 10-year anniversary together with guests from the industry and the government, as well as from the international scientific community. Strong testimonials were given by representatives from the medical community involved in Bone Therapeutics’ clinical programs: Click here to view the videos.
- During the first six months of 2016, the operating income amounted to EUR 1.95 million, in line with revenues realized during the first half of 2015 (EUR 1.98 million).
- The operating loss for the period amounted to EUR 5.74 million, compared with EUR 5.36 million in H1 2015.
- The Company ended the first six months of 2016 with EUR 26.60 million in cash and cash equivalents. Cash burn for the period amounted to EUR 7.01 million, in line with cash used over the same period last year excluding the revenues and expenses related to the IPO.
Outlook for the remainder of 2016
In the second half of 2016, Bone Therapeutics will continue its promising Phase II proof-of-concept trials with ALLOB® and plans to communicate important efficacy results of the spinal fusion trial. The Company also expects to complete recruitment for the interim analysis in the Phase I/IIA delayed-union trial. The outcome of this interim analysis, expected in Q2 2017, will determine whether the trial can be stopped at this point and already proceed towards the next phase of development.
An important focus in the second half of 2016 will be the preparation of Bone Therapeutics’ first US clinical trial.
Careful cash management will remain a key priority for the Company, with a strong focus on net cash burn. The Company has sufficient cash to carry out its strategic objectives until early 2018. Cash burn for the full year 2016 is expected to be in order of EUR 14.5-16.0 million.