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  Press Release 30 August 2016  
 
 
 

Regulated information

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.”


Operational Highlights

In the first half of 2016, the Company made important progress across its pipeline:

Osteoporosis:

  • 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.


Spinal fusion:

  • 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.


Osteonecrosis:

  • 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.


Corporate Highlights

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.

Financial Highlights

  • 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.

 
 
 
 
 

Complete press release:
English
Français
Nederlands

 
 

 
 

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
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries
Consilium Strategic Communications

Amber Fennell, Jessica Hodgson and Hendrik Thys
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com
 

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
bone@newcap.eu

 

 
 

 
 
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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 www.bonetherapeutics.com.


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 • www.bonetherapeutics.com