Bone Therapeutics Reports Full Year 2017 Results

 

The bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today reports its full year results for the year ending 31 December 2017, prepared in accordance with IFRS as adopted by the European Union.

Thomas Lienard, CEO of Bone Therapeutics, commented: “2017 was a year of important advances for Bone Therapeutics towards our goal of creating efficacious and commercially scalable bone cell therapy products to address large underserved markets. We have made significant progress in the development of our pipeline products with delivery of important clinical data for our allogeneic cell therapy product, ALLOB®, including strong interim efficacy and safety results for the Phase IIA lumbar spinal fusion study and early conclusion of the Phase I/IIA study for delayed-union fractures following positive interim efficacy data.”

“In line with our growth strategy, we have also strengthened our Board and management team with the appointment of Jean Stéphenne as Chairman and Jean-Luc Vandebroek as Chief Financial Officer. We have also made good progress in establishing our manufacturing infrastructure as we continue to mature and develop towards becoming a commercial stage company. In addition, we recently strengthened our balance sheet to enable continued execution of our strategy.”

“With our strengthened balance sheet and our strong team, we look forward to further advancing our pipeline and driving our unique value proposition forward in the field of bone cell therapy.”


Key Highlights:

  • In 2017, we continued to make strong progress in the clinical development of ALLOB®, our flagship allogeneic bone cell therapy technology:
    • Completion of recruitment of the first 16 patients in the ALLOB® Phase I/IIA delayed-union study. Strong interim efficacy and safety results from this first cohort led to an early conclusion of the study as recommended by the DSMB. The Company plans to report final results of the study in mid-2018.
    • Positive efficacy and safety results reported for the first 15 patients in the Phase IIA lumbar spinal fusion trial. Post period, the Company completed patient recruitment of the full set of 32 patients for the Phase IIA lumbar spinal fusion study with efficacy and safety data expected in mid-2019.
    • European Patent Office notified the Company of its intention to grant a key patent for allogeneic bone cell therapy platform.
  • Completion of the recruitment of the 44 treated patients required for the planned interim analysis of the Phase III trial for the treatment of osteonecrosis of the hip with the autologous bone cell therapy product, PREOB®. Conclusions from the interim analysis are expected in H2 2018.
  • Exclusive license agreement signed with Asahi Kasei for the development and commercialisation of PREOB® in Japan.

Financial and Corporate Highlights (including post-period):

  • The Company ended 2017 with € 8.4 million in cash and cash equivalents. Careful management of resources resulted in a cash utilization of € 11.9 million for the full year 2017 (below Company guidance), compared to € 13.3 million for the full year 2016.
  • Operating income was € 4.2 million for the full year 2017, compared to € 4.0 million in full year 2016.
  • Operating loss for the period amounted to € 12.3 million, compared to € 12.8 million in full year 2016
  • Following a successful private placement of convertible bonds in March 2018, the Company secured a total of € 19.45 million in committed funds
  • Appointment of Jean Stéphenne as the new Chairman of the Board of Directors (post period) and Damian Marron and Dirk Dembski as Non-Executive Directors.
  • Appointment of Jean-Luc Vandebroek as Chief Financial Officer, supporting the Company’s progress towards commercialisation.

 

Note

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics’ technology is based on a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

The Company’s primary clinical focus is ALLOB®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis of the hip.

Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

 

 

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