25 April 2018

Bone Therapeutics Reports Full Year 2017 Results

 

  • Strong clinical progress in ALLOB® spinal fusion and delayed union trials

  • Leadership team strengthened with appointments of Jean Stéphenne as Chairman of the Board (post period) and Jean-Luc Vandebroek as CFO

  • Exclusive licensing agreement signed with Asahi Kasei for development and commercialization of PREOB® in Japan

  • € 19.45 million of commitment secured following private placement of convertible bonds (post period)

Thomas Lienard, CEO, and Jean-Luc Vandebroek, CFO, will host a conference call today at 13:00 CET / 12:00 BST. To access the conference call, please dial one of the appropriate numbers below quoting the conference ID:

Belgium: +32 (0)81 70 00 61

France: +33 (0) 805 63 20 56

US: +1 (866) 966 9439

UK: +44 (0) 1452 555 566

Conference ID: 9566757

The presentation for the call will be made available on the Investors section of the Bone Therapeutics website shortly before the call. A replay will be available through dialling the following number +44 (0)1452 550 000 / +33 (0) 805 11 13 37 and by using the conference ID: 9566757#

 

Gosselies, Belgium, 25 April 2018, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), 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.

“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.”

Thomas Lienard

CEO of Bone Therapeutics

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.

 

Key Financials (IFRS)

(€ million)

FY 2017

FY 2016

Operating income

4.21

4.01

Operating expenses

(16.51)

(16.81)

      R&D

(13.12)

(13.65)

      G&A

(3.39)

(3.16)

Operating result

(12.29)

(12.80)

Net financial result

(0.48)

(0.28)

Net result

(12.77)

(13.02)

Net cash flow

(11.89)

(13.31)

      Operating activities

(11.02)

(11.37)

      Investing activities

(0.42)

(0.58)

      Financing activities

(0.46)

(1.36)

Cash position at 31 December

8.41

20.30

 

 About Bone Therapeutics

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.

 

For further information, please contact: 

Bone Therapeutics SA

Tel: +32 (0)71 12 10 00

Thomas Lienard, Chief Executive Officer

Jean-Luc Vandebroek, Chief Financial Officer

investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:

Consilium Strategic Communications

Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville

 

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

For US Media and Investor Enquiries:

Westwicke Partners

John Woolford

 

Tel: + 1 443 213 0506

john.woolford@westwicke.com

 

Please click here for full results statement

 

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.


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