Bone Therapeutics Announces H1 Results For 2017

Published: Aug 31, 2017

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 2017Patient recruitment completed for the interim analyses of ALLOB® Phase I/IIA delayed-union and PREOB® Phase III osteonecrosis studies

Strengthening of Company's Board with the appointments of Steve Swinson as Chairman, Damian Marron and Dirk Dembski as new Board members

Jean-Luc Vandebroek appointed Chief Financial Officer

Thomas Lienard, Chief Executive Officer and Wim Goemaere, Chief Financial Officer,

will host a conference call and Q&A at 11:00 CEST / 10:00 BST.

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 numbers below quoting the conference ID:

BE: +32 (0) 81 70 00 61

FR: +33 (0) 176 74 24 28

US: +1 (866) 966 9439

Standard International Dial-In: +44 (0) 1452 555 566

Conference ID: 75560121

The presentation will be made available on the Investors section of the Bone Therapeutics website shortly before the call and can be accessed at: http://www.bonetherapeutics.com/en/investors/presentations.

Gosselies, Belgium, 31 August 2017, 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 provides a business update and its financial results for the six-month period ended 30 June 2017, prepared in accordance with IFRS as adopted by the European Union.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: "During the first half of 2017, Bone Therapeutics has continued to advance its allogeneic and autologous bone cell therapy platforms through key clinical studies and notably, we successfully completed the patient recruitment for the interim analysis of the ALLOB® Phase I/IIA delayed-union trial. Results for this interim analysis, as well as in spinal fusion, expected in September, could provide potential value inflection points for the platform, bringing our innovative bone cell therapy platform a step closer to commercialisation. We have also made good progress on our PREOB® Phase III study in osteonecrosis of the hip, completing recruitment of 44 treated patients required for the planned interim analysis of the trial."

"We are also delighted to welcome Jean-Luc Vandebroek to our management team, replacing Wim Goemaere as Chief Financial Officer. His experience in strategy, financial planning and corporate finance will be critical to Bone Therapeutics as we move towards a more commercial phase of our business and we are pleased that Wim, who has decided to pursue an opportunity in the not-for-profit sector, will remain on the Board as a Non-Executive Director and will lead a managed succession during the transition period."

Operational Highlights

ALLOB®

  • In March, Bone Therapeutics completed the recruitment of the 16 patients required for the interim analysis of the ALLOB® Phase I/IIA delayed-union study.

  • In June, the Company was notified by the European Patent Office of its intention to grant a key patent covering Company's first-in-class allogeneic cell therapy technology.

PREOB®

  • In June, the Company announced the 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 its autologous bone cell therapy product, PREOB®.

Corporate Highlights

  • The Company welcomed Steve Swinson, Damian Marron and Dirk Dembski to its Board of Directors, further expanding its knowledge base and experience in the field of orthopedics and cell therapy.

  • Following his appointment, Steve Swinson was elected Chairman of the Board of Directors in June, replacing Michel Helbig, who remains a Non-Executive Director.

  • Post period, the Company appointed Jean-Luc Vandebroek as Chief Financial Officer to replace Wim Goemaere who will take up a senior role within a not-for-profit. Jean Luc previously served as Chief Financial Officer of Fluxys and Moteo Two Wheels/Bihr Europe (Alcopa Group) and has held a number of senior executive positions at the international retailer, Ahold-Delhaize. Jean-Luc's previous experience in strategy, financial planning and corporate finance will help support Bone Therapeutics as it moves its bone cell therapy programmes towards commercialisation.

Financial Highlights

  • During the first six months of 2017, operating income amounted to EUR 1.92 million, in line with revenues realized during the first half of 2016 (EUR 1.95 million)

  • Operating loss for the period amounted to EUR 6.16 million, compared with EUR 5.74 million in H1 2016

  • The Company ended the first six months of 2017 with EUR 12.60 million in cash and cash equivalents. Cash used for the period amounted to EUR 7.70 million, in line with cash used over the same period last year.

Outlook for the remainder of 2017

In September 2017, Bone Therapeutics expects to announce interim results for its two ongoing Phase IIA programs for delayed union and spinal fusion with its allogeneic product ALLOB®. A positive outcome for the 16 delayed-union patients treated and followed over a six-month period could allow the Company to complete this Phase IIA program early and allow the Company to take the necessary steps to initiate the next phase. The interim results for the first cohort of 16 patients recruited and followed over a one-year period in the spinal fusion trial are expected within the same time frame. Both trials continue to recruit in the meantime and recruitment of the total number of patients (32) required for the spinal fusion trial is expected around year-end.

Diligent cash management will remain a key priority, with a strong focus on net cash burn. Cash burn for the full year 2017 is expected to be in the range of EUR 14-15 million. Based on its current strategic priorities, the Company provides guidance that it has sufficient cash to carry out its strategic objectives into Q2 2018.

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.

Our 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.

Our 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 and non-union fractures.

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.

Contacts

Bone Therapeutics SA

Thomas Lienard, 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

For US Media and Investor Enquiries

Westwicke Partners

John Woolford

Tel: + 1 443 213 0506

john.woolford@westwicke.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.

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