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  Press Release 17 February 2016  
 
 
 

Regulated information


Bone Therapeutics Provides Business Update for the Fourth Quarter of 2015

 

Cash and cash equivalents of EUR 33.6 million1 on 31 December 2015, in line with expectations

EUR 5 million new funding granted by the Walloon Region in 2015

Thomas Lienard appointed as Chief Business Officer

Orphan Drug Designation for ALLOB® in osteogenesis imperfecta in Europe and the US

Recruitment on track for spinal fusion trial with 75% of patients treated to date
 

Gosselies, Belgium, 17 February 2016 - BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, today provides a trading update ahead of the Company’s Full Year 2015 results on 14 April 2016.

Enrico Bastianelli, CEO of Bone Therapeutics commented: "Since our IPO last year, we have reported solid clinical achievements demonstrating the absence of safety concerns in all ongoing trials including our Phase II osteoporosis trial with our autologous product PREOB®. With three ongoing Phase II trials with our new allogeneic off-the-shelf cell therapy product, ALLOB®, the program is well on its way with more than 20 patients treated without any safety concerns so far.

“We have also been able to manage cash flow effectively with further support from non-dilutive grants from the Walloon Region, resulting in a cash position at year end, well in line with our expectations. We start 2016 from a position of strength and look forward to reporting further efficacy results from across the pipeline, demonstrating the value of our unique cell therapy products
."

Financial highlights

The Company ended the fourth quarter of 2015 with EUR 33.6 million1 in cash, which was well in line with company expectations.

During the last quarter of 2015, the Company was awarded EUR 5 million in new funding from the Walloon Region to support its preclinical research projects, an amount equalling 13.5% of the Company’s IPO proceeds.

Operational and corporate highlights

Recruitment of the first half of patients in the ALLOB® Phase IIA spinal fusion trial was completed in December. Eight out of a total of 16 patients were treated without any complications or safety issues.

In November, the Company’s allogeneic bone cell therapy product, ALLOB®, received orphan drug designation from the EMA and FDA for osteogenesis imperfecta, a rare genetic disorder that causes bone fragility, fractures and deformities.

The Company welcomed Thomas Lienard to the team as Chief Business Officer in November. Mr Lienard has assumed responsibility for activities in business development, business operations and strategic planning.

Post period highlights

Post-period, the Company announced that 12 patients have now been treated in the Phase IIA spinal fusion trial, thus completing 75% of recruitment.

The full 2015 Annual Results will be announced on April 14, 2016.


1 Unaudited figure

 
 
 
 
 

To read this press release in French or Dutch, please follow the link below:
FR - NL

 
 

 
 

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,
Lindsey Neville 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.fr

 

 
 

 
 
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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