Bone Therapeutics Provides Business Outlook and Announces its Financial Calendar for 2018
Completion of recruitment in its Phase IIA spinal fusion trial with ALLOB®, following positive interim data, expected in Q1
Final results expected in the Phase I/IIA trial of ALLOB® in delayed union fractures in H1
Interim results expected for the first 44 patients in the Phase III study of PREOB® in osteonecrosis after one-year follow-up, with potential for early trial stop, in H2
Cash and cash equivalents of EUR 8.4 million(1) end of 2017
Cash utilization for the full year 2017 below guidance
Gosselies, Belgium, 23 January 2018, 7am CET – Bone Therapeutics (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today provides business outlook and its cash position end of 2017.
Thomas Lienard, CEO of Bone Therapeutics, commented: “2017 was a year of significant progress in our key clinical programs. We reported positive interim data for the Phase IIA spinal fusion and delayed-union fracture studies, underpinning the potential of our allogeneic product ALLOB® in large bone conditions. We also finalised the recruitment for the interim analysis of our pivotal PREOB® Phase III hip osteonecrosis study, potentially paving the way for our first commercial product. The partnership we signed with Asahi Kasei for PREOB® in 2017 further underscores the clinical and commercial potential of our unique regenerative approach.”
“We remain focused on the development of our strong bone cell therapy pipeline and look forward to achieving further important milestones, in particular with ALLOB®, our allogeneic bone cell therapy product, with further clinical progress expected in 2018.”
Cash position
The Company started 2018 with EUR 8.4 million(1) in cash. Careful management of resources resulted in a cash utilization of EUR 11.9 million(1) for the full year 2017, compared to EUR 13.3 million for the full year 2016, which was below the Company’s guidance. Cash management and financing remain key priorities for the Company.
Outlook for 2018
Bone Therapeutics anticipates completing recruitment of the required 32 patients for the ALLOB® spinal fusion Phase IIA clinical trial in the first quarter of 2018. Additionally, it plans to report the final results of the ALLOB® Phase I/IIA delayed-union study during the first half of 2018.
A potential value inflection point is expected in the second half of 2018, as the Company expects to present the interim results after a one-year follow-up period of the first 44 patients in its Phase III study of PREOB® in osteonecrosis. Strong efficacy results from this interim analysis could allow the trial to be stopped at this stage. Additionally, the preparation for a multicentre, controlled Phase IIB study for the treatment of difficult fractures with ALLOB® has been initiated, and the start of the study is anticipated in the second half of 2018.
Financial Calendar 2018
25 April 2018 – Full Year Results 2017 and Annual Report 2017
4 May 2018 – Q1 2018 Business and Financial Highlights
13 June 2018 – Annual General Meeting 2018
30 August 2018 – Half Year Results 2018
7 November 2018 – Q3 2018 Business and Financial Highlights
(1) Unaudited figure
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 of the hip and is also partnered with Asahi Kasei Corporation for the development and commercialisation of PREOB® in Japan.
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.
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.