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Bone Therapeutics announces 2019 business outlook and reports year-end 2018 cash position
Phase IIA results with ALLOB in patients undergoing a spinal fusion procedure expected mid-2019
CTA submission planned in H2 2019 to start delayed-union fractures study with ALLOB
Phase III study with JTA-004 in patients with knee osteoarthritis expected to start in H2 2019
Cash burn for the full year 2018 below guidance
Gosselies, Belgium, 22 January 2019, 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 its business outlook for 2019 and reports its cash position for the year ending December 31, 2018.
Outlook for 2019
The Company is on track to report top line data in mid-2019 from the Phase IIA study with its off-the-shelf, allogeneic bone cell therapy, ALLOB, in 32 patients undergoing a spinal fusion procedure.
In H2 2019, the Company plans to submit a clinical trial application (CTA) with the regulatory authorities in Europe to allow the start of a study with ALLOB in patients with delayed-union fractures, using its proprietary, optimised production process. The Company is currently generating the non-clinical data package as required.
The Company expects to submit a CTA with the regulatory authorities and to start the Phase III programme with the enhanced viscosupplement JTA-004, in patients with knee osteoarthritis, in H2 2019.
"We’re delighted with the continued clinical momentum of ALLOB and are further advancing this programme towards commercialization, supported by our new optimized manufacturing process,” said Thomas Lienard, Chief Executive Officer of Bone Therapeutics. “Our focus is now on progressing the late-stage clinical development of the ALLOB platform in delayed-union fractures and JTA-004 in osteoarthritis of the knee. We believe we have a compelling portfolio of programmes with the potential to provide best-in-class solutions to orthopaedics and bone diseases, and we look forward to updating on the progress of these programmes."
Cash position for the full year ended December 31, 2018
Strong focus on cash management and resource allocation optimization resulted in a cash utilization of €13.9 million(1) for the full year 2018 which was below the Company’s guidance. As a result, the net cash position totalled €8.2 million(1) for the year ended December 31, 2018.
Subsequently, in January 2019, Bone Therapeutics received a €1 million milestone payment from licensee Asahi Kasei, after reaching a regulatory milestone following a consultation with the Japanese Regulatory Authority for PREOB. In parallel, Asahi Kasei and the Company are reviewing their options with regards to the future of the PREOB licensing agreement, following termination of the PREOB study in osteonecrosis of the hip.
Therefore, the Company anticipates having sufficient cash to carry out its business objectives into Q4 2019.
(1) Unaudited number
Financial Calendar 2019
• 25 April – Full Year Results 2018 and Annual Report 2018
• 7 May – Q1 2019 Business and Financial Highlights
• 12 June – Annual General Meeting 2019
• 30 August – Half Year Results 2019
• 6 November – Q3 2019 Business and Financial Highlights
Calendar may be subject to change and is communicated on an indicative basis.
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 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 platform derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. In addition, the Company also has JTA-004, a viscosupplement in development for the treatment of knee osteoarthritis.
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.
Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Gunther De Backer, Head of Corporate Communications and Investor Relations
Tel: +32 (0) 71 12 10 00
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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.