Gosselies, Belgium, 4 May 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 provides a business update for the first quarter ended 31 March 2018.
Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “During the first quarter, we have seen continued progress of our ALLOB® programme with the completion of recruitment into our Phase IIA lumbar spine fusion study. With the appointment of Jean Stéphenne as new Chairman and Claudia D’Augusta as senior Non-Executive Director, we have also significantly expanded the expertise in cell therapy, capital markets and corporate development in our leadership team. Supported by a successful convertible bond placement, we are excited to be advancing our products through the clinic closer to patients while preparing our products for commercial use and look forward to further value catalysts as we move through the year.“
- In February 2018, the Company announced the completion of patient recruitment into the Phase IIA lumbar spinal fusion study. This twelve-month, open-label clinical study aims to evaluate the safety and efficacy of the addition of ALLOB® to the standard of care procedure, in which an interbody cage with bioceramic granules is implanted to promote fusion of the lumbar vertebrae.
- Promising interim results for the first 15 patients, reported in September 2017, showed radiological evidence of successful fusion in addition to substantial clinical improvement in function and a strong reduction in back and leg pain.
- Efficacy and safety data for the full set of 32 patients are expected in mid-2019, following a follow-up period of 12 months.
- In February 2018, Jean Stéphenne was appointed Chairman of the Board of Directors. Jean Stéphenne, a highly-experienced life sciences executive, has served in senior leadership roles at numerous biotechnology and pharmaceutical companies, including as Chairman of TiGenix and Chief Executive of GSK Biologicals (now GSK Vaccines).
- Post period, Claudia D’Augusta, Chief Financial Officer of TiGenix, joined the board as a Non-Executive Director, adding more than 20 years’ experience in corporate finance, capital markets and M&A in the biotechnology space.
- In March, Bone Therapeutics secured a total amount of € 19.45 million in committed capital via a private placement of convertible bonds. Some of the investors decided to immediately exercise warrants resulting in immediate gross proceeds of € 6.58 million with 565,773 new shares to be created, increasing the total outstanding shares from 6,849,654 to 7,415,427 ordinary shares.
- As a result, the Company ended the first quarter of 2018 with a cash balance of € 10.42 million.
- The remaining warrants will be exercised over a maximum period of 19 months ending in October 2019, providing an additional proceed of € 12.87 million.
- Bone Therapeutics plans to report final results from the ALLOB® Phase I/IIA delayed-union study in mid-2018.
- A value inflection point is anticipated in the second half of 2018, as the Company expects to present the conclusions of the interim analysis after a one-year follow-up period of the first 44 patients in the Phase III study of PREOB® in osteonecrosis of the hip.
- Additionally, the Company has started preparing for a multicentre, controlled Phase IIB study in delayed-union fractures with ALLOB®.
- Cash burn for the full year of 2018 is expected to be in the range of € 15-16 million. Based on its current priorities, the Company expects to have sufficient cash to carry out its objectives until end Q3 2019.
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.
Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00
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Consilium Strategic Communications
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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.