Bone Therapeutics completes recruitment of its ALLOB® Phase IIA spinal fusion study

BONE THERAPEUTICS, (Brussels:BOTHE) (Paris:BOTHE) (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and prevention and spinal fusion, today announces that it has completed recruitment of its Phase IIA spinal fusion study for its allogeneic cell therapy product ALLOB^® ahead of schedule. The Company also announced that it is further extending the trial to assess early onset of bone formation and fusion. The trial extension has been submitted and approved by the Ethics Committee and Competent Authorities.

In spine fusion, Bone Therapeutics is investigating a unique approach where an interbody cage is implanted in-between the damaged vertebrae according to the standard-of-care surgical approach and supplemented with ALLOB^® in combination with bioceramic granules. Preclinical results demonstrated that the combination of bioceramics with ALLOB^® cells significantly increased fusion in comparison with bioceramics alone. Safety and efficacy of the implantation of ALLOB^® cells mixed with bioceramic granules in lumbar spinal fusion is evaluated in this Phase IIA study using clinical and radiological parameters at 6 and 12 months after treatment. In total, of the 18 patients enrolled in the study, 16 were eligible and 15 have been treated*. No treatment-related safety concerns were reported. It is expected that efficacy data from the first four patients from the study will be reported by the end of the second quarter of 2016 with the complete set of efficacy results expected in the second quarter of 2017.

In addition to high clinical demand, the extension has been designed to study the detailed dynamics of the fusion. In the extension trial, 16 patients will be treated and evaluated earlier with review of the patient’s progress after 3, 6 and 12 months.

Enrico Bastianelli, Chief Executive Officer of Bone Therapeutics, commented: “We are very happy with the rate at which this trial has progressed. With the spinal fusion program we intend to improve the current surgical procedure and increase its chance of success. The large unmet need of this indication, alongside evidence of fusion earlier than anticipated, have led us to extend the trial. We look forward to communicating on the next efficacy results of this promising trial.”

*One out of the 16 eligible patients was not treated as the surgeon decided to change the surgical procedure.

• About ALLOB®

ALLOB^® is a first-in-class allogeneic differentiated osteoblastic (bone-forming) cell therapy product developed for the treatment of orthopaedic conditions and bone diseases. Allogeneic cell therapy involves the harvesting of cells from a healthy donor, rather than from the treated patient. ALLOB^® is currently being evaluated in three Phase I/IIA clinical trials for delayed-union fractures, spinal fusion and the revision of failed spinal fusions. ALLOB^® has been classified as a tissue engineered product under the ATMP regulation 1394/2007EMA and received orphan drug designation from the EMA (Europe) and FDA (US) for two indications, osteonecrosis and osteogenesis imperfecta.

• About spinal fusion

Spinal fusion is considered the gold standard surgery for treating a broad spectrum of degenerative spine disorders, including degenerative disc disease to relieve pain and improve function. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft, for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Despite the fact that spinal fusion surgery is routine, non-union and failure to relieve lower back pain are unfortunately still frequent as up to 25 to 30% of spinal fusion patients are not completely satisfied with their surgery. Bone Therapeutics’ products are intended to decrease the failure rate of spinal fusion surgeries.

• 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 lumbar fusion for degenerative disease of the spine, including a minimally invasive therapy for failed spinal fusions. 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