Bone Therapeutics Business Update for First Quarter 2018

Thomas Lienard, CEO 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."

Business highlights

• 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.

Corporate highlights

• 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.

Financial highlights

• 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.

Outlook

• 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.