Bone Therapeutics announces 2018 full year results

Regulated Information

Significant progress across all areas of the business

Positioned to move the clinical pipeline into late-stage development

Proprietary, optimised commercial production process fully operational

Thomas Lienard, CEO, and Jean-Luc Vandebroek, CFO, will host a conference call today at 13:00 CET / 12:00 BST. To participate in the conference call, please select your dial-in number from the list below quoting the conference ID:

Belgium:  +32 (0)800 48 740  /  +32 (0)2 400 98 74

France:  +33 (0)805 103 028  /  +33 (0)1 76 70 07 94

United Kingdom:  +44 (0)800 376 7922  /  +44 (0)844 571 8892

United States:  +1 (866) 966 1396  /  +1 (631) 510 7495

Conference ID:  1789228#

Shortly prior to the call, the presentation will be made available on the Investors section of the Company’s website. A replay will be available by dialling the following number +44 (0)333 300 9785 / +33 (0)1 70 95 03 48 and by using the conference ID: 1789228#

Gosselies, Belgium, 1 March 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 announces its business update and full year financial results for the year ending 31 December 2018, prepared in accordance with IFRS as adopted by the European Union.

Thomas Lienard, CEO of Bone Therapeutics, commented: “During the past year, we have made substantial progress in all areas of our business. We are now progressing the late-stage clinical development of the ALLOB platform in delayed-union fractures and JTA-004 in osteoarthritis of the knee. We look forward to continuing to report on our progress and to execute on our strategy to address high unmet needs for patients suffering from debilitating bone related disorders.”

Clinical and operational highlights

• Achieved positive final results for the Phase I/IIa study with ALLOB in 21 patients with delayed-union fractures.
• Completed patient recruitment in the ALLOB Phase IIa lumbar spinal fusion study.
• Optimised the allogeneic manufacturing process to improve consistency, scalability, cost effectiveness and ease of use, factors critical for the successful development of a commercial cell therapy product.
• Further demonstrated the potent osteogenic properties of the allogeneic cell therapy platform, presented at the Annual Meeting of the European Orthopaedic Research Society (EORS).
• Reported positive Phase IIb efficacy results with JTA-004 in patients with knee osteoarthritis, showing a statistically significant improvement in pain relief compared to a leading viscosupplement.
• Pipeline focused on the clinical development of ALLOB and JTA-004, following discontinuation of the autologous product, PREOB, in osteonecrosis of the hip. 

Corporate highlights

• Further strengthened the Board of Directors with the appointment of Jean Stéphenne as Chairman, Jean-Luc Vandebroek as Executive Director and Claudia D’Augusta as Independent Director.
• Appointment of Linda Lebon as Chief Regulatory Officer, who will play a crucial role in defining the regulatory pathway for the late-stage clinical assets.

Financial highlights

• Revenues and operating income of € 5.1 million, up 20.5% compared to 2017.
• Operating loss for the period amounted to € 11.5 million, compared to € 12.3 million for the full year 2017.
• Lower than anticipated net cash burn of € 13.9 million vs € 15-16 million previously guided.
• Year-end cash position of €8.2 million compared to €8.4 million year-end 2017.
• Secured a total of € 19.45 million in committed funds following the successful private placement of convertible bonds.
  
  

Post-period highlights

• Subsequent analysis of the unblinded interim data of the Phase III PREOB study in patients with hip osteonecrosis demonstrated that PREOB had a clinical effect, which was in line with the previous reported results from the Phase II study. However, this analysis also revealed that the control group, which consisted of core decompression alone, performed much better than what was originally anticipated from historical clinical studies. This could be related to improvements of the core decompression techniques in recent years, and hence may have led to a reduced difference in responder rate between the control arm and PREOB group, leading to the discontinuation of the Phase III trial. Based on the preclinical data, manufacturing and intellectual property experience with PREOB, the Company generated the knowledge to develop ALLOB, its patented allogeneic cell therapy platform. ALLOB’s optimised production process significantly increases the production yield, substantially reducing production costs, and the product is delivered to physicians in a ready-to-use cryopreserved formulation, to the benefit of patients.
• Achieved a regulatory milestone as part of its PREOB collaboration with Asahi Kasei, triggering a €1 million success fee. In parallel, Asahi Kasei and the Company are reviewing their options regarding the future of the PREOB licensing agreement, following termination of the PREOB study in osteonecrosis of the hip in Europe.
• Further demonstrated the potent osteogenic properties of its allogeneic cell therapy product at the Annual Meeting of the Orthopaedic Research Society (ORS).
• Strengthened the executive management team with the appointment Benoît Moreaux as Chief Technology & Manufacturing Officer.

Outlook for the remainder of 2019

• The Company expects to report top line data in mid-2019 from the Phase IIa study with ALLOB in 32 patients undergoing a lumbar spinal fusion procedure.
• In the second half of 2019, the Company plans to submit a clinical trial application (CTA) with the regulatory authorities in Europe and the United States to allow the start of a Phase IIb/III clinical trial 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.
• Also, in the second half of 2019, the Company plans to submit a CTA with the regulatory authorities in Europe and the United States for the Phase III programme with JTA-004 in patients with knee osteoarthritis.
• Good cost and cash management will remain a key priority. The net cash burn for the full year 2019 is expected to be in the range of € 13-14 million. The Company anticipates having sufficient cash to carry out its business objectives until the end of 2019, taking into account the € 5.18 million to be received under the convertible bond programme.

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:

Contacts

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

International Media Enquiries:

Consilium Strategic Communications

Marieke Vermeersch

Tel: +44 (0) 20 3709 5701

For French Media and Investor Enquiries:

NewCap Investor Relations & Financial Communications

Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau

Tel: + 33 (0)1 44 71 94 94

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.

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