Regulated Information

Bone Therapeutics reports half year 2019 results

Strong Phase IIa safety and efficacy results for ALLOB in patients undergoing a lumbar spinal fusion procedure

Successfully raised €8.5 million through private placement of new shares and non-dilutive subordinated bonds

Development and progress of pipeline assets on track

Management to host conference call today at 11:00 am CEST today - details provided below

Gosselies, Belgium, 30 August 2019, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapeutics to address high unmet medical needs in orthopaedics and bone diseases, today provides a business update and its financial results for the six-month period ended 30 June 2019, prepared in accordance with IFRS as adopted by the European Union, and the outlook for the remainder of the year.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “The recently reported strong Phase IIa efficacy and safety results for our allogenic cell therapy product, ALLOB, in a second indication, together with our optimised, scalable proprietary cell manufacturing process, further underscore the potential of our technology to address high unmet needs in orthopaedics. The new funds recently raised allow us to execute on our business strategy focused on the further development of our innovative proprietary product pipeline. We are on track to submit two clinical trial applications by year-end to allow the start of late-stage clinical development for ALLOB in patients with delayed union fractures and JTA-004 to treat pain in patients with osteoarthritis of the knee. We continue to further build on the progress we made and look forward to reporting on the upcoming value inflection milestones.”
 
Operational and Corporate Highlights

• In June, Bone Therapeutics announced the successful completion of the Phase IIa study of its allogeneic cell therapy product, ALLOB, in patients undergoing a lumbar spinal fusion procedure. The results demonstrated that treatment with ALLOB resulted in significant clinical and radiological improvements and that ALLOB was generally well-tolerated, consistent with previous reported results.
• In June, the Company significantly strengthened its Board of Directors with the appointment of Gloria Matthews, DVM, PhD, DACVS, an American citizen, as Independent Director. Gloria has more than 20 years of research and clinical experience in orthopaedics, osteoarthritis, rheumatology and cartilage repair with extensive expertise in medical devices, biologicals, and regenerative medicine. She has built an impressive business and medical network over the years and her knowledge will be invaluable as the Company is entering a next stage in its corporate development.
• In March, Olivier Godeaux, MD and Benoît Moreaux, PhD were appointed as Chief Medical Officer and Chief Scientific and Technology Officer respectively. Dr. Olivier Godeaux is a seasoned biopharmaceutical industry executive with a proven track record in advancing drug candidates through to regulatory approval and commercial launch. With 20 years of experience, Benoit Moreaux brings extensive industry expertise in strategic operations planning and execution, as well as global quality assurance.

 
Financial Highlights

• On 27 June, Bone Therapeutics announced that it successfully raised € 8.5 million in gross proceeds through a private placement of new shares via an accelerated bookbuild offering, and a non-dilutive subordinated bond placement.
• During the first six months of 2019, total operating income amounted to € 1.68 million, a slight decrease compared to the same period in 2018 (€ 1.88 million).
• Operating loss for the period amounted to € 5.44 million, compared to € 6.08 million in H1 2018.
• The Company ended the first six months of 2019 with € 13.16 million in cash and cash equivalents. Cash used for the period amounted to € 5.12 million, excluding net proceeds obtained from financing activities, compared to € 7.90 million over the same period of 2018.

 

Outlook for the remainder of 2019

• In the second half of 2019, the Company plans to submit a clinical trial application (CTA) with the regulatory authorities to start a Phase II/III programme with its allogeneic cell therapy product, ALLOB, in patients with delayed-union fractures, using its proprietary, optimised production process.
• Also, in the second half of 2019, the Company plans to submit a CTA with the regulatory authorities to start a Phase III programme with its off-the-shelf product for osteoarthritis pain, JTA-004.
• Good cost and cash management will remain a key priority, as already reflected in our operating expenses. Cash used in H2 2019 is expected to amount to € 6-7 million largely driven by external costs associated with increased clinical development activities due to the preparation of new clinical studies and partially offset by decreased internal costs, resulting in an anticipated net cash burn of € 12-13 million for the full year 2019. Taking into account the total gross proceeds of € 8.5 million raised through the Private Placement and the Bond Issuance in June, the convertible bonds and the recoverable cash advances granted by the Walloon Region, the Company anticipates having sufficient cash to carry out its business objectives into Q3 2020.
• The Company will be presenting pre-clinical and clinical results at the World Congress on Rheumatology & Orthopedics (WCRO) (26-27 September, Paris, France) and at the European Orthopaedic Research Society (EORS) Annual Meeting (2-4 October, Maastricht, the Netherlands).
• Management will attend the following upcoming investor and partnering conferences:
  • Sachs Associates Biotech in Europe Forum (25-26 September, Basel, Switzerland)
  • KBC Securities Life Sciences Conference (26 September, Brussels, Belgium)
  • VFB Expert Tips Day (28 September, Ghent, Belgium)
  • Investir Day (3 October, Paris, France)
  • BioJapan (9-11 October, Yokohama, Japan)
  • Bio-Europe (11-13 November, Hamburg, Germany)
  • Bryan, Garnier & Co European Healthcare Conference (12-13 November, Paris, France)
  • Finance Avenue (16 November, Brussels, Belgium)
  • BioCentury & Bayhelix China Healthcare Summit (18-20 November, Shanghai, China)

 
 
Conference call
 
Thomas Lienard, Chief Executive Officer, and Jean-Luc Vandebroek, Chief Financial Officer, will host a conference call today at 11:00 am CEST. To participate in the conference call, please select your phone number below and use the conference ID 2868386:
 
Belgium: +32 (0)2 400 98 74
France: +33 (0)1 76 700 794
United Kingdom: +44 (0) 844 571 8892
United States: +1 631 1510 7495
 
The presentation will be made available on the Investors section - Presentations of the Bone Therapeutics website shortly prior the call.
 
To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled start timing.