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.
- 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)
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.
The interim financial report is prepared in accordance with article 13 of the Royal Decree on the obligations of issuers of financial instruments admitted to trading on a regulated market and can be accessed on the website of Bone Therapeutics in the section ‘Financial information’.
Bone Therapeutics publishes its interim financial report in English. A French translation of the report will also be made available. In the event of differences between the English and the French version of the report, the original English version will prevail.
About Bone Therapeutics
Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy and an innovative biological product in later-stage clinical development across a number of disease areas, which target markets with large unmet medical needs and limited innovation.
Bone Therapeutics’ core technology is based on its allogeneic cell therapy platform (ALLOB) which uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, cutting-edge manufacturing process.
The Company’s ALLOB product pipeline includes a cell therapy product candidate that is expected to enter Phase II/III clinical development for the treatment of delayed-union fractures and a Phase II asset in patients undergoing a spinal fusion procedure. In addition, the Company is also developing an off-the-shelf protein solution, JTA-004, which is expected to enter Phase III development for the treatment of pain in knee osteoarthritis.
Bone Therapeutics’ cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. 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
For Belgium and International Media Enquiries:
Consilium Strategic Communications
Tel: +44 (0) 20 3709 5701
For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouillé
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.