Gosselies, Belgium, 11 March 2020, 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 2019, prepared in accordance with IFRS as adopted by the European Union.
“During the past year, Bone Therapeutics has laid a strong foundation for advancing our key assets, the allogeneic cell therapy platform ALLOB and the enriched protein solution JTA-004, into the next phase of clinical development and beyond,” said Miguel Forte, MD, PhD, CEO of Bone Therapeutics. “We have obtained additional clinical evidence supporting the safety and efficacy for ALLOB in patients undergoing spinal fusion procedures. We have also successfully implemented the optimised allogeneic cell therapy manufacturing process and additionally submitted the clinical trial applications for the crucial Phase III JTA-004 and Phase IIb ALLOB studies. With the preparation of both clinical trials complete, we are fully focussed on timely execution of our clinical programmes and delivering our business and partnering strategy in 2020. This will enable us to move toward our goal of creating innovation solutions that will make a true difference in the lives of patients suffering from debilitating orthopaedic conditions.”
Clinical and operational highlights during 2019
- Reported positive results for the Phase IIa study with the allogeneic off-the-shelf cell therapy platform, ALLOB in 30 patients undergoing lumbar spinal fusion procedures at 12 months post-treatment
- Renewed the GMP (Good Manufacturing Practices) certification of Bone Therapeutics’ own manufacturing site for the production of human cell therapy products
- Completed the Clinical Trial Application (CTA) submission to the competent authorities to initiate the pivotal Phase III study with the enhanced protein solution, JTA-004, in patients with knee osteoarthritis
- Started the CTA submission process in Europe for a Phase IIb clinical trial with its allogeneic bone cell therapy product, ALLOB, in patients with tibial fractures at risk for delayed healing
- Asahi Kasei and Bone Therapeutics agreed to formally end the PREOB licensing agreement, following the previously announced discontinuation of the autologous cell therapy program at the end of 2018.
Corporate highlights 2019
- Appointed Miguel Forte as Chief Executive Officer, Benoit Moreaux as Chief Scientific and Technology Officer and Olivier Godeaux as Chief Medical Officer
- Strengthened its Board of Directors with the appointment of Gloria Matthews, DVM, PhD, DACVS, as Independent Director.
Financial highlights 2019
- Secured a total of € 8.5 million through private placement of new shares and non-dilutive subordinated bonds
- Revenues and operating income of € 4.92 million
- Operating loss for the period amounted to € 9.58 million, compared to € 11.47 million for the full year 2018.
- Lower than anticipated net cash burn of € 11.48 million vs € 12-13 million previously guided
- Year-end cash position of € 8.63 million compared to € 8.17 million year-end 2018.
Outlook for the remainder of 2020
Bone Therapeutics anticipates starting patient recruitment for the Phase III study with JTA-004, for the treatment of pain in patients with knee osteoarthritis in Q1 2020, subject to the approval of the CTA by the regulatory authorities.
The company has started the CTA submission process in Europe for a Phase IIb clinical trial with its allogeneic bone cell therapy product, ALLOB, in patients with tibial fractures at risk for delayed healing, using its optimized production process. The company expects to enroll the first patient in Q2 2020.
In the second half of 2020, the company expects to report results from the 2-year follow-up period of the Phase IIa study with ALLOB in patients undergoing a spinal fusion procedure.
Good cost and cash management will remain a key priority. The net cash burn for the full year 2020 is expected to be in the range of € 15-17 million assuming normal operation as the effect of the ongoing COVID-19 epidemy cannot be excluded. The situation will be actively and closely monitored. The company anticipates having sufficient cash to carry out its business objectives into Q3 2020.
In this context, strengthening the cash position is a key priority. The company is currently evaluating and working on different financing options and plans to raise new funds from the capital markets and/or through alternative funding strategies.
Miguel Forte, MD, PhD, CEO, and Jean-Luc Vandebroek, CFO, will host a conference call today at 5pm CET / 11am EST / 8am PST. To participate in the conference call, please select your dial-in number from the list below quoting the conference ID 7547944#:
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
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: 7547944#
About Bone Therapeutics
Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.
Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering Phase III development for the treatment of pain in knee osteoarthritis. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) to start the pivotal Phase III program has been submitted to the regulatory authorities in Europe and Hong Kong SAR. The trial is expected to start in Q1 2020.
Bone Therapeutics’ other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and 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, scalable cutting-edge manufacturing process. Following the promising Phase IIa efficacy and safety results for ALLOB, the Company has started the CTA submission procedure with the regulatory authorities in Europe to start the Phase IIb clinical trial with ALLOB in patients with difficult-to-heal fractures, using its optimized production process.
The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.
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. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at www.bonetherapeutics.com.
Bone Therapeutics SA
Miguel Forte, MD, PhD, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00
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