Mont-Saint-Guibert, Belgium, June 1 2022, 7 a.m. CEST – BONE THERAPEUTIC (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces its activity report for the first quarter ended March 31, 2022.
“Bone Therapeutics is now focusing fully on the development of our allogeneic cell therapy product, ALLOB. We stay on target for the delivery of the best results for the Phase IIb ALLOB study, in patients with difficult tibial fractures. We firmly believe that ALLOB has the greatest potential for short-term value creation and are focused on completing the ongoing phase IIb study. This is based on Bone Therapeutics’ success in two clinical studies showing a promising safety profile and efficacy signals in over 60 patients,” said Miguel Forte, MD, PhD, CEO of Bone Therapeutics. “In addition, Bone Therapeutics has now signed a non-binding term sheet to explore a exclusive reverse merger with Medsenic.”
Key strong points
- Bone Therapeutics continues to advance patient enrollment in the Phase IIb study with its allogeneic cell therapy product, ALLOB, in patients with high-risk tibial fractures. This randomized, double-blind, placebo-controlled study evaluates and compares to placebo, in combination with standard stabilization surgery, the potential of ALLOB to accelerate fracture healing after a 3-month follow-up and to prevent complications at an advanced stage.
- In March 2022, Bone Therapeutics realigned its strategic priorities to focus fully on the clinical development of its most advanced asset, ALLOB.
- In April 2022, Bone Therapeutics signed a binding term sheet for a €5 million convertible bond (CB) facility arranged by ABO Securities. Proceeds from the financing will be used to advance the clinical development of Bone Therapeutics’ lead asset, ALLOB. At the end of May 2022, Bone Therapeutics signed the definitive agreement for the subscription of a CB facility for a maximum amount of €5 million with ABO Securities. The CBs will be issued and subscribed in ten tranches. A first tranche of 10 CBs for an overall principal amount of €0.5 million will be subscribed in early June 2022.
- In May 2022, Bone Therapeutics entered into a non-binding term sheet and three-month exclusive discussions with the shareholders of Medsenic, a private clinical-stage biopharmaceutical company incorporated in France specializing in the development of optimized salt formulations of arsenic and their application in inflammatory conditions and other potential new indications.
- Net cash at the end of March 2022 amounted to €6.0 million (1).
- Disciplined cost and cash management will remain a key priority. Net cash burn for the full year 2022 is expected to be between 8 and 10 million euros, assuming normal operations, as the effect of the ongoing COVID-19 outbreak still cannot be completely excluded. The situation continues to be actively and closely monitored. The company expects to have sufficient liquidity to meet its business objectives through the first quarter of 2023, assuming, among other things, the full issuance of the new convertible bond facility.
Outlook for the rest of 2022
- In the ongoing ALLOB phase IIb clinical study in difficult tibial fractures, Bone Therapeutics expects to publish the first results as planned by the first quarter of 2023. However, a delay still cannot be ruled out. If the pandemic continues to impact patient availability, Bone Therapeutics may need to re-evaluate this timeline and, in that event, communicate with the market again.
- Negotiations for ALLOB, with one of Bone Therapeutics’ current Chinese partners, for the global rights agreement are still ongoing but are taking longer than expected. The potential conclusion of a binding definitive agreement is expected in the second quarter of 2022.
- Bone Therapeutics and Medsenic aim to reach an agreement during Q2/Q3 2022, subject to regulatory clearance, outcome of due diligence, shareholder approval and other customary conditions precedent.
(1) Unaudited number
About Bone Therapeutics
Bone Therapeutics is a leading biotechnology company focused on developing innovative products to address significant unmet needs in orthopedics and other diseases. Currently, Bone Therapeutics is concentrateing specifically on the development of its most advanced clinical asset, the allogeneic cell therapy platform, ALLOB.
Bone Therapeutics’ core technology is based on its state-of-the-art allogeneic cell and gene therapy platform with differentiated mesenchymal stromal cells (MSCs) from bone marrow that can be stored at the point of use in the hospital. His The lead investigational drug, ALLOB, represents a proprietary and unique approach to bone regeneration that transforms undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced through Bone Therapeutics’ scalable manufacturing process. Following the approval of the CTA by regulatory authorities in Europe, the Company has initiated the recruitment of patients for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.
Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by an extensive IP (Intellectual Property) portfolio spanning ten patent families as well as know-how. The Company is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at www.bonetherapeutics.com.
For more information, please contact:
Bone Therapeutics SA
Miguel Forte, MD, PhD, President and CEO
Tel: +32 (0)493 09 73 66
For Belgian media and investor enquiries:
Tel: +32 (0)488 40 44 77
For French media and investor enquiries:
NewCap Investor Relations & Financial Communication
Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouille
Tel: +33 (0)1 44 71 94 94
Certain statements, beliefs and opinions contained in this press release are forward-looking and reflect the current expectations and projections of the Company or, if applicable, the directors of the Company regarding 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, may cause actual events, performance or results to differ materially 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. Accordingly, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements contained 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 subsidiaries or the officers or employees of such persons warrant that the assumptions underlying these forward-looking statements are free from error and accept no responsibility for the future accuracy of forward-looking statements. statements contained in this press release or the actual occurrence of anticipated developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.