Bone Therapeutics provides fourth quarter 2021 business update and 2022 outlook – GlobeNewswire

REGULATED INFORMATION

Recruitment for ALLOB tibial facture Phase IIb study ongoing and on schedule to release topline data in Q1 2023, despite COVID slowdown

New scientific advisory board appointments to bolster the further development of the next generation iMSCg platform

Discussions for ALLOB global partnership still ongoing. Completion of potential global partnership delayed and now anticipated in Q1 2022

Financial position strengthened following equity fundraising in Q4 2021 with runway expected into Q3 2022

Gosselies, Belgium, 19 January 2022, 7am CET BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, announces today a business update for the fourth quarter, ending 31 December 2021 as well as a business outlook for 2022.

Bone Therapeutics activity in Q4 2021 has resulted in a broadened pipeline and stronger therapeutic potential for the company. The pandemic continues to be a concern across the cell and gene therapy, biopharma and healthcare industries. Bone Therapeutics has, however, put measures in place to reduce the impact of the pandemic on its clinical development., said Miguel Forte, Chief Executive Officer, Bone Therapeutics. In addition, the deal for the global rights for the allogeneic osteoblastic cell therapy product ALLOB, when and if completed, will allow Bone Therapeutics, together with its partners, to ensure the development of ALLOB towards commercialization, while at the same time continue to explore options to expand the iMSCg platform. This includes the development of a next generation of genetically engineered mesenchymal stromal cells and the use of highly scalable and versatile cell sources such as induced pluripotent stem cells. Bone Therapeutics has expanded its Scientific Advisory Board purely for this purpose.

Operational highlights

Corporate highlights

Financial highlights (1)

Outlook for 2022

Financial Calendar 2022

The financial calendar is communicated on an indicative basis and may be subject to change.

(1) Unaudited number

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 other diseases. The Company has a diversified portfolio of cell therapies at different stages ranging from pre-clinical programs in immunomodulation to mid stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell and gene therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment 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 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 http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerLieve Creten, Chief Financial Officer ad interimTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicBert BouserieTel: +32 (0)488 40 44 77bert.bouserie@bepublicgroup.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

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 persons 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.

More:
Bone Therapeutics provides fourth quarter 2021 business update and 2022 outlook - GlobeNewswire