REGULATED INFORMATION

Clinical programs running on schedule, including Phase III trial of JTA-004 and Phase IIb trial of ALLOB

Extensive achievements in collaborations and partnerships to enhance development, manufacturing and commercialization capabilities

Strong financial position following fundraising, licencing agreement and optimisation of manufacturing assets

Gosselies, Belgium, 20January 2021, 7am CET BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today provides a business update for the fourth quarter, ending 31 December 2020 as well as a business outlook for 2021.

Bone Therapeutics managed to achieve a highly productive period in the last few months. We have made major advances in nearly all aspects of our activities while executing on our business strategy, said Miguel Forte, Chief Executive Officer, Bone Therapeutics. We recently started treating patients in the Phase IIb study with our allogeneic bone cell therapy product ALLOB. We also completed patient recruitment in the pivotal Phase III trial with the enriched viscosupplement, JTA-004, ready to provide topline data in the third quarter of this year. This will be a critical milestone in the history of Bone Therapeutics. In addition to our clinical programs, we have strongly improved our manufacturing capabilities with a partnership with Catalent, a leading global cell and gene CDMO, and extended the geographic reach of our bone cell therapies into Asia thanks to the licensing agreement with our Chinese partners Link Health and Pregene. We also have explored new grounds in the collaborations with Rigenerand and BioWin consortium. These collaborations will further expand the application of our innovative cell therapy platform and broaden our advanced clinical pipeline with potential new breakthrough developments. Building on the strong foundation of these recent achievements and a strengthened cash position, we are confident for 2021, continuing the progress we have already made and moving our allogeneic cell therapy and advanced biological products through clinical development while exploring new innovations that meet critical needs of patients.

Clinical highlights Q4 2020 to date

Corporate highlights Q4 2020 to date

Financial highlights Q4 2020 (1)

Outlook for 2021

Financial Calendar 2021

29 April Full Year Results & Annual Report 202026 May Q1 2021 Business and Financial Highlights9 June Annual General Meeting 20218 September Half Year Results 202126 October Q3 2021 Business and Financial Highlights

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 and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in Phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell 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 OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.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.

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Bone Therapeutics provides fourth quarter 2020 business update and 2021 outlook - GlobeNewswire

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