REGULATED INFORMATION  

Ongoing clinical progress across pipeline, including Phase III and IIb clinical trials

Multiple new collaborations and partnerships to enhance development, manufacturing and commercialization capabilities

Product portfolio broadening from orthopedics into inflammatory conditions, leveraging Bone Therapeutics’ allogeneic MSC platform

Three successful funding operations, licensing agreement and optimization of manufacturing assets

Management to host conference call today at 2pm CEST / 8am EST - details provided below

Gosselies, Belgium, 29 April 2021, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces its business update and full year financial results for the year ending 31 December 2020, prepared in accordance with IFRS as adopted by the European Union.

“Bone Therapeutics has made significant clinical progress in the last year, in spite of the pandemic. This includes completing the recruitment phase of its Phase III clinical study with JTA for knee osteoarthritis, initiating treatment of patients in its Phase IIb study with ALLOB for difficult tibial fractures, and reporting positive efficacy in a Phase IIa study with ALLOB in spinal fusion. Bone Therapeutics also considerably strengthened its capabilities with a major licensing agreement for ALLOB in China and the Southeast Asia region, signed a manufacturing collaboration agreement including the sale of its manufacturing subsidiary, and a process development partnership with an MSC specialist. Furthermore, Bone Therapeutics strengthened its leadership team by appointing Stefanos Theoharis as Chief Business Officer and Tony Ting as Chief Scientific Officer,” said Miguel Forte, MD, PhD, CEO of Bone Therapeutics. “As a result of this ongoing re-engineering, Bone Therapeutics is putting in place the resources, management and expanding partnerships to deliver clinical success and expansion of the platform. Bone Therapeutics is now able to expand the potential of its therapies from orthopedics into inflammatory conditions, leveraging Bone Therapeutics’ allogeneic Mesenchymal Stromal Cell platform through a clear focus on the ‘professionalization’ of MSC biology with cells primed for specific therapeutic targets.”

Clinical and operational highlights (including post-period events)

• Completed the patient recruitment in the pivotal Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis on schedule. Topline results are expected in the third quarter of 2021.
• Initiated treatment of first patients in the Phase IIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures. There has been a slow start and slight delay in recruitment due to the pandemic, but topline results are still expected as planned in H2 2022 in view of early stage of the study conduct and recruitment together with successful initial mitigation actions.
• Reported positive efficacy and safety results for the Phase IIa study with the allogeneic off-the-shelf cell therapy platform, ALLOB in patients undergoing lumbar spinal fusion procedures at 24 months post-treatment.
  
  

Corporate highlights (including post-period events)

• Signed exclusive licensing agreement with Link Health and Pregene to develop and commercialize ALLOB in China and Southeast Asia, with up to €55 million total in upfront and milestone payments in addition to tiered double-digit royalties.
• Signed a manufacturing collaboration and share purchase agreement with Catalent, Inc. to streamline the production of ALLOB and to sell manufacturing subsidiary, Skeletal Cell Therapy Support SA (SCTS), for gross proceeds of €12 million, generating net proceeds of approximately €6 million after deduction of SCTS’ debt, cash adjustments and part of Bone Therapeutics’ existing liabilities.
• Signed a process development partnership with the mesenchymal stromal cell (MSC) specialist, Rigenerand.
• Received in total €1.6 million in grants and non-dilutive funding from the Walloon Region, Belgium, to advance Phase III clinical study with JTA-004 as well as for research and preparation of clinical development of BT-20, a new allogeneic and off-the-shelf cell therapy product, targeting inflammatory conditions.
• Awarded €3 million in funding supported by the Walloon Health Association, BioWin to develop personalized, tissue engineered bone implants with industry and academic partners.
• Strengthened leadership team with the appointments of Stefanos Theoharis, PhD as Chief Business Officer and Antony Ting, PhD as Chief Scientific Officer.
  
  

Financial highlights

• Raised total gross proceeds of €16.2 million through three financial operations in the second and fourth quarter with current and new institutional investors both in Europe and in the US.
• Revenues and operating income of €3.7 million.
• Due to increased clinical activities, operating loss for the period amounted to €15.0 million, compared to €8.0 million for the full year 2019.
• Cash used for operating activities amounted to €16.3 million for the full year 2020 in line with company’s guidance of €15-16 million.
• Year-end cash position of €14.7 million compared to €8.6 million year-end 2019.
  
  

Outlook for the remainder of 2021

• Bone Therapeutics aims to report topline results for the 3-month primary endpoint and 6-month follow-up period in the third quarter of 2021 for its pivotal Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis.
• For the ongoing Phase IIb ALLOB clinical study in difficult tibial fractures, to compensate the impact of the pandemic on site activities due to staff availability and patient recruitment due to less accidents, Bone Therapeutics and its partners will continue to take action to intensify the recruitment through training, information, best practices sharing and close monitoring of progress. The initial result of these activities has already impacted positively patient recruitment.
• Bone Therapeutics will continue to hold discussions with potential partners to explore business opportunities as JTA-004 is approaching the announcement of pivotal Phase III topline results and ALLOB is being evaluated in a double-blind, placebo-controlled, proof-of-concept Phase IIb study.
• Bone Therapeutics will continue its discussions with the US FDA (Food and Drug Administration) in preparation for the next steps in the clinical development of JTA-004 and ALLOB in the US.
• Bone Therapeutics plans to continue to expand its allogeneic differentiated MSC based cell therapy platform, beyond ALLOB, into other therapeutic indications.
• Disciplined cost and cash management will remain a key priority. The net cash burn for the full year 2021 is expected to be in the range of €16-17 million, assuming normal operation as the effect of the ongoing COVID-19 epidemic cannot be excluded. The situation will be actively and closely monitored. The company anticipates having sufficient cash to carry out its business objectives into November 2021.
  
  

Conference call

Miguel Forte, MD, PhD, Chief Executive Officer, and Jean-Luc Vandebroek, Chief Financial Officer, will host a conference call today at 2:00 pm CEST / 8:00 am EST. To participate in the conference call, please select your dial-in number from the list below quoting the conference ID 958 8247 7967#:

Belgium: +32 2 290 9360
France: +33 1 7095 0103
United Kingdom: +44 208 080 6592
United States: +1 646 876 9923

The presentation will be made available on the Investors section - Presentations of the Bone Therapeutics website shortly prior to the call.

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 www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SA
Miguel Forte, MD, PhD, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)71 12 10 00
investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:
Bepublic
Catherine Haquenne
Tel: +32 (0)497 75 63 56
catherine@bepublic.be

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

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
bone@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 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.

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