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, saidMiguel 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
Corporate highlights 2019
Financial highlights 2019
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 thePhaseIIa 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.
Conference call
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 74France: +33 (0)805 103 028 / +33 (0)1 76 70 07 94United Kingdom: +44 (0)800 376 7922 / +44 (0)844 571 8892United 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 Companys 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 http://www.bonetherapeutics.com.
Contacts
Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com
International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: 44 (0)20 8943 4685neil@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 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.
Attachment
Follow this link:
Bone Therapeutics announces 2019 full year results - OrthoSpineNews
- 4 Reasons To Save Baby Teeth And Ways To Preserve Them - MomJunction - October 6th, 2024
- Stem Cells May Help In Treatment of Tuberculosis, But Challenges Remain: Study - News18 - April 23rd, 2023
- Buccal Fat Pad as a Potential Source of Stem Cells for Bone ... - Hindawi - December 20th, 2022
- Difference Between Adult and Embryonic Stem Cells - December 20th, 2022
- Nicklas Brendborg: Keeping your mouth clean is one of the few easy things you can do to extend your life - EL PAS USA - November 17th, 2022
- A Breakthrough in the Era of Calcium Silicate-Based Cements: A Critical Review - Cureus - September 4th, 2022
- Effect of Puerarin on New Bone Formation In Vivo | DDDT - Dove Medical Press - August 27th, 2022
- The Tokyo Medical and Dental University (TMDU) team succeeded with the world's first Mini Organ transplantation to a patient with Ulcerative Colitis... - August 27th, 2022
- Stem cell-based biological tooth repair and regeneration - PMC - June 26th, 2022
- Where Stem Cells Are Found, & the Difference That Makes | Cryo-Cell - June 26th, 2022
- Stem Cells International | Hindawi - June 26th, 2022
- The surprising science of breast milk - BBC - June 26th, 2022
- Plug-and-Play Human Organ-on-a-Chip Can Be Customized to the Patient - SciTechDaily - May 8th, 2022
- Twelve Rutgers Professors Named Fellows of the American Association for the Advancement of Science - Rutgers Today - January 30th, 2022
- Mouth Sores from Chemo: Symptoms, Causes, and Treatments - Healthline - February 19th, 2021
- Tooth Regeneration Market to Exhibit Steadfast Expansion by 2027 | Unilever, Ocata Therapeutics, Integra LifeSciences, CryoLife, BioMimetic... - February 14th, 2021
- Using 3D Printing to Develop Bone-Like Structures that Contain Living Cells - AZoM - February 14th, 2021
- Fear of Covid keeps patients away from dental clinics resulting in an increased need of treatment. - ETHealthworld.com - February 9th, 2021
- 3D medical printing making strides, and helping patients do the same - MedCity News - February 9th, 2021
- Global Cord Blood Banking Industry Report 2021: Industry Trends, Expansion Technologies, Profiles of Select Cord Blood Banks and Companies -... - January 14th, 2021
- Bone Therapeutics and Rigenerand sign partnership for cell therapy process development - GlobeNewswire - January 14th, 2021
- Europe Prescription Spectacles Market to Exhibit a 5.2% CAGR and Reach USD 31.89 Billion by 2027; Increasing Incidence of Ocular Disorders to Favor... - January 14th, 2021
- Priming the Immune System to Fight Cancer - PRNewswire - December 17th, 2020
- Girl gets her smile back - and a new jaw - thanks to innovative tissue engineering procedure - Newswise - December 17th, 2020
- Bone Regeneration Material Market: Cell-based Segment to Expand Significantly - BioSpace - December 17th, 2020
- Stem Cell Therapy Market is estimated to be worth USD 8.5 Billion by 2030, claims Roots Analysis - Cheshire Media - November 28th, 2020
- Global Regenerative Medicine Market 2020-2025: Opportunities with the Implementation of the 21st Century Cures Act - Stockhouse - November 28th, 2020
- Molecular Diagnostics Market to Record over 7% Growth Rate and Hit USD 13873.6 Million by 2025; Advancements in this Field to Increase Productivity... - November 28th, 2020
- North America Tissue Engineering Market Report 2020: Market is Expected to Reach US$12.23 Billion by 2027 from US$4.45 Billion in 2019 -... - November 22nd, 2020
- Latest Study explores the Stem Cell Banking Market Witness Highest Growth in nea - GroundAlerts.com - November 5th, 2020
- Stem Cell Therapy Market is estimated to be worth USD 8.5 Billion by 2030 - PRnews Leader - November 5th, 2020
- Canine Stem Cell Therapy Market Size, Share Analysis by Manufacturers, Regions, Type and Application to 2026 - PRnews Leader - November 5th, 2020
- Stem Cell Banking Market to witness an impressive growth during the forecast pe - News by aeresearch - November 2nd, 2020
- Global Tooth Regeneration Market: Industry Analysis and Forecast (2020-2027)-by Type, Application, Population Demographics and Region - re:Jerusalem - October 10th, 2020
- The global regenerative medicine market is projected to reach USD 17.9 billion by 2025 from USD 8.5 billion in 2020, at a CAGR of 15.9% - Yahoo... - October 10th, 2020
- The end-use Industries to Help the Tooth Regenerations market stand in a good stead between 2018 and 2026 - The Daily Chronicle - September 18th, 2020
- Increase in Frequency of Product Innovations to Drive the Tooth Regenerations Market from 2018 to 2026 - Lake Shore Gazette - September 15th, 2020
- Incremental Sales to Drive the Tooth Regenerations Market from 2018 to 2026 - Lake Shore Gazette - September 15th, 2020
- Parents plea for stem cell help to save life of daughter with rare blood disorder - Mirror Online - September 2nd, 2020
- Unraveling the use of CBD in veterinary medicine - Jill Lopez - September 2nd, 2020
- Global Stem Cell Banking Market with Covid-19 Effect Analysis, Growth, Research Findings, Type, Application, Element Global Trends and Forecast to... - September 2nd, 2020
- Plasma Therapy Market Overview with Detailed Analysis, Competitive landscape, Forecast to 2025 - StartupNG - September 2nd, 2020
- Active Data Warehousing Market to Witness Robust Expansion Throughout the Forecast Period 2020 2025 - The Daily Chronicle - August 20th, 2020
- 3D bioprinting spatiotemporally defined patterns of growth factors to tightly control tissue regeneration - Science Advances - August 20th, 2020
- NIH names Dr. Rena D'Souza as director of the National Institute of Dental and Craniofacial Research - National Institutes of Health - August 13th, 2020
- Global Cell Theraputics Market Value Estimated To Grow With A Healthy CAGR Rate During 2020-2025: Cell Theraputics Bristol-Myers Squibb Company... - July 10th, 2020
- Global Tissue-Replacement Products Market to Witness Rapid Development During the Period 2017 2025 - Lake Shore Gazette - July 10th, 2020
- Job interviews zoom without leaving the house | What's Working - The Union Leader - July 6th, 2020
- Citius Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute... - June 30th, 2020
- Medical Professionals in the Ozarks - 417mag - June 30th, 2020
- Dental Fitting Market 2019 Break Down by Top Companies, Countries, Applications, Challenges, Opportunities and Forecast 2026 - Cole of Duty - June 10th, 2020
- Coronavirus daily news updates, June 9: What to know today about COVID-19 in the Seattle area, Washington state and the world - Seattle Times - June 10th, 2020
- Metal Fiducial Marks Market Emerging Trends, Strong Application Scope, Size, Status, Analysis and Forecast to 2025 - Cole of Duty - June 10th, 2020
- Impacts of COVID 19 on the Global Regenerative Medicine Market Size: Global Industry Analysis, Growth, Top Companies Revenue, MRFR Reveals Insights... - June 2nd, 2020
- Exceptional stem cell science on tap for ISSCR 2020 Virtual June 23-27, 2020 - 7thSpace Interactive - June 2nd, 2020
- Orthopedic Joint Replacement Market to Gain Traction; Rising Prevalence of Bone Diseases to Boost Growth, states Fortune Business Insights -... - June 2nd, 2020
- Coming Together to Solve COVID-19 Mysteries | University of Pennsylvania Almanac - UPENN Almanac - June 2nd, 2020
- Impact of Covid-19 on Stem Cell Banking Market 2020: Remarking Enormous Growth with Recent Trends | Cord Blood Registry (CBR) Systems (US), Cordlife... - May 27th, 2020
- Researchers develop nanoengineered bioink to 3D print functional bone tissue - 3D Printing Industry - May 27th, 2020
- Directional Osteo-Differentiation Effect of hADSCs on Nanotopographica | IJN - Dove Medical Press - May 8th, 2020
- Bone Therapeutics raises additional EUR 4.0 million, totalling EUR 15 million, providing runway into Q2 2021 - PharmiWeb.com - May 8th, 2020
- Coming together to solve the many scientific mysteries of COVID-19 - Penn: Office of University Communications - May 8th, 2020
- Bone Therapeutics secures EUR 11.0 million financing - PharmiWeb.com - April 30th, 2020
- GLOBAL TOOTH REGENERATION MARKET: INDUSTRY ANALYSIS AND FORECAST (2020-2027) - MR Invasion - April 28th, 2020
- Stromal Vascular Fraction Market to Register CAGR 4.5% Growth in Revenue During the Forecast Period 2019 to 2029 - Jewish Life News - April 28th, 2020
- UCLA scientists invent nanoparticle that could improve treatment for bone defects - UCLA Newsroom - April 27th, 2020
- Orthopedic Devices Market to Reach USD 71.67 Billion by 2026; Increasing Geriatric Population to Boost Growth, says Fortune Business Insights -... - April 10th, 2020
- A new way to study HIV's impact on the brain - Penn: Office of University Communications - March 28th, 2020
- Bone Therapeutics appoints Stefanos Theoharis as Chief Business Officer - OrthoSpineNews - March 28th, 2020
- Walking Sticks Stop, Drop and Clone to Survive - KQED - March 25th, 2020
- Hydrogel could be step forward in therapies to generate bones in head and neck - UCLA Newsroom - March 19th, 2020
- Cell Banking Outsourcing Market to Witness Surge in Demand Owing to Increasing End-use Adoption - Lake Shore Gazette - March 19th, 2020
- New evidence teeth can fill their own cavities - Big Think - March 16th, 2020
- These new stem cells have the ability to generate new bone - Tech Explorist - March 12th, 2020
- Stem cells that can grow new bone discovered by researchers - Drug Target Review - March 6th, 2020
- Stem Cells that will aid new bone generation discovered as per latest research - Medical Herald - March 6th, 2020
- UConn Researchers Discover New Stem Cells That Can Generate New Bone - UConn Today - March 6th, 2020
- What's coming down the pike in the dental profession? - Dentistry IQ - February 26th, 2020
- On the Road to 3-D Printed Organs - The Scientist - February 26th, 2020
- Hyperbaric chamber therapy: Im under a lot of pressure and I love it! - The Guardian - February 26th, 2020