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Bone Therapeutics SA announces H1 results for 2018
The interim financial report is prepared in accordance with article 13 of the Royal Decree on the obligations of issuers of financial instruments admitted to trading on a regulated market and can be accessed on the website of Bone Therapeutics in the section 'Financial information'.
Bone Therapeutics publishes its interim financial report in English. A French translation of the report will also be made available. In the event of differences between the English and the French version of the report, the original English version will prevail.
Bone Therapeutics announces H1 results for 2018
Patient recruitment completed for Phase I/IIA spinal fusion study with ALLOB®
Strengthening of Company's Board with the appointments of Jean Stéphenne as Chairman, and Claudia D'Augusta and Jean-Luc Vandebroek as new Board members
€ 19.45 million of commitment secured following successful private placement of convertible bonds
Conference call to be held at 12:00 noon CEST / 11:00am BST today -details below
Gosselies, Belgium, 30 August 2018, 7am CEST - BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today provides a business update and its financial results for the six-month period ended 30 June 2018, prepared in accordance with IFRS as adopted by the European Union.
Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: "We have made significant progress over the first half of 2018 towards our goal of creating efficacious and commercially scalable bone cell therapy products to address large underserved patient populations. We have made advances clinically, secured significant depth of experience at the Board level and have the funds to ensure continued pace across our development programmes in the future. Looking to the second half of the year, we look forward to providing further data on our allogeneic and autologous programmes and our further clinical development plans."
Operational and Corporate Highlights
- In February 2018, Bone Therapeutics completed patient recruitment in the ALLOB® Phase IIA spinal fusion study. Efficacy and safety data for the full set of 32 patients are expected mid-2019, post a follow-up period of 12 months.
- The Company appointed Jean Stéphenne as Chairman and Claudia D'Augusta as an independent director to its Board of Directors. Their vast experience in biotech leadership and manufacturing excellence will greatly support the progress of the clinical and commercial development of the Company's promising cell therapy pipeline.
- Following his nomination at the Annual General Assembly held in June 2018, Chief Financial Officer, Jean-Luc Vandebroek also joined the Board as an Executive Director.
- In March, Bone Therapeutics secured via a private placement of convertible bonds and associated bond warrants € 19.45 million in committed capital. The exercise of warrants by part of the investors resulted in total gross proceeds for the period of € 9.09 million, made up of initial gross proceeds of € 6.58 million and the exercise of additional 1,002 bond warrants have been exercised resulting in supplementary proceeds of € 2.51 million in the second quarter. The remaining warrants will be exercised over a maximum period of 16 months ending in October 2019, providing additional proceeds of € 10.36 million. (For additional details regarding the convertible bonds and the impact of the related transactions on the financial statements, we refer to note 5 concerning the Financial Liabilities in the H1 2018 Report.)
- During the first six months of 2018, total operating income amounted to € 1.88 million, a slight decrease compared to the same period in 2017 (€ 1.92 million).
- Operating loss for the period amounted to € 6.08 million, compared to € 6.16 million in H1 2017
- The Company ended the first six months of 2018 with € 9.10 million in cash and cash equivalents. Cash used for the period amounted to € 7.90 million excluding net proceeds obtained from the private placement and exercise of bond warrants, is in line with cash used over the same period last year (€ 7.70 million).
Outlook for the remainder of 2018
- Bone Therapeutics plans to report the final results from the ALLOB® Phase I/IIA delayed-union study, provide an update on the optimisation of its allogeneic manufacturing process and the next steps of clinical development in September.
- The Company expects to present the conclusions of the interim analysis after a one-year follow-up period of the first 44 patients in the Phase III study of PREOB® in osteonecrosis of the hip in Q4 2018.
- The Company confirms the expected cash burn (excluding proceeds from financing) for the full year 2018 to be in the range of € 15-16 million in line with previous guidance. Based on its current priorities, the Company expects to have sufficient cash to carry out its objectives until the end of Q3 2019.
Thomas Lienard, Chief Executive Officer, and Jean-Luc Vandebroek, Chief Financial Officer, will host a conference call and Q&A at 12:00 noon CEST / 11:00am BST. The call will be conducted in English and a replay will be available for 30 days via the Company's website.
To access the conference call, please dial one of the appropriate number below quoting the conference ID.
Belgium: +32 (0)24 00 98 74
France: +33 (0) 176 70 07 94
US: +1 (866) 966 1396
UK: +44 (0) 2071 928 000
Conference ID: 5184256
The presentation will be made available on the Investors section of the Bone Therapeutics website shortly before the call (http://bonetherapeutics.com/en/investors/presentations)
Key opinion leader event
On the morning of the 14 September, the Company will host a Key Opinion Leader Event in Paris at 12.30pm CEST. Presentations will be given by Prof. Dr. Frédéric Dubrana, Orthopaedic Surgeon at the University Hospital of Brest and Professor at the University of Western Brittany and Thomas Lienard, Chief Executive Officer. The event in Paris will be held in French with an English language webcast of the same presentations at 3.30pm CEST. For more information please contact firstname.lastname@example.org.
About Bone Therapeutics
Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.
Bone Therapeutics' technology is based on a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells into "osteoblastic", or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.
The Company's primary clinical focus is ALLOB®, an allogeneic "off-the-shelf" cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient's own bone marrow and currently in Phase III development for osteonecrosis of the hip.
Bone Therapeutics' cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.
Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00
For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
Tel: +44 (0) 20 3709 5701
For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
For US Media and Investor Enquiries
Tel: + 1 443 213 0506
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.