GOSSELIES, Belgium--(BUSINESS WIRE)--Regulatory News:
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 (Brussels:BOTHE) (Paris:BOTHE) (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in bone fracture repair, fracture prevention and spinal fusion, today provides a business update and its financial results for the six-month period ended 30 June 2016, prepared in accordance with IFRS as adopted by the European Union.
Enrico Bastianelli, Chief Executive Officer of Bone Therapeutics, commented: “Over the past six months we have made significant progress across our pipeline, with important safety and efficacy results from the ongoing Phase II programs in delayed-union fractures, spinal fusion and osteoporosis and the final results of the Phase IIB osteonecrosis study, underpinning confidence in our platforms.
“Following the promising results of the first patient group in the PREOB® Phase IIA severe osteoporosis trial, we made the important strategic decision to transition the osteoporosis program to allogeneic development. This reflects our belief that ALLOB® has the potential to deliver a better solution for patients and enhance the value of this programme from a future partnership.
“In the second half of 2016, we look forward to communicating efficacy results from the ALLOB® spinal fusion trial and completing recruitment for the interim analysis in the Phase I/IIA delayed-union trial.”
In the first half of 2016, the Company made important progress across its pipeline:
- Positive effects on pain and osteoporosis blood markers after a single intravenous administration of PREOB® in the first patient cohort in the Phase IIA severe osteoporosis trial.
- The strategic decision was made to transition the program for severe osteoporosis to allogeneic development. The initiation of a controlled Phase IIB study with ALLOB® is currently being prepared.
- Presentation of positive 12-month efficacy results of the first patient in the ALLOB® Phase IIA spinal fusion trial at the Clinical Applications of Stem Cells conference.
- Completion of recruitment for the ALLOB® Phase IIA spinal fusion trial without any treatment-related safety concerns, with extension of the study due to high clinical demand and to investigate the detailed dynamics of the fusion.
Impaired fracture healing:
- Primary endpoints met in seven out of eight patients in the Phase I/IIA ALLOB® delayed-union trial, with overall 77% radiological and 68% clinical improvement six months after treatment.
- Expansion of the delayed-union program with ALLOB® into multiple fractures. Twelve patients, diagnosed with multiple delayed-union fractures of long bones, will be enrolled into the study.
- Demonstration of superiority of a single PREOB® administration over standard of care in Phase IIB osteonecrosis study. Data presented at EULAR in June showed that at 24 months, 70% of PREOB®-treated patients responded to treatment, compared to only 37% of patients in the standard of care group.
The Company further strengthened its ability to deliver its growth strategy with the appointment of Benoît Champluvier as Chief Technology and Manufacturing Officer. Mr Champluvier joins from GlaxoSmithKline Vaccines, where he has more than 20 years’ experience of driving innovative and complex bioprocesses, supporting the development and launch of a number of new products. He will be responsible for production and quality control, playing a key role in gearing up Bone Therapeutics’ capacity to manufacture both commercial-scale and clinical trial batches at its specialist facility in Gosselies. Mr Champluvier’s nomination follows the appointment of Thomas Lienard as Chief Business Officer in November 2015 with responsibility for business development, business operations and strategic planning.
Bone Therapeutics celebrated its 10-year anniversary together with guests from the industry and the government, as well as from the international scientific community. Strong testimonials were given by representatives from the medical community involved in Bone Therapeutics’ clinical programs: Click here to view the videos.
- During the first six months of 2016, the operating income amounted to EUR 1.95 million, in line with revenues realized during the first half of 2015 (EUR 1.98 million).
- The operating loss for the period amounted to EUR 5.74 million, compared with EUR 5.36 million in H1 2015.
- The Company ended the first six months of 2016 with EUR 26.60 million in cash and cash equivalents. Cash burn for the period amounted to EUR 7.01 million, in line with cash used over the same period last year excluding the revenues and expenses related to the IPO.
Outlook for the remainder of 2016
In the second half of 2016, Bone Therapeutics will continue its promising Phase II proof-of-concept trials with ALLOB® and plans to communicate important efficacy results of the spinal fusion trial. The Company also expects to complete recruitment for the interim analysis in the Phase I/IIA delayed-union trial. The outcome of this interim analysis, expected in Q2 2017, will determine whether the trial can be stopped at this point and already proceed towards the next phase of development.
An important focus in the second half of 2016 will be the preparation of Bone Therapeutics’ first US clinical trial.
Careful cash management will remain a key priority for the Company, with a strong focus on net cash burn. The Company has sufficient cash to carry out its strategic objectives until early 2018. Cash burn for the full year 2016 is expected to be in order of EUR 14.5-16.0 million.
About Bone Therapeutics
Bone Therapeutics is a leading biotechnology company specializing in the development of cell therapy products intended for bone fracture repair and fracture prevention. The current standard of care in this field involves major surgeries and long recovery periods. To overcome these problems, Bone Therapeutics is developing a range of innovative regenerative products containing osteoblastic/bone-forming cells, administrable via a minimally invasive percutaneous technique; a unique proposition in the market.
PREOB®, Bone Therapeutics’ autologous bone cell product, is currently in pivotal Phase IIB/III clinical studies for two indications: osteonecrosis and non-union fractures, and in Phase II for severe osteoporosis. ALLOB®, its allogeneic “off-the-shelf” bone cell product, is in Phase II for the treatment of delayed-union fractures and lumbar fusion for degenerative disease of the spine, including a minimally invasive therapy for failed spinal fusions. The Company also runs preclinical research programs and develops novel product candidates.
Founded in 2006, Bone Therapeutics is headquartered in Gosselies (South of Brussels, Belgium). Bone Therapeutics’ regenerative products are manufactured to the highest GMP standards and are protected by a rich IP estate covering 11 patent families. Further information is available at: www.bonetherapeutics.com.
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.
Consolidated Statement of Comprehensive Income
|(in thousands of euros)||
For the six-month period ended June 30,
|Other operating income||1,953||1,984|
|Total operating income||1,953||1,984|
|Research and development expenses||(6,014)||(5,271)|
|General and administrative expenses||(1,681)||(2,071)|
|Share of profit/(loss) of associates||1||5|
|Result Profit/(loss) before taxes||(5,870)||(7,122)|
|PROFIT/(LOSS) FOR THE PERIOD||(5,809)||(7,122)|
|TOTAL COMPREHENSIVE INCOME OF THE PERIOD||(5,809)||(7,122)|
|Basic and diluted loss per share (in euros)||(0.85)||(1.07)|
|Profit/(loss) for the period attributable to the owners of the Company||(5,638)||(7,051)|
|Profit/(loss) for the period attributable to the non-controlling interests||(171)||(71)|
|Total comprehensive income for the period attributable to the owners of the Company||(5,638)||(7,051)|
|Total comprehensive income for the period attributable to the non-controlling interests||(171)||(71)|
Consolidated Balance Sheet
|Property, plant and equipment||6,320||5,793|
|Investments in associates||283||282|
|Deferred tax assets||2,639||2,333|
|Trade and other receivables||7,038||7,912|
|Other current assets||167||178|
|Cash and cash equivalents||26,604||33,611|
EQUITY AND LIABILITIES
(in thousands of euros)
|Equity attributable to owners of the parent||22,415||28,147|
|Deferred tax liabilities||0||0|
|Other non-current liabilities||1,612||1,575|
|Trade and other payables||2,251||2,579|
|Other current liabilities||4,206||5,590|
|TOTAL EQUITY AND LIABILITIES||43,384||50,383|
Consolidated Cash Flow Statement
(in thousands of euros)
For the six-month period ended June 30,
|CASH FLOW FROM OPERATING ACTIVITIES|
|Depreciation, Amortisation and Impairments||282||163|
|Grants income related to recoverable cash advances||(1,218)||(1,279)|
|Grants income related to patents||(36)||(83)|
|Grants income related to tax credit||(306)||(299)|
|Movements in working capital:|
|Trade and other receivables (excluding government grants)||222||(422)|
|Trade and Other Payables||(384)||(1,156)|
|Cash generated from operations||(7,117)||(8,158)|
|Cash received from grants related to recoverable cash advances||438||32|
|Cash received from grants related to patents||59||12|
|Cash received from grant tax credit||37||0|
|Net cash used in operating activities||(6,583)||(8,114)|
|CASH FLOW FROM INVESTING ACTIVITIES|
|Purchases of property, plant and equipment||(786)||(996)|
|Purchases of intangible assets||(17)||(7)|
|Payments to acquire financial investments||(0)||(1)|
|Net cash used in investing activities||(782)||(978)|
|CASH FLOW FROM FINANCING ACTIVITIES|
|Proceeds from government loans||188||14|
|Repayment of government loans||(402)||(250)|
|Proceeds from loans from related parties||300||0|
|Reimbursements of financial lease liabilities||(116)||(20)|
|Proceeds from other financial loans||476||491|
|Proceeds from issue of equity instruments of the Company (net of issue costs)||0||34,622|
|New financial lease liabilities||98||0|
|Net cash provided by financing activities||358||34,737|
|NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS||(7,007)||25,646|
|CASH AND CASH EQUIVALENTS at beginning of period||33,611||11,577|
|CASH AND CASH EQUIVALENTS at end of period||26,604||37,222|
Consolidated Statement of Changes in Equity
|Attributable to owners of the parent||
|(in thousands of euros)||Share capital||Share premium||Retained earnings||
Total equity attributable
|Balance at 1 January 2015||10,466||1,671||(21,622)||(9,486)||0||(9,485)|
|Total comprehensive income of the period||0||0||(7,051)||(7,051)||(70)||(7,121)|
|Issue of share capital||6,990||30,390||0||37,380||0||37,380|
|Transaction costs for equity issue||0||(2,788)||0||(2,788)||0||(2,788)|
|Conversion of convertible bonds||3,253||13,397||0||16,650||0||16,650|
|Movement non-controlling interests||0||0||(70)||(70)||70||0|
|Balance at 30 June 2015||20,708||42,670||(28,497)||34,879||0||34,882|
|Balance at 1 January 2016||20,708||42,670||(35,232)||28,146||0||28,146|
|Total comprehensive income of the period||0||0||(5,638)||(5,638)||(171)||(5,809)|
|Issue of share capital||0||0||0||0||0||0|
|Transaction costs for equity issue||0||0||0||0||0||0|
|Movement non-controlling interests||0||0||(171)||(171)||171||0|
|Balance at 30 June 2016||20,708||42,670||(40,964)||22,415||0||22,415|