AB SCIENCE Paris, 15 October 2014, 5.45 pm
Quarterly information - 3rd quarter 2014
Turnover up 20% compared to 2013 3rd quarter
Turnover of 1,555K€ as of 30 September 2014
Cash position of 19.1M€ as of 30 September 2014, plus 4.7M€ of 2013 research tax credit
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors (PKIs), today reports its revenues for the 3rd quarter of 2014 and provides an update on its activities.
I.Net sales for the third quarter 2014
The turnover of AB Science group stands at 532 K€ in the third quarter 2014, against 442 K€ in the third quarter 2013, up 20%. The turnover of the group amounted to 1,555 K € as of 30 September 2014, against 1,437 K€ the previous year, representing a growth of 8%.
This revenue is derived from the commercial exploitation of Masitinib in veterinary medicine in EU and USA mainly.
II. Update on the financial position as of 30 September 2014
AB Science cash amounted to 19.1 M€ as of 30 September 2014, excluding reimbursement of research tax credits in 2013 of 4,716 K€, against 24.8 M€ as of 30 June 2014.
III. Key events for the first half of 2014
- On 28 July 2014, AB Science published in the peer-reviewed journal Annals of Oncology, results from a randomized phase 2 study of masitinib in treatment of Gleevec®-resistant gastrointestinal stromal tumor.
This is the publication of the results of the clinical phase 2 study that has supported the application for conditional approval of Masitinib to the European Medicines Agency.
(http://annonc.oxfordjournals.org/lookup/doi/10.1093/annonc/mdu237:
http://annonc.oxfordjournals.org/lookup/doi/10.1093/annonc/mdu237)
Findings showed masitinib to produce a statistically significant overall survival (OS) advantage of 12.4 months in patients with Gleevec®-resistant GIST when compared with Sutent (sunitinib) from Pfizer, which is currently the standard of care for second-line treatment of advanced GIST.
Overall, encouraging survival and safety data from a controlled, randomized trial indicate a positive benefit-risk balance.
An international phase 3 trial of masitinib in patients with Gleevec-resistant/intolerant GIST has been initiated based on these promising results.
- On 30 July 2014, AB Science announced the renewal of its Standby Equity Facility (PACEO®) with Société Générale as authorized by the Shareholders' Meeting of June 27, 2014.
Société Générale has committed to purchase newly created shares at any time during the 36-month commitment period, within the global limit of 3,200,000 shares, being 9.7% of the 32,925,187 shares currently outstanding.
Should the entire standby equity facility be drawn down and resulting in the issuance of 3,200,000 new shares, a shareholder who currently owns 1% of the company's share capital would experience a reduction of his / her ownership to 0.96%[1]:
#_ftn1.
For each tranche, the price to be paid equals the volume weighted average share price of the three trading days preceding the effective date of purchase with a discount capped at 5% dependent on the size of the drawdown. This discount allows Société Générale, who is not positioned as a long term shareholder in the Company, to purchase the shares independently of market volatility.
AB Science has no minimum drawdown obligation, and will use the facility at its sole discretion if market conditions are favorable and in the best interests of both the Company and its shareholders.
- On 30 September 2014, the external Data and Safety Monitoring Board (DSMB) has recommended the continuation of its phase 3 study of masitinib in mastocytosis based upon review of the latest safety and efficacy data. The DSMB was created as part of the Company's pivotal clinical study evaluating masitinib in the treatment of mastocytosis.
This new recommendation corroborates the previous DSMB recommendation to continue this phase 3 study based upon the favorable result of a futility analysis in November 2013. That analysis tested the possibility of masitinib to demonstrate superiority over placebo on the primary analysis as defined in the study protocol.
The objective is this phase 3 study is to compare the safety and efficacy of masitinib with that of placebo in adult patients having smoldering or indolent systemic mastocytosis with severe handicaps/symptoms at baseline.
The final analysis of trial data is still planned for 2015.
Mastocytosis is an orphan disease characterized by an abnormal proliferation of mast cells either in bone marrow only or in several tissues. Mastocytosis comes in two main forms: indolent and aggressive. Indolent mastocytosis can be either cutaneous or systemic. The prevalence of Indolent Systemic Mastocytosis (ISM) is estimated at between 1/40,000 and 1/20,000[2]:
#_ftn2 of the general population. The symptoms and handicaps are severe in about one third of the patients, hence an estimated target population for masitinib ranging from 1/120,000 to 1/60,000 of the general population.
Since the prevalence of Indolent Systemic Mastocytosis is reputed to be comparable across countries, the target population for masitinib could reach an estimated 20,000 adult patients in the world annually.
There is currently no registered treatment in severe systemic mastocytosis.
Masitinib received orphan drug status designation in mastocytosis, both at EMA and FDA.
- Finally, on 6 October, the external Data and Safety Monitoring Board (DSMB) - which was created as part of the Company's pivotal clinical study evaluating masitinib in the treatment of multiple sclerosis - has recommended the continuation of its phase 3 study of masitinib in primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis based upon review of the latest safety data.
The on-going phase 3 clinical trial is an international, multicenter, randomized, double-blind study comparing the efficacy and safety of masitinib with that of placebo in the treatment of patients with progressive forms of multiple sclerosis. The efficacy analysis is measured by Multiple Sclerosis Functional Composite (MSFC) score, EDSS and quality of life after 96 weeks of treatment.
These results are reassuring because they confirm there are no observed safety concerns with masitinib over a 2-year treatment period.
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a new class of targeted molecules whose action is to modify signaling pathways within cells. Through these PKIs, the Company targets diseases with high unmet medical needs (cancer, inflammatory diseases, and central nervous system diseases), in both human and veterinary medicines.
AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine in Europe and in the USA, and is pursuing thirteen phase 3 studies in human medicine in first-line and second-line GIST, metastatic melanoma expressing JM mutation of c-Kit, multiple myeloma, metastatic colorectal cancer, metastatic prostate cancer, pancreatic cancer, mastocytosis, severe persistent asthma, rheumatoid arthritis, Alzheimer's disease, progressive forms of multiple sclerosis, and Amyotrophic Lateral Sclerosis. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).
Further information is available on AB Science website: www.ab-science.com:
http://www.ab-science.com.
This document contains prospective information. No guarantee can be given as for the realization of these forecasts, which are subject to those risks described in documents deposited by the Company to the Authority of the financial markets, including trends of the economic conjuncture, the financial markets and the markets on which AB Science is present.
* * *
AB Science - Financial Communication & Media Relations
investors@ab-science.com:
mailto:investors@ab-science.com
[1]:
#_ftnref1 Based on 32,925,187 shares representing AB Science share capital
[2]:
#_ftnref2 http://www.orpha.net:
http://www.orpha.net (Indolent systemic mastocytosis)
http://hugin.info/155655/R/1863295/653832.pdf
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: AB Science via Globenewswire
