AB Science situation and future prospects presented during the Combined General Shareholders' Meeting held on July 29 2018
Paris, July 3, 2018, 6.30pm
Results of the June 29, 2018 Combined General Shareholders' Meeting
A Combined General Shareholders' Meeting was held on July 29, 2018 in Paris.
The shareholders present or represented together held 18,861,180 shares, representing respectively 45.39% of the total number of shares and 60.75% of the voting rights.
All resolutions submitted to the vote of the shareholders have been adopted, with the exception of the 24th resolution, which was rejected. The voting details for each resolution are available on the AB Science website (http://www.ab-science.com).
The General Shareholders' Meeting was an opportunity to present the Company's situation and future prospects. This presentation is available on the AB Science website.
- Update on the action plan following the clinical hold in France
AB Science has upgraded its organization, management seniority, processes and tools related to clinical development.
AB Science presented its new organization, notably the appointment of 7 new, highly experienced professionals in order to conduct clinical studies according to best practices.
Among these people is Jean-Pierre Lehner, former Chief Medical Officer of Sanofi, in charge of worldwide medical affairs, global regulatory affairs, and pharmacovigilance. Jean-Pierre Lehner has participated in the registration of more than 30 new drugs and brings his clinical development experience as Scientific Senior Vice President in support of masitinib and the new compounds being developed by AB Science.
This new organization is designed to guarantee strict compliance with Good Clinical Practices.
The Company is in contact with ANSM to evaluate this new organization.
- Update on Amyotrophic Lateral Sclerosis (ALS)
In ALS, the Company decided to wait for the lifting of the clinical hold in France before launching a confirmatory study, in order to eliminate any ambiguity regarding GCP compliance at the start of the study.
Moreover, AB Science intends to launch this study in France and in the US, which requires prior approval in both countries.
Masitinib is recognized by the scientific community as a promising drug in ALS. At the last ENCALS congress held from June 20th to 22nd, the company presented the design of the confirmatory study to the ALS key opinion leaders.
AB Science is currently validating through a scientific advice with EMA the design of the ALS confirmatory phase 3 study.
AB Science reiterated its intention to submit an updated application for the conditional marketing authorization for masitinib in ALS based on the final results from the phase 2/3 study AB10015, subject to the acceptance by EMA.
- Update on other studies
The Company highlighted the following results reported during masitinib clinical development in 2017:
- Two phase 3 studies completed in 2017 their planned enrollment target, in severe asthma uncontrolled by oral corticosteroids and progressive forms of multiple sclerosis.
- Two studies met their primary endpoint in the pre-specified sub-population, the phase 3 study in mastocytosis and the phase 2/3 in ALS.
- The Independent Data Monitoring Committee (IDMC) recommended the continuation of three studies based on interim analysis:
- In severe asthma uncontrolled by oral corticosteroids, without resampling.
- In progressive forms of multiple sclerosis, without resampling in at least one of the tested doses.
- In metastatic prostate cancer, with a total of 468 patients to be enrolled in the pre-specified sub-population.
In these three studies, the interim analysis included a test that either did not trigger an increase of the sample size if this test gave a probability of success of the study above 80%, or triggered an increase of the sample size (up to a doubling of the sample size) to achieve a probability of success of the study above 80%, or triggered the stop of the study in case of low probability of success.
The Company also presented the upcoming clinical milestones. This update follows the Company decision to postpone the analyses of several studies in order to ensure that these analyses are carried out within the new quality system.
The expected clinical milestones are :
- Q3 2018 : Trend analysis for the phase 2/3 study in refractory colorectal cancer
- Q4 2018 :
- Trend analysis for the phase 2/3 study in refractory ovarian cancer
- Interim analysis for phase 3 study in pancreatic cancer
- Interim analysis for phase 2/3 study in Alzheimer's disease
- Final analysis for phase 3 study in severe asthma uncontrolled by oral corticosteroids
And also :
- Launch of confirmatory in ALS and mastocytosis, subject to the lifting of the clinical hold in France
In 2019, the Company expects final analyses for studies in Alzheimer's disease, progressive forms of multiple sclerosis, and 4 oncology indications (prostate cancer, pancreatic cancer, colorectal cancer, ovarian cancer), subject to reaching the required number of events.
The Company also paid tribute to Olivier Hermine, following his appointment to the French Académie des Sciences. Olivier Hermine is a co-founder of AB Science, co-chairman of its scientific committee, and defines the Company strategy in the selection of therapeutic indications and in the selection of new drugs to develop.
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 class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, and inflammatory diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).
Further information is available on AB Science's website: www.ab-science.com.
Forward-looking Statements - AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance.
These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents filed by AB Science with the Autorité des Marchés Financiers (AMF), including those listed in the Chapter 4 "Risk Factors" of AB Science reference document filed with the AMF on November 22, 2016, under the number R. 16-078. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.
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