AB Science S.A. (ABSCF)

"Scientists from the University of Chicago have found that the drug masitinib may be effective in treating COVID-19."

"Now, the team is working with the pharmaceutical company that developed masitinib (AB Science) to tweak the drug to make it an even more effective antiviral. Meanwhile, masitinib itself could be taken to human clinical trials in the future to test it as a COVID-19 treatment."

https://www.news-medical.net/news/20210802/Existing-drug-may-be-effective-in-treating-SARS-CoV-2.aspx

AB SCIENCE ANNOUNCES THE SUCCES OF ITS CAPITAL RAISE FOR A TOTAL AMOUNT OF 15.0 MILLION EUROS

·10.5 million euros raised through a private placement and accelerated book-building procedure, without discount, at a price of 14.42 euros per ordinary share.

·This private placement triggers the conversion of the convertible bonds announced on October 29, 2020 with a nominal value of 4.5 million euros.

Paris, France – December 21, 2020
AB Science (the “Company” or “AB Science”, Euronext – FR0010557264 – AB) announces a capital raise of 10.5 million euros by way of issuance of 728,156 new ordinary shares (the “New Shares”). The capital raise was subscribed by European and north American qualified investors (the “Capital Raise”).

AB Science announces the publication of the masitinib positive pivotal Phase 3 trial in progressive forms of multiple sclerosis in the journal Neurology® Neuroimmunology & Neuroinflammation

PUBLICATION OF THE MASITINIB PIVOTAL PHASE 3 CLINICAL TRIAL IN PROGRESSIVE FORMS OF MULTIPLE
SCLEROSIS IN THE JOURNAL NEUROLOGY®: NEUROIMMUNOLOGY & NEUROINFLAMMATION
Paris, 22 February, 2022, 6pm CET

AB Science SA (Euronext - FR0010557264 - AB) today announced publication of results from its positive
pivotal phase 3 trial of masitinib in progressive forms of multiple sclerosis in the peer-reviewed journal
Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of
Neurology [1].

This article, titled ‘Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A
Randomized, Phase 3, Clinical Trial’ is freely accessible online from the journal website:
https://nn.neurology.org/content/nnn/9/3/e1148.full.pdf.

Patrick Vermersch, MD, Professor of Neurology at the University of Lille, France, and senior author of this
article commented: “This publication provides the first clinical evidence that targeting the innate immune
system is an effective strategy for the treatment of progressive forms of MS. More specifically, results showed that masitinib at 4.5 mg/kg/d can benefit patients by slowing EDSS-based disability worsening, including a statistically significant reduction in the risk of requiring a wheelchair, which is a clinically meaningful outcome for patients. Remarkably, the results of study AB07002 demonstrate, for the first time, the efficacy of a therapeutic product in the treatment of MS patients who were progressing but not clinically active, which includes non-active primary progressive and secondary progressive MS. There is currently no approved therapy that encompasses this particular population of progressive MS. I am therefore excited to continuing the development of masitinib in its confirmatory Phase 3 study (AB20009), with the anticipation that it could be a new therapeutic hope for these patients.”

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the
Académie des Sciences in France said, “Masitinib is a truly innovative drug for MS because unlike the majority of drug development research in this indication, masitinib targets mast cells and microglia in the central nervous system. These cells of the innate immune system are increasingly implicated in the pathophysiology of progressive MS [2–4]. Indeed, considering also the successful clinical demonstration of masitinib’s neuroprotective benefits in Alzheimer’s disease [5] and amyotrophic lateral sclerosis (ALS) [6,7], targeting of the innate immune system appears to be a valid general strategy for treatment of neurodegenerative disorders. Masitinib is therefore uniquely positioned to realize this potential therapeutic game changer.”

Study AB07002 met its primary analysis endpoint, demonstrating a statistically significant reduction in
cumulative change on Expanded Disability Status Scale (EDSS) score with masitinib 4.5 mg/kg/d (p=0.0256).
This treatment-effect was consistent for both primary progressive MS (PPMS) and non-active secondary
progressive (nSPMS) patient subgroups. In addition, masitinib significantly reduced the risk of first disability
progression by 42% and reduced the risk of confirmed (3 months) disability progression by 37%. Masitinib
also significantly reduced the risk of reaching an EDSS score of 7.0, corresponding to disability severe enough that the patient is restricted to a wheelchair (p=0.0093). Safety was consistent with masitinib’s known profile, with no elevated risk of infection, which could prove advantageous compared with other MS drugs, many of which are associated with increased risk of infectious complications.

Confirmatory study AB20009 has recently been approved by the French Medicine Agency (ANSM) and also
the Swedish Medical Products Agency. This study will enroll 800 patients from numerous study centers with
EDSS score between 3.0 to 6.0 and absence of T1 Gadolinium-enhancing brain lesions as measured by
magnetic resonance imaging (MRI). The primary objective of the study will be to evaluate the effect of
masitinib on time to confirmed disability progression, with progression defined as 1-point worsening when
EDSS baseline score ≤5.5, or 0.5 if baseline score >5.5 from randomization to week 96.