AB Science today reports its revenues for the first half of

         PRESS RELEASE

AB SCIENCE PRESENTS ITS FINANCIAL INFORMATION FOR THE FIRST HALF OF 2022 AND THE KEY EVENTS OF THE PERIOD

• Clinical growth
  • Authorization by Health Canada in February 2022 to file a New Drug Submission for masitinib in the remedy of amyotrophic lateral sclerosis (ALS) beneath the Notice of Compliance with Conditions (NOC/c) coverage and formal begin of the evaluation in May 2022. Health Canada has a goal of 200 calendar days most to evaluation the utility
  • Filing for conditional Marketing Authorization to the European Medicines Agency (EMA) for masitinib in the remedy of amyotrophic lateral sclerosis (ALS) and formal begin of the evaluation in August 2022
  • Launch of a confirmatory Phase 3 examine with masitinib in progressive kinds of a number of sclerosis
  • Positive advice of the Data and Safety Monitoring Board to proceed each Phase 2 research in Covid-19
• Financial data and different company data
  • Operating loss of €9.6 million as of 30 June 2022, a rise of 58% in comparison with the first half of 2021
  • Cash place of €7.6 million as of 30 June 2022, plus the €7.1 million of 2020 and 2021 analysis tax credit score and a financing settlement with the European Investment Bank of which 12.0 million euros can be found at that date

Paris, September 30, 2022, 6.30pm CET

AB Science SA (Euronext – FR0010557264 – AB) today reports its revenues for the first half of 2022 and supplies an replace on its actions.

CLINICAL DEVELOPMENT KEY EVENTS FOR THE FIRST HALF OF 2022 AND SINCE JUNE 30, 2022

Authorization by Health Canada to file a New Drug Submission for masitinib in the remedy of amyotrophic lateral sclerosis (ALS) beneath the Notice of Compliance with Conditions (NOC/c) coverage

AB Science introduced that Health Canada has granted authorization to file a New Drug Submission for masitinib in the remedy of amyotrophic lateral sclerosis (ALS) beneath the Notice of Compliance with Conditions (NOC/c) coverage.

If granted, an NOC/c is authorization to market a drug with situations. Such situations might be mentioned with Health Canada throughout the process.

An evaluation named Advance Consideration, carried out by a Health Canada Adjudicating Committee, is critical earlier than being granted authorization to file beneath NOC/c coverage.

This evaluation was made based mostly on a pre-submission bundle despatched by AB Science together with, efficacy information of examine AB10015, long-term survival information (75 months common follow-up from analysis) of examine AB10015, and security information.

An estimated 3,000 Canadians are at the moment dwelling with ALS. Each yr roughly 1,000 Canadians die from ALS. The same quantity of Canadians are recognized with ALS every year.

Under the NOC/c coverage, Health Canada has a goal of 200 calendar days most to evaluation the utility.

Filing for conditional Marketing Authorization to the European Medicines Agency (EMA) for masitinib in the remedy of amyotrophic lateral sclerosis (ALS)

AB Science filed an utility for conditional Marketing Authorization to the European Medicines Agency (EMA) for Alsitek (masitinib) in the remedy of amyotrophic lateral sclerosis (ALS). The utility relies on outcomes from the part 2/3 AB10015 examine and its long-term survival follow-up. Study AB10015 was a randomized, double-blind, placebo-controlled trial over a 48-week remedy interval, carried out with 394 ALS sufferers and evaluating Alsitek together with riluzole versus riluzole alone.

This choice to file adopted a pre-submission assembly held with the Committee for Medicinal Products for Human Use (CHMP) Rapporteur throughout which new information generated with Alsitek in ALS had been offered, particularly, a scientific profit in phrases of a 25-month improve in median total survival for sufferers with average ALS, which is a cohort that carefully resembles newly recognized sufferers. During the pre-submission assembly, AB Science additionally offered how points listed in the earlier CHMP evaluation for Alsitek on ALS (EMA/406203/2018) had been resolved, particularly:

• The mode of motion of Alsitek in ALS, which has been well-demonstrated and printed in peer-reviewed publications.
• A remonitoring of all efficacy and security information and a whole reassessment of the Alsitek security database.
• Additional analyses for the major efficacy endpoint, imputing all lacking information for early discontinuation, and a conservative evaluation imputing lacking information with a penalty for sufferers who discontinued Alsitek for lack of efficacy or toxicity. These analyses had been constructive, and all confirmed a remedy impact in favor of Alsitek and convergent with the major evaluation.
• Long-term follow-up survival information exhibiting a big profit in favor of Alsitek in average ALS sufferers (between group distinction in median OS of +25 months, hazard ratio 0.56 (95percentCI [0.32;0.96])).

This utility has now been validated by EMA and evaluation by the CHMP has begun. The CHMP has a goal of 210 energetic analysis days to evaluation the utility.

Launch of a confirmatory Phase 3 examine with masitinib in progressive kinds of a number of sclerosis

AB Science introduced that it has been approved by the French Medicine Agency, ANSM, to provoke a Phase III examine (AB20009) evaluating masitinib in sufferers with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS). The examine will enroll 800 sufferers from quite a few examine facilities with Expanded Disability Status Scale (EDSS) rating between 3.0 to six.0 and absence of T1 Gadolinium-enhancing mind lesions as measured by magnetic resonance imaging (MRI).

The major goal of the examine might be to judge the impact of masitinib on time to confirmed incapacity development, with development outlined as 1-point worsening when EDSS baseline rating ≤5.5, or 0.5 if baseline rating >5.5 from randomization to week 96.

This confirmatory examine follows profitable completion of a first Phase 2B/3 examine (AB07002) in major progressive (PPMS) and non-active secondary progressive (nSPMS) a number of sclerosis. This examine met its major evaluation endpoint, demonstrating a statistically vital discount in cumulative change on EDSS with masitinib 4.5 mg/kg/day (p=0.0256).

Positive advice of the Data and Safety Monitoring Board to proceed each Phase 2 research in Covid-19

AB Science introduced the continuation of the Phase 2 examine evaluating masitinib together with isoquercetin in COVID-19, following the advice of the Data and Safety Monitoring Board (DSMB). This randomized (1:1), open-label, part 2 examine (AB20001) is designed to judge the security and efficacy of masitinib plus isoquercetin in hospitalised sufferers with average COVID-19 (WHO 7-point ordinal scale degree 4) or extreme COVID-19 (degree 5). The examine is deliberate to recruit 200 sufferers (over 18 years of age with no higher age restrict). The major goal is to enhance the scientific standing of sufferers after 15 days of remedy, as measured by the WHO 7-point ordinal scale.

The interim evaluation was carried out with one third of the sufferers evaluated, as deliberate. The function of the interim evaluation was to evaluate the security and efficacy of the remedy. The DSMB recommends persevering with the examine with out restrictions in average sufferers (degree 4, i.e. hospitalized sufferers with oxygen provide <6 L/min with SpO2 maintained ≥92%). In line with this advice, AB Science has made the choice to proceed the examine solely in average sufferers. The examine is due to this fact now deliberate to incorporate 200 sufferers at degree 4 of the ordinal scale.

AB Science additionally introduced the continuation of the second Phase 2 examine evaluating the antiviral exercise of masitinib in sufferers who’ve a confirmed analysis of COVID-19, following the advice of the Data and Safety Monitoring Board (DSMB). This randomized (1:1), double-blind, part 2 examine (AB21002) in 78 sufferers, is designed to judge the anti-viral efficacy of masitinib in non-hospitalized sufferers who’re in danger of creating extreme COVID-19 and in hospitalized sufferers with want of oxygen (by way of face masks or nasal cannula).

The evaluation was to evaluate the security of the remedy and was based mostly on the first 50% of the affected person focused recruitment. The DSMB indicated that there was no security concern and beneficial continuation of the examine with out restrictions.

CONSOLIDATED FINANCIAL INFORMATION FOR THE FIRST HALF OF 2022

The working loss as of June 30, 2022 was 9,562 Ok€, in comparison with a loss of 6,040 Ok€ as of June 30, 2021, i.e. a rise in the working loss of 3,522 Ok€ (58.3%).

• Operating revenue, solely made up of gross sales associated to the operation of a veterinary medication, amounted to 629 Ok€ as of June 30, 2022 in comparison with 818 Ok€ one yr earlier
• Operating bills amounted to 10,192 Ok€ as of June 30, 2022, in comparison with 6,858 Ok€ as of June 30, 2021, a rise of 48.6%.
• Marketing bills elevated by 7.2% from 236 Ok€ as of June 30, 2021 to 253 Ok€ as of June 30, 2022.
• Administrative bills elevated by 26.9%, from 1,326 Ok€ as of June 30, 2021 to 1,682 Ok€ as of June 30, 2022.
• Research and growth bills elevated by 2,800 Ok€, i.e 52.8 %, from 5,299 Ok€ as of June 30, 2021 to eight,099 Ok€ as of June 30, 2022. This variation is principally defined by:
  • the lower in the analysis tax credit score (600 Ok€), as a result of the finish of the doubling of subcontracting bills to public analysis laboratories in the calculation of the analysis tax credit score base from 2022,
  • the recognition at 30 June 2021 of revenue associated to the cancellation of previous accounts payable (860 Ok€), and
  • the recognition on 30 June 2022 of the valuation of warrants (414 Ok€)

The monetary revenue as of June 30, 2022 is a acquire of 2,424 Ok€ in comparison with a loss of 1,386 Ok€ one yr earlier. The acquire of 2,424 Ok€ as of 30 June 2022 is principally associated to the recognition of the change in truthful worth between 31 December 2021 and 30 June 2022 of the desire shares ensuing from the conversion of the bonds in December 2016 (class C) and of the desire shares issued in September 2020 (class D), i.e. a monetary acquire of 2,244 Ok€ with no influence on money over the interval.

The internet loss as of June 30, 2022 quantities to 7,141 Ok€ in comparison with a loss of 4,655 Ok€ as of June 30, 2021.

The following desk summarizes the consolidated monetary statements for the first half of 2022 ready in accordance with IFRS, and comparative data with the first half of 2021:

OTHER CORPORATE INFORMATION FOR THE FIRST HALF OF 2022 AND SINCE JUNE 30, 2022

Financing of USD 8.5 million by way of the issuance of bonds with connected warrants

AB Science reached an settlement with a historic investor on a financing of USD 8.5 million by way of the issuance of bonds convertible into new atypical shares with connected warrants (OCABSA).

50,000 OCABSA might be issued, representing a nominal worth of USD 8.5 million. It will reinforce the money place of AB Science for the growth of its scientific analysis program.

50,000 convertible bonds might be issued at their par worth of USD 170,0 every (the “PV”), representing a complete par worth of USD 8.5 million.

Decision of the Enforcement Committee of the French market regulator (AMF) following the investigation referring to the monetary data and the market for AB Science shares, opened in September 2017

On March 24, 2022, the AMF Enforcement Committee dominated that there was no privileged data, neither at the time of the two capital will increase carried out by AB Science on March 24 and 27, 2017, nor at the time Alain Moussy bought a component of his shares on March 31, 2017. The AMF Enforcement Committee due to this fact fully exonerated Alain Moussy, prosecuted for insider buying and selling, and located that AB Science had not did not adjust to its disclosure obligations at the time of these capital will increase in March 2017.

The AMF Enforcement Committee nonetheless thought-about that AB Science ought to have communicated as early as April 7, 2017 the excessive likelihood of a unfavourable opinion from the European Medicine Agency (EMA) on the advertising and marketing authorization utility for masitinib for the remedy of mastocytosis and ordered AB Science to pay the sum of a million euros.

In utility of its inside procedures, AB Science had nonetheless put in place a deferral of privileged data from this date of April 7, 2017, contemplating that the delay in communication was in the curiosity of the Company and in keeping with business practices of not speaking earlier than the remaining vote of the CHMP, or else withdrawing the registration file, which AB Science had no intention to do.

Given this distinction in evaluation regarding a technical level relating to 1 of the standards for the deferred communication of privileged data, in addition to the quantity of penalty, AB Science has determined to attraction to the Paris Court of Appeal. The President of AMF additionally appealed in opposition to the Enforcement Committee’s choice.

Other occasions

• Considerations arising from the Russia-Ukraine conflict

Russia launched invasion of Ukraine in February 2022, which, alongside humanitarian considerations, may have an effect on the well being analysis ecosystem in the type of delays in the conduct of scientific trials. At the date of publication of the December 31, 2021 annual report, there have been no vital delays or impacts on the research monitored in Russia and Ukraine.

• Other securities transactions

During the first half of 2022, 56,990 share subscription warrants and 5,000 stock-options had been granted.

AB Science confirms its eligibility for PEA-PME (a share financial savings plan aimed toward offering finance to SMEs) in accordance with decree no. 2014-283 of 4 March 2014 taken for the utility of article 70 of regulation no. 2013-1278 of 29 December 2013 of finance for 2014 fixing the eligibility of firms for PEA-PME, i.e. lower than 5,000 workers on the one hand, an annual turnover of lower than 1,500 million euros or a complete stability sheet of lower than 2,000 million euros, on the different hand.

About AB Science
Founded in 2001, AB Science is a pharmaceutical firm specializing in the analysis, growth and commercialization of protein kinase inhibitors (PKIs), a category of focused proteins whose motion are key in signaling pathways inside cells. Our packages goal solely ailments with excessive unmet medical wants, typically deadly with quick time period survival or uncommon or refractory to earlier line of remedy.
AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medication and is developed in human medication in oncology, neurological ailments, inflammatory ailments and viral ailments. The firm is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).

Further data is offered on AB Science’s web site:
www.ab-science.com.

Forward-looking Statements – AB Science
This press launch incorporates forward-looking statements. These statements will not be historic details. These statements embrace projections and estimates in addition to the assumptions on which they’re based mostly, statements based mostly on tasks, aims, intentions and expectations relating to monetary outcomes, occasions, operations, future providers, product growth and their potential or future efficiency.

These forward-looking statements can typically be recognized by the phrases “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan” in addition to different comparable phrases. While AB Science believes these forward-looking statements are cheap, traders are cautioned that these forward-looking statements are topic to quite a few dangers and uncertainties which can be tough to foretell and usually past the management of AB Science and which can suggest that outcomes and precise occasions considerably differ from these expressed, induced or anticipated in the forward-looking data and statements. These dangers and uncertainties embrace the uncertainties associated to product growth of the Company which might not be profitable or to the advertising and marketing authorizations granted by competent authorities or, extra typically, any components that will have an effect on advertising and marketing capability of the merchandise developed by AB Science, in addition to these developed or recognized in the public paperwork printed by AB Science. AB Science disclaims any obligation or endeavor to replace the forward-looking data and statements, topic to the relevant laws, particularly articles 223-1 et seq. of the AMF General Regulations.

For further data, please contact:

AB Science
Financial Communication & Media Relations
[email protected]

• AB SCIENCE press launch S1 2022 VEng VF