GlobeNewswire Inc | Sep 30, 2020 11:57AM EDT

September 30, 2020

Paris, September 30, 2020, 6pm

Net loss of 8,8M in the first half of 2020, a decrease of 32,4%as compared with the first half of 2019

Cash position of 10.6M as of 30 June 2020, plus 4.1M of 2019 tax creditto be reimbursed by the Public Finance Department

Cash burn amounts to 8,1M for the first half of 2020, as compared with 11.2M for the first half of 2019 (-27%)

AB Science SA (NYSE Euronext - FR0010557264 - AB) today reports its revenues for the first half of 2020 and provides an update on its activities.

I. Key events for the first half of 2020

Clinical studies

Progressive forms of multiple sclerosis

The phase 2B/3 study (AB07002) evaluating oral masitinib in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis met its primary endpoint, demonstrating a statistically significant reduction in disability progression on EDSS with masitinib 4.5 mg/kg/day (p=0.0256). This treatment-effect was consistent for PPMS and nSPMS.

The primary endpoint was absolute change from baseline on Expanded Disability Status Scale (EDSS) averaged for 8 time points measured every 12 weeks over 2 years, with a sensitivity analysis based on the ordinal EDSS change (i.e. +1 if improvement; 0 if stable; -1 if worsening).

The sensitivity analysis based on ordinal EDSS change showed a significant 39% increased probability of having either more disease improvements or fewer disease progressions with masitinib treatment (p=0.0446). In addition, masitinib significantly reduced the risk of first disability progression by 42% and 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 the known tolerability profile for masitinib.

There are two main forms of multiple sclerosis (MS), relapsing remitting (RRMS) and progressive (PMS). While significant progress has been made in the relapsing form of MS, with more than 15 approved drugs, there is still a very high unmet medical need for treating patients with primary progressive MS (PPMS) and non-active secondary progressive MS (nSPMS), with no approved drugs for nSPMS and only one for PPMS. PPMS and nSPMS account for 50% of all MS patients.

Severe asthma

The phase 3 study (AB07105) evaluating oral masitinib in severe asthma uncontrolled by oral corticosteroids met its primary endpoint.The pre-specified primary analysis was conducted in the severe asthma population with daily OCS 7.5 mg and masitinib treatment was associated with a significant reduction in severe asthma exacerbations (p=0.0103).

AB Science presented the results from its phase 3 AB07015 study in severe asthma uncontrolled by oral corticosteroids, at the European Academy of Allergy & Clinical Immunology (EAACI) 2020 Congress, which was held in June 2020. EAACI is one of the most prestigious academic meetings for pulmonary medicine and the worlds largest congress specializing in the field of allergy and clinical immunology.

Covid-19

AB Science was granted authorization by French Medicine Agency (ANSM) to initiate Phase 2 study evaluating masitinib in combination with isoquercetin for the treatment of COVID-19.

This study (AB20001) is a randomized (1:1), open-label Phase 2 clinical trial to evaluate the safety and efficacy of masitinib combined with isoquercetin in hospitalized patients with moderate and severe COVID-19.

The study will enroll 200 patients (age 18 without an upper age limit) at medical centers in France and other countries. The primary objective is to improve the clinical status of patients after 15 days of treatment.

Many patients with moderate and severe COVID-19, develop a cytokine storm that leads to severe pulmonary inflammation and various thrombotic events associated with acute respiratory distress syndrome (ARDS) and potentially death. The combination of masitinib and isoquercetin may prevent the development of these two complications.

-- Masitinib is a potent blocker of mast cells and macrophages that are contributors to the cytokine storm -- Isoquercetin inhibits disulfide isomerase (PDI), an enzyme directly involved in the formation of clots and decreases D-Dimer, a predictor of COVID-19 thrombosis severity. -- The combination of masitinib and isoquercetin has a synergistic effect against senescent cells, a potential target of the virus that could explain the higher mortality rates in the elderly.

-- Prostate cancer

The U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to conduct its masitinib Phase 3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy.

Study AB12003 is an international, multicenter, randomized, double blind, placebo-controlled, 2-parallel group, Phase 3 study in metastatic castrate resistant prostate cancer (mCRPC) eligible to chemotherapy. The study aims to compare the efficacy and safety of masitinib (6.0 mg/kg/day) in combination with docetaxel to placebo in combination with docetaxel. Docetaxel is combined with prednisone.

The study primary endpoint is progression free survival (PFS). A total of 468 patients are planned to be enrolled.

The target patient population consists of adult males who have progressed to develop metastatic castrate resistant prostate cancer (mCRPC) after castration treatment (i.e. reduction of available androgen/testosterone/DHT by chemical or surgical means) and are therefore eligible for chemotherapy.

Other events

Fund raising

In March 2020, AB Science raised 12.3 million euros in funds due to the success of a private placement, the exercise of share warrants and the implementation of a financing option aimed at using the 2019 research tax credit in advance:

-- EUR 6.40 million was raised through a private placement of 860,220 new common shares at a price of EUR 7.44, representing a premium of 5.5% on the closing price -- EUR 1.23 million were raised through the exercise of 449,014 share warrants (subscribed as part of the private placement of August 2019) -- EUR 4.70 million were raised through the implementation of the financing option aimed at using the 2019 research tax credit in advance

The proceeds from all of these transactions will be used by AB Science for general purposes and to finance its clinical development program.

Other transactions on securities:

During the first semester of 2020, 65,000 stock options were allotted.

Other information

AB Science confirms its eligibility for the PEA-SMEs in accordance with decree n2014-283 of 4 March 2014 for the implementation of Article 70 of 2014 Finance Law n2013-1278 of 29 December 2013, setting the PEA-PME eligibility for companies: less than 5 000 employees on one hand, a turnover lower than 1,500 million euros or total assets of less than 2,000 million, on the other hand.

II. Recent events since half-year closing

Presentation of the positive results of the Phase 2B/3 AB07002 study in progressive forms of multiple sclerosis at the 8th Joint ACTRIMS-ECTRIMS meeting

The positive results of the Phase 2B/3 AB07002 study in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis have been presented during the 8th Joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) - European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Meeting, which took place September 11-13, 2020.

The Joint ECTRIMS-ACTRIMS Meeting is the worlds largest international conference devoted to basic and clinical research in multiple sclerosis. This meeting regularly attracts up to 10,000 participants from across the globe and is well-attended by key opinion leaders and decision-makers in MS research and healthcare policy.

Due to the current COVID-19 pandemic, the 2020 Joint ACTRIMS-ECTRIMS Meeting moved to a virtual format this year MSVirtual2020.

Presentation of the positive results of the Phase 2B/3 AB07015 study in severe asthma uncontrolled by oral corticosteroids at the annual 30th European Respiratory Society International Congress

Positive results of the Phase 2B/3 AB07015 study on severe asthma uncontrolled by oral corticosteroids, has been presented at the 30th annual European Respiratory Society (ERS) International Congress which took place September 07-09, 2020. The ALERT session is intended to showcase important clinical trial data from the most ground-breaking randomized clinical trial (RCT) submissions.

The annual European Respiratory Society (ERS) International Congress is the largest meeting in the respiratory field, which in previous years has welcomed over 20,000 delegates from around the world, and is renowned as a showcase of excellence across the entire field of respiratory medicine. The 30th anniversary of the ERS Congress has benn an innovative and interactive virtual event.

Publication of preclinical study results with mastinib in COVID-19

Research led by scientists from the University of Chicago has been posted on the bioRxiv preprint service as an article entitled, Drug repurposing screen identifies masitinib as a 3CLpro inhibitor that blocks replication of SARS-CoV-2 in vitro.

This article reports results of an independent study led by Professor Savas Tay from the Pritzker School for Molecular Engineering (University of Chicago, USA). Starting from a library of 1,900 clinically used drugs, either approved for human use or in late stage clinical development, masitinib stood-out in its ability to completely inhibit activity of the SARS-CoV-2 main protease (3CLpro), thereby blocking viral replication. Remarkably, the research team elucidated masitinibs mechanism of action against SARS-CoV-2, showing that masitinib inhibits 3CLpro, SARS-CoV-2 protease that is crucial for virus infection and reproduction, by directly binding to the protease catalytic site.

Renegotiation of the terms and conditions of the category C preferred shares

The terms and conditions of the 525,406 category C preferred stock, issued in December 2016 upon conversion of bonds, are detailed in the articles of AB Science. In accordance with these terms and conditions, the 525,406 category C preferred stock were to be converted, on 1 September 2020, into a number of common shares equal to the result of the following formula: [12,362,768 / 9.17] 9.17 euros corresponding to the volume-weighted average of the AB Science share price between June 1 and June 30, 2020.

Since AB Science does not have the reserves, profits and premiums necessary to issue, on 1 September 2020, common shares upon conversion of category C preferred stock, discussions have been held between AB Science and the holders of category C preferred stock during the summer of 2020. These discussions resulted in an agreement consisting in the revision of the terms and conditions of the category C preferred stock in order to allow the conversion of these category C preferred stock in several tranches, until December 2021. For each of the tranches, the number of common shares to be issued upon conversion of the category C preferred stock will be calculated on the basis of the highest value between (i) the volume-weighted average of the AB Science share price for the previous month and (ii) the volume-weighted average of the AB Science share price for the previous three months.

In accordance with this agreement, AB Science has undertaken to issue, for the benefit of the holders of class C preferred stock, 30,000 share warrants giving the right to subscribe until the end of 2030, to 30,000 common shares in return for the payment of an exercise price of 12.65 euros per common share.

An Extraordinary General Meeting will be convened during the month of December 2020 in order to ratify and implement the agreement concluded between AB Science and the holders of category C preferred stock during the summer of 2020.

The terms and conditions of other transferable securities issued in December 2016 for the benefit of holders of category C preferred stock (i.e. so-called Nominal share warrants, so-calledConversion share warrants and so-called Capitalised share warrants) are not subject to any revision.

Issue and subscription of 6 million category D3 preferred shares

The combined General Meeting of shareholders of 31 August 2020 decided, under the terms of its eighteenth resolution, to amend the articles of association of AB Science in order to introduce the terms and conditions of the category D3 preferred stock. Pursuant to its twenty-first resolution, the combined General Meeting of shareholders of 31 August 2020 delegated its authority to the Board of Directors with a view to issuing a maximum of 6 million category D3 preferred stock for the benefit of the category of corporate officers or employees of the Company.

On 1 September 2020, the Board of Directors met and decided, upon delegation of the twenty-first resolution of the combined General Meeting of 31 August 2020, to issue 5.8 million category D3 preferred stock for the benefit of Alain Moussy and 200,000 category D3 preferred stock for the benefit of Laurent Guy, Alain Moussy and Laurent Guy falling within the scope of the category of persons defined by the combined General Meeting of shareholders of 31 August 2020 under its twenty-first resolution. In accordance with the calculation formula established by first rank valuers and adopted under the twenty-first resolution of the combined General Meeting of shareholders of 31 August 2020, and taking into account the volume-weighted average of AB Science's share price over the twenty trading sessions preceding the date of the Board of Directors' meeting of 1 September 2020, which stood at 8.79 euros, the subscription price of all 6.0 million D3 shares was set at 241,231 euros.

In accordance with their terms and conditions which are listed in the articles of association of AB Science, the class D3 preferred stock will not confer any voting rights or any financial rights on holders until AB Science has obtained two marketing authorisations (from the European Medicines Agency or the US Food and Drug Administration) for one or more of its drug candidates in two different indications, these two marketing authorisations to be obtained no later than 31 December 2030. In addition, in the event of a public and/or exchange offer for AB Science, the Board of Directors will have the option of deciding on the conversion of all D3 category preferred stock in circulation into common shares based on a 1:1 conversion ratio.

No other event that is likely to have an impact on the financial position of the Company has occurred since closing.

III. Consolidated financial statements for the first half of 2020

The Companys turnover, entirely generated by the commercialization of a drug in veterinary medicine, amounts to 807 K for the first half of 2019, as compared with 791 K 1 year earlier, which represents an increase of 2%.

Operating expenses

(In thousands of euros) 30.06.2020 30.06.2019Cost of sales 74 121Marketing expenses 449 551Administrative costs 1,059 1,098Research and development costs 6,121 9,600Other operating expenses 0 0Total operating expenses 7,702 11,370

The Companys operating expenses amounted to 7,702 K on 30 June 2020 as compared with 11,370 K on 30 June 2019, corresponding to a decrease of 32.3%

The Companys marketing decreased by 18.5%, from 551 K on 30 June 2019 to 449 K on June 30 2020.

Administrative expenses decreased by 3.6% from 1,098 K on 30 June 2019 to 1,059 K on 30 June 2020.

Research and development expenses decreased by 36.2%, from 9,600 K as of 30 June 2019 to 6,121 K as of30 June 2020. This decrease is explained by the termination of many masitinib studies, which triggered a decrease of the clinical costs (clinical partners, hospitals, laboratory,).

Operating profit/loss

The operating loss as at 30 June 2020 amounted to 6,895 K as compared with 10,579 K as of 30 June 2019,which is a decrease of the operating loss by 3,684 K (34.8%).

Financial profit/loss

The financial loss as of 30 June 2020 was 1,897 K, as compared with a loss of 2,434 K a year earlier.

As of 30 June 2020, the 2,434 K loss was mainly related to the accounting at the fair value of the financial liabilities. This variation generated a non-recurring and non-cash effect income.

The 1,897 K loss of 30 June 2020 is also and mainly related to the recognition of the change in fair value of financial liabilities (-1,859 K). This change generated a non-recurring loss with no effect on cash. The valuation of this financial liability is explained in Note 12.3 of the appendix to the consolidated financial statements of this report.

Net profit/loss

The total net loss as at 30 June 2020 amounted to 8,801 K, as compared to 13,016 K as of 30 June 2019, a decrease of 32.4% for the reasons mentioned above.

IV. Consolidated balance sheet information

Assets

Given the stage of product development, development costs were expensed, marketing prospects being difficult to evaluate. Fixed assets correspond essentially to the cost of registration of the Companys patents. Registration costs of the Companys patents booked as net fixed assets slightly decreased as compared to 30 June 2019 and amounts to 1,479 K as at 30 June 2020.

According to IFRS 16 guidelines, leases with a duration of more than 12 months are now recognized as assets by the recognition of a right of use. This amounts to 1,812 K as of June 30, 2020.

Inventory amounted to 151 K as of 30 June 2020 as compared with 176 K as of 31 December 2019.

Trade receivable increased by 157K and amount to 354 K as of June 30, 2020, as compared with 197 K as of June 30, 2019.

As of 30 June 2020, there is no current financial asset. These financial assets correspond to cash instruments, theterm of which is beyond 3 months. As of 30 June 2020, there is no cash with a term beyond 3 months.

Other current assets are stable. They amount to 8,058 K as of 30 June 2020, as compared with 7,962 K as of 31 December 2019.

Total cash and current financial assets amount to 10,559 K as of June 30, 2020, as compared with 5,695 K as of 31 December 2019.

Liabilities

Funding used by the Company comes mainly from issue of bond loan agreements, issue of new shares and various public aids (research tax credits, reimbursable advances and grants).

The table hereafter shows the change in the Companys equity between 31 December 2019 and 30 June 2020.

(in thousands of euros) ? IFRS norms Company EquityEquity as of 31 December 2019 (26 829)Capital increases and additional paid-in capital net of issuance 7 329costsTotal profit/loss over the period (8 713)Conversion options 0Payments in shares 48Equity as of 30 June 2020 (28 166)

As of 30 June 2020, shareholders' equity amounted to 28,166 K.

Current liabilities amount to 24,082 K as of 30 June 2020 against 19,527 K in late 2019, which represents an increase of 23.3%.This increase of 4,555 K can be explained by the following effects:

-- The increase of the accounts payable: 653 K -- The increase of current liabilities: 4,642 K. This increase results from the completion of a loan issued as part of the pre-financing of the 2019 research tax credit of $5.1 million in June 2020, repayable no later than 31 December 2020. -- The increase of other current liabilities: 559 K

Non-current liabilities amount to 26,736 K as of 30 June 2020 against 25,043 K as of 31 December 2019, an increase of 1,693 K, which is explained by the following reasons:

-- The increase of cash instruments (1,856 K). This variation is mainly due to the cash instruments fair value variation -- The decrease of lease obligations (IFRS 16): 145 K

V. Risk factors and uncertainties

Additionally to the risks and uncertainties described in Chapter 5 of the Annual Financial Report to 31 December 2019, the Company is exposed to the following risks and uncertainties related to clinical study results.

Results of ongoing clinical studies with masitinib will be reported in the coming weeks and months The exact timing of reporting these results may be affected by the need to file patent applications depending on the nature of the results obtained. Nevertheless, the next clinical milestones are :

-- Results of the final phase 3 analysis in severe asthma uncontrolled by inhaled corticosteroids and with elevated eosinophil level; -- Results of the final phase 3 analysis in Alzheimers disease; -- Results of the final phase 3 analysis in pancreatic cancer; -- Results of the final phase 3 analysis in prostate cancer. -- Foreseeable evolution of the Group's situation and future prospects

In 2020, AB Science continues to allocate most of its resources to the development of masitinib, the most advanced molecule of the Company.

The Company is launching two confirmatory studies:

-- in amyotrophic lateral sclerosis; -- in systemic indolent mastocytosis.

Finally, AB Science intends to launch a phase 1/2 study in refractory acute myeloid leukemia with a new molecule developed by AB Science (AB8939).

About AB ScienceFounded 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 Companys 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 Sciences website: www.ab-science.com.

Forward-looking Statements - AB ScienceThis 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 Autorit des Marchs 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 obligationor 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.

For additional information, please contact:

AB ScienceFinancial Communication & Media Relations investors@ab-science.com

FINANCIAL STATEMENTS AS OF 30 JUNE 2020

Assets (in thousands of euros) 30/06/2020 31/12/2019Intangible assets 1 479 1 417Tangible assets 175 193Use rights related to leases 1 812 1 979Non-current financial assets 65 67Other non-current assets 0 0Deferred tax assets 0 0Non-current assets 3 531 3 656Inventory 151 230Trade receivable 354 197Current financial assets 0 0Other current assets 8 058 7 962Cash and cash equivalent 10 559 5 695Current assets 19 122 14 085TOTAL ASSETS 22 653 17 740 Liabilities (in thousands of euros) 30/06/2020 31/12/2019Share capital 446 435Additional paid-in capital 210 209 202 891Translation reserve (65) (72)Other reserves and results (238 756) (230 083)Total equity attributable to equity holders of the (28 166) (26 829)CompanyNon-controlling interests Total equity (28 166) (26 829)Non-current provisions 801 817Non-current financial liabilities 24 402 22 546Other non-current liabilities 0 0Non-current lease obligations 1 534 1 679Deferred tax liabilities 0 0Non-current liabilities 26 736 25 043Current provisions 224 237Trade payable 14 350 15 003Current financial liabilities 4 649 7Tax liabilities / Tax payable 0 0Current lease obligations 355 333Other current liabilities 4 505 3 946Current liabilities 24 082 19 527TOTAL EQUITY AND LIABILITIES 22 653 17 740

STATEMENT OF COMPREHENSIVE INCOME 30 JUNE 2020

(in thousands of euros) 30/06/2020 30/06/2019Revenue 807 791Other operating revenues 0 0Total revenues 807 791Cost of sales (74) (121)Marketing expenses (449) (551)Administrative expenses (1 059) (1 098)Research and development expenses (6 121) (9 600)Other operating expenses - -Operating income (6 895) (10 579)Financial income 186 42Financial expenses (2 083) (2 476)Financial income (1 897) (2 434)Income tax expense (8) (4)Net income (8 801) (13 016)Other comprehensive income Items that will not be reclassified subsequently to net income:- Actuarial differences 80 (4)Items that should be reclassified subsequently to net income:- Translation differences ? Foreign 8 (5)operationsOther comprehensive income for the period 88 (9)net of taxTotal comprehensive income for the period (8 713) (13 025)Net income for the period attributable to: - Attributable to non-controlling interests - -- Attributable to equity holders of the (8 801) (13 016)parent CompanyComprehensive income for the period attributable to:- Attributable to non-controlling interests - -- Attributable to equity holders of the (8 713) (13 025)parent CompanyBasic earnings per share - in euros (0,23) (0,34)Diluted earnings per share - in euros (0,23) (0,34)

CONSOLIDATED STATEMENT OF CASH FLOWS

(in thousands of euros) 30/06/ 30/06/ 2020 2019Net income (8 801) (13 016)- Adjustment for amortization and charges to provisions 524 568- Adjustment for income from asset sales 0 0- Non-cash income and expenses linked to share-based payments 48 56- Other non-cash income and expenses 1 660 2 236- Adjustment for income tax expense 0 0- Adjustment for change in deferred tax 0 0- Impact of change in working capital requirement generated by (1 203) (694)operating activities- Income from interest on financial assets 72 38- Cash flow from operations before tax and interest (7 700) (10 812)- Income Tax (paid) / received 0 0Net cash flow from operating activities (7 700) (10 812)Acquisitions of fixed assets (205) (177)Sales of tangible and intangible assets 0 0Acquisitions of financial assets 0 0Proceeds from the sale and financial assets 0 0Changes in loans and advances 33 0Interest received / (paid) (62) (39)Other cash flow related to investing activities 0 0Net cash flow from investing activities (234) (217)Dividends paid Capital increase (decrease) 7 329 0Issue of loans and receipt of conditional advances 5 464 2 197Repayments of loans and conditional advances (3) (3)Other cash flows from financing activities 0 0Net cash flow from financing activities 12 790 2 194Effect of exchange rate fluctuations 8 (5)Effect of assets held for sale 0 0Impact of changes in accounting principles 0 0Net increase /decrease in cash and cash equivalents ? by cash 4 863 (8 839)flows Cash and cash equivalents ? opening balance 5 695 11 560Cash and cash equivalents ? closing balance 10 559 2 721Net increase / decrease in cash and cash equivalents ? by 4 863 (8 839)change in closing balances



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-- AB SCIENCE press release S1 2020 VEng VF