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 credit
to 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
§ 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 world’s largest congress specializing in the field of allergy and clinical immunology.
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.
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.
§ 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 n°2014-283 of 4 March 2014 for the implementation of Article 70 of 2014 Finance Law n°2013-1278 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 world’s 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 masitinib’s 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-called “Conversion” 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 Company’s 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%.
(In thousands of euros)
Cost of sales
Research and development costs
Other operating expenses
Total operating expenses
The Company’s 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 Company’s 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 of
30 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,…).
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%).
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.
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
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 Company’s patents. Registration costs of the Company’s 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, the
term 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.
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 Company’s equity between 31 December 2019 and 30 June 2020.
(in thousands of euros) – IFRS norms
Equity as of 31 December 2019
Capital increases and additional paid-in capital net of issuance costs
Total profit/loss over the period
Payments in shares
Equity as of 30 June 2020
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 Alzheimer’s 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 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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FINANCIAL STATEMENTS AS OF 30 JUNE 2020
Assets (in thousands of euros)
Use rights related to leases
Non-current financial assets
Other non-current assets
Deferred tax assets
Current financial assets
Other current assets
Cash and cash equivalent
Liabilities (in thousands of euros)
Additional paid-in capital
Other reserves and results
Total equity attributable to equity holders of the Company
Non-current financial liabilities
Other non-current liabilities
Non-current lease obligations
Deferred tax liabilities
Current financial liabilities
Tax liabilities / Tax payable
Current lease obligations
Other current liabilities
TOTAL EQUITY AND LIABILITIES
STATEMENT OF COMPREHENSIVE INCOME 30 JUNE 2020
(in thousands of euros)
Other operating revenues
Cost of sales
Research and development expenses
Other operating expenses
Income tax expense
Other comprehensive income
Items that will not be reclassified subsequently to net income:
- Actuarial differences
Items that should be reclassified subsequently to net income:
- Translation differences – Foreign operations
Other comprehensive income for the period net of tax
Total comprehensive income for the period
Net income for the period attributable to:
- Attributable to non-controlling interests
- Attributable to equity holders of the parent Company
Comprehensive income for the period attributable to:
- Attributable to non-controlling interests
- Attributable to equity holders of the parent Company
Basic earnings per share - in euros
Diluted earnings per share - in euros
CONSOLIDATED STATEMENT OF CASH FLOWS
(in thousands of euros)
- Adjustment for amortization and charges to provisions
- Adjustment for income from asset sales
- Non-cash income and expenses linked to share-based payments
- Other non-cash income and expenses
- Adjustment for income tax expense
- Adjustment for change in deferred tax
- Impact of change in working capital requirement generated by operating activities
- Income from interest on financial assets
- Cash flow from operations before tax and interest
- Income Tax (paid) / received
Net cash flow from operating activities
Acquisitions of fixed assets
Sales of tangible and intangible assets
Acquisitions of financial assets
Proceeds from the sale and financial assets
Changes in loans and advances
Interest received / (paid)
Other cash flow related to investing activities
Net cash flow from investing activities
Capital increase (decrease)
Issue of loans and receipt of conditional advances
Repayments of loans and conditional advances
Other cash flows from financing activities
Net cash flow from financing activities
Effect of exchange rate fluctuations
Effect of assets held for sale
Impact of changes in accounting principles
Net increase /decrease in cash and cash equivalents – by cash flows
Cash and cash equivalents – opening balance
Cash and cash equivalents – closing balance
Net increase / decrease in cash and cash equivalents – by change in closing balances