On September 30, 2021 AB Science SA (Euronext – FR0010557264 – AB) reported its revenues for the first half of 2021 and provides an update on its activities (Press release, AB Science, SEP 30, 2021, View Source [SID1234591054]).
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FINANCIAL SITUATION KEY ELEMENTS AS OF 30 JUNE 2021
Decrease of the operating loss
The operating loss as of 30 June 2021 was 6,040 K€, compared with 6,895 K€ as of 30 June 2020, a decrease in the operating loss of 855 K€ (12.4%). This decrease is mainly due to the decrease in research and development costs during the period.
Strengthening of the cash position and financial visibility
Total cash and current financial assets amounted to 17,646 K€ as of 30 June 2021. This amount does not take into account the €3.3 million of 2020 tax credit to be reimbursed by the Public Finance Department.
In addition, the amount of off-balance sheet commitments received as of 30 June 2021 was €90 million. These commitments include:
A loan agreement for a total amount of €15 million signed with the EIB in November 2020
A firm financing option from historical shareholders for an amount of €25 million in the next 12 months, at the initiative of AB Science
A commitment of an additional 50 million euros, at the rate of 25 million per year from the first anniversary date, 1 July 2022, subject to an absence of event clause significantly unfavorable
Off-balance sheet commitments are detailed in paragraph 22 of the appendix to the half-year consolidated accounts.
CLINICAL DEVELOPMENT KEY EVENTS DURING THE FIRST HALF OF 2021 AND SINCE JUNE 30, 2021
Progressive resumption of patient enrollment in ongoing masitinib studies
AB Science announced the progressive resumption of patient enrollment in the confirmatory Phase 3 study (AB19001) in amyotrophic lateral sclerosis, the confirmatory Phase 3 study (AB15003) in mastocytosis and the Phase 2 study (AB20001) in Covid-19.
This resumption follows the decision in June 2021 to voluntarily suspend the inclusion of new patients in clinical studies with masitinib after the detection of a potential risk of ischemic heart disease with masitinib, and the validation by the ANSM of a risk management plan proposed by AB Science to reinforce patient safety.
Launch of an antiviral treatment for Covid-19
Publication in the journal Science
AB Science announced publication of a peer-reviewed article titled ‘Masitinib is a broad coronavirus 3CL inhibitor that effectively blocks replication of SARS-CoV-2’ in the journal Science. The article reports on research that identifies masitinib as a broad antiviral agent capable of treating SARS-CoV-2 (the virus that causes COVID-19), including demonstration of in vivo activity in mice, with efficacy maintained, in vitro, against SARS-CoV-2 variants of concern.
Launch of a second Phase 2 study in Covid-19
AB Science announced it has received approval to commence a second Phase 2 study in Covid-19. This study will evaluate the antiviral efficacy of masitinib at 3 different dosages, administered as an add-on to best supportive care, with respect to placebo plus best supportive care. The primary efficacy objective will be to demonstrate that masitinib can reduce the viral load of SARS-CoV-2 (the virus responsible for COVID-19) faster than a placebo control group, which will receive best supportive care. The population of study AB21002 therefore targets ambulatory (non-hospitalized) patients with mild disease or hospitalized patients without requirement for non-invasive ventilation (a score of 4 and 5 on the WHO clinical progression scale for COVID-19).
Collaboration with the University of Chicago in order to develop masitinib back-ups as antiviral drugs
AB Science together with the University of Chicago, announced the signing of an exclusive licensing agreement for conducting research on the prevention and treatment of humans infected with nidoviruses, coronaviruses and picornaviruses.
Under this agreement, AB Science will supply masitinib and more than 130 other AB Science proprietary drugs that have demonstrated activity against SARS-CoV-2 main protease 3CL-Pro via virtual screening methodology, and will benefit from the proprietary research platform of the University of Chicago.
Publication of long-term data showing that masitinib extended survival in amyotrophic lateral sclerosis by 25 months, provided that treatment starts early in disease course
The survival analysis followed all patients originally randomized in study AB10015 for an average duration of 75 months from the date of diagnosis. In ALS patients with mild or moderate disease severity at baseline, it was seen that treatment with 4.5 mg/kg/day masitinib as an add-on to standard riluzole prolonged survival by 25 months relative to those treated with riluzole alone, with a 44% reduced risk of death. Patients with mild or moderate disease severity correspond closely to the patient cohort enrolled in confirmatory phase 3 study, AB19001.
This new survival data has been published in in the peer-reviewed journal Therapeutic Advances in Neurological Disorders.
Launch of a Phase I/II study with AB8939 in acute myeloid leukemia
AB Science announced that its clinical trial with AB8939 in adult patients with relapsed/refractory acute myeloid leukemia (AML) has been approved by Health Canada.
AB8939 is a new generation synthetic microtubule destabilizer with the ability to overcome multidrug resistance and the potential for broad applicability as a potent anticancer drug.
The therapeutic potential of AB8939 has been demonstrated by preclinical results. In vivo data in a mouse model showed that AB8939, administered alone or in combination with Ara-C, increased survival compared to Ara-C alone.
AB8939 was entirely discovered by the laboratories of AB Science, which retains full ownership of intellectual rights, and is an example of AB Science’s focus on innovative drug development focused on improving patients’ lives.
Clinical results in Prostate Cancer
Masitinib Phase 2B/3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy met its predefined primary endpoint. The study results were presented at the American Urological Association (AUA) 2021 Annual Meeting, held on September 10-13, 2021.
CONSOLIDATED FINANCIAL INFORMATION FOR THE FIRST HALF OF 2021
The operating loss at of June 30, 2021 was 6,040 K€, compared to a loss of 6,895 K€ as of June 30, 2020, i.e. a decrease in the operating loss of 855 K€ (12.4%).
Operating revenues, exclusively consisting of revenue from the operation of a veterinary medicine drug, amounted to 818 K€ as of June 30, 2021, compared to 807 K€ one year earlier.
Operating expenses amounted to 6,858 K€ as of June 30, 2021, compared to 7,702 K€ as of June 30, 2020, a decrease of 10.9%.
Marketing expenses decreased by 47.4% from 449 K€ as of June 30, 2020 to 236 K€ as of June 30, 2021.
Administrative expenses increased by 25.2%, from 1,059 K€ as of June 30, 2020 to 1,326 K€ as of June 30, 2021.
Research and development expenses decreased by 13.4%, from 6,121 K€ as of June 30, 2020 to 5,299 K€ as of June 30, 2021. This variation is explained by the end of a number of studies where masitinib is being developed, which has led to a decrease in clinical costs (clinical partners, hospitals, laboratories, etc.).
The financial income as of June 30, 2021 is a gain of 1,386 K€ compared to a loss of 1,897 K€ one year earlier.
As of June 30, 2020, the loss of 1,897 K€ is mainly related to the recognition in the IFRS consolidated accounts of the change in fair value of financial liabilities. This change resulted in a non-recurring, non-cash loss.
The gain of 1,386 K€ as of June 30, 2021 is also and mainly related to the recognition in the IFRS consolidated accounts of the change in fair value of financial liabilities. This variation generates a non-recurring gain with no effect on cash. As these liabilities are mainly composed of instruments convertible into ordinary shares, their fair value varies according to the price of the AB Science share, i.e. a decrease over the half-year.
The net loss as of June 30, 2021 amounts to 4 655 K€ compared to a loss of 8 801 K€ as of June 30, 2020.
The following table summarizes the consolidated financial statements for the first half of 2021 prepared in accordance with IFRS, and comparative information with the first half of 2020:
OTHER CORPORATE INFORMATION FOR THE FIRST HALF OF 2021
State-guaranteed loan (PGE)
AB Science has obtained in March and April 2021 the agreement of Société Générale, Bpifrance and Banque Populaire for a total of 6 million euros in financing in the form of a state-guaranteed loan (PGE – prêt garanti par l’État), in the context of the COVID-19 pandemic.
Each bank provided a loan of 2 million euros. This loan is 90% guaranteed by the French State, with an initial maturity of 12 months and an extension option of up to five years, exercisable by AB Science.
Agreement with historical shareholders to implement a joint strategy to increase the value of masitinib
AB Science announced that it has signed an agreement with historical shareholders to implement a joint strategy to increase the value of masitinib. Under this agreement, these historical shareholders, representing today 8.7% of the company’s share capital, undertake to act in concert with the founding shareholders of AB Science in order to:
study strategies to optimize the value of masitinib, in particular in the context of a potential strategic alliance with one or several pharmaceutical company(ies) for the clinical development and commercialization of masitinib in one or more major indication(s), and/or in one or more major region(s); and
to study the opportunity of listing AB Science on a foreign market, in particular the NASDAQ (through an American Depository Receipts program).
The agreement will be implemented subject to the condition of obtaining a final exemption decision from the French Autorité des Marchés Financiers, free and clear of any appeal, confirming that there is no need for a public offer.
This agreement also includes the signature of a firm financing option for an amount of €25 million over the next 12 months, at the initiative of AB Science. These financings will have to be carried out within the framework of the "private placement" or "capital increase reserved for categories of persons" resolutions that are currently in place. With this agreement, AB Science’s financial visibility is extended beyond 24 months. This funding commitment may be increased by an additional 50 million euros, at the rate of 25 million euros per year from the first anniversary date, subject to a clause of absence of significantly unfavorable event.
Finally, this agreement includes a lock-up by certain minority shareholders on 1.8 million shares for a period of three years (or until the implementation of the value enhancement strategy if this occurs before the end of the three-year period).
Changes in the Board of Directors
AB Science has announced the reorganization of its Board of Directors with the co-optation of four new independent directors, Cécile de Guillebon, replacing Nathalie Riez, Catherine Johnston-Roussillon, replacing Emmanuel Mourey, Guillemette Latscha, replacing Béatrice Bihr, and Renaud Sassi, replacing Jean-Pierre Kinet.
Shareholders’ agreements expiring in 2021
Some agreements expire in 2021. All these agreements are described in chapter 8.5 of the annual financial report as of December 31, 2020.
Other securities transactions
During the first half of 2021, 21,845 share subscription warrants were granted.
AB Science confirms its eligibility for PEA-PME (a share savings plan aimed at providing finance to SMEs) in accordance with decree no. 2014-283 of 4 March 2014 taken for the application of article 70 of law no. 2013-1278 of 29 December 2013 of finance for 2014 fixing the eligibility of companies for PEA-PME, i.e. less than 5,000 employees on the one hand, an annual turnover of less than 1,500 million euros or a total balance sheet of less than 2,000 million euros, on the other hand.