Acticor Biotech Announces Its 2021 Full-year Financial Results and Gives an Update on Its Clinical Development

PARIS--(BUSINESS WIRE)-- Regulatory News:

Acticor Biotech (Paris:ALACT), a clinical stage biotechnology company developing an innovative drug for the treatment of cardiovascular emergencies, today announced its full-year results for the period ended 31 December 2021, as approved by the Board of Directors on 29 March 2022, and gave an update on its clinical development. The full-year financial report will be included in a registration document due to be published on 27 April 2022.

Gilles Avenard, Chief Executive Officer and founder of Acticor Biotech, comments: “To carry out our clinical trials in treating cardiovascular emergencies, which remains a key public health concern, we have strengthened our financial capacity thanks in particular to our successful IPO on the Euronext Growth market in Paris in October 2021. As a result of this fundraising round supported by our existing shareholders as well as a number of new shareholders, we will continue with the clinical development of our first-in-class drug glenzocimab in stroke treatment. We recently obtained very promising results for our ACTIMIS phase 1b/2a clinical trial in this indication, and which confirm the clinical interest of GPVI inhibition. In keeping with the roadmap set out at the time of our IPO, we have made a calm and enthusiastic start to 2022, with major clinical milestones to come such as recruiting the first patients in the United States for the ACTISAVE phase 2/3 clinical trial, as well as the start of the GREEN phase 2/3 trial, both in stroke treatment.”

Main financial information (audited – in accordance with IFRS)

Given the Company’s stage of clinical development, it does not generate any revenue.

Research and development costs¹ amounted to €7,766 thousand in 2021 compared with €5,770 thousand in 2020. This increase is mainly due to the conduct of the ACTIMIS and GARDEN clinical trials, recruitment for which ended in 2021, as well as the start of the ACTISAVE phase 2/3 clinical trial in Europe and the rise in staff costs.

Operating and administrative expenses amounted to €3,749 thousand in 2021 compared with €1,483 thousand in 2020. This increase relates primarily to fees and charges incurred within the framework of the IPO on Euronext Growth Paris.

The Company therefore sustained a net loss of €12,608 thousand in 2021 compared with €7,651 thousand in 2020.

Cash and cash equivalents totalled €11.3 million at 31 December 2021, thanks in particular to the capital increase within the framework of Acticor Biotech’s IPO, which raised €15.5 million.

Highlights since the IPO

• October 2021 - Successful IPO on Euronext Growth® in Paris

The IPO enabled the Company to carry out a €15.5 million capital increase by issuing 2,178,176 new ordinary shares.

• November 2021 - FDA approval of the IND application for glenzocimab in acute ischemic stroke

The US Food and Drug Administration (FDA) has approved the launch in the United States of the clinical development of glenzocimab, a new humanised monoclonal antibody fragment to be used on acute ischemic stroke patients. This active Investigational New Drug (IND) application represents a major step forward and marks the start in the United States of America of the ACTISAVE phase 2/3 clinical trial, evaluating the efficacy of glenzocimab in treating ischemic stroke, in combination with the reference treatment in this indication.

• February 2022 - Results of the GARDEN phase 2 clinical trial in Covid-19-related respiratory distress syndrome

The results of the GARDEN clinical trial evaluating the use of glenzocimab on Covid-19 patients presenting with acute respiratory distress syndrome (ARDS) confirmed glenzocimab’s high level of tolerance administered in a 1000 mg dose for three consecutive days. It was not possible to demonstrate any difference in the main criterion of efficacy, i.e., progression to clinical aggravation, between glenzocimab and the placebo, both combined with standard treatments. An imbalance in inclusion was observed with regard to the risk factors recognised within this population not in favour of glenzocimab involving patients who usually have high blood pressure, are diabetic or older.

• February 2022 - Positive results of the ACTIMIS phase 1b/2a clinical trial on patients presenting with Acute Ischemic Stroke (AIS)

The positive results of the ACTIMIS phase 1b/2a clinical trial evaluating glenzocimab in combination with the reference treatment (thrombolysis with or without thrombectomy) in patients presenting with acute ischemic stroke (AIS) demonstrated glenzocimab’s very favourable safety profile by meeting the main criterion of the trial as well as a significant reduction in the number of intracerebral haemorrhages and mortality in the group treated with glenzocimab.

• March 2022 - Appointment of Corinne Le Goff to the Board of Directors as independent board member

Corinne Le Goff has agreed to join Acticor Biotech’s Board of Directors as an independent board member. Her appointment will be submitted to the shareholder vote at the combined general meeting of 12 May 2022.

Outlook for 2022

Acticor Biotech’s clinical strategy consists of developing its drug, glenzocimab, across several major indications in the treatment of cardiovascular emergencies. Two phase 2/3 trials are planned in stroke treatment, including ACTISAVE, which began in Europe in 2021. The company is also extending its clinical development programme to other indications such as pulmonary embolism and myocardial infarction, for which phase 2 trials are planned to be launched this year.

• Recruitment of the first US patient in the ACTISAVE phase 2/3 trial with glenzocimab in ischemic stroke, in combination with the reference treatment in this indication - 2^nd quarter of 2022

• Presentation of final results of the ACTIMIS phase 1b/2a clinical trial on patients presenting with acute ischemic stroke (AIS) – 2^nd quarter of 2022

• Recruitment of the first patient in the GREEN phase 2/3 trial in stroke, funded by Assistance Publique-Hôpitaux de Paris (AP-HP) – 2^nd half of 2022

• Launch of two phase 2 clinical trials in pulmonary embolism (BREATH trial) and myocardial infarction (LIBERATE trial) – end of 2^nd half of 2022

Next financial publication: Results for the 1^st half of 2022, on September 29, 2022 (after market closing)

About ACTICOR BIOTECH

Acticor Biotech is a clinical stage biopharmaceutical company, a spin-off from INSERM (the French National Institute of Health and Medical Research), which is aiming to develop an innovative treatment for cardiovascular emergencies, including ischemic stroke.

Acticor Biotech is developing glenzocimab (ACT017), a humanized monoclonal antibody (mAb) fragment directed against a novel target of major interest, platelet glycoprotein VI (GPVI). Glenzocimab inhibits platelet binding to the thrombus without affecting physiological hemostasis, thereby limiting the bleeding risk, particularly in the brain.

Acticor Biotech is supported by a panel of European and international investors (Karista, Go Capital, Newton Biocapital, CMS Medical Venture Investment (HK) Limited, A&B (HK) Limited, Mirae Asset Capital, Anaxago, Primer Capital, Mediolanum farmaceutici and the Armesa foundation). Acticor Biotech has been listed on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 – ALACT).

For further information, please go to www.acticor-biotech.com

¹ Net of research tax credit and subsidies

Disclaimer

This press release contains certain forward-looking statements concerning Acticor Biotech and its business. Such forward-looking statements are based on assumptions that Acticor Biotech considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the Document de référence registration document filed with the Autorité des marchés financiers (AMF- French Financial Market Authority) on September 27,2021 under n°I.21-054 and to the development of economic conditions, financial markets and the markets in which Acticor Biotech operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Acticor Biotech or not currently considered material by Acticor Biotech. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Acticor Biotech to be materially different from such forward-looking statements.

Appendix 1 – Individual financial statements at December 31, 2021 restated according to IFRS and consolidated financial statements at December 31, 2020 prepared according to IFRS

The Statutory Auditors have performed their audits of the Individual financial statements at December 31, 2021 restated according to IFRS and consolidated financial statements at December 31, 2020 prepared according to IFRS and will continue to review subsequent events until the date their report is issued.

The financial statements for the period ended 31 December 2021 were approved by the Board of Directors on 29 March 2022 and will be submitted to shareholders at the annual general meeting scheduled for 12 May 2022.

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