- Successful IPO on Euronext Growth® in Paris
- Cash position of €11.3 million at 31 December 2021
- Promising clinical results with the continuing development
of glenzocimab for use in stroke
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 - 2nd quarter of
2022
- Presentation of final results of the ACTIMIS phase 1b/2a
clinical trial on patients presenting with acute ischemic
stroke (AIS) – 2nd 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) – 2nd half of 2022
- Launch of two phase 2 clinical trials in pulmonary
embolism (BREATH trial) and myocardial infarction
(LIBERATE trial) – end of 2nd half of 2022
Next financial publication:
Results for the 1st 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.
Income statement in accordance
with IFRS
31/12/2021
12 months
€’000
31/12/2020
12 months
€’000
Net Research and development costs*
(7,766)
(5,770)
Including Research and development
costs
(10 770)
(7 244)
Including Grants
3,004
1,474
Operating and administrative expenses
(3,749)
(1,483)
Costs relating to share-based payments
(375)
(323)
Operating income (loss)
(11,889)
(7,576)
Financial expenses
(721)
(81)
Financial income
2
6
Profit (loss) before tax
(12,608)
(7,651)
Income tax
-
-
Net profit (loss) for the year
(12,608)
(7,651)
Attributable to shareholders of the parent
company
(12,608)
(7,651)
Non-controlling interests
-
-
31/12/2021
31/12/2020
Weighted average number of shares in
circulation (pro forma) (1)
7,780,292
6,358,500
Basic earnings per share (€ per share)
(pro forma) (1)
(1.62)
(1.20)
Diluted earnings per share (€ per share)
(pro forma) (1)
(1.62)
(1.20)
Statement of financial position
in accordance with IFRS
31/12/2021
€’000
31/12/2020
€’000
ASSETS
Intangible assets
713
713
Property, plant and equipment
98
181
Non-current financial assets
197
5
Total non-current assets
1,008
899
Trade receivables and related accounts
-
-
Other receivables
4,281
1,931
Current financial assets
-
-
Prepaid expenses
1,244
603
Cash and cash equivalents
11,348
7,587
Total current assets
16,873
10,121
Total assets
17,881
11,019
LIABILITIES AND EQUITY
Shareholders’ equity
Share capital
527
318
Additional paid-in capital
23,319
11,639
Other components of comprehensive
income
(32)
(37)
Accumulated losses attributable to
shareholders of the parent company
(188)
(2,553)
Net profit (loss) attributable to
shareholders of the parent company
(12,608)
(7,651)
Equity attributable to shareholders of
the parent company
11,018
1,717
Non-controlling interests
-
-
Total equity
11,018
1,717
Non-current liabilities
Obligations to employees
53
94
Non-current debt
2,200
2,400
Provisions
553
426
Total non-current liabilities
2,806
2,921
Current liabilities
Current debt
507
162
Trade payables
3,027
2,715
Tax and social security liabilities
522
255
Other current payables
-
3,250
Total current liabilities
4,057
6,382
Total liabilities and equity
17,881
11,019
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version on businesswire.com: https://www.businesswire.com/news/home/20220330005534/en/
ACTICOR BIOTECH Gilles AVENARD, MD CEO and Founder
gilles.avenard@acticor-biotech.com T. : +33 (0)6 76 23 38
13
Sophie BINAY, PhD General Manager and CSO
Sophie.binay@acticor-biotech.com T. : +33 (0)6 76 23 38
13
Yannick PLETAN, MD General Manager and CMO
Yannick.pletan@acticor-biotech.com T. : +33 (0)6 76 23 38
13
NewCap Mathilde BOHIN / Olivier BRICAUD Investor
Relations acticor@newcap.eu T. : +33 (0)1 44 71 94 95
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