- Significant clinical progress in the treatment of stroke
with glenzocimab:
- Positive results from the ACTIMIS phase 1b/2a study
- Patent granted to protect glenzocimab in thrombotic diseases
in Europe until 2036
- Obtained "PRIME" status from the European Medicines
Agency
- More than 150 patients enrolled to date in the ACTISAVE
Phase 2/3 study in Europe and the US
- Strong outlook for portfolio development by the end of
2022:
- Launch of the GREEN Phase 2/3 study in stroke
- Launch of the LIBERATE phase 2 study in myocardial
infarction
- Initiation of regulatory reviews in Europe and the
US
Regulatory News:
Acticor Biotech (Paris:ALACT), a clinical stage biotechnology
company developing an innovative drug for the treatment of
cardiovascular emergencies, today announced its half-year results
for the period ended 30 June 2022, as approved by the Board of
Directors on 27 October 2022, and provides an update on its
clinical progress.
The 2022 half-yearly financial report is made available to the
public and is accessible on the Investors/Regulated Information
section of the company's website:
https://www.acticor-biotech.com/investors/regulated-information-2/regulated-information.
Gilles Avenard, Chief Executive Officer and founder of
Acticor Biotech, comments: “During the first semester of this
year, Acticor Biotech demonstrated the full potential of its drug
candidate, glenzocimab, with very promising clinical results in the
ACTIMIS Phase 1b/2a trial in stroke. We have since accelerated our
clinical development plan around this first indication in our
ACTISAVE Phase 2/3 study, which is well underway with more than 150
patients enrolled to date across Europe and the United States. We
are also preparing for the launch of a second Phase 2/3 GREEN study
sponsored by Assistance Publique-Hôpitaux de Paris (AP-HP) by the
end of this year. Our interactions with regulatory authorities for
glenzocimab in stroke have strengthened, with the European
Medicines Agency granting PRIME status, and we have filed for Fast
Track status with the US FDA. We look forward to deploying our
clinical and regulatory strategy to address the important medical
challenge of stroke and cardiovascular emergencies more
broadly.”
Main financial information
(limited review – in accordance with IFRS)
Given the Company’s stage of clinical development, it does not
generate any revenue.
Research and development costs1 amounted to €4,918
thousand at 30 June 2022, compared with €4,379 thousand in the
first half of 2021. This slight increase is mainly due to the
progress of the ACTISAVE clinical trial in phase 2/3.
Operating and administrative expenses amounted to €1,917
thousand at 30 June 2022, compared to €1,258 thousand at 30 June
2021. These expenses include, in particular, personnel costs and
expenses related to the Company's listing.
The operating loss for the period was €7,270 thousand,
compared with €5,741 thousand at 30 June 2021.
As a result, the Company recorded a net loss of €7,310
thousand at 30 June 2022, compared to €5,906 thousand at the same
period in 2021.
At 30 June 2022, cash and cash equivalents amounted to
€4.9 million, compared with €11.3 million at 31 December 2021.
On October 17, 2022, the Company issued €3.9 million in bonds
convertible into shares from existing shareholders and €2.0 million
in simple bonds with warrants attached from a French investment
company.
Progress of Acticor Biotech's clinical
portfolio in the first half of 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.
These positive results were the subject of an oral presentation
at ESOC 2022 by Professor Mikael Mazighi, MD, PhD, Coordinating
Investigator for ACTIMIS.
The efficacy of glenzocimab is now being evaluated in an
international ACTISAVE phase 2/3 study, which will include 1,000
patients.
- Clinical development in other cardiovascular emergency
indications
The results of the GARDEN phase 2 clinical trial in
Covid-19-related respiratory distress syndrome confirmed the good
safety profile of glenzocimab, dosed at 1000 mg for three
consecutive days. However, it was not possible to show a difference
on the primary efficacy endpoint. In addition, Acticor Biotech has
decided to postpone the launch of its phase 2 BREATH study in
pulmonary embolism to focus its resources on the two phase 2/3
studies in stroke, ACTISAVE and GREEN.
- Patent granted in Europe for glenzocimab for the treatment
of cardiovascular emergencies
The European Patent Office has granted a patent providing
protection for glenzocimab in thrombotic diseases in Europe until
2036. This grant complements those already obtained in the United
States, Singapore and other jurisdictions that also protect
glenzocimab until 2036. Three patent families, comprising 4 issued
patents and 33 pending patent applications, protect glenzocimab and
its use.
Governance
- Appointment of Corinne Le Goff to the Board of Directors as
independent board member
Corinne Le Goff has joined 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.
Other significant clinical developments
after 30 June 2022
- European Medicines Agency grants “PRIME” status to
glenzocimab for the treatment of stroke
The "PRIME" status granted by the European Medicines Agency
(EMA) has recognised the unmet medical need and interest of
glenzocimab in the disease. This status allows Acticor Biotech to
strengthen its interactions and obtain early dialogues with
regulatory authorities to confirm the clinical development plan for
glenzocimab in stroke.
- Enrolment of the first US patient in its Phase 2/3 study
ACTISAVE for the treatment of stroke
In September 2022, the first US patient was enrolled at the CHI
Memorial Stroke and Neuroscience Center, Chattanooga, Tennessee, by
Dr. Ruchir A. Shah, MD. ACTICOR had obtained an IND2 for this study
from the US Food and Drug Administration (FDA) in November
2021.
As a reminder, the international phase 2/3 study, ACTISAVE,
plans to treat 1,000 patients in approximately 80 centres in the
United States, Europe (France, Germany, Belgium, Spain, Slovakia,
Denmark, Czech Republic), Great Britain and Israel. Enrolment in
Europe began in the third quarter of 2021. To date, the study has
enrolled more than 150 patients. A first futility analysis is
planned after the inclusion of the first 200 patients to confirm
the initial assumptions.
Outlook for 2022-2023
Acticor Biotech's clinical strategy is to develop its drug,
glenzocimab, in several major indications in the treatment of
cardiovascular emergencies: two phase 2/3 studies in stroke,
including ACTISAVE, which started in Europe in 2021, and a phase 2
study in myocardial infarction, which is expected to start this
year.
During the first semester of 2023, the Company will meet with
the European (EMA) and US (FDA) regulatory agencies to confirm the
overall development plan up to registration. Following the
amendments filed on the ACTISAVE study, a futility analysis will be
available in the second half of 2023 to confirm the assumptions
made following the ACTIMIS results.
The Company commissioned an independent international company
(IQVIA) to conduct a market and positioning study for glenzocimab
in the treatment of ischemic stroke. In this study, three
hypotheses were studied based on the clinical results obtained in
the ACTIMIS study and the expected results of the ACTISAVE and
GREEN studies. This qualitative and quantitative study gathered the
opinions of numerous experts, clinicians, and payers in 5 European
countries, in Japan and in the United States. The results confirm a
potential sales figure well more than US$1 billion and a very high
level of acceptability and interest in the product. A project value
study was also provided.
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.
In May 2022, Acticor Biotech presented positive results from its
Phase 1b/2a study, ACTIMIS, at the ESOC, confirming the safety
profile and showing a reduction in mortality and intracerebral
hemorrhage in the glenzocimab-treated group in patients with
stroke. The efficacy of glenzocimab is now being evaluated in an
international Phase 2/3 study, ACTISAVE, which will include 1,000
patients. In July 2022, Acticor Biotech was granted "PRIME" status
by the European Medicines Agency (EMA) for glenzocimab in the
treatment of stroke. This designation will allow the company to
strengthen its interactions and obtain early dialogues with
regulatory authorities.
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 is listed
on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 –
ALACT).
For more information, visit: www.acticor-biotech.com
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 as approved by the
Autorité des marchés financiers under number R. 22-011 on 26 April
2022 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.
APPENDICES
Income statement in
accordance with IFRS
30/06/2022
30/06/2021
6 months
6 months
€’000
€’000
Net Research and development costs
(4,918)
(4,379)
Including Research and development
costs
(6,237)
(5,663)
Including Grants
1,320
1,284
Operating and administrative expenses
(1,917)
(1,258)
Costs relating to share-based payments
(435)
(95)
Other operating income and expenses
-
(9)
Operating income (loss)
(7,270)
(5,741)
Financial expenses
(40)
(167)
Financial income
1
2
Profit (loss) before tax
(7,310)
(5,906)
Income tax
-
-
Net profit (loss) for the year
(7,310)
(5,906)
Attributable to shareholders of the parent
company
(7,310)
(5,906)
Non-controlling interests
-
-
Weighted average number of shares in
circulation (pro forma) (1)
10,545,776
7,853,512
Basic earnings per share (€ per share)
(pro forma) (1)
(0.69)
(0.75)
Diluted earnings per share (€ per share)
(pro forma) (1)
(0.69)
(0.75)
BALANCE SHEET
Statement of financial
position
in accordance with
IFRS
30/06/2022
31/12/2021
€’000
€’000
ASSETS
Intangible assets
713
713
Tangible assets
50
98
Non-current financial assets
325
197
Total non-current assets
1,088
1,008
Other receivables
4,562
4,281
Prepaid expenses
772
1,244
Cash and cash equivalents
4,894
11,348
Total current assets
10,228
16,873
Total assets
11,316
17,881
LIABILITIES AND EQUITY
Shareholders’ equity
Share capital
527
527
Additional paid-in capital
23,327
23,319
Other components of comprehensive
income
(3)
(32)
Accumulated losses attributable to
shareholders of the parent company
(12,232)
(188)
Net profit (loss) attributable to
shareholders of the parent company
(7,310)
(12,608)
Equity attributable to shareholders of
the parent company
4,309
11,018
Non-controlling interests
-
-
Total equity
4,309
11,018
Non-current liabilities
Obligations to employees
43
53
Non-current debt
1,948
2,200
Provisions
553
553
Total non-current liabilities
2,544
2,806
Current liabilities
Current debt
634
507
Trade payables
3,261
3,027
Tax and social security liabilities
568
522
Total current liabilities
4,463
4,057
Total liabilities and equity
11,316
17,881
Cash flow statement
under IFRS
30/06/2022
30/06/2021
€’000
€’000
Cash flow from operating
activities
Net profit for the period
(7,310)
(5,906)
(-) Elimination of depreciation of
tangible assets
(54)
(51)
(-) Unrealised foreign exchange
difference
1
-
(-) Provision for pension liabilities
(19)
(26)
(-) Provision for risks and charges
-
(4)
(-) Share-based payment expense
(435)
(95)
(-) Elimination of net finance costs
(39)
(115)
Cash flow before cost of net financial
debt and taxes
(6,763)
(5,614)
(-) Change in working capital
(472)
43
Taxes paid
Cash flow from operating
activities
(6,292)
(5,658)
Cash flow from investing
activities
Acquisition of tangible assets
(7)
(6)
Disposal price of the assets sold
-
1
Cash flow from investing
activities
(7)
(5)
Cash flow from financing
activities
Capital increase
-
5,055
Capital increase costs
-
(94)
Subscription of warrants
8
-
Gross financial interest paid
(10)
-
Repayment of advances
(123)
(50)
Convertible bond issue
-
1,962
Decrease in financial debt related to
lease obligations
(31)
-
Cash flow from financing
activities
(155)
6,873
Increase (decrease) in cash
(6,454)
1,210
Opening cash and cash equivalents
11,348
7,587
Cash and cash equivalents at end of
year
4,894
8,796
Increase (decrease) in cash
(6,454)
1,209
Cash and cash equivalents (including
current bank loans)
4,894
8,796
Cash and cash equivalents
4,894
8,796
Current bank loans
-
-
Cash and cash equivalents at the end of
the year (including current bank loans)
4,894
8,796
1 Net of research tax credit and subsidies 2 Investigational New
Drug Application
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221027005828/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
NewCap Mathilde BOHIN / Quentin MASSÉ Investor Relations
acticor@newcap.eu T. : +33 (0)1 44 71 94 95
NewCap Arthur ROUILLÉ Media Relations acticor@newcap.eu
T. : +33 (0)1 44 71 00 15
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