- Adaptation of the development plan for the ACTISAVE phase
2/3 study, with clinical results expected as early as Q2 2024, to
register glenzocimab in Europe and the United States by 2028 at the
latest
- UK regulatory agency (MHRA) approves protocol for LIBERATE
phase 2b study, first clinical trial to evaluate glenzocimab in
myocardial infarction
- Cash and cash equivalents of €8 million at June 30,
2023
Regulatory News:
Acticor Biotech, (ISIN: FR0014005OJ5 - ALACT), a clinical stage
biopharmaceutical company developing glenzocimab, an innovative
drug for the treatment of cardiovascular emergencies, today
publishes its half-year results to June 30, 2023, approved by the
Board of Directors on October 26, 2023, and provides an update on
its latest progress.
The 2023 half-year financial report is available to the public
on the Investors/Regulated Information section of the company's
website. The review of the half-year financial statements has been
completed. The limited review report is in the process of being
issued.
Financial highlights
(limited review - prepared in accordance with IFRS)
Given the Company's stage of clinical development, it does not
generate revenues.
Research and development costs1 amounted to €5,918
thousand euros at June 30, 2023, compared with €4,918 thousand
euros at June 30, 2022. This increase is mainly due to progress in
recruitment for the ACTISAVE phase 2/3 clinical trial.
Operating and administrative expenses amounted to 2,093
thousand euros at June 30, 2023, compared with 1,917 thousand euros
at June 30, 2022.
The operating loss amounted to 8,821 thousand euros over
the six-month period, compared with 7,270 thousand euros over the
same period in 2022.
As a result, the Company recorded a net loss of 10,081
thousand euros at June 30, 2023, compared with 7,310 thousand euros
for the same period in 2022.
At June 30, 2023, cash and cash equivalents amounted €8
million, compared with €6.6 million at December 31, 2022.
On March 9, 2023, the Company announced that it had
successfully raised €12.2 million to pursue its registration
ambition for glenzocimab in stroke.
At the date of preparation of these financial statements, the
Board of Directors considers that the Company will be able to cover
the financing requirements of its operating activities until at
least the beginning of the second quarter of 2024, based on the
following factors:
- Net cash and cash equivalents (including bank overdrafts) at
June 30, 2023, of 7,955 thousand euros;
- Receipt in October 2023 of the balance of the recoverable BPI
France advance of 1,200 thousand euros granted in November 2022 to
finance the development of glenzocimab;
- End of patient enrolment in the ACTISAVE study in October 2023,
leading to a sharp reduction in financing requirements from that
date onwards;
- Expected consumption of cash by the Company's activities over
the second half of 2023 and 2024.
- Ability of the Company to pre-finance its 2023 CIR;
- Ability of the Company to modulate its variable operating
expenses within the framework of its studies.
Beyond its liquidity horizon, the Company will need additional
funds to continue financing the development of its activities.
Management has already taken steps to seek additional
financing.
Major clinical and regulatory advances
in 2023
- Adaptation of the ACTISAVE phase 2/3 clinical trial in the
treatment of acute ischemic stroke
In September 2023, following consultations with the European
(EMA) and US (FDA) regulatory agencies, and in agreement with
ACTISAVE's scientific committee, Acticor Biotech decided to change
the primary endpoint of this study to a single, unique endpoint,
namely the reduction in the number of patients who died or suffered
severe disability as a result of the stroke (mRS score 4-6 at 90
days).
This modification of the primary endpoint, reducing the size of
the study to 400 patients from the 1,000 initially planned, will
thus enable clinical results to be obtained as early as the second
quarter of 2024.
To date, the ACTISAVE trial in the USA, Europe, Israel, and the
UK has enrolled over 430 patients.
Regarding the pharmaceutical development plan, Acticor received
the opinion of the EMA and FDA agencies in the summer of 2023. The
authorities confirmed the relevance of the registration strategy in
terms of validation of the production process and characterization
of glenzocimab. Recommendations have been proposed and will be
considered in the roadmap, with no impact on the registration
plan.
Based on the results of the ACTISAVE phase 2/3 study and the
recommendations of international stroke experts, Acticor plans to
consult the EMA and FDA again during 2024 to confirm that the phase
3 design will support registration in both Europe and the United
States, envisaged no later than 2028.
- Complementary results from AI-enhanced brain imaging data
confirm the mode of action of glenzocimab in stroke patients in the
ACTIMIS study
To better understand glenzocimab's mode of action in reducing
intracranial hemorrhage, a collaboration has been set up with
Brainomix, a UK-based company specializing in the evaluation of
AI-powered imaging biomarkers, to further analyze the brain imaging
results of the ACTIMIS study.
Using AI software developed by Brainomix, ischemic lesion and
hemorrhagic transformation volumes were measured and quantified.
This objective assessment of the evolution of the cerebral lesion
caused by the stroke was then compared with the clinical results.
Initial results obtained using these biomarkers showed that, after
treatment, patients receiving glenzocimab had lower volumes of
brain damage than patients receiving placebo (standard treatment
only), mainly due to a significant reduction in volumes of
hemorrhagic transformation. The benefit of glenzocimab appears more
pronounced in patients who underwent mechanical thrombectomy after
initial treatment with a thrombolytic agent.
- UK regulatory agency (MHRA) approves protocol for LIBERATE
study, the first clinical trial evaluating glenzocimab in
myocardial infarction
The LIBERATE study (IRAS -1005400), conducted in partnership
with the University of Birmingham (UK), and expert clinicians from
the Institute of Cardiovascular Sciences and University Hospitals
Birmingham NHS Foundation Trust, received all regulatory approvals
to launch the study in August 2023.
This randomized, double-blind Phase 2b study will include over
200 patients with ST-segment elevation myocardial infarction
(STEMI) scheduled for percutaneous coronary intervention. The aim
of the study is to assess the safety and efficacy of glenzocimab
1000 mg versus placebo in reducing myocardial infarction size after
90 days. The study will be conducted at two UK hospitals: Queen
Elizabeth Hospital, Birmingham and Northern General Hospital,
Sheffield. Patient enrolment is due to begin by the end of
2023.
- Start of patient enrolment in Phase 2/3 GREEN stroke
trial
Conducted under the auspices of Assistance Publique - Hôpitaux
de Paris, and part of the RHU BOOSTER program, with financial
support from the Agence Nationale de la Recherche and the Programme
Investissements d'Avenir, the GREEN study (NCT05559398) has begun
with the enrollment of the first patients at the beginning of
2023.
As a reminder, the primary objective of this study is to
evaluate the efficacy of glenzocimab in combination with
endovascular thrombectomy (EVT) versus EVT alone within the first
24 hours, on functional outcome at 90 days (mRS). Secondary
objectives are to evaluate the impact of glenzocimab on overall
survival, reperfusion, clinical improvement at 24 hours,
symptomatic and asymptomatic intracerebral hemorrhage, serious
adverse events (SAE), serious unexpected adverse events (SUSAR) and
quality of life. The study will include nearly 260 patients
eligible for mechanical thrombectomy in 11 French neurovascular
units and institutions of excellence.
The interim analysis, to be carried out after inclusion of the
first 78 patients will take place in the first half of 2024.
Governance
- Appointment of Patricia Zilliox to the Board of Directors as
an independent director
Patricia Zilliox has joined Acticor Biotech's Board of Directors
as an independent director, replacing Corinne Le Goff, whose
multiple directorships in the United States meant that she was no
longer able to fulfill her role with Acticor Biotech. This
appointment was ratified by the Annual General Meeting of
Shareholders on May 12, 2023.
Outlook
Acticor Biotech continues to develop its strategic plan to
demonstrate the efficacy of its drug glenzocimab and bring it to
registration for the treatment of stroke. The next clinical steps
in the treatment of cardiovascular emergencies are:
- ACTISAVE phase 2/3 study in stroke: final results expected
in Q2 2024.
- Phase 2b LIBERATE study in the treatment of myocardial
infarction: inclusion of the first patient is scheduled
before the end of 2023.
- Phase 2/3 GREEN study in stroke: an interim analysis
will be carried out after inclusion of the first 78 patients in
H1 2024.
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.
The positive results of the phase 1b/2a study, ACTIMIS,
confirmed the safety profile of glenzocimab and showed a reduction
in mortality and intracerebral hemorrhage in the
glenzocimab-treated group of stroke patients. The efficacy of
glenzocimab is now being evaluated in an international Phase 2/3
study, ACTISAVE, which will include 400 patients, with clinical
results expected in Q2 2024.
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 (Mediolanum farmaceutici, Karista, Go
Capital, Newton Biocapital, CMS Medical Venture Investment (HK)
Limited, A&B (HK) Limited, Anaxago, 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
Forward-looking statements
This press release contains forward-looking statements about
Acticor Biotech and its business. Acticor Biotech believes that
these forward-looking statements are based on reasonable
assumptions. However, there can be no assurance that the
expectations expressed in these forward-looking statements will
materialize as they are subject to risks, including those described
in the Registration Document as approved by the Autorité des
marchés financiers under number R. 22-011 on April 26, 2022, and to
changes in 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 that are
unknown to Acticor Biotech or that Acticor Biotech does not
currently consider material. The occurrence of some or all of these
risks could cause Acticor Biotech's actual results, financial
condition, performance or achievements to differ materially from
those expressed in the forward-looking statements.
Appendix
Income statement
in accordance with
IFRS
30/06/2023
30/06/2022
6 months
6 months
€’000
€’ 000
Research and development costs, net
(5,918)
(4,918)
Of which research and
development costs
(7,074)
(6,237)
Of which grants
1,156
1,320
Operating and administrative expenses
(2,093)
(1,917)
Costs relating to share-based payments
(810)
(435)
Other operating income and expenses
-
-
Operating income (loss)
(8,821)
(7,270)
Financial expenses
(1,734)
(40)
Financial income
474
1
Income (loss) before tax
(10,081)
(7,310)
Income tax
-
-
Net profit (loss) for the
period
(10,081)
(7,310)
Attributable to shareholders of the parent
company
(10,081)
(7,310)
Non-controlling interests
-
-
Weighted average number of shares in
circulation
11,631,540
10,545,776
Basic earnings per share (€/share)
(0.87)
(0.69)
Diluted earnings per share (€/share)
(0.87)
(0.69)
Statement of financial
position
in accordance with
IFRS
30/06/2023
31/12/2022
K€
K€
ASSETS
Intangible assets
713
713
Property, plant and equipment
28
14
Non-current financial assets
522
479
Total non-current assets
1,263
1,206
Other receivables
4,428
4,840
Prepaid expenses
656
298
Cash and cash equivalents
7,955
6,599
Total current assets
13,039
11,737
Total Assets
14,302
12,943
LIABILITIES AND EQUITY
Shareholders' equity
Share capital
617
527
Issue or contribution premiums
35,155
23,327
Other comprehensive income
(11)
(10)
Accumulated losses attributable to owners
of the Company
(25,312)
(10,209)
Net profit (loss) attributable to owners
of the Company
(10,081)
(15,878)
Equity attributable to owners of the
Company
368
(2,243)
Non-controlling interests
-
-
Total shareholders' equity
368
(2,243)
Non-current liabilities
Employee benefit obligations
85
56
Non-current borrowings
4,342
7,062
Non-current derivative liabilities
901
1,367
Provisions
-
-
Total non-current liabilities
5,328
8,485
Current liabilities
Current borrowings
2,706
801
Trade payables
5,265
5,141
Tax and social security liabilities
635
615
Other current liabilities
-
144
Total current liabilities
8,606
6,701
Total liabilities and equity
14,302
12,943
1 Net of research tax credit and grants.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231026846206/en/
ACTICOR BIOTECH Gilles AVENARD, MD General Manager and
founder gilles.avenard@acticor-biotech.com T. : +33 (0)6 76 23 38
13
Sophie BINAY, PhD Chief Operating Officer and Scientific
Director 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
Acticor Biotech (EU:ALACT)
Historical Stock Chart
From May 2024 to Jun 2024
Acticor Biotech (EU:ALACT)
Historical Stock Chart
From Jun 2023 to Jun 2024