from ACTICOR BIOTECH (isin : FR0014005OJ5)
Inside Information / News release on accounts, results
This replaces the announcement made at 17 :45 on October 31 because the following statement has been deleted: “The limited review procedures for the interim financial statements have been completed. The limited review report is in the process of being issued”.
• Repositioning of glenzocimab in the treatment of ST-segment elevation myocardial infarction (STEMI)
• Receivership proceedings: extension of the call for tenders for a continuation or sale plan until November 5, 2024
• Approval by shareholders of all resolutions at the Combined General Meeting on October 25, 2024
Paris, France, November 11, 2024 – 11:00am CET - ACTICOR BIOTECH (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, 2024, approved by the Board of Directors on October 23, 2024, and provides an update on its clinical developments.
The 2024 half-year financial report is available to the public on the Investors/Regulated Information section of the company's website.
Financial highlights (limited review - statutory accounts)
Given the Company's stage of clinical development, it does not generate revenues.
Research & Development costs[1] amounted to 4,244 thousand euros as of June 30, 2024, compared to 5,918 thousand euros as of June 30, 2023.
General and Administrative expenses totalled 2,692 thousand euros as of June 30, 2024, versus 2,093 thousand euros for the same period in 2023.
Operating loss reached 7,202 thousand euros for the first half of 2024, compared to 9,171 thousand euros in the same period of 2023.
As a result, the Company recorded a net loss of 7,305 thousand euros as of June 30, 2024, compared to 9,471 thousand euros as of June 30, 2023.
As of June 30, 2024, cash and cash equivalents amounted to 4,8 million euros, compared to 3.9 million euros as of December 31, 2023. As a reminder, on March 15, 2024, the Company raised 8 million euros
through a capital increase. On August 6, 2024, the Paris Commercial Court ordered the opening of receivership proceedings, enabling the Company to finance its operations until January 2025.
Clinical point: repositioning of glenzocimab in the treatment of myocardial infarction
On October 11, 2024, Acticor Biotech provided an update on its clinical developments, evaluating glenzocimab in the treatment of myocardial infarction.
As part of its clinical programme, Acticor Biotech is conducting the LIBERATE phase 2b study in partnership with the University of Birmingham to evaluate glenzocimab in the treatment of STsegment elevation myocardial infarction (STEMI). To date, 30 patients have been recruited, with results expected by the end of 2026. At the same time, the company is preparing the GLORIA study, a phase 2 study also targeting STEMI, to explore different doses and administration optimisations, with a view to a phase 3 study as early as 2027. Recruitment for GLORIA could begin in early 2025, subject to funding.
Receivership proceedings
On September 13 2024, the court-appointed administrator (administrateur judiciaire) has published an advertisement in the newspaper Les Echos seeking new investors to provide a restructuring plan (plan de continuation, articles L.626-1 et seq. of the French Commercial Code), or failing that, potential buyers for the business and assets of the Company (plan de cession, articles L.642-1 et seq. of the French Commercial Code). The court-appointed administrator has granted an extension of the invitation to tender until Tuesday 5 November 2024 at 12:00 pm.
Interested parties wishing to respond to the extended call for tenders are invited to express their interest by e-mail to the following addresses:
• Marine Pace: m.pace@aj-2m.com
• Roxane Brodin: r.brodin@aj-2m.com
For further information: acticor-biotech.com
As a reminder, on 6 August 2024, the Paris Commercial Court ordered the opening of receivership proceedings. The purpose of these proceedings is to enable the Company to assess all the options available to it to pursue its development, the development of its product, glenzocimab, and its search for financing and partners. This procedure will also enable the Company to finance its operations until January 2025.
Annual General Meeting
Shareholders present, represented or voting by post held 4,364,472 votes, giving a quorum of 28.19%. All the resolutions put to the vote at this Annual General Meeting were adopted, in particular the renewal of the appointments of the directors submitted to the vote.
The consolidated result of the vote by resolution and the report of the Annual General Meeting of October 25, 2024 will be available on the Company's website, in the Investors/ Shareholders' Meetingssection, within the legal deadlines.
About ACTICOR BIOTECH
ACTICOR BIOTECH, a clinical-stage biopharmaceutical company founded in 2013 from the work of INSERM, is developing glenzocimab, a humanized monoclonal antibody fragment (fab) targeting the GPVI platelet receptor for the treatment of cardiovascular emergencies and acute thrombotic diseases.
The main clinical indication being evaluated is acute ischemic stroke, due to the strong need for safer treatments, particularly those that do not increase the risk of bleeding, and its high incidence. In three international clinical trials involving over 600 stroke patients, no significant impact on neurological improvement (mRS score at 3 months) was demonstrated, with the exception of a sub-population of patients with intracerebral haemorrhage, where mortality was significantly reduced by a factor of 3 (p=0.035) (Mazighi et al. 2024).
LIBERATE, a Phase 2 clinical trial in the acute phase of myocardial infarction (STEMI), is currently being recruited through an academic partnership with the University of Birmingham (UK). This study aims to demonstrate the efficacy of glenzocimab in reducing the size of myocardial infarction, a critical factor for long-term cardiac function.
In all, more than 800 subjects were included in the clinical trials, over 400 of whom were exposed to glenzocimab without safety concerns.
The use of glenzocimab in thrombotic diseases is covered by 3 patent families, with an expiry date in 2036 for the first family. ACTICOR BIOTECH also has the right to develop a biomarker for stroke patients.
Acticor Biotech is backed 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) and has been listed on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 - ALACT). For further information, visit: www.acticor-biotech.com
Contacts
ACTICOR BIOTECH Gilles AVENARD, MD CEO and Founder gilles.avenard@acticor-biotech.com | NewCap Mathilde BOHIN 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 |
Sophie BINAY, PhD
General Manager and CSO
Sophie.binay@acticor-biotech.com
Disclaimer
This press release contains forward-looking statements with respect to Acticor Biotech and its business. Acticor Biotech believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in such forward-looking statements will prove to have been correct, as they are subject to risks, including those described in the Universal Registration Document as filed with the Autorité des marchés financiers on July 9, 2024, 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.
Appendices
Income statement | 30/06/2024 6 months K€ | 30/06/2023 6 months K€ |
Statutory | ||
Research and development costs, net Of which research and development costs |
|
(5,918) (7,074) |
(4,244) | ||
(4,249) | ||
Of which grants
Operating and administrative expenses Costs relating to share-based payments | 5
| 1,156
(2,093) (810) |
(2,692) | ||
(2) | ||
Other operating income and expenses (including CIR) | (264) | (350) |
Operating income (loss) | (7,202) | (9,171) |
Financial expenses | (240) | (308) |
Financial income | 137 | 8 |
Income (loss) before tax | (7,305) | (9,471) |
Income tax | ||
Net profit (loss) for the period | (7,305) | (9,471) |
Attributable to shareholders of the parent company | (7,305) | (9,471) |
Non-controlling interests | - | |
Weighted average number of shares in circulation | 15,755,227 | 11,631,540 |
Basic earnings per share (€/share) | (0.46) | (0.81) |
Diluted earnings per share (€/share) | (0.46) | (0.81) |
Statement of financial position | 30/06/2024 | 30/06/2023 | |
| K€ | K€ | |
ASSETS Intangible assets | 169 | 744 | |
Property, plant and equipment | 16 | 28 | |
Non-current financial assets | 392 | 522 | |
Total non-current assets | 577 |
| 1,294 |
Trade receivables and related accounts | - | - | |
Other receivables | 4,774 | 2,535 | |
Current financial assets | - | ||
Prepaid expenses | 57 | 656 | |
Cash and cash equivalents | 4,816 | 7,955 | |
Total current assets | 9,647 |
| 11,146 |
| |||
Total Assets | 10,224 | 12,440 | |
LIABILITIES AND EQUITY Shareholders' equity Share Capital |
788 |
617 | |
Additional paid-in capital | 45,350 | 35,209 | |
Other comprehensive income | - | - | |
Accumulated losses - attributable to shareholders of the parent | (27,256) | (27,256) | |
Net profit (loss) - attributable to equity holders of the parent | (24,171) | (9,471) | |
Equity attributable to shareholders of the parent company | (5,290) | (901) | |
Non-controlling interests | - | - | |
Total shareholders' equity | (5,290) | (901) | |
Non-current liabilities Obligations to employees |
- |
- | |
Non-current financial debts | 4,153 | 3,171 | |
Non-current derivative liabilities | - | - | |
Provisions | - | - | |
Non-current liabilities | 4,153 | 3,171 | |
Current liabilities Current financial debts |
3,092 |
3,192 | |
Trade payables | 7,358 | 6,347 | |
Social and fiscal debts | 911 | 631 | |
Other current liabilities | - | - | |
Total current liabilities | 11,361 | 10,170 | |
|
|
| |
Total liabilities and equity | 10,224 | 12,440 |