ALACT Acticor Biotech

• 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

Regulatory News:

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. The limited review procedures on the interim financial statements have been performed. The limited review report is in the process of being issued.

Financial highlights (limited review - statutory accounts)

Given the Company's stage of clinical development, it does not generate revenues.

Research & Development costs1 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 ST-segment 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' Meetings section, 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

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

30/06/2023

Statutory

6 months

6 months

 

K€

K€

 

Research and development costs, net

 (4,244)

(5,918)

Of which research and development costs

 (4,249)

(7,074)

Of which grants

5

1,156

Operating and administrative expenses

(2,692)

(2,093)

Costs relating to share-based payments

(2)

(810)

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

____________________________ 1 Net of research tax credit and grants.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241031547113/en/

ACTICOR BIOTECH Gilles AVENARD, MD CEO and Founder gilles.avenard@acticor-biotech.com

Sophie BINAY, PhD General Manager and CSO Sophie.binay@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