ALACT Acticor Biotech

• Annual General Meeting to be held on September 13, 2024, to approve the financial statements for the year ending December 31, 2023

• Update on the glenzocimab clinical development plan published in June 2024: find the press release by clicking here

• Availability of the 2023 Universal Registration Document

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 2023 annual results, for the year ending December 31, 2023, approved by the Board of Directors on July 9, 2024.

Financial highlights (audited - prepared under IFRS)

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

Research & development costs1 amounted to 11,878 thousand euros at December 31, 2023, compared with 10,454 thousand euros at December 31, 2022.

Operating and administrative expenses amounted to 4,170 thousand euros at December 31, 2023, compared with 3,622 thousand euros at December 31, 2022.

The operating loss came to 17,565 thousand euros over the one-year period, compared with 15,121 thousand euros for the full year 2022.

As a result, the Company recorded a net loss of 18,640 thousand euros at December 31, 2023, compared with 12,608 thousand euros at December 31, 2022.

At December 31, 2023, cash and cash equivalents totalled €3.9 million, compared with €6.6 million at December 31, 2022.

On March 15, 2024, the Company announced the completion of an €8 million capital raising.

On the basis of planned expenditure, net cash balance and net financial debt at December 31, 2023 of €3.9 million and €1.0 million respectively, and the funds raised through the capital increase, the Company estimates that it will be able to finance its operations until September 2024. The Company continues to actively study various solutions for financing its business and development. These solutions could, without being restrictive, take the form of private placements with existing investors, a public offering or private placements with new investors, or the issue of bonds.

The Company's financing requirements up to June 30, 2025, are estimated at €8 million, with no further new clinical studies to be initiated by Acticor. At the balance sheet date, the Company's management considers that it has reasonable assurance of finding adequate financing but cannot guarantee that it will be able to obtain it on acceptable terms, and that, as a result, there is significant uncertainty as to the Company's ability to continue as a going concern.

Annual General Meeting

In accordance with its articles of association, Acticor Biotech closed its financial year on December 31, 2023.

By order of June 19, 2024, the President of the Paris Commercial Court, with whom the petition was filed, extended the deadline for the Annual General Meeting to October 31, 2024.

The Company informs its shareholders that the Annual General Meeting called to approve the financial statements for the year ended December 31, 2023, will be held on September 13, 2024.

Clinical update

On June 3, 2024, Acticor Biotech provided an update on the clinical development plan for glenzocimab in the treatment of cardiovascular emergencies.

> Read the press release HERE

The Company is actively continuing discussions with pharmaceutical partners to explore strategic collaborations that could support glenzocimab's development, and thus secure the financial resources beyond September 2024 needed to continue operations.

Availability of the 2023 Universal Registration Document

The Universal Registration Document 2023, filed with the French Financial Markets Authority (AMF) on July 9, 2024, is available to the public free of charge in accordance with current regulations, and can be consulted on the Company's website (Investors / Regulated information / Financial information / 2024), as well as on that of the AMF (www.amf-france.org).

This Universal Registration Document includes the annual financial report, the management report, the corporate governance report, information on the fees paid to the Statutory Auditors, and the Statutory Auditors' reports.

About ACTICOR BIOTECH

Acticor Biotech is a clinical-stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, particularly ischemic stroke.

The positive results of the phase 1b/2a study, ACTIMIS, published in January 2024 in the Lancet Neurology (link to publication) confirmed the safety profile of glenzocimab and showed a reduction in mortality and intracerebral hemorrhage in the glenzocimab-treated group of stroke patients. A post-hoc analysis of brain imaging at 0 and 24 hours using artificial intelligence confirmed these results, showing a reduction in the number and volume of intracerebral lesions in patients treated with glenzocimab.

On April 25, 2024, the company announced the initial results of the international phase 2/3 ACTISAVE study in the treatment of acute ischemic stroke, which showed no efficacy of glenzocimab on the primary endpoint, the proportion of patients with severe disability or death (mRS 4-6) 90 days after stroke, nor on the secondary endpoint, the proportion of patients returning to life without disability (mRS 0-2).

On May 15, 2024, Prof. Mikael K�hrmann (Principal Investigator of ACTISAVE) presented the main results of the study at the opening session of the European Stroke Organization Conference (ESOC), confirming the neutrality of the study on the primary and secondary endpoints, and showing trends in return to normal life (mRS 0-1), notably in sub-populations of patients with complete recanalization after mechanical thrombectomy.

Glenzocimab is being evaluated in 2 other clinical trials initiated by academic teams:

• GREEN: a phase 2/3 study in the treatment of stroke in thrombectomized patients, with a futility analysis after inclusion of the first 78 patients (30% of patients) expected in Q4 2024;
• LIBERATE: a Phase 2b LIBERATE trial in the treatment of myocardial infarction, with final results expected in Q4 2025.

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) and has been listed on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 - ALACT).

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.

Annexes

Income statement in accordance with IFRS

Notes

31/12/2023

31/12/2022

12 mois

12 mois

K€

K€

 

Research and development costs, net

17.1

(11,878)

(10,454)

Of which research and development costs

17.1

(14,490)

(13,132)

Of which grants

17.1

2,612

2,678

 

 

 

 

 

 

Operating and administrative expenses

17.2

(4,170)

(3,622)

 

 

 

 

 

 

Costs relating to share-based payments

10

(1,517)

(1,045)

 

 

 

 

 

 

Operating income (loss)

(17,565)

(15,121)

 

Financial expenses

18

(2,144)

(766)

Financial income

18

1,069

8

Income (loss) before tax

(18,640)

(15,878)

 

 

 

Income tax

19

-

-

Net profit (loss) for the period

(18,640)

(15,878)

 

Attributable to shareholders of the parent company

(18,640)

(15,878)

Non-controlling interests

-

-

 

31/12/2023

31/12/2022

Weighted average number of shares in circulation (pro forma)

12,068,476

10,545,776

Basic earnings per share (€/share)

20

(1.54)

(1.51)

Diluted earnings per share (€/share)

20

(1.54)

(1.51)

Statement of financial position in accordance with IFRS

Notes

 

31/12/2023

 

31/12/2022

 

 

 

K€

 

K€

ASSETS

 

 

 

 

 

 

 

Intangible assets

3

 

-

 

713

Property, plant and equipment

4

 

22

 

14

Non-current financial assets

5

 

439

 

479

Total non-current assets

 

 

461

 

1,206

 

 

 

 

Trade receivables and related accounts

 

-

 

-

Other receivables

6

 

4,384

 

4,840

Current financial assets

 

 

-

 

-

Prepaid expenses

6

 

986

 

298

Cash and cash equivalents

7

 

3,885

 

6,599

Total current assets

 

 

9,255

 

11,737

 

 

 

 

Total Assets

 

 

9,716

 

12,943

 

 

 

 

 

 

LIABILITIES AND EQUITY

 

 

 

 

 

Shareholders' equity

 

 

 

 

 

Share Capital

9

 

659

 

527

Additional paid-in capital

 

 

37,392

 

23,327

Other comprehensive income

 

 

(31)

 

(10)

Accumulated losses - attributable to shareholders of the parent

 

 

(24,693)

 

(10,209)

Net profit (loss) - attributable to equity holders of the parent

 

 

(18,640)

 

(15,878)

Equity attributable to shareholders of the parent company

 

 

(5,313)

 

(2,243)

Non-controlling interests

 

 

-

 

-

Total shareholders' equity

 

 

(5,313)

 

(2,243)

 

 

 

 

 

 

Non-current liabilities

 

 

 

 

 

Obligations to employees

12

 

105

 

56

Non-current financial debts

11

 

5,212

 

7,062

Non-current derivative liabilities

11

 

313

 

1,367

Provisions

14

 

-

 

-

Total non-current liabilities

 

 

5,630

 

8,485

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

Current financial debts

11

 

662

 

801

Trade payables

15

 

7,861

 

5,141

Social and fiscal debts

15

 

875

 

615

Other current liabilities

15

 

-

 

144

Total current liabilities

 

 

9,398

 

6,701

 

 

 

 

 

 

Total liabilities and equity

 

 

9,716

 

12,943

Statement of cash flows in accordance with IFRS

 

31/12/2023

 

31/12/2022

 

 

K€

 

K€

 

Cash flows from operating activities

 

Net income for the period

 

(18,640)

(15,878)

(-) Elimination of amortization and impairment of intangible assets

 

(713)

 

-

(-) Elimination of depreciation on property, plant and equipment

 

(15)

(86)

(-) Unrealized foreign exchange gains and losses

 

(2)

-

(-) Provision for pension obligations

 

(28)

(25)

(-) Provision for risks and charges

 

-

559

(-) Share-based payment expense

 

(1,517)

(1,045)

(-) Gain (loss) on disposal of fixed assets

 

3

 

3

(-) Elimination of the cost of net financial debt

 

(1,072)

 

(758)

(-) Elimination of subsidy on repayable advances

 

279

 

325

Cash flow from operations before cost of net financial debt and taxes

(15,574)

(14,851)

 

 

(-) Change in working capital

 

(2,555)

(2,748)

 

Taxes paid

-

-

 

 

Cash flows from operating activities

 

(13,019)

(12,104)

 

 

Cash flows from investing activities

 

 

Acquisition of property, plant and equipment

 

(20)

(6)

Acquisition of financial assets

 

(29)

 

(66)

Reduction of financial assets

 

-

 

6

Disposal price of assets sold

 

3

 

-

Interest earned on term deposits

 

-

-

Cash flows from investing activities

 

(46)

(66)

 

 

Cash flows from financing activities

 

 

Capital increase

 

10,109

-

Capital increase costs

 

-

 

-

Subscription of warrants

 

-

8

Issuance of simple and convertible bonds

 

-

5,900

Gross financial interests paid

 

(345)

 

(109)

Collection of advances

 

1,326

 

2,028

Repayment of advances

 

(365)

 

(293)

Issuance of a bank loan

 

-

 

-

Repayment of bank loan

 

(366)

 

(67)

Decrease in financial debt related to lease obligations

 

-

(46)

Payment into the liquidity contract

 

-

 

-

 

 

 

 

 

Cash flows from financing activities

 

10,359

7,421

 

 

Increase (decrease) in cash

 

(2,707)

(4,749)

 

 

Cash and cash equivalents at beginning of year

 

6,599

11,348

Cash and cash equivalents at end of year

 

3,885

6,599

 

 

Increase (decrease) in cash

 

(2,714)

(4,749)

 

 

Cash and cash equivalents (including bank overdrafts)

 

31/12/2023

31/12/2022

Cash and cash equivalents

 

3,885

6,549

Current bank loans

 

-

-

Cash and cash equivalents at the end of the year (including current bank loans)

 

3,885

6,549

1 Net of research tax credit and subsidies.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240709616755/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