par ACTICOR BIOTECH (isin : FR0014005OJ5)
Inside Information / News release on accounts, results
• 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
Paris, France, July 9, 2024 – 6:00 CEST - 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 costs[1] 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.
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 Köhrmann (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).
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.
Annexes
Income statement in accordance with IFRS | Notes | 31/12/2023 12 mois | 31/12/2022 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
Weighted average number of shares in circulation (pro forma) |
|
| - | - | |
31/12/2023 | 31/12/2022 | ||||
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 K€ | 31/12/2022 K€ | ||
| |||||
ASSETS Intangible assets |
| - |
713 | ||
3 | |||||
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 Cash and cash equivalents | 6 7 | - 986 3,885 | - 298 6,599 | ||
Total current assets |
| 9,255 | 11,737 | ||
Total Assets | 9,716 | 12,943 | |||
LIABILITIES AND EQUITY Shareholders' equity Share Capital |
659 |
527 | |||
9 | |||||
Additional paid-in capital Other comprehensive income Accumulated losses - attributable to shareholders of the parent | 37,392 ,(31) (24,693) | 23,327 (10) (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 Non-current financial debts |
105 5,212 |
56 7,062 | |||
12 11 | |||||
Non-current derivative liabilities | 11 | 313 | 1,367 | ||
Provisions | 14 | - | - | ||
Total non-current liabilities | 5,630 | 8,485 | |||
Current liabilities Current financial debts Trade payables |
662 7,861 |
801 5,141 | |||
11 15 | |||||
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 K€ | 31/12/2022 K€ | ||
Cash flows from operating activities Net income for the period | 0 |
(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 Cash flow from operations before cost of net financial debt and taxes
(-) Change in working capital Taxes paid | 279 (15,574) (2,555) - | 325 (14,851) (2,748) - | ||
| ||||
| ||||
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 Cash and cash equivalents at end of year | 6,599 3,885 | 11,348 6,599 | ||
Increase (decrease) in cash | (2,714) | (4,749) |
Cash and cash equivalents (including bank overdrafts) |
- | ||
Cash and cash equivalents Current bank loans | - | ||
Cash and cash equivalents at the end of the year (including current bank loans) | 3,885 | 6,549 |
