UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF
1934
August 2023
Commission File Number: 001-39179
Addex Therapeutics Ltd
(Exact Name of Registrant as Specified in
Its Charter)
Chemin des Mines 9,
CH-1202 Geneva,
Switzerland
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will
file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F
x Form 40-F o
INCORPORATION BY REFERENCE
Exhibits 99.1 and 99.2 to this Report on Form 6-K shall be deemed
to be incorporated by reference into the registration statement on Form F-3 (Registration No. 333-255089) of Addex Therapeutics
Ltd and the registration statement on Form S-8 (Registration No. 333-255124 and No. 333-272515) of Addex Therapeutics Ltd
(including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report
is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
RISK FACTORS
Our business faces significant risks. You should carefully consider
all of the information set forth in this Report on Form 6-K and in our other filings with the United States Securities and Exchange
Commission, or the SEC, including the risk factors related to our business set forth in our Annual Report on Form 20-F for the
year ended December 31, 2022 filed with the Securities and Exchange Commission on March 30, 2023 and updated in our prospectus
(No.333-271611) filed on June 2, 2023. Our business, financial condition, results of operations and growth prospects could be materially
adversely affected by any of these risks. This report also contains forward-looking statements that involve risks and uncertainties. Our
results could materially differ from those anticipated in these forward-looking statements, as a result of certain factors including the
risks described in our Annual Report and our other SEC filings.
SIGNATURE
Pursuant to the requirements of
the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
|
Addex Therapeutics Ltd |
|
|
|
By: |
/s/
Tim Dyer |
|
|
Name: |
Tim Dyer |
Date: August 10, 2023 |
|
Title: |
Chief Executive Officer |
EXHIBIT INDEX
Exhibit 99.1
ADDEX THERAPEUTICS LTD
INDEX TO UNAUDITED INTERIM CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
Unaudited Interim Condensed Consolidated Financial Statements |
|
Unaudited Interim Condensed Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022 |
2 |
Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss for the three-month and six-month periods ended June 30, 2023 and 2022 |
3 |
Unaudited Interim Condensed Consolidated Statements of Changes in Equity for the six-month period ended June 30, 2023 and 2022 |
4 |
Unaudited Interim Condensed Consolidated Statements of Changes in Equity for the three-month period ended June 30, 2022 |
5 |
Unaudited Interim Condensed Consolidated Statements of Changes in Equity for the three-month period ended June 30, 2023 |
6 |
Unaudited Interim Condensed Consolidated Statements of Cash Flows for the six-month periods ended June 30, 2022 and 2023 |
7 |
Unaudited Notes to the Interim Condensed Consolidated Financial Statements for the three-month and six-month periods ended June 30, 2023 |
8 |
Addex
Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements
Unaudited Interim Condensed Consolidated Balance
Sheets
as of June 30, 2023, and December 31,
2022
| |
Notes | |
June 30, 2023 | | |
December 31,
2022 | |
| |
| |
| | |
| |
| |
| |
Amounts
in Swiss francs | |
ASSETS | |
| |
| | | |
| | |
| |
| |
| | | |
| | |
Current assets | |
| |
| | | |
| | |
Cash and cash equivalents | |
6 | |
| 7,169,069 | | |
| 6,957,086 | |
Other financial assets | |
7/12 | |
| 16,744 | | |
| 3,165 | |
Trade and other receivables | |
7 | |
| 255,656 | | |
| 416,875 | |
Contract asset | |
7 | |
| 246,626 | | |
| 181,441 | |
Prepayments | |
7 | |
| 1,003,491 | | |
| 270,394 | |
Total current assets | |
| |
| 8,691,586 | | |
| 7,828,961 | |
| |
| |
| | | |
| | |
Non-current assets | |
| |
| | | |
| | |
Right-of-use assets | |
8 | |
| 219,353 | | |
| 357,613 | |
Property, plant and equipment | |
9 | |
| 33,154 | | |
| 41,121 | |
Non-current financial assets | |
10 | |
| 54,350 | | |
| 54,355 | |
Total non-current assets | |
| |
| 306,857 | | |
| 453,089 | |
| |
| |
| | | |
| | |
Total assets | |
| |
| 8,998,443 | | |
| 8,282,050 | |
| |
| |
| | | |
| | |
LIABILITIES AND EQUITY | |
| |
| | | |
| | |
| |
| |
| | | |
| | |
Current liabilities | |
| |
| | | |
| | |
Current lease liabilities | |
| |
| 199,884 | | |
| 286,107 | |
Payables and accruals | |
11 | |
| 2,513,958 | | |
| 2,996,004 | |
Total current liabilities | |
| |
| 2,713,842 | | |
| 3,282,111 | |
| |
| |
| | | |
| | |
Non-current liabilities | |
| |
| | | |
| | |
Non-current lease liabilities | |
| |
| 32,635 | | |
| 87,028 | |
Retirement benefits obligations | |
14 | |
| 125,863 | | |
| - | |
Total non-current liabilities | |
| |
| 158,498 | | |
| 87,028 | |
| |
| |
| | | |
| | |
Equity | |
| |
| | | |
| | |
Share capital | |
12 | |
| 1,364,513 | | |
| 1,153,483 | |
Share premium | |
12 | |
| 263,658,917 | | |
| 269,511,610 | |
Other equity | |
12 | |
| 64,620,223 | | |
| 64,620,223 | |
Treasury shares reserve | |
12 | |
| (636,188 | ) | |
| (6,278,763 | ) |
Other reserves | |
| |
| 32,062,974 | | |
| 25,768,373 | |
Accumulated deficit | |
| |
| (354,944,336 | ) | |
| (349,862,015 | ) |
Total equity | |
| |
| 6,126,103 | | |
| 4,912,911 | |
| |
| |
| | | |
| | |
Total liabilities and equity | |
| |
| 8,998,443 | | |
| 8,282,050 | |
The accompanying notes form an integral part of
these consolidated financial statements.
Addex
Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements
Unaudited Interim Condensed Consolidated Statements
of Comprehensive Loss
for the three-month and six-month periods ended
June 30, 2023 and 2022
| |
| |
For the three months ended
June 30, | | |
For the six months ended
June 30, | |
| |
Notes | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| |
| | |
| | |
| | |
| |
| |
Amounts in Swiss francs | |
Revenue from contract with customer | |
15 | |
| 630,877 | | |
| 183,354 | | |
| 1,131,769 | | |
| 420,591 | |
Other income | |
16 | |
| 1,100 | | |
| 3,089 | | |
| 2,255 | | |
| 9,800 | |
| |
| |
| | | |
| | | |
| | | |
| | |
Operating costs | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
| |
| (1,875,088 | ) | |
| (5,747,026 | ) | |
| (3,579,063 | ) | |
| (9,512,473 | ) |
General and administration | |
| |
| (1,303,665 | ) | |
| (1,531,632 | ) | |
| (2,501,242 | ) | |
| (3,772,718 | ) |
Total operating costs | |
17 | |
| (3,178,753 | ) | |
| (7,278,658 | ) | |
| (6,080,305 | ) | |
| (13,285,191 | ) |
| |
| |
| | | |
| | | |
| | | |
| | |
Operating loss | |
| |
| (2,546,776 | ) | |
| (7,092,215 | ) | |
| (4,946,281 | ) | |
| (12,854,800 | ) |
| |
| |
| | | |
| | | |
| | | |
| | |
Finance income | |
| |
| 13,349 | | |
| 205 | | |
| 37,175 | | |
| 300 | |
Finance expense | |
| |
| (141,725 | ) | |
| (129,242 | ) | |
| (173,215 | ) | |
| (190,487 | ) |
Finance result | |
19 | |
| (128,376 | ) | |
| (129,037 | ) | |
| (136,040 | ) | |
| (190,187 | ) |
| |
| |
| | | |
| | | |
| | | |
| | |
Net loss before tax | |
| |
| (2,675,152 | ) | |
| (7,221,252 | ) | |
| (5,082,321 | ) | |
| (13,044,987 | ) |
Income tax expense | |
| |
| - | | |
| - | | |
| - | | |
| - | |
Net loss for the period | |
| |
| (2,675,152 | ) | |
| (7,221,252 | ) | |
| (5,082,321 | ) | |
| (13,044,987 | ) |
| |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share for loss attributable to the ordinary equity holders of the Company | |
20 | |
| (0.04 | ) | |
| (0.19 | ) | |
| (0.08 | ) | |
| (0.34 | ) |
| |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive (loss)/ income | |
| |
| | | |
| | | |
| | | |
| | |
Items that will never be reclassified to profit and loss: | |
| |
| | | |
| | | |
| | | |
| | |
Remeasurements of retirement benefits obligation | |
| |
| (135,012 | ) | |
| 478,949 | | |
| (165,653 | ) | |
| 1,144,768 | |
Items that may be classified subsequently to profit and loss: | |
| |
| | | |
| | | |
| | | |
| | |
Exchange difference on translation of foreign operations | |
| |
| (979 | ) | |
| 208 | | |
| (898 | ) | |
| 235 | |
Other comprehensive (loss)/income for the period, net of tax | |
| |
| (135,991 | ) | |
| 479,157 | | |
| (166,551 | ) | |
| 1,145,003 | |
| |
| |
| | | |
| | | |
| | | |
| | |
Total comprehensive loss for the period | |
| |
| (2,811,143 | ) | |
| (6,742,095 | ) | |
| (5,248,872 | ) | |
| (11,899,984 | ) |
The accompanying notes form an integral part of
these consolidated financial statements.
Addex
Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements
Unaudited Interim Condensed Consolidated Statements
of Changes in Equity
for the six-month periods ended June 30,
2023 and 2022
| |
Notes | | |
Share
Capital | | |
Share
Premium | | |
Other
Equity | | |
Treasury
Shares Reserve | | |
Foreign
Currency Translation Reserve | | |
Other
Reserves | | |
Accumulated
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
|
|
Amounts in Swiss francs |
Balance
as of January 1, 2022 | |
| | |
| 49,272,952 | | |
| 283,981,361 | | |
| - | | |
| (11,703,279 | ) | |
| (657,525 | ) | |
| 25,095,393 | | |
| (329,057,802 | ) | |
| 16,931,100 | |
Net loss for the period | |
| | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (13,044,987 | ) | |
| (13,044,987 | ) |
Other comprehensive
income for the period | |
| | |
| - | | |
| - | | |
| - | | |
| - | | |
| 235 | | |
| 1,144,768 | | |
| - | | |
| 1,145,003 | |
Total comprehensive loss
for the period | |
| | |
| - | | |
| - | | |
| - | | |
| - | | |
| 235 | | |
| 1,144,768 | | |
| (13,044,987 | ) | |
| (11,899,984 | ) |
Issue of treasury shares | |
12 | | |
| 16,000,000 | | |
| - | | |
| - | | |
| (16,000,000 | ) | |
| - | | |
| - | | |
| - | | |
| - | |
Cost of treasury shares issuance | |
| | |
| - | | |
| (215,633 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (215,633 | ) |
Related costs of sales shelf-registration | |
| | |
| - | | |
| (2,223 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,223 | ) |
Cost of pre-funded warrants
sold | |
| | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (36,534 | ) | |
| - | | |
| (36,534 | ) |
Value of share-based services | |
13 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 2,099,311 | | |
| - | | |
| 2,099,311 | |
Movement in treasury shares: | |
12 | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net purchases
under liquidity agreement | |
| | |
| - | | |
| (47,042 | ) | |
| - | | |
| 33,457 | | |
| - | | |
| - | | |
| - | | |
| (13,585 | ) |
Balance as of June 30,
2022 | |
| | |
| 65,272,952 | | |
| 283,716,463 | | |
| - | | |
| (27,669,822 | ) | |
| (657,290 | ) | |
| 28,302,938 | | |
| (342,102,789 | ) | |
| 6,862,452 | |
| |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as of January 1,
2023 | |
| | |
| 1,153,483 | | |
| 269,511,610 | | |
| 64,620,223 | | |
| (6,278,763 | ) | |
| (657,870 | ) | |
| 26,426,243 | | |
| (349,862,015 | ) | |
| 4,912,911 | |
Net loss for the period | |
| | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,082,321 | ) | |
| (5,082,321 | ) |
Other comprehensive
loss for the period | |
| | |
| - | | |
| - | | |
| - | | |
| - | | |
| (898 | ) | |
| (165,653 | ) | |
| - | | |
| (166,551 | ) |
Total comprehensive loss
for the period | |
| | |
| - | | |
| - | | |
| - | | |
| - | | |
| (898 | ) | |
| (165,653 | ) | |
| (5,082,321 | ) | |
| (5,248,872 | ) |
Issue of treasury shares | |
12 | | |
| 176,000 | | |
| - | | |
| - | | |
| (176,000 | ) | |
| - | | |
| - | | |
| - | | |
| - | |
Cost of treasury shares issuance | |
| | |
| - | | |
| (16,823 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (16,823 | ) |
Sales under shelf registration | |
12 | | |
| - | | |
| (920,069 | ) | |
| - | | |
| 2,079,828 | | |
| - | | |
| - | | |
| - | | |
| 1,159,759 | |
Related costs of sales shelf-registration | |
| | |
| - | | |
| (34,106 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (34,106 | ) |
Sale of pre-funded warrants | |
12 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 3,382,259 | | |
| - | | |
| 3,382,259 | |
Cost of pre-funded warrants
sold | |
| | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (118,117 | ) | |
| - | | |
| (118,117 | ) |
Exercise of pre-funded warrants | |
12 | | |
| 35,030 | | |
| 449,939 | | |
| - | | |
| - | | |
| - | | |
| (484,930 | ) | |
| - | | |
| 39 | |
Value of warrants and pre-funded
warrants | |
12 | | |
| - | | |
| (2,760,143 | ) | |
| - | | |
| - | | |
| - | | |
| 2,760,143 | | |
| - | | |
| - | |
Value of share-based services | |
13 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 921,797 | | |
| - | | |
| 921,797 | |
Movement in treasury shares: | |
12 | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net purchases under liquidity
agreement | |
| | |
| - | | |
| 2,183 | | |
| - | | |
| (2,882 | ) | |
| - | | |
| - | | |
| - | | |
| (699 | ) |
Sales agency agreement | |
| | |
| - | | |
| (2,565,725 | ) | |
| - | | |
| 3,742,506 | | |
| - | | |
| - | | |
| - | | |
| 1,176,781 | |
Costs under
sale agency agreement | |
| | |
| - | | |
| (8,826 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8,826 | ) |
Balance as of June 30,
2023 | |
| | |
| 1,364,513 | | |
| 263,658,040 | | |
| 64,620,223 | | |
| (635,311 | ) | |
| (658,768 | ) | |
| 32,721,742 | | |
| (354,944,336 | ) | |
| 6,126,103 | |
The accompanying notes form an integral part of
these consolidated financial statements.
Addex
Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements
Unaudited Interim Condensed Consolidated Statements
of Changes in Equity
for the three-month period ended June 30,
2022
|
|
Notes |
|
Share
Capital |
|
|
Share
Premium |
|
|
Treasury
Shares
Reserve |
|
|
Foreign
Currency
Translation
Reserve |
|
|
Other
Reserves |
|
|
Accumulated
Deficit |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts in Swiss francs |
Balance as
of January 1, 2022 |
|
|
|
|
49,272,952 |
|
|
|
283,981,361 |
|
|
|
(11,703,279 |
) |
|
|
(657,525 |
) |
|
|
25,095,393 |
|
|
|
(329,057,802 |
) |
|
|
16,931,100 |
|
Net loss for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5,823,735 |
) |
|
|
(5,823,735 |
) |
Other
comprehensive income for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
27 |
|
|
|
665,819 |
|
|
|
- |
|
|
|
665,846 |
|
Total comprehensive loss
for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
27 |
|
|
|
665,819 |
|
|
|
(5,823,735 |
) |
|
|
(5,157,889 |
) |
Issue of treasury shares |
|
12 |
|
|
16,000,000 |
|
|
|
- |
|
|
|
(16,000,000 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Cost of treasury shares issuance |
|
|
|
|
- |
|
|
|
(210,633 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(210,633 |
) |
Related costs of sales shelf
registration |
|
|
|
|
- |
|
|
|
(2,223 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,223 |
) |
Cost of pre-funded warrants
sold |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(36,534 |
) |
|
|
- |
|
|
|
(36,534 |
) |
Value of share-based services |
|
13 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,440,052 |
|
|
|
- |
|
|
|
1,440,052 |
|
Movement in treasury shares: |
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net purchases
under liquidity agreement |
|
|
|
|
- |
|
|
|
(26,252 |
) |
|
|
17,692 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(8,560 |
) |
Balance as of March 31,
2022 |
|
|
|
|
65,272,952 |
|
|
|
283,742,253 |
|
|
|
(27,685,587 |
) |
|
|
(657,498 |
) |
|
|
27,164,730 |
|
|
|
(334,881,537 |
) |
|
|
12,955,313 |
|
Net loss for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(7,221,252 |
) |
|
|
(7,221,252 |
) |
Other
comprehensive income for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
208 |
|
|
|
478,949 |
|
|
|
- |
|
|
|
479,157 |
|
Total comprehensive loss
for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
208 |
|
|
|
478,949 |
|
|
|
(7,221,252 |
) |
|
|
(6,742,095 |
) |
Cost of treasury shares issuance |
|
|
|
|
- |
|
|
|
(5,000 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5,000 |
) |
Value of share-based services |
|
13 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
659,259 |
|
|
|
- |
|
|
|
659,259 |
|
Movement in treasury shares: |
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net purchases
under liquidity agreement |
|
|
|
|
- |
|
|
|
(20,790 |
) |
|
|
15,765 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5,025 |
) |
Balance as of June 30,
2022 |
|
|
|
|
65,272,952 |
|
|
|
283,716,463 |
|
|
|
(27,669,822 |
) |
|
|
(657,290 |
) |
|
|
28,302,938 |
|
|
|
(342,102,789 |
) |
|
|
6,862,452 |
|
The accompanying notes form an integral part of
these consolidated financial statements.
Addex
Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements
Unaudited Interim Condensed Consolidated Statements
of Changes in Equity
for the three-month period ended June 30,
2023
| |
Notes | | |
Share
Capital | | |
Share
Premium | | |
Other Equity | | |
Treasury
Shares
Reserve | | |
Foreign
Currency
Translation
Reserve | | |
Other
Reserves | | |
Accumulated
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| |
| Amounts
in Swiss francs | |
Balance
as of January 1, 2023 | |
| | | |
| 1,153,483 | | |
| 269,511,610 | | |
| 64,620,223 | | |
| (6,278,763 | ) | |
| (657,870 | ) | |
| 26,426,243 | | |
| (349,862,015 | ) | |
| 4,912,911 | |
Net loss for the period | |
| | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,407,169 | ) | |
| (2,407,169 | ) |
Other comprehensive
loss for the period | |
| | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 81 | | |
| (30,641 | ) | |
| - | | |
| (30,560 | ) |
Total comprehensive loss
for the period | |
| | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 81 | | |
| (30,641 | ) | |
| (2,407,169 | ) | |
| (2,437,729 | ) |
Cost of shares issuance | |
| | | |
| - | | |
| (4,062 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,062 | ) |
Value of share-based services | |
| 13 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 431,196 | | |
| - | | |
| 431,196 | |
Movement in treasury shares: | |
| 12 | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net purchases under liquidity
agreement | |
| | | |
| - | | |
| 12,775 | | |
| - | | |
| (11,818 | ) | |
| - | | |
| - | | |
| - | | |
| 957 | |
Sales agency agreement | |
| | | |
| - | | |
| (2,565,725 | ) | |
| - | | |
| 3,742,506 | | |
| - | | |
| - | | |
| - | | |
| 1,176,781 | |
Costs under
sale agency agreement | |
| | | |
| - | | |
| (8,826 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8,826 | ) |
Balance as of March 31,
2023 | |
| | | |
| 1,153,483 | | |
| 266,945,772 | | |
| 64,620,223 | | |
| (2,548,075 | ) | |
| (657,789 | ) | |
| 26,826,798 | | |
| (352,269,184 | ) | |
| 4,071,228 | |
Net loss for the period | |
| | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,675,152 | ) | |
| (2,675,152 | ) |
Other comprehensive
loss for the period | |
| | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (979 | ) | |
| (135,012 | ) | |
| - | | |
| (135,991 | ) |
Total
comprehensive loss for the period | |
| | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (979 | ) | |
| (135,012 | ) | |
| (2,675,152 | ) | |
| (2,811,143 | ) |
Issue of treasury shares | |
| | | |
| 176,000 | | |
| - | | |
| - | | |
| (176,000 | ) | |
| - | | |
| - | | |
| - | | |
| - | |
Cost of treasury shares issuance | |
| | | |
| - | | |
| (12,761 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (12,761 | ) |
Sales under shelf registration | |
| 12 | | |
| - | | |
| (920,069 | ) | |
| - | | |
| 2,079,828 | | |
| - | | |
| - | | |
| - | | |
| 1,159,759 | |
Related costs of sales shelf-registration | |
| | | |
| - | | |
| (34,106 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (34,106 | ) |
Sale of pre-funded warrants | |
| 12 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 3,382,259 | | |
| - | | |
| 3,382,259 | |
Cost of pre-funded warrants sold | |
| | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (118,117 | ) | |
| - | | |
| (118,117 | ) |
Exercise of pre-funded warrants | |
| 12 | | |
| 35,030 | | |
| 449,939 | | |
| - | | |
| - | | |
| - | | |
| (484,930 | ) | |
| - | | |
| 39 | |
Value of warrants and pre-funded
warrants | |
| 12 | | |
| - | | |
| (2,760,143 | ) | |
| - | | |
| - | | |
| - | | |
| 2,760,143 | | |
| - | | |
| - | |
Value of share-based services | |
| 13 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 490,601 | | |
| - | | |
| 490,601 | |
Movement in treasury shares: | |
| 12 | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net purchases
under liquidity agreement | |
| | | |
| - | | |
| (10,592 | ) | |
| - | | |
| 8,936 | | |
| - | | |
| - | | |
| - | | |
| (1,656 | ) |
Balance
as of June 30, 2023 | |
| | | |
| 1,364,513 | | |
| 263,658,040 | | |
| 64,620,223 | | |
| (635,311 | ) | |
| (658,768 | ) | |
| 32,721,742 | | |
| (354,944,336 | ) | |
| 6,126,103 | |
The accompanying notes form an integral part of
these consolidated financial statements.
Addex
Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements
Unaudited Interim Condensed Consolidated Statements
of Cash Flows
for the six-month periods ended June 30,
2023 and 2022
| |
| | |
For the six months ended
June 30, | |
| |
Notes | | |
2023 | | |
2022 | |
| |
| | |
| | |
| |
| |
|
|
|
Amounts
in Swiss francs | |
Net loss for the period | |
| | |
| (5,082,321 | ) | |
| (13,044,987 | ) |
Adjustments for: | |
| | |
| | | |
| | |
Depreciation | |
8/9 | | |
| 151,186 | | |
| 170,178 | |
Value of share-based services | |
13 | | |
| 921,797 | | |
| 2,099,311 | |
Post-employment benefits | |
| | |
| (39,790 | ) | |
| (7,481 | ) |
Finance cost net | |
| | |
| 149,386 | | |
| 116,981 | |
(Increase)/ decrease in other financial assets | |
7 | | |
| (13,579 | ) | |
| 13,584 | |
Decrease / (increase) in trade and other receivables | |
7 | | |
| 161,220 | | |
| (166,985 | ) |
(Increase)/ decrease in contract asset | |
7 | | |
| (65,185 | ) | |
| 81,383 | |
Increase in prepayments | |
7 | | |
| (733,097 | ) | |
| (604,319 | ) |
(Decrease)/increase in payables and accruals | |
11 | | |
| (566,878 | ) | |
| 667,430 | |
Net cash used in operating activities | |
| | |
| (5,117,261 | ) | |
| (10,674,905 | ) |
| |
| | |
| | | |
| | |
Cash flows from investing activities | |
| | |
| | | |
| | |
Purchase of property, plant and equipment | |
9 | | |
| (4,959 | ) | |
| - | |
Net cash used in investing activities | |
| | |
| (4,959 | ) | |
| - | |
| |
| | |
| | | |
| | |
Cash flows from financing activities | |
| | |
| | | |
| | |
Proceeds from sale of treasury shares – shelf registration | |
12 | | |
| 1,159,759 | | |
| - | |
Costs paid on sale of treasury shares – shelf registration | |
12 | | |
| (17,588 | ) | |
| (193,834 | ) |
Proceeds from sale of pre-funded warrants | |
12 | | |
| 3,382,259 | | |
| - | |
Costs paid on sale of pre-funded warrants | |
12 | | |
| (26,333 | ) | |
| (306,127 | ) |
Proceeds from the exercise of pre-funded warrants | |
12 | | |
| 5,345 | | |
| - | |
Sale/(purchase) of treasury shares under liquidity and sale under agency agreement | |
12 | | |
| 1,176,082 | | |
| (13,585 | ) |
Costs paid on sale of treasury shares under sale agency agreement | |
| | |
| (8,826 | ) | |
| - | |
Cost paid on issue of treasury shares | |
12 | | |
| (45,599 | ) | |
| (215,634 | ) |
Principal element of lease payment | |
| | |
| (140,616 | ) | |
| (150,979 | ) |
Interest received | |
19 | | |
| 37,175 | | |
| 299 | |
Interest paid | |
19 | | |
| (9,748 | ) | |
| (34,746 | ) |
Net cash from/ (used in) financing activities | |
| | |
| 5,511,910 | | |
| (914,606 | ) |
| |
| | |
| | | |
| | |
Increase/(decrease) in cash and cash equivalents | |
| | |
| 389,690 | | |
| (11,589,511 | ) |
| |
| | |
| | | |
| | |
Cash and cash equivalents at the beginning of the period | |
6 | | |
| 6,957,086 | | |
| 20,484,836 | |
Exchange difference on cash and cash equivalents | |
| | |
| (177,707 | ) | |
| (82,467 | ) |
| |
| | |
| | | |
| | |
Cash and cash equivalents at the end of the period | |
6 | | |
| 7,169,069 | | |
| 8,812,858 | |
The accompanying notes form an integral part of
these consolidated financial statements.
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
Unaudited Notes to the Interim Condensed Consolidated
Financial Statements
for the three-month and six-month periods ended
June 30, 2023
(Amounts in Swiss francs)
1. General information
Addex Therapeutics Ltd (the “Company”), formerly Addex
Pharmaceuticals Ltd, and its subsidiaries (together, the “Group”) are a clinical stage pharmaceutical group applying its leading
allosteric modulator drug discovery platform to discovery and development of small molecule pharmaceutical products, with an initial focus
on central nervous system disorders.
The Company is a Swiss stockholding corporation domiciled c/o Addex
Pharma SA, Chemin des Aulx 12, CH1228 Plan-les-Ouates, Geneva, Switzerland and the parent company of Addex Pharma SA, Addex Pharmaceuticals
France SAS and Addex Pharmaceuticals Inc. Its registered shares are traded at the SIX, Swiss Exchange, under the ticker symbol ADXN. On
January 29, 2020, the Group listed on the Nasdaq Stock Market, American Depositary Shares (ADSs) under the symbol “ADXN”,
without a new issuance of securities. ADSs represents shares that continue to be admitted to trading on SIX Swiss Exchange.
These interim condensed consolidated financial statements have been
approved for issuance by the Board of Directors on August 9, 2023.
2. Basis of preparation
These interim condensed consolidated financial statements for the three-month
and six-month periods ended June 30, 2023, have been prepared under the historic cost convention and in accordance with IAS 34 “Interim
Financial Reporting” and are presented in a format consistent with the consolidated financial statements under IAS 1 “Presentation
of Financial Statements”. However, they do not include all of the notes that would be required in a complete set of financial statements.
Thus, this interim financial report should be read in conjunction with the consolidated financial statements for the year ended December 31,
2022.
Interim financial results are not necessarily indicative of results
anticipated for the full year. The preparation of these unaudited interim condensed consolidated financial statements made in accordance
with IAS 34 requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the
reporting period. Although these estimates are based on management’s best knowledge of current events and actions, actual results
ultimately may differ from those estimates. The areas involving a higher degree of judgment which are significant to the interim condensed
consolidated financial statements are disclosed in note 4 to the consolidated financial statements for the year ended December 31,
2022.
A number of new or amended standards and interpretations became applicable
for financial reporting periods beginning on or after January 1, 2023. The Group noted that the latter did not have a material impact
on the Group’s financial position or disclosures made in the interim condensed consolidated financial statements.
Due to rounding, numbers presented throughout these interim condensed
consolidated financial statements may not add up precisely to the totals provided. All ratios and variances are calculated using the underlying
amounts rather than the presented rounded amounts.
Where necessary, comparative figures have been revised to conform with
the current year 2023 presentation.
3. Critical accounting estimates and judgments
The Group makes estimates and assumptions concerning the future. These
estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of
future events that are believed to be reasonable under the circumstances. The resulting accounting estimates will, by definition, seldom
equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying
amounts of assets and liabilities or may have had a significant impact on the reported results are disclosed below:
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
Going concern
The Group’s accounts are prepared on a going concern basis. To
date, the Group has financed its cash requirements primarily from share issuances and licensing certain of its research and development
stage products. The Group is a development-stage enterprise and is exposed to all the risks inherent in establishing a business. The Group
expects that its existing cash and cash equivalents, at the issuance date of these unaudited interim condensed consolidated financial
statements, will not be sufficient to fund its operations and meet all of its obligations as they fall due for a period of 12 months.
These factors individually and collectively indicate that a material uncertainty exists that raise substantial doubt about the Group's
ability to continue as a going concern for one year from the date of issuance of these unaudited interim condensed consolidated financial
statements. The future viability of the Group is dependent on its ability to raise additional capital through public or private financings
or collaboration agreements to finance its future operations, which may be delayed due to reasons outside of the Group’s control.
The sale of additional equity may dilute existing shareholders. The inability to obtain funding, as and when needed, would have a negative
impact on the Group’s financial condition and ability to pursue its business strategies. If the Group is unable to obtain the required
funding to run its operations and to develop and commercialize its product candidates, the Group could be forced to delay, reduce or stop
some or all of its research and development programs to ensure it remains solvent. Management continues to explore options to obtain additional
funding, including through collaborations with third parties related to the future potential development and/or commercialization of its
product candidates. However, there is no assurance that the Group will be successful in raising funds, entering collaboration agreements,
obtaining sufficient funding on terms acceptable to the Group, or if at all, which could have a material adverse effect on the Group’s
business, results of operations and financial condition.
COVID-19
In early 2020 a coronavirus disease (COVID-19) pandemic developed globally
resulting in a significant number of infections and negative effects on economic activity. The Group is actively monitoring the situation
and is taking any necessary measures to respond to the situation in cooperation with the various stakeholders. On June 17, 2022 the
Group terminated its dipraglurant US registration program including pivotal Phase 2B/3 and open label clinical trials of dipraglurant
in levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID) due to a slow recruitment of patients, attributed to
the consequences of COVID-19 related patient concerns about participation in clinical studies, as well as staffing shortages and turnover
within study sites. Depending on the duration of the COVID-19 crisis and continued negative impact on global economic activity, the Group
may have to take additional measures that will have a negative impact on the Group’s business continuity and may experience certain
liquidity restraints as well as incur impairments on its assets. The exact impact on the Group’s activities in 2023 and thereafter
cannot be reasonably predicted.
Russia’s invasion of Ukraine
On February 24, 2022, Russia invaded Ukraine. The resulting conflict
and retaliatory measures by the global community have created global security concerns, including the possibility of expanded regional
or global conflict, which have had, and are likely to continue to have, short-term and more likely longer-term adverse impacts on Ukraine
and Europe and around the globe. Potential ramifications include disruption of the supply chain including research and development activities
being conducted by the Group and its strategic partners. The Group and partners rely on global networks of contract research organizations
to engage clinical study sites and enroll patients, certain of which are in Russia and Ukraine. Delays in research and development activities
of the Group and its partners could increase associated costs and, depending upon the duration of any delays, require the Group and its
partners to find alternative suppliers at additional expense. In addition, the conflict in Eastern Europe has had significant ramifications
on global financial markets, which may adversely impact the ability of the Group to raise capital on favorable terms or at all.
Revenue recognition
Revenue is primarily from fees related to licenses, milestones and
research services. Given the complexity of the relevant agreements, judgements are required to identify distinct performance obligations,
allocate the transaction price to these performance obligations and determine when the performance obligations are met. In particular,
the Group’s judgement over the estimated stand-alone selling price which is used to allocate the transaction price to the performance
obligations is disclosed in note 15.
Grants
Grants are recorded at their fair value when there is reasonable assurance
that they will be received and recognized as income when the Group has satisfied the underlying grant conditions. In certain circumstances,
grant income may be recognized before explicit grantor acknowledgement that the conditions have been met.
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
Accrued research and development costs
The Group records accrued expenses for estimated costs of research
and development activities conducted by third party service providers based upon the estimated amount of services provided but not yet
invoiced, and these costs are included in accrued expenses on the balance sheets and within research and development expenses in the statements
of comprehensive loss. These costs are a significant component of research and development expenses and due to the nature of estimates,
the Group may be required to make changes to the estimates as it becomes aware of additional information about the status or conduct of
its research activities.
Research and development costs
The Group recognizes expenditure incurred in carrying out its research
and development activities, including development supplies, until it becomes probable that future economic benefits will flow to the Group,
which results in recognizing such costs as intangible assets, involving a certain degree of judgement. Currently, such development supplies
are associated with pre-clinical and clinical trials of specific products that have not demonstrated technical feasibility.
Share-based compensation
The Group recognizes an expense for share-based compensation based
on the valuation of equity incentive units using the Black-Scholes valuation model. A number of assumptions related to the volatility
of the underlying shares and to the risk-free rate are made in this model. Should the assumptions and estimates underlying the fair value
of these instruments vary significantly from management’s estimates, then the share-based compensation expense would be materially
different from the amounts recognized.
Pension obligations
The present value of the pension obligations is calculated by an independent
actuary and depends on a number of assumptions that are determined on an actuarial basis such as discount rates, future salary and pension
increases, and mortality rates. Any changes in these assumptions will impact the carrying amount of pension obligations. The Group determines
the appropriate discount rate at the end of each period. This is the interest rate that should be used to determine the present value
of estimated future cash outflows expected to be required to settle the pension obligations. In determining the appropriate discount rate,
the Group considers the interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will
be paid, and that have terms to maturity approximating the terms of the related pension liability. Other key assumptions for pension obligations
are based in part on current market conditions.
4. Interim measurement note
Seasonality
of the business: The business is not subject to any seasonality, but expenses and corresponding revenue are largely determined
by the phase of the respective projects, particularly with regard to external research and development expenditures.
Costs:
Costs that incur unevenly during the financial year are anticipated or deferred in the interim report only if it would also be appropriate
to anticipate or defer such costs at the end of the financial year.
5. Segment reporting
Management has identified one single operating segment, related to
the discovery, development and commercialization of small-molecule pharmaceutical products.
Information about products, services and major customers
External income of the Group for the three-month and six-month periods
ended June 30, 2023 and 2022 is derived from the business of discovery, development and commercialization of pharmaceutical products.
Income was earned from rendering of research services to a pharmaceutical company.
Information about geographical areas
External income is exclusively recorded in the
Swiss operating company.
Analysis of revenue from contract with customer and other income by
nature is detailed as follows:
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Collaborative research funding | |
| 630,877 | | |
| 183,354 | | |
| 1,131,769 | | |
| 420,591 | |
Other service income | |
| 1,100 | | |
| 3,089 | | |
| 2,255 | | |
| 9,800 | |
Total | |
| 631,977 | | |
| 186,443 | | |
| 1,134,024 | | |
| 430,391 | |
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
Analysis of revenue from contract with customer and other income by
major counterparties is detailed as follows:
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Indivior PLC | |
| 630,877 | | |
| 183,354 | | |
| 1,131,769 | | |
| 420,591 | |
Other counterparties | |
| 1,100 | | |
| 3,089 | | |
| 2,255 | | |
| 9,800 | |
Total | |
| 631,977 | | |
| 186,443 | | |
| 1,134,024 | | |
| 430,391 | |
For more detail, refer to note 15, “Revenue from contract with
customer” and note 16 “Other income”.
The geographical allocation of long-lived assets is detailed as follows:
| |
June 30, 2023 | | |
December 31, 2022 | |
Switzerland | |
| 306,505 | | |
| 452,732 | |
France | |
| 352 | | |
| 357 | |
Total | |
| 306,857 | | |
| 453,089 | |
The geographical analysis of operating costs is as follows:
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Switzerland | |
| 3,189,652 | | |
| 7,267,558 | | |
| 6,072,960 | | |
| 13,264,551 | |
United States of America | |
| (11,863 | ) | |
| 10,740 | | |
| 5,274 | | |
| 18,448 | |
France | |
| 964 | | |
| 360 | | |
| 2,071 | | |
| 2,192 | |
Total operating costs (note 17) | |
| 3,178,753 | | |
| 7,278,658 | | |
| 6,080,305 | | |
| 13,285,191 | |
The capital expenditure during the six-month period ended June 30,
2023 is CHF 4,959 (nil for the six-month period ended June 30, 2022).
6. Cash and cash equivalents
| |
June 30, 2023 | | |
December 31, 2022 | |
Cash at bank and on hand | |
| 7,169,069 | | |
| 6,957,086 | |
Total cash and cash equivalents | |
| 7,169,069 | | |
| 6,957,086 | |
Split by currency:
| |
June 30, 2023 | | |
December 31, 2022 | |
CHF | |
| 20.75 | % | |
| 52.98 | % |
USD | |
| 71.82 | % | |
| 42.10 | % |
EUR | |
| 4.84 | % | |
| 2.69 | % |
GBP | |
| 2.59 | % | |
| 2.23 | % |
Total | |
| 100.00 | % | |
| 100.00 | % |
The Group no longer pays interest on CHF cash and cash equivalents
from the third quarter of 2022 whilst it earns interests on USD cash and cash equivalents. The Group invests its cash balances into a
variety of current and deposit accounts mainly with one Swiss bank whose external credit rating is P-1/A-1.
All cash and cash equivalents were held either at banks or on hand
as of June 30, 2023 and December 31, 2022.
7. Other current assets
| |
June 30, 2023 | | |
December 31, 2022 | |
Other financial assets | |
| 16,744 | | |
| 3,165 | |
Trade and other receivables | |
| 255,656 | | |
| 416,875 | |
Contract asset (Indivior PLC) | |
| 246,626 | | |
| 181,441 | |
Prepayments | |
| 1,003,491 | | |
| 270,394 | |
Total other current assets | |
| 1,522,517 | | |
| 871,875 | |
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
Other current assets increased by CHF 0.7 million as of June 30,
2023 compared to December 31, 2022 primarily due to increased prepayments in Directors and Officers (D&O) Insurance premium and
retirement benefits paid annually at the beginning of the year. The Group applies the IFRS 9 simplified approach to measuring expected
credit losses (“ECL”), which uses a lifetime expected loss allowance for all contract assets, trade receivables and other
receivables. As of June 30, 2023, the combined amount of the contract asset, trade receivables and other receivables primarily relating
to the research agreement with Indivior, amounted to CHF 0.5 million compared to CHF 0.6 million as of December 31, 2022 and decreased
by CHF 0.1 million primarily due to the payment of the grant by Eurostars/Innosuisse in Q1 2023. The Group considers contract asset, trade
receivables and other receivables have a low risk of default based on historic loss rates and forward-looking information on macroeconomic
factors affecting the ability of the third parties to settle invoices. As a result, expected loss allowance has been deemed as nil as
of June 30, 2023 and December 31, 2022.
8. Right-of-use assets
Year ended December 31, 2022 | |
Properties | | |
Equipment | | |
Total | |
Opening net book amount | |
| 456,885 | | |
| 13,104 | | |
| 469,989 | |
Depreciation charge | |
| (277,069 | ) | |
| (14,504 | ) | |
| (291,573 | ) |
Effect of lease modifications | |
| 173,281 | | |
| 5,916 | | |
| 179,197 | |
Closing net book amount | |
| 353,097 | | |
| 4,516 | | |
| 357,613 | |
As of December 31, 2022 | |
Properties | | |
Equipment | | |
Total | |
Cost | |
| 1,471,850 | | |
| 13,542 | | |
| 1,485,392 | |
Accumulated depreciation | |
| (1,118,753 | ) | |
| (9,026 | ) | |
| (1,127,779 | ) |
Net book value | |
| 353,097 | | |
| 4,516 | | |
| 357,613 | |
Period ended June 30, 2023 | |
Properties | | |
Equipment | | |
Total | |
Opening net book amount | |
| 353,097 | | |
| 4,516 | | |
| 357,613 | |
Depreciation charge | |
| (136,906 | ) | |
| (1,354 | ) | |
| (138,260 | ) |
Closing net book amount | |
| 216,191 | | |
| 3,162 | | |
| 219,353 | |
As of June 30, 2023 | |
Properties | | |
Equipment | | |
Total | |
Cost | |
| 1,471,850 | | |
| 13,542 | | |
| 1,485,392 | |
Accumulated depreciation | |
| (1,255,659 | ) | |
| (10,380 | ) | |
| (1,266,039 | ) |
Net book value | |
| 216,191 | | |
| 3,162 | | |
| 219,353 | |
9. Property, plant and equipment
Year ended December 31, 2022 | |
Equipment | | |
Furniture &
fixtures | | |
Chemical library | | |
Total | |
Opening net book amount | |
| 72,111 | | |
| - | | |
| - | | |
| 72,111 | |
Additions | |
| 581 | | |
| - | | |
| - | | |
| 581 | |
Depreciation charge | |
| (31,571 | ) | |
| - | | |
| - | | |
| (31,571 | ) |
Closing net book amount | |
| 41,121 | | |
| - | | |
| - | | |
| 41,121 | |
As of December 31, 2022 | |
Equipment | | |
Furniture &
fixtures | | |
Chemical library | | |
Total | |
Cost | |
| 1,714,409 | | |
| 7,564 | | |
| 1,207,165 | | |
| 2,929,138 | |
Accumulated depreciation | |
| (1,673,288 | ) | |
| (7,564 | ) | |
| (1,207,165 | ) | |
| (2,888,017 | ) |
Net book value | |
| 41,121 | | |
| - | | |
| - | | |
| 41,121 | |
Period ended June 30, 2023 | |
Equipment | | |
Furniture &
fixtures | | |
Chemical library | | |
Total | |
Opening net book amount | |
| 41,121 | | |
| - | | |
| - | | |
| 41,121 | |
Additions | |
| 4,959 | | |
| - | | |
| - | | |
| 4,959 | |
Depreciation charge | |
| (12,926 | ) | |
| - | | |
| - | | |
| (12,926 | ) |
Closing net book amount | |
| 33,154 | | |
| - | | |
| - | | |
| 33,154 | |
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
As of June 30, 2023 | |
Equipment | | |
Furniture &
fixtures | | |
Chemical library | | |
Total | |
Cost | |
| 1,719,368 | | |
| 7,564 | | |
| 1,207,165 | | |
| 2,934,097 | |
Accumulated depreciation | |
| (1,686,214 | ) | |
| (7,564 | ) | |
| (1,207,165 | ) | |
| (2,900,943 | ) |
Net book value | |
| 33,154 | | |
| - | | |
| - | | |
| 33,154 | |
10. Non-current financial assets
| |
June 30, 2023 | | |
December 31, 2022 | |
Security rental deposits | |
| 54,350 | | |
| 54,355 | |
Total non-current financial assets | |
| 54,350 | | |
| 54,355 | |
11. Payables and accruals
| |
June 30, 2023 | | |
December 31, 2022 | |
Trade payables | |
| 1,114,486 | | |
| 1,276,546 | |
Social security and other taxes | |
| 186,354 | | |
| 120,875 | |
Accrued expenses | |
| 1,213,118 | | |
| 1,598,583 | |
Total payables and accruals | |
| 2,513,958 | | |
| 2,996,004 | |
All payables mature within 3 months. Accrued expenses and trade
payables primarily relate to R&D services from contract research organizations, consultants and professional fees. The total amount
of payables and accruals decreased by CHF 0.5 million as of June 30, 2023 compared to December 31, 2022 mainly due to our dipraglurant
clinical development activities. The carrying amounts of payables do not materially differ from their fair values, due to their short-term
nature.
12. Share capital
| |
Number of shares | |
| |
Common shares | | |
Treasury shares | | |
Total | |
Balance as of January 1, 2022 | |
| 49,272,952 | | |
| (11,374,803 | ) | |
| 37,898,149 | |
Issue of shares – treasury shares | |
| 16,000,000 | | |
| (16,000,000 | ) | |
| - | |
Net purchase of shares under liquidity agreement | |
| - | | |
| (21,949 | ) | |
| (21,949 | ) |
Balance as of June 30, 2022 | |
| 65,272,952 | | |
| (27,396,752 | ) | |
| 37,876,200 | |
| |
Number of shares | |
| |
Common shares | | |
Treasury shares | | |
Total | |
Balance as of January 1, 2023 | |
| 115,348,311 | | |
| (38,214,291 | ) | |
| 77,134,020 | |
Issue of shares – treasury shares | |
| 17,600,000 | | |
| (17,600,000 | ) | |
| . | |
Sale of shares under shelf registration | |
| - | | |
| 7,999,998 | | |
| 7,999,998 | |
Exercise
of pre-funded warrants (1) | |
| 3,502,950 | | |
| - | | |
| 3,502,950 | |
Sale of shares under sale agency agreement | |
| - | | |
| 3,742,506 | | |
| 3,742,506 | |
Net purchase of shares under liquidity agreement | |
| - | | |
| (27,145 | ) | |
| (27,145 | ) |
Acquisition of shares forfeited from DSPPP | |
| - | | |
| (7,311 | ) | |
| (7,311 | ) |
Balance as of June 30, 2023 | |
| 136,451,261 | | |
| (44,106,243 | ) | |
| 92,345,018 | |
Shares reclassed as treasury shares under IFRS 2 | |
| - | | |
| (17,431,572 | ) | |
| (17,431,572 | ) |
Balance as of June 30, 2023 IFRS 2 | |
| 136,451,261 | | |
| (61,537,815 | ) | |
| 74,913,446 | |
| (1) | In accordance with Swiss corporate law, the issuance of 3,502,950 new shares through the exercise of pre-funded
warrants during the first half of 2023 will be registered in the trade register in early 2024 at the latest in accordance with Swiss Corporate
law. As of June 30, 2023, the amount of the share capital as registered in the trade register is CHF 1,329,483.11 divided into 132,948,311
shares. |
As of June 30, 2023, 92,345,018 shares were outstanding excluding
44,106,243 treasury shares directly held by Addex Pharma SA and including 17,431,572 outstanding shares benefiting from our DSPPP, considered
as treasury shares under IFRS 2 (see note 13). All shares have a nominal value of CHF 0.01. As of December 31, 2022, 77,134,020 shares
were outstanding excluding 38,214,291 treasury shares directly held by Addex Pharma SA and including 17,438,883 outstanding shares benefiting
from our DSPPP, considered as treasury shares under IFRS 2. All shares had a nominal value of CHF 0.01 following the reduction of the
nominal value effective on July 26, 2022.
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
The Group maintains a liquidity agreement with Kepler Cheuvreux (“Kepler”).
Under the agreement, the Group has provided Kepler with cash and shares to enable them to buy and sell the Company’s shares. As
of June 30, 2023, 155,345 (December 31, 2022: 128,200) treasury shares are recorded under this agreement in the treasury share
reserve and CHF 2,466 (December 31, 2022: CHF 3,165) is recorded in other financial assets.
During the six-month period ended June 30, 2023, the Group sold
3,742,506 treasury shares under the sale agency agreement with Kepler Cheuvreux at an average price of CHF 0.31 per share with a gross
proceed of CHF 1,176,781.
On
June 14, 2023 the Company issued 17,600,000 new shares from its capital band to its 100% owned subsidiary, Addex Pharma SA, at CHF 0.01.
These shares are held as treasury shares, hence the operation does not impact the outstanding share capital.
On April 3, 2023, the Group entered into
a securities purchase agreement with one institutional investor. The Group sold 7,999,998 treasury shares in the form of 1,333,333 ADSs
at a price of USD 0.95 per ADS (CHF 0.14 per share) and 23,578,950 pre-funded warrants, in the form of 3,929,825 ADSs at a price of USD
0.94 per ADS (CHF 0.14 per share) with a remaining strike price of USD 0.01 per ADS. During the second quarter of 2023, the institutional
investor exercised 3,502,950 pre-funded warrants in a form of 583,825 ADSs allowed by the issuance of 3,502,950 new shares through our
listed conditional capital. The new issued shares will be registered in the trade register in early 2024 in accordance with Swiss corporate
law. As of June 30, 2023, 20,076,000 pre-funded warrants in a form of 3,346,000 ADSs were remaining to be exercised. The total gross
proceeds from the offering amounted to USD 5.0 million (CHF 4.5 million) and directly attributable share offering costs of CHF 0.2 million
were recorded as a deduction in equity. In addition, the Group granted the institutional investor, 31,578,948 warrants, in the form of
5,263,158 ADSs, with a strike price of USD 1.00 per ADS (CHF 0.15 per share) and an exercise period expiring on April 5, 2028. The
fair value of the warrants amounts to CHF 1.78 million and has been recorded in equity as cost of the offering. The Group also reduced
the strike price to USD 1.00 per ADS and extended the exercise period to April 5, 2028 of 9,230,772 warrants in the form of 1,538,462
ADSs issued on December 21, 2021 and 15,000,000 warrants in the form of 2,500,000 ADSs issued on July 26, 2022. These amendments
to the exercise conditions resulted in an increase in the total fair value of CHF 0.96 million that has been recorded in equity as a cost
of the offering.
On
February 2, 2022, the Company issued 16,000,000 new shares from the authorized capital to its 100% owned subsidiary, Addex Pharma
SA, at CHF 1.00. These shares are held as treasury shares, hence the operation does not impact the outstanding share capital.
Directly attributable share issuance costs of CHF 0.2 million were recorded as a deduction in equity.
13. Share-based compensation
The total share-based compensation expense recognized in the statement
of comprehensive loss for equity incentive units granted to directors, executives, employees and consultants for the three-month and six-month
periods ended June 30, 2023 amounted to CHF 490,601 and CHF 921,797, respectively (CHF 659,259 and CHF 2,099,311 for the three-month
and six-month periods ended June 30, 2022). The decrease of CHF 0.2 million and CHF 1.2 million for the three-month and six-month
periods is primarily related to the increase in fair value of equity incentive units during the first quarter of 2022 following the modification
of certain terms on January 4, 2022.
As of June 30, 2023, 13,949,886 options were
outstanding (respectively 777,000 options as of December 31, 2022). During the six-month period ended June 30, 2023, the Group
granted 13,172,886 options with vesting over 4 years and a 10-year exercise period of which 12,736,209 options exercisable at CHF 0.13
and 436,677 options exercisable at CHF 0.10. As of June 30, 2023 and December 31, 2022, there are no equity sharing certificates
(ESCs) outstanding.
As of June 30, 2023, 17,431,572 shares benefiting
from our Deferred Strike Price Payment Plan (DSPPP) were outstanding (respectively 17,438,883 shares as of December 31, 2022). During
the first half of 2023, 7,311 shares have been forfeited from our DSPPP. All the shares benefiting from our DSPPP have been recorded as
treasury shares in accordance with IFRS 2 (see note 12).
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
14. Retirement benefits obligations
The amounts recognized in the statement of comprehensive
loss are as follows:
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Current service cost | |
| (67,188 | ) | |
| (85,432 | ) | |
| (133,722 | ) | |
| (170,864 | ) |
Past service cost | |
| - | | |
| 36,459 | | |
| 26,899 | | |
| 36,459 | |
Interest cost | |
| (46,888 | ) | |
| (9,705 | ) | |
| (93,778 | ) | |
| (19,410 | ) |
Interest income | |
| 45,240 | | |
| 6,996 | | |
| 90,480 | | |
| 13,992 | |
Company pension amount (note 18) | |
| (68,836 | ) | |
| (51,682 | ) | |
| (110,121 | ) | |
| (139,823 | ) |
Swiss Life communicated a decrease in conversion rate in the first
quarter of 2023 and in the second quarter of 2022, which led to a positive past service cost for the six-month periods ended June 30,
2023 and June 30, 2022.
The amounts recognized in the balance sheet are determined as follows:
| |
June 30, 2023 | | |
December 31, 2022 | |
Defined benefit obligation | |
| (8,495,027 | ) | |
| (7,682,529 | ) |
Fair value of plan assets | |
| 8,369,164 | | |
| 7,867,835 | |
Effect of asset ceiling | |
| - | | |
| (185,306 | ) |
Funded status shortfall | |
| (125,863 | ) | |
| - | |
As of June 30, 2023, the funded status has a shortfall of CHF
0.1 million compared to a surplus of CHF 0.2 million as of December 31, 2022 not recorded as an asset in accordance with the asset
ceiling rules and minimum funding requirements. This decrease in funded status is primarily due to the discount rate that decreased
from 2.30% as of December 31, 2022 to 1.85% as of June 30, 2023.
15. Revenue from contract with customer
License & research agreement with Indivior PLC
On January 2, 2018, the Group entered into an agreement with Indivior
for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases.
This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program at the
Group to discover novel GABAB PAM compounds.
The contract contains two distinct material promises and performance
obligations: (1) the selected compound ADX71441 which falls within the definition of a licensed compound, whose rights of use and
benefits thereon was transferred in January 2018 and, (2) the research services to be conducted by the Group and funded by Indivior
to discover novel GABAB PAM compounds for clinical development that may be discovered over the research term of the agreement and selected
by Indivior.
Indivior has sole responsibility, including funding liability, for
development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and
commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement.
Through the Group’s participation in a joint development committee, the Group reviews, in an advisory capacity, any development
programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.
Under terms of the agreement, the Group granted Indivior an exclusive
license to use relevant patents and know-how in relation to the development and commercialization of product candidates selected by Indivior.
Subject to agreed conditions, the Group and Indivior jointly own all intellectual property rights that are jointly developed and the Group
or Indivior individually own all intellectual property rights that the Group or Indivior develop individually. The Group has retained
the right to select compounds from the research program for further development in areas outside the interest of Indivior including Charcot-Marie-Tooth
type 1A neuropathy, or CMT1A, chronic cough and pain. Under certain conditions, but subject to certain consequences, Indivior may
terminate the agreement.
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
In January 2018, the Group received, under the terms of the agreement,
a non-refundable upfront fee of USD 5.0 million for the right to use the clinical candidate, ADX71441, including all materials and know-how
related to this clinical candidate. In addition, the Group is eligible for payments on successful achievement of pre-specified clinical,
regulatory and commercial milestones totaling USD 330 million and royalties on net sales of mid-single digits to low double-digits.
On February 14, 2019, Indivior terminated the development
of their selected compound, ADX71441. Separately, Indivior funds research at the Group, based on a research plan to be mutually agreed
between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed
compounds. The Group agreed with Indivior to an initial research term of two years, which can be extended by twelve month increments and
a minimum annual funding of USD 2 million for the Group’s R&D costs incurred. R&D costs are calculated based on the costs
incurred in accordance with the contract. Following Indivior’s selection of one newly identified compound, the Group has the right
to also select one additional newly identified compound. The Group is responsible for the funding of all development and commercialization
costs of its selected compounds and Indivior has no rights to the Group’s selected compounds. The initial two-year research term
was expected to run from May 2018 to April 2020. In 2019, Indivior agreed to an additional research funding of USD 1.6
million, for the research period. On October 30, 2020, the research term was extended until June 30, 2021 and Indivior agreed
to additional research funding of USD 2.8 million. Effective May 1, 2021, the research term was extended until July 31, 2022
and Indivior agreed additional research funding of CHF 3.7 million, of which CHF 2.7 million has been paid to the Group and CHF 1.0 million
paid directly by Indivior to third party suppliers that are supporting the funded research program. In August 2022, the research
agreement was extended until March 31, 2023 and Indivior agreed to additional research funding of CHF 0.85 million. The reserved
indications, where Addex retains exclusive rights to develop its own independent GABAB PAM program, have also been expanded to include
chronic cough. Effective November 1, 2022, the research term was extended until June 30, 2023 and Indivior agreed to additional
research funding of CHF 0.95 million. At the end of the first half of 2023, Indivior agreed to extend the research contract for one
year terminating on June 30, 2024 and provide additional funding.
For the three-month and six-month periods ended June 30, 2023,
the Group recognized CHF 0.6 million and CHF 1.1 million as revenue (For the three-month and the six-month periods ended June 30,
2022, CHF 0.2 million and CHF 0.4 million, respectively) and recorded a combined amount of CHF 0.4 million in contract asset and trade
receivable as of June 30, 2023 (December 31, 2022: CHF 0.4 million).
Janssen Pharmaceuticals Inc. (formerly
Ortho-McNeil-Janssen Pharmaceuticals Inc)
On December 31, 2004, the Group entered into a research collaboration
and license agreement with Janssen Pharmaceuticals Inc. (JPI). In accordance with this agreement, JPI has acquired an exclusive worldwide
license to develop mGlu2 PAM compounds for the treatment of human health. The Group is eligible to receive up to EUR 109 million in success-based
development and regulatory milestone, and low double-digit royalties on net sales. The Group considers these various milestones to be
variable considerations as they are contingent upon achieving uncertain, future development stages and net sales. For this reason, the
Group considers the achievement of the various milestones as binary events that will be recognized as revenue upon occurrence.
No amounts have been recognized under this agreement in the three-month
and six-month periods ended June 30, 2023 and 2022.
16. Other income
Under a grant agreement with Eurostars/Innosuisse the Group is required
to complete specific research activities within a defined period of time. The Group’s funding is fixed and received based on the
satisfactory completion of the agreed research activities and incurring the related costs. The Group was awarded a grant by Eurostars/Innosuisse
in 2019 for CHF 0.5 million of which CHF 0.38 million and CHF 0.12 million were received in October 2019 and February 2023,
respectively. As a consequence, receivables related to Eurostars/Innosuisse were nil as of June 30, 2023 (CHF 0.12 million as of
December 31, 2022).
The Group additionally recognized other income from IT consultancy
agreements.
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
17. Operating costs
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Staff costs (note 18) | |
| 1,411,960 | | |
| 1,352,084 | | |
| 2,755,388 | | |
| 3,545,057 | |
Depreciation (notes 8/9) | |
| 75,407 | | |
| 83,346 | | |
| 151,186 | | |
| 170,178 | |
External research and development costs | |
| 751,860 | | |
| 4,677,306 | | |
| 1,460,642 | | |
| 7,184,492 | |
Laboratory consumables | |
| 109,151 | | |
| 100,849 | | |
| 178,773 | | |
| 182,211 | |
Patent maintenance and registration costs | |
| 56,349 | | |
| 96,617 | | |
| 118,691 | | |
| 171,849 | |
Professional fees | |
| 368,927 | | |
| 323,390 | | |
| 662,455 | | |
| 781,544 | |
Short-term leases | |
| 10,279 | | |
| 14,596 | | |
| 18,495 | | |
| 27,861 | |
D&O Insurance | |
| 158,597 | | |
| 411,861 | | |
| 314,912 | | |
| 795,688 | |
Other operating costs | |
| 236,223 | | |
| 218,609 | | |
| 419,763 | | |
| 426,311 | |
Total operating costs | |
| 3,178,753 | | |
| 7,278,658 | | |
| 6,080,305 | | |
| 13,285,191 | |
The evolution of the total operating costs is mainly driven by staff
costs, external research and development costs, professional fees, D&O insurance and other operating costs.
During the six-month period ended June 30, 2023, total operating
costs decreased by CHF 7.2 million compared to the same period ended June 30, 2022, primarily due to decreased dipraglurant related
external research and development activities for CHF 5.7 million. During the same period, staff costs decreased by CHF 0.8 million due
to reduced share-based services (note 18) and D&O insurance decreased by CHF 0.5 million.
During the three-month period ended June 30, 2023, total operating
costs decreased by CHF 4.1 million compared to the same period ended June 30, 2022, including CHF 3.8 million for decreased external
research and development costs related to our dipraglurant development activities and CHF 0.3 million for decreased D&O insurance.
18. Staff costs
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Wages and salaries | |
| 831,457 | | |
| 670,202 | | |
| 1,669,690 | | |
| 1,513,118 | |
Social charges and insurances | |
| 94,720 | | |
| 79,979 | | |
| 194,733 | | |
| 179,446 | |
Value of share-based services | |
| 416,947 | | |
| 550,221 | | |
| 780,844 | | |
| 1,712,670 | |
Retirement benefit (note 14) | |
| 68,836 | | |
| 51,682 | | |
| 110,121 | | |
| 139,823 | |
Total staff costs | |
| 1,411,960 | | |
| 1,352,084 | | |
| 2,755,388 | | |
| 3,545,057 | |
During the six-month period ended June 30,
2023, total staff costs decreased by CHF 0.8 million compared to the same period ended June 30, 2022, primarily due to lower share-based
service costs.
19. Finance result, net
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Interest income | |
| 13,349 | | |
| 204 | | |
| 37,175 | | |
| 299 | |
Interest cost | |
| (93 | ) | |
| (7,574 | ) | |
| (93 | ) | |
| (24,369 | ) |
Interest expense on leases | |
| (3,735 | ) | |
| (4,758 | ) | |
| (9,655 | ) | |
| (10,377 | ) |
Foreign exchange loss net | |
| (137,897 | ) | |
| (116,909 | ) | |
| (163,467 | ) | |
| (155,740 | ) |
Finance result, net | |
| (128,376 | ) | |
| (129,037 | ) | |
| (136,040 | ) | |
| (190,187 | ) |
Addex Therapeutics │unaudited
interim condensed consolidated financial statements notes
20. Loss per share
Basic and diluted loss per share is calculated by dividing the loss
attributable to equity holders of the Company by the weighted average number of shares in issue during the period excluding treasury shares.
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Loss attributable to equity holders of the Company | |
| (2,675,152 | ) | |
| (7,221,252 | ) | |
| (5,082,321 | ) | |
| (13,044,987 | ) |
Weighted average number of shares in issue | |
| 72,188,376 | | |
| 37,467,005 | | |
| 66,731,134 | | |
| 37,891,408 | |
Basic and diluted loss per share | |
| (0.04 | ) | |
| (0.19 | ) | |
| (0.08 | ) | |
| (0.34 | ) |
The Company has four categories of dilutive potential
shares: treasury shares, equity sharing certificates (“ESCs”), share options and warrants which have been ignored in the calculation
of the loss per share for the three-month and six-month periods ended June 30, 2023 and 2022, as they would be antidilutive.
21. Related party transactions
Related parties include members of the Board of Directors and the Executive
Management of the Group. The following transactions were carried out with related parties:
Key management compensation
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Salaries, other short-term employee benefits and post-employment benefits | |
| 579,815 | | |
| 482,228 | | |
| 927,505 | | |
| 922,664 | |
Consulting fees | |
| 5,375 | | |
| 77,883 | | |
| 9,725 | | |
| 123,707 | |
Share-based compensation | |
| 420,862 | | |
| 556,724 | | |
| 783,540 | | |
| 1,822,104 | |
Total | |
| 1,006,052 | | |
| 1,116,835 | | |
| 1,720,770 | | |
| 2,868,475 | |
Salaries, other short-term employee benefits and
post-employment benefits relate to members of the Board of Directors and Executive Management who are employed by the Group. Consulting
fees relate mainly to Roger Mills, a member of the Executive Management who delivers his services to the Group under a consulting contract.
The Group has a net payable to the Board of Directors and Executive Management close to nil as of June 30, 2023 (December 31,
2022: CHF 0.1 million). Share-based compensation relates to the fair value of equity incentive units recognized through profit and loss
following their vesting plan.
22. Events after the balance sheet date
On July 28, 2023, 2,946,000 shares have been
issued through the exercise of pre-funded warrants and will be registered in the trade register in early 2024 at the latest in accordance
with Swiss Corporate law. The amount of the share capital as registered in the trade register remains at CHF 1,329,483.11 divided into
132,948,311 shares.
On August 2, 2023, the research agreement
with Indivior has been extended until June 30, 2024 and Indivior committed additional research funding of CHF 2.7 million of which
CHF 1.1 million is expected to be received directly by the Group and CHF 1.6 million paid directly by Indivior to third party suppliers
that are supporting the funded research program.
Exhibit 99.2
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Overview
We are a clinical-stage pharmaceutical company
focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric
modulators. Allosteric modulators target a specific receptor or protein and alter the effect of the body’s own signaling molecules
on their target through a novel mechanism of action. These innovative small molecule drug candidates offer several potential advantages
over conventional non-allosteric molecules and may offer an improved therapeutic approach to existing drug treatments. To date, our research
and development efforts have been primarily focused on building a portfolio of proprietary drug candidates based on our allosteric modulator
development capability. We believe that the allosteric modulator principle has broad applicability across a wide range of biological
targets and therapeutic areas, but our primary focus is on G-protein coupled receptors, or GPCR, targets implicated in neurological
diseases, where we believe there is a clear medical need for new therapeutic approaches.
Using our allosteric modulator discovery capabilities,
we have developed a pipeline of proprietary clinical and preclinical stage drug candidates. We or our partners are developing these clinical
and preclinical stage proprietary drug candidates for diseases for which there are no approved therapies or where improved therapies
are needed including epilepsy, post-stroke sensorimotor recovery, substance use disorder, or, SUD, chronic cough, stress related disorders
including post-traumatic stress disorder, or PTSD, schizophrenia and other neuropsychiatric and neurodegenerative diseases.
Our lead drug candidate ADX71149, is a novel orally
active metabotropic glutamate receptor subtype 2 positive allosteric modulator, or mGlu2 PAM for the treatment of epilepsy. Our partner,
Janssen Pharmaceuticals, Inc., or Janssen, a subsidiary of Johnson & Johnson, is conducting a placebo-controlled Phase
2a proof of concept clinical trial of ADX71149 in epilepsy patients since June 2021. Cohort 1 of the study has been completed and
on May 10, 2023 we announced that an interim review committee, or IRC recommended to continue the study, following review of unblinded
data from Part 1 of patient Cohort 1. An open label study has also been underway since the third quarter of 2022 and Cohort 2 is
currently enrolling patients, testing a different dose of ADX71149. We expect to announce a further update on the status of the study
later this year. Under our agreement, Janssen is responsible for financing the development and commercialization, if any, of ADX71149.
Our second clinical stage program is dipraglurant,
a metabotropic glutamate receptor subtype 5 negative allosteric modulator, or mGlu5 NAM, for post-stroke sensorimotor recovery. Millions
of people have survived an ischemic stroke which can lead to motor paralysis, loss of sensory function, impaired autonomic functions
such as bladder/bowel control, impaired cognition leading to deficits in communication, attention and memory, and overall accompanied
by pain. There are currently no drugs to support sensorimotor recovery and current therapies rely on retraining and physiotherapy, with
rehabilitation, largely partial, taking 6 month or more. Functional recovery by stimulating network connectivity in the brain has been
demonstrated post-stroke preclinically with dipraglurant which significantly restored functional control after just three days of once-daily
treatment. We are conducting additional in vivo studies with dipraglurant in animal models of stroke and subject to funding, we plan
to commence a Phase 2a study in 2024.There is a large unmet need in post-stroke sensorimotor recovery, and we believe this innovative
approach represents a significant commercial opportunity.
We are conducting a funded research program to
discover novel gamma-aminobutyric acid subtype-b positive allosteric modulators, or GABAB PAMs for Indivior PLC, or Indivior. We are
currently in the clinical candidate selection phase and expect IND enabling studies to begin in 2024. Under the terms of the agreement
with Indivior, we have the right to select drug candidates for development in certain exclusive indications outside SUD and plan to develop
our GABAB PAM drug candidate for the treatment of chronic cough. This target is clinically validated with baclofen, an orthosteric agonist
of GABAB, is used off label to treat chronic cough patients. However, baclofen’s use is limited by serious side-effects, short
half-life and gradual loss of efficacy during chronic treatment. By more precisely targeting the GABAB receptor with a PAM we aim to
have a best-in-class treatment with improved tolerability suitable for the chronic nature of this disease. This indication has a significant
unmet medical need and represents a solid commercial opportunity. We are in late clinical candidate selection phase and have demonstrated
proof-of-concept in animal models of cough with several compounds. Subject to funding, we expect IND enabling studies to begin in 2024.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Allosteric modulators have broad applicability
for many clinically validated GPCR targets which are implicated in multiple therapeutic indications. We intend to continue to leverage
our scientific expertise in allosteric modulation and our proprietary technology platform to discover novel drug candidates for the treatment
of neurological diseases. Three of the most advanced programs include:
·
mGlu7 NAM for stress related disorders including PTSD. We are developing mGlu7 NAM as a novel orally available treatment to reduce
fear memory in PTSD, a disorder that can lead to intense fear and anxiety. Current medication is unspecific and ineffective, with a number
of side effects. By selectively targeting mGlu7 with NAMs, the brain circuitries involved in fear and anxiety can be more precisely modulated,
potentially resulting in a more focused response and fewer side effects than current therapeutic approaches. Subject to regulatory approval,
we believe our mGlu7 NAM may offer an innovative and differentiated treatment approach from existing therapies. We have selected our
clinical candidate, identified numerous back-up compounds and we are ready to initiate IND enabling studies.
·
Muscarinic acetylcholine receptor 4 positive allosteric modulator, or M4 PAM for the treatment of schizophrenia and other psychosis.
This target is clinically validated by xanomeline, a nonselective M1/M4 agonist which cannot be used widely due to side-effects. We are
currently optimizing multiple chemical series of highly selective M4 PAM compounds with the objective to improve efficacy and tolerability.
We have entered clinical candidate selection phase and expect to commence IND enabling studies in the second half of 2024.
·
mGlu2 NAM for the treatment of mild neurocognitive disorders, or mNCD. We are developing mGlu2 NAM as a novel orally available
treatment for mNCD associated with neurodegenerative disorder such as Alzheimer's disease and Parkinson's disease and depression as a
comorbidity. The program is in late lead optimization phase and we expect to enter clinical candidate selection in the second half of
2024.
We
were founded in May 2002 and completed our initial public offering of shares on the SIX Swiss Exchange in May 2007. On January 29,
2020, we listed American Depositary Shares (ADSs) representing our shares on the Nasdaq Stock Market following the United States
Securities and Exchange Commission (SEC) having declared our registration statements on Forms F-1 and F-6 effective. Our operations to
date have included organizing and staffing our company, raising capital, out-licensing rights to our research stage programs including
our mGlu2 PAM and GABAB PAM programs and conducting preclinical studies and clinical trials.
As of end of June 30, 2023, we have generated
CHF 65.9 million of revenue from the sale of license rights and conducting funded research activities for certain of our research programs.
We have historically financed our operations mainly through the sale of equity. Through June 30, 2023, we have raised an aggregate
of CHF 355.1 million of gross proceeds from the sale of equity.
We have never been profitable and have incurred
significant net losses in each period since our inception. Our net losses were CHF 5.1 million and CHF 13 million for the six-month periods
ended June 30, 2023 and June 30, 2022, respectively. As of June 30, 2023, we had accumulated losses of CHF 354.9 million.
We expect to continue to incur significant expenses and operating losses in the medium to long term. We anticipate that our expenses
will increase significantly in connection with our ongoing and future activities as we:
|
· |
continue to invest in the research and development of our allosteric
modulator discovery platform and pipeline; |
|
· |
hire additional research and
development, and general and administrative personnel; |
|
· |
maintain, expand and protect
our intellectual property portfolio; |
|
· |
identify and in-license or
acquire additional product candidates; and |
|
· |
incur additional costs associated
with operating as a public company in the United States. |
We will need substantial
additional funding to support our operating activities as we advance our research and drug candidates through clinical development, seek
regulatory approval and prepare for commercialization, if any, of our product candidates are approved. Adequate funding may not be available
to us on acceptable terms, or at all.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
We have no manufacturing
facilities, and all of our manufacturing activities are contracted out to third parties. Additionally, we currently utilize third-party
contractors to carry out a significant proportion of our research and development activities. Furthermore, we do not yet have a sales
organization.
License Agreement with Indivior
In January 2018, we entered into an agreement
with Indivior for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other
CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research
program at Addex to discover novel GABAB PAM compounds.
Indivior has sole responsibility, including funding
liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration
procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under
the agreement. Through our participation in a joint development committee, we review, in an advisory capacity, any development programs
designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.
Under terms of the agreement, we have granted
Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of drug candidates
selected by Indivior. Subject to agreed conditions, Addex and Indivior jointly own all intellectual property rights that are jointly
developed, and Addex or Indivior individually own all intellectual property rights that Addex or Indivior develop individually. Addex
has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior
including cough. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.
In January 2018, under terms of the agreement,
we received a non-refundable upfront fee of $5.0 million for the right to use the clinical candidate, ADX71441, including all materials
and know-how related to this clinical candidate. In addition, we are eligible for payments on successful achievement of pre-specified
clinical, regulatory and commercial milestones totaling $330 million, and royalties on net sales of mid-single digits to low double-digits.
On February 14, 2019, Indivior terminated the development of their selected compound, ADX71441.
Separately, Indivior
funds research at Addex, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. These
future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. We agreed with Indivior to an initial research
term of two years, which can be extended by twelve-month increments and a minimum annual funding of $2 million for the Addex R&D
costs incurred. Following Indivior’s selection of one newly identified compound, Addex has the right to also select one additional
newly identified compound. Addex is responsible for the funding of all development and commercialization costs of its selected compounds
and Indivior has no rights to the Addex selected compounds. The initial two-year research term was expected to run from May 2018
to April 2020. In 2019, Indivior agreed an additional research funding of $1.6 million, for the research period. On October 30,
2020, the research term was extended until June 30, 2021 and Indivior agreed an additional research funding of $2.8 million.
Effective May 1, 2021, the research term was extended until July 31, 2022 and Indivior agreed additional research funding of
CHF 3.7 million, of which CHF 2.7 million has been paid to the Group and CHF 1.0 million paid directly by Indivior to third party suppliers
that are supporting the funded research program. In August 2022, the research agreement was extended until March 31, 2023 with
additional research funding of CHF 0.85 million. The reserved indications, where Addex retains exclusive rights to develop its own independent
GABAB PAM program, have also been expanded to include chronic cough. Effective November 1, 2022 the research term was extended
until June 30, 2023 and Indivior agreed to additional research funding of CHF 0.95 million. Effective July 1, 2023, the research
term was extended until June 30, 2024 and Indivior agreed to additional research funding of CHF 2.7 million of which CHF 1.1 million
is expected to be received directly by the Group and CHF 1.6 million paid directly by Indivior to third party suppliers that are supporting
the funded research program.
The contract contains two distinct material promises
and performance obligations: (1) the selected compound ADX71441 which falls within the definition of a licensed compound, whose
rights of use and benefits thereon was transferred in January 2018 and, (2) the research services to be conducted by Addex
and funded by Indivior to discover novel GABAB PAM compounds for clinical development that may be discovered over the research term of
the agreement and selected by Indivior.
License Agreement with Janssen
Under our agreement with Janssen Pharmaceuticals Inc.
(formerly known as Ortho-McNeil-Janssen Pharmaceuticals Inc), or Janssen, we granted Janssen an exclusive license to use relevant patents
and know-how in relation to the development and commercialization of drug candidates selected by Janssen under the agreement and a non-exclusive
worldwide license to conduct research on the collaboration compounds using relevant patents and know-how. Subject to certain conditions,
we and they agreed to own, jointly, all intellectual property rights that we develop jointly and, individually, all intellectual property
rights that either party develops individually. Under certain conditions, but subject to certain consequences, Janssen may terminate
the agreement for any reason, subject to a 90-day notice period.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Janssen has sole responsibility, including funding
liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration
procedures and commercialization, if any, in the United States, Japan, the United Kingdom, Germany, France, Spain and Italy. Janssen
has the right to design development programs for selected compounds under the agreement. Through our participation in a joint development
committee, we review, in an advisory capacity, any development programs designed by Janssen. However, Janssen has authority over all
aspects of the development of selected compounds and may develop or commercialize third-party compounds.
Janssen initiated a Phase 2a
proof of concept clinical trial of ADX71149 in epilepsy patients in June 2021. We are eligible for a further EUR 109 million
in success-based development and regulatory milestones and low double-digit royalties on net sales.
Components of Results of Operations
Revenue
From the beginning of January 2017 through
June 2023, we recognized CHF 17.9 million as revenue primarily under our license agreement with Indivior. We do not have
approval to market or commercialize any of our drug candidates, we have never generated revenue from the sale of products and we do not
expect to generate any revenue from product sales for the foreseeable future. Prior to approval of a drug candidate, we will seek to
generate revenue from a combination of license fees, milestone payments in connection with collaborative or strategic relationships,
royalties resulting from the licensing of our drug candidates and payments from sponsored research and development activities as well
as grants from governmental and non-governmental organizations.
Revenue from collaborative arrangements comprises
the fair value for the sale of products and services, net of value-added tax, rebates and discounts. Revenue from the rendering of services
is recognized in the accounting period in which the services are rendered, by reference to completion of the specific transaction assessed
on the basis of the actual service provided as a proportion of the total service to be provided. Revenue from collaborative arrangements
may include the receipt of non-refundable license fees, milestone payments, and research and development payments. When we have continuing
performance obligations under the terms of the arrangements, non-refundable fees and payments are recognized as revenue by reference
to the completion of the performance obligation and the economic substance of the agreement.
Our revenue has varied, and we expect revenue
to continue to vary, substantially from year to year, depending on the structure and timing of milestone events, as well as our development
and commercialization strategies and those of our collaboration partners for our drug candidates. We, therefore, believe that historical
period to period comparisons are not meaningful and should not be relied upon as an indicator of our future revenue and performance potential.
Other Income
From the beginning of January 2017 through
June 2023, we recognized CHF 1.7 million as other income including CHF 1.2 million relating to grants from The Michael
J. Fox Foundation for Parkinson’s Research, or MJFF, to finance certain clinical activities related to dipraglurant development
in Parkinson’s disease levodopa-induced dyskinesia, or PD-LID, and TrKB PAM discovery activities and CHF 0.5 million related to
a grant from Eurostars/Innosuisse to support our mGlu7 NAM.
Grants are recognized at their fair value where
there is reasonable assurance that the grant will be received and that we will comply with all associated conditions. Grants relating
to costs are recognized as other income in the statement of comprehensive loss over the period necessary to match them with the costs
that they are intended to compensate.
Operating Expenses
Research and Development Costs
From the beginning of January 2017 through
June 2023, we incurred CHF 61.5 million in research and development costs. They consist mainly of direct research costs,
which include: costs associated with the use of contract research organizations, or CROs, and consultants hired to assist on our research
and development activities, personnel costs, share-based compensation for our employees and consultants, costs related to regulatory
affairs and intellectual property, as well as depreciation for assets used in research and development activities.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
We typically use our employee, consultant and
infrastructure resources across our research and development programs. We track by program the directly attributable costs from CROs
and consultants.
The following table provides a breakdown of our
outsourced research and development costs that are directly attributable to the specified programs for the three-month and six-month
periods ended June 30, 2023 and 2022:
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
| |
(CHF in thousands) | |
Dipraglurant PD-LID | |
| (191 | ) | |
| 3,268 | | |
| (161 | ) | |
| 4,946 | |
Dipraglurant blepharospasm | |
| - | | |
| 384 | | |
| - | | |
| 569 | |
GABAB PAM | |
| 420 | | |
| 327 | | |
| 591 | | |
| 578 | |
M4 PAM | |
| 413 | | |
| 423 | | |
| 789 | | |
| 572 | |
Other discovery programs | |
| 110 | | |
| 275 | | |
| 242 | | |
| 519 | |
Total outsourced research and development costs | |
| 752 | | |
| 4,677 | | |
| 1,461 | | |
| 7,184 | |
On June 17, 2022, we terminated our dipraglurant
US registration program including pivotal Phase 2B/3 and open label clinical trials in PD-LID due to slow recruitment of patients. Therefore,
our R&D costs decreased in the first half of 2023 compared to the first half of 2022 as we focus our resources on advancing our pre-clinical
portfolio. However, in the medium to long term we expect our research and development costs will increase for the foreseeable future
as we seek to advance the development of our programs.
At this time, we cannot reasonably estimate or
know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our drug candidates.
We are also unable to predict when, if ever, material net cash inflows will commence from sales of our drug candidates. This is due to
the numerous risks and uncertainties associated with developing such product candidates, including:
| · | uncertainty related to discovering clinical candidates; |
| · | uncertainty related to efficiently manufacturing and distributing
drug products; |
| · | competitor intellectual property restraining our freedom to operate;
and |
| · | timing of initiation, completion and outcome of further clinical
trials. |
In addition, the probability of success for any
of our drug candidates will depend on numerous factors, including competition, manufacturing capabilities and commercial viability. A
change in the outcome of any of these variables with respect to the development of any of our drug candidates would significantly change
the costs, timing and viability associated with the development of that drug candidate.
General and Administrative Costs
General and administrative costs consist primarily
of personnel costs, including salaries, benefits and share-based compensation cost for our employees as well as corporate facility costs
not otherwise included in research and development expenses, legal fees related to corporate matters, D&O insurances and fees for
accounting and financial or tax consulting services.
We expect our general and administrative costs
to remain stable for the foreseeable future.
Finance Result, Net
Finance result, net consists mainly of currency
exchange differences, interest expenses relating to lease liabilities, and to the negative interest rate on Swiss franc cash deposits,
partially offset by positive interest rate on USD bank deposits.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Analysis of Results of Operations
The following table presents our consolidated
results of operations for the three-month and six-month periods ended June 30, 2023 and 2022:
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
| |
(CHF in thousands) | |
Revenue | |
| 631 | | |
| 183 | | |
| 1,132 | | |
| 420 | |
Other income | |
| 1 | | |
| 3 | | |
| 2 | | |
| 10 | |
Research and development costs | |
| (1,875 | ) | |
| (5,747 | ) | |
| (3,579 | ) | |
| (9,512 | ) |
General and administrative costs | |
| (1,304 | ) | |
| (1,531 | ) | |
| (2,501 | ) | |
| (3,773 | ) |
Operating loss | |
| (2,547 | ) | |
| (7,092 | ) | |
| (4,946 | ) | |
| (12,855 | ) |
Finance income | |
| 13 | | |
| - | | |
| 37 | | |
| - | |
Finance expense | |
| (141 | ) | |
| (129 | ) | |
| (173 | ) | |
| (190 | ) |
Net loss | |
| (2,675 | ) | |
| (7,221 | ) | |
| (5,082 | ) | |
| (13,045 | ) |
Three Months Ended June 30, 2023 Compared to Three Months
Ended June 30, 2022
Revenue
The following table sets forth our revenue in
the three-month periods ended June 30, 2023 and 2022:
| |
For the three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Collaborative research funding | |
| 631 | | |
| 183 | |
Total | |
| 631 | | |
| 183 | |
Revenue increased by CHF 0.4 million in the three-month
period ended June 30, 2023 compared to the three-month period ended June 30, 2022 due to amounts received under our license
and research agreements with Indivior which are recognized as related costs are incurred.
Other Income
The following table sets forth our other income
in the three-month periods ended June 30, 2023 and 2022:
| |
For the three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Other service income | |
| 1 | | |
| 3 | |
Total | |
| 1 | | |
| 3 | |
Other income primarily relates to IT consulting
services.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Research and Development Expenses
The following table sets forth our research and
development expenses in the three-month periods ended June 30, 2023 and 2022:
| |
For the three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Dipraglurant PD-LID | |
| (191 | ) | |
| 3,268 | |
Dipraglurant blepharospasm | |
| - | | |
| 384 | |
GABAB PAM | |
| 420 | | |
| 327 | |
M4 PAM | |
| 413 | | |
| 423 | |
Other discovery programs | |
| 110 | | |
| 275 | |
Subtotal outsourced R&D per program | |
| 752 | | |
| 4,677 | |
Staff costs | |
| 775 | | |
| 686 | |
Depreciation and amortization | |
| 61 | | |
| 65 | |
Laboratory consumables | |
| 109 | | |
| 101 | |
Patent maintenance and registration costs | |
| 56 | | |
| 97 | |
Short-term leases | |
| 7 | | |
| 12 | |
Other operating costs | |
| 115 | | |
| 109 | |
Subtotal unallocated R&D expenses | |
| 1,123 | | |
| 1,070 | |
Total | |
| 1,875 | | |
| 5,747 | |
Research and development expenses decreased by
CHF 3.9 million in the three-month period ended June 30, 2023 compared to the three-month period ended June 30, 2022, mainly
due to decreased outsourced R&D costs for CHF 3.9 million primarily related to our dipraglurant clinical development activities terminated
on June 17, 2022. Changes in estimates of costs to terminate the dipraglurant clinical development resulted in the release of CHF
0.2 million and previously recorded accruals resulting in a credit to dipraglurant related R&D costs.
General and Administrative Costs
The following table sets forth our general and
administrative costs in the three-month periods ended June 30, 2023 and 2022:
| |
For the three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Staff costs | |
| 637 | | |
| 666 | |
Depreciation and amortization | |
| 14 | | |
| 18 | |
Professional fees | |
| 368 | | |
| 324 | |
Short-term leases | |
| 4 | | |
| 2 | |
D&O Insurance | |
| 159 | | |
| 412 | |
Other operating costs | |
| 122 | | |
| 109 | |
Total | |
| 1,304 | | |
| 1,531 | |
General and administrative costs decreased by
CHF 0.2 million in the three-month period ended June 30, 2023, compared to the three-month period ended June 30, 2022, primarily
due to decreased D&O insurance costs.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Finance Result, Net
The following table sets forth our finance result
net in the three-month periods ended June 30, 2023 and 2022:
| |
For the three months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Interest income | |
| 13 | | |
| - | |
Interest cost | |
| - | | |
| (8 | ) |
Interest expense on leases | |
| (4 | ) | |
| (5 | ) |
Foreign exchange losses, net | |
| (137 | ) | |
| (116 | ) |
Total | |
| (128 | ) | |
| (129 | ) |
Finance result, net remained stable during the
three-month period ended June 30, 2023 compared to the three-month period ended June 30, 2022 and primarily related to foreign
exchange loss on USD cash deposits.
Six Months Ended June 30, 2023 Compared to Six Months Ended
June 30, 2022
Revenue
The following table sets forth our revenue in
the six-month periods ended June 30, 2023 and 2022:
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Collaborative research funding | |
| 1,132 | | |
| 420 | |
Total | |
| 1,132 | | |
| 420 | |
Revenue increased by CHF 0.7 million in the six-month
period ended June 30, 2023 compared to the six-month period ended June 30, 2022 due to amounts received under our license and
research agreements with Indivior which are recognized as related costs are incurred.
Other Income
The following table sets forth our other income
in the six-month periods ended June 30, 2023 and 2022:
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Other service income | |
| 2 | | |
| 10 | |
Total | |
| 2 | | |
| 10 | |
Other income primarily relates to IT consulting
services.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Research and Development Expenses
The following table sets forth our research and
development expenses in the six-month periods ended June 30, 2023 and 2022:
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Dipraglurant PD-LID | |
| (161 | ) | |
| 4,946 | |
Dipraglurant blepharospasm | |
| - | | |
| 569 | |
GABAB PAM | |
| 591 | | |
| 578 | |
M4 PAM | |
| 789 | | |
| 572 | |
Other discovery programs | |
| 242 | | |
| 519 | |
Subtotal outsourced R&D per program | |
| 1,461 | | |
| 7,184 | |
Staff costs | |
| 1,522 | | |
| 1,629 | |
Depreciation and amortization | |
| 121 | | |
| 134 | |
Laboratory consumables | |
| 179 | | |
| 182 | |
Patent maintenance and registration costs | |
| 118 | | |
| 172 | |
Short-term leases | |
| 14 | | |
| 25 | |
Other operating costs | |
| 164 | | |
| 186 | |
Subtotal unallocated R&D expenses | |
| 2,118 | | |
| 2,328 | |
Total | |
| 3,579 | | |
| 9,512 | |
Research and development expenses decreased by
CHF 5.9 million in the six-month period ended June 30, 2023 compared to the six-month period ended June 30, 2022, mainly due
to decreased outsourced R&D costs for CHF 5.7 million relating to our dipraglurant clinical development activities terminated on
June 17, 2022. Changes in estimates of costs to terminate the dipraglurant clinical development resulted in the release of CHF 0.2
million and previously recorded accruals resulting in a credit to dipraglurant related R&D costs. During the same period, staff costs
decreased by CHF 0.1 million mainly due to reduced share-based services.
General and Administrative Costs
The following table sets forth our general and
administrative costs in the six-month periods ended June 30, 2023 and 2022:
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Staff costs | |
| 1,233 | | |
| 1,916 | |
Depreciation and amortization | |
| 30 | | |
| 36 | |
Professional fees | |
| 662 | | |
| 782 | |
Short-term leases | |
| 5 | | |
| 3 | |
D&O Insurance | |
| 315 | | |
| 796 | |
Other operating costs | |
| 256 | | |
| 240 | |
Total | |
| 2,501 | | |
| 3,773 | |
General and administrative costs decreased by
CHF 1.3 million in the six-month period ended June 30, 2023, compared to the six-month period ended June 30, 2022, primarily
due to decreased staff costs of CHF 0.7 million driven by reduced share-based services and decreased D&O insurance costs of CHF 0.5
million.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Finance Result, Net
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Interest income | |
| 37 | | |
| - | |
Interest cost | |
| - | | |
| (24 | ) |
Interest expense on leases | |
| (10 | ) | |
| (10 | ) |
Foreign exchange losses, net | |
| (164 | ) | |
| (156 | ) |
Total | |
| (136 | ) | |
| (190 | ) |
The finance result, net increased by CHF 0.1 million
during the six-month period ended June 30, 2023 compared to the six-month period ended June 30, 2022 primarily due to the absence
of negative interests on Swiss Franc cash deposits and the earning of positive interest on USD cash deposits during the first half of
2023.
Capital Resources
Since our inception through June 30, 2023,
we have generated CHF 65.9 million of revenue and have incurred net losses and negative cash flows from our operations. We
have funded our operations primarily through the sale of equity. From inception through June 30, 2023, we raised an aggregate of
CHF 355.1 million of gross proceeds from the sale of equity. As of June 30, 2023, we had CHF 7.2 million in
cash and cash equivalents.
Our primary uses of cash are to fund operating
expenses which consist mainly of research and development expenditures and associated general and administrative costs. Cash used to
fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the changes in our outstanding accounts
payable and accrued expenses. We currently have no ongoing material financing commitments, such as lines of credit or guarantees.
Our
expenses decreased in the first half of 2023 compared to the first half
of 2022 and we expect that expenses are not going to significantly increase in the near term as we have no ongoing clinical studies funded
by us. In the medium and long term, our expenses may increase in connection with our ongoing activities, particularly as we continue
to advance our portfolio of drug candidates, initiate further clinical trials and seek marketing approval for our drug candidates.
In addition, if we obtain marketing approval for
any of our drug candidates, we expect to incur significant commercialization expenses related to program sales, marketing, manufacturing
and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Accordingly,
we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital
when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future
commercialization efforts.
We
expect our existing cash and cash equivalents at the issuance date of these unaudited interim condensed consolidated financial statements
will enable us to fund our operating expenses and capital expenditure requirements through the first quarter of 2024. This indicates
that a material uncertainty exists that raise substantial doubt about the Group's ability to continue as a going concern for one year
from the date of issuance of these unaudited interim condensed consolidated financial statements.
Our future viability is dependent on our ability to monetize our intellectual property portfolio and /or raise additional capital though
public or private financings that may dilute existing shareholders. We have based this estimate on assumptions that may prove
to be wrong, and we could utilize our available capital resources sooner than we currently expect. Our future capital requirements will
depend on many factors, including:
| · | the scope, progress, results and costs of our ongoing and planned
preclinical studies; |
| · | the timing and amount of milestone and royalty payments we may
receive under our license agreements; |
| · | the extent to which we out-license, in-license, sell or acquire
other drug candidates and technologies; |
| · | the number and development requirements of other drug candidates
that we may pursue; |
| · | the costs, timing and outcome of regulatory review of our drug
candidates; |
| · | cost associated with finding alternative suppliers due to geopolitical
events such as the ongoing war in Ukraine and/or pandemics such as COVID-19; and |
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
| · | the costs and timing of future commercialization activities, including
drug manufacturing, marketing, sales and distribution, for any of our drug candidates for
which we receive marketing approval. |
Identifying potential drug candidates and conducting
preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we
may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our drug
candidates, if approved, may not achieve commercial success. Our revenue, if any, will be derived from sales of products that we do not
expect to be commercially available for many years, if at all.
Until such time, if ever, as we can generate substantial
product revenue, we may finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic
alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities,
your ownership interest will be diluted, and the terms of any additional securities may include liquidation or other preferences that
adversely affect your rights as a shareholder. Debt financing, if available, may involve agreements that include covenants limiting or
restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise funds through additional collaborations,
strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future
revenue streams, research programs or drug candidates or to grant licenses on terms that may not be favorable to us. If we are unable
to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our
product development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise
prefer to develop and market ourselves. The following table shows a summary of our cash flows for the periods indicated:
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Cash and cash equivalents at the beginning of the period | |
| 6,957 | | |
| 20,485 | |
Net cash flows used in operating activities | |
| (5,117 | ) | |
| (10,675 | ) |
Net cash flows used in investing activities | |
| (5 | ) | |
| - | |
Net cash flows from / (used in) financing activities | |
| 5,512 | | |
| (915 | ) |
Increase / (decrease) in cash and cash equivalents | |
| 390 | | |
| (11,590 | ) |
Effect of the exchange rates | |
| (178 | ) | |
| (82 | ) |
Cash and cash equivalents at the end of the period | |
| 7,169 | | |
| 8,813 | |
Operating Activities
Net cash flows used in operating activities consist
of the net loss adjusted for changes in working capital, and for non-cash items such as depreciation, the value of share-based services,
changes in post-employment benefits and finance costs.
During the six-month period ended June 30,
2023, operating activities used CHF 5.1 million of cash primarily due to our net loss of CHF 5.1 million. During the same period, the
increased net working capital of CHF 1.2 million has been offset by non-cash items amounting to CHF 1.2 million including share-based
services for CHF 0.9 million, depreciation and disposal of the right of use of assets for CHF 0.2 million and finance costs for CHF 0.1
million. The increase of the net working capital is mainly due to increased prepayments for CHF 0.7 million, primarily related to our
directors and officers (D&O) insurance premiums and retirement benefits paid annually at the beginning of the year, partially offset
by decreased trade payables and accruals for CHF 0.6 million mainly related to our dipraglurant clinical development activities.
During the six-month period ended June 30,
2022, operating activities used CHF 10.7 million of cash primarily due to our net loss of CHF 13.0 million adjusted for CHF 0.1 million
of finance costs partially offset by non-cash items of CHF 2.3 million primarily relating to the value of the share-based services.
Investing Activities
Net cash used in investing activities consist
primarily of investments in computer, laboratory equipment and security rental deposits related to laboratory and office space.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
During the six-month periods ended June 30,
2023 investing activities were close to nil, primarily related to investments in our laboratory equipment, whilst during the six-month
period ended June 30, 2023, net cash used in investing activities was nil.
Financing Activities
Cash flows from financing
activities consists of proceeds from the sale of equity securities, whilst cash flows used in financing activities primarily relate to
the principal element of lease payments and associated interest expenses, interest expenses on Swiss francs cash deposits and capital
increase costs.
During the six-month period
ended June 30, 2023, net cash flows from financing activities amounted to CHF 5.5 million including CHF 4.5 million (USD 5.0 million)
from the offering executed with one institutional investor on April 3, 2023 and CHF 1.2 million from the sale agency agreement managed
by Kepler Cheuvreux, partially offset by costs associated with the offering, the sale and the issuance of treasury shares whose combined
amount paid during the first half of 2023 amounted to CHF 0.1 million and CHF 0.1 million for the principal element of lease payments.
During the six-month period
ended June 30, 2022, net cash flows used in financing activities amounted to CHF 1.0 million including CHF 0.5 million for the costs
associated with the offering executed on December 16, 2021, paid in Q1 2022, CHF 0.2 million for the issuance costs of 16,000,000
new treasury shares on February 2, 2022 and CHF 0.2 million for the principal element of lease payments.
Off-Balance Sheet Arrangements
As of the date of the discussion and analysis
and during the period presented, we did not have, and we do not currently have, any off-balance sheet arrangements, as defined in the
rules and regulations of the U.S. Securities and Exchange Commission.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis
of our financial condition and results of operations is based on our interim condensed consolidated financial statements, which we have
prepared in accordance with International Accounting Standard 34 Interim Financial reporting as issued by the International Accounting
Standards Board.
Recent Accounting Pronouncements
The adoption of IFRS standards as issued by the
IASB and interpretations issued by the IFRS interpretations committee that are effective for the first time for the financial year beginning
on or after January 1, 2023 had no material impact on our financial position or disclosures made in our interim condensed consolidated
financial statements.
JOBS Act Transition Period
Subject to certain conditions, as an emerging
growth company, we may rely on certain of these exemptions under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, including
without limitation, (1) providing an auditor’s attestation report on our system of internal controls over financial reporting
pursuant to Section 404(b) of the Sarbanes-Oxley Act and (2) complying with any requirement that may be adopted by the
Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing
additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an
emerging growth company until the earlier to occur of (1) the last day of the fiscal year (a) December 31, 2025 (b) in
which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to be a “large accelerated
filer” under the rules of the U.S. Securities and Exchange Commission, which means the market value of our common shares that
is held by non-affiliates exceeds $700 million as of the prior June 30, and (2) the date on which we have issued more
than $1.0 billion in non-convertible debt during the prior three-year period.
Exhibit 99.3
Addex Reports 2023 Half Year and Second Quarter
Financial Results and Provides Corporate Update
| · | ADX71149
Phase 2 epilepsy clinical study Cohort 2 continues recruiting following the Independent Interim
Review Committee (IRC) recommendation |
| · | Indivior
GABAB PAM collaboration extended to June 2024 with CHF 2.7 million of committed research
funding |
| · | CHF
7.2M ($8.0M) of cash and cash equivalents at June 30, 2023 |
Ad Hoc Announcement Pursuant to Art.
53 LR
Geneva, Switzerland,
August 10, 2023 - Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering
allosteric modulation-based drug discovery and development, today reported its half-year and second quarter financial results for the
periods ended June 30, 2023 and provided a corporate update.
“During the first half, we were encouraged
by the progress being made in the ADX71149 Phase 2 epilepsy study being conducted by our partner, Janssen. Recruitment is continuing
into patient Cohort 2 following the IRC recommendation to continue the study after review of Cohort 1 Part 1 unblinded data. We
look forward to reporting progress later this year,” said Tim Dyer CEO of Addex. “Our GABAB PAM collaboration with Indivior
continues to advance and recently extended the research period to June 2024, providing a further CHF 2.7 million in funding. We
also continue to make solid progress across our preclinical portfolio and advance business discussions.”
Half-Year
2023 Operating Highlights:
| · | ADX71149
epilepsy Phase 2 study – Cohort 1 complete and Cohort 2 continues recruiting following
IRC recommendation to continuing after review of Cohort 1 Part 1 unblinded data |
| · | Dipraglurant
is Phase 2 ready – preclinical profiling in post-stroke recovery ongoing |
| · | GABAB
PAM Indivior strategic partnership for substance use disorders extended through to end June 2024
with CHF2.7 million of committed research funding - multiple drug candidates in clinical
candidate selection phase |
| · | GABAB
PAM for chronic cough - multiple drug candidates in clinical candidate selection |
| · | mGlu7
NAM for stress related disorders, including PTSD – ready for IND enabling studies |
| · | M4
PAM schizophrenia program - progressing through clinical candidate selection phase |
| · | CHF
5.7 million in equity financing year to date |
| · | Partnering
discussions across the portfolio ongoing |
Key Financial Data for the Second Quarter and the First Half of
2023:
CHF’
thousands | |
Q2
23 | | |
Q2
22 | | |
Change | | |
H1
23 | | |
H1
22 | | |
Change | |
Income | |
| 632 | | |
| 186 | | |
| 446 | | |
| 1,134 | | |
| 430 | | |
| 704 | |
R&D expenses | |
| (1,875 | ) | |
| (5,747 | ) | |
| 3,872 | | |
| (3,579 | ) | |
| (9,512 | ) | |
| 5,933 | |
G&A expenses | |
| (1,304 | ) | |
| (1,531 | ) | |
| 227 | | |
| (2,501 | ) | |
| (3,773 | ) | |
| 1,272 | |
Total operating loss | |
| (2,547 | ) | |
| (7,092 | ) | |
| 4,545 | | |
| (4,946 | ) | |
| (12,855 | ) | |
| 7,909 | |
Finance result, net | |
| (128 | ) | |
| (129 | ) | |
| 1 | | |
| (136 | ) | |
| (190 | ) | |
| 54 | |
Net loss for the period | |
| (2,675 | ) | |
| (7,221 | ) | |
| 4,546 | | |
| (5,082 | ) | |
| (13,045 | ) | |
| 7,963 | |
Basic and diluted net loss per
share | |
| (0.04 | ) | |
| (0.19 | ) | |
| 0.15 | | |
| (0.08 | ) | |
| (0.34 | ) | |
| 0.26 | |
Net increase / (decrease) in cash
and cash equivalents | |
| 1,574 | | |
| (6,075 | ) | |
| 7,649 | | |
| 212 | | |
| (11,672 | ) | |
| 11,884 | |
Cash and cash equivalents as of June 30 | |
| 7,169 | | |
| 8,813 | | |
| (1,644 | ) | |
| 7,169 | | |
| 8,813 | | |
| (1,644 | ) |
Shareholders’ equity as of June 30 | |
| 6,126 | | |
| 6,862 | | |
| (736 | ) | |
| 6,126 | | |
| 6,862 | | |
| (736 | ) |
Financial Summary:
Income
is primarily driven by amounts received under our funded research collaboration with
Indivior, recognized as related costs are incurred. During the first half of 2023, income increased
by CHF 0.7 million to CHF 1.1 million compared to CHF 0.4 million in the first half of 2022. During the second quarter of 2023, income
increased by CHF 0.4 million to CHF 0.6 million compared to CHF 0.2 million in the second quarter of 2022.
R&D
expenses decreased by CHF 5.9 million to CHF 3.6 million in the first half of 2023 compared
to CHF 9.5 million in the first half of 2022 and by CHF 3.9 million to CHF 1.8 million in the second quarter of 2023 compared to CHF
5.7 million in the second quarter of 2022. The decrease in R&D expenses is primarily due to decreased dipraglurant related external
research and development activities.
G&A
expenses decreased by CHF 1.3 million to CHF 2.5 million in the first half of 2023 compared
to CHF 3.8 million in the first half of 2022, primarily due to reduced share-based service costs and decreased D&O insurance costs.
During the second quarter of 2023, G&A expenses decreased by CHF 0.2 million to CHF 1.3 million compared to CHF 1.5 million
in the second quarter of 2022, primarily due to decreased D&O insurance costs.
Our net
loss decreased by CHF 8.0 million to CHF 5.0 million in the first half of 2023 compared to CHF 13.0 million in the first half of 2022
and by CHF 4.5 million to CHF 2.7 million in the second quarter of 2023 compared to CHF 7.2 million in the second quarter of 2022. The
reduced net loss is primarily driven by reduced R&D expenses and to a lesser extent increased income.
Basic and
diluted loss per share decreased to CHF 0.08 for the first half of 2023 compared to CHF 0.34 for the first half of 2022. For the second
quarter of 2023, the basic and diluted loss per share
decreased
to CHF 0.04 compared to CHF 0.19 for the second quarter of 2022.
Cash and cash equivalents decreased to CHF 7.2
million at June 30, 2023, compared to CHF 8.8 million at June 30, 2022. The decrease of CHF 1.6 million is primarily due to
the cash used in our operating activities, partially offset by the proceeds from financing activities mainly related to equity offerings
executed on April 3, 2023 and to a lesser extent research funding from Indivior.
Half-Year 2023
Consolidated Financial Statements:
The half-year 2023
financial report can be found on the Company’s website in the investor/download section here.
Conference Call Details:
A conference call
will be held today, August 10, 2023, at 16:00 CEST (15:00 BST / 10:00 EDT / 07:00 PDT) to review the financial results.
Tim Dyer, Chief Executive Officer, Robert Lütjens, Head of Discovery - Biology and Mikhail Kalinichev, Head of Translational Science
will deliver a brief presentation followed by a Q&A session.
Joining the Conference Call:
| 1. | Participants
are required to register in advance of the conference using the link provided below. Upon
registering, each participant will be provided with Participant Dial-in numbers, and a unique
Personal PIN. |
| 2. | In
the 10 minutes prior to the call’s start time, participants will need to use the conference
access information provided in the e-mail received at the point of registering. Participants
may also use the call me feature instead of dialing the nearest dial in number. |
Online Registration:
https://register.vevent.com/register/BI3df82968423c4258930719a84f76d6bf
Webcast URL: https://edge.media-server.com/mmc/p/gp4h8rth
About Addex Therapeutics:
Addex Therapeutics is
a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available,
small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages
over conventional, non-allosteric molecules and may offer an improved therapeutic approach to conventional "orthosteric" small
molecule or biological drugs. Addex's allosteric modulator drug discovery platform targets receptors and other proteins that are recognized
as essential for therapeutic intervention. Addex's lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed
in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2 clinical trial for the treatment of epilepsy. Addex's second
clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in post-stroke
recovery. Indivior PLC has licensed Addex’s GABAB PAM program for the development of drug candidates, with a focus on substance
use disorder. Addex is also advancing a broad preclinical pipeline, which includes development of a range of GABAB PAMs for chronic cough,
mGlu7 NAM for stress related disorders, M4 PAM for schizophrenia and other forms of psychosis and mGlu2 NAM for mild neurocognitive
disorders and depression. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are
listed on the NASDAQ Capital Market, and trade under the ticker symbol "ADXN" on each exchange.
Contacts:
Tim Dyer
Chief Executive Officer
Telephone: +41 22 884 15 55
PR@addextherapeutics.com |
Mike Sinclair
Partner, Halsin Partners
+44 (0)7968 022075
msinclair@halsin.com |
Addex Forward Looking Statements:
This press release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of
proceeds of the offering. The words “may,” “will,” “could,” “would,” “should,”
“expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,”
“predict,” “project,” “potential,” “continue,” “target” and similar expressions
are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any
forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number
of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied
by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions.
These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’
Annual Report on Form 20-F for the year ended December 31, 2022, as filed with the SEC on March 30, 2023, the final prospectus
supplement and accompanying prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking
statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied
upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking
statements.
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