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
June 2024
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
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): 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thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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, 2023 filed with the Securities and Exchange Commission on
April 18, 2024 and updated in our prospectus (No.333-271611) amended on April 24, 2024. 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: June 6, 2024 |
|
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 March 31, 2024 and December 31, 2023 |
2 |
Unaudited
Interim Condensed Consolidated Statements of Comprehensive Loss for the three-month periods ended March 31, 2023 and 2024 |
3
|
Unaudited
Interim Condensed Consolidated Statements of Changes in Equity for the three-month period ended March 31, 2023 |
4 |
Unaudited
Interim Condensed Consolidated Statements of Changes in Equity for the three-month period ended March 31, 2024 |
5 |
Unaudited
Interim Condensed Consolidated Statements of Cash Flows for the three-month periods ended March 31, 2023 and 2024 |
6 |
Unaudited
Notes to the Interim Condensed Consolidated Financial Statements for the three-month period ended March 31, 2024 |
7 |
Addex
Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements
Unaudited
Interim Condensed Consolidated Balance Sheets
as of March 31,
2024, and December 31, 2023
|
|
Notes |
|
March 31,
2024 |
|
|
December 31,
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts in
Swiss francs |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
6 |
|
|
1,627,832 |
|
|
|
3,865,481 |
|
Other financial assets |
|
7/12 |
|
|
2,380 |
|
|
|
848 |
|
Trade and other receivables |
|
7 |
|
|
116,246 |
|
|
|
110,361 |
|
Contract asset |
|
7 |
|
|
108,801 |
|
|
|
40,907 |
|
Prepayments |
|
7 |
|
|
651,567 |
|
|
|
217,008 |
|
Total |
|
|
|
|
2,506,826 |
|
|
|
4,234,605 |
|
Assets classified as held for sale |
|
20 |
|
|
789,880 |
|
|
|
- |
|
Total current assets |
|
|
|
|
3,296,706 |
|
|
|
4,234,605 |
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
|
|
|
|
Right-of-use assets |
|
8 |
|
|
32,317 |
|
|
|
330,332 |
|
Property, plant and equipment |
|
9 |
|
|
- |
|
|
|
22,604 |
|
Non-current financial assets |
|
10 |
|
|
7,070 |
|
|
|
54,344 |
|
Total non-current assets |
|
|
|
|
39,387 |
|
|
|
407,280 |
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
|
|
|
3,336,093 |
|
|
|
4,641,885 |
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
|
|
Current lease liabilities |
|
|
|
|
12,239 |
|
|
|
273,956 |
|
Payables and accruals |
|
11 |
|
|
3,314,143 |
|
|
|
2,384,350 |
|
Deferred income |
|
|
|
|
- |
|
|
|
234,978 |
|
Total |
|
|
|
|
3,326,382 |
|
|
|
2,893,284 |
|
Liabilities directly associated with
assets classified as held for sale |
|
20 |
|
|
1,328,218 |
|
|
|
- |
|
Total current liabilities |
|
|
|
|
4,654,600 |
|
|
|
2,893,284 |
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
|
|
|
|
Non-current lease liabilities |
|
|
|
|
22,946 |
|
|
|
70,380 |
|
Retirement benefits obligations |
|
14 |
|
|
31,534 |
|
|
|
443,524 |
|
Deferred income |
|
|
|
|
- |
|
|
|
89,232 |
|
Total non-current liabilities |
|
|
|
|
54,480 |
|
|
|
603,136 |
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
Share capital |
|
12 |
|
|
1,843,545 |
|
|
|
1,843,545 |
|
Share premium |
|
12 |
|
|
266,391,611 |
|
|
|
266,194,689 |
|
Other equity |
|
12 |
|
|
64,620,223 |
|
|
|
64,620,223 |
|
Treasury shares reserve |
|
12 |
|
|
(875,112 |
) |
|
|
(909,566 |
) |
Other reserves |
|
|
|
|
30,152,127 |
|
|
|
29,814,816 |
|
Accumulated deficit |
|
|
|
|
(363,505,381 |
) |
|
|
(360,418,242 |
) |
Total equity |
|
|
|
|
(1,372,987 |
) |
|
|
1,145,465 |
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity |
|
|
|
|
3,336,093 |
|
|
|
4,641,885 |
|
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
periods ended March 31, 2024 and 2023
| |
| |
For the
three months ended March 31, | |
| |
Notes | |
2024 | | |
2023* | |
| |
| |
| | |
| |
| |
| |
Amounts
in Swiss francs | |
Revenue from contract with customer | |
15 | |
| 233,480 | | |
| 500,892 | |
Other income | |
16 | |
| 1,430 | | |
| 1,155 | |
| |
| |
| | | |
| | |
Operating costs | |
| |
| | | |
| | |
Research and development | |
| |
| (245,125 | ) | |
| (255,368 | ) |
General and administration | |
| |
| (777,877 | ) | |
| (614,335 | ) |
Total operating costs | |
17 | |
| (1,023,002 | ) | |
| (869,703 | ) |
| |
| |
| | | |
| | |
Operating loss | |
| |
| (788,092 | ) | |
| (367,656 | ) |
| |
| |
| | | |
| | |
Finance income | |
| |
| 53,525 | | |
| 23,826 | |
Finance expense | |
| |
| (611 | ) | |
| (26,179 | ) |
Finance result | |
19 | |
| 52,914 | | |
| (2,353 | ) |
| |
| |
| | | |
| | |
Net loss before tax | |
| |
| (735,178 | ) | |
| (370,009 | ) |
Income tax expense | |
| |
| - | | |
| - | |
Net loss from continuing operations | |
| |
| (735,178 | ) | |
| (370,009 | ) |
Net loss from discontinued operations
(attributable to equity holders of the Group) | |
20 | |
| (2,351,961 | ) | |
| (2,037,160 | ) |
Net loss for the period | |
| |
| (3,087,139 | ) | |
| (2,407,169 | ) |
| |
| |
| | | |
| | |
Basic and diluted loss per share | |
| |
| | | |
| | |
From continuing operations | |
| |
| (0.01 | ) | |
| (0.01 | ) |
From discontinued operations | |
| |
| (0.02 | ) | |
| (0.03 | ) |
Total Basic and diluted loss per share for loss attributable
to the ordinary equity holders of the Company | |
21 | |
| (0.03 | ) | |
| (0.04 | ) |
| |
| |
| | | |
| | |
Other comprehensive loss | |
| |
| | | |
| | |
Items that will never be reclassified to profit and loss: | |
| |
| | | |
| | |
Remeasurements of retirement benefits obligation | |
| |
| (49,845 | ) | |
| (30,641 | ) |
Items that may be classified subsequently to profit and loss: | |
| |
| | | |
| | |
Exchange difference on translation of
foreign operations | |
| |
| 1,128 | | |
| 81 | |
Other comprehensive loss for the
period, net of tax | |
| |
| (48,717 | ) | |
| (30,560 | ) |
| |
| |
| | | |
| | |
Total comprehensive loss for the
period | |
| |
| (3,135,856 | ) | |
| (2,437,729 | ) |
From continuing operations | |
| |
| (736,547 | ) | |
| (371,463 | ) |
From discontinued operations | |
| |
| (2,399,309 | ) | |
| (2,066,265 | ) |
*
The comparative information has been re-presented due to discontinued operations that have
been reclassed to the financial line called “Net loss from discontinued operations” (note 20). In the notes of this unaudited
interim condensed consolidated financial statements related to comprehensive loss information, an asterisk will remind when comparative
information has been re-presented.
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 March 31, 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 |
|
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 March 31, 2024
|
|
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, 2024 |
|
|
|
|
1,843,545 |
|
|
|
266,194,689 |
|
|
|
64,620,223 |
|
|
|
(909,566 |
) |
|
|
(659,870 |
) |
|
|
30,474,686 |
|
|
|
(360,418,242 |
) |
|
|
1,145,465 |
|
Net loss for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3,087,139 |
) |
|
|
(3,087,139 |
) |
Other comprehensive
loss for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,128 |
|
|
|
(49,845 |
) |
|
|
- |
|
|
|
(48,717 |
) |
Total
comprehensive loss for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,128 |
|
|
|
(49,845 |
) |
|
|
(3,087,139 |
) |
|
|
(3,135,856 |
) |
Cost of pre-funded warrants exercised |
|
|
|
|
- |
|
|
|
(3,647 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3,647 |
) |
Value of share-based services |
|
13 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
386,028 |
|
|
|
- |
|
|
|
386,028 |
|
Movement in treasury shares: |
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales under liquidity agreement |
|
|
|
|
- |
|
|
|
(2,417 |
) |
|
|
- |
|
|
|
3,947 |
|
|
|
. |
|
|
|
- |
|
|
|
- |
|
|
|
1,530 |
|
Sales agency agreement |
|
|
|
|
- |
|
|
|
204,750 |
|
|
|
- |
|
|
|
30,507 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
235,257 |
|
Costs under sale agency agreement |
|
|
|
|
- |
|
|
|
(1,764 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,764 |
) |
Balance as of March 31,
2024 |
|
|
|
|
1,843,545 |
|
|
|
266,391,611 |
|
|
|
64,620,223 |
|
|
|
(875,112 |
) |
|
|
(658,742 |
) |
|
|
30,810,869 |
|
|
|
(363,505,381 |
) |
|
|
(1,372,987 |
) |
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 three-month
periods ended March 31, 2024 and 2023
| |
| |
For the
three months ended March 31, | |
| |
Notes | |
2024 | | |
2023 | |
| |
| |
| | |
| |
| |
| |
Amounts
in Swiss francs | |
Net loss for the period | |
| |
| (3,087,139 | ) | |
| (2,407,169 | ) |
Adjustments for: | |
| |
| | | |
| | |
Depreciation | |
8/9 | |
| 70,360 | | |
| 75,779 | |
Value of share-based services | |
13 | |
| 386,028 | | |
| 431,196 | |
Post-employment benefits | |
| |
| (28,327 | ) | |
| (30,641 | ) |
Finance cost net | |
| |
| (98,152 | ) | |
| 10,826 | |
Increase in other financial assets | |
7 | |
| (1,532 | ) | |
| (957 | ) |
Decrease / (increase) in trade and other receivables | |
7 | |
| (5,885 | ) | |
| 186,462 | |
Increase in contract asset | |
7 | |
| (67,894 | ) | |
| (19,616 | ) |
Increase in prepayments | |
7 | |
| (434,559 | ) | |
| (610,525 | ) |
Increase in payables and accruals | |
11 | |
| 931,159 | | |
| 5,208 | |
Decrease in deferred income | |
| |
| (324,210 | ) | |
| - | |
Assets recorded as held for sale | |
20 | |
| (186,522 | ) | |
| - | |
Liabilities recorded as held for sale | |
20 | |
| 652,294 | | |
| - | |
Net cash used in operating activities | |
| |
| (2,194,379 | ) | |
| (2,359,437 | ) |
| |
| |
| | | |
| | |
Cash flows from investing activities | |
| |
| | | |
| | |
Purchase of property, plant and equipment | |
9 | |
| - | | |
| (2,469 | ) |
Net cash used in investing activities | |
| |
| - | | |
| (2,469 | ) |
| |
| |
| | | |
| | |
Cash flows from financing activities | |
| |
| | | |
| | |
Costs paid on sale of treasury shares – shelf registration | |
| |
| (2,782 | ) | |
| (2,356 | ) |
Costs paid on sale of pre-funded warrants | |
| |
| - | | |
| (5,495 | ) |
Costs paid on exercise of pre-funded warrants | |
| |
| (2,230 | ) | |
| - | |
Sales under sale agency agreement & liquidity agreement
movements | |
12 | |
| 236,787 | | |
| 1,177,738 | |
Costs paid on sale of treasury shares under sale agency agreement | |
| |
| (1,764 | ) | |
| (8,826 | ) |
Cost paid on issue of treasury shares | |
12 | |
| - | | |
| (33,247 | ) |
Principal element of lease payment | |
| |
| (66,735 | ) | |
| (114,017 | ) |
Interest received | |
19 | |
| 7,555 | | |
| 23,826 | |
Interest paid | |
19 | |
| (6,283 | ) | |
| (9,280 | ) |
Net cash from financing activities | |
| |
| 164,548 | | |
| 1,028,343 | |
| |
| |
| | | |
| | |
Decrease in cash and cash equivalents | |
| |
| (2,029,831 | ) | |
| (1,333,563 | ) |
| |
| |
| | | |
| | |
Cash and cash equivalents at the beginning of the period | |
6 | |
| 3,865,481 | | |
| 6,957,086 | |
Asset recorded as held for sale (cash) | |
20 | |
| (305,809 | ) | |
| - | |
Exchange difference on cash and cash equivalents | |
| |
| 97,991 | | |
| (28,651 | ) |
| |
| |
| | | |
| | |
Cash and cash equivalents at the
end of the period | |
6 | |
| 1,627,832 | | |
| 5,594,872 | |
The Group reports
significant non-cash items related to the fair value of the share-based services (note 13) and the right of use assets (note 8). The
funds received from the grant Eurostars/Innosuisse and the associate deferred income have been recorded as asset and liability held for
sale respectively (notes 16 and 20).
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
period ended March 31, 2024
(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 biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders.
The Company is
a Swiss stockholding corporation domiciled c/o Addex Pharma SA, Chemin des Aulx 12, CH 1228 Plan-les-Ouates, Geneva, Switzerland and
the parent company of Addex Pharma SA, Addex Pharmaceuticals France SAS, Neurosterix Pharma Sàrl, Neurosterix SA and Addex Pharmaceuticals
Inc. The Groups principal place of business is Chemin des Mines 9, CH 1202 Geneva, Switzerland. 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 June 5, 2024.
2. Basis of preparation
These interim condensed
consolidated financial statements for the three-month period ended March 31, 2024, 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, 2023.
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, 2023.
A number of new
or amended standards and interpretations became applicable for financial reporting periods beginning on or after January 1, 2024.
Of the latter, the Group noted the publication of IFRS S1 (General requirement for disclosure of sustainability-related financial information)
and IFRS S2 (climate – related Disclosures). The Group concluded that those new IFRS standards were not relevant as the Group did
not opt for the publication of a sustainability report in accordance with Six Swiss Exchange listing rules.
There are other
new standards, amendments and interpretations which have been deemed by the Group as currently not relevant, hence are not listed or
discussed further here.
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 2024 presentation. In particular, we re-presented the unaudited
interim condensed consolidated statements of comprehensive loss of the first quarter of 2023, in order to reclass discontinued operations
in accordance with IFRS 5 (note 20). In addition, the ADS numbers previously disclosed have been amended following the change in ADS
ratio executed on October 23, 2023, from one ADS to six shares to a new ratio of one ADS to one hundred and twenty shares. The ADS
ratio change had the same effect as a one to twenty ADS reverse split and except as otherwise indicated, all information in these consolidated
financial statements gives retroactive effect to the ADS Ratio Change.
Addex Therapeutics
│ Unaudited Interim Condensed Consolidated Financial Statements │Notes
3. Material 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:
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,
licensing certain of its research and development stage products and selling its allosteric modulator drug discovery technology platform
and a portfolio of preclinical programs. 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 consolidated financial
statements will be sufficient to fund its operations and meet all of its obligations as they fall due, through 2026. 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 including health pandemics
and geopolitical risks. 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, closing 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.
The Business
of the Group could be adversely affected by health pandemics and geopolitical risks
The
business of the Group could be adversely affected by health epidemics and geopolitical risks in regions where the Group
or partners have concentrations of clinical trial sites or other business operations and could cause significant disruption in the operations
of third-party manufacturers and CROs upon whom the Group or partners rely. Health pandemics may pose the risk that the Group, employees,
contractors, collaborators, and partners may be prevented from conducting certain pre-clinical tests, clinical trials or other business
activities for an indefinite period of time, including due to travel restrictions, quarantines, “stay-at-home” and “shelter-in-place”
orders or shutdowns that have been or may in the future be requested or mandated by governmental authorities. For example, the COVID-19
pandemic has impacted and could in the future impact the business of the Group and ongoing and planning clinical trials led by the Group
or partners, including as a result of delays or difficulties in clinical site initiation, difficulties in recruiting and retaining clinical
site investigators and clinical site staff and interruption of the clinical supply chain or key clinical trial activities, such as clinical
trial site monitoring, and supply chain interruptions caused by restrictions for the supply of materials for drug candidates or other
materials necessary to manufacture product to conduct clinical and preclinical tests. Geopolitical risks such as Russia-Ukraine war or
Middle East conflict may create global security concerns including the possibility of an expanded regional or global conflict and potential
ramifications such as 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, Russia-Ukraine war 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.
Discontinued
operations, assets and liabilities held for sale related to the Neurosterix Transaction
During
the first quarter of 2024, it became highly probable that the Group would sell a part of its business constituted by its
allosteric modulator drug discovery technology platform and a portfolio of preclinical programs (see note 20). As a consequence, the
group recorded assets held for sale, liabilities held for sale as of March 31, 2024 and recognized discontinued operations in the
financial line of the statements of comprehensive loss called “net loss from discontinued operations” for the three month-period
ended March 31, 2024 and 2023 respectively, in accordance with IFRS 5. The Group identified cash flows from discontinued operations
for the three month-period ended March 31, 2024 and 2023, respectively (see note 20). The identification of assets held for sale,
liabilities held for sale and discontinued operations may require some degree of judgement.
Addex Therapeutics
│ Unaudited Interim Condensed Consolidated Financial Statements │Notes
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.
Accrued research
and development costs
The Group records
accrued expenses for estimated costs of research and development activities conducted by third party service providers. The Group records
accrued expenses for estimated costs of research and development activities 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. Accrued expenses
for these costs are recorded based on the estimated amount of work completed in accordance with agreements established with these third
parties. Due to the nature of estimates, the Group may be required to make changes to the estimates after a reporting period 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 preclinical 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.
Equity instruments
The group records
in equity the prefunded warrants sold to investors and the warrants granted to investors at a fair value whose valuation is calculated
using Black - Scholes model.
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.
Addex Therapeutics
│ Unaudited Interim Condensed Consolidated Financial Statements │Notes
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 period ended March 31, 2024 and 2023 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 March 31, |
|
|
|
2024 |
|
|
2023* |
|
Collaborative research funding |
|
|
233,480 |
|
|
|
500,892 |
|
Other service income |
|
|
1,430 |
|
|
|
1,155 |
|
Total |
|
|
234,910 |
|
|
|
502,047 |
|
Analysis of revenue
from contract with customer and other income by major counterparties is detailed as follows:
|
|
For
the three months Ended March 31, |
|
|
|
2024 |
|
|
2023* |
|
Indivior PLC |
|
|
233,480 |
|
|
|
500,892 |
|
Other counterparties |
|
|
1,430 |
|
|
|
1,155 |
|
Total |
|
|
234,910 |
|
|
|
502,047 |
|
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:
| |
March 31,
2024 | | |
December 31,
2023 | |
Switzerland | |
| 39,037 | | |
| 406,946 | |
France | |
| 350 | | |
| 334 | |
Total | |
| 39,387 | | |
| 407,280 | |
The geographical
analysis of operating costs is as follows:
|
|
For
the three months
Ended March 31, |
|
|
|
2024 |
|
|
2023* |
|
Switzerland |
|
|
1,021,074 |
|
|
|
851,459 |
|
United States of America |
|
|
1,646 |
|
|
|
17,137 |
|
France |
|
|
282 |
|
|
|
1,107 |
|
Total operating costs (note 17) |
|
|
1,023,002 |
|
|
|
869,703 |
|
The capital expenditure
during the three-month period ended March 31, 2024 is nil (CHF 2,469 for the three-month period ended March 31, 2023).
6. Cash and
cash equivalents
| |
March 31,
2024 | | |
December 31,
2023 | |
Cash at bank and on hand | |
| 1,627,832 | | |
| 3,865,481 | |
Total cash and cash equivalents | |
| 1,627,832 | | |
| 3,865,481 | |
Addex Therapeutics │ Unaudited Interim
Condensed Consolidated Financial Statements │Notes
Split by currency:
| |
March 31,
2024 | | |
December 31,
2023 | |
CHF | |
| 29.99 | % | |
| 39.88 | % |
USD | |
| 47.23 | % | |
| 56.22 | % |
EUR | |
| 17.71 | % | |
| 3.03 | % |
GBP | |
| 5.07 | % | |
| 0.87 | % |
Total | |
| 100.00 | % | |
| 100.00 | % |
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 March 31, 2024 and December 31, 2023.
7. Other current assets
| |
March 31,
2024 | | |
December 31,
2023 | |
Other financial assets | |
| 2,380 | | |
| 848 | |
Trade and other receivables | |
| 116,246 | | |
| 110,361 | |
Contract asset (Indivior PLC) | |
| 108,801 | | |
| 40,907 | |
Prepayments | |
| 651,567 | | |
| 217,008 | |
Total other current assets | |
| 878,994 | | |
| 369,124 | |
Prepayments increased by CHF 0.5 million as of
March 31, 2024 compared to December 31, 2023 primarily due to retirement benefits paid annually at the beginning of the year.
Prepayments related to retirement benefits of employees transferred to Neurosterix on April 2, 2024 are not considered as an asset
held for sale. 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. The Group has considered that the
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 March 31, 2024 and December 31, 2023.
8. Right-of-use assets
Year ended December 31,
2023 | |
Properties | | |
Equipment | | |
Total | |
Opening net book amount | |
| 353,097 | | |
| 4,516 | | |
| 357,613 | |
Depreciation charge | |
| (277,885 | ) | |
| (2,708 | ) | |
| (280,593 | ) |
Effect of lease modifications | |
| 253,312 | | |
| - | | |
| 253,312 | |
Closing net book amount | |
| 328,524 | | |
| 1,808 | | |
| 330,332 | |
As of December 31, 2023 | |
Properties | | |
Equipment | | |
Total | |
Cost | |
| 1,725,162 | | |
| 13,542 | | |
| 1,738,704 | |
Accumulated depreciation | |
| (1,396,638 | ) | |
| (11,734 | ) | |
| (1,408,372 | ) |
Net book value | |
| 328,524 | | |
| 1,808 | | |
| 330,332 | |
Period ended March 31, 2024 | |
Properties | | |
Equipment | | |
Total | |
Opening net book amount | |
| 328,524 | | |
| 1,808 | | |
| 330,332 | |
Depreciation charge | |
| (66,066 | ) | |
| (677 | ) | |
| (66,743 | ) |
Assets classified as held for sale | |
| (230,141 | ) | |
| (1,131 | ) | |
| (231,272 | ) |
Closing net book amount | |
| 32,317 | | |
| - | | |
| 32,317 | |
As of March 31, 2024 | |
Properties | | |
Equipment | | |
Total | |
Cost | |
| 95,110 | | |
| - | | |
| 95,110 | |
Accumulated depreciation | |
| (62,793 | ) | |
| - | | |
| (62,793 | ) |
Net book value | |
| 32,317 | | |
| - | | |
| 32,317 | |
Addex Therapeutics │
Unaudited Interim Condensed Consolidated Financial Statements │Notes
The gross value of the right of use assets decreased
by CHF 1,643,594 between the periods ended December 31, 2023 and March 31, 2024. The decrease is due to the transfer of assets
to Neurosterix recorded as held for sale.
9. Property, plant and equipment
Year ended December 31, 2023 | |
Equipment | | |
Furniture &
fixtures | | |
Chemical library | | |
Total | |
Opening net book amount | |
| 41,121 | | |
| - | | |
| - | | |
| 41,121 | |
Additions | |
| 6,842 | | |
| - | | |
| - | | |
| 6,842 | |
Depreciation charge | |
| (25,359 | ) | |
| - | | |
| - | | |
| (25,359 | ) |
Closing net book amount | |
| 22,604 | | |
| - | | |
| - | | |
| 22,604 | |
As of December 31, 2023 | |
Equipment | | |
Furniture &
fixtures | | |
Chemical library | | |
Total | |
Cost | |
| 1,721,251 | | |
| 7,564 | | |
| 1,207,165 | | |
| 2,935,980 | |
Accumulated depreciation | |
| (1,698,647 | ) | |
| (7,564 | ) | |
| (1,207,165 | ) | |
| (2,913,376 | ) |
Net book value | |
| 22,604 | | |
| - | | |
| - | | |
| 22,604 | |
Period ended March 31, 2024 | |
Equipment | | |
Furniture &
fixtures | | |
Chemical library | | |
Total | |
Opening net book amount | |
| 22,604 | | |
| - | | |
| - | | |
| 22,604 | |
Depreciation charge | |
| (3,617 | ) | |
| - | | |
| - | | |
| (3,617 | ) |
Assets classified as held for sale | |
| (18,987 | ) | |
| - | | |
| - | | |
| (18,987 | ) |
Closing net book amount | |
| - | | |
| - | | |
| - | | |
| - | |
As of March 31, 2024 | |
Equipment | | |
Furniture &
fixtures | | |
Chemical library | | |
Total | |
Cost | |
| 83,502 | | |
| - | | |
| - | | |
| 83,502 | |
Accumulated depreciation | |
| (83,502 | ) | |
| - | | |
| - | | |
| (83,502 | ) |
Net book value | |
| - | | |
| - | | |
| - | | |
| - | |
The gross value of property, plant and equipment
decreased by CHF 2,852,478 between the periods ended December 31, 2023 and March 31, 2024. The decrease includes CHF 2,596,458
related to assets transferred to Neurosterix recorded as held for sale and CHF 256,020 related to disposals.
10. Non-current financial assets
| |
March 31,
2024 | | |
December 31,
2023 | |
Security rental deposits | |
| 7,070 | | |
| 54,344 | |
Total non-current financial assets | |
| 7,070 | | |
| 54,344 | |
11. Payables and accruals
| |
March 31,
2024 | | |
December 31,
2023 | |
Trade payables | |
| 1,627,961 | | |
| 984,384 | |
Social security and other taxes | |
| 78,310 | | |
| 164,609 | |
Accrued expenses | |
| 1,607,872 | | |
| 1,235,357 | |
Total payables and accruals | |
| 3,314,143 | | |
| 2,384,350 | |
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 increased by CHF 0.9 million as of March 31, 2024 compared to December 31, 2023 mainly
due to delayed payments and increased legal fees related to the Neurosterix Transaction. The carrying amounts of payables do not materially
differ from their fair values, due to their short-term nature.
Addex Therapeutics │
Unaudited Interim Condensed Consolidated Financial Statements │Notes
12. Share capital
| |
Number
of shares | |
| |
Common shares | | |
Treasury shares | | |
Total | |
Balance as of January 1, 2023 | |
| 115,348,311 | | |
| (38,214,291 | ) | |
| 77,134,020 | |
Sale of shares under sale agency agreement | |
| - | | |
| 3,742,506 | | |
| 3,742,506 | |
Net purchase of shares under liquidity
agreement | |
| - | | |
| (5,235 | ) | |
| (5,235 | ) |
Balance as of March 31, 2023 | |
| 115,348,311 | | |
| (34,477,020 | ) | |
| 80,871,291 | |
Shares reclassed as treasury shares under IFRS 2 | |
| - | | |
| (17,438,883 | ) | |
| (17,438,883 | ) |
Balance as of March 31, 2023 IFRS 2 | |
| 115,348,311 | | |
| (51,915,903 | ) | |
| 63,432,408 | |
| |
Number
of shares | |
| |
Common shares | | |
Treasury shares | | |
Total | |
Balance as of January 1, 2024 | |
| 184,354,496 | | |
| (59,159,103 | ) | |
| 125,195,393 | |
Sale of shares under sale agency agreement | |
| - | | |
| 3,050,665 | | |
| 3,050,665 | |
Net sale of shares under liquidity agreement | |
| - | | |
| 19,999 | | |
| 19,999 | |
Balance as of March 31, 2024 | |
| 184,354,496 | | |
| (56,088,439 | ) | |
| 128,266,057 | |
Shares reclassed as treasury shares under IFRS 2 | |
| - | | |
| (29,958,807 | ) | |
| (29,958,807 | ) |
Balance as of March 31, 2024 IFRS 2 | |
| 184,354,496 | | |
| (86,047,246 | ) | |
| 98,307,250 | |
As of March 31, 2024, 128,266,057 shares
were outstanding excluding 56,088,439 treasury shares directly held by Addex Pharma SA and including 29,958,807 outstanding shares benefiting
from our DSPPP, considered as treasury shares under IFRS 2 (note 13). As of March 31, 2023, 80,871,291 shares were outstanding excluding
34,477,020 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 have a nominal value of CHF 0.01.
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 March 31, 2024, 152,073 (December 31, 2023: 172,072) treasury shares are recorded
under this agreement in the treasury share reserve and CHF 2,380 (December 31, 2023: CHF 848) is recorded in other financial assets.
During the three-month period ended March 31,
2024, the Group sold 3,050,665 treasury shares under the sale agency agreement with Kepler Cheuvreux at an average price of CHF 0.077
per share for gross proceeds of CHF 235,257 (during the three-month period ended March 31, 2023, the Group sold 3,742,506 treasury
shares at an average price of CHF 0.31 per share for gross proceeds of CHF 1,176,781).
On February 20, 2024, in accordance with
Swiss law, the company registered in the commercial register 6,120,000 new shares issued out of conditional capital from December 12,
2023 to December 31, 2023 following the exercise of pre-funded warrants granted to one institutional investor on April 3, 2023.
13. Share-based compensation
The total share-based compensation expense for
equity incentive units recognized as continuing operating costs in the statement of comprehensive loss for the three-month period ended
March 31, 2024 amounted to CHF 58,347 compared to CHF 64,673 for the three-month period ended March 31, 2023. During the same
period, the total share-based compensation expense recognized in the statement of comprehensive loss under “net loss from discontinued
operations” amounted to CHF 327,681 and CHF 366,523, respectively (see note 20).
As of March 31, 2024, 8,009,470 options
were outstanding (December 31, 2023: 1,570,346). On January 8, 2024, the Group granted 6,439,124 options at an exercise price
of CHF 0.05 with vesting over 4 years and a 10-year exercise period. As of March 31, 2024 and December 31, 2023, there are
no equity sharing certificates (ESCs) outstanding.
As of March 31, 2024, and December 31,
2023, 29,958,807 shares benefiting from our Deferred Strike Price Payment Plan (DSPPP) were outstanding. 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
March 31, | |
| |
| 2024 | | |
| 2023* | |
Current service cost | |
| (3,150 | ) | |
| (3,333 | ) |
Past service cost | |
| 1,070 | | |
| 1,348 | |
Interest cost | |
| (1,795 | ) | |
| (2,349 | ) |
Interest income | |
| 1,633 | | |
| 2,266 | |
Company pension amount (note 18) | |
| (2,242 | ) | |
| (2,068 | ) |
The company pension costs recognized as continuing
operating costs in the statement of comprehensive loss for the three-month periods ended March 31, 2024 and March 31, 2023
were close to nil. During the same period, the total pension costs recognized in the financial line of the statement of comprehensive
loss called “net loss from discontinued operations” amounted to CHF 42,493 and CHF 39,217 respectively.
The amounts recognized in the balance sheet are
determined as follows:
| |
March 31,
2024 | | |
December 31,
2023 | |
Defined benefit obligation | |
| (168,997 | ) | |
| (9,138,045 | ) |
Fair value of plan assets | |
| 137,463 | | |
| 8,694,521 | |
Retirement benefit obligation | |
| (31,534 | ) | |
| (443,524 | ) |
Retirement benefit obligation decreased by CHF
0.4 million as of March 31, 2024 compared to December 31, 2023 because CHF 0.4 million has been recorded as liabilities held
for sale following the Neurosterix Transaction (note 20).
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 Cough. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.
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.
Addex Therapeutics │
Unaudited Interim Condensed Consolidated Financial Statements │Notes
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 and duration of two years with a funding
of USD 4 million over the period for the Group’s R&D costs incurred, that can be extended by twelve-month increments. 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 was 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 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 agreement with Indivior has been extended until June 30,
2024 and Indivior committed additional research funding of CHF 2.7 million including CHF 1.1 million expected to be paid to the Group
and CHF 1.6 million paid directly by Indivior to third party suppliers that are supporting the funded research program.
For the three-month period ended March 31,
2024, the Group recognized CHF 0.2 million as revenue in continuing operations (for the three-month period ended March 31, 2023:
CHF 0.5 million) and recorded CHF 0.1 million in contract asset as of March 31, 2024 (December 31, 2023: CHF 0.1 million relating
to contract assets and trade receivables).
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
for the three-month period ended March 31, 2024 and 2023.
16. Other income
Under grant agreements 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.
In July 2019, the Group was awarded a grant
of CHF 0.5 million by Eurostars/Innosuisse to support the mGlu7 NAM program totally recognized as income as of December 31, 2021.
In
September 2023, the Group was awarded a grant of CHF 0.5 million by Eurostars/Innosuisse to support the mGlu2 NAM program of which
CHF 0.3 million were received in December 2023. As of April 2, 2024, following the Neurosterix Transaction, other income
recognized through this grant in the first quarter of 2024 has been reclassed in the statements of comprehensive loss under “net
loss from discontinued operations”. The remaining funds and the associated deferred income amount of CHF 0.3 million as of March 31,
2024 has been recorded as assets and liabilities held for sale, respectively (see note 20).
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
March 31, | |
| |
| 2024 | | |
| 2023* | |
Staff costs (note 18) | |
| 68,682 | | |
| 54,910 | |
Depreciation (notes 8/9) | |
| 2,938 | | |
| 2,938 | |
External research and development costs | |
| 179,110 | | |
| 199,902 | |
Patent maintenance and registration costs | |
| 55,539 | | |
| 58,073 | |
Professional fees | |
| 452,010 | | |
| 293,528 | |
D&O insurance | |
| 51,049 | | |
| 156,315 | |
Other operating costs | |
| 213,674 | | |
| 104,037 | |
Total operating costs | |
| 1,023,002 | | |
| 869,703 | |
The evolution of the total operating costs is
mainly driven by professional fees and other operating costs.
During the three-month period ended March 31,
2024, total operating costs recognized as continuing operating costs increased by CHF 0.2 million compared to the same period ended March 31,
2023, primarily due to increased legal fees. During the same period, total operating costs recognized in the statement of comprehensive
loss under “net loss from discontinued operations” remained stable at CHF 2.0 million (see note 20).
18. Staff costs
| |
For
the three months Ended
March 31, | |
| |
2024 | | |
2023* | |
Wages and salaries | |
| 54,284 | | |
| 41,162 | |
Social charges and insurances | |
| 6,210 | | |
| 4,805 | |
Value of share-based services | |
| 5,946 | | |
| 6,875 | |
Retirement benefit (note 14) | |
| 2,242 | | |
| 2,068 | |
Total staff costs | |
| 68,682 | | |
| 54,910 | |
During the three-month period ended March 31,
2024, total staff costs recognized as continuing operating costs remained stable compared to the same period ended March 31, 2023.
During the same period, total staff costs recognized in the financial line of the statement of comprehensive loss called “net loss
from discontinued operations” increased by CHF 0.1 million (see note 20).
19. Finance result, net
| |
For
the three months Ended
March 31, | |
| |
2024 | | |
2023* | |
Interest income | |
| 7,571 | | |
| 23,826 | |
Interest cost | |
| (146 | ) | |
| - | |
Interest expense on leases | |
| (465 | ) | |
| (609 | ) |
Foreign exchange (losses)/gains, net | |
| 45,954 | | |
| (25,570 | ) |
Finance result, net | |
| 52,914 | | |
| (2,353 | ) |
20. Discontinued operations
On February 8, 2024, the Group signed a
non-binding term sheet with Perceptive Advisors related to the divestment of part of its business constituted by its allosteric modulator
drug discovery technology platform and a portfolio of preclinical programs. On April 2, 2024, the sale became effective (see note
23).
As the sale became highly probable during the
first quarter of 2024, the Group has identified assets and liabilities held for sale as of March 31, 2024 and discontinued operations
in the first quarter of 2024 with its comparative related to the first quarter of 2023.
Addex Therapeutics │ Unaudited Interim
Condensed Consolidated Financial Statements │Notes
Financial performance of discontinued operations:
| |
For
the three months Ended
March 31, | |
| |
2024 | | |
2023 | |
Other income | |
| 38,401 | | |
| - | |
Research and development | |
| (1,320,098 | ) | |
| (1,459,609 | ) |
General and administration | |
| (636,281 | ) | |
| (572,239 | ) |
Total operating costs | |
| (1,956,379 | ) | |
| (2,031,848 | ) |
| |
| | | |
| | |
Operating loss | |
| (1,917,978 | ) | |
| (2,031,848 | ) |
| |
| | | |
| | |
Finance expense | |
| (5,672 | ) | |
| (5,311 | ) |
Net loss before tax | |
| (1,923,650 | ) | |
| (2,037,159 | ) |
Income tax expense | |
| - | | |
| - | |
Net loss from discontinued operations | |
| (1,923,650 | ) | |
| (2,037,159 | ) |
Legal fees expenses related to the sale
of discontinued operations | |
| (428,311 | ) | |
| - | |
Total net loss from discontinued
operations | |
| (2,351,961 | ) | |
| (2,037,159 | ) |
Operating costs of discontinued operations:
| |
For
the three months Ended
March 31, | |
| |
2024 | | |
2023 | |
Staff costs | |
| 1,368,966 | | |
| 1,288,517 | |
Depreciation | |
| 67,422 | | |
| 72,841 | |
External research and development costs | |
| 331,678 | | |
| 508,880 | |
Laboratory consumables | |
| 17,735 | | |
| 69,622 | |
Patent maintenance and registration costs | |
| 62,563 | | |
| 4,269 | |
Professional fees | |
| 38,271 | | |
| - | |
Short-term leases | |
| 8,329 | | |
| 8,216 | |
D&O insurance | |
| - | | |
| - | |
Other operating costs | |
| 61,415 | | |
| 79,503 | |
Total discontinued operating costs | |
| 1,956,379 | | |
| 2,031,848 | |
Discontinued operating costs primarily driven
by staff and external research and development costs remained stable at CHF 2.0 million for the three-month periods closed on March 31,
2024 and 2023.
Assets classified as held for sale:
| |
March 31,
2024 | |
Cash and cash equivalents | |
| 305,809 | |
Prepayments and other receivables | |
| 186,522 | |
Security rental deposits | |
| 47,290 | |
Property, plant and equipment | |
| 18,987 | |
Right of use assets | |
| 231,272 | |
Total Assets held for sale | |
| 789,880 | |
Liabilities directly associated with assets
classified as held for sale:
| |
March 31,
2024 | |
Current lease liabilities | |
| 242,416 | |
Payables and accruals | |
| 366,485 | |
Deferred income | |
| 285,809 | |
Retirement benefits obligations | |
| 433,508 | |
Total Liabilities held for sale | |
| 1,328,218 | |
Addex Therapeutics │ Unaudited Interim
Condensed Consolidated Financial Statements │Notes
Cash flows of discontinued operations:
| |
For
the three months Ended
March 31, | |
| |
2024 | | |
2023 | |
Net loss from discontinued operations | |
| (1,923,650 | ) | |
| (2,037,160 | ) |
Adjustments for: | |
| | | |
| | |
Depreciation | |
| 67,422 | | |
| 72,841 | |
Value of share-based services | |
| 327,682 | | |
| 366,523 | |
Post-employment benefits | |
| (27,338 | ) | |
| (29,480 | ) |
Finance cost net | |
| 5,672 | | |
| 5,311 | |
Decrease in other receivables | |
| 2,622 | | |
| 126,272 | |
Increase in prepayments | |
| (593,142 | ) | |
| (514,373 | ) |
Increase in payables and accruals | |
| 496,472 | | |
| 56,614 | |
Decrease in deferred income | |
| (38,401 | ) | |
| - | |
Net cash flow used in operating
activities | |
| (1,682,661 | ) | |
| (1,953,452 | ) |
| |
| | | |
| | |
Net cash flow used in investing activities | |
| | | |
| | |
Purchase of property, plant and equipment | |
| - | | |
| (2,469 | ) |
Net cash used in investing activities | |
| - | | |
| (2,469 | ) |
| |
| | | |
| | |
Cash flows used in financing activities | |
| | | |
| | |
Principal element of lease payment | |
| (63,770 | ) | |
| (111,196 | ) |
Interest paid | |
| (5,672 | ) | |
| (5,311 | ) |
Net cash used in financing activities | |
| (69,442 | ) | |
| (116,507 | ) |
| |
| | | |
| | |
Net cash used in discontinued
activities | |
| (1,752,103 | ) | |
| (2,072,428 | ) |
21. 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
March 31, | |
| |
2024 | | |
2023 | |
Net loss from continuing operations | |
| (735,178 | ) | |
| (370,009 | ) |
Net loss from discontinued operations | |
| (2,351,961 | ) | |
| (2,037,160 | ) |
Net loss attributable to equity
holders of the company | |
| (3,087,139 | ) | |
| (2,407,169 | ) |
Weighted average number of shares in issue | |
| 97,534,676 | | |
| 61,249,364 | |
Basic and diluted loss per share | |
| (0.03 | ) | |
| (0.04 | ) |
From continuing operations | |
| (0.01 | ) | |
| (0.01 | ) |
From discontinued operations | |
| (0.02 | ) | |
| (0.03 | ) |
The Company has three categories of dilutive
potential shares: treasury shares, share options and warrants which have been ignored in the calculation of the loss per share for the
three-month periods ended March 31, 2024 and 2023, as they would be antidilutive.
22. 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
March 31, | | |
For
the three months Ended
March 31, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| Continuing
operations | | |
| Discontinued
operations | |
Salaries, other short-term employee benefits and
post-employment benefits | |
| 59,828 | | |
| 34,567 | | |
| 319,348 | | |
| 313,123 | |
Consulting fees | |
| - | | |
| 4,350 | | |
| - | | |
| - | |
Share-based compensation | |
| 52,398 | | |
| 56,329 | | |
| 260,887 | | |
| 306,349 | |
Total | |
| 112,226 | | |
| 95,246 | | |
| 580,235 | | |
| 619,472 | |
Addex Therapeutics │ Unaudited Interim
Condensed Consolidated Financial Statements │Notes
The total compensation costs to key management
remain stable at CHF 0.7 million for the three-month period ended March 31, 2024 and including CHF 0.1 million recognized as continuing
operations and CHF 0.6 million recognized as discontinued operations.
The Group has a net payable to the Board of Directors
and Executive Management of CHF 0.1 million as of March 31, 2024 and December 31, 2023. Share-based compensation relates to
the fair value of equity incentive units recognized through profit and loss following their vesting plan.
23. Events after the balance sheet date
On April 2, 2024, the Group divested its
allosteric modulator drug discovery technology platform and a portfolio of preclinical programs to a newly formed Swiss company, Neurosterix
Pharma Sàrl (Neurosterix). Neurosterix has received committed funding of USD 63 million from a syndicate of investors led by Perceptive
Advisors (Perceptive Xontogeny Venture Fund II L.P, Perceptive Life Sciences Master Fund Ltd and Acorn Bioventures 2, L.P) (the “Neurosterix
Transaction” or “Transaction”). As part of the Transaction, Addex received gross proceeds of CHF 5.0 million in cash
and an equity interest representing 20% of Neurosterix. Addex retained its partnerships with Janssen Pharmaceuticals, Inc. and Indivior
PLC, as well as unpartnered clinical stage assets including dipraglurant for Parkinson’s disease and post-stroke/TBI recovery and
its preclinical GABAB PAM program for chronic cough. The Transaction includes the transfer of the associated R&D staff and infrastructure.
As part of the Transaction, Addex and Neurosterix entered into a service agreement which provides Addex with access to certain staff
and infrastructure to ensure the operation of the Addex retained business.
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 of a portfolio of novel orally available small molecule drug candidates.
Our business comprises of a pipeline of proprietary clinical and preclinical stage drug candidates that are being developed by our partners
and internally. 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, Parkinson’s disease levodopa induced
dyskinesia or PD-LID, post-stroke sensorimotor recovery, traumatic brain injury, or TBI, recovery, substance use disorder, or, SUD, and
cough.
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. We believe that the allosteric modulator principle
has broad applicability across a wide range of biological targets and therapeutic areas.
Our lead
partnered drug candidate, ADX71149 is a novel orally active metabotropic glutamate receptor subtype 2 positive allosteric modulator,
or mGlu2 PAM for the treatment of epilepsy. On April 29, 2024, we reported top-line data from a Phase 2 epilepsy study evaluating
adjunctive ADX71149 (JNJ-40411813) administration in patients with focal onset seizures with suboptimal response to levetiracetam or
brivaracetam. The Phase 2 study did not achieve statistical significance for the primary endpoint of time for patients to reach baseline
seizure count when ADX71149 was added to standard of care. Under our agreement with Janssen, Janssen is responsible for financing the
development and commercialization, if any, of ADX71149. We are currently working with our partner to evaluate next steps for the program.
Our lead
wholly owned drug candidate, dipraglurant, a metabotropic glutamate receptor subtype 5 negative allosteric modulator, or mGlu5 NAM, is
currently under evaluation for future development in PD-LID or post-stroke/TBI recovery. We have initiated discussions with potential
partners with the objective of collaborating with them for the future development of dipraglurant.
We are completing a funded
research program to discover novel gamma-aminobutyric acid subtype-b positive allosteric modulators, or GABAB PAMs, for Indivior PLC,
or Indivior. Under the terms of the agreement with Indivior, we have the right to select GABAB PAM drug candidates for a number of reserved
indications, including chronic cough. This target is clinically validated with baclofen, an orthosteric agonist of GABAB, used off label
to treat 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 significant
commercial opportunity. We are in the late clinical candidate selection phase and have demonstrated proof-of-concept in animal models
of cough with several GABAB PAM compounds. We expect to select drug candidates under the agreement with Indivior at the end of Q2 2024
and subject to securing financial resources expect to start IND enabling studies.
We cannot forecast with any
degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole
or in part, and how such arrangements would affect our development plan or capital requirements. To date, we have secured grants and
other funding from: The Michael J. Fox Foundation for Parkinson’s Research, or MJFF, for the development of dipraglurant for the
treatment of PD-LID; the National Institute of Drug Abuse, or NIDA, to generate important data on the role of GABAB in substance use
disorder and the Charcot-Marie-Tooth Association, or CMTA to evaluate the role of GABAB PAM compounds in preclinical models of CMT1A.
As we advance our clinical and preclinical programs, we will continue to apply for subsidies, grants and government or agency sponsored
studies that could offset or reduce our development costs.
The development and commercialization
of drugs is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized pharmaceutical companies,
including products approved for marketing and/or drug candidates under development, for each of the drug candidates and each of the indications
for which we are developing. Furthermore, government authorities in the United States, at the federal, state and local levels, and in
other countries, extensively regulate, among other things, the research, development, testing, manufacture, packaging, storage, recordkeeping,
labeling, advertising, promotion, distribution, marketing, import and export of pharmaceutical products, such as those we are developing.
The processes for obtaining regulatory approvals in the United States and in foreign countries, along with subsequent compliance with
applicable statutes and regulations, require the expenditure of substantial time and financial resources.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
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. On October 6,
2023, we filed a post-effective amendment to the form F-6 in order to change our ADS ratio from one ADS to six shares to a new ratio
of one ADS to one hundred and twenty shares. The ADS ratio change has been effective since October 23, 2023 and had the same effect
as a one to twenty ADS reverse split. The ADS ratio change had no impact on the Company’s underlying
shares and was intended to enable the Company to regain compliance with the Nasdaq minimum bid price requirement
of ADSs. On November 8, 2023, the company announced that it had received a written notification from Nasdaq confirming that
the compliance had been regained. In future, we may be subject to further written notifications from Nasdaq
related to the non-respect of continued listing rules such as minimum shareholders’ equity.
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 March 31, 2024,
we have generated CHF 66.6 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 March 31, 2024, we
have raised an aggregate of CHF 355.4 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 3.1 million and CHF 2.4 million
for the three-month periods ended March 31, 2024 and March 31, 2023, respectively. As of March 31, 2024, we had accumulated
losses of CHF 363.5 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 our portfolio of preclinical and clinical stage programs; |
| · | 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 drug 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.
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.
The Neurosterix Transaction
On
April 2, 2024, we divested our allosteric modulator discovery platform and a portfolio of pre-clinical programs to a new Swiss company,
Neurosterix Pharma Sàrl (equivalent to an LLC). Neurosterix is focused on the discovery and development of novel orally available
allosteric modulator drug candidates, including M4 PAM for schizophrenia, mGlu7NAM for stress related disorders and mGlu2NAM for mild
neurocognitive disorders. In connection with the Transaction, we received CHF 5.0 million and a 20% equity interest in Neurosterix US
Holdings LLC, the sole shareholder of Neurosterix. Neurosterix received USD 63 million in funding commitments from a syndicate of investors
led by Perceptive Advisors.
The
divestment of our discovery platform and early-stage programs includes the transfer of the associated research and development staff,
with a service agreement to allow key members of staff to support us in achieving our business strategy. As of the date of the Transaction,
all employees of the Group, other than our Head of Finance, became employees of Neurosterix. Pursuant to the service agreement, certain
former employees, including our Chief Executive Officer, will dedicate a portion of their time to the Group.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
License Agreement with Indivior
On January 2, 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, we
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, we are eligible for payments on successful
achievement of pre-specified clinical, regulatory and commercial milestones totaling USD 330 million, and royalties on net sales
ranging from 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 and duration of two years with a funding of USD 4.0 million over the period for the Addex R&D costs incurred, that can
be extended by twelve-month increments. R&D costs are calculated based on the costs incurred in accordance with the contract. 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 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 an 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 was 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 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
agreement with Indivior has been extended until June 30, 2024 and Indivior committed to additional research funding of CHF 2.7 million
including CHF 1.1 million expected to be paid to 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 completed a Phase 2a
proof of concept clinical trial of ADX71149 in epilepsy patients in April 2024. 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 March 31, 2024, we recognized CHF 18.6 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 March 2024, 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 other discovery activities.
In July 2019, we were
funded by Eurostars/Innosuisse for CHF 0.5 million to support the mGlu7 NAM program totally recognized as income as of December 31,
2021.
In
September 2023, we were funded by Eurostars/Innosuisse for CHF 0.5 million to support the mGlu2 NAM program of which CHF 0.3 million
were received in December 2023. As of April 2, 2024, following the Neurosterix Transaction, other income recognized through
this grant in the first quarter of 2024 has been reclassed in the financial line of the statements of comprehensive loss called “net
loss from discontinued operations”. The remaining funds and the associated deferred income have been reclassed as assets
and liabilities held for sale respectively as of March 31, 2024.
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.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Operating Expenses
Research and Development Costs
From
the beginning of January 2017 through March 2024, we incurred CHF 66.4 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. Following the sale of the allosteric modulator discovery platform and the portfolio of preclinical programs,
including our M4 PAM program to Neurosterix on April 2, 2024, Research and development costs displayed further don’t include
any personnel and share based compensation costs in the first quarter of 2024 and 2023 respectively, in accordance to IFRS principles
as all R&D employees have been transferred to Neurosterix. Associated costs for this period have been recognized in the financial
line of the statements of comprehensive loss called “net loss from discontinued operations”.
We typically use our 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 from continuing operations that are directly attributable to the specified
programs for the three-month period ended March 31, 2024 and 2023:
|
|
For the three
months
Ended March 31, |
|
|
|
2024 |
|
|
2023* |
|
Dipraglurant PD-LID |
|
|
52 |
|
|
|
29 |
|
GABAB PAM |
|
|
127 |
|
|
|
171 |
|
Total outsourced research and development
costs – continuing operations |
|
|
179 |
|
|
|
200 |
|
*The 2023 comparative has been re-presented in order to disclose
only continuing operations following the Neurosterix transaction described above. For more information, please refer to the paragraph
below related to the analysis of results of operations.
Our
research and development expenses are low due to the Neurosterix Transaction. The table above does not reflect outsourced research and
development costs related to the allosteric modulator discovery platform and the portfolio of preclinical programs, including our M4
PAM program, sold to Neurosterix and considered as discontinued operations in accordance with IFRS principles for the first quarter of
2024 and 2023 respectively. Discontinued operation costs have been reclassed in the financial line of the statements of comprehensive
loss called “net loss from discontinued operations”. We have no ongoing self-funded clinical studies. In the medium and long
term, our expenses may increase, particularly as we continue to the development of a GABAB PAM drug candidate, initiate further clinical
trials and seek marketing approval for our drug candidates.
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 drug 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.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
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 and
fees for accounting and financial or tax consulting services.
Our
general and administrative costs are low due to Neurosterix Transaction. General and administrative costs indicated in this section are
related to continuing operations. General and administrative costs related to discontinued operations have been reclassed in the
financial line of the statements of comprehensive loss called “net loss from discontinued operations”.
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.
Net loss from discontinued operations
Net
loss from discontinued operations relate to other income, research and development costs, general and administrative costs and finance
result incurred by the allosteric modulator drug discovery technology platform and a portfolio of preclinical programs sold to Neurosterix
on April 2, 2024. The net loss from discontinued operations has been reclassed in the statements of comprehensive loss under
“net loss from discontinued operations”.
Analysis of Results of Operations
The following table presents
our consolidated results of operations for the three-month periods ended March 31, 2024 and 2023:
| |
For the three months
ended March 31, | |
| |
2024 | | |
2023* | |
Revenue | |
| 234 | | |
| 501 | |
Other income | |
| 1 | | |
| 1 | |
Research and development costs | |
| (245 | ) | |
| (255 | ) |
General and administrative costs | |
| (778 | ) | |
| (615 | ) |
Operating loss from continuing operations | |
| (788 | ) | |
| (368 | ) |
Finance income | |
| 54 | | |
| 24 | |
Finance expense | |
| (1 | ) | |
| (26 | ) |
Net loss from continuing operations | |
| (735 | ) | |
| (370 | ) |
Net loss from discontinued operations
(attributable to equity holders of the Group) | |
| (2,352 | ) | |
| (2,037 | ) |
Net loss for the period | |
| (3,087 | ) | |
| (2,407 | ) |
*
The comparative information has been re-presented due to discontinued operations that have been reclassed to the financial
line called “Net loss from discontinued operations”, following the Neurosterix transaction described above. In the financial
analysis related to the results of operations made further in the section an asterisk will remind when comparative information has been
re-presented.
Three Months Ended March 31, 2024
Compared to Three Months Ended March 31, 2023
Revenue
The following table sets
forth our revenue in the three-month periods ended March 31, 2024 and 2023:
| |
For the three months
ended March 31, | |
| |
2024 | | |
2023* | |
| |
| | |
| |
| |
(CHF in thousands) | |
Collaborative research funding | |
| 234 | | |
| 501 | |
Total | |
| 234 | | |
| 501 | |
Revenue decreased by CHF
0.3 million in the three-month period ended March 31, 2024 compared to the three-month period ended March 31, 2023 due to amounts
received under our agreement with Indivior which are recognized as related costs are incurred.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Other Income
The following table sets
forth our other income in the three-month periods ended March 31, 2024 and 2023:
| |
For the three months
ended
March 31, | |
| |
2024 | | |
2023* | |
| |
| | |
| |
| |
(CHF in thousands) | |
Other service income | |
| 1 | | |
| 1 | |
Total | |
| 1 | | |
| 1 | |
Other income primarily relates
to IT consulting services. Other income related to Eurostars/Innosuisse grant for mGlu2 NAM has been recognized under “loss from
discontinued operations” for the first quarter 2024.
Research and Development Expenses
The following table sets
forth our research and development expenses in the three-month periods ended March 31, 2024 and 2023:
| |
For the three months
ended
March 31, | |
| |
2024 | | |
2023* | |
| |
| | |
| |
| |
(CHF in thousands) | |
Dipraglurant PD-LID | |
| 52 | | |
| 29 | |
GABAB PAM | |
| 127 | | |
| 171 | |
Subtotal
outsourced R&D per program | |
| 179 | | |
| 200 | |
Patent maintenance and registration costs | |
| 55 | | |
| 58 | |
Other operating costs | |
| 11 | | |
| (3 | ) |
Subtotal
unallocated R&D expenses | |
| 66 | | |
| 55 | |
Total | |
| 245 | | |
| 255 | |
Research and development
expenses remain stable at CHF 0.3 million for the first quarter of 2024 and 2023 respectively. Research and development costs described
in the table above for the first quarter of 2024 and 2023, respectively, relate to continuing activities that have not been sold to Neurosterix.
Discontinued operations relate to the allosteric modulator discovery platform and a portfolio of preclinical programs, including our
M4 PAM program, sold to Neurosterix. Costs attributed to discontinued operations are included in the statements of comprehensive loss
under “net loss from discontinued operations” for the first quarter 2024 and 2023, respectively.
General and Administrative Costs
The following table sets
forth our general and administrative costs in the three-month periods ended March 31, 2024 and 2023:
|
|
For the three
months ended
March 31, |
|
|
|
2024 |
|
|
2023* |
|
|
|
|
|
|
|
|
|
|
(CHF in thousands) |
|
Staff costs |
|
|
69 |
|
|
|
55 |
|
Depreciation and amortization |
|
|
3 |
|
|
|
3 |
|
Professional fees |
|
|
452 |
|
|
|
294 |
|
D&O Insurance |
|
|
51 |
|
|
|
156 |
|
Other operating costs |
|
|
203 |
|
|
|
107 |
|
Total |
|
|
778 |
|
|
|
615 |
|
General and administrative costs increased by
CHF 0.2 million in the three-month period ended March 31, 2024, compared to the three-month period ended March 31, 2023, primarily
due to increased legal fees. General and administrative costs displayed in the table above relate to the costs attributed to continuing
operations in the first quarter of 2024 and 2023, respectively. Costs attributed to discontinued operations are included in the statement
of comprehensive loss under “net loss from discontinued operations” for the first quarter of 2024 and 2023, respectively.
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 March 31, 2024 and 2023:
| |
For the three months
ended
March 31, | |
| |
2024 | | |
2023* | |
| |
| | |
| |
| |
(CHF in thousands) | |
Interest income | |
| 8 | | |
| 24 | |
Interest expense on leases | |
| (1 | ) | |
| (1 | ) |
Foreign exchange gain / (loss), net | |
| 46 | | |
| (25 | ) |
Total | |
| 53 | | |
| (2 | ) |
Finance result, net increased
by CHF 0.1 million during the three-month period ended March 31, 2024 compared to the three-month period ended March 31, 2023,
primarily due to the impact of a strengthening U.S dollar on U.S dollar cash deposits.
Capital Resources
Since
our inception through March 31, 2024, we have generated CHF 66.6 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 March 31,
2024, we raised an aggregate of CHF 355.4 million of gross proceeds from the sale of equity. As at March 31, 2024, we had CHF 1.6
million in cash and cash equivalents. Between the closing date and the issuance date of these unaudited condensed consolidated financial
statements, we have raised gross proceeds of CHF 5.0 million from the sale of our allosteric modulator drug discovery technology platform
and a portfolio of preclinical programs to Neurosterix. We also received a 20% equity interest in Neurosterix US Holdings LLC,
the sole shareholder of Neurosterix.
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.
In the medium and long term,
we expect an increase of our expenses compared to the three-month period ended March 31, 2024, as we continue to the development
of our GABAB PAM chronic cough drug candidate, 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 condensed consolidated financial statements will enable us to fund our operating
expenses and capital expenditure requirements through 2026. 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 study for our GABAB
PAM cough indication drug candidate; |
| · | 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; |
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
| · | cost
associated with finding alternative suppliers due to geopolitical events such as the ongoing
war in Ukraine; |
| · | the
costs associated with building out our operations; and |
| · | 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 of the continuing operations for the periods indicated:
| |
For the three months
ended March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
| |
(CHF in thousands) | |
Net cash flows used in continuing operating activities | |
| (512 | ) | |
| (406 | ) |
Net cash flows (used in) / from continuing investing activities | |
| - | | |
| - | |
Net cash flows from continuing financing
activities | |
| 234 | | |
| 1,145 | |
Net cash (used) / from in continuing
operating activities | |
| (278 | ) | |
| 739 | |
Operating activities of continuing operations
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 of right-of-use
assets, the value of share-based services, changes in post-employment benefits and finance costs.
During the three-month period
ended March 31, 2024, continuing operating activities used CHF 0.5 million of cash primarily due to our net loss of CHF 0.7 million
partially offset for CHF 0.2 million of increased net working capital mainly due to decreased trade payables and accruals.
During the three-month period
ended March 31, 2023, operating activities used CHF 0.4 million of cash primarily due to our net loss of CHF 0.4 million adjusted
for CHF 0.1 million of increased net working capital offset by non-cash items for CHF 0.1 million mainly related to share-based services.
The increase of the net working capital is mainly due to increased prepayments related to retirement benefits paid annually at the beginning
of the year.
Investing activities of continuing operations
Net cash used in continuing
investing activities is nil for the three-month periods ended March 31, 2024 and 2023.
MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Financing activities of continuing operations
Cash flows from financing
activities, related to continuing continued operations, primarily consists of proceeds from the sale of equity securities.
During the three-month period
ended March 31, 2024, net cash flows from financing activities amount to CHF 0.2 million and primarily relate to the net proceeds
from the sale of treasury shares through our sale agency agreement with Kepler Cheuvreux.
During the three-month period
ended March 31, 2023, net cash flows from financing activities amounted to CHF 1.1 million and primarily relate to the gross proceeds
from the sale of treasury shares under our sale agency agreement with Kepler Cheuvreux.
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, 2024 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 USD 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 USD 700 million as of the prior June 30, and (2) the date
on which we have issued more than USD 1.0 billion in non-convertible debt during the prior three-year period.
Exhibit 99.3
PRESS
RELEASE |
|
![](https://www.sec.gov/Archives/edgar/data/1574232/000110465924068801/tm2416528d1_ex99-3img001.jpg) |
Addex Therapeutics
Reports Q1 2024 Financial Results and Provides Corporate Update
| ● | GABAB PAM: Selection of drug
candidates under Indivior collaboration expected by end of Q2 2024. |
Ad Hoc Announcement Pursuant to Art.
53 LR
Geneva, Switzerland,
June 6, 2024 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing
a portfolio of novel small molecule allosteric modulators for neurological disorders, today reported its Q1 2024 financial results and
provided a corporate update.
“Building
on the recent Neurosterix transaction, which extended our cash runway beyond 2026 and will accelerate the development of a portfolio
of preclinical programs, we anticipate selection of drug candidates under the agreement with Indivior by the end of the second quarter
of 2024,” said Tim Dyer CEO of Addex. “During the rest of 2024, we will focus on advancing our GABAB PAM drug candidate for
chronic cough and dipraglurant for brain injury recovery as well as working with our partner, Janssen Pharmaceuticals Inc., to evaluate
the future development of ADX71149.”
Operating Highlights:
| · | Selection
of drug candidates under the GABAB PAM collaboration with Indivior expected by the end of
the second quarter of 2024; |
| · | Launched
Neurosterix with Perceptive Advisors, raising USD 63 million in Series A to accelerate
the development of a preclinical portfolio including M4 PAM for schizophrenia; |
| · | Received
CHF 5 million and 20% equity in Neurosterix in April 2024 and secured cash runway beyond
2026; and |
| · | Our
partner, Janssen Pharmaceuticals Inc., completed ADX71149 epilepsy Phase 2 study; top-line
results did not show statistical significance. |
Key Q1 2024 Financial Data
CHF’ thousands | |
Q1 2024 | | |
Q1 2023 * | | |
Change | |
Income | |
| 235 | | |
| 502 | | |
| (267 | ) |
R&D expenses | |
| (245 | ) | |
| (255 | ) | |
| 10 | |
G&A expenses | |
| (778 | ) | |
| (615 | ) | |
| (163 | ) |
Total operating loss | |
| (788 | ) | |
| (368 | ) | |
| (420 | ) |
Finance result, net | |
| 53 | | |
| (2 | ) | |
| 55 | |
Net loss from continuing operations | |
| (735 | ) | |
| (370 | ) | |
| (365 | ) |
Net loss from discontinued operations | |
| (2,352 | ) | |
| (2,037 | ) | |
| (315 | ) |
Net loss for the period | |
| (3,087 | ) | |
| (2,407 | ) | |
| (680 | ) |
Basic and diluted net loss per share: | |
| | | |
| | | |
| | |
From continuing operations | |
| (0.01 | ) | |
| (0.01 | ) | |
| 0.00 | |
From discontinued operations | |
| (0.02 | ) | |
| (0.03 | ) | |
| 0.01 | |
Total basic and diluted net loss per share | |
| (0.03 | ) | |
| (0.04 | ) | |
| 0.01 | |
Net decrease in cash and cash equivalents | |
| (2,237 | ) | |
| (1,362 | ) | |
| (875 | ) |
Cash and cash equivalents | |
| 1,628 | | |
| 5,595 | | |
| (3,967 | ) |
Shareholders’ equity | |
| (1,373 | ) | |
| 4,071 | | |
| (5,444 | ) |
* The
comparative information has been re-presented due to discontinued operations that have been reclassed to the financial line called “Net
loss from discontinued operations” following Neurosterix transaction.
Financial Summary:
Under IFRS, the
sale of our allosteric modulator drug discovery platform and unpartnered preclinical portfolio to Neurosterix on April 2, 2024,
required the identification of continuing operations related to retained programs by Addex and discontinued operations for the three-month
period ended March 31, 2024 and 2023. The income and expenses from discontinued operations have been reclassed to the financial
line called “Net loss from discontinued operations”. All financial variance described below relate to continuing operations.
Income decreased
by CHF 0.3 million to CHF 0.2 million in the first quarter 2024 compared to CHF 0.5 million in the first quarter 2023, primarily driven
by amounts received under our funded research collaboration with Indivior, recognized as related costs are incurred.
R&D expenses
primarily relate to our GABAB PAM program and remain stable at CHF 0.3 million for both first quarters of 2024 and 2023.
G&A expenses
increased by CHF 0.2 million to CHF 0.8 million in the first quarter 2024 compared to CHF 0.6 million in the first quarter 2023, primarily
due to legal fees.
The net loss from
continuing operations increased by CHF 0.4 million primarily due to reduced income and increased G&A.
Basic and diluted
loss per share from continuing operations remain stable at CHF 0.01 for the first quarter 2024 compared to the first quarter 2023.
Cash and cash equivalents
decreased to CHF 1.6 million at March 31, 2024, compared to CHF 5.6 million at March 31, 2023. The decrease of CHF 5.4 million
between March 31, 2024 and March 31, 2023 is primarily due to the cash used in operating activities, partially offset by funds
raised from one single institutional investor in April 2023. Gross proceeds of CHF 5.0 million from Neurosterix’s transaction
was received in April 2024.
Q1 2024 Consolidated
Financial Statements:
The Q1 2024 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, June 6, 2024, at 16:00 CEST (15:00 BST / 10:00 EDT / 07:00 PDT) to review the financial results. Tim Dyer,
Chief Executive Officer and Misha 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. |
Webcast registration URL:
https://edge.media-server.com/mmc/p/5twaqd3r
Conference call registration URL:
https://register.vevent.com/register/BI042149b2b22741eb96c2d718ff2853bb
About Addex:
Addex Therapeutics is a
clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological
disorders. Addex’s lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with
Janssen Pharmaceuticals Inc., has recently completed a Phase 2 clinical study for the treatment of epilepsy. The Company’s second
clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in dyskinesia
associated with Parkinson’s disease and post-stroke/TBI recovery. Addex partnership with Indivior on GABAB PAM is advancing multiple
drug candidates through clinical candidate selection for substance use disorder. Under the agreement with Indivior, Addex is advancing
an independent GABAB PAM program for chronic cough through clinical candidate selection. Addex also holds a 20% share in a private company,
Neurosterix LLC which is advancing a portfolio of allosteric modulator programs including M4PAM for schizophrenia, mGlu7NAM for stress
related disorders and mGlu2NAM for mild neurocognitive disorders. 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. For more information, visit www.addextherapeutics.com
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, 2023, as filed with the SEC on April 18, 2024, 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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