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

 

November 2021

 

 

 

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) 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such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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 set forth in our Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 11, 2021. 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.

 

2

 

 

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: November 4, 2021   Title: Chief Executive Officer

 

3

 

 

EXHIBIT INDEX

 

Exhibit
No.
  Description
Exhibit 99.1 :   Unaudited Condensed Consolidated Financial Statements
Exhibit 99.2 :   Management's Discussion and Analysis of Financial Condition and Results of Operations
Exhibit 99.3 :   Press Release dated November 4, 2021

 

4

 

 

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 September 30, 2021 and December 31, 2020 2
Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss for the three-month and nine-month periods ended September 30, 2021 and 2020 3
Unaudited Interim Condensed Consolidated Statements of Changes in Equity for the nine-month periods ended September 30, 2021 and 2020 4
Unaudited Interim Condensed Consolidated Statements of Changes in Equity for the three-month periods ended September 30,2021 and 2020 5
Unaudited Interim Condensed Consolidated Statements of Cash Flows for the nine-month periods ended September 30, 2021 and 2020 7
Unaudited Notes to the Interim Condensed Consolidated Financial Statements for the three-month and nine-month periods ended September 30, 2021 8

 

 

 

Addex Therapeutics │ Interim Condensed Consolidated Financial Statements

 

Unaudited Interim Condensed Consolidated Balance Sheets

 

as of September 30, 2021, and December 31, 2020

 

    Notes     September 30,
2021
    December 31,
2020
 
                    
          Amounts in Swiss francs    
ASSETS                    
                     
Current assets                    
Cash and cash equivalents   6     15,486,114       18,695,040  
Other financial assets   7/15     27,963       64,930  
Trade and other receivables   7     199,035       68,373  
Contract asset   7     383,432       -  
Prepayments and deferred costs   7     1,339,521       661,221  
Total current assets         17,436,065       19,489,564  
                     
Non-current assets                    
Right-of-use assets   8     511,805       565,344  
Property, plant and equipment   9     54,206       67,760  
Non-current financial assets   10     57,995       59,144  
Total non-current assets         624,006       692,248  
                     
Total assets         18,060,071       20,181,812  
                     
LIABILITIES AND EQUITY                    
                     
Current liabilities                    
Current lease liabilities         290,990       308,611  
Payables and accruals   11     2,980,274       2,491,927  
Contract liability   15     -       733,668  
Deferred income   16     -       86,481  
Total current liabilities         3,271,264       3,620,687  
                     
Non-current liabilities                    
Non-current lease liabilities         230,234       258,785  
Retirement benefits obligations   14     1,217,605       1,692,537  
Total non-current liabilities         1,447,839       1,951,322  
                     
Equity                    
Share capital   12     49,272,952       32,848,635  
Share premium   12     288,278,928       286,888,354  
Treasury shares reserve   12     (15,475,255 )     (6,078,935 )
Other reserves         15,898,186       14,657,637  
Accumulated deficit         (324,633,843 )     (313,705,888 )
Total equity         13,340,968       14,609,803  
                     
Total liabilities and equity         18,060,071       20,181,812  

 

The accompanying notes form an integral part of these consolidated financial statements.

 

2

 

 

Addex Therapeutics │ Interim Condensed Consolidated Financial Statements 3

 

Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss

 

for the three-month and nine-month periods ended September 30, 2021 and 2020

 

        For the three months ended
September 30,  
    For the nine months ended
September 30,  
 
    Notes   2021       2020       2021       2020    
                             
         Amounts in Swiss francs  
Revenue from contract with customer     15     682,002       27,264       2,518,820       1,792,117  
Other income     16     75,778       75,388       233,261       195,345  
                                       
Operating costs                                      
Research and development           (2,862,276 )     (1,978,955 )     (9,342,158 )     (7,850,543 )
General and administration           (1,471,335 )     (1,236,729 )     (4,640,419 )     (4,496,535 )
Total operating costs     17     (4,333,611 )     (3,215,684 )     (13,982,577 )     (12,347,078 )
                                       
Operating loss           (3,575,831 )     (3,113,032 )     (11,230,496 )     (10,359,616 )
                                       
Finance income           (12,373 )     1,280       356,209       34,049  
Finance expense           (9,989 )     (201,282 )     (53,668 )     (408,126 )
Finance result     19     (22,362 )     (200,002 )     302,541       (374,077 )
                                       
Net loss before tax           (3,598,193 )     (3,313,034 )     (10,927,955 )     (10,733,693 )
Income tax expense           -       -       -       -  
Net loss for the period           (3,598,193 )     (3,313,034 )     (10,927,955 )     (10,733,693 )
                                       
Basic and diluted loss per share for loss attributable to the ordinary equity holders of the Company     20     (0.11 )     (0.12 )     (0.32 )     (0.40 )
                                       
Other comprehensive income/(loss)                                      
Items that will never be reclassified to profit and loss:                                      
Remeasurements of retirement benefits obligation           84,544       (150,130 )     336,006       (192,178 )
Items that may be classified subsequently to profit and loss:                                      
Exchange difference on translation of foreign operations           (1,169 )     (1,278 )     527       (2,125 )
Other comprehensive income/(loss) for the period, net of tax           83,375       (151,408 )     336,533       (194,303 )
                                       
Total comprehensive loss for the period           (3,514,818 )     (3,464,442 )     (10,591,422 )     (10,927,996 )

 

The accompanying notes form an integral part of these consolidated financial statements.

 

3

 

 

 

Addex Therapeutics │ Interim Condensed Consolidated Financial Statements

 

Unaudited Interim Condensed Consolidated Statements of Changes in Equity

 

For the nine-month periods ended September 30, 2021 and 2020

 

    Notes     Share
Capital
    Share
Premium
    Treasury
Shares
Reserve
    Foreign
Currency
Translation
Reserve
    Additional
Reserves
    Accumulated
Deficit
    Total  
                                                 
          Amounts in Swiss francs  
Balance as of January 1, 2020             32,848,635       286,375,977       (6,572,316 )     (653,161 )     14,371,983       (300,847,289 )     25,523,829  
Net loss for the period             -       -       -       -       -       (10,733,693 )     (10,733,693 )
Other comprehensive loss for the period             -       -       -       (2,125 )     (192,178 )     -       (194,303 )
Total comprehensive loss for the period             -       -       -       (2,125 )     (192,178 )     (10,733,693 )     (10,927,996 )
Value of share-based services     13       -       -       -       -       946,234       -       946,234  
Movement in treasury shares:     12                                                          
Settlement of supplier invoices             -       58,442       171,079       -       -       -       229,521  
Net purchases under liquidity agreement             -       28,796       (56,418 )     -       -       -       (27,622 )
Balance as of September 30, 2020             32,848,635       286,463,215       (6,457,655 )     (655,286 )     15,126,039       (311,580,982 )     15,743,966  
                                                                 
Balance as of January 1, 2021             32,848,635       286,888,354       (6,078,935 )     (657,230 )     15,314,867       (313,705,888 )     14,609,803  
Net loss for the period             -       -       -       -       -       (10,927,955 )     (10,927,955 )
Other comprehensive income for the period             -       -       -       527       336,006       -       336,533  
Total comprehensive loss for the period             -       -       -       527       336,006       (10,927,955 )     (10,591,422 )
Issue of shares-third parties     12       6,900,000       3,199,323       -       -       -       -       10,099,323  
Issue of treasury shares     12       9,524,317       -       (9,524,317 )     -       -       -       -  
Cost of share capital issuance             -       (1,896,021 )     -       -       -       -       (1,896,021 )
Value of share-based services     13       -       -       -       -       904,016       -       904,016  
Movement in treasury shares:     12                                                          
Settlement of supplier invoices             -       48,517       112,026       -       -       -       160,543  
Net purchases under liquidity agreement             -       (5,799 )     (31,169 )     -       -       -       (36,968 )
Sales under ATM program             -       3,882       7,200       -       -       -       11,082  
Cost of treasury shares sales             -       (332 )     -       -       -       -       (332 )
Other net sales of treasury shares             -       41,004       39,940       -       -       -       80,944  
Balance as of September 30, 2021             49,272,952       288,278,928       (15,475,255 )     (656,703 )     16,554,889       (324,633,843 )     13,340,968  

 

The accompanying notes form an integral part of these consolidated financial statements.

 

4

 

 

Addex Therapeutics │ Interim Condensed Consolidated Financial Statements

 

Unaudited Interim Condensed Consolidated Statements of Changes in Equity

 

For the three-month period ended September 30, 2021 (1/2)

 

    Notes     Share
Capital
    Share
Premium
    Treasury
Shares
Reserve
    Foreign
Currency
Translation
Reserve
    Additional
Reserves
    Accumulated
Deficit
    Total  
                                                 
          Amounts in Swiss francs  
Balance as of January 1, 2020             32,848,635       286,375,977       (6,572,316 )     (653,161 )     14,371,983       (300,847,289 )     25,523,829  
Net loss for the period             -       -       -       -       -       (4,305,921 )     (4,305,921 )
Other comprehensive income for the period             -       -       -       (33 )     184,951       -       184,918  
Total comprehensive loss for the period             -       -       -       (33 )     184,951       (4,305,921 )     (4,121,003 )
Value of share-based services     13       -       -       -       -       297,708       -       297,708  
Movement in treasury shares:     12                                                          
Settlement of supplier invoices             -       20,123       62,808       -       -       -       82,931  
Net sales under liquidity agreement             -       (3,193 )     596       -       -       -       (2,597 )
Balance as of March 31, 2020             32,848,635       286,392,907       (6,508,912 )     (653,194 )     14,854,642       (305,153,210 )     21,780,868  
Net loss for the period             -       -       -       -       -       (3,114,738 )     (3,114,738 )
Other comprehensive loss for the period             -       -       -       (814 )     (226,999 )     -       (227,813 )
Total comprehensive loss for the period             -       -       -       (814 )     (226,999 )     (3,114,738 )     (3,342,551 )
Value of share-based services     13       -       -       -       -       343,083       -       343,083  
Movement in treasury shares:     12                                                          
Settlement of supplier invoices             -       7,832       49,034       -       -       -       56,866  
Net purchases under liquidity agreement             -       (4,794 )     (32,355 )     -       -       -       (37,149 )
Balance as of June 30, 2020             32,848,635       286,395,945       (6,492,233 )     (654,008 )     14,970,726       (308,267,948 )     18,801,117  
Net loss for the period             -       -       -       -       -       (3,313,034 )     (3,313,034 )
Other comprehensive loss for the period             -       -       -       (1,278 )     (150,130 )     -       (151,408 )
Total comprehensive loss for the period             -       -       -       (1,278 )     (150,130 )     (3,313,034 )     (3,464,442 )
Value of share-based services     13       -       -       -       -       305,443       -       305,443  
Movement in treasury shares:     12                                                          
Settlement of supplier invoices             -       30,487       59,237       -       -       -       89,724  
Net purchases under liquidity agreement             -       36,783       (24,659 )     -       -       -       12,124  
Balance as of September 30, 2020             32,848,635       286,463,215       (6,457,655 )     (655,286 )     15,126,039       (311,580,982 )     15,743,966  

 

The accompanying notes form an integral part of these consolidated financial statements.

 

5

 

 

Addex Therapeutics │ Interim Condensed Consolidated Financial Statements 

 

Unaudited Interim Condensed Consolidated Statements of Changes in Equity

 

For the three-month period ended September 30, 2021 (2/2)

 

    Notes     Share
Capital
    Share
Premium
    Treasury
Shares
Reserve
    Foreign
Currency
Translation
Reserve
    Additional
Reserves
    Accumulated
Deficit
    Total  
                                                 
          Amounts in Swiss francs  
Balance as of January 1, 2021             32,848,635       286,888,354       (6,078,935 )     (657,230 )     15,314,867       (313,705,888 )     14,609,803  
Net loss for the period             -       -       -       -       -       (2,639,613 )     (2,639,613 )
Other comprehensive income for the period             -       -       -       464       125,401       -       125,865  
Total comprehensive loss for the period             -       -       -       464       125,401       (2,639,613 )     (2,513,748 )
Issue of shares-third parties     12       6,900,000       3,199,323       -       -       -       -       10,099,323  
Cost of share capital issuance             -       (1,767,053 )     -       -       -       -       (1,767,053 )
Value of share-based services     13       -       -       -       -       186,102       -       186,102  
Movement in treasury shares:     12                                                          
Settlement of supplier invoices             -       21,284       37,382       -       -       -       58,666  
Net purchases under liquidity agreement             -       8,061       (63,028 )     -       -       -       (54,967 )
Other net sales of treasury shares             -       41,004       39,940       -       -       -       80,944  
Balance as of March 31, 2021             39,748,635       288,390,973       (6,064,641 )     (656,766 )     15,626,370       (316,345,501 )     20,699,070  
Net loss for the period             -       -       -       -       -       (4,690,149 )     (4,690,149 )
Other comprehensive income for the period             -       -       -       1,232       126,061       -       127,293  
Total comprehensive loss for the period             -       -       -       1,232       126,061       (4,690,149 )     (4,562,856 )
Issue of treasury shares     12       9,524,317       -       (9,524,317 )     -       -       -       -  
Cost of share capital issuance             -       (135,434 )     -       -       -       -       (135,434 )
Value of share-based services     13       -       -       -       -       336,849       -       336,849  
Movement in treasury shares:     12                                                          
Settlement of supplier invoices             -       13,831       42,924       -       -       -       56,755  
Net sales under liquidity agreement             -       (12,483 )     40,825       -       -       -       28,342  
Balance as of June 30, 2021             49,272,952       288,256,887       (15,505,209 )     (655,534 )     16,089,280       (321,035,650 )     16,422,726  
Net loss for the period             -       -       -       -       -       (3,598,193 )     (3,598,193 )
Other comprehensive income for the period             -       -       -       (1,169 )     84,544       -       83,375  
Total comprehensive loss for the period             -       -       -       (1,169 )     84,544       (3,598,193 )     (3,514,818 )
Cost of share capital issuance             -       6,466       -       -       -       -       6,466  
Value of share-based services     13       -       -       -       -       381,065       -       381,065  
Movement in treasury shares:     12                                                          
Settlement of supplier invoices             -       13,402       31,720       -       -       -       45,122  
Net purchases under liquidity agreement             -       (1,377 )     (8,966 )     -       -       -       (10,343 )
Sales under ATM program             -       3,882       7,200       -       -       -       11,082  
Cost of treasury shares sales             -       (332 )     -       -       -       -       (332 )
Balance as of September 30, 2021             49,272,952       288,278,928       (15,475,255 )     (656,703 )     16,554,889       (324,633,843 )     13,340,968  

 

The accompanying notes form an integral part of these consolidated financial statements.

 

6

 

 

 

Addex Therapeutics │ Interim Condensed Consolidated Financial Statements

 

Unaudited Interim Condensed Consolidated Statements of Cash Flows

 

for the nine-month periods ended September 30, 2021 and 2020

 

          For the nine months ended
September 30,
 
    Notes     2021     2020  
                   
              Amounts in Swiss francs  
Net loss for the period             (10,927,955 )     (10,733,693 )
Adjustments for:                        
Depreciation     8 /9     264,647       291,677  
Disposal of right-of-use assets             (127 )     -  
Value of share-based services     13       904,016       946,234  
Post-employment benefits             (138,926 )     (42,031 )
Finance cost/(income) net             (328,768 )     412,504  
Decrease/(increase) in other financial assets     7       36,967       (52,378 )
Decrease/(increase) in trade and other receivables     7       (130,662 )     42,192  
Increase in contract asset     7       (383,432 )     -  
Increase in prepayments     7       (841,139 )     (572,751 )
Increase/(decrease) in payables and accruals     11       444,687       (2,279,614 )
Decrease in contract liability     15       (733,668 )     (945,737 )
Decrease in deferred income     16       (86,481 )     (180,839 )
Services paid in shares             160,543       229,521  
Net cash used in operating activities             (11,760,298 )     (12,884,915 )
                         
Cash flows from investing activities                        
Purchase of property, plant and equipment     9       (7,063 )     (11,329 )
Proceeds from decrease in non-current financial assets     10       1,149       -  
Net cash used in investing activities             (5,914 )     (11,329 )
                         
Cash flows from financing activities                        
Proceeds from capital increase             10,161,746       -  
Costs paid on issue of shares             (1,685,668 )     (109,167 )
(Purchase)/sale of treasury shares             54,726       (27,622 )
Principal element of lease payment             (235,715 )     (281,314 )
Interest received     19       4,568       34,049  
Interest paid     19       (53,668 )     (59,228 )
Net cash from/(used in) financing activities             8,245,989       (443,282 )
                         
Decrease in cash and cash equivalents             (3,520,223 )     (13,339,526 )
                         
Cash and cash equivalents at the beginning of the period     6       18,695,040       31,536,803  
Exchange difference on cash and cash equivalents             311,297       (383,827 )
                         
Cash and cash equivalents at the end of the period     6       15,486,114       17,813,450  

 

The accompanying notes form an integral part of these consolidated financial statements.

 

7

 

 

Unaudited Notes to the Interim Condensed Consolidated Financial Statements

 

for the three-month and nine-month periods ended September 30, 2021

 

(Amounts in Swiss francs)

 

1. General information

 

Addex Therapeutics Ltd (the “Company”), formerly Addex Pharmaceuticals Ltd, and its subsidiaries (together, the “Group”) are a clinical stage pharmaceutical group applying its leading allosteric modulator drug discovery platform to discovery and development of small molecule pharmaceutical products, with an initial focus on central nervous system disorders.

 

The Company is a Swiss stockholding corporation domiciled c/o Addex Pharma SA, Chemin des Aulx 12, CH1228 Plan-les-Ouates, Geneva, Switzerland and the parent company of Addex Pharma SA, Addex Pharmaceuticals France SAS and Addex Pharmaceuticals Inc. registered in Delaware with its principal business location in San Francisco, California, United States. 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 condensed consolidated financial statements have been approved for issuance by the Board of Directors on November 3, 2021.

 

2. Basis of preparation

 

These condensed consolidated interim financial statements for the three-month and nine-month periods ended September 30, 2021, 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, 2020.

 

Interim financial results are not necessarily indicative of results anticipated for the full year. The preparation of these unaudited condensed consolidated interim 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 condensed consolidated interim financial statements are disclosed in note 4 to the consolidated financial statements for the year ended December 31, 2020.

 

A number of new or amended standards and interpretations became applicable for financial periods beginning on or after January 1, 2021. The Group noted that the latter did not have a material impact on the Group’s financial position or disclosures made in the condensed consolidated interim financial statements.

 

Due to rounding, numbers presented throughout these condensed consolidated financial statements may not add up precisely to the totals provided. All ratios and variances are calculated using the underlying amount rather than the presented rounded amount.

 

3. Critical accounting estimates and judgments

 

The Group makes estimates and assumptions concerning the future. These estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities or may have had a significant impact on the reported results are disclosed below:

 

8

 

 

Going concern

 

The Group’s accounts are prepared on a going concern basis. To date, the Group has financed its cash requirements primarily from share issuances and licensing certain of its research and development stage products. The Group is a development-stage enterprise and is exposed to all the risks inherent in establishing a business. The Group expects that its existing cash and cash equivalents will be sufficient to fund its operations and meet all of its obligations as they fall due for at least twelve months from the date of issuance of these unaudited condensed consolidated financial statements. The future viability of the Group is dependent on its ability to raise additional capital to finance its future operations that may be delayed due to COVID 19 pandemic. The Group will seek additional funding through public or private financings or collaboration agreements. 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 remain 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 a collaboration agreement, 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 conditions.

 

COVID-19

 

In early 2020 a coronavirus disease (COVID-19) pandemic developed globally resulting in a significant number of infections and negative effects on economic activity. The Group is actively monitoring the situation and is taking any necessary measures to respond to the situation in cooperation with the various stakeholders.

 

On March 18, 2020, the Group announced the suspension of the initiation of a placebo-controlled Phase 2b/3 pivotal clinical trial of dipraglurant in levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID). The Group decided to suspend the trial based on the inability of planned clinical trial sites in the United States to initiate the trial in full compliance with the Group’s planned clinical trial procedures including with respect to data reporting, data monitoring, and the recommendations of various health authorities that the infirm patients who would participate in the trial not risk being exposed to COVID-19 at clinical trial sites. Such sites have been and may continue to be required to focus their limited resources on matters unrelated to our planned clinical trial, thereby decreasing availability, in whole or in part, for services to our planned clinical trial.

 

On June 29, 2021, the Group announced the initiation of a placebo-controlled Phase 2b/3 pivotal clinical trial of dipraglurant in PD-LID and on September 29, 2021, the Group announced the initiation of an exploratory placebo-controlled phase 2 clinical study of dipraglurant in blepharospasm.

 

Although the Group believes, based on current projections of the pandemic, that it will be able to execute the clinical trials as planned, the duration of the COVID-19 crisis is uncertain and may impact the Group’s ability to execute these clinical trials as planned. In addition, the COVID-19 pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals, including with respect to dipraglurant and our other product candidates. Any such delays could increase the cost of our clinical trials and increase the uncertainty of receiving approval from the FDA of our product candidates.

 

Depending on the duration of the COVID-19 crisis and continued negative impact on global economic activity, the Group may have to take additional measures that will have a negative impact on the Group’s business continuity and may experience certain liquidity restraints as well as incur impairments on its assets. The exact impact on the Group’s activities in 2021 and thereafter cannot be reasonably predicted. However, based on the risk mitigation measures undertaken, the Group concluded that there is no material uncertainty that may cast a significant doubt upon the Group’s ability to continue as a going concern.

 

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.

 

9

 

 

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.

 

To date, the Group has not experienced significant changes in the estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, the Group may be required to make changes to the estimates in the future as it becomes aware of additional information about the status or conduct of its research activities.

 

Research and development costs

 

The Group recognizes expenditure incurred in carrying out its research and development activities, including development supplies, until it becomes probable that future economic benefits will flow to the Group, which results in recognizing such costs as intangible assets, involving a certain degree of judgement. Currently, such development supplies are associated with pre-clinical and clinical trials of specific products that do not have any demonstrated technical feasibility.

 

Share-based compensation

 

The Group recognizes an expense for share-based compensation based on the valuation of equity incentive units using the Black-Scholes valuation model. A number of assumptions related to the volatility of the underlying shares and to the risk-free rate are made in this model. Should the assumptions and estimates underlying the fair value of these instruments vary significantly from management’s estimates, then the share-based compensation expense would be materially different from the amounts recognized.

 

Pension obligations

 

The present value of the pension obligations is calculated by an independent actuary and depends on a number of assumptions that are determined on an actuarial basis such as discount rates, future salary and pension increases, and mortality rates. Any changes in these assumptions will impact the carrying amount of pension obligations. The Group determines the appropriate discount rate at the end of each period. This is the interest rate that should be used to determine the present value of estimated future cash outflows expected to be required to settle the pension obligations. In determining the appropriate discount rate, the Group considers the interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms to maturity approximating the terms of the related pension liability. Other key assumptions for pension obligations are based in part on current market conditions.

 

4. Interim measurement note

 

Seasonality of the business: The business is not subject to any seasonality, but expenses and corresponding revenue are largely determined by the phase of the respective projects, particularly with regard to external research and development expenditures.

 

Costs: Costs that incur unevenly during the financial year are anticipated or deferred in the interim report only if it would also be appropriate to anticipate or defer such costs at the end of the financial year.

 

5. Segment reporting

 

Management has identified one single operating segment, related to the discovery, development and commercialization of small-molecule pharmaceutical products.

 

10

 

 

Information about products, services and major customers

 

External income of the Group for the three-month and nine-month periods ended September 30, 2021 and 2020 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 and grants earned.

 

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 September 30,
    For the nine months
ended September 30,
 
    2021     2020     2021     2020  
Collaborative research funding     682,002       27,264       2,518,820       1,792,117  
Grants earned     71,478       70,033       218,330       180,839  
Other service income     4,300       5,355       14,931       14,506  
Total     757,780       102,652       2,752,081       1,987,462  

 

Analysis of revenue from contract with customer and other income by major counterparties is detailed as follows:

 

    For the three months
ended September 30,
    For the nine months
ended September 30,
 
    2021     2020     2021     2020  
Indivior PLC     682,002       27,264       2,518,820       1,792,117  
Eurostars/Innosuisse     71,478       70,033       218,330       180,839  
Other counterparties     4,300       5,355       14,931       14,506  
Total     757,780       102,652       2,752,081       1,987,462  

 

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:

 

    September 30, 2021     December 31, 2020  
Switzerland     620,010       665,012  
United States of America     3,608       26,847  
France     388       389  
Total     624,006       692,248  

 

The geographical analysis of operating costs is as follows:

 

    For the three months
ended September 30,
    For the nine months
ended September 30,
 
    2021     2020     2021     2020  
Switzerland     4,324,391       3,192,154       13,952,548       12,278,647  
United States of America     8,581       19,221       25,208       62,268  
France     639       4,309       4,821       6,163  
Total operating costs (note 17)     4,333,611       3,215,684       13,982,577       12,347,078  

 

The capital expenditure during the nine-month period ended September 30, 2021 is CHF 7,063 (CHF 11,329 for the nine-month period ended September 30, 2020).

 

6. Cash and cash equivalents

 

    September 30, 2021     December 31, 2020  
Cash at bank and on hand     15,486,114       18,695,040  
Total cash and cash equivalents     15,486,114       18,695,040  

 

11

 

 

Split by currency:

 

      September 30, 2021     December 31, 2020  
CHF       65.78 %     60.53 %
USD       33.42 %     38.70 %
EUR       0.32 %     0.63 %
GBP       0.48 %     0.14 %
Total       100.00 %     100.00 %

 

The Group pays interests on CHF cash and cash equivalents and earns interests on USD cash and cash equivalents. The Group invests its cash balances into a variety of current and deposit accounts mainly with Swiss banks. In addition, the Group invests a portion of its USD cash in line with its treasury guidelines. As of December 31, 2020, non-used funds received from Eurostars/Innosuisse amount to CHF 86,481 (note 16).

 

All cash and cash equivalents were held either at banks or on hand as of September 30, 2021 and December 31, 2020.

 

7. Other current assets

 

    September 30, 2021     December 31, 2020  
Other financial assets     27,963       64,930  
Trade and other receivables     199,035       68,373  
Contract asset     383,432       -  
Prepayments     1,339,521       498,382  
Deferred costs     -       162,839  
Total other current assets     1,949,951       794,524  

 

The Group applies the IFRS 9 simplified approach to measuring expected credit losses (“ECL”), which uses a lifetime expected loss allowance for all contract assets, trade receivables and other receivables. As of September 30, 2021, the contract asset relates to the research agreement with Indivior whilst the trade and other receivables comprise of CHF 131,848 related to the grant from Eurostars/Innosuisse to be received and three non-governmental debtors whose combined outstanding balances are CHF 6,352 (four non-governmental debtors for CHF 20,577 as of December 31, 2020). The Group has considered that the contract asset and the trade 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 September 30, 2021 and December 31, 2020. The increase in prepayments as of September 30, 2021 compared to December 31, 2020 primarily relates to the Directors and Officers (D&O) Insurance premiums. As of December 31, 2020 deferred costs relate to paid legal and auditor fees associated with the preparation of the capital increase executed on January 8, 2021.

 

8. Right-of-use assets

 

    Properties     Equipment     Total  
Year ended December 31, 2020                        
Opening net book amount     496,126       47,214       543,340  
Additions     27,612       -       27,612  
Depreciation charge     (333,714 )     (25,760 )     (359,474 )
Effect of lease modifications     434,150       -       434,150  
Disposals     (72,504 )     -       (72,504 )
Exchange differences     (7,780 )     -       (7,780 )
Closing net book amount     543,890       21,454       565,344  
As of December 31, 2020                        
Cost     1,111,338       71,168       1,182,506  
Accumulated depreciation     (567,448 )     (49,714 )     (617,162 )
Net book value     543,890       21,454       565,344  

 

12

 

 

    Properties     Equipment     Total  
Period ended September 30, 2021                        
Opening net book amount     543,890       21,454       565,344  
Additions     2,000       -       2,000  
Depreciation charge     (224,579 )     (19,451 )     (244,030 )
Effect of lease modifications     174,297       17,676       191,973  
Disposals     (4,303 )     -       (4,303 )
Exchange differences     821       -       821  
Closing net book amount     492,126       19,679       511,805  
As of September 30, 2021                        
Cost     1,264,044       88,844       1,352,888  
Accumulated depreciation     (771,918 )     (69,165 )     (841,083 )
Net book value     492,126       19,679       511,805  

 

9. Property, plant and equipment

 

    Equipment     Furniture & fixtures     Chemical
library
    Total  
Year ended December 31, 2020                                
Opening net book amount     27,626       -       -       27,626  
Additions     59,414       -       -       59,414  
Depreciation charge     (19,280 )     -       -       (19,280 )
Closing net book amount     67,760       -       -       67,760  
As of December 31, 2020                                
Cost     1,682,279       7,564       1,207,165       2,897,008  
Accumulated depreciation     (1,614,519 )     (7,564 )     (1,207,165 )     (2,829,248 )
Net book value     67,760       -       -       67,760  

 

    Equipment     Furniture & fixtures     Chemical
library
    Total  
Period ended September 30, 2021                                
Opening net book amount     67,760       -       -       67,760  
Additions     7,063       -       -       7,063  
Depreciation charge     (20,617 )     -       -       (20,617 )
Closing net book amount     54,206       -       -       54,206  
As of September 30, 2021                                
Cost     1,689,342       7,564       1,207,165       2,904,071  
Accumulated depreciation     (1,635,136 )     (7,564 )     (1,207,165 )     (2,849,865 )
Net book value     54,206       -       -       54,206  

 

10. Non-current financial assets

    September 30, 2021     December 31, 2020  
Security rental deposits     57,995       59,144  
Total non-current financial assets     57,995       59,144  

 

11. Payables and accruals

    September 30, 2021     December 31, 2020  
Trade payables     1,157,170       983,545  
Social security and other taxes     110,741       171,876  
Accrued expenses     1,712,363       1,336,506  
Total payables and accruals     2,980,274       2,491,927  

 

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 increase in payables and accrued expenses as of September 30, 2021 compared to December 31, 2020, primarily relates to increased R&D activities on the dipraglurant PD LID program. The carrying amounts of payables do not materially differ from their fair values, due to their short-term nature.

 

13

 

 

 

12. Share capital

 

    Number of shares  
   

Common

shares

   

Treasury

shares

   

 

Total

 
Balance as of January 1, 2020     32,848,635       (6,243,487 )     26,605,148  
Settlement of supplier invoices     -       171,079       171,079  
Net purchase of treasury shares under liquidity agreement     -       (21,925 )     (21,925 )
Balance as of September 30, 2020     32,848,635       (6,094,333 )     26,754,302  

 

    Number of shares  
   

Common

shares

   

Treasury

shares

   

 

Total

 
Balance as of January 1, 2021     32,848,635       (5,729,861 )     27,118,774  
Issue of shares – capital increase     16,424,317       (9,524,317 )     6,900,000  
Settlement of supplier invoices     -       112,026       112,026  
Net purchase of treasury shares under liquidity agreement     -       (26,956 )     (26,956 )
Sale of treasury shares under ATM program     -       7,200       7,200  
Other net sale of treasury shares     -       39,940       39,940  
Balance as of September 30, 2021     49,272,952       (15,121,968 )     34,150,984  

 

The Company maintains a Liquidity Agreement with Kepler Capital Markets SA (“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 September 30, 2021, 81,445 (December 31, 2020: 54,489) treasury shares are recorded under this agreement in the treasury share reserve and CHF 27,963 (December 31, 2020: CHF 64,930) is recorded in other financial assets.

 

As of September 30, 2021, the total outstanding share capital is CHF 34,150,984, consisting of 34,150,984 shares excluding 15,121,968 treasury shares. As of December 31, 2020, the total outstanding share capital was CHF 27,118,774 consisting of 27,118,774 shares excluding 5,729,861 treasury shares. All shares have a nominal value of CHF 1.

 

On April 23, 2021, Addex Therapeutics Ltd issued 9,524,317 new shares from the authorized capital to its 100% owned subsidiary, Addex Pharma SA, at CHF 1. These shares are held as treasury shares.

 

On January 8, 2021, Addex Therapeutics Ltd issued 6,900,000 registered shares, with a nominal value of CHF 1 each, at an issue price of CHF 1.46. Out of the total new shares, 6,750,000 are in the form of American Depositary Shares, listed on the Nasdaq Stock Market. The gross proceeds amounted to CHF 10.1 million (USD 11.5 million) and directly related share issuance costs of CHF 1.8 million were recorded as a deduction in equity.

 

During the nine-month period ended September 30, 2021, the Group sold 39,940 treasury shares for a gross amount of CHF 80,944 under a Sale Agency Agreement entered with Kepler Cheuvreux and used 112,026 treasury shares to purchase services from consultants (September 30, 2020: 171,079) including 60,638 treasury shares for Roger Mills, the Group’s Chief Medical Officer (September 30, 2020: 92,423). The total value of consulting services settled in shares was CHF 159,455 for the nine-month period ended September 30, 2021 (CHF 229,521 for the nine-month period ended September 30, 2020). On June 30, 2021, the Company entered into a sales agreement with Cantor Fitzgerald & Co (Cantor Fitzgerald) to offer ADSs through an “at-the-market” (ATM) offering program. As of September 30, 2021, 7,200 treasury shares have been sold under the ATM offering program for a gross amount of CHF 11,082.

 

13. Share-based compensation

 

The total share-based compensation expense recognized in the statement of comprehensive loss for equity incentive units granted to directors, executives, employees and consultants for the three-month and nine-month periods ended September 30, 2021 amounts respectively to CHF 381,065 and CHF 904,016 (CHF 305,443 and CHF 946,234 for the three-month and nine-month periods ended September 30, 2020).

 

As of September 30, 2021, 8,636,464 options were outstanding (6,768,460 options as of December 31, 2020). During the nine-month period ended September 30, 2021, the Group granted 1,872,900 options with vesting over 4 years and a 10-year exercise period and 4,896 options were forfeited. Of these new options, 27,492 were granted at an exercise price of CHF 1.99 on April 1, 2021, 1,801,000 were granted at an exercise price of CHF 1.45 on May 17, 2021 and 44,408 were granted at an exercise price of CHF 1.6 on July 1, 2021.

 

14

 

 

On January 1, 2020, the exercise period of 194,687 vested options has been extended for 5 years and share-based compensation related to the fair value adjustment for the exercise period extensions of CHF 25,683 has been recognized for the nine-month period ended September 30, 2020 (CHF 4,070 for the three-month period ended September 30, 2020).

 

As of September 30, 2021 and December 31, 2020, a total of 198,750 equity sharing certificates (ESCs) were outstanding.

 

14. Retirement benefits obligations

 

The amounts recognized in the statement of comprehensive loss are as follows:

 

   

For the three months

ended September 30,

   

For the nine months

ended September 30,

 
    2021     2020     2021     2020  
Current service cost     (104,452 )     (78,932 )     (267,891 )     (236,795 )
Past service cost     -       -       219,104       102,764  
Interest cost     (6,384 )     (5,501 )     (18,505 )     (16,503 )
Interest income     3,858       3,551       11,572       10,652  
Company pension amount (note 18)     (106,978 )     (80,882 )     (55,720 )     (139,882 )

 

The conversion rates have successively changed as of January 1, 2020, and January 1, 2021, which has led to a positive past service cost for the nine-month periods ended September 30, 2020 and 2021.

 

The amounts recognized in the balance sheet are determined as follows:

 

    September 30, 2021     December 31, 2020  
Defined benefit obligation     (9,102,774 )     (9,406,967 )
Fair value of plan assets     7,885,169       7,714,430  
Funded status     (1,217,605 )     (1,692,537 )

 

15. Revenue from contract with customer

 

License & research agreement with Indivior PLC

 

On January 2, 2018, the Group entered into an agreement with Indivior for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program at the Group to discover novel GABAB PAM compounds.

 

The contract contains two distinct material promises and performance obligations: (1) the selected compound ADX71441 which falls within the definition of a licensed compound, whose rights of use and benefits thereon was transferred in January 2018 and, (2) the research services to be conducted by the Group and funded by Indivior to discover novel GABAB PAM compounds for clinical development that may be discovered over the research term of the agreement and selected by Indivior.

 

Indivior has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement. Through the Group’s participation in a joint development committee, the Group reviews, in an advisory capacity, any development programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.

 

Under terms of the agreement, the Group granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of product candidates selected by Indivior. Subject to agreed conditions, the Group and Indivior jointly own all intellectual property rights that are jointly developed and the Group or Indivior individually own all intellectual property rights that the Group or Indivior develop individually. The Group has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior including Charcot-Marie-Tooth type 1A neuropathy, or CMT1A. 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.

 

15

 

 

On February 14, 2019, Indivior terminated the development of their selected compound, ADX71441. Separately, Indivior funds research at the Group, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. The Group agreed with Indivior to an initial research term of two years, that can be extended by twelve-month increments and a minimum annual funding of USD 2 million for the Group’s R&D costs incurred. R&D costs are calculated based on the costs incurred in accordance with the contract. Following Indivior’s selection of one newly identified compound, the Group has the right to also select one additional newly identified compound. The Group is responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Group’s selected compounds. The initial two-year research term was expected to run from May 2018 to April 2020. In 2019, Indivior agreed 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 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 an additional research funding of CHF 3.7 million, of which CHF 1.4 million has been paid to the Group on August 20, 2021, a remaining amount of CHF 1.3 million is expected to be received directly by the Group and CHF 1 million paid directly by Indivior to third party suppliers that are supporting the funded research program.

 

For the three-month and nine-month periods ended September 30, 2021, the Group recognized CHF 0.7 million and CHF 2.5 million as revenue, respectively (For the three-month and the nine-month periods ended September 30, 2020, CHF 0.03 million and CHF 1.8 million, respectively) and recorded CHF 0.4 million as contract asset as of September 30, 2021 (December 31, 2020: CHF 0.7 million as contract liability).

 

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 consideration as they are contingent upon achieving uncertain, future development stages and net sales. For this reason, the Group considers the achievement of the various milestones as binary events that will be recognized as revenue upon occurrence.

 

No amounts have been recognized under this agreement in the three-month and nine-month periods ended September 30, 2021 and 2020.

 

16. Other income

 

Under a grant agreement with Eurostars/Innosuisse the Group is required to complete specific research activities within a defined period of time. The Group’s funding is fixed and received based on the satisfactory completion of the agreed research activities and incurring the related costs.

 

The Group was awarded a grant by Eurostars/Innosuisse for CHF 512,032 of which CHF 380,184 were paid as of September 30, 2021. For the three-month and nine-month periods ended September 30, 2021, the Group recognized CHF 71,478 and CHF 218,330 as other income (CHF 70,033 and CHF 180,839 for the three-month and nine-month periods ended September 30, 2020). As of September 30, 2021, the Group recognized CHF 131,848 as other receivables in accordance with the grant conditions (CHF 86,481 as short-term deferred income as of December 31, 2020).

 

For the three-month and nine-month periods ended September 30, 2021, the Group additionally recognized other income from IT consultancy agreements for CHF 4,300 and CHF 14,931 (CHF 5,355 and CHF 14,506 for the three-month and nine-month periods ended September 30, 2020).

 

16

 

 

17. Operating costs

 

   

For the three months

ended September 30,

   

For the nine months

ended September 30,

 
    2021     2020     2021     2020  
Staff costs (note 18)     1,306,553       1,061,189       3,469,897       3,278,253  
Depreciation (notes 8/9)     87,738       99,007       264,647       291,677  
External research and development costs     1,805,413       1,167,229       6,546,750       5,310,617  
Laboratory consumables     83,224       70,187       222,130       229,981  
Patent maintenance and registration costs     52,819       63,010       197,780       236,370  
Professional fees     342,410       208,441       1,271,156       1,203,687  
Short-term leases     7,330       9,676       23,767       27,010  
D&O insurance     397,604       389,506       1,193,462       1,116,391  
Other operating costs     250,520       147,439       792,988       653,092  
Total operating costs     4,333,611       3,215,684       13,982,577       12,347,078  

 

The evolution of the total operating costs is mainly driven by external research and development expenses, staff costs, professional fees, D&O insurance and other operating costs.

 

During the nine-month period ended September 30, 2021, total operating costs increased by CHF 1.6 million compared to the same period ended September 30, 2020, primarily due to increased external research and development costs of CHF 1.2 million relating to dipraglurant blepharospasm program for CHF 0.6 million and GABAB PAM program for CHF 0.3 million. During the same period, staff costs increased by CHF 0.2 million primarily due to increased R&D headcount.

 

During the three-month period ended September 30, 2021, total operating costs increased by CHF 1.1 million compared to the same period ended September 30, 2020, primarily due to increased external research and development costs of CHF 0.6 million relating to dipraglurant PD LID program for CHF 0.3 million and dipraglurant blepharospasm program for CHF 0.2 million. During the same period, staff costs increased by CHF 0.2 million primarily due to increased R&D headcount.

 

18. Staff costs

 

   

For the three months

ended September 30,

   

For the nine months

ended September 30,

 
    2021     2020     2021     2020  
Wages and salaries     798,639       668,626       2,391,241       2,170,043  
Social charges and insurances     89,866       69,042       307,472       244,922  
Value of share-based services     311,070       242,639       715,464       723,406  
Retirement benefit (note 14)     106,978       80,882       55,720       139,882  
Total staff costs     1,306,553       1,061,189       3,469,897       3,278,253  

 

19. Finance result, net

 

   

For the three months

ended September 30,

   

For the nine months

ended September 30,

 
    2021     2020     2021     2020  
Interest income     1,239       1,280       4,568       34,049  
Interest cost     (4,469 )     (8,649 )     (35,873 )     (44,126 )
Interest expense on leases     (5,520 )     (3,884 )     (17,795 )     (15,102 )
Foreign exchange (losses)/gains, net     (13,612 )     (188,749 )     351,641       (348,898 )
Finance result, net     (22,362 )     (200,002 )     302,541       (374,077 )

 

17

 

 

20. Loss per share

 

Basic and diluted loss per share is calculated by dividing the loss attributable to equity holders of the Company by the weighted average number of shares in issue during the period excluding shares purchased by the Group and held as treasury shares.

 

   

For the three months

ended September 30,

   

For the nine months

ended September 30,

 
    2021     2020     2021     2020  
Loss attributable to equity holders of the Company     (3,598,193 )     (3,313,034 )     (10,927,955 )     (10,733,693 )
Weighted average number of shares in issue     34,122,052       26,687,189       33,900,655       26,653,630  
Basic and diluted loss per share     (0.11 )     (0.12 )     (0.32 )     (0.40 )

 

The Company has three categories of dilutive potential shares as of September 30, 2021 and 2020: equity sharing certificates (“ESCs”), share options and warrants. For the three-month and nine-month periods ended September 30, 2021 and 2020, equity sharing certificates, share options and warrants have been ignored in the calculation of the loss per share, as they would be antidilutive.

 

21. Related party transactions

 

Related parties include members of the Board of Directors and the Executive Management of the Group. The following transactions were carried out with related parties:

 

Key management compensation

 

 

For the three months

ended September 30,

   

For the nine months

ended September 30,

 
    2021     2020     2021     2020  
Salaries, other short-term employee benefits and post-employment benefits     370,108       278,485       1,163,185       1,037,801  
Consulting fees     50,052       67,576       171,906       247,049  
Share-based compensation     308,545       271,946       729,766       783,331  
Total     728,705       618,007       2,064,857       2,068,181  

 

Salaries, other short-term employee benefits and post-employment benefits relate to members of the Board of Directors and Executive Management who are employed by the Group. Consulting fees relate to Roger Mills, a member of the Executive Management who delivers his services to the Group under a consulting contract. The Group has a net payable to the Board of Directors and Executive Management of CHF 117,170 as of September 30, 2021 (December 31, 2020: CHF 145,443).

 

22. Events after the balance sheet date

 

There were no material events between the balance sheet date and the date on which these financial statements were approved by the board of directors that would require adjustment to the financial statements or disclosure under this heading.

 

18

 

Exhibit 99.2

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Overview

 

We are a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators. Allosteric modulators target a specific receptor or protein and alter the effect of the body’s own signaling molecules on their target through a novel mechanism of action. These innovative small molecule drug candidates offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to existing drug treatments. To date, our research and development efforts have been primarily focused on building a portfolio of proprietary candidates based on our allosteric modulator development capability. The allosteric modulator principle has broad applicability across a wide range of biological targets and therapeutic areas, but our primary focus is on G-protein coupled receptors, or GPCR, targets implicated in neurological diseases, where we believe there is a clear medical need for new therapeutic approaches.

 

Using our allosteric modulator discovery capabilities, we have developed a pipeline of proprietary clinical and preclinical stage drug candidates. We or our partners are developing these clinical and preclinical stage proprietary drug candidates for diseases for which there are no approved therapies or where improved therapies are needed. These include levodopa induced dyskinesia associated with Parkinson’s disease, non-parkinsonian dystonia (including blepharospasm), or dystonia, epilepsy, addiction (including alcohol use disorder), Charcot-Marie-Tooth type 1A neuropathy, or CMT1A and other neurodegenerative diseases. Some of these indications are classified as rare diseases that may allow for orphan drug designation by regulatory agencies in major commercial markets, such as the United States, Europe and Japan. Orphan drug designation may entitle the recipient to benefits in the jurisdiction granting the designation, such as market exclusivity following approval and assistance in clinical trial design, a reduction in user fees or tax credits related to development expense.

 

We are developing our lead drug candidate, dipraglurant, as a metabotropic glutamate receptor subtype 5 negative allosteric modulator, or mGlu5 NAM, for the treatment of PD-LID. We are conducting a placebo-controlled Phase 2b/3 pivotal clinical trial of dipraglurant in PD-LID patients since June 2021. The clinical trial is expected to be conducted at approximately 50 sites in the United States and target enrollment of approximately 140 patients. We have received orphan drug designation from the United States Food and Drug Administration, or FDA, for dipraglurant in PD-LID and expect to report topline results in the fourth quarter of 2022. In parallel, we are developing an extended release formulation of dipraglurant as a novel orally available mGlu5 NAM for the treatment of blepharospasm. We started an exploratory placebo-controlled Phase 2 clinical trial in blepharospasm patients using the current immediate release formulation of dipraglurant in September 2021 and expect to report topline results in the first quarter of 2022.

 

Our 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. Our partner, Janssen Pharmaceuticals, Inc., or Janssen, a subsidiary of Johnson & Johnson initiated a placebo-controlled Phase 2a proof of concept clinical trial of ADX71149 in epilepsy patients in June 2021. We expect to report topline results in the third quarter of 2022. Under our agreement with Janssen, Janssen is responsible for financing the development and commercialization, if any, of ADX71149.

 

We are also conducting a research program under our strategic partnership with Indivior PLC, or Indivior, to discover novel orally available gamma-aminobutyric acid subtype B receptor positive allosteric modulators, or GABAB PAMs. We are currently in clinical candidate selection and expect IND enabling studies to be initiated in 2022. Under the terms of the agreement with Indivior, we have the right to select drug candidates for development in certain exclusive indications outside of addiction. We plan to develop our selected drug candidate in CMT1A, an indication that has been clinically validated with baclofen, an orthosteric agonist of GABAB.

 

In addition, we are conducting a number of early stage research programs including mGlu7 NAM, mGlu2 NAM, mGlu4 PAM and mGlu3 PAM.

 

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, or ADSs, representing our shares on the Nasdaq Stock Market following the United States Securities and Exchange Commission, or SEC having declared our registration statements on Forms F-1 and F-6 effective. Our operations to date have included organizing and staffing our company, raising capital, out-licensing rights to our research stage programs including our mGlu2 PAM and GABAB PAM programs and conducting research, preclinical and clinical studies.

 

1 

 

 

To date, we have generated CHF 62.9 million of revenue from the sale of license rights and conducting funded research activities for certain of our research programs. We have historically financed our operations mainly through the sale of equity. Through September 30, 2021, we had raised an aggregate of CHF 335.6 million of gross proceeds from the sale of equity. On January 8, 2021, we issued 6,900,000 new shares of which 6,750,000 were in the form of ADSs. The gross proceeds amounted to CHF 10.1 million (USD 11.5 million).

 

We have never been profitable and have incurred significant net losses in each period since our inception. Our net losses were CHF 10.9 million and CHF 10.7 million for the nine-month periods ended September 30, 2021 and September 30, 2020, respectively. As of September 30, 2021, we had accumulated losses of CHF 325 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities as we:

 

continue to invest in the research and development of our allosteric modulator discovery platform and pipeline, and specifically in connection with our Phase 2b/3 clinical trial of dipraglurant for the treatment of PD-LID and any additional clinical trials that we may conduct for product candidates;

 

hire additional research and development, and general and administrative personnel;

 

maintain, expand and protect our intellectual property portfolio;

 

identify and in-license or acquire additional product candidates; and

 

incur additional costs associated with operating as a public company in the United States.

 

We will need substantial additional funding to support our operating activities as we advance our research and product candidates through clinical development, seek regulatory approval, and if any of our product candidates are approved, prepare for commercialization. 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 clinical research organizations, or CROs, to carry out our clinical development and trials. We do not yet have a sales organization.

 

License Agreement with Indivior

 

In January 2018, we entered into an agreement with Indivior for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program at Addex to discover novel GABAB PAM compounds.

 

Indivior has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement. Through our participation in a joint development committee, we review, in an advisory capacity, any development programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.

 

Under terms of the agreement, we have granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of product 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 Charcot-Marie-Tooth type 1A neuropathy, or CMT1A. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.

 

In January 2018, under terms of the agreement, we received a non-refundable upfront fee of $5.0 million for the right to use the clinical candidate, ADX71441, including all materials and know-how related to this clinical candidate. In addition, we are eligible for payments on successful achievement of pre-specified clinical, regulatory and commercial milestones totaling $330 million, and royalties on net sales of mid-single digits to low double-digits. On February 14, 2019, Indivior terminated the development of their selected compound, ADX71441.

 

2 

 

 

Separately, Indivior funds research at Addex, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. We agreed with Indivior to an initial research term of two years, that can be extended by twelve-month increments and a minimum annual funding of $2 million for the Addex R&D costs incurred. Following Indivior’s selection of one newly identified compound, Addex has the right to also select one additional newly identified compound. Addex is responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Addex selected compounds. The initial two-year research term was expected to run from May 2018 to April 2020. In 2019, Indivior agreed an additional research funding of $1.6 million, for the research period. On October 30, 2020, the research term was extended until June 30, 2021, and Indivior agreed an additional research funding of $2.8 million. Effective May 1, 2021, the research term was extended until July 31, 2022 and Indivior agreed an additional research funding of CHF 3.7 million, of which CHF 1.4 million has been paid to the Group on August 20, 2021, a remaining amount of CHF 1.3 million is expected to be received directly by the Group and CHF 1 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 product 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.

 

Janssen has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, in the United States, Japan, the United Kingdom, Germany, France, Spain and Italy. Janssen has the right to design development programs for selected compounds under the agreement. Through our participation in a joint development committee, we review, in an advisory capacity, any development programs designed by Janssen. However, Janssen has authority over all aspects of the development of selected compounds and may develop or commercialize third-party compounds.

 

Janssen initiated a Phase 2a proof of concept clinical trial of ADX71149 in epilepsy patients in June 2021. We are eligible for a further €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 September 2021, we recognized CHF 14.9 million as revenue primarily under our license agreement with Indivior. We do not have approval to market or commercialize any of our product 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 product 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.

 

3 

 

 

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 product 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 September 2021, 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, relating to certain clinical activities related to dipraglurant development in Parkinson’s disease levodopa-induced dyskinesia, or PD-LID, and TrKB PAM discovery activities.

 

In 2019, we were funded by Eurostars/Innosuisse for CHF 0.5 million to support our mGlu7 NAM program of which CHF 0.4 million were received in October 2019 and being recognized as income from the inception of the contract. As of September 30, 2021, the Group recognized CHF 0.1 million as other receivables in accordance with the grant conditions.

 

Grants are recognized at their fair value where there is reasonable assurance that the grant will be received and that we will comply with all associated conditions. Grants relating to costs are recognized as other income in the statement of comprehensive loss over the period necessary to match them with the costs that they are intended to compensate.

 

Operating Expenses

 

Research and Development Costs

 

From the beginning of January 2017 through September 2021, we incurred CHF 39.7 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.

 

We typically use our employee, consultant and infrastructure resources across our research and development programs. We track by program the directly attributable costs from CROs and consultants.

 

The following table provides a breakdown of our outsourced research and development costs that are directly attributable to the specified programs for the three-month and nine-month periods ended September 30, 2021 and 2020:

 

   

For the three months

ended September 30,

   

For the nine months

ended September 30,

 
    2021     2020     2021     2020  
                         
    (CHF in thousands)  
Dipraglurant PD-LID     844       530       3,791       3,748  
Dipraglurant blepharospasm     189       -       608       -  
GABAB PAM     430       349       1,276       1,003  
Other discovery programs     342       288       872       560  
Total outsourced research and development costs     1,805       1,167       6,547       5,311  

 

We expect our research and development costs will increase for the foreseeable future as we seek to advance the development of our programs. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales of our product candidates.

 

4 

 

 

This is due to the numerous risks and uncertainties associated with developing such product candidates, including:

 

uncertainty related to discovering clinical candidate;

 

uncertainty related to efficiently manufacturing and distributing drug products;

 

competitor intellectual property restraining our freedom to operate;

 

the number of patients and sites required for clinical trials;

 

the length of time required to enroll patients, run clinical trials and analyze results; and

 

the results of our clinical trials.

 

In addition, the probability of success for any of our product 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 product candidates would significantly change the costs, timing and viability associated with the development of that product candidate.

 

General and Administrative Costs

 

General and administrative costs consist primarily of personnel costs, including salaries, benefits and share-based compensation cost for our employees as well as corporate facility costs not otherwise included in research and development expenses, legal fees related to corporate matters and fees for accounting and financial or tax consulting services.

 

We anticipate that our general and administrative costs will increase in the future to support continued research and development activities.

 

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 income on USD bank deposits and short-term deposits.

 

Analysis of Results of Operations

 

The following table presents our consolidated results of operations for the three-month and nine-month periods ended September 30, 2021 and 2020:

 

   

For the three months

ended September 30,

   

For the nine months

ended September 30,

 
    2021     2020     2021     2020  
                         
    (CHF in thousands)  
Revenue     682       27       2,519       1,792  
Other income     76       75       233       195  
Research and development costs     (2,862 )     (1,979 )     (9,342 )     (7,851 )
General and administrative costs     (1,472 )     (1,236 )     (4,641 )     (4,496 )
Operating loss     (3,576 )     (3,113 )     (11,231 )     (10,360 )
Finance income     (12 )     1       356       34  
Finance expense     (10 )     (201 )     (53 )     (408 )
Net loss     (3,598 )     (3,313 )     (10,928 )     (10,734 )

 

5 

 

 

Three Months Ended September 30, 2021 Compared to Three Months Ended September 30, 2020

 

Revenue

 

The following table sets forth our revenue in the three-month periods ended September 30, 2021 and 2020:

 

   

For the three months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Collaborative research funding     682       27  
Total     682       27  

 

Revenue increased by CHF 0.7 million in the three-month period ended September 30, 2021 compared to the three-month period ended September 30, 2020 primarily due to amounts received under our research agreement with Indivior which are being recognized as related costs are incurred.

 

Other Income

 

The following table sets forth our other income in the three-month periods ended September 30, 2021 and 2020:

 

   

For the three months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Research grants     72       70  
Other service income     4       5  
Total     76       75  

 

Other income remained stable in the three-month period ended September 30, 2021, compared to the three-month period ended September 30, 2020 and related primarily to amounts from our Eurostars/Innosuisse research grant award which are being recognized as related costs are incurred.

 

Research and Development Expenses

 

The following table sets forth our research and development expenses in the three-month periods ended September 30, 2021 and 2020:

 

   

For the three months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Dipraglurant PD-LID     844       530  
Dipraglurant blepharospasm     189       -  
GABAB PAM     430       349  
Other discovery programs     342       288  
    Subtotal outsourced R&D per program     1,805       1,167  
Staff costs     757       538  
Depreciation and amortization     69       80  
Laboratory consumables     83       70  
Patent maintenance and registration costs     53       63  
Short-term leases     6       7  
Other operating costs     89       54  
    Subtotal unallocated R&D expenses     1,057       812  
Total     2,862       1,979  

 

Research and development expenses increased by CHF 0.9 million in the three-month period ended September 30, 2021, compared to the three-month period ended September 30, 2020. The increase primarily relates to outsourced R&D costs for CHF 0.6 million relating to our dipraglurant PD-LID program for CHF 0.3 million and our dipraglurant blepharospasm program for CHF 0.2 million. During the same period staff costs increased by CHF 0.2 million, primarily due to increased R&D headcount.

 

6 

 

 

 

General and Administrative Costs

 

The following table sets forth our general and administrative costs in the three-month periods ended September 30, 2021 and 2020:

 

   

For the three months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Staff costs     549       523  
Depreciation and amortization     19       19  
Professional fees     342       208  
Short-term leases     1       3  
D&O insurance     398       390  
Other operating costs     163       93  
Total     1,472       1,236  

 

General and administrative costs increased by CHF 0.2 million in the three-month period ended September 30, 2021, compared to the three-month period ended September 30, 2020, primarily due to higher legal fees for CHF 0.1 million.

 

Finance Result, Net

 

   

For the three months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Interest income     1       1  
Interest cost     (4 )     (8 )
Interest expense on leases     (6 )     (4 )
Foreign exchange losses, net     (13 )     (189 )
Total     (22 )     (200 )

 

The finance result net expense decreased by CHF 0.2 million in the three-month period ended September 30, 2021 compared to the three-month period ended September 30, 2020 mainly due to reduced currency exchange losses on U.S.D cash deposits.

 

Nine Months Ended September 30, 2021 Compared to Nine Months Ended September 30, 2020

 

Revenue

 

The following table sets forth our revenue in the nine-month periods ended September 30, 2021 and 2020:

 

   

For the nine months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Collaborative research funding     2,519       1,792  
Total     2,519       1,792  

 

Revenue increased by CHF 0.7 million in the nine-month period ended September 30, 2021 compared to the nine-month period ended September 30, 2020 primarily due to amounts received under our research agreement with Indivior which are being recognized as related costs are incurred.

  

7 

 

 

Other Income

 

The following table sets forth our other income in the nine-month periods ended September 30, 2021 and 2020:

 

   

For the nine months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Research grants     218       180  
Other service income     15       15  
Total     233       195  

 

Other income remained stable in the nine-month period ended September 30, 2021 compared to the nine-month period ended September 30, 2020 and primarily related to amounts from our Eurostars/Innosuisse research grant award which are being recognized as related costs are incurred.

 

Research and Development Expenses

 

The following table sets forth our research and development expenses in the nine-month periods ended September 30, 2021 and 2020:

 

   

For the nine months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Dipraglurant PD-LID     3,791       3,748  
Dipraglurant blepharospasm     608       -  
GABAB PAM     1,276       1,003  
Other discovery programs     872       560  
    Subtotal outsourced R&D per program     6,547       5,311  
Staff costs     1,860       1,610  
Depreciation and amortization     208       235  
Laboratory consumables     222       230  
Patent maintenance and registration costs     198       236  
Short-term leases     10       17  
Other operating costs     297       212  
    Subtotal unallocated R&D expenses     2,795       2,540  
Total     9,342       7,851  

 

Research and development expenses increased by CHF 1.5 million in the nine-month period ended September 30, 2021, compared to the nine-month period ended September 30, 2020. The increase primarily relates to outsourced R&D costs for CHF 1.2 million relating to our dipraglurant blepharospasm program for CHF 0.6 million, our GABAB PAM program CHF 0.3 million and our other discovery programs for CHF 0.3 million. During the same period staff costs increased by CHF 0.3 million, primarily due to increased R&D headcount.

 

8 

 

 

General and Administrative Costs

 

The following table sets forth our general and administrative costs in the nine-month periods ended September 30, 2021 and 2020:

 

   

For the nine months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Staff costs     1,610       1,668  
Depreciation and amortization     56       57  
Professional fees     1,271       1,204  
Short-term leases     13       10  
D&O insurance     1,193       1,116  
Other operating costs     498       441  
Total     4,641       4,496  

 

General and administrative costs increased by CHF 0.1 million in the nine-month period ended September 30, 2021, compared to the nine-month period ended September 30, 2020, primarily due to increased legal fees relating to setting-up our US shelf registration and “at-the-market” (ATM) ADS equity sale program with Cantor Fitzgerald.

 

Finance Result, Net

 

   

For the nine months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Interest income     4       34  
Interest cost     (35 )     (44 )
Interest expense on leases     (18 )     (15 )
Foreign exchange (losses)/gains, net     352       (349 )
Total     303       (374 )

 

Finance result net increased by CHF 0.7 million in the nine-month period ended September 30, 2021, compared to the nine-month period ended September 30, 2020, mainly due to currency exchange differences on U.S.D cash deposits.

 

Liquidity and Capital Resources

 

Since our inception through September 30, 2021, we have generated CHF 62.9 million of revenue and have incurred net losses and negative cash flows from our operations. We have funded our operations primarily through the sale of equity. From inception through September 30, 2021, we raised an aggregate of CHF 335.6 million of gross proceeds from the sale of equity. As of September 30, 2021, we had CHF 15.5 million in cash and cash equivalents. On January 8, 2021, we issued 6,900,000 new shares of which 6,750,000 were in the form of ADSs. The gross proceeds amount to CHF 10.1 million (USD 11.5 million).

 

Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. 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.

 

We expect our expenses to increase in connection with our ongoing activities, particularly as we continue to advance our portfolio of product candidates, initiate further clinical trials and seek marketing approval for our product candidates.

 

In addition, if we obtain marketing approval for any of our product 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.

 

9 

 

 

We expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements through the fourth quarter of 2022. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

 

the scope, progress, results and costs of our ongoing and planned preclinical studies and clinical trials for dipraglurant PD-LID and dipraglurant blepharospasm programs;

 

the timing and amount of milestone and royalty payments we may receive under our license agreements;

 

the extent to which we in-license or acquire other product candidates and technologies;

 

the number and development requirements of other product candidates that we may pursue;

 

the costs, timing and outcome of regulatory review of our product candidates;

 

the duration and severity of the COVID-19 pandemic;

 

the costs associated with building out our Swiss and U.S. operations; and

 

the costs and timing of future commercialization activities, including drug manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval.

 

Identifying potential product 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 product 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 product 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 product candidates that we would otherwise prefer to develop and market ourselves.

 

The following table shows a summary of our cash flows for the periods indicated:

 

   

For the nine months ended

September 30,

 
    2021     2020  
             
    (CHF in thousands)  
Cash and cash equivalents at the beginning of the period     18,695       31,537  
Net cash flows used in operating activities     (11,760 )     (12,885 )
Net cash flows used in investing activities     (6 )     (11 )
Net cash flows from/(used in) financing activities     8,246       (444 )
Decrease in cash and cash equivalents     (3,520 )     (13,340 )
Effect of the exchange rates     311       (384 )
Cash and cash equivalents at the end of the period     15,486       17,813  

 

10 

 

 

Operating Activities

 

Net cash flows from or used in operating activities consist of the net loss adjusted for changes in working capital, and for non-cash items such as depreciation, the value of share-based services and changes in post-employment benefits.

 

During the nine-month period ended September 30, 2021, operating activities used CHF 11.8 million of cash primarily due to our net loss of CHF 10.9 million adjusted for CHF 0.3 million of finance net income that mainly relates to currency exchange gains on cash and cash equivalents and the net effect of increased net working capital of CHF 1.5 million partially offset by non-cash items of CHF 1.0 million that primarily relate to the value of the share-based services. The increased net working capital is mainly due to the variations of contract asset and liability from the research agreement funded by Indivior for CHF 1.1 million, increased prepayments for CHF 0.8 million mainly relating to D&O insurance premiums, partially offset by increased payables and accruals for CHF 0.4 million mainly relating to dipraglurant PD LID program.

 

During the nine-month period ended September 30, 2020, operating activities used CHF 12.9 million of cash primarily due to our net loss of CHF 10.7 million and the net effect of increased working capital of CHF 3.8 million, partially offset by non-cash items of CHF 1.6 million that mainly relate to the value of the share-based services. The increased net working capital is primarily due to a CHF 2.3 million reduction in accruals and payables related to our postponed dipraglurant PD-LID Phase 2b/3 pivotal clinical trial, a CHF 0.9 million decrease in contract liabilities related to our research agreement with Indivior and an increase of CHF 0.6 million in prepayment related to D&O insurance premiums, paid at the beginning of each year.

 

Investing Activities

 

Net cash used in investing activities consist primarily of investments in computer and laboratory equipment and security rental deposits related to laboratory and office space.

 

During the nine-month periods ended September 30, 2021 and 2020, net cash used in investing activities was close to nil, primarily related to investments in computers and laboratory equipment.

 

Financing Activities

 

Net cash flows from financing activities consists of proceeds from the sale of equity securities, whilst net cash flows used in financing activities primarily relate to the principal element of lease payments and associated interest expenses under IFRS 16, interest expenses on Swiss francs cash deposits and capital increase costs.

 

During the nine-month period ended September 30, 2021, net cash flows from financing activities amounted to CHF 8.2 million and consisted primarily of the net proceeds from the capital increase executed on January 8, 2021, for CHF 8.6 million which were partially offset by the principal element of lease payments and associated interest expense for CHF 0.3 million.

 

During the nine-month period ended September 30, 2020, net cash flows used in financing activities primarily related to the principal element of lease payments and associated interest expense, as well as the costs paid on issue of shares subscribed by the Group.

 

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 consolidated interim financial statements, which we have prepared in accordance with International Accounting Standard 34 Interim Financial reporting as issued by the International Accounting Standards Board.

 

11 

 

 

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, 2021 had no material impact on our financial position or disclosures made in our condensed consolidated interim financial statements.

 

JOBS Act Transition Period

 

Subject to certain conditions, as an emerging growth company, we may rely on certain of these exemptions under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, including without limitation, (1) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (2) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier to occur of (1) the last day of the fiscal year (a) December 31, 2025 (b) in which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to be a “large accelerated filer” under the rules of the U.S. Securities and Exchange Commission, which means the market value of our common shares that is held by non-affiliates exceeds $700 million as of the prior June 30, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

 

12 

 

 

 

 

 

Exhibit 99.3 

 

 

 

Addex Reports Q3 2021 Financial Results and Provides Corporate Update

 

· CHF15.5M ($16.6M) of cash and cash equivalents at September 30, 2021
· Cash used in Q3 2021 of CHF2.6M
· Dipraglurant Phase 2 blepharospasm clinical trial Initiated
· Phase 2b/3 dipraglurant study in dyskinesia associated with Parkinson’s disease on track
· Janssen led ADX71149 Phase 2 study in epilepsy on track
· Indivior GABAB PAM strategic collaboration extended with $4M additional funding

 

Ad Hoc Announcement Pursuant to Art. 53 LR

 

Geneva, Switzerland, November 4, 2021 - Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today reported its Q3 2021 financial results for the periods ended September 30, 2021 and provided a corporate update.

 

“We continue to make excellent progress throughout our pipeline as we advance all programs to their next valuable creating milestones. With the initiation of the placebo-controlled Phase 2 clinical trial of dipraglurant in blepharospasm patients, Addex now has three active clinical programs, all of which are due to readout in 2022,” said Tim Dyer, CEO of Addex. “The extension of our collaboration with Indivior and the additional $4M of funding contributed to our completing the quarter with a strong cash position of $16.6M.”

 

Q3 2021 Operating Highlights:

 

  · Initiated a placebo-controlled Phase 2 clinical trial with dipraglurant in blepharospasm patients
  · Continued to advance pivotal Phase 2b/3 dipraglurant study in dyskinesia associated with Parkinson’s disease
  · Janssen Pharmaceuticals continued to advance a Phase 2a clinical study of ADX71149 in epilepsy patients
  · Extended our strategic collaboration with Indivior to advance GABAB PAM until mid-2022 with $4M additional funding
· Continued to advance GABAB PAM drug candidates through clinical candidate selection phase
· Entered a research collaboration with the Charcot–Marie–Tooth Association (CMTA) to evaluate selected drug candidates in preclinical models of CMT1A
· Advanced Eurostars / Innosuisse funded mGlu7 NAM program for post-traumatic stress disorder
· Continued to advance preclinical programs to next value inflection points

 

Select Upcoming Milestones:

 

· Q1 22 - Phase 2a data: dipraglurant for blepharospasm
  · Q2 22 - Start IND enabling studies for GABAB PAM for Addiction and CMT1a
  · Q3 22 - Phase 2a data: ADX71149 for epilepsy
  · Q4 22 - Phase 2b/3 data: dipraglurant for dyskinesia associated with Parkinson’s disease

 

 

 

 

Key Financial Data for the three-months and nine-months ended September 30, 2021:

 

CHF’ thousands   Q3 21     Q3 20     Change     YTD 21     YTD 20     Change  
Income     758       102       656       2,752       1,987       765  
R&D expenses     (2,862 )     (1,979 )     (883 )     (9,342 )     (7,851 )     (1,491 )
G&A expenses     (1,472 )     (1,236 )     (236 )     (4,641 )     (4,496 )     (145 )
Total operating loss     (3,576 )     (3,113 )     (463 )     (11,231 )     (10,360 )     (871 )
Finance result, net     (22 )     (200 )     178       303       (374 )     677  
Net loss for the period     (3,598 )     (3,313 )     (285 )     (10,928 )     (10,734 )     (194 )
Basic and diluted net loss per share     (0.11 )     (0.12 )     0.01       (0.32 )     (0.40 )     0.08  
Net decrease in cash and cash equivalents     (2,622 )     (2,857 )     235       (3,209 )     (13,723 )     10,514  
Cash and cash equivalents as of September 30     15,486       17,813       (2,327 )     15,486       17,813       (2,327 )
Shareholders’ equity as of September 30     13,341       15,744       (2,403 )     13,341       15,744       (2,403 )

 

Financial Summary:

 

Income is primarily driven by amounts received under our funded research collaboration with Indivior. During the nine-month period ended September 30, 2021, income increased by CHF 0.8 million to CHF 2.8 million compared to the nine-month period ended September 30, 2020. During the third quarter of 2021, income increased by CHF 0.7 million compared to CHF 0.8 million in the third quarter of 2020.

 

R&D expenses increased by CHF 1.5 million to CHF 9.3 million in the nine-month period ended September 30, 2021 compared to CHF 7.9 million in the nine-month period ended September 30, 2020, due to increased outsourced R&D costs for CHF 1.2 million primarily relating to our dipraglurant blepharospasm program, GABAB PAM program and other discovery programs. During the same period staff costs increased by CHF 0.3 million, primarily due to increased R&D headcount. During the third quarter of 2021, R&D expenses increased by CHF 0.9 million compared to the third quarter of 2020 primarily due to increased outsourced R&D costs for CHF 0.6 million primarily relating to our dipraglurant PD-LID and dipraglurant blepharospasm programs. During the same period, staff costs increased by CHF 0.2 million primarily due to increased R&D headcount. Research and development expenses consist primarily of costs associated with research, preclinical and clinical testing, and related staff costs. They also include depreciation of laboratory equipment, costs of materials used in research, costs associated with renting and operating facilities and equipment, as well as fees paid to consultants, patent costs and other outside service fees and overhead costs. These expenses include costs for proprietary and third-party R&D. 

 

G&A expenses slightly increased by CHF 0.1 million to CHF 4.6 million in the nine-month period ended September 30, 2021 compared to CHF 4.5 million in the nine-month period ended September 30, 2020, primarily due to increased legal fees relating to setting-up our US shelf registration and “at-the-market” (ATM) ADS equity sale program with Cantor Fitzgerald. During the third quarter of 2021, G&A expenses increased by CHF 0.2 million compared to the third quarter of 2020, mainly due to increased legal fees.

 

The net loss is primarily driven by the evolution of income, research and development costs and financial result. During the nine-month period ended September 30, 2021, the net loss increased by CHF 0.2 million to CHF 10.9 million compared to the nine-month period ended September 30, 2020. During the third quarter of 2021, the net loss increased by CHF 0.3 million to CHF 3.6 million compared to the third quarter of 2020.

 

Basic and diluted loss per share decreased to CHF 0.32 for the nine-month period ended September 30, 2021, compared to CHF 0.40 for the nine-month period ended September 30, 2020. For the third quarter of 2021, the basic and diluted loss per share decreased to CHF 0.11 compared to CHF 0.12 for the third quarter of 2020.

 

Cash and cash equivalents amounted to CHF 15.5 million as of September 30, 2021, compared to CHF 17.8 million as of September 30, 2020. The decrease was primarily due to cash used in operating activities partially offset by the proceeds from the capital increase executed on January 8, 2021 and research funding from Indivior relating to our research collaboration.

 

 

 

 

2021 Q3 Condensed Consolidated Interim Financial Statements:

 

The Q3 2021 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, November 4, 2021, at 16:00 CET (15:00 GMT / 11:00 EDT / 08:00 PDT) to review the financial results. Tim Dyer, Chief Executive Officer, Roger Mills, Chief Medical Officer and Robert Lütjens, Head of Discovery Biology will deliver a brief presentation followed by a Q&A session.

 

Joining the Conference Call:

 

1: In the 10 minutes prior to the call start time, call the appropriate participant dial-in number.

Dial-In Numbers:

 

· Switzerland                         +41 44 580 65 22
· UK                                       +44 20 30 09 24 70
· U.S.A                                  +1 87 74 23 08 30
· Other Countries

 

2: Provide the Operator with the Participation Pin Code: 89492779#

 

Link to live event online:

 

1: In the 10 minutes prior to the call start time, sign in online by following this WebEx Link.

2: Password: Welcome

 

About Addex Therapeutics:

 

Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to conventional "orthosteric" small molecule or biological drugs. Addex's allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex's lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is in a pivotal registration clinical trial for Parkinson’s disease levodopa induced dyskinesia (PD-LID) and has entered a Phase 2 clinical study for the treatment of blepharospasm, a form of dystonia. Addex's third clinical program, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2a proof of concept clinical trial for the treatment of epilepsy. Indivior PLC has licensed Addex’s GABAB PAM program for the development of drug candidates with a focus in addiction. Preclinical programs include GABAB PAM for CMT1A, mGlu7 NAM for PTSD, mGlu2 NAM for mild neurocognitive disorders, mGlu4 PAM for Parkinson’s disease and mGlu3 PAM for neurodegenerative 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.

 

 

 

 

Contact:

 

Tim Dyer

Chief Executive Officer

Telephone: +41 22 884 15 55

PR@addextherapeutics.com

Mike Sinclair

Partner, Halsin Partners

+44 (0)20 7318 2955

msinclair@halsin.com

James Carbonara
Hayden IR
(646)-755-7412
james@haydenir.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 in respect of the anticipated initiation of clinical trials. 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 the Company’s Annual Report on Form 20-F filed with the SEC on March 11, 2021, as well as market conditions and regulatory review. 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.

 

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, except as required by law.