ADXN Addex Therapeutics Ltd

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

June 2024

 

 

Commission File Number: 001-39179

 

 

Addex Therapeutics Ltd

(Exact Name of Registrant as Specified in Its Charter)

 

 

Chemin des Mines 9,
CH-1202 Geneva,

Switzerland

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F x Form 40-F o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o

 

 

 

INCORPORATION BY REFERENCE

 

Exhibits 99.1 and 99.2 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statement on Form F-3 (Registration No. 333-255089) of Addex Therapeutics Ltd and the registration statement on Form S-8 (Registration No. 333-255124 and No. 333-272515) of Addex Therapeutics Ltd (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

 

RISK FACTORS

 

Our business faces significant risks. You should carefully consider all of the information set forth in this Report on Form 6-K and in our other filings with the United States Securities and Exchange Commission, or the SEC, including the risk factors related to our business set forth in our Annual Report on Form 20-F for the year ended December 31, 2023 filed with the Securities and Exchange Commission on April 18, 2024 and updated in our prospectus (No.333-271611) amended on April 24, 2024. Our business, financial condition, results of operations and growth prospects could be materially adversely affected by any of these risks. This report also contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements, as a result of certain factors including the risks described in our Annual Report and our other SEC filings.

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	Addex Therapeutics Ltd
	By:	/s/ Tim Dyer
		Name:	Tim Dyer
Date: June 6, 2024		Title:	Chief Executive Officer

 

 

EXHIBIT INDEX

 

Exhibit No.		Description
Exhibit 99.1 :		Unaudited Interim Condensed Consolidated Financial Statements
Exhibit 99.2 :		Management's Discussion and Analysis of Financial Condition and Result of Operations
Exhibit 99.3 :		Press Release dated June 6, 2024

 

 

 

Exhibit 99.1

 

ADDEX THERAPEUTICS LTD

 

INDEX TO UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Unaudited Interim Condensed Consolidated Financial Statements
Unaudited Interim Condensed Consolidated Balance Sheets as of March 31, 2024 and December 31, 2023	2
Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss for the three-month periods ended March 31, 2023 and 2024	3
Unaudited Interim Condensed Consolidated Statements of Changes in Equity for the three-month period ended March 31, 2023	4
Unaudited Interim Condensed Consolidated Statements of Changes in Equity for the three-month period ended March 31, 2024	5
Unaudited Interim Condensed Consolidated Statements of Cash Flows for the three-month periods ended March 31, 2023 and 2024	6
Unaudited Notes to the Interim Condensed Consolidated Financial Statements for the three-month period ended March 31, 2024	7

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements

 

Unaudited Interim Condensed Consolidated Balance Sheets

 

as of March 31, 2024, and December 31, 2023

 

		Notes		March 31, 2024				December 31, 2023
				Amounts in Swiss francs
ASSETS
Current assets
Cash and cash equivalents		6			1,627,832				3,865,481
Other financial assets		7/12			2,380				848
Trade and other receivables		7			116,246				110,361
Contract asset		7			108,801				40,907
Prepayments		7			651,567				217,008
Total					2,506,826				4,234,605
Assets classified as held for sale		20			789,880				-
Total current assets					3,296,706				4,234,605
Non-current assets
Right-of-use assets		8			32,317				330,332
Property, plant and equipment		9			-				22,604
Non-current financial assets		10			7,070				54,344
Total non-current assets					39,387				407,280
Total assets					3,336,093				4,641,885
LIABILITIES AND EQUITY
Current liabilities
Current lease liabilities					12,239				273,956
Payables and accruals		11			3,314,143				2,384,350
Deferred income					-				234,978
Total					3,326,382				2,893,284
Liabilities directly associated with assets classified as held for sale		20			1,328,218				-
Total current liabilities					4,654,600				2,893,284
Non-current liabilities
Non-current lease liabilities					22,946				70,380
Retirement benefits obligations		14			31,534				443,524
Deferred income					-				89,232
Total non-current liabilities					54,480				603,136
Equity
Share capital		12			1,843,545				1,843,545
Share premium		12			266,391,611				266,194,689
Other equity		12			64,620,223				64,620,223
Treasury shares reserve		12			(875,112	)			(909,566	)
Other reserves					30,152,127				29,814,816
Accumulated deficit					(363,505,381	)			(360,418,242	)
Total equity					(1,372,987	)			1,145,465
Total liabilities and equity					3,336,093				4,641,885

 

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

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements

 

Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss

 

for the three-month periods ended March 31, 2024 and 2023

 

				For the three months ended March 31,
		Notes		2024				2023*
				Amounts in Swiss francs
Revenue from contract with customer		15			233,480				500,892
Other income		16			1,430				1,155
Operating costs
Research and development					(245,125	)			(255,368	)
General and administration					(777,877	)			(614,335	)
Total operating costs		17			(1,023,002	)			(869,703	)
Operating loss					(788,092	)			(367,656	)
Finance income					53,525				23,826
Finance expense					(611	)			(26,179	)
Finance result		19			52,914				(2,353	)
Net loss before tax					(735,178	)			(370,009	)
Income tax expense					-				-
Net loss from continuing operations					(735,178	)			(370,009	)
Net loss from discontinued operations (attributable to equity holders of the Group)		20			(2,351,961	)			(2,037,160	)
Net loss for the period					(3,087,139	)			(2,407,169	)
Basic and diluted loss per share
From continuing operations					(0.01	)			(0.01	)
From discontinued operations					(0.02	)			(0.03	)
Total Basic and diluted loss per share for loss attributable to the ordinary equity holders of the Company		21			(0.03	)			(0.04	)
Other comprehensive loss
Items that will never be reclassified to profit and loss:
Remeasurements of retirement benefits obligation					(49,845	)			(30,641	)
Items that may be classified subsequently to profit and loss:
Exchange difference on translation of foreign operations					1,128				81
Other comprehensive loss for the period, net of tax					(48,717	)			(30,560	)
Total comprehensive loss for the period					(3,135,856	)			(2,437,729	)
From continuing operations					(736,547	)			(371,463	)
From discontinued operations					(2,399,309	)			(2,066,265	)

 

* The comparative information has been re-presented due to discontinued operations that have been reclassed to the financial line called “Net loss from discontinued operations” (note 20). In the notes of this unaudited interim condensed consolidated financial statements related to comprehensive loss information, an asterisk will remind when comparative information has been re-presented.

 

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

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements

 

Unaudited Interim Condensed Consolidated Statements of Changes in Equity

 

for the three-month period ended March 31, 2023

 

 

		Notes		Share Capital				Share Premium				Other Equity				Treasury Shares Reserve				Foreign Currency Translation Reserve				Other Reserves				Accumulated Deficit				Total
				Amounts in Swiss francs
Balance as of January 1, 2023					1,153,483				269,511,610				64,620,223				(6,278,763	)			(657,870	)			26,426,243				(349,862,015	)			4,912,911
Net loss for the period					-				-				-				-				-				-				(2,407,169	)			(2,407,169	)
Other comprehensive loss for the period					-				-				-				-				81				(30,641	)			-				(30,560	)
Total comprehensive loss for the period					-				-				-				-				81				(30,641	)			(2,407,169	)			(2,437,729	)
Cost of shares issuance					-				(4,062	)			-				-				-				-				-				(4,062	)
Value of share-based services		13			-				-				-				-				-				431,196				-				431,196
Movement in treasury shares:		12
Net purchases under liquidity agreement					-				12,775				-				(11,818	)			-				-				-				957
Sales agency agreement					-				(2,565,725	)			-				3,742,506				-				-				-				1,176,781
Costs under sale agency agreement					-				(8,826	)			-				-				-				-				-				(8,826	)
Balance as of March 31, 2023					1,153,483				266,945,772				64,620,223				(2,548,075	)			(657,789	)			26,826,798				(352,269,184	)			4,071,228

 

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

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements

 

Unaudited Interim Condensed Consolidated Statements of Changes in Equity

 

for the three-month period ended March 31, 2024

 

		Notes		Share Capital				Share Premium				Other Equity				Treasury Shares Reserve				Foreign Currency Translation Reserve				Other Reserves				Accumulated Deficit				Total
Amounts in Swiss francs
Balance as of January 1, 2024					1,843,545				266,194,689				64,620,223				(909,566	)			(659,870	)			30,474,686				(360,418,242	)			1,145,465
Net loss for the period					-				-				-				-				-				-				(3,087,139	)			(3,087,139	)
Other comprehensive loss for the period					-				-				-				-				1,128				(49,845	)			-				(48,717	)
Total comprehensive loss for the period					-				-				-				-				1,128				(49,845	)			(3,087,139	)			(3,135,856	)
Cost of pre-funded warrants exercised					-				(3,647	)			-				-				-				-				-				(3,647	)
Value of share-based services		13			-				-				-				-				-				386,028				-				386,028
Movement in treasury shares:		12
Net sales under liquidity agreement					-				(2,417	)			-				3,947				.				-				-				1,530
Sales agency agreement					-				204,750				-				30,507				-				-				-				235,257
Costs under sale agency agreement					-				(1,764	)			-				-				-				-				-				(1,764	)
Balance as of March 31, 2024					1,843,545				266,391,611				64,620,223				(875,112	)			(658,742	)			30,810,869				(363,505,381	)			(1,372,987	)

 

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

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements

 

Unaudited Interim Condensed Consolidated Statements of Cash Flows

 

for the three-month periods ended March 31, 2024 and 2023

 

				For the three months ended March 31,
		Notes		2024				2023
				Amounts in Swiss francs
Net loss for the period					(3,087,139	)			(2,407,169	)
Adjustments for:
Depreciation		8/9			70,360				75,779
Value of share-based services		13			386,028				431,196
Post-employment benefits					(28,327	)			(30,641	)
Finance cost net					(98,152	)			10,826
Increase in other financial assets		7			(1,532	)			(957	)
Decrease / (increase) in trade and other receivables		7			(5,885	)			186,462
Increase in contract asset		7			(67,894	)			(19,616	)
Increase in prepayments		7			(434,559	)			(610,525	)
Increase in payables and accruals		11			931,159				5,208
Decrease in deferred income					(324,210	)			-
Assets recorded as held for sale		20			(186,522	)			-
Liabilities recorded as held for sale		20			652,294				-
Net cash used in operating activities					(2,194,379	)			(2,359,437	)
Cash flows from investing activities
Purchase of property, plant and equipment		9			-				(2,469	)
Net cash used in investing activities					-				(2,469	)
Cash flows from financing activities
Costs paid on sale of treasury shares – shelf registration					(2,782	)			(2,356	)
Costs paid on sale of pre-funded warrants					-				(5,495	)
Costs paid on exercise of pre-funded warrants					(2,230	)			-
Sales under sale agency agreement & liquidity agreement movements		12			236,787				1,177,738
Costs paid on sale of treasury shares under sale agency agreement					(1,764	)			(8,826	)
Cost paid on issue of treasury shares		12			-				(33,247	)
Principal element of lease payment					(66,735	)			(114,017	)
Interest received		19			7,555				23,826
Interest paid		19			(6,283	)			(9,280	)
Net cash from financing activities					164,548				1,028,343
Decrease in cash and cash equivalents					(2,029,831	)			(1,333,563	)
Cash and cash equivalents at the beginning of the period		6			3,865,481				6,957,086
Asset recorded as held for sale (cash)		20			(305,809	)			-
Exchange difference on cash and cash equivalents					97,991				(28,651	)
Cash and cash equivalents at the end of the period		6			1,627,832				5,594,872

 

The Group reports significant non-cash items related to the fair value of the share-based services (note 13) and the right of use assets (note 8). The funds received from the grant Eurostars/Innosuisse and the associate deferred income have been recorded as asset and liability held for sale respectively (notes 16 and 20).

 

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

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

Unaudited Notes to the Interim Condensed Consolidated Financial Statements

 

for the three-month period ended March 31, 2024

 

(Amounts in Swiss francs)

 

1. General information

 

Addex Therapeutics Ltd (the “Company”), formerly Addex Pharmaceuticals Ltd, and its subsidiaries (together, the “Group”) are a clinical stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders.

 

The Company is a Swiss stockholding corporation domiciled c/o Addex Pharma SA, Chemin des Aulx 12, CH 1228 Plan-les-Ouates, Geneva, Switzerland and the parent company of Addex Pharma SA, Addex Pharmaceuticals France SAS, Neurosterix Pharma Sàrl, Neurosterix SA and Addex Pharmaceuticals Inc. The Groups principal place of business is Chemin des Mines 9, CH 1202 Geneva, Switzerland. Its registered shares are traded at the SIX Swiss Exchange, under the ticker symbol ADXN. On January 29, 2020, the Group listed on the Nasdaq Stock Market, American Depositary Shares (ADSs) under the symbol “ADXN”, without a new issuance of securities. ADSs represents shares that continue to be admitted to trading on SIX Swiss Exchange.

 

These interim condensed consolidated financial statements have been approved for issuance by the Board of Directors on June 5, 2024.

 

2. Basis of preparation

 

These interim condensed consolidated financial statements for the three-month period ended March 31, 2024, have been prepared under the historic cost convention and in accordance with IAS 34 “Interim Financial Reporting” and are presented in a format consistent with the consolidated financial statements under IAS 1 “Presentation of Financial Statements”. However, they do not include all of the notes that would be required in a complete set of financial statements. Thus, this interim financial report should be read in conjunction with the consolidated financial statements for the year ended December 31, 2023.

 

Interim financial results are not necessarily indicative of results anticipated for the full year. The preparation of these unaudited interim condensed consolidated financial statements made in accordance with IAS 34 requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Although these estimates are based on management’s best knowledge of current events and actions, actual results ultimately may differ from those estimates. The areas involving a higher degree of judgment which are significant to the interim condensed consolidated financial statements are disclosed in note 4 to the consolidated financial statements for the year ended December 31, 2023.

 

A number of new or amended standards and interpretations became applicable for financial reporting periods beginning on or after January 1, 2024. Of the latter, the Group noted the publication of IFRS S1 (General requirement for disclosure of sustainability-related financial information) and IFRS S2 (climate – related Disclosures). The Group concluded that those new IFRS standards were not relevant as the Group did not opt for the publication of a sustainability report in accordance with Six Swiss Exchange listing rules.

 

There are other new standards, amendments and interpretations which have been deemed by the Group as currently not relevant, hence are not listed or discussed further here.

 

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

 

Where necessary, comparative figures have been revised to conform with the current year 2024 presentation. In particular, we re-presented the unaudited interim condensed consolidated statements of comprehensive loss of the first quarter of 2023, in order to reclass discontinued operations in accordance with IFRS 5 (note 20). In addition, the ADS numbers previously disclosed have been amended following the change in ADS ratio executed on October 23, 2023, from one ADS to six shares to a new ratio of one ADS to one hundred and twenty shares. The ADS ratio change had the same effect as a one to twenty ADS reverse split and except as otherwise indicated, all information in these consolidated financial statements gives retroactive effect to the ADS Ratio Change.

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

3. Material accounting estimates and judgments

 

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

 

Going concern

 

The Group’s accounts are prepared on a going concern basis. To date, the Group has financed its cash requirements primarily from share issuances, licensing certain of its research and development stage products and selling its allosteric modulator drug discovery technology platform and a portfolio of preclinical programs. The Group is a development - stage enterprise and is exposed to all the risks inherent in establishing a business. The Group expects that its existing cash and cash equivalents, at the issuance date of these unaudited consolidated financial statements will be sufficient to fund its operations and meet all of its obligations as they fall due, through 2026. The future viability of the Group is dependent on its ability to raise additional capital through public or private financings or collaboration agreements to finance its future operations, which may be delayed due to reasons outside of the Group’s control including health pandemics and geopolitical risks. The sale of additional equity may dilute existing shareholders. The inability to obtain funding, as and when needed, would have a negative impact on the Group’s financial condition and ability to pursue its business strategies. If the Group is unable to obtain the required funding to run its operations and to develop and commercialize its product candidates, the Group could be forced to delay, reduce or stop some or all of its research and development programs to ensure it remains solvent. Management continues to explore options to obtain additional funding, including through collaborations with third parties related to the future potential development and/or commercialization of its product candidates. However, there is no assurance that the Group will be successful in raising funds, closing collaboration agreements, obtaining sufficient funding on terms acceptable to the Group, or if at all, which could have a material adverse effect on the Group’s business, results of operations and financial condition.

 

The Business of the Group could be adversely affected by health pandemics and geopolitical risks

 

The business of the Group could be adversely affected by health epidemics and geopolitical risks in regions where the Group or partners have concentrations of clinical trial sites or other business operations and could cause significant disruption in the operations of third-party manufacturers and CROs upon whom the Group or partners rely. Health pandemics may pose the risk that the Group, employees, contractors, collaborators, and partners may be prevented from conducting certain pre-clinical tests, clinical trials or other business activities for an indefinite period of time, including due to travel restrictions, quarantines, “stay-at-home” and “shelter-in-place” orders or shutdowns that have been or may in the future be requested or mandated by governmental authorities. For example, the COVID-19 pandemic has impacted and could in the future impact the business of the Group and ongoing and planning clinical trials led by the Group or partners, including as a result of delays or difficulties in clinical site initiation, difficulties in recruiting and retaining clinical site investigators and clinical site staff and interruption of the clinical supply chain or key clinical trial activities, such as clinical trial site monitoring, and supply chain interruptions caused by restrictions for the supply of materials for drug candidates or other materials necessary to manufacture product to conduct clinical and preclinical tests. Geopolitical risks such as Russia-Ukraine war or Middle East conflict may create global security concerns including the possibility of an expanded regional or global conflict and potential ramifications such as disruption of the supply chain including research and development activities being conducted by the Group and its strategic partners. The Group and partners rely on global networks of contract research organizations to engage clinical study sites and enroll patients, certain of which are in Russia and Ukraine. Delays in research and development activities of the Group and its partners could increase associated costs and, depending upon the duration of any delays, require the Group and its partners to find alternative suppliers at additional expense. In addition, Russia-Ukraine war has had significant ramifications on global financial markets, which may adversely impact the ability of the Group to raise capital on favorable terms or at all.

 

Discontinued operations, assets and liabilities held for sale related to the Neurosterix Transaction

 

During the first quarter of 2024, it became highly probable that the Group would sell a part of its business constituted by its allosteric modulator drug discovery technology platform and a portfolio of preclinical programs (see note 20). As a consequence, the group recorded assets held for sale, liabilities held for sale as of March 31, 2024 and recognized discontinued operations in the financial line of the statements of comprehensive loss called “net loss from discontinued operations” for the three month-period ended March 31, 2024 and 2023 respectively, in accordance with IFRS 5. The Group identified cash flows from discontinued operations for the three month-period ended March 31, 2024 and 2023, respectively (see note 20). The identification of assets held for sale, liabilities held for sale and discontinued operations may require some degree of judgement.

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

Revenue recognition

 

Revenue is primarily from fees related to licenses, milestones and research services. Given the complexity of the relevant agreements, judgements are required to identify distinct performance obligations, allocate the transaction price to these performance obligations and determine when the performance obligations are met. In particular, the Group’s judgement over the estimated stand-alone selling price which is used to allocate the transaction price to the performance obligations is disclosed in note 15.

 

Grants

 

Grants are recorded at their fair value when there is reasonable assurance that they will be received and recognized as income when the Group has satisfied the underlying grant conditions. In certain circumstances, grant income may be recognized before explicit grantor acknowledgement that the conditions have been met.

 

Accrued research and development costs

 

The Group records accrued expenses for estimated costs of research and development activities conducted by third party service providers. The Group records accrued expenses for estimated costs of research and development activities based upon the estimated amount of services provided, but not yet invoiced, and these costs are included in accrued expenses on the balance sheets and within research and development expenses in the statements of comprehensive loss. These costs are a significant component of research and development expenses. Accrued expenses for these costs are recorded based on the estimated amount of work completed in accordance with agreements established with these third parties. Due to the nature of estimates, the Group may be required to make changes to the estimates after a reporting period as it becomes aware of additional information about the status or conduct of its research activities.

 

Research and development costs

 

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

 

Share-based compensation

 

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

 

Equity instruments

 

The group records in equity the prefunded warrants sold to investors and the warrants granted to investors at a fair value whose valuation is calculated using Black - Scholes model.

 

Pension obligations

 

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

 

4. Interim measurement note

 

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

 

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

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

5. Segment reporting

 

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

 

Information about products, services and major customers

 

External income of the Group for the three-month period ended March 31, 2024 and 2023 is derived from the business of discovery, development and commercialization of pharmaceutical products. Income was earned from rendering of research services to a pharmaceutical company.

 

Information about geographical areas

 

External income is exclusively recorded in the Swiss operating company.

 

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

 

		For the three months Ended March 31,
		2024				2023*
Collaborative research funding			233,480				500,892
Other service income			1,430				1,155
Total			234,910				502,047

 

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

 

		For the three months Ended March 31,
		2024				2023*
Indivior PLC			233,480				500,892
Other counterparties			1,430				1,155
Total			234,910				502,047

 

For more detail, refer to note 15, “Revenue from contract with customer” and note 16 “Other income”.

 

The geographical allocation of long-lived assets is detailed as follows:

 

		March 31, 2024				December 31, 2023
Switzerland			39,037				406,946
France			350				334
Total			39,387				407,280

 

The geographical analysis of operating costs is as follows:

 

		For the three months Ended March 31,
		2024				2023*
Switzerland			1,021,074				851,459
United States of America			1,646				17,137
France			282				1,107
Total operating costs (note 17)			1,023,002				869,703

 

The capital expenditure during the three-month period ended March 31, 2024 is nil (CHF 2,469 for the three-month period ended March 31, 2023).

 

6. Cash and cash equivalents

 

		March 31, 2024				December 31, 2023
Cash at bank and on hand			1,627,832				3,865,481
Total cash and cash equivalents			1,627,832				3,865,481

 

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

Split by currency:

 

		March 31, 2024				December 31, 2023
CHF			29.99	%			39.88	%
USD			47.23	%			56.22	%
EUR			17.71	%			3.03	%
GBP			5.07	%			0.87	%
Total			100.00	%			100.00	%

 

The Group invests its cash balances into a variety of current and deposit accounts mainly with one Swiss bank whose external credit rating is P-1/A-1.

 

All cash and cash equivalents were held either at banks or on hand as of March 31, 2024 and December 31, 2023.

 

7. Other current assets

 

		March 31, 2024				December 31, 2023
Other financial assets			2,380				848
Trade and other receivables			116,246				110,361
Contract asset (Indivior PLC)			108,801				40,907
Prepayments			651,567				217,008
Total other current assets			878,994				369,124

 

Prepayments increased by CHF 0.5 million as of March 31, 2024 compared to December 31, 2023 primarily due to retirement benefits paid annually at the beginning of the year. Prepayments related to retirement benefits of employees transferred to Neurosterix on April 2, 2024 are not considered as an asset held for sale. The Group applies the IFRS 9 simplified approach to measuring expected credit losses (“ECL”), which uses a lifetime expected loss allowance for all contract assets, trade receivables and other receivables. The Group has considered that the contract asset, trade receivables and other receivables have a low risk of default based on historic loss rates and forward-looking information on macroeconomic factors affecting the ability of the third parties to settle invoices. As a result, expected loss allowance has been deemed as nil as of March 31, 2024 and December 31, 2023.

 

8. Right-of-use assets

 

Year ended December 31, 2023		Properties				Equipment				Total
Opening net book amount			353,097				4,516				357,613
Depreciation charge			(277,885	)			(2,708	)			(280,593	)
Effect of lease modifications			253,312				-				253,312
Closing net book amount			328,524				1,808				330,332

 

As of December 31, 2023		Properties				Equipment				Total
Cost			1,725,162				13,542				1,738,704
Accumulated depreciation			(1,396,638	)			(11,734	)			(1,408,372	)
Net book value			328,524				1,808				330,332

 

Period ended March 31, 2024		Properties				Equipment				Total
Opening net book amount			328,524				1,808				330,332
Depreciation charge			(66,066	)			(677	)			(66,743	)
Assets classified as held for sale			(230,141	)			(1,131	)			(231,272	)
Closing net book amount			32,317				-				32,317

 

As of March 31, 2024		Properties				Equipment				Total
Cost			95,110				-				95,110
Accumulated depreciation			(62,793	)			-				(62,793	)
Net book value			32,317				-				32,317

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

The gross value of the right of use assets decreased by CHF 1,643,594 between the periods ended December 31, 2023 and March 31, 2024. The decrease is due to the transfer of assets to Neurosterix recorded as held for sale.

 

9. Property, plant and equipment

 

Year ended December 31, 2023		Equipment				Furniture & fixtures				Chemical library				Total
Opening net book amount			41,121				-				-				41,121
Additions			6,842				-				-				6,842
Depreciation charge			(25,359	)			-				-				(25,359	)
Closing net book amount			22,604				-				-				22,604

 

As of December 31, 2023		Equipment				Furniture & fixtures				Chemical library				Total
Cost			1,721,251				7,564				1,207,165				2,935,980
Accumulated depreciation			(1,698,647	)			(7,564	)			(1,207,165	)			(2,913,376	)
Net book value			22,604				-				-				22,604

 

Period ended March 31, 2024		Equipment				Furniture & fixtures				Chemical library				Total
Opening net book amount			22,604				-				-				22,604
Depreciation charge			(3,617	)			-				-				(3,617	)
Assets classified as held for sale			(18,987	)			-				-				(18,987	)
Closing net book amount			-				-				-				-

 

As of March 31, 2024		Equipment				Furniture & fixtures				Chemical library				Total
Cost			83,502				-				-				83,502
Accumulated depreciation			(83,502	)			-				-				(83,502	)
Net book value			-				-				-				-

 

The gross value of property, plant and equipment decreased by CHF 2,852,478 between the periods ended December 31, 2023 and March 31, 2024. The decrease includes CHF 2,596,458 related to assets transferred to Neurosterix recorded as held for sale and CHF 256,020 related to disposals.

 

10. Non-current financial assets

 

		March 31, 2024				December 31, 2023
Security rental deposits			7,070				54,344
Total non-current financial assets			7,070				54,344

 

11. Payables and accruals

 

		March 31, 2024				December 31, 2023
Trade payables			1,627,961				984,384
Social security and other taxes			78,310				164,609
Accrued expenses			1,607,872				1,235,357
Total payables and accruals			3,314,143				2,384,350

 

All payables mature within 3 months. Accrued expenses and trade payables primarily relate to R&D services from contract research organizations, consultants and professional fees. The total amount of payables and accruals increased by CHF 0.9 million as of March 31, 2024 compared to December 31, 2023 mainly due to delayed payments and increased legal fees related to the Neurosterix Transaction. The carrying amounts of payables do not materially differ from their fair values, due to their short-term nature.

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

12. Share capital

 

		Number of shares
		Common shares				Treasury shares				Total
Balance as of January 1, 2023			115,348,311				(38,214,291	)			77,134,020
Sale of shares under sale agency agreement			-				3,742,506				3,742,506
Net purchase of shares under liquidity agreement			-				(5,235	)			(5,235	)
Balance as of March 31, 2023			115,348,311				(34,477,020	)			80,871,291
Shares reclassed as treasury shares under IFRS 2			-				(17,438,883	)			(17,438,883	)
Balance as of March 31, 2023 IFRS 2			115,348,311				(51,915,903	)			63,432,408

 

		Number of shares
		Common shares				Treasury shares				Total
Balance as of January 1, 2024			184,354,496				(59,159,103	)			125,195,393
Sale of shares under sale agency agreement			-				3,050,665				3,050,665
Net sale of shares under liquidity agreement			-				19,999				19,999
Balance as of March 31, 2024			184,354,496				(56,088,439	)			128,266,057
Shares reclassed as treasury shares under IFRS 2			-				(29,958,807	)			(29,958,807	)
Balance as of March 31, 2024 IFRS 2			184,354,496				(86,047,246	)			98,307,250

 

As of March 31, 2024, 128,266,057 shares were outstanding excluding 56,088,439 treasury shares directly held by Addex Pharma SA and including 29,958,807 outstanding shares benefiting from our DSPPP, considered as treasury shares under IFRS 2 (note 13). As of March 31, 2023, 80,871,291 shares were outstanding excluding 34,477,020 treasury shares directly held by Addex Pharma SA and including 17,438,883 outstanding shares benefiting from our DSPPP, considered as treasury shares under IFRS 2. All shares have a nominal value of CHF 0.01.

 

The Group maintains a liquidity agreement with Kepler Cheuvreux (“Kepler”). Under the agreement, the Group has provided Kepler with cash and shares to enable them to buy and sell the Company’s shares. As of March 31, 2024, 152,073 (December 31, 2023: 172,072) treasury shares are recorded under this agreement in the treasury share reserve and CHF 2,380 (December 31, 2023: CHF 848) is recorded in other financial assets.

 

During the three-month period ended March 31, 2024, the Group sold 3,050,665 treasury shares under the sale agency agreement with Kepler Cheuvreux at an average price of CHF 0.077 per share for gross proceeds of CHF 235,257 (during the three-month period ended March 31, 2023, the Group sold 3,742,506 treasury shares at an average price of CHF 0.31 per share for gross proceeds of CHF 1,176,781).

 

On February 20, 2024, in accordance with Swiss law, the company registered in the commercial register 6,120,000 new shares issued out of conditional capital from December 12, 2023 to December 31, 2023 following the exercise of pre-funded warrants granted to one institutional investor on April 3, 2023.

 

13. Share-based compensation

 

The total share-based compensation expense for equity incentive units recognized as continuing operating costs in the statement of comprehensive loss for the three-month period ended March 31, 2024 amounted to CHF 58,347 compared to CHF 64,673 for the three-month period ended March 31, 2023. During the same period, the total share-based compensation expense recognized in the statement of comprehensive loss under “net loss from discontinued operations” amounted to CHF 327,681 and CHF 366,523, respectively (see note 20).

 

As of March 31, 2024, 8,009,470 options were outstanding (December 31, 2023: 1,570,346). On January 8, 2024, the Group granted 6,439,124 options at an exercise price of CHF 0.05 with vesting over 4 years and a 10-year exercise period. As of March 31, 2024 and December 31, 2023, there are no equity sharing certificates (ESCs) outstanding.

 

As of March 31, 2024, and December 31, 2023, 29,958,807 shares benefiting from our Deferred Strike Price Payment Plan (DSPPP) were outstanding. All the shares benefiting from our DSPPP have been recorded as treasury shares in accordance with IFRS 2 (see note 12).

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

14. Retirement benefits obligations

 

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

 

		For the three months ended March 31,
			2024				2023*
Current service cost			(3,150	)			(3,333	)
Past service cost			1,070				1,348
Interest cost			(1,795	)			(2,349	)
Interest income			1,633				2,266
Company pension amount (note 18)			(2,242	)			(2,068	)

 

The company pension costs recognized as continuing operating costs in the statement of comprehensive loss for the three-month periods ended March 31, 2024 and March 31, 2023 were close to nil. During the same period, the total pension costs recognized in the financial line of the statement of comprehensive loss called “net loss from discontinued operations” amounted to CHF 42,493 and CHF 39,217 respectively.

 

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

 

		March 31, 2024				December 31, 2023
Defined benefit obligation			(168,997	)			(9,138,045	)
Fair value of plan assets			137,463				8,694,521
Retirement benefit obligation			(31,534	)			(443,524	)

 

Retirement benefit obligation decreased by CHF 0.4 million as of March 31, 2024 compared to December 31, 2023 because CHF 0.4 million has been recorded as liabilities held for sale following the Neurosterix Transaction (note 20).

 

15. Revenue from contract with customer

 

License & research agreement with Indivior PLC

 

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

 

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

 

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

 

Under terms of the agreement, the Group granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of product candidates selected by Indivior. Subject to agreed conditions, the Group and Indivior jointly own all intellectual property rights that are jointly developed and the Group or Indivior individually own all intellectual property rights that the Group or Indivior develop individually. The Group has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior including Cough. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.

 

In January 2018, the Group received, under the terms of the agreement, a non-refundable upfront fee of USD 5.0 million for the right to use the clinical candidate, ADX71441, including all materials and know-how related to this clinical candidate. In addition, the Group is eligible for payments on successful achievement of pre-specified clinical, regulatory and commercial milestones totaling USD 330 million and royalties on net sales of mid-single digits to low double-digits.

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

On February 14, 2019, Indivior terminated the development of their selected compound, ADX71441. Separately, Indivior funds research at the Group, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. The Group agreed with Indivior to an initial research term and duration of two years with a funding of USD 4 million over the period for the Group’s R&D costs incurred, that can be extended by twelve-month increments. R&D costs are calculated based on the costs incurred in accordance with the contract. Following Indivior’s selection of one newly identified compound, the Group has the right to also select one additional newly identified compound. The Group is responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Group’s selected compounds. The initial two-year research term was expected to run from May 2018 to April 2020. In 2019, Indivior agreed to an additional research funding of USD 1.6 million, for the research period. On October 30, 2020, the research term was extended until June 30, 2021 and Indivior agreed to additional research funding of USD 2.8 million. Effective May 1, 2021, the research term was extended until July 31, 2022 and Indivior agreed additional research funding of CHF 3.7 million, of which CHF 2.7 million was paid to the Group and CHF 1.0 million paid directly by Indivior to third party suppliers that are supporting the funded research program. In August 2022, the research agreement was extended until March 31, 2023 and Indivior agreed to additional research funding of CHF 0.85 million. The reserved indications, where Addex retains exclusive rights to develop its own independent GABAB PAM program, have also been expanded to include cough. Effective November 1, 2022, the research term was extended until June 30, 2023 and Indivior agreed to additional research funding of CHF 0.95 million. Effective July 1, 2023, the research agreement with Indivior has been extended until June 30, 2024 and Indivior committed additional research funding of CHF 2.7 million including CHF 1.1 million expected to be paid to the Group and CHF 1.6 million paid directly by Indivior to third party suppliers that are supporting the funded research program.

 

For the three-month period ended March 31, 2024, the Group recognized CHF 0.2 million as revenue in continuing operations (for the three-month period ended March 31, 2023: CHF 0.5 million) and recorded CHF 0.1 million in contract asset as of March 31, 2024 (December 31, 2023: CHF 0.1 million relating to contract assets and trade receivables).

 

Janssen Pharmaceuticals Inc. (formerly Ortho-McNeil-Janssen Pharmaceuticals Inc)

 

On December 31, 2004, the Group entered into a research collaboration and license agreement with Janssen Pharmaceuticals Inc. (JPI). In accordance with this agreement, JPI has acquired an exclusive worldwide license to develop mGlu2 PAM compounds for the treatment of human health. The Group is eligible to receive up to EUR 109 million in success-based development and regulatory milestone, and low double-digit royalties on net sales. The Group considers these various milestones to be variable considerations as they are contingent upon achieving uncertain, future development stages and net sales. For this reason, the Group considers the achievement of the various milestones as binary events that will be recognized as revenue upon occurrence.

 

No amounts have been recognized under this agreement for the three-month period ended March 31, 2024 and 2023.

 

16. Other income

 

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

 

In July 2019, the Group was awarded a grant of CHF 0.5 million by Eurostars/Innosuisse to support the mGlu7 NAM program totally recognized as income as of December 31, 2021.

 

In September 2023, the Group was awarded a grant of CHF 0.5 million by Eurostars/Innosuisse to support the mGlu2 NAM program of which CHF 0.3 million were received in December 2023. As of April 2, 2024, following the Neurosterix Transaction, other income recognized through this grant in the first quarter of 2024 has been reclassed in the statements of comprehensive loss under “net loss from discontinued operations”. The remaining funds and the associated deferred income amount of CHF 0.3 million as of March 31, 2024 has been recorded as assets and liabilities held for sale, respectively (see note 20).

 

The Group additionally recognized other income from IT consultancy agreements.

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

17. Operating costs

 

		For the three months Ended March 31,
			2024				2023*
Staff costs (note 18)			68,682				54,910
Depreciation (notes 8/9)			2,938				2,938
External research and development costs			179,110				199,902
Patent maintenance and registration costs			55,539				58,073
Professional fees			452,010				293,528
D&O insurance			51,049				156,315
Other operating costs			213,674				104,037
Total operating costs			1,023,002				869,703

 

The evolution of the total operating costs is mainly driven by professional fees and other operating costs.

 

During the three-month period ended March 31, 2024, total operating costs recognized as continuing operating costs increased by CHF 0.2 million compared to the same period ended March 31, 2023, primarily due to increased legal fees. During the same period, total operating costs recognized in the statement of comprehensive loss under “net loss from discontinued operations” remained stable at CHF 2.0 million (see note 20).

 

18. Staff costs

 

		For the three months Ended March 31,
		2024				2023*
Wages and salaries			54,284				41,162
Social charges and insurances			6,210				4,805
Value of share-based services			5,946				6,875
Retirement benefit (note 14)			2,242				2,068
Total staff costs			68,682				54,910

 

During the three-month period ended March 31, 2024, total staff costs recognized as continuing operating costs remained stable compared to the same period ended March 31, 2023. During the same period, total staff costs recognized in the financial line of the statement of comprehensive loss called “net loss from discontinued operations” increased by CHF 0.1 million (see note 20).

 

19. Finance result, net

 

		For the three months Ended March 31,
		2024				2023*
Interest income			7,571				23,826
Interest cost			(146	)			-
Interest expense on leases			(465	)			(609	)
Foreign exchange (losses)/gains, net			45,954				(25,570	)
Finance result, net			52,914				(2,353	)

 

20. Discontinued operations

 

On February 8, 2024, the Group signed a non-binding term sheet with Perceptive Advisors related to the divestment of part of its business constituted by its allosteric modulator drug discovery technology platform and a portfolio of preclinical programs. On April 2, 2024, the sale became effective (see note 23).

 

As the sale became highly probable during the first quarter of 2024, the Group has identified assets and liabilities held for sale as of March 31, 2024 and discontinued operations in the first quarter of 2024 with its comparative related to the first quarter of 2023.

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

Financial performance of discontinued operations:

 

		For the three months Ended March 31,
		2024				2023
Other income			38,401				-
Research and development			(1,320,098	)			(1,459,609	)
General and administration			(636,281	)			(572,239	)
Total operating costs			(1,956,379	)			(2,031,848	)
Operating loss			(1,917,978	)			(2,031,848	)
Finance expense			(5,672	)			(5,311	)
Net loss before tax			(1,923,650	)			(2,037,159	)
Income tax expense			-				-
Net loss from discontinued operations			(1,923,650	)			(2,037,159	)
Legal fees expenses related to the sale of discontinued operations			(428,311	)			-
Total net loss from discontinued operations			(2,351,961	)			(2,037,159	)

 

Operating costs of discontinued operations:

 

		For the three months Ended March 31,
		2024				2023
Staff costs			1,368,966				1,288,517
Depreciation			67,422				72,841
External research and development costs			331,678				508,880
Laboratory consumables			17,735				69,622
Patent maintenance and registration costs			62,563				4,269
Professional fees			38,271				-
Short-term leases			8,329				8,216
D&O insurance			-				-
Other operating costs			61,415				79,503
Total discontinued operating costs			1,956,379				2,031,848

 

Discontinued operating costs primarily driven by staff and external research and development costs remained stable at CHF 2.0 million for the three-month periods closed on March 31, 2024 and 2023.

 

Assets classified as held for sale:

 

		March 31, 2024
Cash and cash equivalents			305,809
Prepayments and other receivables			186,522
Security rental deposits			47,290
Property, plant and equipment			18,987
Right of use assets			231,272
Total Assets held for sale			789,880

 

Liabilities directly associated with assets classified as held for sale:

 

		March 31, 2024
Current lease liabilities			242,416
Payables and accruals			366,485
Deferred income			285,809
Retirement benefits obligations			433,508
Total Liabilities held for sale			1,328,218

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

Cash flows of discontinued operations:

 

		For the three months Ended March 31,
		2024				2023
Net loss from discontinued operations			(1,923,650	)			(2,037,160	)
Adjustments for:
Depreciation			67,422				72,841
Value of share-based services			327,682				366,523
Post-employment benefits			(27,338	)			(29,480	)
Finance cost net			5,672				5,311
Decrease in other receivables			2,622				126,272
Increase in prepayments			(593,142	)			(514,373	)
Increase in payables and accruals			496,472				56,614
Decrease in deferred income			(38,401	)			-
Net cash flow used in operating activities			(1,682,661	)			(1,953,452	)
Net cash flow used in investing activities
Purchase of property, plant and equipment			-				(2,469	)
Net cash used in investing activities			-				(2,469	)
Cash flows used in financing activities
Principal element of lease payment			(63,770	)			(111,196	)
Interest paid			(5,672	)			(5,311	)
Net cash used in financing activities			(69,442	)			(116,507	)
Net cash used in discontinued activities			(1,752,103	)			(2,072,428	)

 

21. Loss per share

 

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

 

		For the three months Ended March 31,
		2024				2023
Net loss from continuing operations			(735,178	)			(370,009	)
Net loss from discontinued operations			(2,351,961	)			(2,037,160	)
Net loss attributable to equity holders of the company			(3,087,139	)			(2,407,169	)
Weighted average number of shares in issue			97,534,676				61,249,364
Basic and diluted loss per share			(0.03	)			(0.04	)
From continuing operations			(0.01	)			(0.01	)
From discontinued operations			(0.02	)			(0.03	)

 

The Company has three categories of dilutive potential shares: treasury shares, share options and warrants which have been ignored in the calculation of the loss per share for the three-month periods ended March 31, 2024 and 2023, as they would be antidilutive.

 

22. Related party transactions

 

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

 

Key management compensation		For the three months Ended March 31,								For the three months Ended March 31,
		2024				2023				2024				2023
			Continuing operations								Discontinued operations
Salaries, other short-term employee benefits and post-employment benefits			59,828				34,567				319,348				313,123
Consulting fees			-				4,350				-				-
Share-based compensation			52,398				56,329				260,887				306,349
Total			112,226				95,246				580,235				619,472

 

 

Addex Therapeutics │ Unaudited Interim Condensed Consolidated Financial Statements │Notes

 

The total compensation costs to key management remain stable at CHF 0.7 million for the three-month period ended March 31, 2024 and including CHF 0.1 million recognized as continuing operations and CHF 0.6 million recognized as discontinued operations.

 

The Group has a net payable to the Board of Directors and Executive Management of CHF 0.1 million as of March 31, 2024 and December 31, 2023. Share-based compensation relates to the fair value of equity incentive units recognized through profit and loss following their vesting plan.

 

23. Events after the balance sheet date

 

On April 2, 2024, the Group divested its allosteric modulator drug discovery technology platform and a portfolio of preclinical programs to a newly formed Swiss company, Neurosterix Pharma Sàrl (Neurosterix). Neurosterix has received committed funding of USD 63 million from a syndicate of investors led by Perceptive Advisors (Perceptive Xontogeny Venture Fund II L.P, Perceptive Life Sciences Master Fund Ltd and Acorn Bioventures 2, L.P) (the “Neurosterix Transaction” or “Transaction”). As part of the Transaction, Addex received gross proceeds of CHF 5.0 million in cash and an equity interest representing 20% of Neurosterix. Addex retained its partnerships with Janssen Pharmaceuticals, Inc. and Indivior PLC, as well as unpartnered clinical stage assets including dipraglurant for Parkinson’s disease and post-stroke/TBI recovery and its preclinical GABAB PAM program for chronic cough. The Transaction includes the transfer of the associated R&D staff and infrastructure. As part of the Transaction, Addex and Neurosterix entered into a service agreement which provides Addex with access to certain staff and infrastructure to ensure the operation of the Addex retained business.

 

 

 

Exhibit 99.2

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Overview

 

We are a clinical-stage pharmaceutical company focused on the development of a portfolio of novel orally available small molecule drug candidates. Our business comprises of a pipeline of proprietary clinical and preclinical stage drug candidates that are being developed by our partners and internally. We or our partners are developing these clinical and preclinical stage proprietary drug candidates for diseases for which there are no approved therapies or where improved therapies are needed including epilepsy, Parkinson’s disease levodopa induced dyskinesia or PD-LID, post-stroke sensorimotor recovery, traumatic brain injury, or TBI, recovery, substance use disorder, or, SUD, and cough.

 

Allosteric modulators target a specific receptor or protein and alter the effect of the body’s own signaling molecules on their target through a novel mechanism of action. These innovative small molecule drug candidates offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to existing drug treatments. We believe that the allosteric modulator principle has broad applicability across a wide range of biological targets and therapeutic areas.

 

Our lead partnered drug candidate, ADX71149 is a novel orally active metabotropic glutamate receptor subtype 2 positive allosteric modulator, or mGlu2 PAM for the treatment of epilepsy. On April 29, 2024, we reported top-line data from a Phase 2 epilepsy study evaluating adjunctive ADX71149 (JNJ-40411813) administration in patients with focal onset seizures with suboptimal response to levetiracetam or brivaracetam. The Phase 2 study did not achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count when ADX71149 was added to standard of care. Under our agreement with Janssen, Janssen is responsible for financing the development and commercialization, if any, of ADX71149. We are currently working with our partner to evaluate next steps for the program.

 

Our lead wholly owned drug candidate, dipraglurant, a metabotropic glutamate receptor subtype 5 negative allosteric modulator, or mGlu5 NAM, is currently under evaluation for future development in PD-LID or post-stroke/TBI recovery. We have initiated discussions with potential partners with the objective of collaborating with them for the future development of dipraglurant.

 

We are completing a funded research program to discover novel gamma-aminobutyric acid subtype-b positive allosteric modulators, or GABAB PAMs, for Indivior PLC, or Indivior. Under the terms of the agreement with Indivior, we have the right to select GABAB PAM drug candidates for a number of reserved indications, including chronic cough. This target is clinically validated with baclofen, an orthosteric agonist of GABAB, used off label to treat cough patients. However, baclofen’s use is limited by serious side-effects, short half-life and gradual loss of efficacy during chronic treatment. By more precisely targeting the GABAB receptor with a PAM we aim to have a best-in-class treatment with improved tolerability suitable for the chronic nature of this disease. This indication has a significant unmet medical need and represents a significant commercial opportunity. We are in the late clinical candidate selection phase and have demonstrated proof-of-concept in animal models of cough with several GABAB PAM compounds. We expect to select drug candidates under the agreement with Indivior at the end of Q2 2024 and subject to securing financial resources expect to start IND enabling studies.

 

We cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our development plan or capital requirements. To date, we have secured grants and other funding from: The Michael J. Fox Foundation for Parkinson’s Research, or MJFF, for the development of dipraglurant for the treatment of PD-LID; the National Institute of Drug Abuse, or NIDA, to generate important data on the role of GABAB in substance use disorder and the Charcot-Marie-Tooth Association, or CMTA to evaluate the role of GABAB PAM compounds in preclinical models of CMT1A. As we advance our clinical and preclinical programs, we will continue to apply for subsidies, grants and government or agency sponsored studies that could offset or reduce our development costs.

 

The development and commercialization of drugs is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized pharmaceutical companies, including products approved for marketing and/or drug candidates under development, for each of the drug candidates and each of the indications for which we are developing. Furthermore, government authorities in the United States, at the federal, state and local levels, and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import and export of pharmaceutical products, such as those we are developing. The processes for obtaining regulatory approvals in the United States and in foreign countries, along with subsequent compliance with applicable statutes and regulations, require the expenditure of substantial time and financial resources.

 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

We were founded in May 2002 and completed our initial public offering of shares on the SIX Swiss Exchange in May 2007. On January 29, 2020, we listed American Depositary Shares (ADSs) representing our shares on the Nasdaq Stock Market following the United States Securities and Exchange Commission (SEC) having declared our registration statements on Forms F-1 and F-6 effective. On October 6, 2023, we filed a post-effective amendment to the form F-6 in order to change our ADS ratio from one ADS to six shares to a new ratio of one ADS to one hundred and twenty shares. The ADS ratio change has been effective since October 23, 2023 and had the same effect as a one to twenty ADS reverse split. The ADS ratio change had no impact on the Company’s underlying shares and was intended to enable the Company to regain compliance with the Nasdaq minimum bid price requirement of ADSs. On November 8, 2023, the company announced that it had received a written notification from Nasdaq confirming that the compliance had been regained. In future, we may be subject to further written notifications from Nasdaq related to the non-respect of continued listing rules such as minimum shareholders’ equity.

 

Our operations to date have included organizing and staffing our company, raising capital, out-licensing rights to our research stage programs including our mGlu2 PAM and GABAB PAM programs and conducting preclinical studies and clinical trials.

 

As of March 31, 2024, we have generated CHF 66.6 million of revenue from the sale of license rights and conducting funded research activities for certain of our research programs. We have historically financed our operations mainly through the sale of equity. Through March 31, 2024, we have raised an aggregate of CHF 355.4 million of gross proceeds from the sale of equity.

 

We have never been profitable and have incurred significant net losses in each period since our inception. Our net losses were CHF 3.1 million and CHF 2.4 million for the three-month periods ended March 31, 2024 and March 31, 2023, respectively. As of March 31, 2024, we had accumulated losses of CHF 363.5 million. We expect to continue to incur significant expenses and operating losses in the medium to long term. We anticipate that our expenses will increase significantly in connection with our ongoing and future activities as we:

 

·

continue to invest in our portfolio of preclinical and clinical stage programs;

 

·

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

 

·

maintain, expand and protect our intellectual property portfolio;

 

·

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

 

·

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

 

We will need substantial additional funding to support our operating activities as we advance our research and drug candidates through clinical development, seek regulatory approval and prepare for commercialization, if any, of our product candidates are approved. Adequate funding may not be available to us on acceptable terms, or at all.

 

We have no manufacturing facilities, and all of our manufacturing activities are contracted out to third parties. Additionally, we currently utilize third-party contractors to carry out a significant proportion of our research and development activities. Furthermore, we do not yet have a sales organization.

 

The Neurosterix Transaction

 

On April 2, 2024, we divested our allosteric modulator discovery platform and a portfolio of pre-clinical programs to a new Swiss company, Neurosterix Pharma Sàrl (equivalent to an LLC). Neurosterix is focused on the discovery and development of novel orally available allosteric modulator drug candidates, including M4 PAM for schizophrenia, mGlu7NAM for stress related disorders and mGlu2NAM for mild neurocognitive disorders. In connection with the Transaction, we received CHF 5.0 million and a 20% equity interest in Neurosterix US Holdings LLC, the sole shareholder of Neurosterix. Neurosterix received USD 63 million in funding commitments from a syndicate of investors led by Perceptive Advisors.

 

The divestment of our discovery platform and early-stage programs includes the transfer of the associated research and development staff, with a service agreement to allow key members of staff to support us in achieving our business strategy. As of the date of the Transaction, all employees of the Group, other than our Head of Finance, became employees of Neurosterix. Pursuant to the service agreement, certain former employees, including our Chief Executive Officer, will dedicate a portion of their time to the Group.

 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

License Agreement with Indivior

 

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

 

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

 

Under terms of the agreement, we have granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of drug candidates selected by Indivior. Subject to agreed conditions, Addex and Indivior jointly own all intellectual property rights that are jointly developed, and Addex or Indivior individually own all intellectual property rights that Addex or Indivior develop individually. Addex has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior including cough. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.

 

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

 

Separately, Indivior funds research at Addex, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. We agreed with Indivior to an initial research term and duration of two years with a funding of USD 4.0 million over the period for the Addex R&D costs incurred, that can be extended by twelve-month increments. R&D costs are calculated based on the costs incurred in accordance with the contract. Following Indivior’s selection of one newly identified compound, Addex has the right to also select one additional newly identified compound. Addex is responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Addex selected compounds. The initial two-year research term was expected to run from May 2018 to April 2020. In 2019, Indivior agreed an additional research funding of USD 1.6 million, for the research period. On October 30, 2020, the research term was extended until June 30, 2021 and Indivior agreed to an additional research funding of USD 2.8 million. Effective May 1, 2021, the research term was extended until July 31, 2022 and Indivior agreed additional research funding of CHF 3.7 million, of which CHF 2.7 million was paid to the Group and CHF 1.0 million paid directly by Indivior to third party suppliers that are supporting the funded research program. In August 2022, the research agreement was extended until March 31, 2023 and Indivior agreed to additional research funding of CHF 0.85 million. The reserved indications, where Addex retains exclusive rights to develop its own independent GABAB PAM program, have also been expanded to include cough. Effective November 1, 2022 the research term was extended until June 30, 2023 and Indivior agreed to additional research funding of CHF 0.95 million. Effective July 1, 2023, the research agreement with Indivior has been extended until June 30, 2024 and Indivior committed to additional research funding of CHF 2.7 million including CHF 1.1 million expected to be paid to the Group and CHF 1.6 million paid directly by Indivior to third party suppliers that are supporting the funded research program.

 

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

 

License Agreement with Janssen

 

Under our agreement with Janssen Pharmaceuticals Inc. (formerly known as Ortho-McNeil-Janssen Pharmaceuticals Inc), or Janssen, we granted Janssen an exclusive license to use relevant patents and know-how in relation to the development and commercialization of drug candidates selected by Janssen under the agreement and a non-exclusive worldwide license to conduct research on the collaboration compounds using relevant patents and know-how. Subject to certain conditions, we and they agreed to own, jointly, all intellectual property rights that we develop jointly and, individually, all intellectual property rights that either party develops individually. Under certain conditions, but subject to certain consequences, Janssen may terminate the agreement for any reason, subject to a 90-day notice period.

 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

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

 

Janssen completed a Phase 2a proof of concept clinical trial of ADX71149 in epilepsy patients in April  2024. We are eligible for a further EUR 109 million in success-based development and regulatory milestones and low double-digit royalties on net sales.

 

Components of Results of Operations

 

Revenue

 

From the beginning of January 2017 through March 31, 2024, we recognized CHF 18.6 million as revenue primarily under our license agreement with Indivior. We do not have approval to market or commercialize any of our drug candidates, we have never generated revenue from the sale of products, and we do not expect to generate any revenue from product sales for the foreseeable future. Prior to approval of a drug candidate, we will seek to generate revenue from a combination of license fees, milestone payments in connection with collaborative or strategic relationships, royalties resulting from the licensing of our drug candidates and payments from sponsored research and development activities as well as grants from governmental and non-governmental organizations.

 

Revenue from collaborative arrangements comprises the fair value for the sale of products and services, net of value-added tax, rebates and discounts. Revenue from the rendering of services is recognized in the accounting period in which the services are rendered, by reference to completion of the specific transaction assessed on the basis of the actual service provided as a proportion of the total service to be provided. Revenue from collaborative arrangements may include the receipt of non-refundable license fees, milestone payments, and research and development payments. When we have continuing performance obligations under the terms of the arrangements, non-refundable fees and payments are recognized as revenue by reference to the completion of the performance obligation and the economic substance of the agreement.

 

Our revenue has varied, and we expect revenue to continue to vary, substantially from year to year, depending on the structure and timing of milestone events, as well as our development and commercialization strategies and those of our collaboration partners for our drug candidates. We, therefore, believe that historical period to period comparisons are not meaningful and should not be relied upon as an indicator of our future revenue and performance potential.

 

Other Income

 

From the beginning of January 2017 through March 2024, we recognized CHF 1.7 million as other income including CHF 1.2 million relating to grants from The Michael J. Fox Foundation for Parkinson’s Research, or MJFF, to finance certain clinical activities related to dipraglurant development in Parkinson’s disease levodopa-induced dyskinesia, or PD-LID, and other discovery activities.

 

In July 2019, we were funded by Eurostars/Innosuisse for CHF 0.5 million to support the mGlu7 NAM program totally recognized as income as of December 31, 2021.

 

In September 2023, we were funded by Eurostars/Innosuisse for CHF 0.5 million to support the mGlu2 NAM program of which CHF 0.3 million were received in December 2023. As of April 2, 2024, following the Neurosterix Transaction, other income recognized through this grant in the first quarter of 2024 has been reclassed in the financial line of the statements of comprehensive loss called “net loss from discontinued operations”. The remaining funds and the associated deferred income have been reclassed as assets and liabilities held for sale respectively as of March 31, 2024.

 

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

 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Operating Expenses

 

Research and Development Costs

 

From the beginning of January 2017 through March 2024, we incurred CHF 66.4 million in research and development costs. They consist mainly of direct research costs, which include costs associated with the use of contract research organizations, or CROs, and consultants hired to assist on our research and development activities, personnel costs, share-based compensation for our employees and consultants, costs related to regulatory affairs and intellectual property, as well as depreciation for assets used in research and development activities. Following the sale of the allosteric modulator discovery platform and the portfolio of preclinical programs, including our M4 PAM program to Neurosterix on April 2, 2024, Research and development costs displayed further don’t include any personnel and share based compensation costs in the first quarter of 2024 and 2023 respectively, in accordance to IFRS principles as all R&D employees have been transferred to Neurosterix. Associated costs for this period have been recognized in the financial line of the statements of comprehensive loss called “net loss from discontinued operations”.

 

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

 

The following table provides a breakdown of our outsourced research and development costs from continuing operations that are directly attributable to the specified programs for the three-month period ended March 31, 2024 and 2023:

 

		For the three months Ended March 31,
		2024				2023*
Dipraglurant PD-LID			52				29
GABAB PAM			127				171
Total outsourced research and development costs – continuing operations			179				200

 

*The 2023 comparative has been re-presented in order to disclose only continuing operations following the Neurosterix transaction described above. For more information, please refer to the paragraph below related to the analysis of results of operations.

 

Our research and development expenses are low due to the Neurosterix Transaction. The table above does not reflect outsourced research and development costs related to the allosteric modulator discovery platform and the portfolio of preclinical programs, including our M4 PAM program, sold to Neurosterix and considered as discontinued operations in accordance with IFRS principles for the first quarter of 2024 and 2023 respectively. Discontinued operation costs have been reclassed in the financial line of the statements of comprehensive loss called “net loss from discontinued operations”. We have no ongoing self-funded clinical studies. In the medium and long term, our expenses may increase, particularly as we continue to the development of a GABAB PAM drug candidate, initiate further clinical trials and seek marketing approval for our drug candidates.

 

At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our drug candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales of our drug candidates. This is due to the numerous risks and uncertainties associated with developing such drug candidates, including:

 

·

uncertainty related to discovering clinical candidates;

 

·

uncertainty related to efficiently manufacturing and distributing drug products;

 

·

competitor intellectual property restraining our freedom to operate; and

 

·

timing of initiation, completion and outcome of further clinical trials;

 

In addition, the probability of success for any of our drug candidates will depend on numerous factors, including competition, manufacturing capabilities and commercial viability. A change in the outcome of any of these variables with respect to the development of any of our drug candidates would significantly change the costs, timing and viability associated with the development of that drug candidate.

 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

General and Administrative Costs

 

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

 

Our general and administrative costs are low due to Neurosterix Transaction. General and administrative costs indicated in this section are related to continuing operations. General and administrative costs related to discontinued operations have been reclassed in the financial line of the statements of comprehensive loss called “net loss from discontinued operations”.

 

Finance Result, Net

 

Finance result, net consists mainly of currency exchange differences, interest expenses relating to lease liabilities, and to the negative interest rate on Swiss franc cash deposits, partially offset by positive interest rate on USD bank deposits.

 

Net loss from discontinued operations

 

Net loss from discontinued operations relate to other income, research and development costs, general and administrative costs and finance result incurred by the allosteric modulator drug discovery technology platform and a portfolio of preclinical programs sold to Neurosterix on April 2, 2024. The net loss from discontinued operations has been reclassed in the statements of comprehensive loss under “net loss from discontinued operations”.

 

Analysis of Results of Operations

 

The following table presents our consolidated results of operations for the three-month periods ended March 31, 2024 and 2023:

 

		For the three months ended March 31,
		2024				2023*
Revenue			234				501
Other income			1				1
Research and development costs			(245	)			(255	)
General and administrative costs			(778	)			(615	)
Operating loss from continuing operations			(788	)			(368	)
Finance income			54				24
Finance expense			(1	)			(26	)
Net loss from continuing operations			(735	)			(370	)
Net loss from discontinued operations (attributable to equity holders of the Group)			(2,352	)			(2,037	)
Net loss for the period			(3,087	)			(2,407	)

 

* The comparative information has been re-presented due to discontinued operations that have been reclassed to the financial line called “Net loss from discontinued operations”, following the Neurosterix transaction described above. In the financial analysis related to the results of operations made further in the section an asterisk will remind when comparative information has been re-presented.

 

Three Months Ended March 31, 2024 Compared to Three Months Ended March 31, 2023

 

Revenue

 

The following table sets forth our revenue in the three-month periods ended March 31, 2024 and 2023:

 

		For the three months ended March 31,
		2024				2023*
		(CHF in thousands)
Collaborative research funding			234				501
Total			234				501

 

Revenue decreased by CHF 0.3 million in the three-month period ended March 31, 2024 compared to the three-month period ended March 31, 2023 due to amounts received under our agreement with Indivior which are recognized as related costs are incurred.

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Other Income

 

The following table sets forth our other income in the three-month periods ended March 31, 2024 and 2023:

 

		For the three months ended March 31,
		2024				2023*
		(CHF in thousands)
Other service income			1				1
Total			1				1

 

Other income primarily relates to IT consulting services. Other income related to Eurostars/Innosuisse grant for mGlu2 NAM has been recognized under “loss from discontinued operations” for the first quarter 2024.

 

Research and Development Expenses

 

The following table sets forth our research and development expenses in the three-month periods ended March 31, 2024 and 2023:

 

		For the three months ended March 31,
		2024				2023*
		(CHF in thousands)
Dipraglurant PD-LID			52				29
GABAB PAM			127				171
Subtotal outsourced R&D per program			179				200
Patent maintenance and registration costs			55				58
Other operating costs			11				(3	)
Subtotal unallocated R&D expenses			66				55
Total			245				255

 

Research and development expenses remain stable at CHF 0.3 million for the first quarter of 2024 and 2023 respectively. Research and development costs described in the table above for the first quarter of 2024 and 2023, respectively, relate to continuing activities that have not been sold to Neurosterix. Discontinued operations relate to the allosteric modulator discovery platform and a portfolio of preclinical programs, including our M4 PAM program, sold to Neurosterix. Costs attributed to discontinued operations are included in the statements of comprehensive loss under “net loss from discontinued operations” for the first quarter 2024 and 2023, respectively.

 

General and Administrative Costs

 

The following table sets forth our general and administrative costs in the three-month periods ended March 31, 2024 and 2023:

 

		For the three months ended March 31,
		2024				2023*
		(CHF in thousands)
Staff costs			69				55
Depreciation and amortization			3				3
Professional fees			452				294
D&O Insurance			51				156
Other operating costs			203				107
Total			778				615

 

General and administrative costs increased by CHF 0.2 million in the three-month period ended March 31, 2024, compared to the three-month period ended March 31, 2023, primarily due to increased legal fees. General and administrative costs displayed in the table above relate to the costs attributed to continuing operations in the first quarter of 2024 and 2023, respectively. Costs attributed to discontinued operations are included in the statement of comprehensive loss under “net loss from discontinued operations” for the first quarter of 2024 and 2023, respectively.

 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Finance Result, Net

 

The following table sets forth our finance result net in the three-month periods ended March 31, 2024 and 2023:

 

		For the three months ended March 31,
		2024				2023*
		(CHF in thousands)
Interest income			8				24
Interest expense on leases			(1	)			(1	)
Foreign exchange gain / (loss), net			46				(25	)
Total			53				(2	)

 

Finance result, net increased by CHF 0.1 million during the three-month period ended March 31, 2024 compared to the three-month period ended March 31, 2023, primarily due to the impact of a strengthening U.S dollar on U.S dollar cash deposits.

 

Capital Resources

 

Since our inception through March 31, 2024, we have generated CHF 66.6 million of revenue and have incurred net losses and negative cash flows from our operations. We have funded our operations primarily through the sale of equity. From inception through March 31, 2024, we raised an aggregate of CHF 355.4 million of gross proceeds from the sale of equity. As at March 31, 2024, we had CHF 1.6 million in cash and cash equivalents. Between the closing date and the issuance date of these unaudited condensed consolidated financial statements, we have raised gross proceeds of CHF 5.0 million from the sale of our allosteric modulator drug discovery technology platform and a portfolio of preclinical programs to Neurosterix. We also received a 20% equity interest in Neurosterix US Holdings LLC, the sole shareholder of Neurosterix.

 

Our primary uses of cash are to fund operating expenses, which consist mainly of research and development expenditures and associated general and administrative costs. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the changes in our outstanding accounts payable and accrued expenses. We currently have no ongoing material financing commitments, such as lines of credit or guarantees.

 

In the medium and long term, we expect an increase of our expenses compared to the three-month period ended March 31, 2024, as we continue to the development of our GABAB PAM chronic cough drug candidate, initiate further clinical trials and seek marketing approval for our drug candidates.

 

In addition, if we obtain marketing approval for any of our drug candidates, we expect to incur significant commercialization expenses related to program sales, marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

 

We expect our existing cash and cash equivalents at the issuance date of these unaudited condensed consolidated financial statements will enable us to fund our operating expenses and capital expenditure requirements through 2026. Our future viability is dependent on our ability to monetize our intellectual property portfolio and /or raise additional capital though public or private financings that may dilute existing shareholders. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:

 

·

the scope, progress, results and costs of our ongoing and planned preclinical study for our GABAB PAM cough indication drug candidate;

 

·

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

 

·

the extent to which we out-license, in-license, sell or acquire other drug candidates and technologies;

 

·

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

 

·

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

 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

·

cost associated with finding alternative suppliers due to geopolitical events such as the ongoing war in Ukraine;

 

·

the costs associated with building out our operations; and

 

·

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

 

Identifying potential drug candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our drug candidates, if approved, may not achieve commercial success. Our revenue, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all.

 

Until such time, if ever, as we can generate substantial product revenue, we may finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of any additional securities may include liquidation or other preferences that adversely affect your rights as a shareholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

 

If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

 

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

 

		For the three months ended March 31,
		2024				2023
		(CHF in thousands)
Net cash flows used in continuing operating activities			(512	)			(406	)
Net cash flows (used in) / from continuing investing activities			-				-
Net cash flows from continuing financing activities			234				1,145
Net cash (used) / from in continuing operating activities			(278	)			739

 

Operating activities of continuing operations

 

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

 

During the three-month period ended March 31, 2024, continuing operating activities used CHF 0.5 million of cash primarily due to our net loss of CHF 0.7 million partially offset for CHF 0.2 million of increased net working capital mainly due to decreased trade payables and accruals.

 

During the three-month period ended March 31, 2023, operating activities used CHF 0.4 million of cash primarily due to our net loss of CHF 0.4 million adjusted for CHF 0.1 million of increased net working capital offset by non-cash items for CHF 0.1 million mainly related to share-based services. The increase of the net working capital is mainly due to increased prepayments related to retirement benefits paid annually at the beginning of the year.

 

Investing activities of continuing operations

 

Net cash used in continuing investing activities is nil for the three-month periods ended March 31, 2024 and 2023.

 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Financing activities of continuing operations

 

Cash flows from financing activities, related to continuing continued operations, primarily consists of proceeds from the sale of equity securities.

 

During the three-month period ended March 31, 2024, net cash flows from financing activities amount to CHF 0.2 million and primarily relate to the net proceeds from the sale of treasury shares through our sale agency agreement with Kepler Cheuvreux.

 

During the three-month period ended March 31, 2023, net cash flows from financing activities amounted to CHF 1.1 million and primarily relate to the gross proceeds from the sale of treasury shares under our sale agency agreement with Kepler Cheuvreux.

 

Off-Balance Sheet Arrangements

 

As of the date of the discussion and analysis and during the period presented, we did not have, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the U.S. Securities and Exchange Commission.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Our management’s discussion and analysis of our financial condition and results of operations is based on our interim condensed consolidated financial statements, which we have prepared in accordance with International Accounting Standard 34 Interim Financial Reporting as issued by the International Accounting Standards Board.

 

Recent Accounting Pronouncements

 

The adoption of IFRS standards as issued by the IASB and interpretations issued by the IFRS interpretations committee that are effective for the first time for the financial year beginning on or after January 1, 2024 had no material impact on our financial position or disclosures made in our interim condensed consolidated financial statements.

 

JOBS Act Transition Period

 

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

 

 

 

Exhibit 99.3

 

PRESS RELEASE

 

Addex Therapeutics Reports Q1 2024 Financial Results and Provides Corporate Update

 

●

GABAB PAM: Selection of drug candidates under Indivior collaboration expected by end of Q2 2024.

 

Ad Hoc Announcement Pursuant to Art. 53 LR

 

Geneva, Switzerland, June 6, 2024 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today reported its Q1 2024 financial results and provided a corporate update.

 

“Building on the recent Neurosterix transaction, which extended our cash runway beyond 2026 and will accelerate the development of a portfolio of preclinical programs, we anticipate selection of drug candidates under the agreement with Indivior by the end of the second quarter of 2024,” said Tim Dyer CEO of Addex. “During the rest of 2024, we will focus on advancing our GABAB PAM drug candidate for chronic cough and dipraglurant for brain injury recovery as well as working with our partner, Janssen Pharmaceuticals Inc., to evaluate the future development of ADX71149.”

 

Operating Highlights:

 

·

Selection of drug candidates under the GABAB PAM collaboration with Indivior expected by the end of the second quarter of 2024;

 

·

Launched Neurosterix with Perceptive Advisors, raising USD 63 million in Series A to accelerate the development of a preclinical portfolio including M4 PAM for schizophrenia;

 

·

Received CHF 5 million and 20% equity in Neurosterix in April 2024 and secured cash runway beyond 2026; and

 

·

Our partner, Janssen Pharmaceuticals Inc., completed ADX71149 epilepsy Phase 2 study; top-line results did not show statistical significance.

 

Key Q1 2024 Financial Data

 

CHF’ thousands		Q1 2024				Q1 2023 *				Change
Income			235				502				(267	)
R&D expenses			(245	)			(255	)			10
G&A expenses			(778	)			(615	)			(163	)
Total operating loss			(788	)			(368	)			(420	)
Finance result, net			53				(2	)			55
Net loss from continuing operations			(735	)			(370	)			(365	)
Net loss from discontinued operations			(2,352	)			(2,037	)			(315	)
Net loss for the period			(3,087	)			(2,407	)			(680	)
Basic and diluted net loss per share:
From continuing operations			(0.01	)			(0.01	)			0.00
From discontinued operations			(0.02	)			(0.03	)			0.01
Total basic and diluted net loss per share			(0.03	)			(0.04	)			0.01
Net decrease in cash and cash equivalents			(2,237	)			(1,362	)			(875	)
Cash and cash equivalents			1,628				5,595				(3,967	)
Shareholders’ equity			(1,373	)			4,071				(5,444	)

 

* The comparative information has been re-presented due to discontinued operations that have been reclassed to the financial line called “Net loss from discontinued operations” following Neurosterix transaction.

 

 

Financial Summary:

 

Under IFRS, the sale of our allosteric modulator drug discovery platform and unpartnered preclinical portfolio to Neurosterix on April 2, 2024, required the identification of continuing operations related to retained programs by Addex and discontinued operations for the three-month period ended March 31, 2024 and 2023. The income and expenses from discontinued operations have been reclassed to the financial line called “Net loss from discontinued operations”. All financial variance described below relate to continuing operations.

 

Income decreased by CHF 0.3 million to CHF 0.2 million in the first quarter 2024 compared to CHF 0.5 million in the first quarter 2023, primarily driven by amounts received under our funded research collaboration with Indivior, recognized as related costs are incurred.

 

R&D expenses primarily relate to our GABAB PAM program and remain stable at CHF 0.3 million for both first quarters of 2024 and 2023.

 

G&A expenses increased by CHF 0.2 million to CHF 0.8 million in the first quarter 2024 compared to CHF 0.6 million in the first quarter 2023, primarily due to legal fees.

 

The net loss from continuing operations increased by CHF 0.4 million primarily due to reduced income and increased G&A.

 

Basic and diluted loss per share from continuing operations remain stable at CHF 0.01 for the first quarter 2024 compared to the first quarter 2023.

 

Cash and cash equivalents decreased to CHF 1.6 million at March 31, 2024, compared to CHF 5.6 million at March 31, 2023. The decrease of CHF 5.4 million between March 31, 2024 and March 31, 2023 is primarily due to the cash used in operating activities, partially offset by funds raised from one single institutional investor in April 2023. Gross proceeds of CHF 5.0 million from Neurosterix’s transaction was received in April 2024.

 

Q1 2024 Consolidated Financial Statements:

 

The Q1 2024 financial report can be found on the Company’s website in the investor/download section here.

 

Conference Call Details:

 

A conference call will be held today, June 6, 2024, at 16:00 CEST (15:00 BST / 10:00 EDT / 07:00 PDT) to review the financial results. Tim Dyer, Chief Executive Officer and Misha Kalinichev, Head of Translational Science will deliver a brief presentation followed by a Q&A session.

 

Joining the Conference Call:

 

1.

Participants are required to register in advance of the conference using the link provided below. Upon registering, each participant will be provided with Participant Dial-in numbers, and a unique Personal PIN.

 

2.

In the 10 minutes prior to the call’s start time, participants will need to use the conference access information provided in the e-mail received at the point of registering. Participants may also use the call me feature instead of dialing the nearest dial in number.

 

Webcast registration URL:

https://edge.media-server.com/mmc/p/5twaqd3r

 

Conference call registration URL:

https://register.vevent.com/register/BI042149b2b22741eb96c2d718ff2853bb

 

About Addex:

 

Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders. Addex’s lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals Inc., has recently completed a Phase 2 clinical study for the treatment of epilepsy. The Company’s second clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in dyskinesia associated with Parkinson’s disease and post-stroke/TBI recovery. Addex partnership with Indivior on GABAB PAM is advancing multiple drug candidates through clinical candidate selection for substance use disorder. Under the agreement with Indivior, Addex is advancing an independent GABAB PAM program for chronic cough through clinical candidate selection. Addex also holds a 20% share in a private company, Neurosterix LLC which is advancing a portfolio of allosteric modulator programs including M4PAM for schizophrenia, mGlu7NAM for stress related disorders and mGlu2NAM for mild neurocognitive disorders. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol “ADXN” on each exchange. For more information, visit www.addextherapeutics.com

 

 

Contacts:

 

Tim Dyer Chief Executive Officer Telephone: +41 22 884 15 55 PR@addextherapeutics.com

Mike Sinclair Partner, Halsin Partners +44 (0)7968 022075 msinclair@halsin.com

 

Addex Forward Looking Statements:

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F for the year ended December 31, 2023, as filed with the SEC on April 18, 2024, the final prospectus supplement and accompanying prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

 

 

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