Addex Therapeutics(ADXN)
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Addex and Perceptive Launch Neurosterix with $63 Million to Accelerate Development of Allosteric Modulator Therapeutics for Neurological Disorders
Newsfilter· 2024-04-03 05:00
Addex receives CHF5M and 20% share of Neurosterix Perceptive Advisors leads $63M investment into Neurosterix Addex contributes portfolio of preclinical neuroscience assets and allosteric modulator small molecule discovery technology platform to Neurosterix Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland and New York, USA, April 3, 2024 - Addex Therapeutics (NASDAQ:ADXN), a clinical-stage biopharmaceutical company pioneering allosteric modulation-based drug development, and funds affiliated ...
Addex to Present at the Bio-Europe Spring 2024 Conference
Globenewswire· 2024-03-14 06:00
Core Insights - Addex Therapeutics is a clinical-stage pharmaceutical company focused on allosteric modulation-based drug discovery and development [2] - The company will present a corporate update at the Bio-Europe Spring 2024 conference in Barcelona, Spain, from March 18-20, 2024 [1] Company Overview - Addex Therapeutics specializes in developing novel orally available small molecule drugs known as allosteric modulators for neurological disorders [2] - The lead drug candidate, ADX71149, is a positive allosteric modulator (PAM) for mGlu2 and is currently in Phase 2 clinical trials for epilepsy [2] - The second clinical program, dipraglurant, is a negative allosteric modulator (NAM) for mGlu5, under evaluation for post-stroke recovery [2] - Indivior PLC has licensed Addex's GABAB PAM program for substance use disorder development [2] - The company is advancing a preclinical pipeline targeting various conditions, including chronic cough, stress-related disorders, schizophrenia, and mild neurocognitive disorders [2] - Addex shares are listed on the SIX Swiss Exchange and NASDAQ Capital Market under the ticker symbol "ADXN" [2]
Addex to Present at the Swiss Equities Baader Conference
Newsfilter· 2024-01-09 06:00
Geneva, Switzerland, January 9, 2024 - Addex Therapeutics (NASDAQ:ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today announced that Dr Robert Lütjens, Head of Discovery - Biology, will present at the Swiss Equities Baader Conference being held in Bad Ragaz, Switzerland, January 10-12, 2024. In his presentation, Dr Lütjens will provide a corporate update and discuss recent advances from Addex's CNS pipeline. Presentation Details:Date: T ...
Addex to Present at the Swiss Equities Baader Conference
Globenewswire· 2024-01-09 06:00
Company Overview - Addex Therapeutics is a clinical-stage pharmaceutical company focused on developing and commercializing allosteric modulators for neurological disorders [2] - The company’s lead drug candidate, ADX71149, is a positive allosteric modulator in Phase 2 clinical trials for epilepsy [2] - Addex is also advancing a preclinical pipeline targeting various neurological conditions, including chronic cough, stress-related disorders, schizophrenia, and mild neurocognitive disorders [2] Recent Developments - Dr. Robert Lütjens, Head of Discovery - Biology, will present a corporate update and discuss advances in Addex's CNS pipeline at the Swiss Equities Baader Conference from January 10-12, 2024 [1] - The presentation is scheduled for January 11, 2024, at 16:20 CET in Bad Ragaz, Switzerland [1] Collaboration and Licensing - Indivior PLC has licensed Addex's GABAB PAM program for developing drug candidates focused on substance use disorder [2] - The collaboration with Janssen Pharmaceuticals for ADX71149 highlights Addex's strategic partnerships in drug development [2]
Addex to Present at Biotech Showcase™ 2024
Newsfilter· 2024-01-05 06:30
Core Insights - Addex Therapeutics is a clinical-stage pharmaceutical company focused on allosteric modulation for neurological disorders, with a pipeline that includes several promising drug candidates [2] Group 1: Corporate Update - CEO Tim Dyer will present at the Biotech Showcase in San Francisco on January 8, 2024, discussing recent advances in Addex's CNS pipeline [1] - The presentation will cover key programs including ADX71149 for epilepsy, dipraglurant for post-stroke recovery, and partnerships for substance use disorders [1][2] Group 2: Pipeline Overview - ADX71149 is currently in Phase 2 clinical trials for epilepsy in collaboration with Janssen Pharmaceuticals [2] - Dipraglurant is being evaluated for post-stroke recovery, while the GABAB PAM program has been licensed to Indivior for substance use disorder treatment [2] - The company is also advancing preclinical programs targeting chronic cough, stress-related disorders, schizophrenia, and mild neurocognitive disorders [2]
Addex to Present at Biotech Showcase™ 2024
Globenewswire· 2024-01-05 06:30
Core Insights - Addex Therapeutics is a clinical-stage pharmaceutical company focused on allosteric modulation for neurological disorders, with a pipeline that includes several promising drug candidates [2] Group 1: Corporate Update - CEO Tim Dyer will present at the Biotech Showcase in San Francisco on January 8, 2024, discussing recent advances in Addex's CNS pipeline [1] - The presentation will cover key programs including ADX71149 for epilepsy, dipraglurant for post-stroke recovery, and partnerships for substance use disorders [1][2] Group 2: Pipeline Overview - ADX71149 is currently in Phase 2 clinical trials for epilepsy in collaboration with Janssen Pharmaceuticals [2] - Dipraglurant is being evaluated for post-stroke recovery, while the GABAB PAM program has been licensed to Indivior for substance use disorders [2] - Additional preclinical programs include GABAB PAM for chronic cough, mGlu7 NAM for stress-related disorders, M4 PAM for schizophrenia, and mGlu2 NAM for mild neurocognitive disorders and depression [2]
Addex Therapeutics(ADXN) - 2023 Q3 - Earnings Call Presentation
2023-11-29 18:43
Innovative Treatments for Central Nervous System Disorders November 2023 Allosteric modulators for human health Disclaimer These materials do not constitute or form part, or all, of any offer or invitation to sell or issue, neither in the United States of America nor elsewhere, or any solicitation of any offer to purchase or subscribe for, any securities, nor shall part, or all, of these materials or their distribution form the basis of, or be relied on in connection with, any contract or investment decisio ...
Addex Therapeutics(ADXN) - 2023 Q3 - Earnings Call Transcript
2023-11-29 18:41
Addex Therapeutics Ltd. (NASDAQ:ADXN) Q3 2023 Earnings Conference Call November 29, 2023 10:00 AM ET Company Participants Tim Dyer - Chief Executive Officer Robert Lutjens - Head of Discovery-Biology Mikhail Kalinichev - Head of Translational Science Conference Call Participants Operator Good day and thank you for standing by. Welcome to the Addex Therapeutics Third Quarter 2023 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. After the speake ...
Addex Therapeutics(ADXN) - 2023 Q3 - Quarterly Report
2023-11-28 16:00
[Unaudited Interim Condensed Consolidated Financial Statements](index=2&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [Unaudited Interim Condensed Consolidated Balance Sheets](index=2&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Balance%20Sheets) The balance sheet provides a snapshot of the company's financial position as of September 30, 2023, compared to December 31, 2022, showing a decrease in total assets and total equity, primarily driven by a reduction in cash and cash equivalents and current liabilities Consolidated Balance Sheet Summary | Metric | Sep 30, 2023 (CHF) | Dec 31, 2022 (CHF) | Change (CHF) | Change (%) | | :---------------------- | :----------------- | :----------------- | :----------- | :--------- | | Total assets | 6,138,100 | 8,282,050 | (2,143,950) | -25.89% | | Current assets | 5,742,707 | 7,828,961 | (2,086,254) | -26.65% | | Cash and cash equivalents | 4,754,107 | 6,957,086 | (2,202,979) | -31.67% | | Total liabilities | 2,193,665 | 3,369,139 | (1,175,474) | -34.90% | | Current liabilities | 1,930,995 | 3,282,111 | (1,351,116) | -41.16% | | Total equity | 3,944,435 | 4,912,911 | (968,476) | -19.71% | [Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss](index=3&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The company reported a significant reduction in net loss and total comprehensive loss for both the three-month and nine-month periods ended September 30, 2023, compared to the same periods in 2022, primarily driven by decreased operating costs, especially in research and development Consolidated Statements of Comprehensive Loss Summary | Metric (CHF) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | Change (CHF) | Change (%) | | :---------------------------- | :-------------------------- | :-------------------------- | :----------- | :--------- | | Revenue | 327,733 | 409,417 | (81,684) | -19.95% | | Operating costs | (2,981,825) | (4,582,666) | 1,600,841 | -34.93% | | Operating loss | (2,652,607) | (4,166,967) | 1,514,360 | -36.34% | | Net loss for the period | (2,617,070) | (4,107,630) | 1,490,560 | -36.29% | | Total comprehensive loss | (2,642,501) | (3,974,734) | 1,332,233 | -33.52% | | Basic and diluted loss per share | (0.03) | (0.09) | 0.06 | -66.67% | | Metric (CHF) | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | Change (CHF) | Change (%) | | :---------------------------- | :-------------------------- | :-------------------------- | :----------- | :--------- | | Revenue | 1,459,502 | 830,008 | 629,494 | 75.84% | | Operating costs | (9,062,130) | (17,867,857) | 8,805,727 | -49.28% | | Operating loss | (7,598,888) | (17,021,767) | 9,422,879 | -55.36% | | Net loss for the period | (7,699,391) | (17,152,617) | 9,453,226 | -55.11% | | Total comprehensive loss | (7,891,373) | (15,874,718) | 7,983,345 | -50.30% | | Basic and diluted loss per share | (0.11) | (0.42) | 0.31 | -73.81% | [Unaudited Interim Condensed Consolidated Statements of Changes in Equity](index=4&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) The statements of changes in equity reflect a decrease in total equity for both the nine-month and three-month periods ended September 30, 2023, primarily due to net losses, despite capital-raising activities through share and warrant sales. Significant movements include the issuance and sale of treasury shares and pre-funded warrants Changes in Equity (Nine-Month Period Ended Sep 30, 2023 vs. Jan 1, 2023) | Metric (CHF) | Jan 1, 2023 | Sep 30, 2023 | Change (CHF) | | :------------------------ | :------------ | :------------ | :----------- | | Total Equity | 4,912,911 | 3,944,435 | (968,476) | | Net loss for the period | - | (7,699,391) | (7,699,391) | | Other comprehensive loss | - | (191,982) | (191,982) | | Sales under shelf registration | - | 1,159,759 | 1,159,759 | | Sale of pre-funded warrants | - | 3,382,259 | 3,382,259 | | Exercise of pre-funded warrants | - | 300 | 300 | | Sales agency agreement | - | 1,176,781 | 1,176,781 | Changes in Equity (Three-Month Period Ended Sep 30, 2023 vs. Jun 30, 2023) | Metric (CHF) | Jun 30, 2023 | Sep 30, 2023 | Change (CHF) | | :------------------------ | :------------ | :------------ | :----------- | | Total Equity | 6,126,103 | 3,944,435 | (2,181,668) | | Net loss for the period | - | (2,617,070) | (2,617,070) | | Other comprehensive loss | - | (25,431) | (25,431) | | Exercise of pre-funded warrants | - | 261 | 261 | | Value of share-based services | - | 483,464 | 483,464 | [For the nine-month periods ended September 30, 2023 and 2022](index=4&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity%20for%20the%20nine-month%20periods%20ended%20September%2030,%202023%20and%202022) [For the three-month periods ended September 30, 2022](index=5&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity%20for%20the%20three-month%20periods%20ended%20September%2030,%202022) [For the three-month periods ended September 30, 2023](index=6&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity%20for%20the%20three-month%20periods%20ended%20September%2030,%202023) [Unaudited Interim Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The company experienced a significant decrease in cash and cash equivalents for the nine-month period ended September 30, 2023, primarily due to net cash used in operating activities, despite positive cash flows from financing activities Consolidated Statements of Cash Flows Summary (Nine-Month Period) | Metric (CHF) | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | Change (CHF) | Change (%) | | :------------------------------------------ | :-------------------------- | :-------------------------- | :----------- | :--------- | | Net loss for the period | (7,699,391) | (17,152,617) | 9,453,226 | -55.11% | | Net cash used in operating activities | (7,369,388) | (13,365,377) | 5,995,989 | -44.86% | | Net cash used in investing activities | (5,637) | 2,981 | (8,618) | -289.17% | | Net cash from financing activities | 5,322,949 | 3,271,588 | 2,051,361 | 62.70% | | Decrease in cash and cash equivalents | (2,052,076) | (10,090,808) | 8,038,732 | -79.66% | | Cash and cash equivalents at end of period | 4,754,107 | 10,422,835 | (5,668,728) | -54.39% | [Unaudited Notes to the Interim Condensed Consolidated Financial Statements](index=8&type=section&id=Unaudited%20Notes%20to%20the%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [1. General information](index=8&type=section&id=1.%20General%20information) Addex Therapeutics Ltd is a clinical-stage pharmaceutical group focused on CNS disorders, applying an allosteric modulator drug discovery platform. The company is domiciled in Switzerland and its shares are traded on SIX Swiss Exchange (ADXN) and Nasdaq Stock Market (ADXN ADSs) - Addex Therapeutics Ltd is a clinical-stage pharmaceutical group specializing in allosteric modulator drug discovery for central nervous system disorders[23](index=23&type=chunk) - The company's registered shares are traded on the SIX Swiss Exchange (**ADXN**) and its American Depositary Shares (ADSs) are listed on the Nasdaq Stock Market (**ADXN ADSs**)[23](index=23&type=chunk) [2. Basis of preparation](index=8&type=section&id=2.%20Basis%20of%20preparation) These interim condensed consolidated financial statements are prepared under IAS 34 and the historic cost convention, consistent with IAS 1, but do not include all notes required for a complete set of financial statements. They rely on estimates and assumptions, which may differ from actual results, and should be read in conjunction with the 2022 annual financial statements - Interim financial statements are prepared under **IAS 34** and **IAS 1**, using the historic cost convention[25](index=25&type=chunk) - The preparation involves estimates and assumptions that may differ from actual results, and the report should be read with the 2022 consolidated financial statements[26](index=26&type=chunk) - New or amended standards applicable from January 1, 2023, did not have a material impact on the Group's financial position or disclosures[27](index=27&type=chunk) [3. Critical accounting estimates and judgments](index=8&type=section&id=3.%20Critical%20accounting%20estimates%20and%20judgments) The Group's financial statements rely on critical accounting estimates and judgments, particularly regarding its going concern ability, given its reliance on future capital raises. Other key areas include revenue recognition, grants, accrued R&D costs, share-based compensation, and pension obligations, all of which involve significant management judgment and assumptions - Estimates and assumptions are continually evaluated based on historical experience and expectations of future events[28](index=28&type=chunk) [Going concern](index=9&type=section&id=Going%20concern) - The Group's existing cash and cash equivalents are expected to fund operations until **Q1 2024**, raising substantial doubt about its ability to continue as a going concern for one year from the issuance date[31](index=31&type=chunk) - Future viability depends on raising additional capital through financings or collaboration agreements, with no assurance of success, which could lead to delays or cessation of R&D programs[31](index=31&type=chunk) [COVID-19](index=9&type=section&id=COVID-19) - The Group terminated its dipraglurant US registration program in June 2022 due to slow patient recruitment, attributed to COVID-19 related concerns and staffing shortages at study sites[32](index=32&type=chunk) [Russia's invasion of Ukraine](index=9&type=section&id=Russia's%20invasion%20of%20Ukraine) - The conflict poses risks of supply chain disruption for R&D activities and potential adverse impacts on the Group's ability to raise capital[33](index=33&type=chunk) [Revenue recognition](index=9&type=section&id=Revenue%20recognition) - Revenue from licenses, milestones, and research services requires judgment to identify performance obligations, allocate transaction prices, and determine when obligations are met, especially regarding estimated stand-alone selling prices[34](index=34&type=chunk) [Grants](index=9&type=section&id=Grants) - Grants are recorded at fair value when receipt is reasonably assured and recognized as income upon satisfaction of underlying conditions, sometimes before explicit grantor acknowledgment[35](index=35&type=chunk) [Accrued research and development costs](index=9&type=section&id=Accrued%20research%20and%20development%20costs) - Accrued R&D costs for third-party services are based on estimated services provided but not yet invoiced, and these estimates may change with new information[35](index=35&type=chunk) [Research and development costs](index=9&type=section&id=Research%20and%20development%20costs) - R&D expenditure is recognized until future economic benefits are probable, leading to recognition as intangible assets, which involves a degree of judgment[36](index=36&type=chunk) [Share-based compensation](index=10&type=section&id=Share-based%20compensation) - Share-based compensation expense is recognized based on Black-Scholes valuation model, which relies on assumptions about share volatility and risk-free rates; significant variations in these assumptions could materially alter the expense[38](index=38&type=chunk) [Pension obligations](index=10&type=section&id=Pension%20obligations) - The present value of the pension obligations is calculated by an independent actuary using assumptions like discount rates, salary/pension increases, and mortality rates, with changes impacting the carrying amount[39](index=39&type=chunk) [4. Interim measurement note](index=10&type=section&id=4.%20Interim%20measurement%20note) The Group's business is not seasonal, but expenses and revenue are project-phase dependent, particularly external R&D. Costs incurred unevenly are anticipated or deferred in interim reports only if appropriate for year-end financial statements - The business is not subject to seasonality; expenses and revenue are determined by project phase, especially external R&D expenditures[40](index=40&type=chunk) - Unevenly incurred costs are anticipated or deferred in interim reports only if consistent with year-end financial reporting practices[40](index=40&type=chunk) [5. Segment reporting](index=10&type=section&id=5.%20Segment%20reporting) The Group operates as a single segment focused on discovering, developing, and commercializing small-molecule pharmaceutical products. Revenue is primarily from collaborative research funding with Indivior PLC, and operating costs are predominantly incurred in Switzerland - The Group identifies one single operating segment: discovery, development, and commercialization of small-molecule pharmaceutical products[41](index=41&type=chunk) Revenue from Contract with Customer and Other Income by Nature (CHF) | Category | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Collaborative research funding | 327,733 | 409,417 | 1,459,502 | 830,008 | | Other service income | 1,485 | 6,282 | 3,740 | 16,082 | | Total | 329,218 | 415,699 | 1,463,242 | 846,090 | Operating Costs by Geographical Area (CHF) | Geographical Area | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :---------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Switzerland | 2,978,234 | 4,575,915 | 9,051,194 | 17,840,466 | | United States | 2,432 | 5,275 | 7,706 | 23,723 | | France | 1,159 | 1,476 | 3,230 | 3,668 | | Total | 2,981,825 | 4,582,666 | 9,062,130 | 17,867,857 | [6. Cash and cash equivalents](index=11&type=section&id=6.%20Cash%20and%20cash%20equivalents) Cash and cash equivalents decreased by 31.67% to CHF 4.75 million as of September 30, 2023, from CHF 6.96 million at December 31, 2022. The currency composition shifted, with USD holdings increasing significantly while CHF holdings decreased Cash and Cash Equivalents (CHF) | Metric | Sep 30, 2023 | Dec 31, 2022 | | :---------------------- | :----------- | :----------- | | Cash at bank and on hand | 4,754,107 | 6,957,086 | | Total | 4,754,107 | 6,957,086 | Cash and Cash Equivalents by Currency (%) | Currency | Sep 30, 2023 | Dec 31, 2022 | | :------- | :----------- | :----------- | | CHF | 21.29% | 52.98% | | USD | 73.38% | 42.10% | | EUR | 2.57% | 2.69% | | GBP | 2.76% | 2.23% | | Total | 100.00% | 100.00% | - The Group no longer pays interest on CHF cash and cash equivalents from **Q3 2022** but earns interest on USD cash and cash equivalents[47](index=47&type=chunk) [7. Other current assets](index=11&type=section&id=7.%20Other%20current%20assets) Total other current assets increased to CHF 988,600 as of September 30, 2023, from CHF 871,875 at December 31, 2022, primarily due to a significant increase in prepayments, while trade and other receivables decreased Other Current Assets (CHF) | Category | Sep 30, 2023 | Dec 31, 2022 | | :------------------------ | :----------- | :----------- | | Other financial assets | 426 | 3,165 | | Trade and other receivables | 184,266 | 416,875 | | Contract asset (Indivior PLC) | 189,099 | 181,441 | | Prepayments | 614,809 | 270,394 | | Total other current assets | 988,600 | 871,875 | - Prepayments increased by **CHF 0.3 million** due to D&O Insurance premium and retirement benefits paid annually[49](index=49&type=chunk) - The combined amount of contract asset, trade receivables, and other receivables decreased by **CHF 0.2 million**, with a low risk of default and nil expected loss allowance[49](index=49&type=chunk) [8. Right-of-use assets](index=12&type=section&id=8.%20Right-of-use%20assets) Right-of-use assets decreased to CHF 313,465 as of September 30, 2023, from CHF 357,613 at December 31, 2022, reflecting depreciation charges partially offset by the effect of lease modifications Right-of-Use Assets (CHF) | Metric | Sep 30, 2023 | Dec 31, 2022 | | :---------------------- | :----------- | :----------- | | Opening net book amount | 357,613 | 469,989 | | Depreciation charge | (207,390) | (291,573) | | Lease modifications | 163,242 | 179,197 | | Closing net book amount | 313,465 | 357,613 | [9. Property, plant and equipment](index=12&type=section&id=9.%20Property,%20plant%20and%20equipment) Property, plant and equipment decreased to CHF 27,581 as of September 30, 2023, from CHF 41,121 at December 31, 2022, primarily due to depreciation charges, despite minor additions Property, Plant and Equipment (CHF) | Metric | Sep 30, 2023 | Dec 31, 2022 | | :---------------------- | :----------- | :----------- | | Opening net book amount | 41,121 | 72,111 | | Additions | 5,637 | 581 | | Depreciation charge | (19,177) | (31,571) | | Closing net book amount | 27,581 | 41,121 | [10. Non-current financial assets](index=13&type=section&id=10.%20Non-current%20financial%20assets) Non-current financial assets, primarily security rental deposits, remained stable at CHF 54,347 as of September 30, 2023, compared to CHF 54,355 at December 31, 2022 Non-Current Financial Assets (CHF) | Category | Sep 30, 2023 | Dec 31, 2022 | | :----------------------- | :----------- | :----------- | | Security rental deposits | 54,347 | 54,355 | | Total | 54,347 | 54,355 | [11. Payables and accruals](index=13&type=section&id=11.%20Payables%20and%20accruals) Total payables and accruals significantly decreased by CHF 1.3 million to CHF 1,724,580 as of September 30, 2023, from CHF 2,996,004 at December 31, 2022, mainly due to reduced clinical development activities Payables and Accruals (CHF) | Category | Sep 30, 2023 | Dec 31, 2022 | | :---------------------------- | :----------- | :----------- | | Trade payables | 389,781 | 1,276,546 | | Social security and other taxes | 112,515 | 120,875 | | Accrued expenses | 1,222,284 | 1,598,583 | | Total | 1,724,580 | 2,996,004 | - The decrease of **CHF 1.3 million** is primarily due to reduced clinical development activities[55](index=55&type=chunk) - Payables and accruals mainly relate to R&D services from contract research organizations, consultants, and professional fees[55](index=55&type=chunk) [12. Share capital](index=13&type=section&id=12.%20Share%20capital) The outstanding shares increased to 98,369,691 as of September 30, 2023, from 77,134,020 at December 31, 2022, driven by sales under shelf registration, exercise of pre-funded warrants, and sales agency agreements. The company also issued new shares to its subsidiary and engaged in various capital-raising activities Share Capital Movements (Number of Shares) | Metric | Jan 1, 2023 | Sep 30, 2023 | Change | | :-------------------------------------- | :------------ | :------------ | :------------ | | Common shares | 115,348,311 | 142,499,261 | 27,150,950 | | Treasury shares | (38,214,291) | (44,129,570) | (5,915,279) | | Total outstanding shares | 77,134,020 | 98,369,691 | 21,235,671 | - During the nine-month period ended September 30, 2023, the Group sold **3,742,506 treasury shares** under a sale agency agreement for gross proceeds of **CHF 1.18 million**[59](index=59&type=chunk) - On June 14, 2023, the Company issued **17,600,000 new shares** to its subsidiary, Addex Pharma SA, which are held as treasury shares[60](index=60&type=chunk) - On April 3, 2023, the Group sold **7,999,998 treasury shares** and **23,578,950 pre-funded warrant shares** to an institutional investor, generating **USD 5.0 million (CHF 4.5 million)** in gross proceeds[61](index=61&type=chunk) - As of September 30, 2023, **14,028,000 pre-funded warrant shares** remain to be exercised, and **9,550,950 pre-funded warrant shares** were exercised during the period[61](index=61&type=chunk) [13. Share-based compensation](index=14&type=section&id=13.%20Share-based%20compensation) Share-based compensation expense decreased significantly for both the three-month and nine-month periods ended September 30, 2023, compared to the prior year, primarily due to lower fair value of equity incentive units compared to the prior year. The Group granted 13,320,581 new options during the nine-month period Share-Based Compensation Expense (CHF) | Period | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total expense recognized | 483,464 | 897,996 | 1,405,261 | 2,997,307 | - The decrease of **CHF 0.4 million** (3-month) and **CHF 1.6 million** (9-month) is primarily due to the increase in fair value of equity incentive units in the prior year following term modifications[64](index=64&type=chunk) - As of September 30, 2023, **14,097,581 options** were outstanding, with **13,320,581 new options** granted during the nine-month period[66](index=66&type=chunk) - **17,431,572 shares** benefiting from the Deferred Strike Price Payment Plan (DSPPP) were outstanding, recorded as treasury shares under IFRS 2[67](index=67&type=chunk) [14. Retirement benefits obligations](index=15&type=section&id=14.%20Retirement%20benefits%20obligations) The funded status of retirement benefits shifted from a CHF 0.2 million surplus at December 31, 2022, to a CHF 0.1 million shortfall as of September 30, 2023, mainly due to a decrease in the discount rate. The company pension amount decreased for both three-month and nine-month periods Company Pension Amount (CHF) | Period | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Company pension amount | (69,022) | (70,524) | (179,143) | (210,347) | Funded Status of Retirement Benefits (CHF) | Metric | Sep 30, 2023 | Dec 31, 2022 | | :------------------------ | :----------- | :----------- | | Defined benefit obligation | (8,636,535) | (7,682,529) | | Fair value of plan assets | 8,490,767 | 7,867,835 | | Effect of asset ceiling | - | (185,306) | | Funded status shortfall | (145,768) | - | - The decrease in funded status is primarily due to the discount rate decreasing from **2.30% (Dec 31, 2022)** to **1.85% (Sep 30, 2023)**[70](index=70&type=chunk) [15. Revenue from contract with customer](index=15&type=section&id=15.%20Revenue%20from%20contract%20with%20customer) Revenue from contracts with customers primarily stems from the license and research agreement with Indivior PLC, which was extended until June 30, 2024, with additional research funding. No revenue was recognized from the Janssen Pharmaceuticals Inc. agreement during the periods Revenue from Contract with Customer (CHF) | Period | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Revenue recognized | 327,733 | 409,417 | 1,459,502 | 830,008 | [License & research agreement with Indivior PLC](index=15&type=section&id=License%20%26%20research%20agreement%20with%20Indivior%20PLC) - The agreement with Indivior PLC, for GABAB PAM compounds, was extended until **June 30, 2024**, with Indivior committing **CHF 2.7 million** in additional research funding[75](index=75&type=chunk) - The Group recognized **CHF 0.3 million** and **CHF 1.5 million** as revenue for the three-month and nine-month periods ended September 30, 2023, respectively, from this agreement[76](index=76&type=chunk) - Indivior terminated the development of ADX71441 in February 2019 but continues to fund research for novel GABAB PAM compounds[75](index=75&type=chunk) [Janssen Pharmaceuticals Inc. (formerly Ortho-McNeil-Janssen Pharmaceuticals Inc)](index=16&type=section&id=Janssen%20Pharmaceuticals%20Inc.%20(formerly%20Ortho-McNeil-Janssen%20Pharmaceuticals%20Inc)) - No amounts were recognized under the research collaboration and license agreement with Janssen Pharmaceuticals Inc. for mGlu2 PAM compounds during the reported periods[77](index=77&type=chunk) - The Group is eligible for up to **EUR 109 million** in success-based milestones and low double-digit royalties on net sales from this agreement[76](index=76&type=chunk) [16. Other income](index=16&type=section&id=16.%20Other%20income) Other income primarily includes grants from Eurostars/Innosuisse and IT consultancy agreements. The Group was awarded a CHF 0.5 million grant in September 2023 for its mGlu2 NAM program, but no income was recognized in accordance with grant conditions - In September 2023, the Group was awarded a **CHF 0.5 million** grant by Eurostars/Innosuisse for its mGlu2 NAM program, but no income was recognized yet[79](index=79&type=chunk) - Receivables related to Eurostars/Innosuisse grants were nil as of September 30, 2023[79](index=79&type=chunk) - Other income also includes IT consultancy agreements[79](index=79&type=chunk) [17. Operating costs](index=17&type=section&id=17.%20Operating%20costs) Total operating costs significantly decreased by CHF 8.8 million for the nine-month period and CHF 1.6 million for the three-month period ended September 30, 2023, compared to the prior year. This reduction was primarily driven by decreased external research and development activities, lower staff costs, and reduced D&O insurance expenses Operating Costs (CHF) | Category | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Staff costs | 1,322,528 | 1,573,011 | 4,077,916 | 5,118,068 | | External research and development costs | 833,475 | 1,737,712 | 2,294,117 | 8,922,204 | | D&O Insurance | 157,399 | 397,753 | 472,311 | 1,193,441 | | Total operating costs | 2,981,825 | 4,582,666 | 9,062,130 | 17,867,857 | - Total operating costs decreased by **CHF 8.8 million** for the nine-month period, mainly due to a **CHF 6.6 million** decrease in dipraglurant-related external R&D activities[81](index=81&type=chunk) - Staff costs decreased by **CHF 1.0 million** (9-month) and **CHF 0.3 million** (3-month) primarily due to lower share-based service costs[81](index=81&type=chunk) - D&O insurance decreased by **CHF 0.7 million** (9-month) and **CHF 0.2 million** (3-month)[81](index=81&type=chunk) [18. Staff costs](index=17&type=section&id=18.%20Staff%20costs) Total staff costs decreased by CHF 1.0 million for the nine-month period ended September 30, 2023, compared to the same period in 2022, primarily driven by lower share-based service costs Staff Costs (CHF) | Category | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :------------------------ | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Wages and salaries | 758,231 | 680,231 | 2,427,921 | 2,193,349 | | Social charges and insurances | 85,589 | 79,287 | 280,322 | 258,733 | | Value of share-based services | 409,686 | 742,969 | 1,190,530 | 2,455,639 | | Retirement benefit | 69,022 | 70,524 | 179,143 | 210,347 | | Total staff costs | 1,322,528 | 1,573,011 | 4,077,916 | 5,118,068 | - The **CHF 1.0 million** decrease in total staff costs for the nine-month period is primarily due to lower share-based service costs[82](index=82&type=chunk) [19. Finance result, net](index=17&type=section&id=19.%20Finance%20result,%20net) The net finance result for the nine-month period ended September 30, 2023, was a loss of CHF 100,503, an improvement from the CHF 130,850 loss in the prior year, driven by increased interest income and reduced interest costs, despite foreign exchange losses Finance Result, Net (CHF) | Category | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Interest income | 13,658 | 3,605 | 50,833 | 3,904 | | Interest cost | - | (1,509) | (93) | (25,878) | | Interest expense on leases | (3,503) | (4,875) | (13,158) | (15,252) | | Foreign exchange (losses)/gains, net | 25,382 | 62,116 | (138,085) | (93,624) | | Finance result, net | 35,537 | 59,337 | (100,503) | (130,850) | [20. Loss per share](index=18&type=section&id=20.%20Loss%20per%20share) Basic and diluted loss per share significantly improved for both the three-month and nine-month periods ended September 30, 2023, reflecting a reduced net loss and an increased weighted average number of shares in issue Loss Per Share (CHF) | Metric | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Loss attributable to equity holders | (2,617,070) | (4,107,630) | (7,699,391) | (17,152,617) | | Weighted average number of shares in issue | 77,278,532 | 47,785,707 | 70,299,213 | 41,238,494 | | Basic and diluted loss per share | (0.03) | (0.09) | (0.11) | (0.42) | - Dilutive potential shares (treasury shares, ESCs, share options, and warrants) were ignored as they would be antidilutive[86](index=86&type=chunk) [21. Related party transactions](index=18&type=section&id=21.%20Related%20party%20transactions) Key management compensation, including salaries, benefits, consulting fees, and share-based compensation, decreased for both the three-month and nine-month periods ended September 30, 2023, compared to the prior year, primarily due to a reduction in share-based compensation Key Management Compensation (CHF) | Category | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :---------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Salaries, other short-term employee benefits and post-employment benefits | 356,505 | 348,262 | 1,284,010 | 1,270,926 | | Consulting fees | 3,889 | 20,403 | 13,614 | 144,110 | | Share-based compensation | 416,890 | 781,638 | 1,200,430 | 2,603,742 | | Total | 777,284 | 1,150,303 | 2,498,054 | 4,018,778 | - The decrease in total compensation is mainly attributable to lower share-based compensation[88](index=88&type=chunk) [22. Events after the balance sheet date](index=18&type=section&id=22.%20Events%20after%20the%20balance%20sheet%20date) Post-balance sheet events include an ADS ratio change (1-for-20 reverse split effect) to regain Nasdaq compliance, which was confirmed in November 2023. The company also sold treasury shares and issued new shares from exercised pre-funded warrants and an employee/director retention plan, with some new shares subject to sales restrictions - On October 23, 2023, the ADS ratio changed from one ADS to six shares to one ADS to one hundred and twenty shares, effectively a **1-for-20 ADS reverse split**, to regain Nasdaq minimum bid price compliance[89](index=89&type=chunk) - Nasdaq confirmed compliance was regained on **November 8, 2023**[89](index=89&type=chunk) - In October 2023, **263,867 treasury shares** were sold, and in November 2023, **7,908,000 shares** were issued from exercised pre-funded warrants[89](index=89&type=chunk)[90](index=90&type=chunk) - On November 27, 2023, **12,527,235 equity incentive units** were exercised as part of an employee and director retention plan, resulting in new share issuance, with **10,961,330 shares** subject to sales restrictions[90](index=90&type=chunk)
Addex Therapeutics(ADXN) - 2023 Q2 - Earnings Call Transcript
2023-08-11 01:48
Financial Data and Key Metrics Changes - The company recognized CHF0.6 million of income in Q2 2023 compared to CHF0.2 million in Q2 2022, with the primary source being research funding from Indivior [31] - R&D expenses decreased significantly to CHF1.9 million in Q2 2023 from CHF5.8 million in Q2 2022, primarily due to the termination of the PD-LID development [31] - G&A expenses were CHF1.3 million in Q2 2023, down from CHF1.5 million in Q2 2022, driven by reduced D&O insurance costs [31] - The company completed Q2 2023 with CHF7.2 million in cash, indicating a monthly cash burn of well under CHF1 million [44] Business Line Data and Key Metrics Changes - The ADX71149 epilepsy study is progressing well, with Cohort 1 completed and Cohort 2 actively recruiting patients [4][9] - The collaboration with Indivior has received an additional CHF2.7 million in funding, bringing the total to CHF13.8 million, supporting multiple drug candidates [20][40] Market Data and Key Metrics Changes - The epilepsy market is described as a multibillion-dollar opportunity, with significant unmet needs despite existing treatments [11] - There are over 100 million stroke survivors worldwide, with a growing annual rate of 5.7 million, indicating a large market for post-stroke recovery treatments [17] Company Strategy and Development Direction - The company is focusing on advancing its pipeline, particularly in post-stroke recovery and stress-related disorders, while pursuing partnerships for future development [5][17] - The M4 PAM program for schizophrenia is now a priority, with progress towards clinical candidate selection [7][24] Management's Comments on Operating Environment and Future Outlook - Management acknowledged disappointing stock performance but expressed optimism about ongoing business discussions and potential partnerships that could enhance stock value [33] - The company is guiding that cash reserves will last into 2024, with potential for extension through further cost-cutting measures [44] Other Important Information - The company has made substantial progress in its preclinical pipeline, with multiple candidates advancing towards IND-enabling studies [30] - Significant intellectual property protections are in place for all programs, supporting the company's drug discovery efforts [33] Q&A Session Summary Question: When will top line data from the epilepsy trials be released? - Management indicated that completion is expected by April 2024, but specific data release dates depend on Janssen's progress [36][38] Question: Will a candidate from the Indivior collaboration advance into the clinic? - Management confirmed that multiple drug candidates are being profiled, with a selection expected by the end of the year or early next year [39][40] Question: Any updates on unlocking value from dipraglurant? - Management is evaluating dipraglurant for post-stroke recovery and is in discussions with potential partners for various indications [41][42] Question: What is the cash runway guidance? - Management stated that cash reserves are expected to last into 2024, with ongoing efforts to reduce cash burn [43][44]