[Key 2022 Financial Data](index=1&type=section&id=Key%202022%20Financial%20Data) Addex Therapeutics reported a widened net loss and a significant decrease in cash and equity in 2022 [Financial Summary Table](index=1&type=section&id=1.1_Financial%20Summary%20Table) Addex Therapeutics reported a net loss of CHF 20.8 million in 2022, an increase from CHF 15.4 million in 2021. Cash and cash equivalents significantly decreased to CHF 7.0 million from CHF 20.5 million, reflecting increased operating losses and a decrease in net cash 2022 vs 2021 Financial Summary (CHF thousands) | Metric | 2022 | 2021 | Change | | :----- | :--- | :--- | :----- | | Income | 1,445 | 3,153 | (1,708) | | R&D expenses | (14,665) | (12,840) | (1,825) | | G&A expenses | (7,300) | (5,819) | (1,481) | | Total operating loss | (20,520) | (15,506) | (5,014) | | Finance result, net | (284) | 154 | (438) | | Net loss for the period | (20,804) | (15,352) | (5,452) | | Basic and diluted net loss per share | (0.46) | (0.45) | (0.01) | | Net increase / (decrease) in cash and cash equivalents | (13,528) | 1,790 | (15,318) | | Cash and cash equivalents | 6,957 | 20,485 | (13,528) | | Shareholders' equity | 4,913 | 16,931 | (12,018) | - Cash and cash equivalents at December 31, 2022, were **CHF 7.0 million ($7.4 million)**[1](index=1&type=chunk) [Detailed Financial Analysis](index=1&type=section&id=1.2_Detailed%20Financial%20Analysis) Addex Therapeutics experienced a decrease in income due to the advanced stage of its Indivior collaboration, while both R&D and G&A expenses increased, primarily driven by outsourced activities and higher share-based compensation costs, leading to a widened net loss and a significant reduction in cash and cash equivalents [Income Statement Components](index=1&type=section&id=1.2.1_Income%20Statement%20Components) Income decreased due to collaboration progression, while R&D and G&A expenses rose, leading to a higher net loss - Income decreased by **CHF 1.7 million** to **CHF 1.4 million** in 2022 (from CHF 3.2 million in 2021), primarily due to the positive progression of the Indivior collaboration into late stages of clinical candidate selection and the transfer of R&D activities to Indivior[4](index=4&type=chunk)[5](index=5&type=chunk) - R&D expenses increased by **CHF 1.8 million** to **CHF 14.6 million** in 2022 (from CHF 12.8 million in 2021), mainly due to increased outsourced R&D expenses (**CHF 1.0 million**) and increased share-based compensation costs (**CHF 0.6 million**)[5](index=5&type=chunk) - G&A expenses increased by **CHF 1.5 million** to **CHF 7.3 million** in 2022 (from CHF 5.8 million in 2021), primarily due to higher share-based compensation costs[5](index=5&type=chunk) - Net loss increased by **CHF 5.5 million** to **CHF 20.8 million** in 2022 (from CHF 15.4 million in 2021), primarily due to increased expenses and decreased income. Basic and diluted loss per share increased to **CHF 0.46** (from CHF 0.45)[5](index=5&type=chunk) [Cash and Equity Position](index=2&type=section&id=1.2.2_Cash%20and%20Equity%20Position) Cash and cash equivalents significantly decreased, primarily due to net loss, despite proceeds from a July 2022 offering - Cash and cash equivalents decreased by **CHF 13.5 million** to **CHF 7.0 million** at December 31, 2022 (from CHF 20.5 million at December 31, 2021)[1](index=1&type=chunk)[6](index=6&type=chunk) - The decrease in cash was mainly due to the net loss of **CHF 20.8 million**, adjusted for non-cash expense items such as share-based compensation of **CHF 3.7 million** and net proceeds of **CHF 3.7 million** from the offering executed on July 22, 2022[6](index=6&type=chunk) - Shareholders' equity decreased by **CHF 12.0 million** to **CHF 4.9 million** at December 31, 2022 (from CHF 16.9 million at December 31, 2021)[1](index=1&type=chunk) [2022 Operating Highlights](index=1&type=section&id=2022%20Operating%20Highlights) Addex Therapeutics advanced its clinical and preclinical pipeline, pursued strategic partnerships, and implemented financial initiatives in 2022 [Clinical Development Progress](index=1&type=section&id=2.1_Clinical%20Development%20Progress) Addex made significant strides in its clinical programs, with ADX71149 completing part 1 of its Phase 2 epilepsy study and Dipraglurant being Phase 2 ready for potential development in PD-LID, post-stroke recovery, and pain - ADX71149 epilepsy Phase 2 study part 1 completed with Independent interim review committee recommendation expected early Q2 2023[3](index=3&type=chunk) - Dipraglurant is Phase 2 ready, with future development in PD-LID, post-stroke recovery, and pain under evaluation[3](index=3&type=chunk) [Preclinical Pipeline & Strategic Partnerships](index=1&type=section&id=2.2_Preclinical%20Pipeline%20%26%20Strategic%20Partnerships) The preclinical pipeline advanced with a drug candidate selected for IND-enabling studies for mGlu7 NAM in stress-related disorders, and multiple drug candidates in the clinical candidate selection phase for the GABAB PAM program, which has an extended strategic partnership with Indivior - mGlu7 NAM for stress-related disorders, including PTSD: drug candidate selected for IND enabling studies, with study preparation underway[3](index=3&type=chunk) - GABAB PAM strategic partnership with Indivior for substance use disorders extended, with multiple drug candidates in clinical candidate selection phase[3](index=3&type=chunk) - GABAB PAM CMT1A, chronic cough and pain program profiling multiple drug candidates[3](index=3&type=chunk) - Continued to progress with mGlu2 NAM mild neurocognitive disorders program and M4 PAM schizophrenia program through lead optimization[3](index=3&type=chunk) [Corporate & Financial Initiatives](index=1&type=section&id=2.3_Corporate%20%26%20Financial%20Initiatives) Addex actively pursued partnering discussions across its portfolio, completed the close-down of dipraglurant PD-LID development, implemented cost-saving measures, and successfully raised gross proceeds of $4.2 million through an offering in July 2022 - Partnering discussions across the portfolio progressing well[3](index=3&type=chunk) - Completed the close-down of dipraglurant PD-LID development and implemented cost-saving measures[3](index=3&type=chunk) - Completed offering in July 2022, raising gross proceeds of **$4.2 million**[3](index=3&type=chunk) [Corporate Overview and Disclosures](index=1&type=section&id=Corporate%20Overview%20and%20Disclosures) This section provides an overview of Addex Therapeutics' 2022 financial results, corporate updates, company profile, and important disclosures [Corporate Announcement and CEO Statement](index=1&type=section&id=3.1_Corporate%20Announcement%20and%20CEO%20Statement) Addex Therapeutics announced its full-year 2022 financial results and corporate update, with CEO Tim Dyer highlighting progress in the ADX71149 Phase 2 study and the company's continued focus on securing financial resources through collaborative arrangements - Addex Therapeutics, a clinical-stage pharmaceutical company, reported financial results for the full-year ended December 31, 2022, and provided a corporate update[2](index=2&type=chunk) - CEO Tim Dyer noted excellent progress in the ADX71149 Phase 2 clinical study and a continued focus on pursuing collaborative arrangements to secure financial resources and strengthen the balance sheet[2](index=2&type=chunk) [About Addex Therapeutics](index=2&type=section&id=3.2_About%20Addex%20Therapeutics) Addex Therapeutics is a clinical-stage pharmaceutical company specializing in orally available, small molecule allosteric modulators for neurological disorders. Its lead candidate, ADX71149, is in Phase 2a for epilepsy, and it has a broad preclinical pipeline and partnerships for various indications - Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of novel orally available, small molecule allosteric modulators for neurological disorders[10](index=10&type=chunk) - Lead drug candidate, ADX71149 (mGlu2 PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2a proof of concept clinical trial for epilepsy[10](index=10&type=chunk) - Addex's second clinical program, dipraglurant (mGlu5 NAM), is under evaluation for future development in a range of indications[10](index=10&type=chunk) - Indivior PLC has licensed Addex's GABAB PAM program for the development of drug candidates, with a focus on substance use disorder[10](index=10&type=chunk) - Addex is also advancing a broad preclinical pipeline, including GABAB PAMs for CMT1A, chronic cough and pain; mGlu7 NAM for stress-related disorders; mGlu2 NAM for mild neurocognitive disorders and depression; M4 PAM for schizophrenia; and mGlu4 PAM and mGlu3 PAM[10](index=10&type=chunk) [Conference Call Details](index=2&type=section&id=3.3_Conference%20Call%20Details) A conference call was scheduled for March 30, 2023, at 16:00 CEST to review the financial results, featuring CEO Tim Dyer and Head of Discovery - Biology Robert Lütjens, followed by a Q&A session. Participants were required to register in advance - A conference call was held on March 30, 2023, at 16:00 CEST to review the financial results[7](index=7&type=chunk) - Tim Dyer (Chief Executive Officer) and Robert Lütjens (Head of Discovery - Biology) were scheduled to deliver a presentation followed by a Q&A session[7](index=7&type=chunk) - Participants were required to register in advance using a provided link, which would then provide dial-in numbers and a unique Personal PIN[8](index=8&type=chunk)[9](index=9&type=chunk) [Press Contacts](index=3&type=section&id=3.4_Press%20Contacts) Contact information for media inquiries is provided, including Tim Dyer (CEO) and Mike Sinclair (Partner, Halsin Partners) Press Contacts | Name | Title/Company | Contact Information | | :--- | :------------ | :------------------ | | 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 | [Forward Looking Statements](index=3&type=section&id=3.5_Forward%20Looking%20Statements) This section contains standard forward-looking statements regarding clinical trial progress, collaboration outcomes, and strategic direction, emphasizing that actual results may differ due to various risks and uncertainties detailed in SEC filings. The company explicitly disclaims any obligation to update these statements - This press release contains forward-looking statements regarding the ability to discover molecules, progress of clinical trials and preclinical studies, timing of data read-outs, and intended strategic direction[13](index=13&type=chunk) - These statements are based on management's current expectations and beliefs and are subject to risks, uncertainties, and important factors that may cause actual events or results to differ materially, as described in Addex Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2022, and other SEC filings[13](index=13&type=chunk) - Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements[13](index=13&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

Financial Data and Key Metrics Changes - The company recognized CHF0.4 million of income in Q3 2022, a decrease from CHF0.8 million in Q3 2021, primarily due to reduced research funding from collaboration with Indivior [27] - R&D expenses were CHF2.8 million in Q3 2022, slightly down from CHF2.9 million in Q3 2021, attributed to reduced dipraglurant development activities [28] - G&A expenses increased to CHF1.8 million in Q3 2022 from CHF1.5 million in Q3 2021, mainly due to higher share-based compensation costs [28] - The company completed Q3 2022 with cash reserves of CHF10.4 million, providing a cash runway through Q2 2023 [5][29] Business Line Data and Key Metrics Changes - The GABAB PAM program is progressing towards late clinical candidate selection, with multiple candidates being profiled [4][17] - The mGluR7 negative allosteric modulator program has selected a clinical candidate ready to enter IND-enabling studies [22] - The mGluR2 NAM program is in the clinical candidate selection phase, with plans to start IND-enabling studies in the second half of 2023 [24] Market Data and Key Metrics Changes - The epilepsy market remains a significant opportunity, with the anti-epileptic market estimated at close to $20 billion in sales revenue [8] - The company’s partner, Janssen Pharmaceuticals, is on track to complete Part 1 of the Phase 2 epilepsy clinical study, with results expected in Q1 2023 [29] Company Strategy and Development Direction - The company aims to develop independent programs in Charcot-Marie-Tooth 1A neuropathy, chronic cough, and pain, alongside its partnered programs [4][18][20] - The focus on allosteric modulation is expected to yield differentiated drug candidates with improved efficacy and safety profiles compared to existing treatments [17][25] Management's Comments on Operating Environment and Future Outlook - Management expressed moderate confidence in closing a partnership deal by mid-next year, emphasizing the importance of securing a partner for restarting development activities [33] - The company recognizes its disappointing stock performance but believes successful execution of its partnering strategy will enhance stock value [30] Other Important Information - The company has retained rights to select drug candidates from the Indivior-funded research activities for its independent GABAB PAM program [4][17] - The company is pursuing multiple business discussions related to dipraglurant for various indications and plans to restart development once a partner is secured [14][29] Q&A Session Summary Question: Can you provide more details on your BD efforts and the timeline for closing a deal? - Management stated that discussions are ongoing with multiple potential partners for dipraglurant and expressed moderate confidence in closing a deal by mid-next year [33] Question: What is the main goal of Part 1 of the epilepsy study and what follows after? - The goal of Part 1 is to evaluate the difference in time to baseline seizure counts between the active group and placebo group, with results expected in Q1 2023 [35]

Addex Therapeutics Ltd (NASDAQ:ADXN) Q2 2022 Earnings Conference Call August 18, 2022 10:00 AM ET Company Participants Tim Dyer - Co-Founder, Board Director and CEO Roger Mills - Chief Medical Officer Robert Lütjens - Head of Discovery, Biology Conference Call Participants Raghuram Selvaraju - HC Wainwright Bob Pooler - valuationLAB AG Operator Good day and thank you for standing by. Welcome to the Addex Therapeutics to Announce Half Year 2022 Financial Results and provide Corporate Update Conference Call. ...

Financial Data and Key Metrics Changes - In 2021, the company recognized $3.2 million in revenue, an increase from $2.9 million in 2020, primarily from research funding with Indivior [23] - R&D expenses rose to $12.8 million, up by $2.5 million compared to 2020, due to increased activities in the Dipraglurant and GABAB PAM programs [23] - G&A expenses were $5.8 million, slightly up from $5.7 million in 2020, attributed to higher insurance premiums [24] - The company ended the year with a cash position of CHF20.5 million, equivalent to $22.5 million [6][25] Business Line Data and Key Metrics Changes - The company has three clinical programs actively dosing patients, including Dipraglurant for blepharospasm and dyskinesia associated with Parkinson's Disease [3][26] - The pivotal Phase 2b/3 study for Dipraglurant in PD-LID began in Q2 2021, enrolling 140 patients [7] - The exploratory study for blepharospasm involves 15 patients and is expected to report data in Q2 2022 [12] Market Data and Key Metrics Changes - The market opportunity for Dipraglurant in dyskinesia associated with Parkinson's Disease is described as multi-billion dollars [7] - There are approximately 50,000 patients in the U.S. suffering from blepharospasm, with about 2,000 new cases annually [51] Company Strategy and Development Direction - The company aims to maintain the integrity and quality of its clinical studies despite delays caused by the pandemic [4] - A strategic collaboration with Indivior was extended, with an additional $4 million committed for research funding [5] - The company is focused on advancing multiple preclinical programs, including mGlu7 NAM for PTSD and mGlu2 NAM for mild neurocognitive disorders [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for significant data readouts in 2022 [27] - The company anticipates a promising outlook, highlighting the undervalued equity story and the potential for partnerships as clinical data emerges [27] Other Important Information - The company has made significant progress in its preclinical portfolio, with multiple drug candidates advancing towards IND-enabling studies [22] - The company is exploring non-dilutive funding opportunities for its PTSD program, which has garnered interest from governmental entities [43] Q&A Session Summary Question: Is enrollment for the PD-LID Dipraglurant study hastening as the Omicron wave recedes? - Management noted good momentum in enrollment as COVID impacts lessen, with encouraging activity across various sites [30] Question: What is the strategic positioning for Dipraglurant regarding different indications? - Management indicated that data from the blepharospasm study will inform future development strategies, with a focus on a strong signal from the exploratory study [35] Question: What is the timing for Indivior's decision on extending the collaboration? - The collaboration is currently under review, with discussions expected as the program reaches advanced stages of clinical candidate selection [42] Question: Can you provide guidance on cash burn and cash reach? - The company reported a cash burn of approximately CHF1.5 million per month, guiding cash availability into the first half of 2023 [46] Question: What is the market potential for the blepharospasm indication? - The company estimates around 50,000 patients in the U.S. with blepharospasm, highlighting the impactful nature of the condition [51] Question: When can we expect lead candidates in clinical trials for the GABAB PAM program? - The company anticipates moving candidates into IND-enabling studies by the end of 2022, with Phase 1 trials potentially starting in late 2023 [55] Question: Will positive results from the ADX71149 epilepsy study trigger a milestone payment? - Management clarified that the last milestone was received when the program entered Phase 2, and no further details on future milestones could be provided [58][59]

Financial Performance - Cash and cash equivalents increased to CHF 20.5 million at December 31, 2021, up from CHF 18.7 million at the end of 2020, representing an increase of CHF 1.8 million[9] - Total operating loss for 2021 was CHF 15.5 million, compared to CHF 12.2 million in 2020, reflecting an increase in R&D expenses[5] - Income decreased by CHF 0.7 million to CHF 3.2 million in 2021, down from CHF 3.9 million in 2020[7] - The net loss for the period was CHF 15.4 million in 2021, compared to CHF 12.9 million in 2020, with basic and diluted loss per share decreasing to CHF 0.45 from CHF 0.48[9] Research and Development - R&D expenses rose by CHF 2.4 million to CHF 12.8 million in 2021, primarily due to increased outsourced R&D costs[8] - The Phase 2 clinical trial for dipraglurant in blepharospasm is on track to report data in Q2 2022[3] - The Phase 2b/3 study for dipraglurant in dyskinesia associated with Parkinson's disease is expected to report data in H1 2023[3] - The Phase 2a clinical study of ADX71149 in epilepsy is on track to report data in Q3 2022[3] Strategic Collaborations and Funding - A strategic collaboration with Indivior was extended with an additional funding of $4 million[2] - The company completed the year with a strong cash position of $22.5 million, bolstered by a $10 million financing from Armistice Capital[2]