Addex Therapeutics(ADXN) - 2022 Q4 - Annual Report

Key 2022 Financial Data Addex Therapeutics reported a widened net loss and a significant decrease in cash and equity in 2022 Financial Summary Table 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] Detailed Financial Analysis 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 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][5] - 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] - 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] - 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] Cash and Equity Position 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][6] - 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] - 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] 2022 Operating Highlights Addex Therapeutics advanced its clinical and preclinical pipeline, pursued strategic partnerships, and implemented financial initiatives in 2022 Clinical Development Progress 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] - Dipraglurant is Phase 2 ready, with future development in PD-LID, post-stroke recovery, and pain under evaluation[3] Preclinical Pipeline & Strategic Partnerships 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] - GABAB PAM strategic partnership with Indivior for substance use disorders extended, with multiple drug candidates in clinical candidate selection phase[3] - GABAB PAM CMT1A, chronic cough and pain program profiling multiple drug candidates[3] - Continued to progress with mGlu2 NAM mild neurocognitive disorders program and M4 PAM schizophrenia program through lead optimization[3] Corporate & Financial Initiatives 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] - Completed the close-down of dipraglurant PD-LID development and implemented cost-saving measures[3] - Completed offering in July 2022, raising gross proceeds of $4.2 million[3] Corporate Overview and Disclosures This section provides an overview of Addex Therapeutics' 2022 financial results, corporate updates, company profile, and important disclosures Corporate Announcement and CEO Statement 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] - 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] About Addex Therapeutics 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] - 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] - Addex's second clinical program, dipraglurant (mGlu5 NAM), is under evaluation for future development in a range of indications[10] - Indivior PLC has licensed Addex's GABAB PAM program for the development of drug candidates, with a focus on substance use disorder[10] - 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] Conference Call Details 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] - 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] - Participants were required to register in advance using a provided link, which would then provide dial-in numbers and a unique Personal PIN[8][9] Press Contacts 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 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] - 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] - Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements[13]