Addex Therapeutics(ADXN)
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Addex Therapeutics(ADXN) - 2023 Q2 - Quarterly Report
2023-08-09 16:00
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 June 30, 2023 and December 31, 2022 2 Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss for the three-month and six-month periods ended 3 June 30, 2023 and 2022 Unaudited Interim Condensed Consolidated Statements of Changes in Equity for the six-month perio ...
Addex Therapeutics(ADXN) - 2023 Q1 - Earnings Call Transcript
2023-05-12 22:39
Addex Therapeutics Ltd. (NASDAQ:ADXN) Q1 2023 Earnings Conference Call May 11, 2023 10:00 AM ET Company Participants Timothy Dyer – Chief Executive Officer Robert Lütjens – Head of Discovery-Biology Conference Call Participants Boobalan Pachaiyappan – H.C. Wainwright Leonildo Delgado – Baader Helvea Timothy Dyer Hello, everyone. I would like to thank you all for attending our First Quarter 2023 Financial Results Conference Call. I'm here with Robert Lütjens, our Head of Discovery Biology. I draw your attent ...
Addex Therapeutics(ADXN) - 2023 Q1 - Quarterly Report
2023-05-10 16:00
Financial Performance - Revenue from contracts with customers increased to CHF 500,892 for the three months ended March 31, 2023, compared to CHF 237,237 for the same period in 2022, marking a growth of approximately 111%[7] - Total revenue for Q1 2023 was CHF 502,047, up from CHF 243,948 in Q1 2022, marking a 106% increase[39] - Net loss for the period narrowed to CHF 2,407,169 in Q1 2023 from CHF 5,823,735 in Q1 2022, indicating an improvement of approximately 59%[7] - The loss attributable to equity holders for Q1 2023 was CHF 2,407,169, an improvement from 5,823,735 in Q1 2022[83] - Basic and diluted loss per share improved to CHF (0.04) in Q1 2023 from CHF (0.15) in Q1 2022[7] Operating Costs - Total operating costs decreased from CHF 6,006,533 in Q1 2022 to CHF 2,901,552 in Q1 2023, a reduction of approximately 52%[7] - Total operating costs for Q1 2023 decreased to CHF 2,901,552, down CHF 3.1 million from CHF 6,006,533 in Q1 2022, primarily due to reduced external research and development expenses[76][77] - General and administration expenses decreased from CHF 2,241,086 in Q1 2022 to CHF 1,197,577 in Q1 2023, a decline of approximately 47%[7] - Research and development expenses were CHF 1,703,975 in Q1 2023, down from CHF 3,765,447 in Q1 2022, a reduction of approximately 55%[7] - Total staff costs for Q1 2023 were CHF 1,343,428, a decrease of CHF 0.8 million compared to CHF 2,192,973 in Q1 2022, mainly due to lower share-based service costs[80] Cash and Assets - Total assets decreased from CHF 8,282,050 as of December 31, 2022, to CHF 7,294,522 as of March 31, 2023, representing a decline of approximately 12%[4] - Cash and cash equivalents decreased from CHF 6,957,086 as of December 31, 2022, to CHF 5,594,872 as of March 31, 2023, a decline of approximately 20%[4] - Cash and cash equivalents at the end of the period were CHF 5,594,872, down from CHF 14,887,838 at the end of the same period in 2022, reflecting a decrease of 62.4%[18] - Other current assets increased to CHF 1,319,871 as of March 31, 2023, compared to CHF 871,875 as of December 31, 2022, an increase of 51%[45] - Total equity decreased from CHF 4,912,911 as of December 31, 2022, to CHF 4,071,228 as of March 31, 2023, a decrease of approximately 17%[4] Cash Flow and Financing - Net cash used in operating activities decreased to CHF 2,359,437 from CHF 4,844,624, indicating a 51.3% reduction in cash outflow[18] - The Group's cash flows from financing activities resulted in a net cash inflow of CHF 1,028,343, contrasting with a net cash outflow of CHF 744,352 in the prior year[18] - The Group's existing cash and cash equivalents are expected to be insufficient to fund operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern[27] - The Group is exploring options to obtain additional funding through collaborations and public or private financings to support future operations[27] Shareholder Information - The total number of shares outstanding as of March 31, 2023, was 80,871,291, excluding 34,477,020 treasury shares[56] - The Group sold 3,742,506 treasury shares at an average price of CHF 0.31 per share, generating gross proceeds of CHF 1,176,781 during Q1 2023[57] - Total share-based compensation expense for Q1 2023 was CHF 431,196, a decrease of CHF 1.0 million from CHF 1,440,052 in Q1 2022[13] - The Group's share-based compensation expense was CHF 431,196 for the period, down from CHF 1,440,052 in the same period last year, indicating a 70% decrease[18] Revenue Recognition - The Group's revenue primarily comes from fees related to licenses, milestones, and research services, with significant judgment required in revenue recognition[30] - Collaborative research funding revenue increased to CHF 500,892 in Q1 2023 from CHF 237,237 in Q1 2022, representing a growth of 111%[37] - Other service income decreased to CHF 1,155 in Q1 2023 from CHF 6,711 in Q1 2022, a decline of 83%[37]
Addex Therapeutics(ADXN) - 2022 Q4 - Earnings Call Transcript
2023-03-31 21:55
Financial Data and Key Metrics Changes - The company recognized $1.4 million of income in 2022, a decrease from $3.2 million in 2021, primarily due to reduced research funding from collaboration with Indivior [26] - R&D expenses increased to $14.7 million in 2022 from $12.8 million in 2021, attributed to increased outsourced clinical activities and share-based compensation [26] - G&A expenses rose to $7.3 million in 2022 from $5.8 million in 2021, mainly due to increased share-based compensation costs [27] - The company ended 2022 with CHF 7 million in cash, down from $20.5 million at the start of the year, after consuming $17.6 million in operations [28] Business Line Data and Key Metrics Changes - The collaboration with Indivior was extended, with an additional research funding of $1.8 million expected [5] - The mGlu2 NAM program faced challenges during the clinical candidate selection phase, leading to a return to lead optimization [5] - The M4 PAM program for schizophrenia is progressing rapidly through lead optimization, especially following positive Phase III data from a competitor [5][6] Market Data and Key Metrics Changes - The market opportunity for ADX71149 in epilepsy is significant, with over 2 million patients on Keppra, which generates close to $1 billion in annual sales [7][8] - The company has retained significant economic rights in its deal with Janssen, including prelaunch milestones of EUR 109 million and low double-digit royalties on net sales [8] Company Strategy and Development Direction - The company is focusing on advancing its preclinical pipeline, with multiple candidates moving towards IND-enabling studies [25] - Future development plans for dipraglurant include exploring indications in post-stroke recovery and pain management [29] - The company aims to secure partnerships to strengthen its balance sheet and advance its portfolio [30] Management's Comments on Operating Environment and Future Outlook - Management acknowledged disappointing stock performance and market capitalization but expressed optimism about ongoing business discussions and potential partnerships [30] - The company is evaluating the future development of dipraglurant and believes in its value for treating PD-LID and other indications [29] Other Important Information - The company implemented cost-saving measures that significantly reduced monthly cash burn, providing a runway through the end of Q3 2023 [6] - The independent interim review committee established by Janssen will provide recommendations on the ADX71149 study in early Q2 2023 [11][28] Q&A Session Summary Question: What might Janssen consider an unexpectedly positive outcome from the epilepsy proof-of-concept study? - Management explained that Janssen is looking for a go/no-go decision based on how many patients reached their baseline seizure count in Part 1 of the study [32][33] Question: How does the M4 allosteric modulator compare to xanomeline plus trospium? - Management highlighted that their approach uses a selective positive allosteric modulator, which may avoid tolerance issues seen with agonists [35][36] Question: Why has the compensation for the Board and executives increased significantly? - The increase is linked to a reorganization of the share-based compensation program, driven by IFRS 2 calculations [40][41] Question: Why are IND-enabling studies for GABAB not happening earlier? - Management noted that Indivior is conducting thorough profiling of compounds, which has delayed the selection process [44][45] Question: Are patients being recruited for the second part of the ADX71149 study? - Management confirmed that recruitment is ongoing and that patients from Part 1 who did not meet their baseline seizure count have rolled over into Part 2 [47][49]
Addex Therapeutics(ADXN) - 2022 Q4 - Annual Report
2023-03-29 16:00
[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)
Addex Therapeutics(ADXN) - 2022 Q4 - Annual Report
2023-03-29 16:00
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 ...
Addex Therapeutics(ADXN) - 2022 Q3 - Earnings Call Transcript
2022-11-11 19:36
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(ADXN) - 2022 Q2 - Earnings Call Transcript
2022-08-18 19:50
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. ...