ADXN — Addex Therapeutics Ltd

Summary of ADXN Q3 2025 Earnings Call

1. Key Financial Results and Metrics

• Income: CHF 0.1 million, consistent with Q3 2024, primarily from patent maintenance funded by Indivior.
• R&D Expenses: CHF 0.2 million, stable compared to Q3 2024, focused on the GABAB PAM program.
• G&A Expenses: CHF 0.5 million, unchanged from the prior year.
• Net Loss from Neurosterix: CHF 0.9 million, similar to Q3 2024.
• Cash Position: CHF 2.2 million, providing a runway through mid-2026. Current cash levels do not support unpartnered programs progressing to clinical stages.

2. Strategic Updates and Business Highlights

• GABAB PAM Program: Significant progress in preclinical characterization and selection of a backup compound. IND-enabling studies are ready to commence pending financing.
• Dipraglurant: Repositioned for post-stroke recovery, with preparations for clinical studies ongoing. Collaboration with Sinntaxis and the University of Lund is in place for preclinical profiling.
• Neurosterix: Advancing its portfolio, including an M4 PAM program expected to enter Phase I trials this year.
• Investment in Stalicla: A private clinical-stage company focusing on neurodevelopmental disorders, making progress with its patient stratification technology.

3. Forward Guidance and Outlook

• Clinical Development: Anticipation of IND-enabling studies for the GABAB PAM program and further progress in the dipraglurant program.
• Neurosterix: Expected to announce further advancements in its pipeline in the coming months.
• Stalicla: Actively pursuing Series C financing and potential out-licensing opportunities, with an IPO being considered as a future funding mechanism.

4. Bad News, Challenges, or Points of Concern

• Cash Constraints: Current cash reserves are insufficient to advance unpartnered programs into clinical trials, posing a risk to the pipeline.
• Market Competition: The commercial outlook for chronic cough treatments is uncertain, especially with the underperformance of gefapixant and challenges in gaining market traction.
• Regulatory and Clinical Risks: The need for financing to initiate IND-enabling studies raises concerns about the timeline and feasibility of advancing key programs.

5. Notable Q&A Insights

• Chronic Cough Market: The CEO noted significant unmet medical needs, with up to 50% of patients not benefiting from current treatments, indicating a potential market opportunity for GABAB PAM.
• Stalicla's Progress: The company is working on a Series C financing and out-licensing opportunities, which could provide critical funding for clinical programs.
• Post-Stroke Recovery: Insights from ongoing studies like the CAMAROS trial could inform the development of dipraglurant, highlighting the potential for pharmacological agents to enhance recovery.
• Indivior Collaboration: While Indivior has made progress, specific future plans remain undisclosed, indicating a need for transparency in the partnership's developments.

Overall, while Addex Therapeutics has made strides in its R&D pipeline, financial constraints and competitive pressures present challenges that need to be addressed to ensure continued progress and growth.