Addex Therapeutics Ltd Q3 FY2025 earnings call

Key Points

• Progress in GABAB PAM program: Completed preclinical characterization of selected compound and selected a backup compound.
• Dipraglurant repositioning: Repositioned for post-stroke recovery with ongoing preclinical work in collaboration with Sinntaxis and the University of Lund.
• Spin-out Neurosterix: Advancing preclinical programs, including an M4 PAM schizophrenia program on track to dose patients in 2025.
• Investment in Stalicla: Stalicla has a precision medicine patient stratification platform for neurodevelopmental disorders, with progress in autism studies and discussions with pharma for broader application.
• Cash position: Ended Q3 with CHF 2.2 million cash, providing runway through mid-2026 with reduced burn post-Neurosterix spinout.
• Dipraglurant details: Orally available mGlu5 negative allosteric modulator with preclinical evidence supporting post-stroke recovery, good tolerability, and strong patent position.
• GABAB PAM for cough: Completed pre-IND activities with a clinical candidate showing favorable efficacy, tolerability, and developability profiles, ready for IND-enabling studies with financing.

Addex Therapeutics ended the third quarter of 2025 with CHF 2.2 million in cash. Income for the quarter was CHF 0.1 million, primarily from patents licensed to Indivior. R&D expenses in Q3 2025 were CHF 0.2 million, primarily related to the GABAB PAM program. G&A expenses were CHF 0.5 million. Noncurrent assets totaled CHF 5 million as of September 30, 2025, including a 20% equity interest in Neurosterix Group and an investment in Stalicla.

Forward-Looking Statements

• Cash runway extends through mid-2026.
• Neurosterix's M4 PAM program is on track to dose patients in 2025, with further progress expected in coming months.
• Stalicla is working on a Series C financing to fund Phase II clinical studies in autism spectrum disorders.
• Indivior's GABAB PAM program for substance use disorders, which completed IND-enabling studies, is progressing towards further development.

Risks Identified

• Current cash does not fund progression of unpartnered programs into clinical trials.
• Uncertainties in clinical trial timelines and regulatory approvals for various programs, including potential delays in IND-enabling studies for GABAB PAM cough program without additional financing.

Q: Comment on the commercial outlook for a potential therapeutic intervention in chronic refractory cough, particularly in the context of gefapixant not being a factor in the US market.

A: Tim Dyer noted chronic cough is a significant unmet medical need, with baclofen having limitations due to dosing and sedative effects. Misha Kalinichev added that P2X3 inhibitors like gefapixant only address a single peripheral mechanism, while GABAB PAMs can address central and other peripheral mechanisms.

Q: What is the next funding catalyst for Stalicla and outlook for a public listing?

A: Stalicla is working on a Series C financing to fund Phase II clinical studies for subpopulations in autism spectrum disorders and is also out-licensing an asset. The company is a private entity currently focused on private financing, with no immediate plans for a public listing but considering it as a potential funding mechanism in the future.

Q: Context around competitive clinical development in the post-stroke recovery space, particularly regarding CCR5 receptor modulators and the CAMAROS trial?

A: Tim Dyer and Misha Kalinichev discussed the CAMAROS trial with CCR5 modulators and noted learnings from it for dipraglurant's development. They highlighted parallels between CCR5 modulators and mGlu5 inhibitors like dipraglurant, with an emphasis on addressing sensory and motor recovery readouts.

Q: What are Indivior's next steps in the ongoing collaboration and catalysts expected in 2026?

A: Indivior successfully completed IND-enabling studies for their GABAB PAM drug candidate for substance use disorders and is preparing to move the program forward. Specific details on future catalysts in 2026 were not disclosed, but the company is progressing with the program as per the agreement.