Addex Therapeutics (ADXN) H1 2024 earnings summary

Executive summary

• Neurosterix spin-out completed via a $63M (CHF 63M) Series A, securing $5M (CHF 5.0 million) and a 20% equity stake, enabling advancement of preclinical assets without diluting shareholders' interest in clinical-stage programs.

• Reported net profit of CHF 9.8 million for H1 2024, driven by a CHF 14.0 million gain from the Neurosterix Transaction, compared to a net loss of CHF 5.1 million in H1 2023.

• Significant progress in GABAB PAM program: Indivior selected a compound for substance use disorders, with IND-enabling studies expected in H1 2025; Addex to advance GABAB PAM for chronic cough.

• Dipraglurant repositioned for brain injury recovery, leveraging promising preclinical data.

• Lead partnered drug candidate ADX71149 failed to meet primary endpoint in Phase 2 epilepsy study; Janssen terminated its development in July 2024, but partnership continues for data analysis.

Financial highlights

• Q2 2024 income from continuing operations was $0.1M; H1 2024 revenue was CHF 0.3 million, both down from prior year periods due to lower collaborative research funding.

• R&D expenses for continuing operations stable at $0.3M in Q2 2024; operating loss from continuing operations was CHF 1.7 million in H1 2024.

• G&A expenses stable at $0.7M in Q2 2024.

• Cash and cash equivalents at end of Q2 2024 were CHF 3.8M.

• Accumulated deficit was CHF 350.6 million as of June 30, 2024.

Outlook and guidance

• Existing cash and cash equivalents expected to fund operations through 2026.

• IND-enabling studies for GABAB PAM programs in substance use disorders and chronic cough planned for 2025, subject to financing.

• Dipraglurant clinical development for brain injury recovery ready to restart.

• Neurosterix’s M4 PAM program for schizophrenia on track for IND-enabling studies completion by mid-2025, with phase I targeted for H2 2025.

• Additional funding will be required for future development, regulatory, and commercialization activities.