Addex Therapeutics (ADXN) H1 2024 earnings summary

Executive summary

• Neurosterix spin-out via a $63M (CHF 63M) Series A secured $5M (CHF 5.0 million) cash and a 20% equity stake, enabling advancement of preclinical assets and removing financing overhang.

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

• Lead partnered drug candidate ADX71149 failed to meet the primary endpoint in Phase 2 epilepsy study; Janssen terminated its development in July 2024, but partnership continues as phase II data are analyzed.

• Indivior selected a compound for substance use disorder; Addex exercised its right to advance a GABAB PAM for chronic cough, with IND-enabling studies expected in H1 2025.

• Dipraglurant repositioned for brain injury recovery, leveraging promising preclinical data and strong patent position.

Financial highlights

• Q2 2024 income from continuing operations was $0.1M, down from $0.6M in Q2 2023; revenue from continuing operations was CHF 0.3 million for H1 2024, down from CHF 1.1 million in H1 2023.

• Operating loss from continuing operations was CHF 1.7 million in H1 2024; net loss from continuing operations was CHF 2.2 million.

• Net profit for H1 2024 was CHF 9.8 million, mainly from a CHF 14.0 million gain on the Neurosterix Transaction.

• Cash and cash equivalents stood at CHF 3.8 million as of June 30, 2024, with other current assets at $0.9M.

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

• IND-enabling studies for both GABAB PAM (chronic cough) and Indivior-partnered substance use disorder program planned for 2025.

• Neurosterix's M4 PAM program for schizophrenia expected to complete IND-enabling studies by mid-2025, with phase I to follow in H2 2025.

• Ongoing evaluation of clinical targets for chronic cough, including refractory, unexplained, COPD, and IPF-related cough.

• Anticipates increased expenses as development of GABAB PAM for chronic cough advances and further clinical trials are initiated.