EXACT Therapeutics (EXTX) H2 2023 earnings summary

Executive summary

• 2023 clinical proof-of-concept supported ACT as safe, with encouraging anti-tumour effects in the Phase 1 ACTIVATE trial for patients with liver metastases.

• Development priorities are completing ACTIVATE dose expansion and advancing ENACT, a planned Phase 2 trial of ACT in first-line pancreatic cancer treatment.

Financial highlights

• Group operating expenses were NOK 48.4 million in 2023, up from NOK 41.2 million in 2022; the increase mainly reflected employee-related costs.

• Group net loss was NOK 48.3 million versus NOK 40.1 million in 2022; basic and diluted EPS were both NOK -1.51 versus NOK -1.34.

• Net cash outflow from operating activities was NOK 43.8 million; year-end cash and cash equivalents were NOK 46.4 million, down from NOK 69.4 million.

• Government grants recognised as cost reductions were NOK 6.6 million in 2023 versus NOK 9.2 million in 2022.

Outlook and guidance

• ENACT Phase 2 is planned to start in H2 2024, subject to securing financing and progressing the FDA IND process; first interim results are expected in H2 2025.

• ACTIVATE dose expansion is expected to conclude in 2024; preclinical work is also expected to progress in glioblastoma, CNS diseases and gene therapy.