• XanaMIA phase 2b/3 AD clinical trial progressing patient recruitment and randomization
• Commercial readiness initiatives including regulatory meetings, partnering, manufacturing, and publication of peer-reviewed papers
• Unique International Nonproprietary Name (INN) granted by the World Health Organization (WHO) for Xanamem (emestedastat)

Actinogen Medical announced its December 2024 quarterly activity report and Appendix 4C, highlighting progress in the XanaMIA phase 2b/3 Alzheimer's disease (AD) trial, which is enrolling 220 participants with elevated levels of the blood biomarker pTau181. The first US patient was randomized on 9 December 2024, and patient recruitment and randomization activities are stepping up following the expected slowdown over the holiday period. The company has an active recruitment 'funnel' consisting of more than 300 pre-screened patients, with approximately 40 randomized and treated and more than 20 in the intermediate stages of the screening process. An interim analysis is planned when approximately 100 patients reach 24 weeks of treatment, which is anticipated in Q4 2025. The timeline for final results is unchanged and these are anticipated in H2 2026.The company is also engaged in a range of commercial readiness initiatives, including regulatory meetings, partnering discussions, manufacturing scale-up, and publication of peer-reviewed academic papers. Additionally, the World Health Organization (WHO) granted the nonproprietary name 'emestedastat' to Actinogen for Xanamem, recognizing it as the first drug to be named for the class of enzyme inhibitors of 11β-HSD1.During the quarter, the company's R&D expenditure was consistent with the previous quarter, primarily focused on accelerating recruitment for the XanaMIA trial. The significant influx of cash from the R&D tax incentive and a further capital raising resulted in a positive operating cash position for the quarter of $5.3 million, and a closing cash balance of $22.9 million at 31 December 2024, which is expected to fund the company through mid-late CY2026.