This is why I continue to hold10 Mar 2022 11:36
From Edison:
Sareum’s H122 results (to end-December 2021) provided an update on the company’s progress with its therapeutic pipeline. With final toxicology and safety studies for lead asset SDC-1801 completed in Q4 of CY21 (final report expected by end-Q122), the company is on track to file an exploratory clinical trial application (CTA) in mid-2022 and start clinical studies in H222. The cash balance of £5.6m at the end of H1 should be sufficient to take SDC-1801 through Phase Ia clinical trials and accelerate SDC-1802’s preclinical progress, with the company continuing to assess options to further clinical development. Sareum completed the 50:1 share consolidation it announced at the December 2021 AGM, with the new shares starting trading on 1 March.
SDC-1801 remains on track to enter the clinic in 2022
SDC-1801, Sareum’s lead TYK2/JAK1 inhibitor, is on track for a mid-2022 CTA filing and a subsequent clinical entry in H2 CY22 after completion of final pre-clinical toxicology studies in Q421. While the full study will be available towards the end of March, early findings are encouraging and Sareum says they support its clinical plans. Development of the capsule formulation is progressing on schedule, with the synthesis of the drug’s active pharmaceutical ingredient (API) under Good Manufacturing Practice (GMP) conditions nearing completion.
SDC-1801 trial design
As per available information, the Phase Ia study would be a safety and dose-finding (ascending doses) study in healthy volunteers, with the initial target indication to be decided thereafter. The trial will also investigate early efficacy signals by looking at SDC-1801’s effect on certain biomarkers of autoimmune disease. The company indicated it is working with specialist clinical trial consultants to design the trial and we expect more details in the coming months. According to management, cash at end-December 2021 (£5.6m) remains sufficient to complete the Phase Ia study, after which the company will assess further fundraising or outlicensing/partnerships to progress SDC-1801’s clinical development.
Share consolidation complete
After the company’s communication of a planned share consolidation in 2022, Sareum effected a 50:1 share consolidation from 1 March. The key objective was to help improve Sareum’s attractiveness to institutional investors.