Abiopharma

Immunic Inc (IMUX) Reports Q3 2022 Financial Results Immunic Inc (IMUX) announced its financial results for the period ending Q3 2022. Key Financial Highlights:

• Revenue: $16,538
• Net Income: Not disclosed
• EPS: Not disclosed
• Cash and equivalents: 88078
  • Expected in the Fourth Quarter – – Unblinded Safety Data from the Single and Multiple Ascending Dose Parts of Phase 1 Clinical Trial of IMU-856 in Healthy Human Subjects Expected in the Third Quarter – – $88.1 Million in Cash and Cash Equivalents Expected to Fund Immunic Into the Fourth Quarter of 2023
  • targeting restoration of intestinal barrier function and regeneration of bowel epithelium. Clinical Updates ·Update on the use of steroids in the phase 2 EMPhASIS trial of vidofludimus calcium in RRMS: Based on the observed interaction between vidofludimus calcium and chronic steroid use in the CALDOSE-1 trial in UC patients, Immunic performed a post-hoc analysis of the phase 2 EMPhASIS data in RRMS patients to explore the potential influence of steroids on these study results. As anticipated, steroid use was rare and among those RRMS patients who received any steroids, the majority received only short steroid courses following relapse events or acute neurological events. Comparing patients who received at least one dose of corticosteroids with those who did not, Immunic does not see any difference in clinical parameters or any evidence that the rare, short-term use of steroids in RRMS patients has any influence on the effectiveness of vidofludimus calcium in this patient population. ·Results of exploratory phase 1 drug-drug interaction (DDI) study of IMU-935: An exploratory phase 1 study was completed in 15 evaluable healthy human subjects to assess the DDI potential of IMU-935. No relevant signals for DDI potential were observed and treatment was safe and well-tolerated. ·Update on phase 1 clinical trial of IMU-935 in metastatic castration-resistant prostate cancer (mCRPC) – initial safety data available: The first two dose cohorts of the phase 1 clinical trial of IMU-935 in mCRPC have been fully recruited, with 6 patients enrolled in the 300 mg cohort and 6 patients in the 600 mg cohort. Of these patients, all have completed the initial 28-day safety study part without reaching dose limiting toxicity (DLT). The third, 900 mg cohort is expected to start dosing soon. Initial safety data available so far show a promising safety profile of IMU-935 in mCRPC, with only benign adverse events and no dose limiting toxicities. Immunic plans to provide a more comprehensive update on safety and also on potential signs of anti-tumor activity of IMU-935 in this trial as soon as data from the planned dose expansion part are available. Anticipated Clinical Milestones ·Vidofludimus calcium in MS: Immunic has carefully analyzed the impact that current events in the Ukraine and Russia may have on its ongoing clinical programs. Based on this assessment, the current goal is to report data from the interim analysis of the phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) in the second half of 2023