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Mar 31, 2021
Immunic Q1 2021 Earnings Report
Reported financial results for the first quarter and highlighted recent activity.
Key Takeaways
Immunic reported its Q1 2021 financial results, highlighting the confirmation of the 30 mg dose of IMU-838 as most appropriate for the planned Phase 3 program in relapsing-remitting multiple sclerosis and the securing of full rights to IMU-838 with the settlement of the remaining royalty obligation to 4SC AG for $17.25 million.
Confirmed 30 mg dose of IMU-838 as most appropriate for planned Phase 3 program in relapsing-remitting multiple sclerosis (RRMS).
Secured full rights to IMU-838 with settlement of remaining royalty obligation to 4SC AG for $17.25 million.
Reported positive top-line data from the investigator-sponsored, open-label phase 2 trial of IMU-838 in primary sclerosing cholangitis (PSC).
$114.8 million in cash and cash equivalents expected to fund Immunic into the second half of 2022.
Immunic
Immunic
Forward Guidance
Immunic expects to initiate the phase 3 program in RRMS in the second half of 2021 and plans to initiate a phase 1 trial in hepatic impaired patients with PSC. Recruitment for the phase 2 trial in ulcerative colitis (UC) is expected to be completed in the second half of this year.
Positive Outlook
- Initiate phase 3 program in RRMS in the second half of 2021.
- Initiate phase 1 trial in hepatic impaired patients with PSC.
- Complete recruitment for phase 2 trial in ulcerative colitis (UC) in the second half of this year.
- File an Investigational New Drug (IND) application in the United States.
- Continue clinical program activities for IMU-838.
Challenges Ahead
- Opportunity to execute a phase 3 program as a monotherapy for COVID-19 is no longer viable.
- COVID-19 pandemic may impact clinical trial timelines.
- Risks and uncertainties associated with the ability to project future cash utilization.
- Earlier studies and trials may not be predictive of future clinical trial results.
- Risks related to the drug development and the regulatory approval process.