Immunic Q1 2021 Earnings Report
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.