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Dec 31, 2019
Immunic Q4 2019 Earnings Report
Immunic reported financial results for the year ended December 31, 2019, and highlighted recent achievements, including the closing of a stock-for-stock exchange transaction and the completion of enrollment for the phase 2 EMPhASIS trial.
Key Takeaways
Immunic's 2019 was marked by the closing of a stock-for-stock exchange transaction and the completion of enrollment for the phase 2 EMPhASIS trial of IMU-838. The company anticipates reporting top-line results in the third quarter of 2020 and has cash of $29.4 million providing funding through key 2020 inflection points.
Completed enrollment for phase 2 EMPhASIS trial of IMU-838 in relapsing-remitting multiple sclerosis (RRMS) ahead of schedule.
Reported progress for IMU-838 in moderate-to-severe ulcerative colitis (UC) and primary sclerosing cholangitis (PSC).
Advanced earlier stage programs, including dosing healthy volunteers in phase 1 trial of IMU-935.
Exercised option for exclusive worldwide license to IMU-856 from Daiichi Sankyo, Co., Ltd.
Immunic
Immunic
Forward Guidance
Immunic anticipates several clinical milestones in the near future.
Positive Outlook
- Top-line data from Phase 2 EMPhASIS trial in Relapsing-Remitting Multiple Sclerosis expected in Q3 2020.
- Phase 2 trial in PSC ongoing at the Mayo Clinic.
- Top-line data from UC expected in the fourth quarter of 2021.
- Initiate phase 1 clinical studies of IMU-856 during the first half of 2020.
- Considered phase 2 trial in Crohn’s disease.
Challenges Ahead
- The company may not achieve the plans.
- Earlier studies and trials may not be predictive of future clinical trial results.
- Risks related to the drug development and the regulatory approval process.
- Impact of competitive products and technological changes.
- Ability to project future cash utilization and reserves needed for contingent future liabilities and business operations.