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Dec 31, 2023
Immunic Q4 2023 Earnings Report
Immunic reported financial results for Q4 2023 and provided a corporate update, highlighting a significantly strengthened balance sheet with a private placement extending cash runway into Q3 2025.
Key Takeaways
Immunic reported its Q4 2023 financial results, emphasizing the successful three-tranche private placement of up to $240 million, which extends the company's cash runway into the third quarter of 2025. The company also highlighted positive interim data from its Phase 2 CALLIPER trial and the ongoing Phase 3 ENSURE program.
Secured a three-tranche private placement of up to $240 million, extending cash runway into the third quarter of 2025.
Reported encouraging interim biomarker analysis from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis.
Phase 3 ENSURE program in relapsing multiple sclerosis is ongoing.
Expanded patent portfolio for vidofludimus calcium, providing exclusivity protection into 2041 in the United States.
Immunic
Immunic
Forward Guidance
Immunic anticipates several clinical milestones, including an interim futility analysis for the Phase 3 ENSURE program expected late this year, and the read-out of the first of the ENSURE trials anticipated in the second quarter of 2026. Top-line CALLIPER data is expected in April 2025.
Positive Outlook
- Potential to position vidofludimus calcium as the first oral treatment option for advanced SPMS if CALLIPER data continues to show a neuroprotective effect.
- Vidofludimus calcium has the potential to be a unique treatment option targeted to the complex pathophysiology of MS, based on its combined neuroprotective, anti-inflammatory, and antiviral effects.
- Demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption.
- Preparing for phase 2 testing in ongoing active celiac disease (OACD) and are considering additional clinical applications in other gastrointestinal disorders.
- Extensive patent portfolio now provides protection into 2041 in the United States, unless extended further.
Challenges Ahead
- Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements.
- Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials
- Risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations
- The availability of sufficient financial and other resources to meet business objectives and operational requirements
- The fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results