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Jun 30, 2021
Immunic Q2 2021 Earnings Report
Immunic reported second quarter 2021 financial results and highlighted recent activity, including FDA clearance for Twin IMU-838 Phase 3 ENSURE Trials and supportive Phase 2 CALLIPER Trial in Multiple Sclerosis.
Key Takeaways
Immunic reported progress with IMU-838 and IMU-935, with five data read-outs anticipated from clinical trials within the next twelve months and the initiation of the first phase 3 program. The company received FDA clearance for the phase 3 ENSURE program of IMU-838 and expects to complete recruitment of the phase 2 CALDOSE-1 trial. Immunic had $87.2 million in cash and cash equivalents as of June 30, 2021, and an additional $45.0 million was raised in July, expected to fund operations into 2023.
Received FDA Clearance to Initiate Twin IMU-838 Phase 3 ENSURE Trials in Relapsing-Remitting Multiple Sclerosis and Supportive Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis.
Reported In Vitro Data Showing That IMU-935 May Inhibit the Generation of Th17 Cells and Production of IL-17 Cytokines Without Impairing RORγt Function Required for Normal Thymocyte Development.
Reported Preclinical Data Establishing IMU-935 as a Potential Treatment for Castration-Resistant Prostate Cancer; Preparing for a Phase 1 Clinical Trial.
$87.2 Million in Cash and Cash Equivalents as of June 30, 2021 and the Additional $45.0 Million Raised in July are Expected to Fund Immunic Into 2023.
Forward Guidance
Immunic anticipates five data read-outs from clinical trials within the next twelve months and expects to begin their first phase 3 program very soon. Initiation of trials in the second half of the year will mark a major milestone. The company expects a phase 1 trial to commence during the fourth quarter of this year and anticipates initial human data from moderate-to-severe psoriasis patients from a phase 1 trial during the second quarter of 2022.
Positive Outlook
- FDA clearance for phase 3 ENSURE program of IMU-838.
- Completion of recruitment of phase 2 CALDOSE-1 trial of IMU-838 expected during the second half of 2021.
- Top-line data for CALDOSE-1 trial expected in the first half of 2022.
- Phase 1 trial of IMU-935 in metastatic CRPC patients expected to commence during the fourth quarter of this year.
- Initial human data from phase 1 trial of IMU-935 in psoriasis patients anticipated during the second quarter of 2022.
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