Immunic Inc · Q2 2021 earnings

Briefing

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.

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.

Headline financials

Revenue & EPS history

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.