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Sep 30, 2022
Immunic Q3 2022 Earnings Report
Reported financial results for the third quarter ended September 30, 2022 and provided a corporate update.
Key Takeaways
Immunic reported its Q3 2022 financial results, highlighting a cash and cash equivalents balance of $72.8 million as of September 30, 2022, and a subsequent $56.4 million net cash raise in October 2022, expected to fund the company into the fourth quarter of 2024. The company is progressing the development of vidofludimus calcium (IMU-838) in multiple sclerosis (MS) and anticipates data from the first of its phase 3 ENSURE trials in relapsing MS by the end of 2025.
Cash and cash equivalents totaled $72.8 million as of September 30, 2022.
Net cash of $56.4 million was raised in October 2022, expected to fund Immunic into the fourth quarter of 2024.
Phase 2 CALLIPER trial in progressive MS continues to enroll patients, with an interim analysis expected in the second half of 2023 and top-line data at the end of 2024.
Data from the first of phase 3 ENSURE trials in relapsing MS is anticipated by the end of 2025.
Immunic
Immunic
Forward Guidance
Immunic anticipates several clinical milestones, including data from the CALLIPER trial in progressive MS and the ENSURE trials in relapsing MS.
Positive Outlook
- CALLIPER trial designed to corroborate the neuroprotective potential of vidofludimus calcium.
- Positive unblinded safety, tolerability and pharmacokinetic (PK) results from Part A (single ascending doses, SAD) and Part B (multiple ascending doses, MAD) of the IMU-856 trial in healthy human subjects.
- Receipt of notice of allowance from the U.S. Patent and Trademark Office for a key composition-of-matter patent for IMU-856, providing protection into at least 2038.
- The design of the ENSURE program provides a straightforward path towards potential regulatory approval in relapsing MS.
- Company is on sound financial footing, having significantly bolstered balance sheet in October with the closing of a $60 million private placement, providing runway through multiple value inflection points into the fourth quarter of 2024.
Challenges Ahead
- Group-level data from the phase 1b clinical trial of IMU-935 in patients with moderate-to-severe psoriasis did not show a benefit of the first two active doses tested compared to placebo.
- Full and final analysis of data from the IMU-935 trial is needed to understand early observations and determine the best next steps for this key program.
- R&D expenses increased by $7.8 million for the nine months ended September 30, 2022.
- G&A expenses increased by $1.6 million for the nine months ended September 30, 2022.
- Loss on an intercompany loan between Immunic, Inc. and Immunic AG increased by $1.2 million.