Immunic(IMUX) - 2024 Q3 - Quarterly Results

Corporate Update and Pipeline Progress Vidofludimus Calcium Program (MS Treatment) The company's lead asset, vidofludimus calcium, is advancing as planned. The Phase 3 ENSURE program in relapsing multiple sclerosis (RMS) passed a key interim futility analysis, with the Independent Data Monitoring Committee (IDMC) recommending continuation without modification. The Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS) is on track, with top-line data expected in April 2025, which could position the drug as the first oral treatment for non-relapsing secondary progressive MS (SPMS). Recent data presented at ECTRIMS further supports the drug's neuroprotective, anti-inflammatory, and anti-viral potential - A non-binding interim futility analysis of the Phase 3 ENSURE program for RMS was positive, with the IDMC recommending the trials continue as planned without any sample size increase[1][2][4] - Top-line data from the Phase 2 CALLIPER trial in PMS is expected in April 2025. Positive results could position vidofludimus calcium as the first oral treatment for non-relapsing SPMS[1][2][8] - Data presented at the ECTRIMS congress highlighted a clear separation from placebo in neurofilament light chain (NfL) levels, supporting the drug's potential to slow disease progression in PMS[2] - The company believes vidofludimus calcium's combined neuroprotective, anti-inflammatory, and anti-viral effects could represent a unique new treatment option for the complex pathophysiology of MS[2] IMU-856 Program (Gastrointestinal Disorders) Immunic is continuing preparations for Phase 2 clinical trials for IMU-856, a small molecule modulator targeting SIRT6 for gastrointestinal disorders. This advancement is contingent on securing financing, licensing, or a partnership. The decision is based on positive Phase 1b data in celiac disease, which demonstrated beneficial effects on gut architecture, patient symptoms, biomarkers, and nutrient absorption, suggesting a novel therapeutic approach by restoring bowel wall integrity - The company is preparing for Phase 2 clinical testing of IMU-856, but this is contingent on securing financing, licensing, or a partnership[3][8] - Phase 1b clinical trial data in celiac disease patients showed IMU-856 had positive effects on gut architecture, symptoms, biomarker response, and nutrient absorption compared to placebo[3] - Based on encouraging data, the company is considering additional clinical applications for IMU-856 in other gastrointestinal disorders[3] Third Quarter 2024 and Subsequent Highlights During and after the third quarter of 2024, Immunic achieved several key milestones. These include a positive futility analysis for its Phase 3 ENSURE program, presentation of key data at the ECTRIMS congress, enrollment of the first patient in a post-COVID syndrome trial, and strategic appointments to its Board of Directors and management team to prepare for potential commercialization - October 2024: Announced a positive outcome of the interim futility analysis for the Phase 3 ENSURE program, with the IDMC recommending continuation without changes[4] - September 2024: Presented key data at ECTRIMS, hosted an MS R&D Day, and enrolled the first patient in an investigator-sponsored Phase 2 trial for post-COVID syndrome[5] - July 2024: Appointed Simona Skerjanec to the Board of Directors and Jason Tardio as Chief Operating Officer to strengthen the company for potential product launch and partnerships[6][7] Anticipated Clinical Milestones Immunic has outlined several key upcoming clinical milestones. The most immediate is the expected release of top-line data from the Phase 2 CALLIPER trial in progressive multiple sclerosis in April 2025. The company also provided long-term timelines for its Phase 3 ENSURE trials, with completions expected in 2026. Advancement of the IMU-856 program into Phase 2 remains dependent on securing additional funding or partnerships - Top-line data from the Phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April 2025[8] - Completion of the Phase 3 ENSURE-1 trial is anticipated in Q2 2026, with ENSURE-2 completion expected in H2 2026[8] - Phase 2 testing of IMU-856 in celiac disease is being prepared for, but is contingent on financing, licensing, or partnering[8] Financial Results Financial Performance Summary (Q3 & 9M 2024) In the third quarter of 2024, Immunic reported a net loss of $24.4 million, or $0.24 per share. For the nine months ended September 30, 2024, the net loss was $75.3 million, or $0.75 per share. The company concluded the quarter with $59.1 million in cash and cash equivalents, which is expected to fund operations into the third quarter of 2025 | Metric | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $24.4 million | $22.8 million | $75.3 million | $72.0 million | | Net Loss Per Share | $0.24 | $0.51 | $0.75 | $1.63 | | Weighted Avg. Shares | 101,272,580 | 44,574,377 | 99,998,245 | 44,227,264 | - As of September 30, 2024, cash and cash equivalents were $59.1 million[19] - The current cash position is expected to fund operations into the third quarter of 2025[19] Detailed Expense Analysis For Q3 2024, R&D expenses increased by $1.6 million year-over-year to $21.4 million, driven primarily by costs for the vidofludimus calcium program. G&A expenses rose by $0.6 million to $4.4 million due to higher personnel costs. For the nine-month period, R&D expenses decreased by $5.5 million to $58.4 million, mainly from deprioritizing the izumerogant program, while G&A expenses increased by $2.1 million to $14.0 million | Expense Category | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $21.4 million | $19.8 million | $58.4 million | $63.9 million | | G&A Expenses | $4.4 million | $3.8 million | $14.0 million | $11.9 million | - The $1.6M increase in Q3 R&D expenses was mainly due to a $1.4M increase in external development costs for the vidofludimus calcium program[9] - The $5.5M decrease in nine-month R&D expenses was primarily driven by a $4.1M reduction from deprioritizing the izumerogant program[10] - The increase in G&A expenses for both the three- and nine-month periods was primarily due to higher personnel costs, including non-cash stock compensation and increased headcount[11][12] Other Income and Non-cash Items For the nine months ended September 30, 2024, the company recorded a $4.8 million non-cash charge for the Change in Fair Value of Tranche Rights related to a January financing. Other income for Q3 2024 increased to $0.6 million due to Australian R&D tax incentives. However, for the nine-month period, other income (expense) shifted to a $1.1 million expense from a $1.3 million income in the prior year, mainly due to financing deal costs and lower grant income - A non-cash charge of $4.8 million was recorded for the nine months ended Sep 30, 2024, related to the revaluation of tranche rights from a January 2024 financing upon their reclassification to equity[14] - Other income for Q3 2024 was $0.6 million, a $0.5 million increase from the prior year, primarily due to a $0.6 million increase in R&D tax incentives for clinical trials in Australia[15] - For the nine-month period, other income (expense) decreased by $2.4 million year-over-year, mainly due to a $1.7 million expense for financing deal costs and a $1.1 million grant recognized in 2023 that did not recur in 2024[16] Financial Statements Condensed Consolidated Statements of Operations The company's total operating expenses for Q3 2024 were $25.7 million, leading to a loss from operations of the same amount. After accounting for other income of $1.4 million, the net loss for the quarter was $24.4 million. For the nine-month period, total operating expenses were $72.4 million, and a net loss of $75.3 million was reported, which includes a $2.9 million expense from other income/expense items | (In thousands) | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $21,370 | $19,796 | $58,429 | $63,931 | | General and administrative | $4,356 | $3,774 | $13,992 | $11,911 | | Total operating expenses | $25,726 | $23,570 | $72,421 | $75,842 | | Loss from operations | ($25,726) | ($23,570) | ($72,421) | ($75,842) | | Total other income (expense) | $1,358 | $801 | ($2,911) | $3,802 | | Net loss | ($24,368) | ($22,769) | ($75,332) | ($72,040) | | Net loss per share | ($0.24) | ($0.51) | ($0.75) | ($1.63) | Condensed Consolidated Balance Sheets As of September 30, 2024, Immunic's balance sheet showed total assets of $64.8 million, an increase from $54.3 million at the end of 2023. This was primarily driven by an increase in cash and cash equivalents to $59.1 million. Total liabilities decreased slightly to $23.5 million. Consequently, total stockholders' equity increased to $41.2 million from $28.9 million at year-end 2023 | (In thousands) | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $59,071 | $46,674 | | Total current assets | $63,266 | $52,534 | | Total assets | $64,762 | $54,299 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $23,357 | $24,729 | | Total liabilities | $23,543 | $25,368 | | Total stockholders' equity | $41,219 | $28,931 | | Total liabilities and stockholders' equity | $64,762 | $54,299 |