Immunic(IMUX) - 2025 Q1 - Quarterly Report

Financial Position - Immunic, Inc. reported an accumulated deficit of approximately $536.9 million as of March 31, 2025, up from$511.4 million as of December 31, 2024[152]. - As of March 31, 2025, Immunic had cash and cash equivalents of approximately $14.3 million, which is insufficient to fund operations for at least twelve months without raising additional capital[153]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[162]. - Cash and cash equivalents were approximately$14.3 million as of March 31, 2025, indicating inadequate liquidity to fund operations for at least twelve months without raising additional capital[181]. - As of March 31, 2025, the Company had approximately $14.3 million in cash and cash equivalents[199]. - The Company filed a shelf registration statement in November 2023 allowing for the offering of up to$250 million in various securities, with a total shelf availability of approximately $412.3 million as of March 31, 2025[184]. - The Company incurred no cash from financing activities for the three months ended March 31, 2025, compared to$74.4 million in the same period of the previous year[205][206]. Clinical Trials and Product Development - The Phase 3 ENSURE program for vidofludimus calcium in relapsing multiple sclerosis (RMS) is ongoing, with completion expected in the second quarter of 2026[139]. - Positive interim data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) showed substantial reductions in disability progression and thalamic brain volume[140]. - IMU-856 demonstrated positive effects in a Phase 1b clinical trial for celiac disease, including protection of gut architecture and improvement of symptoms[144]. - The company is preparing for a Phase 2 clinical trial of IMU-856 in patients with ongoing active celiac disease[144]. - Immunic is focused on executing ongoing clinical trials and exploring additional indications for its product candidates[150]. - Vidofludimus calcium reduced the relative risk of 24-week confirmed disability worsening by 30% in primary progressive multiple sclerosis patients compared to placebo[156]. - IMU-856 demonstrated a dose-dependent increase of endogenous GLP-1 levels in celiac disease patients, with significant increases of 80 mg (p=0.014) and 160 mg (p=0.003) compared to placebo[155]. Financial Performance - The company incurred a net loss of $25.5 million for the three months ended March 31, 2025, a decrease of 14$29.6 million for the same period in 2024[173]. - Research and development expenses increased by $2.8 million (15$21.5 million for the three months ended March 31, 2025, compared to $18.7 million for the same period in 2024[173][174]. - The total operating expenses for the three months ended March 31, 2025, were$26.8 million, an increase of 12% from $23.9 million in the same period in 2024[173]. - Interest income decreased by$1.0 million (85%) to $183,000 for the three months ended March 31, 2025, compared to$1.2 million for the same period in 2024[173][175]. - For the three months ended March 31, 2025, operating activities used $21.8 million in cash, primarily due to a net loss of$25.5 million[201]. Strategic Plans and Collaborations - Immunic plans to evaluate potential strategic collaborations to enhance the commercialization of its product candidates[151]. - The Company expects future expenses to increase as it continues research, development, and clinical trials for its product candidates[196]. - The Company has non-cancelable contractual obligations totaling approximately $2.6 million related to its development programs, expected to be paid in 2025 and 2026[210]. Currency and Inflation Risks - The company has significant exposure to foreign currency exchange rates, primarily the Euro and the Australian dollar, which could adversely affect financial results[214]. - A 10$1.3 million on net current liabilities as of March 31, 2025[216]. - For the three months ended March 31, 2025, a 10% change in foreign currency exchange rates would have impacted the company's net loss by approximately $2.0 million, primarily due to the Euro[216]. - The company has not entered into any foreign currency hedging transactions and does not have current plans to do so[214]. - The company has experienced a general increase in costs due to global inflation, but does not believe it has had a material impact on operations[217]. - The company’s German subsidiary is a significant portion of its business, and fluctuations in exchange rates could affect its consolidated financial position[215]. Accounting and Disclosure - The company has adopted ASU No. 2023-09 for income tax disclosures, effective January 1, 2025, which will improve the consistency and disaggregation of information[212]. - The company evaluates its accounting estimates and assumptions on an ongoing basis, which may differ from actual results under different conditions[211].