Immunic(US:IMUX)2023-11-14 15:53Financial Data and Key Metrics Changes - For Q3 2023, the net loss was approximately $22.8 million or $0.51 per share, compared to a net loss of approximately $21.2 million or $0.69 per share in Q3 2022 [19] - R&D expenses for Q3 2023 were $19.8 million, up from $16.5 million in Q3 2022, driven by external development costs related to ongoing clinical trials [9] - For the nine months ended September 30, 2023, net loss was approximately $72 million or $1.63 per share, compared to a net loss of approximately $63.9 million or $2.16 per share for the same period in 2022 [36] Business Line Data and Key Metrics Changes - Vidofludimus calcium showed a 20% reduction versus placebo in secondary progressive multiple sclerosis (SPMS) patients, indicating significant efficacy in a difficult-to-treat population [4] - IMU-856 demonstrated positive effects in a Phase 1b clinical trial for celiac disease, showing improvements in gut architecture, symptoms, biomarker response, and nutrient absorption [7] Market Data and Key Metrics Changes - The CALLIPER trial included 467 patients with various forms of progressive MS, with interim data showing a 22.4% improvement in serum neurofilament light chain (NfL) levels compared to placebo [11] - The company received a notice of allowance for a patent covering the treatment of relapsing MS with vidofludimus calcium, expected to provide protection until 2041 [31] Company Strategy and Development Direction - The company aims to identify a partner for IMU-856 to conduct Phase 2 clinical trials, while for vidofludimus calcium, positive biomarker data has triggered discussions with pharmaceutical companies [8] - The focus is on leveraging strong clinical data to enhance business development opportunities and explore non-dilutive financing options [51] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of vidofludimus calcium as a first oral treatment for non-active SPMS, contingent on positive outcomes from ongoing trials [37] - The company is preparing for a Phase 2 trial for IMU-856 in celiac disease, with a focus on ensuring a robust trial design and regulatory interactions [64] Other Important Information - The company ended Q3 2023 with $59.7 million in cash and cash equivalents, expected to fund operations into September 2024 [33] - Other income for Q3 2023 was $0.8 million, an improvement from negative $1.1 million in Q3 2022, primarily due to decreased foreign exchange losses and increased interest income [18] Q&A Session Summary Question: Can you provide insight into the Phase 2 trial for IMU-856 in celiac disease? - Management indicated that preparations are ongoing, with a likely treatment phase of 3 months for active celiac disease patients [24] Question: How is enrollment progressing in the ENSURE program? - Management maintained guidance for completion of enrollment by the end of 2025 [25] Question: What data is expected to be reported in April 2025 from the CALLIPER trial? - The primary endpoint will be brain volume change, with secondary endpoints including confirmed disability worsening [26] Question: What is the bar of success for the CALLIPER trial? - Management noted that the study is designed to be powered for brain atrophy benefit, with a focus on meaningful medical differences in disability prevention [52][53] Question: Are there any updates on early pipeline programs like IMU-381? - Management stated that the focus is currently on clinical programs for vidofludimus calcium and IMU-856, with prioritization based on data and unmet needs [76]