Immunic(IMUX)2023-05-14 15:26Financial Data and Key Metrics - The company ended Q1 2023 with $97.1 million in cash and investments, expected to fund operations into Q4 2024 [14] - Net loss for Q1 2023 was approximately $25.3 million, or $0.58 per basic and diluted share, compared to a net loss of $20.8 million, or $0.74 per basic and diluted share, in Q1 2022 [15] - Research and development expenses increased to $23 million in Q1 2023 from $17.4 million in Q1 2022, driven by external development costs for ongoing clinical trials [39] - General and administrative expenses rose slightly to $4.3 million in Q1 2023 from $4 million in Q1 2022, primarily due to increased travel expenses [7] Business Line Data and Key Metrics - IMU-856 demonstrated significant clinical improvements in celiac disease patients, including protection of gut architecture, symptom improvement, biomarker response, and enhanced nutrient absorption [37] - Vidofludimus calcium showed neuroprotective potential in progressive MS, with a low rate of confirmed disability worsening over time [11] - The company is exploring additional clinical applications for IMU-856 in other gastrointestinal disorders, such as Crohn's disease and ulcerative colitis [24][42] Market Data and Key Metrics - The company is preparing for a Phase 2b clinical trial of IMU-856 in active celiac disease patients, following positive Phase 1b results [42] - Interim biomarker analysis data from the CALLIPER trial in progressive MS is expected in H2 2023, with top-line data anticipated by the end of 2024 [16] Company Strategy and Industry Competition - The company believes IMU-856 represents a novel therapeutic approach for gastrointestinal disorders, potentially offering a game-changing treatment option [96] - Vidofludimus calcium is positioned as a unique treatment for multiple sclerosis, combining anti-inflammatory, antiviral, and neuroprotective effects [17] - The company is considering partnerships and business development opportunities for its pipeline programs, particularly for IMU-856 and vidofludimus calcium [80] Management Commentary on Operating Environment and Future Outlook - Management expressed excitement about the potential of IMU-856 and vidofludimus calcium, highlighting their unique mechanisms of action and clinical potential [18][96] - The company remains well-funded, with a strong cash position to support ongoing clinical trials and development milestones [89] Other Important Information - The company announced the addition of a new program, IMU-381, targeting gastrointestinal diseases, with preclinical development underway [76][84] - Dr. Richard Rudick joined the Board of Directors, bringing extensive expertise in multiple sclerosis and clinical trials [95] Q&A Session Summary Question: Confidence in IMU-856's mechanism of action and potential for other indications - Management highlighted preclinical and clinical data supporting IMU-856's efficacy, particularly in celiac disease, and its potential for other gastrointestinal disorders like Crohn's disease and ulcerative colitis [21][24] Question: Timeline for FDA meeting and Phase 2b design for IMU-856 - The company is working on finalizing the Phase 2b trial design and plans to submit an IND filing in the US soon, with discussions with regulators expected to follow [50] Question: Potential for IMU-856 in other GI diseases - Management indicated that while the focus is on celiac disease, Crohn's disease and ulcerative colitis are also promising indications for IMU-856 [62] Question: Interim results from the CALLIPER trial and their impact - The interim analysis will focus on biomarkers (NfL and GFAP levels) to assess treatment benefits in different MS patient subgroups, potentially influencing trial prioritization [67] Question: Follow-up on Phase 1b patients and target novelty of IMU-856 - No follow-up is planned for Phase 1b patients, as the trial was designed for proof-of-concept. The SIRT6 target is novel, with only one other company known to be working on it in a different context [71][72] Question: Business development interest and partnership opportunities - Management noted increased interest in IMU-856 following the celiac disease data and remains open to partnerships, with decisions based on value and strategic fit [79][80]