Immunic(US:IMUX)2023-08-06 05:59Financial Data and Key Metrics Changes - For the three months ended June 30, 2023, the net loss was approximately $24 million or $0.54 per share, compared to a net loss of approximately $21.9 million or $0.72 per share for the same period in 2022, reflecting an increase in loss despite a higher number of shares outstanding [9][70]. - General and administrative expenses were $3.8 million for the three months ended June 30, 2023, down from $4.1 million for the same period in 2022, primarily due to a decrease in non-cash stock compensation [43]. - Research and development expenses increased to $21.2 million for the three months ended June 30, 2023, from $16.5 million for the same period in 2022, driven by ongoing clinical trials [42][68]. Business Line Data and Key Metrics Changes - The Phase Ib data for IMU-856 showed effectiveness in improving key aspects of celiac disease, including gut architecture protection and nutrient absorption, indicating a positive trajectory for this program [4][35]. - The maintenance phase data for vidofludimus calcium in ulcerative colitis demonstrated a statistically significant improvement over placebo, confirming its activity in patients [3][39]. Market Data and Key Metrics Changes - The company reported an increase in other income to $3 million for the six months ended June 30, 2023, compared to a loss of $0.7 million for the same period in 2022, attributed to higher interest income and reduced foreign exchange losses [44]. - The company ended the quarter with $77.3 million in cash, expected to fund operations into the fourth quarter of 2024, indicating a stable financial position [67][87]. Company Strategy and Development Direction - The company is preparing for a Phase II clinical trial of IMU-856 in active celiac disease patients, aiming to establish it as a new oral treatment option for gastrointestinal diseases [12][35]. - The design of the Phase III ENSURE program for vidofludimus calcium is believed to provide a straightforward path to potential regulatory approval in relapsing multiple sclerosis [11][30]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing enrollment for the ENSURE trials, indicating that it is on track compared to planned enrollment [53]. - The company anticipates reporting data from the interim analysis of the Phase II CALLIPER trial in progressive MS in the fall of this year, with further updates expected on the Phase II clinical trial of IMU-856 [30][45]. Other Important Information - The company hosted a virtual expert roundtable on celiac disease, highlighting the unmet medical need for therapeutic solutions in this area [36]. - The company is exploring additional molecules that may benefit from the data obtained from the CALDOSE study, indicating potential for further development in gastrointestinal indications [19]. Q&A Session Summary Question: Can you provide insight into patient enrollment for ENSURE? - Management confirmed that enrollment is progressing well and is on track compared to expectations [53]. Question: What data do you expect to report with the interim biomarker analysis from the CALLIPER trial? - Management stated that they cannot quantify expectations but hope for good differentiation between active and placebo groups [51]. Question: What gives you confidence that the Nurr1 activator would work in progressive forms of multiple sclerosis? - Management noted that existing literature and preliminary data suggest potential efficacy, but clinical studies are needed to confirm this [82].