Immunic(US:IMUX)2023-05-11 10:52Financial Position - Immunic has an accumulated deficit of approximately $342.6 million as of March 31, 2023, with significant operating losses incurred since its inception in 2016[133]. - The company has raised net cash of approximately $355.6 million from private and public offerings, with cash and cash equivalents of approximately $92.8 million as of March 31, 2023[135]. - The company reported a net loss of $25.3 million for the three months ended March 31, 2023, compared to a net loss of $20.8 million for the same period in 2022, representing a 21% increase in losses[156]. - Total operating expenses for the three months ended March 31, 2023, were $27.3 million, a 27% increase from $21.4 million in the same period in 2022[156]. - The company has incurred a total of approximately $237.8 million in research and development expenses since its inception in March 2016, with the majority allocated to vidofludimus calcium[148]. - The company anticipates needing substantial additional funding for ongoing operations and product development, with no committed external sources of funds[168]. - The company has non-cancelable contractual obligations totaling approximately $4.4 million related to development programs, expected to be paid in 2023[178]. - As of March 31, 2023, the company had net current assets of $21.6 million subject to foreign currency translation risk, primarily from operations in Germany and Australia[185]. - A hypothetical 10% adverse change in foreign currency exchange rates could result in a decrease of approximately $2.2 million in net current assets as of March 31, 2023[185]. - The cost of debt financing has increased due to rising interest rates, which may affect future funding options[168]. Research and Development - Vidofludimus calcium (IMU-838) is in Phase 3 clinical development for relapsing multiple sclerosis (RMS) and is expected to report interim analysis data in the second half of 2023[121][123]. - IMU-856 has shown positive results in a Phase 1 clinical trial for celiac disease, demonstrating improvements in gut architecture, patient symptoms, biomarker response, and nutrient absorption[137]. - The company plans to initiate a Phase 2b clinical trial for IMU-856 in patients with ongoing active celiac disease[137]. - The Phase 3 ENSURE program for vidofludimus calcium includes twin studies evaluating efficacy, safety, and tolerability against placebo[123]. - Immunic is exploring potential next steps for vidofludimus calcium in ulcerative colitis and other inflammatory bowel disease indications[137]. - The company is focused on developing new molecules that address biologically relevant immunological targets to elevate the standard of care for patients[131][132]. - IMU-381 has been selected as a development candidate for gastrointestinal diseases and is currently in preclinical testing[127]. - The company has deprioritized the development of izumerogant to focus resources on the advancing vidofludimus calcium and IMU-856 programs[144]. Income and Expenses - Research and development expenses increased by $5.5 million (32%) to $23.0 million for the three months ended March 31, 2023, primarily due to increased external development costs for the Phase 3 program of vidofludimus calcium[156]. - The company reported a 216% increase in total other income to $2.0 million for the three months ended March 31, 2023, driven by a research allowance and higher interest income[156]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[146]. - For the three months ended March 31, 2023, operating activities used $19.5 million in cash, primarily due to a net loss of $25.3 million[172]. - The company reported a net cash provided by investing activities of $5.3 million during the three months ended March 31, 2023, mainly from the sale of time deposits[174]. - Financing activities generated $51,000 in cash during the three months ended March 31, 2023, compared to $29.6 million in the same period of 2022[175]. Strategic Collaborations - Immunic is evaluating potential strategic collaborations to enhance the commercialization potential of its product candidates[137].