Immunic(US:IMUX)2023-11-14 12:27Financial Position - As of September 30, 2023, Immunic has an accumulated deficit of approximately $389.3 million, up from $317.3 million as of December 31, 2022[131]. - The company has raised net cash of approximately $355.9 million from private and public offerings since inception, with cash and cash equivalents of approximately $59.7 million as of September 30, 2023[133]. - Cash and cash equivalents were approximately $59.7 million, insufficient to fund operations for the next twelve months without raising additional capital[170]. - As of September 30, 2023, total contractual obligations related to operating leases amounted to $1.595 million, with a present value of obligations at $1.451 million[186]. - The company has non-cancelable contractual obligations under development programs totaling approximately $5.1 million, expected to be paid over the next twelve months[186]. - Operating activities used $56.8 million in cash during the nine months ended September 30, 2023, compared to $50.0 million in 2022[180]. - Net cash provided by financing activities was $0.4 million for the nine months ended September 30, 2023, compared to $39.7 million for the same period in 2022[184]. - A hypothetical 10% adverse change in foreign currency exchange rates could decrease net current assets by approximately $1.3 million as of September 30, 2023[193]. - A 10% change in foreign currency exchange rates for the nine months ended September 30, 2023, would have impacted the net loss by approximately $6.3 million, primarily due to the euro[193]. - The company has not entered into any foreign currency hedging transactions or derivative financial transactions to mitigate foreign currency risk[191]. Clinical Development - Vidofludimus calcium (IMU-838) is in Phase 3 clinical development for multiple sclerosis (MS), with positive interim data from the Phase 2 CALLIPER trial showing a 6.7% reduction in serum NfL at 24 weeks compared to a 15.8% increase in placebo[136][137]. - The Phase 2 CALLIPER trial has completed enrollment with 467 patients, and top-line data is expected in April 2025[139]. - IMU-856 has shown positive effects in a Phase 1 clinical trial for celiac disease, demonstrating improvements in gut architecture and patient symptoms[126]. - Positive results from the Phase 1b clinical trial of IMU-856 showed improvements in gut architecture protection, symptom relief, biomarker response, and nutrient absorption in celiac disease patients[143]. - The Phase 3 ENSURE and Phase 2 CALLIPER clinical trial programs for vidofludimus calcium in multiple sclerosis (MS) are ongoing[140]. - Vidofludimus calcium demonstrated a 33.7% absolute improvement over placebo in achieving clinical remission at week 50 in the Phase 2b CALDOSE-1 trial for moderate-to-severe ulcerative colitis (UC)[148]. - The maintenance phase data of CALDOSE-1 confirms vidofludimus calcium's activity without chronic corticosteroid co-administration, indicating safety and tolerability[150]. Financial Performance - The company reported a net loss of $22.8 million for the three months ended September 30, 2023, compared to a net loss of $21.2 million for the same period in 2022, reflecting a 7% increase in losses[162]. - Total operating expenses increased by 17% to $23.6 million for the three months ended September 30, 2023, compared to $20.1 million for the same period in 2022[162]. - Research and development expenses increased by 20% to $19.8 million for the three months ended September 30, 2023, compared to $16.5 million for the same period in 2022[162]. - Total operating expenses for the nine months ended September 30, 2023, increased by 22% to $75.8 million compared to $62.2 million in 2022[165]. - Research and development expenses rose by 27% to $63.9 million, driven by a $10.1 million increase in external development costs for the Phase 3 clinical program of vidofludimus calcium[165]. - The net loss for the nine months ended September 30, 2023, was $72.0 million, a 13% increase from the $63.9 million loss in 2022[165]. Strategic Focus - Immunic has no products approved for commercial sale and has incurred operating losses since its inception in 2016, with significant expenses expected to continue[131][132]. - The company is exploring options to support further development of its antiviral portfolio, including potential spin-offs and licensing transactions[128]. - Immunic's strategy focuses on developing new molecules targeting immunological conditions with high unmet needs, leveraging its research infrastructure in Germany and Australia[134]. - The company is deprioritizing the izumerogant development program to focus resources on the advancing vidofludimus calcium and IMU-856 programs[151]. Other Financial Information - Other income increased by $1.9 million during the three months ended September 30, 2023, primarily due to a decrease in foreign exchange losses and an increase in interest income[164]. - Other income increased by $5.6 million, mainly from a $2.2 million rise in interest income and a $3.2 million decrease in foreign exchange losses[167]. - There were no significant changes in critical accounting policies or estimates during the first nine months of 2023[188]. - The company has not entered into any off-balance sheet arrangements as of September 30, 2023[185]. - Inflation has led to a general increase in costs, but it has not materially impacted the company's results of operations[194].