Immunic(US:IMUX)2025-11-13 12:17Financial Performance - As of September 30, 2025, Immunic, Inc. has an accumulated deficit of approximately $589.3 million, up from $511.4 million as of December 31, 2024[176]. - The company has incurred operating losses since its inception in 2016, with significant expenses expected to continue as product candidates are developed[177]. - The net loss for the three months ended September 30, 2025, was $25.6 million, a 5% increase from a net loss of $24.4 million in the same period in 2024[217]. - For the nine months ended September 30, 2025, the company reported a net loss of $77.9 million, with cash used in operating activities amounting to $66.5 million, compared to a net loss of $75.3 million and cash used of $61.8 million for the same period in 2024[249][250]. - The company has not generated any revenue from product sales and anticipates needing substantial additional funding for ongoing operations and clinical trials[244][245]. - The company is facing substantial doubt about its ability to continue as a going concern without raising additional capital[228]. Clinical Trials and Development - The Phase 3 ENSURE program for vidofludimus calcium in relapsing multiple sclerosis (RMS) has enrolled 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2, with top-line data expected by the end of 2026[165]. - Positive interim data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) showed substantial reductions in confirmed disability progression and improvements in disability endpoints[166]. - The ongoing development of IMU-856 is aimed at treating gastrointestinal diseases, with positive Phase 1b trial results indicating improvements in celiac disease symptoms and gut architecture[169]. - The company is focused on executing the ongoing Phase 3 ENSURE clinical trials and preparing for additional clinical testing of IMU-856[175]. - Long-term data from the Phase 2 EMPhASIS trial showed that vidofludimus calcium was well-tolerated for treatment durations of up to 5.5 years, with an annualized discontinuation rate of approximately 6.4% among 182 patients[180]. - The Phase 3 ENSURE trials for vidofludimus calcium completed enrollment with a total of 2,221 patients across two trials, with top-line data expected by the end of 2026[185]. - The Phase 2 CALLIPER trial demonstrated that vidofludimus calcium reduced the relative risk of 24-week CDW events in the overall PMS patient population compared to placebo[187]. Financial Position and Liquidity - Immunic has raised approximately $496.3 million from various offerings since inception, but as of September 30, 2025, it has only $35.1 million in cash and cash equivalents, raising concerns about liquidity[178]. - The company may seek additional funding through debt, equity financing, or product licensing to meet long-term liquidity needs[227]. - The company filed a shelf registration statement allowing for the offering of up to $250 million in various securities, with $342.2 million available as of September 30, 2025, after previous offerings[229]. - The company raised gross proceeds of $5.1 million from the April 2025 Offering, selling 5,666,667 shares at $0.90 per share, with net proceeds of approximately $4.7 million after expenses[234][236]. - The May 2025 Offering generated approximately $65 million in gross proceeds, with potential additional proceeds of up to $130 million if warrants are fully exercised[240]. - The company has incurred approximately $441.2 million in research and development expenses since its inception in March 2016, as of September 30, 2025[208]. Strategic Initiatives - Immunic is exploring options for further development of certain assets, including potential spin-offs and licensing transactions[171]. - The company is evaluating potential strategic collaborations to enhance the commercialization of its product candidates[181]. - Immunic's strategy includes maximizing the potential of its development programs by addressing high unmet medical needs and exploring additional indications for its product candidates[174]. Safety and Efficacy - Vidofludimus calcium has shown a favorable safety and tolerability profile, having been tested in approximately 2,700 human subjects across various trials[167]. - The company reported a favorable safety profile for vidofludimus calcium, with no new safety signals identified during the trials[190]. - IMU-856 showed a dose-dependent increase of GLP-1 levels in celiac disease patients, indicating potential for weight management treatment[191]. - The cumulative exposure in the EMPhASIS OLE period totaled approximately 952 treatment years, reinforcing the drug's long-term safety and tolerability[184]. Regulatory and Compliance - The company received a Notice of Allowance for a patent covering dose strengths of vidofludimus calcium for the treatment of primary progressive multiple sclerosis (PMS), expected to provide protection until 2041[182]. - The company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance period until December 24, 2025[201]. Operational Expenses - Research and development expenses for the three months ended September 30, 2025, decreased by 6% to $20.0 million compared to $21.4 million in the same period in 2024[217]. - General and administrative expenses increased by 37% to $6.0 million for the three months ended September 30, 2025, compared to $4.4 million in the same period in 2024[218]. - Research and development expenses for the nine months ended September 30, 2025, increased by 8% to $58.4 million compared to $62.9 million in the same period in 2024[221]. Currency and Inflation Impact - A hypothetical 10% adverse change in foreign currency exchange rates could result in an increase of approximately $1.4 million in net current liabilities as of September 30, 2025[263]. - A 10% change in foreign currency exchange rates for the nine months ended September 30, 2025, would have impacted the company's net loss by approximately $6.1 million, primarily due to fluctuations in the Euro[263]. - The company experienced a general increase in costs due to global inflation, but it did not have a material impact on the results of operations for the periods presented[264]. - The company has not entered into any foreign currency hedging transactions or derivative financial transactions to mitigate foreign currency exchange risk[261].