Immunic(US:IMUX)2024-11-07 12:04Financial Position - Immunic has an accumulated deficit of approximately $486.2 million as of September 30, 2024, compared to $410.9 million as of December 31, 2023[140]. - As of September 30, 2024, Immunic had cash and cash equivalents of approximately $59.1 million, which is insufficient to fund operations for at least twelve months without raising additional capital[142]. - The company has raised net cash of approximately $430.9 million from private and public offerings since inception[142]. - The company reported a net loss of $75.3 million for the nine months ended September 30, 2024, compared to a net loss of $72.0 million in the same period of 2023, indicating a 5% increase in losses[180]. - The accumulated deficit increased to approximately $486.2 million as of September 30, 2024, up from $410.9 million as of December 31, 2023[180]. - The company anticipates significant ongoing expenses and increasing operating losses as it continues the development of its product candidates and adds necessary personnel[181]. - Future capital requirements will depend on various factors, including the timing of regulatory submissions and the costs associated with clinical trials and commercialization activities[197]. - The company does not expect to achieve revenue from product sales prior to utilizing all net proceeds from public and private offerings to date[198]. - The cost of debt financing has increased due to rising interest rates over the past few years, which may affect future financing options[198]. - The company has not entered into any off-balance sheet arrangements or financial collaborations as of September 30, 2024[206]. Research and Development - The ongoing Phase 3 ENSURE program for vidofludimus calcium in relapsing multiple sclerosis (RMS) includes twin studies evaluating efficacy, safety, and tolerability[128]. - Positive interim data from the Phase 2 CALLIPER trial of vidofludimus calcium was announced on October 9, 2023, with top-line data expected in April 2025[128]. - IMU-856 has shown positive effects in a Phase 1b clinical trial for celiac disease, demonstrating safety and improvement in key dimensions of the disease[132]. - The company is preparing for Phase 2 testing of IMU-856 in patients with ongoing active celiac disease despite a gluten-free diet[132]. - The company has spent approximately $356.5 million on research and development expenses since its inception in March 2016, with a significant portion allocated to vidofludimus calcium[163]. - Research and development expenses increased by $1.6 million to $21.4 million for the three months ended September 30, 2024, compared to the same period in 2023, primarily due to increased external development costs[172]. - Research and development expenses decreased by $5.5 million to $58.4 million for the nine months ended September 30, 2024, compared to $63.9 million in the same period of 2023, reflecting a 9% decline[175]. - The company announced a positive outcome of an interim analysis of the Phase 3 ENSURE program for vidofludimus calcium, confirming that predetermined futility criteria were not met[158]. - The first patient was enrolled in a Phase 2 clinical trial of vidofludimus calcium for post-COVID syndrome, sponsored by Goethe University Frankfurt[155]. Financing Activities - The first tranche of a private placement raised $80 million at a price of $1.43 per share, closing on January 8, 2024[144]. - The second tranche of the private placement is conditional on the release of topline data from the Phase 2b clinical trial of vidofludimus calcium, expected around April 2025[144]. - The January 2024 Financing resulted in gross proceeds of approximately $80 million for the first tranche, with potential total gross proceeds ranging from $80 million to $240 million if all tranches are completed[146]. - The January 2024 Financing could yield total gross proceeds of up to $240 million, with the first tranche generating $80 million at a price of $1.43 per share[192][194]. - The net cash provided by financing activities was $74.4 million during the nine months ended September 30, 2024, mainly from the January 2024 Financing[205]. Expenses - General and administrative expenses rose by $0.6 million to $4.4 million for the three months ended September 30, 2024, mainly due to increased personnel expenses[173]. - General and administrative expenses increased by $2.1 million to $14.0 million for the nine months ended September 30, 2024, representing a 17% increase from $11.9 million in 2023[176]. - Other income increased by $0.5 million during the three months ended September 30, 2024, primarily due to increased research and development tax incentives[174]. Currency Impact - A 10% adverse change in foreign currency exchange rates could have resulted in an increase of approximately $50,000 in net current liabilities as of September 30, 2024[215]. - A 10% change in foreign currency exchange rates for the nine months ended September 30, 2024 would have impacted the company's net loss by approximately $5.8 million[215].