Financial Performance - The company reported net losses of $8.9 million for Q3 2024, compared to $4.0 million for Q3 2023, and $65.5 million for the first nine months of 2024, compared to $31.5 million for the same period in 2023, indicating a significant increase in losses year-over-year [132]. - The company has an accumulated deficit of $221.5 million as of September 30, 2024, compared to $156.0 million as of December 31, 2023 [132]. - The net loss for the three months ended September 30, 2024, was $8.9 million, a 124.2% increase from a net loss of $4.0 million in the same period of 2023 [161]. - Total operating expenses for the nine months ended September 30, 2024, were $71.1 million, a 102.3% increase from $35.2 million in the same period of 2023 [166]. - Research and development expenses increased by 111.6% from $2.9 million for the three months ended September 30, 2023, to $6.1 million for the same period in 2024 [162]. - General and administrative expenses rose by 158.4% from $2.1 million for the three months ended September 30, 2023, to $5.5 million for the same period in 2024 [163]. - Acquired in-process research and development expense was $51.7 million for the nine months ended September 30, 2024, due to the acquisition completed on June 27, 2024 [167]. - General and administrative expenses decreased by 51.6% from $22.9 million for the nine months ended September 30, 2023 to $11.1 million for the nine months ended September 30, 2024 [169]. Cash and Funding - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $217.9 million, up from $106.8 million as of December 31, 2023, providing sufficient funds to support operations through 2027 [133]. - The company anticipates that its cash, cash equivalents, and marketable securities will be sufficient to fund operations through 2027 [172]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $10.0 million, consisting primarily of a net loss of $65.5 million [178]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $130.7 million, including $119.7 million from the issuance of common stock in a Private Placement [182]. - Net cash used in investing activities for the nine months ended September 30, 2024 was $67.7 million, primarily due to purchases of marketable securities [179]. - Future funding requirements will depend on various factors, including the timing and cost of research and development activities [173]. - The company may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures [175]. Clinical Development - In a Phase 1b clinical trial of budoprutug for primary membranous nephropathy (pMN), 60% of patients achieved complete remission of proteinuria, and complete B-cell depletion was observed in all patients [127][141]. - The FDA cleared the IND for budoprutug in systemic lupus erythematosus (SLE) in October 2024, with plans to initiate a Phase 1b clinical trial in the first half of 2025 [137][146]. - The company plans to initiate a Phase 2 clinical trial of budoprutug for immune thrombocytopenia (ITP) in the first half of 2025, pending IND clearance [129][146]. - Budoprutug was well-tolerated in clinical trials, with no drug-related serious adverse events reported, and no deaths among patients [143]. - The company plans to announce non-clinical data on the subcutaneous formulation of budoprutug in the first half of 2025 [149]. - The strategic focus includes developing budoprutug for IgG4-mediated diseases, IgG1-3 related diseases, and complex systemic diseases, with potential applications beyond current indications [140]. Acquisition Details - The company completed the acquisition of Tenet Medicines, Inc. on June 27, 2024, issuing 31,238,282 shares at $3.84 per share, raising approximately $120.0 million before expenses [131]. - The total cost of the asset acquisition of Tenet was $52.8 million, including $5.8 million in transaction costs and $5.0 million related to a loan settled upon closing [136].
Eliem Therapeutics(ELYM) - 2024 Q3 - Quarterly Report