Financial Performance - Climb Bio, Inc. reported net losses of $12.9 million and $42.3 million for the three and nine months ended September 30, 2025, respectively, with an accumulated deficit of $272.2 million[99]. - Net loss for the three months ended September 30, 2025, was $12.9 million, compared to a net loss of $8.9 million in the same period of 2024, reflecting an increase of $3.9 million[118]. - For the nine months ended September 30, 2025, research and development expenses surged to $33.0 million from $8.4 million in 2024, with a $13.4 million increase attributed to the budoprutug program[125]. - General and administrative expenses for the nine months ended September 30, 2025, increased by $4.5 million to $15.6 million, mainly due to a $3.1 million rise in personnel-related expenses[127]. - Total operating expenses for the nine months ended September 30, 2025, were $48.6 million, a decrease of $22.5 million from $71.1 million in 2024[124]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $38.7 million, compared to $10.0 million in 2024[132]. - Interest income decreased from $2.8 million in Q3 2024 to $2.0 million in Q3 2025, primarily due to lower invested balances[121]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $175.8 million[130]. Research and Development - Climb Bio is developing budoprutug for three distinct immune-mediated diseases: pMN, immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE)[92]. - The company received FDA clearance for a Phase 2 clinical trial of budoprutug in primary membranous nephropathy (pMN), with 60% of patients achieving complete remission of proteinuria in a prior Phase 1b trial[93]. - Climb Bio anticipates significant increases in research and development expenses as it conducts ongoing clinical trials and studies[108]. - The company expects to have initial data from the Phase 1b/2a clinical trial in ITP in the second half of 2026[94]. - Budoprutug is designed to deplete CD19-positive B cells, potentially offering a disease-modifying approach for various immune-mediated diseases[91]. - CLYM116 is being developed for immunoglobulin A nephropathy (IgAN) and has shown improved bioavailability and prolonged exposure compared to first-generation therapies[97]. - Research and development expenses increased from $6.2 million in Q3 2024 to $9.1 million in Q3 2025, primarily due to a $2.7 million increase in costs for the budoprutug program[119]. Acquisitions and Agreements - Climb Bio acquired Tenet Medicines, Inc. for $41.9 million, with total acquisition costs amounting to $52.8 million, including transaction costs[103]. - The upfront payment for the Mabworks Agreement to develop CLYM116 was $9.0 million, with additional milestone payments and royalties expected[104]. - The company has obligations under an asset purchase agreement with Acelyrin, which includes milestone and royalty payments contingent on future events[145]. Future Funding and Financial Strategy - The company believes its existing cash, cash equivalents, and marketable securities will be sufficient to fund operations through 2027[139]. - Future funding requirements will depend on various factors, including the costs and progress of clinical trials for product candidates like budoprutug and CLYM116[142]. - The company may finance operations through equity offerings, debt financings, and collaborations, but may face dilution of stockholder ownership[140]. - The company may need to delay or limit product development if unable to raise additional funds when needed[141]. - The company is subject to risks related to unforeseen expenses and complications in the development of biopharmaceutical candidates[140]. General and Administrative Expenses - General and administrative expenses rose from $5.5 million in Q3 2024 to $5.8 million in Q3 2025, driven by higher personnel-related expenses of $0.8 million[120]. - The company has fixed lease payments of $0.4 million through December 2026, with an option to extend for an additional $0.3 million[144]. Accounting and Compliance - The company is classified as an emerging growth company and can delay adopting new accounting standards until certain revenue thresholds are met, specifically $1.235 billion[149]. - The company has not made material changes to its critical accounting policies during the three or nine months ended September 30, 2025[147].
Eliem Therapeutics(ELYM) - 2025 Q3 - Quarterly Report