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 for the same period in 2024, reflecting an increase of $3.9 million[118]. - 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 the same period 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 the same period in 2024[132]. - Research and development expenses for the nine months ended September 30, 2025, were $33.0 million, up from $8.4 million in 2024, primarily due to increased costs for the budoprutug and CLYM116 programs[125]. - General and administrative expenses for the nine months ended September 30, 2025, increased by $4.5 million to $15.6 million, largely due to a $3.1 million rise in personnel-related expenses[127]. Clinical Development - The company received FDA clearance for a Phase 2 clinical trial of budoprutug in primary membranous nephropathy (pMN), where 60% of patients in a prior trial achieved complete remission of proteinuria[93]. - Climb Bio is also advancing budoprutug in clinical trials for immune thrombocytopenia (ITP) and systemic lupus erythematosus (SLE), with initial data expected in the second half of 2026 for both indications[94][95]. - The company is developing CLYM116, an anti-APRIL monoclonal antibody, which has shown improved bioavailability and prolonged exposure compared to a first-generation counterpart[97]. - The company has paused the development of its Kv7 program, previously focused on neuronal excitability disorders, while seeking a partner for further development[98]. Acquisitions and Agreements - The company acquired Tenet Medicines, Inc. for $41.9 million in common stock, with total acquisition costs amounting to $52.8 million, including transaction costs[103]. - Climb Bio entered into the Mabworks Agreement, making an upfront payment of $9.0 million for rights to develop CLYM116 outside Greater China, with additional milestone payments expected[104]. - The company has obligations under an asset purchase agreement with Acelyrin, which includes milestone and royalty payments contingent on future events[145]. Financial Position and Funding - Climb Bio's cash, cash equivalents, and marketable securities are estimated to fund operations through 2027, but future financing may be required if capital resources are depleted sooner than anticipated[102]. - 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 need to finance operations through equity offerings or debt financings, which could dilute stockholder ownership[141]. Expenses and Cost Management - 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]. - 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 is subject to risks related to biopharmaceutical development, which may lead to unforeseen expenses and delays[140]. - The company may face inflationary pressures affecting salaries, goods, and transportation costs, impacting overall expenses[142]. - The company has no material minimum purchase commitments in contracts with third parties for clinical trials and manufacturing services[143]. Compliance and Accounting - The company is classified as an emerging growth company and can delay adopting new accounting standards until they apply to private companies[149]. - The company’s financial statements are prepared in accordance with U.S. GAAP, requiring estimates that could differ materially from actual results[146].
Climb Bio, Inc(CLYM) - 2025 Q3 - Quarterly Report