Financial Performance - Climb Bio, Inc. reported net losses of $8.7 million and $29.4 million for the three and six months ended June 30, 2025, respectively, with an accumulated deficit of $259.3 million as of the same date[94]. - The company has not generated any revenue from product sales since inception and may continue to incur operating losses for the foreseeable future[95]. - Net loss for Q2 2025 was $8.7 million, a significant improvement from a net loss of $54.9 million in Q2 2024, reflecting a reduction of $46.2 million[113]. - Net cash used in operating activities for the first half of 2025 was $26.6 million, compared to $2.5 million in the same period of 2024[128]. - The company has not generated any revenue from product sales and continues to incur net losses, indicating a reliance on external funding for operations[125]. Research and Development - The company received FDA clearance for a Phase 2 clinical trial of budoprutug in primary membranous nephropathy (pMN), with a previous Phase 1b trial showing 60% of patients achieving complete remission of proteinuria[91]. - Budoprutug is being developed for three distinct opportunity sets in immune-mediated diseases, including pMN, immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE)[90]. - Climb Bio, Inc. anticipates initiating a Phase 1 clinical trial for the subcutaneous formulation of budoprutug in healthy volunteers in Australia, with initial clinical data expected in the first half of 2026[91]. - The company is developing CLYM116, a preclinical stage anti-APRIL monoclonal antibody, with preclinical data expected in September 2025 and an IND submission anticipated in the second half of 2025[92]. - Research and development expenses increased from $1.0 million in Q2 2024 to $6.6 million in Q2 2025, primarily due to a $4.5 million increase for the budoprutug program[114]. - For the six months ended June 30, 2025, research and development expenses rose to $23.9 million from $2.1 million in the same period of 2024, driven by costs associated with the budoprutug and CLYM116 programs[120]. Acquisitions and Agreements - Climb Bio, Inc. acquired Tenet Medicines, Inc. for $41.9 million, with total acquisition costs amounting to $52.8 million, including transaction costs[98]. - The company entered into the Mabworks Agreement, making an upfront cash payment of $9.0 million for rights to develop CLYM116 outside of Greater China[99]. - The company has obligations under asset purchase and license agreements that include milestone and royalty payments contingent on future events[140]. Operational and Financial Outlook - The company expects its research and development expenses to increase substantially as it conducts ongoing clinical trials and preclinical studies[103]. - Climb Bio, Inc. has sufficient cash, cash equivalents, and marketable securities to fund planned operations through 2027, although this estimate is based on assumptions that may prove incorrect[97]. - The company anticipates that existing cash and marketable securities will be sufficient to fund operations through 2027, although future funding requirements may arise[134]. - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $187.4 million[125]. General and Administrative Expenses - General and administrative expenses increased from $5.6 million in the first half of 2024 to $9.8 million in the first half of 2025, mainly due to higher personnel-related expenses[122]. External Factors and Risks - The company faces potential delays in clinical trials due to global events, macroeconomic conditions, and supply chain disruptions[137]. - Inflationary pressures are impacting salaries, wages, and costs of goods and transportation, including tariffs and trade restrictions[137]. - The company is unable to estimate the timing or likelihood of achieving milestones or generating future product sales under its agreements[140]. Operational Enhancements - The company is enhancing operational systems and hiring personnel to support the development of its product candidates[137]. - The company has entered into contracts with CROs and CDMOs for clinical trials, which do not contain material minimum purchase commitments[138]. Interest Income - Interest income for Q2 2025 was $2.2 million, up from $1.5 million in Q2 2024, attributed to higher invested balances[117]. Lease Obligations - Remaining fixed lease payments for office space in Wellesley Hills, Massachusetts total $0.4 million through December 2026, with an option for an additional $0.3 million if extended[139]. Accounting Policies - The company is classified as an emerging growth company and can delay adopting new accounting standards until they apply to private companies[144]. - The company has not reported any material changes to its critical accounting policies during the three or six months ended June 30, 2025[142].
Eliem Therapeutics(ELYM) - 2025 Q2 - Quarterly Report