Financial Performance - Total revenue for the three months ended March 31, 2025 was $0, a decrease from $0.7 million recognized in the same period of 2024 [109]. - Net loss for the three months ended March 31, 2025 was $18.1 million, compared to a net loss of $16.2 million in the same period of 2024 [108]. - Interest income decreased to $1.0 million for the three months ended March 31, 2025, down from $2.0 million in 2024, attributed to lower cash equivalents held [112]. - Interest expense increased to $1.3 million for the three months ended March 31, 2025, compared to $1.0 million in 2024, due to a higher effective interest rate under the K2HV Loan Agreement [113]. - The accumulated deficit as of March 31, 2025 was $432.7 million, with expectations of continued substantial losses in the foreseeable future [115][118]. - Net cash used in operating activities for Q1 2025 was $18.9 million, an increase of $3.7 million compared to $15.3 million in Q1 2024, primarily due to decreased revenue and increased interest expenses [137]. - The company reported a net decrease in cash, cash equivalents, and restricted cash of $18.9 million for the three months ended March 31, 2025 [136]. Research and Development - The company reported external development costs totaling $6,927,000 for the three months ended March 31, 2025, compared to $6,637,000 for the same period in 2024, reflecting an increase in investment in product candidates [98]. - Research and development expenses increased to $13.1 million for the three months ended March 31, 2025, compared to $12.9 million in 2024, primarily due to a $1.0 million increase in clinical trial costs [110]. - Research and development expenses are expected to increase substantially as the company progresses clinical trials and continues preclinical development of multiple product candidates [98]. - WTX-124 is currently in a Phase 1/1b clinical trial, with a recommended dose of 18 mg administered intravenously every two weeks, and interim data is expected to be presented in the second half of 2025 [87]. - WTX-330 completed Phase 1 clinical trials in Q1 2025, with updated safety and efficacy data presented in November 2024, and a Phase 1b/2 trial initiated in Q2 2025 [88]. - The company is developing WTX-712, WTX-518, and WTX-921, with WTX-712 showing a unique mechanism that activates tumor-specific T lymphocytes [89]. - The PREDATOR platform is being utilized to develop conditionally activated immune cell engagers, with the first INDUCER development candidate expected to be nominated in Q2 2025 [92]. Collaboration and Funding - The company has entered into a global collaboration with Jazz Pharmaceuticals for the development of the JZP898 INDUKINE molecule, with Jazz responsible for commercialization activities [93]. - The company has received $20.0 million in payments from Jazz under the Collaboration Agreement and is eligible for up to $1.255 billion in additional milestone payments [130]. - The company anticipates needing substantial additional funding to support ongoing operations and growth strategies [119]. - The company anticipates needing additional funding to complete the development of product candidates WTX-124 and WTX-330, as current cash resources are insufficient [133]. - The K2HV Loan Agreement provides up to $60.0 million in term loans, with $30.0 million received at closing and additional tranches available based on certain milestones [122]. - The term loan matures on May 1, 2028, with an interest rate of at least 10.3% or a variable rate based on the prime rate plus 1.8% [123]. - The company may consider equity or debt financing to fund operations, which could lead to dilution for shareholders or impose operational restrictions [134]. Administrative Expenses - General and administrative expenses decreased to $4.9 million for the three months ended March 31, 2025, down from $5.0 million in 2024, mainly due to a reduction in professional services fees [111]. - The company expects general and administrative expenses to increase as personnel headcount grows to support research and development activities [103]. Operational Outlook - Future revenue generation will depend on achieving various development and regulatory milestones, with potential fluctuations based on product sales and collaborations [96]. - The company’s operating expenditures will depend on the progress and costs associated with clinical trials and product development [132]. - The estimated total base rent payments for the office and laboratory lease expiring in May 2030 are approximately $12.7 million [142]. - The company did not sell any shares under the ATM Offering during the three months ended March 31, 2025, after raising $20.2 million in the previous period [139].
Werewolf Therapeutics(HOWL) - 2025 Q1 - Quarterly Report