Financial Performance - For the three and nine months ended September 30, 2025, the net losses were $7.1 million and $26.7 million, respectively, compared to $15.2 million and $47.2 million for the same periods in 2024[108]. - The net loss for Q3 2025 was $7.1 million, an improvement from a net loss of $15.2 million in Q3 2024, while the nine-month net loss decreased to $26.7 million from $47.2 million[142]. - Interest income for Q3 2025 was $0.5 million, down from $1.3 million in Q3 2024, and for the nine months, it decreased to $2.1 million from $4.3 million[140]. - The company has incurred operating losses since inception and expects to continue incurring significant expenses and losses in the foreseeable future[108]. - The accumulated deficit as of September 30, 2025, was $454.1 million, indicating ongoing financial challenges[142]. Revenue and Collaborations - The company has not recorded any revenue from product sales, with all revenue derived from collaborations with Toray, Genmab, and Innovent[106]. - Collaboration revenue for Q3 2025 was $2.2 million, up from $1.1 million in Q3 2024, while nine-month revenue decreased to $5.2 million from $7.7 million in the same period[135]. - The company expects collaboration revenue to fluctuate based on the timing and outcome of development activities and payments from partners[121]. Expenses and Cost Management - Research and development expenses for Q3 2025 were $6.5 million, down from $13.8 million in Q3 2024, and for the nine months, expenses decreased to $23.5 million from $45.7 million[136]. - General and administrative expenses for Q3 2025 were $3.3 million, a decrease from $3.8 million in Q3 2024, and for the nine months, expenses decreased to $10.7 million from $14.5 million[138]. - The restructuring plan announced in May 2024 resulted in a workforce reduction of approximately 50 employees, or 50% of the workforce, with estimated charges of $3.6 million[104]. - A new restructuring plan was announced on October 1, 2025, to reduce operating expenses, including a further workforce reduction of approximately 20 employees, with estimated pre-tax charges of $1.5 million to $2.0 million[110]. Cash Flow and Funding - The company reported a net cash used in operating activities of $32.7 million for the nine months ended September 30, 2025, compared to $46.9 million for the same period in 2024[145]. - As of September 30, 2025, the company had cash and cash equivalents of $38.8 million, which is expected to fund operations into 2027[142]. - Net cash provided by investing activities was $43.2 million for the nine months ended September 30, 2025, compared to $45.3 million for the same period in 2024[146]. - The net cash provided by investing activities in 2025 included $59.5 million in maturities of marketable securities, offset by $17.2 million in purchases of marketable securities[146]. - Net cash provided by financing activities was $14,000 for the nine months ended September 30, 2025, compared to $0.1 million in 2024[147]. - Existing cash, cash equivalents, and marketable securities may be sufficient to fund operations into 2027, but there is substantial doubt about the company's ability to continue as a going concern[148]. - The company will need to raise additional capital to continue advancing its programs, with primary uses of cash including funding clinical trials and employee salaries[150]. - Future capital requirements will depend on various factors, including the ability to generate revenue from product sales and the success of collaborations[151]. - The company may finance cash needs through equity or debt financings, but there is a risk of dilution for existing stockholders[151]. Research and Development - The company is developing BDC-4182, a next-generation Boltbody™ ISAC targeting claudin 18.2, with ongoing Phase 1 trials[102]. - BDC-3042, a dectin-2 agonist antibody, received IND clearance in July 2023, and the first patient was dosed in October 2023[103]. - The company has established a wholly-owned subsidiary in Australia to enhance its research and development capabilities in the region[107]. - The company anticipates continuing to incur research and development expenses as product candidates in later stages generally have higher costs[126]. - Future clinical development costs may vary significantly based on multiple factors, including trial costs and patient participation rates[130]. - Significant costs are associated with clinical trials and manufacturing product candidates, which are expected to grow as development progresses[150]. - The company faces uncertainties regarding the timing and costs of regulatory reviews and market acceptance of approved products[153]. Accounting Policies - There have been no material changes to critical accounting policies and estimates since the last annual report[156].
Bolt Biotherapeutics(BOLT) - 2025 Q3 - Quarterly Report