Financial Performance - The company reported a net loss of $63.1 million for the nine months ended September 30, 2025, compared to a net loss of $49.3 million for the same period in 2024, resulting in an accumulated deficit of $309.8 million[123]. - Net loss for the three months ended September 30, 2025, was $21.5 million, compared to a net loss of $17.5 million in 2024, an increase of $4.1 million[139]. - The net loss for the nine months ended September 30, 2025, was $63.1 million, up from a net loss of $49.3 million in 2024, indicating a deterioration in financial performance[155][156]. - Other income for the nine months ended September 30, 2025, was $4.8 million, compared to an expense of $0.3 million in 2024, a $5.0 million improvement[147]. - The company expects to incur significant operating losses for the foreseeable future as it advances its product candidates through clinical development[123]. Revenue and Financing - The company has raised a total of $222.4 million through various financing activities, including $162.3 million from its IPO, where 13,920,000 shares were sold at $12.00 per share[121]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained, which may take several years[122]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $0.1 million, a sharp decline from $162.3 million in 2024, primarily due to the absence of IPO proceeds[159][160]. Research and Development - Research and development expenses increased to $17.6 million for the three months ended September 30, 2025, up from $13.5 million in 2024, representing a $4.1 million increase[139]. - Research and development expenses for the nine months ended September 30, 2025, totaled $52.5 million, compared to $37.0 million in 2024, marking a $15.5 million increase[145]. Operating Expenses - General and administrative expenses rose to $5.3 million for the three months ended September 30, 2025, compared to $4.8 million in 2024, an increase of $0.5 million[140]. - General and administrative expenses for the nine months ended September 30, 2025, were $15.3 million, up from $12.3 million in 2024, an increase of $3.1 million[146]. - Total operating expenses for the three months ended September 30, 2025, were $22.9 million, up from $18.3 million in 2024, reflecting a $4.6 million increase[139]. - Total operating expenses for the nine months ended September 30, 2025, reached $67.9 million, compared to $49.3 million in 2024, reflecting an increase of $18.6 million[143]. Cash Flow and Investments - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $123.0 million, with an accumulated deficit of $309.8 million[149]. - The company expects existing cash and investments to fund operations into the second quarter of 2027[149]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $62.0 million, compared to $40.4 million in 2024, reflecting an increase of 53.5%[155][156]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $47.4 million, a significant improvement compared to a net cash outflow of $119.5 million in 2024[157][158]. Product Development and Regulatory Status - The FDA has granted Fast Track Designation to the company's lead product candidate, AlloNK, for the treatment of refractory rheumatoid arthritis (RA) in combination with rituximab[119]. - As of November 2025, 32 patients with autoimmune diseases have been treated with AlloNK and monoclonal antibodies across various trials[117]. - The company plans to share initial safety and translational data for over 20 patients treated with AlloNK and monoclonal antibodies in mid-November 2025[119]. - The company plans to conduct FDA regulatory interactions in the first half of 2026 to align on the potential pivotal trial design for AlloNK in refractory RA[119]. Lease Obligations - The company has future remaining operating lease payments of $13.5 million as of September 30, 2025, with $0.6 million due before December 31, 2025[168]. - The Executive Drive Lease has aggregate payments of approximately $2.8 million, with a term through December 2025[162]. - The Morehouse Lease includes aggregate payments of approximately $23.2 million over an initial term of 88 months, with a tenant improvement allowance of $12.3 million[164]. - The company entered into a lease agreement for a warehouse and storage facility with aggregate payments of approximately $0.5 million, commencing March 1, 2025[167]. Miscellaneous - The company has incurred zero license and development support revenue during the three months ended September 30, 2025[125]. - As of September 30, 2025, the company is unable to estimate the timing or likelihood of achieving milestone payments under collaboration agreements[169]. - The company has no off-balance sheet arrangements as defined by SEC rules[171].
Artiva Biotherapeutics, Inc.(ARTV) - 2025 Q3 - Quarterly Report