Financial Performance - The company reported net losses of $27,285,328 and $24,744,620 for the years ended December 31, 2024 and 2023, respectively, and $12,266,429 and $14,868,278 for the six months ended June 30, 2025 and 2024, respectively[113]. - As of June 30, 2025, the company had an accumulated deficit of $144,646,278[113]. - The company has incurred significant operating losses and expects to continue incurring substantial expenses as it develops elraglusib and seeks regulatory approval[113][114]. - Total operating expenses for the three months ended June 30, 2025, were $5,968,877, an increase of $533,428 compared to $5,435,449 in 2024[131]. - Net loss for the three months ended June 30, 2025, was $5,949,405, a decrease of $622,814 compared to a net loss of $6,572,219 in 2024[131]. - For the six months ended June 30, 2025, total operating expenses were $12,334,461, a decrease of $874,242 from $13,208,703 in 2024[137]. - The company reported a net loss of $12,266,429 for the six months ended June 30, 2025, which was offset by non-cash stock-based compensation expense of $2,704,372[154]. - The company anticipates an increase in general and administrative expenses in the future due to operational expansion and increased headcount[126]. Cash Position and Financing - As of June 30, 2025, the company had cash and cash equivalents of $6,492,656, which are expected to be insufficient to meet operational and capital requirements beyond October 2025 without additional capital[117]. - The company entered into a common stock purchase agreement allowing it to sell up to $50 million of newly issued shares over a 36-month period, with net proceeds of $2,148,506 received for 256,429 shares sold under this facility[115]. - The company received net proceeds of $4,621,546 from a private placement of common stock and warrants in June 2025[145]. - The company anticipates that its existing cash and cash equivalents will not satisfy operational and capital requirements beyond October 2025, necessitating additional financing[148][149]. - During the six months ended June 30, 2025, the company provided net cash of $6,643,535 from financing activities, compared to $5,314,270 in the same period of 2024[153]. Clinical Development - The Actuate-1801 trial enrolled 286 patients with metastatic pancreatic ductal adenocarcinoma, showing a median overall survival of 10.1 months for the elraglusib/GnP combination versus 7.2 months for GnP alone, representing a 37% reduction in the risk of death[104][105]. - The 12-month overall survival rate was 44.1% for the elraglusib/GnP group compared to 22.3% for the GnP group, with a p-value of 0.0005 indicating statistical significance[105]. - The company plans to advance the clinical program for elraglusib in Ewing sarcoma towards a Phase 2 study in 2026, subject to funding availability[109]. - The company has developed oral dosage forms of elraglusib and plans to conduct a Phase 1 study to identify the maximum tolerated dose for the Elraglusib Oral Tablet[110]. - The topline data from the Actuate-1801 trial indicated improved overall response rates of 29.0% for elraglusib/GnP compared to 21.8% for GnP alone[107]. - The company is continuing to invest in clinical trials for elraglusib, with costs dependent on the size, number, and length of these trials[151]. Operating Expenses - Research and development expenses decreased by $1,608,000 to $2,764,805 for the three months ended June 30, 2025, primarily due to lower external clinical trial expenses[134]. - General and administrative expenses increased by $2,141,428 to $3,204,072 for the three months ended June 30, 2025, mainly driven by a rise in personnel-related expenses[135]. - Research and development expenses for the six months ended June 30, 2025, were $5,985,124, down $5,248,111 from $11,233,235 in 2024[138]. - General and administrative expenses for the six months ended June 30, 2025, increased by $4,373,869 to $6,349,337, largely due to higher personnel-related expenses[141]. - The company expects stock-based compensation expense to increase in future periods due to continued equity-based awards[165]. Other Financial Information - Interest income for the three months ended June 30, 2025, was $24,534, an increase of $15,889 compared to $8,645 in 2024[131]. - The company recorded a change in estimated fair value of warrant liability of $240,339 for the three months ended June 30, 2024, which is included in other income (expense)[136]. - The company recognized an increase in the fair value of warrant liability of $272,854 for the six months ended June 30, 2024[147]. - The company incurred a loss of $400,000 on the issuance of Related Party Convertible Notes Payable for the six months ended June 30, 2024[147]. - The company currently has no off-balance sheet arrangements as defined by SEC regulations[166]. - The company is classified as an emerging growth company under the JOBS Act, allowing for an extended transition period for new accounting standards[168]. - The company qualifies as a smaller reporting company, enabling it to utilize scaled disclosures as long as certain revenue and stock thresholds are met[169]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its smaller reporting company status[170].
Actuate Therapeutics,Inc(ACTU) - 2025 Q2 - Quarterly Report