Core Insights - Actuate Therapeutics, Inc. has completed patient enrollment in a Phase 2 trial for elraglusib in combination with FOLFIRINOX and losartan for untreated metastatic pancreatic adenocarcinoma (mPDAC) [1][2][3] - The trial enrolled 56 treatment-naïve mPDAC patients, focusing on safety, tolerability, and progression-free survival [2] - Initial data from the trial indicates enhanced clinical activity of elraglusib when combined with FOLFIRINOX and losartan [3][7] - The final results from the trial are anticipated in 2026 [3][7] Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on therapies for high-impact, difficult-to-treat cancers [4] - The lead investigational drug, elraglusib, is a novel GSK-3β inhibitor targeting pathways that promote tumor growth and resistance to conventional therapies [4] - Elraglusib is designed to enhance anti-tumor immunity by inhibiting NF-kB and regulating immune checkpoints [4] Research Collaboration - The trial is led by Dr. Colin Weekes at Massachusetts General Hospital, with support from the Lustgarten Foundation and participation from other institutions [1][3] - Massachusetts General Hospital is noted for conducting the largest hospital-based research program in the U.S., with over $1 billion in annual research operations [5]

Core Insights - Actuate Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β) [1][4] - The company's lead investigational drug, elraglusib, targets molecular pathways involved in tumor growth and resistance to conventional cancer treatments, aiming to enhance anti-tumor immunity [4] Upcoming Investor Conferences - Actuate's President & CEO, Daniel Schmitt, will participate in the BIO CEO & Investor Conference on February 10, 2025, in New York, NY, which includes one-on-one meetings [2] - The company will also be present at the B. Riley Precision Oncology & Radiopharma Conference on February 28, 2025, in New York, NY, featuring a fireside chat and one-on-one meetings [3] Company Overview - Actuate Therapeutics is dedicated to developing therapies for challenging cancers, with elraglusib being a novel GSK-3β inhibitor that mediates anti-tumor immunity by inhibiting NF-kB and regulating immune checkpoints [4]

Core Insights - Actuate Therapeutics announced positive interim data from its Phase 2 trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) for treating metastatic pancreatic ductal adenocarcinoma (mPDAC) [1][2][3] Summary by Sections Trial Results - The trial met its primary endpoint with a 1-year survival rate of 43.6% in the elraglusib-GnP combination arm compared to 22.5% in the GnP control arm (p=0.002) [4] - Median overall survival (mOS) was 9.3 months for the elraglusib-GnP arm versus 7.2 months for the GnP arm, indicating a 37% reduction in risk of death (HR=0.63, p=0.016) [4] - Objective Response Rates (ORR) were 27.7% in the elraglusib-GnP arm compared to 20.5% in the GnP arm, while Disease Control Rates (DCR) were 42.6% versus 33.3% respectively [4] Patient Outcomes - As of the data cutoff on November 15, 2024, 38% of patients in the elraglusib-GnP arm were still alive compared to 19% in the control arm [4] - Notable patient outcomes included two patients with previously inoperable metastatic lesions showing significant reductions in target lesions, with one achieving a 100% reduction in total tumor burden after surgery [4] Safety Profile - The trial met its primary safety endpoint, with treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs) in the elraglusib-GnP arm being similar to those in the GnP arm, indicating a favorable risk-benefit profile [4][5] Future Plans - The company plans to engage with the FDA in the first half of 2025 to share topline data and discuss next steps, including a proposed Phase 3 registration trial [3][5]

Financial Performance - The company reported net losses of approximately $24.7 million and $20.2 million for the years ended December 31, 2023 and 2022, respectively, and $20.8 million and $17.1 million for the nine months ended September 30, 2024 and 2023, respectively [137]. - The company has incurred significant operating losses and negative cash flows from operations since inception, with expectations that these losses will continue to increase as development efforts progress [137]. - The net loss for the three months ended September 30, 2024, was $5,970,961, an improvement of $366,964 compared to a net loss of $6,337,925 in the same period of 2023 [161]. - For the nine months ended September 30, 2024, total operating expenses were $18,601,606, an increase of $1,242,958 compared to $17,358,648 in the same period of 2023 [172]. - The net cash used in operating activities for the nine months ended September 30, 2024, was $20,839,239, compared to a net loss of $17,132,466 for the same period in 2023 [192]. Funding and Capital Structure - The company completed its IPO on August 14, 2024, raising net proceeds of approximately $22 million from the issuance of 3,220,000 shares of common stock at an initial offering price of $8.00 per share [142]. - The Company issued 884,427 shares of common stock upon the conversion of Related Party Convertible Notes Payable at a conversion price of $6.40 per share, representing 80% of the IPO price of $8.00 per share [159]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $27,635,023, significantly higher than $4,134,516 for the same period in 2023 [194]. Cash Position - The company has cash and cash equivalents of approximately $13.5 million as of September 30, 2024, which is not expected to satisfy operational and capital requirements for the next twelve months [140]. - The company estimates that its existing cash and cash equivalents will not satisfy operational and capital requirements through twelve months from the issuance date of the financial statements [188]. Clinical Development - The company plans to conduct a Phase 1 study for the Elraglusib Oral Tablet to identify the maximum tolerated dose and recommended Phase 2 dose in patients with advanced, refractory adult cancers [135]. - The company is advancing a Phase 2 clinical trial for the treatment of metastatic pancreatic ductal adenocarcinoma and a Phase 1/2 clinical trial in refractory pediatric malignancies, including Ewing sarcoma [134]. - The company expects to incur significant expenses related to developing its commercialization capability to support product sales, marketing, and distribution if regulatory approval for elraglusib is obtained [137]. - The company expects to incur significant expenses and operating losses in the foreseeable future as it advances the clinical development of elraglusib [186]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $5,392,903, a decrease of $1,082,770 compared to $6,475,673 in the same period of 2023 [161]. - Research and development expenses decreased by approximately $2.0 million to $3,757,102 for the three months ended September 30, 2024, primarily due to fewer contracted studies and a decrease in external clinical trial expenses [163]. - General and administrative expenses increased by approximately $0.9 million to $1,635,801 for the three months ended September 30, 2024, mainly due to higher personnel-related expenses and increased professional fees [164]. - General and administrative expenses increased by approximately $1.3 million to $3,611,269 for the nine months ended September 30, 2024, compared to $2,296,143 for the same period in 2023 [176]. - Personnel-related expenses rose by approximately $0.4 million, primarily due to an increase in non-cash stock-based compensation [176]. - Professional and consulting fees increased by approximately $0.7 million, mainly due to search firm fees for adding new board members and increased legal fees [176]. Valuation and Fair Value - The fair value of common stock prior to the IPO was determined by the board of directors based on third-party valuations and various subjective factors [206]. - The company utilized the Black-Scholes valuation model for stock options, requiring inputs such as expected volatility and risk-free rate [204]. - The estimated fair value of Related Party Convertible Notes Payable was determined using valuation models with significant unobservable inputs, classified as Level 3 measurements [216]. - A loss of $400,000 was recorded on the issuance of Related Party Convertible Notes Payable during the nine months ended September 30, 2024, reflecting the difference between estimated fair value and gross proceeds [217]. - The fair value of financial instruments approximates their carrying amounts due to their short-term nature [211]. Company Classification - The company is classified as an emerging growth company, allowing it to take advantage of an extended transition period for new accounting standards [221]. - The company is also a smaller reporting company, which permits scaled disclosures as long as certain revenue and market capitalization thresholds are met [222]. Miscellaneous - The company has no off-balance sheet arrangements during the periods presented [219]. - The fair value of Redeemable Convertible Preferred Stock Warrants was subject to remeasurement until the earlier of exercise, conversion, or expiration [212].