Core Insights - Actuate Therapeutics, Inc. announced promising results from a Phase II study of elraglusib, showing a median overall survival of 18.6 months and 40% of patients alive at 2 years [1][5][6] Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for difficult-to-treat cancers, with elraglusib as its lead investigational drug targeting GSK-3β [8] Study Details - The Phase II study evaluated elraglusib in combination with platinum chemotherapy in patients with advanced, metastatic salivary gland cancers, including adenoid cystic carcinoma [3][7] - The study enrolled 32 patients, with a median progression-free survival of 6.4 months and 27% of patients progression-free at 1 year [5][11] Key Findings - Nuclear GSK-3β expression was significantly higher in responders (50%) compared to non-responders (2%), suggesting its potential as a biomarker for treatment response [3][11] - Among non-ACC patients receiving immune priming followed by cisplatin plus elraglusib, the response rate was 18%, with all responders showing elevated nuclear GSK-3β expression [4][6] Treatment Efficacy - The median overall survival for non-ACC patients was notably higher at 27.8 months, indicating a potential benefit of elraglusib in this subgroup [5] - The combination treatment was well tolerated, with no treatment-related deaths and a low discontinuation rate due to toxicity [11]

Actuate Therapeutics, Inc. (ACTU) closed the last trading session at $6.9, gaining 4.9% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $21.67 indicates a 214.1% upside potential.The average comprises three short-term price targets ranging from a low of $20.00 to a high of $25.00, with a standard deviation of $2.89. While the lowest estimate indicates an increase of 189.9% from the ...

Financial Performance - Actuate Therapeutics reported a net loss of $27,285,328 for the year ended December 31, 2024, compared to a net loss of $24,744,620 for 2023, indicating an increase in losses [126]. - The company has an accumulated deficit of $150,053,748 as of September 30, 2025, primarily due to research and development costs and general administrative expenses [126]. - The net loss for the three months ended September 30, 2025 was $5,407,470, a decrease of $563,491 compared to a net loss of $5,970,961 in 2024 [127]. - The net loss for the nine months ended September 30, 2025 was $17,673,899, an improvement of $3,165,340 compared to a net loss of $20,839,239 in 2024 [131]. - The company reported a net loss of $17,673,899 for the nine months ended September 30, 2025, compared to a net loss of $20,839,239 for the same period in 2024 [145]. - The company has incurred significant operating losses and negative cash flows from operations since inception, with expectations of continued losses as it advances clinical development of elraglusib and future product candidates [135]. - The company has substantial doubt regarding its ability to continue as a going concern due to ongoing losses and cash flow challenges [141]. Research and Development - The Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) showed a median overall survival (mOS) of 10.1 months for the elraglusib/GnP group compared to 7.2 months for the GnP group, representing a 37% reduction in the risk of death [106]. - The 12-month overall survival rate was 44.1% for the elraglusib/GnP group versus 22.3% for the GnP group, with a p-value of 0.0005 indicating statistical significance [107]. - The overall response rate (ORR) for the elraglusib/GnP group was 29.0%, compared to 21.8% for the GnP group [108]. - Actuate Therapeutics plans to advance elraglusib for the treatment of relapsed/refractory Ewing sarcoma (EWS) in a Phase 2 study in 2026, subject to funding availability [111]. - The company has developed oral dosage forms of elraglusib and plans to conduct a Phase 1 study for the Elraglusib Oral Tablet to identify the maximum tolerated dose [113]. - Actuate Therapeutics has submitted an amended investigational new drug (IND) application to the FDA and is seeking Breakthrough Therapy Designation (BTD) for elraglusib [109]. - The company anticipates significant increases in research and development expenses as it continues clinical trials and seeks regulatory approvals for elraglusib [117]. - The company is committed to ongoing clinical trials for elraglusib, with costs dependent on the size, number, and length of these trials [142]. Operating Expenses - For the three months ended September 30, 2025, total operating expenses were $5,472,378, a slight increase of $79,475 compared to $5,392,903 in 2024 [127]. - Research and development expenses decreased by $1,579,180 to $2,177,922 for the three months ended September 30, 2025, primarily due to lower external clinical trial expenses [128]. - General and administrative expenses increased by $1,658,655 to $3,294,456 for the three months ended September 30, 2025, mainly driven by a rise in personnel-related expenses [129]. - For the nine months ended September 30, 2025, total operating expenses were $17,806,839, a decrease of $794,767 from $18,601,606 in 2024 [131]. - Research and development expenses for the nine months ended September 30, 2025 were $8,163,046, down $6,827,291 from $14,990,337 in 2024 [132]. - General and administrative expenses for the nine months ended September 30, 2025 increased by $6,032,524 to $9,643,793, largely due to higher personnel-related expenses [133]. Cash Flow and Financing - As of September 30, 2025, the company had cash and cash equivalents of $16,924,763 and working capital of $11,071,338, but expects expenses to increase substantially, potentially exhausting cash reserves by the second quarter of fiscal year 2026 without additional capital [139]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $15,470,210, compared to $17,070,233 for the same period in 2024 [144]. - The company raised net proceeds of $15,573,966 from the September 2025 Public Offering and $4,592,462 from the June 2025 Private Placement during the nine months ended September 30, 2025 [147]. - The net cash provided by financing activities for the nine months ended September 30, 2025, was $23,753,351, down from $27,635,023 in the same period of 2024 [144]. - Interest income for the nine months ended September 30, 2025 increased by $43,950 to $148,128 compared to $104,178 in 2024, attributed to a higher average cash balance [134]. - The company recognized a total other income of $132,940 for the nine months ended September 30, 2025, compared to a total other expense of $2,237,633 in 2024, reflecting a significant improvement [134]. - The company plans to finance operations through equity offerings, debt financings, or other capital sources, but may face challenges in raising additional funds on favorable terms [140]. Company Classification - The company is classified as an emerging growth company and a smaller reporting company, allowing it to take advantage of scaled disclosures and an extended transition period for compliance with new accounting standards [150][151].

Core Insights - Actuate Therapeutics, Inc. is advancing its investigational drug elraglusib for the treatment of metastatic pancreatic cancer, with a recent public offering raising $17.25 million to support its regulatory path and clinical initiatives [1][5] Regulatory Path and Clinical Trials - The company has amended its IND application with updated clinical data from the Actuate-1801 Part 3B trial, which demonstrated a statistically significant improvement in median overall survival for patients receiving elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) compared to GnP alone [2][5] - The ongoing Phase 2 study has enrolled 286 patients, with 22 patients currently in the elraglusib plus GnP arm showing survival follow-up ranging from 20 to 42 months [3][6] - The trial met its primary endpoint, showing a 37% reduction in the risk of death and a doubling of the 12-month survival rate for the elraglusib combination arm [7] Mechanism of Action and Clinical Collaborations - Elraglusib is a GSK-3β inhibitor that may enhance chemotherapy efficacy and regulate anti-tumor immunity, potentially serving as a backbone therapy in pancreatic cancer treatment [8][10] - The company is collaborating with Incyte and UPMC Hillman Cancer Center to explore elraglusib in combination with modified FOLFIRINOX and retifanlimab for advanced pancreatic cancer [4][8] Financial Position and Future Outlook - The recent financing is expected to provide sufficient capital to support corporate initiatives through the second half of 2026, including anticipated interactions with the FDA and EMA regarding elraglusib's regulatory path [5][8] - The company is optimistic about the survival benefits observed with elraglusib and its potential to be combined with various treatment regimens, addressing the limited options available for pancreatic cancer patients [5][8]

Core Viewpoint - Actuate Therapeutics, Inc. has successfully closed a public offering, raising $17.25 million through the sale of 2,464,286 shares of common stock, with a public offering price of $7.00 per share [1]. Company Overview - Actuate Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for high-impact, difficult-to-treat cancers by inhibiting glycogen synthase kinase-3 beta (GSK-3β) [5]. - The company's lead investigational drug, elraglusib, targets molecular pathways that promote tumor growth and resistance to conventional cancer treatments, potentially enhancing anti-tumor immunity [5]. Financial Details - The net proceeds from the offering are approximately $15.62 million, which will be used for working capital and general corporate purposes [2]. - The offering was managed by Lucid Capital Markets, with Titan Partners Group acting as a financial advisor [2]. Regulatory Information - The common stock was offered under a shelf registration statement on Form S-3, which has been declared effective by the SEC [3]. - A final prospectus supplement related to the offering has been filed with the SEC and is available on their website [3].

Core Viewpoint - Actuate Therapeutics, Inc. has announced a public offering of 2,142,858 shares of common stock at a price of $7.00 per share, aiming to raise approximately $15.0 million for working capital and general corporate purposes [1][3]. Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 321,428 shares at the public offering price [1]. - Lucid Capital Markets is the sole book-running manager, while Titan Partners Group serves as the financial advisor for the offering [2]. Group 2: Financial Information - The gross proceeds from the offering are expected to be around $15.0 million before deducting underwriting discounts and commissions [3]. - The net proceeds will be utilized for working capital and general corporate purposes [3]. Group 3: Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on therapies for high-impact, difficult-to-treat cancers, specifically through the inhibition of glycogen synthase kinase-3 beta (GSK-3β) [6]. - The lead investigational drug, elraglusib, targets molecular pathways that promote tumor growth and resistance to conventional cancer treatments [6].

Core Viewpoint - Actuate Therapeutics, Inc. plans to conduct an underwritten public offering of its common stock to raise funds for working capital and general corporate purposes [1][2]. Company Overview - 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][5]. - The company's lead investigational drug, elraglusib, targets molecular pathways involved in tumor growth and resistance to conventional cancer treatments, potentially enhancing anti-tumor immunity [5]. Offering Details - The company intends to offer shares of its common stock and may grant underwriters a 30-day option to purchase an additional 15% of the shares at the public offering price [1]. - The offering is subject to market conditions, and there is no assurance regarding the completion, size, or terms of the offering [1][6]. - The offering will be made under a shelf registration statement previously filed with the SEC, and a preliminary prospectus supplement has been filed [3].

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].

Core Viewpoint - Actuate Therapeutics has initiated a Phase 1b clinical trial to evaluate the combination of elraglusib, retifanlimab, and modified FOLFIRINOX as a frontline therapy for advanced pancreatic adenocarcinoma, aiming to address unmet medical needs in this challenging cancer type [1][4]. Group 1: Clinical Trial Details - The Phase 1b trial, named RiLEY (NCT06896188), will enroll up to 12 patients initially, with plans for expansion based on interim efficacy results [2]. - The primary objective is to determine the recommended phase 2 dose (RP2D) for the combination regimen, while secondary objectives include evaluating overall response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), overall survival (OS), and safety [2]. Group 2: Mechanism and Previous Results - The combination therapy is expected to provide a synergistic immune-modulatory approach, enhancing anti-tumor responses by targeting multiple immune checkpoints [3]. - Previous studies indicated that elraglusib combined with gemcitabine/nab-paclitaxel resulted in a significant increase in median overall survival, a 37% reduction in the risk of death, and a doubling of the 12-month survival rate in patients with metastatic pancreatic adenocarcinoma [3]. Group 3: Company Strategy and Future Plans - The collaboration with UPMC Hillman Cancer Center and Incyte aims to explore new synergistic opportunities for patients who have not yet received systemic therapy, enhancing both efficacy and durability of response [4]. - Actuate is also conducting a separate Phase 2 trial (NCT05077800) studying elraglusib in combination with FOLFIRINOX and losartan, with initial data showing promising results in patients with extensive liver metastases [4].

Core Insights - Actuate Therapeutics has completed the Phase 1 study of elraglusib in pediatric patients, showing promising results in treating refractory Ewing Sarcoma (EWS) [1][2][3] - The company plans to advance to a Phase 2 trial for elraglusib in children, adolescents, and adults with relapsed/refractory EWS due to the observed complete responses [1][3] Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for high-impact, difficult-to-treat cancers, specifically through the inhibition of glycogen synthase kinase-3 beta (GSK-3β) [1][6] - Elraglusib, the company's lead investigational drug, targets molecular pathways involved in tumor growth and resistance to conventional cancer treatments [6] Clinical Study Details - The Phase 1/2 trial (NCT 04239092), known as Actuate-1902, is an open-label, multicenter study evaluating the safety and efficacy of elraglusib in pediatric patients with relapsed/refractory malignancies, including EWS [2][3] - The study enrolled ten patients with relapsed/refractory EWS, with two patients achieving complete responses and two others showing stable disease [3] Future Plans - The company is planning to initiate a Phase 2 trial in 2026, subject to funding availability, and will engage with regulators to discuss the potential registration path for elraglusib [3][1] - Actuate is collaborating with key opinion leaders and consortiums to ensure the upcoming study design meets patient needs and regulatory expectations [3]