Core Insights - Actuate Therapeutics plans to initiate a Phase 1/2 clinical program for elraglusib, an oral tablet formulation targeting advanced cancers, in the second half of 2026 [1][2] Group 1: Clinical Trial Details - The Phase 1 portion aims to determine the maximum tolerated dose (MTD) and assess dose-limiting toxicities (DLTs) of elraglusib tablets, while also investigating pharmacokinetics (PK) and preliminary anti-tumor activity [2] - The Phase 2 trial will focus on patients with refractory metastatic melanoma and other indications, building on previous encouraging results from a Phase 1 study where 5 out of 10 patients achieved disease control lasting 12 weeks or longer [2] - In the earlier Phase 1 study involving 67 patients, the median overall survival was reported at 9.9 months, with one patient achieving a complete response lasting over 6 years [2] Group 2: Drug Mechanism and Target Indications - Elraglusib targets glycogen synthase kinase-3 beta (GSK-3β), which is implicated in cancer progression, particularly in melanoma [3] - The drug may provide synergistic potential with existing therapies, such as BRAF and MEK inhibitors, and immune checkpoint inhibitors (ICIs) [3] - The company plans to include additional targeted histologies in the Phase 1/2 study, particularly select hematologic malignancies where GSK-3β inhibition has shown activity [4] Group 3: Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for difficult-to-treat cancers [5] - The lead investigational drug, elraglusib, is a novel GSK-3β inhibitor that targets molecular pathways involved in tumor growth and resistance to conventional therapies [5][6]

Two Complete Metabolic Responses (CMRs) observed in patients with relapsed/refractory metastatic Ewing sarcoma and one Complete Response (CR) observed in a patient with relapsed/refractory metastatic neuroblastomaClinical responses and disease control observed in 15 of 40 patients with difficult-to-treat refractory pediatric cancers, including 10 of 19 patients treated with elraglusib plus cyclophosphamide/topotecanData support advancing clinical development of elraglusib in Ewing sarcoma and potentially ne ...

Actuate Therapeutics, Inc. (ACTU) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years ...

Core Insights - Actuate Therapeutics, Inc. announced that data from its Phase 2 study of elraglusib in metastatic pancreatic cancer will be presented at the 2026 ASCO GI Cancers Symposium [1] - The study evaluates elraglusib in combination with gemcitabine/nab-paclitaxel, a standard chemotherapy regimen for this type of cancer [1] Presentation Details - Oral Presentation: Results from the randomized Phase 2 study (1801 Part 3B) of elraglusib plus gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in previously untreated metastatic pancreatic ductal adenocarcinoma [2] - Date/Time: January 9, 2026, 4:15 PM-5:00 PM (PST) [2] - First Author: Devalingam Mahalingam, MD, PhD, Gastrointestinal Oncologist at Northwestern University [2] Poster Presentation - Title: Mutational analysis and identification of potential biomarkers in patients with metastatic pancreatic cancer treated with elraglusib and gemcitabine/nab-paclitaxel [3] - Date/Time: January 9, 2026, 11:30 AM-1:00 PM; 5:00 PM-6:00 PM (PST) [4] - First Author: Andrey Ugolkov, MD, PhD, Senior Director, Clinical Science at Actuate Therapeutics [4] Company Overview - Actuate Therapeutics is focused on developing therapies for high-impact, difficult-to-treat cancers [4] - The lead investigational drug, elraglusib, is a novel GSK-3β inhibitor targeting pathways involved in tumor growth and resistance to conventional therapies [4]

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].