Actuate Therapeutics Initiates Elraglusib Clinical Trial
Actuate Therapeutics announced plans to initiate a Phase 1/2 clinical program evaluating the oral tablet dosage form of elraglusib in patients with advanced cancer. The phase 1 portion of the planned Phase 1/2 program aims to determine the maximum tolerated dose or maximum administered dose and dose-limiting toxicities of elraglusib tablets administered once daily and will investigate the pharmacokinetics of elraglusib tablets as well as the preliminary anti-tumor activity of elraglusib when administered as tablets. The goal of the phase 1 portion of the program will be to establish the recommended dose of elraglusib tablets for expansion in subsequent development
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Positive Study Results: Actuate Therapeutics reported favorable outcomes from a Phase II study of elraglusib combined with carboplatin or cisplatin for advanced metastatic salivary gland cancers, showing a median overall survival of 18.6 months.
Patient Demographics and Survival Rates: The study included 47% adenoid cystic carcinoma (ACC) and 53% non-ACC patients, with non-ACC patients experiencing a median overall survival of 27.8 months.
Progression-Free Survival: The median progression-free survival was 6.4 months, with only 27% of patients remaining progression-free at one year, contrasting with historical estimates for ACC and non-ACC.
Market Reaction: Following the announcement, Actuate shares increased by over 4% in pre-market trading, closing at $7.52, reflecting a 1.35% rise from the previous day.

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Public Offering Announcement: Actuate Therapeutics, Inc. has priced an underwritten public offering of 2,142,858 shares of common stock at $7.00 per share, aiming to raise approximately $15 million for working capital and corporate purposes.
Use of Proceeds: The company plans to utilize the net proceeds from the offering for general corporate needs, with the offering expected to close on September 11, 2025, pending customary closing conditions.
Company Focus: Actuate Therapeutics is a clinical-stage biopharmaceutical company developing therapies for challenging cancers, with its lead drug, elraglusib, targeting pathways that promote tumor growth and resistance to conventional treatments.
Forward-Looking Statements: The press release includes forward-looking statements regarding the offering's timing and completion, emphasizing the inherent risks and uncertainties that could affect actual results.

Analyst Ratings Updates: Top Wall Street analysts have revised their outlooks on several companies, with a focus on upgrades and new coverage initiations.
Actuate Therapeutics Coverage: B. Riley Securities analyst Mayank Mamtani initiated coverage on Actuate Therapeutics (ACTU) with a Buy rating and a price target of $20, while the stock closed at $7.98.
Gyre Therapeutics Coverage: HC Wainwright & Co. analyst Matthew Keller also initiated coverage on Gyre Therapeutics (GYRE) with a Buy rating and a price target of $18, closing at $8.18.
CareDx Coverage: William Blair analyst Andrew Brackmann started coverage on CareDx (CDNA) with a Market Perform rating, with shares closing at $12.75.

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Clinical Trial Announcement: Actuate Therapeutics has initiated a Phase 1b clinical trial at UPMC Hillman Cancer Center to evaluate the combination of elraglusib, retifanlimab, and modified FOLFIRINOX as a frontline therapy for advanced pancreatic adenocarcinoma, aiming to determine the recommended phase 2 dose and assess efficacy and safety.
Potential Benefits of Elraglusib: Previous studies have shown that elraglusib can enhance immune responses in cancer treatment, demonstrating significant improvements in overall survival rates when combined with other therapies, suggesting its potential as a novel approach in treating difficult cancers like pancreatic adenocarcinoma.





