Actuate Therapeutics identifies biomarkers for pancreatic cancer drug

CHICAGO/FORT WORTH - Actuate Therapeutics, Inc. (NASDAQ:ACTU), a clinical-stage biotech company currently trading at $7.49 per share, has identified seven biomarkers that may help predict which metastatic pancreatic cancer patients could benefit from its investigational drug elraglusib, according to data presented at the American Society of Clinical Oncology annual meeting. According to InvestingPro analysis, the stock appears undervalued despite recent market challenges, with analyst price targets ranging from $20 to $35.

The biomarker analysis from the company’s Phase 2 trial examined plasma samples from patients with first-line metastatic pancreatic adenocarcinoma who received elraglusib in combination with gemcitabine/nab-paclitaxel.

Researchers identified CXCL2 as a consistently reliable biomarker for survival, with elevated levels associated with improved overall survival in patients treated with elraglusib. This finding is notable as high CXCL2 levels were unfavorable in the control arm not receiving elraglusib.

The study also found that elevated levels of TRAIL and lower levels of CCL3, IL-1α, IL-18, TGF-β, and TRAIL R3 were linked to better survival outcomes in the elraglusib treatment group.

"These results represent an important advance in our biomarker strategy," said Daniel Schmitt, President and CEO of Actuate. "They support the ability to use simple, non-invasive blood-based markers to potentially identify patients more likely to benefit from elraglusib." While the clinical progress is promising, InvestingPro data reveals some financial challenges, including weak gross profit margins and short-term liquidity concerns. InvestingPro subscribers can access 6 additional key insights about ACTU’s financial health.

The company plans to test these biomarkers prospectively in future trials and will focus on optimizing combinations for patient stratification.

Elraglusib is a GSK-3β inhibitor that targets molecular pathways involved in tumor growth and resistance to conventional cancer drugs. The company is developing the drug for difficult-to-treat cancers.

The findings were based on analysis of 40 cytokines, chemokines, soluble cell receptors, and growth factors from plasma samples obtained prior to treatment, according to the company’s press release statement. Looking ahead, analysts maintain a strong buy consensus on ACTU, though InvestingPro data indicates the company is not expected to achieve profitability this year, with a projected EPS of -$1.40 for 2025.

In other recent news, Actuate Therapeutics announced that its drug elraglusib, in combination with chemotherapy, has met primary endpoints in a Phase 2 trial for metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial demonstrated a statistically significant improvement in overall survival for patients receiving elraglusib alongside gemcitabine and nab-paclitaxel compared to the chemotherapy regimen alone. This development marks a significant advancement in the treatment of mPDAC, a cancer type with limited progress over the past decade. Actuate plans to engage with U.S. and EU regulators to discuss advancing the drug toward a New Drug Application. Additionally, Craig-Hallum has initiated coverage on Actuate Therapeutics with a Buy rating and a price target of $21.00, citing optimism about elraglusib’s potential to improve survival outcomes in mPDAC. The firm’s analysts are encouraged by interim data from the Phase II study and expect the upcoming topline readout to enhance the company’s value. Actuate’s financial position, with $8.6 million in cash at the end of the previous year, could benefit from these positive clinical developments.

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