Actuate Therapeutics (ACTU) PT Lowered to $8 at B.Riley

B.Riley analyst Mayank Mamtani lowered the price target on Actuate Therapeutics (NASDAQ: ACTU) to $8.00 (from $20.00) while maintaining a Buy rating.

The analyst comments "Today's (4/14) Nature Medicine publication of the Actuate-1801 Part 3B randomized Ph2 data, the first peer-reviewed RCT demonstrating statistically significant survival benefit in frontline mPDAC with GSK-3β inhibitor elraglusib (elra). The mITT population (n=233 evaluable) showed a 38% reduction in risk of death (HR 0.62; p=0.01), a doubling of 1-year OS (44% vs. 22%), with new PK/exposure data identifying a therapeutic C-avg threshold of >210 ng/mL, above which the HR improves to ~0.48; ~40% of patients on the once-weekly IV regimen fell below that target suggesting encouraging prospect of efficacy floor likely raised with oral daily tablet regimen. PK modeling supports ~one tablet/day to clear this C-avg threshold. The oral program prioritizes refractory melanoma as a lead monotherapy cohort alongside CRC and NSCLC combination arms (~80–100 total patients), targeting RP2D dose selection by mid-2027 and likely progression to accelerated approval trials thereafter. This likely involves foregoing the previously planned 3+ year IV elra/GnP confirmatory Ph3 with strategic intent to position the oral program as the immunomodulator combination of choice within the rapidly evolving RAS inhibitor landscape, e.g., RASolute302 Ph3 daraxonrasib showing unprecedented mOS doubling to 13+ months, likely reshaping the PDAC treatment paradigm. We also note an arguably more compelling read from the at-least-one-cycle sensitivity analysis (n=174), where mOS improved to 12.5 vs. 8.5 months (HR 0.57; p=0.018), validating that the mITT headline conservatively reflects a sicker-than-typical real-world cohort. In rare pediatric heavily refractory tumor settings, CRUK's fully funded Beacon-2 neuroblastoma inclusion and the Ewing sarcoma pre-IND filings process are progressing to likely yield non-dilutive financing pathways (1/7 note). NT catalysts include an EMA conditional approval decision expected by the end of April and partner-ready preclinical data for the RAS/KRAS combination from Northwestern/Mayo, expected in the coming months. That said, revenue push-out against the backdrop of financing overhang lowers our PT from $20 to $8."

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