Recent 8-K filings for ACTU

• May 11, 2026, 5:27 PM ET regulatory materiality 0.70 positive item 7.01item 9.01

  Actuate Therapeutics receives FDA IND clearance for oral elraglusib Phase 1/2 study

  FDA cleared IND for Phase 1/2 study of oral elraglusib tablet in advanced solid tumors; initiation planned for 2H 2026.

• January 12, 2026, 6:59 PM ET other material materiality 0.80 positive item 7.01item 9.01

  Actuate Phase 2 pancreatic cancer trial meets OS endpoint; elraglusib+GnP reduces death risk 38%

  Median OS 10.1 mo (elraglusib/GnP) vs 7.2 mo (GnP alone); HR=0.62, p=0.02.

• June 26, 2025, 7:59 PM ET other material materiality 0.70 neutral item 1.01item 3.02item 9.01

  Actuate Therapeutics raises ~$4.7M in private placement of common stock and warrants

  Gross proceeds of approx. $4.7M from sale of 666,497 shares at $7.00/share and warrants to purchase 666,497 shares.

• June 5, 2025, 7:59 PM ET other material materiality 0.90 positive item 7.01item 9.01

  Actuate Therapeutics presents Phase 2 elraglusib data showing overall survival benefit in pancreatic cancer

  Phase 2 (Actuate-1801 Part 3B) data of elraglusib with gemcitabine/nab-paclitaxel showed overall survival benefit in first-line metastatic pancreatic cancer.

• June 2, 2025, 7:59 PM ET other material materiality 0.80 positive item 7.01item 8.01item 9.01

  Actuate reports Phase 2 elraglusib/GnP meets primary OS endpoint in mPDAC

  mOS 10.1 months vs 7.2 months for GnP alone, HR=0.63, log-rank p=0.01, 37% risk reduction.

• May 6, 2025, 7:59 PM ET other material materiality 0.85 positive item 8.01item 9.01

  Actuate elraglusib Phase 2 meets primary endpoint with statistically significant OS improvement in mPDAC

  Elraglusib plus GnP showed statistically significant overall survival improvement vs GnP alone in first-line mPDAC.

• March 28, 2025, 7:59 PM ET other material materiality 0.70 neutral item 1.01item 3.02item 9.01

  Actuate Therapeutics enters $50M equity line with B. Riley, can sell shares at 3% VWAP discount

  Company may sell up to $50M of common stock to B. Riley Principal Capital II over 36 months at a 3% discount to VWAP.

• December 17, 2024, 6:59 PM ET other material materiality 0.85 positive item 7.01item 9.01

  Actuate Therapeutics: elraglusib Phase 2 meets primary endpoint; 1-year survival 43.6% vs 22.5% in mPDAC

  1-year survival rate 43.6% in elraglusib+GnP arm vs 22.5% in GnP alone (p=0.002); median OS 9.3 vs 7.2 months (HR=0.63, p=0.016).

• November 12, 2024, 6:59 PM ET regulatory materiality 0.70 positive item 7.01item 9.01

  Actuate Therapeutics receives FDA Rare Pediatric Disease Designation for elraglusib in Ewing sarcoma

  FDA grants Rare Pediatric Disease Designation for elraglusib, a GSK-3β inhibitor, to treat Ewing sarcoma.

• August 19, 2024, 7:59 PM ET regulatory materiality 0.70 negative item 4.01item 9.01

  Actuate Therapeutics replaces auditor after KMJ joins Crowe; prior reports cite going concern and material weakness

  KMJ Corbin & Company LLP resigned as auditor on Aug 19, 2024; Crowe LLP appointed same day.

• August 14, 2024, 7:59 PM ET other material materiality 0.85 positive item 5.02item 5.03item 8.01item 9.01 ◈ executive_change ×4

  Actuate Therapeutics completes IPO of 2.8M shares at $8.00, net proceeds $19.2M

  IPO closed Aug 14, 2024: 2,800,000 shares at $8.00/share, net proceeds $19.2M.

Executive changes

Materiality & sentiment trend

Max materiality 0.90 · Median 0.70 · Most common event other_material

9 positive 1 negative 8 neutral

source · ACTU on sec.gov