VS-7375 Shows 50% ORR in 2L PDAC, Phase 3 Planned for 2026

Updates

1. Oct 14, 10:17 AM ET · Benzinga — VS-7375 achieved 75% ORR in first-line lung cancer cohort (n=8) and 86% disease control rate in 2L+ PDAC.

   • Efficacy in PDAC — VS-7375 showed 36% ORR in third- and fourth-line PDAC, six-month progression-free survival of 67% and six-month overall survival of 80% in 2L+ PDAC. All 12 evaluable PDAC patients with detectable KRAS G12D ctDNA achieved at least 50% reduction, and seven achieved complete clearance of detectable KRAS G12D circulating tumor DNA.
   • Dose Response — 900 mg dose produced deeper tumor reductions and higher response rates than 600 mg dose.
   • Phase 3 Design — Phase 3 will compare two VS-7375 combination regimens against standard-of-care chemotherapy in first-line mPDAC: VS-7375 with anti-EGFR therapy and VS-7375 with gemcitabine/nab-paclitaxel. Company aligned with FDA on Phase 3 trial design.
   • Safety — VS-7375 maintained manageable safety profile across monotherapy and combination regimens at 600 mg and 900 mg.
   • Offering Terms — Offering priced 30.937 million shares at $8 each and included pre-funded warrants for 312,503 shares at $7.9999 apiece. Gross proceeds of $250 million will support clinical development, working capital, and general corporate purposes.
   • Colorectal Cancer — VS-7375 at 900 mg combined with an anti-EGFR therapy produced a 33% ORR among six patients in third-line and later metastatic colorectal cancer, including one confirmed and one unconfirmed response.
   All 14 details

   • VS-7375 showed 36% ORR in third- and fourth-line PDAC settings.
   • VS-7375 achieved six-month progression-free survival of 67% in 2L+ PDAC.
   • VS-7375 achieved six-month overall survival of 80% in 2L+ PDAC.
   • 900 mg dose produced deeper tumor reductions and higher response rates than 600 mg dose.
   • All 12 evaluable PDAC patients with detectable KRAS G12D ctDNA achieved at least 50% reduction.
   • Seven PDAC patients achieved complete clearance of detectable KRAS G12D circulating tumor DNA.
   • Phase 3 will compare two VS-7375 combination regimens against standard-of-care chemotherapy in first-line mPDAC.
   • Phase 3 experimental arms: VS-7375 with anti-EGFR therapy and VS-7375 with gemcitabine/nab-paclitaxel.
   • VS-7375 maintained manageable safety profile across monotherapy and combination regimens at 600 mg and 900 mg.
   • Offering priced 30.937 million shares at $8 each.
   • Offering included pre-funded warrants for 312,503 shares at $7.9999 apiece.
   • Gross proceeds of $250 million will support clinical development, working capital, and general corporate purposes.
   • Company aligned with FDA on Phase 3 trial design for first-line metastatic pancreatic cancer.
   • VS-7375 at 900 mg combined with an anti-EGFR therapy produced a 33% ORR among six patients in third-line and later metastatic colorectal cancer, including one confirmed and one unconfirmed response.

2. Oct 14, 6:08 AM ET · SEC 8-K — The 8-K adds preliminary Q3 net product revenue of $23.9M-$24.1M and cash of $172.8M, and discloses CEO transition to Michael Bailey effective Jan 1, 2027.