EXACT Therapeutics (EXTX) Company presentation summary

Oncology development and clinical progress

• PS101, a proprietary ultrasound-activated prodrug, demonstrated a 4x increase in tumor shrinkage versus standard of care in Phase 1 for liver metastases and showed excellent safety.

• Ongoing Phase 2 ENACT trial in first-line locally advanced pancreatic cancer patients in the US and UK reported positive initial safety and early encouraging treatment responses.

• Early ENACT data showed ≥85% reduction in CA 19-9 biomarker and up to 46% tumor shrinkage in initial patients, indicating strong clinical benefit potential.

• PS101 enables targeted, organ-specific drug delivery through a non-invasive, ultrasound-activated process, enhancing chemotherapy effects.

• The addressable patient population for the lead indication is approximately 30,000 annually in the USA and EU5.

Strategic focus and pipeline expansion

• Core focus is on winning in locally advanced pancreatic cancer, with the ENACT Phase 2 trial as the top priority.

• Preclinical pipeline includes gene therapy (nonviral delivery), CNS cancers, blood-brain barrier applications, and immuno-oncology combinations.

• Preclinical studies show PS101 can open the blood-brain barrier and enhance delivery of various drug formulations.

• Immuno-oncology applications and glioblastoma models are being explored, with promising preclinical results.

• Broad IP coverage supports expansion into multiple therapeutic areas.

Financials, milestones, and outlook

• Raised $13M in December 2024, with up to $6M more from warrant exercises expected in February 2026; 75% of this amount is already secured.

• Use of proceeds includes securing the ENACT trial through key data points, expanding IP, and supporting non-clinical research.

• Major milestones achieved include final Phase 1 results, regulatory approvals, and initial dosing in Phase 2.

• Near-term news flow in 2026 includes publication of Phase 1 results, multiple ENACT trial readouts, and preclinical updates.

• Partnership with a leading medical equipment company strengthens device and supply chain support.