Oslo, Norway, 3 March 2026. EXACT Therapeutics (the "Company", Euronext Growth
ticker: EXTX), a clinical-stage precision medicine company, today announced that
the first patient has been dosed in Europe in its Phase 2 ENACT trial. The
recruitment takes place at three hospital sites in Europe, in addition to seven
sites in the U.S. All sites are now active.
The trial is a multi-centre, open-label Phase 2 clinical trial testing the
safety and efficacy of PS101 in combination with standard of care (modified
FOLFIRINOX chemotherapy) in first line patients with borderline resectable or
unresectable locally advanced pancreatic cancer. On 27 January, the Company
published a positive safety read-out and early, encouraging tumour shrinkage,
and significant decrease in tumour biomarker CA 19-9 (>85% decrease, unaudited
data) from the first safety cohort (40 µl/kg of PS101).
"We are delighted to see the Phase 2 ENACT trial progress to treating its first
patient in Europe at Hammersmith Hospital, Imperial College London. This
represents an important step in a study addressing a significant unmet medical
need in pancreatic cancer, and we look forward to contributing to the generation
of robust clinical data." said the Coordinating Investigator of the ENACT trial,
Professor Harpreet Wasan, leading the pancreatic cancer team at Hammersmith.
"The first pancreatic cancer patient treated with PS101 in Europe is an
important execution milestone for the ENACT trial. With full site activation
across the U.S. and Europe, enrolment and execution are progressing as planned.
We remain focused on disciplined trial execution as we advance the trial toward
interim read-out expected mid-2026." said Per Walday, Chief Executive Officer of
EXACT Therapeutics.
The Phase 2 trial will enrol approximately 28 patients in the U.S. and Europe
and has the ClinicalTrials.gov Identifier: NCT06850623.
About EXACT Therapeutics:
EXACT Therapeutics is a clinical-stage precision medicine company utilizing the
power of ultrasound to activate the proprietary drug PS101 and unlock targeted
oncology therapies. PS101 has a unique mode of action and may be combined with a
wide range of therapeutic agents within oncology and across a multitude of other
indications, including brain diseases. EXACT Therapeutics' shares are traded on
Euronext Growth Oslo (EXTX). Further information may be found here:
www.exact-tx.com
For further information, please contact:
Per Walday
CEO EXACT Therapeutics
Email: per.walday@exact-tx.com
Forward looking statements:
This announcement and any materials distributed in connection with this
announcement may contain certain forward-looking statements. By their nature,
forward-looking statements involve risk and uncertainty because they reflect the
Company's current expectations and assumptions as to future events and
circumstances that may not prove accurate. A number of material factors could
cause actual results and developments to differ materially from those expressed
or implied by this forward-looking statement.