EXACT Therapeutics: Positive initial safety read-out from the Phase 2 ENACT trial in pancreatic cancer, triggering option to exercise warrants

27 Jan 2026 08:00 CET

Trial Monitoring Committee has issued a positive conclusion for the pre-planned
safety read-out and the trial proceeds as planned

Early, encouraging tumour shrinkage, and significant decrease in tumour
biomarker CA 19-9 (>85% decrease, unaudited data)

Interim efficacy read-out is expected mid-2026

This safety read-out triggers the potential exercise of the warrants issued as
part of the private placement completed on 3 December 2024.

Oslo, Norway, 27 January 2026. Reference is made to the private placement of
EXACT Therapeutics AS ("EXACT-Tx" or the "Company", Euronext Growth ticker:
EXTX), a clinical-stage precision medicine company, completed on 3 December 2024
(the "Private Placement"), in which the participants received a right to
subscribe for additional shares following the announcement of the initial safety
read-out from the phase 2 ENACT trial in pancreatic cancer. The Company is
pleased to announce that the Trial Monitoring Committee ("TMC") for the Phase 2
ENACT trial in first line locally advanced pancreatic cancer (NCT06850623) has
unanimously issued a positive conclusion for the safety read-out following the
per-protocol review of the first safety cohort enrolled in the trial and
recommended to proceed with the trial as planned.

The safety read-out triggers the potential exercise of up to 50,622,348 warrants
held by the shareholders which participated in the Private Placement (the
"Warrants"). The strike price per Warrant is 1.23 NOK, corresponding to a 20%
discount to the 3-month volume-weighted average price prior to this
announcement. In accordance with the terms of the Private Placement and the
Warrants, the Company’s largest shareholder, GE Medical Holding AB will give
notice to the Company of whether it wishes to exercise its Warrants within 15
business days from today. Following the notice from GE Medical Holding AB, other
warrant holders may exercise their Warrants within an additional 15 business
days. Subject to the total number of Warrants exercised, the Company may call
for an extraordinary general meeting of the Company, to ensure that the
sufficient number of new shares can be issued. Updates on the Warrant exercise
will be provided in due course.

The TMC has reviewed the safety data from the initial safety cohort with four
subjects with locally advanced pancreatic cancer treated with the company’s
proprietary PS101 product candidate, at a dose of 40 µl/kg body weight in
combination with modified FOLFIRINOX. The TMC concluded that based on the safety
cohort data, PS101 was well tolerated and recommends proceeding with the trial
as planned. This aligns with the excellent safety profile observed in the Phase
1 trial involving patients with liver metastases treated with PS101
(NCT04021277). The response to treatment registered so far is encouraging, with
significant decrease in tumour biomarker CA 19-9 (>85% decrease, unaudited data)
and tumour shrinkage on imaging at the trial hospitals.

Given this positive safety profile, the TMC recommends evaluating a higher dose
level of 60µl/kg, which is permitted under the regulatory-approved protocol and
could potentially benefit the treatment of pancreatic cancer patients. EXACT has
decided to follow the TMC’s recommendation and three subjects will now be
evaluated in a safety cohort by the TMC before opening full enrolment at the
selected dose level.

The vast majority of planned hospital sites are now open for enrolment, and the
interim efficacy read-out is expected mid-2026, in accordance with the timeline
previously communicated.

Per Walday, CEO of EXACT-Tx comments:
"We are delighted to have reached this important milestone in our Phase 2 trial
and are encouraged by the positive initial safety and tumour response data and
the Trial Monitoring Committee’s recommendation. Pancreatic cancer remains a
disease with significant unmet medical need, and we remain fully focused on the
successful execution of this trial in the U.S. and U.K."


Information in this announcement is considered inside information pursuant to EU
Market Abuse Regulation (MAR) and subject to the disclosure requirements
pursuant to MAR Article 17 and Section 5-12 of the Norwegian Securities Trading
Act. This stock exchange announcement was published by John M. Edminson, CFO, on
07:59 (CET) 27 January 2026.

About EXACT Therapeutics:
EXACT Therapeutics is a clinical-stage precision medicine company utilizing the
power of ultrasound to activate the proprietary drug PS101 and enhance the
clinical benefit of 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.

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