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