OSLO, 31 October 2023: EXACT THERAPEUTICS AS ("EXACT-Tx", Euronext Growth:
EXTX), a clinical stage precision medicine company utilising Acoustic Cluster
Therapy (ACT®) across multiple therapeutic areas, today announces that the
Norwegian Medicines Agency (NOMA) and the Ethics Committee have awarded all
necessary approvals to start recruitment of patients into the dose expansion
part of the ACTIVATE study in Norway. This follows the recently announced
approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA). 

The approvals means that EXACT-Tx may initiate recruitment of patients at Oslo
University Hospital for the dose expansion part of the ACTIVATE study. This part
of the ACTIVATE study is designed to determine the dose level for further
development and expand the safety and efficacy data of ACT in patients with
metastatic colorectal cancer. 12 to 20 patients are planned to be enrolled into
the dose expansion part of the ACTIVATE study.  

Per Walday, CEO, comments: "We are very pleased being able to start recruiting
patients at the Oslo University Hospital in Norway, in addition to the already
included sites in the UK. A strong relationship with the clinical expertise in
Norway is important to us and we look forward to start recruiting Norwegian
patients into the dose expansion in ACTIVATE." 
 

For more information, please contact:  

Per Walday  
CEO EXACT Therapeutics  
Email: per.walday@exact-tx.com  


About EXACT-Tx:  

EXACT-Tx is a clinical-stage Norwegian precision medicine company developing a
technology platform for targeted therapeutic enhancement - Acoustic Cluster
Therapy (ACT®). ACT follows a unique approach to ultrasound-mediated, targeted
drug enhancement - with the potential to significantly amplify the clinical
utility of a wide range of therapeutic agents across a multitude of indications
including within oncology (chemotherapy, immunotherapy) and brain diseases.
www.exact-tx.com 

About ACT®  

o ACT® is a proprietary formulation consisting of microbubbles and microdroplets
that are activated through the application of ultrasound with the consequent
increase in targeted delivery of a co-administered therapeutic agent.  

o ACT® is supported by a strong and broad preclinical package demonstrating
therapeutic enhancement in multiple oncology models (pancreatic, breast, colon,
prostate) as well as blood-brain barrier penetration.  

o Initial focus of the Company is oncology, however the ACT® platform has
potential across therapeutic areas (CNS, immunotherapy) and product classes.  

 

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.