EXACT Therapeutics : Interim Report 2023

INTERIM REPORT

First half year 2023

EXACT Therapeutics

Unique platform technology

Ultrasound guided targeted therapeutic enhancement using proprietary micro-bubbles for effective, drug agnostic delivery

Encouraging initial clinical data

Ongoing multinational clinical program, with established infrastructure for expansion

Strong scientific rationale

Extensive preclinical safety documentation and preclinical efficacy data with SoC cancer therapies

Attractive competitive position

First mover (clinical stage) with ultrasound market leader collaboration and commercial scale GMP manufacturing

Robust Development strategy

Targeting high value markets with significant unmet medical needs

Straight commercial adoption

Customised ultrasound probe compatible with a vast installed base globally

Competent experienced leadership

Management and board with broad and relevant experience and network

CONTENTS

H1 2023 Highlights	3
Operational Review	5
Financial Review	6
Key Figures	7
Consolidated financial Statements	8
Notes to the financial statements	12-18

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HIGHLIGHTS H1 2023

Reflecting on the first half of 2023, we at EXACT Therapeutics ("EXACT-Tx" or "Company") are pleased to report a period of active and positive progress building momentum. Following the organizational build-up in 2022, we now have a strong team in place allowing us to focus on the development of our Acoustic Cluster Therapy (ACT®) platform. The highlights of the year so far include:

Reopening and progressing the clinical program, with encouraging initial results

The ACTIVATE phase I clinical trial was reopened in February, following MHRA's approval of both the medical device documentation and the amended protocol. The dose-escalation part of this trial was successfully completed in August, demonstrating both safety and encouraging anti-tumour effect in this hard-to-treat patient population with liver metastases of colorectal cancer origin. The next phase (dose- expansion) of the ACTIVATE trial has commenced, with the aim to expand the body of clinical data and determine the recommended dose for further clinical development.

Advancing toward Phase 2 in critical unmet medical areas

A new Phase 2 trial in pancreatic cancer is being planned following extensive consultations with international clinical expert advisors. This follows on from the excellent pre-clinical data which has been published by a leading clinical research group in the US. The trial will span both Europe and the US, and the Company will engage in discussions with the US Food and Drug Administration (FDA) with the goal of initiating an Investigational New Drug (IND) application in the first half of 2024. In parallel, we are actively pursuing preclinical activities, advancing medical device development,

and fostering collaborations to pave the way for the commencement of additional clinical trials addressing areas with high unmet medical need.

Pursuing collaborative efforts to deliver drugs across the blood-brain-barrier (BBB)

Delivery across the BBB has remained a pivotal challenge in advancing novel drug therapies for brain- related disorders. Following the excellent pre-clinical results showing that ACT can enable delivery across the BBB, we are intensifying our focus on this critical area. In September, EXACT-Tx announced a strategic partnership with Cordance Medical.This partnership will combine the ACT technology with Cordance's NeuroAccess™ platform, with the aim of delivering more effective drug therapy across the blood-brain- barrier (BBB). By integrating the two technologies, the companies aim to provide cutting-edge, targeted treatment options in upcoming clinical trials.

Further strengthening the research and the patents underpinning the ACT platform

EXACT-Tx is diligently expanding the knowledge and intellectual property base of the ACT platform through extensive collaborations with international academic partners. Notable milestones include the publication in January of a scientific article titled "Real-TimeIntravital Imaging of Acoustic Cluster Therapy-InducedVascular Effects in the Murine Brain" in Ultrasound in Medicine and Biology. Additionally, in April, our collaborators at the Norwegian University of Science and Technology (NTNU) presented a poster "Real-timeintravital multiphoton microscopy of tumours during Acoustic Cluster Therapy" at the International Society for Therapeutic Ultrasound (ISTU) annual symposium in Lyon. In June,we initiated a new project in collaboration with our longstanding academic research partners at the Institute of Cancer Research (ICR) in London, aimed at advancing our

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understanding of the biological mechanisms governing ACT's functions. This deeper comprehension holds the potential for optimizing ACT's impact on tumours. Moreover, in May, we were delighted to announce the issuance of a patent entitled "Treatment of infections" by the United Kingdom Intellectual Property Office. This patent encompasses EXACT-Tx's unique microbubble/microdroplet formulation (PS101) and its co-administration with various pharmaceutical agents for drug targeting in infection treatment.

Communicating the unique ACT concept in the emerging field of therapeutic ultrasound

The international market interest in therapeutic ultrasound continues to grow and in March EXACT-Tx hosted a Science and Technology Event at Oslo Science Park to showcase our positive results and unique position in this emerging field. The presentations included an update from the ACTIVATE study by the Principal Investigator Prof. Dr Udai Banerji and EXACT-Tx's CMO Dr Amir Snapir, as well as presentations from chairman of the Board, Anders Wold, CEO Per Walday and Board member Sir William Castell. In July, the Wall Street Journal published an article titled "New Ultrasound Therapy Could Help Treat Alzheimer's, Cancer - Sound waves combined with tiny bubbles in the bloodstream can push drugs into the brain and tough-to-reachtumors". The article highlighted the potential of therapeutic ultrasound technologies and EXACT-Tx was featured as one of three exciting companies within the field.

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OPERATIONAL REVIEW

During the first half of 2023,EXACT-Tx concentrated its operational efforts on resuming and advancing the Phase 1 ACTIVATE clinical study. Following regulatory approval to recommence the study in February, the Company initiated recruitment for the dose escalation phase of the ACTIVATE study. By August, the dose escalation phase had successfully concluded, with encouraging clinical results.

EXACT-Tx has secured access to large-scale Good Manufacturing Practice (GMP) production of PS101, effectively overcoming the customary manufacturing hurdles that typically accompany the initial stages of pharmaceutical development. An important milestone was achieved in the first half of 2023, as we successfully completed batch production of PS101 at the GE Healthcare facility in Oslo.We now possess an ample supply of PS101, capable of underpinning all our preclinical and clinical endeavours over the next 3-4 years.

In December 2022, EXACT-Tx announced the grant of NOK 16 million for the pre-clinical studies of ACT and immuno-oncology. During the first six months of 2023, we have worked together with our research collaboration partners (Institute of the Cancer Research (ICR) in London, UK, the Translational Genomics Research Institute (TGen) in Phoenix, USA, and the Norwegian University of Science and Technology (NTNU) in Trondheim, Norway) to finalise agreements and determine the design of these studies.

Outlook

The Board and management of EXACT-Tx believe that, with ACT, the Company is well placed to benefit from the growing market interest and investments in the therapeutic capabilities of ultrasound technology. The interest in focused ultrasound technology as a method of targeted drug delivery continues to augment, and for EXACT-Tx it is encouraging to see the research and development activities going on across this space.

For the remainder of 2023 and into the first half of 2024, our business strategy aims to prioritise the following objectives:

• Expand and progress the ACTIVATE study to completion of the dose expansion part
• Prepare and submit an Investigational New Drug (IND) application in the US for a Phase II clinical study of ACT in pancreatic cancer
• Progress the collaborative immuno-oncology project with our international academic expert groups to elucidate the potential of ACT in immunotherapy
• Strengthen our R&D platform and preclinical programs through in-house research and partnerships with existing and new collaborators
• Ensure resource capability to drive optimal progress in clinical development and preclinical expansion of the ACT platform

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