Environmental, Social and Governance Report

EXACT Therapeutics is founded on the vision of enhancing the therapeutic efficacy of medicines through ultrasound-mediated drug delivery.

We aim to contribute to the medical development that will improve and save lives and thereby creating value for society, patients, and shareholders. For us, sustainability is the foundation of our activities and our long-term success is directly link to this.

The potential to co-administer ACT® with standard of care (and often generic) medicines to improve outcomes for patients contributes to the sustainability of existing therapeutics.

As we develop our business, we are committed to doing so in line with international best practices on Environmental, Social, and Governance (ESG), in particular Agenda 2030 and the Sustainable Development Goals (SDG), as formulated by the United Nations and launched in 2015.

 Our vision and UN’s Sustainable Development Goals (SDG)

We work hard every day to develop innovative methods for enhancing the therapeutic efficacy of medicines, and a key focus goal for EXACT-Tx is consequently to innovate (SDG 9) to contribute to improved effect from medicines, and from that increased health for patients (SDG 3). While this is our end goal, we are working systematically at contributing to this goal by our efforts to enable goals 8, 9, 12, and 17. We believe that our positive contribution to Agenda 2030 and the SDGs will be largest if we manage to be a role model for responsible production (SDG 12) – an actor working in partnerships with others (SDG 12 and SDG 17) in order to promote innovation (SDG 9), economic growth and decent work (SDG 8).

EXACT-Tx have started the process of strengthening our sustainability work. The process has started with identifying key ESG impacts that are material to us and our stakeholders. Our key stakeholders include our employees, investors, regulators, suppliers, and other business partners, such as research organizations and academic institutions. The keys ESG impacts represents risks, but also opportunities.

­Initial risk (in red) and opportunities (in green) analysis:

Environmental:

Overall:

The daily operations of EXACT-Tx have low environmental impact. The Company has an asset light organization with no in­house production or external sales activities. Travels are kept at a minimum, and the office facilities are mostly paperless. We have no company cars. Our in-house, state of the art technical laboratory have little or no environmental impact.

Responsible supply chain (2)

We acknowledge that our subcontractors – and their emissions – are part of our supply chain and, hence, indirect emissions. We acknowledge to be part of a major industry with a significant footprint in total. Our efforts to reduce the footprint is done in collaboration with our main suppliers.

Sonazoid™ is a key component in ACT. The microbubbles in Sonazoid™ encapsulate small amounts of a greenhouse gas. The microbubbles are manufactured at a CMO, GE Healthcare AS. The current manufacturing is regulated and focuses on capturing gas during manufacturing. Emissions are governed by a permit from the local Environmental Agency and there are initiatives in place to reduce emissions. GE Healthcare AS is in collaboration with the gas supplier to evaluate use of captured gas for other applications as part of a focus on a circular economy. Furthermore, a collaboration with GE Healthcare has received public funding from the Norwegian Research Council to move away from the current manufacturing process in order to reduce gas usage.

Social

Ethical R&D (4)

Testing of ACT pre-clinical is done by animal testing. EXACT-Tx does not perform our own animal tests, but utilizes international recognized institutions to do so. These tests are all done in accordance with guidelines that ensures ethical procedures. For EXACT-Tx, most of the tests are performed by Norwegian University of Science and Technology (NTNU) in Norway or Institute of Cancer Research (ICR)/ Royal Marsden Hospital (UK).

To ensure that the pre-clinical work made on our behalf is in accordance with local rules and regulations, we have mapped what procedures are in place at the institutions in question. Contracts between EXACT-Tx and the institutions are to be reviewed and updated if needed, to ensure that any and all work performed are in compliance with the current regulations.

Patient safety is paramount in the way clinical trials are designed and carried out, and it is our fundamental responsibility to place the well-being of the patient and volunteers by appropriately balancing risks and benefits. We want to ensure that our studies are conducted in the highest ethical manner, and EXACT-Tx always follows existing principles, regulations and guidelines to ensure the highest ethical standards in our research.

We are closely following the development of regulations related to animal testing within major regulatory bodies. Recently, a new U.S. law has eliminated the requirement that drugs in development must undergo testing in animals before being given to participants in human trials.

Privacy and data management (5)

The EU personal data protection framework as laid out in Directive (EU) 2016/680 and Regulation (EU) 2016/679 came into force in 2018. As a biotech company within the healthcare space, EXACT and/or our subcontractors and suppliers may need to store personal data as part of the business. The work to establish a robust GDPR compliance policy is ongoing, and the goal of our GDPR compliance policy work is to ensure that EXACT process and safeguard personal data in line with the Regulation (“the GDPR”). Data Processing Agreements will be established between EXACT as data controller and any data processor as required.

Precision Medicine

Precision medicine (PM) is the tailoring of medical treatment to the individual characteristics of each patient. This more effective approach toward prescribing means that, physicians can select a therapy or treatment protocol based on a patient’s molecular profile that minimizes adverse drug reactions and ensures a more successful treatment outcome

 Diversity, equality and inclusion

EXACT-Tx’s employees are at the core of the Company’s strategy and future. We aim to create a culture which appeals to high calibre employees with diverse backgrounds and experience, as we consider this to be a competitive advantage, Furthermore, the opportunity for employees to grow and develop their skills and competencies is important in retaining and developing talented leaders.

Employee wellbeing is of high importance to enhance productivity and motivation. This has been particularly evident during the global pandemic through 2020 and 2021 where the organisation demonstrated agility in ensuring appropriate arrangements were in place to enable working from home, whilst maintaining focus on wellbeing.

We encourage the development of a diverse and inclusive work environment and promotes an open and strong corporate culture with a healthy, safe and fair work environment that enables free exchange of ideas and fosters collaboration. The Company is committed to being an equal opportunity employer and to fair treatment for each of our employees throughout their time with the Company. We strictly prohibit discrimination of any form on the basis of gender, age, race, ethnic background, sexual orientation, among other diversity metrics.

Governance

Business ethics and transparency (7)

To ensure that patients, research and development partners, employees, shareholders and other stakeholders feel confident about our commitment to operate in accordance with responsible, ethical and sound corporate and business principles, the Company has established a set of ethical guidelines that are presented in its corporate governance policy as well as its personnel handbook. Material breaches of the ethical guidelines may result in termination of employment.

The Group takes a zero-tolerance stance towards corruption, money laundering and insider trading. All employees are encouraged to report any breaches of Group regulations. No incidents were reported in 2022.

Stakeholder relationship management (3)

Building strong relationships and creating trust amongst our stakeholders is essential for our success. To do so, creating platforms for dialogue between the parties is vital. We will always promote open, transparent, and clear information, and responsible, truthful, effective, and timely communication, providing regular financial, scientific, and other non-financial information about the Company and its results and actions. EXACT-Tx is aware that its technology and business is based on complex and advanced medical technology. We will therefore consciously seek to communicate such issues in a comprehensible manner to investors and other stakeholders.

Board governance

For EXACT-Tx it is important that the Board reflects the diversity of their company’s stakeholders to be more aware of their needs. This will enable the Board to assist the Company in making robust strategic decisions, in addition to controlling risks and ensuring legal compliance. Furthermore, this enables us to be well-positioned to deliver long-term value for shareholders and stakeholders. Our Board consists of five non-executive members of which two are women. The members of the Board reflect different nationalities and a breadth of competencies, including health, medicine, marketing, research, finance and ESG. Further information is provided in Annual report, the section of Principles for Corporate Governance

ESG GOING FORWARD

As a small actor in the biotech landscape, we acknowledge that we are still in the starting phase of enhancing and reporting sustainability activities and aim to strengthen our efforts in 2023. We have performed an initial impact assessment based on stakeholder inclusiveness, with the goal of identifying the most prominent environmental, social and governance (ESG) matters for the company. This work will continue in 2023.

EXACT-Tx further commits to report annually on ESG topics that are identified in the impact assessment.  Goals will be fixed by material topic, achievements and gaps will be tracked and documented, helping us understand our successes as well as areas that require more attention.

This ESG report is reviewed and endorsed by the Board of Directors.