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Immunovia

Annual Report Apr 1, 2020

3061_10-k_2020-04-01_e353fa99-3307-464e-a23a-b6596e1befd3.pdf

Annual Report

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2019 Annual Report

1

IMMUNOVIA AB (PUBL)

Annual Report 2019

Contents

Important Events During 20193
This is Immunovia 5
CEO Statement: Ready to Launch 7
Market Overview 11
Immunovia's Technology Platform 13
Our Journey to the Market 15
Immunovia's Shares 17
Sustainability Report 19
Auditor's Statement on the Sustainability Report 25
Corporate Governance Report 26
The Auditor's Examination of the Corporate
Governance Statement 37
Statutory Administration Report 38
Financial Statements 42
Group Key Indicators 43
Consolidated Income Statement 44
Consolidated Statement of Comprehensive Income 44
Comments on the Income Statement 44
Consolidated Balance Sheet 45
Comments on the Balance Sheet 46
Consolidated Statement of Changes in Equity 46
Consolidated Cash Flow Statement 47
Comments on the Cash Flow Statement47
Parent Company Income Statement 48
Parent Company Statement of Comprehensive Income 48
Parent Company Balance Sheet 49
Parent Company Statement of Changes in Equity 50
Parent Company Cash Flow Statement 51
Notes 52
Board of Directors' and Chief Executive Officer's
Certification 71
Audit Report 72
Definitions 76
Glossary 77
Shareholder information 79

About the report • This information was submitted for publication March 20, 2020.

EARLY DETECTION

• This financial statement has been produced in accordance with IFRS for the Immunovia Group, which comprises Immunovia AB and the wholly-owned subsidiaries Immunovia Incentive AB, Immunovia Inc. and Immunovia GmbH.

Contact Immunovia AB (Publ.), Medicon Village, Scheelevägen 2, 223 81 Lund, Sweden • 046-2756 000 • [email protected] For further information please contact Julie Silber, Director of Investor Relations • [email protected]

Important Events During 2019

2019 was a successful and important year for Immunovia, particularly as we reached a decisive milestone in December with the results of the "Commercial Test Model Study". The results showed 95 percent accuracy for IMMray™ PanCan–d, the company's test for the diagnosis of pancreatic cancer at a stage where the tumor can still be surgically removed. This result paves the way for significant improvement in the terms of care for patients with this deadly disease, as well as an improved survival rate. We are now focusing on launching IMMray™ PanCan–d in the United States during Q3 2020, the first blood-based test for early pancreatic cancer diagnosis.

In 2019, Immunovia continued its targeted work on commercializing the company's patented, blood-based test for pancreatic cancer, IMMray™ PanCan–d. We have successfully pursued a number of parallel processes such as prospective clinical studies, certification, accreditation and upscaling of production capacity and laboratory capacity. Selected highlights of the year:

Q1 2019:

During the first quarter 2019, Immunovia concluded that for optimal performance of the test, the samples should be stored for a maximum of 24 months. Thanks to Immunovia's large network of Key Opinion Leaders, access to fresh samples could quickly be secured. This moved the previously communicated timeline for the optimization study forward by about eight weeks and had an effect on the previous plan, which was to start sales in early 2020.

In February, Immunovia announced new cancer centers in Sweden and Spain had joined the PanFAM-1 study, broadening the ethnic and genetic diversity of the samples during the validation of IMMray™ PanCan–d.

Q2 2019:

In April, Immunovia and the University College London (UCL) announced the expansion of the prospective collection of blood samples that started with the PanSYM-1 pilot study.

Immunovia continued its strategic initiative of collaborating with primary care physicians in the US. This initiative began in 2018 with Immunovia's primary care physician training program at Fenway Park during World Pancreatic Cancer Day. The program highlighted the important role of primary care physicians in detecting the early stages of pancreatic cancer in patients. The reception was overwhelmingly positive.

In May, two cancer centers in New York and Chicago joined Immunovia's PanFAM-1, the largest prospective study to date, to contribute to the validation of the IMMray™ PanCan–d test.

In June, Immunovia announced excellent results from the optimization work on the commercial version of IMMray™ PanCan–d. The optimization work was successful and significantly improved the test results, which now show accuracy of up to 98 percent in the differentiation of stages I to IV of pancreatic cancer against the large symptomatic risk groups, i.e. patients with non-specific but concerning symptoms, including type II diabetes, where the cause is not pancreatic cancer. These results are outstanding and have never before been reported for pancreatic cancer. It was then announced that the "start of sales" milestone is planned for Q3 2020.

Q3 2019:

In July, the results of the optimization study for IMMray™ PanCan–d were presented at PancreasFest 2019, a large specialist pancreatic cancer conference. The results for IMMray™ PanCan–d in combination with CA19-9 generated extremely high accuracy, ROC AUC values, in differentiating patients with pancreatic cancer, "PDAC", from patients with PDAC-like symptoms, AUC 0.97, from healthy control subjects, AUC 0.98 and from people with type 2 diabetes, AUC 0.96. Similar results were achieved for all stages of pancreatic cancer.

In July, Erlangen University Hospital became the first cancer center in Germany to join Immunovia's global network of Key Opinion Leaders for the early detection of pancreatic cancer. In addition to Immunovia's existing collaborations, Erlangen University Hospital will provide fresh blood samples for the last two steps prior to the launch of IMMray™ PanCan–d. The head of the blood test collection is Professor Christian Pilarsky from the surgical department at Erlangen University Hospital.

In September, Immunovia held its first online webinar on IMMray™ PanCan–d with the title: "Differentiating Pancreatic Ductal Adenocarcinoma (PDAC) from individuals with symptoms suggestive of PDAC, including type II diabetes, with ROC AUC values above 0.95". A link to the webinar can be found at www.immunovia.com.

In September, Immunovia and the world-leading university hospital Beth Israel Deaconess Medical Center (BIDMC) concluded a collaboration agreement for the collection of blood samples for pancreatic cancer for IMMray™ PanCan–d.

At the end of September, Immunovia announced that the company was proceeding according to plan with its "Commercial Test Model Study" for Immunovia's IMMray™ PanCan–d, a blood-based test for the early detection of pancreatic cancer. Following the successful results of the Immunovia optimization study for IMMray™ PanCan–d, the last stages leading up to commercialization were the same: the results of the "Commercial Test Model Study", followed by verification and validation studies. After this, sales can begin during Q3 2020.

Q4 2019:

In October, Immunovia released an update on its ongoing lung cancer projects: an ongoing study scheduled to be completed during Q2 2020 and an internal program based on studies and Key Opinion Leader collaborations focused on the early detection of lung cancer.

At the end of October, Immunovia provided an update on the company's rheumatoid arthritis (RA) development project and announced that it had successfully initiated the establishment of a network of Key Opinion Leaders that will support the design of the company's RA program and provide high-quality blood samples for the various test phases required to get the test through its discovery phase.

Immunovia announced a collaboration with Professor Thomas Huizinga of Leiden University Medical Center's Rheumatology Department, for a second retrospective study to differentiate patients with RA from individuals who show RA-like symptoms caused by non-RA conditions. The study continues the work of the first study and the use of Immunovia's platform technology IMMray™, which is designed to reflect the clinical environment in which such a test would be used.

In November, Immunovia announced that the company's lung cancer collaboration had entered the next phase of development, where Immunovia will receive blood samples taken to initiate tests and analyses. The study will be completed during Q2 2020.

In December, Immunovia strengthened its management with the addition of two extremely experienced professionals: Hans Christian Pedersen was appointed Vice President Business Development and Peter Schulz-Knappe as Chief Technology Officer (CTO).

In December, Immunovia announced the excellent results of the company's "Commercial Test Model Study" conducted on blood tests from 7 different cancer centers in the US and the EU. IMMray™ PanCan–d showed excellent robustness with samples from all these centers with an accuracy of 95 percent for the test for the earliest stages, I and II. With these results, the company is proceeding according to plan for the final stages prior to the commercialization of IMMray™ PanCan–d. The results, in combination with CA19-9, confirmed the accuracy shown in the optimization study performed earlier in 2019 for the differentiation of the early stages of pancreatic cancer from patients with non-specific but alarming symptoms, including type 2 diabetes and healthy people.

This is Immunovia

Immunovia is a diagnostic company that has developed IMMray™, a proprietary platform technology that uses a simple blood-based test to help meet serious medical needs – namely the early detection of cancer where it is still treatable with a significantly better prognosis, and correctly detect autoimmune diseases.

Early Discovery is the Key to Curing Pancreatic Cancer

Pancreatic cancer is one of the deadliest forms of cancer, and the key to increasing the survival rate is early detection. Immunovia's IMMray™ PanCan–d has the potential to become the first blood-based test for the early detection of pancreatic cancer in stages I–II, when the tumor can still be surgically removed. If more patients were diagnosed at stages I and II, the five-year survival rate would be able to increase from 5-9 percent to up to 50 percent.

Operations

The company was founded in 2007 by researchers at the Department of Immunotechnology at Lund University and CREATE Health, the strategic center for translational cancer research in Lund, Sweden. Immunovia is headquartered in Lund, Southern Sweden, and has two wholly owned subsidiaries: one in the US, with an office and laboratory outside Boston, and one in Germany, with an office in Frankfurt. The company's shares were listed on Nasdaq Stockholm's main market in April 2018, and were previously listed on Nasdaq First North from December 2015.

Immunovia works actively to develop and commercialize diagnostic tools for various indications of cancer and autoimmune diseases. The first product to be launched based on the proprietary IMMray™ platform technology is IMMray™ PanCan–d, a test for the early diagnosis of pancreatic cancer. IMMray™ PanCan–d is a blood-based test that can diagnose patients in the early stages of the disease (stages I-II) with a very high rate of accuracy. For patients and physicians, early detection means not only improved treatment outcome, but also that the treatment methods currently used for pancreatic cancer have a better chance of success. Current diagnostic methods for the detection of pancreatic cancer are insufficient and ineffective, which is why IMMray™ PanCan–d has an important role to play.

The company aims to introduce the world's first highly accurate test for the early diagnosis of pancreatic cancer in Q3 2020.

Market Launch and Future Prospects

The company's launch of the first test based on the Immunovia IMMray™ platform: IMMray™ PanCan–d for the early detection of pancreatic cancer, is aimed at an estimated potential market of over USD 4.4 billion in the US and Europe.

The journey to market progressed in 2019, towards a planned sales start in Q3 2020 of IMMray™ PanCan–d to self-paying private individuals and healthcare providers ("Out of Pocket").

To achieve this, the company worked intensively on the commercialization process of IMMray™ PanCan–d during 2019. Immunovia also sees great potential in the development of tests for other unresolved problems in the areas of cancer and autoimmune diseases based on its IMMray™ platform.

IMMray® PanCan-d could become the first blood-based test for early diagnosis of pancreatic cancer

Objective

Immunovia's goal is to be the first company to launch a blood-based test for the early detection of pancreatic cancer, and that the test should become a standard of care for specialists and diabetes physicians to use in pancreatic cancer worldwide for the detection of pancreatic cancer among high-risk groups at an earlier stage than is currently possible.

Vision and Mission

Immunovia's vision is to lead the development of bioinformatic-supported diagnosis so that all patients are diagnosed in time for effective treatment, resulting in improved quality of life and a significantly higher survival rate.

Against this background, we have a dual mission:

  • Using the IMMray™ platform, to discover, develop and establish more precise and reliable tools for early diagnosis of cancer and autoimmune diseases.
  • To establish IMMray™ PanCan–d, our blood-based test for the early diagnosis of pancreatic cancer, as the global standard for the significantly earlier detection among high-risk groups.

Strategy

Immunovia's strategy is to be the first company to analyze the wealth of immunological information in blood and convert it into clinically practical tools to diagnose complex diseases earlier and more accurately than has previously been possible. Our focus is on unsolved problems within early diagnosis, monitoring of disease progression and the patient's response to treatment. These segments have particularly significant clinical benefits for patients and healthcare, where there are no current solutions, or where existing ones are insufficient, and where IMMray™ has the main competitive advantages.

Immunovia's initial goal is to introduce IMMray™ PanCan–d to the market. Since the early detection of pancreatic cancer is a major challenge for the healthcare system, Immunovia believes that there is great commercial potential in being the first to launch a blood test and thus, securing a strong position in the market.

Immunovia's strategy is to be the first company to analyze the wealth of immunological information in blood and convert it into useful tools for the diagnosis of complex diseases earlier and more accurately than has previously been possible. The focus is on unsolved problems in early diagnostics, monitoring the course of disease, and patient response to therapy.

CEO statement Ready to Launch

In December 2019, we reached a very important milestone with the results of the "Commercial Test Model Study", which showed 95 percent accuracy for IMMray™ PanCan–d, our product for diagnosing pancreatic cancer at an early stage when it is still possible to successfully remove the tumor surgically. This result paves the way for considerable improved treatment and survival rates for patients with this deadly disease. We are now fully-focused on launching our blood-based test in Q3 2020.

As we close 2019, we continue to make great strides and remain on track to launch our lead diagnostic candidate IMMray™ PanCan–d in the US market during Q3 2020. We ended the year with fantastic results from our "Commercial Test Model Study," which confirmed the very high accuracy of our test in differentiating stages I–IV of pancreatic cancer from clinically relevant control

groups that best reflect the commercial and clinical situation (i.e. patients who do not have cancer but show similarly concerning symptoms, including type 2 diabetes, as well as healthy subjects). In 2019, we not only achieved the milestones needed to advance towards the commercialization of IMMray™ PanCan-d, but we also made progress with our pipeline projects in lung cancer and autoimmune diseases.

Early Diagnosis is Crucial as Cancer Remains a Global Problem

Cancer diseases have recently overtaken cardiovascular disease as the leading cause of death in the industrialized world. With the increasing global burden of cancer, the need and demand for the detection of cancer at an early stage is growing. Healthcare systems all over the world need to adapt to a more proactive approach to care (i.e. disease prevention, early and accurate diagnosis and individualized treatments).

Regulatory authorities are adopting processes for faster approvals and new value-based payment models are being implemented. Because pancreatic cancer is one of the deadliest cancer forms and is often diagnosed too late, early detection is vital. Each year, 338,000 people are diagnosed globally, and this number is increasing at a rapid rate. IMMray™ PanCan–d, a test for the early detection of pancreatic cancer, has the potential to dramatically increase survival rates for these patients. Immunovia's goal is to be part of the revolution of early detection, a priority for all stakeholders within healthcare and society as a whole.

Early diagnosis of cancer is critical for all stakeholders – from the individual patient to society as a whole. Immunovia's diagnostics technology has the potential to provide a needed solution.

Intensified Launch Preparation

With two milestones remaining – a verification study and a final validation study – before the commercialization of IMMray™ PanCan–d during Q3 2020, we are intensifying the final launch preparations. We have successfully established a network of world-renowned Key Opinion Leaders and healthcare specialists, who have collaborated with us on how the test should be used in practice. They have also provided us with the necessary blood samples collected in a clinical setting, so that we have been able to test our IMMray™ technology. Our production is ready with increased capacity and our established quality system for operations throughout the company is being prepared for the final accreditations. Our team in the US and at the laboratory in Marlborough are working intensively on the implementation of a logistics and distribution system to provide timely test results to all our customers in the US. We have established a scalable sales and marketing organization so that we can reach the top doctors at gastric centers throughout the US. Collaborations with different patient organizations have also been a focus for us, as they play an important role in increasing awareness of the disease and supporting patients and their families.

Successful Results of "Commercial Test Model Study" Paves Way for Sales Start Q3 2020

As announced in a press release on December 19, 2019, our "Commercial Test Model Study" was successful and showed an accuracy for the test of 95 percent. The study was performed in order to finalize the commercial biomarker signature of IMMray™ PanCan–d and to confirm its accuracy in differentiating pancreatic cancer (PDAC) in stages I-IV from control groups best reflecting the clinical and commercial setting, i.e. patients with non-specific but concerning symptoms, including type II diabetes, as well as healthy individuals.

Our "Commercial Test Model Study" included a total of 1,113 samples. All these samples were freshly collected through our Key Opinion Leaders at eight clinics treating pancreatic diseases in the US and Europe. IMMray™ PanCan–d in combination with tumor marker CA 19-9 succeeded in differentiating pancreatic cancer samples for the earliest stages, I and II, with 95 percent accuracy, confirming that Immunovia's IMMray™ PanCan–d in combination with CA 19-9 enables the early detection of pancreatic cancer through a simple blood test.

Clinical Prospective Studies Program Continues as Planned

In 2019, to validate the clinical utility of IMMray™ PanCan-d, which is necessary to obtain reimbursement from the insurance system, Immunovia continued the three large prospective clinical studies covering the three main risk groups for pancreatic cancer:

• Hereditary – PanFAM-1 study

  • Diabetes diagnosed after the age of 50, PanDIA-1 study
  • Patients who exhibit symptoms that indicate pancreatic cancer PanSYM-1 study

studies in the world for these three risk groups, include 29 cancer centers in the US and Europe and more than 10,000 individuals

The three clinical studies, the largest

These three clinical studies, the largest studies in the world for these three risk groups, include 24 cancer centers in the US and Europe and more than 10,000 individuals. There is more information at www.immunovia.com. All three studies are progressing as planned and the final results are expected in 2022/2023.

Development Projects at Early Stages

In addition to our main focus on pancreatic cancer, Immunovia is conducting early-stage projects for other cancers and autoimmune diseases. These are in the earlier steps of development, known as "Discovery Studies", where Immunovia begins to build partnerships with Key Opinion Leaders to gain access to expertise about the clinical needs as well as access to high-quality blood samples including clinical information representing this. These collaborations are the most important activities for the success of the studies, forming the basis of whether to go ahead and invest in the next phase, known as "Development Studies" which lead to a product, a significantly greater financial commitment than the Discovery Studies.

Immunovia's Lung Cancer Program

Immunovia continues to make progress with its lung cancer projects. Following the initial study in 2018, which showed very promising results, the plan is to complete a second ongoing study during Q2 2020. Regarding our own stand-alone study for the early detection of cancer that will build on the results of the ongoing study, Immunovia began to build a network of Key Opinion Leaders in 2019 to gain access to high-quality fresh blood samples for the various test phases that must be completed in order to launch a test.

Immunovia's Rheumatoid Arthritis (RA) Program

Immunovia has begun to build a Key Opinion Leader (KOL) network for the RA program, an instrumental activity for obtaining high-quality blood samples as well as future key customers. The RA program aims to test whether or not Immunovia´s IMMray™ platform can differentiate between RA patients, regardless of whether they have been tested correctly using the current ("anti-CCP") standard test or incorrectly despite having RA, versus other conditions with similar symptoms like RA thus replacing the current standard CCP tests, which miss approximately 25-30 percent of all RA cases.

In 2019, Immunovia announced the first KOL collaboration with Leiden University Medical Center's Rheumatology Department, one of the leading research centers on rheumatoid arthritis in Europe. Leiden will be providing blood samples for a retrospective study and the research will be led by Professor Dr Thomas Huizinga, a world renowned authority in RA diagnosis and research.

In summary, the fantastic results published at the end of December 2019 have now enabled us to focus all our efforts on commercialization with the sales start of the market's very first test for the early discovery of pancreatic cancer commencing Q3 2020.

Process Overview: Initial Study Results to Market

Summary

In summary, the fantastic results published at the end of December 2019 have now enabled us to focus all our efforts on commercialization with the sales start of the market's very first test for the early discovery of pancreatic cancer commencing Q3 2020. We will market IMMray™ PanCan–d first in the US and then in Europe. We continue to increase the focus on our commercialization efforts to ensure a successful launch of IMMray™ PanCan–d, our first product to market. Immunovia is targeting an initial addressable market of USD 4.4 billion in the US and Europe, and we look forward to working with healthcare providers around the world to improve the situation of those affected by pancreatic cancer.

Finally, on behalf of the Board and the entire Immunovia team, we look forward to being able to make a difference to all those people affected by pancreatic cancer by launching the world's first blood test in 2020 – IMMray™ PanCan–d – for this terrible disease.

Mats Grahn CEO, Immunovia

Market Overview

Immunovia expects to generate its first income stating Q3 2020. The initial estimated market value for IMMray™ PanCan–d in the US and Europe is over USD 4.4 billion.

The launch of IMMray™ PanCan–d on the American and European market is planned to begin with self-pay patients as soon as the accreditation processes are complete. Revenue is expected from 2020. The market potential for IMMray™ PanCan–d is estimated to exceed USD 4.4 billion in the US and Europe.

Pancreatic Cancer – The Deadliest Form of Cancer

Pancreatic cancer is one of the deadliest forms of cancer and also the most difficult to diagnose because signs and symptoms arrive late and may be confused with many other diseases. It was estimated that over 45,000 people died of pancreatic cancer in 2019, and over 50,000 new cases were diagnosed in the United States alone. The current five-year survival rate for pancreatic cancer is 5-9 percent. Within a few years, pancreatic cancer is expected to be the second most common cause of death from cancer. Early discovery is therefore crucial to improving survival rates in a significant way. The five-year survival rate could potentially increase from the current 5-9 percent to up to 50 percent with early detection.

Current Diagnosis Methods Insufficient for Early Detection

All current methods are considered insufficient for early detection of pancreatic cancer. Due to the low incidence of pancreatic cancer, the costs of screening the entire population are too high. A large number of biomarkers for the early diagnosis of pancreatic cancer have also been examined and evaluated. However, no marker has yet demonstrated sufficient sensitivity and specificity to serve as a reliable screening tool. The best marker utilized at present is neither fully comprehensive nor sufficiently precise, which reduces its clinical usability as a diagnostic marker.

Three High-Risk Pancreatic Cancer Groups

Immunovia's primary market target groups consist of three risk groups, all of which suffer an increased risk of pancreatic cancer:

Patients with previous cases of pancreatic cancer in the family (hereditary pancreatic cancer), or patients with chronic pancreatitis, and patients with certain genetic changes. Immunovia estimates that there are around 200,000 such patients in Europe and the US. Immunovia's assessment is that these high-risk groups are in need of lifelong screening twice a year from the age of 40.

Patients recently diagnosed with type ll diabetes, aged 50 and over. Nearly 1 percent of all patients over 50 years of age with newly-diagnosed type ll diabetes contract pancreatic cancer within 3 years after the diabetes diagnosis, and should therefore be screened regularly during the first years after diagnosis. If pancreatic cancer has not been detected within two to three years after the initial diagnosis of type ll diabetes, pancreatic cancer can be ruled out. In this group, there are an estimated three million new patients each year in Europe and the US. If all of these were to be tested once a year for the first two years, this would mean 6,000,000 tests per year with full market penetration.

1. 2. 3.

Patients with early symptoms. It can take between six to nine months for a patient showing symptoms to be diagnosed by a specialist, from their initial contact with primary care. This period may mean that the patient's condition deteriorates from treatable to untreatable (i.e. early stage I-II becomes late stage III-IV). A blood-based test such as IMMray™ PanCan–d could exclude pancreatic cancer in most people with early symptoms, reduce the lead time for treatment for those with pancreatic cancer, thus maximizing the number of treatable patients, and increase the chances of improved survival.

Early detection is the key to improving the prognosis of cancer patients.

Increased costs in the healthcare system underline the need for early diagnosis.

A rapidly growing interest in new diagnostic technologies with the simultaneous measurement of several biomarkers.

The total annual market potential for the three high-risk groups assessed above is USD 4.4 billion, based on a cost per test of approximately \$600.

Immunovia's Technology Platform

Immunovia is developing and commercializing a standard test for the early detection of pancreatic cancer. As far as known to Immunovia, Immunovia is the first company in the world to have developed a stable, reproducible cancer diagnosis platform based on an extremely large set of specifically selected antibodies to analyze proteins in the blood.

Immunovia's Solution is a Timely One as a Result of Three Trends:

  • Early diagnosis is the key to improving the prognosis of cancer patients
  • Increased costs in the healthcare system underlines the need for early diagnosis
  • A rapidly growing interest in new diagnostic technologies with the simultaneous measurement of several biomarkers

Thanks to advanced analysis, Immunovia is able to collect data and identify changes to the immune system as the body's first reaction to illness. Unlike other existing tests, this means that the patient's actual condition can be correctly identified in the first test, despite a lack of symptoms.

Immunovia's method will be simple to use clinically and patients will only need to submit a standard blood sample, which will be sent for analysis to the Immunovia reference laboratory or possibly, in the future, to collaborative partners. The platform, which is based on complex biomarker signatures rather than individual markers, improves the reliability of the test and offers a simple yes/no answer. This enables regular testing of high-risk groups before symptoms have expressed, or in the case of vague symptoms that may indicate pancreatic cancer.

Since most deaths related to pancreatic cancer are caused by the disease being detected too late, Immunovia's solution, which enables early and easy detection, may reduce the number of deaths and improve patient survival from about 5-9 percent to 50 percent if the disease is detected at the earliest stage (stage I).

IMMrayTechnology

IMMray™ technology is based on antibodies and utilizes the immune system as an early, specific and sensitive sensor of diseases, such as cancer and autoimmune diseases. Immunovia's technology platform detects both high and low concentrations of proteins, which, unlike other technologies, for each test gives a comprehensive molecular overview. As a result of Immunovia's bioinformatics, large amounts of data can be analyzed and biomarker signatures that provide a very high degree of specificity and sensitivity can be discovered quickly and efficiently.

The IMMrayAntibody Based Microarray

Immunovia's concept of antibody based microarrays is based on microscopic droplets (on a picoliter scale) of individual antibodies in a systematic micrometer matrix on a surface smaller than a fingernail. The antibodies specifically bind to target proteins present in the blood sample and create a specific pattern. The result is that a detailed mapping of the proteins in the blood is possible.

1.

Three projects associated with diagnostic tests based on the IMMray™ platform:

A. Detection of pancreatic cancer – IMMray™ PanCan–d

B. Diagnosis of the autoimmune disease Rheumatoid Arthritis (RA) based on IMMray™ technology

C. Diagnosis of lung cancer

2.

Early-phase research projects based on the IMMray® platform, and research projects based on other patents held by Immunovia conducted within the academic community, which may be transferred to Immunovia for further research and development

If market adjustment for IMMray™ Pan-Can–d increases and the test is subject to de facto cost reimbursement, Immunovia intends to aim at more patient groups and move on to further geographical markets

Our Journey to the Market

Immunovia's current goal is to bring the first blood-based test for the early detection of pancreatic cancer – IMMray™ PanCan–d – to the market and establish the test as the standard method for clinicians worldwide for the testing of high-risk groups. This includes patients with hereditary pancreatic cancer, patients with concerning symptoms and the diabetes risk group.

During 2019, preparations were on-going for the launch in the US and Scandinavia. To achieve its established goals, Immunovia must first gain the support of Key Opinion Leaders, experienced and prominent pancreatologists, and then get gastroenterologists and diabetes doctors to use the test. Successful market penetration often depends on reimbursement from the insurance system. Towards this end, Immunovia is carrying out three prospective studies where clinical usability will be demonstrated.

Certification and accreditation of the product and processes in development, production, and laboratory operations are Immunovia's main activities in order to reach the commercial phase. Important goals were achieved during 2019, and Immunovia is working to start sales of IMMray™ PanCan–d during Q3 2020.

In the longer term, Immunovia intends to continue developing, validating and globally commercializing additional diagnostic tests based on IMMray™ technology for patient classification, early detection, as well as following the course of patient disease and response to treatment.

Market Introduction

Cost reimbursement from insurance systems is often crucial to achieving complete commercial success. Immunovia is conducting an initial launch, which means that patients and caregivers pay for the test themselves ("out of pocket"), i.e. without any subsidy or compensation, pending full reimbursement from the insurance systems, which will come from the results of the clinical prospective studies. Work on preparing for the launch intensified in 2019, and Immunovia's commercial preparation activities significantly increased throughout 2019. The company expects that initial revenues in 2020-2022 will come from patients paying for the test themselves and healthcare systems using existing budget funds.

National Guidelines

Immunovia's goal is for IMMray™ PanCan–d to become part of the national and global guidelines for the testing of special high risk pancreatic cancer groups. Immunovia's Key Opinion Leaders network enables the company to present the health economic benefits of the test and relevant data from retrospective and prospective studies to the major cancer associations in the USA and Europe.

Distribution

Immunovia's core strategy is to deliver test results from our own reference laboratories, Immunovia Dx Laboratories, and to gain access the whole market by transferring IMMray™ PanCan–d technology to appropriate partner laboratories and commercial reference laboratories when commercially appropriate.

Cost Reimbursement

Immunovia needs to demonstrate the clinical benefits and performance of IMMray™ PanCan–d, as well as the health economic advantages and improved quality of life for patients, in order to secure cost reimbursement from public and private insurance systems.

Immunovia's Shares

Share Information: Immunovia's shares were listed on Nasdaq Stockholm's main list on April 3, 2018, with the ticker IMMNOV.

The number of registered shares amounted to 19,654,853 at the end of the reporting period. The share's nominal value is SEK 0.05.

The Annual General Meeting (AGM) held on Friday, April 26, 2019 resolved to offer a warrants scheme (series 2019/2023) to employees and key persons in the Company. The share warrants (191,000, of which 47,500 have been exercised) can be exercised to subscribe for new shares in the Company from June 1, 2023 and until June 30, 2023. Each share warrant confers entitlement to subscribe for one share at a subscription price of SEK 342.06 per share. Upon full exercise, the company's share capital would increase by SEK 9,550.00.

The AGM held on Thursday, May 3, 2018 resolved to offer a warrants scheme (series 2018/2021) to employees and key persons in the Company. The warrants (156,150) can be exercised to subscribe for new shares in the Company from September 7, 2021 and until October 7, 2021. Each warrant gives entitlement to subscribe for one share at a subscription price of SEK 271.05 per share. Upon full exercise, the company's share capital would increase by SEK 7,807.50.

The AGM held on Tuesday, April 25, 2017 resolved to offer a warrants scheme (series 2017/2020) to employees and key persons in the Company. The warrants (61,000) can be used to subscribe for newly issued shares in the Company during the utilization period from September 15, 2020 until October 15, 2020. Each share warrant confers entitlement to subscribe for one share at a subscription price of SEK 205.00 per share. Upon full exercise, the company's share capital increases by SEK 3,050.00.

The AGM held on Friday, April 26, 2019 resolved on an alternative cash-based incentive scheme for employees and key individuals based in countries where the share warrant program designated series 2019/2023 was not suitable. Such an incentive scheme has been introduced for employees and key individuals and is designed so that the economic effects correspond to the terms of the 2019/2023 warrants scheme. The total cost to the Company for the cash-based incentive program will not exceed USD 520,000.

The AGM held on Thursday, May 3, 2018 resolved on an alternative cash-based incentive scheme for employees and key individuals based in countries where the share warrant program designated series 2018/2021 was not suitable. Such an incentive scheme has been introduced for employees and key individuals and is designed so that the economic effects correspond to the terms of the 2018/2021 warrants scheme. The total cost to the Company for the cash-based incentive program will not exceed USD 250,000.

The AGM held on Tuesday, April 25, 2017 resolved on an alternative cash-based incentive scheme for employees and key individuals based in countries where the share warrant program designated series 2017/2020 was not suitable. Such an alternative incentive program has been introduced for 6 key persons and is designed to reflect the terms of the warrants program 2017/2020 in its financial effect.

The total cost to the Company for the cash-based incentive program will not exceed USD 920,000. All warrant programs are subject to customary recalculation terms in connection with share issues, etc.

Dividend Policy

Cost reimbursed sales

Immunovia has not adopted a dividend policy.

Proposed Dividend

The Board of Directors is proposing to the AGM 2020 that no dividend is paid for the financial year 2019.

The number of registered shares amounted to 19,654,853 at the end of the reporting period. The share's nominal value is SEK 0.05.

Share Capital Development

Year Event Total Share
Capital (SEK)
Change
(SEK)
Total No. of
Shares
Change
Shares
Nominal
Value
(SEK)
5/24/2007 Formation 100,000.00 100,000.00 1,000,000 1,000,000 0.10
10/19/2011 New share issue 105,263.00 5,263.00 1,052,630 52,630 0.10
10/27/2011 Share split 5:1 105,263.00 - 5,263,150 4,210,520 0.02
7/5/2012 New share issue 108,869.92 3,606.92 5,443,496 180,346 0.02
5/21/2013 New share issue 122,483.76 13,613.84 6,124,188 680,692 0.02
9/10/2013 New share issue 124,899.76 2,416.00 6,244,988 120,800 0.02
6/5/2014 New share issue 220,924.32 96,024.56 11,046,216 4,801,228 0.02
8/13/2015 Bonus issue 552,310.80 331,386.48 11,046,216 - 0.05
12/17/2015 New share issue 714,560.80 162,250.00 14,291,216 3,245,000 0.05
9/15/2016 New share issue 823,728.40 109,167.60 16,474,568 2,183,352 0.05
10/17/2016 New share issue 840,202.95 16,474.55 16,804,059 329,491 0.05
10/4/2017 New share issue
via warrants
865,902.95 25,700.00 17,318,059 514,000 0,05
6/8/2018 New share issue 974,042.65 108,139.70 19,480,853 2,162,794 0.05
9/19/2018 New share issue
via warrants
976,567.65 2,525.00 19,531,353 50,500 0.05
9/9/2019 New share isuue
via warrants
982, 742.65 6,175.00 19,654,853 123,500 0.05
12/31/2019 982, 742.65 19, 654 ,853 0.05

The Ten Largest Shareholders as of December 31, 2019

Name No. of Shares Share Capital and Votes
Carl Borrebaeck 1,709,900 8.70%
Ålandsbanken on behalf of owners 1,680,839 8.55%
Handelsbanken Svenska Småbolag 1,100,000 5.60%
Sara Andersson Ek 888,950 4.52%
Mats Ohlin 888,950 4.52%
Christer Wingren 820,586 4.17%
Vincent Saldell 707,183 3.60%
Försäkringsbolaget Avanza Pension 575,334 2.93%
Swedbank Robur Folksams LO Sverige 565,000 2.87%
Mats Grahn 365,039 1.86%
Ten largest shareholders 9,301,781 47.33%
Others 10,353,072 52.67%
Total 19,654,853 100.00%

Sustainability Report

This sustainability report refers to financial year 2019 and applies to the parent company Immunovia AB (Publ.) (org. no.556730-4299) and all entities consolidated in Immunovia's consolidated accounts for the same period. These are stated in Note 21 of the Annual Report 2019. This report has been prepared without Immunovia having any legally mandatory requirement to do so. The report is not based on any specific sustainability standard but is based on the regulations of the Annual Accounts Act.

The Board of Directors and CEO have also approved the sustainability report when signing off the annual report and the consolidated accounts.

Immunovia's sustainability work also looks at the global goals for sustainable development, adopted in 2015 by the UN General Assembly. By working towards these goals where contact areas exist, we also achieve sustainable development in them. As Immunovia's operations are expanding, a materiality analysis is carried out in which areas of sustainability will be the starting point for forthcoming sustainability work.

Sustainability Work's Three Focus Areas

Year Event

10/4/2017

9/19/2018

New share issue

New share issue

9/9/2019 New share isuue

Total Share Capital (SEK)

Change (SEK)

via warrants 865,902.95 25,700.00 17,318,059 514,000 0,05

via warrants 976,567.65 2,525.00 19,531,353 50,500 0.05

via warrants 982, 742.65 6,175.00 19,654,853 123,500 0.05

6/8/2018 New share issue 974,042.65 108,139.70 19,480,853 2,162,794 0.05

12/31/2019 982, 742.65 19, 654 ,853 0.05

Name No. of Shares Share Capital and Votes Carl Borrebaeck 1,709,900 8.70% Ålandsbanken on behalf of owners 1,680,839 8.55% Handelsbanken Svenska Småbolag 1,100,000 5.60% Sara Andersson Ek 888,950 4.52% Mats Ohlin 888,950 4.52% Christer Wingren 820,586 4.17% Vincent Saldell 707,183 3.60% Försäkringsbolaget Avanza Pension 575,334 2.93% Swedbank Robur Folksams LO Sverige 565,000 2.87% Mats Grahn 365,039 1.86% Ten largest shareholders 9,301,781 47.33% Others 10,353,072 52.67% Total 19,654,853 100.00%

5/24/2007 Formation 100,000.00 100,000.00 1,000,000 1,000,000 0.10 10/19/2011 New share issue 105,263.00 5,263.00 1,052,630 52,630 0.10 10/27/2011 Share split 5:1 105,263.00 - 5,263,150 4,210,520 0.02 7/5/2012 New share issue 108,869.92 3,606.92 5,443,496 180,346 0.02 5/21/2013 New share issue 122,483.76 13,613.84 6,124,188 680,692 0.02 9/10/2013 New share issue 124,899.76 2,416.00 6,244,988 120,800 0.02 6/5/2014 New share issue 220,924.32 96,024.56 11,046,216 4,801,228 0.02 8/13/2015 Bonus issue 552,310.80 331,386.48 11,046,216 - 0.05 12/17/2015 New share issue 714,560.80 162,250.00 14,291,216 3,245,000 0.05 9/15/2016 New share issue 823,728.40 109,167.60 16,474,568 2,183,352 0.05 10/17/2016 New share issue 840,202.95 16,474.55 16,804,059 329,491 0.05

Total No. of Shares

Change Shares

Nominal Value (SEK)

Public Welfare Sustainable Products and Processes Sustainable Workplace

PUBLIC WELFARE

Immunovia's Value Chain

Immunovia's ambition is to create value by being able to diagnose complex diseases such as cancer and autoimmune disorders, considerably earlier and more precisely than is currently possible.

RESEARCH

Basic research is carried out at an academic level Built on thorough

ethical research. Development takes place in collaboration with leading clinics and research centers in the cancer and autoimmune areas

PRODUCT DEVELOPMENT

PURCHASE AND PRODUCTION

Production of antibodies in accordance with regulatory requirements.

Suppliers undergo Immunovia's approval process

DIAGNOSTICS

Diagnosis of cancer and autoimmune diseases in accordance with regulatory requirements. The test is analyzed by Immunovia's IMMray platform

CUSTOMER

Early detection of cancer and autoimmune diseases contributes to better treatment and increased survival. Sales of the first test start in Q3 2020

Business Model and Operation

In our therapeutic core areas – cancer and autoimmune diseases – we address several of society's largest global health challenges and strive to develop more effective diagnostic tools that help improve treatment, quality of life and health economics. Thorough, safe and ethical research is one of the company's cornerstones ensuring both patient safety in clinical trials and that our products are clinically useful with a positive health economic effect.

Immunovia's strategy is to analyze the wealth of information that is in blood and transfer it to clinically useful tools in order to diagnose complex diseases such as cancer and autoimmune disorders considerably earlier and more accurately than is currently possible. Immunovia's Technology Platform – IMMray™ – is an antibody based multiplex test designed to generate immune defense response snapshots from the information in a single drop of blood.

The IMMray™ platform is a systematic approach, based on the simultaneous measurement of many proteins in the blood with the very latest bioinformatics, aimed at detecting the most clinically relevant changes that may occur in the blood and combining them into a biomarker signature – a kind of "disease fingerprint" – which is specific to each disease.

Social Value Chain

The prerequisite for sustainable business development and success lies in creating long-term relationships with our employees, customers and suppliers. In order to build up our good reputation, we must maintain high quality and high ethical levels in all our commitments, with a given respect for fundamental human rights.

Collaboration with partners is key to Immunovia's success. Major scientific breakthroughs are often done through collaboration between industry and academia. Working with world-renowned research centers and clinics provides the necessary access to patient samples and data, as well as crucial clinical expertise.

We also value our close relationships with Key Opinion Leaders and patient organizations, as they provide an important insight, knowledge and ability to influence change. Since 2016, Immunovia has been affiliated with the World Pancreatic Cancer Coalition (WPCC), a world coalition between over 50 patient organizations for pancreatic cancer. Our goal is to be a responsible player.

Vision and Mission

Immunovia's vision is that we shall lead the development of bioinformatic-supported diagnosis so that all patients are diagnosed in time for effective treatment, resulting in improved quality of life and a significantly higher survival rate.

Against this background, Immunovia has a dual mission:

1.Using the IMMray™ platform discover, develop and establish more precise and reliable tools for early diagnosis of cancer and autoimmune diseases

  1. Establishing IMMray™ PanCan –d - our blood-based test for early diagnosis of pancreatic cancer – as a global standard for much earlier discovery in high-risk groups

Immunovia's vision and mission are well in line with the UN's global health and wellness goals, where one of the goals is to reduce the number of deaths due to non-communicable diseases by one third.

Anti-Corruption

Business ethics is important and is an issue that is continuously managed and treated. Anti-corruption guidelines are regulated in Immunovia's Code of Conduct. We have a pronounced zero tolerance to corruption and do not accept bribes or unfair anti-competitive measures. No cases of corruption were detected during the year.

Whistle-Blowing System

It is of the utmost importance for Immunovia that the entire company's operations are conducted with the highest possible sense of responsibility, openness and honesty. Any suspicion of fraudulent behavior, bribery or other similar situations witnessed, must be reported promptly.

During 2019 various whistle-blower systems were evaluated and a whistle-blower function will be implemented in 2020. This is to enable all employees to feel confident in reporting irregularities, maladministration and serious events without worrying about negative consequences. As the organization grows, more focus will be placed on measures against anti-corruption.

Significant Risks and Risk Management – Public Welfare

Risk Risk Management
The company's tests will
not be covered by national
guidelines for treatment
or by cost compensation
programs.
The company works actively to get tests in cancer and the
autoimmune area covered by national and medicinal organi
zational guidelines for testing in high risk groups. This work
is carried out, amongst others, in the form of lobbying and
through the company's network of Key Opinion Leaders.
Immunovia works in a
competitive environment.
The market where Immunovia operates in is subject to com
petition and the company competes with Swedish and inter
national companies which, like Immunovia, focus on diagno
sing cancer and autoimmune diseases. The company conducts
ongoing external monitoring of competitors and technology.
Immunovia is subject to
various government
regulations and risks not
getting the necessary per
mits for the sale of tests.
Immunovia's operations are, among other things, subject to
US, European and local laws, rules and regulations, which,
inter alia, concern medical technology products. In order to
market and sell medical technology products, permits and/or
approvals must be obtained and registered with the relevant
authorities.
There is a risk that Im
munovia will not receive
cooperation and license
agreements with different
countries' reimbursement
systems.
The company conducts work on its own behalf and signs agre
ements with partners to conduct research, retrospective and
prospective studies in various research projects and commer
cialize their products. The company ensures through coope
ration agreements with key partners' insight into different
countries' reimbursement systems that
make it possible to adapt the company's management of tests
for different markets.

SUSTAINABLE PRODUCTS AND PROCESSES

Quality Systems and Registrations

The creation of the quality system forms the basis of the business for obtaining the necessary permits and registrations which then enable future sales. Immunovia works intensively to get product registrations according to EU IVD directive, ISO 13485, accreditation of Immunovia's laboratory in Lund according to ISO 17025, and CLIA /CAP accreditation of Immunovia Inc's lab in Marlborough, MA, USA will be in place as soon as possible. Furthermore, we are preparing for future FDA approval of our diagnostic products.

Innovation, Product Development, Purchasing And Production

Innovation and technological advances are key to finding sustainable solutions for both economic and environmental challenges. It also contributes to creating new jobs and markets that can contribute to an efficient and equitable use of resources. Investing in sustainable research and innovation is an important way of creating the conditions for sustainable development.

Routines and processes in product development and manufacturing are prepared in accordance with the regulatory requirements imposed on the business. The focus is on ensuring that product quality, traceability and the systematic work on energy-efficient processes preserve the quality of Immunovia's products and services.

Chemicals

Risk assessments are made on all chemicals used to produce a product. The waste generated by the business is managed and destroyed according to applicable laws and regulations. Clinical waste (infectious/sharp/cutting waste), GMM waste (genetically modified micro-organisms) and solvents, are managed and destroyed in cooperation with certified waste companies.

Minimal Environmental Impact

Immunovia's goal is to lead the Group's operations with as little negative impact on the environment as possible while ensuring correct results to the tests being done.

Immunovia strives to improve its environmental performance by:

  • Destroying waste complying with Immunovia's waste management policies
  • Complying with legal and other relevant requirements
  • Minimizing the environmental impact of energy consumption and transport

Our quest to continuously minimize our environmental impact is self-evident. Immunovia does not actively measure its environmental impact, in the form of CO2 emissions, which the business generates. Management does not consider there are significant risks that can have negative consequences for the business associated with these factors, that require measurement.

To minimize the environmental imprint, travel is restricted and digital meetings are prioritized.

Supplier Evaluations Ensure the Sustainability of Our Value Chain

Immunovia conducts supplier evaluations in accordance with the evaluation policy in force at any time. The purpose of the supplier evaluations is to ensure, as far as possible, that Immunovia works with suppliers that provide quality-assured products, which in turn contribute to the reliability of the test responses and thus contribute to safeguarding the sustainability of the value chain. The ambition is to work with our suppliers and regularly review these in order to continuously ensure quality.

Significant Risks and Risk Management – Sustainable Products and Processes

Risk Risk Management
Immunovia's product
development does not
succeed in meeting
market and/or quality
requirements.
Through structured and goal-oriented work in the various areas,
the possibility of successful product development increases.
Information exchange takes place continuously with the marke
ting and quality department to meet the market and regulatory
requirements that are set.
Risks linked to intel
lectual property rights.
Immunovia's intellectual property rights, in particular its patents,
constitute an important asset in the business and the company's
success depends on the company being able to maintain the
reputation and value associated with the company's existing
patents, brands and other intellectual property rights. In order to
ensure that new patents are created, staff are encouraged and
given the opportunity to register patents that are then trans
ferred to the company's name. Management of applications and
monitoring of existing patents is continuously done by a patent
agency engaged by the company.
Risk that accredita
tion according to ISO
17025 and CLIA/CAP
accreditation in the US
are not received.
Immunovia focuses heavily on the regulatory requirements
required to obtain the necessary accreditation of the company's
laboratories. Necessary in this is the company's quality system
where the company engages in internal and external resources
with the experience of building a quality system that enables
accreditation. Parallel to this, changes are being made by the
registration authorities.
Risk that the necessary
product registrations
are not received.
Immunovia works in a targeted way with the regulatory requi
rements set for obtaining the necessary registrations. Central to
this is the company's quality system, where the company engages
both internal and external resources with many years of expe
rience of building quality systems and getting these approved.
At the same time, changes are being made by the registration
authorities, such as the FDA.

SUSTAINABLE WORKPLACE

Our Most Important Asset Is Our Employees

Immunovia's employees are an absolute prerequisite for our success. A good corporate culture makes for well-being, low sick leave and good relations, as well as low staff turnover. Immunovia should be a company where responsibility and freedom should be two of its core values and can be summarized as "freedom in responsibility".

Equality between men and women is a prerequisite for sustainable and peaceful development. Equality is about a fair distribution of power, influence and resources.

Immunovia is a gender equal company and in the Albright Report 2019 entered the green list at 45th of 327 listed companies regarding gender equality between men and women.

The Albright report annually ranks the listed companies from best to worst in promoting women to the management team. The gender equal companies are listed on Albright's green stock exchange list, the mediocre companies are placed on the yellow stock market list and the male-dominated companies end up on the red list.

During 2019, the average number of employees in the Group was 48 (39), of which 38 (32) were in the parent company. The average number of women in the Group was 31 (27) and the average number of men in the Group was 17 (12). Immunovia's management group consists of 4 men and 3 women.

Education and Expertise

A prerequisite for a successful business is to make use of the employees' knowledge, experience and commitment. Immunovia should therefore be a workplace in which all employees' knowledge, skills and expertise are utilized in the best way. Through internal training and needs-tested external training, the expertise level is continuously raised at the company.

Health and Safety

Health and safety is a priority area. Immunovia has a zero tolerance regarding work-related accidents, illnesses and incidents and an ambition to continuously promote improved health and well-being among our employees. The goal is for nobody to suffer from physical or mental illness due to their work situation. No occupational injuries were reported in 2019.

Adaptations are continually being made to the new legislation concerning the GDPR (General Data Protection Regulation).

Respect For Human Rights

Immunovia has no business in environments where a lack of human rights is considered a risk. We have therefore assessed that our operations have a limited impact on human rights and have therefore not set any goals for them. All employees are expected to comply with laws and ethnic standards and have a professional outlook both internally and externally.

Employee Turnover

We strive to make our employees feel comfortable and develop in order to maintain key expertise and recruit new talent. In 2019, 6 (9) new employees started at Immunovia and 2 (0) employees left. Immunovia is a young company where most of the staff have been hired over the last four years.

Work Environment

Ongoing work on the work environment must be preventive, supportive and encouraging. Preventive – through regular work environment inspections, minimizing risks of accidents/ill-health and ongoing follow-up of activities. Supportive – by regularly carrying out employee surveys on the work climate, job satisfaction and commitment. Encouraging – by offering employees opportunities for developing and promoting openness, equality and responsibility. Of course, we have zero tolerance to bullying and harassment.

Diversity

We are convinced that diversity - including a mixture of gender, age, ethnic background and sexual orientation - contributes in the long-term to a better working environment, greater creativity and better results. Furthermore, we will never accept prejudice or discrimination in any form, but strive for equal treatment for all, regardless of background and individual differences. Equality between men and women is a prerequisite for sustainable development and is about a fair distribution of power, influence and resources.

Immunovia has adopted the following principles to ensure diversity and equal treatment:

  • Promote diversity
  • Equal treatment regardless of background or individual differences
  • Zero tolerance against discrimination
  • Adapt facilities for accessibility for disabled employees

IMMUNOVIA AB (PUBL) Annual Report 2019 25

Risk Risk Management
Risk that key people
leave the organization.
The company's ability to continue to identify and develop oppor
tunities depends on the key employees' knowledge and exper
tise in the area that Immunovia operates. By creating a good,
interesting and challenging workplace where key individuals are
given the opportunity to develop within their area, the company
ensures that key people want to work at the company.
Men
34%
Women
66%
Work environment
risks.
Immunovia works actively for a good work environment where
physical, organizational and social aspects are in focus. Examp
les of preventive activities include the annual health profiles
and provision of health insurance and ergonomic reviews of the
workplace.
Gender distribution
Immunovia 2019
Risk of access to the
right skills not being
met.
Immunovia is a knowledge-intensive company dependent on
people with high skill levels and experience to achieve planned
success. By being an attractive employer providing market-based
and competitive remuneration, this contributes to new employ
Men
57%
Women
43%
ees being recruited and retained. Gender distribution
management group 2019

Significant Risks and Risk Management – Sustainable Workplace

Sustainable Development – A Summary

Sustainable development is a common concept for the environment, labor laws, social conditions, human rights and anti-corruption. Long-term economics is also included as a criterion.

The concept of Sustainable Development was launched by the UN's Brundtland Commission, which in 1987 defined it as a development that: "... meets today's needs without jeopardizing the ability of future generations to meet their needs."

Auditor's Statement on the Sustainability Report

To the general meeting of Immunovia AB (Publ.), Corporate identity number 556730-4299

Engagement and Responsibility

It is the Board of Directors who is responsible for the statutory sustainability report on pages 19-25 and that it has been prepared in accordance with the Annual Accounts Act.

The Scope of the Audit

My examination has been conducted in accordance with FARs recommendation RevR 12 Auditor's opinion on the statutory sustainability report. This means that our examination of the statutory sustainability report is substantially different and less in scope than an audit conducted in accordance with International Standards on Auditing and generally accepted auditing standards in Sweden. I believe that the examination has provided us with sufficient basis for my opinion.

Opinion

A statutory sustainability report has been prepared.

Lund March 20, 2020

Mats-Åke Andersson Authorized Public Accountant

"... meets today's needs without jeopardizing the ability of future generations to meet their needs."

Corporate Governance Report

This Corporate Governance Report is prepared in accordance with Chapter 6. §6 of the Swedish Annual Accounts Act and the Swedish Code of Corporate Governance (the "Code").

The Board of Directors is responsible for the Corporate Governance Report. The Corporate Governance Report for the financial year has been reviewed by the company's auditor, which is described in the "Auditor's examination of the corporate governance statement". Immunovia is a Swedish public limited company, whose shares are listed for trading on Nasdaq Stockholm's main list. Immunovia complies with the corporate governance guidelines stated in internal and external rules and ordinances. In its capacity as a limited company listed on Nasdaq Stockholm, Immunovia is regulated by the Swedish Companies Act and the Swedish Annual Accounts Act, other applicable Swedish and foreign laws and regulations, including Nasdaq Stockholm's Rulebook for Issuers.

To ensure compliance with all applicable legal standards, Immunovia has also adopted internal instructions and policies, which are reviewed below. The Board of Directors has also adopted and implemented Rules of Procedure for its work, and adopted instructions for the Chief Executive Officer, with instructions for financial reporting.

Compliance with the Swedish Code of Corporate Governance

The Code is available at the website of the Swedish Corporate Governance Board, which manages the Code (www.corporategovernanceboard.se). The Code is based on the principle of 'follow or explain,' which means that companies applying the Code may depart from individual rules, but if so, must give an explanation for the departure.

Immunovia had no departures from the Code during the 2019 financial year. There are three alternative, outstanding, cash-based incentive schemes that, as far as practicable, meet the terms of the corresponding outstanding warrants program. The alternative cash-based incentive schemes are for participants in countries where the granting of warrants is not appropriate.

Corporate Governance

The figure describes the central bodies in Immunovia's corporate governance model and who appoints the central bodies.

The Company's Governing Bodies

Articles of Association

Immunovia's Articles of Association, which are the basis of governing the company's operations, state the company's name, registered office, the aim of business operations, the company's shares and share capital, and also include rules governing shareholders' meetings. The Articles of Association state no limitations in terms of how many votes each shareholder is entitled to cast at shareholders' meetings, nor any stipulations regarding appointing and dismissing Directors, or amending the Articles of Association. The Articles of Association are stated at http://immunovia.com/sv/om-oss-2/ bolagsstyrning/bolagsordning/.

Shares and Shareholders

The total number of shares and votes of the company as of December 31, 2019 was 19,654,853, and the share capital was SEK 982,742.65. Shares in the company are all of the same class, each share carries one vote, and all shares confer equal entitlement to the company's assets and earnings. The company had approximately 4,000 shareholders as of December 31, 2019. The company's largest shareholders as of December 31, 2019 are listed on page 18.

According to the company's knowledge, all other significant relationships between Immunovia and the company's largest shareholders are listed in Note 28 titled "Transactions with related parties". The Board of Directors is not aware of any shareholders' agreements or other agreements regarding voting rights or other shareholders' rights.

In September 2019, 123,500 warrants were exercised, which were part of the company's incentive scheme decided on in 2017. The number of shares in the company increased by 123,500.

Annual General Meeting

The AGM is the company's chief decision-making body. The AGM should be held within six months of the end of the financial year. The AGM elects the Board of Directors and auditors. The AGM also adopts the Income Statement and Balance Sheet, and considers matters of the dividend, discharging the Directors and Chief Executive Officer from liability, and approving fees to the Board of Directors and auditors. The AGM also deals with matters that are incumbent on it pursuant to the Swedish Companies Act and the Articles of Association.

The company's ambition is for the AGM to be a satisfactory body for shareholders, and accordingly, its objective is for the whole Board, at least one representative of the Nomination Committee, the Chief Executive Officer and other members of management, as well as the auditor, to always attend the AGM.

Extraordinary General Meetings (EGM) are convened when the Board of Directors or auditors consider this appropriate.

Pursuant to Immunovia's Articles of Association notices convening AGMs and EGMs are through an announcement in the Swedish Official Gazette, and by making the notice available on the company's website. Issuance of the convening notice is announced in the Swedish daily newspaper Dagens Industri. Resolutions of meetings are published in press releases and are available on the website. The 2020 AGM will be held at 16.00 p.m. on May 7 at Medicon Village in Lund, Sweden.

Entitlement to Attend the AGM

All shareholders directly registered in the share register maintained by Euroclear Sweden AB five days prior to the AGM and have notified the company of their intention to attend (with potential assistants) by no later than the date stated in the convening notice of the AGM, are entitled to attend the AGM and vote for the number of shares they hold. Shareholders can attend the AGM personally or by proxy and may also be assisted by a maximum of two people. Normally, shareholders are able to register in several different ways, as stated in the convening notice.

Initiatives from Shareholders

Shareholders that wish to have a matter considered at the AGM must submit a written request thereof to the Board. The Board should normally have received such request by no later than seven weeks prior to the AGM.

Nomination Committee

The company shall have a nomination committee with the task of preparing and submitting proposals for the AGM, and in certain cases, extraordinary general meetings, resolutions in election and remuneration issues, and, where applicable, procedural issues for the next election committee.

The nomination committee shall propose:

  • the chairman of the AGM;
  • candidates for the post of chairman and other members of the board;
  • fees and other remuneration for board assignments to each of the board members;
  • remuneration to members of committees within the board;
  • election and remuneration of the company's auditor;
  • and principles for the Nomination Committee.

The Nomination Committee shall, when assessing the Board's evaluation and in its proposals, take into account the requirement on the versatility and breadth of the board and the requirement to strive for an even gender balance. Nomination Committee members, regardless of how they have been appointed, shall exercise all of the company's shareholders' interests.

Any changes in the composition of the Nomination Committee shall be released immediately.

The Nomination Committee, which will be appointed for the period until a new Nomination Committee has been appointed, should consist of four members, three of whom should be appointed by the company's largest shareholders in terms of the votes, and the fourth should be the Chairman of the Board. When evaluating which shareholder should be considered the largest shareholder of the company, calculations of participating interest should include ownership based on groups of shareholders that collaborate in the company's administration.

As soon as possible after the end of the third quarter each year, the Chairman of the Board should contact the three largest shareholders at this date in an appropriate manner and encourage them to designate the individual such shareholder wishes to appoint as a member of the Nomination Committee in writing within a reasonable time that does not exceed 30 days. If one of the three largest shareholders does not exercise its right to appoint a member of the Nomination Committee, the next shareholder in turn will be offered the right to appoint a member of the Nomination Committee. In cases where several shareholders decline the entitlement to appoint members of the Nomination Committee, the Chairman of the Board should not need to contact more than eight shareholders, providing this is not necessary to compose a Nomination Committee with at least three members. Unless otherwise agreed between members, the Chairman of the Nomination Committee should represent the largest shareholder.

The Chairman of the Board or other Directors may not serve as Chairman of the Nomination Committee.

Employees of the Group may not be members of the Nomination Committee.

If a shareholder that has appointed a member of the Nomination Committee is no longer one of the company's three largest shareholders in the year, the member selected by such a shareholder should leave the Nomination Committee. Instead a new shareholder from amongst the three largest shareholders will be entitled, independently and at their own discretion, to appoint a member of the Nomination Committee. However, no marginal differences in shareholdings and changes to shareholdings arising later than three months prior to the AGM should cause any changes to the composition of the Nomination Committee, unless in special circumstances.

If a member of the Nomination Committee leaves before the Nomination Committee has completed its assignment due to reasons other than those stated in the preceding paragraph, that shareholder that appointed such member shall be entitled, independently and at their own discretion, to appoint a replacement. If the Chairman of the Board leaves the Board of Directors, his/ her replacement should also replace the Chairman of the Board on the Nomination Committee. No fees are payable to members of the Nomination Committee. However, the company will meet expenses that the Nomination Committee considers necessary to complete its assignment.

The current Nomination Committee members are:

  • Sara Ek appointed by Sara Ek, (Chairman)
  • Carl Borrebaeck appointed by Carl Borrebaeck,
  • Astrid Samuelsson appointed by Handelsbanken Fonder, and
  • Mikael Petersson appointed by Michael Löfman

The composition of the Nomination Committee must be published on the company's website no later than six months before the AGM.

AGM 2019

The most recent AGM was held on April 26 at Medicon Village in Lund. The meeting resolved to re-elect the Directors Carl Borrebaeck, Hans Johansson, Ann-Christine Sundell, Mimmi Ekberg and Christofer Sjögren. Board member Åsa Hedin declined re-election. It resolved that total remuneration of SEK 1,120,000, be paid of which SEK 400,000 to the Chairman of the Board and SEK 150,000 to each of the other members of the Board and SEK 40,000 to the Chairman of the Audit Committee, SEK 40,000 to the Chairman of the Remuneration Committee and 20,000 SEK each to other member of these committees.

The proposal that no dividend be paid for the financial year 2018 was approved.

It was decided to elect Authorized Public Accountant Mats Åke Andersson as Chief Auditor with Authorized Public Accountant Martin Gustafsson as Deputy Auditor, for the period up to the end of the 2020 Annual General Meeting.

Furthermore, it was decided to appoint a Nomination Committee for the next AGM, in accordance with the above section "Nomination Committee".

A decision was made by the AGM to issue a maximum of 191,000 options with deviation from the shareholders' preferential rights. The options are one of Immunovia's incentive schemes for senior executives and employees and are described in more detail under Note 10.

The Meeting also resolved to grant the Board of Directors the right to introduce an alternative cash-based incentive scheme for key individuals based in countries where the allocation of warrants is not appropriate for various reasons. Such an alternative incentive scheme has been introduced for 11 key people and is designed in such a way that its economic effect for the key person, corresponds to the terms of the above-mentioned incentive scheme based on warrants and are described in more detail under Note 10. The total cost for the Company for such alternative incentive schemes must not exceed USD 520,000.

The AGM further resolved that, to make it possible for the Board to add working capital to the company and/or new owners of strategic importance for the company, and/or acquisition of other companies or businesses, to authorize the Board during the period until the next AGM on one or more occasions, to decide on a new share issue so that an increase in the share capital will be no more than twenty (20) percent based on the company's total share capital at the AGM 2019, with or without deviation from shareholders' preferential rights and with or without a provision for a capital contribution.

The Board of Directors

The Board of Directors is the chief decision-making body after the AGM. The responsibilities of the Board of Directors are regulated through means including the Swedish Companies Act, the company's Articles of Association and other laws and ordinances, as well as the Board of Directors' Rules of Procedure and other internal policies.

Pursuant to the Swedish Companies Act, the Board of Directors is responsible for the company's administration and organization, which means that the Board is responsible for matters including setting goals and strategies, ensuring procedures and systems for evaluating established goals, continuously evaluating Immunovia's financial position and results of operations, as well as appraising executive management. The Board of Directors is also responsible for ensuring that the Annual Accounts and Consolidated Accounts, as well as interim reports, are prepared on time. The Board also appoints the CEO.

The Directors are elected by the AGM each year, or where appropriate, by an EGM, for the period until the end of the next AGM. The Chairman is elected by the AGM, or where appropriate, an EGM, and has a special responsibility to lead the work of the Board of Directors and for the work of the Board being well organized and conducted effectively.

The Board of Directors follows written Rules of Procedure, which are reviewed yearly and adopted at the Board meeting following election each year, or as necessary. The Rules of Procedure divide responsibilities for the work of the Board between the Board and its Committees, and between the Board and the CEO. Pursuant to the Articles of Association, the Board should decide on strategies

and budgets, adopt the Annual Accounts and other financial statements, important policies and authorization lists, appoint the CEO and appraise the work of the CEO, adopt rules governing internal controls and monitoring how internal controls are functioning, decide on major investments and far-reaching agreements, decide on the direction of the work of the Board of Directors, appoint the Audit and Remuneration Committees, and appraise the work of the Board's Committees.

The Chairman of the Board leads the work of the Board. The Chairman of the Board should monitor the company's progress and ensure that the Board receives the information necessary for the Board to perform its duties.

The Board meets in accordance with an annual schedule that is approved in advance. In addition to these meetings, further meetings can be arranged to deal with issues that cannot be considered at a scheduled meeting. In addition to Board meetings, the Chairman and CEO maintain an ongoing dialogue regarding management of the company.

The Work of the Board of Directors

Board meetings are prepared by the Chairman of the Board jointly with the company's CEO. Written material is provided to the Board for each meeting. Certain matters are consulted within the audit committee, whose members are Christofer Sjögren (Chairman) and Hans Johansson. Regular issues for Board meetings include reviews of business conditions and financial reporting. The minutes of Board meetings are recorded by the company's CFO.

Appraising the Work of the Board

Pursuant to the Articles of Association, the Board appraises its work each year. The work of the Board is evaluated yearly through a systematic and structured process that is designed to produce good supporting data for improvements of the Board's own work. The appraisal is conducted partly individually, and partly through discussions at Board meetings. The aim of the appraisal is to provide the Chairman of the Board with information on how Directors perceive the efficiency and aggregate competence of the Board, and if there is a need for changes within the Board. The other Directors appraise the Chairman of the Board. The Chairman of the Board informs the Nomination Committee of the outcome of these appraisals. An external Board appraisal was conducted in 2019 by Leadership Edge. The appraisal found that the sitting Board possessed the necessary scientific and commercial knowledge and that the members provided a good basis for the Board's upcoming work.

Summary of Board Meetings During the Year

In 2019, the Board held 14 meetings, and one strategy day. During the year, the external auditors attended one meeting. Matters considered apart from scheduled items included continuous reviews of long-term strategies, review of new product alternatives, and the budget for 2020.

Board Composition and Independence

Pursuant to the company's Articles of Association, where elected by the AGM, the Board should consist of a minimum of three and a maximum of ten Directors and maximum of ten deputies. Otherwise, there is no stipulation in the Articles of Association regarding appointing or dismissing Directors. Pursuant to the Code, a majority of Directors elected by shareholders' meetings should be independent of the company and its management. At least two should also be independent of the company's major shareholders. Immunovia judges that its Board satisfies the requirements of independence.

At present, the company's Board of Directors consists of six members elected by shareholders' meetings.

Name Assignment
for the compa
ny and other
material
assignments
Elected to
the Board
Attendance
Board
meetings
Attendance
Remunera
tion
Committee
Attendance
Audit
Committee
Dependent
on the company
and management
Dependent
on major
shareholders
Carl Borrebaeck Chairman of the
Board
2007 14/14 3/3 - No No
Åsa Hedin Member 2015(Resi
gned 2019)
3/6 - 2/2 No No
Ann-Christine
Sundell
Member 2017 14/14 3/3 No No
Hans Johansson Member 2017 14/14 - 4/4 No No
Mimmi Ekberg Member 2018 14/14 - - No No
Christofer Sjögren Member 2018 12/14 - 2/2 No No

The Board's members and their independence are stated in the following table for calendar year 2019.

Board of Directors

Professor Carl Borrebaeck is a successful entrepreneur and founder of Immunovia, who also founded Senzagen AB (Publ.) (SENZA; Nasdaq First North), BioInvent International AB (Publ.) (BINV; Nasdaq Stockholm), and Alligator BioScience AB (Publ.) (ATORX; Nasdaq Stockholm). In 2009, he was awarded the AkzoNobel Science Prize and in 2012 he received the Royal Swedish Academy of Engineering's gold medal for his pioneering research on biomarkers, and in 2017 he was named Biotech Builder of the Year for his entrepreneurship. He is a life member of the IVA (Royal Swedish Academy of Engineering Sciences), a director of CREATE Health - the Strategic Division of Translational Cancer Research and former Deputy Vice-Chancellor of Lund University (responsible for its innovation systems and industrial partnerships) and Head of the Department of Immunotechnology. He is also the Founding Mentor for NOME (Nordic Mentor Network for Entrepreneurship).

Immunovia has signed an agreement with CB Ocean Capital AB regarding services to be performed by Carl Borrebaeck. He will provide the company with services focused on providing scientific and strategic support to the company, for example at scientific presentations and conferences. The services provided do not include tasks related to board assignments. Under the agreement, CB Ocean Capital AB will receive remuneration of SEK 31,500 per quarter, excluding additional social security contributions and value added tax, for work performed by Carl Borrebaeck for the company. The agreement runs from January 1, 2018 until further notice with three months of mutual notice.

Current assignments: Chairman of SenzaGen AB and CB Ocean Capital AB. Board member of Alligator Bioscience AB, Clinical Laserthermia Systems AB and Scandion A/S. Managing partner of Immunova Handelsbolag. Previous assignments (past five years): Chairman of LU Innovation System AB. Board member of Atlas Therapeutics AB, BioInvent International Aktiebolag, LU Holding AB, Medicon Village Fastighets AB and WntResearch AB. Deputy director of Endo Medical AB.

Holdings in the company as per Dec 31, 2019: 1,709,900 shares and 0 share warrants.

Ann-Christine Sundell holds an M.Sc. in biochemistry and has over 30 years' experience of global commercial positions in the diagnostics sector. She was EVP of Genetic Screening at PerkinElmer, one of the world's largest life science companies, for ten years, where she led one of the company's five strategic business areas with over 1,500 employees worldwide. She has rigorous strategic and operational experience in all segments significant to Immunovia Including Sales & Marketing, R&D, Production, Quality and regulatory issues.

Current assignments: Board member of Medix Biochemica Group Oy, Serres Oy, Biocartis NV, Raisio Oy and Revenio Group Oy. Delegation member of Raisio Oys research foundation and holder of Aconsult. Previous assignments (past five years): Chairman of Oy Medix Biochemica AB. Board member of Minervastiftelsen, Oy Medix Ab, Oy Medix Ab, Bueprint Genetics Oy, BluePrint Genetics Oy, Ledil Group Oy, Ledil Oy and Zymonostics ApS.

Holdings in the company as per Dec 31, 2019: 0 shares or share warrants.

Hans Johansson holds an M.Sc. (Eng.) in chemical engineering and has long-term experience and a broad-based contact network from previous roles in the life science and diagnostic industries, most recently as Vice President of Companion Diagnostics in Thermo Fisher's Specialty Diagnostics Group. Prior to that, his positions included serving as Global VP and Head of Marketing & Commercial Development for Thermo Fisher's ImmunoDiagnostics Division and VP of Pharmacia Biotechnology AB's Laboratory business area. He has also served as the President, Director and entrepreneur of various start-ups in the sector. He has over 30 years' experience of global business development and commercialization of biotech and diagnostic innovations.

Current assignments: Chairman of Doloradix AB och Myrtila AB. Board member of QLinea AB and Uppsala Innovation Centre AB.

Previous assignments (past five years): Deputy Director of Duvbo affärskonsult AB and Single Technologies AB. Holdings in the company as per Dec 31, 2019: 23,460 shares and 0 share warrants.

Christofer Sjögren has 15 years of experience from the finance industry as equity analyst at companies such as Carnegie, Danske Bank (Publ.) and Deutsche Bank (Publ.) based in Stockholm. He has also been an Investor Relations consultant at Citigate Stockholm (previously part of Huntsworth plc) and is Vice President of Trelleborg AB (Publ.) for eight years, and head of Trelleborg Investor Relations.

Current assignments: Vice President at Trelleborg AB (Publ.), as head of Trelleborg Investor Relations. Previous assignments (past five years): Boatd Member Trelleborg Group Treasury. Holdings in the company as per Dec 31, 2019: 37,332 shares and 0 share warrants.

Carl Borrebaeck (1948), Chairman

Ann-Christine Sundell (1964)

Hans Johansson (1954)

Christofer Sjögren (1966)

IMMUNOVIA AB (PUBL) Annual Report 2019 32

Mimmi Ekberg has about 30 years' experience from the pharmaceutical industry and 25 years' experience within oncology. She has had various positions at both national and Nordic level with experience of successfully launching specialist pharmaceutical. She has extensive strategic and operational experience in Sales & Marketing in the field of oncology. She has over 10 years' experience as business area manager from E. Merck, Amgen and today serves as business area manager at Oncology Nordic at Celgene, focusing on pancreatic cancer. She is a trained nurse with an academic background within medical oncology from Lund University, clinical trials at Karolinska University Hospital's oncology department and an Executive MBA from Stockholm University Current assignments: Business Unit Manager Oncology Nordics of Celgene AB. Previous assignments (past five years): Founder Board member of Anhörigfonden. Holdings in the company as per Dec 31, 2019: 0 shares or share warrants.

Mimmi Ekberg (1959)

Audit Committee

The Audit Committee members are Christofer Sjögren (Chairman) and Hans Johansson. The primary duty of the Committee is to assure the quality of financial reporting, which includes internal controls, reviews of material accounting and measurement issues, and reviews of the company's external reporting. Before the AGM, the Committee should also provide the Nomination Committee with proposals regarding audit fees. The Audit Committee also determines which other services apart from auditing the company may purchase from the company's auditors. The auditors meet the Board of Directors and Audit Committee each year, both with and without management in attendance.

Minutes are taken at all Audit Committee meetings and distributed to all Directors. The Committee also provides regular reports to the Board on its work through the Chairman of the Committee verbally reporting at the following Board meeting.

The Audit Committee monitors the company's internal controls through continuous feedback and maintains regular contact with the external auditors.

Business and control processes will be subject to further documentation and evaluation in 2019, through self-assessment and external appraisal.

The AGM 2019 resolved that the Chairman of the Audit Committee would receive a fee of SEK 40,000 and that other members should each receive SEK 20,000.

Remuneration Committee

Ann-Christine Sundell is Chairman of the Remuneration Committee, and Carl Borrebaeck is a member of the Remuneration Committee. Its primary duty is to consult on salary, other benefits and employment terms for the CEO and other senior executives, as well as incentive schemes for each group.

The Remuneration Committee should ensure compliance with the established guidelines for remunerating senior executives. Minutes are taken at all Remuneration Committee meetings and distributed to all Directors. The Committee also provides regular reports to the Board on its work through the Chairman of the Committee verbally reporting at the following Board meeting.

The AGM 2019 resolved that the Chairman of the Remuneration Committee would receive a fee of SEK 40,000 and that other members should each receive SEK 20,000.

Auditors

The AGM 2019 appointed Authorized Public Accountant Mats-Åke Andersson as Auditor in Charge with Authorized Public Accountant Martin Gustafsson as Deputy Auditor. In addition to auditing, the company has appointed Mazars Set Revisionsbyrå AB for guidance related to the audit on accounting issues. Information on remuneration to the auditing company is provided in Note 9.

CEO and management

The CEO was appointed by the Board and has the primary responsibility for the company's ongoing administration and daily operations. The segregation of duties between the Board and CEO is stated in the Rules of Procedure of the Board of Directors and instructions for the CEO. The CEO and group management are also responsible for preparing reports and compiling information for group management for Board meetings and present this material at Board meetings. The CEO is responsible for the company's financial reporting, and accordingly, should ensure that the Board gathers sufficient information to enable continuous evaluation the company's financial position. Accordingly, and jointly with the rest of group management, the CEO is responsible for compliance with the group's overall strategy, financial and business controls, capital structure, risk management and acquisitions. This includes preparing financial statements and communication with the capital markets.

In 2019, the CEO and six people in the management team made up group management. At the beginning of 2020, group management was increased by three people.

Management

Mats Grahn holds an M.Sc. (Eng.) in engineering physics from Lund University. He has over 25 years' experience of executive positions in the life science and diagnostic sectors, as well as extensive knowledge of business development, strategic development, marketing, product management, product development and accessing markets. He has headed up multinational and commercial operational organizations, restructured marketing organizations, integrated acquired companies and managed new start-ups. Much of his experience has been gathered from the leadership of multinational management teams and organizations in Scandinavia, Europe, the USA and Asia. Previous positions include: CVP of Marketing for Dako A/S, VP of Product Management for GE Healthcare, VP of Marketing for Amersham Biosciences, VP of Laboratory Separations for Pharmacia Biotech and VP of Prevas Bioinformatics.

Current assignments: Chairman and CEO of Gusmo AB. Deputy director of Utas Glassmakeri AB. Previous assignments (past five years): Chairman of Alligator Bioscience AB, Atlas Therapeutics AB and Bmatrix AB. Executive positions at Spiber Technologies AB and Biocrine AB Holdings in the company as per Dec 31, 2019: 365,039 shares and 21,500 share warrants.

Rolf Ehrnström holds an M.Sc. (Eng.) in biochemistry and biotechnology from the Royal Institute of Technology, Stockholm. He is the proprietor of Reomics AB and an Independent Partner of Ventac-Partners. He has long-term experience of managing research and has served as Chief Scientific Officer of Dako/Agilent and Gyros AB. He also has experience as Science Director of Amersham Bioscience and Pharmacia Biotech Current assignments: Board member of Reomics AB and Fluimedix A/S Danmark. Member of the Nomination

Committee of Idogen AB.

Previous assignments (past five years): Board member of Biomonitor A/S. Holdings in the company as per Dec 31, 2019: 50,750 shares and 4,000 share warrants.

Hans Liljenborg is a graduate of specialist education in business administration and mathematics from Lund University. He has long-term experience as a Finance Director of growing, global medical device companies. He has served as Finance Director of Physio Control Inc./Jolife AB and Finance Manager of Vivoline Medical AB, which was listed on Nasdaq First North in March 2015. He is also proprietor of his own accounting firm.

Current assignments: Board member of ADAYS AB. Deputy director of Entreprenörskompetens i Lund AB, and IES Interactive Executive Search AB. Auditor of the cooperative Byns Förskola Ekonomisk förening. Partner in Prosperus

Previous assignments (past five years): Executive positions at E-vård MinDoktor.se Sverige AB, Jolife AB, Quick-Cool AB and Vivoline Medical AB. Auditor of Bostadsrättsföreningen Långgårdsgatan 17 and Solbacka Trading. Holdings in the company as per Dec 31, 2019: 17,400 shares and 9,000 share warrants.

Laura Chirica holds an M.Sc. in biochemistry from Umeå University and a Ph.D. in biochemistry from Umeå University. With over 15 years' experience of business executive positions in the life science and diagnostics sectors, she brings extensive knowledge of business, organizational and strategic development, as well as sales, tactical marketing, product management and product support. She has led and restructured multinational sales and marketing organizations, managed business development, the integration of acquired companies, and developed brands and marketing communication platforms. Much of her experience has been gathered from leadership of multinational management teams and organizations in Scandinavia, Europe, the US and Asia. Previous positions include: VP of Sales and Marketing for Euro Diagnostica AB, Director of Purification Technologies for Europe Sartorius Stedim, Global Marketing Director of Dako A/S and Global Marketing Program Manager of GE Healthcare. Current assignments: Board member of SenzaGen AB.

Previous assignments (past five years): Executive position at Euro-Diagnostica AB. Holdings in the company as per Dec 31, 2019: 32,030 shares and 0 share warrants.

Henrik Winther holds a DVM and Ph.D. in cellular biology and histology from Copenhagen University. He has been at the leading edge of companion diagnostics for over ten years, and brings experience of research & development, business development, regulatory issues, production and commercialization of IVD products. From 2006, he was R&D manager of Dako A/S, as well as Design Manager of HercepTest CDx. He was then Head of Dako Business Development and was involved in the acquisition of Dako by Agilent Technologies. Previous positions include serving as Vice President and General Manager of Agilent Technologies in Santa Barbara, US, and Head of the R&D function of the Companion Diagnostics Division. He was previously an associate professor of cellular biology but has been focusing on cancer diagnostics for the past 17 years (finished at his own request at the end of the year)

Current assignments: Board member of Saga Diagnostics AB

Previous assignments (past five years): Executive positions at Agilent Technologies and Dako A/S. Holdings in the company as per Dec 31, 2019: 0 shares and 25,000 share warrants.

Mats Grahn, CEO

Rolf Ehrnström, Chief Scientific Officer

Hans Liljenborg, Chief Financial Officer

Laura Chirica, Chief Commercial Officer

Henrik Winther, SVP Business Development

IMMUNOVIA AB (PUBL) Annual Report 2019 34

Linda Mellby, VP Research & Development

Lotta Blomgren, Operations Director

Linda Mellby holds an M.Sc. in chemical engineering and a Ph.D. in immunotechnology from the Institution of Immunotechnology at Lund University. She has over ten years' experience of Immunovia's platforms, microarray technologies for recombinant antibodies and in-depth knowledge of the characteristics, technology development and clinical applications of the platform within oncoproteomics and autoimmunity. She has been one of the key researchers dealing with the development of Immunovia's microarray platform for disease proteomics, and has conducted extensive work on process optimization, standardization and clinical studies. Current assignments: None.

Previous assignments (past five years: None.

Holdings in the company as per Dec 31, 2019: 32,626 shares and 0 share warrants.

Lotta Blomgren holds a MSc in Chemical Engineering from Lund University, Sweden. Lotta has more than 30 years' experience within the life science and diagnostics industry, whereof 15 years in leading positions. She contributes with extensive experience from leading manufacturing, quality control and logistics teams, as well as managing transfer of new products from development to commercial scale. Her track record includes strategic reorganizations of international manufacturing networks, managing people and project portfolios, as well as due diligence of potential acquirement of new companies and Contract Manufacturing (CMO).

Previous positions include VP Technical Operations at Euro Diagnostica AB, Head of Supply Chain Bioglan AB, Director Product & Technology Support Ferring A/S, Head of Process Development Ferring AB, cross functional roles within Process Development and Project Management at Astra AB, Kabi Pharmacia AB and ACO AB. Current assignments: None.

Previous assignments (past five years): Executive positions at Bioglan AB och EuroDiagnostica AB. Holdings in the company as per Dec 31, 2019: 10,510 shares and 2,000 share warrants.

Additional Group Management from January 2020

Mike Pettigrew, Senior VP Sales North America, has a Bachelor of Science in biologi at Fairleigh Dickinson University. He brings over 30 years of experience and has focused his extensive global expertise in the management of marketing & sales, business and strategic account development, licensing, mergers & acquisition, and commercial technology platform development. While he was at Thermo Fisher Scientific, he managed large regional based sales teams (USA, Canada, Latin America, and South America) by providing sales, technical support, and customer support. Prior to Thermo Fisher Scientific, Michael was the Vice President of Corporate Development at Magellan Biosciences, where he was focused on M&A and licensing. Prior to that, Michael held positions at GE Healthcare (Vice President, Sales), Amersham (Vice President, Genomics), and Pharmacia (Director of Marketing, North America).

Current assignments: None.

Previous assignments (past five years): VP Sales Americas Thermo Fisher Scientific. Holdings in the company as per Dec 31, 2019: 0 shares and 52,000 share warrants.

Peter Schulz-Knappe, CTO, holds a doctorate in medicine and a doctorate in cell biology from Heidelberg University, Germany. He has been active in biotechnology and proteomics for over 25 years, as a serial contractor, primarily as CSO and CTO for biotechnology companies. His focus is research and development of diagnostic signatures from blood. He has developed several high capacity platforms for mass spectrometry-based peptide and protein analysis as well as protein arrays. He founded BioVisioN AG in Germany where he developed workflows for peptidomics, was CSO at Proteome Sciences in the UK (quantitative mass spectrometry) and CSO at Protagen in Germany (protein arrays for autoimmune diseases and immuno-oncology). He led several clinical trials with international research organizations and pharmaceutical companies to develop new diagnostics and companion diagnostics.

Current assignments: None.

Previous assignments (past five years): CSO, Protagen AG, Germany. Holdings in the company as per Dec 31, 2019: 0 shares or share warrants.

Hans Christian Pedersen, VP Business Development, holds a Master's Degree in Molecular Biology from the University of Copenhagen. He has over 18 years' experience in the sector working with drug development, antibody development, breast cancer research, complementary diagnostic development, IVD global marketing, scientific affairs and business development. He has extensive experience in both development and commercialization of diagnostic tests and has been involved in building and starting strategic partnerships with global pharma partners.

Current assignments: None

Previous assignments (past five years): Business Development Director, Unilabs; Director of Scientific Affairs, Agilent Technologies and Head of Companion Diagnostics and IHC reagents, Agilent Technologies. Holdings in the company as per Dec 31, 2019: 1,912 shares and 0 share warrants.

Annika Andersson, QA/RA Director, is a Biomedical Scientist from Malmö University. She has more than 25 years' experience within the life science and diagnostics industry, with the main focus on regulatory affairs and quality assurance of in vitro diagnostic medical devices. Annika contributes with global experience within regulatory strategies and regulatory submissions of IVDs. Her track record includes leading successful regulatory approval processes of medical devices for IVD CE marking as well as IVD approvals in Canada, China, India, Japan, Korea, Mexico, Russia and 510(k) clearances in USA.

Current assignments: None

Previous assignments (past five years): Leading position at Euro Diagnostica AB (now SVAR Life Science AB). Holdings in the company as per Dec 31, 2019: 2,800 shares and 3,000 share warrants.

Remuneration of Group Management

Total remuneration and other benefits granted directly or indirectly by the company to members of Group management are stated in note 10. The company has not issued any loans to members of group management.

Board of Directors' Proposed Guidelines for Remunerating Senior Executives

The AGM on April 26, 2019 adopted the following guidelines for remunerating senior executives:

Remuneration of senior executives of the company should consist of basic salary, potential variable compensation, other customary benefits and pensions. Total annual remuneration should be on market terms and competitive on the labor market where the executive is stationed, and consider individual qualifications and experience, as well as reflecting exceptional performance in overall compensation. Basic salary should be subject to annual review. Senior executives means the CEO and other members of the company's management.

Basic salary and variable compensation should relate to the executive's responsibilities and authority. Variable compensation should be payable in cash and/or in shares/share warrants/convertible instruments or other share-based instruments such as synthetic options or staff stock options and based on outcomes in relation to established targets and structured to promote shared interests between the executive and the company's shareholders. The vesting period or period from entering an agreement until a share may be acquired should not be less than three years. Variable cash compensation should not exceed basic salary. The terms and conditions governing variable compensation should be structured so that in especially severe financial conditions, the Board is able to limit or refrain from paying variable compensation if such payment is considered unreasonable and irreconcilable with the company's other responsibilities to shareholders. The annual bonus should have a capability for limitation or refraining from paying variable compensation if the Board considers that this is justified for other reasons.

If a Director renders services on behalf of the company in addition to service on the Board, consulting fees and other compensation for such work should be payable subsequent to a special decision by the Board.

As far as possible, pension benefits should be defined contribution. The CEO and other senior executives should have maximum notice periods of 18 months. Basic salary during the notice period and severance pay should not exceed an aggregate maximum amount corresponding to two years' basic salary.

The company's Board of Directors should endeavor for the Group's subsidiaries to apply these principles. The Board should be entitled to depart from the above guidelines if the Board considers that there are special reasons justifying this in an individual case. Questions regarding salary and other compensation to the CEO are subject to consultation by the Remuneration Committee and decided by the Board.

Internal Audit

The Group has straightforward legal and operational structure, and established governance and internal control systems. Against this background, the Board has decided not to create a dedicated internal audit. The Board's responsibility for internal control and governance is regulated by the Swedish Companies Act and the Swedish Annual Accounts Act, and the Code is also applied. Immunovia endeavors to manage its operations as effectively as possible. Financial reporting should be reliable and reflect the company's operations accurately and be prepared in accordance with applicable laws and ordinances. The Board determines which reports should be produced for the Board to be able to monitor the company's progress. Initially, the quality of financial reporting to the Board is evaluated by the Audit Committee.

Internal Controls and Control Environment

The Board of Directors' responsibility for internal controls is regulated by the Swedish Companies Act and the Swedish Annual Accounts Act, which stipulates that information on the most important elements of the company's systems for internal controls and risk management relating to financial reporting should be included in the Corporate Governance Report, as well as the Code. The Board's duties include ensuring that the company has good internal controls and formal procedures that ensure compliance with established principles for financial reporting and internal controls, and that expedient systems for monitoring and controlling the company's operations and the risks the company and its operations are associated with, are in place. Decision-paths, authorizations and responsibilities being clearly defined and communicated between different levels of the organization, as well as control documentation such as policies and guidelines covering all material segments, and providing guidance to different executives within the group, is an important component of the control environment.

One significant part of the Board's work is to formulate and approve a number of fundamental policies, guidelines and frameworks. These include the Board's Rules of Procedure, the Instructions for the CEO, Corporate Communication and Finance Policies. The purposes of these policies include providing a foundation for good internal controls. All policies are subject to annual review and approval by management or the Board. Additionally, the Board should endeavor for its organizational culture to provide clearly defined roles, responsibilities and processes that favor efficient management of the operation's risks and enable targets to be achieved.

The overall purpose of internal controls is to ensure that the company is following up on its operational strategies and goals, and its owners' investments are protected. Additionally, internal controls should ensure that there is reasonable assurance that financial reporting is reliable and prepared consistently with generally accepted accounting practice, compliant with applicable laws and ordinances and the standards applying to listed companies.

Financial Reporting

The Board bears overall responsibility for internal controls over financial reporting. With the aim of creating and maintaining a functional control environment, the Board has adopted a number of policies and control documents that regulate financial reporting. They mainly consist of the Board's Rules of Procedure, Instructions for the CEO and instructions for financial reporting. The Board has also adopted a dedicated approvals list and Finance Policy. The company has an accounting handbook stating the principles, guidelines and process definitions for accounting and financial reporting. Additionally, the Board has established an Audit Committee whose primary duty is to ensure compliance with established principles for financial reporting and internal controls, and for maintaining regular contact with the company's auditors. Responsibility for maintaining an effective control environment and ongoing work on internal controls over financial reporting has been delegated to the company's CEO. The CEO provides regular reports to the Board pursuant to the established instructions for the CEO, and instructions for financial reporting. The Board also receives reports from the company's auditor. Based on a control environment perceived as effective and external examination by auditors, the Board judges that there are no special circumstances in the operation, or other conditions, that would justify establishing an internal audit function

Risk Assessment

Risk assessment includes identifying risks that may arise if the fundamental standards apply to the company's financial reporting are not satisfied. The company's management has identified and evaluated the risks that are relevant to the company's operations and evaluated how these risks can be managed in a dedicated risk assessment document. Within the Board, the Audit Committee bears primary responsibility for continuously evaluating the company's risk situation, with the Board subsequently conducting an annual review of the risk situation.

Control Activities

Control activities limit identified risks and ensure accurate and reliable financial reporting. The Board is responsible for internal controls and monitoring management. This is conducted through internal and external control activities, and by examining and following up on the company's control documents related to risk management.

Information and Communication

The company has information and communication pathways intended to promote the accuracy of financial reporting and enable reporting and feedback from operations to the Board and management, through means including making control documents in the form of internal policies, guidelines and instructions for financial reporting available and familiar to the affected staff. The Board has also adopted a Corporate Communication Policy that formalizes the company's communication through financial information in the form of interim reports, financial statements, annual accounts and press releases in tandem with significant events that may be share price sensitive. Corporate communication complies with the standards stated in Nasdaq Stockholm's Rulebook for Issuers. The Board reviews external financial reports prior to publication. The Corporate Communication Policy also stipulates how communication can be affected, and which parties may represent the company. Information distributed through press releases is also available on the company's website, as is other information considered valuable.

Monitoring

The compliance with, and effectiveness of, internal controls are subject to regular monitoring. The CEO ensures that the Board receives regular reports on the progress of the company's operations, including the process of the company's results of operations and financial position, and information on important events, such as research outcomes and important agreements. The CEO also reports these issues at each Board meeting.

The Auditor's Examination of the Corporate Governance Statement

To the general meeting of shareholders of Immunovia AB (Publ.), corporate ID no. 556730-4299

Assignment and Segregation of Duties

The Board of Directors is responsible for that the corporate governance statement for 2019 on pages 26-37 has been prepared in accordance with the Annual Accounts Act.

Orientation and Scope of Review

My examination of the corporate governance statement is conducted in accordance with FAR's auditing standard RevU 16 The auditor's examination of the corporate governance statement. This means that my examination of the corporate governance statement is different and substantially less in scope than an audit conducted in accordance with International Standards on Auditing and generally accepted auditing standards in Sweden. I believe that the examination has provided us with sufficient basis for my opinions.

Opinion

A corporate governance statement has been prepared. It is consistent with the annual accounts and the consolidated accounts and is in accordance with the Annual Accounts Act.

Lund, March 20, 2020

Mats-Åke Andersson Authorized public accountant

Statutory Administration Report

The Board of Directors and CEO of Immunovia AB (Publ), corporate identity number 556730- 4299, hereby submit the annual accounts and consolidated accounts for the financial year 2019. Unless otherwise stated, the information relates to the Group. Information in parentheses refers to the previous year. Amounts are stated in SEK (SEK thousands) unless otherwise stated. Rounding up differences may occur. During the period, the Parent Company's operations essentially coincide with the Group's. The comments on the Group's progress therefore also apply to the Parent Company.

Operations

Immunovia AB conducts the development of new and improved methods for diagnosing complex diseases in cancer and autoimmunity. Operations are mainly conducted in the parent company Immunovia AB, and accordingly, the following comments apply to the Group and parent company.

Progress of Operations and Significant Events in the Financial year

Successful results from the Optimization Study reported in Q2 as well as the Commercial Test Model study which was completed during Q4 pave the way for sales start in Q3 2020. The study was designed to complete the commercial biomarker signature of IMMray™ PanCan-d and confirm the future product's accuracy in differentiating stages I to IV of pancreatic cancer (PDAC) against control groups that best reflect the clinical, commercial situation, i.e. patients with non-specific but worrying symptoms, including type II diabetes, as well as healthy individuals.

IMMray™ PanCan-d in combination with the tumor marker CA 19-9 was able to separate the PDAC samples in stages I to IV from all control groups with 96 percent accuracy. Furthermore, the accuracy was 95 percent in excluding PDAC in early stages I and II, confirming that Immunovia's test in combination with CA 19-9 allows the early detection of pancreatic cancer through a simple blood test.

Intensified Launch Preparations

With two milestones left - a verification study and a final validation study - before the commercialization of the IMMray™ technology during Q3 2020, we are now intensifying the final preparations for the launch. We have been successful in establishing a network of world-renowned Key Opinion Leaders (KOL) and healthcare specialists who have collaborated with us not only on how the test should be used in practical clinical work, but also to provide us with the necessary blood samples taken in real clinical environments to test our IMMray™ technology. Our team in the US and the lab in Marlborough, MA are working hard to implement logistics and distribution systems that provide fast test results to support all of our customers in the US. We have established a scalable sales and marketing organization that caters to our leading clinical clients at gastroenterology centers around the US. Collaboration with various patient organizations has also been a focus area for us, as they play an important role in creating awareness of the disease and supporting patients and their families

Programs With Clinical Prospective Studies Continue As Planned

To validate the clinical benefit of IMMray™ PanCan-d, which is important for reimbursement, Immunovia continued with the three major prospective studies in 2019 covering the three main pancreatic cancer risk groups. These three clinical studies, the largest studies in the world for these three risk groups, include 24 cancer centers in the US and Europe and over 10,000 people.

Development Projects At An Early Stage

In addition to our main focus of pancreatic cancer, Immunova conducts early projects in other cancers and autoimmune diseases. These are in the earlier stage of development, the "Discovery Study", where we establish KOL collaboration to gain access to expertise about the clinical need and high-quality blood samples with clinical information representing this. These collaborations are the most important key activity for success in the studies that are crucial to the decisions to invest in the development phase, "Development Studies", which leads to a product and is a significantly greater financial commitment than the Discovery studies.

New Share Issue

During the year, a new share issue was carried out through 123,500 warrants being exercised, which brought in a total of SEK 10.2 million. Through the new issue, the number of shares and votes increased by 123,500 and amounted to 19,654,853 shares/votes at the end of the period.

Risks and Uncertainty Factors

Operational Risks

Immunovia's operations and market are subject to a number of risks that are wholly or partly outside the company's control, and effect, or may affect, Immunovia's operations, financial position and results of operations. The following risk factors have been reviewed without any internal order of priority, and without any claim as to completeness:

• Immunovia is a development enterprise with a fairly short operational history, which means there may be a delay before the company is able to report sales revenues.

• The company is in a commercialization phase, which involves risks that sales revenues are lower than expected, or do not appear at all.

• Validation studies may generate unforeseen or negative research outcomes.

• Development expenses are difficult to estimate in advance. These expenses may be higher than planned.

• The company is dependent on collaborative and license agreements, and there is a risk that the company is unable to enter collaborations.

• There is a risk that Immunovia does not obtain the registrations necessary to sell and market its products.

  • There is a risk that the company does not obtain accreditation pursuant to ISO 17025.
  • Immunovia is subject to several government regulations that may be reformed.

• There is a risk that Immunovia is unable to defend granted patents, registered brands and other intellectual property, or registration applications filed are not granted.

Financial Risks

For a review of the financial risks, please refer to note 3.

Human Resources

The Group had an average of 48 (39) employees in the period, and at the end of the period, there were 49 (45) employees.

Incentive Schemes

Detailed information on the company's outstanding share warrant programs is in note 10 below.

Sustainability and Environment

Immunovia does not conduct any operations that are hazardous to the environment that require Permits or notification pursuant to the Swedish Environmental Code. Please refer to the Sustainability Report on pages 19-25.

Dividend

The Board of Directors is proposing that no dividend is paid for the financial year 2019

Significant Events Since 2019 And Comments From The CEO

I want to take this opportunity to discuss significant events that have occurred since the close of 2019, both at Immunovia and in the world. In light of these extraordinary times and COVID-19, I want to reassure everyone that Immunovia remains on-track to launch the very first test for early diagnosis of pancreatic cancer, IMMray™ PanCan-d, in the US market during Q3 2020. Any effects by the global pandemic on our business and the launch plans have, thus far, been mitigated and/ or adapted to accommodate the associated challenges and currently create no impact on the Q3 launch.

Additionally, Immunovia has had some additional events following the close of 2019 which include:

• The building up of the Company's management team with a new Senior Vice President of Sales NA (North America), Michael Pettigrew. Michael brings with him a very successful track record in product launches and sales growth, couple with a unique set of leadership skills. Michael is a great addition to Immunovia.

• A visit from the Crown Princess of Sweden and Prince Daniel who came to Immunovia at the end of January. The delegation included the Governor of Skåne County, Anneli Hultén and additional representatives from Skåne County Administrative Board and the Royal Court. We are grateful to The Crown Princess of Sweden and Prince Daniel for their interest in our company and in IMMray™ – state-of-the-art technology as part of their engagement to promote Swedish innovations.

With two milestones remaining – a Verification study and a final Validation study – before the commercialization of IMMray™ PanCan–d during Q3 2020, we are intensifying the final launch preparations. We have successfully established a network of world-renowned Key Opinion Leaders and healthcare specialists, who have collaborated with us on how the test should be used in practice. Our production facility is ready with ample capacity and the company's well-established infrastructure is fully prepared for the final accreditations.

I am confident that, with our great team assembled under the Immunovia name, we will do our utmost to adjust to any further unforeseen circumstances and will continue our commercialization efforts to ensure a successful launch of IMMray™ PanCan–d. Immunovia is targeting an initial addressable market of USD 4.4 billion in the US and Europe, and we look forward to working with healthcare providers around the world to improve the situation of this affected patient group.

Outlook for 2020

With two milestones left - a verification study and a final validation study - before the commercialization of IMMray™ PanCan-d during the Q3 2020, we are now stepping up the final preparations for the launch. We have successfully established a network of world-renowned Key Opinion Leaders and healthcare specialists who have worked with us on how the test should be used in practice. They have also provided us with the necessary blood samples, best reflecting the clinical setting, so that we have been able to test our IMMray ™ technology. Our team in the US and at the laboratory in Marlborough, are working intensively to implement a logistics and distribution system that provides fast test results to all our customers in the US. We have established a scalable sales and marketing organization that we will be expanding in 2020 so that we can reach the top doctors at gastro-centers around the US. Collaboration with various patient organizations has also been a focus for us, as it plays an important role in increasing awareness of the disease and supporting patients and their families. These collaborations will be expanded in 2020.

Group financial summary

2019 2018 2017 2016
Full Year Full Year Full Year Full Year
Net sales (SEK 000)
Earnings/loss after financial items (SEK 000)
Total assets (SEK 000)
Equity ratio (%)
356
-114,517
419,366
85
333
-86,531
477,383
97
149
-45,232
250,770
94
177
-14,723
283,409
98

Parent company financial summary

2019 2018 2017 2016
Full year Full year Full year Full year
Net sales (SEK 000) 356 333 149 177
Earnings/loss after financial items (SEK 000) -90,868 -66,334 -45,232 -14,723
Total assets (SEK 000) 425,363 497,951 250,665 283,409
Equity ratio (%) 95 97 94 98

335,905,705

Proposed appropriation of the Company's Earnings

The following funds are at the disposal of the Annual General Meeting (SEK):

Share premium reserve 10,231,975
Profit brought forward 416,204,494
Earnings/loss for the year -90,530,764
335,905,705
The Board proposes that:
Carried forward 335,905,705

EARLY DETECTION

Financial Statements

Financial Statements 42
Group Key Indicators 43
Consolidated Income Statement 44
Consolidated Statement of Comprehensive Income 44
Comments on the Income Statement 44
Consolidated Balance Sheet 45
Comments on the Balance Sheet 46
Consolidated Statement of Changes in Equity 46
Consolidated Cash Flow Statement 47
Comments on the Cash Flow Statement 47
Parent Company Income Statement 48
Parent Company Statement of Comprehensive Income 48
Parent Company Balance Sheet 49
Parent Company Statement of Changes in Equity 50
Parent Company Cash Flow Statement 51
Notes 52
Board of Directors' and Chief Executive Officer's
certification 71
Audit Report 72
Definitions 76
Glossary77
Shareholder information 79

Group Key Indicators

2019 2018 2017 2016
SEK 000 unless otherwise stated Full year Full year Full year Full year
Operating earnings/loss -114,248 -87,709 -45,520 -14,978
Earnings/loss for the period -114,521 -86,539 -45,232 -14,723
Earnings per share before dilution (SEK) -5.85 -4.67 -2.67 -0.98
Earnings per share after dilution (SEK) -5.85 -4.67 -2.67 -0.98
R&D expenses -34,273 -26,048 -24,041 -24,239
R&D expenses as a percentage of operating expenses
(%) 26 23 34 62
Cash and cash equivalents at end of the period 263,345 386,136 192,426 259,094
Cash flow from operating activities -91,952 -84,111 -46,318 -11,867
Cash flow for the period -122,797 193,679 -66,661 183,327
Equity 357,604 461,952 236,795 276,631
Equity per share (SEK) 18.19 23.65 13.67 16.46
Equity ratio (%) 85 97 94 98
Average number of employees 48 39 30 16
Average number of employees in R&D 19 17 16 11

The Group was created in 2015 with the formation of the subsidiary Immunovia Inc. In 2018, a subsidiary was established in Germany, Immunovia GmbH and in 2019 Immunovia Incentive AB was started. The business is mainly conducted in the Parent Company, which is why the Group's key figures essentially reflect the parent company's key figures.

Alternative Key Indicators

Of the above key indicators, only the basic and diluted earnings per share metric is obligatory and defined pursuant to IFRS. Of the other key indicators, earnings/loss for the year, cash and cash equivalents at the end of the period, cash flow from operating activities, cash flow for the period and equity are from an IFRS-defined accounting presentation

The following table indicates the computation of key indicators partly for the IFRS mandatory key indicator basic and diluted earnings per share, but also the key indicators R&D expenses, R&D expenses as a percentage of operating expenses, equity per share and equity ratio.

The company's business is to conduct research and development(R&D), which is why R&D costs as a percentage of operating expenses, excluding impairment losses, are a key indicator as a measure of efficiency and how much of the costs in the company are used in R&D. The company's operations are such that it does not have an even flow of revenue, but this comes irregularly in connection with the signing of license agreements and milestones achieved. Therefore,

the company complies with the key indicators of equity/ assets and equity per share attributable to the parent company's shareholders to be able to assess the company's financial position and stability.

Along with these key figures, the various measures of cash flow that follow from the consolidated cash flow report are also followed.

For definitions, see the Definitions section below.

2019 2018 2017 2016
SEK 000 unless otherwise stated Full year Full year Full year Full year
Earnings/loss for the year
Average number of shares before and after
-114,521 -86,539 -45,232 -14,723
dilution 19,569,089 18,545,795 16,932,559 14,985,688
Earnings per share before dilution (SEK) -5.85 -4.67 -2.67 -0.98
Operating expenses -141,343 -113,838 -69,768 -39,481
Administrative and sales expenses -98,623 -85,012 -44,463 -14,639
Depreciation and amortization -8,447 -2,777 -1,264 -549
R&D expenses -34,273 -26,048 -24,041 -24,293
R&D expenses as a percentage of operating
expenses (%)
26 23 34 62
Equity 357,604 461,952 236,795 276,631
Registered number of shares on the balance
sheet date 19,654,853 19,531,353 17,318,059 16,804,059
Equity per share 18.19 23.65 13.67 16.46
Equity 357,604 461,952 236,795 276,631
Total assets 419,366 477,383 250,770 283,409
Equity ratio (%) 85 97 94 98

Consolidated Income Statement

Comments on the income statement

Operating Income

Net sales for 2019 amounted to SEK 356,000 (333). Sales consist mainly of royalty income.

Operating Expenses and Earnings/Loss

Earnings/loss for the year was SEK –114.5 million (–86.5). The net loss for 2019 is greater due to intensified marketing efforts ahead of the upcoming launch and that the company's prospective studies are entering a more cost-intensive phase.

Other external expenses and personnel expenses rose in total by SEK 22.3 million compared with last year and amounted to SEK 132.9 million (110.5) in 2019.

Research and Development

Total R&D costs for 2019 amounted to SEK 34.2 million (26.0), which corresponds to 26% (23%) of the Group's total operating expenses.

2019 2018
SEK 000 Note Full Year Full Year
Operating income etc
Net sales 5 356 333
Other operating income 7 458 744
Total 814 1,077
Operating expenses
Other external expenses 8,9 -78,320 -65,275
Personnel expenses 10 -54,576 -45,258
Capitalized work for own account 26,716 25,052
Depreciation/amortization of tangible/intangible fixed assets 8 -8,447 -2,777
Other operating expenses -435 -528
Total operating expenses -115,062 -88,786
Operating earnings/loss -114,248 -87,709
Profit/loss from financial items
Financial income 11 3,820 1,178
Financial expenses 8,12 -4,089 -1
Total financial items -269 1,177
Earnings/loss after financial items -114,517 -86,532
Tax on earnings for the year 13 -4 -7
Earnings/loss for the year -114,521 -86,539
Earnings per share (SEK) -5.85 -4.67
Average number of shares 19,569,089 18,545,795
Number of shares at period's end 19,654,853 19,531,353

Consolidated Statement of Comprehensive Income

2019 2018
SEK 000 Full Year Full Year
Earnings/loss for the period -114,521 -86,539
Items that may be reclassified later in the income statement
Exchange rate differences for foreign net investment -409 -593
Other earnings/loss for the year -409 -593
Comprehensive income for the year -114,930 -87,132

Consolidated Balance Sheet

2019 2018
SEK 000
Note
Dec 31 Dec 31
ASSETS
Fixed assets
Intangible assets
Capitalized development expenditure
14
71,213 44,788
Patents, licenses and similar rights
15
20,646 16,998
91,859 61,786
Tangible assets
Improvements on someone else's property
16
5,760 3,304
Equipment, tools, fixtures and fittings
17
10,879 10,715
Right-of-use leasing
18
38,585 0
55,224 14,019
Financial assets
Other non-current receivables
19
3,125 3,008
Total assets 150,208 78,814
Current assets
Current receivables
Accounts receivable 0 32
Other receivables 3,278 8,473
Prepaid expenses and deferred income
20
2,535 3,928
5,813 12,433
Cash and cash equivalents 263,345 386,136
Total current assets 269,158 398,569
TOTAL ASSETS 419,366 477,383
EQUITY AND LIABILITIES
22
Equity
Share capital 983 977
Other paid-up capital 636,924 626,348
Reserves -1,002 -593
Accumulated earnings or loss incl. earnings/loss for the year -279,300 -164,779
Total equity 357,604 461,952
Long-term liabilities
Leasing liabilities
25
33,121 0
Total long-term liabilities 33,121 0
Current liabilities
Leasing liabilities
25
Accounts payable
4,596
5,426
0
3,031
Other liabilities 1,920 1,121
Accrued expenses and deferred income
23
16,350 11,279
Total current liabilities 28,641 15,431
TOTAL EQUITY AND LIABILITIES 419,366 477,383

Comments on the Balance Sheet

Investment

Purchases of intangible assets totaled SEK 30.6 million (28.2), divided between capitalized expenditure for development SEK 26.7 million (25.0), patents SEK 3.8 million (2.3) and other tangible assets of SEK 0 (0.89). Capitalized expenditure for development was partly funded with decided and paid subsidies, less the carrying amount of the corresponding amounts. Of the year's investment in capitalized expenditure for development SEK 291,000 (2,8 m) was covered by subsidies.

During the year, tangible fixed assets were acquired in the form of equipment and improvement expenses on another property for SEK 6.0 million corresponding to SEK 9.0 million in the same period last year.

No investments in financial assets were made in 2019.

Equity

Equity at the end of the period amounted to SEK 357.6 million (461.9) and the equity ratio was 85% (97%). During the year, a new issue of 123,500 shares was carried out, which brought the company in a net SEK 10.2 million.

Consolidated Statement of Changes in Equity

Accumulated
Earnings or Loss
incl. earning/loss
SEK 000 Share
Capital
Reserves for the year Total Equity
Opening balance January 1,
2018
866 0 -78,241 236,795
Comprehensive income for the
year
-86,539 -86,539
Transactions with shareholders in
their capacity as owners
Deposited share warrant
premiums
936
New share issue 111 326,038
Share issue costs -14,685
Translation difference -593 -593
Closing balance December 31,
2018
977 -593 -164,780 461,952
Comprehensive income for the
year
-114,521 -114,521
Transactions with shareholders in
their capacity as owners
Deposited share warrant
premiums
344
New share issue 6 10,238
Translation difference -409 -409
Closing balance December 31,
2019
983 -1,002 -279,301 357,604

Consolidated Cash Flow Statement

2019 2018
SEK 000
Note
Full Year Full Year
Operating activities
Operating earnings -114,249 -87,709
Adjusted for non-cash flow items 24 8,444 2,682
Interest received 285 319
Interest paid -1,316 -1
Tax paid -4 -7
Cash flow from operating activities before
changes in working capital -106,840 -84,716
Cash flow from changes in working capital
Changes in operating receivables 6,621 -840
Change in operating liabilities 8,267 1,445
Cash flow from operating activities -91,952 -84,111
Investment activities
Investment in intangible assets -30,568 -28,230
Investment in tangible assets -6,034 -9,056
Investment in financial assets 0 -2
Cash flow from investment activities -36,602 -37,288
Financing activities
Amortization of leasing liability 25 -5,115 0
National and European subsidies of developme
nt expenses 291 2 791
New share issue 10,238 311,352
Deposited share warrant premiums 344 936
Cash flow from financing activities 5,758 315,079
Cash flow for the year -122,797 193,680
Cash and cash equivalents at beginning of year 386,136 192,425
Exchange rate differences in cash and cash
equivalents 6 31
Cash and cash equivalents at end of year 26 263,345 386,136

Comments on the Cash Flow Statement

Cash flow from operating activities for 2019 amounted to SEK -92.0 million (-84.1) and the total cash flow amounted to SEK -122.8 million (193.7).

Cash and Cash Equivalents

Cash and cash equivalents on December 31, 2019 amounted to SEK 263.3 million (386.1). Company management judges that there is enough working capital to cover working capital requirements for about 1.5 years ahead, given the current business and development plan.

2019 2018
SEK000 Note Full Year Full Year
Operating revenue etc 6
Net sales 5 356 333
Capitalized work for own account 26,716 25,052
Other operating revenue 7 458 744
Total operating revenue 27,530 26,129
Operating expenses 6
Other external expenses 8,9 -79,046 -59,679
Personnel expenses 10 -38,326 -32,003
Depreciation/amortization of tangible/intangible fixed assets -2,950 -1,996
Other operating expenses -335 -527
Total operating expenses -120,657 -94,205
Operating earnings/loss -93,128 -68,076
Profit/loss from financial items
Financial income 11 4 ,981 1,743
Financial expense 12 -2,721 -1
Total financial items 2,260 1,742
Appropriations
Group contribution received 337 0
Total appropriations 337 0
Earnings/loss before tax -90,531 -66,334
Tax on earnings for the year 13 0 0
Earnings/loss for the year -90,531 -66,334

Parent Company's Income Statement

Parent Company's Statement of Comprehensive Income

2019 2018
SEK000 full year full year
Earnings/loss for the year -90,531 -66,334
Other comprehensive income
Other comprehensive income for the year 0 0
Total comprehensive income for the year -90,531 -66,334

Parent Company's Balance Sheet

SEK 000
Note
2019
Dec 31
2018
Dec 31
ASSETS
Fixed assets
Intangible assets
Capitalized development expenditure
14
71,213 44,788
Patents, licenses and similar rights
15
19,693 16,080
90,906 60,868
Tangible assets
Improvements on someone else's property
16
4,782 2,300
Equipment, tools, fixtures and fittings
17
7,475 6,689
12,257 8,989
Financial assets
Participations in group companies
21 303
103,466
253
40,110
Total assets
Current assets
Current receivables
Accounts receivable 0 32
Receivables from group companies 53,579 29,984
Other receivables 3,255 8,465
Prepaid expenses and deferred income
20
3,416 3,843
Cash and bank balances 261,647 385,517
Total current assets 321,897 427,841
TOTAL ASSETS 423,363 497,951
EQUITY AND LIABILITIES
Equity
22
Restricted equity
Share capital 983 977
Fund for development expenditure 65,569 39,143
66,552 40,120
Non-restricted equity
Share premium reserve 10,232 312,178
Accumulated earnings/loss 416,204 196,786
Earnings/loss for the year -90,531 -66,334
335,905 442,630
Total equity 402,457 482,750
Current liabilities
Accounts payable
Other liabilities
5,022
1,913
3,007
1,121
Accrued expenses and deferred income
23
Total current liabilities
15,971
22,906
11,074
15,202

Parent Company's Statement of Changes in Equity

Share Fund for
develop
ment
Share
premium
Accumula
ted
earnings
Ear
nings/
loss
for the
SEK 000 capital expenditure reserve or loss year Total equity
Opening balance, January 1, 2018 866 16,883 4,897 259,382 -45,232 236,795
Transfer of previous year's earnings/
loss
-4,897 -40,335 45,232 0
Comprehensive income for the year -66,334 -66,334
Capitalized development expenditu
re for the year
22,261 -22,261
Transactions with shareholders in
their capacity as owners
Deposited share warrant premiums 936 936
New share issue 111 325,927 326,038
Share issue costs -14,685 -14,685
Closing balance December 31, 2018 977 39,144 312,177 196,786 -66,334 482,750
Opening balance January 1, 2019 977 39,144 312,177 196,786 -66,334 482,750
Transfer of previous year's earnings/
loss
-312,177 245,843 66,334 0
Comprehensive income for the year -90,531 -90,531
Capitalized development expenditu
re for the year
26,425 -26,425 0
Transactions with shareholders in
their capacity as owner
New share issue 6 10,232 10,238
Closing balance December 31, 2019 983 65,569 10,232 416,204 -90,531 402,457

Parent Company's Cash Flow Statement

2019 2018
SEK 000 Note Full year Full year
Operating activities
Operating earnings/loss -93,128 -68,076
Adjustments for non-cash flow items 24 2,950 2,230
Interest received 270 306
Interest paid -2 -1
Tax paid 0 0
Cash flow from operating activities before changes
in working capital
-89,910 -65,541
Cash flow from changes in working capital
Changes in operating receivables -15,933 -23,826
Changes in operating liabilities 8,042 1,332
Cash flow from operating activities -97,801 -88,035
Investment activities
Investment in intangible assets -30,568 -27,341
Investment in tangible assets -5,980 -6,149
Investment in financial assets -50 -253
Cash flow from investment activities -36,598 -33,743
Financing activities
National and European subsidies of development
expenses 291 2,791
New share issue 10,238 311,352
Share warrant premiums deposited 0 936
Cash flow from financing activities 10,529 315,079
Cash flow for the year -123,870 193,301
Cash and cash equivalents at beginning of year 385,517 192,216
Cash and cash equivalents at end of year 26 261,647 385,517

Additional Information

NOTE 1 GENERAL INFORMATION

Immunovia AB (Publ.), with its registered office in Lund, registered in Sweden with corporate identity number 556730-4299, is the parent company of the wholly-owned subsidiaries Immunovia Incentiva AB with its registered office in Lund, corporate identity number 559198- 2870, Immunovia Inc., file number 350589-6, with its registered office in Wilmington, US and Immunovia GmbH corporate identity number HRB 111 597, with its registered office in Frankfurt am Main.

These companies are collectively termed the group, or Immunovia. The address is Medicon Village, 223 81 Lund, Sweden. The group was formed in December 2015 through the incorporation of Immunovia Inc. The Group's operations consist of the development of new and improved methods for diagnosing complex diseases within cancer and autoimmunity. The Board of Directors approved these Consolidated Accounts for publication on March 20, 2020.

NOTE 2 ACCOUNTING POLICIES

The Consolidated Accounts have been prepared in accordance with the Swedish Annual Accounts Act, RFR 1 Supplementary Accounting Rules for Groups, International Financial Reporting Standards (IFRS) and interpretation statements from the IFRS Interpretations Committee (IFRS IC) as endorsed by the EU.

The parent company's Annual Accounts have been prepared in accordance with the Swedish Annual Accounts Act and RFR 2 Accounting for Legal Entities. This recommendation means that the parent company applies the same accounting policies as a group, apart from in those cases where the Swedish Annual Accounts Act or applicable tax regulation limit the scope to apply IFRS. Differences between the parent company's and group's accounting policies are stated under the parent company's accounting policies below.

Basis of Preparation

The Consolidated Accounts have been prepared in accordance with the cost method. The Balance Sheet items entitled current assets and current liabilities are expected to be recovered and paid within 12 months. All other Balance Sheet items are expected to be recovered or paid later. The Group's functional reporting currency is Swedish kronor. The consolidated accounts and annual report are presented in thousands of Swedish kronor (SEK 000) unless otherwise stated.

New and Revised Standards Applied By the Group

IFRS 16 Leases came into effect from January 1, 2019. The Group has applied the simplified transition method, which means that comparative information in previous periods has not been recalculated. The leasing liability consists of the discounted remaining lease payments as at January 1, 2019. The right-of-use asset for all agreements corresponds to the lease liability adjusted for prepaid or accrued lease fees reported in the balance sheet as at January 1, 2019. The transition to IFRS 16 has had no effect on equity.

The Group applies the relief rules regarding leasing agreements where the underlying asset has a low value and short-term leasing agreements, which also include agreements that will be concluded in 2019. The most significant leasing agreements consist of agreements relating to the lease of office premises. As a result of the introduction of IFRS 16, the Group's Total Assets have increased through the inclusion of right-of-use assets and leasing liabilities. Leasing fees, which in the comparative year, according to IAS 17, have been reported as other external expenses in the income statement, have been replaced by depreciation of the right-of-use assets, which are recognized as an expense in the income statement and interest on the leasing liability, which is reported as a financial expense. The leasing payment is divided between amortization of the leasing liability and payment of interest.

The transition to IFRS 16 has also had effects on the cash flow statement. Compared to 2018, the cash flow from operating activities is positively affected by the depreciation of the right-ofuse assets as non-cash flow, while parts of the lease payments are reported as amortization of interest-bearing liabilities in the cash flow from financing activities. The second part of the leasing payments is reported as interest paid in the cash flow from operating activities.

For more information about leasing agreements and transitional effects, see Note 8.

New Standards and Interpretations That Have Not Yet Been Applied By The Group

A number of new standards and interpretations come into force for fiscal years beginning after January 1, 2019 and have not been applied in the preparation of this annual report. The new standards and interpretations that have not yet come into force are not expected to have any impact on the Group's financial reports

Consolidated Accounts

Subsidiaries are all companies over which the Group exerts a controlling influence. The Group controls a company when it is exposed, or has rights, to variable returns from its holding in the company, and has the possibility to affect returns through its influence in the company. Subsidiaries are included in the Consolidated Accounts effective the date when controlling influence is transferred to the group. They are derecognized from the Consolidated Accounts effective the date the controlling influence ceases.

The Acquisition method is used for recognizing the Group's business combinations. The purchase price for the acquisition of a subsidiary consists of the fair value of the assets acquired and liabilities the group takes over from previous owners of the acquired company, and the shares issued by the Group. The purchase consideration also includes the fair value of all assets or liabilities that are a consequence of an agreement on a conditional purchase consideration. Identifiable acquired assets and liabilities taken over in a business combination are initially measured at fair value on the acquisition date. Acquisition-related costs are expensed as they arise.Intra-group transactions, Balance Sheet items and unrealized gains and losses on transactions between Group companies are eliminated. The accounting policies for subsidiaries have been amended were applicable to ensure consistent application of the group's policies

Translation of Foreign Currency

Functional currency and presentation currency

Items recognized in the financial statements for the different entities of the Group are measured in the currency used in the economic environment where each entity is mainly operational (functional currency). In the Consolidated Accounts, Swedish krona (SEK) is utilized, which is the Group's presentation currency.

Transactions and balance sheet items

Foreign currency transactions are translated into the functional currency at the exchange rates prevailing on the transaction date or the date the items are revalued. Exchange rate gains and exchange rate losses arising from the payment of such transactions and when translating monetary assets and liabilities in foreign currency at the closing day rate, are reported in the income statement. The exception is when the transactions are hedges that fulfill the conditions for hedge accounting of cash flows or of net investments, when gains / losses are recognized in other comprehensive income. Exchange rate gains and losses related to loans and cash and cash equivalents, are recognized in the income statement as financial income or expenses. All other exchange rate gains and losses are reported net in the items other operating income or other operating expenses in the income statement

Group companies

The results of operations and financial positions of all Group companies that have different functional currencies than the presentation currency are translated to the Group's as follows: •assets and liabilities for each balance sheet are translated at closing day rates, •revenues and expenses for each income statement are translated at average rates of exchange and •all exchange rate differences arising are recognized in other comprehensive income.

Intangible and Tangible Assets

Intangible and tangible assets are recognized at cost after deductions for amortization and depreciation. The acquisition cost includes expenditure directly related to the acquisition of the asset. Additional expenditure is added to the asset's carrying amount or recognized as a separate asset, whichever is appropriate, only when it is likely that the future financial benefits associated with the asset will benefit the Group and the asset's acquisition value can be measured reliably. Expenditure for repairs and maintenance are reported as expenses in the income statement during the period in which they arise.

Depreciation and amortization is on a straight-line basis as follows:

Patents 16 years
Improvement to another's property 10 years
Licenses 5 years
Equipment, tools, fixtures and fittings 5 years

For development expenses, depreciation is started as soon as the asset is completed and can be used in the intended way.

Development expenditure that increases functionality and value is recognized as an intangible asset when the following criteria are satisfied:

  • it is technically and economically viable to complete the asset,
  • the intention and conditions exist to sell or use the asset,
  • it is likely that the asset will generate revenues or lead to cost savings and
  • expenditure can be measured satisfactorily.

Directly related expenditure capitalized as a portion of an intangible asset includes expenditure for employees and a reasonable share of indirect expenses. Other development expenses that do not satisfy the above criteria are expensed as they arise. Development expenses that had been previously expensed are not recognized as an asset in the subsequent period. The residual values and useful lives of assets are tested at each reporting date and restated as required.

The residual life of an asset is impaired to its recoverable amount immediately if the asset's carrying amount exceeds its estimated recoverable amount.

Impairment

Intangible assets that are not ready for use are not impaired, but rather subject to yearly impairment tests. Assets that are depreciated/amortized are subject to impairment tests whenever events or changed circum- stances indicate that the carrying amount may not be recoverable. Impairment is taken at an amount whereby the asset's carrying amount exceeds its recoverable amount. The recoverable amount is the greater of the asset's fair value less selling expenses and value in use. When measuring value in use, estimated future cash flows are discounted to present value by applying a discount rate before tax that reflects the current market assessment of the time value of money, and the risks associated with the asset. When conducting impairment tests, assets are grouped at the lowest level where there are essentially independent cash flows (cash-generating units). For assets that have been previously impaired, a test of reversal is conducted at each reporting date.

Financial Assets

The Group classifies its financial assets in the following categories: financial assets measured at fair value through profit or loss, loan receivables and accounts receivable, as well as saleable financial assets. This classification depends on the purpose for which the financial asset was purchased. Management determines the classification of financial assets on first-time recognition. At present, the Group only has financial assets in the loan receivables and accounts receivable category.

Financial assets valued at accrued acquisition cost

At present, the Group has only financial assets that are not normally sold outside the Group and where the purpose of the holding is to obtain contractual cash flows. All financial assets are classified as financial assets that are valued at accrued acquisition cost using the effective interest method.

Cash and cash equivalents

In the balance sheet and cash flow statements, cash and cash equivalents include cash, bank balances and other investments in securities, etc. with maturities within three months of the acquisition date. When acquiring financial assets, expected credit losses are reported continuously during the holding period, normally taking into account credit loss risk within the next 12 months. In the event that the credit risk has increased significantly, it is reserved for the credit losses that are expected to occur during the entire term of the asset. Immunovia applies the simplified method for calculating loan losses based on historical data regarding payment patterns and payment ability of the counterparty.

Based on historical data, the expected loan losses are judged to be extremely limited.

Equity

Share capital

Ordinary shares are classified as share capital.

Share issue expenses

Transaction expenses that are directly related to the issue of new ordinary shares or options are recognized net of tax in equity, as a deduction from the issue proceeds.

Dividend

Dividends to shareholders are reported as a liability in the financial reports in the period in which the dividend is determined by the company's shareholders

Financial Liabilities

Financial liabilities valued at accrued cost. The Group only has financial liabilities that are classified and valued at amortized cost using the effective interest method. Accounting is initially made at fair value, net after transaction costs.

Income Tax

The recognition of income taxes include current tax and deferred tax. Tax is recognized in the Income Statement, apart from those cases where it relates to items recognized directly in equity. In such cases, tax is also recognized in equity. Deferred tax is recognized pursuant to the balance sheet method on all temporary differences. A temporary difference exists when the book value of an asset or liability differs from its value for tax purposes. Deferred tax is measured by applying the tax rates that are enacted or substantively enacted on the reporting date, and are expected to apply when the affected tax asset is realized, or the tax liability is settled. Deferred tax assets are recognized to the extent it is likely that future taxable surpluses will exist against which the temporary differences can be utilized.

Revenue from Contracts With Customers

Revenue from contracts with customers is reported when the performance commitment is fulfilled and the control of a product or service is transferred to the customer. This assessment should be viewed from the customer's perspective, taking into account indications such as transfer of ownership and risks, customer acceptance, physical access and the right to invoice. Assessment must also be made if the control is transmitted at a certain time or over time. Net sales relate in their entirety to royalties, which is reported in accordance with the financial substance of each royalty agreement. Interest income is recognized as revenue over the term by applying the effective interest method.

Net sales refer to royalty payments in their entirety, which are reported according to the financial significance of the respective royalty agreements.

Contract Assets and Contractual Liabilities

The timing of revenue recognition, invoicing and payments leads to invoiced accounts receivable and uninvoiced accounts receivable. Uninvoiced accounts receivable (contract assets) are reported in the balance sheet under repaid expenses and accrued income. Invoiced but not yet provided services (contractual liabilities) are reported in the balance sheet under accrued expenses and prepaid income.

Recognition of Public Subsidies

Public subsidies are recognized at fair value providing there is reasonable assurance that the terms associated with the subsidy will be satisfied, and that thereby, the subsidy will be received. Subsidies received to cover expenses are recognized under the heading other income in the same period as the expenses arise. Subsidies relating to an asset reduce the asset's value in the balance sheet.

Leasing Agreements

IFRS 16 applied in 2019

Upon the transition to IFRS 16 and when signing new leases, a right-of-use asset and a leasing liability are recognized in the balance sheet. The acquisition value consists of the discounted remaining leasing fees for non-cancellable leasing periods. Possible extension periods are included if the Group is reasonably certain that these will be used. When discounting, the company uses marginal loan interest rates which are currently 4 percent.

The lease may change during the lease term, whereby the lease liability and the right-of-use asset are revalued. Leasing fees are divided between amortization of the leasing liability and payment of interest. The Group's significant leasing agreements consist of agreements regarding the leasing of office premises.

The company applies the relief rules regarding leasing agreements where the underlying asset has a low value and short-term leasing agreements. These leases are recognized as an expense in the period in which the use occurs.

IAS 17 applied in 2018

Leasing arrangements are classified either as finance or operating leases. Finance leases occur when the economic risks and rewards associated with the leased item are essentially transferred to the lessee. Otherwise, the arrangement is an operating lease. The Group has no material finance leases, and accordingly, all leases are recognized as operating leases, which means that lease payments are allocated on a straight-line basis over the lease term.

Employee Benefits

Liabilities for salaries and benefits and paid absence that is expected to be settled within 12 months of the end of the financial year, are recognized as current liabilities at the amount expected to be paid when the liabilities are settled, excluding discounts. All the group's pension obligations are in defined contribution plans. In a defined contribution plan, the company pays predetermined fees to an independent pension institution. When these contributions are paid, the company has no further obligations. Benefits such as salary and pensions are recognized as an expense in the period when employees have rendered the services that the compensation relates to.

Loan Expenses

Loan expenses that are directly attributable to the purchase, construction or production of qualified assets are reported as part of the acquisition value of these assets. Qualified assets are assets that necessarily take a considerable amount of time to complete for the intended use or sale. Capitalization ceases when all activities required to complete the asset for its use or sale have been substantially completed. All other loan expenses are expensed as they arise.

Cash Flow Statement

The cash flow statement has been prepared in accordance with the indirect method, which means that net earnings/losses are restated for transactions that do not involve any payments made or received in the period, and for any revenues and expenses relating to cash flow from investment or financing activities. Cash and cash equivalents include cash and immediately available balances with banks.

Parent Company's Accounting Principles

The Parent Company's accounting principles are unchanged compared with the previous year.

Participations in Subsidiaries

Participations in subsidiaries are recognized at cost after deducting for potential impairment. Cost includes acquisition-related expenses and potential additional purchase considerations. When there is an indication that participations in subsidiaries are impaired, recoverable amount is measured. If the recoverable amount is lower than the carrying amount, an impairment is taken. Impairment is recognized in the earnings/loss from participations in Group companies' items.

Financial Instruments

The parent company uses the exception regarding the application of IFRS 16 Leasing, which means that all leases are recognized as a cost on a straight-line basis over the lease period.

Leasing

The parent company uses the exception regarding the application of IFRS 16 Leasing, which means that all leases are recognized as a cost on a straight-line basis over the lease period.

NOTE 3 FINANCIAL RISK MANAGEMENT AND CAPITAL RISK

FINANCIAL RISK MANAGEMENT

Through its operations, the Group is exposed to various financial risks such as market risk (extensive currency risk and interest risk in cash flow), credit risk and liquidity risk. The Group's overarching risk management policy, which is adopted by the Board of Directors, is intended to minimize unfavorable effects on results of operations and financial position.

Market Risk

Currency Risk

The Group operates nationally and internationally, which means exposure to fluctuations in various currencies, and then primarily, the USD and EUR. Currency risk arises through future business transactions, and reported assets and liabilities. The scope of the company's operations means that, at present, net exposure in foreign currencies is limited. Accordingly, there is no policy prescribing hedging of this exposure. If the Swedish krona had depreciated or appreciated by 10 percent, with all other variables constant, adjusted earnings after tax as on December 31, 2019, would have been SEK 5.03 million (3.5) lower/higher, mostly as a consequence of gains and losses on the restatement of current receivables and liabilities. The corresponding impact on the parent company would have been SEK 5.04 million (3.5).

Interest Risk in Cash Flow

Interest risk is the risk that the value of financial instruments varies due to fluctuations in market interest rates. At present, the Group only has interest-bearing financial assets in the form of bank balances. On the basis of the financial interest-bearing assets and liabilities that accrue variable interest as of December 31, 2019, a one percentage point change in market interest rates would affect the Group's earnings by SEK 2.3 million (3.9) For the parent company, the corresponding effect would be SEK 2.6 million (3.9).

Credit Risk

Credit risk is the risk that a party in a transaction with a financial instrument is unable to fulfil its obligations. The maximum exposure for credit risks in financial assets as on December 31, 2019 is SEK 266.6 million (397.9). The corresponding figure for the parent company was SEK 315.3 million (415.3).

Liquidity Risk

Prudence in the management of liquidity risk means holding sufficient cash and cash equivalents or contracted credit facilities to be able to close market positions. Based on the current business plan, liquidity would be sufficient for some 1.5 years. The maturity structure of the group's financial liabilities is stated below.

SEK 000 Within 3 mth Between 3
mth. and 1 yr
Between 1 yr
and 2 yr
Between 2 yr
and 5 yr
Later than
5 yr
Leasing liability 1,590 4,770 6,360 20,306 11,087
Accounts payable 5,830 0 0 0 0
Accrued expenses 10,184 0 0 0 0
Total 17,604 4,770 6,360 20,306 11,087

Financial Liabilities as on December 31, 2019 become due for payment:

Managing Capital Risk

The Group's goal in terms of capital structure, defined as equity, is to secure the company's ability to continue its operations to enable it to generate returns to shareholders and benefits to other stakeholders, and that its capital structure is optimal considering the cost of capital. Dividends to shareholders, redemption of shares, issuance of new shares or sales of assets are examples of actions the company could use to adjust its capital structure.

The Group's Debt/Equity Ratio

SEK000 2019
Total interest-bearing liabilities 38,066
Less: interest-bearing assets 266,470
Net debt –228,404
Total equity 357,604
Net debt/equity ratio (%) -64

Net debt Interest-bearing liabilities less interest-bearing assets (including cash and cash equivalents). Net debt/equity ratio Net debt in relation to equity.

NOTE 4 SIGNIFICANT ESTIMATES AND JUDGEMENTS FOR ACCOUNTING PURPOSES

The most important assumptions regarding the future and other sources of uncertainty in estimates as of the reporting date, which involve significant risk of material restatements in the carrying amounts of assets and liabilities in the following financial years are stated below. The greatest uncertainty is within intangible assets. Intangible assets have not yet started amortization, and accordingly, are subject to annual impairment tests.

Impairment tests are based on a review of recoverable amount, which is estimated on the basis of the value in use of assets. Management makes estimates of future cash flows in accordance with internal business plans and forecasts. Estimates of the discount rate and future growth rates beyond the determined budgets and forecasts are used in this review. The carrying amount of intangible assets is SEK 91.9 million (61.8), of which capitalized development expenditure amounts to SEK 71.2 million (44.8) and SEK 20.6 million (17) consists of patents and licenses. Changes to the assumption management employed in impairment tests could have a material effect on the company's results of operations and financial position. For further information see Note 13.

NOTE 5 SEGMENT INFORMATION

Business segments are reported in a manner that is consistent with the internal reporting presented to the chief operating decision maker. The chief operating decision maker is that function responsible for allocating resources and judging the performance of operating segments. In the Group, this function has been identified as management, which consists of seven individuals including the CEO. Management has determined that the group as a whole is a single segment based on information considered in consultation with the board used as supporting data to allocate resources and evaluate performance Of the Group's assets, SEK 135.7 million (69.9) are in Sweden, SEK 14.2 million (8.5) in the US and SEK 349,000 (426) in Germany.

The Group's net sales consist of royalty revenues that have been invoiced in their entirety from Sweden. Customers are mainly located in the US. The Group has a customer that accounts for 10 percent or more of the company's revenue. This customer accounts for SEK 317,000 of net sales.

NOTE 6 INTRA-GROUP PURCHASES AND SALES

Parent company
2019 2018
Share of sales relating to Group companies 0% 0%
Share of purchases relating to Group companies 1% 1%

NOTE 7 OTHER OPERATING INCOME

The Group Parent company
2019 2018 2019 2018
Other diverse income 356 221 356 221
Exchange rate gains 102 523 102 523
Total 458 744 458 744

NOTE 8 LEASING AGREEMENTS

Until January 1, 2019, the Group was lessee through operational leasing agreements for office premises. As a result of the transition to IFRS 16 Leasing, all leasing agreements are reported in the balance sheet, except short-term leasing and lesser value leasing. As of at the closing date, the Group had leases for office premises reported as a right-of-use asset in the balance sheet. The remaining leasing fees have been calculated at current value using the Group's marginal loan interest rate, which was 4 percent. As at January 1, 2019, the following adjustments have been made in the Comments on the balance sheet.

SEK000

Tangible assets, right-of-use assets 36,067
Current receivables, Prepaid costs -610
35,457
Interest-bearing liabilities - long-term, Leasing liability 31,450
Interest-bearing liabilities - short-term, Leasing liability 4,007
35,457

Since the value of the right-of-use assets and the leasing liability amounts to the same, equity is not affected.

Reconciliation between operational leasing obligations in accordance with IAS 17 and leasing liability in accordance with IFRS 16.

SEK000

.

Operating lease commitments as at December 31, 2018 20,586
Extension period to come 21,806
Total 42,392
Effect of current value calculation -6,325
Advance payment -610
Reported leasing liability 35,457
Amounts recognized in earnings/loss
Depreciation on right-of-use assets 4,596
Interest expense for leasing liabilities 1,316
Expenses attributable to low value leasing contracts -71
Expenses attributable to variable fees not included in the valuation of the
leasing liability -23

On December 31, 2019, the Group had obligations regarding short-term leasing agreements of SEK 0. The total cash flow for leases amounted to SEK 6.4 million.

The Group Parent Company
2019 2018 2019 2018
Operational leasing, incl rent for premises
Lease payments, expense for the year 0 3,482 3,908 2,050
Remaining lease payments become due as
follows:
Within 1 year 0 5,307 4,541 3,540
Later than 1 year but within 5 years. 0 15,279 9,082 9,735
Later than 5 years 0 0 0 0
Total 0 20,586 13,623 13,275

NOTE 9 REMUNERATION TO THE AUDITORS

The Group Parent Company
2019 2018 2019 2018
Remuneration to the auditors
Revisionsbyrån Auditoriet AB
Audit assignments 260 0 260 0
Other services 40 0 40 0
300 0 300 0
Mazars SET Revisionsbyrå
Audit assignments 160 241 160 241
Other services 110 115 110 115
384 356 270 357
Other auditing firms
Other services 384 61 0 0
384 61 0 0
Total 954 417 570 357

NOTE 10 EMPLOYEES AND PERSONNEL EXPENSES

Average number of employees

2019 2018
No. of employees Of which
male
No. of employees Of which
male
Parent company
Sweden 38 14 30 13
Subsidiaries
USA 9 2 8 2
Germany 1 0 1 0
Total subsidiaries 10 2 9 2
The Group total 48 16 39 15
Gender balance, senior executives
2019 2018
Female Male Female Male
The Board 2 3 3 3
CEO and other management 3 4 3 4

Personnel expenses

2019 2018
Salaries and
benefits
Social se
curity contri
butions
Salaries and
benefits
Social secu
rity contri
butions
Parent company
The Board and CEO 3,463 3,172 3,587 2,865
(of which pension expenses) (661) (720)
Other employees 22,880 9,017 18,336 7,509
(of which pension expenses) (2,277) (2,333)
Subsidiaries
Other employees 13,127 2,544 10,903 1,935
(of which pension expenses) (455) (380)
The Group total 39,470 14,733 32,826 12,309
(of which pension expenses) (3,393) (3,433)

Senior executives mean the individuals that make up the company's management with the CEO. There are seven people in this group. Fees are payable to the Chairman of the Board and Directors pursuant to AGM resolution. The following table illustrates compensation received.

Personnel expenses 2019. Board of Directors, CEO, and Senior Executives

Salary &
benfits/
Pension Other
Name Position directors' fee expenses benefits Total
Carl Borrebaeck Chairman 420 0 0 420
Hans Johansson Director 170 0 0 170
Åsa Hedin Director 63 0 0 63
Christofer Sjögren Director 177 0 0 177
Mimmi Ekberg Director 150 0 0 150
Ann-Christine Sundell Director 190 0 0 190
Total, Board 1,170 0 0 1,170
Mats Grahn CEO 3,020 660 0 3,680
Other senior executives 5,542 691 2,017 8,250
Total CEO and other senior
executives
8,562 1,351 2,017 11,930

Personnel expenses 2018. Board of Directors, CEO, and Senior Executives

Salary &
benefits/
Pension Other
Name Position directors' fee expenses benefits Total
Carl Borrebaeck Chairman 360 0 0 360
Hans Johansson Director 153 0 0 153
Åsa Hedin Director 173 0 0 173
Christofer Sjögren Director 100 0 0 100
Mimmi Ekberg Director 100 0 0 100
Ann-Christin Malmborg Hager Director 33 0 0 33
Ann-Christine Sundell Director 167 0 0 167
Total, Board 1,086 0 0 1,086
Mats Grahn CEO 2,511 720 0 3,231
Other senior executives 5,235 822 2,186 8,243
Total CEO and other senior executives 7,746 1,542 2,186 11,474

The CEO has a notice period of six months on resignation. A notice period of six months applies to termination by the company. Other compensation to senior executives wholly consists of invoiced fees and compensation for service in management. The Board of Directors and senior executives are members of share warrant schemes, whose terms are stated below. The Group's only pension obligations are in defined contribution plans. In defined contribution plans, the company pays predetermined charges to insurance companies. Retirement age is 65. For CEO Mats Grahn, the company pays a fixed premium of 22 percent of his salary.

Share Warrants

Name Position

Name Position

Total CEO and other senior

Salary & benfits/ directors' fee

Carl Borrebaeck Chairman 420 0 0 420 Hans Johansson Director 170 0 0 170 Åsa Hedin Director 63 0 0 63 Christofer Sjögren Director 177 0 0 177 Mimmi Ekberg Director 150 0 0 150 Ann-Christine Sundell Director 190 0 0 190 Total, Board 1,170 0 0 1,170 Mats Grahn CEO 3,020 660 0 3,680 Other senior executives 5,542 691 2,017 8,250

executives 8,562 1,351 2,017 11,930

Carl Borrebaeck Chairman 360 0 0 360 Hans Johansson Director 153 0 0 153 Åsa Hedin Director 173 0 0 173 Christofer Sjögren Director 100 0 0 100 Mimmi Ekberg Director 100 0 0 100 Ann-Christin Malmborg Hager Director 33 0 0 33 Ann-Christine Sundell Director 167 0 0 167 Total, Board 1,086 0 0 1,086 Mats Grahn CEO 2,511 720 0 3,231 Other senior executives 5,235 822 2,186 8,243 Total CEO and other senior executives 7,746 1,542 2,186 11,474

Salary & benefits/ directors' fee

Pension expenses

Pension expenses

Other

benefits Total

Other

benefits Total

At the AGM on April 26, 2019, an option program of series 2019/2023 series was approved for employees and key personnel in the company. The share warrants (191,000, of which 47,500 are subscribed) can be exercised to subscribe for new shares in the company from June 1, 2023 until June 30, 2023. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 342.06 per share. Upon full exercise, the company's share capital increases by SEK 9,550.00.

At the AGM on May 3, 2018, an option program of series 2018/2021 was approved for employees and key persons in the company. The share warrants (156,150) can be exercised to subscribe for new shares in the company from September 7, 2021 and until October 7, 2021. Each warrant gives the right to subscribe for one share at a subscription price of SEK 271.05 per share. Upon full exercise, the company's share capital will increase by SEK 7,807.50.

The AGM on April 25, 2017 resolved on a share warrant program designated series 2017/2020 for employees and key individuals of the company. The share warrants (61,000 warrants) can be exercised to subscribe for new shares of the company in the exercise period September 15, 2020 until October 15, 2020 inclusive. Each share warrant confers entitlement to subscribe for one share at a subscription price of SEK 205.00 per share. Upon full exercise, the company's share capital will increase by SEK 3,050.

It was resolved at the Annual General Meeting on April 26, 2019, to introduce an alternative cash-based incentive scheme for key employees in countries where the allocation of warrants under warrants program 2019/2023 was not appropriate for various reasons. Such an alternative incentive scheme has been introduced for employees and key persons and is designed in such a way that it corresponds to the terms of the warrants program 2019/2023 to its economic effect. The total cost for the Company for the cash-based incentive scheme cannot exceed USD 520,000.

It was resolved at the Annual General Meeting on May 3, 2018 to introduce an alternative cash-based incentive scheme for key employees in countries where the allocation of warrants under warrants program 2018/2021 was not appropriate for various reasons. Such an alternative incentive scheme has been introduced for employees and key persons and is designed in such a way that it corresponds to the terms of the warrants program 2018/2021 to its economic effect. The total cost for the Company for the cash-based incentive scheme cannot exceed USD 250,000.

It was decided at the Annual General Meeting on April 25, 2017 to introduce an alternative cash-based incentive scheme for key employees in countries where the allocation of warrants under the warrants program 2017/2020 was not appropriate for various reasons. Such an alternative incentive scheme has been introduced for 6 key persons and is designed in such a way that it corresponds to the terms of the warrants program 2017/2020 to its economic effect. The total cost for the Company for the cash-based incentive scheme may not exceed USD 920,000.

All option programs are subject to customary conversion conditions in connection with issues etc.

In addition to what has been stated above, the company has no outstanding warrants, convertibles or other equity-related financial instruments.

NOTE 11 FINANCIAL INCOME/INTEREST INCOME AND SIMILAR EARNINGS ITEMS

The Group Parent Company
2019 2018 2019 2018
Interest income Group companies 0 0 1,227 578
Exchange rate income 3,535 859 3,484 859
Interest income, other 285 319 270 306
Total 3,820 1,178 4,981 1,743

NOTE 12 FINANCIAL EXPENSES/INTEREST EXPENSES AND SIMILAR EAR-NINGS ITEMS

The Group Parent Company
2019 2018 2019 2018
Interest expenses Group companies 0 0 0 0
Exchange rate losses -2,771 0 -2,719 0
Interest expenses for leas liabilities -1316 0 0 0
Interest expenses other -2 -1 -2 -1
Total -4,089 -1 -2,721 -1

NOTE 13 TAX ON EARNINGS FOR THE YEAR

The Group Parent Company
Dec 31,
2019
Dec 31,
2018
Dec 31,
2019
Dec 31,
20181
Current tax -4 -7 0 0
Deferred tax 0 0 0 0
Total -4 -7 0 0
The Group Parent Company
Dec 31, 2019 Dec 31, 2018 Dec 31, 2019 Dec 31, 2018
Theoretical tax
Reported earnings/loss before tax -114,517 -86,531 -90,531 -66,334
Tax at applicable tax rate, 21.4% (22%) 24,507 19,037 19,374 14,593
Reconciliation of reported tax
Effect of non-deductible expenses -96 –25 -96 26
Effect of non-taxable revenues 0 0 0 0
Issue expenses recognized in equity 0 –25 0 3 231
Effect of loss carry-forwards that have not
been measured -24,411 –22,243 -19,278 -17,799
Impact attributable to previous years -4 –7 0 0
Total -4 -7 0 0

Deductible loss carry-forwards in the Group amounted to SEK 304.5 million (192.0) as on December 31, 2019. For the Parent company, deductible loss carry-forwards amounted to SEK 261.9 million (171.8) as on December 31, 2018. All loss carry-forwards have no time limitation. The effect of issue expenses is reported in equity. No tax loss carry-forwards have been valued.

The Group Parent Company
Dec 31, 2019 Dec 31, 2018 Dec 31, 2019 Dec 31, 2018
Opening cost 88,640 64,413 88,640 64,413
Investment 26,715 25,052 26,715 25,052
Adjustment 0 -825 0 -825
Total 115,355 88,640 115,355 88,640
National and European subsidies of deve
lopment expenditure
Opening balance -43,851 –41,886 -43,851 -41,886
Deducted in the year -291 -2,791 -291 -2,791
Adjustment 0 825 0 825
Total -44,142 -43,852 -44,142 -43,851
Carrying amount 71,213 44,788 71,213 44,788

NOET 14 CAPITALIZED DEVELOPMENT EXPENDITURE

Capitalized development expenditures are depreciated from the time they are completed and can be used in the intended manner. The majority of the capitalized development expenditure was not completed on the balance sheet date but is expected to be completed during the coming financial year.

Impairment testing has been carried out for capitalized development expenditure. Significant factors in the test have been to assess cash flows for the next five years, assess growth after the forecast period and the weighted capital cost, which is calculated at 8.5 percent. The forecasts used in the impairment test are approved by the management and are based on the best assessment of the future. The growth rate beyond that forecast period is set at 2 percent, which is a conservative estimate as it is set at expected long-term inflation. A sensitivity analysis shows that an impairment requirement arises at an increased weighted capital cost of 22 percentage units or at a turnover decrease of about 23 percent and otherwise unchanged factors. A shift in sales start of about 1 year also means that an impairment need arises.

NOTE 15 PATENTS, LICENSES AND SIMILAR RIGHTS

The Group Parent Company
Dec 31, 2019 Dec 31, 2018 Dec 31, 2019 Dec 31, 2018
Opening cost 18,270 15,298 17,352 15,298
Investment 3,853 3,178 3,853 2,288
Sales and scrapping 0 -234 0 -234
Translation differences for the year 35 29 0 0
Closing accumulated cost 22,158 18,271 21,205 17,352
Opening amortization -674 -435 -674 -435
Amortization for the year -239 -239 -239 -239
Closing accumulated amortization -913 -674 -913 -674
Opening impairment -599 -599 -599 -599
Closing accumulated impairment -599 -599 -599 -599
Carrying amount 20,646 16,998 19,693 16,080

The Group Parent Company
Dec 31, 2019 Dec 31, 2018 Dec 31, 2019 Dec 31, 2018
Opening cost 3,353 0 2,300 0
Purchase 3,029 3,320 3,029 2,300
Translation difference for the year 40 33 0 0
Closing accumulated cost 6,422 3,353 5,329 2,300
Opening amortization -49 0 0 0
Amortization for the year -613 -47 -547 0
Translation difference for the year -0 -2 0 0
Closing accumulated amortization -662 -49 -547 0
Carrying amount 5,760 3,304 4,782 2,300

NOTE 16 IMPROVEMENTS IN OTHER'S PROPERTY

NOTE 17 EQUIPMENT, TOOLS, FIXTURES AND FITTINGS

The Group Parent Company
Dec 31, 2019 Dec 31, 20181 Dec 31, 2019 Dec 31, 2018
Opening cost 15,136 9,119 10,355 6,506
Purchases 3,005 5,737 2,951 3,849
Translation difference for the year 173 280 0 0
Closing accumulated cost 18,314 15,136 13,306 10,355
Opening depreciation -4,421 -1,908 -3,667 - 1,909
Depreciation for the year -2 999 - 2,492 -2,164 -1,757
Translation difference for the year -15 -21 0 0
Closing accumulated depreciation -7 435 -4,421 -5,831 -3,666
Carrying amount 10,879 10,715 7,475 6,689

NOTE 18 RIGHT-OF-USE ASSETS, LEASING

The Group
Dec 31, 2019
Opening cost 36,067
Purchases 7,114
Closing accumulated cost 43,181
Opening depreciation 0
Depreciation for the year -4,596
Closing accumulated depreciation -4,596
Carrying amount 38,585

NOTE 19 OTHER LONG-TERM RECEIVABLES

The Group
Dec 31, 2019 Dec 31, 2018
Opening acquisition value 3,008 2,759
Lending for the year 0 3
Translation difference for the year 17 246
Carrying amount 3,125 3,008

NOTE 20 PREPAID EXPENSES AND ACCRUED INCOME

The Group Parent Company
Dec 31, 2019 Dec 31, 2018 Dec 31, 2019 Dec 31, 2018
Prepaid rents 28 939 1 136 936
Prepaid insurance 73 121 73 40
Prepaid expenses for prospective studies 1,214 1,676 1,214 1,676
Other prepaid expenses 1,089 939 862 939
Accrued income 131 252 131 252
Carrying amount 2,535 3,928 3,416 3,843

NOTE 21 PARTICIPATIONS IN GROUP COMPANIES

Carrying amount
Company Corporate I.D
no.
Reg. office No. Participa
ting interest
Dec 31,
2019
Dec 31,
2018
Immunovia Inc 350589-6 Wilmington, USA 1,000 100% 1 1
Immunovia
Incentive AB
559198-2870 Lund 500 100% 50 0
Immunovia
GmbH
HRB 111 597 Frankfurt am Main 1 100% 253 253
303 253

NOTE 22 EQUITY

The number of shares amounts to 19,654,853, each with one vote. The quotient value is SEK 0.05 per share

NOTE 23 ACCRUED EXPENSES AND PREPAID INCOME

The Group Parent Company
Dec 31, 2019 Dec 31, 2018 Dec 31, 2019 Dec 31, 2018
Personnel-related e expenses 6,113 7,270 5,940 7,125
Accrued study expenses 6,621 2,651 6,621 2,651
Other Accrued expenses 3,616 1,358 3,410 1,297
Carrying amount 16,350 11,279 15,971 11,073

NOTE 24 NON-CASH FLOW ITEMS

The Group Parent Company
Dec 31, 2019 Dec 31, 2018 Dec 31, 2019 Dec 31, 2018
Depreciation 8,447 2,777 2,950 1,996
Disposal of intangible assets 0 234 0 234
Translation difference internal transac
tions
-3 - 329 0 0
Total 8,444 2,682 2,950 2,230

NOTE 25 EFFECT OF FINANCIAL LIABILITIES ON CASAH FLOW

The Group
Dec 31, 2019
Opening acquisition value on transition to IFRS 16 36, 067
Additional leasing liabilities 7,114
Amortization during the year, affecting cash flow -5,115
Carrying amount 38,066

NOTE 26 CASH AND CASH EQUIVALENTS

The Group Parent Company
Dec 31, 2019 Dec 31, 2018 Dec 31, 2019 Dec 31, 2018
Cash 0 0 0 0
Bank balances 263,345 386,136 261,647 385,517
Total cash and cash equivalents 263,345 386,136 261,647 385,517
The Group Parent Company
Dec 31, 2019 Dec 31, 2018 Dec 31, 2019 Dec 31, 2018
Financial assets valued at accrued acqui
sition value
Other non-current receivables 3,125 3,008 0 0
Accounts receivable 0 32 0 32
Other receivables 0 8,473 53 5,79 29,984
Accrued income 131 252 131 252
Cash and cash equivalents 263,345 386,136 261,647 385,517
266,601 397,901 315,357 415,753
Financial liabilities valued at accrued
acquisition value
Leasing liabilities 38,066 0 0 0
Accounts payable 5,426 3,031 5,022 3,007
Accrued expenses 10,237 5,120 10,031 3,948
53,729 8,151 15,053 6,955

NOTE 27 FINANCIAL INSTRUMENTS BY CATEGORY

Financial assets valued at accrued acquisition value

At present, the Group only has financial assets that are not normally sold outside the Group and where the purpose of the holding is to obtain contractual cash flows. All financial assets are classified as financial assets that are valued at amortized cost using the effective interest method. The Group applies the simplified method for calculating expected credit losses. The method means that expected losses during the entire duration of the receivables are used as a starting point for loss risk reserve. The Group is currently very limited with accounts receivable, so no loss reserve is calculated. The parent company has receivables from subsidiaries for which there is not deemed to be any significant expected loss risk.

Financial liabilities valued at accrued acquisition value

The Group only has financial liabilities that are classified and valued at accrued acquisition value using the effective interest method. Accounting is initially made at fair value, net after transaction expenses.

The carrying amount on financial assets and liabilities is considered to be essentially consistent with fair value.

NOTE 28 SIGNIFICANT EVENTS SINCE 2019 AND COMMENTS FROM THE CEO

I want to take this opportunity to discuss significant events that have occurred since the close of 2019, both at Immunovia and in the world. In light of these extraordinary times and COVID-19, I want to reassure everyone that Immunovia remains on-track to launch the very first test for early diagnosis of pancreatic cancer, IMMray™ PanCan-d, in the US market during Q3 2020. Any effects by the global pandemic on our business and the launch plans have, thus far, been mitigated and/ or adapted to accommodate the associated challenges and currently create no impact on the Q3 launch.

Additionally, Immunovia has had some additional events following the close of 2019 which include:

• The building up of the Company's management team with a new Senior Vice President of Sales NA (North America), Michael Pettigrew. Michael brings with him a very successful track record in product launches and sales growth, couple with a unique set of leadership skills. Michael is a great addition to Immunovia.

• A visit from the Crown Princess of Sweden and Prince Daniel who came to Immunovia at the end of January. The delegation included the Governor of Skåne County, Anneli Hultén and additional representatives from Skåne County Administrative Board and the Royal Court. We are grateful to The Crown Princess of Sweden and Prince Daniel for their interest in our company and in IMMray™ – state-of-the-art technology as part of their engagement to promote Swedish innovations.

With two milestones remaining – a Verification study and a final Validation study – before the commercialization of IMMray™ PanCan–d during Q3 2020, we are intensifying the final launch preparations. We have successfully established a network of world-renowned Key Opinion Leaders and healthcare specialists, who have collaborated with us on how the test should be used in practice. Our production facility is ready with ample capacity and the company's well established infrastructure is fully prepared for the final accreditations.

I am confident that, with our great team assembled under the Immunovia name, we will do our utmost to adjust to any further unforeseen circumstances and will continue our commercialization efforts to ensure a successful launch of IMMray™ PanCan–d . Immunovia is targeting an initial addressable market of USD 4.4 billion in the US and Europe, and we look forward to working with healthcare providers around the world to improve the situation of this affected patient group.

NOTE 29 TRANSACTIONS WITH RELATED PARTIES

Remuneration to the Board of Directors and senior executives is stated in note 9.

In addition to salaries and other remuneration to the executive management and board fees, according to a Resolution by the AGM, the company has also entered into a consultancy agreement with CB Ocean Capital AB for Services to be performed by Immunovia's chairman and its largest owner Carl Borrebaeck. The services provided do not include tasks that belong to board assignments, but the services are aimed at providing the company with scientific and strategic support for, for example, scientific presentations and conferences. The agreement applies from January 1, 2018 and runs until further notice with a three-month mutual notice period and provides a quarterly remuneration of SEK 41,000.

NOTE 30 APPROPRIATION OF EARINGS/LOSS

Proposed appropriation of the company's earnings/loss

The following funds are at the disposal of
the AGM (SEK):
Share premium reserve 10,231,975
Earnings brought forward 416,204,494
Earnings/loss for the year -90,530,764
335,905,705
The Board of Directors proposes:
Carried forward 335,905,705
335,905,705

Board of Directors' and Chief Executive Officer's Certification

The Consolidated Income Statement and Consolidated Balance Sheet will be presented to the Annual General Meeting on May 7, 2020 for adoption.

The Board of Directors and Chief Executive Officer hereby certify that the Consolidated Accounts have been Prepared in accordance with International Financial Reporting Standards, IFRS, as endorsed by the EU and give a true and fair view of the Group's financial position and results of operations. The financial statements for the parent company have been prepared in accordance with generally accepted accounting practice and give a true and fair view of the parent company's financial position and results of operations.

The Statutory Administration Report of the Group and parent company gives a true and fair view of the progress of the Group's and parent company's operations, financial position and results of operations, and states the material risks and uncertainty factors facing the parent company and companies in the Group.

Lund, Sweden March 20, 2020

Carl Borrebaeck Chairman

Hans Johansson Board member

Ann-Christine Sundell Board member

Christofer Sjögren Board member

Mimmi Ekberg Board member Mats Grahn Chief Executive Officer

Our Audit Report was presented on March 20, 2020

Mats-Åke Andersson Authorized Public Accountant Auditor in Charge

The consolidated income statement and consolidated balance sheet, and the parent company's income statement and parent company's balance sheet will be subject to adoption at the Annual General Meeting.

Audit Report

To the general meeting of the shareholders of Immunovia AB (Publ.), corporate ID no. 556730-4299

Report on the annual accounts and consolidated accounts

Opinions

I have audited the annual accounts and consolidated accounts of Immunovia AB (Publ.) for the year 2019. The annual accounts and consolidated accounts of the Company are included on pages 38-71 in this document. In my opinion, the annual accounts have been prepared in accordance with the Annual Accounts Act and present fairly, in all material respects, the financial position of the Parent Company as of December 31, 2019 and its financial performance and cash flow for the year then ended in accordance with the Annual Accounts Act. The consolidated accounts have been prepared in accordance with the Annual Accounts Act and present fairly, in all material respects, the financial position of the Group as of December 31, 2019 and their financial performance and cash flow for the year then ended in accordance with International Financial Reporting Standards (IFRS), as adopted by the EU, and the Annual Accounts Act. The statutory administration report is consistent with the other parts of the annual accounts and consolidated accounts.

I therefore recommend that the general meeting of shareholders adopts the income statement and balance sheet for the Parent Company and the Group. My opinions in this report on the annual accounts and the consolidated accounts are consistent with the content of the supplementary report submitted to the parent company's audit committee in accordance with Article 11 of the audit regulation (537/2014/EU).

Basis for Opinions

I conducted my audit in accordance with International Standards on Auditing (ISA) and generally accepted auditing standards in Sweden. My responsibilities under those standards are further described in the Auditor's responsibilities section. I am independent in my relationship with the Parent Company and the Group in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled my ethical responsibilities in accordance with these requirements. This includes, based on my best knowledge and beliefs, no prohibited services referred to in Article 5 (1) (537/2014/EU) of the Auditors Regulations, the audited company or, where applicable, its parent company or its controlled companies within the EU has been provided. I believe that the audit evidence I have obtained is sufficient and appropriate to provide a basis for my opinions.

Particularly Important Areas

Particularly important areas for the audit are the areas that, according to my professional assessment, were the most important for the audit of the annual accounts and consolidated accounts for the current period and include, among other things, the most important assessed risks for material misstatements. These areas were treated within the framework of the audit of, and in my opinion on, the annual accounts and the consolidated accounts as a whole, but I make no separate statements about these areas.

Intangible Fixed Assets

The intangible fixed assets are presented in more detail in notes 2, 4, 14 and 15. As of December 31, 2019, the Group's carrying amount of intangible fixed assets amounts to SEK 91,859,000 and constitutes a significant part of the Group's reported assets. In accordance with applied accounting principles, certain conditions exist for the fact that capitalization of expenses can take place, see also Note 2, and partly the executive management make an annual impairment test regarding the asset. The management has made impairment tests based on discounted cash flow. The calculations include a high degree of assessments and assumptions about future cash flows and conditions that are complex. Notes 4 and 14 contain an account of which parts have been tested, how the assessments have been made, important assumptions and the outcome of sensitivity analyzes.

I have formed an understanding of the company's operations and market, assessed the calculation model used by the management and took note of the estimates and assessments made. The management's assumptions mainly linked to the variables that have the greatest impact on impairment testing, such as growth, margins and the discount factor have been tested by us.

I have tested what effect changes in assumptions regarding the above-mentioned variables have on the trials. This is to assess whether an impairment requirement exists. Assessment has been made of the accuracy of the disclosures in the annual accounts.

Other Information Than the Annual Accounts and Consolidated Accounts

This document also contains other information than the annual accounts and consolidated accounts and is found on pages 2–37 and 76-79. The Board of Directors and the CEO are responsible for this other information.

My opinion on the annual accounts and consolidated accounts does not cover this other information and I do not express any form of assurance conclusion regarding this other information. In connection with my audit of the annual accounts and consolidated accounts, my responsibility is to read the information identified above and consider whether the information is materially inconsistent with the annual accounts and consolidated accounts. In this procedure I also take into account my knowledge otherwise obtained in the audit and assess whether the information otherwise appears to be materially misstated. If I, based on the work performed concerning this information that I have had access to prior the date of this auditor's report, conclude that there is a material misstatement of this other information, I am required to report that fact. I have nothing to report in this regard.

Responsibilities of the Board of Directors and the Chief Executive Officer

The Board of Directors and the CEO are responsible for the preparation of the annual accounts and consolidated accounts and that they give a fair presentation in accordance with the Annual Accounts Act and, concerning the consolidated accounts, in accordance with IFRS as adopted by the EU. The Board of Directors and the CEO are also responsible for such internal control as they determine is necessary to enable the preparation of annual accounts and consolidated accounts that are free from material misstatement, whether due to fraud or error.

In preparing the annual accounts and consolidated accounts, The Board of Directors and the CEO are responsible for the assessment of the company's and the Group's ability to continue as a going concern. They disclose, as applicable, matters related to going concern and using the going concern basis of accounting. The going concern basis of accounting is however not applied if the Board of Directors and the CEO intends to liquidate the company, to cease operations, or has no realistic alternative but to do so. The Board's Audit Committee shall, without prejudice to the Board's responsibilities and tasks in general, monitor, among other things, the Company's financial reporting.

Auditors' Responsibility

My objectives are to obtain reasonable assurance about whether the annual accounts and consolidated accounts as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor's report that includes my opinions. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs and generally accepted auditing standards in Sweden will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these annual accounts and consolidated accounts.

As part of an audit in accordance with ISAs, I exercise professional judgment and maintain professional skepticism throughout the audit. I also:

• Identify and assess the risks of material misstatement of the annual accounts and consolidated accounts, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for my opinions. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control.

• Obtain an understanding of the company's internal control relevant to my audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company's internal control.

• Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made by the Board of Directors and the CEO.

• Conclude on the appropriateness of the Board of Directors' and the CEO's use of the going concern basis of accounting in preparing the annual accounts and consolidated accounts. I also draw a conclusion, based on the audit evidence obtained, as to whether any material uncertainty exists related to events or conditions that may cast significant doubt on the company's and the Group's ability to continue as a going concern. If I conclude that a material uncertainty exists, I am required to draw attention in my auditor's report to the related disclosures in the annual accounts and consolidated accounts or, if such disclosures are inadequate, to modify my opinion about the annual accounts and consolidated accounts. My conclusions are based on the audit evidence obtained up to the date of my auditor's report. However, future events or conditions may cause a company and a group to cease to continue as a going concern.

• Evaluate the overall presentation, structure and content of the annual accounts and consolidated accounts, including the disclosures, and whether the annual accounts and consolidated accounts represent the underlying transactions and events in a manner that achieves fair presentation.

• Obtain sufficient and appropriate audit evidence regarding the financial information of the entities r business activities within the Group to express an opinion on the consolidated accounts. I am responsible alone for the direction, supervision and performance of the Group audit. I remain solely responsible for my opinions.

I must inform the Board of Directors of, among other matters, the planned scope and timing of the audit. I must also inform of significant audit findings during my audit, including any significant deficiencies in internal control that I identified. I must also provide the Board with a statement that I have complied with relevant professional ethical requirements regarding independence, and to address all relations and other conditions that can reasonably affect my independence, and, if applicable, associated countermeasures. Of the areas communicated with the Board, I determine which of these areas have been the most important for the audit of the annual accounts and the consolidated accounts, including the most important assessed risks for material misstatements, and which therefore constitute the areas of particular importance to the audit. I describe these areas in the auditor's report unless laws or other regulations prevent information about the issue or when, in extremely rare cases, I consider that an issue should not be communicated in the audit report because the negative consequences of doing so reasonably would be expected to be greater than the public interest in this communication.

Report on Other Legal and Regulatory Requirements

Opinions

In addition to my audit of the annual accounts and consolidated accounts, I have also audited the administration of the Board of Directors and the CEO of Immunovia AB (Publ.) for the year 2019 and the proposed appropriations of the company's profit or loss.

I recommend to the general meeting of shareholders that the profit be appropriated in accordance with the proposal in the statutory administration report and that the members of the Board of Directors and the CEO be discharged from liability for the financial year.

Basis for Opinions

I conducted the audit in accordance with generally accepted auditing standards in Sweden. My responsibilities under those standards are further described in the Auditor's responsibilities section. I are Independent of the Parent Company and the Group in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled my ethical responsibilities in accordance with these requirements. I believe that the audit evidence I have obtained is sufficient and appropriate to provide a basis for my opinions.

Responsibilities of the Board of Directors and the Chief Executive Officer

The Board of Directors is responsible for the proposal for appropriations of the company's profit or loss. At the proposal of a dividend, this includes an assessment of whether the dividend is justifiable considering the requirements which the company's and the Group's type of operations, size and risks place on the size of the Company's and the Group's equity, consolidation requirements, liquidity and position in general. The Board of Directors is responsible for the company's organization and the administration of the company's affairs. This includes among other things continuous assessment of the company's and the Group's financial situation and ensuring that the company's organization is designed so that the accounting, management of assets and the company's financial affairs otherwise are controlled in a reassuring manner. The CEO shall manage the ongoing administration according to the Board of Directors' guidelines and instructions and among other matters take measures that are necessary to fulfil the company's accounting in accordance with law and handle the management of assets in a reassuring manner.

Auditor's Responsibility

My objective concerning the audit of the administration, and thereby my opinion about discharge from liability, is to obtain audit evidence to assess with a reasonable degree of assurance whether any member of the Board of Directors or the CEO in any material respect:

• has undertaken any action or been guilty of any omission which can give rise to liability to the company, or

• in any other way has acted in contravention of the Companies Act, the Annual Accounts Act or the Articles of Association. My objective concerning the audit of the proposed appropriations of the company's profit or loss, and thereby my opinion about this, is to assess with reasonable degree of assurance whether the proposal is in accordance with the Companies Act. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with generally accepted auditing standards in Sweden will always detect actions or omissions that can give rise to liability to the company, or that the proposed appropriations of the company's profit or loss are not in accordance with the Companies Act.

As part of an audit in accordance with generally accepted auditing standards in Sweden, I exercise professional judgment and maintain professional skepticism throughout the audit. The examination of the administration and the proposed appropriations of the company's profit or loss is based primarily on the audit of the accounts. Additional audit procedures performed are based on my professional judgment with starting point in risk and materiality. This means that I focus the examination on such actions, areas and relationships that are material for the operations and where deviations and violations would have particular importance for the company's situation. I examine and test decisions undertaken, support for decisions, actions taken and other circumstances that are relevant to my opinion concerning discharge from liability. As a basis for my opinion on the Board of Directors' proposed appropriations of the company's profit or loss, I examined whether the proposal is in accordance with the Companies Act.

Mats-Åke Andersson, AB Auditoriet, Järnåkravägen 3, 222 25 Lund, appointed Auditor of Immunovia AB by the Annual General Meeting on April 26, 2019 and has been the Company's auditor since April 26, 2019, and was previously the Chief Auditor of the company from April 2017.

Lund, March 20, 2020

Mats-Åke Andersson Authorized public accountant

Definitions

Key indicator Definition Motivation for using financial key indicator
not defined pursuant to IFRS
Net sales Revenues from goods and services
sold, and royalties received rela
ting to the main activity during
the relevant period.
Operating earnings/loss Earnings/loss before financial
items and tax.
Operating earnings/loss provides a view of the
earnings that the company's ordinary activities
have generated.
Basic and diluted
earnings per share
Earnings/loss divided by the
weighted number of shares in the
period before and after dilution
respectively.
Average number of
shares before and after
dilution
The average number of outstan
ding shares in the period before
and after dilution respectively.
Because the group is generating
a loss, there is no dilution, despite
the subscription price being lower
than the share price.
R&D expenses The company's direct expenses
for research and development.
Expenses for staff, materials and
external services.
The company's main activity is research and
development. Management considers that
R&D expenses are an important parameter
to monitor as an indicator of activity levels
within the company.
R&D expenses as a
percentage of operating
expenses
R&D expenses divided by ope
rating expenses, which include
other external expenses, person
nel expenses, depreciation and
amortization.
Management considers that the company's
R&D expenses in relation to total expenses
are an important indication of the proportion
of total expenses that are used for the
company's main activity.
Cash and cash equiva
lents
Cash and bank balances.
Cash flow from opera
ting activities
Cash flow before cash flow from
investing activities and financing
activities.
Cash flow for the period
(SEK 000)
The change in cash and cash equi
valents for the period excluding
effective unrealized exchange rate
gains and exchange rate losses.
Equity per share (SEK) Equity divided divided by the
number of shares at the end of
the period.
Management follows this indicator to monitor
the value of equity per share.
Equity/assets ratio Equity as a percentage of total
assets
Management follows this indicator of the
company's financial stability.
Average number of
employees
The average number of employ
ees is the total of working-hours
in the period divided by scheduled
working hours for the period.
Average number of
employees in R&D
The average of the number of
employees in the company's rese
arch and development functions.

Glossary

Key indicator Definition

Operating earnings/loss Earnings/loss before financial

Revenues from goods and services sold, and royalties received relating to the main activity during

the relevant period.

Earnings/loss divided by the weighted number of shares in the period before and after dilution

The average number of outstanding shares in the period before and after dilution respectively. Because the group is generating a loss, there is no dilution, despite the subscription price being lower

The company's direct expenses for research and development. Expenses for staff, materials and

R&D expenses divided by operating expenses, which include other external expenses, personnel expenses, depreciation and

Cash flow before cash flow from investing activities and financing

The change in cash and cash equivalents for the period excluding effective unrealized exchange rate gains and exchange rate losses.

Equity divided divided by the number of shares at the end of

The average number of employees is the total of working-hours in the period divided by scheduled working hours for the period.

The average of the number of employees in the company's research and development functions.

items and tax.

respectively.

than the share price.

external services.

amortization.

activities.

the period.

Equity/assets ratio Equity as a percentage of total assets

lents Cash and bank balances.

Net sales

Basic and diluted earnings per share

Average number of shares before and after

dilution

R&D expenses

R&D expenses as a percentage of operating

Cash and cash equiva-

Cash flow from operating activities

Cash flow for the period

Equity per share (SEK)

Average number of employees

Average number of employees in R&D

expenses

(SEK 000)

Motivation for using financial key indicator not defined pursuant to IFRS

Operating earnings/loss provides a view of the earnings that the company's ordinary activities

The company's main activity is research and development. Management considers that R&D expenses are an important parameter to monitor as an indicator of activity levels

Management considers that the company's R&D expenses in relation to total expenses are an important indication of the proportion of total expenses that are used for the

Management follows this indicator to monitor

Management follows this indicator of the

the value of equity per share.

company's financial stability.

have generated.

within the company.

company's main activity.

Antigen. Actionable information – Information that is sufficiently authoritative and specific to be used in clinical decision making.

Antibodies – Antibodies, or immunoglobulins, are a type of protein used by the body's immune system to detect and identify foreign substances such as viruses, bacteria or parasites.

Antigen – A foreign body substance that elicits a reaction of the immune system in contact with the organism. The substance may be a chemical substance, a protein or a carbohydrate.

Autoimmunity – Autoimmunity is the immune system's harmful attack on the body's own tissue, which can take the form of disease or rejection of organs during transplantation.

Benign – If a tumor is benign it means that the tumor is not dangerous and will not spread.

Bioinformatics – Bioinformatics is an interdisciplinary field in which algorithms are developed for the analysis of biological (especially molecular biology) data.

Biomarker – A biomarker can be defined as a biological response to a change caused by disease or foreign substance. Biomarkers can be used as early warning signs of biological changes in an organism.

Companion Diagnostics – Diagnostics tools aimed at identifying which groups of patients will respond well to a particular treatment and thus ruling out ineffective treatments.

Discovery Trial – Research carried out in order to verify a special hypothesis.

Histology – Histology is the study of biological tissue.

Invasive – Invasive means to penetrate or attack. Invasive medical examinations refer to examinations that include any form of penetration through a hole in the body or surgical operation.

Malignant – Malignant tumors tend to worsen and become mortal. They are termed cancer, and thus differ from benign tumors.

Metastasis – A metastasis is a tumor that has spread to other organs.

Microarray – A microarray is a molecular biology test format for simultaneously measuring the relative concentrations of proteins.

Molecular Diagnosis – A collection of technologies used to analyze biological markers at the genomic and protein levels (i.e., the genetic code of individuals and how their cells express their genes as proteins in the body), using molecular biology for medical testing. These technologies are used to diagnose and monitor disease, detect the risk of disease and to determine which treatment is likely to work best for the individual.

NSCLC – Non-Small Cell Lung Cancer, the most common type of lung cancer, 80-85 percent of all lung cancer cases.

Palliative care – Palliative care is administered when the patient's disease is beyond the ability to cure. The purpose of palliative care is to provide support to patients and families using both psychological and medical practices.

PanDIA-1 – Prospective trial for the diabetes risk group of patients aged over 50 recently diagnosed with type-2 diabetes.

PanFAM-1 – Prospective trial for familiar and hereditary risk groups.

Pancreatologist – Doctor specializing in diseases relating to the pancreas.

PanSYM-1 – Prospective trial for early symptom risk groups.

Prospective trial – A trial in which a group of individuals is studied and followed often for a long time to see how a particular disease develops. A prospective trial is used to study the relationship between different risk factors and a certain disease. You follow individuals with and without risk factors going forwards over time. At the end of the trial, the proportion of individuals in the two groups who developed disease is compared.

Proteomics – Proteomics is a branch of biology and includes surveys of large amounts of data about proteins.

RA – Rheumatoid arthritis, one of the most common autoimmune diseases.

RA double negative – Patients who have RA, but test negative for it using the current two single-marker standard tests, RF factor and anti-CCP.

Reproducibility – Within the field of statistics, reproducibility is described as the correlation between results from repeated measurements performed by different observers with different instruments of the same type, which measurements are performed in order to reject any measurement error due to materials and personnel.

Retrospective study – A study in which the focus is on something that has happened in the past, i.e. using historic data. This form of study starts with the answer, i.e. it is known which individuals became ill and which did not.

Screening – Screening refers to medical examinations to identify a disease. It is normally carried out before the patient has exhibited obvious symptoms.

Self-pay customers – Patients or organizations that pay without reimbursement from insurance companies or authorities.

Sensitivity – Sensitivity is a statistical measure of the reliability of a binary diagnostic test and the probability that a generated positive result is correct.

Serum – A serum is a transparent yellowish liquid obtained by allowing the blood to clot, and then removing the blood cells and the coagulation proteins. Serum contains proteins, including antibodies.

SLE (Systemic Lupus Erythematosus) – SLE is an autoimmune inflammatory disease which means that the immune system attacks the body. The symptoms come and go in cycles, sometimes the patient is sick and sometimes has no sickness at all. Usually it is the joints, skin, blood and kidneys which become inflamed, but also the nervous system, lungs and heart can be affected. The disease is currently difficult to diagnose and is often confused with other autoimmune diseases.

Specificity – Specificity is a statistical measure of the reliability of a binary diagnostic test and the probability that the generated negative result is de facto negative.

Vinnova – Vinnova is a Swedish government agency under the Ministry of Industry which aims to promote sustainable growth by improving conditions for innovation and by funding needs-driven research.

Shareholder information

Annual General Meeting 2020

The shareholders of Immunovia AB (Publ.) are called to the Annual General Meeting on May 7, 2020, at 4 pm at Medicon Village in Lund.

Registration

Shareholders who wish to attend the Annual General Meeting must be included in the register of shareholders held by Euroclear Sweden AB no later than Thursday, April 30, 2020, and must register with the company no later than Thursday, April 30, 2020.

Registration for attendence is made by mail to Immunovia AB (Publ.), Medicon Village, 223 81 Lund, Sweden, by phone +46 46 275 60 00, or by e-mail to [email protected].

The registration must include the name of the person or organization, person or organization number, number of shares, address, daytime telephone number and, if applicable, the number of assistants (maximum two) referred to at the meeting.

Shareholders who have registered their shares with a bank or other nominee must be temporarily registered in their own name in order to participate in the AGM. Such registration must be registered at Euroclear Sweden AB no later than April 30 meaning that the shareholder should notify the nominee well in advance before that date.

Financial calendar

Interim report Jan-March 2020 Tuesday April 28, 2020 Annual General Meeting 2020, Thursday May 7, 2020 Interim report Jan-June 2020, Thursday August 20, 2020 Interim report Jan-Sep 2020, Thursday November 12, 2020 Financial statement 2020, Wednesday February 17, 2021

Contact information:

Immunovia AB (Publ.), Medicon Village, Scheelevägen 2, 223 81 Lund, Sweden

Tel: +46 (0)46-2756 000 Email: [email protected] Web: www.immunovioa.com For further information please contact • Mats Grahn, CEO • e-post: [email protected] • Julie Silber, IR Director • Email: [email protected] Phone: +46(0)79 3486277

2019 Annual Report

IMMUNOVIA AB (PUBL)

Annual Report 2019

EARLY DETECTION

80

Scheelevägen 2, Medicon Village 223 81 Lund, Sweden Phone:+46 (0)46-2756 000 [email protected] www.immunovia.com

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