Idogen AB Interim report

January 1 - September 30, 2021

"The fact that we are now approaching the first clinical trial is therefore not only inspiring from the perspective that our technology will at last be evaluated in use with patients, but also entails a significantly stronger base for our business development."

Anders Karlsson, CEO

Idogen AB (publ) Corp. Reg. no. 556756-8521 www.idogen.com

Idogen AB Interim report

January 1-September 30, 2021

Third quarter (July-September 2021)

  • Other operating income amounted to KSEK 7,171 (1,968).
  • Operating loss was KSEK -5,249(-4,779).
  • Loss for the period totaled KSEK -5,191(-4,729).
  • Cash flow from operating activities was KSEK -9,029(-6,864).
  • Loss per share before dilution was SEK -0.28(-0.52) Loss per share after dilution was SEK -0.28(-0.52).

Period (January-September 2021)

  • Other operating income amounted to KSEK 10,580 (6,164).
  • Operating loss was KSEK -25,413(-18,704).
  • Loss for the period totalled KSEK -25,326(-18,925).
  • Cash flow from operating activities was KSEK -25,116(-17,653).
  • Loss per share before dilution was SEK -1.39(-2.45). Loss per share after dilution was SEK -1.39(-2.45).

Significant events in the third quarter

  • Idogen initiated new activities in order to maximize the effect of the tolerogenic cell therapy IDO 8 before the start of the first clinical trial.
  • Preparations for the submission of a clinical trial application (CTA) for the start of the planned clinical trial on patients with antibodies to their treatment of hemophilia A is expected to be submitted to the relevant authorities by the end of 2021.

Significant events during the period

  • The COVID-19 pandemic affected work at the Radboud University Medical Center.
  • Idogen appointed highly reputable scientific advisors in transplantation.
  • A Corporate Governance section was added to the Annual Report, and Idogen is now compliant with the Nasdaq listing requirements.
  • An additional payment of MSEK 3 was received from the EU's Horizon 2020 program.
  • The European Patent Office (EPO) granted a European patent to protect the company's tolerogenic cell therapy.

Significant events after the end of the period

  • Idogen generated proceeds of MSEK 9.8 after issue costs when shares were subscribed for with the support of subscription warrants (TO 4).
  • No other significant events occurred after the end of the period that affected the results or financial position.

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Idogen AB Interim report January - September 2021

Condensed earnings and cash flow

2021

2020

2021

2020

2020

(Amounts in KSEK unless otherwise stated)

3 months

3 months

9 months

9 months

12 months

Jul-Sep

Jul-Sep

Jan-Sep

Jan-Sep

Jan-Dec

Other operating income

7,171

1,968

10,580

6,164

8,113

Operating expenses

-12,419

-6,747

-35,993

-24,868

-34,266

Operating loss

-5,249

-4,779

-25,413

-18,704

-26,153

Loss for the period after net financial items

-5,191

-4,729

-25,326

-18,925

-26,822

Average number of shares

18,243,308

9,121,653

18,243,308

7,713,137

8,443,012

Average number of warrants

9,801,926

250,000

9,516,741

84,249

500,890

Loss per share before dilution (SEK)

-0.28

-0.52

-1.39

-2.45

-3.18

Loss per share after dilution (SEK)

-0.28

-0.52

-1.39

-2.45

-3.18

Cash flow from operating activities

-9,029

-6,864

-25,116

-17,653

28,081

KEY FIGURES

Working capital

13,881

17,739

13,881

17,739

38,507

Acid-test ratio (%)

249

240

249

240

482

Equity/assets ratio (%)

62

61

62

61

80

Loss per share before dilution

-0.28

-0.52

-1.39

-2.45

-3.18

Average number of shares

18,243,308

9,121,653

18,243,308

7,713,137

8,443,012

All key figures in the entire report have been restated to account for the effects of a reverse split, which means that the number of shares in preceding periods has been divided by 10.

Definitions of key figures 2021

Working capital

Total current assets (including cash and cash equivalents) less current liabilities.

Acid-test ratio

Total current assets (including cash and cash equivalents) relative to current liabilities.

Equity/assets ratio

Shareholders' equity in relation to total assets.

Profit/Loss per share before dilution

Profit after tax divided by average number of shares for the period.

Average number of shares

The average number of shares from the day when the issue is registered.

Average number of warrants

The average number of warrants from the day when the issue is registered. New warrants for employees in 2021 were registered on July 6.

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Idogen AB Interim report January - September 2021

CEO comment

Idogen's goal is to revolutionize the treatment of a range of diseases in which the body's immune system has stopped acting in the patient's best interests. We develop cell therapies that prevent the immune system from attacking biological drugs, transplanted organs or healthy cells in the body. Through our unique therapies, a small number of treatments would be able to restore a well-

balanced immune system and thereby replace lifelong and thus costly drug therapy, which can sometimes cause difficult and serious side effects.

Optimization process is now in final stage prior to first clinical trial with IDO 8

Our most advanced development project, IDO 8, is adapted for patients suffering from severe hemophilia who develop neutralizing antibodies to their life-saving treatment with coagulation factor VIII, something that affects one in three patients. Following successful establishment and scaling up of the manufacturing process at our partner, the Radboud University Medical Center in the Netherlands, extensive work was conducted to document and qualty- assure large-scale production ahead of the planned first clinical trial. In parallel with this, we continued the dialog with the relevant regulatory agencies and completed the trial protocol.

During the final phase of the production validation, we decided to utilize a possible opportunity to optimize the levels of the substance in cell therapy that the body must learn to recognize and tolerate. It is important to achieve the largest possible benefit for the patient and to maximize the effect of the treatment, work that is expected to be completed before the end of the year. Provided the necessary official approval is received, the trial can be initiated during the second quarter of 2022, and unlike most drug projects, the very first clinical trial will be conducted on precisely those patients for whom the treatment is intended.

Conversion of TO 4

Breaking new ground and developing completely new types of treatment is obviously capital-intense, and although Idogen operates its business in a highly cost- effective way, continuous focus is required to ensure the company's long-term financing until the day that we achieve a positive cash flow based on revenue from license agreements. Shortly after the end of the quarter, we announced that the exercise of series TO 4 subscription warrants had resulted in the company generating approximately MSEK 9.8 after issue costs.

Continued close cooperation with our production partners Idogen's focus is now on collaborating with our production partner in the process to optimize the IDO 8 treatment ahead of the first patient study. The advancements we have made in this, our most advanced project, are naturally also valuable for the development of our cell therapies for other medical conditions. This applies not least for IDO T which is a potential treatment for inducing tolerance against undesirable upregulation of the immune system in connection with organ transplants. We recently stepped up our level of ambition in the IDO T project and during the quarter, conducted activities that represent important steps on the route to clinical trials.

Cell and gene therapies have already revolutionized the treatment of cancer and Idogen is now taking the lead in the development of treatments for other complex medical conditions. Compared with classical drug development, a very large share of the development work on these therapies occurs in the preclinical phase. Accordingly, the interest from the global pharmaceuticals industry

is enormous for the projects that have succeeded in resolving all preclinical challenges and have reached the clinical phase. The fact that we are now approaching the first clinical trial is therefore not only inspiring from the perspective that our technology will at last be evaluated in use with patients, but also entails a significantly stronger base for our business development.

Anders Karlsson

Chief Executive Officer

4

Idogen AB Interim report January - September 2021

Idogen in brief

Idogen is a Swedish biotechnology company based in Lund. Idogen develops tolerogenic cell therapies to counteract attacks by the patient's immune system on biological agents, transplanted organs or the body's own cells or tissue. The term "tolerogenic" infers that the immune system, after treatment with Idogen's cell therapy, is assumed to be able to become tolerant to a selected disease-inducing or immunoreactive antigen.

Idogen's vision is to revolutionise the treatment of several disorders and conditions in which the body's immune system does not function as it should, and for which there is a major unmet medical need. This happens in auto- immune diseases, organ rejection after transplantation and in patients who has developed antibodies against treatment with biological drugs, e.g. factor VIII or therapeutic antibodies. Idogen's technology is based on research from Lund University.

When the immune system has become your enemy

There are many situations where the body's immune system can hurt us instead of protecting us. One example is when it causes transplant rejection. Another is when the immune system neutralises the activity of biological drugs, for example, in the treatment of hemophilia with factor VIII. Another example is autoimmune diseases - such as rheumatoid arthritis, inflammatory bowel diseases,

type 1 diabetes and multiple sclerosis (MS) - where the immune system attacks the body's own proteins or antigens.

Drugs

Idogen's tolerogenic cell therapy

Drugs

New organ

Immature dendritic cell

New organ

Virus, bacteria

Internal organs, tissues

Hostile

Tolerant

Activates - War

Peace - Tolerance

Effector T-cells

Regulatory T-cells

"warriors"

"peacemakers"

Dendritic cells control other immune system cells' recognition of, and reaction to, what belongs in the body and what is foreign. The dendritic cells that recognize bacteria or viruses activate our immune system (red) and those that recognize the body's own cells stop the body from attacking its own tissues and create tolerance (green). The goal of Idogen's cell therapy is to teach the immune system so as to counteract undesirable activation while leaving the rest of the immune system unaffected.

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Idogen AB Interim report January - September 2021

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Idogen AB published this content on 26 October 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 October 2021 07:05:04 UTC.