Idogen : Interim report Q3 2022

Idogen ABInterimreport January 1 - September 30 2022

"Currently, the company is on an exciting journey of transformation, and it is extremely gratifying to have the opportunity to provide operational leadership while on this journey."

Christina Herder, acting CEO

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

Idogen AB Interim report

January 1 - September 30, 2022

Third quarter (July - September 2022)

• Other operating income amounted to KSEK 0 (7,171).
• Operating loss was KSEK -14,343(-5,249).
• Loss for the quarter totaled KSEK -14,398(-5,191).
• Cash flow from operating activities was KSEK -9,879(-9,029).
• Loss per share before dilution was SEK -0.20(-0.28). Loss per share after dilution was SEK -0.20(-0.28).

Period (January - September 2022)

• Other operating income amounted to KSEK 159 (10,580).
• Operating loss was KSEK -36,212(-25,413).
• Loss for the quarter totaled KSEK -36,286(-25,326).
• Cash flow from operating activities was KSEK -38,111(-25,116).
• Loss per share before dilution was SEK -0.58(-1.39). Loss per share after dilution was SEK -0.58(-1.139).

Significant events in the third quarter

• Idogen brings together scientific advisors at the ISTH 2022 scientific conference in London.
• Idogen receives approval from the Norwegian Medicines Agency, NoMA, for a clinical phase 1/2a study with the IDO 8-program.
• An extraordinary general meeting of shareholders on September 6 elected Joakim Söderström as new chairman and Niklas Wallet as a new member of the Board of Directors.
• Christina Herder is appointed acting CEO after Anders Karlsson.

Significant events during the period

• Idogen submits an application for clinical trial with IDO 8 to the Norwegian Medicines Agency, NoMA.
• Idogens presented the company's tolerogenic cell therapy platform at the 5th Antigen-Specific Immune Tolerance Summit.
• Idogen enters into an agreement with Vator Securities AB regarding the assignment as Certified Adviser from May 15.
• Idogen's rights issue raise MSEK 41 after issue costs.
• Idogen receives approval from the Swedish Medical Products Agency to start its clinical phase 1/2a study for IDO 8.
• Idogen strengthens the organization with key competencies for the clinical development phase.

Significant events after the end of the period

• Idogen sharpens focus on its IDO 8 program, pauses the IDO T and IDO programs and lowers operating expenditure.
• Idogen receives after exercise of warrants 280 KSEK before costs.
• First patient enters Idogen's hemophilia study under the IDO 8 program.
• EU to disburse the remaining of the Horizon 2020 grant.
• Agneta Edberg elected as new Chairman of Idogen due to changes to the Board of Directors.
• The board of Idogen propose a rights issue at up to 38 MSEK net after cost.
• Idogen invites for an extra shareholder meeting 13 December.
• No other significant events occurred after the end of the period that affected the results or financial position.

Condensed earnings and cash flow

	2022	2021	2022	2021	2021
	3 months	3 months	9 months	9 months	12 months
(Amounts in KSEK unless otherwise stated)	Jul-Sep	Jul-Sep	Jan-Sep	Jan-Sep	Jan-Dec
Other operating income	0	7,171	159	10,580	13,915
Operating expenses	-14,343	-12,419	-36,371	-35,993	-52,880
Operating loss	-14,343	-5,249	-36,212	-25,413	-38,965
Loss for the period after net financial items	-14,398	-5,191	-36,286	-25,326	-38,854
Cash flow from operating activities	-9,879	-9,029	-38,111	-25,116	-40,190

2	Idogen AB Interim report January - September 2022

CEO comment

After more than five years of work in Idogen's boardroom,

I am pleased to have had an operational role as interim CEO since September 1. Currently, the company is on an exciting journey of transformation, and it is extremely gratifying to have the opportunity to provide operational leadership while on this journey.

In mid-October, the first patient was included in our Phase 1/2a study with our first cell therapy - ItolDC-028 - as part of the "Toler8" program for IDO 8. This is the most important milestone in the company's history. This tolerogenic cell therapy meets a significant medical need among hemophilia A patients who have developed neutralizing antibodies known as inhibitors. The first patient was included at Oslo University Hospital.

The study, which is part of our first development program, now has the opportunity to clinically validate all of our technology and demonstrate proof-of-concept for our entire platform. The purpose is primarily to demonstrate safety - tolerability for our treatment - but it also has the possibility of signaling that our cell therapy has the desired clinical efficacy. We will report the results from the study on a regular basis, since it is an open study, meaning there is no control arm.

Taking the step into the clinical phase, which is an important milestone for the company, also initiated a more focused strategy with a clear priority for our IDO 8 spearhead program and the first cell therapy produced, ItolDC-028. IDO T and IDO AID, the two programs in an earlier phase

of development, have therefore been put on hold while awaiting clinical validation as part of the IDO 8 program. Accordingly, we have increased cost efficiency by drastically reducing our fixed costs and prioritizing our clinical study. This has also meant a number of organizational changes, with a reduction in the number of employees.

But it is important to point out that the potential of - and thereby the interest in - our technology platform in a range of other areas of application such as transplantation and autoimmune diseases remains.

Being in the clinical phase and obtaining data from the patients treated also facilitates a more focused dialogue with potential partners.

During the period, we also received the final payment under the EU funding program, which we were awarded in 2017 in the midst of fierce competition. Project reports have been submitted on a regular basis, and the final of these was presented this past summer. We now once again have the possibility of applying for grants from other EU programs in 2023.

Additional funding will be needed to continue with the IDO 8 development program. We have therefore started the process of raising capital, which could generate proceeds of up to MSEK 38 net after costs. We hope that current and new shareholders will want to take part in our program, where there is significant medical need among patients.

Last, but not least, it is gratifying to also have published our first article on our new cell therapy. During the period, a "letter to the editor" about our cell therapy in hemophilia was published online in Hemophilia, the prestigious scientific journal. The efforts with our clinical experts prior to the article also show that there is significant market potential for our ItolDC-028 cell therapy. We are working on following up our initial publication with several scientific articles in the near future.

The company is now entering a new era, and we need to increase our visibility and presence at scientific and clinical conferences as a stage in our development strategy.

We have a truly exciting future ahead of us!

Christina Herder

Acting CEO

3	Idogen AB Interim report January - September 2022

When the body's immune system attacks factor VIII, a critical medication

IDO 8 - Idogen's clinical program

The purpose of the IDO 8 program is to develop a tolerogenic cell therapy for patients with hemophilia who have developed antibodies to their standard substitution treatment with factor VIII. The first patient in Idogen's clinical study with the ItolDc-028 cell therapy was included on October 13, 2022. The study plans to recruit a total of nine patients and could be carried out in up to five different countries both within and outside the EU. These patients have a significant medical need, and the treatment is based on a well-defined antigen (factor VIII), which in technical terms means that there are substantial possibilities for developing a successful treatment. Idogen's treatment has the potential to make it possible for the patient to return to treatment with factor VIII.

Hemophilia A is a rare disease and Idogen has been granted orphan drug designation for the treatment in Europe.

The patient's own cells are used to manufacture the cell treatment. Precursor cells from the patient are treated with three different substances - Idogen's tolerance inducers - to create a tolerogenic dendritic cell. The cells are subsequently introduced for the antigen that is specific to the adverse immunological reaction.

The company has a license agreement with Radboud University Medical Center (RUMC) in the Netherlands for the manufacture of the company's cell therapy in accordance with Good Manufacturing Practices. RUMC has 20 years of experience in manufacturing cell therapies based specifically on dendritic cells. After manufacture, the treatment is sent back to the hospital to be administered to the patient as an intravenous injection.

		Leukapheresis							Follow-up Visits
Weeks -8	-4	0	1	2	6	12	20	22	26
Screening Baseline	ItoIDC-028									FVIII
				Administration									Challenge

IDO T and IDO AID - Idogen's preclinical possibilities

It is expected that Idogen's platform technology can be used in additional areas. One example is IDO T, where the purpose is to develop a cell therapy for patients who are receiving kidney transplants. The intent is to "teach" the immune system to recognize and tolerate the new, transplanted organ so that it is not rejected. This could reduce or eliminate entirely the need for current often lifelong treatments with immunosuppressive drugs that unselectively suppress the immune defense and thereby give rise to adverse side effects.

Another example is IDO AID, where the company's technology could be used in a group of autoimmune diseases with significant medical need. Idogen's cell therapy has the potential to better treat the cause of the autoimmune disease.

Development of both IDO T and IDO AID has been temporarily put on hold since the company has chosen to focus on IDO 8 in the clinical phase.

4	Idogen AB Interim report January - September 2022

Idogen in brief

Idogen is a Swedish biotechnology company based in Lund. Idogen works on develops tolerogenic cell therapies to counteract attacks by the patient's immune system on targets such as biological agents, transplanted organs or the body's own cells or tissue. The term "tolerogenic" comes from the fact that the purpose of treatment with Idogen's cell therapies is to selectively achieve tolerance for one or more selected pathogenic or immunostimulatory antigens.

Idogen's vision is to revolutionize the treatment of a range of diseases and conditions in the event of unwanted activation of the body's immune system. The company has identified significant medical need among patients who have developed antibodies against their treatment with biological agents such as Factor VIII or therapeutic antibodies, for organ rejection after transplantation, and for

the treatment of autoimmune diseases. Idogen's ambition is to be the first company to develop a tolerogenic cell therapy with long-lasting effects for the treatment of patients with major unmet medical needs.

Idogen's business concept for IDO 8 is to sign license agreements, or similar agreements, with major pharmaceutical companies based on the clinical results that will be received from the study that is currently in progress. The intent is for the licensee to be responsible for the final phase of development as well as the market launch.

For the IDO T and IDO AID preclinical programs, the company intends to continually review and evaluate various ways of using these programs to created the best value possible for patients and shareholders.

PROGRAM	CELL THERAPY	INDICATION	Discovery	Preclinical	GMP process	CTA approved	Phase 1/2a	Pivotal
Phase 2b/3
IDO 8	ItolDC-028	Hemophilia A with inhibitors
IDO T	ItolDC-01T	Living Donor Kidney Transplant
IDO AID	Various	Autoimmune diseases

Idogen's technology

Idogen's concept is built on developing innovative cell therapies based on tolerogenic dendritic cells, a type of white blood cell that plays a central role in our immune system, because these cells control other immune system cells' recognition of what belongs in the body (self)

and what is foreign (non-self). When we are exposed to bacteria or viruses, the dendritic cells activate our immune system. At the same time, they ensure that the immune system does not react to our own cells, for example. The dendritic cells that prevent the activation of the immune system from attacking the body's own, healthy cells are called tolerogenic.

The company treats cells from the patient's own blood outside of the body using a unique, patented method, thereby developing patient- and antigen-specific tolero- genic dendritic cells. The treated cells are subsequently reintroduced into the patient, where the tolerogenic dendritic cells prevent the specific adverse activation of the immune system without affecting everything else.

Through small changes in the manufacturing process, Idogen's technology platform can be adapted for the treatment of different diseases and conditions.

The treatment method itself is based on a combination of three different substances that by themselves have a limited effect, but together yield a synergistically powerful inductive effect. An initial patent application for the entire platform was filed in December 2019. One year later,

in December 2020, the final international application (PCT) was filed. If granted, the patent will provide market exclusivity until 2040. There is also the possibility of patent extensions in certain territories, under certain conditions.

The manufacture itself of the cell therapy in the ongoing clinical study is being handled by the company's partner, Radboud University Medical Center (RUMC) in Nijmegen in the Netherlands. RUMC is an internationally renowned academic center and a world leader in knowledge of dendritic cells.

5	Idogen AB Interim report January - September 2022