Idogen sharpens focus on its IDO 8 program and lowers operating expenditure

Prior to the start of the clinical trial, key opinion leaders in hemophilia suggested that the company's cell therapy may have potential to be used as a replacement for the expensive - and for patients, demanding - immune tolerance induction (ITI) treatments. A cell therapy that could reduce or eliminate inhibitors in patients who have developed antibodies of this type is clearly advantageous and could potentially be useful in a patient population that is approximately three times larger than that previously announced by the company. The commercial value may therefore be substantially greater compared to that previously assumed.

A positive outcome in the IDO 8 program, or proof of concept (PoC), would validate the technology platform. In addition to the IDO T program, the company has also identified approximately one hundred autoimmune diseases that may benefit from treatment with a tolerogenic inducing mechanism of action, and it is expected that a handful of these - specifically those whose antigens are known - could be manufactured using a similar process to that developed for the IDO 8 program.

Joakim Söderström, Chairman of the Board:
"Accelerating our efforts and focus on the IDO 8 program is a strategic choice to maximize the value of the company here and now - and over the medium term. With this aggressive strategy, the Board intends to ensure that we focus our resources fully on achieving proof of concept while enhancing the efficiency of our operations, thereby significantly lowering the company's day-to-day operating expenditure. In my capacity as the largest owner in the company, I am convinced that this is the right path to take in order to best safeguard the interests of our stakeholders. With a patient cohort of approximately 18,000 patients in the target market for IDO 8, and with preliminary estimates of a treatment cost of at least MUSD 1, the total market potential is tremendous."

Acting CEO Christina Herder comments:
"Our cell therapy could provide patients with a new and better alternative to the current induction treatment with factor VIII - immune tolerance induction, or ITI - which is an arduous and costly treatment. As a result of today's decision, we now have the possibility of focusing fully on our key IDO 8 program."

If IDO 8 demonstrates a good level of safety, tolerability and efficacy in our studies, we believe that IDO 8 will be able to capture a significant share of this market since there are currently no effective alternatives for this patient cohort."

Reduced operating expenditure

The decision to reduce the company's operating expenditure by temporarily pausing the preclinical IDO T program will - excluding the cost of the IDO 8 study - lower the company's aggregate budgeted costs by approximately 66% in 2023 compared with 2022. Once proof of concept has been achieved in the IDO 8 program, the work on IDO T can be resumed and new programs started.

The company's efficiency enhancements and shifts in priority will mean a significantly lower cost mass than it previously had.  In parallel, the company is working on applications for R&D grants: previously, the company was awarded a grant of MEUR 2.9 from the EU's Horizon 2020 framework program.

Dialogues will be initiated with trade union organizations in order to make organizational adjustments.

Idogen's third-quarter report will be released on November 25 (instead of October 18, as previously announced).

For further information, please contact:

Christina Herder, Acting CEO, Idogen AB

Tel: +46 70374 71 56

E-mail: christina.herder@idogen.com

Certified Adviser:
Vator Securities AB.

This information is information that Idogen AB is obligated to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact persons set out above on October 4, 2022 at 8:01 am CEST.

Idogen (Nasdaq First North Growth Market: IDOGEN) develops tolerogenic cell therapies to prevent the patient's immune system from attacking biological agents, transplanted organs or the body's own cells or tissue. The company's most advanced program, IDO 8 - now entering its clinical phase - is designed to restore the efficacy of hemophilia drugs in patients who have developed neutralizing antibodies. For these hemophiliac patients, there is significant medical need for restoring the clinical effects of their treatment with factor VIII. This is a unique market positioning that over the long term could replace immune tolerance induction (ITI) treatments, with significant market potential. The planned IDO 8 clinical trial will validate the company's technology platform and facilitate a range of other applications in fields such as organ transplants, IDO T and autoimmune diseases, IDO AID.More information about Idogen is available viahttps://www.idogen.com