Year-end report 1 January - 31 December 2017

FOURTH QUARTER (OCTOBER-DECEMBER 2017)

•  Other operating income amounted to KSEK 0 (0)
•  Operating loss totalled KSEK -7,289 (-4,255)
•  Loss for the period totalled KSEK -7,315 (-4,255)
•  Cash flow from operating activities was KSEK -8,250 (-3,035)
•  Loss per share before dilution was SEK 0.35 (-0.36). Loss per share after dilution was SEK 0.19 (-0.36)
•  The proposed dividend is SEK 0.00/share (0.00)
•  This fourth quarter/year-end report has been prepared in accordance with RFR 2, Accounting for Legal Entities. The report has been prepared in accordance with IAS 34, with consideration for the exceptions and additions to IFRS specified in RFR 2. The company is not included in any group, which is why IFRS-compliant financial statements are not applicable. The transition to presentation in accordance with RFR 2 has not had any effect on the balance sheet at the beginning of 2016, nor on comparative periods.
  
  

FULL-YEAR PERIOD (1 JANUARY-31 DECEMBER 2017)

•  Other operating income amounted to KSEK 0 (53)
•  Operating loss totalled KSEK -21,299 (-12,583)
•  Loss for the period totalled KSEK -21,322 (- 12,599)
•  Cash flow from operating activities was a negative KSEK -19,906 (-11,407)
•  Loss per share before dilution was SEK 1.32 (-1.22) Loss per share after dilution was SEK 0.88 (-1.03)
•  The equity/assets ratio was 90% (90).
•  At the end of the period, cash and bank balances amounted to MSEK 36.9. In addition, research funding of approximately MSEK 28 will be paid out over the next three years. 
     

SIGNIFICANT EVENTS IN THE FOURTH QUARTER 

•  The company began working with quality assurance to obtain accreditation for the manufacture of cell therapy products for clinical trials.
•  The adaptation of Idogen’s manufacturing production facilities was completed as planned in November and the facilities are compliant with clean room requirements.
•  In December, a patent was granted in the US for Idogen’s tolerogenic cell therapy technology. The new US patent provides broad protection for the company’s technology in a key strategic market.
•  At the end of 2017, Idogen’s cash and bank balances amounted to MSEK 36.9. Immediately after year-end, the EU paid out MEUR 1.2, the first portion of research funding granted by Horizon 2020 (the EU Framework Programme for Research and Innovation). This brought Idogen’s cash and cash balances to MSEK 49 at the beginning of 2018. Additional funding of MEUR 1.7 will be paid out over the next 30 months.

CEO comment

Idogen develops cell therapies to prevent the patient’s immune system from attacking biological drugs, transplanted organs or the body’s own cells or tissue. In 2017, we received several clear confirmations of the high level of innovation in our technology platform – in the face of intense competition, we were granted research funding of MEUR 2.9 from the EU, and new patents in the US, Europe and Japan.

In January, orphan drug designation was granted in the EU for our most advanced project, IDO 8, which aims to restore the effect of factor VIII therapy in haemophilia A patients. Orphan drug designation has several advantages, such as less extensive requirements for clinical trials, scientific guidance from the regulators and an extended period of market exclusivity. In addition, we have previously received valuable scientific advice from the Swedish Medical Products Agency regarding the design of a first clinical trial, which we expect to commence by the end of 2018.

Based on the successful development of our unique cell therapy concept and the positive preclinical results generated for IDO 8, we decided in May to broaden our project portfolio by commencing development of the IDO T project to prevent kidney transplant rejection. The aim is to teach the patient’s immune system to recognise and accept the transplanted organ, and reduce the need for current methods of often lifelong treatment with drugs that inhibit the functionality of the immune system. Preclinical development is ongoing with the aim of commencing a Phase I/IIa clinical trial in 2019.

In April, we secured access to adapted clean rooms for the manufacturing of our cell therapy products in accordance with current regulations for pharmaceuticals. This will give us control over all stages of the manufacturing process and may reduce lead times for upcoming clinical trials. We are expecting to receive accreditation for the manufacturing production facilities in 2018.

Like other research-intensive companies that develop new therapies, considerable investment will be required before license agreements or own sales can generate revenue for Idogen. The significant research grant we received from Horizon 2020 (the EU Framework Programme for Research and Innovation) in May and the successful issue of new shares in June have given us the financial resources to drive both IDO 8 and IDO T forward at high speed.

Cell therapy is gaining interest as novel treatment option. One indication of this is Takeda’s recent announcement regarding the intention to acquire the stem cell therapy company TiGenix for a total contract value of about SEK 5 billion. Our business model is to enter into collaborations and license agreements based on the clinical trial results in each of our projects, and therefore expect to commence the first clinical trial for IDO 8 by the end of 2018. This will be a transformational step in the development of the company.

Lars Hedbys

Chief Executive Officer

For additional information, please contact:

Lars Hedbys, CEO Idogen AB

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

This is an English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that Idogen AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 15th of February 2018.

Idogen (AktieTorget: 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. Idogen’s most advanced product candidate IDO 8 is designed for patients with severe haemophilia A who have developed anti-drug antibodies against their critical treatment with coagulation factor VIII (factor VIII). The company´s second project IDO T is developed to prevent kidney transplant rejection. The treatment is based on the patient's own cells and is expected to have a favorable safety profile and long-lasting effect. The fact that a short treatment has the potential to yield a long-lasting effect is another great advantage. Idogen is expected to initiate the first clinical trial in patients with hemophilia A at the end of 2018. For more information, visit www.idogen.com

Tags: