Idogen appoints Anders Karlsson as new CEO

REGULATORY


Idogen AB (”Idogen”) announces today that Anders Karlsson has been appointed new CEO for the company. He will take up his new position on August 19, 2019.

Anders Karlsson has a broad experience from a range of pharma and medtech companies, including leading positions at Novartis and Olerup International. Most recently, Anders Karlsson served as CEO of Allenex AB where he managed the merger with CareDx Inc. In his previous positions, he has successfully re-positioned companies and negotiated global cooperation agreements.

”We are very pleased with the recruitment of Anders Karlsson. His combined experience from both the pharma and medtech industries, and renowned management skills, will be of great value for Idogen. Anders has a strong business acumen and has contributed to significant value creation on multiple occasions in his previous roles. The Board of Directors look forward to continue the development of Idogen together with Anders,” comments Idogen’s chairman Agneta Edberg.

”Idogen has ground-breaking development projects within immunology and transplantation, areas which I have worked actively with over the years and where I see tremendous potential. Idogen’s product pipeline can develop into lifesaving treatments for many severely ill patients in the future. With its skilled employees, the company is well positioned for value creation in the coming years and I look forward to lead the company through that journey”, says Anders Karlsson, incoming CEO of Idogen.


For additional information, please contact:

Agneta Edberg, Chairman of the Board, Idogen AB

Tel: +46 (0)70 555 75 18

E-mail: edberg.agneta@gmail.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 15 July 2019.


Idogen (Spotlight Stock 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. 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. In a third project, IDO AID, Idogen focuses on the treatment of autoimmune diseases. 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.
For more information, visit https://www.idogen.com 

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Idogen has successfully established a novel method for the company’s cell therapy

REGULATORY

Idogen AB (“Idogen”) announces today that the company has successfully established a novel method for the preparation of their tolerogenic cell therapy. In January 2019 an evaluation of a number of new potential methods in an improved analysis model was initiated, which makes it possible to assess the tolerogenic effect on human immune cells in the laboratory with improved precision. This extensive work has now been completed with very good results.

Idogen’s tolerogenic cell therapy is based on dendritic cells, a type of white blood cells that plays a central role in the immune defence because they control the behaviour of other immune cells towards endogenous (self) and foreign molecules.  

Idogen announced in January 2019 that analyses performed in a scientifically improved evaluation model showed that the company’s technology so far, based on zebularine as an tolerance inducer, did not give the effect that earlier preclinical experiments had indicated. Therefore, a comprehensive systematic evaluation of a number of alternative tolerance inducers was initiated in order to identify a more effective method to generate dendritic cells that educates the body to tolerate drugs, endogenous molecules and cells. This work has led to the establishment of a new method for the development of the company’s cell therapy projects in the areas of hemophilia (IDO 8), kidney transplant (IDO T) and autoimmune diseases (IDO AID). The new method is based on a carefully selected combination of tolerance inducing substances that will replace zebularine.

Idogen is now continuing the preparation of the company’s tolerogenic cell therapy based on the new method. The next important sub target is to initiate a clinical study of IDO 8 in hemophilia patients who have developed immunity against their treatment.

Based on the positive result from an initial intellectual property assessment, Idogen has started work on compiling patent applications for the new method.

“The success of our systematic evaluation work means that we have been able to establish a significantly stronger method for the preparation of our tolerogenic cell therapy. The last few months have been a test of strength for the company’s employees and with the promising results achieved we can now look back on our efforts with pride. We are now continuing the development of our projects at a fast pace”, says Idogen’s CEO, Lars Hedbys.
 

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 18 June 2019

Idogen (Spotlight Stock 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. 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. In a third project, IDO AID, Idogen focuses on the treatment of autoimmune diseases. 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. For more information, visit https://www.idogen.com

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Idogen AB publishes Annual report for 2018

REGULATORY

For additional information, please contact:

Lars Hedbys, CEO Idogen AB

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

E-mail: lars.hedbys@idogen.com
The information was submitted for publication through the above contact person on May 29 2019

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Idogen demonstrates proof-of-principle in a model of autoimmune disease

REGULATORY


Idogen has, as previously announced, decided to evaluate the potential of the company’s technology in a group of autoimmune diseases where there is a high unmet medical need and where the treatment could be granted orphan drug designation. The company has now successfully completed a pre-clinical study in a model of autoimmune uveitis, a serious disease which can lead to blindness.

In the model of induced autoimmune uveitis, groups of animals were treated with zebularine by injection. The group of animals treated with zebularine showed a significant positive effect in symptom relief compared with the control group of untreated animals. The model is T cell driven and the effect of zebularine is therefore expected to be relevant to the treatment of additional autoimmune diseases.

“This study is an important step in the evaluation of a number of autoimmune diseases that we are now conducting and it is positive that we are able to achieve these results. The results represent an important piece of the puzzle in our analysis and will be compared with the additional work that is carried out in other autoimmune diseases and with other methods of administration” – CEO Lars Hedbys comments.


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 28th of November 2018.


Idogen (Spotlight Stock 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. 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. In a third project, IDO AID, Idogen focuses on the treatment of autoimmune diseases. 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. For more information, visit https://www.idogen.com

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Interim report 1 January – 30 September 2018

REGULATORY

Interim report 1 January-30 September 2018


THIRD QUARTER (JULY-SEPTEMBER 2018)

  • Net turnover amounted to KSEK 0 (0)
  • Operating loss totalled KSEK -7,268 (-6,075)
  • Loss for the period totalled KSEK -7,318 (-6,068)
  • Cash flow from operating activities was KSEK -6,860 (-7,510)
  • Loss per share before dilution was SEK -0.35 (-0.31). Loss per share after dilution was SEK -0.25 (-0.18)


PERIOD (JANUARY-SEPTEMBER 2018)

  • Net turnover amounted to KSEK 0 (0)
  • Operating loss totalled KSEK -23,065 (-14,010)
  • Loss for the period totalled KSEK -22,828 (-14,007)
  • Cash flow from operating activities was KSEK -9,961 (-11,657)
  • Loss per share before dilution was SEK -1.10 (-0.95). Loss per share after dilution was SEK -0.68 (-0.72)

     
     

SIGNIFICANT EVENTS IN THE THIRD QUARTER

  • In August, the Board decided to add a third therapeutic area to Idogen’s project portfolio – autoimmune diseases, IDO AID.
  • In September, Idogen’s IDO 8 was granted orphan drug designation in the US.

SIGNIFICANT EVENTS DURING THE PERIOD

  • In January, the EU paid the first portion of the Horizon 2020 research funding, an amount of MEUR 1.2. Additional funding of MEUR 1.7 will be paid out over the next 24 months.
  • In April, Idogen announced that the company had postponed the planned start of the Phase I/IIa clinical trial of the IDO 8 project until early 2020 and initiated an expanded optimisation process. Accordingly, the planned start of the first clinical trial in the IDO T project was also postponed until the end of 2020 at the earliest.
  • Idogen strengthened its research organisation in the second quarter with the appointment of Hanne Risager Romedahl as new Chief Scientific Officer. Hanne took up her position on 7 May and replaces Anette Sundstedt who has remained with the company in the role of scientific expert.

SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD

  • The Board of Idogen will convene an Extraordinary General Meeting on November 5 to resolve on a rights issue. The rights issue will raise MSEK 60.6 and is guaranteed to 80 %. Idogen will receive net between MSEK 37.5 and 48.5 after new issue costs.
  • The Board has decided to apply for listing on Nasdaq First North with the aim of being listed on First North Premier as soon as the terms are met.
  • No other significant events occurred after the end of the period that affected the results or financial position.


CONDENSED EARNINGS AND CASH FLOW

(Amounts in KSEK unless otherwise   stated)  2018  2017  2018  2017  2017 
3   months  3   months  6   months  6   months  12   months 
Jul-Sep  Jul-Sep  Jan-Sep  Jan-Sep  Jan-Dec 
Net sales 0  0  0  0 
Operating expenses -7,268  -6,075  -23,065  -14,010  -21,299 
Operating loss -7,268  -6,075  -23,065  -14,010  -21,299 
Loss for the period after net financial items -7,318  -6,068  -22,828  -14   007  -21,322 
Average number of shares 20,781,790  19,476,485  20,779,833  14,667,123  16,207,516 
Average number of warrants 8,555,883  14,507,802  12,880,835  4,889,076  7,969,864 
Loss per share before dilution (SEK) -0.35  -0.31  -1.10  -0.95  -1.32 
Loss per share after dilution (SEK) -0.35  -0.31  -1.10  -0.95  -1.32 
Cash flow from operating activities -6,860  -7,510  -9,961  -11,657  -19,906 

KEY   FIGURES
 
Working capital 8,532  43,836  8,532  43,836  33,894 
Acid-test ratio (%) 151  981  151  981  895 
Equity/assets ratio (%) 51  90  51  90  90 
Loss per share before dilution -0.35  -0.31  -1.10  -0.95  -1.32 
Average number of shares 20,781,790  19,476,485  20,779,833  14,667,123  16,207,516 

Definitions of Key Figures

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 balance sheet total.

Earnings per share before dilution
Profit after tax divided by the average number of shares for the period.

Average number of shares
The average number of shares on the day when the new issue is registered. 

This is an English version of the original Swedish report communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This information is such that Idogen AB is obligated to publish under the EU Market Abuse Regulation (MAR) and the Swedish Securities Market Act. The information was submitted for publication, through the agency of the contact person set out above, on October 23 2018. 

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Idogen’s investor events in October-November 2018

During October and November 2018, Idogen AB’s (“Idogen”) CEO Lars Hedbys will present the company at several investor events. New and future shareholders are warmly welcomed to the events. For more information, see below. BioStock Life Science Summit in Lund, October 25 Time: Thursday October 25 2018, at 13:25-13:45 Location: Medicon Village, Lund Organizer: BioStock, […]

The Canadian Intellectual Property Office intends to grant Idogen’s patent application for tolerogenic cell therapy

REGULATORY

The Canadian Intellectual Property Office (”CIPO”) has communicated its intention to grant Idogen’s Patent Application No. 2,822,745. The patent belongs to Idogen’s second patent family and covers Idogen’s technology for induction of IDO for the treatment of autoimmune diseases and transplant rejection. Once the issue fee is paid by Idogen and necessary formalities have been completed by CIPO, the patent will be granted. The patent term will then extend to December 2031, potentially longer if an application for supplementary protection is filed and is granted.

Patents from this patent family were granted during 2017 in USA, Europe and Japan. The Canadian patent, when granted, will complement the granted patents in this family and an earlier European Patent in Idogen’s first patent family, granted in December 2013.  

This patent provides very important protection for our tolerogenic cell therapy in Canada, the 10th largest pharmaceutical market globally and an important territory for innovative therapies such as ours. This patent family covers key components of our technology, together with its use and its products, Idogen´s CEO Lars Hedbys comments.


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 4th of October 2018.


Idogen (Spotlight Stock 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. 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. In a third project, IDO AID, Idogen focuses on the treatment of autoimmune diseases. 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. For more information, visit https://www.idogen.com 

Attached file

Idogen’s IDO 8 granted orphan drug designation in the USA

REGULATORY

Idogen has previously been granted orphan drug designation in the EU for IDO 8. This is now being complemented with the grant in the United States, a significant progress for the company. 

IDO 8 is Idogen’s most advanced project, aimed at developing a tolerogenic cell therapy for patients with severe haemophilia who have developed inhibitory antibodies against their regular treatment. Idogen´s cell therapy has potential to restore the original efficacy of factor VIII treatment. 

“The orphan drug designation in the United States means that we now receive support from the FDA during the development work and seven years of market exclusivity after launch. This facilitates further development and potential commercialization of our cell therapy, which targets a well-defined group of hemophilia patients in great need of improved treatment”, Idogen´s CEO Lars Hedbys comments. 


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 26th of September 2018.


Idogen (Spotlight Stock 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. 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. For more information, visit https://www.idogen.com 

Attached file

Idogen AB Interim report January – June 2018

REGULATORY

Interim report January 1 – June 30 2018

SECOND QUARTER (APRIL – JUNE 2018) 

  •  Other operating income amounted to KSEK 0 (0)
  •  Operating loss totalled KSEK -8,689 (-4,659)
  •  Loss for the period totalled KSEK -8,669 (-4,662)
  •  Cash flow from operating activities was KSEK -7,896 (-1,412)
  •  Loss per share before dilution was SEK -0.42 (-0.38). Loss per share after dilution was SEK -0.26 (-0.38)

PERIOD (JANUARY – JUNE 2018) 

  •  Other operating income amounted to KSEK 0 (0)
  •  Operating loss totalled KSEK -15,797 (-7,935)
  •  Loss for the period totalled KSEK -15,510 (-7,939)
  •  Cash flow from operating activities was KSEK -3,102 (-4,146)
  •  Loss per share before dilution was SEK -0.75 (-0.65). Loss per share after dilution was SEK -0.41 (-0.65) 

SIGNIFICANT EVENTS IN SECOND QUARTER 

  •  In April, Idogen announced that the company had postponed the planned start of the Phase I/IIa clinical trial of the IDO 8 project until early 2020 and initiated an expanded optimisation process. Accordingly, the planned start of the first clinical trial in the IDO T project was also postponed to the end of 2020 at the earliest.  
  •  Idogen strengthened its research organisation in the second quarter by appointing Hanne Risager Romedahl as new Chief Scientific Officer. Hanne took up her new position on 7 May and replaces Anette Sundstedt who remains with the company in the role of scientific expert.  
  •  The Annual General Meeting re-elected Agneta Edberg Chairman of the Board, and Leif G Salford, Christina Herder and Karin Hoogendoorn members of the Board.
  •  The TO2 redemption period fell during the quarter and resulted in KSEK 20.

SIGNIFICANT EVENTS DURING THE PERIOD 

  •  In January, the EU paid out the first portion of the Horizon 2020 research funding, an amount of MEUR 1.2. Additional funding of MEUR 1.7 will be paid out over the next 24 months.
  •  Idogen’s research unit was relocated from the Lund Biomedical Centre to Medicon Village in Lund.

SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD 

  •  In August, the Board decided to extend Idogen’s project portfolio to a third area in the field of autoimmune diseases. 
  •  No other significant events affecting the company’s earnings or financial position occurred after the end of the period.


CONDENSED EARNINGS AND CASH FLOW
 

Attached file

Idogen extends the project portfolio to projects in autoimmune diseases

REGULATORY

Idogen´s technology is designed for the development of tolerogenic cell therapy in a variety of areas, especially treatment of anti-drug antibodies, autoimmune diseases and organ rejection after transplantation.

Until now, Idogen’s project portfolio consisted of the two product candidates IDO 8 and IDO T. IDO 8 is aimed at patients with severe haemophilia A affected by inhibitory antibodies against their vital treatment with coagulation factor VIII. An initial clinical trial of IDO 8 is scheduled to start in early 2020. IDO T is a treatment method aimed at preventing organ rejection in transplantation, primarily in renal transplantation. Preclinical proof of concept data for IDO T is expected to be presented within three to six months.

Idogen has now decided to expand the project portfolio with a third therapeutic area; autoimmune diseases. Patients with autoimmune diseases are often treated for prolonged periods with drugs that strongly suppress the immune system. However, the effect on the underlying disease is rarely optimal and treatment can lead to unwanted side effects. The medical need for improved therapies is therefore large. The purpose of Idogen’s tolerogenic cell therapy is to dramatically reduce the need for immunosuppressive drugs by a short treatment with improvements for the patient as a result. Proof of principle data from a preclinical trial model relevant to a rare autoimmune disease is expected to be presented within three to six months.

“We are very excited about the opportunity to evaluate the potential of Idogen’s technology platform in the field of autoimmune diseases. Today, there is a major unmet medical need in patients with current standard treatments, where we believe that Idogen’s tolerogenic cell therapy can play an important role. Our focus will be on one or several rare diseases, which allows for the grant of orphan drug designation that can reduce both development costs and time until market approval, as well as extended market exclusivity”, CEO Lars Hedbys comments. 

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 August 17 2018.

Idogen (Spotlight Stock 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. 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. For more information, visit https://www.idogen.com 

Attached file