Idogen AB Interim report
January 1 - June 30, 2021
""Tolerogenic cell therapy has the potential to improve and prolong the life of many patients with immune driven conditions and diseases. Idogen aims to play a key role in the rapid development that is taking place in the field."
Anders Karlsson, CEO
Idogen AB (publ) Corp. Reg. no. 556756-8521 www.idogen.com
Idogen AB Interim report
April 1-June 30, 2021
Second quarter (April-June 2021)
- Other operating income amounted to KSEK 1,731 (2,782)
- Operating loss was KSEK -9,514(-7,292)
- Loss for the period totaled KSEK -9,604(-7,976)
- Cash flow from operating activities was KSEK -6,135(-9,003)
- Loss per share before dilution was SEK -0.53(-0.87) Loss per share after dilution was SEK -0.53(-0.87)
Period (January-June 2021)
- Other operating income amounted to KSEK 3,409 (4,195)
- Operating loss was KSEK -20,164 (- 13,925)
- Loss for the period totaled KSEK -20,135(-14,197)
- Cash flow from operating activities was KSEK -16,087(-10,788)
- Loss per share before dilution was SEK -1.10(-2.03). Loss per share after dilution was SEK -1.10(-2.03)
Significant events in the second quarter
- Preparations for the application to start clinical trials made good progress.
- Documentation and qualification of the production process by Idogen's partner, the Radboud University Medical Center, continued.
- The COVID-19 pandemic affected work at the Radboud University Medical Center.
Significant events during the period
- 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
Significant events after the end of the period
- The European Patent Office (EPO) announced that a European patent will be granted to protect the company's tolerogenic cell therapy.
- No other significant events occurred after the end of the period that affected the results or financial position.
2 | Idogen AB Interim report January - June 2021 |
Condensed earnings and cash flow
2021 | 2020 | 2021 | 2020 | 2020 | |
(Amounts in KSEK unless otherwise stated) | 3 months | 3 months | 6 months | 6 months | 12 months |
Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Jan-Dec | |
Other operating income | 1,731 | 2,782 | 3,409 | 4,195 | 8,113 |
Operating expenses | -11,244 | -10,073 | -23,573 | -18,121 | -34,266 |
Operating loss | -9,514 | -7,292 | -20,164 | -13,925 | -26,153 |
Loss for the period after net financial items | -9,604 | -7,976 | -20,135 | -14,197 | -26,822 |
Average number of shares | 18,243,308 | 9,121,654 | 18,243,308 | 6,997,206 | 8,443,012 |
Average number of warrants | 9,371,654 | - | 9,371,654 | - | 500,890 |
Loss per share before dilution (SEK) | -0.53 | -0.87 | -1.10 | -2.03 | -3.18 |
Loss per share after dilution (SEK) | -0.53 | -0.87 | -1.10 | -2.03 | -3.18 |
Cash flow from operating activities | -6,135 | -9,003 | -16,087 | -10,778 | 28,081 |
KEY FIGURES | |||||
Working capital | 18,738 | 22,137 | 18,738 | 22,137 | 38,507 |
Acid-test ratio (%) | 238 | 249 | 238 | 249 | 482 |
Equity/assets ratio (%) | 60 | 63 | 60 | 63 | 80 |
Loss per share before dilution | -0.53 | -0.87 | -1.10 | -2.03 | -3.18 |
Average number of shares | 18,243,308 | 9,121,654 | 18,243,308 | 6,997,206 | 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.
3 | Idogen AB Interim report January - June 2021 |
CEO comment
Idogen's ambition is to develop cell therapies that make it possible to prevent the body's immune system from attacking biological agents, transplanted organs or the body's own cells or tissues. Since the key component of the company's tolerogenic cell therapy platform was upgraded in mid-2019, developments have rapidly advanced. We are now ready to file an application for the first clinical trial of our most advanced project, IDO 8. The aim is to be able to offer an entirely new type of treatment for patients suffering from severe hemophilia who develop neutralizing antibodies to their life-saving treatment with coagulation factor VIII (FVIII), something that affects one in three patients. Positive trial results would provide greater hope that this patient cohort could continue with its tested standard treatment, and reduce the need to find suitable replacement therapies. This first clinical trial will also consitute the clinical proof-of-concept for our platform technology with tolerogenic cell therapy for treatment of severe and unwanted immune reactions.
Solid preparation before the start of our first clinical trial Numerous milestones have been achieved in the development of IDO 8 in the past few years. We have contracted a world-leadingmanufacturer in the field of cell therapy, strengthened our patent protection, engaged in constructive dialog with regulatory authorities in several countries, appointed leading clinical experts as advisors for the project and completed a number of successful preclinical studies. All of this has formed the grounds for the application to commence a clinical trial that will be filed shortly.
Following the recruitment of a number of key individuals, we have now established a strong and competent organization that, together with our experienced advisors, is ready to take responsibility for continuing to drive the development program at a rapid pace. Our team has already proved itself - despite the COVID-19 pandemic; our outstanding flexibility and strong drive have enabled us to handle the challenges presented by the restrictions imposed on society. The clinical study is expected to be approved by the regulatory authorities at the end of the year.
Major advances in the validation of our manufacturing processes
Our partner for the manufacturing of tolerogenic cell therapy, Radboud University Medical Center in the Nether- lands, has made impressive contributions to the tech transfer and qualification of each process step that was carried out in 2020 and 2021. During the pandemic, Dutch
society has been faced far more stringent restrictions than what was experienced in Sweden, and local healthcare has been heavily burdened. Despite this, Radboud University Medical Center has, in close collaboration with Idogen, prepared the application to meet regulatory requirements. During this time, Professor Jolanda de Vries and her team have displayed an extremely high level of professionalism.
Interest from potential partners
An important part of Idogen's ongoing development work is to build relationships with future partners. In the second quarter, we maintained a dialog with a number of international pharmaceutical companies that have the potential to further develop and commercialize our cell therapy projects. This is an important and constant part of our work. We are currently seeing a trend of major global pharmaceutical companies adding innovative products from external companies to their project portfolios with the aim of retaining their strong market positions.
Advances for IDO 8 leading to positive results in the development of IDO T
Our development of the IDO 8 project for clinical phase has also led to advances that support that our concept that tolerogenic dendritic cells can ultimately become a platform technology for treatment of several severe conditions and diseases. The learning from the IDO 8 project can be readily transferred to the subsequent IDO T project. IDO T has the potential to become a treatment for inducing tolerance against undesirable upregulation of the immune system in connection with organ transplantations.
This creates a very interesting opportunity to treat transplant rejection. The market need is significant - 100,000 patients worldwide are undergoing kidney transplantations every year. Transplant physicians have also shown considerable interest in new treatment strategies that could reduce the need for broad immunosuppressive treatment that is currently required. A specific and individually adapted treatment is expected to result in improved long-term survival of transplanted organs and patients. We are now accelerating our development in this indication and preparing to start preclinical studies.
Tolerogenic cell therapy has the potential to improve and prolong the life of many patients with immune driven conditions and diseases. Idogen aims to play a key role in the rapid development that is taking place in the field.
Anders Karlsson
Chief Executive Officer
4 | Idogen AB Interim report January - June 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.
5 | Idogen AB Interim report January - June 2021 |
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Idogen AB published this content on 24 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 24 August 2021 09:33:05 UTC.