Immunovia Interim report, January-September 2017
“The important prospective studies for the pancreas test within the diabetes group (“PANDIA-1”) and the early symptoms group (“PANSYM-1”) have in discussions with clinical partners made progress for both PANDIA-1 and PANSYM-1. At the end of October, collection of blood samples began from patients with early symptoms at University College London Hospital. This was a very significant milestone for PANSYM-1. The retrospective, diabetes risk-group study based on the biobank from Region Skåne is also now under way.”
“We are working intensively to industrialize IMMray™ PanCan–d in order to reach the start of sales, which is our most important milestone. This involves development work and all the preparations ahead of ISO 13485 certification and other accrediting that is needed to begin selling in the US and in Europe. Preparations for the market launch and CE-marking also entail scaling up production and the laboratory processes with the same robustness and reproducibility used in the retrospective validation studies.”
“During October we have within the autoimmune efforts announced a collaboration with Linköping University in Sweden. In addition to expertise in RA, SLE, Vasculitis and Sjögren’s Syndrome, the university has valuable biobanks that cover all four diseases. All of the sample collections have now been delivered to us, and validation and complementary studies have started with our extended resources for the autoimmunity project.”
Key Indicators
| Key Indicators (SEK 000 unless otherwise stated) |
1 July-30 Sept. 2017 | 1 July-30 Sept. 2016 | 1 Jan.-30 Sept. 2017 | 1 Jan.-30 Sept. 2016 | Full year 2016 |
| Net sales | 27 | 5 | 122 | 71 | 177 |
| Operating earnings | -11,641 | -4,048 | -30,157 | -9,451 | -14,978 |
| Earnings before tax | -11,589 | -4,048 | -29,914 | -9,346 | -14,723 |
| Net earnings | -11,589 | -4,048 | -29,914 | -9,346 | -14,723 |
| Earnings per share before dilution (SEK/share) | -0.69 | -0.28 | -1.78 | -0,65 | -0,98 |
| Equity ratio, % | 97 | 97 | 97 | 97 | 98 |
| No. of shares at the end of the period | 16,804,059 | 16,474,568 | 16,804,059 | 16,474,568 | 16,804,059 |
This financial statement has been produced in accordance with IFRS for the Immunovia Group, which comprises Immunovia AB and the wholly-owned subsidiary Immunovia Inc.
Outlook*
Immunovia is focused on fundamentally transforming diagnosis of complex forms of cancer and autoimmune diseases. The antibody-based platform, IMMrayTM, is the result of 15 years of research at CREATE Health – the Center for Translational Cancer Research at Lund University, Sweden. IMMrayTM is a technology platform for the development of diagnostic tests and the company’s primary test. IMMrayTM PanCan-d is the first test in the world for early diagnosis of pancreatic cancer.
• It is planned to launch IMMrayTM PanCan-d on the American and European markets with sales to out-of-pocket customers, to start when the accreditation and production upscaling have been completed, with revenues expected to begin in 2018. In coming years Immunovia will address a market that in total is worth around SEK 35 billion.
• Immunovia sees great potential in the development of tests for other unsolved problems in cancer and autoimmune diseases via its IMMrayTM platform. The next focus area will be tests within SLE, based on the positive results announced in early 2017.
For further information, please contact:
Mats Grahn, CEO, Immunovia AB
Phone: +46 (0) 70-532 02 30
E-mail: mats.grahn@immunovia.com
About Immunovia
Immunovia AB was founded in 2007 by investigators from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden. Immunovia’s strategy is to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases such as cancer, earlier and more accurately than previously possible. Immunovia´s core technology platform, IMMray™, is based on antibody biomarker microarray analysis. The company is now performing clinical validation studies for the commercialization of IMMray™ PanCan-d that could be the first blood based test for early diagnosis of pancreatic cancer. In the beginning of 2016, the company started a program focused on autoimmune diseases diagnosis, prognosis and therapy monitoring. The first test from this program, IMMray™ SLE-d, is a biomarker signature derived for differential diagnosis of lupus, now undergoing evaluation and validation. (Source: www.immunovia.com)
This information is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above.
Immunovia’s shares (IMMNOV) are listed on Nasdaq First North in Stockholm and Wildeco is the company’s Certified Adviser. For more information, please visit www.immunovia.com.