Immunovia Interim Report January-September 2018

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Nov 07, 2018, 02:59 ET

STOCKHOLM, Nov. 7, 2018 /PRNewswire/ -- Immunovia's IMMray™ platform for blood-based biomarker signatures offers exciting new opportunities to develop accurate diagnostic tests that can detect diseases at an early stage. During the period we presented new results and identified no fewer than two new areas for strategic focus in our ongoing development activities – non-small cell lung cancer and Rheumatoid Arthritis (RA).

In August we presented the results from our first collaboration trial with a global, top-ten pharmaceutical business. The results showed that Immunovia's blood-based IMMray™ biomarker array produced very high accuracy in the diagnosis of non-small cell lung cancer. Later in August we presented the results from the latest of three completed studies within autoimmune testing. The studies represented a breakthrough, showing that IMMray™ can also have significance in the diagnosis of autoimmune rheumatoid diseases. As a consequence of the trial's exceptionally good results, we have decided to make Rheumatoid Arthritis (RA) a strategic focus area within autoimmunity.

These results for new applications clearly indicate the broad usability of the IMMray™ platform for addressing a large amount of unsolved problems within the fields of cancer, autoimmunity and other complex diseases. This means there is an opening for IMMray™ becoming a significant platform in global diagnostics for the future.

As reported at the start of the quarter, new data has emerged showing that optimization of IMMray™ PanCan –d is required before the product can be launched on the market. This means a delay in the sales start until the latter part of 2019. Work on IMMray™ PanCan –d has continued during the quarter with undiminished intensity in the face of these new circumstances.

Immunovia's financial targets were updated before the previous interim report and remain in place.

- Mats Grahn, CEO of Immunovia AB

Key indicatiors

Key indicators (SEK thousand unless otherwise stated)	1 July–30 Sept. 2018	1 July–30 Sept. 2017	1 Jan.-30 Sept. 2018	1 Jan.-30 Sept. 2017	Full year 2017
Net sales	85	27	241	122	149
Operating earnings	– 17,344	– 11,641	– 61,952	– 30,157	– 45,520
Earnings before tax	– 17,403	– 11,589	– 60,876	– 29,914	– 45,232
Net earnings	– 17,403	– 11,589	– 60,883	– 29,914	– 45,232
Earnings per share before and after dilution (SEK/share)	– 0.89	– 0.69	– 3.34	– 1.78	– 2.67
Equity ratio, %	97	97	97	97	94
No. of shares at the end of the period	19,531,353	17,318,059	19,531,353	17,318,059	17,318,059
Average no. of shares before and after dilution	19,487,025	16,804,059	18,212,275	16,804,059	16,932,559

This financial statement has been produced in accordance with IFRS for the Immunovia Group, which comprises Immunovia AB and the wholly-owned subsidiaries, Immunovia Inc and Immunovia GmbH.

Outlook

Immunovia is focused on fundamentally transforming diagnosis of complex forms of cancer and autoimmune diseases. The antibody-based platform, IMMray™, is the result of 15 years of research at CREATE Health – the Center for Translational Cancer Research at Lund University, Sweden. IMMray™ is a technology platform for the development of diagnostic tests and the company's primary test, IMMray™ PanCan –d, is the first test in the world for early diagnosis of pancreatic cancer.

The company's financial targets remain in place from the previous quarter. The company expects to receive the first revenues from self-pay sales in the latter part of 2019. The following financial targets have been established:

• Immunovia's target is to achieve turnover of SEK 250-300 million by 2022 based on self-pay for IMMray™ PanCan –d.

• Immunovia's target is to achieve total turnover, including payment via self-pay and cost remuneration from insurance systems, of SEK 800-1,000 million by 2024.

For more information, please contact:

Mats Grahn

Chief Executive Officer, CEO, Immunovia

Tel.: +46-70-5320230

Email: [email protected]

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. (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 Stockholm. For more information, please visit www.immunovia.com.

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Immunovia Q3 2018 Eng

SOURCE Immunovia AB