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Immunovia
Quarterly Report • Feb 14, 2020
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Quarterly Report
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1 Full Year Report 2019
IMMUNOVIA AB (PUBL)
Full Year Report 2019
Key indicators
| 2019 | 2018 | Full year | Full year | |
|---|---|---|---|---|
| SEK thousand unless otherwise stated | Oct-Dec | Oct-Dec | 2019 | 2018 |
| Net sales | 45 | 91 | 356 | 333 |
| Operating earnings | -29,584 | -25,756 | -114,248 | -87,708 |
| Earnings before tax | -32,616 | -25,655 | -114,517 | -86,531 |
| Net earnings | -32,616 | -25,655 | -114,521 | -86,538 |
| Earnings per share before dilution (SEK | -1.66 | -1.31 | -5.85 | -4.67 |
| Earnings per share before after dilution (SEK) | -1.66 | -1.31 | -5.85 | -4.67 |
| Equity ratio (%) | 85 | 97 | 85 | 97 |
| Number of shares at the end of the period | 19,654,853 | 19,531,353 | 19,654,853 | 19,531,353 |
Significant events in Q4
Immunovia announced that the commercialization of IMMray™ PanCan-d is proceeding according to plan.
Results from "Commercial Test Model" study were successful, confirming the unique ability of the IMMray™ PanCan-d test to enable earlier detection of pancreatic cancer through a simple blood test.
The scientific results that are summarized by IMMray™ PanCan-d in combination with the tumor marker CA 19-9 succeeding in separating the pancreatic cancer (PDAC) samples in stages I to IV from all control groups with 96% accuracy.
Furthermore, the accuracy was 95% for distinguishing PDAC in the early stages I and II, versus all control groups.
Immunovia strengthened its management team with two very experienced managers: Hans Christian Pedersen has been appointed VP Business Development and Dr. Peter Schultz-Knappe has been appointed Chief Technology Officer (CTO).
Immunovia announced that the company's second lung cancer collaboration with a global pharmaceutical partner is scheduled to be completed in Q2 2020.
Immunovia announced a collaboration with Prof. Dr. Thomas Huizinga from the Rheumatology Department at Leiden University Medical Center, one of Europe's leading rheumatoid arthritis (RA) centers. The focus of this collaboration is a retrospective study to differentiate patients with RA from control subjects who exhibit RA-like symptoms but do not have RA, reflecting the unresolved clinical need where such a test would be used.
Significant events after the period's end
Immunovia strengthened its management with
Michael Pettigrew, the new SVP Sales North America for the IMMray ™ PanCan-d launch.
About the report • This information was submitted for publication February 14, 2020, at 8.00 am.
• This financial statement has been produced in accordance with IFRS for the Immunovia • Group, which comprises
Immunovia AB and the wholly-owned subsidiaries Immunovia Incentive AB, Immunovia Inc. and Immunovia GmbH.
EARLY DETECTION Contact Immunovia AB (publ), Medicon Village, Scheelevägen 2, 223 81 Lund, Sweden • 046-2756 000 • [email protected] For further information please contact Julie Silber, Director of Investor Relations • [email protected]
ceo's statement
Commercialization proceeding according to plan for the first test for early detection of pancreatic cancer
I am incredibly proud of the progress we made during 2019, especially in reaching the important milestone in December 2019 where we showed 95% accuracy for the upcoming commercial IMMray™ PanCan-d in diagnosing pancreatic cancer at a stage where it can still be operated on. This result opens the way for a significant improvement in care and an improved survival rate for patients suffering from this deadly disease. At Immunovia, we remain focused on introducing our blood-based test to the market in Q3 2020.
As we close 2019, we continue to make great strides and remain on-track to launch our lead diagnostic candidate IMMray™ PanCan-d in the US market during Q3 2020. We ended the year with fantastic results from the Commercial Test Model Study, which has confirmed the unique ability of our product to differentiate stages I – IV of pancreatic cancer versus clinically relevant control groups (i.e. patients with non-specific but worrying symptoms, including type II diabetes, as well as healthy subjects). In 2019, we not only achieved the milestones needed to advance towards the commercialization of IMMray™ PanCan-d, but we also made progress with our pipeline applications in lung cancer and autoimmune diseases.
Early Detection Is Crucial as Cancer Remains A Global Concern
Cancer diseases have recently surpassed cardiovascular diseases as the leading cause of death in the highly industrialized world. With the increasing global burden of cancer, the need and demand for diagnostics in the early detection of cancer is growing rapidly. Healthcare systems worldwide are transforming in order to take a more proactive approach by moving towards preventive care, early detection and personalized treatments. Regulatory authorities are implementing priority approval processes for diagnostics and new value-based payment models are being implemented.
Because pancreatic cancer is one of the deadliest cancer forms and is often diagnosed too late, early detection is vital. Each year, 338 000 people are diagnosed globally, and this number is increasing at a rapid rate. A test for early detection of pancreatic cancers, IMMray™ PanCan-d, has the potential to dramatically increase patient survival rates. Immunovia is dedicated to making early diagnosis a priority for all concerned.
Early diagnosis of cancer is an increasing need for all healthcare stakeholders. Immunovia's technology is in a position to contribute to solving these needs in the future
IMMUNOVIA AB (PUBL) Full Year Report 2019
3
Immunovia's collaboration with key stakeholders ensures awareness and helps the market introduction of IMMray™ PanCan-d
Intensified Launch Preparation
With two milestones remaining – a verification study and a final validation study – before the commercialization of IMMray™ technology in Q3 2020, we are intensifying the final launch preparations. We have successfully established a network of world renowned key opinion leaders and healthcare professionals to not only collaborate with us on how the test will be used in clinical practice, but also to supply us with the necessary blood samples, taken in the real clinical environment, to prove out IMMray™ technology. Our US team and those at the laboratory in Marlborough, MA are diligently working to implement logistics and distribution system that provides swift test results to support all our US customers. We have established a scalable sales and marketing organization which is targeting our key clinician customers at gastro centers around the US. Collaborations with patient organizations has also been a focus for us, as they play an important role in creating awareness and supporting the patients and their families.
Successful Results of Commercial Test Model Study Paves Way for Sales Start Q3 2020
As announced in a press release on December 19, 2019, our Commercial Test Model study was successful and showed an accuracy of 95%. The study was performed in order to finalize the commercial biomarker signature of IMMray™ PanCan-d and to confirm the accuracy in differentiating PDAC (pancreatic ductal adenocarcinoma) stages I - IV versus controls in the environment that best mirror the clinical and commercial setting, i.e. patients with non-specific but concerning symptoms, including type II diabetics as well as healthy individuals. The Commercial Test Model study included a total of 1,113 samples, comprising of 315 PDAC, 488 symptomatic controls, and 310 healthy individuals. All these samples were freshly collected through our Key Opinion Leaders (KOL) at seven pancreatic diseases reference sites in USA and Europe.
IMMray™ PanCan-d, in combination with CA 19-9 tumor marker, was able to detect the PDAC samples of stage I - IV vs all controls with 96% accuracy. Additionally, the accuracy for detecting PDAC early stages I and II was 95%, confirming that Immunovia's IMMray™ PanCan-d combined with CA 19-9 enables accurate early detection of pancreatic cancer through a simple blood test.
Clinical Prospective Studies Program Continue as Planned
In 2019, to validate the clinical utility for IMMray™ PanCan-d, which is important for reimbursement, Immunovia continued the three large prospective studies that covers the three main risk groups for pancreatic cancer:
- family/hereditary-PanFAM-1 study,
- new onset diabetes diagnosed after age 50, "NOD" , PanDIA-1 study,
- patients who exhibit symptoms with specific symptoms that may indicate pancreatic cancer PanSYM-1 study.
These three clinical studies, the largest studies in the world for these three risk groups, include 29 cancer centers in the US and Europe and more than 10,000 individuals. More information on www. immunovia.com..
All three studies are progressing as planned and will have final read outs in 2022/2023.
Development projects at early stages
In addition to our main focus of pancreatic cancer, Immunovia is conducting early projects in other cancers and autoimmune diseases. These are in the earlier stage of development, "Discovery Studies", where we establish KOL collaborations to gain access to expertise about the clinical need as well as high quality blood samples with clinical information representing this. These collaborations are the most important key activity for success in the studies that are crucial to the decisions to invest in the development phase, "Development Studies", which leads to a product and is a significantly greater financial commitment than the Discovery studies.
Update on Immunovia's lung cancer program:
Immunovia has made continuous progress with our two lung cancer activities. Following the initial collaborative study with a pharmaceutical company that showed very promising results, the plan is a second ongoing study which is aimed to be completed during Q2 2020.
For our own stand-alone study for early cancer detection, Immunovia began to build the network of Key Opinion Leaders (KOLs) in 2019 to provide high-quality fresh blood samples for the various test phases needed to perform in bringing a test to the market.
Update on Immunovia's Rheumatoid Arthritis (RA) Program
Immunovia has begun to build the Key Opinion Leader (KOL) network for the RA program, an instrumental activity for obtaining the fresh, high-quality blood samples as well as future key customers.
The RA program aims to test whether or not Immunovia´s IMMray™ platform can differentiate between RA patients, independent of if these test correctly for todays standard test ("anti-CCP") or incorrectly despite having RA, versus other conditions with similar symptoms like RA thus replacing the current standard CCP tests, which miss approximately 25-30% of all RA cases.
In 2019, Immunovia announced the first Key Opinion Leader (KOL) collaboration with Leiden University Medical Center's Rheumatology Department, one of the leading research centers on rheumatoid arthritis in Europe. Lieden will be providing blood samples a retrospective study and research will be led by Professor Dr. Thomas Huizinga, a world renowned KOL in RA diagnosis and research.
Process Overview: Initial Study Results to Market
Summary
In summary, the fantastic results published at the end of December 2019 has now enabled us to focus all our efforts on commercialization with sales start of the market's very first test for early diagnosis of pancreatic cancer commencing Q3 2020.
We will market IMMray™ PanCan-d first in USA and then in Europe. We continue to increase the speed of our commercialization efforts for a successful launch of IMMray™ PanCan-d. Immunovia targets an initial addressable market of \$4.4 BN USD in the US and Europe, and we look forward to working with healthcare providers around the world to improve the situation of this suffering patient group.
Finally, on behalf of the Board of Directors and the entire Immunovia team, we look forward to having a positive impact on the lives of those affected by pancreatic cancer by fulfilling the first requests in 2020 for our IMMray™ PanCan-d test for the early diagnosis of this horrendous disease.
February 14, 2020 Mats Grahn, CEO Immunovia
Table of contents
| Group's performance over the period 7 | |
|---|---|
| Share information8 | |
| Incentive scheme 10 | |
| Consolidated income statement in summary 11 | |
| Consolidated comprehensive income in summary 11 | |
| Consolidated financial position in summary 12 | |
| Change in consolidated equity in summary 13 | |
| Consolidated cash flow statement in summary 14 | |
| Consolidated key indicators 15 | |
| Definitions 16 | |
| Parent company's income statement in summary 17 | |
| Parent company's comprehensive income in summary 17 | |
| Parent company's balance sheet in summary 18 | |
| Parent company's cash flow statement in summary 19 | |
| Accounting principles 20 | |
| Glossary 24 | |
| Immunovia in brief 26 |
january-december 2019
The Group's performance over the period
Net sales
Net sales for Q4 2019 were SEK 45,000 (91,000). Sales for the period January to December 2019, amounted to SEK 356,000 (333,000). Sales consisted mainly of royalties.
During Q4 2019 capitalization of costs totaled SEK 8.1 million (5.2). Capitalization development costs are financed through approved and paid grants, and the reported amounts are reduced by a comparable amount. During 2019, grants for development costs of SEK 291,000 (2.8 m) were received.
Earnings
The net loss for Q4 2019 was SEK 32.6 million (-25.7). The loss for 2019 was SEK 114.5 million (-86.5).
The net loss for Q4 2019 was greater due to increased costs, which are mainly due to intensified market efforts ahead of the upcoming launch and that the company's prospective studies are entering a more cost-intensive phase. Other external and personnel costs rose during 2019 by a total of SEK 22.4 million compared with the corresponding period last year and amounted to SEK 132.9 million (110.5).
Research & Development
The total cost of research and development in Q4 2019 was SEK 10.7 million (5.8), which correspond to 31% (19%) of the Group´s total operating cost. The total cost of research and development for the full year 2019 was SEK 34..3 million (26.0), which correspond to 26% (23%) of the Group´s total operating cost.
Financing and cash flow
The cash flow for Q4 2019 from operating activities was SEK -22.6 million (-25.6). The corresponding cash flow for 2019 was SEK -92.0 million (-84.1).
Cash and cash equivalents as of December 31, 2019 amounted to SEK 263.3 million (386.1).
Equity was SEK 357.6 million (461.9) at the end of the period and the equity ratio is 85% (97).
In total, the number of shares and votes in Immunovia AB (publ) increased during the year by 123,500 through warrants being exercised, which brought the company SEK 10,238,000. As of December 31, 2019, there are a total of 19,654,853 shares and votes in the company.
The management believes that there is sufficient working capital to cover the working capital requirement, given the current business and development plan, for approximately 1.5 years ahead.
Investments
In Q4 2019, intangible assets were acquired for a total of SEK 9.0 million(5.9), consisting of capitalized development expenditure of SEK 8.1 million (5.2), SEK 922,000 (935,000) for patents and SEK 0 (0) for other intangible assets.
During 2019 intangible assets were acquired for a total of SEK 30.5 million (27.9) , consisting of capitalized development expenditure of SEK 28.7 million (25.1) SEK 3.9 million for patents (2.3) and SEK 0 (877,000) for other intangible assets.
Investments in tangible fixed assets in the form of inventory were made during Q4 2019 of SEK 1.1 million (403,000). For 2019, investments in tangible fixed assets were made of 6.0 million (9.1)
During Q4 the company's premises were expanded, which led to increased right of use assets of SEK 7.1 million.
No investments in financial assets were made during 2019.
Employees
The number of employees in the Group during Q4 averaged 49 (45) and at the end of the period the number of employees was 49 (45).
Share information
The number of registered shares amounted to 19,654,853 at the end of the reporting period. The share's nominal value is SEK 0.05.
Share capital's development
| Year | Event | Total share capital (SEK) |
Change (SEK) |
Total no. of shares |
Change in shares |
Nominal value (SEK) |
|---|---|---|---|---|---|---|
| May 24, 2007 | Formation | 100,000.00 | 100,000.00 | 1,000,000 | 1,000,000 | 0.10 |
| Oct 19, 2011 | New share issue | 105,263.00 | 5,263.00 | 1,052,630 | 52,630 | 0.10 |
| Oct 27, 2011 | Share split 5:1 | 105,263.00 | - | 5,263,150 | 4,210,520 | 0.02 |
| July 5, 2012 | New share issue | 108,869.92 | 3,606.92 | 5,443,496 | 180,346 | 0.02 |
| May 21, 2013 | New share issue | 122,483.76 | 13,613.84 | 6,124,188 | 680,692 | 0.02 |
| Sep 10, 2013 | New share issue | 124,899.76 | 2,416.00 | 6,244,988 | 120,800 | 0.02 |
| Jun 5, 2014 | New share issue | 220,924.32 | 96,024.56 | 11,046,216 | 4,801,228 | 0.02 |
| Aug 13, 2015 | Bonus issue | 552,310.80 | 331,386.48 | 11,046,216 | - | 0.05 |
| Dec 17, 2015 | New share issue | 714,560.80 | 162,250.00 | 14,291,216 | 3,245,000 | 0.05 |
| Sep 15, 2016 | New share issue | 823,728.40 | 109,167.60 | 16,474,568 | 2,183,352 | 0.05 |
| Oct 17, 2016 | New share issue | 840,202.95 | 16,474.55 | 16,804,059 | 329,491 | 0.05 |
| Oct 4, 2017 | New share issue via warrants |
865,902.95 | 25,700.00 | 17,318,059 | 514,000 | 0.05 |
| Jun 8, 2018 | New share issue | 974,042.65 | 108,139.70 | 19,480,853 | 2,162,794 | 0.05 |
| Sep 19, 2018 | New share issue via warrants |
976,567.65 | 2,525.00 | 19,531,353 | 50,500 | 0.05 |
| Sep 9, 2019 | New share issue via warrants |
982,742.65 | 6,175.00 | 19,654,853 | 123,500 | 0.05 |
| At end of period | 982,742.65 | 19,654,853 | 0.05 |
The 10 largest shareholders on December 31, 2019
Year Event
New share issue
New share issue
New share issue
Oct 4, 2017
Sep 19, 2018
Sep 9, 2019
Total share capital (SEK)
May 24, 2007 Formation 100,000.00 100,000.00 1,000,000 1,000,000 0.10 Oct 19, 2011 New share issue 105,263.00 5,263.00 1,052,630 52,630 0.10 Oct 27, 2011 Share split 5:1 105,263.00 - 5,263,150 4,210,520 0.02 July 5, 2012 New share issue 108,869.92 3,606.92 5,443,496 180,346 0.02 May 21, 2013 New share issue 122,483.76 13,613.84 6,124,188 680,692 0.02 Sep 10, 2013 New share issue 124,899.76 2,416.00 6,244,988 120,800 0.02 Jun 5, 2014 New share issue 220,924.32 96,024.56 11,046,216 4,801,228 0.02 Aug 13, 2015 Bonus issue 552,310.80 331,386.48 11,046,216 - 0.05 Dec 17, 2015 New share issue 714,560.80 162,250.00 14,291,216 3,245,000 0.05 Sep 15, 2016 New share issue 823,728.40 109,167.60 16,474,568 2,183,352 0.05 Oct 17, 2016 New share issue 840,202.95 16,474.55 16,804,059 329,491 0.05
Jun 8, 2018 New share issue 974,042.65 108,139.70 19,480,853 2,162,794 0.05
At end of period 982,742.65 19,654,853 0.05
Change (SEK)
via warrants 865,902.95 25,700.00 17,318,059 514,000 0.05
via warrants 976,567.65 2,525.00 19,531,353 50,500 0.05
via warrants 982,742.65 6,175.00 19,654,853 123,500 0.05
Total no. of shares
Change in shares
Nominal value (SEK)
| Shareholders | No. of shares | Share (capital and votes) |
|---|---|---|
| Carl Borrebaeck | 1,709,900 | 8.70% |
| Ålandsbanken on behalf of the owner | 1,680,839 | 8.55% |
| Handelsbanken Svenska Småbolag | 1,100,000 | 5.60% |
| Sara Andersson Ek | 888,950 | 4.52% |
| Per Mats Ohlin | 888,950 | 4.52% |
| Christer Wingren | 820,586 | 4.17% |
| Vincent Saldell | 707,183 | 3.60% |
| Försäkringsbolaget Avanza Pension | 575,334 | 2.93% |
| Swedbank Robur Folksams LO Sverige | 565,000 | 2.87% |
| Mats Grahn | 365,039 | 1.86% |
| Ten largest owners | 9,301,781 | 47.33% |
| Others | 10,353,072 | 52.67% |
| Total | 19,654,853 | 100.00% |
Incentive schemes
Immunovia has four outstanding warrant schemes that comprise 408,150 warrants with the right to subscribe for 408,150 shares. There is no dilution effect as long as the Group's earnings are negative.
The Annual General Meeting on April 26, 2019 resolved on a warrant scheme (series 2019/2023) for employees and key persons in the company. The warrants (191,000) can be used to subscribe for newly issued shares in the company during the utilization period from June 1, 2023 until June 30, 2023. Each warrant gives the right to subscribe for one share at a subscription price of SEK 342.06. Full utilization would increase the company's share capital by SEK 9,550.00.
The Annual General Meeting held on May 3, 2018 resolved to offer a warrants scheme (series 2018/2021) to employees and key persons in the company. The warrants (156,150) can be used to subscribe for newly issued shares in the company during the utilization period from September 7, 2021 to October 7, 2021. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 271.05 per share. Full utilization would increase the company's share capital by SEK 7,807.50.
The Annual General Meeting held on April 25, 2017 resolved to offer a warrants scheme (series 2017/2020) to employees and key persons in the company. The warrants (61,000) can be used to subscribe for newly issued shares in the company during the utilization period from September 15, 2020 until October 15, 2020. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 205.00 per share. Full utilization would increase the company's share capital by SEK 3,050.00.
The Annual General Meeting held on April 26, 2019 resolved to introduce an alternative cash-based incentive scheme for key individuals in countries where allocation of warrants in accordance with the 2019/2023 scheme was not applicable for various reasons. Such an incentive scheme has been introduced for employees and key individuals and is designed so that the economic effects correspond to the terms of the 2019/2023 warrants scheme. The total cost to the company can be at most USD 520,000.
The Annual General Meeting held on May 3, 2018 resolved to introduce an alternative cash-based incentive scheme for key individuals in countries where allocation of warrants in accordance with the 2018/2021 scheme was not applicable for various reasons. Such an incentive scheme has been introduced for employees and key individuals and is designed so that the economic effects correspond to the terms of the 2018/2021 warrants scheme. The total cost to the company can be at most USD 250,000.
The Annual General Meeting held on April 25, 2017 resolved to introduce an alternative cash-based incentive scheme for key individuals in countries where allocation of warrants in accordance with the 2017/2020 scheme was not applicable for various reasons. Such an incentive scheme has been introduced for emplyees and key individuals and is designed so that the economic effects correspond to the terms of the 2017/2020 options scheme. The total cost for the company can be at most USD 920,000.
The warrants are subject to customary recalculation terms in connection with share issues, etc.
Consolidated income statement, summary
| 2019 | 2018 | 2019 | 2018 | |
|---|---|---|---|---|
| SEK thousands | Oct-Dec | Oct-Dec | Full year | Full year |
| Operating income etc | ||||
| Net sales | 45 | 91 | 356 | 333 |
| Capitalized work for own account | 8,125 | 5,224 | 26,716 | 25,052 |
| Other operating income | 60 | 257 | 458 | 744 |
| Total | 8,230 | 5,572 | 27,530 | 26,129 |
| Operating expenses | ||||
| Other external expenses | -20,354 | -17,621 | -78,321 | -65,275 |
| Personnel costs | -15,289 | -12,817 | -54,576 | -45,257 |
| Amortization of tangible and | ||||
| intangible assets | -2,171 | -781 | -8,446 | -2,777 |
| Other operating expenses | 0 | -109 | -435 | -528 |
| Total operating expenses | -37,814 | -31,328 | -141,778 | -113,837 |
| Operating earnings/loss | -29,584 | -25,756 | -114,248 | -87,708 |
| Profit/loss from financial items | ||||
| Financial income | 53 | 101 | 3,820 | 1,178 |
| Financial expenses | -3,085 | 0 | -4,089 | -1 |
| Total financial items | -3,032 | 101 | -269 | 1,177 |
| Earnings/loss after financial | ||||
| items | -32,616 | -25,655 | -114,517 | -86,531 |
| Income tax | 0 | 0 | -4 | -7 |
| Earnings/loss for the period | -32,616 | -25,655 | -114 ,521 | -86,538 |
| Earnings per share before dilution (SEK) |
-1.66 | -1.31 | -5.85 | -4.67 |
| Earnings per share after dilution (SEK) |
-1.66 | -1.31 | -5.85 | -4.67 |
| Average number of shares | 19,654,853 | 19,531,353 | 19,569,089 | 18,545,795 |
| Number of shares at year's end | 19,654,853 | 19,531,353 | 19,654,853 | 19,531,353 |
Consolidated comprehensive income, summary
| 2019 | 2018 | 2019 | 2018 | |
|---|---|---|---|---|
| SEK thousands | Oct -Dec | Oct -Dec | Full year | Full year |
| Earnings/loss for the period | -32,616 | -25,655 | -114,521 | -86,538 |
| Items that may be reclassified later in the income statement |
||||
| Exchange rate differences for | ||||
| foreign net investment | 2,179 | 449 | -409 | -593 |
| Other earnings/loss for the period | 2,179 | 449 | -409 | -593 |
| Comprehensive income for the | ||||
| period | -30,437 | -25,206 | -114,930 | -87,131 |
| SEK thousands | 2019 Dec 31 |
2018 Dec 31 |
|---|---|---|
| ASSETS | ||
| Fixed assets | ||
| Intangible fixed assets | 91,860 | 61,786 |
| Tangible fixed assets 1) | 55,224 | 14,019 |
| Financial fixed assets | 3,124 | 3,008 |
| Total fixed assets | 150,208 | 78,813 |
| Current assets | ||
| Accounts receivable | 0 | 32 |
| Current receivables | 5,813 | 12,401 |
| Cash and cash equivalents | 263,345 | 386,136 |
| Total current assets | 269,158 | 398,569 |
| TOTAL ASSETS | 419,366 | 477,382 |
| EQUITY AND LIABILITIES | ||
| Equity | ||
| Share capital | 983 | 977 |
| Other contributed capital | 636,924 | 626,348 |
| Translation reserve Retained earnings incl. total comprehensive income |
-1,002 -279,301 |
-593 -164,779 |
| Total equity | 357,604 | 461,953 |
| Long-term liabilities | ||
| Interest-bearing liabilities 2) | 33,121 | 0 |
| Total long-term liabilities | 33,121 | 0 |
| Current liabilities | ||
| Interest-bearing liabilities 2) | 4,945 | 0 |
| Other liabilities | 23,696 | 15,429 |
| Total current liabilities | 28,641 | 15,429 |
| TOTAL EQUITY AND LIABILITIES | 419,366 | 477,382 |
Consolidated financial position, summary
1) Of which access rights SEK 38.5 million
2) Refers to leasing liabilities.
| SEK thousands | Share capital |
Other paid up equity |
Reserves | Accumulated earnings/loss Inc. earnings/ loss for the period |
Total equity |
|---|---|---|---|---|---|
| Opening balance January 1, 2018 | 866 | 314,170 | 0 | -78,241 | 236,795 |
| Comprehensive income for the period |
-593 | -86,538 | -87,131 | ||
| Transactions with owners in their capacity as owners |
|||||
| Deposited share warrant premiums | 936 | 936 | |||
| New share issue | 111 | 325,927 | 326,038 | ||
| Share issue costs | -14,685 | -14,685 | |||
| Closing balance Dec. 31, 2018 | 977 | 626,348 | -593 | -164,780 | 461,953 |
| Comprehensive income for the period |
-409 | -114,521 | -114,930 | ||
| Transactions with owners in their capacity as owners |
|||||
| Deposited share warrant premiums | 344 | 344 | |||
| New share issue | 6 | 10,232 | 10,238 | ||
| Closing balance Sep 30, 2019 | 983 | 636,924 | -1,002 | -279,301 | 357,604 |
Change in consolidated equity, summary
Consolidated cash flow statement, summary
| 2019 | 2018 | 2019 | 2018 | |
|---|---|---|---|---|
| SEK thousands | Oct-Dec | Oct-Dec | Full year | Full year |
| Operating activities | ||||
| Operating earnings/loss | -29,584 | -25,756 | -114,249 | -87,709 |
| Adjustment for items not included in cash flow | 2,072 | 859 | 8,444 | 2,682 |
| Interest received | 53 | 83 | 284 | 319 |
| Interest paid | -311 | 0 | -1 315 | -1 |
| Tax paid | 0 | 0 | -4 | -7 |
| Cash flow from operating activities before | ||||
| changes in working capital | -27,770 | -24,814 | -106,840 | -84,716 |
| Cash flow from changes in working capital | ||||
| Change in operating receivables | 726 | -2,515 | 6,620 | -840 |
| Change in operating liabilities | 4,399 | 1,747 | 8,266 | 1,445 |
| Cash flow from operating activities | -22,645 | -25,582 | -91,954 | -84,111 |
| Investment activities | ||||
| Investment in Intangible assets | -9,047 | -6,171 | -30,568 | -28,230 |
| Investment in tangible assets | -1,106 | -403 | -6,034 | -9,056 |
| Investment in financial fixed assets | 3 | 0 | 0 | -2 |
| Cash flow from investment activities | -10,150 | -6,574 | -36,602 | -37,288 |
| Financing activities | ||||
| Amortization of leasing liability | -1,043 | 0 | -5,115 | 0 |
| National and European grants for development | ||||
| costs | 0 | 2,718 | 291 | 2,791 |
| New share issue | 0 | 0 | 10,238 | 311,352 |
| Received warrants premiums | 28 | 28 | 344 | 936 |
| Cash flow from financing activities | -1,015 | 2,746 | 5,758 | 315,079 |
| Cash flow for the period | -33,810 | -29,410 | -122,797 | 193,680 |
| Cash and cash equivalents at start of period | 297,217 | 415,602 | 386,136 | 192,425 |
| Exchange rate difference in cash and cash equivalents |
-62 | -56 | 6 | 31 |
| Cash and cash equivalents at end of period | 263,345 | 386,136 | 263,345 | 386,136 |
Consolidated key indicators
| 2019 | 2018 | 2017 | 2016 | |
|---|---|---|---|---|
| Full year | Full year | Full year | Full year | |
| Operating earnings/loss (SEK 000) | -114,248 | -87,708 | -45,520 | -14,978 |
| Earnings/loss for the year (SEK 000) | -114,521 | -86,538 | -45,232 | -14,723 |
| Earnings per share before dilution (SEK) |
-5.85 | -4.67 | -2.67 | -0.98 |
| Earnings per share after dilution (SEK) |
-5.85 | -4.67 | -2.67 | -0.98 |
| R&D expenses (SEK 000) | -34,273 | -26,048 | -24,041 | -24,239 |
| R&D expenses as percentage of operating expenses (%) |
26 | 23 | 34 | 62 |
| Cash and cash equivalents at the period's end (SEK 000) |
263,345 | 386,136 | 192,425 | 259,094 |
| Cash flow from operating activities (SEK 000) |
-91,954 | -84,111 | -46,318 | -11,867 |
| Cash flow for the period (SEK 000) | -122,797 | 193,680 | -66,661 | 183,327 |
| Equity (SEK 000) | 357,604 | 461,953 | 236,795 | 276,631 |
| Equity per share (SEK) | 18.19 | 23.65 | 13.67 | 16.46 |
| Equity per share (%) | 85 | 97 | 94 | 98 |
| Average number of employees | 48 | 39 | 30 | 16 |
| Average number of employees in R&D |
19 | 17 | 16 | 11 |
Definitions
| Key indicator | Definition | Motivation for using financial key indicator not defined pursuant to IFRS |
|---|---|---|
| Net sales | Revenues from goods and services sold, and royalties received rela ting to the main activity during the relevant period. |
|
| Operating earnings/loss | Earnings/loss before financial items and tax. |
Operating earnings/loss provides a view of the earnings that the company's ordinary activities have generated. |
| Basic and diluted earnings per share |
Earnings/loss divided by the weighted number of shares in the period before and after dilution respectively. |
|
| Average number of shares before and after dilution |
The average number of outstan ding shares in the period before and after dilution respectively. Because the group is generating a loss, there is no dilution, despite the subscription price being lower than the share price. |
|
| R&D expenses | The company's direct expenses for research and development. Expenses for staff, materials and external services. |
The company's main activity is research and development. Management considers that R&D expenses are an important parameter to monitor as an indicator of activity levels within the company. |
| R&D expenses as a percentage of operating expenses |
R&D expenses divided by ope rating expenses, which include other external expenses, person nel expenses, depreciation and amortization. |
Management considers that the company's R&D expenses in relation to total expenses are an important indication of the proportion of total expenses that are used for the company's main activity. |
| Cash and cash equiva lents |
Cash and bank balances. | |
| Cash flow from opera ting activities |
Cash flow before cash flow from investing activities and financing activities. |
|
| Cash flow for the period (SEK 000) |
The change in cash and cash equi valents for the period excluding effective unrealized exchange rate gains and exchange rate losses. |
|
| Equity per share (SEK) | Equity divided by the number of shares.divided by the number of shares at the end of the period. |
Management follows this indicator to monitor the value of equity per share. |
| Equity/assets ratio | Equity as a percentage of total assets |
Management follows this indicator of the company's financial stability. |
| Average number of employees |
The average number of employ ees is the total of working-hours in the period divided by scheduled working hours for the period. |
|
| Average number of employees in R&D |
The average of the number of employees in the company's rese arch and development functions. |
Parent company's income statement, summary
Key indicator Definition
Operating earnings/loss Earnings/loss before financial
Revenues from goods and services sold, and royalties received relating to the main activity during
the relevant period.
Earnings/loss divided by the weighted number of shares in the period before and after dilution
The average number of outstanding shares in the period before and after dilution respectively. Because the group is generating a loss, there is no dilution, despite the subscription price being lower
The company's direct expenses for research and development. Expenses for staff, materials and
R&D expenses divided by operating expenses, which include other external expenses, personnel expenses, depreciation and
Cash flow before cash flow from investing activities and financing
The change in cash and cash equivalents for the period excluding effective unrealized exchange rate gains and exchange rate losses.
Equity divided by the number of shares.divided by the number of shares at the end of the period.
The average number of employees is the total of working-hours in the period divided by scheduled working hours for the period.
The average of the number of employees in the company's research and development functions.
items and tax.
respectively.
than the share price.
external services.
amortization.
activities.
Equity/assets ratio Equity as a percentage of total assets
lents Cash and bank balances.
Net sales
Basic and diluted earnings per share
Average number of shares before and after
dilution
R&D expenses
R&D expenses as a percentage of operating
Cash and cash equiva-
Cash flow from operating activities
Cash flow for the period
Equity per share (SEK)
Average number of employees
Average number of employees in R&D
expenses
(SEK 000)
Motivation for using financial key indicator not defined pursuant to IFRS
Operating earnings/loss provides a view of the earnings that the company's ordinary activities
The company's main activity is research and development. Management considers that R&D expenses are an important parameter to monitor as an indicator of activity levels
Management considers that the company's R&D expenses in relation to total expenses are an important indication of the proportion of total expenses that are used for the
Management follows this indicator to monitor
Management follows this indicator of the
the value of equity per share.
company's financial stability.
have generated.
within the company.
company's main activity.
| 2019 | 2018 | 2019 | 2018 | |
|---|---|---|---|---|
| SEK thousands | Oct-Dec | Oct-Dec | Full year | Full year |
| Operating income etc. | ||||
| Net sales | 45 | 91 | 356 | 333 |
| Capitalized work for own account | 8,125 | 5,224 | 26,716 | 25,052 |
| Other operating income | 64 | 257 | 557 | 744 |
| Total | 8,234 | 5,572 | 27,629 | 26,129 |
| Operating expenses | ||||
| Other external expenses | -22,396 | -15,996 | -79,046 | -59,679 |
| Personnel costs | -10,755 | -8,705 | -38,326 | -32,003 |
| Amortization of intangible and | ||||
| tangible fixed assets | -793 | -565 | -2,950 | -1,996 |
| Other operating expenses | 0 | -110 | -435 | -527 |
| Total operating expenses | -33,944 | -25,375 | -120,757 | -94,205 |
| Operating earnings/loss | -25,710 | -19,803 | -93,128 | -68,076 |
| Profit/loss from financial items | ||||
| Financial income | 401 | 308 | 4 ,981 | 1,743 |
| Financial expenses | -2,719 | 0 | -2 721 | -1 |
| Total financial items | -2,318 | 308 | 2,260 | 1,742 |
| Result after financial items | -28,028 | -19,495 | -90,868 | -66,334 |
| Allocations | ||||
| Group contribution | 337 | 0 | 337 | 0 |
| Earnings/loss after financial items | -27,691 | -19,495 | -90,531 | -66,334 |
| Income tax | 0 | 0 | 0 | 0 |
| Earnings/loss for the period | -27,691 | -19,495 | -90,531 | -66,334 |
Consolidated comprehensive income, summary
| 2019 | 2018 | 2019 | 2018 | |
|---|---|---|---|---|
| SEK thousands | Oct-Dec | Oct-Dec | Full year | Full year |
| Periodens resultat | -27,691 | -19,495 | -90,531 | -66,334 |
| Earnings/loss for the period | 0 | 0 | 0 | 0 |
| Comprehensive income for the period | -27,691 | -19,495 | -90,531 | -66,334 |
Parent company's financial position, summary
| 2019 | 2018 | |
|---|---|---|
| SEK thousands | Dec 31 | Dec 31 |
| ASSETS | ||
| Fixed assets | ||
| Intangible fixed assets | 90,907 | 60,868 |
| Tangible fixed assets | 12,257 | 8,989 |
| Financial fixed assets | 303 | 253 |
| Total fixed assets | 103,467 | 70,110 |
| Current assets | ||
| Accounts receivable | 0 | 32 |
| Receivables from Group companies | 53,579 | 29,984 |
| Current receivables | 3,254 | 8,465 |
| Prepaid expenses and accrued income | 3,416 | 3,843 |
| Cash and cash equivalents | 261,647 | 385,517 |
| Total current assets | 321,896 | 427,841 |
| TOTAL ASSETS | 425,363 | 497,951 |
| EQUITY AND LIABILITIES | ||
| Equity | ||
| Restricted equity | ||
| Share capital | 983 | 977 |
| Fund for development expenses | 65,569 | 39,144 |
| 66,552 | 40,120 | |
| Non-restricted equity | ||
| Premium fund | 10,232 | 312,178 |
| Retained earnings including comprehensive income |
325,673 | 130,452 |
| 335,905 | 442,630 | |
| Total equity | 402,457 | 482,750 |
| Current liabilities | ||
| Other liabilities | 22,906 | 15,201 |
| Total current liabilities | 22,906 | 15,201 |
| TOTAL EQUITY AND LIABILITIES | 425,363 | 497,951 |
Parent company's cash flow statement, summary
| 2019 | 2018 | |
|---|---|---|
| SEK thousands | Full year | Full year |
| Operating activities | ||
| Operating earnings/loss | -93,128 | -68,076 |
| Adjustment for items not included in cash flow | 2,950 | 2,230 |
| Interest received | 270 | 306 |
| Interest paid | -2 | -1 |
| Tax paid | 0 | 0 |
| Cash flow from operating activities before changes in working capital |
-89,910 | -65,541 |
| Cash flow from changes in working capital | ||
| Change in operating receivables | -15,933 | -23,826 |
| Change in operating liabilities | 8,042 | 1,332 |
| Cash flow from operating activities | -97,801 | -88,035 |
| Investment activities | ||
| Investment in Intangible fixed assets | -30,568 | -27,341 |
| Investment in tangible fixed assets | -5,980 | -6,149 |
| Investment in financial fixed assets | -50 | -253 |
| Cash flow from investment activities | -36,598 | -33,743 |
| Financing activities | ||
| National and European grants for development expenses |
291 | 2,791 |
| New share issue | 10,238 | 311,352 |
| Warrant subscription premiums received | 0 | 936 |
| Cash flow from financing activities | 10,529 | 315,079 |
| Cash flow for the period | -123,870 | 193,301 |
| Cash and cash equivalents at start of period | 385,517 | 192,216 |
| Cash and cash equivalents at period's end | 261,647 | 385,517 |
Accounting principles
Accounting principles
The Group applies the Swedish annual accounts act and International Financial Reporting Standards (IFRS) as adopted by the EU, and RFR 1 complementary accounting rules for Groups when preparing financial reports. The parent company applies the Swedish annual accounts act and RFR 2 Accounting for legal entities when preparing financial reports. From January 1, 2019, the Group is applying IFRS 16 Leases. Otherwise, the applied accounting principles are consistent with those applied in the 2018 annual report.
This interim report has been prepared in accordance with IAS 34 Interim Financial Reporting.
IFRS 16 Leasing
IFRS 16 Leases came into effect from January 1, 2019. Immunovia has applied the simplified transition method, which means that comparatives have not been restated. The lease liability consists of the discounted remaining leasing payments as at January 1, 2019. The right-of-use asset for all leases corresponds to the lease liability adjusted for prepaid or accrued lease payments reported in the statement of financial position as at January 1, 2019. The transition to IFRS 16 has not had any effect on equity. Immunovia applies practical expedients allowed under IFRS 16 for leases where the underlying asset has a low value and for short-term leases, which also includes leases that terminate in 2019.
The most significant leases are rental agreements for office premises. The Group's total assets have increased as a result of the inclusion of right-of-use assets and lease liabilities following the introduction of IFRS 16. Under IAS 17, lease payments in the comparative year were reported as other external expenses in the income statement. These have now been replaced by depreciation of the right-of-use asset, recognized as an expense in operating profit/loss, and interest on the lease liability, recognized as a financial expense. The lease payment is apportioned between repayment of the lease liability and payment of interest.
The outstanding lease payments were measured at their present value using Immunovia's incremental borrowing rate, which was 4%. The following adjustments to the Group's balance sheet have been made as at January 1, 2019.
(SEK thousands)
| Property, plant and equipment, right-of-use assets | 36,067 |
|---|---|
| Current receivables, prepaid expenses | -610 |
| Total | 35,457 |
| Interest-bearing liabilities –non-current, leasing liabilities | 31,450 |
| Interest-bearing liabilities – current, Leasing liability | 4,007 |
| Total | 35,457 |
With regard to the existing leasing portfolio in 2019, Immunovia estimates that depreciation will increase by SEK 4.6 million, financial expenses will increase by SEK 1.3 million and earnings after tax will fall by SEK 589,000.
The Group has increased existing premises and taken into account index increases, which has resulted in an increase in the right to use assets by 7,115 in 2019.
| Reconciliation of operating lease obligations under IAS 17 and lease liabilities under IFRS 16 | ||
|---|---|---|
| (SEK thousands) | ||
| Operating lease obligations Dec 31, 2018 | 20,586 | |
| Additional extension period | 21,806 | |
| Total | 42,392 | |
| Effect of current value measurement | -6,325 | |
| Prepayments | -610 | |
| Lease liability recognized | 35,457 | |
The Parent Company applies the exception allowed in RFR 2, which means that IFRS 16 is not required to be applied in a legal entity.
New and amended standards adopted with effect from 2019 are not otherwise expected to have any significant impact on the Group's financial position.
OTHER INFORMATION
Financial instruments
The Group currently has no financial instruments valued at fair value. Instead, all financial assets and liabilities are valued at accrued acquisition cost. It is estimated that there are no significant differences between fair value and book value relating to financial assets and liabilities. The reported value of financial assets on the balance sheet date amounted to SEK 266.6 million (396.0).
Transactions with related parties
In addition to salaries and other remuneration to company management, and fees to Board members, as decided at the annual general meeting, the company has a consulting agreement with CB Ocean Capital AB regarding services performed by Immunovia's chairman and largest shareholder, Carl Borrebaeck. Services provided do not concern information relating to the Board role. Instead the services are to provide the company with scientific and strategic support at scientific presentations and conferences, for example. This agreement runs until further notice with three months' notice for both parties and remuneration per quarter amounts to SEK 41,000.
Risks
Immunovia is exposed to financial risks and business risks. Financial risk management and the financial risks are described below. The company's business risks are presented on page 41 of the 2018 annual report. No significant changes have occurred that affect these reported risks.
Market risks
Currency risks
The Group operates both nationally and internationally, which involves exposure to fluctuations in various currencies, in particular USD and EUR. Currency risk arises from future commercial transactions and recognized assets and liabilities. The extent of the company's business currently means that the net exposure in foreign currencies is limited. The company therefore does not have a currency hedging policy.
Interest rate risk in cash flow
Interest rate risk is the risk that the value of financial instruments will fluctuate because of changes in market interest rates. The Group currently only has interest-bearing financial assets in the form of bank deposits.
Credit risk
Credit risk is the risk of one party in a transaction with a financial instrument failing to meet its obligation. The maximum exposure to credit risk on financial assets as of December 31, 2019 was SEK 266.6 million (396.0).
Liquidity risk
Prudent liquidity risk management implies maintaining sufficient cash or agreed credit options to close market positions. Based on the existing business plan, there is enough liquidity for approximately 1.5 years.
OTHER INFORMATION
Financial calendar
Interim report Jan-March 2020 Tuesday April 28, 2020 Annual General Meeting 2020, Thursday May 7, 2020 Interim report Jan-June 2020, Thursday August 20, 2020 Interim report Jan-Sep 2020, Thursday November 12, 2020 Financial statement 2020, Wednesday February 17, 2021
Contact information:
Immunovia AB (publ), Medicon Village, Scheelevägen 2, 223 81 Lund, Sweden Tel: +46 (0)46-2756 000 Email: [email protected] Web: www.immunovioa.com For further information please contact • Mats Grahn, vd • e-post: [email protected] • Julie Silber, IR Director • e-post: [email protected] Tel : +46(0)79 3486277
Telephone conference: February 14, 2020, at 8.30 am (CET)
This interim report has not been reviewed by the company's auditors. The Board and the CEO certify that the interim report gives a true and fair view of the company's and the Group's operations, position and results, and describes significant risks and uncertainties that the Group faces.
Lund, February 14, 2020
Carl Borrebaeck Chairman
Hans Johansson Board member
Ann-Christine Sundell Board member
Christofer Sjögren Board member
Mimmi Ekberg Board member Mats Grahn CEO
Glossary
Antigen. Actionable information – Information that is sufficiently authoritative and specific to be used in clinical decision making.
Antibodies – Antibodies, or immunoglobulins, are a type of protein used by the body's immune system to detect and identify foreign substances such as viruses, bacteria or parasites.
Antigen – A foreign body substance that elicits a reaction of the immune system in contact with the organism. The substance may be a chemical substance, a protein or a carbohydrate.
Autoimmunity – Autoimmunity is the immune system's harmful attack on the body's own tissue, which can take the form of disease or rejection of organs during transplantation.
Benign – If a tumor is benign it means that the tumor is not dangerous and will not spread.
Bioinformatics – Bioinformatics is an interdisciplinary field in which algorithms are developed for the analysis of biological (especially molecular biology) data.
Biomarker – A biomarker can be defined as a biological response to a change caused by disease or foreign substance. Biomarkers can be used as early warning signs of biological changes in an organism.
Companion Diagnostics – Diagnostics tools aimed at identifying which groups of patients will respond well to a particular treatment and thus ruling out ineffective treatments.
Discovery Trial – Research carried out in order to verify a special hypothesis.
Histology – Histology is the study of biological tissue.
Invasive – Invasive means to penetrate or attack. Invasive medical examinations refer to examinations that include any form of penetration through a hole in the body or surgical operation.
Malignant – Malignant tumors tend to worsen and become mortal. They are termed cancer, and thus differ from benign tumors.
Metastasis – A metastasis is a tumor that has spread to other organs.
Microarray – A microarray is a molecular biology test format for simultaneously measuring the relative concentrations of proteins.
Molecular Diagnosis – A collection of technologies used to analyze biological markers at the genomic and protein levels (i.e., the genetic code of individuals and how their cells express their genes as proteins in the body), using molecular biology for medical testing. These technologies are used to diagnose and monitor disease, detect the risk of disease and to determine which treatment is likely to work best for the individual.
NSCLC – Non-Small Cell Lung Cancer, the most common type of lung cancer, 80-85% of all lung cancer cases.
Palliative care – Palliative care is administered when the patient's disease is beyond the ability to cure. The purpose of palliative care is to provide support to patients and families using both psychological and medical practices.
PanDIA-1 – Prospective trial for the diabetes risk group of patients aged over 50 recently diagnosed with type-2 diabetes.
PanFAM-1 – Prospective trial for familiar and hereditary risk groups.
Pancreatologist – Doctor specializing in diseases relating to the pancreas.
PanSYM-1 – Prospective trial for early symptom risk groups.
Prospective trial – A trial in which a group of individuals is studied and followed often for a long time to see how a particular disease develops. A prospective trial is used to study the relationship between different risk factors and a certain disease. You follow individuals with and without risk factors going forwards over time. At the end of the trial, the proportion of individuals in the two groups who developed disease is compared.
Proteomics – Proteomics is a branch of biology and includes surveys of large amounts of data about proteins.
RA – Rheumatoid arthritis, one of the most common autoimmune diseases.
RA double negative – Patients who have RA, but test negative for it using the current two single-marker standard tests, RF factor and anti-CCP.
Reproducibility – Within the field of statistics, reproducibility is described as the correlation between results from repeated measurements performed by different observers with different instruments of the same type, which measurements are performed in order to reject any measurement error due to materials and personnel.
Retrospective study – A study in which the focus is on some- thing that has happened in the past, i.e. using historic data. This form of study starts with the answer, i.e. it is known which individuals became ill and which did not.
Screening – Screening refers to medical examinations to identify a disease. It is normally carried out before the patient has exhibited obvious symptoms.
Self-pay customers – Patients or organizations that pay without reimbursement from insurance companies or authorities.
Sensitivity – Sensitivity is a statistical measure of the reliability of a binary diagnostic test and the probability that a generated positive result is correct.
Serum – A serum is a transparent yellowish liquid obtained by allowing the blood to clot, and then removing the blood cells and the coagulation proteins. Serum contains proteins, including antibodies.
SLE (Systemic Lupus Erythematosus) – SLE is an autoimmune inflammatory disease which means that the immune system attacks the body. The symptoms come and go in cycles, sometimes the patient is sick and sometimes has no sickness at all. Usually it is the joints, skin, blood and kidneys which become inflamed, but also the nervous system, lungs and heart can be affected. The disease is currently difficult to diagnose and is often confused with other autoimmune diseases.
Specificity – Specificity is a statistical measure of the reliability of a binary diagnostic test and the probability that the generated negative result is de facto negative.
Vinnova – Vinnova is a Swedish government agency under the Ministry of Industry which aims to promote sustainable growth by improving conditions for innovation and by funding needs-driven research.
Immunovia in brief
Immunovia is a Swedish molecular diagnostic company with a strong financial position in a commercial phase. The company develops and commercializes diagnostic tools for complex forms of cancer and autoimmune diseases.
Immunovia AB was founded in 2007 by researchers from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden. The purpose was to establish a base from which to make scientific discoveries and gain patents within the fields of human antibodies, biomarkers and antibody arrays, covering the stages from research to clinical application. Immunovia's core technology platform, IMMray™, is based on microarray analysis of biomarker antibodies. IMMray™ PanCan-d is the company's primary diagnostic tool, capable of diagnosing with a high level of sensitivity and specificity. This enables diagnosis of patients with pancreatic cancer before symptoms are noted (stages I and II), which is not currently possible with existing methods. Immunovia is now performing clinical validation studies to prepare for the commercialization of IMMray™ PanCan-d, which could become the first blood-based test for early diagnosis of pancreatic cancer. The antibody-based technology platform, IMMray™, is the result of 15 years of research at CREATE Health, Lund University. It is used to decode mechanisms behind the body's immune system, the first system in the body that reacts to disease. The platform can also be used for the development of diagnostic tests for autoimmune diseases.
Pancreatic cancer
Each year about 338,000 patients fall ill with pancreatic cancer. This form of cancer has one of the worst survival forecasts and only about 5% of diagnosed patients live more than five years, making it one of the deadliest cancers in the world. It is estimated that early detection would increase the five-year survival rate by around 50%. The initial addressable market for Immunovia consists of two high-risk pancreatic cancer groups. The market in the US and Europe for diagnosis of these groups is estimated to be worth over SEK 30 billion anually.
Goal
Immunovia's goal is to provide diagnostic tests that will enable earlier, more efficient and more accurate diagnosis of patients who run the risk of developing cancer or autoimmune disease. The aim is to make Immunovia's tests the first choice of specialist doctors and general practitioners across the world in the screening of especially high-risk groups or when there is a suspicion of the aforementioned diseases.
Strategy
Immunovia's strategy is as the first company, to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases earlier and more accurately than previously possible. The focus is on unsolved problems in early diagnosis, monitoring of the course of a disease and the patient's response to treatment. These are areas where there are extensive clinical benefits for patients and the healthcare system, current solutions are lacking or insufficient, and where IMMray™ has significant competitive advantages.
Initially, the key focus for Immunovia is to bring IMMray™ PanCan-d to the market. Because early detection of pancreatic cancer constitutes a major clinical problem, Immunovia considers there to be good prospects for being the first to establish a strong position on the market.
Organization. no. 556730-4299
Immunovia has its head office in Lund. Sweden Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm's main list (Mid Cap). For more information, please go to: www.immunovia.com
Scheelevägen 2, Medicon Village 223 81 Lund, Sweden Phone: 046-2756 000 [email protected] www.immunovia.com
Early detection would increase the five-year survival rate by around 50%
IMMray™ PanCan-d, could become the first blood-based test for early diagnosis of pancreatic cancer.
EARLY DETECTION