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Immunovia
Quarterly Report • Aug 30, 2023
3061_ir_2023-08-30_91f113e4-8672-4737-8062-ee1dadfc59db.pdf
Quarterly Report
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2023 INTERIM REPORT JANUARY – JUNE
April-June 2023
- Net sales amounted to kSEK 412 (103) divided by sales of tests kSEK 351 (45) and royalties kSEK 61 (58).
- Net earnings were MSEK -170 (-34) and earnings per share before and after dilution were SEK -4.00 (-1.49).
- Earnings during the second quarter has been charged with SEK 141 million, which mainly consist of non-cash flow oneoff costs such as depreciation and write-downs of intangible assets as a result of the decision to cease commercialization of the IMMray™ PanCan-d test in the US, but also termination and severance pay which will have a cash impact.
- Cash Flow from operating activities amounted to MSEK -43 (-41).
- Cash and equivalents at the end of the period amounted to MSEK 144 (197).
- On April 12, the Company announced the outcome of the rights issue. The Rights Issue was subscribed to 75.1 percent and Immunovia thereby received approximately MSEK 151.8 before issue costs.
- On April 25, the Company gave notice for the Annual General Meeting on Friday 26th May 2023.
- On April 26, the Company announced a discussion on adoption of IMMray™ PanCan-d with key opinion leaders held on May 3.
- On April 29, the Company announced the appointment of Jeff Borcherding as global CEO replacing Philipp Matthieu.
- On May 6, the Company announced that the board member Philipp von Hugo resigned from Immunovia's board at his own request.
- On May 22, the Company informed on changes to the Nomination Committee's proposal to the Annual General Meeting 2023 and in addition to the previously proposed re-election of Peter Høngaard Andersen, the Nominating Committee proposed re-election of Hans Johansson and Martin Møller and new election of Michael Löfman.
- On May 26, the Company published the summary of the resolutions made at the Annual General Meeting 2023.
- On May 31, the Company informed that, as a result of new shares being issued in the rights issue the number of outstanding shares and votes have increased by 22,655,917, from 22,631,581 to 45,287,498.
- On June 9, the Company informed that Jeff Borcherding, CEO of Immunovia, purchased 350 000 shares for approximately kSEK 670.
Significant events after the period
• On July 11, the Company announced that it will cease commercialization of IMMray™ PanCan-d test in the United States to focus resources on development of the next generation pancreatic cancer detection test.
"As announced in July, we are significantly restructuring Immunovia to focus on our novel next-generation test for detection of pancreatic cancer. These changes are difficult but necessary to improve the company's runway and strengthen our product offering. We continue to move quickly to streamline our operations, develop our next-generation test, and optimize our cost structure. Development of the next-generation is progressing well, and we expect to conduct clinical studies during 2024."
Jeff Borcherding, CEO and President, Immunovia AB
Key indicators
| SEK thousand unless otherwise stated | 2023 April-June |
2022 April-June |
2023 Jan-June |
2022 Jan-June |
2022 Full year |
|---|---|---|---|---|---|
| Net sales | 412 | 103 | 931 | 285 | 1,145 |
| Operating earnings/loss | -185,075 | -50,787 | -234,164 | -98,154 | -191,150 |
| Earnings before tax | -170,205 | -33,726 | -221,863 | -77,838 | -168,092 |
| Net earnings | -170,205 | -33,726 | -221,863 | -77,838 | -168,092 |
| Earnings per share before dilution (SEK) | -4.00 | -1.49 | -6.81 | -3.44 | -7.43 |
| Earnings per share after dilution (SEK) | -4.00 | -1.49 | -6.81 | -3.44 | -7.43 |
| Equity ratio (%) | 69 | 84 | 69 | 84 | 81 |
| Number of shares at the end of the period | 45,287,498 | 22,631,581 | 45,287,498 | 22,631,581 | 22,631,581 |
CEO's comments
As announced in July, we are significantly restructuring Immunovia to focus on our novel next-generation test for detection of pancreatic cancer. These changes are difficult but necessary to improve the company's runway and strengthen our product offering. We continue to move quickly to streamline our operations, develop our next-generation test, and optimize our cost structure. Development of the next-generation is progressing well, and we expect to conduct clinical studies during 2024.
We are rapidly creating a new Immunovia grounded in our existing strengths. We are true to our vision, we have unique assets, we are cost efficient, and we are focused on our clinical mission: to save lives through early detection of pancreatic cancer
External and internal challenges required significant action
Our strategic reset was triggered primarily by three key external challenges. First, private insurers and government payers in the U.S. require extensive clinical evidence supporting the accuracy and clinical utility of diagnostic tests before they are willing to pay for those tests. Second, proving clinical utility in pancreatic cancer detection is difficult, often requiring large studies conducted over many years. To demonstrate clinical utility in a prospective study at a reasonable cost, we must participate in large studies conducted by a consortium of sites. These trials will likely study more than one test, including other commercial assays and CA19-9 alone. We must be confident that our test will succeed in this comparison. Third, overall access to capital has declined significantly, especially for pre-profit companies like Immunovia.
These external dynamics amplified internal product and financial challenges at Immunovia. Our product, the IMMray™ PanCan-d test, was limited by its reliance on CA19-9, one of the biomarkers in the test. CA19-9 is also not produced by about 10% of the general population, preventing the use of the test in these patients. Worse, the inability to produce CA19-9 disproportionately impacts certain people, including those of African ancestry and Hispanic ethnicity. These populations also show a higher prevalence of pancreatic cancer. As a result, we have both a moral and clinical obligation to serve these individuals equally and eliminate healthcare disparities. We could not do so with our first-generation IMMray™ PanCan-d test.
Financially, our prior efforts to reduce operating costs were not sufficient. Commercializing the IMMray™ PanCan-d test required a significant investment in selling and marketing in the U.S. Producing testing supplies for the proprietary IMMray platform also resulted in substantial labor and materials costs in Lund.
These dynamics led the Board and management to conclude that the best and most viable path forward was to discontinue selling the current IMMray test, significantly reduce expenses, and focus resources on developing and testing our next-generation product.
Our next-generation test provides reason for optimism
Despite these tough decisions, I am excited about the promise of our next-generation test for the early detection of pancreatic cancer. The test will incorporate new biomarkers identified through a discovery study evaluating thousands of proteins circulating in the blood. The new test is being designed to work across racial and ethnic groups without compromising accuracy. It will be conducted on a commercially available lab testing platform, achieving scale, reducing fixed costs, and lowering future cost of goods sold.
We have strong assets moving forward: Development expertise, an extensive sample bank and strong relationships
The experience, assets, and relationships Immunovia has built over the years will enable us to accelerate development of the next generation test. For example, our research and development partnership with Proteomedix is highly productive and gives us access to leading experts in proteomics test development. We have accumulated thousands of blood samples which we will use to develop and test our new product. Relationships with investigators, key opinion leaders and advocacy associations in the U.S. and Europe will enable us to test the assay in clinical studies that these investigators are leading. In summary, Immunovia maintains unique strengths to solve the clinical challenge of early detection of pancreas cancer.
We are dramatically improving our cost structure
In parallel with increasing our focus on the next-generation product, we are optimizing our cost structure in a significant way by reducing staffing and operating expenses. We forecast that our burn rate will be in the range of 25-30 MSEK per quarter beginning in Q1 2024, down 15-20 MSEK vs. Q1/ Q2 2023. After accounting for transition costs of approx. 20 MSEK, we expect to have sufficient cash to support operations through the end of 2024 or early 2025.
Earnings during the second quarter has been charged with SEK 141 million, which mainly consist of non-cash flow one-off costs such as depreciation and write-downs of intangible assets, but also termination and severance pay which will have a cash impact.
Going forward, we will benefit from lower fixed costs and reduce our cost of goods sold by transitioning from the proprietary IMMray platform, which required in-house production of arrays and other supplies, to a commercially available platform.
We have a clear vision for achieving our mission
Our mission has not changed: We will save lives through early detection of pancreatic cancer. What has changed is how we achieve our mission. Going forward, Immunovia will be leaner and more capital efficient.
Critically, we will partner at nearly every stage of the product life cycle to leverage the expertise of our collaborators and reduce costs. For product development, we will continue to partner with Proteomedix. For clinical research, we will partner with investigators and research consortia who are conducting early detection trials. For production, we will transition from the high-cost, proprietary IMMray testing platform to a widely used approach called ELISA. Finally, we will explore a variety of options to commercialize the new test in order to drive awareness and adoption in a less capital-intensive way.
We are creating a very different Immunovia—one that is leaner, more agile, more cost-conscious, and more connected to our customers and patients. I realize the journey to this point has been very difficult for our investors, stakeholders, and employees. Please know that we are working hard to create the company that will reward you for your investment in Immunovia.
August 30, 2023 Jeff Borcherding President & CEO, Immunovia AB
4
Table of contents
| Group's performance over the period 5 | |
|---|---|
| Share information 6 | |
| Incentive scheme 8 | |
| Consolidated income statement in summary 9 | |
| Consolidated comprehensive income in summary 9 | |
| Consolidated financial position in summary 10 | |
| Change in consolidated equity in summary 11 | |
| Consolidated cash flow statement in summary 12 | |
| Consolidated key indicators 13 | |
| Definitions 14 | |
| Parent company's income statement in summary 15 | |
| Parent company's comprehensive income in summary 15 | |
| Parent company's financial position in summary 16 | |
| Parent company's cash flow statement in summary 17 | |
| Notes 18 | |
| Glossary 25 | |
| Immunovia in brief27 |
About the report
This information was submitted for publication on August 30, 2023, at 08:30 (CET).
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, Immunovia GmbH, Immunovia Dx Laboratories AB and Immunovia Incentive AB.
Contact
Immunovia AB (publ), Swedish Corporate Identity Number 556730-4299, Medicon Village, Scheelevägen 8, 223 63 Lund, Sweden
• [email protected] • +46 46 2756 000
For further information please contact
Jeff Borcherding, CEO and President
Karin Almqvist Liwendahl, CFO
january-june 2023
The Group's performance over the period
Net sales
Net sales for the second quarter amounted to kSEK 412 (103), of which kSEK 351 (45) consisted of sales of tests and kSEK 61 (58) were royalties. For the first half of 2023, net sales amounted to kSEK 931 (285), of which kSEK 730 (167) consisted of sales of tests and kSEK 201 (118) were royalties.
Earnings
Net earnings for the second quarter amounted to MSEK -185.1 (-33.7). Earnings during the second quarter have been charged with SEK 141 million, which mainly consist of non-cash flow one-off costs such as depreciation and write-downs of intangible assets as a result of the decision to cease commercialization of the IMMray™ PanCan-d test in the US, but also termination and severance pay which will have a cash impact. With the decision to cease the commercialization of the IMMRay™ PanCan-d test, uncertainties in the impairment test as of June 30, 2023, were confirmed. This has resulted in a full write-off of capitalized development costs as well as related patent and license costs.
During Q2 other external costs and personnel costs increased by MSEK 5.4 compared with the corresponding period last year and amounted to a total of MSEK 49.2. The increase is primarily due to increased personnel costs through provisions for termination costs and severance pay.
Research & Development
Costs for research and development for the second quarter amounted to MSEK 8.2 (12.0), which corresponded to 12 percent (24) of the Group's total operating expenses.
Financing and cash flow
Cash flow from operating activities during the second quarter amounted to MSEK -43.3 (-40.9), and does not include any items of a one-off nature.
Cash and cash equivalents as of June 30, 2023, amounted to MSEK 144 (197).
Equity at the end of the period amounted to MSEK 131 (339) and the equity/assets ratio was 69 percent (86). A directed new share issue has been carried out during the second quarter of 2023, which brought the company MSEK 151.8 before deduction of issue costs.
With a cash position of MSEK 144, along with the expected effects of the ongoing reconstruction, the Board's assessment is that the company's continued operation based on current plans is financed through the end of 2024 or early 2025.
Investments
In the second quarter of 2023, intangible assets totaling kSEK 1,061 (91) were acquired, consisting of balanced expenses for development work SEK 0 thousand (0) as well as patents kSEK 35 (91) and licenses 1,026 (0). In the first half of 2023, intangible assets totaling kSEK 1,061 (230) were acquired, consisting of balanced expenses for development work kSEK 0 (0) and patents kSEK 35 (230) and licenses 1,026 (0).
Investments in tangible fixed assets in the form of inventories were made during the second quarter of 2023 with kSEK 0 (832). During the first half of 2023, investments were made in tangible fixed assets of kSEK 0 (1,256).
No financial investments were made during the second quarter 2023.
Employees
The average number of employees during the second quarter was 45 (65) and at the end of the period the number of employees was 39 (64). There will be a substantial reduction in the number of employees as a result of the ongoing restructuring.
Share information
The number of registered shares amounted to 45,287,498 shares at the end of the reporting period. The share's nominal value is SEK 0.05.
| Share capital 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 | |
| June 4, 2020 | New share issue | 1,130,154.05 | 147,411.40 | 22,603,081 | 2,948,228 | 0.05 | |
| Oct 4, 2020 | New share issue via warrants |
1,131,579.05 | 1,425.00 | 22,631,581 | 28,500 | 0.05 | |
| April 12, 2023 | New share issue | 2,264,374.90 | 1,132,795.85 | 45,287,498 | 22,655,917 | 0.05 | |
| At end of period | 2,264,374.90 | 45,287,498 | 0.05 |
The 10 largest shareholders on June 30, 2023
| Shareholders | No. of shares | Share (capital and votes) |
|---|---|---|
| Avanza Pension | 3,994,550 | 8.82% |
| Nordnet Pensionsförsäkring AB | 1,748,833 | 3.86% |
| Carl Borrebaeck | 1,709,900 | 3.78% |
| Coeli Wealth Management AB | 1,431,752 | 3.16% |
| RBCB Lux Ucits Ex-Mig | 1,403,321 | 3.10% |
| Caceis Bank, Switzerland Branch, WBIMY | 1,359,706 | 3.00% |
| Shaps Capital AB | 1,072,909 | 2.37% |
| ISEC Services AB | 958,465 | 2.12% |
| Mats Ohlin | 848,950 | 1.87% |
| Sara Andersson Ek | 848,907 | 1.87% |
| Ten largest owners | 15,377,293 | 33.95% |
| Others | 29,910,205 | 66.05% |
| Total | 45,287,498 | 100.00% |
Source: Monitor by Modular Finance AB. Compiled and processed data from Euroclear, Morningstar and the Swedish Financial Supervisory Authority, among others
Long Term Incentive Programs
Immunovia has two outstanding warrant programs comprising 656,000 options with the right to subscribe for 656,000 shares. There is no dilution effect on earnings per share as long as the Group's earnings are negative.
Warrant program
The warrant programs are aimed at employees and key personnel in the company. At the time of allotment, all warrants have been valued according to Black & Scholes' valuation model. A summary of the company's warrant schemes can be found below.
Alternative cash-based incentive programs
In countries where the allotment of warrant programs is not appropriate for various reasons, it has been decided to introduce alternative cash-based incentive programs for employees and key personnel in the company. The alternative incentive programs are designed in such a way that their financial effect corresponds to the terms of the corresponding warrant program. The total cost to the company for the cash-based incentive programs is shown in the breakdown below.
All warrant programs are subject to customary recalculation terms in connection with share issues, etc.
Breakdown of outstanding incentive programs
| Incentive program | Decision date | Utilization period | Number of outstanding warrants |
Sub scription price/ share |
Change in share capital at full utilization |
Total cost of alternative cash-based incentive pro grams (USD) |
|---|---|---|---|---|---|---|
| Warrant program 2020/2024 |
Sep 23, 2020 | Jun 1, 2024 -- Jun 30, 2024 | 280,000 | 455.59 | 14,000.00 | |
| Warrant program 2020/2024 |
April 7, 2022 | Jun 1, 2026 -- Jun 30, 2026 | 376,000 | 88.69 | 18,800.00 | |
| Alternative cash based incentive pro gram 2020/2024 |
Sep 23, 2020 | Jun 1, 2024 -- Jun 30, 2024 | 49,765 | |||
| Total | 656,000 | 32,800.00 | 49,765 |
Consolidated income statement, summary
| 2023 | 2022 | 2023 | 2022 | 2022 | |
|---|---|---|---|---|---|
| SEK thousands | April-June | April-June | Jan-June | Jan-June | Full year |
| Operating income etc | |||||
| Net sales | 412 | 103 | 931 | 285 | 1,145 |
| Other operating income | 4 | 5 | 82 | 24 | 59 |
| Total operating income | 416 | 108 | 1,013 | 309 | 1,204 |
| Operating expenses | |||||
| Raw materials and consumables | -5,500 | -579 | -6,538 | -1,831 | -4,211 |
| Other external expenses | -17,363 | -20,238 | -37,917 | -40,370 | -77,749 |
| Personnel costs | -31,827 | -23,585 | -53,583 | -43,468 | -85,222 |
| Amortization and impairment of tangible and | |||||
| intangible assets | -130,711 | -6,337 | -136,784 | -12,548 | -24,913 |
| Other operating expenses | -97 | -156 | -355 | -246 | -259 |
| Total operating expenses | -185,498 | -50,895 | -235,177 | -98,463 | -192,354 |
| Operating earnings/loss | -185,075 | -50,787 | -234,164 | -98,154 | -191,150 |
| Profit/loss from financial items | |||||
| Financial income | 15,524 | 17,474 | 15,959 | 21,143 | 41,259 |
| Financial expenses | -647 | -413 | -3,658 | -827 | -18,201 |
| Total financial items | 14,877 | 17,061 | 12,301 | 20,316 | 23,058 |
| Earnings/loss after financial items | -170,205 | -33,726 | -221,863 | -77,838 | -168,092 |
| Income tax | 0 | 0 | 0 | ||
| Earnings/loss for the period | -170,205 | -33,726 | -221,863 | - 77,838 | -168,092 |
| Earnings per share before dilution (SEK) | -4.00 | -1.49 | -6.81 | -3.44 | -7.43 |
| Earnings per share after dilution (SEK) | -4.00 | -1.49 | -6.81 | -3.44 | -7.43 |
| Average number of shares | 42,518,441 | 22,631,581 | 32,575,011 | 22,631,581 | 22,631,581 |
| Number of shares at year's end | 45,287,498 | 22,631,581 | 45,287,498 | 22,631,581 | 22,631,581 |
Consolidated comprehensive income, summary
| 2023 | 2022 | 2023 | 2022 | 2022 | |
|---|---|---|---|---|---|
| SEK thousands | April-June | April-June | Jan-June | Jan-June | Full year |
| Earnings/loss for the period | -170,205 | -33,726 | -221,863 | -77,838 | -168,092 |
| Items that may be reclassified later in the income statement |
|||||
| Exchange rate differences for foreign net investment |
-2,128 | -14,670 | -11,912 | -17,405 | -22,647 |
| Other earnings/loss for the period | -2,128 | -14,670 | -11,912 | -17,405 | -22,647 |
| Comprehensive income for the period | -172,333 | -48,396 | -233,775 | -95,243 | -190,739 |
Consolidated financial position, summary
| 2023 | 2022 | 2022 | ||
|---|---|---|---|---|
| SEK thousands | Note | June 30 | June 30 | Dec 31 |
| ASSETS | ||||
| Fixed assets | ||||
| Intangible fixed assets | 3,4,5 | 2,914 | 140,462 | 133,597 |
| Tangible fixed assets | 6 | 36,602 | 52,846 | 47,877 |
| Financial fixed assets | 4 | 3,427 | 3,500 | |
| Total fixed assets | 39,520 | 196,735 | 184,974 | |
| Current assets | ||||
| Inventory | 0 | 1,596 | 2,016 | |
| Accounts receivable | 123 | 20 | 253 | |
| Other short term receivables | 6,582 | 8,096 | 7,305 | |
| Cash and cash equivalents | 143,878 | 197,447 | 106,041 | |
| Total current assets | 150,583 | 207,159 | 115,615 | |
| TOTAL ASSETS | 190,103 | 403,894 | 300,589 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Share capital | 2,264 | 1,132 | 1,132 | |
| Other contributed capital | 1,136,480 | 1,016,060 | 1,016,369 | |
| Translation reserve | -36,218 | -19,063 | -24,306 | |
| Retained earnings incl. total comprehensive income | -971,255 | -659,138 | -749,392 | |
| Total equity | 131,271 | 338,991 | 243,803 | |
| Long-term liabilities Interest-bearing liabilities |
6 | 22,903 | 35,616 | 32,700 |
| Total long-term liabilities | 22,903 | 35,616 | 32,700 | |
| Current liabilities | ||||
| Interest-bearing liabilities | 6 | 5,051 | 4,770 | 4,874 |
| Other liabilities | 7 | 30,878 | 24,517 | 19,212 |
| Total current liabilities | 35,929 | 29,287 | 24,086 | |
| TOTAL EQUITY AND LIABILITIES | 190,103 | 403,894 | 300,589 |
Change in consolidated equity, summary
| SEK thousands | Share capital |
Other contributed equity |
Reserves | Accumulated earnings/loss for the period |
Total equity |
|---|---|---|---|---|---|
| Opening balance January 1, 2022 | 1,132 | 1,015,730 | -1,658 | -581,300 | 433,904 |
| Comprehensive income for the period | -17,405 | -77,838 | -95,243 | ||
| Transactions with owners in their capacity as owners |
|||||
| Received as warrants premium | 330 | 330 | |||
| Closing balance June 30, 2022 | 1,132 | 1,016,060 | -19,063 | -659,138 | 338,991 |
| Comprehensive income for the period | -5,243 | -90,254 | -95,497 | ||
| Transactions with owners in their capacity ac owners |
|||||
| Recived as warrants premium | 309 | 309 | |||
| Closing balance December 31, 2022 | 1,132 | 1,016,369 | -24,306 | -749,392 | 243,803 |
| Comprehensive income for the period | -11,912 | -221,863 | -233,775 | ||
| Transactions with owners in their capacity as owners |
|||||
| New share issue | 1,132 | 150,662 | 151,794 | ||
| Share issue cost | -30,551 | -30,551 | |||
| Closing balance June 30, 2023 | 2,264 | 1,136,480 | -36,218 | -971,255 | 131,271 |
Consolidated cash flow statement, summary
| 2023 | 2022 | 2023 | 2022 | 2022 | |
|---|---|---|---|---|---|
| SEK thousands | April-June | April-June | Jan-June | Jan-June | Full year |
| Operating activities | |||||
| Operating earnings/loss | -185,082 | -50,787 | -234,164 | -98,154 | -191,150 |
| Adjustment for items not included in cash flow | 130,970 | 7,285 | 136,605 | 13,688 | 23,471 |
| Interest received | 803 | 134 | 1,237 | 271 | 745 |
| Interest paid | -646 | -413 | -1,011 | -827 | -1,494 |
| Tax paid | 0 | 0 | 0 | 0 | 0 |
| Cash flow from operating activities before changes in working capital |
-53 955 | -43,781 | -97,333 | -85 022 | -168,428 |
| Cash flow from changes in working capital | |||||
| Change in inventory | 2,359 | 132 | 2,021 | 803 | 438 |
| Change in operating receivables | 512 | 197 | 911 | -287 | 298 |
| Change in operating liabilities | 7 786 | 2,566 | 11 401 | -2 457 | -7,890 |
| Cash flow from operating activities | -43,298 | 40,886 | -83,000 | -86 963 | -175,582 |
| Investment activities | |||||
| Investment in intangible assets | -1,061 | -91 | -1,061 | -230 | -368 |
| Investment in tangible assets | 0 | -832 | 0 | -1 256 | -1,256 |
| Investment in financial fixed assets | 0 | 0 | 0 | 0 | 0 |
| Sale of fixed assets | 15 | 0 | 3,508 | 0 | 0 |
| Cash flow from investment activities | -1,046 | -923 | 2,447 | -1 485 | -1,624 |
| Financing activities | |||||
| Amortization of leasing liability | -1,627 | -1,393 | -3,195 | -2 729 | -5,746 |
| New share issue | 121,243 | 0 | 121,243 | 0 | 0 |
| Received warrants premiums | 0 | 350 | 0 | 330 | 639 |
| Cash flow from financing activities | 119,616 | -1,063 | 118,048 | -2 399 | -5,107 |
| Cash flow for the period | 75,272 | -42,872 | 37,495 | -90 847 | -182,313 |
| Cash and cash equivalents at start of period | 68,237 | 239,796 | 106,041 | 287 406 | 287,406 |
| Exchange rate difference in cash and cash | |||||
| equivalents | 369 | -523 | 342 | 888 | 948 |
| Cash and cash equivalents at end of period | 143,878 | 197,447 | 143,878 | 197 447 | 106,041 |
Consolidated key indicators
| 2023 | 2022 | 2023 | 2022 | 2022 | |
|---|---|---|---|---|---|
| April-June | April-June | Jan-June | Jan-June | Full year | |
| Operating earnings/loss (SEK 000) | -185,075 | -50,787 | -234,164 | -98,154 | -191,150 |
| Earnings/loss for the year (SEK 000) | -170,205 | -33,726 | -221,863 | -7,838 | -168,092 |
| Earnings per share before dilution (SEK) | -4.00 | -1.49 | -6.81 | -3.44 | -7.43 |
| Earnings per share after dilution (SEK) | -4.00 | -1.49 | -6.81 | -3.44 | -7.43 |
| R&D expenses (SEK 000) | -8,244 | -11,957 | -17,432 | -25,213 | -47,902 |
| R&D expenses as percentage of operating expenses (%) |
12 | 24 | 15 | 24 | 25 |
| Cash and cash equivalents at the period's end (SEK 000) |
143,878 | 197,447 | 143,878 | 197,447 | 106,041 |
| Cash flow from operating activities (SEK 000) | -43,298 | -40,886 | -83,000 | -86,963 | -175,582 |
| Cash flow for the period (SEK 000) | 75,272 | -42,872 | 37,495 | -90,847 | -182,313 |
| Equity (SEK 000) | 131,271 | 338,991 | 131,271 | 338,991 | 243,803 |
| Equity per share (SEK) | 2.90 | 14.98 | 2.90 | 14.98 | 10.77 |
| Equity / assets ratio (%) | 69 | 84 | 69 | 84 | 81 |
| Average number of employees | 45 | 64 | 39 | 65 | 64 |
| Average number of employees in R&D | 4 | 19 | 8 | 20 | 18 |
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 relating 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 outstanding shares in the period before and after dilution respectively. Because the group is generating a loss, there is no dilution, despite the subscrip tion price being lower than the share price. |
|
| R&D expenses | The company's direct expenses for research and development. Expen ses 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. |
| R&D expenses as a percen tage of operating expenses |
R&D expenses divided by operating expenses, which include other ex ternal expenses, personnel expen ses, 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 equivalents | Cash and bank balances. | |
| Cash flow from operating 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 equivalents for the period excluding effective unrealized exchange rate gains and exchange rate losses. |
|
| Equity per share (SEK) | Equity 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 employees 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 research and development functions. |
Parent company's income statement, summary
| 2023 | 2022 | 2023 | 2022 | Full year | |
|---|---|---|---|---|---|
| SEK thousands | April-June | April-June | Jan-June | Jan-June | 2022 |
| Operating income etc. | |||||
| Net sales | 7,390 | 4,496 | 12,381 | 11,834 | 24,725 |
| Other operating income | 4 | 5 | 82 | 48 | 59 |
| Total operating income | 7,394 | 4,501 | 12,463 | 11,882 | 24,784 |
| Operating expenses | |||||
| Raw material and consumables | -3,113 | -730 | -3,948 | - 1,639 | -3,598 |
| Other external expenses | -12,828 | -14,301 | -27,168 | -39,797 | -61,700 |
| Personnel costs | -15,438 | -13,914 | -25,771 | -27,328 | -48,376 |
| Amortization of intangible and | |||||
| tangible fixed assets | -128,814 | -4,328 | -132,974 | -8,605 | -16,928 |
| Other operating expenses | -163 | -86 | -408 | -177 | -313 |
| Total operating expenses | -160,356 | -33,359 | -190,269 | -77,545 | -130,915 |
| Operating earnings/loss | -152,962 | -28,858 | -177,806 | -65,664 | -106,131 |
| Operating expenses | |||||
| Result from shares in group companies | -46,381 | 0 | -70,017 | 0 | -256,321 |
| Financial incomes | 14,622 | 18,829 | 16,918 | 23,690 | 47,271 |
| Financial expenses | 0 | -2 | 0 | -2 | -16,604 |
| Total financial items | -31,759 | 18,827 | -53,099 | 23,688 | -225,654 |
| Earnings/loss after financial items | -184,721 | -10,031 | -230,905 | -41,976 | -331,785 |
| Allocations | |||||
| Group contributions received | 0 | 0 | 0 | 0 | 638 |
| Total allocations | 0 | 0 | 0 | 0 | 638 |
| Earnings/loss before tax | -184,721 | -10,031 | -230,905 | -41,976 | -331,147 |
| Income tax | 0 | 0 | 0 | 0 | 0 |
| Earnings/loss for the period | -184,721 | -10,031 | -230,905 | -41,976 | -331,147 |
Parent company's comprehensive income, summary
| 2023 | 2022 | 2023 | 2022 | 2022 | |
|---|---|---|---|---|---|
| SEK thousands | April-June | April-June | Jan-June | Jan-June | Full year |
| Earnings/loss for the period | -184,721 | -10,031 | -230,905 | -41,976 | -331,147 |
| Other earnings/loss for the period | 0 | 0 | 0 | 0 | 0 |
| Comprehensive income for the period | -184,721 | -10,031 | -230,905 | -41,976 | -331,147 |
Parent company's balance sheet, summary
| 2023 | 2022 | 2022 | |
|---|---|---|---|
| SEK thousands Note |
June 30 | June 30 | Dec 31 |
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets 3,4,5 |
1,767 | 139,070 | 132,335 |
| Tangible fixed assets | 6,148 | 8,941 | 7,492 |
| Financial fixed assets | 328 | 328 | 328 |
| Total fixed assets | 8,243 | 148,339 | 140,155 |
| Current assets | |||
| Inventory | 0 | 1,268 | 1,546 |
| Receivables from Group companies | 685 | 198,660 | 0 |
| Current receivables | 2,983 | 2,999 | 684 |
| Prepaid expenses and accrued income | 3,348 | 2,367 | 6,006 |
| Cash and cash equivalents | 133,597 | 193,324 | 103,953 |
| Total current assets | 140,613 | 398,618 | 112,190 |
| TOTAL ASSETS | 148,856 | 546,957 | 252,345 |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity | 2,264 | 1,132 | 1,132 |
| Fund for development expenses | 0 | 111,250 | 105,323 |
| Total equity and liabilities | 2,264 | 112,382 | 106,455 |
| Non-restricted equity | |||
| Premium fund | 120,111 | 0 | 0 |
| Retained earnings including comprehensive income | 2,403 | 411,228 | 127,984 |
| Total non-restricted equity | 122,514 | 411,228 | 127,984 |
| Total equity | 124,778 | 523,610 | 234,439 |
| Current liabilities | |||
| Other liabilities | 24,078 | 23,347 | 17,906 |
| Total current liabilities | 24,078 | 23,347 | 17,906 |
| TOTAL EQUITY AND LIABILITIES | 148,856 | 546,957 | 252,345 |
Parent company's cash flow statement, summary
| 2023 | 2022 | 2022 | |
|---|---|---|---|
| SEK thousands | Jan-June | Jan-June | Full year |
| Operating activities | |||
| Operating earnings/loss | -177,806 | -28,858 | -106,131 |
| Adjustment for items not included in cash flow | 132,974 | 4,328 | 16,928 |
| Interest received | 1,238 | 133 | 744 |
| Interest paid | 0 | -2 | -2 |
| Tax paid | 0 | 0 | 0 |
| Cash flow from operating activities before changes in working capital |
-43,594 | -24,399 | -88,461 |
| Cash flow from changes in working capital | |||
| Change in inventory | 1,546 | -193 | 175 |
| Change in operating receivables | -54,663 | -21,406 | -78,346 |
| Change in operating liabilities | 6,173 | 2,582 | -7,814 |
| Cash flow from operating activities | -90,538 | -43,416 | -174,446 |
| Investment activities | |||
| Investment in intangible fixed assets | -1,061 | -91 | -368 |
| Investment in tangible fixed assets | 0 | -0 | -424 |
| Investment in financial fixed assets | 0 | 0 | 0 |
| Sale of fixed assets | 0 | 0 | 0 |
| Cash flow from investment activities | -1,061 | -91 | -792 |
| Financing activities | |||
| New share issue | 121,243 | 0 | 0 |
| Cash flow from financing activities | 121,243 | 0 | 0 |
| Cash flow for the period | 29,644 | -43,507 | -175,238 |
| Cash and cash equivalents at start of period | 103,953 | 236,831 | 279,191 |
| Cash and cash equivalents at period's end | 133,597 | 193,324 | 103,953 |
Notes
NOTE 1 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. The applied accounting principles are consistent with those applied in the 2022 annual report.
This interim report has been prepared in accordance with IAS 34 Interim.
New and amended standards adopted with effect from 2023 are not expected to have any significant impact on the Group's financial position.
NOTE 2 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.
Inventory
Inventory is reported by applying the first-in-first-out principle (FIFO). Raw materials and finished and half-finished products purchased are valued at the lower out of acquisition and net sales value. Manufactured finished and half-finished products are valued at the lower of the manufacturing cost of the goods (including a reasonable share of indirect manufacturing costs) and the net sales value.
When trading between Group companies, market conditions are applied. In the case of obsolescence and internal profits, the necessary provisions and eliminations are made.
Revenue recognition
Of this quarter's net sales, kSEK 351 refers to sales of test results. These contracts contain a performance commitment, which means carrying out tests on blood samples for the customers, i.e. the patient. The test result is sent to the patient immediately after the analysis has been carried out. Revenue recognition takes place when the test result has been sent, i.e. transferred to the clinicians, which means that revenue recognition takes place at a certain time.
Transactions with related parties
From time to time, board members undertake specific assignments outside the scope of regular board work, which are either decided by the AGM or by the Board of Directors.
In addition to salaries and other renumeration to executive management and board fees, according to a resolution by the AGM, during 2018, a consulting agreement was entered into with CB Ocean Capital AB for services performed by Immunovia's then chairman of the board and one of the largest owner Carl Borrebaeck regarding scientific and strategic support. The agreement has provided a quarterly compensation of SEK 41 thousand and will expire in Q3 2023 based on contractual notice period
Risks
lmmunovia 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 35 of the 2022 annual report.
Currency risk
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 scope of the company's operations currently means that net exposure in foreign currencies is limited. The company therefore does not have a currency hedging policy.
Interest risk in cash flow
Interest risk is the risk that the value of financial instruments will fluctuate due to changes in market interest rates. The Group currently only has interest-bearing financial assets in the form of bank deposits as well as interest-bearing liabilities in the form of leasing debt for premises.
Credit risk
Credit risk is the risk that a party in a transaction with a financial instrument cannot fulfill its commitment. The maximum exposure to credit risks regarding financial assets amounted to kSEK 145,043 (201,179) June 30, 2023.
Liquidity risk
The company is in a situation where operational costs are not covered by generated revenues, but requires external financing. With a cash position of MSEK 144, along with the expected effects of the ongoing reconstruction, the Board's assessment is that the company's continued operation based on current plans is financed through the end of 2024 or early 2025.
Parent company
To reflect managements view on the financial impact of market penetration and reimbursement in the US in the financial statements, it has been decided to write off the intercompany claim of 46 MSEK in Immunovia AB, which the parent company has on Immunovia Inc. Being an intercompany transaction, it will have no impact in the consolidated statements.
June 30, 2023 June 30, 2022 Dec 31, 2022 June 30, 2023 June 30, 2022 Dec 31, 2022 Opening cost 173,878 173,878 173,878 173,878 178,878 173,878 Investment 0 0 0 0 0 0 Sales and disposals -178,878 0 0 -178,878 0 0 Total 0 173,878 173,878 0 173,878 173,878 Opening amortization -19,662 -7,244 -7,244, -19,662 -7,244 -7,244, Amortization and impairment for the year -110,073 -6,209 -12,418 -110,073 -6,209 -12,418 Sales and disposals 129,736 0 0 129,736 0 0 Closing accumulated amortization 0 -13,453 -19,662 0 -13,453 -19,662 National and European subsidies of development expenditure Opening balance -44,142 -44,142 -44,142 -44,142 -44,142 -44,142 Deducted in the year 44,142 0 0 44,142 0 0 Total 0 -44,142 -44,142 0 -44,142 -44,142 Carrying amount 0 116,283 110,073 0 116,283 110,073 The Group Parent company
NOTE 3 CAPITALIZED DEVELOPMENT EXPENDITURE
Remaining depreciation period based on reported value Dec 31, 2022, was approximately 8.5 years.
During the second quarter of 2021, the development of the company's test for early detection of pancreatic cancer was completed, and with this also the capitalization of the development and the write-off of the capitalized costs began.
Impairment tests have been carried out continuously. Significant factors to assess have been cash flows for the next five years, growth beyond the forecast period and the weighted cost of capital.
With the decision to cease commercialization of the IMMray™ PanCan-d test, the uncertainties that existed regarding the impairment test established June 30, 2023, were confirmed. This has resulted in a full write-off of capitalized development costs.
NOTE 4 PATENTS
| The Group | Parent company | |||||
|---|---|---|---|---|---|---|
| June 30, 2023 |
June 30, 2022 |
Dec 31, 2022 |
June 30, 2023 |
June 30, 2022 |
Dec 31, 2022 |
|
| Opening cost | 24,121 | 23,815 | 23,815 | 24,121 | 23,815 | 23,815 |
| Investment | 35 | 167 | 368 | 35 | 167 | 368 |
| Sales and scrapping | -22,224 | 0 | -62 | -22,224 | 0 | -62 |
| Closing accumulated cost | 1,933 | 23,982 | 24,121 | 1,933 | 23,982 | 24,121 |
| Opening amortization | -2,707 | -1,549 | -1,549 | -2,707 | -1,549 | -1,549 |
| Amortization for the year | -665 | -579 | -1,158 | -665 | -579 | -1,158 |
| Sales and disposals | 2,179 | 0 | 0 | 2,179 | 0 | 0 |
| Closing accumulated amortiza tion |
-1,192 | -2,128 | -2,707 | -1,192 | -2,128 | -2,707 |
| Opening impairment | -598 | -598 | -598 | -598 | -598 | -598 |
| Impairment for the year | -19 446 | 0 | 0 | -19 446 | 0 | 0 |
| Sales and disposals | 20 044 | -598 | -598 | 20 044 | -598 | -598 |
| Carrying amount | 741 | 21,256 | 20,816 | 741 | 21,256 | 20,816 |
For patents, the basis for depreciation is 1.9 (24.1) MSEK. Remaining patents are linked to the basis for royalty income and the remaining amortization period of 5 years is made up of the lifespan of the patent.
Considering the write-down of capitalized development costs (note 3), this has resulted in write-down of related patents.
NOTE 5 LICENSES
| The Group | Parent company | |||||
|---|---|---|---|---|---|---|
| June 30, 2023 |
June 30, 2022 |
Dec 31, 2022 |
June 30, 2023 |
June 30, 2022 |
Dec 31, 2022 |
|
| Opening cost | 3,911 | 3,675 | 3,675 | 2,146 | 2,146 | 2,146 |
| Investment | 1,026 | 0 | 0 | 1026 | 0 | 0 |
| Sales and scrapping | -1718 | 0 | 0 | -1,718 | 0 | 0 |
| Translation differences for the year | 64 | 175 | 235 | 0 | 0 | 0 |
| Closing accumulated cost | 3,283 | 3,851 | 3,911 | 1,454 | 2,146 | 2,146 |
| Opening amortization | -1,224 | -689 | -689 | -701 | -529 | -529 |
| Amortization for the year | -245 | -238 | -500 | -86 | -86 | -172 |
| Sales and disposals | 359 | 0 | 359 | 0 | 0 | |
| Translation differences for the year | 0 | 0 | -34 | 0 | 0 | 0 |
| Closing accumulated amortization | -1,110 | -928 | -1,224 | -428 | -615 | -701 |
| Impairment for the year | -1,359 | 0 | 0 | -1,359 | 0 | 0 |
| Sales and disposals | 1,359 | 0 | 0 | 1,359 | 0 | 0 |
| Carrying amount | 2,173 | 2,923 | 2,687 | 1,026 | 1,531 | 1,445 |
| Closing amount of intangible assaets note 3-5 |
2,914 | 140,462 | 133,597 | 1,767 | 139,070 | 132,335 |
For licenses, the basis for depreciation is 3.2 (3.9) MSEK. Carrying value for licenses amounts to 2.2 MSEK and refers to the handling of patient samples. Considering the write-down of capitalized development costs (note 3), this has resulted in write-down of related licenses. The depreciation period for the remaining licenses is 3-5 years.
NOTE 6 INTEREST BEARING LIABILITIES
Interest-bearing liabilities mainly consist of leasing agreements for premises in Sweden and the US. Reduced leasing debt refers to, in addition to amortization, a re-negotiated agreement for premises in the US. The right-of-use asset (tangible fixed assets) has decreased by the corresponding amount.
NOTE 7 OTHER LIABILITIES
Other liabilities have been affected by termination and severance pay.
OTHER INFORMATION
Review
This interim report has not been reviewed by the company's auditors.
Financial calendar
Q3 interim report 2023, Thursday November 9, 2023 Financial statement 2023, Wednesday February 21, 2024
Contact information:
lmmunovia AB (publ), Medicon Village, Scheelevägen 8, 223 63 Lund, Sweden Tel: +46 46 275 60 00 Email: [email protected] Web: www.immunovia.com
For further information please contact
Jeff Borcherding, CEO and President • [email protected]
Karin Almqvist Liwendahl, CFO • [email protected]
The information in this report 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, at 08:30 am CET on August 30, 2023.
Conference call
Immunovia will hold a webcast tele conference at 15:00 CET on August 30, with Jeff Borcherding, CEO and President and Karin Almqvist Liwendahl, CFO.
To take part of the presentation, please dial one of the numbers or watch via the web link below.
Telephone numbers and webcast Sweden: +46 (0)8 5051 0031 United Kingdom: +44 (0) 207 107 06 13 United States: +1 (1) 631 570 56 13
Link to the webcast: https://link.edgepilot.com/s/55898572/0v6JeODzJ0OaR5rjK1wJ1g?u=https://creo-live.creomediamanager.com/0916b506-5ec6-4678-b83a-ab16e40022e3
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 company and the companies making up the Group face.
Lund August 30, 2023
Peter Høngaard Andersen Chairman of the board
Hans Johansson Board member
Martin Møller Board member Michael Löfman Board member
Jeff Borcherding CEO & President
Glossary
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.
Antibodies – Antibodies, or immuglobulins, are a type of protein used by the body´s immune system to detect and identify foreign substances such as viruses, bacteria or parasites.
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.
CAP - College of American Pathologists. The CAP has deemed status under CLIA to accredit laboratories performing testing on specimens from human beings or animals, using methodologies and clinical application within the expertise of the program. Laboratories must be appropriately licensed to perform testing when required by law.
CLIA - Clinical Laboratory Improvement Amendments. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to ensure quality laboratory testing. All clinical laboratories must be properly certified to receive Medicare or Medicaid payments.
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.
NOD type 2 – New Onset Diabetes type 2.
NPV– Negative Predictive Value.
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.
PDAC– Pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer.
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.
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.
Resectable – Able to be removed by surgery.
Retrospective study – A study in which the focus is on something 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.
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.
lmmunovia in brief
Immunovia AB is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer.
Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer.
USA is the world's largest market for detection of pancreatic cancer. The company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm.
For more information, please visit www.immunovia.com
It is estimated that early detection of pancreatic cancer would increase the five-yearsurvival rate up to 50 percent.
I
IMMUNOVIA AB EARLY DETECTION Phone: +46 (0)46-275 60 00 [email protected]
www.immunovia.com
Scheelevägen 8, Medicon Village
223 63 Lund, Sweden