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Immunovia
Quarterly Report • Feb 21, 2024
3061_10-k_2024-02-21_5900f22b-9de3-4daf-9122-953327380e0d.pdf
Quarterly Report
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2023 FULL YEAR REPORT
October- December 2023
- Net sales, which for the quarter only included royalties, amounted to kSEK 155 (502).
- Net earnings were MSEK -49 (-67) and earnings per share before and after dilution were SEK -1.08 (-2.97).
- Cash Flow from operating activities amount MSEK -28 (-51).
- Cash and equivalents at the end of the period amounted to MSEK 77 (106).
- On October 3, the Company announced that the Nomination Committee had been appointed to consist of the following persons who together represent 7,52 percent of the total number of outstanding shares and votes in the company as of September 30, 2023: Sara Ek, Carl Borrebaeck and Mats Leifland.
- On October 27, the Company gave notice that an extraordinary general meeting was to take place on November 21.
- On November 7, the Company announced that the discovery phase of next generation test was successfully completed.
- On November 21, the Company announced that Melissa Farina and Valerie Bogdan-Powers had been elected as new board members at the extraordinary general meeting. An adoption of an equity incentive program for the Company's management and key personnel along with an equity incentive program for the Company's board of directors were resolved.
Significant events after the period
• On January 31, the Company announced that Norma Alonzo Palma had been appointed as the new Vice President of Clinical and Medical Affairs.
"I am proud to report on the transformation Immunovia accomplished in 2023. We have made substantial and rapid progress in developing our next-generation test. We have new leadership and a significantly smaller, more agile, and more productive organization. We have leveraged external partnerships to secure expertise and increase productivity and are exploring commercial partnerships to be ready for marketing and selling our next-generation test."
Jeff Borcherding, CEO and President, Immunovia AB
Key indicators
| SEK thousand unless otherwise stated | 2023 Oct-Dec |
2022 Oct-Dec |
2023 Full year |
2022 Full year |
|---|---|---|---|---|
| Net sales | 155 | 502 | 1,575 | 1,145 |
| Operating earnings/loss | -23,406 | -51,080 | -296,460 | -191,150 |
| Earnings before tax | -49,020 | -67,321 | -309,438 | -168,092 |
| Net earnings | -49,020 | -67,321 | -309,438 | -168,092 |
| Earnings per share before dilution (SEK) | -1,08 | -2.97 | -7,95 | -7.43 |
| Earnings per share after dilution (SEK) | -1,08 | -2.97 | -7,95 | -7.43 |
| Equity ratio (%) | 68 | 81 | 68 | 81 |
| Number of shares at the end of the period | 45,287,498 | 22,631,581 | 45,287,498 | 22,631,581 |
CEO's comments
The new Immunovia is taking shape
I am proud to report on the transformation Immunovia accomplished in 2023. We have made substantial and rapid progress in developing our next-generation test. We have new leadership and a significantly smaller, more agile, and more productive organization. We have leveraged external partnerships to secure expertise and increase productivity and are exploring commercial partnerships to be ready for marketing and selling our next-generation test. We transitioned from the proprietary IMMray platform to leading lab platforms to lower costs and move faster. At the same time, Immunovia's legacy assets—our relationships with top researchers and our industry-leading biobank of blood samples—have propelled our progress. Our interactions with key opinion leaders, clinicians, and individuals at high risk for pancreatic cancer have proven there is a robust demand for an early detection blood test.
In 2024 our key priorities are to finalize development of our new test, prove its value in clinical studies, and secure the resources and commercial partnerships to bring our test to the market in 2025. The size of the pancreatic cancer surveillance market, the growing need for early detection and the promise of our R&D efforts fuel optimism as we confront the realities of our resource challenges.
The market for early detection of pancreatic cancer in high-risk individuals is large and growing, and there is proven market demand for a simple blood test
Immunovia is targeting a very large total addressable market. We estimate that over 1.8 million people in the U.S. alone are at high-risk for pancreatic cancer. Our immediate focus is the more than 600,000 individuals at high risk due to a family history of pancreatic cancer and genetic mutations. Of these, more than 80% are not undergoing regular surveillance due to a lack of awareness, poor compliance with imaging, limited access to high-risk surveillance centers, and a general dissatisfaction with current surveillance methods. A simple blood test to detect pancreatic cancer can overcome these barriers, detect pancreatic cancer earlier, and save lives.
The market for pancreatic cancer surveillance is growing and pancreatic cancer cases are rising, putting more family members at risk. Growth in genetic testing is identifying more people with hereditary mutations at risk for pancreatic cancer. A blood test for pancreatic cancer is a scalable solution to meet the increasing need for surveillance.
Our experience in recent years makes it clear that there is a large and significant unmet need in early detection of pancreatic cancer. We have long believed in this potential based on our deep collaborations with key opinion leaders in pancreatic cancer. The adoption of the IMMray™ PanCan-d test at leading academic institutions and high-risk surveillance centers reinforced our conviction that people at risk for pancreatic cancer—and their clinicians—have a strong desire for a simple, accurate blood test for early detection. The IMMray™ PanCan-d test paved the way for our next-generation test.
Immunovia has truly unique legacy assets, expertise, and partnerships crucial for driving successful product development faster and more efficiently than ever before
Our access to leading scientists
Immunovia's long history in early detection is propelling the company into the future. We have strong, long-standing collaborative relationships with the top clinicians and researchers in pancreatic cancer. These physicians inform our product development and clinical study designs. We have defined the target product profile for our next-generation test—work carried out in close collaboration with key clinicians. In January 2024 we met with our scientific advisory board, which provided expert counsel on several crucial questions regarding our next-generation test. We will also partner with leading researchers to conduct clinical studies of our test, often at a much lower cost because the research is part of a funded study. For example, we will be able to research test performance in a study funded by the National Institutes of Health (NIH) in the U.S., which is being led by two of our advisors, Professors Diane Simeone and Randy Brand.
Once our test is ready for launch, these key opinion leaders will be important voices to educate other physicians about the test. These relationships with KOLs are a unique asset that Immunovia has thanks to the work done over the last 4 to 5 years in the field.
Our unique sample bank
Through our extensive research, we have accumulated a large and valuable biobank of nearly 8,500 blood samples. We have over 850 blood samples from patients with pancreatic cancer; of these, nearly 400 samples are rare stage 1 and 2 PDAC cases. The biobank includes a rich assortment of individuals with a family history of pancreatic cancer, genetic mutations, diabetes, pancreatitis, and other risk factors. This expansive biobank is driving rapid development of the next-generation test. It will also enable Immunovia to rapidly conduct clinical studies of our new test.
Our development partner
Finally, our development partnership with Onconetix (formerly Proteomedix) continues to pay dividends. The expertise of the Onconetix team in developing and refining protein-based assays has been a strong complement to Immunovia's expertise in pancreatic cancer testing.
We have leveraged our legacy assets and strong partnerships to develop our next-generation test in a frac-tion of the time it took to develop IMMray™ PanCan-d
We have made tremendous advancements over the last 9 months in the development of Immunovia's next-generation test for early detection of PDAC. We designed and conducted the largest study of proteins in pancreatic cancer, screening over 3.000 antibodies to identify 15 very promising proteins to detect PDAC. Patent attorneys conducted a freedom to operate analysis that found no risks in commercializing a test with these markers. Immunovia partnered with the protein assay experts at Onconetix to identify and refine assays for the 15 most promising protein biomarkers. With these assays, we will finalize the design of the next-generation test and conduct the initial clinical verification over the next two months. In just over a year, we will have developed and locked the algorithm for the next generation test. By contrast, this process took many years with IMMray™ PanCan-d.
Once we have completed test development, an analytical validation study will follow to confirm that we are accurately measuring the target proteins. Finally, we will complete a clinical validation study by year-end 2024 to confirm the sensitivity and specificity of our new test. In parallel, we are designing and preparing for additional clinical studies in 2025 to support reimbursement.
The new Immunovia is rapidly taking shape. We have transformed the company to focus on the success of the next-generation test.
Starting in July 2023, we made several significant changes to support the development of Immunovia's new test. We removed the IMMray™ PanCan-d test from the market, enabling us to dramatically reduce our burn rate. We transitioned from the high-cost, proprietary IMMray platform to the newer, innovative Olink platform for protein discovery. We transitioned to ELISA, a widely used diagnostic testing platform that will decrease fixed costs as well as the cost per test, increase reliability, reduce scrap, and increase scalability. These changes enabled us to reduce staffing by 80%, and we ended 2023 with just eleven employees. With these changes, we have decreased our monthly cash burn rate with 50-60 %.
Importantly, we completed these significant changes without impacting the rapid progress of developing our new test. Further, we were able to maintain and even enhance our relationships with key researchers, clinicians, and advocacy groups despite the changes.
We are focused on the efforts required to achieve our milestones and bring the new test to market
We have reduced our burn rate to below 10 MSEK per month and are focused on the development and clinical study of our exciting next-generation test. In parallel, it is critical that we secure the resources to fuel R&D, clinical studies, and future commercial efforts. The company is currently funded into the fourth quarter of 2024. We are also negotiating to reduce or eliminate long-term financial commitments linked to the now-discontinued IMMray™ PanCan-d product. The Immunovia board of directors and management team are actively evaluating multiple financial and strategic options, including exploring strategic transactions such as a merger or sale of the company, raising capital, and selling assets. We face a challenging financial market. Nonetheless, we believe we can secure the strategic resources needed.
The new Immunovia is committed to bringing the next-generation test to market and achieving a financial return for shareholders
Since I became CEO in April 2023, I have been struck by the commitment and passion of our employees, our board of directors, and our collaborators. This group is incredibly devoted to launching a blood test for early detection that meets the needs of individuals at risk and the clinicians who treat them. This devotion has fuelled tremendous progress in the face of significant change and obstacles. We will do all we can to secure additional funding, finalize product development, prove the accuracy and value of the new test, and secure a commercial partner to fuel a successful commercial launch. On behalf of every team member, I extend our sincere thanks to you, our stockholders, for your continued support. I am grateful to lead this extraordinary company. We are committed to delivering on the promise of the new Immunovia—both for individuals at risk for pancreatic cancer and for our shareholders.
February 21, 2024 Jeff Borcherding President & CEO, Immunovia AB
5
Table of contents
| Group's performance over the period 6 |
|---|
| Share information 7 |
| Incentive scheme 9 |
| Consolidated income statement in summary 10 |
| Consolidated comprehensive income in summary 10 |
| Consolidated financial position in summary 11 |
| Change in consolidated equity in summary 12 |
| Consolidated cash flow statement in summary 13 |
| Consolidated key indicators 14 |
| Definitions 15 |
| Parent company's income statement in summary 16 |
| Parent company's comprehensive income in summary 16 |
| Parent company's financial position in summary17 |
| Parent company's cash flow statement in summary 18 |
| Notes 19 |
| Glossary 26 |
| Immunovia in brief 28 |
About the report
This information was submitted for publication on Februay 21, 2024, 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 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
- [email protected]
Karin Almqvist Liwendahl, CFO
october-december 2023
The Group's performance over the period
Net sales
Net sales for Q4, which only included royalties, amounted to kSEK 155 (502). For the period January to December 2023, net sales amounted to kSEK 1,575 (1,145), of which kSEK 800 (468) consisted of sales of tests and kSEK 775 (677) were royalties.
Earnings
Net earnings for Q4 amounted to kSEK -49,020 (-67,321). The primary reason for the decrease in net loss is the significant downsizing of the business and reduction of staffing.
For the year 2023, the net profit amounted to kSEK -309,438 (-168,092). The change in net income was mainly due to the write-down of development costs made during 2023 MSEK -141. and that the financial net for 2023 is MSEK -36 lower compared to last year.
Other external costs and personnel costs decreased during the fourth quarter by kSEK 24,387 compared to the corresponding period last year due to the organization and operational activities being scaled back.
Research & Development
Total R&D cost for Q4 2023 amounted to MSEK 4.1 (12,8), which corresponded to 17 percent (24) of the Group's total operating expenses.
Financing and cash flow
Cash flow from operating activities during the Q4 2023 amounted to kSEK -28,489 (-51,205). Cash flow from January to December 2023 amounted to kSEK -147 057 (-175 582).
Cash and cash equivalents as of December 31, 2023 amounted to kSEK 76,788 (106,041).
Equity at the end of the period amounted to kSEK 66,991 (243,803) and the equity/assets ratio was 68 percent (81).
Going concern
With a cash balance of 77 MSEK, Immunovia is able to secure operations based on current plans into the fourth quarter 2024 but will need capital to finish 2024 and fund operations in 2025. The company has evaluated the risks and the possibilities to secure financing and see a clear path forward.
Investments
In Q4, intangible assets totalling kSEK 0 (76) were acquired, consisting of capitalized development expenditure of kSEK 0 (0) and patents kSEK 0 (76).
During the period January to December 2023, investments in intangible fixed assets amounted to kSEK 1,061 (368) consisting of capitalized development expenditure of kSEK 0 (0), patents kSEK 35 (368) and licenses kSEK1,026 (0).
Investments in tangible fixed assets in the form of equipment were made during Q4 2023 of kSEK 0 (0). For the period January to December 2023 investments in tangible fixed assets amounted to kSEK 0 (1,256).
During the quarter the subsidiary Immunovia Dx Laboratories AB was divested with no impact on earnings. No other financial tranactions were made during the period January to December 2023.
Employees
The average number of employees during the Q4 2023 was 18 (64) and at the end of the period the number of employees was 11 (64).
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 December 31, 2023
| Shareholders | No. of shares | Share (capital and votes) |
|---|---|---|
| Avanza Pension | 4,713,411 | 10.41% |
| Carl Borrebaeck | 1,709,900 | 3.78% |
| Caceis Bank, Switzerland Branch, WBIMY | 1,319,706 | 2.91% |
| Nordnet Pensionsförsäkring AB | 938,127 | 2.07% |
| Vincent Saldell | 924,000 | 2.04% |
| Mats Ohlin | 848,950 | 1.87% |
| Sara Andersson Ek | 848,907 | 1.87% |
| Christer Wingren | 748,525 | 1.65% |
| Åhlandsbanken ABP (Finland), Svensk filial | 692,027 | 1.53% |
| EFG BANK/GENEVA | 481,387 | 1.06% |
| Ten largest owners | 13,224,940 | 29.20% |
| Others | 32,062,558 | 70.80% |
| 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 four outstanding incentive programs comprising 1,055,309 options with the right to subscribe for 1,055,309 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.
Equity incentive program
At an extraordinary general meeting, November 21, 2023, it was decided to adopt an equity incentive program for the Company's management and key personnel, including a resolution to issue not more than 2,597,234 warrants to ensure the delivery of shares to the participants and for hedging of social security costs. The incentive program entails that the participants will be granted options which entitle the holder to purchase shares in the company at a pre-determined exercise price corresponding to 100 percent of the volume-weighted average price of the Immunovia share on Nasdaq Stockholm during the five (5) trading days preceding the granting date. It was also decided to adopt an equity incentive program for the Company's board of directors, including a resolution to issue not more than 649,309 warrants to ensure the delivery of shares to the participants and for hedging of social security costs. The incentive program entails that the participants will be granted options which entitle the holder to purchase shares in the company at a pre-determined exercise price corresponding to 100 percent of the volume-weighted average price of the Immunovia share on Nasdaq Stockholm during the five (5) trading days preceding the granting date. Of the two programs decided only the Board ESOP has been allocated.
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 | 126,000 | 88.69 | 6,300.00 | |
| Alternative cash based incentive pro gram 2020/2024 |
Sep 23, 2020 | Jun 1, 2024 – Jun 30, 2024 | 39,812 | |||
| Board ESOP | Dec 28, 2023 | Until December 28, 2033 | 649,309 | 32,465.45 | ||
| Total | 1,055,309 | 52,765,45 | 39,812 |
Consolidated income statement, summary
| 2023 | 2022 | 2023 | 2022 | |
|---|---|---|---|---|
| SEK thousands | Oct -Dec | Oct -Dec | Full year | Full year |
| Operating income etc | ||||
| Net sales | 155 | 502 | 1,575 | 1,145 |
| Other operating income | 55 | 11 | 227 | 59 |
| Total operating income | 210 | 513 | 1,802 | 1,204 |
| Operating expenses | ||||
| Raw materials and consumables | 0 | -925 | -6,682 | -4,211 |
| Other external expenses | -11,169 | -22,795 | -68,723 | -77,749 |
| Personnel costs | -8,868 | -21,629 | -79,580 | -85,222 |
| Amortization and write-down of tangible and | ||||
| intangible assets | -2,437 | -6,231 | -141,719 | -24,913 |
| Other operating expenses | -1,143 | -12 | -1,558 | -259 |
| Total operating expenses | -23,616 | -51,592 | -298,262 | -192,354 |
| Operating earnings/loss | -23,406 | -51,079 | -296,460 | -191,150 |
| Profit/loss from financial items | ||||
| Financial income | -10,650 | 745 | 6,278 | 41,259 |
| Financial expenses | -14,965 | -16,987 | -19,257 | -18,201 |
| Total financial items | -25,614 | -16,242 | -12,978 | 23,058 |
| Earnings/loss after financial items | -49,020 | -67,321 | -309,438 | -168,092 |
| Income tax | 0 | 0 | 0 | 0 |
| Earnings/loss for the period | -49,020 | -67,321 | -309 438 | -168,092 |
| Earnings per share before dilution (SEK) | -1.08 | -2.97 | -7.95 | -7.43 |
| Earnings per share after dilution (SEK) | -1.08 | -2.97 | -7.95 | -7.43 |
| Average number of shares | 45,287,498 | 22,631,581 | 38,931,255 | 22,631,581 |
| Number of shares at the end of the period | 45,287,498 | 22,631,581 | 45,287,498 | 22,631,581 |
Consolidated comprehensive income, summary
| 2023 | 2022 | 2023 | 2022 | |
|---|---|---|---|---|
| SEK thousands | Oct-Dec | Oct-Dec | Full year | Full year |
| Earnings/loss for the period | -49,020 | -67,321 | -309,438 | -168,092 |
| Items that may be reclassified later in the income statement |
||||
| Exchange rate differences for foreign net | ||||
| investment | 22,789 | 14,561 | 11,383 | -22,647 |
| Other earnings/loss for the period | 22,789 | 14,561 | 11,383 | -22,647 |
| Comprehensive income for the period | -26,231 | -52,760 | -298,055 | -190,739 |
Consolidated financial position, summary
| 2023 | 2022 | ||
|---|---|---|---|
| SEK thousands | Note | Dec 31 | Dec 31 |
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 3,4,5 | 2,547 | 133,597 |
| Tangible fixed assets | 15,117 | 47,877 | |
| Financial fixed assets | 506 | 3,500 | |
| Total fixed assets | 18,170 | 184,974 | |
| Current assets | |||
| Inventory | 0 | 2,016 | |
| Accounts receivable | 146 | 253 | |
| Other short term receivables | 3,577 | 7,305 | |
| Cash and cash equivalents | 76,788 | 106,041 | |
| Total current assets | 80,511 | 115,615 | |
| TOTAL ASSETS | 98,681 | 300,589 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Share capital | 2,264 | 1,132 | |
| Other contributed capital | 1,136,480 | 1,016,369 | |
| Translation reserve | -12,923 | -24,306 | |
| Retained earnings incl. total comprehensive income | -1,058,830 | -749,392 | |
| Total equity | 66,991 | 243,803 | |
| Long-term liabilities | |||
| Interest-bearing liabilities | 6 | 1,787 | 32,700 |
| Total long-term liabilities | 1,787 | 32,700 | |
| Current liabilities | |||
| Interest-bearing liabilities | 6 | 8,478 | 4,874 |
| Other liabilities | 7 | 21,425 | 19,212 |
| Total current liabilities | 29,903 | 24,086 | |
| TOTAL EQUITY AND LIABILITIES | 98,681 | 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 | -22,648 | -168,092 | -190,740 | ||
| Transactions with owners in their capacity as owners |
|||||
| Recived as warrants premium | 639 | 639 | |||
| Closing balance December 31, 2022 | 1,132 | 1,016,369 | -24,306 | -749,392 | 243,803 |
| Comprehensive income for the period | 11,383 | -309,438 | -298,055 | ||
| 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 December 31, 2023 | 2,264 | 1,136,480 | -12,923 | -1,058,830 | 66,991 |
Consolidated cash flow statement, summary
| 2023 | 2022 | 2023 | 2022 | |
|---|---|---|---|---|
| SEK thousands | Oct-Dec | Oct-dec | Full year | Full year |
| Operating activities | ||||
| Operating earnings/loss | -23,406 | -51,080 | -296,459 | -191,150 |
| Adjustment for items not included in cash flow | 1,803 | 5,595 | 140,522 | 23,471 |
| Interest received | 706 | 270 | 2,912 | 745 |
| Interest paid | -248 | -280 | -1,166 | -1,494 |
| Tax paid | 0 | 0 | 0 | 0 |
| Cash flow from operating activities before changes in working capital |
-21,145 | -45,495 | -154,191 | -168,428 |
| Cash flow from changes in working capital | ||||
| Change in inventory | -42 | -785 | 1,995 | 438 |
| Change in operating receivables | 3,025 | 444 | 4,730 | 298 |
| Change in operating liabilities | -10,327 | -5,369 | 409 | -7,890 |
| Cash flow from operating activities | -28,489 | -51,205 | -147,057 | -175,582 |
| Investment activities | ||||
| Investment in intangible assets | 0 | -76 | -1,061 | -368 |
| Investment in tangible assets | 0 | 0 | 0 | -1,256 |
| Investment in financial fixed assets | 0 | 0 | 0 | 0 |
| Sale of fixed assets | 1,329 | 0 | 1,329 | 0 |
| Other long term receivables | -618 | 0 | 2,929 | 0 |
| Cash flow from investment activities | 711 | -76 | 3,197 | -1,624 |
| Financing activities | ||||
| Amortization of leasing liability | -1,643 | -1,548 | -6,500 | -5,746 |
| New share issue | 0 | 0 | 121,243 | 0 |
| Received warrants premiums | 0 | 309 | 0 | 639 |
| Cash flow from financing activities | -1,643 | -1,239 | 114,743 | -5,107 |
| Cash flow for the period | -29,421 | -52,520 | -29,117 | -182,313 |
| Cash and cash equivalents at start of period | 106,677 | 158,839 | 106,041 | 287,406 |
| Exchange rate difference in cash and cash | ||||
| equivalents | -468 | -278 | -136 | 948 |
| Cash and cash equivalents at end of period | 76,788 | 106,041 | 76,788 | 106,041 |
Consolidated key indicators
| 2023 | 2022 | 2021 | 2020 | 2019 | |
|---|---|---|---|---|---|
| Full year | Full year | Full year | Full year | Full year | |
| Operating earnings/loss (SEK 000) | -296,460 | -191,150 | -166,628 | -134,343 | -114,248 |
| Earnings/loss for the year (SEK 000) | -309,438 | -168,092 | -155,966 | -146,033 | -114,521 |
| Earnings per share before dilution (SEK) | -7.95 | -7.43 | -6.89 | -6.84 | -5.85 |
| Earnings per share after dilution (SEK) | -7.95 | -7.43 | -6.89 | -6.84 | -5.85 |
| R&D expenses (SEK 000) | -28,207 | -47,902 | -42,850 | -48,078 | -34,273 |
| R&D expenses as percentage of operating expenses (%) |
17 | 25 | 24 | 29 | 26 |
| Cash and cash equivalents at the period's end (SEK 000) |
76,788 | 106,041 | 287,406 | 468,462 | 263,345 |
| Cash flow from operating activities (SEK 000) | -147,057 | -175,582 | -152,648 | -120,704 | -91,952 |
| Cash flow for the period (SEK 000) | -28,489 | -182,313 | -181,743 | 205,918 | -122,797 |
| Equity (SEK 000) | 66,991 | 243,803 | 433,903 | 599,403 | 357,604 |
| Equity per share (SEK) | 1.48 | 10.77 | 19.17 | 26.49 | 18.19 |
| Equity / assets ratio (%) | 68 | 81 | 88 | 91 | 85 |
| Average number of employees | 32 | 64 | 67 | 63 | 48 |
| Average number of employees in R&D | 7 | 18 | 23 | 21 | 19 |
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 | |
|---|---|---|---|---|
| SEK thousands | Oct -Dec | Oct-Dec | Full year | Full year |
| Operating income etc. | ||||
| Net sales | 179 | 4,804 | 12,977 | 24,725 |
| Other operating income | 55 | 4 | 228 | 59 |
| Total operating income | 234 | 4,808 | 13,205 | 24,784 |
| Operating expenses | ||||
| Raw material and consumables | 0 | -895 | -3,948 | -3,598 |
| Other external expenses | -10,122 | -13,021 | -51,321 | -61,700 |
| Personnel costs | -4,360 | -10,266 | -37,309 | -48,376 |
| Amortization and write-down of intan | ||||
| gible and tangible fixed assets | -630 | -4,160 | -134,186 | -16,928 |
| Other operating expenses | 92 | -12 | -389 | -313 |
| Total operating expenses | -15,020 | -28,354 | -227,152 | -130,915 |
| Operating earnings/loss | -14,786 | -23,546 | -213,948 | -106,131 |
| Operating expenses | ||||
| Result from shares in group companies | 19,141 | -256,321 | -75,858 | -256,321 |
| Financial incomes | -8,229 | 2,577 | 12,130 | 47,271 |
| Financial expenses | -14,716 | -16,602 | -15,074 | -16,604 |
| Total financial items | -3,804 | -270,346 | -78,802 | -225,654 |
| Earnings/loss after financial items | -18,591 | -293,892 | -292,750 | -331,785 |
| Allocations | ||||
| Group contributions received | 0 | 638 | 0 | 638 |
| Total allocations | 0 | 638 | 0 | 638 |
| Earnings/loss before tax | -18,591 | -293,254 | -292,750 | -331,147 |
| Income tax | 0 | 0 | 0 | 0 |
| Earnings/loss for the period | -18,591 | -293,254 | -292,750 | -331,147 |
Parent company's comprehensive income, summary
| 2023 | 2022 | 2023 | 2022 | |
|---|---|---|---|---|
| SEK thousands | Oct-dec | Oct-Dec | Full year | Full year |
| Earnings/loss for the period | -18,591 | -293,254 | -292,750 | -331,147 |
| Other earnings/loss for the period | 0 | 0 | 0 | 0 |
| Comprehensive income for the period | -18,591 | -293,254 | -292,750 | -331,147 |
Parent company's balance sheet, summary
| 2023 | 2022 | |
|---|---|---|
| SEK thousands | Dec 31 | Dec 31 |
| ASSETS | ||
| Fixed assets | ||
| Intangible fixed assets | 1,639 | 132,335 |
| Tangible fixed assets | 3,764 | 7,492 |
| Financial fixed assets | 303 | 328 |
| Total fixed assets | 5,706 | 140,155 |
| Current assets | ||
| Inventory | 0 | 1,546 |
| Accounts recveivable | 146 | 0 |
| Receivables from Group companies | 660 | 0 |
| Current receivables | 782 | 684 |
| Prepaid expenses and accrued income | 2,203 | 6,006 |
| Cash and cash equivalents | 71,090 | 103,953 |
| Total current assets | 74,881 | 112,190 |
| TOTAL ASSETS | 80,587 | 252,345 |
| EQUITY AND LIABILITIES | ||
| Equity Restricted equity |
2,264 | 1,132 |
| Fund for development expenses | 0 | 105,323 |
| Total equity and liabilities | 2,264 | 106,455 |
| Non-restricted equity | ||
| Premium fund | 0 | 0 |
| Retained earnings including comprehensive income | 60,669 | 127,984 |
| Total non-restricted equity | 60,669 | 127,984 |
| Total equity | 62,933 | 234,439 |
| Current liabilities | ||
| Other liabilities | 17,654 | 17,906 |
| Total current liabilities | 17,654 | 17,906 |
| TOTAL EQUITY AND LIABILITIES | 80,587 | 252,345 |
Parent company's cash flow statement, summary
| 2023 | 2022 | |
|---|---|---|
| SEK thousands | Full year | Full year |
| Operating activities | ||
| Operating earnings/loss | -213,948 | -106,131 |
| Adjustment for items not included in cash flow | 134,181 | 17,567 |
| Interest received | 2,880 | 744 |
| Interest paid | -5 | -3 |
| Tax paid | 0 | 0 |
| Cash flow from operating activities before changes in working capital |
-76,892 | -87,823 |
| Cash flow from changes in working capital | ||
| Change in inventory | 1,546 | 175 |
| Change in operating receivables | -78,801 | -78,984 |
| Change in operating liabilities | -227 | -7,814 |
| Cash flow from operating activities | -154,374 | -174,446 |
| Investment activities | ||
| Investment in intangible fixed assets | -1,061 | -368 |
| Investment in tangible fixed assets | 0 | -424 |
| Investment in financial fixed assets | 0 | 0 |
| Sale of fixed assets | 1,329 | 0 |
| Cash flow from investment activities | 268 | -792 |
| Financing activities | ||
| New share issue | 121,243 | 0 |
| Cash flow from financing activities | 121,243 | 0 |
| Cash flow for the period | -32,863 | -175,238 |
| Cash and cash equivalents at start of period | 103,953 | 279,191 |
| Cash and cash equivalents at period's end | 71,090 | 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 finacial reporting.
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
Net sales for the fourth quarter relates only to royalties.
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.
Risks
Through its operations, Immunovia is exposed to both operational and financial risks. The following risks and uncertainty factors may have a negative impact on the Company's operations, financial position and/or results. The company's risks are also described in the Annual Report 2022, page 35.
Operational risks
Risks related to Immunovia's operations and industry include risks related to the development of new tests, outcome of studies and validations, dependence on collaboration partners, suppliers and other third parties, risks related to commercialization, market acceptance and reimbursement, and the competitive situation on the market. The board continually monitors the development of ongoing projects and decisions are made based on the Company's current risk profile
Currency risks
The Company operates both nationally and internationally, which results in exposure to currency exchange rate fluctuations mainly related to USD, CHF and EUR. Currency risk relates to future business transactions and assets and liabilities on the balance sheet. The net exposure in foreign currencies is limited based on current operations, so the company does not engage in currency hedging.
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 77,296 (163,060) December 31, 2023.
Liquidity risk and going concern
With a cash balance of 77 MSEK, Immunovia is able to secure operations based on current plans into the fourth quarter 2024 but will need capital to finish 2024 and fund operations in 2025. The company has evaluated the risks and the possibilities to secure financing and see a clear path forward.
Parent company
To reflect management's 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, to continuously write down the receivables arising from the parent company's financing to the subsidiary Immunovia Inc. The effect of the results for the financial year 2023, as of December 31, amounts to MSEK 76. Being an intercompany transaction, it will have no impact in the consolidated statements.
| The Group | Parent company | |||
|---|---|---|---|---|
| Dec 31, 2023 |
Dec 31, 2022 |
Dec 31, 2023 |
Dec 31, 2022 |
|
| Opening cost | 173,878 | 173,878 | 173,878 | 173,878 |
| Sales and disposals | -173,878 | 0 | -173,878 | 0 |
| Total | 0 | 173,878 | 0 | 173,878 |
| Opening amortization | -19,662 | -7,244 | -19,662 | -7,244 |
| Amortization for the year | -6 209 | -12,418 | -6 209 | -12,418 |
| Disposals | 25 871 | 0 | 25 871 | 0 |
| Closing accumulated amortiza tion and imperiment |
0 | -19,662 | 0 | -19,662 |
| Opening amortization | 0 | 0 | 0 | 0 |
| Amortization for the year | -103,864 | 0 | -103,864 | 0 |
| Disposals | 103,864 | 0 | 103,864 | 0 |
| Closing accumulated amorti zation |
0 | 0 | 0 | 0 |
| National and European subsidies of development expenditure |
||||
| Opening balance | -44,142 | -44,142 | -44,142 | -44,142 |
| Deducted in the year | 44,142 | 0 | 44,142 | 0 |
| Total | 0 | -44,142 | 0 | -44,142 |
| Carrying amount | 0 | 110,073 | 0 | 110,073 |
NOTE 3 CAPITALIZED DEVELOPMENT EXPENDITURE
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 | |||
|---|---|---|---|---|
| Dec 31, 2023 |
Dec 31, 2022 |
Dec 31, 2023 |
Dec 31, 2022 |
|
| Opening cost | 24,121 | 23,815 | 24,121 | 23,815 |
| Investment | 35 | 368 | 35 | 368 |
| Disposals | -22,223 | -62 | -22,223 | -62 |
| Closing accumulated cost | 1,933 | 24,121 | 1,933 | 24,121 |
| Opening amortization | -2707 | -1,549 | -2707 | -1,549 |
| Amortization for the year | -742 | -1,158 | -742 | -1,158 |
| Disposals | 2,179 | 0 | 2,179 | 0 |
| Closing accumulated amortization |
-1,269 | -2,707 | -1,269 | -2,707 |
| Opening impairment | -598 | -598 | -598 | -598 |
| Impairment for the year | -19,446 | 0 | -19,446 | 0 |
| Disposals | 20,044 | -598 | 20,044 | -598 |
| Closing accumulated impairment | 0 | 0 | 0 | 0 |
| Carrying amount | 664 | 20,816 | 664 | 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 patents.
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 | |||
|---|---|---|---|---|
| Dec 31, 2023 |
Dec 31, 2022 |
Dec 31, 2023 |
Dec 31, 2022 |
|
| Opening cost | 3,911 | 3,675 | 2,146 | 2,146 |
| Investment | 1,026 | 0 | 1,026 | 0 |
| Sales and scrapping | -1,718 | 0 | -1,718 | 0 |
| Translation differences for the year | -67 | 235 | 0 | 0 |
| Closing accumulated cost | 3,152 | 3,911, | 1,454 | 2,146 |
| Opening amortization | -1,203 | -689 | -701 | -529 |
| Amortization for the year | -364 | -480 | -51 | -172 |
| Sales and disposals | 273 | 0 | 273 | 0 |
| Translation differences for the year | 25 | -33 | 0 | 0 |
| Closing accumulated amortization | -1,269 | -1,203 | -479 | -701 |
| Opening impairment | 0 | 0 | 0 | 0 |
| Impairment for the year | -1,359 | 0 | -1,359 | 0 |
| Disposals | 1,359 | 0 | 1,359 | 0 |
| Closing accumulated impairment | 0 | 0 | 0 | 0 |
| Carrying amount | 1,883 | 2,708 | 975 | 1,445 |
| Closing amount of intangible assaets note 3-5 |
2,547 | 133,597 | 1,639 | 132,335 |
For licenses, the basis for depreciation is 3.2 (3.9) MSEK. Carrying value for licenses amounts to 2.1 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
The group has leasing agreements, mainly agreements for the use of office premises, where one of the agreements extends to 31 October 2028 with a quarterly fee of kSEK 1,557. With the decision to cease commercialization of the IMMray™ PanCan-d test and to discontinue operations, there is a need to renegotiate this lease agreement. Based on a signed letter of intent with one lessor, with the mutual intention and probable outcome that the long-term lease will terminate in Q1 2024, the Company has revalued the lease agreement. This has had an impact on the balance sheet for the group, where the right-ofuse asset and the lease liability will decrease by approximately 20 MSEK. The remaining right-of-use asset and the lease liability as of December 31, 2023, have been reported based on a calculated and assessed probable lease obligation for 2024 of a combined approximate sum of 8 MSEK.
NOTE 7 OTHER LIABILITIES
Other liabilities have been affected by termination and severance pay.
IMMUNOVIA AB EARLY DETECTION
OTHER INFORMATION
Review
This interim report has not been reviewed by the company's auditors.
Financial calendar
Q1 interim report 2024, Thursday April 25, 2024 Q2 interim report 2024, Thursday August 22, 2024 Q3 interim report 2024, Thursday November 14, 2024
Annual General Meeting
The AGM will be held on Thursday April 25, 2024. Annual Report 2023 will be available from last week of March.
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 February 21, 2024.
Conference call
Immunovia will hold a webcast teleconference at 15:00 CET on February 21, 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.
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: creo-live.creomediamanager.com/cff0b72c-e4f5-48b2-8bc0-47467df18f1b
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 February 21, 2024
Peter Høngaard Andersen Chairman of the board
Hans Johansson Board member
Michael Löfman Board member
Martin Møller Board member
Melissa Farina Board member Valerie Bogdan-Powers 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.
IMMUNOVIA AB EARLY DETECTION Phone: +46 (0)46-275 60 00 [email protected] www.immunovia.com
Scheelevägen 8, Medicon Village 223 63 Lund, Sweden