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Immunovia

Quarterly Report Apr 29, 2024

3061_10-q_2024-04-29_43788dd9-7f1e-4711-8d56-d67db3e390d6.pdf

Quarterly Report

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interim report JANUARY-MARCH 2024

January-March 2024

  • Net sales, which for the quarter only included royalties, amounted to SEK 156 (520)
  • Net earnings amounted to KSEK -2,946 (-51,658), where exchange rate effects of KSEK 21 358 (435) had a substantial impact.
  • Earnings per share before and after dilution were SEK -0.07 (-2.28).
  • Cash Flow from operating activities amount MSEK -24.4 (39.7).
  • Cash and equivalents at the end of the period amounted to MSEK 51.2 (68.2).
  • On January 31, the Company announced that Norma Alonzo Palma had been appointed Vice President of Clinical and Medical Affairs

Significant events after the period

  • On April 9, the Company announced that Immunovia had successfully developed accurate and precise assays to measure targeted proteins for its next-generation test.
  • On April 22, the Company announced positive results from the model-development study for its next-generation pancreatic cancer detection test.

"I am proud to report that we delivered on our promises in transforming Immunovia to a new and more agile company with a significantly lower cost base, faster pace, greater efficiency, and better results. Our new test demonstrated positive results in the model-development study, validating our decision from last summer to shift resources from IMMrayPanCan-d to the new product. We are committed to bringing value to shareholders by launching the new test in 2025 to meet the substantial market demand for a simple and affordable blood test for early detection of pancreatic cancer."

Jeff Borcherding, CEO and President, Immunovia AB

2024 2023 2023
SEK thousand unless otherwise stated Jan-March Jan-March Full year
Net sales 156 520 1,575
Operating earnings/loss -24,157 -49,082 -296,460
Earnings before tax -2,946 -51,658 -309,438
Net earnings -2,946 -51,658 -309,438
Earnings per share before dilution (SEK) -0,07 -2.28 -7,95
Earnings per share after dilution (SEK) -0,07 -2.28 -7,95
Equity ratio (%) 62 77 68
Number of shares at the end of the period 45,287,498 22,631,581 45,287,498

Key indicators

CEO's comments

I am proud to report that we delivered on our promises in transforming Immunovia to a new and more agile company with a significantly lower cost base, faster pace, greater efficiency, and better results. Our new test demonstrated positive results in the model-development study, validating our decision from last summer to shift resources from IMMrayPanCan-d to the new product. We are committed to bringing value to shareholders by launching the new test in 2025 to meet the substantial market demand for a simple and affordable blood test for early detection of pancreatic cancer.

Our next-generation test met the predefined performance criteria and outperforms IMMrayPan-Can-d

We were thrilled to announce on April 22 that our next-generation test performed very well in the model-development study, achieving both primary and secondary endpoints. The test demonstrated specificity of 98 percent and sensitivity of 75 percent in detecting early-stage (stage 1 and 2) pancreatic ductal adenocarcinoma (PDAC), which is the most common form of pancreatic cancer. The next-generation test's strong performance in differentiating PDACs from controls was especially impressive since the control samples represented a wide range of subjects, including people at high-risk for hereditary and familial pancreatic cancer, diabetics, patients with benign pancreatic lesions worrisome for PDAC, and healthy individuals.

Our next-generation test was also significantly more accurate in the study than CA19-9, the biomarker commonly used to detect pancreatic cancer. Outperforming CA19-9 is crucial to securing reimbursement for the new test.

The next-generation test is clearly superior to our first-generation test, IMMray™ PanCan-d. First, the new test accurately distinguished pancreatic cancer from a wider range of control samples. Second, the next-generation test does not have a "borderline" category as the IMMray™ PanCan-d test did. All patients tested with our new test will receive a "positive" or "negative" result. This will provide patients and clinicians with much greater clarity and appropriately guide next steps, eliminating the indecision of a "borderline" result. Finally, the protein biomarkers in the new test are more accurate, reducing reliance on CA19-9. The IMMray™ PanCan-d excluded about 10% of patients because they had a genetic mutation that prevents them from producing CA19-9. This genetic mutation is particularly prevalent in people of African ancestry and Hispanic ethnicity. With our next-generation test we expect to provide a test for the full population of individuals at risk, further expanding the commercial opportunity.

These results confirm we made the right decision in shifting our focus from IMMray™ PanCan-d to the new test. We now have a test that includes more accurate biomarkers, outperforms CA19-9, expands the market relative to the IMMray test, and offers a much better chance to secure reimbursement and drive commercial success.

We are moving much faster and are completing promised milestones on time

In July 2023 we announced a transformation of Immunovia to significantly increase efficiency and speed. The benefits of this transformation have since become clear. We have moved very rapidly through the test development process. We have set aggressive timelines and are hitting our marks. Since July, we have completed the largest-ever study to identify pancreatic cancer protein biomarkers. We developed assays to accurately measure these protein biomarkers and have conducted the model-development study. All these milestones were completed on the promised timing. Our successful collaboration with Proteomedix, an Onconetix company, has provided expertise and capacity, while accelerating our pace. We now have the people, plans, and processes to deliver at a dramatically faster pace than what Immunovia achieved previously.

In the first quarter, we largely completed the transition from the proprietary IMMray platform to ELISA. The benefits are clear. Lab results prove the ELISA assays are more accurate and more reproducible than IMMray assays. The new ELISA assays will also reduce turnaround time for the commercial test to 1 or 2 days. Finally, the new platform has much lower fixed costs and will reduce our cost per test.

Our cash burn is in line with expectations and we have a plan to raise capital

First quarter 2024 cash burn averaged 8.7 MSEK per month, in line with our forecast. We have dramatically reduced our staffing costs and operating expenses, as cuts made in 2023 began to deliver the expected savings. 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™ Pan-Can-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.

Our team is performing at a very high level

Over the past year we reduced staffing by nearly 80% and had only 11 full-time employees as of the end of the first quarter. The team includes top performers from Immunovia as well as two critical new hires. Our employees are supported by a tremendous set of consultants, contractors, and external partners such as Proteomedix. This collective team has performed tremendously well over the last year. I am incredibly grateful for their agility and focus, their extraordinary level of effort, and their passion for our mission.

Our next steps are clear, and we have well-defined plans to bring the next-generation test to market

We will now move to a second phase of the model development study, expected to be completed in June. In the second and third quarters, we will perform several analytical validation steps to verify the accuracy and reproducibility of the protein assays. In the fourth quarter, we will initiate a large clinical validation study to confirm the performance of the next-generation test, which we expect to complete in Q1 2025. We also will partner with leading pancreatic cancer researchers on additional clinical studies starting in early 2025 to support a commercial launch in 2025 as well as future reimbursement.

The market need for an early detection test remains very strong and we are rapidly making progress to meet this need

Market demand for a blood test to detect pancreatic cancer remains very strong. Leading experts in the field confirm the incredible patient desire for a blood test to simplify surveillance. Clinicians who monitor high-risk individuals understand the burdens of annual imaging and are eager to have a blood test to make surveillance faster and more convenient for patients. Meeting this need will enable us to drive volume, revenue, and shareholder value.

3

April 29, 2024 Jeff Borcherding President & CEO, Immunovia AB

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
Accounting principles 18
Glossary 22
Immunovia in brief 24

About the report

This information was submitted for publication on April 29, 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 • [email protected] 4

The Group's performance over the period

Net sales

Net sales, which for the first quarter of 2024 only include royalties, amounted to SEK 156,000. Corresponding period in the previous year, net sales were SEK 520,000 divided between sales of tests SEK 379,000 and royalties SEK 141,000.

Earnings

The net result for the first quarter of 2024 amounted to -2.9 MSEK (-51.7). The main difference in net profit is due to the fact that the financial net is positive 21.4 MSEK.

Other external costs and personnel costs decreased during the first quarter by 20.6 MSEK compared to the corresponding period last year. The reduction is mainly due to a reduced organization and reduced scope of the operational activities.

Research & Development

Costs for research and development for the first quarter amounted to 9.2 MSEK (9.2), which corresponds to 18 percent (18) of the group's total operating costs.

Financing and cash flow

Cash flow from operating activities during the first quarter of the year amounted to -24.4 MSEK (-39.7). The reduced negative cash flow for the first quarter of 2024 is mainly due to the reduction of the organization.

Cash and cash equivalents as of March 31, 2024 amounted to 51.2 MSEK (68.2).

Equity at the end of the period amounted to 43.7 MSEK (194.3) and the equity ratio was 62 percent (77).

Going concern

With a cash balance of 51 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

Equity at the end of the period amounted to 43.7 MSEK (194.3) and the equity ratio was 62 percent (77).

In the first quarter of 2024, no intangible assets were acquired, nor did they correspond to the period in 2023.

No investments in tangible fixed assets in the form of inventories were made during the first quarter of 2023 and 2024.

No financial transactions made during the first quarter of 2024.

Employees

Average number of employees during the first quarter of 2024 amounted to 11 (51) and at the end of the period the number of employees was 10 people (51).

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
Shareholders No. of shares Share (capital and votes)
Avanza Pension 4,473,228 9.88%
Carl Borrebaeck 1,709,900 3.78%
Vincent Saldell 980,000 2.16%
Mats Ohlin 848,950 1.87%
Sara Andersson Ek 848,907 1.87%
Christer Wingren 748,525 1.65%
Hans Johansson 327,356 0.72%
Nordnet Pensionsförsäkring AB 464,809 1.03%
Sten Johnsson 416,001 0.92%
Jeff Borcherding 350,000 0.77%
Ten largest owners 11,167,676 24.66%
Others 34,119,822 75.34%
Total 45.287,498 100.00%

The 10 largest shareholders on March 31, 2024

Source: Monitor by Modular Finance AB. Compiled and processed data from Euroclear, Morningstar and the Swedish Financial Supervisory Authority, among others

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

Number of
outstanding
Sub
scription
price/
Change in share
capital at full
Total cost of
alternative
cash-based
incentive pro
Incentive program Decision date Utilization period warrants share utilization 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 Nov 21, 2023 Until December 28, 2033 649,309 32,465.45
Total 1,055,309 52,765.45 39,812

Consolidated income statement, summary

2024 2023 2023
Jan-March Jan-March Full,year
156 520 1,575
448 78 227
604 598 1,802
0 -1,039 -6,682
-14,348 -20,555 -68,723
-7,398 -21,756 -79,580
-2,980 -6,072 -141,719
-35 -258 -1,558
-24,761 -49,680 -298,262
-24,157 -49,082 -296,460
21,358 435 6,278
-147 -3,011 -19,257
21,211 -2,576 -12,978
-2,946 -51,658 -309,438
0 0 0
-2,946 -51,658 -309,438
-0,07 -2.28 -7.95
-0,07 -2.28 -7.95
45,287,498 22,631,581 38,931,255
45,287,498 22,631,581 45,287,498

Consolidated comprehensive income, summary

2024 2023 2023
SEK thousands Jan-March Jan-March Full year
Earnings/loss for the period -2,946 -51,658 -309,438
Items that may be reclassified later in the income
statement
Exchange rate differences for foreign net
investment -20,350 -2,128 11,383
Other earnings/loss for the period -20,350 -2,128 11,383
Comprehensive income for the period -23,296 -53,786 -298,055

Consolidated financial position, summary

2024 2023 2023
SEK thousands March 31 March 31 Dec 31
ASSETS
Fixed assets
Intangible fixed assets 2,433 130,071 2,547
Tangible fixed assets 12,502 45,210 15,117
Financial fixed assets 536 3 506
Total fixed assets 15,471 175,284 18,170
Current assets
Inventory 0 2,341 0
Accounts receivable 0 162 146
Other short term receivables 4,375 6,979 3,577
Cash and cash equivalents 51,178 68,237 76,788
Total current assets 55,553 77,719 80,511
TOTAL ASSETS 71,024 253,003 98,681
EQUITY AND LIABILITIES
Equity
Share capital 2,264 1,132 2,264
Other contributed capital 1,136,480 1,016,369 1,136,480
Translation reserve -33,273 -22,178 -12,923
Retained earnings incl. total comprehensive income -1,061,776 -801,050 -1,058,830
Total equity 43,695 194,273 66,991
Long-term liabilities
Interest-bearing liabilities 0 29,589 1,787
Total long-term liabilities 0 29,589 1,787
Current liabilities
Interest-bearing liabilities
8,793 6,347 8,478
Other liabilities 18,536 22,794 21,425
Total current liabilities 27,329 29,141 29,903
TOTAL EQUITY AND LIABILITIES 71,024 253,003 98,681

Change in consolidated equity, summary

Share Other
contributed
Accumulated
earnings/loss for
SEK thousands capital equity Reserves the period Total equity
Opening balance January 1, 2023 1,132 1,016,369 -24,306 -749,392 243,803
Comprehensive income for the period 2,128 -51,658 -49,530
Transactions with owners in their
capacity as owners
Closing balance March 31, 2023 1,132 1,016,369 -22,178 -801,050 194,273
Comprehensive income for the period 9,255 -257,780 -248,525
Transactions with owners in their
capacity ac owners
New share issue 1,132 150,662 151,794
Issue costs -30,551 -30,551
Closing balance December 31, 2023 2,264 1,136,480 -12,923 -1,058,830 66,991
Comprehensive income for the period -20,350 -2,946 -23,296
Transactions with owners in their
capacity as owners
Closing balance March 31, 2024 2,264 1,136,480 -33,273 -1,061,776 43,695

Consolidated cash flow statement, summary

2024 2023 2023
SEK thousands Jan-March Jan-March Full year
Operating activities
Operating earnings/loss -24,157 -49,082 -296,459
Adjustment for items not included in cash flow 2,977 5,634 140,522
Interest received 536 435 2,912
Interest paid -147 -365 -1,166
Tax paid 0 0 0
Cash flow from operating activities before changes
in working capital
-20,791 -43,378 -154,191
Cash flow from changes in working capital
Change in inventory 0 0 1,995
Change in operating receivables -603 0 4,730
Change in operating liabilities -3,027 3 493 409
Cash flow from operating activities -24,421 3 493 -147,057
Investment activities
Investment in intangible assets 0 0 -1,061
Investment in tangible assets 0 0 0
Sale of fixed assets 0 0 1,329
Other long term receivables 0 3,493 2,929
Cash flow from investment activities 0 3,493 3,197
Financing activities
Amortization of leasing liability -1,536 -1,567 -6,500
New share issue 0 0 121,243
Received warrants premiums 0 0 0
Cash flow from financing activities -1,536 -1,567 114,743
Cash flow for the period -25,957 -37,775 -29,117
Cash and cash equivalents at start of period 76,788 106,041 106,041
Exchange rate difference in cash and cash
equivalents 347 -29 -136
Cash and cash equivalents at end of period 51,178 68,237 76,788

Consolidated key indicators

2024
Jan-March
2023
Jan-March
2023
Full year
2022
Full year
2021
Full year
Operating earnings/loss (SEK 000) -24,157 -49,082 -296,460 -191,150 -166,628
Earnings/loss for the year (SEK 000) -2 946 -51,658 -309,438 -168,092 -155,966
Earnings per share before dilution (SEK) -0,07 -2.28 -7.95 -7.43 -6.89
Earnings per share after dilution (SEK) -0,07 -2.28 -7.95 -7.43 -6.89
R&D expenses (SEK 000) -6,554 -9,188 -28,207 -47,902 -42,850
R&D expenses as percentage of operating
expenses (%)
27 18 9 25 24
Cash and cash equivalents at the period's end
(SEK 000)
51,178 68,237 76,788 106,041 287,406
Cash flow from operating activities (SEK 000) -24,421 -39,701 -147,057 -175,582 -152,648
Cash flow for the period (SEK 000) -25,957 -37,775 -28,489 -182,313 -181,743
Equity (SEK 000) 43,695 194,273 66,991 243,803 433,903
Equity per share (SEK) 0.10 8.58 1.48 10.77 19.17
Equity / assets ratio (%) 62 77 68 81 88
Average number of employees 11 51 32 64 67
Average number of employees in R&D 2 17 7 18 23

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

2024 2023 Full year
SEK thousands Jan-March Jan-March 2023
Operating income etc.
Net sales 156 4,991 12,977
Other operating income 361 78 228
Total operating income 517 5,069 13,205
Operating expenses
Raw material and consumables 0 -835 -3,948
Other external expenses -12,547 -14,340 -51,321
Personnel costs -3,890 -10,332 -37,309
Amortization of intangible and
tangible fixed assets -369 -4,160 -134,186
Other operating expenses -35 -246 -389
Total operating expenses -16,841 -29,913 -227,152
Operating earnings/loss -16,324 -24,844 -213,948
Operating expenses
Result from shares in group companies -34,813 -23,636 -75,858
Financial incomes 23,908 2,297 12,130
Financial expenses -1 0 -15,074
Total financial items -10,906 -21,339 -78,802
Earnings/loss after financial items -27,230 -46,183 -292,750
Allocations
Group contributions received 0 0 0
Total allocations 0 0 0
Earnings/loss before tax -27,230 -46,183 -292,750
Income tax 0 0 0
Earnings/loss for the period -27,230 -46,183 -292,750

Parent company's comprehensive income, summary

2024 2023 2023
SEK thousands Jan-March Jan-March Full year
Earnings/loss for the period -27,230 -46,183 -292,750
Other earnings/loss for the period 0 0 0
Comprehensive income for the period -27,230 -46,183 -292,750

Parent company's balance sheet, summary

2024 2023 2023
SEK,thousands March,31 March,31 Dec,31
ASSETS
Fixed,assets
Intangible,fixed,assets 1,549 128,898 1,639
Tangible,fixed,assets 3,484 6,770 3,764
Financial,fixed,assets 303 328 303
Total,fixed,assets 5,336 135,996 5,706
Current,assets
Inventory 0 1,900 0
Account,receivables 0 0 146
Receivables,from,Group,companies 138 685 660
Current,receivables 1,233 2,507 782
Prepaid,expenses,and,accrued,income 1,969 3,254 2,203
Cash,and,cash,equivalents 44,249 63,994 71,090
Total,current,assets 47,589 72,340 74,881
TOTAL,ASSETS 52,925 208,336 80,587
EQUITY,AND,LIABILITIES
Equity
Restricted,equity 2,264 1,132 2,264
Fund,for,development,expenses 0 102,359 0
Total,equity,and,liabilities 2,264 103,491 2,264
Non-restricted,equity
Premium,fund 120,111 0 0
Retained,earnings,including,comprehensive,income -86,672 84,765 60,669
Total,non-restricted,equity 33,439 84,765 60,669
Total,equity 35,703 188,256 62,933
Current,liabilities
Other,liabilities 17,222 20,080 17,654
Total,current,liabilities 17,222 20,080 17,654
TOTAL,EQUITY,AND,LIABILITIES 52,925 208,336 80,587

Parent company's cash flow statement, summary

2024 2023 2023
SEK thousands Jan-March Jan-March Full year
Operating activities
Operating earnings/loss -16 324 -24,844 -213,948
Adjustment for items not included in cash flow 369 4,160 134,181
Interest received 536 435 2,880
Interest paid -1 0 -5
Tax paid 0 0 0
Cash flow from operating activities before changes in working
capital
-15,420 -20,249 -76,892
Cash flow from changes in working capital
Change in inventory 0 -353 1,546
Change in operating receivables -10,990 -21,530 -78,801
Change in operating liabilities -431 2,173 -227
Cash flow from operating activities -26,841 -39,959 -154,374
Investment activities
Investment in intangible fixed assets 0 0 -1,061
Investment in tangible fixed assets 0 0 0
Investment in financial fixed assets 0 0 0
Sale of fixed assets 0 0 1,329
Cash flow from investment activities 0 0 268
Financing activities
New share issue 0 0 121,243
Cash flow from financing activities 0 0 121,243
Cash flow for the period -26,841 -39,959 -32,863
Cash and cash equivalents at start of period 71,090 103,953 103,953
Cash and cash equivalents at period's end 44,249 63,994 71,090

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.

Revenue recognition

Net sales for the first quarter 2024 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 2023, page 33.

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 52,883 (77,296) March 31, 2024.

Liquidity risk and going concern

With a cash balance of 51 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 34 MSEK in Immunovia AB, to continuously write down the receivables arising from the parent company's financing to the subsidiary Immunovia Inc.

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OTHER INFORMATION

Review

This interim report has not been reviewed by the company's auditors.

Financial calendar

Q2 interim report 2024, Thursday August 22, 2024 Q3 interim report 2024, Tuesday November 14, 2024 Financial statement 2024, Tuesday February 25, 2025

Annual General Meeting

The AGM will be held on Thursday June 4, 2024. Annual Report 2023 will be available from first week of May.

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 April 29, 2024.

Conference call

Immunovia will hold a webcast teleconference at 15:00 CET on April 29, 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/b493ca7a-4f83-40f5-85aa-b9e5e7503b63

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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 April 29, 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.

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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 är ett diagnostikföretag vars mission är att öka överlevnaden för patienter med bukspottkörtelcancer genom tidig upptäckt av cancer. Immunovia fokuserar på utveckling och kommersialisering av enkla blodbaserade tester för att upptäcka proteiner och antikroppar som indikerar att en individ med hög risk har utvecklat bukspottkörtelcancer.

Immunovia samarbetar och engagerar sig med vårdgivare, ledande experter och patientgrupper för att göra sitt test tillgängligt för individer med ökad risk för bukspottkörtelcancer.

USA är världens största marknad för upptäckt av cancer i bukspottkörteln. Företaget uppskattar att 1,8 miljoner individer i USA löper hög risk för cancer i bukspottkörteln som årligen skulle dra nytta av ett test.

Immunovias aktier (IMMNOV) är noterade på Nasdaq Stockholm. För mer information, besök www.immunovia.com

IMMray™ PanCan-d enables diagnosis of patients with pancreatic cancer before symptoms are noted (stages I and II).

It is estimated that early detection of pancreatic cancer would increase the five-yearsurvival rate up to 50 percent.

Phone: +46 (0)46-275 60 00 [email protected] www.immunovia.com

Scheelevägen 8, Medicon Village 223 63 Lund, Sweden

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