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Immunovia

Quarterly Report Nov 27, 2024

3061_10-q_2024-11-27_f46420c6-7bc2-4f9a-8eae-c703d836bce6.pdf

Quarterly Report

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INTERIM REPORT JANUARY-SEPTEMBER 2024

July-September 2024

  • Net sales, which for the quarter only included royalties, amounted to 235 KSEK (488).
  • Net earnings amounted to -51.1 MSEK (-38.6).
  • Earnings per share before and after dilution were -0.73 SEK (-0.91).
  • Cash flow from operating activities amounted to -21.2 MSEK (-35.6).
  • Cash and cash equivalents at end of period amounted to 54.2 MSEK (106.7)
  • New lab staffed and fully operational after rapid implementation and validation was announced on July 2.
  • Detailed discovery study results for the company's next-generation early detection test for pancreatic cancer were presented at the PancreasFest 2024 Annual Meeting on July 25.
  • Completion of the development of the pancreatic cancer detection test after substantially increasing test accuracy was announced on August 1.
  • Filing of a US provisional patent application to protect its next-generation test was announced on August 2.
  • Immunovia's next generation test to be included in a large study of pancreatic cysts funded by the US National Institutes of Health, was announced August 5.
  • On August 6 Immunovia announced final terms of rights issue and on August 12 the prospectus in connection with forthcoming rights issue was published.
  • On September 2 the preliminary outcome off the rights issue was published and on September 3 the final outcome in rights issue was announced.
  • On September 12 Immunovia carried out a directed issue of units to guarantors in connection with the completed rights issue.
  • Data from the model development study was presented at the 2024 AACR Advances in Pancreatic Cancer medical conference, which was announced on September 16.
  • On September 30 the company informed on the change in number of shares and votes in Immunovia AB.

Significant events after the period

  • October 2 the company informed that the company has completed the analytical validation of its next-generation test designed to detect early-stage pancreatic cancer, which demonstrated excellent results, reinforcing the reliability and robustness of the test.
  • The successful acquisition of all blood samples required to clinically validate its next-generation test for pancreatic cancer was announced on October 6.
  • On the November 7 Immunovia presented an update from the model development study on its next-generation test at the annual meeting of the PRECEDE Consortium, a collaboration of 51 pancreatic centers worldwide.
  • On November 15, the Company presented the model-development study results at a meeting of the Collaborative Group of the Americas—Inherited Gastrointestinal Cancers.

" Q3 marked another quarter of strong performance as we continued to achieve our goals and deliver on milestones. As previously reported, the analytical validation proved our next-generation test to be accurate, stable and precise. The test development will culminate with the clinical validation, which will read out in Q4. Looking ahead to 2025, we will transition from focusing on research and development to commercializing the new test and generating further clinical evidence."

Jeff Borcherding, CEO and President, Immunovia AB

Key indicators

SEK thousand unless otherwise stated 2024
Jul-Sep
2023
Jul-Sep
2024
Jan-Sep
2023
Jan-Sep
2023
Full year
Net sales 235 488 476 1,419 1,575
Operating earnings/loss -31.228 -38.889 -79.292 -273,054 -296,460
Earnings before tax -51.068 -38.556 -79.611 -260,419 -309,438
Net earnings -51.068 -38.556 -79.611 -260,419 -309,438
Earnings per share before dilution (SEK) -0.73 -0.91 -1.49 -7.99 -7,95
Earnings per share after dilution (SEK) -0.73 -0.91 -1.49 -7.99 -7,95
Equity ratio (%) 61 62 61 62 68
Number of shares at the end of the period 169,711,476 45,287,498 169,711,476 45,287,498 45,287,498

CEO's comments

ON PLAN FOR A US MARKET INTRODUCTION IN 2025

Q3 marked another quarter of strong performance as we continued to achieve our goals and deliver on milestones. As previously reported, the analytical validation proved our next-generation test to be accurate, stable and precise. The test development will culminate with the clinical validation, which will read out in Q4. Looking ahead to 2025, we will transition from focusing on research and development to commercializing the new test and generating further clinical evidence.

WE ACHIEVED OUR Q3 GOALS AND ARE MAKING EXCELLENT PROGRESS IN Q4

We closed a successful rights issue in which Investors subscribed to over 90% of the units offered, significantly exceeding expectations. This high level of participation enhances our chances for a very successful outcome for our TO2 and TO3 warrants in January and April 2025, respectively. Assuming the same level of participation in the warrants offering as in the rights issue in total would give us more than 12 months of runway and enable us to pursue our 2025 goals, outlined below.

We took important steps to validate the performance of our new test in Q3. Through the analytical validation, we have confirmed the technical performance of our next-generation test in measuring the target proteins. We also obtained blood samples from over 200 pancreatic cancer patients and more than 800 high-risk individuals for the next step: the clinical validation of the test. Securing over a thousand samples on such short timing was possible thanks to our strong relationships with experts at leading pancreatic cancer programs. We were also the first diagnostics company to receive blood samples from the PRECEDE Consortium.

Clinical validation is our key focus in Q4. The study is well underway, with our lab team in Research Triangle Park, North Carolina, analyzing hundreds of samples. We expect to complete the study and announce results in December 2024.

OUR PLAN FOR 2025 IS CLEAR AND FOCUSED

Looking forward to 2025, we will focus on the following goals:

    1. Execute on a targeted introduction of the next-generation test in the US.
    1. Complete additional clinical studies needed to secure reimbursement.
    1. Secure a strategic partner at the appropriate time to expand commercial reach and accelerate market penetration.
    1. Ensure sufficient resources for the targeted launch and additional clinical studies.

We will execute a targeted launch of the next-generation test in the second half of 2025. We expect to conduct a targeted launch of the next-generation test in the United States in the second half of 2025. The test will be launched as a lab-developed test (LDT) and all samples will be processed at our lab in Research Triangle Park, USA.

Our objective for the initial launch phase is to demonstrate physician and patient demand. The key measure of success will be test adoption and volume at targeted pancreatic centers. This will support our efforts to secure a strategic partner. It will also bolster our reimbursement efforts as payers want to see evidence that clinicians are using the test.

We expect reimbursement of the test to come in 2026 after payer review of published clinical study results. At launch, we will likely pursue a patient-pay model in which patients will be asked to pay a portion of the normal cost of the test.

2

Since revenue per test will be very limited in 2025, we will pursue a targeted, limited scale, cost-effective launch. Immunovia will employ a small sales team focused on the top high-risk surveillance programs for pancreatic cancer. Their goal will be to drive trial and adoption of the test at these expert centers, creating advocacy among the key opinion leaders in pancreatic cancer. We expect the broader selling effort to be executed later by a strategic partner, deploying a much larger sales team to expand reach and drive volume among pancreatologists, interventional endoscopists, gastroenterologists and genetic counselors.

We will conduct additional clinical studies required by US payers. We will conduct two additional clinical validity studies in the high-risk hereditary patient population in the first half of 2025. We will then investigate additional high-risk groups, including individuals with new-onset diabetes, chronic pancreatitis, and pancreatic cysts. Fortunately, we expect to conduct this clinical program quickly and at a reasonable cost by utilizing Immunovia biobank samples, plus samples from pancreatic cancer centers where we have strong relationships. Further, as announced in August 2024, Immunovia's next-generation test will be studied as part of a National Institutes of Health (US) clinical program in pancreatic cyst patients.

We will pursue a strategic partner to drive commercialization of the test. Lessons from the IMMray PanCan-d launch made it clear we need a strategic partner to help commercialize our next-generation test. Partnering with a diagnostics company with a large sales force will enable us to drive more test volume, sooner and at a lower cost. Over the last 18 months, we have established relationships with more than a dozen promising prospective partners, holding regular update meetings. After successful completion of the clinical validation study we will share study results with them.

We will be intentional about the timing of any partnership. We will develop the product and clinical portfolio far enough to secure attractive terms. We will diligently pursue a strategic partner in the coming quarters and strike an agreement when timing is optimal.

We are well positioned to fund activities for the next twelve months and will strategically manage capital needs. In 2025 we will shift spending from research and product development to clinical studies and a targeted introduction of the test in the US. We will strategically evaluate the optimal timing and vehicles to fund these operating expenses beyond the next twelve months.

The Immunovia team is committed to rewarding our shareholders. I want to emphasize how committed we are as a team to seeing Immunovia succeed. This is a passionate, dedicated, resilient group of people and I'm incredibly proud to see their hard work paying off. I believe deeply in what we are doing. As evidence of my belief and engagement, I purchased 1,470,588 units in the rights issue, 140 percent of my pro rata share of the issue.

I welcome your input and feedback on how we achieve our goals and deliver value for shareholders. Contact me at [email protected] with questions or suggestions. Also, please follow and connect with us on LinkedIn https://www.linkedin.com/company/immunovia-ab/ . This platform provides an excellent opportunity for me to share information with you beyond our quarterly reports and press releases.

November 27, 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
Notes 18
Glossary 22
Immunovia in brief 24

About the report

This information was submitted for publication on November 27, 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]

january-september 2024 The Group's performance over the period

Net sales

The net sales, which for the third quarter of 2024 only include royalties, amounted to KSEK 235. For the corresponding period in the previous year, net sales were KSEK 488 divided between test sales KSEK 70 and royalties KSEK 418. For the period January to September 2024, sales amounted to KSEK 476 (1,419) divided between sales of tests KSEK 0 (799) and royalties KSEK 476 (620).

Earnings

The net profit for the third quarter of 2024 amounted to -51.1 MSEK (-38.6). The result during the quarter has been charged with unrealized exchange rate effects of MSEK 18.3 as well as a one-time provision for onerous contracts of MSEK 7.3 (see further Note 2), which is the reason for the larger losses during quarter 3, 2024 compared to the same period last year. Due to the reduced organization, personnel costs decreased from MSEK 17.1 in the third quarter of 2023 to MSEK 6.5 in the third quarter of 2024.

For the period January to September 2024, the net earnings amounted to -79.6 MSEK (-260.4). Costs of a one-off nature in 2023 have impacted the comparability between the years.

Research & Development

Total costs for research and development for the third quarter of 2024 amounted to MSEK 9.1 (6.7), which corresponds to 29 percent (13) of the group's total operating costs.

Financing and cash flow

Cash flow from operating activities during the third quarter of the year amounted to MSEK -21.2 (-35.6) excluding provision for onerous contracts and for the period January-September 2024, the cash flow from operating operations amounted to MSEK -73.8 (-106.7).

During the third quarter of 2024, a rights issue of units was carried out, which net of issuance costs added MSEK 52.4 to equity. Equity amounted to MSEK 38.6 million (93.2) at the end of the period.

Cash and cash equivalents as of September 30, 2024 amounted to MSEK 54.2 (106.7).

The annual general meeting on June 19, 2024 resolved on a rights issue of units, which was executed in September 2024 and subscribed to 91 percent. The issue resulted in additional cash to the Company before issue cost of MSEK 63.2. In January 2025 and April 2025 respectively, the company could obtain additional cash if the warrants of series TO2 and TO3 issued in the rights issue are used to subscribe for shares.

Going concern

With a cash balance of SEK 54 million end of the third quarter, together with estimated net proceeds from the warrants of series TO 2 and TO 3, Immunovia should be able to fund working capital needs for the coming twelve-month period.

Investments

No investments have been made in intangible fixed assets during the period January to September 2024. Last year, MSEK 1.0 was invested in licences.

No investments in tangible fixed assets were made during the period January to September 2024.

No financial investments were made during the period January to September 2024.

Employees

The average number of employees during the third quarter was 9 (29) and at the end of the period the number of employees was 9 (25).

Share information

The number of registered shares amounted to 169,711,476 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
June 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
Sept 12, 2024 Reduction of nominal value 1,358,624.94 -905,749.96 45,287,498 0 0.03
Sept 12, 2024 New share issue 5,078,645.88 3,720,020.94 169,288,196 124,000 698 0,03
Sep 13, 2024 New share issue via units 5,091,344.28 12,698.40 169,711,476 423,280 0.03
At the end of
the period
5,091,344.28 169,711,476 0,03
Shareholders No. of shares Share (capital and votes)
Avanza Pension 19,712,460 11.62%
Vincent Saldell 5,981,000 3.52%
Nordnet Pensionsförsäkring AB 2,989,038 1.76%
Carl Borrebaeck 1,909,900 1.13%
Jens Henrik Lensen 1,692,555 1.00%
Simon Borsos 1,615,000 0.95%
Försäkringsaktiebolaget Skandia 1,583,668 0.93%
Vator Securities AB 1,470,588 0.87%
Sten Jonsson 1,358,834 0.80%
Ghanem Georges Chouba 1,303,968 0.77%
Ten largest owners 39,617,011 23.34%
Others 130,094,465 76.66%
Total 169,711,476 100.00%

The 10 largest shareholders on September 30, 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 three outstanding incentive programs comprising 5,648,596 options with the right to subscribe for 5,648,596 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.

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.

All option programs in the table below have been subject to customary conversion of conditions in connection with issues etc.

Breakdown of outstanding incentive programs

Incentive program Decision date Utilization period Number of
outstanding
warrants
Sub
scription
price/
share
Change in share
capital at full
utilization
Warrant program
2022/2026
April 7, 2022 Jun 1, 2026 – Jun 30, 2026 304,920 36.62 9,147.60
Board ESOP Nov 21, 2023 Until December 28, 2033 1,545,355 0.70 46,360.66
Employee ESOP Nov 21, 2023 Until June 17, 2034 3,798,321 0.70 113,949.62
Total 5,648,596 169,457.88

Consolidated income statement, summary

2024 2023 2024 2023 2023
SEK thousands
NOTE
Jul-Sep Jul-Sep Jan-Sep Jan-Sep Full year
Operating income etc
Net sales 235 488 476 1,419 1,575
Other operating income 73 91 712 173 227
Total operating income 308 579 1,188 1,592 1,802
Operating,expenses
Raw materials and consumables 0 -144 0 -6,682 -6,682
Other external expenses -14,513 -19,636 -43,761 -57,554 -68,723
Personnel costs -6,539 -17,130 -21,498 -70,714 -79,580
Amortization of tangible and intangible
assets -7,556 -2,499 -12,133 -139,282 -141,719
Other operating expenses -2,928 -59 -3,088 -414 -1,558
Total operating expenses -31,536 -39,468 -80,480 -274,646 -298,262
Operating earnings/loss -31,228 -38,889 -79,292 -273,054 -296,460
Profit/loss from financial items
Financial income -18,294 968 1,525 16,928 6,278
Financial expenses -1,546 -635 -1,844 -4,293 -19,257
Total financial items -19,840 333 -319 12,635 -12,978
Earnings/loss after financial items -51,068 -38,556 -79,611 -260,419 -309,438
Income tax 0 0 0 0
Earnings/loss for the period -51,068 -38,556 -79,611 -260,419 -309,438
Earnings per share before dilution (SEK) -0.73 -0.91 -1.49 -7.99 -7.95
Earnings per share after dilution (SEK) -0,73 -0.91 -1.49 -7.99 -7.95
Average number of shares 70,167,590 42,518,441 53,580,862 32,575,011 38,931,255
Number of shares for the period 169,711,476 45,287,498 169,711,476 45,287,498 45,287,498

Consolidated comprehensive income, summary

2024 2023 2024 2023 2023
SEK thousands NOTE Jul-Sep Jul-Sep Jan-Sep Jan-Sep Full year
Earnings/loss for the period -51,068 -38,556 -79,611 -260,419 -309,438
Items that may be reclassified later in the
income statement
Exchange rate differences for foreign net
investment 17,544 507 -1,195 -11,406 11,383
Other earnings/loss for the period 17,544 507 -1,195 -11,406 11,383
Comprehensive income for the period -33,524 -38,049 -80,806 -271,825 -298,055

Consolidated financial position, summary

2024 2023 2023
SEK thousands NOTE Sep 30 Sep 30 Dec 31
ASSETS
Fixed assets
Intangible fixed assets 2,053 2,792 2,547
Tangible fixed assets 2 2,660 34,207 15,117
Financial fixed assets 508 3 506
Total fixed assets 5,221 37,002 18,170
Current assets
Accounts receivable 0 0 146
Other short term receivables 3,674 5,915 3,577
Cash and cash equivalents 54,204 106,677 76,788
Total current assets 57,878 112,592 80,511
TOTAL ASSETS 63,099 149,594 98,681
EQUITY AND LIABILITIES
Equity
Share capital 5,091 2,264 2,264
Other contributed capital 1,186,063 1,136,480 1,136,480
Translation reserve -14,118 -35,712 -12,923
Retained earnings incl. total comprehensive income -1,138,441 -1,009,811 -1,058,830
Total equity 38,595 93,221 66,991
Long-term liabilities
Interest-bearing liabilities
2 0 21,187 1,787
Total long-term liabilities 0 21,187 1,787
Current liabilities
Interest-bearing liabilities
1,496 5,101 8,478
Other Liabilities 15,743 30,085 21,425
Other provisions 2 7,265 0 0
Total current liabilities 24,504 35,186 29,903
TOTAL EQUITY AND LIABILITIES 63,099 149,594 98,681

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, 2023 1,132 1,016,369 -24,306 -749,392 243,803
Comprehensive income for the period -11,406 -260,419 -271,825
Transactions with owners in their
capacity as owners
New share issue 1,132 150,662 151,794
Issue costs -30,551 -30,551
Closing balance September 30, 2023 2,264 1,136,480 -35,712 -1,009,811 93,221
Comprehensive income for the period 22,789 -49,019 -26,230
Transactions with owners in their
capacity ac owners
Closing balance December 31, 2023 2,264 1,136,480 -12,923 -1,058,830 66,991
Comprehensive income for the period -1,195 -79,611 -80,806
Transactions with owners in their
capacity as owners
Reduction nominal value -906 906 0
New share issue 3,733 59,507 63,240
Issue costs -10,830 -10,830
Closing balance September 30, 2024 5,091 1,186,063 -14,118 -1,138,441 38,595

Consolidated cash flow statement, summary

2024 2023 2024 2023 2023
SEK thousands NOTE Jul-Sep Jul-Sep Jan-Sep Jan-Sep Full year
Operating activities
Operating earnings/loss -31,228 -38,889 -79,292 -273,053 -296,459
Adjustment for items not included in cash
flow 12,766 2,481 17,318 138,720 140,522
Interest received 238 968 969 2,206 2,912
Interest paid -1,547 -272 -1,844 -918 -1,166
Tax paid 0 0 0 0 0
Cash flow from operating activities before
changes in working capital -19,771 -35,712 -62,849 -133,045 -154,191
Cash flow from changes in working capital
Change in inventory 0 16 0 2,036 1,995
Change in operating receivables 1,887 793 42 1,704 4,730
Change in operating liabilities 539 -666 -5,668 10,736 409
Cash flow from operating activities -17,345 -35,569 -68,475 -118,569 -147,057
Investment activities
Investment in intangible assets 0 0 0 -1,061 -1,061
Sale of fixed assets 0 0 0 0 1,329
Other long term receivables 0 39 0 3,547 2,929
Cash flow from investment activities 0 39 0 2,486 3,197
Financing activities
Amortization of leasing liability -2,872 -1,663 -6,555 -4,857 -6,500
New share issue 52,411 0 52,411 121,243 121,243
Newly taken out loans 0 0 14,500
Amortization of loans -14,500 0 -14,500 0 0
Cash flow from financing activities 35,039 -1,663 45,856 116,386 114,743
Cash flow for the period 17,694 -37,193 -22,619 303 -29,117
Cash and cash equivalents at start of
period 36,755 143,878 76,788 106,041 106,041
Exchange rate difference in cash and cash
equivalents -245 -8 35 333 -136
Cash and cash equivalents at end of
period
54,204 106,677 54,204 106,677 76,788

Consolidated key indicators

2024 2023 2024 2023 2023
Jul-Sep Jul-Sep Jan-Sep Jan-Sep Full year
Operating earnings/loss (SEK 000) -31,228 -38,889 -79,292 -273,054 -296,460
Earnings/loss for the year (SEK 000) -51,068 -38,556 -79,611 -260,419 -309,438
Earnings per share before dilution (SEK) -0.73 -0.91 -1.49 -7.99 -7.95
Earnings per share after dilution (SEK) -0.73 -0.91 -1.49 -7.99 -7.95
R&D expenses (SEK 000) -9.116 -6.715 -11.867 -24,147 -28,207
R&D expenses as percentage of operating
expenses (%)
29 13 25 14 9
Cash and cash equivalents at the period's end
(SEK 000)
54,204 106,677 54,204 106,677 76,788
Cash flow from operating activities (SEK 000) -17,345 -35,569 -68,475 -118,569 -147,057
Cash flow for the period (SEK 000) 17,694 -37,193 -22,619 303 -29,117
Equity (SEK 000) 38,595 93,221 38,595 93,221 66,991
Equity per share (SEK) 0.23 2.90 0.23 2.06 1.48
Equity / assets ratio (%) 61 62 61 62 68
Average number of employees 9 32 10 38 32
Average number of employees in R&D 6 4 4 8 7

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 2024 2023 Full year
Jul-Sep Jul-Sep Jan-Sep Jan-Sep 2023
235 417 476 12,799 12,977
76 91 623 172 228
311 508 1,099 12,971 13,205
0 0 0 -3,948 -3,948
-15,003 -14,030 -40,055 -41,197 -51,321
-1,737 -7,178 -8,476 -32,949 -37,309
-369 -582 -1,108 -133,556 -134,186
-2,928 -73 -3,088 -482 -389
-20,037 -21,863 -52,727 -212,132 -227,152
-19,726 -21,355 -51,628 -199,161 -213,948
6,552 -24,982 -35,748 -94,999 -75,858
-15,732 3,440 9,436 20,358 12,130
-1,421 -357 -1,421 -357 -15,074
-10,601 -21,899 -27,733 -74,998 -78,802
-30,327 -43,254 -79,361 -274,159 -292,750
-30,327 -43,254 -79,361 -274,159 -292,750
0 0 0 0 0
-30,327 -43,254 -79,361 -274,159 -292,750

Parent company's comprehensive income, summary

2024 2023 2024 2023 2023
SEK thousands NOTE Jul-Sep Jul-sep Jan-Sep Jan-Sep Full year
Earnings/loss for the period -30,327 -43,254 -79,361 -274,159 -292,750
Other earnings/loss for the period 0 0 0 0 0
Comprehensive income for the period -30,327 -43,254 -79,361 -274,159 -292,750

Parent company's balance sheet, summary

2024 2023 2023
SEK thousands
NOTE
Sep 30 Sep 30 Dec 31
ASSETS
Fixed assets
Intangible fixed assets 1,370 1,728 1,639
Tangible fixed assets 2 60 5,594 3,764
Financial fixed assets 303 328 303
Total fixed assets 1,733 7,650 5,706
Current assets
Account receivables 0 0 146
Receivables from Group companies 158 685 660
Current receivables 1,254 2,545 782
Prepaid expenses and accrued income 1,136 3,418 2,203
Cash and cash equivalents 49,819 92,647 71,090
Total current assets 52,367 99,295 74,881
TOTAL ASSETS 54,100 106,945 80,587
EQUITY AND LIABILITIES
Equity
Restricted equity
5,091 2,264 2,264
Total equity and liabilities 5,091 2,264 2,264
Non-restricted equity
Premium fund 52,411 120,111 0
Retained earnings including comprehensive income -21,520 -40,851 60,669
Total non-restricted equity 30,891 79,260 60,669
Total equity 35,982 81,524 62,933
Provisions
Other provisions 2 7,265 0 0
Total Provisions 7,265 0
Current liabilities 0
Other liabilities 10,853 25,421 17,654
Total current liabilities 10,853 25,421 17,654
TOTAL EQUITY AND LIABILITIES 54,100 106,945 80,587

Parent company's cash flow statement, summary

2024 2023 2024 2023 2023
SEK thousands NOTE Jul-Sep Jul-Sep Jan-Sep Jan-Sep Full year
Operating activities
Operating earnings/loss -19,726 -21,355 -51,628 -199,161 -213,948
Adjustment for items not included in cash flow 3,234 592 3,972 133,566 134,181
Interest received 238 944 968 2,182 2,880
Interest paid -1,421 0 -1,421 0 -5
Tax paid 0 0 0 0
Cash flow from operating activities before
changes in working capital -17,675 -19,819 -48,109 -63,413 -76,892
Cash flow from changes in working capital
Change in inventory 0 0 0 1,546 1,546
Change in operating receivables -7,107 -22,473 -26,037 -77,136 -78,801
Change in operating liabilities 4,946 1,343 464 7,515 -227
Cash flow from operating activities -19,836 -40,949 -73,682 -131,488 -154,374
Investment activities
Investment in intangible fixed assets 0 0 0 -1,061 -1,061
Sale of fixed assets 0 0 0 0 1,329
Cash flow from investment activities 0 0 0 -,1,061 268
Financing activities
New share issue 52,411 0 52,411 121,243 121,243
Newly taken out loans 0 0 14,500 0,
Amortization of loans -14,500 0 -14,500 0 0
Cash flow from financing activities 37,911 0 52,411 121,243 121,243
Cash flow for the period 18,075 -40,949 -21,271 -11,306 -32,863
Cash and cash equivalents at start of period 31,744 133,597 71,090 103,953 103,953
Cash and cash equivalents at period's end 49,819 92,647 49,819 92,647 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 2023 annual report.

This interim report has been prepared in accordance with IAS 34 interim finacial reporting.

New and amended standards adopted with effect from 2024 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 third quarter of 2024 refer only to royalties. The same applies to the period January-September 2024.

Transactions with related parties

From time to time, board members undertake specific assignments that do not belong to the board's normal duties, which are either decided at the annual general meeting or by the board jointly. No transactions have taken place during January-September 2024.

Leases and provisions

The group has leasing agreements, mainly in the form of agreements for the use of office premises, where one of the agreements extends to 31 October 2028 with a quarterly fee of approximately MSEK 1.6.

With the decision to cease commercialization of the IMMray® PanCan-d test and to wind down operations, there was a need to renegotiate said lease as of December 31, 2023. Based on a signed Letter of Intent with the landlord, with the mutual intent and likely outcome that the long-term rental agreement will be terminated, a revaluation of the agreement was made as of December 31, 2023, with a revaluation effect that meant that the right-of-use asset and the right-of-use liability decreased by approx. MSEK 20. The remaining right-of-use asset and leasing liability were reported as of December 31, 2023 based on a calculated and assessed probable leasing obligation, which meant a right-of-use asset and leasing liability of approximately MSEK 8. At the end of September 2024, these premises are no longer in use. The Letter of Intent with the landlord remains. Due to the fact that the group no longer uses of the premises, the remaining lease liability of approx. MSEK 5 has been reclassified to Other provision as of September 30, 2024. After a reassessment of the likely outcome of the contract, the total Other provision are reported at MSEK 7.3 and thus corresponds to an assessment of the likely outcome based on the Letter of Intent with the landlord. Remaining unreserved, undiscounted, value of the contract amounts to approx. MSEK 17.0. The parent company reports the corresponding provision.

Remaining lesing debt for other leasing agreements, is included in other interest-bearing liabilities and amounts to approximately MSEK 1.5 and refers to leasing contracts in the USA. New existing contracts in Sweden fall under short-term contracts and contracts of reduced value.

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

IInterest rate risk is the risk that the value of financial instruments varies due to changes in market interest rates. The group currently only has interest-bearing financial assets in the form of bank balances and interest-bearing liabilities in the form of leasing debt for premises. During the period, the group had a deposit of MSEK 14.5.The loan was obtained in quarter 2 and has been repaid in quarter 3. Interest has been paid at MSEK 1.4.

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 30 September 2024 to TSEK 55,532 (108,539).

Liquidity risk and going concern

With a cash balance of SEK 54 million end of the third quarter, together with estimated net proceeds from the warrants of series TO 2 and TO 3, Immunovia should be able to fund working capital needs for the coming twelve-month period.

Parent company

In order to reflect the impact of market penetration and insurance compensation in the USA in the financial reporting, it has been decided that the parent company must continuously write down the receivables that arise from the company's lending to the subsidiary Immunovia Inc. The profit effect accumulated as of 2024-09-30 amounts to MSEK -35.7. As an intra-group transaction, it has no impact on group reporting.

19

OTHER INFORMATION

Review

This interim report has been reviewed by the company's auditors.

Financial calendar

Financial statement 2024, Tuesday February 25, 2025. Q1 interim report 2025, Wednesday May 14, 2025. Q2 interim report 2025, Thursday August 21, 2025. Q3 interim report 2025, Wednesday November 19, 2025. Financial statement 2025, Tuesday February 24, 2026.

Annual General meeting

Friday May 14, 2025. Annual Report 2024 will be available from second week of April.

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 November 27, 2024.

Conference call

Immunovia will hold a webcast teleconference at 15:00 CET on November 27, 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: https://link.edgepilot.com/s/14ea2b56/FUDVjQ3oXkGNVm8Ehve33w?u=https://creo-live.creomediamanager.com/0cb413c2-e586-432a-8ccd-449b18e56ee0

20

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 November 27, 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

INTERIM REPORT JAN-SEP 2024 IMMUNOVIA – EARLY DETECTION

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.

22

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.

Pancreatologist – Doctor specializing in diseases relating to the pancreas.

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.

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

INTERIM REPORT JAN-SEP 2024 IMMUNOVIA – EARLY DETECTION

Scheelevägen 8, Medicon Village 223 63 Lund, Sweden

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