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Immunovia

Quarterly Report Nov 12, 2020

3061_ir_2020-11-12_a82cd5a8-a56b-4aa5-ac74-84900f255f71.pdf

Quarterly Report

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IMMUNOVIA AB (PUBL) Interim Report Jan-Sep 2020

Interim Report January-September 2020

Key indicators

-

SEK thousand unless otherwise stated 2020
Jul-Sep
2019
Jul-Sep
2020
Jan-Sep
2019
Jan-Sep
2019
Full Year
Net sales 37 92 210 311 356
Operating earnings -35,432 -27,927 -96,232 -84,666 -114,248
Earnings before tax -38,064 -25,625 -99,914 -81,903 -114,517
Net earnings -38,064 -25,625 -99,914 -81,906 -114,521
Earnings per share before dilution (SEK) -1.68 -1.31 -4.78 -4.19 -5.85
Earnings per share before after dilution (SEK) -1.68 -1.31 -4.78 -4.19 -5.85
Equity ratio (%) 91 87 91 87 85
Number of shares at the end of the period 22,603,081 19,654,853 22,603,081 19,654,353 19,654,853

Significant events July – September

Immunovia presented at the European Pancreatic Club (EPC), International Association of Pancreatology (IAP) annual meeting on July 2, 2020.

Change of CEO announced. Immunovia appointed Patrik Dahlen as the new CEO as of November 1, 2020. He has extensive experience as the former CEO of several diagnostic companies in Europe and the USA and succeeds Mats Grahn, who for the past seven years has successfully guided the company from the development phase to becoming a commercial company.

Hosted Webinar 2 in the series on IMMray™ PanCan-d: Results from CTMS, "Commercial Test Model Study" and update of launch activities.

Extraordinary General Meeting held on September 23, 2020. The Meeting resolved on the election of the current, but outgoing, CEO Mats Grahn as a new member of the Board of Directors.

The Meeting resolved to update the Annual General Meeting decision concerning remuneration of Board members, according to which each of the Board members will receive SEK 240,000, and the Chairman of the Board SEK 550,000. The Chairman of the Audit Committee and of the Remuneration Committee will each receive SEK 50,000 and other members of the aforementioned Committees SEK 30,000.

EARLY DETECTION

The Meeting resolved on the issue, with a deviation from shareholders' preferential rights, of not more than 450,000 warrants within the framework of an incentive scheme for key persons in the company, and authorized the Board to introduce an alternative cash-based incentive scheme for key persons in countries where the allocation of warrants is not appropriate.

Announced positive results from the IMMray™ PanCan-d verification study. The verification study shows results in line with the previous commercial test model study (CTMS), which paves the way for the final blind validation study.

Significant events January – June

Immunovia strengthened its management team with a new Senior Vice President of Sales NA (North America), Michael Pettigrew.

Implemented decisive action against the COVID-19 pandemic and updated the company's measures to support patients, staff, and public health initiatives in response to the COVID-19 pandemic caused by the coronavirus.

Temporarily closed Immunovia Dx Laboratories in Marlborough, Massachusetts, USA, due to the governor of Massachusetts' extended State of Emergency due to COVID-19. As a result, Immunovia has postponed sales launch until Q4 2020.

Reopened Immunovia Dx Laboratories in Marlborough, Massachusetts, on May 25, 2020.

Ended collaboration with a global pharmaceutical company in connection with a lung cancer study. Immunovia received all the fresh blood samples needed from the pharmaceutical partner in and will continue the research on its own.

Immunovia announced long-term market penetration targets for IMMray™ PanCan-d of 30% after cost reimbursement and broad insurance coverage has been obtained.

Immunovia successfully executed a new directed share issue of 2,948,228 shares corresponding to approximately SEK 400 million, one of the largest ever capital-raising actions for a diagnostic company based outside the USA. The proceeds from the directed new issue will be used for commercialization activities in conjunction with the launch of IMMray™ PanCan-d, our top priority. These activities include expanding the company's sales, marketing, and customer service departments. The accelerated book building process was carried out by Kempen & Co, Danske Bank and Vator Securities.

Immunovia expanded its lung cancer program based on promising results from the current research study. The next step in the expansion is a study with a larger cohort of new lung cancer samples that best reflects the commercial environment.

Immunovia announced long-term market penetration targets for IMMray™ PanCan-d of 30% after cost reimbursement and broad insurance coverage has been obtained.

Significant events after the period's end

Immunovia announced the completion of the IMMray™ PanCan-d verification study. The results showed outstanding accuracy of 94% in the differentiation of PDAC patients from healthy control subjects and 91% in the differentiation of early stages I/II of PDAC compared to all control subjects. The control subjects consisted of patients with nonspecific but concerning symptoms, including type II diabetics, and healthy individuals.

Immunovia announced a revision to its sales start. Due to the effect of COVID-19 in the USA, UK, Germany and Spain, patient flow at the sample collection centers fell significantly. The previously agreed sample collection rate and the collection of the additional samples needed to complete the validation stu¬dy in accordance with previously communicated timeline for Q4 2020 was affected. Based on the current impact of COVID-19 on sample collection, the company is aiming to start sales at the end of Q1, with subsequent commercial diagnostics during Q2.

CEOs' Statement

The most important event during Q3 was that we announced positive results from the IMMrayPanCan-d verification study. The analysis from the verification study showed results in line with the previous commercial test model study (CTMS) and was the beginning of the last stage towards CLIA-CAP accreditation in the USA, the final blind validation study.

Q3 started with a virtual presentation by Immunovia's Thomas King, MD, Ph.D. and Laura Chirica, Ph.D., at the annual meeting of the International Association of Pancreatology (IAP) at the European Pancreatic Club (EPC) on July 2, 2020, one of the most important events in the world in the field of pancreatic cancer. Immunovia's representatives were invited to present an update on the IMMray™ PanCan-d test. This presentation was attended by specialist doctors and was very well received.

In July, we also launched the "Immunovia Walk Around the World to Raise Awareness for Pancreatic Cancer", an initiative to raise awareness of pancreatic cancer. Participation in this event has been extremely pleasing and it has been very satisfying to see and hear all the photographs and videos that the participants have shared so far. We will continue to walk around the world until "World Pancreatic Cancer Day" which this year falls on November 19. By the end of the quarter, we had walked about 25,000 km, and over 1,500 people had visited the registration page from over 25 countries worldwide.

In early September, the second webinar in the IMMray™ PanCan-d series was hosted with Linda Mellby, Ph.D., Thomas King, MD, Ph.D. and Laura Chirica, Ph.D., who gave a more detailed presentation of the results of the Commercial Test Model Study (CTMS) as well as an update of all our launch activities. A replay of the webinar is available on our website.

Throughout the quarter, we recruited new staff to the Immunovia team in preparation for the start of sales. Our marketing activities have also intensified.

We announced the appointment of Patrik Dahlen as our new CEO starting on November 1, 2020, and that Mats Grahn will continue as a board member. This was confirmed at Immunovia's Extraordinary General Meeting held on September 23, 2020.

As I now begin my new role as a board member of Immunovia, I want to state how incredibly proud I am of what we have achieved, not only during Q3 this year, but from Immunovia's humble beginnings until the present day.

I am pleased to hand over the baton to Patrik Dahlen, who I have known for a long time and who is one of the most experienced leaders in the international diagnostics industry. Patrik is not only a highly respected business leader with wide-ranging international experience and knowledge of the international diagnostics industry, but he also knows Immunovia well, from the ground up, as he was one of our board members during the initial years.

Mats Grahn, Outgoing CEO and current board member of Immunovia AB

It feels really good to hand over the baton to Patrik Dahlen, who I have known for a long time and who is one of the most experienced leaders in the international diagnostics industry.

I am honored to come to Immunovia during this crucial and exciting time in the company's history.

Patik Dahlen, CEO, Immunovia AB

I am honored to join Immunovia during this pivotal and exciting time in the company's history. I believe that Immunovia is in a position to evolve into a dominating market leader for the bloodbased diagnosis of pancreatic cancer and I look forward to the exciting times to come in the company's development.

I would like to emphasize that Immunovia continues to have the goal of a long-term market penetration of 30% after reimbursement and widespread coverage has been achieved. The current size of the addressable market for IMMray™ PanCan-d is estimated to exceed USD 4 billion in the EU and the USA, across the three risk groups the company targets: hereditary/familial, differential diagnosis of early symptoms and newly diagnosed diabetes in individuals over 50. We look forward to continuing to work with healthcare operators around the world.

On behalf of the Board and the entire Immunovia team, I thank you for your continued support of Immunovia's efforts to contribute to having a positive impact on the lives of those at risk from pancreatic cancer.

Patrik Dahlen, CEO, Immunovia AB

Table of contents

Group's performance over the period 5
Share information6
Incentive scheme7
Consolidated income statement in summary 8
Consolidated comprehensive income in summary 8
Consolidated financial position in summary 9
Change in consolidated equity in summary 10
Consolidated cash flow statement in summary 11
Consolidated key indicators 12
Definitions 13
Parent company's income statement in summary 14
Parent company's comprehensive income in summary 14
Parent company's balance sheet in summary 15
Parent company's cash flow statement in summary 16
Accounting principles 17
Auditor's review of the interim report 20
Glossary 21
Immunovia inbrief 23

About the report This information was submitted for publication on November 12 2020, 16,00 pm.

This financial statement has been produced in accordance with IFRS for the Immunovia Group, which comprises Immunovia AB and the wholly-owned subsidiaries Immunovia Incentive AB, Immunovia Inc. and Immunovia GmbH.

Contact Immunovia AB (publ), Medicon Village, Scheelevägen 8, 223 63 Lund; Sweden • +46 46-2756 000 • [email protected]

For further information please contact Julie Silber, Director of Investor Relations • [email protected] Tel: +46(0)79 3486277

january-september 2020 The Group's performance over the period

Net sales

• Net sales for Q3 2020 were SEK 37,000 (92). Sales for the period January-September 2020, were SEK 210,000 (311). Sales mainly consist of royalties.

During Q3 2020, capitalized costs totaled SEK 8,09 million (6.45). Capitalized costs during the period January-September amounted to SEK 30.37 million (18.59). As capitalized costs are financed with approved and paid contributions, they are written-down directly by the corresponding amount. During the period January-September 2020, no contributions for development costs were received. During the corresponding period last year SEK 291,000 in contributions were received.

Earnings

• The net loss for Q3 2020 was SEK 38.06 million (-25.63. The loss for the period January-June 2020 was SEK 99.91 million (-81.91). The net loss for Q3 2020 is higher due to increased costs, which primarily result from increased development efforts as well as increases in marketing and launch activities. Other external and personnel costs rose by a total of SEK 22.07 million during the period January to June compared to the corresponding period last year and amounted to SEK 119.33 million in total.

Research & Development

• Research & Development efforts follow the established plans. Total R&D costs for Q3 2020 amounted to SEK 9.1 million (8.35), corresponding to 21% (24%) of the Group's operating expenses.

Financing and cash flow

• The cash flow from operating activities for Q3 was SEK -33.27 million (-31.20). Corresponding cash flow for the period January-September 2020 was SEK -84.95 million (-69.31). Cash and cash equivalents on September 30, 2020 was SEK 510.59 million (297.22).

Equity at the end of the period amounted to SEK 633.07 million (388.01) and the equity/assets

The management believes that there is sufficient working capital to cover working capital needs, given the current business and development plan, for around 2.5 years ahead.

Investments

• In Q3 2020, intangible assets totaling SEK 8.83 million (7,54) were acquired, consisting of capitalized development expenditure of SEK 8.09 million (6.45), patents SEK 489,000 (1.09 m) and SEK 244,000 (0) on other intangible assets.

During the period January-September 2020, intangible assets totaling SEK 33.39 million (21.52) were acquired, consisting of capitalized development expenditure of SEK 30.37 million (18.59), patents SEK 1.56 million (2.93) and SEK 1.47 million (0) on other intangible assets.

Investments in tangible fixed assets in the form of inventory were made during Q3 020 SEK 2.19 million (SEK 771.000). For the period January-September 2020, investments were made in tangible fixed assets of SEK 3.31 million (4.93).

No investments in financial assets were made during the period January-September.

Employees

• The average number of employees in the Group during Q3 2020 was 63 (48) and at the end of the period the number of employees was 67 (49).

Share information

The number of registered shares amounted to 22,603,081 at the end of the reporting period. The share's nominal value is SEK 0.05.

Share capital's development
Year Event Total share
capital (SEK
Change
(SEK)
Total no. of
shares
Change in
shares
Nominal
value (SEK)
May 24, 2007 Formation 100,000,00 100,000.00 1,000,000 1,000,000 0.10
Oct 19, 2011 New share issue 105,263.00 5,263.00 1,052,630 52,630 0.10
Oct 27, 2011 Share split 5:1 105,263.00 - 5,263,150 4,210,520 0.02
July 5, 2012 New share issue 108,869.92 3,606.92 5,443,496 180,346 0.02
May 21, 2013 New share issue 122,483.76 13,613.84 6,124,188 680,692 0.02
Sep 10, 2013 New share issue 124,899.76 2,416.00 6,244,988 120,800 0.02
Jun 5, 2014 New share issue 220,924.32 96,024.56 11,046,216 4,801,228 0.02
Aug 13, 2015 Bonus issue 552,310.80 331,386.48 11,046,216 - 0.05
Dec 17, 2015 New share issue 714,560.80 162,250.00 14,291,216 3,245,000 0.05
Sep 15, 2016 New share issue 823,728.40 109,167.60 16,474,568 2,183,352 0.05
Oct 17, 2016 New share issue 840,202.95 16,474.55 16,804,059 329,491 0.05
Oct 4, 2017 New share issue
via warrants
865,902.95 25,700.00 17,318,059 514,000 0.05
Jun 8, 2018 New share issue 974,042.65 108,139.70 19,480,853 2,162,794 0.05
Sep 19, 2018 New share issue
via warrants
976,567.65 2,525.00 19,531,353 50,500 0.05
Sep 9, 2019 New share issue
via warrants
982,742.65 6,175.00 19,654,853 123,500 0.05
Jun 4, 2020 New share issue 1,130,154.05 147,411,40 22,603,081 2,948,228 0.05
At end of period 1,130,154.05 22,603,081 0.05

The 10 largest shareholders on September 30, 2020

Namn No. of shares Share (capital and votes)
Carl Borrebaeck 1,709,900 7.56%
Ålandsbanken on behalf of the owner 1,692,312 7.49%
Handelsbanken Svenska Småbolag 1,200,000 5.31%
Swedbank Robur Folksams LO Sverige 1,075,000 4.76%
Bank New York Mellon SA/NV 937,653 4.15%
Per Mats Ohlin 888,950 3.93%
Sara Andersson Ek 852,907 3.77%
Christer Wingren 757,152 3.35%
Försäkringsbolaget Avanza Pension 666,415 2.95%
Vincent Saldell 650,630 2.88%
Ten largest owners 10,430,919 46.15%
Others 12,172,162 53.85%
Total 22,603,081 100.00 %

Incentive schemes

Immunovia has four outstanding warrant schemes comprising 746,650 warrants with the right to subscribe for 46,650 shares. There is no dilution effect on earnings per share as long as the Group's earnings are negative.

Warrant schemes

The warrant schemes 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 schemes

In countries where the allotment of warrant schemes is not appropriate for various reasons, it has been decided to introduce alternative cash-based incentive schemes for employees and key personnel in the company. The alternative incentive schemes are designed in such a way that their financial effect corresponds to the terms of the corresponding warrant scheme. The total cost to the company for the cash-based incentive schemes is shown in the breakdown below.

All warrant schemes are subject to customary recalculation terms in connection with share issues, etc.

Breakdown of outstanding incentive schemes

Subscription
period/measuring
Number of
outstanding
Subscrip
tion price/
Change in
share capital at
Total cost of
alternative
cash-based
incentive
Incentive scheme Decision date period warrants share full utilization schemes (USD)
Warrant scheme
2017/2020
Apr 25, 2017 Sep 15, 2020 –
Oct 15, 2020
61,000 205.00 3,050.00
Warrant scheme
2018/2021
May 3, 2018 Sep 7, 2021 –
Oct 7, 2021
156,150 271.05 7,807.50
Warrant scheme
2019/2023
Apr 26, 2019 Jun 1, 2023 –
Jun 30, 2023
79,500 342.06 3,975.00
Warrant scheme
2020/2024
Sep 23, 2020 Jun 1, 2024 –
Jun 30, 2024
450,000 455.59 22,500.00
Alternative cash
based incentive
scheme 2017/2020
Apr 25, 2017 Sep 15, 2020-
Oct 15, 2020
920,000
Alternative cash
based incentive
scheme 2018/2021
May 3, 2018 Sep 7, 2020-
Oct 7, 2021
250,000
Alternative cash
based incentive
scheme 2019/2023
Apr 26, 2019 Jun 1, 2023 –
Jun 30, 2023
520,000
Alternative cash
based incentive
scheme 2020/2024
Sep 23, 2020 Jun 1, 2024 –
Jun 30, 2024
795,000
Total 746,650 35,707.50 2 485,000

The alternative cash-based incentive scheme of 2017/2020 has charged the current period with USD 640,000 in costs, which will have an additional impact of USD 280,000 in costs in Q4 2020.

SEK thousands 2020
Jul-Sep
2019
Jul-Sep
2020
Jan-Sep
2019
Jan-Sep
2019
Full Year
Operating income etc
Net sales 37 92 210 311 356
Other operating income 63 117 299 397 458
Total 100 209 509 708 814
Operating expenses
Other external expenses -20,759 -19,737 -70,017 -57,967 -78,320
Personnel costs -20,305 -12,464 -49,311 -39,287 -54,576
Capitalized work for own account 8,097 6,448 30,372 18,591 26,716
Amortization of tangible and intangible
assets -2,444 -2,114 -7,313 -6,276 -8,447
Other opreating expenses -121 -269 -471 -435 -435
Total operating expenses -35,532 -28,136 -96,740 -85,374 -115,062
Operating earnings/ loss -35,432 -27,927 -96,232 -84,666 -114,248
Profit/loss from financial items
Financial income 237 2,626 5,465 3,767 3,820
Financial expenses -2,869 -324 -9,147 -1,004 -4,089
Total financial items -2,632 2,302 -3,682 2,763 -269
Earnings/loss after financial items -38,064 -25,625 -99,914 -81,903 -114,517
Income tax 0 0 0 -3 -4
Earnings/loss for the period -38,064 -25,625 -99,914 -81,906 -114,521
Earnings per share before dilution (SEK) -1.68 -1.31 -4.78 -4.19 -5.85
Earnings per share after dilution (SEK)) -1.68 -1.31 -4.78 -4.19 -5.85
Average number of shares 22,603,081 19,558,797 20,910,580 19,540,501 19,569,089
Number of shares at year's end 22,603,081 19,654,853 22,603,081 19,654,853 19,654,853

Consolidated income statement in summary

Consolidated comprehensive income in summary

2020 2019 2020 2019 2019
SEK thousands Jul-Sep Jul-Sep Jan-Sep Jan-Sep Full Year
Earnings/loss for the period -38,064 -25,625 -99,914 -81,906 -114,521
Items that may be reclassified later
in the income statement
Exchange rate differences for
foreign net investment
2,380 -1,947 2,708 -2,588 -409
Other earnings/loss for the period 2,380 -1,947 2,708 -2,588 -409
Comprehensive income for the
period - 35,684 -27,572 -97,206 -84,494 -114,930

Consolidated financial position in summary

2020 2019 2019
SEK thousands Sep 30 Sep 30 Dec 31
ASSETS
Fixed assets
Intangible fixed assets 125,014 82,923 91,860
Tangible fixed assets 51,225 55,358 55,224
Financial fixed assets 3,014 3,292 3,124
Total fixed assets 179,253 141,573 150,208
Current assets
Accounts receivable 0 219 0
Current receivables 7,243 6,333 5,813
Cash and cash equivalents 510,593 297,217 263,345
Total current assets 517,836 303,769 269,158
TOTAL ASSETS 697,089 445,342 419,366
EQUITY AND LIABILITIES
Equity
Share capital 1 130 983 983
Other contributed capital 1,009,450 636,896 636,924
Translation reserve 1,705 -3,182 -1,002
Retained earnings incl. total comprehensive income -379,214 -246,685 -279,301
Total equity 633,071 388,012 357,604
Long-term liabilities
Interest-bearing liabilities 30,900 34,689 33,121
Total long-term liabilities 30,900 34,689 33,121
Current liabilities
Interest-bearing liabilities 3,475 3,323 4,945
Other liabilities 29,643 19,318 23,696
Total current liabilities 33,118 22,641 28,641
TOTAL EQUITY AND LIABILITIES 697,089 445,342 419,366

SEK thousands

Items that may be reclassified later in the income statement Exchange rate differences for

Comprehensive income for the

2020 Jul-Sep

2019 Jul-Sep

Earnings/loss for the period -38,064 -25,625 -99,914 -81,906 -114,521

foreign net investment 2,380 -1,947 2,708 -2,588 -409 Other earnings/loss for the period 2,380 -1,947 2,708 -2,588 -409

period - 35,684 -27,572 -97,206 -84,494 -114,930

2020 Jan-Sep

2019 Jan-Sep

2019 Full Year

Accumulated
earnings/loss
Share Other paid Reser Inc. earnings/
loss for the
SEK thousands capital up equity l ves period Total equity
Opening balance January 1, 2019 977 626,348 -593 -164,780 461,953
Comprehensive income for the
period
-2,589 -81,906 -84,495
Transactions with owners in their
capacity as owners
Deposited share warrant premiums 316 316
New share issue 6 10,232 10,238
Closing balance Sep 30, 2019 983 636,896 -3,182 -246,686 388,012
Comprehensive income for the
period
2,180 -32,615 -30,435
Transactions with owners in their
capacity as owners
Deposited share warrant premiums 28 28
Closing balance Dec 31, 2019 983 636,924 -1,002 -279,301 357,604
Comprehensive income for the
period
2,707 -99,913 -97,206
Transactions with owners in their
capacity as owners
New share issue 147 397,863 398,010
Share issue costs -25,337 -25,337
Closing balance Sep 30, 2020 1,130 1,009,450 1,705 -379,214 633,071

Change in consolidated equity in summary

Consolidated cash flow statement in summary

2020 2019 2020 2019 2019
SEK thousands Jul-Sep Jul-Sep Jan-Sep Jan-Sep Full Year
Operating activities
Operating earnings/loss -35,432 -27,927 -96,231 -84,666 -114,249
Adjustment for items not included in cash
flow
2,507 2,200 7,280 6,370 8,444
Interest received 237 55 350 231 284
Interest paid -348 -324 -1,079 -1,004 -1,315
Tax paid 0 0 0 -3 -4
Cash flow from operating activities befo
re changes in working capital
-33,036 -25,996 -89,680 -79,072 -106,840
Cash flow from changes in working
capital
Change in operating receivables 108 -1,292 -1,501 5,896 6,620
Change in operating liabilities -338 -3,908 6,234 3,868 8,266
Cash flow from operating activities -33,266 -31,196 -84,947 -69,308 -91,954
Investment activities
Investment in Intangible assets -8,830 -7,539 -33,394 -21,521 -30,568
Investment in tangible assets -2,192 -771 -3,305 -4,927 -6,034
Investment in financial fixed assets 0 -1 0 -3 0
Cash flow from investment activities -11,022 -8,311 -36,699 -26,451 -36,602
Finansieringsverksamheten
Amortization of leasing liability -1,197 -1,339 -3,690 -4,073 -5,115
National and European grants for deve
lopment costs 0 0 0 291 291
New share issue
Received warrants premiums
0
0
10,238
316
372,673
0
10,238
316
10,238
344
Cash flow from financing activities -1,197 9,215 368,983 6,772 5,758
Cash flow for the period -45,485 -30,292 247,337 -88,987 -122,797
Cash and cash equivalents at start of
period
556,191 327,462 263,345 386,136 386,156
Exchange rate difference in cash and cash
equivalents
-113 47 -89 68 6
Cash and cash equivalents at end of
period
510,593 297,217 510,593 297,217 263,345

Consolidated key indicators

2020 2019 2020 2019 2019 2018
Jul-Sep Jul-Sep Jan-Sep Jan-Sep Full Year Full Year
Operating earnings/loss
(SEK 000)
-35,432 -27,927 -96,232 -84,666 -114,248 -87,709
Earnings/loss for the year
(SEK 000)
-38,064 -25,625 -99,914 -81,906 -114,521 -86,539
Earnings per share before
dilution (SEK)
-1.68 -1.31 -4.78 -4.19 -5.85 -4.67
Earnings per share after
dilution (SEK)
-1.68 -1.31 -4.78 -4.19 -5.85 -4.67
R&D expenses (SEK 000) -9,103 -8,350 -35,200 -23,493 -34,273 -26,048
R&D expenses as percentage
of operating expenses (%)
21 26 28 24 26 23
Cash and cash equivalents at
the period's end
(SEK 000) 510,593 297,217 510,593 297,217 263,345 386,136
Cash flow from operating
activities (SEK 000)
-33,266 -31,196 -84,947 -69,308 -91,954 -84,111
Cash flow for the period (SEK
000)
-45,485 -30,292 247,337 -88,987 -122,797 193,680
Equity (SEK 000) 633,071 388,012 668,755 388,012 357,604 461,953
Equity per share (SEK) 28.01 19.74 29.59 19.74 18.19 23.65
Equity per share (%) 91 87 91 87 85 97
Average number of
employees
63 48 60 48 48 39
Average number of
employees in R&D
22 19 22 18 19 17

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 outstan
ding shares in the period before
and after dilution respectively.
Because the group is generating
a loss, there is no dilution, despite
the subscription price being lower
than the share price.
R&D expenses The company's direct expenses for
research and development. 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
within the company.
R&D expenses as a
percentage of operating
expenses
R&D expenses divided by ope
rating expenses, which include
other external expenses, personnel
expenses, depreciation and amor
tization.
Management considers that the company's
R&D expenses in relation to total expenses
are an important indication of the propor
tion 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 equi
valents for the period excluding
effective unrealized exchange rate
gains and exchange rate losses.
Equity per share (SEK) Equity divided by the number of
shares.
Management follows this indicator to moni
tor 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 resear
ch and development functions.

Parent company's income statement in summary

SEK thousands 2020
Jul-Sep
2019
Jul-Sep
2020
Jan-sep
2019
Jan-Sep
2019
Full Year
Operating income etc.
Net sales 37 92 210 311 356
Capitalized work for own account 8,097 6,448 30,372 18,591 26,716
Other operating income 72 213 308 493 457
Total operating income 8,206 6,753 30,890 19,395 27,529
Operating expenses
Other external expenses -19,748 -19,613 -67,029 -56,649 -79,046
Personnel costs -8,769 -8,367 -29,484 -27,572 -38,326
Amortization of intangible and
tangible fixed assets -829 -736 -2,471 -2,157 -2,950
Other operating expenses -120 -269 -471 -435 -335
Total operating expenses -29,466 -28,985 -99,455 -86,813 -120,657
Operating earnings/loss -21,260 -22,232 -68,565 -67,418 -93,128
Operating expenses
Financial incomes 761 2,883 6,955 4,580 4,981
Financial expenses -2,522 0 -8,068 -2 -2,721
Total financial items -1,761 2,883 -1,113 4,578 2,260
Earnings/loss after financial items -23,021 -19,349 -69,678 -62,840 -90,868
Allocations
Group contributions received 0 0 0 0 337
Total allocations 0 0 0 0 337
Earnings/loss before tax -23,021 -19,349 -69,678 -62,480 -90,531
Income tax 0 0 0 0 0
Earnings/loss for the period -23,021 -19,349 -69,678 -62,840 -90,531

Parent company's comprehensive income in summary

2020 2019 2020 2019 2019
SEK thousands Jul-Sep Jul-Sep Jan-Sep Jan-Sep Full Year
Earnings/loss for the period -23,021 -19,349 -69,678 -62,840 -90,531
Other earnings/loss for the period 0 0 0 0 0
Comprehensive income for the period -23,021 -19,349 -69,678 -62,840 -90,531

Parent company's balance sheet in summary

2020 2019 2019
SEK thousands Sep 30 Sep 30 Dec 31
ASSETS
Fixed assets
Intangible fixed assets 123,494 81,920 90,907
Tangible fixed assets 11,887 11,885 12,257
Financial fixed assets
Total fixed assets
329
135,710
303
94,108
303
103,467
Current assets
Accounts receivable 0 219 0
Receivables from Group companies 78,151 51,976 53,579
Current receivables 3,150 2,639 3,254
Prepaid expenses and accrued income 3,586 4,504 3,416
Cash and cash equivalents 507,914 295,769 261,647
Total current assets 592,801 355,107 321,896
TOTAL ASSETS 728,511 449,215 425,363
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 1,130 983 983
Fund for development expenses 95,941 57,444 65,569
Total equity and liabilities 97,071 58,427 66,552
Non-restricted equity
Premium fund 372 526 322,478 10,232
Retained earnings including comprehensive income 235 856 49,243 325,673
Total non-restricted equity 608,382 371,721 335,905
Total equity 705,453 430,148 402,457
Current liabilities
Other liabilities 23,058 19,067 22,906
Total current liabilities 23,058 19,067 22,906
TOTAL EQUITY AND LIABILITIES 728,511 449,215 425,363

SEK thousands

2020 Jul-Sep

Earnings/loss for the period -23,021 -19,349 -69,678 -62,840 -90,531 Other earnings/loss for the period 0 0 0 0 0 Comprehensive income for the period -23,021 -19,349 -69,678 -62,840 -90,531

2019 Jul-Sep

2020 Jan-Sep

2019 Jan-Sep

2019 Full Year

Parent company's cash flow statement in summary

2020 2019 2019
SEK thousands Jan-Sep Jan-Sep Full Year
Operating activities
Operating earnings/loss -68,565 -67,417 -93,128
Adjustment for items not included in cash flow 2,471 2,157 2,950
Interest received 349 219 270
Interest paid -3 -2 -2
Tax paid 0 0 0
Cash flow from operating activities before chang
es in working capital -65,748 -65,043 -89,910
Cash flow from changes in working capital
Change in operating receivables -26,097 -12,654 -15,933
Change in operating receivables 152 3,865 8,042
Cash flow from operating activities -91,693 -73,832 -97,801
Investment activities
Investment in Intangible fixed assets -32,766 -21,521 -30,568
Investment in tangible fixed assets -1,922 -4,874 -5,980
Investment in financial fixed assets -25 -50 -50
Cash flow from investment activities -34,713 -26,445 -36,598
Financing activities
National and European grants for development
expenses
0 291 291
New share issue 372,673 10,238 10,238
Cash flow from financing activities 372,673 10,529 10,529
Cash flow for the period 246,267 -89,748 -123,870
Cash and cash equivalents at start of period 261,647 385,517 385,517
Cash and cash equivalents at period's end 507,914 295,769 261,647

Accounting principles

Accounting principles

The Group applies the Swedish Annual Accounts Act and International Financial Reporting Standards (IFRS) as adopted by the EU, and RFR 1 complementary accounting rules for Groups when preparing financial reports. The parent company applies the Swedish annual accounts act and RFR 2 Accounting for legal entities when preparing financial reports. The applied accounting principles are consistent with those applied in the 2019 annual report.

This interim report has been prepared in accordance with IAS 34 Interim Financial Reporting.

New and amended standards adopted with effect from 2020 are not expected to have any significant impact on the Group's financial position.

OTHER INFORMATION

Financial instruments

The Group currently has no financial instruments valued at fair value. Instead, all financial assets and liabilities are valued at accrued acquisition cost. It is estimated that there are no significant differences between fair value and book value relating to financial assets and liabilities.

Transactions with related parties

In addition to salaries and other remuneration to the executive management and board fees, according to a resolution by the AGM, the company has also entered into a consultancy agreement with CB Ocean Capital AB for services to be performed by Immunovia's chairman and its largest owner Carl Borrebaeck. The services provided do not include tasks that belong to board assignments, but the services are aimed at providing the company with scientific and strategic support for scientific presentations and conferences, for example. This agreement runs until further notice with three months' notice for both parties and remuneration per quarter amounts to SEK 41,000.

Risks

Immunovia is exposed to financial risks and business risks. Financial risk management and the financial risks are described below. The company's business risks are presented on page 39 of the 2019 annual report. In addition to the risks presented, the impact of the COVID-19 pandemic on the world's economy is currently difficult to predict, thus making it difficult to predict the general developments in Immunovia's future markets.

Market risk

Currency risk

The Group operates both nationally and internationally, which involves exposure to fluctuations in various currencies, in particular USD and EUR. Currency risk arises from future commercial transactions and recognized assets and liabilities. The scope of the company's operations currently means that net exposure in foreign currencies is limited. The company therefore does not have a currency hedging policy.

Interest risk in cash flow

Interest risk is the risk that the value of financial instruments will fluctuate due to changes in market interest rates. The Group currently only has interest-bearing financial assets in the form of bank deposits as well as interest-bearing liabilities in the form of leasing debt for premises

Credit risk

Credit risk is the risk of one party in a transaction with a financial instrument failing to meet its obligations. The maximum exposure to credit risk on financial assets as of Wednesday, September 30, 2020 was SEK 513.6 million (300.9).

Liquidity risk

Prudent liquidity risk management implies maintaining sufficient cash or agreed credit options to close market positions. Based on the existing business plan, there is enough liquidity for approximately 2.5 years ahead.

OTHER INFORMATION

Review

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

Financial calendar

Financial statement 2020, Wednesday February 17, 2021 Q1 interim report Wednesday April 28, 2021 Q2 interim report Thursday, August 19, 2021 Q3 interim report Thursday, November 11, 2021 Financial statement 2021, Thursday, February 17, 2022

Annual General Meeting

Thursday, May 6, 2021, 4.00 pm

Contact information:

Immunovia AB (publ), Medicon Village, Scheelevägen 8, 223 63 Lund, Sweden Tel: +46 46 2756 000 Email: [email protected] Web: www.immunovia.com For further information please contact

Telephone conference: November 12, 16.30 (CET)

Telephone numbers Sweden: +46 (0) 8 50520424 United States: +1 212 999 6659 France: +33 (0) 1 7037 7166 Denmark: +45 3272 9273 Germany: +49 (0) 30 3001 90612 Spain: +34 91 787 0777 Netherlands: +31 (0) 20 708 5073 Norway: +47 2 156 3318 Austria: +43 (0) 12530807 Switzerland: +41 (0) 22 592 7915

United Kingdom (standard international access): +44 (0) 20 3003

Conference Code: (to provide to the operator) Immunovia

Immunovia Webcast: https://channel.royalcast.com/immunovia/#!/immunovia/20201112_1

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 Group face.

Lund, November 12, 2020

Carl Borrebaeck Chairman

Hans Johansson Board member

Ann-Christine Sundell Board member

Christofer Sjögren Board member

Mimmi Ekberg Board member Peter Høngaard Andersen Board member

Mats Grahn Board member Patrik Dahlen CEO

Auditor's review of the interim report

To the Board of Immunovia AB (publ) org.no 556730-4299

I conducted a review of the summary of interim financial information (interim report) for Immunovia AB (publ) per September 30, 2019 and the nine-month period ending at that date. The Board of Directors and the CEO are responsible for the preparation and fair presentation of this interim report in accordance with IAS 34 and the Annual Accounts Act. My responsibility is to express a conclusion on this interim report based on my review.

Focus and scope of the review

I conducted my review in accordance with the International Standard on Review Engagements ISRE 2410, Review of financial interim information conducted by the company's chosen auditor. A reviewinvolves making inquiries, primarily to persons responsible for financial matters and accounting issues, conducting an analytical review and performing other review procedures. A review has a different focus and a significantly smaller scope than the focus and scope of a review in accordance with ISA and with generally accepted auditing practice. The review measures taken in a review do not allow us to obtain such a full understanding that we become aware of all the important circumstances that could have been identified if an audit was carried out. Therefore, the stated conclusion based on a review does not have the assurance that an expressed conclusion based on an audit has.

Conclusion

Based on my review, no circumstances have arisen which give me reason to believe that the interim report has not been prepared in essence for the Group in accordance with IAS 34 and the Annual Accounts Act, as well as for the Parent Company in accordance with the Annual Accounts Act.

Lund 12 November, 2020

Mats-Åke Andersson Authorized Public Accountant

Glossary

Antigen. Actionable information – Information that is sufficiently authoritative and specific to be used in clinical decision making.

Antibodies – Antibodies, or immunoglobulins, are a type of protein used by the body's immune system to detect and identify foreign substances such as viruses, bacteria or parasites.

Antigen – A foreign body substance that elicits a reaction of the immune system in contact with the organism. The substance may be a chemical substance, a protein or a carbohydrate.

Autoimmunity – Autoimmunity is the immune system's harmful attack on the body's own tissue, which can take the form of disease or rejection of organs during trans- plantation.

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 sub- stance. Biomarkers can be used as early warning signs of biological changes in an organism.

Companion Diagnostics – Diagnostics tools aimed at identifying which groups of patients will respond well to a particular treatment and thus ruling out ineffective treatments.

Discovery Trial – Research carried out in order to verify a special hypothesis.

Histology – Histology is the study of biological tissue.

Invasive – Invasive means to penetrate or attack. Invasive medical examinations refer to examinations that include any form of penetration through a hole in the body or surgical operation.

Malignant – Malignant tumors tend to worsen and become mortal. They are termed cancer, and thus differ from benign tumors.

Metastasis – A metastasis is a tumor that has spread to other organs.

Microarray – A microarray is a molecular biology test format for simultaneously measuring the relative concentrations of proteins.

Molecular Diagnosis – A collection of technologies used to analyze biological markers at the genomic and protein levels (i.e., the genetic code of individuals and how their cells express their genes as proteins in the body), using molecular biology for medical testing. These technologies are used to diagnose and monitor disease, detect the risk of disease and to determine which treatment is likely to work best for the individual.

NSCLC – Non-Small Cell Lung Cancer, the most common type of lung cancer, 80-85% of all lung cancer cases.

Palliative care – Palliative care is administered when the patient's disease is beyond the ability to cure. The purpose of palliative care is to provide support to patients and families using both psychological and medical practices.

PanDIA-1 – Prospective trial for the diabetes risk group of patients aged over 50 recently diagnosed with type-2 diabetes.

PanFAM-1 – Prospective trial for familiar and hereditary risk groups.

Pancreatologist – Doctor specializing in diseases relating to the pancreas.

PanSYM-1 – Prospective trial for early symptom risk groups.

Prospective trial – A trial in which a group of individuals is studied and followed often for a long time to see how a particular disease develops. A prospective trial is used to study the relationship between different risk factors and a certain disease. You follow individuals with and without risk factors going forwards over time. At the end of the trial, the proportion of individuals in the two groups who developed disease is compared.

Proteomics – Proteomics is a branch of biology and includes surveys of large amounts of data about proteins.

RA – Rheumatoid arthritis, one of the most common autoimmune diseases.

RA double negative – Patients who have RA, but test negative for it using the current two single-marker standard tests, RF factor and anti-CCP.

Reproducibility – Within the field of statistics, reproducibility is described as the correlation between results from repeated measurements performed by different observers with different instruments of the same type, which measurements are performed in order to reject any measurement error due to materials and personnel.

Retrospective study – A study in which the focus is on some- thing that has happened in the past, i.e. using historic data. This form of study starts with the answer, i.e. it is known which individuals became ill and which did not.

Screening – Screening refers to medical examinations to identify a disease. It is normally carried out before the patient has exhibited obvious symptoms.

Self-pay customers – Patients or organizations that pay without reimbursement from insurance companies or authorities.

Sensitivity – Sensitivity is a statistical measure of the reliability of a binary diagnostic test and the probability that a generated positive result is correct.

Serum – A serum is a transparent yellowish liquid obtained by allowing the blood to clot, and then removing the blood cells and the coagulation proteins. Serum contains proteins, including antibodies.

SLE (Systemic Lupus Erythematosus) – SLE is an autoimmune inflammatory disease which means that the immune system attacks the body. The symptoms come and go in cycles, sometimes the patient is sick and sometimes has no sickness at all. Usually it is the joints, skin, blood and kidneys which become inflamed, but also the nervous system, lungs and heart can be affected. The dis- ease is currently difficult to diagnose and is often confused with other autoimmune diseases.

Specificity – Specificity is a statistical measure of the reliability of a binary diagnostic test and the probability that the generated negative result is de facto negative.

Vinnova – Vinnova is a Swedish government agency under the Ministry of Industry which aims to promote sustainable growth by improving conditions for innovation and by funding needs-driven research.

Immunovia in brief

Immunovia is a Swedish molecular diagnostic company with a strong financial position in a commercial phase. The company develops and commercializes diagnostic tools for complex forms of cancer and autoimmune diseases.

Immunovia AB was founded in 2007 by researchers from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden. The purpose was to establish a base from which to make scientific discoveries and gain patents within the fields of human antibodies, biomarkers and antibody arrays, covering the stages from research to clinical application. Immunovia's core technology platform, IMMray™, is based on microarray analysis of biomarker antibodies. IMMray™ PanCan-d is the company's primary diagnostic tool, capable of diagnosing with a high level of sensitivity and specificity. This enables diagnosis of patients with pancreatic cancer before symptoms are noted (stages I and II), which is not currently possible with existing methods. Immunovia is now performing clinical validation studies to prepare for the commercialization of IMMray™ PanCan-d, which could become the first blood-based test for early diagnosis of pancreatic cancer. The antibody-based technology platform, IMMray®, is the result of 15 years of research at CREATE Health, Lund University. It is used to decode mechanisms behind the body's immune system, the first system in the body that reacts to disease. The platform can also be used for the development of diagnostic tests for autoimmune diseases.

Pancreatic cancer

Each year about 338,000 patients fall ill with pancreatic cancer. This form of cancer has one of the worst survival forecasts and only about 5% of diagnosed patients live more than five years, making it one of the deadliest cancers in the world. It is estimated that early detection would increase the five-year survival rate by around 50%. The initial addressable market for Immunovia consists of two high-risk pancreatic cancer groups. The market in the US and Europe for diagnosis of these groups is estimated to be worth over SEK 30 billion anually.

Goal

Immunovia's goal is to provide diagnostic tests that will enable earlier, more efficient and more accurate diagnosis of patients who run the risk of developing cancer or autoimmune disease. The aim is to make Immunovia's tests the first choice of specialist doctors and general practitioners across the world in the screening of especially high-risk groups or when there is a suspicion of the aforementioned diseases.

Strategy

Immunovia's strategy is as the first company, to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases earlier and more accurately than previously possible. The focus is on unsolved problems in early diagnosis, monitoring of the course of a disease and the patient's response to treatment. These are areas where there are extensive clinical benefits for patients and the healthcare system, current solutions are lacking or insufficient, and where IMMray™ has significant competitive advantages.

Initially, the key focus for Immunovia is to bring IMMray™ PanCan-d to the market. Because early detection of pancreatic cancer constitutes a major clinical problem, Immunovia considers there to be good prospects for being the first to establish a strong position on the market.

Organization. no. 556730-4299

EARLY DETECTION

Immunovia has its head office in Lund. Sweden Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm's main list (Mid Cap). For more information, please go to: www.immunovia.com

IMMray™ PanCan-d, could become the first blood-based test for early diagnosis of pancreatic cancer.

Early detection would increase the five-year survival rate by around 50%

Scheelevägen 8, Medicon Village 223 63 Lund, Sweden Phone: +46 (0)46-2756 000 [email protected] www.immunovia.com

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