Quarterly Report • Oct 28, 2021
Quarterly Report
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Report on the third quarter 2021
other adoptive T cell-based cancer therapies.
» Chief Executive Officer, Erik Manting, presented at the Pareto Securities' 12th Annual Healthcare Conference, September 1-2.
» Immunicum received a positive recommendation by the Data Safety and Monitoring Board (DSMB) for the use of ilixadencel in combination with an immune checkpoint inhibitor, pembrolizumab, based on the ongoing Phase Ib part of the ILIAD clinical study in multiple solid tumor indications.
» Immunicum announced a new research collaboration with the University Medical Center Groningen (UMCG), to explore novel treatment options for ovarian cancer based on the combination of Immunicum's cell-based cancer vaccine platform with immune checkpoint inhibitors (CPI). The project is supported by a grant from Health~Holland, Top Sector Life Sciences & Health (LSH).
» Immunicum has taken action to minimize the effect of the Covid-19 situation on operations.
| 2021 | 2020 | 2021 | 2020 | 2020 | |
|---|---|---|---|---|---|
| KSEK unless otherwise stated | jul-sep | jul-sep | jan-sep | jan-sep | Helår |
| Operating profit/loss | -26,297 | -15,524 | -98,354 | -39,382 | -86,027 |
| Net profit/loss | -26,866 | -15,960 | -100,567 | -41,368 | -89,248 |
| Earnings/loss per share, | |||||
| before and after dilution (SEK) | -0,13 | -0,22 | -0,56 | -0,56 | -1,17 |
| Cash | 181,504 | 13,620 | 181,504 | 13,620 | 167,643 |
| Shareholders equity | 688,986 | -10,148 | 688,986 | -10,148 | 661,094 |
| Number of employees | 29 | 20 | 29 | 20 | 29 |
* On December 21, 2020, Immunicum AB acquired DCPrime BV. The transaction resulted in the owners of the acquired company ( DCPrime) having deemed control of the acquiring company (Immunicum). The acquisition is therefore accounted for as a reverse acquisition. The consolidated financial statements, for prior period, thus only consist of DCPrime BV until the time of acquisition, December 21, 2020. This means that the result for full year 2020 refers to DCPrime BV's result for the entire financial year and Immunicum AB's result for the last 10 days of 2020. The result for 2021 refers to the consolidated group.
In the third quarter of 2021, Immunicum has made significant progress in its pipeline development. The independent Data Safety Monitoring Board for the ongoing ILIAD study confirmed the safety of Immunicum's intratumoral immune primer ilixadencel in combination with the leading immune checkpoint inhibitor pembrolizumab. Further data from the ILIAD study are expected in the fourth quarter, 2021.
Immunicum is preparing to present an update on the fully enrolled AD-VANCE II study at the American Society for Hematology meeting (ASH), to be held in December 2021. In the ADVANCE II study, DCP-001 relapse vaccination is being investigated as a prospective monotherapy in the treatment of acute myeloid leukemia (AML) patients with measurable residual disease (MRD) often associated with a high relapse rate. Following DCP-001 vaccination, the MRD status, progression-free status and overall survival are monitored, combined with immunomonitoring data, to assess whether the vaccination leads to improved immune control over residual disease. If successful, the study will pave the way for DCP-001 as a potential new maintenance therapy in AML.
Based on preclinical work presented at different conferences, including recently at the European Society for Gynecological Oncology (ESGO) meeting, we have initiated the Phase I ALISON study, a relapse vaccination study in ovarian cancer. The ALISON study is being carried out in collaboration with renowned Prof. Hans Nijman and his colleagues at the University Medical Centre Groningen (UMCG), The Netherlands. The joint expertise between Immunicum and UMCG has also resulted in a research collaboration focusing on potential synergies between relapse vaccination and checkpoint inhibitors in ovarian cancer. This collaboration, announced in the third quarter of 2021, is supported by a grant from Health~Holland. While we are collecting and evaluating data from these
clinical studies, we are also preparing for the next phase of our therapeutic and vaccine pipeline development with the help of world-leading clinical experts. Immunicum anticipates providing an update on the clinical trial strategy and outlook in the first quarter of 2022, following the receipt of additional data from the ILIAD and ADVANCE II studies.
Immunicum continues to invest in process development for both of its lead programs -DCP-001 and ilixadencel, which are off-the-shelf products based on our leading expertise in allogeneic dendritic cell biology. An advantage of allogeneic products is the prospect of overcoming the high variability and complex logistics associated with autologous cell-based therapies derived from patient material. By building out our process development know-how and skills, Immunicum is in a better position to develop robust and scalable manufacturing processes required for larger clinical studies and commercialization.
» While we are collecting and evaluating data of the clinical studies, we are preparing for the next phase of clinical pipeline development with the help of world-leading clinical experts«
»There are a vast number of opportunities Ilixadencel is a product derived from healthy donors, which makes it dependent on the logistics of collecting material from individual donors and subject to the intrinsic variability associated with it. Our ilixadencel process development efforts therefore focus on reducing product variability and establishment of comparability criteria.
In contrast, DCP-001 is derived from a cell line, with the advantage of having
unconditional access to the same starting material for each production batch. For continued DCP-001 process development, we are primarily focusing on increasing cell densities and improving scalability. Because this development work is carried out in-house, as opposed to through third parties, we can realize cost efficiencies, gain additional control over our products and capture more value for our shareholders.
Another key aspect of developing allogeneic cell-based products is the understanding of their mode of action. Immunicum has built up leading expertise in its own labs and through a global research network with academic partners. These ongoing research programs support our
pipeline development, by providing for additional data on our lead product candidates and providing the basis for potential new clinical programs. Our research network also continues to strengthen Immunicum's scientific leadership in the field of allogeneic dendritic cell biology, as exemplified by regular presentations of our data at scientific conferences, including the upcoming Society for the Immunotherapy of Cancer (SITC) conference in November.
Immunicum is committed to executing its strategy to address hard-to-treat solid tumors and the prevention of tumor recurrence. The ADVANCE II study update anticipated in December 2021 represents an important milestone in the positioning of DCP-001 as a potential novel maintenance therapy in AML. Based on these results, and further evaluation of the ilixadencel data including the Phase Ib ILIAD study, we will be in a position to provide an outlook of our clinical pipeline in early 2022. In the meantime, we have moved to a new location in Stockholm, Sweden and are preparing to move our R&D activities to new facilities in Leiden.
I would like to thank our employees, investigators, patients and shareholders for their continued support.
Chief Executive Officer
Immunicum's objective is to become an international, fully integrated biopharmaceutical company in the field of cancer immunotherapy, with scientific leadership in the field of allogeneic dendritic cell biology.
Immunicum aims to improve survival outcomes and quality of life for a broad population of cancer patients by focusing on two main challenges, being hard-to-treat established tumors and the prevention of tumor recurrence, with products that combine clinical efficacy with a benign safety profile.
Immunicum is developing off-the-shelf, cell-based products that are highly immunogenic based on underlying allogeneic dendritic cell biology and which have the potential to activate the patient's own immune system against cancer. The Company's lead programs, ilixadencel and DCP-001, are derived from healthy donor material and from Immunicum's proprietary DCOne® cell line, respectively. Immunicum is developing ilixadencel to address the tumor burden of established tumors via intratumoral immune priming and DCP-001 as a cancer relapse vaccine, aimed at the reduction of tumor recurrence following initial treatment.
The Company has been evaluating ilixadencel in combination with existing cancer therapies in several difficult-to-treat solid tumor indications, including renal cell cancer, hepatocellular cancer and gastrointestinal stromal tumors, Ilixadencel, which consists of proinflammatory allogeneic dendritic cells sourced from healthy donors, is injected into the tumor of a cancer patient to create an inflammatory environment and ultimately a specific immune response against that tumor. In an analysis of the Company's ongoing Phase Ib part of the ILIAD trial by an independent DSMB, ilixadencel was determined to be safe in combination with the immune checkpoint inhibitor pembrolizumab, thereby underscoring its potential as a safe and feasible combination therapy. Immunicum expects additional results of the Phase Ib part in Q4.
DCP-001 relapse vaccination is currently being studied in acute myeloid leukemia and ovarian cancer as a potential therapy to reduce tumor recurrence. DCP-001 is an intradermal vaccine derived from the Company's proprietary DCOne® leukemic cell line. During manufacturing, DCOne cells are shifted towards a mature dendritic cell phenotype, which results in cells that are highly immunogenic and expressing a multitude of tumor antigens, providing the basis for an attractive cancer vaccine candidate for a number of blood-borne and solid tumor indications. In addition to the ongoing Phase II ADVANCE II study in
AML, Immunicum initiated in Q2 with a feasibility study to examine DCP-001 as a relapse vaccine in ovarian cancer. Promising clinical data with DCP-001 has been presented at various conferences, including CIMT and EHA, and demonstrated its ability to induce immune responses to a broad range of tumor associated antigens in AML patients; preclinical results have shown that combining DCP-001 with established AML treatment regimens produced enhanced efficacy.
Building upon strong in-house research capabilities, Immunicum has expanded its network of scientific and corporate collaborations to further validate our leading position in the field. This includes the existing partnerships with PCI Biotech and Glycotope, as well as multiple academic collaborations.
The focus of the Company is to advance its clinical pipeline with the aim to provide improved cancer therapy options for patients and build long-term shareholder value. Immunicum aims to leverage its expertise in allogeneic dendritic cell biology through continued R&D and corpo-
rate development, including the expansion of its facilities in Leiden.
Immunicum has its corporate headquarters in Stockholm and is publicly traded under ticker symbol IMMU on the Nasdaq Stockholm Main Market.
in the third quarter of 2021. For DCP-001, top-line results
| Product & Indication | Combination | Preclinical | Phase I | Phase II | Phase III |
|---|---|---|---|---|---|
| Ilixadencel: an off-the-shelf cell-based immune primer for solid tumors | |||||
| Kidney cancer | Kinase inhibitors | MERECA study | RMAT | ||
| Liver cancer | Kinase inhibitors | Orphan Drug Designation | |||
| Sarcoma (including GIST) | Kinase inhibitors | Fast Track & Orphan Drug Designation | |||
| Multiple solid tumors | Checkpoint inhibitors | ILIAD study | |||
| DCP-001: an off-the-shelf cell-based relapse vaccine for solid and blood-borne tumors | |||||
| Acute myeloid leukemia | Monotherapy | ADVANCE-II study | Orphan Drug Designation | ||
| Ovarian cancer | Monotherapy | ALISON study | |||
| Preclinical pipeline: combination approaches, next-generation immune primers, novel immunotherapy concepts | |||||
| Undisclosed | Undisclosed |
The Group
The acquisition of DCPrime BV is accounted for as a reverse acquisition. This means that Immunicum AB is the legal Parent Company but is for accounting purposes treated as the acquired Company. DCPrime BV is the legal subsidiary but is treated as the acquiring Company for accounting purposes. The consolidated financial statements thus only consist of DCPrime BV until the time of acquisition, December 21, 2020. This means that the result for 2020 refers to DCPrime BV's result for the entire financial year and Immunicum AB's result for the last 10 days of 2020. The result for 2021 refers to the consolidated group.
No revenue was reported for the third quarter - (-). Other operating income amounted to KSEK -245 (-) for the third quarter and to KSEK 32 (-) for the first nine months of the year and consisted of exchange rate gains on accounts payable.
Total operating expenses for the third quarter amounted to KSEK 26,051 (15,524) and to KSEK 98,386 (39,382) for the first nine months of the year. The operating expenses are primarily due to research and development expenses related to the DCOne® platform and the product candidates DCP-001 and ilixadencel, as well as administration expenses. The increased costs during the third quarter, compared with last year, are mainly due to accounting-related principles with respect to the reverse acquisition.
Research and development costs for the third quarter amounted to KSEK 14,508 (11,643) and to KSEK 65,636 (30,357) for the first nine months of the year. The costs are mainly related to preclinical and process development activities,and the ILIAD, ADVANCE II and ALISON clinical trials. The increased costs during the third quarter, compared with last year, are mainly due to accounting-related principles with respect to the reverse acquisition.
Administrative expenses for the third quarter amounted to KSEK 11,429 (3,862) and to KSEK 32,118 (9,104) for the first nine months of the year. The increased costs for the quarter and for the first nine months of the year compared with last year, are mainly due to accounting-related principles with respect to the reversed acquisition.
Operating result for the quarter was KSEK -26,297 (-15,524). The result for the first nine months of the year amounted to KSEK –98,354(-39,382). Earnings per share before and after dilution amounted to SEK -0.13 (-0.22) for the quarter and to SEK -0.56 (-0.56) for the first nine months of the year.
No tax was reported for the quarter and< for the first nine monts - (-).
Cash flow from operating activities for the third quarter amounted to KSEK -25,358 (-14,891) and to KSEK -96,820 (-38,115) for the first nine months of the year. The negative cash flow is according to development plan and is mainly explained by the Company's research and development activities for the DCOne® platform, the product candidates DCP-001 and ilixadencel. The increased negative cashflow during the third quarter 2021 compared to 2020 is due to accounting-related principles with respect to the reverse acquisition.
During the third quarter cash flow from investing activities amounted to KSEK -36 (-0) and to KSEK -1,316 (-454) for the first nine months of the year. Cash flow from financing activities for the third quarter amounted to KSEK -1,050 (-472) and to KSEK 127,537 (41,957) for the first nine months of the year.
The Company's cash and cash equivalents on September 30, 2021 amounted to KSEK 181,504 (13,620).
Total equity as of September 30, 2021 amounted to KSEK 688,986 (-10,148), which corresponds to SEK 3.46 (-0.14) per share. The Company's equity ratio at the end of the quarter was 93% (-28%).
* On December 21, 2020, Immunicum AB acquired DCPrime BV. The transaction resulted in the owners of the acquired company ( DCPrime) having deemed control of the acquiring company (Immunicum). The acquisition is therefore accounted for as a reverse acquisition. The consolidated financial statements, for the prior period, thus only consist of DCPrime BV until the time of acquisition, December 21, 2020. This means that the result for full year 2020 refers to DCPrime BV's result for the entire financial year and Immunicum AB's result for the last 10 days of 2020. The result for 2021 refers to the consolidated group.
No revenue was reported for the third quarter nor the first nine months of the year - (-). Other operating income amounted to KSEK 1,898 (885) for the third quarter and KSEK 2,174 (2,099) for the first nine months of the year and consisted of exchange rate gains on accounts payable and invoicing of management fee to DCPrime BV.
Total operating expenses for the first quarter amounted to KSEK 14,096 (22,535) and to KSEK 53,825 (82,770) for the first nine months of the year. The operating expenses are primarily due to administrative expenses and clinical trials. The lower costs during the third quarter, compared with last year, is mainly due to lower CMC costs.
Research and development costs for the second quarter amounted to KSEK 4,645 (16,554) and to KSEK 28,692 (57,700) for the first nine months of the year. The costs are mainly due to activities in ongoing clinical studies. The lower costs for the third quarter, compared to last year, are primarily due to lower CMC expenses.
Administrative expenses for the third quarter amounted to KSEK 9,372 (5,504) and to 24,551 (23,353) for the first nine months of the year. Included costs among administration (G&A) are mainly attributable to the finance department, executive management, investor relations and business development.
Operating result for the third quarter was KSEK -12,198 (-21,650) and for the first nine months of the year KSEK -51,651 (-80,671). The result for the third quarter amounted to KSEK -11,966 (-22,244) and to KSEK -51,421 (-80,368) for the first nine months of the year. Earnings per share before and after dilution for the Parent Company amounted to SEK -0.06 (-0.24) for the third quarter and to SEK -0.29 (-0.87) for the first nine months of the year.
No tax was reported for the third quarter or the first nine month of the year - (-).
Cash flow from operating activities for the quarter amounted to KSEK -14,305 (-33,980) and to KSEK-60 523 (-99 503) for the frist nine month period . The negative cash flow is according to development plan and administrative expenses.
During the third quarter cash flow from investing activities amounted to KSEK - 20,432 (-) and to KSEK -50,975 (-) for the first nine months of the year. The cash flow during the first nine months of the year is related to a shareholders' contribution to DCprime. The cash flow from financing activities amounted to KSEK -191 (-0) for the third quarter and to KSEK 128,951 (-11) for the first nine months of the year.
The Company's cash and cash equivalents on September 30, 2021 amounted to KSEK 175,471 (197,602).
Total equity as of September 30, 2021 amounted to KSEK 803,653 (192,404), which corresponds to SEK 4.03 (2.09) per share. The Company's equity ratio at the end of the quarter was 99% (94%).
The purpose of share-based incentive programs is to promote the Company's long-term interests by motivating and rewarding the Company's senior management and other employees in line with the interest of the sharehold¬ers. There are currently two outstanding incentive programs in the Company. In accordance with a decision by the Annual General Meeting in April 2019, a share-based incen¬tive program; "LTI 2019/2022" was introduced. For further information about this program, see the minutes of the Annual General Meeting 2019 published on the Company's website, www.immunicum.com.
In conjunction with that a couple of key employees left their employment, Immunicum has exercised its right to repurchase 538,168 subscription options from the em¬ployees that left the Company. Of those 538,168 options, 368,812 options have been cancelled and 169,356 options have been acquired by an employee according to decisions approved at the Annual General Meeting in April 2020.
Full utilization of granted options corresponding to 1,809,277 shares will result in a dilution for shareholders of 0.9 percent. Each warrant entitles the holder to subscribe for one (1) share in the Company during the period commenc¬ing on May 28, 2022 up to and including July 28, 2022.
In accordance with a decision by the Annual General Meeting in May 2021, a share-based incen¬tive program; "LTI 2021/2024" was introduced. For further information about this program, see the minutes of the Annual General Meeting 2021 published on the Company's website, www. immunicum.com.
In total 1,286,092 options and 660,000 restricted shares has been granted, which correspondences to a dilution of 0,97% if full utilization will be
As of September 30, 2021, the Group had 29 (20) fulltime employ¬ees, of whom 17 (12) were women and 12 (8) were men.
The share is traded on Nasdaq Stockholm Main Market under the ticker symbol IMMU, with the ISIN code SE0005003654. The number of shares in the Company as of September 30, 2021 amounted to 199,400,599 (73,909,635) and the share capital in the Company amounted to KSEK 9,923 (578). All shares have equal voting right and share of Immunicum's assets and profit.
| Source: Euroclear Sweden AB. Owners |
Shares | Capital Votes |
|---|---|---|
| Adrianus Van Herk | 86,465,754 | 43,36% |
| Fourth Swedish National Pension Fund 19,575,980 | 9,82% | |
| Avanza Pension | 8,734,924 | 4,38% |
| Nordnet Pension | 6,782,001 | 3,40% |
| Loggen Invest AB | 3,100,000 | 1,55% |
| Holger Blomstrand Byggnads AB | 2,975,386 | 1,49% |
| Erik Manting | 1,064,824 | 0,53% |
| Handelsbanken Fonder | 1,059,693 | 0,53% |
| Swedbank Försäkring | 922,876 | 0,46% |
| Elivågor AB | 875,000 | 0,44% |
| Ivar Nordqvist | 830,256 | 0,42% |
| SEB Funds | 732,449 | 0,37% |
| SEB Trygg Liv | 667,923 | 0,33% |
| Alex Karlsson-Parra | 621,736 | 0,31% |
| Hans Edvin Ståhlgren | 600,000 | 0,30% |
| FCG Funds | 574,024 | 0,29% |
| Bengt Andersson | 571,319 | 0,29% |
| Futur Pension | 561,065 | 0,28% |
| Pinje Fastighet AB | 549,986 | 0,28% |
| Jeroen Rovers | 534,000 | 0,27% |
| Other | 61 601,403 | 30,89% |
| Total | 199 400 599 | 100.00% |
Stockholm October 27, 2021 Immunicum AB (publ)
Erik Manting CEO
This is a translation from the Swedish original
We have reviewed the condensed interim report for Immunicum AB (publ) as at September 30, 2021 and for the nine months period then ended. The Board of Directors and the Managing Director are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
We conducted our review in accordance with the International Standard on Review Engagements, ISRE 2410 Review of Interim Financial Statements Performed by the Independent Auditor of the Entity. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing and other generally accepted auditing standards in Sweden. The procedures
performed in a review do not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act regarding the Group, and in accordance with the Swedish Annual Accounts Act regarding the Parent Company.
Stockholm, October 28, 2021 Ernst & Young AB
Charlotte Holmstrand Authorized Public Accountant
| 2021 | 2020 | 2021 | 2020 | 2020 | |
|---|---|---|---|---|---|
| Amounts in KSEK | jul-sep | jul-sep | jan-sep | jan-sep | jan-dec |
| Other operating income | -245 | – | 32 | – | – |
| -245 | – | 32 | – | – | |
| OPERATING EXPENCES | |||||
| Administration expenses | -11,429 | -3,862 | -32,118 | -9,104 | -38,080 |
| Research and development expenses | -14,508 | -11,643 | -65,636 | -30,257 | -47,883 |
| Other operating expenses | -114 | -19 | -633 | -21 | -65 |
| Operating profit/loss | -26,297 | -15,524 | -98,354 | -39,382 | -86,027 |
| RESULT FROM FINANCIAL ITEMS | |||||
| Financial income | – | – | – | – | – |
| Financial costs | -569 | -436 | -2,213 | -1,986 | -3,220 |
| Profit/loss after financial items | -26,866 | -15,960 | -100,567 | -41,368 | -89,248 |
| TOTAL PROFIT/LOSS BEFORE TAXES | -26,866 | -15,960 | -100,567 | -41,368 | -89,248 |
| Income tax expense | – | – | – | – | – |
| PROFIT/LOSS FOR THE PERIOD | -26,866 | -15,960 | -100,567 | -41,368 | -89,248 |
| Earnings/loss per share before and after dilution (SEK), for profit attributable to |
|||||
| owner of the parent company's shareholders. | -0,13 | -0,22 | -0,56 | -0,56 | -1,17 |
| Amounts in KSEK | 2021 jul-sep |
2020 jul-sep |
2021 jan-sep |
2020 jan-sep |
2020 jan-dec |
|---|---|---|---|---|---|
| Result for the period Other comprehensive income |
-26,866 | -15,960 | -100,567 | -41,368 | -89,248 |
| Exchange differences on translation of foreign operations |
-52 | -185 | -493 | -1,898 | 3,231 |
| Other comprehensive income for the period | -52 | -185 | -493 | -1,898 | 3,231 |
| Total comprehensive income for the period | -26,918 | -16,145 | -101,059 | -43,266 | -86,017 |
Profit/loss for the period and total comprehensive income, are in their entirety attributable to the parent company's shareholders.
| Amounts in KSEK | 30 sept 2021 | 30 sept 2020 | 31 dec 2020 |
|---|---|---|---|
| ASSETS | |||
| NON-CURRENT ASSETS | |||
| Goodwill | 108,350 | – | 108,350 |
| Technology | 424,091 | – | 424,091 |
| Right-of-use assets | 576 | 1,487 | 1,204 |
| Equipment | 2,322 | 1,991 | 1,705 |
| Other long term receivables | 700 | 447 | 677 |
| Total Non-current assets | 536,039 | 3,925 | 536,028 |
| CURRENT ASSETS | |||
| Other receivables | 17,479 | 18,275 | 20,230 |
| Prepaid expenses and accrued income | 9,636 | 265 | 4,760 |
| Cash and cash equivalents | 181,504 | 13,620 | 167,643 |
| Total current assets | 208,620 | 32,160 | 192,634 |
| TOTAL ASSETS | 744,659 | 36,085 | 728,661 |
| SHAREHOLDERS' EQUITY AND LIABILITIES SHAREHOLDERS' EQUITY Share capital Additional paid-in capital Reserves Retained earnings (including profit/loss for the period) |
9,970 1,130,334 3,039 -454,357 |
586 296,771 -3,309 -304,196 |
8,308 1,003,044 3,532 -353,790 |
| Total equity attributable to the shareholders of the parent company | 688,986 | -10,148 | 661,094 |
| LIABILITIES | |||
| NON-CURRENT LIABILITIES | |||
| Other long-term liabilities Lease liabilities |
36,079 – |
37,104 554 |
18,982 303 |
| Total non-current liabilities | 36,079 | 37,658 | 19,285 |
| CURRENT LIABILITIES | |||
| Lease liabilities | 536 | 913 | 880 |
| Accounts payable Other liabilities |
4,032 8,940 |
963 5,836 |
10,365 23,179 |
| Accrued expenses and deferred income | 6,085 | 864 | 13,857 |
| Total current liabilities | 19,593 | 8,576 | 48,282 |
| Total liabilities | 55,672 | 46,234 | 67,567 |
| TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES | 744,659 | 36,085 | 728,661 |
Attributable to owners of Immunicum AB (publ)
| Retained | |||||
|---|---|---|---|---|---|
| Additional | earnings inc. | ||||
| Share | paid in | profit/loss for | |||
| Amounts in KSEK | capital | capital | Reserves | the period | Total |
| Opening shareholders' equity 01/01/2021 | 8,308 | 1,003,044 | 3,532 | -353,789 | 661,096 |
| Profit/loss for the period | – | – | – | -100,567 | -100,567 |
| Other comprehensive income | – | – | -493 | – | -493 |
| Total comprehensive income | – | – | -493 | -100 567 | -101,059 |
| Transactions with owners | |||||
| Share issue | 1,662 | 139,581 | – | – | 141,242 |
| Costs for new share issue | – | -12,291 | – | – | -12,292 |
| Total transaction with owners | 1,662 | 127,290 | – | – | 128,950 |
| Shareholders' equity 30/09/2021 | 9,970 | 1,130,334 | 3,039 | -454,357 | 688,987 |
| Opening shareholders' equity 01/01/2020 | 586 | 257,980 | 301 | -264,541 | -5,674 |
| Profit/loss for the period | – | – | – | -41,368 | -41,368 |
| Other comprehensive income | – | – | -1,898 | – | -1,898 |
| Total comprehensive income | – | – | -1,898 | -41,368 | -43,266 |
| Transactions with owners | |||||
| Shareholders' contribution | – | 38,791 | -1,712 | -1,712 | 38,791 |
| Total transaction with owners | – | 38,791 | -1,712 | -1 712 | 38,791 |
| Shareholders' equity 30/09/2020 | 586 | 296,771 | -3,309 | -304,197 | -10,148 |
| Opening shareholders' equity 01/01/2020 | 586 | 257,980 | 301 | -264,541 | -5,674 |
| Profit/loss for the period | – | – | – | -89,248 | -89,248 |
| Other comprehensive income | – | – | 3,231 | – | 3,231 |
| Total comprehensive income | 586 | 257,980 | 3,532 | -353,789 | -91,691 |
| Transactions with owners | |||||
| New share issue | 5,452 | -5,452 | – | – | – |
| Issue for non-cash consideration | 3,695 | 697,462 | – | – | 701,157 |
| Shareholders' contribution | – | 53,681 | – | – | 53,681 |
| Redistribution as of reverse acquisition | -1,425 | 1,425 | – | – | – |
| Issue costs | – | -2,052 | – | – | -2,052 |
| Total transaction with owners | 7,722 | 745,064 | – | – | 752,786 |
| Shareholders' equity 31/12/2020 | 8,308 | 1,003,044 | 3,532 | -353,789 | 661,096 |
| Amounts in KSEK | 2021 | 2020 | 2021 | 2020 | 2020 |
|---|---|---|---|---|---|
| jul-sep | jul-sep | jan-sep | jan-sep | jan-dec | |
| Operating activities | |||||
| Operating profit/loss | -26,296 | -15,529 | -98,354 | -39,382 | -86,029 |
| Adjustment for items not included in cash flow | 711 | 689 | 1,374 | 1,345 | 1,774 |
| Interest expense paid | 226 | -51 | 160 | -78 | -103 |
| Cash flow from operating activities before | |||||
| changes in working capital | -25,358 | -14,891 | -96,820 | -38,115 | -84 358 |
| Increase/decrease in other current receivables | -2,741 | 231 | -1,769 | 776 | 22,204 |
| Increase/decrease in accounts payable | -4,792 | -940 | -6,507 | -955 | 761 |
| Increase/decrease in other current liabilities | 3,623 | 4,488 | -7,316 | -1,928 | 4,766 |
| Cash flow from operating activities | -29,271 | -11,112 | -112,414 | -40,222 | -56,626 |
| Investment activities | |||||
| Investments in tangible assets | -36 | – | -1,316 | -454 | -464 |
| Investment in financial fixed assets | – | – | – | – | – |
| Acquistion of business | – | – | – | – | 157,762 |
| Cash flow from investing activitiesn | -36 | – | -1,316 | -454 | 157,298 |
| Financing activities | |||||
| Shareholders contribution | – | – | – | 38,791 | 53,681 |
| New share issues | – | – | 141,242 | – | – |
| New share Issue costs | -191 | – | -12,291 | – | -2,052 |
| Proceeds from borrowings | – | -35 | – | 3,824 | 3,798 |
| Repayment of borrowings | -859 | -437 | -1 414 | -658 | -4,523 |
| Cash flow from financing activities | -1,050 | -472 | 127,537 | 41,957 | 50,904 |
| Cash and cash equivalents at the | |||||
| beginning of the period | 211,709 | 25,289 | 167,643 | 14,343 | 14,032 |
| Cash flow for the period | -30,358 | -11,585 | 13,807 | 1,281 | 151 576 |
| Foreign echange difference in | |||||
| cash and cash equivalents | 152 | -84 | 54 | -2,004 | 2,035 |
| Cash and cash equivalents at the | |||||
| end of the period | 181,504 | 13,620 | 181,504 | 13,620 | 167,643 |
| 2021 | 2020 | 2021 | 2020 | 2020 | |
|---|---|---|---|---|---|
| Amounts in KSEK | jul-sep | jul-sep | jan-sep | jan-sep | jan-dec |
| Other operating income | 1,898 | 885 | 2,174 | 2,099 | 2,444 |
| 1,898 | 885 | 2,174 | 2,099 | 2,444 | |
| OPERATING EXPENSES | |||||
| Sales, general and administration expenses | -9,372 | -5,504 | -24,551 | -23,353 | -27,726 |
| Research and development expenses | -4,645 | -16,554 | -28,692 | -57,700 | -79,191 |
| Other operating expenses | -79 | -477 | -582 | -1,717 | -2,148 |
| Operating profit/loss | -12,198 | -21,650 | -51,651 | -80,671 | -106,621 |
| Net financial items | 251 | 18 | 256 | 897 | 313 |
| Interest expense and similar items | -19 | -612 | –26 | -594 | – |
| Profit/loss after financial items | -11,966 | -22,244 | -51,421 | -80,368 | -106,308 |
| Income tax expense | – | – | – | – | – |
| PROFIT/LOSS FOR THE PERIOD | -11,966 | -22,244 | -51,421 | -80,368 | -106,308 |
| Earnings/loss per share | |||||
| before and after dilution (SEK) | -0,06 | -0,24 | -0,29 | -0,87 | -1,13 |
| Amounts in KSEK | 2021 | 2020 | 2021 | 2020 | 2020 |
|---|---|---|---|---|---|
| jul-sep | jul-sep | jan-sep | jan-sep | jan-dec | |
| Result for the period | -11,966 | -22,244 | -51,421 | -80,368 | -106,308 |
| Other comprehensive income | – | – | – | – | – |
| Total comprehensive result for the period | -11,966 | -22,244 | -51,421 | -80,368 | -106,308 |
| Amounts in KSEK | 2021-09-30 | 2020-09-30 | 2020-12-31 |
|---|---|---|---|
| ASSETS | |||
| Total tangible assets | |||
| Participants in Group companies | 608,853 | 1 | 578,311 |
| Other long term receivables | 20 683 | 252 | 252 |
| Total financial assets | 629,537 | 253 | 578,563 |
| Total fixed assets | 629,537 | 253 | 578,563 |
| CURRENT ASSETS | |||
| Other receivables | 142 | 1,787 | 3,333 |
| Prepaid expenses and accrued income | 9,562 | 4,553 | 4,509 |
| Total current receivables | 9,704 | 6,340 | 7,842 |
| Cash and bank balances | 175,471 | 197,603 | 157,762 |
| Total current assets | 185,175 | 203,943 | 165,604 |
| TOTAL ASSETS | 814,712 | 204,196 | 744,167 |
| SHAREHOLDERS' EQUITY AND LIABILITIES | |||
| SHAREHOLDERS' EQUITY | |||
| Share capitall | 9,970 | 4,613 | 8,308 |
| Total restricted equity | 9 970 | 4 613 | 8 308 |
| Share premium reserve | 1,415,073 | 731,818 | 1,287,784 |
| Retained earnings | -569,969 | -463,661 | -463,661 |
| Profit/loss for the period | -51,421 | -80,368 | -106,308 |
| Total unrestricted equity | 793,686 | 187,789 | 717,815 |
| Total shareholders' equity | 803,653 | 192,402 | 726,123 |
| LIABILITIES | |||
| LONG-TERM LIABILITIES | |||
| Other long-term liabilities | 850 | 850 | 850 |
| Total long-term liabilities | 850 | 850 | 850 |
| CURRENT LIABILITIES | |||
| Accounts payable | 1,641 | 4,867 | 7,811 |
| Other liabilities | 774 | 1,416 | 2,013 |
| Accrued expenses and deferred income | 7,794 | 4,660 | 7,369 |
| Total current liabilities | 10,209 | 10,943 | 17,193 |
| Total liabilities | 11,059 | 11,793 | 18,043 |
| TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES | 814,712 | 204,196 | 744,167 |
| Share | Retained earnings inc. |
|||
|---|---|---|---|---|
| Share | premium | profit/loss for | ||
| Amounts in KSEK | capital | reserve | the period | Totalt |
| Opening shareholders' equity 01/01/2021 | 8,308 | 1,287,784 | -569,969 | 726,123 |
| Profit/loss for the period | – | – | -51,422 | -51,422 |
| Comprehensive result for the period | – | – | -51 422 | -51 422 |
| Transactions with owners | ||||
| Share issue | 1,662 | 139,580 | – | 141,242 |
| Costs for new share issue | – | -12,291 | – | -12,291 |
| Total transaction with owners | 1,662 | 127,289 | – | 128,951 |
| Shareholders' equity 30/09/2021 | 9,970 | 1,415,073 | -621,391 | 803,652 |
| Opening shareholders' equity 01/01/2020 | 4,613 | 731,828 | -463,661 | 272,780 |
| Profit/loss for the period | – | – | -80,368 | -80,368 |
| Comprehensive result for the period | – | – | -80,368 | -80,368 |
| Transactions with owners | ||||
| Premiums for warrants | – | -11 | – | -11 |
| Total transaction with owners | – | -11 | – | -11 |
| Shareholders' equity 30/09/2021 | 4,613 | 731,817 | -544,029 | 192,401 |
| Opening shareholders' equity 1/1/2020 | 4,613 | 731,828 | -463,661 | 272,781 |
| Profit/loss for the period | – | – | 106,308 | -106,308 |
| Comprehensive result for the period | – | – | -106 308 | -106 308 |
| Transactions with owners | ||||
| Premiums for repurchased warrants | – | -187 | – | -187 |
| Premiums for sold warrants | – | 176 | – | 176 |
| Direct share issue, contribution in kind | 3,695 | 555,966 | – | 559,661 |
| Total transaction with owners | 3,695 | 555,955 | – | 559,650 |
| Shareholders' equity 31/12/2020 | 8,308 | 1,287,784 | -569,969 | 726,123 |
| 2021 | 2020 | 2021 | 2020 | 2020 | |
|---|---|---|---|---|---|
| Amounts in KSEK | jul-sep | jul-sep | jan-sep | jan-sep | jan-dec |
| Operating activities | |||||
| Operating profit/loss before financial items | -12,198 | -21,650 | -51,651 | -80,671 | -106,621 |
| Adjustment for items not included in cash flow | – | – | – | – | – |
| Interest income received | – | – | – | – | 15 |
| Interest expense paid | -19 | – | -26 | -2 | -2 |
| Increase/decrease in other current receivables | -2,292 | 3,362 | -1 862 | 426 | -1,076 |
| Increase/decrease in accounts payable | -4,054 | -15,691 | -6,170 | -7,952 | -5,008 |
| Increase/decrease in other current liabilities | 4,258 | 1 | -814 | -11,304 | -7,998 |
| Cash flow from operating activities | -14,305 | -33,980 | -60,523 | -99,503 | -120,690 |
| Investment activities | |||||
| Increase/decrease in long term receivable, intra-group | -20,432 | – | -20 432 | – | – |
| Investment in financial assets | – | – | -30,543 | – | -16,597 |
| Cash flow from investing activities | -20,432 | – | -50,975 | – | -16,597 |
| Financing activities | |||||
| New share issues | – | – | 141,242 | – | -2,052 |
| New share Issue costs | -191 | – | -12,291 | – | – |
| Premiums for repurchased warrants | – | – | – | -187 | -187 |
| Premiums for sold warrant | – | – | – | 176 | 176 |
| Cash flow from financing activities | -191 | – | 128,951 | -11 | -2,063 |
| Cash and cash equivalents at the | |||||
| beginning of the period | 210,148 | 232,176 | 157,762 | 296,811 | 296,811 |
| Cash flow for the period | -34,928 | -33,980 | 17,453 | -99,514 | -139,350 |
| Foreign echange difference in cash | |||||
| and cash equivalents | 251 | -594 | 256 | 305 | 300 |
| Cash and cash equivalents at | |||||
| the end of the period | 175,471 | 197,602 | 175,471 | 197,602 | 157,762 |
This report covers the Swedish company Immunicum AB (publ) (Immunicum), Swedish corporate identity no. 556629-1786. The Company is a Swedish public limited company registered in Stockholm and with its registered office in Stockholm. The quarterly report was authorized for issue by the Board of Directors on October 27, 2021.
This note provides a list of the significant accounting policies adopted in the preparation of these consolidated financial statements. These policies have been consistently applied to all the years presented.
The consolidated financial statements for Immunicum have been prepared in accordance with the Swedish Annual Accounts Act, Swedish Financial Reporting Board's recommendation RFR 1 Supplementary rules for groups, lnternational Financial Reporting Standards (IFRS) and Interpretations issued by the IFRS Interpretations Committee (IFRS IC) as endorsed by the EU.
The financial statements have been prepared on a historical cost basis.
The interim report has been prepared in accordance with IAS 34 Interim financial reporting and Swedish Annual Accounts Act.
The interim report for the Parent Company is prepared in accordance with the Swedish Annual Accounts Act and RFR 2 Financial reports for legal entities.
In cases where the parent company applies other accounting principles than the Group's accounting principles. These are stated in the Annual report 2020 (note 2, page 55-59).
The accounting principles for the consolidated financial report remains unchanged andis described in the Annual Report (note 2 page 55-59)
judgements for accounting purposes
The preparation of financial statements requires the use of accounting estimates which will seldom equal the actual results. Management also needs to exercise judgement in applying the Group's accounting policies. These assessments are unchanged and appear from the annual report for 2020 (note 5, page 60).
The Covid-19 pandemic is evolving rapidly and is having a significant impact on the global healthcare system. Many hospitals, regions and countries are updating their guidelines and Immunicum is following the developments closely ready to take necessary steps to fully comply with the new guidance as required. Immunicum has also taken necessary actions to ensure the well-being, safety and security of the Company's employees. At reporting date, the ongoing studies continues as planned. For the Phase II MERECA and Phase Ib/II ILIAD trials, patients have been enrolled and are being followed as to survival. Phase II ADVANCE is aswell fully enrolled. There is however still a risk that Covid-19 results in a delay or gap in the clinical study data collection and/or processing by the CRO. For the Phase I/II ALISON trials, recruitment is ongoing and there is a risk that recruitment is further delayed due to the pressure of Covid-19 on the involved clinical centers.
Immunicum's team is working closely with the clinical centers involved to make sure timelines and quality are secured and mitigation steps are in place.
Sufficient stock of ilixadencel and DCP-001 is in place to complete the ongoing studies and potential new studies in the near term. Regulatory authority interactions are considered unlikely to be affected. There is a general risk associated with the impact the Covid-19 pandemic might have on the capital markets. If extended in time it could adversely affect the Company's access to the capital markets, which could have a negative impact on the Company's business.
Immunicum is a research and development Company that still is in its early stages. The Company has not generated any revenues historically and is not expected to do so in the short term. The Company's candidates for cancer immune primers and technology platforms are dependent on research and development and may be delayed and/ or incur greater costs. The Company is dependent upon its ability to enter into licensing agreements and joint collaboration agreements, as well as dependent on a large number of approvals and remuneration systems and the related laws, regulations, decisions and practices (which may change). In addition, the Company is also dependent upon intellectual property rights. The risk that is determined to have particular importance for future development of Immunicum is access to financial funds.
This report includes forward looking statements. Actual
outcomes may deviate from what has been stated. Internal factors such as successful management of research projects, and intellectual property rights may affect future results. There are also external conditions, e.g. the economic climate, political changes and competing research projects that may affect Immunicum's results. For a more detailed description of significant risk factors, please see the 2020 Annual Report available on the Company's website www.immunicum.com.
Sven Rohmann, former CEO of Immunicum AB, has during the nine month period year invoiced the Company KSEK 2,785 in consultancy fees through the Company Suenos Advisors Establishment. Margareth Jorvid, former Head of Regulatory Affairs & Quality System and former member of Immunicum's management team, has during the nine month period invoiced Immunicum KSEK 754 in consultancy fees through the Company Methra Uppsala AB. Peter Suenaert, former CMO and member of Immunicum's management team, has during the nine month
period invoiced Immunicum KSEK 1,633 in consultancy fees through the Company Sparkclin BV.
Immunicum's financial assets and liabilities comprise of cash and cash equivalents, other current assets, other securities held as fixed assets, other long-term receivables, other long-term liabilities, other liabilities and accounts payable. The fair value of all financial instruments is materially equal to their carrying amounts.
No events after end of period
Participations in Group companies refer to participations in DCPrime BV which were acquired on December 21, 2020. Immunicum holds 100% of the share of the capital and of the voting power. The number of shares amounts to 60,000,000 shares.
The Company presents in this report certain key performance measures, including two measures that is not defined under IFRS, namely expenses relating to research and development/operating expenses % and equity ratio. These financial performance measures should not be viewed in isolation or be considered to replace the performance indicators that have been prepared in accordance with IFRS. In addition, such performance measure as the Company has defined it should not be compared with other performance measures with similar names used by other companies. This is because the above-mentioned performance measure is not always defined in the same manner, and other companies may calculate them differently to Immunicum.
| 2021 juli-sept |
2020 juli-sept |
2021 jan-sep |
2020 jan-sep |
2020 jan-dec |
|
|---|---|---|---|---|---|
| Share capital at end of period, SEK | 9,970 | 586 | 9,970 | 586 | 8,308 |
| Equity at the end of period, KSEK | 688 986 | -10,148 | 688,986 | -10,148 | 661,094 |
| Earnings per share before and after dilution, SEK | -0,13 | -0,22 | -0,56 | -0,56 | -1,17 |
| Research and development costs, KSEK | -14,508 | -11 643 | -65 636 | -30,257 | -47,883 |
| Research and development costs/operating expenses, % | 56% | 75% | 67% | 77% | 56% |
| 2021 juli-sept |
2020 juli-sept |
2021 jan-sep |
2020 jan-sep |
2020 jan-dec |
|
|---|---|---|---|---|---|
| Total registered shares at the beginning of period | 199,400,599 | 92,257,531 | 166,167,166 | 92,257,531 | 92,257,531 |
| Total registered shares at the end of period | 199,400,599 | 92,257,531 | 199,400,599 | 92,257,531 | 166,167,166 |
| Share capital at the end of period, SEK | 9,970 | 4,613 | 9,970 | 4,613 | 8,308 |
| Equity at the end of period, SEK thousand | 803,653 | 192,402 | 803,653 | 192,402 | 726,123 |
| Earnings per share before and after dilution, SEK | -0.06 | 0.24 | -0.29 | -0.87 | -1.13 |
| Research and development costs, SEK thousand | -4,645 | -16,554 | -28,692 | -57,700 | -79,191 |
| Research & development costs/operating expenses % | 33% | 73% | 53% | 70% | 73% |
| Alternative performance | |||||
|---|---|---|---|---|---|
| measurementsments | Definition | Justification | |||
| Equity ratio | Total shareholders' equity divided by total assets |
The key ratio provides useful information of the Company's capital structure. |
|||
| Research & development costs/operating expenses, % |
Research & development costs/operating expenses, % |
The research and development /operating expenses ratio is an important complement because it allows for a better evaluation of the Company's economic trends and the proportion of its costs that are attributable to the Company's core business. |
| 2021 jul-sep |
2020 jul-sep |
2021 jan-sep |
2020 jan-sep |
2020 jan-dec |
|
|---|---|---|---|---|---|
| Equity ratio at the end of the period % | |||||
| Total shareholders equity at the end of the period, KSEK | 688 986 | -10 148 | 688 986 | -10 148 | 661 094 |
| Total assest at the end of the period, KSEK | 744 659 | 36 085 | 744 659 | 36 085 | 728 661 |
| Equity ratio at the end of the period, % | 93% | -28% | 93% | -28% | 91% |
| Research & Development costs/operating expenses, % | |||||
| Research & Development costs | -14 508 | -11 643 | -65 636 | -30 257 | -47 883 |
| Administrative costs | -11 429 | -3 862 | -32 118 | -9 104 | -38 080 |
| Other operating expenses | -114 | -19 | -633 | -21 | -65 |
| Total operating expenses | -26 051 | -15 524 | -98 386 | -39 382 | -86 027 |
| Research & development costs/operating expenses, % | 56% | 75% | 67% | 77% | 56% |
| 2021 | 2020 | 2021 | 2020 | 2020 | |
|---|---|---|---|---|---|
| jul-sep | jul-sep | jan-sep | jan-sep | jan-dec | |
| Equity ratio at the end of the period % | |||||
| Total shareholders equity at the end of the period, KSEK | 803 653 | 192 402 | 803 653 | 192 402 | 726 123 |
| Total assest at the end of the period, KSEK | 812 570 | 204 196 | 812 570 | 204 196 | 744 167 |
| Equity ratio at the end of the period, % | 99% | 94% | 99% | 94% | 98% |
| Research & Development costs/operating expenses, % | |||||
| Research & Development costs | -4 645 | -16 554 | -28 692 | -57 700 | -79 191 |
| Administrative costs | -9 372 | -5 504 | -24 551 | -23 353 | -27 726 |
| Other operating expenses | -79 | -477 | -582 | -1 717 | -2 148 |
| Total operating expenses | -14 096 | -22 535 | -53 825 | -82 770 | -109 065 |
| Research & development costs/operating expenses, % | 33% | 73% | 53% | 70% | 73% |
Year-end report 2021 17 februari 2022 Annual General Meeting 2022 10 may 2020
Erik Manting, CEO, Immunicum Phone: +46 (0)8 732 8400 E-mail: [email protected]
Telephone: +46 (0)8 732 8400 E-mail: [email protected]
Postal address: Västra Trädgårdsgatan 15 SE- 111 53 Stockholm, Sweden Website: www.immunicum.com Corporate identity number: 556629-1786
The information contained in this report is that which Immunicum (publ), is obliged to publish in accordance with the Swedish Securities Market Act (SFS 2007:528). The information was submitted for publication, through the agency of the contact persons set out above, on October 28, 2021, at 08:00 a.m. CET.
The Group is referred to unless otherwise stated in this Year-end report. Figures in parentheses refer to the corresponding period last year.
This report has been prepared in a Swedish original version and translated into English. In the event of any inconsistency between the two versions, the Swedish language version should have precedence.
Immunicum AB Västra Trädgårdsgatan 15 SE-111 53 Stockholm, Sweden Phone: +46 (0)8 732 8400
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