Quarterly Report • Aug 26, 2021
Quarterly Report
Open in ViewerOpens in native device viewer
patient in the Phase I ALISON study which evaluates DCP-001 in ovarian cancer.
» Immunicum has taken measurements to enable the continuation of its activities, with minor delays mostly in the planning of its clinical activities, particularly the preparations for the start of the ALISON study, related to Covid-19.
» 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.
| 2021 | 2020 | 2021 | 2020 | 2020 | |
|---|---|---|---|---|---|
| KSEK unless otherwise stated | apr-jun | apr-jun | jan-jun | jan-jun | Full year |
| Operating profit/loss | -31,278 | -12,625 | -72,057 | -23,858 | -86,027 |
| Net profit/loss | -32 ,130 | -13,390 | -73,701 | -25,408 | -89,248 |
| Earnings/loss per share, | |||||
| before and after dilution (SEK) | -0,19 | -0,18 | -0,44 | -0,34 | -1,17 |
| Cash | 211,709 | 25,290 | 211,709 | 25,290 | 167,643 |
| Shareholders equity | 716,092 | 5,997 | 716,092 | 5,997 | 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 second quarter of 2021, Immunicum completed the transition phase of the merger with DCPrime and we are now able to reap the full benefits from the combination. Immunicum has become an integrated, international organization with an advanced clinical pipeline.
The Company addresses key challenges in cancer therapy and houses strong R&D capabilities, based on scientific leadership in the field of allogeneic dendritic cell biology. A new focused management team and organization was presented at an investor event held in April and following the AGM in May the supervisory board was strengthened with the addition of Dr Hans Preusting, who brings extensive process development, manufacturing and business expertise. In addition, we completed a directed placement to Swedish and international investors in June, to support ongoing clinical studies, in-house process development activities, preclinical research programs and general corporate purposes. The financing raised gross proceeds of SEK 141.2 million and benefitted from strong support by existing investors Van Herk Investments and the Swedish AP4 pension fund.
Immunicum's clinical pipeline today is based on two products, ilixadencel and DCP-001, with similar underlying, allogeneic dendritic cell biology. The mode of action of these products is based on their capacity to engage the immune system in order to address hard-to-treat established tumors and tumor recurrence, representing two major challenges in cancer therapy. Importantly, their allogeneic nature allows for the development of ilixadencel and DCP-001 as off-theshelf products, avoiding the complex logistics of autologous cell-based products and allowing for scalable manufacturing. Finally, both products benefit from excellent safety profiles, making them potential candidates
for combination therapies and maintenance therapies.
»Det finns ett stort antal möjligheter i vår pipeline« Ilixadencel is an intratumoral immune primer consisting of pro-inflammatory dendritic cells derived from healthy donor material, which are administered directly into the tumor microenvironment in order to render tumors more susceptible to the immune system. Ilixadencel has been tested in a range of difficult-to-treat solid tumors, with promising signs of efficacy in a number of potential indications, including renal cell carcinoma, hepatocellular cancer and gastrointestinal stromal tumors. It has a safety profile which is supportive to combine ilixadencel with other cancer therapies such as tyrosine kinase inhibitors and immune checkpoint inhibitors. The latter was confirmed by the positive evaluation in July by the Data Safety and Monitoring Board of the data from the ongoing ILIAD Phase Ib study, testing ilixadencel in combination with the leading anti-PD1 checkpoint inhibitor Keytruda® (pembrolizumab) in multiple solid tumor indications. Immunicum is in the process of evaluating all currently available clinical data for ilixadencel from completed studies and the ongoing ILIAD study to determine, together with clinical experts, the most relevant and competitive positioning in the cancer therapy landscape. We will provide an update on the clinical development strategy for ilixadencel by the end of 2021.
»There are a vast number of opportunities in our pipeline« DCP-001 is a cancer relapse vaccine derived from the proprietary DCOne® leukemic cell line. Tumor recurrence, also called relapse, limits the effectiveness and duration of clinical responses of currently available cancer therapies. Relapse vaccination aims to boost the immune system to control residual disease following initial treatment, in order to prevent or delay relapse. Acute myeloid leukemia (AML) is a blood-borne tumor with a high probability of relapse following initial treatment. A significant group of AML patients cannot undergo a
potential life-saving hematopoietic stem cell transplantation, which leaves a largely unmet medical need for novel maintenance therapies. Building on a successful Phase I study, Immunicum is currently conducting the ADVANCE II international Phase II clinical study focused on AML patients with measurable residual disease, which is related to a high probability of relapse. The Company presented immunomonitoring data from the ADVANCE II study at the European Hematology Association conference in June, demonstrating induced systemic immune responses to multiple tumor-associated antigens following DCP-001 vaccination. We also presented preclinical data underlining the combination potential of DCP-001 with currently available and upcoming new therapies 5'-azacytidine and venetoclax. In a humanized mouse model for AML, DCP-001 vaccination led to similar tumor reduction as observed with 5'-azacytidine+venetoclax treatment, whereas the combination of both was the most efficient therapy for disease inhibition. The Company will provide an update of the now fully enrolled ADVANCE II study in the fourth quarter of 2021. In the second quarter of 2021 Immunicum initiated a single-center feasibility study for DCP-001 vaccination in ovarian cancer, which is among the deadliest gynecological cancers due to a high recurrence rate. The study is carried out in collaboration with the renowned group of Prof Dr
Hans Nijman at the University Medical Hospital in Groningen. The regulatory path for DCP-001 was facilitated by an Advanced Therapy Medicinal Product classification received from the European Medicines Agency in June.
Next to developing potential new therapeutic concepts and providing a rationale for novel combination therapies, the Research group focused on advancing our understanding of allogeneic dendritic cell biology. A study describing the interactions between DCP-001 and antigen-presenting cells was presented at the CIMT conference in May, providing further support for the proposed mode of action of DCP-001 and potential new combination therapies with inhibitors of the CD47 pathway, a potential new class of cancer drugs with encouraging signs of efficacy in blood-borne and solid tumors. Next to its in-house research, Immunicum collaborates with academic and industry partners, including ongoing collaborations with PCI Biotech and Glycotope. In the second quarter we expanded our academic network with a research collaboration with the laboratory of Prof. Nina Bhardwaj at the Icahn School of Medicine at Mount Sinai in New York City, a leading group in the field of human dendritic cell biology. Furthermore, the Company's intellectual property basis was
strengthened by broadening the basis for its US patent covering the DCOne® platform and a newly issued US patent covering novel therapies based on the combination of vaccination and intratumoral immune priming. As part of the integration process with DCPrime, Immunicum transferred the process development activities for ilixadencel to its in-house Process Development group and our expanded R&D department is preparing to move to new facilities in Leiden, The Netherlands in early 2022.
In the past six months, Immunicum has made significant progress in the realization of our ambition to become a fully integrated, biopharmaceutical company addressing key challenges in cancer therapy. We continue on this path with confidence, including the preparations for our new R&D facilities, further updates of our clinical pipeline strategy and a critical clinical read-out from the ADVANCE II study expected in the second half of 2021.
As CEO, I thank the Immunicum team and all of Immunicum's stakeholders for being part of this journey.
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 a recent 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 later this year and will provide further guidance on the clinical development plan for ilixadencel before the end of 2021.
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 were 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 is expanding 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 corporate development, including the expansion of its facilities in Leiden, The Netherlands.
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 second quarter - (-). Other operating income amounted to KSEK 24 (-) for the second quarter and to KSEK 277 (-) for the first half year and consisted of exchange rate gains on accounts payable. *
Total operating expenses for the second quarter amounted to KSEK 31,302 (12,625) and to KSEK 72,355 (23,858) for the first half 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. The increased costs during the second quarter, compared with last year, are mainly due to accounting-related principles with respect to the reverse acquisition. *
Research and development costs for the second quarter amounted to KSEK 21,756 (9,792) and to KSEK 51,143 (18,614) for the first half year. The costs are mainly related to preclinical and process development activities, as well as product manufacturing and the ILIAD and ADVANCE II clinical trials. The increased costs during the second quarter, compared with last year, are mainly due to accounting-related principles with respect to the reverse acquisition.
Administrative expenses for the first quarter amounted to KSEK 9,373 (2,823) and to KSEK 20,688 (5,242) for the first half year. The increased costs for the quarter and for the half 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 -31,278 (-12,625). The result for the half year amounted to KSEK –72,057 (-23,858). Earnings per share before and after dilution amounted to SEK -0.19 (-0.18) for the quarter and to SEK -0.44 (-0.34) for the half year
No tax was reported for the quarter - (-).
Cash flow from operating activities for the second quarter amounted to KSEK -35,362 (-13,923) and to KSEK -83,143 (-29,110) for the first half 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 second quarter 2021 compared to 2020 is due to accounting-related principles with respect to the reverse acquisition.*
During the second quarter cash flow from investing activities amounted to KSEK -241 (-319) and to KSEK -1,280 (-454) for the first half year. Cash flow from financing activities for the second quarter amounted to KSEK 128,587 (-3,638) and to KSEK 128,587 (40,948) for the first half year. Cash flow from financing activities is mainly related to an equity raise during the second quarter.
The Company's cash and cash equivalents on June 30, 2021 amounted to KSEK 211,709 (25,290).
Total equity as of June 30, 2021 amounted to KSEK 716,092 (5,997), which corresponds to SEK 3.59 (0.08) per share. The Company's equity ratio at the end of the quarter was 93% (12%).
* 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.
Parent Company Immunicum AB
No revenue was reported for the second quarter nor the first half year - (-). Other operating income amounted to KSEK 24 (1,124) for the second quarter and KSEK 277 (1,214) for the first half year and consisted of exchange rate gains on accounts payable.
Total operating expenses for the first quarter amounted to KSEK 15,708 (26,275) and to KSEK 39,736 (60,235) for the first half year. The operating expenses are primarily due to clinical trials, and process development for ilixadencel. The lower costs during the second quarter, compared with last year, is mainly due to lower CMC/production costs.
Research and development costs for the second quarter amounted to KSEK 9,222 (17,690) and to KSEK 24,834 (41,146) for the first half year. The costs are mainly due to activities in ongoing clinical and preclinical studies. The lower costs for the second quarter, compared to last year, are primarily due to lower CMC expenses.
Administrative expenses for the second quarter amounted to KSEK 6,306 (8,272) and to 14,392 (17,849) for the first half year. Included costs among administration (G&A) are mainly attributable to the finance department, executive management and business development.
Operating result for the second quarter was KSEK -15,684 (-25,151) and for the first half year KSEK -39,459 (-59,021). The result for the second quarter amounted to KSEK -15,684 (-26,411,) and to KSEK -39,455 (-58;124) for the half year. Earnings per share before and after dilution for the Parent Company amounted to SEK -0.09 (-0.29) for the second quarter and to SEK -0.23 (-0.63) for the first half year.
No tax was reported for the second quarter or the first half year - (-).
Cash flow from operating activities for the quarter amounted to KSEK -17,097 (-29,970). The negative cash flow is according to development plan and is mainly explained by the Company's clinical research and activities related to the process development for the manufacturing of ilixadencel.
During the second quarter cash flow from investing activities amounted to KSEK - (-) and to KSEK -30,113 (-) for the first half year. The cash flow during the first half year is related to a shareholders contribution to DCprime. The cash flow from financing activities amounted to KSEK 129,142 (-11) for the second quarter and to KSEK 129,142 (-11) for the first half year and is related to an equity raise in the second quarter.
The Company's cash and cash equivalents on June 30, 2021 amounted to KSEK 210,148 (232,176).
Total equity as of June 30, 2020 amounted to KSEK 815,811 (214,646), which corresponds to SEK 4.09 (2.33) per share. The Company's equity ratio at the end of the quarter was 99% (89%).
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 coworkers in line with the interest of the shareholders. There is currently one outstanding incentive program in the Company. In accordance with a decision by the Annual General Meeting in April 2019, a share-based incentive 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 employees 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 commencing on May 28, 2022 up to and including July 28, 2022.
As of June 30, 2021, the Group had 29 (20) fulltime employees, 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 June 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 | 87,425,934 | 43,84% |
| Fourth Swedish National Pension Fund | 19,250,980 | 9,65% |
| Avanza Pension | 9,648,863 | 4,84% |
| Nordnet Pension | 6,657,358 | 3,34% |
| Loggen Invest AB | 3,100,000 | 1,55%% |
| Holger Blomstrand Byggnads AB | 2,975,386 | 1,49% |
| Erik Manting | 1,064,824 | 0,53% |
| Swedbank Funds | 927,876 | 0,47% |
| Elivågor AB | 875,000 | 0,44% |
| Ivar Nordqvist | 830,256 | 0,42% |
| Handelsbanken Funds | 821,784 | 0,41% |
| Alex Karlsson-Parra | 621,736 | 0,31% |
| Hans Edvin Ståhlgren | 600,000 | 0,30% |
| Jeroen Rovers | 534,000 | 0,27% |
| Other | 63,391.602 | 31,79% |
| Total | 199,400,599 | 100,00% |
This report has not been reviewed by the Company's auditor.
| 2021 | 2020 | 2021 | 2020 | 2020 | |
|---|---|---|---|---|---|
| Amounts in KSEK | apr-jun | apr-jun | jan-jun | jan-jun | jan-dec |
| Other operating income | 24 | – | 277 | – | 16,675 |
| 24 | – | 277 | – | 16 675 | |
| OPERATING EXPENCES | |||||
| Administration expenses | -9,373 | -2,823 | -20,688 | -5,242 | -38,080 |
| Research and development expenses | -21,756 | -9,792 | -51,128 | -18,614 | -47,883 |
| Other operating expenses | -173 | -11 | -519 | -2 | -65 |
| Operating profit/loss | -31,278 | -12,625 | -72,057 | -23,858 | -86,027 |
| RESULT FROM FINANCIAL ITEMS | |||||
| Financial income | – | – | – | – | – |
| Financial costs | -852 | -764 | -1,643 | -1,550 | -3,220 |
| Profit/loss after financial items | -32,130 | -13,390 | -73,701 | -25,408 | -89,248 |
| TOTAL PROFIT/LOSS BEFORE TAXES | -32,130 | -13,390 | -73,701 | -25,408 | -89,248 |
| Income tax expense | – | – | – | – | – |
| PROFIT/LOSS FOR THE PERIOD | -32,130 | -13,390 | -73,701 | -25,408 | -89,248 |
| Earnings/loss per share before and after dilution (SEK), for profit attributable to owner of the parent company's shareholders. |
|||||
| -0,19 | -0,18 | -0,44 | -0,34 | -1,17 |
| Amounts in KSEK | 2021 apr-jun |
2020 apr-jun |
2021 jan-jun |
2020 jan-jun |
2020 jan-dec |
|---|---|---|---|---|---|
| Result for the period Other comprehensive income |
-32,130 | -13,390 | -73,701 | -25,408 | -89,248 |
| Exchange differences on translation of foreign operations |
-15 | -119 | -440 | -1,713 | 3,231 |
| Other comprehensive income for the period | -15 | -119 | -440 | -1,713 | 3,231 |
| Total comprehensive income for the period | -32,145 | -13,508 | -74,141 | -27,121 | -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 jun 2021 | 30 jun 2020 | 30 dec 2020 |
|---|---|---|---|
| ASSETS | |||
| NON-CURRENT ASSETS | |||
| Goodwill | 108,350 | – | 108,350 |
| Technology | 424,091 | – | 424,091 |
| Right-of-use assets | 786 | 1,701 | 1,204 |
| Equipment | 2,546 | 2,201 | 1,705 |
| Other long term receivables | 682 | 444 | 677 |
| Total Non-current assets | 536,456 | 4,346 | 536,028 |
| CURRENT ASSETS | |||
| Other receivables | 17,289 | 18,252 | 20,230 |
| Prepaid expenses and accrued income | 7,075 | 415 | 4,760 |
| Cash and cash equivalents | 211,709 | 25,290 | 167,643 |
| Total current assets | 236,073 | 43,958 | 192,634 |
| TOTAL ASSETS | 772,528 | 48,304 | 728,661 |
| SHAREHOLDERS' EQUITY AND LIABILITIES SHAREHOLDERS' EQUITY Share capital Additional paid-in capital Reserves |
9,970 1,130,525 3,087 |
586 296,771 -1,412 |
8,308 1,003,044 3,532 |
| Retained earnings | |||
| (including profit/loss for the period) | -427,485 | -289,947 | -353,790 |
| Total equity attributable to the shareholders of the parent company | 716,092 | 5,997 | 661,094 |
| LIABILITIES NON-CURRENT LIABILITIES |
|||
| Other long-term liabilities | 35,499 | 36,470 | 18,982 |
| Lease liabilities | – | 782 | 303 |
| Total non-current liabilities | 35,499 | 37,251 | 19,285 |
| CURRENT LIABILITIES | |||
| Lease liabilities | 755 | 897 | 880 |
| Accounts payable | 8,824 | 1,891 | 10,365 |
| Other liabilities | 6,415 | 1,970 | 23,179 |
| Accrued expenses and deferred income | 4,942 | 297 | 13,857 |
| Total current liabilities | 20,937 | 5,055 | 48,282 |
| Total liabilities | 56,436 | 42,306 | 67,567 |
| TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES | 772,528 | 48,304 | 728,661 |
Attributable to owners of Immunicum AB (publ)
| Additional | Retained earnings inc. |
||||
|---|---|---|---|---|---|
| Share | paid in | profit/loss for | |||
| Amounts in KSEK | capital | capital | Reserves | the period | Totalt |
| Opening shareholders' equity 01/01/2021 | 8,308 | 1,003,044 | 3,532 | -353,789 | 661,096 |
| Profit/loss for the period | – | -73,701 | -73,701 | ||
| Other comprehensive income | – | – | -440 | – | -440 |
| Total comprehensive income | – | – | -440 | -73,701 | -74,141 |
| Transactions with owners | – | – | – | – | – |
| Share issue | 1,662 | 139,581 | – | – | 141,242 |
| Costs for new share issue | – | -12 ,100 | – | – | -12,101 |
| Shareholders' contribution | – | – | – | – | – |
| Total transaction with owners | 1,662 | 127,481 | – | – | 129,142 |
| Shareholders' equity 30/06/2021 | 9,970 | 1,130,525 | 3,092 | -427,489 | 716,097 |
| Opening shareholders' equity 01/01/2020 | 586 | 257,980 | 301 | -264,541 | -5,674 |
| Profit/loss for the period | – | -25,408 | -25,408 | ||
| Other comprehensive income | – | – | -1,713 | – | -1,713 |
| Total comprehensive income | – | – | -1,713 | -25,408 | -27,121 |
| Transactions with owners | – | – | – | – | – |
| Shareholders' contribution | – | 38,791 | – | – | 38,791 |
| Total transaction with owners | – | 38,791 | – | – | 38,791 |
| Shareholders' equity 30/06/2020 | 586 | 296,771 | -1,432 | -289,949 | 5,977 |
| 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 |
|---|---|---|---|---|---|
| apr-jun | apr-jun | jan-jun | jan-jun | jan-dec | |
| Operating activities | |||||
| Operating profit/loss | -31,278 | 12,625 | -72,058 | 23,853 | -86,029 |
| Adjustment for items not included in cash flow | 474 | 455 | 663 | 656 | 1,774 |
| Interest expense paid | -64 | -25 | -66 | -27 | -103 |
| Cash flow from operating activities before | |||||
| changes in working capital | -30,868 | -12,195 | -71,462 | 23,224 | -84,358 |
| Increase/decrease in other current receivables | 1,801 | –246 | 972 | 545 | 22,204 |
| Increase/decrease in accounts payable | -2,780 | -458 | -1,715 | -15 | 761 |
| Increase/decrease in other current liabilities | -3,315 | -1,024 | -10,939 | -6,416 | 4,766 |
| Cash flow from operating activities | -35,362 | -13,923 | -83,143 | -29,110 | -56,626 |
| Investment activities | |||||
| Investments in tangible assets | -241 | -319 | -1,280 | -454 | -464 |
| Investment in financial fixed assets | – | – | – | – | |
| Acquistion of business | – | – | – | – | 157,762 |
| Cash flow from investing activities | -241 | -319 | -1,280 | -454 | 157,298 |
| Financing activities | |||||
| Shareholders contribution | – | – | – | 37,310 | 53,681 |
| New share issues | 141,242 | – | 141,242 | – | – |
| New share Issue costs | -12,100 | – | -12,100 | – | -2,052 |
| Proceeds from borrowings | – | 3,859 | – | 3,859 | 3,798 |
| Repayment of borrowings | -555 | 221 | -555 | 221 | -4,523 |
| Cash flow from financing activities | 128,587 | 3,638 | 128,587 | 40,948 | 50,904 |
| Cash and cash equivalents at the | |||||
| beginning of the period | 118,960 | 36,348 | 167,643 | 14,071 | 14,032 |
| Cash flow for the period | 92,984 | -10,604 | 44,165 | 11,385 | 151,576 |
| Foreign echange difference in | |||||
| cash and cash equivalents | -235 | -455 | -98 | -167 | 2,035 |
| Cash and cash equivalents at the | |||||
| end of the period | 211,709 | 25,289 | 211,709 | 25,289 | 167,643 |
| Amounts in KSEK | 2021 apr-jun |
2020 apr-jun |
2021 apr-jun |
2020 jan-jun |
2020 jan-jun |
|---|---|---|---|---|---|
| Other operating income | 24 | 1,124 | 277 | 1, 214 | 2,444 |
| 24 | 1,124 | 277 | 1,214 | 2,444 | |
| OPERATING EXPENSES | |||||
| Sales, general and administration expenses | -6,306 | -8,272 | -14,392 | -17,849 | -27,726 |
| Research and development expenses | -9,222 | -17,690 | -24,834 | -41,146 | -79,191 |
| Other operating expenses | -180 | -313 | -510 | -1,240 | -2,148 |
| Operating profit/loss | -15,684 | -25,151 | -39,459 | -59,021 | -106,621 |
| Net financial items | – | -1,260 | 4 | 897 | 313 |
| Interest expense and similar items | |||||
| Profit/loss after financial items | -15,684 | -26,411 | -39,455 | -58,124 | -106,308 |
| Income tax expense | – | – | – | – | – |
| PROFIT/LOSS FOR THE PERIOD | -15,684 | -26,411 | -39,455 | -58,124 | -106,308 |
| Earnings/loss per share | |||||
| before and after dilution (SEK) | -0,09 | -0,29 | -0,23 | -0,63 | -1,13 |
| Amounts in KSEK | 2021 | 2020 | 2021 | 2020 | 2020 |
|---|---|---|---|---|---|
| apr-jun | apr-jun | apr-jun | jan-jun | jan-jun | |
| Result for the period | -15,684 | -26,411 | -39,455 | -58,124 | -106,308 |
| Other comprehensive income | – | – | – | – | – |
| Total comprehensive result for the period | -15,684 | -26,411 | -39,455 | -58,124 | -106,308 |
| Amounts in KSEK | 2021-06-30 | 2020-06-30 | 2020-12-31 |
|---|---|---|---|
| ASSETS | |||
| FIXED ASSETS | |||
| Tangible assets | – | – | – |
| Equipment | – | – | – |
| Total tangible assets | – | – | – |
| Financial assets | – | – | – |
| Participants in Group companies | 608,853 | – | 578,311 |
| Other long term receivables | 252 | 252 | 252 |
| Total financial assets | 609,105 | 252 | 578,563 |
| Total fixed assets | 609,105 | 252 | 578,563 |
| Total fixed assets | |||
| Current receivables | – | – | – |
| Other receivables | 142 | 2,179 | 3,333 |
| Prepaid expenses and accrued income | 5,764 | 7,524 | 4,509 |
| Total current receivables | 5,906 | 9,703 | 7,842 |
| Cash and bank balances | 210,148 | 232,176 | 157,762 |
| Total current assets | 216,054 | 241,879 | 165,604 |
| TOTAL ASSETS | 825,158 | 242,131 | 744,167 |
| SHAREHOLDERS' EQUITY AND LIABILITIES | |||
| SHAREHOLDERS' EQUITY | |||
| Restricted equity Share capital |
– 9,970 |
– 4,613 |
– 8,308 |
| New share issue in progress | – | – | – |
| Total restricted equity | 9,970 | 4,613 | 8,308 |
| Unrestricted equity | – | – | – |
| Share premium reserve | 1,415,264 | 731,818 | 1,287,784 |
| Retained earnings | -593,739 | -463,661 | -463,661 |
| Profit/loss for the period | -15,684 | -58,124 | -106,308 |
| Total unrestricted equity | 805,841 | 210,033 | 717,815 |
| Total shareholders' equity | 815,811 | 214,646 | 726,123 |
| LIABILITIES | |||
| LONG-TERM LIABILITIES | – | – | – |
| Other long-term liabilities | 850 | 850 | 850 |
| Total long-term liabilities | 850 | 850 | 850 |
| CURRENT LIABILITIES | |||
| Accounts payable | 5,695 | 20,558 | 7,811 |
| Other liabilities | -1,356 | 1,385 | 2,013 |
| Accrued expenses and deferred income | 4,157 | 4,692 | 7,369 |
| Total current liabilities | 8,496 | 26,635 | 17,193 |
| Total liabilities | 9,346 | 27,485 | 18,043 |
| TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES | 825,158 | 242,131 | 744,167 |
| Retained | ||||
|---|---|---|---|---|
| Share | 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 | – | – | -39,455 | -39,455 |
| Comprehensive result for the period | – | – | -39,455 | -39,455 |
| Transactions with owners | ||||
| Share issue | 1,662 | 139,580 | – | 141,242 |
| Costs for new share issue | – | -12 ,100 | – | -12,100 |
| Total transaction with owners | 1,662 | 127,480 | – | -129,142 |
| Shareholders' equity 30/06/2021 | 9,970 | 1,415,264 | -609,424 | 815,810 |
| Opening shareholders' equity 01/01/2020 | 4,613 | 731,828 | -463,661 | 272,780 |
| Profit/loss for the period | – | – | -57,624 | -57,624 |
| Comprehensive result for the period | – | – | -57,624 | -57,624 |
| Transactions with owners | ||||
| Premiums for warrants | – | -11 | – | -11 |
| Total transaction with owners | – | -11 | – | -11 |
| Shareholders' equity 30/06/2021 | 4,613 | 731,828 | -521,285 | 215,145 |
| 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 | 2020 | 2020 | 2020 | |
|---|---|---|---|---|---|
| Amounts in KSEK | apr-jun | apr-jun | jan-mars | jan-juni | jan-dec |
| Operating activities | |||||
| Operating profit/loss before financial items | -15,684 | -25,152 | -39,460 | -59,021 | -106,621 |
| Adjustment for items not included in cash flow | – | – | – | – | – |
| Interest income received | – | – | – | – | 15 |
| Interest expense paid | – | -2 | – | -2 | -2 |
| Increase/decrease in accounts receivable | – | – | – | – | – |
| Increase/decrease in other current receivables | 1,341 | -4,453 | 1,937 | -2,936 | -1,076 |
| Increase/decrease in accounts payable | -512 | 8,401 | -2,116 | 7,739 | -5,008 |
| Increase/decrease in other current liabilities | -2,242 | -8,765 | -6,582 | -11,303 | -7,998 |
| Cash flow from operating activities | -17,097 | -29,970 | -46,221 | -65,523 | -120,690 |
| Investment activities | |||||
| Investment in financial assets | – | – | -30,113 | – | -16,597 |
| Cash flow from investing activities | – | – | -30,113 | – | -16,597 |
| Financing activities | |||||
| Shareholders contribution | – | – | – | – | – |
| New share issues | 141 ,242 | … | 141,242 | – | -2,052 |
| New share Issue costs | -12 100 | – | -12 100 | – | – |
| Premiums for repurchased warrants | – | -11 | – | -11 | -187 |
| Cash flow from financing activities | 129,142 | -11 | 129 142 | -11 | -2,063 |
| Cash and cash equivalents at the | |||||
| beginning of the period | 98,101 | 263,416 | 157,762 | 296,811 | 296,811 |
| Cash flow for the period | 112,045 | -29,981 | 52,808 | -65,534 | -139,350 |
| Foreign echange difference in cash | |||||
| and cash equivalents | -1 | -1,258 | -422 | 899 | 300 |
| Cash and cash equivalents at | |||||
| the end of the period | 210,148 | 232,176 | 210,148 | 232,176 | 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 Gothenburg and with its registered office in Stockholm. The quarterly report was authorized for issue by the Board of Directors on August 25, 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 and will be described in the Annual Report (note 2 page 55-59)
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. 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 II ADVANCE II and 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 first half year invoiced the Company KSEK 1,842 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 first half year 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 in the first half year invoiced Immunicum KSEK 1,473 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.
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.
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 measurements, including two measurements that are not defined under IFRS, namely expenses relating to research and development/operating expenses % and equity ratio. These financial performance measurements 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 measurements as the Company has defined it should not be compared with other performance measurements with similar names used by other companies. This is because the above-mentioned performance measurements is not always defined in the same manner, and other companies may calculate them differently to Immunicum.
| 2021 apr-juni |
2020 apr-juni |
2021 jan-juni |
2020 jan-juni |
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 | 716,092 | 5,997 | 716,092 | 5,997 | 661,094 |
| Earnings per share before and after dilution, SEK | -0,19 | -0,18 | -0,44 | -0,34 | -1,17 |
| Research and development costs, KSEK | -21,756 | -9,792 | -51,128 | -18,614 | -48,980 |
| Research and development costs/operating expenses, % | 70% | 78% | 71% | 78% | 57% |
| 2021 apr-jun |
2020 apr-jun |
2021 jan-jun |
2020 jan-jun |
2020 jan-dec |
|
|---|---|---|---|---|---|
| Total registered shares at the beginning of period | 166,167,166 | 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 | 4,612 | 9,970 | 4,612 | 8,308 |
| Equity at the end of period, SEK thousand | 815,811 | 214,646 | 815,811 | 214,646 | 726,123 |
| Earnings per share before and after dilution, SEK | -0,09 | -0,29 | -0,23 | -0,63 | -1,13 |
| Research and development costs, SEK thousand | -9,222 | -17,690 | -24,834 | -41,146 | -79,191 |
| Research & development costs/operating expenses % | 59% | 67% | 62% | 68% | 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 apr-jun |
2020 apr-jun |
2021 jan-jun |
2020 jan-jun |
2020 jan-dec |
|
|---|---|---|---|---|---|
| Equity ratio at the end of the period % | |||||
| Total shareholders equity at the end of the period, KSEK | 716,092 | 5,997 | 716,092 | 5,997 | 661,094 |
| Total assest at the end of the period, KSEK | 772,528 | 48,304 | 772,528 | 48,304 | 728,661 |
| Equity ratio at the end of the period, % | 93% | 12% | 93% | 12% | 91% |
| Research & Development costs/operating expenses, % | |||||
| Research & Development costs | -21,756 | -9,792 | -51,143 | -18,614 | -47,883 |
| Administrative costs | -9,373 | -2,823 | 20,688 | -5,242 | -38,080 |
| Other operating expenses | -173 | -11 | -519 | -2 | -65 |
| Total operating expenses | -31,302 | -12,625 | 72,335 | -23,858 | -86,027 |
| Research & development costs/operating expenses, % | 70% | 78% | 71% | 78% | 56% |
| 2021 apr-juni |
2020 apr-juni |
2021 jan-juni |
2020 jan-juni |
2020 jan-dec |
|
|---|---|---|---|---|---|
| Equity ratio at the end of the period % | |||||
| Total shareholders equity at the end of the period, KSEK | 815,811 | 214,646 | 815,811 | 214,646 | 726,123 |
| Total assest at the end of the period, KSEK | 825,158 | 242,131 | 825,158 | 242,131 | 744 167 |
| Equity ratio at the end of the period, % | 99% | 89% | 99% | 89% | 98% |
| Research & Development costs/operating expenses, % | |||||
| Research & Development costs - |
9,222 | -17,690 | -24,834 | -41,146 | -79,191 |
| Administrative costs | -6,306 | -8,272 | -14,392 | -17,849 | -27,726 |
| Other operating expenses | -180 | -313 | -510 | -1,240 | -2,148 |
| Total operating expenses | -15,708 | -26,275 | -39,736 | -60,235 | -109,065 |
| Research & development costs/operating expenses, % | 59% | 67% | 62% | 68% | 73% |
Phone: +46 (0)8 732 8400 E-mail: [email protected]
Telephone: +46 (0)8 732 8400 E-mail: [email protected]
Postal address: Östermalmstorg 5 SE- 114 42 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 May 4, 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 Östermalmstorg 5 SE- 114 42 Stockholm, Sweden Phone: +46 (0)8 732 8400
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.