Quarterly Report • Nov 7, 2018
Quarterly Report
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Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies
Positive preclinical results presented at ESMO
| Q3 | Jan - Sept | Full year | ||||
|---|---|---|---|---|---|---|
| KSEK unless otherwise stated | 2018 | 2017 | 2018 | 2017 | 2017 | |
| Operating profit/loss | -23,520 | -21,597 | -71,637 | -61,245 | -80,700 | |
| Net profit/loss | -23,520 | -21,659 | -71,645 | -61,512 | -80,338 | |
| Earnings per share, before and after dilution (SEK) | -0.5 | -0.8 | -1.4 | -2.4 | -3.1 | |
| Cash | 133,273 | 43,586 | 133,273 | 43,586 | 128,883 | |
| Shareholders equity | 117,912 | 40,874 | 117,912 | 40,874 | 189,556 | |
| Number of employees | 11 | 10 | 11 | 10 | 11 |
» Immunicum has taken a series of significant and strategic steps forward during the summer. In these past months, our treatment approach has received validation from investors and the scientific community and we are looking forward to the next development stage for both the research and the company.
In July the U.S. Food and Drug Administration (FDA) cleared the clinical trial protocol for the planned Phase Ib/II trial to evaluate the safety and efficacy of intratumorally-administered ilixadencel in combination with checkpoint inhibitors (CPI). The regulatory approval allows the company to start the process of patient enrollment and we expect the trial to enroll the first patient before the end of the year. This is an important step in the development of ilixadencel.
The positive preclinical results presented at the European Society for Medical Oncology Meeting (ESMO) in October further emphasize the potential of ilixadencel in multiple immuno-oncology treatment combinations. We had the opportunity to meet our ongoing objective of increasing recognition of ilixadencel within the global scientific community through the presentation of in vivo and in vitro data. The results of the study, which were presented to key opinion leaders in the field of immuno-oncology during a poster session, highlight the ability of intratumoral ilixadencel to enhance anti-tumor response and survival of systemic checkpoint inhibitors (anti-PD-1) or immune enhancers (anti-4-1BB/CD137). We will continue to seek opportunities to share and validate our approach with members of the scientific community.
Finally, the proposed directed Issue and fully guaranteed rights Issue are estimated to raise 351 million SEK for the company. The support of a syndicate of high-value and strategic institutional investors indicates the positive direction in which the company continues to move. With greater financial resources we can conduct an expanded combination trial, engage in supportive preclinical trials and make the considerable investment needed to secure product for pivotal studies and future large scale commercial manufacturing of ilixadencel. These investments are key in increasing the value of ilixadencel.
In summary, we continue to successively deliver on our plan and are getting closer to meeting key milestones. We are pleased with the progress we have made and look forward to finishing the year on a strong note.
I want to thank our shareholders for your continued support as we strive to reach our commercial and clinical objectives and work to make a real difference for patients with cancer.
CARLOS DE SOUSA President and CEO
Immunicum is a biopharmaceutical company in clinical stage development of a unique cell-based treatment for cancer.
Our treatment strengthens the ability of the patient immune system to recognize and kill tumor cells. The treatment consists of intratumoral injection of activated dendritic cells that are central parts of the immune defense system.
One major advantage over other cell-based therapies is that our product, ilixadencel, is ready to be used in different patients, and there is no need for costly adaptation to the
individual patient. Ilixadencel is an off-the-shelf product originated from healthy allogeneic blood donors.
Our goal is for Ilixadencel to be included as a key component in most future combination treatments for solid tumors. Ilixadencel is currently being evaluated in two clinical trials for the treatment of various cancers with an additional multi-indication trial in the final stages of preparation.
| Product & Indication | Combination | Preclinical | Phase I/II | Phase II | Phase III | ||
|---|---|---|---|---|---|---|---|
| Ilixadencel: an off-the-shelf cancer immune primer Immunicum's lead product consists of allogeneic pro-inflammatory dendritic cells injected in the patient's tumor to prime and activate the patient's own immune system to recognize and attack the tumor. |
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| Renal cell carcinoma | Kinase inhibitors | ||||||
| Hepatocellular carcinoma | Kinase inhibitors | ||||||
| Gastrointestinal stromal tumors |
Kinase inhibitors | ||||||
| Head and neck squamous cell carcinoma |
Checkpoint inhibitors | ||||||
| Non-small cell lung cancer | Checkpoint inhibitors | Start enrollment 2H2018 | |||||
| Gastric adenocarcinoma | Checkpoint inhibitors | ||||||
| IMM-2: allogeneic dendritic cells with adenovirus coding for tumor antigens Immunicum's proprietary adenovector can be used to deliver genes, coding for oncoviral antigens or neoantigens and immune-boosting factors, into allogeneic dendritic cells, to create a cancer vaccine with optimal immune priming capacity. |
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| Cancer | |||||||
| IMM-3: optimized CAR-T expansion protocol for improved anti-cancer activity Immunicum's CD70 platform uses our core expertise in dendritic cell biology to provide superior expansion of CAR-T cells with improved anti-tumor activity as well as higher resistance to oxidative stress and immunosuppressive factors in the solid tumor environment. |
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| Cancer |
Immunicum's lead product, ilixadencel, is an immune activator or immune primer as it helps to activate the patient's own immune cells to kill cancer cells.
Ilixadencel has been developed in order to be able to take advantage of each patient's unique tumor antigens and to circumvent the need to combine ilixadencel with tumor antigens in test tubes in order to create an effective tumor specific immune primer.
Ilixadencel is made up of allogeneic (from healthy donors), pro-inflammatory dendritic cells and is administered in situ (directly into the tumor). The intratumorally injected allogeneic dendritic cells will be able to survive for 48 to 72 hours after administration and are activated to release immunostimulating factors, including chemokines and cytokines, during that time period. The local production of these factors within the tumor will induce a local recruitment and activation of endogenous immune cells (immune cells from the patient), including natural killer (NK) cells, immature dendritic cells and T cells.
The recruitment of the patient's own dendritic cells will take place inside the tumor, where there are already high levels of tumor specific antigens. The concomitant recruitment and activation of NK cells leads to NK cell-mediated tumor cell death of tumor cells at the injection site where after these can be taken up by the recruited dendritic cells which in this manner will become loaded with antigens. Once the dendritic cells are loaded and activated by the pro-inflammatory environment created by ilixadencel, they will migrate to nearby lymph nodes where they will prime/ activate tumor-specific cytotoxic T cells, including CD8+ T cells that will migrate from the lymph node, through the blood circulation, and then search for and kill tumor cells within both the primary tumor and metastases elsewhere in the body.
As supported by preclinical proof-of-concept data announced in 2017, Immunicum will evaluate ilixadencel as an immune primer in combination with checkpoint inhibitors (CPIs). The trial, abbreviated ILIAD for ILIxadencel in combination with checkpoint inhibitors in ADvanced cancer patients, is an Immunicum-sponsored, randomized, open-label, multicenter Phase Ib/II clinical study. It
ILIAD – design of the Phase Ib part of the study
will test the combination in three indications: head and neck cancer, non-small cell lung cancer and gastric and gastroesophageal junction adenocarcinoma. The trial will be divided into two parts: Phase Ib and Phase II. The aim of the Phase Ib part of the study is to assess safety and define the optimal dose and schedule of ilixadencel administration in combination with standard doses of pembrolizumab (Keytruda®) in patients with any of these three types of cancers.
The protocol was approved by the FDA in July, to enable initiation of the ILIAD study in the US. Based on input from clinical experts and EU regulatory authorities as well as guidance from the FDA, the Phase Ib part of the study will include 21 patients. The first six patients will be enrolled in a staggered format, which means that each patient will be observed for a period of six weeks before the next patient is treated (see image on previous page). Immunicum will test three different dose levels and two different treatment schedules for ilixadencel in combination with the CPI. The protocol is designed to evaluate safety and provide data on the most advantageous dosing and treatment schedules for use in the Phase II. Immunicum expects the first patient to be enrolled in the fourth quarter of 2018.
In September 2017, Immunicum announced the topline results from the completed Phase I/II clinical trial of ilixadencel in 18 advanced liver cancer patients (Hepatocellular carcinoma; HCC). The study was conducted at Sahlgrenska University hospital in Gothenburg, Sweden.
Ilixadencel was shown to be safe and well tolerated in these patients when given both as a single treatment and in combination with the current first line standard treatment, sorafenib. In addition, the results provide evidence of tumor-specific immune activation in the majority of evaluable patients. Based on these positive data, Immunicum will continue to explore the potential of advancing to the next stage of clinical development in this indication based on different strategic and financial opportunities.
The Company has submitted a manuscript describing the previously announced data in more detail to a scientific journal for publication.
Immunicum is presently conducting an international, investigational, randomized, controlled and open Phase II study (MERECA). Patient recruitment for the MERECA study was completed on January 8th, 2018. A total of 88 newly
diagnosed metastatic renal cancer (mRCC) patients were included. 58 patients received treatment with ilixadencel in combination with subsequent nephrectomy (the removal of the tumor affected kidney) as well as the standard treatment with tyrosine kinase inhibitor Sutent® (sunitinib). Thirty patients in the control group undergo only nephrectomy and standard treatment with Sutent®.
The primary purpose of the MERECA study is to investigate the clinical efficacy of treatment with ilixadencel in combination with sunitinib in newly diagnosed mRCC patients. The primary endpoints for the MERECA study are median Overall Survival (mOS) and median survival rate after 18 months for all patients and for the patient-groups with poor and intermediate prognosis. In addition to these primary parameters, the Company will also study the frequency and proportion of adverse events (AEs), progression-free survival (PFS), objective tumor response after introduction of Sutent® (sunitinib), time to progression (TTP) and intratumoral infiltration of CD8+ T cells in primary tumors and accessible metastases, compared with normal tissue.
The primary analysis and top-line results are planned to be completed during the third quarter 2019.
Immunicum's Phase I/II study included twelve patients with newly diagnosed metastatic renal cell carcinoma (mRCC). In March 2014 the concluding report was presented, and no treatment-related serious adverse events were noted. The report presented a hitherto achieved median survival time for patients with poor prognosis in excess of the expected median survival time that prevails for established pharmaceuticals, which are also often associated with undesirable side effects. The data also show clear signs of tumor-specific immune activation. Immunicum published the data from the Phase I/II Study in the Journal for ImmunoTherapy of Cancer in June 2017, which contained follow-up data of patients up to December 2016. Updated survival time data, as per May 2017, from the Phase I/II Study, showed that five of eleven evaluable patients were alive at that point in time. At the last update of survival time data in January 2018 three of eleven evaluable patients were still alive. One of the patients had by then survived 50 months after beginning of treatment and the other two 60 months.
Immunicum is presently carrying out a Phase I/II clinical trial with ilixadencel concerning the treatment of patients with gastrointestinal stromal tumors (GIST). The clinical trial is conducted at the Karolinska University Hospital in Stockholm, Sweden.
The primary objective of the clinical trial is to examine whether ilixadencel in combination with a tyrosine kinase inhibitor is safe and tolerable for these patients. Additional clinical endpoints, such as objective response and progression-free survival (PFS), will also be evaluated.
The sixth and last patient was enrolled in the first cohort of the clinical trial during May. Due to the rarity of the disease, which has caused the enrollment to be slow, Immunicum decided not to proceed with the recruitment of the remaining 6 patients in the second cohort. From the patients enrolled so far in the trial, the safety and tolerability of ilixadencel is positive and in line with results from the previous trials. The Company will announce the topline results in mid-2019.
Immunicum has performed preclinical studies in a mouse tumor model where cancer cells (CT26; coloncarcinoma) is injected subcutaneously followed by treatment with checkpoint inhibitors (anti-PD1) or immune enhancers (anti-4-1BB/CD137). These two emerging classes in the immuno-oncology field block the tumor's defenses against the activated immune system (anti-PD-1), or expand and further potentiate the activated immune system, and are therefore highly complementary to ilixadencel's mechanism of action in activating the immune system. As shown below, ilixadencel showed synergy in reducing tumor growth and increasing survival in combination with both classes, further positioning our strategy for ilixadencel to be included as a key component in future combination therapies for solid tumors.
IMM-2 (formerly SUBCUVAX® ) shares the same technology basis as used for production of ilixadencel to benefit from the unique priming and activating technology. The major difference between IMM-2 and ilixadencel is that IMM-2 is combined with tumor antigens, including tumor neoantigens in a test tube and is injected subcutaneously (under the skin), as opposed to ilixadencel's intratumoral injection.
The adenovirus vector was acquired in 2014 with the purpose of being included in the IMM-2 concept. Nonclinical studies with the adenovirus vector for the development of IMM-2 are in progress in cooperation with the University of Uppsala and Professor Magnus Essand.
The objective is to examine the possibilities of using the vector for the production of relevant tumor antigens to be used in the IMM-2 immune priming and activating cells.
Immunicum's IMM-3 platform (formerly CD70) is positioned as a strategy that can be used to improve existing and new adoptive immunotherapeutics. Adoptive immunotherapy utilizes the patient's own T cells, which are isolated and usually genetically manipulated to specifically recognize cancer cells; such cells are termed CAR-T cells. The primary goal is to establish the IMMU-3-concept as an optimal method for the ex-vivo expansion of CAR-T cells for the treatment of solid tumors.
During the quarter other operating income amounted to KSEK 7 (KSEK 73) for the quarter and to KSEK 146 (KSEK 135) for the period and consisted of exchange gains.
From 2018 Immunicum will report according to an income statement classified by function instead of classified by nature of expense. This is because the company has high costs for clinical studies and staff in research and development, which is now being better presented. These have previously been reported as external costs and personnel costs.
Administrative cost amounted to KSEK 6,105 (KSEK 4,834) during the quarter and to KSEK 18,453 (KSEK 16,674) during the period. The cost consisted of consultancy costs, business development costs, marketing activities and personnel costs as well as other administrative costs as rent, auditors and legal fees. During the period the administrative costs were to a large part consulting and legal fees for the listing on Nasdaq main market.
Costs for research and development for the period amounted to KSEK 17,204 (KSEK 16,836) and for the period to KSEK 52,259 (KSEK 44,563) and includes costs for work prior to the start of the clinical multi indication study in which the first patient is expected to be included in the fourth quarter of 2018. A substantial part of the costs also refers to work in the MERECA study as well as product development.
Operating loss amounted to KSEK -23,520 (KSEK -21,597) for the quarter and to KSEK -71,637 (KSEK -61,245) for the period. Net loss amounted to KSEK -23,520 (KSEK -21,659) for the quarter and to KSEK -71,645 (KSEK -61,512) for the period. Earnings per share before and after dilution amounted to SEK -0.5 (SEK -0.8) for the quarter and to SEK -1.4 (SEK -2.4) for the period.
Cash flow relating to operating activities amounted to KSEK -16,698 (KSEK -17,620) and to KSEK -100,850 (KSEK -59,313) for the period. The increased negative cash flow for the period is due to that the company has been increasing the development speed in line with the development plan.
Cash flow from financing activities amounted to KSEK 0 (KSEK 0) and to KSEK 105,239 (KSEK 0) for the period, which relates to a partial payment of the new share issue completed at year-end.
The Company's cash and cash equivalents at September 30, 2018 amounted to KSEK 133,273 (KSEK 43,586). In addition, during the comparison period KSEK 9,527 was invested in the fund of a Swedish bank.
Total shareholders' equity at 30 September 2018 amounted to KSEK 117,912 (KSEK 40,874), which corresponds to SEK 2.3 (SEK 1.57) per share.
The Company's equity ratio at the end of the period was 85% (69%).
The equity ratio is an alternative performance measure and has been calculated as shareholders' equity for the period divided by balance sheet total for the period. The Company believes that this key ratio provides investors with useful information of the Company's capital structure.
The shares have been traded on NASDAQ First North under the ticker symbol IMMU, with the ISIN code SE0005003654 since 22 April 2013, and with a listing on the First North Premier segment as of 4 May 2016. As of 15 January 2018, the shares are traded on Nasdaq Stockholm's main market.
The number of shares in the Company as of 30 September 2018 amounts to 50,958,531 (25,958,541).
Immunicum has chosen to conduct its business operations with a minimal number of employees on staff supple-mented by consultants, in order to maintain flexibility and cost effectiveness. As of 30 September 2018, the Company had 11 (10) direct employees, of whom 6 (5) were women and 5 (5) men.
Margareth Jorvid, Head of Regulatory Affairs and Quality System, and member of Immunicum's management team has invoiced Immunicum KSEK 442 in consultancy fees through the company Methra in Uppsala AB during the third quarter. Pricing has been made on commercial terms.
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.
For a more detailed description of the material risk factors, please refer to Immunicum's most recent prospectus (Prospectus for the Preferential Rights Share Issue 2017) and Annual Report which can be downloaded from the Company's website: www.immunicum.com.
There are currently no outstanding warrants or other equity-related incentive programs in the Company.
| Year-End report 2018 | 15 February 2019 |
|---|---|
Annual General Meeting 25 April 2019
| Owners | Shares | Votes |
|---|---|---|
| Avanza Pension | 4,545,181 | 8.92% |
| Martin Lindström | 3,000,101 | 5.89% |
| Holger Blomstrand Byggnads AB | 2,975,386 | 5.84% |
| Nordnet Pensionsförsäkring | 2,752,980 | 5.40% |
| Rothesay Ltd | 1,000,000 | 1.96% |
| Ålandsbanken I Ägares Ställe | 970,811 | 1.91% |
| Swedbank Robur Fonder | 725,000 | 1.42% |
| Abn Amro Global Custody Services Nv | 660,051 | 1.30% |
| C. Hansen Invest ApS | 650,000 | 1.28% |
| Alex Karlsson-Parra | 617,736 | 1.21% |
| Bengt Andersson | 571,319 | 1.12% |
| BISP Invest AB | 565,950 | 1.11% |
| Others | 31,924,016 | 63% |
| In total | 50,958,531 | 100.00% |
| Amounts in KSEK | 2018-07-01 - 2018-09-30 |
2017-07-01 - 2017-09-30 |
2018-01-01 - 2018-09-30 |
2017-01-01 - 2017-09-30 |
2017-01-01 - 2017-12-31 |
|---|---|---|---|---|---|
| Other operating income | 7 | 73 | 146 | 135 | 218 |
| 7 | 73 | 146 | 135 | 218 | |
| Operating expenses | |||||
| Sales, general and administration expenses | -6,105 | -4,834 | -18,453 | -16,674 | -23,475 |
| Research and development expenses | -17,204 | -16,836 | -52,259 | -44,563 | -57,150 |
| Other operating expenses | -218 | 0 | -1,070 | -143 | -293 |
| Operating profit/loss | -23,520 | -21,597 | -71,637 | -61,245 | -80,700 |
| Result from financial items | |||||
| Interest income and similar items | 0 | 0 | 0 | 0 | 636 |
| Interest expense and similar items | -1 | -62 | -8 | -267 | -273 |
| Profit/loss after financial items | -23,520 | -21,659 | -71,645 | -61,512 | -80,338 |
| Total profit/loss before taxes | -23,520 | -21,659 | -71,645 | -61,512 | -80,338 |
| Income tax expense | - | - | - | - | - |
| Profit/loss for the period | -23,520 | -21,659 | -71,645 | -61,512 | -80,338 |
| Earnings/loss per share before and after dilution (SEK) |
-0,5 | -0,8 | -1,4 | -2,4 | -3,1 |
| Amounts in KSEK | 2018-07-01 - 2018-09-30 |
2017-07-01 - 2017-09-30 |
2018-01-01 - 2018-09-30 |
2017-01-01 - 2017-09-30 |
2017-01-01 - 2017-12-31 |
|---|---|---|---|---|---|
| Result for the period | -23,520 | -21,659 | -71,645 | -61,512 | -80,338 |
| Other comprehensive income | - | - | - | - | - |
| Total comprehensive result for the period | -23,520 | -21,659 | -71,645 | -61,512 | -80,338 |
| Amounts in KSEK | 2018-09-30 | 2017-09-30 | 2017-12-31 |
|---|---|---|---|
| ASSETS | |||
| Subscribed capital unpaid | 0 | 0 | 105,239 |
| Fixed assets | |||
| Tangible assets | |||
| Equipment | 23 | 87 | 69 |
| Total tangible assets | 23 | 87 | 69 |
| Financial assets | |||
| Other securities held as fixed assets | 1 | 1 | 1 |
| Total financial assets | 1 | 1 | 1 |
| Total fixed assets | 24 | 88 | 70 |
| Current assets | |||
| Current receivables | |||
| Tax credits and related receivables | 404 | 283 | 344 |
| Other receivables | 1,688 | 2,019 | 3,156 |
| Prepaid expenses and accrued income | 2,977 | 4,119 | 8,454 |
| Total current receivables | 5,069 | 6,421 | 11,954 |
| Investments | 0 | 9,527 | - |
| Cash and bank balances | 133,273 | 43,586 | 128,883 |
| Total current assets | 138,342 | 59,533 | 140,837 |
| TOTAL ASSETS | 138,367 | 59,621 | 246,146 |
| SHAREHOLDERS' EQUITY Restricted equity |
|||
| Share capital | 2,548 | 1,298 | 1,298 |
| New share issue in progress | 0 | 0 | 1,250 |
| Total restricted equity | 2,548 | 1,298 | 2,548 |
| Unrestricted equity | |||
| Share premium reserve | 418,793 | 252,535 | 418,793 |
| Retained earnings | -231,785 | -151,447 | -151,447 |
| Profit/loss for the period | -71,645 | -61,512 | -80,338 |
| Total unrestricted equity | 115,364 | 39,576 | 187,009 |
| Total shareholders' equity | 117,912 | 40,874 | 189,556 |
| LIABILITIES | |||
| LONG-TERM LIABILITIES | |||
| Other long-term liabilities | 850 | 850 | 850 |
| Total long-term liabilities | 850 | 850 | 850 |
| CURRENT LIABILITIES | |||
| Accounts payable | 5,234 | 2,623 | 11,714 |
| Other liabilities | 1,291 | 331 | 331 |
| Accrued expenses and deferred income | 13,081 | 14,944 | 43,694 |
| Total current liabilities | 19,605 | 17,897 | 55,740 |
| Total liabilities | 20,455 | 18,747 | 56,590 |
| TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES | 20,455 | 18,747 | 56,590 |
| Amounts in KSEK | Share capital | Share premium reserve | Retained earnings incl. profit/loss for the period |
Total |
|---|---|---|---|---|
| Opening shareholders' equity 01/01/2017 | 1,298 | 252,535 | -151,447 | 102,386 |
| Profit/loss for the period | -61,512 | -61,512 | ||
| Shareholders' equity 30/09/2017 | 1,298 | 252,535 | -212,959 | 40,874 |
| Opening shareholders' equity 01/01/2018 | 2,548 | 418,793 | -231,785 | 189,556 |
| Profit/loss for the period | -71,645 | -71,645 | ||
| Shareholders' equity 30/09/2018 | 2,548 | 418,793 | -303,429 | 117,912 |
| Amounts in KSEK | 2018-07-01 - 2018-09-30 |
2017-07-01 - 2017-09-30 |
2018-01-01 - 2018-09-30 |
2017-01-01 - 2017-09-30 |
2017-01-01 - 2017-12-31 |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating profit/loss before financial items | -23,520 | -21,597 | -71,637 | -61,245 | -80,700 |
| Adjustment for items not included in cash flow | 14 | 18 | 44 | 53 | 71 |
| Interest income received | 0 | 0 | 0 | 0 | 0 |
| Interest expense paid | -1 | -62 | -7 | -267 | -273 |
| Increase/decrease in other current receivables | 1,984 | 1,357 | 6,884 | 2,583 | -2,950 |
| Increase/decrease in accounts payable | 1,745 | -1,449 | -6,481 | -2,418 | 6,674 |
| Increase/decrease in other current liabilities | 3,079 | 4,114 | -29,653 | 1,981 | 30,732 |
| Cash flow from operating activities | -16,698 | -17,620 | -100,850 | -59,313 | -46,447 |
| Investment activities | |||||
| Sale of investments | 0 | 0 | 0 | 0 | 10,162 |
| Cash flow from investment activities | 0 | 0 | 0 | 0 | 10,162 |
| Financing activities | |||||
| New share issues | 0 | 0 | 105,239 | 0 | 94,761 |
| Costs attributable to the new share issues | 0 | 0 | 0 | 0 | -32,492 |
| Cash flow from financing activities | 0 | 0 | 105,239 | 0 | 62,269 |
| Cash flow for the period | -16,698 | -17,620 | 4,390 | -59,313 | 25,984 |
| Cash and cash equivalents at the beginning of the period | 149,971 | 61,206 | 128,883 | 102,899 | 102,899 |
| Cash and cash equivalents at the end of the period | 133,273 | 43,586 | 133,273 | 43,586 | 128,883 |
The Company prepares its interim reports in accordance with IAS 34 with regard to the exceptions from and additions to IFRS which are listed in RFR2 and the Swedish Annual Accounts Act. The Company is not a part of any group of companies, which is why a full IFRS reporting will not be applicable.
The accounting principles and calculation methods remain unchanged from those applied in the Annual Report for financial year 1 Jan-31 December 2017.
Disclosures in accordance with IAS 34.16A are provided both in Notes as well as elsewhere in the interim report.
IFRS 9 applies as of January 1, 2018. IFRS 9 Financial instruments addresses the classification, valuation and accounting of financial assets and liabilities. The full version of IFRS 9 was issued in July 2014 and replaces those parts of IAS 39 that addresses the classification and valuation of financial instruments. The standard includes three valuation categories for financial assets: accrued acquisition value, fair value, other comprehensive income and fair value through profit or loss. How an instrument is classified is based on the company's business model and the individual's individual characteristics. In accordance with IFRS 9, a credit loss reserve is booked based on expected losses instead of based on losses incurred. For financial liabilities, no change in classification and valuation is made except for liabilities valued at fair value through profit or loss. Changes in the value of changes in own credit risk, according to IFRS 9, are reported in other comprehensive income. The standard also implies relief of the documentation that has to be drawn up regarding hedge accounting. The company's financial instruments consist exclusively of accounts receivable and liquid assets. These will continue to be classified and valued in the category of accrued acquisition value, and the transition has thus had no effect on the company as regards the classification and valuation of financial assets. Immunicum has historically had marginal credit loan losses and IFRS 9 has, in terms of calculating the credit risk reserve, had no effect on the contents of the prepared financial statements.
IFRS 15 applies from 1 January. 2018. IFRS 15 Revenue from agreements with clients regulates revenue recognition and replaces IAS 18 Revenue, IAS 11 Entrepreneurship Agreement and associated IFRIC and SIC. IFRS 15 includes an aggregate revenue recognition model focusing on when control goes from seller to buyer rather than transition of risks and benefits. Revenue shall be reported when the customer receives control over the item or service sold and is able to use and receive the benefit from the goods or services. The standard entails increased disclosure obligations, which means that information about revenue types, timing of regulation, uncertainties linked to revenue recognition, etc. must be provided. In the development of
its products, Immunicum has not come to the stage that the business generates revenue from agreements with customers. Immunicum has made the assessment that implementation of IFRS 15 has no effect on established financial statements.
In January 2016, the IASB published the new standard for lease accounting, IFRS 16 Leases. The standard causes changes to the lessee but does not entail any material change for the lessor. The amendment compared with the current IAS 17 Leases is that all contracts in which the company is the lessee are to be handled in the same way as Financial leases have been handled in accordance with IAS 17.
The accounting is based on the view that the lessee has a right to use an asset over a specific period of time and at the same time an obligation to pay for this right, so the lessee must report a right-of-use asset and a lease liability in its balance sheet. Exceptions exist for contracts with shorter maturities than 12 months and agreements relating to assets amounting to smaller amounts. IFRS 16 clarifies that a lessee may differentiate between leasing components and service components in an agreement.
IFRS 16 Leases comes into effect for the fiscal year beginning on January 1, 2019. The company currently has no finance leases only an operating lease agreement, an office lease contract, why implementation of IFRS 16 is not expected to give rise to any significant impact on the financial statements.
None of the IFRS or IFRIC interpretations that have yet to come into legal effect are expected to have any significant impact on Immunicum.
Immunicum applies the guidelines issued by Esma for alternative performance measures. Alternative performance measures are financial measurements of historical or future earnings, financial position, financial results or cash flows that are not defined or specified in the applicable financial reporting rules and which are central to the understanding and evaluation of Immunicum's operations.
The carrying amount is assessed to be a reasonable estimate of the fair value for the financial instruments held by the Company. The Company's investments in securities are valued in accordance with the principle of lower of cost or net realizable value.
Pledged assets total KSEK 565,537 (KSEK 565,537)
Income statement
| 2017-07-01-2017-09-30 Amounts in KSEK |
Income statement classified by nature of expense |
Adjustment other external costs |
Adjustment personnel costs |
Adjustment depreciation |
Information | Income statement classified by function |
|---|---|---|---|---|---|---|
| Other operating income | 73 | 0 | 0 | 0 | 73 | |
| Operating expenses | ||||||
| Other external costs | -18,142 | 18,142 | 1 | 0 | ||
| Personnel costs | -3,511 | 3,511 | 2 | 0 | ||
| Depreciation of tangible assets | -18 | 18 | 0 | |||
| Sales, general and administration expenses |
-3,094 | -1,733 | -7 | -4,834 | ||
| Research and development expenses |
-15,048 | -1,777 | -11 | -16,836 | ||
| Other operating expenses | 0 | |||||
| Operating profit/loss | -21,597 | 0 | 0 | 0 | -21,597 | |
| RESULT FROM FINANCIAL ITEMS | ||||||
| Interest income and similar items | 0 | 0 | ||||
| Interest expense and similar items |
-62 | -62 | ||||
| Profit/loss after financial items | -21,659 | -21,659 | ||||
| Total profit/loss before taxes | -21,659 | -21,659 | ||||
| Income tax expense | - | - | ||||
| Profit/loss for the period | -21,659 | -21,659 |
| 2017-01-01-2017-09-30 Amounts in KSEK |
Income statement classified by nature of expense |
Adjustment other external costs |
Adjustment personnel costs |
Adjustment depreciation |
Information | Income statement classified by function |
|---|---|---|---|---|---|---|
| Other operating income | 135 | 0 | 0 | 0 | 135 | |
| Operating expenses | ||||||
| Other external costs | -49,043 | 49,043 | 1 | 0 | ||
| Personnel costs | -12,141 | 12,141 | 2 | 0 | ||
| Depreciation of tangible assets | -53 | 53 | 0 | |||
| Sales, general and administration expenses |
-11,097 | -5,557 | -21 | -16,674 | ||
| Research and development expenses |
-37,945 | -6,584 | -33 | -44,563 | ||
| Other operating expenses | -143 | |||||
| Operating profit/loss | -61,245 | 0 | 0 | 0 | -61,245 | |
| RESULT FROM FINANCIAL ITEMS | ||||||
| Interest income and similar items | 0 | 0 | ||||
| Interest expense and similar items |
-267 | -267 | ||||
| Profit/loss after financial items | -61,512 | -61,512 | ||||
| Total profit/loss before taxes | -61,512 | -61,512 | ||||
| Income tax expense | - | - | ||||
| Profit/loss for the period | -61,512 | -61,512 |
1. Other external costs have been allocated to administrative expenses and research and development costs. Since Immunicum's research and development is conducted by external parties, these costs have previously been recorded as external costs. External costs booked as administration costs consist of legal costs, marketing costs, board fees, audit fees and other overhead costs.
2. Personnel expenses have been allocated according to the function of each employee. 4 people on administrative expenses and 7 people on research and development costs.
Allocation of depreciation of tangible assets
| Amounts in KSEK | 18-07-01 -18-09-30 |
17-07-01 - 17-09-30 |
18-01-01 -18-09-30 |
17-01-01 - 17-09-30 |
|---|---|---|---|---|
| Administration expenses | 5 | 7 | 17 | 20 |
| Research and development expenses | 9 | 11 | 27 | 33 |
| Total | 14 | 18 | 44 | 53 |
The report has been translated from Swedish. The Swedish text shall govern for all purposes and prevail in the event of any discrepancy between the versions.
This report has been reviewed by the company's auditors.
Carlos de Sousa, CEO, Immunicum Telephone: +46 (0) 31 41 50 52 E-mail: [email protected]
Michaela Gertz, CFO, Immunicum Telephone: +46 (0) 31 41 50 52 E-mail: [email protected]
Address Grafiska vägen 2 SE-412 63 Gothenburg Telephone +46 31-41 50 52 e-mail [email protected] Website www.immunicum.com Organisation number: 556629-1786
This information is the information that the Company is obligated to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on 7 November at 08:00, via the above contact person.
To the Board of Directors of Immunicum AB
Corp. id. 556629-1786
We have reviewed the attached condensed interim report of Immunicum AB as of 30 September 2018 and the threemonth 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 Annual Accounts Act. Our responsibility is to express a conclusion on this financial information (interim report) based on our review.
We conducted our review in accordance with International Standard on Review Engagements ISRE 2410 Review of Interim Financial Information Performed by the Independent Auditor of the Entity. A review of interim financial information 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 practices and consequently does 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 attached interim report is not prepared, in all material respects, in accordance with the Annual Accounts Act.
Göteborg 7 November 2018
KPMG AB
Jan Malm
Authorized Public Accountant
Grafiska vägen 2 412 63 Göteborg Tel: 031- 41 50 52
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