Quarterly Report • Feb 18, 2020
Quarterly Report
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» Immunicum Presented Updated Data from Phase II MERECA Trial of Ilixadencel in Kidney Cancer at ASCO-SITC Clinical Immuno-Oncology Symposium. December 2019 data showed a separation in survival curves in favor of the ilixadencel group
| Q4 | Q4 | Full year | Full year | |
|---|---|---|---|---|
| KSEK unless otherwise stated | 2019 | 2018 | 2019 | 2018 |
| Operating profit/loss | -40,052 | -26,209 | -132,324 | -97,846 |
| Net profit/loss | -42,012 | -26,215 | -134,016 | -97,860 |
| Earnings per share, before and after dilution (SEK) | -0.5 | -0.5 | -1.5 | -1.9 |
| Cash | 296,811 | 443,798 | 296,811 | 443,798 |
| Shareholders equity | 272,781 | 406,041 | 272,781 | 406,041 |
| Number of employees | 11 | 11 | 11 | 11 |
Fourth quarter
» 2019 was an important year for Immunicum. The results from the MERECA and GIST studies show clear and promising clinical results for ilixadencel in combination with tyrosine kinase inhibitors* while maintaining ilixadencel's favorable safety and tolerability profile.
The GIST study indicates that ilixadencel has the potential to overcome resistance to tyrosine kinase inhibitors. In two of the patients who showed tumor progression during the ongoing treatment with tyrosine kinase inhibitors, a long-term stable disease was observed with ilixadencel treatment, despite the fact that patients were allowed to continue with the same tyrosine kinase inhibitor that they received before the ilixadencel treatment was initiated. In addition, in these two patients, a transient period was noted when the tumor showed a partial response.
During the fall, we reported the results of the MERECA study, as per data cut-off in July 2019, which showed a higher proportion of patients surviving with metastatic renal cell carcinoma treated with ilixadencel in combination with sunitinib compared to the control group who was treated with sunitinib alone. The ilixadencel treated patients also showed a more durable tumor response. At the recently completed ASCO-SITC Immuno-Oncology symposium in Orlando, USA, a follow-up of the patients in the study made in December 2019 was presented by one of the study's principal investigator,
associate professor Magnus Lindskog, chief physician at the oncology clinic at Uppsala Academic Hospital. The follow-up shows a separation between the survival curves in favor of the ilixadencel group. In addition, a so-called post hoc analysis of confirmed tumor response (a tumor response remaining at the next subsequent CT-scan performed at least 4 weeks later) showed a significant difference between the groups; 42.2% in the ilixadencel group compared to 24% in the control group treated with sunitinib alone. However, none of the groups have yet achieved their final median overall survival.
Presenting both the MERECA and the GIST study at the ASCO-SITC symposium is indeed a significant recognition of our work which has led to an increased interest in the international scientific and medical community.
We have also provided an initial update on safety and tolerability in the first three patients treated with ilixadencel in combination with the checkpoint inhibitor* Keytruda® (pembrolizumab) in the ILIAD study. The results showed a favorable safety profile without any serious side
* treatments that fight immune suppression
effects in these patients. We expect to be able to report the next security update towards the end of the second quarter of this year. If the safety profile remains positive, we will be able to include patients to the study in a non-staggered manner, rather than incrementally, which significantly will increase the inclusion rate.
In October 2019, we were able to report the results of a study in the preclinical field that investigated ilixadencel in combination with the checkpoint inhibitor anti-CTLA-4. In this study, tumor bearing mice treated with mouse ilixadencel in combination with anti-CTLA-4 antibodies exhibited a stronger tumor response compared to the control group treated with the clinically established combination of anti-PD-1 and anti-CTLA-4 antibodies. Anti-CTLA-4 in combination with anti-PD-1 is an effective immunotherapy for the treatment of melanoma and has also shown good results in other indications, including metastatic renal cell carcinoma. In addition to combinations with ilixadencel and tyrosine kinase inhibitors, we work to identify effective combinations with other immunotherapies without adding unacceptable side effects. This is particularly interesting in indications where the first generation of checkpoint inhibitors has a limited efficacy, for example, non-small cell lung cancer, head and neck cancer and stomach cancer.
The data we have presented about ilixadencel during the year, especially the results of the MERECA study, reinforces our view that our lead candidate has the potential to play both a clinical and a market role in the future. The results give us several opportunities for further clinical development. We are now assessing how we can develop ilixadencel in the most optimal way to offer patients a significantly better treatment.
If 2019 has been a year in which our belief in ilixadencel was strengthened by the study results, it has also been a challenging year by other means. For me personally, it was initially an unfamiliar situation to assume the new role of acting CEO, but the routines have now started to settle. I will also continue to focus on our research in my role as Chief Scientific Officer, but take on the role as acting CEO with great enthusiasm. Not least thanks to the strong and competent team at Immunicum. I will continue as acting CEO until we have a new permanent CEO in place, which is something that the Board is actively working to resolve.
We will keep the market up to date as important decisions are made and we look forward to continuing our efforts to develop ilixadencel and improve treatment for cancer patients and thereby create value for the shareholders.
ALEX KARLSSON-PARRA Acting CEO
» Immunicum is a biopharmaceutical company that develops immune therapies against a range of solid tumors. Immunicum is establishing a unique immuno-oncology approach through the development of allogeneic, off-the-shelf cell-based therapies. Our goal is to improve survival outcomes and quality of life by priming the patient's own immune system to fight cancer. The company's lead product ilixadencel, consisting of pro-inflammatory allogeneic dendritic cells, has the potential to become a backbone component of modern cancer combination treatments in a variety of solid tumor indications. Immunicum has evaluated ilixadencel in several clinical trials including the recently completed exploratory Phase II MERECA study in kidney cancer. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq Stockholm Small Cap.
The Company's lead product, ilixadencel, has been developed to be able to take advantage of each patient's unique profile of tumor-specific antigens by injecting ilixadencel directly into the tumor. This approach thereby eliminates the need to characterize, select and produce each patient´s tumor-specific antigens before treatment.
» induction of local tumor cell death leading to increased release of tumor-specific antigens and maturation of antigen-loaded dendritic cells for subsequent migration to tumor-draining lymph nodes where the dendritic cells activate/prime tumor-specific T cells
II. ilixadencel is applicable for all injectable solid tumors
Immunicum's strategy is to position ilixadencel as the first choice of cancer immune primers that are to be combined with treatments that fight immune suppression e.g. checkpoint inhibitors and certain tyrosine kinase inhibitors. This is for the patient to have a stronger immune response with a more effective anti-tumor treatment.
The ILIAD study is a multi-indication, open-label, randomized multicenter, Phase Ib/II trial that evaluates the safety and efficacy of intratumorally administered ilixadencel in combination with a checkpoint inhibitor at standard doses in the selected indications. The Phase Ib part of the study is ongoing in the US and the first patient was treated in February 2019. During this part ilixadencel will be combined with Keytruda® (pembrolizumab).
In the Phase Ib part of the trial 21 patients are enrolled with the aim to assess safety and define the optimal dose and schedule of ilixadencel administration in combination with Keytruda® (pembrolizumab). Ilixadencel showed a favorable safety profile with no serious adverse events in combination with Keytruda® in the first three patients that were dosed with two intratumoral injections of 3 million cells. Treatment is now underway in the second cohort and safety assessment is expected to take place at the end of the second quarter of this year.
The Phase II part of the trial will group patients by indication (HNSCC, NSCLC and GA) into three studies advancing in parallel. The aim of the Phase II study is to demonstrate a favorable impact of ilixadencel used in combination with checkpoint inhibitor therapy. Each indication group will include enough patients to observe statistically significant clinical activity for the combination group.
In November 2018, Immunicum announced a collaboration with Merck KGAa and Pfizer for the evaluation of ilixadencel in combination with the checkpoint inhibitor avelumab (Bavencio®) in the Phase II portion of ILIAD. The safety and efficacy of ilixadencel in combination with avelumab will be evaluated in patients with head and neck cancer and gastric cancer. Immunicum will be fully responsible for the study and retains all commercial rights to ilixadencel.
In August 2019, Immunicum completed an exploratory, international, randomized, controlled and open-label Phase II clinical trial (MERECA) in which a total of 88 newly diagnosed, intermediate and high risk metastatic renal cancer patients were enrolled. Fifty-six patients received treatment with ilixadencel followed by nephrectomy (the removal of the tumor affected kidney) and standard treatment with the tyrosine kinase inhibitor Sutent® (sunitinib). Thirty patients included in the control group underwent only nephrectomy and standard treatment with Sutent®.
The primary objectives of the study were to evaluate median overall survival (OS) and 18-month survival rates. Secondary objectives included evaluation of safety and tolerability, tumor response and immunological profiling including T cell infiltration.
As of July 2019, 57% (32 out of 56 patients) in the ilixadencel treatment group were alive compared with 43% (13 out of 30 patients) in the control group. The final value for the median Overall Survival could not be calculated in either group as the data was not mature enough. Based on Kaplan-Meier probabilities, the 18-month OS rate was 63% in the ilixadencel combination group and 66% in the sunitinib monotherapy group.
In December 2019 follow up data on survival showed a separation in survival curves in favor of the ilixadencel group, while final median Overall Survival (OS) values were still not reached in either of the two study groups.
Survival as of December 2019 was 54% (30 of 56) in the ilixadencel treatment group compared with 37% (11 of 30) of patients in the control group treated with sunitinib monotherapy.
The Objective Response Rate (ORR) is the proportion of patients with Complete Responses (CR) or Partial Responses (PR), measured by CT scan within the 18-month follow-up. The best ORR was similar in the two groups with 44% (20 out of 45 patients) in the ilixadencel combination group and 48% (12 out of 25 patients) in the sunitinib monotherapy group. However, the number of Complete Responders was higher in the ilixadencel combination group with 11% (5 out of 45 patients) compared to 4% (1 out of 25 patients) in the sunitinib monotherapy group. Furthermore, the ilixadencel combination group showed a longer median Duration of Response (7.1 months versus 2.9 months in the sunitinib monotherapy group) within the 18-months follow-up and a higher percentage of responses ongoing at the 18- months follow-up, 60% (12 out of 20 patients) versus 33% (4 out of 12 patients) in the sunitinib monotherapy group.
Based on these data on best overall response and the Duration of Response, a post-study analysis was performed by the contract research organization of confirmed ORR (a tumor response that is confirmed by a follow-up scan, per RECIST 1.1 criteria). The confirmed ORR for the ilixadencel treatment group was 42.2 % (19/45) versus 24.0% (6/25) for the sunitinib control group.
All Complete Responders in the ilixadencel combination group were still alive at last patient contact (5 out of 5 CRs), while the Complete Responder in the sunitinib monotherapy group had died.
Tumor tissue from the surgically removed kidney tumors was available from post-ilixadencel treatment patients and non-treatment control patients. Analysis of the tissue showed a median stained area of 1.08% in the ilixadencel group as compared to 0.84% in the untreated control group, at time of kidney surgery. The high variability of CD8-stained area in the tumors within the treatment groups, between different samples taken from the same tumor and also within Complete Responders, indicate that the intratumor infiltration of CD8+ T cells by itself, without
| Ilixadencel-sunitinib | Sunitinib | |
|---|---|---|
| ORR (Best Overall Response) | 44 % (n=20/45) | 48 % (n=12/25) |
| - Complete Response | 11 %* (n=5/45) | 4,0 % (n=1/25) |
| - Partial Response | 33 % (n=15/45) | 44 % (n=11/25) |
| Confirmed ORR | 42 % (n=19/45) | 24 % (n=6/25) |
| - Complete Response | 6,7 % (n=3/45) | 0 % (n=0/25) |
| - Partial Response | 36 % (n=16/45) | 24 % (n=6/25) |
* Two pts with CR had CR as best response at last available CT scan (at 10 mo and 18 mo respectively)
Median duration of response was 7.1 mo (ilixadencel-sunitinib) vs 2.9 mo (sunitinib)
considering CD8+ T cell specificity and functionality, does not explain the systemic therapeutic impact of ilixadencel when combined with sunitinib.
The overall safety and tolerability data was similar in both treatment groups, meaning that the addition of ilixadencel to sunitinib did not add toxicity. This confirms ilixadencel's favorable safety profile from previous studies and supports that ilixadencel is well-suited for combination therapies. These results indicate that ilixadencel provided a systemic therapeutic benefit while maintaining a positive safety and tolerability profile. Overall the data supports the continued clinical development of ilixadencel as an immune primer in RCC and other solid tumors.
In 2014 Immunicum presented the results from a Phase I/ II study in twelve patients with newly diagnosed metastatic renal cell carcinoma (mRCC). No treatment-related serious adverse events have been noted. The median overall survival time for the patient group as a whole was 48 months compared to the expected median survival time of 14 – 16 months for standard treatment with Sutent® (sunitinib).
Immunicum completed a Phase I/II clinical trial with ilixadencel concerning the treatment of patients with GIST in June 2019. Six patients were enrolled and treated with ilixadencel in combination with Sutent® (sunitinib), Stivarga® (regorafenib) or similar tyrosine kinase inhibitor (targeted therapy). Ilixadencel met the primary endpoint of safety, with no life-threatening treatment-related adverse events and no signs of autoimmunity. The secondary endpoint of efficacy was primarily evaluated based on tumor growth. The most positive outcome was seen in two patients where tumor growth halted and partially regressed for three and six months, respectively. These partial responses indicate that ilixadencel had a therapeutic impact by overcoming resistance to TKIs in these two patients with metastatic disease whose disease previously progressed on secondand/or third-line TKI treatment.
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). Only 1 out of 18 patients experienced grade 3 treatment-related adverse event, as compared to approx. 1 in 3 patients described in literature for standard of care sorafenib or regorafenib. 11 out of 15 evaluable patients exhibited an increase in, tumor-specific CD8 T-cell in peripheral blood. Overall survival ranged from 1.6 - 21.4 months in the total group of 17 HCC patients.
Immunicum has performed preclinical studies in a mouse tumor model where cancer cells (CT26 colon carcinoma) are injected subcutaneously followed by treatment with checkpoint inhibitors (anti-PD1) and immune enhancers (anti-4-1BB/CD137). These two classes in the immunooncology field block the tumor's defenses against the activated immune system 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. Ilixadencel showed synergy in reducing tumor growth and increasing survival in combination with both classes, further positioning our strategy for ilixadencel as a key component in future combination therapies for solid tumors.
In addition, recently conducted preclinical studies in the same animal model show that animals that were treated with the combination of ilixadencel and CTLA-4 showed a stronger anti-tumor response as compared to animals treated with anti-PD-1 and anti-CTLA-4, a well-known combination of checkpoint inhibitors (CPIs).
Immunicum intends to conduct further preclinical studies with ilixadencel to investigate further combinations.
IMM-2 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 transfected with an adenoviral vector to deliver tumor antigens directly to the cells. These cells are then injected subcutaneously (under the skin) as opposed to ilixadencel's intratumoral injection. 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.
The European Patent Office recently decided to grant a new Immunicum patent. The patent is based on a method in which the allogeneic dendritic cells (ilixadencel) are infected with an adenovirus carrying genes encoding tumor antigen, including mutation-derived neoantigen and tumor-associated virus antigen (oncoviral antigen). The method enables subcutaneous administration of this ilixadencel based immune primer instead of intratumoral administration.
Immunicum's IMM-3 platform 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. Immunicum's goal is to explore development opportunities for the IMM-3 concept and collaboration opportunities with CAR-T or similar technologies, upon which the platform would be dependent for further development.
According to Radiant Insights, the market for immune therapies is expected to grow at an annual growth rate of 23.9 percent, and amount to USD 75.8 billion by 2022.
Immunotherapeutic drugs have the potential to change the therapeutic landscape in the treatment of cancer. Immuno-oncology, Immunicum's focus area, is a relatively new and rapidly growing part of the market and there is considerable room for new players to take market shares and high potential for products that are based on new technology and potentially offer minor or no side effects.
Within immuno-oncology there are two categories of drugs that are designed to attack the cancer in two different ways:
Immunicum's objective is to position ilixadencel as the backbone drug in combination treatments for activating the immune system (immune primers).
Anti-immunosuppression is the more developed field within immuno-oncology where the majority of all large pharmaceutical companies currently operate. Pioneers in this field are Bristol-Myers Squibb's Opdivo® and MSD's Keytruda®. These therapies are checkpoint inhibitors that block an immune pathway on T cells that the tumor can exploit to suppress the immune system.
In immune activation, there are various approaches and Immunicum operates within the class of immune primers that is used for intratumoral administration and utilizes the patient's own tumor as the neoantigen source in situ. This part of the immune primer landscape is where both Immunicum's ilixadencel and immune enhancers such as Toll Like Receptors (TLR)- and STING-ligands as well as oncolytic viruses operate. The strength with Immunicum's immune primer ilixadencel is that it engages the entire immune system activation process needed instead of addressing parts like the above-mentioned methods.
No revenue was reported for the quarter or full year (-). Other operating income amounted to KSEK 727 (38) for the quarter and to KSEK 893 (184) for the full year and consisted of exchange rate gains on accounts payable.
Total operating expenses for the quarter amounted to KSEK 40,780 (26,247) and for the full year to KSEK 133,217 (98,030).
Research and development costs for the quarter amounted to KSEK 30,444 (18,671) and for the full year to KSEK 103,144 (70,930). The cost increase is mainly explained by CMC and the increased development costs related to the process development activities to strengthen the manufacturing process of ilixadencel. The costs are also explained by increased activities in ongoing clinical and preclinical studies.
During the quarter, administrative expenses amounted to KSEK 9,212 (7,161) and to KSEK 28,498 (25,614) for the full year. The costs are attributable to the organization and the company's intensified level of business activity.
Operating profit for the quarter was KSEK -40,052 (-26,209) and for the full year KSEK -132,324 (-97,846). The result for the quarter amounted to KSEK -42,012 (-26,215) and to KSEK -134,016 (-97,860) for the full year. Earnings per share before and after dilution amounted to SEK -0.5 (-0.5) for the quarter and to SEK -1.5 (-1.9) for the full year.
No tax was reported for the quarter or the full year (-).
Cash flow from operating activities for the quarter amounted to KSEK -35,314 (-3,819) and for the full year to KSEK -145,808 (-104,670). The continued negative cash flow is according to plan and is explained by the company's increased clinical activities as well as process development for manufacturing of ilixadencel. Cash flow from operating activities for the full year is also affected by paid account payables for the share issue conducted in December 2018.
During the quarter cash flow from investing activities amounted to KSEK 0 (0). During the year cash flow from investing activities amounted to KSEK -251 (0) and is an asset reclassification from current assets to financial assets.
Cash flow from financing activities for the quarter amounted to KSEK 0 (314,344). Cash flow from financing activities for the full year amounted to KSEK 756 (419,583) which is related to warrant premiums from the incentive program that was initiated in May. The company's cash and cash equivalents on December 31, 2019 amounted to KSEK 296,811 (443,798). Total equity as of December 31, 2019 amounted to KSEK 272,781 (406,041), which corresponds to SEK 2.95 (5.65) per share. The company's equity ratio at the end of the year was 90% (90%).
All operations are conducted in one company and there is therefore no group.
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 co-workers 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 Shareholder's General Meeting in April 2019, a new 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. Full utilization of granted options corresponding to 2,178,089 shares will result in a dilution for shareholders of 2,3 percent.
Immunicum has chosen to conduct its business operations with a minimal number of employees on staff supplemented by consultants, in order to maintain flexibility and cost effectiveness. As of December 31, 2019, the Company had 11 (11) direct employees, of whom 7 (6) were women and 4 (5) 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 December 31, 2019 amounted to 92,257,531 (71 874 119) and the share capital in the company amounted to SEK 4,612,876.55. All shares have equal voting right and share of Immunicum's assets and profit.
The annual report will be published the first week of April 2020. The AGM will be held in Stockholm on April 28, 2020. Shareholders who wishes to have a matter addressed at the general meeting 2020 shall have submitted a written request to the board of directors not later than seven weeks prior to the date of the annual general meeting. The request shall be sent to: Immunicum AB (publ), Board of directors, Östermalmstorg 5, 114 42 Stockholm
| Owners | IMMU | Capital/Votes |
|---|---|---|
| Avanza Pension | 8,234,047 | 8,9 % |
| Fourth Swedish National Pension Fund | 7,000,000 | 7,6 % |
| Nordnet Pension Insurance | 4,640,380 | 5,0 % |
| Loggen invest AB | 3,240,000 | 3,5 % |
| Holger Blomstrand Byggnads AB | 2,975,386 | 3,2 % |
| BNP Paribas Sec Serv Luxembourg | 957,450 | 1,0 % |
| Alfred Berg Funds | 956,293 | 1,0 % |
| Göran Källebo | 931,863 | 1,0 % |
| Elivågor AB | 875,000 | 0,9 % |
| The Bank of New York Mellon SA/NV | 873,836 | 0,9 % |
| SEB Funds | 857,300 | 0,9 % |
| Ivar Nordqvist | 775,716 | 0,8 % |
| Other | 59,940,260 | 65,0 % |
| Total | 92,257,531 | 100.0 % |
The Board of Directors propose that no dividend will be paid for the financial year 2019.
This report has not been reviewed by the company's auditor.
Stockholm February 18, 2020 Immunicum AB (publ)
Michael Oredsson CHAIRMAN OF THE BOARD Steven Glazer BOARD MEMBER
Magnus Persson BOARD MEMBER Charlotte Edenius BOARD MEMBER
Kerstin Valinder Strinnholm BOARD MEMBER
Alex Karlsson-Parra CEO
| 2019 | 2018 | 2019 | 2018 | |
|---|---|---|---|---|
| Amounts in KSEK | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| Other operating income | 727 | 38 | 893 | 184 |
| 727 | 38 | 893 | 184 | |
| OPERATING EXPENSES | ||||
| Sales, general and administration expenses | -9,212 | -7,161 | -28,498 | -25,614 |
| Research and development expenses | -30,444 | -18,671 | -103,144 | -70,930 |
| Other operating expenses | -1,124 | -415 | -1,576 | -1,485 |
| Operating profit/loss | -40,052 | -26,209 | -132,324 | -97,846 |
| RESULT FROM FINANCIAL ITEMS | ||||
| Net financial items | -1,960 | -, | -1,692 | -14 |
| Profit/loss after financial items | -42,012 | -26,209 | -134,016 | -97,860 |
| TOTAL PROFIT/LOSS BEFORE TAXES | -42,012 | -26,209 | -134,016 | -97,860 |
| Income tax expense | - | - | - | - |
| PROFIT/LOSS FOR THE PERIOD | -42,012 | -26,215 | -134,016 | -97,860 |
| Earnings/loss per share before and after dilution (SEK) | -0.5 | -0.5 | -1.5 | -1.9 |
| 2019 | 2018 | 2019 | 2018 | |
|---|---|---|---|---|
| Amounts in KSEK | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| Result for the period | -42,012 | -26,215 | -134,016 | -97,860 |
| Other comprehensive income | - | - | - | - |
| Total comprehensive result for the period | -42,012 | -26,215 | -134,016 | -97,860 |
| Amounts in KSEK | 2019-12-31 | 2018-12-31 |
|---|---|---|
| ASSETS | ||
| Fixed assets | ||
| Tangible assets | ||
| Equipment | - | 9 |
| Total tangible assets | - | 9 |
| Financial assets | ||
| Other securities held as fixed assets | 1 | 1 |
| Other long term receivables | 251 | - |
| Total financial assets | 252 | 1 |
| Total fixed assets | 252 | 10 |
| Current assets | ||
| Inventories | - | 1,469 |
| Current receivables | ||
| Other receivables | 2,983 | 3,307 |
| Prepaid expenses and accrued income | 3,783 | 1,788 |
| Total current receivables | 6,766 | 5,095 |
| Cash and bank balances | 296,811 | 443,798 |
| Total current assets | 303,577 | 450,363 |
| TOTAL ASSETS | 303,829 | 450,373 |
| SHAREHOLDERS' EQUITY | ||
| Restricted equity | ||
| Share capital | 4,613 | 3,594 |
| New share issue in progress | - | 1,019 |
| Total restricted equity | 4,613 | 4,613 |
| Unrestricted equity | ||
| Share premium reserve | 731,828 | 731,073 |
| Retained earnings | -329,645 | -231,785 |
| Profit/loss for the period | -134,016 | -97,860 |
| Total unrestricted equity | 268,168 | 401,428 |
| Total shareholders' equity | 272,781 | 406,041 |
| LIABILITIES | ||
| LONG-TERM LIABILITIES | ||
| Other long-term liabilities | 850 | 850 |
| Total long-term liabilities | 850 | 850 |
| CURRENT LIABILITIES | ||
| Accounts payable | 12,819 | 31,266 |
| Other liabilities | 1,644 | 838 |
| Accrued expenses and deferred income | 15,736 | 11,378 |
| Total current liabilities | 30,199 | 43,482 |
| Total liabilities | 31,049 | 44,332 |
| TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES | 303,829 | 450,373 |
| 2019 | 2018 | 2019 | 2018 | |
|---|---|---|---|---|
| Amounts in KSEK | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| Operating activities | ||||
| Operating profit/loss before financial items | -40,052 | -26,209 | -132,324 | -97,846 |
| Adjustment for items not included in cash flow | 0 | 14 | 9 | 58 |
| Interest income received | 10 | - | 10 | - |
| Interest expense paid | -7 | -7 | -17 | -14 |
| Increase/decrease in other current receivables | -2,231 | -1,495 | -202 | 5,389 |
| Increase/decrease in accounts payable | 2,720 | 26,033 | -18,447 | 19,552 |
| Increase/decrease in other current liabilities | 4,247 | -2,155 | 5,164 | -31,807 |
| Cash flow from operating activities | -35,314 | -3,819 | -145,808 | -104,668 |
| Investment activities | ||||
| Investment in financial assets | - | - | -251 | - |
| Cash flow from investing activities | - | - | -251 | - |
| Financing activities | ||||
| New share issues | - | 351,042 | - | 456,281 |
| Premiums for warrants | - | - | 756 | - |
| Costs attributable to the new share issues | - | -36,697 | - | -36,697 |
| Cash flow from financing activities | - | 314,344 | 756 | 419,583 |
| Cash and cash equivalents at the | ||||
| beginning of the period | 334,088 | 133,273 | 443,798 | 128,883 |
| Cash flow for the period | -35,314 | 310,526 | -145,303 | 314,915 |
| Foreign echange difference in cash and cash equivalents |
-1,963 | - | -1,684 | - |
| Cash and cash equivalents at the end of the period | 296,811 | 443,798 | 296,811 | 443,798 |
| Amounts in KSEK | Share capital | Share premium reserve | Retained earnings incl. profit/loss for the period |
Total |
|---|---|---|---|---|
| Opening shareholders' equity 01/01/2019 | 4 613 | 731 073 | -329 645 | 406 041 |
| Profit/loss for the period | -134 016 | -134 016 | ||
| Comprehensive result for the period | -134 016 | -134 016 | ||
| Transactions with owners | ||||
| Premiums for warrants | 756 | 756 | ||
| Total transaction with owners | 756 | 756 | ||
| Shareholders' equity 31/12/2019 | 4 613 | 731 828 | -463 660 | 272 781 |
| Opening shareholders' equity 01/01/2018 | 2 548 | 418 793 | -231 785 | 189 556 |
| Profit/loss for the period | -97 860 | -97 860 | ||
| Comprehensive result for the period | -97 860 | -97 860 | ||
| Transactions with owners | ||||
| Share issue | 2 065 | 348 977 | 351 042 | |
| Costs for new share issue | -36 697 | -36 697 | ||
| Total transaction with owners | -36 697 | -36 697 | ||
| Shareholders' equity 31/12/2018 | 4 613 | 731 073 | -329 645 | 406 041 |
This report covers the Swedish company Immunicum AB (publ), 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 interim report for the fourth quarter 2019 was approved for publication on February 18, 2020.
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. Immunicum's business currently consists of research and development for production of pharmaceuticals. The company is of the opinion that this business, in its entirety, constitutes a single operating segment. The accounting principles and calculation methods remain unchanged from those applied in the Annual Report for financial year 1 Jan-31 December 2018. Disclosures in accordance with IAS 34.16A are provided both in Notes as well as elsewhere in the interim report.
From January 2019 the new standard IFRS 16 applies. 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 company applies the simplification rule in RFR 2 and will continue to report leasing costs linearly over the lease term.
None of the IFRS or IFRIC interpretations that have yet to come into legal effect are expected to have any significant impact on Immunicum.
Pledged assets total KSEK 251 (566).
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 Annual Report 2018 which can be downloaded from the Company's website: www.immunicum.com.
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 Immunicums results.
Margareth Jorvid, Head of Regulatory Affairs and Quality System, and member of Immunicum's management team has during the quarter invoiced Immunicum KSEK 413 in consultancy fees through the company Methra in Uppsala AB.
Immunicums financial assets and liabilities comprise of cash and cash equivalents, pledged assets, other current assets, accrued expenses and accounts payable. The fair value of all financial instruments is materially equal to their carrying amounts.
Immunicum presented data from the MERECA during an oral presentation at ASCO-SITC Clinical Immuno-Oncology Symposium in Orlando, Florida.
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 abovementioned performance measure is not always defined in the same manner, and other companies may calculate the differently to Immunicum.
| Oct-Dec 2019 | Oct-Dec 2018 | Jan- Dec 2019 | Jan-Dec 2018 | |
|---|---|---|---|---|
| Total registered shares at the beginning of period | 92,257,531 | 50,958,431 | 71,874,119 | 25,958,541 |
| Total registered shares at the end of period | 92,257,531 | 71,874,119 | 92,257,531 | 71,874,119 |
| Share capital at the end of period, SEK | 4,612,877 | 3,593,706 | 4,612,877 | 3,593,706 |
| Equity at the end of period, SEK thousand | 272,781 | 406,041 | 272,781 | 406,041 |
| Earnings per share before and after dilution, SEK | -0.5 | -0.5 | -1.5 | -1.9 |
| Research and development costs, SEK thousand | 30,444 | 18,671 | 103,144 | 70,930 |
| Research & development costs/operating expenses % | 75 % | 71 % | 77 % | 72 % |
| Alternative performance measurements | Definition | Justification |
|---|---|---|
| Equity ratio | Total shareholders' equity divided by total assets |
The Company believes that this key ratio provides investors with useful information of the Company's capital structure. |
| Research & development costs/operating expenses % |
Research and development costs divided by total operating expenses |
The company believes that 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. |
| Oct-Dec 2019 | Oct-Dec 2018 | Jan- Dec 2019 | Jan-Dec 2018 | |
|---|---|---|---|---|
| Equity ratio at the end of the period % | ||||
| Total shareholders' equity at the end of the period (KSEK) | 272,781 | 406,041 | 272,781 | 406,041 |
| Total assets at the end of the period (KSEK) | 303,829 | 450,373 | 303,829 | 450,373 |
| Equity ratio at the end of the period % | 90 % | 90 % | 90 % | 90 % |
| Research & development costs/operating expenses % | ||||
| Research & development costs | 30,444 | 18,671 | 103,144 | 70,930 |
| Administrative costs | 9,212 | 7,161 | 28,498 | 25,614 |
| Other operating expenses | 1,124 | 415 | 1,576 | 1,485 |
| Total operating expenses | 40,780 | 26,246 | 133,217 | 98,029 |
| Research & development costs/operating expenses % | 75 % | 71 % | 77 % | 72 % |
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.
| Annual general meeting 2020: | 28 April 2020 |
|---|---|
| Interim report Q1 2020: | 28 April 2020 |
| Interim report Q2 2020: | 27 August 2020 |
| Interim report Q3 2020: | 5 November 2020 |
| Year-End report 2020: | 18 February 2021 |
E-mail: [email protected]
Michaela Gertz, CFO, Immunicum Telephone: +46 (0)8 732 8400 E-mail: [email protected]
Postal address: Östermalmstorg 5 114 42 Stockholm Website www.immunicum.se Corporate identity number 556629-1786
The information was submitted for publication, through the agency of the contact persons set out above, on February 18, 2020, at 8:00 CET.
Immunicum AB
Östermalmstorg 5 114 42 Stockholm
Phone: +46 (0)8 732 8400
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