15 February 2019
Validations from different corners of the industry
| Q4 | Full year | ||
| KSEK unless otherwise stated | 2018 | 2017 | 2018 |
| Operating profit/loss | -26,209 | -19,455 | -97,846 |
| Net profit/loss | -26,215 | -18,826 | -97,860 |
| Earnings per share, before and after dilution (SEK) | -0.5 | -0.7 | -1.9 |
| Cash | 443,798 | 128,883 | 443,798 |
| Shareholders equity | 406,041 | 189,556 | 406,041 |
| Number of employees | 11 | 12 | 12 |
2018 stands as a successful year for Immunicum; a year in which the Company achieved key milestones within the organization and prepared itself for an active 2019 in which we face several essential value inflection points. Through the completion of a noteworthy financing round, the establishment of our first collaboration with two major pharmaceutical companies as well as external validation of our lead candidate ilixadencel, we have successfully secured our foundation within the immuno-oncology space. We now look forward to taking Immunicum to the next level of clinical and corporate development in 2019.
During the last 12 months, Immunicum focused on the advancement of our clinical pipeline and enabling the continued exploration of the potential within our lead drug candidate, ilixadencel. On the clinical side, we achieved important milestones including completion of recruitment for patients in the Phase II MERECA trial and the Phase I/II GIST trial as well as receiving approval from the FDA for the Phase Ib/II ILIAD clinical trial protocol. Within the medical and scientific community we gained external validation through publications of clinical and preclinical results in peer-reviewed journals and at global scientific conferences.
On the corporate side, we signed a collaboration with global pharmaceutical leaders, Pfizer and Merck KGaA, that will allow us to further explore ilixadencel's potential as a backbone component to various cancer combination treatments. In addition, we secured longterm financing through a Rights Issue and Directed Issue with a set of renowned institutional owners, including Gladiator, Fourth AP-fund, the Second AP-fund, Alfred Berg, Nordic Cross and Adrigo. This funding will allow us to invest in the continued development and supportive preclinical validation of ilixadencel. Furthermore, it will enable us to develop full scale production capabilities so that we are prepared to manufacture at commercial scale for future pivotal studies and potential commercial launch. Importantly, we will be financed up until the end of 2021 which will provide us with the stability needed to meet our development goals and pursue strategic opportunities from a position of strength.
As we look towards the coming year, we see several significant clinical milestones on the horizon. One of the highlights will be the results from the global Phase II MERECA study which are expected to be announced in the third quarter of 2019. This Phase II study evaluates ilixadencel in combination with the standard-of-care treatment sunitinib, a kinase inhibitor, in newly-diagnosed patients with metastatic renal cell carcinoma. The topline results from this study will bring us additional insight into the safety and potential for clinical efficacy of ilixadencel.
We are also pleased to have announced the enrollment of the first patient in the multi-indication Phase Ib/II ILIAD study which will evaluate ilixadencel as an immune primer in combination with checkpoint inhibitors in head and neck cancer, non-small cell lung cancer and gastric and gastroesophageal junction adenocarcinoma. This trial will remain a high priority for the Company as it will efficiently explore ilixadencel's initial efficacy in a variety of solid tumors in combination with checkpoint inhibitors as well as provide further results on its safety in patients. We expect to present initial data in the second half of 2019.
Lastly, in mid-2019, we expect results from the Phase I/II study in gastrointestinal stromal tumors (GIST) clinical trial. The main purpose of the study is to examine whether ilixadencel is safe and tolerable for those patients. Objective response and progression free survival will also be evaluated.
In summary, the advancements and achievements made in 2018 give us confidence as we enter into 2019. With our corporate and clinical strategies in place, we look forward to continue to bring value to our shareholders and advance our vision of improving cancer therapy for patients.
Carlos de Sousa
President and CEO
The full quarterly report is available on:
http://immunicum.se/investors/financial-reports/
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 February 15 2019, at 8.00 CET.
Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
E-mail: info@immunicum.com
Michaela Gertz, CFO, Immunicum
Telephone: +46 70 926 17 75
E-mail: ir@immunicum.com
Gretchen Schweitzer and Joanne Tudorica
Trophic Communications
Telephone: +49 172 861 8540
E-mail: ir@immunicum.com
About Immunicum AB (publ)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. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq Stockholm. www.immunicum.com |