7 November 2018
Immunicum AB (publ) Interim Report July - September 2018
Positive preclinical results presented at ESMO
Significant Events During the Third Quarter
- Immunicum announced protocol approval by the FDA enabling the initiation of expanded multi-indication phase Ib/II combination trial.
- Immunicum announced appointment of Pawel Kalinski and Inge Marie Svane to Scientific Advisory Board.
Significant Events During Jan - Sept
- Patient recruitment was completed in the ongoing, global Phase II MERECA (MEtasatic REnal Cell CArcinoma) clinical trial. The objective of the study is to provide proof of concept for ilixadencel through the achievement of multiple endpoints indicative of meaningful clinical impact and safety assessed over an 18-month period.
- Immunicum announced ATMP (Advanced Therapy Medicinal Product) Certificate Granted by the European Medicines Agency to ilixadencel for manufacturing quality and nonclinical data.
- Immunicum announced the trading of its shares (IMMU.ST) on the main market of Nasdaq Stockholm.
- Immunicum presented a case study of one patient from the Phase I/II HCC trial at the Cholangiocarcinoma Foundation Annual Conference in Salt Lake City, Utah.
- Immunicum announced publication of scientific review of ilixadencel approach in Pharmaceutical Research.
- Immunicum announced end of enrollment in Phase I/II GIST clinical trial.
- Michaela Gertz joined the company as Chief Financial Officer.
- Michael Oredsson was elected as new Chairman of the Board and the board members Magnus Nilsson, Magnus Persson, Steven Glazer, Charlotte Edenius and Kerstin Valinder Strinnholm were re-elected as board members.
Significant Events After End of Period
- Immunicum announced a proposed capital raise of SEK 351M in a Directed Issue and a fully guaranteed Rights Issue for continued clinical development of ilixadencel and calls for an extraordinary general meeting on the 8th of November.
- Immunicum presented preclinical results of ilixadencel in combination with checkpoint inhibitors and immune enhancers at ESMO 2018.
|Q3||Jan - Sept||Full year|
|KSEK unless otherwise stated||2018||2017||2018||2017||2017|
|Earnings per share, before and after dilution (SEK)||-0.5||-0.8||-1.4||-2,4||-3.1|
|Number of employees||11||10||11||10||11|
CEO Comment - Third quarter
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 forthe 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
The full quarterly report is available on:
The information is such information that Immunicum is obliged to make public pursuant to EU Market Abuse Regulation. The information was released for public disclosure through the contact persons detailed below on 7 November 2018 at 8.00 am CET.
For more information, please contact:
Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
Michaela Gertz, CFO, Immunicum
Telephone: +46 70 926 17 75
Gretchen Schweitzer and Joanne Tudorica
Telephone: +49 172 861 8540
| 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|