Immunicum AB (publ) Announces Year-End Results 2020
18 February 2021
Immunicum AB (publ) Announces Year-End Results 2020
OCTOBER-DECEMBER IN SUMMARY
- Net sales for the period amounted to KSEK – (-)*.
- Result for the period amounted to KSEK -47,568 (19,409)*.
- Earnings and diluted earnings per share totaled SEK -0.57 (-0.26)*.
- Immunicum announced the last safety and enrollment update for the ongoing Phase Ib/II ILIAD combination trial. As of October 6, 15 patients were enrolled in the study and ilixadencel maintained a favorable safety profile. The Dose Escalation Committee confirmed there were no dose limiting toxicities. Immunicum received Orphan Drug Designation from the US Food and Drug Administration (FDA) for ilixadencel in Hepatocellular Carcinoma (HCC).
- Board member Magnus Persson left the Board in October.
- On November 18, Immunicum announced that the Company had entered into a binding agreement with Van Herk Investments BV to acquire all shares in DCprime BV to establish a leader in cell-based cancer immunotherapies. At the Extraordinary General Meeting on December 18, the Board’s resolution on a directed new issue of shares to Van Herk Investments BV with payment in capital contributed in kind consisting of all shares in DCprime BV was approved. The transaction was completed on December 21*.
- Immunicum received FDA Fast Track Designation for ilixadencel for the treatment of the orphan indication Gastrointestinal Stromal Tumors (GIST).
- Immunicum announced the completion of patient recruitment for Phase Ib portion of ILIAD combination clinical trial.
- Immunicum received FDA Orphan Drug Designation for ilixadencel as a treatment for liver cancer, specifically Hepatocellular Carcinoma (HCC).
- To date, Immunicum has not experienced any major impact to its operations owing to the Covid-19 pandemic. For further information, go to the risk section on page 21 in the full report.
SIGNIFICANT EVENTS AFTER END OF PERIOD
- Prior to the EGM on January 22, 2021, Chairman Michael Oredsson announced his resignation from the Board, whereby the Board appointed the current Board member Christine Lind as interim Chairman until the Annual General Meeting on May 4, 2021. At the EGM, Dharminder Chahal and Andrea van Elsas, Ph.D., nominated by the Company’s largest owner Van Herk Investments, were elected new members of the Board.
- Immunicum received FDA Orphan Drug Designation for Ilixadencel as a treatment of Soft Tissue Sarcoma (STS), which includes GIST.
- Immunicum announced plans to expand its research and process development facilities in Leiden, the Netherlands.
- Immunicum appointed Lotta Ferm as interim Chief Financial Officer.
|KSEK unless otherwise stated||2020||2019||2020||2019|
|Earnings/loss per share, before and after dilution (SEK)||-0.57||-0.26||-1.17||-0.65|
|Number of employees at the end of the period||29||30||29||30|
CEO COMMENT - FOURTH QUARTER
2020 was the year in which Immunicum’s efforts to secure advantageous regulatory conditions for the further clinical development of ilixadencel were rewarded. The designations awarded by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) strengthen our hope that our novel immunotherapy ilixadencel based on the Company’s proprietary, ground-breaking research will advance rapidly and provide further clinical evidence that ilixadencel may improve survival outcomes and quality of life for cancer patients.
In the year 2020, the US FDA granted Immunicum Regenerative Medicine Advanced Therapy (RMAT) designation in kidney cancer (RCC) and Fast Track Designation (FTD) for ilixadencel in the orphan indication Gastrointestinal Stromal Tumors (GIST). In addition, the US FDA awarded Orphan Drug Designation for ilixadencel in Hepatocellular Carcinoma (HCC).
Furthermore, ilixadencel has progressed according to plan in the ongoing clinical trials. In December, we successfully finished patient recruitment for the Phase Ib portion of the ILIAD trial. The completion of this milestone brings us one step closer to the topline data readout that is expected in Q3 2021, which will give us further insight on the potential of ilixadencel in a range of indications.
In the fourth quarter, we announced that Immunicum had joined forces with DCprime, a Dutch clinical stage company developing cancer relapse vaccines based on allogeneic dendritic cell biology. DCprime is complementary and synergistic to Immunicum’s approach. The combination of the two companies expands our pipeline, creates a broader range of therapeutic options and enhances the platform with which to establish Immunicum as a leading cell therapy company.
DCprime has communicated encouraging clinical results on its lead candidate DCP-001 in blood-borne tumors, including interim data from its ongoing Phase II study in Acute Myeloid Leukemia (AML), which was presented at an oral presentation at the ASH 2020 Conference in December 2020.
Immunicum will now advance a synergistic pipeline spanning both large and orphan indications in solid as well as blood-borne tumors, with two clinical lead programs, ilixadencel and DCP-001, in Phase II clinical development. Beyond the Phase II candidates, our Company has a broad portfolio of late-stage preclinical candidates. The new research and process development facility in Leiden, The Netherlands, will allow for further pipeline expansion upon completion of the move in 2022.
Based on my industry experience, I am convinced that the combination of process development, manufacturing and specialized in-house research and development expertise in the new Immunicum will support our goal of becoming a leader in cell-based immunotherapies. The increased control over all development processes in drug development is critical for Immunicum to establish itself as a fully integrated biotechnology company.
I would like to welcome Erik Manting, Ph.D., Chief Business Officer & Deputy CEO, and Jeroen Rovers, M.D., Ph.D., Managing Director of DCprime to the Immunicum team. Both joined Immunicum from DCprime following the completion of the business combination. As a new team, we are all dedicated to ensuring that our programs with complementary therapeutic approaches, based on intratumoral priming and cancer relapse vaccination, currently in Phase II clinical development, continue to move towards commercialization. We look forward to keeping you informed on our progress as we advance our program candidates.
SVEN ROHMANN, M.D., Ph.D.
Chief Executive Officer
The year-end 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 below, on February 18, 2021, at 8:00 am CET.
FOR MORE INFORMATION, PLEASE CONTACT:
Sven Rohmann, M.D., Ph.D., CEO
Telephone: +46 8 732 8400
Jonas Rodny and Carolin Wiken
Paues Åberg Communications
Telephone: +46 76 190 90 51
Eva Mulder and Sophia Hergenhan, Ph.D.
Telephone: +49 172 861 8540
ABOUT IMMUNICUM (PUBL)
Immunicum is leveraging its unparalleled expertise in dendritic cell biology to develop novel, off-the-shelf, cell-based therapies for solid and blood-borne tumors. With complementary therapeutic approaches in Phase II clinical development that are based on intratumoral priming and cancer relapse vaccination, the company aims to improve survival outcomes and quality of life for a broad population of cancer patients. Based in Sweden and the Netherlands, Immunicum is publicly traded on the Nasdaq Stockholm. www.immunicum.com
*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 thus only consist of DCprime BV until the time of acquisition, December 21, 2020. This consolidated financial statement is Immunicum’s first consolidated financial statement which has been prepared in accordance with IFRS, for further information see Note 2.1 and Note 8 in the full report.