Immunicum AB (publ) Year-End Report 2019

Press Release

18 February 2020

Immunicum AB (publ) Year-End Report 2019

October – December in Summary

• Net sales for the period amounted to KSEK - (-).
• Result for the quarter amounted to KSEK -42,012 (-26,215).
• Earnings and diluted earnings per share totaled SEK -0.5 (-0.5)
• Immunicum AB (publ) Announced Upcoming Oral Presentation on MERECA Trial at the ASCO-SITC Clinical Immuno-Oncology Symposium.
• Immunicum AB (publ) Announced Resignation of Carlos de Sousa as CEO and Alex Karlsson-Parra was appointed interim CEO.
• Immunicum AB Announced Advancement to Next Dosage Group Level in Phase Ib/II ILIAD Combination Trial.
• Immunicum AB Announced Positive Preclinical Data on Ilixadencel in Combination with CTLA-4 Immune Checkpoint Inhibitor.
• The European Patent Office decided to grant the new Immunicum patent ”Improved allogeneic dendritic cells for use in cancer treatment”.

January – December in Summary

• Immunicum announced the topline data from the exploratory Phase II MERECA clinical trial. Five patients had complete responses and the topline data on survival benefit in all patients showed that a higher percentage of ilixadencel patients were alive as per data cut-off in July 2019.
• Immunicum announced positive topline results from its completed Phase I/II clinical trial examining the safety and tolerability of Immunicum’s lead candidate, ilixadencel, in combination with tyrosine kinase inhibitors (TKIs) in six patients with Gastrointestinal Stromal Tumors (GIST), a rare and difficult-to-treat disease indication.
• At the AGM a long-term incentive program for all employees was approved. The program was subscribed to 94,4 %.

Significant Events After End of Period

•  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.
  
    

Financial Summary

CEO Comment - Fourth quarter – Year End        

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 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

The full quarterly report is available on:

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, 2020, at 8:00 am CET.

For more information, please contact:

Alex Karlsson-Parra, CSO and Interim CEO, Immunicum

Telephone:

E-mail:   

Michaela Gertz, CFO, Immunicum

Telephone:

E-mail:   

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