5 November 2020
Immunicum AB (publ) Interim Report January – September 2020
July – September in Summary
- Net sales for the period amounted to KSEK – (-).
- Result for the period amounted to KSEK -22,244 (-29,643).
- Earnings and diluted earnings per share totaled SEK -0.24 (-0.32).
- Immunicum presented updated corporate and clinical development strategy.
- Immunicum presented preclinical data supporting the combination of ilixadencel with cancer therapies and immunotherapies including anti-VEGF, anti-PD1 and anti-CTLA4 at the 2020 Virtual ESMO Congress.
- Immunicum announced the appointment of Sven Rohmann as Chief Executive Officer.
- Immunicum announced update on survival data in Phase II MERECA trial evaluating ilixadencel in combination with Sutent® (sunitinib).
- 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 12.
Significant Events After End of Period
- On October 6, 2020, 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 (DEC) confirmed there were no dose limiting toxicities.
|Jul – Sep||Jan – Sep||Full year|
|KSEK unless otherwise stated||2020||2019||2020||2019||2019|
|Earnings per share, before and after dilution (SEK)||-0.24||-0.32||-0.87||-1.00||-1.46|
|Number of employees||10||12||11||11||11|
CEO Comment – Third Quarter
It is a great pleasure to join Immunicum at this exciting stage of its corporate development and with the clinical progress the Company has achieved with ilixadencel, our off-the-shelf immune primer. Based on the encouraging clinical proof-of-concept through anti-tumor response and indications of survival benefits provided by the MERECA study as well as the growing body of clinical and pre-clinical data, we remain convinced of ilixadencel’s ability to enable more durable and stronger anti-tumor responses in combination with standard treatment regimens, and its potential to transform modern cancer immunotherapy.
Based on my commercial experience, I am confident that we can execute on this potential when we now enter late-stage development for ilixadencel. I would also like to take this opportunity to thank Immunicum’s investors for the warm welcome at my arrival.
Since my start at the Company in August of this year, we have put great effort in clearly defining the long-term objectives for Immunicum and evaluating how we can rapidly provide ilixadencel to patients. Resulting from this effort, we announced our updated corporate and clinical development strategy at the end of the third quarter. The key takeaway is that Immunicum is now in the right position to start operating with a commercial focus, while taking steps to establish the Company as a cell therapy powerhouse. We have the financial resources available to achieve key objectives in the implementation of the strategy. We will also look into possibilities to expand our internal pipeline. Our corporate and clinical development strategy is built on four core pillars of
GIST/Sarcoma as Orphan Indications – for rare diseases with major medical needs
To accelerate ilixadencel’s development towards market approval, we prioritize the evaluation of ilixadencel in the orphan indications gastrointestinal stromal tumors (GIST)
Phase Ib/II ILIAD Trial – Novel Indications and Ongoing Combination
We are currently evaluating ilixadencel in combination with checkpoint inhibitors in the ILIAD Phase Ib/II trial in novel solid tumor indications. After the completion of the Phase Ib part evaluating ilixadencel in combination with Keytruda® (pembrolizumab) towards the second half of 2021, we will be able to identify the most relevant indications and potential Pharma partners to move this combination forward.
Renal Cell Carcinoma (Kidney Cancer) – Proven Indication, Novel Combination
The recent shift in current standard of care and our promising preclinical data combining ilixadencel with anti-PD1 and anti-CTLA4, supported our decision to add ilixadencel to the established combination treatment regimen of anti-CTLA4 (ipilimumab) and anti-PD1 (nivolumab) to treat renal cell carcinoma. We are preparing a clinical study to confirm the safety and potential efficacy of our novel approach.
Pipeline Expansion – Identifying Next-Generation Cell Therapies
Additionally, we will build upon the mode-of-action and clinical proof-of-concept of ilixadencel, as well as continue to seek potentially synergistic cell therapies, to expand our internal pipeline.
In summary, our objective is to meet the needs of patients by advancing ilixadencel as a novel therapy option as swiftly as possible. I believe that this approach, based on the four pillars of opportunity, enables an accelerated pathway toward our goal. In parallel, being able to efficiently execute on our stated plans will maximize value for our shareholders and we look forward to keeping you informed on our progress as we advance our clinical development for ilixadencel.
Chief Executive Officer
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 November 5, 2020, at 8:00 am CET.
For more information, please contact:
Sijme Zeilemaker, COO, Immunicum
Telephone: +46 8 732 8400
|About Immunicum AB (publ) Immunicum will become a cell therapy powerhouse in immuno-oncology by demonstrating the therapeutic value of its off-the-shelf immune primer, ilixadencel, in a broad range of solid tumor indications. Ilixadencel has achieved clinical proof-of-concept in a Phase II study, which showed its ability to provide a more durable and deeper anti-tumor response, resulting in longer-term survival. The Company is evaluating ilixadencel in a total of six cancer indications with the potential to address both large and orphan populations. By combining ilixadencel with modern immunotherapies and standard-of-care, it is Immunicum’s goal to improve treatment outcomes and quality of life for cancer patients. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq Stockholm. www.immunicum.com|