27 August 2020
Immunicum AB (publ) Interim Report January – June 2020
April – June in Summary
- Net sales for the period amounted to KSEK – (-).
- Result for the period amounted to KSEK -26,412 (-33,220)
- Earnings and diluted earnings per share totaled SEK -0.29 (-0.36).
- Immunicum received Regenerative Medicine Advanced Therapy the (RMAT) Designation from the FDA for ilixadencel in kidney cancer.
- Immunicum appointed Peter Hein as interim Chief Financial Officer.
- Immunicum announced advancement to a non-staggered inclusion phase in the Phase Ib/II ILIAD combination trial.
- Immunicum announced publication of Phase I/II clinical trial results of ilixadencel in Gastrointestinal Stromal Tumors (GIST) in Cancer Immunology, Immunotherapy.
- To date, Immunicum has not experienced any major impact to its operations owing to the COVID-19 pandemic but it is a risk that the recruitment of patients to the ongoing ILIAD trial will be delayed since it’s currently not possible to include additional sites in the study. For further information, go to the risk section on page 17.
Significant Events After End of Period
- Immunicum announced an update on survival data from the Phase II MERECA trial of ilixadencel in kidney cancer. August 2020 data showed that the median Overall Survival (OS) was reached at 25 months in the control group treated with sunitinib, while the final median OS in the ilixadencel treatment group has not yet been reached.
Financial Summary in Summary
|Apr – Jun||Jan – Jun||Full year|
|KSEK unless otherwise stated||2020||2019||2020||2019||2019|
|Earnings per share, before and after dilution (SEK)||-0.29||-0.36||-0.63||-0.68||-1.46|
|Number of employees||11||11||11||11||11|
CEO Comment – First quarter
Our efforts during the second quarter of 2020 have been focused on key regulatory interactions, the continuation of the ongoing Phase Ib/II ILIAD combination trial, as well as strategic preparations to advance our off-the-shelf immune primer, ilixadencel.
First and foremost, receiving the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for ilixadencel in kidney cancer was an important milestone for the Company. The FDA’s decision was based on the previously communicated results from the Phase II MERECA clinical trial that evaluated the safety and efficacy of ilixadencel in combination with Sutent® (sunitinib) in patients with newly diagnosed metastatic renal cell carcinoma (mRCC). As such, receiving the RMAT designation recognizes both the potential of our novel therapeutic approach as well as the clear need for viable therapies to address this difficult-to treat disease.
Furthermore, one of the most important benefits of the designation is that we gain access to an increased number of interactions with the FDA and meetings earlier in the process, which can speed up drug development and review. In addition, the RMAT status allows us to ensure at an earlier stage that ilixadencel meets the FDA’s standard, which reduces the risks in the development program. In doing so, the RMAT also strengthens the chances of final market approval. Importantly, the FDA has confirmed that the RMAT designation is not limited to the combination of ilixadencel with sunitinib,but supports the development of ilixadencel in kidney cancer more broadly.
We recently announced an update on survival from the MERECA trial. The new set of data confirmed that the final median Overall Survival (OS) for the sunitinib control group had been reached at 25.3 months. Meanwhile, the median OS has not yet been reached in the ilixadencel treatment group, indicating a survival benefit in the study’s co-primary endpoint. In addition, all five Complete Responders (CRs) in the ilixadencel treatment group were still alive in this follow-up, while the one CR in the control group died during the first follow-up period. The next follow-up on survival data will be announced during the first quarter of 2021. With each round of follow-up, we have the opportunity to gain additional insight on the potential efficacy of ilixadencel in combination with standard-of-care in patients with metastatic tumors, which enables us to better determine the next set of priorities and objectives for our lead candidate.
During the first half of the year we also provided an update on the ongoing Phase Ib/II ILIAD combination trial evaluating ilixadencel in combination with the checkpoint inhibitor (CPI), Keytruda® (pembrolizumab). Based on the confirmation from the Dose Escalation Committee, there were no dose-limiting toxicities, therefore the study can move into the non-staggered inclusion phase. The Phase Ib portion of the trial includes 21 patients and the non-staggered phase will enable the remaining 15 patients to proceed more rapidly as there will no longer be a need for a safety evaluation period between every individual patient enrolled. However, our ability to further accelerate enrollment with additional clinical centers may be impacted by the Covid-19 pandemic. Based on this, we expect the next safety update by the end of this year and the completion of the Phase Ib including longer follow-up for potential signs of efficacy towards the second half of 2021.
In June 2020, the scientific journal Cancer Immunology, Immunotherapy published the final data analysis from the clinical study of ilixadencel in patients with Gastrointestinal Stromal Tumors (GIST) providing further validation of ilixadencel. GIST is a rare and difficult-to-treat disease and the trial showed that ilixadencel in combination with different tyrosine kinase inhibitors (TKIs) had a favorable safety profile and provided initial signals of clinical benefit, with two out of six patients showing tumor shrinkage despite previous tumor progression on the same TKI.
During the second quarter of this year, we welcomed Peter Hein to the team as Interim CFO. Peter’s background in life science and finance has facilitated a smooth transition for the Company and we look forward to continuing to work with him. As the Phase II MERECA data continue to mature and bring insight into the potential long-term survival benefits of ilixadencel in combination with Sutent®, our advancements in terms of regulatory feedback and RMAT designation can now also be presented to industry leaders.
Financially we stand on solid ground. Our cash position on June 30 was SEK 232 million and with our current financial commitments, this is sufficient to finance the Company until the end of 2021.
In summary, we have reached significant milestones in 2020 that build long-term value for the Company and our shareholders. Immunicum remains well-positioned to continue validating and advancing ilixadencel with the ultimate goal of benefiting patients with difficult-to-treat solid tumors.
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 August 27, 2020, at 8:00 am CET.
For more information, please contact:
Alex Karlsson-Parra, CSO and Interim CEO, Immunicum
Telephone: +46 8 732 8400
E-mail: [email protected]
|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. Immunicum has evaluated ilixadencel in several clinical trials including the recently completed exploratory Phase II MERECA study in kidney cancer and the Company is moving towards late-stage clinical development. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq Stockholm. www.immunicum.com