18 August 2017
Immunicum AB: Interim Report Q2 – Corporate Update and Outlook
Immunicum AB (publ; First North Premier: IMMU.ST) a biopharmaceutical company advancing an off-the-shelf immune system primer against a range of solid tumors, today announced its financial results and a corporate update for the second quarter 2017.
CEO Statement – Second quarter
Over the second quarter, Immunicum has advanced on several fronts that will be critical for positioning Immunicum and our allogeneic cell-based cancer therapy ilixadencel for success. Furthermore, I am very pleased that we have completed our internal strategic analysis on the next phase of ilixadencel’s clinical development program. We have designed it with a clear focus to increase the number of key value inflection points and expand the indications and regulatory opportunities for the product in the evolving cancer therapeutic landscape. Based on applicability in a variety of solid tumors, its potential synergistic effects with other cancer therapies such as PD-1/PD-L1 inhibitors and its encouraging safety profile, we have now defined our vision to increase the program’s value. A more in-depth discussion of the plan is included in the second quarter report and as the next step, we are currently considering different funding options to enable the implementation of the plan.
Immunicum’s progress in the second quarter also includes the continued advancement of our ongoing clinical studies in renal cell carcinoma, HCC and GIST. In the ongoing Phase II MERECA study, in renal cell carcinoma a total of 68 patients at 28 centers in eight European countries and the US have been enrolled so far. The enrollment of the first patient in the United States is an important achievement for us. Although the process has been slower than anticipated, the current expectation is that we will complete the enrollment for the MERECA trial in the second half of this year. Two additional important highlights of the past quarter also include the publication in the Journal for ImmunoTherapy of Cancer of the complete results of ilixadencel’s first clinical trial in metastatic Renal Cell Carcinoma (mRCC) and approval of the International Nonproprietary Name (INN), ilixadencel, for our lead program INTUVAX®. The described progress is a testament to the commitment of the Immunicum team to bring this therapy to patients and deliver long-term value to our shareholders.
We remain, as always, committed to our shareholders as we open the next chapter in Immunicum’s corporate development efforts to harness ilixadencel’s full potential. Over the past year, we have seen strong progress in our clinical development programs, which make us confident that we have chosen the right direction for ilixadencel. These are truly exciting times for me as a CEO and the whole team at Immunicum as we position the company into a path of measurable success in the clinic and for patients. I look forward to providing regular updates on our plans and achievements in the coming months.
Carlos de Sousa
President and CEO
Significant events during the second quarter
The Company received approval of the International Nonproprietary Name (INN), ilixadencel, for the Company’s lead program INTUVAX®, a cancer immune primer designed to specifically reactivate the patient’s immune system to recognize and destroy tumor cells. The INN system has been established to facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients in a unique and globally recognized manner. Ilixadencel was the chosen nonproprietary, or “generic” name selected by the World Health Organization (WHO) through their close collaboration with the Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations.
Publication in Journal for ImmunoTherapy of Cancer of results overview from the first-in-human study with ilixadencel in patients with newly diagnosed metastatic renal cell carcinoma (mRCC). The results highlight ilixadencel’s potential as a novel anti-cancer immune primer for patients suffering from solid tumors based on its good safety profile and initial indications of prolonged survival.
Significant events after end of period
The first patient was enrolled in the United States (US) as part of the Company’s ongoing global Phase 2 MERECA (MEtastatic REnal Cell CArcinoma) trial. This continues the expansion of Immunicum’s clinical program to realize ilixadencel’s potential and to execute a global clinical trial including meeting all regulatory and manufacturing requirements in the US which are significant for a cell-based therapy.
The Company announced the last patient last visit in the ongoing Phase I/II study of ilixadencel in hepatocellular carcinoma (HCC). The open label study enrolled eighteen patients and was conducted at the Sahlgrenska University Hospital at Gothenburg University. Topline results from the study following data analysis are anticipated before the end of the year.
Immunicum’s leadership team, together with its Board of Directors completed an internal strategic review process to define the next phase of ilixadencel’s clinical development program. The review process was initiated in the beginning of 2017 to evaluate the current therapeutic landscape and ensure that the Company’s clinical development efforts are positioned to realize ilixadencel’s full potential
Financial Summary Second Quarter in Brief
Second quarter (April to June) 2017 Compared with the Same period in 2016
Operating loss amounted to TSEK -19,115 (-15,068 TSEK)
Net loss amounted to TSEK -19,124 (-15,018 TSEK)
Earnings per share before and after dilution amounted to SEK -0.74 (SEK -0.74)
FInancial Summary January-June 2017
The operating loss amounted to TSEK -39,648 (TSEK -24,596)
Net loss amounted to TSEK -39,853 (TSEK -24,629)
Earnings per share before and after dilution amounted to SEK -1.54 (SEK -1.22)
Cash and Cash equivalents plus funds invested in mutual fund amounted to TSEK 70,732 as of June 30, 2017 (TSEK 129,442)
Shareholders’ equity per share amounted to SEK 2.41 (SEK 5.36)
Number of employees at the end of the period was 10 (8)
The full quarterly report is available on:
For more information, please contact:
Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
Investor Relations Sweden
Hallvarsson & Halvarsson
Telephone: + 46 709 71 12 53
Investor and Media Relations EU/US
The Company’s Certified Adviser is Redeye AB
Telephone: +46 (0) 8 545 013 31
The information is such information that Immunicum is obliged to make public pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the company’s contact person on August 18, 2017 at 08.00 CET.
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 First North Premier. www.immunicum.com