Continued improvement in survival data both in kidney cancer and liver cancer. Enrolment process for the ongoing MERECA phase II study now implemented across Europe.
First quarter in brief
Business highlights
> Two patent applications that relate to the Company's CD70-technology in important future markets - China and the USA - approved during the first quarter.
> Immunicum's first Chief Medical Officer (CMO), Peter Suenaert, M.D., Ph.D, appointed in July.
> An Investigational New Drug (IND) application was submitted to the Food and Drug Administration (FDA) late July for approval to treat kidney cancer patients in the U.S. with INTUVAX, in Immunicum's ongoing MERECA phase II trial.
> Continued improvement in phase I/II survival data for eleven INTUVAX-treated patients with metastatic kidney cancer was presented in September. The data showed an ongoing, more than doubled median overall survival for the entire patient group and an ongoing more than tripled median overall survival for patients with poor prognosis.
> Late September, Immunicum announced the appointment of Carlos de Sousa, M.D., EMBA, as new CEO to take the company to its next stage of development.
Significant events after end of period
> At the Annual General Meeting on October 26, 2016, Steven Glazer, Charlotte Edenius and Kerstin Valinder Strinnholm were elected as new Board members.
> At the SITC annual meeting, November 14, 2016, Immunicum AB presented updated data on INTUVAX HCC phase I/II clinical study and announced last patient included in study extension.
Financial summary
> Operating profit/loss amounted to TSEK -12 018 (TSEK -7 820)
> Net profit/loss amounted to TSEK -11 985 (TSEK -7 816)
> Earnings per share before and after dilution (weighted average) amounted to SEK -0.46 (SEK -0,39)
> Bank balances and short-term investment amounted to TSEK 129 032 (TSEK 61 441) at 30 September 2016
> Shareholders' equity per share amounted to SEK 4.90 (SEK 2.84)
> Number of employees at the end of the period 9 (6)
CEO Statement - first quarter
As new CEO of Immunicum it gives me great pleasure to summarize where our operations stand today, how they have developed the past quarter and how we perceive the possibilities and challenges lying ahead.
Let me begin with a status update on the clinical trials with our unique cancer immune primer INTUVAX for the treatment of kidney and liver cancer as well as GIST (gastrointestinal stromal tumor).
Renal Cell Carcinoma (RCC ) - The enrolment process for the ongoing MERECA phase II study, where patients with newly diagnosed metastatic renal cell carcinoma are treated with INTUVAX in combination with sunitinib, is now implemented across Europe. To date, a total of 36 patients have been enrolled at 18 centers in seven European countries, with the majority of them happening in the last 6 months. I am glad to confirm that the initial challenges that caused delays in recruitment of patients outside of Sweden - the transfer of production to a large manufacturing facility in Germany, the development of a product that is more convenient for hospitals to manage and the lengthy evaluation process by the authorities of our applications in several European countries due to the innovative nature of INTUVAX - are now behind us and we also continue to expand the network of centers included in the study. Since July, Immunicum's Development team has been strengthened with three additional colleagues including the Chief Medical Officer.
Immunicum has also submitted an Investigational New Drug (IND) application to the FDA requesting approval to treat kidney cancer patients in the U.S. with INTUVAX, as part of the MERECA trial. In such a process, it is not uncommon that the FDA comes back with questions which companies need to respond to. We are currently in such stage of receiving and answering questions, meaning that the evaluation process is ongoing. We will announce when this process has been completed.
Follow-up data in September from the completed clinical phase I/II study that preceded the MERECA study shows an ongoing median overall survival of 40 months for the entire patient population, comparing very favourably to the expected 15.2 months based on historical data for standard treatment in patients with newly diagnosed metastatic renal cell carcinoma.
Hepatocellular Carcinoma (HCC) - Updated immunological and survival data from our clinical phase I/II study in patients with advanced hepatocellular carcinoma was presented at the Society for Immunotherapy of Cancer's annual meeting. The data showed that 67% of fully treated patients with advanced HCC experienced increases in circulating tumor-specific CD8+ T cells. These increases appear to correlate with the prolonged survival rates seen in the study as compared to historical median overall survival rates. In the extension of the study, we have now enrolled the last of the six additional liver cancer patients that receive INTUVAX concomitantly with first line standard of care medication.
GastroIntestinal Stromal Tumors (GIST) - As previously reported, the first patient has been included in our clinical phase I/II study with INTUVAX in patients with GIST. Due to the nature and the rarity of the disease, recruitment is slower than initially expected. We are therefore in the process of reviewing the study protocol, in collaboration with the investigators at the Karolinska Institute, with the objective of expediting enrolment.
Furthermore, we are assessing the possibility of expanding of the development plan with additional phase I/II studies in different indications, like melanoma, and in different combinations, e.g. with immune checkpoint inhibitors.
Immunicum focuses on the clinical studies with INTUVAX, but we also see very promising potential in our two other platform technologies, CD70 and the adenovirus vector, where the development is conducted in collaboration with professor Magnus Essand at Uppsala University. For CD70, we are currently evaluating the possibilities for clinical production and for the vector, we are currently conducting preclinical studies within the concept of SUBCUVAX.
In order to make it possible to broaden our shareholder base and to facilitate the company's future financing, we have applied for listing of the Immunicum share on Nasdaq Stockholm's main list. We hope that this can be realized in early 2017. Another step to ensure flexibility in the company's future funding was taken when the AGM in October authorized the Board of Directors with a mandate to resolve on new share issues of a maximum of 5,040,000 shares.
The AGM further decided to change Immunicum's fiscal year - from its present 1 st of July to end of June - to follow the calendar year as well as to shorten the current fiscal year to cover the period 1 st of July 2016 up to and including 31 st of December 2016. Our next financial report will thus be a Year End Report for that period.
We have also taken the decision to give general updates on our activities, including clinical trials, in a more organized and coherent manner, meaning that we will give regular updates twice a year, beginning fiscal year 2017 in connection with the Q2 and Year End Reports. All reporting that is significant to our milestones and/or could affect, or could be perceived to affect, our share price will of course be done immediately, just as before.
Last but not least, let me conclude by stating that after my initial period at the helm, I realize that Immunicum is even more exciting than I expected. We are now in important stages in our clinical trials with INTUVAX and we hold high hopes on the clinical data we generate going forward. Expectations are high and so is our commitment to deliver.
Carlos de Sousa President and CEO
The full quarterly report is available on: http://immunicum.se/investors/financial-reports /
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 November 18, 2016 at 08.30 CET.
For more information, please contact Carlos de Sousa, CEO, Immunicum Ph: +46 (0) 31 41 50 52 E-mail: carlos.desousa@immunicum.com
About Immunicum AB (publ) Immunicum AB (publ) develops cancer immune primers for the treatment of tumor diseases. A phase II clinical trial for the company's most advanced product - INTUVAX® against kidney cancer - has been initiated. The project portfolio contains additional clinical phase I/II studies in liver cancer and in gastrointestinal stromal tumors (GIST). Immunicum is listed on First North Premier. www.immunicum.com
The company's Certified Adviser is Redeye AB Ph: + 46 8 545 013 31 www.redeye.se
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