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2016-11-18

Immunicum: Quarterly report July 2016 - September 2016

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
1stof July to end of June - to follow the calendar year as well as to shorten
the current fiscal year to cover the period 1stof July 2016 up to and
including 31stof 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

Immunicum Q1 16
http://hugin.info/171739/R/2057734/771117.pdf

---------------------------------------
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Immunicum AB via Globenewswire

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