Immunicum AB (publ): Interim Report Q2 - Corporate Update and Outlook
August 18 2017 - 02:00AM
Press Release
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:
http://immunicum.se/investors/financial-reports/
For more information, please contact:
Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
E-mail: info@immunicum.com
Investor Relations Sweden
Helena Stångberg
Hallvarsson & Halvarsson
Telephone: + 46 709 71 12 53
E-mail: helena.stangberg@halvarsson.se
Investor and Media Relations EU/US
MacDougall Biomedical Communications
Gretchen Schweitzer or Stephanie May
Telephone: +49 89 2424 3494 or + 49 175 571 1562
E-mail: gschweitzer@macbiocom.com or smay@macbiocom.com
The Company's Certified Adviser is Redeye
AB
Telephone: +46 (0) 8 545 013 31
www.redeye.se
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
|
Q2 2017 Eng Final
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
Immunomedics (NASDAQ:IMMU)
Historical Stock Chart
From Feb 2024 to Mar 2024
Immunomedics (NASDAQ:IMMU)
Historical Stock Chart
From Mar 2023 to Mar 2024