Immunicum AB (publ): Interim Report Q3 - Corporate Update and Outlook
November 17 2017 - 02:00AM
Press Release
17 November 2017
Immunicum AB (publ): Interim Report Q3 - 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 third quarter 2017.
CEO Comment - Third quarter
Our vision as a Company is to
advance ilixadencel as a novel therapy for the treatment of solid
tumors and to continue the strategic development of our pipeline to
build long-term value for our shareholders. This past quarter and
the weeks up until this report have been particularly exciting
because we have achieved several scientific and clinical milestones
and initiated a financial transaction to support our vision and
long-term success.
Most importantly, we completed the
HCC Phase I/II clinical study with positive safety and tolerability
results as well as encouraging immune system activation data.
Beyond the positive clinical data, we were pleased to announce the
presentation of preclinical ilixadencel mode of action data at the
Society for Immunotherapy of Cancer (SITC) 32nd Annual
Meeting .
Looking forward, we have announced
with our Board of Directors a Rights Issue that will support the
ongoing operations and allow the Company to implement the next
phase of our updated clinical development plan. We designed this
plan with a clear focus on increasing the opportunities for
ilixadencel in the evolving cancer therapeutic landscape based on
its applicability in a variety of solid tumors, its potential
synergistic effects with other cancer therapies and its encouraging
safety profile. In order to minimize shareholder dilution while
maximizing value creation for the Company and ilixadencel,
Immunicum's management and board made the decision to finance the
plan in stages. The secured proceeds from the announced Rights
Issue will ensure that the Company and its ongoing projects are
fully financed until completion in 2019, while also providing
valuable data in combination with checkpoint inhibitors in three
interesting new indications, advancing ilixadencel's potential on
multiple fronts. While we still believe that HCC represents a very
attractive indication where ilixadencel could make a significant
impact to existing treatment, we also believe that it is important
for the Company to reach its key value inflection points.
Therefore, we will stay focused on achieving those milestones in
the near-term and remain open to strategic options that could
support a Phase II trial in HCC. The proceeds from the announced
Rights Issue will allow us to concentrate on fulfilling
ilixadencel's potential in multiple indications and combinations,
while simultaneously taking the Company to the next stage of its
development. Speaking for the management team, all of whom will
participate in the Rights Issue, and as a company, we are committed
to the opportunity before us to build value for our shareholders
and bring innovative treatments to patients.
Carlos de
Sousa
President and CEO
Significant events during the third quarter
-
The first patient was enrolled in the United
States (US) as part of the Company's ongoing global Phase II 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. Positive topline results from
the study were announced end of September. Ilixadencel was shown to
be safe and well tolerated in these patients when given both as a
single treatment and in combination with the current first line
standard of care treatment, sorafenib. In addition, the results
provide evidence of tumor-specific immune activation in the
majority of patients.
-
Immunicum's leadership team, together with its
Board of Directors and external advisors, completed a 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.
Significant events after end of period
-
Sharon Longhurst was appointed as Head of
Chemistry, Manufacturing and Controls (CMC). She will support
Immunicum's objective to develop a commercially-ready manufacturing
process for lead product, ilixadencel.
-
The Company announced that Immunicum's Board of
Directors resolved on a new issue of shares which will result in
total proceeds of approxmately SEK 223 million before transaction
costs, assuming the new share issue is fully subscribed. A
guarantee consortium has, subject to certain conditions, undertaken
to subscribe for new shares to such extent that the new share issue
is secured up to SEK 200 million. The new Rights Issue with
preferential rights for existing shareholders (the "Rights Issue")
is subject to subsequent approval of an extraordinary general
meeting.
-
Ilixadencel mode of action data was presented at
the Society for Immunotherapy of Cancer (SITC) 32nd Annual
Meeting. The preclinical results show how ilixadencel induces
several complementary immunological processes that are needed in
order to prime the immune system to recognize and destroy cancer
cells.
-
Immunicum announced two online publications of
preclinical studies investigating the mode of action of ilixadencel
in the prestigious scientific journal Oncoimmunology. The studies show the multiple ways in
which ilixadencel, or corresponding allogeneic proinflammatory
mouse dendritic cells, create an immune-priming environment.
Financial Summary
Third quarter (July-September)
2017 compared with the same period in 2016
-
The operating loss amounted to TSEK -21,597
(TSEK -12,018)
-
Net loss amounted to TSEK -21,659 (TSEK
-11,985)
-
Earnings per share before and after dilution
amounted to SEK -0.83 (SEK -0.46)
The period January-September 2017
compared with the same period in 2016
-
The operating loss amounted to TSEK -61,245
(TSEK -36,614)
-
Net loss amounted to TSEK -61,512
(TSEK-36,614)
-
Earnings per share before and after dilution
amounted to SEK -2.37 (SEK -1.65)
-
Cash and cash equivalents plus funds invested in
mutual fund amounted to TSEK 53,112 at 30 September 2017 (TSEK
129,032)
-
Shareholders' equity per share amounted to SEK
1.57 (SEK 4.90)
-
Number of employees at the end of the period was
10 (9)
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 17, 2017 at 08.00 CET.
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: ir@immunicum.com
Investor and Media Relations EU/US
MacDougall Biomedical
Communications
Joanne Tudorica
Telephone: +49 89 2424 3494
E-mail: ir@immunicum.com
The Company's Certified Adviser is
Redeye AB
Telephone: +46 (0)8 545 013 30
www.redeye.se
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
|
Q3 Report 2017_ENG_Final
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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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