Immunicum AB: Quarterly Report January-March 2017
May 19 2017 - 12:35AM
For immediate release Press Release
19 May 2017
Immunicum: Quarterly Report January-March 2017
Immunicum AB
(publ; First North Premier: IMMU.ST), a biopharmaceutical company
advancing a novel immuno-oncology treatment against a range of
solid tumors, today announced its financial results and a corporate
update for the first quarter 2017.
First quarter in brief
Financial summary
- Operating loss amounted to TSEK -20,533 (-9,528
TSEK)
- Net loss amounted to TSEK -20,639 (-9,611
TSEK)
- Earnings per share before and after dilution
amounted to SEK -0.80 (SEK -0.48)
- Bank balances and short-term investment amounted
to TSEK 93.853 (TSEK 42.938)
- Shareholders' equity per share amounted to SEK
3.15 (SEK 1.93)
- Number of employees at the end of the period was
11 (7)
CEO Statement - first quarter
The first quarter of 2017 was an
intense period of activity for Immunicum and the Company's
management team has achieved key steps on the path toward reaching
our overall goals. Our primary focus is on the continued
development of our cell-based therapy for the treatment of solid
tumors, INTUVAX®, for which we completed important manufacturing
advances among other regulatory milestones; we have expanded our
leadership team to build a solid foundation to achieve success and
we have been active in positioning Immunicum to compete on a global
basis in our industry.
Most important has been our
progress in the clinical trials with INTUVAX, Immunicum's unique
cancer immune primer for the treatment of kidney and liver cancer
as well as GastroIntestinal Stromal Tumors (GIST).
Renal Cell
Carcinoma (RCC) - As of today, the enrollment 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 that we have a total of 58 patients
enrolled at 26 centers in eight European countries. We are
excited to include in this total the treatment of the first patient
in France, resulting from the approval by the French regulatory
authorities for the trial, as we announced in the first
quarter. It is important to emphasize the achievement this
regulatory approval represents: France is a large market and
one that is highly regulated in particular for cell-based
therapies. Gaining access to the clinics and patients in
France supports further patient enrollment. It also provides
further recognition of our approach and its potential for treating
cancer.
Along the lines of providing
detail on the additional steps required for the clinical
development of a cell-based therapy like INTUVAX, I am pleased to
give an update on the extension of the MERECA trial in the United
States. As announced in December 2016, Immunicum received clearance
on its Investigational New Drug (IND) application to the Food and
Drug Administration (FDA) with INTUVAX. Since that time, we have
focused our efforts on achieving all the steps needed to enable the
recruitment of patients in the clinical centers in the US. With the
FDA clearance as the necessary start of the process, Immunicum has
since obtained authorization for the German INTUVAX manufacturing
facility to produce the product as defined by the FDA, which
required additional approvals in Germany for the production of the
INTUVAX cells. Only after the successful production and shipping of
INTUVAX to the centers in the US could the clinicians at those
centers start the pre-screening of patients for the trial. At
this stage, the pre-screening process has been underway since
mid-April, and we anticipate the first patients to be ready for
treatment during the second quarter of 2017.
Hepatocellular
Carcinoma (HCC) - As previously reported, we have now enrolled
the last of the six additional liver cancer patients that receive
INTUVAX concomitantly with first line standard of care medication
in the extension of the study. Top line results from this
trial are expected in the third quarter of 2017.
GastroIntestinal
Stromal Tumors (GIST) -Following the protocol amendment, our
collaborators at the Karolinska UniversitetsSjukhuset have now
enrolled 3 patients in our clinical phase I/II study with INTUVAX
in patients with GIST.
Operations -
Over the course of the first quarter we invested time and effort in
meeting all the requirements for the Nasdaq Stockholm uplisting
process, which the committee acknowledged we had achieved in their
review of our application. As we announced earlier this quarter,
the committee delayed their approval based on the desire to see
that we can maintain all corporate governance and communications
standards in an ongoing manner and establish a longer track
record. We are committed to meeting these requirements to
achieve our listing on the Nasdaq Stockholm.
As another focus for the long-term
achievement of our corporate goals, we remain active in raising the
awareness of the Company and our products in development. In
addition to adding a key member to the team to support overall
business development, during the first quarter, I have been active
at several events and conferences in the US and Europe. The goal is
to introduce the Company to key audiences in the international
biotechnology industry, including other biotech and pharmaceutical
companies, international investors and industry
thought-leaders.
We as a leadership team, together
with the Board of Directors, are focused on building value for our
shareholders through the rigorous development of our clinical
programs and the vision to increase the opportunities for success.
We are grateful for your continued support and confidence.
Carlos de
Sousa
President and CEO
Business highlights
- The Agence Nationale de Sécurité du Médicament et
des Produits de Santé (ANSM) in France approved the Company's
Clinical Trial Application (CTA) for INTUVAX. The CTA
approval enables Immunicum to include patients in France in its
ongoing Phase II study - MERECA (MEtastatic REnal Cell CArcinoma) -
for the treatment of metastatic renal cell cancer.
- Following the announcement in the first quarter
of the first patient enrolled in the Phase I/II Gastrointestinal
Stromal Tumor (GIST) study following the study protocol amendment
as approved by the ethical committee and the Swedish Medical
Products Agency, a total of 3 patients have now been included in
the trial. The study is conducted in collaboration with the
Karolinska Sjukhuset and investigates the safety and efficacy of
INTUVAX® in combination with tyrosine kinase inhibitors in patients
with incurable GIST.
- Sijme Zeilemaker joined the leadership team of
Immunicum as Senior Director, Business Development.
- Nasdaq Stockholm's listing committee postponed
the decision on Immunicum's application for admission to trading.
Although the committee recognized that Immunicum has achieved the
requirements needed for companies listed on Nasdaq Stockholm, the
committee requested that Immunicum continues to apply them for a
longer period before the committee can make a final decision on the
application.
Significant events after end of period
- At the Annual General Meeting on April 26, 2017,
The AGM re-elected the current board members Agneta Edberg, Martin
Lindström, Magnus Nilsson, Magnus Persson, Steven Glazer, Charlotte
Edenius and Kerstin Valinder Strinnholm as board members. Agneta
Edberg was re-elected as chairman of the board of directors.
- The AGM resolved to authorize the board, for the
period until the end of the next annual general meeting, at one or
more occasions and with or without deviation from the shareholders'
preferential rights, to issue a maximum of 2,595,000 new shares and
warrants or convertible debentures giving a right to subscribe for
a maximum of 2,595,000 shares. If fully exercised, the
authorization corresponds to approximately 10 percent of the
current share capital and votes in the Company.
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 May 19, 2017 at 08.00 CET.
Financial Calendar |
Interim Report
Q2 2017: 18 August 2017 |
Interim Report Q3 2017: 17 November
2017 |
Year-end report 2017: 16 February
2018 |
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 Joanne Tudorica
Telephone: +49 89 2424 3494 or + 49 172 861 8540
E-mail: gschweitzer@macbiocom.com or
jtudorica@macbiocom.com
The Company's Certified Adviser is Redeye
AB
Telephone: +46 (0) 8 545 013 31
www.redeye.se
About
Immunicum AB (publ) Immunicum AB (First North Premier: IMMU.ST) is
a clinical stage Company developing novel immuno-oncology therapies
against a range of solid tumors. The Company's lead compound,
INTUVAX® is currently being evaluated in clinical trials for the
treatment of kidney cancer, liver cancer and gastrointestinal
stromal tumors. INTUVAX® was designed to combine the best of two
worlds: a cost-effective cell-based (allogeneic) and off-the-shelf
therapy that is capable of triggering a highly personalized and
potentially long-lasting immune response against tumor cells
throughout the body. www.immunicum.com |
Q1 2017 Eng 170519 0010
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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