Report for period 1 January - 31 December 2016
-
Net sales were 59 (0) KSEK
-
Loss after financial items was 9,235
(-7,479) KSEK
-
Earnings per share were -0.32 (-0.26)
SEK
-
Cash flow from operating activities was
-7,168 (-9,127) KSEK
Reporting period 1 October - 31 December 2016
-
Net sales were 13 (0) KSEK
-
Loss after financial items was -1,840
(-1,622) KSEK
- Cash flow from operating activities was -3,882
(-2,442) KSEK
- Work was initiated to construct a company-owned
laboratory for product development use as well as customer support
and service.
- Ann Hammarstrand was appointed as new CFO
and Kris Rydholm Överby was appointed PR/Marketing Communication
Manager.
This information is information that AroCell is obliged to make
public pursuant to the EU Market Abuse Regulation and the
Securities Markets Act. The information was submitted for
publication, through Jan Stålemark, at 08:15 CET on 16 February
2017.
About AroCell
AroCell AB (AROC) is a Swedish
company that develops standardized modern blood tests to support
the prognosis and follow up of cancer patients. AroCell's new
technology is based on patented methods to measure TK1 protein
levels, which provide valuable information about the speed of cell
turnover. A tumor has high cell turnover (speed of cell division
and cell death) and as a result TK1 can be detected in the blood
with a simple laboratory test, called TK 210 ELISA. The test
provides valuable clinical information for prognosis and
optimization of treatment strategy. The test may also be used for
monitoring disease relapse. AroCell (AROC) is listed at Nasdaq
First North and has about 2,600 shareholders. For more
information, please see www.arocell.com.
Redeye AB is AroCell:s Certified Adviser.
Significant events during the
reporting period
-
A clinical study using TK 210 ELISA on serum
samples from breast cancer patients showed significantly higher
sensitivity compared to available TK1 activity tests. The study
also showed increased diagnostic sensitivity when combined with the
most-used serum biomarker CA 15-3 supporting the potential of our
product to be used for the purpose of better treatment
planning.
-
AroCell strengthens its IP protection. The
European Patent Office granted AroCell a patent related to an
invention relating to exposed Thymidine Kinase 1 (TK1) derived
peptides, ligands and methods employing these.
-
Christine Tadgell, VP Commercial Group, inVentiv
Health joined the board of AroCell.
-
Clinical validation for prostate cancer
application started in a prospective study at Stockholm South
General Hospital. The study aims to provide better information to
the clinicians how to treat patients with suspected and confirmed
prostate cancer. The study is expected to be concluded during
autumn 2018.
-
TK 210 ELISA is being validated as one of very
few biomarkers available for patients with sarcoma. A clinical
study regarding sarcoma cancer using TK 210 ELISA was initiated at
Helsinki University Hospital in a national study in Finland to
evaluate the prognostic value, monitoring of treatment effect and
follow up after treatment for early detection of relapse. The study
is expected to be concluded by autumn 2018 and will potentially
make TK 210 ELISA a new and unique biomarker for patients with
sarcoma.
-
AroCell was listed on the Nasdaq First North
exchange on June 30.
-
An abstract on the improved performance of the
0-calibrator for TK 210 ELISA was accepted and presented at the
ISOBM conference by AroCell in Chicago September, 2016. TK 210
ELISA sensitivity has thus been improved making discrimination
between healthy individuals and patients with disease significantly
better.
-
AroCell signed a distribution agreement with
Eagle Biosciences Inc. Eagle Biosciences will initially focus on
cancer research centres in the North American marketplace. North
America represents approximately 50% of the global IVD
market.
-
A chemistry laboratory was established in new
facilities at the company headquarters in Uppsala. This will
improve capacity of product development, quality control and
customers support.
-
Management team strengthened with the
appointment of Martin Shaw as Business Development Manager. Martin
brings over 40 years of experience in the biomarker and the IVD
business. The executive management group strengthened with the
appointment of new CFO Ann Hammarstrand. Her long experience in
financial management and multiple executive roles in life science
companies with worldwide responsibilities adds very important
experience to the company as AroCell expands on the global IVD
market.
-
AroCell strengthens market communication and PR.
Kris Rydholm Överby has been appointed as PR and Marketing
Communication Manager. Kris brings more than 30 years of marketing
experience from multiple international life sciences companies and
being a certified medical writer which will be important function
for the company as study results become available from the clinical
validation of TK 210 ELISA.
Significant
events after the reporting period
-
A scientific poster has been accepted by AARC,
American Association of Cancer Research, 2017 for presentation at
their annual meeting in April. Preliminary results from AroCell's
TK 210 ELISA test showed significant correlation with Prostate
Health Index (PHI), a new index to determine patient status for
patients with suspected or confirmed prostate cancer. The study
compare AroCell's TK 210 ELISA test with other commonly used test
methods such as PSA, free PSA, pro PSA and PHI in men with
pre-cancerous conditions and confirmed prostate cancer indicates
that AroCell's TK 210 ELISA test provides valuable clinical
information.
Comments by CEO
Jan Stålemark
2016 has been a very active and rewarding year for
AroCell. The continued clinical validation is a key component in
our strategy to attain clinical acceptance and successfully
introduce our product on the global in vitro diagnostic market for
multiple applications within cancer therapy.
Two recent studies indicate that our product TK
210 ELISA adds clinical value independently and when combined with
other biomarkers. This supports one of the very strong trends in
the diagnostic market which is the use of biomarker panels.
The first study, published in Journal of Tumor
Biology, showed that our test has higher sensitivity and
specificity than one of the most currently used biomarkers for
breast cancer, CA 15-3. The study also showed that our test in
combination with the CA 15-3 biomarker further increases both
sensitivity and specificity to identify patients with tumors. The
second study compared our TK 210 ELISA with the well-known
biomarkers PSA, free PSA, pro PSA and Prostate Health Index (PHI)
in men with suspected or confirmed prostate cancer. TK 210 ELISA
shows significant correlation with PHI which support that TK 210
ELISA can provide important clinical information on prostate cancer
patients supporting the potential of our product to be used for the
purpose of better treatment planning. A scientific poster on this
study has been accepted by AACR (American Association for Cancer
Research) 2017 for presentation at their annual meeting in April in
Washington DC.
Two prospective studies are currently ongoing, in
prostate cancer and sarcoma. The prostate cancer study aim to
establish TK 210 ELISA as a complementary biomarker for certain
prostate cancer applications. The sarcoma study will potentially
make TK 210 ELISA a new and unique biomarker for patients with
sarcoma. Twenty-five percent of children with cancer are diagnosed
with sarcoma. Early detection of relapse may lead to curative
treatment for these patients. Both studies are estimated to be
finished by the end of 2018.
The company strategy to address the clinical
research centres has started with the collaboration with our
distributor in the US, Eagle BioSciences Inc. We are also building
awareness in EU and now begin to see interest from the customers.
The plan is to continue and work through distributors also in EU
and other parts of the world. In the first phase, we target
primarily the clinical research and pharmaceutical development
segments which is in line with our strategy to build clinical
evidence for our product in many applications.
Our product is the first and only CE-marked ELISA
kit on the market that can measure concentrations of TK 1 protein
in serum from a simple blood test. The TK 210 ELISA test has a
standardized format that is available for use in all modern
clinical chemistry laboratories which makes it very easy to
introduce to new customers for our new Business Development
manager.
AroCell now has positive study results in several
therapeutic areas, which means we can now begin to more
aggressively talk about the clinical application of TK 210 ELISA as
a valid biomarker either alone or within a panel of
biomarkers. We have engaged a distributor to do this in the
US and a Business Development manager in the EU so that we can
raise awareness and interest in our unique product. The total
market for cancer diagnostics is large* and growing and the market
share potential for AroCell can be very significant.
We expect to share new interesting results in the
clinical validation of our product and that we will begin to
translate these results into market opportunities throughout
2017.
Jan Stålemark
CEO
* Kalorama Information 6th Edition
2014, Global IVD market for cancer was estimated to 22.6 billion US
dollars
Essential risks
Financial
risks
AroCell's business activities are based on
external financing. To date, the company has been successful in
obtaining financing, but there are not guarantees of this happening
in the future in a way that is advantageous to the company's
shareholders. A sufficiently serious failure in future financing
may affect the company's development and market value.
Development and production
risks
Development and transfer to production are always
associated with risks. A product manufactured at production scale
does not always display exactly the same characteristics as one
manufactured at research scale. Developing future products may also
prove to be more complicated and take longer than expected.
Commercialization risks
There is always a risk that the products AroCell
has developed will not achieve the expected positive reception on
the market and that the product will need longer time to gain
acceptance. Particularly in the early stages, the quantity of
products sold may then be lower and the time it takes to establish
the product on the market may be longer than the company allowed
for in its sales estimates.
Currency
risks
The company expenses are partially
based in Euro, and this means that there is a risk that weakening
of the Swedish krona against the Euro may lead to increased
expenses for the company. A portion of the sales proceeds in future
can be associated with currencies from other countries, which means
that there is a risk that if the Swedish krona becomes stronger to
other currencies, this may lead to decreased profits for the
company in SEK.
In addition, there are risks associated with
patent security and how the market assesses studies, approvals and
certifications. Taking risk factors into consideration in decision
processes and when designing routines and drawing up documentation
means that the risks are assessed and their effects can be
minimized, and to some extent, avoided.
The share
AroCell AB (publ) was listed on Nasdaq First
North, Stockholm, June 30 2016 under AROC.
On December 31 2016 there were
28 674 506 shares (quota value SEK 0,10).
|
|
|
Largest
shareholder |
Shares |
Votes
% |
Name |
2016-12-31 |
|
FÖRSÄKRINGSAKTIEBOLAGET, AVANZA PENSION |
3 373
889 |
11,77% |
TRIBUKAIT,
BERNHARD |
1 236
796 |
4,31% |
STAFFAN ERIKSSON MED
BOLAG |
1 077
862 |
3,76% |
NORDNET
PENSIONSFÖRSÄKRING AB |
798 207 |
2,78% |
JON EIKEN |
650 000 |
2,27% |
GUNVALD
BERGER |
634 852 |
2,21% |
OLLE STENFORS |
540 000 |
1,88% |
UBS SWITZERLAND AG
/CLIENTS ACCOUNT |
497 529 |
1,74% |
SWEDBANK |
351 210 |
1,22% |
HÅKAN ENGLUND MED
BOLAG |
341 478 |
1,19% |
Övriga |
19 172
683 |
66,86% |
Total |
28,674,506 |
100,00% |
Dividend proposal
The board proposes that no dividends should be issued for the
accounting year of 2016.
Accounting
principles
This Year End Report has been prepared in
accordance with the Swedish law: Årsredovisningslagen and
Bokföringsnämndens allmänna råd BFNAR 2012:1 Årsredovisning och
Koncernredovisning (K3).
Report review
This Year End Report has not been reviewed by the
company auditor.
Contact information
Jan Stålemark VD
AroCell AB (publ)
Virdings allé 32B
754 83 UPPSALA
SWEDEN
jan.stalemark@arocell.com
+46(0)706-92 62 06
www.arocell.com
The Annual
General Meeting
The Annual General Meeting will be held on
Wednesday 18 May 2017 at 15.00 hours at the corporate headquarters
at Virdings allé 32 B i UPPSALA.
Financial
information
The Annual Report will be published on the company
website www.arocell.com at least two weeks prior to the Annual
General Meeting and will then also be available from the company at
info@arocell.com.
Financial
calendar
2017-05-11 Interim report
1 2017
2017-05-18 Annual
General Meeting
2017-08-24
Interim report 2 2017
2017-11-23 Interim report
3 2017
2018-02-22 Year End Report
2017
Delivery of
interim report
Uppsala February 15, 2017
The board of directors
Summary Income statement |
|
|
|
|
|
(TSEK) |
|
2016 |
2015 |
2016 |
2015 |
|
|
Oct-Dec |
Oct-Dec |
Jan-Dec |
Jan-Dec |
|
|
3 mths |
3 mths |
full year |
full year |
Net
sales |
|
13 |
- |
59 |
|
Operating expenses |
|
-1,904 |
-1,641 |
-9,280 |
-7,478 |
Depreciation of tangible fixed assets |
|
-4 |
-1 |
-8 |
-7 |
Operating loss |
|
-1,895 |
-1,642 |
-9,229 |
-7,485 |
Financial income/expenses |
|
55 |
20 |
-6 |
6 |
Loss after financial items |
|
-1,840 |
-1,622 |
-9,235 |
-7,479 |
Income
taxes |
|
- |
- |
- |
- |
Loss for the period |
|
-1,840 |
-1,622 |
-9,235 |
-7,479 |
|
|
|
|
|
|
|
|
|
|
|
|
Summary balance sheet |
|
|
|
|
|
(TSEK) |
|
|
|
2016 |
2015 |
|
|
|
|
Dec 31 |
Dec 31 |
ASSETS |
|
|
|
|
|
Fixed
assets |
|
|
|
|
|
Intangible assets |
|
|
|
31,328 |
21,810 |
Tangible assets |
|
|
|
170 |
14 |
Total fixed assets |
|
|
|
31,498 |
21,824 |
Current asset |
|
|
|
|
|
Inventories |
|
|
|
1,419 |
1,419 |
Other
receivables |
|
|
|
652 |
1,378 |
Cash
and cash equivalents |
|
|
|
32,852 |
49,702 |
Total current assets |
|
|
|
34,923 |
52,499 |
Total assets |
|
|
|
66,421 |
74,323 |
|
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
Share
capital |
|
|
|
2,867 |
2,867 |
Other
contributed capital and reserves |
|
|
|
69,824 |
77,303 |
Non-restricted equity |
|
|
|
-9,235 |
-7,479 |
Total equity |
|
|
|
63,456 |
72,691 |
Long-term liabilities |
|
|
|
0 |
0 |
Current liabilities |
|
|
|
2,965 |
1,632 |
Total equity and liabilities |
|
|
|
66,421 |
74,323 |
|
|
|
|
|
|
|
|
|
|
|
|
Summary cash flow statement |
|
|
|
|
|
(TSEK) |
|
2016 |
2015 |
2016 |
2015 |
|
|
Oct-Dec |
Oct-Dec |
Jan-Dec |
Jan-Dec |
|
|
3 mths |
3 mths |
full year |
full year |
Cash
flow from operating activities |
|
-3,882 |
-2,442 |
-7,168 |
-9,127 |
Cash
flow from investing activities |
|
-2,287 |
-1,288 |
-9,682 |
-3,984 |
Cash
flow from financing activities |
|
0 |
18,099 |
0 |
44,300 |
Cash flow from the period |
|
-6,169 |
14,369 |
-16,850 |
31,189 |
Cash
and cash equivalents at beginning of period |
|
39,021 |
4,144 |
49,702 |
18,513 |
Cash and cash equivalents at end of
period |
|
32,852 |
18,513 |
32,852 |
49,702 |
Share data |
|
|
|
2016 |
2015 |
|
|
|
|
Jan-Dec |
Jan-Dec |
|
|
|
|
|
|
Earnings per share (SEK) |
|
|
|
|
|
Before
dilution |
|
|
|
-0,32 |
-0,26 |
After
dilution |
|
|
|
-0,32 |
-0,26 |
|
|
|
|
|
|
Average number of shares |
|
|
|
|
|
Before
dilution |
|
|
|
28,674,506 |
28,674,506 |
After
dilution |
|
|
|
28,674,506 |
28,674,506 |
|
|
|
|
|
|
Number
of shares on balance sheet date |
|
|
|
|
|
Before
dilution |
|
|
|
28,674,506 |
23,797,318 |
After
dilution |
|
|
|
28,674,506 |
23,797,318 |
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: AroCell AB via Globenewswire
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