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2015-11-10

AroCell: Interim report, 1 January - 30 September 2015

Interim report, 1 January - 30 September 2015

· Net sales were TSEK 0 (0)
· Loss after financial items was TSEK -5,857 (-3,610)
· Earnings per share where SEK -0.25 (-0.19)
· Cash flow from operating activities was TSEK -4,676 (-3,284)

Reporting period, 1 July - 30 September 2015

· Net sales were TSEK 0 (0)
· Loss after financial items was TSEK -1,811 (-1,064)
· Cash flow from operating activities was TSEK -891 (-491)
· TK 210 ELISA test successfully passes phase 1 review of production
process

· AroCell recognized by EU Commission and Horizon 2020
· CE-marking of TK 210 ELISA achieved

· Continued expansion to AroCell organization

About AroCell

AroCell AB (publ) 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
concerning 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 is listed on the AktieTorget
marketplace in Sweden and has about 2,300 shareholders. For more
information, please see (http://www.arocell.com/)www.arocell.com.

Significant events during the reporting period

· AroCell's TK 210 ELISA product successfully passed phase 1
verification review, which is a critical milestone in development of
the production process for the TK 210 ELISA test. This verifies that
the production process can attain full-scale product production.

· Two clinical studies have been completed and with analysis of
results. Both studies indicate that the TK 210 ELISA product delivers
the required performance for clinical use and for CE-marking.

· AroCell has been recognized as "one of the companies with the most
innovative ideas in the world" by the EU Commission and the Horizon
2020.

· AroCell has filed TK 210 ELISA for the CE-mark registration at the
Swedish Medical Products Agency (Läkemedelsverket). The CE-mark is a
symbol of quality and is an essential step for the continued clinical
validation needed to obtain full clinical acceptance of a diagnostic
product.

Significant events after the reporting period

· AroCell reinforces the company organization with the employment of
Kiran Kumar Jagarlamudi, PhD as product specialist.

· AroCell presented its TK 210 ELISA test at the annual ISOBM
(International Society of Oncology and Biomarkers) congress on
October 3-7, 2015 in Zakopane, Poland. The TK 210 ELISA test was
presented as a robust tool for researchers and clinicians, with good
sensitivity and product performance in measuring TK1 protein in
serum.

· The Board of Directors has resolved on November 5, 2015, with
support of the decision taken at the Annual General Meeting, a
preferential rights issue of a maximum of 5 213 546 shares. Full
subscription of the preferential rights issue will provide AroCell
with a maximum of approximately 52.2 MSEK before issue expenses. The
company has received subscription undertakings from members of the
board of directors, management and the company's largest shareholders
and signed agreements accordingly to fully guarantee the preferential
rights issue.

Comments from Jan Stålemark, CEO of AroCell

AroCell has now achieved an historical milestone. Our TK 210 ELISA
test kit has been fully developed, achieved the CE-mark and is now
commercially available, primarily for research and clinical
development. It is the first and only ELISA kit on the market that
can measure TK1 protein in serum from a standard blood sample. This
fully enables us to initiate the next step in our plan - the critical
and final clinical validation to confirm the clinical value of our
product. We have already demonstrated how well the product has worked
in smaller clinical studies, and established that the sensitivity is
now sufficient to be used for several different types of cancers.

It is a very valuable investment to conduct clinical studies with this
type of product as early as possible in order to effectively drive
the marketing and sales efforts based on strong evidence-based
clinical results. The results from these clinical studies will also
establish the basis to generate health economic data. This data in
turn is critical to create opportunities to obtain health care
reimbursement for the TK 210 ELISA test in health care reimbursement
systems. Without reimbursement, it is extremely unlikely that the
product will be used frequently and successfully on a large scale.
Our clinical development efforts are therefore one of the
cornerstones in our plan for a successful market introduction

The results from planned clinical studies will be presented
continually during the next three year period. The first results may
already be presented already during the first six months of 2016,
with access to planned biobank materials as a prerequisite. These
results will be based on retrospective studies, which enable a
relatively short process for data collection and analysis. We plan to
conduct several of these studies and present results continually
during this time period. We also plan to conduct so-called
prospective studies as early as possible. These studies are based on
collected samples for continuous analysis during the study period,
which means that these types of studies take a more significant
amount of time, up to five years before final results are available.

We currently have a very good product with performance that fulfils
the requirements of a highly competitive in vitro diagnostic test.
During development, we have also identified good opportunities to
continue to improve product performance and to reduce production
costs. We therefore plan to initiate a project during 2016 to
optimize production.

As we have previously reported, we have determined that this
preferential rights issue will provide us with enough resources to
complete the clinical development of TK 210 ELISA and will create
significant value for an established in vitro diagnostic company in
the large and rapidly-changing market of cancer diagnostics.

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 no 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 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.

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 minimised and, to some extent,
avoided.

Accounting principles

The interim report has been prepared in accordance with the same
accounting principles as in the company's most recent annual report,
i.e. pursuant to the Swedish Annual Accounts Act and taking into
consideration general guidelines, recommendations and statements
issued by the Swedish Accounting Standards Board.

The share

AroCell AB (publ) was listed on the AktieTorget marketplace on 25 May
2011. At 30 September 2015, there were 23,460,960 shares (quota value
SEK 0.10)

Contact information

Jan Stålemark, CEO

info@arocell.com

+46 (0)706-92 62 06

www.arocell.com

AroCell AB (publ)

Virdings Allé 32B

SE-754 50 UPPSALA

SWEDEN

Financial calendar

2016-02-16 Year-End report 2015

2016-05-10 Interim report no. 1 2016

2016-05-18 Annual general meeting 2016

2016-08-25 Interim report no. 2 2016

2016-11-17 Interim report no. 3 2016

2017-02-16 Year-End report 2016

The interim report has not been reviewed by the company's auditor.

Submission of interim report

Uppsala, 10 November 2015

The Board of Directors

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http://news.cision.com/arocell/r/interim-report--1-january---30-septembe...
http://mb.cision.com/Main/1010/9864186/442388.pdf

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