Interim report, 3Q 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 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.

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

The interim report has not been reviewed by the company’s auditor.
Submission of interim report: Uppsala, 10 November 2015
The Board of Directors

 

For full report click the following links:

Interim report, 1 January – 30 September 2015, PDF
Report in Swedish, PDF

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Summary Income statement
(TSEK) 2015 2014 2015 2014 2014
Jul-Sep Jul-Sep Jan-Sep Jan-Dec Jan-Dec
3 mths 3 mths 9 mths 9 mths full year
Net sales 0 0 0 0 0
Operating expenses -1,804 -1,054 -5,837 -3,566 -3,667
Depriciation of tangible fixed assets -2 -8 -6 -25 -33
Operating loss -1,806 -1,062 -5,843 -3,591 -3,700
Financial income 0 5 0 12 36
Financial expenses -5 -7 -14 -31 -69
Loss after financial items -1,811 -1,064 -5,857 -3,610 -3,733
Income taxes 0 0 0 0 0
Loss for the period -1,811 -1,064 -5,857 -3,610 -3,733
Summary balance sheet
(TSEK) 2015 2014 2014
Sep 30 Sep 30 Dec 30
ASSETS
Fixed assets
Intangible assets 21,182 16,544 17,826
Tangible assets 15 23 21
Total fixed assets 21,197 16,567 17,847
Current asset
Inventories 1,439 1,519 1,578
Other receivables 285 181 664
Cash and cash equivalents 10,331 4,144 18,513
Total current assets 12,055 5,844 20,755
Total assets 33,252 22,411 38,602
EQUITY AND LIABILITIES
Share capital 2,346 1,920 2,346
Other contributed capital and reserves 33,374 22,020 39,743
Non-restricted equity -5,857 -3,610 -6,369
Total equity 29,863 20,330 35,720
Long-term liabilities 0 200 150
Current liabilities 3,389 1,881 2,732
Total equity and liabilities 33,252 22,411 38,602
Summary cash flow statement
(TSEK) 2015 2014 2015 2014 2014
Jul-Sep Jul-Sep Jan-Sep Jan-Dec Jan-Dec
3 mths 3 mths 9 mths 9 mths full year
Cash flow from operating activities -891 -491 -4,676 -3,284 -5,726
Cash flow from investing activities -1,352 -2,206 -3,356 -5,411 -6,699
Cash flow from financing activities -50 -94 -150 7,844 25,943
Cash flow from the period -2,293 -2,791 -8,182 -851 13,518
Cash and cash equivalents at beginning of period 12,624 6,935 18,513 4,995 4,995
Cash and cash equivalents at end of period 10,331 4,144 10,331 4,144 18,513
Share data
2015 2014 2014
Jan-Sep Jan-Dec Jan-Dec
Earnings per share (SEK)
Before dilution -0.25 -0.19 -0.32
After dilution -0.25 -0.18 -0.32
Average number of shares
Before dilution 23,460,960 19,035,542 19,786,428
After dilution 23,460,960 19,669,291 19,786,428
Number of shares on balance sheet date
Before dilution 23,460,960 19,195,332 23,460,960
After dilution 23,460,960 23,460,960 23,460,960

 

 

Change in equity (TSEK)
Share capital Other contributed capital Retained earnings     incl. loss for the year Total equity
Opening balance 2,346 39,743 -6,369 35,720
Allocation in accordance with
resolution at AGM -6,369 6,369
Loss for the period -5,857 -5,857
Closing balance 2,346 33,374 -5,857 29,863