Press Releases


AroCell AB: Interim report, Q2 2017

AroCell AB (publ)
Reporting period 1 April - 30 June 2017

  • Net sales were 237 (0) KSEK
  • Losses after financial items were - 3,606 (- 1,962) KSEK
  • Earnings per share were - 0.27 (- 0.17) SEK
  • Cash flow from operating activities was - 3,163 (- 1,229) KSEK
  • Cash flow from investing activities was - 318 (- 1,800) KSEK

Interim report, 1 January - 30 June 2017

  • Net sales were 293 (0) KSEK
  • Losses after financial items were - 7,831 (- 4,804) KSEK
  • Earnings per share were - 0.27 (- 0.17) SEK

Revenues and expenses April - June 2017 (2016) KSEK
Sales for the period were 237 (0). Expenses were 3,771 (1,962). Taking into account capitalization of R&D, total expenses for the same period in 2016 amounted to 3,762. As the product has been fully developed and CE-marked, R&D expenses are no longer capitalized. According to plan marketing and sales expenses have increased which reflects our ambition to get TK 210 ELISA test to the market. Total cash flow for the period was -3,531 (-3,029). Cash at the end of the period was 24,423.

Revenues and expenses January - June 2017 (2016) KSEK
Sales for the period were 293 (0). Expenses were 8,052 (4,804). Taking into account capitalization of R&D, total expenses for the same period in 2016 amounted to 9,824. As the product has been fully developed and CE-marked, R&D expenses are no longer capitalized. According to plan marketing and sales expenses have increased which reflects our ambition to get TK 210 ELISA test to the market. Total cash flow for the period was -8,429 (-7,521). Cash at the end of the period was 24,423.

AroCell is obliged to make public this information 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 24 August 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 rate of cell turnover. A tumor has high cell turnover (rate 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 strategies. The test may also be used for monitoring disease relapse. AroCell (AROC) is listed at Nasdaq First North and has about 2,500 shareholders. For more information, please see www.arocell.com. Redeye AB is AroCell:s Certified Adviser.


CEO Comments

As a result of our increased commercial activities we have begun to receive the first commercial orders from customers which is encouraging. The increase in the interest of our TK 210 ELISA test comes from pharmaceutical companies, IVD (in vitro diagnostic) companies as well as academic research groups. The key point of interest is that TK 210 ELISA is unique and the only CE marked IVD test for measuring TK 1 protein concentrations on the market. The AroCell team has been actively promoting TK 210 ELISA with potential customers in the US, Europe and Asia to identify future business opportunities. Recently a road tour has taken place in Japan and valuable contacts established.

The clinical validation remains a priority to ensure customer acceptance and long term growth. We have made good progress in the clinical development plan and we are excited about the first results which have been submitted for publication. The biomarker data specific to TK 210 ELISA from the Swedish Promix multicentre study has been submitted for presentation at a scientific meeting towards the end of this year. We will be able to share these results when they have been accepted for publication.

The second half of the year will be focused on further increasing customer interactions and identifying new opportunities for using TK 210 ELISA in clinical practice. There is also a focus on the R&D program to provide further data to support the clinical use of TK 210 ELISA.

Jan Stålemark
CEO

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 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 March 31, 2017 there were 28 674 506 shares (quota value SEK 0.10).

Accounting principles
This Interim 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 interim report has not been reviewed by the companys auditor.

Contact information
Jan Stålemark VD                                                         AroCell AB (publ)
jan.stalemark@arocell.com                                           Virdings allé 32B
0706-92 62 06                                                                754 83  UPPSALA
www.arocell.com                                                           SVERIGE

Financial Calender

11/22/2017  Interim report 3 - 2017
02/22/2018  Interim report 4 - 2017
04/25/2018  Interim report 1 - 2018
08/23/2018  Interim report 2 - 2018

Submission of interim report

Uppsala August 23, 2017

The board of directors



Summary Income statement
(TSEK) 2017 2016 2017 2016 2016
Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
3 mths 3 mths 6 mths 6 mths full year
Net sales 237 - 293 - 59
Cost of goods sold -72 - -72 - -
Selling expenses -1,494 -968 -3,682 -2,394 -5,020
Administrative expenses -807 -625 -1,688 -1,343 -2,193
Research and development expenses -1,470 -369 -2,682 -1,067 -2,075
Operating loss -3,606 -1,962 -7,831 -4,804 -9,229
Net financial items -6
Loss after financial items -3,606 -1,962 -7,831 -4,804 -9,235
Loss for the period -3,606 -1,962 -7,831 -4,804 -9,235
Summary balance sheet
(TSEK) 2017 2016 2016
Jun 30 Jun 30 Dec 31
ASSETS
Fixed assets
Intangible assets 31,328 26,830 31,328
Tangible assets 475 11 170
Financial assets 50 - -
Total fixed assets 31,853 26,841 31,498
Current asset
Inventories 2,243 1,419 1,419
Other receivables 663 682 652
Cash and cash equivalents 24,423 42,181 32,852
Total current assets 27,329 44,282 34,923
Total assets 59,182 71,123 66,421
EQUITY AND LIABILITIES
Share capital 2,867 2,867 2,867
Restricted reserves 9,518 - 9,518
Other contributed capital and reserves 102,615 69,824 102,615
Non-restricted equity -59,376 -4,804 -51,544
Total equity 55,624 67,887 63,456
Current liabilities 3,558 3,236 2,965
Total equity and liabilities 59,182 71,123 66,421
Summary cash flow statement
(TSEK) 2017 2016 2017 2016 2016
Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
3 mths 3 mths 6 mths 6 mths full year
Cash flow from operating activities -3,163 -1,229 -8,061 -2,501 -7,168
Cash flow from investing activities -318 -1,800 -318 -5,020 -9,682
Cash flow from financing activities -50 0 -50 0 0
Cash flow from the period -3,531 -3,029 -8,429 -7,521 -16,850
Cash and cash equivalents at beginning of period 27,954 45,210 32,852 49,702 49,702
Cash and cash equivalents at end of period 24,423 42,181 24,423 42,181 32,852


Share data
2017 2016 2016
Jan-Jun Jan-Jun Jan-Dec
Earnings per share (SEK)
Before dilution -0.27 -0.17 0.32
After dilution -0.27 -0.17 0.32
Average number of shares 28 674 506 28 674 506 28 674 506
Interim report, Q2 2017

--
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

AroCell (publ): Interim report for period 1 January – 31 March 2017

AroCell AB (publ)

Interim report for period 1 January - 31 March 2017

  • Net sales were 56 (0) KSEK
  • Loss after financial items was - 4,225 (- 2,842) KSEK
  • Earnings per share were -0.15 (-0.10) SEK
  • Cash flow from operating activities was -4,898 (-1,272) KSEK
  • Cash flow from investing activities was 0 (-3,220) KSEK

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 08:25 CET on 11 May 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 seewww.arocell.com. Redeye AB is AroCell:s Certified Adviser.


Significant events during the reporting period

  • A scientific poster showing the correlation between TK 210 ELISA and Prostate Health Index (PHI) was accepted by AARC, American Association of Cancer Research.
  • AroCell participated at the World Biomarker Congress in Manchester, UK in February.
  • A webinar entitled "Improved Monitoring of Tumor Growth with a Novel Serum Proliferation Biomarker" was held on March 23rd, with 135 participants from both industry and academia.

Significant events after the reporting period

  • AroCell attended the AACR congress in Washington, DC together with its distribution partner Eagle Biosciences.
  • The Biomarker and World Congress in Philadelphia on May 2-4.

Comments by CEO Jan Stålemark

A key priority for Arocell in 2017 is to ensure that we have a strong strategic framework in place to maintain focus for our activities and drive commercial growth. We have identified key areas where we will focus on moving forward which include elements to support both the commercial and clinical strategies.

Our commercial activities have increased significantly during the last period. We have seen a very positive response to our diverse marketing activities. These activities have generated significant interest in our product, providing plenty of contacts and leads for us to follow up on. We are thereby now able to make advances in commercializing our CE-marked TK 210 ELISA kit into the clinical research market.

The clinical validation is a key focus to ensure customer acceptance for long term growth. We have made good progress in the clinical development plans and expect to be presenting preliminary and interesting results soon. The Swedish Promix multicentre study has been analysed and publication is planned. Both our prospective studies, Sarcoma at Helsinki hospital and Prostate cancer at the South Hospital in Stockholm are on plan and expected to be completed by the end of 2018. We have also completed the analysis of the biobank samples in the U-CAN study in Uppsala. The remaining work is to get the results analysed in correlation to the patient records which will be done by the clinicians at Uppsala Academic Hospital. This is key to our strategy in obtaining clinical acceptance through clinical validation, in order to introduce our product to the global in vitro diagnostic market.

As prostate cancer is a key component in our clinical development program, it is essential to communicate the results to the medical community. A scientific poster was presented at the AARC, American Association of Cancer Research. It shows significant correlation between results by TK 210 ELISA and Prostate Health Index (PHI), a new index to determine patient status for individuals 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.


  

We have the only CE-marked kit on the market that measures concentrations of TK 1 protein in serum from a simple blood test based on the global standardized ELISA format. Our product's uniqueness has generated interest well above our expectations during meetings with potential customers from the research and medical communities at trade shows and conferences. This will be a strong basis to find new partners and markets in 2017.

With a robust product, commercially available and with an increased customer interest, we are now putting full efforts behind our plans for launching the TK 210 ELISA kit into the clinical research market as well as the ongoing clinical development program.

Jan Stålemark
CEO

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 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 March 31, 2017 there were 28 674 506 shares (quota value SEK 0,10).

Accounting principles
This Interim 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 interim report has not been reviewed by the company's auditor.

Contact information
Jan Stålemark VD                                                         AroCell AB (publ)
jan.stalemark@arocell.com                                           Virdings allé 32B
0706-92 62 06                                                                754 83  UPPSALA
www.arocell.com                                                           SVERIGE

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 Calender
05/11/2017  Interim report 1
05/18/2017  Annual General Meeting
08/24/2017  Interim report 2
11/23/2017  Interim report 3
02/22/2018  Interim report 4

Submission of interim report

Uppsala May 10, 2017

The board of directors



Summary Income statement
(TSEK) 2017 2016 2016
Jan-Mar Jan-Mar Jan-Dec
3 months 3 months full year
Net sales 56 0 59
Cost of goods sold
Selling expenses -2 188 -1 426 -5 020
Administrative expenses -881 -718 -2 193
Research and development expenses -1 212 -698 -2 075
Operating loss -4 225 -2 842 -9 229
Net financial items 0 0 -6
Loss after financial items -4 225 -2 842 -9 235
Income taxes 0 0 0
Loss for the period -4 225 -2 842 -9 235
Summary balance sheet
(TSEK) 2017 2016 2016
Mar 31 Mar 31 Dec 31
ASSETS
Fixed assets
Intangible assets 31 328 25 030 31 328
Tangible assets 168 12 170
Total fixed assets 31 496 25 042 31 498
Current asset
Inventories 1 419 1 419 1 419
Other receivables 597 272 652
Cash and cash equivalents 27 954 45 210 32 852
Total current assets 29 970 46 901 34 923
Total assets 61 466 71 943 66 421
EQUITY AND LIABILITIES
Share capital 2 867 2 867 2 867
Restricted reservs 9 518 0 9 518
Other contributed capital and reserves 102 615 102 615 102 615
Non-restricted equity -55 769 -35 633 -51 544
Total equity 59 231 69 849 63 456
Long-term liabilities 0 0 0
Current liabilities 2 235 2 094 2 965
Total equity and liabilities 61 466 71 943 66 421
Summary cash flow statement
(TSEK) 2017 2016 2016
Jan-Mar Jan-Mar Jan-Dec
3 months 3 months full year
Cash flow from operating activities -4 898 -1 272 -7 168
Cash flow from investing activities 0 -3 220 -9 682
Cash flow from financing activities 0 0 0
Cash flow from the period -4 898 -4 492 -16 850
Cash and cash equivalents at beginning of period 32 852 49 702 49 702
Cash and cash equivalents at end of period 27 954 45 210 32 852

Share data
2017 2016 2016
Jan-Mar Jan-Mar Jan-Dec
3 months 3 months full year
Earnings per share (SEK) -0,15 -0,10 -0,32
Before dilution -0,15 -0,10 -0,32
After dilution
Number of shares on balance sheet date
Before dilution 28 674 506 28 674 506 28 674 506
After dilution 28 674 506 28 674 506 28 674 506
Average number of shares
Before dilution 28 674 506 28 674 506 28 674 506
After dilution 28 674 506 28 674 506 28 674 506
AroCell Q 1 2017 report FINAL

--
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

AroCell AB: (publ) Year-End Report


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 seewww.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 shareholderShares    Votes %
Name2016-12-31
FÖRSÄKRINGSAKTIEBOLAGET, AVANZA PENSION    3 373 88911,77%
TRIBUKAIT, BERNHARD    1 236 7964,31%
STAFFAN ERIKSSON MED BOLAG    1 077 8623,76%
NORDNET PENSIONSFÖRSÄKRING AB       798 2072,78%
JON EIKEN       650 0002,27%
GUNVALD BERGER       634 8522,21%
OLLE STENFORS       540 0001,88%
UBS SWITZERLAND AG /CLIENTS ACCOUNT       497 5291,74%
SWEDBANK       351 2101,22%
HÅKAN ENGLUND MED BOLAG       341 4781,19%
Övriga   19 172 68366,86%
Total28,674,506100,00%

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

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Source: AroCell AB via Globenewswire