A word from the CEO
” Our work to ensure a positive outcome of our 510(k) submission to the FDA and thus the opportunity to sell the AroCell TK 210 ELISA as an IVD product in the US market continues unchanged. We have had an active dialogue with the FDA regarding our submission and the work has progressed according to plan. However, the FDA announced in October that they had to make certain priorities, which meant that the review of our 510(k) submission would initially be postponed for 90 days. It is mainly the strained situation around Covid-19 that makes the FDA need to make these priorities. It is of course a disappointment for AroCell that there will be a delay in the process of clearance of our 510(k). The work of preparing for the launch of AroCell TK 210 ELISA with primarily reimbursement plans, market access strategy, and launch activities continues. Our assessment remains that we can obtain clearance of our AroCell TK 210 ELISA from the FDA no later than the end of 2021.”

Michael Brobjer, CEO

Reporting period July 1st - September 30th

• Net sales were 0 (120) KSEK
• Loss before financial items was -6 371 (-4 500) KSEK
• Cash flow from operating activities was -5 580 (-2 806) KSEK
• Earnings per share before and after dilution were -0,08 (-0,11) SEK
• Cash and cash equivalents were at the end of the period 45 848 (18 629) KSEK

Reporting period January 1st - September 30th

• Net sales were 64 (323) KSEK
• Loss before financial items was -18 040 (-14 702) KSEK
• Cash flow from operating activities was -15 068 (-11 268) KSEK
• Earnings per share before and after dilution were -0,25 (-0,37) SEK
• Cash and cash equivalents were at the end of the period 45 848 (18 629) KSEK

Events during the reporting period July 1st - September 30th

• A patent was granted by the Japanese Patent Office. The patent relates to AroCell's proprietary monoclonal antibodies used to determine the concentration of Thymidine kinase 1 in serum samples. These antibodies are used in AroCell TK 210 ELISA.

• A patent was granted by the European Patent Office (EPO). The patent relates to AroCell's proprietary monoclonal antibodies used to determine the concentration of Thymidine kinase 1 in serum samples. These antibodies are used in AroCell TK 210 ELISA.

• AroCell implemented a change in the company's management. Cecilia Ahlin ended her employment as Chief Medical Officer (CMO). Gunnar Steineck, professor of oncology, was appointed as interim CMO.

• AroCell initiated a new collaboration with the University of Rome la Sapienza to evaluate Thymidine kinase 1 (TK1) and PSA in response to biomarkers after hormone therapy in castration-resistant prostate cancer patients. The goal is to help physicians get better treatment data by measuring TK1 as a response biomarker in castration-resistant metastatic prostate cancer patients who have been treated with hormone therapy.

• AroCell has had a dialogue with the US Food and Drug Administration (FDA) regarding the 510 (k) submission that the company submitted on May 26, 2020.

Events after the reporting period

• The FDA reports delays in the timeline for reviewing 510(k) applications, due to a large number of Emergency Use Authorization (EUA) requests they have received in in-vitro diagnostics (IVDs) due to COVID 19. Redistributions of staff and resources are expected to affect the timeline for reviewing applications. The FDA estimates the delay at about 90 days, which will delay the review of AroCell's 510(k) application.

• AroCell announced a new article published in the Journal of Immunological Methods. The article indicates that it is possible to design diagnostic algorithms for biomarkers that can help distinguish Mycoplasma pneumonia from other respiratory infections caused by bacteria or viruses.

Interim report January 1st - September 30th, 2020 (available in Swedish only) (Link)

A word from the CEO
"The second quarter has been largely characterized by the Covid-19 pandemic and measures have been taken to prevent the spread of the virus. For AroCell, this has meant changes in office and laboratory procedures, no physical meetings with customers or partners, and a limited possibility for meetings with our clinical partners. This has of course affected our sales of AroCell TK 210 ELISA negatively but we are now seeing an increased number of contacts and interest in our product. However, the business has been able to continue with undiminished force and the focus has been on the submission of 510 (k) clearance to the FDA in the US and strengthening of our IP portfolio.”

Michael Brobjer, CEO

Reporting period April 1st - June 30th

• Net sales were 0 (127) KSEK
• Loss before financial items was -6 195 (-4 915) KSEK
• Cash flow from operating activities was -4 419 (-4 060) KSEK
• Earnings per share before and after dilution were -0.08 (-0.12) SEK
• Cash and cash equivalents were at the end of the period 51 428 (21 435) KSEK

Reporting period January 1st - June 30th

• Net sales were 64 (203) KSEK
• Loss before financial items was -11 669 (-10 202) KSEK
• Cash flow from operating activities was -9 488 (-8 462) KSEK
• Earnings per share before and after dilution were -0.16 (-0.26) SEK
• Cash and cash equivalents were at the end of the period 51 428 (21 435) KSEK

Significant events during the reporting period April 1st - June 30th

• A new peer-reviewed article has been published in the journal BioTechniques, where AroCell TK 210 ELISA shows higher sensitivity compared to other TK1 ELISA assays.

• AroCell filed an international (PCT) patent application regarding the use of Thymidine Kinase 1 (TK1) in predicting the presence of and diagnosing Mycoplasma pneumonia, and in the classification of respiratory infections.

• New peer-reviewed scientific article on TK1 has been published in the journal BMC Cancer. The results have shown that TK1 has the potential to be used as a biomarker for early treatment response in patients with breast cancer.

• In May, AroCell submitted an application to the US Food and Drug Administration (FDA) for 510 (k) clearance of the AroCell TK 210 ELISA kit.

• AroCell has extended the CE mark for AroCell TK 210 ELISA with clinical use in cancer treatment, such as breast cancer.

• AroCell has received a letter of approval from the European Patent Office (EPO) for the patent application for AroCell's proprietary monoclonal antibodies used in AroCell TK 210 ELISA.

• Two posters about TK1 and AroCell TK 210 ELISA have been presented and published online at the American Association of Cancer Research 2020 (AACR 2020).

Significant events after the reporting period

• The patent application for AroCell's proprietary monoclonal antibodies has been granted by the Japanese Patent Office.

• AroCell has announced the change in management. Cecilia Ahlin ended her employment as Chief Medical Officer and Gunnar Steineck, professor in oncology was appointed interim CMO.

• AroCell has initiated a new collaboration with the University of Rome la Sapienza to evaluate the role of Thymidine kinase 1 (TK1) and PSA as response biomarkers after hormone treatment in castration-resistant prostate cancer patients.

Interim report January 1st - June 30th, 2020 (available in Swedish only) (LINK)

A word from the CEO
“Like most other companies, AroCell has had challenges with the Corona pandemic. The measures all around the world that have been taken to prevent the spread of the virus have affected us all. For AroCell, this has meant fewer opportunities for meetings with our clinical partners and lower sales of our kit. However, internal operations have been able to continue without interruption. A major focus during this period has therefore been on strengthening our IP portfolio and on the work to get AroCell TK 210 ELISA approved by the FDA in the USA."

Michael Brobjer, CEO

Reporting period 1st January – 31st March 2020

• Net sales were 64 (76) KSEK
• Loss before financial items was -5 474 (-5 287) KSEK
• Cash flow from operating activities was -5 068 (-4 402) KSEK
• Earnings per share before and after dilution were -0.08 (-0.13) SEK
• Cash and cash equivalents were at the end of the period 55 847 (25 332) KSEK

Significant events during the reporting period 1 July – 31st March

• AroCell patent no 105980407 and titled “Monoclonal anti-TK1 antibodies” were granted by China National Intellectual Property Administration (CNIPA). The patent relates to AroCell’s proprietary monoclonal antibodies used for determining the Thymidine kinase 1 concentration in serum samples.

• AroCell patent no. 10.551.385 regarding the method of determining the likelihood of cancer relapse was granted by United States Patent and Trademark Office.

• Cecilia Ahlin joined the management team as Chief Medical Officer. Cecilia will lead and develop AroCell’s clinical strategy with a focus on getting more clinical evidence for the use of TK1 as a biomarker in cancer treatment.
• AroCell submitted a patent application regarding the use of an immunoassay of Thymidine Kinase 1 (TK1) to enable more accurate prognoses in prostate cancer patients. The patent is based on research together with the University of Tampere.

• AroCell initiated a collaboration with the University Hospital of Pisa to evaluate the AroCell TK 210 ELISA for Thymidine Kinase 1 (TK1) as a prognostic biomarker in subjects with liver cancer. The aim of the study is to determine the prognostic value of TK1 in combination with imaging techniques to improve prognoses and monitoring in subjects with liver cancer

• An abstract from AroCell was accepted for poster presentation on the American Association of Cancer Research 2020 (AACR 2020).

• A new peer-reviewed article from AroCell was accepted for publication in the BioTechniques journal. The article describes a comparison of AroCell TK 210 ELISA with Abcam TK1 ELISA.

• Marianne Alksnis was employed as Senior Sales Director. Marianne will be leading Arocell's sales efforts and continue to develop the global distributor network.

Significant events after the reporting period

• A new peer-reviewed article was published in the BioTechniques journal, were AroCell TK 210 ELISA shows higher sensitivity compared to other TK1 ELISA assays

• AroCell AB filed an international (PCT) application at the Swedish Patent Office (PRV) regarding the use of Thymidine kinase 1 (TK1) in predicting the presence of and diagnosing Mycoplasma pneumonia, and in the classification of respiratory infections.

Interim report January 1st to March 31st, 2020 (available in Swedish only) (Link)

The Annual report is available on the following link: arocell.com/årsredovisning-2019

The report is available in Swedish only.

This information was submitted for publication through the agency of Michael Brobjer, April 3, 2020, at 10:30.

For more information:
Michael Brobjer, CEO
Telephone: +46(0)18 50 30 20
E-mail: michael.brobjer@arocell.com

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 Thymidine Kinase 1 (TK1) protein concentrations in a blood sample. The TK 210 ELISA test provides valuable information mainly about the condition of cancer patients. This may help clinicians to optimize treatment strategies and estimate the risk of recurrence of tumor disease during the monitoring of the disease. AroCell (AROC) is listed at Nasdaq First North Growth Market with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. For more information; www.arocell.com

A word from the CEO
“In 2019, AroCell has been transformed from a research-oriented company to a commercially oriented company. The change began at the turn of the year and is now evident in all our operations. At the same time, there is much left work to do and we continue to be a little better at everything we do. But when I look back on this year, I can see that AroCell
stands much stronger now than a year ago, and that on all fronts. I said when I started a year ago that we would improve communication to the market, increase sales and build value for the company. We have in all of these points come a good bit further. Mainly because several clinical studies have been started, more distributors have been contracted and we have participated in several different conferences and meetings where we were given the opportunity to present AroCell and our AroCell TK 210 ELISA.”

Michael Brobjer, CEO

Reporting period 1st October – 31st December 2019

• Net sales were 120 (0) KSEK
• Loss before financial items was -6 034 (-5 462) KSEK
• Cash flow from operating activities was -4 998 (-4 854) KSEK
• Earnings per share before and after dilution were -0.15 (-0.14) SEK
• Cash and cash equivalents were at the end of the period 13 631 (29 734) KSEK

Reporting period 1st January – 31st December 2019

• Net sales were 443 (782) KSEK
• Loss before financial items was -20 736 (-20 757) KSEK
• Cash flow from operating activities was -16 103 (12 485) KSEK
• Earnings per share before and after dilution were -0.53 (-0.59) SEK
• Cash and cash equivalents were at the end of the period 13 631 (29 734) KSEK

Significant events during the reporting period October 1st – December 31st

• AroCell had a pre-submission meeting with the FDA for the clearance of the product AroCell Tk 210 ELISA. The path to FDA clearance was discussed and defined. The aim of the meeting was to ensure that there was a common view of the documentation needed for the application.

• AroCell performed an issue of shares with preferential rights for existing shareholders of SEK 39.4m as well as a directed share issue of SEK 15m. 55 per cent of the rights issue, was subscribed for by the exercise of subscription rights (including subscription undertakings). Furthermore, approximately 5 per cent of the rights issue was subscribed for without subscription rights. The issues will fund the work of obtaining FDA approval of AroCell TK 210 ELISA in the US and thereof associated activities.

• AroCell initiated a collaboration with Tampere University Hospital (TAYS) to evaluate AroCell’s TK 210 ELISA for Thymidine Kinase 1 (TK1) as a prognostic biomarker in subjects with metastatic prostate cancer.

Significant events after the reporting period

• The AroCell patent no 105980407 and titled “Monoclonal anti-TK1 antibodies” was granted by China National Intellectual Property Administration (CNIPA). The patent relates to AroCell’s proprietary monoclonal antibodies used for determining the Thymidine kinase 1 concentration in serum samples.

• The AroCell patent no. 10.551.385 regarding the method of determining a likelihood of cancer relapse was granted by the United States Patent and Trademark Office.

• Cecilia Ahlin was employed as Chief Medical Officer. Cecilia will lead and develop AroCell’s clinical strategy with focus on getting more clinical evidence for the use of TK1 as a biomarker in cancer treatment

• AroCell submitted a patent application regarding the use of an immunoassay of Thymidine Kinase 1 (TK1) to enable more accurate prognoses in prostate cancer patients. The patent is based on research together with the University of Tampere.

• AroCell initiated a collaboration with the University Hospital of Pisa to evaluate the AroCell TK 210 ELISA for Thymidine Kinase 1 (TK1) as a prognostic biomarker in subjects with liver cancer. The aim of the study is to determine the prognostic value of TK1 in combination with imaging techniques to improve prognoses and monitoring in subjects with liver cancer.

• An abstract from AroCell was accepted for poster presentation on the American Association of Cancer Research 2020 (AACR 2020) to be held April 24-29 in San Diego, California, USA.

Year-End Report January 1st to December 31st, 2019 (available in Swedish only) (LINK)