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)

FDA’s Center for Devices and Radiological Health (CDRH) has been actively engaged in responding to the current pandemic caused by a novel coronavirus (SARS-CoV-2) and the associated disease it causes (COVID-19). And due to a large number of Emergency Use Authorization (EUA) requests that they have received for in vitro diagnostics (IVDs), and the reallocation of staff and resources are impacting the timeline for the reviews of submissions.

AroCell will receive updates regarding the anticipated timeline for the resources on the non-COVID related activities.

AroCell AB announced today that a dialogue has been held with the U.S. Food and Drug Administration (FDA) regarding the 510(k) submission that the company submitted on May 26, 2020. In the dialogue with the FDA, AroCell received questions regarding the 510(k) submission. AroCell intends to process the questions promptly and update the application within a few weeks.

"This type of dialogue with regulatory authorities is not uncommon when applying for 510(k). We have had a constructive dialogue with the FDA and we are now focusing on addressing the questions and updating the application in accordance with FDA recommendations," says Michael Brobjer, CEO of AroCell.

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)

“I am very pleased that Gunnar is taking on this position. His experience and knowledge in oncology and urology are very valuable for AroCell and Gunnar has previously made significant contributions in his role as a board member and in specific consulting assignments ", says Michael Brobjer, CEO of AroCell
 
At the same time, AroCell announces that it has agreed with the current CMO, Cecilia Ahlin, to end her employment at AroCell. Cecilia began her employment at AroCell on May 1 and has during the summer been on leave at her own request. We wish Cecilia all the best in her continued clinical work.

The AroCell TK 210 ELISA kit is to be used in clinical and hospital laboratories to aid oncologists in the early detection of treatment response when treating cancer patients; for example, breast cancer patients treated with chemotherapy.

The CE-mark is a certification mark that indicates conformity standard for a product in Europe’s internal market ( (EU/EES). This is a major step in increasing the market potential and sales of the AroCell TK 210 ELISA kit for clinical use in Europe.
 
“This extension of the CE-mark is in line with our regulatory strategy for Europe. We have now gathered enough clinical data to expand the intended use in the CE-mark. This is an important step for us, that gives us access to the clinical market in Europe.” says Michael Brobjer AroCell CEO.

An introduction to the US market through 510(k) clearance of the AroCell TK 210 ELISA is in line with the company's previously communicated strategy for expansion in the USA. Today's submission confirms that the plan for 510(k) clearance of AroCell TK 210 ELISA by the end of 2021 applies.

AroCell TK 210 ELISA is currently sold as Research Use Only (RUO) in the USA. With the clearance from the FDA, AroCell will be able to penetrate the much larger IVD market.

AroCell TK 210 ELISA is a quantitative immunoassay kit for the determination of Thymidine Kinase 1 (TK1) in human blood. The ELISA format is simple and robust, requires no special instrumentation to perform and can easily be incorporated into standard laboratory processes. By utilizing monoclonal antibodies specific for the TK1 epitope TK 210, AroCell TK 210 ELISA brings improved sensitivity and specificity to the assay of this key biomarker. AroCell TK 210 ELISA provides new opportunities for studying cellular proliferation, disruption, and monitoring of therapy response in cancer.

“I am impressed of what we have accomplished over such a short time, in less than five months we have collected all data needed for the application”, says Michael Brobjer, CEO of AroCell, and continues; “The submission for 510(k) and the subsequent clearance in the USA is a large step for our company. We are now preparing for the market launch together with our partners in the USA.”

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 medically most important mycoplasma infection is a lower tract respiratory infection caused by Mycoplasma pneumoniae, which is an atypical bacterial pneumonia, referred to as Mycoplasma pneumonia. It is estimated that in the United States about two million cases occur each year and M. pneumoniae infections accounts for 1-10 out of every 50 cases of community-acquired pneumonia. It is therefore generally considered as a major health problem worldwide.

The patent application is based on a study indicating that respiratory infections caused by Mycoplasma pneumoniae, in particular Mycoplasma pneumonia, lead to significantly increased levels of thymidine kinase 1 (TK1) protein, in particular serum TK1 (STK1) protein, in human patients. Such an increase in STK1 protein levels is, however, not seen in healthy humans or in patients suffering from respiratory infections caused by other pathogens, e.g., viral pneumonia.

“This patent application opens up a new area for using TK1 besides oncology. We have been evaluating the use of TK1 connected to infectious diseases for some time and have now enough data to protect our findings which can generate new possibilities for AroCell and health care providers by facilitating detection and classification of mycoplasma” says Michael Brobjer, CEO AroCell.

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)

The patent relates to AroCell’s proprietary monoclonal antibodies used for determining the Thymidine kinase 1 concentration in serum samples. The antibodies approved in the patent is used in the AroCell TK 210 ELISA kit.

“We are delighted that this patent has been granted by China National Intellectual Property Administration. This reinforces our patent position in China and increases AroCell’s attractiveness as a business partner in Asia. We will continue to develop our portfolio of proprietary assets to further expand our business opportunities and to support our product AroCell TK 210 ELISA.” says Michael Brobjer, CEO AroCell.

The patent claims the method of determining a likelihood of cancer relapse in a subject who has completed cancer tumour surgery, radiotherapy treatment and/or chemotherapy treatment comprises contacting an antibody that binds specifically to a serum form of Thymidine kinase 1 (STK1) protein with a blood serum sample one to six months after completing the surgery and/or treatment, and before any cancer relapse has been detected.

“We are delighted that the U.S. Patent and Trademark Office has granted this patent. This reinforce our patent position in the U.S. and increases AroCell’s attractiveness as a business partner. We will continue to develop our portfolio of proprietary assets to further expand its business opportunities and to support our product AroCell TK 210 ELISA. ” says Michael Brobjer, CEO AroCell.

In the study, on which this patent application is based, TK1 protein levels were assayed with AroCell TK 210 ELISA in serum samples collected from subjects with newly diagnosed prostate cancer and compared with the extent and speed of disease progression over a period of 10 years. The study was executed in collaboration with the Prostate Research Center at Tampere University Hospital and coordinated by Professor Teemu Murtola of the Pharmacoepidemiology and Chemoprevention of Urological Cancer Research Group.

“Thymidine kinase 1 in serum predicted survival after prostate cancer diagnosis, demonstrating independent predictive value over established clinical risk factors. If confirmed in further and larger studies, this biomarker could be incorporated in prostate cancer risk stratification when selecting optimal treatment and surveillance schedule.” says Professor Teemu Murtola.

“Prostate cancer is one of the most common cancers in men and this patent strengthens AroCell’s position as a developer and promoter of novel biomarkers for monitoring cancer. The patent will reinforce our position and increases AroCell’s attractiveness as a business partner. We will continue to develop our proprietary portfolio to further expand our business opportunities.” says Michael Brobjer, CEO AroCell.

There is a recognized need for better prognostic tools in prostate cancer. For many men, the disease will take a benign course and therefore there is a need to avoid over-treating these patients while providing more accurate monitoring of those with active disease. This is especially important with the advent of new and more effective therapies for prostate cancer.