A word from the CEO
”During the summer, we completed the acquisition of IDL Biotech and have now created a joint organization with a new strategy. This will take advantage of the two companies' strengths and thus utilize the companies' synergies in several areas. This report for the third quarter is the first interim report covering the merged company.

Happily, we now see, as markets begin to open up after the pandemic, a rapid recovery in our oncology segment with an "all-time high" in sales in Germany. At the same time, we hope to be able to open new markets for our bacteriology product TUBEX® TF. In parallel with this, planning is underway for future clinical studies that will form the basis for several approvals for our products in new markets”.

Anders Hultman, CEO

Reporting period July 1st – September 30th

• Net sales amounted to 6,029 (0) KSEK
• Profit after financial items amounted to -18,950 (-6,371) KSEK
• Cash flow from operating activities for the period amounted to -7,180 (-5,580) KSEK
• Earnings per share before and after dilution amounted to -0.16 (-0.08) SEK

Reporting period January 1st - September 30th
Please note that IDL Biotech is only included in the third quarter.

• Net sales* amounted to 6,102 (64) KSEK
• Profit after financial items amounted to -31,757 (-18,040) KSEK
• Cash flow from operating activities for the period amounted to -18,880 (-15,068) KSEK
• Earnings per share before and after dilution amounted to -0.34 (-0.25) KSEK
• Cash and cash equivalents at the end of the period amounted to 27,825 (45,896) KSEK

*Net sales for the period including IDL Biotech correspond to 17,138 (16,242) KSEK.

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

• AroCell informed that the Offer to shareholders in IDL Biotech AB is unconditional and completes the offer and to extend the acceptance deadline until 9 August 2021.

• AroCell announced that after a discussion with the FDA, it has been concluded that the predicate device selected for the AroCell 510 (k) application is not possible given the intended use. Due to this, AroCell has decided to withdraw the 510 (k) application in its current form.

• AroCell announced the outcome of the Offer to shareholders in IDL Biotech AB. The offer was accepted by 98% of the shares and votes in IDL.

• AroCell's subsidiary IDL Biotech AB was listed from Spotlight Stock Market.

• AroCell's subsidiary IDL Biotech AB informed about compulsory redemption of IDL's remaining shares.

• AroCell announced that a patent application has been filed in the United States for the measurement of thymidine kinase 1, for the prediction of cancer recurrence based on serum TK1 levels. The patent application is based on a study of patients with diffuse large-cell B-cell lymphoma (DLBCL).

• AroCell announced a new publication entitled “Serum concentration of Thymidine kinase 1 measured using a novel antibody-based assay in patients with Hodgkin's Lymphoma”. The study showed that patients with Hodgkin's lymphoma had significantly higher TK1 concentration, and where TK1 increases with more severe disease category.

Events after the reporting period

• AroCell informed about the company's updated operational strategy following the acquisition of IDL Biotech AB. The company has established a joint office in Bromma so that the operations' strengths and areas of expertise are utilized optimally, and to vigorously develop and streamline the company.

• A new study was published that examined whether the concentration of thymidine kinase 1 (TK1) in the blood early shows whether cytotoxic drugs work or not. The measurements were made with AroCell's TK 210 ELISA. The article is authored by Bernhard Tribukait and was published in the journal Cancers, 2021.

Interim report January 1st – September 30th, 2021 (available in Swedish only) (Link)

A word from the CEO
”In July, AroCell AB acquired IDL Biotech AB, which develops and markets diagnostic tests for healthcare with a focus on oncology. This will be the last interim report for the original AroCell, with the next report covering both companies. We are now in the middle of an exciting and intense period where the two companies merge into a new, stronger AroCell.

The time since the last report has been very eventful and AroCell has made great progress, but also encountered some setbacks”.

Anders Hultman, CEO

Reporting period April 1st - June 30th

• Net sales were 30 (-) KSEK
• Loss before financial items was -6 727 (-6 195) KSEK
• Cash flow from operating activities was -5 185 (-4 419) KSEK
• Earnings per share before and after dilution were -0,09 (-0,08) SEK
• Cash and cash equivalents were at the end of the period 29 698 (51 428) KSEK

Reporting period January 1st - June 30th

• Net sales were 73 (64) KSEK
• Loss before financial items was -12 805 (-11 669) KSEK
• Cash flow from operating activities was -11 421 (-9 488) KSEK
• Earnings per share before and after dilution were -0,17 (-0,16) SEK
• Cash and cash equivalents were at the end of the period 29 698 (51 428) KSEK

Events during the reporting period January 1st - Mars 31st

• AroCell submitted a public takeover bid to the shareholders of IDL Biotech AB to transfer all shares in IDL (63,060,677) to AroCell in exchange for 0.63 AroCell shares for each share in IDL Biotech AB. The shares in IDL are listed on Spotlight Next ("Spotlight"). The issue of the consideration shares may comprise up to 39,728,226 shares in AroCell, corresponding to 34.4% of the shares and votes in AroCell after the issue of the consideration shares.

• A recently published doctoral dissertation deepens the knowledge about early detection, course, and prediction of treatment effects in prostate cancer. One of the sub-papers in the dissertation examines the extent to which the concentration of the enzyme Thymidine kinase 1 (TK1) in the blood can be used to predict whether the patient will die of prostate cancer.

• AroCell announced the extension of the indication for use of the CE marked AroCell TK 210 ELISA for clinical use in the treatment of prostate cancer. AroCell TK 210 ELISA can now be used to measure TK1 as a prognostic/predictive marker in local or widespread prostate cancer.

• The US Food and Drug Administration (FDA) has announced that they have resumed review of AroCell's 510(k) application following the impact of the relocation of resources due to the COVID-19 pandemic.

• AroCell published the prospectus regarding the publication of the takeover bid to the shareholders of IDL Biotech AB.

• AroCell announced that Professor Ferruccio Bonino will join AroCell's advisory board. Ferruccio Bonino, MD, is Professor of Gastroenterology at the University of Pisa, Department of Clinical and Experimental Medicine, and Senior Research Associate at IBB-CNR in Italy.

Events after the reporting period

• AroCell informed that the Offer to shareholders in IDL Biotech AB is unconditional and completes the offer and to extend the acceptance deadline until 9 August 2021.

• AroCell announced that after a discussion with the FDA, it has been concluded that the predicate device selected for the AroCell 510 (k) application is not possible given the intended use. Due to this, AroCell has decided to withdraw the 510 (k) application in its current form.

• AroCell announced the outcome of the Offer to shareholders in IDL Biotech AB. The offer was accepted by 98% of the shares and votes in IDL.

• AroCell announced that a patent application has been filed in the United States for the measurement of thymidine kinase 1, for the prediction of cancer recurrence based on serum TK1 levels. The patent application is based on a study of patients with diffuse large-cell B-cell lymphoma (DLBCL).

• AroCell announced a new publication entitled “Serum concentration of Thymidine kinase 1 measured using a novel antibody-based assay in patients with Hodgkin's Lymphoma”. The study showed that patients with Hodgkin's lymphoma had significantly higher TK1 concentration, and where TK1 increases with more severe disease category.

Interim report January 1st - Mars 31st, 2020 (available in Swedish only) (Link)

A word from the CEO
”I have now had the privilege of being the CEO of AroCell for "100 days". It has been and is an incredibly fun, intense, and eventful period. We have strengthened our organization, worked with commercialization in the United States. The FDA has resumed processing our 510(k) application. In more detail, we have expanded our clinical team, worked with the initiation of new clinical studies, and in addition to this, we have also recently submitted a public takeover bid for IDL Biotech AB. We see the merger with IDL as a unique opportunity for both companies to further develop the joint product portfolio and increase sales.”

Anders Hultman, CEO

Reporting period January 1st - Mars 31st

• Net sales were 43 (64) KSEK
• Loss before financial items was -6 078 (-5 474) KSEK
• Cash flow from operating activities was -6 235 (-5 068) KSEK
• Earnings per share before and after dilution were -0.08 (-0.08) SEK
• Cash and cash equivalents were at the end of the period 35 778 (55 847) KSEK

Events during the reporting period January 1st - Mars 31st

• Anders Hultman, the company's CFO, was appointed new CEO of Arocell. Former CEO Michael Brobjer has resigned at his request but will remain in the company until April 30 as CCO.

• AroCell announced that Jonas Söderholm has been recruited to the management team as Global Medical Lead. Jonas will lead and develop AroCell's clinical program with a focus on obtaining more clinical evidence for the use of TK1 as a biomarker in cancer treatment.

• FDA informs about further delays. The COVID-19 pandemic has led to the redeployment of FDA personnel, leading to further delays in reviewing FDA applications. The delay is extended by another 90 days.

• Gunnar Steineck was appointed as Chief Medical Officer at AroCell. Gunnar has until now been interim CMO but now has the role permanently. Gunnar has extensive experience as both an oncologist and clinical researcher.

• The FDA announced that they will resume the review of the AroCell 510(k) application by April 15, 2021.

• Staffan Eriksson joins AroCell's advisory board and thus leaves his position as CSO.

• The Nomination Committee proposed that AroCell's Board of Directors be expanded with one member at the 2021 Annual General Meeting through the election of Lotta Ljungqvist.

Events after the reporting period

• AroCell submitted a public takeover bid to the shareholders of IDL Biotech AB

• The FDA announced in April that they have resumed the review of AroCell's 510(k) application following the impact of relocation due to the COVID-19 pandemic.

• A recently published doctoral dissertation deepens the knowledge about early detection, course, and prediction of treatment effects in prostate cancer. One of the sub-works in the dissertation examines the extent to which the concentration of the enzyme Thymidine kinase 1 (TK1) in the blood can be used to predict whether the patient will die of prostate cancer.

Interim report January 1st - Mars 31st, 2020 (available in Swedish only) (Link)

The Annual report is available on the following link: https://arocell.com/sv/financial-report/
The report is available in Swedish only.
 

A word from the CEO
”2020 was a groundbreaking and eventful year for AroCell with high activity in many areas. Since Michael Brobjer took over as CEO in 2018, the management's goal has been to transform the company from a research-oriented company to a commercially driven company. In 2020, we have come a long way in reaching the goal and have strengthened the organization with additional expertise, and implemented our regulatory plan.

During the year, the company submitted a 510(k) application to the FDA where the goal is to obtain clearance to be able to sell AroCell TK 210 ELISA for clinical use in the US. We consider the approval in the US as a very important strategic step in spreading knowledge about the benefits of measuring TK1 and thus in the long run get the product to be used and generate revenue.”

Anders Hultman, CEO

Reporting period October 1st - December 31st

• Net sales were 20 (120) KSEK
• Loss before financial items was -6 012 (-6 034) KSEK
• Cash flow from operating activities was -3 834 (-3 787) KSEK
• Earnings per share before and after dilution were -0.08 (-0.15) SEK
• Cash and cash equivalents were at the end of the period 42 014 (13 631) KSEK

Reporting period January 1st - December 31st

• Net sales were 84 (443) KSEK
• Loss before financial items was -24 052 (-20 736) KSEK
• Cash flow from operating activities was -18 902 (-15 055) KSEK
• Earnings per share before and after dilution were -0.33 (-0.53) SEK
• Cash and cash equivalents were at the end of the period 42 014 (13 631) KSEK

Events during the reporting period October 1st - December 31st

• 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 that a new article has been 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.

• AroCell informed about the composition of the Nomination Committee before the 2021 Annual General Meeting.

Events after the reporting period

• Anders Hultman, the company's CFO, was appointed new CEO of AroCell. Former CEO Michael Brobjer has resigned at his request but will remain in the company until April 30 as CCO.

• AroCell announced that Jonas Söderholm has been recruited to the management team as Global Medical Lead. Jonas will lead and develop AroCell's clinical program with a focus on obtaining more clinical evidence for the use of TK1 as a biomarker in cancer treatment.

• FDA informs about further delays. The COVID-19 pandemic has led to the redeployment of FDA personnel, leading to further delays in reviewing FDA applications. The delay is extended by another 90 days.

• Gunnar Steineck was appointed as Chief Medical Officer at AroCell. Gunnar has until now been interim CMO but now has the role permanently. Gunnar has extensive experience as both an oncologist and clinical researcher.

Interim report January 1st - December 31st, 2020 (available in Swedish only) (Link)