In 2019, AroCell's subsidiary IDL Biotech began a collaboration with ZECEN Biotech regarding automation of the TPS® tumor marker on all of ZECEN Biotech's automated systems. The project has proceeded well and therefore a commercial agreement has now been concluded.

The registration process has now begun with The National Medical Products Administration (NMPA) in China, former CFDA, and the product is planned to be available in the Chinese market by the end of 2022.
“The development project with ZECEN Biotech has been very successful and we are now pleased to be able to conclude this agreement which gives us access to their automated platforms to reach the major hospitals in China. This is an important step in our strategy to focus on near-patient rapid tests, as well as automation of our products,” says Anders Hultman, AroCell's CEO.

According to the agreement, ZECEN Biotech will pay a royalty to AroCell based on sales in China. Several factors will affect revenue. These factors are uncertain and at this stage prevent us from predicting future revenues.

About TPS®
TPS® is a sensitive biomarker that is primarily used in the follow-up of metastatic breast cancer. TPS® has also been documented for other cancers, such as prostate and ovarian cancer. TPS® is an activity marker that measures soluble fragments of cytokeratin 18, which are overexpressed in epithelial cells. By following the patient with TPS® analyzes, both during treatment and follow-up, the clinician can obtain critical information about ongoing tumor activity and thus detect recurrences earlier. The tumor marker is a reliable indicator of tumor cell activity that is particularly useful in-patient management for various malignant tumors.

About ZECEN Biotech
ZECEN Biotech Co., Ltd., is a company that primarily specializes in providing total solutions of chemiluminescence immunoassay by developing, manufacturing, and marketing CLIA instruments and reagents. The company collaborates with leading hospitals in China and, in addition to customers in the domestic market, also has customers in South Asia, South America, East, and Southern Europe in the international market. The company has research and development centers and a production base in Beijing, Shandong, and Jiangsu. ZECEN Biotech Co., Ltd., was founded in 2011 and currently has about 1,400 automated systems located in China.

Summary

• Each existing share in the Company held on the record date 26 January 2022 entitles to one (1) subscription right. One (1) subscription right entitle to subscription of one (1) new share, i.e., a subscription ratio of 1:1.
• The subscription price is SEK 0.75 per new share, which, assuming the Rights Issue is fully subscribed, results in the Company receiving issue proceeds of approximately SEK 86 million before deduction of transaction costs.
• The record date for the Rights Issue is 26 January 2022 and the subscription period runs from and including 31 January 2022 up to and including 14 February 2022.
• The last day of trading in the AroCell share including the right to participate in the Rights Issue is 24 January 2022.
• The Company has received subscription commitments and has entered into agreements on guarantee commitments of approximately SEK 86 million, which secures the Rights issue up to 100 percent.
• The Company intends to publish a prospectus regarding the Rights Issue around 26 January 2022.

Background and reason for the Rights Issue
The Board of Directors in AroCell assesses that the existing working capital is not sufficient to finance the Company’s capital needs and the commitments specified below for the coming twelve-month period. AroCell is now carrying out the Rights Issue, which if fully subscribed can provide the Company with approximately SEK 86 million, before deductions for issue costs. The expected net proceeds from the Rights Issue will, in the following order of priority and with an approximate proportion indicated in percentages, be used for:

• Approximately 15 percent of the net proceeds will be used for sales and marketing activities.
• Approximately 40 percent of the net proceeds will be used for the FDA approval process for UBD Rapid and AroCell TK 210 ELISA in the US.
• Approximately 25 percent of the net proceeds will be used for the IVDR approval process for UBC Rapid 2.0 and TK 210 ELISA in Europe.
• Approximately 13 percent of the net proceeds will be used for product development.
• Approximately 7 percent of the net proceeds will be used for repayment of a conditional shareholder contribution from Labbex Förvalnings AB.

Terms of the Rights Issue
Those who are registered as shareholders on the record date, 26 January 2022, have the preferential right to subscribe for new shares in the Rights Issue in relation to the number of shares held on the record date. One (1) existing share in the Company entitles to one (1) subscription right. One (1) subscription right entitle to subscription of one (1) new share, i.e., a subscription ratio of 1:1. In addition, investors are offered the possibility to subscribe for shares without subscription rights.

The subscription price is SEK 0.75 per new share. Provided that the Rights Issue is fully subscribed, the share capital will increase by a maximum of SEK 11,461,313.30 by a new issue of a maximum of 114,613,133 new shares, meaning that the share capital after the Rights Issue will amount to SEK 22,922,626.60 distributed by 229,226,266 shares. In the event of full subscription, the Rights Issue will provide AroCell with approximately SEK 86 million before deduction of issue costs. Shareholders who choose not to participate in the Rights Issue will, provided that the Rights Issue is fully subscribed, have their ownership diluted by approximately 50 percent, but are able to financially compensate for this dilution by selling their subscription rights.

Subscription of shares shall take place during the period from and including 31 January 2022 to and including 14 February 2022. The board has the right to extend the subscription and payment period. A possible extension of the subscription period shall be announced by press release no later than the last subscription day in the Rights Issue, i.e. 14 February 2022. Trading in subscription rights takes place on Nasdaq First North Growth Market during the period from and including 31 January 2022 to and including 9 February 2022 and trading in paid subscribed shares (Sw. Betalda tecknade aktier) during the period from and including 31 January 2022 until the Rights Issue has been registered with the Swedish Companies Registration Office (Sw. Bolagsverket).

Subscription commitments and guarantee commitments
AroCell has received subscription commitments from a selection of the Company's larger existing shareholders, amounting to approximately SEK 20.1 million, corresponding to approximately 23.4 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments in the form of a so-called bottom guarantee of approximately SEK 55.0 million, corresponding to approximately 64.0 percent of the Rights Issue, and a so-called top guarantee of approximately SEK 10.8 million, corresponding to approximately 12.6 percent of the Rights Issue. The bottom guarantee ensures, provided that subscription corresponds to at least the subscription commitments, that approximately 87.4 percent of the Rights Issue is subscribed and paid for. Through the top guarantee, provided that subscription corresponds to at least the subscription commitments and the bottom guarantee, that 100 percent of the Rights Issue is subscribed and paid for.

For the guarantee commitments, compensation is paid either in cash or in the form of newly issued shares in the Company. The subscription price for any shares issued to guarantors shall correspond to 90 percent of the volume-weighted average share price (VWAP) for the Company's share on Nasdaq First North Growth Market during the subscription period in the Rights Issue (i.e. during the period 31 January – 14 February 2022), however no lower than the subscription price in the Rights Issue.

Prospectus
Full terms and conditions for the Rights Issue, as well as other information about the Company and information about subscription commitments and guarantee commitments will be presented in the prospectus that the Company is expected to publish around 26 January 2022 (the "Prospectus").

Preliminary timeline for the Rights Issue

Extraordinary General Meeting
The Board has today decided to summon to an Extraordinary General Meeting on 19 January 2022. A formal notice of the Extraordinary General Meeting will be announced by AroCell in the near future.

Advisers
Redeye AB acts as financial adviser and Wigge & Partners Advokat KB acts as legal adviser in connection with the Rights Issue. Nordic Issuing acts as issuing agent in connection with the Rights Issue.

IMPORTANT INFORMATION
The information in this press release does not constitute an offer to acquire, subscribe or otherwise trade in shares, subscription rights or other securities in AroCell. No action has been taken and measures will not be taken to allow an offer to the public in any jurisdiction other than Sweden. The invitation to interested persons to subscribe for shares in AroCell will only be made through the Prospectus, which the Company intends on publishing around 26 January 2022.

Neither subscription rights, paid subscribed shares ("BTA") nor newly issued shares have been recommended or approved by any US federal or state securities authority or regulatory authority. No subscription rights, BTAs or newly issued shares have been registered or will be registered under the United States Securities Act of 1933 in its current wording, or under any other applicable law in the United States, Australia, Hong Kong, Japan, Canada, New Zealand, Switzerland, Singapore, South Africa or in any other country where the Rights Issue or Private Placement or distribution of the press release is contrary to applicable laws or regulations or requires that further prospectuses be prepared, registered or that any other measure is taken in addition to what is required by Swedish law. Accordingly, the press release, as well as the prospectus, application form and other documents attributable to the Rights Issue and Private Placement, may not be distributed to or within any such jurisdiction.

This announcement may include forward-looking statements, which are based on AroCell’s current expectations and projections about future events and financial and operational development. Words such as “intends”, “will”, “expects”, “anticipates”, “may”, “plans”, “estimates”, and other expressions that imply indications or predictions of future developments or trends, constitute forward-looking information. Forward-looking information is inherently associated with both known and unknown risks and uncertainties as it depends on future events and circumstances. Forward-looking information does not constitute a guarantee of future performance or development and actual results may differ materially from what is expressed in forward-looking information.

This information, the opinions, and forward-looking statements contained in this announcement, are applied only at this date and are subject to change without notice. AroCell makes no commitments to disclose updates or revisions to forward-looking information, future events or similar circumstances, other than as required by applicable law

This English announcement is an unofficial translation of the original Swedish announcement. In case of any discrepancies between the Swedish announcement and the English translation, the Swedish announcement shall prevail.

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)

“The new AroCell has a broad product portfolio with products that are established and used in healthcare today and which have great growth potential. The company has extensive knowledge and experience in biomarkers for oncology, especially urological cancer. The products include rapid tests as well as ELISA kits and biomarkers on automated platforms", says Anders Hultman, AroCell´s CEO, and continues, "The strengthening of resources and know-how that has now been added to the company gives us great opportunities to increase sales of the existing product portfolio as well as to vigorously pursue our development programs”.

In the evaluation and review process, AroCell has identified several main areas that form the basis of the company's strategy. These areas are summarized in the points below:

1. In the short/medium term, invest further in increasing sales volumes for existing products through more targeted sales efforts and focused resources.
2. Implement a clinical development program in oncology to obtain market approval in the United States and Europe for UBC® Rapid 2.0 and TK 210 ELISA.
3. Evaluate and utilize the synergy in clinical decision-making by combining TK1 and cytokeratins.
4. Focus on rapid tests for the company's biomarkers.
5. Invest additional resources to make the company's biomarkers available on automated platforms.

“AroCell's deep knowledge of TK1 in combination with the acquired knowledge of cytokeratin provides great opportunities to create conditions for better cancer care. We see great potential in the use of the biomarkers individually and believe that a combination of the markers can provide completely new opportunities. AroCell now has an operational opportunity to pursue this further", says Claes Post, AroCell's Chairman of the Board.

1. In the short/medium term, invest further in increasing sales volumes for existing products through more targeted sales efforts and focused resources.

AroCell will expand its sales efforts of the company's existing products and sees significant opportunities to increase sales volumes in our oncology segment, both in the already established German market and in other European countries. The Covid-19 pandemic and its restrictions have caused great difficulties in conducting sales activities on site. As the restrictions are eased, the company will increase its sales efforts. In Europe, we are already seeing a rapid recovery in sales.

In bacteriology, with our product TUBEX® TF for diagnosing typhoid fever, we currently have our main market in Indonesia. During the pandemic, we have continued our work to increase the processing of new markets and believe that we will be able to establish the product in new markets in Africa in the near future.

2. Implement a clinical development program in oncology to obtain market approval in the United States and Europe for UBC® Rapid 2.0 and TK 210 ELISA.

AroCell has an extensive clinical program, intending to bring the company's products to the US market and get the products approved following the new IVDR regulations in Europe. In the field of bladder cancer, we plan to start studies in the United States and Europe for UBC® Rapid 2.0, which is a new improved rapid test. The goal is to get approval according to 510(k) and to meet the requirements according to IVDR. This will enable an establishment in the US market, while we can increase sales in Europe with a new improved rapid test. In prostate and breast cancer, we also aim to conduct further studies in the United States and Europe with TK 210 ELISA. The next step is to conduct a pre-submission meeting with the FDA to be able to proceed with the studies in the United States. In parallel, the company plans for European studies to meet the requirements of IVDR.

3. Evaluate and utilize the synergy in clinical decision-making by combining TK1 and cytokeratins.

AroCell has a deep knowledge of TK1 and cytokeratins. We know that these biomarkers work well when used individually and see a great opportunity in using these together to increase diagnostic precision. The assessment is that it would provide an improved test to be able to detect metastatic cancer, recurrence of cancer, or early therapy response. AroCell has started a project to evaluate the synergy of combining the two biomarkers.

4. Focus on rapid tests for the company's biomarkers.

AroCell has extensive experience in the development of rapid testing, which is an important prerequisite for driving product development and the product strategy for AroCell forward. The company currently has an established sale of rapid tests to private clinics in the German market, where we also see great growth potential. The company estimates that the Covid-19 pandemic has increased public acceptance of the use of rapid tests. We expect this development to continue and may increase further as remote care expands. Allowing cancer patients to themselves get an indication, via rapid tests, of whether the disease has returned is an important part of this. The company sees this as a strategically important segment and the goal is for the entire product portfolio to be available as rapid tests.

5. Invest additional resources to make the company's biomarkers available on automated platforms.

To make AroCell's biomarkers available on a large scale, the company needs to establish collaborations with more in vitro diagnostic companies with automated platforms. By out-licensing the company's antibodies and technologies to IVD companies that have automated analysis instruments and a broad customer base, the cost of each analysis can be reduced. This stimulates use and gives larger volumes. AroCell currently has collaborations with several actors and will work actively to start new collaborations while we pursue the existing projects.

A video with the CEO's comments about the strategy will be available online from 10:00 on AroCell.com and Redeye.se.

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)

The reason why it hasn't been possible to find a predicate device for AroCell TK 210 ELISA in this 510(k) application and regulatory process is that the intended use is innovative and something similar is not on the market. This at the same time makes the product unique as it will meet a need where there is no product today.
 
"From a regulatory perspective, it was surprising to receive this information so late in the process. At the same time, the FDA has announced that they want to continue the dialogue regarding the product after we have now withdrawn this application. This is unusual but also positive as it enables us to analyze and map the way forward more quickly." says Peter Löwendahl, Senior Director Regulatory Affairs and continues, "The likely way forward is to apply for product approval according to the De Novo process. We intend to investigate this further and plan our continued activities regarding the indication of breast cancer".
 
"We have had a good and constructive dialogue with the FDA. AroCell TK 210 ELISA is a unique product with great potential in several different applications and indications. Our goal is that TK1 will become an integral part of cancer care." says Anders Hultman, CEO and continues, "The company is in an exciting phase and stands strong with several launched products and products under development as well as the opportunity for expansion into additional markets."
 
AroCell has a clear regulatory strategy for TK1 in the US. The goal is to gradually seek approval for the use of AroCell TK 210 ELISA for various cancer indications as new clinical data are generated. This is the starting point for AroCell's clinical program. The dialogue with the FDA regarding the indication of breast cancer will continue as described above. In line with the established strategy, the aim is to make several 510(k) applications in other indications such as for example prostate cancer.

The AroCell TK 210 ELISA kit can now be used for measuring TK1 as a prognostic/predictive marker in prostate cancer in clinical and hospital laboratories to aid oncologists when stratifying patients for treatment.

The CE-mark is a certification mark that indicates conformity to the directive for a product in Europe’s internal market (EU/EES). This is a major step in increasing the future market potential and sales of the AroCell TK 210 ELISA kit for clinical use in Europe.

“We are happy to be able to make this extension of the indication for use for the CE marked AroCell TK 210 ELISA, which makes it possible to use AroCell TK 210 ELISA for prostate cancer. This is part of our regulatory strategy for Europe, to expand the intended use based on clinical data” says Anders Hultman, CEO of AroCell.

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)

Due to the sustained volume of EUA (Emergency Use Authorization) requests and the continued importance of testing in the response to the pandemic, FDA delayed all the submission reviews, which now are resumed.

“We are excited about this news. This is an important step for future commercial success in US for AroCell. Clearance of the 510(k) for AroCell TK 210 ELISA will make the product available for clinical testing of patient samples and is an important step for market penetration in US”, says Anders Hultman, CEO of AroCell.

The Food and Drug Administration'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). Due to the on-going national emergency and the large number Emergency Use Authorization (EUA) requests, FDA have received for in vitro diagnostics (IVDs), staff and managers have been reallocated to complete the review of these requests. This has caused a delay in handling of other 510(k) submissions. The review of AroCell´s 510(k) submission will be resumed no later than April 15th 2021.
 

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)

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). They state that due to the sustained volume of EUA (Emergency Use Authorization) requests and continued importance of testing in the response to the pandemic, they are not yet able to resume the review of submissions.

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

Former CFO Anders Hultman has been appointed new CEO. During the more than two years he has been at AroCell, Anders has done an exceptional job together with the former CEO Michael Brobjer, which enables a simple and smooth transition to the new role. Anders is very well acquainted with the company's strategies and plans to take the AroCell TK 210 ELISA to the next level. In addition to a solid experience as CFO, Anders has the business acumen needed for a demanding CEO assignment. He has previous experience of successfully running both listed and unlisted companies in various industries.

"I am honored to take over as CEO after Michael Brobjer. AroCell has a fantastic product and is in an important and interesting phase where full focus is on the strengthened commercialization of AroCell TK 210 ELISA. I look forward to leading AroCell to the next phase together with our professional team ", says CEO Anders Hultman.

Former CEO Michael Brobjer has resigned at his request. He and his family are going on a longer sailing voyage. Michael resigns today as CEO and thus enables a smooth transition for the new CEO Anders Hultman. During the remaining time at the company, Michael will focus on the launch of AroCell TK 210 ELISA in the US prior to the FDA approval of AroCell's 510(k) submission. Michael will work his last day at AroCell on April 30th  but will continue as a consultant for AroCell.

"I look forward with great excitement to AroCell's continued journey and am convinced of its success. At the same time, I am on my way to the adventure of my life, something that we in the family promised each other many years ago. It will be very exciting to follow AroCell's continued development from the oceans ", says former CEO Michael Brobjer.

“Michael Brobjer has made a great contribution to AroCell and through his leadership taken the company to a new level. I am pleased that through the appointment of Anders Hultman, we can confidently ensure that AroCell continues to pursue its successful work to offer a better tool to support oncologists in the treatment of cancer while placing further focus on our US launch," said Claes Post, Chairman of the Board at AroCell.