English Archives - Arocell TK 210 ELISA

The path to FDA clearance of its product AroCell TK 210 ELISA is defined after an oral meeting with FDA. The aim of the meeting was to ensure that there was a common view of the documentation needed for the application.

As previously has been communicated regarding the plans for a clearance and introduction to the US market a meeting with FDA was to be held to define the documentation needed for a successful process. AroCell has now had a pre-Submission meeting to ensure that there is a common view of the documentation needed for the submission. The meeting with the FDA confirmed that the requirements suggested by AroCell for the simpler application procedure 510 (k) can be used for the clinical indications AroCell intend to apply for.

This confirms that the previously announced plan for 510 (k) clearance of AroCell TK 210 ELISA and the expected clearance by the end of 2021 applies.

“The communication with FDA confirms that our internal plan is in line with the requirements for FDA clearance according to the 510 (k) pathway. This is an important step for future commercial success in USA. A clearance for the TK 210 ELISA will make the product available for clinical samples from patients and is an important step for market penetration in USA”, says Michael Brobjer, CEO AroCell

About Thymidine Kinase 1
Thymidine Kinase 1 (TK1) is a key enzyme in DNA precursor synthesis. It is upregulated during the late G1 phase and early S phase of the cell cycle and its presence in cells is an indicator of active cell proliferation. Increased levels of TK1 in the blood can indicate active cell proliferation as a consequence of abnormal cell turnover and cell disruption triggered by for example therapeutic agents.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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

NOT FOR DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, SWITZERLAND, SINGAPORE, SOUTH AFRICA OR NEW ZEALAND OR ANY OTHER JURISDICTION IN WHICH DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL.

Through the completed rights issue, AroCell AB (publ) (”AroCell” or the ”Company”) will receive proceeds amounting to approximately MSEK 39.4 before deduction of costs related to the rights issue. 14,329,800 shares, corresponding to approximately 55 per cent of the rights issue, were subscribed for by the exercise of subscription rights (including subscription undertakings). Furthermore, 1,387,266 shares were subscribed for without subscription rights, corresponding to approximately 5 per cent of the rights issue. 10,567,897 shares, corresponding to approximately 40 per cent of the rights issue, were subscribed for by guarantors.

AroCell will receive proceeds of approximately MSEK 39.4 through the rights issue before deduction of costs related to the rights issue.

”I would like to thank all current shareholders that have participated in the rights issue for their continued support and also give a warm welcome to all new shareholders. We are in a very exciting phase of AroCell’s development of strengthening the organisation to secure the work towards obtaining FDA-approval of AroCell TK 210 ELISA in the U.S.” Michael Brobjer, CEO of AroCell.

Mikael Lönn is after the new share issue one of the large shareholders in the company.

”AroCell's standardized blood test that can be used to improve cancer treatment is a very promising product for optimizing treatment strategies for patients. With a good basic research in the company and together with an already CE approved product, AroCell has the opportunity to significantly improve the treatment of patients and at the same time reduce costs. As a new large shareholder in the company, I look forward to follow and support AroCell in its journey toward FDA approval in the United States and full establishment of the product.” comments Mikael Lönn.

Notification regarding allocation
Allocation of shares has been made in accordance with the allocation principles described in the prospectus that was published in connection with the rights issue. A notification regarding allocation of shares subscribed for without subscription rights will be made by post of a contract note to each subscriber. Allocated shares subscribed for without subscription rights shall be paid for in accordance with the instructions in the contract note.

Directed issue
In connection to the rights issue the Company has also completed a directed issue of new shares with proceeds amounting to MSEK 15, which has been fully subscribed. See the separate press release from 22 October 2019 for more information regarding the directed issue of new shares.

Number of shares and share capital
Through the rights issue AroCell’s share capital is increased by SEK 2,628,496.30 by issuing 26,284,963 shares. Through the directed issue the Company’s share capital is increased by SEK 1,000,000 through issuing 10,000,000 shares. AroCell’s share capital will thus increase with the total amount of SEK 3,628,496.30 from SEK 3,942,744.50 to SEK 7,571,240.80. The number of shares will increase with in total 36,284,963 from 39,427,445 to 75,712,408. The subscription price was SEK 1.5 in both issues of new shares.

Trading in BTA
Trading in BTA (Sw: betald tecknad aktie) is currently taking place at Nasdaq First North Growth Market and will cease when the rights issue has been registered by the Swedish Companies Registration Office. BTA:s will then be converted to ordinary shares.

Advisers
Redeye AB acts as financial adviser and Fredersen Advokatbyrå AB acts as legal adviser in connection with the rights issue. Aqurat Fondkommission AB acts as issuer agent.

Important information
The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in AroCell in any jurisdiction, neither from AroCell nor from someone else. Any investment decision in connection with the Rights Issue must be made on the basis of all publicly available information relating to the Company. Such information has not been independently verified by the financial advisors. The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness. This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into Australia, Hong Kong, Japan, Canada, New Zeeland, Singapore, South Africa, the United States or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations. This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. A prospectus in Swedish regarding the Rights Issue described in this press release will be prepared and submitted to Swedish Financial Supervisory Authority (Sw. Finansinspektionen). Following the Swedish Financial Supervisory Authority’s approval and registration of the prospectus, the prospectus will be published and kept available at AroCell’s website.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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

AroCell announced today the presentation made at ESMO Asia of further discoveries from the PROMIX breast cancer study. Combining serum Thymidine Kinase 1 (sTK1) measurements with routine pathologic markers improved the predictive power of a cell loss metric for tumour response to neoadjuvant chemotherapy in breast cancer.

The findings presented today at ESMO in Singapore are a continuation of results derived from sTK1 analysis of the PROMIX breast cancer study. At this same meeting in 2017 Professor Tribukait showed that it was possible to quantitate cell death with sTK1 measurements. Further careful analyses have discovered cell loss metrics useful in assessing therapy response. The predictive power of the cell loss metric studied, improved when combined with existing, previously collected clinical data such as hormone receptor status and tumour origin as obtained by routine histopathology at the time of diagnosis of the tumour.

“Combining diagnostic information at hand and the results from the AroCell TK 210 ELISA test can help gauge response, giving an early indication of therapy effectiveness. This will allow improved personalization of therapies.” says Michael Brobjer, CEO of AroCell. “Clinicians have a lot of data to consider, but often lacking certainty and wishing for additional information. TK1 variations in blood have high correlation to abnormal cell death. With AroCell´s test we look forward to assist researchers and clinicians worldwide, contributing information regarding TK1 levels in blood to benefit clinical studies and patients.”

“This impressive post analysis work also shows that older studies with frozen samples preserved in blood banks may benefit greatly from individual TK1 assessments to gain further insights.” concludes Michael Brobjer.

Link to the Abstract: esmo.org

About ESMO Asia Congress 2019:
ESMO (European Society of Medicinal Oncology) Asia Congress is one of the most important global oncology conferences with about 3,700 participants from over 70 countries. This year, EMSO is held between 22 and 24 November 2019 in Singapore, and it is the fifth time the conference is held.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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

NOT FOR DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, SWITZERLAND, SINGAPORE, SOUTH AFRICA OR NEW ZEALAND OR ANY OTHER JURISDICTION IN WHICH DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL.

Today is the first day of the subscription period of AroCell AB:s (publ) (”AroCell” or the ”Company”) issue of shares with preferential rights for existing shareholders (the “Rights Issue”) in which the public is also able to subscribe.

The Rights Issue is carried out in order to finance the work towards obtaining a FDA approval of AroCell TK 210 ELISA in the US. Assuming full subscription of the Rights Issue, AroCell will receive SEK 39.4m before issue costs. The Rights Issue is covered by subscription commitments and guarantee commitments corresponding to 100% of the issue proceed.

The Rights Issue includes not more than 26,284,963 shares. Persons registered as shareholders in AroCell on the record date, 15 November 2019, have preferential rights to subscripe for new shares in the Rights Issue in proportion to their existing share holdings.

Three (3) existing shares in the Company entitle to subscription of two (2) new shares. For every one (1) existing share, two (2) subscription rights will be received. Three (3) subscription rights entitle to subscription of one (1) new share. The subscription price is SEK 1.50 per share. The public is also able to subscribe.

Comment from AroCell’s CEO, Michael Brobjer
“AroCell’s next important goal for the business is a FDA approval of AroCell TK 210 ELISA in the US. Through a considerable procurement of capital, we are now fully financed for the work on the US market. We welcome our faithful exisiting shareholders to continue supporting us in our strive to improve the medical treatment of cancer through subscription in the Rights Issue. With these words I would like to thank both new and existing shareholers for their belief in Arocell’s future possibilities.” – Michael Brobjer, CEO.

Preliminary timeline:

November 20 – December 2, 2019 – Trading in subscription rights
November 20 – December 4, 2019 – Subscription period
November 20, 2019 – Until the Rights Issue is registered at the Swedish Companies Registration Office – Trading in BTA (interim share)
December 9, 2019 – Disclosure of outcome of Rights Issue

Investor meetings
The Company will hold presentations at the following occasions:

November 25, 2019 – Shareholder’s Day Stockholm 2019 (Sw: “Stora Aktiedagen Stockholm 2019”)
December 3, 2019 – BioStock Live Stockholm

Additional investor meetings may be conducted throughout the subscription period. An invitation to these meetings will be presented on AroCell’s and Redeyes respective webpages.

Prospectus
The prospectus, containing the full terms and instructions, is available on the Company’s, the issuer agent’s and Redeye AB:s respective webpage (www.arocell.com, www.aqurat.se, www.redeye.se). Furthermore, subscription forms will be obtainable by contacting the issuer agent via telephone by dialing +46 8-684 05 800.

Advisers

Redeye Aktiebolag acts as financial adviser and Fredersen Advokatbyrå acts as legal adviser in connection with the Rights Issue.

Important information

The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in AroCell in any jurisdiction, neither from AroCell nor from someone else. Any investment decision in connection with the Rights Issue must be made on the basis of all publicly available information relating to the Company. Such information has not been independently verified by the financial advisors. The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness. This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into Australia, Hong Kong, Japan, Canada, New Zeeland, Singapore, South Africa, the United States or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations. This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. A prospectus in Swedish regarding the Rights Issue described in this press release will be prepared and submitted to Swedish Financial Supervisory Authority (Sw. Finansinspektionen). Following the Swedish Financial Supervisory Authority’s approval and registration of the prospectus, the prospectus will be published and kept available at AroCell’s website.

Forward-looking statements

This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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

AroCell announced today that the patent no. 15/357 762 and titled” Method for use of antibody-based test for the prediction of cancer relapse - all immunoassays against TK1 “ is granted by United States Patent and Trademark Office.

The patent describes the use of TK1 antibody-based test for prediction of early cancer progression and the likelihood of tumor recurrence. It is estimated based on the binding response of TK1 in clinical samples to antibodies.

“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.” Says Michael Brobjer, CEO AroCell.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. For more information; www.arocell.com

NOT FOR DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, SWITZERLAND, SINGAPORE, SOUTH AFRICA OR NEW ZEALAND OR ANY OTHER JURISDICTION IN WHICH DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL.

AroCell AB (publ) (”AroCell” or the ”Company”) publishes prospectus with regards to the issue of shares with preferential rights for existing shareholders (the “Rights Issue”) resolved by the Board of Directors on 22 October 2019, subject to approval by the Extraordinary General Meeting on 8 November 2019.

The prospectus has today on 15 November 2019 been approved and registered by the Swedish Financial Supervisory Authority and is available in Swedish on AroCell’s website, www.arocell.com. Assuming full subscription of the Rights Issue, AroCell will receive SEK 39,4m before issue costs. The Rights Issue is covered by subscription commitments and guarantee commitments from principal owners and new investors corresponding to 100% of the issue proceed.

In connection with the Rights Offering the Company will also carry out a directed issue of SEK 15m.

The new issues of shares are carried out primarily to finance the work towards obtaining an FDA approval of AroCell TK 210 in the US.

Advisers

Redeye Aktiebolag acts as financial adviser and Fredersen Advokatbyrå acts as legal adviser in connection with the issues.

Important information

The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in AroCell in any jurisdiction, neither from AroCell nor from someone else. Any investment decision in connection with the Rights Issue must be made on the basis of all publicly available information relating to the Company. Such information has not been independently verified by the financial advisors. The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness. This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into Australia, Hong Kong, Japan, Canada, New Zeeland, Singapore, South Africa, the United States or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations. This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. A prospectus in Swedish regarding the Rights Issue described in this press release will be prepared and submitted to Swedish Financial Supervisory Authority (Sw. Finansinspektionen). Following the Swedish Financial Supervisory Authority’s approval and registration of the prospectus, the prospectus will be published and kept available at AroCell’s website.
Forward-looking statements

This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. For more information; www.arocell.com

NOT FOR DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, SWITZERLAND, SINGAPORE, SOUTH AFRICA OR NEW ZEALAND OR ANY OTHER JURISDICTION IN WHICH DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL.

Today’s Extraordinary General Meeting in AroCell AB (publ) (“AroCell” or the “Company”) resolved to approve the Board of Directors’ resolution on an issue of shares with preferential rights for existing shareholders (the “Rights Issue”) and the Board of Directors’ resolution on a directed issue (the “Directed Issue”) (the “Issues of New Shares”).

Resolutions on approval of the Board of Directors’ resolutions on Issues of New Shares
The terms of the Rights Issue entitle persons registered as shareholders in AroCell on the record date, 15 November 2019, to receive two (2) subscription rights for each share. Three (3) subscription rights entitle to subscription of one (1) new share. In addition to this, investors are offered the possibility to subscribe for shares without subscription rights. The Rights Issue will result in an increase of the share capital with not more than SEK 2,628,496.30 through an issue of not more than 26,284,963 shares. The subscription price is SEK 1.50 per share.
For shareholders that do not participate in the Rights Issue the dilution effect will be approximately 40 percent (calculated as the number of new shares due to to the Rights Issue divided with the total number of shares in the Company after a fully subscribed Rights Issue).

The Directed Issue has been directed towards a limited number of Nordic qualified investors and will result in an increase of the share capital with not more than SEK 1,000,000 through an issue of not more than 10,000,000 shares at a subscription price of SEK 1.50 per share. The dilution effect for current shareholders, calculated after the Rights Issue, will be approximately 13 percent.

The total issue proceeds from the Issues of New Shares is circa SEK 54,4 million before deduction of issue costs. The subscription period in the Issues of New Shares runs from and including November 20, 2019 to and including December 4, 2019.

As previously communicated, the purpose of the Issues of New Shares is to obtain FDA approval of AroCell TK 210 ELISA for the US market seek reimbursement, and if necessary, carry out additional clinical study/studies to support the FDA application. AroCell also plans to complete a study of health economics and carry out market activities prior to product launch.

Preliminary timeline for the Directed Issue

November 13, 2019 – Last day of trading incl. preferential rights
November 14, 2019 – First day of trading excl. preferential rights
November 15, 2019 – Record date
November 20 – December 2, 2019 – Trading in rights
November 20 – December 4, 2019 – Subscription period
November 20, 2019 – Until the Rights Issue is registered at the Swedish Companies Registration Office – Trading in BTA (interim share)
December 9, 2019 – Disclosure of outcome of Rights Issue

Advisers
Redeye Aktiebolag acts as financial adviser and Fredersen Advokatbyrå acts as legal adviser in connection with the issues.

Important information
The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in AroCell in any jurisdiction, neither from AroCell nor from someone else. Any investment decision in connection with the Rights Issue must be made on the basis of all publicly available information relating to the Company. Such information has not been independently verified by the financial advisors. The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness. This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into Australia, Hong Kong, Japan, Canada, New Zeeland, Singapore, South Africa, the United States or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations. This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. A prospectus in Swedish regarding the Rights Issue described in this press release will be prepared and submitted to Swedish Financial Supervisory Authority (Sw. Finansinspektionen). Following the Swedish Financial Supervisory Authority’s approval and registration of the prospectus, the prospectus will be published and kept available at AroCell’s website.

Forward-looking statements
This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. For more information; www.arocell.com

“During the third quarter, the operational changes that was initiated at the turn of the year began to take effect which has resulted in that the level of activity has increased dramatically. 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.

During this quarter, AroCell has also taken the first step to secure financing until at least the end of 2021. The shareholders will decide on this at the Extraordinary General Meeting on November 8th. Depending on the shareholders’ approval, it will give us full funding to achieve the next important goal for the business, which is to obtain FDA approval of AroCell TK 210 ELISA. “

Michael Brobjer, CEO

Reporting period 1st July – 30th September 2019

Net sales were 120 (162) KSEK
Loss before financial items was -4 500 (-5 400) KSEK
Cash flow from operating activities was -2 806 (-4 620) KSEK
Earnings per share before and after dilution were -0.11 (-0.14) SEK
Cash and cash equivalents were at the end of the period 18 629 (34 587) KSEK

Reporting period 1st January – 30th September 2019

Net sales were 323 (782) KSEK
Loss before financial items was -14 702(-15 294) KSEK
Cash flow from operating activities was -11 268 (-11 554) KSEK
Earnings per share before and after dilution were -0.37 (-0.45) SEK
Cash and cash equivalents were at the end of the period 18 629 (34 587) KSEK

Significant events during the reporting period 1 July – 30 September

Results from the PROMIX study were made public. The study shows that Thymidine kinase 1 can be used for early detection of therapy response in the treatment of breast cancer. The study was conducted by collecting serum from 104 patients with newly detected localized breast cancer during a neoadjuvant Phase II trial. The concentration of TK1 in blood was measured with AroCell TK 210 ELISA.
AroCell initiated a collaboration with the Dana Farber Cancer Institute to evaluate AroCell TK 210 ELISA on patients treated with CDK4/6 inhibitors. The purpose of this study is to investigate the compliance of serum TK1 concentration and clinical response to treatment.
AroCell expanded the management team with Peter Löwendahl, Senior Director of Regulatory Affairs. Peter Löwendahl will lead and develop AroCell’s regulatory strategy focusing on the US market and FDA approval of AroCell TK 210 ELISA.
AroCell signed a distribution agreement with Diapharma Group of West Chester Ohio for the promotion and distribution of the AroCell TK 210 ELISA in the United States and Canada.
Redeye initiated analyst coverage and has published an analysis report of Arocell.

Significant events after the reporting period

The Board of Directors of AroCell has resolved, subject to approval by the Extraordinary General Meeting on an issue of shares with preferential rights for existing shareholders of SEK 39.4m as well as a directed share issue of SEK 15m The Rights Issue is covered by subscription commitments and guarantee commitments from principal owners and new investors corresponding to 100% of the issue proceeds. 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 prostate cancer.

Interim report January 1st to September 30th , 2019 (available in Swedish only) (LINK)

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. For more information; www.arocell.com

Early prediction of tumour response to therapy is essential for individualized treatment. A relationship has recently been found between pathologic response in breast cancer (BC) and a measure of cell loss based on serum levels of thymidine kinase 1 (sTK1) and tumour volume.

Abstract entitled “*Tumour response to neoadjuvant chemotherapy in breast cancer: Routine pathologic markers improve the predictive power of a cell-loss metric based on release of thymidine kinase 1 into blood*” will be presented by Bernard Tribukait at ESMO Asia Congress.

The purpose was to establish whether the predictive power of this cell-loss metric can be further improved by baseline tumour characteristics. The study included 58 women with localized BC received neoadjuvant epirubicin/docetaxel in six cycles, supplemented with bevacizumab in cycle three to six. And the cell-loss metric, defined as the ratio between sTK1 (ng/ml) and tumour volume (cm3), was obtained prior to and 48 hours after cycle two. The sTK1 was measured with AroCell TK 210 ELISA.

About Thymidine Kinase 1
Thymidine Kinase 1 (TK1) is a key enzyme in DNA precursor synthesis. It is upregulated during the late G1 phase and early S phase of the cell cycle and its presence in cells is an indicator of active cell proliferation. Increased levels of TK1 in the blood can indicate active cell proliferation as a consequence of abnormal cell turnover and cell disruption triggered by for example therapeutic agents.

About TK 210 ELISA
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 in to 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 and relapse in subjects with hematological and solid tumors.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. For more information; www.arocell.com

Available in Swedish only.

EJ FÖR DISTRIBUTION ELLER OFFENTLIGGÖRANDE, DIREKT ELLER INDIREKT, I ELLER TILL AUSTRALIEN, HONGKONG, JAPAN, KANADA, NYA ZEELAND, SCHWEIZ, SINGAPORE, SYDAFRIKA, USA ELLER ANNAN JURISDIKTION I VILKEN DISTRIBUTION ELLER OFFENTLIGGÖRANDE AV DETTA PRESSMEDDELANDE SKULLE VARA OLAGLIG ELLER KRÄVA REGISTRERINGSÅTGÄRDER ELLER ANDRA ÅTGÄRDER UTÖVER DEM SOM FÖLJER SVENSK RÄTT. ANDRA RESTRIKTIONER ÄR TILLÄMPLIGA. SE VIKTIG INFORMATION I SLUTET AV PRESSMEDDELANDET.

KALLELSE TILL EXTRA BOLAGSSTÄMMA i AROCELL AB (publ)

Aktieägarna i AroCell AB (publ) kallas härmed till extra bolagsstämma den 8 november 2019 kl. 11.00 i lokalen Bergman i Uppsala Business Park, Virdings allé, 32 B, 754 50 Uppsala. Registreringen börjar kl. 10.30 och avbryts när stämman öppnas.

Rätt till deltagande Rätt att delta i bolagsstämman har den som dels upptagits som aktieägare i den av Euroclear Sweden AB förda aktieboken avseende förhållandena den 1 november 2019, dels senast den 1 november 2019 till bolaget anmäler sin avsikt att delta i den extra bolagsstämman. Anmälan kan ske skriftligen till AroCell AB, c/o Fredersen Advokatbyrå AB, Turning Torso, 211 15 Malmö samt via e-post till arocell@fredersen.se. Vid anmälan ska anges, namn, person- eller organisationsnummer samt telefonnummer. I förekommande fall ska även antal biträden (högst två) anges. Efter registrerad anmälan kommer anmälaren att motta en bekräftelse. Om ingen bekräftelse erhålls har anmälan inte skett på rätt sätt.

Aktieägare som har sina aktier förvaltarregistrerade, d.v.s. förvarade i en depå, måste tillfälligt inregistrera aktierna i eget namn i den av Euroclear Sweden AB förda aktieboken för att få delta i stämman. Sådan registrering måste vara verkställd senast den 1 november 2019 och bör begäras i god tid före denna dag hos den som förvaltar aktierna.

Fullmakt Om aktieägare avser låta sig företrädas av ombud ska fullmakt utfärdas för ombudet. Fullmakten ska vara skriftlig, av aktieägaren undertecknad och daterad. Om aktieägaren är en juridisk person ska kopia av registreringsbevis eller, om sådan handling inte finns, motsvarande behörighetshandling bifogas anmälan. Handlingen ska styrka rätten hos den som undertecknat fullmakten att utse ombud för den juridiska personen. För att underlätta registreringen vid stämman bör fullmakt i original samt registreringsbevis och andra behörighetshandlingar vara bolaget till handa under ovanstående adress senast den 1 november 2019. Om fullmakt och övriga behörighetshandlingar inte insänts i förväg ska fullmakt i original samt övriga behörighetshandlingar kunna uppvisas vid stämman. Fullmaktsformulär finns tillgängligt hos bolaget och på bolagets hemsida, www.arocell.com, och sänds på begäran till aktieägare som uppger sin postadress.

Förslag till dagordning

Stämman öppnas
Val av ordförande vid stämman
Upprättande och godkännande av röstlängd
Godkännande av förslaget till dagordning
Val av en protokolljusterare
Prövning av om stämman blivit behörigen sammankallad
Beslut om godkännande av styrelsens beslut om företrädesemission
Beslut om godkännande av styrelsens beslut om riktad emission
Beslut om bemyndigande för VD att besluta om justering av besluten
Avslutning

Beslutsförslag

Beslut om godkännande av styrelsens beslut om företrädesemission (punkt 7) Styrelsen fattade den 22 oktober 2019 ett beslut om en företrädesemission som styrelsen nu föreslår att stämman godkänner. Beslutet har följande lydelse:

Bolagets aktiekapital ska öka med högst 2 628 496,30 kronor.
Antalet nyemitterade aktier ska uppgå till högst 26 284 963 stycken.
Innehav av en (1) befintlig aktie i Bolaget på avstämningsdagen den 15 november 2019 ska berättiga till två (2) teckningsrätter. Tre (3) teckningsrätter ska berättiga till teckning av en (1) ny aktie i Bolaget.
Teckningskursen för varje nyemitterad aktie ska vara 1,50 kronor.
Aktier som inte tecknas med företrädesrätt ska tilldelas dem som tecknat aktier utan stöd av teckningsrätt. Tilldelning utan företrädesrätt ska ske

i första hand till dem som även tecknat aktier med stöd av teckningsrätt (oavsett om dessa var aktieägare på avstämningsdagen eller ej), pro rata i förhållande till hur många aktier som tecknats med stöd av teckningsrätter, dock att tecknare som med tillämpning av denna tilldelningsprincip skulle ha tilldelats färre än 100 aktier efter lottning ska tilldelas antingen 100 aktier eller inga aktier,
i andra hand till andra som tecknat aktier utan företrädesrätt, pro rata i förhållande till hur många aktier som tecknats, dock att tecknare som med tillämpning av denna tilldelningsprincip skulle ha tilldelats färre än 100 aktier efter lottning ska tilldelas antingen 100 aktier eller inga aktier, och
i tredje hand till emissionsgaranter i enlighet med respektive garants garantiåtagande, dock att tecknare som med tillämpning av denna tilldelningsprincip skulle ha tilldelats färre än 100 aktier efter lottning ska tilldelas antingen 100 aktier eller inga aktier.

Teckningsperioden ska löpa från och med den 20 november 2019 till och med den4 december 2019.
Teckning med stöd av teckningsrätter ska ske genom betalning senast den4 december 2019. Teckning utan stöd av teckningsrätter ska ske på teckningslista varvid betalning ska erläggas senast tre bankdagar från avsändandet av besked om tilldelning.
Styrelsen ska ha rätt att förlänga teckningsperioden och tiden för betalning genom meddelande senast den sista dagen i teckningsperioden.
Nya aktier ska berättiga till utdelning den första avstämningsdagen för utdelning som infaller efter att de nya aktierna registrerats.
Bolagets VD bemyndigas att vidta de mindre justeringar i detta beslut som kan visa sig nödvändiga för registrering hos Bolagsverket och Euroclear Sweden AB.

Beslut om godkännande av styrelsens beslut om riktad emission (punkt 8) Styrelsen fattade den 22 oktober 2019 ett beslut om en riktad emission som styrelsen nu föreslår att stämman godkänner. Beslutet har följande lydelse:

Bolagets aktiekapital ska öka med högst 1 000 000 kronor.
Antalet nyemitterade aktier ska uppgå till högst 10 000 000 stycken.
För varje tecknad aktie ska erläggas 1,50 kronor. Teckningskursen har fastställts genom förhandlingar med ett antal investerare och bedöms vara marknadsmässig.
Rätt att teckna de nya aktierna ska, med avvikelse från aktieägarnas företrädesrätt, endast tillkomma ett begränsat antal utvalda nordiska kvalificerade investerare. Skälet till avvikelsen från aktieägarnas företrädesrätt är att tillföra Bolaget ytterligare kapital för att finansiera arbetet mot FDA-godkännande av AroCell TK 210 ELISA för marknaden i USA och även tillföra långsiktiga strategiska ägare samt därigenom främja Bolagets möjligheter att utveckla Bolaget för att skapa ytterligare värde för samtliga aktieägare.
Teckningsperioden ska löpa från och med den 20 november 2019 till och med den4 december 2019. Teckning ska ske genom betalning senast den 4 december 2019.
Styrelsen ska ha rätt att förlänga teckningsperioden och tiden för betalning genom meddelande senast den sista dagen i teckningsperioden.
Nya aktier ska berättiga till utdelning den första avstämningsdagen för utdelning som infaller efter att de nya aktierna registrerats.
Bolagets VD bemyndigas att vidta de mindre justeringar i detta beslut som kan visa sig nödvändiga för registrering hos Bolagsverket och Euroclear Sweden AB.

Beslut om bemyndigande för VD att besluta om justering av besluten (punkt 9) Styrelsen föreslår att stämman bemyndigar den verkställande direktören, eller den som den verkställande direktören i övrigt förordnar, att vidta smärre justeringar och förtydliganden av de på stämman fattade besluten i den utsträckning detta är erforderligt för registrering och verkställande av besluten.

Övrig information Beslut enligt punkt 8 är giltigt endast om det biträds av aktieägare med minst två tredjedelar av såväl de avgivna rösterna som de aktier som är företrädda vid stämman.

Fullständigt beslutsunderlag kommer att hållas tillgängliga hos bolaget och på bolagets hemsida minst två veckor före stämman. Handlingarna sänds, utan kostnad, på begäran till aktieägare som uppger sin postadress. Styrelsen och den verkställande direktören ska, om någon aktieägare begär det och styrelsen anser att det kan ske utan väsentlig skada för bolaget eller dotterbolaget, vid den extra bolagsstämman lämna upplysningar om förhållanden som kan inverka på bedömningen av ett ärende på dagordningen. Upplysningsplikten avser även bolagets förhållande till annat koncernföretag samt koncernredovisningen.

Behandling av personuppgifter
För information om hur dina personuppgifter behandlas se www.euroclear.com/dam/ESw/Legal/Integritetspolicy-bolagsstammor-svenska.pdf

Uppsala den 22 oktober 2019
AroCell AB (publ)
Styrelsen

Viktig information EJ AVSEDD FÖR DISTRIBUTION ELLER PUBLICERING, DIREKT ELLER INDIREKT, INOM ELLER TILL USA, AUSTRALIEN, HONGKONG, JAPAN, KANADA, SCHWEIZ, SINGAPORE, SYDAFRIKA ELLER NYA ZEELAND ELLER INOM ANNAN JURISDIKTION DÄR DISTRIBUTION ELLER PUBLICERING AV DETTA PRESSMEDDELANDE SKULLE VARA OLAGLIGT.

Detta meddelande utgör inte och är inte del av ett erbjudande om försäljning av säkerheter. Kopior av detta meddelande görs ej och får inte distribueras, publiceras eller skickas till USA, Australien, Hongkong, Japan, Kanada, Schweiz, Singapore, Sydafrika eller Nya Zeeland eller inom annan jurisdiktion där distribution av detta pressmeddelande skulle vara olagligt eller skulle kräva registrering eller andra åtgärder. Detta meddelande är för informationssyften endast och utgör inget prospekt eller annat erbjudande om försäljning eller inbjudan till ett erbjudande om köp av något värdepapper inom USA eller annan jurisdiktion. Värdepapper som kan komma att utges i samband med transaktionerna som det hänvisas till i detta meddelande kommer inte att registreras enligt ”U.S. Securities Act of 1933”, i dess ändrade lydelse (”Securities Act”), och kommer följaktligen inte att erbjudas eller säljas inom USA.

Detta meddelande utgör inte ett prospekt i enlighet med Europaparlamentets och rådets förordning (EU) 2017/1129 (”Prospektförordningen”). Ämnen som diskuteras i detta meddelande kan utgöra framåtblickande uttalanden. Framåtblickande uttalanden är uttalanden som inte är historiska fakta och som kan identifieras genom användande av ord som “tror”, “förväntas”, “förutser”, “ämnar”, “uppskattar”, “kommer”, “kan”, “fortsatt”, “bör” och liknande uttryck. Framåtblickande uttalanden i detta pressmeddelande baseras på olika antaganden, varav många i sin tur baseras på ytterligare antaganden. Trots att AroCell AB tror att dessa antaganden var rimliga när de gjordes, är dessa antaganden till sin natur föremål för väsentliga kända och okända risker, osäkerheter, oförutsedda händelser och andra viktiga faktorer som är svåra eller omöjliga att förutspå och som är bortom dess kontroll. Sådana risker, osäkerheter, oförutsedda händelser och andra viktiga faktorer kan komma att göra att faktiska händelser på ett betydande sätt skiljer sig från de förväntningar som uttrycks eller antyds i detta meddelande genom sådana framåtblickande uttalanden. Information, åsikter och framåtblickande uttalanden som framgår i detta meddelande avser endast dagen för dess avgivande, och kan komma att ändras utan notis om detta.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. For more information; www.arocell.com

The Board of Directors of AroCell AB (publ) ("AroCell“ or the “Company") has resolved, subject to approval by the Extraordinary General Meeting (“EGM”), on an issue of shares with preferential rights for existing shareholders (the "Rights Issue") of SEK 39.4m as well as a directed share issue of SEK 15m (the “Directed Issue”). The Rights Issue is covered by subscription commitments and guarantee commitments from principal owners and new investors corresponding to 100% of the issue proceeds. The Directed Issue is subscribed for by a limited number of qualified investors. Notice to shareholders of the EGM will be published trough a separate press release. AroCell also announces that the Company's interim report for the period January - September 2019 will be published on November 5, 2019 instead of November 15, 2019.

AroCell also announces that the Company’s interim report for the period January – September 2019 will be published on November 5, 2019 instead of November 15, 2019.

AroCell develops standardized modern blood tests to support the prognosis and follow up of cancer patients. The technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein concentrations in a blood sample. AroCell TK 210 ELISA format is simple and robust, requires no special instrumentation to perform and can easily be incorporated in to standard laboratory processes.

AroCell requires additional working capital to fund its continued growth and market expansion. Assuming full subscription of the Rights Issue and the Directed Issue the Company will receive SEK 54.4m before issue costs. The Company’s opinion is that the current offering will be sufficient to:

Obtain FDA approval of AroCell TK 210 ELISA for the US market and seek reimbursement (90% of proceeds)

If necessary, carry out additional clinical study/studies in the United States to support the FDA application
Study of health economics and pricing strategy
Market activities prior to product launch
Working capital to run the business until 2021, this includes another resource for the clinical operations

Expansion to other cancer indications in addition to breast cancer (10% of proceeds)

Initiate new studies to demonstrate the clinical utility of using AroCell TK 210 ELISA for other indications and support approval for clinical use in these indications

Comment from AroCell’s CEO, Michael Brobjer

“To finance the work in the US market and gain momentum in sales, we are executing a significant capitalization of AroCell. The goal is FDA approval, which is crucial for establishing AroCell TK 210 ELISA in the United States. The clinical trials already conducted show the great potential of our product, which is the basis for market entry in the United States. The directed issue means that AroCell attains reputable investors, which is an important addition to our ownership structure and strengthens our position. At the same time, we welcome our faithful existing owners to continue to support us in our quest to improve cancer care by subscribing in the Rights Issue. With these words, I would like to thank both newcomers and existing shareholders for their faith in AroCell’s future opportunities. “– Michael Brobjer, CEO.

The Rights Issue in brief
The Board of Directors has also today, October 22, 2019, subject to subsequent approval by the EGM scheduled to be held on November 8, 2019, resolved to offer existing shareholders to subscribe for shares in AroCell at a subscription price of SEK 1.50 through a Rights Issue. The Rights Issue comprises up to 26,284,936 shares, fully subscribed equivalent to an increase of the share capital of SEK 2,628,496.30. The total issue amounts to SEK 39,427,445.

The Rights Issue will be issued on the following terms:
The preemptive right to subscribe for new shares shall be in relation to the number of old shares that the shareholder owns, per each (1) existing share the shareholder receives two (2) subscription rights. Three (3) subscription rights are required to subscribe for one (1) new share. Those who are not current shareholders can also subscribe for shares in the Rights Issue. For shares subscribed for without preferential right, allotment shall take place as follows:

primarily to those who also subscribed for shares under subscription rights (whether they were shareholders on the record date or not), pro rata to the number of shares subscribed for under subscription rights, however, to subscribers who, with application of this the allotment principle would have been allotted fewer than 100 shares after the draw would be allotted either 100 shares or no shares;
in the alternative to others who subscribe for shares without preferential rights, pro rata in relation to how many shares have been subscribed, however, that subscribers who, having applied this allocation principle, would have been allocated fewer than 100 shares after drawing lots shall be allocated either 100 shares or no shares, and
thirdly, to issue guarantors in accordance with the respective guarantor’s guarantee undertaking, however, subscribers who, having applied this allocation principle, would have been granted fewer than 100 shares after drawing lots shall be allocated either 100 shares or no shares

Per each subscribed share, SEK 1.50 shall be paid. The record date, i.e. the day when shareholders must be entered into the share registry to receive preemptive right in the Rights Issue is November 15, 2019. The subscription period for new shares is from November 20 up to December 4 , 2019. Subscription for shares with preemptive right are made by cash payment. Subscription without preemptive right is made through a depository bank or directly to the issuer agent Aqurat Fondkommission on a special subscription list. Payment for shares subscribed for without preemptive right shall be made no later than three (3) business days after the decision on allocation, according to the instructions on the contract note. The Board of Directors is authorized to extend the subscription period and the time of payment. New shares are entitled to dividends for the first time on the dividend record date immediately following the registration of new shares with the Swedish Companies Registration Office (Sw. “Bolagsverket”). The Board of Directors, or an entity or person selected by the Board of Directors, reserves the right to make minor adjustments necessary for the registration at the Swedish Companies Registration Office and Euroclear Sweden AB. Fully subscribed, the issues will increase the share capital by SEK 2,628,496.30 to SEK 6,571,240.30 and the number of shares will increase by 26,284,936 shares to 65,712,408 shares. The dilution effect for shareholders not participating in the Rights Issue will be approximately 40 percent.

Subscription and guarantee commitments
AroCell has received subscription undertakings of approximately SEK 1.5m, representing approximately 4 percent of the Rights Issue and guarantee commitments of approximately SEK 37.9m, which together corresponds to 100 percent of the Rights Issue. The guarantee consists of a so called bottom guarantee which covers approximately 76 percent of the Rights Issue and a so called top guarantee covering the remaining 20 percent. Thus, the issue is fully covered by subscription commitments and guarantee commitments.

Preliminary timeline

November 5, 2019 – Publication of the Company’s interim report for the third quarter of 2019
November 8, 2019 – Extraordinary General Meeting
November 13, 2019 – Last day of trading incl. preferential rights
November 14, 2019 – First day of trading excl. preferential rights
November 15, 2019 – Record date
November 20, – December 2, 2019 – Trading in rights
November 20 – December 4, 2019 – Subscription period
November 20, 2019 – Until the Rights Issue is registered at the Swedish Companies Registration Office – Trading in BTA
December 9, 2019 – Disclosure of outcome of Rights Issue

Investor meetings
Invitation to investor meetings will be sent out separately and will also be presented on AroCell and Redeye AB’s respective websites (www.arocell.com, www.redeye.se)

Prospectus
Publication of the prospectus is expected around November 15, 2019. Full terms and conditions as well as information about subscription and guarantee commitments will be available in AroCell’s prospectus which, will be published on the Company’s and Redeye AB’s respective websites (www.arocell.com, www.redeye.se)

The Directed Issue in brief
The Board of Directors has today, October 22, 2019, subject to subsequent approval by the EGM scheduled to be held on November 8, 2019, resolved to carry out a Directed Issue of 10,000,000 shares at a subscription price of SEK 1.50 per share, increasing the share capital with SEK 1,000,000. The Company will receive SEK 15m through the Directed Issue. The dilution effect for current shareholders, calculated after the Rights Issue, will be approximately 13 percent.
The reason for the Directed Issue, deviating from the shareholders’ preferential rights, is to give the Board of Directors the required flexibility to finance and enable the continued rapid expansion on the U.S. market as well as secure additional working capital.
Advisers

Redeye Aktiebolag acts as financial adviser and Fredersen Advokatbyrå acts as legal adviser in connection with the issues.

Important information
The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in AroCell in any jurisdiction, neither from AroCell nor from someone else.
Any investment decision in connection with the Rights Issue must be made on the basis of all publicly available information relating to the Company. Such information has not been independently verified by the financial advisors. The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness.
This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into Australia, Hong Kong, Japan, Canada, New Zeeland, Singapore, South Africa, the United States or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations.
This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. A prospectus in Swedish regarding the Rights Issue described in this press release will be prepared and submitted to Swedish Financial Supervisory Authority (Sw. Finansinspektionen). Following the Swedish Financial Supervisory Authority’s approval and registration of the prospectus, the prospectus will be published and kept available at AroCell’s website.

Forward-looking statements
This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. For more information; www.arocell.com

Today AroCell announces 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 prostate cancer. The aim of the study is to determine the prognostic value of TK1 in newly diagnosed subjects with prostate cancer.

In the study TK1 protein levels will be assayed in serum samples collected from subjects with newly diagnosed prostate cancer and compared with the extent and speed of disease progression.

There is an acknowledged need for better prognostic tools in prostate cancer as in many men, the disease will take a benign course. There is a need to avoid over-treatment of these subjects while obtaining more accurate monitoring of those with active disease. This is particularly important with the advent of new and more effective therapies for prostate cancer.

The study will be 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.

“We are excited to work together with Tampere University Hospital, one of the World’s leading centers for prostate cancer research” says Michael Brobjer, CEO of AroCell. “The AroCell TK 210 ELISA kit is a cost-efficient way to improve the monitoring of subjects with prostate cancer via a simple blood test, reducing costs and morbidity and improving patient welfare.”

For more information:

Michael Brobjer, CEO

Telephone: +46(0)18 50 30 20

E-mail: michael.brobjer@arocell.com

About Thymidine Kinase 1

Thymidine Kinase 1 (TK1) is a key enzyme in DNA precursor synthesis. It is upregulated during the late G1 phase and early S phase of the cell cycle and its presence in cells is an indicator of active cell proliferation. Increased levels of TK1 in the blood can indicate active cell proliferation as a consequence of abnormal cell turnover and cell disruption triggered by for example therapeutic agents.

About TK 210 ELISA

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 in to 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 and relapse in subjects with hematological and solid tumors.

About Tampere University Hospital

Tampere University Hospital (TAYS), Tampere, Finland, is a world leader in research into prostate cancer. Its mission is to leverage basic sciences, epidemiology, computational biology, and clinical practice to find answers enabling better management of prostate cancer.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell’s new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. For more information; www.arocell.com

Patients treated with Epirubicin and Docetaxel before surgery were followed by their thymidine kinase (TK1) levels in blood to directly observe treatment response. The results show that a TK1-based cell-loss metric after two cycles of therapy predicted the status at the operation after six cycles of chemotherapy. The metric predicted early on whether or not the chemotherapy works.

The purpose with this PROMIX study is to investigate whether a cell-loss metric, defined as the ratio between serum concentration of thymidine kinase1 (sTK1) and the tumor volume, can be used in the early prediction of pathologic response.

The study was performed by collection serum from 104 patients with newly detected localized breast cancer during a neoadjuvant Phase II trial. Blood was collected before each cycle of chemotherapy and 48 hours after each cycle, which eliminate the biological variations seen in the proteome between different patients. The concentration of TK1 in blood was measured with TK 210 ELISA.

The result showed that the cell-loss metrics, combining sTK1 and tumor volume, was significantly associated with the presence or absence of the tumor in the surgical specimen after six cycles of chemotherapy.

“We are excited, this study tells us that TK 1 can be of great value in modern precision medicine. The results also support AroCell’s focus on monitoring breast cancer treatment.” says professor Claes Post, Chairman of the Board of AroCell.

“We are pleased that the team at Karolinska has performed this study with such exciting results. Early detection of therapy response is crucial in selecting correct treatment to each individual patient ” says Michael Brobjer, CEO “The implication of this can well be to prevent patients to undergo chemotherapy treatment that they don’t respond to”.

The study concludes that TK1 has the potential to be of great value for early prediction on response of cytostatic treatment for patients with breast cancer.

Link to the complete article.

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, September 18, 2019 at 17:10.

About Thymidine Kinase 1
Thymidine Kinase 1 (TK1) is a key enzyme in DNA precursor synthesis. It is upregulated during the late G1 phase and early S phase of the cell cycle and its presence in cells is an indicator of active cell proliferation. Increased levels of TK1 in the blood can indicate active cell proliferation as a consequence of abnormal cell turnover and cell disruption triggered by for example therapeutic agents.

About TK 210 ELISA
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 in to 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 and relapse in subjects with hematological and solid tumors.

About Promix
PROMIX – Preoperative treatment of breast cancer with a combination of epirubicin, docetaxel and bevacizumab. A translational trial on molecular markers and functional imaging to predict early response. The study was performed at Department of Oncology-Pathology, Karolinska Institute and University Hospital Solna, Stockholm, Sweden. The trial registration can be found here: Clinical Trials.gov Identifier:NCT000957125 (Link).

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

PM Promix article ENG 2019-09-18

AroCell AB (publ.) announces today that Peter Löwendahl joins the management team as senior director regulatory affairs. Peter Löwendahl will lead and develop AroCell’s regulatory strategy with focus on the US market and FDA clearance of our TK 210 ELISA.

Peter Löwendahl has almost 30 years of experience in quality and regulatory affairs and has previously been responsible for Quality and Regulatory affairs at Elekta AB and global regulatory responsibility for GE Healthcare's Life science division. In the last 3 years, he works mainly as a senior consultant and advisor for Hoff & Lowendahl AB.

“I’m very glad that we attracted Peter as responsible for AroCell’s regulatory strategy. AroCell is in an exciting phase entering into the US market and the regulatory path is an important part of this”, says Michael Brobjer, CEO at AroCell. “Peter’s long experience of setting medical devices on the US market gives me confidence that he will add knowledge and experience into the company.”

”I look forward working with AroCell and their biomarker assay. I’m impressed of what a small team can accomplish and eager to be a part of it”, says Peter Löwendahl.

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

This information was submitted for publication through the agency of Michael Brobjer, September 11, 2019 at 14:00.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure 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

Attachment

PM ENG 2019- Regulatory Affairs

Word from the CEO

“It is with pleasure that I can say that the second quarter of 2019 became one of the most exciting and active quarters in AroCell's history. The goal of establishing AroCell as the given partner and supplier of a reliable method for measuring Thymidine kinase 1 in the blood permeates everything we do. During the quarter, we increased sales, signed more distributor agreements, signed a collaboration agreement with CLIA lab in the US and started a collaboration with the Dana Farber Cancer Institute in the USA.

Our belief is that thymidine kinase is a superior biomarker for early detection of treatment result during cancer treatment. By measuring TK1 levels in the bloodstream, treatment can be improved and thereby increase the survival and quality of life for patients and reduce the costs for caregivers."

Michael Brobjer, CEO

Reporting period 1 April – 30 June 2019

Net sales were 127 (621) KSEK
Loss before financial items was -4 915 (-5 712) KSEK
Cash flow from operating activities was -4 060 (-3 897) KSEK
Earnings per share before and after dilution were -0,12 (-0,17) SEK
Cash and cash equivalents were at the end of the period 21 435 (39 207) KSEK

Reporting period 1 January – 30 June 2019

Net sales were 203 (621)KSEK
Loss before financial items was -10 202 (-9 894) KSEK
Cash flow from operating activities was -8 462 (-7 009) KSEK
Earnings per share before and after dilution were -0,26 (-0,32) SEK
Cash and cash equivalents were at the end of the period 21 435 (39 207) KSEK

Significant events during the reporting period 1 April – 30 June

AroCell initiated a collaboration with Corgenix Inc. which can offer analysis of Thymidine kinase 1 using AroCell TK 210 ELISA in the USA. AroCell TK 210 ELISA kit has been validated and approved for Thymidine Kinase 1 (TK1) measurements in human samples at Corgenix laboratory facility in Colorado, USA.
A distribution agreement was signed with Mumbai-based company Inveniolife Technology Pvt. Ltd. for distribution of AroCell TK 210 ™ ELISA in India.
AroCell established a scientific council to support the company in its expansion over the next few years.

Significant events after the reporting period

AroCell initiated a collaboration with the Dana Farber Cancer Institute to evaluate AroCell TK 210 ELISA on patients treated with CDK4 / 6 inhibitors. The purpose of this study is to investigate the compliance of serum TK1 concentration and clinical response to treatment.
AroCell AB signed a distribution agreement with Diapharma Group in West Chester, Ohio for the marketing and distribution of AroCell TK 210 ™ ELISA in the US and Canada.
Redeye initiated analyst coverage and has published an analysis report of Arocell.

Interim report April 1st to June 30, 2019 (available in Swedish only) (PDF)

For more information:

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, August 21, 2019 at 08:00.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se,
+46 (0)8 121 576 90. For more information; www.arocell.com

.

6

Attachment

PM Q2 2019 EN

AroCell AB (publ) announced today that it has signed a distribution agreement with Diapharma Group of West Chester Ohio for the promotion and distribution of the AroCell TK 210™ ELISA in the United States and Canada.

Diapharma sells tests and instrumentation for the diagnostic and research fields and provides strong technical competence and experience to ensure that their customer expectations are met.

“We look forward to this new collaboration with Diapharma Group for the distribution and promotion of AroCell TK 210 ELISA in US and Canada”, says Michael Brobjer, AroCell’s CEO. “With the agreement we expect an increase in promotion and sales efforts on our major markets. Diapharma has proven to be a very competent and active distributor with sales reps with high expertise in the area of diagnostics and analytical biochemistry.”

This agreement supports AroCell´s commercialization strategy to expand sales of the AroCell TK 210 ELISA in the USA and Canada. The agreement with Diapharma complement the already existing distribution agreement with Eagle Bioscience. The aim is to increase and to facilitate sales and application in clinical researches and drug development in oncology.

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, August 6, 2019 at 08:15.

About Thymidine Kinase 1
Thymidine Kinase 1 (TK1) is a key enzyme in DNA precursor synthesis. It is upregulated during the late G1 phase and early S phase of the cell cycle and its presence in cells is an indicator of active cell proliferation. Increased levels of TK1 in the blood can indicate active cell proliferation as a consequence of abnormal cell turnover and cell disruption triggered by for example therapeutic agents.

About TK 210 ELISA
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 in to 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 and relapse in subjects with hematological and solid tumors.

About Diapharma
DiaPharma Group, Inc. is a distributor of test kits, bioreagents, chromogenic substrates, antibodies and instruments in many different fields including, Apoptosis, Immunology, and Oncology. DiaPharma’s clinical test kits are used in hospital laboratories, clinical reference laboratories and universities. Their line of research products is marketed to researchers and medical corporations for use in product development and in quality control laboratories.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

PM ENG 2019- 2019-08-06

Today AroCell announces a collaboration with Dana Faber Cancer Institute to evaluate AroCell’s TK 210 ELISA assay on CDK4/6 inhibitor treated patients. The aim of the study is to examine concordance of TK 1 concentration in serum and clinical response on treatment.

In the study samples will be collected from patients treated with CDK 4/6 inhibitor palbociclib throughout the course of the treatment and the concordance between AroCell’s TK 210 ELISA assay and clinical response will be evaluated. The study will include about 20 patients.

The study will be executed in collaboration with Dana Farber Cancer Institute and coordinated by Dr. Geoffrey Shapiro, Director of Early Drug Development Center at Dana Farber Cancer Institute.

AroCell TK 210 ELISA is a robust, reproducible and cost-effective assay that measure the TK1 (Thymidine Kinase 1) levels in serum. The objective is to help clinicians obtain more information by measuring the outcome of the treatment as well as to provide decision support in disease management.

“We are excited to work together with Dana Faber Cancer Institute to evaluate TK1 as a biomarker for treatment response in cancer therapy using Pfizers CDK 4/6 inhibitor palbociclib“ says Michael Brobjer, CEO of AroCell. “Our TK 210 ELISA kit is a costefficient way to measure TK1 by a simple blood test”

A recent addition to the therapeutic arsenal is Cycline-Dependent Kinase (CDK) inhibitors. These drugs work by inhibiting CDK 4 or/and CDK 6. Overactivity of kinases facilitates the proliferation of cancer cells. The CDK 4/6 inhibitors cause cell cycle arrest and prevent cells from proliferating

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, August 01, 2019 at 17:15.

About Thymidine Kinase 1
Thymidine Kinase 1 (TK1) is a key enzyme in DNA precursor synthesis. It is upregulated during the late G1 phase and early S phase of the cell cycle and its presence in cells is an indicator of active cell proliferation. Increased levels of TK1 in the blood can indicate active cell proliferation as a consequence of abnormal cell turnover and cell disruption triggered by for example therapeutic agents.

About Dana Farber
Dana Farber Cancer Institute in Boston, MA, is a world leader in adult and pediatric cancer treatment and research. Since its founding in 1947, Dana-Farber Cancer Institute has been committed to providing adults and children with cancer with the best treatment available today while developing tomorrow's cures through cutting-edge research.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

PM ENG 2019-08-01

We initiate coverage of AroCell, a diagnostics company that focuses on the research, development and sales of an in vitro diagnostics product for cancer, called TK 210 ELISA, and the licensing of the technology behind this. After several years focusing on research and development, AroCell is now switching over to a commercial focus with itsTK 1 technology for cancer therapy response analysis. We see several potential catalysts in the short- and mid-term that are positive for the stock.

Read more and download the research update: http://bit.ly/2Jevv6g

Start following companies at Redeye to receive the latest equity research within Life Science and Technology.

This is a press release from Redeye - Research Powered Investment Banking. https://www.redeye.se/about/

(Available inSwedish only)

AroCell AB (publ) (”Bolaget”) höll idag den 16 maj 2019 i Uppsala sin årsstämma för verksamhetsåret 2018, varvid följande beslut fattades.

För mer detaljerad information om innehållet i besluten hänvisas till den fullständiga kallelsen till årsstämman. Kallelse till årsstämma samt fullständiga förslag finns tillgängliga på Bolagets webbplats, www.arocell.com

Fastställande av resultat- och balansräkning
Årsstämman fastställde resultaträkningen för 2018 och balansräkningen per den 31 december 2018.

Resultatdisposition
I enlighet med styrelsens förslag beslutade årsstämman att disponera vinstmedlen så att ansamlad förlust om 87 340 770 kronor samt överkursfond om 130 431 828 kronor balanseras i ny räkning.

Ansvarsfrihet
Årsstämman beviljade styrelsens ledamöter och verkställande direktören ansvarsfrihet för räkenskapsåret 2018. Beslutet omfattade även tidigare under året verksamma verkställande direktörer Jan Stålemark och Johan von Heijne avseende deras respektive förvaltning.

Arvode till styrelse och revisor
I enlighet med valberedningens förslag beslutade årsstämman att arvodet till styrelseordförande ska uppgå till 250 000 kronor och 150 000 kronor vardera till övriga ledamöter. Arvode till revisor ska utgå enligt godkänd räkning.

Val av styrelse och revisor
I enlighet med valberedningens förslag beslutade årsstämman att styrelsen ska bestå av fem styrelseledamöter och inga suppleanter. Årsstämman omvalde Staffan Eriksson, Agneta Franksson, Claes Post samt Gunnar Steineck samt nyval av Karin Eriksson-Vidblom. Stämman omvalde Claes Post till ordförande.

I enlighet med valberedningens förslag omvaldes det registrerade revisionsbolaget Öhrlings PricewaterhouseCoopers AB (PwC) till Bolagets revisor, med Leonard Daun som huvudansvarig revisor.

Valberedning
Årsstämman beslutade, i enlighet med valberedningens förslag, att Bolaget ska ha en valberedning enligt principer som är oförändrade från föregående år. De tre största aktieägarna äger rätt att utse varsin valberedningsledamot. Därutöver skall styrelsens ordförande ingå i valberedningen.

Ändring av bolagsordning
I enlighet med styrelsens förslag beslutade årsstämman att ändra paragraferna 4 och 5 i bolagsordningen så att de lyder:
§ 4 Aktiekapitalet ska uppgå till lägst 3 000 000 kronor och högst 12 000 000 kronor
§ 5 Antalet aktier ska uppgå till lägst 30 000 000 och högst 120 000 000.

Emission av teckningsoptioner till anställda
I enlighet med styrelsens förslag beslutade årsstämman om emission av högst 900 000 teckningsoptioner med avvikelse från aktieägarnas företrädesrätt. Rätt att teckna de nya teckningsoptionerna ska tillkomma anställda i Bolaget.

Teckning av aktier med stöd av teckningsoptionerna ska ske i enlighet med villkoren för teckningsoptionerna från och med den 16 maj 2020 till och med den 16 maj 2021. Om samtliga teckningsoptioner utnyttjas för teckning av aktier kommer Bolagets registrerade aktiekapital att öka med 90 000 kronor.

Emission av teckningsoptioner till styrelseledamöter
I enlighet med aktieägare Jon Eikens förslag beslutade årsstämman om emission av högst 500 000 teckningsoptioner med avvikelse från aktieägarnas företrädesrätt. Rätt att teckna de nya teckningsoptionerna ska tillkomma styrelseledamöter i Bolaget.

Teckning av aktier med stöd av teckningsoptionerna ska ske i enlighet med villkoren för teckningsoptionerna från och med den 16 maj 2020 till och med den 16 maj 2021. Om samtliga teckningsoptioner utnyttjas för teckning av aktier kommer Bolagets registrerade aktiekapital att öka med 50 000 kronor.

Bemyndigande för styrelsen att emittera aktier, konvertibler eller teckningsoptioner
I enlighet med styrelsens förslag beslutade årsstämman att bemyndiga styrelsen att, vid ett eller flera tillfällen före nästa årsstämma, med eller utan avvikelse från aktieägarnas företrädesrätt, besluta om nyemission av aktier eller emission av konvertibler eller teckningsoptioner. Emission ska kunna ske mot kontant betalning, apport eller kvittning eller i övrigt på marknadsmässiga villkor som styrelsen bestämmer. Antalet aktier, konvertibler eller teckningsoptioner som ska kunna ges ut med stöd av bemyndigande ska vara begränsat på så sätt att antalet aktier efter fulltecknad nyemission, fullt utnyttjande av teckningsoptioner eller full konvertering, inte ökar med mer än 10% av vid tidpunkten för kallelsen utestående aktier.

För ytterligare information:
Michael Brobjer, VD
Telefon: +46(0)18 50 30 20
E-post: michael.brobjer@arocell.com

Informationen ovan lämnades, genom Michael Brobjers försorg, för offentliggörande den 16 maj, 2019 kl. 14:30.

Kort om AroCell

AroCell AB är ett svenskt företag som utvecklar standardiserade moderna blodtest för att stödja behandling, prognos och uppföljning av cancerpatienter. AroCells teknik är baserad på patenterade metoder för att mäta proteinet Tymidinkinas 1 (TK1) i blodprov. TK 210 ELISA ger värdefull information som hjälper kliniker att optimera behandlingsstrategier och prognostisera risken för återkommande tumörsjukdom vid monitorering och uppföljning av patienten. AroCell (AROC) är listat på Nasdaq First North med Redeye AB som Certified Adviser. Certifiedadviser@redeye.se, +46 (0)8 121 576 90.För mer information, se www.arocell.com

Attachment

Kommuniké från Årstämma 2019 SE .docx

Word from the CEO

“Biomarkers will play an increasingly important role in how we identify and follow up treatments for patients with cancer in the coming years. The development of an increased individual adaptation of treatment is driven by the use of biomarkers which enable diagnosis of which tumor type the patient has and also what treatment the patient should receive.

Thymidine Kinase is an important and exciting biomarker that can provide early detection of therapy response in cancer treatment, which means increased survival and better quality of life for the patient and reduced costs for the healthcare provider."

Michael Brobjer, CEO

Significant events during the reporting period 1 October – 31 December

AroCell signed a distribution agreement with the Beijing based company Gongyingshi for the promotion and distribution of the AroCell TK 210™ ELISA in China. AroCell thereby has five distributors covering large parts of Europe, the US, China, and South Korea.
A new scientific publication from AroCell on TK 210 ELISA in prostate cancer was published the peer-reviewed journal “The Prostate” with the title: “The combination of AroCell TK 210 ELISA with Prostate Health Index or protease-specific antigen density can improve the ability to differentiate prostate cancer from noncancerous conditions”. The aim of the study was to investigate the diagnostic value of the AroCell TK 210 ELISA together with free PSA, pro PSA and PHI in differentiating prostate cancer from benign urological conditions. The results showed that the combination of TK1 with PSAD or TK1 with PHI has significantly higher sensitivity than those for the individual PSA-related biomarkers.
An abstract from AroCell vas accepted for poster presentation on the American Association of Cancer Research 2019 (AACR 2019) held from March 29 to April 3 in Atlanta, Georgia, USA. The Study compares AroCell TK210 ELISA with TK-Liaison assay.
The European Patent Office (EPO) granted Arocell a new patent (nr. 3083698) with the title ”Monoclonal Anti-TK1 Antibodies”. The patent is referring to AroCell’s proprietary technology of specific and sensitive immunological measurement of Thymidine Kinase 1 in serum. More specifically, the monoclonal antibody, XPA210-Ar1, is covered in the patent.
AroCell launched a new website. The goal with the new website is to facilitate for customers, business partners and investors to find relevant information about AroCell.

Significant events after the reporting period

AroCell initiated a collaboration with Corgenix (Corgenix Inc., Colorado USA) to establish the measurement of Thymidine Kinase 1 using AroCell TK 210 ELISA in a CLIA-lab. The AroCell TK 210 ELISA kit vas validated and approved for Thymidine Kinase 1 (TK1) measurements in human samples for preclinical and clinical use at the Corgenix laboratory facility in Colorado, USA.
AroCell established a Scientific Advisory Board to support the company in its planned expansion in the coming years.
AroCell AB signed a distribution agreement with the Mumbai based company Inveniolife Technology Pvt. Ltd. for the promotion and distribution of the AroCell TK 210™ ELISA in India.

Reporting period 1 January – 31 March 2019

Net sales were 76 (-) KSEK
Loss before financial items was -5 287 (-4 182) KSEK
Cash flow from operating activities was -4 402 (-3 112) KSEK
Earnings per share before and after dilution were -0,13 (-0,15) SEK
Cash and cash equivalents were at the end of the period 25 332 (14 137) KSEK

Interim report 1st January to 31st of March 2018 (available in Swedish only) (PDF)

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, May 16, 2019 at 08:00.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

.

Attachments

AroCell AB (publ) announce today that a distribution agreement has been signed with the Mumbai based company Inveniolife Technology Pvt. Ltd. for the promotion and distribution of the AroCell TK 210™ ELISA in India.

AroCell’s TK 210 ELISA measures concentration levels of thymidine kinase 1 (TK 1) in blood samples and provides valuable information about cell proliferation and disruption in patients with cancer tumors. TK 210 ELISA may also support clinicians to optimize treatment and estimate the risk of recurrence.

“We are looking forward to this new collaboration with Inveniolife for the distribution and promotion of AroCell TK 210 ELISA in India”, says Michael Brobjer, AroCell’s CEO. “This is in line with our strategy to reach all major markets with our product by collaboration with top line distributors. Inventiolife is a well established distributor for the drug discovery, pharma and clinical market in India and has a strong sales team covering academic institutions, CROs and drug discovery companies throughout India.”

This agreement supports AroCell´s commercialization strategy to make AroCell TK 210 ELISA widely available and to facilitate the use of the product in clinical research, routine clinical laboratories as well as for drug development within the pharmaceutical industry.

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, May 2, 2019 at 08:00.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

PM ENG 2019-05-02 Final

AroCell announces today that we have established a Scientific Advisory Board to support the company in its planned expansion for the coming years.

The Scientific Advisory Board (SAB) will have the objective to support the CEO and company in various matters related to AroCell’s expansion in the field of in vitro Diagnostics (IVD). The Scientific Advisory Board will focus on scientific, clinical and regulatory matters relating to AroCell’s expansion into the EU, USA and other new markets.

The first member of the SAB is Johan von Heijne, CEO of Pharm Assist Sweden AB. Johan has long experience from various roles as CEO in companies working in the field of IVD and medical devices. His expertise in regulatory matters which he has built up over the years will be valuable for AroCell. The fact that he has a genuine and deep knowledge of AroCell as being board member since 2017 and acting CEO during part of 2018 will add further value to AroCell.

“I am very pleased that a SAB is in place at AroCell and I welcome Johan as its first member. We expect that the SAB will grow further and contribute to the company over the coming years” says Michael Brobjer, CEO of AroCell.

“AroCell’s technology and ambitious growth plan is solid and I’m eager to continue to contribute as part of the newly formed SAB” says Johan von Heijne, CEO of Pharm Assist Sweden AB.

The aim of the SAB will be to contribute in evaluating possible clinical trials to be initiated and conducted by AroCell, regulatory expertise as well as market introduction knowledge. The SAB will constitute of 3-4 members and meet regularly as needed. Additional members will be introduced during 2019.

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

information was submitted for publication through the agency of Michael Brobjer, April 17, 2019, at 08:00.

About Pharm Assist Sweden AB

Pharm Assist is a professional consultancy service company offering quality and regulatory solutions for medicinal products and medical devices. Founded in 1996, the company has assisted more than 200 pharmaceutical and medical device companies over the years.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

Advisory Board PM ENG 2019-04-17

Available in Swedish only

Aktieägarna i AroCell AB (publ), org.nr 556596–6107 (”Bolaget”) kallas härmed till årsstämma torsdagen den 16 maj 2019, kl. 13 i lokalen Karin Boye på Virdings allé 32 B i Uppsala. Registreringen börjar kl. 12.30 och avbryts när stämman öppnas.

Anmälan m.m.

Aktieägare som önskar delta i årsstämman ska:

dels upptagits som aktieägare i eget namn i den av Euroclear Sweden AB förda aktieboken avseende förhållandena fredagen den 10 maj 2019 (avstämningsdagen), och
dels anmäla sitt deltagande så att denna är Bolaget tillhanda senast kl. 16:00 fredagen den 10 maj 2019, under adress AroCell AB (publ), Virdings allé 32B, 754 50 Uppsala alternativt e-mail till bolagsstamma2019@arocell.com.

Vid anmälan ska anges aktieägarens namn, person- eller organisationsnummer, adress, telefonnummer (dagtid) samt i förekommande fall uppgift om eventuella biträden (högst två).

Förvaltarregistrerade aktier

Aktieägare som har sina aktier förvaltarregistrerade (dvs. förvarade i depå) måste, för att äga rätt att delta i årsstämman, tillfälligt inregistrera aktierna i eget namn i den av Euroclear Sweden AB förda aktieboken. Sådan omregistrering måste vara verkställd på avstämningsdagen den 10 maj 2019. Detta innebär att aktieägare i god tid före denna dag måste meddela sin begäran härom till förvaltaren.

Ombud

Aktieägare som avser att närvara genom ombud ska utfärda fullmakt för ombud. Fullmakten ska vara skriftlig, undertecknad av aktieägaren och daterad. Om fullmakt utfärdas av juridisk person ska bestyrkt kopia av registreringsbevis eller motsvarande för den juridiska personen bifogas. Handlingen ska styrka rätten hos den som undertecknat fullmakten att utse ombud för den juridiska personen. Fullmakts giltighet får anges till längst fem år från utfärdandet. För att underlätta registreringen vid stämman bör fullmakt i original samt eventuellt registreringsbevis och andra behörighetshandlingar vara Bolaget tillhanda under ovanstående adress senast kl. 16.00 den 10 maj 2019. Om fullmakt och övriga behörighetshandlingar inte insänts i förväg ska fullmakt i original samt övriga behörighetshandlingar kunna uppvisas vid stämman. Bolaget tillhandahåller fullmaktsformulär på begäran och detta finns också tillgängligt på Bolagets hemsida, www.arocell.com.

Antal aktier och röster

I Bolaget finns vid tidpunkten för utfärdandet av denna kallelse totalt 39 427 445 aktier med en röst vardera.

Förslag till dagordning

Öppnande och val av ordförande vid stämman
Upprättande och godkännande av röstlängd
Val av en eller två justeringspersoner
Prövning av om stämman blivit behörigen sammankallad
Godkännande av dagordning
VD-presentation
Framläggande av årsredovisning och revisionsberättelse
Beslut angående
1. Fastställande av resultaträkningen och balansräkningen
2. Dispositioner beträffande Bolagets resultat enligt den fastställda balansräkningen
3. Ansvarsfrihet åt styrelseledamöterna och den verkställande direktören
Beslut om antal styrelseledamöter
Fastställande av arvode till styrelsen och revisorerna
Val av
1. Styrelseledamöter och styrelseordförande
2. Revisorer
Beslut om valberedning inför nästa årsstämma
Beslut om ändring av bolagsordning
Styrelsens förslag till beslut om emission av teckningsoptioner till anställda i Bolaget
Jon Eikens förslag till beslut om emission av teckningsoptioner till styrelsen
Beslut om bemyndigande för styrelsen att emittera aktier, konvertibler eller tecknings-optioner
Stämmans avslutande

Huvudsakliga förslag till beslut, (se även punkten Tillhandahållande av handlingar)

Punkt 1 – Val av ordförande av stämman

Valberedningen föreslår att jur.kand. Torbjörn Koivisto ska vara ordförande vid stämman.

Punkt 8b – Beslut om dispositioner beträffande Bolagets resultat enligt den fastställda balansräkningen

Styrelsen föreslår att bolagsstämman beslutar att ansamlad förlust om 87 340 770 kronor samt överkursfond om 130 431 828 kronor balanseras i ny räkning.

Punkt 9 – Beslut om antal styrelseledamöter
Valberedningen föreslår att antalet styrelseledamöter ska uppgå till fem och inga suppleanter.

Punkt 10 – Fastställande av arvoden till styrelsen och revisorerna
Valberedningen föreslår att styrelsearvode ska utgå med 250 000 kronor till styrelseordförande och med 150 000 kronor vardera till övriga styrelseledamöter.
Valberedningen föreslår vidare att arvode till revisorn ska utgå enligt godkänd räkning.

Punkt 11 – Val av styrelseledamöter och revisorer

Valberedningen föreslår omval av Staffan Eriksson, Agneta Franksson, Claes Post och Gunnar Steineck, samt nyval av Karin Eriksson-Widlund, som ordinarie ledamöter för tiden till nästa årsstämma. Valberedningen föreslår Claes Post som ordförande.
Valberedningen föreslår att årsstämman för tiden intill utgången av nästa årsstämma omväljer det registrerade revisionsbolaget PwC till Bolagets revisor, med auktoriserade revisorn Leonard Daun som huvudansvarig revisor.

Punkt 12 Beslut om valberedning inför nästa årsstämma

Valberedningens föreslår följande principer för valberedningen.
Valberedningen skall bestå av fyra ledamöter. De tre största aktieägarna som är registrerade hos Euroclear Sweden AB den sista september året innan stämman äger rätt att utse varsin valberedningsledamot. Därutöver skall styrelsens ordförande ingå i valberedningen. Styrelsens ordförande kallar till första möte. Styrelsens ordförande skall inte vara valberedningens ordförande. Styrelsens ordförande skall inte ha rösträtt i valberedningen. Vid kända väsentliga ägarförändringar som äger rum tidigare än åtta veckor före årsstämman skall ändring av valberedningens sammansättning ske i enlighet med principer angivna ovan. Arvode till valberedningens ledamöter skall inte utgå. Ersättning utgår dock för skäliga utgifter i samband med uppdraget. Senast 6 veckor före årsstämman skall valberedningen lämna förslag avseende: ordförande för stämman, ordförande och övriga styrelseledamöter, arvode till ordförande och övriga styrelseledamöter, i förekommande fall val av revisor och arvode till revisor samt i förekommande fall ändringar i denna instruktion och arbetsordning för valberedningen.

Punkt 13 – Beslut om ändring av bolagsordning

Styrelsen föreslår att bolagsordningens § 4 och § 5 ändras så att;

      ·Aktiekapitalet ska vara lägst 3 000 000 kronor och högst 12 000 000 kronor
      ·Antalet aktier ska vara lägst 30 000 000 och högst 120 000 000.

Punkt 14 – Styrelsens förslag till beslut om emission av teckningsoptioner till anställda i Bolaget
Styrelsen föreslår att bolagsstämman beslutar om emission av högst 900 000 teckningsoptioner med avvikelse från aktieägarnas företrädesrätt. Styrelsen föreslår att bolagsstämman beslutar om nyemission enligt villkoren nedan.

Rätt att teckna nya teckningsoptioner ska, med avvikelse från aktieägarnas företrädesrätt, tillkomma 4 anställda i Bolaget.
Skälet till avvikelsen från aktieägarnas företrädesrätt är att bolaget bedömer det vara till fördel för Bolaget och dess aktieägare att Bolagets medarbetare görs delaktiga i bolagets utveckling genom att erbjudas förvärva teckningsoptioner. Ett personligt långsiktigt ägarengagemang kan förväntas stimulera till ett ökat intresse för verksamheten och resultatutvecklingen.
Teckning av teckningsoptionerna ska ske genom teckning på teckningslista senast den 24 maj 2019. Styrelsen ska äga rätt att förlänga teckningstiden.
För varje teckningsoption som tecknas ska den teckningsberättigade betala ett pris som fastställs av Bolaget, eller ett av Bolaget anlitat oberoende värderingsinstitut eller revisionsbolag, när genomsnittskursen enligt punkt 6 nedan fastställts, och som motsvarar teckningsoptionens marknadsvärde beräknat enligt Black & Scholes värderingsmodell. Betalning för tecknade teckningsoptioner ska i sin helhet erläggas kontant senast den 31 maj 2019. Styrelsen ska äga rätt att förlänga betalningstiden.
Om samtliga teckningsoptioner utnyttjas för teckning av aktier kommer Bolagets registrerade aktiekapital att öka med 90 000 kronor.
Varje teckningsoption ska medföra en rätt att teckna en ny aktie i bolaget till en teckningskurs motsvarande 200 procent av den volymvägda genomsnittskursen för bolagets aktie under den närmaste perioden om tio handelsdagar omedelbart före bolagsstämmans beslut om emission av teckningsoptionerna, dock som lägst aktiens kvotvärde. Den sålunda framräknade teckningskursen ska avrundas till närmaste tiondels öre varvid 0,05 öre ska avrundas nedåt.
Teckning av aktier med stöd av teckningsoptionerna ska ske i enlighet med villkoren för teckningsoptionerna från och med den 16 maj 2020 till och med den 16 maj 2021.
Aktie som tillkommit på grund av nyteckning medför rätt till vinstutdelning första gången på den avstämningsdag för utdelning som infaller närmast efter det att nyteckningen har registrerats hos Bolagsverket och aktierna införts i aktieboken hos Euroclear Sweden AB.
För teckningsoptionerna ska i övrigt gälla de villkor som framgår av dokumentet ”Villkor för teckningsoptioner 2019/2021 nr I”.
Styrelsens ordförande, eller den styrelsen utser, ska äga rätt att vidta de smärre justeringar som kan bli erforderliga i samband med registrering av beslutet hos Bolagsverket och Euroclear Sweden AB.

En förutsättning för att deltagarna skall erbjudas att teckna teckningsoptioner är att dessa personer dessförinnan ingått ett s.k. hembudsavtal enligt vilket deltagarna ska vara förpliktade att erbjuda Bolaget att förvärva teckningsoptionerna, eller viss del av dessa, om teckningsoptionerna ska överlåtas till tredje man.
Vid fullt utnyttjande av teckningsoptionerna kommer aktiekapitalet att öka med 90 000 kronor. Det innebär att vid fullt utnyttjande av föreslagna teckningsoptioner kommer utspädningseffekten av de nya aktierna att motsvara cirka 2,2 procent av såväl aktierna som röstetalet i bolaget. Utspädningseffekten avseende aktierna och rösterna i bolaget i anledning av nytecknade aktier med stöd av teckningsoptionerna har beräknats genom att det totala antalet aktier som teckningsoptionerna berättigar till nyteckning av har dividerats med det totala antalet aktier efter det att teckningsoptionerna har utnyttjats för nyteckning av aktier.

Punkt 15 – Jon Eikens förslag till beslut om emission av teckningsoptioner till styrelsen

Aktieägare Jon Eiken, representerande 3,3 % av det totala antalet aktier och röster per dagen för denna kallelse, föreslår att bolagsstämman beslutar om emission av högst 500 000 teckningsoptioner med avvikelse från aktieägarnas företrädesrätt på följande villkor:

Rätt att teckna nya teckningsoptioner ska, med avvikelse från aktieägarnas företrädesrätt, tillkomma 5 styrelsemedlemmar i Bolaget.
Skälet till avvikelsen från aktieägarnas företrädesrätt är att bolaget bedömer det vara till fördel för Bolaget och dess aktieägare att Bolagets styrelsemedlemmar görs delaktiga i bolagets utveckling genom att erbjudas förvärva teckningsoptioner. Ett personligt långsiktigt ägarengagemang kan förväntas stimulera till ett ökat intresse för verksamheten och resultatutvecklingen.
Teckning av teckningsoptionerna ska ske genom teckning på teckningslista senast den 24 maj 2019. Styrelsen ska äga rätt att förlänga teckningstiden.
För varje teckningsoption som tecknas ska den teckningsberättigade betala ett pris som fastställs av Bolaget, eller ett av Bolaget anlitat oberoende värderingsinstitut eller revisionsbolag, när genomsnittskursen enligt punkt 6 nedan fastställts, och som motsvarar teckningsoptionens marknadsvärde beräknat enligt Black & Scholes värderingsmodell. Betalning för tecknade teckningsoptioner ska i sin helhet erläggas kontant senast den 31 maj 2019. Styrelsen ska äga rätt att förlänga betalningstiden.
Om samtliga teckningsoptioner utnyttjas för teckning av aktier kommer Bolagets registrerade aktiekapital att öka med 50 000 kronor.
Varje teckningsoption ska medföra en rätt att teckna en ny aktie i bolaget till en teckningskurs motsvarande 200 procent av den volymvägda genomsnittskursen för bolagets aktie under den närmaste perioden om tio handelsdagar omedelbart före bolagsstämmans beslut om emission av teckningsoptionerna, dock som lägst aktiens kvotvärde. Den sålunda framräknade teckningskursen ska avrundas till närmaste tiondels öre varvid 0,05 öre ska avrundas nedåt.
Teckning av aktier med stöd av teckningsoptionerna ska ske i enlighet med villkoren för teckningsoptionerna från och med den 16 maj 2020 till och med den 16 maj 2021.
Aktie som tillkommit på grund av nyteckning medför rätt till vinstutdelning första gången på den avstämningsdag för utdelning som infaller närmast efter det att nyteckningen har registrerats hos Bolagsverket och aktierna införts i aktieboken hos Euroclear Sweden AB.
För teckningsoptionerna ska i övrigt gälla de villkor som framgår av dokumentet ”Villkor för teckningsoptioner 2019/2021 nr 2”.
Styrelsens ordförande, eller den styrelsen utser, ska äga rätt att vidta de smärre justeringar som kan bli erforderliga i samband med registrering av beslutet hos Bolagsverket och Euroclear Sweden AB.

En förutsättning för att deltagarna skall erbjudas att teckna teckningsoptioner är att dessa personer dessförinnan ingått ett s.k. hembudsavtal enligt vilket deltagarna ska vara förpliktade att erbjuda Bolaget att förvärva teckningsoptionerna, eller viss del av dessa, om teckningsoptionerna ska överlåtas till tredje man.
Vid fullt utnyttjande av teckningsoptionerna kommer aktiekapitalet att öka med 50 000 kronor. Det innebär att vid fullt utnyttjande av föreslagna teckningsoptioner kommer utspädningseffekten av de nya aktierna att motsvara cirka 1,3 procent av såväl aktierna som röstetalet i bolaget. Utspädningseffekten avseende aktierna och rösterna i bolaget i anledning av nytecknade aktier med stöd av teckningsoptionerna har beräknats genom att det totala antalet aktier som teckningsoptionerna berättigar till nyteckning av har dividerats med det totala antalet aktier efter det att teckningsoptionerna har utnyttjats för nyteckning av aktier.

Punkt 16 – Beslut om bemyndigande för styrelsen att emittera aktier, konvertibler eller teckningsoptioner
Styrelsen föreslår att årsstämman bemyndigar styrelsen att, vid ett eller flera tillfällen före nästa årsstämma, med eller utan avvikelse från aktieägarnas företrädesrätt, besluta om nyemission av aktier eller emission av konvertibler eller teckningsoptioner. Emission ska kunna ske mot kontant betalning, apport eller kvittning eller i övrigt på marknadsmässiga villkor som styrelsen bestämmer. Om styrelsen beslutar om emission utan företrädesrätt för aktieägarna så ska skälet vara att kunna bredda ägarkretsen, anskaffa eller möjliggöra anskaffning av rörelsekapital, öka likviditeten i aktien, genomföra företagsförvärv eller anskaffa eller möjliggöra anskaffning av kapital för företagsförvärv. Vid beslut om emissioner utan företrädesrätt för aktieägarna ska teckningskursen vara marknadsmässig vid tidpunkten för emissionsbeslutet. Antalet aktier, konvertibler eller teckningsoptioner som ska kunna ges ut med stöd av bemyndigande ska vara begränsat på så sätt att antalet aktier efter fulltecknad nyemission, fullt utnyttjande av teckningsoptioner eller full konvertering, inte ökar med mer än 10 procent av vid tidpunkten för denna kallelse utestående aktier.

Majoritetskrav

Beslut enligt punkterna 13 och 16 ovan förutsätter för sin giltighet att det biträds av aktieägare med minst två tredjedelar av såväl avgivna som de vid stämman företrädda aktierna. Bolagsstämmans beslut enligt punkterna 14 och 15 ovan förutsätter för sin giltighet biträde av aktieägare med minst nio tiondelar av såväl de avgivna rösterna som de vid stämman företrädda aktierna.

Upplysningar på stämman

Styrelsen och verkställande direktören ska, om någon aktieägare begär det och styrelsen anser att det kan ske utan väsentlig skada för Bolaget, lämna upplysningar om förhållanden som kan inverka på bedömningen av ett ärende på dagordningen och förhållanden som kan inverka på bedömningen av Bolagets ekonomiska situation.

Tillhandahållande av handlingar

Fullständiga beslutsförslag, redovisningshandlingar och revisionsberättelse, presentation av styrelseledamöter samt övriga handlingar enligt aktiebolagslagen kommer att hållas tillgängliga på Bolagets kontor med adress enligt ovan och på Bolagets hemsida minst tre veckor före stämman. Handlingarna sänds på begäran till aktieägare som uppger sin postadress. Handlingarna kommer även att hållas tillgängliga vid stämman.

_____________________

Uppsala i april 2019
AroCell AB (publ)
Styrelsen

För ytterligare information:
Michael Brobjer, VD
Telefon: +46(0)18 50 30 20
E-post: michael.brobjer@arocell.com

Denna information lämnades, genom Michael Brobjers försorg, för offentliggörande den 17 April, 2019 kl. 08.00.

Kort om AroCell

AroCell AB (AROC) är ett svenskt bolag som utvecklar standardiserade moderna blodtest för att stödja behandling, prognos och uppföljning av cancerpatienter. AroCells teknik är baserad på patenterade metoder för att mäta proteinet Tymidinkinas 1 (TK1) i blodprov. TK 210™ ELISA-testet ger värdefull information som kommer att kunna hjälpa kliniker att optimera behandlingsstrategier och prognostisera risken för återkommande tumörsjukdom vid monitorering och uppföljning av patienten. AroCell (AROC) är listat på Nasdaq First North med Redeye AB som Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90. För mer information, se www.arocell.com.

Attachment

Kallelse till Årstämma 2019-04-17 EN

AroCell AB (AROC NASDAQ Stockholm) announce today, in collaboration with Corgenix (Corgenix Inc., Colorado USA) that the AroCell TK 210 ELISA kit has been validated and approved for Thymidine Kinase 1 (TK1) measurements in human samples for preclinical and clinical use at the Corgenix laboratory facility in Colorado, USA.

This collaboration will make AroCell’s patented biomarker assay available both as a service and as in the already existing AroCell TK 210 ELISA kit for measurements of TK1 protein concentrations in human serum samples. This will provide maximum flexibility for our customers in the USA. It also extends the services that Corgenix offers in their CAP compliant CLIA-lab (Clinical Laboratory Improvement Amendments-lab).

Corgenix has over 25 years of experience in the In Vitro Diagnostic (IVD) industry focused on product development, manufacturing, regulation, distribution and contract services with a CAP/CLIA-lab based in Colorado, USA. A CAP/CLIA-lab is a clinical laboratory for human sample testing that follow CAP standards in USA. The AroCell TK 210 ELISA assay validation has been successfully completed and added to Corgenix laboratory test menu.

“The Corgenix Clinical Laboratory offers clients a regulated environment to understand unique biomarkers in their sample sets” says Kelly R Pitts, Ph.D., General Manager and Chief Scientific Officer at Corgenix. “Adding the AroCell TK1 assay to our menu further expands our ability to serve clients that are extending the boundaries of therapeutic approaches in oncology and beyond.”

“We are excited about this opportunity to collaborate with Corgenix by providing the service of measuring TK1 protein using AroCell´s TK 210 ELISA in their laboratory. This will strengthen our position in the U.S. and is in line with AroCell´s commercialization strategy to make AroCell TK 210 ELISA widely available. It will facilitate the use of TK1 measurements in clinical research as well as for drug development within the pharmaceutical industry” says Michael Brobjer, CEO of AroCell. “The successful validation of our kit into Corgenix facility also proves the robustness and easy handling of the kit.”

Thymidine Kinase 1 is a valuable tumor biomarker and the availability of a TK1 protein assays in a CLIA registered laboratory in the USA will make its application easier and more convenient for the pharmaceutical industry and clinical research.

AroCell TK 210 ELISA is the only available test to measure TK1 protein concentrations in serum blood and is CE marked in EU/ESS.

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, April 15, 2019 at 08:00.

About Thymidine Kinase 1

Thymidine Kinase 1 (TK1) is a key enzyme in DNA precursor synthesis. It is upregulated during the late G1 phase and early S phase of the cell cycle and its presence in cells is an indicator of active cell proliferation. Increased levels of TK1 in the blood can indicate active cell proliferation as a consequence of abnormal cell turnover and cell disruption triggered by for example therapeutic agents.

About CLIA Labs

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program. The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

About Corgenix

Corgenix, Inc. is a US-based company focused on In Vitro Diagnostic (IVD) development, manufacturing, and commercialization in the companion and complementary diagnostic space. With its CAP/CLIA laboratory (Corgenix Clinical Laboratory), it partners with diagnostic, pharmaceutical, biotechnology, device, and academic organizations to provide unique testing that facilitates discovery, development, clinical, and regulatory strategies leading to successful outcomes for its clients. For more information, www.corgenix.com

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure 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 monitoring of the disease. AroCell (AROC) is listed at Nasdaq First North with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.

For more information; www.arocell.com

Attachment

PM Corgenix lab ENG 2019-04-15

AroCell today announces that the Annual Report for 2018 is now available on the company’s website: www.arocell.com.

The Annual report is available on the following link: arocell.com/årsredovisning-2018

The report is available in Swedish only.

This information was submitted for publication through the agency of Michael Brobjer, April 12, 2019 at 11:30.

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

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

Annual report ENG PM 2019-04-12

AroCell announced today that the patent nr. 3083698 and titled” Monoclonal Anti-TK1 Antibodies” is granted by European Patent Office and will be published on April 10, 2019

The patent is referring to AroCell’s proprietary technology of specific and sensitive immunological measurement of Thymidine Kinase 1 in serum. More specifically, the monoclonal antibody, XPA210-Ar1, is covered in the patent

“We are delighted that the EPO has granted this patent. This reinforce AroCell’s position and increases our attractiveness as a business partner. We will continue to develop our portfolio of proprietary assets to further expand its business opportunities.” Says Michael Brobjer, CEO AroCell.

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, March 20, 2019 at 11:00.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

PM Patent EN 2019-03-20

In the corrected version of the press release we have added a link to the article.

The aim of the study was to investigate the diagnostic value of the AroCell TK 210 ELISA together with free PSA, pro PSA and PHI in differentiating prostate cancer from benign urological conditions.

The study with the title “The combination of AroCell TK 210 ELISA with Prostate Health Index or protease-specific antigen density can improve the ability to differentiate prostate cancer from noncancerous conditions” is published the peer-reviewed journal “The Prostate” and was performed in collaboration with Ljubljana University Medical Centre and the Maribor University Medical Centre, Ljubljana.

Serum samples from 140 patients with PSA values in the range between 2 and 10 µg/L were collected and the TK1 protein levels were determined using the AroCell TK 210 ELISA along with PSA-related parameters. The results showed that combination of TK1 with PSAD or TK1 with PHI has significantly higher sensitivity than those for the individual PSA-related biomarkers. These results further suggest that TK1 protein determinations together with PHI or PSAD could be a valuable tool in prostate cancer management.

“ We are delighted with the promising results in this first clinical study published on the performance of the TK210 ELISA in prostate cancer, The data suggests that the combination of serum TK1 levels with the Prostate Health Index and the PSA density can lead to increased diagnostic accuracy, which supports that the AroCell TK 210 ELISA can be a valuable tool in prostate cancer management”, says Michael Brobjer, AroCell CEO.

The article is can be found on the following link: https://onlinelibrary.wiley.com/doi/abs/10.1002/pros.23791

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, March 20, 2019 at 09.30.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

Corrected version Press Release The Prostate 2019-03-20 EN (004)

The aim of the study was to investigate the diagnostic value of the AroCell TK 210 ELISA together with free PSA, pro PSA and PHI in differentiating prostate cancer from benign urological conditions.

The study with the title “The combination of AroCell TK 210 ELISA with Prostate Health Index or protease-specific antigen density can improve the ability to differentiate prostate cancer from noncancerous conditions” is published the peer-reviewed journal “The Prostate” and was performed in collaboration with Ljubljana University Medical Centre and the Maribor University Medical Centre, Ljubljana.

Serum samples from 140 patients with PSA values in the range between 2 and 10 µg/L were collected and the TK1 protein levels were determined using the AroCell TK 210 ELISA along with PSA-related parameters. The results showed that combination of TK1 with PSAD or TK1 with PHI has significantly higher sensitivity than those for the individual PSA-related biomarkers. These results further suggest that TK1 protein determinations together with PHI or PSAD could be a valuable tool in prostate cancer management.

“ We are delighted with the promising results in this first clinical study published on the performance of the TK210 ELISA in prostate cancer, The data suggests that the combination of serum TK1 levels with the Prostate Health Index and the PSA density can lead to increased diagnostic accuracy, which supports that the AroCell TK 210 ELISA can be a valuable tool in prostate cancer management”, says Michael Brobjer, AroCell CEO.

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, March 20, 2019 at 09.30.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

Press Release The Prostate 2019-03-20 EN

An abstract from AroCell has been accepted for poster presentation on the American Association of Cancer Research 2019 (AACR 2019) held from March 29 to April 3 in Atlanta, Georgia, USA. The Study compares AroCell TK210 ELISA with TK-Liaison assay.

The study entitled “The Assay of Thymidine Kinase 1 in Sera from Subjects with Hematological and Solid Tumors with AroCell TK 210 ELISA: Comparison with TK-Liaison Assay and its Clinical Implications” by Jagarlamudi KK et al. shows that the AroCell TK 210 ELISA has a higher sensitivity for TK1 in sera from subjects with solid tumors and a similar sensitivity and specificity to the TK-Liaison assay for hematological malignancies. This indicates that the AroCell TK210 ELISA may facilitate the application of TK1 as a biomarker for solid tumors. Furthermore, the robustness and convenience of the ELISA not only overcomes the limitations of TK-Liaison but also widens the clinical applications of TK1 in cancer management.

The study included a large group of serum samples (N=273; blood donors (N=102), hematological tumors (N=51), breast cancer (N=60) and urological conditions (N=60)) analyzed for TK1 protein by TK 210 ELISA and TK1 activity by TK-Liaison assay.

The full abstract is available following the link below. https://www.abstractsonline.com/pp8/#!/6812/presentation/5087

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, February 28, 2019 at 10.30.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

PM AACR abstract 20190228 EN

The study with the title “The combination of AroCell TK 210 ELISA with Prostate Health Index (PHI) or PSA density can improve the ability to differentiate prostate cancer from non-cancerous conditions” will be published in the peer-reviewed journal “The Prostate”. The link to the article will be made available during March when the article has been published.

The aim of the study was to investigate the diagnostic value of the AroCell TK 210 ELISA together with free PSA, pro PSA and PHI in differentiating prostate cancer from benign urological conditions. This study was performed in collaboration with Ljubljana University Medical Centre and the Maribor University Medical Centre, Ljubljana.

“We are delighted with the promising results in this scientific study, which supports that the AroCell TK 210 ELISA can be a valuable tool in prostate cancer management”, says Michael Brobjer, AroCell CEO.

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, February 25, 2019 at 08:30.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

Press Release The Prostate 2019-02-25

Word from the CEO

”2018 has been an exciting year for AroCell with several major events. In April, AroCell signed a global non-exclusive license agreement with F. Hoffmann-La Roche Ltd (Roche). Roche is the market leader in diagnostics and the diagnostics part of the company has sales of just over SEK 100 billion and a global market share of around 20%. The license agreement gives Roche global sales rights for which AroCell receives royalties from future sales. Through the license agreement and the future cooperation with Roche, AroCell has very good prospects of making TK1 a standard biomarker in diagnostics and treatment primarily on analysis platforms intended for larger central laboratories.”

Michael Brobjer, CEO

Significant events during the reporting period 1 October – 31 December

AroCell signed a distribution agreement with the French company Eurobio Scientific, for distribution of AroCell TK 210 ELISA in France and Switzerland
Michael Brobjer stared as CEO on December 8, 2018
Anders Hultman started as CFO on December 1, 2018
AroCell’s Chief Scientific Officer, Professor Staffan Eriksson, presented preliminary results from the U-CAN TK1 lymphoma study at the International Society of Oncology Biomarkers (ISOBM) in Hamburg. The preliminary results suggest that TK 210 ELISA may be used for monitoring the effect of therapy of DLBCL patients under rituximab + CHOP treatment, and for determination of overall survival rate
AroCell presented a poster at ISOBM in Hamburg Demonstrating Enhanced Diagnostic Value When Using AroCell’s Proprietary Sample Preparation Method
The U.S. Patent and Trademark Office granted AroCell´s patent US 10,100,128 titled ”Monoclonal Anti-TK1 Antibodies”

Significant events after the reporting period

AroCell launched a new website. The goal with the new website is to facilitate for customers, business partners and investors to find relevant information about AroCell.
AroCell signed a distribution agreement with the Beijing based company Gongyingshi for the promotion and distribution of the AroCell TK 210™ ELISA in China.

Reporting period 1 October – 31 December 2018

Net sales were 0 (209) KSEK
Loss before financial items was -5 462 (-5 757) KSEK
Cash flow from operating activities was -4 854 (-2 947) KSEK
Earnings per share before and after dilution were -0,14 (-0,20) SEK
Cash and cash equivalents were at the end of the period 29 734 (17 249) KSEK

Reporting period 1 January – 31 December 2018

Net sales were 782 (502) KSEK
Loss before financial items was -20 757 (-17 266) KSEK
Cash flow from operating activities was -16 407 (-15 235) KSEK
Earnings per share before and after dilution were -0,59 (-0,60) SEK
Cash and cash equivalents were at the end of the period 29 734 (17 249) KSEK

Year-End report 2018 (available in Swedish only) https://arocell.com/sv/news/year-end-report-2018/

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, February 21, 2019 at 08:30.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

.

Attachment

PM Year-end report 2019 EN

Today AroCell publishes a short video interview with Michael Brobjer, CEO, and his reflections on his first months at Arocell.

The video is available through the link below, AroCell website, and on Financial Hearings web channel. The video is available in Swedish, subtitles will be added shortly.

Video: https://tv.streamfabriken.com/2019-02-12-arocell

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

This information was submitted for publication through the agency of Michael Brobjer, February 13, 2019, at 12:00.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

CEO video Press Release EN 20190213

Today AroCell is launching its new website. The goal with the new website is to facilitate for our customers, business partner, and investors to find relevant information about AroCell.

The website (arocell.com) informs about precision monitoring in cancer care and the potential clinical utility of measuring the concentration of TK1 during cancer treatment. Thymidine kinase 1 (TK1) is a potential biomarker during cancer treatment. The determination of the TK1 concentration in serum is simple using AroCell TK 210 ELISA, by using a blood sample from the patient, making timely decisions possible during treatment of cancer patients.

“Communicating with our customers, business partners, shareholders and investors is important for AroCell and our web is our major channel for this communication. I’m very pleased how the new website facilitates for our stakeholders to find relevant information about AroCell, our way forward and our product TK210 ELISA” says Michael Brobjer, CEO of AroCell.

The new website is designed with user-friendly navigation in mind, helping stakeholders to easy navigate through the site and find relevant information. The web has also got a face lift and a new fresh look.

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

This information was submitted for publication through the agency of Michael Brobjer, February 1, 2019 at 13:30 hours.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

New website launched 20190201_EN

AroCell became this week a member of SwedenBIO, an industry organization for Swedish Life Science companies. The purpose of the membership is to take part in the broad life science development in Sweden and to participate in SwedenBIOs networks and network meetings.

AroCell develops a biomarker test that can support the treatment, prognosis, and follow-up of cancer patients. SwedenBIO has a large network that includes everything from researchers, life science companies, financiers and various service companies working together for a competitive life science industry in Sweden. It contributes to an innovative environment for the entire life science industry, and AroCell is now a part of it.

"We are pleased to be part of the SwedenBIOs network and promote the Swedish Life Science growth. It is important for us to operate both nationally and internationally and to establish strong relationships with both oncology and other healthcare companies, "says Michael Brobjer, CEO of AroCell.

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

This information was submitted for publication through the agency of Michael Brobjer, January 25, 2019 at 15:30 hours.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: Certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

PM SwedenBio ENG 2019-01-25

AroCell AB (publ) announced today that a distribution agreement has been signed with the Beijing based company Gongyingshi for the promotion and distribution of the AroCell TK 210™ ELISA in China.

The pharmaceutical and biotechnological industries are growing rapidly in China making it an attractive market for innovative biomarker assays such the AroCell TK 210 ELISA. Our TK 210 ELISA measures concentration levels of thymidine kinase 1 (TK 1) in blood samples and provides valuable information about cell proliferation and disruption in patients with cancer tumors. But also, during patient monitoring of cancer treatment, TK 210 ELISA may support clinicians to optimize treatment and estimate the risk of recurrence.

“We are looking forward to this new collaboration with Gongyingshi for the distribution and promotion of AroCell TK 210 ELISA”, says Michael Brobjer, AroCell’s CEO. Gongyingshi is well established as a leading internet + biomedical research service provider on the Chinese market with over 9000 customers, an established sub-distributor network and an in-house expert sales team. Gongyingshi´s web platform provides a one-stop shop for biomedical researchers in China and they are in an excellent position to promote the AroCell TK 210 ELISA to the Chinese market. Supporting AroCell´s commercialization strategy to make AroCell TK 210 ELISA widely available and to facilitate the use of the product in clinical research, routine clinical laboratories as well as for drug development within the pharmaceutical industry.

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

AroCell is obliged to make public this information pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of Michael Brobjer, January 15, 2019 at 08:00.

About AroCell

AroCell AB (AROC) is a Swedish company that develops standardized modern blood tests to support the prognosis and follow up of cancer patients. AroCell's new technology is based on patented methods to measure Thymidine Kinase 1 (TK1) protein levels 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 with Redeye AB as Certified Adviser: certifiedadviser@redeye.se, +46 (0)8 121 576 90.
For more information; www.arocell.com

Attachment

Gongyingshi EN 2019-01-15