Comments from Jan Stålemark, CEO
AroCell has now achieved an historical milestone. Our TK 210 ELISA test kit has been fully developed, achieved the CE-mark and is now commercially available, primarily for research and clinical development. It is the first and only ELISA-kit on the market that can measure TK 1-protein in serum from a standard blood sample. This fully enables us to initiate the next step in our plan - the critical and final clinical validation to confirm the clinical value of our product. We have already demonstrated how well the product has worked in smaller clinical studies, and established that the sensitivity is now sufficient to be used for several different types of cancers. The clinical development and validation is necessary in order to launch the product on the global in vitro diagnostic cancer market.
Our product addresses several clinical needs, including early detection and prognosis of cancer, monitoring and optimization of cancer treatment, and follow-up post treatment to identify disease relapse. This is made available in a comfortable manner to the patient by means of a simple blood test. Analysis of the TK 210 ELISA tests is conducted in a standard manner on established equipment which is available in all modern clinical chemical laboratories. No special training of laboratory staff is required as the method of analysis is already standardized.
Our objective is to introduce a fully validated TK 210 ELISA on the global in vitro diagnostic market. In parallel with initiating the clinical validation we are also proceeding with marketing and initial sales of TK 210 ELISA, primarily to the clinical research customer segment.
We have determined that this preferential rights issue will provide us with enough resources to complete the clinical development of TK 210 ELISA and will create significant value for an established in vitro diagnostic company in the large and rapidly-changing market of cancer diagnostics.
Our intention of changing the share listing to the Nasdaq First North exchange is to provide AroCell with a greater exposure in order to attract institutional and international investors.
Motive for the preferential rights issue
AroCell registered TK 210 ELISA for CE mark at the Swedish Medical Products Agency in September 2015. The CE mark is a symbol of quality and is an essential step for the continued clinical validation need to obtain full clinical acceptance and commercial launch of a diagnostic product. AroCells objective is to prepare and launch the CE-marked TK 210 ELISA product for measurement of concentration of TK 1-protein in serum during the fourth quarter of 2015. TK 1 is a biomarker for unregulated cell turnover within the body, for example in progressive diseases such as cancer.
AroCell intends to initially utilize the preferential rights equity for clinical studies to establish clinical evidence for TK 210 ELISA, and thereafter for optimization and continued development of the product to achieve even better performance and quality, and to optimize the production process to reduce production costs, as well as establish TK 210 ELISA in health care reimbursement systems and for marketing and sales activities.
Subscription and guarantee obligations
Subscription agreements for approximately 3.9 MSEK (from members of the board of directors, management and larger shareholders) and guarantee agreements for approximately 48.3 MSEK have been received. The subscription and guarantee obligations amount to approximately 52.2 MSEK therewith, comprising a fully guaranteed preferential rights issue. Equity however has not been verified in advance. The guaranteed issues comprise a total compensation of approximately 3.9 MSEK.
Summary of rights issue
* The subscription period will run from 18 November 2015 to 2 December 2015
* The subscription price amounts to 10.00 SEK per share, brokerage fees will not be charged.
* Record date for participation in the rights issue with preferential rights is November 13, 2015. Each share in AroCell on the record date entitles to one (1) subscription right. Nine (9) subscription rights entitle to subscription of two (2) new shares.
*Record date for participation is November 13, 2015. The last date of share trading including right to obtain preferential subscription is 11 November 2015, and the first day excluding right to obtain preferential subscription is November 12, 2015.
*Trading in subscription rights will take place on the AktieTorget exchange during the period of November 18-30 2015.
*Trading in paid subscribed shares will take place on the AktieTorget exchange during the period from November 18 2015 until the rights issue has been duly registered at the Swedish Companies Registration Office. This registration is calculated to take place in mid-January 2016.
*The total number of shares in the rights issue comprises 5 213 546 shares.
*The total number of shares prior to the rights issue comprises 23 460 960 shares.
Conditions and instructions as well as additional information pertaining to subscription agreements and grantees will be published in a prospectus that will be made available at the introduction of the subscription period.
Redeye AB are acting as financial advisors in connection with the preferential rights issue. The company has also authorized Corpura AB as advisors. Fredersen Advokatbyrå AB is acting as legal advisor to AroCell AB.
For further information:
Jan Stålemark, CEO
AroCell AB (pub)
About AroCell AB (publ)
AroCell AB 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 TK1 protein levels, which provide valuable information about the speed of cell turnover. A tumor has high cell turnover (speed of cell division and cell death) and as a result TK1 can be detected in the blood with a simple laboratory test, called TK 210 ELISA. The test provides valuable clinical information for prognosis and optimization of treatment strategy. The test may also be used for monitoring disease relapse. For more information, please see www.arocell.com . AroCell AB is listed at AktieTorget and has about 2 300 shareholders.