The nomination committee, which is appointed in accordance with the principles adopted by the annual general meeting on May 6, 2020, consists of:
 
• Jon Eiken, represents his own shares
• Michael Lönn, represents his own shares
• Mikael Jakobsson, represents his own shares
• Claes Post (chairman of the board of directors)
 
The nomination committee shall, before the annual general meeting 2021, prepare a proposal for the election of chairman and other members of the board of directors, the election of chairman of the annual meeting, the election of auditors, the determination of fees and matters pertaining thereto.
 
For more information please visit:
Nomination committee - AroCell TK 210 ELISA
 
Shareholders who wish to submit proposals to the nomination committee for the annual general meeting 2021 can do so by e-mail to info@arocell.com (header ”AroCell's nomination committee”). Proposals should be submitted to the nomination committee before January 31st, 2021.
 
For further information, please contact:
Anders Hultman, CFO at AroCell
Email: anders.hultman@arocell.com
 
The information was submitted for publication, through the agency of the contact person set out above, at 9.00 a.m. on December 14, 2020.

A word from the CEO
” Our work to ensure a positive outcome of our 510(k) submission to the FDA and thus the opportunity to sell the AroCell TK 210 ELISA as an IVD product in the US market continues unchanged. We have had an active dialogue with the FDA regarding our submission and the work has progressed according to plan. However, the FDA announced in October that they had to make certain priorities, which meant that the review of our 510(k) submission would initially be postponed for 90 days. It is mainly the strained situation around Covid-19 that makes the FDA need to make these priorities. It is of course a disappointment for AroCell that there will be a delay in the process of clearance of our 510(k). The work of preparing for the launch of AroCell TK 210 ELISA with primarily reimbursement plans, market access strategy, and launch activities continues. Our assessment remains that we can obtain clearance of our AroCell TK 210 ELISA from the FDA no later than the end of 2021.”

Michael Brobjer, CEO

Reporting period July 1st - September 30th

• Net sales were 0 (120) KSEK
• Loss before financial items was -6 371 (-4 500) KSEK
• Cash flow from operating activities was -5 580 (-2 806) KSEK
• Earnings per share before and after dilution were -0,08 (-0,11) SEK
• Cash and cash equivalents were at the end of the period 45 848 (18 629) KSEK

Reporting period January 1st - September 30th

• Net sales were 64 (323) KSEK
• Loss before financial items was -18 040 (-14 702) KSEK
• Cash flow from operating activities was -15 068 (-11 268) KSEK
• Earnings per share before and after dilution were -0,25 (-0,37) SEK
• Cash and cash equivalents were at the end of the period 45 848 (18 629) KSEK

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

• A patent was granted by the Japanese Patent Office. The patent relates to AroCell's proprietary monoclonal antibodies used to determine the concentration of Thymidine kinase 1 in serum samples. These antibodies are used in AroCell TK 210 ELISA.

• A patent was granted by the European Patent Office (EPO). The patent relates to AroCell's proprietary monoclonal antibodies used to determine the concentration of Thymidine kinase 1 in serum samples. These antibodies are used in AroCell TK 210 ELISA.

• AroCell implemented a change in the company's management. Cecilia Ahlin ended her employment as Chief Medical Officer (CMO). Gunnar Steineck, professor of oncology, was appointed as interim CMO.

• AroCell initiated a new collaboration with the University of Rome la Sapienza to evaluate Thymidine kinase 1 (TK1) and PSA in response to biomarkers after hormone therapy in castration-resistant prostate cancer patients. The goal is to help physicians get better treatment data by measuring TK1 as a response biomarker in castration-resistant metastatic prostate cancer patients who have been treated with hormone therapy.

• AroCell has had a dialogue with the US Food and Drug Administration (FDA) regarding the 510 (k) submission that the company submitted on May 26, 2020.

Events after the reporting period

• The FDA reports delays in the timeline for reviewing 510(k) applications, due to a large number of Emergency Use Authorization (EUA) requests they have received in in-vitro diagnostics (IVDs) due to COVID 19. Redistributions of staff and resources are expected to affect the timeline for reviewing applications. The FDA estimates the delay at about 90 days, which will delay the review of AroCell's 510(k) application.

• AroCell announced a new article published in the Journal of Immunological Methods. The article indicates that it is possible to design diagnostic algorithms for biomarkers that can help distinguish Mycoplasma pneumonia from other respiratory infections caused by bacteria or viruses.

Interim report January 1st - September 30th, 2020 (available in Swedish only) (Link)

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

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

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

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

A word from the CEO
"The second quarter has been largely characterized by the Covid-19 pandemic and measures have been taken to prevent the spread of the virus. For AroCell, this has meant changes in office and laboratory procedures, no physical meetings with customers or partners, and a limited possibility for meetings with our clinical partners. This has of course affected our sales of AroCell TK 210 ELISA negatively but we are now seeing an increased number of contacts and interest in our product. However, the business has been able to continue with undiminished force and the focus has been on the submission of 510 (k) clearance to the FDA in the US and strengthening of our IP portfolio.”

Michael Brobjer, CEO

Reporting period April 1st - June 30th

• Net sales were 0 (127) KSEK
• Loss before financial items was -6 195 (-4 915) KSEK
• Cash flow from operating activities was -4 419 (-4 060) KSEK
• Earnings per share before and after dilution were -0.08 (-0.12) SEK
• Cash and cash equivalents were at the end of the period 51 428 (21 435) KSEK

Reporting period January 1st - June 30th

• Net sales were 64 (203) KSEK
• Loss before financial items was -11 669 (-10 202) KSEK
• Cash flow from operating activities was -9 488 (-8 462) KSEK
• Earnings per share before and after dilution were -0.16 (-0.26) SEK
• Cash and cash equivalents were at the end of the period 51 428 (21 435) KSEK

Significant events during the reporting period April 1st - June 30th

• A new peer-reviewed article has been published in the journal BioTechniques, where AroCell TK 210 ELISA shows higher sensitivity compared to other TK1 ELISA assays.

• AroCell filed an international (PCT) patent application regarding the use of Thymidine Kinase 1 (TK1) in predicting the presence of and diagnosing Mycoplasma pneumonia, and in the classification of respiratory infections.

• New peer-reviewed scientific article on TK1 has been published in the journal BMC Cancer. The results have shown that TK1 has the potential to be used as a biomarker for early treatment response in patients with breast cancer.

• In May, AroCell submitted an application to the US Food and Drug Administration (FDA) for 510 (k) clearance of the AroCell TK 210 ELISA kit.

• AroCell has extended the CE mark for AroCell TK 210 ELISA with clinical use in cancer treatment, such as breast cancer.

• AroCell has received a letter of approval from the European Patent Office (EPO) for the patent application for AroCell's proprietary monoclonal antibodies used in AroCell TK 210 ELISA.

• Two posters about TK1 and AroCell TK 210 ELISA have been presented and published online at the American Association of Cancer Research 2020 (AACR 2020).

Significant events after the reporting period

• The patent application for AroCell's proprietary monoclonal antibodies has been granted by the Japanese Patent Office.

• AroCell has announced the change in management. Cecilia Ahlin ended her employment as Chief Medical Officer and Gunnar Steineck, professor in oncology was appointed interim CMO.

• AroCell has initiated a new collaboration with the University of Rome la Sapienza to evaluate the role of Thymidine kinase 1 (TK1) and PSA as response biomarkers after hormone treatment in castration-resistant prostate cancer patients.

Interim report January 1st - June 30th, 2020 (available in Swedish only) (LINK)

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

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

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

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

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

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

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

A word from the CEO
“Like most other companies, AroCell has had challenges with the Corona pandemic. The measures all around the world that have been taken to prevent the spread of the virus have affected us all. For AroCell, this has meant fewer opportunities for meetings with our clinical partners and lower sales of our kit. However, internal operations have been able to continue without interruption. A major focus during this period has therefore been on strengthening our IP portfolio and on the work to get AroCell TK 210 ELISA approved by the FDA in the USA."

Michael Brobjer, CEO

Reporting period 1st January – 31st March 2020

• Net sales were 64 (76) KSEK
• Loss before financial items was -5 474 (-5 287) KSEK
• Cash flow from operating activities was -5 068 (-4 402) KSEK
• Earnings per share before and after dilution were -0.08 (-0.13) SEK
• Cash and cash equivalents were at the end of the period 55 847 (25 332) KSEK

Significant events during the reporting period 1 July – 31st March

• AroCell patent no 105980407 and titled “Monoclonal anti-TK1 antibodies” were granted by China National Intellectual Property Administration (CNIPA). The patent relates to AroCell’s proprietary monoclonal antibodies used for determining the Thymidine kinase 1 concentration in serum samples.

• AroCell patent no. 10.551.385 regarding the method of determining the likelihood of cancer relapse was granted by United States Patent and Trademark Office.

• Cecilia Ahlin joined the management team as Chief Medical Officer. Cecilia will lead and develop AroCell’s clinical strategy with a focus on getting more clinical evidence for the use of TK1 as a biomarker in cancer treatment.
• AroCell submitted a patent application regarding the use of an immunoassay of Thymidine Kinase 1 (TK1) to enable more accurate prognoses in prostate cancer patients. The patent is based on research together with the University of Tampere.

• AroCell initiated a collaboration with the University Hospital of Pisa to evaluate the AroCell TK 210 ELISA for Thymidine Kinase 1 (TK1) as a prognostic biomarker in subjects with liver cancer. The aim of the study is to determine the prognostic value of TK1 in combination with imaging techniques to improve prognoses and monitoring in subjects with liver cancer

• An abstract from AroCell was accepted for poster presentation on the American Association of Cancer Research 2020 (AACR 2020).

• A new peer-reviewed article from AroCell was accepted for publication in the BioTechniques journal. The article describes a comparison of AroCell TK 210 ELISA with Abcam TK1 ELISA.

• Marianne Alksnis was employed as Senior Sales Director. Marianne will be leading Arocell's sales efforts and continue to develop the global distributor network.

Significant events after the reporting period

• A new peer-reviewed article was published in the BioTechniques journal, were AroCell TK 210 ELISA shows higher sensitivity compared to other TK1 ELISA assays

• AroCell AB filed an international (PCT) application at the Swedish Patent Office (PRV) regarding the use of Thymidine kinase 1 (TK1) in predicting the presence of and diagnosing Mycoplasma pneumonia, and in the classification of respiratory infections.

Interim report January 1st to March 31st, 2020 (available in Swedish only) (Link)

AroCell AB (publ) (”Bolaget”) höll idag den 6 maj 2020 i Uppsala sin årsstämma för verksamhetsåret 2019, 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 2019 och balansräkningen per den 31 december 2019.

Resultatdisposition
I enlighet med styrelsens förslag beslutade årsstämman att disponera vinstmedlen så att ansamlad förlust om 106 717 092 kronor samt överkursfond om 173 432 440 kronor balanseras i ny räkning.

Ansvarsfrihet
Årsstämman beviljade styrelsens ledamöter och verkställande direktören ansvarsfrihet för räkenskapsåret 2019.

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 fyra styrelseledamöter och inga suppleanter. Årsstämman omvalde Agneta Franksson, Claes Post och Karin Eriksson-Widblom samt nyval av Eva Nordström. 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.

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 20% av vid tidpunkten för kallelsen utestående aktier.

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

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

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

The Annual report is available on the following link: arocell.com/årsredovisning-2019

The report is available in Swedish only.

This information was submitted for publication through the agency of Michael Brobjer, April 3, 2020, at 10:30.

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

About AroCell
AroCell AB (publ) 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

Aktieägarna i AroCell AB (publ), org.nr 556596–6107 (”Bolaget”) kallas härmed till årsstämma torsdagen den 6 maj 2020, kl. 11.00 i lokalen Karin Boye på Virdings allé 32 B i Uppsala. Registreringen börjar kl. 10.30 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 onsdagen den 29 april 2020 (avstämningsdagen), och

• dels anmäla sitt deltagande så att denna är Bolaget tillhanda senast kl. 16:00 onsdagen den 29 april 2020, under adress AroCell AB (publ), Virdings allé 32B, 754 50 Uppsala alternativt e-mail till bolagsstamma2020@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 29 april 2020. 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 29 april 2020. 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 75 712 408 aktier med en röst vardera.

Förslag till dagordning
1. Öppnande och val av ordförande vid stämman
2. Upprättande och godkännande av röstlängd
3. Val av en eller två justeringspersoner
4. Prövning av om stämman blivit behörigen sammankallad
5. Godkännande av dagordning
6. VD-presentation
7. Framläggande av årsredovisning och revisionsberättelse
8. Beslut angående
a. Fastställande av resultaträkningen och balansräkningen
b. Dispositioner beträffande Bolagets resultat enligt den fastställda balansräkningen
c. Ansvarsfrihet åt styrelseledamöterna och den verkställande direktören
9. Beslut om antal styrelseledamöter
10. Fastställande av arvode till styrelsen och revisorerna
11. Val av
a. Styrelseledamöter och styrelseordförande
b. Revisorer
12. Beslut om valberedning inför nästa årsstämma
13. Beslut om bemyndigande för styrelsen att emittera aktier, konvertibler eller tecknings-optioner
14. 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 106 717 092 kronor samt överkursfond om 173 432 440 kronor balanseras i ny räkning.

Punkt 9 – Beslut om antal styrelseledamöter
Valberedningen föreslår att antalet styrelseledamöter ska uppgå till fyra 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 Agneta Franksson, Claes Post och Karin Eriksson-Widblom, samt nyval av Eva Nordström, 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 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 20 procent av vid tidpunkten för denna kallelse utestående aktier.

Majoritetskrav
Beslut enligt punkten 13 ovan förutsätter för sin giltighet att det biträds av aktieägare med minst två tredjedelar av såväl avgivna 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 2020
AroCell AB (publ)
Styrelsen

A word from the CEO
“In 2019, AroCell has been transformed from a research-oriented company to a commercially oriented company. The change began at the turn of the year and is now evident in all our operations. At the same time, there is much left work to do and we continue to be a little better at everything we do. But when I look back on this year, I can see that AroCell
stands much stronger now than a year ago, and that on all fronts. I said when I started a year ago that we would improve communication to the market, increase sales and build value for the company. We have in all of these points come a good bit further. Mainly because several clinical studies have been started, more distributors have been contracted and we have participated in several different conferences and meetings where we were given the opportunity to present AroCell and our AroCell TK 210 ELISA.”

Michael Brobjer, CEO

Reporting period 1st October – 31st December 2019

• Net sales were 120 (0) KSEK
• Loss before financial items was -6 034 (-5 462) KSEK
• Cash flow from operating activities was -4 998 (-4 854) KSEK
• Earnings per share before and after dilution were -0.15 (-0.14) SEK
• Cash and cash equivalents were at the end of the period 13 631 (29 734) KSEK

Reporting period 1st January – 31st December 2019

• Net sales were 443 (782) KSEK
• Loss before financial items was -20 736 (-20 757) KSEK
• Cash flow from operating activities was -16 103 (12 485) KSEK
• Earnings per share before and after dilution were -0.53 (-0.59) SEK
• Cash and cash equivalents were at the end of the period 13 631 (29 734) KSEK

Significant events during the reporting period October 1st – December 31st

• AroCell had a pre-submission meeting with the FDA for the clearance of the product AroCell Tk 210 ELISA. The path to FDA clearance was discussed and defined. The aim of the meeting was to ensure that there was a common view of the documentation needed for the application.

• AroCell performed an issue of shares with preferential rights for existing shareholders of SEK 39.4m as well as a directed share issue of SEK 15m. 55 per cent of the rights issue, was subscribed for by the exercise of subscription rights (including subscription undertakings). Furthermore, approximately 5 per cent of the rights issue was subscribed for without subscription rights. The issues will fund the work of obtaining FDA approval of AroCell TK 210 ELISA in the US and thereof associated activities.

• AroCell initiated a collaboration with Tampere University Hospital (TAYS) to evaluate AroCell’s TK 210 ELISA for Thymidine Kinase 1 (TK1) as a prognostic biomarker in subjects with metastatic prostate cancer.

Significant events after the reporting period

• The AroCell patent no 105980407 and titled “Monoclonal anti-TK1 antibodies” was granted by China National Intellectual Property Administration (CNIPA). The patent relates to AroCell’s proprietary monoclonal antibodies used for determining the Thymidine kinase 1 concentration in serum samples.

• The AroCell patent no. 10.551.385 regarding the method of determining a likelihood of cancer relapse was granted by the United States Patent and Trademark Office.

• Cecilia Ahlin was employed as Chief Medical Officer. Cecilia will lead and develop AroCell’s clinical strategy with focus on getting more clinical evidence for the use of TK1 as a biomarker in cancer treatment

• AroCell submitted a patent application regarding the use of an immunoassay of Thymidine Kinase 1 (TK1) to enable more accurate prognoses in prostate cancer patients. The patent is based on research together with the University of Tampere.

• AroCell initiated a collaboration with the University Hospital of Pisa to evaluate the AroCell TK 210 ELISA for Thymidine Kinase 1 (TK1) as a prognostic biomarker in subjects with liver cancer. The aim of the study is to determine the prognostic value of TK1 in combination with imaging techniques to improve prognoses and monitoring in subjects with liver cancer.

• An abstract from AroCell was accepted for poster presentation on the American Association of Cancer Research 2020 (AACR 2020) to be held April 24-29 in San Diego, California, USA.

Year-End Report January 1st to December 31st, 2019 (available in Swedish only) (LINK)

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

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

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

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

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

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

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

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

Rights issue
Through the rights issue of shares, AroCell raises approx. SEK 39.4 million before deduction of issue related costs.
The rights issue has been registered with the Swedish Companies Registration Office (Sw. Bolagsverket) and the last day of trading in AroCell’s BTA will be Tuesday, January 28th, 2020. The stop day will be Thursday, January 30th, 2020. Shares are estimated to be delivered on the shareholders’ account Monday, February 3rd, 2020.

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.

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.