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.

Mycoplasma pneumonia is caused by the bacterium Mycoplasma pneumoniae, infecting the lower respiratory tract leading to atypical pneumonia. Current diagnostic tests of Mycoplasma pneumoniae infections of the respiratory tract such as PCR and serology are either somewhat unreliable or slow to perform. Thus, they do not meet the clinical needs of accurate and fast diagnosis, that the therapeutic decisions rely on.
 
The newly published article demonstrates that measuring Thymidine kinase 1 (TK1) concentration alone can distinguish Mycoplasma pneumonia from other bacterial infections. In fact, TK1 in combination with other infection biomarkers, such as IP-10 or P-HNL, showed even higher accuracy for diagnosis of Mycoplasma pneumonia. This shows that TK1 is a potentially promising tool for therapeutic decision-making, not only in the cancer field but also for Mycoplasma pneumonia, especially when used in combination with other markers. The development of assays based on this kind of algorithms could be clinically useful tools in therapeutic decision-making.
 
AroCell has earlier this year applied for a patent based on that respiratory infection in humans caused by Mycoplasma pneumoniae lead to significantly increased levels of Thymidine kinase 1 protein, as measured with AroCell’s CE-marked serum TK1 protein assay, AroCell TK 210 ELISA.

“We are happy to have achieved these exciting results that in combination with our patent application opens up new fields for AroCell using TK1 in other clinical areas besides oncology. We have been evaluating the use of TK1 as a marker for certain infectious diseases for some time now. This has opened new possibilities for AroCell.”, says Michael Brobjer, CEO.

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.

The patent application relates to AroCells proprietary monoclonal antibodies used for determining the Thymidine kinase 1 concentration in serum samples. These antibodies are used in the AroCell TK 210 ELISA kit.
 
“We are thrilled that we got a decision to grant for this patent in Europe. This means that the chance is high for the patent to be granted in the near future. This will reinforce our patent position in Europe and increase AroCells 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 TK1 protein levels will be measured in serum samples using AroCell TK 210 ELISA. Serum samples will be collected from 50 patients with an advanced metastatic prostate cancer diagnosis and 40 healthy controls. TK1 and PSA will be measured at the time of the diagnosis and 1, 3, and 6 months after the start of treatment. The objective is to help clinicians obtain more information by measuring the TK1 as a responsive biomarker in castration-resistant metastatic prostate cancer patients treated with hormone therapy.
 
The study will be executed in collaboration with Dr. Emanuela Anastasi at the Department of Molecular Medicine, University of Rome la Sapienza, Italy.
 
“We are excited to collaborate with University of Rome la Sapienza”, 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’s quality of life”.

“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 patent application relates to AroCell’s proprietary monoclonal antibodies used for determining the Thymidine kinase 1 concentration in serum samples. These antibodies are used in the AroCell TK 210 ELISA kit.
 
“We are delighted that this patent has been granted by the Japanese Patent Office. This reinforces our patent position and increases AroCell’s attractiveness as a business partner in Asia.” says Michael Brobjer, CEO AroCell.

The content of the posters has previously been released as an abstract and now the complete posters can be read on AACR’s website.

The first poster has the title “Serum Thymidine Kinase 1 levels predict prostate cancer-specific survival” and is based on a study by Teemu Murtola of Tampere University Hospital. The poster describes the use of Thymidine Kinase 1 as a prognostic marker for the progression of prostate cancer after diagnosis.

The second poster's title is “Evaluation of TK1 protein changes using the AroCell TK 210 ELISA in an acute myeloid leukemia (AML) xenograft model during 5-fluoruracil treatment.” by Jagarlamudi KK et al, demonstrates how the immunoassay of Thymidine Kinase 1 can be used to study anti-cancer drug effects in a clinically relevant animal model.

Link to AACR Posters.

The patent application relates to AroCells proprietary monoclonal antibodies used for determining the Thymidine kinase 1 concentration in serum samples. These antibodies are used in the AroCell TK 210 ELISA kit.
 
“We are thrilled that we have got a Notice of Allowance in Europe for this patent application. This means that the chance is high for the patent to be granted in the near future. This will reinforce our patent position in Europe and increase AroCells 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.

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.

The patent application relates to AroCell’s proprietary monoclonal antibodies used for determining the Thymidine kinase 1 concentration in serum samples. These antibodies are used in the AroCell TK 210 ELISA kit.
 
“We are delighted that we have got a Notice of Allowance in Japan for this patent application. This means that the chance is high for the patent to be granted in the near future. This will reinforce our patent position and attractiveness as a business partner in Asia. 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.

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.”

Early evaluation of tumor response would facilitate individualized treatment, with inefficient chemotherapy interrupted or changed. In the present PROMIX study, measurements of the serum level of TK1 (sTK1) were performed in patients receiving treatment with Epirubicin and Docetaxel before surgery. The cell loss metric, defined as the ratio between sTK1 and tumor volume, obtained after two treatment cycles, correlated significantly with the status of the tumor at surgery after six cycles. This indicates that the use of the sTK1-based metric gives an early indication of the treatment response in breast cancer.
 
The study was performed on serum from 104 patients with newly detected, localized breast cancer in a neoadjuvant Phase II trial. Serum samples had been obtained before, and 48 hours after, each cycle of chemotherapy. The concentration of TK1 in the serum was measured using the AroCell TK 210 ELISA. 
 
The results of the study lead to the conclusion that TK1 has the potential of being used as a biomarker for early treatment response in patients with breast cancer.
 
“This study tells us that TK1 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 with these exciting results. Early detection of therapy response is crucial in selecting the correct treatment for every individual patient” says Michael Brobjer, CEO. “The implication of this finding is that it could aid to avoid patients undergoing chemotherapy treatment to which they may not respond”. Michael continues.
 
“The large differences between patients in the response to cytotoxic treatment, combined with the costs and suffering of such treatment, warrant the development of methods for early evaluation of the response in each individual. The correlation between an early sTK1-based measure of cell loss and the outcome of treatment four months later suggests that the metric is a manifestation of an important biological tumour property, a property that may differ considerably between patients but is comparatively stable in the individual.”, says Bernhard Tribukait, author of the article.

Link to the article.

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 article is entitled “AroCell TK 210 ELISA for determination of TK1 protein: Age-related reference ranges and comparison with other TK1 assays”, by Kiran Jagarlamudi et al. The study aims to establish the age-related reference ranges of TK1 protein levels in sera from apparently healthy individuals (N=264), and comparison of AroCell TK 210 ELISA with Abcam TK1 ELISA using sera from patients with hematological malignancies (N=62) as well as solid tumors (N=30).
 
Results visualize that the AroCell TK 210 ELISA has higher sensitivity than the Abcam TK1 ELISA for differentiating hematological malignancies and solid tumors from apparently healthy individuals. These results strongly indicate that the AroCell TK210 ELISA is accurate and sensitive enough to be a valuable tool in cancer management compared to other TK1 assays.
 
“We are happy with this publication and the strong results that show that the AroCell TK 210 ELISA kit has high accuracy and sensitivity compare to other methods”, Michael Brobjer CEO at AroCell.

The article can be found here: https://www.future-science.com/doi/10.2144/btn-2019-0148

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

The ongoing Corona pandemic that affects Sweden and the rest of the world has a major impact on all parts of society and has had far-reaching effects on businesses around the world. AroCell is affected to a relatively limited extent. The internal operations continue to be uninterruptedly driven forward and important steps are taken for preparation for continued dialogue with the FDA. Some meetings and conferences have been cancelled or postponed, which means that we are reviewing our plan for publishing clinical data. Otherwise, Corona pandemic impact on AroCell is limited. The value of the company is based, among other things, on future sales and how AroCell in the future can contribute to better care for cancer patients. AroCell continues to work with the goal of getting our AroCell TK 210 ELISA approved by the FDA in the United States by 2021. Until then, we will have limited sales on the U.S. market.

"As a company, our share price is highly effected by what is happening in the stock market right now but if we look at fundamentals we are hardly affected at all. We have digital meetings that replace physical meetings and continue our business of developing collaborations and contacts with oncologists", says Michael Brobjer, AroCells CEO.

The following members have been identified as the three largest shareholders that are willing to participate in the Nomination Committee and they have appointed the following members:

• Mikael Lönn, represents his own shares

• Bernhard Tribukait, represents his own shares

• Jon Eiken, represents his own shares

• Claes Post, Chairman of AroCell AB

In total, the Nomination Committee represents approximately 10% of the total number of shares and votes in the company.

The Nomination Committee elected Jon Eiken as chairman.

The Committee’s proposal will be presented in Notice of Annual General Meeting 2020 that will be held in Uppsala the 6 of May 2020 as well as on the company ́s webpage, www.arocell.com. Shareholders that wish to leave suggestions to the Nomination Committee can do so by sending an email to info@arocell.com (header: AroCell ́s Nomination Committee) or via regular mail to

AroCell AB
Att: Valberedning
Virdings allé 32B
754 50 UPPSALA

The poster is entitled “Serum Thymidine Kinase 1 levels predict prostate cancer-specific survival” and is based on a study by Teemu Murtola of Tampere University Hospital. In the study the samples from two groups of men were used; one with localized prostate cancer and another with metastatic disease at diagnosis. Serum Thymidine kinase 1 (TK1) protein levels at the time of diagnosis were measured with AroCell TK210 ELISA and compared with the extent and speed of disease progression over a period of 10 years.

The abstract of the study will be published online on the AACR website on Tuesday, March 24, 2020, and the poster will be presented on Monday, April 27.

Marianne has over 20 years’ experience of international business development and sales in Life science and has a broad knowledge in the global pharma and diagnostic market. She has also documented experience in direct sales and very good experience in building strong relationships with both established and new distributors.

Marianne has previously worked at Karo Pharma and Mercodia. During her time at KaroBio (now Karo Pharma), Marianne developed her business development skills by working with out-licensing. At Mercodia, Marianne was "Global Export Manager" and was responsible for sales of ELISA kits through distributors globally. Marianne’s most recent employment was at Calmark Sweden AB.

"I’m looking forward to start working at Arocell in this interesting phase that the company is in," says Marianne Alksnis. "It will be exciting to contribute with my knowledge and experience in building a global company".

"I am very pleased that Marianne has chosen to start working at Arocell. Marianne has a long international experience in sales and will focus on increasing our sales and continue to develop and build up our distributor network in our various markets," says Michael Brobjer, CEO of AroCell. "With Marianne, we have now recruited three key positions who together strengthen AroCell's ability to achieve success. With these reinforcements in Regulatory, Clinical development and Sales, AroCell stands significantly stronger for future challenges," concludes Michael Brobjer.

The article is entitled “AroCell TK 210 ELISA for determination of TK1 protein: Age-related reference ranges and comparison with other TK1 assays”, by Kiran Jagarlamudi et al. The aim of the study is to establish the age-related reference ranges of TK1 protein levels in sera from apparently healthy individuals (N=264), and comparison of AroCell TK 210 ELISA with Abcam TK1 ELISA using sera from patients with hematological malignancies (N=62) as well as solid tumours (N=30).

The results of this scientific study demonstrated that the AroCell TK 210 ELISA has higher sensitivity than the Abcam TK1 ELISA for differentiating hematological malignancies and solid tumors from apparently healthy individuals. These results strongly indicate that the AroCell TK210 ELISA is accurate and sensitive enough to be a valuable tool in cancer management compared to other TK1 assays.

“We are delighted with the results of this scientific study, which demonstrate that the AroCell TK 210 ELISA kit has high accuracy and sensitivity compare to other methods”, Michael Brobjer CEO at AroCell.

The publication will soon be available on biotechniques.com and on arocell.com.

The abstract is entitled “Evaluation of TK1 protein changes using the AroCell TK 210 ELISA in an acute myeloid leukemia (AML) xenograft model during 5-fluoruracil treatment.” by Jagarlamudi KK. The study describes the utility of TK1 protein levels by AroCell TK 210 ELISA to monitor the changes in AML xenograft mouse model during 5-fluorouracil treatment.

The abstract will be online on the AACR Online Itinerary on Tuesday, March 24, 2020.

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.

Cecilia Ahlin has over 20 years of experience treating cancer patients and has a PhD in prognostic factors in breast cancer. She became a specialist in general oncology in 2003 and in gynecological oncology in 2011. She has experience from the Swedish MPA as clinical assessor and most recently from Novartis where she was Medical Head Oncology Sweden. Cecilia holds an associate professorship in Oncology at Örebro University.

“I’m very glad that we are able to attract such an experienced oncologist to our management team. Cecilia will contribute with her deep knowledge and insights of praxis in breast cancer treatment and in other tumors. She will be responsible for our clinical strategy with focus on getting more clinical evidence for using AroCell TK 210 ELISA in clinical settings.”, says Michael Brobjer, CEO at AroCell. “Cecilia’s long clinical experience and the fact that she still is an active oncologist treating patients, gives me the confidence that AroCell will deliver assays suitable for clinical use.”

“I look forward to working with AroCell in the role of CMO and to make AroCell TK 210 ELISA standard of care for the treatment of cancer patients. Together with the management team, I will continue to strengthen AroCell’s clinical research program and our collaborations with external stakeholders. The target is to generate additional data on Thymidine Kinase 1 (TK1) both as a prognostic/predictive biomarker as well as a response biomarker for personalized oncology.” says Cecilia Ahlin.

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.

In the study TK1 protein levels will be assayed in serum samples collected from subjects with liver cancer, Hepatocarcinoma, prior to and during therapy and compared with the extent and speed of disease progression based on digital imaging. Hepatocarcinoma is the 5th commonest form of cancer, with around 800 000 cases diagnosed in 2012, and the incidence is increasing.

The response rate to therapy in advanced cancer is very low, only 2-5%, but there is potential to improve on this by using more personalized therapy. The combination of digital imaging with circulating biomarkers (Radiomics) can aid in identifying early therapeutic response, relapse and monitoring subsequent therapy. TK1 may be particularly important here as it may provide an indication of the rate of cellular proliferation in the tumour.

The study will be executed in collaboration with the Professor Ferruccio Bonino at the Institute of Biostructure and Bioimaging, National Research Council, Italy.

“We are excited to work together with Professor Bonino”, says Michael Brobjer, CEO of AroCell. “His innovative approach to combining biomarker modalities could improve the outcome of patients with a significant disease”.

Professor Bonino commented “We are very happy to cooperate with AroCell in this exciting project. The combination of a biomarker of cell proliferation (TK1) with digital imaging could provide important information on the aggressivity of the tumour and a new parameter of therapy response.”

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 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 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 and relapse in subjects with hematological and solid tumors.

About IBB-CNR
The Institute of Biostructures and Bioimaging (IBB) of the National Research Council (CNR) has 100 employees distributed in Naples, Catania and Turin (70 researchers / technologists) and carries out translational research for the development of new tools for prevention, diagnosis and targeted therapies. Researchers studying biomolecules from a structural and functional point of view collaborate with experts in preclinical imaging, who study cellular and animal models of human diseases and with researchers performing clinical trials in humans.