AroCell AB ja TK1-testi

TIEDONANTO AROCELL AB:N (PUBL) VARSINAISESTA YHTIÖKOKOUKSISTA 24.5.2022

24.5.2022 11.00 • MFN •

Kopioi linkki leikepöydälle

AroCell AB (publ) (“Yhtiö”) on pitänyt varsinaisen yhtiökokouksensa tänään 24.5.2022. Varsinainen yhtiökokous päätti kaikkien hallituksen ja nimitysvaliokunnan tekemien ehdotusten mukaisesti. Kokous toimitettiin postiäänestyksellä ilman fyysistä osallistumista.

Taseiden ja tuloslaskelmien hyväksyminen

Varsinainen yhtiökokous vahvisti yhtiön taseen ja tuloslaskelman tilikaudelta 2021.

hallitus

Varsinainen yhtiökokous myönsi toimitusjohtajalle ja hallitukselle vastuuvapauden vuoden 2021 hallinnosta.

Varsinainen yhtiökokous päätti valita seuraavan varsinaisen yhtiökokouksen päättymiseen saakka hallituksen jäseniksi uudelleenvalintamenettelyllä Eva Nordströmin, Charlotta Ljungqvistin ja Max Pihlqvistin sekä hallituksen jäseniksi Agneta Tufvesson Almin ja Johan Häggbladin kautta. uudet vaalit.

Hallituksen puheenjohtajaksi valittiin Johan Häggblad.

Hallituspalkkiot

Varsinainen yhtiökokous päätti, että hallituksen palkkio seuraavaan varsinaiseen yhtiökokoukseen saakka on puheenjohtajalle 250 000 kruunua ja muille hallituksen jäsenille 150 000 kruunua.

Kirjanpitäjä

Lisäksi yhtiökokous päätti valita uudelleen tilintarkastusyhteisöksi Öhrlings PricewaterhouseCoopers AB:n päävastuullisena tilintarkastajana KHT Leonard Daun seuraavan varsinaisen yhtiökokouksen päättymiseen saakka.

Päätös, jolla hallitus valtuutettiin päättämään uudesta osakeannista, joissa on etuoikeutettu tai ilman yhtiön osakkeenomistajia

Yhtiökokous päätti esitetyn ehdotuksen mukaisesti valtuuttaa hallituksen yhden tai useamman kerran ennen seuraavaa varsinaista yhtiökokousta päättämään osakkeenomistajien etuoikeudesta poiketen tai osakkeenomistajien etuoikeudesta poiketen uudesta osakeannista tai vaihtovelkakirjalainojen tai warranttien liikkeeseenlasku.

Tämän valtuutuksen perusteella annettavien osakkeiden, vaihtovelkakirjojen tai optioiden lukumäärää annettaessa osakkeenomistajille ilman etuoikeutta on rajoitettava siten, että osakkeiden lukumäärä kokonaan merkityn uuden annin, optio-oikeuksien täyden käytön tai täyden muuntamisen jälkeen , ei nouse enempää kuin 20 prosenttia tämän ilmoituksen ajankohtana ulkona olevista osakkeista.

Päätös yhtiöjärjestyksen muuttamisesta

Varsinainen yhtiökokous päätti vahvistaa uuden yhtiöjärjestyksen. Muutetaan yhtiöjärjestyksen 3 momentti seuraavasti:

“Yhtiö harjoittaa suoraan tai välillisesti tytäryhtiöiden tai muiden osakkuusyhtiöiden kautta tutkimus-, kehitys- ja valmistustyötä sekä tuotteiden ja palveluiden kauppaa ja myyntiä solubiologian, lääketieteellisen teknologian ja diagnostiikan sekä tähän yhteensopivaan toimintaan.”

Täydelliset ehdotukset ja päätökset

Tarkempia tietoja päätösten sisällöstä saat kokonaisuudessaan osoitteesta

ylimääräinen yhtiökokous. Kutsu varsinaiseen yhtiökokoukseen ja täydelliset ehdotukset ovat saatavilla osoitteessa

Yrityksen kotisivut http://www.arocell.com

Yhteystiedot

Anders Hultman, toimitusjohtaja

Puhelin: +46 (0) 18 50 30 20

Sähköposti: anders.hultman@arocell.com

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Årsstämman beslutade att styrelsearvode för tiden intill nästa årsstämma ska utgå med 250 000 SEK till ordföranden och att styrelsearvode till övriga styrelseledamöter ska utgå med 150 000 SEK.

Tuossa on kyllä aika nasty epäsuhta, kun firman tulos oli -50 MSEK :smiley:

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Ei tuo palkkio pätevästä henkilöstä ole euroiksi muutettuna mikään kovin iso, aika tietysti näyttää onko se kuinka oikea.

Itse maksaisin pätevälle henkilölle kunnon korvauksen, kuin että alettaisiin säästämään tärkeimpien henkilöiden palkkioista.

Pätevimmät on saatava, harvoin ne on halvimmat. Olisin huolissani jos tekisivät talkoilla.

Tietysti palkkiosta osa olisi voitu antaa osakkeina

Published today, by AroCell.

- We are very happy to have acquired IDL Biotech’s expertise. Thanks to their solid knowledge of rapid tests and our expertise in TK1, we have together moved five years forward in development, says Anders Hultman. (translation by google)

…we have together moved five years forward in development…

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Biovica - Capital Market day 2022.

Two hours, but very interesting. Filing of a new patent application for DiviTum among other things.

But there seems to be quite a heavy logistic side of the coming US operations for Biovica, including a new specific blood draw procedure that needs to be FDA cleared, and also 24 hour transportation of all blood tests through USA to Biovicas CLIA lab in San Diego, where all analytical testing will be done?

Perhaps will AroCell approach the US market in a different way? Apparently, point of care testing at the doctors office (as probably will be the case, at least for UBD Rapid) will not require an additional parallell analytical service apparatus facilitated by AroCell somewhere in the USA?

And regarding TK210 ELISA, this technology may easily be automated by Roche or some other big player… so in AroCells case future TK1 testing may very well be facilitated in bigger scale directly on large hospitals through automated platforms?

In Biovicas case I am not sure about this apparently, as I understand, rather big additional in house analytical apparatus that needs to be in place to accomplish all this and make it work practically?

Point of care testing at doctors office, on the other hand, will probably be very easy and work very well, whithout practical complications, once FDA cleared. And if Roche decides to run TK1 in bigger scale on an automated platform, cobas, this will also be very easy for AroCell to handle practically.

On the other hand, if Biovica succeeds, than AroCell may have the opportunity to follow this model in a similar way, if so desirable?

Anyway, very interesting to follow both companies, and I wish both companies will succeed, and that both companies will be able to help each other through the overall implementation of TK1 in clinical practice.

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Suhteellisen pienellä vaihdolla kurssia saadaan heilutettua.

Ilmeisesti mitään uutista ei kuitenkaan ole tullut mistä johtuu.

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Rhovac fails in phase2, but Rhovac CEO Anders Månsson says that now the company will continue analyzing the obtained phase2-data, and it cant be ruled out that they perhaps will find a biomarker that may be relevant in some subgroup, says Rhovac CEO.

Well, as an AroCell shareholder I propose that this may now be a relevant opportunity suggesting Rhovac to analyze if the AroCell biomarker serum TK1-concentration can add value to the Rhovac case! :wink:

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Some interesting TK1-results from Alertix, first published online earlier this spring, that may perhaps deserve some attention. The study shows that combining serum TK1 protein measurements with CRP (a standard biomarker of inflammation) can add clinical value in hematological malignanies.

The Alertix study is performed in dogs, and the combination of CRP and TK1 is referred to as the Neoplasia Index (NI). Some quotes from the article (authors are Staffan Eriksson, Kiran Kumar Jagarlamudi, Liya Wang and the Alertix research team):

”The association between tumor development and inflammation plays an important role in tumor cell survival. Among the most commonly used inflammatory markers in routine diagnostics is C-reactive protein (CRP).” /…/

”In this article, we have shown that adding CRP-levels to the cell proliferation marker TK1 indicates that the utility of a combination improves the clinical value.” /…/

”There are many similarities between canine lymphoma and human non-Hodgkin’s lymphoma (NHL) such as clinical presentation, molecular biology, treatment, and treatment response. This makes canine lymphoma in client-owned dogs with spontaneous occurring disease a valuable comparative model for human NHL.” /…/ (canine = dog)

”This study shows that CRP level can be a valuable complement to TK1a and TK1p levels in monitoring dogs with hematologic malignancies during treatment and can also help in prognostication.”

Source (Research in Veterinary Science, Volume 145, July 2022):

As cancer diagnostics in dogs and humans share many similarities, these results may be quite interesting. A speculation could be that if a standard biomarker like CRP can add clear and easy value to TK1, then maybe such positive results could help lowering the threshold for a bigger player, maybe Roche, to step in.

As clinical decision making based on serum TK measurements is already, since many years, established within hematological malignancies, this may perhaps be a possible “first area of application” if AroCells TK1 technology is to be implemented in bigger scale on automated platforms.

Who knows… but, as an amateur, I would like to speculate that such confirmed utility of the Neoplasia Index, through CRP in combination with serum TK1 protein measurements, is a positive step in the right direction.

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Interview Anders Hultman.

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https://arocell.com/mfn_news/

AroCell announces today that their quantitative point-of-care (POC) oncology product UBC® Rapid has been verified for results interpretation on a new instrument, the Cube Reader. By differentiating UBC® Rapid and addressing the different needs of end-users, the possibility of a more widespread use increases.

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New Chief Scientific Officer (CSO), Maria Hägg Olofsson

Maria has worked at VLV Bio (Nacka, Stockholm) and, as I understand, there are some specific antibodies (ex M30, M65) from VLV Bio targeting cytokeratins that is used by AroCells US partner Diapharma Group.

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Nothing but a timely coincidence of course, but it seems as if Diapharma just a few days ago provided a Youtube update on VLVBios M30 and M65 antibodies targeting cytokeratins. Presenter is Olivia Stricker, who also did the presentation on AroCells TK210 back in 2020.

Source (Diapharma update on the Peviva antibodies from VLVBio - posted on Youtube, 16 June 2022):

The antibodies from VLVBio is of course not identical to IDL Biotechs cytokeratin product line… but anyway, nice to hear Olivia Strickers enthusiasm - maybe referring also to cytokeratin 18 in general?

It will be interesting to see what positives AroCells coming combination product, cytokeratin + TK1, can bring to the table.
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Reference (Olivia Stricker talk on TK1 and in combination with cytokeratin, from 2020):

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Apparently, according to the following abstract from recent ASCO 2022, UBC Rapid has been part of some kind of pilot study in connection with bladder cancer.

Title: “Association of FGFR alterations with FGFR 1-4 gene expression in TUR biopsies and matched NMP22 urine levels in early bladder cancer of the prospective real world clinico-pathological register trial: BRIDGister.” /…/

“In addition urine samples were analyzed by commercially available urine tests (UBC Rapid, BTA stat, NMP22).”

https://meetings.asco.org/abstracts-presentations/197855

A small pilot study, and there are also several other detection methods participating in the study.
But the fact that Thorsten Ecke is one of the investigators, and also that the abstract is published at ASCO 2022, may be of some general interest.

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This is a speculation, but maybe is the following the original patent covering the unique M30 antibody
that recognize caspase cleaved cytokeratin 18? The M30 antibody is probably important as it enables to distinguish between two different modes of cell death - necrosis and apoptosis.

From the patenttext:

"During research work aiming at finding new useful specific monoclonal antibodies reacting with human cytokeratin 18 (CK 18), in addition to those already at hand, it was surprisingly found that a monoclonal antibody (MAb) (obtained after immunization of mice with a specified part of the amino-acid sequence of CK 18) recognized early apoptotic changes in cultured epithelial cells. This MAb was designated M30."

Source (this may be the original patent, covering the M30 antibody??):

The patent is assigned to Vivalavida AB… and this is probably synonymous to… VLVbio!

Of interest may be that this original M30 patent actually seems to have expired in 2018! I have so far not found any later complementary M30 patent… and if this holds true… than the patent landscape may perhaps allow AroCell to pick up the unique features of the M30 antibody, and develop an alternative “AroCell-version” of the M30??

And Maria Hägg Olofsson may very well have special knowledge about significant features of the VLVbio product line, including the M30 antibody?

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For reference - the following work from 2007, in which Maria Hägg Olofsson is one of the authors, is interesting as it delivers further understanding on cytokeratin 18, including the caspase cleaved CK18 (M30 antibody) in the monitoring of cancer disease.

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A short demo from the Philippines, on the hands-on handling of the TUBEX kit. Seems to be posted today, 21 June. Immunologic Assay fr Typhoid Fever: Tubex - YouTube

DMSFI, who posted the demo, appears to be one of the top-quality centers in the Phillippines.

“DAVAO MEDICAL SCHOOL FOUNDATION INC has the main aim to provide quality medical education and training so that the medicinal solutions may grow in both the rural and urban parts of the country.” https://www.dmsf.net/

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The following study seems to show some of the benefits that perhaps are to expect from coming future combination assays providing measurements of both cytokeratins and TK1. This study from 2016 is an example in gastrointestinal cancer, and appears to show clear benefits using the combination strategy:

"The results indicate that positive CK19 expression predicts poor OS in patients with advanced gastrointestinal cancer; however, that patients who are positive for CK19 but negative for TK1 might have a better prognosis. In other words, patients who are positive for both CK19 and TK1 expression have worse OS than those who are positive for CK19 but negative for TK1 expression in advanced gastrointestinal cancer.

In conclusion, co-expression of CK19 and TK1 might be crucial for the progression of tumors and, therefore, for the prognosis of patients with gastrointestinal cancer, indicating that the expression of these might be considered as independent prognostic markers."

It would be really nice if such positive results also will be applicable to, for example, breast and prostate.

This is only an amateurish speculation, but maybe the combination strategy could also help to clarify the biological origin of sTK1 in some situations, such as in some cases with low, but changing sTK1?
That is, as the cytokeratin level indicates epithelial cell death… this level would therefore, if high, indicate that the release of sTK1 probably also has the origin in these disintegrating epithelial cells?

And - vice verca - as cytokeratins are only released from epithelial cells, not from cells active in the immune system… a low cytokeratin level could therefore indicate that a rising level of sTK1 may instead have the origin in a reaction in cells of the immune system?

Maybe that is still a relevant question, regarding the origin of serum TK1, in the low level spectrum?
To be able to even more clearly define the biological landscape that result in changing levels of sTK1, in the low to normal level setting, in some situations?

Only irrelevant amateurish speculations, of course… coming clinical studies will tell the facts.

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Biovica delivered an interesting presentation at Pareto a few days ago, and in the link below are the slides from the presentation.

From a fundamental view, looking at TK1 versus ctDNA, it may appear quite promising to see that TKa actually performed better than ctDNA in stratifying patients in the BioItaLEE Study!

Source (TKa vs ctDNA; slide 15):

Biovica is doing a great job in establishing credibility and clinical evidence on TK1. The AroCell version of TK1 technology may have some technical advantages, like easier to automate and, as an immunoassay, easier to implement in panels in combination with other biomarkers, (edit) and access to a growing point-of-care segment is also an opportunity through the AroCell TK210 technology. In addition TK-activity and TK1-protein deliver somewhat slightly complementary TK1 information - with TK1-protein maybe regarded as more sensitive in earlier stages of disease. (edit) While the sensitivity of the assays may differ between cancer indications - for example in the case of prostate cancer it seems as if AroCell TK protein may deliver more competent results - it has also been proposed that a combination index (the ratio between sTKa and sTKp) could be beneficial in some situations.

In my amateur-view it would be really interesting if the two companies could reach consensus on future long term cooperation, which would result in a super-TK1-company capable of delivering all relevant aspects of expanded TK1-diagnostics, regardless of any costumer needs. And in addition, AroCell is now capable of adding IDLs powerful cytokeratins into the equation.

And a hypothetique positive PM on the Roche-deal could, of course, change everything for AroCell. The Roche-deal was signed in 2018, and the then-CEO, Jan Stålemark, informed that 3-4 years may be an adequate timeframe before inplementation (3-4 years also seems applicable when looking historically on other Roche-implementations, like HE4).

Another circumstance that perhaps may be noticeable, pointing at 2022, is that the Diasorin patent on the LIAISON TKa-assay expires late july 2022. This may perhaps (??) put up a new situation, in which Roche perhaps will have a natural opportunity to change direction in the TK1 landscape?? (amateur speculation)

If Roche decides on implementing the 210-technology (AroCells technology), perhaps with a start within blood malignancies… than, as serumTK is so far not FDA-cleared, the whole of the US-market would be a new possible market opportunity for the Roche-assay within blood malignancies (Diasorins LIAISON-assay is not FDA-cleared).

An amateur speculation could be that… perhaps, just perhaps… maybe a DiviTum TKa FDA-clearence for Biovica, would serve as the USA TK-clearence needed by Roche?? That is… maybe what Roche wants is any USA TK-clearence, which would than serve as a predicate device for a new Roche TK-cobas-assay?

On the other hand, there are still patent issues that seems to be not fully resolved yet - allthough the “patent-questions” are extremely complicated and therefore impossible to judge at all. It may very well turn out that the patent landscape between Roche/AroCell is fully satisfactory solved, and that the remaining issues are, practically speaking, irrelevant on the Roche/AroCell-deal - who knows? Impossible to judge of course, as being an amateur.

All in all, having followed the Roche-deal since 2018, one could speculate that 2022 have some potential to maybe be an interesting year.

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What a joke - the information from Avanza says that the Avanza-Placera Stock Forum is “temporary” down. The facts are that the Avanza Stock Forum now has been down for more than six months.

https://www.avanza.se/placera/forum.plc.html

And the Roche TK1-patent application process has also not delivered any progress at all in more than a whole year.

What are these people doing all this time ?? In the Roche case there seems to be enough delay to be able to pass higher university education on the subject at hand…

And the new AroCell / IDL website…?? The merger took place a year ago… just wait, wait… and more wait… and in between cash out another some million swedish buckes in financing everything…

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Tämä on niin arpapeliä Arocellin kanssa, mutta, toinen neljännes on nyt käyty ja elokuussa kuullaan miten on kehittynyt tai ei ole.

Potentiaali on suuri ja vaikeaa on saada sitä hyödynnettyä, ehkä 1/100 yrityksistä sen pystyy hyödyntämään. Jos sekään.

Kaikki viittaa kuitenkin siihen että jokin plaani on ja yrityskauppoja on tehty, antiin on osallistunut muutkin kuin piensijoittaja, pienellä vaihdolla kurssia on poljettu, eli se ei kerro yrityksen laadusta, vaan sijoittajien. TJ on ostanut osakkeita, joka kertoo minulle, että luottaa yritykseen ja itseensä. Maailman tilanne tietenkin rasittaa kaikkea sijoittamista ja pahimmillaan elämää.

Hyvä kuitenkin että ei yhtiö lähde yrittämään nostattaa kurssia, vaan luottaa ja keskittyy kannattavaan liiketoimintaan.