Biocartis BE0974281132

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1. ElTorro 21 december 2021 08:52

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   "Given the rapidity, full automation, and practical advantages of the Idylla SARS-CoV-2 assay, pooling of 10 samples has the potential to significantly increase testing capacity for both NPS and saliva samples, with good sensitivity."
2. Dr Zoot 21 december 2021 16:56

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   If ArgenX can serve as an example, their recent FDA approval for Efgartigimod generated a +/-13% SP gain. Applying the same logic to Biocartis' long-awaited FDA approval, we can hardly expect a SP of 4€. I know both are not comparable, but nevertheless not really comforting :-(
3. ElTorro 21 december 2021 20:33

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   The main reason why the share is being pulled down, is because a great amount is being shorted.
   This has also a lot to do with the convertibles that are still standing till 2024.
   Only a massive increase in sales and production can turn this around. That is why we were looking forward towards the 60% growth that was promised this year, strong growth that is necessary to become profitable. What can they deliver and also what is the next step to keep the car running.
   
4. Dr Zoot 23 december 2021 17:18

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   Looking at the short positions published by FSMA, I see only 2 positions: Citadel EU 1% unchanged since 18/12/2020 and Millenium Capital Partners 0.60% since 25/05/2021. At that time Biocartis SP was still at 3.90 -4.00€. What can bring the SP back to 4.50 let alone 5.00€ mark? FDA approval (last time one test was approved, all SP gains disappeared in less than 3 days). More sales? Sure, always helpfull. New tests on the platform ? I feel Rudi Pauwels was paying much more attentioan at PR around achievements, no matter how big or how small. Now, events come and go, nobody notices, which is letal for a small cap like Biocartis.
5. 21nov 23 december 2021 18:06

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   De Shortpositie op 23 december 2021 is 3,13%. 2,53% voor rekening van Citadel Europe en 0,60% voor rekening van Millenium International Management.
6. 21nov 23 december 2021 20:52

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   Gaan we weer zakken naar €3,00 (17/03/2020) ? om dan in iets meer dan een maand door te stijgen naar €5,60 (24/03/2020). Het zou mooie zijn. Dr Zoot Uw bemerking "Nu komen en gaan gebeurtenissen, niemand merkt het, wat dodelijk is voor een smallcap als Biocartis" is terecht maar toch zijn er uitzonderingen. Neem nu in smallcap "Greenyard" eveneens door zeer zware stormen moet gaan maar er vandaag toch staat. Greenyard betaalde op 22 december 2021 zijn converteerbare obligatie lening van €125.000.000 terug. Een schuldeninstrument met een rente van 3,75%. De converteerbare obligatie van Biocartis vervaldatum 2024 is een schuldeninstrument met een rente van 4%. Het is dan ook zeer moeilijk te voorspellen welke richting het zal uitgaan maar tot op vandaag en dit al drie jaar lang is de richting naar beneden .
7. OzDx 24 december 2021 06:55

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   Brand new article discussing use of Idylla as a screening test before NGS
   
   Contribution of the IdyllaTM System to Improving the Therapeutic Care of Patients with NSCLC through Early Screening of EGFR Mutations
   
   Abstract: Epidermal growth factor receptor (EGFR) genotyping, a critical examen for the treatment
   decisions of patients with non-small cell lung cancer (NSCLC), is commonly assayed by next-generation sequencing (NGS), but this global approach takes time. To determine whether rapid
   EGFR genotyping tests by the IdyllaTM system guides earlier therapy decisions, EGFR mutations
   were assayed by both the IdyllaTM system and NGS in 223 patients with NSCLC in a bicentric
   prospective study. IdyllaTM demonstrated agreement with the NGS method in 187/194 cases (96.4%) and recovered 20 of the 26 (77%) EGFR mutations detected using NGS. Regarding the seven missed EGFR mutations, five were not detected by the IdyllaTM system, one was assayed in a sample with insufficient tumoral cells, and the last was in a sample not validated by the IdyllaTM system (a bone metastasis). IdyllaTM did not detect any false positives. The average time between eGFR genotyping results from IdyllaTM and the NGS method was 9.2 ± 2.2 working days (wd) (12.6 ± 4.0 calendar days (cd)). Subsequently, based on the IdyllaTM method, the timeframe from tumor sampling to the initiation of EGFR-TKI was 7.7 ± 1.2 wd (11.4 ± 3.1 cd), while it was 20.3 ± 6.7 wd (27.2 ± 8.3 cd) with the NGS method (p < 0.001). We thus demonstrated here that the IdyllaTM system contributes to improving the therapeutic care of patients with NSCLC by the early screening of EGFR mutations.
   
   --------------------
   Tumor sampling to initiation of EGFR-TKIs was reduced by two weeks when the decision was based on the IdyllaTM method compared to when the decision was based on the NGS method.
   
   This has always been my investment thesis for Biocartis.. One day it'll be standard way of testing imo.
8. Thole 24 december 2021 08:26

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   So once more promising news.
9. Flatlander 24 december 2021 16:53

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   Oz
   This statement appears to be erroneous/
   
   "The average time between eGFR genotyping results from IdyllaTM and the NGS method was 9.2 ± 2.2 working days (wd) (12.6 ± 4.0 calendar days (cd)). Subsequently, based on the IdyllaTM method, the timeframe from tumor sampling to the initiation of EGFR-TKI was 7.7 ± 1.2 wd (11.4 ± 3.1 cd), while it was 20.3 ± 6.7 wd (27.2 ± 8.3 cd) with the NGS method (p < 0.001). "
   
   How can the ave time to treatment be 7.7 days using Idylla when the ave turnaround of results is 9.2 days? The statement says a lot about the bureaucracy of these facilities. We all know Idylla provides results in hours not a week. Considerable time is lost in the way Idylla is being used (i.e, interfacing between the lab technician and the oncologist). This can be improved by moving idylla closer to the oncologist.
   
   Finally the fact that Idylla recovered only 20 of the 26 (77%) EGFR mutations detected using NGS is concerning. We know from the paper released earlier this year that most if not all of this discrepancy is due to missed T790M mutations. Unfortunately, this is one of the most common NSCLC mutations and is critical for for prescribing Tagrisso, one of the best selling treatment drugs (and one of the largest products of our partner AZN). The technical articles I read indicate the problem is an incorrect amplification curve for this mutation. It is correctable and I've discussed it with Renate a year ago. This problem was to be resolved in the BRAF-EGFR assay that was supposed to be released this year. Well they kicked the release of this assay back to 2022. Perhaps they are using the constrained product release after the fire as an opportunity to clear the market of the Old EGFR test before launching the new one.
   
   This is my growing frustration w Biocartis, They do not act with any urgency. They double the headcount but they are no better at R&D then they were 4 years ago. The analyst community in Belgium really does not apply pressure to get answers.
   
   I still think there is a large market for automating MDx but BCART needs to demonstrate that they can execute in delivering on the promise of Idylla.
   
   FL
10. OzDx 24 december 2021 23:30

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    Merry Christmas FL,
    
    The analysis time includes tumor sampling to histological analysis which takes 5.3 +- 3.6 working days and then it's egfr request (decision making) to actual analysis on the Idylla which takes 1.5 +- 1.3 working days as opposed to 10.3 +- 2 working days when it's NGS.
    
    The study is taking a holistic approach. As tumor samples are precious samples, there'll be extra steps ensuring right test is ordered etc...
    
    Hope we'll see a turnaround story for Biocartis in 2022!
11. Flatlander 27 december 2021 15:24

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    quote:

    OzDx schreef op 24 december 2021 23:30:

    Merry Christmas FL,
    
    The analysis time includes tumor sampling to histological analysis which takes 5.3 +- 3.6 working days and then it's egfr request (decision making) to actual analysis on the Idylla which takes 1.5 +- 1.3 working days as opposed to 10.3 +- 2 working days when it's NGS.
    
    The study is taking a holistic approach. As tumor samples are precious samples, there'll be extra steps ensuring right test is ordered etc...
    
    Hope we'll see a turnaround story for Biocartis in 2022!
    

    Oz
    Thanks for the explanation, I know that sample volume is a huge issue. I've read a couple articles about protocols for using the cytology smear samples after deinking. If this procedure can be refined it would make it easier to incorporate Idylla into a labs workflow. The other point I always like to see emphasized in these studies is that Idylla has typically been able to return actionable results for many samples that did not have sufficient suitable DNA for NGS analysis. The MSK study emphasized this as an important feature of Idylla.
    
    I hate to keep harping on the mutation amplification issue but it has to be of extreme importance to our largest pharma partner and given the higher EGFR mutation prevalence in Asian populations, I believe it is critical before launching in China and Japan.
    
    I also hope for a turnaround in 2022. I keep saying that I think BCART is flying way below the radar of most MDx investors and has the potential for the stars finally aligning to get critical registration approvals at the same time the world emerges from the pandemic (or at least when it becomes endemic).
    
    Regards to you,
    Best wishes for a great 2022!
    FL
12. ElTorro 27 december 2021 17:23

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    Hey all, before leaving on a break I would also like to thank you guys for all the informative, critical and objective insights.
    Let's stay positive on the future of this company, which has a huge potential, if this and that.. :-)
    All the best for 2022, and most importantly stay healthy.
13. Flatlander 28 december 2021 14:29

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    ElTorro
    Enjoy the break. Have a happy New Year!
    
    FL
    
14. Flatlander 29 december 2021 00:58

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    An interview with ImmunExpress' CEO.
    www.dnaweekly.com/blog/immunexpress-i...
    
    A couple things jump out:
    
    1) They are planning on rollout of Septicyte Rapid in 2022 (i.e., it did not initiate it upon FDA approval in November). The time lag may be related to the reagent shortage we have discussed on the board. Presumably they are now building inventory in the US in anticipation of the rollout.
    
    2) The ImmunExpress rollout is constrained by funding availability. Diapharm was/is an early investor. They made a cash infusion about 2 years ago to fund the development of Septicyte Rapid, I'm surprised an additional round of funding has not been announced.
    
    3)They are already working on the next generation Septicyte Rapid.
    
    FL
    
    
15. Bonsjoer 3 januari 2022 15:08

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    Andere jaren werd er begin januari middels een persbericht bekendgemaakt of de jaardoelstelling behaald is., incl de daadwerkelijke verkoop cijfers. Gaat er dit jaar ook zo'n persbericht komen ?, voorgaande jaren meestal rond 10/11 januari, op de site/agenda van Biocartis kan ik er niks over vinden.
16. Thole 3 januari 2022 15:37

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    Hopelijk doen ze dit inderdaad opnieuw. Zou ons al een goed idee geven van hoe ze hersteld zijn van de brand en hoe groot de eventuele problemen met grondstoffen zijn.
17. Flatlander 3 januari 2022 18:14

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    chicago.cbslocal.com/2021/12/28/chica...
    
    This is why I've said that this is a good environment for BCART (assuming that BCART can secure a raw reagent supply). All of those PCR tests are likely to overwelm some labs. Idylla's shelf stable, on demand use profile, with little hands on technician time is ideal for this environment. Especially as oncology testing picks up.
    
    So any opinions of whether this is the year that management finally starts delivering on expectations? I consider this a pivotal year and will I'll be re-evaluating management performance throughout the next 12 months. If they cannot show substantial progress with the current tailwinds, it will be time to throw in the towel. Here is a short list of milestones I'd like to see in 2022:
    
    1)Release of the revamped EGFR assay that resolves the T790 mutation issue. This is likely to be in the Braf-EGFR combo assay;
    2) FDA approval of the MSI 510K and launch (non RUO) in the US;
    4) SkylineDx initiating validation of the Merlin Assay for nodal metastasis in melanoma. Note this program seems to be on an accelerated timeline since Skyline is incharge of the R&D associated with developing the assay;
    3) Successful launch of Septicyte rapid in the US;
    4) Announcement of ML3 completion and start up testing, and news that it was accomplished under budget;
    5) China registration approval for the 3 assays that were filed (MSI, Braf & EGFR) & announcement of BMS launch support for the MSI assay;
    6) Japan registration approval news;
    7) News that a reliable reagent sourcing has been secured;
    8) News of a funding plan with limited dilution impacts. Perhaps that Cathy wood's Ark funds have established positions in BCART (Additional shares were authorized at the last A.M). She brings quite a Reddit following that would create upward pressure on the SP;
    9) News of Kite or other partner validation testing news;
    www.thestreet.com/investing/cathie-wo...
    
    Okay so I slipped a wishful item along with some of the more realistic milestones.
    Happy New Year!
    FL
18. CGCDLR 3 januari 2022 19:53

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    Thanks,FL,a happy new year.
19. Flatlander 4 januari 2022 21:40

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    Immunexpress is providing an update on Septicyte Rapid commercialization plans (See below).
    FL
    
    Immunexpress CEO To Present at the Virtual Biotech Showcase 2022
    
    SEATTLE, Jan. 4, 2022 /PRNewswire/ -- Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today that Chief Executive Officer, Rolland Carlson, Ph.D., to present a corporate update, accessible on demand, at the virtual Biotech Showcase 2022 to be held Jan. 10-12 and Jan. 17–19, 2022.
    
    Dr. Carlson will present an overview of Immunexpress' SeptiCyte® technology and a corporate update on commercial plans for newly FDA cleared sepsis diagnostic SeptiCyte® RAPID. Dr. Carlson is available for virtual meetings.
    
20. Thole 4 januari 2022 22:18

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    Great, thanks for the news. At least a bit of insights then.