Seems to me like a few people are a bit nervous at the moment.
We are actually waiting for three announcements that could drop at any time (among others).
1. Ovarian Results for independent confirmation from Griffith University on the BARD1 ovarian test 2. Internal Prostate SubB2m testing results to see if the SubB2M marker indicates Prostate Cancer 3. Product Launch of EXONET technology in the second quarter (April / June)
All three announcements could drop at any time based on their indicated timeframes.
So what's likely to happen IMHO?
On Announcement 1:
Well we already know that the SubB2m result for Ovarian Cancer was released with 100% sensitivity and specificity across ALL STAGES of ovarian cancer (you cant get better than that!). This was released / validated by the Griffith University in Feb and caused / started all the recent fuss.
But remembering that SubB2M is a pan cancer marker (i.e. it picks up cancer but won't tell you which one) we are waiting to find out whether Griffith University is going to validate the BARD1 kit on the Luminex platform to indicate Ovarian Cancer in an independent study.
So what we know based on the studies so far is that if a woman has ovarian cancer then the SubB2M will show cancer exists for even early cases. Now we need the test that will show if its Ovarian cancer or something else.
We also know from September 2020 that the optimised RUO BARD1 kit (& the one with less peptides than the original) was shown in a study at the University of Geneva to 'show good discrimination between cancer patients and controls'.
The original BARD1 test showed previous results of 88% sensitivity and 93% specificity for ovarian cancer in average risk women and 89% sensitivity and 97% specificity in high risk women. These results alone are very high!
But the issue is it was not on an easily commercialised platform and was very complicated. Hence not as easy to use in the real world.
So they sent the test to Thermo Fisher to take it to a standard industry platform (Luminex) with the aim to optimise the test and make it easier to use (i.e. using less Peptides).
From a long term share holder perspective it seemed to take AGES!! But I know in the real world this is not so easy (all I have to do is wait - they had to do the science).
This optimised test on the new platform eventually went to the University of Geneva for the study to confirm if it still worked for ovarian cancer with the result saying ''yes it does'' released in September last year and now we are waiting for Griffith University to finally validate those results here (hopefully with more detail). Think of the progress here at the stage in mining terms of having some great hits in the drill results and now we are waiting for the resource upgrade / creation.
If it comes back successful (is there any reason it will not?) then I speculate the next step will be to combine the BARD1 test (which came from BARD1 pre-merger) with the SubB2M marker (which came from the Sienna side of the merger) to make an all encompassing test to indicate / test for Ovarian Cancer and / or monitor for recurring cancer / cancer progress.
The BARD1 platform has at the same time been looking at Breast Cancer and Lung Cancer along the way with pretty good results. But again - if validated and combined with SubB2M then the results could be amazingly good.
On Announcement 2:
We know that BD1 has released results showing great results for Ovarian Cancer and Breast Cancer on the SubB2M marker. We also know that they are internally looking at how well it will work for a range of other cancers including Prostate and Pancreatic.
In the interview with Alan Kohler the other month it was mentioned that they were doing the internal early work on Prostate cancer and that these results may be released in Q1 (just passed) or early into Q2. At the time of the interview it was indicated there was nothing at that stage to indicate the marker wouldn't work with Prostate Cancer - but time will tell. These preliminary results could drop at any time.
The strategy there seems to be to try and combine it with a PSA marker for prostate cancer to make the test better and get it to market faster
But we also know that Pancreatic cancer has / is being looked at via their updated pipeline. This whilst I don't know when, an announcement on this may also drop at some random time in the future. .
We also know the Australian Government was throwing money at them last year to fast track the development of the SubB2M marker into a commercial breast cancer test. The aim was to have something to market within 2 years (the money was announced in Sept 20) so progress announcements on this could drop as they meet milestones along the way with an aim to have a breast cancer blood test by Sep 22.
No wonder they are throwing money at them to fast track - who else has a blood test (albeit a Pan Cancer test) that indicates a person with breast cancer has a cancer with 100% specificity and 95% sensitivity across ALL STAGES OF CANCER!
On Announcement 3:
The EXONET patent for the US market was only approved in Jan 21, and the launch of the RUO (research only) EXONET product is to be launched at any time in Q2.
As outlined in the previous announcements they indicated the exosome market is expected to reach $2.2B by 2030 and BD1 is positioned to be a key part of the exosome isolation process in this market. We saw the positive Pancreatic Cancer results released on EXONET technology only last month as the pre-market teaser to a launch IMHO.
Don't forget at any time we might get left field announcements (like the diabetes one the other day), updates on hTERT sales (for bladder cancer), updates on BARD1 Breast Cancer results, or the long awaited (by the looks of the legal action) BARD1 Lung Cancer test progress.
There is heaps happening - all for under $250 mil market cap.
Do you need a reminder on the annual size of the markets they are chasing here?
People seem worried due to having expectation on timeframes for additional announcements that have only been missed in their heads by around 2 weeks so far.
This is the biotech industry - things take time!
Wasn't it Warren Buffet who said if you aren't willing to hold an investment for 10+ years you shouldn't be holding it!?
Patience is a virtue.
Cheers
Hevlet
BD1 Price at posting:
$3.24 Sentiment: Buy Disclosure: Held
(20min delay)