Charles Jillings, CEO of Utilico, energized by strong economic momentum across Latin America. Watch the video here.
Vincent Vega
The whole premise of this test is that it utilises CIZ1B
The quickest route to market is via LDT in a CLIA accredited facility (Corepath)
The China test cannot take place without Cizzle supplying the reagents & monoclonal antibodies. Therefore running 2 sets of test simultaneously can't take place.
ICCAMT are contracted to develop the test and bring it to market, and to that end, i think that the test will be launched in USA, and because China will be using the platform, i think it is fairly certain that Jess will be that platform, because it doesn't make sense to start all over again with a new platform. After all, the longest part of getting it to market is validating the the technology, and this can be done by using data gathered in the USA test. So once in the market in USA, i expect the time required to get into China market significantly reduced.
Biotechne already in China, so will be able to supply the hardware. Don't forget that the agreement already includes for Cizzle to be paid for the supply of the antibodies and reagents, in addition to any other services provided using CIZ1B.
Neil
Hi Fastfood
I don't like putting timescales on it for obvious reasons, and if i miss it by a few days/weeks it doesn't suit someones timescale.
However, if you are reading / thinking the same as me.....
before end of March, either 2-3 RNS's or one HUGE one ;-))
Neil
You know i don't give a flying fig for the day to day share price, but watch and see what happens in the next few days.
£30k worth of trades does not impact the MC to the extent of 9.2% drop. (Approx £800k)
My bet is the price has been dropped to facilitate collection of shares cheaply.
Neil
Hi Bearsandbulls,
I said previously when commenting about Grails claims on Galleri, that it is important to look past the attention grabbing headlines.
At first glance, you would be forgiven for thinking (that some on here may have) that they are virtually about to launch their test kit into the market.
When you look at the actual content of the report, it makes it clear that this was only a study, and is in the very early stages. In fact one paragraph, states "could be a starting point for developing a new generation of screening tests for the early detection of cancer"
Their study reports sensitivity of 80%, but across stage I & II cancer. Ours is 95%
Yes, you could well be right in thnking that they are sounding out the market for potential funding.
Neil
Interesting that they decided to release this "news" in the last day or two, considering it was previously released 8th May 2023.
One of the things to watch out for is the claims that they can detect multiple cancers.
The problem there is that many blood tests to detect tumour markers are available or under development, but many are hampered
by the fact that tumour markers may also be produced by normal cells in the body. In contrast, the Cizzle
Biotechnology test is based on tumour-specific technology. A number of the tests specific to lung cancer
look at particular alterations of circulating DNA (cDNA) and RNA (cRNA), and are used to determine the
precise type of cancer, define which therapy is more likely to work and assess the effectiveness of a particular
drug. Few tests are aimed at early detection and reducing significantly the number of false positives achieved
via CXT and chest CT scans.
(Clinical biomarkers have been instrumental in reducing mortality in cancer patients [29], however lack of understanding of the capability of biomarker tests can result in inappropriate use and lead to over-investigation of disease that is incorrectly assumed to be malignant [30]. Furthermore the value of some has been questioned especially in relation to their use in the initial diagnosis of cancer [29], [31]. Lack of clarity usually arises when a marker is found in other pathologies or when, like PSA, it is not specific for neoplastic cells.)
Neil
The deal was structured by:
£1m by way of issue of 47m shares at a price of 4p per share, when the share price on the previous closing day was 2.53p - a premium of 56.9%
£880,000 by way of issue of 22m shares at a price of 4p per share, when the share price on the previous closing day was 1.65p - a premium of 135%
If shares had been issued at their true value, then we would have had to issue in excess of 92m shares.
The CDT put option premium was settled by way of issue of 7,371,557 shares at 1.6p per share.
Total cost was £2.2m factoring in everything, so anything above that is a good investment. Especially if you factor in the true cost had it not been for the shares premiums paid by the investors.
As Brondby says, we don't know the true value yet. It may be considerably more in time. Until the BOD tell us their intentions, (sell some and hold the rest for future, , sell all, hold all) we just don't know. But it does give us options and is pretty much guaranteed funding for future.
Neil
Apologies, but it's another long one...
So iv'e been looking back over my notes, interviews, etc, and this is what i found -
We know Allan was in China at the end of September, at the invitation of the Department of Business and Trade,.
Rahul Agarawal is the UK diplomat, and arranged by PhRIDA (Pharmaceutical Innovation and Research Development Association) where a "mini mission" of 11 Uk companies were present.
Allan presented "PROJECT 3 " Cizzle Biotechnology to the audience at 3pm on the 25th Sept followed by one to one meetings and investment dinner with key China healthcare organisations.
He has stated that he will report back what is happening on these meetings.
I also made note of a few statements from previous interviews. Among them were:
Whilst speaking about acceleration of lateral flow kit development -
"Dr Coverley will be knocking on the door of the next product"
"We are going to be doing that at the same time"
"That will be for another interview"
"A lot more to tell you about, at the right time"
"Chapter 2 coming up"
It seems there is a lot of news in the pipeline.
In the last prospectus for the E3 funding, -
"the company will also seek LICENSING AND JOINT VENTURE FEES" I said previously about the alternative revenue from licensing deals. Now joint ventures too.
Now here's an interesting observation from Bio-techne business development -
"......our teams focus is on building business development and technology in-licensing opportunities with owners of existing innovations or intellectual property, that are seeking to further develop products, or introduce their technology to larger markets".
Just a mention too of the original investors when CIZ did the IPO.
Their warrants are due to be exercised by 14th May 2024, at a strike price of 15p.
Neil
Hi Vincent Vega
Published early June and presented to American Society of Clinical Oncology on the 3rd.
(ironically, a week prior they incorrectly advised 400 people they had cancer, when they didn't)
An article was updated last night and is available on Red Whale website. Then click on the Pearls tab, and you will see it.
woodyjohn40, We don't need an MP on board. We are already in the preparation of the clinical trial and launch of our test to support the NHS.
Jace86, specificity wasn't bad to be fair, but that acts in an inverse relationship to the sensitivity. Sensitivity is the more important factor, as that is the one that states that you have cancer, so the higher this number, the higher the accuracy, and the lower the false negatives.
On the numbers being mentioned, 334 million Americans, 50% of who have medical insurance, so in round numbers, 115 million. Life insurance companies are now taking huge interest in early detection screening as it is seen to be a way of reducing their costs in later diagnosis cases. Some are even using the tests as "add ons" or "bonuses" to health plans and other workplace programs.
In the grand scheme of things, , i REALLY cannot see any downside to this company.
Neil
So the Galleri test currently being trialled by NHS -
Results from the SYMPLIFY study published in The Lancet Oncology on subjects suspected of having cancer, shows:
66.3% sensitivity - so of the 6000 subjects, it only detected cancer in 3,978 cases. WOW.
2,002 people had cancer and it didn't pick it up.
Sensitivity for stage 1 cancers was as low as 24.2% Even bigger WOW. I thought this test was supposed to be the bees knees?
Now i find that the "undisclosed cost" to the NHS of the Galleri test (1 million of should the results be to NHS expectations) is £390 per test!
£390 x 1 million is £390 million - That is more than the entire annual cost to the NHS of the COMBINED breast and bowel screening program!!!
Compare that to our test's claimed sensitivity, and suggested cost of $100
then add into the equation the issues with Grail's antitrust problems, the news item yesterday about record cancer cases, cancer detection targets being missed, calls for Government intervention in funding research, NHS must be absolutely screaming for our test to get to trial.
Neil
Allan does not put out RNS's just to give investors a warm feeling.
He puts them out on "significant news" which i fully support. It reduces the traders flipping shares for a few quid here and there on a speculative rise.
There will be some "significant news" coming on various fronts, and the sp will react accordingly.
The CDT shares are an unknown at the minute, as we don't know if we sold ALL of them, (and at what price) or SOME of them (again at what price) or kept hold of them.
He did say in a previous interview that he liked having the option of doing any of the above.
Neil
VincentVega
By no stretch of the imagination do i claim to have any affiliation with cell biology.
However, i can sometimes pick things up.
As you can see from the paragraph, there are a lot of terms that are beyond most peoples understanding. (me included)
As i understand it:
Put simply, the paragraph is a description of how genes /cells interact with each other .
Overexpression can be thought of as a switch. In Gene biology, this switch is a gene that will turn on a cytokine.
A cytokine is a protein that tells the immune system to go and attack what is thought of as the enemy. (cancerous cell in this instance). One problem with this is what is known as cytokine storm
You may recall Professor Whitty and Van Tam talking about this during the initial covid pandemic.
Cytokine storm is where the immune system completely overloads the body with immune cells, which cause further problems and is a vicious circle, of the body producing even more cytokines, and shuts down organs. (lungs in the case of covid - hence the number of people on ventilators) The key is inhibitors, or modulators, which will control or block the release of these cytokines.
All the numbers - mir-183-5p for example are the genes/proteins which were used in the particular experiment, in as much as ours is CIz1b.
The paragraph in question is not of any interest to me at least because the term "metastatic" refers to the stage of the cancer.
In this case it means that it is of such a stage that it has migrated from the original source to other organs in the body.
Typically stage 4. This is why there is reference to the liver, while the discussion is about breast cancer (BC) Main sites that breast cancer metastits occurs in, is the liver, and lung.
Which brings us back to why we have chosen breast cancer as the next test - because of it's association with lung cancer.
Neil
Evening all.
I apologise in advance if this ends up a long post as i am writing it from different sheets of notes.
I have been looking at the latest patent submitted 23/03/23, priority to USA US202302266327A1 Publication date 24/08/23 Status - Pending, to see if there are any clues to Bio-techne or others.
Couldn't find anything there, but under the particulars of the Patent, i did note a number of things.
i have been banging on for a while about developing our test to detect other cancers.
Particular 031 states:
"In particular, the cancer may be lung cancer"
Okay, no surprise there, as that is the basis on what the company is.
However, Particular 030 states:
" The cancer may be selected from lung, lymphoma, kidney, breast (we know that we are already currently developing a test for detection of breast cancer), liver, bladder, ovarian, or thyroid cancer" - so this supports my theory that we are looking at even more kits to detect a larger range of cancers, hence the reason we have engaged others to develop further antibodies.
The next few particulars are the ones that really struck me.
Particular 032 states:
"the present invention further relates to a method for treating a subject with cancer comprising administering to the subject , a cancer therapeutic wherein the subject has been identified as having cancer by the method of the invention"
Remember previous discussions regarding companion diagnostics / re-purposed drugs?
Particular 033 states:
"the current invention also provides an anticancer drug for use in treating cancer where the subject has been identified as having cancer by the method of the invention"
REALLY? i know what that suggests to me.
Particular 034 states:
"the current invention further provides an anti-cancer lung cancer drug for use in treating lung cancer wherein the subject has been identified as having lung cancer by the method of the invention"
Again.... REALLY?
We know that we are involved with Fairjourney, Corepath, Bio-Techne who in turn, are involved with drug manufacturers etc.
Now, given that we didn't even have a clue that we were working with Bio-Techne, let alone completed an evaluation programme, is it possible that we have found a company whose drug(s) will compliment our test? Just a theory, but make your own mind up.
Before posting this, i did seek a second opinion on what i was seeing / interpreting, and that person confirmed that they also understood it to be as i did.
Neil
Evening Greend100
Better than that, we have clinical validation available from 486 plasma samples from 4 independent sample sets in support of our retrospective data.
Still looking into the information i mentioned the other night, which i will post further on when i have my notes correlated.
It does appear to be quite something on the face of it, but i just want to be sure i am right in what i am interpreting before i put it up.
Neil
Jace
i think that there are a few typical reasons for the share price being where it is and the markets apparent missing the significance of this company, and one very big, and pertinent reason -
The obvious reasons are:
1. We are a pre-revenue company, so for all the predictions of a meteoric rise, it is just that at present. i.e. predictions, so the markets have no tangible way to determine where they think the true value should be. But, when commercialisation starts, and contracts are forthcoming, then i think we will start to see a massive difference.
2. We are currently at development stage of our product (s) so again, nothing concrete to base any valuation on.
3. The markets presently have a bit of a downer on pharma stocks generally.
But to me, the biggest obstacle is /was THERANOS and it's subsequent crash.
At the time, all based on unproven claims, the company attracted huge corporate and private investment to the point that it soon had a market cap of some $10 BILLION.
Concerns soon began to appear about the claims about the claimed technology, which proved to be false, and resulted in a spectacular fail with the CEO and the President being jailed for fraud.
It seems to me that the markets are understandably very wary of companies particularly in the bio sector, where unproven technology is the issue.
The sooner our test is successfully launched, the sooner these fears will be put to rest. Lets see how much you will have to pay for the shares then!
All in my opinion.
(PS found something else that i think could be significant, but need to look further into as well)
Neil
Some interesting bullet points from Institute of Cancer Research position statement:
"Accessing biomarker tests on the NHS"
* We believe that it should become standard within the NHS to perform molecular profiling of all cancers. We need a broad expansion of biomarker testing for people with cancer.
*I .....Companion diagnostic tests for drugs.....ideally, diagnostic tests would be made available on the NHS in England even before the associated drug has gained approval. We believe that tests could be categorised as "essential " or "desirable".
Tests that are verifiable and proven to work in a clinical setting would be categorised as "essential".
* We believe that it is essential that NHS institutions should be able to use genetic tests that have been through rigorous in house validation and quality control WITHOUT REQUIRING A CE OR UKCA MARK
Now that last one is really interesting in view of the fact we are engaging in the market launch and preparation of clinical trial to support the NHS.
Neil
I don't wish to pee on anyone's strawberries, but the new antibody is nothing to do with us.
This is a CIZ1 polyclonal antibody.
CIZ1 is a primary antibody - a basic building block if you like.
Our Patent is for the discovery of a variant of CIZ1, monoclonal antibody,which in this case is the splicing of exome 14 which gives us CIZ1-b
There are lots of antibody suppliers that supply CIZ1 antibodies, but you will find not one of them are advertising CIZ1-b, and that is because they can't.
Cizzle bio-technology own the intellectual property rights.
Hope this hasn't dampened enthusiasm, but i think it is only right to make sure we are all given the right information. This does not however, detract from where this company is going in my opinion.
Neil
News from USA 21 hours ago is that New York is in the final stage of implementing into law, requirement for biomarker testing for cancer detection.
Final stage is for Governor Kathy Hochul to sign Senate Bill 1196a/Assembly Bill 1673a into law.
This bill will require all state regulated health plans in New York including Medicaid, to cover comprehensive biomarker testing for millions of residents.
Millions - and that's just in the state of New York.
Medicare should be very interested in this since a study shows that patients that received broad panel biomarker testing and subsequent targeted treatment saved around $8,500 a MONTH in total care cost compared to those receiving narrow panel biomarker testing.
Something i posted previously about our biomarker being used for targeted treatment - i knew it was of importance alongside the actual diagnostic part of the test, but i didn't quite realise just HOW MUCH the importance this part of the
CIZ1b story is.
Once a patient has been diagnosed with cancer, that isn't the end of the test. i.e it's not just a one time thing. As well as being invaluable in developing and identifying drug / therapy treatments targeted at specific cancers, apparently, it is just as important to carry out repeat tests during treatment in order to observe any changes in the cancer, or resistance to treatment, so adjustments can be made accordingly.
So repeat revenue stream in addition to the initial test.
Neil
From last week's tweet "this improves reliability and sensitivity through precision sample handling , effectively delivering both size analysis and a quantitative result"
I note that Bio=techne also supply a fully automated sample pipetting robotic system known as ASSIST PLUS which is used in conjunction with JESS that gives "foolproof liquid handling, ensuring precision and accuracy"
I wonder if this will form part of the test. Anything that gives our test more accurate and sensitivity results has to be a benefit.
Fairly recently i responded to one of Widglide's posts, asking him if he understood the relevence of the role Artificial Intelligence or Bio- Luminence would have.
Let me put a bit of context to that question.....
One of the benefits of JESS is the module that allows multiplexing of samples, giving the ability to reproduce results in bio-luminence data.
For those that are unaware this is a way of detecting the biomarker and displaying it as a pattern (there are numerous examples of this in Cizzle's / Dawn Coverley's research)
To put it very, very simply, as an analogy, it is like the old colour blindness tests where you were presented with a picture of a page of coloured dots, and in this picture, there would be a number in slightly different coloured dots that indicated a number or a dolphin for example.
Sometimes you could see them easily, but other times, they were hard to distinguish.
Being able to detect these patterns earlier, makes our test more accurate.
Now, just imagine if we combine this aspect of the test with Artificial Intelligence Machine Learning.
Machine learning means that thousands upon thousands of samples can be scanned, and the algorithm will start to learn what to look out for. The more it learns the tell tale signs, the earlier it will be able to detect them. Not only that, but it will be able to detect earlier, and smaller stage of cancers than could EVER be detected by humans, again making the test far more accurate.
The "Gold standard" of cancer detection is currently CT scan.
2 problems problems with CT scans is
1. The number of false positives is still too high.
2. The cancer has to have developed to a size that is able to be detected in the first place.
I can see the day coming where CT scanning is no longer considered the Gold standard.
Neil