Cambridge Cognition Share Discussion Threads

[smithie6] 23/6/2021 11:03

thanks for writing that.

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the test creator getting $1.5/test seems quite low, but I guess it depends how many tests that client body is committing to sell/use

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big market for the tests, yes I agree.

[40 fathoms] 22/6/2021 14:36

You will probably be aware that the FDA recently approved Aducanumab, as the first disease modifying drug in Alzheimers. The approval has proved controversial, primarily because at one point the trial was abandoned after a futility analysis by Biogen. Then after many months they said that upon closer analysis if you looked at a subset of patients on higher dosage the trial outcome was in fact positive.

This cherry picking of data after a trial has been completed is broadly viewed as a complete no no. So when it was submitted to the FDA for approval, given the controversy, they took it to an Advisory Committee (Adcom), the FDA does not do this often and although they don't have to they almost always accept the Adcom's view. For Aducamumab, almost to a man, the Adcom said that it could not be concluded that Aducanumab met its primary endpoints and that an addition trial was required to determine if it was an effective treatment. The FDA ignored the Adcom advice and approved the drug but with the requirement that it must carry out a post approval study. It will be many year before the data from the trial is gathered and available and in the meantime Biogen can market the drug without any restrictions.

In protest 3 Adcom pannel members have resigned. It seems principally over the lack of consideration given to the Adcoms views and the perceived lowering of FDA standards. In my previous post I was just highlighting that while it is noble to resign on a point of principal, Mr. Knopman weakens his position by then saying he will prescribe the drug.

Anecdotally, I hear that the phones are ringing of the hook at Neurologist office wanting to know about Aducanumab and their suitability for treatment. In the very near future when you go in to a GP or a Neurologists office and say I am a bit worried about my memory, they are going to sit you down with an IPAD or at a PC and make you take a CANTAB test (Cambridge Cognition) or a Cognigram (Cogstate) and after 10 -15 minutes you will be told that either you are cognitively normal for your age and lets check again in a year, or you are abnormal in certain areas and we need to investigate further. I honestly think that within 10 years we will see hundreds of millions of these tests administered every year and there are are only 2 companies that offer a fully automated, cloudbased, fully validated, digital test for this.

These tests will not just be used in AD diagnosis, we are going these tests or or variants there of to test for everything including concussion, post operative cognitive decline, chemobrain, stroke recovery, Parkinson's, ADHD, developmental issue even possibly non medical areas for example GCHQ is now actively seeking to manage the neurodiversity of its employees. I think this is a trend that will catch on in certain areas where problem solving in teams is a key part of the role.

The deal Cogstate has done with Eisai suggests they well be getting @ US$1.5 per test and gross margins will be in the high 90% area, plus they reattain ownership in the data. For Cogstate and Cambridge Cognition the ownership of the data is their moat as they will be able to make the test more and more sensitive.

[smithie6] 22/6/2021 13:39

Adcom, resignation, noble gesture

???????

if you have the time to spell it out to those of us not so well informed, I would be grateful & phps some others as well.

you seem to be very well informed

[40 fathoms] 22/6/2021 07:57

I tend to think the fall was just market related and profit taking. The volume was very low and it was mirrored in some other small cap stocks that are not AD related.

We are going to see a slew of good news over the next 3 months I strongly suspect before the end of the year we will break GBP 2.

As an aside, I thought it was interesting to note that one of the ADCOM members who resigned was asked if he would prescribe Aducanumab, he said he would still offer the medication to his patients when it becomes available, describing that as a “completely separate issue.” To some extent this seems to undermine his noble gesture.

[hatfullofsky] 22/6/2021 07:03

Controversy over the FDA approval of the Alzheimer's approval last month. Chair under pressure, 3 FFA advisory members quit one quoted as "the worst approval " which was rejected last year. Reported by FT Probably the cause for the fall yesterday

[mm84] 18/6/2021 22:49

Thank you very much for your insights 40.
Let me read and digest them and I'll get back to you.

[40 fathoms] 16/6/2021 11:48

mm84,

1) In AD yes, first you need to win a number of early stage trials as only a few will make it through to stage III, secondly you need to get to the end of stage II and from a starting point that could easily be 5 years, especially if you are assessing a therapy focused on MCI or the early stage of the disease. From where we sit visibility is pretty limited but there are often lots of clues or snippets on the internet.

2) To my knowledge they do not. They mainly just do the software and offer limited trial services.

3) There is plenty on the internet about what an eCOA is, I think you just need to understand that many of Cambridge's solutions are specialist/unique and you are probably better of using their integrated plumbing to knit everything together than using somebody else's.

4) No. Has not been spun out yet. I would need to look at what has happened to bring about the change in ownership you have highlighted. You can search on the companies house website and that should provide some indication.

5) I will leave that one to you. Given that they are already profitable and that margins are high, much of any incremental revenue will fall straight to the bottom line. There is no reason why, with a fair wind, they could not be producing profits of between GBP 8 million and GBP 12 million in 3 to 5 years time. Possibly even much higher if they sign a healthcare deal similar to the one Cogstate signed with Eisai.

[mm84] 16/6/2021 09:45

Thank you for sharing your knowledge 40. I really appreciate it.

Some notes: Yes, I'm comparing COG with Cogstate as Cogstate was the first one I loooked at and I'm obviously biased, but working on it :).

1) Regarding the US office, it has been open since 2015. I understand that these things take time, but 6 years??? And how has Cogstate done it while being headquartered in Australia?

Ok, I understand that the different phases take years (it reminds me of the ENTS in Lord of the Rings)but how much visibility do we have in relation to the trials they've been working on and how likely it is that these will translate into big phase 3 trials?

2) Regarding rater training and recruitment, I thought that COG also offered them. At least the recruitment with CANTAB Recruit. Are you saying that Cogstate has been lucky to perform those for large clinical trials whereas COG hasn't?

3) On eCOA, I must confess my ignorance (as with all the rest). I've tried to understand what it is exactly with little success. The best clue that I have found was a mention by the previous CEO on an interview from where I got the feeling that it was a less important product required by their clients like a "basic questionnaire and scales" (CEO's words).

Now that you've mentioned "CNS specific", "voice" and "wearables" I start to get the feeling that I'm way deep over my head.

4) Haven't they spun out Monument already? On the 2019 Annual Report Cambridge stated a 100% ownership whereas in the 2020 AR, it was down to 20%.

5) Which leads me to valuation. How does one put a number on this company? I know, I know, that's not how it works, but when you say that Monument isn't captured in the current valuation, how should it be captured? First there's the valuation of the core business (which I haven't even dared to calculate as I'm still learning the ropes)and then there's the valuation of a drug development business that no one knows what it is, what it's future will look like, it's funding needs, etc, etc. For all I know, it can be a drag on profitability for many years to come (if it remains 20% owned by the company).

Cheers,

[40 fathoms] 16/6/2021 08:59

In the same AD theme and while i am at it (please DYOR and this is not a recommendation) I would suggest you all take a look at a tiny little French company that could have a potentially huge digital application in the treatment pathway for Alzheimer's. They Company is called Voluntis the ticker is ALVTX FP.

They have an interesting business in providing a sort of digital treatment companion that is pared with specific drugs to help patience keep adherence, understand the significance of certain side effects and to monitor certain aspect of the patients response to treatment. They have 7 or 8 of these treatment companions under varying stages of development and regulatory approval and these are each partnered with a specific drugs from various global pharma names, in areas like oncology, diabetes and immunology. Eisai who is Biogen's partner on the development of Aducanumab and other AD drugs recently signed a deal with them for its oncology platform and took a very small equity stake but significantly when the deal was announced it was also said it would include an exploration of extending the project in to Neurology. It is on youtube and only in French, but during and IR call in May 2021 the company confirmed it would specifically be exploring a digital treatment companion for Alzheimers drugs. For those of you who like to dig a little bit I think this one might be a bit of a hidden gem, the company claim they will be cash flow positive in by the second half of this year.

[40 fathoms] 16/6/2021 01:16

MM84,

I am not sure I agree that they have not landed big contracts, there have been 4 or 5 contracts over GBP 1 million in the last 12 months.

I think you are probably making a comparison to Cogstate when you say this. But I think there is a couple of things you need to keep in mind.

1) It is true that Cogstate have, over time, won a few very large contracts. Most of these very large contracts are for phase III trials and in conditions where the trials are run over an extended time period, such as AD particularly trials focusing on the early stages of the disease. It is only with the opening of the US office that Cambridge has been properly positioned to compete for this type of work. So in essence you are unlikely to get appointed to a large phase III, unless you were providing services in phase II and most likely in phase I as well. So if you factor in the relatively short length of time that Cambridge Cognition has been properly addressing this market and given the multiyear length of most AD trials you will see that Cambridge has not yet worked its way through the system to the point where it is picking up these much larger trials. Although in the next 12 to 18 months I would expect that to change. So for example, I would expect them to win a large phase III trial of Cassava's Oral Simufilam before the end of the year. Across the two arms of the trial this will enroll 1,600 people and follow them for 18 months (I think in light of Cassava's advisory board it is reasonable to assume they are using Cambridge Cognition)

2) You should also keep in mind that Cogstate has historically provided a lot of non cognitive measurement services such as rater training and patient recruitment, which is lower margin work but bulks total ticket size.

As for eCOA, all I would say is barriers seem to be reasonably high and I am not aware of any other eCOA that is CNS specific. The barriers to entry are more related to the ability to be configured and VALIDATED to capture different types of CNS specific data (not just AD). I don't know this for sure but I suspect it to be true, no other eCOA can capture data from voice and wearables or certain very specialised CNS scales/instruments, because no one else has a validated commercial product in these areas. For example Cogstate does not have an eCOA and seem to be partnering with ERT in this regard.

With respect to Monument Therapeutics there is very little information about it. What we do know is that they are looking to spin it out. How significant is it ? It is hard to say for sure but looking at Monument's website( ) it is clear there is a drug development business sitting inside Cambridge Cognition targeting some pretty big therapeutic areas and in no way, shape or form is that captured in the current valuation.

[smithie6] 15/6/2021 22:48

40fathoms

thanks for all that info

I liked this part of your post
"Longer term I would expect that a cognitive test will be required as part of the annual renewal and premium setting process. Clearly you will have some ethical issues to cross but tests coupled with family history and other information can give pretty decent predictions of your probability of developing AD at least a decade before you show symptoms. I don't think the insurance companies and actuaries will be able to resist going down this route."

[mm84] 15/6/2021 16:43

Ok, I've read all the Annual Reports going back to 2015, I've listened to a bunch of interviews with the current and former CEO's and I'm now randomly googling stuff like neurovocalix, wearable technology, etc.

I was wondering if someone could help me with a few doubts:

One thing - among many - that I still don't understand is how the company was able to set its focus on commercialization back in 2015/16/17 with a dedicated team, an office in the US, etc, and still manage to do so poorly over the years. How come these guys haven't landed big contracts if their tech is so good? Note that I'm not being sarcastic here. I've been gathering the pieces and I - sort of - understand that COG is the absolute leader in voice and wearables. But the information is so scarce that I don't get it. Is this a culture thing that will be hard to change?

Other questions:
eCOA seems like a very easy product to develop with very low barriers to entry, but necessary to please the customers. Is this correct or am I missing something?

How important is Monument Therapeutics? In fact, what exactly is Monument Therapeutics?


Thank you in advance to those who can help me.

[40 fathoms] 15/6/2021 11:17

Yes. Health insurance companies Cigna and the like. Given the huge cost of this treatment, I would initially expect them to require an "insurer approved" cognitive test before allowing patients to start along the treatment pathway. This would be in addition to an initial test administered by a general care practitioner which is where most of the treatment referrals are likely to come from. Given that in the US the general care practitioner will receive a share (up to 6%) of the treatment cost they will have an incentive to push treatment. Given that the no label restrictions were placed on Aducanumab I would expect the insurance companies to place their own. Given that this check can be done by a cheap at home test it would seem like a sensible approach. The cost benefit to them is huge. Let say its $5 per test and the cost of treatment is going to be (all in) @US$75k per year. If they can knock back 1:15,000 claims or even defer that claim for a year they have paid for the testing.

I also think you might find that while on the treatment they will require regular cognitive testing to determine if the therapy is having an effect and should be continued.

Longer term I would expect that a cognitive test will be required as part of the annual renewal and premium setting process. Clearly you will have some ethical issues to cross but tests coupled with family history and other information can give pretty decent predictions of your probability of developing AD at least a decade before you show symptoms. I don't think the insurance companies and actuaries will be able to resist going down this route.

[smithie6] 15/6/2021 08:24

insurance companies ??

[40 fathoms] 15/6/2021 01:06

In response to the question on the LSE board about expected revenue for this year. Current consensus/guidance is for @8 million. I think these contracts would be in addition to the guidance numbers and will add @ 500k to this years revenue and the balance will to next 22/23. My guess is for this year we do @ 9 to 9.5 million revenue and a PBT of @ 750k and that will double to @ 1.5 million in FY22.

Those numbers exclude any additional large contracts that are signed or any licensing deals done in the healthcare space. I would not be surprised to see them sign up with and a number of HMOs or insurance companies prior to the end of the year. A few deals like that could add meaningfully to annual recurring revenue.

[40 fathoms] 15/6/2021 00:59

Todays new contracts signed are going to be the first in a deluge in my view. We can expect to see a lot of good news between now and the end of the year. I would also expect to see the company up its guidance when it provides a mid year market update.

[40 fathoms] 11/6/2021 07:19

Cambridge Cognition Holdings Plc (AIM: COG), which develops and markets digital solutions to assess brain health, is pleased to announce that it will be joining the University of California, San Francisco (UCSF) Brain Health Registry as a cognitive assessment partner. The Brain Health Registry is an online platform designed to speed up the discovery of treatments for Alzheimer's disease, Parkinson's disease, depression, post-traumatic stress disorder, and other brain disorders.

This is going to be the first in a stream of announcements, the approval of Aducanumab will set the whole sector alight not just AD, money is going to pour in for all CNS conditions, this really is the final frontier in medicine and we are still working out not only how to measure but even what to measure we have not even started to scratch the surface of what is possible.

[40 fathoms] 07/6/2021 22:55

BINGO - Aducanumab approved

[hatfullofsky] 07/6/2021 22:51

Times article

Alzheimer’s drug, aducanumab, gives first new hope in 20 years

The first new drug for Alzheimer’s disease in nearly 20 years won conditional approval today, offering fresh hope for British patients and millions of others worldwide.
The US Food and Drugs Administration (FDA) said the company Biogen could market the drug, called aducanumab, in the United States, but that it would need to complete a further large clinical trial to confirm its benefit to patients.
Regulators in Europe and the UK are not expected to make any ruling until the autumn but the US decision was hailed as promising by British campaigners.
Professor Bart De Strooper, the director of the UK Dementia Research Institute, said: “With no effective therapies currently available to modify the progression of this devastating condition, this is a major milestone for the millions of people living with Alzheimer’s.” He warned however that “controversy and uncertainty” surrounding trials of the drug might limit the impact of the new treatment.
Biogen’s decision to file for approval was a surprise after clinical trials involving over 3,000 people were stopped early in March 2019. An initial analysis showed the drugs were unlikely to make sufficient improvements to people’s memory and thinking.
However, later that year the company said it had undertaken a new analysis with more data that became available after the trials stopped, focusing on people who had taken the drugs for longer. It said that analysis showed a high dose could slow the decline of cognitive skills and keep people able to carry out daily activities for longer, and requested approval on that basis.
The drug is an antibody designed to target amyloid, a protein that builds up in the brain at an early stage of Alzheimer’s disease.
While treatments work to reduce symptoms for a time, aducanumab aims to slow the underlying disease itself.
The FDA said it was basing its unusual conditional approval on the ability of the drug, also known as Aduhelm, to clear the toxic proteins from the brain. For Biogen to continue marketing the drug, it will need to complete a trial to confirm removing the plaque offers cognitive benefits.
Professor John Gallacher, director of Dementias Platform UK, said: “Although I suspect this was a close decision, the FDA obviously gave aducanumab the benefit of the doubt.
“Apart from the chance for patient benefit, the scientific impact of this decision will be the real-world evidence it creates as the progress of people taking the drug is monitored.” He said it could also act as a catalyst for further drug development, suggesting other companies might “dust down” their own similar drugs for further work.
Many experts are uneasy with the ruling. Dr Caleb Alexander, a drug safety and effectiveness expert at the Johns Hopkins Bloomberg school of public health, who was involved with an initial FDA decision to reject the application in November, told The New York Times that relying on a re-analysis of a trial was “like the Texas sharpshooter fallacy – the idea that the sharpshooter shoots up a barn and then goes and draws a bullseye around the cluster of holes that he likes”.
Speaking before the decision, he warned approval would set a “remarkably dangerous precedent” for not only Alzheimer’s research but also broader regulation of prescription drugs.
The American Geriatrics Society had urged the FDA not to approve the drug, citing concerns including “reliance on a single, incomplete trial as the basis for approval” and the fact that it was not free of side effects.
There are about 850,000 people living with dementia in the UK.
Dr Richard Oakley, head of research at Alzheimer’s Society, said: “It’s promising to see that aducanumab has been approved for use in people with early stage Alzheimer’s disease — the first drug to be approved in nearly 20 years by the US regulatory authorities.
“We await the opinion of the European Medicines Agency and the outcome of any application made to the UK regulatory authorities, to give clarity to people with early Alzheimer’s disease in the UK.” He said that with the drug only likely to benefit a proportion of people in the early stages of the disease, “we must keep searching for drugs for all stages of Alzheimer’s disease and for other types of dementia”, calling on the government to honour a commitment to double dementia research funding.

[minsky] 04/6/2021 08:40

WT you're right the capital markets day has been an annual event at least since 2019 so Paul Scott's off-the-cuff remark isn't necessarily right.

[smithie6] 03/6/2021 23:26

"At 31 December 2020 the Company had over GBP3m of cash, resulting from the increased order flow, reduced spending, and the successful equity placing of GBP1.4m, before costs, in March 2020."

"Loss for the year GBP0.4m,"

& turnover is increasing a lot

so, at first sight it doesn't look like the co. needs to raise money

but depends I guess how slow clients are in paying for these contracts & if they pay anything up front, or just after completing each stage of a project
(the COG workers on new projects have to get paid each month, by someone !, cant give 'em an IOU !)

[w t tutte] 03/6/2021 23:14

Minsky, They do have these investor days every year, so I am not sure it necessarily signals anything. Also, it dose not seem like they need a CR operationally, as they are now cashflow positive. So if they were to come to market, one would suspect it would be to fund some M&A. The CEO seems very commercially focused and does not seem like the type who would pursue anything frivolous.

[minsky] 03/6/2021 12:36

Interesting Paul Scott makes an inference based on W T Tutte's previous post:
Upcoming capital market day implies upcoming fundraise.
Who knows...

[tomps2] 03/6/2021 09:24

Paul Scott mentions Cambridge Cognition (COG) at 16m50s in the latest piworld Interview.

Watch the video here:

Or listen to the podcast Here: hxxps://piworld.podbean.com/e/piworld-interview-paul-scott-june-2021-update/

[w t tutte] 31/5/2021 13:08

They have an investor day coming up on 16th June where they will highlight new technologies. Can use the link below to sign up.