Cambridge Cognition Share Discussion Threads

[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.

[40 fathoms] 16/5/2021 09:29

Only 3 weeks now till we get the FDAs final view on Aducanumab. Any form of approval, limited or otherwise and I think you will see a flurry of contracts for us from the healthcare space.

[40 fathoms] 04/5/2021 15:08

Thank you. That is a lot more straightforward !

[igbertsponk] 04/5/2021 09:08

Clickable (no need to complicate matters with adding spaces. Just change one of the https or www to a capital and links work).

[40 fathoms] 03/5/2021 14:37

Found it again .... worth a read for positioning of COG

https: //advisor.echelonpartners.com/research/content/CGN%20041621%20submit.pdf

If you copy the above link in to the search bar and then remove the space between "https:" and "//" it will work.

[40 fathoms] 24/4/2021 15:46

Here is a very interesting research report for Cognetivity Neuroscience a UK company that is listed in Canada. It does a very good job of setting out the market potential and the various competitive position of the various players. My take away from the report is that it is very clear that COG and Cogstate in Australia have this market pretty much to themselves.

The gap will grow, as we move in to and validate our position in both voice and wearables, many of our competitors are not yet even clinically validated on PC or tablets. Still it is a very interesting read.

www.advisor.echelonpartners.com/research/content/CGN%20041621%20submit.pdf

Sorry looks like they have moved the report from the link.

[40 fathoms] 24/4/2021 02:10

I have just come across this article from last year, starts on page 18, it sets out very nicely where COG sits in the nexus between CNS measurement and digital trials.

www.issuu.com/informapharmaintelligence/docs/rise_of_digital_tools_ebook

[oliversanvil] 21/4/2021 17:25

MM's Taking the micheal!

[davidosh] 15/4/2021 13:40

An investor in COG has dedicated a pledge to charity if the share price reaches £1.45 this year for a £200 donation to be made to a small deserving charity. I was only dedicated this week and looks like it will be hit this week at the current rate of growth in share price.

Hundreds of investors are doing the same



You can choose any company and any charity or simply match another investor and their pledge. I am hoping to get to £100k for lots of smaller deserving charities mainly but all donations much appreciated.

Lets hope the markets stay positive and investors are generous.

[igbertsponk] 15/4/2021 12:00

I added earlier. Was hard to get any, but already in profit on them which is nice....

[tratante] 13/4/2021 23:00

Indeed, thanks for that perceptive analysis 40 Fathoms

[dgwinterbottom] 10/4/2021 15:44

40 Fathoms - many thanks much appreciated

[40 fathoms] 10/4/2021 14:11

I think there are a number of possible reasons.

1) It is already clear they will blow away the @8.5 million revenue figure they have put out for 2021 and we are only 1/3 of the way through the year.

2) Following on from the point above this would suggest that they will also be meaningfully profitable this year. My working assumption is they will top GBP 1.25 million in PBT this year and depending on how the contracts build that could well top GBP 3.5 next year. Even at 125p per share that puts them on a P/E of 12 x next year and probably single digit for 2023.

3) On 7th April Goldman Sachs did a whole day of talks and panel discussions devoted to digital medicine and with particular focus on how digital clinical trials are now going mainstream. I understand it was very well attended.

4) With the FDA PDUFA date on ADUCANUMAB coming into view (7th June) people maybe positioning for a positive outcome. A positive result will be transformational for COG. It will open a large and near term market for delivering cognitive tests as a triage tool for potential AD patients. Think millions of tests a year being given at (pick your price) US$ 1.00, US$ 2.50, US$ 5 per test. That millions of tests per year will increase to tens of millions in the next decade. It is only COG and Cogstate that are in a position to serve this market. As a reminder Cogstate have done a 10 year deal with Eisai that will pay them a minimum of US$ 45 million over that period. Cogstate are very keen to emphasise that this is a minimum number and they expect very substantial upside.

5) As you suggest someone could well be building a stake, though I would argue with Nigel Wray and one or two other large PIs stakes anyone could well struggle to get to the 75% threshold required under a scheme of arrangement.

6) There is almost no 'traditional" institutional ownership of the stock. Maybe it is starting to gain some attention from the small cap insto crowd.

[dgwinterbottom] 10/4/2021 08:52

Anyone thought of reasons for the sharp rise in share price this week?

It has crossed my mind someone might be building a stake for a possible bid!!

[essential] 09/4/2021 08:38

Seems like covid is now responsible for every medical condition to keep the narrative going. Anyhow topped up on these - great prospects

[mike24] 08/4/2021 18:43

1ml UK now suffering long covid conditions, the problem is
being able to treat all of these different conditions,
dementia,CFS,ME, etc bringing on exaggerated symptoms as the
tragic recent case of CEO Kent Taylor suffering tinnitus

edit july 22 L/C sufferers now at 3million as the jabs are still given for elderly first
jab the valuable workers, us elderly can look after ourselves because of less contact
delivered groceries etc

[tictac] 08/4/2021 17:01

Something of a remarkable day!

mdchand - yes that is good news.

I've only recently invested here - seemed well run, with a strong product, and in an area I felt would grow. A bit of luck really that I invested when I did.

My holding is for the long term, so sort of irrelevant what the share price does in the short term - a pleasing confirmation of a decent stock choice though it may be.

[mdchand] 08/4/2021 08:59

Interested to note that this win was with a new Pharmaceutical Company - which helped ease a concern of mine - ie COG being overly reliant on 1/2 major Pharmas for business. If you look up leading Pharmas in the CNS space its the likes of Biogen / Pfizer / Novartis / J&J. I'm not saying it is ANY of these, but it could be.