Forum Topics CGS CGS ASX Announcements

Pinned straw:

Added 2 months ago

Cogstate seems to be executing well with an ever increasing pipeline and expanding into new disease domains. Margins may compress in the short term as they tool up to enable this:

Business Update

All results in US$, unless stated

Cogstate Limited (ASX:CGS), has today released a business update ahead of its Annual General Meeting of

shareholders, which will take place at 11am AEDT today.

Market Conditions

The demand for Cogstate services continues to grow, reflecting both growth in the market for R&D in central nervous

systems diseases as well as growth in market share by Cogstate.

Each of the last four quarters (from 2Q25 to 1Q26) has set a new record for the number of sales opportunities

identified by Cogstate, with those opportunities in the September quarter (1Q26) 72% higher than 1Q25.

The growth in sales opportunities identified reflects an expansion of both the Cogstate customer base and entry into

new indications. Cogstate management continues to carefully monitor win-rate from the associated increase in

proposals volume and is assessing the full impact of new channel partnerships, with further updates to be provided

throughout the course of the year.

Clinical Trials Sales Contracts

For the September quarter (1Q26), Cogstate executed $21.4 million of sales contracts, which is the second highest

quarterly result in Cogstate’s history. The quarterly sales contracts represent an increase of 88% compared to the

$11.4 million of sales contracts executed in the previous corresponding quarter (1Q25).

The following table shows the reduced concentration of the value of sales contracts executed in 1Q26, delivering on

Cogstate’s growth strategy, compared to the full FY25 year – noting that 1Q26 data will not necessarily be reflective

of the full FY26 year:

Indication

FY25

Sales Contracts

by Value

1Q26

Sales Contracts

by Value

Alzheimer’s disease 56% 33%

Rare disease 19% 19%

Narcolepsy 6% 11%

Depression 5% 17%

Parkinson’s disease 4% 2%

Schizophrenia 2% 14%

Other 8% 4%

| Page 1Financial Outlook 1H26

Subject to sales contracts executed up to 31 December 2025, and 1H26 revenue yield from those, revenue for the

December half year period (1H26) is expected to be:

• Approximately 18% - 20% better than the previous corresponding half (1H25 $23.9m); and

• Closely align with the most recent June half year period (2H25 $29.1m).

In respect of margins for the December half year period, we reconfirm guidance provided with the release of the

FY25 results in August, specifically:

Continuing to invest for growth: Both direct costs and operating costs will increase from FY25 to FY26 as

Cogstate invests for growth:

o Additional science resources to support expansion into psychiatry and mood disorders;

o Additional resources based in the Asia-Pacific region to support a growing customer base there;

o Continued increase in expenditure related to data engineering to bring more automated data insights

to Cogstate customers; and

o Engineering expenses associated with development of AI tools.

Potential margin impact of growth initiatives: Subject to revenue growth in FY26, the increase in

expenditure may result in a small decrease in margins (0-3 percentage points).

Due to the volume and value of sales opportunities outstanding presently, it is not possible to provide accurate full

year FY26 guidance at this stage.

Held IRL

mushroompanda
Added 2 months ago

The big takeaway from me: Large Phase 3 Alzheimer's Disease (AD) used to make up the bulk of the cake, but now it's just the icing.

Cogstate won $14.3m worth of non-AD work in Q1 FY26. That's a run rate that is large enough to lead to top line revenue growth for the company, without any AD related work. We'll have to see how sustainable this is.

b6a2b32bd6d30ad85074e206b45a52b258d761.png

I attended the AGM in my physical form and spoke briefly with Brad after the formal presentation. He believes that they'll end FY26 with a contract win AD/non-AD mix similar to that of last year. That could only mean he's confident in snagging some large AD work in the remainder of this FY.

32

Slew
Added 2 months ago

@mushroompanda I’m curious what the attendance was like at the meeting? 

From the Q&A (I was online) it didn’t sound like there were any fund representation and questions were pretty brief.

14

mushroompanda
Added 2 months ago

@Slew very minimal. Maybe just a handful of outsiders.

15

Shapeshifter
Added 2 months ago

Encouraged by the recent meeting with Brad and the SM chatter I've spent a bit of time over the past few days catching up on Cogstate having previously owned it about 3 years ago.

I've been making my way through the Investor Insights Series which is on the Cogstate website and wanted to put down a couple of points mostly for myself but maybe there are others interested as well. @mushroompanda may have mentioned this already but if you are interested in the company the Investor Insights Series is excellent. I found the sencond one in particular, Unlocking Alzheimer’s Breakthroughs: Enabling better data-driven decisions to advance drug approvals, surprisingly insightful. It runs for an hour, is chaired by CEO Brad O'Conner and has a diverse and balanced panel of Kaycee Sink who is the Chief Medical Officer for Cogstate also a practicing geriatrician, Akash Tewari an Equity Analyst for Jefferies who covers Lilly and Rachel Colite who is the executive vice president of Clinical Trials at Cogstate. To me it feels like a rigorous scientific discussion.

Firstly Kaycee Sink spoke about a new drug being developed by Roche to treat Alzheimer's disease called Trontinemab that was presented at the recent Alzheimer's Association International Conference (AAIC) that took place in Toronto in July. This drug is important because it uses a novel new technology called Brainshuttle to transport the antibody across the notoriously impermeable blood brain barrier to the active sites inside the brain where it breaks down the amyloid. The amyloid is thought to be responsible for the development of Alzheimers disease. This Brainshuttle mechanism increases blood brain penetration of the drug by 50x. What the early data has shown is a reduction in amyloid by 90% after 6 months of treatment. Importantly the ARIA or Amyloid-related imaging abnormalities is also low at only 4% for the higher dose treatment arm. Roche is now heading to Phase 3 trials as @mushroompanda noted and this is work that will probably be won by Cogstate.

Secondly Akash Tewari discussed the Lilly Trial (Trailblazer-Alz-3) which is a current Phase 3 trial looking at a drug called donanemab in early stage Alzheimers disease and in some cases pre-symptomatic patients ie patients are identified on biochemical markers only. This trial is ongoing but Akash said Lilly, "have a sense of what the treatment arm is doing indirectly and the feeling is of some excitement in this population." So far the released data shows only 1/3 of the usual ARIA rate in this population and significantly it is looking like this drug will prevent Alzheimers progression. This is a big deal because the current drugs in clinical practice only slow the progression of Alzheimers disease by about 25-30%. It appears younger patients tolerate these drugs better because they have a lower amyloid burden. The initial read-out of date from this Phase 3 trial is expected in 12 months.

So big Pharma is shifting from treatment to prevention with promising looking drugs in the pipeline. If the initial read-out from the Trailblazer trial is positive as is expected this will be a catalyst for the Cogstate SP. Using these drugs for prevention massively increases the TAM. It is possible with a highly effective and safe drug like Trontinemab to have a once a year treatment, almost like having a vaccine, to flush out all the amyloid from your CNS. All of this presents a big opportunity for Cogstate. Their sophisticated and sensitive cognitive testing is well set up for the many pre-symptomatic trials that will follow as big Pharma move into the opportunity. But perhaps even bigger for Cogstate is the all end user cognitive testing that each of us will be doing on our phones to see if it is time to start another course of Trontinemab and go for another brain rinse!

21

mushroompanda
Added 2 months ago

Thanks for the tag @Shapeshifter. I haven't watched the second Investor Insights video - probably something I should get around to!

Some nice tidbits in your notes, especially around Roche's Trontinemab and the Lilly's TRAILBLAZER-ALZ 3 trial. My view on CGS winning the Trontinemab trials have cooled significantly. Given the start dates, I expected the contract wins to have been announced during the AGM update at the latest had they won. However Brad hasn't really changed his narrative around expecting more Phase 3 wins, so they mightn't have been in that specific race in the first place.

On a separate note, the AGM presentation did mention that the Cogstate x Clinical Ink partnership secured a preferred vendor selection with a new top 10 (by revenue) big pharma company. From Brad's social media interactions, and my own bit of LLM-ing - there's a good chance it could be Novo Nordisk.

be9af54e7b14dd458f1da4207efb19ddc63395.pnga7ce4da6df4c26738a0b0ff6ac1502f27bee1d.png


Initial read outs for Novo's EVOKE and EVOKE+ trials are expected at the CTAD conference in early December. A positive readout might be a positive for CGS on two fronts:

  1. If Novo Nordisk is the new customer, then the potential for follow on trials (e.g. combination or with a pre-symtomatic cohort) could follow on quickly with Cogstate in the prime postion to win them.
  2. Eli Lilly, Cogstate's largest customer, also has GLP-1 drugs. It may encourage them to start their own trials.

22

Shapeshifter
Added 2 months ago

Sounds like a Hail Mary from Noro Nordisk. They have failed to protect its GLP-1 patent in the US and their SP has been punished as a result. Personally I find the GLP-1 agonists to have limited efficacy for weight loss in the real world even factoring in cost and availability of the drug. Clearly a fishing expedition from Novo Nordisk and while Cogstate can ride the tailwinds of increasing CNS research spend (second to oncology I think Brad said) they do better when a trial has a positive outcome as this creates further work. This is perhaps one weakness of the Cogstate business model. Their fortunes are somewhat tied to the fortunes of the trial outcomes.

18