$0.016
Opened: 02-May-2024
Shares Held at Open: 18,820,000
What does TRI do?
Trivarx (ASX:TRI) is an AI-driven mental health technology company seeking to commercialise objective measures to aid in the early detection and screening of mental health conditions, such as depression.
What is the macro theme?
We expect technology to play an increasingly important role in mental health care - FDA approvals for medtech algorithms have ramped up dramatically in the last few years. But there are few algorithms for the mental health space. Billions of dollars are being invested in mental health technology companies and startups, and AI is one of the hottest investment thematics right now.
Our Big Bet for TRI
“TRI re-rates to a $250M plus market cap on successful clinical trial results for screening one or more mental health disorders and/or is acquired for multiples of our Initial Entry Price”
NOTE: our “Big Bet” is what we HOPE the ultimate success scenario looks like for this particular Investment over the long term (3+ years). There is a lot of work to be done, many risks involved - just some of which we list in our TRI Investment memo. Success will require a significant amount of luck. There is no guarantee that our Big Bet will ever come true.
Why did we invest in TRI?
1. Screening for mental health issues from sleep data
novel solution to a serious problem. Current methods to screen for mental health are subjective and inaccurate, resulting in patients not receiving the right treatment. TRI is using AI to analyse sleep data to provide objective, accurate screening for mental health issues.
2. Genuine AI (Artificial Intelligence) exposure
TRI didn’t just start working with AI once it became a popular investment thematic in recent months. TRI has a Head of AI, Dr Massimiliano Grassi, who has been doing AI for psychiatry for at least 6 years. TRI’s algorithm has advanced to Phase 2 trials and is getting better as time passes and more data is collected.
3. ~$11M market cap - undervalued and unloved Medtech?
like our successful Investment in Oneview, our view is that TRI is undervalued at ~$11M considering the 9 years of investment into its tech & with a Phase 2 trial being run. We think this is a great entry after years of hard work with the right team to take TRI forward now in place.
4. Imminent Phase 2 clinical trial results
400 patients sleep data is being screened for depression using TRI. IF the trial result is positive, it could open the door to US FDA regulatory approvals and potentially even training the AI algorithm to screen for other types of mental health issues too. The final results are expected in the next couple of months. We think they will be a catalyst for TRI’s share price.
5. Path to FDA approval
TRI has engaged with the FDA and the De Novo pathway was defined by the regulator, a type of FDA approval which is generally longer and more rigorous but reserved for genuinely new medical devices, which we think TRI’s algorithm is.
6. USA based story and market
TRI has a US-based tech team and is going for the lucrative US healthcare market - which is the huge, clearly trodden pathway for big exits in biotech/medtech.
7. Near term revenue opportunities (Stager) - US$15BN market
Commercial roll-out of TRI’s sleep staging software for sleep clinics - commercialisation is underway with licensing agreements and partnerships anticipated 2024. TRI’s novel products are aimed at sleep research organisations in the US, targeting the US$15 billion sleep medicine market.
8. Proven new management team with key backers
recently appointed board and management team with significant success in US and global healthcare markets, including founding directors/financiers of Race Oncology ($600m+ market cap 2021) and ResApp Health, which Pfizer ended up taking over for ~$180M in 2022.
9. Long term technical team retained (AI experts and human brain experts)
Neurosurgeon Dr Defillo and AI specialist Dr Grassi are the brains behind TRI’s tech - they’ve been involved together since 2019 and both bring a special skill set that we think will drive TRI’s success.
10. Major shareholder is Fidelity Investments
one of the largest fund managers in the U.S, is the #1 shareholder in TRI with a ~10% holding in the company.
11. Potential to screen for other psychiatric disorders
if it turns out that sleep data CAN successfully be analysed by its AI to screen for depression, it is possible that the AI can be trained to screen for OTHER mental health issues too.
12. Potential to integrate TRI’s tech into wearables
TRI’s tech may potentially be integrated into wearables like a Fitbit, Apple Watch or Oura Ring that all track simplified sleep data. That’s a big commercial opportunity in our eyes.
What do we expect TRI to deliver?
Objective #1: Complete Phase 2 clinical trial, release results
TRI is currently conducting a Phase 2 trial in the US on its algorithm for detecting current Major Depressive Episode (cMDE). Final results are expected in the June quarter (before July 1st 2024).
Milestones
Phase 2 clinical trial results
Potential additional clinical validation studies
Objective #2: Regulatory approval - FDA De Novo application
TRI will be engaging with the US health regulator (FDA) to bring its product to market. This involves an De Novo application - which would classify its product as “low-risk” and therefore help speed up the approvals process and get TRI’s product to market quicker.
Milestones
2nd FDA Pre-Submission Meeting
FDA De Novo Application submission
Outcome of FDA De Novo Application
Objective #3: Appoint MD/CEO & outline commercialisation strategy
We want TRI to appoint a Managing Director or CEO with the right skills and experience to take TRI’s product into the market. After that we want to see the company sign commercialisation deals. TRI is currently undertaking an executive search for the role.
Milestones
CEO search starts
CEO appointed
Licensing deal #1 - Stager software
Licensing deal #2 - AI depression screening algorithm
Objective #4: Complete Pivotal Study
Today we are adding a new objective to the TRI Investment Memo. Now that it has completed its Phase 2 trial and published the results, the company will look to complete a Pivotal Study.
We had not yet added it as an objective as it was conditioned on the data collected by the company, however it appears that this Pivotal study will be the best way forward for the company to achieve FDA approval.
Milestones
Complete Pivotal Study Design
Appoint CRO for Pivotal Study
IRB Approval for Pivotal Study
Commence Pivotal Trial
Interim Results
Complete Recruitment
Final Results
What could go wrong?
Regulatory risk
It is possible that health regulators do not approve a new screening product like TRI’s. The regulator could require additional data, or reject the application outright. TRI has previously failed with a “Breakthrough” FDA designation and despite taking a more streamlined approach to regulatory approval - this approval is not guaranteed. An adverse outcome from the regulator could hurt the TRI share price.
Competition risk
AI is accelerating at a significant rate - new market entrants could make TRI’s product for depression screening redundant.
Clinical trial risk
Clinical trial outcomes are never certain - TRI might not be able to generate results good enough for the regulator to approve the product. Clinical trials, even low cost ones, require capital in order to be conducted. A clinical validation study, which TRI may also have to complete could cost additional money.
Funding/dilution risk
Small caps often need to raise cash to fund their growth. TRI is not generating any revenue and may need to raise capital, potentially at a discount. Capital raises may dilute existing holders.
Market risk
Broader market sentiment can get worse and speculative stocks as a whole trade lower, taking TRI’s share price with it. Alternatively, there could be further sector specific pain ahead. For example, the biotech sector sells down.
What is our investment plan?
Our Investment Plan for TRI is to hold on to a majority of our position to see the company execute on its business strategy over the next two to three years.
If the company’s share price materially re-rates in the medium term due to the results of the Phase 2 clinical trial results, a commercialisation deal, a macro triggering event or any other unknown reason, we may look to sell up to ~20% of our holding. See our general hold policy for more details.
Disclosure: Disclosure: S3 Consortium Pty Ltd (the Company) and Associated Entities own 18,820,000 TRI shares at the time of publishing this article. The Company has been engaged by TRI to share our commentary on the progress of our Investment in TRI over time. 14,000,000 shares are subject to shareholder approval.
TRI announces smartwatch and wearables screening for mental health issues.
Nov 7, 2024
Nov 7, 2024 |
15 min
They’ve done it. TrivarX (ASX: TRI) has just announced success in the first step for screening for mental health disorders using ‘wearable’ technology.
TRI’s Phase 2 Clinical Trial Results are in…
Jul 30, 2024
Jul 30, 2024 |
13 min
Our AI mental health Investment, Trivarx (ASX: TRI) just published the results of the much anticipated Phase 2 clinical trial.
Screening for mental health issues from sleep data using AI - TRI Phase 2 trial results imminent
Jul 10, 2024
Jul 10, 2024 |
14 min
Our Investment Trivarix (ASX: TRI) has just announced completion of their Phase 2 trial …and the trial results are “imminent”.
Our New Portfolio Addition is ASX: TRI
May 2, 2024
May 2, 2024 |
25 min
Today we are announcing our third new Investment for the year. This one is in the medtech / biotech / artificial intelligence (AI) space. Three themes that we are very interested in. One of our best ever Investments was an “undervalued and unloved MedTech” called Oneview Healthcare back in 2021.
TRI appoints US healthcare executive to board
Sep 26, 2024
Sep 26, 2024 |
1 min
This week our AI mental health Investment TrivarX Lim (ASX: TRI) appointed John H. Mathias II as a Non-Executive Director.
TrivarX Requests Pre-Submission Meeting with US FDA
Sep 24, 2024
Sep 24, 2024 |
2 min
Today, our AI mental health Investment TrivarX (ASX: TRI) announced that it has requested a pre-submission meeting with the US FDA to finalise the protocol for a pivotal clinical trial of its AI-driven algorithm MEB-001.
TRI with Significant Update on their Phase 2 Clinical Trial
Jun 21, 2024
Jun 21, 2024 |
2 min
Yesterday, our mental health technology Investment TrivarX Limited (ASX: TRI) has provided a significant update on its Phase 2 clinical trial (SAMDE study) for the validation of its proprietary AI-backed algorithm, MEB-001.
TRI Webinar Today
May 24, 2024
May 24, 2024 |
37.4 seconds
Today, our mental health technology Investment, Trivarx (ASX: TRI) will be holding an investor webinar at 11:00 AM AEST (9:00 AM AWST).
Reflections on 2024: Markets, Moves, and Milestones
Dec 22, 2024
Dec 22, 2024 |
12 min
Well, that’s pretty much it for the year. Another bearish year for the small end of the ASX. But at least the market managed to string together a few bright patches this year. Most notably during October and November.
A Quiet, but Green Week in the ASX
Nov 30, 2024
Nov 30, 2024 |
18 min
It was another quiet-ish week across much of the small cap markets. The smaller end of the market where we operate appears to be in a holding pattern of sorts.
Riding the Bull and Bear Cycles
Oct 5, 2024
Oct 5, 2024 |
19 min
Everyone's a “genius” in a small cap bull market. At least that is what it felt like between November of 2020 and June of 2022. All IPO’s oversubscribed, cap raises were highly competitive and good news was being rewarded with on-market buying. Everything was going up. (Remember things like Afterpay? Lithium at $80,000/t? Gamestop? Shells with a $10M EV? The occasional “50 bagger”?) Since then, it has been MUCH harder to navigate the small cap market during the “bear” winter.
Silver and gold shines again while med-tech companies make moves
Sep 28, 2024
Sep 28, 2024 |
13 min
With the AFL Grand final just around the corner we take a look at how Gold and Silver are shining through.
What is next for the Market?
Aug 3, 2024
Aug 3, 2024 |
14 min
Well, that was a rough week in the markets. Particularly the last two days of trading.
