Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
If they knew Traumakine had failed they would have to have told the market. Matti was pulled from the trials a while back now, so this has been in the making for more than a day.
That said, I’ve been wondering all year why they focused Hibiscus on Covid patients and not just “regular” ARDS where they were sure of the science. Yes, Covid does cause ARDS but it’s just so unusual in its mode of action and we learn new things all the time. Given that we’ve had one Traumakine trial fail already (due to steroids) and REMAP-CAP hasn’t helped further the cause, I think I would have played it safer. But i hope i’m wrong and Hibiscus is a master stroke.
Whatever happens with Traumakine I’m staying invested. Bex has always been my primary motivation.
Coming up to 10 weeks since the last update, share price flat-lined and now Goldmans accumulating if Laplom’s right. Feels like something has to break soon.
Maija has tweeted a couple of times this month, once to position Bex for a conference next year and once to show the samples they’re analysing in the lab (looks like different doses and frequencies on the samples). So all sounds good there too and analysis was clearly ongoing at start of month. Data adds value to any deal so surely they’d wait for both dosing and biomarker analyses? Hence not convinced this is Bex related.
Hibiscus first patient in was back in August, so it’s possible that they’ve got the initial patients now too. But it’s a double blind trial so no way results will be known ahead of time.
Ideally you’d want both sets of data for a buyout too.
So whilst instinct says something’s brewing, it also feels a bit early for anything major. But who knows… very odd!
The flat-line is odd, but volume is low too so I’m not sure what to make of it.
I’d be quite surprised if there was a wholesale buy-out, especially as Maija is so heavily involved in the Bex programme and the key data isn’t too far off.
What wouldn’t surprise me is if Markku is negotiating a deal for Traumakine pending the interim Hibiscus results. I’ve thought for a while that the company is so focused on the Bex programme that they really need a partner to take Traumakine forward. That would certainly deliver the elusive SSV and fund Bex development too.
But at the end of the day we’re all just guessing!
This from a poster on another board shows how important Maija’s work on biomarkers could be, and why we should be patient and wait for it to conclude…
"As more biomarkers are identified, they have the potential to enhance the research and development process of new medicines by providing new ways to measure disease activity. Biomarkers can also help measure the impact of medicines being studied and can significantly shorten the time required to show that a new medicine is safe and effective."
The traditional way that drugs get approved is through data on Clinical Outcomes. This data can take a long time to collate and leaves patients having to wait longer for treatments to be approved. An example of Clinical Outcomes would be things like tumour shrinking in cancer and other indicators that make up the Overall Response Rate to a drug.
In recent years the FDA has acknowledged that there need to be accelerated pathways so that patients with high unmet treatment needs are not left waiting for years for treatments that could help to be approved.
So pending data on Clinical Outcomes drugs can be granted Accelerated Approval on the basis of Surrogate Endpoints. This is where the biomarker data comes into play because it can be used as a surrogate for efficacy or used as a way to grant Accelerated Approval for patients with the right biomarkers.
"For a serious disease or condition where there is a signifcant unmet need, like cancer, the FDA may allow for the use of a surrogate endpoint to demonstrate the effect of a medicine. A surrogate endpoint is a marker—such as a biomarker or other measure—that is expected to predict, but is not itself a measure of clinical benefit, and can thus be substituted for a clinical endpoint"
"Between 2010 and 2012, the FDA approved 45 percent of new drugs on the basis of a surrogate endpoint."
Yes, lots to come Q4.
It will be really interesting to see what they have to say on the soluble Clever-1 half life question. Markku positioned it as the biggest barrier to a commercial deal a few months ago. If they have the dosing sorted then that will be really good news.
However, the biomarkers / immunological phenotype question is looking like another key piece in the jigsaw. I've been puzzled for a while as to why Bex has such a different response rate across the cohorts without any real explanation. Also, colorectal cancer seemed to be good initially, then dropped off - why?
I don't profess to being a medical scientist, but what if it isn't actually the Clever-1 cancer type that is the main driver of response rates, but the immunological phenotype of the patient. From an immunological perspective we could have had all sorts of patients in the expanded cohorts as they were (I believe) selected on traditional cancer type lines only... and that could have randomised the results.
So if I'm right, Maija's biomarker analysis is absolutely critical to patient selection in pivotal trials. And ideally it will show consistency of response rates across all the cohorts once the biomarkers are factored in. Then we may have a drug that works for all Clever-1 cancers, albeit just for those patients with certain immunological characteristics!
The work Maija’s doing is now critical. If she can identify the biomarkers that determines responders in the key cohorts (and ideally corresponding in the cohorts with lower response rates) then we’re set.
We have data from 140 or so patients now so that’s a lot to crunch through. But if there’s a pattern, there’s a good chance it will be statistically significant.
Then who knows - Breakthrough Therapy approval for last line patients could be possible in parallel with pivotal trials.
The multiple partners strategy is music to my ears - they’re really going for maximising Bex potential.
I’m intrigued as to how they’re going to fund it…
Maybe the price for gaining access to the extended market Bex gives to checkpoint inhibitors is for the major Pharmas (with the CIs) to fund the trials. We would need a bit of extra cash from the markets to keep everything else going but we’d keep 100% of the downstream revenues. Assuming Bex does what we believe then that would be a master stroke!
This is peanuts in the context of the family holdings. And Maija has been positive on Twitter since - she’s a scientist not a con artist!
It’s interesting that the reason to take a deal early is to reduce personal risk and the only way to do that is to sell a good chunk when the deal is done (as it’s still just as likely to fail).
Imagine what people would say if we did a deal and all our board / founders promptly sold a chunk…
They couldn’t could they?
It’s far more likely that they would sell the business if there was any doubt in their minds.
Whatever anyone’s preference is for a deal, I think the crunch time is Q4 for , not now. The data Faron need ahead of the first pivotal trials is (I believe) the same as the partners want.
So it makes sense to run both options in parallel for the moment.
I don’t believe the strategy has changed at all.
Markku was very clear months ago that partners wanted more data on the half-life (soluble Clever-1 effect) which was discovered less than 12 months ago. We can’t now blame him for not striking a deal when that data hasn’t been published yet.
If they can isolate the key bio-markers that determine whether patients will respond during this period, then that will add to the value of any deal too. Hence why Maija et al are working feverishly on it.
Hopefully we’ll get some answers when the next set of data is published, likely mid-Sept. But imo talk of ‘no deal’ is premature until they have the data they need.
I actually think that right now this discussion is more valid for Traumakine. We know far more about its potential and a deal ought to be possible. Whether it’s better to do it now or after Hibiscus interim is an interesting question too.
If I was CEO I wouldn’t want a deal until I knew as much about the potential as possible as I could only negotiate based on what we know now.
Ph2 is open label and data keeps getting stronger, so limited risk there imo.
The big decision therefore comes when we need to commit to a pivotal trial, especially if it would need significantly diluting funds.
I don’t think we’re there yet.
Really helpful Heikkinen - thank you!
For what it’s worth I’m also happy waiting on any deal. The chance of failure is just the same whether we have a partner with us or not. So really it’s about whether we want to trade long term potential for short term gain.
I only hold five individual small cap stocks like Faron in my portfolio and I’m not relying on them for my financial security. So i intend to run any winners as far as they will go. Given that the risk of failure is the same no matter if/when we do a deal, I’d personally rather wait as long as possible, or even go it alone.
But I do appreciate that others have different investment strategies and can see why some would favour an early deal. That’s fine by me.
Ultimately Markku has more riding on the success of Faron than us, and his family are right at the centre of the Bex programme. I’ve met him a couple of times and I’m happy to trust his judgement.
But please DYOR.
Indeed - Price at any raise is likely to be 10% or so below 30 day average. So Markku would want sp to raise over the next few weeks.
Hence I'm pretty sure that they would release Bex data beforehand, and that might i) resolve the soluble Clever-1 half life question (that partners are waiting for...), ii) open up more cancer types, as well as iii) being the precursor to the pivotal trials that the RNS this morning says should start in Q4 (last corporate presentation had recruitment starting in H1 22). The latter also means that the associated FDA meeting will be happening soon.
With all of this going on, I'm confident that Marrku would engineer the associated news flow so that the sp will be higher than this going into any raise.
Progress is amazing when it’s laid out like that.
But you’re right, the key question now is how to fund it. Phase 3 trials and new earlier stage trials means costs are going to be higher next year too.
If he follows the pattern from Feb, this will be the start of the news flow over a short period, probably culminating in the Bex data release. All of which will raise the 31 day average share price ready for the raise.
A US listing is a possible alternative I guess. But we shouldn’t discount a deal on T or Bex either.
One way or another Markku will have a plan by now, so what he says (or won’t say) could be interesting.
Hopefully just the start of the news flow after the summer break!
As others have said, we are overdue a Bex update too. My guess is that it will be at week 16 (as we missed week 8), just in time for the Proactive Investors slot. It's also St. Ledger Day on the 11th and you know the old adage... so Sax, if you wouldn't mind posting a blistering attack on Cancer research and how long it takes to get drugs to market at 6am on Monday 13th, then I'm sure we'll be off to the races :)