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I’ve watched it through now too and the other thing that really caught my eye was the significantly increased focus on combination treatments with checkpoint inhibitors (CIs). It seems that clearing soluble Clever-1 from the plasma (the relatively new discovery) could have a major impact on CI efficacy.
The example given was with Keytruda, and statistical projections showing that Bex could potentially double the responding patient group. The potential value is obvious - Keytruda is huge, and it’s just one of the big CIs!
It also made me think that Markku may now be aiming for multiple partner deals based on combinations with different CIs.
The first trial involving a PD-1 inhibitor in the Bex Clinical Summary Plan is slated to start later this year. Same time as Matins Part III...
I wonder what deal(s) Markku has in mind...
Yeah. Opening an Insta account doesn’t make you an influencer on day 1. It just gives you the platform. Same with Nasdaq. Let’s see how they use it.
Completely agree Sax.
Also, Markku is a scientist first but he’s also a shrewd CEO.
The news releases earlier this year raised the price for the raise so we (and he/his family/Timo) weren’t diluted too much. He wasn’t playing us.
The current drop is not his fault and is no problem to me (or II investors) as long as either the price at next raise is higher than the last or he lands a big deal beforehand.
Most of us here are playing the long game like Markku and the IIs so we should just ignore short term weakness. Let traders guess the ups and downs and make their quick wins (and normally undisclosed losses) - it’s a market after all.
Markku doesn’t have traders in mind when he’s formulating his market strategy. So we shouldn’t be surprised if there are news gaps and short term s.p. weaknesses like this. Trade them or ignore them.
I have been invested here for nearly two years now. It’s the biggest holding in my portfolio and I still add occasionally but I haven’t sold a single share. I’ve met Markku on more than one occasion and I trust both him and (so far at least) the science. Like Sax, I believe this is a major Pharma in the making. But science takes time.
According to the Jan presentation all we’re due on Clevegen this quarter is the Summary Part 1 results.
What we do know is that potential partners were worried about the half life of the drug and that the recent discovery of the effect of soluble Clever-1 is the likely answer. Hence the increased dosing frequency in Part 2 is critical and they may be waiting for evidence that they’re right.
Anyway, all of these new discoveries are increasing the size of the prize so I’m happy to be patient and let the science play out.
A bit further to go yet, but that’s mainly because the prize is getting bigger and surely none of us want Markku to sell us short.
Hibiscus is funded at least to interims in Q3 so why do a deal before that?
We also know more data is needed for a Clevegen deal - also due Q3 too by my reckoning.
Can Markku get a good enough deal on Traumakine to go it alone for a while on Clevegen? That’s the big question in my mind.
Short term news is interesting but not relevant to my investment case (unless it’s bad of course!).
For long term UK investors there is one big disadvantage of switching as AIM investments give inheritance tax exemption after a couple of years.
Outside of that, there may be short term discrepancies in relative share price but they will always even out in the end. It’s the same company either way.
Great catch. I’d noticed the China connection to LOAC but not the Chinese version on the website.
On the broader science question.... My daughter is a first year studying Med Science at uni and she’s just done an essay on the link between the microbiota and autism.
It’s part of a core module, not elective. This is mainstream science now, just not commercialised yet!
Completely agree with you Sax.
I don’t post much but I said as much towards end of Jan...
“ The next couple of weeks will be interesting. Two pieces of news in a week have raised the share price and we learned yesterday that we need more data before Partners will sign for Clevegen. So imo Markku will either raise money in short order or he has more good news up his sleeve in the next month or so which will push us to new (MCap) highs first.”
It’s no surprise to me.
I agree, it looks like he has IIs lined up.
The only alternative imo would be a Traumakine deal with enough up front to fund Clevegen until its full value is recognised. But it looks like he’s also holding out on Traumakine for full value beyond Covid / ARDS.
I’m more than happy to wait - I have a 3-5 year investment horizon so short term share price movements are largely irrelevant to me.
In terms of MCap at c. £200m we’re not too far off all time high. I think in 2018 before the corticosteroid issue hit Traumakine, the MCap was c. £240m. Lots of dilution in between means we can’t use the share price as a valid comparison.
So once Hibiscus is properly under way we could reasonably think that we could get back to that £240m level on Traumakine alone.
Add in Clevegen and Haematokine and you wouldn’t argue at a doubling from here to get to reasonable value. But the market can be irrational for long periods of time, especially in tucked away corners like FARN.
The next couple of weeks will be interesting. Two pieces of news in a week have raised the share price and we learned yesterday that we need more data before Partners will sign for Clevegen. So imo Markku will either raise money in short order or he has more good news up his sleeve in the next month or so which will push us to new (MCap) highs first.
Slightly separately, did anyone pick up in Markku’s words at around 51:30 yesterday? “We believe this is not just a master regulator of immunity, it is THE master regulator of immunity”. If what Markku believes is true, especially with the newly discovered role of soluble Clever-1 in cancer metastasis then his view of Clevegen having “multi-blockbuster” potential is no understatement. It would dwarf even Keytruda!
Fun ride indeed.
Don’t forget that for well over a year now the main focus for Faron has been Clevegen. They have been opportunistic with Traumakine, hoping not to have to invest too much in it to move it forward. That includes Hibiscus being investigator initiated. They are too small a company to fight hard on two fronts.
This time last year the mcap was £110-115m largely on the back of Clevegen. Traumakine hadn’t had its Covid resurrection at that point and so there was little value ascribed to it.
Today we have fallen below that mcap for the first time, despite Clevegen being significantly further advanced and Hibiscus at least being on the Horizon row.
You can make make what you want of that comparison but I personally doubt there’s much further to fall as a result.
We know news is due on Clevegen in this quarter. They will already have the data on the first four cohorts and if there was bad news they would have had to issue an RNS.
So my guess is that Markku is aggregating the data and discussing with partners. If he can get the deal he wants this quarter then fantastic, otherwise IMO he’ll issue a positive RNS with all the data to raise the share price closely followed by a well organised fundraise (similar to the last one) to take us to the point where he has the data to do the deal.
Despite the frustration of many on this board, I can see no point in issuing an RNS on Clevegen before he’s got (the right) one of those options lined up unless he has to for regulatory reasons. That’s because any significant gap would likely lead to a share price drift from wherever the news takes us, which in turn would increase dilution in a fundraise.
All conjecture of course.
Sax - HNY. Markku’s view a year or so ago was that it would be far better to go for a single partner for Clevegen across all cohorts. Not sure if he meant by geography or a global mega-deal (I didn’t ask). I can’t see any reason why he would have changed his mind but a year is a long time.
I’m still holding all my shares so I’m not one of Long’s ‘clever ones’! But then again, I’m a long term investor, not a trader.
4D Pharma to Host Virtual KOL Event Reviewing New Data Presented at the Society for Immunotherapy of Cancer Annual Meeting 2020 from Live Biotherapeutic MRx0518 Clinical Programs
Leeds, UK, November 5, 2020, - 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) - a novel class of drug derived from the microbiome, today announces that it will host a virtual Key Opinion Leader (KOL) event to review data presented from two ongoing clinical trials of MRx0518, the Company's lead immuno-oncology single strain Live Biotherapeutic, as both a neoadjuvant monotherapy and combination therapy in patients refractory to checkpoint inhibitors at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2020. The event will take place on Wednesday, November 11, 2020 at 1:00pm GMT (8:00am ET).
The event will feature presentations from 4D pharma management and KOLs, Dr Mark P Lythgoe, Academic Clinical Fellow in Medical Oncology and Pharmacist at Imperial College London, and Dr Shubham Pant, Associate Professor Department of Investigational Cancer Therapeutics and Department of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center.
A live webcast of the event will be available on the Reports and Presentations section of the 4D Pharma website at www.4dpharmaplc.com. To access the call, please dial 1-877-270-2148 (United States) or 1-412-902-6510 (international) and reference the 4D pharma conference call to join. A replay of the webcast and accompanying slides will be available on the 4D pharma website following the event.
About 4D pharma
Founded in February 2014, 4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease.? 4D has developed a proprietary platform, MicroRx®, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism.
4D pharma's Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut.?The Company has six clinical programmes, namely a Phase I/II study of MRx0518 in combination with KEYTRUDA (pembrolizumab) in solid tumours, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumours, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, a Phase II study of MRx-4DP0004 in patients hospitalised with COVID-19, and Blautix® in Irritable Bowel Syndrome (IBS) which has completed a successful Phase II trial. Preclinical-stage programmes include candidates for CNS disease such as Parkinson's disease and other neurodegenerative conditions. The Company has a research collaboration with MSD, a tradename of Merck & Co., Inc., Kenilwor
I'm in the same place - FARN is by far my biggest holding.
I didn't sell or buy any shares this morning but I did close out my spread bet first thing and re-opened it just after the RNS. So I'm in the same long position again, it just saved me a few grand!
TURKU, FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company, today announces that the first results from the World Health Organization's (WHO) Solidarity trial have been made available as a preprint at medRxiv1 while under review for publication in a medical journal. The results show that subcutaneous interferon (IFN) beta-1a was found to be safe, but ineffective to reduce overall mortality in hospitalized patients with COVID-19.
The WHO's intent-to-treat analysis compared 1412 patients who received IFN beta-1a and 2050 control subjects not receiving IFN beta-1a. The use of corticosteroids was 50% across the study. Overall in-hospital mortality (the primary endpoint) was 12.9% in the IFN beta-1a group and 11% in the control group, RR 1.16 (95% CI, 0.96 - 1.39, NS). The WHO reports that patients mainly received subcutaneous IFN beta-1a (Rebif, Merck KGaA). At the time of the data-cut for this analysis, Traumakine, the Company's intravenous (iv) formulation of IFN beta-1a, became available very late in the observation period and it is the Company's understanding it had seldom been used. The WHO has not been able to verify how many patients received Traumakine at the time of this analysis. About half of the patients receiving IFN beta-1a also received concomitant corticosteroids.
Dr. Markku Jalkanen, Faron's CEO, said: "These first results from the Solidarity Trial are disappointing, given the need for new therapeutics to support the global response to COVID-19. They do support our long held view that IFN beta-1a is likely to be ineffective when given subcutaneously. The science behind Traumakine and its potential to prevent multi-organ failure, through the upregulation of the key endothelial enzyme CD73, is compelling and we continue to believe that an intravenous formulation of IFN beta-1a is what patients need, to strengthen the body's own IFN beta signalling - the first line of defence against viral infection - and provide optimal exposure to the lung vasculature2.
"Compared to subcutaneous IFN beta-1a, the same amount of intravenous IFN beta-1a achieves over 150x higher peak concentration in the lung vasculature without higher systemic exposure3, which we believe makes this method of administration highly effective and safe. We will continue to pursue the science behind this."
Traumakine continues to be investigated in the ongoing global REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) trial, which is evaluating potential treatments for community-acquired pneumonia, including in COVID-19 patients, and is currently ongoing across more than 200 sites and 19 countries.
Faron is also supporting a US trial to investigate the potential of Traumakine to treat COVID-19. HIBISCUS (Human Interferon Beta In Severe CoronavirUS), an investigator initiated study at Harvard Medical School's Beth Israel Deaconess Medical Cent
Thanks Sax, great post.
I mentioned this a couple of days ago but the biggest Clevegen news was tucked away a bit in the RNS, probably low key until the formal update.
It’s also on Page 13 of the interims presentation...
1) Matins ‘adaptive design enabling pivotal data generation’ is the sub-header and the context for this
2) For the first time we have four cancer cohorts for expansion into Part 3 (Confirmatory) of the trial - i.e. pivotal!
3) Part 3 starts Q4 2020 on the timeline.
Imagine the share price impact of having those four cancer cohorts in a pivotal stage 3 trial this year...!
And potentially more as they don’t have enough data on the other five cohorts yet.