Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Clearly we know that every oncology busines bar none knows about STEM given the ASCO poster and thus everyone knows how much better it is. GC would have sounded out any potential buyers early and would be progressing towards a listing but with one eye on a trade sale.
The real magic of STEM is the near term revenue generating qualities. Within a year the test could be in hospitals earning a 75% gross margin (this is what exact earn). This is really attractive to big pharma. The cancer diagnostics market is forecast to be worth $250bn by 2023 a CAGR of 7% per annum. Breast cancer is currently and forecast to be the biggest contributor to this and is growing with increased prevalence in asia. Test them then sell them the drugs – an absolute no brainer for big pharma earning big money on both.
Most of the big pharmas have significant cancer capacity be it drugs or diagnostics.
Roche – is a major player in diagnostics of cancers and also drugs with $26bn revenue in 2018 coming from them. They have at least 2 breast cancers drugs which I have posted before about. Indeed, their strongest growth drugs include Perjeta for breast cancer.
Abbott – is a big player in diagnostics with 13% of revenue coming from testing for cancer. So clearly the sales and distribution teams are in place and relationships exist so adding STEM makes a lot of sense.
Pfizer – from what I can find, Pfizer are not that hot in diagnostics but what piqued my interest, much like Roche, is the sales link for a drug they have called ibrance which is used to prevent the reoccurrence of breast cancer exactly what STEM tests for. Test the patient and then sell them a drug. Cancer drugs contribute 15% of revenue and include other breast cancer drugs including talzenna.
Novartis – like Pfizer, not big in diagnostics but have big growth aspirations for a breast cancer drug called kisqali.
Thermo fisher – massive in testing much like abbott, strong in cancer, addition of STEM would make sense.
Eli Lilly – an outside bet as their cancer division is weak on sales apart from their breast cancer offering which is going well.
There are at least 7 others including GE and some lesser known diagnostic businesses that should be interested.
We do not know how much competition there was for Oncotype DX from other bidders or whether the 1,000 employees put other buyers off as it would be much easier to integrate a start up into the existing sales/distribution channels or whether a 15 year old test was deemed to be at the end of its lifespan or did some just know about STEM as an early mover.
For all of the above anything under $1bn is peanuts especially given the gross margin potential and crucially what they can then sell off the back of it.
In my opinion, I am more than happy to wait 12 months for additional value as major milestones are hit especially the 6 month target of getting approval for the test (FDA is not needed). I can wait but can a big pharma wait and then spend more?
funny how this years ASCO coincided with the STEM demerger plan.
breast cancer is the biggest market within the biggest market and STEM got a poster (itself a major achievement) at the highest profile oncology conference. It is abundantly clear to me that at the event, GC/KS were overwhelmed by the response pre and post event. STEM is very much on the to buy list of all major pharma testing companies. Now we have 5 big pharma after our blockbusters from a team who have a PR machine that is unrivalled on AIM. Remember companies are made on partnering with a big pharma who normally then swallow them. we have 5 after us...
Should be remembered that Oncotype DX is about 15 years old so is well established in the marketplace. However in the last few years we have seen Mammaprint eat into that share especially in Europe. HC Wainwright have put a conservative £280m MC on stemprinter and so based on what they would have done by way of DCF and knowledge in the marketplace that is where the discussion should be. They would not just throw a number out. However, in a big pharma valuing it someone like Roche would think along the lines of how it works with their 2 blockbuster breast cancer drugs so can offer a full service whilst Exact will be mindful of a potential huge competitor hitting the market in 2021 so would buy either to make their service better and/or to prevent a competitor stealing their market. At $280m paid today we would get a nice dividend and money into the phase 2 trials or if a buyer does not come forward then stemprinter can progress and would be worth substantially more in 12 months time with distribution deals and all that comes with actually starting to generate revenue. The analyst wrote 'we anticipate that StemPrintER uptake could be significantly faster than that of Oncotype DX once introduced'. The plan was for Q1 2021 for STEM to go commercial in Italy.
The whole STEM thing moved really quickly. I don't think even GC/Kunwar thought it was as good as it is. The study was done by Royal Marsden and European Centre for Oncology, who are titans in oncology, and i think the strength of this connection enabled TILS to get ASCO to showcase its poster (this is not an actual poster but a presentation - medical terms). May this year was the first results from stem then a few weeks later an intention to de-merge and then further results. This all happened over 4 weeks. I just cannot see how from the worlds biggest oncology conference, a test that usurps the best in the world by a mind boggling amount has not gained huge buyer interest in a world where pharma is gearing up for a major bull market. $300m to enter a market or cement your position in a market where the top test turned operates on a 75% gross margin is ludicrous. have faith in kunwar and GC (they stand to gain the most financially which from a PI perspective is what you want) they are experienced in M&A.
TILS have patents on oral and nasal formulation which is important as some diseases will be easier to target/respond better if given in different manners. Either way this is far superior to the high toxicity and high cost attributed to intravenous delivery. The IP has been developed with Dr Howard Weiner, sits on the TILs board, who runs the Ann Romney Center at Harvard and is one of the top 5 minds on MS globally ie when he speaks people listen.
Focussing on the two sectors that TILS have identified in conjunction with big pharma. These phase 2 trials start in July 2020 with results in Q2 2021.
Crohns – our CDA partner on this indication have said they want to Phase II orally administered Foralumab– worth $3.8bn in 2016 and anticipated to be $4.7bn by 2025 – major players in the treatment include Abbvie, Pfizer, J&J, Allergan.
MS – our CDA partner have said they want to Phase II nasally administered Foralumab - worth $20.83bn in 2019 and the drugs are high cost and are lifelong as there is no cure. Novartis, Sanofi, Roche, Merck, Pfizer. There have been major corporate moves in this sector in recent years – Receptos invented Ozanimod which was approved in March 2020 for MS and Receptos were taken over by Celgene for $7.2bn in 2015 (Celgene then were taken over by Bristol Myers Squibb for $74bn largest ever TO in pharma). This shows that big pharma is willing to take a long view and acquire early if the early trials are positive.
It has also been discovered that Foralumab could work in the Alzheimers market (£17.7bn per annum and a growth rate of 12.3% annual.
TILS amongst their 256 patents have a patent for the oral/nasal administration of Foralumab which is transformational for the sector.
"The issuance of this first-ever patent on formulation for oral administration of mAbs is a very exciting and timely development, as it facilitates a transformational avenue for immunotherapies" commented Dr. Howard L. Weiner, Chairman of Tiziana's Scientific Advisory Board
I have written a short piece on why foralumab in conjunction with our delivery technology and patent is the 'crown jewel' in TILS, our current value will be truly dwarfed by Foralumab.
Foralumab is the only fully human (as opposed to humanised which comes from mice thus making it easier to get approved on and means that humans produce less immune response to it so it works better) anti CD3 (attaches to t cells as part of the immune system) monoclonal antibody in clinical development anywhere in the world. Historically Anti CD3 have led to greater toxicities which has been a problem, TILS have the solution and this has been through a safety trial with no issues) It has potential to be used in autoimmune and inflammatory diseases including Crohns, MS, type 1 diabetes ($25bn annual market), Inflammatory bowel disease ($15.9bn annual market), psoriasis and arthritis ($8.6bn annual market), CV19.
GC calls foralumab the tiziana ‘crown jewel’ as it targets the largest markets in pharma. GC talks of Roche and Biogene having blockbuster drugs in the MS field. Foralumab is a monoclonal antibody a class of drugs which has been shown to be the greatest revenue generator in pharma full stop. 7 of the top 10 biggest revenue generators in pharma in 2019 were monoclonal antibodies and monoclonal antibodies in 2019 generated $122bn in turnover and by 2024 this is estimated to exceed $200bn a year. These drugs are given intravenously ie they get put into the body in a non targeted way but TILS have a patent and the technology to deliver orally, nasally and in lung which reduces toxicity and is more targeted. Apply that tech to a $100bn+ market a year and you have a major, major breakthrough with TILS leading it alongside what GC reckons are multi billon dollar a year turnovers for our targets if successful.
The phase 2 Crohns work starts in Q2 and what has been overlooked from the previous interviews on it is that following the phase 1 Crohns results, TILS were approached by many big pharma who were very excited by the results. We know that Paraxel (who also work with Synairgen) were one of the NDA’s that TILs have (4 more to find out). Paraxel effectively act as a middleman to move drugs through the process and are huge at it with a global presence.
Crohns is a US market worth $9.4bn (2017 )and annual growth rate of 3%-4.3% CAGR and 3m US patients a year). The NDA (now Paraxel) dictated that they want to see oral administration which is what is about to happen. Ahead of the Phase 2, a study has been conducted at Harvard medical that shows that oral administration of antibodies works so Kunwar sees phase 2 as 'derisked'. This is humongous. We have interim data from this study in Q4 21 and final data Q2 22 so say Q2 2021 so if those results prove what has already been concluded in the small study that this works that is when TILs get just one of their blockbuster drugs into a completely different league.
We all know how important and innovative oral administration is so if the results are good enough then it is easy to see how the Crohn’s market opens up big time. You only need to capture a small % of a $9.4bn market to see Crohns as one of the major inflection points for TILS.
Alzheimers, Crohns, liver cancer, MS, covid, breast cancer – big, big markets and growing markets and TILS are well advanced in all of them with crucial IP/patents. Big pharma would do well to start making contact now – oh wait they have….
great link - the regeneron mab needs (FDA) to be delivered by IV - imagine if our patents for our delivery methods can pass testing and regeneron buy for that IP. I think it is fair to say we have just found another NDA candidate and the posters idea of Dr Graham being placed in this role as part of a partnership could well be true.
newflow strong over next few weeks and the wider picture is showing immense opportunity.
for the SH who have bene here since last year if you recall how TILS were invited to do a poster at ASCO (only the best get invited) they showcased a result in STEM that was 45% better than the market leader. We now have two presentations that have seemingly come after the anecdotal brazil results. read into it what you will and with the doctor saying how 'excited' he is by the brazil results you know we are onto something. although brazil is about covid, covid is actually the sideshow to proving up the delivery method and strength of our IP.
TILs are not going after small market drugs, they are going after the elephants - crohns, cancers, alzheimers - every market is experiencing major compounded annual growth rates and the diseases are becoming more prevalent in asia so we have the US and asian pharmas interested in what we do.
lots of newsflow combined with a low free float means this will move like crazy when we main market and brazil results by end of the month. remember we rose 40% on the anticipation of the main market move RNs in the summer.
remember these guys know how to do PR unlike many AIM co's
try and find a drug or major pharma who is not likely to benefit from oral, nasal or lung administration technology. Therefore if the methods work and data suggest they do, then try and work out who would not be in the game to acquire TILS!
My first stab at a CDA with big pharma is with Biogen a £45bn US Pharma. I believe that our Alzheimers work has been closely followed by Biogen who are working on 5 drugs targeting Alzheimers (phase 1 to 3 with one drug filed with FDA) are the world’s leading pharma on Alzheimers. They work with monoclonal antibodies same as our Foralumab and have worked with Dr Howard Weiner, lead at TILS on Alzheimers in the past and also based in Massachusetts same as Dr Weiner at Harvard. Interestingly, in 2003, in honour of Weiner’s 60th birthday and in recognition of his research in MS and other neurologic diseases, a gift of $3.3M was made to Harvard Medical School by Biogen to establish the Howard L. Weiner chair in neuroscience at Harvard. Food for thought at least - shows our guys are extremely well regarded in the industry and know everybody so when the data shows good results the big guys will know about it and TILS will be no more!!!! this will happen quickly and competively
TILS are seemingly very good at maximising the opportunities at the conferences. With 2 this week lets look back and see what has happened when they have previously presented. STEM came from nowhere to deliver a mind blowing 45% improvement on the market leader at the 2020 ASCO. Looking at it all in the round, this seemed to be the stimulus for a lot of approaches. H2 2020 we had a CAR-T RNS and one on Alzheimers and a raft of swift patent applications. We then got Paraxel and the good doctor suddenly all excited about 5 NDA’s To say I am excited about 2021 is an understatement.
With only 9% freefloat, it seems we may have passed the AIM short selling games and moving into a different era.
The phase 2 Crohns work starts in Q2 and what has been overlooked from the previous interviews on it is that following the phase 1 Crohns results, TILS were approached by many big pharma who were very excited by the results. We know that Paraxel (who also work with Synairgen) were one of the NDA’s that TILs have (4 more to find out). Paraxel effectively act as a middleman to move drugs through the process and are huge at it with a global presence.
Crohns is a US market worth $9.4bn (2017 )and annual growth rate of 3%-4.3% CAGR and 3m US patients a year). The NDA (now Paraxel) dictated that they want to see oral administration which is what is about to happen. Ahead of the Phase 2, a study has been conducted at Harvard medical that shows that oral administration of antibodies works so Kunwar sees phase 2 as 'derisked'. This is humongous. We have interim data from this study in Q4 21 and final data Q2 22 so say Q2 2021 so if those results prove what has already been concluded in the small study that this works that is when TILs get just one of their blockbuster drugs into a completely different league.
We all know how important and innovative oral administration is so if the results are good enough then it is easy to see how the Crohn’s market opens up big time. You only need to capture a small % of a $9.4bn market to see Crohns as one of the major inflection points for TILS.
fine to repost.
i have more research that i will share later.
TILS have patents on oral and nasal formulation which is important as some diseases will be easier to target/respond better if given in different manners. Either way this is far superior to the high toxicity and high cost attributed to intravenous delivery. The IP has been developed with Dr Howard Weiner, sits on the TILs board, who runs the Ann Romney Center at Harvard and is one of the top 5 minds on MS globally ie when he speaks people listen.
Focussing on the two sectors that TILS have identified in conjunction with big pharma. These phase 2 trials start in July 2020 with results in Q2 2021.
Crohns – our CDA partner on this indication have said they want to Phase II orally administered Foralumab– worth $3.8bn in 2016 and anticipated to be $4.7bn by 2025 – major players in the treatment include Abbvie, Pfizer, J&J, Allergan.
MS – our CDA partner have said they want to Phase II nasally administered Foralumab - worth $20.83bn in 2019 and the drugs are high cost and are lifelong as there is no cure. Novartis, Sanofi, Roche, Merck, Pfizer. There have been major corporate moves in this sector in recent years – Receptos invented Ozanimod which was approved in March 2020 for MS and Receptos were taken over by Celgene for $7.2bn in 2015 (Celgene then were taken over by Bristol Myers Squibb for $74bn largest ever TO in pharma). This shows that big pharma is willing to take a long view and acquire early if the early trials are positive.
It has also been discovered that Foralumab could work in the Alzheimers market (£17.7bn per annum and a growth rate of 12.3% annual.
TILS amongst their 256 patents have a patent for the oral/nasal administration of Foralumab which is transformational for the sector.
"The issuance of this first-ever patent on formulation for oral administration of mAbs is a very exciting and timely development, as it facilitates a transformational avenue for immunotherapies" commented Dr. Howard L. Weiner, Chairman of Tiziana's Scientific Advisory Board
I have written a short piece on why foralumab in conjunction with our delivery technology and patent is the 'crown jewel' in TILS, our current value will be truly dwarfed by Foralumab.
Foralumab is the only fully human (as opposed to humanised which comes from mice thus making it easier to get approved on and means that humans produce less immune response to it so it works better) anti CD3 (attaches to t cells as part of the immune system) monoclonal antibody in clinical development anywhere in the world. Historically Anti CD3 have led to greater toxicities which has been a problem, TILS have the solution and this has been through a safety trial with no issues) It has potential to be used in autoimmune and inflammatory diseases including Crohns, MS, type 1 diabetes ($25bn annual market), Inflammatory bowel disease ($15.9bn annual market), psoriasis and arthritis ($8.6bn annual market), CV19.
GC calls foralumab the tiziana ‘crown jewel’ as it targets the largest markets in pharma. GC talks of Roche and Biogene having blockbuster drugs in the MS field. Foralumab is a monoclonal antibody a class of drugs which has been shown to be the greatest revenue generator in pharma full stop. 7 of the top 10 biggest revenue generators in pharma in 2019 were monoclonal antibodies and monoclonal antibodies in 2019 generated $122bn in turnover and by 2024 this is estimated to exceed $200bn a year. These drugs are given intravenously ie they get put into the body in a non targeted way but TILS have a patent and the technology to deliver orally, nasally and in lung which reduces toxicity and is more targeted. Apply that tech to a $100bn+ market a year and you have a major, major breakthrough with TILS leading it alongside what GC reckons are multi billon dollar a year turnovers for our targets if successful.
watching the latest CRUX video was really enlightening. The whole PR bugbear seems to be being addressed which is the first time I have really felt confident that FM is making the right moves. If he can pull off an eskom deal, change the PR to green/clean tech along with an increasing (not too crazy as to impact VRFB) and stable V price then 2021 will be massive. add in the mini grid, expansion in production, BE deals and the wider VRFB market such as IES going great guns I would hope to see a very varied and strong newsflow.