The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.
Main point from the proactive article on TILS
TILS recently submitted two abstracts which summarised these validation studies, which were selected for presentation at the American Society of Clinical Oncology's 2020 Virtual Conference held in June. This is an exceptional achievement given ASCO’s selectivity. Furthermore, the conclusions shown were that StemPrintER provided a superior and more refined tool compared to the standard Oncotype DX.
In terms of getting STEM to market it requires the following:
- A validation study for a laboratory developed test – this should take 6 months which aligns with being able to go to market in early 2021 – as suggested by GC
- Take up by practitioners but by virtue of the current advocates who STEM have been working with you (major oncology centres, leading figures in oncology and leading hospitals – hence the ASCO abstract and poster) would think this backing alongside a test providing 40% better accuracy, oncologists would need little in the way of persuasion to move
- Getting the distribution channels lined up
The commercial prospects for StemPrintER look very buoyant given the size of the unmet need, the projected addressable market, as well as its superiority to a market standard, if a validation study confirms this promise.
Some key facts
2m new cases of breast cancer a year globally, 300,000 in the US.
It is important to understand that the exact sciences $2.8bn purchase of genomic healthcare also included a colon and prostate test. However, on a revenue basis in 2018, the breast cancer division contributed 89% of revenue to genomic healthcare so as a comparative figure, we can crudely say that the breast cancer division was worth $2.5bn of the purchase price.
Exact think the breast cancer diagnostic market is worth $1bn globally a year with 50% of that in the US. There is more than enough space for STEM, Oncotype DX and the other players to co-exist and for STEM to get a large slice of this growing market.
Exact are definitely driving their new asset as expecting $1.2bn profit this year against $900m in 2019. This is a 75% gross profit margin. If as I crudely put the breast cancer side is worth 90% of this then Exact should be extremely worried at how within a short timeframe their revenue could be shot to pieces by a new player – think yahoo getting usurped by Google – yes it still exists but not in any way, sense or shape as a competitor.
From an investor perspective lest say that STEM lists at 10% of the value of $2.8bn so $280m, we would need to wait 6-12 months for major milestones to be hit ie the retrospective test and distribution channels being sorted for the test to be then worth as a minimum $2.5bn but with a major upside from there. so 10 bagger on STEM/Accustem and then a 12 month view of 3 bags for TILS but if one of the 5 CDA's goes formal and becomes known to the market then that figure moves significantly as does any postive news on the phase 2 trials.
with the pr and business accumen of GC and KS i would expect news on the crohns and MS phase 2 trials commencing to drop straight after the cut off date to retain the momentum in TILS as inevitably there will be some sort of drop as the more trader style investors flog off TILS (wrongly in my opinion).
It would not take much for TILS to more than double by year end and STEM to see even greater rises say 5 x and if the global covid second wave comes as expected then the covid value (which i see as negligible right now) suddenly becomes more acute as our delivery method is key and valuable.
i cannot see a better and safer place for my money right now than in pharma and tils in particular.
STEM is an abolsute godsend. if it lists at $280m then a ten bag takes it to $2.8bn. if it lists at $100m then a 10 bag gives us a paltry $1bn. Either way as a shareholder it is a great result. This is a potential 12 month view as well.
I am now keener that STEM is listed and let grow rather than an industry sale, the rewards will be far greater for not much more patience.
say STEM lists for $280m, as shareholders we get this value but if you then hold for 6-12 months then realistically this could 10 bag. just to get to the value of Exact sciences purchase and would still be 40% better. The rationale for this share is so so strong.
and what is crucial on AIM is constant PR - I reckon there have been 10 interviews over the last 4 months across bloomberg, proactive etc. that is phenomenal.
spot on JR the fact that GC owns 40% of the shares and the others are funds and long term HNW should give great comfort that the 9% free float which is tightly held in any event will be an ever diminishing pool of available shares. The money is following a team who know pharma and know how to sell pharma and are backing a team that is targeting the big markets ie crohns, Ms, alzheimers, cancers. every now and then you find a great story on Aim, this is unrivalled right now. compare it to the PI favourite AVCT (i do hold) who do not have IND and have only got some initial studies in mice. TILs is Phase 1 on 2 blockbusters, have major patents, 5 CDA's and STEM. All investors should backing TILS whether you trade or invest. The only downside i see is of course that both indications fail at phase II, stem fails a retrospective test that is in effect already passed and all cda's walk. either way you have a year of potential gains to accrue before then.
I could be accused of ramping but there are so many value inflection points ahead it is almost comical we are still at such a low level but makes the purchase of shares now an absolute no brainer. For sure TILs could see a drop in value post STEM demerger but given how PR savvy Kunwar and GC are I would expect them to fight this as TILS will still be their main focus. This could be confirmation of commencement of 2 phase 2 trails (crohns and MS), a CDA going formal, new patent etc etc Christ even things like our Alzhemers idea came from nowhere as did STEM so no idea what else the boys have lined up.
Main point from the proactive article on TILS
TILS recently submitted two abstracts which summarised these validation studies, which were selected for presentation at the American Society of Clinical Oncology's 2020 Virtual Conference held in June. This is an exceptional achievement given ASCO’s selectivity. Furthermore, the conclusions shown were that StemPrintER provided a superior and more refined tool compared to the standard Oncotype DX.
In terms of getting STEM to market it requires the following:
- A validation study for a laboratory developed test – this should take 6 months which aligns with being able to go to market in early 2021 – as suggested by GC
- Take up by practitioners but by virtue of the current advocates who STEM have been working with you (major oncology centres, leading figures in oncology and leading hospitals – hence the ASCO abstract and poster) would think this backing alongside a test providing 40% better accuracy, oncologists would need little in the way of persuasion to move
- Getting the distribution channels lined up
The commercial prospects for StemPrintER look very buoyant given the size of the unmet need, the projected addressable market, as well as its superiority to a market standard, if a validation study confirms this promise.
Some key facts
2m new cases of breast cancer a year globally, 300,000 in the US.
It is important to understand that the exact sciences $2.8bn purchase of genomic healthcare also included a colon and prostate test. However, on a revenue basis in 2018, the breast cancer division contributed 89% of revenue to genomic healthcare so as a comparative figure, we can crudely say that the breast cancer division was worth $2.5bn of the purchase price.
Exact think the breast cancer diagnostic market is worth $1bn globally a year with 50% of that in the US. There is more than enough space for STEM, Oncotype DX and the other players to co-exist and for STEM to get a large slice of this growing market.
Exact are definitely driving their new asset as expecting $1.2bn profit this year against $900m in 2019. This is a 75% gross profit margin. If as I crudely put the breast cancer side is worth 90% of this then Exact should be extremely worried at how within a short timeframe their revenue could be shot to pieces by a new player – think yahoo getting usurped by Google – yes it still exists but not in any way, sense or shape as a competitor.
From an investor perspective lest say that STEM lists at 10% of the value of $2.8bn so $280m, we would need to wait 6-12 months for major milestones to be hit ie the retrospective test and distribution channels being sorted for the test to be then worth as a minimum $2.5bn but with a major upside from there. so 10 bagger on STEM/Accustem and then a 12 month view of 3 bags for TILS but if one of the 5 CDA's goes formal and becomes known to the market then that figure moves significantly as does any postive news on the phase 2 trials.
if TILS snare a 'big' name then the share price will explode as pharma is shaping up for a serious bull market over next few years according to GC. given kunwar is talking to 5 big pharma i would suggest the chances are very high indeed!!! the names who are big in our crohsn and Ms fields include Pfizer, Abbvie, Sanofi, Roche, Merck - literally the biggest names out there.
remember analysts thinks TILS is $25 a share excluding STEM!!!!
the wall street analyst put $25 a share on TILS excluding STEM.
With STEM having no value on the balance sheet according to GC this share really is double bubble.
With today's RNS on CAR-T it adds another surprise to the TILS stable. The Alzheimers RNs came out of the blue and STEM came out of the blue and now this. It seems that ASCO was the spark that got TILS 5 CDA's with big pharma and certainly seems like alot is going on in the background whereby big pharma is dictating what they want to see by way of Phase II targets and should the results be positive, they will acquire either outright or an equity stake to move forward to Phase 3 and approval. TILS is a great mix whereby we have the M&A experience and skills of GC and the medical excellence of Kunwar. Lots of near term major value adding inflection points.
Not exactly rocket science as to why the nasdaq is up. STEMprintER will have a specialist genomics focussed management team who can extract full value from it ie if not sold they can work in getting the distribution channels right and move it from a $280m initial valuation (anticipated) to one that starts to push onto the $bn.
The wall street analyst 12 month target of $25 excludes any value from the STEM spin off. Read that again. big, big upside here. buy the shares, wait a year come back and see bags.
a nice idea davey and with 5 under CDA it could be a competitive landscape. What is pleasing about TILS is that it is advanced with its trials heading into phase 2 which says alot about the potential for its treatments.
We know that TILS have 5 cda's with big pharma. who are they and what are they for?
Formalulab will have 1 cda for crohns disease and 1 for Ms - these could be from any of 15 of so behemoths in the market as both diseases have big names already supplying into the market. I doubt TILS will have cda's with several big pharma per indication unless a partnership approach between two big companies which is increasingly a way in which pahram is working to share costs and risk/reward.
It does seem that ASCo opened the door to CDA's so milciclib has at least one for cancer - liver - which would indicate an asian pharma group or Bayer who two drugs milcliclib effectively went head to head on in the trial.
I doubt STEM has one but Covid may or we may have some CDA's over the patent for oral and nasal itself and not neccessarily on our drugs. lots to speculate on but certainly what we can guess at is a minute part of what is currently happening in TILS which has a really exciting future.
Once AGM has past - damp squib as always so don't get your hopes up - we will then get news on phase 2 trials starting on crohns and Ms and the sale/listing of STEM. major value inflection points ahead
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 and although STEM is today's hot topic and rightly so, the value it brings can 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 and nasally 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.
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 20202 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.
Finger in the air although it does say in the note that they consider it conservative but a good starting position for negotiations
don't know but HC Wainwright 'conservatively' put $280m on it based upon 10% of the genomic sale but stemprinter is then 40-50% more accurate. genomic (now exact sciences) has been around for 15 years so well entrenched so any pharma would want a big discount to reflect that (apart from exact sciences - who i don't think can take any risk on this and need the technology more than anyone). I think it is prudent for this board to be conservative as expectations can get out of hand so say $280m and TILS get a major funding boost for their blockbusters and shareholders get a special dividend that way we all win nicely . Don't forget how advanced the blockbusters are - the crohns disease one has already been shown to work in humans in a small study. I know nothing but 5 big pharmas know what TILS have and like it alot. that to me is a great reason to invest. STEM is an outrageous bonus whether it lists or gets sold.
From HC Wainwright..
And as a publicly-listed business, it is worth around 10% of the value of Genomic Health, the nearest competitor, HC Wainwright’s Raghuram Selvaraju reckons.
On that basis then its value should be in the region of US$280mln, which compares with Tiziana’s current market capitalisation of US$226mln.
“In our view, StemPrintER could begin trading as a separate entity well before the end of this year,” said Selvaraju in a note repeating his ‘buy’ recommendation and US$25 a share price target.
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. We are now 6 weeks on and although a listing will take say to November to happen fully as a time consuming process, a sale can be much swifter and i truly think that TILS were shocked by the results so were pushed to demerge it by the level of buyer interest. Timing for a sale i would say october/november also but could be sooner as really there is not alot to sell and no complex staff etc it is merely IP around the algorithm. offers will move fast though but completion much later. 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 over that last year 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. keep buying TILS and patience will be rewarded.