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Lilly will manufacture a batch for trials..HEMO do not do manufacturing and it is not something you can put in place quickly. Lilly may have already been working on this in the background if they felt it was a goer...saves time and time is money.
I’m no expert either! But I’ve read a lot so have peace of mind and see past swimming’s lame posts.
Swimming loves to undermine people’s confidence. He loves it. Strange behaviour to try and make investors think there are things wrong with the company he is invested in also thus encouraging sells and dipping his own holding value?
I personally saw zero problems from the RNS which to me limits the chance of failure. In terms of slippage on timescales... Vlad rarely commits to anything anyhow but I’m happy and aware that most things take a long time to execute in pharma. We are in the middle of a pandemic also which has slowed us down re:CDX in particular.
Thanks for the summary, very useful.
#invladwetrust
#patienceiskey
Thanks for the recognition Pingu.
I'm no expert and I don't claim to be, but I stand with you 100% in the Vlad camp!
Amazing things will come from this little pharma, it's clear as day to see. We just need to stick to our guns and before we know it we'll be reaping the rewards.
GLA
Reprobus I like your work. You’ve added more to the BB in one post than swimming has in two and had years. He’s been invested here for ages yet doesn’t trust the company and can’t understand how big pharma work.
Patience here people. Sir Marc Feldmann says we’re in track. I trust him also... more than I trust swimming anyway
Think about what work is involved in preparing for human trials. The drug must be prepared into its final state for production and manufacturing. Who does this? Us or Eli or someone else Eli work with? Which hospitals will be trial the drug at? Do the doctor and nurses need training on dosage? The supply of the drug needs managing - supplying multiple hospitals at some point to trial it with enough patients.
Plenty to do to conclude pre-clinical work and prepare for clinical. Clinical Trial plans go into the IND enabling application to prove the drug is ready to be taken forward so I believe this work is all being completed at this very moment.
I’m quite sure Eli know what they’re doing. Things take time. What else do you expect from Vlad? We will get RNSs at the right time when things are finalised in each area.
You either trust him or you don’t. I’m firmly in the Vlad camp and will be to see HEMO through its key milestones over the next year.
I think the next step for CDX will be the tests on monkeys mentioned last year, as it appears they've been focusing on manufacturability.
That was a sticking point for me too OnTarget. Until someone kindly pointed out that we've already done in vitro and in vivo testing for CDX and the pre-clinical TESTING is what we've been doing for the last couple years w Eli. As I understand it, now remains the IND application to the FDA (about a month to get approval back) and putting a trial plan together which I imagine shouldn't take too long (can be done in that waiting window!)... Eli are old hands at this. All in my understanding... I'm by no means an expert on the process
My bad ontarget, I have somehow got the two statements confused.
1) Progress CDX antibodies for pre-clinical development by December 1st 2020.
2) Advance CAR-T with Penn University towards clinical trials.
Since when does 'pre-clinical development' mean clinical trials?
To be honest I thought pre-clinical development was what they'd been doing for the last 12-18 months, so was a bit surprised to read that.
I have decided to just leave Hemo to take its course at the moment. One day I will log on and hopefully we will have received the news and the price will be to the moon!
Because that specific date wasn't listed in the RNS doesn't mean it isn't factual
Well Swimmy,
I've laid the facts out plane and simple, so if you want to continue with your childish de-ramping then so be it.
26th June hemo announced lupus agreement with Globalco and on 13th July RNSed Eli lilly as the globalco who they have agreement on CDX
Also previously Hemo was working with J&J on lupus model.On 26th June same day hemos rns,J&J announced discontinuation of Phase 3 LOTUS Study(LUPUS)at which point i was convinced Globalco was J&J .13TH july rns was confusing and the confusion perhaps still continues as recent announcements still refer as Globalco and not eli lilly..
Also Eli lilly has 2 covid candidates and they did mention they will add more if available in future.Thier results are due in october.could Hemo been added to lillys possible covid cure?
That leaves Car-T.Hemo trying to expedite this with Pen(probably funded by lilly) leaves me thinking if succesful,hemo could be take over target for lilly ..
Hi everybody, after re-reading yesterday’s RNS and digesting all of the information I have compiled all of the highlights in a format I hope is easy to follow.
* Hemo’s Main Focus’
1) Progress CDX antibodies for clinical trials by December 1st 2020.
2) Advance CAR-T with Penn University through pre-clinical development towards clinical trials.
3) Develop novel treatment for Covid-19
* CDX antibodies
Treatment of AM Leukaemia & conditioning for bone marrow transplants to pre-clinical development.
GlobalCo companies to finalise manufacturability sign licensing agreement by December 1st 2020.
* Disease Modelling Platform Tech (AHC & ApbHc humanised mice)
1) Successfully constricted and tested CAR-T cells for the potential treatment of AM Leukaemia & conditioning for bone marrow transplants. Sponsored research agreement with Penn State announced August 11th 2020 in order to move towards clinical trials.
2) Hoping to develop novel treatment for Covid-19 by developing “neutralising antibodies” which are typically created by the human immune system to neutralise invading viral pathogens.
3) New form of mice (AHC) with 95% human immune system for blood cancers, drug testing & treatments.
4) ‘Immunex’ (owned by Hemo) have developed (ApbHC) mice which have several advantages over other mice.
5) ‘Orgenesis’ paying 10-12% royalties for the use of Hemo’s mice.
6) Colab agreement with ‘Janssen R&D’ (J&J) in hope to discover “novel materials” for treatment of Lupus (SLE).
7) Potential ability to defeat unknown virus’ (“Disease X”) that could break out, similar to Covid-19 and other deadly virus’.
* Hu-PHEC Cell Therapy
Cell replacement product to generate cancer free patient-matched blood stem cells after transplant. Patents approved in US (Feb 2020) & EU (May 2020)
* Autoimmune Diseases
Hemo have entered into a “biological investigation” and “material supply agreement” with ‘Eli Lilly’ in June 2020 in aim to discover “novel materials” to be used for the treatment of Lupus Erythrmayosus and potentially other autoimmune diseases.
* Financials
£3.15m raised from placings in January & June 2020 for Hemo’s drug development program.
£35k raised in H1 2020 in exercises warrants. Loss of £835k in H1 2020 (1st half of financial year).
£83k raised in H1 2020 for sale of humanised mice. Up to $500k drawn by warrants from ‘Orgenesis’ in H1 2029.
GLA