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Looking like Hemo may still be on track to complete the third run early December, which might enable completion of IND pre-xmas and then 60 days.........holiday break and final logistical preparations............ and (if there are no objections from FDA) into clinical trials Hemo will go.

Micronormous(e)!
GLA

Aside from the Bauer-Auringer (and associates?) sales (possibly including the sales of positions held by their discretionary managed clients, if such clients existed) my other thoughts regarding events of the past year and a half are:

- was the significantly discounted placing at 1.5p deliberately set at such a low level by Vlad in order that Bauer's, Auringer's and their associates remaining shareholdings were significantly impacted in value (possibly to a level below that at which they initially acquired them) and so their ability to profit further from their activities scuppered by Vlad;
- was a significant portion of that placing (which happened pre-invasion) taken up by Russian persons/entities of Russian ownership; whilst the west have sanctions against Russia, likewise their were restrictions imposed in Russia preventing or restricting Russians owning investment in western companies and therefore is one of the consequences of the invasion that it has resulted in some Russian investors having to compulsory sell their shareholdings (is this what we have been seeing at various times since March?)
- the cynic in me at one point thought that Vlad's tweets of progress seemed to be coinciding with every time the price fell below 1.5p (as though he didn't want the price to fall below 1.5p as that would crystallise a loss for some of those that financed him at 1.5p expecting to share in future gains).

Anyone else like to share other possible explanations as I don't believe there have been Mr India's 'many sellers' at all, just several with significant holdings that were taken up in the last placing?

After a few staff changes, Hemo's team of scientists seem to have stabilised and everything now seems set on completing the next stage which is getting the first clinical trial underway.

To me the science is compelling and Hemo will get the fountain flowing soon. Hopefully there will be a proper update for us before year end.

Probably pure coincidence but noted:
Invios, a stem cell therapy company of Vienna, Austria are presenting in London and attending the same conference.

https://www.invios.com/invios-to-present-at-upcoming-industry-and-investor-conferences/

.... and Vlad posted picture of Stefansdom ladder, a few days ago. Not many cell therapy companies in Vienna.

if only some were slien again .....

Having seen the tweet, I joined the discussion live last night catching the end of Panel 4 from GRIP Molecular onwards.

I would strongly recommend a listen to Dr Sandeep Patel of BARDA's DRIVe division and Labeeb Abboud of the Global Health Investment Corporation - Panel 5. JHFH has posted the link below - that relevant section is from 3:58:32 to 4:42:00.

I think this clearly highlights that as Vlad says "these people mean business" and that their goal is to get finance to where it is needed, timely.

Dr Patel noted the strength of (preference for) products which have multiple applications when it comes to allocating financing (isn't that what Hemo has?). He also mentioned the array of businesses that they assist. Mr Abboud represents a not-for-profit organisation that co-invests alongside other investors.

Let's hope it translates into a battle to do a deal with HEMO!

Point very well made JHFH.

However, whilst HEMO history has shown that it is best not to raise our expectations - re: trials efficiency - surely there is a case to be made that given the limited other (only death delaying) treatments available, the UPenn paper which alluded to further testing in combination with/alongside other existing treatments, and the video of the treated 'humanised' mouse (completely clear of AML) in Vlad's last shareholder webinar {that was one of the most important takeaways from that for me} - there will be sufficient candidates 'readily' available when the time comes who will be glad of the opportunity to receive a breakthrough CAR-T therapy which offers a potential AML elimination and CURE, and thus affording HEMO the possibility (in my opinion) of efficient process for its trials; assuming no unexpected difficulties arise from the treatment.

Approaching the 5 year anniversary of listing - 5 October (worth a reflective read):

https://hemogenyx.com/investors/announcements/announcement/2017/Admission-and-First-Day-of-Dealings/

Interesting to note how far out the scientists were in their assessment of IND costs and timescales (and on several occasions since); though in the time that has lapsed the company has become much more substantially developed. Almost there?

If nothing else, the interim report is due by 30 September.

but,
uvm has a BSL-3 Lab facility

https://vermontbiz.com/news/2022/february/06/uvm-study-sheds-light-how-covid-19-variants’-infectivity-and-viral-load-impact

https://www.med.uvm.edu/medicine/immunobiology/bsl3-lab

?!?

Just re-posting my previous research note from 28 July which seems more relevant after this week's RNS; and might the RNS imply that possible has become 'probable'?

"A possible link for trials, Vlad did mention they were looking at adding other hospitals to Penn:

https://www.uhhospitals.org/for-clinicians/articles-and-news/articles/2022/05/new-hematology-chief-and-director-of-the-wesley-center-for-immunotherapy-named-for-uh-seidman

Seems a promising fit, when you see what they are doing/have achieved so far. The fountain is forming."

It's worth looking further beyond this news page of the wesley centre website to see the scope of the trials that they are involved in.

Dr Koen van Besien has something to offer to both parties he is involved with, in the placement of a Hemo CAR-T trial, and perhaps that is why Vlad indicated (a month or so ago) that they were hoping to add a couple of other hospitals (in addition to Penn) to the trials. Now the medical director announcement has been made - have terms for the extended trial been agreed? Just my thoughts.

A little bit of background re: Dr Koen van Besien's contribution/involvement was given in this interview when the first results of CDX were announced in Feb 2018.

https://www.youtube.com/watch?v=3z6IKgPik0s

Definitely worth another listen through; but at 10.00 - 11.00 Vlad makes reference to Dr Koen van Besien's lead in that "he kind of kept telling us that look you really have to look at the AML because the protein that you are targeting on the surface of blood stem cells is also present on the surface of AML cells." At the time Hemo were focussed on CDX as a new biotech for BMT.

Listen again, is there a freudian slip when he initially says that Dr van Besien is 'head of clinical trials' - before correcting himself?

Then at the end 15.25 to the end there is reference to completing pre-clinical trials and pre-IND meeting and that they have already 'written protocol of clinical trials together with Koen van Besien', though at that time Vlad also considered IND application Q2 2019!

Yesterday's RNS informs us that 'he will be actively engaged in refining the protocol for the trials and its implementation'.

Four years on from that interview, CDX is almost ready having undergone further development with Lilly's input, AML is still a target but an alternative CAR-T therapy for that has emerged out of the research - and Dr van Besien is in place to lead the clinical trials.

A possible link for trials, Vlad did mention they were looking at adding other hospitals to Penn:

https://www.uhhospitals.org/for-clinicians/articles-and-news/articles/2022/05/new-hematology-chief-and-director-of-the-wesley-center-for-immunotherapy-named-for-uh-seidman

Seems a promising fit, when you see what they are doing/have achieved so far. The fountain is forming.

Just noting, today is the anniversary of the RNS announcement date of Dr Alan E Walts appointment as board observer.

"The Company entered into a Consulting Agreement with Dr Walts for a 12 month period of service which includes cash compensation and approximately 3,100,000 options."

Will his appointment be extended; will there be an update ?

The below refers to Amgen's BiTE therapy focused on FLT3.

https://www.fiercebiotech.com/biotech/amgen-pauses-flt3-bispecific-trial-resumes-dosing-bcma-study

Not sure what the current status is, but I presume still halted. Do they have a CAR-T therapy as well?

dqhoang, a bit more about Hemo CAR-T for you:

Here is the link to the ASH presentation/paper published December 2021 by UPenn on HEMO CAR-T:

https://ash.confex.com/ash/2021/webprogram/Paper151196.html

I think the following excerpts from it are important for those wanting to understand what HEMO CAR-T is/might prove to be:

“In this context, we sought to expand the existing preclinical CART armamentarium in AML by developing FLT3-specific CART cells and comparing them to our existing gold standard CD123-specific CART cells. Since activating mutations in FLT3 occur commonly in AML, we reasoned that this molecule would serve as an “Achilles heel” in AML immunotherapy.”

“We have developed CART-FLT3 for AML using novel human anti-FLT3 targeting domains and demonstrated preclinical efficacy similar to that of CART-123 in an AML model with substantially lower expression of FLT3 compared to CD123.”

“…..Serial BLI revealed prompt and durable leukemia remissions and survival"

“…..future experiments will explore combinatorial FLT3 inhibition with CART-FLT3. If successful, these experiments will provide a strong rationale for a combination clinical trial in AML where leukemia control by small molecules is followed by a coup-de-grace delivered by CART cells.”

So there is an existing “gold standard” (at UPenn) with which HEMO CAR-T (so far) compares very favourably. This is not just Hemo that are reporting this, when they say 'we' I take it to mean UPenn in collaboration with Hemo.

Hemo theme tune, background music for the new website perhaps:

https://www.youtube.com/watch?v=-b3XTj5G_SA

on the serious side though, one year is a lot of lives that could be saved but everything must be right for that to begin but Vlad won't be wanting to take any longer than it has to.

Remember the Realm of the Last Inch (Solzhenitsyn):
“Now listen to the rule of the last inch. The realm of the last inch. The job is almost finished, the goal almost attained, everything possible seems to have been achieved, every difficulty overcome – and yet the quality is just not there. The work needs more finish, perhaps further research. In that moment of weariness and self-satisfaction, the temptation is greatest to give up, not to strive for the peak of quality. That’s the realm of the last inch – here the work is very, very complex but it’s also particularly valuable because it’s done with the most perfect means. The rule of the last inch is simply this – not to leave it undone. And not to put it off – because otherwise your mind loses touch with that realm. And not to mind how much time you spend on it, because the aim is not to finish the job quickly but to reach perfection.”

Then consider where the immature Hemo was just 3 years ago, it has matured significantly now, at that time they thought IND would be Q2 2019. A lot more was needed but they are getting there now.

And for those concerned about the share price, notwithstanding that there probably only half the shares in issue then, take Vlad's comment at 7m45s to the end of this next clip: 'laughable'. It was over 2p then and the pipeline is significantly broader and more advanced in every aspect now.

https://www.youtube.com/watch?v=UIdBulChg-0

HT,
Samantha Bauer and Craig Auringer (noted as significant shareholders at end 2020) may have sold or it might just be that the new issues of shares through 2021 has taken their holdings below the 3% disclosure threshold.

Part Three:

Apologies, the following is the link to the 180 Life Sciences legal case - the previous one I posted just showed the ownership of Tyche Capital (against who the claim has been raised) as being Bauer.

https://law.justia.com/cases/new-york/other-courts/2021/2021-ny-slip-op-32453-u.html

There is information that can be found in relation to other claims and counter claims and a section in the notes to 180's annual financial statements.

Part Two:
Here are a few other items/thoughts to add to JHFH's:

1. The below link (180 Life Sciences legal case) suggests that relations between Bauer and Feldmann were not as they should be by late 2020, early 2021.

https://www.sec.gov/Archives/edgar/data/1226144/000121390020045677/ea132552-13gbauer_180life.htm

2. Mint Capital Advisers Limited – was a Bahamas company, ownership unknown and incomplete website.

3. The Proposal document with regard to the CLNs noted:
“On 4 September 2020, the Takeover Panel agreed that the Concert Party could be divided into two distinct concert parties ((i) The Sandlers, consisting of: Dr Vladislav Sandler, Alexis Sandler and Anya Levitov, and (ii) The Bonsai Group, consisting of: Daniel Valk, Flascherberg Capital Anstalt, Craig Auringer, Ron Valk, Mark Hawtin, RS Trading Limited and Dr Robin Campbell), neither of which currently hold an aggregate shareholding representing 30 per cent. or more of the voting rights of the Company.“

4. Bonsai Capital Ltd, from which one could presume the ‘Bonsai Group’ portion of the original concert party takes its name was a Bauer/Auringer (and their clients perhaps). Here they are pictured with Vlad at LSE on the date of the main listing.

https://ideamensch.com/ron-bauer/

Flascherberg Capital Anstalt was/is owned by Samantha Bauer.

5. The SEC investigation focuses on US listed companies, would any investigation with regard to Hemogenyx’s shares be the remit of the UK FCA to investigate?

6. It was reported that Bauer’s extradition hearing was to take place today 20 June at Westminster Magistrates Court – perhaps someone with legal background would know where to find an update for us.

7. If anyone has tried to take advantage legally or otherwise, as JHFH surmised hopefully this is now behind us (or nearly behind us), lessons have been learned and Hemo’s true value will be allowed to follow through if/when the science is proven. Perhaps then LTH might learn what has been 'saved'.

8. ….and one final thought from me - in the light of the SEC's claims some of those (hopefully innocent) tweets from the ‘champagne’ days don’t look quite that smart now!

Part One:
On 19 April JHFH shared:

“Side note... Should I share? Should I not? This is in the public domain already....
https://www.sec.gov/files/litigation/complaints/comp-pr2022-61-bauer.pdf
Bottom line is there is no smoke without fire and for the past few years a few of us have smelt ALOT of smoke. Dont let it be a distraction or waste too much time on it but it is worth noting that some of Hemo's (Probably EX) biggest shareholders have been accused of being involved in serious fraud. The accusations include funding companies, taking controlling stakes, taking the money out via loans never to be repaid and written off.
To be clear HEMOGENYX is NOT listed, but there is a very good chance that the kind of behaviour we saw with Mint, the dumping, the non stop tanking of the SP last year, could have been just one more of their scheme.

I am sharing because many people saw the selling and tanking of the SP as a reflection on Vlad and Hemogenyx where to me it has always just been wrong, its completely disjointed from the value of the company and pipeline. We have no evidence to say for certain that these folks tried to take down Hemogenyx for personal gain, but its worth considering.

I repeat however this is NOT negative about Hemo, MANY companies have been taken advantage of, they have been stopped so hopefully IF they were attacking Hemo they will back off and be too busy dealing with their legal woes... It is not good to be associated with this sort of behaviour but if it helps to explain why we are sitting on an mCap of 14mil then I would rather know and if it means that we are now free to recover then its GOOD news.”