Member Info for stu485

Some infamous posters here, are pushing the narrative, non-dilutive financing and significant SP re-rate will materialize at commencement of Hemo’ Car-T phase1 clinical trials and initial data.

They are wrong!

I’ve explained with reference to third party documents why, professional Biotech investors are likely to view de-risking for investment of potential AML treatments as being much further through clinical trial process, than other indications.

“Durability of response.” See previous posts.

(See link below )

A real life Biotech company example to further substantiate my argument.

Small MCap Bio.$135m

Announcement of Commencement phase1, Car-T clinical trial for r/r AML, first patient dosed .

The trial has FDA Fast track designation and the treatment Car design, of Nobel prize winning science.

(Now that’s the type of science to trust, Mr I)

RNS Commencement of clinical trial with first patient dosed, DID NOT move the dial on the company SP !

Big Pharma have NOT yet invested in the companies AML trial operation, now at dose level 2, whereas in the company’s other trials indications,…they have !

Might that suggest a particular risk approach to AML?

Another example, Micro MCap Bio. $14m. same,RNS r/r AML, first patient dosed, result ?

…+3% raise in SP.

I could share more examples but that would be laboring the point i feel now made very clear.

Maybe those same infamous posters can now share previous real life Biotech company Car-T r/r AML examples that substantiate their arguments ? There are many Bio’s conducting such trials, so there must be some? …I won’t hold my breath waiting!

Should you wish to see a positive re-rate in SP then best hope the next RNS is that confirming the 2024 June company announced objective of securing , Non-Dilutive financing.

Ps.

JFH, you might want to get Haywaine back off the bench.

HT, it wasn’t a “filler” you’ll realize in time, just as you did with Prevail.

AIMO

The Rat…Reasoning & Truth.

https://www.clinicaltrials.gov/study/NCT06128044

JfH,

You are not stupid and i know, you know !

In AML “specifically”

- Proof of Safety is of no value.

-Proof of Efficacy is of no value .

……….Until some meaningful Durability is demonstrated.

Professional Biotech inverters know too !

White flag from me, you win.

Goodbye & good luck.

AIMO

JFH,

……“ the same for EVERY new drug”

Well, no it is not!

Read the article I attached, specifically highlighting the uniqueness of AML. Maybe have a word with the editor to explain his error !

A simplified analogy for you;

The roulette wheel of treatment is spun, (day one)

You’ve bet on red, The croupier then covers the wheel up with the “durability” sheet and asks you to return in a year for the outcome.

Apologies for the crude analogy and I truly hope for the patients sake , when at the unveiling it is red !

Professional Biotech investors will know the specific and particular risk and hence my conclusion.

You don’t like this aspect being exposed as it completely screws your flawed argument of why SP should climb at commencement of trials with investments flow.

Non-dilutive financing , will be via other endeavors and not at early stage results of H Car-T for the above reasons.

My opinion , your welcome to yours.

AIMO

Ps…sorry i forgot!😉

2/2

New, Non-Dilutive financing.

In my opinion, it will not come from any result in early clinical trials of H Car-T.

AML’s particular difficulty of relapse, often following patient’s initial complete response to treatment, uniquely moves the de-risking of investment out until meaningful durability can be demonstrated.

Professional Biotech investors will be fully aware of this specific problem.

See attached article with durability described at;

…ONE YEAR post treatment.

https://news.cuanschutz.edu/cancer-center/car-t-cell-therapy-update

I suspect any new Non-Dilutive financing will be achieved through other endeavors.

An observation.

Those who posted the most patronizing argument of investors being “bed wetters” had they any concerns on H Car-T early trial not delivering guaranteed non-dilutive investment, forgot to mention the AML durability/de-risking issue!

Had i a large investment here and were only reliant on their argument, my bed would be made with a permanent plastic top sheet !

See you all again when Non-Dilutive financing RNS drops, maybe even as an investor! Until and unless it does, nothing more from me.

AIMO

The Rat…Reasoning & Truth.

HT’s question.

Why should a non-dilutive funding announcement be due soon?

I’ve proposed that in my opinion,two RNS communications could be announced very soon, and already overdue.

See company RNS 17th June.

The company has detailed its expectations and hopes on both. Why then is it unreasonable to share in that hope and anticipate them both materializing.

Regarding my thoughts on, why soon?

We do have much of the information required to make our own reasonable timeline estimates to the companies stated objectives.

For example.

Regarding the second site and new clinical indication for H Car-T. We know a third party was already engaged to make an assessment in June. We also know if required, FDA approval would be made within 30days of application .

Putting the pieces of available information together, is it unreasonable to consider the second site and new indication news, now overdue…I don’t think so.

Regarding the “diligent efforts” the company has undertaken (now for some time),to achieve Non-dilutive financing to advance its initiatives . Recent company communication of JV potential etc, and ask yourself,how many investor events is it possible to attend without success? Is it unreasonable to consider and combine the information available and arrive at a conclusion as i have…I don’t think so.

For me, the second site and new indication are insignificant, the funding aspect…extremely significant.

AIMO

1/2.

Mri,

Have another read of my first mail, you’ll realize then.

AIMO

Chris,

I’ll pick your first choice plus FDA approval for new indication.

- 2nd site confirmed and named

AIMO

Chris,

What big news on Car-T trials are you expecting?

AIMO

Ping,

Probably best you read again for your full understanding.

Presently your misquoting.

AIMO

The Rat …Reasoning & Truth.

Mr !,

Be careful with your interpretation.I have stated ,what should be expected and not what i know...very different.

What should be expected, if you believe the company's hopes and expectations (all as RNS communications),will actualy materialise.

To answer your question, i can only surmise, presently the market thinks, they won't.

AIMO

The Rat...Reasoning & Truth.

Mr I

I don’t have that detail and i do not offer investment advice.

Have a read of this.

More to follow as requested.

https://news.cuanschutz.edu/cancer-center/car-t-cell-therapy-update

AIMO

The Rat…Reasoning & Truth.

What should we expect?

Well, from the recent company announcements and considering the time now elapsed,…two !

1.FDA approval for the amendment to the clinical protocol to include the new indication, - ALL, alongside full details of the second site facility.

2.Announcement of securing non-dilutive funding to support all the company initiatives.

Personally, the first is of zero value to my assessment.The second however would change it completely. I think both well overdue and should drop very soon.

To those cynics suggesting today’s RNS could be the precursor to a Dilutive raise(Placing) surely not now, given the apparent growing opportunities and companies diligent efforts!

RNS 17th June

1 ”An amendment to the clinical protocol to include pediatric AML is currently under review by third party experts. If approved, the Company will seek to implement the clinical trials for pediatric AML at the newly established clinical site. “

2 “We are diligently pursuing non-dilutive financing options to support these initiatives”

AIMO

The Rat…Reasoning & Truth.

Ps. Reply to Ping request,to follow.

Don’t want to be accused of immediately distracting from todays “Great RNS”.

JFH,

I think best i leave for the weekend, just checking all ok with you ?

Have a nice weekend.

AIMO

JFH,

I’m sorry I didn’t specify a time I might post, I’ll be sure to clock in & out with you next time, that is your job ?

Just please, let the grown up’s debate actual science.

Some might think you’re very keen not to ?

AIMO

HN,

Nope , my comment on Durability of response is not misplaced, and in my view is critical to the ease or otherwise of funding.

Unless or Until it’s established , I suspect non-dilutive funding will be extremely difficult to obtain.

You are though 100% correct in that Phase 1 is to determine safety and MTD. On this we completely agree.

Why some here repeatedly claim funding will not be an issue upon commencement of phase1 trial, i do not understand and yet to see anything of substance to support their Hypothesis.

I would be very interested to read any documents that might support their claim?

With Micky’s request for substance and not just “hype” in mind, attached a link to a current Car-T phase 1 AML trial.

Interesting that the primary outcome time frame is 6 months and the trial 3 years for completion.

I’m not sure many understand the time frames involved as well as you may.

https://clinicaltrials.gov/study/NCT06017258

AIMO

JFH,

You’re trying very hard to deflect the discussion of why posts were removed to that of my return to posting here, it’s very obvious!

I said i would only post upon RNS and request of forum member to comment. You might not like it but both criteria were satisfied.

I mentioned a “little bird” had informed me of the removal of post. Maybe that “little bird” had also asked my comment .

So back to the important topic, why were post removed ?

Could it be that there was no such confirmation of multiple investors awaiting upon positive initial trial data?

Have a nice day, I’m out for the remainder.

AIMO

JFH,

You seem very confused and agitated today.

Firstly,

Post have been removed, as I understand, they were considered “False & Misleading “.

You can try hard as you like to dispute but the fact is, they have been removed.

Secondly,

You’re still not understanding my post.

So just for you and for a final time,…have another read before you pop off back to the congregation.

“State of play?



The reason for SP decline is not due to shorting or some trading conspiracy others would have you believe. They make such claims for a particular reason which will become apparent.


It’s actually and very simply, the risk/reward when viewed by informed Professionals, is unfavourable. Particularly the moving target of resource and costs to conduct the necessary Car-T trials. 

See FP third party paper substantiating the later as true and factual. 



Further funds are required, the company has stated! 



The working hypothesis of some is; 

Funds will support through to preliminary trial results and if favourable, more non-dilutive funding will be easily available. 



I disagree.

Firstly i suspect further funds will be required prior to patient trials AND preliminary results.

I have previously explained the reasons why.



I also disagree with the ease of further non-dilutive funding in the event of favorable “preliminary”results,Why? 



Durability of response! 


The nemesis of Car-T treatments .let me explain.



Let’s assume first patient results are an initial complete response . No doubt some here would quickly pronounce a cure for AML . Well ,… no ! 



It’s not unusual for Car-T treatments to result in a CR , and it’s not unusual for the “Durability” of such a response to be so short lived to be unsuitable even for a potential bridging therapy. 



So, i would not expect knowledgeable professional biotech investors to pile in unless and until, clinically significant durability is proven.



The JFH/Digitt hypothesis of funding and particularly its likely timing, is unreliable as a significant time post initial treatment is required to demonstrate durability.



My last post, why ? 

It’s becoming more apparent to me that some genuine LTH’s are suffering both financially but more importantly mentally.Unfortunately my posts appear to antagonize which is not my intention. 



So I’ve made clear my opinions and shared independent third party papers to substantiate. 

I will not be responding further with the exception of ;



1. I’m proven wrong. 
I would then return only to publicly admit my error. 



2. Upon future RNS with subsequent request by any forum member for my comment.



I will only post again in those circumstances, 100% promise ( not a JFH 100%).”

AIMO

JFH,

How many times do i have to prove you’re wrong before you pop off back to the church of JFH for good?

You’ve taken my criteria for a return to posting here out of context, so to help you, below the full post.

There was indeed an RNS and i was indeed asked to return by a forum member.

Granted , my return post had no comment on the recent RNS as, no need a complete none event, in my view.

…anyway just for you, read and this time, comprehend!

Last Post:

“State of play?



The reason for SP decline is not due to shorting or some trading conspiracy others would have you believe. They make such claims for a particular reason which will become apparent.


It’s actually and very simply, the risk/reward when viewed by informed Professionals, is unfavourable. Particularly the moving target of resource and costs to conduct the necessary Car-T trials. 

See FP third party paper substantiating the later as true and factual. 



Further funds are required, the company has stated! 



The working hypothesis of some is; 

Funds will support through to preliminary trial results and if favourable, more non-dilutive funding will be easily available. 



I disagree.

Firstly i suspect further funds will be required prior to patient trials AND preliminary results.

I have previously explained the reasons why.



I also disagree with the ease of further non-dilutive funding in the event of favorable “preliminary”results,Why? 



Durability of response! 


The nemesis of Car-T treatments .let me explain.



Let’s assume first patient results are an initial complete response . No doubt some here would quickly pronounce a cure for AML . Well ,… no ! 



It’s not unusual for Car-T treatments to result in a CR , and it’s not unusual for the “Durability” of such a response to be so short lived to be unsuitable even for a potential bridging therapy. 



So, i would not expect knowledgeable professional biotech investors to pile in unless and until, clinically significant durability is proven.



The JFH/Digitt hypothesis of funding and particularly its likely timing, is unreliable as a significant time post initial treatment is required to demonstrate durability.



My last post, why ? 

It’s becoming more apparent to me that some genuine LTH’s are suffering both financially but more importantly mentally.Unfortunately my posts appear to antagonize which is not my intention. 



So I’ve made clear my opinions and shared independent third party papers to substantiate. 

I will not be responding further with the exception of ;



1. I’m proven wrong. 
I would then return only to publicly admit my error. 



2. Upon future RNS with subsequent request by any forum member for my comment.



I will only post again in those circumstances, 100% promise ( not a JFH 100% ) and considering the two exceptions above ,

So it’s now clear to all,Micky was correct.

I returned* to counter balance the tirade of patronising criticism,not of his language,but his actual argument .

His arguments were absolutely correct and have been proven so by the actions of those employed to properly arbitrate.

“False & Misleading”

Taking Micky’s recent thoughts into consideration, i have nothing more to say on the subject.

AIMO

*post to follow.

Cons,

Ok. You’re not frustrated and you believe, no posts have been removed.

I’ll leave it there, I suspect others might expose your error.

At this moment in time, i have no need to.

Good night.

AIMO