Member Info for rhubarbmk2

So - be on the look out for the dosing of healthy animals.

They seem to have nailed the pharmacology and efficacy aspects of a submission, so this is a third hurdle to pass.

Personally, I'd also like to see more efficacy data, in a larger number of animals/tumours.

I'd be publishing any of the above, if only in the form of a poster. This would allow any developments to be RNS'd efficiently, and allow momentum to build. If I have one criticism of the excellent work they've done with CLX, and the excellent and scientifically-prolific partner they have chosen, it is that VAL as an outfit underestimates the thirst for scientific news, by the average retail investor.

This gives the impression that VAL are working as an academic science department, rather than a share-holder owned public company, but ironically without the scientific output (201 peer reviewed data and BC201 delays, as examples). It's a shame, as they can do the *hard* part very well, from all the evidence I've seen, so I see it as a personal objective to keep pressing the BOD hard to deliver data, but in a commercially-aware manner. This is a gap that I think needs improvement, but that is better than the converse.

SAR got to about a 200-oddM Mcap at one stage, as excitement built regarding SDC-1801 and the final stages of preclinical tox testing, helped by a couple of HNWI deciding to chip in. Obviously it has fallen for reasons beyond the scope of this post a lot since (regulatory preclinical development issues, which VAL should be wise to try and foresee/avoid), but the fundamentals of a potential great Phase 1 drug should not be underestimated. I'd take 70p a share for a comparable CLX001 price if it gets to Phase 1-ready; never mind £2.36 :-)

Every Phase 1 SPV, to my mind, would be the same, looking at the therapy areas and potential markets available.

I think the above is probably fairly pragmatic feedback for the BOD. No point just continually sticking the knife in, and especially no point with pathetic child-like strops around how the CEO dresses, or looks. Totally debases any form of criticism; at least in my view. Plus it makes the poster look like big willy.

NH;

Any tox. screening, if successful, is a big thumbs up in oncology; especially when you are using peptides, nanocarriers etc.

It is on my to-do list to ask Suzy what platforms they are using for their "initial" screens, as they may vary from applying CLX001 to cells, to actually dosing a healthy rat, with a competent immune system, for example, for around 7 days (very big deal if passed).

We know it isn't toxic to immunocompromised human tumor-bearing mice, but for development, it needs to be dosed for a clinically-relevant period, to healthy animals.

Along with other datasets that are needed for a medical submission, I *think* that VAL will go down what is called an ICH S9 route - "Non-clinical evaluation for anticancer pharmaceuticals", wherein the aim would be to go straight into TNBC patients. It's a slimmer development route, with a quicker way to get to the ultimate Phase 1 submission. They will likely also incorporate some of the S6 guidelines for immunotox. testing, given the peptide aspects.

Essentially, they need (may have already) to work out what the likely dosing schedule would be, clinically. They then need to recapitulate this, probably in two animal species, and demonstrate a level of toxicity, at a given dose. They'll probably dose the complete nanocarried product, at varying doses, and then have an additional group, with the unencapsulated peptide product.

You then extrapolate down the dose. So, for a traditional cancer molecule, you could go into a cancer patient at 10x lower a dose than that which caused "severe toxicity" in 10% of rats (using an example).

That's why bringing a partner on board in the next few months is fairly ideal. They can help scope out the specific dosing schedule within which they'd like to see the data, and partner or buy it when a certain milestone has been reached. The pharmacokinetics will help with this, to see how often it would likely be needed to be dosed in the clinic.

All very exciting IMO.

My understanding is that loads has already been done by a third party with 301, NH. I know they've been working on efficacy models for, probably, well over a year, to find a different approach to the Mode-of-Action.

It's Hokkaido that's going into the lab.

@Porky.

Two events would encourage me to take a position on the BOD.

1. Issuing 40M shares anywhere near 5p, for acquisition purposes, as per your theory. I have to look after my investment, after all.

The lab, as is, can be built and added to, with both personnel and capability, to turnover maybe 3M per year. Could be more, depending on how they play it. On a proportionate scale, I've done this myself, but admittedly probably have more confidence at present than the BOD themselves, in their ability to do this. That will change this year. It's a good time to do it and they have been very cost effective in their approach so far. I like it, and the work will come.

2. There being a plethora of juicy preclinical SPVs, with which I think I might genuinely be able to help, at least from the development side. This would save the Company money.

I still see option 2 as more likely but, as you say, let's agree to see how it pans out.

Never occurred to me Metom.

201 clinical trial was pathetic. It therefore lost such an amount of patent, that the number of partners willing or able to reformulate/patent it became small.

Every SPV will have an initial 18 year patent or so, and about 50X more Companies willing to partner or license it.

...For, mark my words, a shatteringly better financial deal than 201.

Btw; as the self proclaimed "King of Rampers", you were great at ramping lots of folk out of their pension pots, in a Company promoting snake yoghurt that didn't work.

How about ramping a preclinical asset that obliterates human-derived tumours in mice, even allowing some to live out a full life, with a 100% cure (never seen that before).

Because, if you didn't know, we have one of those.

I’m not one for banning, but I am one for sticking to facts and outlining speculation, where it is.

Probably an issue with the poster Porky is that you can counter-argue most things, but then the very same and unabridged arguments are outlined at 6am the next day, with no counter debate. It’s a one-way street.

Even sucking that up, the use of a false-narrative is his posts is so obvious, I’m embarrassed:

“BUT lets assume it’s a VERY positive evaluation, it will still take absolutely years before any form of licensing and VAL need to be able to fund supporting it until it can be licensed” – Porky.

This is absolutely hogwash. Even if an SPV is taken the full 2.5 years to IND (which the majority are now not), it’s categorically not “absolutely years”; even at worst-case scenario.

“A company could progress an SPV to a bigger value inflection point when it has capital available to do so, or alternatively, seek a risk- and resource-sharing partnership to reap more of the commercial benefits” – Bloeme et al., 2023.

https://www.nature.com/articles/d43747-023-00002-6

“What I would say though is that the market has changed, its really tough to get deals for early stage pharma and I suspect this is the real reason why Suzy wants to move more towards a labs based business with regular revenues” – Porky.

“Amgen has signed two big early-stage deals in a matter of days, signalling that antibody-drug conjugates are a priority target in oncology for the firm. Amgen will gain access to Synaffix’s next-generation ADC technologies for one program with the option to exercise exclusive research and commercial licenses for a further four programs at a later date. Announcing the deal on 5 January, Synaffix did not provide details of any upfront payment, but said a deal signing fee, and milestones in the development of four candidates could reach up to $2bn, plus tiered royalties on potential future sales” – all preclinical platforms – Synaffix.com. 5th January 2023.

Is that recent enough?

Big pharma might not like it, but preclinical early-stage deals are back with a bang – sorry to disappoint.

And, btw, Blautix simply didn’t work, so that was years from eventually putting the whole portfolio into the bin, never mind commercialisation. It had a 50% response rate, with nearly 40% with the placebo.

By all means, let’s debate the science of the VAL compounds, but comparing them to a company ramping yoghurt; must do better. The fact they couldn't raise a bean was because they were unlikely to work; not because of the market.

Unfortunately, Metom, you played the April Fool card after midday.

I'll let you look that one up, my old fruit...

"Doing the same things and expecting a different outcome is just plain stupidity".

Now, I don't disagree with everything you say, Porky, but transitioning from a clinical development outfit, to a preclinical discovery outfit (recently endorsed by that Nature article), with the concomitant generation of an in-house trialing facility, is not far from a 180 degree step-change in Pharma, so there's only one thing that's fairly stupid in that assessment, whether you like the new strategy or not.

Plus, this "ramping squad". Where is it? There's literally two exuberant posters, but tens of "like some, not all" posters. Plus, an absolute mince of one-liner de-rampers; almost I'd say, putting you in the majority.

It's not rampers per se who don't like your postings, it's just that very few people can tolerate a very bent bat, IME.

Why not just say "PM and Iceman won't like this, but I want to buy in at 4p", before you make your points, which I often, btw, enjoy reading.

At least that's a tad more honest.

Excellent post Fred.

Multiple chances for inflection. And when your SP is in the gutter, it's not a bad place to be as a speculator, which is really what AIM Biopharma is all about.

Rather buy at 10p, with five chances of success, than buy at a quid with a one-horse bet.

I bought another tranche of shares today; for various reasons, but CLX lead optimisation; re-running tumour efficacy data; and completing a preliminary tox screening protocol, all with a positive outcome, is a big bar in oncology, given the nature if the compounds.

As importantly, this would now be a good juncture to commence formal partnership talks, with a view to the potential partner inputting into the specific endpoints required for handover (e.g. how near IND stage they would want it).

The more VAL do now, the higher the upfront payment will be.

Paramount to this is that they've reached a potential commercial inflection point within a relatively short time of initial assessment, so that bodes well for how quickly they can move with all aspects, when not reliant on a third party. And other compounds could now be even swifter, with the new lab to hand.

To me, the current SP is now officially a steal, but everyone has a different opinion, and this is only mine.

And the last point, if VAL can prove precisely how 301 works and file with that, then that is something that Suzy has managed, but a major pharma hasn't, so I would take my hat off to that.

Oh and 301.

It's the opposite of CLX.

CLX will need the full development tox screen (we know it has efficacy and why).

301 is likely a given, tox-wise, due to 201 similarity, and theoretically suitable for women of child/bearing potential. Until now, it has been like CLX, in that we know it shrinks lesions, and the Japanese will have confirmed that, but they probably didn't specifically know how, so that has needed more efficacy evaluation.

If it makes it into an SPV, formally, and if they get a new patent, then that has a very significant likelihood of being able to get to Phase 1. Could be fast-tracked. I would expect the Japanese may take it if VAL can determine the specific mode-of-action and get a new patent. Too good an opportunity IMO.

Good RNS.

Lot of work in there.

CLX has no initial tox screen issues, so I'll raise my personal valuation of that now. That's significant.

BC201 is a nice surprise, so await the publication/marketing (probably then needs a partner, but would have a long patent and shorter development times, because it's basically 201 and they've already tested it in man).

Barcelona looks a goer.

Lab hasn't messed around.

Fair play.

Metom is right, OB.

It's best to remain incognito on these boards.

I do hope Stella and Cathy buy some shares.

Yours Sincerely,

Kevin Cox

I wish they did too Sooty, if I'm honest. I really do.

If they then came out strongly for a short-to-medium term build strategy; focused recent additional low price raises onto SPV conversion and a new project or two; boldly stated, to put to bed various postings, that they would only countenance a "buy" strategy in the medium-to-longer term, with preliminary capability demonstration; and simply insisted that TX pay any dues or lose exclusivity, then I'd buy another couple of percent, whilst I'm at it.

We'd be building from 20p up, absolute minimum.

But WTFDIK about strategy. Just an observer.

He's right, actually Phimx.

Peptide reformulation and re-patency is simply not a task that any large pharma would have the expertise or will to do, when they can buy a shiny new pre-Phase 1 preclinical asset with a 16 year patent.

On paper, Ken and Patrick have a track record in doing this.

Whether they can raise a bean to do it is obviously largely out to debate, but the hard statement is accurate, at least IME.

Phimx,

We thought we'd at least get some time off, after Porky was caught with his trotters in the misrepresentation till.

Can we not just have a day?

It's like Medusa in here.

There's better short-term opportunities elsewhere, so I'd be looking there. Especially non-pharma. Fill your boots.

Next!

ISO 9001 is a quality management system. Very simple. I have a QMS myself. You can get certified for that one, but it's very quick. GLP is much more laborious, but the work they're doing wouldn't fall (at least initially) under that.

So formalities for that won't be in the critical path. They're probably validating the equipment and growing some cell lines now.

I have to say, they have been really proactive on the lab. No messing about.

Revenue starting this Summer, at this rate, I'd say.

OK Porky.

No point kicking a settled debate. Fair dos for coming back.

Must've been 50 applications to Suzy yesterday from lab technicians wanting in.