Member Info for Scinv_temp

No Bermuda. Wrong again. These other drugs are intravenous infusion as you already said. Going from that to subcutaneous is a HUGE step forward in terms of convenience, time and patient acceptance.

The only difference in scancell's case is that more of it stays in the skin where there are far more dendritic cells, than going all the way down to the muscle. From the patient's or the practitioner's point of view, there is almost no difference at all in terms of time or convenience.

What they are trying to do is see if iSCIB1+ works better when a higher concentration of dendritic cells are targeted. They need it to be non-trivially better than scib1 (they said "a lot better" by the way), because that's the one that has the longer patent life.

Did Lindy suggest the explanation you gave?

They have a new cohort Bermuda. How would they pay for that? Given the slipped timelines, and the new cohort, I am not surprised by the timing.

I think I agree with Boski too, they might have gotten a conditional agreement for the new raise, "get the new deal first".

In my view, they should just be more honest about everything. A good plan has value, fog has negative value. They had plenty of opportunity to tell investors they plan a new cohort and explain why they need it.

Hopefully the new CEO will change that for you, but what we have seen so far is that he is distancing himself from what happened before (has not provided a single comment apart from the placing rns). What I'd be hoping to see in the next period is a clear description of a good plan moving forward.

In my view

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There are not the only ones focused on hla a2 patients because that is where the T cell epitopes were identified from patients that spontaneusly recovered, decades ago.

They only scenario where this finishes quickly is if it is a straight no. So I would not worry about a month delay (not talking about more than that), IF you assume that SC would notify a no as soon as it happens.

And yes, this often leads to minor adjustments for the contract and if we are talking about a large company, it can take several, routine but time consuming, approvals to finalise.

Not talking about the financial terms obviously, but details. For example stuff that may come up during the evaluation that may have been conditionally agreed upon. I am not saying anything unusual. It's just that I know that final sign off after an evaluation and going into the option part can take a month or so and there is nothing wrong with that.

*thing

Having participated in many deals of this kind, it is one think to negotiate the heads of terms and basic structure and another to sign the contract. The major parts are agreed upfront (and that is the most difficult and essential) but then the final draft and signing the contract takes time.

Also note that contract negotiation periods often extent beyond evaluation periods.

Even if SC knows by December that the deal will move forward (and they most likely will if the outcome is positive), large companies need multiple approvals to sign the option contract and that bureaucracy takes time in all of them and none of them would allow an announcement before the contract is signed. So assuming the company is going to promptly inform investors if they receive a no from them (I won't bother with providing an opinion on that), no news is good news in this case.

A clear case of long synairgid

What's wrong about giving an interim report at a highlight stage that was offered to them?

*important

And more importantly, why???

I don't have the answer, but I do think it is an portant question.

Moderna and the rest of them make their announcements in the context of important events, on top of whatever events they have the financial means to organise. Not just rns and proactive. Scancell had several great opportunities to provide updates, they gave them a very exclusive stage back in April at AACR that they could have used to keep everyone engaged and set the scenery for additional announcements. They basically insulted the organisers by presenting data from 6 months before and as a result none of the specialist media covered them. At the festival of biologics less than 2 months ago they gave them a highlight session which they did not use and confused everyone about who was going to present.

Who is to blame? The bad markets, moderna, the illuminati?

2/2 (cont)

You'd be lucky to have full iscib1+ data by end of 2025 in my view.

- Since the AACR presentation, they have stopped specifically referencing the recist 1.1 protocol in RNS or presentations. As explained several times, this includes indicating new lesions. For the first time LD mentioned new lesions in the interview but showing up before the 13 week timepoint. Whether that's the case or if something more than that is happening I don't care to think about anymore. As far as I am concerned the recist 1.1 protocol reference should be attached with any data presentation. It has not since last May.

I hope a decent deal comes to the rescue for you because if they need to raise again, I think it will be painful.

Good luck guys. And keep it real

Quick one as after what happened (including watching the latest interview) I really don't want to waste any more time with this company any longer. Selection of patients? WTF?

Note that in the first 13 it was 85%(11/13) while with the next 12 (to get to 25) it was 58% (7/12). Within statistical probabilities but I'll let LD explain to you by email what she meant by patient selection.

Here goes in bullets.

- SCIB included epitopes that were identified in patients that spontaneously recovered, so pre validated in a way. Not the case with iSCIB1+.

- As I mentioned more than a year ago, because iscib1+ has these new epitopes, we don't know how they work. Iscib1+ is

now fully recruited with non hla a2 patients, so surely we have data on some of those. No mention though on how they are doing. You get the drift.

- iscib1+ on the hla a2 population should perform similary to scib1 but here is the thing, in my view iscib1+ is not eligible for orphan designation because it addresses a larger population.

- Therefore if in non hla a2 patients efficacy of iscib1+ is not great and is no longer eligible for orphan drug status it makes no sense to move forward with it. That's because scib1 original patent is as good as expired so they either use orphan status with scib1 for 6 years exclusivity or they riak someone else copying scib1 and undercutting iscib1+ in hla a2 patients.

- They cannot use iscib1+ that has the patent extension to only target hla a2 patients and keep the orphan drug status because the FDA would view that as salami slicing which they don't allow since 5 years ago at least.

- Avidimab mechanism of action is that it increases residence time of a regular antibody on the antigen, making it "slow off". It's a neat trick (that can be copied by the wat by using a different dimerisation method). SCIB is not a regular antibody though, the regular variable reguon that normally binds to the antigen has been replaced with the melanoma epitopes.

- So why are scancell saying it has higher avidity in T cells. Well, they are the only ones saying that and the data is published in the patent I talked about in my first report (check my very first comment on this thread). There, in a mouse study they showed that iscib is a lot better than scib. In fact in that study scib had almost no activity at all. However, in the original mouse experiment (also shown in the same patent) where they tested scib (different mouse model), it was obviously active. So this high avidity t cell argument due to avidimab is based on a specific mouse model and smells rotten to me.

The good news is at least if scib1 continues to show >70% response to the end, that gives you a much quicker pathway to starting the phase 2/3. iSCIB1+ is dead in the water in my humblest of opinions but if they decide to wait for that, it now has to recruit the hla a2 patients (same as scib1). About 20 of them. Do the math with the several recruitment data points we have already fr

Not sure why you are so upset. If you think the market is wrong, that's a VERY good position to be as an investor. If you are right of course.

They are now only reporting on patients that have reached week 25, therefore per protocol. They should have clarified this from the start instead of leaving investors who are not familiar with clinical protocols scratching their heads. 72% given they can only report from a subset right now is good, not as good as you were fantasising, but good nevertheless. Told ya you (AND LD) were digging a hole for yourselves.

Even more positive for me is that they took a step towards reporting PROPERLY. There is still a bit to go towards that direction though.

More or less what I expected, definitely a lot better than I feared.