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To: PoorOpinion who wrote (1540)3/31/2016 6:20:58 PM
From: Dave@SI  Read Replies (2) | Respond to of 1728
 
PO, Hi
Thanks for the comment, to discuss....

The gene signature proof - agreed not many patients, but could/would they also use non-clinical trial data to help confirm the data for whatever correlation? And it's not like we're dealing with troublesome right-skewed survival data? So is it not possible that they could have good correlation? At least enough to make it worth sub-categorising patients to maximise the trial prospects? But even if they didn't positively select the patients they would surely pretest to ensure that they included a big enough proportion of likely responder patients to be able to further validate the signature, so would have a similar effect in terms of trial outcome (if it works).

But also I note that there is almost as much conditional language in their NR as there is in my paragraph above (but I'm not a pro!).

Agreed about cash problems, back on 2015-09-30 Wagner was interviewed ("The Life Sciences Report"):
JW: The cash-on-hand figure is from our Q2/15 financials, filed with SEDAR. We believe we have enough capital on hand to initiate and get into our upcoming clinical study.

We're an early clinical-stage biotech company. We obviously need to raise additional capital to reach our milestones, particularly as we get into larger and larger clinical studies.

I'm a fundamentalist in terms of driving business, and I have reached critical milestones on less than a bootstrap in one of my prior companies, which was eventually acquired. I believe that if we can focus and execute, which we are doing, our valuation will increase, and we will raise additional capital through traditional means.

We will rely on equity financing and would strongly consider nondilutive financing. Once we begin the clinical study, we would be eligible for nondilutive California Institute of Regenerative Medicine (CIRM) funding. The U.S. National Institutes of Health provides Phase 2 SBIR (Small Business Innovation Research) grants, which can provide significant nondilutive funding. Of course, partnerships are another option. The deal flow is heavy in this space. We would consider, under the right terms, co-development or any sort of partnership deal with an immuno-oncology-focused big pharma or big biotech company.


which seemed to give some hope the trial would at least start and that we might not be so badly diluted.... Just in case you haven't seen it, on SH stateside commented that there is a good chance that warrants have been cashed, up to 13m ITM. Rather telling perhaps that the sp seems to be not dropping below the 25c strike mark (ie fewer sellers below there). One other kind of related point to note is that there are still shares in Escrow, approx 5.4m released every 6 months (Dec and June I think), see MD&A.

Anyway, here's hoping there will be some progress, and some early end point - anything you can tell us about surrogate (or whatever you call it) end points for this treatment?

And, OT, just in case it is of interest, have a look at Scancell's (UK-based) SCIB1 melanoma Phase I/II results, non-toxic no mortality, generally no regression for resected higher dose patients so far, median 42 months, but small data set (see 2016-01-27 six month interim financials for latest summary). Any insight would be appreciated, turns out they can't get a deal as quickly as they thought (not enough data it seems, cash raise just closing, more trials (and raising) to come). This is a "platform" approach (SCIB1 comes from ImmunoBody platform), and they also have a " citrullinated tumour-associated peptide epitopes " platform candidate slated for clinical next year. For a recent video see youtube.com, note we (Scancell) were a bit unknown in US but finally got some attention in the US, from about 27:40 see mention of Keith Flaherty/Sloan Kettering.

Cheers