NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Koman… there is one correction that I’d like to point out in your IMUC enrollment figures.

The IMUC phase 2 trial enrolled only 124 patients, not 278 patients.

I can see where you could have come up with that number as it appears that IMUC listed the enrollment figure of 278 at least four times in various press releases and on their presentation slides, and then later corrected the enrollment figure to 124 in their later press releases.

It’s seems rather odd, and might actually be a violation of some sort of SEC rule, as I don’t think you can refer to the number of patients screened as the number of patients enrolled, if that’s what they were doing. And it certainly seemed, at least for awhile, that they were actually enrolling more patients in their P2 trial than NWBO was in their P1 trial, which seems misleading, at the least.

However, as you can see here, the enrollment numbers did change. Here is an example of one of their incorrect press releases (one where you may have gotten that number):

http://investors.imuc.com/releasedetail.cfm?ReleaseID=730798

ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT:IMUC) announced today that the company has completed enrollment for its Phase II randomized, double-blinded, placebo-controlled, multi-center trial of its dendritic cell-based cancer vaccine ICT-107 for treatment of glioblastoma. A total of 278 patients at 25 participating sites have been enrolled in this trial , which was initiated in January 2011.

And then here, you can see the enrollment number has changed.

http://investors.imuc.com/releasedetail.cfm?ReleaseID=813442

A total of 124 patients were randomized at 25 clinical trial sites in the US.

That would mean, according to your formula, that the IMUC cost per patient was NOT $49,000, but rather $110,483 (more than double your original number).

And if you take the same methodology you used earlier, and compare it against two other immunotherapy companies, Kite and Juno, you’d find their comparisons are more in keeping with NWBO. Juno’s R&D figures for 2014 are $2,939,000 and Kite’s R&D figures for 2014 are $23,089,000.

JUNO
Juno’s R&D - $2,939,000
Juno’s trial had 13 patients in it.

http://ir.junotherapeutics.com/phoenix.zhtml?c=253828&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTEwMjY3NjA3JkRTRVE9MCZTRVE9MCZTUURFU0M9U0VDVElPTl9FTlRJUkUmc3Vic2lkPTU3

JUNO’s cost per patient enrolled (13) for 2014 was $226,076

And so far, for 2015, JUNO’s R&D expenditures equals $57,799,000.

KITE
KITE’s R&D - $23,089,000.

From what I can see, it appears KITE has about 4 trials in progress. However, most of those trials are most likely nowhere near full enrollment. And their Form 10-K doesn’t provide a patient number.

http://ir.kitepharma.com/secfiling.cfm?filingID=1564590-15-1985#KITE-10K_20141231_HTM_ITEM_1_BUSINESS

Those trials are:

NCT01967823 - 29 enrolled in 2014 (estimated total enrollment - 43)

NCT02280811 - 0 enrolled in 2014 (estimated total enrollment - 61)

NCT02111850 - 30 - guesstimate (estimated total enrollment is 107 - 2 year enrollment = 5 pt. p/mo / July - Dec 2014: 6 months x 5 = 30 patients)
initiated April 9, 2014 (3 months ramp up - July 2014 with December 2016 listed as estimated primary completion date)

NCT02153905 - - guesstimate (estimated total enrollment is 102 - 3 year enrollment = 3 pt p/mo / August - Dec 2014: 5 months x 3 = 15 patients)
Initiated May 2014 (3 months ramp up - August 2014 with June 2017 listed as estimated primary completion date)

Based on what we know and my clumsy guesses… that would equal 74 patients enrolled in 2014. And if we wanted to be generous with those numbers, let’s add on an addition 26 patients for good measure to round it up to 100.

KITE’s cost per patient enrolled (100 - a generous guesstimate) is $23,089,000 = $230,890

However, and more importantly, I don’t think that dividing the R&D costs by clinical trial patient numbers is really the way to look at this anyway.

One should probably consider these R&D costs as “development costs” for a product. As abeta points out on YMB, the first aluminum truck was the Ford F-150 and overall development costs may have been well over a billion dollars. Does one then say all future Ford F-150s will cost a billion dollars each? No.

The same can be said about these clinical trial patients enrolled in NWBO’s trials. One might want to consider that the first 400 plus patients (or their results) are the prototypes for the DCVax-L product. The same can be said for the patients of any of these clinical trials referenced here. The R&D prices that these companies are paying will include all kinds of “costs”, and dividing those costs by guesstimates of the prototype numbers, and then judging their validity or not by what you arrive at, is not necessarily the way to do it. When one is seeking a cure to, or even a halting of, cancer, I'm sure many patients and their family members would agree that no amount of money is enough.

Research costs DOES NOT EQUAL production costs.