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Re: Pecuniam post# 770

Friday, 09/25/2009 10:16:40 AM

Friday, September 25, 2009 10:16:40 AM

Post# of 6471
Perhaps the information given in the IBOX etc needs a little bit of refinement.

1. Probably the most current information from the company is contained in their filings with PinkSheets. See http://www.pinksheets.com/pink/quote/quote.jsp?symbol=vral and check out the docs under the "Filings" tab.

The two meatiest things there are their "Initial Company Information and Disclosure Statement" and the assocaited financial disclosures from March, and a copy of Newell's presentation from last week.

2. Their current candidate isn't "VGV-1" but a new thing they are calling "VGV-X". They say VGV-1 didn't stack up as a commercial drug candidate, at least for the developed markets; hence the new "VGV-X".

Newell's presentation says: "VG’s first generation product [ie, VGV-1] showed decreased virus levels and increased immune activity in some but not all HIV infected individuals."

The information statement has more detail: "The [South African] results [for VGV-1] indicated statistically significant reductions equivalent to a 70% decrease in the amount of virus in their blood in 22% of patients overall at day 150 (approximately three months after treatment)."

And: "In the past, we observed that between 20-60% of patients treated with VGV-1 experienced a statistically
significant reduction in their levels of HIV virus of 70-90%. In order to be approved as an HIV/AIDS drug in the US and Western Europe, we believe that we must achieve a more consistent percentage of successful patients on the order of 90%, and that we must reduce levels of HIV virus by at least 90-99%."

They say that Newell has done a bunch of further work resulting in "our HIV/AIDS candidate, VGV-X (the second generation version of VGV-1)" which they hope will hit these targets.

3. From Newell's presentation, VGV-X appears to be starting from scratch, as far as the regulatory process goes. She says they need $1.5M to do the pre-clinical animal and other work, which doesn't seem to have begun yet. Assuming that it does start round about now, she says they will then need a further $1.5M for Phase I trials starting Q1 2010, $10M for Phase II starting Q3 2010 and $30M for Phase III starting end 2011.

Unless things have changed for the better since March, VRAL doesn't appear to have any cash, let alone enough to get the ball rolling on this, so the timeline seems ummmm "ambitious".

(The latest financial info is from the March disclosure statements. As of then they had zero cash, zero other current assets, and zero revenue. It says they will "need to raise approx $2M to $3M over the next year" to do the pre-clinical work and get the IND filed for the Phase I.)

4. The CEO, Haig Keledjian, is a lawyer, not a scientist. His bio from the last 10-K they filed, back in 2007:

Mr. Keledjian formerly practiced tax and estate law and litigation in the State of California. He received his B.S. in Business and Accounting in 1983 from California State University (Los Angeles), followed by a Masters degree in taxation (MBT) from Golden Gate University in 1985. In 1989, Mr. Keledjian completed his undergraduate law studies by obtaining a B.S. in law from Glendale University and in 1991 obtained his Juris Doctorate from Glendale University. He was admitted to the bar of the State of California in 1993.

(BTW, his CA state bar record makes it clear that his law school was actually the accredited Glendale University College of Law, and not the unrelated diploma mill, Glendale University.)

5. As of the March disclosures, the company had two full-time employees, who seem to be the CEO and (I think) somebody called Monica Ord, VP Corporate Development. Though Ord is also referred to as a consultant. Newell's presentation lists the CEO, Ord and herself (as "scientific advisor") as the "key personnel". I assume that Newell keeps her university day job, consulting to VRAL, and the disclosure filing has some details of VRAL commitments to subsidize her in this.

6. The Board is just the CEO and his brother.

7. Control of the company is locked up by the insiders. In a transaction which seems to be reported only in the PinkSheets disclosures, after the fact, the insiders got this control at the end of last year. They appear to hold super-voting preferred shares which guarantee them 50.1% voting power, no matter how many common stock are issued. I don't see any record of a shareholder vote or in fact any kind of communication to shareholders about this apart from the PinkSheets filing, but maybe I'm missing something.

8. The company and the CEO are being sued in federal court in Northern Illinois by (I think) former investors who had some kind of rights and obligations with respect to the former South African operation of VRAL.

These guys claim that the CEO lied about owning the rights to VGV-1, about distribution rights and the existence of pre-clinical evidence.

VRAL and the CEO are counter-suing, claiming that these guys conspired to damage the company and steal its IP. They give a brief overview of their version of the case in the PinkSheets disclosure filing.

The plaintiffs appear to be about to file a motion for summary judgement/dismissal on the counter-claims from the CEO and VRAL.