US Stem Cell Inc (USRM)

[Dragon Lady]

"BHRT is on track to be first to market with a heart stem cell solution if approved by the FDA."?? How?
BHRT's main, furthest advanced phase II/III trials have gone nowhere in over about 4 yrs now. Nothing has "advanced" making them "on track" for anything IMO? MIRROR, the word/trial, did not even appear in the last 10-Q filing, not a single time. At last update, approx, one yr ago, it had "ONE patient enrolled". A typical time period for a phase III trial like that, to even reach "completion", let alone preparation to "submit" to the FDA, let alone the time for the FDA to "review/consider" it for "approval", let alone that they would successfully "approve" it, would be year(s), as in several yrs MINIMUM, per any generally accepted, industry "norms", IMO and all of the published, similar "trials" I'm familiar with ever reading about.

For example, here is a phase III, "stem cell", "heart" type trial being conducted by a cash/staff rich company, Baxter healthcare. (approx. 60 THOUSAND employees at their disposal, $BILLIONS to spend if needed). They list the following:
Enrollment: 291
Study Start Date: April 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

They are listing about FOUR YEARS until they "estimate" even "final data/completion". That's a company with some of the finest, most successful, most experienced FDA regulatory "trial" people and submission experienced people on this planet at their disposal, IMO. And they need FOUR YEARS according to their clinicaltrials.gov filing. They have entire "departments" to handle these trials and the FDA regulatory work, probably 1000's of people total, with budgets in the $100's of MILLIONS of dollars, purely dedicated to "trials" and "FDA submissions".
https://clinicaltrials.gov/ct2/show/NCT01508910?term=baxter+stem&rank=9


In that same time period (from mid 2009/2010), BHRT declined from about a .60 to .70 cent stock (spike to $1 or so) to now essentially a 2 cent stock. They had about 42 million shares outstanding then, and today it's about 500 MILLION shares outstanding, despite those phase II/III trials going essentially nowhere (see their own 10-K/10-Q for last "updates" regarding the MARVEL or REGEN trials as examples).

In that same, approx. time period, they've are now on their 3rd CEO, they've had mass layoffs/departure of staff, mass departures at the Sr. mgt and BOD levels, and have been down to about 3 full time, most recently now 4 full time and one part time "employees". Many who left/laid off/departed or whatever, were their people who had FDA regulatory submission and FDA "trial" experience, according to past company filings, PR and similar.

There is not a single indication IMO, that they are even remotely close to being ready to complete (as in yrs away) a single, phase III trial, let alone have the financial resources or staff resources to do it, let alone prepare and submit it to the FDA to even be considered for approval. I see no proof of that happening anytime in the near future (even distant future IMO).

The entire market cap of the company as of Friday, sits at about $9.4 million dollars, and they are heavily debt laden. Most of any cash they raise or spend (or common stock shares they pay out as "payments"), goes to IMO, from reading their 10-K/10-Q filings 1) SG&A expenses (salaries and "other" stuff) and 2) Interest on their debt and 3) Payments to "others" like Northstar for example, per their own SEC filings. They have little to no cash on any given month to month basis (maybe $100K to $200K per month max, at most, usually less, per past 10-K/10-Q filings). They are typically so low on "cash", that they use common shares of stock to "pay bills", as in handing out 10's of MILLIONS of shares of stock per the last 10-Q. (see last 10-Q filing, PAGES 23/24 as examples)

They spent a GRAND TOTAL of about $10K on R&D for the entire Q-1 period, 2014 (most recent 10-Q, PAGE 5, $9,857 entry). That would be about $3K a MONTH for "trials". It's IMPOSSIBLE IMO, to complete any type of FDA type "trial", let alone prepare the enormous paperwork and submission documents necessary, using $3K a month in spending, and having a staff of only 4 full time and 1 part time "employees", several who have zero FDA regulatory experience, and have never successfully navigated a single product/process to any FDA approval in the past, per their own resumes, as posted in company documents.


"Patent or no patent they have potential to be first to a billion dollar market. "
According to the Sr. Mgt's own warnings and statements in their own SEC filed documents, they are "at risk" in many ways to even continuing to exist as a company, or have a FDA approved product to ever sell: from lacking patents, to serious "adverse effects" in the trials to date, to lacking staff and money, to being a "going concern/liquidity" risk, etc from that "potential" happening, IMO and apparently their opinion also. It's a million mile stretch IMO, to go from a market cap of $9.4 million, a 2 cent share price w/ 500 million shares out, and a lot of debt, to just suddenly being a "BILLION dollar market". Who's BILLION dollar market? How? Where? Selling what product(s)? It's not even known IMO, that there is even a $BILLION market out there? Let alone, BHRT being "first" to it?

Don't see the connection whatsoever IMO.