US Stem Cell Inc (USRM)

[Dragon Lady]

"They have been around for years and are currently in phase 3 trials for FDA approval of its lead product Myocell in the US."

Well, actually no. Their phase II/III trials have not advanced or moved forward one iota for quite some time for "lack of funding", the myocell trials stalled out since about 2009/2010. Further, Myocell isn't even protected under patent any longer.

Latest 10-Q, just filed for Q-3 ended Sept 30, 2014:

PAGE 29:
'We are seeking to secure sufficient funds to reinitiate enrollment in the MARVEL and REGEN trials. If we successfully secure such funds, we intend to re-engage a contract research organization, or CRO, investigators and certain suppliers to advance such trials. We have initiated and enrolled our first patient in the MIRROR trial in 2013. The trial is very similar to the MARVEL trial but focusses on sites outside the US. We will continue enrollment in the MIRROR trial once we have secured sufficient funds."

"We received approval from the FDA in July of 2009 to conduct a Phase I safety study on 15 patients of a combined therapy (Myocell with SDF-1), which we believe was the first approval of a study combining gene and cell therapies. We initially commenced work on this study, called the REGEN Trial, during the first quarter of 2010. We suspended activity on the trial in 2010 while seeking additional funding necessary to conduct the trial."

Thus it's quite clear there is no "phase III" trials taking place at this time, and two of the trials have been "dead in the water" going on almost 5 yrs now. The 10-Q is the document to read IMO, not PR links or links to blogs by penny stem sites or similar. You won't find the full story, or all the relevant facts there IMO.

Prior 10-K filed, PAGE 16:
"Our MyoCell product candidate is no longer protected by patents, which means that competitors will be free to sell products that incorporate the same or similar technologies that are used in MyoCell without infringing our patent rights. As a result, MyoCell, if approved for use, may be vulnerable to competition in the form of products that use the same or similar technologies. We have previously licenses certain patents and patent applications relating to our MyoCell product candidate. These licenses have all lapsed as of the date of this report, "

Further, from the latest 10-Q, BHRT is presently spending almost nothing on R&D, again, as they are not funding any phase II/III trials. This latest qtr saw them spend a paltry, approx, $3K per month on R&D, not even close to enough to fund any kind of phase II/III FDA level trial- not even close.

10-Q, PAGE 5: (this is spending for a 3 month period)
Research and development: $8,581

Also, one needs to read the full income statement and balance sheet to see that any "revenues" have been off-set by large increases in the company's expense line entries. Resulting still in large operational losses and cash short falls.

10-Q, PAGE 5:
Net loss from operations
2014, most recent 9 month period: (2,545,703)
2013, most recent 9 month period: (2,190,385)
Thus one can clearly see, that despite "revenues", the company actually has a greater net loss from operations in 2014, than the same yr over yr period in 2013.

The company is still relying on convertible debt to finance day to day operations (toxic financing, floorless convertible share deals)

Most recent 10-Q, PAGE 26: (one can see, the amounts of these deals are small amounts of cash, indicating how cash desperate the company is to take on such horrible financing terms, with steep share discounts, high interest rates, and high dilution of the common shares)

"Subsequent financing
KBM Worldwide
On October 6, 2014, the Company entered into a Securities Purchase Agreement with KBM Worldwide, Inc., for the sale of an 8% convertible note in the principal amount of $38,000 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on July 8, 2015,. The Note is convertible into common stock, at holder’s option, at a 45% discount to the lowest daily trading price of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal and accrued interest at 150%, and any other amounts.

Daniel James Management
On October 3, 2014, the Company entered into a Securities Purchase Agreement with Daniel James Management, Inc., for the sale of a 9.5% convertible note in the principal amount of $25,000 (the “Note”).
The Note bears interest at the rate of 9.5% per annum. All interest and principal must be repaid on October 2, 2015. The Note is convertible into common stock, at holder’s option, at a 47% discount to the lowest daily trading price of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal and accrued interest at 150%, and any other amounts.

Magna Equities, LLC
On October 7, 2014, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with Magna Equities II, LLC, a New York limited liability company (“Magna”). The Purchase Agreement provides that, upon the terms and subject to the conditions set forth therein, Magna shall purchase from the Company, a senior convertible note with an initial principal amount of $307,500 (the “Convertible Note”) for a purchase price of $205,000 (an approximately 33.33% original issue discount). Pursuant to the Purchase Agreement, the Company issued the Convertible Note to Magna. The Convertible Note matures on August 7, 2015 and, in addition to the approximately 33.33% original issue discount, accrues interest at the rate of 12% per annum."

The Magna $3 million credit line spoken of, will also be highly dilutive and is spread over a 24 month period- so it's inaccurate to imply the company suddenly has $3 million cash available to them. That just not the case- they can only "draw" on the line to a certain amount, periodically. Thus cash can only come in spread over a period of time, and will result in large shareholder dilution.

10-Q, PAGE 26:
"On October 23, 2014, the Company entered into a common stock purchase agreement (the “Purchase Agreement”) with Magna Equities II, LLC, (the “Investor”). The Purchase Agreement provides that, upon the terms and subject to certain conditions, the Investor is committed to purchase up to $3,000,000 (the “Total Commitment”) worth of the Company’s common stock, $0.001 par value (the “Shares”), over the 24-month term of the Purchase Agreement. In connection with the execution of the Purchase Agreement, on the Closing Date, the Company and the Investor also entered into a registration rights agreement. (see above)"

The company has been diluting shares at a furious pace, more than doubling the outstanding shares in less than a 1 yr period, this is most likely resulting in a lot of the downward selling pressure in the stock price (notice it's at about 1.5 CENTS right now) - as much of these dilution shares are given out at steep, steep discounts, often 10's of millions of shares at one cent, sometimes even less than one cent.

10-Q PAGE 9:
" Fully diluted shares outstanding were 659,543,477 and 323,296,916 for the three months ended September 30, 2014 and 2013, respectively and 605,015,919 and 336,682,241 for the nine months ended September 30, 2014 and 2013, respectively."

Thus at 1.5 cents a share, the company is surpassing 650 MILLION shares of stock outstanding (they recently authorized 2 BILLION shares available, and the Magna new financing will add a great deal more dilution to that 650 million number)

The company is in fairly dire financial condition per their own Sr management's statements and that of their own auditors. Here is the warning statement they've issued to disclose that poor financial condition:
10-Q, PAGE 12:

"NOTE 2 — GOING CONCERN MATTERS
The accompanying unaudited condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying unaudited condensed financial statements, during nine months ended September 30, 2014, the Company incurred an operating loss of $1,247,199 and used $747,184 in cash for operating activities. As of September 30, 2014, the Company had a working capital deficit (current liabilities in excess of current assets) of approximately $10.0 million. These factors among others may indicate that the Company will be unable to continue as a going concern for a reasonable period of time.
The Company’s existence is dependent upon management’s ability to develop profitable operations and to obtain additional funding sources. There can be no assurance that the Company’s financing efforts will result in profitable operations or the resolution of the Company’s liquidity problems. The accompanying statements do not include any adjustments that might result should the Company be unable to continue as a going concern."

http://www.sec.gov/Archives/edgar/data/1388319/000114544314001305/d31740.htm

Those are just some "highlights", again, use the SEC filed document IMO, as your best source of information about the true situation and condition of the company. PR and blogs and similar sources are not of much value IMO. SEC filed documents are legally binding and must be signed by company Sr. Mgt and be sworn to be accurate, etc.

Just my 2 cent opinions. Good luck to you.