US Stem Cell Inc (USRM)

[Dragon Lady]

LOL quote, "Dude this should be a $300 million market cap now even without the flagship Myocell approved yet IMO If you look at the competitors"

All except the part about how they haven't done a serious Myocell trial since about 2009/2010 and it's now 2015. Further, they have no more PATENT on ole Myocell.

How's that ole Myocell SDF-1 trial "re-start" working out now that it's Q2, from the "big presentation", LOL?? Wonder which part the $36K cash they had left on-hand, end of 2014 is going to pay for a large, FDA, Phase 3 trial??

Remember MIRROR, the magic vanishing "FULLY FUNDED BY BIOHEART PHASE 3" supposed "trial"- all except the part that it NEVER ACTUALLY HAPPENED, LOL !! ONE patient "enrolled" and then never heard about again, until a one-line in some vague "PR" said it's gone, over, done, never actually took place? Another BHRT classic.

http://www.marketwired.com/press-release/bioheart-announces-phase-iii-mirror-trial-for-myocell-initiated-otcqb-bhrt-1807938.htm

MIRROR, LOL. Yeah.

From the latest filed 10-K, MARCH 2015, PAGE 9:

"MyoCell 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 addition, many of the patent and patent applications that have been licensed to us that pertain to our other product candidates do not cover certain countries within Europe."

PAGE 11:

"MyoCell SDF-1 Patents

To develop our MyoCell SDF-1 product candidate, we rely primarily on patents. We had an agreement to license patents from Juventas. These patents relate to methods of repairing damaged heart tissue by transplanting myoblasts that express SDF-1 and other therapeutic proteins capable of recruiting other stem cells within a patient’s own body to the cell transplant area. We believe we will also need to, among other things, license some additional intellectual property to commercialize MyoCell SDF-1 in the form we believe may prove to be the most safe and/or effective.

In February 2006, we signed a patent licensing agreement with the Cleveland Clinic which provided us with the worldwide, exclusive rights to three pending U.S. patent applications and certain corresponding foreign filings in the following jurisdictions: Australia, Brazil, Canada, China, Europe and Japan, or, collectively, the Cleveland Clinic IP, related to methods of repairing damaged heart tissue by transplanting myoblasts that express SDF-1 and other therapeutic proteins capable of recruiting other stem cells within a patient’s own body to the cell transplant area. The term of our agreement with the Cleveland Clinic expired in July of 2009, when the license to the patents was turned over to a Cleveland Clinic affiliate, Juventas. We have an understanding with Juventas to restore the license to the patents once certain milestones have been achieved by Bioheart."

They HAD, past tense a license and now they DO NOT. They have an good ole "agreement" LOL, the ole "agreement" wording, whatever that means. So they don't have the rights to Myocell SDF-1, but are supposedly going to run trials on it, you know, with the $36K cash they had left end of 2014, per this same SEC filed 10-K, LOL??

PAGE 45, now over FIVE YEARS since they've had an actual FDA level clinical trial involving Myocell, it's gone nowhere since then. FIVE YEARS it's been parked.

"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. 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 focuses on sites outside the US. We will continue enrollment in the MIRROR trial once we have secured sufficient funds."

The big "new biz plan" PR came out after this 10-K was filed, and slipped in a one-liner that MIRROR IS GONE. OVER. Never actually happened in the first place. So the line above about MIRROR being re-started, not true according to the big ole "new plan" they put out in PR not long after this 10-K was put out. MIRROR enrolled "ONE PATIENT" and then sat for 1.5 yrs, and apparently now is never to be heard from again, even though the initial, grand sounding MIRROR "PR" said/claimed that big ole supposed phase 3 was, "FULLY FUNDED BY BIOHEART", all except the little tid-bit part that it actually wasn't "funded" at all, as it never actually even happened, LOL.

From the 10-K, filed with the SEC end of 2013 (they "scrubbed" a lot of this wording from them most recent 10-K it appears, which is fascinating in itself IMO. All word such as "DEATH" appear to have been "scrubbed" Orwell style, from the 2014 filed 10-K, like they were never in the prior 10-K filings. But the ole SEC has EDGAR, so things don't just vanish)

http://www.sec.gov/Archives/edgar/data/1388319/000114544314000356/d31044-10k.htm

PAGE 31:

"Our product candidates may never be commercialized due to unacceptable side effects and increased mortality that may be associated with such product candidates.

Possible side effects of our product candidates may be serious and life-threatening. A number of participants in our clinical trials of MyoCell have experienced serious adverse events potentially attributable to MyoCell, including six patient deaths and 18 patients experiencing irregular heartbeats. A serious adverse event is generally an event that results in significant medical consequences, such as hospitalization, disability or death, and must be reported to the FDA. The occurrence of any unacceptable serious adverse events during or after preclinical and clinical testing of our product candidates could temporarily delay or negate the possibility of regulatory approval of our product candidates and adversely affect our business. Both our trials and independent trials have reported the occurrence of irregular heartbeats in treated patients, a significant risk to patient safety. We and our competitors have also, at times, suspended trials studying the effects of myoblasts, at least temporarily, to assess the risk of irregular heartbeats, and it has been reported that one of our competitors studying the effect of myoblast implantation prematurely discontinued a study because of the high incidence of irregular heartbeats. While we believe irregular heartbeats may be manageable with the use of certain prophylactic measures including an ICD, and antiarrhythmic drug therapy, these risk management techniques may not prove to sufficiently reduce the risk of unacceptable side effects.

Although our early results suggest that patients treated with MyoCell do not face materially different health risks than heart failure patients with similar levels of damage to the heart who have not been treated with MyoCell, we are still in the process of seeking to demonstrate that our product candidates do not pose unacceptable health risks. We have not yet treated a sufficient number of patients to allow us to make a determination that serious unintended consequences will not occur."

Yeah, it "should be" worth $300 million or some other imaginary number why? That actual market cap is about $5.5 MILLION, not $300 million. That market cap is being set by the free market demand for their common shares.