Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
"The last time I emailed Mike about someone mentioning the mirror trials being postponed on this message board, he said that was material information and it will be discussed in the upcoming 10k so we shall see."
That was the quote of a post a week or so ago. The MIRROR trial in the 10-K barely got a mention. A few lines of boiler plate, same as in last 10-Q. So did he "discuss" it in this 10-K? I guess a few lines could be called "discussed" if you split hairs? But I don't think that's what was "implied" - as in, an update would be given? Just my opinion from reading what supposedly transpired in that email quoted above?
Now, we're being told today that MIRROR "might" be addressed via Comella in a "blog or something" (based again on a CEO private EMAIL?), we'll see?
So this "Mike has been emailed" and then his responses are to be taken over the info in the 10-K? I'm not clear here and it's very confusing IMO?
"The 10K is 2013 this is 2014"
They included 2014 "updates" regarding other matters in the 10-K. Look at the financing updates that go right on through late Feb of 2014.
I believe there are other 2014 matters "updated" too- will read again, and see if I can find them.
So it appears they can provide update info right up until the day before the 10-K was filed, which is up to March 24th or so. So why wouldn't it have been included? They made a point to show their cash position "updated" - so why not MIRROR?
You tell me/us please? Would like to know- why do it in a "blog" or whatever. That's my opinion.
The "Mike was emailed" again response, and he asked "was it online"? Really? The CEO worries about/cares what is said "online" when they just put the 10-K out and Mirror didn't even get more than a few lines of mention?
So, he states that he will send Comella out to "update" in a blog or whatever? How can she update via a blog, but the same info was not in the 10-K? What sense would that make?
The 10-K is the LEGAL means by which a public traded company communicates. NOT by private emails to someone on a chat board and then via a "blog" to "add" info that was not in the 10-K just released. That's my opinion(s).
Seems like no matter what happens, no matter what their legal, SEC filings say, someone always claims it is/has been, or will be answered in some "private" email or later in a "blog" or whatever. Never seen/heard anything like it in following PUBLIC traded companies. Again, to each his/her own. Me, not buying it. 10-K for me is it. That's the document that matters, IMO only. Good luck with blogs, Pr's and emails. I guess we shall see.
As to "projecting" that certain things will "bare fruit" and all the rest- that's just that, "projecting". The numbers on the 10-K were about $5K a month in revenue. That's it at this point. "Projecting" is not easy to do, and the company has put out no formal "projections" as to revenue estimates per any of these "deals/projects" that I am aware of. Traditionally, it some companies would put out sales "projections" as they have sales managers, sales teams on the ground, and are making sales- and thus "project and make estimates" and set targets to hit for each qtr, mid yr, end of yr, etc. I am not aware of any "formal" or any sales projections at all being released by BHRT. I don't know how a person, via reading a few lines in a 10-K can "project" that sales will occur and "bare fruit" or how they'd even do that?
Further, Mirror was the key event being discussed for months. To not have expected "any enrollment update" when it's been since July, when they said ONE person "enrolled" seems odd? Why would everyone not expect an update and results when this was (past tense) essentially touted as the flagship product/project for the entire purpose of the company (Myocell and FDA approval?). Again, IMHO, not see it the same way, not at all. Good luck.
"In the last PR about Mirror they state that Mirror is "fully funded by BioHeart"... Which should mean that Mirror is funded."??
The 10-K states ALL "finances" and CASH sources available as of the date it was issued- there is no "secret" pile of money sitting somewhere or secret "funding" box/drawer that will be opened to "fund Mirror"?
Why does that PR/blog or whatever statement above keep getting repeated Ad nauseam? The 10-K IS IT, it's the binding, audited, legal "snap-shot" of where things are at. Again, there's no "money/funding box" hidden away. The 10-K shows the cash position as pretty desperate- with several warnings throughout it and continual "financing" deals being done right up until very recently, selling shares to Asher for instance for a mere $32.5K in cash. Would they be doing those convertible shares deals for that pittance amount of cash, cause there is some "lock box or stash" of big cash "funding" hiding away somewhere?
Read the 10-K and try and understand it. It's all that's needed to know IMO. It's the end all document, what is said in past PR or "blog" or whatever, don't count for much IMHO. The 10-K is there and is audited and is signed by the pertinent, key people for a reason.
Marvel and Regen appear to have been dead in the water and gone no where, as you stated, for several years now. Unfunded, unmoved, or whatever. The boiler plate language on them just gets repeated in every 10-Q/10-K each period. And yes, they sit on the .gov site as registered, but nothing appears to have progressed or changed on them.
Mirror got a "barely mention" in this 10-K and in the last 10-Q so where has it gone? Explanations keep getting posted that more info will come, that no info is "normal" given that XYZ was said way back when. Me, not buying it. Mirror was touted, blasted in PR as their "big thing and big push", not "medical tourism" or whatever else. If there was enrollment or other updates, they do not hold them back- in fact if it was "registered", one key thing that would need to be happening is timely updates on enrollment numbers, progress, etc.
Look at the R%D budget spending compared to overhead/salaries and so forth. I don't see how you run multiple trials plus all this other "stuff" all over the place on what, about $600K or so total spent in a yr, but almost 4X that was spent on salaries and rent and costs for a 4 or 5 person company?
None of it makes any sense to me. Broad claims have been posted that they would no longer be diluting/share selling because of "major revenues" now, etc. Didn't even come close. Sales were about $5K a month, which is nothing in the ballpark to fund trials or more- it doesn't even pay their rented facility rent for a yr. Posts claim they will have "big sales" and have product(s) plural to sell- as if this is their business now? I'm not seeing it, IMO.
What happened to being a "Heart" company pursuing high grade, FDA type trial(s) heading to an end game of approval? IMO from everything I've read now- I don't know? Debates are being posted here now splitting hairs on the dilution occurring over 5 months, or 5 months and a few weeks - as if it makes any difference in the slightest. The numbers were posted and clear- that the shares have doubled in less than the past one year and they are still diluting in the 35-40 million shares a qtr "range" right up until this 10-K was issued- so what difference does a week or 3 weeks make in the dilution calculation. 150 million a yr rate is probably on the low side as it was over 200 million last yr- but the hair splitters want to debate that, rather than WHERE DID MIRROR GO and other real important things- like all the posts about "income will replace dilution" being not even remotely true at this point- and no indication is there that, that will come true anytime soon IMO only.
It comes down to a blind love affair versus reality, I guess for some. To each his/her own. The report says what it says and there is no debate IMHO that they are in desperate straights for cash at any given time, and the report is the proof- as their are multiple statements and warning in their own words saying just that, and the "financing" terms (convertibles, share discount, early penalty pay off clause) are only getting worse at best, not better by any stretch. They did Asher and other "deals" right up until late in Feb. for around $30K or $35K of cash ea, meaning they need that much trickling in, just to keep things going. Right where that is stated, is their own warning that cash on hand is not even sufficient to meet their current needs/obligations and they must find sources continually (my paraphrase- I can give exact page number and quote 10-K for the debaters/critics). It is what it is and says what it says.
My opinion, they don't have the money to fund major trial(s) at this point- I just don't see how from the numbers put up in that 10-K, and that's just my opinion knowing what is typically said in industry and other credible publications about what a typical, major, phase II or III trial takes/costs to drive to completion. That's my take and opinion. See it any way you want for anyone else.
Sales were insignificant- not even close to "stopping dilution" as was posted many times previously.
Page 54, 10-K:
We recognized revenues of $96,085 in 2013 compared to revenues of $61,109 in 2012
Cost of sales consists of the costs associated with the production of MyoCath.
Cost of sales was $30,831 in the twelve-month period ended December 31, 2013 compared to $1,070 in the twelve-months ended December 31, 2012.
So they netted, or had a gross profit on the 2013 sales of $96,085-$30,831 = $65,254.00 / 12 = about $5K a month. That's a pimple on their cash use/burn rate.
Net cash used in operating activities was $1,913,326 in 2013 . (I'm not even sure if cash for interest on debt would need to be added into that number, pretty sure it would- their report is confusing to me, but lets just use that number above- since costs/cash use appear to be going up if anything from their statement of hiring a few people etc)
$1,913,326 / 12 = about $160K a month, cash needed to keep operations going "as-is", keep the lights on, pay themselves, whatever else they are doing.
So, $5K in sales / $160K cash used in operations = 3% of cash needs. Not hardly "stopping dilution" by any stretch. And again, I believe, need to read more- that they actually need more than that coming in to service debt interest and other cash going out. But $160K would appear to be a bare, bare minimum.
Also, as it appears in last 10-Q's, my opinion is the SG&A costs are mega high to the R&D budget and the size of the company- just my 2 cent opinion. But it seems most of the money goes to pay themselves or whatever "stuff" falls under SG&A, salaries usually being the biggest in that category (their rent is like $65K a yr, they say they carry no product liability insurance in the doc, etc- so what else would it be spent on?)
PAGE 61:
Research and Development
Research and development expenses were $626,983 in 2013, an increase of $225,042 from research and development expenses of $401,941 in 2012. The increase was primarily attributable to an increase in the amount of available funds.
The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing.
Marketing, General and Administrative
Marketing, general and administrative expenses were $2,267,831 in 2013, an increase of $89,479 from marketing, general and administrative expenses of $2,178,352 in 2012. The increase in marketing, general and administrative expenses is attributable, in part, to an increase in legal fees, salaries and insurance expenses.
Interest Expense
Interest expense was $1,437,883 in 2013 compared to interest expense of $1,619,653 in 2012. Non cash interest comprised of amortization of debt discounts and warrants issued in connection with debt totaled $597,339 in 2013 as compared to $657,081 in 2012. In addition, in 2012, we issued warrants in connection with a forbearance agreement with Northstar at a fair value of $430,213; in 2013 we issued preferred stock in in connection with a forbearance agreement with Northstar at a fair value of $274,050.
So about $600K was spent on R&D (trials, etc) and their Marketing (they have none really- they don't sell anything for the most part) GENERAL and ADMINISTRATIVE- the big ones in my opinion (salaries) was $2.2 million or almost 4X the R&D budget for a 4 or 5 person operation? Doesn't make sense to me, but that's my opinion?
It looks like Tomas and Comella got big salary (like BIG percentage wise) boosts or bonuses also on the compensation page (someone posted a while back- Tomas is RICH RICH (exact word the post used) and that he takes no pay)- but that's not what this document is saying:
PAGE 71:
Summary Compensation Table
The following table sets forth, for the fiscal years ended December 31, 2012 and 2011, the aggregate compensation awarded to, earned by or paid to our Chief Executive Officer and our two most highly compensated officers (other than the Chief Executive Officer), who were serving as executive officers as of December 31, 2013, or the Named Executive Officers.
Tomas $391K in salary + $375K bonus
Comella $159K + $125K bonus
Plus a bunch of options
(1)
On August 1, 2013, Mr. Tomas and Ms. Comella received $375,000 and $125,000, respectively, promissory notes for bonuses awarded. The promissory notes bear 5% interest per annum, unsecured and are due on demand.
(2)
On August 1, 2013, Mr. Tomas and Ms. Comella were granted 10,000,000 and 5,000,000, respectively, options to purchase the Company’s common stock at $0.01576 per share for ten years, vesting annually over four years.
(3)
On September 1, 2013, Mr. Tomas, as a member of the Company’s Board of Directors, was granted 400,000 options to purchase the Company’s common stock at $0.01654 for ten years, vesting immediately.
So, just those base salaries alone, for TWO people would consume $391K + $159K = $550K / 12 = $45K a month of their cash needs/use of $160K. That's 25% of cash used- going to pay TWO PEOPLE.
It's almost equal to their R&D budget (R&D for yr was about $626K), WOW. TWO people in a 4 or 5 person company (yahoo lists 4 full time employees), consuming-getting paid close to the entire R&D budget of what's deemed a "R&D development stage company"? And that's not including their bonuses listed- which would have them receiving more than the entire R&D budget for just 2 people? Wow? Tomas with base + bonus + options for 2013 has a compensation listed of $936,804.00 for a 4 or 5 person company with no sales, very little cash, lots of dilution and a micro penny stock price? Wow again IMHO.
I've worked for very profitable companies with about $200 million in sales, 1000 plus employees- and that's about what the CEO or maybe the most Sr. VP was pulling down, probably even less base salary for VP's- only making that much if they sold options they'd built up over yrs and yrs of working a very successful, highly profitable, NASDAQ listed company with a market cap of $400 million or so.
My 2 cents again, seems out of whack cost structure to me- but hey, that's just me. That's my take on some of the basic numbers- just my math, my number crunching and opinion only- could be wrong, it's late, I'm tired from reading the 10-K. But wow, it looks lopsided IMHO.
Corrected. So, on the last 10-Q it is listed as of Sept._____ and never filled in that blank. So we'll say it's for 4 to 5 months for 73 million shares of dilution (my opinion on my read of the documents).
So lets call it about 40 million a qtr. which will be over 150 million shares a year at this rate. Is that good? I'd say the common shareholders, in my opinion are getting heavily diluted no matter how you slice it.
Today, March 25 the share count now stands at about 420 MILLION shares.
It was only April of last yr that they were at 200 million and blew through their allowed number of shares per their charter, and just upped it to like 950 million or something allowed shares outstanding. It's easy to see now why they chose such an enormous number.
As of April 30, 2013, there were 200,623,903 outstanding shares of the registrant’s common stock, par value $0.001 per share.
So, in less than one yr, April 30 2013, to March 25th 2014, the common holder has seen the shares more than double, diluting them down by half (someone owning 10 million shares would have owned 5% of the company less than a yr ago 10 mil/200 mil, and now they own 2.5%, 10 mil/400 mil shares). The only thing that seems consistent is the constant selling/dumping of shares for every reason under the sun- I read through that 10-K and they hand out shares like water- for financing, for paying people, for debt payments- I can't even remember all the places they said they handed out millions of shares for XYZ or whatever.
So, yeah- the 73 million is for 5 months or whatever. If that's a good thing- well, I don't see it that way IMO. It's massive dilution IMO no matter how you slice it.
Several posts in the previous week made the claim the dilution will/would have stopped. Not even close, not even remotely close.
Cash update page 25, interesting: Looks like they put in an "update line" as of day before release- on their latest cash/debt position. They list $211K cash and equivalents (how much is actual "cash" versus "equivalents" - not enough info). So that Asher activity of $100K up through late Feb added some cash for sure, and maybe some of the recent income was booked- I see "some" income on balance sheet from catheter sales, services, etc. So cash beefed up a bit it looks like in the past 3 months, but that's typical of how they run usually- they sell shares, do "financing", get cash on the books good for a month or two of funding operations/burn rate, then wash, rinse, repeat. $211K per my guesstimate from the last burn-rate calc, is really only a month, maybe 1.5 months of cash? But it's better than the $40K or whatever on the balance sheet. Guess they did a "snap shot", last minute before the 10-K release (wonder if it's audited- I'd doubt it)- probably their best estimate of cash-on-hand and debt as of right now, all IMO.
Page: 25
"Risks Related to Our Financial Position and Need for Additional Financing
We will need to secure additional financing in 2014 in order to continue to finance our operations. If we are unable to secure additional financing on acceptable terms, or at all, we may be forced to curtail or cease our operations.
As of March 24, 2014, we had cash and cash equivalents of approximately $211,632.80 and a working capital deficit of approximately $13.4 million. As such, our existing cash resources are insufficient to finance even our immediate operations. Accordingly, we will need to secure additional sources of capital to develop our business and product candidates as planned. We are seeking substantial additional financing through public and/or private financing, which may include equity and/or debt financings, research grants and through other arrangements, including collaborative arrangements. As part of such efforts, we may seek loans from certain of our executive officers, directors and/or current shareholders. We may also seek to satisfy some of our obligations to the guarantors of our loan with Seaside National Bank & Trust, or the Guarantors, through the issuance of various forms of securities or debt on negotiated terms. However, financing and/or alternative arrangements with the Guarantors may not be available when we need it, or may not be available on acceptable terms.
If we are unable to secure additional financing in the near term, we may be forced to:
· curtail or abandon our existing business plan;
· reduce our headcount;
· default on our debt obligations;
· file for bankruptcy;
· seek to sell some or all of our assets; and/or
· cease our operations.
If we are forced to take any of these steps, any investment in our common stock may be worthless."
Gs, respectfully, I never discuss what I own, how much, etc. That's my personal business.
I will say this- my biggest (what's the word?) concern, at this point is that Mirror appears to have gone M.I.A.
From that, I open the question(s): What is BHRT really doing, trying to be, what is their end game now, or anymore? It's all getting muddled to me?
Are they really a legit, FDA trial pursuing, drive a product to the FDA big finish line, get approval and gain the kind of market cap that has been batted around? Or, have they "morphed" into some kind of "medical tourism" gig, hock/sell/pitch stem cells for every ailment known to man, all over the 2nd and 3rd world for whatever cash it brings in kinda deal? I mean, they are called BioHEART- but they seem to be losing their direction to me, my opinion only.
Do they merely exist anymore to sell/dump shares (73 MILLION this qtr alone) to keep the gig going as long as they can milk it- paying themselves salaries, paying back the Northstar insiders as much as possible, etc? I'm really starting to wonder where this is all supposed to be heading?
Given the financial realities- which no one can skirt around or deny are in pretty dire straights, and given that Mirror, again, just got a "barely mention" in your most important document you put out each yr- I don't "get it" anymore who, what, where they are, are going or trying to be? Really not seeing it? ED, eye stuff, animal Stemlogix, Middle East deal (notice- no mention typically of these "deals" when it comes 10-K time), Honduras, and on and on and on? What's the end game. What happened to the big goal? HOW can you possibly manage 10 or more major projects with 4 or 5 full time people- and also run a phase III trial(s)? How? And how to you do a phase III when your cash on hand at any given moment varies between about ZERO (really zero) and now about $40K or so? How? It's mathematically, biz wise impossible based on what is well known about what a legit, phase III and FDA submission takes to pull off and get to the goal line.
So, yeah- I see huge red flags in this 10-K at just a cursory read. I saw problems, big ones in the past couple of 10-Q's, but everyone had the "they have a new plan- it's turning around" kinda thing going on. Now, after first glance at this document- I'd say that's all up in the air in my, and my opinion only. This 10-K to me, nothing but same old, same old and some parts looking worse, more dire than ever. Not good in my opinion. Is the stock still a trade maybe- sure. Would I think to go real long now and feel good sleeping over weekends and all- I don't know? I think most now are "trading" this stock and that's a whole different ball game from being an "investor" in the company for the long haul. That's my 2 cents- I still need to spend at least an hour or more and plan to read every page, word for word on that 10-K.
Good luck to ya- if you believe, then hang tight- I just hope you don't have the life savings riding on it, or money you can't afford to lose. Nothing wrong with locking in some profits you know- it doesn't make you guilty or not a "believer" as I think someone else just posted- a very good way to put it.
Truthfully? YES, you could get those same discounts if you were willing to barf up, cold, hard CASH and give it to BHRT.
You understand why those guy's (Asher and such) can demand those terms, correct? It's because BHRT is deemed a very high risk entity to loan too (as in default someday is a real possibility). BHRT needs cash, Asher and similar are what's known as "lenders of LAST RESORT". They're the end of the road when you got no place left to go.
BHRT has no cash flow essentially, no assets per say, a lot of debt, etc. So Asher is willing to put up cash to lend- but they want, like all lenders, a pretty good shot at getting repaid, AND for the high risk, they want a high return. Not 5% like they can get doing foo-foo lending on autos or even pawn shop stuff. Dudes like Asher wanna make like 25% or more return on each deal- they're about a step away from some guy named "Gueedo" who works for the "mob" in some seedy neighborhood of Jersey. Everything short of the breaking the knee caps is about it IMO. The terms they demand are as brutal as they get- and they're pros, real, real good at what they do- as in making money going both ways (upside on stock and then brutal shorting to the downside on those convertible shares).
So yes, you could probably get some discounted shares if you were a registered, institutional broker/dealer and could cut checks for $30K chunks at a time. Notice- there's some new firm listed, "Danial James Mgt". I haven't even looked them up yet to see what their name and reputation is on "The Street". I'm sure they're probably well known too as a "lender of last resort" to micro-cap companies in the squeeze.
The 10-K add-ons at the end include "financing" (toxic by the way) that is darn near right up until the present. Page F-41 covers right up until Feb 19th of this yr. Look a the amounts- if they didn't put that cash on the books ASAP, that $40K or so they are showing now would have been ZERO. GOOSE EGG. 2014 (Jan $32,500 + Feb 10th $32,500 + Feb 19th $35K (Daniel James: a new one, will have to look up who they are) = 32.5 + 32.5 + 35K = $100K dollars in early 2014 already (up to almost exactly one month ago). They are in DIRE NEED OF CASH obviously- dire IMO. You don't sign terms like those below for a lousy $100K unless you're paying bills day to day, month to month. No way.
Subsequent financing
On January 14, 2014, the Company entered into a Securities Purchase Agreement with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible note in the principal amount of $32,500 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on October 16, 2014. The Note is convertible into common stock, at Asher’s option, at a 45% discount to the average of the three lowest closing bid prices 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, interest and any other amounts owing multiplied by (i) 140% if prepaid during the period commencing on the closing date through 179 days thereafter. After the expiration of 180 days following the date of the Note, the Company has no right of prepayment.
On February 10, 2014, the Company entered into a Securities Purchase Agreement with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible note in the principal amount of $32,500 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on November 12, 2014. The Note is convertible into common stock, at Asher’s option, at a 45% discount to the average of the three lowest closing bid prices 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, interest and any other amounts owing multiplied by (i) 140% if prepaid during the period commencing on the closing date through 179 days thereafter. After the expiration of 180 days following the date of the Note, the Company has no right of prepayment.
On February 19, 2014, the Company entered into a Securities Purchase Agreement with Daniel James Management, Inc., for the sale of an 8% convertible note in the principal amount of $35,000 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on February 18, 2015. The Note is convertible into common stock, at Asher’s option, at a 47% discount to the lowest daily closing bid 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 at 150%, interest and any other amounts.
I don't see any "debt being paid off"? Where? Again, I haven't had time to do this a thorough read- but here is a "quick" analysis using just my on-screen calculator and a couple of key word searches. I see no indication of "major debt" being paid down- it's listed as almost exactly the same from last period:
Debt is essentially the same and cash only is up by about $40K at this point- noise level money IMO and that’s after diluting 73 MILLION shares in a single qtr. Mirror appears to have gone nowhere- that’s my 2 cent general summary read at this point- my opinions only based on what I alone am reading. (debt was $13.4 million in last 10-Q and is reported as $13,362,480 below from this 10-K)
10-K just issued:
At December 31, 2013, we had cash and cash equivalents totaling $46,227; our working capital deficit as of such date was $13,362,480. Our independent registered public accounting firm has issued its report dated March 24, 2014 in connection with the audit of our financial statements as of December 31, 2013 that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern.
The number of shares outstanding of the registrant’s Common Stock, $0.001 par value, as of March 24, 2014 was 420,920,157.
Previous 10-Q, from last qrt:
At September 30, 2013, we had cash and cash equivalents totaling $6,684. However our working capital deficit as of such date was approximately $13.4 million. Our independent registered public accounting firm has issued its report dated March 28, 2013 in connection with the audit of our financial statements as of December 31, 2012 that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern and Note 2 of our unaudited financial statement for the quarter ended September 30, 2013 addresses the issue of our ability to continue as a going concern
As of November ____, 2013, there were 347,175,310 outstanding shares of the Registrant’s common stock, par value $0.001 per share.
So how much total dilution occurred in a one qrt period? My math is below- that’s my calc, someone else may see it differently?
(420,920,157 – 347,175,310 = 73,744,847 shares diluted). 73,744,847/ 347,175,310 = .21 x 100 = 21% dilution in a single quarter- and IMO, I don’t have a clue what major accomplishment there is to show for it? They seem real good at selling shares and paying themselves and paying back interest and stuff on loans like Northstar- that’s the way I see it. As for the common shareholder and what they get, will get? Who the heck knows. THE BIG ONE, MIRROR- and it gets a “barely” passing mention again. TROUBLE ALERT for me on that one. Mirror used to be, was the “end game” the way I saw it. Now I don’t see it at all. It for all intents and purposes to me, appears stalled out and going nowhere, or they would have put info out about it.
So, are they an FDA product/approval company running “trials” , driving for Myocell their flagship to get across the FDA finish line, or have they morphed into some shmattering of a “medical tourism”, sell anything and everything “stem cells” all over the 2nd and 3rd world company or whatever? That’s the questions I have- and only are my opinions and my questions and mine alone.
Counter question to "the question"?
"Why did Mike tell us "institutional investors" were investing if this was so bad financially?"??
Any PROOF any "institutional investors" have put up dime one? Let me clarify the way I "parse" a lot of these PR/blog, very carefully worded (MY OPINION ONLY) statements- as in the one you quoted above.
Technically, ASHER is an "institutional investor". See how easy that is? That's the 100% truth. They are a "investment house", they are a licensed trader/broker and have "institutional money lending capabilities" and are a "professional investment firm" who gives cash for equity stakes under BRUTAL terms. But are they "institutional investors"- heck yeah, by every definition I'm familiar with.
So is the CEO statement "true"? Yes. Is it what many who follow the stock were "thinking" or perhaps "hoping" for when they heard "institutional" investors? I don't think so.
See? See how a "carefully", as in very carefully worded statement can "work"?
Death spiral, toxic financing appears to be continuing- right on into 2014, right up until just recently. I'm just doing basic searches to pick out highlight, key issues I look for in every report.
And man- the terms on these deals are BRUTAL IMHO, just for a pittance of cash. BRUTAL. Look at the share discount they get, the interest rate and then the early pay-off penalty of like 150% of face value. WOW. BRUTAL terms- worse than in the past. 45% discount to market, 8% interest and now a payoff penalty (don't remember pay-off penalties in the past, maybe something new, more brutal from old Asher and the boys?). Wow, all for $30K lousy bucks or so at a time. Man- that is like worse than loan shark money terms IMO.
Just did a search on "Asher" and got to the financing area of the report: From page F-41
Subsequent financing
On January 14, 2014, the Company entered into a Securities Purchase Agreement with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible note in the principal amount of $32,500 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on October 16, 2014. The Note is convertible into common stock, at Asher’s option, at a 45% discount to the average of the three lowest closing bid prices 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, interest and any other amounts owing multiplied by (i) 140% if prepaid during the period commencing on the closing date through 179 days thereafter. After the expiration of 180 days following the date of the Note, the Company has no right of prepayment.
On February 10, 2014, the Company entered into a Securities Purchase Agreement with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible note in the principal amount of $32,500 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on November 12, 2014. The Note is convertible into common stock, at Asher’s option, at a 45% discount to the average of the three lowest closing bid prices 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, interest and any other amounts owing multiplied by (i) 140% if prepaid during the period commencing on the closing date through 179 days thereafter. After the expiration of 180 days following the date of the Note, the Company has no right of prepayment.
On February 19, 2014, the Company entered into a Securities Purchase Agreement with Daniel James Management, Inc., for the sale of an 8% convertible note in the principal amount of $35,000 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on February 18, 2015. The Note is convertible into common stock, at Asher’s option, at a 47% discount to the lowest daily closing bid 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 at 150%, interest and any other amounts.
"going concern" warning INTENSIFIED- this is a new one I don't think I've ever seen or read in their past reports? They've added an "emphasis" (my words, definition) to their going concern issues. Quoting, page 26:
"Current Adverse Economic Conditions have had a negative impact on our ability to obtain additional financing. Our inability to obtain additional financing would have a significant adverse effect on our operations.
In early 2008, as the United States economy began to weaken and there were increased doubts about the ability of borrowers to pay debts. Housing values began to fall and marginal loans were first to default, triggering the sub-prime lending crisis. Financial institutions responded by tightening their lending policies with respect to counterparties determined to have sub-prime mortgage risk. This tightening of institutional lending policies led to the failure of major financial institutions late in the third quarter of 2008. Continued failures, losses, and write-downs at major financial institutions through 2013 intensified concerns about credit and liquidity risks and have resulted in a sharp reduction in overall market liquidity. The global credit crisis threatens the stability of the global economy and has adversely impacted consumer confidence and spending. We believe this global credit crisis has also had a negative impact ON OUR ABILITY TO OBTAIN ADDITIONAL FINANCING. As discussed above, our inability to obtain additional financing would have a significant adverse effect on our operations, results and financial condition."
THAT is "interesting" to say the least. I don't believe I've ever seen them add that additional verbiage before about "tightening" of credit or more "difficulty" in continuing to get financing? And now you wonder perhaps why insiders cashed out debt for equity shares in swaps? Interesting IMHO. Very interesting.
This is going to take hours to read cover to cover and dissect anything new/unusual.
If it ain't in the 10-K/10-Q, my opinion is it doesn't mean a thing. The 10-K is the LEGAL DISCLOSURE and is fiduciary and binding. Someone can blog, PR till the cows come home- which is par for this group IMHO and then everything "mysteriously" is never spoke of, or heard about again, especially in the 10-K or similar. I've searched for stuff announced in past PR's in so many 10-Q's, and never found a word or mention of it again. That's been my personal experience and are my opinions only. The fact you didn't find any of these far, vast reaching "deals" in the 10-K does not surprise me one bit or even raise my eyebrow anymore. I'd would have been surprised if you did find any of it in there- that's my 2 cent take and past experiences.
MASSIVE DILUTION- and it was said there would be "none to little" in a previous post.
The number of shares outstanding of the registrant’s Common Stock, $0.001 par value, as of March 24, 2014 was 420,920,157.
From the last 10-Q to today was about 347 MILLION shares to now 420 MILLION which I stated near to the mark in previous posts. Spot on correct to what I estimate from the trend.
Cash and cash equivalents on balance sheet: $46,227.00 total dollars. Yep, over 60 MILLION shares dumped, and all that's left is $46K cash on the books.
"We have also initiated the MIRROR trial, which is a Phase III, double-blind placebo controlled study for centers outside the US. The SEISMIC, MYOHEART,MARVEL and MIRROR Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. Upon regulatory approval of MyoCell, we intend to generate revenue in the United States from the sale of MyoCell cell-culturing services for treatment of patients by qualified physicians."
THAT IS IT- when I did a search on "Mirror"- pretty much a GOOSE EGG NOTHING comes up. WOW !! I'll verify with a cover to cover read- but the search feature usually doesn't miss much? Wow, is all I can say.
I'll read the rest of the report in detail- but it's par for the course so far IMO. A typical BHRT 10-Q/10-K. Massive dilution, almost no cash left, and little to show for it. I'm going to look for every "deal" announced and other key info. Will post later after I get time to read every line.
I'll link to the post that said "no dilution".
Totally agree largely on FDA and especially on something like ADVIL- more people die from "bleed-out" due to NSAIDS than died in Afghanistan in a yr- but they hand it out like candy.
Regarding publishing in journals- gotta say the jury (IMO) is still out on that- from reading so far.
http://clinicaltrials.gov/ct2/manage-recs/resources#InternationalCommittee
International Committee of Medical Journal Editors (ICMJE)
Clinical Trial Registration. Part of the ICMJE Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (" ICMJE Recommendations "), which is followed by more than 1,000 journals. The ICMJE Recommendations encourage journal editors to require that ALL clinical trials be entered in a public registry before the start of participant enrollment, as a condition of consideration for publication.
WHO (ICMJE) - ClinicalTrials.gov Cross Reference (PDF). Table mapping the WHO Trial Registration Data Set, as required by the ICMJE registration policy, to the corresponding data elements in ClinicalTrials.gov.
ICMJE Frequently Asked Questions About Trial Registration
Journals Following the ICMJE Recommendations. A list of journals who have contacted ICMJE to request listing as a journal that follows the ICMJE's Recommendations.
http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
(seem REAL CLEAR here as these are the editors- the gate keepers if you will, of every major journal out there)
"Briefly, the ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. Editors requesting inclusion of their journal on the ICMJE website list of publications that follow ICMJE guidance should recognize that the listing implies enforcement by the journal of ICMJE’s TRIAL REGISTRATION policy."
That's just two references saying that- I found several more written by several other sources saying the exact same thing.
On the humorous side a bit- when I was googling, this site with the photo came up.
Look at that stack of "submissions" (back in the 60's, I'm sure it's worse today)- imagine wading through that stuff all day and trying to remain sane and awake w/o using copious caffeine, lol !
Wow.
http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SummaryofNDAApprovalsReceipts1938tothepresent/default.htm
A picture is worth a 1000 words, or lines of scientific "study" boring reading. Holy smokes- reading those stacks would be mind blowing, but interesting at the same time depending on what the new drug/process is and what it was attempting to treat.
Interesting how the NDA numbers were so high in the past- then sharply dropped off- and now have been more or less constant/flatlined it seems? Bet the cost created by the FDA is one of the main, driving factors? Is the FDA really our friend and helper?
I can easily see an English teach/prof migrating to regulatory- it makes sense. Lots of detailed writing and good communication skills, attention to minutia and minute details as laid out in very specific rule books (like trying to write a paper following the APA or other formats- I went practically insane doing it). As you stated- it's like the FDA is the boss, runs the show- whether you like it or not, and then you gotta play ball by all their rules/regs no matter how onerous they may be, and then answer everything to their liking, cross all "t's" and dot all "i's" just the way they like- it's a real skill and takes patience I'm sure.
It's easy to see why so many of these companies and commentators feel a lot of what our FDA does now is sorta run off the rails and has become a nightmares unto itself, while maybe not really protecting us near as much as people think, while at the same time stifling the things that really should be approved. I think that's why so many are calling for major reforms. But it's tough to dismantle or change a behemoth govt agency once it gets to big and powerful and becomes a "thing" unto itself. I think Leonhardt is sorta of fighting this cause, among others like financial stuff.
I'm gonna wait for the 10-K at this point since it's so close- wait and see what the big picture update is at this point and of course, be looking for Mirror info.
Just posted some links (long reads) along the same lines. The journal publishing part seems pretty clear-cut from a couple of the articles- as in the committee of editors "mandated" it, a while back.
Two of the links though were in conflict- as in one saying you still need U.S. based data ultimately for full FDA approval here. The other one stating there has been "limited", as in some drugs/devices approved now where all data was done outside U.S..
Interesting to say the least- but complex as heck, that much is for certain. I knew that already- dealing with the FDA is 2nd in complexity bar none. I don't even think the FAA or IRA is more complex, difficult to navigate. That's why there are people in FDA approval/regulatory positions, "hired guns" who make entire 20 or 30 plus yr careers out of doing noting but working for company's or as contractors or for contract firms in FDA interface and navigating the approval process- people with maybe a engineering or bio-science background, then maybe a MBA or law degree and maybe even another advanced degree or two tacked on- maybe even an M.D. or Ph.D. also. It's complex stuff to say the least. I've seen the info cited before - that a phase III, final FDA submission for approval can run THOUSANDS pages long, just a staggering undertaking, and then reviews and approval can drag on for year(s) often.
http://www.forbes.com/sites/theapothecary/2012/04/25/how-the-fda-stifles-new-cures-part-ii-90-of-clinical-trial-costs-are-incurred-in-phase-iii/
http://www.fiercebiotech.com/topics/fda_approval_process.asp
Of 5000 compounds discovered in the pre-clinical stage, only about 5 will make it through the entire FDA approval process. (WOW !)
New Drug Application (NDA)/ Biologics License Application (BLA)
If the drug proves to be safe and effective, the company then files an NDA or BLA with the FDA. NDAs and BLAs are typically 100,000 pages long and include results of human and animal trials as well as information on how the drug is manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug. However, there are cases when approval can be accelerated.
(100 THOUSAND pages of documents, again, WOW !!)
Trials abroad- real interesting read. I was still wondering, if you do a trial outside the U.S., does the FDA "recognize" it as "enough" to allow you to submit for approval here. I decided to google some terms like, "off shore medical trials" or "trails outside U.S." and got a bunch of good articles. The following one I think is the best- the guy writing lists his resume at the end- and he knows what he's doing. He points out at the end of the very long article, that even though you've done a trial outside the U.S. and gained approval from that country's regulatory body- you still will need a U.S. based trial for our FDA to grant you approval, ultimately- that's my take/read on his conclusions. Which is an eye opener for me. As it means the off-shore stuff is just step-1, as in "trying" to open a marketplace, but if you want the granddaddy big "approval", meaning FDA, you still have to come back here and do it here inside our borders and get our FDA approval based on that data:
http://www.mddionline.com/article/study-abroad-tips-successful-clinical-trials-outside-united-states
"Effectively Positioning Technology for U.S. and European Trials
While the U.S. Food and Drug Administration (FDA) and the European Union (EU) ultimately require data on patients within their borders before issuing FDA clearance or a CE mark respectively, a trial conducted abroad in a credible manner can give a company a running start to securing regulatory approvals these markets."
Several articles under those google search terms, also seemed to strongly indicate that registering the trial on the .gov web site is still the standard practice and norm, even when it's being done outside the U.S..
http://www.janssenrnd.com/our-innovation/clinical-trails
http://www.nytimes.com/2009/02/19/business/19clinic.html?_r=0
http://www.esternmedical.com/information/article21.php
http://www.ncbi.nlm.nih.gov/books/NBK50886/ (very interesting below- it says committee to be published in a major medical journal, more or less mandated trial be "registered" on .gov site)
Clinicaltrials.gov
The Food and Drug Administration Modernization Act (FDAMA) of 1997 mandated the creation of the clinicaltrials.gov registry for efficacy trials in serious and life-threatening conditions and interventions regulated by the FDA. Developed by NIH’s National Library of Medicine (NLM) in 2000, it allows interested parties to find information on both completed and ongoing clinical trials. The database includes federally and privately supported clinical trials, and study sponsors are responsible for submitting timely and accurate information about their studies.
The database registered a modest number of clinical trials in its initial years (Figure 2-1). A dramatic increase in trial registration came in 2005 in response to the newly introduced International Committee of Medical Journal Editors’ (ICMJE’s) requirement that studies published in their journals be registered in clinicaltrials.gov or other equivalent publicly available registries. The Food and Drug Administration Amendments Act (FDAAA) of 2007 created a legal requirement for the registration of trials of drugs, biologics, and devices, generating a modest increase in the registration of trials over what had been seen in 2005. Given the increasing number of trials registered on clinicaltrials.gov over time, the database encompasses a broad spectrum of research organized by study sponsor (industry, government, and nonprofit), disease and treatment being studied, and trial design.
Lastly was this one- a REAL LONG READ, but interesting, in that it said that indeed, there has been "some" as in a limited number of new drug candidate/devices approved now by the FDA where the entire patient set and trials were done totally outside the U.S., though it appears it's still not accepted or preferred as the "norm" and certain countries seem to carry more weight than others- most notably W. European, as of course their standards and methods would be most closely aligned with U.S. practices. As you can see if you choose to read it- this FDA approval stuff is daunting to say the least, as in mega-complex and daunting. I can see why it takes a big staff normally, and real experts with mega-FDA-regulatory experience to navigate the gauntlet. It's real complex stuff/laws.
https://www.law.upenn.edu/live/files/2257-wilson34upajintll6412013pdf
Interesting- we'll see I guess.
Just saw on BHRT "trials" tab on their web site that Mirror does indeed have a label, "Up to 35 sites OUS". So, guess that "OUS" is an official position then- N. America but no U.S.. So that answers part of the question(s).
Still, not sure if it relates to not registering the trial though if the "end game" is indeed, full FDA approval of the trial results and ultimately FDA stamp of approval to market/sell the product/process inside the USA? And again, if registering on clinical trials.gov relates to ability to get published in major journals, still seems pretty dang important? Again, real question seems to be, WHY NOT register it - there seems to be no downside, other than you must pass "approval/review".
Good info- thanks for digging in on that. But let me please raise a few questions per last part of the statements:
1) Is it a definitive "given" now that Mirror is "outside U.S. now to save money"? I don't know if that's an "official" company PR and given position, is it? The original Pr regarding Mirror was that is as follows: "The MIRROR trial is fully funded by Bioheart and will be conducted at up to 35 centers in North and South America. The trial is designed to enroll up to 126 patients over a 12 month time period. The first patient has been enrolled in Mexico at the Hospital Angeles with the Regenerative Medicine Institute (RMI). This study will complement the data completed in the Phase II/III MARVEL trial on patients with congestive heart failure (CHF)."
I see the words NORTH and SOUTH America? I don't remember any official company statement that Mirror is now outside U.S. exclusively (N. America being Canada, U.S., Mexico, Central America)? But did BHRT ever say, the U.S. is excluded in this Mirror trial- I just don't remember that being officially stated anywhere? Could be wrong- but is that true and a blanket statement now?
Also, I don't think the FDA cares where you're doing the trial nor do publishers of medical journals- if you want it to be in the "big leagues" - from what I read on that .gov site, you register it. Again, I don't get any implied statement when I read that site that says in effect, "Hey, if you're doing your trial/study/data collection off-shore/outside U.S. borders, but still want FDA approval in the end, or major med journal publication, then just skip all this registering and getting the NCT number assigned stuff".
I'm just not getting that in my read of it? The way I read it- if you want to come back here one day, and sit across the table from the FDA and seek their approval of your product, then they want it done their way, in their system and all- no matter where you're collecting your data, etc. That's my read on it. I'm not sure how/why those concluding statements were made at the end of the post- seems like a pretty broad, lose interpretation of what they sent back? Again, that's my opinion.
Just the implications to how it could/can hinder your possibilities at being published in major journals, too me, is enough reason alone? In other words- WHY NOT REGISTER? It's free, it's relatively simple it appears- unless of course they didn't get granted approval by the reviewing committee(s), including the live human one? Other than that, what's the down side to registering? It's a win to be registered with no down side that I can see? Again, why register this "Macular" whatever trial, but then drop your big, flagship, phase II/III trial off the board? WHY? For what possible reason would that be a good choice/decision? I guess I'm still not buying the "it's outside the U.S." or the "it only helps to enroll people, we don't need it, it's voluntary" - it doesn't pass the smell test to me.
Last update we got was one, one single patient enrolled and that was from July last yr. If it was being tracked/updated on the .gov web site, seems we would know more, or the updates would have to be more timely.
Also, I'm still not sure what to make of that last part of the PR from the "one enrollment" announcement- it's odd to me, as if mentions FDA "hold" and "reviews" and so forth, and I don't think BHRT ever really answered or explained that in detail- not that I'm aware of?
"July 02, 2013 15:37 ET
Bioheart Announces Phase III MIRROR Trial for MyoCell Initiated
The FDA has placed a hold on the request for an Expanded Access protocol using MyoCell in part because the proposed expanded access study would likely interfere with the clinical development of MyoCell and/or interfere with developing market approval. Bioheart intends to continue enrollment in the MIRROR trial while hold items are addressed with the FDA. In addition, Bioheart plans to initiate part 2 of the MARVEL trial using the J&J MyoStar™ Catheter to deliver MyoCell to CHF patients."
That verbiage to me is confusing? They say they "intend to continuing enrollment"? As if the trial might be "on hold"? And then what ever happened to the Marvel, part 2 J&J and so forth? I don't think that's ever been mentioned again, has it?
More questions, than answers from my end? But that's me?
Personally, I wouldn't use/trust a bellsouth.net email address for any "official" corporate or other business communications- especially as related to a public traded company.
Company's in today's day and age maintain corporate owned/maintained web sites, and they do it for a reason. They also, nearly always list on said corporate site, the official path for "contact" or "corporate" communications. It's almost always (99% of the time) going to be an extension of the corporate web site domain name. When you have a main domain name, you get granted a block of email address to go with it- usually a 100 or more on even a "basic" web host plan. For $6 buck a month, the "daddy" site will host your web site and you get 500 email addresses to go with it, yep for $6 a month. In other words- when a biz or corporation has or pays to have a web site built and either a) hosted on their own servers or b) pays a legit hosting service a fee to host the site on their secure servers- you will always be granted a large block of email addresses to go along with that web site.
For example- all communications with Amazon will be in some form like servicedesk@amazon.com or investorinfo@amazon.com. All emails will end in the company web site domain. It's one of the common ways to spot a fake or phishing scam email from large companies. I've gotten things like replycustomer@4google.com or similar. That "4" being inserted is what makes it a 100% fake/phishing email.
The BHRT web site lists the following under the "contact" tab- and that's the only one I'd use/trust, again IMHO. bioheart@bioheartinc.com
Notice, it ends in the bioheartinc.com which is exactly what their main domain name is. That means it's a corporate owned, verified email address.
Sorry, but anybody can create a joeblow@bellsouth.net email via being on a bellsouth account. Not saying it's real or not- just VERY "uncustomary" for a company CEO to communicate on what, at best, would be a "personal", non corporate official email account. Again, the "standard" industry practice would be xyz@bioheartinc.com and EVERY email for every person or contact inside the company would be under that format.
My humble 2 cents.
Post previous listed link(s) direct to clinicaltrials.gov that explained a WHOLE lot more than that. Further, it does not mention "recruiting" or "enrollment" in that wording. It mentions to "provide information". More important though, would be journal publication, ethics, human trial review board and a whole host of other reasons explained very clearly on the .gov site. Links provided already in other posts.
Well, 21 days from first patient enrolled was what, about 6 months ago? Not sure what the question is/means?
Seems important to me to be on .gov site as a registered trial, and several posts just listed links that explain why- using the .gov site's own wording. Including a section specifically titled, "Why Should I Register and Submit Results?"
http://clinicaltrials.gov/ct2/manage-recs/background
That's a more informed, clear explanation than I've read in any post? Seems pretty clear to me and straight from the mouth of thee govt. agency itself- no middlemen or "interpretation" seeming to be needed?
I'm not "implying" anything- just stating facts and an opinion, which I'm 100% allowable and a legit thing to do.
Citing the .gov own web site, the statement "website is used for recruitment and general information purposes. " is 100% incorrect.
Previous post, posted the links to .gov site- it involves FDA LAW among other things when human subjects are involved, it involves being published in medical journals, it involves "ethics" (the sites own wording) and a whole host of other things. It does not, according to the site involve "being used for recruitment" as one of its primary or main purposes.
That's using the .gov site and its own info- which I trust a whole lot more than a potential private email from the CEO of a public traded company- when no one else appears to have been given the same, "material", pretty important info in many people's opinion. To be registered and listed on that site or not, is not a "trivial" matter for a major phase II/III trial seeking FDA approval- and that's not my opinion, that's based on what the .gov site ITSELF says and claims. Read the site and the FAQ and other info on it such as, "Why should my trial be registered/listed"- very informative reading.
Posts that "claim" to speak for the CEO or "the company" to me, are always suspect- when no one else has read or seen that same info publicly released. That's my opinion.
Reading clinicaltrials.GOV site- seems to me, you'd want to be registered if your trial is to be taken seriously?
http://clinicaltrials.gov/ct2/manage-recs/faq#charge
Note this line specifically under FAQ (cut n pasted):
Can I register a study after it has started, has closed to recruitment, or has completed?
Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.
See FDAAA 801 Requirements for more information.
That sounds kinda important to me- as in, if you want publication later in major medical journals, sounds like they want your trial to be "registered" and issued the .gov tracking number and all? That's the way I read that verbiage above?
Again, strictly my opinion. But being published is huge, big in anything medical- it's what makes your work "peer reviewed" and more or less "legit" when the day comes.
Also, on the clinicaltrials.gov web site- read this section called, "WHY should I Register and Submit Results"- sounds pretty convincing and important to me:
http://clinicaltrials.gov/ct2/manage-recs/background
"What Is the Purpose of Trial Registration and Results Submission?
Registering clinical trials when they begin, providing timely updates, submitting summary results, and making this information publicly available fulfills a number of purposes and benefits a variety of people."
Read the table of info that follows that- pretty important stuff to me, especially for something like a "Phase II/III" and it doesn't mention A THING about "cause it helps recruit" and "we have enough people so we don't need it" or similar? It lists a whole bunch of, what sound like real, real important reasons to me, why a company with a major, serious FDA type trial would most certainly want it registered/approved on the .gov site. NOTE: Under FAQ link above- it notes that if human subjects are involved- the trial must be submitted AND "approved" by a review committee to be assigned a trial tracking number and appear on the .gov web site. Kinda important I'd think?
Quote cut n paste from same page .gov web site:
Why Do I Need To Register My Trial and Submit Results to ClinicalTrials.gov?
Required by Law
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices. For more information:
See FDAAA 801 Requirements to learn about Responsible Party, Applicable Clinical Trials, and deadlines for registration and results submission
See the Protocol Data Element Definitions and Basic Results Data Element Definitions to learn about the specific data elements
See History, Policies, and Laws to learn about other relevant laws, including the Food and Drug Administration Modernization Act
View the online presentation
Key FDAAA Issues (9:23)
Deborah A. Zarin, M.D., Director, ClinicalTrials.gov, NLM
Discusses key issues in the Food and Drug Administration Amendments Act related to registering trials and submitting results.
Required for Journal Publication
The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for the publication of research results generated by a clinical trial. ClinicalTrials.gov is a registry where organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE.
See ICMJE section of Support Materials or visit http://www.icmje.org.
Selected Trial Registration Laws and Policies
A summary of key laws and policies requiring clinical trial registration are shown in the table below:
I find that reply vague/weak in my opinion. You go to the BHRT webt site and under the "clinical trials" tab they list 5 trials. Angel, Marvel, Mirror, Myheart and Regen. You then go to clinicaltrials.gov site and what I find under a search of "Bioheart" is Marvel (described as active- not recruiting) and something called Biowhittaker going back to 2006, then what appears to be "REGEN" maybe - it's last update was back in 2007 and then Pulmonary Disease one they created in Jan 2014 (see, they list that but not Mirror, why?) and then the Seismic one with last info/update, again clear back to 2007 and finally the Dry Macular one created in Dec 17th 2013. So they list that "Dry Macular" thing, which isn't even their forte or supposed main focus, but Mirror is not registered?
Makes no sense to me- there is no agreement between the BHRT web site "clinical trials" tab and the clinicaltrials.gov site. Then certain "new/small" trials are registered at .gov while Angel and Mirror don't even appear? Confusing to me to say the least. WHY would you register some, but then give the explanation that others don't need to be registered, cause you know, "It's voluntary and all and helps recruit, but we got plenty of recruits, blah, blah, blah?" I'm not seeing it. Again, why does everything they seem to do have to fall under the vague and inconsistent "umbrella"? Always bothers me- just my opinion.
Then you have this PR from clear back July last yr, which is confusing to me to say the least- it's the one that mentions "one" and "the first" patient being "enrolled" in Mirror, and taking place down in Mexico, but has all this other verbiage about it "might" um "conflict" and some kind of "hold" with the FDA on something else- but Mirror will continue to "enroll" (not necessarily go forward) as these "issues" with the FDA are "worked out"? Again- confusing as all heck to me. Then in the meantime- you get the medical tourism "stuff", you get the ED, erectile "stuff" you go back to a phase one of 5 people called Angel in Mexico when you were all the way to a phase II/III in the same product line? And ALL THIS with what was listed in last 10-Q as 4 full time people I think it was? And we know one of those is the CEO and one other is the sole, "Chief science officer"? It seems just running one, one single major trial would be more than one "Chief science officer" could handle- and she's also listed as the "CEO" of Stemlogix, and as a active managing member, CSO of "Ageless". I mean- come on, there's only so many hours in a 24 hour day.
Here is the last big Pr I saw on Mirror- and it's confusing to me- I don't really think the "we don't need to be on clinicaltrials.gov" is a great explanation- again in my opinion only and the way it "rubs" me- which is not confidence building or positive. You have nothing to lose by being registered on .gov- and every major company conducting major FDA type trials seems to be on there- so why not just put the "trial" on there? What's to lose?
Here is PR with "hold" and "conflict" wording and all the rest (note- we're talking NINE months ago now):
July 02, 2013 15:37 ET
Bioheart Announces Phase III MIRROR Trial for MyoCell Initiated
SUNRISE, FL--(Marketwired - Jul 2, 2013) - Bioheart, Inc. (OTCQB: BHRT) announced today the successful enrollment and randomization of the first patient in the Phase III MIRROR Trial using MyoCell® or muscle derived stem cells.
The MIRROR trial is fully funded by Bioheart and will be conducted at up to 35 centers in North and South America. The trial is designed to enroll up to 126 patients over a 12 month time period. The first patient has been enrolled in Mexico at the Hospital Angeles with the Regenerative Medicine Institute (RMI). This study will complement the data completed in the Phase II/III MARVEL trial on patients with congestive heart failure (CHF). Patients are randomized into either the treatment (2/3) or placebo (1/3) arm. All patients will receive delivery into the damaged areas of the heart using the MyoCath® Catheter. Data endpoints will include safety, exercise capacity, quality of life, and ejection fraction at 3 months and 6 months. Kristin Comella, Bioheart's Chief Science Officer, said, "We are hoping to achieve results similar to those from the MARVEL trial in which patients improved almost 100 meters over placebo in their exercise capacity test. We believe this therapy can address an unmet need for cardiac patients."
The FDA has placed a hold on the request for an Expanded Access protocol using MyoCell in part because the proposed expanded access study would likely interfere with the clinical development of MyoCell and/or interfere with developing market approval. Bioheart intends to continue enrollment in the MIRROR trial while hold items are addressed with the FDA. In addition, Bioheart plans to initiate part 2 of the MARVEL trial using the J&J MyoStar™ Catheter to deliver MyoCell to CHF patients.
Again, my own experience- and that's just me and my opinion perspective- is these guys put out a lot of "PR" and "blogs" and other "stuff" that somehow, just never seems to materialize later or move forward, or be spoken of in detail again later in a 10-Q or similar. I've seen it over and over again. Notice the last line in the PR above- about Marvel being "initiate part 2 with J&J blah, blah"- meantime, they do Angel instead, medical tourism, and 5 or 10 other things and it's almost a yr later- and we haven't heard much about Mirror, let alone some "Marvel part 2 J&J" taking place or advancing? I just find them scattered all over the map (literally geography wise) and spread across so many things- it seems impossible they could ever complete one of them with the staff/money they have? I just don't see the end game or where's it's all going? 4, maybe 5 full time employees- none of who have ever brought a major FDA approved product to market- and they're doing all this stuff from Mexico to Honduras to the Middle East to running multiple FDA "trials" and all? Really? I don't know- I sure got my doubts. I practically have to build a spreadsheet of all the PR releases, what they said they would be doing and where on what date, when, etc and then "try" and see if we've ever gotten any updates later on most of them, any revenues, any progress, etc. It's that complicated to me- to even keep track of.
But that's just me. If others want to get all excited about a PR about every 2 weeks or so- to each his own. I just see it all getting more "scatter shot" and convoluted and "off message" with each passing day? Oh, and that's not even mentioning Stemlogix and all the "animal" stuff they used to mention- what ever happened to all that? Oh well- we'll see what the 10-K says, it's the next "biggest update" coming down the pike. See what it says- and if all this "stuff" is mentioned and described in detail?
Interesting. I'll check it out and give a watch. Didn't think the film went that much into all that. That's right up my alley of interest.
Have you ever seen "Man On The Moon" with Jim Carrey? It's the life story of famous comedian (and REAL weird guy- Andy Kaufman who went from stand-up comedy to playing on TV series "Taxi" among other things).
It's a great flick- won't do a give-away, film wrecker in case someone hasn't see it and wants to. But in it he seeks "treatment" down in one of the, to say the least, wild "clinics" in Mexico. Very well done scene. That film is an old fave of mine- Jim Carrey to me, when he plays other people is brilliant, he literally became Kaufman and the film is funny as heck too boot.
Check it out too.
What's in "Dallas Buyer's Club" that would make you think I should watch it? I have not seen the movie? I haven't paid much attention to films this yr. If I remember the guy is sick/gets sick HIV or something?
What would be in the film related to what we discuss here? Thanks.
Well I hope so- the name is BIO HEART, as it seemed that heart applications was always the end game, and of course FDA approval if in any way possible- the big, huge end game payoff.
Just see what I'm saying - they seem to sure be getting off (use an old golfer term) "in the weeds a bit"?
I just hope Mirror is not stalled out. 10-K is the big, next update- so we'll see. Just seems like relatively few resources, chasing more and more of a scatter-shot approach. Old approach seemed more intense focus, stay on target and go for the goal line in the cardiac, FDA "trial" arena?
Just throws me off a bit, that's all.
Again, my experience is it is rare for the "patient" to PAY A LARGE ($5000.00) fee to participate in "research". Usually, it's the other way around- you are actually paid compensation to participate in the trial (time, travel and even a daily fee for your time/effort).
Again, it's just my opinion- but charging $5K a pop for a "trial" sounds more like a money maker, than actual "research". They also toss around the word "treatment" a lot in that PR. Again, do date, there is only one, one FDA approved stem cell "treatment" in existence that I know of. Also, that "Repair Stem Cells Institute" is another one of these "things" that appears to be nothing more than a web site and a rented office suite. They state- they are basically an "advocacy" group to promote stem cell "whatever" and "wherever" - whatever that means? They make all sorts of claims that stem cells "treat" all these numerous conditions- nearly every serious illness in existence, but according to the FDA that is not the case at all? Just go to the pull-down tab on that web site and look at "conditions TREATED by stem cells" - it's like a wash list of every malady known to mankind and wreaks of a vitamin or snake oil like hype IMO. Just under the "A" tab is alzheimers, ataxis, autism, arthritis, ALS (Lou Gerhigs), anti-aging, etc, etc- I mean come on, you gotta be joking. There is ZERO proof that stem cells "treat" any of those conditions?
Just doesn't rub me the right way, and again- why do this now and where is it supposed to lead? To a phase I or II or what? What happened to Mirror? Who of the 5 or so employees is "working" on all this "stuff" from Honduras to ED to now diabetes to also being a CEO of Stemlogix and Ageless and all the rest? How can so few people, with so little money possibly be doing all this and where is it all supposed to lead or what is the end game?
Only my 2 cents again, but I just don't see it or get it. More like attempts to keep the stock mo-mo pumping going than anything else to me. But that's just me. A
Obviously? Can you please point that out as a fact? It's not even clear from the Pr who's doing what, where and how? It seems BHRT is providing the cell extraction and culturing part maybe, then this TC outfit or whoever they are, are doing the "treatment/procedure" in a place called "somewhere" as far as I'm reading - and charging $5K a pop minimum to each "participant"?
Help us out here if you can parse and decipher the exact wording differently, please. I'm just getting a lot of confusion reading it. It does not seem like BHRT is actually sponsoring or leading or the one "doing" the "trial/treatment" or whatever it is, but is a "co-participant" in it with other people and taking place "somewhere"?
Not clear to me at all- again, just my read on it. Sorta confusing?
Misleading headline in my opinion. "Researching" or "studying" something is NOT "treating" it, as there are no approved "treatments" here (USA) via the FDA or in Europe or any major, developed nation that we are aware of, involving stem cells and type 2.
Further, I'm always suspect and leery of "studies" where the participants are charged a large fee ($5K or more) in this case, to "participate". All credible, legit research studies (medical) that I am aware of- are paid for by the company doing the research or a govt. grant or a major university hospital and endowment or similar. When the suffering patient has to pony up cash- then I don't see it as a "study" IMHO.
This to me just falls under the ole medical tourism banner or a variation thereof. It doesn't really say if the final act of "treating" (injecting the cells) is going to be done off-shore or not? I'd think that this can not be done on U.S. soil without being a full, FDA type trial- which it does not appear to be from what I get from reading that PR.
Just my take on it. I don't think this kind of stuff if helping BHRT. I'd rather see them stay on message and track with major, FDA compliant/registered, actual "trials" like the Mirror trial (the big one- the one everyone thought was "it" and the end goal/game).
I just don't get where they are going with seeming to dip into everything from ED (erectile dysfunction) to eye issues to now diabetes to Honduras to who knows what? It's getting more and more confusing to me. Strictly my humble opinion. Where is Mirror? How can ONE Chief science officer and maybe 4 or 5 full time employees manage and oversee what, what must be 10 or 15 different "undertakings" now at this point? Just Mirror alone is enough to consume every dime and every waking hour of a mid-sized pharma or similar company- meaning probably a staff or 50 or more people and $10's of millions of dollars.
Not seeing it guys. Just not seeing it. Waiting for that 10-K I guess. This PR doesn't do much for me personally.
Agree- your version of "reading the 10-K" is pretty much an exact copy of mine. I'll read page one for present share count and compare to last 10-Q. Go down to balance sheet and look for "cash and cash equivalents" on hand. Then start reading the "financing" activities section to see if, what you describe as "toxic financing" is still going on, and how much- as in "convertibles" (that is the magic word). I usually open the 10-K in my browser and use the "search" document function and just search for every instance of "convertible" and read those lines first.
Also agree- getting those revenue "channels" and streams flowing is no slam dunk or easy undertaking. Will take time to build up to the $250K or $300K a month or so they need just to hit there day to day cash flow needs. So, will look for updates on "tourism" and other deals and did any revenue come from them yet.
Yep- good summary of how to read/examine this 10-K. I'll pretty much be doing the exact same "scan/read" method you will use.
We're all waiting for it- wanna see where things are at. If expectations are too high right now, it might let some air out of the tires. If it's got some good news in it- then we'll see. Oh, and of course we'll all be looking for Mirror. That will be the other key word I'll do a fast search on after I open the document. That's a big one- everybody is waiting to see what that one says. When I read the last 10-Q, I gotta admit I was a bit "miffed" to say the least, that the Mirror sorta got a boiler-plate at best, kinda passing mention. That sorta blew me away. I did a double check and researched the document- but it just wasn't there. It was near word for word what was in the 10-Q prior to that. So that Mirror is the big one that I think everyone is waiting to read too. Yep. We'll see.
Cash on hand, shares sold and new share outstanding count, financing activities- how much, what type, "toxic" or not; new business deal/adventures generating any income or not, and MIRROR. That's it in a nut shell for me.
Well, pretty much agree- "twitter" can go both ways. It is what it is- a communication "tool" that blasts out 140 characters at a time and any tom, dick, or harry can be on it, in under about 30 seconds of sign-up time.
Just saying- I'd go easy on putting too much behind "tweets". Not knocking it 100%, just saying I'd not put it as the end all, be all. Think of it as just another tool- maybe in the old days it would have been an email tool and real old days a newsletter or something. See what I'm saying?
I personally, again, just my lousy 2 cent opinion, think "twitter" like most "fads" will pass. As I stated, I already know young people who think Facebook is dead and buried, who were now on twitter but are jumping off it in droves and now it's snapchat and instagram and if you look- there's about 20 new (literally) start-up, "hot" trending variations on all of thee above picking off users. The latest is services where you form your own sorta little "private" groups now- the old trend was be as public as possible, now the kids/teens wanna go secret and private. Very fickle.
So, tweeting is a tool. I think they are in PR "push" mode and just testing the waters on using all these tools- like putting out "tweets". Remember, you can tweet all day long, but it doesn't bring in cash or make the biz a success or sell things at the end of the day. I know very successful businesses and they don't give a rat's behind about "tweeting" or anything else- they just run and work their businesses hard like they always have and build sales and profit the hard way- face to face, shoe leather on the ground, pounding the phones, etc. Lots of tools out there- tweeting is just the latest variation on them. Again, my 2 cents.
Not knocking it one way or another- it obviously reaches some people as you are a perfect example. You've read the tweets and it gave you some info to ponder. So from that stand point- it has "worked" to some extent and served some purpose. What it does for the biz in the "big picture"- I think is harder to know or measure. So, tweeting to me is not too exciting or doesn't move me too much one way or another- but we're all different and like different things, ways of communications. I-Hub is a perfect example- kinda a "private" way to discuss stocks, yet public. They built a little "community"- very similar idea to tweeting and facebooking, etc. Lots of "stuff" out there for communicating today- to each his own. Good luck.
Only problem with that is, I don't believe there's ever been a single indication that the "private placement" (carefully worded to say "up to" $20 million) ever went anywhere.
All indications from each 10-Q has been that BHRT has been doing nothing but paying "Northstar" back money as interest and loan/debt payments. And most recently, I believe that all, Northstar insiders are converting out some of the debt to equity (recent SEC docs posts showing how many shares each one got).
So I don't know what to make of that? Personally, I've seen BHRT put out a lot of similar PR/statements in the past, only to never hear of them again, or see anything materialize from them- just my take on it, but I've made that observation many, many times with these guys. In other words, search deep in the 10-Q's and see if any mention of that "private placement" or any specific new "capital funding" has ever shown up since that PR/blog about Northstar "private placement"- I don't believe you will find anything. In fact, as stated, it's the other way around- BHRT has been paying back to Northstar each period.
The only "funding" sources I'm aware of have come from direct sale of shares by BHRT to various "finance houses" and that's what's accounted for the outstanding share count rising by over 100 million shares in less than the past 9 months or so. I can't find any other source really of money injected than that by reading the SEC docs?
The idea that Northstar could go out and "easily" raise a chunk like $20 million or so in the investment climate of the past few yrs would be daunting to say the least. The value of BHRT market cap has not even been close to that amount until only the past few weeks and the climate for capital raising has been tough, other than using debt because interest rates are so low. But to use debt, you have to have assets which they really don't have. I know people in the "private equity" biz, these are guys with unbelievable pedigrees: like Stanford undergrad at top of class on full scholarship, then ran various businesses as CEO/buy-out specialist for a while as a "turn around expert" then Harvard MBA, published author, been on CNBC (woke up one AM - and there he was on TV with a new book he wrote being interviewed, I was like- I KNOW THAT GUY), rubs elbows in the D.C. area and Georgetown with filthy wealthy people and the politically connected, etc. I ran into him fairly recently as I know his brother and I asked him how "the biz was, and was going" and his exact words were "it's tough and tough sledding right now and not like it was back in the go-go days". He recently sold off a mansion (literal mansion- Architectural digest featured and all) and has down scaled a bit- flying commercial first class versus private jet, $3.x million dollar home after selling the $10.X million dollar home- you know, really cutting back lol. When he comes into town to visit his family- he's always in a rented Range Rover or BMW SUV or something, goes and plays golf with key people (always doing business no matter where he is- and he was a near pro level golfer, Stanford golf team n full ride scholarship on golf)- it's "elbow rubbing" endlessly in the "capital raising biz"- this guy's rolodex (modern cell phone contact list) must be an amazing site to look at. He shows up in socialite mags and newspapers throwing a party at one of his mansion homes or with his artwork collection or wine tasting hosted event- and it's nothing but mega wealthy name dropping going on, people who can light their fireplace with money they're so loaded.
No knock against BHRT, but if you look at who's in charge of Northstar- the guy, as far as I can tell, has zero experience at ever doing a "private placement" and/or going out and raising significant capital. I won't name names, but you can easily look up which guy it is, and what kind of business he had/has and ran- it has nothing to even do with technology or bio-tech. So, how that kind of guy would just hit the streets, and approach high net worth individuals to raise a big chunk of money (which is what a private placement is all about- you have to approach people with certain, minimum net worths, minimum high income levels, etc)- how that guy could pull that off to me would be very surprising. As stated, the people I know that do this full time will tell you it's a brutally tough biz, and they rub elbows with the who's who, they run entire "funds" they build/raise for private equity and so forth and host endless mansion parties with the "in crowd" to get money sloshing around, etc.
So, I don't know that the "$20 mil Northstar placement" ever amounted to anything. Nothing I have read or seen tells me it went anywhere. That's my take on it- so I'd read that with a grain of salt IMHO. My opinion only- maybe someone else knows more about it- but I'd think if any of that money did come in, it'd be plastered all over the past 10-Q's, and I just don't see it.
A public traded company, when in "compliance" with basic "SEC" laws (SEC being the U.S. Govt Securities and Exchange Commission- the govt. body that regulates and enforces the laws of our public stock markets)when they are a "compliant" company- one key thing they do is issue/register/report certain important documents with the SEC.
Note- one problem with some "penny" stocks traded on the OTC- over the counter market or "Pink" sheets unlisted stocks market, versus the NYSE, New York Stock Exchange (nick name Big Board) or the NASDAQ, the other "big" stock exchange where "listed" stocks trade- one problem is that sometimes penny stocks no longer are "compliant" and do not file documents with the SEC properly. Not filing on time or in compliance is in fact one of several reasons that can get a stock "de-listed" from one of the "big boards" like NYSE or NASDAQ which are the most prestigeous and desirable places to trade as a public company. Whew- that's a long explanation, but anyway, that's it in a nut shell. One of the complaints, reasons you will here about why a company may not "want to go public"- is that the INSTANT they do, they fall under tremendous scrutiny and reporting laws governed by the SEC. Many remain "private" companies as they do not want all the hassle of reporting to the SEC. You can raise capital as a public company- but it comes at a big price of reporting, being legally bound, etc. I've worked for a company that had a $billion plus in annual sales and was still a private, essentially "family" owned company- 100 plus yrs old, and no desire to go public. They can run the company their way and don't answer to anyone but themselves, their employees, and if they have private investors- they only answer and report to them as agreed upon. Once public- a whole new ball game and a book of laws as thick as a phone book.
Good news is, that even though BHRT (Bioheart) presently trades on the "Bulletin Board" unlisted exchange as basically a "penny" stock- they, as a company, have made the choice and effort to remain "SEC compliant" and are still filing the necessary documents on time and as required.
So, the question what is all these words "10-Q" and "10-K" mean? They are the quarterly company report (the 10-Q) and the annual, end of yr company report (the 10-K report). It is the philosophy of the U.S. public markets- that as a shareholder in a company, you are entitled to know certain things about them, their financial info, certain business info, etc. That is what these reports serve to do. If they are of high quality, they are typically "audited" - meaning a neutral, 3rd party, licensed CPA or public auditor firm has gone over the document and also put their "stamp of truth" on it- saying that whatever the CEO or Chief Finance officer or others in Sr Mgt said in it, in deed is believed to be true and accurate. A CPA firm or similar, as well as, the CEO or whoever signs off on a 10-Q or 10-K is under a "fiduciary" duty to the shareholders that what is in the document is true and accurate- and it's not to be taken lightly as it can result in financial fines and, up to and including prison in worst case scenarios if lying takes place in reporting- and yes, people have gone to Federal prison for "cooking the books" on SEC documents (famous cases being big companies you probably saw in the news like Enron or MCI/Worldcom the phone/long distance company, Lehman Brothers- once a huge Wall St. brokerage and banking firm).
Anyway, that's what the 10-Q, 10-K is all about. It allows us, the common stock holder to read, and know a lot about the financial health of a company, it talks about current business undertakings, problems the company may be having, etc. It serves to allow you to help to perhaps invest and want to own shares in the company or not. It typically contains a "verbal" description written by Sr. Mgt, as well as, what in business is known as a standard "set of financials"- which any businessman/woman is familiar with and normally is made up of: a) A balance sheet- a "snap shot" of things like cash on hand, accounts receivable, cash owed on accounts payable- basically a summary of what a company "owns" and what it "owes". The most fundamental equation you learn in accounting 101, or MBA 101 is: Assets = Liabilities + Shareholders' Equity. That is what the balance sheet does. It totals out all the pluses the company owns, and all the debt it owes, plus shareholder equity and should balance out each side of the ledger. b) The next document in a financials is typically an Income Statement or "P&L" profit and loss statement, which is just what it sounds like, a statement of whether the company has income coming in, where it's coming from (selling product for example),etc and what is going out being spent, essentially sales or money coming in, versus money going out(sales or cash coming in versus costs/expenses owed going out) and is there a net "income" or a net "loss" for the business and c) A statement of Cash Flows- which is very important as it shows whether or not the company is "throwing off enough cash" on a day to day or month to month basis to pay it's day to day operations without borrowing or financing activities and similar.
That's a lot to swallow, I know. You may want to get an intro to investing in stocks book- many will have a good section on how to read and understand the basics of a company's financials and their 10-Q and similar SEC reports. A guru like Warren Buffet is so good, so experienced- he can "glance" at a "set of financials" and pretty much decide if the company is in good financial health, is in trouble, whether they have costs that are too high, or have finance problems, etc It's like the instant "snap shot" of the total financial picture of the business.
Here is a link to the BHRT documents. Most people use a service called "EDGAR" which is a main, public repository of all the SEC documents put out by public traded companies. Click on some and read through them- it will give you an idea what is in them. Scroll down and you will see the last "10-Q" and if you go back to March 2013 or so, you'll see the last 10-K, which as the other post pointed out, would actually be last year's (yr 2012) full yr report.
We are all chatting here so much about the 10-K that's coming because 1) It's due any day now if it's "on time" (the SEC sets dates per a company's fiscal yr as to when they need to files key documents- think sorta like taxes due by April 15th each yr for you and I) and 2) We all want to read about the latest financial health, or lack of, for BHRT- such as how much cash they have, how many shares of stock they may have sold to raise cash (known as diluting shares), is there new income coming in from some recent business undertakings they have spoken about, and latest updates that management will write to "tell us the story" in their own words of how last yr "wrapped up" for the business.
That's a long explanation- but explaining "what is a 10-Q" is a pretty complicated explanation to someone totally new to the stock markets. Happy learning and good luck. Here is the link to all of BHRT's SEC reports:
http://www.sec.gov/cgi-bin/browse-edgar?CIK=0001388319&action=getcompany